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Yes We Can! We Can Abolish the NCCAM!

…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 in: Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

Leave a Comment (30) ↓

30 thoughts on “Yes We Can! We Can Abolish the NCCAM!

  1. Ex-drone says:

    Straus writes:

    “We must press on, because this is groundbreaking and important.”

    You can break ground in order to lay a foundation, but you can only construct a building if you have adequate material. Otherwise, you end up digging a pit. Perhaps even a money pit.

  2. This is a great post!!! I look forward to further stuff! (pre-coffee, me no eloquent)

  3. David Gorski says:

    Hmmm. I was going to post on this topic again on Monday. Should I bother?

  4. Jurjen S. says:

    “Our ability to reach out and be open-minded about alternative therapies is constantly impugned by traditional medicine and others.”

    That should probably read something like:

    “Our ability to reach out and be open-minded about alternative therapies is constantly distracted by science-based medical practicioners pointing out that we consistently fail to show any positive and replicable results.”

  5. David, I’m personally up for hearing from ALL the Science-Based Medicine bloggers, in just as much detail as you all care to go into, on why NCCAM/OCCAM should be defunded! The topic makes me happy. More posting equals more awareness of the issue floating around the intranets, and perhaps increased likelihood of people finding the posts and taking an interest in the issue.

  6. maus says:

    “Hmmm. I was going to post on this topic again on Monday. Should I bother?”

    Let the non-industry citizens know what WE can do, who to contact, and the most effective channel for complaint. I think the science-blogs could be very effective at combatting CAM lobbyists if we start early and don’t give up.

  7. mandydax says:

    Signed. All of the SBM bloggers should keep at this. SBM is a great collection of posts that show why the NCCAM is a waste of resources and, even worse, a tool used by CAM practitioners to lend credence to their quackery. I’m going to send a message to the President encouraging him to read this and other posts. He wants to use science to the benefit of all our citizens; he needs to understand the facts, and I can think of no better brain-trust than SBM.

  8. Dr Benway says:

    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 occurs to me that I might use the issue of prior probability in more contexts.

    When parents ask me to read some awful alt.med book, I agree to have a look. I want to bend over backwards to demonstrate that I’m concerned with evidence, not arguments from authority. But the effort is time consuming. The books make nutrition claims, biochem claims, epidemiological claims, etc. –all outside my specialty. So I have to review things I’ve forgotten, then I’ve got to track down the papers behind the novel alt.med claim. That’s often a pain as the writers can be coy about their references.

    An example, as an aside: ever heard of the R1H2 virus? Apparently it causes autism.

    What if I could say, “We know X and we know Y, which makes this new claim improbable –so improbable that it’s really impossible to study.” –might I avoid those terrible books?

    Hmm…

  9. Harriet Hall says:

    How about explaining that science-based thinkers don’t get their information from popular books, but from the peer-reviewed medical literature?

  10. Dr Benway says:

    Yes, that’s a handy tool in my box, HH. Last time I used it thus:

    “Dr. B* isn’t arguing his case for chelation and vitamins to me and other doctors like me. Instead he’s trying to convince Joe the Plumber. Why might that be?”

    I got a “Hmm. Good question…” from the mother.

    I also said, “When I ask for evidence, I want to hear the name of the Journal, the title of the article or the primary author, and the date. That’s what evidence means.”

    Mom promised me the references were in the book. And yes, in Dodgy Therapeutics for Autism, by Dr. B, there’s a bibliography on pages 417-432. Unfortunately there’s no easy way for me to zero in on the paper(s) in favor of, say nasal B12 for autism, which Dr. B recommends for this mother’s daughter.

    Mom wants me to call Dr. B. I’m not quite ready for the experience.

    Ever shared a patient with an “alternative” MD?
    ________________
    *name withheld, as the chap googles himself.

  11. marilynmann says:

    I think it is important to keep hammering on the concept of prior probability. John P. A. Ioannidis talked about this in “Why Most Published Research Findings Are False”

    http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020124&

  12. Nasal B12? Good grief. You’re being very, very good to this mom, Dr. Benway! I hope your patience pays off in dividends of her heeding your recommendations over Popular Book Doctor.

  13. Fifi says:

    Dr Benway – Perhaps it would be worth having a copy or two of books to loan out that debunk this kind of stuff and explain to patients how to think critically about medicine? Though, it may be more powerful to recommend the book and for the patients to buy it themselves (since people do give more credence to things that are more expensive than to free stuff – a human tendency that quacks often harness!).

  14. storkdok says:

    Dr. Benway, I’ve had lots of offers to “share” a patient with alternative MDs, who called me personally. I’ve always politely declined. Apparently they thought I, as a female OB, would be more “sympathetic” to them and their quackery. They never hit up my partners, who were all male.

  15. Joe says:

    I am fully in support of abolishing the NCCAM. However, it has extraordinary support in Congress (Sen. Tom Harken and Rep. Dan “The Loose Cannon” Burton). Given the focus on the major problems that everyone acknowledges, I doubt we can expect the new administration to go to battle over this.

    Manned space flight is arguably more in need of defunding. It certainly takes more resources away from science than does NCCAM; and when it fails it does so on a spectacular, human scale. Even if that is easier to achieve (Nixon simply canceled the last Apollo missions), I doubt one can get the attention of the administration for it.

    I would like to be proven wrong, on both counts.

  16. Prometheus says:


    “…as an aside: ever heard of the R1H2 virus? Apparently it causes autism.

    I’ve asked around the virology community – nobody has heard of it. Doing an extensive literature search – not just PubMed but also Web of Science and Biological and Agricultural Index – I was unable to find a single mention of “R1H2″.

    I went a bit further and found the original press report from the “Children’s Mental Focus Foundation”, dated 24 Jan 2008 (exactly one year ago today) and found this:


    “With our own funds we have developed a new method of therapy for children and adults. It is in the form of an energetic patch that will deliver information to the child’s body, which will help boost their own immune system to eventually control the virus and encourage the body to begin healing itself.”

    I’m glad I found this after I did the literature search.

    I wonder where “Rick C. Hunt, PhD” published his results? It’s been a year since he announced this momentous discovery – surely Medical Hypotheses would have published it?

    Prometheus

  17. marilynmann says:

    For health care providers who are looking for a book to recommend to their patients, I recommend Know Your Chances: Understanding Health Statistics, by Steven Woloshin, MD, Lisa M. Schwartz, MD, and H. Gilbert Welch, MD.

  18. “Hmmm. I was going to post on this topic again on Monday. Should I bother?”

    Please do. I’ve decided that this will be a more than one-part post. Above, I’ve added the planned content for one or more additional posts. It’s by no means comprehensive, so I strongly favor others continuing to write about it.

  19. pec says:

    “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”

    Why yes, let’s make up our minds before doing the research, instead of after. Very scientific.

  20. Dr Benway says:

    pec,

    It’s been said that applesauce causes autism. Should we research this?

  21. qetzal says:

    pec,

    Saying that the prior probability is closed to zero is based on the research.

  22. pec says:

    “Saying that the prior probability is closed to zero is based on the research.”

    No, prior probability is based on ideology, not research. If you deny that qi exists, then acupuncture cannot work.

  23. Harriet Hall says:

    Prior probability is based on the fact that research has found no evidence that qi exists. There is a big difference between ideology and absence of evidence.

  24. qetzal says:

    No, prior probability is based on ideology, not research.

    Maybe for you it is, but not when used properly.

    If you deny that qi exists, then acupuncture cannot work.

    That is also false. Acupuncture could work even if there is no such thing as qi. Just like drugs can work even if the claimed mechanism is wrong.

    However, the aggregated evidence suggests acupuncture does not work.

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