(Photo: Reuters)
Major
pharmaceutical companies are engaging in "pay to play" arrangements
that allow them to shape public policy on painkiller testing rules and
regulations, according to e-mails obtained by a public records request.
The Washington Post reports:
A scientific panel that shaped the federal government’s policy for
testing the safety and effectiveness of painkillers was funded by major
pharmaceutical companies that paid hundreds of thousands of dollars for
the chance to affect the thinking of the Food and Drug Administration,
according to hundreds of e-mails obtained by a public records request.
The e-mails show that the companies paid as much as $25,000 to attend
any given meeting of the panel, which had been set up by two academics
to provide advice to the FDA on how to weigh the evidence from clinical
trials. A leading FDA official later called the group “an essential
collaborative effort.”
"They are getting a huge amount for very
little money (impact on FDA thinking, exposure to FDA thinking, exposure
to academic opinion leaders and their expertise, journal article
authorship, etc.) and they know it," explains researcher behind the
scheme.
The emails show exchanges between two medical professors at the head of a yearly clinical trials review panel known as
IMMPACT.
In the exchange, professors Robert Dworkin of the University of
Rochester and Dennis Turk of the University of Washington discuss
funding for the event and their inclusion of 14 pharmaceuticals
companies who paid up to $25,000 each for admittance this year alone.
In these IMPAACT meetings, a panel of scientists, representatives
from the FDA, the National Institute of Health (NIH) and the
participating major pharmaceutical companies discuss the safety of
individual painkillers and the procedures and results of clinical
trials.
Together, the group produces and publishes scientific guidelines and
“consensus” statements on the testing of the drugs, which Bob Rappaport,
the chief of the FDA’s analgesic division and an attendee of many
meetings of the group, has
called “a wealth of opportunity for communication” that is “approving new analgesic drug products.”
In regards to the "fee" taken from pharmaceutical companies to
partake, Prof. Dworkin explicitly explained the rationale in an email to
partner Prof. Turk:
20k is small change, and they can justify it easily if they want to
be at the table. Everybody has been very happy with [the meetings] and
they are getting a huge amount for very little money (impact on FDA
thinking, exposure to FDA thinking, exposure to academic opinion leaders
and their expertise, journal article authorship, etc.) and they know
it.
“These e-mails help explain the disastrous decisions the FDA’s
analgesic division has made over the last 10 years,” Craig Mayton, the
Columbus, Ohio attorney who made the public records request to the
University of Washington, told
The Washington Post. “Instead of
protecting the public health, the FDA has been allowing the drug
companies to pay for a seat at a small table where all the rules were
written.”
The emails reveal a "pay-for-play arrangement" where companies buy access to policy-shaping,
said Michael Carome, director of health research for the watchdog group Public Citizen.
"The whole picture is a troubling one and it warrants an independent investigation," said Carome.
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