Senate Report: Avandia Maker Knew of Cardiac Risks

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The Associated Press

Senate Report: Avandia Maker Knew of Cardiac Risks

by
Barbara Ortutay

A GlaxoSmithKline logo is seen outside one of its buildings in west London, in this February 6, 2008 file photo. REUTERS/Toby Melville

NEW YORK - A Senate report said Saturday that drug maker
GlaxoSmithKline knew of possible heart attack risks tied to Avandia,
its diabetes medication, years before such evidence became public.

Sen. Max Baucus,
chairman of the Senate Finance Committee, and Chuck Grassley, the
committee's ranking Republican, released the report, which follows a
two-year inquiry, on Saturday. They are also asking the U.S. Food and Drug Administration
why it allowed a clinical trial of Avandia to continue even after the
agency estimated that the drug caused 83,000 heart attacks between 1999
and 2007.

In a letter to FDA Commissioner Margaret Hamburg that
was also released Saturday, the senators said the committee's report
was based on researchers' studies of Avandia, internal GlaxoSmithKline
documents and FDA documents. They said committee investigators had
interviewed GlaxoSmithKline and agency employees as well as what it
called anonymous whistleblowers.

Based on its knowledge of the
heart attack risks, GlaxoSmithKline "had a duty to sufficiently warn
patients and the FDA of its concerns in a timely manner," the report
said.

Instead, the company tried to downplay findings that the
drug could increase cardiovascular risks while also working to downplay
findings that a rival medication might reduce such risks, it said.

GlaxoSmithKline
said in a statement the drug is safe. It said the committee report took
data out of context from analyses of Avandia.

In May 2007, the
New England Journal of Medicine published an analysis of dozens of
studies on nearly 28,000 people who had taken Avandia. The journal said
there was a 43 percent higher risk of heart attack for those taking
Avandia compared to people taking other diabetes drugs or no diabetes
medication. The findings raised concerns because two-thirds of the
people with Type 2 diabetes, the most common form, die of heart
problems.

Later that year, the FDA ordered a warning to be
included on Avandia's label warning that it might increase the risk of
heart attacks. But the label also says data on the risks are
inconclusive.

"Contrary to the assertions in the report, and
consistent with the FDA-approved labeling, the scientific evidence
simply does not establish that Avandia increases cardiovascular
ischemic risk or causes myocardial ischemic events," GlaxoSmithKline
said.

In their letter to Hamburg, the senators said the documents
the committee reviewed included an analysis conducted by two safety
officials at the agency. The analysis compared Avandia to Pfizer Inc.'s
Actos diabetes drug, and found that Avandia has an increased risk of
heart attack and heart failure.

The letter also quoted the
researchers as saying that said the study itself was dangerous, as it
meant patients continued to take the drug.

FDA spokesman George Strait said the FDA is reviewing new data on Avandia and will present those findings to an advisory committee this summer.

"Meanwhile,
Commissioner Hamburg is reaching out to ensure that she has a complete
understanding and awareness of all of the data and issues concerning
this drug," Strait said.

Finance Committee letter and report: http://finance.senate.gov/press/Gpress/2010/prg022010b.pdf

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