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dose of controversy; Instead, Carolyn Aldige of the Cancer Research and Prevention Foundation told a Food and Drug Administration advisory committee she had no financial ties to OSI Pharmaceuticals, the Melville company that makes Tarceva. But Aldige now says her foundation had received funding from OSI and its marketing partner for Tarceva, Genentech. Every year, drug companies give millions of dollars to various organizations, some of which voice public support for their products. That practice adds another layer to a stack of concerns about potential conflicts posed by the FDA drug approval process. Aldige testified at a Sept. 13, 2005, FDA meeting in Bethesda, Md., on Tarceva's behalf; the FDA panel also considered Abbott Laboratories' prostate cancer drug Xinlay that day. "I do want to mention I have absolutely no financial connection with either of the sponsors, either of the companies that sponsor these drugs, and I paid my own way to be here, even though the gas was pretty expensive," Aldige told the FDA panel, according to a transcript. But when Newsday questioned Aldige, she said OSI began contributing to her Alexandria, Va., foundation four years ago. She said she didn't think a request from the panel chairwoman that speakers reveal financial ties to drug companies applied to OSI's contributions. Aldige said OSI has given her foundation "$35,000 to $75,000 each year" in educational grants and contributions. The foundation's 2006 annual report states it received at least $75,000 in "lifetime" contributions from OSI. "I do not see it as a conflict," Aldige said. "I think pancreatic cancer patients have so little. These patients have absolutely no hope." Aldige was one of three advocacy group heads who urged the FDA to approve Tarceva - a drug already approved for lung cancer - to help fight pancreatic cancer. OSI has contributed to all three advocacy groups. Although the FDA asks speakers at public hearings to reveal ties to drug companies, it has no authority to compel disclosure. "The disclosure issue seems to be a no-brainer," said Thomas Murray, president of The Hastings Center, a Garrison, N.Y., bioethics research institute. "If you [representatives of advocacy groups] are drawing a salary from an organization that draws a significant amount of dollars from a company that has an interest in a drug, you should disclose it." OSI's quest to win FDA approval for Tarceva for pancreatic cancer sparked controversy over its efficacy and cost and spurred questions from the FDA panel. Critics included cancer experts on the FDA committee - Dr. Bruce Cheson of Georgetown University Hospital and Dr. Silvana Martino of Angeles Clinic and Research Institute in Santa Monica, Calif. They questioned Tarceva's effects on pancreatic cancer, noting that clinical trials showed the pill added a median of only 12.5 days to the lives of patients with the disease. Tarceva prescriptions for lung cancer cost more than $2,000 a month in 2005; approval for pancreatic use would generate more revenue for OSI. Aldige and the heads of two other groups urged the FDA panel to recommend approval. Julie Fleshman, president of the Pancreatic Cancer Action Network, was the only one of the three to disclose OSI's funding. "I'm very conscious of those relationships," Fleshman told Newsday. "I want to make sure that the patients and public know everything we do is unbiased." The representative of the third group, Selma Schimmel, chief executive of Vital Options International, a not-for-profit organization in Studio City, Calif., told the FDA panel she had no financial links to OSI. In fact, Vital Options had received an OSI grant to produce a radio show about cancer several months before the meeting. Schimmel told Newsday she had forgotten about the grant. She said she couldn't recall the amount but estimated it was about $12,500. Initially, when Newsday questioned Schimmel, she said Vital Options began receiving OSI grants, valued at $21,000 each, after she urged approval for Tarceva. She wouldn't say how many grants had been received but said there was no quid pro quo. "I do believe that transparency is important," Schimmel said. "I don't believe they [OSI] influenced me. It wouldn't help my organization." Gabriel Leung, president of OSI Oncology, a division of OSI Pharmaceuticals, said his company does not discourage recipients from disclosing grants. "I think none of us believe there is anything to hide," Leung said. Leung said OSI gives educational grants to help support various programs. He declined to disclose how much OSI has given Vital Options and the Cancer Research and Prevention Foundation or when the contributions began. Schimmel, who has survived bouts with breast cancer diagnosed in 1983, when she was 28 and, later, ovarian cancer, said that for many years, there were no new treatments for pancreatic cancer. She pointed out that some patients live months longer than the median of 12.5 days. Genentech also contributed to Schimmel's and Aldige's groups. Neither woman would reveal how much was contributed. A 2006 annual report from Aldige's foundation listed contributions received between July 1, 2005, and June 30, 2006, and also acknowledged "lifetime" contributions. The various lifetime contributions from Genentech totaled at least $185,000; the report stated a range for the value of funds received instead of specifying exact amounts. Ultimately, the FDA advisory panel voted 10-3 to recommend Tarceva for pancreatic cancer, and the FDA gave its approval. Recently, the FDA began tightening disclosure requirements for advisory committee members brought in from outside the agency - often from elite medical centers or universities - to help evaluate drugs. Committee members often have investments in drug companies or receive contracts or consulting fees from them. But the proposed rule changes do not deal with relationships between drug companies and advocacy groups. Dr. Gregory Reaman, a professor of pediatrics at the George Washington University School of Medicine in Washington, D.C., said he does not object to drug company grants but noted: "I think full disclosure to assess conflicts or potential conflicts is absolutely essential." Reaman served on the panel that recommended Tarceva for pancreatic cancer. He said he listens carefully to speakers' comments. "In general, I think the only reason that the committee invites and that the agency invites public comment is so that those comments are considered," he said. Pamela Haylock, a registered nurse and oncology consultant in Medina, Texas, also served on the FDA committee. She said drug company contributions should be disclosed. "I think most of them [advocacy groups] get some kind of funding from pharmaceuticals, " Haylock said. And Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said disclosure is essential. "We are in a complete and utter bog when it comes to conflict of interest," Caplan said. But Schimmel insists drug company contributions don't influence her and said if more disclosure is needed, then the FDA should take the lead. "This should
fall on the FDA if they want to revise the amount of contributions,"
Schimmel said. |