Diabetes Drug Maker Hid Test Data on Heart Risks....New York Times.

[Stuart G]

Diabetes Drug Maker Hid Test Data on Risks, Files Indicate
By GARDINER HARRIS
Published: July 12, 2010

http://www.nytimes.com/2010/07/13/health/policy/13avandia.html?_r=1&hp

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.

The heart risks from Avandia first became public in May 2007, with a study from a cardiologist at the Cleveland Clinic who used data the company was forced by a lawsuit to post on its own Web site. In the ensuing months, GlaxoSmithKline officials conceded that they had known of the drug’s potential heart attack risks since at least 2005.

But the latest documents demonstrate that the company had data hinting at Avandia’s extensive heart problems almost as soon as the drug was introduced in 1999, and sought intensively to keep those risks from becoming public. In one document, the company sought to quantify the lost sales that would result if Avandia’s cardiovascular safety risk “intensifies.” The cost: $600 million from 2002 to 2004 alone, the document stated.

Mary Anne Rhyne, a GlaxoSmithKline spokeswoman, said that the company had not provided the results of its study because they “did not contribute any significant new information.”

[SheilaT]

1. We hear these kinds of things

all too often.

Someone needs to do a study just seeing if in general people who take medications are healthier/better off than those who don't.

[FBI_Un_Sub]

2. She was right

"Mary Anne Rhyne, a GlaxoSmithKline spokeswoman, said that the company had not provided the results of its study because they “did not contribute any significant new information.”

Hmmm. My Dr knew about the results early on and strongly recommended against Avandia.