Profits not People

Anker PowerCore Model Number A1263 (only 19 reports of fires and explosions!) RECALL

/ SupremeCmdr / 4 Comments

Note: Do not throw this recalled lithium-ion battery or device in the trash, in the general recycling stream (e.g., street-level or curbside recycling bins), or in used battery recycling boxes found at various retail and home improvement stores. Recalled lithium-ion batteries must be disposed of differently than other batteries, because they present a greater risk of fire. Your municipal household hazardous waste (HHW) collection center may accept this recalled lithium-ion battery or device for disposal. Before taking your battery or device to a HHW collection center, contact it ahead of time and ask whether it accepts recalled lithium-ion batteries. If it does not, contact your municipality for further guidance. More than One Million Anker Power Banks Recalled Due to Fire and Burn Hazards; Manufactured by Anker Innovations – https://www.cpsc.gov/Recalls/2025/More-than-One-Million-Anker-Power-Banks-Recalled-Due-to-Fire-and-Burn-Hazards-Manufactured-by-Anker-Innovations

Yikes. I was actually thinking of buying a power bank when I heard about this recall.

Obesity is Not a Disease

/ SupremeCmdr / Leave a comment

David L. Katz, MD, MPH, FACPM, FACP, FACLM is a specialist in Internal Medicine, Preventive Medicine/Public Health, and Lifestyle Medicine – globally recognized for expertise in chronic disease prevention, health promotion, and nutrition. The founding director of Yale University’s Prevention Research Center, and past president of the American College of Lifestyle Medicine, Katz is the founder of the non-profit True Health Initiative, founder of Diet ID, and Chief Medical Officer for leading food-as-medicine company, Tangelo. He is a senior science advisor to Blue Zones. He holds multiple US patents, including for advances in dietary assessment. He has roughly 250 peer-reviewed publications, has authored 19 books- including multiple editions of a leading textbooks in nutrition and preventive medicine, and has earned numerous awards for his contributions to public health, including three honorary doctoral degrees.

https://www.vumedi.com/video/obesity-is-not-a-disease-so-what-is-it

Diet until proven otherwise.

Glenmark Pharmaceuticals Recall (check your prescription bottles)

/ SupremeCmdr / Leave a comment

In February, the FDA found problems with cleaning and testing at the plant in Madhya Pradesh, India, which was the subject of a ProPublica investigation last year. The current recalls, listed in an FDA enforcement report last week, cover a wide range of commonly prescribed medicines, including ones that treat epilepsy, diabetes, multiple sclerosis, heart disease and high blood pressure, among other ailments. ​​A full list of the recalled medications is available here. An Indian Drugmaker, Investigated by ProPublica Last Year, Has Recalled Two Dozen Medications Sold to U.S. Patients https://www.propublica.org/article/glenmark-recalls-two-dozen-drugs

Time to bring the pharma supply chain back onshore.

Controlled Substance Prescribing Patterns – Pennsylvania

/ SupremeCmdr / Leave a comment

Rates of psychostimulant (stimulant)-related overdose deaths in the United States have increased substantially since 2010; in 2022, 32% of all overdose deaths involved stimulants. Citation: Hayden S, Murzynski SM, Bolton A, Goetz CT. Controlled Substance Prescribing Patterns Among Fatal Overdose Decedents with an Opioid, Stimulant, or Both Contributing to Death — Pennsylvania, 2017–2022. MMWR Morb Mortal Wkly Rep 2025;74:205–209. DOI: http://dx.doi.org/10.15585/mmwr.mm7412a2

Prescribed stimulants. Read more here – https://www.dea.gov/factsheets/stimulants

Happy Friday!

Compounding Compounds the Problem

/ SupremeCmdr / Leave a comment

Compound pharmacies that bulk produce weight-loss drugs without FDA approval are doing so without that oversight.  And because compounding pharmacies aren’t required to report instances of patient harm involving their medications, problems may go undetected.“It’s kind of like ‘Whack-A-Mole,’” said Al Carter, a pharmacist and executive director at the National Association of Boards of Pharmacy. He said state boards will only investigate when they receive a complaint.“There are bad actors out there, purporting to be compounding pharmacies that are licensed in specific states or have the credentials to be able to compound when in actuality they don’t,” said Carter. “My understanding is most licensed, legitimate pharmacies aren’t compounding” weight-loss medications. ‘Compounded’ weight-loss drugs are a growing problem for state regulators – https://stateline.org/2024/07/08/compounded-weight-loss-drugs-are-a-growing-problem-for-state-regulators/

A website sold patients obesity drugs at affordable rates. Now they’re paying the price.– https://www.npr.org/2025/02/08/nx-s1-5246124/a-website-sold-patients-obesity-drugs-at-affordable-rates-now-theyre-paying-the-price

“The two main goals of the medication are weight loss and diabetes management, so patients should stay on the lowest dosage possible until they feel like they’ve plateaued,” said Charu Sawhney, DO, MPH, an internal medicine physician with Harbor Health in Round Rock, Texas. When patients move up on the dosage too fast, they’re going to have more trouble, said Sawhney. “This is when we see the most severe side effects like the malnutrition and dehydration that can sometimes land patients in the hospital,” she said. Considerations for Prescribing GLP-1s Get More Complicated – Medscape – February 07, 2025 – https://www.medscape.com/viewarticle/considerations-prescribing-glp-1s-get-more-complicated

I admit as a Former Fat Man that the world of obesity and now a miracle drug to fight the disease fascinates the hell out of me. Caveat emptor!

GLP-1 – Compounded or Brand-Name?

/ SupremeCmdr / Leave a comment

Caroline Apovian, MD, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, Boston.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

GLP-1 Prescribing Decisions: Compounded or Brand-Name? – Medscape – November 14, 2024 – https://www.medscape.com/viewarticle/glp-1-prescribing-decisions-compounded-or-brand-name-2024a1000krd?

To be clear, all of my GLP-1 posts are not anti-pharma. If you can afford these medications and they work for you on your weight loss journey that’s great. Just be aware of the possible side effects and the fact these medications are for life. You will regain all that you’ve lost if you stop taking the drug.

Here’s the link to Complications? What Complications? (just another GLP-1 receptor agonist post)

Mind the Gaps – Update 11.10.24

/ SupremeCmdr / Leave a comment

More good news since I posted Mind The Gaps.

On November 5, the US Food and Drug Administration (FDA) updated the labels for all glucagon-like peptide 1 receptor agonists (GLP-1 RA) with a warning about pulmonary aspiration during general anesthesia or deep sedation. The affected drugs are semaglutide (Ozempic, Rybelsus, Wegovy); liraglutide (Saxenda, Victoza); and the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 tirzepatide (Mounjaro, Zepbound). FDA Updates GLP-1 Label With Pulmonary Aspiration Warning – Medscape – November 06, 2024. https://www.medscape.com/viewarticle/fda-updates-glp-1-label-pulmonary-aspiration-warning-2024a1000k84?src=rss

Interesting potential side effect. This is from the FDA on regulated GLP-1 RA drugs. But since I know a lot of you out there are using the compounded version…

https://www.medscape.com/s/viewarticle/novo-nordisk-aware-10-deaths-compounded-weight-loss-drug-2024a1000k8f?src=rss

Death is also a potential side effect of the FDA regulated version.

Susan McGowan, 58, took two low-dose injections of tirzepatide, known under the brand name Mounjaro, over the course of about two weeks before her death on 4 September.Her death certificate, seen by the BBC, lists multiple organ failure, septic shock and pancreatitis as the immediate cause of death – but “the use of prescribed tirzepatide” is also recorded as a contributing factor…There have been 23 suspected deaths linked to semaglutide in the UK via the yellow card scheme since 2019. Nurse’s death linked to approved weight-loss drug – https://www.bbc.com/news/articles/cz6jg6nw2zeo?

Yikes.

Telehealth Company Cerebral Agrees to pay $3.7M fine (and found guilty of nothing)

/ SupremeCmdr / Leave a comment

Telehealth company Cerebral has agreed to pay a fine of more than $3.6 million for allegedly attempting to boost prescriptions of Adderall and other controlled substances, the Department of Justice and Drug Enforcement Administration said Monday. 

Regulators allege Cerebral’s initial visit metric didn’t consider medical literature or whether prescriptions would be clinically appropriate for patients. The company also used financial incentives to spur providers to meet prescribing metrics — and even considered disciplinary measures for those who hadn’t prescribed enough stimulants for ADHD patients, according to a press release.

https://www.healthcaredive.com/news/cerebral-controlled-substance-prescribing-fine-doj-dea/732108/

This company agreed to a fine it was unable to pay so the regulators deferred payment.

Huh?

Mind The Gaps

/ SupremeCmdr / Leave a comment

The Food and Drug Administration is warning consumers not to use any drugs made by a compounding pharmacy in California after regulators realized the pharmacy was making drugs that need to be sterile—particularly injectable drugs—without using sterile ingredients or any sterilization steps.

The products made by the pharmacy, Fullerton Wellness LLC, in Ontario, California, include semaglutide, which is intended to mimic brand-name weight-loss and diabetes drugs Wegovy and Ozempic. Fullerton also made tirzepatide, which is intended to mimic weight-loss and diabetes drugs Zepbound and Mounjaro. Drugmaker shut down after black schmutz found in injectable weight-loss drug — https://arstechnica.com/health/2024/11/drugmaker-shut-down-after-black-schmutz-found-in-injectable-weight-loss-drug/

I’ve read the FDA advisory. The FDA warns patients and health care professionals not to use compounded drugs from Fullerton Wellness — https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-compounded-drugs-fullerton-wellness

  1. If you’re injecting what you believe is a weight loss medication do you pay any attention to who the manufacturer is?
  2. Do you read any of the FDA drug alerts and statements?
  3. The FDA names the compounding facility but does not name of any clinics or online purveyors who may be selling you tainted and non-sterile drugs.
  4. If you ask your online provider questions will you get honest answers?
  5. Is losing a few pounds worth the risk?
  6. Have you considered the possibility that the side effects you’re having are not just normal side effects from a GLP-1 type compounded drug and may be from an impure product?

Yikes.