IT鈥橲 a trial of a controversial alternative therapy for heart disease, and it involves some physicians with criminal records and others who have been disciplined by state medical boards. So why is the world鈥檚 leading biomedical research agency backing it?
That鈥檚 the question being asked by critics of a $30 million study funded by the US National Institutes of Health (NIH), who want the trial stopped.
The row involves , generally used to remove toxic heavy metals from the body. Some alternative practitioners claim that chelation can also dissolve the plaques that can form in arteries and increase the risk of heart attacks. In , the chelating drug ethylenediamine tetraacetate (EDTA) is being tested for its ability to do this in people with heart disease.
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The treatment has already been tested in four trials, all of which gave negative results. But physicians who practice chelation for heart disease counter that those studies involved a total of just 300 people, which they argue is too few for a definitive answer. Since chelation continues to be prescribed by hundreds of US complementary medicine practitioners, the NIH agreed in 2002 to settle the matter by testing the treatment on almost 2000 volunteers over 50 who had previously had a heart attack.
The trial progressed without much further debate until May this year, when the records of some of the researchers involved came to light. One of the leading critics of the trial, Kimball Atwood, an anaesthesiologist at Tufts University School of Medicine in Boston, identified one doctor recruiting patients for the study who has a conviction for extortion, and a consultant to the study who had been convicted on two fraud charges. Of doctors at more than 150 sites who initially signed up to take part, Atwood found that one was recently indicted for supplying fabricated data to a different clinical study and 18 have been the subject of disciplinary actions by state medical boards (The Medscape Journal of Medicine, vol 10, p 115).
Gervasio Lamas, principal investigator for the study and a cardiologist at Mount Sinai Medical Center in Miami Beach, Florida, says that the indicted doctor and some of those with disciplinary records have since dropped out. He adds that the trial includes safeguards to protect volunteers鈥� welfare. EDTA can be dangerous if administered too rapidly, for example, so the trial鈥檚 electronic system is set up to flag any cases where the chelation session ends more than 15 minutes before the 3 hours recommended. The trial has been suspended in a handful of sites for minor breaches of this rule, but each has been restored following inspections by the independent safety monitors overseeing the study. This group meets every six months to review results from the trial and has found no reason why it should not continue, Lamas says.
Atwood also notes that almost two-thirds of doctors who initially signed up for the trial are at practices that earn money by offering chelation. The website of one states that every study of chelation for heart problems has 鈥渨ithout exception鈥� shown benefit. The language is very similar to that used in promotional literature that was declared to be 鈥渄eceptive鈥� by the US Federal Trade Commission in 1999.
鈥淥f doctors who initially signed up to take part, 18 have been the subject of disciplinary actions by state medical boards鈥�
Atwood last month sent copies of his paper to the Office for Human Research Protections, the federal body responsible for ensuring the welfare of research volunteers. The NIH insists, though, that its rules have been followed. One of these states that researchers with certain types of convictions within the past three years should not take part in studies; those highlighted by Atwood are older than that.
Still, some ethicists are concerned by the number of individuals with questionable records involved in the trial. 鈥淚f you start to see a pattern of red flags, it鈥檚 very troubling,鈥� says Jonathan Kimmelman of McGill University in Montreal, Canada.
The trial is volunteers. Kimmelman argues that patients enrolled into the study should at least be aware of the controversy surrounding the effectiveness of chelation therapy for heart disease. The debate might prompt them to seek a second opinion before signing up, he suggests.
