Dangers in Embryonic Stem Cell Research: Lack of Safety Oversight and Lack of Worker Rights
By Becky McClain
www.cpab.info
director@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.
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
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 4th Edition http://www.cdc.gov/OD/ohs/biosfty/bmbl4/bmbl4toc.htm
NIH guidelines for research involving recombinant DNA molecules http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
Safety Considerations for Retroviral Vectors: A Short Review, Dr. Donald E. Mosier, TSRI Institutional Biosafety Committee Chair; DMosier@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,
Marshal, Eliot, 2000. Gene Therapy on Trial, Science 288:951-957
Academic public private partnership program (ap4) http://deainfo.nci.nih.gov/concepts/AP4conceptU54.htm
Secretive Biodefense Legislation Moves Forward: Pandemic and All Hazards Preparedness Act ( (S. 3676), www.ombwatch.org/article/articleview/3598/1/1?TopicID=1
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