 |
 |
Bob, Please give my best to your wife. I am a pilgrim on my path. She is a survivor! I congratulate the people and the House of Lords of the UKfor their foresight. I am impressed with their view of the future and their realistic approach to the potential fortune ahead. Please include me when you share the final results to xxii. E of the headdress From: "Bob Martone" <[log in to unmask]> To: <[log in to unmask]> Sent: Wednesday, February 27, 2002 8:24 PM Subject: House of Lords conclusions and recommendations 2/27/2002 > Conclusions and recommendations > The Committee's detailed conclusions and recommendations are > as follows: > > stem cell research > > (i) Stem cells appear to have great therapeutic potential > for the treatment of many disorders that are both common and > serious and for the repair of damaged tissue. > (ii) Until recently most research on stem cells has > focussed on ES cells from animals and the derivation of ES > cell lines from them; cell lines from human ES cells have > the potential to provide a basis for a wide range of > therapies. > > (iii) Recent research on adult stem cells, including stem > cells from the placenta and umbilical cord, also holds > promise of therapies; and research on them should be > strongly encouraged by funding bodies and the Government. > > (iv) To ensure maximum medical benefit it is necessary to > keep both routes to therapy open at present since neither > alone is likely to meet all therapeutic needs. > > (v) For the full therapeutic potential of stem cells, > both adult and ES, to be realised, fundamental research on > ES cells is necessary, particularly to understand the > processes of cell differentiation and dedifferentiation. > > (vi) Future developments might eventually make further > research on ES cells unnecessary. This is unlikely in the > foreseeable future; in the meantime there is a strong > scientific and medical case for continued research on human > ES cells. (i-vi paragraph 3.22) > > status of the early embryo > > (vii) Whilst respecting the deeply held views of those > who regard any research involving the destruction of a human > embryo as wrong and having weighed the ethical arguments > carefully, the Committee is not persuaded, especially in the > context of the current law and social attitudes, that all > research on early human embryos should be prohibited > (paragraph 4.21). > (viii) Fourteen days should remain the limit for research > on early embryos. (paragraph 4.22) > > (ix) Embryos should not be created specifically for > research purposes unless there is a demonstrable and > exceptional need which cannot be met by the use of surplus > embryos. (paragraph 4.28) > > cell nuclear replacement and cloning > > (x) Basic research is a necessary step to developing > treatments and facilitating the potential use of adult stem > cells and should be permitted under the Regulations in the > same way as more directly applied research to which it is > designed to lead, provided that it is subject to strict > regulation. (paragraph 5.4) > (xi) Although there is a clear distinction between an IVF > embryo and an embryo produced by CNR (or other methods) in > their method of production, the Committee does not see any > ethical difference in their use for research purposes up to > the 14 days limit. (paragraph 5.13) > > (xii) Even if CNR is not itself used directly for many > stem cell-based therapies, there is still a powerful case > for its use, subject to strict regulation by the HFEA, as a > research tool to enable other cell-based therapies to be > developed. However, as with embryos created by IVF for > research, CNR embryos should not be created for research > purposes unless there is a demonstrable and exceptional need > which cannot be met by the use of surplus embryos. > (paragraph 5.14) > > (xiii) If CNR is permitted in certain limited > circumstances, oocyte nucleus transfer should also be > allowed for research purposes. (paragraph 5.20) > > (xiv) Given the high risk of abnormalities the scientific > objections to human reproductive cloning are currently > overwhelming. (paragraph 5.21) > > (xv) There are further strong ethical objections in > addition to those based on the risk of abnormalities, > although not all the arguments deployed against reproductive > cloning are equally valid. The most powerful are the > unacceptability of experimenting on a human being and the > familial and child welfare considerations arising from the > ambiguity of the cloned child's relationships. (paragraph > 5.21) > > (xvi) The Committee unreservedly endorses the legislative > prohibition on reproductive cloning now contained in the > Human Reproductive Cloning Act 2001. (paragraph 5.21) > > (xvii) The HFEA has an excellent record in ensuring that > IVF clinics comply with the law, and we are satisfied that > its regulatory powers, now reinforced by a specific > statutory prohibition, provide sufficient protection against > the development of CNR leading to reproductive cloning in > the United Kingdom. (paragraph 5.24) > > (xviii) The Government should take an active part in any > move to negotiate an international ban on human reproductive > cloning. (paragraph 7.22) > > legislation and regulation > > (xix) At an appropriate time, perhaps towards the end of > the decade, the Government should undertake a further review > of scientific developments, particularly of the progress of > adult stem cell research and therapies, and of the > development of stem cell banks, with a view to determining > whether research on human embryos is still necessary. > (paragraph 8.4) > > (xx) The Government should keep the funding of the HFEA > under review and ensure that its resources are commensurate > with its increased responsibilities. (paragraph 8.5) > > (xxi) The HFEA and the Department of Health should > consider how a review of the outcomes of research licensed > under the Act might be undertaken and updated on a regular > basis (paragraph 8.6) > > (xxii) The Department of Health should examine with the > HFEA the possibility of drawing up indicative guidance as to > what constitutes serious disease (paragraph 8.9) > > (xxiii) When the Government bring forward legislation > they should consider making express provision for such basic > research as is necessary as a precursor for the development > of cell-based therapies (paragraph 8.15) > > (xxiv) The separation of clinical and research roles > should be standard practice for donation of eggs or embryos. > The prohibition in the United Kingdom of payment to donors > for gametes has been an important element in preventing > undesirable commercialisation of this aspect of assisted > reproduction and should be strictly maintained (paragraph > 8.21) > > (xxv) The Department of Health should consider either > establishing a body similar to the Gene Therapy Advisory > Committee with oversight of clinical studies involving stem > cells, or extending the membership and remit of GTAC to > achieve the same ends. The Committee sees no other special > need at present for additional regulation of the use of stem > cells in the treatment of patients (paragraph 8.23) > > (xxvi) The Department of Health's proposals to establish > a stem cell bank overseen by a steering committee, > responsible for the custody of stem cell lines, ensuring > their purity and provenance and monitoring their use, are > endorsed. As a condition of granting a research licence, the > HFEA should require that any ES cell line generated in the > United Kingdom in the course of that research is deposited > in the bank. Before granting any new licence to establish > human ES cell lines, the HFEA should satisfy itself that > there are no existing ES cell lines in the bank suitable for > the proposed research. (paragraph 8.29) > > > (xxvii) The HFEA should ensure that the implications > arising from the "immortality" of stem cell lines are fully > covered in obtaining informed consent from donors giving > embryos for the potential establishment of ES cell lines for > research. To prevent future restrictions in using ES cell > lines (and therefore minimise the need to generate new ES > cell lines) the HFEA should not permit ES cell lines be > generated from donated embryos unless informed consent > places no specific constraint on their future use. Where > parents wish to restrict the type of research which can be > undertaken, for example specifically for reproductive > purposes, the embryos donated should be used for purposes > other than the generation of ES cell lines. (paragraph 8.33) > ------------------------------------------------------------ > -------------------- > > > > Bob Martone > [log in to unmask] > http://www.samlink.com/~bmartone > > ---------------------------------------------------------------------- > To sign-off Parkinsn send a message to: mailto:[log in to unmask] > In the body of the message put: signoff parkinsn ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn