GeneWatch Vol. 23 No. 2

VOLUME 23 NUMBER 2 MARCH-APRIL 2010

THE MAGAZINE OF THE COUNCIL FOR RESPONSIBLE GENETICS • ADVANCING THE PUBLIC INTEREST IN BIOTECHNOLOGY SINCE 1983

FEATURES Ralph Nader on Pfizer’s biolab safety mess GeneWatch exclusive: Becky McClain fights for her worker’s rights GM crops: National Research Council misses the mark

GENEWATCH MARCH-APRIL 2010 VOLUME 23 NUMBER 2 & DESIGNER Sam Anderson

EDITOR

EDITORIAL COMMITTEE

Ruth Hubbard

Sheldon Krimsky

GENEWATCH is published by the Council for Responsible Genetics (CRG), a national, nonprofit, tax-exempt organization. Founded in 1983, CRG’s mission is to foster public debate on the social, ethical, and environmental implications of new genetic technologies. The views expressed herein do not necessarily represent the views of the staff or the CRG Board of Directors.

ADDRESS 5 Upland Road, Suite 3 Cambridge, MA 02140 PHONE 617.868.0870 FAX 617.491.5344 NET www.councilforresponsiblegenetics.org BOARD OF DIRECTORS SHELDON KRIMSKY, PhD, Board Chair Tufts University PETER SHORETT, MPP Treasurer EVAN BALABAN, PhD McGill University PAUL BILLINGS, MD, PhD, University of California, Berkeley SUJATHA BYRAVAN, PhD Centre for Development Finance, India ANDREW IMPARATO, JD President and CEO, American Association of People with Disabilities RAYNA RAPP, PhD New York University PATRICIA WILLIAMS, JD Columbia University

STAFF Jeremy Gruber, President and Executive Director Sheila Sinclair, Manager of Operations Sam Anderson, Editor of GeneWatch Kathleen Sloan, Program Coordinator Andrew Thibedeau, Fellow

Editorial

Sam Anderson

This may be one of the most important GeneWatch issues in recent memory. In its early days, the Council for Responsible Genetics put a great deal of effort into laboratory safety questions as Harvard University prepared to set up a recombinant DNA lab.

Today, biolab safety is still an important issue for those who live near a current or planned high security laboratory, such as Boston University’s plan to study highly pathogenic diseases in a Biosafety Level 4 lab nestled in the densely populated neighborhood of Roxbury. In this issue, we also focus on those directly in the line of fire: lab workers.

Becky McClain’s case against Pfizer is central to this issue. While a researcher in a Pfizer lab, Becky became severely ill. All of the evidence suggests that a mishandled genetically engineered virus was the culprit, but Pfizer will not release the records that could prove this—and help Becky’s doctors determine the best course of treatment.

Aside from Pfizer’s mistreatment of their own worker after she became ill, Becky’s case demonstrated how easily companies can get away with shockingly poor safety measures in labs. This was even more clear in the case of David Bell, who contracted a mysterious infection while working in a pesticide company lab where potentially hazardous experiments were conducted with only a bathroom fan for ventilation and where the researchers gathered each day for afternoon tea—not in a break room, but in the lab, among the researchers’ malaria experiments and exotic soil cultures.

At Pfizer, the hallway doubled as lunch room. Workers ate while dangerous materials were carried past, and on several occasions Becky McClain says they discovered biological samples sitting where employees ate their lunches.

Her complaints on the matter fell on deaf ears, as did David’s at his lab (he was told biohazard signs would not look good for tours). Becky compares safety hazards in biolabs to “a roach in the kitchen”—when you see one, you can bet it’s only the tip of the iceberg.

The same could be said of Becky McClain and David Bell themselves. These are not isolated incidents. Now that we have seen these two cases, one has to wonder: how many more are out there?

Featured artist COVER ART Sarah Kim

Sarah Kim is a recent graduate of Massachusetts College of Art and Design who enjoys working on any and all kinds of illusration. You can see more of her work at www.skimilkart.com.

Unless otherwise noted, all material in this publication is protected by copyright by the Council for Responsible Genetics. All rights reserved. GeneWatch 23,1 0740-973

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MARCH-APRIL 2010

Contents Dedication: Tony Mazzocchi JEREMY GRUBER

4

A Cruel and Unusual Corporation RALPH NADER

5

A Roach in the Kitchen BECKY MCCLAIN

6

AN

Pfizer’s treatment of Becky McClain exposes the company—and the need for new laws (p. 5)

David Bell got sick in a lab where a bathroom fan or an open window could stand in for a biological safety hood (p. 16)

INTERVIEW WITH

Give Them an Inch...

MICHAEL SICILIANO

10

One Bug, One Drug EDWARD J. SYLVESTER

12

The Lab in My Backyard BETH WILLIS

14

Teatime in the Lab SAM ANDERSON

16

Book Review: Breeding Bio Insecurity and Germs Gone Wild ANDREW THIBEDEAU

18

Topic: Genetic Discrimination

20

LYNN C. KLOTZ

AND

JEREMY GRUBER Topic: Forensic DNA Databanks

21

Flushing It Down the Rabbit Hole ANDREW THIBEDEAU

22

Commentary: GM Crops ERIC HOFFMAN

25

Endnotes

27

The Council for Responsible Genetics has launched a new blog: Genetic Watchdog. Watch for regular news and commentary as recorded by CRG staff, board members, and friends, and join the discussion by leaving your own comments. You don’t have to wait for the next GeneWatch to keep up with the latest events in biotechnology and ethics!

The story of the woman who stood up to Pfizer and won—round one, anyway (p. 6)

The neighbors were none too happy when Fort Detrick was converted into a biowarfare research lab (p. 14)

A new government report on genetically engineered crops falls short in assessing their sustainability (p. 25)

The blog can be found at: http://www.councilforresponsiblegenetics.org/Blog.

VOLUME 23 NUMBER 2

GENEWATCH 3

Dedication: Tony Mazzocchi

BY JEREMY GRUBER This special issue of GeneWatch magazine is dedicated to the memory of Anthony “Tony” Mazzocchi (1926-2002), a founder of the Council for Responsible Genetics and an incorruptible fighter for worker health and safety.

The son of a working-class immigrant family in Bensonhurst, Brooklyn, Tony lied about his age and went off to war in 1943 as a 16-year-old. He survived the Battle of the Bulge and was with one of the first units to liberate Buchenwald.

In 1953, at the age of 26, Tony was elected president of United Gas, Coke, and Chemical Workers’ Union Local 149, having run on a pledge of equal pay for women. Within a few years, he had not only won equal pay for equal work for women but also negotiated a health insurance plan—one which included the first dental insurance coverage in the private sector in the U.S. Tony fought against global warming and for free health care, a guaranteed income and free access to higher education.

Although Tony never finished high school, he was the prototype of the worker intellectual. He was a voracious reader, an avid student of subjects as diverse as genetics and evolution, history and politics. He produced plays and organized cultural festivals. He was widely regarded as a visionary big picture thinker who was in the forefront of the labor movement’s involvement and bridge-building to the major struggles for social justice in the postwar period— from the civil rights and feminist movements and the struggles against nuclear proliferation and the Vietnam War, to the fights for environmental justice and the movement for occupational health and safety, which he spearheaded.

Long before the environmental movement in the United States had even begun, Tony began integrating environmental concerns into his critique of capitalism and his union work. As he discovered that corporations were exposing workers to toxic, even lethal substances in the rush for profits, he grew to believe that the inherent struggle between capital and the natural environment was the defining struggle of his time. He regularly questioned why even good paying jobs sentenced workers to so many occupa-

4 GENEWATCH

tional illnesses. He would thereafter work not just to protect workers against toxic substances but to eliminate such toxins as part of a broader green movement. As his protégé and biographer Les Leopold writes, “Mazzocchi’s conceptual breakthrough was that pollution always starts in the workplace, and then moves into the community and the natural environment.”

It is not an exaggeration to say that without Tony Mazzocchi, the occupational health and safety movement would not have begun, the environmental health movement would not have begun and a new profession of occupational health would not have begun. In 1965, Tony was appointed as the Oil, Chemical, and Atomic Workers International Union’s Citizenship-Legislative Director. He used his position to push heavily for health and safety language in union contracts as well as for state and federal legislation on the issue. In 1969 and 1970, he organized a series of public meetings in which OCAW and other union members testified about the chemicals they were handling and the health problems they were experiencing. Scientists also testified at these public hearings about the danger of these chemicals. The public meetings gained widespread press attention. Tony also used the hearings to help educate workers on the legislative process, and trained them to act as lobbyists for federal health and safety legislation. The media attention and pressure from union members provided critical support for congressional attempts to pass comprehensive occupational health and safety legislation. In December 1970, Congress enacted and President Richard Nixon signed the Occupational Safety and Health Act. Nixon specifically cited Tony’s leadership and grassroots organizing efforts as key in winning passage of the Act. Even after passage Tony worked incessantly to improve worker health and safety protections, particularly for asbestos related exposure in the workplace which resulted in vastly improved standards. He was an important figure in the “right to know” movement, which advocated for rules, regulations and legislation to give individuals the right to

know which chemicals they may be exposed to while on the job. Tony went on to become Vice President of OCAW and under his leadership, OCAW became the rare union to call major strikes at big companies solely around issues of workplace health. And it was Tony who encouraged a young lab technician on the bargaining committee at the KerrMcGee nuclear facility in Cimarron, Oklahoma, to pursue her suspicions that X-rays were being doctored to disguise cracks in control rods that leaked plutonium. After David Burnham of The New York Times got on the case, the young nuclear technician, Karen Silkwood, en route to give Burnham a folder of documents, was found dead in a mysterious car accident.

Tony went on to found the Labor Party, but his unwavering dedication to worker health and safety would continue to dominate his work. He had a seemingly endless optimism to create change and he always viewed his work as a collective endeavor. Indeed, Tony touched nearly everyone he met, educated them and inspired them and hundreds of organizers cherish Tony as the most personally generous of mentors. Tony led a life of struggle for something much bigger than himself. He laid the groundwork for a healthier and fairer America, and for that we are all greatly indebted.

Jeremy Gruber, J.D., is President and Executive Director of the Council for Responsible Genetics.

MARCH-APRIL 2010

A Cruel and Unusual Corporation

BY RALPH NADER

Why would Pfizer, the world’s largest drug company, so mistreat and silence one of their top molecular biologists that a federal jury in Connecticut awarded her $1.37 million in damages last week? And why, when Pfizer refused to reveal what biohazards the scientist might have been exposed to, would the Occupational Safety and Health Administration throw up its hands and claim it had no mandatory disclosure authority in such cases?

The unraveling answer promises to tear open the curtain covering hazards confronting tens of thousands of scientists and assistants in corporate and university labs doing genetic engineering work with viruses and bacteria.

Becky McClain’s lawsuit against Pfizer claimed that the company’s sloppiness in 2002-03 exposed her to an engineered form of the lentivirus, a virus related to one that could lead to immune deficiencies. Pfizer denied any connection between its lab practices and Ms. McClain’s recurring paralysis and other illnesses.

Back and forth over three years came the scientist’s claims and Pfizer’s denials during which she had to leave her job amidst the increasing retaliatory behavior of her ten-year employer.

Pfizer is known for playing hardball and violating laws. Last year it had to pay the Justice Department one of the largest fines – half civil, half criminal— for illegal promotion of its drugs for unapproved uses. The fine—$2.4 billion— prevented criminal charges and prosecution, either of the company or officials, and became just another cost of doing business.

In April, soon after buying Wyeth Labs for $68 billion, Pfizer’s CEO, Jeffrey B. Kindler, told a reporter for The New York Times that his company has “invented too few drugs and left its reputation in disrepair after two criminal cases.”

That record does not diminish Pfizer’s advantage over its imperiled lab workers, which is built on the absence of any available risk assessments, the very nature of possible latent, silent violence, and the cruel refusal to give afflicted employees their own exposure records

VOLUME 23 NUMBER 2

on the grounds that they are company trade secrets.

Pfizer offered Ms. McClain a paltry sum with a gag order, which she promptly refused. She wanted her freedom of speech and her whistle-blowing rights under federal law. Her lawsuit was filed in 2006 in Hartford.

Yet while Pfizer was found to have violated Ms. McClain’s right to free speech and her whistleblower rights, U.S. District Judge Vanessa L. Bryant dismissed Ms. McClain’s claim that her illness resulted from Pfizer’s wanton misconduct. The judge ruled that the plaintiff did not have available the evidence of causality and it was a worker’s compensation matter anyway. Herein started the chicken-egg problem. The evidence in question rested in Pfizer’s secret records, which would show what biohazards Ms. McClain had been exposed to in the lab; yet, in refusing to give Ms. McClain this information, Pfizer claimed—and OSHA accepted without intercession—that the exposure records were protected as trade secrets.

Becky McClain has already exhausted any remedies or assistance from the woeful Occupational Safety and Health Administration. This agency has been without any regulations or disclosure requirements about biohazards in laboratories. This inertness might change with the appointment of David Michaels to head OSHA, which should bring the agency closer to its mission of preventing or diminishing tens of thousands of fatalities and injuries each year.

Mr. Michaels told the Times that “new biological materials, nanomaterials, there are many things where we don’t have adequate information, and we think workers need to have protection.”

He indicated that OSHA will take another look at the McClain case.

Both Jeremy Gruber, president of CRG, and Steve Zeltzer, chair of the California Coalition for Workers Memorial Day, believe the McClain case will lead to broader scrutiny of biologic laboratories, where research is expanding rapidly with heavy federal funding.

It is well known that workers in these labs are inhibited from speaking out, either inside or outside their workplace,

for fear of losing their jobs. OSHA has long known that companies in old and new industries often do not come close to fully reporting cases of their injuries and sickness either to their insurers or to state or federal job safety agencies.

Some have been found to keep two sets of books.

The Bureau of Labor Statistics data are not at all comprehensive. Underreporting can hide half or three-fourths of the actual traumatic injuries.

Mr. Zeltzer has denounced what he calls “the failure of top company officials to even report to OSHA and other government agencies that many workers were getting sick numerous times in their laboratories although this is required by the law.” He called on the US Attorney in Hartford to begin a criminal investigation. (see workersmemorialday.org) As for Becky McClain, this is just the end of the beginning. She says she has lost her career, her health and her health insurance. But she recognizes her case is in the vanguard of many other cases and worker protests to come before enforceable and openly accessible standards and practices become the way of doing business for these labs.

For when it comes to developing materials that are inherently latent, subvisible forms of silent violence, business as usual can become cruel and unusual punishment for innocent, defenseless scientists, lab technicians and other workers.

Such is the weighty responsibility of David Michaels and the new managers of the long moribund, underfunded OSHA in the coming months.

Ralph Nader has founded many citizen groups in consumer, worker and environmental protection. He is the author of “Only the Super-Rich Can Save Us!,” a work of fiction.

GENEWATCH 5

A Roach in the Kitchen How Becky McClain took on Pfizer - a warning and an inspiration for biotech workers

Photo: Guillaume Goyette

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 6 GENEWATCH

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 MARCH-APRIL 2010

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

“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.” 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

VOLUME 23 NUMBER 2

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

GENEWATCH 7

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 8 GENEWATCH

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

MARCH-APRIL 2010

The Case of Dr. Malcolm Casadaban

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,

In September of 2009, Malcolm J. Casadaban, a molecular genetics professor at University of Chicago, died from exposure to a form of bubonic plague, only 12 hours after he was admitted to the hospital. Dr. Casadaban had been studying Yersinia pestis, or septicaemic plague; however, university officials maintain that the strain had been weakened to make it safe for research.

The source of Dr. Casadaban’s illness was not discovered until too late.

The revelation that he had died from exposure to the same plague bacteria he had studied for eight years led to a slew of questions. If the bacteria was supposed to be safe for research, how could this have happened? After eight years of studying the bacteria, why

did Dr. Casadaban only contract it now? And if he contracted the disease in the laboratory and then went out into the world, might others have caught it?

The Centers for Disease Control and Prevention are investigating the incident along with the University of Chicago, but details about Dr. Casadaban’s death and his experiments have been held tightly by the University, even from his own family.

Dr. Casadaban’s family is still trying to learn what led to his death, and answers from the University and the CDC have remained far from forthcoming. One can hardly help but wonder: are the investigators stumped, or is there something they are keeping to themselves?

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.

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

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

continued on page 24

VOLUME 23 NUMBER 2

GENEWATCH 9

Give Them an Inch Why don’t private biolabs like Pfizer’s live up to the National Health Institute’s guidelines? Because they don’t have to.

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 appar-

10 GENEWATCH

ent 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 Nobelprize 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

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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

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

“Drug companies don’t get NIH funding, so their guidelines are as effective as traffic signs in Italy: mere suggestions.”

Photo: Esther Simpson

VOLUME 23 NUMBER 2

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

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.

GENEWATCH 11

One Bug, One Drug Misguided bioweapons policy spurs construction of a high security biolab in Boston

BY LYNN C. KLOTZ AND EDWARD J. SYLVESTER

The heavily populated Boston neighborhoods of Roxbury, South End and South Boston may soon share their home territory with some of the world’s deadliest pathogens—the latter in a controlled environment, of course —for reasons that made little sense seven years ago when proposed and make utterly no sense now by failing to adapt to new National Institutes of Health perspectives on high biosecurity-level research.

Boston University intends to locate its National Emerging Infectious Disease Laboratory and its top-level BSL-4 lab—funded by NIH—in Roxbury.

The seemingly laudable goal stated in its title is to prevent or counter emerging infectious diseases. But the reality is they will be working mostly with bioweapons agents such as Ebola, Marburg and other nasty viruses.

Roxbury citizens have been up in arms against this idea from the start, and lest they seem to be motivated by a misguided “NIMBY” attitude, they have had the active support of groups ranging from Nobel laureates to local law firms and public interest groups.

Opposing citizens summarize their concerns better than we could in leading off their website: “The lab would pose catastrophic health and safety risks to the Greater Boston Area, create a potential terrorist target, undermine public health by diverting research funds to military purposes, [and] operate without community or public oversight ….”1 How did BU get to this place? The

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enterprise is in many ways a creature of the 2004 Bioshield act, which provided funding to such high biosecurity level labs to purchase drug and vaccine countermeasures against biological weapons, and that target, rather than emerging natural pathogens, was its primary aim. Either way, the research will be hobbled by four words inserted by the crafters of the legislation that are much like a contractual “poison pill,” virtually guaranteeing that most countermeasures developed there—or anywhere else—will never do most of us any good at all.

The language in Bioshield strongly suggests that the developed countermeasures have “no significant commercial market.” The purpose of that strange proviso was either to prevent commercial firms from using public Bioshield money to create drugs from which they would profit, or for a different sinister reason: to appease the big drug companies who may not want the government to pay for countermeasures that would compete with their marketed products. This led to the concept known in the biodefense community as “one bug, one drug”: If you design a drug to cure anthrax, it must not be of broader spectrum, able to be used against other pathogens. If against plague, it must cure only plague.

Problem: not one of the most feared Category A bioweapons agents is a public health threat in the United States. They are minor threats even in their “home” countries. The horrorshow hemorrhagic fever virus Ebola?

Less than 50 deaths a year on average and 300 in the worst years in Africa,

zero in the U.S. The same for Marburg.

Compare that to the death toll from malaria of more than 800,000 or from AIDS of more than 1.4 million in Africa alone, year in, year out. Even in Africa, the death toll and range of the hemorrhagic fever viruses is unchanging, so they should be classified as rare, not emerging, unless that changes.

The problem is that deliberate attacks that kill thousands are terrifying and demand immediate response.

A biological weapons attack that killed 18,000 of us could launch a war and would certainly bring the massive response of 9/11. In fact, terrorists don’t have the resources to launch such a bioweapons attack, and a hostile nation would be afraid to do so because of that guaranteed counterpunch, so it is of such low probability it does not merit the enormous financial resources we have thrown at it. Yet 18,000 is the number of Americans who now die every year from Staph infections, a number that is increasing because of the widely feared MRSA, methicillin resistant Staphylococcus aureus.

But wait. Isn’t there some way to cover both aspects of the biological threats we face, bioweapons and emergent natural pathogens? There is, and that strategy has been here all along, as we and many others have been arguing for years. Recently, the NIH’s National Institute of Allergy and Infectious Diseases embraced it: “Although the focus of this updated Strategic Plan continues to be on basic research and its application to product development, there

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is a shift from the current ‘one bug-one drug’ approach toward a more flexible, broad spectrum approach. This approach involves developing medical countermeasures that are effective against a variety of pathogens and toxins, developing technologies that can be widely applied to improve classes of products, and establishing platforms that can reduce the time and cost of creating new products.”2 Given its name, you might think that Boston’s National Emerging Infectious Disease Laboratory would be ahead of the game. Apparently not. Its website recently identified “some of the organisms that will be studied.” Five of the seven listed are Category A bioweapons agents, all except one causing rare diseases. Presumably this proferred list is representative. Biodefense vaccines appear to be the major focus, and vaccines inevitably have such drawbacks as questionable efficacy when they can’t be tested in humans and short shelf-life.

Finally, there’s “one drug” against “one bug.”

Even if successful, a vaccine would work against only one bioweapons agent, sometimes against only one strain. Witness the need for new vaccines each year for the annual flu to envision the chances of failure in the moment we may desperately need it.

By contrast, the broad-spectrum approach to antibiotic and antiviral drugs would immediately apply to public health and to biodefense. More important in the long term, this new strategy also calls for new platforms for rapidly developing vaccines and countermeasures for new or emerging viruses and bacteria. The zero-sum game of biodefense versus public health can become a clear win-win.

BU’s apparent stuck-in-the-past strategy that requires regular use of aerosols and a BSL-4 lab is not merely money-wasting but also dangerous,

VOLUME 23 NUMBER 2

because there are no cures or vaccines for these live viruses. Serious accidents have happened and continue to happen in the nation’s high biosecurity level labs.

The new vaccine technologies involve such strange-sounding creations as ‘bacterial ghosts’ and ‘tolllike receptors,’ but they are completely safe. None of them require live viruses or bacteria, since they make use of only non-infectious parts of pathogens. Using these technologies, experimenters can work in low biosecurity BSL-2 and BSL-1 labs without fear of becoming infected or endangering those in the surrounding community.

We believe it is clear that the Boston lab needs to be re-focused on these new, safe vaccine technologies and drugs for infectious diseases of substantial public health concern. And given its revised Strategic Plan, the National Institutes of Allergy and Infectious Disease may be amenable.

Finally, let’s address the remaining “elephant in the living room.” At the end of a vaccine or drug development project, live pathogens would be required in order to test efficacy. These end-game dangerous experiments require the highest level of biological security. If they did not, such intensive precautions as making researchers don “space suits” with external air supply and keeping labs at negative air pressure so they would suck in air, not

let it out if there is a leak, would never have been developed. Don’t such facilities have to wind up in somebody’s backyard, if not the center of Boston?

No. Here is our suggestion. Create a giant BSL-3 / BSL-4 servicing complex whose sole function is testing countermeasures against live deadly pathogens on behalf of researchers developing them elsewhere, and build it far from any population center, in the desert or on an uninhabited coastal island. In addition to the physical barriers, for added insurance those who research highly contagious viral killers and other deadly pathogens would work in days-long stints and then remain in quarantine for a short period afterward. This would cover multiple risks that are currently unattended, such as working on the live 1918 pandemic flu virus that killed 40 million people around the world and could potentially do it again if accidentally reintroduced. Against the chance of an outbreak that could kill millions this level of added protection seems to us a must.

The results would be of universal benefit. We could substantially reduce the number of BSL-3 labs scattered throughout cities—now in everybody’s backyard—and eliminate the need for all planned urban-area BSL-4 labs. That would be a big win for Boston University, too, which now is pushing for a facility that poses more potential risk than benefit for public health.

Lynn Klotz and Edward Sylvester are the authors of Breeding Bio Insecurity: How U.S. Biodefense Is Exporting Fear, Globalizing Risk, and Making Us All Less Secure, University of Chicago Press, Oct. 15, 2009. Lynn Klotz is working with scientists and Roxbury residents to propose an alternative vision for the Boston University labs.

GENEWATCH 13

The Lab in My Backyard Fort Detrick is the largest bioweapons research lab in the country - and the people living around it are not pleased

BY BETH WILLIS I moved to Frederick, Maryland in 1975, six years after President Nixon shut down the nation’s offensive biowarfare program, headquartered in Federick at Fort Detrick. Word around town was that a small Army program remained, performing research on diseases that might impact military personnel deployed around the world, but the leading message was that Fort Detrick was now home to the newest campus of the National Cancer Institute (NCI).

There were stories of course, a lot of stories, from people who had worked there and from folks who had grown up near the Fort: dead cows near the perimeter; experiments with flu virus dispersed on the population; buildings containing pathogens so toxic they would never be unsealed; researchers who died; absence of good safety practices; and Frank Olsen’s tragic and mysterious death. I thought these must be urban legends. Besides, I thought, now the Fort is just for cancer research. As you might have guessed, I eventually learned that a good many of

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those stories were true.

In 2001 everything changed at Fort Detrick. That year’s anthrax attacks were followed in short order by a fundamental policy shift from biomedical to biodefense research and funding.

By 2003 biodefense had become big business, and high-containment biosafety level 3 and 4 labs performing research with biowarfare pathogens were proliferating around the country.

The militarization of basic biomedical research was underway. Fort Detrick was named national headquarters, home to the National Interagency Biodefense Campus (NIBC) that would house high containment labs for the Army, Homeland Security, National Institutes of Health, Department of Agriculture and others. We’re not certain of the ultimate size of the NIBC, as that information is not publicly available. Estimates have changed over time, as have the mission statements and lists of pathogens that will be investigated, but Congressional testimony in 2007 indicates that the 8,600 Square feet of BSL-4 labs operating at

that time at Fort Detrick will grow to over 1.3 million square feet of level 3 and 4 labs by the time the NIBC is complete. It will be the largest biodefense lab complex in the world, researching pathogens such as Ebola, plague, tularemia, anthrax and numerous other pathogens.

In the meantime Frederick is no longer a small country town. It has grown to over 60,000 people and 235,000 in the county. Fort Detrick sits on 400 acres located near the city’s historic core, and the Fort is now surrounded by thousands of homes and many schools. Half of the acreage is now a superfund site, not yet fully remediated from TCE/PCE contamination mixed with pathogen infected animals carcasses and vials. Funding limitations have made for slow cleanup over the past 21 years.

The community first learned of the planned lab expansion in 2003, with the first of three nearly identical Environmental Impact Statements (EIS) that were issued over three years, one for each of the three largest NIBC

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lab complexes. These documents were veritable cut and paste duplicates that provided little in the way of credible risk assessment. Over the past seven years the community has engaged in a long and frustrating journey through what we have concluded is a broken National Environmental Protection Act process. We have organized and fought hard for community rights here in Frederick. We also know that high containment biodefense lab proliferation is a national policy problem that has to be addressed in Washington.

Locally, we have been working to get that credible risk assessment, because we agree with NEPA that it is needed for adequate risk mitigation and also because the public needs to know clearly and explicitly what risks we are being asked to assume. It is also the law—a law designed to protect communities. We are also working to try to ensure comprehensive public health preparedness, transparency, public accountability and a way to make sure that community concerns are actually addressed. We work with other biodefense lab communities around the country and lobby for policy changes.

We have learned a great deal about NEPA, hazard assessments, biodefense labs, and the research being conducted with bioweapons pathogens. This learning curve is a significant barrier for the general public to feel they can understand the NEPA documents, comment and get involved, but I’m impressed with how much people can contribute when equipped with a healthy dose of common sense. We have discovered that our specific health and safety concerns are also of concern to credible scientists, members of Congress and the Government Accountability Office.

The risks? Public health risks from accidents and insider sabotage are high on the list. The most disturbing scenarios—and the ones not assessed in the EISs—are what happen most often: workers do not realize they are infected and go home. This happened at USAMRIID last November with a worker who almost died from a tularemia infection before being properly diagnosed and treated. An Army investigation revealed that this worker failed to follow multiple “ironclad” procedures, and as a result visited several

local doctors, flew to another city for Thanksgiving, and walked around the community for several weeks before it became clear that she was ill from something other than the flu. Insider threat has already happened of course, with the Anthrax attacks, though it was deemed improbable and therefore was not evaluated as a potential risk in the EISs. So, what has happened with our seven years of community organizing?

We attended scores of formal NEPA meetings, provided hundreds of pages of detailed comments, and worked closely with local and national elected officials, the press and other local players. In 2007 a host of people—scientists, engineers, lawyers, business people, just people—spent hours testifying before our local Board of County Commissioners, asking them to sponsor a court review of the EIS. In early 2008 we drafted a detailed petition to the Army, to the County Commissioners and to Senator Barbara Mikulski, DMd., asking for a National Academy of Sciences safety study. This approach gained political support. After 18 months of painful negotiation with the DOD, the study was conducted in the fall of 2009, the results released in March 2010.

The NAS committee concluded that the Environmental Impact Statement hazard assessment was not credible. It concluded that community trust was lacking and NIBC communication with the surrounding community was poor.

The committee supported the community’s assertion that there were real gaps in public health preparedness and planning. The committee made some excellent recommendations for improvements—and it stated that

because there would be state of the art equipment and procedures, the committee was confident that the labs would be safe. While the committee found the failed risk assessment to be unfortunate, they did not recommend it be revisited. They recommended that federal entities endeavor to do better in the future. Senator Mikulski has demanded that all of the NAS recommendations be implemented. Two months later, nothing has occurred.

There will be no new risk assessment.

What’s wrong with this picture for all of us? Well it certainly makes clear just how broken the NEPA process is.

Agencies hire contractors to evaluate projects, resulting in EISs that are not independent assessments and do not serve to protect communities, as intended by law. It is a profitable repeat business, understood to be a paper chase. A successful lawsuit may require a more useful and adequate EIS that actually informs decisionmaking about location and other factors, as it is supposed to. Unfortunately we were unable to raise the significant funds necessary to take that action— and short of a lawsuit, there is little citizen recourse for failed EISs. There needs to be a legislative fix for this conflict of interest, a rule change with the EPA to ensure that those conducting the EISs do not have a financial interest in the success of the agency requesting them.

It was also clear from the testimony of lab officials during the National Academy study process that officials at the Fort were so confident that a pathogen would never escape the labs that there were significant gaps in planning for what would happen if one did. This was particularly evident for continued on page 23

VOLUME 23 NUMBER 2

GENEWATCH 15

Teatime in the Lab The twelve-year ordeal of David Bell and Sandi Trend

BY SAM ANDERSON

Photo: Jeff Karpala

The cautionary tale of David Bell begins when he was a college student in 1998, a biology major and aspiring biotech researcher at California State University, Sacramento. In his final year of college, he was hired to work for AgraQuest, a venture biotechnology company in Davis. His stay at the company would not be long, but its impact would be long-lasting. Over a decade later, he and his mother, Sandi Trend, are still looking for justice.

David had worked at AgraQuest just over five months when he fell ill.

Earlier that week he had been asked to clean a barrel used for a previous fermentation experiment, containing a gallon of leftover materials.

Although he was assured at the time that the barrel would be safe to work with, the researcher who helped him wore a HEPA mask. The barrel’s contents were dumped into a storm drain next to the building and David cleaned it with household bleach.

Early the next week David had to

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leave work with serious sinus problems, and shortly afterward was admitted to an emergency care clinic.

He would later discover that the rest of the office became ill too, and that within the week AgraQuest sent its employees home and locked its doors.

David would not discover this until later—much later, because he was unable to return to work for five weeks. But David’s sinus problems lingered, his immune system was seriously weakened, and he continued to show some rather graphic symptoms involving, as David bluntly puts it, “the crap coming out of my face.”

After four sinus surgeries, David’s health is still in question —and AgraQuest has yet to accept any responsibility. In court, its lawyers openly questioned whether David had even received those surgeries, and if he had, whether they were really necessary. It would seem David has earned the right to be blunt. ***

From where Sandi and David sit, the deck was stacked against them from the start. When David first visited the hospital with mysterious symptoms, he asked the doctor to run a culture in order to discover what might be infecting him; later, the doctor said she had forgotten to run the culture. It happens that AgraQuest founder Pam Marrone sat on the board of that hospital, and that David’s doctor would have known Marrone from sitting on the same community women’s council.

When they eventually went to court in an attempt to get workers’ compensation, the judge assigned to David’s case had previously worked for a firm that represented Liberty Mutual – the defendant. David’s own attorney had trained under the opposing lawyer, and she asked David to dismiss her.

David says that his eventual lawyer, John Overton, was so dismayed by what he called a “kangaroo court” that he considered leaving the legal

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profession.

All of this may very well have been coincidence. The more compelling— and more serious—accusations of misconduct are reserved for David’s employer, AgraQuest.

AgraQuest was founded in 1995 by Pam Marrone, a former Monsanto pesticide researcher. Marrone aimed to discover and commercialize biopesticides as alternatives to chemical pesticides. The company’s approach, in the words of Marrone: “We move very fast. We focus on getting things to the market quickly.” AgraQuest still exists today—sans Marrone—and appears to have shifted much of its focus toward agrichemicals. The company’s website touts a corporate culture which encourages employees to “maintain an environmentally conscious work environment.” It may be true today, but in 1998, when David Bell began work at AgraQuest as a college senior, this was not exactly the case.

Marrone set up shop in an office suite in a residential neighborhood of Davis, California. Whether the businesses renting the adjacent offices knew at the time that their neighbor had converted Suite 4 into a lab is unclear, but David says that at one point other offices did complain about the smell from a project he had been assigned. David was assigned to conduct experiments using an evaporator set up in a room with only an open window for ventilation. After neighbors complained about the smell, the device was moved into a bathroom, which featured an upgraded ventilation system: the bathroom fan. Neither David nor anyone else, save one coworker, wore protective masks.

If these do not sound like descriptions of a high security biolab, that’s because this wasn’t one. The Center for Disease Control “recommends” a Biosafety Level 3 setup for the type of work AgraQuest was doing, but does not require it. David supposes the office suite was “technically” a Level 2 lab; however, CDC guidelines on Level 2 labs call for the use of biological safety cabinets to contain potential airborne contaminants, and a bathroom with a fan hardly qualifies.

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Much of the work happening in the AgraQuest lab involved a sort of biological treasure hunt. Researchers brought in soil samples from around the world, then combed through them, searching for natural pesticides.

David recalls AgraQuest coworkers pulling bags of soil out of a briefcase, boasting about getting the samples through airport security.

The hunt for exotic pest-killing organisms went on amid safety precautions David compares to those of a high school chemistry lab. The company did not provide its workers with a safety manual, although it created a short manual in time for David’s workers compensation trial. In addition to the lax use of protective masks and the potentially hazardous experiments conducted without the benefit of a safety hood, employees were allowed to wear their lab clothes home without cleaning them first. The waste disposal system was no better, as AgraQuest workers often dumped leftover materials into a storm drain outside the building. After David ‘s illness, Sandi went to 1105 Kennedy Place and took pictures of the drain.

She found, ominously, a dead crow crumpled beneath a faucet covered with chemical deposits. Even more ominously, when she returned two weeks later with mold expert Doug Haney, the bird was still there—and showed no signs of decomposition.

Haney was surprised: “After two weeks I would have expected to see almost bones and a little bit of feather.”

Many of AgraQuest’s slipshod safety controls might have been corrected had there been any federal regulatory oversight; but David and Sandi say the CDC failed to investigate David’s claims, and OSHA waited months before making a visit to the company, citing them only for a few faulty hoods. In fact, the one agency which followed up David and Sandi’s reports was the Department of Agriculture’s Animal and Plant Health Inspection Service, which did not take the matter of soil smuggling lightly.

In the absence of inspections, the culture in AgraQuest’s Davis lab was nonchalant about safety. Almost any place within the office suite was

inbounds for lab work, from the bathroom to the break room. Employees ate and experimented in the same space, washing dishes and lab equipment in the same sinks. David was particularly surprised to discover a workplace tradition at the lab: each afternoon the researchers would gather, there in the workspace amongst tropical soil cultures and anti-malaria experiments, and have teatime. *** Sandi and David filed complaints with over a dozen agencies, from the Yolo County Health Department to the Attorney General of California to the National Institute for Occupational Safety and Health. First they reported the lab conditions and the company’s treatment of David; then they reported the lack of investigation into these issues. To this day David has not received compensation for his illness; AgraQuest has not admitted fault in David’s condition and has not been formally reprimanded; and Sandi and David still do not know exactly what made David sick.

“God only knows what he was exposed to,” Sandi says. “Doctors don’t even know what to look for.”

David’s research career is long over and his immune system has yet to recover, but he has started looking for jobs in a new field. Yet all this time, even after all legal avenues for compensation seem to have closed, Sandi has lost none of her drive to expose what happened to David and warn other workers of what they are up against. “We can sit around and get mad all we want,” she says, “but somebody’s got to change this.”

David remembers a professor telling his class not to be concerned about the safety hazards of lab work.

“My old professor assured me: ‘Don’t worry. Your scientist brethren are going to take care of you, because it could be them instead of you.’

That’s not what happened in my case. Not at all.”

Sam Anderson is Editor of GeneWatch.

GENEWATCH 17

Book Review Breeding Bio Insecurity and Germs Gone Wild

BY ANDREW D. THIBEDEAU

Breeding Bio Insecurity1 by Lynn C. Klotz and Edward J. Sylvester and Germs Gone Wild2 by Kenneth King cover substantially identical material and make substantially identical arguments: there is a gross overestimation of the threat of foreign bioterrorism, and the resulting proliferation of domestic research facilities housing the world’s deadliest pathogens represents a far graver risk than the one it seeks to combat.

Existential threats from dangerous biological agents are nothing new, however. While laying siege to the Italian trading outpost at Caffa in 1347, the Mongol attackers “began to die in large numbers from an unknown but incredibly virulent disease.” Forced to retreat, the story goes that “before the Mongols departed, they catapulted the bodies of victims into the city.” Sickened by the disease, the Italian traders returned to Europe, introducing the bubonic plague to that continent.3 During the 16th Century, Spanish conquistador Francisco Pizarro “purposely tried to spread smallpox among the native Incas by distributing blankets used by people with the skin lesions of the disease.” Centuries later, during the French and Indian War, “[t]he same strategy was used in an attempt to spread smallpox among Native Americans.” Both the British and the American colonists “purposely gave gifts of contagion-laden blankets to Indians allied with the French.”4 “Biodefense” is the State’s response to these kinds of biological threats, and is generally defined as “the development of medical countermeasures and diagnostics for infectious agents and biological toxins that have been identified as potential threats on the battlefield.”5 What’s more, biodefense is not cheap. There are reasons that national biodefense budgets usually run in the billions: turning even naturally dangerous pathogens into effective biological weapons—“weaponizing” them—is an

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extremely difficult business. “Offensive, including terrorist, use of biological agents presents major technical problems . . . [t]hat is why the Soviet Union, United States, United Kingdom and others needed to spend vast sums for decades in order to research and develop biological weapons.”6 Both Breeding Bio Insecurity and Germs Gone Wild observe that the biodefense industry— and correspondingly the public imagination—nevertheless focus on a few, particularly deadly pathogens as potential bioterror agents, namely: anthrax, smallpox, plague, ricin, botulinum, tularemia, and hemorrhagic fever viruses like Ebola, Marburg, and Lassa.

Despite their deadly reputations, however, none of these disease agents make for very effective bioterrorist weapons.

Anthrax infection can be cured with aggressive antibiotics, even after symptoms have manifested. Moreover, Anthrax is very difficult to manufacture in large quantities and aerosolize, both necessary for it to be used as a bioweapon. Although extremely dangerous, in developed countries a smallpox outbreak could be averted with a sufficient stockpile of vaccine, given the warning of early cases. Smallpox is also a particularly unlikely choice of bioweapon for Islamic terrorists. The Islamic world is substantially more vulnerable to the disease because of its young (and thus unvaccinated) population, crowded living conditions, absence or extreme scarcity of vaccine, and inadequate healthcare facilities. In the case of plague, the images of horror conjured by its name notwithstanding, even in its most deadly form—pneumonic infection with the bacterium Y. pestis—it can be cured with common antibiotics. Conjointly, Y. pestis is a highly fragile organism and is thus extremely difficult to weaponize.

Both ricin and botulinum are proteins, which mean they are large molecules that are difficult to stabilize—a necessity in order to weaponize them.

Breeding Bio Insecurity Lynn C. Klotz and Edward J. Sylvester University of Chicago Press, 2010.

MARCH-APRIL 2010

Tularemia—otherwise known as rabbit fever—is a poor choice as a bioweapon because of its low mortality rate (about one in a hundred) and the fact that it is not contagious. Finally, in spite of their gruesome symptoms, hemorrhagic fever viruses like Ebola, Marburg, and Lassa are not very contagious. Even in Africa these diseases are not a serious public health concern; outbreaks are small, claiming perhaps two dozen victims at most. What’s more, it is unclear whether it is possible to weaponize them at all. Even assuming that this were possible, the level of technology required would limit their development to only the most advanced nation states.

As Klotz, Sylvester, and King point out, these considerations do not eliminate the risk that these pathogens might be used in a bioterror attack against the U.S. However, they do call into question the likelihood and impact of such an attack. “Neither we nor anyone else can say [bioterror attacks] are impossible,” Klotz and Sylvester remark. But for the reasons outlined above, they do argue that “massive assault capabilities from small numbers of nonstate players . . . are quite implausible.”7 Moreover, Klotz and Sylvester remind us, “[w]e must also balance our biosecurity spending and actions between the ever-present threats to public health—AIDS, tuberculosis, malaria, antibiotic-resistant infections, [and] emerging flu strains.”8 As a result of the anthrax letters of 2001, the only actual bioterror attack against the U.S.—now known to have been perpetrated by a scientist working for the U.S. government—five people died. In comparison, in the U.S. in 2006, 56,326 people died of influenza and pneumonia, 34,234 died of septicemia, 12,644 died of HIV-related infection, 7,250 died of hepatitis, 5,897 died of “unspecified” infectious and parasitic diseases, and 2,556 of malnutrition.9 This begs the question why the U.S. government—not including the military—spent nearly $55 billion dollars between 2001 and 2010 researching anthrax, smallpox, plague, ricin, botulinum, tularemia, and hemorrhagic fever viruses.10 Klotz and Sylvester argue that rather than focusing on public policy “that build[s] protection against genuine public health threats,” the U.S. has instead favored policies “that use fear and alarmist tactics to

VOLUME 23 NUMBER 2

lead away from biosecurity while claiming to protect.”11 Backed by $55 billion, U.S. government policy has caused a “massive expansion of high-biosecurity labs and has encouraged universities and private sources to build them.”12 Both Breeding Bio Insecurity and Germs Gone Wild make the ultimate argument that this outcome has made the U.S. less safe. “Our bloated, largely secret biodefense program increases the risk of accidents and theft by terrorists,” Klotz and Sylvester warn, “and its lack of transparency may be inadvertently fueling an international arms race in bioweapons.”13 While Breeding Bio Insecurity and Germs Gone Wild cover the same ground, they are markedly different in tone and likely aimed at different audiences. Klotz and Sylvester provide a compact but easily-accessible account of the dangerous course traversed by the U.S. biodefense industry in the last decade. Their tone is that of the courtroom advocate, presenting arguments that, though forceful, are clear and wellreasoned. King takes the tone of the activist in the street, writing with a passion and emotive voice that Klotz and Sylvester lack.

King discusses his personal involvement with efforts against the construction of a biological research laboratory near his home, and throughout his book conveys a proximity to the issues that lends his account a frenetic authenticity. While some might find this appealing, it is ultimately the source of the book’s critical flaw: a failure to recognize nuance and complexity, compounded by a disorderly presentation. King describes a black-and-white ethical universe in which the “academic-militaryindustrial complex” is aligned diametrically against the interests of the U.S. citizen.

King’s outlook, likely attributable to his proximity to “the struggle,” rejects the possibility that some biodefense research is justified or even useful.

This is contrary to fact. Despite the dangers associated with biodefense research, Klotz and Sylvester never suggest “a simplistic set of regulations that would achieve some form of biosecurity at the expense of the enormous potential already demonstrated by the new biology.”14 They point to recent work done with botulin, the most potent poison known, which increased its killing power fourteenfold.15 Alongside botulinum’s potential as a bioweapon,

Germs Gone Wild Kenneth King Pegasus Books, 2010.

however, it has countless clinical uses, from stroke, to cerebral palsy, multiple sclerosis, back spasms, and tennis elbow.16 The ability to increase the toxin’s potency has also increased its usefulness in treating these and other ailments. All biodefense research, therefore, is not alike.

While King’s overly-simplistic stance toward the utility of biodefense research detracts from the logical coherence of his argument, he is largely correct that the lion’s share of that research—if not completely without utility—is at a minimum an unjustifiable draw on limited resources. Here King, Klotz, and Sylvester agree: most of the funds directed to biodefense research ought instead to be spent on more common public health threats, like HIV and common influenza. The authors rightly conclude that U.S. research policy should focus on public health rather than on public fear.

Andrew Thibedeau is a Fellow of the Council for Responsible Genetics.

GENEWATCH 19

Topic Updates: Genetic Discrimination

BY JEREMY GRUBER

First Public Case of Discrimination under GINA In what appears to be the first publicly identified case of its kind, a Connecticut woman has accused her employer of violating the recently enacted federal Genetic Information Nondiscrimination Act (GINA).

With a family history of breast cancer, 39-year-old Pamela Fink and her two sisters took genetic tests at the Yale Cancer Center. The tests showed that all three carried the BRCA2 gene, predisposing them to breast cancer.

Both sisters developed breast cancer, but survived with treatment. After several biopsies and frightening false alarms, Fink opted for a preventative double mastectomy last year.

Feeling comfortable in what she described as a supportive work environment, she told her bosses at MXenergy about her genetic tests and the surgery, she said.

Fink alleges that, despite giving her “glowing evaluations for years,” her employer, MXenergy, soon thereafter “targeted, demoted and eventually dismissed her when she told them of the genetic test results.” MXenergy denies any wrongdoing.

GINA, which was passed by Congress in 2008 and took full effect late last year, represents the most comprehensive effort to date to regulate the use of genetic information by employers (Title II) and health care insurers (Title I) in the United States. Under Section 201(a)(i) of GINA, employers with more than 15 employees may not “discriminate against any employee with respect to the compensation, terms, conditions, or privileges of employment…because of genetic information.”

As with other civil rights laws, Title II requires that a complaint first be filed with the Equal Employment Opportunity Commission. Peggy R. Mastroianni, the

20 GENEWATCH

commission’s associate legal counsel, said most of the 80 complaints filed since the genetic law took effect seemed to involve cases in which employers had improperly acquired or disclosed genetic information. But Ms. Fink’s case alleges a more serious offense: an improper firing because of it.

How and if this case proceeds may shed light on how the EEOC and possibly the judiciary will begin to apply GINA. Regardless, it is an important reminder to employers and health insurers that GINA is now the law of the land.

Canada Considers Genetic Discrimination Law Canadians need better protection from genetic discrimination by insurers and employers, according to Winnipeg North MP Judy WasylyciaLeis. Mrs Wasylycia-Leis recently introduced Bill C-508, “An Act to amend the Canadian Human Rights Act,” in the Canadian House of Commons to prohibit discrimination on the grounds of a person’s “genetic characteristics.”

As other nations have begun to enact

such protections, supporters of the new bill claim Canada has fallen behind.

Currently, Canada does have several laws protecting individuals from discrimination on the basis of disability.

However, none of this legislation addresses the concepts of future disability, perceived disability or imputed disability. Nor does it prevent discrimination from taking place; rather, it offers remedies after discrimination has occurred. This puts the onus on the victim of discrimination to make the complaint and then seek appropriate legal action - a lengthy and expensive process.

Over the past two decades, various commissions and task forces have called for reform in Canada but none of their recommendations have been implemented. Meanwhile, the Canadian insurance industry’s position continues to be that if an individual has undergone genetic testing, insurers can request access to the results. Because Canada has a universal health care system, access to life, disability and critical care insurance - rather than health insurance - are the biggest issues at stake.

“This bill will stop Canadians’ personal genetic information from being used against them,” said Wasylycia-Leis in a press release preceding introduction. “Employers, insurance companies and others have already begun to discriminate against people based on their genetic make-up. People are being punished in fundamental ways—like being prevented from earning a living or buying a house—for something they have no control over. That’s unfair and this bill will update the Canadian Human Rights Act to deal with this 21st century problem.”

The Canadian Coalition for Genetic Fairness (CCGF) which was modeled after the Coalition for Genetic Fairness in the United States which led the successful effort to enact GINA, helped Mrs

MARCH-APRIL 2010

Topic Update: DNA Databanks The Texas Department of State Health Services sent 800 infant blood samples to the Army’s forensic mtDNA database project - without parental consent Wasylycia-Leis draft the bill. The CCGF wants regulatory reform for the insurance industry in light of genetic advances with particular attention on life, critical care, disability, and mortgage insurance.

Mr. Don Lamont, CEO of the Huntington Society of Canada and chair of the CCGF, says predictive testing is “a good thing,” but warned it also carries “a growing fear that the information can lead to stigma and discrimination.”

For more information on the Canadian Coalition for Genetic Fairness (CCGF) and how to support their efforts, you can visit their website at: www.ccgf-cceg.ca/en.

Jeremy Gruber, J.D., is President and Executive Director of the Council for Responsible Genetics.

VOLUME 23 NUMBER 2

The state of Texas has for years collected drops of blood from newborns in order to screen for birth defects. The baby’s heel is pricked and five drops of blood are collected on a card, which is thrown out shortly after the screening.

Except when it isn’t.

Without ever notifying parents, the Texas Department of State Health Services changed its policy in 2002.

First it simply stopped discarding the blood samples after screening for birth defects. Then, with 800,000 samples coming in each year, the state began warehousing the cards at Texas A&M University. The DNA samples were ostensibly to be used for research purposes, but as The Texas Tribune reported earlier this year, 800 de-identified samples were also sent to be included in the creation of a national mtDNA foren-

sics database, a $1.9 million project initiated by the Armed Forces DNA Identification Laboratory (AFDIL).

In research proposals dug up by the Tribune, the intention emerged to build an international mtDNA database to advance anti-terrorism investigations.

While a large forensic DNA database already exists in the U.S., mtDNA is especially valuable, as it is easier to find and extract than nuclear DNA. AFDIL indicated that it was seeking anonymous mtDNA samples in order to increase the sample size of its budding database.

Scientists insist that mtDNA samples can be fully de-identified so that the sample can never be traced back to the individual who gave it; yet all parties involved in using the newborn samples for the AFDIL database—DSHS, AFDIL, and Texas A&M—neglected to make public note of the project, and in fact made specific efforts to keep it under the radar. DSHS emails revealed state officials’ concerns that only bad publicity could come of press about the project, and the agency convinced Texas A&M to pull a press release announcing their partnership.

Researchers also made it clear that their work would go more smoothly if the DNA collection were kept under wraps. As the Tribune notes: “The problem … is that scientists have used the public’s unease with the subject as an excuse not to talk about it.”

GENEWATCH 21

Flushing It Down the Rabbit Hole Study finds biodefense policy ineffective and biosecurity scientists confused

BY ANDREW D. THIBEDEAU

In response to the 2001 terrorist attacks, Congress passed the USA PATRIOT Act of 2001 “[t]o deter and punish terrorist acts in the United States and around the world [and] to enhance law enforcement investigatory tools.”1 Shortly thereafter, Congress enacted the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 “[t]o improve the ability of the United States to prevent, prepare for, and respond to bioterrorism.”2 In the current issue of the Proceedings of the National Academy of Sciences, M. Beatrice Dias of Carnegie Mellon University and colleagues report the findings of a study conducted to gauge the impact of these laws on bioterrorism research.3 The study focuses on research trends in so-called “select agents” research. Select agents are pathogens and toxins listed by the US government that pose a severe threat to public health and safety. They include smallpox, anthrax, botulin toxin, the 1918 flu virus, Ebola, Ricin, and plague.4 Looking for patterns in anthrax and Ebola research publications, the study reveals many shocking findings. “The most striking observation,” Dias et al. observe, “is a significant increase in the role of the military laboratories in ‘livepathogen’ select agent research and the relative decline in the centrality of the civilian government laboratories.”5 Nevertheless, at the same time, “research became less efficient.”6 Prior to 2002, for every $1 million of research funding, seventeen papers on anthrax were produced. After the passage of the USA Patriot Act and the Bioterrorism Preparedness Act, the average fell to three per $1 million. The study finds as much as a fivefold loss in research efficiency.7 The authors reveal other disquieting trends in the biodefense field. Contrary to lawmakers’ intent, research “[n]etwork centralization decreased over the study period for ‘live-pathogen’ research” on both 22 GENEWATCH

Photo: Grace Twesigye

Ebola and anthrax. In other words, the number of researchers and research institutions working on these lethal pathogens grew significantly. This has translated to a proliferation of new biodefense laboratories across the nation. At the same time, senior scientists have begun leaving the field in significant numbers. Though researchers interviewed for the study remarked that “the increased US funding led to an influx of new scientists,” many did not stay for long. What’s more, given the inherently international nature of the biosecurity threat, it is troubling that the study also observes “a pattern of decline” in international collaboration on biosecurity research. Taken together, the proliferation of new biohazard facilities, the influx of new, less-experienced personnel, and the decline in international cooperation begs the question: are we safer?

Finally, and most problematic, the scientists that were interviewed repeatedly pointed to the supposed MARCH-APRIL 2010

administrative burden that government regulation placed on their research as the primary cause animating these trends. “Nearly all authors complained of the increased paperwork that they were legally obligated to fill out,” the study reports, “one of them estimating that it took twice as long to do any project as a direct result of the bureaucratic overhead.” When questioned, another researcher lamented that “the FBI background checks took so long that they interfered with hiring students and technicians, especially non-US citizens.” Rules restricting laboratory access and the transport of deadly organisms are cited as making “the process of collaborating . . . significantly slower and more tedious.” In 1998, it took about a month to obtain clearance to work in a BSL-4 facility.

Now, owing to “all the background checks and psychological and medical testing . . .[i]t easily takes close to 6-9 months.”8 This view is strikingly at odds with those held outside the biodefense establishment. As Beth Willis writes in her article The Lab in My Backyard: “[l]abs certainly need better regulation and oversight to ensure adequate safety.” In A Cruel and Unusual

Corporation, Ralph Nader expresses outrage that OSHA “has been without any regulations or disclosure requirements about biohazards in laboratories.”

Perhaps David Bell’s shocking ailment would have been averted, Sam Anderson speculates in Teatime in the Lab, “had there been any federal regulatory oversight” or if OSHA had made a timely visit to AgraQuest’s “slipshod” laboratory.

In the last analysis, the study’s findings point to one inescapable conclusion: neither the USA PATRIOT Act nor the Bioterrorism Preparedness Act has improved our ability to prevent, prepare for, and respond to bioterrorism. Instead, they have helped to create an over-funded and under-regulated biodefense community that appears utterly oblivious to the grave risk it poses to the public health. It is thus somehow fitting that the special agents list also includes tularemia, or rabbit fever—for it is only down a rabbit hole in the Alice-in-Wonderland world of U.S. biodefense that billions of dollars and regulatory absenteeism could breed such a deadly combination of lethal pathogens and willful incompetence.

continued from page 15

scenarios not assessed in the EIS, such as for certain insect vectors and the real possibility of lab workers not knowing they are infected. Key emergency-related questions did not have clear answers. Five federal departments, three major lab complexes— who do local officials call to get answers? Who has knowledge and authority for all of NIBC? If there is an accident, who will lab officials contact in the community and under what circumstances? How will lab officials work with the county public health officer? Who has authority to determine when quarantine is required?

Who do local doctors and ER staff contact at the labs if they think they are dealing with laboratory acquired infection? How would these local doctors even know, particularly in the case of a novel pathogen? These are all questions we hope will now start to be addressed. They are not theoretical questions—most of the above incidents have already occurred. These questions are relevant to all communities

VOLUME 23 NUMBER 2

in proximity to biodefense labs.

And yes, we continue to grapple with the massive inequity of power between powerful, mission-driven bureaucracies and local communities.

Communication is inherently difficult between two these very different worlds. Lab officials are clear that they believe additional information about lab safety will address citizen “fearfulness.” The community sees this characterization as dismissive of the specific issues we have raised and avoids the establishment of a real role for elected officials and citizens in addressing public health and safety.

The input of citizens, public health and elected officials needs to directly inform all aspects of laboratory planning, design, development and operations. Labs should have informed siting; whereas in the case of Fort Detrick, no alternative locations were ever considered.

Leadership at Fort Detrick changes every 3 or 4 years, as do our elected officials. We are a long way from find-

ing an effective means to ensure that community rights are both established and do not fade away with each changing of the guard. Establishing a requirement for an independent community board with teeth is a nationwide necessity for siting large federal and military projects and should be addressed in federal law.

The simplest solution is to use these labs for research of more direct concern, focusing on emerging public health issues rather than theoretical bioterror threats. Labs certainly need better regulation and oversight to ensure adequate safety. We are told that at Fort Detrick we have the best procedures available … except when they don’t work. It’s cold comfort.

Beth Willis is a leader of the Frederick Citizens for Bio-lab Safety.

GENEWATCH 23

continued from page 9

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

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

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.

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

24 GENEWATCH

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

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.

MARCH-APRIL 2010

Commenary: GM Crops

NRC Report on Genetically Engineered Crops Falls Short on Sustainability

BY ERIC HOFFMAN

On April 13, 2010 The National Research Council (NRC) of the National Academies of Sciences recently released their report, “The Impact of Genetically Engineered Crops on Farm Sustainability in the United States” in Washington, DC. This report set out to document the environmental, economic, and social effect of genetically engineered (GE) crops on farms and farmers throughout the country. While the report should be applauded for its attention to the serious threat farmers face from the emergence of Roundup-resistant weeds, it ignores the true culprit of this problem —GE—and instead promotes further use of technology to solve problems created by the technology itself.

The NRC report notes that since the introduction of Roundup-Ready crops —which can survive the spraying of glyphosate, marketed by Monsanto as Roundup—nine weed species in the U.S. have evolved resistance to glyphosate. This has caused farmers to complement their glyphosate usage with more toxic herbicides and use tilling methods that lead to increased runoff and soil degradation. The NRC’s report warns that continued use of glyphosate will eventually render it ineffective. Two types of pests have also built a resistance to another GE trait, Bt-toxin, a pesticide that is grown inside the cells of some GE plants.

The proposed solution is to develop new GE herbicide resistant crops, putting us in a futile fight to outsmart nature. Weeds and bugs will continue to evolve resistance to chemicals regardless of how many billions of dollars are spent on genetic engineering, just as we see with antibiotic resistance in medicine.1 Genetic engineering will never out-engineer evolution.

VOLUME 23 NUMBER 2

The NRC believes that genetic drift from GE crops to non-GE crops is not a serious concern. This could not be further from the truth. Unlike traditional pollution that dissipates over time, genetic contamination—the flow of undesirable genes from one plant to

another—is permanent and can spread endlessly throughout a species. The effect of GE on humans and the environment has yet to be well documented or tested, and current safeguards to prevent contamination are inadequate.

Permitting the potential for such irreversible contamination to occur when so many unknowns remain and so little oversight is in place is irresponsible public policy that endangers public health, our agricultural economy, and the environment.

The most outlandish claim from the NRC is that GE crops help organic farmers by creating a market for nonGE foods, for which they can receive a premium price. This is like saying that the Manhattan Project created a market for personal fallout bunkers.

Genetic drift from GE crops is a direct threat to GE-free crops such as organics and has led to numerous farmers losing access to this “niche” market. A GENEWATCH 25

recent report documented 39 cases of genetic contamination of organic and conventional non-GE seeds in 2007 and more than 200 in the last decade.2 Recent controversies involving Monsanto’s GE alfalfa and other GE crops shows that the environmental and economic damage caused by GE seeds is real, causing farmers to lose their very livelihood due to genetic contamination.3 The NRC believes that the federal government should fund private and public institutions to develop “public good” traits that could increase yields, increase nutritional value, and survive droughts. Yet we already have seen small-scale, sustainable and agro-ecological approaches to agriculture that do all of these things. Sustainable agriculture can meet the world’s growing demands for food and has proven to increase yields,4 increase nutritional value,5 mitigate the dangers posed by climate change,6 and can increase soil and water quality.7 Why waste billions of taxpayer dollars on technology that a few corporations will own and have yet to deliver any real benefits to society?

The International Assessment of Agricultural Knowledge, Science, and Technology for Development (IAASTD),8 which was written by more than 400

scientists and signed by nearly 60 governments around the world, says that industrial agriculture has degraded our natural resources and threatens the world’s food, water, and energy security. The report, sponsored by the United Nations, the World Health Organization, and the World Bank, continues by stating that industrial agriculture’s “business as usual [approach] is not an option.” GE crops will not reduce hunger and poverty, and will only exacerbate social inequality and environmental degradation. IAASTD concludes that sustainable agriculture—where farmers have access to and control of their resources and local markets—is the right solution. A 2007 study from the University of Michigan concluded that organic agriculture could actually increase global food production by as much as 50 percent without using more land.9 Genetic engineering, on the other hand, has already failed to increase yields.10 What has increased due to the planting of GE seeds is the amount of pesticides being sprayed—over 300 million more pounds during the last 13 years.11 Sustainable agro-ecological farming methods are being used throughout the world and are threatened by the spread of GE crops—often forcibly through U.S. trade and food

aid policies.

The NRC’s continued reliance on more GE for the very problems GE causes is troubling. Instead of promoting research into a technology that forces farmers to buy expensive chemical inputs, threatens the livelihoods of non-GE food producers around the world, and provides no real-world benefit to those who eat the food, we should promote the sustainable agro-ecological practices that have been tested for over ten thousand years. Sustainable agriculture has been shown to increase yields, increase nutritional value, and can mitigate the dangers posed by the climate crisis while increasing soil and water quality. We must shift our research money and efforts away from unreliable and dangerous genetic engineering technology and towards sustainable food production. It is not often we are lucky enough to have a low-tech, low-cost solution that can feed the world and regenerate our environment sitting right in front of us. It is time the U.S. broke away from this failed technology and started supporting real-world solutions that have proven benefits and global support.

Eric Hoffman is the Genetic Technology Policy Campaigner for Friends of the Earth.

25 Years of GeneWatch GeneWatch Anniversary Archive: 1983-2008 The Council for Responsible Genetics was founded in 1983 to provide commentary and public interest perspectives on social and ecological developments of biotechnology and medical genetics. For a quarter of a century, the Council has continued to publish its magazine GeneWatch with articles by leading scientists, activists, science writers, and public health advocates. The collection of GeneWatch articles provides a unique historical lens into the modern history, contested science, ethics and politics of genetic technologies. The full archive of GeneWatch has been incorporated into this special anniversary DVD that includes an index of all the authors and titles.

Copies of the anniversary DVD are available for a $100 donation to: Anniversary CRG DVD Council for Responsible Genetics 5 Upland Rd., Suite 3 Cambridge, MA 02140

26 GENEWATCH

MARCH-APRIL 2010

Endnotes

“One Bug, One Drug,” L. Klotz and E. Sylvester, p. 12

“Commentary: GM Crops,” Eric Hoffman, p. 25

1. www.stopthebiolab.org 2.http://www.niaid.nih.gov/topics/BiodefenseRelated/Biodefense /Documents/biosp2007.pdf

1. Putting Meat on the Table: Industrial Farm Animal Production in America. Rep. The Pew Commission on Industrial Farm Animal Production, 2008. Web. <http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Re ports/Industrial_Agriculture/PCIFAP_FINAL.pdf>.

2. GM Contamination Register Report 2007. Rep. Greenpeace International. <http://www.greenpeace.org/international/Global/international/planet-2/report/2008/2/gm-contamination-register-2007.pdf>.

3. K.L. Hewett, The Economic Impacts of GM Contamination Incidents on the Organic Sector, 16th IFOAM Organic World Congress, Modena, Italy, June 16-20, 2008.

4. Badgley, Catherine, and Ivette Perfecto. “Organic Agriculture and the Global Food Supply.” Renewable Agriculture and Food Systems 22.2 (2007): 86-108.

5. Benbrook, Charles, Xin Zhao, Jaime Yáñez, Neal Davies, and Preston Andrews. New Evidence Confirms the Nutritional Superiority of Plant-Based Organic Foods. Rep. The Organic Center. Web. <http://www.organiccenter.org/tocpdfs/NutrientContentReport.pdf>.

6. LaSalle, Tim, Paul Hepperly, and Amadou Diop. The Organic Green Revolution. The Rodalte Institute. <http://www.rodaleinstitute.org/files/GreenRevUP.pdf>.

7. Ibid.

8. To learn more about IAASTD, please visit: http://www.agassessment.org/ 9. Badgley, Catherine, and Ivette Perfecto. “Organic Agriculture and the Global Food Supply.” Renewable Agriculture and Food Systems 22.2 (2007): 86-108.

10. Gurian-Sherman, Doug. Failure to Yield: Evaluating the Performance of Genetically Engineered Crops. Union of Concerned Scientists. <http://www.ucsusa.org/assets/documents/food_and_agriculture/failure-to-yield.pdf>.

11. Benbrook, Charles. Impacts of Genetically Engineered Crops on Pesticide Use: The First Thirteen Years. The Organic Center, Nov. 2009. <http://www.organiccenter.org/reportfiles/13Years20091126_FullReport.pdf>.

Book Review, Andrew Thibedeau, p. 18 1. Lynn C. Klotz and Edward J. Sylvester, Breeding Bio Insecurity: How U.S. Biodefense Is Exporting Fear, Globalizing Risk, and Making Us All Less Secure (2009).

2. Kenneth King, Germs Gone Wild: How the Unchecked Development of Domestic Biodefense Threatens America (2010) 3. Klotz and Sylvester, supra note 1.

4. Alfred Jay Bollet, Plagues and Poxes: The Impact of Human History on Epidemic Disease (2004).

5. Biodefense: Research Methodology and Animal Models (James R. Swearengen ed., 2006).

6. Kenneth King, supra note 2, at 433 (2010) (quoting Scientists Working Group on Biological and Chemical Weapons, Center for Arms Control and Non-Proliferation, Biological Threats: A Matter of Balance (Jan. 26, 2010)).

7. Klotz and Sylvester, supra note 1, at 93 (emphasis in original).

8. Klotz and Sylvester, supra note 1, at 79.

9. U.S. Center for Disease Control statistics.

10. Crystal Franco, Billions for Biodefense: Federal Agency Biodefense Funding FY2009-FY2010, Biosecurity and Bioterrorism: Biodefense strategy, Practice, and Science, vol. 7, no. 3 (2009): 1-19.

11. Klotz and Sylvester, supra note 1, at 15.

12. Id. at 4.

13. Id. 14. Id. at 144.

15. Klotz and Sylvester, supra note 1, at 23. See also Laura A. McAllister et al, Superactivation of the Botulinum Neurotoxin Serotype A Light Chain Metalloprotease: A New Wrinkle in Botulinum Neurotoxin, J. Am. Chem. Soc., vol. 128 (2006): 41764177.

16. J. Jankovic, Botulinum Toxin in Clinical Practice, J. Neurol.

Neurosurg. Psychiatry, v. 74 (2004): 951-957.

“Flushing It Down the Rabbit Hole,” Andrew Thibedeau, p. 22 1. Pub. L. 107-56, 115 Stat. 272 (2001).

2 Pub. L. 107-188, 116 Stat. 594 (2002).

3. M. Beatrice Diasa, Leonardo Reyes-Gonzaleza, Francisco M. Velosoa,b, & Elizabeth A. Casmana, Effects of the USA PATRIOT Act and the 2002 Bioterrorism Preparedness Act on select agent research in the United States, Proceedings of the National Academy of Sciences 107, no. 21, p. 9556 to 9561 (May 25, 2005).

4. 42 C.F.R. §§ 73.3, 73.4 (2009); see also www.selectagents.gov (National Select Agents Registry Program).

5. Dias et al. 9558.

6. Dias et al. 9560.

7. Dias et al. 9557.

8. Bob Grant, Biosecurity Laws Hobble Research, TheScientist.com NewsBlog (May 10, 2010).

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