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,

the Risk Science Center recently received a $5 million grant from Charles Gelman,

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 Michigan by the state’s Department of Natural Resources, may not have bad intentions.

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

is, too."

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

trial,"

had long been suspected but had not been proven until brought to light

during

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

fraud on

review boards, researchers, doctors and patients. The documents

obtained in

discovery show "that deception is the key to a successful seeding

trial."

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

Deform, New

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.