FDA
Gave Glaxo Extra Year
To Profit Off Avandia
By Evelyn Pringle
13 July, 2007
Countercurrents.org
A
February 22, 2006 internal FDA memorandum, obtained by staffers of the
Senate Finance Committee, proves that safety officials within the agency
recommended that GlaxoSmithKline add a black box warning about congestive
heart failure to the label of the diabetes drug Avandia well over a
year ago.
The memo also shows that FDA reviewer Dr David Ross recommended a highlighted
boxed warning for CHF, a life-threatening condition that occurs when
fluid builds up in the lungs causing a severe shortness of breath that
requires immediate medical attention.
The memo also recommended that macular edema, a condition that causes
swelling of the retina and can lead to blindness, be listed as a serious
adverse event on the label.
Although the recommendations were approved by Dr Rosemary Johann-Liang,
the Deputy Director of the FDA's Division of Drug Risk Evaluation, they
were never added to Avandia's label.
Instead of forcing Glaxo to post warnings to protect Americans, top
FDA officials basically demoted Dr Johann-Lang for approving the warnings
to begin with.
Congestive heart failure "is a very, very clear adverse reaction
syndrome" with Avandia, Dr Johann-Lang told reporter, Rita Rubin,
according to an article in USA Today on June 11, 2007. She also noted
a concern that some patients might blame symptoms, such as shortness
of breath, on the underlying diabetes and mistakenly take more of the
drug.
Dr Johann-Lang has now left her position at the FDA for personal reasons,
but said in her interview with USA Today, that she might have tried
to figure out a way to stay "if the agency had a vision of promoting
and protecting public health."
However, her departure does not mean that the misconduct by senior FDA
officials will be overlooked. On June 4, 2007, Senator Charles Grassley
(R-Iowa) and the Senate Finance Committee sent a letter to the FDA Commissioner
Andrew von Eschenbach demanding answers to questions by June 20, 2007,
about the retaliation waged against the safety evaluators who tried
to warn the public about the risks of Anvandia a year ago.
Although Glaxo downplayed the risks, according to a June 1, 2007 report
by Andrea Gerlin for Bloomberg News, the FDA knew about risks associated
with Avandia as far back as April 1999, when GlaxoSmithKline executives
told the FDA that the drug caused "minimal" cardiovascular
side effects and "mild to moderate" fluid buildup,
The agency approved Avandia on May 25, 1999, even though some FDA advisory
panel members had recommended that more research should be conducted
to detect potential complications.
On February 8, 2001, the FDA Web site shows the agency approved revisions
to the Prescribing Information for Avandia to include a new warning
regarding cardiac failure and cardiac effects.
But 3 months later, Glaxo sales representatives were "denying the
existence of serious new risks associated with Avandia" in presentations
at Glaxo's promotional exhibit booth during the Annual American Association
of Clinical Endocrinologists Meeting in San Antonio, Texas on May 2-6,
2001, according to a July 26, 2001 FDA letter to Glaxo.
The letter also pointed out that Glaxo had already been warned about
this conduct several times. "Your promotional activities that minimize
serious new risks are particularly troublesome," it said, "because
we have previously objected, in two untitled letters, to your dissemination
of promotional materials for Avandia that failed to present any risk
information about Avandia or minimized the hepatic risk associated with
Avandia."
The untitled letters were sent to Glaxo on June 29, 1999 and October
20, 2000. "Despite your assurance that such violative promotion
of Avandia had ceased," the July 2001 letter states, "your
violative promotion of Avandia has continued."
In a December 3, 2006 interview, diabetes researcher Rury Holman of
Oxford University in the UK, an investigator in the Glaxo study known
as ADOPT, told Bloomberg News that the results of that study, which
were released in November 2006, were cause for concern.
"These people are early diagnosis, they haven't got complications,"
he said. "The fact that we're seeing these cardiovascular effects
in them we can't deny that."
The concern, he noted, was that a signal emerged in "relatively
healthy patients."
In addition, according to the FDA web site, significantly more female
patients who received Avandia in the ADOPT study, "experienced
fractures of the upper arm, hand, or foot, than did female patients
who received either metformin or glyburide."
In an all too familiar pattern with the Bush-controlled industry friendly
FDA, Americans were kept in the dark about the risks associated with
a drug in what many experts are calling another Vioxx-like disaster.
On May 23, 2007, Reuter's reported that Europe's watchdog, the European
Medicines Agency (EMEA), had taken action on the risks of Avandia last
year by strengthening the warnings on the drug.
"The situation in Europe is a little bit different to the American
situation because," the agency spokeswoman said, "in Europe,
Avandia is contraindicated in patients with heart failure anyway and
we have warnings about ischemia."
She also referred to a May 2007 study in the New England Journal of
Medicine, conducted by Cleveland Clinic cardiologist Dr Steven Nissen,
which found Avandia to be associated with a 43% increase in heart attacks
and possibly a 64% increase in cardiovascular death. The EMEA spokeswoman
explained that "the majority of the studies looked at in the Nissen
paper have already been assessed by the (the agency's expert) committee
and, partly due to that, the SPC (summary of product characteristics)
was updated in 2006."
Only after being boxed in a corner, on June 6, 2007, the Johnny-come-lately,
FDA Commissioner von Eschenbach, informed a US House Committee that
the FDA is now requesting that a black box warning about CHF be added
to the labels of Avandia and another diabetes drug Actos.
However, an extra year with a sleeping US watchdog paid off well for
Glaxo. According to a May 21, 2007 USA Today article, doctors in the
US wrote 13 million prescriptions for Avandia last year, generating
more than $2 billion in sales, according to figures from the data tracking
firm IMS Health. Three million prescriptions had already been sold by
the end of March 2007.
Persons seeking legal advice regarding Avandia can contact Baum, Hedlund,
Aristei, Goldman & Menzies Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/
http://www.avandia-heart-lawyers.com/
[email protected]
(Written as part of a series on Avandia sponsored by Baum Hedlund's
Pharmaceutical Litigation Department)
(Evelyn Pringle is a regular columnist for OpEd News and investigative
journalist focused on exposing corruption in government and corporate
America)
Leave
A Comment
&
Share Your Insights
Comment
Policy
Digg
it! And spread the word!
Here is a unique chance to help this article to be read by thousands
of people more. You just Digg it, and it will appear in the home page
of Digg.com and thousands more will read it. Digg is nothing but an
vote, the article with most votes will go to the top of the page. So,
as you read just give a digg and help thousands more to read this article.