Making 'Stem Cell Lemonade' in California

Trump visiting lab in China in 2017, whose research output is
surpassing the U.S. Photo: Andy Wong/AFP/Getty Images

California's $3 billion stem cell agency has what some might call an "unconscious" ally in its search for more billions to fuel its drive to create stem cell therapies and cures.

It is no small matter. The agency expects to run out of cash for new awards by the end of this year. It is hoping that voters will approve, in November of 2020, another $5 billion to carry on with its 14-year-old program, which is a pretty big ask.

Now comes President Trump with his latest proposed budget, which whacks away at scientific research. He is seeking to slash as much as $6 billion from the National Institutes of Health, the chief source of research funding in the country.

The American Association of Immunologists said this week that Trump's cuts “would devastate important research intended to prevent, treat, and cure innumerable diseases."

Trump's cuts play into a narrative that worked successfully in 2004 when California voters created the stem cell agency with 59 percent of them voting for Proposition 71. The campaign pushed the ballot initiative with the argument that then President Bush was crippling stem cell research and thus preventing development of new, nearly miraculous therapies.

Like Bush, Trump is something of a scientific villain, so to speak, one that can be used as a foil to convince the people of California to provide more money for stem cell research. Never let good villain go to waste might be the marching orders for the 2020 ballot campaign.

If not for California and its stem cell agency, voters would be told, children would have died (see here and here) and more than 50 clinical trials for stem cell treatments would have not existed.

It is no matter that Congress may not go along with Trump's reductions. The threat, which is likely to continue as long as Trump is president, is sufficient to fuel a ballot campaign.

Obviously, cuts in federal research funding are not something the scientific and biotech community applauds. Nonetheless, they could be picked apart to find morsels to feed a ballot campaign. The agency's backers might even say, "When the president gives you stem cell lemons, make stem cell lemonade."

California Stem Cell Opposition: Conservative Writer Declares Golden State Efforts a 'Bust'

In a preview of what is likely to be a heated ballot campaign next year,  a conservative writer declared this week that California's efforts to develop stem cell therapies are "a scientific and financial bust." 

"Back in 2004, the $3 billion California Stem Cell Research and Cures Initiative, Proposition 71, promised life-saving cures and therapies for Alzheimer’s, Parkinson’s and other diseases. The cures and therapies, in turn, would send money flowing into state coffers, so the project, in effect, would pay for itself. It didn’t exactly work out that way," said Lloyd Billingsley on two different web sites.  

"CIRM proved itself a scientific and financial bust, and almost completely off limits to state oversight."

Billingsley has written in the past about the agency, known as CIRM and formally as the California Institute for Regenerative Medicine. His latest columns appeared on the California Globe, which was founded by Ken Kurson, who has ties to the Trump family and Rudy Guiliani, and The Beacon.  

Billingsley likened the agency to the troubled bullet train project in California and efforts to solve some of California's water problems by building a tunnel under the California delta east of San Francisco. 

CIRM expects to run out of cash this year for new awards and hopes to survive with voter approval of a proposed, $5 billion bond measure on the November 2020 ballot.

It could be a hard-fought campaign, but conservatives and other likely opponents could well be diverted if President Trump is on the ballot. 

See here and here for more on Kurson, founder of the  California Globe, and here for the advisors to the Beacon web site and its parent organization.

Trump, Fetal Tissue and the California Stem Cell Agency

The California stem cell agency says the Trump Administration moves against research involving fetal tissue have had no impact on the projects that it is financing, at least so far.

The agency, formally known as the California Institute for Regenerative Medicine (CIRM), was responding to a question originally raised by a reader of the California Stem Cell Report.

The inquiry was triggered by a number of reports over the last few months concerning the federal direction away from fetal tissue, a move that one researcher, Warner Greene of the Gladstone Institutes in California, called "scientific censorship of the worst kind."

The California Stem Cell Report queried CIRM yesterday about the federal actions, asking whether they have had "any impact, direct or indirect, on CIRM awards, existing or likely in the future."

Kevin McCormack, senior director for CIRM communications, replied, noting that the federal move is relatively recent.

"It could mean an increase in applications that use fetal tissue but it’s too soon to tell. Regardless, this is why the people of California created CIRM, so we don’t have to worry about federal funding for potentially life-saving research. Because we are independent, we can fund what we think is the best science."

McCormack alluded to the ballot initiative in 2004 that established the agency. The campaign was largely based on the need to bypass the Bush administration's restrictions on stem cell research. The anti-fetal tissue effort is likely to be the first step towards resurrecting similar restrictions on stem cell research. 

Politically and ironically speaking, new federal restrictions on human embryonic stem cell research could build support for continued funding of CIRM, which is hoping for passage of a proposed $5 billion bond measure on the November 2020 ballot.

While fresh restrictions are not good for the field overall, their imposition could help to preserve the stem cell agency. Any ballot campaign needs a nasty villain to campaign against.

And without Bush to campaign against in 2004, the stem cell agency probably would never have come into existence.

Here are links to a few of the recent stories on the Trump fetal tissue move: Washington Post, Science, STAT.

Trump's 'Ouija' Stem Cell Policy Is Making Scientists Anxious

One of the bulwarks of the mainstream media today weighed in with a hefty assessment of Trump and stem cells, declaring that researchers are "anxious" about what is likely ahead.

Prominently mentioned by ABC News was Vice President-elect Mike Pence, who supported legislation in Indiana banning donation of fetal tissue for research. That law, signed by Pence as governor of Indiana, was temporarily halted by a judge, who questioned its constitutionality.

Alta Charo, a bioethicist and law professor at the University of Wisconsin, was quoted as saying that trying to determine what Trump's stem cell policy might be is a "little bit like using a Ouija board." But she did point to Pence's fetal tissue position.  Additionally, Trump has taken a pro life position on abortion.

Also cited in the article at some length was a spokesman for the $3 billion California stem cell agency, which owes its existence to presidential restrictions on human embryonic stem cell research. ABC reporter Gillian Mahoney wrote,

 "Kevin McCormack, communications director at California Institute for Regenerative Medicine, said reintroducing a funding ban to stymie research would likely be more difficult than it was in the early 2000s when stem cell research was a new field.

"'It would be like putting a genie back in the bottle,' said McCormack.

"Pointing to one case at the University of Southern California, where a paralyzed man regained hand movement after an experimental stem cell therapy, McCormack said any measures that would halt funding or restrict stem cell research wholesale, 'would be like going up to someone and say you can't have that treatment.'

"McCormack did note that more states have provided stem cell funding, including California, which provides grants for the California Institute for Regenerative Medicine. While state funding could help, the NIH provides a huge amount of funding for U.S. medical research, spending approximately $32 billion on medical research annually."

(Editor's note: The state does not provide grants for the stem cell agency. The agency uses state bonds to provide grants to researchers.  The agency's funding flows straight to it without intervention by lawmakers or the governor.)

Trump on Science and Biotech: Wild Card, Chilling or NIH Slasher?

Reaction today from the world of science, stem cells and biotech to the election of Donald Trump as president ranged from "party time" to "chilling" impact.

Here is a sampling of articles today that dealt with the implications of the billionaire's victory.

Dylan Scott wrote in Stat:

"Should President Donald Trump make drug makers relieved? Or anxious? They’re not sure."

Stat also carried a related piece by Damian Garde who said that Trump is a wild card who could side with those who want to cut back on federal funding of research.

An article in Science by Jeffrey Mervis quoted Robert Cook Deegan, a research scientist at Arizona State University, as saying,

"Science won't get much attention, except when it gets in the way or bolsters support for a political priority."

Adam Feuerstein wrote in The Street:

"Half the country woke up Wednesday depressed about President-elect Donald Trump. That group doesn't include investors in biotech and drugs stocks. They are partying like a giant drug-pricing cloud has been lifted from their shoulders."

An article in Nature by Jeff Tollefson, Lauren Morello and Sara Reardon had this:

"'I think at the very least it would put a chilling effect on the interest of scientists from other countries in coming here,' says Kevin Wilson, director of public policy and media relations at the American Society for Cell Biology in Bethesda, Maryland. Some researchers are already thinking about leaving the United States in the wake of the election."

An overview piece by Sarah Kaplan in the Washington Post had this line:

"Last year, Trump told conservative radio host Michael Savage, 'I hear so much about the NIH, and it’s terrible.'"

Yours truly wrote earlier today that Trump's victory could translate to good news for California's $3 billion stem cell agency. (That piece can also be found on Capitol Weekly.)

Trump: Helpmate to the $3 Billion California Stem Cell Agency?

Donald Trump's victory last night, oddly enough, could be good news for the future of the California stem cell agency. 

It could be George Bush all over again.

How does that work, you may ask? Trump is a bit of a blank slate on stem cell issues. He has not addressed them directly. But he is pro-life, a fact being celebrated this morning in the usual pro-life venues.

Given that stance, he is likely to reverse the federal government's current funding of human embryonic stem cell research. It would be easy to do, basically nothing more repealing an executive order or issuing a new one.

Such a move would echo the Bush restrictions on human embryonic stem cell research that provided the justification for the 2004 ballot initiative that created California's $3 billion stem cell research effort. Bush's opposition energized the scientific and patient communities on behalf of the initiative.

His opposition also helped to raise the $34 million for the electoral campaign that spawned the California Institute for Regenerative Medicine (CIRM), the official name of the stem cell agency.

Bush provided a big target for supporters of stem cell research. (See here and here.) He embodied the essence of the "anti-science" crowd. And in politics it is good to have a "demon" that can easily be understood. It simplifies issues, sharpens the focus and stimulates voters.

The stem cell agency is now on track to run out of money in 2020 for new awards. CIRM relies on state bonds for its cash but its ability to issue them is coming to an end. No additional source of funding has been identified.

Assuming Trump bans federal research on human embryonic stem cell research, it would bring new life to the possibility of another multi-billion dollar bond issue in the next few years. A new "demon" would surface. All the agency needs to do now is to come up with a high-impact therapy that would resonate with California voters.