…and in so doing, President Obama, you and we would abolish the NIH’s second most prodigious squanderer of precious research funds! Surprise: The National Cancer Institute (NCI) spends slightly more on humbug than does the Center created for that purpose. All told, the NIH squanders almost 1/3 of a billion dollars per year promoting pseudoscience.

I’ve decided to add my two cents to the recent groundswell of demand to stop this sordid and embarrassing chapter in NIH history—even more sordid and embarrassing, in its way, than NIH researchers being on the take: pseudoscience is exactly antithetical to the mission of the NIH, which sponsors it repeatedly, officially, overtly, unethically, and dangerously. At least, in the case of Big Pharma greasing the palms of NIH researchers, those involved generally prefer to obscure the transactions, as good sense and traditional mores dictate.

My comments will be somewhat different from others’, not because I disagree with theirs but because it’s worthwhile to stress points that have not been stressed or even mentioned. I won’t bother to justify the assertion that “promoting pseudoscience” is an accurate description of what the NCCAM and the OCCAM do, because I’ve done that several times in the past, beginning here and here, and more recently here. I will plagiarize myself a bit, but only to introduce certain points.

A Brief Reminder about Prior Probability

In a nutshell:

Well-intentioned academic physicians often contend that the problem with many “alternative medicine” practices is that they have not been adequately studied. To them it seems clear that controlled trials are the key to determining the efficacy of homeopathy, “distant healing,” “applied kinesiology,” and other claims. But is this really true? These claims are so implausible that to study them is a bad idea. It is bad science because the prior probability of their being correct is very close to zero; hence equivocal results—which are entirely expected in such cases—are paradoxically viewed as implying efficacy or, at least, the need for more (equivocal) studies, on ad infinitum. It is bad public policy because it gives a scientifically-naïve citizenry the misleading impression that legitimate scientists think such claims have merit, thus encouraging health fraud and waste. It is bad ethics because it wastes resources and exploits human subjects.

An acknowledgment of prior probability, which includes biological and physical plausibility in its calculus, is a necessary part of “doing” science and interpreting data—even if Bayesian inference is not formally employed. The failure of Evidence-Based Medicine (EBM) to recognize that plausibility is a necessary, even if insufficient basis for judging therapeutic hypotheses, is an important reason that many physicians and clinical researchers are, however reluctantly, willing to give a pass to the research agenda of the NCCAM and the OCCAM. A more complete discussion of this point can be found in these 4 posts: 1, 2, 3, 4.

A Commitment to Pseudoscience Encourages Dishonesty

In the summer of 2006, two academics, Donald M. Marcus and Arthur P. Grollman, published a critique of the NCCAM in Science. They cited the political impetus for the Center’s agenda, the unlikelihood that negative trials of popular herbal medicines would change the minds of users, the folly of trying to perform “chromatographic analysis of [plant] extracts and of their putative active ingredients” when “the number and identity of the active ingredients of most herbal remedies are unknown,” and the obvious problem of having review panels stacked with pro-“CAM” members. They discussed two NCCAM-sponsored trials in particular:

Two clinical trials supported by NCCAM deserve comment. In collaboration with the National Heart, Lung, and Blood Institute, NCCAM is funding a 5-year $30 million trial of EDTA (ethylenediaminetetraacetic acid) chelation therapy for coronary artery disease. It is being carried out at more than 100 sites and involves over 2300 patients. The justification for this study is that many patients are receiving chelation therapy, although it is not approved by the FDA and off-label use for treating heart disease is currently illegal. The American Heart Association and other national medical organizations have issued statements concerning the lack of evidence for its benefit, and smaller controlled trials have found chelation therapy to be ineffective. Will another negative trial modify the practice of individuals who choose to ignore existing negative evidence and risk legal sanctions?

Another clinical trial compares the use of the chemotherapeutic agent gemcitabine with the Gonzalez regimen in patients with stages II to IV pancreatic cancer. The beliefs that underlie this regimen are that cancer is caused by a deficiency of pancreatic proteolytic enzymes that would normally eliminate cancer cells and their toxic products, and that environmental toxins cause imbalances in the body that lead to cancer. Patients are treated with porcine pancreatic enzymes, coffee enemas twice daily, and nutritional supplementation that includes Papaya Plus, vitamins, minerals, “animal glandular products,” and other products four times daily. Severe adverse effects have been associated with the Gonzalez regimen.

Two important criteria used by scientific review groups to evaluate grant proposals are scientific plausibility and promising preliminary data. No evidence in peer-reviewed journals supports either the plausibility or the efficacy of chelation therapy or the Gonzalez protocol. We believe that funding these projects confers undeserved legitimacy on alternative practices and reflects poorly on the NIH review process.

Marcus and Grollman called for “an independent panel of scientists to review NCCAM.”

Science had invited NCCAM Director Straus to offer a rebuttal, which was published in the same issue. Written with Margaret Chesney, it was the epitome of evasion, misrepresentation, and language distortion. I will mention only a few examples. First, misrepresentation:

The criticism that only a handful of individuals have shaped the NCCAM agenda is not accurate.

All members of NIH peer-review panels and advisory councils, including those at NCCAM, adhere to NIH policies concerning conflict of interest.

The safety of individuals participating in NCCAM-supported clinical studies is of paramount importance to the center.

NCCAM is applying the same scientific standards to the conduct of research and its review as used by other NIH institutes.

Next, evasion:

No mention of the two trials—the chelation trial and the Gonzalez trial—named by Marcus and Grollman as especially deserving of comment. Why is that so important? Because those trials, especially the chelation trial—the largest and most expensive, by far, yet funded by the NCCAM—demonstrate the prevarication of the four statements quoted above. Documentation is here, here, here, here, here, and here. It is galling is to realize, in retrospect, that Straus must have known that the Columbia Data and Safety Monitoring Committee had stopped the Gonzalez trial months before, almost certainly because the regimen had been shown to be vastly inferior to standard treatment. Why didn’t he mention that? A rhetorical question, you may presume, but we know the answer. At a meeting of the Cancer Advisory Panel for Complementary and Alternative Medicine (CAPCAM) in 2001, referring to the Gonzalez trial, Straus had said:

Our ability to reach out and be open-minded about alternative therapies is constantly impugned by traditional medicine and others. We must press on, because this is groundbreaking and important.

In subsequent posts: More misrepresentations in the essay by Straus and Chesney, including their assertion that the NCCAM “brings reliable information to the public”; discussion of a subsequent letter to Science in support of Straus and Chesney, written by several conspicuous “CAM” proponents in medical schools, full of misrepresentations of its own; more discussion of unethical trials sponsored by the NCCAM, and of the central ethical fallacy involved; a bibliography of previous critiques of the NCCAM and of its predecessor, the Office of Alternative Medicine (OAM).



Posted by Kimball Atwood