http://money.cnn.com/2007/05/24/news/companies/bc.glaxo.avandia.doctor.reut/

FDA told of Glaxo's Avandia risk in 2000
President of American Diabetes Association warned the FDA about Glaxo
drug's heart risk seven years before high-profile Avandia study.
May 24 2007: 9:24 AM EDT

NEW YORK/LONDON (Reuters) -- A leading doctor voiced concerns about
the heart risks of GlaxoSmithKline Plc's diabetes drug Avandia in a
letter to the Food and Drug Administration in 2000, years before
Monday's high-profile study questioning its safety.

One year later, the FDA criticized the firm for minimizing safety
concerns, according to documents posted on the agency's Web site that
could be used by plaintiff lawyers aiming to sue Glaxo (down $0.61 to
$53.32, Charts) over its second-biggest-selling drug.

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John Buse, president-elect of the American Diabetes Association and
faculty member at the University of North Carolina in Chapel Hill,
cited "a worrisome trend in cardiovascular deaths and severe adverse
events" among patients using the drug in a letter to the agency in
March 2000.

He also accused the drugmaker of "rampant abuse of clinical trial
data."

The FDA sent Glaxo a warning letter in July 2001 after its own
monitoring, saying the company's sales representatives had played down
safety concerns and asking the company to send out a letter to doctors
warning them of the risks.

The company sent out the letters on Sept. 6, 2001, according to The
New York Times, which first reported the story.

The news comes after a pooled analysis of dozens of trials, published
in the New England Journal of Medicine this week, concluded that
Avandia increased the risk of heart attack by 43 percent and cardiac-
related death by 64 percent.

Glaxo has disagreed with the study findings. But shares in Europe's
biggest drugmaker have fallen 8 percent in the past three days on
fears for sales, profits and the risk of lawsuits that could
potentially reach billions of dollars.

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A Glaxo spokesman in London said the company and the FDA had
consistently monitored for adverse events since Avandia's approval in
1999.

"In doing so, the product labeling for Avandia has been updated
several times to reflect new data, including with new cardiovascular
safety information," he added.

"The totality of the data show that Avandia has a comparable
cardiovascular profile to other oral anti-diabetic treatments."

U.S. and European regulators have given a measured response to the new
analysis, advising patients to talk to their doctors but not taking
any immediate action to restrict Avandia use. The FDA will hold an
expert advisory meeting at a later date.

Plaintiff lawyers, however, are expected to latch onto the warnings
from years ago as they seek to build a case for bringing product
liability lawsuits against Glaxo.

Lawyers said Wednesday they were already fielding calls from Avandia
users, with one predicting lawsuits could run into tens of billions of
dollars.

Avandia sales were £1.6 billion ($3.16 billion) and accounted for 7
percent of group revenues - and significantly more of profits - in
2006.

Glaxo Chief Executive Jean-Pierre Garnier told reporters Wednesday it
was too early to say if Avandia would be the subject of lawsuits and
he was confident its safety would be vindicated.

He said there had been an "over-reaction" to one statistical analysis,
which could not be looked at in isolation.

The New York Times reported Buse as saying that his opinion of Avandia
had not changed over the years, but that regulators should not rush to
judgment and instead await the results of a large study now being
conducted by Glaxo.

Industry analysts expect results from the so-called RECORD clinical
trial, designed specifically to study cardiovascular outcomes in
patients on Avandia, in 2009.

The $8 billion diabetes drug market is dominated by companies
including Merck (Charts, Fortune 500), Pfizer (Charts, Fortune 500),
Sanofi-Aventis (Charts), Eli Lilly & Co (Charts, Fortune 500). and
Amylin Pharmaceuticals (Charts).