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The source of this article is ScienceDaily: http://tinyurl.com/cze26 Survey: Drug companies influence studies By STEVE MITCHELL WASHINGTON, May 25 (UPI) -- A survey released Wednesday indicates many university medical schools permit the pharmaceutical industry to influence what gets published from industry-sponsored drug studies. The findings raise concern because the industry provides 70 percent of clinical drug trial funding in the United States and the potential of pharmaceutical companies to withhold negative study results can have devastating consequences. "Partnerships between industry sponsors and academia are absolutely essential to the advancement of medical science, and the public benefits incalculably from them, but these relationships have to be carefully managed to avoid problems," Michelle Mello of Harvard University, the study's lead author, said in a statement. "Further dialogue about how to structure them would be helpful in balancing sponsors' needs against investigators' academic freedom and the public's interest," Mello added. Her study appears in the May 26 issue of The New England Journal of Medicine. Dr. Peter Lurie, of the watchdog group Public Citizen in Washington, said he is concerned patching up the gaps in academia will only shift the problem to private companies, called contract research organizations or CROs, that conduct research on behalf of the drug industry. CROs may have less incentive to publish studies than academic researchers and may be more likely to bury negative results, Lurie told United Press International. "Really, what we're facing here is a race to the ethical bottom," Lurie said. "Absent national standards that apply to all of academia and private companies, the temptation to engage in that race will always be there." "The article discusses hypotheticals rather than reality," said Ken Johnson, a spokesman for the Pharmaceutical Research and Manufacturers of America, or PhRMA, a trade group representing the industry. Johnson told UPI that PhRMA has established principles for conducting drug studies with university researchers. The principles stipulate "sponsors have a right to review manuscripts, but ... not to suppress or veto publications" in journals. The principles also "indicate sponsors of studies typically own the database of results of the trial, but agree to make the information available to clinical investigators or authors," he said. However, in two recent incidents -- the removal of Vioxx from the market because of cardiovascular risks and the use of anti-depressants in children -- there were allegations drug manufacturers did withhold data from academic researchers that indicated there were safety problems. In the new study, Mello and her colleagues sent 107 university medical centers questionnaires about their policies for conducting research sponsored by industry. They found more than 85 percent of medical centers said they would not allow industry sponsors to revise manuscripts for publication in journals or give them the authority to decide whether results of a study should be published. Some of the centers said they did allow industry significant control over the handling of research results. For example, 24 percent said they permitted industry sponsors to insert their own statistical analyses in manuscripts, and half said they permitted industry personnel to draft the manuscript. About 41 percent said they allowed industry to prohibit investigators from sharing research results with third parties. The influence of industry over what gets published has long been a concern -- even before the problems surrounding Vioxx and anti-depressants gained nationwide publicity. The issue received national attention in the 1990s when Boots Co., which later became Knoll Pharmaceutical, reportedly tried to suppress publication of a study it funded at the University of California, San Francisco. The study showed its thyroid drug was no better than three other competing generic drugs. Knoll eventually settled out of court, agreeing to pay $135 million, but Betty Dong, the UCSF researcher who conducted the Knoll study, estimated $356 million would have been saved annually if consumers had been prescribed the cheaper generic drugs. In 2001, 11 medical journals began requiring principal authors of studies to state in writing they had full access to the data and they alone made the decision to publish. "In 2005, has anything changed?" Dr. Robert Steinbrook, a national correspondent for the New England Journal of Medicine wrote in an accompanying perspective. "The short answer is no." Steinbrook noted that Congress and the medical community have begun to take notice of the situation. Several medical organizations have embarked on efforts to standardize clinical-trial agreements between industry and academia. The Fair Access to Clinical Trials Act of 2005, introduced in the Senate last February, would make it illegal for industry and academic researchers to engage in agreements that limit or prohibit the publication of study results. The proposed law, however, has not gained much momentum in Congress and, in the meantime, there are signs that industry may be shifting its research to CROs, Steinbrook wrote. Industry funding of trials at CROs increased from $1.6 billion in 1994 to $7.6 billion in 2004. Steve Mitchell is UPI's Medical Correspondent. E-mail: [log in to unmask] Copyright 2005 by United Press International. 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