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Found this article in the our Rochester Democrat and Chronicle newpaper. Thought it might be of interest to the list. Donna and John(53/46/45) Testa Rochester Democrat and Chronicle UR takes stand on research bias By Michael Wentzel Democrat and Chronicle (Friday, October 12, 2001) -- Starting this month, the prestigious journal Nature will require scientists who submit articles about drug trials and other research to disclose any financial interests related to their studies. The high-profile effort to reduce the impact of hidden researcher bias won't bother some scientists at the University of Rochester. They follow far tougher rules that prohibit any financial ties. Scientists and physicians at UR's Clinical Trials Coordination Center have promoted unrestricted publication rights for years. Several other prominent publications, including the Journal of the American Medical Association and The New England Journal of Medicine, also have instituted new policies designed to support a scientist's right to publish -- even if the research shows a drug has failed to work. The UR group's reputation of independence now is attracting more money and contracts from pharmaceutical and medical companies. Since 1997 alone, the coordination center at UR has received more than $40 million for drug trials. "More and more companies want an honest broker," said Dr. Ira Shoulson, UR professor of neurology and pharmacology. "They need a group to look at a drug, weigh in and let the chips fall where they may." Sheldon Krimsky, a Tufts University professor who recently published a study of conflict of interest in scientific and medical journals, said the UR group is ahead of current thinking on the issue and more strict than federal agencies and many universities. "Drug research is very sensitive," Krimsky said. "They do it the way it should be done." Journal articles play a critical role in medical research. They can establish the value of a new drug or validate a new avenue of investigation. Physicians often rely on the studies detailed in journal articles in deciding whether to prescribe a drug. Some investors use the articles as a basis for putting money into a company. Journal editors adopted the new rules in response to concerns that some drug companies increasingly controlled use of research data and, in some cases, had tried to withhold results that were not favorable or presented them in a way that did not reflect the true findings. The financial relationship of a researcher to a company also could influence the way findings are reported, some critics said. "The use of clinical trials primarily for marketing, in our view, makes a mockery of clinical investigation and is a misuse of a powerful tool," an editorial in the Journal of the American Medical Association said last month. As part of the new requirements, authors of submitted articles will have to sign statements indicating they accept full responsibility for the conduct of the trial, had access to the data and controlled the decision to publish. The journals could refuse to publish authors who do not meet the criteria. The Clinical Trials Coordination Center at UR began operation in 1986, initially to oversee a large trial of a drug therapy for Parkinson's disease that was sponsored by the National Institutes of Health. Researchers at the UR and in dozens of medical centers in the United States, Canada and around the world are involved in the center's studies. The UR center, which employs almost 70 people, now runs trials of drugs for Huntington's disease, Tourette's syndrome, epilepsy, attention deficit disorder and dementia caused by HIV infection. In August, for example, the center released the results of the largest clinical study ever of potential treatments for Huntington's disease, which found that neither of two promising compounds slowed progression of the disease. "From the beginning, the free and unrestricted right to publish has been at the heart of what we do," said Shoulson, the center's founder. That means when a drug company funds a study, the center's researchers retain the right to write the findings and publish the data. The center's constitution also bars participating researchers from benefiting financially in any way from their involvement in a study or from knowledge obtained through the study. They cannot own or trade in a company whose drugs or products are being investigated. They must agree not to inform relatives or friends about the research. They can't serve as paid consultants to a company involved or related to a study. Scientists fill out and sign annual disclosure statements detailing their interests. A group of democratically elected scientists oversees the system. "We want very strict rules about conflict of interest," said Dr. Karl Kieburtz, a UR professor of neurology who directs several of the center's studies. "We take people at their word. No one has ever been caught lying. No one has tattled." During the UR center's early years, few drug companies hired the organization to run trials, Shoulson said. Federal grants then provided the only support, but that has changed. The center has 18 studies underway, in the planning stage or in analysis. Six are sponsored by pharmaceutical companies. The National Institutes of Health this week selected the center to run a $6 million, five-year study of several drugs for Parkinson's disease. It will be the largest study ever for Parkinson's. "The potential to influence thousands of patients lives make these issues of financial interest and publication more important," said Kieburtz, who will head the Parkinson's study. "Conflicts can undermine confidence in findings. That can cast the whole system into doubt and could threaten the development of new medicines." http://www.rochesterbusinessnews.com/1012story1.html ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn