The FDA v. Your Stem Cells: An Insider’s View

By A. Rahman Ford, PNN Columnist

Mark Berman, MD, is a key player in the escalating conflict between stem cell therapy providers and the Food and Drug Administration.

Berman is co-founder of the California Stem Cell Treatment Center, a California-based clinic that specializes in stromal vascular fraction (SVF) stem cells, which are autologous cells derived from adipose tissue --- a patient’s own body fat.

Berman and his partner are defendants in a federal lawsuit filed by the FDA. The lawsuit claims that SVF products are considered “drugs” and “biological products” under the  Food, Drug and Cosmetic Act, and thus subject to federal regulation.

In June of this year, a federal judge in Florida upheld the agency’s position in a similar lawsuit against another stem cell company.

Berman maintains that FDA regulations for autologous cells are illegal and wants to set the record straight on the motives behind the agency’s crackdown on stem cells generally and against him and his partner, specifically.

DR. MARK BERMAN

DR. MARK BERMAN

In Berman’s view, the FDA’s assault against autologous stem cells has far less to do with the health, safety and welfare of patients, and much more to do with three other factors:

  1. The pharmaceutical industry’s influence over FDA regulations.

  2. The unfairness of the FDA’s clinical trial process, which preserves the position of large companies at the expense of smaller ones.

  3. The medical establishment’s fear of the paradigm-shifting, market-disrupting effect of healing with one’s own stem cells.

Basic Training in Stem Cell Therapy

Berman was in many respects an accidental recruit to stem cell therapy. A cosmetic surgeon with a private practice in Beverly Hills since 1983, Berman is well known as one of the pioneers of facial rejuvenation using fat grafting.

In 2008, Berman was introduced to equipment developed by Dr. Hee Young Lee of Medikan that harvests fat in specialized syringes. Berman was intrigued and decided to purchase the equipment, which Dr. Lee said could also be used to isolate stem cells.

“Who knew? Plastic surgeons actually pioneered and advanced adipose stem cells,” says Berman.

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Over the next couple of years, Berman learned more about adipose-derived SVF and how to isolate it. He also started discussing stem cell trials on orthopedic cases with Dr. Tom Grogan, a colleague in orthopedic surgery.

After a fact-finding mission to Japan in 2010, Berman and Grogan agreed to see patients. One of those patients was Berman’s wife, Saralee, who had significant hip pain after years of running marathons. Saralee was treated with adipose-derived SVF and “has remained pain free to this day,” according to Berman.

Another patient came to Berman for a face lift and said she wanted to get it done because she was scheduled to have both knees replaced in the 2-3 months. Instead, Berman and Grogan treated her knees with SVF cells for free. She demonstrated marked improvement and long-term freedom from pain.

“After seven years, we did a touch-up procedure on her and she continues to be pain free and functional,” says Berman.

In 2010, Berman and urologist Elliot Lander, MD, founded the California Stem Cell Treatment Center. Although successful, Berman and Lander never thought their SVF business would last.

“We figured we’d be good for two or three years of service and then ‘cells in a bottle’ would come along and replace adipose-derived SVF,” Berman told PNN. “It turns out that personal cell therapy may be a massively transformative technology for a variety of reasons and we’re here to stay unless the FDA can illegally have their way with us to protect Pharma and Academia.”

Early on, Berman and Lander treated orthopedic conditions associated with chronic pain – arthritis, back pain and inflammatory conditions. Not only did their patients experience pain relief, they began reporting improvement in other ancillary ailments as well.

“We quickly realized that by filtering the SVF, we could provide the cells via an IV for any variety of conditions,” Berman recalls. “Acute concussion heals overnight. Chronic traumatic brain injury may improve in many cases. Parkinson’s frequently responds well. We’ve had some good response with multiple sclerosis, Alzheimer’s and muscular dystrophy. ALS has not had good results. We’ve seen improvements with chronic heart conditions, COPD, and radiation necrosis following cancer treatments.”

Combating the ‘Unproven’ Disinformation Campaign

Their discoveries led Berman and Lander to publish a SVF safety study involving over 1,500 patients with various degenerative, inflammatory, and autoimmune conditions. They also formed the Cell Surgical Network, a network of physicians who use the same equipment and protocols taught by Berman and Lander. To date, the network has treated over 12,000 patients.

Berman maintains with conviction that “there’s no drug as safe as your own cells.” In fact, he and his family have all had successful personal stem cell treatments, as have most of the affiliate physicians in his network.

Yet news stories about “unproven stem cell procedures” persist. And Google recently went so far as to ban advertising for “unproven or experimental medical techniques,” including most stem cell therapies.

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“It is sad and ridiculous that we can safely and effectively treat many people right now, but we’ve been fighting this false press that stem cells are dangerous and unproven when there’s virtually no danger and plenty of proof,” Berman says. 

“Saying it’s unproven denies how science advances. Most science does not rely upon placebo trials, something Pharma routinely takes advantage of to get a new version of an old drug on the market to exploit the public.”

The FDA As Proxy for Big Pharma

Berman has a theory why he and his partner have become targets of the FDA. It has to do with the power and influence of the pharmaceutical industry.

“When corporations get so big, and in this case actually finance government agencies, they end up controlling them in a variety of ways. They have many inside people that can facilitate their needs, but they also have pushed the FDA to write draconian regulations to keep smaller players out of the club as much as possible,” Berman explained.

“Physicians have the obligation to try to help their patients when they can – not to sit around while some sanctimonious academics or Big Pharma or FDA regulatory people decide we can try,” he adds.

Berman poses an intriguing question.

“Isn’t it interesting that no major pharmaceutical company has applied for an IND (new drug application) for personal cell therapy?” he asks.

“The answer is obvious: because they can’t own it.”

Berman believes FDA regulations are designed to protect Big Pharma from competition.

The FDA has ignored clinicians’ and patients’ requests to be able to use their own cells for their own purposes. It’s absurd and it’s illegal.
— Dr. Mark Berman

“Surgeons used to perform a lot more coronary bypass surgery, but Pharma developed stents and drugs to compete for the same patients,” he says. “Pharma and academia are the only two voices that matter to the FDA. The FDA has ignored clinicians’ and patients’ requests to be able to use their own cells for their own purposes. It’s absurd and it’s illegal.”

Berman and Lander intend to fight the FDA in court to the very end. A hearing date was scheduled for this month, but has been postponed until early next year.

“They’re trying hard to ruin us through the press and through these extensively long and unfair court proceedings that have been dragging out for over a year. If it’s not clear, we’re fighting for the basic civil and constitutional rights of our patients,” Berman says.

“We should be achieving new heights in healthcare and freedom yet there are so many people more interested in controlling us than letting us naturally rise to thrive.”

A. Rahman Ford.jpg

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The information in this column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Stem Cell Therapy for Lower Back Pain Moves Closer

By A. Rahman Ford, PNN Columnist

There’s good news on the horizon for those who suffer from lower back pain due to disc degeneration.

Mesoblast, an Australian biotech company, has partnered with Grunenthal, a large German pharmaceutical company, to commercialize an investigational stem cell product called MPC-06-ID -- a stem cell formula comprised of mesenchymal cells derived from the bone marrow of healthy volunteers. Mesoblast could receive up to $1 billion from Grunenthal if the treatment is successful.

MPC-06-ID is currently in a Phase III placebo-controlled trial in the U.S. In the trial, millions of stem cells grown in a laboratory are injected into the patients’ degenerated discs with the goal of reducing inflammation and causing the discs to regenerate.

In previous trials, 47% of those who received the injection had a significant reduction in pain 12 months later. The results persisted for three years.

The estimated study completion date for the Phase III trial is March 2021. So, unfortunately, there is a bit of a wait. But Mesoblast is hopeful the study findings will result in FDA approval.

The company is also studying a stem cell product for chronic lower back pain. More on Mesoblast’s products and how they treat back pain can be found here.

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What does this mean? First and foremost, it’s great news for people suffering from back pain. This is a population that is woefully underserved by conventional medicine. Limited options include analgesics like opioids, which are increasingly difficult to obtain, and spinal surgery that is costly, often ineffective and can even exacerbate the problem. I have previously written about these issues here.

Clinicians around the country have been using stem cell therapy (SCT) for years to treat back pain and even difficult spinal conditions like arachnoiditis. However, these clinics have been operating under the scythe of potential persecution for using products not approved by the FDA.

Not only has this placed them squarely in the crosshairs of regulatory authorities which issue warning letters and file lawsuits, but it has also subjected them to internet censorship by Google and others.

The Mesoblast-Grunenthal partnership is indicative of the fact that major corporate investment in SCT is increasing -- and that can be a great thing for consumer choice. More and more biotech investors are recognizing that SCT is the future of medicine, especially when it comes to treating conditions caused by chronic inflammation. Forbes reports that the market size of the SCT industry was $8.65 billion in 2018, with a projected annual growth rate of 8.8%.

We saw recent evidence of this trend with Bayer’s acquisition of Bluerock Therapeutics’ and its stem cell treatments for Parkinson’s disease and other chronic illnesses. And Boston-based Vertex Pharmaceuticals recently acquired Semma Therapeutics for $950 million in a bet that its SCT products could cure type 1 diabetes.

Why is the SCT market so robust? Transparency Market Research attributes it to a “rise in consumer awareness.” In other words, people are desperate for relief and looking for new treatments. Suffice it to say, any additional treatment option for those suffering from back pain is more than welcome.

A. Rahman Ford.jpg

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The information in this column is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Online Censorship of Health Information Is Authoritarianism

By A. Rahman Ford, PNN columnist

Critics of stem cell therapy have taken their censorship campaign to another frightening and paternalistic step up the authoritarian ladder. Not only does it threaten freedom of speech, freedom of association and freedom of health, but now it’s targeting poor people.

The campaign to stop people from accessing stem cell therapy (SCT) has been building for some time. First there was fearmongering to scare patients away from SCT, followed by a push to have regulatory agencies increase enforcement.  Then came a call for social media platforms like YouTube to censor patient testimonials about the benefits of SCT.

Now, in a disturbing turn, critics are pressuring fundraising platforms like GoFundMe to purge campaigns that seek to raise funds for SCT.

In a recent op/ed in the BBC’s Future, London-based neurologist Dr. Jules Montague argues that crowdfunding sites like GoFundMe need to crackdown on patients seeking to raise money for stem cell treatments. Montague says their testimonials omit the “unfounded hype” and potential risks associated with SCT. These “bad actors,” according to Montague, should be banned to “halt the spread of misinformation.”

To propose that crowdfunding sites be tasked with choosing winners and losers in the marketplace of ideas, and to impose quasi-criminal sanctions on poor patients is to enter a decidedly dictatorial dimension. “Bad actor” is a legal term of art, and should be left to the jurisdiction of a court of law or other legislatively-authorized tribunal. That’s how things work in a democracy.

On the other hand, authoritarian regimes censor whatever speech they see fit, arbitrarily and without explanation. As it pertains to crowdfunding sites, what we absolutely do not need is unelected and unappointed “experts’” selling misplaced fears.

The question that should be asked is why do the SCT critics fear the agency of the people? Is the notion that people can make their own medical decisions – and accept the risks of those decisions – without “expert” stewardship, consultation or approval such a terrifying prospect?

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Ultimately, this “purge and censor” line of argument represents a slippery slope that is distinctly anti-democratic. And at the bottom of the slope, are piled the bodies of the sick, whose desperation is fueled by the abject failures of mainstream medicine.

Equally disturbing is the fact that stem cell censorship on fundraising platforms would be a clear and unmistakable attack on the poor. Poor people are the ones who need to raise money, not the wealthy. The average person doesn’t have the finances of a star athlete like Max Scherzer or a celebrity actress like Selma Blair to get stem cell treatment. Instead, they have to rely on the generosity of others, a generosity that crowdfunding sites facilitate. To censor SCT fundraising is to not only censor a voice, but a livelihood, and maybe even a life itself. Poor people should not be punished for being poor.

Does Dr. Montague really expect GoFundMe and other sites to establish their own internal ethics boards and become the online sentinels of poor people’s health? There is no defensible or rational justification for preventing chronically ill poor people from raising the money they need to save their own lives.

Online Censorship Increasing

Unfortunately, online censorship of alternative health information is not new. In fact, it’s increasing. Facebook recently deleted dozens of alternative health pages without any notice or explanation. Some, such as Natural Cures Not Medicine and Just Natural Medicine, had millions of followers.

GreenMedInfo was kicked off Pinterest for violating its “misinformation policy” which bans “false cures” for chronic illnesses. And who helps Pinterest determine what health advice is false?

“We rely on information from nationally and internationally recognized institutions, including the CDC and WHO, to help us determine if content violates these guidelines,” Pinterest explained in an email.

Recent changes to Google’s Broad Core Algorithms have also suppressed search results for alternative medical information. As a consequence, hundreds of health websites have experienced drastic drops in traffic, including Pain News Network. One website, owned by alternative health advocate Dr. Joseph Mercola, lost about 99% of its traffic.

“Big Tech has joined the movement, bringing in a global concentration of wealth to eliminate competition and critical voices,” Mercola warned. “This year, we’ve seen an unprecedented push to implement censorship across all online platforms, making it increasingly difficult to obtain and share crucial information about health topics.”

We’ve seen an unprecedented push to implement censorship across all online platforms, making it increasingly difficult to obtain and share crucial information about health topics.
— Dr. Joseph Mercola

Even Wikipedia, which relies on open source editing for its content, has succumbed to the “deletionism” of alternative health information.

“We believe that organised skeptic groups are actively targeting Wikipedia articles that promote natural, non-drug therapies with which they disagree,” says the Alliance for Natural Health. “The new trick of these editors is to rewrite or entirely remove pertinent information from such articles or, worse still, delete entire articles altogether.”

It now appears that stem cell therapy is the next hooded subject to be escorted into the Star Chamber of deletionism. The call for fundraising censorship is distinctly ant-human, and denies the most essential and primordial of human instincts – to assist a fellow human being in their time of need.

It is not the place of GoFundMe or any other fundraising site to police people’s medical choices. GoFundMe, your core principles are turning “compassion into action” and the sharing of people’s stories “far and wide.” Please do not capitulate to the SCT bullies.

A. Rahman Ford.jpg

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Professional Athletes Get Stem Cell Therapy, But Should You?

By Liz Szabo, Kaiser Health News

Baseball superstar Max Scherzer — whose back injury has prevented him from pitching for the Washington Nationals since he last played on July 25 — is the latest in a long list of professional athletes to embrace stem cell injections in an attempt to accelerate their recovery.

But many doctors and ethicists worry that pro athletes — who have played a key role in popularizing stem cells — are misleading the public into thinking that the costly, controversial shots are an accepted, approved treatment.

“It sends a signal to all the fans out there that stem cells have more value than they really do,” said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for high-quality care. “It’s extremely good PR for the people selling this kind of thing. But there’s no question that this is an unproven treatment.”

Stem cells and related therapies, such as platelet injections, have been used for the past decade by top athletes: golfer Tiger Woods, tennis pro Rafael Nadal, hockey legend Gordie Howe, basketball player Kobe Bryant and NFL quarterback Peyton Manning. Stem cells are offered at roughly 1,000 clinics nationwide, as well as at some of the country’s most respected hospitals.

Depending on the treatment, the cost can range from hundreds to thousands of dollars. Insurance does not cover the treatments in most cases, so patients pay out of pocket.

Yet for all the hype, there’s no proof it works, said Paul Knoepfler, a professor in the department of cell biology and human anatomy at the University of California at Davis.

By    Arturo Pardavila III     from Hoboken, NJ, USA

By Arturo Pardavila III from Hoboken, NJ, USA

Referring to Scherzer, Knoepfler said, “There’s really not much evidence that it’s going to help him, other than as a psychological boost or as a placebo effect.”

Scherzer, 35, said he received a stem cell shot Friday for a mild strain in his upper back and shoulder. According to a news story on the Major League Baseball website, Scherzer also previously had a stem cell injection to treat a thumb injury.

If the diagnosis of Scherzer’s mild muscle strain is correct, it should completely heal itself with 10 days of rest, Rickert said, so Scherzer would probably feel ready to play by Monday even without the stem cells. But Rickert said he worries about other athletes who are tempted to return to the field too soon.

“The risk from the stem cell procedure is that it could give someone a false sense of confidence, and they could go back to play too early” and reinjure themselves, he said.

A spokeswoman for the Washington Nationals declined to provide information about Scherzer’s treatment, such as the type of stem cells used or the name of the clinician who administered them.

Clinics that offer stem cell treatments prepare injections by withdrawing a person’s fat or bone marrow, then processing the cells and injecting them back into aching joints, tendons or muscles.

Another popular treatment involves concentrating platelets — the cells that help blood clot. Many people confuse platelet injections with stem cell injections, perhaps because the shots are promoted as treatments for similar conditions, said Dr. Kelly Scollon-Grieve, a physical medicine and rehabilitation specialist at Premier Orthopaedics in Havertown, Pa.

Placebo Effect on Pain

When it comes to pain, injections can act as powerful placebos, partly because suffering patients put so much faith in treatment, said Dr. Nicholas DiNubile, an orthopedic surgeon and former consultant for the Philadelphia 76ers.

In a recent analysis, more than 80% of patients with knee arthritis perceived a noticeable improvement in pain after receiving a placebo of simple saline shots.

Team doctors often treat athletes with a variety of therapies, in the hope of getting them quickly back on the field, said Arthur Caplan, director of the division of medical ethics at New York University School of Medicine. Athletes may assume that stem cells are responsible for their recovery, when the real credit should go to other remedies, such as ice, heat, nonsteroidal anti-inflammatory medications, cortisone shots, massage, physical therapy or simple rest.

“These are the richest, most highly paid athletes around,” Caplan said. (Scherzer and the Nats agreed to a $210 million, seven-year contract in 2015.) “So anything you can think of, they’re getting. But I wouldn’t use them as a role model for how to treat injuries.”

While athletes often talk about their stem cell treatments, Caplan said he wonders, “Would the inflammation or problem have just gone away on its own?”

Sports fans shouldn’t expect to have the same reaction to stem cells — or any medical intervention — as a professional athlete, DiNubile said.

In general, athletes recover far more rapidly than other people, just because they’re so young and fit, DiNubile said. The genes and training that propelled them to the major leagues may also aid in their recovery. “They have access to the best care, night and day,” DiNubile said.

Whenever a top athlete is treated with stem cells, word spreads quickly on social media. Fans often end up doing the stem cell industry’s marketing for them: A 2015 analysis found that 72% of tweets about Gordie Howe’s stem cell treatments were positive. Of 2,783 tweets studied, only one mentioned that Howe’s treatment, delivered in Mexico after Howe’s stroke, was unproved and not approved by the U.S. Food and Drug Administration. Howe died in 2016.

The Mexican stem cell clinic provided Howe’s treatment at no charge. Clinics use such donations as a form of marketing, because they generate priceless publicity, said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics who has published articles describing the size and dynamics of the stem cell market.

“Clinics provide free stem cell treatments or offer procedures at a discounted rate, and in return they can generate YouTube testimonials, press releases and positive media coverage,” Turner said. “It’s also a good way to build relationships with wealthy individuals and get them to refer friends and family members for stem cell procedures.”

Stem cell clinics often feature athletes and other celebrities on their websites and in marketing materials.

In a 2018 column, Los Angeles Times writer Michael Hiltzik noted that stem cell treatment has failed three baseball players with the Los Angeles Angels. Players Shohei Ohtani, Andrew Heaney and Garrett Richards, who is no longer with the Angels, tried stem cells in the past three years in an effort to avoid surgery. All ended up needing surgery anyway.

As DiNubile said, “the marketing is clearly ahead of the science, no question.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Stem Cell Fearmongering

By A. Rahman Ford, PNN Columnist

In a recent Canadian Medical Association Journal case report, Canadian researchers report the case of a 38-year-old man who suffered an adverse event from a very specific form of stem cell therapy – an olfactory mucosa graft.

Rather than simply present the medical particulars of the case itself, the authors proceed to make a broad indictment of stem cell therapy (SCT) as a whole. This politicization is unnecessary, irresponsible and patently unscientific.

Furthermore, it undermines the objectivity of the research itself and regrettably continues the trend of SCT fearmongering prevalent in certain mainstream publications like STAT and the Los Angeles Times, which immediately ran with the story, pushing a fear-based narrative.

In the procedure in question, nasal cells were transplanted into a spinal cord lesion that resulted from a spinal fraction that occurred when the patient was 20 years old, leaving him partially paralyzed .

He had the olfactory mucosa graft in Portugal at age 26 to potentially treat his pain and paralysis. The treatment was unsuccessful.

A dozen years later, the patient experienced deteriorating neurological function and doctors discovered a large mass on his spine “with mucinious material and tissue consistent with ectopic olfactory mucosa.”

This discovery confirmed the doctors’ preoperative diagnosis that the spinal mass was related to the stem cell procedure the patient had undergone years prior.

If the authors had stopped there, this could be considered an important contribution to the stem cell literature. Cases of adverse events from any medical procedure should be reported and taken seriously.

Unfortunately, the authors proceed much further to extrapolate wildly from their one very unique case of a very specific and experimental form of SCT. Rather than present the data and their scientific analysis, they stray into the political, diminishing the overall value of their work. Sadly, the paper reads more like an op-ed rather than objective peer-reviewed research.

The paper’s most glaring and egregious problem is that it lumps all forms of SCT together with no mention of the different types of cells, different tissues those cells come from, different methods of administration of those cells, and the differences in the clinics offering those therapies. These distinctions are critical and the authors’ failure to discuss them is troubling to say the least.  

Instead, the authors condemn the stem cell “industry” in toto, lumping cosmetic and medical procedures together, with no justification as to why the two are technically comparable, and lamenting the phantom maelstrom of SCT adverse advents that curiously has yet to materialize.

The authors then make a rather supreme leap in logic with the unsubstantiated claim that, “although some of the reported adverse events might relate to surgical technique alone, others are likely the direct result of the yet unproven treatments using stem cells.”

They provide absolutely no evidentiary basis for such a sweeping claim. If a claim cannot be supported by evidence then it should not be made. Otherwise, anyone who reads the claim might be left to make reasonable inferences about professionalism, undisclosed subjectivities and possible hidden agendas.

A. Rahman Ford.jpg

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

The Push for Stem Cell Censorship Has Begun

By A. Rahman Ford, PNN Columnist

A new study published in journal Stem Cell Reports, entitled “How to Peddle Hope: An Analysis of YouTube Patient Testimonials of Unproven Stem Cell Treatments,” looks at over a hundred videos by stem cell patients posted on YouTube. 

The study appears to have an underlying anti-democratic agenda – to shame YouTube and other internet platforms into removing positive patient testimonials about stem cell therapy (SCT).  Indeed, the use of the pejorative term “peddle” in the article’s title immediately undermines the study’s credibility.

This research epitomizes how propaganda can masquerade as scientific research, and how data can be twisted to meet its masters’ agenda.

The study comes on the heels of a recent federal judge’s decision that the FDA could regulate stem cells made from adipose tissue – a patient’s own fat cells. Although SCT critics generally praised the ruling as a victory for government oversight, outlets like the Washington Post lamented that it would likely not deter clinics from offering the therapy. 

A New York Times article accused the FDA of not acting until patients were harmed, and using enforcement actions that consist only of warning letters without any real teeth.  

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STAT News even criticized the National Institutes of Health for allowing stem cell clinics to “co-opt” the nation’s clinical trial database.

Stem cell critics have apparently realized that the three previous stages of their vilification campaign have failed. These stages were:

  1. Vilify the patients:  Promote the condescending narrative that patients are desperate, ignorant and too stupid to research stem cell therapy for themselves and decide whether it is best for them.

  2. Vilify the clinics: Stem cell clinics are run by shady charlatans who engage in duplicitous business practices that take advantage of desperate, ignorant and pitiful Americans by selling them “unproven” products that couldn’t possibly help them.

  3. Vilify the federal government: Federal agencies have not acted quickly or robustly enough to enforce the regulations that govern regenerative medicine, thus tacitly approving the growing “wild west” of clinics offering SCT.

The Push for YouTube Censorship

Critics now appear to be setting their sights on a fourth vilification stage.  In their desperation, they have decided to take a more authoritarian turn towards internet censorship.

The new study’s authors examined 159 YouTube testimonials from patients who had SCT for ALS, multiple sclerosis, Parkinson’s, cerebral palsy and spinal cord injury.  Not surprisingly, they found that most of the videos were published by providers and nearly all discussed the benefits of SCT in improving pain, overall health and quality of life. 

The authors concluded the YouTube testimonials “may be a potent marketing tool” and “are likely to have a wider reach and significant impact on influencing health behavior.” 

The article’s final sentence reveals the authors’ true motive: “Adopting multiple approaches, including patient education, enhancing patient treatment options, and regulatory oversight, are required to make a significant dent in reducing the number of clinics providing unproven SCTs.”

Setting aside the numerous, glaring and egregious methodological shortcomings of the study, the more important issue is one of broader public policy.  These authors appear to be implicitly advocating that YouTube and other internet sites censor videos that are “misleading” or “deceptive” or not published by “reputable organizations.” 

And who or what is to determine whether any particular video meets this criteria?  Wired published an article with the ominous headline “YouTube Testimonials Lure Patients to Shady Stem Cell Clinics,” implicitly calling on YouTube to take action. The notion isn’t farfetched. YouTube has been in the news a lot recently for censoring videos, using nebulous criteria and subjective standards.   

Apparently, SCT critics have jumped on the YouTube censorship bandwagon.  It’s a wagon that seems to claim a new victim every day, and its victims are usually those who threaten the status quo.  Unfortunately, it’s a wagon that travels the pothole-riddled road of authoritarianism.  It’s a road patrolled by people in strange uniforms, with sophisticated and articulate weapons, who dispense a vicious propaganda, and who always claim to have your best interest at heart.

Please make sure to call, email and/or tweet your state and federal legislators to voice your support for the availability and affordability of stem cell therapy.  The people who suffer with pain and disability will not be silenced and will not be censored.  Our democratic voice will be the response to their authoritarianism.

A. Rahman Ford.jpg

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Employers Adding Stem Cell Options to Insurance Plans

By Liz Szabo, Kaiser Health News

A Midwestern grocery chain, Hy-Vee, is taking an unusual approach to reducing health care costs. Before employees in certain cities can undergo knee replacement, they first must visit a stem cell provider.

Hy-Vee has contracted with one of the United States’ leading stem cell companies — Regenexx, based in Des Moines, Iowa — that claims injections of concentrated bone marrow or platelets can help patients avoid expensive joint surgery.

Regenexx has persuaded over 100 employers to include its services in their health insurance plans. In a marketing booklet, Regenexx, whose injections range in price from $1,500 to $9,000, notes that its treatments cost a fraction of major surgery.

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A single knee replacement ranges from $19,000 to $30,000 in the U.S.

Health insurance typically doesn’t cover stem cell injections, with the exception of certain accepted treatments, such as bone-marrow transplants for cancer and aplastic anemia.

Aetna, the United States’ third-largest health insurer, dismisses stem cells and platelet injections as experimental; Anthem, the country’s second-biggest health insurance provider, classifies the injections as “not medically necessary.” Without insurance coverage, patients are forced to pay out-of-pocket or forgo treatment.

So instead of dealing with disapproving insurance executives, Regenexx appeals directly to employers large enough to fund their own health plans. These businesses have the freedom to customize their plans, covering services that aren’t part of a standard insurance package.

In a statement, Regenexx said its goal is to “replace more invasive surgical orthopedics” with nonsurgical options, noting that recent research has found many joint operations are ineffective. On its website, Regenexx claims its procedures “repair and regenerate damaged or degenerated bone, cartilage, muscle, tendons, and ligaments.”

In a bone marrow stem cell procedure, for example, a doctor withdraws bone marrow cells from a patient’s hip, concentrates them, then reinjects them into a problem area, such as an arthritic knee. Doctors target the exact location in the joint using ultrasound. For a “platelet-rich plasma” treatment, doctors draw blood, concentrate the platelets, then inject them into the target area.

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Regenexx, previously known as Regenerative Sciences, is one of the oldest stem cell companies in the U.S. When it opened its doors in 2005, it had only a handful of competitors.

Today, there are more than 1,000 stem clinics in the U.S., said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics, who has published a series of articles describing the stem cell market.

At times, Regenexx has clashed with the Food and Drug Administration. In 2010, for example, Regenexx sued the FDA, claiming the agency lacked the authority to regulate its procedures, which involved culturing stem cells before reinjecting them into patients. Regenexx lost its case and was countersued by the FDA, which charged that Regenexx was marketing an unapproved drug. In 2014, the U.S. Court of Appeals in Washington sided with the FDA, forcing Regenexx to stop performing the controversial procedures.

Today, Regenexx performs this procedure only in the Cayman Islands, where the government allows it. The Cayman Islands, where there is less government regulation of health care, has become known as a medical tourism destination, Turner said.

Regenexx says that the treatments offered at its U.S. clinics comply with FDA regulations, which require that cells injected into patients undergo no more than “minimal manipulation.”

On its website, Regenexx lists more than two dozen studies led by its doctors. For example, its chief medical officer, Dr. Chris Centeno, published a small study last year that found patients with knee arthritis who received bone marrow and platelets fared better than those randomly assigned to exercise therapy.

Other research suggests stem cells and platelets may work no better than placebos. In a recent analysis, over 80% of patients with knee arthritis experienced a noticeable improvement in pain after receiving simple saltwater injections.

There’s also no definitive evidence stem cells and platelets can regrow lost cartilage. A 2018 review concluded platelets have “marginal effectiveness,” and experts note that most published studies are so small or poorly designed that their results aren’t reliable.

Corporate Boosters

Corporate executives have become some of Regenexx’s biggest boosters. Hy-Vee’s former chairman and CEO, Ric Jurgens, appears in a Regenexx marketing brochure and says that he turned to Regenexx because of heel pain. The brochure, which was removed from a Regenexx website after Kaiser Health News began reporting this story, quotes Jurgens as saying, “I knew that giving our employees the chance to explore options besides surgery was in their best interest.”

Hy-Vee did not make Jurgens or other employees available to interview.

Perhaps Regenexx’s best-known corporate client is Des Moines-based Meredith Corp., which owns multiple TV and radio stations, as well as magazines such as Better Homes & Gardens.

Steve Lacy, Meredith’s former CEO and current board chairman, said he underwent a Regenexx procedure two years after his company began covering stem cell treatments. He had been facing knee surgery and thought stem cells were worth a try.

The procedure got him back to doing everything he wants to do, Lacy said, even running several days a week. He also has done daily physical therapy for over two years. “The rehab and recovery is far less onerous” with the Regenexx procedure than with surgery, Lacy said. “If the procedure doesn’t work for an individual, there’s no harm.”

Meredith has spent about $400,000 in four years on 85 employees who have had Regenexx treatments, or about $4,700 a patient, said Meredith spokesman Art Slusark. That’s a small share of the roughly $75 million a year that Meredith spends on its medical plan, he said.

At its headquarters, Meredith has promoted Regenexx procedures through email, posters and “lunch-and-learn” sessions in the office, said Jenny McCoy, Meredith’s corporate communications director.

McCoy herself has become a poster child for Regenexx’s benefits. She and two other Meredith employees appear with Lacy in a marketing video on the Regenexx site:

Although McCoy had begun to experience knee and hip pain during exercise, she said in an interview that her pain was not severe enough to need surgery. McCoy underwent platelet injections two years ago and is pain-free today, she said.

“I thought, ‘If Meredith is covering it, I might as well have it done early before [the pain] causes me too many problems,’” said McCoy, 52. Given the price tag, she said, “I would not have done it otherwise. I wouldn’t have even known about it.”

‘Very Pushy’ Marketing

Some employers are, in fact, skeptical. The Des Moines Public Schools has opted not to add Regenexx to its employee health plan, said Catherine McKay, director of employee services for the school system. She said a salesman for a local stem cell clinic, which has since merged with Regenexx, told her the treatments could save the school system lots of money. McKay wasn’t sold.

“My experience with them has not been great, in terms of marketing and sales. They’re very, very pushy,” McKay said. “They claim they can get people back to work earlier” than surgery. “But if I still need knee surgery a year down the road, that doesn’t cut my costs.”

The Des Moines school system has agreed to consider covering Regenexx procedures as part of its workers’ compensation program on a case-by-case basis, McKay said. The school system has not signed a contract with Regenexx, however, and hasn’t included Regenexx in its health plan.

McKay said she knows of two school employees who have tried Regenexx. While one employee was satisfied with the results, McKay said, another “went through a couple procedures and ended up needing surgery anyway.” 

In response, Regenexx noted that many patients who undergo knee surgery are also unhappy with the results. Research suggests that up to one-third of those who have knees replaced continue to experience chronic pain, while one-fifth report that they are dissatisfied with the results of their surgery.

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.