Study Finds ‘Urgent Need’ for Regulation of Stem Cell Industry

By Pat Anson, PNN Editor

Over 2,750 businesses and clinics in the U.S. are selling stem cell products – four times as many as in 2016 – most of them offering treatments for pain and orthopedic conditions that are not approved by the Food and Drug Administration, according to a new analysis.

The only stem cell products that are currently approved by the FDA are used to treat sickle cell disease and some cancers. Despite FDA threats to crackdown on “unproven” stem cell products, clinics have proliferated around the country, marketing stem cell therapies for chronic pain, arthritis and other medical conditions. California, Texas and Florida lead the nation with over 300 stem cell clinics in each state.

"One of the most troubling features of this marketplace is that businesses selling unproven and non-FDA-approved stem cell products often use marketing misrepresentations and aggressive sales tactics to exploit the hope, suffering, fear or desperation of patients," says lead author Leigh Turner, PhD, a professor of health, society and behavior at the University of California, Irvine.

Using Google Maps and other online search tools, Turner and his colleagues spent five years compiling data on stem cell businesses. Their findings are published online in the journal Cell Stem Cell.

Turner's analysis found that the most common types of stem cell treatments being offered were for pain (85%), orthopedic diseases and injuries (46%), and sports-related injuries (22%). Most companies did not disclose on their websites how much their therapies cost, but of those that do, the average price was $5,118. Stem cell injections and infusions are usually not covered by insurance.

"Many of these 'clinics' are promoting unlicensed and unproven stem cell products and claim their interventions do not require FDA approval," Turner said. "However, that couldn't be further from the truth. I found that there is widespread promotion of products that do, in fact, require premarketing authorization by the FDA. In many cases, these clinics are using misleading advertising and predatory marketing techniques."

Most stem cell businesses offer “autologous” stem cell products derived from a patient’s own body tissue – such as fat or bone marrow -- which the companies don’t consider a “drug” that falls under FDA jurisdiction.

The FDA has been slow to take action against unlicensed stem cell operators, due in part to a grace period the agency adopted in 2017 to give them more time to submit new drug applications for FDA review. That grace period recently ended, with no indication that many stem cell providers took the agency up on its offer.      

Turner acknowledges there have been “some encouraging results” from studies on stem cell treatments for osteoarthritis and orthopedic conditions, but said there was not enough research yet to justify commercializing them. He worries the stem cell industry has grown so quickly that the FDA can’t provide adequate regulation without substantial increases in enforcement activity.

“There is an urgent need for better oversight of this marketplace. Regrettably, marketing claims by some businesses also question the legitimacy and trustworthiness of regulatory bodies,” he wrote.

Turner’s research was funded by The Pew Charitable Trusts, which released its own report in June that was highly critical of the stem cell industry. Like the Pew report, Turner cites cases where patients suffered injuries after receiving unapproved stem cell treatments, without pointing out that the number pales in comparison to over 250,000 Americans who die every year from medical errors linked to “proven” treatments.   

FTC Warns CBD Companies About False Health Claims

By Pat Anson, PNN Editor

The U.S. Federal Trade Commission is once again going after companies that make unsubstantiated claims about the health benefits of cannabidiol (CBD) products. The crackdown, called “Operation CBDeceit,” is part of the agency’s ongoing effort to protect consumers from misleading advertising.

The FTC announced that six sellers of CBD oils, topical creams, gummies, lozenges and other products have signed administrative settlements agreeing not to make any further deceptive claims that CBD can treat pain, migraines, arthritis, cancer, heart disease and other health conditions.

“These CBD sellers lacked the scientific proof to back up their extreme claims. In fact, they often didn’t have any proof at all. But that didn’t stop them from saying these benefits were clinically proven. In truth, CBD is not a magical cure-all and there is no competent and reliable scientific evidence for these kinds of over-the-top health claims,” said Andrew Smith, Director of the FTC Bureau of Consumer Protection.

The FTC complaint against Utah-based Bionatrol Health alleged the company claimed its CBD products treat pain better than prescription medications like OxyContin. The company also allegedly deceived customers who ordered one bottle of its CBD oil by changing the order to five bottles without their consent.

The proposed settlement requires Bionatrol to pay $20,000 to the FTC and to notify customers about the FTC order. Similar settlements were reached with the other five companies.

This isn’t the first time the FTC and other federal agencies have gone after sellers of CBD, kratom and other dietary settlements for making unsubstantiated health claims.

The enforcement actions are sporadic and usually only target small companies. Sometimes a warning letter is as far as it goes and the company makes only a minor change in its marketing claims.

FTC IMAGE

In March 2019, for example, the FTC and Food and Drug Administration sent a warning letter to Nutra Pure, telling the company its hemp and CBD oils were unapproved drugs under federal law and “may not be legally introduced or delivered for introduction into interstate commerce.”

Nearly two years later, the company is still selling hemp and CBD oils, and has a disclaimer on its CBDPure website stating that its products “are not intended to diagnose, prevent, treat, or cure any disease.”

But when this reporter posed as a customer in an online chat with “Catherine,” a CBDPure representative, we were assured that CBD can treat pain and other health conditions.  

Customer: “Hi I'm wondering if you can recommend a CBD product for arthritis pain.”

Catherine: “Our oils are 300, 600 or 1000 mg CBD in full spectrum hemp oil. People with a mild condition or just looking to improve health start with the 300mg or 600mg. People with more severe or chronic conditions typically purchase the 1000 mg CBDPure hemp oil or 750 mg CBDPure soft gel.” 

Customer: “Will they help with pain and other health conditions?” 

Catherine: “Yes. There are numerous studies showing CBD has the ability to provide therapeutic benefits in the treatment of various conditions, including chronic pain, arthritis, anxiety/depression, nausea, epilepsy, insomnia and sleep issues, fibromyalgia, glaucoma and many other ailments.” 

Customer: “That's interesting. I have a friend with fibromyalgia. Is there something that can help her?” 

Catherine: “Yes. Same deal. Ideally, you start off with a lower mg dose and increase the amount you take weekly until you find what works for your body chemistry.” 

Customer: “And it'll eventually make the pain go away once you find the right dose?” 

Catherine: “Yes. It really depends on how your body tolerates and adapts to these dietary supplements.”

FTC officials say false claims about the therapeutic benefits of CBD and other supplements create a “real potential for serious harm to consumers health and safety.” But in a briefing with reporters announcing the six settlements reached in Operation CBDeceit, they acknowledged their investigation did not find any evidence about customers being harmed by the companies’ products.

“We’re not here saying CBD products are dangerous or that CBD products can’t offer benefits. Just that if you’re going to tout health benefits of your products, those claims have to be truthful and they have to be substantiated by the science,” said Smith.

GlaxoSmithKline Most Heavily Fined Drug Company

By Pat Anson, PNN Editor

The pharmaceutical industry has long been criticized for engaging in illegal or unethical activities, such as fraud, kickbacks and price gouging. A new study published in JAMA shines a light on the scale of the problem, finding that Big Pharma paid over $30 billion in financial penalties for illegal activities in the United States.

Researchers looked at state and federal settlements from 2003 to 2016 and found that almost every large pharmaceutical company had paid a fine for illegal activity. The biggest transgressor was GlaxoSmithKline (GSK), which paid nearly $9.8 billion to settle 27 cases brought against it for bribery, corruption, improper marketing, pricing violations and selling adulterated drugs. In one settlement alone, GSK was fined $3 billion for encouraging doctors to prescribe its antidepressants to children.  

The fines paid by GSK were over three times higher than the amounts paid by Pfizer ($2.9 billion) and Johnson & Johnson ($2.6 billion) during the study period. Researchers say only four of the 26 drug companies they analyzed were not assessed a penalty.

TOP 10 MOST HEAVILY FINED DRUG COMPANIES

1. GlaxoSmithKline $9.8 billion

2. Pfizer $2.9 billion

3. Johnson & Johnson $2.6 billion

4. Abbott Laboratories $2.5 billion

5. Merck $2.1 billion

6. Eli Lilly $1.8 billion

7. Schering-Plough $1.6 billion

8. Wyeth $1.6 billion

9. Bristol Myers Squibb $1.4 billion

10. Novartis $1.2 billion

“Among the large pharmaceutical companies included in this study, 85% had evidence of financial penalties for illegal activities. Given the scope and nature of the illegal activities involving financial penalties, physicians and regulators should exhibit vigilance over the activities of large pharmaceutical firms,” wrote lead author Denis Arnold, PhD, a professor of business ethics at Belk College of Business, University of North Caroline at Charlotte.

“Four firms were not found to have penalties for illegal activities during the sample period. This may indicate an ability for illegal activity to be undetected, although these firms may instead have effective ethics and compliance programs.”

Because the study period ended in 2016, it did not include any recent settlements with drug companies involving opioid litigation. Nor did it cover fines paid outside the U.S., such as the $490 million fine that GSK paid for bribing Chinese doctors to prescribe its medications.

“This has been a deeply disappointing matter for GSK," chief executive Sir Andrew Witty said in a formal apology to the Chinese government in 2014.

Not much has changed at GSK over the years. This year the company agreed to pay $4.5 million in fines in Australia for marketing and price violations involving the pain relief gel Voltaren.  The British pharmaceutical giant was also recently fined $2.8 million by Romania for failing to supply the country with asthma medication.

Drug company executives rarely serve prison time for illegal activities and the large fines do not appear to be much of a deterrent against unethical behavior. The nearly $9.8 billion paid by GSK amounts to less than 2 percent of its total revenues during the study period. On average, GSK’s illegal activities went on for over seven years before the company stopped them, according to the JAMA study.

GSK did not respond to a request for comment for this story.    

Fraud Alert for Speaker Programs

In recent years, federal watchdogs have become increasingly concerned about the use of speaker fees, free meals, entertainment and other kickbacks paid by healthcare companies to promote their drugs and medical devices. In the last three years, companies paid nearly $2 billion to healthcare providers for speaker-related services.

In a special fraud alert released this week, the Office of Inspector General (OIG) for the Department of Health and Human Services warned against the practice, saying high-priced speaker programs “may be subject to increased scrutiny.” The OIG cited cases where speaker programs were held at wineries, stadiums and restaurants where expensive meals and alcohol were served at no charge to attendees.

“OIG is skeptical about the educational value of such programs. Our investigations have revealed that, often, HCPs (healthcare providers) receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend,” the report warns.

“Furthermore, studies have shown that HCPs who receive remuneration from a company are more likely to prescribe or order that company’s products. This remuneration to HCPs may skew their clinical decision making in favor of their own and the company’s financial interests, rather than the patient’s best interests.”