Would you take a new drug that was proven safe but not effective?

Taking a newly approved drug is NOT like a box of chocolates.

With a box of chocolates, you may not know what’s in the middle, but you know you’re going to get chocolates. With a newly approved drug, you never know what you’re going to get.

As I’ve mentioned before, the FDA often approves drugs with known safety risks. Then the agency requires post-marketing safety research. That’s not a comforting thought for consumers. But then, most people who take a new drug have no idea that safety is a secondary concern.

I recently read an article about drug company adherence to post-marketing obligations. Some companies meet their follow up deadlines. Many don’t.

The article was pretty dry. But it suddenly got interesting at the end. A former FDA commissioner offered a proposal. He believes the agency should flip the approval process. That is, they should approve drugs based on safety. Then use post-approval studies to establish drug efficacy.

It’s revolutionary!

And it’s sort of odd. Just imagine your doctor saying, “Let’s try this new drug. Nobody knows if it works. But it’s safe!”

That would be a hard sell. But at the very least, it would satisfy the old medical maxim… First, do no harm.

Sources:
“Drugmakers & Their Post-Marketing Commitments” Ed Silverman, Pharmalot, 3/5/12, pharmalot.com