House Investigating FDA-EthicAd Link
The House Energy and Commerce committee last week launched an investigation into the Food and Drug Administration’s use of the non-profit EthicAd to develop its website for educating prescription drug consumers about direct-to-consumer advertising. Most of the professionals behind EthicAd, including executive director Michael Shaw of Shaw Science Partners, are involved in product marketing consulting for the pharmaceutical industry. "According to the Shaw Science Partners Web site, the company has worked on the launch of more than 30 drugs, including Procrit, whose DTC advertisements have been investigated by this Committee, and Rezulin, a drug that was removed from the market for safety problems," said the letter to the FDA from chairman John Dingell (D-MI) and Bart Stupak (D-MI). The committee also sent an information request to EthicAd, which shares the same address with Shaw Science Partners in Atlanta. The letters requested the FDA and EthicAd turn over all documents about the relationship between the FDA, EthicAd, and the pharmaceutical industry.
NIH Clamps Down on Emory after Nemeroff Scandal
The National Institutes of Health last week demanded Atlanta's Emory University provide "institutional assurance of compliance" with agency conflict-of-interest disclosure rules for every NIH grant it receives, the Wall Street Journal reported last week. NIH also stopped payments on a $9.3 million study of psychiatric medications at Emory after Sen. Charles Grassley (R-IA) revealed that lead researcher Charles Nemeroff had failed to tell Emory about receiving millions of dollars in drug industry payments while simultaneously running the government study. Universities that administer government grants are supposed to enforce the NIH's conflict-of-interest rules, but a recent Government Accountability Office study revealed that few universities take the obligation seriously and NIH does not monitor compliance.
In the wake of the NIH crackdown, Emory announced that Nemeroff will step down as principal investigator or co-investigator on all NIH grants to Emory. He also resigned as chair of the university's psychiatry department. "Failure to follow NIH standards on conflict of interest is very serious and NIH will take all appropriate action to ensure compliance," a spokesman for the agency said. NIH will soon release its congressionally-mandated guideline for how universities should disclose and police conflicts of interest among their NIH grant recipients.
NIH Panel on Hepatitis B Avoids Conflicts
A National Institutes of Health panel that will meet next week to recommend best treatment options for hepatitis B has no scientists with ties to industry, the conference coordinator confirmed. NIH's Office of Medical Applications of Research (OMAR)-almost unique among federal agencies-has a strict policy against including clinicians with conflicts of interest on its consensus panels. Moreover, the panel members will remain anonymous until the day of the conference so there is no opportunity for them to be lobbied, said Jennifer Croswell, the NIH coordinator of the conference. The meeting, which kicks off today, will release an assessment on Wednesday morning of what "we know and what we need to learn to effectively manage hepatitis B across diverse patient groups."
In evaluating members for the committee, OMAR deliberately avoids clinicians and scientists who have done work on the therapies being evaluated. They "don't want experts" with conflicts, Croswell explained. Rather, the agency looks for people with the skills necessary to evaluate evidence and then gives them briefing materials several months in advance so they can get up to speed on technical issues that may come up. Most of the speakers at the three-day event will have ties to the pharmaceutical industry, since firms have run most of the research into the various treatment options.
EPA Met with Industry Prior to Final Lead Rule
Industry lobbyists met with EPA officials prior to the agency's offering its new ambient air standard for lead, a known neurotoxin whose effects are especially harmful to children, OMB Watch reported. The new standard released last week lowered the allowable limit, but not as far as some environmentalists would like. The final ruling, made under court order, reduces the allowable lead level to 0.15 micrograms per cubic meter of air (µg/m3), one-tenth the longstanding 1.5 µg/m3 standard that had been harshly criticized by the agency’s Clean Air Scientific Advisory Committee. The new limit is near the upper end of the range that CASAC called for: 0.02 to 0.2 µg/m3.
After the CASAC report, lobbyists for industrial battery recyclers met with officials from the EPA, the White House Council on Environmental Quality, and other officials. That meeting took place in early October, according to Grist, the online environmental magazine. Also at the meeting was a representative of the Gradient Corporation, who distributed a slide show that said the scientific basis for the tightened standard was uncertain. Gradient is a consulting firm that has worked with numerous industries to downplay the health risks associated with exposures to bisphenol-A, tobacco, and other products.
Flawed Analysis Dictates Murrelet Move
The Fish and Wildlife Service agreed last week to review a petition seeking to remove the endangered status of a bird species that lives in old-growth forests in the Pacific Northwest, the journal Science reported. The agency's longstanding listing of the marbled murrelet as endangered was based on surveys showing that birds living in coastal forests of the Northwest coast are genetically distinct from those living in Canada. But an agency review in 2004 reached an opposite conclusion after Interior political appointee Julie MacDonald intervened and changed the recommendations of agency scientists, according to the Center for Biological Diversity's Noah Greenwald. The American Forest Resource Council, a timber industry lobbying group, wrote the petition that prompted the current review.
Odds and Ends
The House Oversight Committee has accused the Bush Administration of abusing executive privilege by refusing to release documents relating to the Environmental Protection Agency’s rulings on ozone pollution and greenhouse gas emissions.... A week after it was revealed that an institute directed by the chairman of a Food and Drug Administration advisory committee reviewing bisphenol-A took money from a deregulatory zealot, the FDA asked for public help in identifying what medical devices, drugs and other products contain BPA, the Wall Street Journal reported.... The EPA announced that a National Academy of Sciences panel will review its draft report on perchlorate, which the Washington Post has reported "will not set a drinking-water safety standard for perchlorate, a component of rocket fuel that has been linked to thyroid problems in pregnant women, newborns and young children across the nation".... Sen. Charles Grassley (R-IA) and Sen. Herb Kohl (D-WI) demanded that the non-profit Cardiovascular Research Foundation provide information about its financial relationships with device manufacturers and drug producers, the New York Times reported. The senators sent a similar letter to Columbia University, which has an affiliation with the Cardiovascular Research Foundation.... A new Government Accountability Office report on indoor mold found clear evidence of some adverse health effects and at least 15 areas where the science is inadequate. While three government agencies are investigating some of those areas, the research is not coordinated and advice by consumer agencies is inconsistent, the report noted…. Doctors, patients, and medical consumers could use a good course on health statistics, noted authors of an article in the journal Psychological Science in the Public Interest.
Cheers and Jeers
The Oct. 14 issue of Integrity in Science Watch incorrectly reported that a new EPA rule on hazardous waste was praised by the American Chemical Society. The ACS' Chemical and Engineering News reported that the move "had been sought by the chemical industry for more than a decade," but took no stand on the issue. We regret the error.