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May 29, 2007

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Integrity in Science Watch

Week of 05/29/2007

Consumer Groups Seek Avandia Panel without Industry Ties

In the wake of a new study showing the best-selling diabetes drug Avandia increased heart attack risk by 43 percent over other drugs used for glycemic control, a coalition of leading consumer groups has asked the Food and Drug Administration to exclude scientists with conflicts of interest from a panel that later this year will reconsider the drug’s safety. “By staffing the Avandia advisory committee with scientists from diverse specialties who are non-conflicted, you will send a message that the FDA cares about avoiding conflicts of interest and evaluating drugs on the basis of unbiased scientific findings,” the groups said in a letter to FDA commissioner Andrew von Eschenbach. Signers included the Center for Science in the Public Interest, Consumers Union, the Union of Concerned Scientists and six other consumer groupsbody

The FDA is under fire for failing to respond to earlier warnings that Avandia (rosiglitazone) increased the risk of heart attacks in people with Type 2 diabetes. A company analysis given the FDA in 2005 showed a 31 percent greater risk, the Associated Press reported. As early as 2000, John B. Buse, a University of North Carolina endocrinologist who is incoming president of the American Diabetes Association, sent a letter to the FDA about “a worrisome trend in cardiovascular deaths and severe adverse events,” according to the New York Times. Last week, Sen. Charles Grassley charged higher-ups at the FDA with blocking the black box warning that safety officials inside the agency wanted to put on the drug. They were told to await a company study that is at least two years away. “The office responsible for post marketing safety needs to have the ability to warn Americans when it thinks it needs to do so,” Grassley said.

The FDA reform bill passed by the Senate earlier this month did not include provisions for an independent safety department, full transparency on clinical trials, and a ban on conflicts of interest on advisory committees. The House is expected to take up FDA issues in June as part of the Prescription Drug User Fee Act reauthorization process.

Drug Industry Gifts Make Gastro-Conference Easier to Digest

More than 15,000 doctors visited Washington, D.C. last week to attend the largest ever gathering of gastrointestinal physicians. Integrity in Science Watch paid a visit.

As soon as each doctor walked onto the convention floor, they were handed purple-pill backpacks advertising Nexium from AstraZeneca. The Shire Pharmaceuticals’ booth offered weary physicians a park-like atmosphere complete with gently rolling grassy hills, stone paths, park benches, and free hot dogs. The Abbott booth contained a mini-movie theater. On every aisle, companies provided free slushies, gourmet espressos, coffee, tea, sweets, hot dogs, and fresh pretzels. They also offered beach towels, blankets, movies, free internet access, and, the most popular gift of all, a comfortable place to sit and chat with colleagues or the model-like sales representatives who prowled the convention floor.

Most of the doctors surveyed did not express concerns about the potential influence of the gifts. Some said they expect free knick-knacks at conferences, but would oppose them at schools or hospitals. Others said it was important for companies to promote themselves. Almost no one favored cutting out free gifts at physician conventions and offices, but perhaps that was because this informal survey only included doctors clutching blankets, towels, key chains, or pens.

The quietest space on the convention floor was the corner reserved for the small booths of patient advocacy groups, text book sellers, and scientific journals. “We don’t get any sponsorship from corporations for our meeting booths,” said Crohn’s & Colitis Foundation of America representative Laura Hitchens, eyeing the towering Fuji stereo sound system blaring a description of a colonoscopy camera. Thelma King Thiel of the Hepatitis Foundation says they wouldn’t say no if a company was to offer to fund their booths, but not many companies are interested in prevention, she said. – By Caroline Rodriguez

Stanford Sides with Nuns Against Exxon

In a case of biting the hand that feeds you, Stanford University will join a group of New Jersey nuns and other environmental groups supporting a stockholders resolution demanding that ExxonMobil reduce its global greenhouse gas emissions, reports the Oakland Tribune.

In its proxy statement, Exxon opposes the emission-trimming proposal by pointing to the $100 million it has already given to Stanford for energy and climate research. Advocate groups are applauding Stanford’s decision on the proxy vote, but still criticize its involvement with the oil industry. They accuse Exxon of using the school’s name to greenwash the oil giant’s support of scientists and organizations that downplay the risk of global warming.

Self-Censorship at Smithsonian

A former employee claims top officials at the Smithsonian Museum of Natural History toned down elements of last year’s climate change exhibit to avoid backlash from the Bush Administration, the Associated Press reported. The White House wasn’t behind the move, said Robert Sullivan, a 16-year Smithsonian veteran who quit last fall after top officials tried to reassign him. Rather “the obsession with getting the next allocation and appropriation was so intense that anything that might upset the Congress or the White House was being looked at very carefully," he said.

Odds and Ends

University of California students want details on the secret negotiations that led to British Petroleum’s massive $500 million grant to UCal-Berkeley for global warming research, the San Francisco Examiner reports . . . In a three-part series, the student-run Harvard Crimson examines technology transfer issues, including complaints from professors that the university’s new conflict-of-interest rules are interfering with their entrepreneurial activities.

Cheers and Jeers

  • Jeer: To the Wall Street Journal for failing to tell readers of an op-ed by Scott Gottlieb, former FDA deputy commissioner now at the American Enterprise Institute, that AEI takes financial contributions from the drug industry and former Merck chief executive Raymond V. Gilmartin sits on its board. The op-ed accused the New England Journal of Medicine of “journalistic malpractice” in publishing a study that suggested the diabetes drug Avandia, made by GlaxoSmithKline, increased the risk of heart attacks.
  • Cheer: To the Washington Post for telling readers of its consumer Q&A on Avandia that a quoted expert had no ties to GlaxoSmithKline, but was an official of the Endocrine Society, which includes Glaxo on its Corporate Liaison Board.