Vioxx recall exposes the mess at FDA

Since the recall of Vioxx by Merck in late September, no one has come forward yet to take responsibility for the deaths of tens of thousands of Americans and injuries to many more. While Merck has taken a highly antagonistic approach and has started a coordinated program of attack against Vioxx victims, FDA has either defended its role or sided with Merck's position. Adding to the misery of Vioxx victims, the White House announced yesterday that they want to completely rewrite the laws of the United States so that victims of Vioxx (or for that matter any other product that kills of injures Americans) will lose their legal rights to file class action lawsuits or to demand any compensation from companies. Not surprisingly enough, the legislation is strongly supported and being pushed by businesses.

When Dr. David Graham, an expert at the FDA, exposed during hearings at Congress (what was already well known among American scientists) that the FDA was an agency in a mess, that there were four other Vioxx like drugs on the market that Americans take without thinking about their side effects, and that the agency was incapable of ensuring the safety of drugs sold in the United States, he was strongly criticized by his colleagues at the FDA, who started a coordinated campaign to discredit. Dr. Graham is fighting to keep his job and would have lost it already without the interference of Senator Chuck Grassley and others in Congress.

But it looks as if Dr. David Graham was essentially lending a voice to his colleagues at the FDA. In a previously unpublished internal survey of Food and Drug Administration scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs, according to documents jointly released by the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER). The FDA survey results, obtained under the Freedom of Information Act, closely track the safety concerns raised by the agency’s own Associate Director for Science and Medicine, Dr. David Graham, in testimony before the U.S. Senate last month. (Related article: Vioxx recall mess shows that fundamental changes may be needed at the FDA)

The Health and Human Services Office of Inspector General conducted the survey in late 2002 as part of a management review of how the agency was meeting stringent deadlines for approving new drugs. OIG polled 846 FDA scientists, with nearly half (47%) completing the survey. Survey findings included:

• Two-thirds (66%) of respondents lacked confidence that the agency “adequately monitors the safety of prescription drugs once they are on the market;”
• Only 12% of scientists were completely confident that FDA “labeling decisions adequately address key safety concerns” while 30% were not at all or only somewhat confident;
• More than one third (36%) of scientists were not at all or only somewhat confident that “final decisions adequately assess the safety of a drug”; and
• Nearly one in five scientists (18%) said that they “have been pressured to approve or recommend approval” for a drug “despite reservations about the safety, efficacy or quality of the drug.”

Despite the disquieting survey results, when the OIG published its report in March 2003, a lead conclusion was that FDA scientific reviewers “have high confidence in decisions FDA makes.”
“The survey raises significant issues about drug safety and ongoing monitoring of adverse health impacts of drugs in the marketplace,” stated Kathleen Rest, executive director of UCS. “The scientists concerns warrant further investigation as Congress reviews drug approval practices at FDA.” (Related article: How did Vioxx become toothless?)

The fact that Dr. Graham’s supervisors have publicly disparaged his testimony highlights a weakness in FDA’s ability to dispassionately resolve scientific differences. In the survey of scientists, less than one in five (17%) felt the agency had “adequate procedures in place to address scientific disagreements” to a “great extent,” while 45% felt adequate procedures existed only to “some extent” and more than a third (38%) said procedures for resolving dissent existed only to a “small extent” or “not at all.”

“By all appearances, FDA would rather be sorry than safe,” stated PEER Program Director Rebecca Roose who obtained the survey under the Freedom of Information Act. “These results show that many of Dr. Graham’s colleagues share his concerns, but that those warnings are falling on deaf ears.”

Recommended article: FDA is a lapdog of the drug industry