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Celebrex warning stirs consumer confusion

The warning about Celebrex leads to some very disturbing questions about how new drugs are approved, a job that falls to the FDA. NBC's Tom Costello reports on why the agency is in the spotlight.

For many Americans, Friday's announcement about Celebrex' link to heart problems makes what's behind the drug counter all the more frightening and confusing. In addition to Vioxx, the list of major drug recalls in recent years is getting long.

For instance, in 2001, the cholesterol-lowering drug Baycol and an injectable anesthetic known as Raplon were recalled. In 2000, the agency recalled Lotronex, a treatment for irritable bowel syndrome, as well as the heartburn drug Propulsid, and phenylpropanolamine, an ingredient common in over-the-counter medicines.

"The FDA is falling down on its job to protect people from problems with prescription drugs," says Dr. Sydney Wolfe of the advocacy group Public Citizen.

Wolfe says the Food and Drug Administration has a far too cozy relationship with the major drug companies.

A governmentinspector generalreport made public this week found that of the $187 million spent on new drug reviews, $86 million was provided by the pharmaceutical industry.

The inspector general report also found that the FDA often rushes drug reviews, and doesn't know all of the risks associated with drugs when they are approved. In fact, in a recent survey, 20 percent of FDA scientists reported feeling pressured to approve drugs, despite having reservations.

But the FDA defends its review process, which it calls sound and thorough.

"I would say that the FDA is on the job, that we're evaluating the products that are on the market," says acting FDA commissioner Lester Crawford. "We're being careful with the products before they go on the market."

And the drug industry says recalls are actually rather rare.

"The fact is, the percentage of withdrawals as a result of all the drugs that are approved is a very low 2.3 percent," says Alan Goldhammer of Pharmaceutical Research and Manufacturers of America.

But after spending $800 million, on average, to develop a new drug, companies are also eager to recoup their investment before a patent expires, which usually happens in just 12 to 17 years.