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In the Dark About Drugs

With the Bush administration and Congress preparing to hand Medicare users nearly $1 trillion over 10 years to buy prescription drugs on the private market, the least they could do is supply them with information better than the thinly documented claims in the drug companies’ TV ads.

Patients now get little help in that regard from the government, because the Food and Drug Administration doesn’t have authority to even gather the right information. For instance, the FDA can’t require researchers to publicly disclose the results of clinical drug trials.

Such problems were hashed over but not solved this week during a three-day FDA hearing, which focused on the implications of Merck’s decision to remove its painkiller Vioxx from the market last year after a study found that the drug doubled the risks of heart attacks and strokes. At the hearing, cardiologists testified to such dangers not only from Vioxx but from Pfizer’s Celebrex and Bextra, two other drugs in the same class. Nevertheless, the panel recommended Friday that Pfizer and Merck remain free to sell the painkillers, albeit with more detailed warning labels.

The panel’s deliberations showed how hard it is for medical experts to weigh drug benefits and dangers while hearing only the rosiest interpretations from drug makers. For patients, it can be all but impossible.

President Bush sold the Medicare prescription drug benefit as a way of “putting patient control and patient choice ahead of government control.” That might make sense if consumers actually could make informed drug choices.

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This is a dilemma that the Senate should pose to Lester Crawford, Bush’s nominee to head the FDA, when his confirmation hearing begins soon.

Crawford is touting the administration’s decision earlier this week to create a Drug Safety Board, a team of doctors that would bird-dog reports from physicians and hospitals of problems with FDA-approved drugs, especially newer ones. But the president didn’t set aside any new funding for the board. And doctors and hospitals aren’t even required to report drug safety issues.

The FDA also can’t compel drug companies to retest their products after problems are reported.

The FDA director, the Bush administration and Congress have it in their power to give the agency the authority it needs to acquire and make public much more information, flagged with better warnings.

Consumers may be well aware of the dangers of Vioxx by now, and willing to make their own judgments about the risk. But the patients who took it for years had no clue. Without more vigorous FDA regulation, the same will be true of the next batches of blockbuster drugs to come on the market.


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