Becky McClain Addresses the Safety of Biotechnology

Injured
Pfizer molecular biologist and
biotech worker Becky McClain presentation at synthetic biology
conference

Becky McClain is the executive director of the Injured Workers National
Network.

She was a molecular biologist at Pfizer in
Groton, Connecticut and was

contaminated by the company due to lax
health and safety standards. She spoke

on March 29, 2012 at an international
conference called "Unmasking the Bay Area

Bio Lab and Synthetic Biology: Health,
Justice, And Communities At Risk.

For more information go to www.synbiowatch.org or www.iwnn.org

SAFETY IN THE BIOTECH INDUSTRY

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.

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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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COMMENTS (1)

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

THE SAFETY OF BIOTECHNOLOGY: TARRYTOWN CONFERENCE

Tarrytown 2011 Conference

Connecting the Dots to Public Awareness of Public Health and Safety in Biotechnology

 SPEAKER: Becky McClain, July 26, 2011 Biotechnology health and safety advocate and whistleblower

Thank you, Osagie, Richard Hayes and staff of CGS for this invitation to provide my thoughts at Tarrytown 2011.
I stand here today as career molecular biologist turned activist because of ethical and moral concern.

While working in an embryonic stem cell lab at Pfizer, the largest pharmaceutical company in the world, I reported ongoing public health and safety concerns to management. I soon began to experience retaliation that escalated into hostility. Soon there after, I became the victim of the very safety violations I was trying to prevent. An untrained lab worker used a human infectious genetically engineered virus, without suitable biocontainment, on my personal workspace. I began experiencing periodic paralysis and spinal pain – a result consistent with the DNA- coded effects that had been engineered within the pathogen.

This experience of walking through the fire, of being both a whistleblower and injured worker, provided me a unique view into the social and political cultures within the biotech industry, which hinder human rights and public health and safety. I hope my perspective today can contribute to connecting the dots at Tarrytown to enhance the movement for better protection for both workers and the public.

In April 2010, an eight-member jury in the state of Connecticut unanimously ruled that Pfizer had retaliated against me and engaged in willful, malicious indifference toward my speech concerning public health and safety.

This unanimous decision by a jury is very significant. It provides a clear example that if the general public ever does becomes aware of what is truly going on in the biotech industry … there will be an outcry… the public will quickly realize that self-policing and the lack of oversight within the biotech community are not providing adequate protections for their safety, their family’s safety or the public’s safety. So, my trial outcome should give us all hope and confidence that if we engage in a well orchestrated and strategic campaign towards public awareness, we could make a significant impact on the critical health and human rights concerns which underlie advanced biotechnologies.

Now I say “well-orchestrated campaign” for a reason. Because despite my story and other stories of injured biotech workers who have been made ill, maimed or killed, we still face immense challenges to inform the public. The one challenge we all face in common is the state of affairs brought about by a biotech industry, riddled with conflicts of interest and left to regulate itself. Networked with various businesses, academic institutes and governments, this complex of economic and political drivers makes for a formidable challenge to any would-be whistleblower, injured worker or concerned citizen who makes attempts to play fair in bringing about safety or social and human rights balances.

One of the first barriers is finding affordable and qualified legal help in a timely manner. The lack of experts and economic disparity make these high-risk cases. And although I am extremely grateful for winning my lawsuit, the economic reward, if it ever does come, comes after a long difficult battle. Many would-be whistleblowers would not be able to endure the economic hardships it requires. With all these limitations, the vast majority of legitimate claims cannot be brought to justice or to the public’s eye.

Government agencies use revolving door policies to establish special economic relationships with business. This creates certain boundaries that will not be crossed at the expense of individual and public health rights, even to the point of using disingenuous tactics. For example, during an interview session with OSHA, I was guaranteed that my notebooks were safe as I left for a lunch break. But while away, the OSHA investigator, nonetheless, made a copy of all my attorney-client privileged documents from my personal notebook without my consent or knowledge. And then later in the investigation, OSHA demanded a settlement offer from me, only to use it afterwards to write in their report that I had a character flaw because I was out to get money. OSHA refused to follow statutory procedure, never performed a safety inspection or addressed my serious safety complaints even with documents in hand showing serious biocontainment issues, exposures and illnesses in our department at Pfizer. The end result is that government agencies act in capricious ways, providing no consistent platform or protection for injured workers or whistleblowers to speak freely and inform the public.

And even more egregious against human rights, both federal OSHA and CT-Worker Compensation established terrible precedents of denying the disclosure of exposure records. These actions eliminated my rights and biotech workers rights to independent directed medical care and to any remedy through workers compensation. Consequently, injured biotech workers, like David Bell, who incur hundreds of thousands of dollars of medical bills, are forced onto social security disability at a cost to the public instead of the employer who engaged in unsafe work practices.

I also discovered walls of resistance amongst biomedical researchers within prominent academic institutes who partnered with Pfizer. Comparable to the overt anti-biotech crusaders who make grandiose and false claims that all genetically engineered products are harmful, these scientists, who come bearing credentials and big salaries, take the opposite extreme. They make overt statements claiming that all genetically engineered viruses used in BL2 labs are engineered to be safe and cannot cause harm, statements that are patently irresponsible and unfounded in science.

The biomedical industry has shown great confidence in using strategic alliances to manage their “dirty laundry” while moving on the fast track to “profits over safety” in the name of innovation. And why shouldn’t this industry proceed with confidence? When Pfizer received a $1.37 Million dollar verdict against them at the conclusion of my trial, their stock didn’t drop to reflect any consequences. In fact, soon after, many biomedical universities lined up with hands open wide in acceptance of $100 million dollar research deals with Pfizer. The State of Connecticut ignored pubic health and safety concerns even after a Connecticut jury agreed that my safety complaints where of serious public concern. Instead the state invited a Pfizer manager, who had been intimately involved in the retaliation and safety abuses in my case, to give a talk at this year’s STEMCONN 2011 conference on the topic of “Stem Cells for Profit?”

With injured workers and whistleblowers up against significant legal and economic roadblocks, created through a web of conflicts of interest, and the rare legal victories not changing bad behavior, we need to engage in a collective and strategic campaign to protect public health and safety.

The facial expressions from the jurors at my trial, told a story of disbelief and shock. I have confidence that with effective public awareness, the health and safety and human rights concerns within advanced biotechnologies will begin to be addressed. So if we are to connect the dots, let us connect with open dialogue and let us network to build capacity and to form a strategic framework to increase public awareness.

Becky McClain Recieves Award and Speaks at Calaway Award Presentation in D.C

Becky McClain, injured Pfizer Molecular Biologist and Health and
Safety Advocate speaks at Callaway Awards Presentation on
12/8/2010 in Washington, D.C.

I met Becky McClain several years ago after she had become ill from a biological exposure at Pfizer. It was a very interesting connection as I have been exposed (like millions of others) to the Lyme disease spirochete which may ...or may not have escaped from Plum Island or other nearby labs. I have attended some of the Pfizer/McClain trial sessions and have been included in some of Becky's activism efforts. I am very proud to know her and wanted to share with all of you what she is fighting for. Listen to Becky's speech below where she emphasizes the importance of worker safety and how the public should also be concerned and become involved. This issue of worker safety and biological safety affects all of us.

What Is The Callaway Award? Here is a description from Wikepedia
FROM WIKEPEDIA
Joe A. Callaway Award for Civic CourageFrom Wikipedia, the free encyclopedia


The Joe A. Callaway Award for Civic Courage is presented annually by The Shafeek Nader Trust for the Community Interest. The Callaway Award "recognizes individuals who take a public stance to advance truth and justice, at some personal risk".[1][2] In 2007, award recipients were: Dahr Jamail (independent journalist in Iraq) and Linda Peeno, M.D., (whistleblower and patient advocate).[3]
The first recipient of the award was Joseph A. Kinney, of the National Safe Workplace in Chicago, who was credited for his fearless advovacy of safety for America's workers http://en.wikipedia.org/wiki/Joe_A._Callaway_Award_for_Civic_Courage

Human Rights at Risk with Public Funding of Embryonic Stem Cell Research

By Becky A. McClain


As an embryonic stem cell scientist and an injured worker, I would caution the public about the recent political movement to reverse the Dickey Amendment and, thereby, legalize federal funding for embryonic stem cell research. Matter a fact, the public should be alarmed.


Why?


Disregard for human rights issues, which rise up and above the “religious right” concerns, have already adversely impacted the public. And, unfortunately, more adversities toward the public are on their way as embryonic stem cell research advances. These critical issues deserve thoughtful attention before a reversal of the Dickey Amendment should be even considered.


I should know.


I was denied directed medical care for exposures from dangerous embryonic stem technologies incurred while at work. Unbelievably, I was denied under the premise that “trade secrets” supersede a worker’s right to specific exposure information.


Really? Yes, really.


Welcome to the embryonic stem cell world, a world of legal quagmire where human rights and public rights are slated toward the chopping block. Chop! Chop! One down for worker’s rights.


Public Beware. If the embryonic stem community does not care about worker safety and worker rights, you had better believe they also do not care about public rights or public safety either.


In fact, the public has been fooled. The embryonic stem cell research industry is far from the altruistic persona it has painted itself to be. Rather, embryonic stem cell research is about big money, first and foremost. It is about securing a position of power within the economic and legal mainstream of the American public. That is why biotech worker’s rights regarding safety and healthcare have been denied. That is why, unfortunately, the public’s right will be denied too.


And the media has not helped. The media has purposely turned the human embryonic stem cell debate into a polarized “religion versus science” contest.


But issues lying in-between those two polarities contain much of the tainted meat that can negatively impact the public toward human rights. These concerns get no media attention. The public remains ignorant. In fact, the public lacks an understanding of the legal, social and cultural effects that could negatively impact them as advanced technologies move forward.


The “religious right” issue is only one of many concerns surrounding the controversial funding of human embryos for research. But it is not, necessarily, the most important.


For example, public health and safety is yet another concern in this unregulated research. But the public remains clueless. The public is not even aware that human embryos are being used for biological warfare research purposes in the United States .


The public is also not aware that other dangerous embryonic stem cell technologies are being developed in their neighborhood universities and biotech companies without adequate biocontainment measures, regulations or oversight. The public is not aware of how this unregulated and dangerous research can make them sick. Real sick.


And that’s not all. Human rights, scientific integrity, public transparency, patent issues, public rights, women’s rights, egg donations, workers rights, and legal rights, along with public health and safety are all important issues that have been left out of the human embryonic stem cell debate.


Under the current lack of public and human right protections, Americans should be on guard regarding allowing unfettered public funding toward human embryonic stem cell research.


It is in the public’s best interest to protect itself. And I assure you, as an embryonic stem cell researcher and injured worker, who has seen the dark side of the embryonic stem cell industry and who has personally experienced its immense power to thwart human rights, reversing the Dickey Amendment is far from being in the public’s interest.


Until the legal, social and cultural effects of human embryonic stem cell research can be brought to light, with more meaningful discussions to protect the rights and interests of the American people, the public should demand upholding the Dickey Amendment. The public should not advocate for public funding toward human embryonic stem cell research.


Becky McClain is an injured biotechnology worker who while working as a molecular biologist at Pfizer, Groton , became ill after she incurred exposures to dangerous genetically engineered viruses used in an embryonic stem cell lab. She recently won a freedom of speech and whistleblower claim in federal court against Pfizer which involved her public health and safety claims.

http://watchdogonscience.blogspot.com/2010/09/embryonic-stem-cell-research-funding.html

ANTIBIOTIC RESISTANT BRUCELLOSIS

ANOTHER LABORATORY BIOSAFETY CASE_BIOTECH WORKER SICKENED WITH DANGEROUS INFECTIOUS AGENT


In light of all the recent biosafety issues, another biotech worker has become infected by an infectious microorganism while working in an infectious disease laboratory at University of Wisconsin-Madison. The University has been fined and a Professor of Infectious Disease has been punished by removal of his laboratory privileges.


University of W-Madison Professor Gary Splitter worked on Brucella, a microorganism which can cause Brucellosis, a major zoonotic disease. The disease can infect animals and can also cause a contagious disease in humans. Brucella is considered a bioterrorist agent. A biotech worker had become infected while working in Splitter's laboratory.


The Wisconsin State Journal states: "His lab created antibiotic-resistant strains of brucellosis and inserted them into mice in 2007 and possibly earlier, university officials said, without approval from local or federal agencies. The concern is that if someone contracted the antibiotic-resistant version of the disease created in the lab, treatment might have been more difficult." "


Splitter will lose his laboratory privileges for five years due to this serious biosafety incident and since his laboratory was not within recombinant DNA NIH standards. The university was fined $40,000 for their role also in violations of laboratory and public health and safety standards.


Biosafety is a current worker safety and public health and safety issue. Injured biotech workers can remain ill and untreated in the United States since diseases from genetically modified organisms or laboratory strains are difficult to diagnose. In addition biotech workers have no legal rights to appropriate exposure records for treatment after incurring an exposure.


Although academic labs such as University of Wisconsin are mandated to follow NIH guidelines, private industry is under no such constraint, leaving a big gap in public health and safety standards.


The biotech worker in Splitter's lab who became infected with Brucella remains unidentified.
http://watchdogonscience.blogspot.com/2010/05/another-biotech-worker-infected-and.html

IN DEPTH INTERVIEW WITH BECKY McCLAIN

A Roach In The Kitchen-Interview With Injured Pfizer Molecular Biologist Becky McClain



http://www.councilforresponsiblegenetics.org/GeneWatch/GeneWatchPage.aspx?pageId=248

A ROACH IN THE KITCHEN

By CRG staff - interview with Becky McClain

After becoming seriously ill while working in a Pfizer laboratory and being denied workers' compensation, Becky McClain sued Pfizer for damages. In April, a judge awarded her $1.37 million, finding that Pfizer violated her right to free speech and her whistleblower rights. The judge dismissed McClain's claim that Pfizer's wanton misconduct had caused her to become infected by a genetically engineered virus in its labs, citing the lack of evidence. The Occupational Safety and Health Agency has told McClain that it cannot force Pfizer to turn over the exposure records that would provide this evidence, as they are protected trade secrets.

You went to court because of your own illness and Pfizer's conduct, but did you start seeing safety problems before you had any health problems yourself?

Yes. And I reported safety problems before I had any problems myself. That's what's so egregious about all this: it's not that there was an accident that I was exposed to, it's that they were careless, and willfully and wantonly disregarding appropriate safety precautions.

What were some of the big problems?

There were a lot of safety issues, but they to a large extent could have been solved by two things: either by giving us a break room with a door, with no scientific stuff going in there at all; or they could have given scientists offices outside the lab. That was a major problem. There are some labs where the dangers of exposure to materials are minimal. But when you're running a recombinant lab, bringing in genetically infectious viruses, you should use your common sense, and you shouldn't have scientists with administrative desks inside the laboratory where they are not afforded personal protection. That's just common sense.

It seems like an easy fix, too.

Pfizer reported that it would cost something like $1.6 million, and that's just ridiculous. I think they looked at how they could revamp the whole department for that cost, but all they had to do was get a six foot by ten foot room that we could share as a break room, with a door. That wouldn't cost $1.6 million.

So the break room was in the lab?

The break room was in the hallway. It was a working hallway, with biological refrigerators and freezers and people walking lab to lab carrying genetically engineered viruses, blood samples, monkey samples ... and that's where we were eating. We would find genetically engineered viruses where we were eating and drinking. We wouldn't find something every day, but I compare it to a roach in the kitchen: if you see a roach in the kitchen, you'd better know that there are a hundred roaches behind the wall. By the time you call OSHA to come in to kill that roach, it's gone.

One of the major issues was that when I was on the safety committee, I was told to stop formally documenting my safety concerns. Instead, the role of the safety committee was to perform in-house laboratory inspections. The laboratories were given advanced warning of the time and date of the inspection. So everybody had the opportunity to clean up the lab in preparation for the inspection. And so when we would do the safety inspection, we could check the box that everything's safe. Now Pfizer has all these wonderful safety inspections stating that everything's safe. But in actuality that was not the case.

We had evidence that people were getting sick shortly before and after a safety inspection, but if you look at the safety inspection report, the lab was completely safe. You see what they're doing? Pfizer was basically forcing the safety committee to do these half-bogus inspections that would create documentation that the labs were safe-but they wouldn't allow us to document anything else in between these inspections.

And this was a higher-up company policy that was handed down?

When the safety committee was formed, at the end of the meeting they gave instructions as to how we would start to perform these inspections using a form where you check boxes if the lab was in compliance. I didn't see anything wrong with that. But after that meeting, I started bringing up these additional safety issues regarding inadequate break facilities and scientists having administrative desks inside laboratories without adequate protection. But when I started bringing up these issues, some people on the safety committee stiffened up. So soon after I wrote a draft, a really rough draft, of a letter to the safety committee documenting some of these points ... and within two hours of submitting it, I get an email from management telling me to stop formally documenting these things. So what happened was that my role in the safety committee was not to report actual safety issues; it was just to conduct safety inspections. That's it.

When I went to OSHA I found that as scientists, we do not have legal rights to raise safety issues or to have the right to get them formally addressed. And you have to remember, we're working on state-of-the-art technologies. Even if we did have regulations, the regulations are going to be outdated because the science is constantly evolving. So safety forums for scientists are pertinent to ensure worker safety and public health and safety. There needs to be a formal way that scientists can get their safety issues addressed formally. This is dangerous-we're making genetically infectious viruses.

Even as other people started raising safety issues, Pfizer just ignored them. Their answer was, "We'll form a management team to address these." Three years later, they were never addressed. There's just no formal forum for scientists to raise safety issues and get them addressed, and we legally don't have the right to do that.

Do you think this is part of the reason that, although you won your case on free speech and whistleblower rights, a judge would not hear your case regarding whether you were infected in Pfizer's lab?

We had very good evidence, scientific evidence regarding the link of my illness to the exposure and the willful and wanton behavior of Pfizer. But, Pfizer was denying us pertinent exposure records necessary for us to meet the high standard of proof required by law to bring this to civil court. So in the end the judge would not allow the jury to hear the evidence regarding my illness and instead remanded it to workers comp.

If the jury would have had the opportunity to hear that count and the facts surrounding my injury, I do believe they would have ruled in my favor. Pfizer's duplicity regarding virus identities and their lack of appropriate documentation were appalling. Together with these facts and their lack of response to my safety concerns, it clearly implied willful intent. We had good evidence that the exposure caused my illness. I was hoping that my case would set a precedent for other injured biotech workers.

But the burden of proof of causation and intent required by Connecticut law is so outlandishly high and in favor of business... that no one seems to have a remote chance of bringing an egregious work-related injury claim before civil court.

And unfortunately, worker's comp brings no remedy either. Without the exposure records that Pfizer denies me, worker's comp is a dead end street. The sad part is...is that I am not alone in facing this predicament of having a work-related illness. Workers compensation is full of problems, leaving many workers abandoned with no healthcare or financial remedy for serious illness they acquired from work.

Because the burden of proof was on you, not the company?

Yes-and it should be, I'm not complaining about that. But one of the problems with the proof was that Pfizer refused to give me my exposure records.

And there is no law requiring them to give you those records?

No, there is no law under OSHA for a biotech worker to obtain the necessary exposure records needed for medical care upon a biological exposure. In fact OSHA ruled in my case that trade secrets supersede a worker's right to these records. That was one of the primary reasons why I had to file a civil claim in an attempt to obtain those records for my healthcare. So finally in civil court, the judge ordered them to give me the records, but Pfizer never gave them to us after numerous requests.

Let me back up so you know the history of what happened. I was exposed two times. The first issue was a biological hood which started making people ill. Prior to that, people were bringing genetically engineered viruses in there; and after they changed out the hood, it became recontaminated. So we didn't know: was this a biological agent that was making the hood become continually contaminated? Or was it a chemical problem? It was a mystery agent that was making people ill. I did know that people were using genetically engineered viruses, but the reason I didn't bring this up to OSHA right away is that I was told these were not human infectious viruses. I thought, oh well, I can't get sick from a non-human infectious agent anyway.

One of the other major details about the hood is that they purposely mistested the hood so that we couldn't collect adequate data for exposure.

How did they go about that?

How a hood works is that air is drawn in from where you put your hands in; 70% of the air recirculates within the hood, but 30% passes through filters and goes out the top of the hood into the lab. The exhaust is what was making people ill. When we asked Pfizer to please test the hood, because we had been getting sick for a year, they didn't bother to ask us how to test the hood. It's common sense how you would do it: air comes out the top, so where would you put the probe?

You'd put it where 30% of the air is coming out, at the top.

Right! You're not a scientist, but you get this-it's common sense!

So we got a knock on the door, and in come two men in biohazard suits. They looked like astronauts-they had respirators, oxygen tanks, everything. And they ask us to step out of the lab- can you believe this? They were all dressed up in biohazard suits, and I thought they were going to test adequately-they looked like professionals. But when we got the results back, we found they had purposely mistested. They never put the probe by the exhaust. They put the probe inside the hood, not even near the exhaust. The other thing was that we knew the contaminant was bound up in the HEPA filter in the hood, and we specifically requested that the HEPA filter be tested. All they had to do was test those filters, but they wouldn't test it. So they gave us these bogus results, and that's when my boss came up to me and pointed out the sampling error and said, "Listen, we're going to get in trouble for raising safety issues again, and I'm not going to have any part of this." He was afraid he was going to get fired.

Do you think this is why you got sick?

Where I had an etiological link to my illness was another exposure. In November of 2003, my coworker Bill Blake came up to me and asked if I knew what lentiviruses were. He had been told to work on my bench with a lentivirus experiment that he was doing. Now I'm not a virologist, I don't make genetically engineered viruses. I was making genetic expression systems that could be cloned into viruses -in layman's terms, genetic missile systems that could target a specific gene and blow it up. And Blake wasn't a virologist either. He was a tissue culture specialist, and all of a sudden he's working on these genetically engineered viruses, and he said they didn't give him any background papers, they didn't give him any training, and he didn't know exactly what this virus was. He didn't know if it was a human infectious agent!

So my understanding of lentiviruses at that time was that they were species-specific. HIV is a lentivirus, and we also were working on feline immunodeficiency viruses. Blake was working on lentiviruses with mouse embryonic stem cells, so I said, "I don't believe you could possibly be working with an HIV virus because you're working with mouse embryonic stem cells. It's got to be a mouse specific virus." But I asked him, "Could you please go check?" He had been working with this lentivirus without biocontainment on my bench for an entire month, and that was my private bench. I would at times work on that bench with my papers, doing lab reports, and I wasn't wearing gloves, so I could easily get exposed.

He came back the next day, and he did look a little bit nervous; but he said, "It's safe, but I'm supposed to decontaminate."

And did you get sick soon after he started using your bench?

I got sick exactly around the time he started using the lentivirus on my bench in October 2003, but it didn't click yet because I assumed he was telling the truth about the virus being safe and implying it was a non-human infectious agent.

As I started getting sicker and sicker, I thought, what's going on here? One doctor wrote in my report that I had some post-viral syndrome. By this time I was already on medical leave. That's when I started writing Pfizer, telling them I want the identity of these viruses that were used in my lab. I was coordinating this through OSHA now-they were advising me about how to go about doing this-but Pfizer told me to go take a hike, that no viruses were used in that lab. Well, I knew that was untrue.

Wait - they said no viruses were used in your lab?

Yes. They said that Bill Blake had never used a virus in that lab. So basically, I went to OSHA and told them Pfizer wasn't giving me the information. OSHA sent Pfizer a letter, and by law they had to tell me the identity of the biological agent. Pfizer immediately sent me the results of what Bill Blake was using. They said it was an HIV-derived lentivirus pseudotyped with VSVG. Let me explain what that is. HIV-derived lentivirus-you know what that is. It's a genetically engineered virus derived from the HIV virus. They take the HIV virus and they manipulate it-pseudotyped with VSVG, which is a virus in the rabies family which subsequently makes the HIV-derived lentivirus broadly and highly infectious.

If you are exposed to an HIV virus, you can only get it blood-to-blood. But the rabies family-you know how horribly infectious that is. It can infect through your eyes, if you breathe it in, if it gets in your mouth. So what they're doing now when they make genetically engineered viruses-and this is a BL2 lab-they can basically put a rabies-like coat on the HIV virus. Now you have an HIV-derived virus that can infect you like a rabies virus. You can imagine, as I'm working on this bench without gloves, doing paperwork ... all I have to do is touch it, put my finger in my mouth, and I'm infected.

Do you know if Bill Blake ever got sick from it?

He was all gloved up, and then he never worked on the bench again. I was the only one that I know of who was exposed to that virus.

So when I found all this out, I was just aghast. I could not believe it. And then I found out that the virus they were using in the hoods had been human infectious agents also-and they had told me they weren't! They had told me it was a mouse leukemia virus. They were bringing human infectious agents into the lab, and I was never notified.

And the people working on it, do you think they knew these were human infectious agents?

Bill Blake didn't know. He had never worked with viruses-I was really surprised that they had allowed him to do this. My boss should have known it was a human infectious agent.

At this point I'm hospitalized, and I'm getting sicker and sicker. They diagnose me with something called transient periodic paralysis, but they don't understand why I have this. Periodic paralysis is usually a genetically inherited disease. What was weird is that I don't have any of this in my family. Also, if you inherit this condition, you present at an early age -not at middle age.

I knew I had been exposed to genetically engineered viruses that were human infectious agents. They had given me the name of it, but that doesn't tell us anything. I went back to OSHA and told them that the name of a virus is not the identity of a virus. With a genetically engineered virus, each one is custom-made, and you can name it whatever you want to name it. So I went to OSHA and Pfizer and told them they needed to give me the genetic code so we could see what was in the virus and figure out why I was falling into paralysis. It took OSHA around a year to make a ruling-it went from Hartford to Boston to Washington D.C.-and they ruled that protection of trade secrets supersedes my right to get any genetic information on this virus.

That's an OSHA rule?

That was their interpretation. The OSHA law was really made for chemicals, but they're trying to apply it to biological agents, which is a little bit ridiculous.

Think about the implications for the public if workers can't get their exposure records to get medical care. You need the genetic code for medical care. Basically what you need are the cloning, sequencing and production records. The cloning records show how you make the vector, whether you're putting in a toxin, a genetic missile, or just a green fluorescent protein. This should include the sequencing records so you know that the sequence is correct. Then you need the production records. This is the part of the experiment where they take the vector that they've just cloned and they make it infectious. That's important for two reasons: first, how did they make it infectious; and second, did they test for the possibility of recombination so the virus can replicate.

You need all of these things, and I call my case the perfect storm because they couldn't snowball me. OSHA doesn't have the expertise, but I knew you needed all of these things.

OSHA called me up and told me that by law they could not assist me in obtaining the appropriate exposure records that I had requested. They said that I had to work with Pfizer and that Pfizer had agreed to give me the sequence of the viruses if I would get an attorney [to draw up a confidentiality agreement]. One of the problems that injured biotech workers have is that it's difficult to find an attorney. These are new laws, and no attorney wants to pick up a high-risk case like biotech workers. You're establishing precedent in the field, and the technology is very advanced, so the cost of litigation is very high. There are a lot of people in my same situation - not necessarily only in biotech, but there are people getting injured at work who can't find attorneys. They lose their jobs, they lose their homes ... it's really a serious issue.

It was for me too. I couldn't find an attorney. I had one, but he told me it was too complex and he couldn't help me anymore. Finally I found Bruce Newman, in my little hometown of Deep River, and he helped me for a long time.

We were able to draw up a confidentiality agreement, and I got a sequence - but it's not even a complete version of the virus. They give me this chopped up virus, and it looks like it contains errors, so I know it's a rough draft. It's still good enough that I can decode it and try to learn the function of the virus, but it's not appropriate for medical testing because it's not a finalized sequence. It's like the early rough draft of a book-you can read through and see what it's going to be about, but you can't publish it because it's full of misspellings and errors.

And listen to what I found: the virus contained a genetic missile that destroys three potassium channels and two neurotransmitters. And I've been diagnosed with a potassium-sensitive paralysis. There's the etiological link.

Still, this was from a rough draft sequence-it wasn't enough for medical testing. When biologists get exposed, they should have the right to get not just medical care, but also full disclosure of their records.

Do you feel hopeful at all that these rules could actually change, that workers could be allowed their exposure records?

There's an act in Congress called the Protecting America's Workers Act, and there's no provision in it to give employees the right to adequate exposure records for their medical care. So no, I have no hope at this point that it's going to change, since it's not in that act.

One of the problems is that there are other people this has happened to and they can't get any legal remedy. What agency is collecting data on injured biotech workers? What I'm seeing is that any incident in biotechnology is being hushed up. I think it's the biotech industry, the pharmaceutical industry, and really the scientific academic industry that do not want these things to come out. They think the public will be terrified.

Though I'm not sure it's "We don't want the public to be terrified" so much as "We don't want the public to be terrified of us."

Sure, there's self protection involved. What I saw at Pfizer, how out of control it was - there is grand potential for agents to be released into the environment.

When I went to worker's comp-because you have to go to worker's comp, they force you into it-I asked for my exposure records, and worker's comp said they don't have jurisdiction. That was it. What am I going to do without exposure records?

Then while in Worker's Comp we disclosed that I had been diagnosed with transient periodic paralysis and that we could show a causal etiological link between my condition and the Pfizer lentivirus involved in my exposure. Right after that disclosure, Pfizer wrote us a letter saying, "We're sorry, we accidentally sent you the wrong virus," and they sent sequencing for a different virus without that etiologicial link. When I asked them to send the cloning and production records to show this was the right virus, they said they didn't have those records anymore.

In your experience there, would it have been the case that those records would just disappear?

No, no, no. Can you imagine if they didn't have records of how they made human infectious agents? It's a public safety issue. This type of record keeping is standard practice in scientific research.

It doesn't seem like it would be any better for them to have the records and claim they don't than to not have the records at all.

They're both bad. There's no way out of this: it looks bad for Pfizer both ways. It shows disregard for public health and safety and for worker's healthcare rights not to have or produce those records. But it was in their best interest to play that card since it shelters them from any further legal claims as it did in my case.

This is a public health and safety issue. It's great that I won my case on freedom of speech, but this other claim, trying to get my exposure records, is very serious too, and there's no avenue available to pursue it.

Biotech workers had better watch out. The best thing is to take safety very seriously and prevent these things from happening. The problem is, at Pfizer we were trying to prevent them from happening-and we were told to shut up. If it happens at the wealthiest pharmaceutical company in the world, it can happen elsewhere.

RETROVIRUSES, GENETIC ENGINEERING & PUBLIC & WORKER SAFETY

GIVE THEM AN INCH... "Pfizer's head of biosafety, Dr. Eric Utt, admitted that no risk assessment had been conducted on the potentially dangerous lentivirus experiment conducted in Mrs. McClain's workspace-or, in fact, for lentivirus experiments in general."


http://www.councilforresponsiblegenetics.org/GeneWatch/GeneWatchPage.aspx?pageId=251

GIVE THEM AN INCH...

By Michael Siciliano

I was scheduled to appear as an expert witness at Becky McClain's trial against Pfizer. My testimony was to be that the symptoms of Mrs. McClain's illness were consistent with her being exposed to a virus being worked on in the laboratory. In the judge's opinion, the lack of physical evidence relating any such exposure to the disease was considered insufficient and the related count was thrown out. However, I was confident that I could testify on biosafety issues-I am well practiced in the art of biosafety, having run a molecular genetics and cell biology laboratory for over 35 years in which biosafety considerations were carefully met. I did have concern about how flawed Pfizer's biosafety practices could really be.


Pfizer claimed that Mrs. McClain was terminated for not returning to work after she took a leave due to her illness; Mrs. McClain said that she was fearful about returning to work because of the lax and dangerous biosafety practices at Pfizer. I could not imagine that Pfizer was lax in that area because a former Pfizer research director I knew assured me that the Standard Operating Procedures for Pfizer were to follow the National Institutes of Health guidelines for biosafety when dealing with recombinant DNA activity.


I was shocked to learn that Pfizer's own guidelines for appropriate procedure, as well as NIH guidelines, were not followed in Mrs. McClain's department and that she had a real basis for her fear in returning to work. In some cases the lack of safety standards appeared to be due to ignorance and in others it appeared to be due to an apparent flagrant disregard for world-recognized appropriate procedure.


The problem proved to be systemic: Pfizer's head of biosafety, Dr. Eric Utt, admitted that no risk assessment had been conducted on the potentially dangerous lentivirus experiment conducted in Mrs. McClain's workspace-or, in fact, for lentivirus experiments in general. Why would no risk assessment be done when it is such a fundamental procedure before initiating any such experiments with potentially biohazardous material as a lentivirus? Dr. Utt answered that such assessment is already done on the kits they get that contain the reagents for the experiment. This is a monstrously frightening statement, coming from one at such a lofty position in the organization with respect to biosafety.


So what's the big deal?


The lentivirus which McClain was exposed is a retrovirus. This means its genetic code is in the form of RNA rather than DNA. The RNA is in a "coat" which enables it to attach to a broad spectrum of mammalian cells and become engulfed in the cell. As described by the late brilliant Nobel-prize winning molecular geneticist Howard Temin, the virus has a gene (called reverse transcriptase or RET) which enables it to go backwards in the genetic paradigm. Normally, the DNA code for a gene creates an RNA message which directs the formation of the protein specified by the gene. RET makes it possible to go backwards, making DNA from the RNA. The viral DNA can then be inserted into the DNA of the chromosomes. New gene insertion with long term effects becomes possible, depending on what the virus has been designed to do. The gene therapy possibilities are intoxicating to drug companies and biomedical research. We can expect increased intensity in this field in the near future.


Temin suggested that making the virus replication deficient might be a safe form of gene therapy. However, we have now learned that a replication deficient virus, such as what Pfizer was using, can recombine with other viruses in its environment, or in the cell into which it is transduced, to become competent. From there it can replicate itself millions of times and create severe disease scenarios.


That is not the only problem these genetically engineered viruses can cause. Upon insertion into host cell DNA the virus can cause mutations at the sites of insertion that lead to cancer. These events, including recovery of replication competence, have been described in monkeys and in humans undergoing initial gene therapies, resulting in approximately 30% of subjects treated dying of lymphoma.


In a proper Risk Assessment, one needs to determine not only the genes in the virus being used, but also the spectrum of infectivity of its coat as well as the concentration of the virus being used. It is also necessary to consider the mammalian cells being transduced. They may be harboring other viruses in various cellular regions or have their sequences integrated into its chromosomes. These are all targets for recombination which can generate a replication-competent virus. Such issues cannot be addressed in a commercially available reagent kit disclaimer since the specifics of the virus, its concentration, and cells into which they are being transduced are not considered. These parameters need to be articulated in a Risk Assessment sent to the Institutional Biosafety Committee, which needs to give final approval for the experiment depending on its perceived risk/benefit ratio and indicating the conditions under which such an experiment can be performed. That is the only acceptable NIH approved procedure.


Later I had the opportunity to speak with Dr. Utt. I told him that he needed to know that his Risk Assessment was not consistent with NIH guidelines on biosafety. He smiled and said that Pfizer was not bound to follow NIH guidelines.


He was right. An academic institution must follow NIH rules or lose their funding for their projects-all the projects at the institution. Drug companies don't get NIH funding, so their guidelines are as effective as traffic signs in Italy: mere suggestions.


The time has come for new law. The number of biotech workers is growing, and we can expect increased involvement from big pharma. Workers need legal rights to obtain disclosure of the identity of the biological agents to which they are exposed in order to obtain directed medical care. Unless biotechnology labs are brought under appropriate regulation, severe threats persist for the welfare of workers in the industry as well as the general public.

Michael J. Siciliano, Ph.D., D.Sc.(hon), was Kenneth D. Muller Professor of Tumor Genetics (Ret.) at The University of Texas M.D. Anderson Cancer Center.

SAFETY RULES CAN'T KEEP UP WITH BIOTECH INDUSTRY

                                    Becky McClain
                            Wendy Carlson, NYT Photographer

NEW YORK TIMES
http://www.nytimes.com/2010/05/28/business/28hazard.html?hp

                                      
May 27, 2010

Safety Rules Can’t Keep Up With Biotech Industry

By ANDREW POLLACK and DUFF WILSON

They are the highly trained, generally well-paid employees in the vanguard of American innovation: people who work in biotechnology labs. But the cutting edge can be a risky place to work.

The casualties include an Agriculture Department scientist who spent a month in a coma after being infected by the E. coli bacteria her colleagues were experimenting with.


Another scientist, working in a New Zealand lab while on leave from an American biotechnology company, lost both legs and an arm after being infected by meningococcal bacteria, the subject of her vaccine research.


Last September, a University of Chicago scientist died after apparently being infected by the focus of his research: the bacterium that causes plague.


Whether handling deadly pathogens for biowarfare research, harnessing viruses to do humankind’s bidding or genetically transforming cells to give them powers not found in nature, the estimated 232,000 employees in the nation’s most sophisticated biotechnology labs work amid imponderable hazards. And some critics say the modern biolab often has fewer federal safety regulations than a typical blue-collar factory.


Even the head of the federal Occupational Safety and Health Administration acknowledges that his agency’s 20th-century rules have not yet caught up with the 21st-century biotech industry.


“Worker safety cannot be sacrificed on the altar of innovation,” said David Michaels, OSHA’s new director. “We have inadequate standards for workers exposed to infectious materials.”


The current OSHA rules governing laboratories, for example, were not written with genetic manipulation of viruses and bacteria in mind. “The OSHA laboratory standard deals with chemicals,” Mr. Michaels said. “It doesn’t deal with infectious agents.”


Earlier this month, as a first step toward possible new regulations, the agency issued a sweeping request for information on occupational risks from infectious agents, and for suggestions on how best to reduce them. The focus is mainly on hospital and other health care workers, but any rules are expected to also cover industry laboratory workers.


Some safety experts in the biotechnology industry argue that there is no big safety problem, and that workers are adequately protected by various voluntary guidelines on safe laboratory practices and by OSHA’s general rule that employers provide a safe workplace.


“The OSHA requirement applies to all industries, including the pharmaceutical industry,” said John H. Keene, a biosafety consultant to industry and former president of the American Biological Safety Association, a professional society for those involved in biolab safety.


But at least three trends are stoking concern among safety advocates. In the wake of the 2001 anthrax attacks, the federal government stepped up research involving biowarfare threats, like anthrax, Ebola and many other of the world’s deadliest pathogens. Another factor is that the new techniques of so-called synthetic biology allow scientists to make wholesale genetic changes in organisms rather than just changing one or two genes, potentially creating new hazards. Just this month, the genome pioneer J. Craig Venter announced the creation of a bacterial cell containing totally synthetic DNA, which Dr. Venter described as the first species “whose parent is a computer.”


The third trend involves the shifting focus of the pharmaceuticals industry — potentially the largest source of new biotechnology jobs. Drug makers, responding to competition from cheap generic medications, are moving beyond the traditional business of making pills in chemical factories to focus instead on vaccines and biologic drugs that are made in vats of living cells.


There are currently few good statistics on biolab accidents. One study, reviewing incidents discussed in scientific journals from 1979 to 2004, counted 1,448 symptom-causing infections in biolabs, resulting in 36 deaths. About half the infections were in diagnostic laboratories, where patient blood or tissue samples are analyzed, and half in research laboratories.


But that may be a “substantial underestimation,” the study’s authors wrote, because many incidents are never made public. The study was done by two biosafety experts and published in the book “Biological Safety: Principles and Practices.”


A survey done by the Bureau of Labor Statistics in 2006 found that the rate of workplace injury and illness in corporate scientific research laboratories was well below the average for all industries. The survey included labs in industries like information technology as well as biotechnology, and excluded labs handling the most dangerous pathogens.


Allegations about a more recent case came to light only through a lawsuit. It was filed against the drug giant Pfizer by Becky McClain, a former molecular biologist at the company’s largest research center, which employs 3,500 people in Groton, Conn.


Ms. McClain, now 52, says she has suffered bouts of temporary paralysis after being infected by a genetically engineered virus at the Groton lab. A jury last month awarded Ms. McClain $1.37 million, saying Pfizer had fired her for raising questions about laboratory safety.


Pfizer said it went to considerable effort to accommodate Ms. McClain and dismissed her for refusing to return to a safe workplace. The company also pointed out that OSHA had found that Ms. McClain was not fired for raising safety concerns. But the jury ruled otherwise, saying Ms. McClain was indeed fired for raising safety concerns of public interest.


The jury never actually addressed whether a workplace virus had made Ms. McClain ill, because the judge threw out that claim, in part for lack of evidence. Mr. Michaels, the OSHA director, declined to comment on the McClain verdict, but said the issues under dispute in her case underscored the gaps in regulatory protection for lab workers.


For almost all private businesses, OSHA requires employers to report workplace deaths and serious accidents. But the information is usually kept in-house by employers and given to OSHA only if requested during an annual spot check of 80,000 companies — a small fraction of the approximately seven million employers bound by OSHA regulations.


Moreover, OSHA does not have jurisdiction over many academic and government biolabs, where there have been dozens of known cases of worker illness or at least exposure to harmful agents.


Many laboratories in both the public and private sectors adhere to practices in a safety manual published jointly by the Centers for Disease Control and Prevention and the National Institutes of Health. Employees of government biolabs and others that receive federal research grants for genetic engineering are covered in part by stricter guidelines from the National Institutes of Health, and some companies voluntarily follow those guidelines. But other private industry workers are dependent on OSHA.


Mr. Michaels said that rather than trying to establish new rules for each infectious agent or for any specific hazards, he expected OSHA to eventually require employers, in consultation with their employees, to identify all potential hazards in their workplaces and to take steps to reduce them. OSHA would then have the power to cite employers for failure to adequately implement this process.


“OSHA has 2,000 inspectors for 130 million-plus workers in seven million workplaces,” Mr. Michaels said. “We can’t take them on one at a time.”


Despite the fact that some worker advocates are pointing to Ms. McClain’s case as representative of broader problems, they are hard pressed to cite other examples of workers in biotechnology companies being harmed.


But these advocates contend that the reason more cases in private industry are not coming to light is that current rules do not put enough pressure on companies to report them. And OSHA’s general safety requirement is notoriously difficult to enforce.


“We don’t know how many Becky McClains there are,” said Adam M. Finkel, who worked for OSHA both as a regional administrator and a director of health standards. “Everybody knows there’s new stuff being made every day that’s incredibly dangerous, but nobody knows how to get their arms around it.” 

ANOTHER BIOTECH WORKER SICKENED WITH INFECTIOUS AGENT

Wednesday, May 19, 2010

ANOTHER LABORATORY BIOSAFETY CASE - BIOTECH WORKER SICKENED WITH DANGEROUS INFECTIOUS AGENT

In light of all the recent biosafety issues, another biotech worker has become infected by an infectious microorganism while working in an infectious disease laboratory at University of Wisconsin-Madison. The University has been fined and a Professor of Infectious Disease has been punished by removal of his laboratory privileges.


University of W-Madison Professor Gary Splitter worked on Brucella, a microorganism which can cause Brucellosis, a major zoonotic disease. The disease can infect animals and can also cause a contagious disease in humans. Brucella is considered a bioterrorist agent. A biotech worker had become infected while working in Splitter's laboratory.


The Wisconsin State Journal states: "His lab created antibiotic-resistant strains of brucellosis and inserted them into mice in 2007 and possibly earlier, university officials said, without approval from local or federal agencies. The concern is that if someone contracted the antibiotic-resistant version of the disease created in the lab, treatment might have been more difficult." "


Splitter will lose his laboratory privileges for five years due to this serious biosafety incident and since his laboratory was not within recombinant DNA NIH standards. The university was fined $40,000 for their role also in violations of laboratory and public health and safety standards.


Biosafety is a current worker safety and public health and safety issue. Injured biotech workers can remain ill and untreated in the United States since diseases from genetically modified organisms or laboratory strains are difficult to diagnose. In addition biotech workers have no legal rights to appropriate exposure records for treatment after incurring an exposure.


Although academic labs such as University of Wisconsin are mandated to follow NIH guidelines, private industry is under no such constraint, leaving a big gap in public health and safety standards.


The biotech worker in Splitter's lab who became infected with Brucella remains unidentified.
http://watchdogonscience.blogspot.com/2010/05/another-biotech-worker-infected-and.html


Creating antibiotic resistant germs in a laboratory supposedly has relevance in respected authorized research, however, could there be accidents and could these modifed pathogens escape from the laboratory environment and cause pandemic outbreaks which appear to be resistant to antibiotics? There is much controversy over the validity of long term treatment in Lyme disease. The Lyme pathogen has various ways of avoiding our immune systems and antibiotics. Could this stealth quality have been created in a lab? Check out the link below to try and determine how long they have actually been working with the Lyme disease pathogen. In several government documents, this pathogen has been classified among potential biowarfare agents....as is the brucella organism.
http://lymesentinel.blogspot.com/2008/10/can-lyme-disease-be-acquired-through.html

To learn more about where Lyme disease...or a certain form of Lyme disease, may have originated, read
Lab 257: The Disturbing Story of the Government's Secret Plum Island Germ Laboratory

A DAY TO FIGHT FOR THE LIVING

http://watchdogonscience.blogspot.com/2010/04/workers-memorial-day-day-to-fight-for.html


Worker’s Memorial Day, a Day to Fight for the Living


By Becky A. McClain, April 27, 2010

On April 28th people around the globe gather to commemorate Worker’s Memorial Day. It is a day to remember those who lost their lives at work, but also a day to fight for the living, to continue to advocate for injured workers, to advocate for safe work environments and to protect public health and safety.

I am Becky McClain, a former scientist, a whistleblower, and an injured biotech worker who acquired an illness after a work-related exposure to a genetically engineered virus at Pfizer


My case is unique in some ways and not so unique in others.


It is not unique in ways where history seems to whisper her stories. …Stories told where corporations can often prioritized “bottom lines” over workplace safety. …Stories that tell a tale about workers being intimidated to raise safety issues for fear of losing their job or position, and where workers must work in unsafe work conditions. …and stories about injured workers who are subsequently terminated, abandoned and ill, with no place to turn.


But my case is unique in other ways. Most notably because it involves the world of recombinant DNA, a world where new genetically engineered infectious agents are being created almost every day in our neighborhood university research labs and private biotech and pharmaceutical companies throughout the United States. It is unique because unsafe laboratory practices can not only harm workers, but also could impact the public’s health by creating new emerging disease and new chronic illness.


Dangerous public health and safety-related issues in the biotech field are real, not only relating to my story, but also, for others around the country. This past year Dr. Malcolm Casadaban, a Professor of Molecular Genetics from the Univ. of Chicago died after a work-acquired infection to Yersinia pestis, the bacteria linked to the plague, a bacterium that had been laboratory-attenuated, disabling its ability to cause disease. Unfortunately, that latter fact turned out to be unknowingly wrong. Dr. Casadaban’s death brings to light the unprecedented dangers which biotech workers face and which the public should be made aware.


Dangers in the biotech field have personally impacted me also. Consequently, for the past six years I have been fighting work-related legal battles for my health and to advocate for public health and safety. Through these struggles, I have learned that the biotech industry holds very little protections for workers. For example, biologists have no legal rights to have safety issues addressed formally at work, even if issues are of a public concern. In addition, biotech workers who are inadvertently exposed to genetically engineered infectious agents at work, have no healthcare rights and no legal remedy for an illness which may subsequently develop.


So although that I am overjoyed to have recently won a federal lawsuit against Pfizer in violation of my whistleblower rights and my free speech for public health and safety, I am disappointed and concerned to still have no legal remedy regarding Pfizer’s failure to provide the appropriate exposure records necessary for my healthcare, even after doctors’ requests.


And what is most concerning is that no other worker has these rights either.


In fact, OSHA has established a ruling in my case that “trade secrets” supersede a worker’s right to obtain appropriate exposure records upon a biological exposure….records, I may add, that are necessary for directed healthcare.


This is a terri ble situation and provides a horrific precedent for all biotech workers and other workers exposed to any type of biological agent while at work. Not only does this ruling increase the likelihood that injured biotech workers will not receive directed medical care, but it also helps conceal the actual work-related biotech injuries from the public’s eye. In addition, since workers could possibly become infectious through an exposure at work, it raises serious public health and safety issues.

I personally would never have imagined that this type of worker rights issue and human rights issue would have even been possible in America .


These issues provide glaring examples where we must fight for the living. Workers who incur a biological exposure should have the right to obtain full disclosure of the exposure information necessary for directed healthcare. And companies, like Pfizer, who do not disclose or keep adequate exposure records on infectious agents they create, should be severely penalized. In addition, scientists should have legal rights and a formal structure to address health and safety issues on the job. Finally, our broken Worker Compensation system leaves many injured workers destitute and abandoned. It needs to be revamped and strengthened to provide timely and appropriate healthcare for all injured workers, including those who acquire illness. These initiatives, to fight for the living, not only provide for a safe work environment, but also, protect and benefit the public.


Today on Worker’s Memorial Day we reflect on all of those who have lost their lives at work this past year, Perhaps, we should especially remember the most recent tragedies in the United States: the 5 men who died during the Middletown Kleen Energy explosion in Connecticut, the 29 miners who lost their lives at the Massey West Virginia Coal Mine Explosion, as well as, the 11 men who lost their lives at the oil rig explosion off the coast of Louisiana. These deaths, along with the numerous serious injuries, reflect how catastrophic it can be when unsafe work conditions are ignored.


But let us not forget on this Worker’s Memorial Day also, those nameless souls who have died through work-related illness, abandoned because of no laws or legal protections. We should moreover bear in mind on this day, those currently struggling with work-related illness or injuries who suffer the same abandonment. May these men and women be also remembered in our prayers and provide a reason to fight for the living.