Prevagen: Their False Advertising Stopped?

"Earlier this year, TINA.org received a complaint from a consumer regarding the continued deceptive marketing of Prevagen, the subject of a longstanding TINA.org investigation into unsupported claims that the brain supplement is 'clinically shown' to improve memory. It wasn’t the first time a consumer had expressed frustration about the supplement’s unsubstantiated health claims.

"Since filing a complaint with the FTC against the supplement’s maker, Quincy Bioscience, in 2015, TINA.org has regularly heard from consumers alarmed by the company’s deceptive claims that its jellyfish-based supplement improves memory and provides other cognitive benefits. One consumer who said she was a physician told us she was 'horrified' by the marketing, which targets millions of seniors worried about memory loss and cognitive impairment."

Click on the link below for more:

Prevagen Scrubs Memory-Improvement Claims Following Court Order

EFT: Just Another Pseudoscience Placebo

"The Emotional Freedom Technique (EFT), also referred to as tapping therapy or energy psychology, has been gaining popularity both as a self-help technique and psychological intervention. However, it remains firmly in the realm of pseudoscience and reveals significant weaknesses in the psychological research infrastructure.

"EFT is based explicitly on acupuncture/acupressure points, specific locations on so-called “meridians” in the body where 'energy' flows. Here is a typical definition:

• EFT works by tapping on acupressure meridians to release blockages. When these blockages are released, the problem feeling can be released and move through the body. The process starts with a beginning statement of what the problem feeling is and includes a complete acceptance and acknowledgment of the problem.

"This 'energy' allegedly ties negative emotions to an idea or thought, and proponents claim you can free yourself from those negative emotions by tapping energy points while repeating a reminder phrase. This, of course, is magical nonsense. Every component of this claim is not only prescientific superstition, they have been adequately shown to not be true."

Click on this link for more.

A History Of Medical Quackery

"Strange, weird or wonderful? You decide. The Vintage practices selling false hope. This practice preyed upon persons who suffered from diseases that may have had no complete medical cures. Unregulated once, this practice thrived with false or unproven claims of cures using strange ingredients or bizarre materials, often with dire consequences for the end user."

Click on this link for the details. It's a shame that, with today's knowledge, this sh!t still is a major problem. The cure? Universal education in critical/science-based thinking, beginning at an early age (to negate the religious indoctrination that most go through as children).

A Summary of Alternatives To Medicine

"Of the hundreds of different therapies that comprise SCAM, some (e.g., homeopathy, energy healing) are mere placebo treatments and thus unlikely to cause any direct harm (Ernst 2022). Others can cause adverse effects and complications that can be severe, sometimes even fatal. Examples of the latter category are:

• Chiropractic can cause death. My 2010 review summarized twenty-six fatalities after chiropractic spinal manipulations. The alleged pathology usually was a vascular accident involving the dissection of a vertebral artery (Ernst 2010).
• Acupuncture can cause injuries to thoracic and abdominal viscera, to the peripheral and central nervous systems, and to blood vessels. Deaths have also been recorded from pneumothorax and cardiac tamponade (Peuker et al. 1999).
• Herbal medicine can cause a wide range of adverse effects (Ernst 2004) and unwanted herb-drug interactions (Izzo and Ernst 2009).

"As no effective post-marketing surveillance exists in SCAM, the incidence of adverse events after SCAM use is essentially unknown."

Click on the link below for the entire article:

The Harm of So-Called Alternative Medicine

Consumer Health Digest #24-43 October 27, 2024

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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Misleading cancer books abound on Amazon

Researchers from the London School of Hygiene & Tropical Medicine, the University of Alberta’s Health Law Institute, and the University of Edinburgh’s Global Health Policy Unit searched for “cancer cure” on Amazon.com and reviewed the titles and descriptions of the top 1,000 English-language books from search results to determine whether the books provided cancer misinformation. Nearly half—494 books—were found to contain misleading cancer treatment or cure information. Of those:

• 97.3% of the misleading books were found to promote a treatment it claims can or has cured cancer
• 39.3% oversimplify cancer and cancer treatment
• 38.33% falsely justify ineffective treatments as science-based
• 34.2% attempt to discredit conventional cancer treatments
• 26.9% promote one treatment as curing all types of cancer and/or other diseases
• 26.7% present one treatment to cure all types of cancer
• 24.1% feature people with cancer, their families, or health practitioners finding new cancer cures and treatment options
• 16.6% claim cancer cures already exist but are hidden or banned because of financial interests from the pharmaceutical industry, legal battles with regulators or medical associations, and conspiracies to ruin reputations

The researchers concluded:

These results demonstrate that misleading cancer cure and treatment books are for sale, visible, and seemingly prevalent on Amazon.com. Nearly half of the “cancer cure” books for sale offered misleading and potentially harmful cancer treatment misinformation. Misleading books directly claimed to have efficacious cures for cancer, undermined scientifically supported treatments, misapplied scientific reasoning, oversimplified cancer and cancer treatments, and promoted conspiracy theories. Books offered information that may delay or encourage patients to opt out of best-standard treatments and create false hope.

Our study contributes to the increasing research documenting the presence, spread, and mechanisms of medical misinformation on Amazon. Notably, Amazon’s algorithm has been reported to amplify books with vaccine misinformation. In other cases, Amazon has been found to host products selling fake autism cures and promote COVID-19 misinformation. Amazon’s search results have been found to rank products with misinformation higher than sources debunking misinformation. Concerningly, misinformation in Amazon-hosted products may be amplified by fake product reviews, which are associated with a causal increase in product sales.

[Zenone M, and others. Selling misleading “cancer cure” books on Amazon: Systematic search on Amazon.com and thematic analysis. Journal of Medical Internet Research, e56354, 2024]

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FDA warns consumers not to use potentially contaminated homeopathic nasal spray

 The U.S. Food and Drug Administration (FDA) is warning consumers and health care professionals not to use SnoreStop Nasal Spray, distributed by Green Pharmaceuticals Inc. of Camarillo, California. The product may have microbial contamination that can potentially lead to infection, which can be life-threatening in certain patient populations such as immune-compromised individuals. SnoreStop Nasal Spray, an unapproved product, was previously sold on the company’s website and other sites and marketed for children beginning at age 5 and adults with unproven claims it opens air passages and relieves congestion.

FDA inspected the Green Pharmaceuticals facility in April 2024 and uncovered laboratory test results that reported significant microbial contamination in SnoreStop Nasal Spray lot number 2460. FDA investigators found evidence some products in this lot had been repackaged and distributed to customers for use as single units and in kits. On August 8, 2024, Green Pharmaceutical destroyed the remaining SnoreStop Nasal Spray from lot 2460 and other products the company had on-hand. FDA recommended Green Pharmaceuticals recall their SnoreStop Nasal Spray product on Aug. 13 and Sept. 12, 2024. The agency repeated its recall recommendation multiple times during this time, but as of September 18, the company did not recall the product from the market.

FDA issued a warning letter to Green Pharmaceuticals on December16, 2022, for distributing unapproved drugs and lacking quality controls over the products they sell. Additionally, the company voluntarily recalled one lot of SnoreStop NasoSpray on June 9, 2022, after FDA testing found the product contained microbial contamination identified as Providencia rettgeri. SnoreStop NasoSpray was renamed SnoreStop Nasal Spray following this recall. [FDA warns consumers not to use SnoreStop Nasal Spray by Green Pharmaceuticals due to potential contamination. FDA Drug Safety Communication, Sept 18, 2024]

According to the FDA’s announcement, the company subsequently stopped selling nasal spray products on its website. When the webpage to order the product was active, it indicated it was a homeopathic preparation with seven ingredients, five of which were diluted 6X or one part per million, one diluted 4X, and one diluted 12X. A blog post that remains on the SnoreStop website describes the nasal spray as “the best quality natural nasal spray to reduce snoring.” The website still has a page for ordering SnoreStop for Pets, described as a “homeopathic anti-snoring oral spray” and “the only natural anti-snoring solution for your pet’s snoring.” The FDA’s announcement said nothing about SnoreStop for Pets even though it has the same ingredient list as the potentially contaminated nasal spray.

###

Acupuncture paper in JAMA Internal Medicine denounced

 Steven Novella, M.D., an associate professor of neurology at Yale School of Medicine, has described the paper “Acupuncture vs, Sham Acupuncture for Chronic Sciatica from Herniated Disk: A Randomized Clinical Trial,” as “scientifically worthless.” The paper was published October 14, 2024, in JAMA Internal Medicine. He noted:

. . .the study was not double-blinded, the sham treatment used was inappropriate, the measured outcome was subjective, acupuncture is of implausible value, and the study came out of China where such studies have a near 100% bias toward positive results.

An Editor’s Note in JAMA Internal Medicine asserted the acupuncture study was “methodologically rigorous” and acupuncture is “an effective, evidence-based, non-pharmacological treatment” for chronic sciatica. In contrast, Dr. Novella concluded: “Doctors, other clinical professionals, and medical scientists need to maintain the highest levels of skepticism toward any claims or treatments in medicine. Otherwise, we will slide into pseudoscience. History is very clear on this fact.”

###

Circuit court backs FDA’s authority to regulate adipose cell therapy as a drug

The 9th Circuit Court of Appeals has ruled that stromal vascular fraction (SVF)—a mixture of stem cells, other cells, and cell debris spun down from patients’ own fat cells—is a drug that can be regulated by the U.S. Food and Drug Administration (FDA), and is not exempt under the FDA’s “same surgical procedure” exception. In 2018, FDA sued the California Stem Cell Treatment Center and the related Cell Surgical Network over its SVF treatments. In 2022, a federal judge in California sided with the center, ruling that those treatments weren’t subject to regulation. But the FDA appealed and won. In a similar lawsuit brought by the FDA against Florida-based U.S. Stem Cell Clinic over its SVF treatments, the clinic lost its case in 2019 and its appeal was subsequently denied. [Fiore K. Judge rules against stem cell clinic. MedPage Today, Oct 2, 2024]

==============

Stephen Barrett, M.D.

Consumer Advocate

7 Birchtree Circle

Chapel Hill, NC 27517

Telephone: (919) 533-6009 

http://www.quackwatch.org (health fraud and quackery)

http://www.acuwatch.org (skeptical guide to acupuncture history, theories, and practices)

http://www.allergywatch.org (guide to questionable theories and practices)

http://www.autism-watch.org (guide to autism)

http://www.cancertreatmentwatch.org (guide to intelligent treatment)

http://www.casewatch.net (legal archive)

http://www.chelationwatch.org (chelation therapy)

http://www.chirobase.org (skeptical guide to chiropractic history, theories, and practices)

http://www.credentialwatch.org (guide to health-related education and training)

http://www.dentalwatch.org (guide to dental care)

http://www.devicewatch.org (guide to questionable medical devices)

http://www.dietscam.org (guide to weight-control schemes and ripoffs)

http://www.fibrowatch.org (guide to the fibromyalgia marketplace)

http://www.homeowatch.org (guide to homeopathy)

http://www.ihealthpilot.org (guide to trustworthy health information)

http://www.infomercialwatch.org (guide to infomercials)

http://www.mentalhealthwatch.org (guide to the mental help marketplace)

http://www.mlmwatch.org (multi-level marketing)

http://www.naturowatch.org (skeptical guide to naturopathic history, theories, and practices)

http://www.nccamwatch.org (activities of the National Center for Complementary and Integrative Health)

http://www.ncahf.org (National Council Against Health Fraud archive

http://www.nutriwatch.org (nutrition facts and fallacies)

http://www.pharmwatch.org (guide to the drug marketplace and lower prices)

...

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RFKJr: Outside of Trump, The Most Dangerous Politician

"John Oliver discusses RFK Jr.’s potential to sway the presidential election, who his views are impacting on and off the campaign trail, and most importantly: what surprising little treat helps John get through the work week."

Click on this link for an expose of the many dangers of RFKJr. 

At Home Allergy Tests

"The at-home DIY health industry is booming. The global wellness product market was valued at $5.6 trillion in 2022 and is expected to grow to over $7 trillion by 2025. This includes dietary supplements, nutrition products, fitness equipment, health and wellness apps, and even unapproved consumer health tests.

"This market has exploded because of many factors, such as increased attention on overall health and well-being, lack of regulation on wellness products, aggressive marketing efforts by companies including paid promotion by celebrities and online influencers, and a coordinated effort to erode trust in evidence-based medicine.

"The immune system is a frequent target; everywhere you turn, there is a product advertising to “boost” your immune system, support immune health, diagnose foods you’re “sensitive” to, and more. Many legitimate scientific terms are co-opted by influencers in the wellness world to sell people on medical issues and products that are not based in reality, which only adds to the confusion among the public. Of course, the appeal is obvious: the immune system is the most complex organ system in the body and is involved in nearly every physiological process from infectious diseases, cancer, autoimmunity, allergies, and even things such as obesity and menstrual cycles. If you could control your immune system, you could truly hack your health.

"If only it were that simple. The reality is there is no evidence that these products are doing what they promise to do. Aside from the fact that these products are a waste of money, many can be seriously harmful. Supplements can be adulterated and contaminated, health tests can cause people to make serious changes to their lifestyle and habits, leading to malnutrition, disordered eating, and worse.

"There has also been an increased demand for at-home allergy testing. Before we get into it, I want to say unequivocally that at-home allergy tests should never be used for diagnosis. They are not FDA-approved or validated for use. Their methods and results are not accurate and trusting them can lead to harmful consequences."

Click on this link for more.

Bullibility And Wellness

"First off, you're asking what this word bullibility means. It is a portmanteau of two words, the first of which begins with bull and is often abbreviated BS, and gullibility. Coined by Petrocelli et. al. in a 2024 publication, bullibility refers to a person's predisposition to gullibly believe in any random BS that comes along. The TikTok generation, for example, has high bullibility. Today we're going to explore the role bullibility plays in converting so many people into members of what has become essentially a cult: wellness culture.

"The #1 absolutely critical thing to be clear about in this episode is the unambiguous distinction between healthcare and wellness. They are two unrelated industries, though both often borrow language from the other for marketing purposes — and it's important to be aware of that. Healthcare is the business of treating illness, but the wellness industry treats nothing. Its customers are already healthy — health being defined as the absence of disease — and instead it sells the promise of becoming healthier than healthy. There is always one more wellness fad you can buy into: the whole industry leverages the practices and precepts of New Age, eastern mysticism, and western esotericism to market and sell the commercial products of the organic food industry, alternative medicine, superfoods, and services like sound healing, yoga instruction, guided mindfulness, and countless others. It's so broad there is a product or service for anyone — a gateway to bring any new recruit into the cult. Whether you innocently buy a superfood fruit juice at the market or sign up for a Kambo workshop in Silicon Valley, congratulations, you've just taken your first step into the cult of wellness."

Click on the link below for more:

Bullibility and the Cult of Wellness

Prevagen: The Poster Child For Media Failure On Quackery

"New York Attorney General Letitia James today announced that a federal judge in Manhattan accepted a jury’s finding that Quincy Bioscience Holding Company, Inc., Quincy Bioscience, LLC, Prevagen, Inc., Quincy Bioscience Manufacturing, LLC (Quincy), and four corporate defendants made fraudulent and deceptive statements about the supplement Prevagen and are liable for violating New York’s consumer protection laws. Quincy advertised its supplement, Prevagen, in media markets across New York, including in Albany, Syracuse, New York City, and the Southern Tier, as a way to reduce memory problems, improve memory, and support cognitive health. After a two-week trial, the jury concluded that Quincy had not substantiated any of its claims about Prevagen with reliable scientific evidence." (link)

Why are supplements legally advertised? There must be more than the FDA's warning, you can hardly read it because it's so small.

Nootropics Supplements: Typical Quackery

"Chris Kresser is a licensed acupuncturist and self-identified proponent and practitioner of functional medicine and ancestral health. He has his own website with lots of health information, articles, and links to various businesses, many his own. It’s important to know that he doesn’t have any formal training in medicine or research.

"ACSH recently published an explainer piece on nootropics briefly touching on the idea that prominent wellness influencers often have their own lines of supplements that may include nootropics. Kresser is a prime example. In a 2024 article about nootropics on his website, Kresser discusses his favorite caffeine-free nootropics to help you “enhance your brainpower, sharpen your focus, and protect your cognitive health as you age.” They include citicoline, lion’s mane mushroom, phosphatidylserine, Bacopa monnieri, ginkgo biloba, uridine monophosphate, and alpinia galanga. Let’s go through these one by one."

Click here for the rest of the article.

Mental Health Quackery

"Dr. Stea is a clinical psychologist and an adjunct assistant professor at the University of Calgary. He’s also spent years fighting pseudoscience and mental health misinformation on social media. 

"In his book 'Mind the Science: Saving Your Mental Health from the Wellness Industry', Dr. Stea helps readers make better decisions about their mental health."

Click on the link below for a one-hour video delving into the shady goings-on within the "Wellness" industry:

A clinical psychologist takes on mental health pseudoscience

Bogus “Alternative Medicine” Diagnoses Described

"Professor Edzard Ernst, who was the world’s first department chairperson in complementary medicine, has posted on his blog a four-part series on the fake diagnoses of so-called alternative medicine.

Part 1 addresses adrenal fatigue, candidiasis hypersensitivity, and alleged chronic intoxications eliminated by so-called “detox” treatments.
Part 2 addresses chronic Lyme disease, electromagnetic hypersensitivity, and homosexuality.
Part 3 addresses leaky gut syndrome, multiple chemical sensitivity, and neurasthenia.
Part 4 covers vaccine overload, vertebral subluxation, and yin/yang imbalance."

(From the Consumer Health Digest #24-21. May 26, 2024)

- - - - - - - -

Dr. Ernst focuses on some of the more common bogus diagnoses of which we should be aware:

Be Careful What You Rub On Your Skin

"The U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency issued warning letters to six companies for marketing these products in violation of federal law."

Click on the link below for the details:

FDA Warns Consumers to Avoid Certain Topical Pain Relief Products

CBD: Question The Claims About It

Highlights

•Cannabidiol (CBD) products have varying amounts of CBD, from none to much more than advertised.
•CBD products may contain other chemicals than CBD, some of which may be harmful.
•Sixteen RCTs for pain used pharmaceutical CBD in oral, buccal/sublingual, and topical forms.
•Fifteen of the 16 RCTs were negative: no greater pain-relieving effect for CBD than for placebo.
•Meta-analyses link CBD to increased rates of serious adverse events and hepatotoxicity.

Click on the link below for the details:

Cannabidiol (CBD) Products for Pain: Ineffective, Expensive, and With Potential Harms

PTSD And Eye Movement Desensitization and Reprocessing (EMDR): Quackery

"Today we're going to unravel a specific type of psychotherapy, and it's one that presents the researcher with formidable walls to scale of both support and criticism. Some psychotherapists are firm believers; some are firm detractors. The therapy is called EMDR, Eye Movement Desensitization and Reprocessing. It is controversial as the day is long, and yet it enjoys broad recommendations in most of the world's major guidelines. It also has plenty of criticism of its effectiveness. And it has a wildly unscientific origin story, which never bodes well for any kind of treatment. So now let's dive in and find out if EMDR is for real or phony.

"EMDR is one of a number of treatments for Post-Traumatic Stress Disorder (PTSD), a potentially serious and debilitating condition in which certain traumatic memories can trigger anything from nightmares and anxiety to an uncontrollable emotional breakdown to a complete dissociative episode. The idea is to reduce the emotional distress associated with traumatic memories, and when used as an adjunct to other therapies, EMDR does this by attempting to get the brain to reprocess those memories via bilateral stimulation. Whether bilateral stimulation can actually do that is mainly where the controversy around EMDR lies. The stimulation is usually guided eye movements back and forth, but can also be tactile or auditory: tapping or holding a buzzer in each hand, or hearing tones played through headphones alternating between left and right. A typical EMDR session would include the patient recalling and talking about their traumatic memory while the therapist moves a pointer from side to side in front of them, for the patient to follow with their eyes. If you were uninitiated and saw this happening, you might well be inclined to wonder what kind of freaky woo you had just walked into."

Click on the link below for more:

EMDR: Looking Past the Pain