Apr 02 2010
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.
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.
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