WHO Wants to Start Drug Trial Registry
Proposal to Be Made in November
By Shankar Vedantam
Washington Post Staff Writer
Thursday, July 8, 2004; Page A03
The World Health Organization wants to establish an international registry of drug trials to ensure that the public finds out when medications do not work, as well as when they do, officials said yesterday.
Pressure has been growing on pharmaceutical companies to fully disclose details of all clinical trials, not just those that support the use of their products. WHO officials said an international database, which would be modeled on registries in the United States and other countries, will be proposed to national health ministers at a meeting in November.
Full disclosure has gained momentum with the recent report that drug companies had not published the results of tests of antidepressant drugs that showed they were ineffective in treating children. Authorities say there is a similar bias against publishing negative results across all of medicine, with the result that the medical literature presents too rosy a picture about many drugs.
"When you go to do a systematic review, not all the data is out there in published form," said Kay Dickersin, director of the U.S. Cochrane Center, which periodically reviews the evidence for various medical treatments. "If what is unpublished is systematically negative, we have a problem with our knowledge base," she said.
Metin Gulmezoglu, a scientist at WHO's special program for research in human reproduction, said officials have not yet worked out how to enforce compliance with a global registry.
Individual governments have struggled for years to create registries. A recent report by the U.S. Food and Drug Administration found that many privately funded trials were not being registered as required with the U.S. registry created by a 1997 federal law, ClinicalTrials.gov.
The information that can be gleaned from registries is limited because none includes results of the trials or details of drug side effects. But experts say knowing the total number of trials can help researchers evaluate the merits of published studies.
"You look up all the trials, and say numbers one, eight, nine, seven were not published," said Drummond Rennie, a deputy editor at the Journal of the American Medical Association. "You can say every [published] trial we have shows that it works, but in 112 trials we have no answer, so we know it does not work."
Editors of several medical journals recently called for a trials registry.
Some companies have said they are amenable to disclosing the existence of trials. A registry could help avoid duplicating failed efforts and reduce the risk to volunteers and the cost of developing new drugs. But companies are also concerned that disclosure could endanger trade secrets.
Critics say drugmakers want to keep doctors and patients from getting the true picture about some medications because sales and profits could be affected.
While the current proposals call only for the registration of tests of a drug's effectiveness, Connie Ojile of Arlington said registries ought also to list safety studies -- known as Phase 1 trials -- to help desperate patients such as herself.
Ojile, 53, has a form of leukemia that has no current treatments. By chance, a doctor in New York recently told her about a Phase 1 trial in Texas that even Ojile's regular oncologist did not know about.
"I want to get the drug as soon as possible" even if its effectiveness has not been shown, she said, explaining that her cancer could quickly escalate and kill her. "Phase 1 can last six months, a year or 18 months. It's in my best interests as a patient with death on her shoulder to say, 'I'll try that.' What are my options?"
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