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My Hero's Vioxx Study Will Be Published After All!

If you read this blog regularly, you know I've been following the exploits of my new hero Dr. David Graham, associate director in the FDA's Office of Drug Safety, who was called to the carpet recently by his FDA superiors after blowing the whistle on the agency's negligent approval of Vioxx, calling it, "the single greatest drug safety catastrophe in the history of this country or the history of this world." Now, we'll get to read what all the hubbub was about...

The FDA has finally relented, according to an announcement this afternoon, and will allow Dr. Graham to formally submit his Vioxx study to The Lancet for publication. Using data from Merck studies of heart attack and stroke risk and applying them to the number of Vioxx users over five years, Dr. Graham estimates this toxic drug may have caused between 88,000-139,000 excess cases of heart attack and stroke, according to a recent interview.

As you might expect, Merck went on the defensive, claiming "one cannot simply extrapolate data like that" to come up with an estimate of harm from Vioxx, because heart attacks and strokes are "relatively common" in the general population.

Upsetting, but not at all surprising, considering all the dollars at stake for Big Pharma. And, as you can imagine, the news affected parent company Merck on the stock market, as shares dropped almost 3 percent by the end of the day.

Yahoo News January 3, 2005

CBS MarketWatch.com January 3, 2005

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