Introduction
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.
Ethical Issues
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.
Practical Results
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.
Good Results
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.
Taxpayer Burdens
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.