More than a dozen physicians involved with the Trial to Assess Chelation Therapy have run into trouble with federal regulators, state medical boards and even, in some cases, the law:
•Dr. L. Terry Chappell, testified at Rep. Dan Burton's 1999 congressional hearing on chelation; served on the National Center for Complementary and Alternative Medicine's Special Emphasis Panel, which reviewed the application for the TACT grant.
Chappell was secretary of the Great Lakes College of Clinical Medicine institutional review board when it received a warning letter from the U.S. Food and Drug Administration in 2000 and voluntarily shut down the following year.
Institutional review boards are independent panels that aim to ensure clinical trials are conducted ethically, scientifically and safely, but the FDA letter cited numerous problems with the way this one was run, including that board members voted on their own studies and many of those studies were flawed.
For example, the board approved a study in which volunteers with HIV in China were to be injected with blood from a person infected with malaria — an unproven and potentially deadly treatment with little scientific justification, according to the warning letter.
In response to questions, Chappell wrote in an email that "informed consent and patient safety were our top priorities." The board chose to shut down because "we did not have the financial resources to meet all the new regulations," he said.
•Dr. Carol Roberts, TACT site investigator.
This year, the Florida department of health filed two administrative complaints against Roberts, whose tips to keep volunteers in the study were quoted in the TACT newsletter.
The department detailed unsanitary conditions at Wellness Works, where Roberts was medical director. The patient treatment room did not have a sink, according to the complaints, and patients' blood "spread from towels, worktable top and clothing of patients."
The complaint also alleged that a nurse had reused single-use vials of medicine in administering intravenous chelation and other treatments.
A preliminary report by the health department identified 11 cases of hepatitis C among patients in Roberts' practice.
Efforts to reach Roberts for comment were unsuccessful. According to TACT principal investigator Gervasio Lamas, "the break in sterility within her practice did not affect any TACT patients."
•Dr. Jack Slingluff, TACT site investigator.
An Ohio osteopath, Slingluff was accused of knowingly causing the delivery of 30 vials of the unproven cancer treatment Laetrile, court documents show. He was sentenced to a year of probation after he pleaded guilty in 2004 to one misdemeanor count of introduction or delivery for introduction into interstate commerce of an unapproved new drug.
Slingluff later testified he had been treating cancer patients with Laetrile since the late 1970s, according to court records.
After his plea, the State Medical Board of Ohio suspended Slingluff's medical license for a year, according to board documents. The Ohio Supreme Court dismissed his appeal, and in 2008 the board permanently revoked Slingluff's license. Slingluff died this year.
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