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Elizabeth Cooney is a health reporter for the Worcester Telegram & Gazette.
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Wednesday, June 27, 2007

Keeping promises to research subjects

By Elizabeth Cooney, Globe Correspondent

Academic researchers keep their distance from pharmaceutical companies providing drugs for clinical trials, but sometimes that arms-length remove can lead to problems, Harvard authors say.

In an article in tomorrow's New England Journal of Medicine the Harvard scientists explore a case in which research subjects sued the drug company Amgen when a Parkinson's therapy being tested by the University of Kentucky Medical Center was no longer available to them. The study was stopped early because of concerns that the drug was neither safe nor effective, but some subjects said it helped them and wanted to keep taking it.

Participants had signed informed-consent agreements that said they could continue getting the drug after the trial ended, but the court ruled last year in Abney v. Amgen that the form each subject signed was a contract between the subject and the researchers, not Amgen. That meant Amgen had no obligation to provide the drug.

"I think this is one of those issues that kind of lurk below the water line but probably is quite prevalent," Michelle M. Mello of the Harvard School of Public Health said in an interview. "Consent forms promising access to study drugs are fairly routine. We want subjects to feel that whatever promises that are made to them are going to be carried out unless there’s a very good reason not to."

Mello and co-author Dr. Steven Joffe of Harvard Medical School suggest that research centers could solve the problem by ensuring that promises made to trial subjects are legally binding on the sponsor or met by the research center and that any limits to promises are clearly spelled out.

"Much of the problem highlighted by Abney can be avoided through more careful drafting of contracts," the authors write. "Notwithstanding the advantage of an arms-length relationship between academic investigators and industry sponsors, such an arrangement has undesirable legal consequences."

Posted by Elizabeth Cooney at 05:00 PM
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