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Andrew Wakefield, the MMR, and a “mother warrior’s” fabricated vaccine injury story

AWakefield

As the time came to do my usual weekly post for this blog, I was torn over what to write about. Regular readers might have noticed that a certain dubious cancer doctor about whom I’ve written twice before has been agitating in the comments for me to pay attention to him, after having sent more e-mails to me and various deans at my medical school “challenging” me to publish a link to his results and threatening to go to the local press to see if he can drum up interest in this “battle.” I’ve been assiduously ignoring him, but over time the irritation factor made me want to tell him, “Be very careful what you ask for. You might just get it.” Then I’d make this week’s post about him, even though I wasn’t thrilled with the idea of giving in to his harassment and giving him what he wants.

That’s why I have to thank the ever-intrepid investigative reporter Brian Deer for providing me an alternative topic that is way more important than some self-important little quack and a compelling topic to blog about in its own right. Brian Deer, as you might recall, remains the one journalist who was able to crack the facade of seeming scientific legitimacy built up by antivaccine guru Andrew Wakefield and demonstrate that (1) Wakefield’s work concluding that the MMR vaccine was associated with “autistic enterocolitis” was bought and paid for by a solicitor named Richard Barr, who represented British parents looking to sue vaccine manufacturers, to the tune of over £400,000; (2) Wakefield expected to make over £72 million a year selling a test for which Wakefield had filed a patent application in March 1995 claiming that “Crohn’s disease or ulcerative colitis may be diagnosed by detecting measles virus in bowel tissue, bowel products or body fluids”; and Wakefield’s case series published in The Lancet in 1998 was fraudulent, the equivalent of what Deer correctly characterized as “Piltdown medicine.” Ultimately, these revelations led to Wakefield’s being completely discredited to the point where The Lancet retracted his paper and even Thoughtful House, the autism quackery clinic in Austin, TX where Wakefield had a cushy, well-paid position as scientific director, had to give him the boot. Yes, Wakefield is a fraud, and it’s only a shame that it took over a decade for it to be demonstrated.

As much as I hate how it took discrediting Wakefield the man as a fraud rather than just discrediting his bogus science to really begin to turn the tide against the annoying propensity of journalists to look to Wakefield or his acolytes for “equal time” and “balance” whenever stories about autism and vaccines reared their ugly heads, I can’t argue with the results. Wakefield is well and truly discredited now, so much so that, as I noted, his prominent involvement probably ruined any chance promoters of the “CDC whistleblower” scam ever had to get any traction from the mainstream press.

What is sometimes forgotten is the effect Wakefield’s message has had on parents. These are the sorts of parents who tend to congregate into groups designed to promote the idea that vaccines are dangerous and cause autism, such as the bloggers at the antivaccine crank blog Age of Autism, the equally cranky blog The Thinking Moms’ Revolution, or groups like The Canary Party. It is Wakefield’s message and the “autism biomed” quackery that it spawned that have led to unknown numbers of autistic children being subjected to the rankest form of quackery in order to “recover” them, up to and including dubious stem cell therapies and bleach enemas.
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Posted in: Health Fraud, Homeopathy, Neuroscience/Mental Health, Vaccines

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The “CDC whistleblower saga”: Updates, backlash, and (I hope) a wrap-up

Vaccinefear

Given that this is a holiday weekend here in the US and that I’m having a bit of a staycation right now, I had thought of simply not posting today or of rerunning a “classic” (if you want to call it that) blast from the past. But the topic I wrote about last week has only festered and grown bigger since Monday; so at the very least I felt obligated to do a post updating you, our readers, on the twists and turns that have occurred in the saga of the so-called “CDC whistleblower.” For those of you familiar with the story (not to mention following my not-so-secret other blog), much of this will be familiar, but, given that this is SBM, I felt that this material should be on record here for your edification and (hopefully) education. I’ll take (more or less) a chronological approach since last Monday and then finish up by trying to put this whole mess into perspective. This is going to be longer than even my usual posts, but I want to be authoritative. So, if you’re very familiar with what’s happened, you might want to skim everything before the “backlash” and “conclusion” sections to fill in what you might have missed. If you’re less than completely steeped in what happened, read every scintillating word!

But first, for those who might be entering this saga right now, let me recap a moment. I’m referring to a conspiracy theory, which has been flogged to death by the antivaccine movement for nearly two weeks now, that there is a CDC whistleblower who has made “devastating” reports that the CDC hid data that showed a 3.4-fold increased risk of autism in African American males, based on an incompetent “reanalysis” of a 10 year old CDC study that found no evidence that children with autism were more likely to have received their first MMR vaccine earlier than neurotypical controls. As I (and others) have discussed, Hooker used howlingly bad statistical methodology (for instance, analyzing case control data as a cohort study and using risibly bad statistical analyses) to torture the data until they confess that vaccines cause autism. As I said at the time, when it comes to data, call Hooker the Spanish Inquisition. Such was the weakness of what he found that, even after forcing the data to sit in the comfy chair for extended periods of time, the most damning “confession” he could get from them was a correlation between age at MMR vaccination and autism diagnoses in one small subgroup: African American males.

Based on this utterly incompetent data torture and Hooker’s apparent budding relationship with a “CDC whistleblower,” Wakefield first made a video in which this “whistleblower’s” voice was electronically altered (not to mention edited into such selective snippets that it was impossible to glean any context from his seemingly-damning statements. This video, released through Andrew Wakefield’s and Tommy Polley’s Autism Media Channel, despicably likened this CDC “cover-up” to the Tuskegee syphilis study, and finished with a flourish of Godwin-y nonsense that included Adolf Hitler (of course!), Pol Pot, and Josef Stalin, implying that the CDC’s “crimes” with respect to this alleged cover-up were just as bad. It was a breathtaking demonstration of pure stupid hyperbole. Then, a few days later, Wakefield replaced the video with the alterations in the “whistleblower’s” voice with his real voice and revealed his real name: William W. Thompson, PhD, a psychologist and senior scientist at the CDC, as well as a co-author of the study being “reanalyzed,” DeStefano et al. Now, on to the update! (more…)

Posted in: Science and the Media, Vaccines

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Ebola outbreaks: Science versus fear mongering and quackery

Ebola virus particles.jpg
Ebola virus particles” by Thomas W. Geisbert, Boston University School of Medicine – PLoS Pathogens, November 2008 doi:10.1371/journal.ppat.1000225. Licensed under CC BY 2.5 via Wikimedia Commons.

Without a doubt the big medical story of the last week or so has been the ongoing outbreak of Ebola virus disease in West Africa, the most deadly in history thus far. Indeed, as of this writing, according to a table of known Ebola outbreaks since 1976 at Wikipedia, in Guinea, Sierra Leone, and Liberia, the three nations affected thus far, there have been 1,440 cases and 826 deaths. Worse, the World Health Organization (WHO) is reporting that it is spreading faster in Africa than efforts to control it. In particular, late last week it was announced that two Americans who had been infected with Ebola were going to be flown back to the US, specifically to Emory University, for treatment, a development that ramped up the fear and misinformation about Ebola virus to even greater heights than it had already attained, which, unfortunately, were already pretty high. Indeed, the ever-reliably-histrionic Mike Adams of NaturalNews.com wrote a typically hysterical article “Infected Ebola patient being flown to Atlanta: Are health authorities risking a U.S. outbreak?” On Saturday, we learned that Dr. Kent Brantly, an aide worker for Samaritan’s Purse, a Christian charity run by Franklin Graham, son of the well-known preacher, Billy Graham, who had been evacuated from Liberia aboard a private air ambulance, had arrived in Georgia.

This latest development inspired medical “experts,” such as Donald Trump, to stoke fear based on the arrival of two infected Americans in the US. For instance, last Friday, after it was first announced that the Ebola-infected Americans would be flown back to the US, Trump tweeted:

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Posted in: Epidemiology, Health Fraud, Homeopathy, Public Health, Vaccines

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Dr. Frank Arguello’s “atavistic oncology”: Another dubious cancer therapy to be avoided

EDITOR’S NOTE: Dr. Arguello has responded. See his response and my reply here.

Not infrequently, I’m asked why it is that I do what I do. Why do I spend so many hours of my free time, both here and at my not-so-super-secret other blog (NSSSOB), to write my detailed analyses of various forms of quackery, analyses of scientific studies, and expressions of my dismay at the infiltration of pseudoscience into medicine, particularly medical academia in a phenomenon I like to call “quackademic medicine”? One reason, of course, is because I passionately believe in what I am doing. Another reason is that I want information countering various forms of dubious medicine to be out there, and I have two well-trafficked blogs as a platform, although SBM long ago surpassed my NSSSOB in traffic and reach.

Over the last six years, there are some topics that I’ve written about many times, such as the antivaccine movement, Stanislaw Burzynski, cancer quackery, and common myths about cancer treatment. Surprisingly, there are some topics left that I should have written about a long time ago but haven’t, even though I had heard of them before. One such topic, atavistic oncology and chemotherapy, was brought to my attention a couple of weeks ago by a reader, who basically pointed me to a particular dubious bit of cancer treatment whose chief proponent, Dr. Frank Arguello, is apparently currently touring Canada to do conferences and meet with potential patients, placing ads in local newspapers in the cities in which he will be appearing. His meeting with patients in Canada seems particularly problematic, because his cancer practice is located in San Jose del Cabo, Baja California Sur, Mexico, a location that, given the nature of his practice and claims, struck me as remarkable only because it’s not Tijuana. In any case, Dr. Arguello just appeared in Saskatoon on Friday and is scheduled to appear in Regina on July 30, with appearances in Winnipeg, Vancouver, Calgary, Edmonton, and Toronto promised in the future, as well as U.S. appearances in San Francisco and Los Angeles. Specifically, after his appearance in Regina, advertised here:

ArguelloRegina

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Posted in: Cancer, Health Fraud

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Of the Trial to Assess Chelation Therapy, Bayes, the NIH, and Human Studies Ethics

An experiment is ethical or not at its inception; it does not become ethical post hoc—ends do not justify means.
~ Henry K. Beecher

tact

A couple of weeks ago, Dr. Josephine Briggs, the Director of the National Center for Complementary and Alternative Medicine (NCCAM), posted a short essay on the NCCAM Research Blog touting the results of the Trial to Assess Chelation Therapy (TACT) (italics added):

The authors found that those receiving the active treatment clearly fared better than those receiving placebo. The accompanying editorial in the AHJ reminds readers about the value of equipoise and the need to “test our beliefs against evidence.”

Most physicians did not expect benefit from chelation treatment for cardiovascular disease. I readily admit, initially, I also did not expect we would find evidence that these treatments reduce heart attack, strokes, or death. So, the evidence of benefit coming from analyses of the TACT trial has been a surprise to many of us. The subgroup analyses are suggesting sizable benefit for diabetic patients—and also, importantly, no benefit for the non-diabetic patient. Clearly subgroup analyses, even if prespecified, do not give us the final answer. But it is also clear that more research is needed to test these important findings.

And TACT findings are indeed a reminder of the importance of retaining equipoise [sic], seeking further research aimed at replicating the findings, and neither accepting nor rejecting findings based on personal biases. The scientific process is designed to weed out our preconceived notions and replace them with evidence.

Dr. Briggs concluded:

So, TACT is a reminder—an open mind is at the center of the scientific method.

Dr. Briggs’s title was “Bayes’ Rule and Being Ready To Change Our Minds”, a reference to a recent editorial that had accompanied one of the TACT papers. That editorial, by Dr. Sanjay Kaul, a physician and statistician from UCLA, begins with this quotation:

Preconceived notions are the locks on the door to wisdom.
~ Merry Browne

Here is the relevant passage from Dr. Kaul’s editorial (italics added):

Sixth, it has been argued that the trial was unethical because there was no compelling clinical or preclinical evidence that chelation therapy has significant efficacy against atherosclerotic cardiovascular disease, and given that chelation therapy can cause harm, the risk was not minimal. A Bayesian analysis would not look kindly on the results because of the low prior probability of treatment effect (the so-called implausibility argument).6 This is an uncharitable (and unwarranted) interpretation of the data because previous systematic reviews concluded, “insufficient evidence to decide on the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes among people with atherosclerotic cardiovascular disease.” It is axiomatic that absence of evidence of efficacy is not the same as evidence of the absence of efficacy.

From a Bayesian perspective, the strength of evidence is often summarized using a Bayes factor, which is a measure of how well 2 competing hypotheses (the null and the alternate) predict the data. The Bayes factor and the corresponding strength of evidence for the primary end point result in TACT overall, and diabetic cohorts are shown in Table 1. The p-value of 0.035 for TACT overall cohort translates into a Bayes factor of 0.108, which means the evidence supports the null hypothesis ≈1/9th as strongly as it does the alternative. This reduces the null probability from 50% pretrial (justified by suspension of one’s belief in treatment effect) to 10% post-trial. Although this does not represent strong evidence against the null, it does reduce the level of skepticism surrounding chelation therapy. In the diabetic cohort, the nominal p-value of 0.0002 translates into a Bayes factor of 0.002 (1/500), which reduces the extremely skeptical prior null probability of 95% to 4% post- trial, indicating very strong evidence against the null.

In concluding, Dr. Kaul states:

Finally, TACT highlights the double standard when it comes to accepting inconvenient results not aligned with our preconceived notions on so-called dubious quack cures such as chelation…

Closed minds?

Dr. Kaul’s reference “6” above is to a lengthy article that we published in 2008 titled “Why the NIH Trial to Assess Chelation Therapy Should Be Abandoned”. So, it seems, both Drs. Briggs and Kaul were chastising us for our biased, preconceived beliefs about so-called dubious quack cures. Our minds were, apparently, not open. Let’s examine this contention. (more…)

Posted in: Clinical Trials, Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation

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Beware the Integrative Pharmacy

pharmacy window

Imagine a retail pharmacy where some of the medicines on the shelves have been replaced with similar-looking packages that contain no active ingredients at all. There is no easy way to distinguish between the real and the fake.

Another section of the store offers a number of remedies with fantastic claims, such as “boosting” the immune system, “detoxifying” the body, or “cleansing” you of microscopic Candida. They look sciencey, unless you realize that they treat imaginary medical conditions.

A corner of the store offers unpurified drugs supplied as tinctures and teas. The active ingredients aren’t known, and the batch-to-batch consistency of the product is unclear. The store will suggest products for you based on your symptoms.

Walk past the enormous wall of vitamins and other supplements and you’ll find a nutritionist who will tell you what products you should be taking. You’ll also find a weight loss section. From a science-based perspective, this shouldn’t even exist, given no product has been shown to offer any meaningful benefit. But there are dozens of products for sale.

At the back of the store you’ll finally find the pharmacist. A sign on the counter offers blood- and saliva-based tests for food “intolerance” and adrenal “fatigue”, claiming to test for medical conditions that actually don’t exist or lack an evidence base. The pharmacy also offers a large compounding practice, advertising what it calls “personalized” approaches to hormone replacement with “bioidentical” hormones.

Welcome to the “integrative” pharmacy.

You may not see all these features in your local drug store, but they’re coming: claims of a new “integrative” way to provide health care that is changing the face of retail pharmacy. Unfortunately, it’s harkening back to the era of patent medicines and snake oil. It’s not good for the pharmacists and the profession of pharmacy, and it’s even worse for patients. (more…)

Posted in: Homeopathy, Medical Ethics, Politics and Regulation, Science and Medicine

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Dr. Joe Writes About Quackery

Not long ago I wrote about the free online “Food for Thought” course. Joe Schwarcz (“Dr. Joe”) was one of the three professors teaching that course. He also has a radio show, a blog, a podcast, and he writes books. His newest book will be of particular interest to SBM readers: Is That a Fact? Frauds, Quacks, and the Real Science of Everyday Life.

dr-hoe-is-that-a-fact

I reviewed an earlier book of his, The Right Chemistry, for Skeptic magazine. You can read my review online here. I called him “The Carl Sagan of Chemistry” for his ability to popularize science and make it not only palatable but fascinating and entertaining. In the new book, Dr. Joe turns his attention to exactly the kind of subjects we cover on this blog. He is a chemist and most of us are physicians, but we reach the same conclusions because we look at the evidence from the same rigorous scientific viewpoint.

In The Right Chemistry, Dr. Joe explains that “chemical” does not mean “bad stuff” — chemicals make up the entire world, and we are made of chemicals that our own body manufactures. He shares his encyclopedic store of obscure and intriguing scientific facts. Have you ever heard of kangatarians? Did you know asparagus can grow up to 10 inches a day? Can you explain why crystals of Epsom salts crumble if you yell at them? Do you think explosives can’t be made on a plane with small amounts of liquids? (Dr. Joe thinks they can, but for obvious reasons he’s not divulging the recipe.) You probably didn’t know that in World War II the U.S. military developed a mixture called “Who Me?” that smelled like feces and was dispensed with an atomizer. French Resistance fighters were supposed to surreptitiously spray it on German officers to embarrass them, but it wasn’t a great success since the sprayer ended up as stinky as the sprayee.
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Posted in: Book & movie reviews

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Naturopathy vs. Science: Vaccination Edition

evil-mr-vaccine

We saw it coming. The re-emergence of vaccine-preventable disease should surprise no-one that’s been following the anti-vaccine movement.

Rebutting anti-vaccine rhetoric feels like a Sisyphean struggle. Steven Novella likened it to a game of whack-a-mole, where the moles are the same old tropes that keep popping up, no matter how often they are refuted with facts. Vaccines are a remarkable success of modern medicine: They are health interventions that are both demonstrably effective and remarkably cost-effective. Vaccination has likely prevented more deaths in the past 50 years than any other health intervention. Smallpox was a ruthless killer that took 300 million lives, just in the 20th century alone. Today it’s gone – eliminated forever. And now there are now over two dozen diseases that are vaccine-preventable. They should be an easy sell, and to most people, they are. But the control of vaccine-preventable disease relies in part on herd immunity – sufficient immunization to stop the spread of infection (no vaccine offers 100% protection) and protect those that cannot be immunized. Even a modest number of unvaccinated individuals can lead to reemergence of disease. None of this matters to antivaccinationists, to whom vaccines are bad. Viewing anti-vaccine websites for only five to ten minutes can increase the perception of risk of vaccination, and decrease the perceived risk of omitting vaccines. It also lowers vaccination intentions. By changing perceptions of safety, the willingness to vaccinate decreases. Now imagine that someone you believe to be a health professional openly questioned the efficacy and safety of vaccines – would it reduce your willingness to vaccinate? The evidence says it does. And that’s why the modern practice of naturopathy or “naturopathic medicine” is so concerning. Naturopaths have opposed vaccinations since the invention of naturopathy – starting with smallpox: (more…)

Posted in: Naturopathy, Vaccines

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pH Miracle Living “Dr.” Robert O. Young is finally arrested, but will it stop him?

pH Miracle Living “Dr.” Robert O. Young is finally arrested, but will it stop him?

Being a cancer surgeon and researcher, naturally I tend to write about cancer a lot more than other areas of medicine and science. It’s what I know best. Also, cancer is a very common area for unscientific practices to insinuate themselves, something that’s been true for a very long time. The ideas don’t change very rapidly, either. Drop a cancer quack from 2014 into 1979, and he would probably be right at home. Of course, part of the reason is because the “elder statesmen” of cancer quackery today were getting their starts in 1979. Still, the same ideas keep recurring even as far back as a century ago and even older, and if you broaden your criteria, these ideas exist on a continuum, either having descended directly from various ancient ideas such as vitalism, miasmas, or humoral theory or branched off somewhere along the way. Others branch off from the progress of science, taking a germ of a seemingly reasonable idea and turning it into quackery. It is the latter with which I plan on concerning myself today, the reason being that over the weekend I heard some truly awesome news. One of the most egregiously practicing non-physicians who claim to be able to cure cancer that I’ve ever encountered was arrested—yes, arrested!—and arraigned on criminal charges. I’m referring to “Dr. Alkaline” himself, he of the pH Miracle Living program and his Articles of Health blog, “Dr.” Robert O. Young. Behold:
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Posted in: Cancer, Naturopathy, Politics and Regulation

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“Low T”: The triumph of marketing over science

A man on TV is selling me a miracle cure that will keep me young forever. It’s called Androgel…for treating something called Low T, a pharmaceutical company–recognized condition affecting millions of men with low testosterone, previously known as getting older.

The Colbert Report, December 2012

 

And now for something completely different…sort of.

After writing so much about the latest developments in the ongoing saga of the cancer doctor who is not an oncologist and not a legitimate cancer researcher, plus a rumination on what’s up with President Obama’s nominee for Surgeon General and our favorite form of unscientific medicine, so-called complementary and alternative medicine (CAM), also known as “integrative medicine,” I thought it was time for a change of pace. I wasn’t sure what I was going to write about as Sunday rolled around, but fortunately, as sometimes happens, the New York Times dropped a topic right in my lap, so to speak, both figuratively and literally. It comes in the form of a long article on something that directly concerns men of a certain age, which unfortunately happens to mean men of my age and older. I’m referring to what pharmaceutical company advertising campaigns have dubbed “low T,” short for low testosterone. It’s not clear how the term “low T” originated but Dr. Abraham Morgentaler, founder of Men’s Health Boston, claims to have coined the term when his patients were embarrassed by their difficulty pronouncing the word “testosterone.” Other sources report that it was Solvay Pharmaceuticals that coined the phrase. It doesn’t really matter where the term “low T” came from. The term has stuck, even though the more “correct” medical term would be hypogonadism, as in a man’s testes not working.
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Posted in: Clinical Trials, Diagnostic tests & procedures, Pharmaceuticals, Science and the Media

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