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CONGRESSIONAL TESTIMONY |
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Testimony Before The New Jersey State Assembly on Stem Cell Research and
Biotech
Statement by James Kelly |
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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:
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, 8) “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.” Presently,
three years after being treated with his own cultured neural stem cells,
according to the neurosurgeon involved (Dr. Michael Levesque,
Neurosurgical Director of Cedars Sinai Medical Center) the patient remains
without visible Parkinsonian symptoms, causing Levesque to conclude: "This form of treatment has the potential for making neural stem cell therapy acceptable and available to a large number of patients." 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 more (9,10,11,12,13,14,15,16,17,18). And animal research suggests more adult stem cell successes are on the way (19,20,21,22,23,24). 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 ESCs…only 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 (25). 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
(26,27,28).” 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:
Which leads to three questions regarding the actual "promise" of
therapeutic cloning:
“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: 1.
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? 2.
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 (33). 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 (34).(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 path…all 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. References: 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 10. By Merritt
McKinney, Stem cells may slow severe MS, Reuters Health
16-Apr-02 11. 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 13. Horwitz EM,
Transplantability and therapeutic effects of bone marrow-derived
mesenchymal cells in children with osteogenesis imperfecta. Nat Med
1999 Mar;5 14. 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 15. 60 Minutes
II: Holy Grail, Keone Penn was cured by a stem cell treatment.Nov.
28, 2001 16. James Meek,
science correspondent, Baby cord cells offer leukaemia breakthrough, The
Guardian, Tuesday July 9, 2002 17. 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 18. Kondziolka D,
Transplantation of cultured human neuronal cells for patients with stroke.
Neurology 2000 Aug 22;55(4):565-9 19. By William J.
Cromie, Adult stem cells effect a cure, Harvard Gazette Staff (in
vivo animal research) 20. 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) 21. 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. 22. Imaizumi T,
Lankford KL and Kocsis JD (2000). Transplantation of olfactory ensheathing
cells or Schwann cells restores rapid and secure conduction across the
transected spinal cord. Brain Res. 854 (1-2): 70-8. 23. 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 24. 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 U S A 2002 Feb
19;99(4):2199-204 25. 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 26. Rideout WM;
Eggan K; Jaenisch R. Nuclear cloning and epigenetic reprogramming of the
genome. Science 2001 Aug 10;293 27. Humpherys D;
et. al,. Epigenetic instability in ES cells and cloned mice. Science,
July 2001 28. Hochedlinger
K; et. al., Abnormal gene expression in cloned mice derived from embryonic
stem cell and cumulus cell nuclei. Proc Natl Acad Sci U S A 2002
Oct 1 29. Rudolf
Jaenish, Cloning: the Debate, New York Acadmeny of Sciences, May 20, 2002 30. Seeing
double: Hype over cloning obscures its dangers, by Tim Friend, Seattle
Times, 2003 31. Hans Schöler. Single
gene failure explains cloning deaths. New Scientist, 14 May 2002,
reference to Boiani, Eckardt, Schöler,
and McLaughlin, Oct4 level and distribution in mouse
clones: consequences for pluripotency. Genes and Development, May
15th 2002 32.
Ian Wilmut, Cause of Sick Clones Contested, Nature, 11
January 2002 33. 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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