Troubled study at heart of therapy debate
Disciplined doctors, potentially deadly drug marred study of questionable treatment that cost taxpayers $30 million
Dr. Rajiv Chandra, standing, with three of his patients that received chelation therapy. (Jacob Langston/Orlando Sentinel)
In 1978, the state Board of Medical Examiners in North Carolina disciplined Rozema's medical license after learning that in 1976 in Massachusetts, Rozema had pleaded guilty to and was convicted of the charge that he "did knowingly, willfully and feloniously extort by the use of force, violence and fear money," according to board records.
Medical boards in Illinois, South Carolina and Pennsylvania also disciplined his medical license, according to the North Carolina board. Rozema did not respond to requests for comment.
After Rozema and others spoke, Burton left officials with the NIH and other agencies in charge of medicine with an unambiguous message: "We are going to be hauling them before this committee on a regular basis — they will get sick of seeing my face before this is over — to make sure that we are not blocking something that is going to save lives."
In 2001, NCCAM and NHLBI issued a joint request for applications for a maximum $30 million federally funded grant to study chelation in people suffering from coronary artery disease. Lamas submitted an application that passed review by various NIH panels. TACT was a go.
More than 2,300 heart attack survivors older than 50 were sought, according to Lamas' 2003 protocol. Patients would be assigned randomly to one of four groups. Some would receive 40 infusions of the chelation solution recommended by the American College for Advancement in Medicine, plus either high or low doses of supplements. Others would receive 40 infusions of a placebo with either high or low doses of supplements. The study would be double-blinded, meaning neither volunteers nor researchers would know who got the treatment and who got the placebo.
"Welcome to the Trial To Assess Chelation Therapy!" Lamas wrote in a newsletter sent to study sites in 2003. "I am proud to welcome you to an elite group of physicians and coordinators who are committed to answering an important clinical question."
This group included many fine doctors who enrolled volunteers and ran study sites out of their own clinics.
But 13 of them have run afoul of state medical boards or health departments for actions unrelated to the chelation study, the Tribune found. Two physicians had their medical licenses revoked. Two others paid fines for placing misleading ads about the benefits of chelation therapy. One was issued two administrative complaints this year for allegedly running a clinic with unsanitary conditions linked to a hepatitis C outbreak.
Meanwhile, both consultants to the trial — each was paid more than $19,000 in taxpayer money, according to study records — were convicted of federal crimes, government records show.
One was Rozema, who also ran a study site and was among the first to enroll volunteers. The other was Dr. Martin Dayton. In 1986, a jury found Dayton guilty of mail fraud and conspiracy for his role in helping a family defraud an insurance company, according to U.S. Court of Appeals records. Dayton appealed, arguing, among other issues, that he had poor legal representation.
Today in a clinic in Sunny Isles Beach, Fla., Dayton offers several unproven remedies, including chelation and treatments with cell extracts made from pig fetuses and embryos, according to his website. His book "The Case for Intravenous EDTA Chelation Therapy" is available as a free download.
Dayton called his legal history "a distraction to your readership" and declined to discuss it further.
Lamas wrote in an email that only a small number of the physicians who participated in the study have troubled histories. "When these physicians joined the study, all had unrestricted licenses to practice medicine, granted by their state medical boards," he wrote.
One of the most critical parts of a trial is a process known as informed consent. The aim is to ensure that patients who agree to enter a clinical trial understand what they are getting into, including the potential benefits and risks.
But the consent form for TACT was misleading and omitted important information. For example, it failed to tell volunteers that edetate disodium was never meant to treat coronary artery disease and that one risk of the drug is death, according to a 2009 letter from the federal Office for Human Research Protections, which looks out for the welfare of subjects in federally funded studies.
The form also included the information that "EDTA," or edetate, had been approved as a treatment for lead poisoning, according to the letter.
That's true of edetate calcium disodium. But the drug used in the study, edetate disodium, is a different medication not used for lead poisoning.
The FDA issued a public health advisory in 2008 to warn that children and adults had died because the two drugs had been confused or because edetate disodium had been used to treat conditions for which it wasn't approved.