The Seven Year Itch:The Seven Year Itch:
Human Embryonic Stem Human Embryonic Stem Cell PolicyCell Policy
Carrie D. Wolinetz, Ph.D.Federation of American Societies for Experimental Biology
(FASEB)SDB Mid-Atlantic Meeting
May 14, 2005
What’s wrong with this picture?What’s wrong with this picture?
A. 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
First, came the science….
1998:
James Thompson – U of WI
John Gearhart – Johns Hopkins
Eureka!!! 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 discoveries…
Eureka!!! Human Embryonic Stem Cells!!
MOUSE ESC
ADULT STEM CELLS
IVF / EMBRYO RESEARCH
Step 2 - Big excitement!!!
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.”
- Leon Kass
1979 (1985)
On in vitro fertilization
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
A day that shall live in infamy…
• August 9, 2001, 9:01 PM (EST)
• Federal funding for existing cell lines
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
Um… how many lines did you
say there were?
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
Patient Advocates
• Add an emotional aspect to the debate• Believe strongly in therapeutic potential• Responsible for public support
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
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
A ban by any other name…
• hESC research is perfectly legalBut…
• NIH leader in setting biomedical research agenda– $28 billion – Envy of the world
• “Chilling” effect• Waste of money
– Duplication of facilities
• Private industry
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
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.
protections– Moderate Republicans #1 Issue– 200 Co-sponsors– Leadership agreed to vote– Lots of unknowns: passage, floor changes,
veto??
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?
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
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?
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
[email protected]://www.faseb.org
