FDA pledges to listen to dissenting scientists

By Marc Kaufman and Brooke A. Masters
The Washington Post

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Without saying the agency had done anything wrong, acting Commissioner Lester Crawford outlined a series of steps the agency will take to become more aggressive about responding to reports of potentially harmful side effects.

The steps include establishing an internal program to ensure that the views of dissenting scientists are heard, a formal request to the National Academy of Sciences for a study of the agency's safety-monitoring procedures, and a renewed, nationwide search for a new director of the Office of Drug Safety. The position has been vacant for more than a year.

"We don't always understand the full magnitude of a drug's risks before it goes on the market," said Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research.

Galson, however, rejected criticisms that the Vioxx and antidepressant episodes — where FDA scientists accused superiors of suppressing warnings about the drugs — reflected a major problem with the agency's culture.

"It's a rarity," he said of the highly publicized disagreements. "It doesn't represent the culture, so we don't really think there is a need for an overwhelming cultural change."

Sen. Chuck Grassley, R-Iowa, chairman of the Senate Committee on Finance and recently a sharp critic of the FDA's actions, called the announcement "welcome, albeit late in coming."

"It's obvious that the leadership of the agency must take on what look like deep-rooted problems when it comes to putting public health and safety first and public relations second," Grassley said. "These initiatives need to take hold in a meaningful way and be more than an attempt to inoculate the agency in the face of alarming revelations."

Vioxx was taken off the market in September by Merck after a clinical trial using it was stopped because twice as many people taking the drug experienced cardiovascular disease than those taking a placebo. Several major medical journals have since published commentaries concluding that the drug should have been taken off the market earlier and criticizing the FDA for its role in keeping Vioxx on the market.

The agency also came under fire for its handling of internal reports about the possible increased risk of suicide among children prescribed antidepressants. After initially dismissing the link, the agency last month ordered all antidepressant drugs to carry a prominent "black box" warning to alert doctors that the medications can increase the risk of suicidal thoughts and behavior among children and adolescents.

As part of its effort to strengthen safety monitoring, the FDA will establish a formal program for agency scientists who disagree with decisions about specific drugs. The scientists will be able to present their views to a panel of FDA and outside experts, who would rule within 30 days.
 
In addition, the FDA will contract with the National Academy's Institute of Medicine to review the drug-safety system and assess how it can learn more about potential harmful side effects before the drugs become widely used. While defending the FDA's safety record, Galson said the agency would be open to changes recommended by the study.

Public-health advocates generally supported the FDA's initiatives, but the chief counsel of the Competitive Enterprise Institute, a nonprofit public-policy organization dedicated to the principles of limited government, questioned the changes.

"There's a real danger that the Vioxx situation will make the agency less willing to take any risk," said Sam Kazman, the chief counsel. "Historically, the agency suffers from deadly overcaution rather than recklessness, and has only been coming out of its shell in recent years. We don't want them to retreat again."

Merck officials declined to comment on the FDA's reform proposal, but they argued that the agency's initial press releases about the Vioxx withdrawal were very supportive of Merck's handling of the drug.

"Now people are looking at this through the prism of hindsight and there are people with agendas who leak information to influence the process," Merck general counsel Kenneth Frazier said.

Frazier and chief Merck spokeswoman Joan Wainwright said the company continues to believe it handled Vioxx appropriately.

An estimated 20 million Americans have taken Vioxx since the drug was approved, making the number of potential plaintiffs enormous. Some Wall Street research analysts have put Merck's potential liability above $10 billion, fueled in part by an FDA study that estimated Vioxx could be responsible for 27,000 deaths and the conclusion in this month's Lancet, a British medical journal, that the drug should have been pulled in 2001.