OAKLAND, Ca. -- "Phantom equity," the affordability of $1 million cures, maximizing returns to the state and conflicts of interest -- all that and more was on the table today at the $3 billion California stem cell agency.
The occasion was a discussion of "ideas for enhancement" by some of the directors of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known.
This was more than simply kicking around possibilities. The meeting was called because the agency expects to run out of money for new awards later this year.
Its hopes for financial survival rest largely on a possible $5 billion bond initiative on the November 2020 ballot. Writing an initiative also means an opportunity to improve agency operations. To pass an initiative, California voters would also need to be inspired by the work the agency has done and how it will do even better in the future.
So the governing board put together today's session to hash over ideas, starting with a 10 page list of initial thoughts. No decisions were reached, however. The discussion will carry on next Thursday at a meeting of the full board, which will also be held in CIRM's 16th floor offices here. But internally the agency plans to begin to explore some of the areas in more depth.
The implications of changes could have a major impact not only on California researchers but biotech businesses looking for possible products that could generate profits, preferably large ones.
One area of concern by CIRM directors was maximizing the return to the state for its $6 billion investment, which includes the interest on the $3 billion borrowed for the CIRM program. One of several suggestions included the use of "phantom equity," a loose term that implies having an investment but not ownership in a company that is tied to the value of its shares. (CIRM is barred from actually owning stock.)
At the same time, directors also said they did not want to raise financial obstacles that would stop biotech firms from turning CIRM research into cures.
CIRM Director Jeff Sheehy, who has served on the board since its inception in 2004, brought up affordability and access suggestions by the man who led the 2004 campaign, Robert Klein.
In a recent interview with the California Stem Cell Report, Klein said he was interested in seeing more stringent requirements to assure that state-backed therapies are available to all. Esimates of costs of some legitimate stem cell treatments have ranged up to $1 million or more.
Another subject of some discussion was the matter of perceived conflicts of interest involving the current structure of the CIRM board. About 90 percent of the awards made by CIRM have gone to institutions with links to members of the board. While some board members acknowledged the importance of perceptions, they said no conflicts of interest have actually occurred.
A proposed initiative will have to be filed late this year in order to qualify for the November 2020 ballot. In the interview with Klein, he said he was looking at filing around the middle of September.
Wednesday, May 15, 2019
California Stem Cell Crossroads: A Researcher Muses About the Golden State's Research Program
OAKLAND, Ca. -- A California stem cell researcher weighed in this morning on the future of the state's $3 billion stem cell agency, a topic that its leaders will delve into here today for two hours.
Paul Knoepfler, writing on his blog, said,
Knoepfler speculated about other sources of fund, including some from the legislature and possible private support. He wrote,
Paul Knoepfler, writing on his blog, said,
"We are at a crossroads for stem cell research in California as the original form of the California Stem Cell Agency (CIRM)winds down. Will CIRM get a new infusion of billions in state funding via a ballot initiative a la Proposition 71 from more than a decade ago? Will CIRM instead find a different source, probably much smaller, of research funding such as via philanthropy? Could CIRM cease to exist within a few years?"Knoepfler is a longtime supporter of the agency. He wrote,
"CIRM has such strong clinical momentum right now, I hope it continues robustly for another 10 years."The agency, however, expects to run out of cash for new awards late this year. It is pinning its hopes on a possible $5 billion ballot measure in November 2020.
Knoepfler speculated about other sources of fund, including some from the legislature and possible private support. He wrote,
"While California has been very successful in getting NIH research funding for stem cell research by individual labs, the feds don’t fund state-wide efforts. The stem cell-related biotech industry in California is robust and should there be a few blockbuster successes from ongoing clinical trials here, which I expect will occur in the coming decade, this will likely draw in much more funding in that area."
Knoepfler also discussed the impact of "snake oil" stem cell clinics on the future of the agency.
"In my view," Knoepfler said, "a newly funded CIRM is also going to have to deal directly with the unproven stem cell clinic problem in our state. With more than 100 such clinics here, Californians are at risk but so is stem cell research funding from these rogue efforts. The new bill on stem cell clinics could be the ticket, should it become law."
The California Stem Cell Report will be covering live this morning's hearing on the agency's and will file reports as warranted.
Tuesday, May 14, 2019
California Eyes "Makeover" -- Sort Of -- For Its $3 Billion Stem Cell Research Program
One might say that the $3 billion California stem cell agency is going into the botanical business this week. That's because tomorrow it will be "let-a-thousand-flowers-bloom" time at the agency.
Robert Klein, who led the 2004 campaign and was the agency's first chairman, has indicated that he is once again ready to move forward on a new campaign. He offered other ideas involving a new initiative in an interview recently with the California Stem Cell Report.
As for the "thousand flowers" business, that is a phrase that is often attributed to Chairman Mao who reportedly actually said 100 -- not 1,000. His remark came in 1957 and was ripe with financial and political implications. So it is once again this week in connection with ideas for what could be CIRM 3.0.
For a start, the agency has posted 10 pages of "ideas for enhancement" of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known. And it wants even more suggestions.
The initial ideas include barring persons from sitting on the CIRM governing board who have connections to institutions that receive CIRM funds. Others involve creation of a mechanism that would permit CIRM to act more like a venture capitalist.
Still others include topics such as the current 6 percent administrative budget cap, prohibitions on CIRM owning stock, restructuring the research application review process and the expense of renting office space, which drove the agency from its previous headquarters in San Francisco.
The wide-ranging discussion, scheduled for two hours, is driven by the fact that CIRM will run out of money for new awards this year, possibly as early as September. The agency is hoping for passage of a new ballot initiative in the fall of 2020 that will provide it with $5 billion more.
A fresh, citizen-written initiative means an opportunity to recast CIRM from version 2.0 into version 3.0 with improved abilities to develop stem cell therapies, to deal with the changing economics of medicine and to fix things that weren't quite right in Proposition 71, the 2004 measure that created the agency.
"CIRM has a unique perspective to offer regarding possible enhancements to Proposition 71 that might further CIRM’s mission more efficiently and improve its operations," the agency said in a document prepared for tomorrow's meeting.The agency also that said that the ideas offered in advance "are intended to spark discussion and are not intended to limit discussion topics."
Robert Klein, who led the 2004 campaign and was the agency's first chairman, has indicated that he is once again ready to move forward on a new campaign. He offered other ideas involving a new initiative in an interview recently with the California Stem Cell Report.
As for the "thousand flowers" business, that is a phrase that is often attributed to Chairman Mao who reportedly actually said 100 -- not 1,000. His remark came in 1957 and was ripe with financial and political implications. So it is once again this week in connection with ideas for what could be CIRM 3.0.
Tomorrow's meeting will be carried live and interactive on the Internet. Members of the public will be able to listen in and comment. Instructions are on the agenda.
The meeting will be based in Oakland with teleconference locations for CIRM board members, which the public can share, in Riverside, South San Francisco, San Diego, Napa, San Francisco, Irvine, La Jolla and Rancho Cordova. Specific addresses can be found also on the meeting agenda.
The meeting will be based in Oakland with teleconference locations for CIRM board members, which the public can share, in Riverside, South San Francisco, San Diego, Napa, San Francisco, Irvine, La Jolla and Rancho Cordova. Specific addresses can be found also on the meeting agenda.
Monday, May 13, 2019
Stem Cell Treatments on the Installment Plan, Cash for Patient Families, State Grants for Stem Cell Training? Perhaps Part of a New, $5 Billion California Ballot Measure
In November 2017, Robert Klein appeared before directors of the California stem cell agency to discuss a new bond initiative for the agency. He had more to say last month. See story below.
California Stem Cell Report photo.
They include a stronger requirement to make state-backed, stem cell therapies more affordable and accessible and to provide more cash for creating a greater stem cell work force in the Golden State.
Robert Klein, the real estate investment banker who led the formulation of the 10,000-word ballot initiative that created the stem cell agency, recently told the California Stem Cell Report,
"The original initiative stated really a commitment to the idea of access....
"It's my intention to actually put a directive in for funding the infrastructure to work on access, to work with insurance companies, to work with Covered California to work with Medicare, to make sure that there's access, to make certain that public hospitals and public clinics in California get discounted prices."
Klein discussed some of his thinking for another ballot initiative in 2020 during a 70-minute interview last month in the offices of Klein Financial Corp.
Also housed in his building is the office of Americans for Cures, a nonprofit stem cell advocacy group. Klein, who founded the group and is its chairman, said he is consulting with its scientific advisory group to develop possible changes in CIRM.
The co-chairs of the group are Irv Weissman, director of Stanford's Institute of Stem Cell Biology and Regenerative Medicine, and Larry Goldstein, director of the UC San Diego stem cell program.
Klein's thoughts on affordability and access were expansive.
Also housed in his building is the office of Americans for Cures, a nonprofit stem cell advocacy group. Klein, who founded the group and is its chairman, said he is consulting with its scientific advisory group to develop possible changes in CIRM.
The co-chairs of the group are Irv Weissman, director of Stanford's Institute of Stem Cell Biology and Regenerative Medicine, and Larry Goldstein, director of the UC San Diego stem cell program.
Klein's thoughts on affordability and access were expansive.
"We need to also address the issue of how do patients get treatment. They need transportation to get there right? They need housing for their family member who's going to take care of them."As for possible costs of $1 million for a single treatment, Klein called for fresh thinking in terms of insurance coverage and financing. He notes that stem cell therapies can result in a total cure, eliminating the need for recurring, expensive treatments. He said,
"These curative therapies -- we need to work on a new business model for biotech where instead of paying $500,000 upfront or something where companies price it."As for payments by insurance companies for treatments, Klein said,
As long as you're in remission from cancer, they pay for it, but they pay for it over a period of five years or 10 years. Right? It’s pay for performance and medicine, which is important to access. Right?"As for training medical professionals to handle what Klein hopes will be a burgeoning industry, he said,
"I'm looking at a directive section that deals with specifically broadening the doctors who are specifically educated. The only way you can do that is to buy a part of the residency time. Otherwise they don't have time to do anything other than deal with current patients and current methodologies, which are radically insufficient as compared to the new cellular therapies.
"In terms of having the workforce that can implement these new therapies.... You need individuals that are trained in high speed cell sorters. You need individuals that understand the handling of cellular therapies, keeping frozen transportation, the procedures within the operating rooms on delivery, specific structures that have been created to be able to precisely insert them at the right place."Klein, who was the first chairman of CIRM, has more ideas that may well be aired at a CIRM meeting Wednesday to discuss a possible $5 billion bond initiative to rescue the agency from financial death.
The bond funds that were authorized in 2004 are expected to run out for research awards as early as September.
Wednesday's meeting involves the science and governance committees of the agency's 29-member board. The session will be aired live over the Internet. The public can participate as well. Instructions are available on the agenda.
The meeting will be based in Oakland with teleconference locations for CIRM board members, which the public can share, in Riverside, South San Francisco, San Diego, Napa, San Francisco, Irvine, La Jolla and Rancho Cordova. Specific addresses can be found also on the meeting agenda.
Sunday, May 12, 2019
$15.6 Million Operating Budget Slated for California's Stem Cell Agency
California's 14-year-old stem cell research program is set this week to approve a $15.6 million operating budget as its funding is drawing to a close.
Cash for new research awards is expected to run out later this year. But the agency, known formally as the California Institute for Regenerative Medicine (CIRM). still needs to administer multi-year awards for the next few years. It has set aside money to wind down those existing programs.
The proposed operating budget for the 12 months beginning July 1 totals $15.6 million, up from an expected $14.9 million in spending in the 2018-19 fiscal year. The budget is slated to taper down to $1.8 million in 2023-24.
For the new fiscal year, employee salary and benefits consume most of the budget, accounting for $11.4 million, up slightly from $11.3 million this year. The most recent body count at CIRM shows about 45 employees.
The second largest spending category for next year is "external services," largely outside contracting. That area totals $1.5 million, up from $1.1 million for the current year.
The 2019-20 budget provides $838,000 for grant application reviews, meetings and workshops. That is up from $794,000 this year.
The $838,000 appears to assume the success of a private, $220 million fundraising drive that is now underway. It would allow the agency to continue its awards in a significant fashion. However, no public announcement of any major fund donations has yet been forthcoming.
The budget comes before the Finance Committee of the agency's governing board on Wednesday. The committee routinely approves the annual operating budget with few, if any, major major changes. The spending plan will then go to the full board next month for ratification.
More details of the budget can be found on the agenda for the meeting. The session will be aired over the Internet. The public can listen in and ask questions online as well. Instructions for participating can be found on the agenda.
Cash for new research awards is expected to run out later this year. But the agency, known formally as the California Institute for Regenerative Medicine (CIRM). still needs to administer multi-year awards for the next few years. It has set aside money to wind down those existing programs.
The proposed operating budget for the 12 months beginning July 1 totals $15.6 million, up from an expected $14.9 million in spending in the 2018-19 fiscal year. The budget is slated to taper down to $1.8 million in 2023-24.
For the new fiscal year, employee salary and benefits consume most of the budget, accounting for $11.4 million, up slightly from $11.3 million this year. The most recent body count at CIRM shows about 45 employees.
The second largest spending category for next year is "external services," largely outside contracting. That area totals $1.5 million, up from $1.1 million for the current year.
The 2019-20 budget provides $838,000 for grant application reviews, meetings and workshops. That is up from $794,000 this year.
The $838,000 appears to assume the success of a private, $220 million fundraising drive that is now underway. It would allow the agency to continue its awards in a significant fashion. However, no public announcement of any major fund donations has yet been forthcoming.
The budget comes before the Finance Committee of the agency's governing board on Wednesday. The committee routinely approves the annual operating budget with few, if any, major major changes. The spending plan will then go to the full board next month for ratification.
More details of the budget can be found on the agenda for the meeting. The session will be aired over the Internet. The public can listen in and ask questions online as well. Instructions for participating can be found on the agenda.
Monday, May 06, 2019
Stem Cell Scrutiny in the Golden State: California's Research Program Looks to Avoid Extinction
In just nine days, the California stem cell agency will take a close look at its future, examining its budget for the coming fiscal year as well as the possibilities for a ballot initiative in 2020 that could stave off its financial demise.
The $3 billion enterprise, known formally as the California Institute for Regenerative Medicine (CIRM), expects to run out cash for new research awards this year, perhaps as early as September.
It has sufficient funds to administer its remaining 211 ongoing awards and keep the lights on. But it has only $114 million left before its research coffers are empty.
CIRM is attempting, however, to raise privately $220 million to bridge the gap in research funding between this year and late 2020. The success of that effort is still unknown.
CIRM was created in 2004 by Proposition 71, a ballot initiative that also financed the agency with California state bonds (borrowed money). Since then it has awarded $2.6 billion for stem cell research, including involvement in 53 clinical trials, which are the last stage prior to federal approval of a treatment for widespread use.
Despite the rosy expectations of 2004 campaign, CIRM has not yet backed research that has led to a stem cell therapy that is widely available for public use.
CIRM has scheduled two significant meetings for Wednesday May 15. One involves the agency's budget for the fiscal year that begins July 1. The other involves "discussion of ideas for (a) new initiative."
For readers unfamiliar with the initiative process in California, it is a method for placing before voters proposals for new state laws and funding and basically bypasses the legislature. To qualify a measure for the ballot in the fall of 2020, stem cell research supporters will need to gather hundreds of thousands of valid signatures of registered voters. Usually that is done by hiring firms that specialize in that sort of collection.
Current estimates of the cost of each signature run around $6.00. Estimates of the total cost of a ballot campaign for a new stem cell initiative run in the neighborhood of $50 million, which would have to be raised privately by supporters of the research -- not the agency.
The $3 billion enterprise, known formally as the California Institute for Regenerative Medicine (CIRM), expects to run out cash for new research awards this year, perhaps as early as September.
It has sufficient funds to administer its remaining 211 ongoing awards and keep the lights on. But it has only $114 million left before its research coffers are empty.
CIRM is attempting, however, to raise privately $220 million to bridge the gap in research funding between this year and late 2020. The success of that effort is still unknown.
CIRM was created in 2004 by Proposition 71, a ballot initiative that also financed the agency with California state bonds (borrowed money). Since then it has awarded $2.6 billion for stem cell research, including involvement in 53 clinical trials, which are the last stage prior to federal approval of a treatment for widespread use.
Despite the rosy expectations of 2004 campaign, CIRM has not yet backed research that has led to a stem cell therapy that is widely available for public use.
CIRM has scheduled two significant meetings for Wednesday May 15. One involves the agency's budget for the fiscal year that begins July 1. The other involves "discussion of ideas for (a) new initiative."
For readers unfamiliar with the initiative process in California, it is a method for placing before voters proposals for new state laws and funding and basically bypasses the legislature. To qualify a measure for the ballot in the fall of 2020, stem cell research supporters will need to gather hundreds of thousands of valid signatures of registered voters. Usually that is done by hiring firms that specialize in that sort of collection.
Current estimates of the cost of each signature run around $6.00. Estimates of the total cost of a ballot campaign for a new stem cell initiative run in the neighborhood of $50 million, which would have to be raised privately by supporters of the research -- not the agency.
CIRM is stepping cautiously into the ballot initiative process because of legal constraints. Scott Tocher, CIRM's general counsel, said in a statement to the California Stem Cell Report,
"While a public agency is not permitted to advocate for or against a ballot measure because it is barred from using public funds in an effort to convince the voters with respect to a particular policy position, a public agency may conduct research and draft a ballot measure because these activities are not aimed at persuading voters.
"For instance, the (California) attorney general has concluded that public agencies may engage in outreach to obtain input and assess the feasibility of a measure. In our case, of course, we don’t even have a ballot measure on the ballot yet. The purpose of the meeting is to discuss elements that a future measure might contain, not to campaign for a measure’s passage."
The agency has not yet disclosed its proposed operational budget for the fiscal year that begins July 1. But CIRM is limited by the ballot initiative that created the agency to spending no more than 6 percent of the total it has awarded. This year's operational budget approached $17 million. The spending plan for the next fiscal year is expected to be less.
In the next few days, the California Stem Cell Report will carry more on the upcoming CIRM meetings, including the perspective from Robert Klein, who headed the 2004 ballotcampaign. Klein was also the first chairman of the agency and is eager to see it funded anew with as much as $5 billion.
Thursday, May 02, 2019
New Effort to Require California Medical Board to Act on Snake Oil Stem Cell Clinics
A California measure aimed at regulating "snake oil," stem cell clinics sometime next year has taken a major turn as it wends its way through the legislative process in Sacramento.
The bill, AB617, was amended this week to require California's Medical Board to move on the clinics, which have proliferated across the country in recent years. California has more than 100, according to the latest estimates. An earlier version of the measure placed responsibility with the state Department of Public Health.
The clinics charge thousands of dollars for treatments using substances that they describe as stem cells. However, in virtually all cases, the treatments have not been tested scientifically. Some have led to serious injuries.
According to the latest version of the measure, the state Medical board would be required to create a stem cell advisory group by February 2020 that would make recommendations by July 2020 for regulation of the dubious clinics.
The group could also recommend emergency regulations that could be adopted by the state Medical Board with a 90 day notice.
The new group would have nine members. Three would be appointed by the California stem cell agency, three by state Medical Board, two by the state osteopathic medical board and one by the state nursing board.
The changes in the bill mean that it will require a 70 percent vote by both houses of the legislature. The previous version would have required only a majority vote. The increase is dictated by the fact that it changes Proposition 71 of 2004, which created the state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM).
A spokesman for CIRM said today,
(Following the posting of this item, Mullin released a statement that said:
The bill, AB617, was amended this week to require California's Medical Board to move on the clinics, which have proliferated across the country in recent years. California has more than 100, according to the latest estimates. An earlier version of the measure placed responsibility with the state Department of Public Health.
The clinics charge thousands of dollars for treatments using substances that they describe as stem cells. However, in virtually all cases, the treatments have not been tested scientifically. Some have led to serious injuries.
According to the latest version of the measure, the state Medical board would be required to create a stem cell advisory group by February 2020 that would make recommendations by July 2020 for regulation of the dubious clinics.
The group could also recommend emergency regulations that could be adopted by the state Medical Board with a 90 day notice.
The new group would have nine members. Three would be appointed by the California stem cell agency, three by state Medical Board, two by the state osteopathic medical board and one by the state nursing board.
The changes in the bill mean that it will require a 70 percent vote by both houses of the legislature. The previous version would have required only a majority vote. The increase is dictated by the fact that it changes Proposition 71 of 2004, which created the state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM).
A spokesman for CIRM said today,
"CIRM is working with legislators to help them pass a bill that will regulate clinics offering unproven and unapproved stem cell therapies."
The California Stem Cell Report has asked Mullin's office for comment on the rationale for the latest amendments. We will carry his comments verbatim when they are received.
(Following the posting of this item, Mullin released a statement that said:
(“An important part of the legislative process is working with stakeholders to make sure legislation is as effective as it can be. Our amendments to move the requirements of AB 617 to the California Medical Board's jurisdiction will have a positive outcome. I look forward to continuing to work with MBC, CDPH, CIRM and others to address the serious issues related to potentially fraudulent stem cell clinics.")
The bill has cleared its first Assembly committee and is now before the Assembly Appropriations Committee.
(An early version of this item said that a staff analysis of the bill said it was supported by CIRM. That phrasing was replaced in this version by the quote from CIRM.)
(An early version of this item said that a staff analysis of the bill said it was supported by CIRM. That phrasing was replaced in this version by the quote from CIRM.)
Wednesday, April 24, 2019
California's Intial Moves on Regulation of Dubious, Unregulated Stem Cell Clinics
Legislation targeting unregulated,"snake-oil," stem cell clinics easily cleared its first hurdle yesterday and was put on track for speedy approval by the California legislature.
The measure was amended by its author, Assemblyman Kevin Mullin, D-San Mateo, to set deadlines for moving forward next year with new regulation of the clinics, which have proliferated in California and elsewhere.
The proposal is supported by the state's $3 billion stem cell agency. Jonathan Thomas, chairman of the agency, has called the treatments "snake oil."
The clinics peddle ostensible stem cell therapies for which they charge thousands of dollars. The treatments are not approved by the federal Food and Drug Administration. Some have resulted in injury, including blindness.
An analysis of the measure (AB617) by legislative staff said,
The 2020 deadlines were added to the bill on Monday. However, it is unlikely to mean creation of emergency regulations any sooner than the middle of next year, given state's normal processes.
Mullin's bill won unanimous approval yesterday and was sent to the Assembly Appropriations Committee and was recommended for the consent calendar, which means that it will receive routine approval unless other issues come up. The bill also requires full Assembly and Senate approval and a signature from the governor.
The measure was amended by its author, Assemblyman Kevin Mullin, D-San Mateo, to set deadlines for moving forward next year with new regulation of the clinics, which have proliferated in California and elsewhere.
The proposal is supported by the state's $3 billion stem cell agency. Jonathan Thomas, chairman of the agency, has called the treatments "snake oil."
The clinics peddle ostensible stem cell therapies for which they charge thousands of dollars. The treatments are not approved by the federal Food and Drug Administration. Some have resulted in injury, including blindness.
An analysis of the measure (AB617) by legislative staff said,
"According to the Centers for Disease Control and Prevention in the past year, at least 17 individuals across five states were hospitalized after being injected with therapeutic products made from umbilical cord blood. These particular illnesses have been identified as bacterial infections that have caused swollen spinal disc, infected bones and joints, and abscesses on their backs. Of the 17 infections, 15 have been linked to a single California based company that sells vials of a solution containing umbilical cord blood that they market to ‘stimulate regenerative healing.'"Mullin's bill would charge the state Department of Public Health with creating a body by February 2020 that could enact "emergency" regulations, with 90-day notice, to deal with clinics not in compliance with federal regulations. The panel would also be charged with making recommendations to the legislature by July of next year for new laws concerning the clinics.
The 2020 deadlines were added to the bill on Monday. However, it is unlikely to mean creation of emergency regulations any sooner than the middle of next year, given state's normal processes.
Mullin's bill won unanimous approval yesterday and was sent to the Assembly Appropriations Committee and was recommended for the consent calendar, which means that it will receive routine approval unless other issues come up. The bill also requires full Assembly and Senate approval and a signature from the governor.
Tuesday, April 16, 2019
Stanford Exonerates Researchers Who Had Ties to Scientist in Gene-edited Babies Experiment
Stanford University this afternoon cleared three professors of any wrongdoing in connection with their ties to a Chinese scientist who said his research had led to the world's first gene-edited babies.
Pam Belluck of the New York Times broke the story after obtaining a letter that cleared scientist Stephen Quake in connection with the research, which stirred a global controversy.
Pam Belluck of the New York Times broke the story after obtaining a letter that cleared scientist Stephen Quake in connection with the research, which stirred a global controversy.
Belluck wrote,
“'In evaluating evidence and witness statements, we found that Quake observed proper scientific protocol,' said a letter from the university to Dr. Quake, obtained by The New York Times on Tuesday.
"Referring to the Chinese scientist, He Jiankui, by his nickname, JK, the letter said that Stanford’s investigators concluded that Dr. Quake did not 'directly participate in any way in JK’s research, including in the conception or performance of the work.'
"In fact, the letter said, Dr. Quake discouraged Dr. He from pursuing the project and urged him to follow proper scientific practices after he insisted on going ahead."The Times ran a front page story on Sunday focusing on Quake's email communications with He. Belluck wrote today,
"On Tuesday, Dr. Quake, who turned 50 this week, said: 'I’m pleased this inquiry is over and its conclusion is consistent with what I knew to be true: that I had urged Dr. He not to pursue this path and when it became clear he wouldn’t listen to me, to adhere to high scientific and ethical standards in his research.'"Quake is involved in a $40 million program financed by the $3 billion California stem cell agency.
The other two researchers are Matthew Porteus, a genetics researcher, and William Hurlbut, an ethicist.
As of this afternoon, the Times story on Sunday had generated 329 comments in the Times from readers, covering the full gamut of reaction.
One reader, only identified as JHP, had only this to say,
Another reader, Robert Speth of Fort Lauderdale, said,
The Times also makes its own judgment about comments and labels some as a "Times Pick," It also has a category called "Reader Picks" in addition to "All." The Times moderates its comments for civility.
The reader comments can be found by going to the story and clicking on a small box to the right of the reporter's byline.
As of this afternoon, the Times story on Sunday had generated 329 comments in the Times from readers, covering the full gamut of reaction.
One reader, only identified as JHP, had only this to say,
"For such an intelligent and accomplished person, Dr. Quake comes across as breathtakingly obtuse."The Times said 134 readers "recommended" the remark.
Another reader, Robert Speth of Fort Lauderdale, said,
"Dr. Quake’s actions appear to be that of a dedicated mentor who encourages their students to be successful, but to do so while conducting themselves in an ethical manner. While the investigation by Stanford is warranted, from the information presented in this article, I cannot see even a hint of misconduct by Dr. Quake."The Times said 175 readers "recommended" the remark.
The Times also makes its own judgment about comments and labels some as a "Times Pick," It also has a category called "Reader Picks" in addition to "All." The Times moderates its comments for civility.
The reader comments can be found by going to the story and clicking on a small box to the right of the reporter's byline.
Going Slow in California on Stem Cell "Snake Oil"
California Attorney General Xavier Becerra is remaining mum on regulation of "snake oil," stem cell clinics as the Golden State pursues a go-slow approach to cracking down on the dubious treatments.
More than 100 such clinics are operating in California, the most of any state in the nation. New York state earlier this month took the lead among states in attempting to regulate the clinics, which the chairman of California's $3 billion stem cell agency, Jonathan Thomas, has described as peddling "snake oil."
New York Attorney General Letitia James filed a lawsuit earlier
this month charging that the treatments at one clinic amounted to fraud. She said in a news release,
In the wake of the New York action, the California Stem Cell Report, on April 5 and again on April 11, queried the California attorney general's office about his position on the dubious clinics. However, Becerra's office has failed to respond.
The web site of the state Department of Justice, which is headed by Becerra, says, however,
More than 100 such clinics are operating in California, the most of any state in the nation. New York state earlier this month took the lead among states in attempting to regulate the clinics, which the chairman of California's $3 billion stem cell agency, Jonathan Thomas, has described as peddling "snake oil."
New York Attorney General Letitia James filed a lawsuit earlier
 |
| Letitia James NY Department of Justice photo |
“Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful, and immoral.
“We will continue to investigate these types of clinics that shamelessly add to the suffering of these consumers by charging them thousands of dollars for treatments that they know are unproven.”
The businesses number more than 700 nationwide and have treated an estimated 20,000 persons. The clinics sell products that they say are stem cells for use as treatments for problems ranging from erectile dysfunction to cancer. The treatments lack rigorous scientific testing and cost thousands of dollars. In some cases in Florida, they have resulted in blindness. Other serious injuries have been reported elsewhere.
In the wake of the New York action, the California Stem Cell Report, on April 5 and again on April 11, queried the California attorney general's office about his position on the dubious clinics. However, Becerra's office has failed to respond.
The web site of the state Department of Justice, which is headed by Becerra, says, however,
"The Department of Justice will put patients first in a more quality health care system. We achieve this by protecting patients from bad actors...."Other California state entities have expressed concern about the unregulated clinics but also offer only a slow schedule for action, if any.
Six months ago, the state Medical Board, which regulates physicians, created a task force to look into problem. Asked recently about the task force's progress since October, Carlos Villatoro, spokesman for the board, responded briefly,
The legislation (AB617) is scheduled to receive its first hearing in the Assembly Health Committee April 23.
The unregulated stem cell clinics have been in business for years. Their dubious treatments and sales pitches have been well documented. UC Davis stem cell scientist Paul Knoepfler has been particularly active. He and Leigh Turner of the University of Minnesota were the first to document the full scope of the clinics in a groundbreaking study in 2016.
In recent years, the Food and Drug Administration (FDA) has become more active. In the case of one California firm, Cell Surgical Network, which has been in business since 2010, the FDA sued the firm last May alleging that it had, among other things, used a smallpox vaccine to create an unapproved stem cell product. The product was injected directly into tumors in persons with potentially compromised immune systems, the FDA said.
"The board is gathering information for the Stem Cell and Regenerative Therapy Task Force and has set a goal to have its first meeting in late May, early June."In the legislature, Assemblyman Kevin Mullin, D-San Mateo, has introduced a measure to deal with the clinics. His bill, if it is passed and signed into law, would not take effect until next January. It would direct the state Department of Public Health to hold hearings sometime next next year in order to craft possible legislation to directly regulate the clinics.
A new regulatory panel called the Stem Cell Clinic Regulation Advisory Group would be created. After members are named and organized, it would have the ability to enact "emergency" regulations on a 90-day notice after it has consulted with "the medical community, bioethicists, legal scholars, and patient advocacy groups."
The legislation (AB617) is scheduled to receive its first hearing in the Assembly Health Committee April 23.
The unregulated stem cell clinics have been in business for years. Their dubious treatments and sales pitches have been well documented. UC Davis stem cell scientist Paul Knoepfler has been particularly active. He and Leigh Turner of the University of Minnesota were the first to document the full scope of the clinics in a groundbreaking study in 2016.
In recent years, the Food and Drug Administration (FDA) has become more active. In the case of one California firm, Cell Surgical Network, which has been in business since 2010, the FDA sued the firm last May alleging that it had, among other things, used a smallpox vaccine to create an unapproved stem cell product. The product was injected directly into tumors in persons with potentially compromised immune systems, the FDA said.
Sunday, April 14, 2019
The NY Times Details Stanford Scientist's Communications in the Gene-Edited Babies Controversy
The New York Times this morning carried a front page story dealing with Stanford University, scientist Stephen Quake and gene-edited babies in China.
The story appears to the first time that Quake, who is the Lee Otterson professor of bioengineering and professor of applied physics at Stanford as well as co-president of the Chan Zuckerberg Biohub, has spoken at length publicly about his role in the matter of the Chinese children, who are the first gene-edited babies to be born.
Their announcement last fall created an international brouhaha about the ethics and science of the work by He Jiankui, who once worked in Quake's Stanford lab.
Times reporter Pam Belluck began her story like this
In the Times article, Quake, who is participating in a $40 million genomics program backed by the $3 billion California stem cell agency, denied the allegations. Quake said his interactions with He have been misinterpreted.
The Times wrote,
 |
| Stephen Quake Chan Zuckerberg Biohub photo |
Their announcement last fall created an international brouhaha about the ethics and science of the work by He Jiankui, who once worked in Quake's Stanford lab.
Times reporter Pam Belluck began her story like this
"'Success!' read the subject line of the email. The text, in imperfect English, began: “Good News! The women is pregnant, the genome editing success!'Stanford is investigating Quake's ties and communication with He. The Times reported that the school has received a complaint from the president of He's Chinese university, alleging that Quake “violated the internationally recognized academic ethics and codes of conduct, and must be condemned.”
"The sender was He Jiankui, an ambitious, young Chinese scientist. The recipient was his former academic adviser, Stephen Quake, a star Stanford bioengineer and inventor.
"'Wow, that’s quite an achievement!' Dr. Quake wrote back. 'Hopefully she will carry to term...'"
In the Times article, Quake, who is participating in a $40 million genomics program backed by the $3 billion California stem cell agency, denied the allegations. Quake said his interactions with He have been misinterpreted.
The Times wrote,
"'I had nothing to do with this, and I wasn’t involved,' Dr. Quake said. 'I hold myself to high ethical standards.'
"Dr. Quake showed The Times what he said were the last few years of his email communication with Dr. He. The correspondence provides a revealing window into the informal way researchers navigate a fast-moving, ethically controversial field."
Friday, April 05, 2019
Crackdown on Stem Cell Snake Oil: California's Approach vs. New York's
An attempt in the California legislature to take limited and preliminary action to regulate "snake oil" stem cell clinics stands in sharp contrast to this week's legal action by New York state's attorney general.
California's Assembly Health Committee has scheduled an April 23 hearing on the bill (AB617) by Assemblyman Kevin Mullin, D-San Mateo. Supported by the $3 billion state stem cell agency, it would require the state Department of Health to look into the dubious clinics next year and make recommendations to the legislature.
The legislative hearing comes as New York state attorney general Letitia James announced a lawsuit yesterday against a New York business that has performed what she said are unproven and rogue procedures on patients.
The enterprise is called Park Avenue Stem Cell. A New York Times article by Reed Abelson said,
California has the largest number of the clinics, more than 100, according to a 2016 study and its authors. The New York Times said the businesses "offer people treatments that cost thousands of dollars, which patients typically pay out of pocket because health insurers refuse to cover the therapies. Some products have proved dangerous to patients, blinding some and causing severe infections in at least a dozen people."
UC Davis stem cell researcher Paul Knoepfler and Leigh Turner of the University of Minnesota were the first in the nation in 2016 to document the full scope of what the chairman of the state stem cell agency, Jonathan Thomas, has dubbed a "snake oil" industry.
Regarding the New York lawsuit, Knoepfler was quoted by the Washington Post as saying,
California's Assembly Health Committee has scheduled an April 23 hearing on the bill (AB617) by Assemblyman Kevin Mullin, D-San Mateo. Supported by the $3 billion state stem cell agency, it would require the state Department of Health to look into the dubious clinics next year and make recommendations to the legislature.
The legislative hearing comes as New York state attorney general Letitia James announced a lawsuit yesterday against a New York business that has performed what she said are unproven and rogue procedures on patients.
The enterprise is called Park Avenue Stem Cell. A New York Times article by Reed Abelson said,
"According to (New York) state regulators, Park Avenue Stem Cell also had ties to a California business, Cell Surgical Network, with roughly 100 affiliates around the country, that was sued by the F.D.A. (the Food and Drug Administration) last year. The federal agency is seeking a permanent injunction against Cell Surgical Network...."California is taking a slower and more limited path than New York. Mullin's legislation would do little to halt activity by the clinics this year. California's attorney general, Xavier Beccera, has not spoken out publicly on the issue. The state medical board has created a task force to look into the problem but it is unclear whether it has made any headway.
California has the largest number of the clinics, more than 100, according to a 2016 study and its authors. The New York Times said the businesses "offer people treatments that cost thousands of dollars, which patients typically pay out of pocket because health insurers refuse to cover the therapies. Some products have proved dangerous to patients, blinding some and causing severe infections in at least a dozen people."
UC Davis stem cell researcher Paul Knoepfler and Leigh Turner of the University of Minnesota were the first in the nation in 2016 to document the full scope of what the chairman of the state stem cell agency, Jonathan Thomas, has dubbed a "snake oil" industry.
Regarding the New York lawsuit, Knoepfler was quoted by the Washington Post as saying,
"The unmistakable message is that the firms' time to come into compliance is rapidly running out."
Wednesday, April 03, 2019
"Natural Killer" Cells Score Points for $10.6 Million California Stem Cell Investment
This item has been removed because of inaccuracies in its reporting. The information in the item is under review.
Monday, April 01, 2019
The Quest for Stem Cell 'Franchise Players:' California's $47 Million Recruitment Program
Robert Weschler-Reya briefly discusses some of the implications of his research.
Nine years ago this month, the California stem cell agency kicked off a $47 million recruiting effort to lure star stem cell scientists to the Golden State in what was then an even more fledgling field than it is today.
The first recipient was Robert Weschler-Reya, who left Duke University to join the Sanford Burnham Prebys Medical Discovery Institute in La Jolla, Ca. Weschler-Reya surfaced again last week in an item on the stem cell agency's blog, The Stem Cellar, which discussed the research that he hopes will help children with a deadly brain cancer.
Back in April 2010, directors of the state's $3 billion stem cell agency awarded nearly $6 million to Weschler-Reya. But it took him months to make the decision to come to California. (For more on the process see here and here.)
Ultimately, the agency helped to bring eight other scientists to California through the recruitment effort. All of the awards in the program benefited institutions with past or present representation on the agency's governing board. Those directors could not vote on specific grants to their institutions, but they all voted in favor of creating the recruitment effort.
The overall approach was approved in 2009 by directors of the agency, known formally as the California Institute for Regenerative Medicine (CIRM). Backers said it would lure "paradigm-shifting," "franchise players" to the state.
CIRM Director William Brody, then head of the Salk Institute in La Jolla but also a former president of John Hopkins University in Maryland, said that when California voters created the stem cell agency in 2004,
"I was sitting in Baltimore (and) the big concern was that there would be this big sucking sound for the senior people. And that, by and large, I don't think has happened because there's not been an appropriate mechanism to bring them, and I think this would do that."
As for Weschler-Reya, CIRM quoted him on its blog last week as saying that his research has developed "a valuable tool that will increase our understanding of the biology of the cancer and allow us to identify and test novel approaches to therapy. This advance brings us one step closer to a future where every child survives—and thrives—after diagnosis with CPC (choroid plexus carcinoma).
In his year-seven report on his CIRM research, Weschler-Reya said,
In his year-seven report on his CIRM research, Weschler-Reya said,
"The goal of our studies has been to elucidate the role of stem cells in development, regeneration and tumorigenesis in the cerebellum. We have made significant progress towards this goal during the course of our work.
"Our studies have provided insight into the types of cells derived from cerebellar stem cells during development, and shown that cerebellar stem cells can serve as cells of origin for pediatric brain tumors. Moreover, we developed several new stem cell-based animal models of pediatric brain tumors, and used them to study mechanisms driving tumorigenesis and metastasis. Importantly, we also used these models to screen for compounds that might be effective inhibitors of tumor growth, and identified a number of promising candidates.
"Our long-term goal is to move these agents toward clinical trials, to improve outcomes for pediatric brain tumor patients."Here is a list of all the recipients in CIRM's recruitment program.
Friday, March 29, 2019
Backed by California Stem Cell Agency: $5 Million Measure for Spinal Cord Research Advances in Sacramento
Legislation supported by stem cell research advocates to provide $5 million for work on spinal cord injuries easily cleared its first hurdle this week in Sacramento.
On a 15-0 vote, the proposal, AB 214, was approved Tuesday by the Assembly Health Committee and sent to the Appropriations Committee for placement on the "consent calendar." Such a move could speed action on the bill.
Assemblyman Kevin Mullin, D-San Mateo, authored the bill, which is backed by Americans for Cures, the Palo Alto stem cell advocacy group created by Bob Klein, the first chairman of the $3 billion California stem cell agency.
The agency, known formally as the California Institute for Regenerative Medicine (CIRM), is also listed as a supporter of the legislation. Other supporters included Aivita Biomedical of Irvine, Ca, the California Life Sciences Association and the Miami Project to Cure Paralysis.
The CEO of Aivita is Hans Keirstead, a stem cell researcher formerly with UC Irvine.
No opposition was listed in the legislative staff analysis of the bill.
The measure provides $5 million to support the Roman Reed Act of 1999, named after a man who was paralyzed as the result of a spinal cord injury. Roman and his father, Don Reed, are long-time backers of the stem cell agency's work. The elder Reed is a vice president of Americans for Cures.
The legislative analysis carried this comment sourced to the bill's author:
On a 15-0 vote, the proposal, AB 214, was approved Tuesday by the Assembly Health Committee and sent to the Appropriations Committee for placement on the "consent calendar." Such a move could speed action on the bill.
Assemblyman Kevin Mullin, D-San Mateo, authored the bill, which is backed by Americans for Cures, the Palo Alto stem cell advocacy group created by Bob Klein, the first chairman of the $3 billion California stem cell agency.
The agency, known formally as the California Institute for Regenerative Medicine (CIRM), is also listed as a supporter of the legislation. Other supporters included Aivita Biomedical of Irvine, Ca, the California Life Sciences Association and the Miami Project to Cure Paralysis.
The CEO of Aivita is Hans Keirstead, a stem cell researcher formerly with UC Irvine.
No opposition was listed in the legislative staff analysis of the bill.
The measure provides $5 million to support the Roman Reed Act of 1999, named after a man who was paralyzed as the result of a spinal cord injury. Roman and his father, Don Reed, are long-time backers of the stem cell agency's work. The elder Reed is a vice president of Americans for Cures.
The legislative analysis carried this comment sourced to the bill's author:
"The previous allocations of approximately $15 million in state funding to the Roman Reed program was leveraged over five times that amount in new grants benefiting spinal cord research all across the state. It’s time to reinstate a modest amount of state funding so these efforts can continue."
Sunday, March 24, 2019
California Legislation Targets Unregulated "Stem Cell" Clinics but Not Until Next Year
Legislation that may lead to regulation of dubious stem cell clinics is now before California lawmakers, but it is not likely to result in action until sometime next year at the earliest.
Assemblyman Kevin Mullin, D-San Mateo, announced the measure (AB617) last week. He said in a news release,
Jonathan Thomas, chairman of the $3 billion California stem cell agency, told its governing board last week that the clinics were peddling "snake oil."
Mullin's bill would create an advisory board within the state Department of Public Health to study the problems involving unregulated stem cell clinics and make recommendations to the legislature.
The panel would also have the power to enact emergency regulations. If passed by the legislature this year, it would not take effect until next January. In addition to requiring hearings, the board could not implement emergency regulations without at least a 90-day waiting period.
Asked for comment on the legislation, Art Torres, vice chairman of the state stem cell agency and a former state lawmaker, told the California Stem Cell Report that he would withhold remarks on the bill until "we work out final language/amendments before its first hearing in April."
Generally, proposed laws, including Mullin's measure, do not take effect until January of the following year after they are approved by both houses of the legislature and signed by the governor.
Legislation that has "urgency" status can go into effect immediately, but such measures require a two-thirds vote of both houses instead of a simple majority. Securing a two-thirds vote can sometimes be difficult.
The problems surrounding unregulated clinics have existed for years, but received little attention at the state or federal level until UC Davis researcher Paul Knoepfler and Leigh Turner of the University of Minnesota documented the scope of the business in 2016.
California's state medical board, which regulates physicians, is also looking into the unregulated clinics.
Assemblyman Kevin Mullin, D-San Mateo, announced the measure (AB617) last week. He said in a news release,
More than 100 unregulated "stem cell" clinics exist in California and hundreds more throughout the nation. They use what they describe as stem cells in untested treatments that cost thousands of dollars. A number of injuries, including blindness, have been reported. (See here, here, here and here.)“It is clear that more must be done to ensure the proper regulation of for-profit stem cell clinics."
Kevin Mullin, LA Times photo
Jonathan Thomas, chairman of the $3 billion California stem cell agency, told its governing board last week that the clinics were peddling "snake oil."
Mullin's bill would create an advisory board within the state Department of Public Health to study the problems involving unregulated stem cell clinics and make recommendations to the legislature.
The panel would also have the power to enact emergency regulations. If passed by the legislature this year, it would not take effect until next January. In addition to requiring hearings, the board could not implement emergency regulations without at least a 90-day waiting period.
 |
| Art Torres |
Asked for comment on the legislation, Art Torres, vice chairman of the state stem cell agency and a former state lawmaker, told the California Stem Cell Report that he would withhold remarks on the bill until "we work out final language/amendments before its first hearing in April."
Generally, proposed laws, including Mullin's measure, do not take effect until January of the following year after they are approved by both houses of the legislature and signed by the governor.
Legislation that has "urgency" status can go into effect immediately, but such measures require a two-thirds vote of both houses instead of a simple majority. Securing a two-thirds vote can sometimes be difficult.
The problems surrounding unregulated clinics have existed for years, but received little attention at the state or federal level until UC Davis researcher Paul Knoepfler and Leigh Turner of the University of Minnesota documented the scope of the business in 2016.
California's state medical board, which regulates physicians, is also looking into the unregulated clinics.
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