The Seven Year Itch:

Human Embryonic Stem Cell PolicyCarrie D. Wolinetz, Ph.D.Federation of American Societies for Experimental Biology (FASEB)SDB Mid-Atlantic MeetingMay 14, 2005

Whats wrong with this picture?A son of Republican President Ronald Reagan speaking at the Democratic National ConventionB. A science policy issue is being discussed on prime time at the level of Presidential politics

First, came the science.1998: James Thompson U of WIJohn Gearhart Johns HopkinsEureka!!! Human Embryonic Stem Cells!!

(1997: The Sheep Heard Round the World) -- Science 282(Nov. 6):1145.; Proceedings of the National Academy of Sciences 95(Nov. 10):13726

but not out of nowhereScientific breakthroughs are built on years, decades, centuries of fundamental discoveriesEureka!!! Human Embryonic Stem Cells!!MOUSE ESCADULT STEM CELLSIVF / EMBRYO RESEARCH

Step 2 - Big excitement!!!

Next comes the policy debateDebate based on ethical issues / concernsAlso not new.

Technological progress can be but one measure of our national health. Far more important is the affection and esteem in which our citizenry holds its laws and institutions. No amount of relieved [suffering] is worth the further disaffection and civil contention that the lifting of the moratorium on federal funding is likely to produce. People opposed to abortion will not tolerate having their tax money spent on scientific research requiring what they regard as at best cruel, at worst murder. A wise secretary of health and human services should take this matter most seriously, and continue to refuse to lift the moratorium. Imprudence in this matter may be the worst sin of all. - Leon Kass1979 (1985)On in vitro fertilization

So, what is embryonic stem cell policy? Federal embryo policy1994, Clinton ban on creation1996, Dickey amendment, Jay Dickey (R-AR)Appropriations riderForbids funding embryo research1999-2000, HHS interpretation, NIH guidelinesJanuary 2001 Bush reviewAugust 9, 2001 Presidential policy

A day that shall live in infamyAugust 9, 2001, 9:01 PM (EST)

Federal funding for existing cell lines

Lest they be doomed to repeat itOn August 9, 2001 Presidents policy considered wonderful, courageousCredit to conservative politicians, Senator Hatch, Nancy ReaganPraised by scientific community, patient advocacy groups, stem cells supporters

In the meantime, as we try to figure out how many lines we haveWho cares about hESC research & why?ScientistsContribute greatly to basic biologyExcellent tools models for disease, etc.Therapeutic potentialPrinciple of science EthicistsWhere does life begin?Subsequent technologiesPro-life communityEmbryo destruction

Patient AdvocatesAdd an emotional aspect to the debateBelieve strongly in therapeutic potentialResponsible for public support

So how many hESC lines are there?August 27, 2001: NIH says there are 64 lines eligible for federal fundingSeptember, 2001: Actually only 24-25 established lines, rest in some stage of derivation Thompson to HELP cmte.September, 2001: NAS report endorsing hESC research funding, more linesNovember 2001 - 2002: NIH Stem Cell Registry, 78 eligible lines

Eligible vs. AvailableNot all stem cell lines are created equallyIssues with characterization, storage, growth, shipping, patent / IPOther potential issuesMouse feeder cellsPassage problemsGenetic diversityNatural progression, improvements in cell culture

A ban by any other namehESC research is perfectly legalBut

NIH leader in setting biomedical research agenda$28 billion Envy of the worldChilling effectWaste of moneyDuplication of facilitiesPrivate industry

2004: The Perfect StormLeaked NIH report only 19 hESC lines availableMobilization of the advocacy communityCongressional supportCastle-DeGettePublic support Polling dataElection politics

When the federal government is away. The States will play!Prop. 71 other states scrambling to catch up

Canada is laughing all the way to the bank world competition!

So, where are we now? Stem Cell Research Enhancement Act of 2005 (H.R. 810 / S.471)Rep. Michael Castle (R-DE) Diana DeGette (D-CO)Expands funding policy, human subj. protectionsModerate Republicans #1 Issue200 Co-sponsorsLeadership agreed to voteLots of unknowns: passage, floor changes, veto??

Muddying the watersSCNTDolly rears her ugly headMake hESC issue confusingBrownback / Weldon bill Ban attached to stem cell bill??

Adult stem cellsForty years of research, plasticity recentOffered as hESC alternativeLimitations:Totipotent vs. multipotentDifficult to isolateLimited quantitiesAdvocacy problems What if you want both?

Perceptions, Deceptions & ExpectationsOh My!In any public debate, important to be accurateComplex scientific informationMoving targetSome spin allowed this is Washington! Both sides in hESC debate guilty of blurring truth - passionBalancing promises, expectationsDear Colleagues

Future directionsRecent NAS report Guidelines for hESC researchMore state laws, more international competitionLegislation vs. administration policyEarmarking? Big breakthrough???Continued debate or next news cycle?

Questions?In Science the credit goes to the man who convinces the world, not to the man to whom the idea first occurred.Sir William Osler (1849-1919) Canadian physician.Carrie D. Wolinetz, Ph.D.FASEBcwolinetz@faseb.orghttp://www.faseb.org