but the pills the FDA approves don't do anything at all. Schwartz and Woloshin have a kvetch, that a lot of information the FDA has about the drugs it approves don't make it onto the "label" -- actually a many-page document which is supposed to discuss the risks, benefits, indications and counterindications. The drug companies write these labels themselves, and the FDA just approves them. So, no big surprise, they tend to overstate the benefits and underplay the downside.
However, I take a further lesson from the cases they discuss, which is that some of these drugs never should have been approved in the first place, because they don't actually work. And not surprisingly, these drugs that don't actually work are often among the most heavily marketed and the biggest sellers.
Take Lunesta. If you own a television, you have been exposed to countless visions of formerly sleepless, cranky people passing instantly into sweet oblivion and awaking as though dipped in the fountain of youth. But as it turns out:
Lunesta sales reached almost $800 million last year. Clinicians who are interested in the drug's efficacy cannot find efficacy information in the label: it states only that Lunesta is superior to placebo . . . The FDA's medical review provides efficacy data, albeit not until page 306 of the 403-page document. In the longest, largest phase 3 trial, patients in the Lunesta group reported falling asleep an average of 15 minutes faster and sleeping an average of 37 minutes longer than those in the placebo group. However, on average, Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvement in next-day alertness or functioning.
Oh. So what are we spending the $800 million for?
Well, it's not the FDA's job to decide whether a drug is actually worth anything. It just has to be superior to placebo, not necessarily in any clinically significant way. And while risk of serious adverse effects could make a drug non-approvable in principle, there aren't any clear criteria for deciding when risks outweigh benefits to the extent that a drug should not be approved. Indeed, risks often emerge after approval but seldom lead to withdrawal.
But it has to be somebody's job to make the judgment that it just doesn't make sense to prescribe this drug. That's the agency we don't have here in the U.S. - and no, it's not in any of the Senate bills.