Democratic Underground

The Stem Cell Plot Thickens
August 16, 2001
by Ramsey Harris, MD

On Thursday August 9, Mr. Bush made a long anticipated (especially given all the hype his staff created about his hours of ponderous study) announcement as to whether he would allow the federal government through the National Institutes of Health (NIH) to fund research involving human embryo stem cell (ESC) lines. The issue came under his scrutiny because former President Clinton had decided that the cell lines did not fall under a law passed by Congress prohibiting government funding of research that would harm or destroy embryos. The Department of Health and Human Services ruled in 1999 that ESCs were not themselves embryos and therefore the NIH could fund grants involving their use.

Since that time, the NIH convened a panel to determine whether each cell line complied with the ethical standards. The NIH was poised to fund grants when Bush took office. Mr. Bush had promised not to allow any federal funding of research involving human embryos. As recently as May 18, in a letter to the Culture of Life Foundation, he wrote: "I oppose federal funding for stem cell research that involves destroying living human embryos. Now suddenly, "involves" differs from "involved", evidenced by Bush's final decision to allow funding for research limited to existing cell lines. Mr. Bush is learning to parse, wiggle and squirm with the best of them. This fence-straddling extravaganza has been called Clintonesque. So where did it originate?

Bush had a major dilemma: upset the right-wing pro-lifers that he made a campaign promise to, or upset the scientific community, the biotechnology sector and the general public that overwhelming favors the concept of allowing research on clumps of cells that will never be human beings. As reported by Newsweek, Karl Rove had been floating the "existing cell lines" compromise since around June. After two to three months of carefully leaked stories about how Bush was wrestling mightily with the moral and ethical dilemma of ESC funding, even suggesting that a man with a usual attention span of about 15 minutes for any given topic, was "obsessed" with learning all about stem cells, the Bushies felt they had a safe albeit tepid solution.

Bush met with bioethicists Leon Kass and Daniel Callahan on July 9 to make sure he got the conservatives' favorite embryo thinkers on board. The NIH was ordered to find out how many cell lines existed in early July. They found about thirty. Bush told them to look again, and within days, they somehow found thirty more. Not enough for ever, but maybe enough for a few years, until it isn't Bush's problem anymore. Of these only ten to twelve have been reported on in scientific literature, and perhaps another ten have been described at scientific meetings. You can bet the NIH didn't have time to test those additional thirty or so cell lines in the few days Bush gave them to dig him up a more palatable number.

The problem is that thirty to sixty cells lines are only enough for maybe two to three years. That might give Bush time to get re-elected before he has to visit the issue again, but it doesn't address where to go when all the existing cells have petered out. The first human cell lines were cultivated in only 1998 and work on their growth characteristics is just beginning. The ESCs may not be truly immortal. Indeed, of the existing thirty to sixty cell lines, only a few are stable. Dr. Doug Melton, a leading researcher in the field, has access to several cell lines created in Israel, only one of which is consistently useful. Many have a tendency to differentiate spontaneously, making them useless for study. Of the six cell lines owned by Geron, a biotech company that has done the most work on stem cells, only two are available for distribution, also because of stability problems.

The promise of ESCs is their ability to differentiate into all types of cells, and the potential to regenerate organs or organs functions. Thus they are considered promising avenues for treatment of diverse diseases from neurodegenerative disorders, like ALS and Alzheimer's, to organ failure diseases like diabetes. For example, very early results show that the cells may migrate to the appropriate parts of the brain, establish synapses and grow there. But there is also a need for enormous genetic diversity and cell lines of varying properties on order to develop treatments for human diseases.

So, perhaps somewhat surprisingly, Mr. Bush agreed that the research and potential to alleviate human suffering is great. He thought he had a compromise that would appease his supporters on the right by refusing to allow any more embryos to be destroyed. So far this seems acceptable to all but the most intractable pro-lifers. Scientists generally feel that the funding promised is woefully inadequate, but are willing to take a few crumbs rather than the nothing they had feared. But is that all there is to this decision? With GW, you know you always have to consider what corporate or personal ally's interest is at play. In this case, it is as close as his very own head of Health and Human Services, Tommy Thompson.

This former governor of Wisconsin is known to be a hard-line abortion foe. He is also, however, a strong supporter of embryonic stem cell research. Inconsistent? Hypocritical? Perhaps, but understandable. The University of Wisconsin is one of the nation's academic leaders in ESC research, and holds the patents on at least five of the known ESC lines, cultivated by faculty member, Dr. James Thomson. It is also the home of the Wisconsin Alumni Research Foundation (WARF). Founded in 1925, the WARF is a private not-for-profit entity, the oldest and one of the most successful of all university intellectual property organizations. Through the management of a large intellectual property portfolio and the investment of royalties and licensing fees, WARF has created an endowment that returns on the order of $20 million annually to UW-Madison for unrestricted use in research and education. Stem cell lines are one of their big products.

WARF established the WiCell Research Institute in October 1999 specifically to advance their stem cell research through their own departments and through the distribution of cell lines. The institute's only faculty member is Dr. Thomson, and he currently lists no collaborations. Through WiCell, one can license five human ESC lines, on which the patents are listed as "applied for" on the company's website. Academic researchers may obtain a sample of human cells for $5000. For-profit labs will pay an unspecified initial and annual maintenance fee. However if one searches the US Patent Office online database under "Patent Applications," last updated August 9, 2001, there are only two applied for patents for human ESCs listed, neither one of them by Dr. Thomson.

Of the current US approved patents for human embryonic stem cells lines, two are held by Dr. James Thomson from University of Wisconsin/Wisconsin Alumni Research Foundation, two by Dr. Gearhart at Johns Hopkins University, and one by Dr. Hogan at Vanderbilt University. Dr. Thomson derived his cell lines from IVF embryos that were donated by the couples to his project. Dr. Gearhart's cells came from "8-11 week human aborted fetal material" according to his patent grant. This is where the corporate interest enters the picture. The Geron Corporation website lists the patents they hold. They list two patents by Dr. Thomson, and the two patents of Dr. Gearhart. Thus Geron Corp. holds the licensing or distribution rights to probably all of the existing US ESCs.

MSNBC has an editorial by Dr.Glenn McGee from the University of Pennsylvania Center for Bioethics, who says: "President Bush's compromise pads the wallet of a few - perhaps only one or two - companies. A large percentage of the revenue that will come from federally funded research on existing stem cell lines will end up paying for these companies' patents on stem cell research.… Former Governor of Wisconsin Tommy Thompson, now Secretary of Health and Human Services, helped to create the most important owner of this research, the University of Wisconsin Alumni Research Foundation. [Ed-Thompson likely did not help create WARF which was founded in 1925, but perhaps he was instrumental in the establishment of WiCell, or the stem cell division specifically.] WARF… may stand to build a research empire from the royalties and "reach through agreement" that ensures that it owns essentially anything created from its cells. If embryos discarded after IVF had been used, Wisconsin would have made little from stem cell research. Instead, under Bush policy, there will be a tariff on any research and it will be gathered almost exclusively by the home state of one of his senior cabinet officials." Dr. McGee doesn't mention the cell lines from Johns Hopkins also licensed by Geron. Perhaps these are to be excluded from Bush's funding proposal, since they were derived from aborted fetuses.

On August 13, 2001, WARF filed suit against Geron Corp. WARF and Geron signed an agreement in 1999 in which Geron had the rights to the five cell lines and six types of cells that are derived from them. Remember that stem cells can differentiate into multiple different cell lineages. This differentiation in culture depends upon what specific nutrients or cytokines are added to the culture media. It seems as if they had only worked out six differentiation pathways or culture conditions at the time the agreement was signed. An option to add cell types to the deal expired July 31, and negotiations to extend it failed, according to WARF. Geron says it still has the right to add cell types, and that it asked to do so on July 26. WARF wants to stop Geron from working with other companies to develop additional cell lines.

Clearly, Mr. Thompson's home state institution will benefit enormously, and perhaps even exclusively, from the $250 million set aside currently for stem cell research. Especially if they win the right from Geron to distribute future cell types derived from Dr. Thomson's five stem cell lines. And now with their cell lines going out to every NIH grantee, the University of Wisconsin stands to make a bundle of money too.

So when was Mr. Bush's speech? August 9. After the deadline for the expiration of licensing agreement between Geron and WARF/WiCell. Coincidence? Maybe this was one of the reasons for the timing of the speech. Bush made his decision over a month ago. Bush apparently always planned to make the announcement in August, after the Congress recessed, and on his home turf in Crawford. Early enough in his vacation to make it look like he was working, but allowing time for the expected furor to die down before he returned to the heightened scrutiny of DC. In the meantime he met with the pope as a token gesture to the Catholics, who mostly support ESC research in the US anyway.

With the level of orchestration that has gone into this whole circus from the very beginning, can anyone doubt that Mr. Thompson kept Mr. Bush informed as to what timing he preferred, or that WARF and WiCell knew did not know exactly when that announcement was coming? Was the announcement delayed so that WARF could allow their deal with Geron to expire? After all, if they could expect a large influx of government grant money in the near future, they wouldn't need private funding any longer. So why give up the rights to distribute and sell future cell products. What about those pending patents for WiCell, and when were they applied for? And has anyone bothered to ask the most basic ethical question of all: is it right to profit from human cells, especially those derived from donated embryos intended to help alleviate suffering?

References:
Ramsey's Stem Cell Primer: http://ramsey.dca.net/escprimer.htm
http://www.wisc.edu/warf/
http://www.geron.com
https://www.wicell.org/index2.html
http://www.reuters.com/news_article.jhtml?type=sciencenews&StoryID=158373
http://www.msnbc.com/news/611850.asp
http://www.msnbc.com/news/612806.asp

 
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