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| Saturday, November 06, 2004 -
FDA pledges to listen to dissenting scientists
By Marc Kaufman and Brooke A. Masters
The Washington Post
WASHINGTON — Responding to continuing criticism that it mishandled
internal warnings that the painkiller Vioxx had deadly side effects
and that antidepressants were being misprescribed for children, the
Food and Drug Administration announced yesterday that it would
strengthen its system for reviewing the safety of drugs already on the
market.
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.
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Copyright © 2004 The Seattle Times Company
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