Friday, March 03, 2000
Web site explains experimental treatments
BY LAURAN NEERGAARD
The Associated Press
Your doctor grimly announces there's no more chemotherapy to try for your pancreatic cancer. Or you heard a news blurb about an experimental Parkinson's drug but your physician isn't testing it, so you're stumped. Or you'd desperately like a less toxic medicine for your child's rheumatoid arthritis.
Scientists are conducting thousands of clinical trials in a quest to improve treatment of those and hundreds of other diseases, yet less than 5 percent of American patients enroll in such medical experiments.
One reason: It's incredibly difficult for sick patients to ferret out who's studying what and then wade through the scientific jargon to determine if an experiment might help them or is too risky.
This week, the government opened a database to help.
Understanding risks
Congress ordered the comprehensive registry of all clinical trials for serious illnesses, with consumer-friendly explanations of how the experiments work and what questions patients should ask to ensure they understand the risks, such as:
• Why do researchers think this treatment will work better than standard care? How many people have tested it and what happened to them? What side effects are possible?
• What kinds of tests or procedures will I undergo? Will they hurt?
• Who is funding the study and who will oversee my care? Will I have to pay for any of it?
Each study lists a phone number to reach researchers about enrolling and ask those questions.
“This is a single place you can go where the most important information, we hope, will be available to everybody,” says Dr. Donald Lindberg of the National Library of Medicine, which opened the Internet-based registry — www.clinicaltrials.gov — Tuesday morning.
Get your own doctor to help sift the studies you find on the database, Food and Drug Administration Commissioner Jane Henney advises. Then if you enter a study, bring a friend or relative along to hear researchers explain the risks and benefits.
“If they don't understand something, it might be that you didn't either,” Ms. Henney warned. Patients “are very vulnerable for information that might sound too hopeful. . . . Be willing to ask questions and probe for information.”
The free database so far contains 4,000 studies at 47,000 sites nationwide, mostly government- or university-sponsored ones. But Congress mandated that it be comprehensive, so more studies, particularly drug-company trials, will likely be added in coming months.
A handful of other Internet sites also are attempting to list certain clinical trials; the communications company CenterWatch claims more than 200,000 visitors a month check its site, www.centerwatch.com.
Some caveats
Clinical trials are vital to medical progress, enabling doctors to treat and understand disease better. They can offer patients access to cutting-edge therapies and, because participants are supposed to be so strictly monitored, top-notch care.
But there are caveats. Patients may not get the experimental treatment, but a placebo or standard care for comparison. The research could be in such an early stage, or the person so sick, that the only reason to participate is to help future patients.
Or the experiment could fail or be harmful. Indeed, experts are questioning the oversight of clinical trials after a University of Pennsylvania gene-therapy experiment killed an Arizona teen-ager. The boy's father told Congress he was misled about the risks.
Consequently, getting involved can be a hard decision.
“It was very tough,” Patrick Cotter of Madison, Wis., said of enrolling his daughter Colleen, now 8, in a study of the drug Enbrel for juvenile rheumatoid arthritis. Standard medicines were helping Colleen, but they have very toxic long-term effects.
“It took us three months to decide,” but Colleen started testing Enbrel two years ago and is doing well. “It was the best thing we ever did.”
4,000 people per test
There is fierce competition for such patients. Pharmaceutical companies usually need some 4,000 people to test every experimental drug. Companies often pay doctors up to $2,500 for every patient they recruit into a hot study.
Making medical experiments more patient-friendly would help, says Elizabeth Moench of MediciGroup, citing a scientist who developed a special safety quiz for his clinical trial after too many patients forgot the risk warnings.
MediciGroup is working with the Internet polling company Harris Interactive and its database of 500,000 patients to help companies design better clinical trials and then fill them.
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