Consumer Health Digest, Issue #24-13

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📅 November 23, 2024 ✍️ By Dawn Lopez ⏱️ 42 Mins Read 🗂️ Blog 🕒 Last updated: November 23, 2024 📌 Tags:Consumer Health Digest

FDA warns about pain-relief products containing excessive drug doses.
Researchers raise doubts about CBD products promoted for pain relief.
FDA criticized for settling lawsuit by ivermectin-misinformation promoters.
Lawsuit alleges Women’s Cancer Fund is sham charity.

FDA warns about pain-relief products containing excessive drug doses. The U.S. Food and Drug Administration (FDA) is warning consumers not to use certain over-the-counter analgesic (pain relief) products marketed for use on the skin to relieve pain before, during, or after cosmetic procedures such as microdermabrasion, laser hair removal, tattooing and piercing. [FDA warns consumers to avoid certain topical pain relief products due to potential for dangerous health effects. FDA news release, March 26, 2024] Some of these products are labeled to contain ingredients such as lidocaine at concentrations higher than what is permitted for over-the-counter, topical pain-relief products. The FDA is aware of reports of adverse events related to these products. When these products are applied in ways that could lead to increased absorption through the skin, they can result in serious injury such as irregular heartbeat, seizures, and breathing difficulties. These products may also interact with medications or dietary supplements a consumer is taking. The FDA has issued warning letters for marketing these products in violation of federal law to six companies:

TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40%, and J-CAIN cream [LIDOCAINE] 29.9%
SeeNext Venture, Ltd.: NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), and NumbSkin 10.56% Lidocaine Numbing Cream
Tattoo Numbing Cream Co.: Signature Tattoo Numbing Cream and Miracle Numb Spray
Sky Bank Media, LLC, doing business as Painless Tattoo Co.: Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray
Dermal Source, Inc.: New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine, and Maximum Zone 1
Indelicare, doing business as INKEEZE: INKEEZE Original B Numb Numbing Gel, INKEEZE B Numb Numbing Spray Black Label, and INKEEZE B Numb Numbing Foam Soap

The FDA has warned consumers about similar products over the past decade. It recommends against:

using over-the-counter (OTC) pain-relief products with more than 4% lidocaine on the skin
applying OTC pain-relief products heavily over large areas of skin or to irritated or broken skin
wrapping skin treated with OTC pain-relief products with plastic wrap or other dressings, which can increase the chance of serious side effects

Researchers raise doubts about CBD products promoted for pain relief. Based on their literature review of cannabidiol (CBD) products’ purity, harmful effects, and effectiveness, researchers from the U.K. and the University of Alberta have concluded: “For people living with pain, the evidence for CBD or hemp extract shows it is expensive, does not work, and is possibly harmful.” [Moore A, and others. Cannabidiol (CBD) products for pain: Ineffective, expensive, and with potential harms. The Journal of Pain, 25(4):833-842, 2024] Their key findings were:

CBD products have varying amounts of CBD, from none to much more than advertised.
CBD products may contain other chemicals that may be harmful.
Out of 16 randomized clinical trials for pain using pharmaceutical CBD in oral, buccal/sublingual, and topical forms, 15 found no greater pain-relieving effect for CBD than for placebo.
Meta-analyses link CBD to increased rates of serious adverse events and liver toxicity.

FDA criticized for settling lawsuit by ivermectin-misinformation promoters. Business columnist Michael Hiltzik has criticized the FDA for settling a lawsuit brought by three physicians in 2022 claiming the FDA’s advisories improperly discouraged the use of the anti-parasite drug ivermectin for treating or preventing COVID-19. [Hiltzik M. FDA shoots itself in the foot by settling a groundless lawsuit over its ivermectin warnings. Los Angeles Times, March 26, 2024] The agency settled the case by agreeing to delete three social media posts and a consumer advisory titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” A federal judge in Texas had thrown out their case, but the 5th Circuit Court of Appeals reinstated it last year, returning it to the original judge for reconsideration. Hiltzik reported the FDA said it chose to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old. Hiltzik called the settlement a blunder, however, because:

“It leaves on the books the 5th Circuit’s adverse ruling, in which a panel of three judges found that the FDA’s advisory crossed the line from informing consumers, which they said is all right, to recommending that consumers take some action, which they said is not all right.”
The 5th Circuit’s ruling was a misinterpretation of the law, which might be used to litigate against the FDA for:
- current consumer advisories such as “Don’t believe the hype. . . Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So, beware of potentially dangerous procedures.”
- future advisories that discourage product misuse.
Unwary consumers may be misled by announcements from the plaintiffs’ camp, such as:
- “‘The FDA loses its war on ivermectin”
- the case was about “FDA overreach into the doctor–patient relationship.”
- a tweet posted by Bowden endorsed by Robert F. Kennedy, Jr., a leading source of healthcare disinformation.

Lawsuit alleges Women’s Cancer Fund is sham charity. The Federal Trade Commission and 10 states are suing Cancer Recovery Foundation International (also known as Women’s Cancer Fund) and its operator, Gregory B. Anderson, for deceiving donors. The 10 states are California, Florida, Maryland, Massachusetts, North Carolina, Oklahoma, Oregon, Texas, Virginia, and Wisconsin. [FTC, 10 states take action against operator of sham cancer charity for deceiving donors. FTC press release, March 11, 2024] The government’s complaint, filed in federal court, alleges:

Between 2017 and 2022, Women’s Cancer Fund collected more than $18.25 million from donors, promising donors their gift would go to directly help cancer patients and their families who were in need and assist them with basic living expenses such as rent, utilities, and food for their children. Instead, however, the overwhelming majority of the donations benefited Anderson and the for-profit fundraisers he hired.
Only $194,809—roughly 1%— was spent directly on helping women with cancer, while Anderson paid himself over $775,139 and paid the for-profit fundraisers he worked with over $15.55 million (85% of the total raised). The remaining amount went to paying for defendants’ overhead expenses.

Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H., with help from Stephen Barrett, M.D., It summarizes scientific reports; legislative developments; enforcement actions; other news items; Web site evaluations; recommended and nonrecommended books; research tips; and other information relevant to consumer protection and consumer decision-making. The Digest’s primary focus is on health, but occasionally it includes non-health scams and practical tips. Items posted to this archive may be updated when relevant information becomes available. To subscribe, click here.

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Complaint filed against physician promoting “holistic” cancer treatments.
Tainted red yeast rice supplements linked to serious complications.
Medical debt linked to worse population health in the U.S.
Food myths debunked.

Complaint filed against physician promoting “holistic” cancer treatments. On May 11, 2023, the Indiana Attorney General’s office submitted a complaint to the Indiana Medical Licensing Board accusing Clifford W. Fetters, M.D., of false and misleading advertising, failing to inform patients of side effects of tests and treatments, and not providing a patient with a truthful account of her condition. The state reportedly started receiving complaints from patients’ families starting in 2017. [Kenney K. “I’d like to see him lose his license”: Widowed man hopeful as state files complaint against Carmel doctor. WRTV Indianapolis, March 7, 2024] The complaint stated:

Fetters started Health and Wellness of Carmel (“H&W”) in 2006, owns it, and practices medicine there.
H&W provides holistic medical care for children and adults, offering “Alternative Cancer Treatments,” IV Nutritional Therapy, Integrative Medical Services, Health and Wellness Management, and Aesthetic Services.
“Alternative cancer treatments” at H&W include holistic cancer treatments, personalized cancer testing, tests for circulating tumor cells, RGCC cancer sensitivity tests, far infrared heat sauna, immune support therapy, supportive oligonucleotide technique (“SOT”), PrimeSPOT, sono- and photo-dynamic therapy, and Vaxo-Q-Re.
In May 2022, H&W began advertising:
- “through the use of holistic cancer treatment, [H&W] can effectively boost the immune system of [their] patients, as well as eliminate toxins in their body”
- several options for IV therapy for cancer treatment that include vitamin C, vitamin K3, IV ozone therapy, and hyperthermia
- ozone has “many therapeutic properties” and “[c]an be used as part of a therapeutic plan for almost every disease,” including cancer
- vitamin C “may work in killing cancer (chemotherapeutic action)” by “increased production of hydrogen peroxide production (prooxidant), anti-angiogenesis (stop the blood supply that feeds cancer), immune system support (interferon, interleukin, etc.), and anti-inflammatory.”
According to the Code of Federal Regulations, Title 21: (a) “Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy,” and (b) “A number of devices currently on the market generate ozone by design or as a byproduct. Since exposure to ozone above a certain concentration can be injurious to health, any such device will be considered adulterated and/or misbranded.”
Fetters authored a blog on the H&W website claiming IV therapy helps treat cancer.
Fetters engaged in misconduct in the treatment of four patients with a variety of treatments. Two of the patients died.
Fetters advertised tests and treatments not supported by current professional theory or practice and not indicated for specific patients.
Fetters failed to inform a patient of side effects of treatment offered.
Fetters failed to give a patient a truthful and candid account of her condition.
On July 23, 2021, the Indiana Medical Review Panel determined that the evidence supported the conclusion that Fetters failed to meet the applicable standard of care.

Tainted red yeast rice supplements linked to serious complications. Kobayashi Pharmaceutical’s beni kōji red yeast rice supplements have been linked to at least five deaths, 188 hospitalizations, and 1,058 doctor visits. The sicknesses have included kidney failure. Eleven people in Taiwan have reported feeling ill after consuming the supplements. The company has received around 40,000 inquiries from consumers. The cause of the illnesses has not been confirmed, but it is likely a potentially harmful substance derived from blue mold that entered the supplements during the manufacturing process in a batch of products made at the company’s Osaka factory. [Inoue Y. Kobayashi Pharma’s wide supply chain complicates search for tainted products. The Japan Times, April 4, 2024] The first report of illness linked to the supplement came in mid-January but the company didn’t issue a voluntary recall until March 22. [Kageyama Y. Japanese officials inspect 2 factories making health supplements linked to 5 deaths. Associated Press, March 30, 2024] The supplements were promoted for lowering blood cholesterol levels. According to the Mayo Clinic, while red yeast rice can lower cholesterol as statin drug products do, there’s less assurance regarding quality and how much active ingredient is actually in the product.

Medical debt linked to worse population health in the U.S. American Cancer Society researchers have found “consistent associations between medical debt and worse population health across multiple measures, including self-reported unhealthy days, years of life lost due to premature death, and. . . mortality rates.” Their analysis was based on nationwide medical-debt data for U.S. counties from the Urban Institute Debt in America project and health surveillance data from the County Health Rankings & Roadmaps compiled by the University of Wisconsin Population Health Institute. Data for a total of 2,943 counties—93% of all U.S. counties—were included in their analysis. The primary measure of medical debt for each county was the percentage of people with a credit bureau record who have any medical debt in collections. The secondary county measure was the median amount of medical debt among people with any medical debt in collections. [Han X, and others. Associations of medical debt with health status, premature death, and mortality in the US. JAMA Network Open 7(3):e2354766, March 4, 2024]

In a commentary about the study, physicians with the Fred Hutchinson Cancer Center and the University of Washington, Seattle, concluded:

Surely, everyone can agree that a consequence of accessing health care should not be worse health. For those who incur medical debt, this unfortunately appears to be their reality. The authors’ findings suggest that investing resources into debt prevention and mitigation may ultimately conserve downstream medical costs by improving population-level health. This is a key implication of the study. Our collective action today to address unsustainable debt may pay off substantial dividends in the future with dollars and lives saved. [Su CT, Ramsey SD. Medical debt—An iatrogenic epidemic with mortal consequences. JAMA Network Open 7(3):e2354707, March 4, 2024]

Another recent article describes the struggles of people in the southwestern Denver neighborhood of Westwood. This area has some of the highest levels of medical debt in Colorado where more than 20% of adults have historically had unpaid medical bills on their credit reports. [Bichell RE, Toomer L. Medical debt affects much of America, but Colorado immigrants are hit especially hard. KFF Health News, April 3, 2024]

Food myths debunked. In Does Coffee Cause Cancer? And 8 More Myths about the Food We Eat (ECW Press, 2023), Dr. Christopher Labos, a health columnist, podcaster, Montreal resident, and cardiologist with a master’s degree in epidemiology, discusses how sloppy science perpetuates popular misconceptions about food. In his book, the author discusses, among other things, whether vitamin C prevents the common cold, whether hot dogs are as bad as cigarettes, and whether red wine is good for your heart. A recording of Dr. Labos’s Skeptical Inquirer Presents talk on April 4, 2024 is also available.

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Lyme disease: Fact vs fiction.
NHS releases comprehensive review of gender identity care for youth.

Lyme disease: Fact vs fiction. Andrea Love, Ph.D. (immunology and biology), Executive Director of the American Lyme Disease Foundation, has launched an online “Inside Immunology” column at Skeptical Inquirer. Her first column, which provides an overview of Lyme disease issues for consumers, discusses:

the risk of infection with the bacteria that cause the disease
factors influencing whether a tick bite will lead to infection
symptoms of localized disease
the small risk of disease spreading beyond the skin
effective treatments
diagnostic issues
fraudulent tests and unproven, dangerous, and expensive long-term treatments ordered by self-proclaimed Lyme specialists including those who call themselves “Lyme literate”
overdiagnosis promoted by celebrities aligned with prominent activist organizations that purport to be patient advocates

She concludes:

Lyme pseudoscience causes immense harm to individuals who [undergo] harmful and unproven treatments based on false information. It also erodes public health and trust in science, and it can lead people to delay care for medical conditions that are falsely attributed to Lyme. We have a duty to combat this type of predatory pseudoscience, even if it has a loud voice.

[Love A. Why Is Lyme disease, an acute bacterial infection, plagued with misinformation? A convergence of misunderstanding, bad actors, media attention, and fear-based messaging. Skeptical Inquirer, April 11, 2024]

NHS releases comprehensive review of gender identity care for youth. England’s National Health Service (NHS) has released the final report of The Cass Review: Independent Review of Gender Identity Services for Children and Young People. The report’s purpose is to improve services for children and young people experiencing gender-identity-related distress. The report concludes:

There is no simple explanation for the increase in the numbers of predominantly young people and young adults who have a trans- or gender-diverse identity, but there is broad agreement it is a result of a complex interplay between biological, psychological, and social factors.
There are conflicting views about the clinical approach, with expectations of care at times being far from usual clinical practice.
While much research has been published in this field, systematic evidence reviews demonstrate the poor quality of the published studies, meaning there is not a reliable evidence base upon which to make clinical decisions, or for children and their families to make informed choices.
The strengths and weaknesses of the evidence base on the care of children and young people are often misrepresented and overstated, both in scientific publications and social debate.
The controversy surrounding the use of medical treatments has taken focus away from what the individualized care and treatment is intended to achieve for individuals seeking support from NHS gender services.
The rationale for early puberty suppression remains unclear, with weak evidence regarding the impact on gender dysphoria, mental, or psychosocial health. The effect on cognitive and psychosexual development remains unknown.
The use of masculinizing/feminizing hormones in those under the age of 18 also presents many unknowns, despite their longstanding use in the adult transgender population. The lack of long-term follow-up data on those commencing treatment at an earlier age means we have inadequate information about the range of outcomes for this group.
Clinicians are unable to determine with any certainty which children and young people will go on to have an enduring trans identity.
For most young people, a medical pathway will not be the best way to manage their gender-related distress. For those for whom a medical pathway is clinically indicated, it is not enough to provide this without also addressing wider mental health and/or psychosocially challenging problems.
Innovation is important if medicine is to move forward, but there must be a proportionate level of monitoring, oversight and regulation that does not stifle progress while preventing creep of unproven approaches into clinical practice. Innovation must draw from and contribute to the evidence base.

The report’s recommendations include:

Children/young people referred to NHS gender services must receive a holistic assessment of their needs to inform an individualized care plan. This should include screening for neurodevelopmental conditions, including autism spectrum disorder, and a mental health assessment.
Standard evidence-based psychological and psychopharmacological treatment approaches should be used to support the management of the associated distress from gender incongruence and co-occurring conditions, including support for parents/caregivers and siblings, as appropriate.
Services should establish a separate pathway for pre-pubertal children and their families, ensuring they are prioritized for early discussion about how parents can best support their child in a balanced and non-judgmental way. When decisions are made about social transition of pre-pubertal children, services should ensure they can be seen as early as possible by a clinical professional with relevant experience.
There needs to be provision for people who wish to stop or reverse their transition.
A full program of research should be established to look at the characteristics, interventions and outcomes of every young person presenting to the NHS gender services.
The option to provide masculinizing/feminizing hormones from age 16 is available, but the Review recommends extreme caution. There should be a clear clinical rationale for providing hormones at this stage rather than waiting until an individual reaches 18.
The puberty-blocker trial previously announced by NHS England should be part of a program of research that also evaluates outcomes of psychosocial interventions and masculinizing/feminizing hormones.

[The Cass Review. Independent review of gender identity services for children and young people: Final report, April 2024]

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Experts detail healthy eating patterns.
KFF spotlights shortage of primary-care doctors.
FDA warns ammonia inhalant marketer about drug violations.
Two-day MLM conference open for free registration.

Experts detail healthy eating patterns. Nutrition experts affiliated with the Pennington Biomedical Research Center in the Louisiana State University System, Rutgers University, and the Rutgers–Robert Wood Johnson School of Medicine have provided an overview of energy and macronutrients (proteins, fats, and carbohydrates) needed to minimize risks of chronic disease. They also suggest using an online calculator that outlines calorie needs based on a patient’s gender, age, weight, height, physical activity level, and pregnancy or lactation status. Modifications may be needed for patients with underlying health conditions. The calculator also gives intake recommendations for other macronutrients, total fiber, fatty acids, cholesterol, and water. The article gives this advice:

Healthy food intake patterns consistent with macronutrient Dietary Reference Intakes should be recommended for patients older than one year.
The core elements of healthy food patterns include vegetables of all types, fruits (especially whole fruits), grains (at least half of which are whole grains), dairy (e.g., fat-free or low-fat milk, yogurt, and cheese), protein foods (e.g., lean meats and eggs, seafood, beans, and nuts), and oils (e.g., plant and seafood oils). Healthy food intake patterns associated with relatively low all-cause mortality are also low in red and processed meat, high-fat dairy, and refined carbohydrates or sweets.
The Consumer Resources page connects to worksheets and other practical materials for healthful eating.
MyPlate, published by the USDA, presents a useful visualization that includes the five food groups (fruits, vegetables, grains, proteins, and dairy), along with healthy recipes and their energy and macronutrient content.
The Acceptable Macronutrient Distribution Ranges for adults are 10–35% for proteins, 20–35% for fats, and 45–65% for carbohydrates. Available evidence is limited or insufficient with regard to disease-prevention effects of dietary carbohydrate levels below the Acceptable Macronutrient Distribution Range.
The Dietary Guidelines for Americans, 2020–2025, addressed the question of alcoholic beverages as part of healthy food patterns. Alcoholic beverages can contribute to total daily calorie intake (ethanol is 7 kcal/g). The dietary guidelines state drinking less is better for health than drinking more. Adults of legal drinking age can choose to drink in moderation by limiting intake to two drinks or fewer in a day for men and one drink or fewer in a day for women. Some adults, including pregnant women, should not drink any alcohol.
Meet macronutrient needs with nutrient-dense foods and beverages that provide health-promoting components that have little or no added sugars or saturated fat.
Keep saturated fat intake at less than 10% of total calorie intake starting at two years of age.
Keep added sugar at less than 10% of total calorie intake starting at two years of age and avoid foods and beverages with added sugars for children who are under two years of age.
Maintain healthy fiber and water intakes as outlined in the Dietary Reference Intakes.
Use Nutrition Facts labels to monitor calorie and macronutrient contents of purchased foods

[Heymsfield SB, Shapses SA. Guidance on energy and macronutrients across the life span. The New England Journal of Medicine 390:1299-1310, 2024]

KFF spotlights shortage of primary-care doctors. A series of investigative reports by KFF Health News reveals how primary care in the U.S. has been disrupted and what this means for patients. In a video primer, “How Primary Care Is Being Disrupted,” senior correspondent Julie Appleby notes:

More than 100 million Americans lack regular access to primary care, a number that has nearly doubled since 2014. Yet demand for primary care is up, spurred partly by record enrollment in Affordable Care Act
The U.S. is investing in primary care far less than other high-income countries and has a smaller percentage of primary-care physicians than most of its European counterparts.
Only about one-third of physicians in the U.S. are primary-care doctors.
It’s often hard to find a doctor and make an appointment that is not weeks or even months away.
In 1980, 62% of doctor’s visits for adults 65 and older were for primary care and 38% were for specialists. By 2013, that ratio had exactly flipped.
Too few medical students are opting for primary care, in part because they are paid less than specialists.
Some doctors now in practice say they’re burned out.
Many doctors are retiring or selling their practices.
Hospitals, insurers, corporate giants such as Amazon, and private equity firms are on a buying spree, snapping up primary-care practices.
About 48% of primary-care physicians currently work in practices they do not own.
Some younger patients are ditching traditional primary care, opting instead for MinuteClinics or other quick and more convenient options such as telemedicine.
If patients aren’t seeing the same doctor on a regular basis, there’s a risk concerning health patterns may be overlooked.

FDA warns ammonia inhalant marketer about drug violations. After reviewing the social media accounts of Skull Smash LLC, the U.S. Food and Drug Administration (FDA) has warned the company its “Skull Smash® Ammonia Inhalants,” “Badass Bitch,” “Double Barrel Ammonia Inhalant,” and “Silver Bullet Ammonia Inhalants” are unapproved new drugs marketed in violation of the Federal Food Drug & Cosmetic Act. [Skull Smash. TruthInAdvertising.org Ad Alert, March 28, 2024] Questionable statements made on the Skull Smash website have included:

“Smelling salts are common in strength sports to help mentally stimulate and ‘psych up’ the lifter on competition day or in training to give them a boost on their competitive lifts. They are also popular in combat contact and team sports to increase alertness and focus.”
“Increased levels of alertness”
“Elevated levels of focus”
“Instantaneous boost of power and energy in competitive strength sports”

Two-day MLM conference open for free registration. The College of New Jersey School of Business is sponsoring its fourth annual conference on Multilevel Marketing: The Consumer Protection Challenge on Thursday, May 2 and Friday, May 3. This virtual conference brings together expertise from regulators, prosecutors former MLM distributors, social media consumer advocates, researchers, educators, and journalists to discuss ways to improve consumer protection and reduce consumer harm within the multilevel marketing (MLM) industry. Both sessions begin at 9:30 AM EDT. The conference is free, but registration is required. Videos of the previous three conferences are posted to the conference website.

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“Alternative” practitioner’s license temporarily suspended.
Royal College of Psychiatrists endorses Cass Report on pediatric gender-identity services.
Most nonmedical influencers’ sinusitis videos on TikTok deemed inaccurate.

“Alternative” practitioner’s license temporarily suspended. The Washington Medical Commission has temporarily suspended the license of Stephen L. Smith, M.D. His clinic, Northwest Integrative Medicine, is located in Kennewick, Washington. The action was taken after considering an Amended Statement of Charges that alleged Smith had provided substandard and poorly documented care to 38 patients and willfully misrepresented the facts regarding his care of three of them. The dubious treatments he allegedly provided to some patients included: (a) vitamin and ozone injections for back pain, (b) intravenous chelation, (c) high-dose ivermectin to a woman in her early thirties who did not have parasitic worms, and (d) intravenous infusions of vitamin C, glutathione, and exosomes based on non-evidence-based blood panels. Smith has had regulatory trouble in the past and has had restrictions placed on his practice for several years. [Barrett S. Stephen L. Smith, M.D., disciplined again for unprofessional practice. Quackwatch Dec 4, 2014]

Royal College of Psychiatrists endorses Cass Report on pediatric gender-identity services. The Royal College of Psychiatrists in the U.K. has provided a detailed response from its president, Dr. Lade Smith, CBE, to the final report of the independent review of gender-identity services for children and young people. The review was commissioned by NHS England and chaired by Dr. Hilary Cass, OBE. Key points in the response include:

“The report highlights concern around the evidence base for the interventions that have been used in providing gender-identity services in England. Children and young people in other spheres of healthcare routinely receive evidence-based treatment and rightly so. This should be the same for young people and children seeking support for their gender identity.”
“We strongly agree with the recommendations which seek to ensure there is proper evaluation of the risk and benefits of any intervention, and that transparent, high-quality data and research-led approaches are used.”
“It is also important to recognise trans members of the College and the wider trans community have raised concerns about the negative impact of the report. This includes how the review’s conclusions on the evidence base of different interventions and the need to wait for further research, in combination with the knowledge existing services are unable to meet demand, will leave gender-questioning children and young people feeling unsupported and unseen.”
“While the report presents challenges, it also offers a roadmap toward more effective, compassionate, and evidence-based care for transgender and gender-questioning children and young people. The Royal College of Psychiatrists will collaborate with stakeholders across the spectrum to implement these recommendations and improve outcomes for this underserved population.”

[Detailed response to The Cass Review’s Final Report. Royal College of Psychiatrists, Apr 22, 2024]

Several conclusions and recommendations from the Cass review’s final report were listed in the April 14th issue of Consumer Health Digest. The report raised concerns about the evidence for puberty-suppression treatments and the use of masculinizing/feminizing hormones in those under the age of 18. In contrast to the Cass review’s concerns, the Endocrine Society released a patient resource guide on “Transgender and Gender Diverse Children and Adolescents” on January 24, 2022, that: (a) suggested “puberty-blocking medications could be considered once an experienced clinician confirms the start of puberty” and (b) described the option of treating teens experiencing gender dysphoria with estrogen or testosterone hormones that affirm their gender identity.

Most nonmedical influencers’ sinusitis videos on TikTok deemed inaccurate. University of Chicago medicine and public health researchers identified 220 TikTok videos about sinusitis through a search during a 24-hour period in January 2023 using the hashtags “sinus,” “sinusitis,” and “sinus infection.” The videos were viewed a total of 330,771,103 times and shared 1,127,415 times. The researchers concluded:

48% of the videos were published by nonmedical influencers, or individuals with more than 10,000 followers on TikTok; 52% of those videos offered medical advice
lay individuals published 31% of videos—they mostly deal with lifestyle issues
20% of the videos were from medical professionals; 84% of these videos offered medical advice
information-accuracy ratings of “non-factual” were given to 45% of the videos
“non-factual” ratings were given to 55% of the nonmedical influencers’ videos, 16% of the medical professionals’ videos, and 46% of lay individuals’ videos
in comparison to videos by medical professionals, videos of nonmedical influencers and lay uploaders tended to have more harmful harm/benefit scores, fewer understandable videos, and lower overall quality scores

[Dimitroyannis R. and others. A social media quality review of popular sinusitis videos on TikTok. Otolaryngology—Head and Neck Surgery, March 3, 2024]

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Doctor who claimed vaccines magnetize people has her medical license reinstated.
Review supports hormone therapy for menopausal symptoms, not for disease prevention.
Center for Inquiry scrutinizes unproven menstrual-pain treatments
NY Times spotlights meat-only-diet promoters.

Doctor who claimed vaccines magnetize people has her medical license reinstated. On April 10, 2024, the Medical Board of Ohio reinstated the license of Sherri Jane Tenpenny, D.O. Tenpenny operates a “health restoration center” in Cleveland where her offerings include external counter pulsation. This a treatment for chest pain that she also claims can treat erectile dysfunction, kidney failure, high blood pressure, and Alzheimer’s disease. She also runs a multidisciplinary health center in Middleburg Heights that advertises itself as “known for getting people well and symptom-free without pharmaceutical drugs.” [Szilagy S. Medical license reinstated for doctor who made false claims against COVID-19 vaccines. NBC4 WCMH-TV, Columbus, OH, May 3, 2024]

Last August, the Board suspended Tenpenny’s license for an indefinite period of time and fined her $3,000 due to failure to:

cooperate in an investigation conducted by the board triggered by approximately 350 complaints it received following her bizarre testimony to the Ohio House Health Committee in 2021 about COVID-19 vaccines
comply with a subpoena or order issued by the board
truthfully answer a question presented by the board

According to the board hearing examiner’s Report and Recommendation accompanying its Entry of Order dated July 14, 2023, Tenpenny failed to respond to interrogatories about:

her practice, in general
her practice regarding recommendations about and the administration of vaccines and whether any of her patients subsequently contracted certain illnesses
the number of doses of COVID-19 vaccines she had provided
whether she had personally received a COVID-19 vaccine
her sources of evidence regarding her claims that: (a) COVID-19 vaccines cause people to become magnetized or create an interface with 5G towers; (b) vaccinated patients suffer complications such as abnormal bleedings, myocarditis, strokes, and neurological complications; and (c) some major metropolitan areas liquify dead bodies and pour them into the water supply

Tenpenny was listed fourth in the Center for Countering Digital Hate’s “Disinformation Dozen” report published in 2021 about the 12 anti-vaxxers responsible for almost two-thirds of the anti-vaccine content circulating on social media platforms. Press reports indicate thet her license was restored because she agreed to cooperate with the medical board in the future.

Review supports hormone therapy for menopausal symptoms, not for disease prevention. A review of four Women’s Health Initiative (WHI) randomized clinical trials that enrolled 68,132 postmenopausal U.S. women aged 50 to 79 years, and followed them for up to 20 years has found:

The WHI clinical trial results do not support hormone therapy with oral conjugated equine estrogens plus medroxyprogesterone acetate for postmenopausal women
the WHI clinical trial results do not support using conjugated equine estrogens alone for those with prior hysterectomy to prevent cardiovascular disease, dementia, or other chronic diseases
hormone therapy is effective for treating moderate to severe menopausal symptoms
the benefits of hormone therapy in early menopause, combined with lower rates of adverse effects, support initiation of hormone therapy before age 60 years for women without contraindications who have bothersome menopausal symptoms
there is no support for routinely recommending calcium plus vitamin D supplementation for fracture prevention in all postmenopausal women, except for those who do not meet national guidelines for recommended intakes of these nutrients through diet
evidence does not support using a low-fat dietary pattern with increased fruit, vegetable, and grain consumption for preventing breast or colorectal cancer
a potential role of a low-fat dietary pattern in reducing breast cancer mortality warrants further study

[Manson JE, and others. The Women’s Health Initiative randomized trials and clinical practice: A review. JAMA, May 1, 2024] The lead author of the review was interviewed on the “All Things Considered” radio program. [Aubrey A. Hormones for menopause are safe, study finds. Here’s what’s changed. NPR, May 1, 2024]

Unproven menstrual-pain treatments scrutinized. Skeptical Inquirer has published an insightful overview of diet, exercise, and supplements for menstrual pain. The article was excerpted from Blood: The Science, Medicine, and Mythology of Menstruation, the new book by obstetrician and gynecologist Jen Gunter, M.D. [Gunter J. Alternative therapies for menstrual pain. Skeptical Inquirer, 48(3), 2024] Her key points about alternative therapies for menstrual pain include:

“If the data were good, these therapies would be standard of care.”
“It’s not wrong to try an alternative therapy. It’s your body and your decision. What is wrong is for a medical provider to misrepresent the therapies. You can make an informed choice only if given accurate information.”
“Pain is an individual experience, and for some people who want to avoid pharmaceuticals, trying less-studied interventions, such as supplements, may be appealing.”
“Dietary changes, such as adding more fiber, fish, and plant-based protein and meeting the health guidelines of exercise, may or may not directly help with pain, but they will help overall health and should always be encouraged.”

NY Times spotlights meat-only-diet promoters. A New York Times style piece features the names of the most prominent promoters of eating only meat, seafood, and eggs with or without dairy and a little fruit added. [Kurutz S. Meet the men who eat meat (and only meat). The New York Times, April 30, 2024] These advocates include:

podcasters Joe Rogan, Lex Fridman, and Jordan Peterson
orthopedic surgeon Shawn Baker, author of the 2018 book The Carnivore Diet
fitness influencer Brian Johnson, who is known as the Liver King
medical doctor Paul Saladino, author of The Carnivore Code

The article notes their dietary recommendations are not supported by nutrition science.

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Nurse practitioner fined for falsifying children’s vaccination records.
Stem-cell biologists criticize Utah law promoting unproven “stem cell” products.
Psychologist weighs in on consumer mental health self-diagnosis.

Nurse practitioner fined for falsifying children’s vaccination records. The New York State Department of Health (DOH) has issued a $55,000 penalty as part of a Stipulation and Order signed by licensed nurse practitioner Sandra Miceli, who created 546 false immunization records for 116 school-aged or younger children from throughout the state. [State health department issues penalty to Rochester-area nurse for falsifying pediatric vaccine records. New York State Department of Health press release, May 7, 2024] The DOH has deleted the false immunization information and is informing the parents and guardians of affected children that their children’s vaccinations records no longer satisfy New York’s requirements for school enrollment and attendance. They must ensure their children receive all age-appropriate vaccinations before returning to school. In collaboration with the New York State Education Department (NYSED), DOH is also identifying and contacting all affected schools to inform them of this matter and their obligation to exclude unvaccinated and under-vaccinated students, and execute the required next steps.

Miceli has paid $30,000 of the $55,000 monetary penalty with the remainder suspended as long as she fully complies with the Public Health Law and all terms of the Stipulation and Order, that include:

permanent exclusion from the New York State Immunization Information System (NYSIIS), both directly or through anyone acting on her behalf
permanent prohibition from administering any immunization that must be reported to NYSIIS
prohibition from participating in any scheme or attempt to misrepresent any individual as having received immunization the individual, in fact, has not received

Miceli, who operated Surviving Naturally, a so-called “natural wellness center” in the Rochester suburb of Webster, New York, was also found to have repeatedly violated the Immunization Registry Law. DOH also determined Miceli has a long history of promoting misinformation about vaccines and vocally opposing immunization requirements. Miceli spread dangerous public-health falsehoods on social media and sowed fear about vaccines at the same time she claimed, as a licensed nurse practitioner, to be protecting public health by administering immunizations required for enrollment in schools and daycares. Her scheme began less than one month after New York State stopped permitting the use of non-medical vaccine exemptions. It affected children throughout the state. The majority live and attend school in Monroe County and elsewhere in Western New York, but a few were from as far away as New York City. The affected immunizations were for diphtheria, tetanus, pertussis (DTaP or Tdap), hepatitis B, measles, mumps, rubella, varicella (chickenpox), polio, meningococcus, Haemophilus influenzae type b (Hib), and rotavirus vaccine.

The NYSED, which licenses nurses, is assisting DOH in mitigating the public-health concerns caused by the scheme. It can pursue charges of professional misconduct against Miceli but has not yet indicated whether it will do so.

Stem cell biologists criticize Utah law promoting unproven “stem cell” products. Sean J. Morrison, Ph.D., Public Policy Committee Chair and former President of the International Society for Stem Cell Research, and Gerald J. Spangrude, Ph.D., Adjunct Professor at the Institute For Stem Cell Biology and Regenerative Medicine at Stanford University, have criticized Utah’s law SB 199, Placental Tissue Amendments, which took effect May 1st. [Morrison SJ, Spangrude GJ. Opinion: As stem cell biologists, we’re concerned a Utah law will lead to a boom in snake oil sales. The Salt Lake Tribune, May 1, 2024] The law makes it legal for companies to sell unproven, potentially harmful placental stem-cell products in Utah. It also undermines federal regulation by explicitly stating “A health care provider . . . may perform a stem-cell therapy that is not approved by the United States Food and Drug Administration.” The biologists concluded:

Individual patients and physicians rarely have the time, expertise or data access needed to evaluate the safety and effectiveness of experimental medical products. While SB 199 requires that providers disclose that products are not FDA-approved, this is already done by many companies that sell unproven therapies. This does not dissuade consumers from buying such therapies when the disclosure is coupled with misleading claims about effectiveness. “Buyer beware” is not an effective strategy when it comes to experimental medical products. The people of Utah are at risk of being harmed by a law that undermines federal regulation and promotes the sale of unproven therapies.

Psychologist weighs in on consumer mental health self-diagnosis. In his latest Behavior & Belief online column, psychologist Stuart Vyse, Ph.D., examined the trend of mental health self-diagnosis influenced by prescription drug advertising, advertising by hospitals and clinics, online videos, and smartphone apps. He also looked at barriers to getting a formal diagnosis. [Vyse S. Skip the doctor, just diagnose yourself. Skeptical Inquirer, May 6, 2024]

Potential benefits of self-diagnosis include: (a) labeling one’s condition can lead to seeking help, and (b) it can be appealing to find oneself part of a neurodivergent community. Potential harms include: (a) misdiagnosis causing “incorrect perceptions of one’s mental health and, as a result, can cause unnecessary stress and anxiety,” and (b) delays in starting appropriate treatments, in part, because of embracing a neurodivergent identity. Vyse concludes:

Sadly, in the United States, some people still cannot afford mental-health treatment, and there are, undoubtedly, other barriers to getting a formal diagnosis. But self-diagnosis is not the answer. There is no reasonable justification for rejecting the expertise of trained mental-health professionals, and self-diagnosis is inherently prone to biases that make the outcome suspect. In my view, it is always best to get a more objective opinion—or two—rather than do it yourself.

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FDA fails to protect consumers from scientifically unsupported dental device.
Drug-resistant infections attributed to stem cell treatments in Mexico.
Commentator lambastes Republican efforts opposing vaccine mandates.

FDA fails to protect consumers from scientifically unsupported dental device. KFF Health News and CBS News have published an update to their March 2023 joint investigation of the Anterior Growth Guidance Appliance (AGGA). The report notes the device was sold to at least 10,000 patients for about $7,000 each to treat jaw problems and obstructive sleep apnea, even though its use is not supported by peer-reviewed scientific research. [Kelman B. Werner A. FDA said it never inspected dental lab that made controversial AGGA device. KFF Health News, May 13, 2024] A patent application indicates the device resembles a retainer and uses springs to apply pressure to the front teeth and upper palate. More than 20 patients have alleged in lawsuits that the AGGA, typically worn for several months, resulted in flared teeth, damaged gums, exposed roots, erosion of the bone that holds teeth in place, and/or lost teeth. Documents obtained through the Freedom of Information Act indicate:

The U.S. Food and Drug Administration (FDA) “became aware” of the AGGA as a result of the March 2023 joint investigation.
Months later, the FDA inspected for the first time Indiana-based Johns Dental Laboratories, the exclusive manufacturer of the AGGA for over a decade.
That inspection found Johns: (a) didn’t require all customer complaints to be investigated, (b) did not investigate some complaints about people being hurt by products, including the AGGA, and (c) “never” forwarded the complaints to the FDA despite the requirement for device companies to do so.

The updated report also notes:

When asked to explain why it hadn’t previously inspected Johns Dental, the FDA said, based on what it knew at the time, it was not required to do so until 2018 when the company registered as a “contract manufacturer” of other medical devices.
Before 2018, the FDA was aware of the company operating only as a “dental laboratory;” the FDA doesn’t regularly inspect dental laboratories.
Dental laboratories don’t normally manufacture their own products; they only modify devices made by other companies to fit dentists’ specifications.
Without admitting liability and while denying wrongdoing, Johns Dental and device developer Tennessee dentist Steve Galella have settled lawsuits from 20 patients.
At least 13 more AGGA patients have filed similar lawsuits since the March 2023 joint investigation.
According to the newly released FDA documents, since the joint investigation, Johns Dental abruptly stopped making the AGGA.
The FDA inspected Johns Dental in July 2023 and issued seven citations on July 14th.
The Department of Justice has opened a criminal investigation into the AGGA that was ongoing as of December, according to court filings. Charges have not been filed.
“The entire concept of this device, of this treatment, makes zero sense,” said Kasey Li, a maxillofacial surgeon who coauthored a paper about patients treated with the AGGA or similar devices seeking second opinions. [Li K, Guilleminault C. Surgical and non-surgical maxillary expansion: expansion patterns; complications; and failures. L’Orthodnitie Française 93(1), December 2022]

Drug-resistant infections attributed to stem cell treatments in Mexico. Three U.S. patients who received donor embryonic stem cell injections not approved by the U.S. Food and Drug Administration at three different clinics in Mexico during 2022 have Mycobacterium abscessus infections. [Nguyen MH and others. Notes from the field: Potential outbreak of extrapulmonary Mycobacterium abscessus subspecies massiliense infections from stem cell treatment clinics in Mexico—Arizona and Colorado, 2022. Morbidity and Mortality Weekly Report 73:420-422, 2024] The patients, who were diagnosed and treated at two Colorado hospitals, included:

a Colorado woman in her thirties who received stem cell injections to treat her multiple sclerosis and developed meningitis
an Arizona man in his sixties who received stem cell injections for psoriatic arthritis and developed a right-elbow infection
a Colorado man in his sixties who received stem cell injections for osteoarthritis and developed infections in both knees

Mycobacterium abscessus infections are intrinsically drug-resistant. The Centers for Disease Control and Prevention advises that medical tourism can be risky. Infectious diseases and antimicrobial resistance are among the complications.

Commentator lambastes Republican efforts opposing vaccine mandates. Political commentator Charles Sykes has sounded the alarm about Republicans’ efforts that would undermine protections of students from infectious diseases. The efforts have included:

campaign speeches in which former President Donald Trump said he would not give one penny to any school that has a vaccine mandate
Trump increasing his anti-vaccine rhetoric on his Truth Social platform, where he even denounced presidential candidate and notorious vaccine alarmist Robert F. Kennedy, Jr. as not sufficiently hostile to vaccines
legislation proposed in state legislatures across the country that could limit the use of vaccines for measles, polio, and meningitis, often in the name of parental or religious rights
a bill passed by the Republican Legislature in West Virginia, but vetoed by GOP Gov. Jim Justice, that would have exempted students attending private, parochial, and virtual schools from vaccine mandates
a Wisconsin bill vetoed by Democratic Gov. Tony Evers that would have required public colleges and universities to provide exemptions “for reasons of health, religion, or personal conviction”

[Sykes C. Trump’s frightening 2025 pledge puts our children at risk. MSNBC, May 15, 2024]

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