Doctors Ponder FDA Drug Controversy

Nov. 22, 2004 — -- Startling testimony by an FDA drug safety reviewer about five popular medications has the medical world buzzing about how tightly the agency should be regulating new medications.

In his Senate testimony last Thursday, FDA reviewer Dr. David Graham may have managed to scare thousands of unknowing patients as well.

Graham warned that Americans are "virtually defenseless" if other medications are deemed unsafe after having been approved by the Food and Drug Administration. He named five commonly prescribed medications already approved by the agency that he believes warrant re-evaluation.

These medications -- Accutane, an acne medication; Meridia, a weight-loss agent; Bextra, a pain reliever in the same class as Vioxx; Crestor, an anti-cholesterol medication; and Serevent, an asthma drug -- already passed rigorous clinical testing before being approved for use by the FDA.

Debating the FDA's Role

Some in the medical world believe the agency needs to use the recent controversy over Vioxx, the arthritis drug that was found to increase risk of heart disease and was subsequently withdrawn by Merck, as a sign that it needs to become even more aggressive in the way it evaluates drug safety.

"With Vioxx in particular we've had a disaster of substantial proportions, and we still have important questions to answer on drugs that are still in the pipeline," said Thomas Moore, a health policy analyst for the George Washington University's Center for Health Services and Policy in Washington.

"The FDA absolutely must become strict with the way it handles medication safety," he said.

But others argue that there is more harm in tightening regulations than meets the eye.

"The far greater danger is if the Vioxx episode results in [the] FDA slowing down the approval of new therapies," said Sam Kazman, general counsel for the Competitive Enterprise Institute in Washington, D.C.

"The FDA is inherently subject to deadly over-caution, which is an overriding concern about the possibility of approving a drug that later turns out to have adverse side effects. The inevitable result is that it overlooks the risks of delaying or disapproving a badly needed drug," he said.

'They Are Experimenting on Us'

Physicians are also concerned with how patients will react to discovering that a medication they have used for years without concern is now considered a threat by one of the FDA's top officials.

Dr. Anthony Fiorillo, an internist at the University of Pittsburgh, says that he has already started to receive phone calls from worried patients. "They are concerned in general," he said. "All this week I have heard some say, 'They are experimenting on us.' "

Physicians who routinely prescribe the medications singled out by Graham on Thursday have mixed opinions on how they will advise patients.

Many who offer patients Bextra, a member of the same drug class as Vioxx with a similar side-effect profile, and Crestor, which had previously been cited for increasing the risk of muscle damage and kidney failure, admit they will now think twice about prescribing them.

"I would advise most patients on Bextra to discontinue it," said Dr. John Clough, a rheumatologist at the Cleveland Clinic. "The possibility of problems exists, so I would look for an alternative medication."

Dr. Albert Levy, an internist at the Mount Sinai Hospital in New York, had voiced concerns with Crestor when studies began to raise concern about side effects this past June. "I will definitely change my prescribing Crestor, as other statins are on the market with less possible side effects."

However, in the case of Meridia, Serevent and Accutane, many doctors feel that the benefits of giving the medications far outweigh their potential risks. Possible side effects of these three medications include stroke, heart problems and psychiatric disorders including suicidal thoughts, respectively.

But many physicians believe if the drug ultimately improves a patient's quality of life, its use outweighs any minor side effects.

"Just about any drug has some risks," said Dr. Marvin Bittner, an internist at Creighton University in Omaha, Neb. "The appropriate use of drugs is to use them when the benefits outweigh the risks. Sometimes that means taking a drug that, unfortunately, will cause harm in a particular patient."

But for some, that is not a risk worth taking.

"There's no way doctors can do an accurate risk-benefit analysis without strict drug testing," said Moore. "So it makes no sense to give them power to make those sorts of decisions."