Wednesday, November 25, 2009

They Knew

A doctor friend of mine asked why I had such a bug up my ass when it came to pharmaceutical companies. After all, I'm benefiting from a clinical study which provides me with free drugs to control my cardiac arrhythmia. Surely I can't be so ungrateful as to ignore that. I told her that I could cheerfully be so ungrateful, because after years of following the pharmaceuticals I could honestly say that their good works (research and development of life saving drugs, as in my case, at least I think so) are roundly offset by their greed when it comes to marketing. Recent history has shown that patients' well-being are happily sacrificed to sales, cheerfully and knowingly.

She scoffed, but in yesterday's Los Angeles Times I got the perfect rebuttal to her smugness. The Vioxx scandal got revisited.

Thirty studies involving more than 20,000 people demonstrated an increased risk of heart attacks and strokes linked to the drug Vioxx, which was taken off the market in 2004 after generating billions of dollars annually in sales. However, this information was not easily accessible to the public, and the Food and Drug Administration's reservations about the drug were lost in a blizzard of direct-to-consumer marketing, according to a study and commentary published today in the Archives of Internal Medicine.

The analysis showed that safety concerns about Vioxx, a nonsteroidal anti-inflammatory manufactured by Merck & Co., arose at least four years before the drug was withdrawn. Under new FDA rules, however, manufacturers are now required to disclose the results of post-market safety studies. ...

The issue is crystallized further in a commentary by Dr. Lisa M. Schwartz and colleagues of the Veterans Affairs Outcomes Group. They point out that the FDA, as the repository of post-marketing surveillance studies, is a weak opponent to the media-savvy and heavily funded pharmaceutical industry.

"The Vioxx story really highlights the difference between marketing and informing," Schwartz wrote in the commentary. "If physicians and patients had had the facts, it would have taken an alchemist, not a marketing department, to turn this lemon into gold."
[Emphasis added]

Four years. And in those four years people died of heart attacks and strokes because their doctors were not aware of the risks. Studies which would have informed patients and, probably more importantly, their physicians were hidden for four years.

I don't know which is worse: that pharmaceutical companies can hide this information or that the government helps them do so, if only by negligence or by the lack of eyes focused on the task. Theoretically at least, the new and improved FDA is halting this kind of practice. Post approval tests are supposed to be reported to the FDA and the FDA must make those reports available to the public. That, at least, is a start.

But it must be cold comfort to those who lost loved ones the last time around. It probably doesn't help that the company involved argues that these test results are questionable. It should also be cold comfort to the rest of use who know that these ghouls own a huge chunk of the table labeled "Health Care Reform."

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Blogger Woody (Tokin Librul/Rogue Scholar/ Helluvafella!) said...

This is the Johns-Manville asbestosis story again.

there is only one way to erase the larceny in the corporate soul, and that is to kill the corporation guilty of mis- or malfeasance.

Just kill 'em. Corporate death penalty.

People lose jobs? Where were the whistleblowers?

People lose money when the stock is worthless? Pay better attention to the machinations your investments facilitate.

12:10 PM  

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