The following has been taken from a section on conflict of Interest in the bisphenol-A controversy that I had intended to use as a case study in my thesis but later decided not to use. This exerpt looks at the Weinburg group and manufacturing science to order. It has far wider implications….
The U.S. House of Energy and Commerce investigates the Weinberg Group
On January 17, 2008 the U.S. House of Energy and Commerce announced the start of an investigation into the use of bisphenol A in products intended for use by infants and children. The Committee on Oversight and Investigations sent letters on that date to seven corporations that used, or manufactured BPA as part of their operations. In addition a letter was sent to the FDR Commissioner and on February 5, 2008 to the private consultancy firm The Weinberg Group.
Referring to the Chapel Hill expert panel consensus statement on BPA, the Chairman of the Committee on Energy and Commerce, Rep. John D. Dingell stated: “There is concern in the scientific community that this chemical, bisphenol A, may be harmful, both to adults and children, and some retail stores in Canada have pulled products from their shelves because it may harm adults. It would seem obvious that we would try to protect babies and infants from chemicals that may be considered dangerous to adults”.
The Chairman of the Subcommittee on Oversight and Investigations, Rep. Bart Stupak said that the investigation would focus on examining how the Food and Drug Administration (FDA) had come to its determination that BPA was safe for use in infant formula cans. According to the letter sent to the FDA, the committee wanted full details on an FDA review of BPA studies that concluded that the research did “not indicate a safety concern at the current exposure level for infants or adults” and that “FDA sees no reason at this time to ban or otherwise restrict uses now authorized”.
Rep. Al Wynn, the Chairman of the Subcommittee on Environment and Hazardous Materials, echoed Dingell”™s concerns about exposing both adults and infants to a “potentially dangerous substance”.
On February 6, 2008 the Congressional investigation into bisphenol A took a new turn when they started examining the Washington DC based regulatory and scientific consultant firm, the Weinberg Group. Chairman Dingell, in the committee press release, stated that “[t]he tactics apparently employed by the Weinberg Group raise serious questions about whether science is for sale at these consulting groups, and the effect this faulty science might have on the public health”. Chairman Stupak said that “[f]rom previous correspondence, it appears that the Weinberg Group prides itself on using its ”˜scientific capital”™ to create an outcome desired by corporate clients. It is not at all clear whether such outcomes are supported by the real scientific evidence. Our Committee will be interested to see whether the proponents of Bisphenol A have paid to engineer science that reaches pre-determined conclusions”.
The congressional committee was interested in the implications of a 2003 letter from the Weinberg Group to DuPont chemicals about how the group could create the science to benefit DuPont in its battle with EPA and fight a class action over one of its products.
The Weinberg Group on manufacturing consensus science
DuPont is currently the world’s second largest chemical company in terms of market capitalization and fourth in revenue, with its stock price a component of the Dow Jones Industrial Average. On July 4, 2004 EPA filed suit against Dupont alleging that the company had created a “substantial risk to injury to health or the environment” from the synthetic chemical, perfluorooctanoic acid (PFOA), an industrial surfactant used primarily in manufacturing Teflon. EPA also alleged that DuPont had withheld for more than twenty years evidence that PFOA could cross the placental barrier. The EPA action resulted in a class action lawsuit by thousands of people who lived in the vicinity of DuPont”™s Washington plant, alleging the company had poisoned their air and water with harmful levels of PFOA. In 2004 and 2005 JP Morgan Worldwide Securities Services issued reports for Dupont shareholders warning that the company was facing potential EPA fines of more than $300 million, with a liability bill of $150 – $800 million. DuPont also faced a risk to its $1.23 billion fluoropolymers and telomers business.
In early 2003 when EPA first began investigating PFOA it negotiated with producers of the chemical to provide missing information on the chemical through enforceable agreements of necessary. DuPont obliged with a great deal of information, including an April 29, 2003 letter from The Weinberg Group. This letter, sent by P. Terrence Gaffney, vice president of the Weinberg Group”™s Product Defence section was addressed to Jane Brooks, a vice president of Special Initiatives at Dupont. This letter was found in the EPA”™s files by Paul Thacker who wrote a subsequent article about it in Environmental Science and Technology on February 22, 2006. The letter laid out a proposal that the Weinberg Group made to Dupont about dealing with both the EPA draft health risk assessment of PFOA and the pending civil-action lawsuit. This letter is a clear example of the sort of ”˜product defence”™ expertise an industry can draw upon to subvert science in order to protect their corporate interests. David Michaels referred to the Weinberg letter as one of the best examples he had seen of what he called a common business strategy: to create scientific doubt in order to stave of lawsuits and regulatory action.
The Weinberg Group describes itself as “an international scientific and regulatory consulting firm that helps companies protect their product at every stage of its life. We help our clients improve manufacturing processes, clear regulatory hurdles, and defend products in the courts and the media”.
According to the letter, which reads very much as a sales-pitch to DuPont, the group “have successfully guided clients through myriad regulatory, litigation, and public relations challenges posed by those whose agenda is to grossly over regulate, extract settlements from, or otherwise damage the chemical manufacturing industry”.
The letter went on to suggest that if the Weinberg Group was hired by DuPont they would “harness, focus and involve the scientific and intellectual capital of our company with one goal in mind ”“ creating the outcome our client desires”. The letter continued: “The outcome of this process will result in the preparation of a multifaceted plan to take control of the ongoing risk assessment by the EPA, looming regulatory challenges, likely litigation, and almost certain medical monitoring hurtles. The primary focus of this endeavor is to strive to create the climate and conditions that will obviate, or at the very least, minimize ongoing litigation and contemplated regulation relating to PFOA. This would include the facilitating the publication of papers and articles dispelling the alleged nexis between PFOA and teratogenicity as well as other claimed harm. We would also lay the foundation for creating Daubert precedent to discourage additional lawsuits.”
The Weinberg Group then laid out a list of actions they would tackle on Dupont”™s behalf. A few of those actions are as follows:
”¢ “develop “blue ribbon panels” of thought leaders on issues related to PFOA IN REGIONS WHERE MANUFACTURING PLANTS ARE LOCATED to create awareness of safety regarding PFOA in areas of likely litigation, and in particular where medical monitoring claims may be brought”.
”¢ begin to identify and retain leading scientists to consult on the range of issues involving PFOA so as to develop a premium expert panel and concurrently conflict out experts from consulting with plaintiffs.
”¢ reshape the debate by identifying the likely known health benefits of PFOA exposure by analysing existing data, and/or constructing a study to establish not only that PFOA is safe over a range of serum concentration levels, but that it offers real health benefits (oxygen carrying capacity and prevention of CAD”. [coronary artery disease]
”¢ coordinate the publishing of white papers on PFOA, junk science and the limits of medical monitoring.
”¢ work with industry lobbyists to ensure they remain on message regarding the scientific issues related to PFOA.
”¢ provide the strategy to illustrate how epidemiological association has little or nothing to do with individual causation, and
”¢ begin to shape the Daubert standards in ways most beneficial to manufacturers.
The congressional investigation was also interested in a 2005 report the Weinberg Group wrote for the ACC (who had ”˜partnered”™ with NIEHS) on endocrine disruptor chemicals, which includes pthalates and BPA. The 2005 report, titled, State of the Science and Policy for Endocrine Disruption, called the risks of these chemicals “hypothetical” and that existing regulations for these chemicals were sufficient. The authors made the claim that “[c]onsiderable scientific effort to date has produced a consensus” that (1) there was no evidence humans were harmed from environmental levels of the chemicals; that (2) there was no convincing evidence of a growing health issue; that (3) there was some evidence that some wildlife populations have been affected at high levels of exposure; and that (4) there was no scientific rationale for classifying or labelling these substances as endocrine disruptors. They concluded in part that,”[t]here is no need to classify, label or ban substances based on a nebulous and varied endocrine mode of action”.
Discussion of the above Weinberg proposal points
If the basic aim of peer review is to maintain or maximize the quality of work in a field of research through an objective review of that work by the author”™s peers, then the Weinberg Group letter clearly illustrates that the traditional role of peer review is under threat. Peer review requires an objective evaluation of works that will be able to detect weaknesses and errors and hopefully direct the author of the work to correct these. However the ability of peer reviewers to detect bias can be a weakness of the process. The quality of the process very much depends on how carefully the reviewers are selected as reviewers would naturally be more accepting of works that support their own viewpoints and more critical of those that contradict them. If a scientific paper is funded by an industry and written with the sole aim to preordain the safety of that industry”™s product, such as PFOA, how would an objective reviewer handle this fundamental bias and conflict of interest? For such ”˜manufactured science”™ would entities like the Weinberg group dare subject their product to an open and objective peer review process or leave it to “a premium expert panel” that they have hand-picked to do their bidding?
As for the point about reshaping debate by identifying likely health benefits of the chemical, David Ozonoff, Chairman Emeritus of the Department of Environmental Health at Boston University and member of the EPA”™s Science Advisory Board (SAB) on PFOA, called it “fantasy thinking” . Ozonoff saw quite the opposite being the case with research showing there may be an increase in cardiovascular disease. Ozonoff considered the Weinberg proposal as simply a “manufacturing doubt strategy”. He also warned that any scientist getting into the area must address must address this sort of narrative. This warning also applied to any reviewer who might be asked to peer review such a paper.
The mention of the so called “Daubert standards” as being “beneficial to manufacturers” is a further example of how peer review (in a legal sense) has been usurped by a legal strategy that acts to block scientific information inimical to industry interests in product liability and toxic tort cases.