NIH Sacks Contractor Due to Conflict of Interest

According to the website of Sciences International (SI), a Virginia-based consulting firm, “Reproductive and endocrine toxicology is one of the most active fields in environmental health, with considerable regulatory activity in the last decade.” SI promises to provide for its clients, among other services, “independent evaluation and interpretation of study findings.”

For eight years, Sciences International has been under contract by the National Institutes of Health (NIH) to provide what the NIH calls “administrative and logistical support” to its experts in the Center for the Evaluation of Risks to Human Reproduction (CERHR). Now, however, the so-called independence of SI’s evaluations has come under close scrutiny after it was revealed that the consulting firm has had significant business ties to a wide range of companies in the chemical industry including companies that manufacture chemicals under their review. The Washington Post also reported that all but two employees at the CEHRH worked directly for SI.

Many of the revelations about SI’s industry connections and its potential for conflicts of interest come courtesy of Environmental Working Group (EWG), a public watchdog and nonprofit research organization based in Washington, D.C. In February, EWG reported, “A federal agency that evaluates the causes of birth defects and other reproductive problems is run by a consulting firm with ties to companies that make chemicals the agency is charged with reviewing EWG found that Sciences International has collaborated with Dow Chemical Co., a major manufacturer of a widely used industrial chemical the agency will evaluate next week, and has also worked for the tobacco giant R.J. Reynolds.”

At the center of the controversy is a chemical known as bisphenol-A (BPA), an ingredient in plastic and resin used to line metal food and drink cans. To date, the federal government has not established any safety standards regulating the amount of BPA that can be used in canned foods. However, many scientists suspect that BPA may be dangerous to human reproductive systems. SI has had ties to both Dow Chemical and BASF, two companies that have manufactured BPA.

According to EWG, “More than 100 peer-reviewed studies have found BPA to be toxic at low doses, some similar to those found in people, yet not a single regulatory agency has updated safety standards to reflect this low-dose toxicity.” They also note that “BPA is associated with a number of health problems and diseases that are on the rise in the U.S. population, including breast and prostate cancer and infertility. Given widespread human exposure to BPA and hundreds of studies showing its adverse effects, the FDA and EPA must act quickly to revise safe levels for BPA exposure based on the latest science on the low-dose toxicity of the chemical.”

EWG also claims, “Of all foods tested, chicken soup, infant formula, and ravioli had BPA levels of highest concern. Just one to three servings of foods with these concentrations could expose a woman or child to BPA at levels that caused serious adverse effects in animal tests. For one in 10 cans of all food tested, and one in three cans of infant formula, a single serving contained enough BPA to expose a woman or infant to BPA levels more than 200 times the government’s traditional safe level of exposure for industrial chemicals.”

In a letter to David Schwartz, the director of toxicology of the National Institute of Environmental Health Sciences, Richard Wiles, EWG’s executive director, wrote, “The arrangement between CERHR and SI raises serious ethical questions that demand immediate disclosure of financial and research ties to chemical manufacturers and other industries that make or use substances under review by the CERHR. Questions about the objectivity and adequacy of this review process and the reviewers must be resolved before a final decision on BPA is reached.”

In light of the revelations about SI’s industry ties, the NIH has decided to re-evaluate all of SI’s research about BPA, which is only one of 20 chemicals under SI’s review at the NIH. EWG believes that the government should review the work done on all 20 of the chemicals. An additional expert panel will be held in May to reassess the research about BPA.

For its part, the National Toxicology Program (NTP), which oversees the CERHR, said, “The National Toxicology Program (NTP) is committed to safeguarding the integrity of its science, including reviews by its Center for the Evaluation of Risks to Human Reproduction (CERHR), which is currently considering the risk to human health of bisphenol-A (BPA). Recently, concerns were raised regarding potential business ties that SI or its employees may have. Although SI does not have responsibilities that would directly influence the outcome of CERHR decisions regarding BPA, because of concerns about potential conflicts of interest, the NTP has implemented a thorough review of all aspects of the SI contract and the nature of services provided by SI to the CERHR.”

The NTP notably added the following: “Without prejudging the outcome of the review, the NTP is especially concerned that SI has seemingly implied in its promotional material that its role as a Federal Government Contractor would be advantageous to regulated industries. As far as the NTP is concerned, such an implication is inappropriate, and it is understandable how such statements would lead to concerns about potential conflicts of interest.”

The NIH also asked SI to conduct an internal review of its program, and SI has reported that they have not found any conflicts of interest. (It did admit, however, that in three separate cases, SI was receiving consulting fees from industry associations with direct ties to the products it was reviewing for the government.) However, many in the science world are not convinced of SI’s innocence. “SI has been paid millions in taxpayer dollars over the past eight years to determine whether bisphenol-A (BPA) and other important commercial chemicals harm human reproduction and development,” notes EWG. “Client lists from SI’s website indicate that the company was simultaneously working for the very companies that use and produce BPA and other chemicals under review. SI replied in writing to NIH that its own internal investigation found no conflict of interests over the issue of BPA. However, SI still has not provided a complete client list or details of their employment by the chemical industry.”

Said EWG executive director Wiles, “It’s bad enough the Bush administration outsourced research into the effects chemicals could have on our children to a company that works for the chemical industry. It’s even worse when they allow the same companies to decide whether these arrangements present a conflict of interest. It is time for an independent investigation of contractor conflicts of interest at NIH.”