Americas Stem Cell Mess

By Josephine Johnston America’s Stem Cell Mess Other countries have laws that provide researchers with legal and moral clarity. Modified From © Klaus Guldbrandsen / Photo Researchers, Inc. It’s hard not to feel sorry for American embryonic stem cell (ESC) researchers. Over the dozen years since the cells were first derived, they’ve been expected to meet federal rules that change with each president, research guidelines from the National Acad

By | October 1, 2010

America’s Stem Cell Mess

Other countries have laws that provide researchers with legal and moral clarity.

Modified From © Klaus Guldbrandsen / Photo Researchers, Inc.

It’s hard not to feel sorry for American embryonic stem cell (ESC) researchers. Over the dozen years since the cells were first derived, they’ve been expected to meet federal rules that change with each president, research guidelines from the National Academy of Sciences as interpreted by their institutions, and separate requirements from state and private funders. While the extremely restrictive policies of the Bush administration caused a number of alternative funders to step up to the plate, each comes with its own rules, restrictions, and reporting requirements. Labs with a mix of federal and private funding are required to account for the monies separately, leading to the somewhat absurd practice of color-coding lab instruments and workspace so that nothing paid for with federal money is used to do something federal policies prohibit.

The picture brightened last year when President Obama lifted his predecessor’s restrictions, allowing the National Institutes of Health (NIH) to release new guidelines for an expanded ESC research program. But this August, a judge issued a preliminary injunction putting that entire program on hold. NIH has appealed the decision, and as I am writing, the appeals court has lifted the injunction pending consideration of the full appeal. Right now is the perfect opportunity for the US government to finally put ESC research on a firmer legal—and moral—footing.

Extracted cells are not full embryos, so embryonic stem cell researchers have been able to spend federal dollars provided the cells were extracted using nonfederal money.

The injunction case was brought by two stem cell researchers who complained that NIH’s 2009 ESC research guidelines violated the law. (The plaintiffs work on adult stem cells.) Every year since 1996, the US Congress has included language in its budget bills prohibiting the use of taxpayer money for “research in which a human embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death.” At first blush, these words, known as the Dickey-Wicker Amendment, might appear to prohibit government funding of ESC research altogether, because ESC research necessarily involves the destruction of human embryos. Yet the US government has been funding some ESC research for nearly a decade.

It's time to openly acknowledge that proceeding with embryonic stem cell research means losing some embryos. With such acknowledgment, the United States can have a more honest and durable policy.

NIH, under the Bush and Obama administrations, has supported ESC research on the basis of a careful and quite narrow interpretation of the Dickey-Wicker Amendment. Scientists cannot spend federal money extracting ESCs, the government’s legal counsel reasoned in 1999, because for the embryo, extraction is destruction. But extracted cells are not full embryos, so researchers have been able to spend federal dollars studying ESCs provided they were extracted using nonfederal money. This is a nice legal argument, and it did the job for a while. But as the recent court case shows, it is not sturdy enough to support a multimillion-dollar, decades-long federal research program.

Some legal scholars have always been concerned that NIH’s interpretation of the Dickey-Wicker Amendment flouted the spirit of the law. And bioethicists have worried that even if it works legally, the interpretation is morally suspect. An ESC policy that won’t fund cell extraction is not free of moral responsibility for that essential step in the process. German law prohibits destroying human embryos but permits research on some imported ESCs. The result is that Germany essentially outsources the activity it finds morally objectionable—no German embryos were harmed in the making of this science.

A much better way to go about all of this is to be up front and honest about what the United States will and will not fund with taxpayer money. Under the kinds of laws and policies in place in the United Kingdom, Sweden, Belgium, Canada, and Australia, among others, the rules for research involving embryos are clearly spelled out. For example, Canada limits the research to embryos left over from fertility treatment. Other nations allow a great deal—the United Kingdom and Australia both permit cloning of human embryos, but everything has to be licensed, which allows for close review and national oversight of the research. At the very least, these laws provide ESC scientists with clarity and predictability.

The Dickey-Wicker Amendment is passed annually, which means that every year US lawmakers have a chance to tweak the language so that it won’t interfere with the country’s ESC research program. Another option is to enact legislation requiring the US government to conduct and support ESC research, which was passed by both houses of Congress in 2005 and 2007 but vetoed both times by President Bush. Neither of these options is politically neutral, but they shouldn’t be as difficult to achieve now as they once were. Public opinion polls show significant support for limited kinds of ESC research (no cloning; no creation of embryos for research purposes). And we already know from past political battles that the research has bipartisan support.

Some people are completely opposed to ESC research, while others have no qualms. But many are ambivalent. Maybe you believe that human embryos are different in a morally significant way from other human cells, even if you don’t think that they have the status of born humans, or even fetuses. Maybe you believe that what we do with human embryos is symbolically significant, that how we treat the earliest forms of human life says something about our underlying moral code. Or perhaps you just feel that diverse, multicultural nations function best when they minimize how often and how much they offend the deeply held religious and moral beliefs of a sizable number of their citizens. But maybe you also believe that the research holds great promise. University of Wisconsin scientist, James A. Thomson, who first derived ESCs from embryos, has said “if human embryonic stem cell research does not make you at least a little bit uncomfortable, you have not thought about it enough.” But he also thinks it is important work.

“A little bit uncomfortable” seems to be how a majority of Americans and their political representatives feel. And it is the position taken by many other nations that are active in ESC research but that also subject it to some limitations and to a transparent oversight system. The United States has decided to permit ESC research within its borders and to support some of the work with public funds. So it’s time to openly acknowledge that, at least for now, proceeding with this important and timely research means losing some embryos. With such acknowledgment, the United States can have a more honest and durable policy. And then ESC researchers can stop worrying about laws, regulations, and court orders and get back to worrying about culture conditions, tumors, cell differentiation, and all the other scientific puzzles that remain to be solved.

Josephine Johnston is a research scholar at The Hastings Center, an independent bioethics research institute in Garrison, NY. She has degrees in law and bioethics, and works on ethical, legal, and policy issues in assisted reproduction, psychiatry, and neuroscience.

J.M.K. Makdisi, “The slide from human embryonic stem cell research to reproductive cloning: Ethical decision-making and the ban on federal funding,” Rutgers Law J, 34:463-511, 2003.

D.S. Davis, “Restoring human embryonic stem cell research,” Bioethics Forum, published online August 31, 2010.

National Bioethics Advisory Commission, “Ethical Issues in Human Stem Cell Research,” Rockville, Md.: National Bioethics Advisory Commission, 1999:iv-v.

E. Parens, L.P. Knowles, “Reprogenetics and public policy: Reflections and recommendations,” Hastings Cent Rep, S1-S24, July–August 2003.

G.D. Fischbach, R.L. Fischbach, “Stem Cells: Science, Policy, and Ethics,” J Clin Invest, 114:1364-70, 2004.

M. Guenin, The Morality of Embryo Use, New York: Cambridge University Press, 2008.

Comments

Avatar of: anonymous poster

anonymous poster

Posts: 7

October 4, 2010

I'm not sure how changing the law would provide moral clarity since we are often reminded that you can't legislate morality.
Avatar of: anonymous poster

anonymous poster

Posts: 5

October 4, 2010

I pray for the day when James A. Thomson and others in favor of human embryonic stem cell research think about it enough to be totally uncomfortable. We were all embryos once. This is human life being destroyed, and just like other times in human history when human testing was performed without the knowledge or consent of the subject, it is indefensible. Where do you draw the line? Severely retarded? Criminal? non-German? Embryonic? My neighbor's embryo and not mine? For all the terrible decisions George W. Bush made while president, at least he got this one right. \n\nRead more: Americas Stem Cell Mess - The Scientist - Magazine of the Life Sciences http://www.the-scientist.com/article/display/57700/#ixzz11QFvHLxO
Avatar of: ROBERT HURST

ROBERT HURST

Posts: 31

October 5, 2010

"A much better way to go about all of this is to be up front and honest about what the United States will and will not fund with taxpayer money. Under the kinds of laws and policies in place in the United Kingdom, Sweden, Belgium, Canada, and Australia, among others, the rules for research involving embryos are clearly spelled out."\n\nThis would assume, of course, that our Congress was actually interested in solving the nation's problems as opposed to appealing to various interest groups in order to enhance their re-election chances. I fear the Congress is far more interested in re-election than in solving any of the nation's current crop of problems.
Avatar of: PAUL STEIN

PAUL STEIN

Posts: 61

October 5, 2010

While it is true that the cells contained in a human embryo are indeed alive, various religions have various definitions for just what human life is. So, when it gets right down to it, embryonic stem cell research does and does not destroy "a human life". Perhaps a more expansive discussion of the topic on the part of lawmakers is necessary.
Avatar of: Walter Helfrecht

Walter Helfrecht

Posts: 1

October 5, 2010

The United States Constitution implicity relies on the fact that a citizen or 'natural person' is one who is living, breathing and otherwise existing on his or her own with no assistance from an umbilical cord.\n\nOne is only accorded the freedom and liberty to pursue happiness if one is living and breathing after having been successfully gestated and given birth. The law cannot operate in any other way. Has there ever been a lawsuit brought against an unborn thing? Of course not. That should be plenty of proof that laws exist for living persons -- those living on their own outside of the protective environment of the womb.\n\nWhile some may find it morally wrong to use an embryo to carry out science, if the embryonic mass is given over to science willingly by the live adults involved in its formation, then all argument is moot. They have made the ultimate moral judgment that they wish to promote something beyond themselves so that others may eventually benefit. A more nobler moral position is hardly likely to show itself.\n\nDivine Providence gives to all the free will to do whatever is desired and our system of law assures (more or less) that those desires can be realized so long as they don't infringe detrimentally on any other's rights. The embryo and the unborn fetus cannot participate in the decision -- there is no level of self-awareness or understanding that would enable that participation -- therefore there is no interference with any right as afforded by our Constitution or civil law.\n\nEthics can usually be established in a written and approvable form and certain uses of the output from ESC research can be limited or banned outright through this method of rule making. Legislating morality, however, is something that is not certain nor objective and has never been able to produce the intended results whenever it has been tried.\n\nThose who are morally opposed to ESC research will always recoil when public ("taxpayer") funding is promoted. But it makes one wonder what their priorities would be if the ESC research was able to give those self same opponents a second chance for a better life.
Avatar of: anonymous poster

anonymous poster

Posts: 2

October 7, 2010

There are some really complex ethical and legal issues with adult stem cell research, which are not often discussed. I discuss this further here: http://theconsternationofphilosophy.blogspot.com
Avatar of: anonymous poster

anonymous poster

Posts: 5

October 8, 2010

I visited the link in the "Ethical and Legal Issues" letter below and have a few comments to make: First, it's not clear to me why we have to compare the performance of adult stem cells to embryonic stem cells and some clarification on that would be helpful. Second, I don't see the ethical issue of forming gametes from adult stem cells being much different from sperm/egg donation for IVF. Clearly, the donor should have the right to restrict the use of his/her cells.\n I know it may be a long time before we reach consensus on the morality of the embryonic stem cell question as well as the closely related questions of abortion and IVF. My beliefs are that human life should be respected in all its forms and, until we can reach consensus on the questions brought up by this article, we should take the conservative approach of non-action. By destroying life before resolving these ethical questions, we "Shoot first, and ask questions later."
Avatar of: anonymous poster

anonymous poster

Posts: 2

October 8, 2010

"First, it's not clear to me why we have to compare the performance of adult stem cells to embryonic stem cells and some clarification on that would be helpful."\nThe reason is that in order to know whether the adult stem cells are safe for therapeutic use in patients (e.g., do they elevate cancer risk?), scientists need to compare them to embryonic stem cells. \n\n"Second, I don't see the ethical issue of forming gametes from adult stem cells being much different from sperm/egg donation for IVF. Clearly, the donor should have the right to restrict the use of his/her cells."\nThe issue of informed consent for tissue donation is complicated. The legal requirements are not consistent for therapeutic and non-therapeutic contexts, and once tissue samples are deidentified it is much easier for scientists to use tissues without informed consent. Feel free to contact me via my blog to discuss this further. I can email you a more detailed piece I've written. I also recommend reading "Autonomy and Informed Consent in Biomedical Research" by Russell Korobkin for an in-depth look at these issues.
Avatar of: anonymous poster

anonymous poster

Posts: 7

October 13, 2010

"Has there ever been a lawsuit brought against an unborn thing? Of course not. That should be plenty of proof that laws exist for living persons -- those living on their own outside of the protective environment of the womb"\n\nThere certainly are lawsuits brought when an unborn is killed or injured, therefore they must have legal rights:\n"In addition to the 13 charges of premeditated murder and 32 charges of attempted murder, he could be facing an additional murder charge for killing the unborn child of PFC XXXXXX, one of Hasan?s victims who was pregnant when he killed her".\n\n

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