NEW YORK (AP) - 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.
The agency ordered a warning to be included on Avandia's label
in 2007, saying that it might increase the risk of heart attacks,
though the data on those risk was inconclusive.
Soon afterwards Sen. Grassley, one of the FDA's toughest critics
in Congress, disclosed that the agency's internal safety experts
came within one vote of recommending a withdrawal of Avandia.
The Senate report suggests sharp disagreements remain at the FDA
over how to handle Avandia's risks.
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
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.
"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 Takeda
Pharmaceutical's diabetes drug Actos, and found that Avandia has an
increased risk of heart attack and heart failure. Actos is
co-promoted by Pfizer Inc.
At FDA's request, Glaxo agreed in 2007 to conduct a six-year
study between its drug and Actos, to give a definitive picture of
Avandia's safety. The study, which will involve 16,000
participants, is still enrolling patients.
But FDA researchers quoted in the report called the study
"unethical and exploitative," since patients will continue taking
Avandia, a drug with known risks, over Actos, which has not shown
any links to heart prblems.
FDA spokesman George Strait said the FDA is reviewing new data
on Avandia and will present those findings to an advisory committee
"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.
Avandia was Glaxo's third best-selling drug in 2006 with revenue
of $2.2 billion. But the safety concerns disclosed the following
year slashed revenue to $1.2 billion by the end of 2008.
Avandia is intended to control blood sugar by increasing the
body's sensitivity to insulin, a protein critical to digesting
Insulin-regulating treatments have long been presumed to lessen
the heart risks already associated with diabetes, which is linked
On the Net:
Finance Committee letter and report:
Food and Drug Administration: www.fda.gov
AP Business Writer Matthew Perrone contributed to this report.
(Copyright 2010 by The Associated Press. All Rights Reserved.)