Profits not People

Mind the Gaps – Update 11.10.24

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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)

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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

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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.

Cannabis and Impaired Brain Development

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The adolescent brain is particularly vulnerable to cannabis, especially today’s higher-potency products, which put teens at risk for impaired brain development; mental health issues, including psychosis; and cannabis use disorder (CUD).  That was the message delivered by Yasmin Hurd, PhD, director of the Addiction Institute at Mount Sinai in New York, during a May 6 press briefing at the American Psychiatric Association (APA) 2024 annual meeting. 

“We’re actually in historic times in that we now have highly concentrated, highly potent cannabis products that are administered in various routes,” Hurd told reporters. Tetrahydrocannabinol (THC) concentrations in cannabis products have increased over the years, from around 2%-4% to 15%-24% now, Hurd noted. High-Potency Cannabis Tied to Impaired Brain Development, Psychosis, CUD – Medscape – May 13, 2024. https://www.medscape.com/viewarticle/high-potency-cannabis-tied-impaired-brain-development-2024a1000935

Earlier posts on this topic:

Marijuana is Too Strong (THC turbocharged)

Cannabis Use and Psychosis Risk

Cannabis Use and Psychosis Risk (Aussie Version)

Reefer Madness

Marijuana is Too Strong (THC turbocharged)

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For some, it can be dangerous. In the past few years, reports have swelled of people, especially teens, experiencing short- and long-term “marijuana-induced psychosis,” with consequences including hospitalizations for chronic vomiting and auditory hallucinations of talking birds. Multiple studies have drawn a link between heavy use of high-potency marijuana, in particular, and the development of psychological disorders, including schizophrenia, although a causal connection hasn’t been proved. “It’s entirely possible that this new kind of cannabis—very strong, used in these very intensive patterns—could do permanent brain damage to teenagers because that’s when the brain is developing a lot,” Keith Humphreys, a Stanford psychiatry professor and a former drug-policy adviser to the Obama administration, told me. Humphreys stressed that the share of people who have isolated psychotic episodes on weed will be “much larger” than the number of people who end up permanently altered. But even a temporary bout of psychosis is pretty bad. Marijuana Is Too Strong Now – https://www.theatlantic.com/ideas/archive/2024/08/high-potency-marijuana-regulation/679639/

Cannabis Use and Psychosis Risk (Aussie Version)

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Professor Emmerson says Queensland’s Metro North Health — Australia’s largest public health service, based in north Brisbane and the surrounding region — is seeing increased presentations of psychosis due to medicinal cannabis.”The Metro North early psychosis service reports 10 per cent of their new presentations — so these are kids aged 16 to 21 — are people who’ve ended up on medicinal cannabis and are becoming psychotic,” the Brisbane-based psychiatrist says.

Doctors warn of significant increase in people hospitalized with psychosis after being prescribed medicinal cannabis — https://www.abc.net.au/news/2024-07-21/medicinal-cannabis-psychosis-harm-risk-prescription-marijuana/104116952

Hallucinogenic Drugs at a Gas Station Near You!

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Newly released testing data of Diamond Shruumz-brand gummies purchased in 2023 identified the presence of psilocin, a hallucinogenic drug closely related to the magic-mushroom drug psilocybin that is classified as a Schedule I drug, alongside psilocybin, heroin, and LSD. The finding comes as Diamond Shruumz’s current line of gummies, chocolates, and candy cones is being recalled and are under active investigation in connection to a nationwide rash of severe illnesses, which have involved seizures, intubation, and intensive care. As of the latest update on July 15, 69 people in 28 states have been sickened after eating a Diamond Shruumz product. Sixty of the 69 sought medical care, 36 were hospitalized, and there is one potentially associated death under investigation. Illegal drug found in Diamond Shruumz candies linked to severe illnesses — https://arstechnica.com/science/2024/07/illegal-drug-found-in-diamond-shruumz-candies-linked-to-severe-illnesses/

I’ll stick with my gas station beers, thanks.

Cannabis Use and Psychosis Risk

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The investigators found that cannabis use was significantly associated with psychotic disorders during adolescence (adjusted hazard ratio [aHR], 11.2; 95% CI, 4.6 to 27.3), but not during young adulthood (aHR, 1.3; 95% CI, 0.6 to 2.6). Adolescents who used cannabis also had a substantially higher risk for hospitalizations and emergency department visits (aHR, 26.7; 95% CI, 7.7 to 92.8), while there was no substantial risk observed in young adulthood (aHR, 1.8; 95% CI, 0.6 to 5.4). Growing Evidence Supports the Link Between Cannabis Use and Psychosis Risk — https://www.psychiatryadvisor.com/news/cannabis-use-and-psychosis-risk/

Have you read the book The Dangerous Truth About Today’s Marijuana by Laura Stack? https://johnnysambassadors.org/book/

If you have small children I highly recommend this book.