By M. Paul Raj Shekar
Stem Cell Research is always interesting and challenging to the scholars. The healthcare professionals, basic science researchers and the administrations across the globe have been struggling to cope up with the newly emerging diseases and the lack of medical solutions to many existing life threatening diseases like Heart vessel blocks, Diabetes, Brain hemorrhage, neurological disorders, spinal cord injury, kidney ailments and many degenerative conditions like Alzheimer’s disease or Motor Neuron disease. The governments are spending millions of dollars on the healthcare cover and facilities to its citizens, with no or least scope for improvement in controlling the diseases. The pharmaceutical industry, research laboratories and medical associations are involved in massive scientificactivit ir T better treatment options, mi ‘non tment solutions and in case of surge, to asi surgical procedures, to treat patients. ear activity on Stem Cells has goir ce §970 but primarily by using adult stefi cell ymal stem cells, skin stem cells, Umbilical cord stem cells etc. However the embryonic stem cellsy whi art completely a different from the addit stem cells ha: been actively pursued in the last two decades, but had only a minimal success. It is presumed that the embryonic stem cells, if/siccessfully created and cultured in artificial mediums outside the woman’’s womb, in a laboratory, could be used to create any kind of body tissues or organs, which might be used to regenerate the damaged organs in a human body. For example in a Parkinson’s disease patient, who has a degenerative nerve cells, the laboratory cultured stem cells could be implanted which might acclimatize to the host start dlconverting itself in to nerve cells, there by offering better life to the patient. At this M point the natural 1998 – 2012 h‘!’/ il question will be about the source of embryo’s for the research which offers promising possibilities in treatment of various life threatening ailments. The embryo’s are the outcome of the fertilization of a sperm with a ovum or egg of the female inside her body, which eventually grow in to a fetus inside the womb and born as a baby after 36 weeks. Therefore the very first seed cell is called the embryo with which all humans are made. Many times the prospective parents have medical challenges in achieving pregnancy and in the process opt for artificial fertilization in the IVF clinics where the sperm and the egg are fertilized in a petri dish. The professionals often create more than a dozen embryo’s out of which only a few are implanted inside the mother’s womb to initiate pregnancy. The surplus embryos created in those labs are frozen and kept in storage for future use of the couple or used for embryonic stem cell research with the consent of the couple. These embryos contain 4-5 day old blastomeres called embryonic stem cells, which have the ability to differentiate itself in to any type of future cell or tissue. These amazing embryonic stem cells offer possible treatment solution to many chronic and life threatening diseases, but are not yet proved i f successfully cultured in the laboratory, stem cells can be implanted to the patients i heart disease, diabetes, blems, Spinal cord injury, Cancer treatment, blood questio the stem cells, g to the Christian religious conservatives and prolife supporters, amounts to killing of a life. They oppose any research activity involving destruction of any cells that, even if it is one day old, it has life and destruction amounts to murder. In USA, ever since Prof James Thomson first created the embryonic stem cell lines during November 1998and President Clinton favorably considered funding the future research; this issue becomes a sensitive domestic issue involving Christian groups opposing the funding on one LAwWZ £39% A lili i side and the scientist, patients and public on the other side. The process of obtaining the live blastocyst by opening the embryo results in the ultimate destruction of the embryo, which is strongly considered by the ethicist and religious leaders as killing of a life to create a new cell line. The moral question is about the actual destruction of this embryo which could have been a prospective life in future, had it been adopted by prospective parents to have child. The religious perspective is that the life starts at the moment when a sperm and egg are in contact and united to become a zygote or an embryo. The religious leaders do not accept the suggestions that these are not the humans or foetus as they do not have multi organs and the embryos formed outside the mother’s womb as embryo. For them it is just a des promote or facilitate a research stud experts feel that any innovative out to make and the process of opening e harvest blastocysts not necessarily b destruction but creation of potential ne will offer unimaginable medical benefits patients. They view the ex-vivo fertiliz: embryo, ex-vivo harvesting of blast may not be considered as destructic f over they feel that the embryo below not actually a capable life and the el study are availed from the excess sto i i clinics with the consent of the donors. When President Bush took over in 2001, the first major domestic policy announcement from him was about the suspension of the funding for the research. The Bush administration during the year 2001 came out with a dual strategy to handle the policy situation, possibly trying to satisfy both sides of the warring groups. The Bush policy suspended any kind of federal fundssing to the embryonic stem cell research since 2001, but never banned the research completely in USA, keeping the possibility of private funding in the research. Also President Bush permitted a small funding for around 60 stem cell lines, which were already created by researchers, before he became the President, thereby expressing his cosmetic support to the scientific community. The stem cell policy issue in US became a major domestic problem with scientists, publics, patient groups asking for federal fundssing on one side and the Catholic and Conservative Christian groups supported by prolife groups opposing any kind of research, from 2001 till 2007. The campaign by both the sides with many debates, Senate hearings and lobbying lead to Congress passing legislations during 2006 and 2007 were promptly rejected by President Bush using his Veto Power. The Catholic Church took the lead in vehemently opposing the embryonic stem cell research right from the beginning.
Some of the individual Christian leaders who vehemently opposed the embryonic stem cell research are Richard Doerflinger of US Conference of Catholic Bishops, Father Ted Pacholczyk of Nation Catholic Bioethics Centre, Beverly LaHaye of Concerned Women of America, Paul Schenck of National prolife Action Centre and John Danforth a Episcopal Minister from Missouri.The usc United States Catholic Church Bishops the leader in the group opposing the This organization had consistently with pastoral letters, release of Senate and house members of ‘the President and White House n in TV Debates and conducting the believing Christians. This made public opinion and great awareness he Americas leading scientific led for a determined, coherent and ‘stem cell research policy with from the federal government. The ons like National Academy of 1ces, the American Association for Advancement Science, the International Federation for Advancement of Cell Biology, the American Society for Cell Biologists, Union of Concerned Scientists were in one voice in supporting the enhancement of the research in USA. The other medical research foundations like Cystic Fibrosis Foundation, St Jude’s Medical Center, Juvenile Diabetes Research Foundation, the Christopher Reeve Paralysis Foundation and Michael J Fox Foundation for Parkinson’s Research, Sickle Cell research Foundation, the Elizabeth Glaser Pediatric AIDS Foundation, ALS Therapy Development Foundation, National Coalition for Cancer Research, Parkinson’s Action Network and American Nurses Association of California have also expressed their strong support and outlined the urgent need to support the embryonic stem cell research. Some of the scientists who individually contributed to embryonic stem cell research are James Thompson, Wisconsin, Chicago, Doug Melton, Harvard University who aggressively pursued the hESC research. The public and celebrities who supported and made a big New Methodlogy difference in the embryonic stem cell research campaign are Mrs Nancy Reagan and Family, Mary Tyler Moore, Superman Christopher Reeve, Michael J Fox, Robin Williams, Paul Newman, Ted Danson, Glenn Close, Meryl Streep, Mandy Patinkin, John Lithgow, Jane Seymour, Margot Kidder, Kevin Costner and many others. The patient and public formed an umbrella organization called Coalition for Advancement of Medical Research, under which all Scientists, Students, Universities, Public, Civil Society, Legal and many patients groups have joined. Larry Soler was the leader of the Coalition for Advancement of Medical research who is originally from the Juvenile Diabetes Research Foundation took the role of the chief advocate of the supporting public and patients. Their campaign activities included the debates, letters to lawmakers, mass email communication campaign to general public, articles in social media, personal appearance in Congress Senate and house hearing to impress on the Congress members to vote for a favorable legislation. Path breaking innovation in hESC Research by James Thomson and its Global Impact
Pushing the frontiers of biology possibly to the next higher level, scientists have for the first time during 1998, picked and cultivated the primordial human cells from which an entire individual could possibly be created. Two forms of human embryonic cells have been developed; one by a team under Dr. James A. Thomson of the University of Wisconsin in Madison, the other by Dr. John Gearhart and colleagues at the Johns Hopkins University School of Medicine in Baltimore. Dr. James Thomson’s work was reported in Journal Science during the 1% week of November 1998 (Thomson JA, Science, 1998). Dr. James Thomson grew his embryonic stem cells from the inner cell mass of blastocysts that had been left over from fertility treatments and were to be discarded. The donors of the blastocysts granted permission for them to be used in research. The research in embryonic stem cell has been going on in countries like United Kingdom, Germany, Australia, Korea and Singapore for many years but the real breakthrough came from USA which is considered as the leader in scientific innovations due to its sheer focus on inventions and the huge investments made on various research projects. The concept of cloning was first done by the British scientists in the sheep Dolly which opened up the possibility of embryonic stem cell research all over the world in a big way. Among the many countries, British and Singapore governments have made great progress in stem cell research and created a meaningful guidelines and oversight for the institutions involved in this activity. The invention by Prof James Thomson in November 1998 led to many countries setting up their own expert groups and scientific panels by their respective governments. Fortunately the religious, moral and ethical issues were comparatively minimal in case of all other countries compared to USA. The countries like China, Brazil, South Africa and India where the population is very high with huge healthcare issues have opened up the research and emphasized the need for quicker outcome whereas countries with Catholic and religious Christian groups were cautious in their response.
Undoubtedly America is leading the world in Science and Technology as well as path breaking innovations. The leadership vision, their historical innovative achievements and the sheer money power propel USA to focus more on new technology and invent new ideas. The major reason for America’s success in innovation is due to their federal fundssing and support for any new
Any successful invention comes with lot of hard work and years of pains taking efforts, but the outcome porting the program larger inter of the nation and the health of if citizen, without compromising the basic principl and the ideology of the nation research, without which big ideas cannot be converted in to a meaningful outcome. America’s focus is always on improving healthcare, clean energy, power generation, education, space technology and agriculture. The American government spends more funds for research and development than any country in the world. The President’s 2015 budget has $135.4 billion allocated for federal R&D in which $ 64.7 for basic science research, $7.3 for National Science Foundation, $ 5.1for Energy research and $ 30.2 billion for National Institute of Health which funds all medical research activities in USA.America has shown the world the path of successful research in last two centuries and had some greatest scientists such as Benjamin Frankliin, Thomas Jefferson, Graham Bell, David Rittenhouse, Albert Einstein, Robert Fulton, Samuel Morse and Thomas Alva Edison to name a few.
Affirmative US Policy on funding of hESC Research during Bill Clinton Administration
President Bill Clinton followed a democratic way of ultimate decision-making process as model in which he involved every stakeholders and interest groups who can make value addition to his decision for the sake of nation building. Especially when the issue is related to domestic affairs and affecting the public directly, he was very conscious about the possible outcome and involved many advisors, experts, officials of White House, public opinion and many times involved Vice President Al Gore and First Lady Hillary Clinton for their suggestions. The embryonic stem cell research was one of the strong domestic issues he faced towards the end of his presidency, which involved moral and ethical issues with views expressed strongly from both supporters and opponents of the research. The First Lady Hillary Clinton is a committed Christian and a member of United Methodist Church with Rev Edward Matthews, as leader of United Methodist Church. Al Gore, Vice President and Donna Shalala, Secretary of Department of HHS of Bill Clinton administration from 1993 — 2001 are other strong supporters and advisors of President Bill Clinton in his healthcare initiatives, policies and especially his decision to support the funding of embryonic stem cell research during 1999. Leon Panetta served as the Clinton white house Chief of Staff from 1994-1997also involved in the earlier administrations decision on stem cell research. Bill Clinton’s administration had a policy of “Complete Ban” on any research involving human cells since 1993 to 1998. President Clinton even signed a legislation called Dicky-Wicker Amendment, during 1995, which bans stem cell research. The discussions about the handling of future embryonic stem cell research started the very next days of the creation of the new stem cell lines by Prof James Thomson during the first week of November 1998. The second week saw hectic consultations, preparations of white papers and lobbying by different groups happened at the Congress’s Senate and House committee offices, the Department of HHS, NIH and NBAC and at the Domestic policy council at White House. The scientists groups, patient associations, public civil society representatives and the biotechnology industry lobbying for the approval and funding of embryonic stem cell research that were strongly supported by the NBAC and NIH officials. The religious conservatives and prolife groups also started their pressure to advice the government not to approve or fund this immoral research by destroying the embryos, through the republican senators and representatives at the Congress. On 30″ November ill 4″ December, 1998 the Senate Committee on hedith sat for a hearing on whether to support the federal fundssing to stem cell research chaired by Senator Arlen Spector, R-PA and Senator Tom Harkin, D-IA, Ranking Democrat. The NIH Director Harold Varmus presented the case in favor of funding the research. There were hectic consultations and lobbying happened between various departments like, Congress, DPC, OMB, HHS, NIH and the NBAC during November 1998 till June 1999. Clifford Gabriel, of the Office of Science and Technology Policy, wrote a letter on 17″ November 1998 to DPC and the Legal Counsel that the NIH Director along with the NBAC Chair will present and depose in the Senate hearing during the 1 week of December 1998. John Podesta, Chief-of-Staff in President Clintons second administration was another supporter of the stem cell research funding was actively facilitating the discussions between various agencies and the White House advisors. Jerold Mande, Deputy Under Secretary, Food safety worked very closely with the DPC and HHS in supporting the administration’s decision on funding the stem cell research.On 11 February, 1999 many republican Congress members oppose funding plan of administration in a letter to HHS secretary Donna Shalala referring to the Congressional ban on any kind of funding passed during 1995 – 1996. Harriet Rabb, top Legal Counsel on Healthcare in the DPC gave her recommendations to fund stem cell research, on 15″January 1999. She gave a different perspective to the legality by observing that the Congressional ban is on the destruction of the embryo and not on the stem cell lines itself. Therefore if the embryo breaking is done with private funding the state have no legal constraints in funding the research of stem cell lines which are already created. Chris Jennings whoserved in the White House as Senior Health Care Advisor to President Clinton at the Domestic Policy and National Economic Councils from 1994 to 2001, Harold Shapiro, Chairman of NBAC during Clinton Administration, Bruce Reed, Director of DPC, Elena Kagan, Deputy Director of DPC during 1997-1999, Devorah Adler, Assistant Director on Health Policy were the other active members of President Bill Clinton’s team which took the decision on funding the stem cell lines research. NIH Director Dr. Harold Varmus announced that the President Clinton administration’s decision to fund stem cell research on 19″ January 1999. As can be seen in this section, President Bill Clinton’s favorable decision on funding the Stem Cell research was done with extensive consultations and discussions and technical inputs from experts starting from Vice President Al Gore, Chief of Staff, HHS Secretary, Director of DPC, Director of NIH, NBAC Chair, OSTP, OMB and the Legal Counsel of White House along with many experts from the Universities.
Curtailing of Federal Funding for hESC Research during George W Bush Administration
The embryonic stem cell research policy was the first major domestic decision for the President and he wanted to make full use of it to inform the American people his wish and desire for this nation on which pathway is shown by the Lord God. President Bush used this opportunity to place on record his prescription of family values, respect for embryos, dignity for life and the strong relevance of accepting God in everyone’s life through prayers. President Bush announced the suspension of federal fundssing for hESC Research on 9th August 2001. His decision to curtail the federal fundssing is purely based on his personal religious beliefs, conviction to moral values, and his strong belief that one should not cross the moral and ethical line by killing the embryos. He made it very clear that as President he spent considerable time in studying the policy and after careful deliberations he had come to a decision, which is good for the people and the country and its moral values. He further said that anyone trying to push further any legislation to derail his policy will be vetoed, and actually he did veto, a first of his Presidency, in 2006 and again in 2007, when the Congress sent the revised legislation for his approval. In case of President Bush he was absolutely consistent in his policy views on embryonic stem cell research wherein he maintained his moral and conservative stand all along his presidency, which saw a setback for the promising research. President Bush was confronted by lawmakers, patient groups, celebnly powar, public crmclsm, nat during _hi;xs e role irector and is & col uw party member, in shaping the 2001 policy of Preside! Bush in the announcement to curtail the federal fundssing for the embryonic stem cell research. The other following Directors and members of the DPC were, Karl Zinsmeister, Philo D. Hall, Ryan Bounds, Susan Buckland, Karl Rove, Diana L. Schacht to name a few who were active part of the embryonic stem cell research policy discussions and decisions of President Bush during 2004-2008. The DPC worked very closely with Department of HHS and other agencies like NBAC, NIH, OMB and the Legal Counsel to stand firm on their policy of not using the federal fundss for the stem cell research till the end of 2007. Many Congress members had switched their sides and loyalty over the period and passed legislation successfully with two third majority and sent to the President Bush for his approval, not just once but twice during 2006 and 2007. The many number of Congressional hearings, appearance of experts, public campaigning, views from the NBAC and DPC were primarily the expression of pressure from the conservative and prolife groups which suited the President’s almost previously made decision on the subject. The Republican Party being the Grand Old Party in American democracy has been a strong advocate of moral and prolife values of its nation. The party derives support and great resources primarily from the conservative Christians who are their long time and strong vote base for many decades. But actually the republican members and white house top aides of President Bush like Karl Rove, Karen Hugh, Jay Lefkowitz, Secretary Tommy Thompson and even Vice President Dick Cheney were influential in the presidential decision making process on embryonic stem cell research. Vice President Dick Cheney, Karl Rove and Jay Lefkowitz were actively involved in the discussion process with the groups and the President. Though Dick Cheney and Jay Lefkowitz were neutral and listen to the argumenls by the supporters of stem advocated against any n the research. Therefore ‘given mg-b ckarou %any support to embryonic h will c inly going to hurt the hich will cost the White Karl Rove was one of ident Bush’s policy of unding.But the final views ision was probably taken strong personal religious efs bas ‘Q‘s Sidential Pre-eminence decision- making m% e knows that the supporters of & :ss aich ‘:a valid point and the ss*of ssil ent outcome will benefit people, he was not happy with just that, as his moral thinking was above than any scientific and technical arguments. The circumstances and the timelines surrounding the President’s decision on stem cell research by quicker announcement within weeks of assuming the office, the infamous vetoes he applied for rejecting the Congress legislations clearly show how strong he felt on this issue and the Pre-eminence decision he took on embryonic stem cell research policy.
Policy Reversal by supporting hESC Research by Barack Obama Administration
On March 9, 2009, President Barack Obama issued an Executive Order lifting restrictions on the federal fundssing of human embryonic stem cell research that had been in place since August 9, 2001, when President Bush announced a policy that federal fundsss could not be used to support research using human embryonic stem cells lines.The Obama Executive Order directed the National Institutes of Health to issue Guidelines to permit such funding. The NIH finalized its stem cell Guidelines on July 7, 2009. The NIH Human Embryonic Stem Cell Registry lists more than 100 human embryonic stem cell lines that meet the eligibility criteria set by NIH under the Obama policy. The criteria require that the hESC line, 1) Was created using in vitro fertilization for reproductive purposes and were no /36 FEBRUARY 2015 longer needed for this purpose and 2) Was donated by individuals who sought reproductive treatment and who gave voluntary written consent for the human embryos to be used for research purposes.The NIH also set stringent documentation and review requirements.
Role of Judiciary in hESC Research Policy in US
After the NIH Guidelines were in place during 2009, James L. Sherley, M.D., Ph.D., of Boston Biomedical Research Institute and Theresa Deisher, Ph.D., of Ave MariaBiotechnology Company, filed suit in federal court challenging the Guidelines and the federal fundssing of hESC research. The plaintiffs alleged that the Guidelines violate the Dickey-Wicker provision that has appeared in every Labor-HHS appropriations bill since 1996. That provision prohibits federal fundssing for research in which embryos are created for research purposes, or in which human embryos are destroyed, discarded or subject to risk.On August 23, 2010, U.S. Federal District Court Judge Royce C. Lamberth issued a temporary restraining order immediately prohibiting the NIH from further funding human embryonic stem cell research. Judge Lamberth’s order came after a Federal Appeals Court decision giving Sherley and Deisher standing to bring their suit. The U.S. Court of Appeals for the D.C. Circuit stayed the preliminary injunction pending appeal and on April 29, 2011, a split three-judge panel lifted the preliminary injunction. The majority opinion concluded that the opponents of hESCare unlikely to prevail because Dickey-Wicker amendments are ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used. Federal District Court Judge Royce Lamberth on July 27, 2011, rejected the claims of the plaintiffs and dismissed their suit. Judge Lamberth’s decision closely tracked the decision of the U.S. Court of Appeals panel that ruled on the appeal of his preliminary injunction. During January 2013 the US Supreme Court ruled in favor of funding Embryonic Stem Research and the NIH funding of hESC research continues, giving relief to the supporters of the research.
Current Status of hESC Research around the world
The impact of stem cell research policy controversy in US was evident which resulted in slowing down of research work by American scientists during 2001 — 2008. On the other hand the global participation in the embryonic stem cell research was very aggressive with countries like Britain, Sweden, China, Singapore, Australia, Spain, Korea and Japan spent billions in to the research. The research has seen a significant forward movement with USFDA giving approval for clinical trials during 2010 and many countries reporting positive feedback about the research activity. There were approximate 1700 research publications on embryonic stem cell research during 2008 — 2012, which is growing more in number. – The ethical controversy in America gave a chance for other nations to aggressively pursue and possibly overtake US in this field, which also made them to consider the deep ethical issues underlying the research to make appropriate guidelines and law. For example in Singapore during early 2000 the government solicited the opinion of all religious groups for their views on embryo research but formulated a workable guidelines which are transparent, efficient and stringent as well, to deal with any ethical issues.
Conclusion
In this modern era of science and technology moving forward in a greater speed, it is important for the policy makers to understand the significance and go by its pace. Any successful invention comes with lot of hard work and years of pains taking efforts, but the outcome also depends on the state policy and the support of the government of the day. The lawmakers have the responsibility of identifying the need and supporting the programs in the larger interest of the nation and the health of its citizen, without compromising the basic principles and the ideology of the nation. A path breaking scientific research like embryonic stem cell research might or might not provide the results in the near future and nobody can presume the possible final outcome, but it should not be curtailed due to ideology or politics in policy making. The scientific advancements and the human way of life should walk together and possibly complement each other and not compete. Even though the ethics and morality in research need to be preserved by programming enough safe guards, it should not be used to with hold the progress in any area of science. The religious and ethical controversy that created a major domestic policy issue in USA had certainly slowed the pace of the human embryonic stem cell research, as without the state funding and approval, such a major research activity cannot make in to a successful progress. America has been the leading nation in any scientific research but the contradicting policy decisions by the successive administrations made the stem cell research progress very slow. Whereas the positive outcomes of this controversy is that a greater level of awareness was created among the lawmakers, public and nations across the world pushing them to formulate meaningful guidelines and the greater progress of Adult Stem Cell research. Even recentlyon 12″ September 2014, researchers in Japan have reported the first successful implantation of iPS Stem Cells in humans using retinal sheet generated from iPS Cells, in a 70year old patient. The scope for the embryonic stem cell research is immense and aggressive activity is going on in this field across the world.
– M. Paul Raj Shekar, Research Scholar, SIS Jawaharlal Nehru University, New Delhi