Diabetes Drug Maker Hid Test Data on Risks, Files Indicate

[cal04]

Source: NY Times

In the fall of 1999, the drug giant SmithKline Beecham secretly began a study to find out if its diabetes medicine, Avandia, was safer for the heart than a competing pill, Actos, made by Takeda.

Avandia’s success was crucial to SmithKline, whose labs were otherwise all but barren of new products. But the study’s results, completed that same year, were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart.

But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.

“This was done for the U.S. business, way under the radar,” Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results that was obtained by The Times. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK,” the corporate successor to SmithKline.

Read more: http://www.nytimes.com/2010/07/13/health/policy/13avandia.html?hp

[Angry Dragon]

1. How many deaths are these people responsible for??

When is congress and the government going to wake up and start doing their jobs that they spent so much money to get??

It seems that once these idiots get elected they figure that their work is done and they can just sit on their fat asses and just collect money to fill their pockets.

[grasswire]

2. how is this not some kind of manslaughter? just like Toyota

This just makes me sick.

[spinbaby]

3. Free market doncha know

Just deregulate them some more and the miraculous properties of the free market will fix everything.


:sarcasm:

[activa8tr]

7. And drop their taxes, while we're at it.

[EXneoCON]

4. F*ck SKB...

[cal04]

5. GlaxoSmithKline Hid Negative Avandia Data: Lawmakers

http://abcnews.go.com/Health/Diabetes/glaxosmithkline-hid-avandia-risks-senate-committee/story?id=11152726

GlaxoSmithKline, maker of rosiglitazone (Avandia), hid negative trial results on the controversial diabetes drug more than a decade ago, according to a report released by the Senate Finance Committee.

Rosiglitazone was approved by the U.S. Food and Drug Administration in 1999 to treat type 2 diabetes. But "as far back as 2000, internal e-mails show that GSK executives sought to downplay scientific findings, which raised questions about the safety ," the committee wrote, citing an internal memo about a trial comparing rosiglitazone to pioglitazone (Actos) that found rosiglitazone presented a "worse lipid profile" than its competitor.

(snip)
A joint advisory panel of outside experts is meeting Tuesday and Wednesday to discuss the future of rosiglitazone. The panel will vote Wednesday on whether to pull the drug from the market. Although several FDA reviewers support yanking the drug, others do not, and the advisory committee will hear conflicting views on the safety and efficacy of the drug over the next two days.



Baucus, Grassley Find Company Failed to Promptly Alert FDA about Drug Risks
http://finance.senate.gov/newsroom/chairman/release/?id=bcf5aef6-9bc5-45ca-9cab-aadf5df135fa

[activa8tr]

6. Why is the government trying to interfere with free enterprise? Lying is an American

tradition! How "un-American" of the government to investigate!

[Vidar]

8. I had personal experience with Avandia. I was on it for over six years & when

the Medicare part D fiasco came along, my monthly bill for Avandia went up to $305, something I could clearly not afford. Expecting to die, I went off it cold turkey nonetheless--best thing that could have happened to me. Aside from from heart failure, the other major adverse side effect of Avandia is weight gain, clearly not in a diabetic's best interest. Within a year, I lost 120 lbs. Increased exercise also helped, but it was mainly due to going off Avandia.

Now, my wonderful doctor has me on a much safer drug, which is on Walmart's $3/month list. Despite what I think of Walmart's corporate policies, I currently enjoy the 10 mile bike ride to Walmart & far better health. I wish the very worst to the manufacturers of Avandia