Congress Members Demand Answers from

FDA about Whistleblower

Twenty-two members of Congress signed a letter Friday demanding information on reports that FDA whistleblower David Graham was being punished by Food and Drug Administration officials for his outspoken testimony before a Senate committee.

The letter, circulated by Rep. Bart Stupak, D-Mich., and sent to acting FDA head Lester M. Crawford, said the members of Congress wanted "to express our strong dismay at recent reports about efforts taken by some at FDA to discredit and smear Dr. Graham."

"This shameful behavior by management cannot continue and we demand you put a stop to it," the letter said.

Graham, who works in the FDA's office of drug safety, testified before a Senate committee last month that the FDA fumbled in its handling of the arthritis drug Vioxx, which is made by Merck & Co., and had mishandled safety problems with five other widely used drugs.

The FDA rebutted Graham's testimony with filings on the agency Web site. An FDA official also sent e-mail messages to the medical journal Lancet expressing concerns about a Vioxx study by Graham that the journal was preparing to publish. Eventually, Graham withdrew the paper after he could not obtain a clear approval from the FDA for its publication.

Additionally, the Government Accountability Project, a whistleblower support group, said Graham was the target of "rabid bureaucratic backlash." The head of the organization said FDA managers phoned with accusations of scientific misconduct against Graham.

In the letter sent to Crawford, the members of Congress said that if reports of these actions against Graham are true, then they are "out of line and may very well be illegal."

"Your treatment of Dr. Graham," the letter said, "undoubtedly has had a chilling effect on the willingness of FDA employees to speak up and disagree when they believe the public's health is at risk."

The letter asked for assurances that Graham will keep his job in the office of drug safety and that "the smear campaign waged by some within the agency is thoroughly investigated and that appropriate action is taken against those who were involved."

Kathleen Quinn, a spokesperson for the FDA, said the agency would not comment.

"The FDA does not common on personnel matters," she said.

In addition to Stupak, those signing the letter were Reps. Chris Smith, R-N.J.; Dan Burton, R-N.J.; Sherrod Brown, D-Ohio; Ed Markey, D-Mass.; Rosa DeLauro, D-Conn.; Elliot Engel, D, N.Y.; G. K. Butterfield, D-N.C.; Pete Stark, D-Cal.; David Obey, D-Wis.; James Oberstar, D-Minn.; Carolyn Kilpatrick, D-Mich.; Jim Moran, D-Va.; Donald Payne, D-N.J.; Gary Ackerman, D-N.Y.; Anthony Weiner, D-N.Y.; Jim McGovern, D-Mass.; Betty McCollum, D-Minn.; Susan Davis, D-Cal.; Jan Schakowsky, D-Ill.; John Conyers, D-Mich., and C.A. Ruppersberge, D-Md.