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Madame Chairman, please accept this written testimony
concerning the implications of S-1909/A2840 on the advent of safe,
effective, medically available treatments.
Due to a 1997 cervical spinal cord injury, I am among millions of
Americans whose hope for living a healthy, normal life lies in the
successful use of medical research resources. For the past five years I've
devoted my life entirely to understanding my medical condition, learning
key issues that Neuroscience believes stand in the way of its improvement,
and identifying clinicians and researchers whose work safely, efficiently,
and effectively addresses these concerns. I then contact and encourage
these researchers to communicate, cooperate, and collaborate towards
bringing promising medical research from the bench to the bedside.
Based on solid, peer-reviewed animal studies, the results of human
clinical trials, and factual comments by leading scientists, my actions
and viewpoints are formed purely with the practical development of medical
research for the sake of cures in mind. I do not
promote research for the sake of scientific, commercial, religious, or
political interests.
Quite literally, the issues addressed by the bills in question stand to
mean the difference between life or death for tens of millions of
Americans, while millions more face life-long impairment should valuable
resources be misspent on avenues that offer little practical potentials.
In my opinion, clear, black and white evidence exists that points to the
safest, most logical, most expedient means of addressing the dire medical
concerns that stem cells are hoped to cure. This evidence is so clear and
so well-grounded, and the human stakes so high, that no moral
justification can exist for New Jersey to weigh economic, political, or
institutional concerns in choosing its "Biotech and Stem Cell" course.
Certainly not when the saving of lives conflicts with mundane motives.
Therefore, in choosing its Biotech and stem cell course, I respectfully
ask the New Jersey State Assembly to consider the following perspectives
as though all whose fate lies with Medical Science is a beloved friend or
family member.
The Bills in question makes specific statements that suggest:
- All stem cell research, including adult stem cells, is
mired by ethical concerns.1
- human embryonic stem cells, adult stem cells, and stem cells derived
from cloning (somatic nuclear transfer) offer the "promise" of curing
these conditions.2
- the goal of these bills is to cure 128 Million Americans of chronic
disease and crippling conditions by supporting the Biotech Industry and
Biomedical Research [2].3
- New Jersey will economically prosper through this support.4
- New Jersey will "give full consideration" to ethical aspects of the
issues in question.5
The following testimony examines the validity of these contentions.
All stem cell research, including adult stem cells, is mired by ethical
concerns (excerpt from S-1909).
All stem cell research is not plagued by ethical or moral opposition.
Research involving embryonic and fetal stem cells raise fervent moral
objections by those opposed to consigning any form of human life to
serving commercial, personal, political, or institutional interests. But
adult stem cell use, either for research or clinical uses, raise neither
"ethical or public policy concerns." Therefore, in weighing the ethics of
embryonic and fetal stem cell research (whether derived from cloning or
not) against potential medical benefits[5], it should be noted the
non-support of morally objectionable embryonic and fetal stem cell
research does not preclude the advent of stem cell cures. Indeed, advances
in adult stem cell research and clinical results provides clear, rational
evidence that the clinical goals these bills seek to attain would best be
served by New Jersey focusing its stem cell support on adult stem
cell research, the safe, effective, less-problematic, and
non-controversial means to this end.
Human embryonic stem cells, adult stem cells, and stem cells
derived from cloning (somatic nuclear transfer) offer the "promise" of
curing these conditions (excerpt from S-1909).
Embryonic Stem Cells (ESCs):
All stem cells are not created equal. Embryonic stem cells are designed
to multiply and mature in embryos. In adult tissues they mutate into
tumors, mature into inappropriate tissues, such as hair, bone, and teeth
when implanted directly in the brain., and are genetically unstable.
Regarding these points, Dr. Gail Martin, a mouse embryonic stem cell
researcher at the University of California explained to the New York Times
that when growing ESCs in the lab, she said, some of them spontaneously
change, with chunks of genetic material moving from place to place on
chromosomes. She said that when such changes gave cells even a 5 percent
growth advantage in the laboratory, the altered cells completely took over
the stem cell population within three generations. And if such cells were
put into patients, they could cause cancer.6
Regarding the "promise" of ESC research, the
above-cited article refers to the ungrounded hype:
"I even hear from patients whose fathers have lung cancer," said Dr.
Hogan, a professor at Vanderbilt University School of Medicine. "They
have a whole slew of problems they think can be treated. They think stem
cells are going to cure their loved ones of everything."
then bluntly admits the cold, hard truth:
"If it ever happens, it will not happen soon, scientists say. In
fact, although they worked with mouse embryonic stem cells for 20 years
and made some progress, researchers have not yet used these cells to
cure a single mouse of a disease." and...
"Scientists say the theory behind stem cells is correct: the cells,
in principle, can become any specialized cell of the body. But between
theory and therapy lie a host of research obstacles. Though not often
discussed in public forums, the obstacles are so serious that scientists
say they foresee years, if not decades, of concerted work on basic
science before they can even think of trying to treat a patient."
Most disturbing, to my mind, is the fact most researchers now agree
that ESCs are not desirable for direct transplantation, that cells further
developed towards their final fate are widely accepted as the safest, most
controllable means to replace diseased or damaged cells. Regarding this
point, Dr. Wise Young, Director of Rutgers Center for Collaborative
Neuroscience admitted in his online forum there is now "a growing
consensus in the field that the most desirable cells for transplantation
are cells that are far enough along the way to differentiating into
desirable cells, such as neurons, insulin-secreting cells, radial glial or
olfactory ensheathing glial cells, that they have a high likelihood of
producing such cells. I recently heard a lecture by John Gearhart
expressing the same goal, the differentiation of fetal stem cells to the
point where they will produce a particular cell type predictably." (In
fact, Dr. Young also admitted that "adult autografts are looming in the
next few years and would be the preferred source of cells." Care/Cure.com
1/1/02)
However, it is far from clear that fetal stem cells are any safer to
use for adult applications than ESCs. In fact, clinical results of fetal
trials for Parkinson's Disease suggest they're not.7
Yes, the implanted fetal cells resulted in more dopamine production, too
much in fact. Already afflicted by a crippling disease, some of the
patient's conditions were irreversibly worsened. Younger patients showed
"measurable" improvement, while older patients (which the authors admit
make up "the typical age range of individuals afflicted with PD") showed
no improvement at all. The trial's report conclude:
"These problems must be solved before fetal tissue transplantation
can be considered a therapeutic option for PD."
Contrast this to the adult neural stem cell success in a severely
afflicted 57-year-old man as reported by Medscape's Dr. Laurie
Barclay (and reviewed by Dr. Gary Vogin):
"At 3 months after transplantation, the patient's motor scores on his
usual medications improved by 37% on blinded neurologic examination, and
fluoro-DOPA PET studies showed a 55.6% increase in dopamine uptake. At 1
year posttransplantation, his Unified Parkinson's Disease Rating Scale (UPDRS)
improved by 81% while on medication and 83% while off medication."8
Nor is adult stem cell clinical successes by any means limited to
Parkinson's Disease. Adult stem cells or their derivatives have been
safely and effectively used in human trials for Sickle Cell, Multiple
Sclerosis, Stroke, Traumatic Brain Injury, Leukemia, Heart Disease,
Arthritis, and more9
And animal research suggests more adult stem cell
successes are on the way.10
Whereas ESCs have cured absolutely nothing despite over twenty
years of intensive basic research. Therefore, in citing the previously
mentioned heart disease clinical results, the Director of the
German Medical Journal Deutsche Medizinische
Wochenschrift points out:
"The promises of unscrupulous embryo researchers, that clone without
clear clinical goals and experiments, are insupportable. This remarkable
proof has now given us a clear sign the Americans with their
prohibitions are exactly right. The biotechnological revolution can take
place without embryonic stem cells if the alternatives are developed."
Yet, the New Jersey Senate would have its sick and disabled citizens
believe it's in their interests for valuable public and non-profit funds
to be used to possibly overcome mammoth safety and basic research hurdles
inherent in ESCsonly to bring them to fetal stages also beset by
daunting safety hurdles. Meanwhile, clinical results (including the above
Parkinson's study and fetal trials for SCI at the University of Florida in
Gainesville) indicate that fetal transplants are only mildly
effective at best. So as one whose only interest is the advent of
cures, I can't help asking, "What's the point?"
The answer wasn't hard to find.
The Institute of Science in Society (ISIS), an international
organization of 462 scientists from 57 countries whose avowed concern is
that Science is ethically and efficiently used to serve mankind's needs,
issued the statement:
"The risks of cancer, uncontrollable growth, genome instability and
other hurdles make ES cells a bad investment in terms of finance as well
as health benefits." They further add that adult stem cells "are more
likely to generate affordable therapies that can benefit everyone." But
they explain the ES hype: "Commercial imperatives are the major impetus
for ES cell research, much more so than for adult stem cells research.
There are more opportunities for patenting cells and cell lines as well
as isolation procedures."
In my opinion their summary cuts to the quick:
"Scientists should stop manipulating public opinion to promote
research that's both morally and scientifically indefensible. At the
same time, governments need to invest our tax money in scientific
research that can genuinely benefit the health of the nation, and not be
misled by false promises of the next economic boom."
Regarding therapeutic cloning (somatic nuclear transfer)
Cloning is being promoted primarily for two applications: 1) to produce
genetically matched embryonic stem cells (or their derivatives) for
transplantation purposes; 2) to study cells derived from cloning for
genetic defects involved in inherited disease. Regarding direct
"therapeutic" applications, cloning is hoped to create genetically matched
cells able to avoid immune rejection. However, in a recent study, an adult
mouse twice rejected its own cloned embryonic stem cells.11
In reporting this finding, M.I.T. researcher Rudolf Jaenisch says:
"Our results raise the provocative possibility that even genetically
matched cells derived by therapeutic cloning may still face barriers to
effective transplantation for some disorders."
Comments made by leading pro-cloning scientists reveal the previous
results weren't wholly unexpected. In speaking to the President's Council
on Bioethics, Dr. John Gearhart of John Hopkins said there was "no
question" in his mind that embryonic stem cells derived from cloning
"could be rejected. Absolutely."
Dr. Irving Weissman of Stanford went a step further by telling the
council:
"I should say that when you put the nucleus in from a somatic cell,
the mitochondria still come from the host (the egg)." He concluded, "And
in mouse studies it is clear that those genetic differences can lead to
a mild but certainly effective transplant rejection and so
immunosuppression, mild though it is, will be required for that."
It is important to note that fetal cells have been used in human
clinical trials without rejection. (The central nervous system is
considered immune privileged.) It's also true the studies cited above led
to inconclusive and even negative results. Yet their failure had
nothing to do with rejection. Therefore, despite Drs. Gearhart and
Weissman's admission that cells derived from cloning do not perfectly
match the donor, the fact is that cells derived from cloning may indeed
not be rejected for certain applications (as the Chinese and
A.C.T.'s Dr. Lanza have recently claimed). However, from a pro-cures
perspective, the key question is not what cells derived from cloning may
or may not be able to do, but rather what are they undeniably, inescapably
known to do.
The technical issue that lies at the heart of cloning involves its
inherent genetic "imprinting errors.12"
Simply put, creating embryos without both male and female genetic
contributions leads to widespread, unpredictable genetic flaws in the
permanent genetic code of every resulting cell, be it embryonic,
fetal, or adult. In cloned animals these defects lead to high rates of
fetal death, birth defects, stunted development, premature aging, disease,
deformity, and early death. Comments by leading scientists in the cloning
field bring home the sobering import of this crucial point:
- MIT's Rudolf Jaenish says, "I have argued before, in Congress and
other occasions, this is unsafe and will remain so for the foreseeable
future. I believe there actually are principal biological barriers to
make it ever really safe.13
- "All of the data on animal cloning demonstrates exceptionally high
rates of fetal loss, abortion (and) neonatal deaths, and many cloned
animals have devastating birth defects," says Gerald Schatten, vice
chairman of obstetrics, gynecology and reproductive science at the
University of Pittsburgh School of Medicine.14
- Of particular concern are embryos that appear healthy but at the
genetic level are a "gallery of horrors," says Tanja Dominko, who
conducted primate-cloning research at the Oregon Regional Primate
Research Center in Beaverton[30].
- Many of the birth defects observed in cloned animals are similar to
the gross physical deformities and mental retardation found in rare
genetic disorders caused by a phenomenon known as genetic imprinting,
says Arthur Beaudet, professor of genetics at Baylor College of
Medicine[30].
- The prevalence of genetic disorders in cloned animals and the lack
of knowledge about reprogramming are the primary reasons the scientists
who work on cloning and issues of reprogramming say they are skeptical
that anyone can clone a human without genetic errors, Beaudet and others
say[30].
- Says University of Pennsylvania Researcher Hans Schöler, "Our
embryos can look very nice. But they are ticking time bombs."15
- Regarding genetic imprinting problems inherent in cloning, the
creator of Dolly the Sheep, Ian Wilmut, said in the peer-reviewed
journal Nature: "It should keep a lot of
us in business for a long time." 16
Which leads to three questions regarding the actual "promise" of
therapeutic cloning:
- How can cells known to contain widespread, unpredictable genetic
flaws possibly be medically used with any degree of certainty regarding
short- and long-term safety and performance?
- How can such cells provide reliable material for genetic
testing?
- How can the authors of the S-1909 possibly claim this
legislation is fueled by anything other than the desire to support
special interests in New Jersey's research and Biotech sectors, and
their own political careers? (It certainly isn't in the
interest of cures!)
"The biomedical industry is a critical and growing component of New
Jersey's economy, and would be significantly diminished by limitations
imposed on stem cell research; (excerpt from S-1909)"
This viewpoint begs two questions:
- Will New Jersey's economy be better served by curing her sick and
disabled, thus returning thousands of skilled, productive wage earners
to the workplace, or by allowing its sick and disabled to die or remain
indefinitely disabled for the financial sake of academic researchers and
Biotech?
- Which of the two is the moral course?
"The public policy of this State governing stem cell research must:
balance ethical and medical considerations, based upon both an
understanding of the science associated with stem cell research and a
thorough consideration of the ethical concerns regarding this research;
and be carefully crafted to ensure that researchers have the tools
necessary to fulfill the promise of this research."
Where is the "full consideration for the ethical and medical
implications" that New Jersey claims to seek? S-1909 clearly states its
author's intention to embark on a course of "publicly funded stem cell
research" supporting ESCs and cloning regardless of actual therapeutic
potentials, and totally dismissing stark moral issues abhorrent to so many.17
As used in this section, "cloning of a human being" means the
replication of a human individual by cultivating a cell with genetic
material through the egg, embryo, fetal and newborn stages into a new
human individual (excerpt from S-1909)
Also, a year ago Christopher Reeve told the U.S. Senate that a
"slippery moral slope" was not an issue in the cloning debate. Mr. Reeve
(and most pro-cloning scientists) claimed that all they wanted was access
to 14-day-old "blastocysts," which Mr. Reeve claims doesn't "deserve" the
title of embryo. Now New Jersey seeks the killing of babies while leading
its sick and disabled down a primrose pathall for political, commercial,
and institutional gain.
For the sake of the truth, for the People of New Jersey, and
ultimately, for the sake of your own humanity, please vote "No!" to
S-1909/A2840.
1
NJ S-1909: "Stem cell research, including the use of embryonic stem cells
for medical research, raises significant ethical and public policy
concerns; and, although not unique, the ethical and policy concerns
associated with stem cell research must be carefully considered."
2 NJ S-1909: "Open scientific
inquiry and publicly funded research will be essential to realizing the
promise of stem cell research and maintaining this State's leadership in
biomedicine and biotechnology. Publicly funded stem cell research,
conducted under established standards of open scientific exchange, peer
review and public oversight, offers the most efficient and responsible
means of fulfilling the promise of stem cells to provide regenerative
medical therapies."
3 NJ S-1909: "An estimated
128 million Americans suffer from the crippling economic and psychological
burden of chronic, degenerative and acute diseases, including Alzheimer's
disease, cancer, diabetes and Parkinson's disease."
4 NJ S-1909: "The biomedical
industry is a critical and growing component of New Jersey's economy, and
would be significantly diminished by limitations imposed on stem cell
research."
5 NJ S-1909: "The public
policy of this State governing stem cell research must: balance ethical
and medical considerations, based upon both an understanding of the
science associated with stem cell research and a thorough consideration of
the ethical concerns regarding this research; and be carefully crafted to
ensure that researchers have the tools necessary to fulfill the promise of
this research."
6 By Gina Kolata, A Thick Line
Between Theory and Therapy, as Shown With Mice, New York Times,
December 18, 2001.
7 Paul E. Greene, M.D.,
Stanley Fahn,
M.D., Status of Fetal Tissue Transplantation for the Treatment of Advanced
Parkinson Disease, Neurosurgical Focus, 01/07/2003.
8 Laurie Barclay, MD, Gary D. Vogin,
MD, Autologous Neural Stem Cells Improve PD Symptoms, MedscapeWire,
April 2002.
9 Ouyang J, Ni X, Chen B. [A
preliminary result of treatment of progressive multiple sclerosis with
autologous peripheral blood stem cell transplantation in China]
Zhonghua Nei Ke Za Zhi 2001 Aug;40(8):550-2; By Merritt McKinney, Stem cells
may slow severe MS, Reuters Health 16-Apr-02; Hacein-Bey-Abina S, Sustained
correction of X-linked severe combined immunodeficiency by ex vivo gene
therapy. N Engl J Med 2002 Apr 18;346(16):1185-93;
12 Strauer BE, Brehm M, Zeus T,
Gattermann N, Hernandez A, Sorg RV, Kogler G, Wernet P. [Intracoronary,
human autologous stem cell transplantation for myocardial regeneration
following myocardial infarction] Dtsch Med Wochenschr 2001 Aug
24;126(34-35):932-8; Horwitz EM, Transplantability and
therapeutic effects of bone marrow-derived mesenchymal cells in children
with osteogenesis imperfecta. Nat Med 1999 Mar;5; Schwab IR, Reyes M, Isseroff RR.
Successful transplantation of bioengineered tissue replacements in
patients with ocular surface disease. Cornea 2000
Jul;19(4):421-6; 60 Minutes II: Holy Grail, Keone Penn was cured by a stem
cell treatment. Nov. 28, 2001; James Meek, science
correspondent, Baby cord cells offer leukaemia breakthrough, The
Guardian, Tuesday July 9, 2002; Wulffraat NM, Prolonged remission
without treatment after autologous stem cell transplantation for
refractory childhood systemic lupus erythematosus. Arthritis Rheum
2001 Mar;44(3):728-31; Kondziolka D, Transplantation of
cultured human neuronal cells for patients with stroke. Neurology
2000 Aug 22;55(4):565-9.
10 By William J. Cromie,
Adult stem cells effect a cure, Harvard Gazette Staff (in vivo animal
research); Ramiya VK; Maraist M; Arfors KE;
Schatz DA; Peck AB; Cornelius JG, Reversal of insulin-dependent diabetes
using islets generated in-vitro from pancreatic stem cells. Nat Med
2000 Mar;6(3):278-82 (in vivo animal research); Ramon-Cueto A, Cordero MI,
Santos-Benito FF and Avila J (2000). Functional recovery of paraplegic
rats and motor axon regeneration in their spinal cords by olfactory
ensheathing glia. Neuron. 25 (2): 425-35; Imaizumi T, Lankford KL and
Kocsis JD (2000). Transplantation of olfactory ensheathing cells or
Schwann cells retores rapid and secure conduction across the transected
spinal cord. Brain Res. 854 (1-2): 70-8; Lu J; Feron F; Mackay-Sim A;
Waite PM. Olfactory ensheathing cells promote locomotor recovery after
delayed transplantation into transected spinal cord. Brain 2002
Jan; Hofstetter CP; Schwarz EJ; Hess
D; Widenfalk J; El Manira A; Prockop DJ; Olson L, Marrow stromal cells
form guiding strands in the injured spinal cord and promote recovery.
Proc Natl Acad Sci USA 2002 Feb 19;99(4):2199-204.
11 William M. Rideout III, Konrad
Hochedlinger, Michael Kyba, George Q. Daley, and Rudolf Jaenisch,
Correction of a genetic defect by nuclear transplantation and combined
cell and gene therapy. Cell, vol. 109 no. 1, pp. 17-27.
12 Rideout WM; Eggan K; Jaenisch R.
Nuclear cloning and epigenetic reprogramming of the genome. Science
2001 Aug 10;293; Humpherys D; et. al,. Epigenetic
instability in ES cells and cloned mice. Science, July 2001; Hochedlinger K; et. al., Abnormal
gene expression in cloned mice derived from embryonic stem cell and
cumulus cell nuclei. Proc Natl Acad Sci USA 2002 Oct 1.
13 Rudolf Jaenish, Cloning: the
Debate, New York Acadmeny of Sciences, May 20, 2002.
14 Seeing double: Hype
over cloning obscures its dangers, by Tim Friend, Seattle Times,
2003
15 Hans Schöler. Single gene failure
explains cloning deaths. New Scientist, 14 May 2002, reference to Boiani,
Eckardt, Schöler, and McLaughlin, Oct 4 level and distribution in mouse
clones: consequences for pluripotency. Genes and Development, May
15th 2002.
16 Ian Wilmut, Cause of Sick Clones
Contested, Nature, 11 January 2002.
17 NJ S-1909: It is the
public policy of this State that research involving the derivation and use
of human embryonic stem cells, human embryonic germ cells, and human adult
stem cells (from any source) including somatic cell nuclear
transplantation, shall: (1) be permitted in this State; (2) be conducted
with full consideration for the ethical and medical implications of this
research.
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