Do we need a shakeup at the FDA, too?

A study this year has linked Vioxx to about 27,000 heart attacks and sudden cardiac deaths in the United States from the time the FDA approved the drug in 1999 through 2003. Merck is in business to help patients, and the company certainly didn't want the avalanche of lawsuits now on its doorstep. But withdrawing Vioxx four years after questions surfaced is not, as the company's ad states, "consistent with putting the interests of patients first."

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Among the questions that the [Senate Finance Committee] chairman, Sen. Charles Grassley, R-Iowa, should pursue: Why wasn't Vioxx withdrawn from the market as early as 2000, when some researchers discovered that it doubled a patient's risk of suffering a heart attack? When Merck notified the FDA in 2000 of a potential problem, why didn't the agency quickly order a trial to assess the risks?

Also, in the face of mounting evidence that Vioxx caused harm, why did the FDA approve the drug for use in children in August, only a month before it was pulled from the market? And were Merck executives reluctant to confront the problem due to the company's reliance on the drug's worldwide annual sales of $2.5 billion?

The Southern Illinoisian article

Do you need some time to think about that one before you answer?

To hear David Graham tell it during a Senate committee hearing three days ago, the United States is virtually defenseless against unsafe medicines, which he largely blames on his own employer of the past 20 years: the Food and Drug Administration.

By blaming the FDA, the scientist also thrust a simmering debate about how effectively the federal agency protects consumers and who it really serves squarely into the American conscious.

His explosive remarks -- he compared heart attacks allegedly caused by the Vioxx painkiller to "aircraft dropping from the sky" -- also now place the FDA under unprecedented pressure to overhaul how it regulates an industry that sells more than $200 billion worth of prescription drugs every year. One idea already gaining steam in Congress is to create an independent panel to oversee the agency's safety activities.

New Jersey Star-Ledger article

Everywhere we turn, when an agency is failing in its job, it seems our answer is to add more bureaucratic layers. Somehow, I don't think that's going to do what we want it to do. In this case, why don't we have an independent FDA? Isn't drug safety part of the FDA's mission? Why isn't that "independent"? Maybe that's where we need to focus.

The FDA is responsible for a delicate, high-stakes balancing act, approving drugs that provide needed relief to millions of Americans but don't cause them harm. At the same time, the agency must weigh the demands of powerful drug makers who want fast approvals so their medicines can start generating cash.

Whoa, whoa, whoa, whoa, whoa. They want to start generating cash - so they want to push through approval. Ah, the disadvantages of privatization. Who could have imagined?