Bad Court Ruling Could End Checks on Industry Funded 'Science'
Yesterday, the Washington Post noticed a disturbing trend that we have
been following for a long time – the corporatization of scientific
research ostensibly conducted by unbiased and trustworthy sources like,
in this case, the Food and Drug Administration.
Science has been twisted to serve corporate ends for decades – see the
tobacco industry’s "studies" showing that smoking is not dangerous.
Most of the time, these justifications for unhealthy or dangerous
products are given precisely the credibility they deserve – none.
Perhaps realizing this, the new trend is to funnel money behind the
scenes to get disreputable science published by reputable sources.
The FDA’s tarnished report on bisphenol A (BPA) is only the
most recent incident of corporatized science. In this case, the FDA
subcommittee reporting that an "adequate margin of safety exists for BPA at
current levels of exposure from food contact uses" was chaired by Martin
Philbert, acting director of the University of Michigan’s Risk Science Center. The problem is,
founder of Gelman Instrument Company (now Pall Life Sciences) and firm believer
that BPA is "risk free."
Gelman, whose company was once labeled the
second worst polluter in
And indeed, the Risk Science Center expects a permanent director to replace Philbert by the time Gelman’s grant
kicks in next year. But the Milwaukee Journal Sentinel reports that Gelman
and Philbert "talk often," and the Washington Post reports that Philbert failed
to put Gelman’s donation on his financial disclosure form. It all adds up to a
relationship that’s too close for comfort. As the New York Times says, "Consumers
need to know that any decision on BPA is completely unbiased – and that the FDA
Despite the dangers of a potential toxin being present in
hundreds of thousands of containers (including countless baby bottles), the
past few months have brought far worse consequences because of the
corporatization of science. Three other recent examples of the manipulation of
clinical studies by pharmaceutical companies have made press.
First, it came
to light that a clinical trial for the former Merck blockbuster drug Vioxx
had, in fact, been an elaborate marketing technique. The Annals of Internal
Medicine called it
"marketing in the guise of science." The practice, called a "seeding
had long been suspected but had not been proven until brought to light
Vioxx litigation. "The apparent purpose is to test a hypothesis,"
Annals wrote. "The true purpose is to get physicians in the habit of
prescribing a new drug."
Far from being just another type of trial, "seeding trials" constitute
review boards, researchers, doctors and patients. The documents
discovery show "that deception is the key to a successful seeding
Second, it was revealed that Merck employees were writing
papers on Vioxx and then recruiting physicians to take the credit (and lend
credibility). The Journal of the American Medical Association concludes:
This case-study review of industry
documents demonstrates that clinical trial manuscripts related to rofecoxib
[Vioxx] were authored by sponsor employees but often attributed first
authorship to academically affiliated investigators who did not always disclose
industry financial support. Review manuscripts were often prepared by
unacknowledged authors and subsequently attributed authorship to academically
affiliated investigators who often did not disclose industry financial support.
The author of that report, Joseph Ross, told the New York
Times, "it almost calls into question all legitimate research that’s been
conducted by the pharmaceutical industry with the academic physician."
Finally, the New York Times reports
that Pfizer "manipulated studies" on its epilepsy drug Neurontin.
Pfizer’s tactics included delaying
the publication of studies that had found no evidence the drug worked for some
other disorders, "spinning" negative data to place it in a more positive light,
and bundling negative findings with positive studies to neutralize the results,
according to written reports by the experts, who analyzed the documents at the
request of the plaintiffs’ lawyers.
The common thread connecting these cases is that the
pharmaceutical companies’ fraud was only revealed through litigation – which is
one reason why Wyeth v. Levine (Tort
York Times) is such an important case. In 2000, Diana Levine was given
Wyeth’s drug Phenergan to combat nausea associated with her painkillers. But
the drug was administered incorrectly, caused gangrene, which cost the
professional guitarist her right arm. Levine sued Wyeth because Phenergan’s
label did not mention that the method used to administer the drug would
inevitably cause gangrene. Wyeth appealed to the Supreme Court, arguing that the
FDA’s approval of Phenergan’s label immunizes it from Levine’s lawsuit.
If the Supreme Court sides with Wyeth, these lawsuits will
be blocked – forever. Since the FDA approval is based, in large part, on
the very sort of studies that have proven to be tainted, such a decision would
pervert Big Pharma’s incentives. If Big Pharma feeds the FDA misleading
information, it would be rewarded both with approval of its drugs and immunity
from accountability if those drugs injure consumers. Maybe that’s why the New
England Journal of Medicine filed an amicus brief urging the Supreme Court to
reject Wyeth’s argument.