For more than a decade, Kristin Comella, the chief science officer of US Stem Cell Inc., took to conference stages and appeared at health expos evangelizing the benefits of her company’s experimental treatments. By extracting fat through liposuction, then filtering out adult stem cells and reinjecting them into troubled tissue, US Stem Cell could achieve striking improvements, she said, be it to a torn knee, overstressed lungs, or a body suffering from Parkinson’s.
The idea had an obvious appeal: Your body is already endowed with resilient biological machinery and—with a little boost—can be the source of its own healing. You don’t need invasive surgery or harsh medicines to feel better. The problem, Comella would say, was the government. In April 2018, Comella appeared at a holistic wellness conference in Austin, Texas, to make her case for using a patient’s own bodily means of production without the interference of the Food and Drug Administration. “If the FDA tries to say that they own the cells in your body, you should be outraged,” she said, pacing the stage in all black and pumping her arms for emphasis, “and you should stand with me and tell the government that they don’t own our body, we own our body.”
A month later, the government cracked down. The FDA oversees certain so-called autologous treatments—those where a therapy is derived from a patient’s own cells—based on the degree to which the cells are modified and processed once they are removed. The agency decided US Stem Cell needed regulating. Citing the company for using unproven and unapproved methods, and for “significant deviations from current good manufacturing practice requirements,” the Justice Department, on behalf of the FDA, sought a permanent injunction against US Stem Cell and Comella, which would compel them to stop offering fat-stem-cell treatments. The injunction was granted by a federal court in 2019.
Comella, who is fluent in the idiom of power struggle, saw an opportunity. She resigned from US Stem Cell in 2019 and has rebranded herself as a defender of medical liberty. She advocates for stem cell therapy in media appearances, touting patient testimonials and arguing that regulation not only stymies innovation and encroaches on patients’ decisionmaking but, when applied to treatments derived from one’s own cells, sets a precedent that could lead to infringement on a person’s physical autonomy.
Comella taps into libertarian fervor, a suspicion of Big Pharma, and hints of 1970s feminism—“My body, my choice.” It’s a powerful rhetorical combination that has synced with the drumbeat of a health-freedom movement. In fact, in April 2020, Comella was one of the featured speakers at an inaugural Health Freedom Summit. The conference, held online, billed itself as a grassroots response to the Covid-19 crisis and was aimed at opposing “medical tyranny.” It featured a three-day lineup of speakers, including Andrew Wakefield—whose 1998 study linking the MMR (mumps, measles, rubella) vaccine to autism in children still influences parents, despite being thoroughly discredited—and the prominent anti-vaccination advocate Robert F. Kennedy Jr., whose Instagram account was recently removed for making repeated false claims about Covid-19 or vaccines. Many of the summit’s speakers railed against public health guidelines, vaccines, and “fake news,” and pushed detox regimens and fringe theories about the coronavirus. “We don’t trust Bill Gates when it comes to our health,” one of the conference organizers was quoted as saying in press material. “Nor do we trust his bedfellow Anthony Fauci. They may have a platform, but they do not have the power to control our lives.” Neither Comella, US Stem Cell, nor their attorneys responded to repeated requests for comment for this story.
The health-freedom cause comingles the streams of campaigns against mandatory vaccination of children, government oversight of unproven therapies, and, more recently, public health guidelines meant to curb the spread of the coronavirus, as well as the vaccines developed against it. It’s part of a resurgent American skepticism of scientific expertise. Often, these arguments are in lockstep with ideas promoted by media outlets on the fringe right, at times making unlikely bedfellows of talk-radio provocateurs and those pushing dubious science, as with the embrace of hydroxychloroquine by some right-wing circles last year as a putative treatment for Covid-19.
Therapies involving adult stem cells, which can differentiate into some other types of cells to repair or replenish a given tissue, hold enormous potential for treating injury or disease. They have been proven safe and effective for some narrow categories of use, such as certain bone-marrow transplants. But the field is relatively new, and conducting multiphase clinical trials to prove the safety and efficacy of cellular therapies derived from other sorts of tissue, like fat, takes time. Thousands of stem cell trials are underway at institutions across the country to see if the therapies help with conditions including diabetes, Crohn’s disease, and cancer. Most legitimate trials are designed with a control group, with treatments typically offered at no cost to patients, and only after obtaining their informed consent—which includes an acknowledgement that they might receive the placebo. Many of the trials on offer at for-profit clinics like US Stem Cell fall short of these standards.
A few minutes into her presentation at the Health Freedom Summit, Comella clicked to a slide titled “Sources of Adult Stem Cells,” illustrated by a stock photo of smiling white-coated physicians, one offering a thumbs-up. She suggested that—along with ameliorating a host of illnesses, ranging from diabetes to congestive heart failure to colitis—fat stem cells harvested from patients through liposuction might lend themselves to a promising treatment for Covid-19. “We could take stem cells from where they’re lying in storage, for example, your fat tissue, relocate those to an area where we need some extra help—in the case of Covid, we might need some extra help in the lungs—and inject the cells and allow them to go to work,” she said. She closed her remarks with another invocation of self-defense: “I want to encourage you to keep fighting for your own health.”
Stem cell treatments have become big business in the US. In the 2000s, prospective patients typically had to travel abroad to receive certain stem cell procedures, but in the past decade hundreds of new stem cell clinics opened in the US, and a considerable number of existing practices added stem cell or related offerings to their menus. Researchers like Leigh Turner, associate professor at the University of Minnesota Center for Bioethics, and Paul Knoepfler, a professor of cell biology and human anatomy at the UC Davis School of Medicine, have spent the past few years raising alarms about what they dub “medicine’s Wild West” and calling for more federal oversight as adverse events—including deaths—continued to accumulate as a result of treatments given by US clinics.
Companies including US Stem Cell have argued that cell-based treatments don’t need federal regulatory approval. The FDA uses the phrase “minimally manipulated” to exempt procedures such as bone-marrow transplants from its oversight, and stem cell outfits say their fat-based procedures should also fall under that category.
That argument was tested in a landmark case involving Regenerative Sciences, a Colorado company founded in 2005 that offered unproven stem cell treatments derived from a patient’s own bone marrow. In 2010 the FDA filed for an injunction to halt the procedures; when the company appealed, the FDA again prevailed in a 2014 decision.
At the time, some regulatory officials—even some higher-ups at the FDA—echoed industry concerns that too much government authority could suppress legitimate medical advancements. Scott Gottlieb, who had been an FDA deputy chief, wrote an op-ed in The Wall Street Journal arguing that the court’s judgment “could put the brakes on one of the most promising areas of medical research.” In an effort to avoid that kind of slowdown, in 2016 the agency established a fast-track route as part of the 21st Century Cures Act that allowed for smaller and shorter trials for therapies demonstrating early potential in the realm of “regenerative medicine”—a catch-all comprising treatments meant to repair or replace damaged cells or tissues.
That law accelerated what was already an explosion in the retail market for unproven stem cell therapies. Today there are more than 1,000 direct-to-consumer stem cell centers in the US, Turner tells me. These businesses tend to charge high fees, which typically are not covered by insurance. They often forgo placebo-controlled trials and largely keep outcome data under wraps.
At its multiple clinics in Florida, US Stem Cell has offered a variety of products, procedures, and services like cell banking, which involves extracting a patient’s own cells for later use. Comella started as US Stem Cell’s chief science officer in 2004, having earned a master’s degree in chemical engineering at Ohio State University and worked at companies, like Osiris Therapeutics, focused on developing regenerative-medicine products. Comella is not a medical doctor; she got a doctorate in stem cell biology in 2017 from an online program offered by the Panama College of Cell Science, a non-accredited virtual university based in Chitré, Panama. (Perhaps unsurprisingly, the founder of the college, Walter Drake, is an outspoken critic of regulating emerging stem cell science.)
Comella was a fixture on the conference circuit, where she promoted the company’s menu of treatments to audiences that typically included practitioners or potential patients. Onstage at a 2016 gathering in San Diego called the Revolution Against Aging and Death Festival, or RAADFest, she explained that her parent company comprised several businesses: a physician-training arm; US Stem Cell Clinic, LLC, a subsidiary for its retail clinics; the company’s former brand name, Bioheart, through which it would continue to seek FDA approval for particular products; and Vetbiologics, which offered stem cell therapies to pets and other animals, including racehorses and at least one skunk.
At a conventional scientific conference, Comella’s methods would have seemed unorthodox, if not alarming. Her presentation included close-up photos of skin lesions from “an experiment that we did where I got some of my friends and family convinced to let me burn their arms to see if I could heal it” with platelet-rich plasma and with a mixture of plasma and stem cells, she said. The photos suggested that the treated lesions healed more quickly. “I’m out of friends though,” she added, to a couple of laughs from audience members.
While US Stem Cell might have appeared to be doing brisk business, it was in fact cash-strapped and foundering. According to the company’s 2016 10-K filings, it generated just over $3 million in revenue. It spent only $919—that’s not a typo—on research and development; cost of sales for the year totaled more than $972,000, and the company spent another $3.2 million on marketing and administrative expenses. Meanwhile, the company’s CEO and director, Mike Tomás, made more than $1.3 million that year, and Comella more than $741,000. In the filings, made public in March 2017, the company disclosed that an audit indicated “the existence of conditions that raise substantial doubt about our ability to continue as a going concern.”
The same month, The New England Journal of Medicine ran an article citing case reports from three patients with macular degeneration whose fat stem cells had been harvested and subsequently injected into their eyeballs in an attempt to stave off vision loss. All three were set to take part in a trial run by Bioheart, now known as US Stem Cell, in 2015. In each instance, the patients experienced rapid, significant, and permanent vision loss as a result of the injections; two of the blinded patients sued. US Stem Cell settled out of court.
Critics of the stem cell clinics, like Turner at the University of Minnesota and Knoepfler at UC Davis, argue that autologous cellular therapies are ripe targets for promotional campaigns that play on how patients understand their own bodies. In short, those critics say, purveyors of these treatments profit by appealing to patients’ intuition, even when it flies in the face of scientific knowledge. Their concern is also driven by what the medical establishment delicately calls adverse events, which have included acute bacterial infection of the spine, pulmonary embolism, stroke, cardiac arrest, and even death. They say the solution—or at least a step in the right direction—is more federal oversight.
In the months following the NEJM report on the blind patients, the FDA ramped up its response—finally taking swift, public steps to rein in some clinics offering unproven stem cell therapies. It conducted inspections at the US Stem Cell Clinic in Sunrise, Florida, and then, in August 2017, it issued a warning letter to Comella and the company. The agency determined that the clinic’s processing of harvested fat tissue constituted more than “minimal manipulation,” which meant that, among other factors, its products were subject to regulation as drugs. The letter went on to describe violations including lapses in proper testing, labeling, and protective clothing. It also chastised Comella for delaying the inspection and denying the investigators access to employees. (In a presentation last year, Comella said she was simply trying to protect patients’ privacy.)
In the years since the events of the Regenerative Sciences case, Scott Gottlieb, who had by then become FDA commissioner, had all but reversed his stance. In a statement, he admonished the “small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products.”
The FDA warning brought Comella some mainstream national press coverage, including critical stories in The Washington Post and the Los Angeles Times. She continued to push the cell therapies, casting the intervention of regulators as a ploy to thwart scrappy upstarts while helping Big Pharma. “When the power to heal exists inside you, and those cells are just circulating inside your body at all times, there is nothing to patent, nothing to bottle, mass produce, and then sell back to the public,” she said at a conference for an organization she founded, the Academy of Regenerative Practices, in March 2018. “So pharmaceutical companies are not interested in this technology.”
As it sought new sources of revenue, she said, her company would be expanding its offerings. Later in the talk, as WIRED reported at the time, she suggested that the clinics planned to dabble in cancer vaccine production. The following month, US Stem Cell opened a new clinic within the giant central Florida retirement community The Villages to cater directly to elderly clientele. (It appears to have since closed.)
In May 2018, the FDA and the Department of Justice filed a complaint seeking a permanent injunction against the company and Comella herself, accusing them of endangering patients and maintaining subpar manufacturing standards for cell therapies. She claims that prosecutors offered her a way out—the lawsuit would be dropped if she agreed to stop providing the fat-based therapies altogether, and that she refused. In fact, US Stem Cell continued to expand its services, announcing in December 2018 that it would offer platelet-rich plasma therapy, as well as unproven treatments like ozone therapy.
Federal officials also filed a similar lawsuit against another network of clinics, including those run by California Stem Cell Treatment Center, which was involved in giving patients an experimental cancer treatment made from stem cells and a smallpox vaccine inappropriately obtained from a Centers for Disease Control and Prevention stockpile. That company, too, said it would fight its injunction in court.
In the wake of the FDA crackdown, Comella found sympathetic audiences on the far right, where radio or podcast hosts amplified her gripes with federal regulators. In January 2019 she joined radio host Ron Gibson by Skype on the fringe channel InfoWars. (InfoWars is run by infamous conspiracy theorist Alex Jones, who himself was reprimanded by the FDA last year for hawking sham colloidal-silver remedies as Covid-19 treatments.) “The challenge is that the FDA wants to deem these cells that are inside your body as a drug,” she said. “And my opinion is that the cells inside me are mine. I have chosen to fight for the rights of Americans to use their own stem cells.” Gibson then turned to a segment featuring Roger Stone, adviser to former president Donald J. Trump, riffing on special counsel Robert Mueller’s investigation. (Stone subsequently spoke at an Academy of Regenerative Practices event.)
In June 2019, a US district judge in the Southern District of Florida issued a decision in the lawsuit, holding that US Stem Cell clinics and Comella adulterated and misbranded stem cell products in violation of the law. She ordered the business to comply with FDA regulations—including ceasing unapproved fat-tissue procedures—and submit to close oversight.
Comella left US Stem Cell in September 2019 and devoted herself to a legal defense fund as well as an advocacy nonprofit called My Cells My Choice. The organization’s website sells $50 black T-shirts emblazoned with its red and white logo. In a slickly produced three-minute sizzle reel scored like a theatrical trailer, Comella sits in conversation with a filmmaker, teary-eyed. “In tens of thousands of patients, we can only point to a handful of adverse events, which get replayed on the front page of the newspaper and I get crucified for,” she says. “What I’m doing is fighting for the rights of the patients.” In the final moments of the clip, typewriter font clacks over Comella’s silhouette, spelling out “UNITED STATES V. KRISTIN COMELLA”—the specter of the federal government with all its firepower trained on her.
She continued to campaign, fundraising for My Cells My Choice and her legal fees, and has taught fitness classes. In October 2019, she appeared on a webcast hosted by an organizer of the holistic wellness conference Paleo f(x). She had appealed the case and was awaiting trial. And she was willing, she said, to risk her finances so that she could keep fighting for health freedom. “This is bigger than me,” she said.
“Do you have any health freedom left in this country?” former InfoWars host David Knight asked Comella in April 2019. His question served as part of her introduction to listeners, which also included plugs for Brain Force dietary supplements, sold through the channel’s online store. He went on: “Or will the government force some treatments on you, forcefully withhold other treatments from you? It’s a very big question here.”
The answer would forge the mutual embrace between two seemingly disparate sets of actors—vendors of unapproved, retail regenerative therapies and far-right media channels. Their agendas would converge on the tendency to cast government oversight as overreach, resistance as valiant struggle, and unbridled choice as an ideal worth fighting for. Such a framework tracks with a growing hostility toward health regulations in the US and a new surge in health-freedom advocacy in this tumultuous moment.
Politically charged battles over a patient’s right to receive unproven treatments in the US date back to at least the mid-20th century, Lewis A. Grossman, professor of law and affiliate professor of history at American University, tells me. In his forthcoming book on the history of health libertarianism, Grossman writes that the FDA’s attempts in the 1940s and ’50s to snuff out fraudulent herbal cancer remedies touted by a former Illinois coal miner, Harry Hoxsey, drew the agency into a protracted fight with various groups—among them evangelicals and right-wing extremists—who saw Hoxsey as a persecuted miracle worker.
In the 1970s, leaders of the radical far-right John Birch Society pushed false claims that the drug laetrile, derived from a purified form of the chemical amygdalin, found in apricot seeds, was a cure for cancer. Though the treatment ultimately appealed to patients of various political persuasions, the society was instrumental in early campaigns to legalize laetrile and in smuggling the drug into the country. The Committee for Freedom of Choice in Cancer Therapy, an influential pro-laetrile group, was made up largely of Birch members, The New York Times reported. Their rhetoric sounds familiar today: “There are a lot of us Birchers in the Laetrile movement because the John Birch Society has the guts to fight for what it believes in,” a member told the Times in 1976.
More recently, the Goldwater Institute, a conservative and libertarian advocacy organization, helped fashion the federal right-to-try legislation that President Trump signed into law in May 2018, which allows patients to seek access to experimental therapies directly from drug companies before they are approved. But since the law doesn’t require companies to provide the treatments or insurance to cover them, it has so far been little used, and its benefits to patients are likely to be limited, bioethicists and legal experts say—and may offer false hope.
Covid-19 accelerated opposition to government decisionmaking on health. As it became clear early in 2020 that the new coronavirus would cause a pandemic and that US public health guidance—social distancing, limits on gatherings and business operations—and the authorization of tests and treatments would be handed down from the very agencies that sought to police her former firm’s therapies, Comella joined growing calls to resist the advice of federal health authorities.
The organizers of the Health Freedom Summit, the private online seminar at which Comella spoke last April, call themselves Operation Flood—a reference to Operation Dynamo, during which civilian sea vessels self-organized to help evacuate allied forces trapped at Dunkirk in the famed World War II battle. The group’s tone relays this sense of besiegement. Inside a social network accessible only by paid subscription, the group’s leaders, Alana Newman and Stephanie Lind, share anti-vaccination propaganda and scripted talking points alongside instructional videos on topics such as “How to Protect Your Child from Child Protective Services.” In an interview with the British paper The Independent, Newman compared vaccination requirements to “medical rape” and suggested that a violent response might be in order should inoculation against the new coronavirus become mandatory. (Newman is quick to distance herself from Comella, and she tells me she has not kept up with her campaign, adding that the stem cell treatments warrant scrutiny.)
At the same time, the health-freedom movement insists that dubious therapies, including some claiming to treat Covid-19 patients, be made widely available. The FDA has caught on. In July 2020, the agency cautioned against using regenerative medicine products, including fat-derived stem cell therapies, purporting to treat Covid-19, as none have been authorized for patient use. In turn, the Department of Justice has moved quickly to block the marketing of fraudulent Covid-19 treatments. In February 2021, a federal indictment against Patricia Ashton Derges, an elected Missouri state representative, was unsealed; it alleged that Derges, a licensed assistant physician, made false claims about a purported stem cell treatment marketed through clinics she owns in southern Missouri, including touting the treatments as a potential Covid-19 cure.
On June 2, Comella and US Stem Cell lost their appeal. In his opinion, Judge Douglas H. Ginsburg wrote of the fat-tissue procedures: “The biological material implanted into the patient is not the same as that removed.” The ruling affirmed the judgment of the district court, which prohibits the clinic or Comella from performing the fat-tissue procedures unless or until they are proven safe and effective. “While the lay person may not think of stem cells as a ‘drug,’” Ginsburg wrote, the federal statute’s “definition of that word is expansive,” and includes any article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”
An FDA spokesperson called the decision “a victory for FDA’s work to stop stem cell clinics that place patients at risk through products that violate the law.”
It’s not clear whether US Stem Cell will survive the impact of the ruling; with the exception of reporting the sale of some securities in February, the company has not posted a Securities and Exchange Commission filing in more than a year. In a press release, Mike Tomás, the CEO of US Stem Cell, called the decision in the appeal “disappointing,” and the firm said it plans to “refocus on its animal health division while it evaluates its future opportunities for its human division.”
Meanwhile, Comella seems to have pivoted yet again, doubling down on her earlier flirtations with the anti-vaccination movement. “We need to stop the #covid vaccine now,” she wrote on Twitter on June 18. Without a hint of irony, she went on to retweet an article critical of the FDA that the tweet’s author had captioned with the line: “I love the sound of a house of cards falling in the morning.”
