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Senior Citizen Health & Medicine
FDA Wants Black Box Warnings for Diabetes
Medications Avandia, Actos
Rep. Henry Waxman says FDA dropped the ball with
Avandia
June 7, 2007 - The Food and Drug Administration has
requested a black box warning for the labels of the type 2 diabetes
medications Avandia, manufactured by
GlaxoSmithKline,
and Actos, manufactured by
Takeda
Pharmaceuticals, because of increased risk for congestive
heart failure associated with the medications, agency Commissioner
Andrew von Eschenbach announced on Wednesday at a
House Oversight and
Government Reform Committee hearing, the
New York Times
reports.
FDA issued the request on May 23, according to von
Eschenbach. FDA previously had not made the request public (Harris,
New
York Times, 6/7).
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Health & Medicine |
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FDA last month issued a public safety warning about
Avandia in response to a study published on the
New
England Journal of Medicine Web site. For the study,
Steven Nissen and Kathy Wolski of the
Cleveland Clinic
analyzed the results of 42 previous studies of Avandia that involved
27,843 participants.
The study found that 86 participants who took
Avandia experienced a heart attack, compared with 72 of those who did
not take the medication, a statistically significant 43% increased risk.
In addition, the study also found that 39 participants who took Avandia
died from cardiovascular events, compared with 22 of those who did not
take the medication, an almost statistically significant 64% increased
risk.
FDA and GSK disclosed that, according to a
meta-analysis of previous studies conducted by the company in August
2006, participants who took Avandia had a 31% increased risk for
cardiovascular events. However, FDA did not take regulatory action on
Avandia because of clinical trial data submitted to the agency last
August. The data from the trial, which involved 30,000 patients, found
that participants who took Avandia had no increased risk for
cardiovascular events (Stein,
Washington Post, 5/22).
GSK on Tuesday published interim data from a
company study on the
NEJM
Web site. The data indicated no increased risk for cardiovascular events
associated with Avandia (Saul/Harris,
New York Times, 6/6).
Warning Details
The request from FDA for a black box warning for
the labels of Avandia and Actos involved only increased risk for heart
failure associated with the medications, not increased risk for heart
attacks (Alonso-Zaldivar,
Los Angeles Times, 6/7). Von Eschenbach said that
"these drugs were being prescribed to patients with significant heart
failure," despite current warnings on the labels of the treatments
(Rubin,
USA Today, 6/7).
He said that FDA has not reached a conclusion about
whether Avandia and Actos increase risk for heart attacks and continues
to analyze related trial data. An FDA advisory committee this summer
plans to address the issue (Cohen,
Newark
Star-Ledger, 6/7).
GSK, Takeda Response
GSK spokesperson Nancy Pekarek said that the
company is "in discussions with the FDA about label changes" for Avandia
but has "not agreed to any wording" (Newark
Star-Ledger, 6/7).
Moncef Slaoui, chair of research and development at
GSK, said, "The most important message today for the committee and the
public is this: The cardiovascular profile of Avandia is comparable to
that of the two other oral anti-diabetes medicines that are most widely
used" in the U.S. (Lopes,
Washington Times, 6/7). According to Slaoui, GSK has
conducted 116 trials of Avandia that have involved more than 52,000
patients (Vollmer,
Raleigh
News & Observer, 6/7).
Takeda officials in a statement said that the
company has entered discussions with FDA to develop a black box warning
for the label of Actos to "heighten awareness of the risk" for heart
failure. However, Takeda officials said that they support the "safety
and efficacy of Actos when used according to its label," adding that
trials have found no increased risk for heart attacks associated with
the medication (Newark
Star-Ledger, 6/7).
Congressional Response
Rep. Henry Waxman (D-Calif.) said, "FDA dropped the
ball" in efforts to ensure the safety of Avandia (Raleigh
News
& Observer, 6/7). Avandia is "a case study of the need for
reform of the nation's drug safety laws," Waxman said, adding, "Millions
of diabetics who have taken Avandia have not been well-served by our
regulatory system" (Los
Angeles Times, 6/7).
During the hearing, "Republicans accused Democrats
... of needlessly scaring patients and of vilifying a company when it
wasn't at all certain that" safety risks exist, according to the
Baltimore
Sun (Rockoff, Baltimore
Sun,
6/7). Rep. Darrell Issa (R-Calif.) accused committee Democrats of
"politicizing science," adding, "This does look like in fact that this
was a political concoction to anecdotally go after a company, and I
object to it" (Harris,
New
York
Times, 6/7). Issa said, "There is not a clear and present
danger with Avandia" (Washington
Times, 6/7).
Legislative Possibilities
Waxman prior to the hearing said that he would
introduce a bill (HR 1561) as an amendment to legislation to reauthorize
the Prescription Drug User Fee Act to improve FDA oversight of
prescription drug safety (Armstrong,
CQ
HealthBeat, 6/6). Among other provisions, the legislation
would allow FDA to require pharmaceutical companies to conduct studies
of the safety of new medications after they reach the market (Edney,
CongressDaily, 6/6).
Waxman said, "FDA needs the will, the resources and
the authority to be a more effective watchdog of drug safety" (Stein,
Washington Post, 6/7).
However, von Eschenbach said that FDA requires
additional funds, not additional authority, to ensure prescription drug
safety. According to von Eschenbach, proposals that would separate the
prescription drug approval and medication safety functions of FDA are
"more destructive than constructive" (Harris,
New
York
Times, 6/7).
Opinion Piece
Lawmakers should question the "methods and motives"
of Nissen, who bypassed FDA and began "strategizing" with Rep. Henry
Waxman (D-Calif.) "well before rushing to save the public from
cardiovascular Armageddon" with the publication of his study on the
safety risks of Avandia, Peter Pitts, president of the
Center for Medicine
in the Public Interest and a former FDA associate
commissioner, and Robert Goldberg, vice president of the center, write
in a
Washington Times opinion piece. According to the
authors, Nissen "has positioned himself as the nation's de facto drug
regulatory czar," but he "has his own credibility gap to deal with."
The authors write, "Nissen regularly claims that
the pharmaceutical industry hypes the value of new medicines while
soft-pedaling or not publishing safety problems. Yet he had hawked early
clinical results of several drugs such as ones he had been paid to
study, including some that ended up causing heart attacks and kidney
failure."
The authors write, "For someone who is concerned
about the appearance of impropriety, Dr. Nissen's conduct is
characterized by a series of uncomfortable coincidences," adding, "Most
involve putting his career ahead of the safety of patients"
(Pitts/Goldberg,
Washington Times, 6/6).
Broadcast Coverage
Several broadcast programs on Wednesday reported on
the hearing. Summaries appear below.
>> ABC's "World
News": The segment includes excerpts of testimony from the
hearing (Stark, "World News," ABC, 6/6). Video of the segment and
expanded ABC News coverage are available
online.
>> CBS' "Evening
News": The segment includes comments from Rep. Chris Cannon
(R-Utah); von Eschenbach; Waxman; Nissen; and GSK CEO Jean-Pierre
Garnier (Andrews, "Evening News," CBS, 6/6). Video of the segment is
available
online.
The program also included a profile of Nissen (Cordes, "Evening News,"
CBS, 6/6). Video of the segment is available
online.
>> NBC's "Nightly
News": The segment includes comments from Nissen, Waxman,
Bruce Psaty of the
University of
Washington, Garnier and von Eschenbach (Costello, "Nightly
News," NBC, 6/6). Video of the segment is available
online.
>> NPR's "All
Things Considered": The segment includes comments from
Waxman, Issa, von Eschenbach and Nissen (Silberner, "All Things
Considered," NPR, 6/6). Audio of the segment is available
online.
>> PBS' "Nightly
Business Report": The segment includes comments from von
Eschenbach; Buse; Slaoui; and Chris Viehbacher, president of U.S.
pharmaceuticals at GSK (Gersh, "Nightly Business Report," PBS, 6/6). A
transcript of the segment is available
online.
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