The largest alternative medicine study trial suspends enrollment while it undergoes investigation by the government. The feds claim that the study isn't looking at participant safety, which is just one of many errors being taken seriously by officials.
The use of
chelation therapy is no stranger to controversy and had recently been dropped as a potential beneficial study in children with Autism, showing no benefits. However, an ongoing study in the alternative medicine community using the same metal-flushing therapy that dates back to the World Word I era is now under investigation.
According to an
AP news article:
Federal officials confirmed their probe of the $30 million study on Thursday. Those directing the research, conducted at 100 sites around the United States and Canada, voluntarily stopped enrolling patients earlier this month, after the investigation was launched.
The study, which opened in 2002, was supposed to serve as an alternative therapy option to patients who suffer from heart attacks and heart disease as opposed to tradition heart medications, surgery and angioplasty. The claims now say that it was based on false representations, including possible full informed consent of those enrolling in the study as well as financial kickbacks for using the therapy.
A group of chelation supporters and practitioners made the following statement in response to the suspension of the trial:
"to answer the unfounded allegations of impropriety" and said federal officials "will find that the allegations are of a political nature."
"We call for a swift end to the moratorium and resumption of the trial," says the statement by the group's president, Dr. Jeanne Drisko.
The study's lead physician dismissed claims of potential study related deaths and said in the article that "any study involving older heart attack survivors was bound to have deaths." Given the nature of the enrolling trial patients age 50 or older and having a history of heart attacks, it will be interesting to see if the investigation finds that any of the deaths are considered study related.
Some of the physicians participating in the study have also had to drop out due to disciplinary actions or criminal records.
The leaders in the drug and medical field, including the FDA and AMA, have called chelation experimental and stated that its value to heart patients isn't known. Still others who side with the beliefs of these groups in conventional medicine also believe that the therapy is worth studying.
It is the largest alternative therapy trial to have ever been approved.
To see that the study has not been completely suspended and that those currently enrolled are being allowed to continue therapy while investigators look into the claims says a lot about the level of danger associated with the actual trial. The outcome of this investigation may have great implications for the future of alternative therapies and trials associated.
chelationwatch.org
Study Information
American Heart Association
