Monday, December 12, 2005

Vioxx lessons for salt controversy

Everyone's afternoon's headlines report a mistrial in the Merck Vioxx case. A few days ago, the New York Times and the Wall Street Journal reported complaints by the New England Journal of Medicine that Merck had withheld health outcomes data on the NEJM-published Vioxx trial. NEJM editors expressed outrage that adverse cardiovascular events (heart attacks, strkes and deaths) were excluded from the Merck analysis.

The editors said they were concerned that not reporting the adverse health outcomes and selectively reporting the study results "made certain calculations and conclusions in the article incorrect." Serious charges with serious consequences. Money wasted. Lives lost. Opportunities for better health alternatives ignored. Important story.

OK, you can read all that somewhere else. What in the world does that have to do with salt?

It turns out that this same journal, these same editors, earlier published another important study where the data were incomplete and the resulting highly-heralded "calculations and conclusions in the article (were) incorrect." Two differences, however. First, the NEJM has not insisted that the authors fill in the blanks and publish the missing data. And, second, the reason may be that in the Merck Vioxx case, the allegations fingered a money-loving corporation while the research in the other case was funded by a federal agency with motives presumed as pure as those puffy white crystals falling from our winter skies.

The earlier study is the DASH-Sodium trial and the failure to voluntarily publish enough data to enable objective outside observers to verify (or "replicate," the relevant standard in the applicable federal Data Quality Act) has led the Salt Institute and the U.S. Chamber of Commerce to challenge withholding the relevant data. That case is in federal appeals court and will be heard on February 2nd.

To repeat: Money wasted. Lives lost. Opportunities for better health alternatives ignored. Important story. Whether the funding agency is a private corporation or a public agency, we need transparency to ensure that motive, means and opportunity to abuse science don't criminally sacrifice our opportunties to promote improved public health.


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