Wisconsin Stem Cell Now, Inc. President Ed Fallone appeared August 25, 2010 on Wisconsin Public Radio to explain why our organization supports federal funding of all forms of stem cell research — including embryonic stem cell research.  He particpated in a debate on the Joy Cardin Show where he discussed the impact of the Sherley v. Sebelius ruling in federal court, the reason why research using embryonic stem cell lines is both moral and ethical, and the current limitations of alternatives such as research using either adult stem cells or Induced Pluripotent Stem Cell lines.  The program can be heard on the Joy Cardin audio archive or by clicking the following link:

http://clipcast.wpr.org:8080/ramgen/wpr/jca/jca100825b.rm

On August 23, 2010, United States District Court Judge Royce Lambreth issued a preliminary injunction in the case of Sherley v. Sebelius.  As a result of the Judge’s ruling, the Obama Administration is temporarily prevented from using federal funds to issue grants funds under the Guidelines for Human Stem Cell Research promugated by the National Institutes for Health and finalized on July 7, 2009.  The ruling may be reversed on appeal, but in the meantime this is yet another roadblock that opponents of embryonic stem cell research have used in order to delay the progress of medical research in this field.

The lawsuit was brought by individuals and organizations that object to embryonic stem cell research on religious grounds.  However, the specific legal objection contained in the lawsuit is the argument that the July 7, 2009 NIH Guidelines are in conflict with the Dickey-Wicker Amendment, in which Congress prohibited the use of federal funds for research that destroys a human embryo.  Judge Lamberth ruled that the plaintiffs’ claims had a high likelihood of success, and that the language of the Dickey-Wicker Amendment was clearly in conflict with the NIH Guidelines.  Therefore, he issued the injunction prohibiting any further expenditure of federal funds pending further factfinding and a trial.

In our opinion, Judge Lamberth’s legal reasoning is conclusory and fails to accord the usual level of respect that federal judges give to agency interpretations of their governing congressional statute.  In particular, Judge Lambreth interprets the word “research” in an overexpansive fashion, with the result that he reads the Dickey-Wicker Amendment in a way that prohibits a broad swath of medical research far beyond the intent of Congress.

The most striking aspect of the opinion, however, is that it is the perfect illustration of how health care policy choices are being influenced by religious motivations and litigation strategy.  The search for medical cures must be driven by doctors and researchers, conducted under ethical guidelines, and supported by federal funding through the National Institutes of Health.  Lawsuits are a terrible way to determine our nation’s health care priorities.

Governor Jim Doyle has proclaimed Wednesday September 23, 2009 to be “Stem Cell Awareness Day” in Wisconsin.

In a Proclamation released by the Office of the Governor, Governor Doyle recounts the leading role that the State of Wisconsin has played in the field of stem cell research, calling it “a field that represents not just an exponential advance in the sum total of human knowledge but also a ray of hope for countless families in Wisconsin and around the world that struggle daily with chronic disease or illness.” The Proclamation also notes that “stem cell research has entered a crucial phase with clinical trials being planned around the world to test potential therapies and cures for many diseases and chronic medical conditions.” Finally, the Proclamation declares September 23, 2009 to be Stem Cell Awareness Day throughout Wisconsin and encourages all citizens to learn more about the science of stem cell research and to continue to support the efforts of Wisconsin researchers to transform laboratory successes into future cures.

Ed Fallone, President of the advocacy group Wisconsin Stem Cell Now, praised the Proclamation. “Many people mistakenly assume that the election of the Obama Administration erased all of the barriers to pursuing stem cell research. The reality is that medical research in the field is still greatly underfunded, and that the recession and the federal budget deficit have limited the available funding. Stem Cell Awareness Day serves as a reminder to the public that continued support and advocacy is necessary to realize the potential of stem cell research as a source of cures and drug development.”

The California Institute for Regenerative Medicine originated “Stem Cell Awareness Day” with the objectives of delivering information to the public about the science of stem cell research, raising awareness of the current state of research across all types of stem cell science, and conveying the future promise of stem cell science for a wide variety of therapies and diagnostic applications. “Stem Cell Awareness Day 2009 ” is being recognized nationally and internationally with events and proclamations on September 23.

Information about stem cell research and Stem Cell Awareness Day can be found on the website www.stemcellday.com.

Stem Cell Awareness Day will be recognized across the United States and internationally on September 23, 2009.  Stem Cell Awareness Day is about outreach and education.  As explained by the California Institute for Regenerative Medicine, the purpose of Stem Cell Awareness Day is to 1) deliver information to the public about the science of stem cell research, 2) raise awareness of the current state of research across all types of stem cell science, and 3) convey the future promise that stem cell science holds for a wide variety of therapies and diagnostic applications.  Learn more at www.stemcellday.com .

On May 26, 2009, Wisconsin Stem Cell Now submitted a comment on the National Institute of Health’s draft Guidelines for Human Stem Cell Research.

The NIH draft guidelines can be viewed online at http://stemcells.nih.gov/policy/2009draft.htm .

Wisconsin Stem Cell Now submitted the following comment:

NIH Stem Cell Guidelines
MSC 7997
9000 Rockville Pike
Bethesda, Maryland, 20892-7997

Dear Sirs:

I am writing on behalf of Wisconsin Stem Cell Now, Inc. to comment on the National Institutes of Health (NIH) Guidelines for Human Stem Cell Research (the “Proposed Guidelines”).  The Obama Administration is to be commended for lifting the ban on federal funding for embryonic stem cell research on lines derived after August of 2001.  The ban imposed by the Bush Administration needlessly delayed progress in the use of human stem cells to understand and treat many diseases and chronic health conditions.  Thank you for the opportunity to comment on the NIH’s Proposed Guidelines.  

Wisconsin Stem Cell Now is a nonprofit, nonpartisan organization formed five years ago.  Our mission is to educate the public about the science and ethics of all forms of stem cell research and to advocate on behalf of increased government funding for regenerative medicine.  We firmly believe that medical research using human stem cells, including embryonic stem cells, can be conducted ethically and morally and will lead to the alleviation of human suffering.  We also strongly support government sponsored scientific research against any artificial political or theological restrictions.  Wisconsin Stem Cell Now is proud of the numerous scientists and researchers in the State of Wisconsin who are among the nation’s leaders in this important field.

We are aware that the subject of embryonic stem cell research is controversial, and that many Americans of good faith have religious objections to this science.  It is common knowledge that opponents of embryonic stem cell research have organized a campaign to submit negative comments on the Proposed Guidelines.  This is their right under the law.  However, opponents of medical research go too far when they use the administrative process or the courts of law as a vehicle for delay and obstruction, rather than as a forum for presenting their views.  We urge the NIH to protect the integrity of its rulemaking process.  The agency should recognize and reject tactics that are designed solely to delay the implementation of any rules that include the federal funding of embryonic stem cell research.

The debate over the morality of embryonic stem cell research is often portrayed as a battle between science and religion.  In actuality, the debate is between religious sects that have varying theological beliefs regarding the point at which the developing human embryo becomes a fully formed person.  This debate among people of faith can never be resolved, because it is beyond human comprehension to know the answer.  What is clear, however, is that the federal government is forbidden from taking a side in this debate.  The Proposed Guidelines go far towards re-establishing the neutrality of the federal government on this question of faith.

There are two aspects of the Proposed Guidelines that are of concern to our organization, however.  First, the Proposed Guidelines establish a requirement that already created embryonic stem cell lines shall only be eligible for federal funding if grant applicants can fully document the consent of the donors of the embryos used to create the stem cell lines.  There is no ethical or practical reason to apply the comprehensive and specific consent requirement contained in the Proposed Guidelines to pre-existing embryonic stem cell lines.  The lack of documentation in the exact format anticipated by the Proposed Guidelines does not mean that the embryos were obtained without full consent, or that nonconforming consent procedures are unethical.  The consent documentation requirements contained in the Proposed Guidelines should only be applied to embryonic stem cell lines created after May 2009.

Second, the Proposed Guidelines do not provide for federal funding of any embryos created outside of the in vitro fertilization process.  The Dickey-Wicker Amendment prohibits the federal funding of the creation of embryos for research, but does not prohibit the funding of research using stem cell lines derived from embryos created outside of the in vitro fertilization process.  Therefore, the Proposed Guidelines could be amended to allow for federal funding of research on stem cell lines created using somatic cell nuclear transfer without contravening any congressional statute.

However, we have spoken with researchers in Wisconsin who believe that the Proposed Guidelines, limited as they are, will nonetheless allow them to conduct research using diverse genetic material and disease-specific stem cell lines.  In other words, the researchers that we have spoken with are not yet convinced that it is necessary to expand the universe of eligible stem cell lines beyond the excess embryos obtained via the in vitro fertilization process in order to advance the science.  Accordingly, while we believe that the limitation contained in the Proposed Guidelines is less than optimal, we do not currently advocate a different approach.

Thank you once again for the opportunity to comment on the Proposed Guidelines.  The hopes and prayers of millions of people are with the researchers performing this vital work.

Respectfully submitted,
 
Ed Fallone, President
Wisconsin Stem Cell Now, Inc.