Published Sunday, July 29, 2001, in the San Jose Mercury News
BY LISA M. KRIEGER | MERCURY NEWS
President Bush is expected to soon render judgment on whether federal money should be used to fund stem-cell research. Many of his conservative supporters -- and the pope -- are pushing him to deny funding for the research, which destroys embryos in the hope of finding cures for debilitating illnesses.
But overlooked amid the sound and fury of the stem-cell debate are U.S. patents Nos. 6,245,566 and 6,200,806, licensed to Geron Corp. of Menlo Park and covering human embryonic germ cells and stem cells.
Those patents are a reminder that no matter how the debate plays out in Washington, D.C., privately funded scientific work is the foundation of all stem-cell research -- and it will continue to move forward.
Denying federal money for researchers to use embryonic stem cells will not end the ethical struggle posed by the studies; it will simply create new dilemmas with which to wrestle.
If the federal government bows out of the field, the only venues for research will be privately funded university labs, biotech companies and fertility clinics. They are exempt from the rigorous scientific and ethical oversight of federally run research. And privately conducted research could result in the destruction of more embryos than publicly funded studies; competing companies don't share information and are likely to be conducting similar research.
Moreover, private monopoly of the field creates a philosophical concern by mixing commerce with the creation of human life. The marketplace, not the taxpayer-supported National Institutes of Health, would dictate the direction of future stem-cell research. While Geron-funded work uses only embryos that are discarded at abortion clinics or donated by couples using fertilization services, other businesses could readily move into the mass production of embryos for profit.
The ultimate question is not whether research will continue -- but with whom we should entrust the responsibility of this work.
Embryonic stem cells, tiny translucent dots, can be kept alive for months if given the proper food and shelter. They grow in a tightly knit cluster at the bottom of petri dishes -- and over time, morph into liver cells, heart cells and a number of other tissues. Someday, many scientists hope, the tissue could be transplanted into ill people to repair or replace failing organs or a damaged nervous system.
Those in support of the research say thousands of embryos are likely to be discarded anyway. (Many of these are created by couples with fertility problems who seek in-vitro fertilization. They create stockpiles of embryos because few embryos ever develop when placed inside the womb. Once a woman becomes pregnant, the extra embryos are often unwanted.)
Embryos as humans?
But some conservatives and religious leaders are against the research because removing stem cells requires killing the embryos -- which they consider very young humans. The anti-abortion community says the fear of an increase in private research does not justify federal funding -- and that private research should be shut down.
``The president needs to grow up and start regulating private research,'' said Scott Weinberg of the American Life League in Stafford, Va. ``He needs to let state officials pass laws to shut down this unseemly science.''
The isolation of stem cells has been made possible with Geron Corp. funding for scientists at the University of Wisconsin and Johns Hopkins University. The corporation also funds research at UC-San Francisco. The commercial rights to these cells are controlled by Geron and a non-profit company set up by the University of Wisconsin, which sells clusters of cells to scientists for $5,000 a sample.
Already, several companies are attempting to join Geron in the competitive business of creating stem cells -- and they have strayed into new areas of controversy. There was news July 12 that Advanced Cell Technology, a private firm in Worcester, Mass., had begun acquiring eggs from female donors for cloning experiments that also could produce new sources of human embryonic stem cells. Most startling was another announcement this month that researchers at the Jones Institute for Reproductive Medicine, a fertility clinic in Virginia, had purchased eggs and sperm to create embryos solely for stem-cell experimentation.
``This is exactly what happens when no federal funds are available: The Jones clinic creates its own embryos, ACT does its thing and other clinics and labs in the country will go their own way,'' said Thomas Murray, president of the Hastings Center, a New York-based bioethics think tank. ``I have no doubt that, right now, there are clinics saying, `What technique can I use to get headlines?' ''
Bioethicists and attorneys caution that there is likely to be resistance to any attempt to tightly regulate privately funded research. Because research could be considered self-expression under the First Amendment, the government must have a compelling interest before it can bring it to a halt.
But if the National Institutes of Health jumped into the field, it could wield enormous influence. The nation's largest funder of medical research, it would most likely become the largest buyer of stem cells for academic labs. Exerting the power of its pocketbook -- and the conscience of the nation -- it could set rigorous standards for the types of cells it would accept from companies and the kind of research it would support. The NIH also routinely solicits public and expert opinions on cutting-edge research.
Research done by a private company is a trade secret, receiving little of the oversight and public accountability that accompanies public research. While private labs and fertility clinics usually assemble ad hoc advisory boards to guide them through ethical quagmires, they don't operate in the open and don't always adhere to generally accepted standards of research.
Last March, for instance, the Washington Post revealed that privately funded doctors at the Saint Barnabas Medical Center in Livingston, N.J., touted the success of an experimental treatment to help infertile women -- but failed to mention that their perfect record of healthy births was attained because they had aborted a developing fetus with a rare genetic disorder. Another fetus created by the experiment, later miscarried, was afflicted with the same rare disorder. This, too, was never disclosed.
In contrast, data generated by NIH-funded research is subject to more rigorous disclosure requirements.
For years, there has been a congressional ban on federal funding for any research that destroys human embryos. Last August, the Clinton administration circumvented that ban, saying the National Institutes of Health could fund research if the cells had already been extracted from embryos. Bush suspended Clinton's guideline.
Parallel labs created
Universities that remain committed to stem-cell research -- seeking money and cells from private sources -- have adjusted to the uncertainty by creating parallel labs. Stem-cell work cannot be done in any laboratory that buys so much as a light bulb with government money.
At UC-San Francisco, scientists have suspended their study of embryonic stem cells until they move their research off-campus. This is because the university receives huge federal funding for the ``indirect'' costs of running its many labs -- such as electricity and janitorial service -- and administrators feared that any on-campus embryo stem-cell research would run afoul of the law. Nothing, not even a centrifuge, can be shared.
At the University of Wisconsin-Madison, scientists have complied with the law by setting up the private WiCellResearch Institute Inc., a subsidiary of the Wisconsin Alumni Research Foundation.
Faced with such difficulties, those who support embryonic stem-cell research worry that U.S. researchers might migrate overseas. The best and brightest young researchers could steer clear of the field altogether. UC-San Francisco has already lost its pre-eminent embryo stem-cell researcher, Dr. Roger Pedersen, to England, which has a friendlier attitude toward stem-cell research.
``If federal support for stem-cell research is not forthcoming, the risk exists that talented scientists will leave academic centers to seek opportunities in the private sector, or even overseas,'' said Dr. Haile Debas, dean of the UC-San Francisco School of Medicine. ``That would be a tragedy of the greatest proportion.''
Compromise position
Prominent bioethicists such as Murray, Arthur Caplan of the University of Pennsylvania and Boston University's George Annas urge a compromise position that would place the federal government in the bully pulpit, where it would monitor the use of cells -- but also free up funding.
The government could control research by saying, for instance, that it wants to restrict what kinds of embryos are used. Spare or damaged embryos might be permitted; embryos created for profit might not. The government could also limit the number of teams doing identical research, thereby reducing the number of embryos that would be sacrificed.
``The National Institutes of Health is the single most important medical research institution in the world. It has the most prestige and pays the most fully,'' said Hastings Center's Murray.
``If federal funding becomes available, it will attract responsible researchers,'' he said. ``The best scientists would much rather get federal funding than work with these outside operations.''
A decision to allow some federal funding would bring more control to the entire field and help establish restraints on private efforts as well, the ethicists say. Private companies would think twice before stepping too far outside federal policies.
The ethicists have also called for an independent review board, established by federal legislation, that would have authority over research on embryos.
Dr. James Thomson, the pioneering UW-Madison biologist who helped create this quandary by isolating stem cells from human embryos, is optimistic about the scientific future of stem-cell research, but sends a warning.
``In the fullness of time, the research will go forward,'' he said in an interview with the New York Times. ``The question is how quickly it will go forward, and where it will be done.''
LISA M. KRIEGER covers life sciences for the Mercury News. |
