How the Proponents of Amendment 2 Can Profit from its Success

James S. Cole, Esq., General Counsel, Missouri Right to Life

            Responsible scientists acknowledge that any therapies or cures from the use of embryonic stem cells produced by somatic cell nuclear transfer (SCNT) are decades away, if they ever come.  As a British scientist said recently, “One of the problems is that in order to persuade the public that we must do this work, we often go rather too far in promising what we might achieve… I am not entirely convinced that embryonic stem cells will, in my lifetime, and possibly anybody’s lifetime for that matter, be holding quite the promise that we desperately hope they will.”  Professor Lord Winston, stem cell expert and president of the British Association for the Advancement of Science, Lecture at Gresham College, June 20, 2005, www.gresham.ac.uk/printtranscript.asp?EventId=347.)

            If the cures that proponents of Amendment 2 stress so much are not close at hand, then why are they pouring so much money into its passage?  The cost of advertising for the Amendment through Labor Day, 2006, has already far exceeded the cost of any previous election campaign in Missouri.  What do the proponents hope to gain?
            The proponents themselves are not saying, but one may suggest an answer based on public reports and information.  There are good reasons to believe that the proponents hope to collect multiple millions of dollars in royalties from patented lines of human cells that are derived from human embryos.  Pharmaceutical companies will pay such royalties in order to reduce the huge costs and delays inherent in testing potential drugs under current FDA safety regulations.

            The United States recognizes patents on embryonic stem cell lines.  The U. S. National Institutes of Health reports that as of October, 2004, 38 stem cell patents had been granted that “encompass human products or processes,” while more than 200 applications for such patents were pending.  NIH, Regenerative Medicine 2006, Chap. 5, “Intellectual Property of Human Pluripotent Stem Cells,” page 1 (http://stemcells.nih.gov/info/scireport/2006report.htm).

            The U. S. Food and Drug Administration (FDA) says that the development of any new drug now requires at least $500 million and 8 ½ years of testing.  See its summary, “FDA and the Drug Development Process: How the Agency Ensures That Drugs are Safe and Effective,” February, 2002, p. 1 (http://www.fda.gov/opacom/factsheets/justthefacts/ 17drgdev.html).  A large part of the cost arises from the requirement to test potential drugs on at least two different species of animals.  FDA, “The New Drug Development Process: Pre-Clinical Research,” on-line at http://www.fda.gov/cder/handbook/.  Animal tests require acquiring and caring for live animals during the testing.  Moreover, animal tests are not very satisfactory for some drugs.  Testing potential pharmaceuticals on batches of human tissue cells, such as heart (cardiac) cells, would give more accurate and quicker results than animal studies.

            The National Institutes of Health has described how embryonic stem cells can be used in the testing of drugs.  It says that human embryonic stem cells can “provide material for testing that may improve the safety and efficacy of human drugs.  For example, new drugs are not generally tested on human heart cells because no human heart cell lines exist.  Instead, researchers rely on animal models.  Because of important .  .  .  differences between animal and human hearts, however, drugs that are toxic to the human heart have occasionally entered clinical trials [tests on humans], sometimes resulting in death.  Human ES cell-derived heart cells may be extremely valuable in identifying such drugs before they are used in clinical trials, .  .  .  .”   NIH, Regenerative Medicine 2006, Chap. 1, “Embryonic Stem Cells,” page 4 (citations and table omitted) (http://stemcells.nih.gov/info/scireport/2006report.htm).  It is not just human heart cells, but many types of human cells, that are expected to be produced by taking stem cells from human embryos. Id.  Harvesting the stem cells, of course, kills the embryos.

            The NIH does not explain why adult stem cells cannot be used for the purposes described, in light of the many ways that researchers have already proved they may be changed into other types of tissue cells.  That possibility does not appear to be important to those who want to use embryonic stem cells.

            Already, advertisements are appearing for just this use of human embryonic stem cells.  For example, Cellartis AB, a Swedish company, disseminates glossy color brochures on how its lines of human embryonic stem cells (“hES cells”) can save significant time and expense in developing drugs.  See www.cellartis.com, “The Human Embryonic Stem Cell Technology Platform: Drug Discovery” and “The Human Embryonic Stem Cell Technology Platform: Drug Discovery: Toxicity Testing.”

            The proponents of Amendment 2 are not slow to prepare for commercial exploitation of hES cell lines.  The Kansas City Business Journal reported on July 14, 2006, that the Stowers Institute for Medical Research had established two companies to handle the commercial side of discoveries made by the Institute’s researchers.  Rob Roberts, “Tech Transfer Plans Will Share Market,” Kansas City Business Journal (July 14, 2006).  BioMed Valley Discoveries, Inc., which is wholly-owned by BioMed Valley Corporation, an affiliate of Stowers Institute, will “patent, develop and market discoveries made at Stowers [Institute],” according to the report.

            It is clear that there are sound reasons to suggest that the proponents of Amendment 2 expect to profit in the near future from patenting hES cell lines and then selling the rights to use them for testing drugs.  Meanwhile, the cures that they advertise are decades away.  In view of unpredictable millions of dollars to be made from the sale of human embryonic stem cell lines produced by SCNT, one can see that spending $15-25 million to obtain complete legal protection for SCNT in Missouri is a business investment for the proponents. 

That such royalties will come at a fearful cost in human lives is for the citizens of Missouri to consider carefully on November 7.