by Ethan A. Huff
August 18, 2011
FDA commissioner Hamburg has
announced she's going to abandon the conflicts of
interest rules which were put in place after FDA
employees had been caught twisting the science to
support their favorite drug companies and medical device
Below, the full story on the
FDA's unabashed announcement that it wants to be corrupt
At a time when drug industry corruption
is reaching a pinnacle of public exposure, the US Food and Drug
Administration (FDA) is actually proposing eliminating one of the
few pseudo-effective measures in place that restricts the agency
from becoming a full-blown
Big Pharma "rubber stamp"
In a recent announcement, FDA Commissioner
Margaret Hamburg stated that
the agency may next year loosen certain conflict of interest
restrictions that prevent scientists with financial ties to the drug
industry from becoming members of FDA advisory panels.
There are 45 different FDA advisory committees that, according to
the FDA's own website, are supposed to obtain,
"independent expert advice on
scientific, technical, and policy matters."
In other words, these panels are
purportedly to be composed of objective, unbiased individuals that
do not have financial or other ties to the very companies about
which they are advising.
Makes sense, right?
Well, in the eyes of Commissioner Hamburg, these common sense
restrictions, which at least give the illusion that the FDA conducts
honest regulatory work on behalf of the people, are unreasonable and
must be eliminated.
Hamburg apparently believes that drug industry-funded "scientists"
are vital to
the FDA's work, having stated
publicly that allowing Big Pharma shills to serve on advisory
committees is essential if the agency is to get the information it
needs to make decisions.
"We have to be sure that FDA has
subject-matter experts that we need for our important decision
making," stated Hamburg.
But expecting to receive "independent
expert advice" from industry-sponsored consultants posing as
scientists rather than actual independent scientists, however, is
the epitome of inane - and this is precisely what Hamburg is
suggesting as a correct form of FDA policy.
Does the FDA
have the power to change its own regulatory restrictions?
Aside from Hamburg's senseless and illogical opinions about how best
to obtain crucial decision-making information, the other glaring
elephant in the room is the fact that the FDA can apparently change
its own regulatory restrictions at will.
What is the point of an agency having
conflict of interest restrictions placed on it when that very same
agency can simply change them when they are no longer convenient?
Last time we checked, Congress was still in charge of creating and
passing laws, not the FDA. But Commissioner Hamburg seems quite sure
of herself, presumably because of expressed congressional support,
that the FDA's conflict of interest laws will soon be history.
And it appears, based on the FDA's
released draft guidance, that the FDA is actually
the one in
charge of amending its own policies.
The FDA claims that it needs to loosen or eliminate the conflict of
interest policies from its advisory committee procedures because it
is unable to find enough members to serve on its committees.
According to a recent Bloomberg report, only 77 percent of FDA
advisory committee positions were filled as of March 2011, which
leaves 138 vacant positions out of 608 total.
But if the FDA is having a hard time filling these positions,
perhaps it would do best to begin looking for eligible candidates in
And Robert Weissman, president of
the non-profit consumer advocacy group Public Citizen, agrees,
having stated that the rules should not change because the FDA is
unable, or unwilling, to find independent scientists to fill its
"We need strong protection rather
than less," state Weissman, following Hamburg's statements to
his group about needed to relax or change the law.
A study published back in March by
researchers from the University of Pennsylvania's School of Medicine
discredits the FDA's claim, having found that about 44 percent of
cardiologists have no ties to the drug industry.
Eric Campbell, an associate professor of
medicine at Harvard University and one of the study's authors,
stated that the study,
"flat out dismisses this idea that
there are no experts who don't have relationships," a
claim being made by the FDA in
support of its proposed new guidelines.
"There are lots of people out there who are smart and who don't
have conflicts of interest," said Sid Wolfe, also with Public
Citizen. "It just takes much more work for the FDA to find them.
But the result is you have much less tainting of the panel
Tell the FDA
to do its job, not tailor laws to suit the agenda of special
According to the FDA's draft guidance, the agency published a final
rule on February 2, 1998, requiring clinical investigators who
submit marketing applications for drugs or medical devices to also
disclose whether or not they have financial ties to the companies
who make the products they reviewed.
Current guidelines also limit who can
serve on advisory committee positions.
Both of these policies can work, at least as long as the FDA is
willing to put in the work necessary to find qualified individuals
who are not on the payrolls of drug and medical device companies.
But the agency is demonstrating a pure
unwillingness to do this, and instead is planning to cave to the
drug industry and to certain lawmakers who are pushing to have the
law amended instead.
Though the official comment period for the FDA's proposed new
guidance for financial disclosure by clinical investigators ended on
July 25, it is still crucial to contact the FDA and tell it to stop
catering to special interests, and to leave be the conflict of
interest policies that help preserve what little integrity remains
in the agency's advisory committee process.
You can contact the FDA to oppose the new draft guidance by writing
Dockets Management Branch
Food and Drug Administration
5630 Fishers Lane, Room 10-61
Rockville, MD 20857
Or calling: (888) 463-6332
Be sure to reference Docket No. FDA-1999-D-0792
To contact FDA Commissioner Margaret Hamburg directly, you
can call her: (301) 796-5000
Or email her:
You can also contact your
representatives by visiting: