December 22,2005

Chairman Grassley says review will continue into allegations of problems with human subject drug research

WASHINGTON — Sen. Chuck Grassley said today that the Finance Committee will continue its review of allegations about abusive practices in human subject research of pharmaceutical drugs.

Consideration by the Senate committee began after news reports by Bloomberg News describing practices that have left people participating in the studies uninformed and at risk, in addition to potentially compromising the pharmaceutical test results. Bloomberg reported that following its first news report in early November, one of the companies, SFBC International, Inc. (SFBC), retaliated against three SFBC research participants who were cited in the report. On November 17, Grassley sent a letter requesting a meeting with the CEO of SFBC to discuss the allegations.

Last week, SFBC delivered a report to Grassley titled “Report to Senator Grassley from the Independent Counsel to the Board of Directors of SFBC International, Inc. Concerning Allegations Related to SFBC in Bloomberg’s November 2, 2005 Article, ‘Big Pharma’s Shameful Secret,’ and Bloomberg’s Related Article of November 16, 2005.” While the report disputes Bloomberg’s allegations, it also confirmed that the behavior of some SFBC personnel was “inappropriate.”

Last week, Grassley sent another letter to SFBC seeking additional in-person meetings with top SFBC officials, including the Director of Legal Affairs. The Finance Committee was subsequently informed that SFBC’s Director of Legal Affairs had recently resigned.

“There are questions to be answered about the actions of the company and the departure of the company’s Director of Legal Affairs related to the allegations made in the Bloomberg news reports,” Grassley said. “The integrity of drug research that’s conducted with people who subject themselves to the tests cannot be compromised. Mistreatment of test subjects is unethical, and if the process is flawed, the test results are not reliable.”

Copies of the two letters that Grassley sent to the SFBC are attached to this news release, along with a letter he sent to the Food and Drug Administration on the same matter and his correspondence with the Inspector General for the Department of Health and Human Services regarding its recommendations relating to human drug testing practices.