State Attorneys General have recently filed actions against stem cell clinics that overstated their claims. We are going to look at several of these cases and see how the states are helping fill the gap caused by the lack of effective regulation.
Too many stem cell clinics make claims of effectiveness that are not backed by sufficient evidence for a number of conditions, including Parkinson's disease. Stem cell treatments have resulted in both financial and physical harms.
Regulation is playing catch up because stem cell therapies are new. The FDA regulates some therapies as drugs or biological products. Others are not. Stem cell clinics and the FDA are at odds over where to draw the line between the two.
Stem cell clinics can be regulated by the Federal Trade Commission, which has jurisdiction over unfair or deceptive acts or practices in or affecting commerce. This may prove to be a more efficient way to shut down questionable clinics because of the lack of evidence of effectiveness for most conditions.
States have their own consumer protection laws that are enforced by the Attorneys General. State AGs are allowed to initiate and conduct investigations and bring lawsuits on behalf of the states' citizens under these laws. The law only requires that deception was likely in order for false advertising claims to be found. These state laws are particularly useful for state AGs to hold companies liable for false or deceptive advertisements.
The New York Attorney General announced a $5.1 million judgment against a New York City stem cell clinic and its managing physician for misrepresenting their therapies. Stem cell treatments were not allowed to be marketed as fraudulent and deceptive.
The clinic advertised that it could treat a variety of serious medical conditions using patients' own stem cells.
Stem cells are a medical breakthrough in the treatment of many chronic medical conditions and there was a great deal of excitement about using them. Stem cells could be used to help people with diabetes avoid amputation and even help people with arthritis, according to the defendants. Stem cells can't effectively treat any of these conditions, as the AG noted.
Treatments were promoted using testimonials from well-known individuals such as Guardian Angels founder Curtis Sliwa without disclosing that they did not pay for these treatments, in effect paying them for their endorsements without letting the public know.
Several consumers paid over $20,000 for multiple procedures, and the defendants charged consumers nearly $4,000 per procedure. A lot of the procedures involved stem cells from a patient.
In August of last year, the Georgia Attorney General joined the FTC in filing an enforcement action in federal district court against Regenerative Medicine Institute of America, Stem Cell Institute of America, and several other corporate and individual defendants for violations of the Georgia Fair Business Practices Act.
The complaint alleges that the defendants made false and misleading claims about stem cell therapies offered to consumers in Georgia, aggressively marketing and selling these therapies to older adults. They advertised to the public and healthcare practitioners that their therapies cure, treat, or mitigate a variety of orthopedic diseases and health conditions, and that they are comparable or superior to conventional treatments for these conditions. The claims are not backed by reliable scientific evidence.
According to the complaint, Stem Cell Institute of America and Physician Business Solutions generated millions of dollars in revenue by training and advising health care practitioners on how to add stem cell therapy to their practices. Superior healthcare allegedly generated revenues by selling these products directly to consumers and by contracting with clinics throughout the state to administer injections in exchange for a fee. Patients receive more than one injection for these therapies, which cost $5,000 per injection.
The complaint shows that the way in which medicine propaganda was rolled into one convenient package for chiropractors was creative. The complaint states that promotional material was used to lure chiropractors to join the scheme.
Stem cells help to rejuvenate the joints, allowing your adjustments to really take hold and the alignment process to occur. . .
Stem cell and regenerative therapies have recently shown incredible results with conditions that, up until now, were only treated with dangerous, unreliable surgeries or masked with pain drugs. But with these therapies, patients are experiencing seemingly miraculous outcomes. Chiropractors can be integrated with a [sic] MD or DO to offer these protocols in merely 60 days. Yet these therapies keep with the spirit of the chiropractic soul, i.e., avoiding allopathic health care, major surgery or pain drugs.
The way to help patients avoid allopathic health care and its attendant dangers is to team up with an allopathic doctor.
Civil penalties are doubled for violations committed against elderly or disabled persons under Georgia law, which is why the lawsuit is still pending.
The Georgia AG filed a suit against Elite Integrated Medical and other corporate and individual defendants in 2020 forjunctive relief, consumer restitution, and civil penalties. According to that complaint, Elite made over $6.4 million by using aggressive marketing techniques and high-pressure sales tactics to convince consumers, most of whom were elderly and/or disabled, to purchase expensive, unproven stem cell treatments that are not covered by Medicare or health insurance. The AG claims that.
Elite represents that it has a staff of medical doctors who provide its products to patients, when in fact, medical doctors administer a very limited number of product injections. The vast majority of patients interact only with chiropractors and nurse practitioners, and most of the injections are administered by nurse practitioners.
The suit is still pending in a Georgia state court.
The Washington State Attorney General filed a civil action last week against US Stemology and its owner for marketing stem cell therapies for COVID-19 and dozens of other serious medical conditions. The stem cell clinic was started out of the basement of her spa.
According to the complaint, the defendants charged patients as much as $10,000 to participate in the clinic's purported patient funded research and claimed they were treating patients as part of clinical trials. Two of the primary researchers listed on US Stemology's trials were also principals of the company that operated the IRB.
Per the AG's press release.
the trials themselves did not follow accepted standards of research. For example, the trials did not use a control group or a standard course of treatment for each patient, and relied solely on patient surveys to assess results. Typically, legitimate clinical trials pay patients — not charge them thousands of dollars — for agreeing to undergo experimental treatments.
The AG's office was first made aware of the clinic's false claims that it could prevent and treat COVID-19 by a concerned citizen. The clinic's stem cell therapies could not be used to treat dozens of other conditions because there was no reliable scientific evidence.
The lawsuit seeks to stop the clinic from making false and deceptive claims, as well as civil penalties which could be millions of dollars.
Unscrupulous practitioners and their associates will continue to abuse patients until there is a regulatory scheme in place. State consumer protection and false advertising laws can help deter stem cell shilllaws by vigorously pursuing them in court.
Stem cell therapy information can be found in The Niche blog, which is written by Paul Knoepfler, PhD, a stem cell scientist.
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