Bias in the Science Base of Federal Regulation:
the Industrialization of Research

by Barbara Keeler and Steve Urow

Dr. Michael Phillips left the National Academy of Sciences last month to work for the trade association, Biotechnology Industry Organization. The timing of his departure, toward the close of a study he directed to assess the benefits and risks of genetically modified crops containing pesticide genes, raised these questions among consumer advocates: How long has Phillips REALLY been working on behalf of the biotech industry? Was the study biased? How many safety studies are biased by industry?

Prompted by complaints about overregulation, NAS formed a panel to study GE plants producing pesticides, such as bacillicus thuringiensis (Bt) toxins, in their tissues. Recommendations will be passed to federal regulators. At issue is that EPA regulates these crops as pesticides; suppliers make pesticide claims, and plants are engineered to kill insects. Before the panel was finalized, Phillips had already told callers that such regulation is inappropriate.

Isn't this a conclusion--a proffered answer to a question properly directed to the panel, investigated in the study, and answered AFTER the study, by panel members?

Another suggestion of bias was the composition of the panel recruited. Of 12 members, seven have past or present financial ties to biotech or pesticide industries. An attorney and a scientist have represented Monsanto and the biotech industry against federal regulators, four other members receive direct or indirect funding from GE seed producers such as Monsanto and Novartis, and another is a consultant for the pesticide industry.

During the first public comment period, biotech funding of proposed panel members was not disclosed on the bios posted on the NAS web. Asked by a journalist if NAS intended to post the biotech funding sources, Phillips said no--members were entitled to financial privacy. By contrast, NAS executive officer William Colglazier told the same journalist that funding sources should be posted.

Undisclosed was a $25,000,000 research contract between Novartis, a leading producer of GE food seeds, and plant geneticists at UC Berkeley. One of these geneticists was originally nominated for the panel.

As first proposed, the panel included none of many qualified scientists who raise concern about risks of GE crops, nor scientists representing the environmental or consumer sectors. After a flood of letters, the UC plant geneticist stepped down, NAS posted biotech funding sources, and Dr. Rebecca Goldburg, of Environmental Defense Fund, was added. Also added was another member with biotech funding.

How often do studies conducted by industry-funded committees escape public attention? How often does a venerated body such as NAS confer legitimacy and an impression of objectivity on a possibly biased process?

"Based on science" is how FDA representatives characterize their ruling that GE foods are too similar to their conventional counterparts to require labels. But what science? Most studies examining the benefits and safety of consumer products are funded by suppliers.

The industrialization of academic research is taken as a given--so much that after Goldburg's nomination, some protesters dusted off their hands, gloating over token representation. What's wrong with this picture? We contend that one scientist representing the public sector--in other words everyone--and seven scientists tied financially to affected industry--a narrow vested interest--is an inappropriate balance in a panel assessing risks and benefits of unlabeled GE crops that every citizen will consume.

Unfortunately the balance of the NAS panel may approximate that of the industry-friendly panels that evaluate research at regulatory agencies. News media have reported the financial connections between affected manufacturers and members of FDA panels that assess the risks of consumer products. Add the often cited revolving door between the personnel departments of regulatory agencies and the regulated industries, and what chance remains of regulatory decisions based on unbiased science?

And where would they find unbiased studies? Who has the resources and incentive to fund such research, other than affected industries? Who funds the peers who review the research? According to news reports, funders of research threaten loss of funding to force their researchers to suppress or delay publication of negative evidence.

If a study manages to struggle out of the scientific community without industry funding, it merits close examination and should be weighed seriously by the NAS and federal regulators who decide which studies to dismiss or ignore. When findings conflict, funding sources of researchers and peer reviewers should factor into the equation.

Laura Ticciati, co-author of GENETICALLY ENGINEERED FOODS: ARE THEY SAFE? (Keats) and Executive Director of Mothers for Natural Law, makes an excellent point about safety studies: "Unbiased studies assessing risks and benefits should take place before, not after, release of these organisms into the environment and the diets of children. Failing that, consumers deserve labels on GE foods so they can weigh all evidence for themselves." Such evidence should include the funding of studies that form the science base of regulatory decisions, and the financial ties of the advisors who evaluate them. Only then can consumers make informed choices.

Barbara Keeler, author of ENERGY ALTERNATIVES, (Lucent Books), writes about health and the environment in news articles and in nutrition, health, science, and social studies textbooks.

Steve Urow is regional coordinator of the Campaign for Food Safety, and founder of the Greenpeople online eco-friendly business directory.
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