H
Harry Hope
Guest
From Reuters, 7/24/07:
http://www.reuters.com/article/governmentFilingsNews/idUSN2421846020070725
FDA pulled reviewer off Glaxo drug
WASHINGTON (Reuters) -
A senior Food and Drug Administration scientist has told congressional
investigators that the FDA removed him or her from work on
GlaxoSmithKline Plc's drug Avandia after voicing concerns about the
safety of the diabetes pill, two senators said on Tuesday.
The unnamed FDA medical officer at one time was the primary reviewer
for Avandia, according to a letter sent to the FDA by Senate Finance
Committee Chairman Max Baucus, a Democrat, and Sen. Charles Grassley,
the panel's top Republican.
The scientist has believed since 2005 that there was enough evidence
for a strong "black box" warning on Avandia about a risk of congestive
heart failure, the senators said.
In a statement titled "Senators reveal effort by the FDA to suppress
scientific dissent and downplay safety concerns" released with their
letter, they said the reviewer was "sidelined after voicing safety
concerns" about Avandia.
The FDA reviewer "was told to stop participation in the review of
potential cardiovascular safety problems associated with Avandia," the
senators' letter said.
The senators said the scientist was interviewed by committee
investigators.
"This new allegation is especially significant and raises our level of
concern about FDA interference in safety decisions regarding Avandia,"
the letter said.
FDA spokeswoman Julie Zawisza said the FDA had received the senators'
letter and would respond.
In June, the FDA said it had asked for a black box warning about
heart-failure risk on Avandia and competing diabetes pill Actos, a
competitor made by Takeda Pharmaceutical Co Ltd..
Concerns about Avandia's heart risks arose in May when a study
published in the New England Journal of Medicine linked Avandia to a
43 percent higher chance of having a heart attack.
___________________________________________________
Wonder how much GlaxoSmithKline contributed to the Bush campaign.
Harry
http://www.reuters.com/article/governmentFilingsNews/idUSN2421846020070725
FDA pulled reviewer off Glaxo drug
WASHINGTON (Reuters) -
A senior Food and Drug Administration scientist has told congressional
investigators that the FDA removed him or her from work on
GlaxoSmithKline Plc's drug Avandia after voicing concerns about the
safety of the diabetes pill, two senators said on Tuesday.
The unnamed FDA medical officer at one time was the primary reviewer
for Avandia, according to a letter sent to the FDA by Senate Finance
Committee Chairman Max Baucus, a Democrat, and Sen. Charles Grassley,
the panel's top Republican.
The scientist has believed since 2005 that there was enough evidence
for a strong "black box" warning on Avandia about a risk of congestive
heart failure, the senators said.
In a statement titled "Senators reveal effort by the FDA to suppress
scientific dissent and downplay safety concerns" released with their
letter, they said the reviewer was "sidelined after voicing safety
concerns" about Avandia.
The FDA reviewer "was told to stop participation in the review of
potential cardiovascular safety problems associated with Avandia," the
senators' letter said.
The senators said the scientist was interviewed by committee
investigators.
"This new allegation is especially significant and raises our level of
concern about FDA interference in safety decisions regarding Avandia,"
the letter said.
FDA spokeswoman Julie Zawisza said the FDA had received the senators'
letter and would respond.
In June, the FDA said it had asked for a black box warning about
heart-failure risk on Avandia and competing diabetes pill Actos, a
competitor made by Takeda Pharmaceutical Co Ltd..
Concerns about Avandia's heart risks arose in May when a study
published in the New England Journal of Medicine linked Avandia to a
43 percent higher chance of having a heart attack.
___________________________________________________
Wonder how much GlaxoSmithKline contributed to the Bush campaign.
Harry