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Rx for Drug Safety

Drug approval process thorough and painstaking, federal officials say

TUESDAY, May 28, 2002 (HealthDayNews) -- For many people, prescription drugs aren't only safe to use, they can be lifesaving treatments.

And despite rare recalls -- such as last year's removal of the cholesterol-lowering medication Baycol -- experts say there's no cause for concern.

The key reason: The rigorous testing that takes place before a drug can gain approval by the U.S. Food and Drug Administration (FDA).

"There is a very complex, very good safety system in place, and it's getting stronger every day," says Dr. John Gallin, director of the National Institutes of Health Clinical Center, the government agency responsible for funding many of the clinical trials conducted in the United States.

The testing of a new drug starts with a clinical trial -- a round of testing that usually begins on a small number of people.

But before a clinical trial can begin, it must be subjected to a "peer scientific review" -- a close scrutiny of the purpose of the trial -- by experts in the field. What they're looking for is whether the drug will accomplish what's it's designed to do. For example, will a proposed blood pressure medication safely and effectively work better than other similar drugs on the market?

If the study passes that first round of scrutiny, it's on to an internal review board, or IRB.

"This board consists of an equal balance of scientists, doctors and lay people who also look at the study for the risk-benefit ratio," says Dr. Gregory W. Siskind, associate dean of research compliance at Weill Cornell Medical College in New York City.

In essence, an IRB decides if the testing is safe, and if there is likely to be an appropriate potential benefit, Siskind says.

At either the request of an IRB, or sometimes before it reaches one, the data will also be reviewed at still another checkpoint -- by a data safety monitoring board, DSMB.

"Their job is to advise the IRB if a study is well-designed, and if the investigators are likely to answer the question their study proposes to answer," Gallin says.

A DSMB can also continue to monitor a clinical trial at whatever interval is suggested by the IRB, looking for such things as early evidence of toxicity, in which case the trial is canceled, Gallin says.

In addition, says Siskind, if the drug being tested is new, the FDA requires that the drug's manufacturer apply for an "investigational new drug agreement," necessary before a clinical trial can even be considered.

Once all the review requirements are met, a clinical trial begins. It often starts with a small group of people on whom the drug is tested for safety. It then moves on to larger numbers of people -- up to 4,000 -- testing for both safety and efficacy.

Once the clinical trials are completed, a FDA division known as the Center for Drug Evaluation and Research takes over. Its job is to analyze all trial data, along with any information provided by the drug manufacturer, to determine the benefit-to-risk ratio of the new medication.

If the benefits outweigh the risks, the drug generally is approved. The entire process, from testing to approval, can take several years or more.

In addition, the FDA has a post-approval surveillance system that allows for continuous monitoring of a drug's performance. Doctors are alerted at the first sign of a potential problem not seen in clinical trials.

With all these safeguards in place, unsafe drugs almost never make it to the market. In fact, less than 3 percent of drugs approved by the FDA each year are removed from the market for safety concerns, says Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research.

Currently, the FDA is the watchdog agency for more than 10,000 drugs it has approved. Woodcock says the withdrawal rate has remained essentially consistent over the past two decades, with between 2.7 and 2.8 percent of approved drugs removed for safety concerns.

What To Do: For more on the FDA's drug approval process, visit the Center for Drug Evaluation and Research. You can also find which new medications are under clinical trial right now by visiting The National Institutes of Health.

SOURCES: John Gallin, M.D., director, National Institutes of Health Clinical Center, and associate director, clinical research, National Institutes of Health, Bethesda, Md.; Gregory W. Siskind, M.D., associate dean, research compliance, Weill Cornell Medical College, New York City; prepared statements by Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, Washington, D.C.
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