Medical trial oversight in poor shape

September 18, 2005|By Julie Bell | Julie Bell,SUN STAFF

DESPITE widespread recognition of the need to do a better job protecting millions of Americans enrolled in medical experiments, the government has made few changes in the system that oversees their care.

Now, it appears some of the first changes to be recommended by a government advisory panel will involve loosening the rules, not tightening them.

To be sure, many academic research institutions and private research companies have made their own changes, some extensive. The moves came after the deaths of research subjects such as Johns Hopkins University's Ellen Roche in 2001.

But even many charged with overseeing clinical trials agree that, years after the deaths sparked a national outcry, the system of oversight contains holes and major flaws.

Some research on people continues to go totally unregulated, including many studies initiated by physicians to look at how diseases work. And when the government does require oversight - in cases where the research is federally funded or involves a drug or medical device in the running for Food and Drug Administration approval - it relies on ethics panels that studies have shown are often overworked.

While highly publicized deaths caused by clinical trials have been few, some argue that the scope of the problem is far greater than meets the eye.

Adil Shamoo, editor of Accountability in Research and co-founder of the advocacy group Citizens for Responsible Care and Research, found in a 2001 study that just eight deaths had been reported to the federal Office of Human Research Protection from 1990 to 2000 for research involving 70 million people.

Shamoo continues to argue that the number of deaths is underreported, saying the anticipated number of suicides and suicide attempts alone in a population that large could be anticipated to be 5,000, while the overall deaths in a general population of 70 million would be about 51,000.

"My guess is it's going to take another tragedy" to galvanize support for more oversight and training money, said Dr. Greg Koski, who previously headed the federal Office of Human Research Protections.

System failed

Paul Gelsinger is among those who thought it wasn't supposed to turn out this way.

Gelsinger, 53, has been seeking reforms since his son Jesse died in a gene-therapy experiment at the University of Pennsylvania in September 1999. Six years later, the father gives the impression of a weary salesman as he continues to seek reform in the system that failed his son.

Last month, the retired Tucson, Ariz., handyman dropped his two travel bags at the rear of a drab meeting room in Alexandria, Va., greeted familiar members of a government advisory committee and launched into a story they already knew. Jesse, he said, died at 18 of an immune-system reaction because doctors enrolled him in the experiment without fully explaining the risks.

"My real feeling is that I should be done with this by now," Gelsinger said after the meeting. But "I'm finding this process is just beginning."

Now, as the Advisory Committee on Human Research Protections readies recommendations, critics such as Gelsinger are disappointed again. They say most proposals they have seen would make life easier for the ethics panels that oversee research, instead of beefing up protection for volunteers.

The committee is discussing the following changes for ethics panels:

Telling the panels they don't have to thoroughly review previous published studies before approving a new experiment. The practice began voluntarily after the government faulted a Hopkins panel for failing to discover the known dangers of a chemical that Roche inhaled in the lung function experiment that led to her death.

The literature reviews should be the responsibility of physicians overseeing the research trials, committee members said.

Elimination of yearly reviews for every research project, as is now required. Some studies, panel members reason, aren't risky enough to warrant such attention.

More reviews with only one or two panel members, instead of the whole group. Ethics panels can already do this when the study poses little risk to volunteers (involving, for example, only the drawing of blood) or when minor changes are made in approved research.

Separately, the government is considering how to reduce the number of problem reports that ethics panels receive from clinical trial sites around the world.

The current oversight system dates to the 1970s, when panels largely oversaw trials held only at their local institution. But many trials now take place at dozens of sites or more, and the volume of injury reports can overwhelm local panels, which often don't have enough information to interpret them, said Ernest D. Prentice, a University of Nebraska associate vice chancellor and the advisory committee's chairman.

The proposed changes are preliminary, and it's too early to tell what the government will do. But proponents say regulatory relief will be a good thing for both volunteers and science.

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