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Health - AP AP U.S. Creates Drug Safety Oversight Board
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By RANDOLPH E. SCHMID, Associated Press Writer
WASHINGTON - The government is setting up a special monitoring board to keep checking on medicines once they're on the market, responding to complaints that officials reacted too slowly to reports linking prescription painkillers to heart attack and stroke.
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Plans for the board were announced Tuesday on the eve of a three-day scientific meeting on the safety of painkillers such as Vioxx and Celebrex, drugs that blossomed into a $5 billion-a-year business before risks from potential side effects came to light.
Meanwhile, a medical journal questioned whether continued use of such products was justified.
Vioxx was pulled from the market in September after a study showed an increase in heart attacks and strokes among people using it. Other studies have also raised questions of heart problems with the similar drugs Celebrex and Bextra.
"Because there are well-established options for treatment of all the approved indications for these drugs, it is reasonable to ask whether the use of the drugs can now be justified," Dr. Jeffrey M. Drazen, editor of the New England Journal of Medicine (news - web sites), wrote in an editorial published online.
That is the question facing the Food and Drug Administration (news - web sites)'s arthritis and drug safety and risk management advisory committees at their meeting beginning Wednesday.
The new drug safety board was announced by Health and Human Services (news - web sites) Secretary Mike Leavitt, who said it has become clear that people want more oversight and openness from the FDA (news - web sites).
"They want to know what we know, what we do with information and why we do it," Leavitt said, promising to create "a new culture of openness and enhanced independence."
The board will recommend what information and updates to put on the government's Drug Watch, resolve disputes over drug safety issues, and oversee the development of a drug safety policy. It will include FDA employees and medical experts from other government agencies and will consult with outside medical experts as well as consumer and patient groups.
Lester M. Crawford, the acting FDA commissioner who was nominated Monday by President Bush (news - web sites) to assume the post permanently, said the agency now "understands that the public expects better and more prompt information."
Drazen's editorial was accompanied by three studies of these drugs, known as Cox-2 inhibitors, being released early by the journal.
The reports add detail to indications of heart problems associated with the drugs.
The prescription drugs have become widely popular pain killers for people with chronic conditions such as arthritis because they avoid the stomach and intestinal problems that have been associated with many other pain killers.
"Unfortunately," Drazen said in his editorial, "as the evidence began to suggest unexpected toxicity of this group of agents, the same zeal that had driven the clinical investigators to show their gastrointestinal safety was not evidenced by studies designed to show their cardiovascular safety."
The unexpected findings raise questions about the integrity of the American drug-safety system, according to a second editorial in the journal by researchers Bruce M. Psaty of the University of Washington and Curt D. Furberg of Wake Forest University.
"Physicians are dismayed, pharmaceutical companies are embarrassed and financially threatened, and patients are injured," they wrote.
Dr. Mark Fendrick, an internal medicine specialist at the University of Michigan, said a decision on the drugs "should be considered one of competing risk and benefits."
"Until we know for sure about the cardiological safety of the Cox-2 inhibitors, I believe they should be limited to those individuals who have a risk of stomach injury and those who are at low risk for cardiac problems," Fendrick said.
People who have a heart risk or who take aspirin to protect the heart should consider a traditional pain killer, he said.
Many people who take the Cox-2 drugs to avoid stomach problems also take aspirin to protect the heart, he noted, and that cancels the gastrointestinal protection of the Cox-2 drugs.
Associated Press Writer Laurie Kellman contributed to this report.