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By
Michael Purdy
Jan.
3, 2007 -- 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 aren'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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