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September 22, 2008

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Integrity in Science Watch

Week of 09/22/2008

White House Wants to Put Perchlorate on Tap

The Bush administration this week will propose no change in the allowable level of perchlorate in drinking water, which leaves the standard 15 times greater than what Environmental Protection Agency staff scientists in 2002 said the science required, the Washington Post reported today. Anywhere from 16 million to 40 million Americans are exposed to dangerous levels of perchlorate, a rocket fuel component that affects the thyroid and causes brain development problems in fetuses and small children. Stricter regulation has been bogged down for most of this decade through political interference in scientific evaluation process orchestrated by the Pentagon and defense contractors, who would have to pay for any clean-up, environmentalists charge. The Post reported the latest proposal was heavily edited by the White House's Office of Management and Budget. "They have distorted the science to such an extent that they can justify not regulating" the chemical, Robert Zoeller, a University of Massachusetts thyroid hormone expert, told the newspaper.

Every scientific panel that has considered the issue has called for more stringent standards that the EPA, including a National Academy of Sciences panel that had several members with ties to the chemical industry. That 2005 risk assessment recommended exposure levels not exceed 1 to 6 parts per billion (ppb) in drinking water. The 2002 EPA staff report called for a 1 ppb standard. Massachusetts has set a 2 ppb standard; California allows 6 ppb. The EPA's proposed rule would leave the standard at 15 ppb limit on perchlorate exposure, but even that high level would still expose between 16,000 and 28,000 pregnant women and 900,000 to 2 million Americans to higher levels, the Post reported.

GAO: Science Falling Behind at EPA

The Environmental Protection Agency’s chemical risk assessment program is on the brink of collapse because of the agency’s failure to keep its listings up to date, Congress’ watchdog arm charged last week. Government Accountability Office (GAO) environment director John Stephenson told a House oversight panel that the Integrated Risk Information System (IRIS) is at “serious risk of becoming obsolete because of the inability for EPA to complete scientific analyses.” The IRIS database, which is used by numerous regulatory agencies in the U.S. and abroad, contains the EPA’s scientific conclusions about the risks to human health posed by exposure to about 540 chemicals, a small fraction of the thousands of chemicals now in commercial use. A coalition of four dozen environmental and public health organizations wrote EPA administrator Stephen Johnson opposing White House interference in the EPA's IRIS chemical assessment program.

The GAO’s latest report also cited the absence of transparency in the Office of Management and Budget’s latest changes to the IRIS risk assessment process, where OMB can now object to changes in the IRIS database without making its reviews available to the public (see perchlorate story above). Stephenson charged the lack of transparency eroded the credibility of the EPA assessments. The EPA completed just four chemical assessments in 2006 and 2007, and now has more than 70 chemicals pending review.

FDA Assailed for Choosing Biz-Backed BPA Studies

Public interest groups including the Center for Science in the Public Interest blasted the Food and Drug Administration at a public hearing last week for relying on industry-funded studies in its evaluation of the safety of bisphenol A, a chemical widely used in food packaging materials. The FDA’s BPA draft assessment, released earlier this month, alleged that the chemical was safe at exposure levels routinely experienced by the general population. The FDA assessment dismissed numerous independent and government-funded studies that suggest elevated risk from exposure to the chemical, and instead relied on two studies funded by an arm of the American Chemistry Council, a trade organization representing chemical manufacturers. Employees of SABIC Innovative Plastics and Dow Chemical, which manufacture BPA, coauthored the two studies. The studies’ lead author, Rochelle Tyl, of Research Triangle Institute in North Carolina, previously worked for the chemical industry and received research funding from the plastics industry.

Meanwhile, a study released on the eve of last week’s FDA hearing linked BPA to increased risk of diabetes and heart disease in humans. The study joins other recent human tissue research showing metabolic effects from BPA exposure in adults. Previous studies, including the two that informed the FDA’s conclusions, were conducted on rodents. Senator Charles Grassley (R-IA) demanded that FDA Commissioner Andrew von Eschenbach explain how the FDA decided which studies to use for its BPA risk assessment.

Journal Resection? Cancer Studies Go Unpublished

A study published in the journal Oncology last week found less than one in five cancer clinical trials registered in the government database ClinicalTrials.gov wind up in medical journals. Scott Ramsey and John Scoggins of the University of Washington warned that editorial bias against publishing negative results denies clinicians useful information since some of them may be using the ineffective regimens. “It is likely that many unpublished studies contain important information that could influence future research and present practice policy," the authors wrote. "Unpublished trials may have special importance in oncology, due to the toxicity and/or expense of many therapies.”

Bill Seeks to Overturn Open Access Publishing

Rep. John Conyers (D-MI), chair of the powerful House Judiciary Committee, has introduced legislation that would overturn a National Institutes of Health policy that requires government-funded studies be made publicly available a year after appearing in proprietary academic journals. According to the journal Science (subscription required), compliance has risen to 56 percent of all NIH-funded papers since the House made public access with a 12-month time lag mandatory earlier this year. Attorney Jonathan Band, representing the American Library Association, told the committee last week that the Conyers proposal would “limit a lot of what the federal government can do" in terms of promoting open access. The legislation is not expected to go anywhere this year.

Odds and Ends

A bill to ban the use of asbestos in all products in the U.S. was referred to the House Energy and Commerce Committee last week. . . . Officials at the U.S. Fish and Wildlife Service said they will rescind efforts to end gray wolf protection in Greater Yellowstone and the Northern Rockies. A federal judge recently issued an injunction reinstating Endangered Species Act protections for the wolves. . . . The Food and Drug Administration opened a public comment period on new rules governing genetic engineering of animals for food, drugs or medical devices. Gregory Jaffe of the Center for Science in the Public Interest warned that the new rules won’t “protect humans and the environment from all the potential risks that a genetically engineered animal may pose” and he urged that the scientific safety data be made available to the public before products are approved. . . . The Lancet has retracted a research paper by Austrian scientists who claimed to have cured 38 out of 42 women of stress incontinence using stem cell therapy after an Austrian government agency found serious ethical and procedural flaws in the clinical trial, the British Medical Journal reports . . . . The National Institute of Mental Health abandoned its test of chelation therapy for autism, claiming the money would be better used testing other potential therapies for autism and related disorders, the Washington Post reported. . . . A congressional hearing began investigating the issue of pharmaceuticals in drinking water last week. The problem has been subject of an ongoing Associated Press investigation that last week reported that “hospitals and long-term-care centers intentionally discard an estimated 250 million pounds a year of unused pharmaceuticals and tainted packaging — and much of those drugs also go directly down drains toward water supplies.”

Cheers and Jeers

  • Jeer to the New York Times for failing to disclose the oil industry financial ties of Robert Hahn, who wrote an op-ed commentary entitled “Save the Environment: Drill, Baby, Drill” in the September 15th edition. Hahn is executive director of the Reg-Markets Center at the American Enterprise Institute, which receives funding from ExxonMobil and GM.

  • Cheer to Mike Stobbe of the Associated Press for reporting the financial ties to General Electric of C. Daniel Johnson of the Mayo Clinic, who was lead researcher for a study published in the New England Journal of Medicine last week that showed virtual colonoscopy using CT scanning machines, which GE manufactures, was just as effective as regular colonoscopy for detecting colon polyps that can lead to cancer.

  • Jeer to Judith Graham of the Chicago Tribune for failing to note Johnson’s ties to GE in her story on the colon cancer screening study.

  • Jeer to Liz Szabo of USAToday, who quoted Harvard Medical School emeritus professor Robert Fletcher touting the availability of new and better colon cancer screening tests, for failing to note that Fletcher is a financial consultant to Exact Sciences, which is seeking Food and Drug Administration approval for a stool DNA colon cancer screening test. Fletcher's ties to Exact Sciences were revealed in an NEJM editorial.