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October 9, 2007

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Integrity in Science Watch

Week of 10/09/2007

Fishing Group Funds Omega-3 Frenzy

The fishing industry's main trade association financed the publicity campaign promoting controversial new recommendations that pregnant women eat more fish. Guidelines released last week by the industry-supported Healthy Mothers, Healthy Babies Coalition (HMHB) said women should eat at least 12 ounces of fish weekly to ensure adequate omega-3 fatty acids for the developing fetus. Those recommendations contradict Food and Drug Administration advisories that were issued in 2001 and 2004, which warned pregnant and breastfeeding women to avoid excessive consumption of seafood, especially large ocean-going species like swordfish, shark, and king mackerel that carry high levels of mercury. The FDA, the National Institutes of Health and the Centers for Disease Control and Prevention, which are members of the HMHB coalition, were not notified about the new report and dissociated themselves from its findings, according to National Public Radio.

The $60,000 grant from the National Fisheries Institute funded HMHB's website and accompanying press relations, which succeeded in landing a front page "scoop" in the Washington Post. Neither the website nor the Post noted the group's industry ties, which only came to light when a reporter raised the issue at subsequent press conference. A spokeswoman for HMHB said the group asked NFI for the grant at the request of its partner, the 14-member Maternal Nutrition Group, which authored the findings. The HMHB spokeswoman also confirmed that not all members of the coalition back its new recommendations.

The HMHB Maternal Nutrition Group's recommendations were based on several recent studies, including an Institute of Medicine report written by a panel that included David C. Bellinger, who has received funding from the fishing industry. The major study cited by the new recommendation, which was published in The Lancet earlier this year, has been harshly criticized for its "deeply flawed analysis" by government scientists writing in a private capacity. Neither the press coverage nor the study noted these criticisms. Another letter to The Lancet from public health scientists pointed out that pregnant and nursing women can obtain adequate Omega-3s by eating fish species that contain less dangerous levels of mercury contamination.

FDA Foundation Seeks Fix for Innovation Slowdown

Can the government help food and drug companies develop better products more quickly? That's the goal of the Reagan-Udall Foundation, a little noticed non-profit that was created under the Food and Drug Administration reform bill that President Bush signed into law last month. The new institute, which will accept both public and private funds, is empowered to research ways to "modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety." The Foundation was created in response to the 2004 Critical Path report, which revealed a sharp decline in medically significant new products moving through the FDA.

The Foundation, which will be heavily influenced by industry, merits close scrutiny since it could play a major role in shaping future FDA regulatory policy. It will award grants to the private sector, universities and non-profits to develop new tools for evaluating product applications that influence biomarkers, for instance, or new types of food additives. It will also try to develop new tools for evaluating drugs whose dangers only affect small groups. Industry has been given four seats on its board, which also includes the heads of the FDA, the National Institutes of Health, the Centers for Disease Control and Prevention and the Agency for Healthcare Research and Quality. The FDA is seeking nominations for the board's other slots, which include four at-large members with relevant expertise, three members from academia, two from patient or consumer groups, and one health care provider representative. Nominations must be submitted to Reagan-Udall-Board@FDA.HHS.GOV by October 15th.

Tobacco Firms Hired Experts in NIH-Funded Cancer Trial

Tobacco companies hired two researchers involved in the National Institutes of Health's $200 million trial testing whether routine CT scans of smokers' and former smokers' chests can identify lung cancer in its earliest stages and save lives through early intervention, the Wall Street Journal reported (subscription required). The researchers were paid experts in civil suits brought by patients who want the tobacco industry to pay for the screenings. The issue came to light after protests by the Washington-based Lung Cancer Alliance, which supports screening. This patient advocacy group, the story notes, has received $100,000 from General Electric, which would profit from a massive expansion in cancer CT scans. The House Energy and Commerce Committee has launched an investigation into the conflicts of interest, and whether the researchers who designed the NIH study tilted its design in ways that would discourage mass screening.

The two researchers with ties to Big Tobacco are University of California Los Angeles radiologist Denise Aberle, who testified in a 2003 case in Louisiana on behalf of American Tobacco Co., and Dartmouth College radiologist William Black, who testified in a New York case for Philip Morris. Aberle, one of the national leaders of the NIH trial, said UCLA got the money from her testimony and Black subsequently ended his relationship with tobacco companies.

NIH defended using scientists with previous ties to the tobacco industry. "Service as an expert witness, presenting independent analyses based on published medical literature, is a commonly accepted activity for physicians, researchers, and other experts and in the instance of the specific circumstances described did not violate the required disclosure guidelines of the organizations involved," NCI director John Niederhuber told the Lung Cancer Alliance in a letter. And a spokesman told the Journal that NIH has no way of knowing whether any other investigators in the 30-center study have financial ties to tobacco or scanning companies because it does not examine such potential conflicts.

Congress, Scientists Seek New Owl Recovery Plan

The Center for Science in the Public Interest has joined numerous scientists, environmental groups and officials on Capitol Hill in calling on the Fish and Wildlife Service to draft a new recovery plan for the Northern Spotted Owl. The protests point to "the influence of political appointees with ties to extractive industries" in writing a plan that fails to provide sufficient habitat for the remaining owls. The FWS received more than 80,000 public comments on the plan, including from two of the scientists on the recovery team-- Dominick DellaSala of the National Center for Conservation Science and Policy and Timothy Cullinan of Audubon Washington, who wrote that political interference "resulted in a recovery plan that is not a product of the best available science but was based on preconceived outcomes." Twenty-three Democratic Congresspersons and 113 scientists have also written to Interior Secretary Dirk Kempthorne asking that he withdraw the draft plan and reissue a scientifically credible plan.

White House Withdraws Controversial Bulletin

The White House has withdrawn a controversial bulletin that sought to standardize the way in which the government conducts risk assessments after months of prodding by the National Academy of Sciences (NAS), U.S. Senators, and environmental groups. The bulletin, which sought to impose a single assessment structure devised by the White House's Office of Management and Budget on the variety of government agencies that conduct risk assessments, underwent NAS review last fall. The review called for the bulletin's withdrawal and called its one-size-fits-all approach to assessing the risks to human health, safety, and the environment of various activities and chemical exposures "fundamentally flawed." Senators Jeff Bingaman (D-NM) and Joe Lieberman (I-CT) had asked OMB to comply with the NAS' directive. The final memo released last month contained "not very significant" changes, according to the nonprofit government watchdog group OMB Watch.

Odds and Ends

After a one-week delay triggered by scientists' protests, the Environmental Protection Agency late last week approved a one-year registration for the soil fumigant iodomethane, marketed by Arysta Life Sciences, under "highly restrictive" conditions. . . The Government Accountability Office slams the EPA for its flawed cleanup of asbestos processing factories in the Pacific Northwest and for failing to warn homeowners about the public health danger. . . Six Democratic senators, citing the scientific consensus that the U.S. "must reduce total current U.S. emissions by 80 percent by 2050," ask Senators Joseph I. Lieberman (I-CT) and John W. Warner (R-VA) to include strict greenhouse gas limits in soon-to-be-introduced climate change legislation.

Cheers and Jeers

  • Cheer to Adam Liptak of the New York Times for exposing Mississippi doctor Jay T. Segarra's paid testimony on both sides of a case involving thousands of fraudulent diagnoses of asbestosis and silicosis by medical screening companies. Liptak reported that while Segarra provided the expert testimony that Texas federal Judge Janis Black relied on to crack down on the fraud, he also made over $10 million diagnosing the illnesses for these same screening companies.
  • Jeer to ABC News and NBC's Today Show for failing to report the industry funding of the publicity campaign surrounding the Healthy Mothers, Healthy Babies Coalition recommendations urging greater fish consumption for pregnant women, even though the issue came up at the press conference where the findings were unveiled (and a cheer to NPR for reporting it).