A new FDA drug safety monitoring system is busted before it gets started

All Along the Watchtower

FDA officials have figured out how to make good use of America’s elderly: Turn them into drug trial guinea pigs.

How slow can you go?

Having the FDA plan your safety is like having Mike Tyson plan your ballet recital. The difference is that Mike isn’t expected to oversee ballet productions, but FDA officials ARE supposed to be sentinels – standing watch to block unsafe drugs from entering the marketplace.

Recently those officials announced that they have a new plan to track drug safety. But easy now – don’t get all excited and start thinking that we’ll be seeing tough new oversight of pre-approval drug trials. No, the FDA has laid out a new plan called the Sentinel Initiative, which will eventually produce the Sentinel System, described as a “national, integrated, electronic system for monitoring medical product safety.”

The preparation for the Initiative that will lead to this new System has been in the works for about three years. In other words, this project is moving along at the speed of government.

Here’s the plan: FDA officials will use data collected from Medicare claims to track and evaluate the dangerous side effects of drugs the agency has already approved. Put another way: Instead of raising the bar and requiring that pre-approval drug trials demonstrate rigorous new standards to reveal potential dangers, the FDA has decided to watch for safety problems the drugs may cause among Medicare patients.

So if you take prescription drugs that are paid for in part by Medicare – congratulations! You’ve just been enrolled in a drug safety trial!

Wellnot quite yet. According to a New York Times report, researchers (who praised the initiative) admitted, “its fruits would take years to realize.”

They break it, you buy it

Am I being too hard on the FDA? After all, maybe this isn’t the best plan, but at least they’ve come up with SOME kind of monitoring method.

Wellbesides the fact that it’s POST-active, the key problem with the Sentinel System is that it’s already broken. In fact, it’s broken in three places.

ONE: The Times notes that Medicare only records information when a doctor or a hospital makes a request for payment. In other words: There’s plenty of room for safety problems to fall through the cracks.

TWO: Under the current system, Medicare drug benefits are implemented through a multitude of private plans, making data collection just that much more difficult for an agency that’s already facing budget and staff cuts.

THREE: Records show that Medicare beneficiaries are prescribed a mind-boggling average of nearly 30 drugs each year, according to the Times. So good luck to any doctor who tries to figure out which individual drug (or combination of drugs) is causing a specific side effect.

One, two, three If this were baseball, the Sentinel Initiative would be taking that long walk back to the dugout.

“FDA’s Sentinel Initiative” fda.gov
“F.D.A. to Expand Scrutiny of Risks From Drugs After They’re Approved for Sale” Gardiner Harris, New York Times, 5/23/08, nytimes.com