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Senior Citizen Health & Medicine
Sen. Grassley Says FDA Knew Dangers of Avandia,
Wants Faster Action
Ranking Senate Finance Committee members says there
should already be ‘black box’ warning
 May 25, 2007 – Senator Chuck Grassley (R-Iowa)
spoke on the floor of the Senate yesterday calling for major changes in
the way the Food and Drug Administration does business. After his review
of FDA records on the diabetes drug Avandia, which was found by an
independent researcher to increase the risk of heart attack, Grassley
says the FDA should have already issued a ‘black box’ warning and he
recommends that in the future the FDA office responsible for post
marketing safety needs to have the ability to warn Americans of
dangerous drugs. He says there could be about 20 or more unnecessary
heart attacks a day caused by Avandia.
Grassley, ranking Republican on the committee, and
Chairman Max Baucus (D-Mont.), responded immediately when the damaging
Avandia research was released online by the New England Journal of
Medicine (See sidebar links).
Following are the comments by Grassley made
yesterday:
“Over the last few days there have been countless
articles about the popular diabetes drug Avandia. For me, some of the
most important questions that need to be answered here are what did FDA
know, when did it know it, and what did it do with the information.
“Since The New England Journal of Medicine first
reported on a new study by Cleveland Clinic Cardiologist Dr. Steven
Nissen, my investigative staff has continued to gather information about
both FDA and the drug maker.
“We’re hearing a lot about what's called the
“RECORD” study, which was requested by the Europeans. There was talk at
the FDA, before this week's stories started appearing, that the agency
wanted to wait for that study to be completed before it made a decision
about whether or not to say anything about Avandia and the possible
increased risk in heart attacks. Believe it or not, FDA officials have
confirmed for my investigators this week that the “RECORD” study is not
expected to be completed for two more years, until the summer of 2009.
That's a long time from now when you have millions of American's taking
this drug.
“Second, there is something I'd like to clarify.
We've been reading this week that the FDA was not in a position to tell
the American people about its concerns with Avandia because it needed
"conclusive" information. That doesn't make sense to me.
“The preliminary findings of the FDA's ongoing
"meta-analysis" of the Avandia clinical trials have been consistent with
Dr. Nissen's findings of an increased heart attack risk, as well as the
drug maker's findings.
“It goes like this: the drug maker sees a 31
percent increased risk of a heart attack; the FDA sees a 40 percent
increased risk for heart attacks; and Dr. Nissen sees a 43 percent
increased risk for heart attacks. Those numbers seem like a high enough
threshold to me for the FDA to warn the American people of the
possibility of a problem.
“Third, several months ago, the Division of Drug
Risk Evaluation, which sits within the Office of Surveillance and
Epidemiology, recommended a “boxed” warning for Avandia. Why? Because it
was believed that Avandia increased the risk of heart attacks. To date
FDA has not acted on upon this recommendation.
“In a statement I released on Tuesday, I also
pointed out that about a year ago some FDA scientists recommended a
black box warning for congestive heart failure. There is still no black
box warning for congestive heart failure, and I understand that happened
because the office that put Avandia on the market in the first place
wanted to look into it further.
“America is still waiting for a decision.
“It was also reported to me that the incidence of
heart attacks with Avandia could be about 60,000 to100,000 from 1999 to
2006. That is a lot. Just doing the math and using conservative numbers,
that means about 20 or more unnecessary heart attacks a day.
“At a minimum, I think that the office responsible
for post marketing safety needs to have the ability to warn Americans
when it thinks it needs to do so.
“If not, we have what we have here today, delays in
telling the American people about a possible serious safety problem.
It's not right, and I am going to keep working to change things once and
for all. The FDA legislation passed by the Senate two weeks ago dropped
the ball on this important reform.
“The Avandia case sets it up for the House of
Representatives to give real clout to the FDA office that monitors and
assesses drugs after they're on the market and taken by millions of
people. If the Office of New Drugs continues to call all the shots, like
it does today, then it's more status quo and less public safety from the
FDA. Both the evidence and the experts underscore the need for real
reform here.
“One opportunity to improve upon post-marketing
drug safety stems from the Access to Medicare Data Act that I filed
today with Senator Baucus. This bill is based on S.3897, the Medicare
Data Access and Research Act, which Senator Baucus and I introduced in
the 109th Congress. The purpose of the bill is to provide federal health
agencies and outside researchers more sources of data for examining
adverse events so that serious safety questions are identified promptly
and timely action can be taken to protect American consumers.
Sen. Grassley, on Tuesday, made the statement
below about his review of the actions of the Food and Drug
Administration with Avandia:
“Current and former FDA employees have confirmed
for my staff investigators that when it came to concerns about
congestive heart failure with Avandia, there was a clear difference of
opinion between the office that approves drugs and the office that
monitors the drugs once they’re on the market.
“The office that’s responsible for surveillance of
drugs recommended a black-box warning, which provides the highest level,
strongest warning to doctors and their patients.
“The FDA didn’t take that advice. Instead the
warning about congestive heart failure risks with this drug is currently
buried on line 351 of the label.
“I’ve also learned that at least one of the FDA’s
experts on diabetes, who was described as a ‘reviewer with a
conscience,’ was removed from involvement with Avandia. This raises
questions that I intend to keep asking until there are answers.”
Additional information from his office:
“Sen. Grassley has twice introduced comprehensive
FDA reform legislation (S.468 in the 110th Congress and S.930 in the
109th Congress) that would give the Office of Surveillance and
Epidemiology – the office that monitors drugs once they’re on the market
– independent authority to review FDA-approved drugs and determine the
need to provide information about newly identified risks associated with
these pharmaceuticals.
“He introduced a modified version of his
legislation to strengthen the post-market review function within the FDA
by giving the Office of Surveillance and Epidemiology shared authority
with the Office of New Drugs on these matters when the Senate considered
and approved the FDA Revitalization Act (S.1082) earlier this month.
“Sen. Grassley’s amendment was defeated by a single
vote. As a result, the Senate version of the FDA proposal that is making
its way through the legislative process gives the FDA more authority and
power, but it doesn’t specify that it’s for the Office of Surveillance
and Epidemiology.
“Unless the FDA Commissioner decides to change the
way the FDA operates, the Office of New Drugs will continue to be the
office that decides when label changes need to be made for new warnings
and whether and what studies to require from drug companies after a drug
is approved. Under the Senate bill, the Office of Surveillance and
Epidemiology will be kept at its current status as a consultant to the
Office of New Drugs.”
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