Medical Device Daily National Editor

Does it ever seem that the more scientific studies you get, the more scientific controversy seems to follow – especially inflated by questions concerning the type of research used, and dose/exposure levels of chemicals?

Then we'll add in some other complicating factors: big money and suggestions that a regulator's conclusions may have been affected by public relations. Then comes the frequent FDA meeting intended to get more ... certainty?

Prime recent example: the FDA's latest draft report on bisphenol A (BPA), a chemical incorporated into plastics, those plastics used in a variety of consumer products, concluding that the evidence is insufficient to support a banning of the chemical — that conclusion lambasted by a variety of public health advocates, and set to stir even more controversy current BPA.

Following the recent release of the draft report, FDA has announced that it will hold a public meeting early next month to discuss the evidence behind the report and gather additional input.

Andrew von Eschenbach, commissioner, in his weekly web site message, "Andy's Take," said that the evidence supporting the "draft assessment of the safety of BPA in items that touch food" will be presented at the Sept. 6 meeting. Additionally, he said that it "provides a way to get the most current information to [the public] so that you can make informed decisions about using the wide variety of food packaging and food containers that use material like plastic."

Consumer Reports has issued reports on tests indicating that baby bottles made with polycarbonate can leach small amounts of BPA into formula, calculating that "a typical baby who drank formula sterilized by heating the bottle would be exposed to a BPA dose of about 4% of an amount that has adversely affected test animals ..." But it said that these babies "could be exposed to a BPA dose 40 times higher than ... a conservative estimate of safety."

Among the groups criticizing the conclusions of the draft is Natural Resources Defense Council (NRDC; Washington), with Jennifer Sass, PhD, a member of the NRDC's Health Program, telling Medical Device Daily that she fears the agency may have reached a final conclusion and unlikely to change its stance on BPA.

"I think this is their decision," she said, "but they've buried their head in the sand on this one."

She said that the evidence for BPA causing harm is "very strong ... extrapolating from many, many well-conducted, robust, significant animal studies."

Sass acknowledged that can only come from animal studies because it isn't possible to develop a comparator control group of humans, given that the use of BPA in products is so "widespread – it's almost impossible to get human data because everybody's exposed."

Summarizing the key concern expressed by many groups criticizing the FDA position on BPA, she said the key concern is the after-effects of exposure to the chemical, which may not be seen immediately. "Here's the issue: the major threat is to prenatal and early childhood development, and it should be worded that the effects might come later."

She noted while BPA use is common, many uses are "frivolous and can come out right away," many companies having said they will remove their use "right away."

The NRDC also is charging that FDA policy on the issue is being influenced by the chemical products industry, via public relations, with Sass specifically identifying the Weinberg Group as an organization delivering industry's message.

"The Weinberg Group was hired to put a good spin on a bad chemical in this case," she said. "This is one thing that Congress is looking into – the effect of the Weinberg group."

The Weinberg group was hired to put a good spin on a bad chemical in this case.

Corporate influence also was charged by a Boston-area group, Workgroup for Safe Markets. Mia Davis, with that organization, said, "The profits keep growing for Dow Chemical and other petrochemicalcompanies in the ACC [American Chemistry Council.] We're demanding public health be of greater importance than the wealth of these corporations."

The FDA's position is also somewhat undermined by another government agency determination.

Earlier this year, the National Toxicology Program (NTP) of the National Institute of Environmental Health Services, a unit of the National Institutes of Health, issued a report acknowledging "some concern" for BPA exposure in younger people based on effects in the prostate gland, mammary gland and an early onset of puberty in females" (Medical Device Daily, April 24, 2008).

The rating of "some concern" by the NTP is third on a five-point scale ("serious concern" at 1, "negligible concern" at 5). The group also acknowledged that the evidence comes from animal studies but said the "possibility that it may alter human development cannot be dismissed."

Another voice in the debate is that of Rep. Edward Markey (D-Massachusetts), who issued a statement saying that "the regulators are asleep at the wheel," and that he has introduced legislation to ban BPA.

Earlier this year health officials in Canada proposed banning BPA in polycarbonate baby bottles. Though they said they had no evidence concerning harm, they indicated that such a move would be "prudent."

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