The Seven Year Itch: Human Embryonic Stem Cell Policy

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The Seven Year ItchHuman Embryonic Stem Cell
Policy

• Carrie D. Wolinetz, Ph.D.
• Federation of American Societies for Experimental
  Biology (FASEB)
• SDB Mid-Atlantic Meeting
• May 14, 2005

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Whats 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
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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)
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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!!
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Step 2 - Big excitement!!!
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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
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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

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A day that shall live in infamy

• August 9, 2001, 901 PM (EST)
• Federal funding for existing cell lines

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Lest they be doomed to repeat it

• On August 9, 2001 Presidents policy considered
  wonderful, courageous
• Credit to conservative politicians, Senator
  Hatch, Nancy Reagan
• Praised by scientific community, patient advocacy
  groups, stem cells supporters

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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

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Patient Advocates

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

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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

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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

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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

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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

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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!

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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??

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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?

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Perceptions, Deceptions ExpectationsOh 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

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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?

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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_at_faseb.or
g http//www.faseb.org