The California Stem Cell Agency Speaks Out on Raelians and New Types of Human Beings

The California stem cell agency this morning is asking us all whether we remember the Raelians?

The agency, however, is not offering a $64,000 prize for the answer. No quiz show contest at the Oakland headquarters of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known.

Instead the Raelian recollection is the lead-in to a cautionary note about the reports out of China that a researcher, who once worked at Stanford, has genetically altered two babies in embryo. The news has triggered an international flap about the ethics involved along with warnings about gene editing that results in "new kinds of human beings."

Writing on the agency's blog, Kevin McCormack, senior director for CIRM communications, said,

"Remember the Raelians? Probably not. But way back in 2002 the group, some described them as a cult, claimed it had created the world’s first cloned baby. The news made headlines all around the world raising fears we were stepping into uncharted scientific territory. Several weeks later the scientist brought in by the Raelians to verify their claims called it an 'elaborate hoax.'"

McCormack cautioned that ultimately the news out of China could amount to the same sort of thing. 

He noted the use of the CRISPR gene editing technique which has made it much easier to dip into the genetic process. McCormack wrote,

"CRISPR has been making headlines all of its own in the last few years as a fast, cheap and efficient way of editing genes. CIRM supports research using CRISPR for problems such as sickle cell disease. The difference being that our research works with adults so any changes in their genes are just for them. Those changes are not passed on to future generations.

"The work making headlines around the world used CRISPR on embryos, meaning a child born from one of those embryos would pass those changes on to future generations. In effect, creating a new kind of human being."

McCormack picked up a sample of reaction around the world, including a comment from Stanford bioethicist Hank Greely on CNBC. Greeley said that that if the report is accurate, the research is "criminally reckless, and I unequivocally condemn the experiment.”

McCormack concluded,

"Our best hope right now is that this is just a repeat of the Raelians. Our worst fear, is that it’s not."

Genetically Altered Babies: A Bit of a California Connection

This You Tube video produced by He Jiankui had drawn 19,723 views at the time of this posting along with nearly 300 comments, pro and con.  The number of views jumped about 5,000 during one hour this morning.

The startling news about what is being described as the world's first gene-edited baby has a something of a California tie.

The scientist behind the work, He Jiankui, worked from 2010 to 2012 in the lab of Stephen Quake at Stanford University, who is participating in a $40 million genomics program backed by California's $3 billion stem cell agency.  

Like many other scientists, He Jiankui was trained in the United States, receiving his Ph.D. from Rice University. 

A statement on the web site of Direct Genomics, a company He Jiankui founded, said,

"He was working on genome sequencing research during his postdoc training in the lab of Stephen Quake at Department of Bioengineering, Stanford University. Dr. He has multidisciplinary research background, such as in physical theory of network evolution, influenza virus, immune repertoire sequencing, single cell genomics and bioinformatics."

Quake's lab is currently dealing with ultra high throughput DNA sequencing. On the lab's web site, a mission statement by Quake said,

"My work in single molecule biophysics led to the first demonstration of single molecule sequencing, and my research in this field has led me to become deeply involved in human genetics, immunology, and the development of new clinical diagnostics."

Quake has not yet responded to a query concerning He Jiankui's work at Stanford.

In the stem cell agency's genomics project, Quake is the lead on a project dealing with cell differentiation.

California's Center for Genetics and Society in Berkeley released a statement on the news about the gene editing. Executive Director Marcy Darnovsky, said, 

“If true, this amounts to unethical and reckless experimentation on human beings, and a grave abuse of human rights. We wish the best for the health of these babies, but strongly condemn the stunt that threatens their safety, and puts the rest of us at risk. Throwing open the door to a society of genetic haves and have-nots undermines our chances for a fair and just future.”

A $59 Million Matter of Fraud and Hubris: The Anversa Stem Cell Story and Its Fallout

Piero Anversa -- NYTimes photo by Annie Tritt

Fabricated stem cell research and its fallout are back in the news this morning with excellent pieces from the New York Times and the Washington Post involving talk of "temptation" and the weakness of prestigious institutions.

First the piece by Gina Kolata in the New York Times,which includes the first substantial interview with Piero Anversa, the former Harvard researcher now identified as having produced more than 30 studies containing falsified or fabricated data dealing with heart research. Kolata wrote,

"Dr. Anversa’s story has laid bare some of the hazards of modern medical research: the temptation to embrace a promising new theory, the reluctance to heed contrary evidence and the institutional barriers to promptly stopping malfeasance. Even after three independent researchers were unable to reproduce his findings in 2004, Harvard hired him in 2007 and his lab continued to churn out studies upholding his theory."

Anversa, 80, is now living in New York. He told Kolata in an interview in his apartment that he did nothing wrong and that he was "betrayed by a rogue colleague who altered data in paper after paper."

Kolata has more from Anversa, but also dives into the history and ramifications of the scandal and its implications involving the culture of science. She described the case as "a particularly acrid cautionary tale of scientific hubris."

A couple of highlights from the piece.

• "'Science at this level is like a battleship, and it’s really hard to turn it around,' said Dr. Jonathan Moreno, a professor of bioethics at the University of Pennsylvania.'People get emotionally invested, financially invested, professionally invested.'" 

• “'This was a perfect storm of ego, wishful thinking and lack of accountability,' said Dr. Jil C. Tardiff, a professor of medicine at the University of Arizona, and a heart-muscle cell researcher."'

 Kolata concluded:

"It did not surprise some in academia that the bold promises of the research persisted despite the contested evidence. 

 "There was an argument in the philosophy of science about whether there is such a thing as a ‘crucial experiment,' said Dr. Moreno, the ethics professor, referring to a study that answers a question once and for all. 

"'It turns out there isn’t. People can see what they want to see.'"

Carolyn Johnson of the Washington Post covered much of the same ground but has more on suspension of a clinical trial related to Anversa's work. Johnson also pointed out that Anversa received $59 million from the federal government for his research. Harvard has since been fined $10 million by the federal government.  

The trial is in the midst of recruiting patients. Johnson wrote,

"The decision to temporarily pause the trial came 'out of an abundance of caution,' said David Goff, director of the Division of Cardiovascular Sciences at the National Heart, Lung and Blood Institute, who said the trial’s scientific rationale is largely based on animal studies not conducted by Anversa.... 

"Goff said the board charged with overseeing the safety and integrity of the trial was convened last week and NIH leadership made the decision to pause the trial, which has enrolled 125 of 144 patients, to allow a thorough review.

"'Our commitment, first and foremost, is to patient safety. We haven’t seen any safety signals related to the cell treatment, but we can’t do any of our research without the partnership of our participants, and we make a commitment to our participants that their safety is our highest priority,' Goff said. The pause will allow the board to examine the trial and 'assure that it continues to meet the highest levels of adherence to participant safety and scientific integrity.'"

Aussie Bioethics Web Site Negative on California Stem Cell Royalties

The California stem cell agency and its royalty news drew attention today from down under in an article that did not exactly view the research effort with warm regards.

The piece appeared on the bioethics blog called Bioedge and was written by Michael Cook, who publishes the web site. He picked up on American news about the royalty matter, largely from the California Stem Cell Report, but also from the $3 billion agency itself.

Cook described the critics as scathing. He concluded,

"During the campaign for Proposition 71, supporters strongly argued that destructive research on human embryos was absolutely necessary for the science to proceed and that cures would certainly come. Almost 14 years later, there have been no cures. The royalty cheque was for a potential therapy for glioblastoma, a deadly brain tumour – but even this not on the market yet. Thus far, it has only passed Stage I clinical trials and been written up in glowing terms in O, The Oprah Magazine."

LA Times: Does California's New Stem Cell Law Do Enough to Regulate Exploitation of Desperate Patients?

The Los Angeles Times this morning carried a piece that praised the state's first-in-the-nation disclosure law concerning unregulated stem cell treatments, but the article also questioned whether the law is tough enough for the task.

Business columnist Michael Hiltzik wrote that the law, which goes into effect in January, is "a major step to address an emerging public health crisis."  But, he continued,

"(T)here’s reason to ask whether California’s law goes far enough to regulate businesses exploiting the desperation of patients with intractable diseases."

The law targets the more than 100 clinics in California that sell what Hiltzik described as  "unlicensed, unproven — and sometimes disproven — stem-cell 'treatments.'" For the first time, such California clinics will be required to disclose to their customers that the treatments are not approved or regulated by the federal government. The notices will advise the customers to consult with their physicians prior to treatment.

Hiltzik,  however, questioned the optimistic wording of the disclosure which says that the treatments have "not yet" been approved by the Food and Drug Administration (FDA). He said,

"This suggests that FDA endorsement may only be a matter of time — that the treatments may be premature, but not fictitious. That’s wildly optimistic and may itself foster a false hope for the treatments."

Hiltzik, a Pulitzer Prize winner,  said the state's Medical Board, which is charged with enforcement, has not been provided with funding to take on the clinics. Plus, he said the board, at best, is a "reluctant regulator."

State Sen. Ed Hernandez, D-Azusa, authored the law. He told Hiltzik the measure is a first step. Hiltzik quoted the legislator as saying,

 “Because it’s so new, we’re trying to figure out the best way to start the conversation.”

Hiltzik concluded,

"But lawmakers and regulators may need to move faster. What will make a difference in California may not be how the conversation starts, but where it leads."

The Smell of Money and Gene Editing of Human Embryos -- Not to Mention the Breakthrough Science

"Horror to be avoided," "superbabies" and "what it means to be human" -- Just some of the language that turned up today concerning the news about the first human embryo editing experiment in the United States. 

Publications ranging from Wired to the Financial Times all had pieces discussing the work led by Shoukhrat Mitalipov of the University of Oregon in collaboration with researchers from California's Salk Institute, China and Korea. A search on Google news this afternoon turned up more than 1,000 citations dealing with the work.

Details of the science can be found in the journal Nature with a critique by UC Davis stem cell scientist Paul Knoepfler on his blog. He praised the research and said it "raises the stakes on future CRISPR use in humans." Elsewhere, the implications of the work also generated both heat and caution.

 The headline on a commentary in the Chicago Tribune said,

"Don't fear the rise of super babies. Worry about who will own genetic engineering technology."

The piece was written by bioethicist Arthur Caplan. He said,

"Freaking out over impending super babies and mutant humans with the powers of comic book characters is not what is needed....How close are they to making freakish super people using their technology? About as close as we are to traveling intergalactically using current rocket technology."

Caplan continued,

"We need to determine who should own the techniques for genetic engineering. Important patent fights are underway among the technology's inventors. That means people smell lots of money. And that means it is time to talk about who gets to own what and charge what, lest we reinvent the world of the $250,000 drug in this area of medicine."

Pam Belluck of the New York Times reported that the findings are "sure to renew ethical concerns that some might try to design babies with certain traits, like greater intelligence or athleticism."

She interviewed Hank Greely, director of Stanford's Center for Law and Biosciences. 

"'If you’re in one camp, it’s a horror to be avoided, and if you’re in the other camp, it’s desirable,' Dr. Greely said. 'That’s going to continue to be the fight, whether it’s a feature or a bug.'

"For now, the fight is theoretical. Congress has barred the Food and Drug Administration from considering clinical trials involving germline engineering. And the National Institutes of Health is prohibited from funding gene-editing research in human embryos."

Marcy Darnovsky, executive director of the Center for Genetics and Science in Berkeley, said in a news release,

"We have not yet engaged in processes that would promote the`broad societal consensus’ about human germline modification that the National Academies of Sciences and other prominent advocates of gene editing have recommended. Until that is achieved, we call on scientists around the world to refrain from research aimed at refining gene editing for use in human reproduction."

Bradley Fikes of the Union-Tribune in San Diego, a hotbed of biotech activity and the home of Salk, wrote that the study

"...brings to a head fundamental questions about what it means to be human, and whether changing the human genome would also change the human identity. And scientists — including those involved in the study — say it’s time for the public to speak up."

Given that this type of research is not funded by the United States government, just where the money came from is of interest. The Salk Institute had the answer. It said in a news release that the funding was provided by the "Oregon Health and Science University, the Institute for Basic Science, the G. Harold and Leila Y. Mathers Charitable Foundation, the Moxie Foundation, the Leona M. and Harry B. Helmsley Charitable Trust, and Shenzhen Municipal Government of China."

Some of the money "compensated" the women who provided the eggs, according to an article by Kelly Servick in the journal Science. Compensation, as opposed to expense reimbursement, is problematic in some areas of research. For example, it is banned in research that is funded by the $3 billion California stem cell agency.

The stem cell agency wrote about the research last week after the findings leaked out early. In February 2016, the agency convened a day-long session to examine issues involving gene editing. Last summer it issued new regulations that say that consent forms involving CIRM research must be modified to include a mention of genetic research. Added was the following phrase: "donated embryos [blastocysts], derived cells or cell products may be used in research involving genetic manipulation."

Regarding the future of the research, Mitalipov told the Financial Times that he wanted to perform regulated clinical trials at some point in the U.S. Unless something changes, he said that “unfortunately this technology will be shifted to an unregulated place."

The Human Egg Business: More Media Coverage of California Cash-for-Eggs Legislation

A renewed legislative effort in California to pay women for handing over their eggs for research is attracting more attention this year, including opposition from a former state senator sometimes called the mother of the state's stem cell agency.

Deborah Ortiz, former chair of the California Senate Health Committee, wrote an op-ed piece published this week in The Sacramento Bee. She noted that the stem cell agency prohibits paying women for their eggs. Ortiz wrote,

"I oppose AB 2531 (the number of the bill) on a number of grounds: First, we have very limited information on the long-term health effects of the egg retrieval process. Second, women who undergo egg retrieval are not research subjects in the traditional sense, as proponents assert. Finally, paying for women’s eggs for research purposes contradicts well-established national recommendations and state policy."

She continued,

"This is not an issue of equity with other research subjects. Women providing eggs for research are not comparable to research subjects in clinical trials. Their role is providing raw materials for pre-clinical research, rather than participating as subjects in medical research. And they are not afforded the safeguards or follow-up of subjects in clinical trials.

"Finally, AB 2531 conflicts with national recommendations and with policies in our state constitution. The 2010 guidelines of the National Academy of Science recommend that no payments beyond reimbursement for expenses be made for donating eggs for research."

Ortiz has been called the mother of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, because of her early role in support of stem cell research and authorship of an initial measure to use bond funding to finance it.

The cash-for-eggs bill also drew attention from Michael Hiltzik, a Pulitzer prize-winning columnist at the Los Angeles Times. He said that the measure should not be approved. Hiltzik wrote,

"There is scant research on the long-term health risks of egg retrieval, and nothing in the bill that would encourage more. To paper over that fact, the measure’s advocates have engaged in a neat bit of obfuscation. Assemblywoman Autumn Burke (D-Marina del Rey), who is carrying the bill for the ASRM, labels it a 'pay equity' bill....

"But it’s not about equity or discrimination. What worries the bill’s critics is that the measure may allow women to be misled into taking uninformed health risks by the prospect of easy cash."

The legislation surfaced at Buzzfeed in a piece by Cora Lewis and Azeen Ghorayshi. They quoted Sean Tipton, a spokesman for the fertility industry group, American Society for Reproductive Medicine (ASRM), that is sponsor of the legislation.

“'It’s (the bill is) needed to correct a strange and outdated feature in California law.'...Women are paid when they donate eggs to make babies, and people are paid when they are research subjects, he noted. 'But if you combine the two, you can’t be compensated. I don’t think that makes any sense,' Tipton said."

Another piece appeared on the Undark web site. It was written by Diane Tober, an assistant professor at UC San Francisco. She wrote,

"As a researcher myself, I can sympathize with the seduction of discovery, and the lure of developing new technologies and treatments that stem cell research may offer society at large. The millions of dollars of funding available to support such research would also be enticing.

"But the history demonstrates that the burden of human experimentation has rested on the shoulders of the socially and economically disadvantaged. The focus of AB-2531 is to obtain eggs for research, but it ignores the need for research into the impacts of the myriad drugs and procedures used to coax and extract those eggs in the first place." 

Leading the drive against the measure, vetoed by Gov. Jerry Brown in 2013, is the Center for Genetics and Society in Berkeley. It is circulating a flyer aimed at California lawmakers that says,

"This bill incentivizes invasive procedures that expose women to substantial short-term and unknown long-term health risks."

Brown has given no indication that he has changed his position on the measure.

NY Times: Stem Cell Theory vs. Flourishing, Dubious Stem Cell Clinics

The New York Times this morning took a crack at coverage of the first-ever study of the wave of dubious stem cell clinics in America. The headline on the Times' prominently displayed story said,

"Stem Cell Therapies Are Still Mostly Theory, Yet Clinics Are Flourishing"

The starting point for the article by Gina Kolata was the study by UC Davis stem cell researcher Paul Knoepfler and bioethicist Leigh Turner of the University of Minnesota.  They reported on June 30 that nearly 600 dubious stem cell clinics have sprung up around the country. It is the first study to document the reach of these businesses. The report, published in the scientific journal Cell Stem Cell,  received heavy mainstream media coverage.

Kolata highlighted the tentative nature of stem cell research. She wrote,

 "In theory, stem cells might be a useful treatment for certain diseases that involve the loss of cells, like Type 1 diabetes, Parkinson’s or osteoarthritis. They are primitive cells that can develop into a range of mature cells and perhaps serve as replacements. But progress is slow. After a flurry of stem cell excitement two decades ago, almost all the research today is still in mice or petri dishes. The very few clinical trials that have begun are still in the earliest phase.

"The problem is that stem cell therapies are still mostly theory. So what is going on? How can there be clinics, even chains of clinics run by companies, offering stem cell treatment for almost any disease you can think of — sports injuries, arthritis, autism, cerebral palsy, stroke, muscular dystrophy, A.L.S., cancer?"

She said that the Knoepfler-Turner study showed "what can happen when regulations fall behind." 

And she noted the limits of federal regulation as well as the failure of state regulatory bodies to deal with the issue. 

Kolata's story was displayed online this morning on the main page of the New York Times. The media attention to the work by Knoepfler and Turner has significantly raised the visibility of the issues involving dubious stem cell "therapies."  A narrowly defined search on Google news this morning turned up nearly 11,000 citations, up from about 7,000 early this month.

The coverage certainly has increased the likelihood of some sort of additional regulatory action. However, such moves take time, and it is not realistic to expect a crackdown anytime soon. Indeed, it may require legislative changes at the federal and state levels.

As for the ethical and medical concerns raised by Knoepfler and Turner and the Times piece, one Times reader -- identified online only as Susan -- said,  

"So what? A lot of what the scientific/medical establishment tries to sell us is just theory. Studies of this and studies of that. A study will come out and 6 months later another study will come out debunking the first study. I believe the problem is that some of these science/medical 'experts' are under the delusion that 'one size fits all.' I disagree. What may kill one person may help another."

Pay-for-Eggs Legislation Up Again in California: Fertility Industry Trying to Repeal Ban on Compensation for Human Eggs in Research

The industry that deals in human eggs is once again pushing forward with California legislation to allow it to pay women thousands of dollars to harvest their eggs for research purposes.

The measure (AB2531) by Assemblywoman Autumn Burke, D-Inglewood, is now on the Assembly floor after clearing the Assembly Health Committee on a 17-0 vote. (See the March 31 legislative analysis of the measure here.)

The bill is essentially the same as the one vetoed by Gov. Jerry Brown in 2013. It is not clear whether the current author of the measure has been successful in removing Brown’s opposition.

The legislation is sponsored by American Society for Reproductive Medicine, the dominant trade group in the largely unregulated fertility industry.

When she introduced her bill in February, Burke said in a press release,

Autumn Burke on Assembly floor
Sacramento Bee photo

"It's perfectly legal for a woman to get paid when advertising through Craigslist to provide eggs for infertile couples, but she can't get paid for a donation in medical research. It's insulting to women, and it keeps California's research institutions in the dark ages. Instead of leading the way on women's health, we're stuck behind 47 other states all because of a misguided ban that assumes women shouldn't be allowed to make their own decisions."

Burke and the industry organization have an array of groups backing the legislation, ranging from California's district nine of  the American Congress of Obstetricians and Gynecologists to California Cryobank.

The bill is opposed by the Center for Genetics and Society in Berkeley along with groups ranging from the Catholic church to "We Are Egg Donors."

Marcy Darnovsky, NBC photo

Earlier this month, Marcy Darnovsky, executive director of the Center for Genetics and Society, wrote:

"The health risks of egg harvesting are significant, but they’re woefully under-studied. A well-known and fairly common short-term problem is ovarian hyper-stimulation syndrome (OHSS), but no one is sure how many women get the serious – sometimes life-threatening – version of it. Data on long-term outcomes, including follow-up studies on reports of cancers and infertility in egg providers, are notoriously inadequate.

"It is impossible for women to give truly informed consent if adequate health and safety information can’t be provided.

"Offering large sums of money encourages women in need to gamble with their health. It’s what bioethicists call 'undue inducement.'"

California's $3 billion stem cell agency bans compensation for women who provide eggs for research that the agency finances but it does allow reimbursement of expenses. The legislation would repeal a state law banning compensation.

(Editor's note: The original version of this story said that Brown vetoed an egg compensation bill last year instead of 2013.)

LA Times on California's Stem Cell Agency, Biotech Gold Rush and Genetically Altering Human Embryos

The Los Angeles Times, which largely ignores the $3 billion California stem cell agency in its news columns, is carrying a piece this weekend that says the agency is considering “work so controversial that the federal government won’t pay for it.”

The reference is to the possibility of the state of California financing research that involves the editing of genes in human embryos, which the agency began to explore at some length at a Feb. 4 meeting in Los Angeles.

The Feb. 12 Times story, written by Melody Petersen, is straight news piece that recaps the controversy about the possibility of making heritable changes in human beings through the use of CRISPR technology. She also covered how the agency intends to proceed with its review.

Peterson described how businesses are embracing CRISPR,

“It has set off a biotech gold rush as scientists imagine its commercial uses and found start-up companies that are attracting hundreds of millions of dollars in venture capital.”

Peterson also wrote about the likelihood of heritable changes in embryos, interviewing Marcy Darnovsky, executive director of the Center for Genetics and Society in Berkeley. She quoted Darnovsky as saying,

"This is not safe. It's still way too early to try such an experiment on a human being."

Peterson continued,

“The agency's current regulations say that no money can be used to transfer a genetically modified human embryo to a woman to start a pregnancy. But some experts worry that agency-funded researchers could later turn to other sources to finance the reproductive stage of their work.

"'If you have genetically modified embryos in labs around the state,’ Darnovsky said, ‘what's to stop them from being used to initiate a pregnancy?"

Peterson quoted Kevin McCormack, senior director for communications at the stem cell agency, as saying, "So far we have not funded any research that involves CRISPR, nor have we received any proposals for funding using that technology. But that's probably just a matter of time."

The stem cell agency has longed struggled with a lack of news media attention. It would like to spread the word about what it considers its good works, such as the well over $500 million it has pumped into enterprises in the immediate Los Angeles area. The LA Times is an especially important medium because it is the largest circulation newspaper in the state, has an enormous Internet presence and helps to drive what is covered by other outlets.

But given the state of the media nowadays and the shrinkage in science reporting, about all the agency can really expect for now is coverage when something extraordinary happens or when there is the likelihood of something extraordinary happening such as genetic changes being made in human embryos.

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

Legal Setback for California Stem Cell Business Snared in Abortion Flap

A California stem cell/human tissue firm appears to be losing its battle to halt damaging videos that have entangled it in an emotional national controversy about abortion, the Washington Post reported today.

An opinion piece by UCLA law professor Eugene Volokh said that the Los Angeles judge in the case “seems to have been persuaded” by the anti-abortion activists to refrain from blocking further distribution of the videos involving StemExpress LLC of Placerville.

Quoting from the judge’s tentative ruling last week, Volokh noted that the First Amendment issues in the case apparently are carrying the day even if the activists violated state law in making the surreptitious videos. The Washington Post piece provided a link to the response by the Center for Medical Progress, an Irvine organization behind the videos. ­­­­­

Text of StemExpress Statement on Cutting Ties to Planned Parenthood

Here is the text of the full statement from StemExpress as provided to the California Stem Cell Report by a spokesman for the firm. 

"StemExpress statement Regarding Termination of Agreements With Planned Parenthood

"StemExpress at its core is a small life sciences company committed to accelerating research, advancing medicine, and saving lives. We partner with organizations also seeking to help researchers find solutions to some of life's most significant medical conditions and diseases. Our commitment to quality defines us and is demanded by our customers in the research community. 

"We value our various partnerships but, due to the increased questions that have arisen over the past few weeks, we feel it prudent to terminate activities with Planned Parenthood. While we value our business relationship with Planned Parenthood, that work represents a small percentage of our overall business activity and we must focus our limited resources on resolving these inquiries.

"StemExpress works tirelessly to accelerate the speed of helping patients globally: 7.6 million people die of cancer each year, another 7.4 million of heart disease, over 4.6 million from lung cancer, AIDS and diabetes and every 12 minutes another name is added to the national transplant waiting list. These numbers drive our work and the research community. StemExpress looks forward to the swift resolution of all inquiries and audits so we can focus our full attention on helping the medical and research community improve and save lives."

California's StemExpress Cuts Links with Planned Parenthood in Anti-Abortion Flap

A California stem cell/human tissue firm has severed its ties with Planned Parenthood in the wake of a national, anti-abortion controversy, the Politico Web site reported late today.

Politico writer Jennifer Haberkorn cited a statement from StemExpress LLC of Placerville, which said,

“We value our various partnerships but, due to the increased questions that have arisen over the past few weeks, we feel it prudent to terminate activities with Planned Parenthood. While we value our business relationship with Planned Parenthood, that work represents a small percentage of our overall business activity and we must focus our limited resources on resolving these inquiries.”

The statement has not been posted on the company’s Web site as of this writing.  (Shortly after this item was published, a spokesman released the text of its statement, which can be found here.)

The company has said in court that it has suffered damage and its executives have been threatened with violence as a result of Internet videos that were made surreptitiously by anti-abortion activists. The activists used fake names and a fake company to gain access to Planned Parenthood officials. StemExpress was identified as one of the purchasers of fetal tissue from Planned Parenthood.

Investigations into the company and Planned Parenthood have been launched by the Senate and the House. The issue has come up in the 2016 presidential race. The U.S. Department of Justice and the California attorney general are looking into whether privacy laws were violated by the anti-abortion activists.

The company has been vilified on the Internet. The latest posting involved a video of a former employee of StemExpress, Holly O’Donnell, who said that “she once saw another technician appear to obtain fetal tissue without a patient’s consent,” Politico reported. StemExpress “unequivocally” denied the claim two days ago.

The firm said,

“Like all of their previous material, (the) video by (the activists) is deceptively edited and falsely worded to suggest impropriety or illegality where none exists. (Their) continued efforts to malign StemExpress—a life-sciences company that predominantly supplies adult cells, blood and tissue to the nation’s leading researchers—will only serve to slow the pace of life-saving medical research aimed at curing disease and extending quality of life for millions of Americans.”

Earlier this week, the activists lost a bid to overturn a temporary restraining order against them. StemExpress said they also “refused to produce witnesses for depositions or respond to document requests previously ordered” by the Los Angeles superior court.

Three California Human Tissue Firms Targeted by House Committee

A Republican-dominated Congressional committee today zeroed in on three California human tissue firms entangled in the national flap over abortion and the Planned Parenthood Association.

All three were sent letters today seeking to determine whether the companies were in compliance with laws dealing with the distribution of fetal material.  They were given a deadline of Aug. 21 to provide a briefing to the House Energy and Commerce Committee.

Questions include procedures involving informed consent from donors, fees for fetal tissue, the amount of revenue from fetal tissues in 2014 along with policies and practices for handling fetal tissue.

StemExpress of Placerville, east of Sacramento, and its president Cate Dyer, received one of the letters. The stem cell and tissue firm has been much in the news about the controversy. The flap was triggered by Internet videos with Planned Parenthood officials that were taped surreptitiously by anti-abortion activists using false identities and false company credentials.

Both the federal and California departments of justice are investigating whether the anti-abortion activists violated the law when they made the undercover videos. 

The other two letters went to Linda Tracy, president of Advanced Bioscience Resources, Inc., of Alameda, and Ben Van Handel, executive director of Novogenix Laboratories, LLC, of Los Angeles. (See the letter to Advanced here, the letter to Novogenix here.)

The letters to StemExpress and the Advanced Bioscience referred to a July 27, New York Times article that included them. The House committee letter quoted from the piece.

The article by Denise Grady and Nicolaus St. Fleur said, 

"(F)etal tissue is a uniquely rich source of the stem cells that give rise to tissues and organs, and that studying how they develop can provide clues about how to grow replacements for parts of the body that have failed.

“'Think of fetal tissue as a kind of instruction booklet,' said Sheldon Miller, the scientific director of the intramural research program at the National Eye Institute.

"Stem cells derived from adult tissue may eventually replace fetal ones, researchers say, but the science is not there yet."

All three companies were told by the House committee,

“Under the NIH Revitalization Act of 1993, it is "unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the
transfer affects interstate commerce." While this provision prohibits the sale or purchase of fetal
tissue itself, the term "valuable consideration" does not include reasonable payments associated
with the transportation, implantation, processing, preservation, quality control, or storage of
human fetal tissue. As the committee with legislative jurisdiction over the NIH Revitalization
Act of 1993, we have an oversight responsibility and interest in determining whether there is
adequate compliance with the law, and/or whether the law is adequately meeting ethical and
moral concerns." 

A Reuters story said that none of the companies has responded to a request for comment.

National Controversy Snares California Stem Cell Firm; Congressional Investigation, Presidential Politics Involved

A California stem cell firm is enmeshed today in a national flap linked to abortion, buying and selling body parts and the 2016 presidential race.

The firm is StemExpress of Placerville, just east of Sacramento in the Sierra Nevada foothills. It was mentioned in a YouTube video that was recorded secretly by abortion foes who were posing undercover in a discussion with Planned Parenthood officials.

The video has been viewed nearly two million times as of this writing. The New York Times, the Washington Post and other major news outlets are covering the story.  It has triggered virulent headlines on anti-abortion and conservative web sites.

One headline on inquisitor.com said in red type,

“Buying And Selling Aborted Fetus Body Parts For $30 To $100? ‘Stem Express’ Website Down After Undercover Video Exposes Planned Parenthood” 

StemExpress provides researchers with “high-quality stem cells they need for their research,” an employee of the firm told the California Stem Cell Report in an email last May.  The firm also supplies “human blood, tissue products, primary cells and other clinical specimens to biomedical researchers around the world,”

Reporter Sammy Caiola wrote today in The Sacramento Bee,

“The eight-minute undercover clip, which has garnered over 1 million views (as of yesterday) and inspired the popular anti-abortion Twitter hashtag ‘#PPSellsBabyParts,’ is edited in a way to suggest Planned Parenthood and its affiliates profit from fetal tissue and organs procured during abortions, which is against federal law.”

Caiola said that the video contains “a supposed image of the StemExpress website (that) shows an order form, where users can designate type of order, number of specimens, tissue type and shipping options.”

Caiola continued,

“In a statement released by Planned Parenthood, spokesman Eric Ferrero said that while many women who undergo abortions choose to donate fetal tissue to scientific research, there is no financial benefit for either the patient or Planned Parenthood. Sometimes, Planned Parenthood is reimbursed for the cost of transporting the tissue to labs, he said.

“’We do this just like every other high-quality health care provider does – with full, appropriate consent from patients and under the highest ethical and legal standards,’ Ferrero said.” 

The California Stem Cell Report this morning asked StemExpress for comment and will carry it verbatim when it is received. However, all of the news stories so far say that the company has not responded to similar requests.

(The company responded -- see here for full text -- just as this item was posted and said,

"StemExpress prides itself on complying with all laws. Our compliance protocols and donor consents have been established by an FDA-compliant Independent Review Board. Written donor consent is required for any donation, including bone marrow, tissue of all types or blood."

(The company also said,

"Everything we provide is solely at the request of the nation’s and the world’s great research institutions. Producing the isolated cells researchers need from donated tissues requires the development of complicated, often unique, research techniques using millions of dollars of scientific equipment. We are hopeful the events of the last few days will not diminish our efforts to support the research community or hinder our partners from continuing their important work.")

The company was founded in 2010 by Cate Dyer.  Inc. magazine ranked the firm 363rd on Inc. magazine’s list of the fastest-growing private companies in America last year.

Ariana Eunjung Cha of the Washington Post wrote that GOP presidential hopefuls Ted Cruz, Jeb Bush, Ben Carson and Bobby Jindal all have spoken out on the controversy.

In Congress, Republican leaders have ordered an investigation. Jackie Calmes and Nicholas St. Fleuer of the New York Times said,

"House Republican leaders on Wednesday announced a congressional investigation of Planned Parenthood, a day after anti-abortion activists released a video of an unsuspecting official from the organization explaining how it provides fetal tissue to researchers.
 "Echoing the activists’ allegation, Speaker John A. Boehner and other top Republicans suggested that Planned Parenthood was selling fetal parts, which is illegal if done for profit. But Planned Parenthood said that while it charges for expenses such as processing and transporting, it makes no money from the fetal tissue donated by women who get abortions. The official shown in the video repeatedly says something similar to two activists posing as biotechnology representatives."

California Stem Cell Agency Symposium: 'Vague Fears' vs. Potential Genetic Alteration of Human Race

California’s $3 billion stem cell agency has called a high-level meeting for next fall to examine a
"red-hot" issue that many prominent researchers say could lead ultimately to alteration of the human race.

The topic is a technique that makes it much easier to alter the genetic make-up of individuals in a way that can be inherited by their offspring.

In April, scientists in China reported genetically modifying human embryos in what was regarded as a “world first.” (See here and here.)

That came after a group of leading scientists in March called for a global moratorium on the genome-editing practice, stating that the therapeutic benefits were tenuous.

More recently Marcy Darnovsky, executive director of the Center for Genetics and Society in Berkeley, wrote on May 28 about how the subject was viewed at a meeting called, “Biotech and the Ethical Imagination: A Global Summit.”

Steven Pinker

“The far end of techno-enthusiastic perspectives, both on human germline modification specifically and on biotech in general, was represented by Harvard experimental psychologist and popular science writer Steven Pinker. In his opening remarks, Pinker counseled bioethicists to ‘stay out of the way of progress.’ In his closing comments, he cast ‘vague fears’ as standing in the way of saving millions of lives. In between, he epitomized the ‘bad boy scientism’ that too frequently characterizes the biotech field.” 

Jonathan Thomas, chairman of the stem cell agency, and Geoff Lomax, the agency’s main person on bioethics, wrote on June 1 about the matter and the upcoming meeting. In an item on the agency’s Stem Cellar blog, they said,

“Given CIRM’s support for research activities where genome editing may be employed, we believe it is important to have effective policies to guide our future funding decisions. Therefore, we have charged the CIRM Medical and Ethical Standards Working Group with convening a public workshop to elucidate the scientific and policy considerations surrounding genome editing in the context of CIRM supported research. This workshop is a first step in evaluating whether CIRM should make changes to its existing policies governing stem cell research.”

 CIRM’s standards group consists of some of the top bioethicists in the country. Early on, they developed the agency’s rules for research on stem cells, which were the most advanced in the country at the time. The chairman of the group is Bernie Lo of UC San Francisco.

The genome-editing issue to be discussed in November was originally scheduled to be brought up at an April meeting of the standards group. However, it was put off for a variety of reasons. Thomas subsequently called the meeting for next fall.

At the April meeting, Ted Peters of the Pacific Lutheran Theological Seminary and a member of the stem cell standards group, said the issue was “red hot.”  Jeff Sheehy, a member of the agency board and a communications manager at UC San Francisco, said the agency needed to clarify where it stood.  

Robert Taylor of the Emory School of Medicine and also a member of the standards group, said,

“There are companies that are offering to do this for your cell line, so it's really out there.”

Lo said,

“I think Jeff has raised a really important, complex and breaking topic. I think the idea of having a symposium to deal with both the science, and the ethics policy could be a really important thing to do.” 

 Suggestions regarding the meeting can be sent to Lomax at glomax@cirm.ca.gov. 

'Born in Hype:' The California Experiment and Stem Cell Research

A California newspaper with a daily readership of 1.5 million this week thrashed the field of stem cell science, declaring that it “is slathered with so much money that immoderate predictions of success are common.”

“Infected with hype” is the way the headline put it on the March 31 piece in the Los Angeles Times. The paper has the largest circulation in the state and is an agenda-setter for much of the state’s mainstream media.

The comments came in an article by Pulitzer Prize-winning columnist and author Michael Hiltzik, who holds the California stem cell agency in low regard.

Kalina Kamenova
 U. of Alberta photo

Timothy Caulfield
U. of Alberta photo

His starting point was a study in Science Translational Medicine by Timothy Caulfield and Kalina Kamenova of the University of Alberta law school.  Their content analysis research focused primarily on newspaper coverage of timelines for stem cell therapies before and after Geron bailed out of the first clinical trial for a human embryonic therapy in the United States. They did not have warm words for scientists as public communicators.

Neither did Hiltzik, but he also faulted the media. He wrote, 

“The authors mostly blame the scientists, who need to be more aware of ‘the importance of conveying realistic ... timelines to the popular press.’ We wouldn't give journalists this much of a pass; writers on scientific topics should understand that the development of drugs and therapies can take years and involve myriad dry holes and dead ends. They should be vigilant against gaudy promises.”

Hiltzik then took on the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is known.  He wrote about the cash that was "slathered" about. He said,

“The best illustration of that comes from California's stem cell program -- CIRM, or the California Institute for Regenerative Medicine -- a $6-billion public investment (including interest) that was born in hype. 

“The promoters of Proposition 71, the 2004 ballot initiative that created CIRM, filled the airwaves with ads implying that the only thing standing between Michael J. Fox being cured of Parkinson's or Christopher Reeve walking again was Prop. 71's money. They commissioned a study asserting that California might reap a windfall in taxes, royalties and healthcare savings up to seven times the size of its $6-billion investment. One wouldn't build a storage shed on foundations this soft, much less a $6-billion mansion.”

 He wrote about how CIRM played a dubious role in funding the Geron clinical trial only a couple of months before the company pulled the plug for financial reasons, something that the California Stem Cell Report has dealt with as well.  The $26 million loan to Geron involved a major departure from the agency’s normal procedures.  Abandonment of the trial also raised ethical questions that should be of continuing concern to the agency and its ethical advisors who are meeting today and tomorrow in Los Angeles.  

Caulfield’s views on stem cell hype are well-known in the small stem cell research community. But rarely does his sort of perspective, which is shared by others in the field, reach a mass audience such as the 1.5 million readers of the Los Angeles Times.

All of which poses a challenge for the California stem cell agency whose finite amount of cash is now expected to run out in 2020. As Hiltzik noted, the overblown expectations led voters to believe that miraculous cures were just around the corner.

Today, more than a decade after creation of the agency, the promised cures have not materialized and none are likely for some years. The agency has undoubtedly made a major contribution to stem cell science. But the unfulfilled promises of the campaign hype gave its foes the kind of tools they need to battle any efforts to provide more state funding for the agency.  How CIRM deals with that scientific and PR challenge will be one of the major tests for it over the next several years.