The Seven Year Itch: Human Embryonic Stem Cell Policy

1. The Seven Year Itch:Human Embryonic Stem Cell Policy Carrie D. Wolinetz, Ph.D. Federation of American Societies for Experimental Biology (FASEB) SDB Mid-Atlantic Meeting May 14, 2005

2. What’s wrong with this picture? • A son of Republican President Ronald Reagan speaking at the Democratic National Convention B. A science policy issue is being discussed on prime time at the level of Presidential politics

3. First, came the science…. 1998: James Thompson – U of WI John Gearhart – Johns Hopkins Eureka!!! Human Embryonic Stem Cells!! -- Science 282(Nov. 6):1145.;Proceedings of the National Academy of Sciences 95(Nov. 10):13726 (1997: The Sheep Heard Round the World)

4. … but not out of nowhere Scientific breakthroughs are built on years, decades, centuries of fundamental discoveries… MOUSE ESC IVF / EMBRYO RESEARCH ADULT STEM CELLS Eureka!!! Human Embryonic Stem Cells!!

5. Step 2 - Big excitement!!!

6. Next comes the policy debate… • Debate based on ethical issues / concerns • Also 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.” 1979 (1985) - Leon Kass On in vitro fertilization

7. So, what is embryonic stem cell policy? • Federal embryo policy • 1994, Clinton ban on creation • 1996, Dickey amendment, Jay Dickey (R-AR) • Appropriations rider • Forbids funding embryo research • 1999-2000, HHS interpretation, NIH guidelines • January 2001 – Bush review • August 9, 2001 – Presidential policy

8. August 9, 2001, 9:01 PM (EST) Federal funding for existing cell lines A day that shall live in infamy…

9. Um… how many lines did you say there were? Lest they be doomed to repeat it… • On August 9, 2001 – President’s policy considered wonderful, courageous • Credit to conservative politicians, Senator Hatch, Nancy Reagan • Praised by scientific community, patient advocacy groups, stem cells supporters

10. In the meantime, as we try to figure out how many lines we have… Who cares about hESC research & why? • Scientists • Contribute greatly to basic biology • Excellent tools – models for disease, etc. • Therapeutic potential • Principle of science • Ethicists • Where does life begin? • Subsequent technologies • Pro-life community • Embryo destruction

11. Patient Advocates • Add an emotional aspect to the debate • Believe strongly in therapeutic potential • Responsible for public support

12. So… how many hESC lines are there? • August 27, 2001: NIH says there are 64 lines eligible for federal funding • September, 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 lines • November 2001 - 2002: NIH Stem Cell Registry, 78 “eligible” lines

13. Eligible vs. Available • Not all stem cell lines are created equally • Issues with characterization, storage, growth, shipping, patent / IP Other potential issues… • Mouse feeder cells • Passage problems • Genetic diversity • Natural progression, improvements in cell culture

14. A ban by any other name… • hESC research is perfectly legal But… • NIH leader in setting biomedical research agenda • $28 billion • Envy of the world • “Chilling” effect • Waste of money • Duplication of facilities • Private industry

15. 2004: The Perfect Storm • “Leaked” NIH report – only 19 hESC lines available • Mobilization of the advocacy community • Congressional support • Castle-DeGette • Public support • Polling data • Election politics

16. 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!

17. 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. protections • Moderate Republicans #1 Issue • 200 Co-sponsors • Leadership agreed to vote • Lots of unknowns: passage, floor changes, veto??

18. Muddying the waters • SCNT • Dolly rears her ugly head… • Make hESC issue confusing • Brownback / Weldon bill • Ban attached to stem cell bill…?? • Adult stem cells • Forty years of research, plasticity recent • Offered as hESC alternative • Limitations: • Totipotent vs. multipotent • Difficult to isolate • Limited quantities • Advocacy problems • What if you want both?

19. Perceptions, Deceptions & Expectations…Oh My! • In any public debate, important to be accurate • Complex scientific information • Moving target • Some spin allowed… this is Washington! • Both sides in hESC debate guilty of blurring truth - passion • Balancing promises, expectations • Dear Colleagues

20. Future directions… • Recent NAS report – Guidelines for hESC research • More state laws, more international competition • Legislation vs. administration policy • Earmarking? • Big breakthrough??? • Continued debate or next news cycle?

21. 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. FASEB cwolinetz@faseb.org http://www.faseb.org