California's Go-Slow Action on Rogue Stem Cell Clinics: No Regulation or Legislation in Sight

In 2016, the scope of  clinics selling unproven stem cell
treatments was first documented. This 2016 map shows their
 spread.  Since then the number is estimated to have grown
 from about 600 to more than 1,000.

Californians should not count -- any time soon -- on a state crackdown on rogue "stem cell" clinics that peddle treatments that have harmed desperate people and cost them many thousands of dollars.

The state Medical Board, which regulates physicians, last week told the California Stem Cell Report that its response to the clinics will be limited to "guidelines," which have not yet been drafted. The guidelines, if eventually approved, would not have the power of legal regulations. (See the board's full statement at the end of this item.) 

More than 1,000 clinics are estimated to be operating in the United States with the highest percentage of them in California.  Injuries involving fecal contamination and deaths have been reported. At least 20,000 persons are estimated to have been treated.

Nearly two years ago, the Medical Board first took up the issue and created a two-person "task force" to look into possible regulation. State legislation aimed at establishing regulations died quietly last year.  

The Medical Board's update on its activities came as officials of the state's stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM), called for stepped-up action against what some describe as  "snake oil" peddlers. 

The agency's appeal came in an article this month in the scientific journal Stem Cells Translational Medicine. Authored by Geoffrey Lomax, CIRM's senior officer for therapeutics, strategic infrastructure and public policy; Art Torres, vice chairman of the agency's board, and Maria Millan, president of the agency, the article cited reports of injuries and deaths caused by treatments "often administered by clinicians practicing outside their medical training." 

The trio called for "regulated, reliable and reputable" standards for stem cell treatment in California as well as nationally. The Food and Drug Administration (FDA), however, has been attempting for a number of years to deal with the problem with mixed success. In a warning to consumers, it said, 

"(D)on’t believe the hype. Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures—and confirm what’s really being offered before you consider any treatment."

Currently persons seeking the unproven treatments have no legal assurance that they are actually receiving stem cells. 

Not all states are as passive as California in regulation of the clinics and employees. Last month, the Minneapolis Star Tribune reported that the Minnesota State Medical Practice Board disciplined a physician for making claims that haven't been proven in medical research. 

Last April, the state of New York sued one clinic, declaring that the rogue clinics "shamelessly add to the suffering of these consumers by charging them thousands of dollars for treatments that they know are ineffective.”

The clinics operated generally unnoticed until Paul Knoepfler, a UC Davis stem cell researcher, and Leigh Turner, a bioethicist at the University of Minnesota, published an article in 2016 a scientific journal that laid out the size of the business. 

The two have also noted the too-good-to-be-true pitches of the clinics. The officials of the California stem cell agency cited the case of a single product that was purported to treat  "Parkinson's disease, multiple sclerosis, cerebral palsy, macular degeneration, osteoarthritis, strokes, heart attacks, and chronic kidney disease."

Writing earlier this month on his blog, The Niche, Knoepfler said that federal efforts have had some impact on the clinics.  But he said, 

"The bottom line though is that it’s not clear if all these state and federal actions are going to make a meaningful dent in the massive marketing of unproven stem cells in the U.S. Some kind of more assertive action seems necessary by regulators in the most extreme cases where, for example, the product in question is clearly a drug and has harmed patients."

California stem cell officials said, 

"(I)t is vital to  (support) the continued development of promising regenerative medicine products while protecting patients from the risks posed by unproven interventions."

Here is the full text of the statement that the California's Medical Board  made to the California Stem Cell Report:

"The Board is continuing to work toward the goal of providing recommendations on stem cell and regenerative therapies and developing some guidelines that California physicians and patients can follow. Board staff is working on compiling the information discussed at the interested parties meeting into a document to be reviewed by the Task Force.  The Task Force will then work with staff on developing a guidance document for physicians regarding stem cell and regenerative treatment that will include a sample informed consent document and educational materials for the public to present to the Board for review and final approval. The Board does not have a timeline to share at this time."

Federal Stem Cell Regulation Setback in California; Case Involves Treatments with Fat Cells

Dubious stem cell clinics in California were in the news again this week with a piece in the Los Angeles Times declaring that a federal judge had dealt a blow to regulators trying to crack down on the much-criticized enterprises. 

The column by Michael Hiltzik said,

"A Los Angeles federal judge has rejected a government motion that could have shut down a network of clinics offering customers allegedly unauthorized stem cell treatments.

"The ruling by Judge Jesus G. Bernal potentially deals a setback for the Food and Drug Administration’s campaign against treatments using stem cell preparations that the FDA has not approved. 

"In the ruling published late Monday, Bernal denied the government’s motion for summary judgment in its lawsuit against the Rancho Mirage-based California Stem Cell Treatment Center, the Cell Surgical Network, and the latter’s founders, Mark Berman and Elliott Lander. Bernal ruled that the case was suitable for trial."

UC Davis stem cell researcher Paul Knoepfler also wrote about the case on his blog.

"The reasons why Bernal said he rejected the summary judgment request are concerning and don’t fit with my view of the medical science here as a stem cell biologist. 

"Unfortunately, this all leaves the door potentially still open for hundreds of clinics to sell the unproven fat stem cell product at the heart of this case called 'stromal vascular fraction' or (SVF)."

This lawsuit was first filed in May 2018 and is likely to continue for some time, possibly involving lengthy appeals. 

The controversy over unregulated clinics is of concern to those who support refinancing California's stem cell agency with $5.5 billion via a hoped-for voter approval of a ballot measure in November. The fear is that the flap could create voter confusion and besmirch the entire field. 

The agency was created in 2004 by voters who provided it with $3 billion. It is now down to its last $27 million for research grants. That figure is likely to increase next week as agency directors hear a report on the amount of cash recovered from awards that did not meet benchmarks.

California Regulators and Dubious 'Stem Cell' Clinics: Possible New Rules Sometime Next Year

The California state Medical Board is expected to come up with new regulations to deal with rogue "stem cell" clinics sometime next year, the San Francisco Chronicle reported yesterday. 

The rules could require more patient education about the treatments and risks as well as providing more information to physicians about federally permissible treatments. The chairman of the state's $3 billion stem cell agency has described the unproven treatments as "snake oil."

The Chronicle story by Erin Allday emerged from a hearing yesterday by a small panel of the Medical Board. Any proposal for more regulation would have to go to the full board and run through the lengthy state administrative process before taking effect.

UC Davis stem cell scientist Paul Knoepfler, who also testified at the hearing, wrote about the session on his blog. He said that physician and patient education could be "helpful." He added,

"(B)ut I wonder whether the board will actually take more direct action on the few physicians who are arguably running the riskiest clinics here in our state. Such a step would do the most to rein in the problem."

Knoepfler, who has long studied the dubious clinics, described yesterday's hearing as a "positive development." He added, 

"I just don’t know how much concrete action will come out of it and when."

Chronicle reporter Allday wrote,

"The state has come under increasing pressure by stem cell experts to tamp down on the booming consumer industry in recent years, but almost no action has been taken. Wednesday’s meeting in Sacramento, attended by a few dozen scientists, patient advocates and stem cell providers, was largely informational, and medical board representatives repeatedly noted that they have limited authority over the industry.

"But they also acknowledged concerns that 'some providers are deceiving patients and placing them at risk,' said Dr. Randy Hawkins, co-chair of the stem cell task force organized by the California Medical Board."

Also testifying was the president of the state stem cell agency, Maria Millan. Here is a link to an item earlier this week on Millan's presentation.  

Here are links to a presentation by Mehrdad Abedi of UC Davis, a specialist in bone marrow transplantation,  on biologics regulation of stem cells and to a presentation by Charity Dean, assistant director of the State Department of Public Health.

'Regulated, Reputable, Reliable:' A California Call for More Regulation of Dubious 'Stem Cell' Clinics

The president of the $3 billion California stem cell agency, Maria Millan, this week is recommending a new approach to state regulation of rogue "stem cell" clinics that are preying on desperate patients.

In a presentation prepared for a meeting Wednesday of the

Maria Millan
CIRM photo

stem cell task force of the State Medical Board, Millan listed standards for patient care, declaring that the field should be "regulated, reputable and reliable."

Millan said patients are being harmed by unproven treatments at clinics in California and elsewhere. The chairman of the board of her agency, Jonathan Thomas, has called the treatments "snake oil." (The agency is formally known as the California Institute for Regenerative Medicine (CIRM).)

A small task force of the State Board is laying the groundwork for additional regulation of the industry, which has grown rapidly in recent years. Estimates are that 1,000 clinics exist across the country with the largest number in California. 

Earlier this year, a measure to set standards for the clinics died in a legislative committee. The board itself initiated its task force more than a year ago. This week is its first public hearing. 

Millan's slide presentation for the meeting did not go into details. But she called for improved informed consent from patients and raised the following considerations:

• Creation of publicly available registries of stem cell treatment options  
• Creation of a method for patients to self-report outcomes or harm from unregulated regenerative medicine treatments 
• Requiring "clear visibility" for patients of the treatment team's credentials
• Creation of a "mechanism for investigating those holding healthcare  licenses suspected of violating professional        standards when providing unproven stem cell interventions,  particularly those outside their scope  of training" 
• Registration of treatments that involve human cellular and tissue products along with a clear distinction between federallly authorized treatments and practice of medicine

The public can file comments on the matter by emailing them to April.Alameda@mbc.ca.gov.  Check here for details on Internet access to the meeting.

Google to Halt Advertising by Dubious Stem Cell Clinics, Cites 'Bad Actors'

Google says it is cracking down on advertising by rogue "stem cell" clinics, which it characterized as a rising tide of "bad actors" who are fleecing patients yearning for cures. 

The announcement came Friday and was quickly picked up by the Washington Post and then numerous other outlets, ranging from Yahoo to the MIT Technology Review. 

Google's move, which takes effect next month, would seem to add impetus to a growing cry for more and faster regulation of the dubious clinics by state and federal regulators. Both the Food and Drug Administration and California have been slow to act although the problem has been known for years. (See here, here and here.)

Injuries, blindness and deaths have been reported globally as the result of the so-called stem cell treatments. No assurances exist that the substances being used are, in fact, stem cells. 

The MIT article by Antonio Regalado noted that Google hauls in more than $110 billion annually in advertising revenue. The first sentence of his piece said, 

"After brazenly taking ad money from health-care scammers, Google is finally saying no to ads for unproven stem-cell treatments."

A UC Davis researcher, Paul Knoepfler, a national leader and pioneer in documenting the reach of the rogue clinics, said on his blog,

"I see the new policy by Google as a positive step and support them taking it. Perhaps some mainstream media outlets will follow suit and also adopt policies whereby they do not run these risky biomedical ads."

He also noted, 

 "These ads and certain particularly risky clinics also are a real threat to the legitimate stem cell and gene therapy fields."

Deepak Srivastava, president of the International Society for Stem Cell Research and head of the Gladstone Institutes in San Francisco, said in a statement, 

“Google’s new policy banning advertising for speculative medicines is a much-needed and welcome step to curb the marketing of unscrupulous medical products such as unproven stem cell therapies.”

The California State Medical Board has scheduled a Sept. 18 hearing into the clinics with an eye to strengthening regulation of treatments at the clinics. 

California Regulators Fleshing Out Details of Hearing on Regulation of Rogue Stem Cell Clinics

California state regulators have posted the line-up for a meeting later this month to deal with rogue stem cell clinics that peddle "snake oil" treatments that have led to injury and financial loss.

The meeting comes as Google announced this week that it is cracking down on advertising involving the dubious clinics. Also this week, the president of the largest group of stem cell researchers in the the world warned of the dangers of unproven treatments. 

Deepak Srivastava, president of the Goldstone Institutes in San Francisco and leader of the International Society for Stem Cell Research, said the promises of the largely unregulated clinics "aren’t true--they’re propagated by people wanting to make money off of a desperate and unsuspecting or unknowing public."

The state Medical Board scheduled its meeting for Sept. 18 in Sacramento as a precursor to possible regulation of the activities of medical professionals at the clinic.

Scheduled to testify are Maria Millan, president of the $3 billion state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM), and Mehrdad Abedi of UC Davis, a physician, cancer specialist and stem cell researcher. 

Abedi is a key figure in UC Davis' Alpha Clinic, which is designed to coordinate and sharpen the focus of clinical stem cell research and treatment. 

Also scheduled to appear are representatives of the State Department of Public Health. The meeting is scheduled to be available via the Internet. The public can attend and comment at the session. 

The medical board said earlier that another session may be scheduled later this fall. Recommendations for regulations could come to the full medical board in January. See here for more details on the board's plans.

New Warning on Shady Stem Cell Clinics that Prey on Desperate Patients; California Hearing Coming Up

The head of the largest organization of stem cell scientists in the world this week spoke out about rogue stem cell clinics that are fleecing and endangering desperate patients. 

Deepak Srivastava
Gladstone photo

Deepak Srivastava, president of the International Society for Stem Cell Research and president of the Gladstone Institutes in San Francisco, said advertisements and pseudo news articles are promising cures for everything from autism to cerebral palsy.

"The claims simply aren’t true--they’re propagated by people wanting to make money off of a desperate and unsuspecting or unknowing public," Srivastava wrote on the web site of the Scientific American.

The headline on his article said, 

"Don’t Believe Everything You Hear about Stem Cells

"The science is progressing rapidly, but bad actors have co-opted stem cells’ hope and promise by preying on unsuspecting patients and their families"

The piece comes as California is preparing to take another step in regulation of the clinics, which have burgeoned across the nation.  Estimates are that the number of clinics exceeds 1,000 with the California having the largest share. 

The state Medical Board has scheduled a hearing on the clinics Sept. 18. The head of the state's $3 billion stem cell agency, Maria Millan, is slated to testify among others. Members of the public may testify as well. The Sacramento hearing will be broadcast on the Internet. 

(About eight hours after this item was published, the Medical Board board posted its agenda for the meeting.)

UC Davis stem cell scientist Paul Knoepfler and Leigh Turner of the University of Minnesota were the first to chronicle the scope of the dubious clinics. Knoepfler wrote this week about a follow-up study that he has published that showed that regulators have a whack-a-mole problem. 

Knoepfler said that his study "indicates that stem cell clinics are in general a fairly rapidly-changing type of business and many disappear or change over a few years. This makes overseeing this clinic industry harder for (regulators)." 

Both state stem cell agency and the international stem cell  group, which has more than 4,000 members in 60 countries,  provide information aimed at helping patients separate legitimate stem cell activities from bogus ones. Here is a link to the ISSCR advice. Here is a link the state stem cell agency's information. 

'Snake Oil' Stem Cell Clinics Target of California State Regulators Sept. 18

The California State Medical Board said today it will hold a public hearing Sept. 18 to respond to the burgeoning growth in dubious "stem cell" clinics, some of which have reportedly left some patients harmed both physically and financially.

"Snake oil" is what the unregulated clinics are selling, according to Jonathan Thomas, chairman of $3 billion California stem cell agency, which will be invited to appear at the Sacramento meeting next month. 

The clinics have been operating for years nationally, with at least an estimated 1,000 currently in business. California has the largest number. In the past couple of years, the clinics have achieved more notoriety. That includes a "buyer beware" piece this month on HealthDay.

Responding to an inquiry last week by the California Stem Cell Report, Kimberly Kirchmeyer, executive director of the Medical Board, said today in an email that topics likely to be covered at the board's hearing include:

• Best practices guidelines and outreach and education
• Improved informed consent practices
• Adverse event reporting when treatments go wrong
• Other options to be considered by the board

In addition to the stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM), the board said it would invite the state Department of Public Health. Members of the public may appear as well.  The Medical Board is the chief regulatory agency for physicians.

Here is the full text of Kirchmeyer's statement, which includes a timeline on the board's actions related to the dubious clinics:

"At the July 2018 Board Meeting, the Board was provided a policy that was adopted by the Federation of State Medical Boards at their annual meeting.  The policy contained several recommendations for state boards regarding Regenerative and Stem Cell Therapy Practices.

At the October 2018 Board Meeting Ms. (Denise) Pines, (president of the board), established a Board Task Force on Stem Cell and Regenerative Therapy.   In April 2019, Board staff met with the California Department of Public Health to discuss issues regarding stem cell and regenerative therapy and discussed how the two entities could work together.  The two organizations also discussed some of the issues regarding investigating complaints regarding these practices. 

"On June 27, 2019, the Task Force members met with Board staff to discuss oversight options the Board may decide to pursue to protect California consumers from unapproved and potentially dangerous stem cell products and therapies and next steps.  

"A few options discussed included the development of educational materials, exploring outreach opportunities, and developing best practice guidelines similar to those adopted by the Federation.  The Task Force also discussed the need for some type of guidance for informed consent.  While current law requires notice to patients regarding stem cell therapies, it only requires notification to the patient that the therapy is not FDA-approved and encouraging the patient to consult with their primary care physician. 

"The Task Force believes a more in-depth informed consent may be needed.  In addition, discussion also included the need for adverse event reporting and what would be required for such reporting. 

"It was determined that the Task Force hold an interested parties meeting to receive feedback from consumers, experts, and stakeholders to assist in the development of materials, guidelines and/or to determine if there are additional options that should be considered.  At this meeting, the Board is also going to ask for presentations from the California Department of Public Health and the California Institute for Regenerative Medicine.

"The meeting will be held September 18 in the afternoon (at board headquarters in Sacramento).  If necessary, a second interested parties meeting will be held by mid-November.  The Task Force hopes to have recommendations presented to the Board at its January 2020 meeting.  "You will be able to watch the update on the webcast when it is posted on the Board’s website within the next two weeks.  Here is the link to the page where the webcast will be posted: http://www.mbc.ca.gov/About_Us/Meetings/ "

The California Stem Cell Agency: 'Envy of the World, ' Hopes Too High?

The prestigious journal Nature yesterday published a piece about California's $3 billion stem cell agency that spoke of voids, envy and "double-edged swords."

The opinion piece was written by Jeanne Loring, a San Diego area

Jeanne Loring

researcher who has followed the agency for years and has been one of its beneficiaries($17 million in awards).

Reflecting on the agency's importance, she wrote,

"For the past dozen or so years, stem-cell researchers in California have been the envy of the world."

Creation of the agency, known formally as the California Institute for Regenerative Medicine (CIRM), "essentially guaranteed that the state would become the center of innovation in the field," Loring declared. Its demise would leave a major void, she said.

Loring continued,

"Although its intentions were laudable, CIRM raised the hopes of the public too high. It needed catchy advertising to gain voters’ support. One of its campaign slogans was 'Save lives with stem cells.' Effective advertisements often focus on a promise and downplay shortcomings, such as the time and resources required to advance a stem-cell therapy through clinical trials to market approval. No CIRM-supported therapy has been approved by the US Food and Drug Administration (FDA), resulting in dashed expectations.... 

"Still, fulfilment of the campaign promise is under way. CIRM has granted funding for 56 stem-cell-based clinical trials."

At the same time, dubious and unregulated clinics that peddle stem cell "snake oil" have proliferated across the country, leading the FDA to attempt a belated takedown of some of the enterprises.

The growth of those clinics is part of "the double-edged sword that is CIRM’s legacy,"  Loring said.

"The agency has enabled fundamental science and helped to establish know-how for rigorous assessment of stem-cell therapies. Earlier this year, my colleagues and I started a biotechnology company, Aspen Neuroscience in La Jolla, California, and are raising funds for a clinical trial of a neuron-replacement therapy for Parkinson’s disease. Without the work that CIRM has done to educate investors and researchers, this would have been very difficult. 

"But the agency’s work has inadvertently helped to boost unregulated, for-profit ‘clinics’ claiming, without sound evidence, that cells derived from fat, bone marrow, placenta and other tissues can cure any disease."

Loring said,

"CIRM has regularly denounced these clinics, which existed before the institute’s creation and will persist as long as they can make money. Still, it is easy to understand how public enthusiasm would spill over to those offering quackery."

Loring noted that the agency, which expects to run out of cash for new awards this year, is hoping that voters will give provide $5 billion more via a ballot initiative in November 2020. 

Loring urged rhetorical caution in the ballot campaign.

"We must strike a balance between future potential and current reality when we talk to the public. Researchers should emphasize that even when therapies show promise in mice, they often fail to work in humans. The only way to find out — and to check for safety — is rigorous scientific testing in clinical trials."

"We need to temper public hope," Loring wrote, while regulators, including the FDA and the California State Medical Board, bring the bad actors under control. 

Unregulated Stem Cell Treatments Targeted by California Medical Board; Hearing Next Week

"Snake oil" stem cell clinics in California and their physician operators are on the agenda next week of state medical regulators as deep concerns are being raised in Congress about the slow pace of federal action against the enterprises. 

Last week, a bipartisan group of leaders of a U.S. House of Representatives committee told the Food and Drug Administration (FDA) in a letter, 

"We appreciate the actions taken by FDA, but this pattern of unsafe and unproven therapies remains deeply concerning. Such treatments not only pose public health risks for patients, but also harm the future promise held by the development of stem cell therapy as a field."

California also has been slow in dealing with the issue. State legislation to deal with the matter has been shunted aside.  More than a year ago, the state's Medical Board created a task force to deal with the issue. The panel did not hold its first meeting until June 27 of this year and then with no public notice. 

Experts who follow growth of the dubious clinics say more than 1,000 exist in the United States. The largest number are in California. The treatments are unproven and cost desperate patients thousands of dollars. The clinics have been linked with several cases of blindness and at least 12 serious infections. The FDA has filed lawsuits against two, including one in California, and sent 45 letters to clinics involving their practices. 

The agenda for next week's state medical board meeting says only that an "update" will be delivered by the task force which consists of two members of the board, Randy Hawkins and  and Howard Krauss. No action was specifically listed for the agenda item (No. 21), but the board couches its agenda in such fashion that it could legally act on any matter before it. 

The Congressional letter to the FDA not only expressed serious concern about the proliferation of unproven therapies,  but also said, 

"The advertising strategies some of these clinics employ to attract some of the most vulnerable patients are particularly alarming. Some have advertised stem cell treatments to desperate patients with the most serious untreated illnesses, such as spinal injuries, Parkinson's disease, and multiple sclerosis. Some clinics have misled patients into believing that the therapies they offer are FDA approved or that they are being offered as part of an FDA sanctioned clinical trial."

The chairman of the board of California's $3 billion stem cell agency, Jonathan Thomas, has called the treatments "snake oil." The agency, formally known as the California Institute for Regenerative Medicine (CIRM), is running out of cash. It is worried that a move to refinance the agency via a ballot measure next year could be harmed by voter confusion about the stem cell research.

The congressional letter said,

"When providers offer harmful, unproven stem cell therapies outside of the clinical setting, they create confusion among patients and undermine public confidence in treatments that have been proven to be safe and effective through well-designed clinical trials. If we are to realize the potential clinical benefits of stem cell therapies, it is crucial that developers focus their efforts on the use of traditional developmental pathways that yield definitive results rather than promoting products with 'dubious clinical efficacy and possible risks.'"

Next week's meeting is open to the public. Letters to the board can be emailed to executive director, Kimberly Kirchmeyer, at Kimberly.Kirchmeyer@mbc.ca.gov.

UC Researcher on Stem Cells and California's Stem Cell Agency

The California stem cell agency recently highlighted a brief look at the field with a Q&A that ranged from the impact of the agency itself to dealing with questions about "miraculous" stem cell "cures."

The item appeared on the agency's blog and originated at UC Davis, which is among the top five recipients of funds from the agency, known formally as the California Institute for Regenerative Medicine (CIRM).

The school has received $143 million, making it fifth on the list of recipients in terms of dollars.

The Q&A involved Jan Nolta, head of the stem cell program at UC Davis. Some excerpts from what Nolta had to say:

Jan Nolta, UC Davis photo

"Perhaps the most promising and exciting research right now comes from combining blood-forming stem cells with gene therapy. 

"Along with treating the famous bubble baby disease, where I had started my career, this approach looks very promising for sickle cell anemia. We’re hoping to use it to treat several different inherited metabolic diseases.... 

"The beauty of this therapy is that it can work for the lifetime of a patient. All of the blood cells circulating in a person’s system would be repaired. It’s the number one stem cell cure happening right now. Plus, it’s a therapy that won’t be rejected. These are a patient’s own stem cells. It is just one type of stem cell, and the first that’s being commercialized to change cells throughout the body."

About the five Alpha stem cell clinics initiated by CIRM, Nolta said,

"These are clinics where the patients can go for high-quality clinical stem cell trials approved by the FDA [U.S. Food and Drug Administration]. They don’t need to go to 'unapproved clinics'a and spend a lot of money. And they actually shouldn’t."

California Medical Regulators Take Up Dubious Stem Cell Clinics Next Month

The California State Medical Board next month will discuss clinics that offer unregulated "stem cell" treatments that have allegedly led to blindness and tumors in some cases. 

The meeting comes a year after the board created a "task force" to address the issue.  It also comes as more news emerged this month concerning what was described as a "gruesome case" of an unregulated treatment that went wrong and a step-up in legal action against a La Jolla clinic. 

Canada this week also told dozens of clinics to stop selling unproven stem cells.

California is the location of the largest number of these dubious clinics in the United States, according to UC Davis stem cell researcher Paul Knoepfler and Leigh Turner of the University of Minnesota. The total nationally is currently believed to be more than 1,000. 

State legislation to regulate them is on the shelf in Sacramento. The state medical board formed a two-person task force last July to address the matter. The task force only recently held its first meeting on June 27. 

Queried by the California Stem Cell Report about the status of the board's work, Carlos Villatoro, a board spokesman, said this week, 

"There will be an update on the Stem Cell Task Force at the August meeting, as the Task Force has met. In addition, an interested parties meeting is being scheduled for early September."

The task force met with no public notice, which Villatoro said was not legally required. 

Villatoro has said that the board does not regulate clinics -- only physicians and some other medical professionals. The board describes itself as a consumer protection agency. 

(Here are links to what the board describes as a "complete listing" of laws dealing with its regulatory powers: California Law and Guide to the Laws Governing the Practice of Medicine by Physicians and Surgeons.)

The board meeting next month will be in Burlingame Aug. 8 and Aug. 9.  The agenda has not been posted, but the meeting is expected to streamed on the Internet. 

A Stem Cell Crossroads in California: The Viewpoint From USC

The University of Southern California, co-sponsor of a meeting this week in Los Angeles of 4,000 stem cell researchers and others, has offered up a perspective on its program and the crossroads facing California. 

The lengthy piece by Gary Polakovic captured more than the work being done USC, which has received $111 million in funding from the state stem cell agency, formally known as the California Institute for Regenerative Medicine (CIRM). 

He touted the program at USC but also looked at the state of stem cell affairs in the Golden State.  

Keying off the annual meeting of International Society for Stem Cell Research, Polakovic, research communications manager at USC, wrote, 

"California has proven fertile soil for stem cell research. The state has assumed a leadership role in stem cell science since voters approved Proposition 71 in 2004, which seeded the industry with $3 billion in bond funds. The program is administered by CIRM, which contributes about 30 percent of USC stem cell funding."

The article continued, 

"With progress comes growing pains, and California’s stem cell program is at a crossroads.

"On one hand, gains in the lab have moved stem cell therapies closer to making a significant impact on medicine. Yet, the complexity and cost of cellular medicine has proven a big challenge. Scientists acknowledge it will be difficult to cure major diseases with stem cells. The gap between hype and hope has narrowed, but not closed.

"'Hype can be right, but it’s the time frame when people

Andrew McMahon, USC photo 

expect things to happen that can be wrong,' (Andrew) McMahon (director of the USC stem cell program) said. 'Curing cancer, diabetes, Alzheimer’s and other diseases is taking longer and involves a lot more complication and funding. The progress has been astounding — but it’s never fast enough.'"

Polakovic also tackled the difficult financial condition of the state stem cell agency. He wrote, 

"State funding for stem cell research under CIRM is expected to run out this year. The $3 billion ballot initiative that voters approved — Proposition 71, the California Stem Cell Research and Cures Act — is substantially depleted. Other sources, such as federal funding, private investment and philanthropy, are available but not necessarily dedicated to statewide research. CIRM funds have played a big role in creating and sustaining the USC stem cell initiative.

"Researchers are hopeful California voters will have an appetite to continue funding. Backers of Proposition 71 are planning a $5 billion measure for the November 2020 ballot. With research gains and clinical trials underway, backers are hopeful California will continue to support progress for another decade.

"Yet, voter perception of stem cells could be colored by rogue clinics peddling dubious wonder cures like snake oil. Those businesses operate outside the realm of leading research institutions such as USC. More than 100 such stem cell clinics operate in California alone. The Food and Drug Administration is stepping up enforcement actions against clinics offering unapproved stem cell products that endanger the public.

"At the same time, the momentum toward stem cell therapies at USC and other universities is undeniable. On the trail to finding breakthroughs for big diseases, basic research has unlocked a host of co-benefits — many unforeseen when California embarked on its stem cell program 15 years ago — that are valuable to medicine."

Stem Cell Video Flap: A Look at the California Firm Backing the 'Docu-Series'

A California physician deeply enmeshed in the national ruckus over a controversial, stem cell video has -- according to his web site -- "achieved world-renown as a pioneer in the area of stem cell research."

He is Mark Berman, one of the co-founders of Cell Surgical Network (CSN), which partly financed the lengthy, online video, "Healthcare Revolution." At least 12 scientists, other experts and institutions reacted with shock last week when they became fully aware of its approach and financing. They asked that they be removed from the film.

Mark Berman,  photo from Berman web site

One researcher called the video an "infomercial." Another said she was placed with "charlatans and thieves."

Berman's firm has been sued by the Food and Drug Administration as part of an effort to curb untested and potentially dangerous stem cell treatments. The number of dubious stem cell clinics has grown sharply in recent years. Estimates are that 1,000 exist nationally, with the highest percentage in California.

On Sunday he emailed the irate scientists and asked them to reconsider their requests for removal. None apparently did. 

What follows is a brief look at Berman's history and that of his firm, which has offices in Beverly Hills and Rancho Mirage, Ca., and about 100 affiliates nationwide and more abroad. 

But first, the text of his response to questions from the California Stem Cell Report about the video and its financing. The "docu-series" was produced by Bobby and Sara Sheehan and their firm, Working Pictures.

"I met Bobby and Sara when they came to interview me at my office for another project they were working on a couple years ago. We were commenting on all the amazing work being done in the field of cell therapy and stem cell research, yet all the surrounding controversy. A lot of this was due to people putting random unmatched cells into patients for a whole host of conditions and not adequately tracking the follow up. We thought it would be really important to show some of the world’s greatest minds, who have devoted, in some cases, decades to advancing this field, and highlight all the great work that’s currently being done to advance healthcare.

"I’m not sure what the entire series cost. We were just a tiny part of this film. Bobby and Sara spent over a year flying around the world to get this project done. they worked completely independently from us. Neither I, nor anyone in CSN, paid anyone that was interviewed or promised them compensation. We have zero financial interest in Working Pictures, nor do they have any financial interest in CSN. 

"This whole project is about educating people on the work being done to advance healthcare and we think it’s important that the word gets out."

Berman's website says he has practiced cosmetic surgery since 1983 and started his stem cell practice in 2010.  He is co-founder of Cell Surgical Network and the California Stem Cell Treatment Center. 

Erin Allday of the San Francisco Chronicle reported last year: 

"For more than three decades, Berman’s focus was breast augmentations and face-lifts. He invented a pocket-like device that can be implanted into the breast to produce better-looking, safer results from augmentation procedures. He calls it his “Sistine Chapel.”

With his business partner, Rancho Mirage (Riverside County) urologist Elliot Lander, Berman has built the largest chain of stem cell clinics in the country. Their Cell Surgical Network has more than a hundred affiliates in 33 states — including 38 clinics in California alone — selling treatments they claim will fix everything from knee pain to symptoms of multiple sclerosis.But over the past eight years, Berman has reached far past his specialty into a realm of highly sophisticated, still-nascent medicine. He’s become one of the country’s most outspoken and notorious providers of so-called consumer stem cell therapies: using human stem cells to treat a wide variety of ailments despite little or no scientific proof that they work.

“As a cosmetic surgeon, it’s kind of a joke that I’m at the center of this universe,” Berman said in an interview last fall (2017). “But I’m kind of ground zero.”

"Seven months later, his words became darkly prophetic: In May, Berman and his partner were targeted by the U.S. Food and Drug Administration. The FDA requested an injunction that, if approved by a federal judge, would stop them from selling stem cell therapies. 

"The FDA issued a similar request against a separate operation in Florida, U.S. Stem Cell Clinic.

"Their clinics, though, are just some among several hundred that have popped up across the country in recent years. They are renegade outposts operating with little legitimacy and oversight at the frontier of what is otherwise a highly promising field of medicine."

Here is a short list of other sources of information involving Berman, his treatments and  enterprises: 

• Stem cell scientist Paul Knoepfler of UC Davis has written extensively about Berman and Cell Surgical Network, going back to 2013 when Knoepfler published this Q&A.
• Vox recently carried an overview of unregulated stem cell treatments, including Berman's firm. 
• A Washington Post story about the 2018 FDA filing against Cell Surgical Network.

Stem Cell Video Flap: A Look at the Firm that Produced the "Docu-Series"

Bobby Sheehan discusses his personal and professional background in this YouTube clip.

Who are Bobby and Sara Sheehan, not to mention Working Pictures? 

It is a question that arises from their controversial "docu-series" that raised a ruckus this week in the small world of stem cell science.

Their online video, "Healthcare Revolution," was an unpleasant surprise for at least 12 scientists and other experts who learned only a few days ago they were appearing in the production. All of them asked to be removed.

They believed that they had been misled about how interviews that they had given many months ago were going to be used. 

They objected to sharing an electronic platform with dubious enterprises that are current targets of the federal government's actions to shut down dangerous and unproven stem cell treatments. 

Executives of those firms also appeared in the video in a manner that was considered a case of "false equivalency."

Earllier this week, the California Stem Cell Report queried Sara Sheehan about the video and their links to a California stem cell firm, Cell Surgical Network, with 100 national affiliates that the Food and Drug Administration is suing. 

The full text of her response runs below. But first a little background drawn from the Internet.

Sara Sheehan is executive producer for Working Pictures, according to its web site.  Her husband, Bobby, is producer, director, writer and cameraman. Their web site says Bobby had a "nomadic and slightly feral" upbringing. It also said, 

Sara Sheehan
 Working Pictures photo

"Collectively, they have produced well over a hundred hours of content in the form of online and conventional TV series, documentaries, and narrative films. Bobby has directed and lensed over 300 commercials…and they have produced three talented children."

The Sheehans are also associated with another enterprise called "Mortal," which deals with death and spiritual awareness. 

The California Stem Cell Report asked Sara Sheehan about the cost of the stem cell docu-series, which was partly financed by Cell Surgical Network, and any other financial ties with that firm.  Here is the verbatim text of her reply.

"I appreciate your asking us to provide additional information and I have answered your questions below: 

"We set out to produce a documentary series about the very complex regenerative medicine landscape. There is a lot of information out there and consumers are faced with a daunting amount of opposing opinions and concerns. We felt that by showing the entire landscape - including advances in research that will be providing hope to patients years down the line, the fact that many consumers are going overseas for treatments, the legislation that has been enacted in this country, patients who have gotten treatments in this country and other countries and their outcomes, and the lawsuits- we would educate the consumers who would see this and allow them to make the best decisions for themselves and their loved ones. 

"We looked for financing for the series, which took a year to make. We had investors, Drs. Berman and Landers (of Cell Surgical Network) were part of that team. Never did they ask to see edits, to control the content or interfere with the story in any way. That was the deal. The rest of the costs we bootstrapped ourselves: our investors did not pay us for our time and we covered many costs ourselves. We are not connected in any other way to Cell Surgical Network or any other regenerative medicine provider, nor do we stand to benefit financially from any procedures or products being marketed. We have no family members connected to Cell Surgical Network or any other regenerative medicine providers. The bottom line is that we are filmmakers who attempted to outline what is clearly a heated and emotionally charged environment. Ironically, Cell Surgical Network is featured most prominently in an episode entitled The Lawsuits, outlining the cases against US Stem Cell and Cell Surgical Network. We had updated that episode to reflect the decision against US Stem Cell. 

"We never paid anyone to be interviewed. In fact I have NEVER paid anyone to be interviewed for this project or any other project.

"After a year of interviewing and editing as many and as varied voices as possible, the resulting series is 12 episodes long. We organized the information by subject and feel we had a comprehensive product that provided a good, basic overview of the field that included many opposing points of view. There is a tremendous amount of information contained in the series that we felt showed as much of the landscape as we were allowed to capture.

"Unfortunately, a number of people expressed concern about being included in the project and we immediately responded that we would honor their wishes to be removed."

LA Times on Stem Cell Video Flap: 'Infomercial,' Hype and How the Hooha All Began

The Los Angeles Times this afternoon reported on the uproar over a stem cell video has left some researchers across the nation incensed and calling the film an "infomercial" that ballyhooed unproven therapies.

Twelve scientists and other experts have asked to be removed from the video that was partly financed by a California firm that is being sued federal regulators to halt the potentially dangerous treatments.

The Times piece was authored by Pulitzer Prize-winning columnist Michael Hiltzik who has written previously about the unregulated stem cell industry. He said,

"If there’s anything that drives legitimate stem cell scientists up a wall, it’s their being lumped in with clinics offering unwary customers supposedly effective disease treatments through stem cell injections."

The firm that helped fund the "Healthcare Revolution" is Cell Surgical Network, which is based in Southern California but has 100 affiliates across the country and more overseas. The Food and Drug Administration has sued the firm to halt the use of what it calls unproven and potentially dangerous treatments. 

The film was produced by Bobby and Sara Sheehan over the period of about a year. Hiltzik wrote,

“'It’s a package that’s very misleading and not balanced,' says Evan Snyder of Sanford Burnham Prebys Medical Discovery Institute. 'It was pitched like it would be a ‘Nova,’' he said, referring to the scientific series produced for the Public Broadcasting System, 'but it came out like an infomercial.' 

"Lawrence S.B. Goldstein of UC San Diego says he was led to believe the producers were making a 'balanced, sober documentary.' The trailer for the series posted on its website, however, was infused with hype—'It sounded like miracle cures from stem cells are here today—‘Give us your money and we’ll fix you up,’ giving false hope to people suffering from terrible diseases.'”

The Times piece laid out how the flap erupted just days before the video was to begin today. Hiltzik wrote,

"It was only last week that the true nature of the project emerged. That’s when Cell Surgical Network sent customers and former customers an email announcing the documentary’s upcoming premiere. The email landed in the in-box of Doris Tyler, a Florida resident who is suing Cell Surgical Network and affiliates for allegedly leaving her blind via a stem cell treatment for an eye condition.

"Tyler alerted her attorney, Andrew Yaffa, who passed the alarm on to Loring at Scripps. Loring scanned the documentary’s website and noticed that she and numerous academic colleagues were featured along with purveyors of unproven treatments. On June 13, she says, “I sent messages to everyone I knew” on the roster of participants.

"Subsequently, Sheehan disclosed that Cell Surgical Network had partially funded the series, deepening the alarm and prompting most, if not all, the academic participants to withdraw. 

“That was the kiss of death for me,” Loring told me. “I do not want to be associated with those guys at all.'”

Loring said in a letter to the Sheehans,

 "You have placed my interview among those of people who are charlatans and thieves...."