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Crisis deepens at the US Food and Drug Administration

BMJ 2004; 329 doi: (Published 02 December 2004) Cite this as: BMJ 2004;329:1308
  1. Jeanne Lenzer
  1. New York

    The US Food and Drug Administration, rocked by controversy in recent months, has now admitted that a senior management official secretly contacted a whistleblower group. That official attempted to discredit Dr David Graham, the FDA's scientist who criticised the agency during US Senate hearings, saying that the FDA failed to protect the public when it approved rofecoxib (Vioxx, Merck)—despite evidence suggesting that the drug caused heart attacks and strokes (BMJ 2004;329: 1255, 27 Nov).

    The FDA issued a statement on 26 November saying, “FDA had no prior knowledge of any employee's contact with the Government Accountability Project.” In addition to acknowledging that the employee is “not anonymous” to the project, the FDA said the “employee has chosen to not divulge their identity, and FDA respects the right of any of its employees to protect their privacy in cases such as this.”

    Dr Graham's attorney, Tom Devine, …

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