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Fast-Multiplying Lawsuits Can Stymie Medical Science, Authors Warn

Class-action lawsuits can significantly slow or halt science's ability to establish links between neurological illness and environmental //factors produced by industry, a team of scientists and lawyers warns in the journal Neurology.

The authors caution that litigation's effects could seriously impair efforts to identify compounds that contribute to a wide variety of diseases, including Parkinson's disease, Alzheimer's disease and amyotrophic lateral sclerosis (ALS). They provide suggestions for policy changes to help shield scientists and their research. Recommendations include enhancing privacy protections for patient data obtained in research projects and eliminating financial conflicts-of-interest for scientists actively involved in research related to the litigation.

The lead author, Brad A. Racette, M.D., associate professor of neurology at Washington University School of Medicine in St. Louis, writes from personal experience: His studies tentatively linking welding to increased risk of Parkinson's disease resulted in a torrent of subpoenas for research data. Responding to them slows or stops his follow-up research.

"Participation in the legal system can be a huge burden on a researcher's schedule," Racette says. "There comes a point where a scientist needs the right to be able to say, testifying in court is not what I'm supposed to be doing, I'm supposed to be studying disease."

In addition to the scheduling challenges, parties involved in lawsuits often demand extensive disclosure of scientific data that disrupts research and threatens the privacy of patients and research volunteers. The two lawyers who are coauthors on the Neurology article, Ann Bradley and Carrie A. Wrisberg, worked with Racette to defend his data from unreasonable disclosure requests.

"I'm fortunate in that I work for a university that was willing to defend the value and privacy of our research data," Racette says. "Other scientists a ren't so lucky."

The federal Health Insurance Portability and Accountability Act (HIPAA) prohibits release of data that can be used to identify patients, Racette notes. However, in many instances the extensive volume and particularity of data demanded by lawyers may still permit research subjects to be identified.

"To protect patient privacy and the value of our research data, we need specific, across-the-board restrictions on information that can be released in the courtroom," he says. "For example, Illinois has a law that designates medical research data as protected. That should be a model for other states."

The authors note that the substantial financial interests at stake in lawsuits often leads to biased research by well-paid expert witnesses. They cite the example of a Texas doctor found to be overdiagnosing a disease known as silicosis. The doctor had a financial interest in the number of patients diagnosed.

Peer review is of course a part of the regular scientific process, Racette notes, but a knowledgeable expert can design a study with a predetermined goal of discrediting earlier studies that linked a suspected toxin to a disease.

Industries on the defensive have also attempted to impugn the credibility of researchers. As an example, the authors cite the case of Herbert Needleman, M.D., professor of psychiatry and pediatrics at the University of Pittsburgh and the first scientist to link lead exposure to low IQ levels in children. The lead industry attacked Needleman's integrity, alleging academic fraud and triggering investigations by the Federal Scientific Integrity Board and his university. The investigations failed to find any evidence of academic fraud, and Needleman's results were later replicated, leading to beneficial changes such as the removal of lead from gasoline.

"It's really quite an eye-opener," Racette says. "Herb Needleman had to endure great personal and financial hardships , including the prospect of career loss and $85,000 in personal legal fees, all because he dared to study something produced by a powerful industry that might be harmful to people."

Racette admits that the difficulties litigation has imposed on his research has, at times, made the thought of switching his focus to a different area tempting. But he says he's much too stubborn to ever seriously consider such a step.

"To cure or prevent intractable disorders like the one I focus on, Parkinson's disease, scientists need to be free to investigate many different potential causes, including environmental factors produced by industry," he says. "We hope to get a national dialogue going about how we can create an environment where scientists are as free as possible to do good, unbiased research."

Racette's frequent collaborator Joel S. Perlmutter, M.D., professor of neurology, radiology and physical therapy and associate professor of neurobiology, is senior author of the paper.

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