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Fakin’ it

Last week the Times of London revealed inside information from the General Medical Council (UK, responsible for physician licensing) of an ongoing investigation of Dr. Andrew Wakefield and from its own investigation. This revelation recalled other instances of fakery from reports of sectarian medicine (“CAM”) successes. The Medical Council information contained evidence that the data from the now famous Wakefield cases used to claim an association of the MMR vaccine with childhood autism and inflammatory bowel disease were misinterpreted, altered, and to some extent, faked. The report and history were reviewed by David Gorski last week. In eight of twelve cases, the dates of autism onset were “rearranged” to fit the needed time association, and many small bowel biopsies were “reinterpreted” to show inflammation.

The Wakefield claims were long suspected by reputable medical scientists and skeptics  as being erroneous or fraudulent.  Note: the Council hearings are still in progress, and the Times report is subject to legal complaint.  The original details can also be seen in the Times articles.

This expose’ adds to a growing list of reports with erroneous and faked information in medical journals used either for economic reward, undeserved fame, or to promote ideological claims for medical sects and cults. Although history of erroneous or false claims goes back hundreds of years, the altering or synthesizing of data passing the recently conceived peer review system is new,  illuminating defects in the journal peer review and editing system.

If journals were invented in the 18th century, and operated like journals of today, Mesmer’s demonstrations might have been published, and the Ben Franklin and Antoine Lavoisier and French Academy’s disproof might have been rejected. (Laughter here.) But journals continue to make major goofs in publishing implausible results despite the popularity of a famous specialty journal for that purpose.

Examples vary from acceptance of language manipulation – “alternative,” “healing,” “integrative,” etc., to the fakery of recent papers showing effects of prayer. The two famous studies of prayer in the cardiac care unit ranged from the unadmitted breaking of the blind in the Bird study (So Med J 1988; 81:826-826) to unadmitted imbalances of subject and control groups (Harris, Arch Int Med 1999;159:2273-2278.) And from those to the likely fakery of the distant prayer study of in vitro fertilization (Cha, Wirth, Lobo; J Reprod Med 2001:46;781-786) in which three separate prayer groups on two continents improved pregnancy rates in a group of women on a third continent by an implausible 100 percent. In all of these cases, the papers passed peer or editorial review despite the methodological defects that were picked up by us skeptics (K. Atwood, K.Courcey [an RN] B. Flamm, and others.)

Adding insult to the above, Annals of Internal Medicine published a systematic review of intercessory prayer (Astin et al, Ann Int Med, 2000;132: 903-910) containing not only the Bird and Harris studies counted as positive, but also the Targ study on brain tumors, found by reporter Po Bronson to have had its end point altered by the authors when the primary one showed no effect.
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Posted in: Basic Science, Clinical Trials, Faith Healing & Spirituality, Health Fraud, Medical Academia, Science and Medicine, Vaccines

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Antivaccine hero Andrew Wakefield: Scientific fraud?

Pity poor Andrew Wakefield.

Actually, on second thought, Wakefield deserves no pity at all. After all, he is the man who almost single-handedly launched the scare over the MMR vaccine in Britain when he published his infamous Lancet paper in 1998 in which he claimed to have linked the MMR vaccine to regressive autism and inflammation of the colon, a study that was followed up four years later with a paper that claimed to have found the strain of attenuated measles virus in the MMR in the colons of autistic children by polymerase chain reaction (PCR). It would be one thing if these studies were sound science. If that were the case, then Wakefield’s work would have been very important and would have correctly cast doubt on the safety of the MMR. Unfortunately, they were not, and, indeed, most of the authors of the 1998 Lancet paper later withdrew their names from it.

Over the next decade, aided and abetted by useful idiots in the media, by British newspapers and other media that sensationalized the story, and the antivaccine movement, which hailed Wakefield as a hero, Wakefield managed to drive MMR vaccination rates in the U.K. below the level of herd immunity, from 93% to 75% (and as low as 50% in some parts of London). As a result Wakefield has been frequently sarcastically “thanked” for his leadership role in bringing the measles back to the U.K. to the point where, fourteen years after measles had been declared under control in the U.K., it was in 2008 declared endemic again.

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Posted in: Science and the Media, Vaccines

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Since when did an apologist for the antivaccination movement, Dr. Jay Gordon, become an “expert” in vaccine law?

I am an alumnus of the University of Michigan twice over. I completed a B.S. in Chemistry with Honors there in 1984 and then I stayed on to do obtain my M.D. in 1988. I look back very fondly on those eight years spent in Ann Arbor, as several of my longtime friendships were forged or solidified during those years. Consequently, I still care about the place. Indeed, I even once tried to see if I could get a position in the Department of Surgery there a few years back, but unfortunately the “fit” just wasn’t there at the time. That’s why it distresses me when I see my alma mater suffer from a self-inflicted wound, almost as much as the plight of the Michigan Wolverines bothers me, given that never before in my life (at least not since I was old enough to pay attention), have the Wolverines sucked so badly and so hard. Given that level of football futility, though, I consider it even more important that my alma mater not provide any more ammunition to those who would enjoy making fun of it. It doesn’t matter to me that I never went to law school at Michigan; it’s all part of the same campus to me.

This time, the embarrassment comes in the form of an article in the Michigan Law Review by a person who has previously been a subject of posts by both Dr. Novella and me. I’m referring to Dr. Jay Gordon, whom we have both–correctly, I believe–labeled as being, if not fully anti-vaccine, at least a prominent and major apologist for the anti-vaccine movement. Unfortunately, because he is the pediatrician taking care of Jenny McCarthy’s son Evan, he has gained even greater prominence in the antivaccine movement than ever, to the point where he gave a speech last summer to the antivaccine “Green Our Vaccines” march on Washington and where he is regularly called up by TV producers to give a false “balance” whenever a discussion of vaccines and/or autism comes up. He also wrote the foreword to Jenny McCarthy’s latest paean to autism quackery and attack on vaccines as the cause of autism in which he blithely repeated some of the worst distortions of the antivaccine movement. Unfortunately, Dr. Gordon lacks the intestinal fortitude to stop the piteous denials any time he is called out for his parroting of antivaccine pseudsocience and to embrace his inner antivaccinationist. Then, at least, we wouldn’t be treated to the spectacle of his simultaneously claiming he is “pro-safe vaccine, not anti-vaccine” while at the same time saying he “doesn’t give a lot of vaccines” and admitting that parents have actually had to persuade him to vaccinate “reluctantly.”

So what was the topic of the Michigan Law Review article that Dr. Gordon was apparently asked to pen? It’s actually an interesting question from a legal, political and civil rights standpoint, specifically: Whether or not parents should be held legally liable for refusing to vaccinate their children. Not surprisingly, Dr. Gordon took the “no” position. Unfortunately, as we’ve come to expect of Dr. Gordon, he uses a number of highly dubious arguments. However, more interesting to me, having had a nearly four year history sparring online with him off and on, was the seemingly “kinder and gentler” antivaccine stance that he took in this article.

But first, let’s take a look at the debate. The symposium published in First Impressions (the online companion to the Michigan Law Review) was entitled Liability for Exercising Personal Belief Exemptions from Vaccination, and it contained the following articles:

  1. Choices Should Have Consequences: Failure to Vaccinate, Harm to Others, and Civil Liability by Douglas S. Diekema.
  2. Parents Should Not be Legally Liable for Refusing to Vaccinate their Children by Dr. Jay Gordon.
  3. Unintended Consequences: The Primacy of Public Trust in Vaccination by Jason L. Schwartz.
  4. Challenging Personal Belief Immunization Exemptions: Considering Legal Responses by Alexandra Stewart.
  5. Gambling with the Health of Others by Stephen P. Teret and John S. Vernick.
  6. The Problem of Vaccination Noncompliance: Public Health Goals and the Limitations of Tort Law by Daniel B. Rubin and Sophie Kasimow

There were a number of fascinating issues raised here. Although it’s obvious that universal vaccination is a public health policy good, given that the higher percentage of vaccinated children, the greater the herd immunity, there is always the nagging question of how far the state should go to mandate vaccination in a free society; i.e., how much coercion is acceptable to bring about maximal levels of vaccination? In other words, what is the proper balance between the needs of society as a whole and the rights of the individual? The next interesting legal and moral question is whether parents who refuse to vaccinate should be held liable for injuries to other children if their unvaccinated child passes on an infectious disease. Personally, I tend to believe that it is entirely reasonable to require vaccination as a precondition for school or day care and that exemptions should be primarily medical in nature. I grudgingly allow that the freedom of religion guaranteed in the First Amendment probably requires religious exemptions (although I do not understand why religion should be given such a privileged place in society that it can endanger public health), I am far less convinced that philosophical exemptions should be mandated. I realize many may disagree with this position, but I would hope that our disagreements would be based on (1) the best science regarding the benefits and risks of vaccination and (2) honest beliefs regarding the proper balance between public health concerns and individual liberty. Clearly, this is an area of debate. I also tend to believe that if parents refuse to vaccinate their child and that child passes an infectious disease to another child, then those parents should be potentially legally liable. Indeed, Douglas Diekema argues this position very well.

Unfortunately, Dr. Gordon does not meet at least condition #1 above. He does not base his arguments on the best science.
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Posted in: Politics and Regulation, Public Health, Vaccines

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More Data on Vaccine Safety Amid New Outbreaks

The more recent issue of the Journal Pediatrics contains two article providing further evidence for the safety of vaccines and is published amid news reports of recent outbreaks of vaccine-preventable diseases in those who chose not to vaccinate over unwarranted fears. This highlights the need to continue our PR battle against the antivaccinationist movement that seeks to spread pseudoscientific fears about vaccine safety.

The Outbreaks

Haemophilus influenza type B (Hib) is a bacteria that can cause meningitis, pneumonia, and epiglotitis in young children – all serious illnesses. A Hib vaccine was introduced in 1992 followed by a significant decrease in the number of Hib infections. Last year in Minnesota, however, there were five cases of Hib meningitis, including a 7-month old infant who died. This is a significant spike above the rate we have seen since the Hib vaccine, and occuring in a cluster. Three of the five children who were affected did not have the Hib vaccine by their parent’s choice.

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Posted in: Public Health, Vaccines

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The Alleged Autism Epidemic

It is without controversy that the number of autism diagnoses being made is on the rise. In 1991 there were about 6 cases per 10,000 births, and in 2001 there were about 42. This number continues to rise at about the same rate.

The cause of this rise, however, is very controversial. There are basically two schools of thought: 1 – that true autism rates are on the rise, and 2 – that the measured rise is an artifact of increased surveillance and a broadening of the definition. I wrote previously about this very controversy, in which I concluded that the expanded diagnosis hypothesis is much better supported by the evidence.

Now, a new study published last week in the journal Epidemiology is being presented by proponents of the epidemic hypothesis as support for their view. A closer look, however, reveals that this study does not support the epidemic hypothesis and adds little to the overall literature on this question.
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Posted in: Neuroscience/Mental Health, Vaccines

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Animal vaccinations

Without question, vaccination has been one of the most important interventions in disease prevention that has ever been developed. In spite of the demonstrable, and ongoing, success of vaccination, a small, but vocal, anti-vaccination movement has developed in human medicine, occasionally buttressed by horrifying instances of adverse reactions, as well as the occasional publications in scientific journals (vis, the Wakefield debacle). Vaccine development continues, and human health continues to benefit, as new vaccines are developed and tested prior to release.

In veterinary medicine, vaccination has also proven to be a boon for animal health. Diseases such as canine parvovirus and canine distemper, feline leukemia, or equine tetanus, have been greatly reduced – in some cases, nearly eliminated – by vaccination. And, as in human medicine, a small, but vocal, anti-vaccination movement has developed, regaling fearful listeners with tales of acute harm, or chronic, low-grade disease (sometimes termed “vaccinosis”).
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Posted in: Vaccines, Veterinary medicine

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Paul Offit Takes On Robert Sears

Dr. Robert Sears, son of the perhaps more famous Dr. William Sears (both pediatricians), has continued his father’s work of publishing popular books for parents. He wrote The Vaccine Book: Making the right decision for your child, published in October 2007. In it he advocates his Dr. Bob’s Alternative Vaccine Schedule. Much of his claims made in the book are repeated on his Ask Dr. Sears website.

In the latest issue of Pediatrics, Paul Offit, along with Charlotte Moser, write a detailed analysis of Dr. Bob’s alternative vaccine schedule, systematically reviewing Dr. Sears’ claims. It is essential reading for anyone interested in the popular vaccine controversy. Paul Offit also recently published his own book, Autism’s False Prophets, in which he goes into great detail about the history and science behind the claims by anti-vaccination advocates of the risks of vaccines, most famously the claim that vaccines are linked to autism.

Dr. Sears does not come off as a hard core anti-vaccinationist. I am still trying to figure out his perspective from reading his articles. It seems as if he is trying to be popular by straddling the fence, and offering what he thinks might be a reasonable compromise. For example, he writes on his site:

The bottom line is that more and more parents want options. If we don’t provide them with options they are comfortable with, more parents will opt out of vaccines altogether. We will then see more and more disease fatalities and complications.

Unfortunately, this is like trying to compromise between mutually exclusive positions, like young-earth creationism and evolution. It doesn’t work. Dr. Sears is left giving his readers, who will likely be comprised of many parents trying to decide whether or not to vaccinate their children, with partial information or misinformation. Offit and Moser do a great job of exposing this deception through misinformation.

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Posted in: Vaccines

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The $150,000 Vaccine Challenge

At the request of a correspondent from the Quackwatch Healthfraud discussion list, I recently got embroiled in a debate with a couple of anti-vaccinationists in the pages of an Amish community newspaper, Plain Interests, published in Millersburg PA. They followed the usual pattern: they told the same old lies, they told partial truths distorted out of all recognition, and they omitted all those other truths that contradict their beliefs. Then they both challenged me to take all the recommended baby vaccines adjusted for weight to “demonstrate that vaccines are safe and effective.” If I refuse to do this, they say it will show that vaccinators are dishonest and that I’m afraid of my own medicine. They said I could win $150,000 by taking the challenge.

I did a little investigating. There is indeed a published challenge by Jock Doubleday, although the exact amount of money currently offered is unclear. His challenge reads:

The offer will continued to increase $5,000 per month, in perpetuity, until an M.D. or pharmaceutical company CEO, or any of the 14 relevant members of the ACIP (see below), agrees to drink a body-weight calibrated dose of the poisonous vaccine additives that M.D.s routinely inject into children in the name of health. The mixture will include, but will not be limited to, the following ingredients: thimerosal (a mercury derivative), ethylene glycol (antifreeze), phenol (a disinfectant dye), benzethonium chloride (a disinfectant), formaldehyde (a preservative and disinfectant), and aluminum.

According to Ratbags, this offer is bogus. (more…)

Posted in: Public Health, Vaccines

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Influenza Deaths

“There are known knowns. These are things we know that we know. There are known unknowns. That is to say, there are things that we know we don’t know. But there are also unknown unknowns. There are things we don’t know we don’t know.”- Donald Rumsfeld

How do we know what we know? It is said by some anti-vaccine proponents that vaccines are not needed because the diseases they prevent are either gone or no longer as severe as they were in pre vaccine times. People may have suffered and died in the distant past, but no longer. The risk now is from the vaccines not the diseases they no longer prevent.

36,000 people, more or less, die every year from influenza. That is the number of deaths according to the CDC web site; the NEJM review uses the higher number of 56,000 (7). Which number is correct? Isn’t that why the flu vaccine is recommended: to prevent all those people from dying.

36,000 is a lot of people. That’s about 120 deaths per million people in the US. In Oregon, population about 3 million, that would be about 360 people a year, which is two deaths a day for the six month flu season.

“Death is caused by swallowing small amounts of saliva over a long period of time.”–George Carlin.

2,400,000 people die every year in the US, about 6600 a day. In Oregon, that is about 65 deaths a day. No one outside a epidemiologist is going to notice 2 extra deaths a day during flu season. I have seen a lot of people die of influenza, but I have a biased experience: I am an infectious disease doc, so I am likely to see people with influenza, especially patients with disease severe enough to kill them.

About the same number of people die from car accidents and die from handguns in the US each year as die from influenza. I have never known a person in my real, as opposed to my professional, life to die from influenza or handguns or a car accident. My personal experience suggests no one dies from these causes, but since I take care of patients at one of the Portland trauma hospitals, I know what cars and guns do to people. My professional life confirms that people do indeed die from being shot or car accidents. I would wager that most people reading this blog have not known anyone who has died from influenza, guns or car accidents. The fact that people do die of influenza seems contradicted by experience. Why get the vaccine? I don’t get the flu and and no one I know has ever died from it.

As an illustrative example, a relative of mine, a retired physician, mentioned that he thought the shingles vaccine was a waste of time and money as he had never known anyone to get shingles. Using personal experience to judge disease prevalence is unreliable. If I applied the same rationale to driving, I would not wear a seat belt as I have never been in a high speed crash.

36,000 people die of influenza each year. What is the source of that statistic? From “Mortality associated with influenza and respiratory syncytial virus in the United States”. JAMA 2003. Is that really how many deaths are there from influenza? It depends on what you mean by ‘death’ and what you mean by ‘influenza’ and what you mean by ‘from’.

“It depends on what the meaning of the words ‘is’ is.” – Bill Clinton

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Posted in: Basic Science, Public Health, Vaccines

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“I Reject Your Reality” – Germ Theory Denial and Other Curiosities

Note: This article was originally published in Skeptic magazine. Space limitations resulted in omitting some of what I wanted to say. I’m taking advantage of having a blog to publish the entire article as originally submitted.

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On an episode of Mythbusters, Adam Savage was shown a video clip that contradicted his memory of something he had said. He responded, “I reject your reality… and substitute my own.” He was joking. Unfortunately, the world is full of people who reject reality and who are not joking.

James Randi tells a story about a TV program that featured Uri Geller doing his standard trick of bending a key. Afterwards, the program’s host said it couldn’t possibly have been a trick because Uri had “never touched” the key. The host was then shown the recorded program, which proved that Geller clearly had the key in his hands, for two-and-a-half minutes. Instead of admitting having been wrong, the host exclaimed, “Well, that’s not how it happened.”

One of my own ancestors was a pro at this kind of thing. I’ll call her Aunt S (for stubborn). She had once tried tinned sardines, hated them, and refused to ever touch sardines again. One day she came into my grandmother’s kitchen when she was frying up some large fresh sardines a friend had brought her. Aunt S ate some, proclaimed them tasty, then asked, “What kind of fish were those, Mary?” My grandmother told her they were sardines. She protested, “No they weren’t! I don’t eat sardines!”

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