Healthy Skepticism Library item: 1602

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Editorial .
Hiding the Data on Drug Trials
The New York Times 2005 Jun 1;

Full text:

Any Americans gullible enough to believe that the drug industry can be trusted to report fully on what clinical trials it is sponsoring or what results were found must be sorely disappointed by recent developments. A government survey determined that three of the largest drug companies have effectively reneged on their pledges to list trials in a federal database. A report in yesterday’s Times by Alex Berenson reveals that this intransigence also extends to a voluntary industry database. It looks as if demands from researchers and the medical profession for full access to clinical trial data will continue to be frustrated.

Companies already provide the data to the Food and Drug Administration, which is required to keep much of it confidential. A public listing of trials is important to prevent drug makers from hiding results that reflect badly on their drugs while publishing only results that make their drugs look good. By law, the companies are supposed to register important trials with a government Web site. Most manufacturers are complying, but the three big obfuscators – Merck, GlaxoSmithKline and Pfizer – are often getting around the requirement by not naming the drugs they are testing, instead using phrases like “an investigational drug.” Merck was the worst offender, failing to provide a drug’s name some 90 percent of the time. Glaxo withheld a name 53 percent of the time, and Pfizer 36 percent of the time.

Merck and Pfizer are also the most prominent withholders of trial results from the industry’s voluntary database. As Mr. Berenson reported, Pfizer has posted only a few results of clinical trials, and Merck has posted none.
That meager contribution appears to satisfy the weak guidelines set by the industry, but it offers a sorry contrast with the record of Eli Lilly. Lilly appears to have been quite scrupulous in listing its current trials with the government site and has posted the results of hundreds of completed clinical trials on the industry site. Surely if one big company can make its trials transparent, other drug makers can do the same.

A coalition of medical editors has just stiffened its announcement that leading journals will soon refuse to publish the results of any clinical trial that has not complied with tough international standards for transparency. That should apply useful pressure to recalcitrant companies.
But the best hammer would be federal legislation to compel all companies to provide critical information when a trial is begun and full results when a trial is completed, with stiff penalties for noncompliance.