Eli Lilly Announces Plans To Post Data on Past and Present Clinical Trials on its Web Site
Eli Lilly officials announced plans to release on the company's Web site "extensive" data on all phases of clinical trials conducted on most of Lilly's products, the Wall Street Journal reports. The move is an effort to "defuse criticism that pharmaceutical companies hush up negative results," according to the Journal. Under the new policy, once a drug receives FDA approval and reaches the market, Lilly will release all clinical trial data from early to late-stage phases. It will also release trial data from the past 10 years on all products currently available. Test results that did not support the trials' hypotheses and results on off-label uses of medicine will also be disclosed. The company will not publish the results of trials on drugs that have not yet been approved but will list on its Web site when late-stage trials are scheduled to begin.
In addition, Lilly plans to notify the public when it begins a trial that could later be included in an application for FDA approval, which company officials said is intended as an "accountability check" to ensure the company publicizes all trial results. They added that the postings will make it easier for people to participate in trials. Lilly officials also said the company plans to use a third-party auditor to monitor its adherence to the new polices, which are expected to be implemented by the end of the year. Specifically, Lilly officials said the company intends to release historical data on its antipsychotic drug Zyprexa, which comprises one-third of the company's revenue. Some clinicians have contended that Zyprexa can cause weight gain and increased risk for diabetes. The company will also release its data on the effect of Prozac on children. Lilly Chief Medical Officer Alan Breier said the company plans to implement the policy because "the public is demanding greater openness." He added, "Patient care is served best by open disclosure" (Abboud, Wall Street Journal, 8/3).
The announcement comes after many lawmakers, medical professionals and medical journal editors in recent months have called on pharmaceutical companies to disclose both positive and negative findings of clinical trials. World Health Organization officials last month said they plan to propose an international clinical trial registry, modeled after similar databases in the United States and other nations, to national health ministers at a November meeting. In addition, the American Medical Association in June approved a resolution that calls on the federal government to establish a new national database.
Pharmaceutical companies currently must submit all clinical trial results to FDA, but the agency cannot disclose all of the information, which is considered proprietary. FDA officials in most cases must obtain consent from pharmaceutical companies before they can make clinical trial results public. Some drug companies have raised concerns about the effect of such a registry on trade secrets (California Healthline, 7/9).
Lilly's plan "goes beyond the more limited and less detailed policies announced by other drug companies" and could "spur other drug makers to follow suit," the Journal reports. GlaxoSmithKline officials have said the company will disclose data from trials of all marketed products. GSK officials are "still hashing out what kind of information will be disclosed" and would not comment, the Journal reports. Merck officials indicated support for a government-run clinical trial database and has "pledged more openness" about late-stage or postapproval trials only, according to the Journal. Representatives for Johnson & Johnson have also said the company supports a clinical trial registry (Wall Street Journal, 8/3).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.