'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/ "

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.

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. 

Captain Kirk, Snake Oil and Stem Cell Treatments

It's time for stem cell whack-a-mole.

That's the game where regulators -- coming in late -- try to prevent snake-oil clinics from harming desperate patients with purported stem cell treatments and ripping off them for thousands of dollars.  

More than 1,000 dubious clinics are estimated to exist across the country with the largest number in California, which is lagging in its regulatory efforts.  More spring up every day with even Captain Kirk of Star Trek weighing in on the alleged benefits of the unregulated procedures.

William Wan of the Washington Post captured the national scene in an article late on Friday. He said don't get too excited about a favorable court decision involving one operation in Florida, which claims to turn body fat into beneficial stem cells.

Wan wrote,

"(T)he company said it would follow the federal judge’s ruling and stop selling the fat-based procedure. But it quickly followed up with a clarification: It would continue offering stem cell treatments, but instead of fat, rely on patients’ bone marrow and other tissues to harvest the cells it claims can cure conditions as varied as spinal cord injuries and erectile dysfunction.

"'It’s a bit like playing whack-a-mole,' said Peter Marks, FDA’s top official for biologic products."

The situation has been building for long time. Wan wrote,

“After years of largely ignoring the issue, the FDA is finally making more of an effort, but it’s not as if this marketplace is melting away,” said Leigh Turner, a bioethicist at the University of Minnesota. 

"Because no one had documented exactly how many stem cell clinics existed, Turner — working with collaborators (UC Davis researcher Paul Knoepfler) — began tracking them in a database several years ago. In 2009, there appeared to be only two in the United States; by 2017, there were at least 700. Turner believes there are currently more than 1,000."

"Turner compared the for-profit stem cell industry to a balloon. As the FDA and consumer advocates squeeze one end, other parts of the enterprise expand. 'For every one that’s disappeared, we’re finding seven more that are popping up.'"

Wan noted another effort in California that could affect a number of clinics. 

"Meanwhile, the government is pushing forward in a second federal court lawsuit against another stem cell business in California. That lawsuit has the potential to halt the fat-based stem cell treatment in multiple clinics because the government filed it against a company called Cell Surgical Network, which serves as an umbrella for dozens of affiliated clinics around the country."

An attempt to step up state regulation in California, however, has ground to a halt. Legislation (AB617) by Assemblyman Kevin Mullin, D-San Mateo, is now not even on life support. It is buried in the Assembly Appropriations Committee. Its content could surface in another measure that still has some technical life in the Capitol, but the outlook is more than dim. 

The scene is not much brighter with California's medical board. Last year said it would look into the dubious clinics. In April, it said hearings might begin no later than early this month. Nonetheless, a check of the agency's web site this weekend did not turn up any notice of such a meeting.

Legislation to Regulate 'Snake Oil' Stem Cell Clinics in California Hits Fiscal Speed Bump

California legislation to crack down on "snake oil" stem cell clinics has stalled after a cost of $100,000 was assigned to the measure, which is backed by the state's stem cell research program. 

The bill was sent last week to a "suspense" file, which holds fiscal legislation while lawmakers juggle priorities in the Golden State's yet-to-be-approved, $213 billion budget.

If all goes well, the measure could clear the Assembly Appropriations Committee in the next month or so and be sent to the floor of the Assembly. It would then go to the Senate for more committee hearings and a Senate floor vote.

No public opposition has yet surfaced to the measure (AB617), authored by Assemblyman Kevin Mullen, D-San Mateo. It would not take effect any earlier than 2020.

The bill would 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. 

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. 

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 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 group could also recommend emergency regulations that could be adopted by the state Medical Board with a 90 day notice. 

Last week, a committee of directors of the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known, endorsed the bill. The full board is expected to ratify that endorsement on Thursday. An analysis prepared by the legislative staff already lists CIRM as a supporter. 

The Odd Stem Cell Position of the Golden State: Hype, Hope and Dubious Clinics

The California stem cell agency and the Golden State's robust scientific stem cell community received some notice this week in the the Los Angeles Times, the state's largest circulation newspaper. 

It came in the form of an op-ed article that decried the booming business enjoyed by unregulated stem cell clinics, a field where California leads the nation. The Times says it has 1.4 million readers daily and 2.4 million on Sunday.

Usha Lee McFarling, a Pulitzer Prize-winning journalist and currently an artist in residence at the University of Washington, wrote the article discussing the issues surrounding the dubious clinics and their considerable risks, which do not seem to discourage those seeking help. She said,

"So why do patients keep streaming in for treatments that cost thousands of dollars? Part of the reason, I suspect, is that stem cell research — the serious, scientific kind — has gotten so much hype in recent years. We’ve all heard about how some stem cells have the power to become any type of cell in the body and might one day offer cures for all manner of crippling and degenerative diseases. If you can jump the line, and get those treatments now, why not do it? 

"Here’s why: Because the days of miraculous cures, if they come, are far in the future. Today, there is only one federally approved stem cell product: the limited use of blood-forming stem cells to treat certain blood disorders. Scientists are just beginning to learn how to harness the power of stem cells, and the harsh reality is that clinical trials that could turn that knowledge into effective therapies will take years, if not decades."

McFarling continued, 

"California is in an odd position. It is the state with the most stem cell clinics in the country offering these unproven 'cures.' It also happens to be a world center of serious scientific stem cell research, thanks to a $3-billion ballot initiative, Proposition 71, passed by voters in 2004 to fund research."

She noted the fledgling efforts at the state and national level to deal with the dubious clinics. McFarling wrote, 

"Here’s an idea in the meantime. The many scientists who have benefited from taxpayer support of stem cell research in the state should start speaking out. After all, the hype from proponents of Prop. 71 (which created the state stem cell agency) is part of what created such high expectations for quick cures – and eagerness on the part of patients to get them. Scientists should now take every opportunity both to explain to the public the long-term goals of their research and the absurdity of the so-called cures now flooding the market."

Our take: Her advice to California researchers is sound. However, it should be noted that a number of researchers, notably Paul Knoepfler at UC Davis, have been sounding warnings for years. The mainstream media, meanwhile, largely ignored the problem. It took two scientists to do the legwork, which could have been done by journalists as well, that has been the key building block behind the current regulatory efforts, which are still in their infancy.

Hype and Fraud and Their Impact on the California Stem Cell Program

Cartoon by Johan Thyberg from "For Better Science"

The New York Times this week published a piece about how the lust for success could be corrupting science in a greater way. 

The questions it raises have particular relevance in the stem cell field, which is still very much in a formative stage. 

Aaron Carroll, a professor of pediatrics at the University of Indiana, produced the opinion piece for the Times. He wrote, 

"How might grant funding and career advancement — even the potential for fame — be biasing researchers? How might the desire to protect reputations affect the willingness to accept new information that reverses prior findings?"

He also said, 

"Moves toward open science, and for a change in the academic environment that currently incentivizes secrecy and the hoarding of data, are perhaps our best chance to improve research reproducibility Recent studies have found that an alarmingly high share of experiments that have been rerun have not produced results in line with the original research."

Questions arise with some regularity about hype and fraud in stem cell research. Back in 2014, bioethicist Art Caplan asked, “Why so Much Fake, Unduplicable Stem Cell Research?”

Just this past fall, a multimillion-dollar stem cell research scandal involving Harvard surfaced once again in the news.

Credibility, of course, is everything in science. For the California stem cell agency, it is a matter of survival. It will be out of cash for new awards in less than 12 months and is hoping voters will then give it an additional $5 billion.  More news about stem cell hanky panky, wherever it occurs, will not serve the agency well when it makes its pitch once again to the people of the Golden State.  

Serious Infections and Fecal Contamination Alleged; Feds Battle Rising Tide of Dubious Stem Cell Clinics

The federal government last week stepped up its efforts to curb dubious stem cell clinics, declaring that 12 persons have been hospitalized for infections as the result of treatments involving a San Diego firm.

Some of the products from the firm have been found to have been contaminated with fecal bacteria . 

The federal action (see here and here) comes after years of ignoring the problem, both by the Food and Drug Administration and state regulators. Meanwhile, the growth of unregulated clinics as multiplied. Current estimates are that as many as 700 or more clinics exist in the United States, compared to at least 570 in 2016. 

California has the biggest share of the clinics, which is not unusual since it is the most populous state in the nation. Legislation backed by the California stem cell agency is expected to be introduced in California next month to step up regulation of dubious clinics.

The federal enforcement action came in the form of a "warning" letter from the FDA and involved a firm called Genetech (no relation to the well-respected biotech firm Genentech, but obviously a name designed to lure unsuspecting patients.)

The FDA said 12 patients have contracted serious infections as the result of injections involving Genetch procedures and products. The Center for Disease Control has reported that some of its unopened products contain E. coli and E. faecalis.

Genetech has not responded to multiple efforts by media to obtain a comment on the federal action.

Some stem cell scientists, most prominently UC Davis researcher Paul Knoepfler, have warned repeatedly for years about the unregulated treatments. In addition to the harm to patients, they have noted that the activities of the dubious clinics damage the reputation of the field in general. (See here, and here and here.

California Setting Stage for Crackdown on Dubious Stem Cell Clinics

The California stem cell agency, state regulators and lawmakers are taking aim at the more than 100 dubious, unregulated "stem cell" clinics now operating in the Golden State.

The goal is to curb clinics that are using what they describe as stem cells in treatments costing thousands of dollars but that have not been tested  scientifically. Lawsuits have been filed around the country alleging damage to patients that includes blindness.

Art Torres, vice chairman of the state stem cell agency, is now  working with lawmakers to formulate legislation that is expected to be introduced by the end of January.

At the same time, the State Medical Board, which licenses and regulates physicians, has chartered a task force to look into the the growing business.

Earlier this fall, Torres told the governing board of

Kevin Mullin, LA Times photo

the California Institute for Regenerative Medicine (CIRM), as the agency is formally known, that he was engaged with Assemblyman Kevin Mullin, D-San Mateo, on a bill.

Torres, a former state lawmaker, said the legislation is expected to involve certification of clinics by a state department. He said, 

"It involves a number of issues which we (CIRM) really can't be involved with in terms of licensing, but we certainly can be involved with the parameters and the distinctions that we ought to raise as to what constitutes an appropriate stem cell clinic in California."

The Medical Board is scrutinizing the promotional practices and harm caused by the clinics with the intent of crafting regulations to curb abuses.  

The board's starting point is a report by the Federation of State Medical Boards, which says,

"There is reasonable concern about a growing number of providers and clinics in the United States that are undermining the field. Such providers and clinics have been known to apply, prescribe or recommend therapies inappropriately, over-promise without sufficient data to support claims, and exploit patients who are often in desperate circumstances and willing to try any proposed therapy as a last resort, even if there is excessive cost or scant evidence of efficacy."

Paul Knoepfler, a UC Davis stem cell scientist who has long been involved in examination of dubious clinics, has reported that at least 100 such clinics exist in California. 

Writing on his blog Nov. 30, Knoepfler said,

"Broadly, it may be going rapidly from the best of times to the worst of times for unproven stem cell clinics in the U.S., which would be a very good thing for patients and the stem cell field, if it actually happens. We’ll see."

Former Biotech Maven Steve Burrill Sentenced to Prison

Famed and legendary he was called. Now he is facing 2.5 years in prison.

Steve Burrill, wn.com photo

He is Steve Burrill, who once was a featured life science maven/financier/visionary at international conferences such as BIO, which attracts upwards of 16,000 persons annually. Burrill also conducted a well-attended stem cell conference in San Francisco that showcased California's stem cell agency shortly after it came into existence.

Burrill, who was based out of San Francisco, was sentenced this week for defrauding investors and falsifying his tax returns. He pled guilty to siphoning off $18 million from his companies.

Here are links to the news stories on the case: GEN News, STAT, Xconomy.

Combating Stem Cell Snake Oil: A Primer From a California Researcher

Hundreds of dubious, unregulated stem cell clinics exist throughout the country with the most in California. Desperate people seeking help have been maltreated and fleeced. What to do?

UC Davis stem cell research Paul Knoepfler has produced a useful guide to reporting dubious
activities along with a list of state and federal agencies that could have a role.

In an item on his blog last week, Knoepfler wrote,

"I would emphasize concrete reasons for concern such as the use of an unapproved stem cell drug product by the clinic, a physician practicing outside their area of expertise so putting their patients at risk, false marketing, and potential or documented (if they’ve already happened) patient harms.

"For some clinics that aren’t led by physicians, I would also emphasize the risks of non-physicians such as chiropractors or Ph.D.s doing procedures for which they aren’t trained or licensed. I think patients (or people communicating on their behalf) making complaints about clinics and their personnel will have the greatest impact."

Knoepfler continued,

"We can make a difference by pushing back on the worst clinics. Of course, not every action by those of us in the stem cell arena who are concerned about predatory clinics will hit a bullseye to make real change, but sometimes it has happened in the past and will happen again in the future too."

I would add that the activities and stories that emerge from these dubious enterprises damage the reputation of the field as a whole. Indeed, when I talk to folks in the general public, the clinics' offerings are the most often mentioned reference they have.

As California's stem cell agency moves closer to seeking more billions from voters in 2020, fraudulent stem cell activity could create much confusion about the legitimacy of the entire field. Supporters might want to keep that in mind. But critics should as well. Fleecing the public with unproven therapies is unhealthy for those who are swindled but also for society in general.

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

Piero Anversa -- NYTimes photo by Annie Tritt

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

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

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

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

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

A couple of highlights from the piece.

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

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

 Kolata concluded:

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

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

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

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

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

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

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

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

Fabrication and Stem Cell Research: A Tale of 31 Retractions (Maybe), $63 Million and Heavy News Coverage

Stem cell research fraud was big news this past week. It involved millions of dollars, the reputations of researchers and prestigious institutions, lots of wasted work and damage to the entire field. 

The case, which attracted international attention in the mainstream media, involves a prominent heart researcher, Piero Anversa, formerly of  Harvard, and requests for 31 retractions.  STAT/Retraction Watch broke the story in a piece written by Ivan Oransky and Adam Marcus. The New York Times, the Washington Post and other publications followed. 

As the New York Times summarized, Anversa "fabricated or falsified data in 31 published studies that should be retracted, officials at the institutions have concluded." Harvard has been fined $10 million by the federal government.  

Carolyn Johnson of the Washington Post quoted a California stem cell researcher:

"'This body of work has, for better or worse, been hugely influential,' said Eduardo Marbán, director of the Smidt Heart Institute at Cedars-Sinai Medical Center. 'Despite the fact that several prominent laboratories failed to confirm key findings, c-kit positive heart cells were rapidly translated to clinical testing in heart failure patients. … One can only hope that no patients have been placed at risk in clinical trials based upon fraudulent data.'"

Another California researcher, Benoit Bruneau, was quoted by the New York Times. 

"A couple of papers may be alarming, but 31 additional papers in question is almost unheard-of,' said Benoit Bruneau, associate director of cardiovascular research at the Gladstone Institutes in San Francisco. 'It is a lab’s almost entire body of work, and therefore almost an entire field of research, put into question.'"

Gina Kolata of the New York Times wrote, 

"Despite the troubling questions that had been raised about the stem cell work, the National Heart, Lung and Blood Institute began a clinical trial of injected stem cells for patients with heart failure.... 

"In the past few years, however, skeptical researchers moved on to other prospects for heart treatment. 'The field has backed off a lot,' (Jeffery) Molkentin (a professor at the Howard Hughes Medical Institute) said.

"Some scientists wondered how a questionable line of research persisted for so long. Maybe, Dr. Molkentin said, experts were just too timid to take a stand."

Some researchers have called for suspension of the $63 million clinical trial, including Deepak Srivastava, president of the Gladstone Institutes and president-elect of the International Society for Stem Cell Research.

Here are links to other coverage of the matter, which is been brewing for several years: The Niche, The Scientist, Medscape, Biospace and the  Harvard Crimson.

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

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

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

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

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

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

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

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

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

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

Hiltzik concluded,

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

California Moves to Protect Patients Seeking Unregulated Stem Cell Treatments

Beginning next year, California will have a new law that imposes the first-ever disclosure requirements on currently unregulated stem cell clinics that offer therapies that have not been approved by the Food and Drug Administration.

UC Davis stem cell scientist Paul Knoepfler, who for years has raised concerns about such clinics, wrote an item yesterday about the new law for his blog. It was headlined:

"Groundbreaking new California stem cell law gives consumer protections on clinics"

Ed Hernandez, Daily News photo

The measure is the first of its kind in California and probably the entire nation.  Authored by state Sen. Ed Hernandez, D-West Covina, it will require clinics to specifically notify its customers that he or she is about to undergo a treatment not approved by the FDA. The notification also must include advice encouraging customers to consult their primary care physician prior to undergoing a stem cell therapy.

A legislative analysis of the bill, SB512, cited a statement from the Center for Public Interest Law that said, 

"It is critical to patient safety that these individuals are not misled into believing they are partaking in an FDA-approved clinical trial and assuming serious health and financial risks in the process. The disclosure notices required by this bill are an important step in ensuring that patients have the information they need before making such monumental decisions about their treatment."

Paul Knoepfler, UC Davis photo

Knoepfler co-authored a research paper in 2015 that documented  the presence of nearly 600  unregulated clinics nationwide with California leading the way. He wrote on his blog, 

"Taken together, the provisions of this law will help consumers learn more about the stem cell clinic industry, make better decisions about their health and that of their loved ones, and delineate the difference between stem cell clinics versus compliant researchers conducting stem cell clinical trials with FDA approval.

"In the big picture, this new California law plus a more active FDA on the stem cell front together give me more hope that the wild west of stem cell clinics can be reined in sooner rather than later! Perhaps other states will follow suit with new laws and state medical boards will get more involved in overseeing stem cell therapies. With more 570 stem cell clinics in the US and more than 100 here in California alone, more efforts like these are needed on the consumer protection and educational outreach front."

Knoepfler deserves great credit for his efforts regarding unregulated clinics. It is fair to say that without his work, California would not have seen this law at this time. He was the first to document the size of the industry with the 2015 article, co-authored by Leigh Turner of the University of Minnesota.  Their work makes it abundantly clear that scientists can make a real difference on public policy issues if they are persistent and effective. One of Knoepfler's key tools was blogging, a practice that some scientists think is less than dignified. Nonetheless, his blogging helped to elevate the issue and served as a source for the news media as they looked into the matter. 

Like most new state laws, the law takes effect Jan. 1, 2018.

A "Blind" Warning to Patients: Beware Unproven, Unregulated Stem Cell Treatments

“Disastrous” is how the New York Times this week described an ostensible stem cell treatment in Florida that left three older women blind or nearly blind. "Chilling reading" said the $3 billion California stem cell agency.

If you haven’t read about the matter yet, it is worth some attention. Denise Grady of the New York Times wrote,

“The cases expose gaps in the ability of government health agencies to protect consumers from unproven treatments offered by entrepreneurs who promote the supposed healing power of stem cells.”

Her article was based on a report in the New England Journal of Medicine that dug into the medicial and scientific details.

The matter involves loosely or non-regulated stem cell treatments in clinics that have shot up around the country, Paul Knoepfler, a stem cell research at UC Davis, and Leigh Turner, a bioethicist at the University of Minnesota, reported last year that at least 570 exist around in the country, with the most in California.

Kevin McCormack, director of communications at California's stem cell agency, wrote about the Florida matter on the agency's blog, He said,

"The report makes for chilling reading."

McCormack said it is a "warning to all patients about the dangers of getting unproven, unapproved stem cell therapies."

Knoepfler wrote on his blog,

“Is this just the tip of the iceberg for negative stem cell clinic outcomes given that there are around 600 such clinics in the US today largely operating generally without FDA approvals, lacking preclinical data to support what they are doing, and experimenting on thousands of patients for profit? 

“Where was the FDA in all of this and are they doing anything about it now?”

Knoepfler continued,

“The clinicaltrials.gov website remains a great, but also very problematic resource. Many patients seem to view anything listed on there as a legitimate, NIH-approved full-blown clinical trial and some clinics encourage that view, but that’s clearly not the case. I interviewed the leader of clinicaltrials.gov in 2014 and problems were already apparent to me back then from that discussion. Clinicaltrials.gov needs to provide patients with much more information (e.g. IND status, fee as inclusion criteria, etc.) and consider excluding certain listings.”While it is quite possible that it lacks the budget, the flexibility, and/or the authority to make such changes quickly, a lot is at stake. They need to make changes ASAP.”

'Hands Off My Cells' -- Reaction to Proposals to Change FDA Stem Cell Research Rules

A California scientist has plunged into the jungle of 4,000-plus comments dealing with the federal government's proposal to change regulation of stem cell research and has discovered an intense sense of ownership on the part of many. 

Paul Knoepfler of UC Davis yesterday wrote on his blog,

"In fact more than 700 use the exact same phrase 'My cells are MY cells' and it looks like hundreds more comments have the exact same or similar language is used in more extensive forms. 'My cells are my property.'  'My cells are mine.'" 

In all, Knoepfler said that the Food and Drug Administration(FDA) had received 4,251 comments by the time the comment period closed. The comments showed a clearly organized effort by one segment of the public. He said the general sense of many was:

"Keep your hands off my cells!"

Knoepfler wrote,

"It would seem the point is that these particular commenters believe that cells taken from their bodies should not be regulated as drugs under any circumstances.

"Everyone is of course entitled to their own opinion, but cells can be drugs if they are changed or used in ways that are not homologous because these factors make them have higher risk to patients. To ask for cells to never be regulated as drugs is asking for chaos and many harms to patients, but people may not realize that."

California's $3 billion stem cell agency is among those seeking changes in the FDA guidelines. The FDA has not set a public timetable for action on new rules, which Knoepfler and others have said are needed to deal with "an out-of-control, direct-to-consumer stem cell clinic industry."

Knoepfler surveyed the industry earlier this year and reported nearly 600 unregulated clinics operating nationwide. It was the first time that the size of the industry has been documented.++

California's Randy Mills: Flood of Demand for Stem Cell Therapies Requires New Development Pathways

The president of the $3 billion California stem cell agency today told federal regulators that patient demand is "very real" for stem cell therapies and called for "alternative" pathways for development.

Randy Mills at FDA hearing

Randy Mills said patients are "really suffering and their needs are not being met." He said the demand is like a flood of water and will find its way around any blockages that rise up.

Mills spoke during the first day of a two-day hearing by the Food and Drug Administration(FDA) into possible new regulation of the stem cell field.

The session came as the Washington Post published online a lengthy piece about unregulated stem cell therapies and the increasing scrutiny they are facing from regulators. Reporter Laurie McGinley wrote about a clinic in Beverly Hills with a self-described "Time Machine" box.

Mark Berman, who was described as the co-founder of the "biggest network of commercial stem cell clinics" in the country, processes stems cell through the box for a procedure that he says doesn't require FDA approval.

McGinley wrote,

"In mini-liposuction procedures, Berman extracts fat tissue from patients and puts it into the Time Machine box, where a centrifuge separates stem cells from fat. The cells are then injected back into the patients to supposedly treat a variety of health problems, such as arthritic knees, heart disease, amyotrophic lateral sclerosis and even autism."

The treatments run about $8,900 each. Berman said his network has treated about 5,000 persons, McGinley reported.

The Post piece said that such treatments and their regulation or lack of regulation has "ignited a fierce debate among physicians, patients, scientists and politicians about whether the (FDA) should crack down on therapies that critics deride as snake oil but that some patients swear by. And it is fueling a broader, longer-term debate over how cellular therapies should be regulated."

Stem cell researcher Paul Knoepfler of UC Davis , who is quoted in the Washington Post article, took in today's FDA hearing from his lab in California. Writing on his blog, he delivered some "take-homes" after the session concluded. Here are a few excerpts from what Knoepfler wrote.

• "Some speakers advocated for a 'middle ground' between 'nothing' in the way of regulation for instance of the dubious clinics and the perceived 'mountainous' extreme of the current FDA oversight system. The middle ground was, for example, argued for by Janet Marchibroda of the BPC and then also in the next talk by CIRM President Randy Mills. Mills, who is a very powerful speaker, argued that there is a harmful binary system now and we need a middle ground between the extremes of little-to-no regulation and the current in his view constricted pathway."
• "Several speakers invoked patient autonomy and patient rights, and argued that they are doing what they are doing as practitioners of stem cell therapies simply for the betterment of patients. There’s the pesky problem there with this argument of probably millions of dollars in profit being made from the patients by some clinics though. If it’s all about patients, I challenge the clinics to do the transplants strictly 'at cost' with no profit margin."
• "Many parties asked the FDA for more clarity and consistency on oversight. Also, a number of speakers asked for concrete, real world examples of how definitions would apply.  I’ve been pushing the FDA for increased clarity for years including lay abstract summaries of their main guidelines and statements of current thinking. I really like the idea of flowcharts."

'Unnerved' Researchers and Proliferation of Stem Cell Clinics: The Perspective from Los Angeles Times

The Los Angeles Times this past weekend picked up on the growing concern about the spread of dubious stem cell clinics triggered in many ways by a first-ever study by a UC Davis stem cell researcher. 

Pulitzer Prize-winning columnist Michael Hiltzik wrote,

"The proliferation of clinics nationwide offering stem cell therapies unnerves many researchers, who fear that unrealistic public expectations could undermine their own credibility. Patients with hard-to-treat conditions such as multiple sclerosis and Parkinson’s are easy marks who can be led to forgo established therapies in favor of unproven ones."

The headline on Hiltzik's piece said,

"These new stem cell treatments are expensive — and unproven"

Hiltzik interviewed a California lawyer who is working in the field. Hiltzik wrote,

"'Stem cell scientists include the best and the brightest doing great work, and I admire them,' says Janice Mulligan, a San Diego attorney currently assembling evidence for a potential class-action lawsuit against unnamed stem cell clinics. "At the other end of the scale, there’s snake oil.'"

Hiltzik also spoke to Paul Knoepfler, the UC Davis researcher who co-authored the study about stem cell clinics with Leigh Turner of the University of Minnesota. Hiltzik wrote,

"In an article just published in Stem Cells Translational Medicine, Knoepfler described his visit to one informational seminar sponsored by a clinic pitching a $5,999 stem cell treatment to about 30 attendees. Each was given a pack of forms to fill out, including a credit application. The spiel, he reported, featured personal anecdotes and 'questionable medical claims' — including the assertion that '90% of patients had a 50% or better improvement.'"

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

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

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

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

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

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

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

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

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

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

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

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

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