[but Glaxo telling the truth that MMR in UK is safe?]
Glaxo Knew Avandia Caused Heart Risk, Report Says (Update1)
http://www.bloomberg.com/apps/news?pid=20601087&sid=aZsrUQ9LOMwI
By Rob Waters
Feb. 20 (Bloomberg) -- Safety reviewers at the U.S. Food and Drug Administration
urged the agency to take
GlaxoSmithKline
Plc’s diabetes drug Avandia off the market in 2008 because they said it was
causing 500 additional heart attacks per month. Two U.S. senators say they want
to know why the medicine remains on pharmacy shelves.
A report released today by Senators
Max Baucus and
Charles Grassley said Glaxo knew Avandia may cause heart damage several
years before a study documented the risk and the company pressed doctors to
retract warnings about side effects. Baucus, chair of the Senate Finance
Committee, and Grassley, the committee’s ranking Republican, are pressing the
FDA for answers.
Avandia came on the market in 1999 and achieved annual revenue of $3 billion by
2006, including sales of a combination drug that includes Avandia. Sales
plummeted to $1.2 billion in 2009, two years after a
study was
published in the New England Journal of
Medicine that linked Avandia to a 43 percent increased risk of heart attack.
Two FDA officials also reviewed the drug’s safety and concluded in their 2008
report that Avandia was exposing users to higher risks for heart attacks, or
myocardial infarctions, without being any more effective than a rival drug,
Tokyo-based Takeda Pharmaceutical Co.’s Actos.
Heart Failure
“These increased risks have caused a substantial excess of acute myocardial
infarctions and heart failure that would not have occurred” had Actos been used
instead, wrote David Graham and Kate Gelperin, the two FDA officials, in the
report. Avandia “should be removed from the market.”
Glaxo, in a statement e-mailed today by
Mary Anne Rhyne, a company spokeswoman, said it rejects conclusions that
Avandia is risky for patients.
“The scientific evidence simply does not establish that Avandia increases
ischemic cardiovascular risk or causes myocardial ischemic events,” she said.
“The FDA considered all the available scientific evidence on Avandia, including
Dr. Graham’s assertions of elevated heart attack risk and demands that the
product be withdrawn,” the statement said. “Based on the scientific evidence and
a recommendation by an independent advisory committee of experts convened by the
FDA, the agency has ruled that Avandia remain available to patients for the
treatment of Type 2 diabetes.”
FDA Reviewing
Karen Riley, an FDA spokeswoman, said in an e-mail that the agency is
“reviewing the report from the senators, we take it very seriously and we will
reply quickly.”
In the 2008 report, the FDA safety officers also said that a medical trial
comparing Avandia with Actos that was being planned would be “unethical and
exploitive” because it would expose patients to unwarranted risks. That trial,
called TIDE, which was planned to involve 16,000 patients, is now under way.
Baucus, a Montana Democrat, and Grassley, an Iowa Republican, sent a
letter
Feb. 18 to FDA Commissioner
Margaret Hamburg asking what steps the agency was taking to protect patients
in the TIDE trial and demanded a response to their concerns by March 4.
Today’s Senate committee report said executives of London- based Glaxo obtained
a copy of the 2007 New England Journal study in advance of its publication from
a company consultant who also worked as a reviewer for the journal. Although
company scientists internally recognized the study’s validity and acknowledged
Avandia’s heart risks, Glaxo prepared a public relations effort to refute
suggestions that the drug triggered heart attacks, according to internal e-mails
reviewed by Senate researchers cited in the report.
Downplay Findings
“It can be argued that GSK had a duty to warn patients and the FDA of the
Company’s concerns,” wrote Baucus and Grassley in the Senate committee report.
“Instead, GlaxoSmithKline executives attempted to intimidate independent
physicians, focused on strategies to minimize or misrepresent findings that
Avandia may increase cardiovascular risk, and sought ways to downplay findings
that a competing drug might reduce cardiovascular risk.”
The risks were described in today’s New York Times in a story based on the
Senate report and other documents.
Glaxo pressed medical researchers who observed the emergence of heart and liver
problems in patients taking Avandia to stop disseminating their findings,
contacting the doctors’ superiors in several cases, according to the report.
Glaxo fell 58 cents, or 1.5 percent, to $38.26 in New York Stock Exchange
composite trading yesterday. The stock is up 18 percent in the past 12 months.
Sales of Actos, Takeda’s competing drug, were $4.4 billion for the year ended
March 2009.
To contact the reporter on this story:
Rob Waters in San Francisco at
rwaters5@bloomberg.net.
Last Updated: February 20, 2010 16:36 EST