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September 5, 2006

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Integrity in Science Watch

Week of 09/05/2006

The Sound of Silence

The June 2005 issue of Ear & Hearing Journal published a study dismissing the link between firefighters' hearing loss and repeated exposure to loud, piercing sirens. One of the study's authors, William W. Clark of the Washington University School of Medicine in St. Louis, disclosed that he "provided consulting services for manufacturers of emergency firefighting equipment," but added "no external funding was received for this study." Now, documents turned up in a law suit filed by Chicago firefighters against Federal Signal Corp., which manufactures emergency equipment, show that lawyers for Federal Signal helped conceptualize the study and acquired the original data for Clark. Neither fact was disclosed in the study. The documents also showed Federal Signal lawyers paid Clark $9,300 in consulting fees while the study was underway and a $25,000 retainer for future testimony shortly after its publication. Attorneys for the firefighters have filed ethics complaints against Clark with the university and the editor of the journal. Neither Clark nor the journal editor returned CSPI's emails seeking comment.

Advocacy Group Finds FDA Drug and Device Panels Biased Toward Approval

The Food and Drug Administration's drug and device advisory panels almost always vote in favor of a product, even when members have concerns over its safety or effectiveness, a report released last week by the National Research Council for Women & Families concluded. The study looked at 11 committees from 1998 to 2005 that assessed controversial and innovative products - from gastrointestinal drugs to ophthalmic devices. Over the seven-year period, 79 percent of the 89 products reviewed received committee approval with 66 percent of the drugs and 75 percent of the devices receiving unanimous approval. The center attributed that history of favorable votes to the average panel harboring at least one individual with financial ties to the maker of the product which was under review. "[E]ven one committee member with a financial conflict of interest easily influences the votes of the entire committee," said Diana Zuckerman, executive director of the center. The group recommends the FDA "stop granting conflict-of-interest waivers for committee members, except under very restricted conditions," to restore faith in its advisory panels.

Clean Air Panel Overrides EPA; Calls for Stricter Standard on Ozone

An outside scientific expert panel last week unanimously overrode the Environmental Protection Agency staff's status quo recommendation on ozone. After a two-day review, the 23-member Clean Air Scientific Advisory Committee (CASAC) said new evidence showing adverse respiratory effects in sensitive groups such as children with asthma made the present ozone standard, which is 0.08 particles per million average over eight hours, obsolete. The panel is recommending an upper-end standard of 0.07 ppm, and a low-end range of 0.055 to 0.060 ppm. Environmental advocates are expecting that William Wehrum, acting Assistant Administrator for the EPA Office of Air and Radiation, who previously represented corporations on air pollution issues as a Washington attorney, will reject the recommendation and accept the staff report. CASAC will draft a formal letter submitting their consensus comments by September 18. EPA will issue a final report by the end of October.

Increasing User Fees Give Drug Makers Influence over FDA Drug-Review Process

The Food and Drug Administration wants to increase pharmaceutical companies' fees for underwriting FDA's costs for reviewing drug applications and for its facilities in the next year, which will increase the industry's influence over the agency's drug-review process, according to an article in the Wall Street Journal. Recent closed-door meetings between FDA and pharmaceutical officials, many of them former FDA employees, have proposed using higher fees for drug labeling and advertising oversight and beefed-up post-market drug safety monitoring. User fees for fiscal year 2004 generated $232 million, representing 53 percent of the total drug-review budget and a 25-fold increase since 1993. The large percentage of funding companies provide the FDA has translated into increased influence over the agency's regulatory operations. "There is no doubt that user fees give the industry leverage on setting the agency's priorities, because of the negotiating process," says Dr. Kessler, former head of the FDA, and now dean of the medical school at the University of California, San Francisco. "There are significant risks, especially when a growing percentage of the budget comes from user fees." For the next five-year agreement, which will begin Oct. 1, 2007, fees could cover 66 percent or more of the drug-review budget.

National Pork Board to Finance EPA's Study on Livestock Emissions

The swine industry and other commodity groups and livestock operations are funding a two-year study conducted by the Environmental Protection Agency which will determine which farms to target for emissions regulations, according to an article in the Des Moines Register. The agency is offering farmers protection from civil penalties, including fines or being sued by environmental groups, if they pay a fee anywhere from $200 to $100,000 to take part in the study. Businesses that fail to file emissions reports are liable to pay up to $27,500 a day. The EPA has signed on over 6,000 hog, poultry and dairy farms to take part in the $15.6 million study slated to run from April 2007 to March 2009. Environmental groups sued the EPA last year arguing the agreements are illegal and the lawsuit is still pending. "It means that all the neighbors that live next to these facilities have no hope of getting protected (until) at least 2010," when the EPA has had time to evaluate the study, said Kari Carney, rural community organizer with Iowa Citizens for Community Improvement.