Message from Bernard Siegel, Executive Director, Genetics Policy Institute (GPI) and Founder of the Stem Cell Action Coalition
The Election of November 2010 Produces Dire Consequences for Patients
Fresh from their election victories in November 2010 social conservatives in so many states have been re-igniting their efforts from prior decades to ban ethically responsible human embryonic stem cell research in the United States. Even states with preeminent bio-medical research institutions, such as Minnesota, seem to have no immunity to this multi-headed, multistate emotive attack. The platform of social conservatism underlying these efforts has also been recently buttressed by a patent law decision in Germany. In this edition of the Stem Cell Action newsletter we review the progress of these re-ignited efforts in the U.S. in the form of two pieces of recently proposed legislation in Minnesota and one in Oklahoma. And we also review the German patent law decision.
Both efforts in Minnesota are targeted at the use of SCNT to derive human stem cell lines – not only for reproductive cloning but also for ethically responsible research into the causes of human disease and the hunt for treatments and cures. Regarding reproductive cloning, the U.S. FDA has already interdicted this practice, a fact often overlooked. So, much of the hysteria relating to reproductive cloning concerns a practice already prohibited by an agency of the federal government. This was underscored in 2005 in an important article by Harvard’s Louis Guenin titled “a Proposed Stem Cell Research Policy” in the journal Stem Cells. Read the article here.
In the context of using human cell lines derived from SCNT for the study of disease and the discovery of treatments and cures, it can be argued that the second of the two legislative efforts in Minnesota discussed below – a proposed prohibition on funding for SCNT with human cells – merely copies funding policies in place at the U.S. federal level. But Minnesota’s effort to criminalize such research – the first of the two legislative efforts in Minnesota discussed below – goes well beyond current U.S. federal law.
SCNT has been recognized as a valuable technique for creating human cell lines that exhibit the characteristics of deadly diseases. Study of these laboratory models of human disease may significantly advance our understanding of the root cause of human disease, and their use in the discovery and development of drugs that may prove invaluable. It is still far too early to celebrate the success of this mission, but much promise remains. The merits and status of this research is set forth in a report of the California Institute for Regenerative Medicine (CIRM). Please read it here.
Proposed Ban of SCNT in Minnesota
Despite unprecedented economic woes and other priorities relating to local governments in crisis, the good citizens of Minnesota who may have been spending sleepless nights worried about biomedical research run amuck, can now rest easy, as Rep. Michelle Fischbach (R-Paynesville) has vowed to root out any would-be Dr. Moreau hiding out at the University of Minnesota in Bloomington, the Mayo Clinic in Rochester, and similar medical research facilities in Minnesota. Notwithstanding her self-admitted lack of scientific background, she is relentlessly pushing H.F. 998.
This proposed legislation bans the use of somatic cell nuclear transfer (SCNT) for purposes of human reproduction — a practice regarded as unethical by all responsible stakeholders. But H.F. 998 goes much further by also prohibiting the use of SCNT to derive human embryonic stem cell lines that are used solely for gaining an understanding of the root cause of various human diseases as well as discovering and developing drugs that can be used to treat them. Under the proposed law, scientists in Minnesota engaged in ethically responsible research with human cell lines that they derive from SCNT or who acquire such SCNT-derived cell lines from sources outside Minnesota would be subject to criminal prosecution for misdemeanors. The proposed legislation seems to completely disregard — hence, the dangers of legislation not informed by scientific literacy — that the stem cells from which these cell lines are derived have zero developmental potential as long as they are never transferred to a womb or womb-like setting.
Beyond this criminalization of scientists, H.F. 998 makes criminals out of any patient or healthy individual in Minnesota who, in the interest of contributing to societally significant and ethically responsible research, donates from the tip of his or her nose even a single skin cell utilized by a researcher to derive a cloned stem cell line for such research. Never mind that such donation and research may lead to better therapies or perhaps cures for diabetes, cancer, paralysis, spinal cord injury, neurodegenerative diseases such as Alzheimer’s and Parkinson’s, or other devastating conditions.
Let’s place H.F. 998 into some historical (or we should say “hysterical” context). This bill fans the embers of the cloning hysteria from a decade ago to advance the social conservative agenda that seeks to shut down embryonic stem cell research in the United States. If anything, it is surprising as to how this effort seems so 2003. Under the prevailing zeitgeist at that time, human reproductive cloning was something around the corner. Social conservative lawmakers were trying to stampede overly broad cloning bans, including international treaties, not only to ban reproductive cloning, but by definition, extend as well to SCNT for ethically responsible research into the causes of human disease and the discovery and development of treatments to meet sorely unmet needs – needs exemplified by not only great pain and suffering at personal and familial levels but also heavy economic costs to society.
When it became apparent that the would-be baby cloners were mainly publicity seekers and efforts at the United Nations to outlaw SCNT globally were successfully countered through advocacy and education, the fears of the apocalypse subsided. Unfortunately, the screaming winds of November 2010 on which H.F. 998 seems to be sailing along towards enactment have been muting the echoes of the voices of reason from the debate of the last decade – a debate which was to have ended on the winds of November 2008.
The current status of this debate in Minnesota is recounted in an excellent article by Andrew Birkey of the Minnesota Independent titled ‘Cloning’ ban proponents muddle facts in stem cell debate: GOP resists efforts to clarify whether ban is for 'therapeutic' or 'reproductive' ends. Read the article here.
The Additional "Back Door' Approach in Minnesota
Finding that the broad patient advocacy and scientific communities are quickly organizing to oppose H.F. 998, the social conservative strategists in Minnesota have pulled out all stops to force their anti-stem cell research agenda down the throats of their fellow citizens. Their most recent gambit — akin to the Dickey-Wicker Amendment at the U.S. federal level — is an amendment to the state’s proposed Omnibus and Higher Education Act that prohibits state funding of research on SCNT with human cells at academic institutions in Minnesota.
This amendment was introduced by the same state senator who introduced H.F. 998. The funding bill, with the SCNT ban embedded in it, passed on March 29. Here is the text of the anti-SCNT funding amendment:
No state funds or federal funds the state receives for state programs may be used to either support human cloning or to pay for any expenses incidental to human cloning. For purposes of this section, “cloning” means generating a genetically identical copy of an organism at any stage of development by combining an enucleated egg and the nucleus of a somatic cell to make an embryo.
If you are angry or upset at what is happening in Minnesota, write or call Governor Dayton and tell him to oppose this effort to ban SCNT for medical research. Ask him not to sign H.F. 998 or the Omnibus and Higher Education Act if it continues to contain the anti-SCNT research measure.
CALL GOVERNOR DAYTON AT:
Toll Free: 800-657-3717
Oklahoma House passes anti-stem cell bill
The Oklahoma House has made its stand. It recently passed by a vast bipartisan majority a bill that would criminalize embryonic stem cell research in the state. The final vote was 86-8. In an editorial, The Oklahoman mourns the bill’s passage as an “image buster” for the state, and said the legislature passed the bill based upon “emotions.”
In addition, The Tulsa World said “Also of no surprise were the self-congratulatory claims that the measure is all about valuing life. But in straining their arms to pat themselves on the back, the lawmakers backing the ban neglected to mention that the embryos they are so valiantly trying to protect will be destroyed anyway. They also failed to point out that before they're ultimately destroyed, these embryos could play a valuable role in alleviating the suffering of an untold number of human beings.” Read more from this Tulsa World article here.
Stem cell research proponents are counting on the sane heads in the Oklahoma Senate to bottle up this terrible law.
Echoes in Europe of Sherley v. Sebelius: The Meaning of "Human Embryo"*
Three weeks ago, on March 10, the Advocate General of the European Union’s Court of Justice, issued a non-binding preliminary opinion “in complete independence” on the question of the meaning of the term “human embryo” in the 1998 European Commission directive on the patentability of biotechnology inventions. This opinion concludes that “an invention cannot be patentable where the application of the technical process for which the patent is filed necessitates the prior destruction of human embryos or their use as base material, even if the description of that process does not contain any reference to the use of human embryos.” In a sense, this case may be the European version of Sherley v. Sebelius, the U.S. case where two adult stem cell researchers are seeking the U.S. federal courts to prevent the National Institutes of Health from funding research with cell lines derived from human embryonic stem cells, arguing that such funding is prohibited by the Dickey-Wicker Amendment, dating back to 1995.
The Advocate General’s non-binding opinion arises in the patent law case of Brüstle v. Greenpeace eV (European Union Court of Justice Case C-34/10). The German patent in question in this case claims isolated and purified neural precursor cells, produced from human embryonic stem cells, used for the treatment of neural defects. The application for this patent was filed in December 1997 by Dr. Oliver Brüstle (the director of the Institute of Reconstructive Neurobiology at the University of Bonn). In 2004 Greenpeace eV applied to the Bundespatentgericht (Federal Patent Court, Germany) to object to the patent, arguing that because the neural precursor cells referenced in the patent originated from fertilized human eggs, the patent violated the 1998 European Directive 98/44/EC on the legal protection of biotechnology inventions. This Directive prohibits the industrial or commercial use of human embryos, but does not define the term “human embryo”.
In 2006, the Bundespatentgericht agreed with this objection, and Brüstle appealed the consequent invalidation of his patent to the Bundesgerichtshof (Federal Court of Justice, Germany). Three years later, in 2009, the Bundesgerichtshof stayed the proceedings in order to refer to the European Court of Justice concerns “whether the exclusion of the human embryo from patentability concerns all stages of life from the fertilisation of the ovum or whether other conditions must be satisfied, such as the attainment of a certain stage of development.”
After opining that both the totipotent cells “represent[ing] the first stage of the human body” and the blastocyst constitute human embryos for purposes of the European Directive 98/44/EC, the Advocate General reasons that even though “pluripotent embryonic stem cells, taken in isolation, do not fall within the definition of an embryo, since, individually, they are no longer capable of developing into a complete human being…[i]t it is not possible to ignore the origin of these embryonic stem cells [and] inventions relating to pluripotent stem cells can be patentable only if they are not obtained to the detriment of an embryo, be that it’s[sic] destruction or its modification. To make an industrial application of an invention using embryonic stem cells would amount to using human embryos as a simple base material, which would be contrary to ethics and public policy.” (The Advocate General’s non-binding preliminary opinion regarding totipotent cells also extends to SCNT and parthenogenesis “in so far as totipotent cells would be obtained in those ways”.)
As a technical matter, the reference by the Bundesgerichtshof to the European Court of Justice of the question as to the meaning of the term “human embryo” is a means by which the Bundesgerichtshof can obtain an interpretation by which to align with European Union guidelines the ultimate decision on the appeal of the invalidation of the Brüstle patent, which the German Court ultimately must make. As noted in the March 10 press release announcing the Advocate General’s non-binding opinion, “The [European] Court of Justice does not decide the dispute itself. It is for the national court or tribunal to dispose of the case in accordance with the Court’s decision, which is similarly binding on other national courts or tribunals before which a similar issue is raised.”
Dr. Brüstle, quoted by Nature in a March 10 news article, views the Advocate General’s non-binding preliminary opinion as “the worst possible outcome”.
This same news article in Nature notes that a final decision from the European Court of Justice on the interpretative question referred to it “is expected within a couple of months,” but also notes that “few preliminary opinions are reversed.”
We recognize that this case only involves the validity of a patent, but as the Nature article suggests, a ruling that adopts the conclusions of the preliminary opinion may foretell “difficulties beyond the issue of patenting”, not only for stem cell researchers in Europe but, recognizing the importance of cross-border collaboration in stem cell research and its translation into regenerative medicine, on a global basis.
* We express appreciation to the members of the GPI Legal Advisory Board who contributed to this analysis.
The Stem Cell Action Coalition serves as an engine to unite the pro-cures community. It recognizes that human embryonic stem cell research must be a national public health priority at all branches and levels of government, both federal and state, not only as a matter of the medical health of the individuals who comprise the United States, but also as a matter of national financial health.
Already joined by 70 organizations, the Coalition sponsors a web site www.stemcellaction.org and is actively engaged in social media. We urge you to become a follower of the Coalition on Twitter (@StemCellAction). In addition, the Coalition publishes this online bi-monthly newsletter “Stem Cell Action News”. This newsletter is disseminated to a database of more than 40,000.
To forge a permanent and unparalleled community of conscience and commitment, the Stem Cell Action Coalition seeks to recruit hundreds of organizations nation-wide. Together we can speak with one voice, so our elected officials in the legislative and executive branches of government can no longer ignore our clearly spoken will: to protect and advance human embryonic stem cell research. Please take action today:
Visit www.stemcellaction.org and send a letter to your Congressional representatives to support stem cell research. Remember that we are in 2011 with a new Congress. Even if you previously sent a letter to Congress last year, it’s now time to inform the 112th Congress of your opinion.
Follow us on Twitter @StemCellAction and join our new Facebook community.
Demonstrate your organization’s support for stem cell research by endorsing the Stem Cell Action campaign. This simple gesture serves as an expression of solidarity with the organizations and thousands of families already supporting this promising field of biomedical research and clinical development, with a shared goal to alleviate human suffering. Please send us your organization’s authorization to post your logo on the campaign web site. Send the authorization.
Make an online donation to the Stem Cell Action campaign. Proceeds will be used to advance the campaign.
To reach the Stem Cell Action coalition, please call toll free at 888-238-1423 or email our director of public outreach, Alan Fernandez at firstname.lastname@example.org
Issue 7: April 1, 2011
- Subscribe to this Newsletter
- Forward this email to a friend
- Update My Profile/Preferences
- Stem Cell Action Website
- World Stem Cell Summit Site
- Genetics Policy Institute Site
Stem Cell Action Coalition
Act to Cure
Addi & Cassi Fund
The Adam Susser Foundation
A. Alfred Taubman Medical Research Institute
Alliance for Aging Research
The Alliance for Medical Research - TAMR Education For Life
Alpha -1 Foundation
American Academy of Neurology (AAN)
American Council on Science and Health
Americans for Cures Foundation
American Society of Hematology (ASH)
Association for Research in Vision and Ophthalmology (ARVO)
The Baby Alex Foundation
B’nai B’rith International
Ben's Stem Cell News
Brooke Ellison Project
California Hepatitis C Task Force
Californians for Cures
Cell Transplant Society
Center for Inquiry
Central Illinois Advocates for Lives Interrupted by Parkinson's Support Organization (CALIPSO)
Cerebral Palsy International Research Foundation
Children's Neurobiological Solutions Foundation
The Cody Unser First Step Foundation
Cystic Fibrosis Research Inc.
Determined 2 Heal
Diabetes Research Institute Foundation
Genetics Policy Institute
The Gwendolyn Strong Foundation
I Believe Incorporated
Interdisciplinary Stem Cell Institute (ISCI) Miller School of Medicine, University of Miami
International Center for Spinal Cord Injury at Kennedy Krieger Institute
London Regenerative Medicine Network
The Miami Project to Cure Paralysis
Michigan Citizens for Stem Cell Research and Cures
Missouri Coalition for Lifesaving Cures
Multiple Sclerosis Activism Foundation
National Hepatitis C Task Force
Nebraska Coalition for Lifesaving Cures
Neural Stem Cell Institute
New Yorkers for Advancement of Medical Research (NYAMR)
New York Stem Cell Foundation
Nucel (Cell and Molecular Therapy Center at the University of San Paulo, Brazil)
Roman Reed Foundation
Sabina Cohen Foundation for Stem Cell Research
Sam Schmidt Paralysis Foundation
Stand Among Friends
South Dakotans for Lifesaving Cures
Student Society for Stem Cell Research
Texans for Advancement of Medical Research
Texans for Stem Cell Research
Unite 2 Fight Paralysis
W.M. Keck Center for Collaborative Neuroscience
Wisconsin Stem Cell Now
WiCell Research Institute