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Commentary

Lessons from Vioxx
The Boston Globe, 12-19-05

This Globe editorial takes the FDA (and Merck) to task for allowing Vioxx on the market, and argues for a variety of new marketing restrictions on pharmaceutical companies and other FDA reforms. The Globe believes that these changes would increase patient safety without slowing the production of life-saving new medicines.

…proposals range from limiting television advertising to reverting back to the system in which the government, not the drug companies, defrayed the cost of approving a drug. It's hard to envision Congress giving up a source of revenue when the federal budget is many billions of dollars in the red. But Congress ought to ban consumer advertising, which the FDA did not allow until 1997. Prescription drugs should not be the object of a consumer marketing frenzy.
Vioxx is held in such low regard that a jury deadlocked on a verdict last week even though the patient, a man with a heart condition who later died, had only taken the drug for a month. Vioxx probably didn't cause all the heart attacks for which it will be blamed in court, but because Merck portrayed it as a safe drug for so long, many jurors are loath to give the company the benefit of the doubt.
No one wants to return to the days when FDA sluggishness delayed the approval of life-sustaining medicine, but there has to be a middle way between long delays and an approval process that makes millions of pain sufferers into unknowing guinea pigs. Tighter regulations may lessen company profits, but they will ensure that the medicines Americans take are once again considered the safest on Earth.

With all due respect, the FDA is still considered the world’s gold standard when it comes to pharmaceutical regulation. There is also no evidence that drugs are less safe than before the current system of FDA user fees (known as PDUFA) was first enacted in 1992. There is, however, plenty of evidence that PDUFA has accelerated patient access to important new medicines.

While Merck deserves serious criticism for some of its marketing practices, we shouldn’t forget that our health-care system encourages patients to splurge on expensive new drugs even if they don’t need them. If health insurance operated more like other kinds of insurance, and paid for catastrophic rather than routine costs, consumers would be more inclined to ask more questions and shop more carefully for better treatments.

As for drug advertising, broad restrictions on DTC may sound attractive in the abstract, but they inhibit the spread of information about new treatments. We shouldn’t forget that Cox-2 drugs were (and remain) an important medical innovation for patients for who didn’t get relief from traditional painkillers, or were at high risk for stomach damage. If what we want is better information about new treatments, the answer isn’t to provide less information across the board. Industry and the FDA must work together to inform consumers about drug risks and benefits rather than turning the current system upside down.



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