National Developments

Of course, my colleague, Richard Doerflinger, devoted his last column to the revolutionary development of induced pluripotent stem cells to which the President referred. As he noted, one of those who developed a process for reprogramming cells, Shinya Yamanka, was moved to develop this process once he recognized that there was no important difference between his daughters as embryos and as young children—they remain human beings at every stage of life. It is interesting that his home country, Japan, is apparently committed to expending considerable funds to develop this ethical stem cell alternative.(11)

Capitol Hill Briefings

Adult Stem Cell Research. One of the areas of promising ethical stem cell research to which the President alluded is, or rather continues to be, adult stem cell research.(12) Recent developments give hope to the aging (all of us), as well as to toddlers, and suggest we may one day be able to heal ourselves with stem cells from our own fat.(13)

On March 13, 2008, Do No Harm: The Coalition of Americans for Research Ethics and the Family Research Council organized a briefing in the U.S. Capitol on the therapeutic benefits being realized with adult stem cell treatments. Richard K. Burt, M.D., of Northwestern University’s Feinberg School of Medicine, was the main guest together with three patients he had successfully treated—Amy Daniels, Barry Goudy, and Jill Rosen. Dr. Burt discussed some of the latest successful adult stem cell treatments, including those for lupus/systemic lupus erythematosus, multiple sclerosis, new-onset diabetes, morphea, and systemic sclerosis. The patients then told their stories.

In October 2004, Amy Daniels was diagnosed with scleroderma, an autoimmune disease that affects connective tissue in the body and results in hardening of skins, lungs, and other organs. Her condition deteriorated severely. In March 2007, she was treated with adult stem cells, and she improved dramatically. She now leads a life free of symptoms. Barry Goudy was diagnosed with multiple sclerosis in May 1995. He was treated in July 2003 and was back at work two months later. He has been leading a symptom-free life for almost five years now. Jill Rosen was treated for antiphospholipid syndrome, a form of lupus, in March 2005. After a slow initial recovery, her conditions improved drastically in 2006, and her test results have been negative since.

At the event, the Patients First Act of 2007 (H.R. 2807) was briefly presented. The bill was introduced in Congress in June 2007 by Congressmen James Forbes (R-VA) and Dan Lipinsky (D-IL). It aims at “intensify[ing] stem cell research showing evidence of substantial clinical benefit to patients,”(14) provided such research does not create or destroy embryos.

Proponents of adult stem cell research have often been vilified in scientific journals, despite the evidence of many peer-reviewed studies that adult stem cells provide successful human treatments. On February 27, an article titled “Clinical Applications of Blood-Derived and Marrow-Derived Stem Cells for Nonmalignant Diseases” appeared in the prestigious Journal of the American Medical Association. It may finally begin to set the record straight.(15) The authors, including Dr. Burt, undertook a review of some of the literature on adult stem cell research. They focused on cardiovascular and auto-immune treatments, particularly those using stem cells derived from blood or bone marrow. The authors concluded, after reviewing treatments for approximately twenty-five hundred patients, that these adult stem cells have “disease-ameliorating effects in some autoimmune diseases and cardiovascular disorders.”

Embryo: A Defense of Human Life. This is the title of a new book by a member of the President’s Council on Bioethics, Prof. Robert P. George, and Christopher Tollefsen.(16) On February 25, Senator Tom Coburn of Oklahoma hosted a briefing on Capitol Hill by Prof. George. In the book and at the briefing, Prof. George offered a rigorously argued defense of the proposition that the embryo is a human being just like the rest of us, and, consequently, just like the rest of us, he deserves the protection of the law against those who would take his life.

Egg Donation and Cloning. As noted above, the President asked Congress to ban, inter alia, human cloning. Unfortunately, there is no significant movement in that direction in this Congress (nor will there be, I am certain, in the next).

Meanwhile, cloning news proliferates.

With primate cloning a fait accompli, it was only a matter of time before someone cloned a human being.(17) On January 17, 2008, the Stemagen Corporation of California announced that they had successfully cloned a human embryo.(18) The team of scientists created three embryos, all subsequently determined to be genetic matches with the male donor of the somatic cell used in the cloning process. (No stem cells were extracted.)(19)

Scientists at Newcastle University in England announced that they created an embryo with three parents.(20) The procedure involved removing the nucleus from an intact embryo and placing it in an enucleated oocyte in order to create a new embryo. The procedure is intended to prevent the transmission of mitochondrial disease.

It was reported in March that, in a procedure sometimes—and misleadingly—called “therapeutic cloning,” mice were cloned, stem cells were extracted from the embryos (thereby killing the embryos), and the mouse-embryonic stem cells were transplanted into the original diseased mice, whose conditions improved.(21) Although some mice did improve, it should be noted that the problems that have been long noted with embryonic stem cell research—tumor formation and chromosomal instability—were present here as well. (These problems exist with “embryonic-like” iPS cells also.) Furthermore, large numbers of mouse oocytes had to be used in order to obtain a few living embryos. Thus, cloning continues to be a very inefficient procedure.

A related problem is the difficulty of obtaining a sufficient number of oocytes to conduct the cloning trials. Those who support human cloning must overcome this obstacle. In England, despite obvious ethical problems including the exploitation of women, some IVF clinics offer an arrangement by which women undergoing IVF treatment receive a reduced rate in exchange for donating some of their oocytes.(22)
The human dimensions of this issue were addressed in a briefing on Capitol Hill on March 6. The Center for Bioethics and Culture Network sponsored the briefing in the U.S. Capitol on the risks associated with egg donation. The guest speakers were Ms. Jennifer Lahl, founder and national director of the Center for Bioethics and Culture Network, and Dr. Jennifer P. Schneider, a physician and an expert witness in court cases. In their talks, they pointed to the dangers to women’s health associated with egg donation. First, they focused on the immediate risks of ovarian stimulation, which is a part of the egg donation procedure. The prerecorded video testimony of Calla Papademas, a Stanford University student, was shown. In 2000, at the age of twenty-two, Papademas enrolled in the egg donation program, motivated by a desire to help infertile couples. After being accepted, she started self-administering Lupron (leuprolide acetate) hormone injections and instantly suffered agonizing migraine headaches, loss of vision, and nausea. In spite of this, her donation agency insisted on continuation of the procedure. Fortunately, she survived the ordeal but the result was a permanent brain damage and $100,000 in uninsured medical bills.(23) Her case confirms the well-known health risks of the procedure.

Next, they dealt with possible long-term health risks. Dr. Schneider told a story of her daughter Jessica Wing, who underwent ovarian stimulation for egg donation three times. Six years later Jessica died of colon cancer, at the age of thirty-one. The disease usually affects people over fifty. Jessica had no family history of the disease, and subsequent genetic studies showed that she had no genetic predisposition to colon cancer. Dr. Schneider is convinced that her daughter developed the cancer as a result of egg donation. She therefore asked for studies of long-term effects of egg donation on women’s health. Currently, very little is known of such risks because of the lack of data. Dr. Schneider proposed governmental creation of an egg donor registry. The registry would collect information about donors to allow for studies on the long-term effects on women’s health.(24)

State Developments

New Jersey

In November the people of New Jersey voted on Public Question 2, which authorized the New Jersey Stem Cell Research Bond Act, aimed at floating $450 million in bonds to fund the New Jersey Stem Cell Institute.(25) This followed more than three years of ever-expanding funding for embryo destructive research in New Jersey and the establishment of a legal regime that allows for research cloning.(26)
As a well-documented recent article in Nature explained, the NJ bond act galvanized significant opposition from fiscal and social conservatives.(27) As in Missouri, conservatives found the language of the public question to be deceptive, and New Jersey Right to Life took the matter to court. The New Jersey Superior Court, however, ruled against NJRTL on procedural grounds, which allowed the “loan and clone” question, as its opponents called it, to remain on the ballot.(28)

Nevertheless, on election day, Public Question 2 was defeated by 53 to 47 percent.(29) One factor that should not be underrated is the role of New Jersey’s Roman Catholic bishops. All five New Jersey bishops were active in efforts to oppose the initiative. On the Sunday before election day, all pastors were instructed to play a short informational video after Mass on the science and ethics of stem cell research. Learning about the issue doubtlessly persuaded many to vote against the bill. The bishops’ activities should be commended as a model of political involvement.(30)

Missouri

As I have reported in the past, Missouri is a fierce battleground in the fight over cloning. A referendum in 2006 narrowly passed that enshrined human embryo-destructive research-cloning in the state constitution while purporting to ban the procedure. It is reasonable to believe that the misleading language of the ballot initiative was a significant factor in its passage.

Since then, pro-life forces in Missouri, such as Cures Without Cloning, have been trying to pass their own referendum to enact a genuine ban on all human cloning.(31) However, Missouri Secretary of State Robin Carnahan decided to describe on the ballot the proposed cloning ban as follows: “Shall the Missouri Constitution be amended to repeal the current ban on human cloning or attempted cloning, and to limit Missouri patients’ access to stem cell research, therapies and cures approved by voters in November 2006…?” The impact of the initiative was described on the ballot as, “redefining the ban on human cloning or attempted human cloning to criminalize and impose civil penalties for some existing research, therapies and cures.” (32)

Missouri pro-lifers found this language seriously misleading and took the matter to court. On February 20, Cole County Circuit Judge Patricia Joyce ruled that the existing ballot language was “insufficient and unfair.”(33) She changed the description to say that the ban includes “prohibiting human cloning that is conducted by creating a human embryo at any stage from the one-cell stage forward; prohibiting expenditure of taxpayer dollars on research or experimentation on human cloning; and allowing stem cell research for therapies and cures that complies with these prohibitions and the prohibitions of Section 38(d) of the Constitution.”

The Missouri Secretary of State is planning to appeal. Thus, there may be a significant delay before proponents can begin collecting the required number of signatures to have the initiative placed on the ballot.(34)

Nebraska

Efforts have been underway in Nebraska for some time to restrict stem cell research and human cloning. While many pro-lifers wanted a Kansas-like blanket ban on cloning, in February a “compromise” bill, the Stem Cell Research Act (legislative bill 606),(35) was proposed. The act would ban “reproductive (or live-birth) cloning,” and no state funds or facilities could be used for embryo-destructive research (“research cloning”). However, up to $500,000 in matching funds would be provided by the state to those engaging in stem cell research that conformed to NIH funding guidelines, guidelines which could change dramatically after the upcoming presidential elections.(36) Thus, pro-life groups fought against the reproductive cloning ban vigorously, feeling that it amounted to a “clone and kill” provision, i.e., encouraging research cloning while banning only the birth of the cloned human being. Eventually, they got it stripped from the final version of the act.(37) The act places restrictions on state funds and facilities being used for the purposes of cloning, and defines a cloned embryo as a human embryo. But it is silent on the legality of cloning itself.(38) The Stem Cell Research Act passed in the Nebraska legislature 48 to 0 (with one abstention) on March 25, and is awaiting the governor’s signature.

Foreign Developments: Britain

There are two important developments to note, one relevant to the abortion debate and one to the embryonic debate.

First, the Royal College of Psychiatrists stated that women should not be allowed to have an abortion until they are counseled on the possible risk to their mental health.(39) This recognition of negative health effects from abortion is further evidence supporting the Supreme Court’s statements in last year’s partial-birth abortion ban case, Gonzales v. Carhart, that abortion harms women. Since the Court seemed to indicate that statutes providing for “full disclosure” would survive its scrutiny, this statement from the Royal College of Psychiatrists contributes to the possibility of future pro-life decisions by the Court.

Second, it is sad news, but it should be memorialized. More than one million human embryos created during IVF procedures in Britain have been destroyed. This occurred over the past fourteen years, as government records show.(40)