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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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You. You. Who are you calling a You You?

The YOU Docs, for those of you (YOU?) who are unaware, are Doctors Mehmet Oz and Mike Roizen, authors of books about YOU and a weekly newspaper column called The YOU Docs. It’s all about YOU.

There are two areas of the knowledge where I have more than passing understanding: infectious diseases and sCAMs. It always concerns me when I read nonsense in the few areas where I have some expertise. I have to wonder about the validity of other information in the paper like war and the economy. You know, important stuff. It could probably be argued that since the YOU Docs are in the “How We Live” section, the same section that carries horoscopes, the movie and TV reviews, the weather report — the fiction section — it should not taken seriously. After all, it is usually adjacent to the People’s Pharmacist, and my father always told me that you can judge a person by the company they keep.

The YOU Docs had a column with the headline: “Research backs acupuncture for a range of ills“. More fiction? Research backs acupuncture? News to me, but they are, after all, YOU Docs, and therefore may have information not accessible to mere docs with a small ‘d’. I grant up front to the authors that it is hard to be rigorous, or even coherent, in a 452 word essay. I am over 3,200 words for this entry. There are also no references, so I have to assume I found the correct research mentioned by the hints in the text.

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Posted in: Acupuncture, Science and the Media

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James Ray and testosterone replacement therapy (TRT)

For the last four years I have served in a volunteer capacity among a panel of pharmacotherapy experts queried regularly by the ABC News Medical Unit about breaking or upcoming news involving the efficacy and safety of drugs and supplements. Where appropriate, I provide background information that informs the story.

My incentive is largely to put my time where my mouth is when I say that scientists need to take a more active role in making sure medical stories are reported accurately. An additional dividend is paid to my students who then benefit from my presentation of the science behind timely medical developments.

On occasion, perhaps once or twice a year, I’ll be asked for an on-camera interview. Even when this occurs, the resulting story will contain no more than 15 seconds of the interview and some summary by the reporter of other issues we discussed. I take this responsibility very seriously and prepare as much as I can given the deadlines of the press and my daily education and research schedule.

But given airtime constraints, much of what I prepare would normally end up in the abyss of my files and come out in the classroom when I lecture about that particular topic. Blogging, however, now allows us to expand further on stories where we are consulted, giving us an opportunity to air, albeit to a smaller audience, the information we found important from our perspective. Authoring a blog, therefore, takes away the excuse some scientists and physicians have in not wanting to talk to the press: “There’s never enough airtime to tell the whole story the way I would tell it.”

This post was informed by one of those brief appearances, this time on ABC World News Sunday with Dan Harris. The interview was solicited last weekend following the release of information obtained during the execution of a search warrant in lodging occupied by the self-help guru, James Arthur Ray, who led an Arizona sweat lodge ceremony last October where three people ultimately died and almost two dozen were hospitalized. The segment was not archived to the World News website but some ABC affiliates subsequently aired truncated versions of the story.
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Posted in: Diagnostic tests & procedures, Pharmaceuticals, Science and the Media

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The Graston Technique – Inducing Microtrauma with Instruments

The Graston Technique® is a modification of traditional hands-on soft tissue mobilization that uses specifically designed instruments to allow the therapist to introduce a controlled amount of microtrauma into an area of excessive scar and/or soft tissue fibrosis, hoping that this will invoke an inflammatory response that will augment the healing process. It is also intended to reduce the stress on the therapist’s hands.

graston instrumentsGraston treatment

Microtrauma? Hurting people to make them better? I know sometimes an improperly healed bone must be re-broken so it can re-heal in proper alignment, but this is different. It bothers me that they are further injuring already damaged soft tissues and hoping (1) that the new injury will heal, (2) that that will help the older injury heal, and (3) that it can somehow avoid stimulating the deposition of just that much more scar tissue and fibrosis. It seems to violate the “primum non nocere” principle. It is unpalatable. Of course that wouldn’t matter if the evidence showed it was effective. Does it? (more…)

Posted in: Science and the Media

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The “pharma shill” gambit

Editor’s note: Since I happen to be on vacation (sort of–in reality I plan on spending most of next week holed up in my Sanctum Sanctorum at home writing a grant that’s due in February) and because readership tends to be down during the week between Christmas and New Years’ Day, I thought I’d resurrect something from well over three years ago and revise it to fit this particular blog. In doing so, I hope to provide you with something amusing to read, as well as something to link to time and time again whenever you want to refer to a particular gambit beloved by promoters of quackery and pseudoscience. I present here….The “Pharma Shill” Gambit! Enjoy!

I’ve mentioned before on this blog at least once that I cut my skeptical teeth, so to speak, on Usenet, that vast untamed and largely unmoderated territory full of tens of thousands of discussion newsgroups which used to be a lot more active before the rise of the World Wide Web and then later blogs. These days, few ISPs even offer much in the way of Usenet access; it’s become pretty much irrelevant since Google archived Usenet in the form of Google Groups. My forays into skepticism started out with combatting Holocaust denial on a newsgroup known as alt.revisionism (as good an excuse as any to remind you that nearly all Holocaust “revisionism” isn’t historical revisionism but is actually denial) and then branched out into more general skepticism, particularly about the claims of creationists and, of course, promoters of “alternative” medicine, the latter of which ultimately led me to being the editor of this wild and woolly thing we call the Science-Based Medicine blog. After I began to participate in the debates in the main newsgroup where alternative medicine is discussed, misc.health.alternative, it didn’t take me long to encounter a favorite tactic of promoters of alt-med who were not happy with one who insists on evidence-based medicine and who therefore questions claims that are obviously not based in valid science: The “Pharma Shill” Gambit. This is a technique of ad hominem attack in which a defender of “alternative” medicine, offended by your questioning of, for instance, his/her favorite herb, colon or liver flush technique, zapper, or cancer “cure,” tries to “poison the well” by implying or outright stating you must be in the pay of a pharmaceutical company, hired for nefarious purposes.

Since I entered the blogosphere several years ago under another guise, I’ve only occasionally checked back at my old stomping ground, mainly because blogging is so much less constraining than posting to Usenet, where mostly I used to respond to the posts of others, rather than writing about what I wanted to write about. A while back, though, out of curiosity I checked back and found this interesting little tidbit from a poster calling himself PeterB that demonstrated such a perfect example of the “pharma shill” gambit that I thought it might serve as a perfect example of the sort of thing I’ve had to put up with ever since I started speaking out against quackery:
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Posted in: Humor, Science and Medicine, Science and the Media, 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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Lithium for ALS – Angioplasty for MS

Peter Lipson reported Monday about new research suggesting that Multiple Sclerosis may be caused by venous blockage. He correctly characterized some of the hype surrounding this story as “irrational exuberance.”

This is a phenomenon all too common in the media – taking the preliminary research of an individual or group (always presented as a maverick) and declaring it a “stunning breakthrough,” combined with the ubiquitous personal anecdote of someone “saved” by the new treatment.

The medical community, meanwhile, responds with appropriate caution and healthy skepticism. Looks interesting – let’s see some more research. There is a reason for such a response from experts – experience.

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Posted in: Neuroscience/Mental Health, Science and the Media

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An Influenza Recap: The End of the Second Wave

We are nearing the end of the second wave of the 2009 H1N1 pandemic, and are now a few months out from the release of the vaccine directed against it.  Two topics have dominated the conversation: the safety of the 2009 H1N1 influenza vaccine, and the actual severity of the 2009 H1N1 infection.  Considering the amount of attention SBM has paid the pandemic and its surrounding issues, and in light of a couple of studies just released, it seems time for an update.

2009 H1N1 Vaccine Safety

This week the CDC released a report that evaluated the safety record of the 2009 H1N1 vaccine.  The first two months of the vaccine’s use were examined, from October 1st through November 24th using data from two of the larger surveillance systems monitoring the 2009 H1N1 vaccine’s safety: the Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD).  This report represents the largest, and to date best, evaluation of the 2009 H1N1 vaccine’s safety profile since its initial testing and release.  The findings are reassuring.

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Posted in: Science and Medicine, Science and the Media, Vaccines

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