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The General Medical Council to Andrew Wakefield: “The panel is satisfied that your conduct was irresponsible and dishonest”

BACKGROUND

In my not-so-humble opinion, the very kindest thing that can be said about Andrew Wakefield is that he is utterly incompetent as a scientist. After all, it’s been proven time and time again that his unethical and scientifically incompetent “study” that was published in The Lancet in 1999 claiming to find a correlation between vaccination with MMR and autistic regression in autistic children with bowel symptoms was at best dubious science and at worst fraudulent. For one thing, as investigative journalist Brian Deer found, Wakefield was in the pocket of trial lawyers, who were interested in suing vaccine manufacturers, to the tune of £435,643 in fees, plus £3,910 expenses beginning even before his infamous “study” started accruing patients. Even though the study itself used the typical careful and relatively neutral language that we all expect from scientists, Wakefield himself was not nearly so circumspect. In a press conference announcing the Lancet study, he said:

He told journalists it was a “moral issue” and he could no longer support the continued use of the three-in-one jab for measles, mumps and rubella.

“Urgent further research is needed to determine whether MMR may give rise to this complication in a small number of people,” Dr Wakefield said at the time.

And so began one of the most contentious health stories of this generation.

Wakefield’s Lancet paper, even interpreted as sympathetically as possible, concluded nothing that justified such language. Yet his rhetoric, along with sensationalistic and credulous British journalists, ignited a firestorm of fear over the MMR that has not yet subsided now, over a decade later. Vaccination rates plummeted in the UK, and measles, a disease once thought to be under control, has surged back and become endemic again. It is a feat that Jenny McCarthy and Jim Carrey appear to be trying to replicate right here in the U.S. with their wonderfully Orwellian-named Green Our Vaccines activism and ceaseless promotion of anti-vaccine messages.

More recently, at the Autism Omnibus hearings, we learned from a world expert in the polymerase chain reaction, Dr Stephen Bustin, that the techniques used in the laboratory running PCR on the clinical specimens from Wakefield’s clinical trial were so shoddy, so devoid of routine controls necessary in any PCR experiment, that the measles sequences reported as amplified in Wakefield’s followup to his Lancet study were false positives derived from plasmids with measles sequences in them contaminating the laboratory. Then, in late 2008, Mady Hornig and colleagues at Columbia University published an attempted replication of Wakefield’s study. They failed. There was no association between vaccination with MMR and autistic regression, nor could Hornig find any evidence that measles in the gut was any more common in the autistic children studied than in the neurotypical controls. This study was particularly devastating to Wakefield because it was carried out by a researcher who had previously been sympathetic to the myth that vaccines cause autism, as evidenced by her infamous “rain mouse” study and, even more close to home, using the same laboratory that had performed Wakefield’s PCR, which had apparently cleaned up its act in the years following its work on Wakefield’s specimens.

When it comes to the science, there is no doubt. No reputable scientist has been able to replicate Wakefield’s findings, and there is a remarkable convergence and agreement of findings of major studies looking for a correlation between MMR vaccination and autism: There ain’t one. Indeed, closing out 2009 was the publication of yet another study that failed to find any correlation between MMR and autism, or, as I put it at the time, yet another nail in the coffin of the myth that the MMR vaccine causes autism. Andrew Wakefield’s repeated claims that the MMR can cause or “trigger” autism in some children is deader than dead as a scientific hypothesis and without a basis in scientific or clinical evidence. True, Wakefield tried to counter with a horribly unethical and badly designed primate study that seemed custom-designed to be used in court rather than in the court of scientific inquiry. It didn’t help and only made Wakefield’s Thoughtful House, Wakefield’s Fortress of Solitude in Texas to which he retreated in the wake of the revelations about his conduct, look even worse. Even a credulously “balanced” TV story by NBC news and Matt Lauer couldn’t hide the dubiousness nature of what goes on there.

Of course, while the science refuting Wakefield’s pseudoscience and evidence showing Wakefield to be incompetent and unethical continued to roll in, a little less than a year ago, it got even worse for him. Brian Deer reported that Wakefield very well may have engaged in scientific fraud in the “research” (and I do use the term loosely) that led to the publication of his Lancet paper in 1999. Through it all, the General Medical Council began an inquiry into whether Andrew Wakefield behaved unethically in the “research” that resulted in his 1999 Lancet report. It should be pointed out that the investigation of the GMC began before Deer’s latest revelation of potential fraud; rather it was far more concerned with how Wakefield ran his study and recruited patients. Nonetheless, the revelations nearly a year ago about Wakefield’s playing fast and loose with research methodology could not help but contribute to the sense that the Good Ship Wakefield had been torpedoed below the water line and was taking on water fast.

As the investigation and hearings wound on seemingly endlessly for two and a half years, Wakefield’s supporters intermittently waged an increasingly histrionic and ridiculous propaganda offensive to try to preemptively discredit the GMC’s findings. As it became clear that finally after all this time the GMC was on the verge of announcing its ruling, I noticed that the anti-vaccine crank blog Age of Autism was ramping up an increasingly bizarre and unhinged last minute propaganda campaign, complete with reposting a hilariously inapt post by Mark Blaxill comparing Wakefield to Galileo and the GMC to the Inquisition, complete with references to Stalin and Mao (I suppose I should be relieved that Blaxill refrained from playing the Hitler card); a defense of “that paper” by Wakefield himself; claims that parent witnesses had been “silenced” at the GMC hearings; and a whole series of posts by John Stone trying to discredit the GMC.

And then on Thursday, the GMC ruled.

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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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The Tamiflu Spin

I will start, for those of you who are new to the blog, with two disclaimers.

First, I am an infectious disease doctor. It is a simple job: Me find bug. Me kill bug. Me go home. I spend all day taking care of patients with infections. My income comes from treating and preventing infections. So I must have some sort of bias, the main one being I like to do everything I can to cure my patients.

Second, in 25 years I have, to my knowledge, accepted one thing from a drug company. The Unisin (that’s how I spell it) rep, upon transfer from my hospital, sent me a Fleet enema with a Unisin sticker on it. I show it proudly to all who enter my office. I do not even eat the drug company pizza at conference, and I cannot begin to tell you painful that is.

As we leave (I hope) the H1N1 season and enter seasonal flu season, there has been a flurry of articles, originating in the British Medical Journal , questioning whether oseltamivir is effective in treating influenza. The specific complaint at issue is whether or not oseltamivir prevents secondary complications of influenza like hospitalization and pneumonia. Although you wouldn’t guess that was at issue from the reporting.  As always, there is what the data says, what the abstract says, what the conclusion says, and what other people say it says.  Reading the medical literature is all about blind men and elephants.

There is, evidently, going to be an investigation by the European Union Council of Europe  into whether or not the H1N1 pandemic was faked to sell more oseltamivir. Sigh.
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Posted in: Pharmaceuticals, Politics and Regulation, Public Health, Science and the Media

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The Mythology of Larry Dossey

A “Double Standard”?

Last week I had planned to write a comprehensive critique of a recent comment by Larry Dossey. He had posted it on Val Jones’s betterhealth website in response to Dr. Val’s essay, “The Decade’s Top 5 Threats To Science In Medicine,” originally posted here on SBM. Much of what Dr. Val had identified as the top threats involved recent dalliances, by government, medical schools, and the media, with the collection of implausible and mostly nonsensical health claims that advocates have dubbed “CAM.” As uncontroversial as Dr. Val’s assertions ought to have been—similar to suggesting that closing one’s eyes and “using the force” would be a threat to safe driving (even if some might quibble over the top threats to science in medicine)—Dr. Dossey demurred by distraction:

Your article implies that conventional medicine is grounded in evidence-based research and that CAM is not. This is grossly overstated, and suggests that a double standard is being applied to these fields.

Dossey trotted out familiar arguments: “Much, if not most, of contemporary medical practice still lacks a scientific foundation”; “the Congressional Office of Technology Assessment (OTA) found that only an estimated 10 to 20% of the techniques that physicians use are empirically proven”; hospital care is “the third leading cause of death in the United States,” accounting for hundreds of thousands of deaths each year.

He concluded with an appeal to fairness, rationality, and collegiality:

Overwhelming evidence reveals that conventional medicine is, on the whole, woefully unscientific. It’s fashionable and easy to deny this, but the facts say otherwise. So, by all means, Dr. Val, be critical of CAM – but do not fall into a double standard. Let us ruthlessly apply science to ALL we do as physicians. Let us challenge ALL areas of medicine to a higher standard. On that, I’m pretty sure we can agree.

Keep up the good work.

Sincerely yours,
Larry Dossey, MD

I procrastinated with my own rebuttal, and in the meantime David Gorski responded to similar language found in an article by Dossey (and two other magical thinkers) titled “The Mythology of Science-Based Medicine,” published by the Huffington Post. I’ll not repeat Dr. Gorski’s able rebuttal in any detail, and I’ve already written about much of what this matter brings to mind. Examples are here, here, and here on the perils of conflating science-based medicine and Evidence-Based Medicine (EBM); here on the false dichotomy of modern medicine vs. “CAM”; here on a concise definition of “CAM”; here and here on the mischief spawned by demands to “ruthlessly apply science,” in the narrow, EBM sense of the word, to implausible health claims; here (point #7) and here regarding the tu quoque fallacy, the “10-20% empirically proven” claim, and the risks of modern health care; here (scroll down to “this week’s entry”) and here, regarding some of Dossey’s own opinions about science and the future of medicine.

For now I’ll elaborate on a few points. These pertain not only to Dr. Dossey but also to myths common to the advocacy of pseudomedicine, so I hope to provide some useful information.

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Posted in: Energy Medicine, Faith Healing & Spirituality, History, Medical Academia, Politics and Regulation, Science and Medicine, Science and the Media

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Be careful what you wish for, Dr. Dossey, you just might get it

If there’s one thing about the so-called “complementary and alternative medicine” (CAM) movement that I’ve emphasized time and time again, it’s that its adherents have a definite love-hate relationship with science. They hate it because it is the single greatest threat to their beliefs system and the pseudoscience that underlies it. At the same time, they crave the legitimacy that science confers. They crave it not because they have any great love for science. Quite the contrary. It is simply that they recognize that science actually delivers the goods. Of course, they believe that they deliver the goods too, but they come to this belief not through science but rather through all the cognitive shortcomings and biases to which humans are prone, such as confusing correlation with causation, confirmation bias, not recognizing regression to the mean, and being fooled by the placebo effect. Whether it’s through a misunderstanding of science or less innocent reasons, they go to great lengths to torture it into superficially appearing to support their claims through a combination of cherry-picking of studies that seem to support them and misrepresenting ones that don’t, discussions of which abound right here in this very blog.

The other thing I’ve emphasized about the CAM movement is that, even more than scientific credibility, they crave legitimacy. To them, however, science is but one pathway to legitimacy, because, unlike practitioners of science-based medicine, they are more than willing to bypass science to obtain the legitimacy–or at least the appearance of the legitimacy–they so crave. If it means doing an end run around science by trying to hijack the Obama health insurance reform bill that is currently being negotiated to resolve the differences between the Senate and House versions, so be it. Indeed, earlier this year, I described how Senator Tom Harkin has tried to promote CAM through the National Center for Complementary and Alternative Medicine (NCCAM) and trying to insert provisions into the bill that would mandate that government-subsidized insurance exchanges pay for CAM. Meanwhile, prominent CAM advocates have been carpet-bombing the media with dubious arguments in support of CAM, as in when Deepak Chopra, Rustum Roy, Dean Ornish, and Andrew Weil teamed up in different combinations to promote the idea that CAM is all about “prevention” and that science-based medicine, in all its reductionistic evil, is nothing more than pushing pills.

They’re at it again.
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Posted in: Energy Medicine, Herbs & Supplements, Homeopathy, Medical Academia, Neuroscience/Mental Health, Politics and Regulation

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The anti-vaccine movement strikes back against Dr. Paul Offit

In my five years in the blogosphere, two years blogging for SBM, and over a decade in Internet discussion forums about medicine and “alternative” medicine, I’ve learned a few things. One thing that I’ve learned is that one of the biggest differences between those whose world view is based on science and who therefore promote science-based medicine and those promoting pseudoscience, quackery, and anti-science is that science inculcates in its adherents a culture of free, open, and vigorous debate. Indeed, to outsiders, this debate can seem (and sometimes is) vicious. In other words, if you’re going to be a scientist, you need to have a thick skin because you will have to defend your hypotheses and conclusions, sometimes against some very hostile other scientists. That same attitude of a Darwinian struggle between scientific ideas, with only those best supported by evidence and with the most explanatory power surviving, is a world view that those not steeped in science have a hard time understanding.

Among those who don’t understand science, few have a harder time with the rough-and-tumble debate over evidence and science that routinely goes on among scientists than those advocating pseudoscience. Indeed, in marked contrast to scientists, they tend to cultivate cultures of the echo chamber. Examples abound and include discussion forums devoted to “alternative” medicine like CureZone, where never is heard a discouraging word — because anyone expressing too much skepticism about the prevailing view on such forums invariably finds himself first shunned by other members of the discussion forums and then, if he persists, booted from the forum by the moderators. In marked contrast, on skeptical forums, most of the time almost anything goes. True, the occasional supporter of woo who finds his way onto a skeptical forum will face a lot of criticism, some of it brutal. However, rarely will such a person be banned, unless he commits offenses unrelated to his questioning of scientific dogma, such as insulting or abusive behavior towards other forum participants or trolling. Such people may annoy the heck out of us skeptics sometimes, but on the other hand, they do actually from time to time challenge us to defend our science and prevent us from becoming too complacent. Indeed, that’s what I like about skeptics and being a scientist. Nothing or no one is sacred.
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Posted in: Chiropractic, Politics and Regulation, Public Health, Vaccines

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2009’s Top 5 Threats To Science In Medicine

As 2009 comes to an end, it seems that everyone is creating year-in-review lists. I thought I’d jump on the list band wagon and offer my purely subjective top 5 threats to rational thought in healthcare and medicine.

Of course, it strikes me as rather ironic that we’re having this discussion – who knew that medicine could be divorced from science in the first place? I thought the two went hand-in-hand, like a nice antigen and its receptor… and yet, here we are, on the verge of tremendous technological breakthroughs (thanks to advances in our understanding of molecular genetics, immunology, and biochemistry, etc.), faced with a growing number of people who prefer to resort to placebo-based remedies (such as heavy-metal laced herbs or vigorously shaken water) and Christian Science Prayer.

And so, without further ado, here’s my list of the top 5 threats to science in medicine for 2009 and beyond:
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Posted in: Politics and Regulation, Science and Medicine, Science and the Media

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A temporary reprieve from legislative madness

While doctor visits for influenza-like illnesses seem to be trending downward again, and “swine flu” is becoming old news, I’d like to draw attention to an H1N1 story that has received very little coverage by the mainstream media.

Doctors in several states can now protect their most vulnerable patients from the H1N1 virus without worrying about breaking the law. In order to save lives, several states have announced emergency waivers of their own inane public health laws, which ban the use of thimerosal-containing vaccines for pregnant women and young children.

Legislators in California, New York, Illinois, Missouri, Iowa, Delaware, and Washington state have enacted these science-ignoring laws in response to pressures from the anti-vaccine lobby and fear-struck constituents. Except for minor differences, each state’s law is essentially the same, so I will focus on the one from my state of New York.

New York State Public Health Law §2112 became effective on July 1, 2008. It prohibits the administration of vaccines containing more than trace amounts of thimerosal to woman who know they are pregnant, and to children under the age of 3. The term “trace amounts” is defined by this law as 0.625 micrograms of mercury per 0.25 mL dose of influenza vaccine for children under 3, or 0.5 micrograms per 0.5 mL dose of all other vaccines for children under 3 and pregnant women. Because thimerosal (and thus, mercury) exists only in multi-dose vials of the influenza vaccines (both seasonal and novel H1N1), this law really only applies to these vaccines. The mercury concentration of the influenza vaccines is 25 micrograms per 0.5 mL, which therefore makes their use illegal. Unfortunately, the only form of the H1N1 vaccine initially distributed, and that could be used for young children and pregnant women, was the thimerosal-containing form. The thimerosal-free vaccine was the last to ship, and in low supply, and the nasal spray is a live-virus vaccine, not approved for use in pregnancy or children under 2. That meant, without a waiver of the thimerosal ban, these groups could not be vaccinated.
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Posted in: Politics and Regulation, Public Health, Science and Medicine, Vaccines

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The Institute for Science in Medicine enters the health care reform fray

I’ve been writing about the attempts of proponents of various pseudoscience, quackery, and faith-based religious “healing” modalities to slip provisions friendly to their interests into the health care reform bill that will be debated in the Senate beginning today. If you want to know what’s at stake, check out the first press release of a newly formed institute designed to promote science-based medicine in academia and public policy, the Institute for Science in Medicine.

It’s an embryonic institute, only recently formed by 42 physicians and scientists, several of whose names will be quite familiar to regular readers of SBM, but it’s jumping right into the fray. This is what the ISM is:

The ISM is a non-profit educational organization dedicated to promoting high standards of science in all areas of medicine and public health. We are a watchdog group of medical professionals who believe the best science available should be used to determine health policy and establish a standard of care that protects and promotes the public health. We oppose legislation that seeks to erode the science-based standard of care and expose the public to potentially fraudulent, worthless, or harmful medical practices or products.

Given how when faced with science going against them purveyors of unscientific medicine and medical beliefs try to win in politics where they can’t win in science (as my earlier post today describes for naturopaths in Ontario and the anti-vaccine movement in Oregon), just as we do on SBM, those of us who have helped to form the ISM have our work cut out for us.

Steve Novella has more.

Posted in: Announcements, Herbs & Supplements, Politics and Regulation, Public Health

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Naturopaths and the anti-vaccine movement: Hijacking the law in service of pseudoscience

Time and time again, we’ve seen it. When pseudoscientists and quacks can’t persuade the scientific and medical community of the validity of their claims, they go to the law to try to gain the legitimacy that their claims can’t garner through proving themselves by the scientific method. True, purveyors of pseudoscience and unscientifically-derived medical practices do crave the respectability of science. That’s why they try so hard to take on the trappings of science. The problem is that they just can’t do it right, try as they might, or when they do it right their methods are shown to be no more effective than a placebo, aside from the occasional seeming “positive” results that would be expected based on random chance alone. However, failing to achieve the respectability that the mantle of science provides, practitioners and advocates of pseudoscience frequently try to codify their woo into the law.

The reason that they would do this is not too hard to discern. Few legislators and politicians are scientists, and even fewer are scientifically inclined. Back when I still lived in New Jersey, I may have been lucky enough to have had a Congressional Representative who really was a rocket scientist (well, a physicist, actually), but now that I live in Michigan I’ve gone from having a scientifically inclined Congressional representative to having one of the dimmest bulbs in Congress representing me. What that means is that it’s far easier to persuade politicians that this woo or that woo deserves to be permitted or even licensed. That’s how we now have many states licensing acupuncturists, naturopaths, and even “homeopathic physicians,” as Arizona does. The pressure for this sort of acceptance of unscientific medical modalities is building, as well, as Kimball Atwood has documented. Another example is the Dietary Supplement Health and Education Act (DSHEA), which was passed in 1994 and in essence ties the FDA’s hands when it comes to regulating most supplements. Indeed, the very existence of the National Center for Complementary and Alternative Medicine (NCCAM) is a testament to the success of this approach, as a powerful Senator (Tom Harkin, D-IA) almost single-handedly foisted this scientific atrocity on the NIH against the desires of scientists. The results have included a $30 million scientific boondoggle of a trial to test chelation therapy and a profoundly unethical trial of Dr. Nicholas Gonzalez’s “protocol” for pancreatic cancer patients that a recent clinical trial has shown to be worse than useless. The most recent example of this trend is the way that CAM supporters have tried to hijack President Obama’s health insurance reform initiative to insert coverage for everything from any licensed “alternative medicine” practitioner to Christian Science prayer healing.

Recently, two new fronts have been opened up in this battle. One is disturbingly close to me, as it involves the Canadian province of Ontario whose north shore on the Detroit River is less than two and a half miles from my office, the other in Oregon, which, although it’s happening nearly 2,000 miles away from where I live and practice, could portend a new and disturbing tactic of the anti-vaccine movement to do what various other purveyors of pseudoscience have done before and try to win in state legislatures where they can’t win in science or the courts. Of course, in a democratic republic, it is the right of everyone, even supporters of quackery, to try to petition his or her legislators, but it is equally the responsibility of those of us supporting science-based medicine to try to educate legislators why allowing them to alter the law to protect their pseudoscience has the potential to result in great harm.
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Posted in: Herbs & Supplements, Politics and Regulation, Public Health, Vaccines

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“Move along. Nothing to see Here”- F. Drebin

I am, I think, the slowest writer in the  SBM stable.  I start each entry about 10 days before it is due, and work diligently on it through the week.  As such, I run the risk that events may make my work pointless. Case in point.  I have been slogging away at this entry for the last week and had the final draft up and ready to go, only to find this morning that the Health Care Reform bill no longer carries the language that was the crux of this entire post.  So what is a poor, slow, SBM writer to do? Chuck the whole thing?  Repost my 12 reasons you are a dumb ass not to get the flu vaccine yet again? Leave a hole in the SBM line up? No.

Lets pretend we are in a parallel universe, perhaps an evil universe  where I have a goatee, and the language was not removed from the bill. Lets all pretend that this post is still relevant. Since the Christian Science Church has indicated they will try to get the bill amended to reinstate payment for their services, this post may be relevant again.

Or you could go read  Respectful Insolence instead. Don’t say you were not warned.
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