The Konformist

KON4M 99
July 1999

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$cience 4 $ale

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

by Barbara Keeler and Steve Urow

"Apparently the public is entitled to every slimy detail in the Starr report but not relevant information about what we feed our children," complained one South Bay consumer at a recent Food and Drug Administration public forum, referring to the proposed phase-out of labels on irradiated food, and to unlabelled genetically engineered (GE) foods.

The consumer pointed out that food and drug law gives the FDA ample authority to require labels on GE foods. However, the FDA, ignoring warnings and concerns raised by their own scientists, ruled that GE foods are too similar to their conventional counterparts to require labels. Even so, panel members responded to requests for labels on GE foods, by asserting that safety was their first concern and their decisions were "based on science."

The May 12 forum at the California Science Center, intended to meet the requirements of the FDA Modernization Act of 1997, was called "Public Input on Public Health, FDA Listens to You." An announced goal was strengthening the science base of the agency.

Did the FDA listen? Was the input put in? Based on their comments, FDA representatives did more defending than examining of their science base. For example, when a consumer presented scientific studies establishing risks of genetically modified organisms and irradiated foods, panel members replied that different scientists present different findings. They were unmoved when another consumer cited warnings in the FDA's own literature about dangers of life-threatening allergic reactions, antibiotic resistance, and increased toxicity.

Panel members did not mention that scientific studies need funding, and most scientific studies examining the benefits and safety of drugs, food additives, GE or irradiated foods, and other consumer products are funded by the suppliers. Consumers did raise the question of bias in both the science base and the FDA evaluation of scientific studies. Several panel members bristled, telling one consumer her concerns were unfounded. They declared that they had seen no evidence of bias that served the interest of industry.

The listeners need not look far for such evidence -- they could read it in government documents or pick up a newspaper. Just in the last few months they could have read about members of the FDA panel that reassessed the risks of Rezulin, and the money they had received from its manufacturer; manufacturers of FDA approved drugs that force their funded researchers, through threatened loss of funding, to suppress or delay publication of negative evidence concerning the drugs they test; and FDA's primary fatty-acid expert on an FDA panel that ignored recommendations of experts at NIH and WHO and advised FDA to ban DHA in infant formula. The expert had worked for Ross Products, a formula company opposed to the addition of DHA. Found in breast milk and used in formula worldwide, DHA is important to vision and brain development. Meanwhile, FDA expresses no concern about the GE ingredients ubiquitous in infant formula.

In May, panel members could have read about the 25 million dollar research contract between Novartis, a leading producer of GE food seeds, and plant geneticists at UC Berkeley, giving Novartis 30 to 90 days to review research publications. From the National Academy of Sciences web site, they could learn that until recently one of these UC Berkeley plant geneticists was to sit on a panel convened by NAS to assess risks and benefits of specific genetically modified food crops. According to FDA panel members, EPA, FDA, and USDA regulators share science databases, so committee findings and recommendations will doubtless become part of the FDA science base.

The proposed composition of this NAS panel exemplifies the potential for bias that pervades the science base examined by government regulators. The NAS formed the committee to conduct an urgent -- and rushed -- study of genetically modified crops containing pesticide genes, such as crops producing bacillicus thuringiensis (Bt) toxins in their tissues. The study was generated by complaints about overregulation. At issue is the fact that the Environmental Protection Agency regulates these crops as pesticides; the companies make a pesticide claim, and the food plants, including parts consumers eat, are indeed engineered to kill insects. With the panel not yet finalized, an NAS spokesperson has already told callers that such regulation is inappropriate.

Of 12 proposed members, seven have past or present financial ties to the biotech or pesticide industry. For example, an attorney and a scientist have represented Monsanto and the biotech industry against federal regulators, four additional members receive direct or indirect funding from companies such as Monsanto and Novartis that produce genetically modified seeds, and another is a consultant for the pesticide industry.

As first proposed, the panel included none of the many qualified scientists whose findings raise concern about the risks of GMOs. It lacked scientists representing the environmental or consumer sector. During the first public comment period, the web document providing information about the proposed members failed to disclose the biotech industry funding of several members, including the plant geneticist from UC Berkeley. After a flood of letters from consumers, the plant geneticist from UC Berkeley stepped down, the NAS disclosed biotech funding sources on the posted bios of proposed members, Dr. Rebecca Goldburg, Environmental Defense Fund, was added.

NAS received more than 500 comment letters, most objecting to the composition of the panel, but how often do similar potentially biased studies escape the attention of consumer, health, and environmental advocates? How many studies are conducted by an industry - funded committee? How often does a venerated body such as the NAS confer legitimacy and an impression of objectivity on what may be a biased process?

The industrialization of academic research is taken as a given -- so much that after Goldburg's nomination, some consumer protesters dusted off their hands, gloating that they had achieved 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 the risks and benefits of unlabeled GMOs that every citizen will consume. Even equal representation of the public sector -- everyone -- and the biotech industry -- a narrow vested interest -- would be unbalanced.

Unfortunately this panel is probably better balanced than the overall body of research that comprises the science base of regulatory agencies. Who has the resources and incentive to fund such research, other than the affected industries? Where do the peers who review the research obtain their funds?

To FDA regulators who decide which studies to dismiss or ignore, we say that if a study manages to struggle out of the scientific community without industry funding, it merits close examination and should be weighed seriously by regulators. Funding sources of both researchers and peer reviewers should factor into the equation when regulators weigh and balance conflicting findings.

Meanwhile, qualified scientists have presented sufficient findings and raised sufficient concerns to warrant labeling genetically engineered foods -- at the very least. Some were presented June 17 at the National Summit on the Hazards of Genetically Engineered Foods. When FDA representatives were handed 500,000 signatures on petitions for labels on genetically engineered foods. Labeling would only stigmatize the foods, they claimed -- this in spite of warnings in FDA's own literature about dangers of life-threatening allergic reactions, antibiotic resistance, and increased toxicity.

FDA is also considering phasing out labels of irradiated food. Prudent consumers deserve the right to 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 they make informed choices.

Hello? FDA? Are you listening?


Barbara Keeler writes about health and the environment in news articles and in nutrition, health, science, and social studies textbooks.

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

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