Missouri Prop 2

[Danoinark]

Phil

I am sure other States are watching Missouri's issue. Not being well informed of the debate I am looking forward to learning more about it. I guess my question would be if it helps another human how can that be a bad thing. Could this not be by design of the Creator?

Dano

[gonefishin]

Here is a question. If Stem Cell Research is a legitimate pursuit why does it have to be voted on? I still believe it is nothing more than a money issue. Research centers want the tax payers to foot the bill for the research and then they, the researchers, will sell any resulting patents for millions, billions or trillions. In any other market the people footing the bill would be called shareholders and would share in any resulting income. I would certainly be more interested in this proposition if the tax payers in MO were made individual shareholders.

[Phil Lilley]

To clarify my 'Creator' comment- when man reaches the point of being able to manipulate the building blocks of humans beings and actually create life, so-to-speak, I can see God stepping in. That's a broad statement, mind you. I'm not an avocate of the world ending soon, although in this age of nuks in the hands of terrists and rogue nations, it very well could. I'm just saying man has come to the place in time where he has absolutely no fear of God and consequences of our actions.

[crappiefisherman]

Very well stated Phil. I believe in hillbilly easy to understand terms, that when a baby is concieved,(sperm and egg meet and join) there is no turning back,(uterus or petri dish), I also believe in heredity, will they cure a man of cancer and give him diabetees or heart conditions?

[Danoinark]

I agree that I certainly wouldn't want my tax dollars to go to subsidizing stem cell research. That is a function of scientists and companies in that business. I liken it to a state paying for testing or developing of a new medication. Its just not a function of government, State or Federal. My feelings are that its logical to think that the Creator gave those the knowledge to develop a new life saving or pain saving procedure through stem cells. But what they do with that knowledge becomes the issue. Just how far do we go. Creating "cloning" would be out of the question as that is not our design. We cannot have the mass assembly line production of embyro's for medical use that I could see happen out of this. New business venture's sprouting where men and women are paid for thier contributions. Hopefully our scientists, medical ethicist and religous leaders will come together for a common good and make proper decisions without taxpayer involvement. Danol

[Al Agnew]

Here is a question. If Stem Cell Research is a legitimate pursuit why does it have to be voted on? I still believe it is nothing more than a money issue. Research centers want the tax payers to foot the bill for the research and then they, the researchers, will sell any resulting patents for millions, billions or trillions. In any other market the people footing the bill would be called shareholders and would share in any resulting income. I would certainly be more interested in this proposition if the tax payers in MO were made individual shareholders.

C'mon, gonefishin', you know why it has to be voted on in this state. It's because the pro-life people are opposed to doing anything with a fertilized egg except letting it take its natural course, and they have a lot of power and support in Missouri. It has a lot to do with money, yes. But it's NOT being voted on to force Missouri taxpayer money to go to stem cell research. And, you could maybe look upon it as if Missouri residents WERE going to get monetary benefit from it, since the companies wanting to do the research are and will be putting money into the state's tax coffers.

Again, read the text of the bill. Yes, you could maybe make a case that if an entity is getting money from the state for another purpose, and decides to do stem cell research, then it's getting money for one thing that frees it up to do another. But that's kinda like throwing the baby out with the bath water...if a university or other entity is doing stuff that is enough in the public interest that the state feels like it deserves support, it's still doing the stuff that deserves support even after it starts doing stem cell research.

And, of course somebody is going to profit from stem cell research. That's capitalism. Even if the state would be helping fund the research, are you gonna not use the results--and deny the benefits to yourself and others--simply because somebody is making money off it? That's also throwing out the baby with the bath water.

Phil, obviously a blastocyst is a fetus, in very early stages of development (note that the bill says no more than 14 days of development). That's the whole crux of the matter, and why the pro-life people are opposed to tampering with it. If you believe that a group of mostly undifferentiated cells (no brain or other recognizable organs yet) is a fully human being with all the rights of such, and with a soul or whatever it is that makes us human, then you WILL be opposed to this kind of research, as well as all abortions, the morning after pill, and in vitro fertilization (since in vitro produces a lot of extra fertilized eggs that are eventually thrown away). But seems to me this is mostly a religious viewpoint, and one not shared by everybody. We don't KNOW whether a group of cells that is not sentient (because it hasn't developed a brain yet) and not yet recognizable as human has a soul (or even IF there is such a thing as a soul). I don't want this to go into a religious argument, but that really is the whole basis for opposition to stem cell research. That's what the vote will be about, whether we want to take that religious viewpoint as a whole state...whether the state government will operate under that religious viewpoint in regards to this issue.

Personally, it's a religious viewpoint that I don't share. And it goes against my grain to have to operate under somebody else's religious viewpoint when that viewpoint denies research on something that harms no one except a blastocyst, and has the potential to help so many.

[Phil Lilley]

National Academies Guidelines for Research on Human Embryonic Stem Cells

http://fermat.nap.edu/books/0309096537/html/97.html

This is interesting reading.

http://fermat.nap.edu/openbook.php?record_...78&page=123

OCR for page 123

Guidelines for Human Embryonic Stem Cell Research Appendix A Compilation of Recommendations RECOMMENDATIONS FROM CHAPTER 3 Recommendation 1: To provide local oversight of all issues related to derivation and research use of hES cell lines and to facilitate education of investigators involved in hES cell research, all institutions conducting hES cell research should establish an Embryonic Stem Cell Research Oversight (ESCRO) committee. The committee should include representatives of the public and persons with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction, and ethical and legal issues in hES cell research. The ESCRO committee would not substitute for an Institutional Review Board but rather would provide an additional level of review and scrutiny warranted by the complex issues raised by hES cell research. The committee would also serve to review basic hES cell research using preexisting anonymous cell lines that does not require consideration by an Institutional Review Board. Recommendation 2: Through its Embryonic Stem Cell Research Oversight (ESCRO) committee, each research institution should ensure that the provenance of hES cells is documented. Documentation should include evidence that the procurement process was approved by an Institutional Review Board to ensure adherence to the basic ethical and legal principles of informed consent and protection of confidentiality.

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Guidelines for Human Embryonic Stem Cell Research Recommendation 3: Embryonic Stem Cell Research Oversight (ESCRO) committees or their equivalents should divide research proposals into three categories in setting limits on research and determining the requisite level of oversight: (a) Research that is permissible after notification of the research institution’s ESCRO committee and completion of the reviews mandated by current requirements. Purely in vitro hES cell research with pre-existing coded or anonymous hES cell lines in general is permissible provided that notice of the research, documentation of the provenance of the cell lines, and evidence of compliance with any required Institutional Review Board, Institutional Animal Care and Use Committee, Institutional Biosafety Committee, or other mandated reviews is provided to the ESCRO committee or other body designated by the investigator’s institution. ( Research that is permissible only after additional review and approval by an ESCRO committee or other equivalent body designated by the investigator’s institution. The ESCRO committee should evaluate all requests for permission to attempt derivation of new hES cell lines from donated blastocysts, from in vitro fertilized oocytes, or by nuclear transfer. The scientific rationale for the need to generate new hES cell lines, by whatever means, should be clearly presented, and the basis for the numbers of blastocysts or oocytes needed should be justified. Such requests should be accompanied by evidence of Institutional Review Board approval of the procurement process. All research involving the introduction of hES cells into nonhuman animals at any stage of embryonic, fetal, or postnatal development should be reviewed by the ESCRO committee. Particular attention should be paid to the probable pattern and effects of differentiation and integration of the human cells into the nonhuman animal tissues. Research in which personally identifiable information about the donors of the blastocysts, gametes, or somatic cells from which the hES cells were derived is readily ascertainable by the investigator also requires ESCRO committee review and approval. © Research that should not be permitted at this time: Research involving in vitro culture of any intact human embryo, regardless of derivation method, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first. Research in which hES cells are introduced into nonhuman primate blastocysts or in which any ES cells are introduced into human blastocysts.

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Guidelines for Human Embryonic Stem Cell Research In addition: No animal into which hES cells have been introduced at any stage of development should be allowed to breed. Recommendation 4: Through its Embryonic Stem Cell Research Oversight (ESCRO) committee, each research institution should establish and maintain a registry of investigators conducting hES cell research and record descriptive information about the types of research being performed and the hES cells in use. Recommendation 5: If a U.S.-based investigator collaborates with an investigator in another country, the Embryonic Stem Cell Research Oversight (ESCRO) committee may determine that the procedures prescribed by the foreign institution afford protections equivalent with these guidelines and may approve the substitution of some or all of the foreign procedures for its own. Recommendation 6: A national body should be established to assess periodically the adequacy of the guidelines proposed in this document and to provide a forum for a continuing discussion of issues involved in hES cell research. Recommendation 7: The hES cell research community should ensure that there is sufficient genetic diversity among cell lines to allow for potential translation into health-care services for all groups in our society. RECOMMENDATIONS FROM CHAPTER 4 Recommendation 8: Regardless of the source of funding and the applicability of federal regulations, an Institutional Review Board or its equivalent should review the procurement of gametes, blastocysts, or somatic cells for the purpose of generating new hES cell lines, including the procurement of blastocysts in excess of clinical need from in vitro fertilization clinics, blastocysts made through in vitro fertilization specifically for research purposes, and oocytes, sperm, and somatic cells donated for development of hES cell lines derived through nuclear transfer. Recommendation 9: Institutional Review Boards may not waive the requirement for obtaining informed consent from any person whose somatic cells, gametes, or blastocysts are used in hES research.

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Guidelines for Human Embryonic Stem Cell Research Recommendation 10: Investigators, institutions, Institutional Review Boards, and privacy boards should ensure that authorizations are received from donors, as appropriate and required by federal human subjects protections and the Health Insurance Portability and Accountability Act for the confidential transmission of personal health information to repositories or to investigators who are using hES cell lines derived from donated materials. Recommendation 11: Investigators and institutions involved in hES cell research should conduct the research in accordance with all applicable laws and guidelines pertaining to recombinant DNA research and animal care. Institutions should consider adopting Good Laboratory Practice standards for some or all of their basic hES cell research. Recommendation 12: hES cell research leading to potential clinical application must be in compliance with all applicable Food and Drug Administration (FDA) regulations. If FDA requires that a link to the donor source be maintained, investigators and institutions must ensure that the confidentiality of the donor is protected, that the donor understands that a link will be maintained, and that, where applicable, federal human subjects protections and Health Insurance Portability and Accountability Act or other privacy protections are followed. RECOMMENDATIONS FROM CHAPTER 5 Recommendation 13: When donor gametes have been used in the in vitro fertilization process, resulting blastocysts may not be used for research without consent of all gamete donors. Recommendation 14: To facilitate autonomous choice, decisions related to the production of embryos for infertility treatment should be free of the influence of investigators who propose to derive or use hES cells in research. Whenever it is practicable, the attending physician responsible for the infertility treatment and the investigator deriving or proposing to use hES cells should not be the same person. Recommendation 15: No cash or in kind payments may be provided for donating blastocysts in excess of clinical need for research purposes.

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Guidelines for Human Embryonic Stem Cell Research Recommendation 16: Women who undergo hormonal induction to generate oocytes specifically for research purposes (such as for nuclear transfer) should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an Institutional Review Board. No cash or in kind payments should be provided for donating oocytes for research purposes. Similarly, no payments should be made for donations of sperm for research purposes or of somatic cells for use in nuclear transfer. Recommendation 17: Consent for blastocyst donation should be obtained from each donor at the time of donation. Even people who have given prior indication of their intent to donate to research any blastocysts that remain after clinical care should nonetheless give informed consent at the time of donation. Donors should be informed that they retain the right to withdraw consent until the blastocysts are actually used in cell line derivation. Recommendation 18: In the context of donation of gametes or blastocysts for hES cell research, the informed consent process, should, at a minimum, provide the following information: A statement that the blastocysts or gametes will be used to derive hES cells for research that may include research on human transplantation. A statement that the donation is made without any restriction or direction regarding who may be the recipient of transplants of the cells derived, except in the case of autologous donation. A statement as to whether the identities of the donors will be readily ascertainable to those who derive or work with the resulting hES cell lines. If the identities of the donors are retained (even if coded), a statement as to whether donors wish to be contacted in the future to receive information obtained through studies of the cell lines. An assurance that participants in research projects will follow applicable and appropriate best practices for donation, procurement, culture, and storage of cells and tissues to ensure, in particular, the traceability of stem cells. (Traceable information, however, must be secured to ensure confidentiality.) A statement that derived hES cells and/or cell lines might be kept for many years. A statement that the hES cells and/or cell lines might be used in research involving genetic manipulation of the cells or the mixing of human and nonhuman cells in animal models.

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Guidelines for Human Embryonic Stem Cell Research Disclosure of the possibility that the results of study of the hES cells may have commercial potential and a statement that the donor will not receive financial or any other benefits from any future commercial development; A statement that the research is not intended to provide direct medical benefit to the donor(s) except in the case of autologous donation. A statement that embryos will be destroyed in the process of deriving hES cells. A statement that neither consenting nor refusing to donate embryos for research will affect the quality of any future care provided to potential donors. A statement of the risks involved to the donor. Recommendation 19: Consenting or refusing to donate gametes or embryos for research should not affect or alter in any way the quality of care provided to prospective donors. That is, clinical staff must provide appropriate care to patients without prejudice regarding their decisions about disposition of their embryos. Recommendation 20: Clinical personnel who have a conscientious objection to hES cell research should not be required to participate in providing donor information or securing donor consent for research use of gametes or blastocysts. That privilege should not extend to the care of a donor or recipient. Recommendation 21: Researchers may not ask members of the infertility treatment team to generate more oocytes than necessary for the optimal chance of reproductive success. An infertility clinic or other third party responsible for obtaining consent or collecting materials should not be able to pay for or be paid for the material obtained (except for specifically defined cost-based reimbursements and payments for professional services). Recommendation 22: Institutions that are banking or plan to bank hES cell lines should establish uniform guidelines to ensure that donors of material give informed consent through a process approved by an Institutional Review Board, and that meticulous records are maintained about all aspects of cell culture. Uniform tracking systems and common guidelines for distribution of cells should be established.

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Guidelines for Human Embryonic Stem Cell Research Recommendation 23: Any facility engaged in obtaining and storing hES cell lines should consider the following standards: (a) Creation of a committee for policy and oversight purposes and creation of clear and standardized protocols for banking and withdrawals. ( Documentation requirements for investigators and sites that deposit cell lines, including A copy of the donor consent form. Proof of Institutional Review Board approval of the procurement process. Available medical information on the donors, including results of infectious-disease screening. Available clinical, observational, or diagnostic information about the donor(s). Critical information about culture conditions (such as media, cell passage, and safety information). Available cell line characterization (such as karyotype and genetic markers). A repository has the right of refusal if prior culture conditions or other items do not meet its standards. © A secure system for protecting the privacy of donors when materials retain codes or identifiable information, including but not limited to A schema for maintaining confidentiality (such as a coding system). A system for a secure audit trail from primary cell lines to those submitted to the repository. A policy governing whether and how to deliver clinically significant information back to donors. (d) The following standard practices: Assignment of a unique identifier to each sample. A process for characterizing cell lines. A process for expanding, maintaining, and storing cell lines. A system for quality assurance and control. A website that contains scientific descriptions and data related to the cell lines available. A procedure for reviewing applications for cell lines. A process for tracking disbursed cell lines and recording their status when shipped (such as number of passages). A system for auditing compliance. A schedule of charges.

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Guidelines for Human Embryonic Stem Cell Research A statement of intellectual property policies. When appropriate, creation of a clear Material Transfer Agreement or user agreement. A liability statement. A system for disposal of material. (e) Clear criteria for distribution of cell lines, including but not limited to evidence of approval of the research by an Embryonic Stem Cell Research Oversight committee or equivalent body at the recipient institution.

*************

I'm going to go alittle further with my search but it seems the Al's statement Text of the initiative SPECIFICALLY PROHIBITS donation of eggs or blastocysts used in stem cell research for money. can't be true because the practice is already happening, according to this document.

I would also interject this thought about amendments- depending on who writes the text (lawyers) and who edite the text (lawyers), there are those (lawyers) who can get around roadblocks in the text after the amnedment is passed... ie. gambling "boats" on rivers whicn now are not actually boats but 'close' to water- say within a mile or two.

I am not a lawyer but I question the strength of this amendment's language to keep research companies from an all out assault on our medical ethics codes.

More research.

[Kicknbass]

Personally, it's a religious viewpoint that I don't share. And it goes against my grain to have to operate under somebody else's religious viewpoint when that viewpoint denies research on something that harms no one except a blastocyst, and has the potential to help so many.

Al, I don't agree that it is strictly a religious issue. I see it as a human rights issue as well. Where do you draw the line as to taking human life. I think we can agree that taking of life of an inocent baby is wrong, but this baby will survive if taking from the mother at late stages of pregnacy, and at early stages will continue to develop without intervention. Who has the rights...the mother...the father....how about the fetus. The only clear place of distinction is conception. Any time after that is guess work..striping the right to life away from a human being in the most early stages of life that if left to develope undistured will be borned in this world.

So taking the life of a fertilized embryo strips the embryo of the right to life. Would you avoacate doing research on death row inmates. What a waste to eliminate such a valuable speciman that is going to be put to death. I am sure that alot of valuable discoveries could come from this research as well, but I don't think you would aree that this would be right.

As I understand the issue, research can currently be performed on embronic stem cells. The change in the law just requires the public to pay the bill. If it is so profitable, then why should the research be paid from the public tax dollars.. Let the people such as yourself that think it is such a form of research reach into your pockets and pay the toll. There are many when funded organizations that can raise the required funding.

My 2 cents.

[crappiefisherman]

Prersident Bush vetos embryonic stem cell bill, Sept.25, 2006 http:/www.cnn.com/2006/POLITICS/07/19/stemcells.veto/index.html

[Al Agnew]

Phil...we're not talking about the guidelines you quoted. We're talking about the specific language of the initiative. IN MISSOURI, if the initiative passes, stem cells CANNOT come from eggs or blastocysts donated for money. Period. The language in the initiative is VERY clear on this. If the initiative FAILS, the current practice in Missouri as in other state, which may mean paying for eggs or blastocysts, remains in effect (unless and until the state legislature bans it, or bans all embryonic stem cell research). As for attorneys twisting the language...if I can read it and understand it perfectly, and I'm no lawyer, seems to me that it's pretty clear and straightforward.

Kickinbass, in the area of human rights, you have a valid opinion. I happen to have a different one. And, according to your opinion, there should be NO in vitro fertilization, because it almost always results in extra embryos that will eventually be discarded (or killed, if you prefer).

As to your other assertion, you are flat out wrong. Embryonic stem cell research is, at present, permitted in Missouri, but the reason for the initiative is that the MO Legislature has repeatedly and will continue to repeatedly attempt to ban it, since there is at present no law that affirms that it can take place. And, as I said before, just READ THE TEXT of the initiative. It does NOT require the public to pay the bill. It says that the state cannot withhold funding earmarked for other purposes from entities doing stem cell research. There is nothing that says that the state can't specifically say that any money they provide WILL NOT go to stem cell research, which is pretty much the way things are now.