Physician Ethics, Actions at Odds
A nationwide survey of more than 1600 practicing physicians found a sharp divergence between the ethics of the profession and actual medical practice. Well over 90 percent of doctors agreed they should report significant medical errors, turn in impaired or incompetent colleagues, and put patients' welfare above their own financial interests. But the anonymous survey, which was released last week, revealed that 46 percent of physicians with knowledge of serious medical errors (about 40 percent of survey respondents) failed to report colleaguesí errors at least once. A similar 45 percent of physicians who knew about an impaired or incompetent colleague failed to report it to the hospital or clinic where they worked, or to other relevant authorities. And a large majority of physicians when queried said they would refer patients to imaging facilities in which they were part-owners, with one in four reporting they would not disclose that fact to their patients. "Such behavior could be illegal under federal Medicare statutes concerning self-referral," noted the report, which appeared in the Annals of Internal Medicine. "This suggests that physicians may not be adequately aware of the legal restrictions on their behavior." The study was sponsored by Columbia University's Institute for Medicine as a Profession, which receives major funding from the George Soros-funded Open Society Institute and the Pew Charitable Trusts.
Independent Researchers Blast NTP Report on Bisphenol-A
The final bisphenol-A report issued late last month by the National Toxicology Program (NTP) relied on industry-funded assertions that the chemical is harmless, the Milwaukee Journal Sentinel reported. The NTP's expert panel reviewed a literature summary prepared by Sciences International, an industry-funded consulting firm subsequently removed from the process because the firm had worked for companies that manufacture BPA. According to the Journal Sentinel, scientists who follow the issue closely claim the final report still relied far more heavily on industry-funded studies than on studies conducted by university and government researchers. "There was clear evidence of bias" in this process, said Gail S. Prins of the University of Illinois at Chicago, whose work was cited in the final report. "They should have started all over." The final report concluded BPA may be of some concern to small children and fetuses, but poses little risk to adults.
FDA Needs More Resources, Better Science
The Food and Drug Administrationís science advisory panel, which is headed by a prominent industry scientist, concluded the agency is woefully underfunded and lacks the capacity to keep up with the latest science. The panel, chaired by Gail Cassell of Eli Lilly & Co., said the agency must beef up its capacity to monitor the safety of the nationís food supply; develop a program for managing the latest scientific advances in drug development; implement last yearís Institute of Medicine recommendations on drug safety surveillance; and empower scientists at the agency by appointing a top science officer for every division, and a chief scientist for the entire agency. The report called for increasing FDA spending by $1 billion a year by 2013, including an additional $350 million for food safety, $300 million for information technology, and $350 million for drug safety.
Judge: FWS Must Reconsider Sage Grouse Decision
The Fish and Wildlife Service ignored the advice of scientists when it declined to list the greater sage grouse under the Endangered Species Act, a federal judge ruled last week. The ruling by U.S. District Judge B. Lynn Winmill of Idaho found the agency excluded scientific experts from its decision not to list the species and failed to document experts' opinions as required by the law, thus violating the ESA's requirement that the "best science" be applied to listing decisions. The decision not to list the sage grouse was one of many agency decisions influenced by former Interior official Julie MacDonald, who resigned in May. The judge cited the Interior Department Inspector General report that found MacDonald, who had no biology background, had meddled extensively in the sage grouse decision. "MacDonald's principal tactic is to steer the 'best science' to a pre-ordained outcome," the ruling said.
Study Finds Systemic Bias in Meta-Analyses by Conflicted Docs
A new study in the latest British Medical Journal shows that conclusions of meta-analyses conducted by researchers with ties to industry are frequently at odds with the underlying data. After reanalyzing the results of 124 studies that pooled data on various antihypertensive drugs, the researchers found that 45 of 49 or 92 percent of meta-analyses conducted by researchers with financial ties to a single drug company came up with positive findings about that company's drugs. However, the underlying data included in the meta-analyses justified that conclusion in just 27 of the 49 or 55 percent of the studies. On the other hand, when non-profit researchers conducted the meta-analyses, either alone or in tandem with researchers with ties to the drug industry, 27 out of 27 conclusions matched the underlying studies. "Meta-analyses, as with other study types, are open to the influence of systematic bias," concluded Veronica Yank of Stanford, and Drummond Rennie and Lisa Bero of the University of California, San Francisco. "Our study also exposes a failure of peer review."
Odds and Ends
Rep. Rosa DeLauro (D-CN), who chairs the subcommittee that oversees FDA funding, is demanding the agency investigate Tadataka Yamada, former head of GlaxoSmithKline's research department and now chief scientist at the Bill and Melinda Gates Foundation, before appointing him to the Reagan-Udall Foundation board. Yamada has been implicated in Glaxo's 1999 campaign to discredit University of North Carolina professor John Buse after he raised questions about the safety of its diabetes drug Avandia. . . . Documents obtained by Ecojustice and the Western Canada Wilderness Committee reveal that the government of British Columbia has been interfering in the process of identifying critical habitat for recovering species; the groups are calling for a federal investigation. . . . A task force of the American Psychological Association has recommended that the 148,000-member group eschew drug (and other) industry funds; limit industry's role at conferences, meetings and continuing education sessions; and adopt strict guidelines on conflict-of-interest disclosure; the APA currently requires conflict of interest disclosure for all of the more than 50 journals it publishes. . . . In a lawsuit against the Cleveland Clinic Foundation challenging his own dismissal for violating conflict of interest rules, Jay Yadav accuses CEO Delos "Toby" Cosgrove and the CCF of promoting a heart-valve device sold by Edwards Lifesciences Corp. without telling patients both Cosgrove and the clinic get royalties from its sale, the Wall Street Journal reports. . . . The FDA has issued two waivers for its non-prescription drugs advisory committee meeting on Dec. 13-14, which will consider allowing Merck's generic statin drug for lowering cholesterol, lovastatin, to be sold over-the-counter, and doubling the allowable dose of the OTC cold medicine phenylephrine (contained in Sudafed and Robitussin, among others). The FDA review of industry-funded trials of phenylephrine showed half of 14 "poorly designed" tests at the lower dose showed no improvement in congestion symptoms; the evidence for efficacy at the higher dose also is mixed, the reviewers noted. . . . Meanwhile, a New England Journal of Medicine Perspective by Baltimore Health Commissioner Joshua Sharfstein and colleagues calls on the FDA to immediately order companies to withdraw OTC cold medications sold for young children (Sharfstein petitioned the FDA to take that action several months ago.) An FDA advisory committee recommended the move in October.
Cheers and Jeers