Using Medicare To Track Drug Safety?

During his testimony late last year, FDA whistleblower and drug safety reviewer David Graham (a personal hero of mine) warned Congress federal drug regulators were virtually incapable of protecting America from unsafe drugs. Medicare chairman Mark McClellan has proposed a creative and very rational solution for getting a better handle on drug safety: A Medicare-based system that tracks safety and effectiveness.

That would certainly be a welcome safety net considering the FDA now approves drugs based on clinical trials of a few thousand patients (and some drugs were even approved after a fast-track process that showed they didn't help patients live any longer).

The proposal: Combining billing data from Medicare's prescription program, which will begin in January, with healthcare information already collected when Medicare users submit claims for hospital and doctors' care. By cross-referencing that information, a computer system could spot signs of trouble. The data pool would be so large, drug problems would be much easier to detect than they are now, McClellan says.

Although the plan sounds reasonable and sensible -- it could track as much as 43 million people, most of whom are sick, vulnerable and have never participated in a clinical trial -- it's not surprising to learn the FDA is lukewarm and noncommittal at best about McClellan's proposal, first discussed during a recent drug safety advisory committee meeting on ways to improve monitoring and reporting.

Even though no one at the agency has publicly considered the plan, one health care insurer -- UnitedHealth Group -- is already creating a monitoring system similar to the one McClellan has proposed to monitor as many as 20 million of its patients and is set to launch it in August.

The FDA's continuing intransigence has prompted Congress to get involved. Sens. Charles E. Grassley (R-Iowa) and Max Baucus (D-Mont.) are considering legislation to authorize Medicare to set up the monitoring system. I can only hope the drug lobby -- with its deep pockets -- won't be able to buy themselves out of this one.

Los Angeles Times June 5, 2005

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