Medicines rushed into sale blamed in deaths


WASHINGTON - As many as 100,000 Americans are killed every year by adverse drug reactions, and many of these could be avoided if companies and regulators were more careful in approving and marketing new drugs, researchers said yesterday.

New drugs have a 1-in-5 chance of causing such dangerous side effects that they will either be labeled with additional warnings years after their release or withdrawn from the market, according to a study in today's Journal of the American Medical Association.

Because the risks of new drugs are inadequately studied, doctors should wait several years before prescribing new medications for nonlife-threatening illnesses, according to the article by Dr. Karen E. Lasser, an instructor at the Harvard Medical School.

"Millions of people are exposed to unsafe drugs each year," Lasser said. "Innovative new therapies are important, but when older and safer therapies are available, new drugs should be avoided."

A drug industry group and the Food and Drug Administration criticized Lasser's report, saying that patients don't want to wait years before trying new therapies. They said the FDA already imposes a rigorous 10- to 15-year clinical trial process for new drugs.

"For many patients, delaying the prescription of new medications is a recipe for bad health," said Jackie Cottrell, spokeswoman for Pharmaceutical Research and Manufacturers of America.

During the 1980s and mid-1990s, patient advocates frequently complained that the FDA and drug companies moved too sluggishly in approving new therapies for AIDS, cancer and other diseases.

In the past few years, however, the pendulum has swung in the other direction, and the FDA has come under attack for moving too quickly and approving drugs that pose dangerous problems.

Five of 39 new drugs approved by the FDA in 1997 - including the diabetes drug Rezulin and the anti-cholesterol drug Baycol - were pulled from the market because of unexpected reactions after they were given to nearly 20 million patients, according to Lasser and her colleagues.

One of the study's co-authors, Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, described these drugs during a press conference at his office yesterday as "The Deadly Class of 1997." Wolfe said the 1997 products had a higher rate of failure than average and were linked to many deaths.

During the past quarter-century, 10 percent of the 548 new medications approved by the FDA have been withdrawn or marked with additional warnings in the Physicians' Desk Reference books used by doctors to prescribe medications. Wolfe and his co-authors estimated that a new drug today has a 20 percent chance of having these problems over 25 years.

Drugs that were approved and then withdrawn have contributed to the deaths of 1,002 people since 1993. The drug cisapride, approved in 1993 to treat acid reflux, was implicated in the deaths of 24 infants before it was pulled from the market in 2000, the article said.

Await feedback

Wolfe said that doctors should feel confident about writing prescriptions for new cancer or AIDS drugs that represent genuine breakthroughs that could save lives.

But doctors should wait until reports of problems filter back from the public, which could take years, before prescribing new drugs for less critical health problems such as obesity or anxiety. This is especially true when older medications with proven track records are available, Wolfe said.

One reason it takes so long for the negative side effects of drugs to surface is that physicians fail to report at least 90 percent of adverse reactions experienced by their patients, according to the study. Such reports are voluntary under current FDA rules.

In addition, drug companies and the FDA sometimes find problems with drugs during clinical trials but ignore them in rushing ahead with approving and marketing lucrative new products, Wolfe said.

The FDA has also failed to crack down on a rising wave of misleading TV drug ads, which often give the false impression that new drugs are better than older medications, Wolfe said.

"Drug firms may rush new drugs to market because of concerns about patent life ... and hopes for a fast 'ramp-up' in sales that will encourage investors and increase stock prices," the article said.

In a rebuttal, also published in today's Journal of the American Medical Association, a pair of FDA administrators said that the article's conclusions were questionable. Most unexpected drug problems surface within a year of their approval, the FDA officials said.

"It is incorrect to describe the introduction of unsafe drugs as frequent," wrote Drs. Robert J. Temple and Martin Himmel. "If there is a sound reason to use a recently approved drug, the physicians need not deny the patient this treatment."

Logic questioned

Curtis Meinert, director of the center for clinical trials at the Johns Hopkins School of Public Health, questioned the logic of the article's recommendations.

Meinert said that clinical trials performed before a drug's approval are intended to include only a limited number of people being studied over a limited period of time.

Unexpected side effects will always surface once the drugs are approved and doctors start monitoring their effects on a much larger and more complex general population. For this reason, Meinert said it wouldn't make sense if all doctors delayed prescribing new drugs for several years, because this would inhibit the collection of valuable data about their safety.

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