The industry researcher explained that the studies that are the basis for regulatory approval are too small and are conducted over too brief a period to properly assess safety. There are "blockbuster drugs" out there, said the scientist, that "might be associated with tens of thousands of deaths a year" but this risk "would never be detected in studies of the kind that we routinely submit and are the basis for approval. These drugs are essentially out there now, unlabeled, unnoticed, all beneath the radar."

Lenzer's account captures some of the ways in which industry may influence not only which drugs get approved, but also which drugs get prescribed.

One of the roundtable whistleblowers was Allen Jones, a former investigator at the Pennsylvania Office of the Inspector General, who filed a civil rights lawsuit on November 22 2002 "to preserve my job and my right to speak out."

Jones explained that he had investigated an account into which pharmaceutical companies were paying money that was being accessed by state officials. These officials "were given unrestricted educational grants that were deposited into an off-the-books account - unregistered, unmonitored, literally operated out of a drawer." The officials, he said, were responsible for writing guidelines for the treatment of patients in the state system and were receiving money from companies with a stake in these guidelines.

The marketing tactics used by drug companies came under scrutiny at the roundtable. Kathleen Slattery-Moschkau, a former drug representative who wrote and directed the movie Side Effects, a fictionalized account of her experiences, explained how companies bought doctors' prescr
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Contact: Paul Ocampo
press@plos.org
+1-415-624-1224
Public Library of Science
27-May-2005