Advocates Pursue
When can a well-designed clinical trial provide only minimal help in evaluating a new drug? It is when the trial’s results go unreported.
Medical journals are filled with reports on the safety and effectiveness of new medications, but they represent only a portion of all the studies conducted. For the most part, published reports reflect the exciting news about drugs that show therapeutic promise. Studies that cast doubt on the value of new medicines are less likely to find their way into print, but the bad news can be as important as the good news in making clinical decisions.
THE IMPERFECT STATE OF CLINICAL TRIAL DISCLOSURE
The paucity of reported negative findings can be a disadvantage to physicians and their patients when they need to weigh treatment options. They may not know of suspected safety hazards or of the questionable effectiveness of some widely used medications in population subgroups. They also may not be able to accurately assess the promise of entering a trial of an experimental drug.
This dilemma reached widespread public notice recently, when the New York State Attorney General sued Glaxo-SmithKline for not publishing unfavorable studies on the use of its antidepres-sant paroxetine (Paxil drug) in children. British medical authorities had suggested that generic paroxetine might actually exacerbate pediatric depression and increase the risk of suicide.
When the Food and Drug Administration (FDA) initially reviews a new drug, it considers the results of all studies, both positive and negative. These results then become available to the public. However, when the agency denies a manufacturer’s subsequent request that the drug be approved for a new indication or for a labeling change, it does not publicly acknowledge any of the new data submitted, even if the data reveal previously unreported safety risks. It is up to the manufacturer to decide which of these results find their way into the public domain or onto the product’s label.
A PUBLIC REGISTRY AS A SOLUTION
One solution to the problem of disclosure, according to several health care organizations, is to require a listing of all clinical trials and their results in a public registry. Physicians, patients, and even regulators would then stand a better chance of seeing all the findings and of making more informed decisions. The American Medical Association has proposed that a registry be maintained by the Department of Health and Human Services (DHHS), the European Science Foundation has recommended a registry for trials across Europe, and the World Health Organization plans to propose a worldwide registry of its own. One large drug company, Merck, has endorsed the idea as well.
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An intriguing proposal is under consideration by the International Council of Medical Journal Editors, a group representing 12 of the most prestigious medical publications, including The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, and The Annals of Internal Medicine. The journals would require that pharmaceutical companies register clinical trials, at their start, in a public database, or the results would not be eligible for publication. Because manufacturers often point to published results in prestigious journals in marketing their drugs, the incentive to participate in the registry would be significant.
The pharmaceutical industry itself has shown increasing receptiveness to fuller disclosure of clinical trial results. Pharmaceutical Research and Manufacturers of America (PhRMA) recently issued voluntary guidelines for trials that include a directive that meaningful study results be communicated in a timely manner regardless of the outcome. In response to the lawsuit concerning paroxetine canadian, GlaxoSmithKline posted all clinical findings related to the drug. As noted, Merck has publicly endorsed the creation of a registry, although it would be limited to late-phase and post-approval studies.
Eli Lilly recently announced the most ambitious initiative among pharmaceutical manufacturers. Starting late next year, it plans to publish, on a Web site, all clinical trial data from all phases of testing for its approved drugs, including the results of trials for off-label uses.
