IPS Stem Cells: New Ethical Quandaries By Sally Lehrman

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When scientists learned how to turn back the clock in a young skin cell, to bring it back to an early-stage cell that could become any other type in the body, both they and ethicists rejoiced. The reprogrammed cell was pluripotent, much like an embryonic stem cell. Maybe even better, it also might be prompted to jump from one cell type to another.

One day, these induced pluripotent stem cells -- iPS cells for short -- might be able to correct any number of life-threatening and disabling conditions. Much sooner, these cells will almost certainly serve as extremely useful models for studying disease.

The researchers used viruses to deliver three to four new genes into the cell nucleus. And with the new information, the skin cells reprogrammed themselves. They behaved almost exactly like embryonic stem cells, which are derived from fertilized eggs. But with these reprogrammed cells, people thought, there would be no moral and political controversy. No embryo would be destroyed.

Recently, new studies have taken the work a step further. Researchers used synthetic RNA instead of viruses to get new instructions into the cell nucleus. This sped up the process and lessened the possibility of side effects such as cancer when the cells finally become a treatment for patients. (They're called RNA-induced pluripotent cells.)

But as researchers and ethicists take a closer look at these iPS cells, they are realizing that the issues posed are as thorny as ever. In fact, the issues may be even more urgent because the new techniques are so much easier and cheaper. The concerns fall into three main areas.

First, the possibility of human cloning from one person's skin cells or human reproduction from cells made into sperm and egg. The possibility is far-off, but real. Scientists already have reported progress that could lead to either. One could become a parent at any age, using tissue from someone either living or dead.

More immediate concerns have to do with control of the original tissue donation and the purposes to which it is applied.

For instance, privacy. Because of the desire to use these cells to study or treat diseases such as Parkinson's, juvenile diabetes or Alzheimer's, it will be important to know the donor's health history. The donor's personal information and health history must always be linked to the cells. It may be impossible to maintain donor privacy.

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IPS Stem Cells: New Ethical Quandaries - Santa Clara ...

Red Light, Green Light: The California Cloning and Stem Cell Laws

By Margaret R. McLean

The recent signing of stem cell and reproductive cloning legislation by California Governor Gray Davis demonstrates, once again, that the Golden State is ahead of the regulatory pack. The legislation includes a permanent ban on reproductive cloning and an explicit endorsement of stem cell research. The stem cell bill thaws the federally induced chill on such research by opening up opportunities and state funds for study of multipotent and pluripotent stems cells, including those produced by nuclear transplantation.

Both pieces of legislation are rooted in the post-Dolly national debate about cloning. As that debate was reaching impasse in 1997, California enacted a five-year moratorium on the use of cloning technology to produce a child.

As required by that legislation, California appointed a committee to evaluate the "medical, ethical, and social implications" of human cloning. That panel - on which I served - spent over two years listening to specialists and members of the public discuss how the state ought to respond both to the potential to produce cloned human beings through somatic cell nuclear transplantation and to the budding use of this technique to produce human stem cells. The committee's report was delivered to Sacramento in January.

The committee's unanimous conclusion to ban reproductive cloning - cloning to produce a child for rearing - rested chiefly on profound concerns for the physical safety both of the baby produced and of the gestational mother. But reproductive cloning raises many other significant social and ethical problems, including confusing familial relationships, psychological harms to the DNA donor, and commercialization of the family.

The use of nuclear transplantation technology in medical research - "non-reproductive cloning" in the advisory committee's report - raised neither these particular safety nor the relational concerns, and the committee concluded that it was justified by the potential to alleviate the suffering caused by diseases such as diabetes and Parkinson's. Such research, the committee recommended, ought be subject to state regulation and restricted to blastocysts of less than fourteen days. Strikingly, the committee championed regulations that would govern both privately and publicly funded research. Again, the decision was unanimous.

On 22 September, Governor Davis signed the first law in any state explicitly endorsing stem cell research "involving the derivation and use of human embryonic germ cells, and human adult stem cells from any source including somatic cell nuclear transplantation," with oversight from the institutional review boards. Embryos cannot be bought or sold. With another stroke of the pen, Davis signed the permanent ban on human reproductive cloning. This bill also mandates the formation of a nine-member state advisory committee to consider what the prior committee described as "dangerous or unwise applications of our new scientific knowledge of human biology."

The bills' roots in the advisory committee recommendations show that citizen panels can aid the legislative process. Now California must address federal attempts to criminalize the very research it just encouraged.

Margaret R. McLean is the Director of Biotechnology and Health Care Ethics at the Markkula Center for Applied Ethics.

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The California Cloning and Stem Cell Laws