NY TIMES Editorial: Ignoring the Warnings, Again? /Pharmalot: Robert Temple
Date: Fri, 25 May 2007 11:27:16 -0500 (CDT)
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org and http://ahrp.blogspot.com
FYI
Today's New York Times editorial, "Ignoring the Warnings, Again?" comments
on the revelations in The New England Journal of Medicine about yet another
lethal drug that FDA officials allowed to stay on the market without so much
as a warning about its cardiac risks.
http://ahrp.blogspot.com/2007/05/diabetes-drug-avandia-exposed-much-as.html
The edirotial begins by noting: "The latest findings on Avandia, a
top-selling diabetes drug, raise concerns both about its safety and about
the way the manufacturer and the Food and Drug Administration have responded
to signs of danger."
The Avandia data analysis by Dr. Steven Nissen, who had also been among the
experts who identified the Vioxx cardiac risk, kicked up a storm in the
media and Congress.
Robert Temple, MD, one of the most influential FDA officials at the Center
for Drug Evaluation & Research (CDER) has the dubious distinction of having
signed off FDA approval for marketing more hazardous drugs during the last
20 years than in FDA's history. He also bears major responsibility for
disregarding lethal drug effects after the drugs were marketed, and for
failing to ensure warnings disclosed the risks.
Dr. Temple is apparently miffed because his decisions to disregard drug
safety hazards--decisions that resulted in the deaths of thousands of
citizens--are coming to light and his reputation is on the line. Drug safety
experts in and out of the FDA who are analyzing previously hidden data of
drugs approved under Dr. Temple's watch put his professional judgment in a
very bad light.
His response to professional criticism: "It's a particular subset of people
who do that," Temple tells The RPM Report. "A lot of them over the years,
I've considered friends. But I'm probably re-evaluating that."
That response is a demonstration of the culture of arrogance under which
senior FDA officials hold sway.
Among the experts outside the FDA whom Dr. Temple dismisses as "a particular
subset of people":
Dr. Curt Furberg, a health policy professor at Wake Forest University,
University of Washington epidemiologist Dr. Bruce Psaty, and Dr. Ray
Woolsey, who heads the Critical Path Institute. They've all testified before
Congress, offering ideas about fixing the FDA.
But, as Ed Silverman of Pharmalot reports, "nobody gets more of a rise out
of Temple than Steve Nissen, the Cleveland Clinic cardiologist whose study
in The New England Journal of Medicine called into question the safety of
Avandia, and the actions of the FDA and Glaxo toward the drug, as well." Dr.
Temple is quoted saying: "I'm sort of stunned when he testifies at a hearing
that the leaders of a division always overruled their virtuous reviewers. He
served four years on the cardiorenal committee, and I can tell you he didn't
see that. So that's funny thing to say."
http://pharmalot.com/2007/05/temple_of_frustration_fda_bigg.php
That statement shows Dr. Temple to be out of touch with reality. As is
documented in the public record in testimonies by FDA drug safety officers,
Dr. David Graham, Dr. Andrew Mosholder, CDER officials have used
intimidation to silence safety officers, preventing them from reporting
their safety analyses to the public.
Did Dr. Temple forget FDA's twenty year record of denial, and
misrepresentation of evidence about the suicide risk posed by SSRI
antidepressants?
Did he also forget that senior FDA officials put a gag order on Dr. Andrew
Mosholder in an effort prevent him from presenting his analysis of the
pediatric SSRI antidepressant data showing a twofold increased risks of
suicidality?
And what about the criminal investigation that FDA administrators instituted
against Dr. David Graham and Dr. Mosholder in an effort to silence them
about concealed drug hazards ? http://www.ahrp.org/infomail/04/11/29a.php
The following statement by Dr. Temple borders on the delusional:
"I wish we responded more often, but our problem is they [experts such as
Drs. Nissen, Furberg, Psaty, woolsey] can say whatever they want and we have
to respond with perfect truth. If we ever made a mistake in a response, we'd
get creamed."
http://pharmalot.com/2007/05/temple_of_frustration_fda_bigg.php
The Times Editorial is couched in qualifying language (much as one uses when
reporting about the alleged crimes of an accused who has not yet been tried
or convicted). However, the editorial correctly pinpoints both
GlaxoSmithKline and the FDA as co-defendants in their failure to warn
physicians and the public about the life-threatening risk for diabetes
patients who take the diabetes drug Avandia:
"If the verdict goes against Avandia, the F.D.A. and Glaxo will have a lot
to explain. Congress will need to probe hard to determine what risks the
agency and the manufacturer were aware of and what they did or didnt do
to mitigate them."
American consumers have a right to be outraged inasmuch as the current FDA
administration has denigrated the meaning of the FDA seal of approval by
failing to examine the scientific evidence. FDA regualtors are taking their
cue from industry and ther consequences are catastrophic.
"They make a pill to cure heart disease in diabetics, but the pill increases
heart disease in diabetics.
Is this the most audacious one yet? Is this nuts? How do they justify
this in their minds? Genocide of fat people????" --Susan, from California
Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
~~~~~~~~~~~~~~~~`
THE NEW YORK TIMES
May 25, 2007
Editorial Ignoring the Warnings, Again?
The latest findings on Avandia, a top-selling diabetes drug, raise concerns
both about its safety and about the way the manufacturer and the Food and
Drug Administration have responded to signs of danger. It would be rash to
make definitive judgments until the F.D.A. completes a detailed analysis.
But the handling of this case bears disturbing resemblances to the Vioxx
debacle, in which early warning signs were ignored by its manufacturer until
the evidence of serious harm became inescapable and the drug was pulled from
the market.
Avandia was approved for sale in 1999 based on studies showing that it could
lower blood glucose levels in patients suffering from Type 2 diabetes, also
known as adult-onset diabetes. The assumption was that the drug could
alleviate some of the most damaging effects of the disease, such as heart
attacks and other cardiovascular ailments. But a paper just published in The
New England Journal of Medicine suggests that Avandia may instead increase
the risk of a heart attack by 43 percent and perhaps the risk of
cardiovascular deaths as well.
The study an analysis of the combined results of 42 previous studies that
compared people who took the drug with people who did not is not
definitive, and the absolute risk to any given patient is small. But the
study points to a risk that could potentially harm thousands of patients a
year. Its lead author was Steven Nissen, a cardiologist at the Cleveland
Clinic, who blew the whistle on the cardiovascular risks of Vioxx, which
adds to the sense of dij` vu.
Whats most troubling is the possibility that early warning signs were not
adequately heeded.
Seven years ago a leading diabetes doctor warned the F.D.A. of a worrisome
trend in cardiovascular deaths, two years later a safety monitoring group
within the agency expressed concern over cases of heart failure in patients
taking the drug. In late 2005 and again in August 2006 the drugs
manufacturer GlaxoSmithKline informed the F.D.A. that its own combined
analysis of various studies showed a 31 percent increase in adverse
cardiovascular events. But the company also cited studies that it said
showed no evidence of harm, and the F.D.A. concluded the findings were too
mixed to take immediate regulatory action.
Now, prodded by Dr. Nissens article, the agency has issued a safety alert,
is completing its own safety analysis and will convene a panel of experts to
review the data. The best hope for a definitive answer may lie in a clinical
trial that wont finish monitoring all enrolled patients until late next
year.
If the verdict goes against Avandia, the F.D.A. and Glaxo will have a lot to
explain. Congress will need to probe hard to determine what risks the agency
and the manufacturer were aware of and what they did or didnt do to
mitigate them.
~~~~~~~~~~~~~~~~~~
http://pharmalot.com/2007/05/temple_of_frustration_fda_bigg.php
May 23, 2007
Temple Of Frustration? FDA Biggie Speaks
Bob Temple has a sharp mind and a thick skin. But after 25 years at the FDA,
well, some things change. Lately, the director of the Office of Medical
Policy admits that some of the withering criticism of the agency is getting
under his skin.
"It's a particular subset of people who do that," Temple tells The RPM
Report. "A lot of them over the years, I've considered friends. But I'm
probably re-evaluating that."
Who's on the list? Curt Furberg, a health policy professor at Wake Forest
University, University of Washington epidemiologist Bruce Psaty, and Ray
Woolsey, who heads the Critical Path Institute. They've all testified before
Congress, offering ideas about fixing the FDA.
But nobody gets more of a rise out of Temple than Steve Nissen, the
Cleveland Clinic cardiologist whose study in The New England Journal of
Medicine called into question the safety of Avandia, and the actions of the
FDA and Glaxo toward the drug, as well.
"I've had perfectly civil conversations about various things with him, but
you know, I'm sort of stunned when he testifies at a hearing that the
leaders of a division always overruled their virtuous reviewers. He served
four years on the cardiorenal committee, and I can tell you he didn't see
that. So that's funny thing to say."
Separating the public remarks from the discourse during the usual review
process is tricky, he acknowledges, but he says he tries to be philosophical
about it.
"Some of the people that have different views have continued to serve on an
FDA advisory committee and been perfectly useful, so you kind of have to
divide up what they're doing in one phase from what they're doing in the
other and make the best of it."
"You don't like criticism, but people have a right to do it. I wish we
responded more often, but our problem is they can say whatever they want and
we have to respond with perfect truth. If we ever made a mistake in a
response, we'd get creamed."
You can read more of this except from RPM Report here;
And you can read the complete Temple profile here.
Posted by Ed Silverman
Comments
Laurie says:
Somehow I can't work up any empathy for Dr. Temple. His 25 years at the FDA
have coincided with the deterioration of the agency.
Posted May 23, 2007 1:44 PM
Kate Rawson says:
Thanks for the mention -- the longer Temple profile in The RPM Report can be
found here:
http://r.smartbrief.com/resp/gWzshuePkHsbwqCibvdvxOIY
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