Tc
Mon, Nov-20-06, 06:15
http://www.the-scientist.com/news/display/24056/
Conflicts of interest at Federal agencies FDA plans to
review guidelines, while new report shows conflicts common
in NAS panels
[Published 24th July 2006 05:36 PM GMT]
--------------------------------------------------------------
-------------------
The debate over how to handle conflicts of interest among
experts appointed to US government advisory panels heated up
today (July 24), as the Food and Drug Administration (FDA)
announced it will look more closely at how it manages the
issue on its science panels.
For instance, the agency plans to revise the guidelines used
to determine when an expert with a conflict of interest
deserves a waiver, typically issued when the conflict is
deemed to be insignificant, or the scientist's expertise too
great to lose. In addition, the FDA plans to look at ways to
improve explaining to the public why some scientists
received waivers.
"There's more we can do to simplify how we communicate the
criteria we use to give waivers," FDA deputy commissioner for
medical scientific affairs Scott Gottlieb told The Scientist.
The FDA's plan to review its policy on waivers follows the
introduction of a bill in Congress last year that proposed
eliminating waivers altogether; if passed, no member of an FDA
advisory committee could have a conflict of interest.
The Center for Science in the Public Interest (CSPI) also
issued a report today that found that nearly one in five
scientists appointed to a sample of expert panels convened by
the National Academy of Sciences (NAS) had "direct financial
ties" to companies with a stake in the outcome of the debate.
Nearly half of panels contained an imbalance of interests,
with too many scientists with industry ties and not enough
scientists with alternative viewpoints, such as ties to
environmental or public interest groups, to "offset" the
imbalance, according to the report.
"I think that there is a fairly consistent pattern, in some
[NAS] committees - not all - that there is an imbalance,"
Merrill Goozner, director of Integrity in Science at CSPI,
told The Scientist. The NAS consistently puts out "pretty good
reports," Goozner noted, but having an excess of pro-industry
experts likely has subtle effects on more subtle questions,
such as how much dioxin is toxic.
"I believe there are scientists out there without conflicts of
interest who can serve on these committees and do a comparable
job" to experts with ties that could influence their thinking,
Goozner said.
But it often makes sense to include experts with ties to
industry on expert panels, Gottlieb argued. The best people in
every field will be approached on all sides, he said. "Those
kinds of active thought leaders are sought out - not just by
us, but by industry," he noted. "If no one else is looking for
their expertise, I don't know why we would."
FDA committees are made up of both standing committee members
and ad hoc experts chosen because of their expertise in a
given area, since it's administratively "almost impossible"
to convene an entirely new group of experts every time
there's an issue to debate, Gottlieb explained. And the
agency can't foresee years ahead what issues will come up
that will give a standing committee member a conflict of
interest, he said. It's "unrealistic" to try to eliminate
conflicts of interest, Gottlieb argued; the best solution is
to try to "manage" it, he said.
But the FDA does not always manage conflicts of interest, said
Curt Furberg at Wake Forest University, who is on the Drug
Safety and Risk Management committee through May, 2007. For
instance, Furberg attended the three-day hearing on the safety
of COX-2 inhibitors; some of the ad hoc members had "close
ties to industry," and most of them voted to keep the drug
Bextra on the market. (Furberg voted against leaving Bextra on
the market; the FDA asked Pfizer to withdraw the drug in
April, 2005.)
Furberg explained that a committee member's bias typically
becomes evident during discussions that take place away from
the public. And now, the committees have too many clinicians
who want to have more drugs available for their patients, he
added. It makes more sense, Furberg reasoned, to include more
experts with different expertise -- such as drug safety and
public health -- and eliminate conflicts of interest
altogether. "You can find people with no conflicts," he said.
Even Gottlieb admitted that the public appears to have lost
confidence in the way the FDA handles conflicts. For instance,
waivers for committee members are not always posted online
before the committee meets, and waiver documents are long and
hard to read, Gottlieb noted.
This afternoon, Gottlieb, Goozner, and Steven Nissen, of the
Cleveland Clinic Foundation and former chair of the FDA
Cardiovascular and Renal Drugs Advisory Committee, are
scheduled to join a panel of experts to discuss managing
conflicts of interest on government science panels at the FDA,
NAS, and EPA.
There's a "loss of public confidence in the FDA," said Nissen.
"The impression has been that there's something wrong."
***
TC
Conflicts of interest at Federal agencies FDA plans to
review guidelines, while new report shows conflicts common
in NAS panels
[Published 24th July 2006 05:36 PM GMT]
--------------------------------------------------------------
-------------------
The debate over how to handle conflicts of interest among
experts appointed to US government advisory panels heated up
today (July 24), as the Food and Drug Administration (FDA)
announced it will look more closely at how it manages the
issue on its science panels.
For instance, the agency plans to revise the guidelines used
to determine when an expert with a conflict of interest
deserves a waiver, typically issued when the conflict is
deemed to be insignificant, or the scientist's expertise too
great to lose. In addition, the FDA plans to look at ways to
improve explaining to the public why some scientists
received waivers.
"There's more we can do to simplify how we communicate the
criteria we use to give waivers," FDA deputy commissioner for
medical scientific affairs Scott Gottlieb told The Scientist.
The FDA's plan to review its policy on waivers follows the
introduction of a bill in Congress last year that proposed
eliminating waivers altogether; if passed, no member of an FDA
advisory committee could have a conflict of interest.
The Center for Science in the Public Interest (CSPI) also
issued a report today that found that nearly one in five
scientists appointed to a sample of expert panels convened by
the National Academy of Sciences (NAS) had "direct financial
ties" to companies with a stake in the outcome of the debate.
Nearly half of panels contained an imbalance of interests,
with too many scientists with industry ties and not enough
scientists with alternative viewpoints, such as ties to
environmental or public interest groups, to "offset" the
imbalance, according to the report.
"I think that there is a fairly consistent pattern, in some
[NAS] committees - not all - that there is an imbalance,"
Merrill Goozner, director of Integrity in Science at CSPI,
told The Scientist. The NAS consistently puts out "pretty good
reports," Goozner noted, but having an excess of pro-industry
experts likely has subtle effects on more subtle questions,
such as how much dioxin is toxic.
"I believe there are scientists out there without conflicts of
interest who can serve on these committees and do a comparable
job" to experts with ties that could influence their thinking,
Goozner said.
But it often makes sense to include experts with ties to
industry on expert panels, Gottlieb argued. The best people in
every field will be approached on all sides, he said. "Those
kinds of active thought leaders are sought out - not just by
us, but by industry," he noted. "If no one else is looking for
their expertise, I don't know why we would."
FDA committees are made up of both standing committee members
and ad hoc experts chosen because of their expertise in a
given area, since it's administratively "almost impossible"
to convene an entirely new group of experts every time
there's an issue to debate, Gottlieb explained. And the
agency can't foresee years ahead what issues will come up
that will give a standing committee member a conflict of
interest, he said. It's "unrealistic" to try to eliminate
conflicts of interest, Gottlieb argued; the best solution is
to try to "manage" it, he said.
But the FDA does not always manage conflicts of interest, said
Curt Furberg at Wake Forest University, who is on the Drug
Safety and Risk Management committee through May, 2007. For
instance, Furberg attended the three-day hearing on the safety
of COX-2 inhibitors; some of the ad hoc members had "close
ties to industry," and most of them voted to keep the drug
Bextra on the market. (Furberg voted against leaving Bextra on
the market; the FDA asked Pfizer to withdraw the drug in
April, 2005.)
Furberg explained that a committee member's bias typically
becomes evident during discussions that take place away from
the public. And now, the committees have too many clinicians
who want to have more drugs available for their patients, he
added. It makes more sense, Furberg reasoned, to include more
experts with different expertise -- such as drug safety and
public health -- and eliminate conflicts of interest
altogether. "You can find people with no conflicts," he said.
Even Gottlieb admitted that the public appears to have lost
confidence in the way the FDA handles conflicts. For instance,
waivers for committee members are not always posted online
before the committee meets, and waiver documents are long and
hard to read, Gottlieb noted.
This afternoon, Gottlieb, Goozner, and Steven Nissen, of the
Cleveland Clinic Foundation and former chair of the FDA
Cardiovascular and Renal Drugs Advisory Committee, are
scheduled to join a panel of experts to discuss managing
conflicts of interest on government science panels at the FDA,
NAS, and EPA.
There's a "loss of public confidence in the FDA," said Nissen.
"The impression has been that there's something wrong."
***
TC