New panel will check on risks of drugs after government OK
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 have reacted too slowly to reports linking prescription painkillers to heart attack and stroke.
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 raised questions of heart problems with the 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 Drazen, editor of the New England Journal of Medicine, wrote in an editorial published online.
That is the question facing the Food and Drug Administration’s arthritis and drug safety and risk management advisory committees at their meeting beginning today. The safety board was announced by Health and Human Services Secretary Mike Leavitt, who said it has become clear that people want more oversight and openness from the FDA.
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 and patient groups.
Lester Crawford, acting FDA commissioner who was nominated Monday by President Bush 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. The reports add detail to indications of heart problems associated with the drugs. The prescription drugs have become widely popular painkillers for people with chronic conditions such as arthritis because they avoid stomach and intestinal problems that have been associated with other painkillers.
“Unfortunately,” Drazen wrote, “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 findings raise questions about the integrity of the U.S. drug-safety system, according to a second editorial in the journal by researchers Bruce Psaty of the University of Washington and Curt Furberg of Wake Forest University.
“Physicians are dismayed, pharmaceutical companies are embarrassed and financially threatened, and patients are injured,” they wrote.