Friday, September 10, 2004

Societal crisis over credibility of drug company testing results?

The journal The Scientist reported on September 10, 2004 about a hearing on Sept. 9 of the House Energy and Commerce Subcommittee on Oversight and Investigations which was critical of the both the Food and Drug Administration (FDA) and pharmaceutical company officials concerning issues in failure to fully disclose clinical trial results. As the article notes, New York State Attorney General Spitzer has been active in this area.

The International Committee of Medical Journal Editors (ICMJE) said it would bar [from publication] data from trials that had not been registered–before enrolling any patients–in a free, open-to-the-public database that is managed by a nonprofit organization. Each trial file would include: protocols; definitions of outcomes; key trial dates; target number of subjects; funding source; and contact data for the principal investigator. According to the ICMJE, comes closest to its ideal.

PhRMA also has a registry proposal, which would be voluntary and will be online at

from the article-->

Representatives from GlaxoSmithKline, Forest Laboratories, Wyeth Pharmaceuticals, Eli Lilly, Bristol-Myers Squibb, Pfizer, and Organon USA all said they supported the PhRMA proposal and would participate. All the officials also said they had not had time to digest the AMA proposal, but were open to participation. Most said they were in the process of disclosing trial results on their own Web sites.

Both Forest and GlaxoSmithKline have been forced to create online registries through recent consent agreements with New York State Attorney General Eliot Spitzer.

John Hayes, an Eli Lilly product team leader, said Lilly will disclose full information about phase I, II, III, and post-marketing trials within a year of each study's completion. The company was motivated in part by bad press, he said: "There's a societal crisis in terms of the credibility of drug company results."

But, he said, there is a limit to what makes sense to make publicly available, noting that the company recently submitted a new drug application to the FDA that contained 417,000 pages, much of it raw data.

Waxman said he and colleague Edward Markey (D-Mass.) would not wait for voluntary efforts to pan out, but instead will soon introduce legislation to make it mandatory to register trials at The bill would also incorporate recommendations from the ICMJE and the AMA.


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