The Parkinson’s Action Network (PAN) is a founding member of the Coalition for the Advancement of Medical Research (CAMR), the nation's leading bipartisan pro-cures coalition. PAN works closely with CAMR to advocate for the advancement of breakthrough research and technologies in regenerative medicine in the hope of finding better treatments and a cure for Parkinson’s disease. Amy Comstock Rick, PAN CEO, also is the President of CAMR. Together, PAN and CAMR will continue to educate the nation about the importance of medical and scientific research, including embryonic stem cell research.
Helping to Ensure Strong Federal Support for Embryonic Stem Cell Research –
Background:
On March 9th, President Obama issued an Executive Order instructing the National Institutes of Health (NIH) to develop guidelines to establish a framework for federal funding of embryonic stem cell research. The NIH, in implementing the Executive Order, recently published draft guidelines in the Federal Register. The full text can be obtained at http://edocket.access.gpo.gov/2009/pdf/E9-9313.pdf. The public had thirty days to submit comments on the draft guidelines.
The Parkinson's community worked to ensure that NIH received as many supportive comments as possible. The Executive Order was a major step forward, but as with many complex
issues, there were details of the draft guidelines that should be
changed and/or clarified to ensure the framework created builds on
current progress. NIH will review the content and volume of comments as it drafts its final guidelines, expected to be issued on or before July 7th. Please click here to view PAN's comments on the NIH draft guidelines.
In addition to providing comments, the Parkinson's community urged their Representatives to sign-on to a letter to the NIH in support of the draft stem cell guidelines and embryonic stem cell research. The letter was signed by 139 Representatives. The letter praised the NIH for issuing draft guidelines that would support this crucial research and offered revisions for the final guidelines. To see if your Representative signed on, please click here.
Draft Guidelines Summary:
The draft guidelines establish a framework for federal funding of embryonic stem cells that were derived from embryos created for reproductive purposes and were in excess of clinical need. In addition, to be eligible for federal funding, the guidelines impose significant eligibility criteria on the donation process of the embryo used to derive the stem cell line. The criteria include:
• All options for the use of the embryos were explained to the donor;
• No inducements were offered for the donation;
• A policy was in place at the facility where the embryos were donated that ensures that the decision to donate embryos for research would not affect the quality of care provided;
• There was a separation between the donor’s decision to create embryos for reproductive purposes and the donor’s decision to donate embryos for research;
• Consent for the donation was obtained at the time of donation from the individual who sought reproductive services;
• Whenever practicable, the physician responsible for the donor’s reproductive clinical care was not the same person as the researcher deriving the stem cells; and
• Written informed consent was obtained from individuals who sought reproductive services and who elected to donate embryos for research purposes (specific criteria is listed for the informed consent process).
We believe that these ethical parameters are appropriate for new stem cell lines that are created in 2009 and thereafter. Unfortunately, the draft guidelines do not explicitly ensure that current lines that are already being used in research will be eligible for federal funding. It is our recommendation that the final guidelines include a provision that allows for inclusion of current lines, already being used in very important research, if those lines were derived using the prevailing ethical practices at the time.
The draft guidelines prohibit federal funding of research using embryonic stem cells derived from other sources such as somatic cell nuclear transfer (SCNT), IVF embryos created for research purposes, and parthenogenesis. It is our belief that these very promising research techniques have potential that is beyond what is possible with embryonic stem cell lines that are derived from the IVF process and should be eligible for federal funding.
110th Congress History:
On January 11, 2007, the U.S. House of Representatives passed H.R. 3, legislation to expand embryonic stem cell research, by a vote of 253-174, with eight Members not voting. The Senate voted on the companion bill, S. 5, on April 11, 2007, by a vote of 63-34 with three Senators not voting. S.5 passed the House of Representatives June 7, 2007 by a vote of 247-176 with ten members not voting. The president vetoed S. 5 on June 20, 2007.
Why is hESC research important for people with Parkinson’s?
Embryonic stem cell research has significant scientific and therapeutic potential for people living with Parkinson’s disease. While replacement of human dopamine producing neurons may be one therapy resulting from additional embryonic stem cell research, many avenues of Parkinson’s research will benefit from this legislation and expansion of the current policy. Researchers will be aided in studying the causes of Parkinson’s, developing more accurate models to improve our understanding of the disease, and, ultimately, halt the unrelenting neurological degeneration and loss of quality of life for Parkinson’s patients.
What is in vitro fertilization (IVF ) and what does it have to do with stem cells?
Everything. Embryonic stem cells are derived from in vitro fertilized (IVF) embryos that are developed in excess of those needed for the process to allow infertile couples to have children. The IVF process results in more embryos than are needed by the couple. There are estimated to be more than 400,000 IVF embryos, which are currently frozen and will likely be destroyed if not donated, with informed consent and no compensation, for research.
What options are available to couples who have just participated in the IVF process, who most likely have excess embryos?
Disposal or freezing for future use. Some clinics offer the additional options of embryo adoption or donation to limited private research. Faced with this decision, many couples would prefer to donate their embryos to research. Unfortunately, this option is currently very restricted.
The Stem Cell Research Enhancement Act allows federally-funded scientists the ability to do research on privately-derived stem cell lines created from embryos couples donated to help alleviate pain and suffering from disease, illness, and injury. No federal dollars would go to the destruction of embryos, as the stem cell lines are derived privately.
FAQs
What is contained in S.5?
S.5 The Stem Cell Research Enhancement Act
Why are embryonic stem cells so promising?
The Promise of Embryonic Stem Cells
Can’t we use an alternative method that doesn’t destroy the embryo?
Alternatives - No Substitute
Can’t private enterprise do this research? Why do we need the federal government involved?
Why NIH is Best Suited
Want to learn more about stem cell research?
Click here to visit CAMR’s informative online brochure on stem cell research.
|
Powered by Phase2 Technology