The Public Policy

Sour Grapes Over BPA

When activists don't get their way at the U.S. Food and Drug Administration.

By 6.19.12

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Certain political activists and the peddlers of pseudo-science who support them have been in high dudgeon ever since the U.S. Food and Drug Administration issued its March 30 denial of a petition to ban bisphenol A (BPA) from food contact applications. BPA, a ubiquitous chemical, has been used safely for more than 50 years in polycarbonate plastics and in the lining of canned food to prevent bacterial contamination.

Research findings by federal government laboratory scientists, the results of which were announced last year, should have put the scare-mongering over BPA to rest. A human exposure study found that because of the way BPA is processed in the body, it would be virtually impossible for it to cause health effects in adults, children, or even fetuses. But the response from those who did not prevail in the FDA decision was sadly predictable: They smeared the agency and its scientific reviewers.

After more than two months of trashing the FDA, activists have taken a new tack to try to discredit the agency and its March decision. The argument, advanced by long-time BPA critic Frederick vom Saal and collaborator Patricia Hunt, claims there is a "Catch-22" imposed by the FDA on university researchers.

This disconnect is supposedly that the FDA rejected the conclusions of many experiments because researchers did not use enough laboratory animals due to federal restrictions on how many such animals may be used in experiments.

Vom Saal and his acolytes believe this to be the Silver Bullet that discredits the FDA's decision. But vom Saal, notorious for his ridiculous claim that feeding an infant with a shatterproof baby bottle was akin to giving the child a birth control pill, contradicts his own argument.

While
denouncing the FDA decision because of its protocols involving lab animals (in the same commentary appearing in two different publications on June 8 and June 10) , he states in both articles that "The FDA should know that the strength of conclusions that can be drawn from data is not directly dependent on the number of animals used."

On this count, vom Saal is correct. The FDA rejected arguments to ban BPA because none of the studies purporting to show harm conducted by vom Saal or anyone else demonstrated relevance to human health and the regulatory process. This central point is conspicuously absent from vom Saal's commentary because it does not mesh with his ideology. That's not how science works.

Vom Saal also hauled out the old cliché about the unreliability of research funded by industry, but that's another dog that won't hunt.

Vom Saal should know that FDA's various regulatory units routinely perform scientific reviews of industry-performed or funded research.

By implying an "industry-funding" conflict of interest, vom Saal neglects his own. Many university researchers, including vom Saal, are dependent to some degree on taxpayer-funded research grants. The formula among this cadre is simple: Find a way to show that something may cause harm and the tax dollars continue to flow for further research and for the care and feeding of the investigator. Research that shows no harm, on the other hand, runs the risk of turning off the spigot of grant money, and is seldom of interest to journal editors.

The FDA rejected the petition to ban BPA for a simple reason. There was no data that demonstrated harm or undue risk associated with normal consumer exposure to BPA. Recall the fundamental tenets of toxicology: Harm is a function of toxicity and exposure, and the dose makes the poison.

Scientists can and do disagree, but the incendiary approach of vom Saal and his collaborators coarsens the discussion and fails to advance either science or regulation. If there is anything toxic about BPA, it is the manner in which its ideological critics assault those with whom they disagree. Whether their unhappiness is driven by ignorance or self-interest, they have had their say and it is time to move on.

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About the Author

Henry I. Miller, a physician and former FDA official, is the Robert Wesson Fellow of Scientific Philosophy and Public Policy at Stanford University's Hoover institution.