Integrity in Science Watch|
Week of 06/25/2007
Limits on FDA Advisory Committee Conflicts Clear Hurdle
The House Energy and Commerce Committee last week passed Food and Drug Administration reform legislation that will allow just one scientist with a conflict of interest to serve on any of the agency’s 30-plus advisory committees. In recent years, about a quarter of the scientists on FDA advisory panels have required conflict-of-interest waivers because they had financial ties either to the company whose product was up for review or its competitors. The Senate bill passed in June did not include the one-waiver limit. The Integrity in Science project at the Center for Science in the Public Interest (publisher of this newsletter) has been lobbying for a total ban on conflict-of-interest waivers.
Other measures in the legislation that will strengthen independent science at the agency include a requirement that companies register and post results for all clinical trials beyond early stage safety tests. The bill also calls for spending an additional $225 million over the next five years to beef up surveillance of drugs and devices once they reach the market. On the down side, the bill contains no limits on direct-to-consumer advertising, a victory for the pharmaceutical and advertising industry lobbyists. After the full House passes the measure, possibly with amendments, it will move to a House-Senate conference committee where differences like the competing conflict of interest provisions will be subject to intense behind-the-scenes lobbying.
Groups Challenge EPA’s Rollback of Toxics Reporting
More than 200 environmental and consumer groups last week called for legislation that would overturn the Environmental Protection Agency's new rule scaling back corporations' toxic chemical reporting requirements. Earlier this year, the EPA caved in to pressure from business lobbyists and the Small Business Administration by raising the threshold for Toxics Release Inventory reporting to 500 pounds for the most toxic compounds, such as mercury and PCBs, and 5,000 pounds for less toxic chemicals, from 100 pounds and 500 pounds, respectively. The rollbacks, billed as a means of reducing the regulatory burden for business, were protested by the EPA's own Science Advisory Board, which wrote to EPA Director Stephen L. Johnson that the changes could "hinder the advances of environmental research used to protect public health and the environment." A February Government Accountability Office (GAO) report warned the rule will curtail "information available to the public about dozens of toxic chemicals from thousands of facilities."
The rule changes have been protested by numerous Senators and Representatives, and the Senate will soon consider a bill that would force the EPA to resume requiring full reporting of toxic releases. Since toxic release reporting went into effect in 1988, corporate chemical releases have been reduced by nearly 60 percent. Observers largely credit citizen access to the data, which has generated community protests against the worst polluters and forced companies to voluntarily reduce emissions.
EPA's Proposed Ozone Standard Draws Immediate Protests
The Environmental Protection Agency last week unveiled a new ozone standard that the American Lung Association says "falls short of the goal recommended by [the EPA’s own] scientific experts." Moreover, the agency's willingness to take comments for another 90 days leaves the door open to "finalizing a do-nothing standard," the health group said. Efforts by agency scientists to issue a tighter standard have been hamstrung by industry lobbyists. Ozone is the primary component of photochemical smog. The EPA's outside science advisers unanimously agreed that levels should be reduced to between 0.06 and 0.07 parts per million. Recent research has shown that the new proposed level - 0.075 ppm, down from 0.085 ppm in place since 1997 - can be harmful to infants, asthma patients, and even healthy adults.
Hunters Bag Cooperative Conservation Agreement
Deputy Secretary of the Interior Lynn Scarlett, former chief executive of the libertarian Reason Foundation, last week unveiled the Cooperative Conservation Enhancement Act, which she billed as a way to provide funding for environmental protection through encouraging government partnerships with the private sector. The concept had been endorsed by the Sporting Conservation Council, an Interior Department advisory committee dominated by hunting groups. Eleven of twelve members on the Sporting Conservation Council, which is organized under the Federal Advisory Committee Act (FACA), belong to hunting groups, including the National Rifle Association, the Congressional Sportsmen's Foundation and Safari Club International, which has come under attack from the Humane Society for actively working to undermine the Endangered Species Act. FACA requires that advisory committees, even those that make policy recommendations, be balanced with regard to points of view.
Odds and Ends
A new report from the Government Accountability Office found that the Environmental Protection Agency ignored the advice of its outside experts when it developed methods for testing toxic dust from the World Trade center attacks in lower Manhattan, leaving local residents with misleading information about possible health risks.
Cheers and Jeers
- Cheer: to The Wall Street Journal for reporting (subscription required) on Friday that William Clark, a University of Washington in St. Louis researcher who has been paid at least $32,500 in consulting fees by the manufacturers of sirens and other emergency firefighting equipment, has been barred by Cook County Circuit Judge Robert E. Gordon from testifying in a lawsuit brought by firefighters over hearing losses. Integrity in Science Watch last February reported on the judge's order and Clark's failure to report his conflicts of interest in a study published in Ear & Hearing Journal.
- Jeer: to the article in the June issue of the AARP Bulletin highlighting Alzheimer’s Disease drugs under development. The story prominently quoted Sam Gandy, chair of the National Medical and Scientific Advisory Council of the Alzheimer's Association and director of the Farber Institute for Neurosciences in Philadelphia, unequivocally stating that disease-altering drugs will be available within three years with Neurochem's Alzhemed possibly approved as early as next year. What the 20 million-circulation paper didn't report is that the Farber Institute is one of many sites conducting final clinical trials on Neurochem's Alzhemed.