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March 5, 2007

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Integrity in Science Watch

Week of 03/05/2007

BPA Decision to Rely on Industry Consultant's Report

The federal agency responsible for evaluating the reproductive hazards presented by bisphenol A (BPA) will base its decision on a 300-page report prepared by a consulting firm whose clients include the company that makes the chemical, according to an investigation by Environmental Working Group (EWG). The Center for the Evaluation of Risks to Human Reproduction (CERHR) is run by scientific and support staff at the National Institute of Environmental Health Sciences and Sciences International Inc. (SI), a firm with ties to BPA manufacturer Dow Chemical Co. The Los Angeles Times reported yesterday that SI's other clients include BASF, DuPont, Chevron, ExxonMobil, 3-M, Union Carbide, the National Association of Manufacturers, and 45 other manufacturing companies and industry groups.

BPA is a heavily used industrial chemical that is integral to the production of hard plastics and is found in the liners of metal food cans and in hard plastic containers. More than 200 animal studies show that BPA is toxic at very low doses, while the Centers for Disease Control has found BPA at levels that raise health concerns in 95 percent of people tested. The peer-reviewed science suggests that BPA may be contributing to increases in many human health problems, including breast cancer, prostate cancer and insulin resistance.

EWG wrote last week to Dr. David A. Schwartz, director of toxicology of the National Institute of Environmental Health Sciences, demanding that SI and its employees disclose all industry ties prior to a March 5 meeting at which a CERHR expert panel is scheduled to evaluate BPA's risks. Senate Environment and Public Works Committee Chairwoman Barbara Boxer (D-Calif.) and House Oversight and Government Reform Committee Chairman Henry Waxman (D-Calif.) also wrote Schwartz last week requesting a briefing on EWG's allegations.

EWG's investigation found:

  • Anthony Scialli, an SI employee who is the principal investigator of CERHR, in 2004 co-authored a scientific paper with a Dow Chemical employee. The study was funded by the European Chemical Industry Council.
  • In its BPA study, SI fails to disclose industry funding sources and author affiliations for two major studies by scientists who often work for the European Chemical Industry Council and the Society of the Plastics Industry, which have member companies that manufacture or use BPA.

Who Pays the FDA?

The 1992 Prescription Drug User Fee Act, which authorizes drug companies to pay user fees to the Food and Drug Administration for reviews of brand-name drugs, is up for renewal this year, and FDA reform advocates are hoping there will be an opportunity to reduce big pharma's influence on the agency by eliminating user fees. In an op-ed published in the Boston Globe last week, Harvard Medical School's Marcia Angell notes that the current system has created a "disproportionate emphasis" on getting brand-name drugs approved faster and weakened the agency's other public interest functions. Because the user fees only apply to brand name drugs, there is a backlog of 1,200 requests for generic drug reviews, according to the Associated Press.

Positive Study Outcomes Associated with Financial Conflicts of Interest

A study in the Journal of Bone and Joint Surgery has found that reports authored by orthopedists with a financial conflict of interest were more likely to have positive results than studies without such conflicts. The study also found reported conflicts of interest in more than 40 percent of the presentations it examined. Although authors Kanu Okike and Mininder S. Kocher of Harvard Medical School, Charles T. Mehlman of the University of Cincinnati College of Medicine, and Mohit Bhandari of Hamilton General Hospital did not receive any outside grants or funding for the study, the authors do have ties to commercial entities including DePuy, Smith and Nephew, Stryker, Zimmer, Medtronic, and Synthes. y

CEQ Agrees to Turn Over More Climate Documents

The House Oversight and Government Reform Committee appears to be close to getting its hands on documents related to possible political manipulation of climate change science that the committee has been seeking for months. In a Feb. 26 letter to White House Council on Environmental Quality (CEQ) Chairman James Connaughton, Committee Chairman Henry Waxman (D-Calif.) and ranking member Thomas Davis (R-Va.) revealed that CEQ aides had agreed to provide one box of documents a month to the committee. Meanwhile, the committee also postponed until March 19th a second hearing on the integrity of climate science that had been scheduled for March 1st.


  • Jeers: A USA Today article on a new caffeinated drink that claims to burn fat did not disclose that Jeffrey Blumberg is a consultant to the supplement industry and has done work for Pharmavite, Lifespring Home Nutrition, American Home Products, Hoffman-LaRoche Inc., Shaklee Corp., Bristol Myers-Squibb, MET-Rx, Natraceuticals, Odyssey Nutriceuticals Corp. and NutrAMed Inc.
  • Jeers: A Washington Post article on a study of common pain relievers called NSAIDs failed to disclose Elliot Antman's ties to a number of pharmaceutical companies, including NSAID manufacturers Pfizer and Merck.
  • Jeers: A New York Times piece on a study of anemia drugs failed to disclose that Dr. Eric P. Winer of the Dana-Farber Cancer Institute has received grants for clinical research from pharmaceutical companies including Genentech, Pfizer and GlaxoSmithKline.
  • Jeers: John Mellors, identified as a professor from the University of Pittsburgh, was quoted in a Wall Street Journal (subscription required) article on HIV drugs; not disclosed was that he has filed patents for HIV treatment methods and is a consultant with Merck and Gilead Sciences. Merck manufactures one of the new HIV medications discussed in the piece, and Gilead Sciences is currently testing a new HIV drug. The Wall Street Journal also quoted Daniel Kuritzes without disclosing that he has financial ties to Monogram Biosciences, Merck, Gilead Sciences and Pfizer.
  • Jeers: The Los Angeles Times did not disclose that Dr. John Glaspy, who was quoted in the story regarding the safety of the drug EPO, received grant support from EPO manufacturers Amgen and Johnson & Johnson.
  • Jeers: A Dallas-Fort Worth Star-Telegram op-ed mentioned several climate-change skeptics that have ties to the oil industry without disclosing those ties, including David R. Legates, Richard S. Lindzen, Patrick J. Michaels, and S. Fred Singer. Singer was also cited without disclosure in the Las Vegas Review-Journal, and Lindzen was cited without disclosure in a Flint Journal op-ed.

Odds and Ends

A California appeals court rules last week that the state's new embryonic stem cell research agency did not violate laws concerning conflict of interest rules, state spending, or the structure of ballot initiatives, the New York Times reported. The stem cell board is composed of officials of universities and other research facilities that could receive grants from the state research agency, but those board members are forbidden from voting for grants to their own institutions.