May 24, 2005 | WebMemo on Health Care
We are in the midst of a major national debate on stem cell research. There are a variety of ethical and religious views on this issue, and these perspectives are important. But there are also practical and scientific issues. The Heritage Foundation recently hosted a panel discussion to raise and discuss these issues. This paper presents excerpts from the remarks of three speakers at that event. All three have expertise in the subject and regularly address the public policy questions involved in stem cell research. Kelly Hollowell, Ph.D., is a molecular and cellular pharmacologist and a patent attorney. Phil Coelho is CEO and Chairman of the Board of Thermogenesis Corp., which provides cord blood stem cell processing and cryopreservation systems used by major cord blood stem cell banks. And Representative Dave Weldon is a physician and represents the 15th Congressional District of Florida.
--Robert Moffit, Ph.D.
Kelly Hollowell, Ph.D.: Embryonic stem cells are the unspecialized cells that form the basic building blocks for all of the specialized cell types in the body. Researchers hope to treat human diseases by using stem cells taken from embryos. The primary sources for embryonic stem cells are aborted fetuses and the donated and unused embryos housed in in vitro fertilization (IVF) facilities. To obtain embryonic stem cells, an embryo is formed and allowed to mature for five to seven days. The inner mass of the stem cells is then removed, plated, and treated with chemicals to become specialized cell types. In theory, these specialized cells will be used to treat dead, diseased, or dying tissue.
In the process of harvesting embryonic stem cells, the embryo is destroyed. The primary ethical question raised is whether embryos are People or property. A second ethical issue lies in the extreme inefficiency of harvesting embryonic stem cells. Specifically, the process requires women's eggs. To treat, for example, the 17 million diabetes patients in the United States will require a minimum of 850 million to 1.7 billion human eggs. Collecting 10 eggs per donor will require a minimum of 85 to 170 million women. The total cost would be astronomical, at $100,000 to $200,000 for 50 to 100 human eggs per each patient.
Even more important than the dollars and the difficulty is that the process of harvesting a woman's eggs for stem cells places that woman at risk. Superovulation regimens for fertility treatments would be used to obtain women's eggs. The risks associated with superovulation regimens or high-dose hormone therapies are debated. But there is a growing body of evidence showing that these practices, when used for standard IVF, can cause a wide spectrum of problems including memory loss, seizure, stroke, infertility, cancer, and even death. This points to yet another ethical issue: the future commercial exploitation of women, and particularly poor women, to collect their eggs.
No currently approved treatments have been obtained using embryonic stem cells. There are no human trials-despite all the hype and all the media. After 20 years of research, embryonic stem cells haven't been used to treat People because the cells are unproven and unsafe. They tend to produce tumors, cause transplant rejection, and form the wrong kinds of cells.
Private investors aren't funding embryonic stem cell research. They are funding adult stem cell research, which is an ethical alternative. Some of the most startling advancements using adult stem cells have come in treating Parkinson's disease, juvenile diabetes, and spinal cord injuries.
The scientific data on embryonic stem cell research simply does not support continued investment in research. Even if the research were successful, it is morally bankrupt and endangers women. Federal funding should not be used to pay for research that many Americans know is morally wrong and scientifically unsound. That makes embryonic stem cell research a bad investment for our tax dollars.
Philip H. Coelho: Let's take a look at three sources of stem cells: embryonic stem cells, adult bone marrow stem cells, and neo-natal cord blood stem cells. Embryonic stem cells have theoretical advantages: they can become all the different tissues of the body and they have a whole life's worth of cell divisions available to them. But they have also triggered malignant carcinomas in animals, and so researchers are cautious about expecting any clinical trials using embryonic stem cells in the near term.
Adult stem cells are typically drawn from the bone marrow of patients. They also have advantages and have been used clinically about 30,000 times. They do have some disadvantages, however: there are risks to the donor during extraction; there is significant risk of transmission of infectious disease from donor to recipient; and the cells have the potential for fewer divisions.
The Use of Cord Blood
My company has focused on neo-natal cord blood stem cells because they have some dramatic advantages: they can become several-and perhaps all-the different tissue types; they involve no donor risks; they have the capacity for many cell divisions; and they cause less graft versus host disease, in which the donor cells attack the tissue of the patient's body, than adult bone marrow stem cells.
The first patient to be treated with cord blood stem cells in 1988 today shows no evidence of the Fanconi Anemia that he suffered from as a child. On the basis of that success, Dr. Pablo Rubinstein, Director of the National Cord Blood Program at the New York Blood Center, and Dr. Joanne Kurtzberg, Director of the Pediatric Bone Marrow and Stem Cell Transplant Program at Duke University Medical Center, launched cord blood transplant medicine.
So far, more than 6,000 patients and 66 diseases have been successfully treated with stem cells from cord blood.The clinical advantages of cord blood are promising. A recent study found a survival rate of around 70 percent among high-risk adults treated with cord blood. Results are even more promising with children, with clinical trials showing an 80 percent survival rate for children with immunodeficiency diseases. An article in the New England Journal of Medicine last year showed a 90 percent success rate in treating a disease called Hurler syndrome that affects the brain. And for the first time, not only was cord blood arresting the disease, Dr. Kurtzberg noted, but it was beginning to reverse the symptoms.
Congressman Weldon: Adult stem cells and, in particular, cord blood stem cells are going to be the sources for the regenerative, miraculous medicine in the future. Embryonic stem cell research is just not getting good research results.
Now, from a policy perspective: Congress spoke to this issue several years ago when Congressman Roger Wicker (R-MS) and then-Congressman Jay Dickey (R-AR) authored language that said that no NIH funds can be used for any research involving the destruction of a human embryo. President Bill Clinton signed that bill and then, shortly after that, came up with a way to get around the so-called Dickey/Wicker language simply by allowing outside researchers to destroy embryos and then move the stem cells over to NIH.
The Bush Policy
That was what George Bush inherited. His solution, I thought, was rather eloquent: he allowed ongoing funding for research on the stem cell lines that had been accumulated because the embryos were destroyed, but no more additional funding would be provided for the destruction of embryos.
That is basically the debate we have this year. Rep. Castle (R-DE) and Rep. DeGette (D-CO) have introduced a bill in the House to partially override the President's position and allow NIH dollars to be used on the so-called "excess embryos" from fertility clinics. A Rand study found that the vast majority of those 400,000 embryos are wanted. The parents are holding on to them because they want to do another cycle and possibly have another baby. Many of the parents are not comfortable with donating their embryos for destructive research. The other thing that's very interesting is, when you thaw these embryos, there's a very high mortality rate. They've been in the freezer for a long time, and a lot of them die. It's estimated that you would only get about 250 to 300 cell lines if the Castle bill were to become law.
There are millions of Americans who do not want to fund destructive embryonic research for the same reason they don't want to fund abortions. I think our prohibition on federal funding is the proper way for us to go, since we have a divergence of opinion in the population. There is no prohibition on private funding. The state of California has moved forward on its own. I think its taxpayers, in time, will regret that decision when they see no good cures coming out of it. But the President's policy is the right policy. The Dickey/Wicker language is the right thing for us to have in law.
I want to read to you a fascinating quote from William Haseltine, CEO of Human Genome Sciences, Inc., of Rockville, Maryland. He is a leading advocate for embryonic stem cells, but here's the interesting thing he said: "The routine utilization of human embryonic stem cells for medicine is 20 to 30 years hence. The timeline to commercialization is so long that I simply would not invest. You may notice that our company has not made such investments." And what's going on in California with the taxpayers funding embryonic stem cell research is that the taxpayers are funding what the venture capitalists will not fund. And that's exactly what's going on in this city: People are trying to get the federal taxpayers to fund what the venture capitalists will not fund.
Robert Moffit, Ph.D.,is Director of Health Policy Studies at The Heritage Foundation. Kelly Hollowell, Ph.D., is a molecular and cellular pharmacologist and a patent attorney. Phil Coelho is CEO and Chairman of the Board of Thermogenesis Corp. The Honorable Dave Weldon is a United States Representative from Florida. Their remarks were made at The Heritage Foundation event "Stem Cell Research: What Taxpayers Must Know," held on May 10, 2005, in Washington, D.C.