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Clinical Trials: Are They Safe? Look for the Stamp Feds Want a 'Seal of Approval' to Help Guarantee Patient Safety, Trust

By Jeff Levine

WebMD Washington Bureau Chief

Reviewed by Dr. Dominique S. Walton

April 17, 2001 (Washington) --The headlines on failed experiments are frightening, and members of a blue ribbon committee hope they can prevent more unnecessary deaths by applying a new recommendation from the Institute of Medicine (IOM). It calls for a 'seal of approval' -- or accreditation -- on human trials, as well as other basic reforms.

"[Accreditation] does, indeed, possess strong potential as a mechanism to strengthen the participant process protection system. We recommend that this approach be pursued as soon as possible -- in a thorough and deliberate manner," says Daniel Federman, MD, the IOM panel chair and distinguished professor of medicine and medical education at the Harvard Medical School. Consider just a few incidents from the last three years:

The Fred Hutchinson Cancer Research Center in Seattle, one of the top cancer research centers in the country, is accused of violating ethical standards in a study of experimental leukemia drugs where 20 patients died. The renowned hospital staunchly denies any wrongdoing.

Two years ago, the University of Oklahoma at Tulsa was hit by accusations that researchers there treated patients with a contaminated skin cancer vaccine. Following the incident, the institution overhauled its approach to medical research and replaced key staffers.

And in the most sensational case of a human experiment turned tragic, 18-year-old Jesse Gelsinger became the first patient to die as a result of gene therapy in 1999. His father Paul has become a crusader to reform the oversight system.

"They need to get philosophers and spiritual leaders and all segments of academia and the general public involved in determining the ethics of what they're doing. ... The money's the thing that's putting pressure on everything, and that's why these researchers lose their perspective," Gelsinger tells WebMD.

The IOM analysis took six months and is the first step in a review of clinical trial safety that will be concluded in 2002.

Ultimately, the accreditation would not be a specific set of guidelines but a "standard of standards" that focuses on performance, not just rules and regulations. Hopefully, that would inspire new confidence on the patient's part.

"I would think that that individual could safely ... conclude everything that's going to affect the patient is being looked at with a view to the highest standards. ... You want to look that person in the eye and say, 'This whole thing is being tuned up for your benefit,'" says Federman. Currently, two standards are being developed as accreditation measures. The committee suggests that the standard emerging from the National Committee for Quality Assurance seems most useful. This tool is ready for a field trial in VA hospitals around the country, although there is some concern that it's not quite ready.

Attorney Alan Milstein represented the Gelsinger family in their lawsuit against the University of Pennsylvania. He also is the attorney for patients in the class action suits in the leukemia and cancer vaccine cases. He tells WebMD that he's not impressed by the new IOM report, done at the request of the U.S. Department of Health and Human Services.

"We need a system of patient advocates where part of the money that goes into all these studies should be to allow independent patient advocates to counsel patients, so that patients understand what's in their best interest," Milstein tells WebMD. "No matter what the investigator tells the subject, the subject believes it's therapeutic."

However, the government official directly responsible for maintaining the integrity of the nation's human research trials lauded the IOM effort. He thinks a seal of approval can work.

"By having an accreditation process that is outside of government but can complement our regulatory and oversight activities, we'll actually be able to move toward a system of smaller, more effective government," Greg Koski, MD, PhD, director of the U.S. Office for Human Research Protections, tells WebMD.

Still, Koski said that not all research tragedies can be prevented. "The hope would be that when tragedies occur, they will be tragedies that don't result from people who have either violated the standards or neglected their responsibilities."

An accreditation standard, if adopted, would apply to both government-funded research and experiments in the private sector, which amounts to about two-thirds of all such studies.