Fast-Multiplying Lawsuits Can Stymie Medical Science, Authors Warn

[Guest guest]

Fast-Multiplying Lawsuits Can Stymie Medical Science,

Authors Warn

06 Jan 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

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 S. Perlmutter, M.D., professor of

neurology, radiology and physical therapy and associate

professor of neurobiology, is senior author of the paper.

Racette BA, Bradley A, Wrisberg CA, Perlmutter JS. The

impact of litigation on neurologic research. Neurology,

December 26, 2006.

Washington University School of Medicine's full-time and

volunteer faculty physicians also are the medical staff of

-Jewish and St. Louis Children's hospitals. The

School of Medicine is one of the leading medical research,

teaching and patient care institutions in the nation,

currently ranked fourth in the nation by U.S. News & World

Report. Through its affiliations with -Jewish and St.

Louis Children's hospitals, the School of Medicine is

linked to BJC HealthCare.

Washington University in St. Louis

One Brookings Dr., Campus Box 1070

St. Louis, MO 63130

United States

http://www.wustl.edu/

[Guest guest]

Sharon, thank you for posting this.

We all should save this article and use it in our letters to our

Congresspeople and Senators to ask them to

STOP these attempts to harass and retaliate against science, somehow.

What we are doing is setting our country back. More and more important

research is being done elsewhere and

one of the main reasons is that almost all public funding in the US these

days comes with strings attached.

For example, I've been told that even just mentioning indoor mold is a grant

killer.

So, for the last several years, much of the significant research on the

health effects of mycotoxins has had to been done by spinning the goals

differently.

For example, by putting Gulf-War syndrome or similar related issues into the

grant application.

Anything BUT something which effects LOTS of people like mold. That is the

exact opposite of the way this should be done.

The grants, the funding, should go TO finding cures for things which hurt a

lot of people.. NOT away from them.

On 1/7/07, snk1955@... <snk1955@...> wrote:

>

>

> Fast-Multiplying Lawsuits Can Stymie Medical Science,

> Authors Warn

> 06 Jan 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

> 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 S. Perlmutter, M.D., professor of

> neurology, radiology and physical therapy and associate

> professor of neurobiology, is senior author of the paper.

> Racette BA, Bradley A, Wrisberg CA, Perlmutter JS. The

> impact of litigation on neurologic research. Neurology,

> December 26, 2006.

> Washington University School of Medicine's full-time and

> volunteer faculty physicians also are the medical staff of

> -Jewish and St. Louis Children's hospitals. The

> School of Medicine is one of the leading medical research,

> teaching and patient care institutions in the nation,

> currently ranked fourth in the nation by U.S. News & World

> Report. Through its affiliations with -Jewish and St.

> Louis Children's hospitals, the School of Medicine is

> linked to BJC HealthCare.

> Washington University in St. Louis

> One Brookings Dr., Campus Box 1070

> St. Louis, MO 63130

> United States

> http://www.wustl.edu/

>

>