Constitutional objections to some of
the Institute of Medicine's sweeping recommendations for changes at
the $3 billion California stem cell agency amount to little more than
a straw man, at least based on a legal memo produced earlier by the
agency.
The legal objections to structural reforms at the
agency were initially advanced in 2009 when the stem cell agency was
fighting an unwelcome analysis of its activities by the state's good
government agency, the Little Hoover Commission. The objections were
voiced again at a meeting earlier this month by some governing board
members, particularly Sherry Lansing, who is also chairwoman of the
University of California regents. Her comments came within minutes of
the start of the Institute of Medicine's (IOM) presentation to the
board.
agency were initially advanced in 2009 when the stem cell agency was
fighting an unwelcome analysis of its activities by the state's good
government agency, the Little Hoover Commission. The objections were
voiced again at a meeting earlier this month by some governing board
members, particularly Sherry Lansing, who is also chairwoman of the
University of California regents. Her comments came within minutes of
the start of the Institute of Medicine's (IOM) presentation to the
board.
She said directors' hands “are tied”
because of requirements in Proposition 71, the ballot initiative that
created the stem cell agency, which is formally known as the
California Institute for Regenerative Medicine(CIRM). While Lansing
did not elaborate, some of the initiative is written into the state
constitution, which can only be amended by a vote of the people.
However, Proposition 71 can also be amended by a 70 percent vote of
each house of the Legislature and the signature of the governor,
which is no small task to achieve.
because of requirements in Proposition 71, the ballot initiative that
created the stem cell agency, which is formally known as the
California Institute for Regenerative Medicine(CIRM). While Lansing
did not elaborate, some of the initiative is written into the state
constitution, which can only be amended by a vote of the people.
However, Proposition 71 can also be amended by a 70 percent vote of
each house of the Legislature and the signature of the governor,
which is no small task to achieve.
The 2009 legal memo (see the full text
below) dealt with the recommendations of the Little Hoover
Commission, some of which were cited and echoed by the IOM. The legal
memo contended that the legislature was barred from making major
changes in the structure of the stem cell agency governing board
because the changes supposedly would not “enhance the ability of
the (agency) to further the purposes of the grant and loan programs.”
The argument was that only the people could make “non-enhancing”
changes. The vague “enhancement” requirement was written into
Proposition 71 by its authors, one of whom is James Harrison, the
outside counsel to the board, who was also the lead author on the
2009 memo. Harrison is revisiting the supposed constitutional issues in the wake of the IOM study.
below) dealt with the recommendations of the Little Hoover
Commission, some of which were cited and echoed by the IOM. The legal
memo contended that the legislature was barred from making major
changes in the structure of the stem cell agency governing board
because the changes supposedly would not “enhance the ability of
the (agency) to further the purposes of the grant and loan programs.”
The argument was that only the people could make “non-enhancing”
changes. The vague “enhancement” requirement was written into
Proposition 71 by its authors, one of whom is James Harrison, the
outside counsel to the board, who was also the lead author on the
2009 memo. Harrison is revisiting the supposed constitutional issues in the wake of the IOM study.
However, the objections cited in his earlier memo are dubious and easily overcome. The meaning of “enhance” is
so vague as to permit wide interpretations. Certainly, removing
public suspicion about conflicts of interest would seem to help move
the agency forward. Straightening out the muddled management
structure of the agency, with its overlapping responsibilities for
the chairman and president, would certainly seem to enhance the
functioning of the agency. Assuring that the governing board has the
full ability to exercise strong oversight over the conduct of the
agency would certainly seem to be an enhancement and long overdue.
so vague as to permit wide interpretations. Certainly, removing
public suspicion about conflicts of interest would seem to help move
the agency forward. Straightening out the muddled management
structure of the agency, with its overlapping responsibilities for
the chairman and president, would certainly seem to enhance the
functioning of the agency. Assuring that the governing board has the
full ability to exercise strong oversight over the conduct of the
agency would certainly seem to be an enhancement and long overdue.
At least that is what the most
prestigious body of its sort says. The Institute of Medicine studied
the agency for 17 months under a $700,000 contract with CIRM. The
IOM's charge was to evaluate the performance of the agency and make
recommendations for improvements. The IOM recommendations echoed
findings not only of the Little Hoover Commission, but some in two
earlier studies also funded by the agency.
prestigious body of its sort says. The Institute of Medicine studied
the agency for 17 months under a $700,000 contract with CIRM. The
IOM's charge was to evaluate the performance of the agency and make
recommendations for improvements. The IOM recommendations echoed
findings not only of the Little Hoover Commission, but some in two
earlier studies also funded by the agency.
For CIRM directors now to reject the
IOM findings and turn away would be to indicate that their earlier
admiration and respect for the IOM was something of a sham or, more
likely, now inconvenient.
IOM findings and turn away would be to indicate that their earlier
admiration and respect for the IOM was something of a sham or, more
likely, now inconvenient.
As for removing ambiguity about what
does or does not enhance the agency's mission, the 29-member board
could simply adopt a resolution declaring that all the IOM
recommendations would enhance the CIRM mission.
does or does not enhance the agency's mission, the 29-member board
could simply adopt a resolution declaring that all the IOM
recommendations would enhance the CIRM mission.
One of major obstacles to acting on the
earlier recommendations for changes was Robert Klein, the first
chairman of the agency board. Klein, an attorney and real estate investment
banker, also directed the writing of Proposition 71 and wrote
portions of it himself. He would often make numerical code citations
to the initiative during agency board meetings.
earlier recommendations for changes was Robert Klein, the first
chairman of the agency board. Klein, an attorney and real estate investment
banker, also directed the writing of Proposition 71 and wrote
portions of it himself. He would often make numerical code citations
to the initiative during agency board meetings.
Klein is now gone from the board,
leaving in 2011 at the end of his term. He was replaced by Jonathan
Thomas, a Los Angeles bond financier, who has ushered in a new and
different era at the stem cell agency. Some might say a more
reasonable era. He says he and governing board
take the IOM study seriously.
leaving in 2011 at the end of his term. He was replaced by Jonathan
Thomas, a Los Angeles bond financier, who has ushered in a new and
different era at the stem cell agency. Some might say a more
reasonable era. He says he and governing board
take the IOM study seriously.
The report is scheduled for discussion
Jan. 23 at a public workshop at the Claremont Hotel in Berkeley, Ca.,
the day before the regular board meeting. .
Jan. 23 at a public workshop at the Claremont Hotel in Berkeley, Ca.,
the day before the regular board meeting. .
The IOM's recommendations have won theeditorial endorsement of all the California newspapers that have so
far written about them. The newspapers believe that the proposals
would indeed enhance the agency's mission and are, in fact, necessary
if the agency is to survive beyond 2017, when the money for new
grants runs out.
far written about them. The newspapers believe that the proposals
would indeed enhance the agency's mission and are, in fact, necessary
if the agency is to survive beyond 2017, when the money for new
grants runs out.
Directors of the stem cell agency are
currently mulling the future of their efforts. If they are to be
successful in raising additional hundreds of millions of dollars –
be they private or public – the directors must confront the
findings of the IOM in a forthright manner. And they must move to
dispel the cloud that now hangs over the stem cell agency.
currently mulling the future of their efforts. If they are to be
successful in raising additional hundreds of millions of dollars –
be they private or public – the directors must confront the
findings of the IOM in a forthright manner. And they must move to
dispel the cloud that now hangs over the stem cell agency.
(Editor's note: The full text of the
2009 legal memo can be found below. Also below is another related
legal memo from Americans for Cures, a stem cell lobbying group
sponsored by Robert Klein at the same time he was chairman of the
stem cell agency. Despite the language on the Americans for Cures
memo, it is a public record. It became a public document when Klein
submitted it to the Little Hoover Commission.)
2009 legal memo can be found below. Also below is another related
legal memo from Americans for Cures, a stem cell lobbying group
sponsored by Robert Klein at the same time he was chairman of the
stem cell agency. Despite the language on the Americans for Cures
memo, it is a public record. It became a public document when Klein
submitted it to the Little Hoover Commission.)
- International Stem Cell Corporation Provides Strategic Update on its Skin Care Program [Last Updated On: April 9th, 2010] [Originally Added On: April 9th, 2010]
- International Stem Cell Corporation Provides Strategic Update on its Skin Care Program [Last Updated On: April 9th, 2010] [Originally Added On: April 9th, 2010]
- CSC news roundup 2010-04-11 [Last Updated On: April 12th, 2010] [Originally Added On: April 12th, 2010]
- CSC news roundup 2010-04-11 [Last Updated On: April 12th, 2010] [Originally Added On: April 12th, 2010]
- International Stem Cell Corporation Engages Leading Immunogeneticists to Advance its Industry-first, Immune-matched Stem Cells [Last Updated On: April 14th, 2010] [Originally Added On: April 14th, 2010]
- International Stem Cell Corporation Engages Leading Immunogeneticists to Advance its Industry-first, Immune-matched Stem Cells [Last Updated On: April 14th, 2010] [Originally Added On: April 14th, 2010]
- MicroRNA therapy could be a powerful tool to correct the CSC dysregulation? [Last Updated On: April 17th, 2010] [Originally Added On: April 17th, 2010]
- MicroRNA therapy could be a powerful tool to correct the CSC dysregulation? [Last Updated On: April 17th, 2010] [Originally Added On: April 17th, 2010]
- CSC news links 2010-04-18 [Last Updated On: April 19th, 2010] [Originally Added On: April 19th, 2010]
- CSC news links 2010-04-18 [Last Updated On: April 19th, 2010] [Originally Added On: April 19th, 2010]
- Sessions on CSC Therapeutics at AACR10 [Last Updated On: April 27th, 2010] [Originally Added On: April 27th, 2010]
- Sessions on CSC Therapeutics at AACR10 [Last Updated On: April 27th, 2010] [Originally Added On: April 27th, 2010]
- CSC news links 2010-05-01 [Last Updated On: May 2nd, 2010] [Originally Added On: May 2nd, 2010]
- More about presentations at AACR10 [Last Updated On: May 2nd, 2010] [Originally Added On: May 2nd, 2010]
- More about presentations at AACR10 [Last Updated On: May 2nd, 2010] [Originally Added On: May 2nd, 2010]
- CSC news links 2010-05-01 [Last Updated On: May 2nd, 2010] [Originally Added On: May 2nd, 2010]
- International Stem Cell Corporation Signs Financing Agreement [Last Updated On: May 6th, 2010] [Originally Added On: May 6th, 2010]
- International Stem Cell Corporation Signs Financing Agreement [Last Updated On: May 6th, 2010] [Originally Added On: May 6th, 2010]
- CSC news links 2010-05-08 [Last Updated On: May 9th, 2010] [Originally Added On: May 9th, 2010]
- CSC news links 2010-05-08 [Last Updated On: May 9th, 2010] [Originally Added On: May 9th, 2010]
- International Stem Cell and Absorption Systems Confirm Results Showing Stem Cell Derived Corneal Tissue as an Alternative to Animals for Drug Testing [Last Updated On: May 12th, 2010] [Originally Added On: May 12th, 2010]
- International Stem Cell and Absorption Systems Confirm Results Showing Stem Cell Derived Corneal Tissue as an Alternative to Animals for Drug Testing [Last Updated On: May 12th, 2010] [Originally Added On: May 12th, 2010]
- Generic drug a potential treatment for glioblastoma? [Last Updated On: May 14th, 2010] [Originally Added On: May 14th, 2010]
- Generic drug a potential treatment for glioblastoma? [Last Updated On: May 14th, 2010] [Originally Added On: May 14th, 2010]
- US Patent: Isolation and use of solid tumor stem cells [Last Updated On: May 18th, 2010] [Originally Added On: May 18th, 2010]
- US Patent: Isolation and use of solid tumor stem cells [Last Updated On: May 18th, 2010] [Originally Added On: May 18th, 2010]
- International Stem Cell Corporation and The Automation Partnership Enter into Strategic Alliance to Automate Cornea Tissue Production [Last Updated On: May 19th, 2010] [Originally Added On: May 19th, 2010]
- International Stem Cell Corporation and The Automation Partnership Enter into Strategic Alliance to Automate Cornea Tissue Production [Last Updated On: May 19th, 2010] [Originally Added On: May 19th, 2010]
- An evolving concept of CSC in tumor biology [Last Updated On: May 21st, 2010] [Originally Added On: May 21st, 2010]
- An evolving concept of CSC in tumor biology [Last Updated On: May 21st, 2010] [Originally Added On: May 21st, 2010]
- International Stem Cell Corporation Moves International Cornea Development Program Forward [Last Updated On: May 26th, 2010] [Originally Added On: May 26th, 2010]
- International Stem Cell Corporation Moves International Cornea Development Program Forward [Last Updated On: May 26th, 2010] [Originally Added On: May 26th, 2010]
- Phase I clinical trial of ICT-107 [Last Updated On: June 3rd, 2010] [Originally Added On: June 3rd, 2010]
- Phase I clinical trial of ICT-107 [Last Updated On: June 3rd, 2010] [Originally Added On: June 3rd, 2010]
- CSCs responsible for metastasis identified [Last Updated On: June 6th, 2010] [Originally Added On: June 6th, 2010]
- CSCs responsible for metastasis identified [Last Updated On: June 6th, 2010] [Originally Added On: June 6th, 2010]
- International Stem Cell Corporation's Parthenogenetic Stem Cell Patent is Approved by the United States Patent and Trademark Office [Last Updated On: June 9th, 2010] [Originally Added On: June 9th, 2010]
- International Stem Cell Corporation's Parthenogenetic Stem Cell Patent is Approved by the United States Patent and Trademark Office [Last Updated On: June 9th, 2010] [Originally Added On: June 9th, 2010]
- International Stem Cell Corporation Announces Company Update Conference Call. ISCO Chairman Kenneth Aldrich to Discuss 'Status of the Company' [Last Updated On: June 10th, 2010] [Originally Added On: June 10th, 2010]
- International Stem Cell Corporation Announces Company Update Conference Call. ISCO Chairman Kenneth Aldrich to Discuss 'Status of the Company' [Last Updated On: June 10th, 2010] [Originally Added On: June 10th, 2010]
- Decitabine may target ovarian CSCs? [Last Updated On: June 14th, 2010] [Originally Added On: June 14th, 2010]
- Decitabine may target ovarian CSCs? [Last Updated On: June 14th, 2010] [Originally Added On: June 14th, 2010]
- New Article from North County Times - BIOTECH: International Stem Cell Clears Debt, Gets Patent [Last Updated On: June 17th, 2010] [Originally Added On: June 17th, 2010]
- New Article from North County Times - BIOTECH: International Stem Cell Clears Debt, Gets Patent [Last Updated On: June 17th, 2010] [Originally Added On: June 17th, 2010]
- Patent application: Levels of Oct1 as a method of identifying CSCs [Last Updated On: June 18th, 2010] [Originally Added On: June 18th, 2010]
- Patent application: Levels of Oct1 as a method of identifying CSCs [Last Updated On: June 18th, 2010] [Originally Added On: June 18th, 2010]
- OncoMed Has 'Wnt' in its Sails [Last Updated On: June 21st, 2010] [Originally Added On: June 21st, 2010]
- OncoMed Has 'Wnt' in its Sails [Last Updated On: June 21st, 2010] [Originally Added On: June 21st, 2010]
- International Stem Cell Corporation Names Charles J. Casamento to Board of Directors [Last Updated On: June 23rd, 2010] [Originally Added On: June 23rd, 2010]
- International Stem Cell Corporation Names Charles J. Casamento to Board of Directors [Last Updated On: June 23rd, 2010] [Originally Added On: June 23rd, 2010]
- International Stem Cell Corporation (ISCO.OB) Announces New Patent Issuance Under License Agreement [Last Updated On: June 25th, 2010] [Originally Added On: June 25th, 2010]
- International Stem Cell Corporation (ISCO.OB) Announces New Patent Issuance Under License Agreement [Last Updated On: June 25th, 2010] [Originally Added On: June 25th, 2010]
- California Health Institute Interviews Jeffrey Janus - CEO of Lifeline Cell Technology [Last Updated On: June 29th, 2010] [Originally Added On: June 29th, 2010]
- California Health Institute Interviews Jeffrey Janus - CEO of Lifeline Cell Technology [Last Updated On: June 29th, 2010] [Originally Added On: June 29th, 2010]
- International Stem Cell Corporation - Excerpt from Agora Financial's Breakthrough Technology Alert by Patrick Cox [Last Updated On: July 1st, 2010] [Originally Added On: July 1st, 2010]
- International Stem Cell Corporation - Excerpt from Agora Financial's Breakthrough Technology Alert by Patrick Cox [Last Updated On: July 1st, 2010] [Originally Added On: July 1st, 2010]
- Melanoma-initiating cells identified [Last Updated On: July 2nd, 2010] [Originally Added On: July 2nd, 2010]
- Melanoma-initiating cells identified [Last Updated On: July 2nd, 2010] [Originally Added On: July 2nd, 2010]
- International Stem Cell Corporation and Sankara Nethralaya Launch Collaboration to Develop Stem Cell-Based Treatment for Corneal Vision Impairment [Last Updated On: July 8th, 2010] [Originally Added On: July 8th, 2010]
- International Stem Cell Corporation and Sankara Nethralaya Launch Collaboration to Develop Stem Cell-Based Treatment for Corneal Vision Impairment [Last Updated On: July 8th, 2010] [Originally Added On: July 8th, 2010]
- Two recent OA articles [Last Updated On: July 12th, 2010] [Originally Added On: July 12th, 2010]
- Two recent OA articles [Last Updated On: July 12th, 2010] [Originally Added On: July 12th, 2010]
- Innovative Researcher Vlog [Last Updated On: July 16th, 2010] [Originally Added On: July 16th, 2010]
- Innovative Researcher Vlog [Last Updated On: July 16th, 2010] [Originally Added On: July 16th, 2010]
- More about salinomycin [Last Updated On: July 19th, 2010] [Originally Added On: July 19th, 2010]
- More about salinomycin [Last Updated On: July 19th, 2010] [Originally Added On: July 19th, 2010]
- International Stem Cell Corporation Plans $10 Million Financing Through European Subsidiary [Last Updated On: July 23rd, 2010] [Originally Added On: July 23rd, 2010]
- International Stem Cell Corporation Plans $10 Million Financing Through European Subsidiary [Last Updated On: July 23rd, 2010] [Originally Added On: July 23rd, 2010]
- Irradiating brain's stem cell niche [Last Updated On: July 26th, 2010] [Originally Added On: July 26th, 2010]
- Irradiating brain's stem cell niche [Last Updated On: July 26th, 2010] [Originally Added On: July 26th, 2010]
- Prostate CSCs sensitive to gamma-tocotrienol? [Last Updated On: July 27th, 2010] [Originally Added On: July 27th, 2010]
- Prostate CSCs sensitive to gamma-tocotrienol? [Last Updated On: July 27th, 2010] [Originally Added On: July 27th, 2010]
- Researchers Study CSCs as Therapeutic Targets for Mesothelioma [Last Updated On: July 28th, 2010] [Originally Added On: July 28th, 2010]
- Researchers Study CSCs as Therapeutic Targets for Mesothelioma [Last Updated On: July 28th, 2010] [Originally Added On: July 28th, 2010]
- International Stem Cell Corporation and Sristi Biosciences Enter Distribution Agreement for Lifeline Cell Technology's Brand of Human Cell Culture... [Last Updated On: July 29th, 2010] [Originally Added On: July 29th, 2010]
- Disagreement about melanoma CSCs [Last Updated On: July 29th, 2010] [Originally Added On: July 29th, 2010]
- International Stem Cell Corporation and Sristi Biosciences Enter Distribution Agreement for Lifeline Cell Technology's Brand of Human Cell Culture... [Last Updated On: July 29th, 2010] [Originally Added On: July 29th, 2010]
- Disagreement about melanoma CSCs [Last Updated On: July 29th, 2010] [Originally Added On: July 29th, 2010]
- Cell of origin for human prostate cancer [Last Updated On: August 1st, 2010] [Originally Added On: August 1st, 2010]
- Cell of origin for human prostate cancer [Last Updated On: August 1st, 2010] [Originally Added On: August 1st, 2010]