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April 14, 2008

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Integrity in Science Watch

Week of 04/14/2008

EPA Sued over Pesticide Approval

A coalition of environmental and farm worker groups sued the Environmental Protection Agency after the agency approved the sale of four organophosphate pesticides that the groups say pose unacceptable risks to the environment and human health. The lawsuit alleged that the agency violated the Federal Insecticide, Fungicide, and Rodenticide Act and the Endangered Species Act when it decided in 2006 to allow the continued use of the chemicals, which are sprayed on fruits and vegetables in California. California has classified one of the pesticides as a cancer-causing substance, another as an air pollutant, and a third has been banned or severely restricted in 13 countries. The approval came despite a letter from unions representing EPA scientists urging Administrator Stephen Johnson to reject the applications. “Our colleagues in the Pesticide Program feel besieged by political pressure exerted by Agency officials closely aligned with the pesticide industry,” the letter stated. “We are concerned that the agency has lost sight of its regulatory responsibility in trying to reach consensus with those that it regulates, and the result is that the integrity of the science upon which Agency decisions are based has been compromised.”

According to Earthjustice the environmental law firm that represents the coalition, the substances have severe impacts on birds, fish, honeybees, threatened, and endangered species and have carcinogenic and neurotoxic effects on human health. The class of organophosphate pesticides is derived from nerve gas poisons developed during World War II. Clinton-era efforts to ban the pesticides were reversed by the Bush Administration. The EPA approved the four substances as part of a cumulative risk assessment of 20 organophosphate pesticides in 2006, in which the Agency concluded that with the adoption of risk mitigation measures, they posed no significant cumulative risk. The EPA and CropLife America, the trade association representing manufacturers of organophosphate and other pesticides, could not be reached for comment on the lawsuit.

FDA Warns GSK on Failure to Report Data

GlaxoSmithKline received a warning from the Food and Drug Administration last week for failing to file regular reports about clinical trials on Avandia, a widely prescribed diabetes drug. The FDA called Glaxo’s failure to provide reports a serious violation and urged the drug company to take steps to prevent future violations. The reports, which are required by law and used to catch potential safety issues, were discovered by the FDA in Glaxo’s records. The FDA inspection found that between 2001 and 2007, the company did not inform the agency about the start of nine clinical trials and failed to provide progress updates on another dozen studies.

Avandia was linked to increased risk of heart attack in a New England Journal of Medicine study and now carries a “black-box” warning on its label. Once the highest-selling diabetes drug in the world, Avandia’s sales have plummeted since the FDA ordered a warning label on the drug in November of last year.

UNC Renames Public Health School after CEO Gift

The University of North Carolina School of Public Health will soon be known as the Dennis and Joan Gillings School of Global Public Health because of a $50 million donation to the school by Quintiles Transnational Corp. CEO, Dennis Gillings. Quintiles Transnational, a research contract and services provider for pharmaceutical companies, has annual revenue of $2 billion. Gillings, who announced the gift last year, was a professor in the UNC department of biostatistics for 17 years before he founded Quintiles Transnational in 1982. Currently, he serves on the advisory council of the school of public health. Gillings has previously given over $3 million to the university.

While UNC officials have praised the Gillings’ charitable gifts, some local professors have voiced concern. Steve Wing, an associate professor of epidemiology at the UNC School of Public Health, and Cat Warren, an associate professor in department of English at North Carolina State University, wrote in the Raleigh News Observer last month that the Gillings donation to the school could extend corporate influence over the school of public health. The editorial also pointed out that the school has recently developed relationships with executives of Nestle, McDonald’s, PepsiCo, and Kraft Foods. “If universities are skewed more toward the agenda of for-profit companies, they will be increasingly unable to promote public welfare when it conflicts with industry’s bottom line,” the professors wrote.

In the week following the professors’ editorial, Barbara K. Rimer, dean of the UNC School of Public Health responded with her own editorial in the News Observer. “The Gillingses’ gift was subjected to great scrutiny within the university to assure that it conforms to university policies and principles, including academic integrity and autonomy. Their $50 million pledge is a personal not a corporate gift,” Rimer wrote. The school of public health’s director of communications, Ramona Dubose, added, “The university does indeed have regulations designed to protect the integrity of our research, no matter what the source of funding. We do this in a variety of ways through agreements that stipulate our freedom from constraints in publishing results and disclosure forms that disclose potential conflicts.” The university’s policy on research relationships between the school and private entities is also available online.

Study Suggests Ending Cancer Trials Early Could be Unsafe

A study published in the Annals of Oncology suggests new cancer drugs' effectiveness could be exaggerated when clinical trials are halted early. Trials are discontinued early if the drug appears to be unsafe, provides no benefit, or is so beneficial that denying access to the treatment would be unethical. Giovanni Apolone, author of the study, told the Guardian that pharmaceutical companies could be ending successful trials prematurely in order to gain “quicker access to the market.” Halting trials too early because of patient benefit could lead to incomplete and imprecise information about the drug. Potential adverse (or additional beneficial) impacts of the medications could also go undetected if the trials are shortened. The authors found that 25 cancer trials were stopped early between 1997 and 2007. For 75 percent of those trials, the data gained from them was used to apply for FDA or European Medicine Agency approval.

Paul Meuller, an associate professor of medicine at the Mayo Clinic, warned that such data could be unreliable and lead to dangerous decisions by government agencies. “Decisions are being made on some fairly shaky evidence,” Mueller told the Wall Street Journal Health Blog. While Mueller noted that halting trials early and bringing drugs to the market sooner could benefit the industry and patients' health, he said, “Trials should be carried out long enough in order to obtain data about outcomes important to doctors and patients.”

Odds and Ends

House Oversight and Government Reform Committee Chairman Henry Waxman (D_CA) last week issued a subpoena to the EPA demanding unredacted copies of documents concerning the agency’s refusal to grant California a Clean Air Act waiver. The documents pertain to communications between the agency and the White House prior to the agency’s decision to deny the waiver, which would have allowed California to proceed with policies to curb greenhouse gases. . . . The Food and Drug Administration held two days of hearings last week on possible agency guidelines designed to regulate embryonic stem-cell therapies. The FDA continues to face pressure to approve clinical trials of stem-cell-derived drugs from biotech companies.

Cheers and Jeers

  • Cheer to Lauran Neergaard of the Associated Press for noting that Andrei Gudkov of the Roswell Park Cancer Institute also founded Cleveland Biolabs Inc., a drug company currently working on a new medical treatment that prevents radiation damage during cancer treatment and biodefense.
  • Jeer to Barnaby J. Feder of the New York Times for quoting Mary F. Hazinski, spokesman of the American Heart Association (AHA) about the benefits of home defibrillators without disclosing that last year the AHA received money from Zoll Medical, Medtronic, and Philips, three of the largest manufacturers of home defibrillators. Hazinski extolled the usefulness of home defibrillators for some consumers despite the results of a long-awaited, government-supported clinical trial published this month in the New England Journal of Medicine, which suggested otherwise.