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Medicare's Bright Idea

June 13, 2005

Somehow it always comes as a surprise when a huge government bureaucracy proposes something sensible, efficient and geared to the public good. This time the happy shock comes from Medicare.

Smart people at the agency have put forth the idea of using its massive databank of patient information to spot potential problems with drugs more quickly. So why is the Food and Drug Administration, which oversees drug approval and safety, dragging its feet?

There are medications that pass experimental trials with flying colors and then prove problematic, in large part because a drug trial involves limited numbers of people over a limited time. Medicare, which provides healthcare for millions of elderly patients, proposes to create an early warning system by having a computer match health problems that show up in doctor bills with drugs billed for the same person under the new prescription drug benefit that starts in January. The information will be there; it's just a matter of using it.

As Times writer Ricardo Alonso-Zaldivar reported, this could shave years off the time it takes to match popular drugs with previously unknown side effects -- such as the possible link between Viagra and occasional cases of vision loss, or the risk of heart attack from the arthritis drug Vioxx, which has been pulled from the market.

The idea should be taken beyond Medicare to include Medicaid (Medi-Cal in California), which covers a broader age spectrum, including children. Adding private health insurers' data would also increase its value. Further interpretation of the data also could assess which drugs are most cost-effective, comparing new drugs, for instance, to old ones long on the market.

The FDA hasn't said no to the idea. It hasn't said yes. It hasn't given a reason for its slow response. Senators from both parties are considering legislation to get this innovative and practical idea going, and if the FDA doesn't move soon, they should.

Of course, the pharmaceutical industry is likely to be unhappy with results of such a system, especially if more expensive new drugs are found to be no more helpful than cheaper ones.

That's not the public's concern and it shouldn't be the FDA's. Quite possibly, the FDA is just engaging in old-fashioned inefficiency and lack of resolve. Now that's the kind of bureaucracy the U.S. public is sadly accustomed to seeing.

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