Tc
Mon, Nov-20-06, 06:15
http://www.newstarget.com/015741.html
Conflicts of interest: How Big Pharma influences the FDA's
drug approval process at the expense of public safety In a
recent eight-to-one vote, an FDA panel recently recommended
approval of the diabetes drug Pargluva, despite concerns that
it could cause potentially serious heart problems.
Astoundingly, the decision was made without the help of a
cardiologist, since the panel's lone heart expert declined to
participate due to a potential conflict of interest. The vote
marked the second time in a one-week period that questions
arose over conflicts of interest at the FDA. Prior to the
advisory panel's recommendation on the Bristol-Meyers Squibb
drug Pargluva, a separate panel, with some of the same members
as the Pargluva panel, voted to approve Exubera, an inhaled
form of insulin made by Pfizer in partnership with
Sanofi-Aventis and Nektar Therapeutics.
Following the Exubera recommendation, an analysis by the
Center for Science in the Public Interest showed three of the
panel's nine voting members had previously consulted with or
spoken for Pfizer or Nektar Therapeutics, and the panel
chairman - although he voted against approval of the drug -
held stock in Pfizer. Some of these same members participated
in the panel that approved Pargluva, and despite their vested
interests in the drug industry, one of the panel members was
given a waiver that allowed him to vote on Pargluva. Two other
panel members were granted waivers to vote on both Exubera and
Pargluva, according to the CSPI analysis.
In addition to those who received waivers, another member of
the Pargluva advisory panel declined to participate because of
a potential conflict of interest. Dr. Jorge Plutzky, the
Pargluva advisory panel's sole cardiologist, opted out of the
approval process because he had conducted extensive research
on PPAR-agonists, the type of drug subject to approval.
However, while Dr. Plutzky may have removed himself to avoid
problems with conflict of interest, the fact that a conflict
of interest existed in the first place posed problems, since
his absence meant the panel lacked the expertise of a heart
doctor. This is particularly troubling since the main argument
against Pargluva is that it might double the risk of
cardiovascular disease in diabetics.
An Oct. 20 article in the Journal of the American Medical
Association, by Drs. Steven E. Nissen, Kathy Wolski and Eric
J. Topol, points to the significant cardiovascular risks posed
by Pargluva. After reviewing the same briefing documents
presented to the advisory panel, the article's authors
concluded that the drug more than doubled the risk of
potentially fatal heart attacks (2.11 percent of diabetic
patients taking Pargluva experienced cardiovascular problems
like congestive heart failure, stroke, heart attack and death,
compared to 0.81 percent of patients taking a placebo). The
nature of these risks makes the absence of a cardiologist in
the drug's approval process a significant concern.
In the wake of these and other FDA decisions that have
brought conflicts of interest to light, the fiscal year 2006
Agriculture/FDA appropriations bill will allow for advanced
public notice when a scientist with a conflict of interest
is to serve on an advisory panel. According to an Oct. 27
CSPI press release, the bill will require the public be
given 15 days notice when the FDA wants to put an individual
with a potential conflict of interest on one of its 30
advisory panels. Waivers granted to scientists, along with
their potential conflicts, must be published for public
viewing. Up to now, these items have been kept secret from
the public for years.
Although the CPSI hails the provisions of this new bill as a
"step in the right direction," it also recognizes that it is
not enough. While public disclosure gives the public the power
to evaluate FDA activity more carefully, many argue that what
the FDA needs is a group of scientists free from all conflicts
of interest.
The CSPI continues to push for this, saying in the press
release, "CSPI believes the FDA can find qualified scientists
without conflicts of interest to serve on all of its advisory
panels. That's why the waivers should be disallowed entirely.
At the least, the present disclosure bill could have been made
stronger by forbidding scientists with waived conflicts of
interest from voting at the conclusion of a committee's
deliberations."
After the Vioxx scandal left so many individuals questioning
the legitimacy of the FDA's drug approval procedure, it is
clear that the FDA has a long way to go in smoothing out this
process. When advisory panels are tainted with conflicts of
interests, it becomes difficult to trust the decisions these
panels make, and this has major implications for public
health. The bottom line is, there should be a divide between
the individuals approving drugs and the companies making those
drugs. Individuals with financial ties to the drug industry
should not be approving drugs for public use. It should be
important to all of us that the FDA find honest, independent
scientists and researchers who work for the public, not the
pharmaceutical industry.
****
TC
Conflicts of interest: How Big Pharma influences the FDA's
drug approval process at the expense of public safety In a
recent eight-to-one vote, an FDA panel recently recommended
approval of the diabetes drug Pargluva, despite concerns that
it could cause potentially serious heart problems.
Astoundingly, the decision was made without the help of a
cardiologist, since the panel's lone heart expert declined to
participate due to a potential conflict of interest. The vote
marked the second time in a one-week period that questions
arose over conflicts of interest at the FDA. Prior to the
advisory panel's recommendation on the Bristol-Meyers Squibb
drug Pargluva, a separate panel, with some of the same members
as the Pargluva panel, voted to approve Exubera, an inhaled
form of insulin made by Pfizer in partnership with
Sanofi-Aventis and Nektar Therapeutics.
Following the Exubera recommendation, an analysis by the
Center for Science in the Public Interest showed three of the
panel's nine voting members had previously consulted with or
spoken for Pfizer or Nektar Therapeutics, and the panel
chairman - although he voted against approval of the drug -
held stock in Pfizer. Some of these same members participated
in the panel that approved Pargluva, and despite their vested
interests in the drug industry, one of the panel members was
given a waiver that allowed him to vote on Pargluva. Two other
panel members were granted waivers to vote on both Exubera and
Pargluva, according to the CSPI analysis.
In addition to those who received waivers, another member of
the Pargluva advisory panel declined to participate because of
a potential conflict of interest. Dr. Jorge Plutzky, the
Pargluva advisory panel's sole cardiologist, opted out of the
approval process because he had conducted extensive research
on PPAR-agonists, the type of drug subject to approval.
However, while Dr. Plutzky may have removed himself to avoid
problems with conflict of interest, the fact that a conflict
of interest existed in the first place posed problems, since
his absence meant the panel lacked the expertise of a heart
doctor. This is particularly troubling since the main argument
against Pargluva is that it might double the risk of
cardiovascular disease in diabetics.
An Oct. 20 article in the Journal of the American Medical
Association, by Drs. Steven E. Nissen, Kathy Wolski and Eric
J. Topol, points to the significant cardiovascular risks posed
by Pargluva. After reviewing the same briefing documents
presented to the advisory panel, the article's authors
concluded that the drug more than doubled the risk of
potentially fatal heart attacks (2.11 percent of diabetic
patients taking Pargluva experienced cardiovascular problems
like congestive heart failure, stroke, heart attack and death,
compared to 0.81 percent of patients taking a placebo). The
nature of these risks makes the absence of a cardiologist in
the drug's approval process a significant concern.
In the wake of these and other FDA decisions that have
brought conflicts of interest to light, the fiscal year 2006
Agriculture/FDA appropriations bill will allow for advanced
public notice when a scientist with a conflict of interest
is to serve on an advisory panel. According to an Oct. 27
CSPI press release, the bill will require the public be
given 15 days notice when the FDA wants to put an individual
with a potential conflict of interest on one of its 30
advisory panels. Waivers granted to scientists, along with
their potential conflicts, must be published for public
viewing. Up to now, these items have been kept secret from
the public for years.
Although the CPSI hails the provisions of this new bill as a
"step in the right direction," it also recognizes that it is
not enough. While public disclosure gives the public the power
to evaluate FDA activity more carefully, many argue that what
the FDA needs is a group of scientists free from all conflicts
of interest.
The CSPI continues to push for this, saying in the press
release, "CSPI believes the FDA can find qualified scientists
without conflicts of interest to serve on all of its advisory
panels. That's why the waivers should be disallowed entirely.
At the least, the present disclosure bill could have been made
stronger by forbidding scientists with waived conflicts of
interest from voting at the conclusion of a committee's
deliberations."
After the Vioxx scandal left so many individuals questioning
the legitimacy of the FDA's drug approval procedure, it is
clear that the FDA has a long way to go in smoothing out this
process. When advisory panels are tainted with conflicts of
interests, it becomes difficult to trust the decisions these
panels make, and this has major implications for public
health. The bottom line is, there should be a divide between
the individuals approving drugs and the companies making those
drugs. Individuals with financial ties to the drug industry
should not be approving drugs for public use. It should be
important to all of us that the FDA find honest, independent
scientists and researchers who work for the public, not the
pharmaceutical industry.
****
TC