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August 30, 2007

More Transparency Needed in Government Studies

In a Wall Street Journal op-ed today, Dr. Scott Gottlieb criticizes several recent government studies that purport to show that older, generic drugs are just as good as their newer, and more expensive, competitors:

The $725 million Women's Health Initiative was rooted in some good intentions, but was set against a backdrop of fiscal and political bickering over the efficacy of the costly drugs. Unfortunately, this influenced not only how the findings were computed but also how they were received. As this newspaper's Tara Parker-Pope first reported in July, when initial results confirmed populist refrains that the drugs were being overused, the data were rushed to print with a carefully orchestrated PR blitz, while subsequent efforts to test the initial conclusions were sluggish.

Federal researchers refused to share bottom-line results, even with outside academics or the companies that manufactured the drugs. This allowed them to closely guard their monopoly over the original data and therefore the prerogative to publish follow-up findings. It's a sure bet if the data had been more widely shared, important analyses that debunked some of the initial conclusions would have come to light much sooner.

And unless something is done to make sure that data is shared, there will be many similarly flawed government studies to test the efficacy of drug treatments, especially the politically popular "comparative" studies that pit expensive new medicines against older, cheaper alternatives with the aim of cutting health-care spending.

The government's temptation to push cheap generics ahead of branded drugs is nearly irresistable, since there are many other competing interest groups (doctors, hospitals, et al) that stand to benefit from reallocating funds from prescription drugs to other services.

Still, some comparative effectiveness studies are undoubtedly worth doing and can help improve patient care, but we agree with Gottlieb that government studies have to be very carefully designed and should offer the same data transparency that policymakers routinely demand from industry funded studies.

Posted by Paul Howard at August 30, 2007 09:41 AM

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