2/29 Berkeley Conference In Berkeley: Unmasking the Bay Area Biolab and Synthetic biology–Health, Justice and Communities at Risk http://www.synbiowatch.org/2012/02/unmasking-bay-area-biolab-dialogue/
Lawrence Berkeley National Lab and the Department of Energy plan to build a high-profile experimental laboratory in Richmond. While public pronouncements tell us the lab will focus on “green” energy research, the truth is more complex.
A primary focus of the new lab will be synthetic biology: an extreme form of genetic engineering that creates self-replicating artificial life forms from synthesized DNA. The development of these high-risk genetic technologies is largely driven by the oil, chemical, agribusiness, and pharmaceutical industries, the military, and other federal agencies, in a rapid, high-profit commercial race. But the risks synthetic biology poses to worker safety, public health, social justice, and the environment are poorly understood, and lack adequate oversight, transparency or protections.
Join us for a presentations and public dialogue on the expansion of the Lawrence Berkeley National Lab, the dangers of synthetic biology, and the local and global implications of this controversial industry.
• Nnimmo Bassey, Right Livelihood Award Winner (the Alternative Nobel Prize) (Nigeria)
• Maria José Guazzelli, Center for Ecological Agriculture (Brazil)
• California Coalition For Workers Memorial Day
• Injured Workers National Network
• Andrew Kimbrell, Director, Center for Food Safety
• Jeremy Gruber, President, Council for Responsible Genetics
• Jim Thomas, ETC Group
• International Center for Technology Assessment
• Global Justice Ecology Project
“When scientific power outruns moral power, we end up with guided missiles and misguided men.” – Martin Luther King Jr.
March 29th 2012
David Brower Center
2150 Allston Way, Berkeley, CA 94704
A Synthetic Biology Lab In Berkeley http://www.councilforresponsiblegenetics.org/GeneWatch/GeneWatchPage.aspx?pageId=346
A SYNTHETIC BIOLOGY LAB IN BERKELEY
By Jeremy Gruber, Tina Stevens, Becky McClain
In April of this year, U.C. Berkeley researchers announced the creation of the U. C. Berkeley Synthetic Biology Institute (SBI), which will ramp up efforts to "engineer" cells and biological systems.1 Part of its research will include experiments that insert manufactured stretches of DNA into existing organisms to create new, self-replicating artificial life forms-experiments that pose implications for worker safety, public health and environmental safety. A collaboration of university and industry, the SBI enterprise is designed to catapult basic research into profit making applications. From a press release, "SBI will be an important link in a constellation of research centers focused on synthetic biology at UC Berkeley and Lawrence Berkeley National Laboratory (LBNL), both of which have made the field a research priority. SBI is unique in its planned collaborations with leading companies, designed to translate leading research on biological systems and organisms efficiently into processes, products, and technologies."2
Where this extensive new research will take place is a matter of some speculation. LBNL, managed by U.C. Berkeley but funded by the Department of Energy, is seeking to open a second campus somewhere in the East Bay, across from San Francisco. The new facility hopes to combine three existing facilities presently scattered throughout the cities of Berkeley and nearby Emeryville: the Joint BioEnergy Institute, the Life Sciences Division, and the Joint Genome Institute. Potential sites for a new campus include a number of locations in the City of Berkeley itself.3
What do residents make of this idea? Lawsuits have stymied LBNL's effort to expand into the region's Strawberry Canyon watershed, described by activists as "a rich repository of wildlife."4 Now concern over second campus proposals, which include targeted locations along the west Berkeley shoreline, has centered on issues of job creation, tax revenues, zoning, and predictions of rising sea levels. It remains to be seen whether health and safety issues uniquely associated with this research also will be raised. Do adequate safety protections exist? Or are entirely new safety assessment and reporting methodologies for this research required in order to safeguard worker, public and environmental wellbeing?
Biosafety level (BL) containment labs are ranked from 1-4 according to the risk of harm they pose, with increasing levels indicating increasing danger. Typically, BL1 labs perform research on non-human infectious agents; BL2 labs use biological agents that could infect humans but are assumed to cause only "moderate harm"; BL3 labs experiment with biological agents capable of killing humans but for which there are known antidotes (like anthrax); and BL4 labs conduct research using agents that could kill humans and for which there is no known antidote.
Which safety lab levels will the new campus house? What constitutes "moderate harm?" Will the citizenry of this densely populated urban area know what pathogens are being used for research? Since academic and private interests operate under different safety, liability, and oversight restrictions, which research safety guidelines will apply? What remedies will apply in the event of lab worker injury, or environmental or public safety hazard? Will there be a public safety infrastructure facilitating transparency and accountability? Is the patchwork of voluntary regulatory guidelines from existing agencies adequate?
A brief review of just a few incidents of lab worker exposure to hazards suggests that even current biolab regulation and oversight is not adequate. These include Dr. Jeannette Adu-Bobie, who after visiting a New Zealand lab suffered a meningococcal infection from a laboratory strain causing loss of both legs and an arm; Ru-ching Hsia, a Department of Agriculture scientist who became infected by laboratory E.coli strain and lapsed into a coma for a month;, and University of Chicago scientist Malcolm Casadaban, who died after unknowingly being infected with a laboratory plague bacterium.5 One of this essay's co-authors, molecular biologist Becky McClain, won a whistle-blower suit against pharmaceutical giant Pfizer after reporting public health and safety concerns.6 She fell ill after an untrained lab worker used a human infectious genetically engineered virus, without suitable biocontainment, on McClain's personal workspace. She began experiencing periodic paralysis and spinal pain, a result consistent with the DNA-coded effects that had been engineered within the pathogen. Recently, researchers from the U.S. Centers for Disease Control and Prevention (CDC) reported that a University of Illinois laboratory worker was infected by a genetically engineered cowpox laboratory virus, one with which she had never worked. CDC investigators not only found cowpox DNA in many areas around the lab, they also discovered that supposedly harmless stocks of viruses had been contaminated.7 Problematically, releases of laboratory bio agents are difficult to track since exposures often are not visible to a worker who succumbs to a mystery illness. Scientists can become ill from dangerous biological exposures without knowledge of having endured an exposure.
Public health also is a serious consideration. Severe acute respiratory syndrome (SARS) killed nearly 800 people in 2003. Lab versions of the SARS pathogen are known to have escaped BL 3 and BL 4 labs via infected lab workers.8 And a few years ago, at Berkeley itself, workers handled deadly Rocky Mountain Spotted Fever (which spreads in the air) without containment when it was mislabeled as harmless.9 The U.S.'s 2001 anthrax scare10 and the unknown source of the virulent, antibiotic-resistant strain of E.coli that has recently infected thousands in Europe and, so far, killed 27 raise serious questions about the effectiveness of tracking, as well as accountability.11
There is no central authority that coordinates research and planning on synthetic biology. Even though synthetic biology poses serious risks, there are no specific standards for determining threat levels to humans, animals, plants, microorganisms or the environment. Experiments involving the synthesis of completely novel synthetic DNA sequences can make a harmless microbe into a new pathogen with dangerous and far reaching consequences. There are very real concerns that synthetic biology research could result in enhanced virulence, the ability to infect a wider range of organisms, and resistance to antimicrobials, antivirals, vaccines and other treatment or containment responses. As Jonathan Tucker and Raymond Zilinskas explain in "The Promise and Perils of Synthetic Biology," because synthetic microorganisms are self-replicating and capable of evolution, they could proliferate out of control and cause environmental damage and, if they escape from a research laboratory or containment facility, threaten public health. For this reason, they pose a unique risk unlike those associated with toxic chemicals or radioactive materials.12 Synthetic biology research also raises new issues regarding the degree to which laboratory workers are prepared to engage in such research. Synthetic biology is an interdisciplinary field, involving the activities of chemists, engineers, physicists, and computer scientists as well as biologists. Many practitioners in these fields have never had training, let alone professional experience, in biosafety13.
The most recent issue of GeneWatch featured Lynne Klotz's report on Boston University's feeble risk assessment efforts, undertaken to assure Boston citizens that its lab, which is likely to be conducting research on SARS and the deadly 1918 flu virus, is acceptably safe.14 The University and the NIH claimed that emergency simulations supported moving ahead with the desired research. The National Research Council did not agree, concluding that "the model did not appear to recognize biological complexities and reflect what is known about disease outbreaks and other biological parameters."15 In other words, both Boston University and the NIH had conducted a risk analysis that ignored the most basic information actually needed to assess the lab's risks. This cautionary tale should provoke additional public scrutiny of any new biolab facility. Berkeley's City Council, as well as the governing entities of the other Bay Area cities who want the lab, may want to keep track of what unfolds in Boston-remembering that Boston, unlike the San Francisco Bay Area, is not even on a major earthquake fault line. Considering the current limitations of oversight and the problems of accountability of the various public and private partners involved in the project, it is less than clear what steps they are prepared to take in order to ensure the safety of any new facility engaged in synthetic biology research.
Boosters have heavily promoted the theoretical benefits of synthetic biology to the public and local officials. They need now to be much more forthcoming in detailing the very real dangers attendant to such research, including broadly publicizing comprehensive risk assessments. Potential neighbors, and others who stand to be impacted by any facility conducting synthetic biology research, deserve better from the University and its partners, and from government representatives charged with protecting public health and safety.
Tina Stevens and Becky McClain are board members of Alliance for Humane Biotechnology. Jeremy Gruber is President of Council for Responsible Genetics.
1. "Lab, Campus Collaborate in Formation of Synthetic Biology Institute," Today at Berkeley Lab, April 21, 2011. http://today.lbl.gov/2011/04/21/lab-campus-collaborate-in-formation-of-synthetic-biology-institute/
; Synthetic Biology Institute, University of California, Berkeley. http://synbio.berkeley.edu/index.php?page=news-events
2. "UC Berkeley Launches Synthetic Biology Institute to Advance Research in Biological Engineering," Agilent Technologies, April 19, 2011. http://www.agilent.com/about/newsroom/presrel/2011/19apr-gp11012.html
3. "LBNL Announces Community Meetings on Second Campus at Berkeley Chamber Forum," The Berkeley Daily Planet, June 8, 2011.http://www.berkeleydailyplanet.com/issue/2011-06-8/article/37958?headline=LBNL-Announces-Community-Meetings-on-Second-Campus-at-Berkeley-Chamber-Forum-News-Analysis
5. "A Higher Bar for Pathogens, But Adherence Is an Issue," Andrew Pollock, NY Times, May 27, 2010. ttp://http://www.nytimes.com/2010/05/28/business/28hazardside.html?_r=1&scp=1&sq=Casadaban&st=cse
6. "A Roach in the Kitchen: Interview with Becky McClain," GeneWatch March/April 2010, vol 23, Issue 2, http://www.councilforresponsiblegenetics.org/genewatch/GeneWatchPage.aspx?pageId=248&archive=yes
7. "First U.S. Cowpox Infections: Acquired from Lab Contamination," by Sarah Reardon, Science Insider February 17, 2011. http://news.sciencemag.org/scienceinsider/2011/02/first-us-cowpox-infection-acquired.html?ref=ra
8. "SARS in the City," by Lynn C. Klotz, GeneWatch April/May 2011. http://www.councilforresponsiblegenetics.org/genewatch/GeneWatchPage.aspx?pageId=337
9. "Texas A&M Bioweapons Accidents More the Norm than an Exception," Sunshine Project July 2007. http://www.sunshine-project.org/publications/pr/pr030707.html
. (accessed 3rd of July 2011).
10. "Amerithrax or Anthrax Investigation" US Federal Bureau of Investigation. http://www.fbi.gov/about-us/history/famous-cases/anthrax-amerithrax/amerithrax-investigation
11. "German E. coli death toll rises further," CNN World June 9, 2011. http://articles.cnn.com/2011-06-09/world/europe.e.coli_1_ecoli-sprouts-sign-of-e-coli?_s=PM:WORLD
12 "The Promise and Perils of Synthetic Biology," Jonathan B. Tucker, Raymond A. Zilinskas, The New Atlantis, Spring 2006. http://www.thenewatlantis.com/publications/the-promise-and-perils-of-synthetic-biology
13 "Diffusion of Synthetic Biology: A Challenge to Biosafety," by Marcus Schmidt Systems and Synthetic Biology Journal (June 2008).
14 "SARS in the City," by Lynn C. Klotz, GeneWatch April/May 2011. http://www.councilforresponsiblegenetics.org/genewatch/GeneWatchPage.aspx?pageId=337
15 National Research Council (2007). Technical Input on the National Institutes of Health's Draft Supplementary Risk Assessments and Site Suitability Analyses for the National Emerging Infectious Diseases Laboratory, Boston University: A Letter Report, Washington, DC: National Academies Press. http://www.nap.edu/catalog.php?record_id=12073
. (accessed 3 July 2011).
16. The authors acknowledge helpful comments from Stuart Newman.
Dangers in Embryonic Stem Cell Research: Lack of Safety Oversight and Lack of Worker Rights & Becky McClain Presentation http://labornet.org/cgi-bin/ib/cgi-bin/ib.cgi?action=read&id=256
Source Becky McClain
Dangers in Embryonic Stem Cell Research: Lack of Safety Oversight and Lack of Worker Rights
By Becky McClain http://www.cpab.info director [at] cpab.info
THERE IS A SERIOUS problem in embryonic stem cell research, a problem that affects every American citizen, their safety and the safety of their children and the safety of their children’s children in generations to come. It is such an alarming problem that it should provide common concern even amongst Americans whose views have become polarized within the current embryonic stem cell controversy. It is a problem that has been unwittingly left out of the embryonic stem cell debate for far too long, and one that we no longer can afford to ignore.
This problem concerns dangerous recombinant (i.e. genetically-engineered) technologies being employed and developed within embryonic stem cell research, technologies that undeniably present a public health threat if left unchecked. Specifically, the problem centers around the lack of regulations and oversight in embryonic stem cell research with the creation of new human infectious genetically-engineered agents, the lack of worker rights in this industry and the repercussions from a biomedical community rife with conflicts of interest, which altogether present a serious public health threat.
The knowledge of this public health threat, encompassing lack of safety regulations and oversight, lack of scientist rights and impacts from deleterious conflicts of interest, comes from first-hand experiences while working on embryonic stem cell technologies as a career scientist within the research industry for 23 years. I have interacted with the biomedical community (i.e., government agencies, academia and private industry) in regard to safety issues and illnesses caused by exposures in an embryonic stem cell laboratory and retaliation for bringing safety issues forward. Through these experiences I have discovered bioethical and public safety issues which are being ignored and kept from the public knowledge. These issues play a big part in understanding the controversies associated with funding embryonic stem cell research and need to be brought to the public’s attention.
Dangerous technologies: With our current knowledge of molecular genetics combined with the sophistication of recombinant DNA technologies, we now have the scientific ability to easily create a variety of new human infectious agents that are designed to cause a specific human disease in embryonic stem cells through genetic engineering. In fact human infectious genetically-engineered viruses are being used to create disease-state embryonic stem cells in major academic and private research centers throughout the United States for biomedical research, drug discovery and biological “defense” purposes. Although it is somewhat troubling to realize that these dangerous embryonic stem cell technologies are being engaged for biodefense purposes, the majority of scientists, however, are employing them to advance the understanding for medical cures or for drug discovery. For example, in order to find a cure for a particular disease, a scientist must first make an embryonic stem cell “sick” or “diseased”. For this purpose genetically-engineered infectious viruses are created and developed to target the destruction of specific genetic or metabolic cellular processes and thus create a “defined” disease-state embryonic stem cell. Despite the fact that these agents are being employed for biomedical advances to help man-kind, these dangerous genetically engineered agents that can be infectious to both humans and animals, pose a serious public health threat by having the potential to contribute to new emerging disease if released into the environment and not handled and biocontained properly.
Our current scientific ability to create new infectious genetically-engineered microorganisms is remarkable and powerful. And although this serves great purpose for exploratory research, it also is obviously dangerous. For example, we now have the technical ability to make viruses expand their infectivity range to other cellular types and other species. One such technology that is currently being used in this manner for a variety of research projects in embryonic stem cell research is the HIV-derived lentivirus (yes, the one derived from the AIDS virus). In order to ensure entry into embryonic stem cells, HIV derived-lentiviruses have been genetically-engineered in the laboratory to promiscuously extend the “tropism” (infectivity range) to other species, as well as, to any cell type in humans, thus, providing this virus with the ability not only to infect by blood to blood, but also expands infection routes to inhalation and ingestion5. Increasing the infectivity range of a virus through recombinant technologies is just one example of how dangerous these genetic engineered technologies have evolved and consequently how they obviously present a public health threat if not regulated efficiently.
In addition to the dangers associated with our ability to increase the infectivity range of a virus, we also have the ability through standard recombinant technology to express any endogenous or foreign gene product inside a human cell via the virus resulting in an over expression of proteins or toxins that can cause metabolic disruption or disease. And with our ability to express gene products through recombinant technologies, we also have the ability to “silence” gene products which is yet another mode to cause metabolic disruptions in human cells. This “silencing” technology which is the product of the recent scientific 2006 Nobel Prize is being harnessed in embryonic stem cell research with the use of recombinant “molecular missiles”, called shRNAs. These “molecular missiles” can be easily created in the laboratory and cloned into viruses which then enables the virus to “search and destroy” targeted human gene products in any cell that it infects causing defined metabolic disorders to occur6. This “molecular missile” technology, as well as, technologies which over express gene products and toxins are standard tools used with embryonic stem cells to specifically create human and animal cellular “metabolic disease” models for research purposes. With the current ease and power of these technologies to create new infectious human agents and with the ever widening use of them in biomedical research laboratories throughout the United States, it should not be difficult for the average American to understand the public health threat that these present if not used, biocontained or secured properly.
A disturbing fact is that tracking genetically engineered viruses and the effects from a “release” into the environment is very difficult to assess. We unfortunately have no comparable “Geiger counter” available to detect biological releases as is used to detect harmful radiation release into the environment. Tracking these biological releases and their effect is almost impossible, strategically impractical and overtly expensive. This gives impetus for some scientists to inaccurately state that these technologies are safe because no harm has been detected to the general public since their development and use. But the truth may be that a physician who sees an atypical frequency of people in a small community with an unusual illness such as pancreatic cancer and finds it to be a mystery, may in fact, be seeing an illness possibly caused by a released genetically-engineered virus. Just because we do not have the “practical” technology available to track genetically-engineered infectious viruses and their effects, does not mean that no harm has occurred from them. And although some scientists might further argue that these viruses are “safe” because they are engineered to infect but not replicate, there is no real guarantee to this premise due to the promiscuity of viruses and their uncanny ability to “recombine” or swap DNA (genetic material) with a variety of organisms, providing the potential to create meaner, more resistant diseases or to create new emerging diseases over time. In fact, such genetically-engineered infectious viruses, when thought to be safe, unfortunately, have killed people in “controlled” gene therapy clinical trials7.
I have seen first hand where infectious genetically-engineered viruses were being developed without appropriate risk-assessments, were being used by untrained personnel, were not being properly screened for safe non-replicating infectious forms, and were not properly and safely contained within a certified biological containment hood. The consequence of all of this is release of these harmful agents into the environment. This not only poses a threat to small populations of people that may be exposed and become ill while unknowingly infected, but more seriously could contribute to a devastating epidemic of new emerging diseases over time. Many of these genetically engineered viruses contain “man-made” genetic elements that are not found in nature and are specifically used to cause genetic metabolic illnesses in humans or animals. Release of these “artificial” genetic elements into the environment basically accelerates the speed of evolution and thereby enhances the possibility and probability of a new emerging disease.
No effective oversight: Through my experience, I can assuredly tell you that the public’s safety is not protected against accidental, negligent or intentional misuse of genetically-engineered infectious agents developed for embryonic stem cell research in biomedical research. OSHA, NIH and state public health agencies that are responsible for laboratory safety practices within private and academic laboratory research, have no effective oversight regarding the use and biocontainment of dangerous recombinant (i.e. genetically-engineered) technologies used in embryonic stem cell research. One of the problems is that the OSH ACT1, which is the pertinent legislative frame work overseeing laboratory practices, was written prior to the biotechnology boom. It is an antiquated piece of legislation which was written mostly for chemical safety and, therefore, holds little relevance to the advanced biological technologies and laboratory practices being developed today. Secondly, local government authorities currently do not have the expertise or funding to effectively and knowledgably perform safety inspections within molecular biology laboratories that work on “state of the art” embryonic stem cell technologies. Thirdly, local government officials (i.e., Connecticut) and their jobs are often intimately tied to state-run programs to promote embryonic stem cell research which inherently provides unprecedented conflicts of interest toward special interest groups and the biomedical community2 and consequently, places public health policy secondary to the “economic development” of the state.
And although NIH sets biocontainment “guidelines“ (not regulations)3,4 for academic institutes that use federal funds for research involving recombinant infectious agents, there is no effective oversight to enforce these “guidelines”. Oversight is intra-institutional which of course is analogous to the “fox guarding the hen house” and which, consequently, does not provide incentive to protect workers, to publicize biocontainment “accidents” or to prioritize public health and safety.
Even more alarming is that private industries, such as biotech and pharmaceutical companies, which have no ties to federal funding are under no obligations whatsoever to legally and safely biocontain dangerous agents used in embryonic stem cell research since they are not under NIH jurisdiction or any other state or federal law. Historically, employers do not protect employees or prioritize public safety until compelled by law. Regulations and oversight are seriously and dangerously lacking in this area of research within private industry. This presents a real and serious public health threat.
No employee rights in the biotech industry: Employees who are exposed and become seriously ill from genetically-engineered infectious agents have no rights to exposure records and materials for their medical evaluation and treatment even after having physicians request this information for their healthcare. Under the facade of “trade secrets”, the biomedical community is refusing to advocate release of this information, thus leaving no avenue for “exposed” employees to secure appropriate healthcare and basically causing them to silently blend into the woodwork unseen and unheard of. This of course, keeps the biomedical community free of responsibility. It also keeps the public ignorant and unfortunately, continues to promote the façade that biotechnology and embryonic stem cell research are safe and carries no risk to the public.
In addition to the lack of appropriate medical evaluation and care for exposed employees, there are no laws that require the biotech and pharmaceutical industry to provide a forum to address safety concerns from scientists who work with these dangerous and emerging technologies. Scientist can be halted and silenced within safety committees with no recourse. Furthermore, there is no appropriate “whistleblower” law to protect workers in biotech industry. Scientists can be “legally” terminated after incurring biological exposures, subsequent illness and encountering hostility after raising safety issues. And when there are no adequate laws governing the safety practices of using embryonic stem cells and emerging technologies, then there is no legal recourse no matter how indecent this industry behaves. This is a clever way to continue to keep the public ignorant about the risks and dangers to public safety in an effort to self-promote this field of embryonic stem cell research. It also gives the biomedical industry free reign to develop dangerous technologies without the responsibility to safely use them, to protect against environmental release and to protect the public health. The lack of laws and lack of effective oversight in embryonic stem cell research equals a threat to public health and safety and serves as a dangerous precedent with today’s use of sophisticated genetically engineered agents.
Conflict of interest: Although I have compassion for Michael J. Fox and the suffering he endures from his illness, the face and the posture of the biomedical community involved in embryonic stem cell research are far from the altruistic and life-saving community that he portrays. The reality of the situation is that embryonic stem cell research in America is driven by money and power and, unfortunately, not by the altruistic desire to heal the general public of Alzheimer’s or Parkinson’s disease. Like it or not, this is the way of the world. The world of embryonic stem cell research is no different. Embryonic stem cell research is a money driven business.
The consequence of this money driven industry leads to a web of conflicts of interest resulting in a lack of real effective oversight in areas involving money allocation, patent royalty, medical ethics and women’s health issues10. It also leads to distorted public awareness of the true benefits that this research can provide resulting in a reckless frenzy to fund this research without first addressing these critical ethical issues.
Even more concerning is that academia and certain government agencies are so entrenched in large monetary interests to develop embryonic stem cell research with the pharmaceutical industry that there is no longer a group that is free of conflicts of interest to first protect and advocate for the public health and safety8,9. The lack of appropriate funding of both government-oversight agencies and basic academic research has resulted in an unhealthy monetary relationship to powerful pharmaceutical companies to the degree that public health issues are being ignored especially regarding the containment of dangerous genetically engineered technologies, as well as, to worker’s rights for medical exposure records and medical treatment. It is ironic that on one hand, the biomedical community promotes embryonic stem cell research as the future “cure all” to a variety of horrendous human diseases, but then on the other hand, refuses to advocate basic human rights and medical care to workers incurring occupational exposures from the very technologies they promote. This is a tell-tale sign of the integrity of this community and an unfortunate product of the conflicts of interest within this community. The biomedical community continues to hide and ignore the risks that embryonic stem cell technologies impose upon public health to promote their own agenda and to keep their investments safe. Education within medical schools and university settings regarding these technologies is lacking, keeping community physicians, local legislators and the general public in complete ignorance concerning these dangers. Unfortunately, when the biomedical community is entrenched in large monetary interests to develop embryonic stem cell research within an environment with no effective oversight and no legal responsibility, the consequences will be that public health issues will fall by the wayside.
Immediate regulations needed: The ease and power to manipulate the genetic characteristics of the embryonic stem cell through recombinant technologies holds much promise for biomedical advances, but unfortunately it is dangerous and becoming more dangerous with unregulated use. Scientists involved in human embryonic stem cell research know very well that embryonic stem cell technology holds little promise to find cures for illnesses in any near future. The lack of scientific breakthroughs in developmental biology pertaining to the “differentiation” of the human embryonic stem cell into therapeutic cell types, remains the weak link, and thus provides severe limitations to any therapeutic advancement in the near future or even far-off near future. Therefore, the rush to promote and fund human embryonic stem cell research without first implementing appropriate laws and oversight to regulate the use of dangerous recombinant technologies is not in the best interests of the public’s health and safety.
The adoption of new regulations that would ensure appropriate oversight to public safety and worker’s rights might also fortuitously serve as a template for creating appropriate bioethical oversights within embryonic stem cell research which is a concern for many Americans today as well. With the muscle and influence of the biomedical industry at present, however, it remains doubtful if the current administration or any new future administration at this point will be powerful enough to implement effective protections or oversights unless funding is used as leverage for change. Therefore, I unconditionally support President Bush’s veto on any legislation which advocates any funding or “loosening of restrictions” toward embryonic stem cell research.
Times have changed since the famous Asilomar Conference in 1975 where scientists met to mitigate the perceived risks posed by the newly discovered power of recombinant DNA technologies. Now after thirty years and subsequent prevailing advancements, the threats of using recombinant DNA technologies are no longer perceived but real. Accidental, negligent or targeted release of infectious genetically-engineered microorganisms that cause “disease” in embryonic stem cells can harm the public. Laws providing protection to the public health relating to the control and use of these dangerous recombinant technologies are out-dated or non-existent, triggering the activation of a time-bomb for an inevitable catastrophic event. Economic factors have also changed the way the government, academia and the pharmaceutical industry interact, creating deleterious “conflicts of interests” amongst this biomedical community and a scientific culture where economic self-interest inherently dominates over public safety and worker’s rights. The combination of our current economic culture, scientific advancements and lack of laws have made embryonic stem cell research increasingly dangerous to the point that millions of lives can be tragically affected by one simple careless mistake or even by an intentional act. These critical issues have been completely left out of the embryonic stem cell equation. Congress should act responsibly and prioritize public health and safety by implementing effective and enforceable regulations that address these issues before endorsing any further funding or lessening restrictions toward embryonic stem cell research.
If we remain irresponsible and continue to ignore the fact that dangerous embryonic stem cell technologies have the potential to create emerging disease and catastrophic pandemics, but nevertheless continue to promote embryonic stem cell research without first implementing effective oversight, we inevitably will face an ugly monster and a public health crisis costing us a higher price than one can imagine for generations to come. Despite the hope and potential that embryonic stem cell research may bring to biomedical advancements, unfortunately, within today’s scientific and regulatory environment, it currently poses a greater devastating health and safety risk to mankind than any perceived future medical benefit. It is a risk that the public should not have to tolerate.
1. OSH Act: http://www.osha.gov/pls/oshaweb/owasrch.search_form?p_doc_type=OSHACT
2. Stem Cell Gold Rush: State Board Rife With Conflict by Jesse Reynolds, Hartford Courant, August 20, 2006
3. Biosafety in Microbiological and Biomedical http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4toc.htm
4. NIH guidelines for research involving recombinant DNA molecules www4.od.nih.gov/oba/rac/guidelines/guidelines.html
5. Safety Considerations for Retroviral Vectors: A Short Review, Dr. Donald E. Mosier, TSRI Institutional Biosafety Committee Chair; DMosier [at] scripps.edu http://www.sf.med.va.gov/e3/image-library/research/forms/Biosafety/safety.pdf
6. Lee, JS et. al., 2004, Stable Gene Silencing in Human Monocytic Cell Lines Using Lentiviral-delivered Small Interference RNA J. Biol. Chem., Vol. 279, Issue 10, 9379-9388,
7. Marshal, Eliot, 2000. Gene Therapy on Trial, Science 288:951-957
8. Academic public private partnership program (ap4) deainfo.nci.nih.gov/concepts/AP4conceptU54.htm
9. Secretive Biodefense Legislation Moves Forward: Pandemic and All Hazards Preparedness Act ( (S. 3676), http://www.ombwatch.org/article/articleview/3598/1/1?TopicID=1
10. Jesse Reynolds, “Stem Cell Gold Rush: State Board Rife With Conflicts” Hartford Courant 8/20/06
Copyright March 10, 2007---not to be published without author’s written permission.
The "Nightmare at Pfizer "- Injured Biotech Worker Becky McClain Speaks at 2009 April 28, 2009 SF Workers Memorial Day http://blip.tv/file/2061380
Pfizer Biotech Stem Cell Researcher Becky McClain Reports On Health And Safety Dangers In The Biotech Industry.
The Nightmare at Pfizer: Injured Biotech Worker, Molecular Biologist Becky McLain, Speaks at San Francisco Workers’ Memorial Day, April 28, 2009
I want to thank you very much. I’m very honored to be here today to speak at Workers Memorial Day, to honor those who have been killed or injured or disabled on the job. I want to especially thank you Steve [Zeltzer] because biotechnology and nanotechnology and these advanced emerging technologies are subjects the public doesn’t know much about. So bravo to you for bringing this issue forward. I really do appreciate that.
I’m here basically to share my concerns about serious public health and safety issues and about workers’ rights issues, especially those that exist in embryonic stem cell technologies and basic laboratories that are using genetically engineered viruses and other genetic recombinant DNA technologies. These laboratories are run using these advanced technologies without any regulatory oversight. The dangers are being hidden from the public. I think it is time to convince the public of the dire need for health and safety protections for both the workers and the public.
Now I’m a molecular biologist. I have 23 years of research experience and a Master’s degree from the University of Texas School of Public Health and a Biology degree [Becky: Is that a B.A. or an M.A. in biology?] from Indiana University. I said I’m a molecular biologist. I don’t know if any of you know what that is. People confuse it with microbiologist a lot. But a molecular biologist studies the cell on a molecular level, manipulating DNA or RNA using assays of genetics, and analytical assays and cloning. You’ve heard the word “cloning,” I think.
I have a broad range of research experience in neurobiology, developmental biology, human genetic disorders, vaccine design, and embryonic stem cell technologies. And that’s where I was injured. I was injured [while working with] embryonic stem cell technologies at a Pfizer lab in Groton, Connecticut. I was employed there for nine years. During the latter part of my time there, from 2000 through 2004 I worked in mouse embryonic stem cell technologies, and I was a member of the safety committee. And as a member of the safety committee I saw rather interesting unsafe work practices and unsafe working conditions. For example, people found a virus where we eat and drink. It was a contained virus, but where we would go and eat lunch, there was a genetically engineered virus. We had problems with reporting out blood samples: human blood samples and monkey blood samples. And then a story was reported to me from this lady who had finished her lunch and she found a micro-centrifuge tube at the bottom of her Coke. Now as a safety committee member, I really knew the importance of documenting these things.
Most of our problems were a result of the design of our department. Remember I was working a Pfizer, but we had offices inside our laboratory at a computer, and also our department break room was in the hallway where there was a working hallway. So this was reasonably unsafe, because during times we couldn’t have personal protection—of course when you work with biologicals you wear gloves because you can get contaminated. So at times when you’d eat and drink there would be people walking around with biologicals or isotopes so it presented a problem. Some of Pfizer’s management’s response was a little bit odd. For example, one time I brought up an issue that there were some carcinogens where we eat and drink. I brought it up to this manager and said , “Hey, we need to work out this situation.” He said, “Well I was in graduate school and I had my hands in this and I don’t have cancer yet.” And there were these other kind of off-handed remarks—of course they were inappropriate—but I thought it was very bizarre. If I’m a manager, and someone came up and said that to me, I would try to remedy it as much as I can.
So I thought, “Is there a money issue here with upper management?” Basically I tolerated it for awhile, then a building blew up at Pfizer. The roof came off, the neighborhood was evacuated and it was a safety issue, so I thought, “Well hey, this is a time to go to upper management and discuss these issues about unsafe work practices in biotechnology. So I just wrote a letter and I said, “Could you explain the safety budget a Pfizer in response to these unnecessary risks that you’re putting people through with our offices inside the labs?”
They met with me finally after four months,and this is what they told me: they basically said that under OSHA standards it’s legal. Your unsafe work environment is legal. They said, “This is how it’s run. Pfizer’s safety budget is based on what is legal, and not necessarily on what is safe.” Several other departments had similar problems. (She was the head of environmental health and safety. She apologized. She said, “I’m sorry, but that’s how Pfizer’s run.”
In 2002 we had a mystery illness in the embryonic stem cell laboratory, where several people were becoming ill. There was vomiting, nausea, or headaches. And it happened over months…several months of continual exposures and illness. We finally pinpointed the source of the illness. It was the exhaust coming from a biological hood where we used mouse embryonic stem cells in genetically engineered viruses. We didn’t know what was going on, but we knew it was coming from the hood. Well Pfizer plugged the hood and just blew it outside into the Groton air. That was one of their trials to solve the problem. Apparently Pfizer thought this was legal. And allegedly Pfizer’s actions were again based on what is legal and not necessarily on what is legal and not on what is safe in regard to public health and safety.
So you can imagine that if we don’t have regulations on this industry, this is just the way of the world. The companies…it’s about money, right? It’s probably no only Pfizer, but it’s the bottom line. And if you don’t have regulations-- and historically this is known--then they’re going to have safety budgets that are based on what’s legal rather on what’s safe.
Now up to this point, to make a long story short, my continued safety complaints about unsafe working conditions had become unpopular. I was even told to stop documenting my safety concerns within the safety committee. Hostility and threats against my career ensued, with concomitant drops in my performance evaluations. Co-workers confided in me that they were afraid to speak out in regard to safety problems, because they feared retaliation. And unbelievably all this was happening and of course I was somewhat stressed out about being retaliated against—you know if you’ve ever been targeted-- but again, right at that time, I get another exposure to a genetically engineered virus that someone had been working on right on my personal workbench for a whole month, without my knowledge. And when I did find out, I asked them, “Well, what is the virus?” He had told me it was a lenti-virus, but he didn’t know anything other than that. So I said, “Will you please find out what it was?” Well he came back the next day and said “Oh, it’s safe,” and he inferred it wasn’t a human infectious agent, and he said there were no problems. But he said I need to disinfect, so he disinfected everything.
I didn’t think much of it, because if it’s not a human infectious agent you shouldn’t get ill from it. Everybody’s exposed to mouse viruses, but it has to be really a human infectious agent to set something off. I didn’t think too much about it. Unfortunately, right after that, I started developing a chronic illness, a slow progressively chronic illness so that I eventually had to go on medical leave, I was hospitalized, and I still have this illness today. It’s better maintained, but I still have it. Consequently, in 2004, with no other options, because Pfizer just would not negotiate about these issues, I had to report to OSHA. And Pfizer terminated me individually after reporting to OSHA.
Okay, now, every workplace has to have these OSHA posters posted. [Unravels poster and shows it to audience]. It says, [reads in ironic tone] “You Have a Right to a Safe and Healthful Workplace,” and in large red capital letters: IT’S THE LAW!” And it lists the statute, The Occupational Safety and Health Act of 1970 assures safety and healthful working conditions for working men and women throughout the nation. [Points to photos of workers at bottom of poster] I should have gotten a clue because of two things: first of all there are no scientists up here…I thought this was a scientist but she’s holding a big can of meat or a plate of meat with a butcher knife. But it also says here that “The rights listed here may vary depending on the particular circumstances.” So I will tell you the particular circumstances in the biotech area are that: you are not protected by OSHA.
This is a serious problem, because remember we’re working with biological agents and infections agents, and if you’re not protected by OSHA then the public really is not protected by OSHA. And I’ll got over this quickly: there are three things I went to OSHA for, just documentation: 1)first: we’ve got unsafe lab conditions; here’s the documentation, the documentation of what they told me to be quiet about in the safety committee. 2) Here’s documentation of people who have been ill. OSHA said “We don’t have jurisdiction to go in and do a safety inspection for you. Statute of limitations. Which I didn’t quite understand, because the place was still unsafe.
But they [OSHA] did tell me they thought I’d been discriminated against. They’re the ones who told me they thought I’d been retaliated against. So they said, “Wait: our investigator’s on vacation,” so I met with her a month later. She sat down with me and she said, “Becky, most likely OSHA will not bring this retaliation claim forward, because only one out of 200 claims they do bring forward…remember [protection against retaliation means] protecting the public health [when] scientists and physicians [can] stand up and say “Hey we’ve got a public health problem” and they don’t get fired. But only one in 200 that OSHA brings into court wins. And she said, “Becky, this is a very weak law. I can try and negotiate for you with Pfizer, but if that doesn’t work, nothing will happen. So she did, and nothing happened, and of course it [my case] was dismissed. Remember I was on the safety committee, the safety committee that was raising those issues ….
The worst part of it is that I did end up having a very, very serious illness. Initially, when it was developing, a doctor wrote in my notes that I had “post-viral syndrome.” I said I was exposed to some viruses, but they told me, they inferred they were non-human infectious agents. So I wrote Pfizer and I said, “Could you please let me know exactly what those viruses were?” and they wrote back, “What viruses?” You know, “What viruses?” So I knew, right then, that uh oh….So eventually I must admit that OSHA did help me force Pfizer to tell me the name of the viruses, because Pfizer was not cooperating. And sure enough, when that was disclosed, they were human infectious agents. And this was two years after the exposure.
If you are exposed to a chemical like formaldehyde at Company A or Company B. formaldehyde at Company A or Company b has the same chemical structure, so you don’t any information about the chemical structure if you’re exposed. You just need to know that you were exposed to formaldehyde, this is what is going to happen. If you get exposed to a genetically engineered virus, every virus is different, because they’re hand-made. So you need the genetic code, you need to know how it was cloned, you need to know how it was produced, to understand the characteristics of the virus. So I went to OSHA and said, “Hey, the name’s not the identity. You can name a virus anything.” This went all the way from OSHA Hartford, to Boston, to Washington, D. C. for a ruling. And it was ruled by our federal government at an OSHA level that trade secrets supersede a worker’s right to get those exposure records. Now this left me with no rights for medical care. This is a real serious thing. I don’t know if you folks want your biotech workers who have been exposed walking out into the public without a chance to get health care. Think about that right now. That’s very serious.
I went to other agencies. They were just as inept. Workers’ compensation also claimed they had no authority to order the release of my exposure records. So that was the end of my claim over there. The Connecticut Department of Public Health….remember I want you to know that here in California you have a $3 billion stem cell thing going on; in Connecticut we have a $100 million program, a lot less than you folks…we didn’t get vote on it like you did….The Connecticut Department of Public Health heads that [laughs] embryonic stem cell agency….They said they don’t have any jurisdiction over genetically engineered viruses. And embryonic stem cells and genetically engineered viruses, that’s what we’re using in there, which probably the public is not that aware of….NIH, NIOSH, CDC,  they were equally ineffective, and I couldn’t get help, so I was forced to file a federal lawsuit in an attempt to get my exposure records for my health care. I’m in discovery phase now, so I can’t give you too much specifics about that right now, but I’d like to let you know that after a doctor’s request, after a professor of genetics request, and even after the judge has ordered Pfizer to release those records, they still have not release those records. It’s interesting.
I just want to share this personal story not to garner any sympathy, but just to let you know that we really are in dire need of health and safety protections both for the workers and for the public in biotechnology. My story is not an isolated case. Last year David Bell was speaking. He’s a biotech workers who was exposed and who got sick. He had the same problems I had. He was exposed, he couldn’t get his exposure records, he had the same problems with workers’ comp, and biotech workers better realize that this is a major problem.
I want to go over the dangers of these technologies. We’ve had a talk about nanotechnology. I’m going to talk a little bit about genetically engineered viruses. I also want to say a few words about synthetic biology. Does anybody know what “synthetic biology” is? Synthetic biology basically means they are making new types of life.
They’re getting all these new genes and cloning them together and making new life. They also have the capability to synthesize in the lab any virus or any mean bug or bacteria or infectious agent that they want. These aren’t regulated either. I’m just telling you about that, because that’s the biotechnology that you need to be aware of ….when you read about the field.
Now let’s talk about genetically engineered viruses. Are you aware that genetically engineered viruses are being created in every common university, and biotech industry? I don’t think the public really realizes this. Why they using genetically engineered viruses? We need them to make things sick. Because if you make an embryonic stem cell line sick, or a mouse, you can add disease state models so that you can find the biochemical or the physiological mechanism of a disease, or you can look for drugs to help find [Becky, don’t you mean “cure?” ] the disease. Now that’s a legitimate use for a genetically engineered virus. But of course these are called “dual-purpose technologies” because you use them for good, and you can also use them for bad. If they’re making cells sick, and they’re making animals sick, they can also make people sick.
Now I’m talking a about BL-2 labs. Bio-level-2 labs, not bio-level-3 or bio-level-4 labs. Bio-level-3 and 4 are biological war, they calls them “biological defense labs. These are Bio-level-2 labs, in your backyard or your neighborhood. This is what’s going on. They’re making genetically-engineered viruses. It’s very common, like Betty Crocker cookbook as a matter of fact. It’s not a difficult technology.
Why are the scientists saying that these are safe? They’re saying it because they make them, theoretically, not to replicate. If they don’t replicate, they won’t cause a communicable disease. Well, theoretically, yes, that’s theoretically a good safety mechanism, but when they produce these in a BL-2 lab they don’t check to see if it’s replicating or not. So you don’t know, because they could find viruses, as you know with this Swine flu [you called it “Mexican flu, Becky] it has four separate genetic elements. How did they get those four separate genetic elements? It either recombined, or I don’t want to mention what you might be thinking (laughs)…it may be biotechnology, because it is a mystery how four distinct genetic fragments from human, avian, and two swine [elements] from different parts of the world got together from different parts of the world and they didn’t know that this was happening.
So they don’t replicate, in theory, [Berman rewrote this slightly] but in fact they might be replicating, because they just don’t know it, because they don’t test whether or not it’s replicating. What they don’t tell you is that even if they don’t replicate, they infect. Not only do they infect, but they permanently integrate into your DNA.
How sophisticated are these technologies? I’m just going to give you an analogy. You know of a naval ship with missiles on-board? You launch a missile and they have a GPS unit onboard? With those missiles we can strike a building in any country we choose to attack. We have that same technology on the molecular level, and we’re using that technology in common laboratories. We can target any specific gene and knock down a gene and cause a metabolic disorder. We can do this because we’ve sequenced the whole genome, and we know the genome. We can also produce toxins in viruses.
My job at Pfizer was to make traditional expression systems for embryonic stem cells . I wasn’t personally working with viruses. But my genetic systems could be inserted into viruses, where they could destroy a gene of interest and cause a metabolic disease to try and attempt to make a disease state model.
What are the dangers? There are two parts to this. Of course they can infect; that’s a danger. But we also have the capability of changing the tropism of a virus. The tropism determines how a virus infects. The HIV virus, in general has a protein coat around it, and that protein coat determines where it infects. So in general it infects into CD-4 and CD-8 receptors and a leucocyte. So basically you can get HIV by blood to blood. If someone sneezes on you, you’re not going to get HIV. You have to get a needle stick, if you’re working in a lab, for example, with HIV. But now we have the knowledge to strip the coat off any virus, and place any other viral coat on these viruses.
For example, we can take the HIV virus and place a rabies-like coat on this HIV virus. So now this HIV virus has the ability of infecting you through your eyes, or if you breathe it, or ingest it. . So that’s the danger of these. They might not replicate, but they are highly infectious. The other problem is that now because the tropism is so highly infectious, it not only infects humans, but now you have an HIV virus with this code that can infect insects and it can infect mammals. So now if you release it the environment, you’re in trouble.
What are the dangers if these are released into the environment by accidental negligence or intentional release? They include increased chronic illness, new emerging disease, metabolic disorders, cluster of cancer, and possibly, if it’s replicating, it could cause an epidemic. The other difficult part of a genetically engineered virus is that they’re difficult to detect. If they’re released and they’re not replicating, you might see a cluster of people come down with cancer, but you can’t find the virus, because it’s not replicating. So it’s a public health issue.
Let me quickly go over the regulations. Basically there are no regulations on this industry. They’re using “guidelines.” These guidelines are established through NIH, but unfortunately guidelines only impact academia. Whoever gets government money has to follow these guidelines. Guidelines are not regulations. They don’t have legal teeth.
Private industry has no guidelines. They say they follow these guidelines, but it they don’t, it’s not against the law. And as I told you, what does Pfizer do? Pfizer bases their safety policy on what’s legal, and not on what’s safe. So if they’re working under guidelines, they can do basically anything they want, legally, and you really can’t do anything to them.
Why is the scientific industry trying to avoid being regulated? Well they want to really have the freedom to do any kind of research without responsibility or liability. They say it’s going to halt science, and stop science if they pass regulations, but they want to go forward without any liability. They also don’t want to put the money into their facilities. Our problems at Pfizer could have been easily fixed by a bit of remodeling of the department to give us a safe break room and perhaps remove scientists out of office space where genetically engineered recombinant DNA work is going on. Also, they don’t want public scrutiny; they don’t want the public find out what’s going on with these dangerous technologies.
Who pays the price? It’s you, the public, and the biotech workers. It’s not the big scientists you see on TV, because they’re not in there with the gloves on hand really making the viruses. It’s me and other biotechnologists who have no rights to safety forums or stand up and say “Hey, there’s a problem” or rights to our exposure records.
What can the public do? I think you folks have to try and support regulations on this industry, know it’s for your own health. Whistleblower laws are among the most important things to do. If you don’t have doctors and scientists who can stand up and say “Hey, there are some safety problems in here,” you’ll never find out anything.
Transparency is essential. When regulations do come, you want to be able to see what’s going on. Stop giving money to large non-profits and universities that are doing this research until they commit to public health and safety standards. Scientists…I forget to mention this before….with these OSHA posters they should take a big Magic Marker at work and write “You are not protected!” This is the law, but you are not protected.”
And therefore, it’s so important for biotech workers to know that they should have a right to unionize, because these are big corporations you’re going up against, and big universities with endowments, and you need to unionize to get rights.
Let me just conclude with this: I hope I’ve shed light on an important issue which is really being kept from the public’s eye. And it’s really not mentioned in mainstream media: that is the dangers of genetically engineered viruses being created in BL-2 labs in your common universities without regulations. This lack of regulations has made for intolerable risks to worker safety with no freedom of speech, and a lack of rights to exposure records for their own health care. Again this is a human dignity and human rights issue. All of this creates an environment which keeps the public in the dark about the dangers of biotechnologies. We all want to support scientific discovery, but it constitutes a double-edged sword. Before promoting embryonic stem cell research and other advanced technologies with public funding, we must support changes in current regulatory landscapes that provide workers’ rights and effective protections for you and your family.
I want to end my talk and remind you that it is Workers’ Memorial Day and it is also International Workers Memorial Day. I want to honor Dr. Jeannette Adu-Bobi. In 2005 she was infected in a laboratory with a meningococcal vaccine. [Holds up large color photo of Dr. Adu-Bob. She had only worked seven days in a laboratory in New Zealand with unsafe work practices occurring, and she mysteriously came down with an infection. She ended up in intensive care and the infection was systemic. She lost her two legs, one arm, and on her remaining arm she lost some of her fingers. And I want to honor her, because she had broken the silence. This has to be hard for her to allow a picture to be taken. She really illustrates the difficulty that biotech workers and all the other workers I have heard speak today…what we have to go through when we have a workplace injury. I just want to say that after she became infected they took a culture and it was the identical bacterium that she had been working on in the lab. And officials still denied that it was a workplace injury.
 National Institutes of Health
 National Institute for Occupational Safety and Health
 Center for Disease Control