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SAFETY IN THE BIOTECH INDUSTRY

Posted Apr 01 2012 2:08pm
THE NEW LONDON DAY
Whistleblower now reluctant biotech safety spokeswoman
By Lee Howard
Publication: The Day http://www.theday.com/article/20120401/BIZ02/304019913/1018
Published 04/01/2012 12:00 AM
Updated 04/01/2012 12:04 AM

Dana Jensen/The Day
Becky McClain, a former Pfizer scientist who won a $1.37 million lawsuit against the company after becoming ill on the job but has not received any of the money, sits in her home last week. Pfizer is fighting the decision in the 2nd Circuit Court of Appeals.

Dana Jensen/The Day
Becky McClain, a former Pfizer scientist who won a $1.37 million lawsuit against the company after becoming ill on the job but has not received any of the money, sits in her home last week. Pfizer is fighting the decision in the 2nd Circuit Court of Appeals.
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Former Pfizer Inc. molecular biologist Becky McClain calls herself a "reluctant activist" now that she has become a national spokeswoman for biotech safety after winning a $1.37 million judgment two years ago against her former employer.

"I'm a scientist," the Deep River resident said. "I'm not schooled in public speaking."
But McClain, who won a jury award on April 1, 2010, against Pfizer after being fired following a series of safety complaints and what she says was exposure to a novel virus at the pharmaceutical giant's Groton laboratories, has been taking speaking engagements around the country to inform the public about the dangers of unregulated biotech laboratories.

In 2010, she received a Civic Courage award from a group associated with consumer activist Ralph Nader. She also is on the board of the Alliance for Humane Biotechnology, which advocates for better safety conditions at laboratories, and serves as executive director of the Injured Workers National Network.
"We've got a serious public health and safety issue that's not being addressed," she said. "It's like a horrible weight on my shoulder."

Just last week, she flew to California to speak at the Center For Genetics and Society in Berkeley about synthetic biology - a technique that enables scientists to engineer artificial life forms from scratch - which she sees as a new threat to public safety.

McClain claims to have been exposed to a dangerous virus while working at a Pfizer lab in Groton, and has spent nearly a decade fighting a condition that she says sends her into periodic bouts of paralysis - though symptoms are less severe today than they were at the beginning.

"Becky provides a cautionary tale for the kinds of releases of organisms we can expect to see more of in the future," said Jeff Conant, communications director for the Global Justice Ecology Project, one of the groups that invited her to speak in California.
"The problem is the public doesn't understand ... that the regulatory framework failed," McClain said. "They think, 'Oh, we're protected because she won $1.37 million.'"

McClain has yet to see a dime from her court victory as Pfizer has appealed the jury verdict.
The case became bogged down in February 2011 when Judge Vanessa L. Bryant, who had presided over the two-week trial at U.S. District Court in Hartford, acknowledged that she had a conflict of interest. Her husband, attorney Tracy L. Rich, had hired the Hartford-based Jackson Lewis law firm - the same counsel that argued Pfizer's case in court against McClain - to represent Guardian Life Insurance Co., which he served as general counsel and executive vice president, according to court documents.

Judge Warren Eginton took over the case and, in June of last year, issued a ruling that Pfizer owed McClain an additional $450,000 for attorney's fees and nearly $460,000 for punitive damages.
In the ruling, Eginton backed the jury's decision, saying that it reasonably concluded that "Pfizer terminated McClain because she made statements about matters of public concern" and that McClain's complaints about worker safety "did not interfere with her job performance."

Pfizer said it is disputing the jury decision because McClain was fired for abandoning her job rather than for exercising her right to free speech.
"It was undisputed during trial that Ms. McClain was able to work but chose not to for close to a year and only after leaving her job open for that period did Pfizer terminate her employment," the company said in a statement last week.

The judge's ruling brought McClain's total award to about $2.3 million. McClain was represented by Steve Fitzgerald of New Haven and Bruce Newman of Bristol, two of the few attorneys, she said, who were willing to take on Pfizer.

Pfizer appealed the ruling to the U.S. Second Circuit Court of Appeals, and McClain says it could be another year or more before the case is decided. McClain says she is hardly bitter, however, noting the court system gave her a more favorable hearing than she found from Pfizer or regulatory agencies such as the Occupational Safety and Health Administration.
"It's the only place I found some justice," she said.
Still, McClain says taking whistleblower complaints through the federal court system isn't the best way to address issues affecting public health and safety because justice takes too long.
"We need whistleblower laws that are efficient and swift, since the advanced technologies ... can be dangerous and can pose a significant and immediate threat to the public," she said.

Safeguards defended
McClain's appearance last week in California coincided with the planned expansion of the Lawrence Berkeley National Laboratory to Richmond, Calif., a billion-dollar venture funded partially with public money that potentially would create the world's largest synthetic biotech lab. The lab is at the epicenter of the synthetic-biology controversy because of the rapid growth of private biotech companies in California.

While synthetic biology has applications in the pharmaceutical field, fossil-fuel companies are beginning to invest in the process, hoping to develop a new generation of biofuels.
The industry is largely self-regulated, according to opponents, with neither the U.S. Food and Drug Administration nor the Environmental Protection Agency regulating the creation of new life forms.
"The risks that this rapidly growing field poses to worker safety, public health, social justice and the environment are poorly understood, and effectively unregulated," according to a group of ecological and worker-safety advocates that sponsored the forum, believed to be the first ever assembled by people not directly tied to the industry.

Supporters of the lab quoted in the San Francisco Chronicle last week insist it is safe.
"The whole point of synthetic biology is to make every step in the process more predictable and more reliable," said Jay D. Keesling, founder of the Berkeley lab's synthetic biology department.
Likewise, Pfizer said in a statement that it has a robust system in place to ensure compliance with environmental health and safety regulations.
"We have an active biological safety network, comprised of experienced biosafety professionals from across the company, that establishes and progresses biosafety program objectives for the company including robust risk assessment and management," Pfizer said.

Pfizer fought McClain for years in court over releasing records that would indicate the kind of virus to which she was exposed, with the company claiming the documents contained trade secrets. A judge eventually ordered Pfizer to release the exposure records, at which time the company said it couldn't locate them, McClain said, though Pfizer in court documents says it has released everything in its possession and even has allowed McClain and one of her attorneys to perform an on-site inspection in search of records.

"Pfizer has never claimed that they 'no longer have' records that Ms. McClain requested," the company said. "The issue is that while Ms. McClain has demanded 'exposure records,' no such records exist because she was not exposed to anything at Pfizer that caused her any injury."

Settlement offer rejected
McClain said the ability of Pfizer to deny the existence of the virus she says caused her harm only exposes the problem of allowing the biotech industry to police itself.
"We were at risk to exposure that could cause us harm," McClain said in her speech last week in California. "We also were at risk to carry an infectious agent out into the public."
McClain has campaigned over the past two years for more rigorous regulation of the country's booming biotech industry, which Gov. Dannel P. Malloy has been trying to tap into as a way of boosting the state's business climate. She decries the way academics are now constrained from criticizing the biotech industry because of university-corporate partnerships in "translational science" that fund research to discover new drugs.
"When a whistleblower or injured worker tries to confront an industry (safety issue), they run into a roadblock from every aspect," she said. "Pfizer has infiltrated almost every major university in the country."

McClain said she marches on as an advocate for worker safety, despite an aversion to public speaking and the fact that all of her expenses usually are not covered by the groups who want to hear her story. But she feels she must continue to speak out, and has rejected several offers by Pfizer to settle her case out of court because of the "gag order" that she says likely would result from taking the company's money.

"If I had not gotten sick, I wonder if I ever would have gone through this," she said.
With so few avenues left to get her message across, McClain said her best hope is for the public to begin protesting, as occurred earlier this year when eight people from the Occupy movement were arrested outside Pfizer's Groton laboratories.

"The government is no longer going to protect you," she said, "that's why the community has to get involved."
l.howard@theday.com
Visit The Day website to comment  http://www.theday.com/article/20120401/BIZ02/304019913/1018
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