ISIS Report 01/09/06
FDA Under Fire for Corporate Links that Compromise Science
Political interference in the process of science and rampant conflicts of
interest in scientific advisory panels are undermining the agency’s ability
to protect the public from dangerous drugs. Sam
Burcher
A fully referenced
version of this paper is posted on ISIS members’ website. Details
here
FDA under fire from its own scientists
The FDA is already deeply mired in controversy over drugs trials in Third World countries [1]
(FDA in Third World
drug trial scandals ,
this issue) The Union of Concerned Scientists (UCS) has fanned the fires by
releasing the results of a survey that demonstrates the pervasive
political influence on science at the FDA [2].
The survey was sent to 5
918 FDA scientists and elicited 997 replies. Almost one fifth of scientists
(18.4 percent) said that they “have been asked for non-scientific reasons
to inappropriately exclude, or alter technical information or their conclusions
in FDA scientific documents.”
This response ech oes previous public complaints
made by FDA scientists who said that their findings on the painkiller Vioxx produced
by Merck & Co were dismissed [3]. Merck eventually had to pull Vioxx from
the market because of a study that linked the doubling of heart risk to the
use of the drug. This is a serious
indictment of FDA’s lack of accountability, and one that compromises their
ability to protect public health and safety.
Other responses to the UCS survey showed that:
- 17 percent had been asked by FDA officials to provide incomplete, inaccurate
or misleading information to the public, regulated industry, media, or elected/senior
government officials
- 40 percent fear retaliation from voicing safety concerns in public
- 47 percent, that’s less than half, think that the FDA routinely provides
complete and accurate information to the public
- 61 percent knew of cases where Department of Health and Human Services
or FDA political appointees have inappropriately injected themselves into
FDA determinations of actions
- 81 percent agreed that the public would be better served if the independence
and authority of FDA post-market safety systems were strengthened.
Dr Francesca Grifo, Senior
Scientist and Director of UCS’s Scientific Integrity Programs [2] said, “FDA
leaders should act now to improve transparency and accountability and renew
the respect for independent science at the agency.”
Conflicts of interest rampant at the FDA
But how do drugs like Vioxx get onto the market in the first place? A
study published this year by Washington based consumer advocates The Public
Citizens Health Group [4] found that conflicts of interests were rampant within
the FDA’s 16 drug committees and 32 other advisory panels. In 73 percent of
the 221 drugs reviews conducted during 2001-2004,
there was a financial conflict of interest
with the affected company or product competitors involving one or more panel members.
Only one percent
of the 3 000 panellists were recused (disqualified) within the same period, despite substantial
conflicts involving investments exceeding $25 000, and grants
or contracts topping $100 000. In the case of Vioxx (and other controversial
painkillers such as Celebrex and Bextra) ten members with direct links to
the drug manufacturers were on the panel that approved them.
The barrage of criticisms
being heaped upon the FDA led
the agency to announce a major internal review of drugs advisory
committees in May this year. But critics feel that change is unlikely to come
from within the FDA itself. The fact that the review is internal cast doubts
over its sincerity.
Merrill Goozner, Director
of Integrity in Science, supports the internal review of the FDA’s advisory
committees prompted by the criticisms. He said [5]: “This should be turned
into more of a deliberative body without a stake in the outcome, rather than
a kind of good-old-boy network of people whose primary interest is to get
their hands on a new therapy either to test or for [their own] patients.”
FDA scientists criticised for corporate links
The FDA has been rightly criticised by US Congressman Maurice Hinchey,
an influential democrat. Hinchey blasted
the FDA scientific advisory panels as being little more than partially owned
subsidiaries of the pharmaceutical industry. He is so outraged that scientists
with conflicts of interest are allowed onto drug advisory committees that
it has spurred him on through the House of Representatives to attach a rider
to the FDA budget that would prohibit the agency from using conflicted panellists
[5].
But this strong move has been politically compromised;
the rider was lifted providing that potential conflicts are disclosed and
posted on the FDA’s website fifteen days before drug advisory committees convene
[ 6 ]. This effectively
maintains the FDA’s practice that permits a scientist with a conflict of interest
to apply for a waiver on the grounds that the individual’s experience outweighs
the seriousness of the conflict. It is a federal policy that critics are trying
to change.
There is a common consensus that the voting of the panel that approved Vioxx
would have been different had those members with links to the pharmaceutical
industry been excluded. In the interest of Public Health there must be more
transparency about the information presented to FDA drugs committees, and more
stringent rules on conflicts of interest.
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