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Consumer Health Digest #24-02
January 14, 2024

Restrictions placed on medical license of egregious promoter of COVID-19 disinformation

Following a five-day hearing regarding allegations that board certified pathologist Dr. Ryan N. Cole engaged in unprofessional conduct, the Washington Medical Commission restricted his license to practice as a physician and surgeon and placed it on oversight. [Pfannenstiel K. Washington regulators restrict medical license of Idaho doctor who spread COVID-19 disinformation
https://idahocapitalsun.com/2024/01/10/washington-regulators-restrict-medical-license-of-idaho-doctor-who-spread-covid-19-disinformation/
. Idaho Capital Sun, Jan 10, 2024]
According to the Commission’s Findings of Fact, Conclusions of Law, and Final Order
https://cdn.centerforinquiry.org/wp-content/uploads/sites/33/2024/01/15175332/order_2024.pdf
:

Cole is restricted from practicing primary-care medicine and from prescribing medications for patients in Washington.
His practice is restricted to the practice of pathology.
He must complete continuing medical education on COVID-19, pulmonary and respiratory diseases, medical record-keeping, and telehealth.
He must complete a specified program offered by the Center for Personalized Education for Physicians.
He must submit a paper to the Commission of a minimum of 1,000 words addressing professionalism, truthfulness, honesty in medicine, and how he intends to apply what he learned in his practice.
He must pay a $5,000 fine and assume all costs of complying with the order.
He must make periodic personal appearances in front of the Commission.
He may not seek modification of the Order for five years.
The Commission identified these and other demonstrably false and/or misleading statements Cole made in frequent presentations in public and private forums, on news shows, and on podcasts:

“Children survive [COVID-19] at a hundred percent.”
Asymptomatic spread of COVID-19 is “infinitesimally small.”
Ivermectin is “a known antiviral medication.”
Ivermectin decreases the COVID-19 death rate by 68–90% and acquisition by 86–88%.
The COVID-19 vaccination is “an experimental biological gene therapy, immune-modulatory injection” and “a fake vaccine…the clot shot, needle rape.”
The COVID-19 vaccination has caused more deaths than COVID-19 and has killed children.
The spike protein found in the COVID-19 vaccinations is a toxin that crosses the blood–brain barrier.
COVID-19 vaccination can lead to cancer and infertility.
“Normal [vitamin] D levels decrease [individuals’] COVID symptom severity and risk for hospitalization by 90%.”
“Aspirin decreases [COVID-19] hospitalization by 44%.”
The Commission also found he engaged in direct care of patients via telemedicine using the website MyFreeDoctor.com. It described the improper care he provided to four telemedicine patients for whom he prescribed ivermectin
https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19
. It also noted Cole followed the I-MASS protocol created by Dr. Pierre Kory. Kory testified that Dr. Cole met the standard of care, but the Commission concluded that Kory’s protocol “did not adhere to evidence-based standards.”

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Researchers warn of hazards of inadequately regulated dietary supplements

After a review of several databases, researchers with Touro College of Pharmacy and Nova Southeastern University’s College of Pharmacy have identified a total of 79,071 reported adverse events related to the use of dietary supplements. The events were reported to U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) between 2004 and 2021. Their searches for adverse-event reports included the use of vitamin E (vitamin derivative), beta-sitosterol (plant sterol) yohimbine, kava kava, kratom, garcinia cambogia, herbal products, and OxyElite Pro
https://www.ncbi.nlm.nih.gov/books/NBK548935/
 (marketed for weight loss).
[li W, Wertheimer A. Narrative review: The FDA’s perfunctory approach of dietary supplement regulations giving rise to copious reports of adverse events
https://pubs.lib.umn.edu/index.php/innovations/article/view/4989
. Innovations in Pharmacy, 14(1), 2023]

Key points made in their paper include:

Vitamin E supplementation has documented interaction with several routine medications.
Over a thousand adverse events regarding the use of a prostate support supplement called Super Beta Prostate containing beta-sitosterol were reported to CFSAN in the past two decades. Most of the reports involved finding blood in the urine.
Poison centers have received hundreds of reports of adverse events, some leading to hospitalizations linked to yohimbine use.
Kava kava has been linked to various symptoms and liver damage, in some cases leading to fatalities.
Kratom side effects include weight loss, dry mouth, liver damage, chills, change in urine, constipation, nausea, and vomiting. Poison control centers in the U.S. have received reports of spontaneous seizures, spikes in high blood pressure, and death among kratom users.
More than a thousand garcinia cambogia-related adverse events were documented from 2004 to 2021, with symptoms ranging from headache, nausea, and vomiting to liver injury or failure, and kidney disorders.
The researchers concluded:

Having only touched the surface of regulation, the FDA is in dire need of reform to control dietary supplements and prevent adverse effects through advancements in studies of efficacy and safety in addition to labeling updates emphasizing the potential harm stemming from use of these products. It is, therefore, highly recommended that this public health gap be closed by the FDA requiring safety and efficacy proof prior to marketing for supplements, as is done with most other health-related products. By implementing the same rigorous procedure of prescription medication review prior to marketing including preclinical research followed by clinical research and thorough FDA examination preceding approval and post-marketing monitoring, the significance in adverse events can be vastly reduced.

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FDA warns about complications of unapproved fat-dissolving injections.

The U.S. Food and Drug Administration (FDA) has received reports of adverse reactions to fat-dissolving injections that are not FDA-approved. The reactions have included permanent scars, serious infections, skin deformities, cysts, and deep, painful muscle knots. In addition, improper or unsafe injection practices by unlicensed personnel can increase the risk of scarring and skin infections. The safe and effective uses of these products depend on the correct number and location of injections, proper needle placement, and proper administration technique. Some consumers received the injections at clinics or medical spas by personnel who might not have been properly licensed to give the injections. Some consumers who reported complications purchased the drugs online and injected it themselves. Consumers should not purchase ingredients for unapproved fat-dissolving injections or inject the drugs themselves.

Unapproved fat-dissolving injections are being marketed online under brand names such as Aqualyx, Lipodissolve, Lipo Lab, Kabelline, and others. The FDA has not evaluated their safety or effectiveness. Sellers have claimed their products reduce fat deposits in areas of the body such as the chin, back, thighs, upper arms, and stomach. Common ingredients in these injections include phosphatidylcholine (PPC) and sodium deoxycholate (DC). These ingredients have been used alone or together, sometimes referred to as “PCDC injections.”

A prescription drug called Kybella, the brand name for deoxycholic acid, is the only fat-dissolving injectable drug that is FDA-approved. Its only approved use is to reduce the amount of fat under the chin (“double chin”) in adults. The approved label for Kybella notes injections should be administered by a health-care professional only.
[Using fat-dissolving injections that are not FDA-approved can be harmful
https://www.fda.gov/drugs/buying-using-medicine-safely/using-fat-dissolving-injections-are-not-fda-approved-can-be-harmful
. FDA, Dec 20, 2023]

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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)
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