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Pharma Should Publish Its Trial Results

I recently listened to a panel discussion on the future of biomedical science. The standout participant, an urbane and knowledgeable contributor, was the CEO of a major pharmaceutical company. He won the audience over with his optimistic vision for the future of drug development, his conviction of the necessity of collaboration between academia and industry, and his characterization of the high ethical standards that his company and the industry in general have met.My interest piqued by this and

By | April 26, 2004

I recently listened to a panel discussion on the future of biomedical science. The standout participant, an urbane and knowledgeable contributor, was the CEO of a major pharmaceutical company. He won the audience over with his optimistic vision for the future of drug development, his conviction of the necessity of collaboration between academia and industry, and his characterization of the high ethical standards that his company and the industry in general have met.

My interest piqued by this and by our reporters' work on clinical trials (see the Feature on p. 20), I dug out the ethical principles1 adopted by PhRMA (the Pharmaceutical Researchers and Manufacturers of America), the representative body of the industry. Among the provisions:

"There will be timely communication of meaningful study results, regardless of the outcome of the study. The results must be reported in an objective, accurate, balanced, and complete manner, with a discussion of the limitations of the study. Study sponsors will not suppress or veto publications."

I was thunderstruck, given that an issue muddying the current debate about the use of antidepressants in children is the lack of access to trial results. As reported in The Washington Times on Jan. 29, "Makers of popular antidepressants such as Paxil, Zoloft, and Effexor have refused to disclose the details of most clinical trials involving depressed children, denying doctors and parents crucial evidence as they weigh fresh fears that such medicines may cause some children to become suicidal."

While this situation has now been rectified, the obvious question, namely why all clinical trial results are not available as a matter of course, has a frustrating answer: The results are the closely guarded property of the drug companies. The decision on when and how to make them available rests entirely with the companies, to the extent that US Rep. James Greenwood (R-Pa.), chairman of the Subcommittee on Oversight and Investigations, had to politely request unpublished data on the antidepressant trials.2

Here are a couple of extracts, taken from the published documents of more than one company. They do not exactly jibe with the PhRMA principles.

"Company X recognizes that the availability of clinical trial results is critical to the communication of important new information for the medical profession, patients, and the public."

Hurrah!

"Company X commits to timely communication of meaningful results ..."

Yes?

"... of controlled clinical trials of marketed products or investigational products that are approved for marketing, regardless of outcome."

Well, what about the antidepressant shenanigans? And what about data from the innumerable trials that fail? These, too, are of vital importance.

"For investigational candidates that fail in development, Company X will collaborate with external investigators to publish the findings based on priorities and on the medical and scientific importance of the data."

Whose priorities? And what are the criteria for medical and scientific importance?

Common sense dictates that innovation by the pharmaceutical industry must be encouraged and protected, otherwise the current, unprecedented opportunities to create new medicines will not be realized. But withholding clinical trial results serves this function at the expense of a wider goal, namely the development of medical knowledge.

Not only should trial results be made available, they should also be done so in a standardized structure on searchable databases, as occurs in many areas of basic biology research. A proposal for such a database was made as long ago as 1996,3 but it has been unable to get off the ground.

Opening up clinical trial results to researchers would serve Pharma as well as society. Companies could be protected by confidentiality agreements, and reach-through rights would help hasten the development of new medicines.

This surely would be in close accord with the admirable principles set forth by PhRMA. It is time to implement them.

Richard Gallagher, Editor rgallagher@the-scientist.com

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