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Prop 71: Stem Cell Hype and Hope

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... held for family building (i.e., babies) 2.2% are slated to be discarded ... Schwartz, R. E. ... Northwestern University: Testimony before the US Senate 9/29/2004 ... – PowerPoint PPT presentation

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Title: Prop 71: Stem Cell Hype and Hope


1
Prop 71 Stem Cell Hype and Hope
  • Richard Deem,Scientists Against Proposition 71
    (www.NoOn71.us)

2
Topics
  • What are stem cells
  • Stem cell types
  • Human cloning
  • Whats wrong with Proposition 71
  • Problems
  • Deceptive Claims
  • Cures or hype?
  • ESC/cloning problems
  • Ethical questions

3
Stem Cell Definition
  • A cell that has the ability to continuously
    divide and differentiate (develop) into various
    other kind(s) of cells/tissues

4
Kinds of Stem Cells
Totipotent
Pluripotent
Multipotent
5
Sources of Stem Cells
Embryonic
Fetal stem cells
Umbilical cordstem cells
Placenta derivedstem cells
Adult stem cells
6
Stages of Embryogenesis
7
Derivation and Use of Embryonic Stem Cell Lines
8
History of Somatic Cell Nuclear Transfer (Cloning)
  • 1996 Dolly, the sheep cloned
  • 1998 Mice cloned
  • 1998 Cows cloned
  • 2000 Pigs cloned
  • 2001 Cat cloned
  • 2002 Rabbits cloned
  • 2003 Mule cloned
  • 2004 Bull serial-cloned

9
Human Embryo Cloning
  • 2001 First cloned human embryos (only to six
    cell stage) created by Advanced Cell Technology
    (USA)
  • 2004 First human cloned blastocyst created and
    a cell line established (Korea)

Hwang, W.S., et al. 2004. Evidence of a
Pluripotent Human Embryonic Stem Cell Line
Derived from a Cloned Blastocyst. Science 303
1669-1674.
10
Cloned ESC Differentiate Into Different Tissue
Types
11
Cloned Embryonic Stem Cells Advantages/Problems
  • Advantages
  • No rejection, Perfect match
  • Problems
  • Extremely expensive (gt200,000/patient)
  • Only 0.6 (1 out of 176) oocytes survived to
    become a cell line (required 16 egg donors to
    produce one cell line)
  • Further improvements in SCNT protocols and in
    vitro culture systems are needed before
    contemplating the use of this technique for cell
    therapy.
  • Cloning damages DNA (virtually all cloned mammals
    suffer genetic damage)

12
Whats Wrong With Prop 71?
  • Fiscal problems
  • Political appointments
  • Informed consent modifications
  • Provision for backroom meetings
  • Exploitation of women for eggs
  • Limits funding to ESC and cloning
  • Deceptive claims
  • Deceptive list of potentially curable diseases

13
Prop 71 Adds 6 Billion to the California Deficit

14
Prop 71 3 Billion Bonds

Administrative 6
  • 6 of bond costs will be spent on administration
  • By comparison, the 2005 NIH budget commits 4 to
    administration

15
Prop 71 3 Billion Bonds

Indirect 25
  • 25 of bond costs will be spent on indirect costs
    (goes to institution)
  • For a 4 million grant, company or institution
    gets 1 million

16
Prop 71 3 Billion Bonds
  • 10 of bond costs will be spent on real estate
    and facilities construction
  • This is pure pork barrel politics, since
    investigators already have labs

17
Who Supports and Funds Prop 71?

18
Institute Run by Political Appointments
  • Citizen's Oversight Committee appointed by state
    politicians
  • Governor, Lieutenant Governor
  • Treasurer, Controller
  • Speaker of the Assembly
  • President Pro Tem of the Senate.
  • Consists of UC bureaucrats, members of disease
    advocacy groups

19
Prop 71 Will Change Informed Consent Procedures
  • Studies involving human subjects must inform
    patients about medical procedures to prevent
    abuse of patient rights
  • Proposition 71 initially requires grant
    recipients to comply with federal regulations
  • However, the proposition allows for
    modifications to adapt to the mission and
    objectives of the Institute. (ARTICLE 1.
    125281.06 (1))

20
Prop 71 Exempts Institute From Open Meeting" Laws
  • Closed meetings to hand out patents and profits
  • 125281.05 (d) Public Meeting Laws(3) In
    addition, the ICOC may conduct closed sessions
    when it meets to consider or discuss(B) Matters
    involving confidential intellectual property or
    work product, whether patentable or not,
    including, but not limited to, any formula, plan,
    pattern, process, tool, mechanism, compound,
    procedure, production data, or compilation of
    information

21
Prop 71 Will Exploit Poor Women for Their Eggs
  • Thousands of egg donors will be required to
    produce the eggs required for human cloning.
  • Poor women and college students will likely
    donate eggs to earn quick cash.
  • However, the procedure to obtain these eggs uses
    powerful, dangerous drugs that have already
    resulted in the deaths and hospitalization of
    hundreds of women.

22
Prop 71 Research Limited to Human Embryo Cloning
and Destruction
  • According to the legal text
  • In this regard, other research categories
    funded by the National Institute of Health shall
    not be funded by the Institute.
  • Funding of research that does not destroy human
    embryos must be approved by a 2/3 vote of the
    Scientific and Medical Research Funding Working
    Group

23
Why Do They Hide the Real Nature of Research
Funded?
24
Prop 71 Deceptive Claims
  • Royalties to the state
  • Sales tax will cover bond interest
  • Stem cell research is banned
  • Cures require use of embryonic cell lines
  • 400,000 embryos will be discarded anyway
  • Bush policy is based on ideology and not science

25
Prop 71 will Provide Patent and Royalty Revenues
to the State?
  • Proposition 71 does not require that one single
    penny of the patent and royalty revenues that
    might result from future research be returned to
    California taxpayers.
  • The Institute established by Proposition 71
    may, at its discretion, have taxpayers pay 100
    of the costs, and award venture capitalists with
    100 of the profits.

26
Sales Tax Generated by Prop 71 Will to Cover Bond
Interest?
  • The supporters own economic study shows that in
    the following nine years, when annual debt
    service on the bonds soars to more than 170
    million, the putative tax gains will cover only
    11 to 19 of that sum.
  • Michael Hiltzik, Los Angeles Times, 8/23/04

27
Prop 71 Claim Human ESC Research is Banned
  • Some of the most pioneering cures and treatments
    are right at our fingertips, but because of the
    stem cell ban, they remain beyond our reach.
    John Kerry
  • False
  • Human embryonic stem cell research for any
    purpose is allowed using private funds
  • Embryonic stem cell research is funded by the NIH
    for 22 available human lines created before 8/9/01

28
Prop 71 Claim Only Embryonic Cells Are
Pluripotent
  • Cells from the umbilical cords of newborns are
    pluripotent
  • Researchers have shown the ability of these cells
    to grow bone, cartilage, hematopoietic (blood),
    neural (brain, spinal cord, nerves), liver and
    heart tissue.

Reference Kögler, G. et al. 2004. A New Human
Somatic Stem Cell from Placental Cord Blood with
Intrinsic Pluripotent Differentiation Potential.
Journal of Experimental Medicine 200 123-135.
29
400,000 Embryos are Going to Be Discarded Anyway
  • 88.2 are being held for family building (i.e.,
    babies)
  • 2.2 are slated to be discarded
  • 2.8 are designated for research
  • Of these 11,000 embryos, optimistically, only 275
    cell lines would be expected to established

30
John Kerry Says George Bush Has politicized
science
  • While the Bush administration has politicized
    science, Kerry will put America back on the path
    of scientific excellence with a commitment to
    scientific research based on fact not ideology.

31
Prop 71 Diseases Claimed to be Treatable by ESC
32
Prop 71 Adult Stem Cells in Therapy of Cystic
Fibrosis
  • Successes have occurred using adult stem cells
    (not funded by this proposition) to generate new
    lung cells
  • Human cloning would be ineffective for this
    genetic disease.

Reference H. Spencer and A. Jaffe. 2004. The
potential for stem cell therapy in cystic
fibrosis. J. R. Soc. Med. 97 (Suppl. 44)5256.
33
Prop 71 Treatment of Spinal Cord Injuries
  • Both embryonic and adult stem cells (bone marrow,
    skin, and umbilical cord derived) have shown
    promise in treatment of spinal cord injuries.

References Oliver Brüstle, et. al. 1999.
Embryonic Stem Cell-Derived Glial Precursors A
Source of Myelinating Transplants. Science 285
754-756. Ankeny DP, McTigue DM, Jakeman LB. 2004.
Bone marrow transplants provide tissue protection
and directional guidance for axons after
contusive spinal cord injury in rats. Exp.
Neurol. 19017-31. Li HJ, et. al. 2004.
Transplantation of human umbilical cord stem
cells improves neurological function recovery
after spinal cord injury in rats. Zhongguo Yi Xue
Ke Xue Yuan Xue Bao 2638-42.
34
Prop 71 Embryonic Stem Cells as a Cure for
Alzheimers Disease?
  • I think the chance of doing repairs to
    Alzheimer's brains by putting in stem cells is
    small.Michael Shelanski, Taub Institute for
    Research on Alzheimer's Disease and the Aging
    Brain (Columbia University Medical Center)
  • To start with, people need a fairy tale.
    Ronald D.G. McKay, National Institute of
    Neurological Disorders and Stroke

Reference Rick Weiss. Stem Cells An Unlikely
Therapy for Alzheimer's. Washington Post
Thursday, June 10, 2004 Page A03
35
Prop 71 Embryonic Stem Cells as Treatment for
Diabetes?
  • Proponents cite studies in which cultured mouse
    embryonic stem cells produced insulin
  • However, these cells were not beta cells (of
    neurological derivation) and insulin secretion
    was very low and not glucose dependent

Reference S. Sipione et al. 2004. Insulin
expressing cells from differentiated embryonic
stem cells are not beta cells. Diabetologia 47
499-508.
36
Prop 71 Adult Stem Cells in Treatment of
Multiple Sclerosis
  • Adult stem cells (bone marrow or endogenous
    neural stem cells), but not embryonic stem cells
    have been used in numerous studies (including
    some preliminary clinical trials) to treat
    multiple sclerosis.

References Fassas A, Kimiskidis VK. 2004.
Autologous hemopoietic stem cell transplantation
in the treatment of multiple sclerosis rationale
and clinical experience. J. Neurol. Sci.
1553-58. Muraro PA, Cassiani Ingoni R, Martin R.
2003. Hematopoietic stem cell transplantation for
multiple sclerosis current status and future
challenges. Curr. Opin. Neurol. 16299-305.
37
Prop 71 Treatment of Amyotrophic Lateral
Sclerosis
  • Mouse model showed that cord blood stem cells are
    beneficial in reversing spinal cord injury, even
    when infused 5 days after injury.
  • A 2004 review of scientific literature indicated
    that adult stem cell treatments showed promise
    for treatment of ALS.

References Garbuzova-Davis, Svitlana, et al.
2003. Intravenous Administration of Human
Umbilical Cord Blood Cells in a Mouse Model of
Amyotrophic Lateral Sclerosis Distribution,
Migration, and Differentiation. Journal of
Hematotherapy and Stem Cell Research 12
255270. Silani V, Cova L, Corbo M, Ciammola A,
Polli E. 2004. Stem-cell therapy for amyotrophic
lateral sclerosis. Lancet 364200-2.
38
Both Adult and Embryonic Stem Cells Treat
Myocardial Infarction
  • Rat embryonic stem cells were used in rat model
    of myocardial infarction to improve ventricular
    function and repair damaged heart tissue
  • Mesenchymal stem cells (MSCs) when introduced
    into the infarcted heart, prevented deleterious
    remodeling and improved recovery

References Hodgson DM, et. al. 2004. Stable
benefit of embryonic stem cell therapy in
myocardial infarction. Am. J. Physiol. Heart
Circ. Physiol. 287H471-H479.Pittenger MF,
Martin BJ. 2004. Mesenchymal stem cells and their
potential as cardiac therapeutics. Circ. Res.
959-20.
39
Prop 71 Treatment of Cancer?
  • Cancer is caused by cells of the body multiplying
    uncontrollably due to genetic mutation or viral
    infection, in some cases.
  • Stem cells would not be useful in therapy. This
    wide spectrum of diseases was added simply
    because there are a lot of people who have been
    affected who might vote for the initiative.

40
Prop 71 Embryonic Stem Cells as Treatment for
Parkinsons?
  • Only 50 of rats experienced improvement of
    symptoms
  • 25 of rats developed brain tumors and died
  • Who wants to signup for the first clinical trial?

Reference Bjorklund, L. M., R. Sanchez-Pernaute,
et al. 2002. Embryonic stem cells develop into
functional dopaminergic neurons after
transplantation in a Parkinson rat model.
Proceedings of the National Academy of Sciences
99 2344-2349.
41
Prop 71 Treatment of Mental Health Diseases?
  • Since the cause of most mental health diseases is
    unknown, it is not known whether stem cells could
    be useful in therapy.
  • However, since many people suffer from these
    diseases, it was added to garner additional
    support for the proposition.

42
Prop 71 Embryonic Stem Cells as a Cure for
HIV/AIDS?
  • AIDS is caused by an infectious virus (HIV) that
    attacks the immune system
  • Stem cell treatments could improve the function
    of the immune system, but the effect would be
    temporary until the new stem cells became
    infected themselves
  • Adult (not embryonic) stem cells would be the
    preferred treatment

43
Adult Stem Cell SuccessLiver Cells from Bone
Marrow
  • Multipotent adult progenitor cells have been
    shown to differentiate into functional,
    hepatocyte-like (liver) cells.

Reference Schwartz, R. E., et al. 2002.
Multipotent adult progenitor cells from bone
marrow differentiate into functional
hepatocyte-like cells. Journal of Clinical
Investigation 109 1291-1302.
44
Adult Stem Cell Success Cord Blood Stem Cells
and Stroke
  • When umbilical cord-derived stem cells were given
    intravenously along with the drug mannitol, which
    can penetrate the brain's protective blood-brain
    barrier, stroke size was reduced by 40 percent.

Reference Cesar V. Borlongan, et al. 2004.
Central Nervous System Entry of Peripherally
Injected Umbilical Cord Blood Cells Is Not
Required for Neuroprotection in Stroke. Stroke
352385.
45
Adult Stem Cell SuccessNew Jaw Bone
  • Mans jaw bone was removed due to cancer
  • Replacement jaw bone was grown for 7 weeks in his
    back muscles using his own adult stem cells
    enclosed in a titanium frame with cow-derived
    bone mineral blocks and human bone growth factor

Reference Rookmaaker MB, Verhaar MC, Van
Zonneveld AJ, Rabelink TJ. 2004. Progenitor cells
in the kidney Biology and therapeutic
perspectives. Kidney Int. 66518-22.
46
Adult Stem Cell Success Kidney Stem Cells
  • Stem cells have been demonstrated in the kidneys
  • Adult stem cells can dedifferentiate into
    progenitors
  • Stem cells from alternate sources can be
    differentiated into kidney cells

Reference Rookmaaker MB, Verhaar MC, Van
Zonneveld AJ, Rabelink TJ. 2004. Progenitor cells
in the kidney Biology and therapeutic
perspectives. Kidney Int. 66518-22.
47
Adult Stem Cell Success Stem Cells for Hearing
Loss
  • Stem cells in the adult inner ear are capable of
    differentiating into hair cells

Reference Li H, Corrales CE, Edge A, Heller S.
2004. Stem cells as therapy for hearing loss.
Trends Mol Med. 10309-15.
48
Adult Stem Cell Success Corneas From Adult MSC
  • Adult stem cells taken from patients were grown
    in culture before transplantation onto the
    damaged eyes. Sixteen of the 20 patients had
    improved vision.
  • Reference
  • Schwab, IR et al. 2000. Successful
    transplantation of bioengineered tissue
    replacements in patients with ocular surface
    disease. Cornea 19 421-426.

49
Adult Stem Cell Success Treatment of Retinitis
Pigmentosa
  • An injection of adult stem cells saved the sight
    of mice who would otherwise have gone blind.
  • Such treatment could be used for a group of eye
    diseases called retinitis pigmentosa, in which
    cells in the retina break down over time, causing
    gradual loss of vision and sometimes blindness.
  • Reference
  • Otani A., et al. 2004. Rescue of retinal
    degeneration by intravitreally injected adult
    bone marrowderived lineage-negative
    hematopoietic stem cells. J. Clin. Invest., 114.
    765 - 774.

50
Adult Stem Cells Work as Well as Embryonic Stem
Cells
  • Both adult mesenchymal stem cells and embryonic
    stem cells produced teeth in mice

Reference Ohazama A, Modino SA, Miletich I,
Sharpe PT. 2004. Stem-cell-based tissue
engineering of murine teeth. J. Dent. Res.
83518-522.
51
Summary of Advantages/Disadvantages
52
Embryonic Stem Cell Problems Chromosomal
Abnormalities
  • Recently, abnormalities in chromosome number and
    structure were found in three human ESC lines.
  • References
  • Draper, J.S., et al., "Recurrent gain of
    chromosomes 17q and 12 in cultured human
    embryonic stem cells," Nature Biotechnology
    December 7, 2003, advance online publication.
  • C. Cowan et al. 2004. Derivation of Embryonic
    Stem-Cell Lines from Human Blastocysts. New
    England Journal of Medicine 350 1353-1356.

53
Embryonic Stem Cell Problems Epigenetic Defects
  • increasing evidence from a range of mammals
    shows a propensity for epigenetic errors with
    embryo technologies. If paralleled in human
    embryos, the effect on tumorigenic and
    differentiation properties of embryonic stem
    cells needs to be established.
  • Reference
  • Allegrucci C, Denning C, Priddle H, Young L.
    2004. Stem-cell consequences of embryo epigenetic
    defects. Lancet 10364(9429)206-8.

54
Embryonic Stem Cell Problems Cancer and Tumors
  • Rapid growth of embryonic stem cells brings the
    potential of introducing cancer into patients.
  • An embryonic stem cell therapy stroke model in
    mice found that treated mice developed highly
    malignant teratocarcinomas at the site of
    implantation, even when pre-differentiated into
    neural cells.

Reference Erdo F, Trapp T, Buhrle C, Fleischmann
B, Hossmann KA. 2004. Embryonic stem cell therapy
in experimental stroke host-dependent malignant
transformation. Orv. Hetil. 1451307-1313.
55
Embryonic Cloning Problems Not Enough Human Eggs
  • The poor availability of human oocytes (eggs),
    the low efficiency of the nuclear cell procedure,
    and the long population-doubling time of human ES
    cells make it difficult to envision this
    therapeutic cloning to obtain stem cells
    becoming a routine clinical procedure even if
    ethical considerations were not a significant
    point of contention

Reference Odorico JS, Kaufman DS, Thomson JA.
2001. Multilineage differentiation from human
embryonic stem cell lines. Stem Cells 19193-204.
56
Embryonic Stem Cell Problems Tissue Rejection
  • Possibility of rejection of stem cell transplants
    as foreign tissues is very high.
  • Hundreds of thousands of stem cell lines would be
    required to serve the majority of patients

57
Whats Wrong With Adult Stem Cells?
  • Cant be patented, since they are derived from
    the patient
  • Cant be marketed and sold at inflated prices due
    to inability to patent

58
Is the Embryo Human Life?
Laurie Zoloth, Northwestern University
  • Brownback "What would have happened had we
    experimented on you at the blastocyst stage?"
  • Zoloth "Well, that's an obvious question, If I
    was... It's an odd theoretical one. If I could
    somehow be . . ."
  • Brownback "It's not a theoretical, I'm just
    asking biologically."
  • Zoloth "If I could have been taken out of my
    mother's womb, which is different from our
    situation..."
  • Brownback "What if it happened to you?"
  • Zoloth "Then I wouldn't . . . I wouldn't have
    existed."

Testimony before the US Senate 9/29/2004
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