House Members Criticize FDA Officials for Alleged Intimidation
Rep. Bart Stupak (D-Mich.) on Friday circulated a letter addressed to FDA acting Commissioner Lester Crawford and signed by 22 House members that requested information on allegations that FDA Office of Drug Safety Associate Director David Graham has faced intimidation and threats by agency officials, the AP/Atlanta Journal-Constitution reports (Recer, AP/Atlanta Journal-Constitution, 12/11). Last month, Graham testified at a Senate Finance Committee hearing that Merck should have withdrawn the COX-2 inhibitor Vioxx from the market years earlier than late September and criticized agency actions related to the medication. Merck withdrew Vioxx over safety concerns.
Graham also said that FDA, "as currently configured, is incapable of protecting America against another Vioxx" because of ties between agency reviewers and the pharmaceutical industry. Since the hearing, Graham has said that he has faced pressure to change positions within FDA as a retaliatory measure. Graham said that he informed Crawford that he was not interested in the new position. In addition, Tom Devine, legal director for the Government Accountability Project -- which has provided legal counsel for Graham -- said that after Graham retained GAP attorneys, the group received anonymous telephone calls from alleged FDA employees who sought to discredit Graham (California Healthline, 12/6).
House members sent the letter to Crawford to "to express [their] strong dismay at recent reports about efforts taken by some at FDA to discredit and smear Dr. Graham." The letter said, "This shameful behavior by management cannot continue, and we demand you put a stop to it." The letter also stated that if the allegations are accurate, they are "out of line and may very well be illegal," adding, "Your treatment of Dr. Graham 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 also requests a guarantee that Graham will retain his current position at FDA (AP/Atlanta Journal-Constitution, 12/11). In addition, the letter asks Crawford to investigate the allegations (USA Today, 12/13). FDA spokesperson Kathleen Quinn said that the agency would not comment on the letter (AP/Atlanta Journal-Constitution, 12/11).
Two newspapers recently published articles related to the Vioxx withdrawal. Summaries of the articles appear below.
Bergen Record: The Record on Sunday examined how the Vioxx withdrawal "was just the latest and largest in a series of setbacks" for Merck that could affect the long-term profitability of the company. In addition to financial concerns, company officials must address issues related to "Merck's reputation for scientific excellence" and "questions about its ethics," the Record reports. The article includes a timeline of the profit and regulatory history of Merck and discusses the products that the company hopes to market in the future (Krauskopf, Bergen Record, 12/12).
Long Island Newsday: Newsday on Monday examined how some experts predict that lawsuits related to the Vioxx withdrawal "may be difficult to prove." At the end of October, Merck faced 375 lawsuits in a number of states that included 1,000 plaintiff groups (Kerr, Long Island Newsday, 12/13).