Medical experts will be watching closely Monday when a scientist who says she has been intermittently paralyzed by a virus designed at the Pfizer laboratory where she worked in Groton opens a much anticipated trial that could raise questions about safety practices in the dynamic field of genetic engineering.

Organizations involved in workplace safety and responsible genetic
research already have seized on the federal lawsuit by molecular
biologist Becky McClain as an example of what they claim is evidence
that risks caused by cutting-edge genetic manipulation have outstripped
more slowly evolving government regulation of laboratories.

McClain, of Deep River, suspects she was inadvertently exposed, through
work by a former Pfizer colleague in 2002 or 2003, to an engineered
form of the lentivirus, a virus similar to the one that can lead to acquired immune deficiency syndrome, or AIDS. Medical experts working for McClain believe the virus has affected the way her body channels potassium, leading to a condition that causes complete paralysis as many as 12 times a month.

"If a worker in a plant as sophisticated as Pfizer is becoming infected
with a genetically engineered virus, then I think the potential is
everywhere," said Jeremy Gruber, president of the Council for
Responsible Genetics, a public interest group created to explore the implications of genetic technologies.

"Genetically engineered viruses are commonly worked on at your average
university," Gruber said. "The public has a right to know what
regulations are in place and what regulations are required to fix an
industrywide issue. We need to have a conversation about this. Ms.
McClain's attempt to do that has been hampered at every turn, by the
courts and by regulators."

Pfizer disputes all of McClain's claims and says it fired her in 2005
because she refused to come to work. The global pharmaceuticals
manufacturer, with research labs in southeastern Connecticut, defends
its safety practices and denies that McClain's physical disability is
related to exposure at its Groton lab. The company says she did not
link her disability to workplace exposure until after she was fired.

As a molecular biologist, McClain studied cells on a molecular level, manipulating genetic codes in an effort to develop vaccines.
During the period at issue in the suit, McClain worked in Pfizer's
Human Health Embryonic Stem Cells Technologies, Genomic and Proteomic
Sciences and Exploratory Medicinal Sciences Group.

Hostile Exchanges

The sharp disagreement between McClain and her former employer mirrors a half-dozen or so
years of hostile litigation leading to Monday's jury trial in Hartford
before U.S. District Judge Vanessa L. Bryant. McClain will argue that
she was wrongfully dismissed and is entitled to unspecified damages. In
the run-up, Pfizer attacked McClain's legal claims, and she questioned
the company's corporate integrity.

On the advice of her lawyers, McClain would not discuss her suit last
week. Neither would her lawyers, nor those representing Pfizer.

But McClain has claimed in her suit and in earlier public statements
that she was fired after experiencing symptoms of illness and after
complaining to the U.S. Occupational Safety and Health Administration
about safety in her Pfizer lab.

OSHA dismissed McClain's complaint. In a decision published after
McClain's termination, the agency criticized her for refusing to return
to work in spite of "Pfizer's substantial efforts" to address her
concerns. In a speech last year to a labor safety group in California,
McClain said she was told by an OSHA investigator that the federal
agency's legal authority has not kept pace with developments in
sophisticated medical research.

A series of angry, pretrial exchanges developed over McClain's efforts
to compel Pfizer to give her precise information about the DNA
sequencing of the engineered lentivirus she suspects infected her.
Pfizer says it responded to all of McClain's requests, in accordance
with the law. Her advocates called Pfizer's assertion preposterous and
claimed the company has not produced — perhaps because it is subject to
trademark — the sequencing data that could enable scientists to
engineer a genetic cure.

Over the course of pretrial argument, the number and breadth of
McClain's legal claims against Pfizer have been reduced from eight to
two. Last month, Bryant dismissed the most significant of the eight
claims: that willful and wanton misconduct by Pfizer resulted in lax
laboratory procedures. McClain claimed laxity contributed to her
exposure.

McClain's advocates point to language in Bryant's ruling that suggests
the misconduct allegation was dismissed, at least in part, because
state law requires such claims to be resolved by state workers'
compensation rules. But Pfizer says Bryant's ruling is another
vindication of its assertion that no evidence exists to support
McClain's contention that she was infected by a viral exposure at
Pfizer.

"We have thoroughly investigated Ms. McClain's claims and our
investigation concluded that her workplace was safe and that she was
not infected by any virologic materials while she was employed by
Pfizer," company spokeswoman Elizabeth Power said.

Bryant's ruling means the trial will move forward under McClain's two
remaining claims, both of which involve free speech protection. She
says Pfizer fired her in violation of Connecticut's whistle-blower law
after she raised questions about Pfizer lab safety to OSHA. And she
claims her dismissal also was in retaliation for questions she raised
in discussion with Pfizer colleagues about safety practices. In
addition to performing her research duties, McClain served on a lab
safety committee for at least part of the nine years she was employed
by Pfizer.

Medical Evidence

Pfizer has taken the position that Bryant's ruling in March means no evidence will be admitted at the
trial concerning McClain's health or her claim that it was destroyed by
bad lab procedures. McClain's advocates, again, disagree. Because
McClain is suing under a whistle-blower claim, they believe she will be
allowed to present evidence about why she figuratively blew the
whistle. If her health and safety are the reasons, they say, the judge
could allow jurors to hear evidence in those areas.

In her suit, McClain says that Pfizer hired her in 1995 and that, in
2000, she became involved in human cellular research associated with
vaccine development. She later learned, the suit says, that colleagues
in her lab were working with infectious, genetically engineered
viruses, including the lentivirus she suspects causes what her
physician calls "acute intermittent paralysis."

The suit describes lab events that McClain suggests could have infected her.


read more