the california stem cell program at one year...proposition 71, a land-mark initiative author-izing...

The California Stem CellProgram at One Year

A Progress Report

CENTER FOR

GENETICS ANDSOCIETY


A Progress ReportJanuary 2006

About the Center for Genetics and Society

The Center for Genetics and Society is a nonprofit public affairs organization working toencourage responsible uses and effective societal governance of the new human genetic andreproductive technologies

CGS works in a context of support for the equitable provision of health technologies domes-tically and internationally for womenrsquos health and reproductive rights for the protection ofour children for the rights of the disabled and for precaution in the use of technologies thatcould alter the fundamental processes of the natural world

CGS supports benign and beneficent medical applications of the new human genetic andreproductive technologies and opposes those applications that objectify and commodifyhuman life and threaten to divide human society

CGS supports embryonic stem cell research and public funding for it We believe that thisresearch should and can be conducted in a responsible manner with effective oversight andin the public interest

CGS is a project of the Tides Center

The Center for Genetics and Society

436 14th Street Suite 700

Oakland CA 94612

1-510-625-0819 tel

1-510-625-0874 fax

wwwgenetics-and-societyorg

infogenetics-and-societyorg

For more information or additional copies of this report

2

The California Stem Cell Program at One Year

Table of ContentsPrologue 3

Box CIRM Year One Progress Report 3

Introduction 5

Report format 6

Box The California Institute for Regenerative Medicine7

Keeping Campaign Promises 8

Ensuring returns on public investments 8

Box Did CIRM leadership mislead voters about the prospect for financial returns 9

Maximizing health equity 10

Recommendations11

Establishing Accountable and Responsible Governance 12

Building organizational infrastructure 12

Minimizing conflicts of interest 12

Cooperating with the state legislature 13

Fostering transparency with open meetings14

Providing responsible leadership 15

Box Stem cell politics in the states and in Congress 15

Recommendations16

Establishing Ethical Safeguards and Research Standards 17

Protecting women who provide eggs for research and other research subjects 17

Preventing reproductive cloning and other unacceptable applications of stem cell technologies 18

Recommendations19

Conclusion Key Issues in the Coming Year20

Appendix 1 Timeline 22

Appendix 2 The Independent Citizens Oversight Committee 24

Appendix 3 Personal Conflicts of Interest on the ICOC26

Endnotes 28

Acknowledgments 32

3

Center for Genetics and Society

The debate over embryonic stem cells and cloning is aheated and contentious one Until recently it has beenshaped largely by its proximity to the debate over themoral status of human embryos with liberal and con-servative forces quickly aligning in predictable ways Asa consequence other social political and ethical con-cerns raised by stem cell and cloning research includ-ing many grounded in core liberal and progressive val-ues have not received the attention they urgently need

This situation is now beginning to change The cloningscandals centered in South Korea have cast a spotlight ona host of issues that have previously received only pass-ing attention These include the well-being of womenwho provide eggs for cloning research the prospect of amarket in eggs that could exploit economically vulnera-

ble women the lack of effective oversight and regulationof stem cell and cloning research the dangers that desiresfor commercial gain and personal renown pose to theintegrity of science and the risks posed by exaggeratedpromises of biomedical breakthroughs

In California these and related questions have begun tofigure in the public debate In November 2004 voterspassed a ballot initiative authorizing $3 billion in pub-lic funds for a new stem cell research program and anew state agency to administer it The California pro-gram is the largest and politically most significant ofseveral state-level stem cell efforts that have beenundertaken to circumvent the Bush administrationrsquosrestrictive policies on federal funding of embryonicstem cell research

Prologue

Keeping Campaign Promises CndashEnsuring returns on public investments C

Maximizing health equity D

Establishing Accountable and Responsible Governance CndashBuilding organizational infrastructure C

Minimizing conflicts of interest D

Cooperating with the state legislature D

Fostering transparency with open meetings B

Providing responsible leadership D

Establishing Ethical Safeguards and Research Standards C+Protecting women who provide eggs for research and other research subjects C+

Preventing reproductive cloning and other unacceptable applications of stem cell technologies C

CIRM Progress Report Overall grade for the first year Cndash

4


The California stem cell initiative has pushed the debateabout stem cell and cloning research into new and unex-plored terrain In the year since the passage of the stemcell initiative elected officials journalists public interestgroups and the public at large have been forced to grap-ple with questions they have never before had to address

What types of stem cell research should receive priorityfunding How can the health of women who provideeggs for cloning research be protected How shouldintellectual property rights be distributed amongresearchers corporations universities and the stateWhat sort of public hearings and review are necessarybefore state funds are appropriated for controversialresearch How do we ensure that any medical treat-ments resulting from state-sponsored stem cell researchare affordable by the majority of California residentsHow do we prevent stem cell and cloning technologiesfrom being used for socially unacceptable purposes

Stem cell technologies may someday point the waytoward new and powerful approaches to treating diseaseBut if misused these same technologies could also harmindividuals exacerbate health inequities and open thedoor to unacceptable applications such as inheritablehuman genetic modification and reproductive cloning Ifwe are to realize the benefits of stem cell research andavoid the risks it poses effective structures of regulatoryoversight and control must be top priorities

This report on the first year of Californiarsquos experience inestablishing and governing a major state-funded stemcell research program is meant to inform the continueddebate in California in other states at the national leveland internationally We believe that the lessons learnedfrom this experience need to be taken to heart if researchon stem cells and other emerging biotechnologies is to bepursued in a responsible and effective manner

5


In November 2004California voters passedProposition 71 a land-mark initiative author-izing $3 billion in tax-payer-supported bondsto support stem cellresearch in CaliforniaThe proposition estab-

lished the California Institute for RegenerativeMedicine (CIRM) to distribute the funds and overseethe program

Proposition 71 launched two experiments The first isan experiment in a new field of biomedical investiga-tion the second an experiment in politics and policyNever before has a state so generously funded anemerging scientific field And never before has a statebeen faced with the task of establishing a system of reg-ulation and oversight for a field of biomedical researchthat combines the promise of medical advance withsuch significant social risks

CIRM-funded research is yet to begin and the field ofstem cell research is itself still in its very early stagesBut the CIRM has been in operation for a year andmany critical decisions affecting the future of the pro-gram have been made during this period

The Center for Genetics and Society along with otherpublic interest groups and experts in health lawwomenrsquos health public policy and open governmenthas closely followed Proposition 71rsquos implementationWe believe that this is an appropriate time to offer aninitial evaluation of its performance on matters of gov-ernance politics and policy

On these measures the CIRMrsquos first year has been agreat disappointment In terms of governance theCIRM has often failed to operate as an accountableresponsible and transparent state agency In the area ofpolitics it has failed to establish a cooperative relation-ship with state legislators And in the policy arena theCIRM has fallen far short of the expectations raisedduring the initiative campaign that led to its creation It

has so far failed to adopt policies to ensure that any suc-cessful stem cell therapies will be affordable to mostCalifornians or to reassure Californians that they willsee any share of financial returns that the research theyare funding may generate

As explained below this report evaluates the perform-ance of the California stem cell research program inseveral critical areas and assigns a letter grade to eachFor its overall performance during its first year webelieve that the CIRM merits a grade of Cndash

Some defenders of the CIRM blame its shortcomings onthe lawsuits that challenge Proposition 71s constitu-tionality Until these suits are resolved by the courtsthe state cannot sell the CIRM bonds that are author-ized by the initiative Although the suits have interferedwith the CIRMs ability to provide funds for researchawards they have no bearing on the issues on whichthis evaluation is based CIRM leadership could haveused the delay imposed by the lawsuits to establishaccountable and responsible governance structuresUnfortunately this has not happened1

Public oversight and responsible governance of state-funded activities are cornerstones of democratic societyThey will not hinder stem cell science on the contrarythey are essential if success is to be realized As KathayFeng of Common Cause of California and StevenBlackledge of California Public Interest Research Groupwrote in June 2005 ldquoAll it would take is one major scan-

Introduction

The CIRMrsquos first year has been a great

disappointment It has often failed to

operate as an accountable responsi-

ble and transparent state agency It

has failed to establish a cooperative

relationship with state legislators

Overall grade forthe CIRMrsquos firstyear

C-

6


dal some sign of mismanagement or ethical lapse andCaliforniansrsquo trustmdashand $6 billion investmentmdashin stem-cell research could be permanently damaged That is whyit is critical we ensure that safeguards are in placerdquo2

We recognize that many critical decisions about whowill benefit and how the stem cell research program willproceed are still to be made We know too that somemembers of the CIRMrsquos governing board and staff arecommitted to improving the agencyrsquos performance The

CIRM still has the opportunity to develop and imple-ment responsible policies We hope that it will do so

Report format

This Progress Report evaluates the performance of theCIRM and its governing board the Independent CitizensOversight Committee (ICOC) in three major areas

1 Its record in honoring the promises made toCalifornia voters during the Proposition 71 campaign

2 Its record in establishing itself as an accountableand responsible governing body

3 Its record in establishing ethical safeguards andresearch standards

In each of these areas we have assigned a grade thatreflects our considered assessment of the conduct andaccomplishments of the California stem cell researchprogram over the past year We provide a narrative eval-uation that explains each grade and a set of recommen-dations for improvement

The concluding section of this report identifies keychallenges that the program faces in the coming yearand beyond

ldquoAll it would take is one major scandal

some sign of mismanagement or ethical

lapse and Californiansrsquo trustmdashand $6

billion investmentmdashin stem-cell research

could be permanently damaged That is

why it is critical we ensure that safe-

guards are in placerdquo

Kathay Feng Common Cause ofCalifornia and Steven Blackledge

California Public Interest Research Group


7

The California Institute for Regenerative Medicine

The California Institute for RegenerativeMedicine (CIRM) is a new state agency that wascreated by the passage of Proposition 71 inNovember 20041 The CIRM will distribute $3 bil-lion of public money to fund stem cell researchand build research facilities over the next tenyears The CIRM is mandated to prioritize fund-ing for embryonic stem cell research andresearch cloning The funds it allocates will begenerated by the sale of state bonds at a totalcost including interest of $6 billion to $7 billion

The CIRM is governed by a twenty-nine mem-ber governing board the Independent CitizensOversight Committee (ICOC) It is composed ofofficers from public and private universities andnonprofit research centers representatives ofbiotechnology corporations and disease-spe-cific patient advocates Twenty-seven membersare appointed by California elected officialsand chancellors of the University of Californiasystem who select them on the basis of theinstitutional or patient advocacy affiliationsspecified by Proposition 71 The chair and vice-chair are then elected by these members fromcandidates nominated by the elected officials

Proposition 71 establishes three ICOC advisorycommittees called Working Groups one eachfor research grants facilities grants andresearch standards The members of theWorking Groups include the ICOC chair andsome of the representatives of disease-specificadvocacy organizations on the ICOC as well asoutside experts

Proposition 71 amends the state constitution toestablish a constitutional right to conduct stem

cell research It prohibits legislative modifica-tion for the first three years and afterwardsrequires a 70 super-majority in both housesmdasha nearly impossible thresholdmdashand the gover-norrsquos signature

The impetus for Proposition 71 was the restrictivepolicy on federal funding of embryonic stem cellresearch imposed by President Bush in August2001 It was initiated by wealthy California fami-lies with children affected by conditions that maysomeday be treated with cell-based therapiesand supported by many researchers and disease-specific patient advocacy groups

The campaign for Proposition 71 was based onclaims of near-term cures and promised eco-nomic benefits to the state It drew supportfrom many who opposed the Bush restrictionson stem cell funding or who saw it as anopportunity to express their general oppositionto the Bush administration The ldquoYes on 71rdquocampaign spent $35 million almost half fromventure capitalists and the proposition passedby 59 to 41 percent2

Notes

1 The text of Proposition 71 is athttpwwwyeson71cominitiativephp

2 Campaign expenses and returns are both pub-lished by the California Secretary of State onlineat httpcal-accesssscagovCampaignCommitteesDetailaspxid=1260661ampsession=2003 and httpwwwsscagovelectionssov2004_generalcontentshtm respectively

8


In evaluating the pastyearrsquos performance wehave taken into accountthe text of Proposition71 and statements madeby the current CIRMleadership during theinitiative campaign

Robert Klein was Proposition 71rsquos chief author cam-paign chair and largest donor he now chairs theIndependent Citizens Oversight Committee (ICOC)the appointive body established by Proposition 71 tooversee the CIRM Other prominent Proposition 71supporters and campaign staff are now among theboard and staff of the CIRM3 Thus it is appropriate tohold the current CIRM leadership accountable to thelanguage used in the campaign as well as in the initia-tive itself

The Proposition 71 campaign repeatedly pledged thatstem cell research would result in ldquocures forCaliforniansrdquo and that the $3 billion public cost of thestem cell research program along with an estimatedadditional $3 billion in interest payments would berecouped4 Television ads featured scientists in whitecoats describing stem cellndashbased cures as if they werecertain and imminent5 Initiative promoters insistedthat the program would at least pay for itself6

These inflated promises helped persuade Californiansto approve an unprecedented spending authorizationon a fledgling field of research at a time when our statewas deeply in debt and cutting public services

The low grades assigned here are in part motivated bytwo developments of great concern first recent disclo-sures that the leaders of the Proposition 71 campaignknowingly misled voters about the prospect of financialreturns and second growing indications that the CIRMmay be turning its back both on explicit pledges offinancial returns to California and on implicit promisesthat any successfully developed stem cell treatmentswould be available to all Californians

Ensuring returns on public investments

Both the affordability and accessibility ofany successfully developed treatments andthe prospect of the state receiving a share ofany profits depend on the intellectual

property (IP) agreements that the CIRM makes with theresearchers and institutions that will receive its grantsThe language of Proposition 71 requires that the CIRMpursue financial returns to the state Though the propo-sition is unspecific about how and to what extent thisshould be done supporters and CIRM leaders made itvery clear during the campaign that the voters couldexpect such returns7

However some ICOC members have argued against poli-cies that would provide a share of revenues to the stateTheir statements have raised serious concerns aboutwhether the CIRM will honor the promises made toCalifornia voters and the requirements of Proposition 71

The editorial board of the San Francisco Chroniclewhich strongly supported Proposition 71 voiced similarconcerns soon after the election On December 9 2004it wrote ldquoWe recognize that with the stem-cell initiativestill sitting on the landing pad that talk of huge profits10 to 20 years down the road may seem premature Butthis is precisely the time to make sure the taxpayersrsquointerests are safeguarded It will be far more difficult todo so when and if profits start to materializerdquo8

In its deliberations to date on the kind of IP agreementsit will adopt the leadership of the CIRM has consultedwith only a narrow range of stakeholders Almost with-out exception they have been industry and academicfigures whose policy recommendations would perpetu-ate a system in which revenues are not shared with thestate and which provides no assurances of accessiblepricing Experts in public health consumer and publicinterest groups and critics of current policies have notbeen invited into the discussion in any meaningful way9

ICOC deliberations about intellectual property havedrawn heavily on a report prepared by a committeeestablished by the California Council on Science and

Keeping promises

C-

Keeping Campaign Promises

C

9


According to a front-page article in theOctober 25 2005 San Francisco Chronicle ICOCChair Robert Klein knew during the 2004 cam-paign that the public cost of the stem cellresearch program was likely to entail hundredsof millions of dollars more in interest paymentsthan the estimates he and others were citing tovoters The article asserts that Klein howeverchose to conceal this information If true thisconstitutes a ldquobait and switchrdquo approach thatis a clear betrayal of the publicrsquos trust1

The Chronicle reported that state legal expertstold Robert Klein during the campaign thattax-exempt bonds probably could not be usedto finance the stem cell institute if the statewere to receive a share of revenue from suc-cessful inventions as promised If the CIRMrelies on taxable bonds the public cost of theprogram will wind up being between $423 mil-lion and almost $1 billion more than estimatedin the campaignrsquos economic analysis If on theother hand tax-exempt bonds are sold CIRMmay be prohibited by law from sharing rev-enues with the state which the campaignrsquoseconomic analysis valued at up to $11 billion2

Despite apparently knowing this to be thecase Robert Klein allowed the campaign tocontinue claiming repeatedly that the initiativewould pay for itself or even generate a surplusfor the state A week before the election Kleinhimself asserted on national television thatldquothe state of California will gain jobs new taxrevenues and intellectual property revenues topay back the taxpayersrdquo3

When asked why he did not inform the authorsof the economic study funded by the ldquoYes on

71rdquo campaign which he chaired Klein saidldquoIrsquod want to go back and review this areardquo4 Hehas not publicly responded to this since

A question that must now be asked is whetherRobert Klein and possibly other campaignsupporters who were aware of the situationwere ever committed to having the statereceive royalties

Notes

1 Bernadette Tansey ldquoTax law casts doubt on stem cellroyalties State may not reap billions promised tovoters last fallrdquo San Francisco Chronicle (October 252005) at httpwwwsfgatecomcgi-binarticlecgifile=ca20051025MNGTFFDK8J1DTL

2 See Tansey supra note 1 and Laurence Baker andBruce Deal ldquoEconomic Impact AnalysisProposition 71 California Stem Cell Research andCures Initiativerdquo (September 14 2004) athttpwwwyeson71comdocumentsProp71_Economic_Reportpdf The low end of the additionalcost imposed by taxable bonds is from a letter byCalifornia Treasurer Phil Angelides to CIRMPresident Zach Hall (October 26 2005) online athttpwwwetopiamedianetempnnpdfsangelides-hall1pdf The high end is offered bySen Ortiz in Tansey supra note 1

3 Newshour with Jim Lehrer (October 27 2004)transcript at httpwwwpbsorgnewshourbbpoliticsjuly-dec04stemcell_10-27html

4 Stuart Leavenworth ldquoStem cell royalty promisejust election ruserdquo Sacramento Bee (November7 2005) at httpwwwsacbeecomcontentopinionstory13826776p-14667506chtml

Did CIRM leadership mislead voters about the prospect for financial returns

10


Technology The committee is dominated by privateindustry and university technology transfer officeswhich would see their own shares of profits diminish ifthe state were to receive a portion The report was fund-ed by the California Healthcare Institute an industryadvocacy organization10 In August 2005 the commit-tee recommended that the CIRM dispense with anyintention of providing a share of profits to California

There are alternatives Some analysts including MerrillGoozner of the Center for Science in the Pubic Interestand Jennifer Washburn of the New America Foundationassert that the CIRM has an opportunity to implementinnovative policies that would address deep flaws in thestatus quo11

Senator Deborah Ortiz (D-Sacramento) has played akey role in widening the discussion on the CIRMrsquosintellectual property policies In October she conveneda full-day legislative hearing to explore policy options12

Her proposed reforms included requirements for bothfinancial returns to the state and affordable pricing13

Maximizing health equity

In order to honor the promises of theProposition 71 campaign and uphold fun-damental principles of health equity theCIRM must adopt policies that maximize

the affordability and accessibility of any medical treat-ments that might result from the research it funds

Concerns about the CIRMrsquos commitment to healthequity policies were expressed forcefully at a March2005 Senate Health Committee hearing by John YuasaHealth Policy Director at the Greenlining Institute ldquoItwould appear from all the indications thus far that thestem cell program is being formed largely to benefit therich at the expense of the poor and ethnic minoritypopulationsrdquo Yuasa said ldquoIn fact it can be seen fromrecent revelations that this program has all the appear-ances of a subsidy program for the wealthy and is asnub at the ethnic minorities of Californiardquo14

To date CIRM leadership has resisted the inclusion ofaffordability and accessibility of stem cell treatments asa key criterion in its policy considerations Its resist-ance has been based on two lines of logic Most oftenCIRM representatives assert that their job is limited toadvancing the science not to ameliorating the defectsof the nationrsquos health care system More recently some

members of the ICOC have argued that any plans toensure affordability and accessibilitymdashhowever mod-estmdashwould exacerbate already excessive expectationsand could do more harm than good15

These arguments are unconvincing Of course the costof medical treatment is a complex topic and depends toan important degree on the particulars of still-to-be-achieved research results But two kinds of policies forwhich the CIRM is responsible will greatly affectwhether stem cellndashbased treatments if they are success-fully developed will be widely affordable and accessible

The first concerns the pricing of any successfully devel-oped stem cell treatments The intellectual propertyarrangements discussed in the previous section willhave a major impact on the price structure of any ther-apies brought to market For example the CIRM couldrequire that any successful therapies developed with itsmoney be made available to the statersquos medical insur-ance programs at reduced or no cost Or it couldrequire grant recipients to set aside a portion of any IPrevenue in an accessibility fund

The second kind of policy that will affect health equityhas so far received little attention It concerns theresearch directions that are prioritized by stem cellresearchers whether funded by the CIRM or from othersources Part of the enthusiasm about stem cell researchhas been based on scenarios of ldquoindividually tailoredrdquotreatmentsmdashthe ldquopersonal repair kitrdquo to which RonReagan Jr referred at the 2004 Democratic Party con-vention16 This prospect assumes that treatments would

D

ldquoIt would appear that the stem cell

program is being formed largely to

benefit the rich at the expense of the

poor and ethnic minority populations

This program has all the appearances

of a subsidy program for the wealthy

and is a snub at the ethnic minorities

of Californiardquo

John Yuasa Greenlining Institute

11


be developed using the technique known as researchcloning or somatic cell nuclear transfer (SCNT)

But treatments based on stem cell lines derived fromcloned embryos would be very expensive Estimates byscientists and biotechnology leaders put the cost at$100000 or more per patient17 Even biotechnologyindustry leaders recognize that this would be impracti-cal ldquoWe donrsquot think it makes sense as a business modelproducing cell therapies for a patient population of onerdquosaid Alan Robins chief scientific officer of BresaGenAnd according to Geron chief executive ThomasOkarma ldquoThe process is a nonstarter commerciallyrdquo18

In contrast to stem cell lines created by researchcloning those derived from embryos that were createdbut not used for fertility purposes would likely cost sig-nificantly less But while research cloning will at bestlead to treatments that would be available only to a tinynumber of wealthy individuals it may turn out to beuseful in basic research This prospect may make itchallenging to evaluate the likely eventual benefits ofcertain particular funding proposals

Nevertheless decision-makers at the CIRM can andshould make affordability accessibility and health equitykey criteria as they chart the basic research directions to besupported with public funds Californians deserve no less

Recommendations

bull In developing policies regarding intellectual property rights the CIRM should involve a diverserange of public-interest stakeholders including advocates for low-income Californians support-ers of intellectual property rights reform and representatives of state government

bull The CIRM should develop and adopt intellectual property policies that ensure financial returnsto the state

bull The CIRM should develop and adopt intellectual property policies that ensure the affordabilityand accessibility of any successfully developed stem cellndashbased treatments

bull The CIRM should prioritize research directed at treatments likely to be affordable to the greatmajority of Californians

12


Although the CIRM isa state agency it hasoften operated withindifference to widelyaccepted norms ofgood governance Ithas been slow in tak-ing many steps neces-sary to build a respon-sible and accountableorganization and its

stewardship of public funds has at times been loose andsloppy It has resisted calls to open key meetings to thepublic relenting only under pressure The role of RobertKlein the central figure in the California stem cellresearch program and the chair of the ICOC has beencalled into question by his financial entanglements withstem cell research advocacy his consistently uncoopera-tive attitude towards the state legislature and revela-tions that he withheld key information from voters dur-ing the Proposition 71 campaign

Building organizational infrastructure

A new state agency must establish an opera-tional foundation before proceeding with itsprogram The CIRM leadership has repeat-edly stumbled on the critical tasks necessary

for building a basic organizational infrastructure

Fundamental decisions about an operating budget anda structure of staff accountability were not considereduntil May 2005 a full six months after the first meetingof the ICOC The versions finally approved inSeptember were incomplete the budget document wasvague and limited to general funding categories andthe organization plan failed to ensure that the CIRMstaff was accountable to the President19 Indeed aDecember New York Times article noted that the ICOC had just then after almost a year asked thePresident ldquoto draw up a plan for how to draw up astrategic planrdquo20

At several junctures the CIRM leadership appeared tobe sacrificing financial responsibility to public rela-tions Two agreements totaling almost $500000 worthof public relations services were among contractssigned without prior approval by the ICOC21 InSeptember the CIRM publicized an announcement ofgrants totaling $40 million to sixteen institutionsdespite the fact that the agency had not yet secured themoney with which to fund these awards22

The CIRMrsquos hiring practices and salaries have alsoraised concerns The majority of the initial CIRM staffwas hired in a manner that circumvented the open andcompetitive application procedures to which all publicand most private institutions subscribe Many weredirectly recruited from the Proposition 71 campaignand given salaries approximately double those in simi-lar positions at typical state agencies23

Organizations representing California communities ofcolor have asked CIRM leadership to put in place poli-cies that set specific goals for diversity in hiring at alllevels and in contracting24 These policies have not beenforthcoming

In February 2005 former United States AssistantSecretary for Health Philip R Lee and public interestattorney Charles Halpern filed a petition addressingmany of these failings CIRM leadership issued aresponse that failed to address in a substantive mannerthe concerns they raised25

Minimizing conflicts of interest

Proposition 71 established an agency withbuilt-in conflicts of interest It specifies thatall members of the CIRMrsquos governing boardthe ICOC represent institutions or con-

stituencies that are likely to seek a share of the $3 bil-lion of public funds authorized by the measure TheICOC includes no voices or perspectives independentof these institutions and constituencies In marked con-trast to this arrangement government boards that over-

Establishing Accountable andResponsible Governance

Accountable andResponsibleGovernance

C-

C

D

see stem cell research in other countries are required toinclude a broad range of stakeholders26

In December 2004 Deborah Burger President of theCalifornia Nurses Association called the compositionof the ICOC ldquoinadequately independent or representa-tive of the broader publicrdquo and said that the ldquooversightcommittee should consist of people who can truly bedeemed independent citizens rather than special inter-ests and corporate representativesrdquo27

The relationship between the ICOC and the institutionsit funds can be seen in the first round of training grantsannounced on September 9 2005 Of the 16 institu-tions that were awarded almost $40 million 14 are rep-resented on the ICOC Viewed another way all but twoof the 17 ICOC members affiliated with an institutioneligible for this round of funding saw their institutionsreceive grants28

In addition to the institutional conflicts of interest writ-ten into Proposition 71 individual members of the ICOChave personal conflicts of interest based on business andfinancial relationships In April 2005 the Center forGenetics and Society released a report revealing thatseven of the 29 ICOC members have significant businessinterests in companies involved in stem cell researchThese relationships detailed in Appendix 3 include sub-stantial equity investments and board memberships29

A notable example is that of ICOC member DavidBaltimore who sits on the board of Cellerant aCalifornia-based company dedicated to the commercial-ization of human stem cell products30 In July Baltimorewatered down a proposed strengthening of the ICOCrsquosconflict of interest policies that was requested by the

Senate in a way that allows him to maintain an equitystake in the company31

The situation is further clouded by the close relation-ship among the ICOC members the research institu-tions that will receive CIRM grants and pharmaceuticalcompanies The Foundation for Taxpayer andConsumer Rights a liberal advocacy group found thatof the 16 institutions awarded CIRM training grants inSeptember 13 have significant links to the pharmaceu-tical industry These links include major funding agree-ments and board members in the employ of pharma-ceutical corporations FTCRrsquos Jerry Flanagan saidldquoVoters were told they would benefit from stem cellresearch but if the drug companies own the treatmentsit will be the top executives and shareholders that willprofitrdquo32

Conflicts of interest are also a concern as they pertainto the ICOC Working Groups that review grants andmake recommendations for funding Reporters andpublic interest researchers discovered conflicts on theICOC because its members are required to publicly dis-close their personal financial interests However underProposition 71 members of the powerful WorkingGroups are exempt from this requirement and theICOC has refused to adopt policies that would removethis exemption

Cooperating with the state legislature

Proposition 71 specifically exempts theresearch it authorizes from ldquoother currentor future state laws or regulationrdquo (italicsadded) It also effectively prohibits the

state legislature from amending the measure in anymanner

13


ldquoThe oversight committee should

consist of people who can truly be

deemed independent citizens rather

than special interests and corporate

representativesrdquo

Deborah Burger President California Nurses Association

ldquoVoters were told they would benefit

from stem cell research but if the

drug companies own the treatments

it will be the top executives and

shareholders that will profitrdquo

Jerry Flanagan Foundation forTaxpayer and Consumer Rights

D

The CIRMrsquos leadership hasfostered an adversarial rela-tionship with California legis-lators As early as December2004 even before he wasappointed chair of the ICOCRobert Klein made it clear hewanted to take full advantageof the exemptions to publicoversight that he had writteninto Proposition 7133

When Senators Deborah Ortiz(D-Sacramento) a prominentsupporter of Proposition 71and George Runner (R-Antelope Valley) called a hear-ing in March 2005 to explore their growing concernsabout the law Klein refused to attend34 When theyintroduced a reform package later that month CIRMleaders instead of opening a dialogue that might haveled to mutually acceptable compromise were adversar-ial to the point of hostility35 They spent $50000 on aprivate lobbyist to help scuttle the reform proposalsmdashan unprecedented step for a state agency36

This posture only serves to strengthen the claim madein lawsuits that the CIRM is operating outside theexclusive control of state governance37

Later when these lawsuits prevented the issuance ofbonds Klein turned to private organizations for high-risk below-market-rate loans as a stopgap measure38

This approach more appropriate for a private biotechstart-up than for a state agency raised further questionsabout potential conflicts of interest

Fostering transparency with open meetings

Proposition 71 exempts the CIRMrsquos threepowerful Working Groups from key publicinterest laws including Californiarsquos openmeetings act CIRM leadership initially resis-

ted calls from public interest groups to adopt a policy ofopen meetings (with a few exceptions universally recog-nized as necessary) CIRM President Zach Hall claimedthat all Working Group activity consisted of ldquoscientificpeer reviewrdquo and should therefore be conducted behindclosed doors39 However Proposition 71 spells out theactivities and functions of the Working Groups and themajority of them are not concerned with peer review

This attitude was perhaps bestexemplified by the first meet-ing of the ICOC the agenda ofwhich had been prepared inclear violation of the statersquosopen meeting law After pub-lic interest attorney CharlesHalpern brought this to theattention of the ICOC and theAttorney General the meetingwas declared an ldquoemergencysessionrdquo and most of the agen-da was tabled40 In his letter tothe ICOC before this meetingHalpern warned the board to

avoid repeating the ldquopromotional phase of Proposition71 which was characterized by hyperbole and wishfulthinking reducing complicated science to disingenuous30-second television spotsrdquo41

In February 2005 Terry Francke general counsel ofCalifornians Aware noted that ldquothe function of theWorking Groups is overwhelmingly a public one andtheir role is traditionally a public one Moreover publicaccess to the Working Groups acts as vital insuranceagainst conflicts of interest and in any event is protect-ed by the California Constitutionrdquo42

After substantial pressure from public interest organiza-tions the ICOC eventually agreed to open WorkingGroup meetings in most cases However some of therules fail to explicitly state the specific reasons forwhich a meeting may be closed And there is still noprocedure that would allow members of the public to

14


ldquo[T]he function of the Working Groups

is overwhelmingly a public one and

their role is traditionally a public one

Moreover public access to the

Working Groups acts as vital insurance

against conflicts of interest and in any

event is protected by the California

Constitutionrdquo

Terry Francke Californians Aware

B

The ICOC must avoid repeating the

ldquopromotional phase of Proposition 71

which was characterized by hyperbole

and wishful thinking reducing

complicated science to disingenuous

30-second television spotsrdquo

Charles Halpern public interest attorney and member

Institute of Medicine

challenge an improperly closed meeting a key provi-sion of Californiarsquos open meeting laws43

Providing responsible leadership

Establishing accountability and responsiblegovernance at the CIRM is largely depend-ent on the integrity of its leadership Anumber of respected people have been

hired in key positions at the CIRM and it is to be hopedthat they will be willing and able to lead the agencytowards the sorts of governance structures that thestem cell research program so urgently needs

But to date ICOC Chair Robert Klein has misused hisauthority in ways that have significantly underminedtrust and confidence His missteps and arrogance havebeen widely noted The editorial page of the SacramentoBee for example has dubbed Klein the ldquoself-appointedczarrdquo of the stem cell research program and a ldquorogueoperatorrdquo44

A multi-millionaire real estate investor Klein was theprimary author of Proposition 71 and chair of the ini-tiative campaign He was the campaignrsquos largest contrib-utor donating more than $3 million loaning anothermillion and providing his corporate offices as cam-paign headquarters45

15


As of January 2006 three states besidesCalifornia have allocated public funds to humanembryonic stem cell research New Jersey wasthe first in the nation to do so with $5 millionin the grant pipeline and $380 million morepledged Connecticut has passed legislationallocating $100 million over ten years and thegovernor of Illinois included a $10 million lineitem in the statersquos most recent budget1

A number of other states have considered sim-ilar programs Supporters of state-funded stemcell research in Florida are working to place aninitiative on the ballot which would set aside$200 million In 2005 the New York and Illinoislegislatures considered bills that would fundthe research at $1 billion levels Several otherlegislatures have voted on measures with small-er price tags2

At the federal level bipartisan support foroverturning President Bushrsquos restrictions on thefederal funding of human embryonic stem cellresearch has grown In May 2005 the Housepassed the Castle-DeGette bill which wouldallow federal funding for research using sur-plus embryos from assisted reproduction proce-dures Many prominent Republicans broke withthe President and voted for it The Senate ver-sion of the bill awaits action and is expected topass but the President has promised a veto3

Notes

1 Kaitlin Gurney ldquoIn a first New Jersey awardsstem-cell grantsrdquo Philadelphia Inquirer(December 17 2005) at httpwwwphillycommldinquirernewslocalstatesnew_jersey13428845htm ldquoGovernor Rell Signs LawEstablishing Stem Cell Research Fund Ban onHuman Cloningrdquo press release (June 15 2005) athttpwwwctgovgovernorrellcwpviewaspQ=294840ampA=1761 Gretchen Ruethling ldquoIllinois toPay for Cell Researchrdquo New York Times (July 132005) at httpwwwnytimescom20050713health13illinoishtml

2 Stacey Singer ldquoGroup Urges $200 million forstem-cell researchrdquo Palm Beach Post (September22 2005) Mike McIntire ldquoWith Eye on RivalsSenator Proposes New York Instituterdquo New YorkTimes (January 17 2005) at httpwwwnytimescom20050117nyregion17stemhtml Paul GoresldquoIllinois looks at $1 billion plan for stem cellresearchrdquo Milwaukee Journal-Sentinel(November 24 2004) at httpwwwjsonlinecombymnewsnov04278364asp

3 Ceci Connolly ldquoFrist Breaks With Bush On StemCell Researchrdquo Washington Post (July 30 2005)at httpwwwwashingtonpostcomwp-dyncontentarticle20050729AR2005072900158html

D

Stem cell politics in the states and in Congress

16


Recommendations

bull Robert Klein should step down as Chair of the ICOC

bull CIRM leadership should adopt and publicly affirm a policy of cooperation rather than confronta-tion with Californiarsquos elected officials and legislators

bull ICOC and Working Group members and their immediate families should be prohibited from hav-ing any financial interest in companies likely to benefit from CIRM activities including pharma-ceutical companies likely to market any successfully developed treatments

bull Hiring and personnel policies should be in line with those of other California state agenciesDiversity should be promoted as a core value of the CIRM and data regarding diversity in hiringand contracting should be made public

bull Working Group members should be required to publicly disclose their personal financial intereststo the same extent currently required of ICOC members

bull Reasons for holding closed meetings should be explicitly stated with adequate public noticeProcedures to allow the public to challenge improperly closed meetings should be adopted

The qualifications for the position of ICOC Chair whichare detailed in the initiative itself are widely acknowl-edged to be closely tailored to Robert Kleinrsquos resumeacuteThough he denied during the campaign that he plannedto take a long-term position at the CIRM the post-elec-tion search for other candidates was perfunctory46

In December 2004 Robert Klein was nominated forICOC Chair by the four elected officials given thatresponsibility by the initiative the Governor theLieutenant Governor the Secretary of State and theTreasurer In the 2002 election cycle Klein had donat-ed a total of more than $175000 in cash and other non-monetary assets to the latter three of these Once Chairone of Kleinrsquos first acts was to introduce a resolutiongranting himself the powers of interim presidentProvisions in the initiative gave the president extraordi-nary power to hire the initial staff of the CIRM circum-venting state civil service and other requirements47

The majority of the staff hired by the CIRM in its firstfour months were people who had previously workedfor the ldquoYes on 71rdquo campaign andor the stem cellresearch advocacy organization established by Kleinimmediately after the election48 That organization theCalifornia Research and Cures Coalition was inessence a re-creation of the ldquoYes on 71rdquo campaign effortIt was initially chaired by Robert Klein and operatedfrom his corporate offices The coalition which laterchanged its name to the Alliance for Stem Cell

Research works to generate support among the publicthe press and key decision makers for stem cell researchand the CIRM49

In February 2005 it was revealed that the campaignretained considerable debt $1 million of which wasowed to Robert Klein This raised the troublingprospect of Klein raising private money to repay him-self while simultaneously serving as chair of a stateagency slated to issue $3 billion in grants50

Robert Klein has pledged to hold neither stocks in bio-medical companies nor interests in real estate that maybenefit from CIRM activities while he serves as Chair ofthe ICOC51 While commendable this move does noth-ing to disentangle the dense web of financial politicaland decision-making relationships that have character-ized the California stem cell research program and itsleadership from the beginning

Taken as a whole the record shows that Robert Kleinhas failed to provide the kind of leadership that wouldenable the CIRM to operate as an effective and account-able public agency For this reason we believe that heshould step down as Chair of the ICOC His departurewould not in itself resolve the many problems thatplague the agency and would do nothing to address theconflicts of interest of other ICOC members But itcould open the door for the responsible leadership thatis a prerequisite for other needed changes

17


Human embryonic stemcell research raises anumber of novel socialand ethical challengesDeriving stem cell linesfrom cloned embryos(rather than fromembryos created but not

used for fertility purposes) is particularly problematicbecause it requires large numbers of womenrsquos eggs andraises the prospect that cloned embryos could be misused

Most countries with stem cell research programs haveestablished comprehensive regulatory structures to setand enforce research standards or are moving rapidlyto do so52 The US has no such regulatory structureand the polarized politics of embryonic stem cellresearch make it unlikely that this will change in thenear term This situation makes it imperative that effec-tive research standards and ethical safeguards be estab-lished in California The CIRM must put in place thehighest standards and require its grantees to abide bythem as a condition of funding

The CIRM has adopted a set of recommended guide-lines developed by the National Academies as its inter-im standards53 While these guidelines are helpful insome key areas they remain inadequate

The National Academies guidelines acknowledge theneed for additional regulation of embryonic stem cellresearch They recommend that institutions conductingsuch research establish their own oversight commit-tees54 But institution-specific committees cannot beexpected to provide the consistency and comprehen-siveness that is needed in a state-wide program

The National Academies guidelines also recognize theneed for a national oversight body But they provide nospecific recommendations about such a body except toassert that it should not be given authority to review spe-cific research protocols or to enforce any of its decisions

What is needed in California and in the nation as awhole are public-sector bodies with the power toestablish and enforce comprehensive regulations thatapply to both publicly and privately funded research

Protecting women who provide eggs forresearch and other research subjects

The risks associated with egg extractionare more serious than most people realizeData on the frequency of serious adversereactions to hormones used in egg extrac-

tion procedures are inadequate but life-threateningreactions and deaths have occurred Media reports oftwo deaths in the United Kingdom surfaced in 2005both women died as a result of egg extraction proce-dures for fertility treatment55

Susan Fogel of the Pro-Choice Alliance for ResponsiveResearch has noted that ldquoUnlike other types of medicalresearch where testing on human subjects occurs onlymuch later in the process and after laboratory experi-ments have indicated that certain safety levels havebeen achieved SCNT research requires that women bethe first guinea pigsrdquo56

Establishing Ethical Safeguardsand Research StandardsEthical safeguards

C+C+

ldquoUnlike other types of medical

research where testing on human

subjects occurs only much later in the

process and after laboratory

experiments have indicated that

certain safety levels have been

achieved SCNT research requires that

women be the first guinea pigsrdquo

Susan Fogel Pro-Choice Alliance forResponsive Research

18


Many womenrsquos health advocates ethicists and healthlaw experts have long opposed suggestions that womenbe paid for providing their eggs for research This prac-tice would almost certainly induce low-income womento put themselves at unnecessary risk

The CIRM and California stem cell researchers shouldtake this issue seriously The stem cell scandal that gen-erated world-wide headlines at the end of 2005 center-ing on the research led by Hwang Woo-Suk and involv-ing lies cover-ups and scientific fraud first came tolight with revelations that the researchers had usedunethical and illegal methods to obtain womenrsquos eggsfor their work57

Some research advocates argue that paying women whoprovide eggs may be necessary to secure the large num-bers of eggs that research cloning would require58 Totheir credit CIRM leadership appears to have acceptedan interpretation of Proposition 71rsquos language that lim-its any payments for women who provide eggs to reim-bursement for direct expenses such as transportationand child care

However several members of the CIRMrsquos research stan-dards Working Group have advocated an interpretationthat would allow CIRM-funded researchers to give eggproviders additional compensation as long as the fundsfor these payments came from a non-CIRM source TheCIRM should reject such a loophole and officiallyaffirm clear rules that limit reimbursement to out-of-pocket expenses

In addition safeguards need to be put in place to ensurethat eggs donated for fertility purposes are not used forresearch without the express permission of the womenwho provided them The CIRM should adopt require-ments about medical care and informed consent thatprotect the health of women who provide eggs andensure that all CIRM-funded researchers adhere tothese rules as a condition of their grants

The protection of research subjects in clinical trials ofstem cellndashbased treatments is another issue of great con-cern Some prominent stem cell researchers are callingfor an accelerated timeline for clinical trials on humansbypassing normal animal studies Yet stem cell studiesare likely to pose greater risks for research subjects thanare many other sorts of clinical trials because of the

novelty of the science involved and the charged politicaland economic atmosphere surrounding the field

The extraordinarily high public profile of stem cell andcloning research has already created pressures for earlypositive results and for accelerating the move to theclinical trial stage These pressures for haste constitutean additional risk factor for research subjects

Preventing reproductive cloning and otherunacceptable applications of stem cell technologies

California is one of 12 states in whichreproductive human cloning is prohibitedby law and Proposition 71 states that theCIRM will not fund that application of

cloning technology But 38 states have no such law andthere is no national law against reproductive cloning59

The creation of clonal embryos is the first key step in theprocess of reproductive cloning the anticipated produc-tion of cloned human embryos for research raises theprospect of their misuse in efforts to create clonedhuman beings Mechanisms to track clonal embryos andprovide secure arrangements for their creation storageand transport would not be difficult to establish and arenecessary to prevent this unethical practice

In addition itrsquos important to note that stem cell tech-niques being developed for widely supported medicaland basic research could also be used for socially unac-ceptable applications These include efforts to createcertain kinds of human-animal chimeras or childrenwho have been genetically ldquoenhancedrdquo with specifiedphysical behavioral or cognitive characteristics Thedevelopment and use of such techniques could openthe door to long-repudiated eugenic practices

The United Kingdom Canada and other countries haveestablished comprehensive structures of regulatoryoversight to ensure that the techniques and skills uti-lized in human stem cell research are not used to createcloned or genetically modified children or unaccept-able human-animal chimeras Unfortunately the CIRMand its research standards Working Group have so farbeen unwilling to acknowledge the risks related to themisuse of cloned embryos and stem cell techniques orto address ways to minimize them

C

19


Recommendations

bull The CIRM should adopt the highest ethical and safety standards for protecting women whoprovide eggs for research and should prevent the emergence of a market in eggs that exploitslow-income women Specifically before research cloning is funded the CIRM should adopt

n requirements that egg extraction procedures be carried out by medical personnelwho are not financially involved with stem cell research since that conflict of inter-est could create pressures that would lead to unsafe practices

n protocols requiring that women receive follow-up medical care that would allowtimely treatment of any developing adverse reactions

n provisions for covering the costs of treating any adverse reactions caused by eggextraction since some women who provide eggs may not be insured or may haveinsurance policies that do not cover experimental procedures

n safeguards to ensure that eggs donated for fertility purposes are not used forresearch without the express permission of the women who provided them

n an official position affirming that women who provide eggs are to be reimbursedonly for direct out-of-pocket expenses and

n requirements that all CIRM-funded researchers agree to these regulations and pro-tocols as a condition of their grant awards

bull The CIRM should adopt the highest ethical and safety standards for protecting research subjects in clinical trials and exercise great caution in the face of any pressures for early clin-ical trials

bull The CIRM should adopt policies preventing the misuse of clonal embryos in efforts to producecloned or genetically modified human beings It should establish a system of tracking clonalembryos and should require researchers it funds to sign agreements stating that they will notuse the techniques they develop with public funding to assist efforts to produce cloned or genet-ically modified humans or unacceptable human-animal chimeras in California or elsewhere

20


The CIRMrsquos first year of operation as a state agency hasbeen a great disappointment While some of its difficul-ties may be ldquostart-uprdquo problems that might be expectedin any effort this large the greater bulk are the result ofnumerous missteps and misjudgments resistance tolegislative and public oversight and a tendencytowards arrogance in the face of criticism

We believe it is incumbent upon the CIRMrsquos staff andboard to enter the institutersquos second year with a newspirit one that acknowledgesmdashin deeds as well aswordsmdashthe need for transparency accountability andpublic oversight

If all goes according to the CIRMrsquos plans it will soonbegin issuing many millions of dollars in grants forembryonic stem cell research Some of these grants willlikely fund the cloning of human embryos and thegenetic modification of stem cells in order to derivestem cell lines with specific genetic characteristics Theintent of course is that new lines of embryonic stemcells will advance research on degenerative diseases andchronic disorders and that the knowledge derived fromthese investigations will provide the basis for new treat-ments and perhaps even cures

But the creation of clonal and genetically modifiedhuman embryos raises unique ethical and regulatoryissues The CIRMrsquos grants are likely to mark the first timein our nationrsquos history that cloned human embryos willbe publicly underwritten and managed and the CIRMwill face regulatory challenges never previously con-fronted by any other public body in the United States

During the coming year the CIRM will need to provideanswers to a range of novel questions about the respon-sible regulation of the stem cell and cloning research itfunds These questions include

bull What mechanisms controls and agreements withgrantees will ensure that neither cloned embryos nortechniques developed with CIRM funding are mis-used in efforts to produce a cloned or geneticallymodified child

bull What rules protocols and agreements with granteeswill protect the health of women who provide eggsfor research and prevent the emergence of a marketin eggs that exploits economically vulnerablewomen What are the CIRMrsquos and the statersquos respon-sibilities for any ill-health effects on women whoprovide eggs for research or any adverse effects onsubjects in clinical trials

bull What are the appropriate limits to the genetic mod-ification and use of human stem cells

bull What are the appropriate guidelines and limits forthe creation of chimeric animal-human embryos

Other questions raised by Californiarsquos stem cell researchprogram appear to be more conventional But they takeon a unique sharpness because the CIRMrsquos funds wereallocated by a popular vote that was based on claims ofmajor health and fiscal benefits made by research advo-cates Such questions include

bull What intellectual property agreements or otherarrangements will accelerate the research anddevelopment of treatments while providing thepromised public benefit of revenue returns to thestate

bull What intellectual property arrangements willensure that any successfully developed treatmentsare affordable and thus accessible to the public

bull What funding and research guidelines will permitthe open-ended investigations required for newdiscoveries while maximizing efforts likely to pro-vide the most accessible benefits in treatments andtherapies

bull What steps will the CIRM take to cooperate withelected legislators minimize the conflict-of-inter-est dynamics built into Proposition 71 provideresponsible leadership and operate as a well-man-aged state agency

Conclusion Key Issues in theComing Year

Many of the most critical issues need to be discussedand resolved in the coming few months before theCIRM allocates its first research grants Others willneed to be addressed as the funding and science getunderway

Dishearteningly the CIRMrsquos performance over the pastyear in similar policy deliberations has been decidedlydisappointing But Californiarsquos publicly funded stemcell research program still has an opportunity to trans-

form itself into a model for the rest of the country andthe world The CIRM can set as a top priority the estab-lishment of responsible regulation and effective over-sight of the powerful new technologies whose develop-ment it hopes to fund

Only if the CIRM puts effective regulations and over-sight in place will it be able to ensure that responsiblestem cell research and the public interest can move for-ward together

21



bull Proposition 71 passes bull Controversies concerning

accountability and profits followimmediately

bull ldquoStem Cell Firms Bet on Big Payoffrdquo Los Angeles Timesbull ldquoDivvying Up The Stem Cell Bonanzardquo Business Weekbull ldquoCaliforniarsquos New Stem-Cell Initiative Is Already Raising Concernsrdquo

New York Times

NOV60

DEC61bull All four elected officials charged

with nominating a chair for theICOC choose Robert Klein

bull Public interest attorney CharlesHalpern notifies Attorney Generalthat agenda of first ICOC meetingviolates Californiarsquos open meetinglaw most of the agenda is tabled

bull ldquoThe Legislature is not neededrdquo mdash Robert Klein responding to SenOrtizrsquos talk of reform

bull ldquoControversy embroils stem cell panelrdquo Sacramento Beebull ldquoProp 71rsquos fine print contains surprisesrdquo San Francisco Chroniclebull ldquolsquoCoronationrsquo of committee head on stem cell funds disturbs somerdquo

San Diego Union Tribunebull ldquoEditorial Proposition 71 needs reformrdquo San Francisco Examiner

bull At second ICOC meeting Klein isunanimously approved as interimpresident of the CIRM

bull ldquoEditorial Stem cell panel must show accountability to the publicrdquoSan Jose Mercury News

bull ldquoBumpy start for stem cell programrdquo San Francisco Chronicle bull ldquoStem cell panelists show holdings Economic reports leave some

observers uneasyrdquo San Jose Mercury News

JAN62

FEB63

MARCH64

bull Proposition 71 campaign reportsdebt of over $6 million including$1 million to Klein himself

bull Former US Asst Sec for HealthPhilip R Lee and public interestattorney Halpern file petition withthe ICOC calling for reforms

bull ldquo5 with Prop 71 campaign land jobs at new instituterdquo San Diego Union Tribune

bull ldquoNew criticism for stem cell program Public health expert calls formore public oversight lower salariesrdquo San Francisco Chronicle

bull Senators Deborah Ortiz (D) andGeorge Runner (R) hold hearing toexplore concerns about the lawKlein refuses to attend

bull Senators Ortiz and Runner intro-duce reform package

bull ldquoRobert Klein II the self-appointed czar of Californiarsquos quasi-public$3 billion stem cell research program is facing serious challengesthese daysrdquo mdashSacramento Bee editorial

bull ldquoManagement issues plague distribution of $3 billion in state stemcell research fundrdquo Los Angeles City Beat

bull ldquoStem cell institute leader in the hot seatrdquo San Diego Union Tribune

Appendix 1 Timeline

Key QuotesHeadlinesKey Events

2005

bull Research by the Center forGenetics and Society revealsseven ICOC members have signif-icant business relationships withcompanies involved in stem cellresearch

bull ldquoStem cell panel facing allegations of conflictrdquo San Diego UnionTribune

bull ldquoCelling out The directors of stem cell institute have direct ties tobiotech firms that stand to gainrdquo San Francisco Bay Guardian

bull ldquoStem-cell research clashes Senate panel raises bar on conflict-of-interest rulesrdquo San Jose Mercury News

APR65

2004

Immediately after the passage of Proposition 71 questions andconcerns about the initiative and its implementation began toappear in news articles columns and editorials in Californiarsquosmajor newspapers including those that had endorsed it beforethe election By spring 2005 most major newspapers in the state

had published editorials raising concerns about the Californiastem cell research program and news headlines critical of it hadbecome routine This timeline shows key events sinceNovember 2004 and related headlines and quotes from pub-lished news articles and editorials

22

23


MAY66bull CIRM chooses to site its headquar-

ters in San Francisco whichoffered an estimated $17 million ofsubsidies including free rent

bull ICOC votes to oppose most of theOrtiz-Runner reform packageCIRM hires a private lobbyist for$50000 to help scuttle the pro-posed reforms

bull CIRM legal analysis suggests thattax-exempt bonds may not be ableto be used for research that willgenerate a return to the state

bull CIRM ldquoshould get behind legislation by state Sen Deborah OrtizD-Sacramento to enact stricter conflict-of-interest rules on theresearch funded by Proposition 71rdquo mdashSan Jose Mercury Newseditorial

bull ldquoThis isnrsquot Kleins or his boards $3 billionmdashitrsquos the publicrsquos Andpublic oversight is one of the best ways to guard against publicmoney going astrayrdquo mdashLos Angeles Times editorial

bull Robert Klein is ldquoRogue operatorrdquo mdashSacramento Bee editorial

bull Amid reports of internal dissensionCIRM secures a $5 million privategrant to maintain operations

bull ldquoWe are getting killed by the press We are getting killed by theLegislature We are getting killed by people who support usrdquo mdashICOC member Jeff Sheehy in a Sacramento Bee column

bull ldquoStatersquos stem cell board opposes proposal for increased oversightrdquoSan Francisco Chronicle

JUNE67

JULY68

AUG69

SEPT70

OCT71

NOV72

DEC73

bull ldquoStem cell institute considers where to startrdquo San FranciscoChronicle

bull ldquoTax law casts doubt on stem cell royalties State may not reapbillions promised to voters last fallrdquo San Francisco Chronicle

bull A special committee of theCalifornia Council for Science andTechnology recommends thatCIRM leave all profits withresearchers and businesses (nonefor the taxpayers) and notes thatbenefits are at least 20 years away

bull ICOC discovers that CIRM hasimproperly awarded contractsworth hundreds of thousands ofdollars without its approvalincluding two agreements for public relations totaling almost$500000

bull ldquoCalifornia Stem-Cell Agency Gets Off to Inauspicious StartrdquoWall Street Journal

bull ldquoTaxpayers unlikely to get quick stem cell windfallrdquo San DiegoUnion Tribune

bull Editorial ldquoStem cell follies Crank up the spin machinerdquoSacramento Bee

bull Klein admits knowing of the taxcomplications during the campaign

bull ldquoReport finds stem cell windfall assumptions unrealisticrdquo San Diego Union Tribune

bull Editorial ldquoStem cell funding is venture capitalrdquo San FranciscoExaminer

bull ICOC approves $40 million inldquotraining grantsrdquo despite havingno funds Of the 16 recipient insti-tutions 14 are represented on theICOC

bull ldquoTheir own rules mean multimillion-dollar decisions are basedon two-page memosrdquo mdashSacramento Bee editorial

bull ldquoWho will benefit more consumers or drug firmsrdquo San JoseMercury News

bull ldquoStem cellrsquos shell gamerdquo Capitol Weekly

bull The San Francisco Chroniclereveals that Klein knew during thecampaign of the conflict betweentax exempt bonds and returns tothe state

bull ldquoId want to go back and review this areardquo mdashRobert Klein whenasked why he didnrsquot tell economic analysts about the tax compli-cations during the campaign in a Sacramento Bee column

bull ICOC adopts interim intellectualproperty policy with only a weakpreference for affordable therapies

bull ldquoI liken it to the Iraq thinkingmdashwe won the war and didnrsquot knowwhat to do afterwardrdquo mdashPaul Berg ICOC substitute member

24


The CIRM is governed by a twenty-nine member gov-erning board the Independent Citizensrsquo OversightCommittee (ICOC) It is composed of officers from pub-lic and private universities and nonprofit research cen-ters representatives of biotechnology corporations anddisease-specific patient advocates Twenty-seven mem-bers are appointed by California elected officials andchancellors of the University of California system whoselect them on the basis of the institutional or patientadvocacy affiliations specified by Proposition 71 Thechair and vice-chair are then elected by these membersfrom candidates nominated by the elected officials

The initial members of the ICOC were selected inDecember 2004 The biographical information belowwas compiled from the CIRM website press releasesannouncing the appointments the Fair PoliticalPractices Commission Form 700s filed by the membersand news reports

Robert Klein Chair President of Klein FinancialCorporation a real estate investment banking consult-ing company President of Klein Financial Resources areal estate development company and Chairman of theldquoYes on 71rdquo campaign Klein was the chief force behindProposition 71 and one of its chief authors He donatedmore than $3 million to the campaign and his compa-ny donated another $700000

Edward Penhoet Vice-Chair Chiron co-founder andboard member Alta Partners principal Renovis co-founder and board chair Zymogenetics board memberGordon and Betty Moore Foundation president

David Baltimore California Institute of Technologypresident Cellerant co-founder and board memberAmgen co-founder and board member BB Biotechboard member FasterCuresThe Center for AcceleratingMedical Solutions board member

Robert Birgeneau UC Berkeley Chancellor

Keith Black Cedars-Sinai Medical Center Director ofDunitz Neurosurgical Institute

Susan Bryant UC Irvine Dean of School of BiologicalSciences

Marcy Feit ValleyCare Health System president and CEO

Michael Friedman City of Hope president MannKindboard member

Michael Goldberg Genomic Health board memberZyomyx board member iKnowMed Systems boardmember Cemaphore board member eHealthInsuranceboard member

Brian Henderson University of Southern CaliforniaKeck School of Medicine Dean

Edward Holmes UC San Diego School of MedicineDean

David Kessler UC San Francisco School of MedicineDean

Sherry Lansing University of California Regent StopCancer founder and board chair

Gerald Levey UC Los Angeles David Geffen School ofMedicine Dean

Ted Love Nuvelo president and CEO

Richard Murphy Salk Institute president

Tina Nova Genoptix president and CEO ArenaPharmaceuticals board member

Philip Pizzo Stanford University School of MedicineDean

Claire Pomeroy UC Davis School of MedicineAssociate Dean

Francisco Prieto American Diabetes AssociationSacramento-Sierra chapter president

John Reed Burnham Institute president StratageneHolding Corporation board member Isis Pharmaceuticalsboard member Idun Pharmaceuticals board member

Joan Samuelson Parkinsonrsquos Action Network president

Appendix 2 The IndependentCitizens Oversight Committee

25


David Serrano-Sewell National Multiple SclerosisSociety volunteer City of San Francisco deputy cityattorney

Jeff Sheehy UC San Francisco AIDS Research InstituteDirector of Communications

Jonathan Shestack Cure Autism Now founder vicepresident secretary and treasurer

Oswald Steward UC Irvine Reeve-Irvine ResearchCenter for Spinal Cord Injury Chair and Director

Leon Thal UC San Diego Alzheimerrsquos Disease ResearchCenter Director Department of Neurosciences Chair

Gayle Wilson Gilead Sciences board member (Wilsonrsquosresignation from the ICOC was announced on January3 2006)

Janet Wright American College of Cardiology

26


The California stem cell research program is compro-mised by two sorts of conflicts of interest Proposition71 which established the California Institute forRegenerative Medicine (CIRM) built conflicts of inter-est into the structure of the new agency The proposi-tion mandates that at least half of the CIRMrsquos governingboard the Independent Citizensrsquo Oversight Committee(ICOC) must represent institutions that are likely toconduct stem cell research

In addition to these built-in institutional conflictssome members of the ICOC have personal conflicts ofinterest Initial research by the Center for Genetics andSociety has revealed that seven of the twenty-nineICOC members have significant business relationshipswith companies involved in stem cell research Theserelationships include substantial equity investmentsand board memberships

CGS has compiled summaries of the backgrounds andfinancial interests of seven ICOC members who haveinvestments or leadership positions in companies thatare currently or have in the past been involved withstem cell research Worth of stock ownership is report-ed on Form 700s that were submitted upon appoint-ment to the ICOC74

ICOC Vice-Chair Edward Penhoet reported owningmore than $1 million dollars in stock in three of thebiotechnology companies on whose boards he sits

bull One Zymogenetics described the work of itsldquostem cell biologistsrdquo and its ldquoDirector of StemCell Biologyrdquo in a press release75

bull Penhoet is founder and board chair of Renoviswhose exclusive licensee AstraZeneca uses stemcells in their research programs76 Also on theeight-member Renovis board of directors is JohnWalker who sits on the board of Geron the largestand most prominent stem cell corporation77

bull Penhoet is founder and board member of ChironSeveral years ago Chiron participated in stem cellstudies78

In January 2005 Penhoet told the San Jose MercuryNews ldquoIrsquom not aware that any investment I have or anyboard that I serve on is involved in stem cell researchrdquoThe news report continued ldquoShould that change hesaid he would resign from the company board and sellany holdingsrdquo79

David Baltimore sits on the board of Cellerant a pri-vately held California-based company dedicated to thecommercialization of human stem cell therapiesBaltimore did not report how much equity he holds inthe company

Baltimore also serves on the board of Amgen theworldrsquos largest biotechnology corporation and hasbetween $100000 and $1 million dollars invested in it

Amgen has a strategic relationship with ViaCell a stemcell company As recently as January 2005 a headline atForbescom read ldquoAmgen Profits From Stem Cell IPOrdquoIn exchange for a $20 million dollar stake in ViaCellAmgen granted ViaCell a worldwide license to stem cellgrowth factors developed by Amgen FurthermoreAmgen retains an option to collaborate with ViaCell onldquoproduct or products that incorporate an Amgengrowth factor or technologyrdquo80

In addition to Baltimore Edward Frizky is on the boardof Amgen Frtizky also has a seat on the board of Geronthe largest and most prominent stem cell corporation

Tina Nova is the founder and CEO of Genoptix Incwhich develops lasers applicable in stem cell isolation81

Gayle Wilson owns between $100000 and $1 millionof stock in the biotech company Boston ScientificCorp which researches and is commercializing stemcell therapies82

Appendix 3 Personal Conflictsof Interest on the ICOC

This report was originally published in April 2005 It was amended in September 2005 to include the information onCellerant

27


Keith Black owns between $10000 and $100000 ofstock in Genentech which conducts stem cellresearch83

John Reed serves on the board of Stratagene HoldingCorporation which utilizes stem cell research in thedevelopment of its products84

Brian Henderson owns between $2000 and $10000 ofstock each in Genentech and Medtronic Both compa-nies engage in stem cell research85

Other biomedical industry involvements

Other ICOC members have significant investments or

leadership positions in the broader biomedical industryThese also raise concerns about conflicts of interest forseveral reasons

bull Proposition 71 funds are not restricted to stem cellresearch In fact the ICOC can decide to allocatefunds to any other kind of biomedical research

bull Any discoveries made using CIRM funds will belicensed to companies for commercializationThese are likely to be pharmaceutical and biomed-ical corporations

bull A growing number of traditional pharmaceuticaland biomedical corporations are now engaging in

28


1 The plaintiffs in the lawsuits are religious conservativeswho are opposed to embryonic stem cell research inprinciple and anti-tax conservatives who object to theuse of state funds for a program such as the CIRM Butthe arguments they raise in the lawsuits concern thegovernance of state agencies and legislative control ofpublic funds In November 2005 a group of pro-choicescholars and others filed an amicus brief in support ofthe suits The amicus brief cites ldquo1) lack of exclusivestate control 2) impermissible conflicts of interest 3)misrepresentations of research to be funded and 4)misrepresentations on financial returns to CaliforniardquoThe amicus brief is online at httpwwwgenetics-and-societyorgpoliciescaliforniaamicus20051117htmlAlso see Marisa Lagos ldquoFuture of statersquos stem cellagency in courtrsquos handsrdquo San Francisco Examiner(November 20 2005) athttpwwwsfexaminercomarticles20051120news20051119_ne02_stemtxt

2 Kathay Feng Steven Blackledge ldquoOversight is criticalfor confidence in stem-cell researchrdquo San FranciscoChronicle (June 30 2005) httpwwwsfgatecomcgi-binarticlecgifile=chroniclearchive20050630EDGOODGATU1DTL

3 For example the co-chair of the campaign MichaelGoldberg is now on the ICOC (seehttpwwwmdvcomteam_goldberghtm) Two otherICOC members Joan Samuelson and Keith Blackappeared in television ads (seehttpwwwyeson71comtv_radiophp) Several otherspublicly endorsed the measure Among the CIRM staffseveral of the early hires were directly recruited fromthe campaign See Terri Somers ldquo5 with Prop 71campaign land jobs at new instituterdquo San Diego Union-Tribune (February 4 2005)httpwwwsignonsandiegocomnewsstate20050204-9999-1n4stemcellhtml

4 The campaignrsquos standard presentation can be viewed athttpwwwyeson71comdocumentsstemcellpresentationpdfSee also the economic analysis sponsored by thecampaign Laurence Baker and Bruce Deal ldquoEconomicImpact Analysis Proposition 71 California Stem CellResearch and Cures Initiativerdquo (September 14 2004) athttpwwwyeson71comdocumentsProp71_Economic_Reportpdf and the Official Voter Information Guide athttpwwwsscagovelectionselections_viguide_pg04htm

5 In one ad for example Jeffrey Bluestone of the UC SanFrancisco Diabetes Center says ldquoWhen a 7-year-old girlcomes up to me and shersquos scared and she says lsquoWillstem cells be an answer for me Will they be a cure formersquo Irsquom absolutely confident in saying that lsquoThis willhappenrsquordquo Other researchers featured in ads include

Irving Weissman Lawrence Goldstein Paul Berg andKeith Black Some of the campaign ads remain online athttpwwwyeson71orgtv_radiophp

6 In the campaign-sponsored economic analysis Bakerand Deal summarize ldquoProposition 71 is capable ofpaying for itself during the payback period alone withthe possibility of continuing to generate billions ofdollars in revenues and savings for the State ofCalifornia for decades after thatrdquo (Supra note 4 p 2)

7 Proposition 71 has a clause titled ldquoPatent Royalties andLicense Revenues Paid To The State of Californiardquostating that ldquoThe ICOC shall establish standards thatrequire that all grants and loan awards be subject tointellectual property agreements that balance theopportunity of the state of California to benefit from thepatents royalties and licenses that result from basicresearch therapy development and clinical trials withthe need to assure that essential medical research is notunreasonably hindered by the intellectual propertyagreementsrdquo See httpwwwyeson71cominitiativephpFor campaign promises see note 5

8 ldquoState deserves a share of stem-cell benefitsrdquo SanFrancisco Chronicle (December 9 2004) athttpsfgatecomcgi-binarticlecgifile=chroniclearchive20041209EDGSVA88PD1DTL

9 For example see the agendas of the two meetings of theCIRMrsquos IP task force on October 25 and November 222005 at httpwwwcirmcagovmeetings20051010-25-05asp andhttpwwwcirmcagovmeetings20051111-22-05asp

10 The interim report Policy Framework for IntellectualProperty Derived from Stem Cell Research in California isat httpwwwccstusccstpubsIPIP20InterimpdfThe committee members are listed athttpwwwccstusccstprojectsipiplisthtml

11 At the Joint Assembly Health and Senate hearings onldquoImplementation of Proposition 71 Options forHandling Intellectual Property Associated with StemCell Research Grantsrdquo (October 31 2005) MerrillGoozner of the Center for Science in the Public Interestoutlined a patent pool for CIRM-funded discoveriesand Jennifer Washburn of the New America Foundationdiscussed the benefits of separating the management ofintellectual property rights from the educationalinstitutions See httpwwwsenatecagovftpSENCOMMITTEESTANDINGHEALTH_homePROP_71_IP_TRANSCRIPTdoc

12 Ibid

13 ldquoSenators Runner and Ortiz Introduce LegislativePackage to Protect Publicrsquos Investment In Stem CellResearchrdquo press release (March 16 2005) at

Endnotes

29


httprepublicansencagovnews17pressrelease3283asp

14 See the transcript of the Joint Assembly Health andSenate hearings on ldquoImplementation of Proposition 71the Stem Cell Research and Cures Actrdquo (March 9 2005)at httpwwwsencagovftpSENCOMMITTEESTANDINGHEALTH_homePROP_71_OVERSIGHT_TRANSCRIPTdoc

15 Both arguments were made at the second meeting of theIP task force (November 22 2005) transcript availableat httpwwwcirmcagovtranscripts

16 The text of his July 27 2004 speech is athttpwwwpbsorgnewshourvote2004demconventionspeechesreaganhtm

17 Peter Mombaerts ldquoTherapeutic cloning in the mouserdquoProceedings of the National Academy of Sciences(September 30 2003) The author estimated the costsfor a clonally derived human stem cell line to be at least$100000 to $200000 for just the human eggs

18 Denise Gellene ldquoClone Profit Unlikely TheTechnologyrsquos Commercial Viability Faces ManyHurdlesrdquo Los Angeles Times May 10 2002 athttpwwwgenetics-and-societyorgresourcesitems20020510_latimes_gellenehtml

19 See the Presidentrsquos reports of the April 7 and September9 meetings of the ICOChttpwwwcirmcagovmeetings20050404-07-05aspand httpwwwcirmcagovmeetings20050909-09-05asp A more detailed but still inadequatebudget was approved on December 6 2005 Seehttpwwwcirmcagovmeetings20051212-06-05asp

20 Andrew Pollack ldquoCaliforniarsquos Stem Cell Program IsHobbled but Staying the Courserdquo New York Times(December 9 2005) at httpwwwnytimescom20051210business10stemhtml

21 See the items and the discussion at the July 12 ICOCmeeting httpwwwcirmcagovmeetings20050707-12-05asp andhttpwwwcirmcagovtranscriptspdf07-12-05pdfRecent contract totals are athttpwwwcirmcagovmeetingspdf20050909090905_item_13bpdf

22 ldquoICOC Approves First Stem Cell Grants In CaliforniardquoCIRM press release (September 9 2005) athttpwwwcirmcagovpressreleases20050909-09-05_iiasp

23 See Terri Somers ldquo5 with Prop 71 campaign land jobsat new instituterdquo San Diego Union-Tribune (February 42005) at httpwwwsignonsandiegocomnewsstate20050204-9999-1n4stemcellhtml See alsothe ldquoCIRM Staffing Updaterdquo distributed at the February3 ICOC meeting

24 The Greenlining Institute made these requests in aFebruary 7 2005 letter to Robert Klein cited in thebackground paper for the March 9 2005ldquoImplementation of Proposition 71 the Stem CellResearch and Cures Initiativerdquo Legislative hearings athttpwwwsenatecagovftpSENCOMMITTEE

STANDINGHEALTH_homePROP_71_OVERSIGHT_BACKGROUNDdoc

25 The Lee-Halpern petition is at httpwwwgenetics-and-societyorgpoliciescalifornialeehalpern20050216icochtmlThe response from the CIRM is at httpwwwgenetics-and-societyorgpoliciescalifornialeehalpern20050318responsehtml

26 In the United Kingdom for example the Chair DeputyChair and at least half of the 21 members of its HumanFertilisation and Embryology Authority can neither bedoctors nor scientists involved in related research SeehttpwwwhfeagovukAboutHFEAFAQs In Canadathe Assisted Human Reproduction Act passed in 2004requires the governing board it establishes to includeethicists womenrsquos health representatives and legalscholars among others SeehttplawsjusticegccaenA-1342389html

27 California Nurses Association ldquoCalifornia Nurses AssnCalls for Added Public Protections as Prop 71 PolicyBoard Convenesrdquo press release (December 17 2004) athttpwwwdatawarehousingsurvivalcomcontentview22322

28 The first round of grants is listed on the CIRM pressrelease ldquoICOC Approves First Stem Cell Grants inCaliforniardquo (September 9 2005) athttpwwwcirmcagovpressreleases20050909-09-05_iiasp Note that the Gladstone Institute ispart of UC San Francisco and that Sherry Lansing is aregent of the UC system The ICOC members are listedin Appendix 2 there is more detailed information at httpwwwgenetics-and-societyorgpoliciescaliforniaicochtml

29 See the report by the Center for Genetics and Society onpotential conflicts of interest on the ICOC athttpwwwgenetics-and-societyorgpoliciescaliforniaconflictshtml

30 Ibid

31 See the transcript of the July 12 2005 meeting of theICOC in Irvine athttpwwwcirmcagovtranscriptspdf07-12-05pdf

32 Foundation for Taxpayer and Consumer Rightsdocuments can be viewed athttpwwwconsumerwatchdogorghealthcareprpostId=220amppageTitle=Prop+7127s+Stem+Cell+Oversight+Committee+Rife+With+Conflicts+of+Interestand httpwwwconsumerwatchdogorghealthcareprpostId=5209amppageTitle=13+of+16+Stem+Cell+Grantees+Have+Conflicts-of-Interest+With+Drug+and+BioTech+Companies3B+

33 Bernadette Tansey ldquoProp 71rsquos fine print containssurprisesrdquo San Francisco Chronicle (December 8 2004)at httpwwwsfgatecomcgi-binarticlecgif=ca20041208MNGPBA8DPN1DTL

34 Terri Somers ldquoStem cell institute leader in the hot seatrdquoSan Diego Union Tribune (March 10 2005) athttpwwwsignonsandiegocomnewsstate20050310-9999-1n10stemshtml

30


35 Carl T Hall ldquoStem cell research embroiled in DCSacramento tusslesrdquo San Francisco Chronicle (May 242005) httpsfgatecomcgi-binarticlecgifile=ca20050524BAGTFCTOKS1DTL

36 First reported in David Jensen ldquoThe $10000-a-MonthStem Cell Lobbyistrdquo California Stem Cell Report (May 52005) at httpcaliforniastemcellreportblogspotcom2005_05_01_californiastemcellreport_archivehtml Thetotal amount can be seen in CIRM contract summariessuch as at httpwwwcirmcagovmeetingspdf20050909090905_item_13bpdf

37 Supra note 1

38 The bridge financing was approved as bond anticipationnotes by the Finance Committee on May 9 2005online at httpwwwcirmcagovmeetings20050505-09-05asp and discussed at several of the ICOCmeetings in the latter half of 2005 The plan forobtaining below-market rates was discussed at the July12 2005 meeting See the meeting transcript athttpwwwcirmcagovtranscriptspdf200507-12-05pdf

39 This resistance is best seen in Dr Hallrsquos statements atthe joint Assembly Health and Senate hearings onldquoImplementation of Proposition 71 the Stem CellResearch and Cures Actrdquo (March 9 2005) athttpwwwsencagovftpSENCOMMITTEESTANDINGHEALTH_homePROP_71_OVERSIGHT_TRANSCRIPTdoc

40 Carl Hall ldquoStem cell panel scrubs its agenda Groupwonrsquot take up substantive issues after warning on open-government rulesrdquo San Francisco Chronicle (December17 2004) at httpsfgatecomcgi-binarticlecgif=ca20041217BAGA4AD74H19DTL

41 Letter from Charles Halpern to the members of theICOC (December 15 2004) at httpwwwgenetics-and-societyorgpoliciescaliforniahalpern20041215icochtml

42 Terry Francke ldquoLetter Supporting Lee-HalpernPetitionrdquo (February 18 2005) at httpcalawareorgnewsweekly_detail_printjsparticle_id=535

43 For example see the meeting policy of the ResearchStandards Working Group athttpwwwcirmcagovmeetings20050606-06-05asp

44 ldquoEditorial Cell breakrdquo Sacramento Bee (March 6 2005)at httpwwwgenetics-and-societyorgnewsdispaspid=723 and ldquoEditorial Rogue operatorrdquoSacramento Bee (May 22 2005) at httpwwwgenetics-and-societyorgnewsdispaspid=785

45 Dan Morain ldquoSchwarzenegger a Big Fundraiser in2004rdquo Los Angeles Times (February 1 2005) LeonardAnderson ldquoCalifornia Stem Cell Backer Gets FinalNominationrdquo Reuters (December 15 2004) Donationsto the Yes on 71 campaign are online at httpcal-accesssscagovCampaignCommitteesDetailaspxid=1260661ampsession=2003ampview=received

46 For example see Connie Bruck ldquoHollywood ScienceShould a Ballot Initiative Determine the Fate of Stem-Cell Researchrdquo The New Yorker (October 18 2004) athttpwwwnewyorkercomfactcontent041018fa_fact6

47 See Robert Kleinrsquos contributions to Phil Angelides CruzBustamante and Steve Westly at httpcal-accesssscagovCampaignCommitteesDetailaspxid=1239171ampview=contributionsampsession=2003 See also Terri SomersldquolsquoCoronationrsquo of committee head on stem cell fundsdisturbs somerdquo San Diego Union Tribune (December 152004) at httpwwwsignonsandiegocomuniontrib20041215news_1n15kleinhtml

48 The staffing was detailed at the February 3 2005 ICOCmeeting in San Diego whose agenda and transcript areat httpwwwcirmcagovmeetings20050202-03-05aspand httpwwwcirmcagovtranscriptspdf02-03-05pdfKlein became interim chair at the January 6 2005ICOC meeting in Los Angeleshttpwwwcirmcagovmeetings20050101-06-05asp

49 In December 2004 the new coalition organized a two-day ldquobest practicesrdquo session with the NationalAcademies In January it was given responsibility fororganizing the second meeting of the ICOC and itorganized four public forums throughout California Seehttpwwwcuresforcaliforniacom See also LauraMecoy ldquoStem cell panel vows opennessrdquo SacramentoBee (January 7 2005) at httpwwwgenetics-and-societyorgnewsdispaspid=692

50 The campaign debt was disclosed in Dan MorainldquoSchwarzenegger a Big Fundraiser in 2004rdquo Los AngelesTimes (February 1 2005) The California Secretary ofStatersquos Campaign Finance Activity Report showed onDecember 23 2005 that the debt had not yet beenrepaid at httpcal-accesssscagovCampaignCommitteesDetailaspxid=1260661ampsession=2005

51 Carl T Hall ldquoGovernorrsquos choice for stem cell chairmanrdquoSan Francisco Chronicle (December 14 2004) athttpsfgatecomcgi-binarticlecgif=ca20041214MNGL7ABKFR1DTL

52 See the database maintained by Global Lawyers andPhysicians for Human Rights athttpwwwglphrorggeneticgenetichtm

53 The interim CIRM regulations were adopted November2 2005 and are at httpwwwcirmcagovguidelinespdfInterim_Guidelinespdf

54 See the National Academies of Sciences Guidelines forHuman Embryonic Stem Cell Research Washington DC2005 at httpwwwnapedubooks0309096537html

55 See ldquoUK woman killed by rare IVF riskrdquo BBC News(April 13 2005) at httpnewsbbccouk1hihealth4440573stm and ldquolsquoIVF treatment killed my daughterrsquordquoBBC News (June 30 2005) athttpnewsbbccouk1hihealth4635261stm

56 Press release from the Pro-Choice Alliance forResponsible Research Our Bodies Ourselves and theCenter for Genetics and Society ldquoUnregulated Stem CellResearch May Put Womenrsquos Health At Riskrdquo (March 72005) at httpwwwgenetics-and-societyorgresourcescgs20050307_cirm_presshtml

57 Rick Weiss ldquoUS Scientist Leaves Joint Stem CellProjectrdquo Washington Post (November 12 2005) at

31


httpwwwwashingtonpostcomwp-dyncontentarticle20051111AR2005111101836html

58 See for example the transcript of the December 1 2005meeting of the research standards Working Group athttpwwwcirmcagovtranscriptspdf200512-01-05pdf

59 The National Conference of State Legislatures maintainsa webpage on state cloning laws athttpwwwncslorgprogramshealthgeneticsrt-shclhtm

60 Denise Gellene ldquoStem Cell Firms Bet on Big PayoffrdquoLos Angeles Times (November 7 2004) athttpgenetics-and-societyorgnewsdispaspid=649Justin Hibbard ldquoDivvying Up The Stem Cell BonanzardquoBusiness Week (November 22 2004) athttpwwwbusinessweekcommagazinecontent04_47b3909054_mz011htm John M Broder ldquoCaliforniarsquosNew Stem-Cell Initiative Is Already Raising ConcernsrdquoNew York Times (November 27 2004) athttpwwwnytimescom20041127national27stemhtm

61 Megan Garvey ldquoStem Cell Spending Fight Buildsrdquo LosAngeles Times (December 7 2004) at httpgenetics-and-societyorgnewsdispaspid=671 Laura MecoyldquoControversy embroils stem cell panelrdquo Sacramento Bee(December 17 2004) at httpwwwgenetics-and-societyorgnewsdispaspid=681 Bernadette TanseyldquoProp 71rsquos fine print contains surprisesrdquo San FranciscoChronicle (December 8 2004) at httpsfgatecomcgi-binarticlecgifile=ca20041208MNGPBA8DPN1DTLTerri Somers ldquolsquoCoronationrsquo of committee head on stemcell funds disturbs somerdquo San Diego Union-Tribune(December 15 2004) at httpwwwsignonsandiegocomuniontrib20041215news_1n15kleinhtml

62 ldquoEditorial Stem cell panel must show accountability tothe publicrdquo San Jose Mercury News (January 11 2005)at httpwwwgenetics-and-societyorgnewsdispaspid=696 Carl T Hall ldquoBumpy start forstem cell programrdquo San Francisco Chronicle (January 42005) at httpsfgatecomcgi-binarticlecgif=ca20050104BAG1TAKKF41DTLamptype=science Lisa M Krieger and Paul Jacobs ldquoStem cellpanelists show holdings Economic reports leave someobservers uneasyrdquo San Jose Mercury News (January 192005) at httpwwwgenetics-and-societyorgnewsdispaspid=699

63 Dan Morain ldquoSchwarzenegger a Big Fundraiser in2004rdquo Los Angeles Times (February 1 2005) TerriSomers ldquo5 with Prop 71 campaign land jobs at newinstituterdquo San Diego Union-Tribune (February 4 2005)at httpwwwsignonsandiegocomuniontrib20050204news_1n4stemcellhtml Carl T Hall ldquoNewcriticism for stem cell programrdquo San Francisco Chronicle(February 18 2005) at httpwwwsfgatecomcgi-binarticlecgifile=chroniclearchive20050218BAG45BD1P418DTL

64 ldquoEditorial Cell breakrdquo Sacramento Bee (March 6 2005)at httpwwwgenetics-and-societyorgnewsdispaspid=723Idan Ivri ldquoCell Out Management issues plaguedistribution of $3 billion in state stem cell researchfundsrdquo Los Angeles City Beat (March 24 2005) at

httpwwwlacitybeatcomarticlephpid=1837ampIssueNum=94 Terri Somers ldquoStem cellinstitute leader in the hot seatrdquo San Diego Union-Tribune(March 10 2005) at httpwwwsignonsandiegocomnewsstate20050310-9999-1n10stemshtml ldquoSenatorsRunner and Ortiz Introduce Legislative Package toProtect Publicrsquos Investment In Stem Cell Researchrdquopress release (March 16 2005) athttprepublicansencagovnews17pressrelease3283asp

65 See Appendix 3 released April 6 2005 athttpwwwgenetics-and-societyorgpoliciescaliforniaconflictshtml Terri Somers ldquoStem cell panel facingallegations of conflictrdquo San Diego Union-Tribune (April7 2004) at httpwwwsignonsandiegocomnewsmetro20050407-9999-1n7stemhtml Tali WoodwardldquoCelling out The directors of stem cell institute havedirect ties to biotech firms that stand to gainrdquo SanFrancisco Bay Guardian (April 6 to 13 2005) athttpwwwsfbgcom3927news_stem_cellhtml LauraKurtzman ldquoStem-cell research clash Senate panel raisesbar on conflict-of-interest rulesrdquo San Jose Mercury News(April 21 2005) at httpwwwmercurynewscommldsiliconvalleybusinesscolumnistsgmsv11451837htm

66 Laura Mecoy ldquoStem cell headquarters headed to SanFranciscordquo Sacramento Bee (May 7 2005) athttpwwwsacbeecomcontentpoliticsstory12851821p-13701462chtml ldquoStem-cell oversight bill iscriticizedrdquo San Jose Mercury News (May 24 2005) athttpwwwgenetics-and-societyorgnewsdispaspid=776ldquoEditorial Stop fighting curbs on favoritismrdquo San JoseMercury News (May 5 2005) at httpwwwgenetics-and-societyorgnewsdispaspid=766 ldquoEditorial Stem CellResearch Accountabilityrdquo Los Angeles Times (May 262005) at httpwwwgenetics-and-societyorgnewsdispaspid=778 ldquoEditorial Rogue operatorrdquoSacramento Bee (May 22 2005) at httpwwwgenetics-and-societyorgnewsdispaspid=785 For the discussionof taxable bonds see the transcript and handout ldquoSCA13 (OrtizRunner) Analysisrdquo from the May 23 2005ICOC meeting at httpwwwcirmcagovtranscriptspdf200505-23-05pdf and httpwwwcirmcagovmeetingspdf20050523052305_item_8bpdf

67 Stuart Leavenworth ldquoNearly an internal coup againststem cell czarrdquo Sacramento Bee (June 23 2005) athttpwwwsacbeecomcontentopinionstory13112498p-13956952chtml Carl T Hall ldquoStatersquos stem cell boardopposes proposal for increased oversightrdquo San FranciscoChronicle (June 7 2005) at httpsfgatecomcgi-binarticlecgifile=ca20050607BAGUKD4JF71DTL

68 David P Hamilton ldquoCalifornia Stem-Cell Agency GetsOff to Inauspicious Startrdquo Wall Street Journal (July 52005) at httpwwwgenetics-and-societyorgnewsdispaspid=850 Terri Somers ldquoTaxpayers unlikelyto get quick stem cell windfallrdquo San Diego Union-Tribune(July 17 2005) at httpwwwsignonsandiegocomuniontrib20050717news_1n17stemshtml ldquoEditorialStem cell folliesrdquo Sacramento Bee (July 17 2005) athttpwwwgenetics-and-societyorgnewsdispaspid=814

32


69 Terri Somers ldquoReport finds stem cell windfallassumptions unrealisticrdquo San Diego Union-Tribune(August 25 2005) at httpwwwsignonsandiegocomuniontrib20050825news_1b25stemshtml ldquoEditorialStem cell funding is venture capitalrdquo San FranciscoExaminer (August 30 2005) at httpsfexaminercomarticles20050831opinion20050831_op01_editorialtxt

70 ldquoICOC Approves First Stem Cell Grants In CaliforniardquoCIRM press release (September 9 2005) athttpwwwcirmcagovpressreleases20050909-09-05_iiasp ldquoEditorial Stem cell oversight board isflying blindrdquo Sacramento Bee (September 18 2005) athttpwwwsacbeecomcontentopinionstory13578719p-14419234chtml Steve Johnson ldquoWho will benefitmore consumers or drug firmsrdquo San Jose Mercury News(September 29 2005) at httpwwwgenetics-and-societyorgnewsdispaspid=845 Malcolm MaclachlanldquoStem cellrsquos shell gamerdquo Capitol Weekly (September22nd 2005) at httpwwwcapitolweeklynetnewsarticlehtmlarticle_id=108

71 Bernadette Tansey ldquoTax law casts doubt on stem cellroyalties State may not reap billions promised to voterslast fallrdquo San Francisco Chronicle (October 25 2005) athttpwwwsfgatecomcgi-binarticlecgifile=ca20051025MNGTFFDK8J1DTL Carl T HallldquoStem cell institute considers where to startrdquo San Francisco Chronicle (October 2 2005) athttpwwwsfgatecomcgi-binarticlecgif=ca20051002BAGELF1E661DTL

72 Stuart Leavenworth ldquoStem cell royalty promise justelection ruserdquo Sacramento Bee (November 7 2005) athttpwwwsacbeecomcontentopinionstory13826776p-14667506chtml

73 Andrew Pollack ldquoCaliforniarsquos Stem Cell Program IsHobbled but Staying the Courserdquo New York Times(December 10 2005) at httpwwwnytimescom20051210business10stemhtml the draft IP policy is athttpwwwcirmcagovmeetingspdf20051212-06-05_item_9pdf with some changes evident fromthe transcript of the December 6 2005 ICOC meeting athttpwwwcirmcagovtranscriptspdf200512-06-05pdf

74 The Form 700s are online at httpwwwgenetics-and-societyorgpoliciescaliforniaconflictshtml

75 ldquoZymoGenetics Researchers Identify Novel Interleukinthat Plays Key Role in Immune System Regulationrdquo

press release (November 2 2000) athttpwwwzymogeneticscomirnewsItemphpid=250206

76 httpwwwrenoviscom and ldquoHuman embryonic stemcell research and human cloningrdquo athttpwwwastrazenecacomarticle511619aspx

77 See httpwwwrenoviscomabt_lead_bd_walkershtml

78 ldquoRPI Chiron City of Hope and Childrenrsquos HospitalAnnounce Initiation of Phase IIIa HIV Gene TherapyStudies lsquoStem Cellrsquo Gene Therapy for HIV The FirstRibozyme Administration to Human lsquoStem Cellsrsquordquo pressrelease (March 18 1997) athttpwwwaegiscomnewspr1997PR970318html

79 Lisa M Krieger and Paul Jacobs ldquoStem cell panelists showholdingsrdquo San Jose Mercury News (January 19 2005) athttpwwwgenetics-and-societyorgnewsdispaspid=699

80 Matthew Herper ldquoAmgen Profits From Stem Cell IPOrdquoForbescom (January 21 2005) at httpwwwforbescommarkets200501210121automarketscan09html andViaCellrsquos 2004 Form 10-K at httpgetfilingscomo0000950135-05-001790html

81 ldquoGenoptix Inc Raises $17 Million in Series B Financingrdquopress release (January 28 2002) athttpwwwatvcomincludescontentpress28jan02genphp3

82 ldquoBoston Scientific and Osiris Therapeutics AnnounceStem Cell Alliancerdquo press release (March 11 2003) athttpwwwbostonscientificcomcommon_templatesarticleDisplayTemplatejhtmltask=tskPressReleasejhtmlampsectionId=2amprelId=2425ampuniqueId=ABPR2202ampclickType=endecaampacceptedWarning=PR

83 Numerous references can be found via a web searchhttpwwwgenentechcomsearchq=22stem+cell22ampbtnG=Searchampoutput=xml_no_dtdampsort=date3AD3AL3Ad1ampie=UTF-8ampomniacct=genecomampclient=gene_frontendampoe=UTF-8ampproxystylesheet=gene_frontendampsite=www-gene-comamplastVisitedSite=ampfilter=0

84 Numerous references can be found via a web searchhttpsearchstratagenecomindex=19012amplastq=ampdoc0=0ampsortsel=relampopt=ANYampquery=22stem+cell22

85 Supra note 83 and ldquoMedtronic University of MinnesotaJoin to Accelerate Stem Cell Research in Quest forCardiovascular Therapiesrdquo press release (September 302002) at httpwwwpmedtroniccomNewsroomNewsReleaseDetailsdoitemId=1096494658984amplang=en_US

Acknowledgments Lead authors of this report are Jesse Reynolds director of CGSrsquos Project on Biotechnology Accountability and CGS

Associate Executive Director Marcy Darnovsky Invaluable assistance was provided by CGS Executive Director

Richard Hayes CGS Communications Director Parita Shah and CGS associate Pete Shanks Special thanks to Ralph

Brave Leif Wellington Haase Francine Coeytaux Charles Halpern David Winickoff Kathay Feng Susan Fogel and

Design Action CGS is solely responsible for the content of this report

CIRM Year One Progress Report

Introduction

Report format

The California Institute for


Ensuring returns on public i

Did CIRM leadership mislead


Recommendations

Establishing Accountable and

Minimizing conflicts of inte

Cooperating with the state l

Fostering transparency with

Providing responsible leader

Stem cell politics in the st

Recommendations

Establishing Ethical Safegua

Protecting women who provide

Preventing reproductive clon

Recommendations

Conclusion Key Issues in th

Appendix 1 Timeline

Appendix 2 The Independent

Appendix 3 Personal Conflic

Endnotes

Acknowledgments

endnotespdf


Introduction

Report format






Recommendations







Recommendations




Recommendations


Appendix 1 Timeline




A Progress ReportJanuary 2006

About the Center for Genetics and Society

The Center for Genetics and Society is a nonprofit public affairs organization working toencourage responsible uses and effective societal governance of the new human genetic andreproductive technologies

CGS works in a context of support for the equitable provision of health technologies domes-tically and internationally for womenrsquos health and reproductive rights for the protection ofour children for the rights of the disabled and for precaution in the use of technologies thatcould alter the fundamental processes of the natural world

CGS supports benign and beneficent medical applications of the new human genetic andreproductive technologies and opposes those applications that objectify and commodifyhuman life and threaten to divide human society

CGS supports embryonic stem cell research and public funding for it We believe that thisresearch should and can be conducted in a responsible manner with effective oversight andin the public interest

CGS is a project of the Tides Center

The Center for Genetics and Society

436 14th Street Suite 700

Oakland CA 94612

1-510-625-0819 tel

1-510-625-0874 fax

wwwgenetics-and-societyorg

infogenetics-and-societyorg

For more information or additional copies of this report

2




Introduction 5

Report format 6






Recommendations11








Recommendations16




Recommendations19





Endnotes 28

Acknowledgments 32

3






Prologue











4






5












Introduction








C-

6





Report format

















7









Notes



8














Keeping promises

C-


C

9








Notes






10















D








of Californiardquo


11






Recommendations





12

















C-

C

D












13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






New York Times

NOV60











JAN62

FEB63

MARCH64










Appendix 1 Timeline


2005





APR65

2004



22

23












JUNE67

JULY68

AUG69

SEPT70

OCT71

NOV72

DEC73



















24



























25









26


















27











28














12 Ibid


Endnotes

29




















30 Ibid





30




37 Supra note 1





















31















32


























Introduction

Report format






Recommendations







Recommendations




Recommendations


Appendix 1 Timeline



Endnotes

Acknowledgments

endnotespdf


Introduction

Report format






Recommendations







Recommendations




Recommendations


Appendix 1 Timeline



2




Introduction 5

Report format 6






Recommendations11








Recommendations16




Recommendations19





Endnotes 28

Acknowledgments 32

3






Prologue











4






5












Introduction








C-

6





Report format

















7









Notes



8














Keeping promises

C-


C

9








Notes






10















D








of Californiardquo


11






Recommendations





12

















C-

C

D












13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






New York Times

NOV60











JAN62

FEB63

MARCH64










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12 Ibid


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30 Ibid





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37 Supra note 1





















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3






Prologue











4






5












Introduction








C-

6





Report format

















7









Notes



8














Keeping promises

C-


C

9








Notes






10















D








of Californiardquo


11






Recommendations





12

















C-

C

D












13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






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2004



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25









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12 Ibid


Endnotes

29




















30 Ibid





30




37 Supra note 1





















31















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4






5












Introduction








C-

6





Report format

















7









Notes



8














Keeping promises

C-


C

9








Notes






10















D








of Californiardquo


11






Recommendations





12

















C-

C

D












13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






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2004



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25









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12 Ibid


Endnotes

29




















30 Ibid





30




37 Supra note 1





















31















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5












Introduction








C-

6





Report format

















7









Notes



8














Keeping promises

C-


C

9








Notes






10















D








of Californiardquo


11






Recommendations





12

















C-

C

D












13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






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2004



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25









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12 Ibid


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29




















30 Ibid





30




37 Supra note 1





















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6





Report format

















7









Notes



8














Keeping promises

C-


C

9








Notes






10















D








of Californiardquo


11






Recommendations





12

















C-

C

D












13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






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25









26


















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12 Ibid


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30 Ibid





30




37 Supra note 1





















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Appendix 1 Timeline




7









Notes



8














Keeping promises

C-


C

9








Notes






10















D








of Californiardquo


11






Recommendations





12

















C-

C

D












13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






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JAN62

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2005





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2004



22

23












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25









26


















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12 Ibid


Endnotes

29




















30 Ibid





30




37 Supra note 1





















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8














Keeping promises

C-


C

9








Notes






10















D








of Californiardquo


11






Recommendations





12

















C-

C

D












13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






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2005





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2004



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23












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25









26


















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12 Ibid


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29




















30 Ibid





30




37 Supra note 1





















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9








Notes






10















D








of Californiardquo


11






Recommendations





12

















C-

C

D












13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






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JAN62

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2005





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2004



22

23












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25









26


















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28














12 Ibid


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29




















30 Ibid





30




37 Supra note 1





















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10















D








of Californiardquo


11






Recommendations





12

















C-

C

D












13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






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2005





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2004



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25









26


















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28














12 Ibid


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29




















30 Ibid





30




37 Supra note 1





















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11






Recommendations





12

















C-

C

D












13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






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2004



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25









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12 Ibid


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30 Ibid





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37 Supra note 1





















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12

















C-

C

D












13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






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2004



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25









26


















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37 Supra note 1





















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13














D













14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






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2005





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2004



22

23












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25









26


















27











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12 Ibid


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30 Ibid





30




37 Supra note 1





















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14









Constitutionrdquo


B















15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


Recommendations










20





















21






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2005





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2004



22

23












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25









26


















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12 Ibid


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29




















30 Ibid





30




37 Supra note 1





















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15





Notes




D


16


Recommendations














17














C+C+










18
















C

19


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20





















21






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2005





APR65

2004



22

23












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25









26


















27











28














12 Ibid


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30 Ibid





30




37 Supra note 1





















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16


Recommendations














17














C+C+










18
















C

19


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20





















21






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2005





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2004



22

23












JUNE67

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25









26


















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12 Ibid


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37 Supra note 1





















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17














C+C+










18
















C

19


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20





















21






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2005





APR65

2004



22

23












JUNE67

JULY68

AUG69

SEPT70

OCT71

NOV72

DEC73



















24



























25









26


















27











28














12 Ibid


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29




















30 Ibid





30




37 Supra note 1





















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18
















C

19


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20





















21






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2005





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2004



22

23












JUNE67

JULY68

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SEPT70

OCT71

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DEC73



















24



























25









26


















27











28














12 Ibid


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29




















30 Ibid





30




37 Supra note 1





















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Appendix 1 Timeline



19


Recommendations










20





















21






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2005





APR65

2004



22

23












JUNE67

JULY68

AUG69

SEPT70

OCT71

NOV72

DEC73



















24



























25









26


















27











28














12 Ibid


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29




















30 Ibid





30




37 Supra note 1





















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20





















21






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2005





APR65

2004



22

23












JUNE67

JULY68

AUG69

SEPT70

OCT71

NOV72

DEC73



















24



























25









26


















27











28














12 Ibid


Endnotes

29




















30 Ibid





30




37 Supra note 1





















31















32


























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21






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2004



22

23












JUNE67

JULY68

AUG69

SEPT70

OCT71

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24



























25









26


















27











28














12 Ibid


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29




















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30




37 Supra note 1





















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2004



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23












JUNE67

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OCT71

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24



























25









26


















27











28














12 Ibid


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29




















30 Ibid





30




37 Supra note 1





















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23












JUNE67

JULY68

AUG69

SEPT70

OCT71

NOV72

DEC73



















24



























25









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28














12 Ibid


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29




















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37 Supra note 1





















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24



























25









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12 Ibid


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30 Ibid





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37 Supra note 1





















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25









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12 Ibid


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37 Supra note 1





















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26


















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12 Ibid


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27











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12 Ibid


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29




















30 Ibid





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37 Supra note 1





















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28














12 Ibid


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29




















30 Ibid





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37 Supra note 1





















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29




















30 Ibid





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37 Supra note 1





















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Appendix 1 Timeline



the california stem cell program at one year...proposition 71, a land-mark initiative author-izing...

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