Defibrillators

Most could have been treated by older, safer, cheaper drugs.

That's why the American Medical Association, most physicians, and the Institute of Medicine - a respected nonprofit that offers advice on biomedical issues - recommend a two-year moratorium on direct-to-consumer advertising of all new drugs.That sounds like a great idea, but the Senate bill rejects it.

Instead, it would allow (but not require) the FDA commissioner to impose a moratorium only when there is clear evidence that advertising to consumers would harm patients.

This is hard to prove because new drugs lack data on widespread use.

Even worse, Kennedy's bill doesn't even require the FDA to review new drug ads for accuracy.The Institute of Medicine also calls for reducing conflicts of interest among FDA advisory panel members.

A few weeks ago, the FDA adopted some of those suggestions.

It proposed to exclude from advisory panels all doctors and scientists with financial ties of more than $50,000 in the previous 12 months to the products under review; those with a lesser financial interest could still serve on the committees, but only as nonvoting members.Having any advisers with a financial interest is like having referees who bet on their own games - an obvious conflict of inte...

Read more...