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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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SANE Vax adopts Dr. Hanan Polansky’s “microcompetition” as its own. Hilarity ensues.

One of the hallmarks of science as it has been practiced for the last century or so is that scientists share their discoveries in the peer-reviewed literature, where their fellow scientists can evaluate them, decide if they’re interesting, and then replicate them, usually as a prelude to building upon them. While the system of publication and peer review in science is anything but perfect (and, indeed, we have discussed many of its shortcomings right here on this very blog), I tend to like to view it in much the same way Winston Churchill characterized democracy:

Many forms of Government have been tried and will be tried in this world of sin and woe. No one pretends that democracy is perfect or all-wise. Indeed, it has been said that democracy is the worst form of government except all those other forms that have been tried from time to time.

I would rephrase this as:

Many forms of evaluating science have been tried and will be tried in this world of sin and woe. No one pretends that peer review is perfect or all-wise. Indeed, it has been said (by me) that peer review is the worst form of evaluating science except all those other forms that have been tried from time to time.

As mainstream medicine has become more scientific over the last century in the wake of the Flexner Report, physicians and medical researchers have similarly come to view publication in the peer-reviewed literature to be a very important component of communicating and evaluating medical discoveries. It’s not as though this is even a particularly high bar to pass, either. After all, many are the absolutely execrable papers that I (and my partners in crime here at SBM) have discussed over the last four years, nearly all of which were in peer-reviewed journals, some very prestigious. After all, if papers on “energy chelation” can find their way into decent journals and the likes of Mark and David Geier can publish in the peer-reviewed literature, while someone like Christopher Shaw can get cringe-worthy confusions of correlation with causation published, I don’t take seriously the whines of cranks who claim that they can’t publish in the peer-reviewed literature for one reason or another.

That’s why I view being published in the peer-reviewed literature as a minimum, but by no means sufficient, requirement good science. It’s also why, whenever I see a new claim, my first reaction is to see if (1) the person making the claim has published on it and (2) there are publications in the peer reviewed literature that support the claim. The first criterion helps me judge whether the person is a serious scientist; the second, whether there is any plausibility to his ideas. Sure, it’s not a foolproof scheme, but it is helpful.

I only wish antivaccinationists would do the same. That they don’t explains why they seem to be embracing someone named Dr. Hanan Polansky.
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Posted in: Basic Science, Cancer, Vaccines

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Bravewell Bimbo Eruptions

This is yet another response to the recent “Integrative Medicine in America” report published by the Bravewell Collaborative. Drs. Novella and Gorski have already given that report its due, so I won’t repeat the background information. Inevitably, I’ll cover some of the same points, but I’ll also try to emphasize a few that stand out to me. Most of these have been discussed on SBM over the years, but bear repeating from time to time. Let’s begin with:

If it Ducks like a Quack…

Misleading language is the sine qua non of ‘integrative medicine’ (IM) and its various synonyms. The term itself is a euphemism, intended to distract the reader from first noticing the quackery that is its distinguishing characteristic. As previously explained, Bravewell darlings Andrew Weil and Ralph Snyderman, quack pitchmen extraordinaires, recognized nearly 10 years ago that if you really want to sell the product, you should dress it up in ways that appeal to a broad market.

Let’s see how this is done in the latest report. Here is the very first sentence:

The impetus for developing and implementing integrative medicine strategies is rooted in the desire to improve patient care.

Who would disagree with improving patient care? (Try not to notice the begged question). Here’s the next paragraph (emphasis added): (more…)

Posted in: History, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine, Science and the Media

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“Obama Promises $156 Million to Alzheimer’s…But where will the money come from?” That’s easy: the NCCAM!

The quoted language above is part of the headline of this story in today’s The Scientist:

Citing the rising tide of Americans with Alzheimer’s—projections suggest 10 million people will be afflicted by 2050—the Obama administration and top National Institutes of Health officials are taking action. On February 7, they announced that they will add an additional $80 million to the 2013 NIH budget for the Alzheimer’s research program.

The problem is that there ain’t no such thing as a free lunch:

However, Richard Hodes, director of the NIH’s National Institute on Aging, told Nature that the 2013 dollars still have to be approved by Congress in the next budget and, if not, existing programs may need to be cut. And this year’s $50 million is likely to bump other projects, perhaps at NIH’s National Human Genome Research Institute. “If there’s a finite budget anywhere, once there’s more of something, there is less of something else,” he said.

Often such budget compromises are difficult, because there is no ready way to choose between two or more competing recipients of taxpayers’ money, each of which might be comparably worthy. Thus it is with a great sense of relief that in this case, we in the biomedical community can assure President Obama that no such dilemma exists. This is one of those occasional decisions that requires no hair-pulling whatsoever. The obvious solution is to defund the National Center for Complementary and Alternative Medicine (NCCAM), which, at about $130 million/yr, would solve the problem of funding Alzheimer’s research and take the heat off other worthy programs such as those mentioned by Richard Hodes.

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Posted in: History, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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