Requiring a drug studies registry

Thursday, September 30, 2004

WASHINGTON

Scientists are conducting thousands of medical experiments that can offer tantalizing hope to the ill, but tracking them down and getting enrolled can be incredibly difficult.

It might get easier, thanks to a growing push by doctors and lawmakers to force drug companies to list on a national registry every study they conduct.

Currently, learning what experimental treatments are being tested for diseases ranging from arthritis to cancer to Parkinson's is a hit-or-miss proposition. It's one reason so few patients participate; even for cancer, where clinical trials are touted most, just 3 percent to 5 percent of patients are estimated to enroll.

There is no comprehensive list of what's available. A government-run database called www.clinicaltrials.gov is supposed to list most studies of treatments for serious diseases. But federal law set no penalties for violations, and less than one-fifth of the 4,200 ongoing studies listed are sponsored by drug companies -- even though industry funds most of the nation's treatment research.

Several hundred other registries or Web sites promise study listings, but not all are open to the public or have up-to-date, reliable information, notes Dr. Ron Davis of the American Medical Association.

Plus, many local doctors don't participate in research and thus don't think to tell their patients it's an option, says Dr. Ted Gansler of the American Cancer Society, which is pilot-testing a service to help match patients to the studies best suited to their specific cancer.

"I'm trying to probe some secret cave of knowledge," is how patient Connie Ojile of Arlington, Va., describes today's system.

Desperately seeking an experimental treatment for her intractable leukemia, Ojile was in tears last week after spending hours on the phone and computer fruitlessly tracking a doctor's tip about a promising study. She couldn't even discover if the study would begin soon enough for her to participate.

"You know the drug's out there," she said in frustration. "I'm getting sicker every day."

Researchers are frustrated, too. The lack of patient information makes it difficult to recruit enough study participants, thus slowing discoveries of how to improve treatments, says Dr. Gary Cohen of the Greater Baltimore Medical Center, who is working with the Sidney Kimmel Foundation for Cancer Research to change that.

The AMA proposed a mandatory study registry because of a different problem: the recent discovery that some drug companies hid data linking antidepressants to suicidal behavior in children. A registry would allow tracking to ensure results of every study started eventually are released.

But easier patient access is an important side benefit, says Davis of the AMA.

Members of Congress are writing legislation backing the AMA proposal, although it's unclear how quickly lawmakers will move. But starting next summer, the nation's most prestigious medical journals won't publish results of any study not initially listed on a public registry such as www.clinicaltrials.gov -- adding pressure to researchers to increase access now.

Pharmaceutical Research and Manufacturers of America, an industry group, encourages drug companies to cooperate with that database, but opposes making a registry mandatory.

But a registry won't solve all the barriers. Among them:

While drugs tested in clinical trials are free, patients still need regular care for their disease. Yet some insurers balk at paying even routine bills for study participants. Also, early-stage studies or those for rare diseases often are conducted at only a few hospitals, requiring significant travel costs.

Ojile, the leukemia patient, borrowed money to fly to Houston's M.D. Anderson Cancer Center to see if she qualified for a cutting-edge drug experiment. She did, but was told her insurance might not pay all the out-of-state bills, and she couldn't afford the monthslong hotel stay required to be near researchers. She's now hunting for a study closer to home.

Local doctors often don't suggest clinical trials until patients fail numerous other treatments and have advanced disease.

"The chances of curing patients at that stage are a lot lower," warned M.D. Anderson leukemia specialist Dr. Jean-Pierre Issa, who says numerous studies in fact need early-stage patients. To improve recruitment, his department sends a newsletter to 20,000 community oncologists listing its new leukemia studies.

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