14 December 2020

The recent close-call US presidentialelection grabbed headlines, but no less closely-fought was California's Proposition 14, also on the ballot in October, which will have a huge impact on the future of stem cell research in the state.

The Stem Cell Research Institute Bond Initiative (Prop 14),whichwas on theballotinthe initiated state statutewill allow the state to issue billions of dollars in bonds for its stem cellresearch programme. The vote could not have been closer, with 51 percent of ballots for and 49 percent against.

This initiative will enable financiers to lend US $5.5 billion to a stem cell agency, the California Institute for Regenerative Medicine (CIRM) whichthe state's taxpayers will repay with interest over the next three decades. The sizeable bond fund will be allocated to research, human clinical trials and programmes and also for start-up costs for facilities in the stem cell field. About US $1.5 billion of the money will be spent researching neurodegenerative conditions, including Alzheimer's, Parkinson's and dementia. Some of the funds will be allocated to the shared labs programme:state-funded facilities dedicated to conducting studies on human embryonic stem cells. A working groupfocused on improving access to medical treatments will be established, as well astraining and fellowship programmes for undergraduate and postgraduate students.

Stem cell research is in its infancy, with some treatments that have worked in animals now progressing to humantrials. The research is promising, as the ability to generate specialised cells could eventually be used torepair or replace damaged tissues and organs. However, there are ethical controversies surrounding stem cell research, especially regarding embryonic stem cells derived from early human embryos.

In 2001, the conservative Bush administration prohibited federal funding for stem cell research owing to the ethical concerns. This promptedreal estate developer and investor Robert Kleinto initiate the original Proposition 71 which aimed to establish a state constitutional right to conduct stem cell research in California in 2004.It was believed that Prop 71 would propel California as a world leader in stem cell research and 59 percent of Californians voted in favour.

The proposition also established CIRM the only state-funded stem cell research agency in the USA in the California Constitution. Since its inception, it has granted research funds to various institutions and companies including Stanford University and the University of California. So far, it has funded 68 clinical trials (phases 1-3) for a wide range of diseases and conditions, includingcancer, diabetes and many rare disorders.

In 2019, CIRMstarted to run out of funds, and by2020 hadsuspended applications for new projects except US $5 million in emergency funding for COVID-19 research. The Californians for Stem Cell Research, Treatments and Cures political action committee (PAC) responded with a campaign to boost funding via Prop 14. SupportersincludedUS House speaker Nancy Pelosi, California governorGavinNewsom, LA mayor EricGarcetti, the California Democratic Party and several organisations such as ALS Association and the Michael J Fox Foundation for Parkinson's research and Huntington's Disease Society of America.

There is also resistance to Prop 14:dissenters feel thattheinitiative has notdelivered its promises after 16 years. Furthermore the original rationale no longer applies asfederal funding is no longer blocked. Former President Barack Obama then removed the restrictions on embryonic stem cell research (a position unchanged by the Trump administration) which means California scientists can apply for (highly competitive) federal research grants.

In the current climate, Prop 14 will exacerbate California's already colossal budget deficits. The coronavirus pandemic has worsened housing crisesand unemployment rates, highly visible in cities like San Francisco and Los Angeles.

As Marcy Darnovsky, executive director of the Center for Genetics and Society, said:'It does nothing to address CIRM's built-in conflicts of interest, or its lack of legislative oversight despite it being an agency supported wholly by public funds. The new proposition makes some things worse; for example, it outsources critically important decisions about ethical standards to an unaccountable national committee... In the meantime, that campaign's shameless over-promising and hype set the stage for the hundreds of under-regulated commercial stem cell clinics now offering unapproved 'treatments' that have caused tumours and blindness...'

It is not surprising that Californians were so torn. Perhaps it's wiser to allocate the pot to more pressing matters like job creation, housing and other urgent needs?

Link:
California's Proposition 14: short in the arm for stem cell research - BioNews