The ‘Dangerous Drugstore’

To the Editors:

In the June 8 issue, Marcia Angell’s piece [“Your Dangerous Drugstore”] urges greater transparency in the prescription drug industry, including registration of human trials in a publicly available database, with salient results added at trial completion.

In the recent settlement of class action litigation which we brought on behalf of shareholders against Bristol-Myers Squibb, we achieved the disclosure that Dr. Angell urges. In addition to funding a $185 million settlement for shareholders, BMS agreed to publicly disclose on its Web site a description of its clinical trials, trial results, and safety results, including reporting of adverse events seen during the trials. As a result, for the first time, anyone taking a drug manufactured by BMS will have instant access to crucial information about the drug, especially serious side effects.

The reforms achieved in the BMS litigation implement many provisions of the proposed Fair Access to Clinical Trials Act of 2005, a bill introduced in the House of Representatives and in the Senate, but which has not been passed to date, to which Dr. Angell alludes. We agree with Dr. Angell that when unfavorable trial results are hidden, consumers are led to believe that drugs are safer than they in fact are. Transparency of clinical trials is a critical requisite for an informed population of doctors, patients, consumers, and shareholders. In addition, we believe this example shows how the class action process can bring about important policy changes as well as providing investor compensation.

Thomas A. Dubbs

Partner

Labaton Sucharow & Rudoff LLP

New York City

Marcia Angell replies:

The agreement between Mr. Dubbs’s firm and Bristol-Myers Squibb, which I can well imagine was hard won (the company touts its “disclosure commitment” on its Web site without mentioning the class action settlement), is a step in the right direction, but there are important loopholes. For example, results need only be disclosed for clinical trials of drugs already on the market, not trials performed to get marketing approval from the FDA in the first place, and disclosure may be delayed for up to two years, and perhaps even longer under certain circumstances. And, of course, the agreement involves just one company.

What is needed is a statute that would require all drug companies to register all clinical trials at inception in a central, publicly administered database (not just the company’s own Web site), as a condition of enrolling human subjects. Registration should include enough details about how the proposed study will be performed to make it impossible to alter the trial in midstream to emphasize emerging positive results and suppress negative ones. When a trial is completed, the major results should be added without delay.

Companies protest that disclosing results before FDA approval would jeopardize their competitive position, but that is not a persuasive argument. Drugs are almost always patented well before clinical trials begin, so disclosure would not permit competitors to beat a company to the patent office. It is conceivable, though not likely, that competitors might learn sooner than they otherwise would about pitfalls to avoid in developing similar drugs; but that would be a gain for the public that should outweigh any proprietary interest. I can only conclude that drug companies’ resistance to registering all trials and promptly disclosing results means they have something to hide.