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WORLD STEMCELLREPORT2009GENETICSPOLICYINSTITUTE
501c32010 WORLDSTEMCELLSUMMIT•DETROIT, MI•OCTOBER 4-6, 2010WWW.WORLDSTEMCELLSUMMIT.COM• WWW.GENPOL.ORG
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STEM CELLS, REGENERATIVE MEDICINE, ANDSOCIETY 
n March 9, 2009 President Barack Obamasigned an Executive Order expandingfederal funding for research usingembryonic stem cells in a White House signingceremony packed with legislators, scientists, andpeople who have suffered from a range of diseases and medical conditions that couldbenefit from the research. The President’sexecutive order was a major milestone in the 10-year effort by those patients, scientists,academics, and others who have argued insupport of a broader federal stem cell policy.
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In some ways, the most telling aspect of the ceremony was that when President Obama signed the Executive Order, numerousmembers of Congress were in attendance. Their presence signaled asignificant shift in public opinion regarding the use of federal fundingfor embryonic stem cell research; further, it demonstrated theattitudinal changes regarding stem cell science that have taken placesince 1998, when embryonic stem cells were first derived.Today, for many Americans, stem cell science is viewed aspotentially beneficial – not just for people suffering from disease –but in maintaining the country’s prominence and preeminence inscientific leadership. In a remarkably short timeframe, stem cellscience has made the unusual transformation from a non-issue to apolitical hot button – and to an issue that transcends politics.
Background
Embryonic stem cells were first discovered in 1998 by Dr. JamieThomson of the University of Wisconsin and Dr. John Gearhart of the Johns Hopkins University.
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 While widely applauded for itspotential in the scientific community, their discoveries very quickly set off a firestorm affecting researchers, ethicists, politicians and, mostimportantly, patients in the United States (US) and around the world. In fact, the first series of congressional hearings on the sciencefollowed quickly, beginning in January 1999, when the SenateCommittee on Health, Education, Labor, and Pensions convenedsessions involving a series of top researchers and ethicists.
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 What became clear at the outset was that most US policymakersdid not have an understanding of stem cell research and therefore were uncomfortable with the concept. Almost immediately, thesource of embryonic stem cells became a key issue in the discussionand debate and initially there were broad misunderstandings aboutthe origin of stem cells – with many assuming the issue to be
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associated with abortion. At the time, relatively few legislators had a clear understandingof the reality; the stem cells at the center of the issue were cells derivedfrom embryos created for
in vitro
fertilization (IVF) procedures. Infact, the cells in question were not going to be used and were slatedto be discarded.More often than not, the creation of embryonic stem cells waserroneously linked to abortion, and the corresponding political,moral, and religious issues that it entailed. To compound theproblem, there were a handful of legislators and others that mighthave understood that abortion was not tied to stem cells, but did nothave a detailed understanding of or were uncomfortable with the IVFprocess itself. As a result, the immediate political reaction to the 1998Thomson/Gearhart discoveries leaned toward a ban on the research.
The Role of Patient Advocacy
In response to initial fears and negative reactions (often based onmisunderstanding), an organized effort was launched on the part of patient advocacy groups to delay any potential federal ban onembryonic stem cell research. The aim was to provide education onthe role of stem cells, the science, and their potential for therapies andcures for leading conditions. In addition, time was needed to enablediscussion and debate related to surrounding ethical and religiousimplications. This effort started with Patient’s Cure, originally formedby Dan Perry, who was the Executive Director of the Alliance for Aging Research. Patient’s Cure’s major focus was to slow themomentum of any amendments that might surface in Congressrestricting federal funding and support for stem cell research.Patient advocacy in the area of stem cell research emerged amongthe campaign promises made by then Presidential candidate George W. Bush, who pledged to impose a ban on federal funding forembryonic stem cell research. Once elected, it was clear that a largerscale and more comprehensive effort would be required to preservefederal funding for the research – if not the ability to conduct stemcell research itself.
Formation of the Coalition for theAdvancement of Medical Research (CAMR)
The result was the creation of the Coalition for the Advancement of Medical Research (CAMR). Today, CAMR comprises more than 100 nationally recognized patient organizations,universities, scientific societies, and foundations, and conductsadvocacy and education outreach focused on developing bettertreatments and cures for people with life-threatening illnesses anddisorders.
Federal Funding of Stem CellResearch: Past, Present and Future
By Lawrence A. Soler, J.D.
 
WORLD STEMCELLREPORT2009GENETICSPOLICYINSTITUTE
501c32010 WORLDSTEMCELLSUMMIT•DETROIT, MI•OCTOBER 4-6, 2010WWW.WORLDSTEMCELLSUMMIT.COM• WWW.GENPOL.ORG
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actually usable for research, because they didn’t exist or had othertechnical problems. The result was that scientific progress wasdelayed. With a President opposed to expanding funding for stem cellresearch and a Congress increasingly supportive, the remaining yearsof the two terms of the Bush presidency were essentially seven yearsof stalemate. The science became an issue in the 2004 Presidentialelection – but with the re-election of President Bush, there was nomovement in either direction. But as a result of continued advocacy activities by the research community, CAMR, and others, Congresstwice introduced legislation and passed bills, with strong support,that would overturn the 2001 policy and expand the fundingavailable for embryonic stem cell research. Twice, however, these bills were vetoed by the President, which Congress was unable to overridebecause it lacked the two-thirds vote to do so. Progress in stem cellresearch was increasingly limited as federal support became moretechnologically slowed.
Recent Policy Changes and Claims to Pavethe Way for Stem Cell Research
The issue again bubbled to the top of the political consciousnessduring the 2008 Presidential campaign, but with little of theprominence or vehemence that had typified previous politicaloutbreaks – owing in large part to stem cells no longer being thepolarizing political issue that they had been earlier in the decade.Candidate Barack Obama noted early and often in his campaign thatamong his first acts, if elected, would be to expand federal funding forembryonic stem cell science. Senator McCain also was on record insupport of the research.Candidate Obama became President Obama, and true to his word, acted to get the research back on track, with his historicExecutive Order, which brings us full circle to the beginning of thisarticle.
Current Policy Changes and Controversies:Questions for Consideration
But does President Obama’s March Executive Order signal thatthe public policy controversies surrounding embryonic stem cellresearch are over, once and for all?Perhaps. But perhaps not.In July 2009, the National Institutes of Health issued its finalguidelines governing federal funding for embryonic stem cellresearch, after a 90 day public comment period on its initialguidelines. JDRF and others in the research community haveapplauded the guidelines, particularly for including a provision under which existing stem cell lines derived in an ethically-responsiblemanner would be eligible for federally funded research. Thisprovision will ensure that a process is in place so researchers can buildon the stem cell advancements made to date and accelerate researchon cell lines with the greatest potential to facilitate treatment of thedisease.So where does that leave us? After 10 years of uncertainty, thescientific community finally has clear direction and support for asubstantially expanded platform for embryonic stem cell research.In 2001, Tim Leshan of the American Society for Cell Biology and I created CAMR to bring together patients, scientists, academia,industry and others to pool resources and build public support forembryonic stem cell research. Building on the efforts of Patient’sCure, CAMR provided a voice for the widespread interests that saw the potential of embryonic stem cells to better understand a range of diseases, from diabetes to spinal cord injuries, and perhaps even oneday create therapies to alleviate their suffering. Most important,CAMR provided a rallying point for not only people impacted by diseases that stem cells could possibly help, but for the medicalresearch community, which – understandably, given that it was sonew – did not have a unified voice
vis a vis 
stem cell research at thetime.During the initial months, CAMR operated with frantic effort.First and foremost, its advocacy activities focused on attempting tomake it difficult for the Administration to quickly implement anexecutive order that would simply stop embryonic stem cell research– a quite likely outcome at the time. These efforts were combined with a larger strategy to educate policymakers and the Americanpeople about embryonic stem cell research, with a particular focus onthe relationship between stem cell research and IVF, and the fact thatstem cell research is not related to the abortion issue but moreanalogous to organ donation. As expected, scientific journals and research publications focusedintently on stem cells. But in just a few short months, stem cellsbecame one of the top general media issues as well. The issue wasfeatured regularly on the front pages of the nation’s largestnewspapers, and was a regular topic on cable television news andopinion programming. And the just-exploding blogosphere took upthe call, and stem cells were a regular topic for political and news-related websites. As more was explained about the research – what it was, and particularly, what it was not – support for it and oppositionto the President’s potential banning of funding for the researchgradually began to grow.Transparency around the issue, as it turned out, mattered.Ultimately, President Bush, in his first nationally televised address tothe nation, did not ban embryonic stem cell research or federalfunding for it; drawing a political, rather than a scientific, distinction,he allowed limited funding for embryonic stem cell science – just forthose stem cell lines that had been created prior to his address on August 9, 2001. Any chance of changing the policy ended onSeptember 11, 2001. The front page of the New York Times on thatday included a story on stem cell research policy, but given the eventsof that day, the issue was driven from the headlines – for a while. While seen by many at the time as the best possible outcomegiven the circumstances, the President’s decision unfortunately created an extended holding pattern for embryonic stem cell research. While not restricting its expansion, per se, limiting federal funding tothe lines existing before August 9, 2001 made it significantly moredifficult for stem cell research to expand at the rate one might haveexpected, given the promise of the science. Within a matter of years,it became clear that the stem cell lines actually available for federalfunding were far fewer than those that were meant to be included. Asit turns out, only 21 of the approximately 70 lines that were initially promised by the Administration for federal research dollars were
STEM CELLS, REGENERATIVE MEDICINE, ANDSOCIETY 
 
WORLD STEMCELLREPORT2009GENETICSPOLICYINSTITUTE
501c32010 WORLDSTEMCELLSUMMIT•DETROIT, MI•OCTOBER 4-6, 2010WWW.WORLDSTEMCELLSUMMIT.COM• WWW.GENPOL.ORG
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Necessary “Next Steps”
 As positive as the Executive Order is for moving stem cellresearch forward, the possibility always exists that it could beoverturned by a future president who opposes the science. Anotherpresident could simply issue a new Executive Order that returns tothe Bush Administration restrictions – or worse. As such, a critical next step is to pass legislation in both theHouse and Senate, codifying federal funding for stem cell researchthat can be signed by President Obama. Such legislation would makeit extremely difficult for research to be stopped by a future president.In fact, once legislation is approved, the only way a future Administration could reverse it would be for a new law to be passedthrough the House and Senate and signed by the President. Given thestrong public support that has grown for embryonic stem cell researchover the years, that seems extremely unlikely.Based on the previous two bills that were introduced during thepast decade, there would most likely be enough votes to approve a billfunding this research. But the legislative process includes pitfalls thatalways need to be considered, such as anti-research amendments thatcould be proposed that may not be adequately explained in acongressional debate and could lead to limitations on other types of research.
Conclusion
Moving forward, it remains important for patients, scientists,universities, physicians, and others to continue to build supportamong policymakers so that an embryonic stem cell bill can bepassed.Since the discovery of embryonic stem cells a little more than adecade ago, we have seen dramatic shifts in public perception of andpolitical support for the research. Clearly, both are at a high pointtoday. But now and throughout the darkest days of the past decade,there has been a constant – the people with diseases that might oneday benefit from this science. Our focus should be on them – and onmoving this science forward quickly, effectively, and ethically.That is undeniably positive for researchers and patients alike. Butthere will still be some limitations. For example, the President’sexecutive order and the NIH guidelines do not include researchinvolving stem cells created through somatic cell nuclear transfer(SCNT) or parthenogenesis – alternatives to the “traditional” methodof creating embryonic stem cells that could potentially speed theprogress of utilizing these cells for research or replacement purposes.Today the advantages of where the scientific community standssurely outweigh the disadvantages of the past. In fact, compared with just a few years ago, there are a number of advantages in movingforward, both scientific and attitudinal. For example, researcherstoday have the freedom to effectively work on many additional stemcell lines, this creates cost efficiencies, opening the door for disease-specific science, and encouraging collaboration among researchersfrom different organizations, with different backgrounds, and withdifferent aims. All this is a major step forward for research incombating a wide range of diseases and medical issues. Just as important, a more transparent and positive policy towardsfederal funding for stem cell research means that young scientists willnow begin to see a future in the field, and add to the talent pool of researchers working towards cures and treatments. Before, withlimited federal support and the constant threat of a possible overallban on stem cell research, only the most optimistic young scientists would have considered stem cell research as a growth industry. Theincreased talent devoted to the field will, undoubtedly, have amultiplier effect on the pace of progress in stem cells in the near andlonger-term future.That impact will be felt on the institutional level, as well. Untilnow, more than a few universities have been very conservative indetermining whether to allow private embryonic stem cell research –science using non-federally approved stem cell lines – to beconducted in university buildings that receive federal indirect costsreimbursement. The fear was that given the intricate accounting andprocedural issues surrounding research funding, non-approvedresearch conducted in buildings supported by federal funds, even if the accounting was done exactly right, could in some way jeopardizethe university’s federal funding eligibility. The broadening of thepolicy should substantially alleviate many of these concerns. But weare not done yet.
STEM CELLS, REGENERATIVE MEDICINE, ANDSOCIETY 
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