Harpocrates Speaks

More Than Just Infectious Excitement at Super Bowl 46

2012-02-08T16:34:00.000-05:00

This past weekend saw a huge annual event here in the United States: the Super Bowl. Two football (that's American football, not the rest of the world's football, aka soccer) teams face off to do battle to determine who will come out on top, and like Highlander, there can be only one. This event draws thousands of people from all over the country, and probably even some from around the world. It is, quite simply, an epic event. They even had a whole "village" erected in the middle of Indianapolis, this year's host to the game. The village provided over a week of activities, both indoors and out, for tourists and fans.

Where's rubeola? (Image by Mike Fender/The Indy Star)

But it wasn't just football fans that paid a visit. Something else had some fun in the village on Friday, February 3, two days before the big game.

Measles.

It seems that two unvaccinated teens were there while infectious. The Indiana State Department of Health has confirmed two cases of measles, with two more suspected. And this comes as worldwide measles cases are on the rise.

Think about this for a moment. You have a place where thousands of people, from many different cities, are all milling together and a virus that infects about 90% of those with whom the host comes in contact. Transmission is much more readily achieved indoors than outside, due to poorer air circulation. The virus can linger in an area for up to about two hours, remaining infectious even after the host has gone elsewhere. Outdoors, breezes can disperse any viral material pretty quickly, significantly lowering the odds that one could get infected. However, if you cram a lot of people in limited space such that they're passing very close to each other, there is an opportunity for the virus to infect others.

Imagine that you are one of the public health officials that discover this. Think of the task ahead of you: you have known measles patients that could have potentially spread the disease to thousands of people. Those people have all since returned home to their own states (or even countries). Tracking everyone down would cost way, way too much, so the best you can do is to alert the various state departments of health and put out public warnings that anyone who was at the Super Bowl and who is at risk for infection (i.e., never had measles and/or never received the MMR) should consult their physician.

Now, in the interest of truthfulness, I need to point out that, so far, the reasons the two teens were not immunized has not been reported. They may have had legitimate medical contraindications to the vaccine. My gut, though, tells me that we have a couple cases of vaccine refusal. This whole mess could end up very, very badly, depending on how many of the people at the Super Bowl Village were immune, either from previous infection or immunization. MMR uptake rates in the U.S. are, generally speaking, pretty high, but that has been on the decline recently, leaving more people vulnerable to infection. Anyone who was vulnerable and who came in contact with one of the infected could be the focal point of another outbreak in another city, especially due to the efforts of anti-vaccine activists who, despite protesting otherwise, aim to scare people away from vaccines.

New measles cases could pop up anytime in the next couple weeks. And if they do, then people in those areas will need to be vigilant for another couple of weeks, waiting and hoping that no more arise. The virus is most infectious before the characteristic rash appears, so those infected may not even realize they are sick.

If you were at the Super Bowl and are unsure whether or not you are immune to measles, call your doctor and see what, if any, steps you should take to protect yourself and those around you. Do not just walk into the doctor's office, since, if you are contagious, you may spread the disease to others in the waiting room; calling ahead can help ensure proper procedures are in place to minimize the risk to other patients. If you are sick, stay home.

The Super Bowl Village may have been just a few blocks of a large city, but we're all part of the larger human village. It is our responsibility to watch out for each other.

Contagion of Fear: A Review of The Panic Virus

2012-02-06T07:00:00.014-05:00

Several months ago, I took a look at Michael Willrich's excellent book, Pox: An American History. Pox examines the social and political climate of the early 20th century United States' smallpox epidemic and many of the anti-vaccination sentiments and governmental responses that made controlling the outbreaks so problematic. Many of the arguments used and fears expressed by our ancestors of that era are strikingly similar to the worries and claims promulgated by today's vocal anti-vaccine activists. But while the appearance is the same, the reasons today's activists came to their position is different.

Enter journalist Seth Mnookin, author of the blog The Panic Virus and the book of the same name. I recently had the pleasure of reading the recently released paperback edition of The Panic Virus: The True Story Behind the Vaccine-Autism Controversy, Mnookin's investigation into the origins of the modern anti-vaccine movement.

After providing a useful cast of characters and list of abbreviations used in the book, Mnookin grabs hold of your emotions and takes you into the lives of the people affected by the movement. On a morning much like any other, Dan and Kelly Lacek's son, Matthew, had complained of a sore throat and seemed like he had tired himself out wrestling with his brother. By the time Kelly returned home from work, her son had a fever and his breathing was shallow. The doctors thought it was probably a case of strep throat, but then his fever continued to rise and his condition grew worse. It wasn't until another, older doctor inquired if he'd had his shots the the reality of the situation became clear. Kelly's chiropractor had instilled in her a doubt and fear of vaccines, so Matthew had not received a number of immunizations, including Haemophilus influenzae type b, or Hib, a disease that had been all but eliminated in the U.S., but which, like many others, is slowly returning as people refuse vaccinations. The Lacek's story draws you in. Matthews decline in health to the point where doctors had to put him into a medically induced coma is heart-wrenching. I cannot imagine the pain of watching your child come so near death because of a disease like Hib. Fortunately, Matthew recovered.

Mnookin treats the Laceks with compassion and understanding. Throughout the book, whether he discusses the parents of a child infected with a preventable disease or the parents of autistic children, that same compassion comes through. And that is one of the great strengths of this book: even while he may disagree with their message, Mnookin reminds readers that even the most vocal leaders of the anti-vaccine movement are real people, that their struggles stem from very real and understandable emotions. Ultimately, the impression is that many of them are victims misled by their own and others' biases and mistakes.

That's not to say that the message of anti-vaccination groups gets a free pass. The Panic Virus soundly condemns the misinformation and unethical actions of proponents of the "vaccines cause autism" myth. Through meticulous attention to detail and extensive research (the book contains 62 pages of notes and a 39-page bibliography), Mnookin shows the origins of many of the claims made against vaccines and why those claims are false. Some are simply the result of the manner in which humans think and how we trick ourselves, while others are the result of deliberate fraud.

Mnookin's greatest criticism, though, is not for individuals like Andrew Wakefield or Mark and David Geier, who he says are easy targets, but rather the media. Time after time, the media has given a free platform to those who would spread misinformation. Everyone from Oprah Winfrey and Larry King to typically less naive personalities like Tim Russert have credulously given support to anti-vaccine activists, taking them at their word without challenge and often casting scientists in the role of heartless, callous villains in the struggle to understand autism. It is the media, in Mnookin's narrative, that deserve the most blame, and he makes a very compelling argument. Would the fringe, myth-based ideas of the anti-vaccine movement have such traction as they do today if they had not received such ready support from various media?

I only have a couple criticisms. While he mentions the Simpsonwood meetings (which are brought up quite often by anti-vaccine activists), he does not delve too deeply into the arguments anti-vaxers use about the meetings beyond Robert F. Kennedy Jr.'s misquoting of the transcript. Since anti-vaccine activists view the meeting as evidence of some vast conspiracy, it may have been interesting to see greater detail of how those other than RFK Jr. use Simpsonwood in their arguments. I also have to bring up one problem with Mnookin's characterization of the recent pertussis outbreaks in California. The impression one gets from his book is that the greatest single contributor to the outbreaks was vaccine refusal. While this may certainly be true for some pockets of whooping cough outbreaks, the waning of natural- and vaccine-acquired immunity also played a significant role. These are minor quibbles, though, and do not detract from the overall quality of the book.

All in all, The Panic Virus is well-written and nicely organized, progressing from an early history of vaccine development's successes and pitfalls to the rise of organized opposition to vaccines, and bookended with stories of parents of children affected by vaccine-preventable diseases. Mnookin provides additional useful resources, like the aforementioned cast of characters and common abbreviations, notes and bibliography, and an index. His writing is engaging and he treats his subjects fairly; this is not a book demonizing parents. You also will not find unabashed, gushing support for everything vaccine. In keeping with his adherence to the truth, Mnookin readily acknowledges and criticizes those in public health and government for their errors. There is a lot to learn from The Panic Virus. In the end, this book provides a very good introduction into the major players in the anti-vaccine movement and serves as a history for how and why such a movement has developed.

Of Wood and Woo

2012-02-01T07:00:00.005-05:00

I've done some work as a carpenter. If you have never done it, you should give it a try. You can get lost in the work. Measuring, cutting, assembling. I've built sets for plays, taking simple pieces of wood and shaping them into imaginary lands that transport the audience into a different world, a different time. There is a simple sort of pleasure in woodworking: the feel of tools in your hands, the focus on the project. All of the stresses and annoyances of everyday life fade into the background. True, there are other pressures there. Get the structure done before first tech rehearsal. Finish painting and dressing the set before first full dress, or, when things really get down to the wire, before opening. There are also a lot of different issues revolving around personalities and egos, but all in all, those are relatively minor things with which to deal.

As I was reflecting on this, I thought of how there are some similarities to how we may interact with those with whom we disagree. When we argue with anti-vaccine activists, promoters of pseudoscience and so forth, there are techniques we use to make our point, to convince others.

Brute Force

Perhaps the most common problem facing a carpenter is warped lumber. Whether it's the frame of a platform or a flat, twisted boards can be a pain. Making joints flush, keeping angles square. The easiest way to fix it is to put a long pipe clamp on the offending board and torquing it into position long enough to fasten it with nails or screws. It usually gets the job done at least well enough, but it puts a lot of stress on the boards, the fasteners and the frame as a whole. While we might fix the joint, the overall frame may become warped, necessitating further forcing of the set piece to fit properly. But there may be no other option. You have limited supplies and need to make do with what you have. Applying brute force to make your materials behave will get you to your goal, albeit with some frustrations.

In a similar vein, when we come up against someone making somewhat warped claims, using the strong leverage of logic and evidence, we may try to clamp down on some core belief and wrench it to align with reality. Just as forcing the warped board puts everything under stress, this approach may get the job done well enough, earning grudging agreement, but it places our interlocutor under stress - dealing with cognitive dissonance, possibly straining friendships or other relationships they have with their support networks. While we may have won a particular argument, we may increase the amount of work before us, creating additional arguments or dilemmas to be overcome. In the end, a brute force approach can get the job done, but it can cause headaches and frustration for all involved.

Shimming

There are many instances where two pieces don't quite line up properly. Adjoining walls may be a bit off square or not exactly plumb. Abutting platforms have ever so slightly different leg lengths. Doors frames are often built smaller than the opening in the wall. We use shims to fill the gaps, to bump up corners and to create tight points to secure one element to another. They are a means to get around imperfections that might otherwise prevent the set coming together in alignment.

We're all human, and despite our many differences, there is often some sort of common ground. Take, for example, parents of autistic children who have come to believe many of the myths about vaccines put out by propaganda organizations like SafeMinds, Age of Autism or the National Vaccine Information Center. These mother and fathers may hold beliefs at odds with science, but they really want one thing: to do the best for their children. We have the same goal. That can serve as a common cause, a point for connection that, while it may not necessarily resolve all of the conflicting arguments, can serve to facilitate communication. From that understanding, more constructive dialogue can move forward.

Measure Twice, Cut Once

Sometimes, you're rushed or just plain tired. You make your measurement, cut your board, then find that you measured wrong. If the board ends up being too big, you can just make another cut to make it fit. If it's too short, you may find that you have to start all over; that board will no longer work for the task you had planned (though it may be useful for other frames that need a shorter piece), and you need to get a fresh one. There are a number of reasons this may occur. Perhaps you measured to the wrong point on the measuring tape. Maybe you measured to the right point on the tape, based on your calculations, but the calculations were wrong. Whatever the cause, you end up creating more work for yourself and possibly even losing materials.

When arguing a point, we sometimes misjudge our audience. Something we say, either the words we choose or the manner in which we utter them, rubs our listener the wrong way. If we're lucky, all we need to do is take a measure of them again, fix the way we're arguing, and then they get our point and end up agreeing with us. If we really blow our estimation of how they will respond, we may end up totally alienating them to the rest of what we have to say. They will shut down, stop listening and rationalize away anything that we have to say, no matter how valid, just because of how we presented our argument. So rather than doing a quick assessment, step back, take your time and measure twice.

Trim to Fit

I've had plans before me, carefully calculated out my measurements and created my cut list. I've planned ahead and given myself time to double-checked my calculations because, well, I've made the mistake illustrated above. But sometimes, no matter how carefully you measure, reality and theory (i.e., the drafting plans) don't always match. On paper, everything is straight, angles are exact. When you get to the actual materials, there are little imperfections: wood is warped, knots create bumps, your saw blade is just a partial degree off square or the steel box tube shifts a fraction of an inch while cutting it. In themselves, they may not amount to much, but together, they can skew the fit of things quite a bit. This is most pernicious when dealing with openings in walls (i.e., doors or windows). The way to get around this is to cut the face of your flat just slightly larger than the frame. Once you've attached it, you can go back with a router and a flush trim bit. The result is a nice, clean, flush edge; a perfect fit.

Sometimes it may be good to form your argument in broader terms. Get close enough to the point without getting bogged down in the nitty gritty details, where you risk overshooting your mark and souring your listener. Taking a looser approach gives you time to engage the person, and from there, you can hone the edge, refining the argument to perfection.

Hockey Sticks

Every now and then, you get a carpenter's worst nightmare: the "hockey stick". Hockey sticks are boards that are so severely warped (bowed, crooked, kinked or twisted) as to render it useless for anything other than playing hockey. Minor warping can usually be dealt with through brute force (see above), but hockey sticks - well, all you can really do with them is cut them into shims or dump 'em in the trash. These boards get like this for a number of reasons. Fast-growth trees generally produce wood that warps much more easily. Variations in moisture between point of origin and destination can lead to warping, as can storage conditions. But once a board warps to this degree, there's no fixing it without going to extreme measures. Go out, buy another board that you can work with.

Hardcore, dyed in the wool true believers are the hockey sticks of argumentation. They have drunk the Flavor Aid of woo, conspiracy and pseudoscience. People like this have generally invested so much of their persona and self-image into their belief that denigrating the belief is viewed as a personal insult. No matter what argument you put forth, no matter how strong your evidence, there's just no getting through to them. Nothing you say or do will change their minds, and, unless you're arguing for the sake of onlookers that could be swayed, it's probably best to just cut your losses and forget about engaging them at all. Find someone who might actually listen and engage in a dialogue.

Perfection

Few and far between are the times a carpenter (or at least, a theatrical carpenter) will find beautiful, straight, flawless materials and manage to actually precisely measure, cut and assemble them. When that happens, you just have to step back and take a moment to relish in the perfect finished piece before you. Square angles are truly square. Seems disappear into one another. Nothing sticks up or out unless it is supposed to, and you don't need to recut, use shims or trim anything. In those moments, an utter feeling of bliss and contentment can fill you, and you cherish it, because it can be so rare.

Every now and then, you come across someone who, before talking with you, held some bizarre belief totally ungrounded in anything remotely resembling reality. They were on the other side of the fence, but, they have an open mind. They listen to what you have to say. You don't need forced analogies (like ham-handed attempts equating argumentation to carpentry), you needn't reassess the arguments you're using or the way you're presenting them. The person listens, nods and says, "You know, I've never thought of it that way." You get into deeper discussion and find that you have much more common ground and agreement than either of you first thought. In the end, you leave satisfied in the discussion and possibly with a new friend. Cherish that. It doesn't happen often.

Blood, Sweat and Tears

Taking a set from paper to reality (or an argument from first words to conclusion) takes time and effort. It's fun, but it is also a lot of hard work. Sometimes, things don't go quite as smoothly as you'd like. Materials might not cooperate. You may miscalculate. You might get hockey sticks that you just need to throw out. But you pour yourself into the process and push through. You have one goal: to bring the set from ideas on a page to reality for the audience, to bring them something like this:

Click to enlarge

Dropping the Ball at Day Care

2012-01-27T07:00:00.000-05:00

For as long as humans have gathered in societies, perhaps even before we evolved into homo sapiens, we have engaged in the communal care of our children. Whether it is a collection of parents, sharing responsibility for the care and upbringing of the youth; a single parent caring for several neighborhood kids; or even modern professional facilities; to one degree or another, there has always been a need, on occasion, for a division of labor when it comes to taking care of infants, toddlers and older children.

Today, this most often takes the form of day care. The demands of working life lead us to put our trust in others to watch after our children while we go off to earn a living to provide for our families. The opportunity to stay at home, to spend time with our kids, is often a luxury that few can afford. This may be due to the necessity of simply earning enough money to pay for rent and other bills or the need to advance in our careers. Whatever the reason, there are many for whom day care is a necessity, and as such, we trust that those in charge will take appropriate measures and put in place certain rules to ensure the well-being of those under their care. We also trust that all parents who use those resources will abide by the rules.

When the system breaks down, the repercussions frequently ripple outward, affecting more than just one or two people who failed to uphold that trust.

Back in late November/early December 2011, one of the employees of a day care center noticed something wrong with one of the children. A two-year-old had begun developing pustules. The child was taken to a doctor, and samples were sent to a lab for confirmation of a diagnosis. Then another child developed similar symptoms. This was followed by the 6-month-old sibling of the first child, and then their older, pre-school-aged sibling. The day care had an outbreak of varicella, chicken pox (PDF), on its hands.

How could this have happened? All children attending the child care center, aged 1 year or older, were supposed to have been vaccinated against chicken pox (PDF example of typical requirements). Was this a failure of the vaccine? A faulty lot of vaccine? Did the facility knowingly allow the children in without their shots? Did the parents get a religious waiver for their children?

It appears that there have been no problems with any vaccines that children at the day care received. There were no waivers from the immunization requirements due to religious beliefs. And the day care apparently thought that all of the kids were properly vaccinated. So what went wrong?

The parents of the four children are allegedly pleased that their kids got wild type chicken pox, since it seems they harbor a distrust of vaccines and feel that infection is better than the vaccine. Based on reports, the parents faked the vaccination records of the three oldest children (the 6-month-old is too young for the varicella vaccine) so their kids could be admitted to the facility without actually receiving their shots. Compounding the issue is that it appears the day care center may not be exactly stringent in checking immunization records for validity.

Since only fatal cases of varicella are reportable (PDF example of typical requirements) to state health officials, investigators may never have heard about this little outbreak. The four infected apparently have had a normal course of illness without severe complications. Thus far, no other children at the center have been reported as being infected, though there is still a chance that they could get chicken pox, even if vaccinated, since efficacy against infection is about 80%-85% (though if infected, those who have been immunized will have their risk of moderate or severe disease reduced by 95%-100%).

However, more than just the children at the day care were at risk. Two of the center's staff were pregnant. One had been immunized, the other had not and did not recall whether or not she had chicken pox as a child. Because this second woman had unknown immune status, she was referred to an OB/GYN and given immune globulin to try to prevent any possible infection from taking hold, though this would likely only have protected the mother.

Varicella infection while pregnant can be quite dangerous for both the mother and the fetus. According to the CDC, about 10%-20% of infected mothers will develop varicella pneumonia, and of those approximately 40% may die. The infection can cause pre-term labor or even premature delivery (PDF). The mother may also suffer from respiratory distress severe enough to require intubation and ventilator support.

Image from CDC

The infection may also play havoc with the developing fetus. In about .5%-1.5% of cases, the fetus may develop what is known as congenital varicella syndrome. On the mild end of effects, the infant may be born with scarring or other skin abnormalities from the pox marks. More extreme, though by no means rare, effects, especially if the infection occurs during the first two trimesters, are low birth weight, uneven or incomplete physical development (e.g., a shortened leg or arm), mental impairments, nervous system disorders, impaired vision and so on. Infants thus affected can also look forward to bouts of shingles, which typically affects older adults, during childhood.

In light of these not insignificant risks to the pregnant day care staff, the magnitude of the situation should be clear. The combination of events (parents not immunizing their children and allegedly hiding the fact, the day care possibly failing to do due diligence in reviewing immunization records for their clients) highlights the community aspects of vaccination. Immunization is one of those things that is about more than just the one patient. As I have said before and will say again, any person's decision about whether or not to vaccinate themselves or their children has repercussions. It affects every single individual with whom the person comes in contact, even the unborn.

In the setting of the communal care of children, it is incumbent upon everyone involved to do what they can to protect everyone connected. Parents need to follow immunization requirements and providers need to ensure compliance. It takes a village, as the saying goes, to raise a child, and selfish or careless acts threaten not only the child, but the entire village.

Note: Names and locations have been omitted to protect the identities of the individuals involved in the outbreak.

Pertussis Toxin, Aiding and Abetting Influenza

2012-01-20T07:00:00.006-05:00

Pertussis, or whooping cough, is bad. In infants, it can kill or lead to neurological impairment or other permanent injuries. In adults, the 100-day cough can range from a persistent annoyance to bone-wracking agony. As bacteria go, it's a pretty nasty one. Less than two years ago, an outbreak in California resulted in the deaths of 10 babies. In the mid- to late-1970s, vaccination rates plummeted in many countries after reports of neurological damage following immunization, leaving the immunocompromised at much greater risk. The reports were ultimately mistaken. We are currently seeing another downward trend in vaccine uptake rates, as well as reminders that immunity wanes with time. Outbreaks continue to spread across the United States and other nations as teens and adults fail to get timely boosters and parents opt out of immunizing their children.

Avoiding the agony and loss of time, not to mention possible heartache, that accompanies whooping cough would seem to be a good idea regardless of any other factors. But a new study published in PLoS One hints at another reason to immunize.

A team of researchers from the University of Maryland School of Medicine, led by Dr. Victor Ayala, noted that viral infections, such as influenza, can be complicated by subsequent bacterial infection, leading to life-threatening pneumonia. A number of studies, they state, have looked at possible mechanisms that may contribute to increased severity of disease in these situations, but few studies have examined the reverse situation: a bacterial infection followed by infection with influenza virus. Given that as many as 30% of adult and 16% of infant pertussis patients exhibit evidence of a viral co-infection, Ayala et al. investigated the role that pertussis toxin may play in increasing or decreasing the severity of subsequent respiratory viral infection.

Bordetella pertussis, the bacterium that causes whooping cough, produces a toxin that enables it to evade the host's immune system in order to colonize the host's lung tissues. Pertussis toxin (PT) affects many of the signalling pathways that govern the immune response. Basically, it shuts down cell communication so the body doesn't realize it's under attack.

Imagine, for a moment, that you are a guard. If you see an intruder, your job is to first call for reinforcements, then get a nice, clear picture of the intruder so the enforcers know who to look for when they arrive. So you're sitting there, keeping an eye out. You see something suspicious, and as you reach for the phone to call it in, a sultry, seductive woman (or guy, take your pick) wanders up and latches on to you. She works her charm and your attention is hers to command. You forget about phoning anything in; heck, you can't even remember what the suspicious something you saw even looked like.

That's essentially what PT does. It prevents alveolar macrophages (the front line defenses against things that make it into your lungs) from signalling for help to fend off an invasion of foreign organisms. What's more, PT disrupts the ability of the innate immune system to "teach" T-cells what antigens to look for, a process known as antigen presentation. All of this appears to be a means that B. pertussis evolved to outfox the immune system, at least for a short time.

So what does this have to do with influenza? Ayala and his team, using mouse models, found that infection with B. pertussis prior to influenza infection resulted in much more severe flu than when influenza infection preceded pertussis infection. Hypothesizing that the toxin was the agent responsible for this effect, they set up a series of experiments in specially bred mice. Some were inoculated with wild type B. pertussis, some with B. pertussis lacking PT and others with PBS (phosphate buffered saline), a non-toxic solution acting as an inactive control. All of the mice were then inoculated with influenza virus. In mice affected by PT, the innate immune response was suppressed, allowing the influenza virus to replicate much faster and for a longer period of time than in either of the other groups. The result was a more serious bout of the flu, with significantly increased risk of mortality (PT-treated mice died much sooner than non-PT-treated mice). This only occurred, however, when the mice were inoculated with the influenza virus within several days following pertussis infection.

Ayala et al. hypothesize that the increased lethality may be due to several different factors. PT causes a short-term decrease in cytokines (cell-signaling proteins important for immune function). The resultant large viral load may be the reason that a respiratory viral co-infection is so dangerous. Alternatively, after the early low level, cytokines may increase significantly during later stages of infection, potentially leading to a cytokine storm.

Since this study was in mice, it may be difficult to accurately apply the findings to humans; we can't exactly go around purposefully infecting people with pertussis and influenza. However, it does provide a viable explanation as to why influenza infection (and possibly other respiratory viral infections) concurrent with or shortly after pertussis infection can be so severe. The authors certainly have interesting findings, and more research is needed. Bringing this all back to the issue of vaccination, immunizing against pertussis may not only prevent a survivable, if painful, several months of coughing, but it could potentially reduce the risk of a fatal case of influenza, as well.

Reference
Ayala VI, Teijaro JR, Farber DL, Dorsey SG, Carbonetti NH (2011) Bordetella pertussis Infection Exacerbates Influenza Virus Infection through Pertussis Toxin-Mediated Suppression of Innate Immunity. PLoS One. 2011; 6(4): e19016.

Defending a Fearful Magic

2012-01-13T12:30:00.001-05:00

I suppose that writers should, in a way, feel flattered by the censorship laws. They show a primitive fear and dread at the fearful magic of print.
-- Sir John Mortimer, Clinging to the Wreckage, p. 183

I've been debating with myself whether or not to write this post. In fact, it's taken me a very long time to put my thoughts down, and I've even held this post back even after I finished it. You see, a recent post of mine was received somewhat, shall we say, unfavorably by someone. I had put down my thoughts on some general rules to follow when writing things on the internet, whether it's in a blog, comments on a newspaper article, Facebook, what have you. As some illustrative examples of what not to do, I included some screen shots of this individual's tweets and other comments, but never actually used the person's name in my own composition, though she did identify herself in the comments, later on. In fact, she left her comments only minutes after sending me an e-mail.

I had tried to inject some humor into the post as a means of keeping the issue light while still providing an educational point. But, as anyone who has done extensive writing or reading in the skeptical community, you can probably see where this is going.

The individual whose actions were at the heart of my post was apparently less than amused. In the wee hours of the morning of December 19, she sent me an e-mail with several claims and demands. After a salutation (IN ALL CAPS!), her very first demand was the complete removal of my post. Not just part of it, not just corrections. She wanted the whole thing nixed. Much like she presumably sent her comment on an LA Times article down the memory hole, she wanted to do the same thing with my bit of prose. Not only that, but I was to remove all announcements and links to the post everywhere on the internet, as if I somehow had control over what other individuals chose to do with their web sites. If I did not comply, I was to, in her words:

FACE CRIMINAL AND CIVIL LEGAL ACTIONS [sic]

Her primary claims as to why I should pull the post were: copyright violations, trademark violations, cyberstalking, violation of her right of publicity, and defamation. Some of these claims we've heard before, most recently in the uproar over the Burzynski Clinic and the actions of one Marc Stephens in attempting to bully bloggers like Rhys Morgan and Andy Lewis into silence with similar legal threats. In fact, on the internet, one of the quickest response to any substantive criticism seems to be threatening the critic with a defamation suit.

At any rate, what finally convinced me to write up this post is that my experience could serve as a good educational example for would-be plaintiffs (i.e., another "what not to do" list) and defendants. So let's take a look at the specific claims made in the e-mail I received, whether there is validity to the claims and how to respond. Before we proceed, however, I want to make clear a few things. 1) I am not a lawyer. I do not present myself as a lawyer, and nothing I write here should be construed as legal advice. If you want legal advice, find a lawyer. 2) I emphatically do not condone anyone addressing this individual directly through e-mails, phone calls or any other means for the purposes of harassment. Public comments are welcome, but I ask my readers not to post any threatening comments toward this person. The point of this post is to discuss the legal issues raised in the e-mail.

Now that we have all that clear, let's move on.

Copyright Violations

Intellectual property is a rather fascinating area of law and one which touches on anyone who posts anything to the internet. Any physical thing that someone else creates is their property, whether it is a photograph, digital image or audio file, as well as anything they write. There are both legal and illegal uses of other people's property, and how they share the information can play a role in the determination of what is and is not acceptable use of their materials.

What were the allegations regarding my post?

First, you are violating my Copyright by publishing photos of me that belong to only me.

Second, you are violating my copyright - by publishing any words actually by me.

I did, indeed, publish words that she wrote, as well as her photo, which, at the time of my post, she used as her public Twitter avatar and Facebook profile photo. Was my doing so a violation of her copyrights? For that, we need to look at the copyright laws. If we do, we see that there are certain situations in which a person may reproduce another's work without prior permission, also known as "fair use". Fair use covers purposes such as "criticism, comment, news reporting, teaching, scholarship, and research" (17 USC 107 [PDF]). This section includes four factors to determine whether or not someone's use constitutes fair use or is an infringement of copyright:

the purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes;
the nature of the copyrighted work;
the amount and substantiality of the portion used in relation to the copyrighted work as a whole; and
the effect of the use upon the potential market for or value of the copyrighted work.

My original post was for commentary or criticism, rather than for any commercial gain or promotion of myself or anything associated with me. The screen shots depicted public comments, visible to anyone who cared to look for them at no cost. While I could have shown every single thing this individual wrote (e.g., all 100+ tweets sent from her Twitter account to Liz Ditz's Twitter followers accusing her of stalking and harassment), I only used enough to illustrate the points that I was making, and my use of the screen shots doesn't have an effect on the value of her words, since they were already freely available to one and all.

As far as her accusations of copyright violation go, from my perspective and understanding of what the above-cited U.S. law states, while it may have been polite of me to get her permission first, I was fully within my rights to excerpt her writing to illustrate the points that I made.

And a final point. Notice that she said "any words actually by me". She did not specify which words were hers. Indeed, in several tweets to various individuals, she gave the impression that Liz wrote the LA Times comment and put this woman's name and picture on it. Given this assertion, it would have been helpful for her to tell me exactly which words were hers so that, if I had actually been in violation of copyright law, I could have removed the specific text which was at issue. Therefore, if you are going to accuse someone of violating copyright, specify the exact text which was wrongfully copied.

Trademark Violations

Where copyright applies to larger works, trademarks apply to words, phrases or symbols. They are meant to distinguish one manufacturer and/or their products from another. Trademarks could be unrelated (in a logical sense) to the underlying product (e.g., the Nike "swoosh" mark has no logical connection, in and of itself, to athletic shoes), or they could be descriptive of the product (e.g., "Pearl Vision" describes eyesight-related services or products). The mark could have a secondary meaning, as well, one that describes a specific product (e.g., "Pearl Vision" is a particular vision care business, distinct from, say, "Vision Center").

Here is the accusation regarding my post:

Third, you are violating my trademark by using my name which is trademarked by me to describe the unique legal services I provide.

Frankly, I'm rather curious how her friends and family refer to her. Do they need to get her permission every time they say or write her name? At any rate, referring back to what I said earlier, we're dealing with a couple different meanings. On the one hand, her name refers to her as an individual, just as my name is associated with me and yours describes you. On the other, according to her trademark claim, her name has a secondary meaning that is specifically associated with her legal services.

It seems rather clear to me that I was referring to her as a person, not to her business or the services she provides as a lawyer. In fact, I only used her name in the screen shots themselves, which showed her personal comments, rather than any particular legal services she was providing to others. That said, even if I had used her name to describe the particular services she provides, I would still, to my understanding, be able to use her name to talk about her or her services, much like I would be able to talk about my dining experiences at McDonald's without running afoul of infringing on their trademark.

Out of curiosity, though, I paid a visit to the U.S. Patent and Trademark Office to verify whether she had actually registered her name as a trademark. Using their Trademark Electronic Search System and her last name as a search term in any field, I was unable to locate any pending or registered trademarks for her. Go figure.

In the end, given my lay understanding of how trademarks work, just like with the copyright accusations, her allegations that I infringed on her trademark appear to have no merit. So what's next?

Cyberstalking

Here's what she told me in the e-mail:

Fifth, you are participating in the crime of Cyberstalking, which under the Penal Code is a felony. I will pursue this as far as needs be and I am adding your blog to the list being given to the FBI. If you persist with keeping this blog up, you are knowingly engaging in cyberstalking because I am informing you to remove it.

Quite an accusation, this one. I admit, I was taken aback at being seriously accused of this. She threw it about a lot (and, in my opinion, recklessly and erroneously) in regard to Liz, so it isn't really a surprise that she would accuse me of the same thing. Still, it was very unexpected. Stalking is a scary thing, which can often turn into something far worse than simply being a nuisance to a person. It can frequently elevate to physical harm. At any rate, I felt I needed to find out just what the penal code of California stated, with regard to stalking. I was fairly certain I had done nothing that could be construed as stalking, but better safe than sorry.

Here's how California Penal Code 646.9 defines the matter:

Any person who willfully, maliciously, and repeatedly follows or willfully and maliciously harasses another person and who makes a credible threat with the intent to place that person in reasonable fear for his or her safety, or the safety of his or her immediate family is guilty of the crime of stalking, punishable by imprisonment in a county jail for not more than one year, or by a fine of not more than one thousand dollars ($1,000), or by both that fine and imprisonment, or by imprisonment in the state prison.

Let's see, I did not repeatedly follow or harass her, seeing as I had no contact with her other than my one post, which was not even addressed to her. No e-mails sent to her. No phone calls. No comments posted on her web site or Facebook page. No tweets directed to her. Nada. In my post, I made no threats against her or her family, and, as I stated above, I do not condone others doing anything of this nature. Seems to me that her cyberstalking claim is baseless.

If you do feel that someone is stalking or harassing you, contact your local authorities or a lawyer, accurately explain the actions you feel meet the definition of stalking or harassment and get their advice on what to do next. This is a very serious allegation, so do not fling it about simply because you're offended by something someone wrote. Make sure that what the person is doing really is stalking/harassment, since making this accusation without just cause can create a lot of problems for all involved, and going so far as to file a claim against the person when they are not actually doing so is a waste of law enforcement resources.

Right of Publicity Violations

This is something that I did not know much about until recently, when I was looking into whether or not to have my Quacktion Figures™ manufactured. It was fortunate that the issue came up prior to this e-mailed legal threat. Not only did I recognize the phrase and claim, but I actually had at least a modicum of knowledge about it. As my interlocutor writes:

SEVENTH, YOU ARE [sic] violating my right of publicity in using my name and likeness.

The right of publicity basically prevents the unauthorized use of a person's likeness for commercial purposes. Not all states have actually codified this right, but California has, in Civil Code 2233:

Any person who knowingly uses another's name, voice, signature, photograph, or likeness, in any manner, on or in products, merchandise, or goods, or for purposes of advertising or selling, or soliciting purchases of, products, merchandise, goods or services, without such person's prior consent, or, in the case of a minor, the prior consent of his parent or legal guardian, shall be liable for any damages sustained by the person or persons injured as a result thereof.

Here's the problem with her claim: there was no commercial aspect to my post. I was not advertising or selling anything, nor was I soliciting purchases of anything. The use of her image and name in the screen shots was incidental to the post.

If someone is using your likeness without your permission, and you think that they are violating your right to publicity, examine just how they are using your likeness first. Are they actually using your image to promote a product or service? Or are they simply offering commentary, to which your image is either tangential or used only for illustrative purposes?

Defamation

And so we come to the last of her claims:

AND LASTLY [sic], you are intentionally defaming me.

This is probably the most common allegation levied against skeptical bloggers. Those who find themselves the object of criticism, particularly when they are unable to adequately defend their statements based on facts and logic, seem to readily resort to this tactic. James Randi, Stephen Barrett, Simon Singh, Paul Offit and others have all been targets of such attacks, and there are many, many more writers who have pulled their posts in the face of such threats simply because of the costs associated with defending a legal case, even one which has no merit. Sometimes the pressure to cease writing on one's own time can even come from an employer as a result of threats of a defamation suit.

Each state has their own definition of what constitutes defamation (libel is written defamation, slander is the spoken form), but they generally include the same elements:

publication of a statement of fact
that is false,
unprivileged,
has a natural tendency to injure or which causes "special damage," and
the defendant's fault in publishing the statement amounted to at least negligence.

The best means for a blogger to avoid libeling someone is to stick to the truth where facts are concerned. For example, don't say that someone committed a crime unless they actually were found guilty of committing that crime. If someone claims that you are libeling them, should you choose to respond to them, Rhys Morgan's response to Marc Stephens is a great example of how to do so, asking his accuser to state the specific words that were defamatory and why. Working with the person in this way could help avoid the expense of hiring a lawyer and defending against a lawsuit. Of course, like Mr. Stephens, they could simply continue to demand the removal of the post completely, without specifying which specific statements were defamatory. That's a good clue that they are simply trying to bully you into silence.

If you think that someone is defaming you, run their words through the factors listed above. Are they making statements of fact or of opinion? If they are stating something as fact, is it false (e.g., they said you committed the crime of X when you did not)? Will their statement have a significant negative effect on your reputation, such that your business or social standing will suffer? Did they appear to make the statement willfully or without regard to the veracity/falsity of the statement? If so, it might be libel. Check with a lawyer. If you think that it is defamatory and your lawyer agrees, start by politely asking the individual to remove the defamatory text. And, as always, be specific! This may be enough to resolve the issue. If you can avoid taking things to court, so much the better. Legal battles are expensive and, if you are wrong about your claim, there's always the possibility that the other person will sue you back for their defense costs. Remember, comments that might be mean, hurt your feelings or paint you in a negative light do not necessarily constitute defamation. The best piece of advice here is, as with avoiding making a fool of yourself on the internet, think before you act.

Other Sundry Bits

Now, you may have noticed that there are some numbered claims/demands that I did not list in my quotes from the e-mail I received. That's mainly because the missing bits consisted of statements that had no relevance to any alleged wrongs. Number 4 stated that her comment was not on the LA Times web site, which is true. What she left out was that it was, at one time, on the LA Times site, as screen shots from multiple sources attest. Number 6 alleged that she was being cyberstalked by Liz Ditz and included a link to the site of a fellow who, it appears, made up a whole bunch of stuff. Number 8 was a statement that she helped set up a web site for a man with autism, as if that somehow exonerates her of the statements she made, much akin to the racist that says, "I'm not racist! I have a black friend!"

None of those things has any relevance to any perceived wrongs. If you're going to send legal threats to someone, stick to the things that actually relate to your claims. Extraneous stuff simply works against you, making you appear petty or whiny.

Then there was the closing statement (capitalization and punctuation as in the original):

I DEMAND THAT YOU IMMEDIATELY REMOVE THIS BLOG POST, ALL LINKS TO IT, ALL ANNOUNCEMENTS OF IT IN ANY LOCATION -- OR FACE CRIMINAL AND CIVIL LEGAL ACTIONS.

In Summary

The e-mail I received was full of accusations of various wrongful acts both criminal and civil, as well as threats that I would face legal action. Upon closer examination, none of the accusations seemed to hold any water. What's worse is that they were made by a lawyer. In my opinion (again, I don't know her or her history, so this is just my opinion), this either speaks to a sad lack of understanding of the relevant law, or suggests that knowing the law, this person felt she could attempt to bully me into silence. Either way, though I did not know anything about this person before this whole brouhaha developed, it did nothing to give me a favorable opinion of her as a person. She may be quite accomplished at representing her clients, but she did not make a very good impression with me in how she handles herself. Bottom line: if you're going to issue legal threats, make sure they would actually hold up in a court. Otherwise, you paint yourself as a bully or a fool or both.

Hopefully, my experience can give other bloggers some insight into what they may encounter if they comment on what someone says or does, as well as how they might go about responding. If someone accuses you of defamation or of violating their copyright or right of publicity, and you choose to respond, ask for specifics. Be polite and cooperative. Who knows, you may have actually crossed the line. Depending on the accuser, though, it may be best to simply ignore them. Or, you could seek actual legal advice of your own.

What Did I Do?

I asked some friends and other bloggers for advice on how to handle this e-mail. Some suggested I just ignore her. For myself, given the fact that she is a lawyer and actually brought out some claims that I hadn't really encountered before nor read about in other bloggers' accounts of legal threats, I decided to treat her e-mail seriously. I decided to go to lawyers that specialize in media, defamation and intellectual property issues. Perhaps I didn't need to, but I'm happy I did. A lawyer can help draft a response or advise whether you should take corrective actions on your posts. What's more, they may be able to reference court cases that establish a precedent applicable to your writings and which build on whatever laws you're accused of violating.

And a Final Brief Note for My Accuser

Lest you take offense at this post, please understand that my sole purpose in writing it was to hopefully help other bloggers out there who might find themselves the target of legal threats. I bear you no ill will. My personal advice to you is to simply let the whole thing slide into obscurity. Time, as they say, heals all wounds. But, if you feel you must comment, take the high road. Own up to your actions and simply admit that you may have been in error; you would garner far greater respect for doing so than you would by continuing down the path you started. Although I may not particularly respect you because of what you have done, I do nonetheless wish you the best in your endeavors.

To the rest of my readers, if you feel like commenting, I ask that you not comment about this person. My point in this post was not to vilify her nor to encourage others to do so. Please do not mention this person's name (barring her "outing" herself), insult her, threaten her in any way or discuss her. Of course, if my accuser chooses to comment on this post, my readers are welcome to respond, but I will ask that you keep things civil.

I feel that the topics raised in this post are important issues that face bloggers, especially those in the skeptical community, and deserve discussion. As such, I want to encourage lively commentary of these issues. Feel free to share your thoughts on how to approach these issues, best practices, personal experiences and so forth. If you have been on the other side of the coin, facing a post that was at least in your opinion defamatory, please share your comments, as well.

Addendum: Two more pieces of advice. If you are going to issue legal threats (whether valid or not), make sure you provide a current physical address (e.g., a P.O. Box that can actually receive mail) for any legal correspondence. Barring a physical address, accept PDFs of any correspondence as an attachment to an e-mail. If you have a Gmail account, don't claim you can't open attachments or files, since there's that little "View" link allowing you to safely view attachments like PDFs without actually downloading the file to your computer.

A Lesson from History

2012-01-12T07:00:00.002-05:00

There are many reasons people are opposed to vaccines. They may have some fear of needles, oppose them for ideological or political reasons, confused a coincidental change in health with a vaccine reaction or simply read and believed propaganda put out by anti-vaccine organizations like the National Vaccine Information Center, Age of Autism, SANEVax and so on. Whatever the reasons for their dislike of vaccines, a frequent question that they ask is, "If your kid is vaccinated, then what does it matter whether or not my kid gets his shots? If vaccines work, then you shouldn't have anything to worry about."

This is a very naive and simplistic question. I addressed this question a while ago and reposted it recently. After presenting some numbers showing what happens when people refuse immunizations, I briefly talked about some people from my own life who could be negatively affected, as well as some hypothetical talk about others that could be harmed.

Recently, a comment at Respectful Insolence brought up a story that I felt should be presented more fully. This is a story of a parent whose child could not be vaccinated and how declines in immunization rates affected the family. Due to the harassing nature of some anti-vaccine activists, identifying details have been altered.

The Setting

England. The summer of 1981. Only two years had passed since the end of the 2-year-long epidemic of pertussis gripped the country. After its introduction in the mid 1950s, the pertussis vaccine brought disease incidence to near zero. But after news reports raised the specter of neurological damage following vaccination, fear of the vaccine caused uptake rates to plummet from 79% in 1973 to a low of just 31% in 1978, a year after the epidemic began. According to the U.S. CDC,

The timing and magnitude of the epidemics, the age group (1-4 years) primarily affected, the fall in levels of vaccine acceptance, and the rise in the number of reported pertussis cases suggest a direct relationship between the decline in vaccination coverage and the occurrence of these epidemics. No other explanations, including socio-economic factors, satisfactorily account for the 1977-1979 epidemic (2-5).

Although the dramatic increase in cases from 1977-1979 stirred people to turn once more to immunize, uptake continued to lag, and another year long epidemic was just beginning.

Introducing James

James had been a sickly child from birth. Born with severe spina bifida and hydrocephalus. He required the placing of a shunt to allow cerebrospinal fluid to flow in the right direction and relieve the pressure on his brain. He also suffered from hydronephrosis, a condition where urine elimination is impaired, resulting in it building up in the kidneys, requiring a vesicostomy. Physicians advised his parents to avoid all immunizations and gave his mother drugs to make her milk dry up. His prognosis was so poor that the doctors went so far as to tell his parents to just go home and forget they ever had a baby.

Frequent urinary tract infections and shunt blockages had James in and out of the hospital where his father worked over the first several years of his life. Everyone knew him, and his parents became very skilled in determining what was wrong by his symptoms. James' parents whisked him off to the children's ward whenever he was ill and needed more attention than just the loving care of his mom and dad. With all of this good medical support, his parents, fortunately, did not have to mourn him.

The Blue Lips

The family had gone on holiday. It was a much needed break for everyone. A time to relax and enjoy being together without the stresses of daily life. At some point during the vacation, James developed a cough. At first, it was just a cough, nothing to worry about. But as time passed, it got worse and worse, until the family felt compelled to cut their break short and get James to the hospital.

Now, his parents were no strangers to the hospital. A visit to the hospital was a near daily experience. The nurses in the children's ward all knew them, and everyone knew what to expect. But this was different. His coughing had grown so bad that, for long stretches, James could not draw breath. As his father recalls:

By the time we arrived at the hospital James was coughing and coughing and struggling for breath. My most vivid memory is of his lips turning blue, which was very frightening. When James was examined, we were very surprised to be told it was whooping cough - pertussis. Even in 1981 this was a disease that I associated with the past.

James' father does not remember what specific treatment his son received. Antibiotics by that point would have done little other than prevent spreading the infection. It is most likely he was placed on supportive care, with medical staff working to minimize his cough and keep him breathing.

Looking Back

It's only in retrospect that James' parents realized that fear of the pertussis vaccine and subsequent drop in immunization rates very nearly claimed their son's life. They were fortunate. Pertussis kills anywhere from 1 in 1,500 to 1 in 500. James survived, but he and his parents went through a great ordeal all because unfounded fears of a vaccine allowed an epidemic to ravage the country.

James' story illustrates the importance of vaccination to protect those who be immunized. Had vaccination rates not declined, pertussis would almost certainly not have raged across the land, and James may never have been put through the trial of the "100-day cough". That was 30 years ago. This is today. The next time someone questions vaccines and asks, "Why does it matter whether I vaccinate or not", think about James and all of the other children like him. They depend on us to do our part to prevent the spread of vaccine-preventable diseases.

Further Reading:
Impact of anti-vaccine movements on pertussis control: the untold story (PDF)
Pertussis immunisation and serious acute neurological illnesses in children

A Moment for the Sublime

2012-01-06T19:19:00.000-05:00

Every now and then, you just need to stop and appreciate the world around you. After several days of hectic activity and stress, today offered a wonderful opportunity to do just that:

This picture really does not do justice to the real thing. For one, the colors aren't quite right. They were so much richer, stunning purples, oranges and reds. The bright spot where the sun is setting wasn't quite so distinct, and rising from that area was a region of relatively uniform width that seemed like the beam of a spotlight shining straight up. It was wonderful to just take a break from things for a moment to enjoy this beautiful, fleeting moment.

And, for those who enjoy chuckling at the paranormal, orbs!

Does this flash make my orbs look big?

Clearly, ghosts love to watch the sunset, too.

Quacktion Figures™ Will Have to Remain a Dream

2012-01-02T09:38:00.000-05:00

Back in November, I put up a survey to gauge interest in my series of Quacktion Figures™, created with the help of Lil Peck. Generally, feedback on the figures was positive, and I thought it would be great to have them produced. Personally, I would love to own one of each.

With the help of one of my readers, I looked at some companies that manufacture action figures to see how much it would cost. Turns out, action figures are friggin' expensive! There are some one-off shops that will produce very small batches of limited-run figures, but they tend to run into the hundreds per figure. Other companies can produce large batches, but they tend to have a minimum number of figures per order, like in the 2,000+ range. While the costs to those interested in purchasing one would be cheaper with the large-scale production route, I would really need to be sure that there was enough interest to make it worth my while. Otherwise, I'd be spending a lot of money to have hundreds or thousands of figures taking up space in my home.

And so, I did the survey. What did I find out?

It was a pretty simple design: one question to see if people would want to buy a figure or not, and another to see how much people would be willing to pay. In all, I got 34 responses. Five said they would not by one, 29 said they would. About half of those who responded said they would pay $20 per figure, with others willing to pay as much as $30 and others only $5.

Overall, the response rate wasn't exactly encouraging. From a cost standpoint alone, I'll need to leave the figures as virtual images only.

Phil Plait also gave me some very good advice about them: talk to a lawyer. While the figures are fine as virtual, satiric images on my blog, bringing in the commercial aspect introduces a whole new realm of issues to think about. It's one thing to use them for satiric commentary, another to actually market them. The biggest concern is that the figures are readily recognizable, leading to the potential for someone to claim that I am defaming them. There's also the issue of profiting from using their image without their permission. Some of the folks depicted might not take very kindly to such activity, leading to problems for me (and Lil) further down the line. This is especially troublesome when thinking about the types of individuals depicted; they tend to be of a more litigious bent.

Despite all the negative stereotypes about lawyers, they're really quite nice people. I managed to get some time to sit down and talk, in generalities, about the project with one. He was very professional and offered a lot of good points to consider. The very first thing he brought up was the legal issue of the right of publicity. In short, the right of publicity prevents others from using your image for commercial purposes without your permission. Even if I were to donate all proceeds to a charity, the person could still sue, as the charity may be one with which they do not want to be associated.

Now, there are some ways I could get around the legal issues, but it would involve significant changes to the figures as they appear on the blog. They may still have an entertaining element to them, but they just wouldn't have quite the same bite to them.

Given the legalities and the costs, it looks like real Quacktion Figures™ will have to remain a dream. But don't despair, they may be a series two in the future.

Vaccine Awareness Week: If Vaccines Work...

2011-12-29T19:22:00.000-05:00

I haven't had much time lately to generate new posts, but one thing I've noticed lately is that there is a certain anti-vaccine talking point popping up. So I felt it might be a good time to put up an old post again addressing this point.

So, without further ado, here is a post from November 3, 2010 talking about why pro-vaccine people are concerned about those who refuse vaccines.

"If vaccines work, then it shouldn't matter if I don't vaccinate my kid."

That argument, or some variation thereon, is fairly common among anti-vaccine folks and the parents who fall for their propaganda. The thinking is something like this: vaccine proponents claim that vaccines work; if they work, they must be 100% effective; if they are 100% effective, then my kid getting sick won't affect anyone that's been immunized; therefore, why should it matter to anyone else what I choose for my child?

There's a couple problems with this line of reasoning.

First is the strawman argument that vaccines are 100% effective. No one, especially not anyone in the pro-vaccine arena, claims that any vaccine is 100% effective. This fallacious argument also tends to be associated with the black-and-white thinking of the Nirvana fallacy, that if vaccines are not 100% effective, then they are completely worthless, so why bother? Vaccines vary in efficacy. Some are over 90% effective. Many are in the 80%-90% range, while some can be extremely low (e.g., the BCG vaccine against tuberculosis, with an overall efficacy of around 50%, a statistic which has not changed much over the years [PDF]).

Because vaccines are not 100% effective, there is always the possibility that an immunized individual is still susceptible to infection. Chris, a regular commenter at Respectful Insolence and other blogs, wrote up a brief comment that nicely illustrates how herd immunity works. I'll copy it here for ease of reference:

Take 1000 people (ignoring the infants under 2 months who cannot be vaccinated, or babies under a year who can only be partially vaccinated), if 5% refuse vaccines then the numbers are:

950 vaccinated persons (assuming full schedule)
50 unvaccinated persons

The pertussis vaccine is actually only 80% effective at worse, so the numbers are:

760 protected persons
190 vaccinated but vulnerable persons
50 unvaccinated persons

There is an outbreak and it gets spread to 20% of the population, then:

760 protected persons without pertussis

38 vaccinated persons get pertussis
152 vaccinated person who may still get pertussis

10 unvaccinated persons get pertussis
40 unvaccinated persons who may still get pertussis.

In Chris' example, we have a total of 48/1,000 who become infected and 192/1,000 who are still vulnerable to infection. What happens if immunization uptake drops further, to say, 15% refusal?

850 vaccinated persons (assuming full schedule)
150 unvaccinated persons

Continuing with the worst-case 80% efficacy of the pertussis vaccine, the numbers are:

680 protected persons
170 vaccinated but vulnerable persons
150 unvaccinated persons

There is an outbreak and it gets spread to 20% of the population, then:

680 protected persons without pertussis
34 vaccinated persons get pertussis
136 vaccinated person who may still get pertussis

30 unvaccinated persons get pertussis
120 unvaccinated persons who may still get pertussis.

This works out to 64/1,000 who become infected and 256/1,000 who are still vulnerable to infection. That means that increasing total refusal by a mere 10% results in a 33% increase in infection rate and susceptibility.

What does this mean for the anti-vaccine argument? It means that if an unvaccinated child gets infected with one of the vaccine-preventable diseases, they can spread the infection to an immunized child for whom the vaccine, for whatever reason, did not work.

All of this ignores, however, the fact that there are individuals who cannot be immunized at all. The decision not to vaccinate has an effect on those individuals, too, so the "if vaccines work" argument doesn't even apply. Here are a couple of the reasons that an individual may not be immunized:

They are too young. Newborn infants may not mount an effective immune response to a vaccine to provide lasting immunity if they are too young; the vaccine may have been studied and found not to be safe to give under a certain age; or, the vaccine may not have been studied in children under a certain age and consequently not approved for use in those ages.
They may have an existing medical condition for which there is a contraindication. The CDC has a Guide to Vaccine Contraindications and Precautions (PDF) that lists a wide range of medical reasons not to receive certain vaccines.

Choosing to vaccinate decreases your (or your child's) risk of being infected and passing that infection along to people in those two categories above, not to mention the earlier discussion about individuals for whom the vaccine just didn't work. I'll give a couple examples of why the two bullets above are important to me.

Before I get into that, though, it is important to note that many diseases are contagious before any symptoms appear and remain contagious even after symptoms abate. For example, influenza is contagious for about a day before any signs of infection appear, so it is possible to spread an illness even before you know you have one.

Now, onto examples from real life. Several of my friends and coworkers have recently given birth to beautiful little children. Like most people, I take joy in seeing these new additions to the world, and I really do not want to be responsible for any harm to them. By vaccinating, I reduce my risks of being infected and, therefore, passing the infection along to those infants. If I do not get vaccinated, I am at increased risk of infection, and I may, quite unwittingly, infect the newborn child of my close friend, possibly with rather severe consequences. That is a risk that I am not willing to take. I would rather not gamble with the lives and well-being of my friends' newborn sons and daughters.

I also have a friend who is a transplant recipient due to severe diabetes. Before the transplant, he was pretty much on death's door, requiring frequent visits to the ER for dialysis and resuscitation from heart attacks. He got a new liver and pancreas and the difference was like night and day. Instead of lolling to sleep in the corner, he became vibrant and talkative. He no longer needed regular doses of insulin, and visits to the ER gradually became a memory. The only down side is that he needs to take immunosuppressing drugs to keep his body from rejecting the new organs. This means that he is more prone to infection. Again, I really do not want to be responsible for him developing a disease that could very well put him back in the ER or even kill him. By getting vaccinated, I reduce that risk immensely.

There may be other people with whom I come in contact on a daily basis that may be just like my friend, but I might never know. It isn't exactly like they walk around with a big, neon sign above their heads flashing, "I'm particularly prone to infection and serious complications from disease." I may pass them in the supermarket. Perhaps I brush against them on the bus or subway. Maybe they're next to me in the crowd at a concert or play. It certainly would be unreasonable to expect them to stay sequestered away from all other people and not enjoy life. And so I take the responsibility to do what I can do to help protect them.

Finally, in choosing not to vaccinate your child, you are deliberately withholding beneficial medical treatment and increasing the risk of disease, along with the potential complications for someone other than yourself. Every individual certainly has the right to decide, for themselves, what medical interventions to follow. However, when it comes to deciding for your children, you are not deciding for yourself. Further, your children are not your property to do with as you please. You have a responsibility to ensure their welfare and do what you can to protect them from whatever harms can be prevented. Given that the benefits of vaccinating outweigh the risks, it is irresponsible not to vaccinate your child, barring legitimate medical reasons.

The decision to vaccinate or not vaccinate is not one that only affects the person receiving the immunization. It affects every person with whom they come in contact. (The only exception to that is tetanus, which is not contagious. If you want to risk tetanus, knock yourself out.) Whether you like it or not, you, and your child, are part of the herd, part of the community. Your decision has real effects on the spread of infectious diseases. Think of those around you: your friends, your family, coworkers, people you pass in the store. By vaccinating, you reduce your risk of being infected by any of them, and you likewise reduce the chance of spreading infection to them. By choosing not to vaccinate, you are choosing to risk not only your own health or the health of your child, but the health of everyone with whom they come in contact.

If you're interested in more Vaccine Awareness Week posts, there is are lists at Science-Based Medicine and I Speak of Dreams. You can also find more on Twitter by searching for the #vaxfax hash tag.

How Not to Make a Fool of Yourself on the Internet: A PSA

2011-12-14T22:56:00.002-05:00

It seems that there are people out there who may, perhaps, lack a certain understanding of just how the internet works. They may write some ill-advised comment which draws well-deserved criticism. They might follow this up with additional statements which serve only to attract more criticism, with a big ol' side of humiliation. Maybe they do not realize that in the internet, nothing is truly erased.

And so it is that I find myself here, offering up some advice to the poor, self-centered, crass, ignorant folk on the internet. Even though doing so may rob myself and other bloggers the entertainment of invoking the Streisand Effect, I feel that there are those who may benefit from some instructive illustrations.

Rule 1 - Think Before You Type

The internet is really a very powerful tool. It allows us to call up information on a wide range of subjects with very little effort. The speed at which things occur online urges us to give immediate voice to our thoughts. Now, our emotional sides simply love this arrangement. They get to dictate our reactions more frequently when we can just type a few words and click a button before the rational sides of our brains have a chance to say, "Perhaps you should pause to reflect a moment."

When you decide to comment on something online, it's a good idea, therefore, to stop a minute to consider what you plan on saying. Start by asking yourself if you actually know enough about the topic upon which you're commenting to, at the very least, avoid saying something incredibly inane. Taking this time to think things through also gives you the opportunity to consider whether your words might be insulting or insensitive to others who are personally affected by the subject.

If you take the time to think before you type, you might avoid saying something rude, ignorant and completely off-base like, oh, this:

Click to enduncenate.

If you do find yourself leaving callous remarks like this individual in the comments section of an article in a widely read newspaper, you might end up finding yourself the target of some justified and well-reasoned criticism like this, this or this.

Rule 2 - Don't Go Orwell

Perhaps you make the decision to write further on your Facebook page, maybe even going so far as to laugh at someone who was very upset by your comment. You might say some things like this:

Click to enboorify.

The combination of your initial post violating rule 1 and your subsequent posts on Facebook might draw a comment such as this:

Click to enlightenate.

After reading something like this, you might feel a sense of shame, perhaps even embarrassment. After all, someone has just shown that you were out of your depth on not just one, but two subjects. And all of your friends have witnessed it. You may ponder deleting that comment; simply erase the loss of face and send things down the memory hole.

Don't do it!

You will only invite further criticism that you are afraid to have an honest discussion, that you censor reasonable questions. In short, you add to your image as a shameless, callous, insulting individual the added bit of being a coward.

Rule 3 - Don't Deny You Said What You Said

The problem with breaking rules 1 and 2 is that, in the age of the internet, nothing is ever truly deleted. You might try to get rid of your original comment, your subsequent comments and the criticism you've received. But, well, just look above to see that someone, somewhere has probably already saved evidence of your nonsense. In light of this, don't try to fend off criticism by saying that you never said what you said:

It wasn't meeeee!

When you say stuff like that, you just look even more foolish when evidence that those words you're denying actually did flow from your fingers. Chalk up "liar" to the list of epithets that describe you, should you pursue this course of action.

Rule 4 - Don't Libel Your Critics

You might be tempted to really go off the deep end and start making even more ill-advised comments, ones that actually run close to, if not actually going over, the line of what is and is not legal. For example, you might be tempted to say something that would be considered libelous under your local civil codes (e.g., CA Civil Code 44), like this:

Spammity spam!

You see, accusing someone of crimes (e.g., stalking and harassing) and sending that message in separate tweets to everyone (or at least a large number, I got tired of getting screen shots after the first 100 separate, distinct tweets that were sent - anarchic_teapot has a storify post with a more complete capture of her tweet stream) who follows your critic on Twitter is what defamation lawyers might consider a bad move. That is acting with the deliberate intent of spreading false statements of fact that damage the image of the target. This behavior is what is called libel. If your target so chooses, they would have a very reasonable case against you, should they decide to pursue a legal suit.

And tweeting that you have reported your critic to the police for stalking/harassment, when they have not done so, is also not a good idea.

Police! Police!

At best, you're probably just bluffing, in which case you look like a fool. At worst, if you aren't bluffing and really did file a police report, you may find that you are running afoul of certain laws about filing false police reports (see also 18 USC 1001 - h/t to Squillo).

To Recap

Hopefully you have a good idea of what not to do on the internet. Violating these four simple rules will almost certainly guarantee that you will become a laughing stock, having your shame spread all over, despite your efforts to bury the whole sordid mess. Remember:

#1 - Think before you post. (i.e., know at least a little about the subject)
#2 - Don't go Orwell. (i.e., don't try to make your own or others' comments disappear)
#3 - Don't deny you said what you said.
#4 - Don't libel your critics.

If you follow these rules, you should be able to avoid a great deal of headache, ridicule and embarrassment later.

This has been a public service announcement from Harpocrates Speaks.

The Path of Autism Causation Research

2011-12-08T07:00:00.017-05:00

A post over at Respectful Insolence inspired me. It gave me an idea for a post that can only be expressed in pictures. So, here you go:

Yeah, I know the style is derivative of xkcd and is a sad, sad imitation, but it's the best I could do with limited time, resources and skill. To see how it's really done, go to xkcd.

Like Water for Lockjaw

2011-12-02T15:11:00.000-05:00

The last Quacktion Figure™ gives me a good excuse to talk about a news item that popped up in my inbox the other day. Well, not so much a news item as someone's notion of a "brilliant" treatment for tetanus. You see, I have some alerts set up looking for vaccine preventable diseases. I take a quick glance at most of the stories and either do a quick tweet or simply archive it for background material for possible future posts. Every now and then, however, there will be something that catches my eye. Some combination of words in the headline or brief blurb snags my attention.

That's what happened with one such alert notification on tetanus. While perusing my inbox, what to my wandering eyes should appear but a story titled "Homeopathic Ledum for Tetanus".

Uh oh.

I haven't exactly been very coy with my thoughts on homeopathy. A lot of commercial products aren't even homeopathic, and when that happens, the consequences can be potentially deadly. I really have a problem when it comes to using homeopathy on kids; it is, in my opinion, grossly unethical. Since homeopathy is basically nothing but water and sugar pills, using them to treat anything more serious than a self-limiting or subjective condition is not simply careless, but willfully reckless. That's why I had something of a sinking feeling when I saw that e-mail.

Before I get into a discussion on the article itself, a little translation is in order. Homeopaths have this frankly bizarre need to invent new science-y sounding names for things or use their Latin, rather than common, names. It makes them sound smart and means the ~~mark~~ patient has little clue what the substance actually is. For example, "arnica" is arsenic.

So what the heck is "ledum"?

Photo by: Sten Porse

The article discusses the use of Ledum palustre. This is a variety of rhododendron, also known as Labrador tea or wild/marsh rosemary. In North America, it grows in northern latitudes, preferring arctic and subarctic climates. In small amounts, it can serve to season your food, but in large doses, it can cause some undesirable side effects, like stomach or intestinal irritation, kidney damage, seizures, increased menstrual flow or even abortions.

The author of the homeopathy article, Josephine, is certainly a fan of magic water. She also seems to be of the belief that homeopathy is a valid substitution for vaccination, though she doesn't seem like she's completely against vaccines (at least not yet). That belief, that homeopathy is just as good as (if not better than) vaccination is a rather dangerous one.

You see tetanus (PDF) is not what one would call a happy, fun time. The bacterium that causes the disease is found just about everywhere in the world. It lives in dirt and feces, doesn't care much for oxygen-rich environments and wreaks havoc on one's nervous system using its lovely toxin, tetanospasmin. Even with treatment, it has a death rate of about 11%. It causes your muscles to spasm, potentially breaking bones and halting your ability to breathe. One of the most important muscles in your body, your heart, is not immune, either; the toxin can cause irregular rhythms. And then there's the lovely secondary infections that take advantage of tetanus' work, causing pneumonia or even sepsis.

What does this ledum stuff have to do with tetanus?

According to homeopaths, if you give large doses of a substance to a healthy individual and it causes certain symptoms, then when you give highly diluted preparations of the same substance to people suffering those symptoms, the preparation will lessen or even cure the symptoms. Using this reasoning, since ledum in large enough doses causes muscle spasms, stiffness and joint pain, then it must be good for treating tetanus!

There's just one problem. It doesn't. At least, I couldn't find a single study on PubMed looking at ledum palustre use for the treatment of tetanus. No studies looking at whether or not it had any effect. No studies even showing whether or not the substance is safe! I also searched some of the PLoS journals. Nada. Medscape? No luck. There wasn't even any information available from the National Center for Complementary and Alternative Medicine.

You see, the way tetanus works, there is only one way to treat an infection. First, you need to kill any bacteria that are circulating in the body. Since they are the critters that produce the tetanospasmin, they'll just keep pumping it out into your body until they're dead. Unfortunately, the antibiotics used to kill the bacteria will have no effect at all on the toxins already circulating through your system. That requires the administration of tetanus immune globulin, which neutralizes any freely circulating tetanospasmin. But we're still not done. Since TIG can only neutralize free toxins, any of the toxin that has already bonded to your nerves will continue to cause problems. To prevent serious injuries or death that might result from the muscle spasms these toxins cause, other drugs may be used to sedate you, relaxing your muscles and stopping the convulsions until your body is able to finish off the last of the toxins on its own.

Because treating tetanus is so involved, costly and time-dependent, and because it doesn't necessarily lead to full recovery, I can understand the desire to find something that is cheaper and likely will have fewer side effects. A magic bullet, as it were, can be very appealing. Unfortunately for people like Josephine, trying to treat an actual (as opposed to suspected) tetanus infection with homeopathy rather than real treatment gives you nothing but a 1 in 4 chance of death.

Josephine ends her article by stating:

Ledum is brilliant homeopathic remedy for Tetanus, but as always, please get homeopathic advise first.

Frankly, Josephine, that is dangerous and irresponsible advice.

My advice, talk to a real doctor. Stay up to date on your tetanus shots and seek real medical help if you get infected.

Quacktion Figure™ Friday: Homeopath

2011-12-02T00:01:00.063-05:00

Do you feel constrained by physics, chemistry and biology? Does the idea of selling Tic Tacs at a 5,000% markup appeal to you? Want to be part of a billion-dollar-a-year industry that rivals Big Pharma^TM? Would you like to bang cups of water on a Bible to magically turn them into healing tonics?

Well, now you can. Harpocrates Speaks brings you Homeopath!

Homeopath

That's right. With Homeopath, you can kiss Avogadro's Limit goodbye! Got the flu? Not a problem for Homeopath. Just eviscerate a duck, drop a bit of its liver in some water, then dilute until only H₂O remains. Use the lever on back for magic succussing action to "potentize" your nostrum, then drip it on a sugar pill. Fend off critics with claims that water has memory, but somehow forgets all the poop it's touched. Sure your remedies don't do jack, but who can resist such a "sweet" personality?

Homeopath stands 5¾" tall and comes with:

Eviscerated duck
Flask
Dropper
Scalpel

Table not included. Legal thuggery expansion pack sold separately.

The Fine Print
Figure not actually for sale. Figure and text intended as a work of satire. Image copyright Todd W. and Lil Peck. Quacktion Figure™ is a trademark of Todd W. and Harpocrates Speaks.

Complete Quacktion Figure™ series

Opting Out of Vaccinations

2011-11-30T12:32:00.002-05:00

A reader forwarded a news story to me about the recent study finding that more and more parents are opting out of giving their children the recommended vaccinations. I'll try to talk a little more about that in a separate post, when I get some time to do some more writing. In the meantime, here's the video:

The only quibble I really have is that the quote from Jennifer Margulis went unaddressed:

Many of the vaccines are unnecessary and public health officials don't honestly know what the effect of giving so many vaccines to such small children really are...

Most, if not all, of the vaccines are necessary for public health and prevention of disease. And the effects of the vaccine schedule can be seen from the long history of safe use.

Other than that, it's a nice, short summary of some of the concerns about dropping immunization rates.

Paying to Volunteer

2011-11-30T06:51:00.003-05:00

This past weekend, while many were getting together with family and friends, sharing in feasts, watching TV and spending too much money on holiday shopping, a story erupted among skeptic circles. Like many such matters, it began with the actions of an apologist for what is, at best, questionable science and at worst rank quackery. An individual, Marc Stephens, put himself forth as representing one Dr. Stanislaw Burzynski. Mr. Stephens, you see, took it upon himself to defend the reputation of the good doctor, going so far as to rattle his saber and issue legal threats to Andy Lewis (aka Le Canard Noir) of Quackometer and teenage skeptic Rhys Morgan. They were to take down their less than complimentary writings about Dr. Burzynski or face a libel suit. We've seen this kind of thing before.

As most of you know, the routine generally goes something like this: person Q comes up with some rather extraordinary claim; a critical thinker closely examines the claims and offers some legitimate criticisms; Q, rather than addressing the criticisms, threatens to sue the critical thinker for libel; then, since most people don't want to deal with the headaches and expense of defending such a case, they'll probably back down. Basically, that's what happened here, except that instead of tucking their tails and slinking into quiet obscurity, Andy and Rhys politely requested that Mr. Stephens explain which specific statements he felt were libelous and the reasons why. Instead of taking the polite, ethical and standard approach of pointing out the particular offensive passages, Stephens continued to try to bully them into silence. This is not what one does if one wishes to avoid making a fool of oneself. His actions only served to fuel ridicule for him and the Burzynski Clinic he purported to represent in the matter. I'm not going to go into all of that any further. If interested, Liz Ditz has, as usual, a plethora of links to other blogs covering the story, as do Josephine Jones and Anarchic Teapot. For a discussion on the science of Burzynski's claims and a review of a ~~infomercial~~ documentary film about Burzynski, head over to Respectful Insolence for Orac's usual close scrutiny.

Instead, I want to talk about a question that arose regarding Burzynski's research. Namely, that he charges lots and lots of money to participate in his clinical trials. An individual seeking help from him will quickly find themselves racking up a bill in the tens or hundreds of thousands of dollars. Often, these will be people who have run out of options: they have been diagnosed with inoperable cancer or may have pursued conventional treatments to their limits. They are desperate and may be quite willing to spend the money required to grab at any hope they can. And I understand that. I don't blame them. If I were in a similar situation, I'm not certain what I would do, but that need for something, for some hope, would definitely be very, very strong.

But isn't that illegal?

How can he charge people who are volunteering to participate in a clinical trial? Isn't there some law against that?

Technically, it isn't necessarily against the law. There is a regulation (21 CFR 312.8) that allows researchers to charge study participants for the study drug in certain situations. For example, if I wanted to study some new use for Zantac and needed to buy the drug from the manufacturer, I could pass that cost along to the study participants. In the case of unapproved drugs, like Burzynski's "antineoplastons", then there are certain conditions which must be met.

First, the sponsor must:

(i) Provide evidence that the drug has a potential clinical benefit that, if demonstrated in the clinical investigations, would provide a significant advantage over available products in the diagnosis, treatment, mitigation, or prevention of a disease or condition;

Burzynski would need to show, through in vitro or animal studies, for example, or early phase I trials, that his antineoplastons have might be more effective or have fewer side effects (or both) compared to any alternative treatments that subjects would normally be able to receive. He would need to compare his drug to the "gold standard" used for a specific disease (e.g., glioblastoma).

But that's not enough to be allowed to charge for his drug. The sponsor must also:

(ii) Demonstrate that the data to be obtained from the clinical trial would be essential to establishing that the drug is effective or safe for the purpose of obtaining initial approval of a drug, or would support a significant change in the labeling of an approved drug (e.g., new indication, inclusion of comparative safety information);

The antineoplastons developed by Burzynski would need to be backed by some convincing explanation that the results of the clinical trial would support approval by the FDA. Assuming that point one, above, is met, this shouldn't be difficult to accomplish. In fact, the stronger the initial evidence suggesting a significant improvement over approved products, the easier this argument would be to make.

Assuming that the sponsor has some evidence suggesting their product will be better and that the clinical trial would lead to approval, there is still a third condition that must be met. They still must:

(iii) Demonstrate that the clinical trial could not be conducted without charging because the cost of the drug is extraordinary to the sponsor. The cost may be extraordinary due to manufacturing complexity, scarcity of a natural resource, the large quantity of drug needed (e.g., due to the size or duration of the trial), or some combination of these or other extraordinary circumstances (e.g., resources available to a sponsor).

Usually, sponsors bear the costs of conducting a study. They seek grants from nonprofit organizations, government agencies like the National Institutes of Health or even for-profit companies. In order to charge for the drug, the sponsor would have to face some seriously large expenses. Obtaining the drug would have to be so expensive that the normal avenues to fund a study would be insufficient to cover costs. In Burzynski's case, the antineoplastons, now synthetically developed, were originally obtained from urine. Not exactly a scarce resource, but the isolation of the amino acids might be a difficult and costly procedure. Then again, from what has been reported so far, subjects get a huge amount, pharmocologically speaking, of the study drug, up to around 7g (yes, grams) per kilogram.

So let us assume that Burzynski has the evidence (i), would be able to obtain data from the clinical trial leading to FDA approval (ii) and, after all other funding sources had been exhausted, would be unable to conduct the trial without charging for the drug (iii). What could he actually charge for?

I'll quote this section in its entirety (underlined emphasis added):

(d)Costs recoverable when charging for an investigational drug. (1) A sponsor may recover only the direct costs of making its investigational drug available.

(i) Direct costs are costs incurred by a sponsor that can be specifically and exclusively attributed to providing the drug for the investigational use for which FDA has authorized cost recovery. Direct costs include costs per unit to manufacture the drug (e.g., raw materials, labor, and nonreusable supplies and equipment used to manufacture the quantity of drug needed for the use for which charging is authorized) or costs to acquire the drug from another manufacturing source, and direct costs to ship and handle (e.g., store) the drug.

(ii) Indirect costs include costs incurred primarily to produce the drug for commercial sale (e.g., costs for facilities and equipment used to manufacture the supply of investigational drug, but that are primarily intended to produce large quantities of drug for eventual commercial sale) and research and development, administrative, labor, or other costs that would be incurred even if the clinical trial or treatment use for which charging is authorized did not occur.

So only the cost to make the drug or to acquire the drug from another manufacturer can be charged to subjects. Research and development costs, administrative costs of running the study, wages or salaries for study staff are all off limits; the subject cannot be charged for those. Likewise, any procedures which are not part of normal care for the disease and are used only for the purposes of the study generally cannot be charged to subjects (i.e., biopsies to confirm cancer diagnosis would be billable, blood draws for study-related measurements would not). The sponsor then needs to provide documentation justifying the costs to be recovered by charging subjects.

Once all of these requirements are satisfied and submitted to FDA, the sponsor cannot charge subjects until they receive written authorization from the agency. If the FDA feels that charging subjects interferes with clinical trial enrollment or smacks of commercial sale of the drug, they can revoke authorization.

Not knowing all of the details, I can't really offer a strong opinion on whether or not Burzynski is meeting these criteria. It seems, based on some of the things I've read, that he's charging for more than just the investigational drug and standard treatment-related costs. I'd also be very curious to see the approval from FDA allowing Burzynski to charge subjects, if such an approval actually even exists. I wouldn't be all that surprised if he hadn't actually received authorization or if he went a bit beyond the specific authorization he did receive. I'm fully willing, though, to be proven wrong.

It may be legal, but isn't it unethical?

I have to apologize. I've been a bit long-winded on the legalities. If you're still with me, here's the bit that people really want to know. Is the system broken if it allows subjects to be charged, when they are already taking on the risks of a drug which, by definition, has not yet been shown to be safe and effective for the condition under study? Isn't that wrong?

The case of Burzynski's trials, spanning several decades, gives us a good excuse to discuss this ethical question. The exorbitant prices he charges his subjects make it easy to cry foul. When we think about clinical trials and human subjects research, we think about how the whole point of the research is to figure out whether the drug is a) safe and b) actually does something that has a meaningful benefit for patients. Anyone volunteering for a drug study is necessarily taking a risk beyond what they would normally face. There may be as yet unknown side effects of the drug, some of which may be quite serious. The drug might be less effective than available alternatives (or even completely ineffective), leading to possible worsening of the patient's condition. When they are already facing such risks, it seems wrong and unfair to ask any more of them, like making them pay financially.

But, just like with the ethical dilemmas around paying study subjects, where payment may serve as an inducement to participate against their own best interests, charging subjects isn't necessarily unethical in and of itself. There may be situations where there really is justification to do so, where the study would not be able to be conducted without such measures. There may be a product which really could help future patients, not to mention the study subjects themselves. Although early studies may show some promise, we all know (or should know) that research dollars don't come easy. There are a lot of project out there, some worthy, others not quite so worthy, all vying for limited resources. Despite a researcher's best efforts and intentions, the cost of an investigational drug may simply be too great to move forward. In those situations, completely banning the practice of charging subjects for the study drug may delay development of newer, better drugs or even prevent their development altogether.

The ethical questions here would be a lot nicer if everything were black and white, but life is seldom so simple as that. As with everything, there is nuance; a multitude of factors rise up for consideration. There needs to be room to accommodate those subtleties. While no regulation is folly, an iron fisted prohibition is likewise foolhardy.

Getting back to Burzynski specifically, even if he were to justify to the FDA the need to charge subjects, he would still need IRB approval to do so. If the IRB thinks that billing subjects for study-related procedures or the drug itself is unethical, then they may require that subjects will not be billed. FDA authorization, however, would act as a strong influence to favorably sway the IRB. That said, any IRB worth its salt (about which there is some question regarding the Burzynski Research Institute's IRB) would definitely require that the consent forms for the trials clearly state which specific charges would be billed to the subject, including the amount of the charges, as well as a statement that insurance companies might not pay for those costs. If you are reading this and are considering enrolling in one of Burzynski's trials, make sure to very carefully read the consent forms and keep a copy for yourself. In fact, I would very much like to see a copy of the consent form from any past or current subjects (feel free to redact signatures). You can e-mail a copy to me by clicking this link.

The brouhaha around Burzynski and Stephens (why do I see an ogre in sweater and skirt with a club in one hand and a pom-pom in the other?) has brought the doctor quite a bit of attention and raised ethical questions to consider. It will be very interesting to watch how this all plays out. And if anyone happens to find a copy of the FDA authorizations (separate ones for each clinical trial, of which there are quite a few, it seems) for Burzynski to charge subjects, I'd consider it a kindness to get a glimpse.

Addendum: Almost forgot to mention something. After all the stuff I discussed above, I want to make one thing clear: charging subjects to participate in a study is not a common thing. Most of the time, subjects remain financially neutral or even get paid to participate in a study. If there are any charges, they are typically only in treatment studies and involve standard-of-care procedures, not the investigational aspects of the study.

Update: Karl Withakay had a very insightful comment over at NeuroLogica. If Burzynski is charging subjects to be in his study, then that means his studies are not randomized, controlled trials, which brings into question the validity of any results. You can't blind people to the treatment they're getting if they're paying for the study drug. If he is using randomization and controls, and thus charging all subjects for the investigational drug whether they're getting the study drug or not, then he's violating FDA regulations, employing illegal practices, since he cannot charge a subject for something they are not receiving.

May As Well Try to Stop a Storm...

2011-11-28T13:05:00.001-05:00

Clouds gather on the horizon. Thunder, like deep, rolling laughter, rumbles forth. A storm is gathering. Watching the approach from a vast, flat plain, a lone figure stands, clad all in maille and wearing the livery of his liege lord, shouting defiance to the heavens while brandishing a long metal pole. Marcus had always envisioned himself a great warrior, yet his simpleness of mind was apparent as he stood on that plain, watching the storm draw nearer and nearer.

Behind him rose the small, yet ornately decorated manor house of his lord, Stanis, whose wealth was accumulated through false promises to those desperate enough to turn to him for succor. The manor was surrounded by open land sloping gently down to the building. Its moat was filled with the dreams and hopes of the sick who sought relief at its doors.

Lightning flashed, arcing through the air between cloud and servant, drawn to the idiotic pomp enshrouding Marcus. Bolt after bolt zigged and zagged to the metal man, and every one then being drawn to the manor house and the lord watching from its lone turret. The more Marcus shook his fist impotently at the sky, the more frequent and powerful grew the display of light. He would as soon try to silence a speaker of truth as stop the storm about to plunge him, and his Stanis, under a flood.
_____________________________________________________________
To put this all in context, check out the posts linked by Liz Ditz, Josephine Jones and Anarchic Teapot. For how the storm started, check out Rhys Morgan and Le Canard Noir. And if you like this little story or think that the tin man needs some more well-directed shocks, please consider sharing this on Twitter.

Varicella Vaccination Among Older Kids Protects Infants

2011-11-28T12:32:00.001-05:00

Turning on the news this morning, I was greeted with a story that caught my ear. Published online, ahead of print, a new study in the journal Pediatrics, "Varicella in Infants After Implementation of the US Varicella Vaccination Program", looked at the incidence of varicella (chickenpox) among infants under 12 months of age.

The varicella vaccine was approved in 1995 and is recommended for all children aged 12 months to 12 years. It is a "live" virus vaccine, meaning that the vaccine uses intact, though weakened, virus particles that grant immunity without causing full-blown disease. Vaccines of this sort are generally more effective than "killed" virus vaccines, which only use part of the virus. Because of the approved age range for the vaccine, it does not provide direct protection to infants under 12 months of age, but it can provide protection through herd immunity.

So what did the researchers find?

In the observational study, the authors looked at chickenpox incidence among infants under 12 months of age from 1995 to 2008. The population was broken up into 0-5 months and 6-11 months. They found that incidence among the total infant population fell 89.7% over the period examined. They also noted that complications and severity of disease was lower in the younger age group vs. the older group. The authors speculate that this may have been due to maternal antibodies (which generally provide some protection to infants for about 6 months).

The results of this study add to an examination by the CDC of the impact of the varicella vaccine from 2003. The CDC looked at all cases, finding that while incidence remained steady prior to approval of the vaccine, the rate of new cases declined beginning in 1999. A more detailed look at the disease and vaccine can be found in the the CDC's Pink Book chapter on varicella (PDF). This resource also notes that the vaccine is 70%-90% effective, and even in cases where it fails to prevent infection, it is about 90%-100% effective in ensuring a milder course of illness.

Since chickenpox is only known to infect humans, this study shows promise that we may, one day, eliminate the virus from the planet, much like we have with rinderpest among cattle, smallpox among humans and are on the verge of doing with polio. We have more evidence that vaccination protects far more people in the community than just the person getting the vaccine. As the study authors note:

The varicella vaccination program has resulted in substantial indirect benefits for infants, who are not eligible for vaccination. Presence of maternal varicella-zoster virus antibodies might explain attenuated disease in very young infants likely born to mothers with history of varicella. Although varicella disease incidence has declined, exposure to varicella-zoster virus continues to occur. Improving varicella vaccination coverage in all age groups will further reduce the risk of varicella exposure and protect those not eligible for varicella vaccination.

To those who oppose vaccination against chickenpox, claiming it is a "mild" disease or a "right of passage", consider this. We have a tool that could, given enough time and use, render itself useless. This tool could eliminate, completely, a disease that before its use cause 11,000 hospitalizations and 100 deaths per year in the U.S. Even mild courses of illness mean a week of lost school time. While children may enjoy having an excuse not to go to school, making up the missed homework is no fun. Furthermore, there is a cost for parents who need to miss work to care for their itchy young'n. That may be as simple as using a vacation day that could have otherwise been used for more important or fun family time; or, it may mean days of lost wages, which some cannot afford to lose. The more people use the tool, the sooner we can stop using it altogether. The more you fight against its use, the longer it will be used.

Think on that.

Quacktion Figure™ Friday: Faith Healer

2011-11-25T00:01:00.042-05:00

Do you dream of working only one day a week? Have you ever thought how nice it would be to draw crowds of thousands to pack a stadium, all to see you? Ever thought how easy it would be to pay for that private jet, California mansion and the latest Porsche if only you were willing to take advantage of the religious faithful?

Well, now you can. Harpocrates Speaks brings you Faith Healer!

Faith Healer

That's right. With Faith Healer, you can pack 'em into the nearest stadium and convince them you can actually speak to God. With the easily hidden radio ear piece, your wife can feed you information on attendees gleaned as they entered, wowing them with your miraculous insights into their lives. Call the believers up on stage and use the lever in back for Miracle Faith Healing action! To drain the pockets of those who couldn't attend your stage act, just sell them your Miracle Money Incense. Your promises to pray for them when they send you back the ashes and $50 will end their money woes. After all, if they have no money, they have nothing to worry about!

Faith Healer stands 5¾" tall and comes with:

Radio ear piece
Miracle Money incense
Wad o' cash

Wheelchair for "Make 'Em Walk Again" scam sold separately.

The Fine Print
Figure not actually for sale. Figure and text intended as a work of satire. Image copyright Todd W. and Lil Peck. Quacktion Figure™ is a trademark of Todd W. and Harpocrates Speaks.

Complete Quacktion Figure™ series

Report on MN Measles Outbreak from IDSA

2011-11-23T07:00:00.002-05:00

Several weeks ago, from October 20-23, Boston, MA played host to the 49th Annual Meeting of the Infectious Disease Society of America (IDSA). This conference gives physicians, scientists and other health care professionals an opportunity to continue learning about the pathophysiology, diagnosis, treatment and prevention of infectious diseases, as well as to connect with colleagues from around the country. The conference presents speaker sessions, poster presentations, exhibits and networking opportunities.

One of the poster presentations at IDSA covered the measles outbreak in Minnesota earlier this year. Presented by several members of the Minnesota Department of Health (lead author, Pamela Gahr, MPH, Cynthia Kenyon, MPH, David Boxrud, MS, Karen White, MPH and Ruth Lynfield, MD) and Hennepin County Human Services and Public Health (Erica Bagstad, MS, MPH), the poster offered a closer look into how and why measles was able to spread, as well as insight into some of the difficulties involved in investigating and controlling the outbreak.

The poster has a lot of information, including a timeline of the outbreak and case discovery; analysis of vaccination status, clinical characteristics and lab confirmation of measles cases, broken down by hospitalized and non-hospitalized individuals; comparison of MMR and varicella vaccination rates for 2-year old children born in Minnesota of Somali and non-Somali descent; interventions used; and a discussion of the course of the outbreak.

One of the things that first jumped out at me was the timeline.

Click to Enlarge

The index case, a 2-year old child who contracted measles during a family trip to Kenya, first developed a rash on February 25. But this was not the first case identified in the outbreak. Nor was it the second or third case. In fact, it was the sixth case identified. Tracing the path of transmission from this child to four other children, and from two of those children to five other children and so on was fascinating. The spread included household contacts of various individuals, childcare centers, emergency departments and two homeless shelters.

The last setting had a particular impact on limiting the spread of the outbreak. Outbreak control measures, such as isolation and quarantine, would be very difficult to implement in a homeless shelter, with a large number of people coming and going every day. Although not discussed in the poster, these individuals may have had poorer overall health due to an inadequate diet and lack of regular, quality health care, not to mention the stresses involved with homelessness. These factors would have combined to make the course of illness and complications more likely to be severe. This is borne out by the fact that over half of cases (14 of 21) were hospitalized. As the authors report:

14 (61%) were hospitalized (mean 4 days; range 2-7 days). Of the hospitalized cases, 12 (86%) had dehydration, 9 (64%) diarrhea, 8 (57%) vomiting, 7 (50%) otitis, 4 (29%) croup, 2 (14%) pneumonia, 2 (14%) bronchiolitis, and 1 (7%) thrombocytopenia. 3 (21%) had reactive airway disease or asthma (Table 1).

Click to Enlarge

I'm curious to know how many of these complications occurred in the same individuals. For example, did most of the dehydration occur in cases of diarrhea and/or vomiting? Was croup or bronchiolitis connected to pneumonia? Thankfully, though, these individuals did get proper medical care to prevent more serious complications, since some of the reasons for hospitalization could very well have had much worse outcomes, whether it is serious bleeding due to thrombocytopenia or even death by dehydration, given the health care and living status of many of the individuals involved.

Many in the anti-vaccine community may downplay these complications as being minor, and that hospitalization was unnecessary. For instance, some might say that diarrhea is nothing serious, yet among infants, and especially among those with poor living conditions, it can be quite serious, potentially fatal. It is important to remember that these hospitalizations were of a severity that simple management was no longer sufficient to keep the patients healthy; more specialized care was required. The sad thing is that these outcomes could have been minimized or prevented altogether through immunization.

Click to Enlarge

Which brings us to a look at the vaccination rates for MMR among those of Somali descent versus those of non-Somali descent. Looking at two-year olds born in Minnesota among these two populations, the average vaccination rates for Somalis were actually higher than for non-Somalis from 2004 to 2007. But something very curious occurred. There was a slight decrease in 2006, with rates among the Somali population becoming about equal with that of non-Somali by 2007, followed by a very steep decline in MMR uptake, going from about 85% in 2007 to just 60% in 2008 and only 57% in 2009. Meanwhile, uptake rates among non-Somalis increased over the same period, approaching 90% for at least one dose of MMR in 2009. Why this decrease among Somalis? What happened during the period from 2004-2007 that may have persuaded Somali parents to stop vaccinating their children with the MMR?

My suspicion was that there was some manner of anti-vaccine activism around that time. I looked for mentions of Generation Rescue, but it looks like they were only active after the decline had started, though comments by J.B. Handley certainly did nothing to help stop the drop in immunization rates. The annual Autism One conference had been going on, but that was in Chicago, and it seemed unlikely that many of the parents would have been able to make the trip. My Google-fu failed me. Fortunately, a reader came to my rescue. It seems that David Kirby happened to be touring his book Evidence of Harm in 2005, making a stop in Minneapolis on May 25 of that year. Although his focus was on the erroneous notion that thimerosal caused autism, his message was one that sowed the seed of fear of vaccines.

Liz Ditz suggested that formal meetings or gatherings would probably be hard to find; the anti-vaccine message would likely have spread by word of mouth or through invite-only discussion boards. Following this line of thought, I contacted the MN Department of Health once more to see if they knew of any causes for the drop in vaccination rates. Word of mouth, it appears, certainly played a major role, as did DAN! physicians:

Based on conversations MDH has had with some Somali community members we have found that by the time this issue became public and to the Department of Health’s awareness in 2008, the community was already mobilized. Many of the parents had been attending national DAN autism conferences for several years prior to this time. Word of mouth is a powerful source of communication within the community and as more families had children diagnosed with autism, the community started talking about what to do to prevent this threat. The only information they had prior to a community meeting with them November 2008 was that MMR caused autism. Interspersed with that is that vaccines cause autism. When a parent who had a child with autism tells another parent don’t let your child get the MMR, they listen and many have been refusing MMR since then.

So, in the face of what can be a very devastating disorder for their children, the parents were taken in by pseudo-medicine and propaganda. They were lied to by physicians who had no evidence for their claims. Not only were they given false hope that they could avoid autism by avoiding the MMR, their children were left unprotected, and their lives were put at needless risk.

One of the only questions remaining to me about this outbreak is the cost. The number crunching remains to be done to find out just how much these 21 cases cost the taxpayers of Minnesota. And what was the cost to the parents, both in terms of providing care for their children and missed wages?

The full poster is not currently available online. I do have a copy of the PDF, portions of which are reproduced above (Blogger doesn't allow uploading of PDFs). The good folks at the Minnesota Department of Health were kind enough to send it to me and allow me to share it. If interested in seeing the full poster, send me an e-mail request. Thanks also to Liz Ditz, who helped with some research.
_________________________________
Related Posts:
Third Case Identified in Latest Measles Outbreak in Minnesota
New Measles Cases in Minnesota
Minnesota Measles Outbreak - A Recap
Acute Thrombocytopenic Purpura, the MMR and Natural Infection
"Soft" Hospitalizations in Minnesota Measles Outbreak?
Minnesota Measles Outbreak by the Numbers: A Timeline
Measles Outbreak in New South Wales, Australia
Climbing Numbers in Minnesota Measles Outbreak
More Cases of Measles in Minnesota, 3 of 4 Hospitalized
Minnesota Infant Contracts Measles - Why Immunization Is Important
Measles Outbreak in Boston

Quacktion Figure™ Friday: Chiropractor

2011-11-18T00:01:00.008-05:00

Have you ever wanted to heal people, but found the complexities of medicine too much to handle? Thought how nice it would be to have a single cause of all diseases? Do you think of how nice it would be to fleece people using a made-up device that doesn't work as claimed, but find yourself bound by your own ethics and a desire to do no harm?

Well, fret no more. Harpocrates Speaks brings you Chiropractor!

Chiropractor

That's right. With Chiropractor, you can dream up your own theory of disease based on non-existent spinal displacements and pinched nerves. No matter how unconnected with the musculoskeletal system, you can claim to cure anything with a simple shove of the vertebrae using your Chiropractic Adjusting Tool (C.A.T.). Kid have an earache? No problem! Don't worry that no auditory nerves pass through the spine; just a quick twist of the neck is all it takes. Diagnose all manner of diseases using your patented e-meter. Measure the non-existent "innate intelligence" and interpret the readings to mean anything you want! And with the flexible model of the human spine, you can demonstrate how misalignments of the vertebrae look so scary to remind them that regular treatments are needed. Keep 'em coming "back" for more!

Chiropractor stands 5¾" tall and comes with:

Chiropractic Adjusting Tool (C.A.T.)
Flexible model of the spine
E-meter

Malpractice insurance to cover adjustment-induced stroke sold separately.

The Fine Print
Figure not actually for sale. Figure and text intended as a work of satire. Image copyright Todd W. and Lil Peck. Quacktion Figure™ is a trademark of Todd W. and Harpocrates Speaks.

Complete Quacktion Figure™ series

National Vaccine Misinformation Center Calls Out AAP for Using Free Speech to Promote Reality

2011-11-16T13:09:00.001-05:00

Recently, the American Academy of Protecting Kids' Health (AAP), a physician group whose goal is to promote practices and education to keep children healthy, wrote a letter of protest to Melting Airlines' decision to run a misinformative ad about influenza. The ad, paid for by the National Vaccine Misinformation Center (NVMC), discusses what on the surface appears to be good advice for avoiding the flu. The AAP disagrees with the ad because rather than directing people to a web site with accurate and truly informative information, it drives people to the NVMC web site, which is a cesspool of rank claptrap.

Barbie Moe Flusher, founder and president of the NVMC, has taken umbrage at the characterization of her organization as one that:

opposes the nation's recommended childhood immunization schedule and promotes the unscientific practice of delaying or skipping vaccines altogether

In a press release, Flusher states, "Just because we bend the truth, the AAP has used their free speech rights to politely reprimand Delta for simply showing a video that offers a polished, glossy cover to entice people to visit our site during flu season, including what any rational physician would recommend, like talking with doctors about getting a flu shot, which I think is totally crap, but that's beside the point. Exercising free speech and consumer activism to silence dangerous misinformation like ours should not be tolerated in this or any society that cherishes deluded individuals and ne'erdowells preying on the uninformed."

The AAP's letter to Melting states that the influenza vaccine is one of the best ways to prevent getting the flu. Flusher feels that this is misleading, because the AAP does not state that the vaccine is not 100% perfect and shiny. According to Flusher, if something is not perfect, then it isn't worth it. "Why would anyone in their right mind opt for only partial protection? If you can't have complete protection, then obviously you shouldn't have any! These elitist physicians with their stethoscopes and desire to keep people healthy would have you think some protection is better than none, but that's a load of s***."

Although people who actually research the topics of immunology, vaccines and infectious diseases may characterize the NVMC as an anti-vaccine organization, Flusher disagrees.

"NVMC is a non-profit charity led by emotional and misguided health care consumers. We are not doctors, but we do feel completely comfortable telling people how or when to vaccinate and sometimes even advise people not to vaccinate," said NVMC's Flusher. "We try to not overtly state that people shouldn't vaccinate, because that would just give away our hand, know what I mean? Instead, we tell people about how vaccines are filled with horrible poisons and dream up stories of injuries with no basis in fact. Then we let them decide what they want to do. We have a long public record of promoting poorly informed, voluntary health care mistake-making."

An example of the NVMC's message can be found in their article "Vaccines Will Kill Your Baby: What You Should Ask When Deciding Whether or Not to Vaccinate". After describing in excruciating detail how vaccines will, by some unknown and undefined mechanism never before seen by science, cause your child's neurons to spontaneously combust, the article concludes with, "But, y'know, if that's what you want for your kid, go ahead. It's a free country. Who am I to tell you what to do, your mother?"

To Flusher, the AAP's actions constitute censorship, despite the fact that they are not shutting down her web site, gagging her or burning her books. She calls it legal intimidation, adding, "And so help me God I will sue every last one of those m***********g a******s if they keep telling people not to let me run my misinformation!"

The National Vaccine Misinformation Center is a 501C3 charity founded in 1982 by parents of children they thought at the time were injured by vaccines and is dedicated to advancing vaccine preventable injuries and deaths through public miseducation and protecting the misinformed consent of consumers.

The Sequelae of Pox

2011-11-15T09:42:00.000-05:00

A couple weekends ago, something of a firestorm erupted among skeptical bloggers. Namely, the news about parents sending pox-laden lollipops through the mail. It was covered by Mike the Mad Biologist, Emily Willingham, Reuben, Tara Smith, Orac and Phil Plait. Largely, the various bloggers, myself included, condemned the parents in the original story because they were knowingly sending infectious material in the mail.

Some folks in the comments of the various articles made the observation that every day, people lick envelopes, handle packages in perhaps less than sterile conditions and so, perhaps unwittingly, leave unintended presents for the recipients, not to mention the delivery personnel. How is that any different from what these parents have done?

First off, I will readily admit that what the parents were doing probably would not lead to anyone contracting chicken pox. Since the virus does not remain viable for very long at all in the environment, it would most likely be rendered harmless given the amount of time it takes the package to be mailed. Even if the pox package managed to reach its target quickly, fomites like lollipops and spit-soaked rags also are unlikely to cause an infection, as the virus is primarily spread via the respiratory system. The oral route is a bit rough on the bug, and it would likely be destroyed before it could actually cause an infection.

That caveat aside, there is still the issue of other viruses and bacteria that may have hitched a ride on the fomites. Other diseases, like Hepatitis A (PDF), have a certain predilection for getting into you via your mouth. In the case of Hep A, making matters worse is that under the age of 6 years, those infected with the virus are likely to show no symptoms at all. That means that some of these parents may not realize their child even has the disease at all, and so they do not take any manner of precautions to reduce the chances of sending anything other than the varicella virus.

But what about licking envelopes? Doesn't that carry the same risk?

Well, for the recipient, not really. It's unlikely that they are in the habit of sucking on envelopes. There may be some small, minute chance, of course, that touching your nose or mouth after handling the mail could introduce some pathogen into your body. However, with the package contents, the whole point is to suck on the lolli, rag or toy. The recipients are intentionally increasing their own odds (well, the odds of their child, since they're making the decision for someone other than themselves) getting sick from something in the package.

As for the mail carriers, it is a little more difficult to judge the danger. Although they are unlikely to come in contact with the contents of the package, there is a risk that the packaging will be damaged in some manner, thus exposing the carrier to whatever lies inside. That risk is generally not there with everyday mail; I don't know about you, but I don't think most people are in the habit of sending used suckers or damp rags in the mail. True, as with the recipients, there is some small risk, regardless of package contents, that there may be some sort of surface contamination that may cause an infection if the carrier touches their mouth or, something they are at a bit higher risk for, gets a paper cut.

So yes. Admittedly there is very likely the unwitting transfer of infectious agents on envelopes and boxes mailed around the world every day. Where the recent story differs from the every day handling of mail, though, is in intent. The parents know that they are putting infectious material in the mail. They intend that some other person will become infected with the disease they are sending. Furthermore, as evidence by posts on the Facebook group that started this whole brouhaha, they also know that it is against the law to do what they are doing, going so far as to recommend ways to skirt the law (e.g., don't put anything on the label or outside of the package indicating that there is infectious material inside).

When you get down to it, that element, intent, is what separates what people do each day from the criminal activities of this group of parents. In our every day lives, we take reasonable precautions to avoid transmitting diseases. One of those precautions is to avoid knowingly sending contaminated and infectious materials in the mail.

Quacktion Figure™ Friday: Chelation Therapist

2011-11-11T00:01:00.033-05:00

Do you have a child with autism? Know someone with cancer? Do you wish there were some magic bullet to use instead of costly behavioral therapy or intense regimens of surgery, radiation and chemotherapy? Would you like to use experimental treatments outside a clinical trial setting? Are pesky regulations keeping you from doing any of this?

Well, now you can change all that. Harpocrates Speaks brings you Chelation Therapist!

Chelation Therapist

That's right. With Chelation Therapist, you can develop your own evidence-free therapies that are one-size fits all! Want to boost the immune system? Just inject a little urine. Autism? Use your very own experimental chelation cream! Breast cancer? Chelate! Prostate cancer? Chelate? Lung cancer? Chelate! Chelate! Chelate! And should the local medical board look askance at your maverick ways, just use your political influence to change the laws and hamstring those "rabid dogs"! Easy as buttering up some bread.

Chelation Therapist stands 5¾" tall and comes with:

Urine-filled syringe
Experimental chelation cream

Pocket legislator sold separately.

The Fine Print
Figure not actually for sale. Figure and text intended as a work of satire. Image copyright Todd W. and Lil Peck. Quacktion Figure™ is a trademark of Todd W. and Harpocrates Speaks.

Complete Quacktion Figure™ series

Pox by Post

2011-11-04T19:30:00.002-04:00

Something came to light today that made me despair for the human race. I first read it at Mike the Mad Biologist's blog. It was also covered by Emily over at The Biology Files, where Emily took a look at just who the people were that were involved. Reuben wrote about it at The Poxes Blog and Tara discussed it at Aetiology.

What could have gotten the medical and skeptical blogosphere in such an uproar? This story.

You may have heard of pox parties. These little bits of idiocy involve parents bringing their children who have not had the chickenpox over to the house of another family whose child is currently sick with chickenpox. The intent is to purposefully infect their little darlings with a disease that can become quite serious, with hospitalization rates that could be as high as 2-3 per 1,000 cases among healthy children. The reason they do this is because they have an irrational distrust of vaccines and the mistaken belief that natural infection is actually better, because, y'know, actually getting the disease and risking all the very real complications is better than a shot that makes you immune without getting ill or suffering the much more common secondary nastiness from the wild virus.

Well, the recklessness of people like this has gone up a notch. You see, thanks to vaccines, the rate of infection with the varicella virus has declined dramatically, so that it is much more difficult today to find a child with the chickenpox. This makes pox parties a bit harder to find. These paragons of wisdom (that's sarcasm, in case you missed it) have decided to mail the virus to each other. That's right. They're sending lollipops, spit, toys and other contaminated crap to each other. What could possibly go wrong?

Well, for starters, they're breaking the law. Varicella is classified in biosafety risk group 2, meaning the those working with it must be trained in how to handle it and follow certain protocols to prevent inadvertently letting it out into the environment. In order to ship material like this, the sender must be trained in proper packaging and handling of the material, and trained carriers with a permit can transport the package. Clearly, though, the law does not matter to these twits, since in response to someone pointing out that it was a Federal offense, one woman answered:

"Tuck it inside a zip lock baggy and then put the baggy in the envelope :) Don't put anything identifying it as pox."

But it isn't just the law about which they are clueless. They have absolutely no thought to the risk involved. These items may be carrying more than just the varicella virus. Hepatitis A and B viruses, meningococcal bacteria and other baddies may also be lurking on that tempting lolli they just received. They are putting their children at significant risk of very serious injury or, yes, even death, all because they think they know better than people who have spent their lives studying biology, immunology and infectious diseases.

But it isn't just their kids that they are putting at risk. They are also jeopardizing the mail carrier who picks up the package, the postal workers sorting things to the right trucks, the drivers that transport the packages, the mail carriers at the receiving end--in short, everyone who handles it along the way. Should any of their ziplock baggies fail, so much for containing the contagion. And what about the external packaging? I'm guessing these people are not practicing the best of sterile handling techniques. They have no clue whether the people who handle their mail may be immune compromised. If they have HIV, are on immunosuppressants due to receiving a transplant or have suppressed immune systems due to age or cancer treatment, they are at very high risk of serious complications from being infected. Even worse, these nitwits aren't content to leave it at just chickenpox; there are some who are even looking to get measles, mumps or rubella samples by mail.

The sheer arrogant ignorance of these people enrages me, to the point that I'm going to do something that I try to avoid, at least on the blog. I try to keep my language clean, but these assholes have no clue what the hell they're doing and the kind of shitstorm they could potentially unleash. For anyone that thinks that this is a good idea, I have just one question for you:

[This bit redacted, now that I've had a little bit of time to cool down. Just imagine a cursing, slug-related insult here, with apologies to slugs.]

I seriously hope that the police and FBI are investigating this issue and will bring the full force of law to bear on these sad wastes of human intellect. And who do we have to thank for thinking like this? People like Jenny McCarthy, Barbara Loe Fisher and the NVIC, Generation Rescue and Age of Autism and all the other anti-vaccine activists out there who advocate for natural infection and preach fear of vaccines. Any harm that comes of this idiocy can be laid at your feet.

Quacktion Figure™ Friday: Ayurvedic Guru

2011-11-04T00:01:00.007-04:00

Are you a medical doctor, tired of the drudgeries of trying to actually heal people? Have you ever thought, "Wouldn't it be nice if I could just make people think they were feeling better without doing all that messy real medicine"? Does the idea of raking in the dough and building a mass media presence by spewing mindless pablum and misusing terms like "quantum" appeal to you?

Well, now you can do all that and more. Harpocrates Speaks brings you Ayurvedic Guru!

Ayurvedic Guru

That's right. With Ayurvedic Guru, you can tell people to take herbs instead of real medicine. Your messages of love and peace will make people feel better, even while their conditions worsen. Worried about pesky questions from skeptics? Just wow them with your keen grasp of quantum mechanics. Present your very own Schroedinger's cat to prove the truth of your quantum woo. Sure, you might not convince people that know better, but your adoring fans will lap it all up!

Ayurvedic Guru stands 5¾" tall and comes with:

Sprig of Herbs
Simultaneously alive and dead cat

Miniature library of fanciful books, CDs and videos sold separately.

The Fine Print
Figure not actually for sale. Figure and text intended as a work of satire. Image copyright Todd W. and Lil Peck. Quacktion Figure™ is a trademark of Todd W. and Harpocrates Speaks.

Complete Quacktion Figure™ series

A Little Bit of Poison in a Sweet, Inviting Wrapper

2011-11-03T14:01:00.004-04:00

If you follow me on Twitter (and if you don't, why aren't you?), you have likely already heard about a PSA put out by the National Vaccine Information Center (NVIC) and Mercola.com, two slick anti-vaccine organizations. The PSA is being run on Delta Airlines flight. You can read more about it at Skepchick and Respectful Insolence. The Skepchick article includes steps you can take to combat the propaganda, including a link to a petition to get Delta to stop showing it on their flights.

The video is available on YouTube (Update: It looks like NVIC removed the video at that link, but it is still up here and here [Update: looks like it has been removed from Facebook, now, too]), but cannot be embedded. Comments have also been turned off, perhaps to avoid inconvenient critiques from science-minded individuals. On the surface, it appears to be pretty good advice, so why all the fuss?

Because the PSA includes some iffy information and, more importantly, directs people to the NVIC web site, which is rife with misinformation and distortions of fact.

Hand and Cough Hygiene

The video starts out with some very good advice, such as practicing good hand hygiene and covering your cough. We touch a lot of things throughout the day, and we touch our faces, a lot. Every object we touch, whether it be a doorknob, cup, keyboard, etc., is a potential fomite that may be carrying influenza particles. Those particles get on our hands and then are brought to our face through touching our nose, mouth, eyes, or even ingested as they move from our hands to the sandwich or potato chips we're eating. Washing your hands, thoroughly, before you touch your face can wash these particles away, thus preventing infection. If we have the flu, then washing our hands after touching our face and before touching other objects can help prevent the spread of virus particles to other people.

Likewise, if you have to sneeze or cough, cover your mouth to prevent germs being propelled into the air around you. The best thing to do is to cover your nose and mouth with your elbow. This can create a good seal, minimizing the number of particles that go out into the environment, as well as keeping your hands clean. If you cover with your hand, be sure to use a tissue or other barrier, and whether you use a barrier or not, wash your hands afterward. If you think you're helping prevent anything by coughing at the ground, well, you aren't. Always cover your cough or sneeze to prevent spreading infection to others.

Exercise and a Good Diet

The video states that exercise and diet can help you avoid getting sick from the flu. In moderation, exercise may help strengthen your immune system, but don't overdo it. There is some evidence to suggest that excessive exercise can actually impair your immune system. What exercise will not do, however, is prevent you from being infected. Whether you're a star athlete or a couch potato, if the virus makes it to you, chances are good that you will be infected. At that point, it's up to your immune system to duke it out with the virus to prevent disease.

The same can be said of diet. A balanced diet will ensure that your immune system operates at the best that it is physically capable. That said, your baseline may be better or, yes, worse, than someone else. As with exercise, having sufficient intake of nutrients will help your immune system fend off disease, but it won't prevent you from being infected.

Vitamins D and C

The PSA also mentions that vitamins D and C can help you stay healthy. While there is some evidence that maintaining adequate levels of vitamin D can aid your immune system to fight off infections, there's only so much that your body can actually use. Taking more than what your body needs will not make your immune system function better than its peak performance; your body will just try to get rid of the excess. In fact, if you take too much, it can cause some big problems. The evidence for Vitamin C is a bit more equivocal.

But again, as with exercise and diet, vitamin D and C might help fight off infection once you're exposed, but it won't prevent infection.

Vaccines

The video ends by suggesting that vaccines are another option. While it surprised me to see that they would even suggest vaccines as a means of preventing the flu, the manner in which they did so did not. NVIC's Barbara Loe Fisher presents it as an "option" and implies that it really isn't all that necessary. And while the efficacy appears to be around 59% on average, leaving ample room for improvement, it still offers a much better means of keeping you healthy than relying solely on exercise, diet and hand hygiene. And unlike exercise and diet, which basically leave your immune system to deal on its own, vaccination gives your immune system some training. It learns what to look for and how to handle it once it sees the virus. Think of it as facing a mugger. You can do your best to defend yourself just on instinct, or you can take some training, learning what to watch out for and how to most effectively deal with a threat when the mugger actually does strike.

Vaccines won't prevent the viruses entering your body, but they will significantly improve your odds of taking out the trash before you have any problems.

More Information

The PSA concludes by directing people to the NVIC web site for more information. This is where the problem lies. As already mentioned, the NVIC has an agenda to frighten people away from vaccines, through the use of misleading vaccine ingredient calculators, scare stories (e.g., Gardasil: The Damage Continues) and a wall dedicated to those who have been injured by vaccines (whether they actually were or if it was some other cause is open to debate). There is precious little that is in favor of vaccination, and certainly no tribute to individuals harmed by the diseases that vaccines prevent. It is the mix of sound advice with nonsense and pseudoscience (mercury causing autism, anyone?) that makes the NVIC a threat to public health.

In the end, Delta, and their customers, would be better served by playing a PSA that really has public health at its heart, without the ideology or dishonest spin in the NVIC spot. PSAs like these:

I encourage my readers to spread the word about the petition mentioned up above and to contact Delta to voice your displeasure that they are airing the propaganda of an anti-vaccine organization.

An Open Letter to the United States Congress

2011-11-02T12:23:00.000-04:00

Dear Members of Congress,

I recently learned that you passed, overwhelmingly, a resolution (PDF) reaffirming "In God We Trust" as the official motto of the United States. I am left to wonder, why?

Have you, unbeknown to the rest of the country, implemented legislation to help create jobs? Have you worked to improve health care? Cut down our debt? Eliminate waste?

How much time did you take away from important matters to not only vote on this, but to draft, read, refer to committee, approve and all the steps required to bring this to the full House?

Maybe I'm wrong to chastise you for wasting time on a resolution that has no power in law and accomplishes nothing to address the issues facing our nation. So let me bring up something else. When you were elected to office, you swore to uphold the Constitution. Part of that document, the supreme law of our land, is that Congress "shall make no law respecting an establishment of religion". Although the resolution is not a law, it would seem to me, as well as some of your colleagues who opposed this resolution, that the spirit of the resolution violates the principles of the First Amendment.

Beyond this, the text of the resolution makes several errors of fact.

Whereas the sentiment, "In God We Trust", has been an integral part of United States society since its founding

This is not true. While many of the founders may have placed their trust in God, it was made quite clear in the writings of several of the founding fathers that this nation was a secular one. It should further be noted that it was not even the official motto of the United States until 1956.

Whereas in times of national challenge or tragedy, the people of the United States have turned to God as their source for sustenance, protection,wisdom, strength, and direction

Although this may be true of a majority of the people, it is not true as a blanket sentiment. There are many individuals who have turned to multiple gods or to no god at all, but rather have looked to one another for comfort and solidarity.

Whereas John Adams said, "Statesmen may plan and speculate for Liberty, but it is Religion and Morality alone, which can establish the Principles upon which Freedom can securely stand."

While he may have said these words, the writers and backers of this resolution ignore what else President Adams wrote in the Treaty of Tripoli:

As the Government of the United States of America is not, in any sense, founded on the Christian religion

Concurrent Resolution 13 raises up one religion (or a class of religions) above all others. You have taken steps to exclude by sentiment those who do not believe in God, those who believe in multiple gods and those who have no belief in any deity of any sort. The language of the resolution makes it explicit that the intent of the resolution invokes religion, rather than a secular cause. Furthermore, wedding government and religion in such a manner sets a dangerous precedent. It is both bad politics and bad religion, for while Christianity is currently the dominant religion in this nation (in terms of number of practitioners), it may not always be so. Using the secular government of our nation for en explicitly religious reason such as this opens the door to further waste of time and resources, as well as the establishment of resolutions and language associated with religious matters in the future, to the detriment of all citizens of this country.

Those who drafted this resolution have shown a disrespect for the Constitution they are sworn to uphold. Those who voted in favor of this resolution have shown a disrespect for the citizens they purport to represent. Only those who, through careful thought and the courage to stay true to their duty, voted against this resolution are deserving of our praise and approbation.

I place my trust in the people around me. I trust in scientists and doctors to advance our knowledge and improve our well being. I trust in my friends, family and acquaintances, that they will do their best to improve their lot and that of everyone around them. I trust, rightly or (as evidenced by this resolution and the constant bickering along party lines) wrongly, in lawmakers to properly and truly serve all of the people they represent, not only those who happen to be in the majority or who give the most dollars.

That is a trust that you have broken. You have broken faith with the people of these United States. For the actions of people decide the fate of our nation. It is "we the people" who move this country forward. We the people will raise the nation up or, through ideology and greed, bring it crashing down.

I implore you, as individuals, elected by the people, purporting to represent our interests, do what is right and rescind this resolution. And if not, then I call upon those whose minds are like mine, to replace everyone who voted in favor of this resolution with someone who places the good of the nation, rather than the good of religion, first.

Just Answer the Question

2011-10-31T13:17:00.000-04:00

There are times that I am truly amazed at just how seemingly clueless a person can be. Often, in dealing with alternative medicine or other pseudoscientific belief systems, individuals go to great lengths to avoid answering questions that are asked. The honest believers give it a good go, doing their best to support their beliefs with what they think are legitimate sources. Sometimes, reason breaks through and plants a little seed of critical thinking, and the believer realizes that they've fallen for a lie. On the other hand, the dishonest (and by that I mean the ones who outright lie or misrepresent things) go to great lengths to dodge direct questions. They build straw men, answering questions that were never asked. They deny and obfuscate facts. They work so incredibly hard to convince everyone that the naked emperor over there is actually clothed. Generally, they have some financial stake in it, and when push comes to shove, they quietly slink away, only to trot out their erroneous claims another day.

And then you have those who appear to to be...well. There are those who seem to have a pathological avoidance of anything that would threaten their belief and who are also dishonest with both themselves and those whom they address.

Over the past several months, there has been a comment thread over at Respectful Insolence that has remained quite active, having reached over 800 comments as of today. Who could have kept things going so long? One Michael J. Dochniak. The entirety of his comments can be summed up thus:

Natural rubber latex can cause allergies.
Some people with autism have latex allergies.
Therefore, latex allergies cause autism.
Buy my book.

Notice anything missing in there? I did, and so did pretty much every other reader and commenter over at RI. The primary reason that the thread has continued for so long is that people have been trying to get Mr. Dochniak to provide even a single quality study that provides evidence of that third bullet point. Yet try as we might, Mr. Dochniak remains rather interestingly reticent about that, merely repeating everything he's already said in the thread.

The trouble, you see, is that that evidence does not exist. There are no valid, scientific papers showing that natural rubber latex of any amount, let alone any tiny traces that might leach out into vaccines, causes autism. The whole thread has been rather like watching a train wreck. It's gruesome. You feel kinda bad for the person, but you just can't look away.

And then you recall that Mr. Dochniak isn't a completely independent sort without conflicts. You see, as mentioned above, he has a book to sell, Vaccine Delivery and Autism (The Latex Connection), co-authored by Denise H. Dunn. On Amazon, it isn't doing too hot. Two scathing reviews, each of only 1 star; its sales are ranked rather low, as well. But that's not all. Mr. Dochniak is also a patent holder for alternatives to latex sealants and adhesives. He also tried petitioning the EPA to ban natural rubber latex back in 2008. The EPA said "No" because he provided no evidence for any justification for its being banned.

I won't go into all of the errors Mr. Dochniak makes in his arguments about immunology or the scientific process. You can go over to Respectful Insolence to see the whole sordid affair. In the end, it is hard to say if he is simply a money-grubbing huckster trying desperately to sell his idea or if he is truly deluded and actually believes what he claims. His constant evasions could be due to his attempts to make money off his book and a latex alternative, or they may be the result of a psychologically disturbed mind trying to defend its delusions. Of course, I could be completely wrong on all of this. There is the very remote possibility that he might actually be right, but I can't really say, since he won't pony up the evidence being asked of him over and over that latex allergies can cause autism.

Mr. Dochniak, and all the other cranks out there, just answer the question.

Quacktion Figure™ Friday: Anti-Vaccine Researcher

2011-10-28T00:01:00.006-04:00

Ever wanted to enjoy the adoration of tens of others? Had an idea for a new product to patent, but had pesky competitors that needed discrediting? Have you ever dreamed of creating a controversy where there was none? Have you thought that violating research ethics would be a quick way to accomplish all this, but never had the narcissistic chutzpah to pull it off?

Well, now you can. Harpocrates Speaks brings you Anti-Vaccine Researcher!

Anti-Vaccine Researcher

Now you, too, can fake data for a paper and have it retracted. With Anti-Vaccine Researcher, you can pay children £5 each to bleed 'em dry! Cry, "Conspiracy!" to your adoring fans and hold your own medical practice board hearing where you can choose not to present any evidence in your own defense!

Anti-Vaccine Researcher stands 5¾" tall and comes with:

£5 Note
Vial of Blood
Retracted Paper

Self-aggrandizing book of fiction sold separately.

The Fine Print
Figure not actually for sale. Figure and text intended as a work of satire. Image copyright Todd W. and Lil Peck. Quacktion Figure™ is a trademark of Todd W. and Harpocrates Speaks.

Complete Quacktion Figure™ series

Announcing "Quacktion Figures™"!

2011-10-24T00:00:00.007-04:00

If you read this blog, chances are, you're more of a reality-based individual. You prefer good, hard evidence over stories from your friend's brother's girlfriend's cousin's former roommate's grandfather's ex-military buddy. When it comes to medicine, you like the kind that actually works, that really improves your health rather than just making you think you're better while your liver is gasping for life. You probably look at scam artists and think, "If only I lacked ethics, I could rake it in just like that guy."

Well, fear no more. Announcing Quacktion Figures™! Now you can pretend with the best of them. Objective improvements, smobjective improvements. What matters is how the patient feels, not whether their cancer actually goes away!

Over the next several weeks, I will be putting up a new quacktion figure every Friday. Be forewarned; these are meant as satire. For the humor-impaired, please take a look at New Times v. Isaacks.

Also, I have to give a well-deserved shout-out to the artist who helped me give form to my idea. Lil Peck put in quite a bit of time to give form to each of the figures. Show her some love.

Finally, these only exist in digital form and are unavailable for actual sale, so, sorry, no stocking stuffers for you (though I think it would be amazing if someone actually built some of these).

Stay tuned!

Quacktion Figure™ is a trademark of Todd W. and Harpocrates Speaks.

Complete Quacktion Figure™ series

Censored on Best of Age of Autism: Paul Offit and the Original Sin

2011-10-22T12:48:00.004-04:00

A while back, JB Handley made a deal. He bet that if the author Sullivan over at Left Brain/Right Brain was not Bonnie Offit, wife of Dr. Paul Offit, he would never write about Dr. Offit again.

Well, it seems he is, at the very least, passively violating that agreement, as evidenced by a new post up at Age of Autism titled "Best of Age of Autism: Paul Offit and the Original Sin". If Handley has any integrity, as one of the editors/contributors at Age of Autism, he will take the post down. I've left a comment over there to that effect, which I copy here:

Click to enlarge.

Readers, head on over there and let yourselves be heard. Be sure to save a copy of any comments you leave, which you can post here. If you do comment there, however, be sure to follow their commenting policy, so that they have no real excuse to moderate your comment out of existence.

Update: Here is Liz's screen shot of the comment she left below:

Click to enlarge.

Wanted: Virus and Bacteria Mug Shots

2011-10-21T13:31:00.003-04:00

Just putting a brief call out to anyone that has the means of taking photos of viruses and bacteria. I would like some pics of the organisms that cause vaccine-preventable diseases. Namely, the following:

Bordetella pertussis
Clostridium tetani
Corynebacterium diphtheriae
Haemophilus influenzae type b
Hepatitis A Virus
Hepatitis B Virus
Human papillomavirus
Influenza Virus
Measles Virus
Mumps Virus
Neisseria meningitidis
Poliovirus
Rotavirus
Rubella
Streptococcus pneumoniae
Varicella (Herpes Zoster Virus)

The picture should show the individual virus or bacteria and must be your own; no third-party pics, please. Photos are preferred, though digital artwork depicting the particles/organisms works, too. The images should be something similar to what one can find on the Public Health Image Library (which I could use, but would prefer to get pictures over which I can have full use rights). If you have images for which you are willing to give me the rights to use for a project, please contact me at todd [at] harpocratesspeaks [dot] com. Deadline is October 31, 2011. Credit will be given, though no remuneration will be provided.

Who Stopped the Rain?

2011-10-17T13:17:00.000-04:00

The other day, I was reminded of something that happened to me many years ago, when I was a little younger and much more naive. At the time, I was living in Japan and had to walk pretty much everywhere I wanted to go. That put me outside for rather extended periods of time pretty frequently, which also meant that I was in the rain for longer stretches than I otherwise would have been back in the United States, where I drove anywhere I needed to go. It also happened that I was, at the time, rather enamored of the New Age-y pseudo-Celtic mythology, which revered nature, espoused spirit guides and purported to teach the follower the means to manipulate energy to influence the world around us. I had come to these beliefs in part out of a sense of disenchantment with my Christian upbringing and organized religion in general, as well as a youthful conceit that I could somehow control the uncontrollable.

These things came together one spring day, as I was heading, if I recall correctly, to university.

There was a light, but steady rain, which became a downpour. Despite my umbrella, I took shelter under an overhang to wait it out, and as I did so, I repeated a single thought: "Rain, lighten up." After a few minutes of this, the rain let up significantly, allowing me to continue on my way. I wasn't certain if I had any influence on the outcome, but thought I would give it a try the next time I was out in the rain.

Fast forward to the next rainfall that caught me outside. Sure enough, there was another downpour. Once more, I took shelter under an overhang and, remembering my previous experience, I repeated my mental mantra: "Rain, lighten up." Just as before, it only took a few minutes before the rain let up, and I continued on my way. This strengthened my belief that I was somehow influencing the weather. I mean, once could be a fluke, but twice in a row? And I was confirmed in my beliefs throughout the rest of the spring, summer and autumn, with repeated experiences, all with the same results.

I attributed these experiences to my somehow working "magic", controlling the energies of the world around me to effect an outcome I desired. I don't recall any instance where I tried these efforts and failed. Later, when a close friend converted me back to Christianity and I explained my experiences, it was attributed to Faith, and that that alone could work wonders, but when it was placed in God, even more could be accomplished.

More time passes and I take a more objective look at things. I ask how likely it was that I really and truly had a real effect on the weather? I took time to observe how rain typically behaves. Was there some pattern that just happened to coincide with my own actions? Although I was beginning to turn to a more scientific approach to viewing the world around me, what I discovered was a bit of a slap in the face. It turned out that, at least in the temperate climates I have found myself, heavy downpours typically only last a handful of minutes. Waiting just a little while was usually all that was needed. The likelihood that I really affected the weather went *poof*. I was just attributing two things that, by chance, occurred around the same time as having a cause-effect connection to one another. And, since those coincidences were significant to me, I remembered them but not any of the instances where it didn't work. In short, I was engaging in something that everyone does. I confused correlation with causation and reinforced that confusion through confirmation bias.

As pattern-seeking creatures, we humans have a very strong tendency to look for connections between things. It helps us make sense of the world around us and to cope with that which might be beyond our control. Similar to my experiences are those who think that they cause street lights to go out when they walk under them. The same thing happens in the world of medicine, especially with alternative medicine. When we suffer from some illness, we may try different things to alleviate our symptoms, and whatever we happen to be taking just before we start to improve, we view as causing our recovery, even though it may simply be the natural course of the illness. We also see this happen in the whole vaccine-autism manufactroversy. Coincidental timing leads some to think that vaccines cause autism, despite mounds of evidence to the contrary. The Church of the Flying Spaghetti Monster illustrates this idea through its analysis of the connection between pirates and global warming.

I'm not disparaging anyone for falling victim to this error in logic and thinking. I've done it before; I will very likely do it again. The trick is to understand how we slip into this way of thinking and try our best to be vigilant of our own thoughts and behaviors, not to mention understanding how our strongly held beliefs can influence the weight of evidence we use to support our own ideas and shoot down conflicting ones.

When we see what we think are sound correlations between two events, there are some questions to ask:

How plausible is it that event A caused event B, based on what we know of the universe?
Has there ever been an instance in the past where A caused B, with sound evidence to back this up?
How are my own beliefs influencing my perceptions and observations?
What details might I be missing or unaware of?

If we really want to be honest with ourselves, we need to test our beliefs and try to prove ourselves wrong, especially where a causal connection is tenuous at best and we find ourselves making a lot of ad hoc rationalizations to support a connection. That's the hard part, especially when a belief is so strongly held that we invest our own sense of self into it; if the belief is wrong, then I, myself, must be flawed. If the evidence showing we are wrong comes from someone else, we may take it as a personal affront, that they are attacking us as people, rather than just our ideas. We may rant and rave, use whatever is at our disposal to rationalize away their evidence or even attack them personally through ad hominems.

It is important to understand, though, that seeing correlations is part of how we are wired. We evolved to see these things in order to help us survive in the wild. It's human nature and nothing to be ashamed of, unless we persist in the face of all evidence otherwise. Learn to separate yourself as a person from the ideas that you hold.

Apparent correlations can be very useful to direct a more careful inquiry and investigation, but they are seldom sufficient to make any concrete claims. In the words of the ancient Greeks, "Know thyself," and ask, was it really me that stopped the rain?

Happy Brave Maverick Day!

2011-10-10T13:10:00.000-04:00

In the United States, today, the second Monday in October, is Columbus Day, a holiday recognizing the landing of Christopher Columbus on the shores of the New World. On October 12, 1492, Columbus arrived landed on the island now known as San Salvador, in the Bahamas. Many celebrate the day as the discovery of America. A popular, though erroneous, belief is that Columbus flaunted common thought that Earth was flat, venturing out across the western waves to prove that the planet was, in fact round, and he is often held up as a model of how one man with conviction can prove not just popular opinion, but science itself, wrong.

Portrait of a "brave maverick".

In fact, cranks of all stripes tend to bring up Columbus to support their fringe ideas, secure in the belief that they will be vindicated. Perhaps if they knew a little more about Columbus, they might not be quite so eager to compare themselves to him.

There are actually a lot of similarities between Christopher Columbus and modern day purveyors of crackpot notions. They both display a certain misunderstanding or poor grasp of the science of the day. They tend to glom on to ideas that may not necessarily be supported by facts. There is a certain self-absorption that they are right and that all others are wrong, motivated by greed and self-aggrandizement. And they may seek to dupe wealthy and/or influential people into backing them, financially and politically. Finally, they ultimately prey upon and exploit others for their own gain.

Some Background

First we need to set the scene. Columbus tried shopping his idea of a shorter route to the Orient by traveling west, rather than the known route south around the tip of Africa, a journey fraught with dangers, not least of which were the storms of the southern seas. He tried going to the Portuguese court several times, whose experts rejected his plans, judging his calculations to be too low. He also tried Genoa and Venice, but found no support there. He tried England, as well, but found support from the crown of Spain before an invitation from Henry VII came. Spain had just conquered the only remaining Muslim stronghold on the Iberian peninsula, Granada. A financially strapped Spain needed an edge over their European rivals for trade with the Far East, and Columbus offered them that hope. In April 1492, he finally received the funding he had been searching for to find a faster route to the Far East by sailing west. The only problem was that he was wrong.

Misinterpreting the Science

Columbus' first mistake was that he got his measurements wrong. And not just a little wrong, but woefully, horribly wrong. Rather than using the well-established and remarkably accurate calculations of Eratosthenes, made in the 3rd century BCE. Columbus made several errors in this regard. In calculating miles per degree of longitude, he incorrectly thought that the Arab mile of Al Ma'mun was equivalent to the Roman mile. This basic error threw off all other calculations he made. For example, using his numbers, he stated the Earth had a circumference of 30,200 km, rather than the actual 40,075 km. He also overestimated the size of the Eurasian landmass. Scholars of the day accepted Ptolemy's estimate of approximately 180º. Columbus used a much larger estimate of 225º and compounded the error by his belief that Japan was much further from China than it really was, leading to a calculated distance from the Canary Islands to Japan to be about 3,700 km instead of the actual roughly 19,000km.

If there hadn't been any land where the Americas are, it is very likely that Columbus and his crews would have been lost at sea, condemned to starvation, thirst and endlessly roaming the waves. Eventually, their ships would have run aground or befouled some other vessels, long after all hands had died. It was only by an accident of geology that Columbus and his crews survived and gained fame.

In similar fashion, purveyors of nonsense often misinterpret current science, abusing things like quantum mechanics or even using quaint notions of biology that are easily countered by facts. Their notions are often opposed by experts in relevant fields, and quite rightly, though these cranks may, by accident, stumble upon something that may actually prove useful or valid. But it is not through anything they did correctly; rather, they just happened to be in the right place at the right time, like finding a $20 bill on the ground.

Patronage and Greed

Columbus did not have the resources himself to fund his expedition, so he needed backers. He didn't hold fundraisers or bake sales. He didn't sell products that actually had some value. Instead, he went to powerful and influential individuals with an idea. The royals of Portugal, the merchant-princes of Genoa and Venice, the king of England and the king and queen of Spain were all his targets. He promised them a shorter route to the East, presenting no evidence to support his convictions other than arguments by assertion. In return, he wanted funding for his voyage, but he didn't stop there. The final contract between Columbus and the crown of Spain named him Admiral, Viceroy and Governor of any lands he discovered and conquered and become Spanish nobility. His children would also attain those titles after him. He also wanted 10% of all trade revenue from any of the lands he should discover.

Many, if not all, of those "brave mavericks" out there court fame and fortune, sometimes finding powerful patrons, such as Oprah Winfrey or Prince Charles, to elevate them to public attention. They may gain investors based on nothing but promises, like the free-energy company, Steorn, which continues to promise and promise and promise, but presents no results, all the while raking in money from investors. They sell books, cure-alls, supplements and so on.

Exploitation

Which brings us to the final bit: exploitation. Columbus saw great opportunity in the native populations he conquered. In the first several days after discovery, he wrote:

It appears to me, that the people are ingenious, and would be good servants...I could conquer the whole of them with fifty men, and govern them as I pleased.

In fact, he went on to take many natives as slaves. He took their gold and resources and is reputed as being something of a tyrant in his governorship, even toward Spanish colonists. He began an era of oppression in which native peoples were dispossessed of their lands and belongings, their freedom and, through war and disease, their lives.

Cranks, likewise, abuse their marks. They part the unwary from their money, selling dubious products. As Columbus preyed upon the kindness and general good will of the natives, purveyors of woo prey upon the emotions and hopes of those dealing with health issues, grievous events and so on. Their own profit and self-interests come before their victims, before people who deserve far better. Because of those who buck the system, convinced that their ideas have value despite all science and reality to the contrary, other people suffer. Those with health issues, some potentially fatal, end up spending precious time and money on purported cures that do nothing but give false hope, where they may have otherwise had a much improved chance of survival. Those who grieve for lost loved ones are parted from their money, as are those who want an easy fix or free energy. In the end, the only one who truly profits is the one perpetrating the scam.

A Day of Celebration

So, here's to all of the brave mavericks out there. A day to celebrate woeful ignorance and abuse of science, self-aggrandizement and the exploitation of others. When you choose to compare yourself to Christopher Columbus, keep in mind what you're really comparing yourself to: an opportunist in it for himself, horribly ignorant and callous toward others. By a happy chance, you might happen upon something that's actually useful, but you'll still be wrong and others will still suffer for it. Cheers!

Disturbing Findings on Measles Immunization in India

2011-10-03T13:20:00.000-04:00

Over the weekend, I saw a news story from India Express on the measles vaccine in that country. Titled "Measles vaccine protects only 1 out of 5 children in Delhi: Study," the article discusses a recent study that found poor efficacy for measles vaccine among Indian children after a single dose. Since the news article did not provide a link to the study, I had to poke around a bit to find it. Appearing in the Indian Journal of Medical Research, Immune response to second dose of MMR vaccine in Indian children (PDF), by Sunil Gomber, Shilpa Khanna Arora, Shukla Das and V.G. Ramachandran, examines the seroprotection of MMR against measles, mumps and rubella, as well as the immune response to a second dose of MMR. Unlike in the United States, the MMR is not part of the national recommended immunization schedule. The Indian state of Delhi, however, does include a single dose of MMR given at 15-18 months of age.

Before diving into the study, we need to get an idea of the state of things in India.

Some Background

The authors ask some important questions for India, which has a huge population (PDF) (1.02 billion people as of a 2001 census and 25.6 million surviving live births in 2004). In such a crowded country, measles, a virus which infects 90% or more of susceptible people who are exposed, can have a very big impact and has the potential to spread very quickly. Many cases, even with complications, never make it to public sector hospitals, which are the ones collecting and reporting data on measles incidence. This means that there is gross underreporting of both incidence of the disease and complications and deaths from the virus. Complicating things is that many parents and health care workers, including some physicians, view the disease as minor and not something to worry about, even though there is an average case fatality ratio of 3.7% in the country. Some Indian states report no cases at all, while others report as many as 142.7 cases per 100,000 people. There has also been some discrepancy between reported vaccination coverage and directly evaluated coverage:

Particularly in rural areas of India with inadequate medical infrastructure and among the poor who cannot afford the vaccine and who often suffer from malnourishment, measles presents a significant health problem. Experience from other countries, such as the U.S., have shown that the MMR vaccine can be very effective after even a single dose, and has a long history of safe use. Understanding how the vaccine functions under the Indian paradigm, then, is very important.

The Study

Unlike the United States, which generally recommends the first dose of MMR at around 12-15 months of age, due to the burden of disease upon the Indian population and high incidence, routine recommendations are for a measles vaccine to be given around 9 months of age. Ther is one drawback to this, though, as the authors note (PDF):

Seroconversion for measles is slightly lower in children who receive the first dose before or at 12 months of age (87% at 9 months, 95% at 12 months and 98% at 15 months) because of persisting maternal antibodies^2,3.

So while working toward conveying protection as early as possible, there is potential for the vaccine to fail due to maternal antibodies attacking the weakened vaccine strain viruses if given too early.

The researchers included healthy children 4-6 years old who had documented evidence of measles vaccine in infancy and one dose of MMR at 12-24 months of age who attended an immunization clinic to receive a DT (diphtheria and tetanus) booster. Blood samples were collected, and then MMR-II (Tresivac, made by Serum Institute of India Ltd, Pune) was administered subcutaneously. Children returned after 4-6 weeks for a followup exam, at which another blood sample was drawn. Protection against measles, mumps and rubella was determined by examining antibody titres. What they found was rather surprising:

Only about 1 out of every 5 children displayed antibody level suggestive of protection against measles before the MMR-II was administered. This contrasts sharply with what had been seen in a number of other studies, where seroprotection after a single dose ranged from 69%-98%. Even a second dose of measles-containing vaccine produced a lower level of protection (73% compared to 97%-100% protection). What is going on? Why are so many Indian children poorly protected against measles at 4-6 years of age, even though they had received a measles vaccine at around 9 months and an MMR vaccine at 12-24 months?

The most likely explanation, and one which the authors speculate, is that maternal antibodies reduce the efficacy of the first dose of measles vaccine, leading to lower antibody levels and poorer response to subsequent vaccination, as has been demonstrated in other studies. Part of determining the best time to vaccinate involves looking not only at getting protection against diseases as early as possible, but also ensuring the the vaccine works properly at those ages. This study, along with others examining early immunization, suggests that vaccinating against measles before 12 months of age may lead to inadequate immunity from the vaccine, leaving children susceptible to later infection.

It is also possible that the vaccines given to the children in infancy and at 12-24 months were from bad lots. Unfortunately, this study was not designed to distinguish between vaccines which were, in and of themselves, ineffective and vaccines that failed due to maternal antibodies. The authors wisely call for further research, as well as re-evaluation of the recommended vaccination schedule.

Given the burden of measles in India, combined with the state of health care and their medical infrastructure, health policy advocates must take a serious and close look at the current recommendations to ensure the health of their children. If further research supports this study's findings, then officials in India must adjust their recommendations and practices. Improvements in the recommendations will go a good way toward eliminating measles from that country, but it is still only a part of the battle. Misconceptions about the disease and disparities in health care must also be addressed.

On the Impact of a Flu Vaccine and Health Care Workers

2011-09-29T13:26:00.000-04:00

The latest issue of the CDC's Morbidity and Mortality Weekly Report contains a notice to readers, advising them of revisions that were made to the estimated impact of the 2009 H1N1 Influenza vaccine. Before I get into the specifics of the notice, I just want to point out how cool it is that organizations like the CDC that are based in science will readily correct themselves, even before anyone outside the organization points out an error. This is something that I don't think I've ever seen from an anti-vaccine organization, even when glaring errors are highlighted for them.

So, what does the CDC say?

In the May 20, 2011, report, "Ten Great Public Health Achievements --- United States, 2001--2010," on page 621, preliminary estimates of the impact of public health interventions during the 2009 H1N1 pandemic were presented as follows: "These public health interventions prevented an estimated 5--10 million cases, 30,000 hospitalizations, and 1,500 deaths (1)." These estimates were derived using combined data from two sources: 1) an unpublished CDC model for estimating the impact of the 2009 H1N1 pandemic influenza vaccine on averting cases, hospitalizations, and deaths during the 2009--10 influenza season and 2) a model for estimating the impact of antiviral treatment in averting hospitalizations and deaths during the 2009--10 season (2). As a result of a programming error, the model used to estimate the impact of vaccination did not adequately adjust for the decreasing risk for disease as the pandemic progressed, and thus the impact of vaccination was overestimated.

The corrected estimates for the combined impact from vaccine and antiviral treatment are as follows: 713,000 to 1.5 million cases, 12,300 to 23,000 hospitalizations, and 620 to 1,160 deaths averted. Of these, 713,000 to 1.5 million cases, 3,900 to 10,400 hospitalizations, and 200 to 520 deaths were averted as a result of the vaccination campaign (CDC, unpublished data, 2011), whereas the use of influenza antiviral medications is estimated to have prevented another 8,400 to 12,600 hospitalizations and another 420 to 640 deaths (2).

The model that they used for the May 20 report was wrong. As they state, it did not take into account decreasing risk of infection as the pandemic progressed. This deceased risk came about for several reasons: people became infected and so were no longer potential hosts; people were immunized and were no longer susceptible to infection; people may have taken extra precautions (covering coughs/washing hands) to prevent infection/spread; communities reached a level of immunity that protected those who had not been vaccinated. Because of the reduced risk of infection as time passed, the impact of vaccinating decreased.

Now, it's important to note that these revisions do not affect estimates of the efficacy of the H1N1 vaccine. When it was used, it did a very, very good job of preventing infection, since the vaccine strain matched the circulating strain. Rather, as the number of immune individuals goes up, the number of susceptible people goes down, and so the vaccine will have less and less impact on the spread of influenza as time goes on. Also bear in mind that estimates of the burden of the H1N1 pandemic have not been affected by the error in the model of the vaccine's impact. There were still just as many cases that actually did occur, including cases before the vaccine was available. As the CDC notes, the pandemic:

resulted in approximately 43 million to 89 million cases, 195,000 to 403,000 hospitalizations, and 8,900 to 18,300 deaths, including 910 to 1,880 deaths among children aged <18 years, during April 2009--April 2010 (3).

Speaking of the Flu

While we're on the subject, as temperatures drop, the air becomes drier and people start to congregate indoors more frequently, flu season starts to ramp up. Conditions are becoming ripe for transmission of the virus, and hospitals are places where we really cannot afford to spread the flu. There are a lot of individuals whose immune systems are less able to cope with infection, so even illnesses that might be mild in a healthy individual may become life-threatening. Whether the patients are walk-ins or in for long term care, children, adults or the elderly, it is vital for hospital employees to be vaccinated against the flu.

I'm not just talking about the doctors and nurses, here. I mean everyone that works in the hospital. At the very least, anyone who spends any amount of time in a patient area (waiting room, exam room, elevators, hallways, stairwells, lobbies) should be immunized if they have no medical reasons to the contrary. Hospitals and their employees should take steps to protect the health and well-being of their patients, and that includes taking measures to reduce the risk of infection.

I decided to take a look online to see if I could find any recent reports of vaccine rates among hospital employees and stumbled upon a survey of Maryland Hospital Healthcare Worker Influenza Vaccination (PDF). This was a self-reported, web-based survey of Maryland hospitals looking at total number of employees who received a vaccine, number that exempted out for medical reasons, number that exempted out for religious reasons and number that declined immunization but did not provide a reason, compared to the total number of employees at the hospital. Some hospitals had mandatory immunization policies with consequences for non-compliance (such as loss of privileges or even being fired), some had mandatory policies but no consequences for non-compliance and still others had no vaccination policy.

In general, the hospitals that had some form of mandatory immunization policy had very good vaccination rates, above 90%, with only two exceptions:

Even without mandatory vaccination policies, there were quite a few with >90% immunization rates:

I'm not sure I buy those ones that report 100% rates, though. Statistically speaking, in any given hospital, there ought to be at least one person who opts out, for medical, religious or philosophical reasons. That makes me wonder how honest those hospitals were being when they answered the survey, especially since it doesn't appear there was any protocol in place to verify reported vaccination rates. If they are inflating their success rates, this gives an erroneous and potentially dangerous picture of their infection prevention procedures. Of course, it's always possible that they simply fired anyone who didn't vaccinate, regardless of reason; in that case, of course they'd have 100% compliance, though I imagine it would be a bad place to work.

Unfortunately, there were also hospitals with rates under 60%:

These institutions were probably being quite honest about their own immunization rates, which, sadly, paints them in a rather negative light when it comes to protecting their patients. Clearly, there is significant room for improvement at these hospitals when it comes to protecting their patients from influenza.

Some may argue that hospitals have no right to force their employees to be vaccinated. Well, yes and no. Their job is to ensure the safety and health of their patients, and part of that is preventing infection wherever possible. Those who disagree with that are clearly working for the wrong place. On the other hand, options should be provided for those who cannot, due to medical reasons, receive a flu shot. Those who cannot or will not get a flu shot should be required to wear one of these guys from before they enter any patient area until they leave a patient area:

An N95 Personal Respirator

If an employee is not willing to either get the shot or wear one of these masks, then it is fully within the hospital's rights to take corrective action, up to and including termination of employment. An employee that does not put the patients first and foremost is an employee that is not doing their job.

This is just a sampling of data. Although it might not be truly accurate, it does give some sense of how hospitals are doing in preventing the spread of the flu. If you work at a hospital, do your duty: get immunized or invest in a mask.

Last Chance to Stop the Unjust Execution of Troy Davis

2011-09-21T11:04:00.004-04:00

A brief appeal from my pal, René Najera:

Throughout my life, I have gone back and forth on the issue of the death penalty. Back in Texas, death sentences were carried out often while I was living there. Every couple of weeks, it seemed, the local media covered an execution, showing pictures and video of protests outside the prison. Some people would protest that the death penalty was archaic and unnecessary in a modern era and a modern country. Others would protest that the most horrible crimes needed the absolute punishment. For some time, I agreed with the latter. I agreed that some crimes were so heinous and unforgivable so as to deserve the death penalty. I saw the death penalty as a clean and almost surgical procedure and an unfair way for someone to exit this world when compared to how then killed someone else.

As I grew and matured, I came to see the death penalty as something else altogether. It doesn't stand for justice anymore, in my mind. As far as I am concerned, it is plain vengeance. The families of the victims demand it not because they want justice. They just want someone, anyone, to pay for the crime which took their loved ones away. I see it in the faces of the mothers, fathers, and siblings who are interviewed after a big case is closed and the verdict calls for death. And I see it when those same families show up to witness the execution.

I just don't believe in vengeance. I believe in justice.

Look at the case of Troy Davis, a man convicted of murdering a police officer 20 years ago. Seven of the witnesses who testified against him recanted their stories. Some of those witnesses stated that they were coerced by police to say what they said in court. There is no physical evidence linking Davis to the murder, not even a murder weapon, let alone intent. Further, one of the jurors has come forward stating that evidence in the case did not present the whole picture of what happened. And another person has been suspected of being the murderer for quite some time now. (I checked the Wikipedia entry against sources, and they all check out. You can read it here.)

At the very least, Troy Davis deserves a new trial.

Why not a full exoneration? Well, because a grand jury did indict him, and another jury did find him guilty. There was evidence against him, and not all the witnesses changed their stories. As Amnesty International has stated, there is just too much doubt about the validity of the evidence that led to the conviction.

There is also a bigger picture look at this case as well. In the bigger scheme of things, if Davis is executed and later found to be innocent because someone confesses to the crime or some other evidence is found that exonerates him, that will cast an enormous cloud of doubt over the entire justice system. It would be a cloud bigger than the one that hangs over it today as a disproportionate number of people from minority backgrounds get convicted at a higher rate and with harsher sentences. As a society, we need to trust our justice system. We need to know that the police will not make up charges against us so that we can report the real crimes to them and live in peace and prosperity. We need to trust our judges to take into account all the evidence so that we can hold responsible all the people who would do harm to us and our country. And we need to know that juries will not be manipulated by District Attorneys who want to score political points.

We need to know that not one innocent person spends one day in jail or, worse, is executed. Otherwise, we're pretty much screwed (to put it mildly). We're no better than a Banana Republic or a Failed State...

When asked about the attention the Davis case is attracting, the mother of the victim answered: "I just think they should stay away. They don't know the case, they're just running their mouths," says Anneliese MacPhail, the slain officer's mother. "It's none of their business. They don't know all the circumstances."

No, we don't, Mrs. MacPhail... As a country, a society, as human beings, we desperately need to.

TO HELP BRING THIS CASE BACK TO THE COURTS AND STOP THE EXECUTION, PLEASE VISIT:

AMNESTY INTERNATIONAL

CHANGE.ORG

and NAACP.ORG

Disappointing Coverage of Pertussis Vaccine Findings

2011-09-20T15:42:00.001-04:00

Pertussis has been in the news a fair bit recently. Actually, it's the vaccine against pertussis that has garnered a lot of attention after a recent presentation and study from the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy. The presentation, Marked Acellular Pertussis Vaccine Failure in 8-14 Year-olds in a North American Outbreak, suggests that immunity from the pertussis vaccine can wane in as little as 3 years, covered a study by Kaiser Permanente Medical Center under the supervision of Dr. David Witt.

The story has been picked up by a lot of media outlets, such as the Associated Press and subsequently regurgitated in places like ABC News, The Boston Globe and The San Francisco Chronicle. While the story raises some valid questions, there are some problems with how it is being presented.

First and foremost, the spin on the study is that the waning immunity from the pertussis vaccine is somehow new and shocking, something that we did not know about before. We've know since at least 2005, if not earlier, that immunity from the vaccine ranges from about 4-12 years. Similarly, immunity following natural infection with Bordetella pertussis, the bacterium that causes whooping cough, wanes in about 4-20 years. This is not news. It's something we have known for a while, yet not one of the news stories covering this subject mentions the fact, nor does it seem that the Witt et al. acknowledge this fact. From the abstract, the authors state that "acellular boosters appear to be ineffective after 3 years." This seems to overstate things a bit. Are the boosters truly ineffective, or does the efficacy simply start to wane?

Speaking of efficacy, it is unclear from media reports and the presentation abstract whether the researchers controlled for the failure rate of the vaccine. According to the CDC Pink Book chapter on Pertussis, acellular pertussis vaccines have an efficacy of around 80%-85% (PDF). That means that for every 100 individuals who complete the vaccination series, there will be around 15-20 who will not develop immunity. The selection methods, picking anyone with a positive PCR for B. pertussis, may be sufficient to control for this, but it is something that is worth mentioning, to put things in context.

This brings us to a couple other issues: case definitions and population selection. Notably, the methods used by the authors to select cases for their study differ from the case definitions used by the CDC, which include the duration of cough and additional symptoms in addition to a positive PCR. It is possible for PCR to give a false positive, especially if samples are taken in a location which also administers or handles pertussis vaccines. The technique only requires a piece of genetic material, not the entire bacterium, to produce a positive result. It is therefore possible that PCR alone may indicate a patient is infected with pertussis when they actually have a different respiratory illness. It is not clear how Witt et al. controlled for false positives from the PCR.

What was also missing from both the study and the media reports was a sampling of the population who had received the vaccine in a similar timeframe to the 132 clinical cases identified, who had been exposed to the bacteria, yet who did not develop clinical illness. We know that in the 132 cases in the study, immunity waned in as little as 3 years. However, the level to which this represents the community at large is unknown. How many individuals were exposed to pertussis but remained immune thanks to the vaccine?

These are all very important questions which were not even glossed over in media accounts. They simply weren't considered at all. The down side of this is that the media reports play into anti-vaccine propaganda that the vaccines "don't work" or that because they may provide only short-term immunity, then "what's the point?" The acellular pertussis vaccines do have shortcomings; immunity can wane and efficacy is not as good as other vaccines. There is certainly room to improve it in terms of both efficacy and duration of immunity. However, the fact remains that it is pretty effective and immunity can last for much longer than 3 years. It has had a tremendous impact on overall pertussis rates, reducing incidence of disease by nearly 80% since it was first introduced (see the Pink Book link above). The triumph of this vaccine has meant that significantly fewer infants die from this disease and non-fatal complications are far less common in the population at large.

In the end, I have been extraordinarily disappointed in the media coverage of the new study. It has lacked basic investigation into what we already know of the science behind the vaccine and ignored the nuance of the subject. To all the science journalists out there, let's try to raise the bar a bit.

Seeing the Value of Graffiti

2011-09-19T13:45:00.000-04:00

Blogging is not writing. It's just graffiti with punctuation.
--Dr. Ian Sussman, in Contagion

I went to see the new movie Contagion the other day. Over all, it was a decent flick. It was much more refreshing than other disease-based disaster movies, like Outbreak or The Andromeda Strain, in that the crew worked hard to get the science right. Also nice was that when characters died from the virus, there was no drawn-out "I'm dying; oh, the pain" dialogues with other characters. Like a real virus, death was heralded by serious awareness-hampering things like seizures. There were some quibbles I had with the film, but I'm not going to go into a lengthy review. Others have already done that far better than I could. Besides, I don't want to give any spoilers for those who have yet to see it.

Instead, I want to focus on that quote up at the top of this post.

The line was from Elliott Gould's character Dr. Ian Sussman, a professor and researcher in infectious diseases, as anti-vaccine crank alt-med blogger, self-styled journalist and supplement huckster Alan Krumwiede (Jude Law) harangues him as Sussman leaves work. That line, I think, nicely encapsulates the opinions of many people around the United States, and probably the world over, who don't really "get" what blogging is all about. Some bloggers take that comment as a compliment, a badge of honor, since graffiti is an art form that can last significantly longer than most blog posts. To the average person, though, it would probably seem the witty insult that it is; like graffiti, many blogs are little more than nonsense cluttering up the (less than) pristine walls of the internet.

For the average person going about their daily lives, ignoring the blogosphere probably will not have a significant impact on them. They might miss out on some intriguing philosophical discussion, learn some cutting-edge science or just find out a new recipe to throw into the dinner meal rotation. In short, they probably are not going to ruin their lives by dismissing blogs as nonsense to be ignored.

That's a dangerous attitude, though, for individuals in the public health realm. It might not be risky for them, personally, but it can have a rather insidious impact on society. In the movie, Krumwiede claims to have millions of "unique" visitors to his site every day. As Orac notes, his character is not dissimilar to Mike Adams, who has a popular web site with hundreds of thousands of followers and who has many a product to hawk from his online store. Public health officials who view blogs like his as trivial, believing that they have little impact, do their organizations and their mission of promoting public health great disservice.

There are certainly administrative sorts out there who think that when people have questions about health, they go to their doctors and actually listen to them. Certainly, that seems like common sense. You're sick; you go to the doctor; you listen to the doctor; you get better. That they might go online to find information and read (gasp!) blogs seems absurd to them. They seem to believe that handouts and fliers are an effective means of educating people about health topics. I'm not quite certain whether this attitude is born of luddism or from a sort of arrogance that assumes people listen to doctors because doctors "know best."

Suffice to say that while fliers and the like can reach some people, it is not particularly effective in the online age. A more sophisticated approach is called for, one that takes on the task of answering people's questions in new, innovative and multi-pronged ways. People are becoming more and more accustomed to turning to the internet and the wisdom of random strangers, personal stories and such to find the answers to what ails them. They want answers that are easy to find, easy to understand and reassure them that everything will be okay. Public health institutions need to meet their needs. Right now, people like Mike Adams and, to a much lesser degree, Age of Autism, have the edge on marketing their ideologies and, especially in the case of Adams, their products. Science- and reality-based information needs to be ready to hand in a manner that is easy to understand and satisfies the emotional aspects of patients' quests for answers. The goal shouldn't be to persuade the die-hard conspiracy theorists, but rather to reach people before they get to that point.

Sadly, there are individuals in public health who just don't get it and who will not move forward. As I said when discussing this topic with some friends recently, "a large organization, whether it be a university or a Federal government, technologically advances only as fast as the biggest luddite in management will allow." Officials will ignore such an insight to their peril and to the detriment of those they are supposed to serve.

Big Fruit Is Trying to Poison You...or Not

2011-09-15T13:00:00.007-04:00

People in positions of authority or renown ought to be careful with what they say and do. They are held to a higher standard because their actions can often have a rather influential effect on the public at large. A simple comment may be enough to sway how we think, what choices we make and may even have a huge impact on the economy. Suggesting that there may be something wrong with one product may steer people away from that product, at least for a time. It may even scare consumers away from the entire class to which the product belongs. It is very important, therefore, to do one's due diligence before saying something from a platform that reaches audiences in the hundreds of thousands. It's easy to make an error when speaking extemporaneously; we're all human, after all. But when a person's words and presentation are planned well in advance, when there is forethought, and when the topic has the potential to sway a lot of people, that person must tread carefully, dot all their "i"s and cross all their "t"s. It is disturbing when people in such public positions fail in this.

People like Dr. Oz.

Boy Meets Juice

Yesterday, September 14, 2011, Dr. Oz's show warned parents about potentially unsafe levels of arsenic in their children's apple juice.

"Some of the best known brands in America have arsenic in their apple juice." - Dr. Oz

He cited the EPA's limit of 10 ppb in drinking water and noted that the lab used by the show, EMSL Analytical, Inc., found some samples with levels higher than the EPA's limit, with one sample even being reported as high as 36 ppb, more than three times what is allowed in drinking water:

Of these [3 dozen samples from 5 brands], 10 samples came back higher than the arsenic limit allowed in drinking water.

Note: Lab results standard deviation is +/- 20%

Minute Maid Apple Juice

Lowest Sample for Arsenic: 2 parts per billion
Highest Sample for Arsenic: 3 parts per billion

Apple and Eve Apple Juice

Lowest Sample for Arsenic: 3 parts per billion
Highest Sample for Arsenic: 11 parts per billion

Mott’s

Lowest Sample for Arsenic: 4 parts per billion
Highest Sample for Arsenic: 16 parts per billion

Juicy Juice

Lowest Sample for Arsenic: 2 parts per billion
Highest Sample for Arsenic: 22 parts per billion

Gerber

Lowest Sample for Arsenic: 3 parts per billion
Highest Sample for Arsenic: 36 parts per billion

That certainly sounds frightening. I mean, we all know that arsenic is bad. Just look what happened to the poor, lonely men in Arsenic and Old Lace. Or, for an historical perspective on the substance, see how it was used in the early 20th century in The Poisoner's Handbook. In all seriousness, arsenic is a dangerous substance in sufficient doses. It can be fatal if a large enough dose, but even at non-fatal levels it can cause cancer in various organs.

But is Dr. Oz perhaps overstating the threat? Might he be indulging in a little bit of fear-mongering to drive viewer interest and ratings?

It's a Little Complicated

Let's learn a little bit more about arsenic together. According to the FDA, which governs our nation's food safety, the story is a bit more complex than just talking about total levels of arsenic. As they state in their letters to the Dr. Oz Show, there are two general types of arsenic: organic and inorganic. Organic arsenic compounds are generally considered non-toxic in humans. It is also known that for some animals, arsenic is an essential nutrient at low levels, though similar data for humans is, as yet, unknown. In contrast, the inorganic form of arsenic is what causes all the trouble.

According to studies by the EPA, humans can be exposed to 0.009 mg/L-day with no adverse effects. This converts to about 0.0008 mg/kg-day. The lowest level that we start to see toxic effects at about 0.017 mg/L, or 0.014 mg/kg-day. That means that an average 35 lb 4-year-old (~15.9 kg) can be exposed to 0.013 mg of inorganic arsenic each day without toxic effects. Or, to put that into parts per billion, 1.3 ppb. Effects ~~will start to be seen at~~ cannot be detected at all until about 22.3 ppb (0.014 mg/kg-day x 15.9 kg = 0.2226 mg/kg-day) of daily inorganic mercury exposure. At much higher levels, bad things begin to happen.

Now, the problem with Dr. Oz's analysis is that it looked at total (i.e., organic and inorganic) arsenic levels in apple juice, when the type of arsenic most commonly found in apple juice is organic arsenic. He did not discuss the differences on his show, nor on his web site (as of 9/15/11). This confounding of different compounds is similar to the anti-vaccine movements confounding ethylmercury and methylmercury. He also relied on test results from only one lab, which differed greatly from the testing by the FDA and by juice manufacturers. Rather than going to a different lab for re-testing, he went back to the same lab.

And Then There's the Guilt

The ultimate result was that his show made people afraid. In a clip from the show on an ABC News report, one parent on the show even stated, as a result of Oz's rhetoric:

I'm the guy administering poison to my own children.

It was even reported that some schools were removing apple juice from their lunches in response to his apple juice episode.

In defense of his show, Dr. Oz appeared on ABC News essentially taking the "I'm just asking questions" approach. To be fair, he did say that he gives apple juice to his kids and has posted links to the FDA letters on his web site, but he did not take responsibility for instilling unwarranted fear in parents like the man who showed extreme guilt about "poisoning" his kids, nor for providing inaccurate and incomplete information.

Instead of taking a measured approach and providing all of the facts necessary to properly and responsibly inform his audience, Dr. Oz chose to run with one set of test results that are essentially meaningless when it comes to determining the safety of apple juice products. He went for spin and fear, rather than reality. Dr. Oz, you have a huge audience, and they deserve far, far better than the dreck you serve.

UPDATE: Dr. Besser has reportedly been invited to appear on Dr. Oz's show to continue discussing the topic. He has agreed and is eager to talk about it, but wants to broaden the discussion. I hope that he continues to espouse the rational, pull-no-punches approach he took with Dr. Oz in the clip linked above.

It also looks like Steve Novella has discussed this issue over at NeuroLogica, making many of the same points I did. PZ Myers has also commented on Dr. Oz over at Pharyngula.

A Tribute to Ray Minnick (1950-2011) by René Najera

2011-09-14T21:39:00.000-04:00

Some things cannot be kept silent. When we have a moving experience, sometimes we just need to tell people about it. It may be something exhilarating that takes us to the heights of joy; it may be something devastating moving us to profound grief.

My friend, René Najera, has had both of those recently. He has been approved to take the oath of citizenship in just a short time, and he has learned of the passing of a close friend and teacher. Since he was forced to take down his blog, I offered up Harpocrates Speaks to let his voice be heard. Here is his touching personal tribute to Ray Minnick, who passed away September 13, 2011:

I graduated from college as a medical technologist in the Spring of 2000. Unlike other college graduates, my prospects for a job were very good. The number of medical technology (laboratory medicine) programs had dwindled since the 1990s, so the demand was high for lab techs like myself. I had always wanted to live and work on the East Coast, so I put out a lot of applications to a lot of hospitals all up and down the eastern seaboard. One interview after another, I was rejected over and over because I was young, single, and had never been to the East Coast. I had no real "roots" there, so a lot of employers were hesitant to hire someone who could leave at any moment. (They actually told me so a few of the times.)

One place I didn't apply to was the Waynesboro Hospital in Waynesboro, Pennsylvania. Waynesboro is a small town in the Blue Ridge mountains of Southern Pennsylvania. It is two hours from DC and Baltimore and three hours from Philadelphia and Pittsburgh. One morning, at around 7am Mountain Time, I got a phone call from Ray Minnick, the lab manager at Waynesboro Hospital. We talked for a bit about my experience as a student, about my plans for the future (which were few since I just wanted to work and make money), and my plan for moving to the East Coast. It wasn't a particularly memorable phone call. It was rather routine. My hopes to get a job there were few.

Two weeks later, I received a phone call from a person in human resources at Waynesboro. He called to make arrangements for me to travel to Waynesboro and interview in person. Apparently, Ray had nothing but good things to say. I was rather stunned because all he really had was what I posted on Monster.com about wanting a job as a lab tech on the East Coast. That's how he found me. He had gone online and seen my profile and very short resume and still offered me the chance to join him and his team of lab techs in Waynesboro.

I took the chance and traveled to Waynesboro over a long weekend in June. Ray picked me up at the hotel on a Friday and showed me around town before we went to his office. Aside from all the regular questions about the job, Ray asked me one question: "If you see that all the tubes of blood draw on a woman in the OR, who is undergoing a C-section, are hemolyzed, and the repeat draws are hemolyzed, what would you do?"

Without hesitation, I told him I would get the fresh frozen plasma thawing and do a type and screen (blood banking procedure) on her since she was in the process of DIC (diffused intravascular coagulation), a deadly condition in which all of the body's clotting factors are being depleted due to clots being formed everywhere. He leaned back in his chair for a few moments and then came forward, stretching out his hand to shake mine. "The job is yours if you want it." I did. We spent Saturday and Sunday morning finding me an apartment in Waynesboro and showing me the points of interest.

Over the next 7 years, Ray Minnick was the lab manager under whom I worked as a medical technologist. He allowed me a lot of freedom in the job, and he trusted me immensely. He told me so himself. He said he wouldn't have left me working by myself on the third shift if he didn't trust me. I considered that an enormous honor. When I needed help because there was a surgery that had turned bad, or there was a mass trauma event (bad car accident), Ray would show up in his dark blue scrubs and get to work. He was very, very experienced in blood bank. What took me 30 minutes to do took him 20, and he had a sharp mind.

His interactions with me did not stop at the lab. He had me over for dinner a few times, introducing me to his family. He loaned me his truck to move my furniture when I moved into a tiny apartment. He even counseled me when I had a very bad break up with a very serious girlfriend. Heck, even with the not-so-serious girlfriends, he always had a word of advice. There was a particularly "annoying" girlfriend who worked in the emergency department. It was always on and off with her, and the games we played were many. Ray once sat me down in his office and warned me that such a romance at work would not end well.

I wish I would have listened because that nutty relationship really did not end well.

There were also the times when we disagreed on something. There were times when the old Navy Vet in him came out and made me stand at attention as he paced back and forth explaining to me why I was in the wrong... And I didn't have the right of reply. I understood completely that all those things he did and said were for my own good. He really did help me along in the maturation process.

Perhaps the biggest contribution he made to my life was when he walked up to human resources and demanded that the hospital reimburse me for some of the classes I took as I worked toward my Master of Public Health in Epidemiology. Nurses got almost all of their tuition reimbursed, so why not reimburse the "lab boy"? HR argued that I would bolt from there as soon as I got my degree, but he countered that nurses also left once they got their advanced degrees. After a lot of arguing, Ray convinced them to help me financially in getting my MPH. Not only that, but he allowed me to do my coursework during my shifts. I was able to work full-time and go to school part-time and not have to worry about not giving my all to one or the other.

Again, it was a privilege to work for that man.

Unfortunately, Ray's approach to common problems rubbed people "upstairs" the wrong way, so he had enough of the politics and the second-guessing of all his projects for the lab. He came in after hours to talk to me about him having submitted his resignation. He asked me if I felt like he was abandoning me since - in all honesty - he was the one lifeline I had in Waynesboro; my parents were thousands of miles away. I told him he didn't because he taught me well. His parting words to me at the lab were that he hoped to once be the mentor of a "doctor" (meaning my aspirations for a doctoral degree once I got my MPH).

After he left the lab, we stayed in touch by phone and in person once in a while. Just last week, he called me to chat about stuff. He asked how married life was treating me. (He'd been to my wedding one year before.) And we joked about all the fretting I did back then over girls that didn't really deserve so much time and effort. He told me to take care and call him once in a while. I said I would.

Yesterday, as I sat in the immigration officer's office, I noticed that the officer had a lot of memorabilia from the Army. I asked him if he was in the service. He went into a long-winded tale of his days in the Army in Vietnam. This made me at ease during the citizenship interview and exam since Ray had been to Vietnam as well. Their stories were similar, and they were about the same age. For all intents and purposes, Ray Minnick might as well have been the one administering the test to me, a test that I passed. That in itself reminded me of how proud Ray was of me when I seriously considered joining the armed forces after September 11, 2001. He told me that the attacks were a watershed moment in my life like the JFK assassination was in his. But he discouraged me from joining because he said that the country was not in mortal danger and I'd contribute more if I went to school and bettered myself... And got my citizenship. The agent who interviewed me yesterday asked if I'd be willing to "help out" if the country ever needed me, too.

Funny how things parallel each other like that.

Ray Minnick passed away last night at the age of 61. The world lost a great father, friend, medical technologist, and, for me, an awesome mentor. At a time when I was maturing personally and professionally, he was there to set me straight... And teach me how to do a type and screen in record time. He will be missed.

You Can Manipulate a Back, but You Can't Manipulate Reality

2011-09-14T09:29:00.001-04:00

On Twitter, I like to try to keep my followers informed of outbreaks of diseases like measles and pertussis. Some may need to get up to date on boosters for themselves or their children. Some may not be able to receive a vaccine due to a medical condition and so need to take precautions if they are in an area affected by an outbreak. To help me in this, I have some alerts set up to forward news articles to me. For the most part, they are sane, reality-based articles discussing the diseases or the vaccines without spin. Occasionally, something like this article comes along.

Titled "Effectiveness of vaccines needs to be re-examined," it is an opinion piece, so I shouldn't really expect it to be as rigorous as an actual news story should be. However, I would, at the very least, like to see some measure of scholarship, especially considering the author, Ammitai Worob, has at least a college level education (degree in psychology from Hunter College, according to his bio). Why do I say this? Because he trots out a good number of anti-vaccine talking points that have been trounced numerous times over the years.

He begins by asking what seems a reasonable question:

The first question, and one that has become taboo to even ask, is whether childhood vaccines are actually effective.

Now, in the science-based community, merely asking this question is not taboo. It is perfectly fine to ask this question, and it is doubly important to ask it of brand new vaccines. Where he goes awry is this:

The Journal of the American Medical Association published a study in 1998 noting that pertussis was common in the vaccinated population. Shouldn't an effective vaccine prevent contraction of the disease? If parents are to relinquish health care choices for their families, effectiveness must be clearly established even before we discuss safety.

First, it would be nice if he actually provided the title of the study to which he's referring so we can look it up ourselves, especially to find out just how "common" it was in 1998. Perhaps, though, he should have referred to more recent information on efficacy, like the CDC Pink Book chapter on pertussis (PDF), which lists the currently licensed vaccines as about 80%-85% effective. Or, he might have referred to a 2011 Cochrane review, "Acellular vaccines for preventing whooping cough in children," which found that multi-component pertussis vaccines were about "84% to 85% in preventing typical whooping cough, and from 71% to 78% in preventing mild pertussis disease." He should also have avoided invoking the Nirvana fallacy, presenting the false dichotomy of "either it's effective or it isn't," instead of the more rational and logical conclusion that for the most part, the vaccine is effective.

What about other common tropes among ill-informed anti-vaccine screeds? Pharma Shill gambit? Check. Calling for unethical studies? Yep:

Most vaccine studies compare adverse events of children vaccinated with a previously approved vaccine versus those exposed to the newer vaccine. There is no control group of unvaccinated children to compare against. All this tells us is which vaccine has a higher or more varied incidence of adverse events.

Dr. Worob (more on the "Dr." title below), when a company develops a new medical product for the treatment of a disease or condition for which there is already an approved, safe and effective treatment available, a clinical trial comparing the new product against placebo is a no-no. The reason is the ethical concept of justice or equitable share of burdens and benefits. Now, if a company makes a vaccines for a disease for which there are no alternatives, then, as occurred with rotavirus and HPV vaccines, use of a placebo control is not only acceptable but vitally important. I am just a lay person. Certainly, someone who completed a full course in a scientific discipline should know the basics of study design and ethics.

He also trots out the "too many, too soon" nonsense and the aluminum portion of the toxin gambit. And of course he plugs Dr. Robert Sears' (though he says "Dr. William Sears") alternate vaccination schedule, which, as everyone knows is based on a close and careful evaluation of the scientific evidence to ensure that the schedule is both safe and does not reduce the effectiveness of vaccination. Or, wait. That's the CDC/AAP recommended schedule. Dr. Sears' schedule is based on hunches and opinions.

Finally, Dr. Worob brings up the Vaccine Court, which has, rightfully, paid damages to claimants who suffered rare injuries following vaccination. Like many anti-vaccine advocates, he asserts that vaccine manufacturers cannot be sued at all, ever, if a patient suffers injury. However, that is not the case, as reading and actually comprehending the Supreme Court decision (PDF) earlier this year would reveal. Basically, a claim for "design defects" must go through the Vaccine Court first, rather than going directly to a tort claim against the manufacturer in the regular courts. That said, the ruling of the Vaccine Court can be rejected by the petitioner and a tort claim can then be filed against the company, where they must prove not only that the vaccine caused the injury (which, for some injuries, is assumed under the VICP system), but also that the fault lay with the company.

With the level of misinformation and ignorance shown in Dr. Worob's post, I certainly hope the clients of his chiropractic practice go elsewhere for their medical advice, at least on the topic of immunization. As one commenter said:

Chiropractors are trained in manipulating the back. From reading this article, some chiropractors are also good at manipulating the facts.

Experimental Logic

2011-09-05T11:48:00.004-04:00

Every day, thousands of people in the United States take part in clinical trials. These studies look at all manner of things, from the effects of subtle variations in how a broken bone is plastered to psychological studies to studies evaluating new drugs or medical devices. Some studies simply look at healthy volunteers, trying to figure out the normal workings of the human body. Others want volunteers with specific conditions, hoping to understand the progression of a disease or working toward better treatments and outcomes for patients. Still others seek some blend of both healthy and patient subjects. They are conducted by curious, compassionate physicians with grants from the National Institutes of Health, by patient advocacy groups funded by donations and by both small and large pharmaceutical and biotech companies. There is a drive to learn more, to improve the health and well-being of people around the world. Sometimes the hoped for outcomes have very significant meaning, such as working toward a cure for a rare or severe disease. Sometimes they merely contribute to our own vanity, as with a new variation on Viagra or some manner of anti-aging drug. Suffice to say, there is a lot of research going on out there. And just one small area, one that I find very interesting, is research into vaccines: expanding our knowledge of how they work, how to make current vaccines even safer or more effective than they already are and developing new vaccines.

It was with great interest that I discovered I had a new follower on Twitter going by the moniker @EVaccines, or ExperimentalVaccines. This person bills their web site and Twitter account as providing "information on Current and Ongoing Clinical Trails (sic) on Vaccine Research and there (sic) side effects."

Cool! I thought. Here is someone who is providing information on current and ongoing trials on vaccines. This could be some very good, very useful, information! Would this be sort of an easier to navigate version of ClinicalTrials.gov tailored to vaccines? Perhaps there would be links to the various labs conducting vaccine research for those who are interested either in the study outcomes or specific projects under way, or for those who may actually be interested in volunteering to advance vaccine knowledge.

So, I clicked on the link for their web site.

Wow. It was like nothing I expected it to be. There wasn't actually any valid information on current or ongoing vaccine research. Instead, I found a fair bit of conspiracy theory. For example, there is a video purporting to show how Bill Gates is trying to reduce populations, suggesting that vaccines cause sterility in men. The video shows numerous clips of Mr. Gates talking about how improved health care and a reduction of disease burden leads to a decrease in the need for having lots of children. The words "Vaccines reduce populations!" appear repeatedly. In the close of the video, the author of the post states:

It appears as though Bill Gates has definitely been exposed as a tool if anything. We're not sure whether or not he's telling us secrets here or revealing insights into how the so-called New World Order works, because this is no longer a covert operation. It's completely overt, in your face, right in front of you. All you gotta do is put on the right colored goggles, and those are your New World Order goggles.

This does not bode well for delving further into the site. Yet delve I did. I found another post, entitled Experimental HIV Study Trials Infect Volunteers. In this video, @EVaccines completely misinterprets a study listed on ClinicalTrials.gov. The study, A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials was an observational study of individuals who participated in an HIV vaccine study or an HIV vaccine preparedness study (i.e., a study looking at the feasibility of studying a given population for the HIV vaccine, such as Are US populations appropriate for trials of human immunodeficiency virus vaccine? The HIVNET Vaccine Preparedness Study) and who, subsequent to enrollment, contracted HIV. @EVaccines takes this to mean that participation in an HIV vaccine study causes HIV infection. He apparently did not bother reading the description of the study (emphasis mine):

It is important to study persons vaccinated with candidate HIV-1 vaccines who have become HIV-1 infected for the following reasons. First, if transient HIV-1 infection is detected and then is effectively suppressed or cleared, it will be important to document the antigenic relationship between the breakthrough virus and the vaccine epitopes to attempt to answer questions about the specificity and breadth of the immune response and the determinants of immunity. A second reason is to gain a better understanding of vaccine-induced responses in those participants who are transiently or persistently HIV-1-infected compared to placebo recipients who become HIV-1-infected. If the vaccine does not prevent HIV-1 infection, it will be important to characterize the course of the disease as measured by longitudinal viral load measurements, CD4+ counts, and clinical symptoms. Understanding the breadth, magnitude, and specificity of the immune response in partially or fully immunized vaccinees after infection and the impact on clinical symptoms and disease progression can potentially result in valuable information for the subsequent design of vaccine efficacy trials and, ultimately, in consideration of potential effectiveness of HIV-1 vaccines.

The author compared this to another study titled Candidate HIV Vaccine. This study examined a vaccine candidate that "contains no live HIV virus or CMV and cannot cause either of these illnesses." He suggests that the first study found individuals infected by a vaccine and that the latter study lied about the risk. What he perhaps failed to grasp is that people who participated in a vaccine study and were subsequently infected with HIV were most likely infected because the vaccine simply did not work. Because it was not effective, they were still at risk for contracting the disease. And the latter study did not lie. If a vaccine does not contain "live" virus, but only synthetic virus bits and pieces, there is no physical way that it can actually cause an infection.

@EVaccines closes his HIV video with a patent for a supposed AIDS cure, because patents, as we all know, are wonderfully sound, scientific evidence that something both works and is safe (a search for the patented product on PubMed turned up nothing). He also buys into the "U.S. government engineered HIV" nonsense, concluding by saying that our government is "experimenting on everyone." In fact, he hits this topic in at least three separate posts.

It appears that this guy approaches the topic of vaccines with the preconceived notion that there is, in fact, a great conspiracy going on. He pretty well says as much in his About page (emphasis added):

No logical fallacies only plain text truth with some visuals to shock the mind. We live in the most experimental & controlled society in human history. Bio weapons are being tested on the public! Please if you disagree show me where I’m wrong.

Apparently, if a study is listed on ClinicalTrials.gov, it's because it is a government experiment, rather than because the law requires registration of all studies involving a new drug or device, not to mention that many scientific journals are now requiring studies to be registered there if the researchers want their study to even be considered for publication. It appears that @EVaccines believes that these clinical trials (he seems to love the word "experiment" because it sounds all evil) are being conducted on the unsuspecting public against our will, despite the fact that rather strict laws are in place to ensure the ethical and voluntary participation of individuals. Though he states that there are no logical fallacies, he engages in begging the question, argument from ignorance, the fallacy of the single cause, the fallacy of quoting out of context and the mind projection fallacy, among others.

I have to say, when I first saw the description of @EVaccines' site, I was excited. I really hoped that it would provide useful information about clinical trials. Instead, all I found was conspiracy theory, false assumptions and experiments in distorted logic.

UPDATE: As of the morning of Sept. 6, @EVaccines has changed their Twitter profile to read:

EVACCINES aka EXPERIMENTALVACCINES asks the Question? VACCINES SAFE? Yes or NO VACCINES BIO-WEAPONS? Yes or NO WE PROVIDE VACCINE EXEMPTION FORMS & INFO

Measles in Refugee Center

2011-09-02T18:06:00.001-04:00

The Montgomery County Health Department issued a press release September 2, 2011 alerting the public to two confirmed cases of measles. The index cases were two unvaccinated children who arrived in the U.S. on August 24. On Monday, August 29, they visited the Suburban Washington Resettlement Center, the Washington, D.C., branch office of the International Rescue Committee (IRC), located at 8700 Georgia Avenue, Silver Spring, MD. The IRC is an organization that helps refugees who have been invited by the U.S. to seek asylum here, helping them to get settled and rebuild their lives.

As Gazette.net reports, as part of its routine work, the center gives all incoming clients a health exam. It was during this exam that the measles virus was identified in the two children, however the children did not yet show signs of the disease. Since it is very likely that they were contagious at the time of their visit to the center, the health department says that anyone else who visited the building on the 29th "should be aware that they may have been exposed to measles."

Another aspect of this, and one that I have not seen reported in the few news articles covering the story thus far, is that the children were likely contagious over the period when hurricane Irene hit Maryland. As the children were refugees, they likely needed to go to a public shelter during the storm. If that did happen, that would expand the pool of potential contacts. However, this is speculation and should not be cause for alarm at this stage.

The other aspect to consider is that many of the individuals who visited the resettlement center on Monday were also likely refugees. The implications of this are that there may have been a large number of individuals who were from regions with poor health care infrastructure and potentially lower immunization rates. That means a greater risk of infection, and it is probably that we will see a large number of subsequent cases stemming from this incident.

Prior to these two cases, Maryland reported possible measles exposure between May 31 and June 3, as well as another case in July (PDF).

As with the latest outbreak in Minnesota, I will try to keep tabs on how this develops. Anyone who reads this and was possibly exposed or knows someone who may have been, I would urge you to be vigilant for any symptoms of measles and to contact your physician for advice on how to proceed. Measles often starts with cold-like symptoms: cough, watery eyes, runny nose and fever. This is followed by the appearance of a rash on the head and face, which gradually spreads down across the body to the arms, legs, hands and feet. If you think you may have been infected, it is important to contact the doctor's office before going there to reduce the chances of infecting others.

UPDATE: Post-exposure prophylaxis for measles involves administration of immune globulin (IG) to prevent infection. A friend of mine in the public health sector informed me that the dose required for prophylaxis following exposure to the measles virus is about .25mL of IG per kilogram, up to a maximum of 15mL. One 10mL vial of IG is about $200. The cost to treat all of the people exposed to a single case and who have unknown, incomplete or no immunity can run upward of $33,000.

Third Case Identified in Latest Measles Outbreak in Minnesota

2011-08-26T15:00:00.000-04:00

A brief post to provide an update on the latest measles outbreak in Minnesota. On August 26, 2011, the Minnesota Department of Health announced that a third case has been identified. The latest is a 43-year-old woman who was exposed to the index case in a health care setting. She had unknown vaccination status and was identified through follow-up of people who had been exposed to the two initial cases.

As of this writing, the 12-month-old child, who had contracted the illness while in Kenya, is still in critical condition, but the second case, the 15-month-old, has been released from the hospital. Neither of the children had been vaccinated against measles.
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Related Posts:
New Measles Cases in Minnesota
Minnesota Measles Outbreak - A Recap
Acute Thrombocytopenic Purpura, the MMR and Natural Infection
"Soft" Hospitalizations in Minnesota Measles Outbreak?
Minnesota Measles Outbreak by the Numbers: A Timeline
Measles Outbreak in New South Wales, Australia
Climbing Numbers in Minnesota Measles Outbreak
More Cases of Measles in Minnesota, 3 of 4 Hospitalized
Minnesota Infant Contracts Measles - Why Immunization Is Important
Measles Outbreak in Boston

A Brief Note on Legal Thuggery and the Silencing of Others

2011-08-24T12:15:00.001-04:00

A friend of mine, we'll call him Mr. T, was recently the target of the negative attentions of a bully, we'll call him Mr. BS. You see, Mr. BS said some defamatory things about some people on twitter. Mr. T didn't take kindly to it (after all, he pities the fool that bullies others) and called Mr. BS on it, going so far as to write up a blog post, stating facts about the exchange, as well as some additional information about Mr. BS. This ruffled Mr. BS's feathers, but rather than doing what a normal person would do and contacting Mr. T privately to work out the disagreement, Mr. BS published Mr. T's work address, phone and e-mail address on Twitter and in the comments of a news article, as well as blast e-mailing just about everyone at Mr. T's place of employment, threatening law suits if Mr. T didn't back down.

Imagine for a moment a purveyor of health and science information. The don that controls things on his street comes by and tells him to pay up or he's gonna break some kneecaps. In the situation with Mr. T, the "payment" is to cease all use of social media on topics of public health and instead of breaking kneecaps, he stands to lose his job. Why such a strong reaction? Because Mr. T's overseers viewed Mr. BS's sabre rattling as enough of a nuisance that they just wanted to avoid any legal issues altogether, thinking Mr. BS more of a tiger, when in reality he's closer to a gnat.

This whole deal, if you haven't guessed by now, is #EpiGate. I've been debating whether or not to write about this for a while. Normally, I would have been all over this issue from the beginning, but a few things gave me pause. First, I didn't want to do something that would make things worse for Mr. T's work situation. He's a good guy. I like him. He's a tremendous educator and advocate for public health. It's bad enough that the muckymucks at his place of employment put the kibosh on his online activities, I didn't want to do something that would risk him losing his job altogether. Second, at first I was nervous of what Mr. BS might try, since he has also rattled his sabre in my direction, though I've yet to do anything that would give him any legal claims whatsoever. Primarily, I was concerned that he might try to find out who I am and blast e-mail others connected with me. After talking it over with some others and taking a look at applicable laws in my location, I find that I have some good support, so my worries have been largely quelled.

At any rate, I'm not going to dwell on things. I just wanted to let people know why I've been quiet on this and just voice my feelings about how I think Mr. T's employer is, quite frankly, doing exactly the wrong thing. They should support and laud him for what he does to progress public health and educate others. A lot of other people have already said much of what I would have said on the issue, and Liz Ditz, as always, has the round-up of other posts. I strongly encourage my readers to start with her post; specifically, read the comments in which this person outs himself for an indication of his character.

Should anyone feel like commenting here, I have a few rules:

No name-calling.
No swearing.
No publishing personally identifiable information or contact info of others.
Please DO NOT contact my friend's employer, as it would only make matters worse for him.
No linking to Google caches of any deleted blog posts, etc. If you want to find these things, you can search for yourself.
Try to avoid making statements that are untrue and may be grounds for a libel case, even if only in the fevered imaginings of the deranged. I would hate for my readers to be drawn into litigation with Mr. BS, even on meritless claims, and I would prefer not to have myself or my blog drawn into any litigation. Please do not make me regret writing about this issue.

Any comments which violate these rules will be removed. Because of Mr. BS's nature as exhibited on just about every post covering #EpiGate, I am taking measures which I am loathe to enact, since I value free speech very highly. However, I can also understand what a determined individual can do if they are intent on silencing others through the use of things like SLAPP suits. I also encourage people to keep these rules in mind when commenting on other sites.

Finally, if Mr. BS happens to read this, let me simply say that anything I have written is my opinion and mine alone. I do not represent myself as an agent of any other person or organization. Just as I am respecting you by not contacting people or organizations connected with you, I request the same. I believe it best for all involved that you let the matter drop, since persisting with the subject is only having the effect of generating more and more posts about it and ultimately tanks your image even more. Further, I do not believe that any of my comments in this post have been defamatory; if you feel otherwise, please state which specific statements of mine you think are defamatory and the reason and I will review what I have said.

Thank you all, and Mr. T, I hope the individuals responsible for gagging you read all of the supportive comments that have been written and come to realize the errors of their ways.

New Measles Cases in Minnesota

2011-08-19T16:07:00.001-04:00

The Minnesota Department of Health reported on August 19, 2011 that there are two new cases of measles in that state. The index case is a 12-month-old infant who was infected while on a trip to Kenya. The second case is a 15-month-old child who acquired the measles virus after exposure to the first infant. Neither child, both residents of Dakota County, had been vaccinated against the disease. Both children have been hospitalized. The Shakopee Valley News and the Columbus, IN paper The Republic, as well as news station KARE11, report that the 12-month-old child is in critical condition. These cases are not connected with the measles outbreak in Hennepin County earlier this year, which resulted in 21 cases, almost all unvaccinated, with 14 hospitalizations.

Although both children were unvaccinated, it should be noted that they are right around the age when the first dose of MMR is recommended, according to the CDC schedule (PDF). Sources do not report any reason for the infants being unimmunized; it may be that the parents simply had not scheduled the appointment yet. It is also possible that the parents had avoided the MMR due to misinformation promulgated over the past several years in Minnesota by anti-vaccine activists which has negatively impacted herd immunity.

I will try to keep an eye on this situation, in case any further cases arise.

UPDATE: The 12-month old who has been hospitalized since August 10 appears to finally be recovering. Measles left Mahi Abdallah susceptible to a secondary pneumonia infection that very nearly killed him. He has been cared for in the pediatric ICU at Children's Hospital in Minneapolis. His mother, Nuria Koto, had planned to have him vaccinated against measles, but he was only 9 months old when the family left to visit Kenya. She thought he was too young to receive the MMR (typically recommended to first be given at 12 months) and was unaware of travel recommendations that allow for administration of the vaccine as young as 6 months old. I urge those considering whether or not to delay vaccinating against MMR to read his story. No parent should have to go through this, and my heart goes out to Nuria, Mahi and the rest of their family.
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Related Posts:
Minnesota Measles Outbreak - A Recap
Acute Thrombocytopenic Purpura, the MMR and Natural Infection
"Soft" Hospitalizations in Minnesota Measles Outbreak?
Minnesota Measles Outbreak by the Numbers: A Timeline
Measles Outbreak in New South Wales, Australia
Climbing Numbers in Minnesota Measles Outbreak
More Cases of Measles in Minnesota, 3 of 4 Hospitalized
Minnesota Infant Contracts Measles - Why Immunization Is Important
Measles Outbreak in Boston

Deception in Research

2011-08-18T07:00:00.004-04:00

When is it okay to lie in a study? When someone volunteers to be a research subject, whether it is a psychological study or clinical trial for a new drug, a corporate study or student project, what are the limits on just how much you can deceive the person? What aspects of the deception should be disclosed, and which are okay to keep hidden from the subject? If you do disclose the deception, do you need to be up front about it? Can you wait until after the study is under way or even completed?

The easy answer is that researchers shouldn't lie or mislead study subjects. Lying is wrong, right? Besides, lying could have a very big impact on whether or not the subject participates. And then there are the psychological impacts of being lied to. Just look at the famous (infamous) Shocking Experiment by Stanley Milgram. Most people learn about this in high school social studies, but for those who may be a bit fuzzy or haven't heard about it, a quick summary.

Milgram enrolled volunteers (teachers) in a study, telling them that they were going to read a series of word pairs to other study subject (the learner) and then read one word and four possible matches, delivering a shock if the subject responded with the incorrect match. The teachers and learner met before the experiment began and engaged in small talk, forming a friendly acquaintance. What Milgram did not tell his volunteers was that the learner was just an actor who never received any shocks and that the responses they heard were prerecorded; the volunteers were the ones really being studied to see how far they would go, how strong of a shock they would deliver, in deference to authority.

At the end of the experiment, with a majority of subjects having delivered quite high shocks, and some even going to the maximum, the truth was revealed. During the study, many of the subjects became quite agitated and stressed. The potential for serious psychological harm, as well as stress-related physiological effects, was present, though all subjects were debriefed afterward. An analysis of the study can be read here. Suffice to say, Milgram's experiment would almost certainly not be approved today. It is often held up as an example of just why research ethics and straight-dealing with subjects is so important, and to illustrate the risks of deception in research.

But the questions I asked are not quite so easily answered. There are times when deception is not just okay, but required in order for the study to provide accurate, meaningful results. Taking a little autonomy away from the subject is sometimes required.

The Randomized, Blinded, Controlled Study

Probably the most common and accepted form of deception in research is when subjects are randomly assigned to receive either the experimental condition (activity/procedure/drug/device being studied) or the control condition (comparative item/procedure or placebo), but during the course of the study, they will not be informed of which condition they received. In other words, they are blinded to the condition, the deception being that key information is withheld from them. The epitome is the placebo-controlled trial. Deception of this nature is vital for a great deal of research, since the opposite (open-label or unblinded) design would allow for the subject to respond differently, based on which condition they know they are in. In a drug study, if the subject knows whether they are receiving the study drug or a placebo, they may react or behave differently, report greater improvement or more side effects if they know they are getting the drug than if they know they are getting the placebo. Blinding the subject to this helps to reduce or even eliminate that kind of bias, which can render the study results meaningless.

In order for this kind of deception to be approved by an ethics committee, though, the subjects must be told up front that the deception will be occurring and the nature of the deception. The informed consent process must disclose that there will be some drug/etc. other than the experimental drug and that they will not be told which they are receiving. They must also be told the nature of the other drug (active comparator, placebo and so on). In other words, the researchers need to say, "Look, we're going to be lying to you. This is the specific part of the experiment that we are lying about, and this is the nature of the lie. All the rest of the study is on the up and up."

This kind of deceit has little risk for the subject. The information withheld is unlikely to have any significant effect on their psychological well-being and, having been informed the range of possible conditions they may receive, they have enough information to make an informed choice about whether or not to participate.

Other Forms of Deceit

What happens with other forms of deception? Suppose the true purpose of the study is not disclosed (e.g., the Milgram study above, or when subjects are only told that their performance on a quiz is being tested, when the true purpose is to gauge the effects of distractions on performance), is that ethical? Or what about if subjects are told that X is going to happen, but the researchers never intended on delivering X or had always planned to give Y instead?

One of the big problems that needs to be considered when deciding whether or not these forms of deception are ethical in human research is whether it affects the subjects willingness to participate or to keep participating in the research. If the information that is being withheld would affect their decision, then it should be disclosed. Of course, disclosure may jeopardize the validity of the study. In the example of quiz performance and distractions, suppose the distraction that is planned is a very sudden, unexpected and loud noise. For many people, that may not be an issue at all. It gives a bit of a start, but no real harm is done. Now, what about individuals with a panic or anxiety disorder? Or those with a heart condition? For these people, that little bit of information about the purpose of the study and the fact that there would be a startling event is information that could affect their decision whether or not to participate. They know what types of things could trigger or exacerbate their condition, and such an event may be one of those. On the other hand, telling subjects the nature of the study (effects of distraction on performance) or the type of distraction (the loud noise) may subtly influence their behavior, thus invalidating the results of the study. Before I talk about how to address this, let's look at another example.

There was a recent study published in the New England Journal of Medicine by Wechsler, et al., comparing the outcomes of an active drug, one of two placebos or no intervention in the treatment of asthma, titled Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma¹. In this study, researchers gave subjects with stable asthma either an albuterol inhaler, a placebo inhaler, placebo acupuncture (sham acupuncture) or no intervention at all. Each participant received three sessions of each treatment, but did not know whether they were receiving the real deal or a placebo. I won't go into the science or conclusions from this study, since Orac at Respectful Insolence already did so. Instead, I'm going to try to focus solely on the deceptions used and the ethical considerations. In addition to the article linked above, readers may find it useful to refer to the study protocol² (PDF) and Supplementary Appendix³.

So, what specific deceptions were used? First off, we have blinding to the treatments being received. However, what also occurred was deception about the range of treatments to be used. As stated in the protocol, though not in the actual paper, the subjects:

will be informed that they may receive several strengths of active or
placebo bronchodilating medication and active or placebo acupuncture at different times during the study. [emphasis added]

Similarly, the Supplementary Appendix notes that a research assistant:

informed [the study subjects] that they would receive one of the following interventions on that day: an inhaled medicine (active or placebo), acupuncture (genuine or placebo), or observation of natural history. [emphasis added]

Subjects were told that they might receive actual acupuncture instead of sham acupuncture (shamcupuncture?), even though real, skin-piercing, meridian-aligning acupuncture was never going to be used at all. In other words, subjects were led to the false belief that real acupuncture could be administered as a treatment.

After subjects completed participation, researchers gauged whether subjects thought they were receiving real or placebo treatment, finding (from the actual paper):

Treatment credibility was high, and most patients believed that they had received active treatment (73% for double-blind albuterol, 66% for double-blind placebo inhaler, and 85% for sham acupuncture). The two double-blind conditions did not differ significantly from each other, but sham acupuncture was significantly more credible than both inhaler conditions (P<0.05).

Now that we know what actual deceptions were in place and how the researchers measured the effectiveness of the deception, let's consider the ethics involved. Since I already addressed the use of blinding subjects to the treatments, I won't rehash it here. What about the misleading list of possible treatments? None of the available materials state how this misinformation was presented in the informed consent form, but we can guess, since the study was approved by an IRB, that something like authorized deception was used, in which subjects are told in the consent form that deception will be used, but the exact nature of the deception is withheld. Is that all that is required? Should participants be told which treatments were genuine and which were false once the study is over? Neither the article, protocol nor Supplementary Appendix make any mention of whether or not subjects were disabused of the deception when they finished participation or when the study as a whole ended.

In the Archives of Internal Medicine, the National Institutes of Health's Dr. David Wendler uses the conditions for the use of deception in research from the Ethical Principles of Psychologists as a basis for IRB approval of research beyond just psychological studies⁴:

(1) the use of deception is necessary; (2) the use of deception is justified by the study’s social value; (3) subjects are not deceived about aspects of the study that would affect their willingness to participate, including risks and potential benefits; (4) subjects are informed prospectively of the use of deception and consent to its use; and (5) subjects are informed of the nature of the deception at the end of their participation

Wendler's list provides an answer for my question above; the participants should have been debriefed regarding the nature of the deception. But why? What harm would there be in not informing the subjects that there was no real acupuncture, as they were informed by the researchers?

A large number of the subjects (85%) reported that they believed the sham acupuncture was the genuine article. Furthermore, after receiving the sham acupuncture, subjects reported about a 46% improvement in subjective outcomes, just shy of the 50% subjective improvement from albuterol. Therefore, if they are not told otherwise, people who participated in the trial may leave with the belief that acupuncture is effective for treating asthma. Not only that, but because the subjective ratings were quite similar to those for albuterol (the only treatment that demonstrated significant objective improvement), they may believe that acupuncture is as effective as using an inhaler to control their asthma. There is potential, then, for the subjects to opt for acupuncture instead of albuterol to treat their condition, with the result being a worsening of their illness. They may also tell others not involved in the research, spreading this erroneous belief.

Though there may be no direct negative impact on the subject by failing to debrief them upon completion of the study or earlier, we can see that there is potential for harm and, thus, reason to clear things up at the end of the study. But this is not the only possible harm that can come from using deception in a study.

More Unintended Harm

Wendler also notes that there may be further unintended consequences stemming from deceiving study participants. He reminds us that in many clinical studies, especially those involving treatment of a condition, subjects may assume that they can trust the researcher. Doctor-patient relationships are built on trust. Deception holds the potential to undermine that trust. Subjects who respond negatively to being misled in the research context may be less likely to participate in future research and may even come to view doctors in general as untrustworthy. The lie robs the subject of the fundamental ethical principles of autonomy and respect.

What to Do?

There are always going to be situations where deception is unavoidable. Some aspects of research may require lying to study participants in order to generate data that will actually lead to meaningful results that advance our understanding of various conditions and improve the quality of medicine. But there are pitfalls that may affect the participant, the research endeavor or even medicine as a whole.

Informing potential subjects that they will be misinformed about some aspect of the study, i.e., authorized deception, can mitigate some of the negative facets of lying or withholding information about the study. Subjects that are comfortable with being tricked are more likely to participate than those who are not, and they are less likely to suffer harm as a result of the ruse once the study is finished.

But, as illustrated by the Wechsler example, alerting subjects before they agree to be in the study that they will be deceived is no guarantee that the prevarication will not result in some manner of harm. Debriefing subjects as early as feasible (either when their participation ends or when the whole study is finished) is therefore necessary to further minimize the risks to subjects.

We can use the points outlined by Dr. Wendler as a general guide to determining whether or not it is ethically acceptable to use deception in research. Ultimately, though, studies must be judged on a case by case basis. What may be appropriate in one study may not be so for a different study.
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References

(1) Wechsler, M., Kelley, J., Boyd, I., Dutile, S., Marigowda, H., Kirsch, I., Israel, E., & Kaptchuk, T. (2011). Active albuterol or placebo, sham acupuncture, or no intervention in asthma. New Engl J Med, 365, 119-126.
(2) ibid. Active albuterol or placebo, sham acupuncture, or no intervention in asthma - Protocol. New Engl J Med, 365.
(3) ibid. Active albuterol or placebo, sham acupuncture, or no intervention in asthma. New Engl J Med, 365 (Suppl.).
(4) Wendler, D. (2004). Deception in the pursuit of science. Arch Intern Med, 164, 597-600.

Map of Mark Geier Medical Licenses

2011-08-11T18:18:00.020-04:00

UPDATE: I was recently informed that Dr. Geier also has a license in Texas. The map and list have been updated accordingly. He also appears to have a license application pending in Ohio, though the medical board of that state has noted the Maryland action against him and has issued a citation.(Added August 20, 2011)

With all of the various states that have licensed Dr. Mark Geier and the rising tide of suspensions of those license, I thought it may help to provide a map, visualizing which states have suspended Dr. Geier's license to practice medicine and which states still allow him to see and treat patients.

So here we go. Red states are those which have stopped Dr. Geier from misdiagnosing children with precocious puberty and subsequent treatment with the chemical castrator, Lupron, and the green states are those which have yet to take action to bar him from potentially harming any more children.

Mark Geier Medical Licenses by State - Click to Enlarge

I will try to keep this updated as state decisions roll in. For more background on this, you may wish to read the posts below.

To look up the status of Dr. Geier's medical license, clicking on the state names below will take you to the respective licensing board's license look-up page or directly to his listing for that state:

California - Suspended August 3, 2011, Petition to Revoke Filed August 30, 2011
Florida
Hawaii - Will expire Jan. 31, 2012
Illinois
Indiana - Suspended June 23, 2011, Extended August 31, 2011
Kentucky - Will expire Feb. 29, 2012
Maryland - Suspended April 27, 2011; Affirmed May 12, 2011
Missouri - Will expire January 31, 2012
New Jersey - Expired August 5, 2011; Suspended September 15, 2011
Ohio - Pending. Maryland action is noted and citation issued July 13, 2011.
Texas
Virginia - Suspended June 9, 2011
Washington - Suspended May 26, 2011

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Related Posts:

Mark "Castrate 'Em" Geier's License Suspended - Part 5

2011-08-10T16:21:00.003-04:00

Another brief update on the status of Dr. Mark Geier's licenses to practice medicine in various states. It has come to my attention that a fifth state, California, has now suspended Dr. Geier's license to practice in that state, effective August 3, 2011.

This comes following suspensions (in chronological order) in Maryland (PDF), Washington, Virginia and Indiana (PDF). He still has licenses to practice in Florida, Hawaii, Illinois, Kentucky, Missouri and New Jersey, although it has been reported that his license in Illinois is also under review for possible suspension. There have also been rumors that Missouri will follow suit.

Five dominoes have fallen, six remain.
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Related Posts:

A Parent's Story of Vaccine Reaction

2011-08-05T12:00:00.001-04:00

Among the vocal anti-vaccine arm of the autism community, a very common story is that of a parent who brings their child to the pediatrician’s office for their routine shot, and then, BAM!, like a bolt of lightning, the light goes out of their child’s eyes and they regress into autism. Right then and there, the parent decides that no vaccine needle will ever touch their precious, “broken” child, nor indeed any of their children, ever again. Not only that, but they may be so affected by the experience that they encourage other parents to forgo immunizations for any child. At least, that’s how the story goes. More often, the timeline is more gradual, and the emergence of an anti-vaccine perspective slower, building as they read more and more material which plays on their fears and appears to confirm what they suspect: that each and every vaccine on the recommended schedule is nothing but a ticking time bomb waiting to steal children from their parents.

Well, this got me to thinking about those parents whose children had experienced an adverse event following a vaccine. What about those parents who, like many of those on the anti-vaccine side of things, have gone through similar emotions and fears, yet came out following science and reason and chose to continue to support vaccination as a means of protecting both individuals and society. They are not nearly as vocal, so their stories are seldom heard. Certainly, there must be some out there who were willing to tell their tales. Putting out the word that I was looking for these accounts, I received an email from one individual, who had been thinking about telling her story for some time. After careful thought and consideration, she agreed to let her narrative appear on Harpocrates Speaks. Without further ado, here is her story, in her words:

I’m an older mom. Old enough that I’ve got one of those funny round marks on my shoulder from the smallpox vaccine. My husband is a little bit younger, and he doesn’t have one. I have two children, born just over two years apart: an older girl and a younger boy. We live in Southern California.

I am also a PhD chemist. Although it’s not my current career path, I have formerly been employed in pharmaceutical research: drug discovery for both a big corporation and for a small biotech startup, but never involved in vaccine development.

At my daughter’s 4-year physical, her pediatrician and I discussed which vaccines were due. Since at the time the schedule recommended by the AAP called for MMR, Varicella, DTaP and Polio to be given as 4 separate injections between 4 and 5 years old, we decided to go with MMR and Polio right away and DTaP and Varicella the following year.

One year later, at the end of my daughter’s 5-year physical, she underwent a capillary blood draw (I’ve forgotten what it was for; it might have been lead exposure), followed by the DTaP and Varicella vaccines, all done by the nurse after we were done talking to the pediatrician and had been given the Vaccine Information Sheets.

Standard operating procedure for preschooler’s vaccines at the pediatrician’s office in those days was that the child sits on the parent’s lap on the exam bench during the injections. My toddler son was playing with the exam room truck on the floor at the time. Immediately after the injections, as the nurse was returning the syringes to her little tray, my daughter, still sitting on my lap, thrashed – her arm narrowly missing my head — then her eyes rolled back and she became unconscious. I managed to lay her down on the bench without dropping her, and the nurse brought the pediatrician back into the room. A few moments later, my daughter came to, finding both her doctor and her mom hovering over her (I asked her if she knew who was president; I should have been asking who was her favorite Disney Princess).

We followed up with an EEG which was normal.

The Vaccine Information Sheets (I have kept at least one copy for each vaccine my children have received; they’re also available online) lists the risk of seizures following DTaP as 1 in 14,000. Did my daughter suffer a seizure as a reaction to DTaP? It’s hard to say for sure. Was it really a seizure? The pediatrician was out of the room and the nurse had her back turned when it happened, so neither can make that call one way or another. There’s no question that she became unconscious. Did the DTaP actually cause it? Or perhaps the Varicella vaccine, or the capillary blood draw a few minutes earlier, or was it a totally random event? All I know for sure is the timeline (pretty much right after the injections), and that she’d never had that happen before and it hasn’t happened since. So far, the only vaccines my daughter has had since her reaction are flu vaccines - one injected and one inhaled. Nothing out of the ordinary happened.

I spent some time poking around looking for information to help me understand what had happened. I read what I could from the public library and any articles I could access for free online (out of the industry, I no longer had easy access to full journal articles). As my son’s 4-year pediatric appointment approached, I began looking harder, since I knew he was due for that same set of vaccines: Polio, MMR, Varicella and DTaP. I needed to determine whether or not DTaP was safe for my son in light of what happened with his sister.

This is where literature searching failed me. I never found “the one” magical study that would have laid my fears to rest. I found a lot of information, little of it useful. Most studies deal with infants up to 24 months, not 4 or 5 year olds. Family histories have been studied in the context of febrile seizures, but not (as far as I could tell with access only to the abstracts) the kind my child suffered. I wish someone would publish a follow-up on families who have suffered vaccine reactions. I’d like to know if there is a genetic component to adverse events, or if it’s just random chance. Or (more likely) which ones are column A and which are column B. But I’m not even sure whom to contact to suggest such a study.

In the end, this is what I was confronted with: my daughter had apparently had a bad reaction to either the DTaP or Varicella vaccine. When I had to decide whether or not to vaccinate my son, there had been over 400 cases of pertussis reported for the state of California for the year. The final number for 2010 totaled 1124 cases, the most in half a century. There were cases reported in our local schools—not the ones my children attend, but in those whose students attend the same activities (i.e., gymnastics classes, Little League, swimming lessons) at the same places as my kids.

How do I make this decision? Risk seizure, or risk pertussis?

The bottom line: I would never have forgiven myself had my son suffered through the “hundred day cough” of pertussis because I was afraid of the vaccine.

I make sure my son holds my hand crossing parking lots because he’s still too little to be seen through a rear view mirror: I protect him from getting run over. How could I not protect him from disease, if I have the chance to protect him?

I’m still not sure what we’ll do when my daughter needs her next booster for tetanus and pertussis. It’s still quite a few years off (eight years, if we go by tetanus numbers). When the time comes, we’ll look at the risks—both for vaccine, specifically for her history, and the risks of encountering the disease. And no matter what we decide to then, I’ll make sure she understands how to assess her own risk—without scaremongering in either direction.

As for my son: how did he react to his 4-year-old vaccines, including DTap? The only reaction he had was that within hours, he complained his leg (the injection site) hurt and kept asking me to carry him around for the rest of the day. And since I’ve had my fair share of tetanus shots, and I’m a bit of a sucker when it comes to my kids, I did.

Looking back, I'd probably go through the same course of action. And I will have to do it all over again when my daughter is due for her next DTaP booster (although by the time it's due it may be TDaP). I'd just like to reiterate that I agree that more research is needed. But it's not the research that the most vocal people are crying out for. What's needed is a retrospective study follow up of cases in the VSD.

Though I have never personally been in this situation with a child, I can understand the fear and uncertainty involved. Not knowing leaves one feeling vulnerable. We want to be able to keep things in control, and when something like this happens, there is often nothing we can do other than mitigate the fallout and do our best to understand. When we are in that moment, when our fears are intensified, the lure of easy answers looms large. Something that lets us feel that we are again in control, that we know the answer, even if that something is false, is very appealing, and once we latch on, we gather those bits that support it, that add to that feeling of control, and ignore anything that disabuses us of our false sense of security.

Going through that, yet avoiding the siren call of false empowerment and pat reassurances, is difficult. My sincere thanks to my reader for sharing her story and for showing that, while bad things can happen, it doesn’t mean that vaccines are irredeemably bad or that you should eschew immunization. Rather, it calls for a rational, reasoned response. When the time comes for the next shot, they will discuss it with their doctor and try to figure out the best course of action based on what is known, and that may lead to actually opting for the shot. There are parents out there who have been through the rare adverse event following a vaccination, yet who still support vaccines as the public health boon that they are. They realize that, while there is still more to learn and always room to improve, the risks presented by vaccines are far outweighed by the risks from the diseases they prevent.

Mary Tocco, Is She Mistaken or Misrepresenting?

2011-08-04T09:32:00.000-04:00

Something that has been noted here and elsewhere over the years is that anti-vaccine activists generally play rather loose and free with facts. They have this tendency to misrepresent reality in a way that suggests support for their opinions, and sometimes they even downright fabricate "facts" that have no basis in the real world. Take the long-debunked claim that vaccines contain anti-freeze. (They don't.) Because their goal is to stir up fears about vaccines, they latch onto scary-sounding chemical names and equate them with all manner of ills. Where nuance is called for, they resort to hyperbole. Their goal is fear, not truth.

Mary Tocco is no exception. I came across an article she wrote August 2 entitled "Seasonal Flu Vaccines, Are They Safe or Necessary?". Other than the poor word choice (I think they are generally safe and necessary in order to protect the greatest portion of the population; are they really only safe or only necessary?), I'll give you one guess as to what she thinks. In true anti-vaccine activist form, she jumps straight into getting things wrong in the very first paragraph:

The seasonal flu vaccine is now recommended every year for every man, woman and child from the age of 2 throughout the rest of life. This mandate is the result of the exaggerated H1N1 Flu pandemic of 2009 that proved to not even be a pandemic. This is a political vaccine with no scientific basis that will make millions for the flu manufactures and cause health problems for thousands. How does a person sift between the conflicting information provided? As a 30+ year independent vaccine researcher, I hope these facts will help you decide if you or your children will receive the seasonal flu vaccine.

First off, the vaccine is not mandated. It is a recommended vaccine. It is an optional vaccine. There is no requirement (i.e., mandate) that everyone age 2 and up receive it. Second, it was recommended before the 2009 H1N1 pandemic. The annual flu vaccine was first recommended for high-risk patients starting in 2002. In 2004, the recommendation was expanded to include healthy children aged 6-23 months. In 2007 it expanded to 6-59 months. The 2009 schedule (published well before the emergence of H1N1 in the U.S.) expanded it to include all children 6 months to 18 years. During that whole period, the flu vaccine was also recommended for healthy individuals who were in close contact with any of the other recommended populations (high-risk or children). The recommendation was clearly not the result of the H1N1 pandemic. And yes, it was a real pandemic. You see, here's the definition that the World Health Organization uses:

Phase 5 is characterized by human-to-human spread of the virus into at least two countries in one WHO region. While most countries will not be affected at this stage, the declaration of Phase 5 is a strong signal that a pandemic is imminent and that the time to finalize the organization, communication, and implementation of the planned mitigation measures is short.

Phase 6, the pandemic phase, is characterized by community level outbreaks in at least one other country in a different WHO region in addition to the criteria defined in Phase 5. Designation of this phase will indicate that a global pandemic is under way.

The H1N1 virus was spread widely among humans in many different countries across several different WHO regions.

As we constantly need to remind people like Ms. Tocco, before the virus really got going in the U.S., we really did not have a very good idea of what it was going to be like. It was a novel strain with little history. We did not know whether it would be mild, comparable to the seasonal flu or deadly. We did know that it was uncharacteristic, coming out of the blue and completely off-season. We also knew that it shared some similarities with the 1918 flu that killed millions, so there was definitely reason to be concerned. Because of the unknowns, we prepared for the worst, a "better safe than sorry" approach. Had the government not done so, and the 2009 H1N1 flu been deadly, there would have been a hue and cry, "Why didn't they act sooner?!" As it happened, this novel strain turned out to be relatively mild compared to expectations, though it did kill quite a number of people (275 pediatric deaths during the regular flu season).

Tocco then goes on to refer to the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system set up to capture reports of adverse events following vaccination. She either doesn't understand what VAERS does, or purposefully misconstrues VAERS to scare her readers. VAERS is okay for finding trends for further study, but it cannot be used to show an actual causal relationship between a vaccine and an event. After all, one person even reported that a vaccine turned him into the Hulk.

Ms. Tocco also claims that the 2009 H1N1 vaccine was rushed to market. Well, yes and no. It was rushed in the sense that there was a potential health catastrophe looming, so the vaccine needed to get out quickly and was approved for expedited review. But it was not really rushed in the sense of cutting corners or not getting approval. Basically what the manufacturers did was take an existing, approved vaccine (seasonal flu vaccine) and use a different influenza serotype. They didn't need to come up with and test a brand spankin' new vaccine; they just needed to do some minor tests to ensure nothing was tragically and horribly different. They didn't need to take the time to calculate which serotypes were going to be the problem, since they already knew it was H1N1. All they needed to do was grow the virus like they normally do every year for the seasonal flu vaccine.

Next, we're treated to some very scary-sounding numbers:

According to the CDC Vital Statistics Report 1999-2003, Influenza death for children under the age of 5 skyrocketed as they began to implement the flu vaccine for the children. From 1999 to early 2002, death rates were declining from 25 down to 10 per year then the latter half of 2002 the CDC mandated the flu vaccine for children and the death rate climbed from 25 deaths per year in 1999 to over 90 in 2002!

And of course, Tocco claims that this is a side effect of the vaccine. What she fails to provide, however, is context or any evidence of any causal connection. For instance, how many children actually received the flu vaccine? Why did she pick 1999 as the starting point and 2002 as the end point? What happens if we take a look at the raw numbers for each year?

For children under 5 years of age from the earliest Vital Statistics Report available to the most recent final data, the total number of deaths, with all ages in parentheses, from influenza are (links are PDFs, prior years did not break out by age):

1997: 22 (720 overall)
1998: 9 (1,724 overall)
1999: 25 (1,665 overall)
2000: 19 (1,613 overall)
2001: 13 (257 overall)
2002: 12 (727 overall)
2003: 90 (1,792 overall)
2004: 36 (1,000 overall)
2005: 38 (1,812 overall)
2006: 37 (849 overall)
2007: 32 (411 overall)

So, we see some wobbling of the total numbers. 2003 looks to be an odd year out as far as pediatric deaths go, but as CDC reports and the overall numbers suggest, that was an influenza outbreak year, with a greater total number of infections.

Compare this with the list of years and deaths attributable to influenza that Tocco provides. Note that she does not provide links to her source, but simply lists it as "CDC Vital Statistics Report 1999-2003, Neil Miller Reported." By the way, it turns out that Neil Miller happens to write for whale.to, so it is little wonder that Ms. Tocco gets her facts stupendously wrong.

1999 — 29 deaths
2000 — 19 deaths
2001 — 13 deaths
2002 — 12 deaths
2003 — 90 deaths (Year of mass vaccinations of children under age 5 years)
2006 — 78 deaths
2007 — 88 deaths
2008 — 116 deaths (40.9% vaccinated at age 6 months to 23 months)

Perhaps Ms. Tocco should have gone directly to the source, the CDC, for her numbers, rather than taking the word of someone who is unabashedly anti-vaccine and who writes for a site that is well known to be reality-challenged. Of course, all of this ignores the fact that influenza is not a reportable disease, so the numbers reported above may not be accurate. Some years, surveillance may be lax, so an individual may not be tested for influenza prior to death, thus resulting in lower reported deaths due to the virus. In other years, health care providers and other public health officials may be more vigilant, meaning more tests and more reports of infection, thus, higher numbers of deaths reported as due to influenza. Then there is the matter of case definitions. Were all of these reported deaths confirmed by labs as actually being influenza and not a similar illness? Were there other deaths caused by influenza but attributed to something else?

The other thing to note is that Ms. Tocco cites flu deaths and states, based on some unknown evidence that she apparently wishes to keep secret, that those deaths were not due to natural infection, but rather were caused by the flu vaccine. Despite my best attempts, I was unable to find any citation for this claim in her article.

Let's take a look, too, at when the various flu vaccines were approved:

FluMist - Approved June 17, 2003 for 5-49 year olds. Age range expanded to 2-49 on Sept. 19, 2007. Since this was not approved for under 5 years old until 2007, it likely plays no role in Ms. Tocco's proposed flu vaccine calamity.
AFLURIA - Approved September 28, 2007. The 2009 H1N1 formulation approved for 6 months - 17 years on November 10, 2009. Again, this was approved long after the "horror" year of 2003.
Agriflu - Approved November 27, 2009 for 18 years and older. It has not been approved for marketing for children under 18 years.
Flulaval - Approved for adults 18 years and older on October 5, 2006. It has not yet been approved for use in anyone younger than 18 years of age.
Fluarix - Approved August 31, 2005 for adults 18 years and older. Approved for children 3 years and older on October 19, 2009.
Fluvirin - Approved in 1988 (PDF). Approved for ages 4 years and up.
Fluzone - Approved in 1980. Approved for ages 6 months and up.

There are only two vaccines that were in pediatric use prior to the supposed jump in flu-related deaths: Fluvirin and Fluzone. Those had been in use for a significant amount of time prior to the increase in flu deaths. We should have seen at least some increases before 2003 if vaccines are implicated, since they were in use, even if not on the recommended schedule, for quite some time.

Did I mention how Tocco abuses VAERS data to scare readers? After talking about all those deaths, for which she provided no evidence connecting them to vaccines, she goes on to cite VAERS reports of miscarriages following vaccination of pregnant women. Apparently, Ms. Tocco did not, as directed, read and understand the caveats about VAERS data, particularly the bit about how the database includes coincidental events. That is, there are things that, by chance, occurred shortly after administration of a vaccine, but which have no cause-effect connection to the vaccine. At any rate, Tocco cites a report from the National Coalition of Organized Women (NCOW) that supposedly found a lot of miscarriages following influenza vaccination. The only problem is that the report is based on a study that was, to put it mildly, flawed. For more on the lack of science in the study, see what Dr. Steven Novella has to say.

Ms. Tocco also cites flu vaccine inserts that state that no studies have been done to determine the effects in pregnant women. What she fails to say, and perhaps does not understand, is that the package insert is limited to what the manufacturer has done. Inserts are partially marketing materials, and they may make no claims in it for which they have not done studies and received approval from the FDA. Similarly, adverse events listed are what they have gathered either from studies (i.e., established a likely causal connection) or from post-market reporting (i.e., connection may be causal or coincidental); in essence, it is a way for them to cover their butts if an adverse reaction occurs. All that is to say that while manufacturers may not have studied the effects of flu vaccines in pregnant women, others have. Do a search on pubmed.gov for "influenza vaccine pregnancy" and you will pull up hundreds of studies, including this one from 1981 that found no adverse effects on physical or neurological development of infants at birth or 8 weeks of age when the pregnant mother had received a flu vaccine. There is also this document (PDF) from 1984, which states that there has been no evidence that inactivated influenza virus causes adverse effects in pregnant women or their babies. The studies span the years all the way up to the present. You'll also find in that list what can happen if a pregnant woman is infected with the flu.

And what anti-vaccine diatribe would be complete without the "toxin gambit"? Tocco does not disappoint, as she includes a list of vaccine ingredients, which, by the way, is not even accurate. Of course she lists things like formaldehyde (a substance that is produced by the body and used for amino acid synthesis) and human diploid tissues, which she described as "organ and tissue from aborted baby tissue is now used in manufacturing many vaccines." She doesn't mention that Afluria, Fluvirin and FluMist contain no formaldehyde, and there are two things wrong with her statement about diploid tissues: 1) no vaccine contains aborted fetal tissue - they use cell lines that were grown in the lab over decades; 2) influenza vaccines do not use any human diploid cells. Similarly, she lists squalene, a naturally occurring oil that can be found in things like shark liver oil supplements. What she states correctly is that squalene is not approved for use in the U.S. What she fails to also state is that not a single U.S. vaccine uses squalene (which, for those interested in such things, has actually been used in Europe for over 10 years with a decent safety profile).

I will leave the rest of her article to my readers; there is plenty of material there to correct. For someone who describes herself as "a 30+ year independent vaccine researcher," Mary Tocco shows a significant lack of understanding of even basic facts. I am left with the following conclusion: Ms. Tocco is either an incompetent researcher, a grossly mistaken researcher or a researcher who lies to advance her agenda. This is, of course, my opinion based upon one article on her site that is riddled with fear- and conspiracy-mongering books that you can acquire in exchange for monetary compensations to Ms. Tocco or other authors. As always, I am open to changing my opinion and correcting my article should compelling evidence warrant, but for now, I feel my assessment of Ms. Tocco is reasonably accurate.

Science-y Facts Bubble to the Surface

2011-08-01T07:01:00.000-04:00

There are a lot of TV shows out there. No, really! Take a look. There's a lot of stuff that has been made, much of it short lived. Almost all of them, rather shockingly, have little bits and pieces that bear some passing resemblance to reality, and some even include topics that touch on science or scientific ideas. The good ones may stretch imagination a bit and force us to suspend disbelief, but we're okay with that; the story is intriguing, the logic internally consistent (mostly). Then there are those that make no sense whatsoever. They have plot holes big enough to sail a cruise ship through.

For whatever reason, I watched a show that fell into the latter category. It only lasted one season before being canceled, and I watched every single episode. Why do this to myself? Why put myself through such mind-boggling nonsense? Well, one, because I have Netflix and I could stream it; two, because there was an intriguing element to the storyline, wondering how things might end; and finally, because I just couldn't believe that they could get simple scientific ideas so completely wrong. The writers just had to redeem themselves.

So what is this show that threatened to cause my neurons to vaporize in a blaze of burning stupid? A 15-episode series called Surface:

At first, I thought that watching the show might make for a good drinking game: every time there's a plot hole, drink; but upon further consideration, I realized that would very quickly lead to alcohol poisoning and either a coma or death. Instead, I will educate all of you ignorant fools who thought that you knew a thing or two about reality and show you just how wrong you are. Without further ado, I present to you:

Science I Learned from Watching Surface

Large reptilian creatures that lay eggs and lack mammary glands are actually mammals! Now, you may argue that there are similar animals that are considered mammals like the platypus. Yes, platypuses (platypi? platypodes?) lay eggs, but they have mammary glands. That has been the predominating feature that defines mammals: mammary glands. Well, no more! According to Dr. Laura Daughtery, a marine biologist, upon catching a fleeting glance of one of these behemoth amphibians, says that it is a mammal. This is reinforced by another character, Dr. Aleksander Cirko, who discovers the carcass of one washed up on shore. Defying all classification schemes, this creature is not a reptile or amphibian. It is, in fact, a mammal.
To find the depth of the ocean floor or find objects underwater, scientists use radar instead of sonar. Some among you may have learned that water, especially seawater, absorbs microwaves, which includes radio waves. Not so. Once again, Dr. Laura Daughtery gives us this bit of wisdom, asking her friend to use radar to find out how far down the ocean floor is. So the next time you are going out on a boat, if you want to find out the distance through water of some object, do not use sonar, use radar.
This next one is more about engineering than strictly science knowledge, but apparently it is possible to build a submersible, with working air scrubber, sonar (or maybe radar), portholes, lights and other electronics and so on in less than a week. Okay, willing suspension of disbelief. No one wants to see months and months of building and testing the rig to make sure it works, so I suppose I can let this one slide. Besides, Dr. Laura and her crazy buddy Rich (whose brother was dragged into the depths after spearing one of the big mammals during a dive) are on a schedule. They managed to figure out the migration pattern of the creatures, and the critters are only going to be at a spot for observation for one day!
Which brings us to the next bit. When large aquatic animals, like whales or mammalian amphibians that lack mammary glands and happen to have a connection to electric eels, migrate, contrary to popular belief, they don't hang around an area for days or weeks. They only like to hang out for a day, two tops. So if you want to see them, you need to find the exact spot they migrate to and get there on exactly the right day. Do that, and you'll be sure to catch a glimpse of them. If not, you'll just have to hang around somewhere to see the migratory creatures that didn't actually migrate, 'cause of course, a migratory species doesn't actually migrate unless there's a time-sensitive plot point to achieve.
Remember that homemade submersible? Well, if you choose to build one, remember to install an inflatable life raft on the outside, just in case the cable breaks. You see, I also learned a little about buoyancy from this show. A life raft big enough to hold two comfortably or four cramped, if inflated around 7,000 feet underwater, will happily lift your several ton tin can and many more tons of steel cable up to the surface. Not only that, but when your air scrubber fails and you only have minutes of oxygen left to breathe, don't worry. The life raft will get you to the surface in no time at all, so you won't pass out or suffer any ill effects of oxygen deprivation and CO₂ intoxication. And because you're in a submersible, you won't have to worry about the bends.
Remember how I mentioned the creatures are related to electric eels? That's because they are able to emit an electromagnetic pulse that stuns or kills their prey and shorts out any electrical equipment within a rather large radius. This show taught me how to protect my precious electronics, like a digital video camera, from high bursts of EM radiation: duct tape. Now, I already knew that this was some pretty amazing stuff. You can use it to fix just about anything. You can fix a leaky boat or build a working sailboat out of it. You can even use it to make a cannon! Duct tape, I had been taught many years ago, is like the Force. It has a light side and a dark side and binds the galaxy together. Thanks to this show, I have learned that it can also be used to block EM radiation! Just a thin layer wrapped around your electronic equipment will protect it from an electromagnetic pulse that, lacking a few millimeters of fabric and adhesive, would otherwise fry it like an egg. If only Morpheus knew about this wonder material, he wouldn't have had to shut down the Nebuchadnezzar:

I could go on, but I think you get the idea. There are a number of other things that I either forgot or about which my brain has rebelled and refuses to recall. I did, however, find a review of the show from 2009, courtesy of a blogger named Amanda. She pretty much nails the feel of the show and the plots holes I hinted at earlier.

Hopefully if the writers of Surface ever make another show, they'll consult The Science & Entertainment Exchange first.