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1.: DEFEND CALIFORNIA'S STEM CELL PROGRAM! Send one E-mail—or From: Stephen Meyer

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1.: DEFEND CALIFORNIA'S STEM CELL PROGRAM! Send one E-mail—or

Posted by: "Stephen Meyer" Stephen276@comcast.net stephen_meyer_stemcells

Fri Jun 13, 2008 12:17 pm (PDT)

DEFEND CALIFORNIA'S STEM CELL PROGRAM! Send one E-mail—or
Yourself?

Folks, your help is needed.

Tuesday, June 17, there will be a Sacramento hearing on a bill which
would (once again) attempt to hamstring the operations of the California
stem cell program.

Proposition 71 is under attack—again! Tuesday is a crucial hearing
to protect Prop 71, our wonderful stem cell program, and today is
Friday.

Can you come to Sacramento that day? If so, drop me an email here.

Before then, there is work to be done. Today, in about half an hour, I
will be on the road to Sacramento to visit the offices of the members of
the Health Assembly Committee.

They don't know I'm coming, and it will be like, "Oh, you
don't have an appointment? No? Oh, well, the person you should
really talk to Susan______, but she is in a meeting, could you come back
in 2 hours and 37 minutes?" Which I will say of course, write the
time down, say thank you very much, and go on to the next of the 26
offices…

No matter what state you live in, the California stem cell research
program is for you.

But the hearing is the crucial thing. If our side is not represented, we
will lose. So far the patient advocate side basically has not been
heard. I have been there babbling at all four hearings, but nobody else,
and the bill has not received a single no vote.

You personally can help. Doing nothing, hoping someone else will show
up, is the way to lose. If you are in driving distance of Sacramento,
please consider joining me at the hearing. I do not have the hour or the
room number, but will know them soon.

If you cannot come yourself, could you send an email?

Consider sending an email (the same one) to each member of the
committee.

One sentence is all that is really needed, and you do not have to live
in their district.

It could be short: "As a supporter of stem cell research, I urge
your NO vote on Senate Bill 1565. "

Or long as you want.

Here is the letter I sent:

NAME, ADDRESS AND PHONE NUMBER

As the father of a paralyzed young man, and the sponsor of a successful
California law supporting spinal cord injury research*, I strongly
oppose SB 1565 (Kuehl/Runner), a bill with many hidden threats.

Three reasons leap to mind:

1. SB 1565 would require the Little Hoover Commission to investigate the
California Institute for Regenerative Medicine (CIRM)—for a fourth
time. The California stem cell program has already been investigated
(and found squeaky clean) three times. Further dissection is not only a
waste of taxpayer dollars, but also a distraction from duty on an
already short-handed CIRM staff.

2. By mandating a one-size-fits-all approach to affordable access for
uninsured Californians, (a goal we all share) SB 1565 would deny
bargaining ability to the CIRM. This could defeat the CIRM's ability
to negotiate with corporations. For instance, diseases like Spinal
Muscle Atrophy (SMA) devastate lives of infants and their families, but
the number of patients is not a large enough market to attract corporate
investment. If CIRM retains its bargaining ability, (which SB 1565
threatens) it could offer flexibility in pricing on one area, in
exchange for industry involvement in an "orphan disease" like
SMA, thus potentially saving lives and advancing science for the good of
all.

3. Co-author Senator George Runner, who has been described as
"virulently anti-embryonic" in terms of stem cell research,
reportedly seeks a new change in SB 1565. Senator Runner wishes to
increase funding for the more conservatively-favored "adult"
stem cell research, the type approved (and preferentially funded) by the
Bush Administration. To backpedal now would be to deny the will of the
California voters.

While doubtless begun with the best intentions, SB 1565 would be a
frustrating obstacle to the California stem cell program, and all who
support research for cure.

On behalf of millions who suffer chronic disease and disability, and who
look to embryonic stem cell research for hope, I urge your strong
opposition to SB 1565.

Sincerely,

Don C. Reed

* California's Roman Reed Spinal Cord Injury Research Act of
1999, named after my paralyzed son, provided funding for a paralysis
treatment developed by Geron, which is currently under discussion by the
FDA, and we hope it will soon go to human trials.

Okay, that was my letter. Yours does not have to be so elaborate. A
sentence or two is fine.

Below are the email addresses. The bill itself is the very bottom of
the page,

Thanks, and I hope to see you at the hearing, June 17th!

Best,

Don

Assembly Health Committee

Mervyn M. Dymally - Chair

Dem-52

(916) 319-2052

Assemblymember.dymally@assembly.ca.gov
<mailto:Assemblymember.dymally@assembly.ca.gov>

Alan Nakanishi - Vice Chair

Rep-10

(916) 319-2010

Assemblymember.nakanishi@assembly.ca.gov
<mailto:Assemblymember.nakanishi@assembly.ca.gov>

Patty Berg

Dem-1

(916) 319-2001

Assemblymember.berg@assembly.ca.gov
<mailto:Assemblymember.berg@assembly.ca.gov>

Wilmer Amina Carter

Dem-62

(916) 319-2062

Assemblymember.Carter@assembly.ca.gov
<mailto:Assemblymember.Carter@assembly.ca.gov>

Hector De La Torre

Dem-50

(916) 319-2050

Assemblymember.DeLaTorre@assembly.ca.gov
<mailto:Assemblymember.DeLaTorre@assembly.ca.gov>

Kevin de Leon

Dem-45

(916) 319-2045

Assemblymember.deLeon@assembly.ca.gov
<mailto:Assemblymember.deLeon@assembly.ca.gov>

Bill Emmerson

Rep-63

(916) 319-2063

Assemblymember.emmerson@assembly.ca.gov
<mailto:Assemblymember.emmerson@assembly.ca.gov>

Ted Gaines

Rep-4

(916) 319-2004

Assemblymember.Gaines@assembly.ca.gov
<mailto:Assemblymember.Gaines@assembly.ca.gov>

Loni Hancock

Dem-14

(916) 319-2014

Assemblymember.hancock@assembly.ca.gov
<mailto:Assemblymember.hancock@assembly.ca.gov>

Mary Hayashi

Dem-18

(916) 319-2018

Assemblymember.Hayashi@assembly.ca.gov
<mailto:Assemblymember.Hayashi@assembly.ca.gov>

Edward P. Hernandez

Dem-57

(916) 319-2057

Assemblymember.Hernandez@assembly.ca.gov
<mailto:Assemblymember.Hernandez@assembly.ca.gov>

Bob Huff

Rep-60

(916) 319-2060

Assemblymember.huff@assembly.ca.gov
<mailto:Assemblymember.huff@assembly.ca.gov>

Dave Jones

Dem-9

(916) 319-2009

Assemblymember.jones@assembly.ca.gov
<mailto:Assemblymember.jones@assembly.ca.gov>

Sally J. Lieber

Dem-22

(916) 319-2022

Assemblywoman.lieber@assembly.ca.gov
<mailto:Assemblywoman.lieber@assembly.ca.gov>

Fiona Ma

Dem-12

(916) 319-2012

Assemblymember.Ma@assembly.ca.gov
<mailto:Assemblymember.Ma@assembly.ca.gov>

Mary Salas

Dem-79

(916) 319-2079

Assemblymember.Salas@assembly.ca.gov
<mailto:Assemblymember.Salas@assembly.ca.gov>

Audra Strickland

Rep-37

(916) 319-2037

Assemblymember.strickland@assembly.ca.gov
<mailto:Assemblymember.strickland@assembly.ca.gov>

Dave Jones - Chair

Dem-9

(916) 319-2009

Assemblymember.jones@assembly.ca.gov
<mailto:Assemblymember.jones@assembly.ca.gov>

Van Tran - Vice Chair

Rep-68

(916) 319-2068

Assemblymember.tran@assembly.ca.gov
<mailto:Assemblymember.tran@assembly.ca.gov>

Anthony Adams

Rep-59

(916) 319-2059

Assemblymember.Adams@assembly.ca.gov
<mailto:Assemblymember.Adams@assembly.ca.gov>

Noreen Evans

Dem-7

(916) 319-2007

Assemblymember.Evans@assembly.ca.gov
<mailto:Assemblymember.Evans@assembly.ca.gov>

Mike Feuer

Dem-42

(916) 319-2042

Assemblymember.Feuer@assembly.ca.gov
<mailto:Assemblymember.Feuer@assembly.ca.gov>

Rick Keene

Rep-3

(916) 319-2003

Assemblymember.keene@assembly.ca.gov
<mailto:Assemblymember.keene@assembly.ca.gov>

Paul Krekorian

Dem-43

(916) 319-2043

Assemblymember.Krekorian@assembly.ca.gov
<mailto:Assemblymember.Krekorian@assembly.ca.gov>

John Laird

Dem-27

(916) 319-2027

Assemblymember.laird@assembly.ca.gov
<mailto:Assemblymember.laird@assembly.ca.gov>

Lloyd E. Levine

Dem-40

(916) 319-2040

Assemblymember.levine@assembly.ca.gov
<mailto:Assemblymember.levine@assembly.ca.gov>

Sally J. Lieber

Dem-22

(916) 319-2022

Assemblywoman.lieber@assembly.ca.gov
<mailto:Assemblywoman.lieber@assembly.ca.gov>

Here is the full text of the bill.

BILL NUMBER: SB 1565 AMENDED

BILL TEXT

AMENDED IN ASSEMBLY JUNE 9, 2008

AMENDED IN SENATE APRIL 16, 2008

INTRODUCED BY Senators Kuehl and Runner

( Coauthor: Senator Wiggins

)

(Coauthor: Assembly Member Jones)

FEBRUARY 22, 2008

An act to amend Section 125290.60 of, and to add

Section 125293 to , the Health and Safety Code, relating to

reproductive health.

LEGISLATIVE COUNSEL'S DIGEST

SB 1565, as amended, Kuehl. California Stem Cell Research and

Cures Act.

The California Stem Cell Research and Cures Act (the act), an

initiative measure approved by the voters at the November 2, 2004,

statewide general election as Proposition 71, establishes the

California Institute for Regenerative Medicine (CIRM), the purpose of

which is, among other things, to make grants and loans for stem cell

research, for research facilities, and for other vital research

opportunities to realize therapies, protocols, and medical procedures

that will result in the cure for, or substantial mitigation of,

diseases and injuries. Existing law establishes the Independent

Citizen's Oversight Committee (ICOC) composed of appointed members,

that is required to perform various functions and duties with regard

to the operation of the institute, including, but not limited to,

establishing standards applicable to research funded by the

institute. Existing law prohibits amendment of Proposition 71 by the

Legislature unless the amendment is approved by the voters, or the

amendment is accomplished by a bill introduced after the first 2 full

calendar years and approved by a vote of 70% of both houses, and

only if the amendment enhances the ability of the institute to

further the purposes of the grant and loan programs.

Existing provisions of Proposition 71 provide

The act provides that the ICOC shall establish standards

that require that all grants and loan awards under the act shall be

subject to intellectual property agreements that balance the

opportunity of the state to benefit from the patents, royalties, and

licenses that result from basic research, therapy development, and

clinical trials with the need to assure that essential medical

research is not unreasonably hindered by the intellectual property

agreements.

This bill would require that intellectual property standards that

the ICOC develops shall include a requirement that each grantee and

the licensees of the grantee submit to the CIRM for approval a plan

that will afford uninsured Californians access to any drug that is,

in whole or in part, the result of research funded by the CIRM, and

would require that any plan subject to that approval shall require

that the grantees and licensees thereof sell drugs at a price that

does not exceed any benchmark price in the California Discount

Prescription Drug Program.

The act provides that the CIRM shall have 3 separate scientific

and medical working groups, including the Scientific and Medical

Research Funding Working Group, which, among other things, shall make

grant and loan award recommendations to the ICOC. Existing law

provides that, in order to ensure CIRM funding does not duplicate or

supplant existing funding, certain research categories shall not be

funded by the CIRM, except when at least 2/3 of a quorum of the

members of the Scientific and Medical Research Funding Working Group

recommend to the ICOC that such a research proposal is a vital

research opportunity.

This bill would, instead, only require a simple majority of a

quorum of the members of the Scientific and Medical Research Funding

Working Group to recommend to the ICOC that a particular research

proposal is a vital research opportunity.

Existing law establishes the Milton Marks "Little Hoover"

Commission on California State Government Organization and Economy, a

multimember body appointed by the Governor and the Legislature with

various duties that include making recommendations to the Governor

and the Legislature to promote efficiency in government operations.

This bill would require request the

commission to conduct a study of the governance structure of the

California Stem Cell Research and Cures Act. This bill would

, by July 1, 2009, require the commission to provide

that if the commission conducts the study, it shall, by July 1, 2009,

submit, to the appropriate committees of each house of the

Legislature, a report on the results of the study and recommendations

of ways the governance structure of the ICOC could better ensure

public accountability and reduce conflicts of interest, consistent

with the purposes of Proposition 71, and would require the commission

to make the report available to the public.

Vote: 70%. Appropriation: no. Fiscal committee: yes.

State-mandated local program: no.

THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

SECTION 1. Section 125290.60 of the

Health and Safety Code is amended to read:

125290.60. Scientific and Medical Research Funding Working Group

(a) Membership

The Scientific and Medical Research Funding Working Group shall

have 23 members as follows:

(1) Seven ICOC members from the 10 disease advocacy group members

described in paragraphs (3), (4), and (5) of subdivision (a) of

Section 125290.20.

(2) Fifteen scientists nationally recognized in the field of stem

cell research.

(3) The Chairperson of the ICOC.

(b) Functions

The Scientific and Medical Research Funding Working Group shall

perform the following functions:

(1) Recommend to the ICOC interim and final criteria, standards,

and requirements for considering funding applications and for

awarding research grants and loans.

(2) Recommend to the ICOC standards for the scientific and medical

oversight of awards.

(3) Recommend to the ICOC any modifications of the criteria,

standards, and requirements described in paragraphs (1) and (2) above

as needed.

(4) Review grant and loan applications based on the criteria,

requirements, and standards adopted by the ICOC and make

recommendations to the ICOC for the award of research, therapy

development, and clinical trial grants and loans.

(5) Conduct peer group progress oversight reviews of grantees to

ensure compliance with the terms of the award, and report to the ICOC

any recommendations for subsequent action.

(6) Recommend to the ICOC standards for the evaluation of grantees

to ensure that they comply with all applicable requirements. Such

standards shall mandate periodic reporting by grantees and shall

authorize the Scientific and Medical Research Funding Working Group

to audit a grantee and forward any recommendations for action to the

ICOC.

(7) Recommend its first grant awards within 60 days of the

issuance of the interim standards.

(c) Recommendations for Awards

Award recommendations shall be based upon a competitive evaluation

as follows:

(1) Only the 15 scientist members of the Scientific and Medical

Research Funding Working Group shall score grant and loan award

applications for scientific merit. Such This

scoring shall be based on scientific merit in three separate

classifications--research, therapy development, and clinical trials,

on criteria including the following:

(A) A demonstrated record of achievement in the areas of

pluripotent stem cell and progenitor cell biology and medicine,

unless the research is determined to be a vital research opportunity.

(B) The quality of the research proposal, the potential for

achieving significant research, or clinical results, the timetable

for realizing such significant results, the importance of the

research objectives, and the innovativeness of the proposed research.

(C) In order to ensure that institute funding does not duplicate

or supplant existing funding, a high priority shall be placed on

funding pluripotent stem cell and progenitor cell research that

cannot, or is unlikely to, receive timely or sufficient federal

funding, unencumbered by limitations that would impede the research.

In this regard, other research categories funded by the National

Institutes of Health shall not be funded by the institute.

(D) Notwithstanding subparagraph (C), other scientific and medical

research and technologies and/or any stem cell research proposal not

actually funded by the institute under subparagraph (C) may be

funded by the institute if at least two-thirds

a simple majority of a quorum of the members of the

Scientific and Medical Research Funding Working Group recommend to

the ICOC that such a research proposal is a vital

research opportunity.

SECTION 1. SEC. 2. Section 125293 is

added to the Health and Safety Code, to read:

125293. (a) The intellectual property standards that the ICOC

develops shall include a requirement that each grantee and the

licensee of the grantee submit a plan to the California Institute for

Regenerative Medicine (CIRM) that will afford uninsured Californians

access to any drug that is, in whole or in part, the result of

research funded by the CIRM.

(b) The ICOC shall require submission of the plan required by

subdivision (a) before a drug is placed into commerce. The plan shall

be subject to the approval of the CIRM, after a public hearing and

opportunity for public comment.

(c) (1) Any plan subject to subdivision (a) shall include a

requirement that each grantee and any licensee of the grantee that

sells drugs that are, in whole or in part, the result of research

funded by CIRM and that are purchased in California with public funds

shall sell those drugs at a price that does not exceed any benchmark

price in the California Discount Prescription Drug Program (Division

112 (commencing with Section 130500)), as it exists on January 1,

2008.

(2) Paragraph (1) shall not preclude any public agency from

obtaining prices that are lower than the price determined as

described in paragraph (1) through negotiation, bulk purchasing, or

any other purchasing arrangement and shall not be construed to

conflict with, or preempt, any other provision of state or federal

law or regulation that would result in lower drug prices.

(d) For purposes of this section, "drug" includes any article

recognized in the United States Pharmacopeia or supplement thereof,

the National Formulary, or any supplement thereof, and any article

intended for the diagnosis, cure, mitigation, or prevention of

disease in humans or animals, or any article intended for use as a

component thereof, and shall include therapeutic products, including,

but not limited to, blood, blood products, cells, and cell

therapies.

SEC. 2. SEC. 3. (a) The

Legislature hereby requests the Milton Marks "Little Hoover"

Commission on California State Government Organization and Economy

shall to conduct a study of the

governance structure of the California Stem Cell Research and Cures

Act, an initiative measure approved by the voters at the November 2,

2004, statewide general election (Proposition 71), including the

membership of the Independent Citizens

Citizen's Oversight Committee and the relative roles of the

committee and the California Institute for Regenerative Medicine.

(b) By If the commission conducts the

study described in subdivision (a), the commission shall, by

July 1, 2009, the commission shall submit,

submit to the appropriate committees of each house of the

Legislature, a report on the results of the study required

requested by subdivision (a) and recommendations

of ways the governance structure of the Independent Citizen's

Oversight Committee could better ensure public accountability and

reduce conflicts of interest, consistent with the purposes of

Proposition 71. The commission shall make the report available to the

public.

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