medical ethics
We have discussed the Miracle Mineral Solution (MMS) before. Now it has been making headlines again. It has been reported that a Miami federal jury convicted a father and his three sons of selling a toxic bleach solution as a “miracle” medical cure out of a fake Florida church’s website to thousands of consumers across the US. Mark Grenon, 65, and sons Jonathan, 37, Joseph, 35, and Jordan, 29, chose to represent themselves in their two-day trial in Miami federal court. But they said nothing during the trial as if they were silently protesting the proceeding. Only after the 12-person jury hit them with a quick verdict did one of the Grenons speak up. “We will be appealing,” Joseph Grenon said.
During the trial and closing arguments, prosecutors portrayed the four defendants as con men who used a phony religious front on a website, the Genesis II Church of Health and Healing, to sell $1 million worth of their “Miracle Mineral Solution” a cure for 95% of the world’s known diseases, from AIDS to the coronavirus. “This whole Miracle Mineral Solution scheme was built on deception and dishonesty,” the prosecutor said during his closing argument, telling jurors that the Grenons “created a fake church to make it harder for the Food and Drug Administration and government to stop them from selling snake oil.” But, “this was no church,” he argued. “This was a scam for money — an old-fashioned scam.” The jury found the four defendants — all wearing beige inmate uniforms, ponytails, and flowing beards — guilty of conspiring to defraud the U.S. government and FDA, which regulates the food and drug industry, by distributing an unapproved and misbranded drug, Miracle Mineral Solution (MMS). That conviction carries up to five years in prison.
During the trial, the prosecutor said the Grenons called themselves “bishops” and peddled MMS as “sacraments” to consumers in South Florida and other parts of the US in exchange for a “donation” to the Genesis church, before the FDA cracked down on the family in 2020.
The Grenons were charged that April with conspiring to defraud the U.S. government after the outbreak of the COVID-19 pandemic when they defied FDA and court orders to stop distributing the toxic MMS substance. Their criminal case was the first pandemic-related enforcement action in Florida. In public warnings, FDA said it received several reports of hospitalizations and life-threatening conditions as people drank the dangerous substance.
MMS is a chemical solution containing sodium chlorite that, when mixed with water and a citric acid “activator,” turns into chlorine dioxide, a powerful bleach typically used for industrial water treatment or bleaching textiles, pulp, and paper. During the trial, a FDA agent testified about three Grenon-produced videos that pitched the solution as a cure for cancer, lung cancer, and COVID-19, among other deadly diseases. “We are trying to create a world without disease,” Mark Grenon said in one video, pitching the MMS substance. “It’s been proven to be tremendously effective in curing cancer.” Another video, dated March 8, 2020, was titled: “The coronavirus is curable. Do you believe it? You better!”
Prosecutors said the Grenon family’s religious front, the Genesis II Church of Health and Healing, sold tens of thousands of MMS orders in violation of federal law since 2010. It was in that year that Mark Grenon claims to have founded the organization with a man named Jim Humble in a plan to avoid governmental regulation and arrest as they promoted MMS as a miracle cure. Humble, a man who has dabbled in Scientology and professed to be a billion-year-old god, began promoting the substance as early as 2006 in self-published works after he claimed to have discovered its medical properties while on a gold-mining expedition in South America. After Humble supposedly stepped away from the organization in 2017, Grenon continued to manufacture, promote and sell MMS with his three sons.
The Grenons’ open defiance of a court order ultimately led to criminal charges and a federal raid on the family’s Bradenton home, where federal investigators say they found loaded guns, nearly 10,000 pounds of sodium chlorite powder, and thousands of bottles of MMS.
The World Federation of Chiropractic (WFC) has recently launched a new Global Patient Safety (GPS) initiative:
Unanimously approved by the WFC Board at its May meeting, the project will be overseen by the Research Committee and involve the establishment of an expert task force. Planned projects will include a scoping review, identification of best practices in incident reporting and learning, risk management in chiropractic practice and knowledge translation activities.
In recent years, patient safety has increasingly been in the spotlight as health systems strive to reduce unnecessary incidents and iatrogenic injury.
“With adverse events having the potential to impact trust and confidence in the chiropractic profession, it is important that we do as much as possible to inform ourselves in relation to the risks and benefits of chiropractic treatments and related activities,” said Prof. Richard Brown DC, LL.M, WFC Secretary- General.
“While we know that serious adverse events are rare, patients with multiple co-morbidities and known risk factors require special attention. The WFC GPS Task Force will highlight key areas of patient safety to support chiropractors, build and strengthen the existing safety culture and help to meet the expectations of patients and the public.”
Chiropractors use a package of interventions in their treatment of patients, including hands-on care, adjunct therapies, health promotion, advice and exercise prescription. The process of shared decision-making involves consideration by the chiropractor of the suitability and safety of each intervention. In addition to direct patient care, chiropractors also have a duty to consider the safety of their offices and clinics.
A WHO resolution on patient safety, passed in 2019 at the World Health Assembly, made a commitment to take global action in tackling avoidable harm.
Its subsequent publication, Global Action on Patient Safety, set out goals and targets to reduce morbidity from healthcare related incidents.
Chair of the Task Force and Research Committee vice-chair, Dr Katie Pohlman DC, PhD, said: “With the current global focus on patient safety, I’m proud to be leading this WFC Task Force, which will support the chiropractic profession but, most importantly, work to minimize adverse events and protect patients.
“The creation of an open, transparent culture of patient safety is key to maintaining trust and credibility. The Task Force is looking forward to adding to the body of knowledge and advancing safe, evidence-based, people-centered practice.”
The WFC GPS Task Force will report to Research Committee Chair, Assoc. Prof Sidney Rubinstein. It will include members of the existing Research Committee as well as external experts.
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At first, most people will think: WHAT A GOOD IDEA!
After a bit of reflection, however, some might ponder: WHY ONLY NOW AND NOT DECADES AGO?
And after reading the above text carefully, skeptics might feel that the exercise can already be classified as a PR gimmick that will not generate the needed information:
- The WFC has yet again failed to establish a monitoring system of adverse effects; without it ‘patient safety’ is not achievable.
- They claim that “we know that serious adverse events are rare”. How do they know this? And if they already are convinced of this, the new task force is bound to be a pure ‘white wash’.
- They think an “existing safety culture” exists in chiropractic. This is wishful thinking and far from reality.
- They speak of the “expectations of patients and the public” but ignore the need for a monitoring system accessible to the public.
We have discussed the currently fashionable herbal remedy, ‘kratom‘, before:
Inadequate regulation of Kratom supplements put consumers at risk
News about Kratom: the herb was recently (semi-)legalized in Thailand
Kratom: a ‘herbal drug’ with the potental to do more harm than good
A quick recap:
Kratom is made of the leaves of Mitragyna speciosa, a tree endogenous to parts of Southeast Asia. It has been used traditionally for its stimulant, mood-elevating, and analgesic effects. The plant’s active constituents, mitragynine and 7-hydroxymitragynine, have been shown to modulate opioid receptors, acting as partial agonists at mu-opioid receptors and competitive antagonists at kappa- and delta-opioid receptors. Both alkaloids are G protein-biased agonists of the mu-opioid receptor and therefore, may induce less respiratory depression than classical opioid agonists. The Mitragyna alkaloids also appear to exert diverse activities at other brain receptors (including adrenergic, serotonergic, and dopaminergic receptors), which may explain the complex pharmacological profile of raw kratom extracts. By the early 2000s, kratom was increasingly used in the US as a substitute for prescription and illicit opioids for managing pain and opioid withdrawal by people seeking abstinence from opioids. There are numerous assessments where people have been unable to stop using kratom and withdrawal signs and symptoms are problematic. Kratom does not appear in normal drug screens and, when taken with other substances of abuse, may not be recognized.
Now it has been reported that the family of a Florida woman who died in 2021 after ingesting kratom has been awarded more than $11m from a distributor of the herbal extract. “There is of course no amount of money that will make up for the pain and suffering that Ms Talavera’s children are enduring because of their mother’s death,” Middlebrooks wrote in court records addressing the sanction against Kratom Distro. “The law nonetheless recognizes that the defendant must pay something, however inadequate.”
The US Drug Enforcement Agency in 2016 had imposed its strictest restrictions on kratom, which is made from the leaves of an evergreen tree and is often used by people to self-treat pain, anxiety, depression, and opioid addiction as well as withdrawal. There was an intense, immediate public backlash to that approach, however, and it prompted the DEA to rescind its prohibition of kratom, which is sold in stores and online.
The US Food and Drug Administration nonetheless has warned consumers over possible safety and addiction risks associated with kratom, and it has spoken in favor of more research aimed at gaining a better understanding of “the substance and its components”.
Friends of Talavera, a resident of the Florida community of Boynton Beach, introduced her to kratom years before her death. Her family said she regarded it as a safe, natural supplement and had taken some after buying it online from the Kratom Distro when her partner and the father of her youngest child – Biagio Vultaggio – found her unconscious in the living room on 20 June 2021. The 39-year-old Talavera was face down on the ground next to an open bag of a kratom derivative marketed as a “space dust”, her family has said. Vultaggio called paramedics, and they took Talavera to a hospital where she was pronounced dead. An autopsy later listed Talavera’s cause of death as acute intoxication from mitragynine, the main kratom component. The local coroner wrote in a report that “at high concentrations, mitragynine produces opioid-like effects, such as respiratory failure”.
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Kratom Disro claims that 
Product Consistency
- Our kratom powder is sourced directly from Indonesia monthly. Your order was literally on a farm in Indonesia two months ago. No old powder.
- Our kratom extracts are produced in the US by a licensed chemist and a professionally trained staff.
- We only use delicious flavors and quality ingredients.
Complete Transparency
- Every batch of products we receive is lab tested and will not ship out without meeting our meticulous quality standards.
- Current labs – We will never show you an out-of-date lab with our products.
- Guaranteed purity levels and free of all toxins.
Get It When You Want It
- Many orders shipped same day.
- USPS shipping on all orders under 6 pounds.
- Larger orders can ship USPS Priority for a small additional charge.
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Back to the above lawsuit:
One of the attorneys for Talavera’s family, Tamara Williams, said in a statement that the judgment won by her clients “should be a wakeup call to the kratom industry”. Williams’s law firm had also recently won a $2.5m jury verdict against a kratom manufacturer in Washington state after a separate lawsuit alleging wrongful death. A colleague of Williams called on government officials to take steps “to protect other families from having to deal with unnecessary kratom overdose deaths”.
Sobrenix (Kudzu, Milk Thistle, B Vitamins & More) is “designed to reduce alcohol cravings and help you detoxify your body so you can successfully manage alcohol consumption. Even better, taken before drinking, Sobrenix’s ingredients help you stop before you’ve had too much. DETOXIFY YOUR BODY with a powerful formula that combines herbs and nutrients that support liver health, curb cravings, and help you wake up without a nasty hangover. Sobrenix kick-starts the detoxification process with essential herbs like Milk Thistle and Chanca Piedra. Additionally, the formula contains the critical B-Vitamins that alcohol washes away so you can wake up happy and healthy again!”
Yes, you suspected correctly: this is pure BS!
Not only that but the Federal Trade Commission is taking action under the FTC Act and the Opioid Addiction Recovery Fraud Prevention Act of 2018 (OARFPA) against the makers of Sobrenix. According to the FTC’s complaint, the makers, a company, Rejuvica, and its owners, Kyle Armstrong and Kyle Dilger, made numerous unsubstantiated and false claims about Sobrenix and used paid endorsers in deceptively formatted advertising. The defendants also used bogus review sites to deceive consumers about their products.
As a result of the FTC’s suit, the defendants have agreed to a proposed court order that would permanently ban them from making any unsubstantiated claims about healthcare products or services, as well as require them to pay $650,000 to the FTC to be used for providing refunds to consumers.
“We will not tire in our pursuit of those who prey on individuals struggling with alcohol or other substance use disorders,” said Samuel Levine, Director of the Bureau of Consumer Protection. “This case evidences the breadth of the FTC’s authority to pursue such wrongdoing under both the FTC Act and OARFPA.”
The FTC charges that the defendants marketed Sobrenix with messages like:
- “STRUGGLING TO CONTROL YOUR ALCOHOL CONSUMPTION? Sobrenix is designed to reduce alcohol cravings and help you detoxify your body so you can successfully manage alcohol consumption. Even better, taken before drinking, Sobrenix’s ingredients help you stop before you’ve had too much.”
The FTC charges that Rejuvica and its owners lacked adequate evidence to support these claims. The complaint charges that Rejuvica, Armstrong, and Dilger violated both the FTC Act and OARFPA. The proposed order contains a total monetary judgment of $3,247,737, which is partially suspended based on the defendants’ inability to pay the full amount. The defendants will be required to pay $650,000 to the FTC to be used to refund consumers. If the defendants are found to have lied to the FTC about their financial status, the full judgment will be immediately due.
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A few short comments might be in order:
- Regulators have the duty to protect consumers from false health claims.
- It is commendable that some authorities sometimes do their duty and go after some of the people responsible for making false claims related to dietary supplements.
- Such actions should, however, occur MUCH more often.
- They ought to happen also in countries other than the US.
- Similar actions should be initiated against ALL false claims made for healthcare products and services.
- This means that all practitioners of so-called alternative medicine (SCAM) would need to review their advertising, websites, etc., and erase therapeutic claims that are not supported by evidence.
- This would unquestionably amount to an enormously valuable service to public health.
- Most countries already have legislation that would make such steps possible; my question, therefore, is this:
WHY ARE CONSUMERS NOT ADEQUATELY PROTECTED BY THEIR NATIONAL REGULATORS FROM CHARLATANS WHO SELL INEFFECTIVE AND OFTEN DANGEROUS SCAMs AT HIGH COSTS?
The website of the World Federation of Chiropractic (WFC) points out that public health is defined by the WHO as follows:
“Activities to strengthen public health capacities and service aim to provide conditions under which people can maintain to be healthy, improve their health and wellbeing, or prevent the deterioration of their health. Public health focuses on the entire spectrum of health and wellbeing, not only the eradication of particular diseases.”
The WFC then continues stating this:
As primary contact health professionals, chiropractors can play an important role as public health advocates. This can range from providing support and advice on health matters such as physical activity, diet, and fitness as well as lifestyle choices such as injury prevention and avoiding tobacco use. Chiropractors can also play a role in counselling patients and communities on the benefits of public health measures, especially as this relates to immediate health needs of each region.
I think that this might merit a few comments.
- Physical activity is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
- Diet is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
- Fitness is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
- Lifestyle choice is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
- Injury prevention is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
- Avoiding tobacco use is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
- Counseling is undoubtedly an important issue for public health; however, there are clearly healthcare professionals who are in a better-informed position to advise on it than chiropractors.
So, what is the real contribution of chiropractors to public health?
- Chiropractors tend to advise their clients against vaccinations.
- Some mislead the public by claiming they boost immunity and prevent serious infections.
- Many undermine evidence-based medicine by promoting obsolete myths such as ‘the innate’ or subluxations.
- Many sell supplements that could interact with prescription drugs.
- Many make bogus health claims for profit.
I would therefore argue that, on balance, the contribution of chiropractors to public health might be considerable …
sadly, however, it goes in the wrong direction.
As the organizer of several demos in the area of Linz, Austria, a ‘corona activist’ and ‘Holocaust denier’ had repeatedly made headlines over the past two years. Now the 39-year-old Austrian man is in the headlines yet again.
It has been reported that, on the evening of July 23, he was stopped by the police for a routine traffic control. His three children, aged 15, 11, and 5, were also in the car. “I know I’m wanted. I don’t have a driver’s license and I have a dead body in the trunk,” he said as he got out of the car. As the officers soon realized, he was only partly joking. A legal case for Holocaust denial was pending against the man who had not appeared at his main hearing last August, so a search was underway for him.
When police officers checked the car, they made the horrifying discovery. In the trunk was a woman’s body, wrapped in sheets. The dead woman turned out to be the wife, aged 38, of the driver. According to preliminary findings, she had died 4 hours earlier. Apparently, she had suffered from incurable cancer, and the police suspect that the illness had not been treated – her husband did not just not believe in vaccinations but disliked all drugs.
The husband, who already had several previous convictions, claimed that he was on his way to bury his wife somewhere “in nature”. The 39-year-old man was arrested and is now in pre-trial detention – though not for the incident with his wife’s body, but for Holocaust denial. He is said to have compared the Corona measures to the Holocaust, and the arrest order was issued because he failed to appear for his trial.
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One does not need to be a clairvoyant to predict that this remarkable man will come up with more surprises. I wonder what he might think of next.
Like ultra-processed food (UPF) itself, the subject of UPF is everywhere – radio, TV, Twitter, you name it, the topic crops up. I too could not resist writing a post on it a few months ago. And now I am publishing another one but one in a slightly more irritated mood.
Why do these endless discussions on UPF irritate me?
To start with, there is no uniform definition of UPF, and many commentators seem more than a little confused about what UPF actually is. One definition holds that Ultra-processed foods are foods that have been altered to include fats, starches, sugars, salts and hydrogenated oils extracted from other foods. They contain ingredients, additives, and preservatives that are not normally used in home cooking. It seems obvious that discussions on UPF without a clear and understandable definition of the term are merely generating confusion in the general public.
But there are, of course, lists of UPF that might render the subject a bit clearer. The trouble, however, is that these lists reveal disagreement among each other. Thus they are prone to generate even more confusion.
Next, there is the evidence – and there is lots of it. It suggests that the regular consumption of UPF is bad for virtually every aspect of health. And if there is no evidence that it is detrimental for a given condition, it probably is merely because nobody has yet bothered to do the analyses. The trouble is, however, that all the relevant research comes from either basic science or epidemiology. This means that causality is unproven.
A further problem is that even the experts don’t know what the alleged causal factors in UPF are.
- Is it the processing?
- The additives?
- The sugar?
- The fats?
- If so, which fats exactly?
- Is it perhaps a complex inter-play of some of these factors?
If we want to make progress, we need to know! If not, we cannot possibly begin to avoid the health-threatening effects of UPF.
The final and arguably biggest problem is that UPF is everywhere. Nobody living in an industrialized country and earning a regular living can avoid consuming UPF. This means, I fear, that all the current hype about UPF is not just irritating but possibly counter-productive.
Imagine an average person trying to make sense of these discussions. She would soon give up and conclude that all these ‘clever’ experts know nothing at all. Her foremost concern is to make ends meet. In the end, she will carry on as before. Alternatively, she might even conclude that, as the even experts do not make sense, UPF cannot be all that bad after all.
After reading about and listening to the arguments around UPF, I ask myself this: would it not be more productive to apply more common sense and focus on a few nutritional messages that are 1) solidly based on evidence and 2) an average person can actually follow?
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus (DM) that can cause annoying symptoms. To address this condition, several treatment approaches have been proposed, including static magnetic field (SMF) therapy, which has shown promise in treating neurological conditions. Therefore, this study aimed to investigate the effects of SMF therapy on symptomatic DPN and the quality of life (QoL) in patients with type 2 diabetes.
A double-blind, randomized, placebo-controlled trial was conducted from April to October 2021. Sixty-four DPN patients (20 males, 44 females) were recruited for the study via invitation. The participants were divided into two groups: the magnet group, which used magnetic ankle bracelets (155 mT) for 12 weeks, and the sham group, which used non-magnetic ankle bracelets for the same duration. Neuropathy Symptom Score (NSS), Neuropathic Disability Score (NDS), and Visual Analogue Scale (VAS) were used to assess neuropathy symptoms and pain. In addition, the Neuropathy Specific Quality of Life Questionnaire (Neuro-QoL) tool was used to measure the patients’ quality of life.
Before treatment, there were no significant differences between the magnet and sham groups in terms of the NSS scores (P = 0.50), NDS scores (P = 0.74), VAS scores (P = 0.17), and Neuro-QoL scores (P = 0.82). However, after 12 weeks of treatment, the SMF exposure group showed a significant reduction in NSS scores (P < 0.001), NDS scores (P < 0.001), VAS scores (P < 0.001), and Neuro-QoL scores (P < 0.001) compared to the baseline. The changes in the sham group, on the other hand, were not significant.
The authors concluded that according to obtained data, SMF therapy is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL in diabetic type-2 patients.
Our own study and systematic review of the effects of magnetic bracelets and similar devices suggested that the effects of such treatments are due to placebo responses. Therefore, I find the findings of this new study most surprising. Not only that, to be honest, I also find them suspect. Apart from the fact that the treatment has no biological plausibility, I have three main reasons for my skepticism.
- The authors stated that there was no distinguishable difference between the sham and SMF devices in terms of their appearance, weight, or texture, which helped to ensure that the study was double-blinded. This is nonsense, I am afraid! The verum device is magnetic and the sham device is not. It is hardly conceivable that patients who handle such devices for any length of time do not discover this simple fact and thus de-blind themselves. In turn, this means that a placebo effect can easily explain the outcomes.
- Authors who feel that their tiny study of a highly implausible therapy lends itself to concluding that their therapy ‘is recommended as an easy-to-use and drug-free method for reducing DPN symptoms and improving QoL’ can, in my view, not be taken seriously.
- Something that always makes me suspicious of clinical trials is a lack of a placebo response where one would normally expect one. In this study, the control group exhibits hardly any placebo response. Wearing a strap around your ankle that allegedly emits therapeutic radiation would result in quite a strong placebo effect, according to our own findings.
So, forgive me if I do not trust this study any further than I can throw it! And pardon me if I still think that our previous conclusion is correct: The evidence does not support the use of static magnets for pain relief, and therefore magnets cannot be recommended as an effective treatment.
I don’t usually find reading medical papers scary. An article in the prestigious journal ‘Nature’ is the exception. Here is its abstract:
Long COVID is the patient-coined term for the disease entity whereby persistent symptoms ensue in a significant proportion of those who have had COVID-19, whether asymptomatic, mild or severe. Estimated numbers vary but the assumption is that, of all those who had COVID-19 globally, at least 10% have long COVID. The disease burden spans from mild symptoms to profound disability, the scale making this a huge, new health-care challenge. Long COVID will likely be stratified into several more or less discrete entities with potentially distinct pathogenic pathways. The evolving symptom list is extensive, multi-organ, multisystem and relapsing–remitting, including fatigue, breathlessness, neurocognitive effects and dysautonomia. A range of radiological abnormalities in the olfactory bulb, brain, heart, lung and other sites have been observed in individuals with long COVID. Some body sites indicate the presence of microclots; these and other blood markers of hypercoagulation implicate a likely role of endothelial activation and clotting abnormalities. Diverse auto-antibody (AAB) specificities have been found, as yet without a clear consensus or correlation with symptom clusters. There is support for a role of persistent SARS-CoV-2 reservoirs and/or an effect of Epstein–Barr virus reactivation, and evidence from immune subset changes for broad immune perturbation. Thus, the current picture is one of convergence towards a map of an immunopathogenic aetiology of long COVID, though as yet with insufficient data for a mechanistic synthesis or to fully inform therapeutic pathways.
The paper ends with this gloomy statement: “The oncoming burden of long COVID faced by patients, health-care providers, governments and economies is so large as to be unfathomable, which is possibly why minimal high-level planning is currently allocated to it. If 10% of acute infections lead to persistent symptoms, it could be predicted that ~400 million individuals globally are in need of support for long COVID. The biggest unknowns remain the joined-up scheme of its pathogenesis and thus the best candidate therapeutics to be trialled in randomized controlled trials, along with a better understanding of the kinetics of recovery and the factors influencing this. Some countries have invested in first-round funding for the pilot investigations. From the above, far more will be needed.”
In the context of this blog, we must, of course, ask: HAS SO-CALLED ALTERNATIVE MEDICINE (SCAM) SOMETHING TO OFFER?
I’m afraid that the short answer to this question is No!
However, one does not need to be a clairvoyant to predict that lots of therapeutic claims followed by plenty of methodologically weak (to put it politely) research will emerge from SCAM. Already some time ago, this homeopath indicated, that SCAM providers should see COVID as an opportunity: For homeopathy, shunned during its 200 years of existence by conventional medicine, this outbreak is a key opportunity to show potentially the contribution it can make in treating COVID-19 patients.
We should not hold our breath to see the emergence of convincing evidence, but we must be prepared to warn the public from getting exploited by charlatans.
The U.S. Department of Health and Human Services alleges that Jason James of the James Healthcare & Associates clinic in Iowa, USA — along with his wife, Deanna James, the clinic’s co-owner and office manager — filed dozens of claims with Medicare for a disposable acupuncture device, which is not covered by Medicare, as if it were a surgically implanted device for which Medicare can be billed. According to the lawsuit, more than 180 such claims were filed. Beginning in 2016, the lawsuit alleges, the clinic began offering an electro-acupuncture device referred to as a “P-Stim.” When used as designed, the P-Stim device is affixed behind a patient’s ear using an adhesive. The device delivers intermittent electrical pulses through a single-use, battery-powered attachment for several days until the battery runs out and the device is thrown away.
Because Medicare does not reimburse medical providers for the use of such devices, DHHS alleges that some doctors and clinics have billed Medicare for the P-Stim device using a code number that only applies to a surgically implanted neurostimulator. The use of an actual neurostimulator is reimbursed by Medicare at approximately $6,000 per claim, while P-Stim devices were purchased by the Keokuk clinic for just $667, DHHS alleges. The department alleges James knew his billings were fraudulent as the P-Stim device is “nowhere close to even resembling genuine implantable neurostimulators” and does not require surgery.
The lawsuit alleges that on June 15, 2016, when Jason James was contemplating the use of P-Stim devices at the Keokuk clinic, he sent a text message to P-Stim sales representative Mark Kaiser, asking, “Is there a limit on how many Neurostims can be done on one day? Don’t wanna do so many that gives Medicare a red flag on first day. Thanks.” After realizing the “large profit windfall” that could result from the billing practice, DHHS’s lawsuit alleges, James “told Mark Kaiser not to mention the Medicare reimbursement rate to his nurse practitioner or staff – only his office manager and biller needed that information.” James then pressured clinic employees to heavily market the P-Stim devices to patients, even if those patients were not agreeable or, after trying it, were reluctant to continue the treatment, the lawsuit claims.
In October 2016, the clinic’s supplier of P-Stim devices sent the clinic an email stating the company had “no position on what the proper coding might be for this device if billed to a third-party payer” such as an insurer or Medicare, according to the lawsuit. The company advised the clinic to “consult a certified biller/coder and/or attorney to ensure compliance.” According to the lawsuit, James then sent Kaiser a text message asking, “Should we be concerned?”
DHHS alleges the clinic’s initial reimbursement claims were submitted to Medicare through a nurse practitioner and were denied for payment due to the lack of a trained physician’s involvement. In response, the clinic hired Dr. Robert Schneider, an Iowa-licensed physician, to work at the clinic for the sole purpose of enabling James Healthcare & Associates to bill Medicare for the P-Stim devices, the lawsuit claims. James then informed Kaiser he had a goal of billing Medicare for 20 devices per month, which would generate roughly $125,573 of monthly income, the lawsuit alleges. The lawsuit also alleges Dr. Schneider rarely saw clinic patients in person, consulting with them instead through Facebook Live.
In April 2017, Medicare allegedly initiated a review of the clinic’s medical records, triggering additional communications between James and Kaiser. At one point, James allegedly wrote to Kaiser and said he had figured out why Medicare was auditing the clinic. “Anything over $7,500 is automatically audited for my area,” he wrote, according to the lawsuit. “We are now charging $7,450 to remove the audit.”
The clinic ultimately submitted 188 false claims to Medicare seeking reimbursement for the P-Stim devices, DHHS alleges, with Medicare paying out $4,100 and $6,300 per claim, for a total loss of $1,028,800. DHHS is suing the clinic under the federal False Claims Act and is seeking trebled damages of more than $3 million, plus a civil penalty of up to $4.2 million.
An attorney for the clinic, Michael Khouri, said Wednesday he believe the federal government’s lawsuit was filed in error because a settlement in the case had already been reached. However, the assistant U.S. attorney handling the case said no settlement in the case had been finalized and the lawsuit was not filed in error.
Previous legal cases
In 2015, the Iowa Board of Chiropractic charged Jason James with knowingly making fraudulent or untrue representations in connection with his practice, engaging in conduct that was harmful or detrimental to the public, and making untruthful statements in advertising. The board alleged James told patients they would be able to stop taking diabetes medication through the use of a diet and nutrition program, and that he had claimed to be providing extensive laboratory tests when not all of the tests for which he billed were ever conducted. The board also claimed James referred patients to a medical professional who was not licensed to practice in Iowa. The case was resolved with a settlement agreement in which James agreed to pay a $500 penalty and complete 10 hours of education in marketing and ethics.
In 2019, Schneider sued the clinic for failing to comply with the terms of his employment agreement. Court exhibits indicate the agreement stipulated that Schneider was to work no more than two days per month and would collect $2,000 for each day worked, plus $250 per month for consulting, plus “$250 per device over six per calendar month.” In March 2020, a jury ruled in favor of the clinic and found that it had not breached its employment agreement with Schneider.
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Before some chiropractors now claim that such cases represent just a few rotten apples in a big basket of essentially honest chiropractors, let me remind them of a few previous posts:
- A $2.6M Insurance Fraud by Chiropractors and Doctors?
- Fraud and sex offences by chiropractors
- Chiropractic therapy for gastrointestinal diseases. Evidence of scientific misconduct?
- Twenty Things Most Chiropractors Won’t Tell You
- The Dark Side of Chiropractic Care
- Chiropractic subluxation: the myth must be kept alive
- CHIROPRACTIC: an early and delightful critique
- Students of chiropractic condemn the ‘unacceptable behaviour’ of some chiropractors and their professional organisations
- Far too many chiropractors believe that vaccinations do not have a positive effect on public health
- Chiropractor is in the dock for not wearing a mask
- “The uncensored truth” about COVID-19 vaccines” … as told by some chiro loons
To put it bluntly: chiropractic was founded by a crook on a bunch of lies and unethical behavior, so it is hardly surprising that today the profession has a problem with ethics and honesty.
