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.

Comments

[Becky McClain]

This is excellent reporting. The public needs to have a better understanding of how conflicts of interest operating within “corporatization of scientific research” are resulting in permanent negative impacts on pubic health and safety and human rights.

It seems absurd, even today, however, with our ongoing advancements in science, that there is little legal protection within the scientific community for those wishing to promote public health and safety while still promoting science. Most alarmingly, Freedom of Speech is being constrained to gag scientists who wish to speak out against unethical or unsafe practices. Threats of loss of job and discrimination are a reality. As a result of this lack of right, the numbers of cases involving unethical scientific behavior go severely under reported. As such, this encourages other scientists to engage in comparable unethical practices, with little conscience or fear of being caught. It becomes part of an excepted behavior within the scientific culture.

As your article suggests, litigation involving scientific misconduct is extremely important in bringing to light serious threats to the public’s safety. But due to the underreporting of such cases and cost of litigation of those that are reported, the actual numbers of cases that in fact do make it to court for the public’s enlightenment is scant at best. Accordingly, these scant numbers of cases significantly underestimate the prevalence of the problem. As a result, litigation unfortunately offers little financial deterrence to stop the abuse and unethical practices occurring within the scientific communities.

So it also is with public perception regarding litigation involving scientific misconduct. The public cannot make the connection to the analogy of “one roach seen in the cabinet means there are hundreds in the wall”. As such, it makes it difficult to embroil public outcry leaving the scientific community off the hook.

Conceivably to help solve the ethical problems occurring within the “corporatization of scientific research” we need to implement laws which provide greater transparency. For example, results of human clinical trials, those being either negative or positive, should be open for public review.

Most importantly, however, we need to institute effective whistleblower laws to protect scientist who speak for public welfare, safety and rights. Without freedom of speech, no amount of regulations or transparency will ever provide an answer to the glaring problem of conflict of interests within the scientific community today. We first must advocate and provide basic rights for scientists. Only then will scientists be able to lead the way toward positive change, improve the ethical culture within their community and to better promote and protect public health and safety.

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