updated 11/5/2004 3:59:51 PM ET 2004-11-05T20:59:51

Buffeted by criticism, the Food and Drug Administration said Friday that it would appoint a director of drug safety and take other steps to improve the safety of medications.

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As sick and elderly Americans competed in lotteries for scarce flu vaccine, members of Congress chided the FDA for relying on the word of Chiron Corp., the vaccine manufacturer, rather than investigating as aggressively as British regulators.

Critics charge the agency ignored risks associated with antidepressants and the blockbuster drug Vioxx, then intimidated its own reviewers when they pointed to safety concerns in both cases.

Dr. Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, told reporters that a great majority of consultations with drug reviewers easily reach consensus.

Galson called the highly publicized disagreements so uncommon they don’t merit tweaking the agency’s culture to ensure dissenting views are heard.

“It’s a rarity. It doesn’t represent the culture, so we don’t really think there is a need for an overwhelming cultural change,” Galson said.

However, Dr. Eric Topol, the Cleveland Clinic cardiologist who pointed to increased cardiovascular risks with Vioxx in 2001, said he’s spoken to at least three other FDA researchers who complained the agency minimized their concerns about the drug.

“There has been a climate there ... of suppression of ideas and concerns,” Topol said.

Lester M. Crawford, acting FDA commissioner, said the agency’s stamp of approval means American drugs are the world’s safest. “The measures we are taking are designed to strengthen this quality as well as our consumers’ confidence that FDA’s processes ensure the highest protection of the public health,” he said in a statement.

Galson said the FDA will name a director of the Office of Drug Safety, vacant since October 2003, to oversee the safety of drugs after their approval.

Study on drug-safety oversight
In addition, the agency is asking the Institute of Medicine to study whether improvements are needed to tease out more about a drug’s side effects as it comes into more widespread use. The study also will examine whether the agency is too close to the drug industry to regulate it effectively.

The institute is an arm of the National Academy of Science, an independent agency chartered by Congress to advise the government on scientific matters.

“We are very proud of our independence,” Galson said. “We think most of the charges that have been leveled are just not accurate.”

Still, Dr. Wayne A. Ray, a Vanderbilt professor of preventive medicine, said the agency faces an internal conflict. One arm approves drugs, while the drug safety office tests the rigor of those decisions.

“Once the people in the reviewing decision approve a drug, there is a natural human tendency to not confront information that shows that decision might be faulty,” Ray said, renewing a call for an independent drug safety board.

To bridge differences among its scientific reviewers, the agency said it would convene an independent panel to review documents and make recommendations.

Acting commissioner Crawford said the FDA’S clinical reviewers and epidemiologists “evaluate and respond to identified concerns. This is what occurred recently with antidepressants and Vioxx.”

Yet, in both cases reviewers told members of Congress they faced resistance within the agency after raising alarms.

Agency accused of 'lethal weaknesses'
Consumer advocate Sidney Wolfe said he was cynical that Crawford would make meaningful changes, such as correcting the power imbalance that hobbles the drug safety office and making public dissenting reviewers’ comments. “This is an attempt to put up a cosmetic fix to a serious problem.”

This week, the FDA released a Sept. 30 memo from David Graham, the associate director for science, that said Vioxx safety concerns continued to mount after 2000. Besides heightened cardiovascular risks, the drug was linked to “significantly increased” risk of hospitalization for gastrointestinal bleeding.

Also, the editor of the journal The Lancet this week pointed to “lethal weaknesses” in FDA’s regulatory oversight. The FDA statement did not respond, directly, to the allegation.

Also, the editor of the journal Lancet this week lashed out at the FDA, pointing to “lethal weaknesses” in its regulatory oversight. “Unacceptable cardiovascular risks” with Vioxx were clear four years before Merck withdrew the drug, Lancet editor Richard Horton wrote.

“Too often, the FDA saw and continues to see the pharmaceutical industry as its customer — a vital source of funding for its activities — and not as a sector of society in need of strong regulation,” Horton wrote in the editorial.

The FDA statement did not directly respond to the Lancet criticism.

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