Jun 23 2009
In May 2008, the article “Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned” was published online in the Medscape Journal of Medicine. The authors included two of our own SBM bloggers, Kimball Atwood and Wallace Sampson, along with Elizabeth Woeckner and Robert Baratz. It showed that the existing evidence on treating heart disease with IV chelation did not justify further study, and that the TACT trial was questionable on several ethical points. Their ethical concerns were taken seriously enough that enrollment in the trial was put on hold pending an investigation. It has now been re-opened after a few band-aids were applied to the ethical concerns. The scientific concerns were never addressed.
I have seen many critiques of the Atwood study, and not a single one has offered any cogent criticism of its factual content or reasoning. Most of them could have been written by someone who had not bothered to read beyond the title. Their arguments can be boiled down to a few puerile points that can be further simplified to:
(1) I believe the testimonial evidence that chelation works.
(2) Atwood and his co-authors are bad guys.
Now Beth Clay has chimed in with an article entitled “Study of Chelation Therapy Should Not Be Abandoned.” I found it truly painful to read, but even the worst has some value as a bad example. Clay’s article could be used for a game of “Count the Errors.” I will point out some of them below.
The Content of Clay’s Critique
She has absolutely nothing to offer in rebuttal of the many scientific arguments in the paper, so she does what others do when they are “out of ammunition” or intellectually bankrupt. She resorts to ad hominem attacks and invents specious concerns. Her whole paper is beneath contempt. The sections of her article are:
• The authors are biased.
• They would not qualify as expert witnesses in court.
• She lists the credentials of the principal TACT investigator.
• She dismisses the study’s concerns about the other TACT investigators because she checked with licensing boards and “satisfied herself” that they were in good standing as of Sept 2008.
• The authors’ qualifications are inadequate.
• She offers a history of “the Quackbusters” and attacks Stephen Barrett.
• Under “Why Chelation Needs to be Studied” she mentions only a consent agreement, one opinion (Lenfant) mentioning one testimonial, and an irrelevant study showing that men with high lead levels had more heart attacks.
• She argues that the off-label use of drugs should be protected.
• She claims that other harm is done by “Quackbusters.” By attacking the use of chelation for cardiovascular disease they “probably” hinder its use for lead poisoning.
• Safeguards are built into the TACT protocol and harm to patients is unlikely. (Really? Two study-related deaths have already been reported: see http://www.sciencebasedmedicine.org/?p=132 )
• The ethical concerns raised by the article delayed TACT and resulted in a long, labor-intensive, and costly investigation at taxpayer expense. (The TACT study itself is far more costly).
As her “Conclusions” she states:
An important clinical trial has been hindered by publication of an agenda-driven 51-page article in MedScape, despite the lack of expert qualifications and known bias of the authors, and the fact that most authors derive income from legal compensation for testifying against medical professionals who use chelation or other alternative or complementary therapies in their practices. Investigation of off-label uses of FDA-approved drugs is essential for progress in medicine.
The assertions of self-appointed “quackbusters” should not be accepted at face value, even if published in a prestigious venue.
At the end of her article, she offers this disclosure:
My name is mentioned in passing in the article by Atwood et al. I have followed the chelation therapy controversy since 1994.
She does not disclose what the article revealed about her:
In May 2000, the NCCAM’s National Advisory Council for Complementary and Alternative Medicine approved the “concept” of funding a large trial of chelation, by a vote of 11 in favor, none opposed, and 2 abstentions. One of the speakers during the Public Comment session of that meeting was Beth Clay, a staff member of Rep. Burton’s House Committee on Government Reform.
She has done much more than “follow” the controversy; she has actively supported chelation research and was instrumental in getting TACT approved.
What She Failed to Address
She doesn’t acknowledge one of the important points of the Atwood study: the confusion between CaEDTA and Na2EDTA, the drug used in the TACT study. The TACT information says EDTA is approved for lead poisoning but that is only true for CaEDTA. Na2EDTA, the study drug, was never approved for lead poisoning. It was only approved for treatment of hypercalcemia and digitalis toxicity. It carried warnings that it was specifically contraindicated for arteriosclerosis. The FDA approvals for Na2EDTA have now been rescinded, meaning the study drug is now actually illegal in the US! Clay only perpetuates the confusion between calcium and sodium EDTA, making many of her comments nonsensical. Restrictions on Na2EDTA are irrelevant to the treatment of lead poisoning with CaEDTA. And it is not being prescribed “off-label” because there is no longer any labeled indication for using it.
Atwood et al. showed that all the published evidence in favor of chelation for heart disease consists of uncontrolled case series that are poorly documented and of questionable significance, while every controlled study of chelation has consistently shown negative results. They have shown how this is consistent with many other rejected treatments where initial testimonials were wildly enthusiastic and case series were promising but RCTs were negative. They gave the example of internal mammary ligation which was rejected based on weaker evidence than we have for chelation. It was promptly discontinued after 3 controlled studies involving only 47 patients showed that it was no better than sham surgery. Even chelationists now agree that the scientific studies have ruled out any robust effect of chelation for heart disease, and they have been reduced to looking for smaller effects that might not have shown in the previous studies.
The original rationale of chelationists was that removing the calcium from atherosclerotic plaque would help heart disease. When RCTs didn’t support that hypothesis, they shifted from that rationale to the idea that removing other heavy metals is helpful (an idea not supported by any evidence). Irrationally, they did not change their drug when they changed their hypothesis: they are still using the drug that removes calcium instead of the one that removes heavy metals.
She isn’t concerned by the concerns Atwood et al. raised about the TACT investigators’ ethics. It doesn’t bother her that some of them were convicted felons, were involved in fraud, or had lost medical licenses for harming patients. It doesn’t bother her that they are strong advocates of chelation and use it in their practice. It doesn’t matter that their own websites are promoting an experimental study drug in violation of federal rules. It is enough for her that her own survey shows they currently hold valid medical licenses.
She defends the qualifications of Lamas, the principal TACT investigator. The study did not question his qualifications. It did question his statements about chelation, but Clay doesn’t address those.
She calls TACT “well-designed” without answering Atwood et al.’s criticisms of its design, such as the unnecessary complication of providing two different levels of additional supplements and the multiple endpoints.
She doesn’t acknowledge that the TACT study will not settle the question. Its multiple endpoints make it likely that a spurious benefit will be found for at least one of them. Even if its results were resoundingly negative, it is highly unlikely that it would persuade chelationists to stop offering the procedure. The income of many of the investigators depends solely or largely on providing this treatment, and they believe in it with the kind of zeal that is often unresponsive to evidence.
The Authors’ Qualifications
The expert witness standards she cites apply to conventional medicine. The courts do not require an expert witness to be a quack in order to testify against quackery. Anyway, this is a scientific paper, not a court case.
Clay points out correctly that the authors are not board-certified cardiologists, do not provide chelation therapy, and have slim research credentials. That doesn’t mean they aren’t eminently qualified to comment on the TACT study. You don’t have to be a smoker or treat lung cancer to be able to evaluate the published literature and see that smoking causes lung cancer. You don’t have to be a cardiac surgeon to reach a conclusion about internal mammary ligation based on studies showing it is no better than sham surgery. You don’t have to be a poor scientist to recognize poor science. You don’t have to be a logician to recognize errors in logic.
If the authors HAD all been board-certified cardiologists, or had experience with chelation for approved indications like lead toxicity, or had better research credentials, would that have changed their findings or influenced their conclusions? That seems unlikely, since chelation for atherosclerosis has been condemned by the Medical Letter, the American Heart Association (AHA), the American College of Physicians, the American Academy of Family Physicians, the American Society for Clinical Pharmacology and Therapeutics, the American College of Cardiology, the American Medical Association, and the American Osteopathic Association.
The authors have a special expertise that Clay doesn’t understand and that is not recognized by a formal board or organization. They are experts in recognizing poor science, pseudoscience, and health fraud. They have a deep understanding of the psychological factors that can lead even the best scientists to fool themselves. They have a combined wealth of experience and wisdom that would be hard to duplicate elsewhere. By long practice they have become skilled in detecting logical flaws and poor methodology in published studies. They have special expertise in evaluating the strength of evidence behind scientific claims. Their only “bias” is a bias in favor of science and reason.
The fact that they are not government officials or applicants for research grants leaves them free to criticize government officials involved in unethical research. Washington insiders and critics of government bureaucracy should appreciate that their ability to look at this research from the outside is a strong advantage.
Clay’s comments about what she calls “Quackbusters” and about organizations like the NCAHF are irrelevant and gratuitous. What on earth does Stephen Barrett’s performance on a psychiatry board exam have to do with the subject under discussion? (I’m not going to believe what you write because someone who often agrees with you once failed a test?)
She mentions the Scientific Review of Alternative Medicine as “the journal of which he [Sampson] purports to be editor in chief” and says it “claims to be a peer-reviewed journal” and she “wonders whether it is now defunct.” I recently received a new issue of that journal and Sampson is still listed, as he has been in every issue, as editor in chief. I can vouch for the fact that it is peer reviewed, as I have personally been both reviewer and reviewee.
She tries so hard to find criticisms of Atwood that she even attacks the reputation of a large conglomerate that includes the hospital he is associated with on the grounds that 3 doctors who worked elsewhere in the conglomerate failed to report income from drug companies. She attacks Baratz because his clinic uses Botox and 16 Botox-associated deaths have been reported to the FDA. She uses that example to claim that EDTA is proved safe because more people have died from proper use of FDA approved drugs!
She accuses the authors of misrepresenting their qualifications, but she has not shown that they did so. She questions their university affiliations because she “found no evidence that any of these authors actually teach or have ever taught academic courses.” The academic titles they list do not imply that claim; they indicate involvement in teaching in clinical settings. Not that it matters, but at least one of them HAS taught formal classroom courses.
Her criticisms amount to nit-picking, innuendo, and irrelevant facts that do not impact on the authors’ qualifications to write this paper.
If she had anything intelligent to say about the content of the paper, she would have no need to resort to this kind of mean-spirited character assassination. Despite all her ad hominem venom, she fails to show that anything the authors wrote is inaccurate.
Ms. Clay’s Qualifications
She doesn’t think the authors are qualified to critique TACT, but she herself has no scientific qualifications. She accuses them of bias, but her own bias is obvious.
During her Capitol Hill tenure, Ms. Clay’s work focused on several breakthrough issues, including: complementary and alternative medicine, dietary supplement regulation, the epidemic rise in rates of autism spectrum disorders…..issues…..mercury and heavy metal toxicity.
She is also a Scientologist, accepting beliefs written by a science fiction writer who had declared his intention to invent a religion. I wonder if she really believes Xenu brought billions of his people to Earth in DC-8-like spacecraft, stacked them around volcanoes and killed them using hydrogen bombs, and that the essences of these many people remained, and that they form around people in modern times, causing them spiritual harm.
But you can forget I even mentioned her qualifications. Ad hominem considerations are really irrelevant. What matters is what she wrote, not who wrote it. And what she wrote is WRONG from beginning to end.
Count the Errors
I’ve already mentioned some of the errors, but here are a few more:
“They claim that 30 deaths (etc.)” No, they presented evidence of least 30 deaths compared to the zero deaths claimed by the chelationist organization and tacitly accepted by the lead investigator of the TACT study.
“Most authors derive income from legal compensation for testifying…” Atwood, the principal author, has not. Neither has Sampson. Baratz and Woeckner have been paid for time only in court cases, as stipulated in their disclosures.
“Sampson, Atwood, and Baratz are members of a web of organizations and activities whose sole purpose is to stand against the use of chelation therapy and alternative medicine.” The only organization she mentions is the NCAHF, of which Atwood is not a member. The term “Quackbusters” is purely an invention of alternative medicine advocates, artificially lumping together all who question their claims. There is no “web” in any formal sense; there are only a lot of likeminded individuals who independently apply the same standards and therefore naturally reach the same conclusions about alternative medicine. The purpose of NCAHF and of the authors is not “to stand against chelation” but to apply science and reason to health claims and to reject those that are not supported by evidence.
“A tiny and shrill minority of physicians appears to stand against scientific inquiry.” No, a few clear-thinking physicians have spoken out against one specific study that violates the principles of scientific inquiry and that owes its existence to politics rather than to scientific judgment.
“An internet search revealed a relationship between the Medscape Journal of Medicine and the NCAHF.” No, it only revealed that Stephen Barrett (who has nothing whatsoever to do with TACT or with the Atwood article) is a member of NCAHF and also a board member and occasional peer reviewer for Medscape. She represents this as “close ties” and thinks it is sufficient to raise questions about the veracity of the peer-review process and the true intentions of the journal! Then she unreasonably faults Atwood for not disclosing this information. Why on earth should he?
“Investigation of off-label uses of FDA-approved drugs is essential for progress in medicine.” Use of sodium EDTA isn’t off label because there is no longer a label to be off. Even when the label existed, it wasn’t being used off-label but anti-label, in direct disregard of a warning not to use it for this indication.
There is more, but I’ll stop here.
Clay’s article is a totally unreasonable, unconvincing attack on the Atwood article, filled with irrelevancies, misdirection, and ad hominems, devoid of any cogent discussion (or even acknowledgement) of the points made by Atwood et al. It doesn’t even distinguish between CaEDTA and Na2EDTA. I found the extensive personal attacks frankly offensive. This ideologically motivated hatchet job commits all the sins it would like to think the Atwood article commits, plus many more. It is a further disgrace to the already disgraced journal that published it.
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