Trump, Fetal Tissue Restrictions and California's Stem Cell Agency

The $5.5 billion ballot proposal to save California's stem cell agency from financial extinction popped up this week in a discussion of the Trump administration's looming restrictions on the use of fetal tissue.  

The proposed ballot initiative surfaced in a lengthy piece in "The Scientist" magazine, which said, 

"The Trump administration’s changes to policy involving material donated from abortions have led scientists to adjust their research projects or seek alternative sources of funding."

The author of the article, Diana Kwon, interviewed researchers around the country, who spoke of how they were dealing with the new reality. One of them was Andrew McMahon of the University of Southern California, who was recruited to the Golden State with the help of a $5.5 million award from the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is known. 

Kwon said that McMahon "still has about a year left before he needs to apply for more funding, and he’s started looking into potential alternatives to NIH." 

She noted that the NIH restrictions are yet to be fleshed out and continued with comments from McMahon,

"'My understanding is that it’s not entirely clear at the moment what that process is going to be,' McMahon says. 'I’ve been using the time to obtain non-NIH funding to support aspects of the research that I would have tried to get NIH funding [for] in the future.'"

Also quoted was Larry Goldstein, director of the UC San Diego stem cell program. Kwon wrote, 

"In California, the state’s stem cell agency, the California Institute for Regenerative Medicine (CIRM) has provided funding for stem cell studies using fetal tissue since it was founded in 2004. That fund is about to run out, but (a proposed ballot initiative) that would provide $5.5 billion in funding to CIRM (is expected to) come before voters in November.

"'That will hopefully provide funding for areas of fetal tissue research that involves stem cells,' Goldstein says. 'But . . . it’s ridiculous to rely on one or two states to self-fund, because we don’t have all of the best and brightest [scientists], and it means lots of students and postdocs will train in areas where federal training support will be unavailable to them.'"

Trump Research Restrictions, the California Stem Cell Agency and Moral Obligations

The man expected to lead the drive for $5.5 billion more for California's stem cell agency today said the Trump restrictions on fetal tissue research represent a dangerous precedent that threatens the health of all Americans. 

Robert Klein, who was the first chairman of the state stem cell agency, said that "California has unique opportunity and obligation to maintain the scientific and medical options" that have led to development of the polio vaccine along with many others.

During an interview with the California Stem Cell Report, Klein said the people of California have a "moral" obligation to add more billions to the work of the 14-year-old, $3 billion stem cell agency.

Klein led the 2004 ballot initiative campaign that created the agency, formally known as the California Institute for Regenerative Medicine (CIRM).  The agency expects to run out of cash for new awards by the end of this year. It is staking its existence on a proposed ballot initiative that Klein would carry forward.

Klein's comments came as more reaction surfaced to the Trump action. San Francisco HIV advocate Jeff Sheehy, responding to a question, said in an email,

"Fetal tissue is used to make mice with human immune systems.  Testing new drugs for HIV is just one use--this animal model is used in research across a wide range of diseases to develop and test therapies, including vaccines for infectious diseases.  Stopping this research--which has been taking place for decades--is foolish, anti-science, and a threat to the health and safety of all Americans."

Kaiser Health News reported,

"The Trump administration’s announcement Wednesday about federal cutbacks in fetal tissue research is short of a total ban, but scientists in the field say it is concerning because it could affect work on treatments or preventions for key diseases, such as HIV and Parkinson’s."

Sara Reardon, reporting online for Nature, wrote,

"'It’s a decision that’s going to set back research,' says Andrew McMahon, a stem cell biologist at the University of Southern California in Los Angeles. 

"McMahon is studying ways to grow kidneys from human stem cells. He says that the only way to determine whether he and his colleagues have successfully mimicked natural development is to compare their proto-organs to kidneys in fetal tissue. Although biomedical research is often done using mice as proxies for people, mouse kidneys are too different from human kidneys to use in McMahon’s work."

McMahon was the recipient of a $5.7 million CIRM award dealing with kidney problems. A CIRM document filed in connection with his now concluded research said,

"Our analysis of the developing human kidney has provided the first comprehensive insight into developmental processes highlighting molecular and cellular events shared with the well-studied mouse model, but unique human features."

McMahon was recruited from Harvard to USC with the help of the CIRM grant. In response to an email query, he said that it was unclear whether his CIRM research would have become ineligible for federal support, given new Trump review processes. 

Bradley Fikes and Gary Robbins of the San Diego Union-Tribune wrote, 

"The sensitivity of the (fetal tissue research) matter surfaced recently when UCSD drew unwanted attention after one of its employees mistakenly solicited fetal pancreas samples from the Center for Medical Progress (CMP), an anti-abortion group whose surreptitious videos in 2015 galvanized efforts to end federal funding of Planned Parenthood."

Trump Action on Fetal Tissue Research: Likely Impact on $5 Billion More for California Stem Cell Agency

President Trump today sharply cut back on federal funding for fetal tissue research in a move denounced as both politically motivated and destructive of the hopes of millions of Americans suffering from life-threatening diseases. 

The action has long been sought by anti-abortion activists who say tax dollars should not go to create a "marketplace for aborted baby parts."

Trump's moves immediately cost UC San Francisco a $2 million grant aimed at new therapies for HIV. It also drew reaction from California's $3 billion stem cell agency. 

Asked for a comment, Kevin McCormack, senior director of communications, said the Trump action will not have any impact on the agency. He said in an email, 

"Because our money comes from California this does not affect any project we fund or our ability to fund any projects."

Trump's action echoes a situation that played a major role in the ballot initiative campaign of 2004 that created the stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM). 

In one of their key arguments, backers of the stem cell measure said it was needed because of then President Bush's restrictions on federal funding for human embryonic stem cell research.

Today's action by Trump is virtually certain to be cited as justification for an additional $5 billion for the agency, which will run out of money for new awards around the end of this year. CIRM supporters expect to mount another ballot initiative in November 2020.

The scope of Trump's move was described by the New York Times, which wrote, 

"As of last year, the N.I.H. spent about $100 million of its $37 billion annual budget on research projects involving fetal tissue. The tissue is used to test drugs, develop vaccines and study cancer, AIDS, Parkinson’s disease, birth defects, blindness and other disorders. For much of that work, scientists say there is no substitute for fetal tissue."

Sam Hawgood, chancellor of UC San Francisco and a former member of CIRM's governing board, said in a statement that the decision was "politically motivated, shortsighted and not based on sound science.”

Lawrence O. Gostin, a professor specializing in public health law at Georgetown University, told the New York Times that the federal action "is akin to a ban on hope for millions of Americans suffering from life-threatening and debilitating diseases." 

Scientist Jeanne Loring, who is with Scripps Research and Aspen Neuroscience in the San Diego area, said in response to a query, 

"Fetal brain tissue transplants containing immature dopamine neurons laid the groundwork for the Parkinson’s disease neuron replacement therapy we are developing now  The outcomes were inconsistent, but some patients recovered from the disease.  Without that pioneering work in the 1990s, I wouldn’t be so confident about the potential of our planned therapy using dopamine neurons derived from Parkinson’s patients’ own induced pluripotent stem cells.

"This is one specific instance of how fetal tissue profoundly changed our view of degenerative disease.  I think that going forward, most of the regenerative therapies will be based on pluripotent stem cells, which weren’t available 30 years ago. But I don’t like to rule out the possibility that there is still pioneering work like this to be done, and so I hope that some researchers will not lose access to fetal tissue for groundbreaking medical research."

(Editor's note: Look for additional news tomorrow on the impact of the Trump decision in California and elsewhere on the California Stem Cell Report.)

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.

The StemExpress Controversy and Collateral Damage

Back in July, after the Planned Parenthood, anti-abortion controversy erupted and entangled a California firm, one Internet headline read,

“Fetus Miner’s Friends in High Places”

The site that posted the headline was the American Conservative. The item referred to Charlotte Ivanic, the older sister of Cate Dyer, CEO of StemExpress LLC of Placerville. It is the stem cell and human tissue firm that was named in the videos involving Planned Parenthood.

In July, Ivanic was the highly regarded top health policy aide to House Speaker John Boehner, who denounced Planned Parenthood and approved House committee investigations into Planned Parenthood and StemExpress.

Dyer once said that her sister is “one of her biggest inspirations.”

Now she is gone from public service. She left on Aug. 5 and has become a Capitol Hill lobbyist. In a press release, Boehner said, 

“Charlotte has spearheaded some of our most significant accomplishments on behalf of the American people. She is one of the best I’ve seen at bringing people together to find common ground, and she leaves Boehnerland with the deepest respect — and best wishes — of her peers as well as lawmakers from both parties.” 

The news about her resignation was slow to ripple out. It was only yesterday that one anti-abortion Web site caught up with the news. Fireandreamitchell.com had this to say, 

“It took three weeks for Charlotte Ivancic to resign from John Boehner’s staff after the videos went public. This yet again shows that John Boehner is just a progressive like liberal Democrats. Why else would he have a leftist like Charlotte Ivancic on his staff in the first place? John Boehner is not only mentally unstable but a progressive hack too. Boehner has to go, NOW!”

StemExpress: Anti-Abortion Activists Telling "Long Series of Lies"

A beleaguered California company caught in the national, anti-abortion controversy involving Planned Parenthood late today said its foes were engaged in a “long series of lies.”

The company, StemExpress LLC of Placerville, made the charge in a statement that included the unedited portions of the latest anti-abortion video along with a transcript of what was said.
(If you would like the video, please email djensen@californiastemcellreport.com. It is a large file.)

The firm said,

“David Daleiden and the Center for Medical Progress today released their latest heavily edited, highly-deceptive video in which they claim StemExpress “admitted” to receiving fully intact fetuses from Planned Parenthood….

“During the video, the parties refer to 'cases,' which is a term of art referring to livers in this conversation. CMP’s accusations that this conversation somehow refers to 'intact fetuses,' which were never mentioned at any point during the entirety of the illegally recorded conversation, are false.

“StemExpress has never requested, received or provided to a researcher an “intact fetus.” CMP’s and Daleiden’s claims to the contrary are unequivocally false.”

The statement and release of the transcript reflected a more aggressive posture on the part of StemExpress, which has lost business as a result of the activists’ efforts. Its employees have also been threatened with violence.

Here is the full text of the StemExpress statement.

“StemExpress today released the following concerning CMP’s 8th video:

“David Daleiden and the Center for Medical Progress today released their latest heavily edited, highly-deceptive video in which they claim StemExpress ‘admitted’ to receiving fully intact fetuses from Planned Parenthood. Accompanying this document is a link to the unedited part of that video where this supposed admission discussion occurred, as well as a transcript of what was actually said.

“As anyone can see and read, the entire discussion was in fact about ‘intact livers.’ Livers are among the most urgently needed of medical tissues by scientists and medical researchers working to cure cancer, diabetes and Alzheimer’s disease.

“During the video, the parties refer to ‘cases,’ which is a term of art referring to livers in this conversation. CMP’s accusations that this conversation somehow refers to ‘intact fetuses,’ which were never mentioned at any point during the entirety of the illegally recorded conversation, are false.

“StemExpress has never requested, received or provided to a researcher an ‘intact fetus.’ CMP’s and Daleiden’s claims to the contrary are unequivocally false.

“Earlier today, a court found that this footage was likely obtained in violation of California criminal law prohibiting the illegal recording of private conversations. In a different court later this afternoon, Daleiden and his CMP co-defendants invoked the 5th Amendment rather than answer questions about their ongoing illegal activities in a related case in federal court. The release of today’s video and CMP’s claims about it are just another in a long series of lies.”

California's StemExpress Loses Bid to Block Anti-Abortion Videos; Appeal Being Considered

A Los Angeles judge today rejected a bid by a California stem cell/human tissue firm to halt the release of an anti-abortion video that the firm said is harming its business and endangering the lives of its employee.

The firm, StemExpress LLC of Placerville, said, however, it is considering appealing the ruling.

Brian Melley of The Associated Press wrote,

“Los Angeles Superior Court Judge Joanne O'Donnell rejected efforts by StemExpress to block the videos, though she said the company likely will prevail in its lawsuit claiming its privacy was violated by an anti-abortion activist posing as a biomedical company employee.”

Melley continued,

“StemExpress won a temporary restraining order last month, but O'Donnell said Friday that the center's First Amendment rights to release the videos trumped the company's right to block them under their privacy claims.

“The judge said she couldn't tell who was telling the truth about how confidential the May meeting was, but she said the fact (David) Daleiden concealed his identity and secretly recorded the conversation made his account less believable.

“O'Donnell rejected the center's argument that the secret recordings were legal under an exemption that allows such subterfuge if someone believes they are gathering evidence of a crime.

"'Defendants' apparent ideological conviction that fetal tissue procurement is a violent felony does not, without more (evidence), rise to the level of a 'reasonable belief,' O'Donnell wrote.”

California Firm Says Anti-abortion Activists Misleading Courts, Endangering its Employees

A California stemcell/human tissue company this morning renewed its efforts to halt distribution of a video by anti-abortion activists that it says will endanger its employees and damage its business.

The firm, StemExpress LLC of Placerville, said in court filings that it was only seeking to stop the distribution of the video, not the information contained within it.

It said that the activists, the Center for Medical Progress of Irvine, Ca.,  and David Daleiden, have misled the judge in the case. The firm said the activists want to distribute the video to “inflame” the public against the company and provoke a “hostile reaction.” The company has already received death threats against its president.

StemExpress also said its request for a preliminary injunction does not violate the First Amendment of the Constitution.

The firm argued that such orders have been upheld in other cases “where anti-abortion protesters were constitutionally enjoined not in what they wanted to say, but how, where, and when they wanted to say it.  Such injunctions are simply not subject to strict constitutional scrutiny.”

The activists have argued that they did not violate state law barring recording the conversations without the permission of all parties because the discussions involved a crime -- “harvesting and killing live babies for resale.”

StemExpress noted that the activists did not report any alleged crimes to authorities during a two-year investigation.

The court filing said the activists’ belief that StemExpress is

“…‘harvesting and killing live babies for resale’ is neither objectively reasonable nor credible from a subjective standpoint.  First, abortion before viability is not murder in California…. While defendants may wish that abortions were illegal and constitute murder, that is simply not the law.  This alone precludes defendants’ purported ‘defense’ of their illegal conduct.  Second, defendants have no evidence that would even remotely support the claim that plaintiffs participated in any abortion procedure involving a viable fetus.  To state the obvious, StemExpress does not perform abortions.  And contrary to Daleiden’s hearsay statements, StemExpress has never received a living, fully-intact fetus from an abortion clinic.”

Here is the full text of this morning's filing.

  StemExpress filing 8-21-15 for preliminary injunction