Annals of Government Science

The regulatory agencies of the federal government that rely on scientific analyses to carry out their functions, whether it be protecting the environment or approving new drugs, routinely appoint outside committees to evaluate their work. The scientists on these committees are usually drawn from academia, but the specialized expertise needed to conduct these sophisticated reviews often leads agencies to pull scientists from independent research institutes and consulting firms, which often receive research funds from private firms.

To protect the process from undue influence, the government 35 years ago passed a law that said scientists who serve on these review panels could not have conflicts of interest, in other words, they couldn't have recently worked for a firm or a trade group with a direct stake in the outcome of the committee's deliberations. Nor should they come to the committee with a preconceived bias about its outcome. There were exceptions written into the law. The agency could waive a conflict of interest if the person's expertise was highly specialized, couldn't be obtained elsewhere, and needed to successfully carry out the committee's task. And scientists with perceived biases (having already written or conducted studies on the subject and come to strong conclusions, for instance) could also be appointed as long as their views with balanced by someone with a contrasting view of the subject.

There's been numerous studies, political strife and litigation over the make-up of these committees in recent years. The Bush administration's penchant for appointing religious conservatives to committees dealing with reproductive health or prominent global warming skeptics to committees contemplating climate change clearly violated the bias provisions of the law. The Food and Drug Administration has been challenged for its excessive use of conflicted advisers on its drug approval panels. The FDA reform law that goes to conference committee next month will consider limiting the number of waivers to one per committee.

The Environmental Protection Agency has received less scrutiny in this decade, but it, too, suffers from a surfit of conflicted scientists passing judgment on government studies that directly affect their employers' economic interests. This week, a coalition of consumer and environmental groups attacked the EPA for larding a proposed panel that will review its scientific evaluation of the health and cancer risks of acrylamide with scientists with close ties to companies and trade groups that either use or make the chemical. In a letter sent yesterday, the Center for Science in the Public Interest, the Environmental Law Foundation, and seven scientists pointed out that at least six of the 21 scientists being considered for slots on the panel have either worked or consulted for companies or trade groups that produce or use acrylamide.

Moreover, one nominee, a Harvard-based epidemiologist, clearly has a preconceived bias about the issue, since she has already written that acrylamide poses little or no cancer risk to humans. "The EPA needs to do a lot more work before the public will be assured that the final roster is balanced and free from conflicts of interest," the letter noted. "EPA’s failure to do so will cast a permanent cloud over the integrity and reliability of the committee's work."

Acrylamide, a commonly used industrial compound that is also produced by frying starchy food, is already listed as a neurotoxin and probable human carcinogen. The update to the EPA's risk assessment, which is due out September 15 and will be peer-reviewed by the panel, may impact a 2005 lawsuit by the California Attorney General, which is seeking cancer warning labels on acrylamide-containing foods. Food processors are looking forward to the review since they believe recent science would downgrade the chemical's danger thresholds and thus void the lawsuit, according to a May 8 Risk Policy Report published by Inside Washington Publishers (subscription required). "I suspect that the calculation of risk will be less than the existing [EPA] assessment," said Robert Fensterheim, president of RegNet Environmental Services, which provides consulting services to the chemical industry.

The EPA's decision to include Lorelie Mucci of Harvard Medical School on its list of candidates violated some basic rules of scientific conduct. She has authored several epidemiological studies in recent years that suggest there is no link between acrylamide and some cancers. Her first study was harshly criticized by experts in the field. "[Mucci's] published conclusions and public statements indicate excessive confidence in insensitive epidemiology studies to detect acrylamide's possible carcinogenicity. . . and a strong bias in favor of acrylamide’s non-carcinogenicity," the consumer and environmental groups noted in their letter.

It's likely that the EPA's draft risk assessment that will be released in September will at least make reference to her work. If it comes out the way industry expects it to come out, it is probable that it will rely on her conclusions, since she is one of the more prominent researchers in the field. That means that if the EPA puts her on the committee, it will put her in the position of evaluating her own research.

That is not an acceptable process. Yet it happens with some frequency at the EPA. When Congress gets done with their work on the FDA, the relevant committees might want to turn their attention to industry's close involvement with the advisory committees that set the nation's environmental standards.

Posted by gooznews at August 14, 2007 09:14 AM