|
|
Seeking to defuse criticism that pharmaceutical companies hush up negative results in clinical trials, U.S. drug maker Eli Lilly & Co. plans to disclose extensive data on almost all clinical trials, past and present, for the drugs it sells.
Under the new policy, once a drug is on the market, Indianapolis-based Lilly will publish data from all early to late-stage clinical trials, including safety information and outcomes. Test results that did not support the hypothesis or that were contrary to the expected outcome also will be disclosed, the company says. Results of trials on unapproved uses of medicines -- known as off-label use -- also will be available.
Lilly's plan, expected to be in place by the end of the year, goes beyond the more limited and less detailed policies announced by other drug companies. Lilly plans to offer access to data from all phases of its clinical trials while other drug companies haven't decided if they'll publish the same amount of information or just the later-phase trials. Lilly's policy could spur other drug makers to follow suit.
Drug companies have long been criticized for selectively releasing data from clinical trials. Companies typically trumpeted studies that were favorable for a given drug and quietly shelved those that showed side effects, safety problems or raised questions about the drug's effectiveness.
Alan Breier, Lilly's chief medical officer, says the company decided to publish such trial details because the "the public is demanding greater openness." Dr. Breier also says that Lilly wanted to be certain that its medicines were being used properly. "Patient care is served best by open disclosure," he says.
GETTING RESULTS Outcomes from some clinical trials for antidepressant use in children have not been published to date.
DRUG TOTAL # TRIALS UNPUBLISHED
Prozac/Eli Lilly 6 2
Paxil/GlaxoSmithKline 7 2
Zoloft/Pfizer 5 1
Celexa/Forest 3 3
Effexor/Wyeth 2 2
Source: The Lancet, April 2004
Lilly's trials will be published on a company Web site open to the public.
In June, the American Medical Association called for all drug companies' trials to be registered with the federal government (they aren't currently). While the AMA didn't offer a specific outline, it said a government-run system that tracks data from all clinical trials would help make the research more open to the public.
The AMA also wants trials of experimental drugs to be disclosed -- something the drug industry opposes because of concerns that competitors would learn their research and development secrets. Lilly won't publish results of trials on drugs that aren't yet approved, but it will list on its Web site when late-stage trials are to begin.
Questions about the safety of antidepressants in children have brought the issue of medical disclosure to a head. Doctors and regulators were stymied by incomplete public data as they weighed whether children taking antidepressants were initially at greater risk of suicide. Doctors couldn't see the results of tests that drug companies had done with children, even as prescriptions for the young ballooned. In June, New York State Attorney General Eliot Spitzer sued GlaxoSmithKline PLC, alleging that the company concealed efficacy and safety in tests done with children and the company's blockbuster drug Paxil for treating depression. The lawsuit is continuing.
To quell the furor, several drug makers have pledged broader disclosure. Glaxo released all its Paxil data on its Web site (the company says the move was not in connection with the lawsuit) and said it would disclose data from trials of all its marketed products. Glaxo is still hashing out what kind of information will be disclosed and declined to comment on its plan. Merck & Co. has indicated that it would support a government-run listing system, and pledged more openness -- but only about late-stage clinical trials or postapproval tests. Johnson & Johnson also said it supported the idea of a clinical trials registry.
Federal law requires drug companies to list all studies done in serious or life-threatening illnesses on the public Web site ClinicalTrials.gov. The site does not provide any results of trials because it is geared to people looking to enlist in studies.
Lilly says it will release historical information for all of the drugs it now sells going back 10 years. Dr. Breier says that such retrospective data on drugs already on the market immediately help doctors in prescribing medication for patients. Despite ongoing litigation, Lilly plans to release historical data on Zyprexa, the blockbuster antipsychotic that brings in a third of the company's revenues. Zyprexa was at the center of a debate last year over whether antipsychotic drugs cause weight gain and increase the risk of diabetes. Lawsuits involving Zyprexa are getting under way in federal and state courts. Lilly's Dr. Breier says the company isn't concerned that it's giving plaintiffs' lawyers an edge in the litigation because much of the data already has been published.
In another new approach, Lilly says it will rely on a third-party auditor to monitor its adherence to the policies, something no other company has said it would do. Lilly also pledged to notify the public when it begins a trial that will later be included in the application submitted to the Food and Drug Administration for approval or when it will conduct a postmarketing study that explores using the drug for another disorder -- both moves aren't common practice in the industry.
That move would make it easier for patients to locate clinical trials to join, and as act an "accountability check" to ensure that Lilly actually publicized all results when the trial ended. Some lawmakers and associations of medical journal editors and doctors have called for all companies to disclose such information. After a drug comes to market, companies aren't required to publish or give the FDA further test results on a drug's effectiveness for other conditions or if it was studied on special populations, such as children. Lilly will publish its clinical trial results for unapproved uses. Lilly's antidepressant Prozac was the only one that received FDA approval for use in children with depression. Dr. Breier says Lilly will release its tests of Prozac in kids on its Web site.
Since doctors frequently prescribe drugs for unapproved uses, more information would help them in treating patients. For example, Lilly's antipsychotic drug, Zyprexa, is widely prescribed for hard-to-treat cases of depression and dementia in the elderly. Yet there haven't been any large-scale studies to determine whether Zyprexa works in those disorders. A clinical trial registry along the lines of Lilly's plan would let doctors know if the company had ever done tests of Zyprexa for unapproved uses -- and what the results were.
Write to Leila Abboud at leila.abboud@wsj.com.
|
