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Independent Board to Monitor Drugs Already on Market

Posted on: Thursday, 17 February 2005, 15:00 CST

As federal advisory panels begin three days of meetings today on the safety of painkillers such as Celebrex and Vioxx, the government announced it is creating a board to monitor drugs that are already on the market.

Meanwhile, a leading medical journal on Tuesday released three studies that add to a growing body of evidence linking the popular class of painkillers including Celebrex to increased risk of heart problems.

The newly created independent Drug Safety Oversight Board will monitor drugs already approved by the Food and Drug Administration, including notifying physicians and the public on drug risks and benefits through a new Drug Watch Web page.

The board members, appointed by the FDA commissioner, will include FDA officials and medical experts from other agencies and departments such as Veterans Affairs. The board will consult with outside experts and patient groups.

Health and Human Services Secretary Mike Leavitt said the board is meant to foster "a new culture of openness and enhanced independence." The FDA is under intense criticism for not addressing the link between certain painkillers and heart problems quickly enough.

Dr. David Campen, Kaiser Permanente's medical director of pharmacy services, said the drug safety board is a step in the right direction, but its success is in the details.

"A lot will depend on what authority that board has and the constituency of that board," he said.

Merck pulled its blockbuster pain drug Vioxx from the market in September after a study indicated long-term use doubled the risk of heart attacks and strokes. The move — along with studies suggesting heart problems related to similar drugs Celebrex and Bextra — led the FDA to convene the advisory panel meetings.

The Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee at the FDA will discuss risks and benefits of these drugs, known as Cox-2 inhibitors, in the next three days. Cox-2 inhibitors have become widely popular painkillers for people with chronic conditions such as arthritis because they avoid stomach problems associated with ibuprofen and other painkillers.

The panels could recommend placing more warnings on the drugs or banning them altogether.

Dr. Jeffrey Drazen, editor of the New England Journal of Medicine, questioned the sale of Cox-2 inhibitors when traditional pain relievers such as ibuprofen and aspirin work as well in most patients.

"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," Drazen wrote in an editorial published online.

The journal also released three new studies on Vioxx, Celebrex and Bextra on Tuesday, a month before their scheduled publication, citing possible public health implications.

One of the studies, by the National Cancer Institute, was halted when a panel of cardiovascular experts found a greater risk of heart problems among patients treated with Celebrex than those given a placebo. Patients receiving 400 mg of Celebrex twice a day were almost twice as likely to die from cardiovascular event such as heart failure or stroke than patients on 200 mg of Celebrex twice a day, and four times as likely to die from heart problems than those in a placebo group.

Dr. Randall Stafford, associate professor of medicine at Stanford University, said not all the evidence on Cox-2 inhibitors has been collected to make a clear judgment about risks. But the painkiller debacle reveals serious flaws in the nation's drug policies, he said.

Stafford last month published a study in the Archives of Internal Medicine indicating the vast majority of people given Vioxx didn't need it. He said the $5 billion annual business in prescription painkillers grew out of consumer demand and an industry that pushed that demand beyond medical necessity.

"The vast majority of people who took these drugs didn't need to and it was a waste of money," he said. "But regardless of cost, something is going wrong here. The boundaries of care were crossed."

Kaiser's Campen said patients should stick to Tylenol and other over-the-counter painkillers if they can. Last month, Kaiser announced it would no longer dispense Bextra due to concerns about increased risk of heart attack and stroke. The health plan is still prescribing Celebrex at low doses.

The Vioxx example suggests patients should not necessarily buy into the notion that a newer drug is a better drug, Stafford said. "Consumers and physicians need to be a little more conservative in their approach to new products."

The Associated Press contributed to this report. Contact Rebecca Vesely at rvesely@dailyreviewonline.com .

Source: Oakland Tribune

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