MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

risk

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.

____________________________

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”.

________________________

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.

_________________________________

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”.

As we have recently discussed diet and its effects on health, it seems reasonable to ask whether there is a diet that is demonstrably healthy. A recent investigation attempted to answer this question.

This study was aimed at developing a healthy diet score that is associated with health outcomes and is globally applicable. It used data from the Prospective Urban Rural Epidemiology (PURE) study and tried to replicate it in five independent studies on a total of 245 000 people from 80 countries.

A healthy diet score was developed on the basis of the data from 147 642 people from the general population, from 21 countries in the PURE study. The consistency of the associations of the score with events was examined in five large independent studies from 70 countries.

The healthy diet score was developed based on six foods each of which has been associated with a significantly lower risk of mortality [i.e. fruit, vegetables, nuts, legumes, fish, and dairy (mainly whole-fat); range of scores, 0–6]. The main outcome measures were all-cause mortality and major cardiovascular events [cardiovascular disease (CVD)].

During a median follow-up of 9.3 years in PURE, compared with a diet score of ≤1 point, a diet score of ≥5 points was associated with a lower risk of:

  • mortality [hazard ratio (HR) 0.70; 95% confidence interval (CI) 0.63–0.77)],
  • CVD (HR 0.82; 0.75–0.91),
  • myocardial infarction (HR 0.86; 0.75–0.99),
  • stroke (HR 0.81; 0.71–0.93).

In three independent studies with vascular patients, similar results were found, with a higher diet score being associated with lower mortality (HR 0.73; 0.66–0.81), CVD (HR 0.79; 0.72–0.87), myocardial infarction (HR 0.85; 0.71–0.99), and a non-statistically significant lower risk of stroke (HR 0.87; 0.73–1.03). Additionally, in two case-control studies, a higher diet score was associated with lower first myocardial infarction [odds ratio (OR) 0.72; 0.65–0.80] and stroke (OR 0.57; 0.50–0.65). A higher diet score was associated with a significantly lower risk of death or CVD in regions with lower than with higher gross national incomes (P for heterogeneity <0.0001). The PURE score showed slightly stronger associations with death or CVD than several other common diet scores (P < 0.001 for each comparison).

Association of Prospective Urban Rural Epidemiology healthy diet score vs. Events in those with and without prior cardiovascular disease in the four independent prospective studies (n = 191 476). Hazard ratios (95%) are per 20 percentile increment in the diet score. Hazard ratios (95% CI) are multivariable adjusted.

The authors concluded that consumption of a diet comprised of higher amounts of fruits, vegetables, nuts, legumes, and a moderate amount of fish and whole-fat dairy is associated with a lower risk of CVD and mortality in all world regions, but especially in countries with lower income where consumption of these natural foods is low. Similar associations were found with the inclusion of meat or whole grain consumption in the diet score (in the ranges common in the six studies that we included). Our findings indicate that the risks of deaths and vascular events in adults globally are higher with inadequate intake of protective foods.

The authors rightly stress that their analyses have a number of limitations:

First, diet (as in most large epidemiologic studies) was self-reported and variations in reporting might lead to random errors that could dilute real associations between diet scores and clinical outcomes. Therefore, the beneficial effects of a healthier diet may be larger than estimated.

Second, the researchers did not examine the role of individual types of fruits and vegetables as components in the diet score, since the power to detect associations of the different types of fruits and vegetables vs. CVD or mortality is low (i.e. given that the number of events per type of fruit and vegetable was relatively low). Recent evidence suggests that bioactive compounds and, in particular, polyphenols which are found in certain fruit or vegetables (e.g. berries, spinach, and beans) may be especially protective against CVD.

Third, in observational studies, the possibility of residual confounding from unquantified or imprecise measurement of covariates cannot be ruled out—especially given that the differences in risk of clinical events are modest (∼10%–20% relative differences). Ideally, large randomized trials would be needed to clarify the clinical impact on events of a policy of proposing a dietary pattern in populations.

Fourth, the use of the median intake of each food component as a cut-off in the scoring scheme for each diet may not reflect the full range of consumption or provide a meaningful indicator of consumption associated with the disease. However, the use of quintiles instead of medians within each study or within each region yielded the same results indicating the robustness of our findings.

Fifth, the level of intake to meet the cut-off threshold for each food group in the diet score may differ between countries. However, in sensitivity analyses where region-specific median cut-offs were used to classify participants on each component of the diet score, the results were similar to using the overall cohort median of each food component. Further, with unprocessed red meat and whole grains included or excluded from the diet score in these sensitivity analyses, the results were again similar.

Sixth, misclassification of exposures cannot be ruled out as repeat measures of diet were not available in all studies. However, the ORIGIN study, in which repeat diet assessments at 2 years were conducted, showed similar results based on the first vs. second diet assessments. This indicates that misclassification of dietary intake during follow-up was not undermining the findings.

Seventh, one unique aspect of the study is the focus on only protective foods, i.e. a dietary pattern score that highlights what is missing from the food supply, especially in poorer world regions, but this does not negate the importance of limiting the consumption of harmful foods such as highly processed foods. While the PURE diet score had significantly stronger associations with events than other diet scores, the HRs were only slightly larger for PURE than for most other diet scores. However, the Planetary score was the least predictive of events. The analyses provide empirical evidence that all diet scores (other than the Planetary diet score) are of value to predicting death or CVD globally and in all regions of the world.

So, what should we, according to these findings, be looking for and how much of it should we consume? Here is the table that should answer these questions:

Fruits and vegetables 4 to 5 servings daily 1 medium apple, banana, pear; 1 cup leafy vegs; 1/2 cup other vegs
Legumes 3 to 4 servings weekly 1/2 cup beans or lentils
Nuts 7 servings weekly 1 oz., tree nuts or peanuts
Fish 2 to 3 servings weekly 3 oz. cooked (pack of cards size)
Dairy 14 servings weekly 1 cup milk or yogurt; 1 ½ oz cheese
Whole grainsc Moderate amounts (e.g. 1 serving daily) can be part of a healthy diet 1 slice (40 g) bread; ½ medium (40 g) flatbread; ½ cup (75–120 g) cooked rice, barley, buckwheat, semolina, polenta, bulgur, or quinoa
Unprocessed meatsc Moderate amounts (e.g. 1 serving daily) can be part of a healthy diet 3 oz. cooked red meat or poultry

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.

______________________________

A few short comments might be in order:

  1. Regulators have the duty to protect consumers from false health claims.
  2. 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.
  3. Such actions should, however, occur MUCH more often.
  4. They ought to happen also in countries other than the US.
  5. Similar actions should be initiated against ALL false claims made for healthcare products and services.
  6. 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.
  7. This would unquestionably amount to an enormously valuable service to public health.
  8. 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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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?

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.

In a video, Mr.Darkmoore speaks from a hospital bed and says the cause behind his visit to the emergency room stemmed from a chiropractor’s work on him. Three days ago, he had a ringing in his ear due to a long-term condition he knew as tinnitus. Thus, he decided to visit a chiropractor. “I figured $100 to a chiro, let them adjust a few things, if all else fails, I’ll go to a doctor,” explains Darkmoore.TikToker lands in hospital after going to chiropractor

This $100 visit led to several other complications and doctor’s bills worth thousands of dollars. The day after he was treated by the chiropractor, he experienced a headache that eventually led to dizzy spells. He decided to visit the emergency room where a CT scan was ordered which showed that the chiropractor had dissected an artery in his neck.

Next, Darkmoore was put on blood thinners to avoid blood clots that could result in a stroke or worse. Darkmoore explains that he will be on two blood thinners for the next three months to prevent clotting. If the dissection heals partially, he says he will need to take aspirin every day for the rest of his life. If it doesn’t heal, he claims that he will need surgery.

Many viewers of the video claimed they have had the same “chiropractor gone wrong” experience as Darkmoore.

  • “Wow. How scary. I had a similar thing happen to me. Extremely bad headache after going one time. Haven’t gone since,” one commenter wrote.
  • “I’m so sorry this happened to u,” another user echoed. “My chiropractor also caused an injury which required emergency surgery & I have permanent damage. I’m glad u survived.”

Darkmore captioned his last update video, “I appreciate the thoughts and prayers. Hopefully, I’ll be okay after 3 months of recovery.”

__________________

Let’s hope that he is correct and that he will make a speedy and full recovery.

Of course, chiros will queue up to stress that important details are missing in this case report. To them, I would merely say this:

THERE IS NO GOOD EVIDENCE THAT NECK MANIPULATIONS BRING ANY BENEFIT AND QUITE A BIT OF EVIDENCE THAT THEY CAN CAUSE SERIOUS HARM.

SO, WHY NOT JUST STOP OFFERING THE PROCEDURE?

We have discussed dental amalgam and its risks to human health before. Finally, there is new legislation in sight. The European Commission has revised the EU Mercury Regulation to protect EU citizens and the environment from toxic mercury. Among other things, this will completely ban the use of dental amalgam, for which 40 tons of mercury are currently consumed annually in the EU. The revised mercury ordinance provides for the following:
– No more use of dental amalgam from January 1, 2025; viable mercury-free alternatives are available.

– Ban on the manufacture and export of dental amalgam from the EU from January 1, 2025;

– Ban on the manufacture and export of six mercury-containing lamps from January 1, 2026 and January 1, 2028 (depending on lamp type).

The delegated act adopted under the Mercury Regulation transposes into EU law the decisions taken at the fourth Conference of the Parties (2022) to the Minamata Convention by introducing a ban on the production, import, and export of eight additional mercury-containing products, including mercury-containing lamps and non-electrical equipment.

The Minamata Convention is the main international legal framework for the protection of human health and the environment from anthropogenic emissions and releases of mercury to air, water, and soil. Like the Mercury Regulation, it addresses the entire life cycle of mercury, from primary mercury mining to mercury waste management.

The revised Mercury Regulation must now be approved by the European Parliament and the Council under the ordinary legislative procedure. The delegated act will be sent to the European Parliament and the Council for consideration.

Mercury is a highly toxic chemical that poses a threat to both human health and the environment. When released into the environment, it enters the food chain where it accumulates (mainly in fish). High mercury exposure can damage the brain, lungs, kidneys, and immune system.

Historically, mercury has been used in a wide range of applications, including gold mining, batteries, fluorescent tubes, thermometers, and barometers. Over the last twenty years, the EU has developed a comprehensive body of legislation, in particular the Mercury Regulation, which protects human health and the environment from anthropogenic emissions and releases of mercury, taking into account the entire life cycle of mercury from primary mercury mining to final disposal of mercury waste. It also includes measures on trade in mercury-containing products and mercury pollution.

The Minamata Convention entered into force on August 16, 2017, and has so far been ratified by the European Union and 143 countries, including all EU Member States. The fifth session of the Conference of the Parties to the Minamata Convention on Mercury (COP-5) will be held in Geneva, Switzerland, from October 30 to November 3, 2023.

_____________________________

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.

_________________________

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:

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.

Subscribe via email

Enter your email address to receive notifications of new blog posts by email.

Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories