Politicizing science

Jun/07/2007 06:55 Filed in: In The News
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What a mess ! That's the only way to think of the black box warnings that were added to Avandia and Actos. The hearings yesterday resembled a circus with finger pointing and clear lines of difference between Democrats and Republicans on the data that was first reported in the NEJM. What are physicians and patients supposed to think? Is the data telling us the glass is half full or half empty? Rather than utilizing the opinions of third parties, namely physicians who have no vested interest in the product, politicians took it among themselves to interpret data mispronouncing words along the way. This is what happens when politics is mixed with science and this is going to have broad implications for patients and the pharmaceutical industry for years to come.


Data can always be manipulated and interrupted in different ways that support different conclusions, I learned that when a Manager at Lilly manipulated data to show that TV was driving sales to get bigger DTC budgets. But with scientific data there has to a way to ensure that the data is painting a picture that has a basis in reality. The FDA, when reviewing a NDA, can only recommend a drug for approval based upon the data that is submitted. They can of course ask for more data which would require more clinical studies but that could cost millions of dollars in potential sales. It seems that with Avandia, in 1999, Dr Buse a medical researcher raised some red flags about Avandia and was threatened with a potential lawsuit from GSK and a company executive calling him a "liar" and "scoundrel". GSK's response? "Dr Buse made a mistake in presenting data in a presentation he gave in 1999" This from an industry trying to install a sense of confidence with consumers and patients.

The biggest show during the hearings yesterday was when Representative Lynch of Massachusetts asked three agency people to look at Avandia's drug labels and find its warning about heart attacks and then kept repeating "have you found it yet?" . So it was a show to behold...those who want to put the FDA's feet to the fire had their chance in the national spotlight and those that called for a more balanced scientific approach were almost mute.

Instead of this show it would have been responsible to call for a review of the data from a team of independent physicians who understand medicine and diabetes. Then, based upon their findings, Congressional leaders could have acted in a responsible way that benefits patients, but this has never been about benefitting patients. It is about money, power and the spotlight and politicizing science.

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