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My NCCAM Wish List

For a number of reasons, well-argued many times here on SBM, it would be beneficial to American citizens if the National Center for Complementary and Alternative Medicine (NCCAM) were abolished. This does not seem to be in the cards anytime soon. Here, then, are my suggestions for making the Center less dangerous and less of a marketing tool for pseudomedicine than it has been since its inception. Some suggestions might even make the Center somewhat useful. They are listed in order of priority. The Center should:

1. Abandon all unethical trials, beginning with the Trial to Assess Chelation Therapy (TACT, which is under the joint auspices of the NHLBI). This should be done in a very public manner. The reasons for abandoning the TACT, in summary, are as follows.

  • The TACT was conceived and approved not because of any scientific or medical promise, but because of pressure from a powerful demagogue in Congress, Rep. Dan Burton (R-IN). Burton was acting on behalf of a tiny, fringe group of physicians whom the editor of Chest and Archives of Internal Medicine had correctly called “pseudoscientific zealots” whose practices were “an abuse of the physician’s freedom of choice.” Barely 15 years later, TACT literature emanating from the NIH renamed the same practitioners “respected experts.” Their organization, the American Association for Advancement in Medicine (ACAM), actively lobbied for the TACT.
  • The TACT Principal Investigator (PI) made numerous false statements in his application for the grant and in his subsequent protocol submission, the effect of which was to give the erroneous impression that chelation is a promising treatment for coronary artery disease. I believe that those false statements constitute scientific misconduct. If the PI had offered an accurate review of the existing literature, any scientific review board or IRB worth its salt would have refused to approve the trial. In the event, the “Special Emphasis Panel” that the NCCAM convened to review the application included the very practitioner who, as President of the ACAM, had been instrumental in securing Rep. Burton’s influence. That practitioner was also named, in the application that he reviewed, as a member of a TACT committee, and would shortly thereafter become a TACT investigator. This is a violation of the NIH conflict of interest policy.
  • We have shown, and both the federal Office of Human Research Protections (OHRP) and the University of Miami IRB have acknowledged, that the TACT proceeded with a misleading consent form—so misleading that any change now, more than 6 years after the trial began, couldn’t possibly reverse the damage already done. Misleading statements in the consent form included a strong implication that the study drug was the relatively less dangerous calcium-sodium ETDA, not the very dangerous disodium EDTA used in the trial. The consent form also failed to state important risks, including death.
  • Almost 2 years ago the FDA withdrew its approval for disodium EDTA, which it had previously approved only for emergency treatments of digitalis toxicity and hypercalcemia. The FDA cited the dangers of the drug, including recent deaths associated with unapproved uses by ACAM members. Thus there is now no point in studying this drug because it is, for practical purposes, illegal.
  • We also showed, and the OHRP and U. Miami IRB also agreed, that many of the investigators in the TACT have criminal records, histories of discipline by state medical boards, histories of membership in IRBs disciplined by the FDA, and other indications of incompetent practices or worse. They are the pseudoscientific zealots mentioned above. I have argued on SBM that at least 2 deaths of human subjects in the TACT can be attributed to incompetent care at the hands of such investigators.
  • The TACT protocols, including far-too-biased investigators, inadequate blinding methods, multiple primary and secondary endpoints, and more (discussed here), are so tainted that whatever the reported outcome, it is unlikely that it will solve the very problem that it was intended to solve. The outcome will likely be equivocal, but even if it is reported as confirming or disconfirming, either conclusion will almost certainly be rejected by those who disagree.
  •  This suggestion—to abandon the TACT—isn’t really optional, although I am not so naïve as to think that NIH policy-makers will agree. It is not optional because the TACT violates numerous tenets of internationally recognized human studies ethics and numerous articles of the U.S. Federal Code of Regulations, and those violations are not retroactively remediable. As Henry Beecher wrote in his seminal article on human studies ethics, “an experiment is ethical or not at its inception; it does not become ethical post hoc…”

Thus to continue the trial, now that such violations are known, is not an ethically viable option for the NIH. Nor should the NIH succumb to political pressure framed as the “legislative mandate” of the NCCAM, which is its usual justification for such mischief. The reason is found in the Helsinki Declaration:

Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.

The NCCAM should also publicly address the horribly unethical trial of the Gonzalez regimen for cancer of the pancreas, even though that trial is over. It was spawned by much the same political pressure as was the TACT, it involved NIH-sponsored torture of hapless subjects, and its disconfirming outcome has done nothing to dissuade Gonzalez himself or his champions, including Burton and long time NCCAM advisee (and “Harkinite”) Ralph Moss.

Finally, the NCCAM must reconsider one of its recurrent public justifications for such trials: popularity. I have written about this several times (including in both the TACT article linked above and the Gonzalez regimen series here on SBM, also linked above) so I won’t go into detail here. In summary, “popularity”—which is almost always exaggerated, as it was in both of those cases—is a weak basis for a human trial: it should not trump a lack of scientific promise, and it never trumps welfare of individual subjects.

2. Stop using its public information function as an advertisement for fanciful, implausible claims. That it does this is apparent from even a passing glance at its website, but if examples are sought I refer you to a previous discussion.

3. Start using its public information function for some good, such as informing citizens that homeopathy is nonsense, or that those who claim a vaccine-autism link are both wrong and dangerous. It needs to confront the longstanding, close affiliation between “CAM” proponents and antivax hysteria.

4. Stop putting the cart before the horse by giving grants to medical schools to create “integrative medicine” centers, and stop promoting puff treatments of “CAM” for medical students.

5. Stop funding studies of “CAM” use and popularity, and begin trying to find out why it is that some people are drawn to implausible treatments, even in the face of compelling, contradictory evidence. Such investigations might begin by looking at the work of Beyerstein and Alcock, for example.

That’s it for now.

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

Leave a Comment (7) ↓

7 thoughts on “My NCCAM Wish List

  1. TimonT says:

    Excellent post! Thank you.

  2. windriven says:

    “because the TACT violates … numerous articles of the U.S. Federal Code of Regulations.”

    It would have been useful had those ‘numerous articles’ been enumerated. If a federal agency is violating CFRs it is possible that actual pressure can be brought to bear to terminate the trial. At a minimum it might stir journalistic interest and generate useful negative publicity.

  3. DevoutCatalyst says:

    I wish NCCAM would consider the welfare of those who in desperation turned to bogus CAM treatments and now feel ripped off and embarrassed.

    I wish NCCAM would consider the useful minds wasted learning things like acupuncture at much cost of time and money and dignity.

    I wish NCCAM would refine their website so it doesn’t look like it was written by some junior high schooler padding his resume applying for a paper route.

  4. daijiyobu says:

    A sixth wish, after I looked at NCCAM’s “Member Roster” through my Naturocrit eyes

    (see http://nccam.nih.gov/about/naccam/roster.htm ):

    remove the ND from the advisory board, for ethical reasons GALORE!

    E.g., the context of an ND degree is absurd:

    labeling that which is HUGELY science-ejected and -unsupported [the vitalistic, the supernatural -- figmentations and the like / the 'not-in-evidence'] for decades academically, clinically and commercially “science” [e.g., science-based, scientific, a branch of medical science].

    On that NCCAM page, you currently will see the 2007 ND appointee Birdsall:

    a 1985 Bastyr ND, naturopathic oncologist [WTF?] and ABNO board member, AANP board member, AANP’s 2009 ND of the Year, naturopathic oncologist and VP of Integrative Medicine at CTCA

    (see http://www.aanmc.org/careers/alumni-leaders-in-the-field/tim-birdsall.php )

    which also states:

    “[he] has been recognized by American Men and Women of Science [...and] Who’s Who in Science and Engineering.”

    Science, science, science.

    So, if you’ll indulge me a little more, here’s what:

    a) Bastyr’s mission is: conflate that which is scientific with that which is hugely not science and call the whole thing science (see the ad at http://colleges.usnews.rankingsandreviews.com/best-colleges/kenmore-wa/bastyr-university-22425 );

    b) CTCA says about naturopathy:

    b1) (see http://www.cancercenter.com/complementary-alternative-medicine/naturopathic-medicine.cfm ):

    “scientifically-grounded [...] backed by scientific research.”

    b2) yet, you have to go to another page (see http://www.cancercenter.com/bone-cancer/naturopathic-medicine.cfm ) to get at the science-ejected fundamental sectarian principle of naturopathy:

    “life force.”

    Birdsall’s ND wife, a 2000 NCNM grad., also works at CTCA.

    NCNM of course, has quite the irrational core ND premise page (see http://www.ncnm.edu/academic-programs/about-naturopathic-medicine.php ):

    “life force [...] the practice of promoting health through stimulation of the vital force [...] spirit [...] the physician must also make a commitment to her/his personal and spiritual development [...] these principles are based on the objective observation of the nature of health and disease and are examined continually in light of scientific analysis.”

    They need a Pigasus. And an external IRB, IMHO.

    -r.c.

  5. @windriven:

    Please check the links in the post (particularly here), which enumerate several violations of Federal Code. I just didn’t have time to repeat them here. Also, we have brought some pressure, as explained in the link to the OHRP determination letter. We have not yet heard anything from the FDA, and I don’t know if we will, but we’re still working on it. Regarding publicity, look here , here, here, and here.

    KA

  6. Versus says:

    I would like to add:

    Stop trying to turn “CAM practitioners” into scientists, to wit:
    “A relatively small number of CAM practitioners have been successful in obtaining NIH/NCCAM research training fellowships and career development awards compared to conventional researchers and allopathic [!] medical practitioners, such as those who hold Ph.D. and M.D. degrees.” This is because, according to NCCAM, they don’t have sufficient research training and/or experience. [Awww!] Nevertheless, no research skills? No problem! NCCAM will provide “up to $100,000 per year in direct cost for support of one CAM practitioner candidate. These funds may be used for salary and fringe benefits for the CAM practitioner, research supplies, travel, and/or tuition for courses if they enhance the research experience.” http://grants.nih.gov/grants/guide/notice-files/NOT-AT-07-005.html If CAM practitioners gave a “rodent’s posterior” [Gorski] about science and research, they wouldn’t be CAM practitioners. Or, if you put lipstick on a pig, it’s still a pig.

    Ditto CAM schools. http://nccam.nih.gov/research/extramural/awards/

  7. Jayhox says:

    Great post. It is worthwhile for readers of SBM to become familiar with the NCCAM website. Pay particular note at the “Research Results” on the right side of the page. Take a few moments to actually investigate the results of their research. As has been amply and oft stated, nothing new or promising has come out of NCCAM in the decade or so (and despite billions of dollars of taxpayer funding) it has existed. Nobel worthy research such as “Cranberry juice does not interact with antibiotics in the treatment of UTI” is spun as an endorsement for cranberry juice. The other results have the basic formula “X may help some people with sore backs” or “Y may be beneficial to those with aching knees” or some such breakthrough. Couched in their negative results are spins, obfuscation, and hand waving in an attempt to protect their turf and justify their existence.

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