No Trust in the FDA

Mark McClellan, head of the Medicare program (and brother to press secretary Scott McClellan), has a good idea that shouldn't have to be done:

Medicare head Mark McClellan, a doctor and an economist who once ran the FDA, has proposed a Medicare-based system to track the safety and effectiveness of medications.

McClellan proposes taking billing data from the prescription program, which will begin in January, and combining it with healthcare information already collected when Medicare users submit claims for hospital and doctors' care. By cross-referencing the information, a computer system could spot signs of trouble.

In other words, he wants to turn Medicare into a regulatory agency, on top of its other duties. Because the FDA is flat-out not doing its job:

Whether it's a suspected link between Viagra and rare cases of vision loss or heart attacks among arthritis patients using Vioxx, the FDA's current system of voluntary reporting picks up no more than 10% of serious drug reactions.

I don't know what you expect when you appoint pharmaceutical industry bigwigs into regulatory posts at the FDA, and transform the agency into a rubber stamp for drug companies. It seems like every week there's another revelation about some drug that was pushed to market too quickly without warning consumers of the risks. When you take regulation out of regulatory agencies, that's what you get. Clearly McClellan knows this: he ran the FDA, and he has lost all faith in it.

And it's not just Medicare that's going outside the FDA to take action:

A large private insurer, UnitedHealth Group Inc., is already creating a monitoring system similar to the one McClellan has proposed. The UnitedHealth system could cover as many as 20 million of its patients; the Medicare plan could cover as many as 43 million people, including some of the sickest and most vulnerable, whom drug companies don't usually enroll in clinical trials.

It's a failure of leadership to force private companies to override the system. And similarly, it's proof of how much our health care system is in crisis when parts of the industry feel they have to do government's job for them. Getting industry lobbyists off the FDA advisory panel is a complete no-brainer. It's common sense legislation that will never, ever pass, at least not in the current climate.

The tragedy of not only the FDA, but of the uninsured will only end when big business finally has enough of the soaring costs and leans on the lawmakers to get something done. That's already happening in a lot of circles. Universal health coverage will require the strange bedfellows of labor and management to shout in unison, "This is a right, not a privilege!"