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On the “right” to challenge a medical or scientific consensus

Jenny McCarthy flaunting her "expertise" at the antivaccine "Green Our Vaccines" rally in Washington, DC in 2008

Jenny McCarthy flaunting her “expertise” at the antivaccine “Green Our Vaccines” rally in Washington, DC in 2008

The major theme of the Science-Based Medicine blog is that the application of good science to medicine is the best way to maintain and improve the quality of patient care. Consequently, we spend considerable time dissecting medical treatments based on pseudoscience, bad science, and no science, and trying to prevent their contaminating existing medicine with unscientific claims and treatments. Often these claims and treatments are represented as “challenging” the scientific consensus and end up being presented in the media—or, sadly, sometimes even in the scientific literature—as valid alternatives to existing medicine. Think homeopathy. Think antivaccine views. Think various alternative cancer treatments. When such pseudoscientific medicine is criticized, frequently the reaction from its proponents is to attack “consensus science.” Indeed, I’ve argued that one red flag identifying a crank or a quack is a hostility towards the very concept of a scientific consensus.

Indeed, I even cited as an example of this attitude a Tweet by Jane Orient, MD, executive director of the American Association of Physicians and Surgeons (AAPS). This is an organization of physicians that values “mavericky-ness” above all else, in the process rejecting the scientific consensus that vaccines are safe and effective and do not cause autism or sudden infant death syndrome (SIDS), that HIV causes AIDS, and that abortion doesn’t cause breast cancer, to name a few. Along the way the AAPS embraces some seriously wacky far right wing viewpoints such as that Medicare is unconstitutional and that doctors should not be bound by evidence-based practice guidelines because they are an affront to the primacy of the doctor-patient relationship and—or so it seems to me—the “freedom” of a doctor to do pretty much damned well anything he pleases to treat a patient.
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Posted in: Critical Thinking, Science and the Media, Vaccines

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The Food Babe’s war on “chemicals” heats up again

The Food Babe

[Note: This is an extra bonus post. Because The Food Babe has been in the news and I couldn’t wait until today, I discussed it at a certain not-so-super-secret blog. If you’ve read it before, it’s only somewhat modified and updated. If you haven’t, it’s new to you. Either way, feel free to comment. Completely new material by me will appear here in a scant few hours.]

It’s been a while since I’ve taken notice of Vani Hari, a.k.a. The Food Babe, the misguided “food safety” activist who sees chemicals, chemicals, chemicals everywhere and raises fears about them all, especially the ones that she can’t pronounce. The first time I took any significant notice of her was about a year ago, when she was making news for lobbying Subway to remove the “yoga mat chemical” azodicarbonamide from its bread, although I didn’t write about her here for a few months after that. As I explained at the time, azodicarbonamide is a chemical used in small amounts to mature bread dough, improve its handling properties, and produce a drier, more cohesive, and more pliable dough that holds together better during kneading by hand or machine. It is safe, breaks down during baking into small amounts of safe substances, and is only a hazard if you inhale it in powder form, where it can be a pulmonary irritant. Then, she made some astonishingly ignorant statements about beer, where she pulled the same routine, to the point where I labeled her tactics as the “appeal to yuckiness.” Basically, if something sounds yucky to her (such as isinglass, which is derived from the swim bladders of fish and is used in some beers to remove haziness and yeast byproducts), then it must be bad, either for you or just bad because it’s gross. It also turns out that The Food Babe makes quite a pretty penny spreading her ignorance and has become sought after to feature in various media appearances, such as magazine covers.

For the last few months I’ve been somewhat dreading February, because I knew Hari was poised to release her first book. As I described before, she has more than a fair amount of social media savvy and business acumen, which have allowed her to build the Food Babe brand rapidly and explains (to me at least) why she seemed to come out of nowhere on a trajectory to become as influential as Dr. Mehmet Oz. Her book, released this week, is called The Food Babe Way: Break Free from the Hidden Toxins in Your Food and Lose Weight, Look Years Younger, and Get Healthy in Just 21 Days! (Talk about ridiculously long subtitles!) You see, I knew that when it came time for Hari’s book to come out we’d be seeing a lot more of her, and unfortunately that’s what happened. As part of that publicity, Hari was featured in a fairly long feature article in The Atlantic by James Hamblin, The Food Babe: Enemy of Chemicals. It’s a relatively amusing title, to be sure, and there’s a lot that’s good about the article. Unfortunately, there’s also a lot that’s downright infuriating about it as well, the more so given that Hamblin is a physician and really should know better, but unfortunately in this piece he shows himself far more respectful of pseudoscience of the sort promoted by The Food Babe than a physician should be.
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Posted in: Nutrition, Science and the Media

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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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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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Measles gets a helping hand

In a recent post I shared a bit of my personal, near-death experience with measles during the US epidemic of 1989-1991. As I describe in that post, I contracted a very serious measles infection at the end of medical school, and was highly infectious when I interviewed for a residency position at Seattle Children’s Hospital. Like others my age who received an ineffective, killed measles vaccine between 1963 and 1967, I had not been adequately protected. The MMR vaccine was not yet available, and no boosters were recommended at the time. Unfortunately, though my measles titers (a test of immunity to measles) were checked when I entered medical school, the school’s student health department failed to notice or respond to the results – I was not immune and did not receive a booster dose at that time, as I should have. That mistake was huge, and could have cost me my life. It also caused me to potentially sicken many vulnerable children during my tour of the hospital, as well as others I may have inadvertently exposed during the window of communicability as I walked the streets of Seattle. The Department of Health had to be called to trace all of my steps and attempt to track down and protect any potential contacts.
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Posted in: Epidemiology, Medical Ethics, Politics and Regulation, Public Health, Science and Medicine, Vaccines

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Yes, Chris beat cancer, but it wasn’t quackery that cured him

Editor’s note: Due to technical difficulties, SBM experienced considerable downtime yesterday. I therefore decided to delay publishing this post until now. Harriet’s normally scheduled Tuesday post will also appear later.

I like to think that one of the more important public services I provide here at Science-Based Medicine is my deconstructions of alternative cancer cure testimonials. After all, one of the most powerful marketing tools purveyors of cancer quackery have in their arsenal is a collection of stories of “real patients” with cancer who used their nostrums and are still alive and well. These sorts of analyses of alternative cancer cure testimonials began right near the very beginning of my not-so-super-secret other blog way back in 2004, metastasized—if you’ll excuse my use of the term—to SBM in 2008, and have continued intermittently to this very day, most recently with a bevy of posts showing why the testimonials of Stanislaw Burzynski’s patients do not constitute good evidence that he can cure cancers considered incurable by “standard” medicine. In other words, Burzynski’s “success stories” aren’t the slam-dunk evidence he and Eric Merola want you to believe them to be regarding the use of antineoplastons to cure brain cancers.

Sometimes, these patients who believe that alternative medicine somehow cured their cancers are so transformed, so energized, that they basically devote their lives to selling, in essence, their story, along with all the stuff they did to “cure” their cancer. I just came across one such person, a man by the name of Chris Wark, whose website and blog Chris Beat Cancer sells the idea that he beat his cancer with nutrition and “natural therapies” that he used to “heal himself.” All of this wouldn’t be quite so horrible—after all, there are lots of people who believe in woo and say so publicly—except that Wark is now also selling all sorts of misinformation about cancer, at $175 for a two hour phone consultation. Regular readers will recognize right away where Mr. Wark goes wrong in his story. Even so, I think it’s worthwhile to take a look because since discovering Mr. Wark’s site I’ve seen his name popping up all over the place promoting “natural” cures, and his site has become a repository of all sorts of “alternative cancer cure” testimonials, as well as credulously promotional material for quackery like Gerson therapy, the Beck protocol, and the Gonzalez protocol.

First, let’s take a look at Mr. Wark’s story. Since his story is so simple to deconstruct, I’ll then look at more of the material on his website. Right on the front page of Mr. Wark’s website, there is a brief blurb about him that reads:
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Posted in: Cancer

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ASEA: Another Expensive Way to Buy Water

ASEA is a diet supplement described as a “life-changing” health aid that can benefit everyone.

“ASEA is trillions of stable, perfectly balanced Redox Signaling Molecules suspended in a pristine saline solution—the same molecules that exist in the cells of the human body. Redox signaling is a function that is central to all life. Signaling molecules are created within every cell in the body. After the age of 12, our cells make fewer and fewer of these molecules. ASEA is the world’s only source for replenishing them.”

ASEA allegedly:

  • Promotes enhanced immune function
  • Supports the vital activity of cellular communication
  • Provides superior “support” to athletes
  • Boosts efficiency of the body’s own antioxidants by 500%
  • Protects against free radical damage

ASEA doesn’t (can’t legally) claim to be effective for any disease, but since a number of diseases are related to immune function, free radical damage, etc., it’s only natural to assume that ASEA would benefit a host of conditions. The claims are deliberately vague, and there is the usual disclaimer that it has not been evaluated by the FDA and is not intended to treat or prevent any disease; but testimonials and innuendo suggest all kinds of specific benefits ranging from better sleep to cancer.

What’s in this miracle product? The ingredients are listed on the label: water and salt.

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Posted in: Herbs & Supplements

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Steve Novella vs. Julian Whitaker on vaccines at FreedomFest

Steve Novella vs. Julian Whitaker on vaccines at FreedomFest

I’ve just returned from TAM, along with Steve Novella and Harriet Hall. While there, we joined up with Rachael Dunlop to do what has become a yearly feature of TAM, the Science-Based Medicine workshop, as well as a panel discussion on one of our favorite subjects, “integrative” medicine. Between it all, I did the usual TAM thing, meeting up with old friends, taking in some talks, and, of course, spending the evenings imbibing more alcohol than I probably should have so that I could look and feel my best for our morning sessions, particularly given my difficulty adapting to the time change. One thing I did was completely unexpected, something I learned about the night before our workshop when I happened to run into Evan Bernstein. He informed me of something that our fearless leader Steve Novella was going to do the next day right after our workshop. In a nutshell, Evan told me that Steve was going to debate an antivaccinationist. Evan didn’t know any details other than that Michael Shermer had arranged it and that Steve had been tapped at the last minute. Evan didn’t even know who the antivaccinationist was going to be or what the event was. Naturally, I was intrigued.

So, the next morning I asked Steve about it. I turns out that the event was FreedomFest, a right-wing/Libertarian confab that happened to be going on at the same time as TAM up the road a piece on the Strip at Bally’s. Steve didn’t know who the antivaccinationist was going to be either, which made me marvel at him. I don’t know that I’d have the confidence agree to walk into the lion’s den with less than a day’s notice not even knowing who my opponent is. Steve was more than happy to invite me along. Clearly, this was was an opportunity that I couldn’t resist. So we met up with Michael Shermer, and it was from him that I learned that Steve’s opponent was to be Dr. Julian Whitaker.

My eyes lit up.
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Posted in: Neuroscience/Mental Health, Politics and Regulation, Vaccines

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Foolishness or Fraud? Bogus Science at NCCAM

Voodoo science is a sort of background noise, annoying but rarely rising to a level that seriously interferes with genuine scientific discourse… The more serious threat is to the public, which is not often in a position to judge which claims are real and which are voodoo. Those who are fortunate enough to have chosen science as a career have an obligation to inform the public about voodoo science.

– Robert L. Park, PhD, 20001

Imagine you are an ordinary person with limited knowledge of science and medicine, and you see this 2010 video on tai chi and qi gong by the National Center for Complementary and Alternative Medicine (NCCAM) — one of the agencies that make up the National Institutes of Health (NIH). I am certain that the solemn voice of the Director of NCCAM, Dr. Josephine Briggs, talking about “rigorous scientific research” and “accurate, authoritative information on complementary and alternative medicine,” will leave you with a strong sense of confidence in her message.

In addition, despite the fine-print and the disclaimer, the appearance of Dr. Briggs in the video could be broadly viewed as a sign of tacit endorsement. Often, the very fact that a treatment is associated with the government is already a de facto stamp of approval and a warranty of efficacy. For instance, the publication below by the California Department of Consumer Affairs states that the NIH formally “endorses” acupuncture, simply because in 1997, a panel of scientists assessed its use and effectiveness for a variety of conditions. Since 1997 the scientific review of acupuncture by NIH has become synonymous with its endorsement, despite the fact that as a federal research agency, the NIH does not endorse any product, service, or treatment.

In October 26, 2011, a few weeks after Steve Jobs’ death, Josephine Briggs decided to do something she has never done before: she put an explicit disclaimer on her blog:

When making treatment decisions, unproven “alternative medicine” approaches should not replace conventional medical care approaches known to be useful or helpful. Simply put, the evidence is not there (emphasis added).2

Three paragraphs down the page, she goes on — with a candor rarely seen from her — that given the recent news about Steve Jobs’ choices for cancer treatment, all health decisions “should be guided by the best available evidence.”
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Posted in: Acupuncture, Basic Science, Health Fraud, Politics and Regulation, Public Health, Science and Medicine

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Update: Homeopathy in Brazilian Scientific American

Last week I wrote about a regrettable piece on homeopathy that was published in Scientific American Brasil.  There have been gratifying developments. Within hours, the editor in chief of Scientific American, Mariette DiChristina, appeared in the Comments. She said that Scientific American does not condone the pseudoscience of homeopathy, that the piece clearly should not have been published, that it would never have been published if Scientific American had been consulted beforehand, and that she had complained to the responsible parties. I was very grateful for her response to my article, for her intervention, and for her willingness to speak out in support of good science.

An Apology

Lo and behold, two days later Ms. DiChristina reported that the editor of Scientific American Brasil had written a letter of apology and had published it on the website. Here is a full translation:

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Posted in: Homeopathy, Science and the Media

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