Big news on chelation therapy, a claimed “detoxification” procedure. $30 million spent on an unethical trial that showed no real effect. But that isn’t going to stop the positive spin.
With a result that is likely to surprise and baffle much of the mainstream medical community, a large NIH-sponsored trial has turned up the first substantial evidence in support of chelation therapy for patients with coronary disease. Known as TACT (Trial to Assess Chelation Therapy), the highly controversial trial was presented today at the AHA by Gervasio Lamas. The trial was sponsored by two NIH institutes, the National Center for Complementary and Alternative Medicine and the National Heart Lung and Blood Institute.
Chelation therapy with EDTA to remove heavy metals from the blood in order to treat coronary disease has been around– and provoked criticism– since the 1950s. Despite a lack of evidence and the skepticism of the medical community, passionate supporters have kept the therapy alive in alternative medicine circles.
Now the results of TACT will likely provide ammunition to chelation defenders, but the trial investigators and other experts have expressed considerable caution about the proper interpretation of the results.
But LOOK at the headline!!! If there is considerable caution, why is the headline phrased as if it’s a positive?
Here is the more balanced look.
Chelation therapy didn’t change the ability to perform daily tasks or impact the emotional wellbeing of patients who previously suffered a heart attack, according to late-breaking clinical trial research presented at the American Heart Association’s Scientific Sessions 2012.
There was no impact on patient’s quality of life in this sub-study although the overall Trial to Assess Chelation Therapy (TACT) showed chelation therapy cut the risk of death, second heart attacks, stroke and the need for heart procedures among some patients who already suffered an earlier heart attack.
This quality-of-life study was a planned analysis of 911 randomly chosen patients from the overall trial of chelation therapy, an alternative treatment which uses weekly infusions to remove metals from the bloodstream.
“We didn’t see any effect on the quality of life of chelation therapy patients,” said Daniel B. Mark, M.D., M.P.H., lead author of the sub-study and professor of medicine, director of outcomes research at Duke University Medical Center and Duke Clinical Research Institute in Durham, N.C. “Patients weren’t any worse, but they weren’t any better.
Science based medicine blog announced the results yesterday.
It’s ironic, then, that the TACT results are informative in an important way that its authors seem to have overlooked: it convincingly demonstrates that the claims of chelationists have been bogus all along. That’s because those claims have been far more dramatic than even the small effect that the TACT may appear to support. Typically, chelationists, including those involved in the TACT, claim “improvement” or even “marked improvement” in 80-90% of patients with ischemic heart disease or other vascular disease.
Dr. Atwood says, “The TACT was an unethical trial for numerous reasons.” He notes to medical journals editors: “Publishing the Formal TACT Report would Violate your own Ethics” The TACT trial had a misleading consent form and participants were not correctly notified of important risks.
Orac calls chelation theory “pure quackery” and discusses the results of this study which ends what he calls a “long and depressing” story that cost $30 million.
Funny business is an understatement. A complete, unabashed fiasco would be a better description. Or maybe a total and complete waste of taxpayer money. Or perhaps an unethical sham of a trial, perhaps? Whatever you want to call TACT, this concern is quite consistent with worries expressed over six years ago by Dr. R. W. Donnell about the adequacy of the blinding of the trial. In light of such concerns, the differential drop-out rate between the two groups makes a lot more sense. Too bad that Dr. Lamias apparently didn’t see fit to include the relevant information in his press release or in his slide set.
Finally, no study would be complete without a consideration of adverse events. After all, in determining whether a therapy is worth pursuing, it is important to weigh its efficaciousness versus its safety. Overall, 79 adverse events were observed forcing discontinuation of infusions. Reasons included: reaching an endpoint; heart failure; other cardiac issues; GI problems; hematological problems; and a variety of other problems.
This treatment is HIGHLY implausible and did not have the expected positive results. How much MORE money do we waste on additional research through NCCAM on ridiculous ideas? This is sad. And it makes me angry. There have been many calls to kill NCCAM and this OUGHT to be another huge strike against it.