Bisphenol A -- Conflict of Interest in the FDA?

Charles Gelman, retired from Gelman Sciences, now donates his wealth through the Gelman Educational Foundation. Gelman is a vocal critic of chemical regulation and supporter of free-market organizations that fight regulation. The foundation gave a 5 million dollar gift to the University of Michigan School of Public Health Risk Science and Communication Center, which Gelman has called his "legacy". That center is directed by the head of the FDA panel which will review the safety of bisphenol A (BPA). Will the decision of the FDA committee be compromised?

Canada just announced its plan to place BPA on its toxic or hazardous chemical list, which will give the government unprecedented authority to ban the sale of bisphenol A containing polycarbonate baby bottles and to demand bisphenol-A-free packaging from baby formula makers.

The US lags behind Canada in the regulation of bisphenol A for a number of reasons, like the different politics and economics of BPA in each country; therefore the US moves ahead on regulating BPA more slowly, in a sort of two step forward, one step back pattern.

Last week, the Attorneys General from Connecticut, Delaware, and New Jersey asked 11 manufacturers of baby bottles and infant formula to stop using bisphenol A. Yet the federal Food and Drug Administration (FDA) steadfastly maintains that Bisphenol A poses little risk for humans. The agency contends that the estrogen related chemical is not dangerous in the doses the FDA predicts people will ingest, despite research showing otherwise.

In the FDA's last review, issued last April, the agency used industry sponsored studies to make its decision. People tend to jump to conclusions about the validity of industry data, using a study's funding source as a proxy for trustworthiness rather than examining the data. But their correct to be concerned about industry research in the case of BPA because hundreds of government and university studies show very different, more alarming results.

The House Energy and Commerce Committee plans to interview FDA Commissioner Andrew von Eschenbach to question him about the agency's procedure for rating the safety of BPA. While the first FDA results are under congressional investigation, a second committee chaired by Martin Philbert was also set up to review the first FDA decision.

Last week, in the continuing saga of bisphenol A policy, the Milwaukee Journal Sentinel revealed that the University of Michigan center that Martin Philbert heads received a $5 million dollar gift coincident to his appointment to the FDA BPA review committee. (The FDA would not be the first government agency to have a conflict of interest on BPA, recently an NIH subcommittee studying BPA was also found to have controversial links to industry.)

The donation was given to the University of Michigan's School of Public Health (SPH) Center for Risk Science and Communication by Charles Gelman, a retired manufacturer with strong views on regulation and chemical safety. The Sentinel reports that Gelman told them in an interview that bisphenol A was perfectly safe, despite the opinions of - in his words - "mothers' groups and others who don't know the science." According to the Sentinel's report, Gelman passed his opinions about bisphenol A on to Philbert, who claims to have refused to discuss the issue with his benefactor. Philbert's conflict of interest statement for the FDA did not list the donation.

Industry Secret: Can't Beat the Law? Make The Law.

Acronym Required dug around a little more. Charles Gelman is a well known figure in Michigan. He made his fortune founding and running Gelman Sciences, a maker of plastic filtration devices. For several decades the company polluted groundwater and aquifers in Michigan with 1,4-dioxane, (PDF!) listed in California as a known cancer causing chemical. The pollution was discovered in wells near the plant in the mid-eighties and the state's Department of Natural Resources (DNR) rated the Gelman Sciences site the second worst industrial waste site in the state. The DNR then took regulatory steps to ensure that the company cleaned up the waste. In response, Charles Gelman launched an offensive that included everything from suing one of its main customers, Dow Chemical for 'falsely advertising' that it stewarded its chemicals "cradle to grave" (dismissed in court); to staging a boisterous parade through town with local business leaders when the DNR was scheduled to meet.

While settling homeowners lawsuits against the company, Gelman Sciences staged an epic fight with the state documented extensively by the local media. The company commissioned its own $50,000 study from the University of Michigan to show that other commercial products also contained the chemical. Gelman Sciences installed their own copier at the DNR while it tried to dredge up evidence against the state. The company also ran smear campaigns against people and non-profits involved with any actions against the company. Several years into the battle, the company had spent more on lawsuits against the state than it would if it had cleaned up its pollution, according to a September, 1991 article in Corporate Detroit (Waldsmith, L.,The revenge of Charles Gelman.; Gelman Sciences' legal battle with the Department of Natural Resources).

Then Gelman began pouring efforts into public policy, as he told the Corporate Detroit reporter:

"One thing I've learned is that business has some responsibility to participate in drafting legislation and being active in the legislative process, rather than paying no attention to it at all. That's the way bad laws are written."

Charles Gelman has stuck to his belief that he was wrongly accused, in his experience with the state set a course for his future actions. In 1994 while criticizing the state's lack of science knowledge, Charles Gelman told a state hearing on natural resources that 1,4-dioxane is not harmful, and no scientific evidence proved it was. When Charles Gelman's Foundation gave the $5 million dollar gift to the university last summer, Gelman noted that his gift was driven by his experience with the state on 1,4-dioxane.

I have Five Million Dollars. Would you Like some Job Security?

In gifting his millions to the university center, according to announcements the University published, Gelman noted that chemicals are complicated, and "our vision is to help inform industry, government and the public about how to properly assess the benefits and hazards posed by technology (and chemicals in particular) in our society." His wife Rita added that they were particularly interested in assessing the risks versus benefits of chemicals.

The gift establishes an endowed professorship for the UMRSC Director (Philbert is now the acting director), and will pay for two new faculty, scholarship support for students, and the Risk Science Master's in Public Health curriculum.

The gift from Gelman Education Foundation to the Risk Center certainly wasn't an out of the blue. The U. Michigan risk center was originally established with a $2.9 million dollar grant from the Gelmans, which David Garabrant, the director at the time called, "the foundation upon which the center will be built". The Gelmans also make frequent smaller (hundred thousand dollar) donations. According to Gelman, the center is his "important legacy", something that "will make a difference" as the Gelmans noted when they gave the initial 2.9 million dollar grant.

It would be a quandary. If you were a professor, in times when grants are tight, and someone offered to give you that amount of money what would you do? Perhaps you'd open the center too, while promising on your home page that your work "adheres to the highest standards of academic and professional integrity", and secure your employment security. Would the money change your politics? Even a little? One can suspect that a five million dollar donation might sway a recipient, but there's no real proof. Furthermore, it's not clear what sort of FDA opinion the $5 million dollars to the center could buy. But distrust seems warranted in this case.

Spreading the Wealth Around

Gelman's education foundation gives hundreds of thousands of dollars yearly to various religious, education, medical and political organizations. Aside from the Risk Center, his science and political donations are a nominal slice of the pie, a thousand dollars here or there which amounts to a nod to a cause or ideology. But do these donations portend an agenda that belies a neutral mission for the Risk Center? Gelman's only political donations are predictable neoconservative organizations dedicated to free-market proliferation and opposed to regulation. These are the organizations listed on the Gelman Foundation's 2007 990:¹

• The CATO institute
• The Competitive Enterprise Institute
• CFACT
• The Heartland Institute
• George Mason's Tyler Cowen, who runs the Mercatus Foundation, the Center for Public Choice, and the James Buchanon Center for Political Economy.
• The Mackinaw Center for Public Policy
• The Manhattan Institute for Public Policy
• Reason Foundation
• American Counsel on Science and Health
• The Science & Environmental Policy Project (SEPP) (Fred Singer's Global Warming Skeptism organization)
• Capital Research Center
• The Independent Institute

Incidentally, FDAreview.org is also a project of the Independent Institute. FDAreview.org advocates that "FDA control over drugs and devices has large and overlooked cost that almost certainly exceed the benefits." FDAreview.org "favors adult freedom and hence the repeal of all forms of premarket approval."

Gelman is clear about his mission to fund the Risk Science and Communication and as he says, to provide the Risk Center with contacts that will help its mission. When Gelman gave the originating grant to the center he referred to Gelman Science's protracted fight with the state's Department of Natural Resources "a case in public confusion", which would have benefited from the center's 'neutral' science.

But is an organization really "neutral" towards public policy if one person with a very clear agenda establishes it, funds the director, the professors, the students and the post-docs, and provides the contacts to help define the mission? If you're a professor doing science and didn't share Gelman's strong ideological stance, could you endure the pressure? Would Gelman endow with his legacy an organization that didn't share his views? What say does the founding funder have in the backgrounds of the professors whom he funds?

Congress is asking whether this donation will sway the the FDA's bisphenol A committee chair. Members of the Energy and Commerce committee plan to investigate the donation, and House Appropriations agriculture subcommittee members are calling on Philbert to recuse himself from the committee. If Philbert remains on the FDA committee, and then goes on to OK BPA, can that decision be trusted by US citizens? Can the University of Michigan's School of Public Health Risk Science and Communication be trusted?

¹ Acronym Required has previously written about a number of these organizations and you can find more information at Sourcewatch, ExxonSecrets.org and other websites.

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Acronym Required has written numerous articles on BPA, starting with the 2005 article "Plastic Bottles: Protecting Your Baby, by the ACC"