Friday, March 09, 2007

Stem Cells Part X: Wrap up.

An enduring myth of the media goes like this: "President Bush's ban on stem cell research has crippled this lifesaving medical research, and made the U.S. noncompetitive." Or some such. What is the truth of the matter?

In August, 2001, President Bush gave an address on stem cells[1] in which he noted that there were already in existence some 60 human embryonic stem cell (hES cell) lines, and that "we should allow federal funds to be used for research on these existing cell lines..." The media spin began the next morning, when the Washington Post huffed that his statement was "the most restrictive use of federal money the administration could have permitted short of a ban."[2] This was technically true, but misleading, for the Bush administration was the first to specifically authorize any federal dollars for hES cell research.[3] Since 2001, taxpayers have spent over $122 million on hES cell research,[4] with $20 million in 2002, ramping up to $40 million for 2005, with estimates of $37 million in 2007.[5] And, even without using federal dollars, private money was able to finance the first human clone in the U.S. in November of that same year, 2001.[6]

Worldwide, 414 hES cell lines have been developed in 20 countries.[7] Seventy one are registered in the NIH Stem Cell Registry, with 22 available for research; these lines represent, more or less, the "original" lines funded by the federal government. In addition, at least another 144 U.S. cell lines have been developed using private money.[8] By the end of 2005, there had been 315 research papers published in the world scientific literature. One hundred twenty five of these originated in the U.S., the largest fraction of any country by a factor of three. Over half of these U.S. papers received federal money. The next closest contender was Israel (42 papers), followed by the UK (30) and Korea (27).[9] On a side note, the number of papers written about stem cells - their ethics, their legality, and whatnot - "far exceeds" the number of actual research papers[10]. The point is that the contention, "the Bush ban impedes hES cell research" is simply not true.

Conversely, there is a factor which does impede hES cell research and send it overseas: patents. As we saw in Stem Cells Part IV, Dr. James Thompson and colleagues at the University of Wisconsin published the first report on growth of stem cells in 1998.[11] In 2001, his group, acting through the Wisconsin Alumni Research Foundation (WARF), patented the process.[12] That means U.S. researchers must obtain a license, and pay a royalty to WARF, to do work on stem cells, which is "stifling industrial research and investment" and "diverting taxpayer dollars meant for research to pay for licensing fees."[13] Since only the U.S. recognizes the WARF patents, it also means much work, and dollars, go overseas. Although these restrictions have recently been eased somewhat, it doesn't "go far enough."[14] A second major patent was issued in 2004 to Geron Corporation for their process of growing hES cells feeder-free.[15] These two patents - WARF and Geron - "dominate most of the anticipated commercial use of hES cells in the U.S."[16] So, in the end, human embryonic stem cell research, if its being impeded at all, is being impeded by plain old greed, not by the "Bush ban".

In the Introduction to this series, I said that what we as a society decide about human embryonic stem cell research will have a greater impact on the civilization our children inherit than even the Griswold v. Connecticut contraception decision, and the Roe v. Wade abortion decision, had on the society we have inherited. Before going any further, let me be clear on what hES cell research is not about: It isn't about cures for diseases. I do not think any "cures" will come from hES cell research. Even if they were, that wouldn't make it moral, because the "cures" would entail the murder of living human beings. But I believe that it will prove too technologically difficult to direct the growth of the cells, but even if it does become possible, replacing damaged tissues won't correct the underlying problems that led to the damage in the first place. If the steering is worn out, continually replacing the front tires won't fix the old heap. Likewise with stem cells, and I'm by no means the first person to make note of this problem.[17] Although I don't believe that stem cells as such will pan out, I do think that they will represent a way station in the development of other human-based medical technology. I think that somatic cell nuclear transfer - cloning - will be perfected, and the cloned embryos will be grown to cloned fetuses, and these fetuses will then be farmed for their organs and tissues. The primary technological hurdle here is developing an artificial womb/incubator. Cloning will be used to develop human/animal chimeras and hybrids of all sorts which will have multitudinous uses in medical research and development. Finally, cloned embryos will have uses as human technology manufacturing platforms, flexible systems which can be used to develop any number of biotherapies. We are already seeing this in the human cell lines developed from aborted babies which are used to manufacture vaccines and biotherapies. There will be more of this in the near future, much more. So, I think therapeutic cloning and its derivatives have a bright future.

But that's not where the real money is. I believe the real growth area will be in recreational cloning: the manufacture of creatures for human pleasure. Unthinkable? Fifty years ago, two men getting married was unthinkable. We have already crossed the threshold and entered a bright new world: the era of humanity unrestrained, a civilization without God, the realm of the perfect technological barbarian. Welcome to the future.

Endnotes.
[1] President Discusses Stem Cell Research. Office of the Press Secretary, The White House 9 Aug 2001 Available at http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html
[2] Bush Backs Partial Stem Cell Funding. washingtonpost.com, 10 August 2001, Available at http://www.washingtonpost.com/wp-dyn/content/article/2001/08/10/AR2005033106452_pf.html
[3] Fact Sheet: President Bush's Stem Cell Research Policy. Office of the Press Secretary, The White House 19 July 2006. Available at www.whitehouse.gov/news/releases/2006/07/20060719-6.html
[4] From 2003-2006 Bush Administration - $122 Million to Human Embryonic Stem Cell Research LifeSite 7 Feb 2007 http://www.lifesite.net/ldn/2007/feb/07020704.html
[5] Estimates of Funding for Various Diseases, Conditions, & Research Areas. National Institutes of Health, 5 Feb 2007. Available at http://www.nih.gov/news/fundingresearchareas.htm
[6] First Human Embryos are Cloned in the U.S. washingtonpost.com 26 November 2001, available at http://www.washingtonpost.com/ac2/wp-dyn?pagename=article&node=&contentId=A14231-2001Nov25
[7] Guhr A, Kurtz A, et al. Current state of human embryonic stem cell research: an overview of cell lines and their use in experimental work. Stem Cells 2006; 24:2187-2191.
[8] ibid, pg. 2187
[9] ibid, Figure 2
[10] ibid, pg. 2189.
[11] Thomson, JA et al Embryonic Stem Cell Lines Derived from Human Blastocysts. Science 282:1145-1147, November 6, 1998.
[12] U.S. Patent Office patent #6,200,806, issued 13 March 2001, to JA Thompson for Primate Embryonic Stem Cells.
[13] Foundation for Taxpayer and Consumer Rights & Public Patent Foundation Request for Reexamination of U.S. Patent No. 6,200,806. Available at http://www.pubpat.org/assets/files/warfstemcell/806Request.pdf
See also Public Patent Foundation, http://www.pubpat.org/warfstemcell.html

[14] Wisconsin Group Eases Stem Cell Patent Restrictions After FTCR-PUBPAT Legal Challenge. Public Patent Foundation http://www.pubpat.org/warfstemcelleased.htm
[15] Bodnar, AG et al, inventors; Geron Corporation, assignee. Methods and materials for the growth of primate-derived primordial stem cells in feeder-free cultures. U.S. Patent No. 8,800,480. 2004 Cited in "Regenerative Medicine 2006", National Institutes of Health, Department of Health and Human Services Entire report downloadable in pdf format at http://stemcells.nih.gov/info/scireport/2006report. See ref. 3, Chapter 5.
[16] Regenerative Medicine, ibid, pg. 54.
[17] Bobbert M. Ethical questions concerning research on human embryos, embryonic stem cells and chimeras. Biotechnology Journal 2006, 1:1352-1369. See in particular the discussion on pg. 1357.

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