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Researchers — not the drug companies who fund the studies — will have final editorial control over medical studies published in the world’s leading medical journals. That’s the announcement made from the International Committee of Medical Journal Editors at its annual meeting held in May in Philadelphia. The policy changes, along with an editorial explaining them, will be published in the respective journals in September.
Under the changes, authors will have control over the content of reports submitted to journals for publication in addition to having access to all data gathered during the study. At stake are millions of dollars in research funds because the results determine whether the U.S. Food and Drug Administration (FDA) approves the drug or allows additional uses for existing drugs. The changes were made because editors were concerned that drug companies sometimes wield too much influence over article content and have veto powers over what is submitted for publication.
Journals are overreacting to a few examples of questionable conduct, counters Jeff Trewhitt, a spokesman for the Washington, DC-based Pharmaceutical Research and Manufacturers of America. "In the vast majority of cases, these studies are conducted soundly and with scientific credibility," he says. "If you play fast and loose with the data, it will catch up with you eventually. If you lose credibility with the FDA, doctors and patients, you have a major problem, and companies are very aware of this," explains Trewhitt.
Editors, however, are concerned over instances where study authors do not have access to data and only see what the drug sponsor gives them. In a few cases, drug companies have attempted to block publication of unfavorable results. The drug companies state that contractual agreements allow them final approval of what gets released.
"Nobody knows how often agreements get written that way. The number of egregious examples is small, but the sense is a lot more of that goes on than anyone is able to document," says Frank Davidoff, MD, editor emeritus of the Annals of Internal Medicine.
Publications agreeing to the policy change include the New England Journal of Medicine (Boston), The Lancet (London), the Journal of the American Medical Association (Chicago), the Annals of Internal Medicine (Philadelphia), and the national medical society journals of Australia, Canada, the Netherlands, New Zealand, and Norway.
President Bush’s stipulations supporting limited stem cell research included the creation of an oversight council. The council will be responsible for monitoring research and recommending appropriate guidelines and regulations for stem cell research.
The council also will consider medical and ethical ramifications of biomedical innovations from stem cell research. The President named Leon Kass, a biomedical ethicist at the University of Chicago, as chair of the council. Members of the council will include scientists, physicians, ethicists, lawyers, and theologians.
The federal funding for stem cell research will apply only to existing stem cell lines derived from embryos that have already been destroyed. The existing stem cell lines can regenerate themselves indefinitely, which will create ongoing opportunities for further research.
A former researcher at the University of Oklahoma in Tulsa may be banned from further research from the U.S. Food and Drug Administration (FDA). The FDA alleges that the researcher violated its regulations intended to ensure patient safety in trials involving investigational new melanoma vaccines. Specifically, the researcher failed to abide by safety provisions in the protocol and made changes to the protocol before obtaining approval from the university’s IRB, according to the FDA.
The Office for Human Research Protections (OHRP) first discovered violations to patient safety rules last year. OHRP ordered the University of Oklahoma Health Sciences Center at Tulsa to end all government-funded clinical research involving human subjects. The ban was later lifted after the university disbanded the IRB at the Tulsa campus and instituted additional reforms.