Why the new NIH ethics rules are bad for the agency - and the public health

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This article appeared on MedicalProgressToday.com.

The National Institutes of Health (NIH) is now reconsidering the overly restrictive ethics rules it recently released for its employees - about what they can and cannot do on their own time, dictating what stocks they and their families can and cannot own. Let us hope the rules are never implemented. The restrictions would shackle researchers ability to pursue collaborative projects, and would jeopardize the quality of scientific work at our nation's prestigious research labs.

Under the new rules, NIH employees cannot be paid to consult, speak, write or teach for any medical-device manufacturer, pharmaceutical or biotechnology company, health care provider, or insurer, trade or professional group. Further, employees cannot own more than a total of $15,000 in drug, biotechnology or other related company stock.

In essence, the NIH is restricting any type of interaction between its employees and the private sector - all in the hope of eliminating what it believes is a potential conflict of interest with NIH pursuits.

These rules reverse the much more liberal policies of former NIH Director Harold Varmus, who allowed researchers to consult for drug and biotech companies. Those policies were intended to foster closer collaboration between NIH employees and private industry - in the interest of promoting scientific discoveries and their application to products that would promote health.

The new restrictions were promulgated by current NIH Director Elias Zerhouni, after some media reports claimed that NIH employees were receiving hundreds of thousands of dollars from drug companies, and were not disclosing these arrangements as required. An initial investigation seemed to reveal widespread ethics-lapses.

A subsequent investigation, however, has cleared the vast majority of researchers of any wrongdoing. The culprit: bad government record keeping. By the time the NIH completed its internal audit, however, the damage had already been done. Rather than taking the time to discover the truth and discipline a few instances of misconduct, the NIH overreacted. As the Hoover Institution's Dr. Henry Miller commented in the Los Angeles Times, "The NIH has used a bazooka to kill a mosquito."

Bad News for Government Scientists

The new, restrictive regulations are bad news for government scientists, and for consumers who hope to benefit from the basic research those scientists do. Unnecessarily stringent restrictions will drive our nation's top scientists away from working at NIH. Pharmaceutical and biotech companies will be deprived of access to this country's top biomedical scholars.

Worst of all, the notion that scientists with any relationship to corporations are by definition non-credible will be reinforced. This will create an insidious dichotomy between good scientists - who have no connection with corporations - and suspect scientists, who have such questionable ties.

Yes, we must have policies in place at federal research institutes, requiring that corporate funding, sponsorship and consultant arrangements be disclosed. Researchers with any significant financial stake in applicants with grants pending to the NIH must recuse themselves from reviewing those applications. NIH staffers who fail to disclose these relationships should be punished sternly.

But the current NIH response is a self-destructive overreaction.

Full Disclosure - of Non-Naderite Thinking

The NIH s rush to judgment is the result of increasingly strident claims by self-appointed consumer advocate groups - and by the editorial boards of some of our country's most prestigious medical journals - that association with industry is, by definition, a corrupting force. These claims have been accepted by many - even in Congress without any critical appraisal.

Many of these claims may be traced back to a calculated, sophisticated smear-campaign. In 2001, the Ralph Nader-inspired Center for Science in the Public Interest launched what it called the "Integrity in Science" project. This project was ostensibly committed to providing information on the financial links between specific scientists, organizations and industry. As CSPI put it at the time, it was "concerned about the link between industry and science, and how the demands of the former can undermine the public interest mission of the latter."

Supporters of these "full disclosure" policies (and the more suffocating NIH rules, which prohibit even perceived "ties" to corporations) argue that these disclosures and restrictions are in the interest of consumers, and have no pejorative implications for individual scientists or negative effects on free and open debate on scientific issues.

Whatever its stated intent, the CSPI s agenda has one very practical consequence: to create a dichotomy of credible vs. non-credible scientists - and thereby to discourage what would otherwise be valuable interactions between America's top research and commercial-employed scientists.

If this dichotomy becomes established, Nader and his allies will directly benefit. Scientists who depart from their own alarmist, anti-corporate rhetoric will be removed from advisory and decision-making roles. Having silenced competing points of view, the media and government will be forced to rely on Nader-blessed scientists for commentary. Perhaps that is the real conflict of interest here.

Advocating for clear and consistent disclosure of commercial ties from high-ranking NIH staffers is one thing. Ostracizing scientists who help companies develop new drugs, medical devices, and diagnostic tests for AIDS, Alzheimer s, and myriad other diseases is a purely political ploy.

Fallout from NIH Restrictions

The wholesale assault on scientists who collaborate with industry rests on a thinly veiled assumption that scientists are routinely corrupted for cash, and have no professional allegiance to sound, scientific research. That may be true for a few scientists, who should be barred from working at NIH in the first place. But for the overwhelming majority of those who have dedicated their careers to scientific pursuits, it is an appalling, unjustified insult.

The reality is that corporations - particularly start-up biotech companies - turn to the best and brightest scientists at the NIH for expert advice and guidance as they shepherd their inventions through a long, expensive, and arduous development and regulatory process. Isolating these companies from the nation s best and brightest scientists would only hurt the patients and consumers who depend on breakthrough discoveries for relief from death and disease. In fact, the case can easily be made that scientists who regularly consult with industry are more qualified than their peers who do not.

The irony is that all scientists have personal ideologies, motivations, unique goals and individual agendas, all of which can introduce bias into research. Scientific work should be carefully evaluated on its merits - not on the basis of broadsides by consumer groups who themselves have blatant ideological axes to grind.

In the interest of advancing scientific research and promoting medical innovation that will benefit American consumers, the NIH should relax its unnecessarily restrictive policy on thousands of NIH employees and concentrate on addressing the handful of ethical abuses that do occur.