Saturday, September 27, 2008

Update on the NIH “Trial to Assess Chelation Therapy”

(Some of the following is identical to a post on Science-Based Medicine dated 9/26/08.)

A few days ago, while gathering information for a post on Science-Based Medicine about intravenous hydrogen peroxide, I noticed this:



ACAM Supports NIH Decision to Suspend TACT Trial

September 3, 2008, Laguna Hills, Calif. — The American College for Advancement in Medicine, ACAM today announced its support for the National Institute for Health’s (NIH) decision to suspend patient accrual of the Trial to Assess Chelation Therapy (TACT) Trial until allegations of impropriety can be proven false. ACAM believes that the TACT trial represents a important milestone in assessing the role of chelation therapy in modern healthcare and respects the decision of the NIH.

ACAM continue to work with Dr Tony Lamas to answer the unfounded allegations of impropriety.

“We believe that the Office of Human Research Protection (OHRP) will find that the allegations are of a political nature. To serve the best interests of participants enrolled in the TACT trial and all patients and their physicians who seek answers about chelation therapy, we call for a swift end to the moratorium and resumption of the trial,” said Jeanne Drisko, MD, President of ACAM.


I alerted a few others, including Stephen Barrett of Quackwatch, who queried the news room of the National Heart, Lung and Blood Institute (NHLBI: the joint sponsor, along with the NCCAM, of the trial) and got this reply:




The investigators and institutions performing the Trial to Assess Chelation Therapy (TACT), in conjunction with their Institutional Review Boards, have temporarily and voluntarily suspended enrollment of new participants in the study. NIH has not issued any announcement or press release about this action. To contact the Office for Human Research Protections’ (OHRP) press office, call Pat El-Hinnawy, (202) 253-0458.

The “allegations of impropriety” mentioned in the ACAM press release had been made by my co-authors and me in a comprehensive article previously introduced on Health Care Renewal here. The article is available in its entirety here. In June, we made a formal complaint to the federal Office of Human Research Protections (OHRP), citing that article and additional information posted on Science-Based Medicine here. That our complaint was the instigating factor for the recent “decision to suspend patient accrual” is suggested by an email that I received last week:



I would like to know who is paying you guys off. Finally we have a chance to assess Chelation therapy and put the issue to rest and to find out whether or not it really works and you bozos screw it all up. I know that the trial was stopped and it is your fault. What are you afraid of? Why are you not decrying all of the injuries caused by medications and unnecessary surgeries? Why are we the citizens of the US deprived of a trial of EDTA so that we can judge for ourselves?

Anyone who is a thinking man, can only be disappointed in you. [sic]

Binyamin Rothstein, D.O.




Rothstein, unlike many of his fellow ACAM members, does not appear to be a TACT investigator. Like them, however, he touts chelation, intravenous hydrogen peroxide, and other baseless and dangerous treatments. He has harmed patients, his protestations nothwithstanding. His medical license was revoked in 2005, but that hasn’t hindered him from using smoke and mirrors in his relentless pursuit of profit from nonsense. He’s even managed to promote himself to the public without revealing key items from his resumé—one of the many reasons that even the most diligent regulation can’t always protect the public from scoundrels.

At least two reporters have recently covered the story (here and here). They mostly get it right. The AP report, however, states that chelation "is mainly used to treat lead poisoning." That is not technically false, but is misleading because disodium EDTA (Na2EDTA), the drug used in the TACT, has never been approved for lead poisoning and is considerably more dangerous than calcium EDTA, the drug that is so approved. Ironically, one of our objections to the TACT is that its literature---including protocols, consent forms, and subject recruitment pitches---conflates the two drugs so as to make the study drug appear safer than it is.

Indeed, the FDA has recently withdrawn its approval of Na2EDTA, citing "important safety information" and the possibility that it may be confused with the less dangerous CaEDTA:



As noted in the January 16, 2008, Public Health Advisory, there have been cases where children and adults have died when they were mistakenly given edetate disodium instead of edetate calcium disodium (calcium disodium versenate) or when edetate disodium was used for indications other than those approved by FDA.



Readers might remember that we at HCR have previously discussed the important distinction between the two EDTA salts, after a 5-year old boy was killed in Pennsylvania when a quack administered Na2EDTA to him as a treatment for autism. At the time a CDC expert was so surprised that anyone would infuse Na2EDTA that she concluded, erroneously, that it must have been a drug error: "a case of look-alike/sound-alike medications." The PA medical board's investigation subsequently confirmed that the practitioner had intended to give Na2EDTA, exactly as we had predicted.

The TACT should now be stopped altogether. Contrary to the ACAM press release, our objections to the TACT are scrupulously documented and not “of a political nature.” They are of a scientific and ethical nature. They will not be proven false, because the evidence for them is overwhelming.

8 comments:

Anonymous said...

This was also covered on the Sept. 26th WSJ Health Blog with this quote: "Supporters of chelation suggest that the treatment can help treat heart disease by removing plaque from artery walls. But the AHA says there’s “no scientific evidence to demonstrate any benefit” from chelation for heart disease."

Steve Lucas

Anonymous said...

This was also covered on the Sept. 26th WSJ Health Blog with this quote: "Supporters of chelation suggest that the treatment can help treat heart disease by removing plaque from artery walls. But the AHA says there’s “no scientific evidence to demonstrate any benefit” from chelation for heart disease."

Steve Lucas

Anonymous said...

I would like to know who is paying you guys off.

It seems 'researchers' like this can hardly conceive of those who act on morals and conviction, because such 'researchers' probably lack them - other than the love of money.

Hence the accusation of payoffs, since that's the only motivator such 'researchers' themselves know.

MedInformaticsMD said...

Kimball,

I note with amusement and disappointment the many pathetic, irrational, street-agitator-style attempts at dismissal or diminution of your article in the comments section of the Medscape Journal (link).

Unfortunately for the people who post such comments, at this blog and other healthcdare blogs they will not be dealing with neophytes to countering both irrational argument and 'political warfare' definitively and effectively.

They also cannot stop the diffusion of this knowledge to places of importance.

They no longer control the narrative.

MedInformaticsMD said...

By the way, regarding "ACAM continue to work with [PI] Dr Tony Lamas to answer the unfounded
allegations of impropriety
":

... Dr. Gervasio Lamas, director of Cardiovascular Research and Academic Affairs at Mount Sinai
I Medical Center in Miami, is apparently the PI. Per the link, "Dr. Lamas is also spearheading a clinical trial at
Mount Sinai to test chelation therapy, an alternative medical treatment for coronary artery disease."

Regarding Mt. Sinai Medical Center, I'd written on my experience there at this link:

Organizational Learning Disability? Miami Beach Hospital gets an "F" on Informatics.

In retrospect, I can perhaps better understand why they found a Medical Informaticist of my background "not the right fit" for Director of Medical Informatics.

While I did not meet their CV Research Director, I did meet their Chair of Internal Medicine and touted my ethics and my ability to build advanced information systems in cardiology and other specialty domains (as I did at Christiana Care) that could be used to great advantage in assuring excellent science.

Theoretically speaking, of course, I can imagine they could have had concerns with the issues my ability and desire could (potentially) create for an organization whose Director of CV Research & Academic Affairs was running controversial 'chelation trials', and for the IRB that reviewed same.

My blogging might have also been a deciding factor.

I was not the "right fit" indeed for Director of Medical Informatics there, and now humbly agree with that assessment.

In the spirit of Medical Informatics, which deals in elimination of ambiguity in terminology among other issues, I also invite the ACAM to clarify (with references) what they mean by “We believe that the Office of Human Research Protection (OHRP) will find that the allegations are of a political nature."

To my untrained eye, the only "politics" I see in the "allegations" are a well-documented, sound critique of what appears to be cavalier pseudoscience, biomedical incompetence and quackery.

I remind ACAM that their answers will be fact-checked with all of the worldwide biomedical information resources at the disposal of information science experts with access to excellent university libraries.

Roy M. Poses MD said...

It does often seem that organizations that first come to our attention because of one problem often have a whole host of problems, some of which may later be revealed. The explanation may be: when a problem is severe enough to get into the media and be noticed by us, there usually are layers of bad leadership, bad
governance, and toxic corporate culture underlying it.

james wilkins said...

“chelation therapy is an office treatment which on average for 20 to 40 infusions runs an estimated cost between $2000-$4000 dollars. Thus, both the benefit-risk profile and the cost- effectiveness of chelation are likely superior [!!!] over bypass and angioplasty.”the National Institute for Health’s (NIH) decision to suspend patient accrual of the Trial to Assess Chelation Therapy (TACT) Trial until allegations of impropriety can be proven false. ACAM believes that the TACT trial represents a important milestone in assessing the role of chelation therapy in modern healthcare and respects the decision of the NIH.
-----------------
james wilkins

Link Building

MedInformaticsMD said...

ACAM believes that the TACT trial represents a important milestone in assessing the role of chelation therapy in modern healthcare and respects the decision of the NIH.

How accomodating of ACAM.

What, exactly, might they have done? Ignore the NIH?