Written Testimony by James Kelly to the New Jersey State Assembly
Patient Advocate for Spinal Cord Injury Research

James Kelly
February 3rd, 2003
Reproduced with Permission

To: The New Jersey State Assembly

On: Stem Cell Research and Biotech

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 cancer6.

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 not7. 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 Vogin8)

"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 more9101112131415161718. And animal research suggests more adult stem cell successes are on the way192021222324. 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 cells25. 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 errors262728." 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:

  1. 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?
  2. How can such cells provide reliable material for genetic testing?
  3. 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:

  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 many33.

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.

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." [Back]

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." [Back]

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." [Back]

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." [Back]

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." [Back]

6 By Gina Kolata, A Thick Line Between Theory and Therapy, as Shown With Mice, New York Times, December 18, 2001. [Back]

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. [Back]

8 Laurie Barclay, MD, Gary D. Vogin, MD, Autologous Neural Stem Cells Improve PD Symptoms, MedscapeWire, April 2002. [Back]

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. [Back]

10 By Merritt McKinney, Stem cells may slow severe MS, Reuters Health 16-Apr-02. [Back]

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. [Back]

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. [Back]

13 Horwitz EM, Transplantability and therapeutic effects of bone marrow-derived mesenchymal cells in children with osteogenesis imperfecta. Nat Med 1999 Mar;5. [Back]

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. [Back]

15 60 Minutes II: Holy Grail, Keone Penn was cured by a stem cell treatment. Nov. 28, 2001. [Back]

16 James Meek, science correspondent, Baby cord cells offer leukaemia breakthrough, The Guardian, Tuesday July 9, 2002. [Back]

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. [Back]

18 Kondziolka D, Transplantation of cultured human neuronal cells for patients with stroke. Neurology 2000 Aug 22;55(4):565-9. [Back]

19 By William J. Cromie, Adult stem cells effect a cure, Harvard Gazette Staff (in vivo animal research). [Back]

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). [Back]

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. [Back]

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. [Back]

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. [Back]

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 USA 2002 Feb 19;99(4):2199-204. [Back]

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. [Back]

26 Rideout WM; Eggan K; Jaenisch R. Nuclear cloning and epigenetic reprogramming of the genome. Science 2001 Aug 10;293. [Back]

27 Humpherys D; et. al,. Epigenetic instability in ES cells and cloned mice. Science, July 2001. [Back]

28 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. [Back]

29 Rudolf Jaenish, Cloning: the Debate, New York Acadmeny of Sciences, May 20, 2002. [Back]

30 Seeing double: Hype over cloning obscures its dangers, by Tim Friend, Seattle Times, 2003. [Back]

31 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. [Back]

32 Ian Wilmut, Cause of Sick Clones Contested, Nature, 11 January 2002. [Back]

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. [Back]

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