Interesting concept – opioid free surgery – pt’s choice & can always drop out of the program

PROGRAMS TO BE USED

AI PROGRAMS:

www.perplexity.ai

https://claude.ai/new

https://chatgpt.com/

https://x.com/i/grok


Send Faxes using a computer

https://www.pcmag.com/picks/the-best-online-fax-services#


OPEN OFFICE software

https://www.openoffice.org/

Open Office software refers to a free and open-source office productivity suite developed as an alternative to commercial office software like Microsoft Office. Originally known as OpenOffice.org, it was created from the StarOffice suite and was open-sourced by Sun Microsystems in 2000. Today, its main version is Apache OpenOffice, run by the Apache Software Foundation.wikipedia+2

Main Features

Apache OpenOffice includes six main applications:

  • Writer: A word processor (similar to Microsoft Word)

  • Calc: A spreadsheet program (similar to Excel)

  • Impress: Presentation software (like PowerPoint)

  • Draw: Vector graphics editor

  • Base: Database management program

  • Math: A formula editor for mathematical equationsopenoffice+2

Key Advantages

  • Completely free to download, use, and distribute—no purchase or license fees.

  • Cross-platform: Works on Windows, Mac, Linux, and more.

  • OpenDocument file format (ODF): Uses an open standard for storing data, and can read most Microsoft Office files.

  • Open-source development: Anyone can contribute or report bugs, leading to a transparent development process.

  • Multilingual and widely supported: Available in over 100 languages.openoffice+2

Usage

OpenOffice is used for everyday office tasks: writing documents, creating spreadsheets, making presentations, drawing diagrams, managing databases, and writing mathematical formulas. Its familiar layout makes it easy for users coming from other office suites to adapt quickly.

Note

Active development of Apache OpenOffice has slowed, and an offshoot called LibreOffice is now more frequently updated and is widely recommended for those seeking the latest features.wikipedia+2

In summary, Open Office software provides a comprehensive, no-cost solution to everyday office tasks, with full compatibility for common file types and wide community support.techtarget+2

  1. https://en.wikipedia.org/wiki/OpenOffice.org
  2. https://www.openoffice.org/why/
  3. https://www.openoffice.org
  4. https://en.wikipedia.org/wiki/Apache_OpenOffice
  5. https://www.openoffice.org/product/
  6. https://www.techtarget.com/searchenterprisedesktop/definition/Apache-OpenOffice
  7. https://openoffice.apache.org
  8. https://www.youtube.com/watch?v=6iUJPy1cj7E
  9. https://www.youtube.com/watch?v=XnUsTyQtZ20
  10. https://www.reddit.com/r/computers/comments/1e66n6t/which_one_is_better_microsoft_office_or_open/

 

This is a good example of BUYER BE WARE!


Lilly has a mail order pharmacy that will fill prescriptions for all strengths of Zepbound in vials for < $500 for 4 weeks.

https://www.lilly.com/lillydirect/medicines/zepbound

You only have one LIFE and one QOL!  As soon as the lawsuits start stacking up because they are basically selling an illegal compound product. They will file bankruptcy and close their doors and VANISH.

 

FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss

https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

Understanding unapproved versions of these drugs

FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs, including semaglutide and tirzepatide, as an option for weight loss. This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed.  

FDA recommendations for patients 

  • Patients should obtain a prescription from their doctor and fill the prescription at a state-licensed pharmacy.  
  • Visit FDA’s BeSafeRx campaign for resources to safely buy prescription medicines online.  
  • Talk to your doctor if you have questions about your medicines.  

Concerns with compounded versions of these drugs 

A compounded drug might be appropriate if a patient’s medical need cannot be met by an FDA-approved drug, or the FDA-approved drug is not commercially available. However, compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.   

The agency has identified some areas of concern for compounded GLP-1 drugs. FDA is working with its state regulatory partners and will continue to communicate with compounders regarding these concerns.

Fraudulent compounded GLP-1 drugs 

FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label. In some cases, the compounding pharmacies identified on the labels of the products do not exist. In other cases, the labels of the fraudulent compounded medicine contain the name of a licensed pharmacy that, based on information FDA has gathered, did not compound these products.

FDA is aware of one reported adverse event associated with a product labeled as compounded tirzepatide from a pharmacy that did not actually compound the product. The adverse event report included symptoms such as redness, site swelling, pain, and a red lump at the injection site.

Recommendations for consumers

The agency encourages patients to be vigilant and know the source of their medicine. 

  • Carefully check labels of compounded GLP-1 drugs for warning signs such as spelling errors or incorrect addresses and ensure your medicine is provided by a licensed pharmacy and prescribed by a licensed health care provider.
  • If you receive a product with a licensed pharmacy name on the label that you think might be fraudulent, contact the pharmacy to ask if it is their product. 
  • Talk to your doctor if you have questions about your medicines.

Dosing concerns with compounded semaglutide and tirzepatide 

FDA received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products. These dosing errors resulted from patients measuring and self-administering incorrect doses of the drug, and in some cases, health care professionals miscalculating doses of the drug.  

Additionally, the agency has received adverse event reports that may be related to patients prescribed compounded semaglutide or tirzepatide products in doses beyond what is in the FDA-approved drug label. This could mean using more product in a single dose, taking doses more frequently or increasing the amount more quickly (titration schedule). Some of the adverse events are serious and some patients reported seeking medical attention for their symptoms, including nausea, vomiting, diarrhea, abdominal pain and constipation. 

Health care providers should be vigilant when prescribing compounded semaglutide or tirzepatide products and determining appropriate doses and titration and dosing schedules for patients. The agency also encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide or tirzepatide. 

Retatrutide and cagrilintide cannot be used in compounding

Retatrutide and cagrilintide cannot be used in compounding under federal law. Additionally, these are not components of FDA-approved drugs and have not been found safe and effective for any condition.

Salt forms should not be used to compound semaglutide 

The agency is aware that some semaglutide products sold by compounders may be the salt forms. These salt forms, including semaglutide sodium and semaglutide acetate, are different active ingredients than are used in the approved drugs. The agency does not have information on whether these salts have the same chemical and pharmacologic properties as the active ingredient in the approved drug, and we are not aware of any lawful basis for their use in compounding.  

Adverse events related to compounded versions of semaglutide and tirzepatide  

FDA has received reports of adverse events related to compounded versions of semaglutide and tirzepatide. However, federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA so it is likely that adverse events from compounded versions of these drugs are underreported. Many of the adverse events reported for compounded products appear to be consistent with adverse events related to the FDA-approved versions of these products.  

As of July 31, 2025, the FDA has received: 

  • 605 reports of adverse events associated with compounded semaglutide.
  • 545 reports of adverse events associated with compounded tirzepatide.

It is not always possible to determine if the adverse event directly resulted from use of the drug or if other factors may have contributed to these adverse events. 

Illegally marketed versions of these drugs 

Counterfeit Ozempic

FDA is aware of counterfeit Ozempic marketed in the U.S. Counterfeit drugs claim to be authentic, but could contain the wrong ingredients, contain too little, too much or no active ingredient at all or other harmful ingredients, and are illegal. 

The agency investigates reports of suspected counterfeit drugs to determine the public health risks and the appropriate regulatory response. FDA remains vigilant in protecting the U.S. drug supply from these threats.   

Illegal online sales of these drugs

FDA monitors the internet for fraudulent or unapproved drugs and has issued warning letters to stop the distribution of illegally marketed semaglutide and tirzepatide. These illegally marketed drugs:

  • may be counterfeit
  • could contain the wrong ingredients or harmful ingredients
  • could contain too little, too much or no active ingredient at all 

The agency urges consumers to be vigilant when purchasing drugs online and only purchase from state-licensed pharmacies.  

Versions sold falsely for research purposes or not for human consumption 

FDA has warned companies that have illegally sold unapproved drugs containing semaglutide, tirzepatide or retatrutide that are falsely labeled “for research purposes” or “not for human consumption.” These products have been sold directly to consumers for human use with dosing instructions. The agency urges consumers not to purchase these products which are of unknown quality and may be harmful to their health.  

Reporting issues to FDA

FDA encourages health care professionals, patients and compounders to report adverse events or quality problems with these or any medications to FDA’s MedWatch Adverse Event Reporting program:

  • Complete and submit the report online, or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.

You also may contact the CDER Division of Drug Information at druginfo@fda.hhs.gov or 855-543-3784.

There are NO LEGAL FENTANYL TABLETS THEY ARE ALL ILLEGAL FENTANYL TABS

I count EIGHT TIMES that the word FENTANYL is mentioned in this pretty short press release by the DEA. AND NOT ONCE do they state that they are talking about ILLEGAL/ILLICIT Fentanyl analogs. That could  contain not only an illegal Fentanyl analog but could also contain various other drugs, a couple of veterinarian meds, illegal Cocaine, Methamphetamine, Marijuana, etc, etc.  If they are showing illegal Fentanyl tablets that they confiscated – there is no Fentanyl tablets produced by our legal Pharmaceutical companies and so any/all substances that is claimed to be a Fentanyl product, could contain a cornucopia of various illegal drugs. 

Also, I have read that all the illegal drugs that the DOJ/DEA confiscate, is only 12%-15% of what actually gets to our streets and the number of people lives they claimed that they have saved by confiscating all the illegal drugs they did. You can multiply that number by 7 to 8 as the potential real numbers of people that could get poisoned/OD’s by what got to our streets.

The DEA has been fighting the WAR ON DRUGS since 1973, and the real numbers seem to be that they have successfully denied more chronic pain pts from getting their necessary medications, than the number of illegal drugs that are killing our fellow citizen on our streets.

 

CVS Caremark continues to flout West Virginia law

Maybe this explains why the CVS Health net profits are substantially increasing each year when other pharmacies are having trouble just paying their bills. Rite Aid just declared their last bankruptcy and closing their last 1000 stores. Walgreen is selling the company to some financial group.

The West Virginia Office of the Insurance Commissioner (OIC) issued a $1.4 million fine to CVS Caremark based on 2,871 violations of several provisions of the 2021 Pharmacy Audit Integrity Act. The OIC said CVS Caremark improperly applied the definition of “rebate” when withholding rebate payments and fees from the health plan, recouped excessive funds from pharmacy claims relative to the financial harm associated with the dispensed products, and exceeded the maximum number of prescriptions covered in a pharmacy audit.

The company also delivered contracts and communications to providers that cited fees associated with the cost of pharmacy audits in excess of those allowed by law and unreasonably designated 65 covered prescription medications as specialty drugs.

The commissioner ordered CVS Caremark to file a plan to address the violations within 30 days and is allowing 90 days to implement it. In the meantime, CVS Caremark requested a stay of the penalty order through the state’s Supreme Court of Appeals. The OIC previously fined CVS Caremark for reimbursing pharmacies below the required commercial market benchmark of NADAC plus the state Medicaid program’s professional dispensing fee.

Does Sec Kennedy have a clue of the 100+million chronic pain pts will never be able to participate in MAHA

Is PAM BONDI/DOJ/DEA AGENDA diametrical opposed to Sec Kennedy’s MAHA (Make American Healthy Again) agenda?  Some 25%-30% of our population has had their QOL continuing deterioration over the last decade. How can that population have any chance of getting healthy again and optimized their QOL, if the intensity of their chronic pain has been increasing because of DOJ/DEA has been constantly intimidating practitioners to prescribe fewer and fewer pain meds along with making the pharmas production quotas >50% less over the last decade. 

Sec  Kennedy is in charge of MAHA (Make America Healthy Again). My money is on that this woman who posted the text below, he doesn’t have a clue about this woman or probably millions of chronic pain pts that are suffering/dying out of sight – out of mind. She is also one of millions that will never be able to attempt to GET HEALTHY AGAIN. All wars have their COLLATERAL DAMAGE, How many tens of millions of chronic pain pts are/have been collateral damage of the war on drugs that has turned into pretty much a COVERT GENOCIDE?

This is suppose to be RFK,Jr’s secretary’s email:  OSA11y@hhs.gov

Robert F. Kennedy Jr. arrives to testify before the Senate Finance Committee during a confirmation hearing on his nomination to be Secretary of Health and Human Services on Jan. 29, 2025, in Washington, DC.

I want to thank you for everything you and Dr Ibsen do for the pain community. You are an amazing human being. A couple of weeks ago I couldn’t take it anymore. I felt like the pain was getting worse and I got sicker. I became homeless and that was the last straw for me. I decided to end my life. I don and cannot do this anymore and if it wasn’t for the stupid cleaning lady at the hotel I would have succeeded I spend time in the ICU and then in a horrible mental ward, then back on the street. My dignity was taken from me. I now have a roommate and thought I would get back on track. But my health won’t hear of it. I have on top of AA cellulitis in both of my lower extremities, kidney stones and a couple of days ago a Merda diagnosis. The spores are in my body. I was send home with four antibiotics that are killing my body as well as Ibuprofen and Tylenol for the stones. I can’t walk far anymore and have given up I wrote a letter for you and Mark should something happen to me. Please, get it to a newspaper. I know I am asking much but I don’t have anyone who would do that for me. Please continue to support those patients and Mark, keep fighting. I love you both, thank you from the bottom of my heart.

OpenEvidence says its AI model has scored a perfect 100% on the United States Medical Licensing Examination (USMLE)

OpenEvidence AI scores 100% on USMLE as company launches free explanation model for medical students

https://www.fiercehealthcare.com/ai-and-machine-learning/openevidence-ai-scores-100-usmle-company-offers-free-explanation-model

Artificial intelligence startup OpenEvidence says its AI model has scored a perfect 100% on the United States Medical Licensing Examination (USMLE), raising the bar on the proficiency of AI models to interpret medical information.

The company spent the last six months evolving the core AI models and other technologies that power OpenEvidence and training a more advanced reasoning model, Daniel Nadler, Ph.D., founder of OpenEvidence, told Fierce Healthcare. The company’s AI models had scored a 90% on the USMLE two years ago.

“The models can actually reason step by step and do what I would call a second or third derivative reasoning, which means not just taking the fact that comes in before you, but taking the factors in before you, figuring out what those imply, and then reasoning through the implications,” he said, noting that OpenEvidence’s AI models have achieved “super high-grade medical reasoning.”

The USMLE is a three-step exam that is required for medical licensing in the U.S., with each step evaluating different aspects of whether a doctor has the knowledge and skills to provide safe and effective medical care.

Nadler asserts that what is key to this development is that OpenEvidence is offering a new AI system that not only accurately answers each question on the USMLE but also teaches the reasoning behind each answer.

The company is rolling out an explanation model that demonstrates the reasoning behind the correct answers as a free medical education resource. The models provide accurate references using gold-standard sources of medical knowledge such as The New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA), the company said.

Nadler said the new AI explanation models and other tools will help “democratize” access to quality medical education resources and support.

OpenEvidence developed an AI-powered medical search engine and generative AI chatbot exclusively for doctors that summarizes and simplifies evidence-based medical information. Founded in 2022 by Nadler, the company touts that it’s the most widely used medical search engine among U.S. clinicians, claiming more than 40% of physicians in the U.S. use its platform.

The company offers its chatbot to physicians for free. It is actively used across more than 10,000 hospitals and medical centers nationwide, and it continues to grow by more than 65,000 new verified U.S. clinician registrations each month, the company claims.

OpenEvidence has formed strategic content partnerships with the American Medical Association, the NEJM, the JAMA and all 11 JAMA specialty journals including JAMA Oncology and JAMA Neurology. The startup has raised more than $300 million since its founding, including a $210 million series B raise last month, at a $3.5 billion valuation.

The new AI explanation model will be available for free for physicians with a national provider identifier and professionals with a medical education number, Nadler said.

These tools were built “with a focus on education, creating vignette and case-based learning customizable by training level with reasoning and explanations grounded in the current medical literature,” according to the company. It demonstrates OpenEvidence’s commitment and continued effort to improve physician knowledge at all levels of medical education.

“There’s an enormous amount of inequality in medical education in the United States and in preparation for medical school exams,” Nadler noted, as the cost of medical school education continues to rise.

With the launch of the free medical education tools, Nadler says he is coming full circle as he worked at test prep company Kaplan while he was in school.

“Those who could pay for very expensive high-grade test prep tended to do better on the test because they had people like me walking them through the explanations of the answer,” he said. “I’ve seen the direct value of seeing an explanation for an answer. An explanation of why an answer is the correct answer is so critical in helping someone prepare and study for a test and to learn the body of knowledge. The point is not just to pass the test. The point is to learn it.”

With advancements in AI and its increasing use in healthcare, AI companies and researchers have been evaluating the performance of AI models on medical exams to test their proficiency with medical knowledge and interpretation. AI’s performance on medical exams has significantly improved over time. In late 2022, a study found that OpenAI’s ChatGPT was able to score at or close to the 60% passing grade needed for the USMLE. Later that year, researchers evaluated ChatGPT-4 on USMLE Step 1-style questions, and it answered 86% of the 1,300 questions accurately.

OpenAI’s latest model, ChatGPT-5, scored a 97%, according to OpenEvidence’s evaluation, Nadler said.

Back in April, biomedical informatics researchers at the University of Buffalo said a clinical AI tool they developed demonstrated improved accuracy on all three parts of the USMLE. The tool, called Semantic Clinical Artificial Intelligence (SCAI), scored as high as 95.1% on Step 3 of the USMLE, notably outperforming GPT-4 Omni, which scored 90.5% on the same test, according to a paper published in JAMA Network Open.

However, testing AI on medical exams is just one benchmark. Many industry experts say argue that many of these evaluations focus heavily on question-answer tests and not enough on evaluating real-world medical tasks.

Microsoft’s AI team recently released a paper that evaluated how well AI diagnosed medically complex cases from the NEJM as compared to doctors. That paper looked at Microsoft’s AI-enabled diagnostic system, called the Microsoft AI Diagnostic Orchestrator (MAI-DxO), and found it can accurately diagnose up to 85% of complex medical cases, a rate more than four times higher than a group of experienced physicians.

Nadler agrees that a USMLE score is not the best way to evaluate OpenEvidence in a clinical context.

“I think this is just strictly applicable to helping future doctors really prepare for and understand the answers to the USMLE,” he said. “What we’re actually much more proud of is the ability to reason out and explain step by step why something is the right answer. I think there’s a lot of value there. This, to me, is much closer to medical intelligence.”

Health tech and AI companies are racing to expand their footprints in healthcare and to be the go-to tools for doctors in medical decision support. Just last week, Doximity bought Pathway Medical for $63 million to bulk up its healthcare AI capabilities as it looks to offer more free AI tools to doctors. Pathway claims it has one of the largest structured data sets in medicine, “spanning nearly every guideline, drug and landmark trial across all major specialties.”

Earlier this year, Pathway said its AI models top the publicly reported leaderboard on the USMLE, achieving a 96 % accuracy rate. At that time, Pathway said it outperformed other medical‑AI systems such as GPT‑4, Med‑Gemini, OpenEvidence and Hippocratic AI.

Now, there’s a legal feud as OpenEvidence sued Pathway for trade secret theft earlier this year alleging the company “invaded the OpenEvidence AI platform repeatedly and executed dozens of ‘prompt injection’ attacks.”

OpenEvidence filed a similar suit against Doximity in June.

The FDA & state boards of pharmacy have no cojones nor a backbone

It is the FEDERAL LAW, if a patented Rx med is unavailable or in short supply, then compounding pharmacy can compound the Rx med as long as the med is unavailable or there is a shortage. The shortage of the GLP-1 injectables have been readily available for months.

From what I have read, the FDA has sent these compounding pharmacies letter to cease and desist. Both Nova & Lilly has sued these companies and if any state Board of Pharmacy has taken any action – revoking their pharmacy license – I have not seen any of the media covering it.

What I have read is these compounding pharmacies at not using the exact same medication/ingredient that is being put in the commercial product. Also, Zepbound is the only GLP-1 medication that works on both GLP-1 receptor and the GIP receptor and “they” are working on a medication that will work on the last and third receptor. Lilly also sells Mounjaro which is the same as Zepbound, but specifically FDA approved for treating Diabetes type-2

I have also read that these compounded pharmacy’s products share some serious side effects with the commercial products, but more frequently than the commercial products.

Lilly has for some time been offering their Zepbound in vials and all strengths via their arrangement with a mail order pharmacy and all strengths are <$500 for 4 vials. That is about HALF of the price of the auto-injector.  Here is the link to their mail order service  https://www.lilly.com/lillydirect/medicines/zepbound

Zepbound (tirzepatide) injection Single-dose Vial 15 mg/0.5 mL

 

Despite FDA ruling, compounded GLP-1s are still giving Novo and Lilly headaches on the market

https://www.pharmavoice.com/news/fda-ruling-compounded-glp-1s-novo-nordisk-eli-elilly/757841/

Copycat weight loss drugs were supposed to be pulled from the market, but pharmacies have found a loophole.

When the FDA took Novo Nordisk and Eli Lilly’s GLP-1 medications off of the drug shortage list, the move should have been a death knell for copycat compounded versions. But then something unexpected took place. 

Compounding pharmacies found a loophole and continued making off-brand versions of the lucrative weight loss drugs. Months later, compounded GLP-1s are still for sale on direct-to-patient platforms like Hims & Hers

Compounded drugs, which are not FDA approved, are allowed on the market when the brand-name medications are in shortage or when patients need personalized versions. When Novo and Lilly’s drugs were in short supply last year, compounded GLP-1s were also sold at a significantly lower cost for those paying out of pocket. 

But once the shortage was over, the FDA gave compounding pharmacies a grace period before it planned to crack down. Now, with the grace period long over, compounding pharmacies still operate by making their GLP-1s “personalized,” with slight changes to formulas. It’s a strategy some experts have described as a regulatory failure

The compound drug issue has hit Novo particularly hard.

Earnings impact

During its second-quarter earnings call with analysts, Novo executives noted that compounded GLP-1s are impacting uptake for Wegovy prescriptions and the stunting the overall growth of the branded obesity market this year.

“Multiple entities continue to market and sell compounded GLP-1s under the false guise of personalization, and it is estimated … around 1 million patients are on compounded GLP-1s in the U.S.,” said David Moore, president of Novo Nordisk and executive vice president of U.S. operations. 

At the same time, Novo has been grappling with tougher competition from Lilly, whose share of the obesity market rose to 57% as of the second quarter.

The compounding market is also becoming more complex. Several telehealth platforms that offer compounded GLP-1s have partnered with Lilly or Novo to offer their branded weight loss drugs. For example, health and fitness platform Noom partnered with Lilly’s direct-to-patient platform LillyDirect earlier this year to sell vials of Zepbound. However, Noom also launched low doses of compounded semaglutide this month starting at $119 per month — about a quarter of the cost for the branded drug’s starting dose.

The microdoses may reduce the impact of side effects from semaglutide use, which have caused many patients to abandon the treatments

“We set out to virtually eliminate side effects for the vast majority, so that more than 70% of people would encounter no side effects,” Dr. Jeffrey Egler, chief medical officer at Noom, said in a statement. “In both my clinical experience and evidence in published studies, it is clear that many people discontinue GLP-1 treatment because of side effects.”

Lilly said in June it would only partner with telehealth platforms that agree not to sell compounded GLP-1s.

Novo’s DTC channel offers vials of Ozempic for about half the list price of its injectable pens. But compounded versions are taking too much share from this out-of-pocket option, diminishing Novo’s quarterly results and financial outlook, executives said this month.

“As unsafe and unlawful mass compounding continues, the Wegovy penetration within the cash channel has been lower than expected,” Moore said on the earnings call.

New lawsuits

Lilly and Novo maintain that personalized compounded GLP-1s are running afoul of the law, and both have launched new lawsuits in an attempt to prohibit pharmacies from selling the products. The companies also argue that compounded GLP-1s put patients at risk.

Novo filed 14 new lawsuits this month against medical spas, telehealth platforms and compounding pharmacies, alleging the “unapproved knockoffs” of Wegovy are made with illegal APIs and are not safe. The suits also allege companies are violating the law by influencing doctors to steer patients toward the compounded versions.

“This is a priority for our company. This is a priority to protect patient safety. This is a priority to ensure that the laws are followed,” Moore said of the lawsuits during the earnings call. 

Moving forward, Moore also said “there is nothing categorically that is off the table” with respect to the litigation. He also said Novo has increased dialogue with the FDA to put more pressure on companies that are “misleading patients” with the compounded GLP-1s.

The FDA recently updated its warning about unapproved, compounded GLP-1s, calling them “risky.”

FDA Approves First-in-Class Drug for Fibromyalgia

Personally, I always thought of Fexeril as a fairly “crappy” med.  One time we were at our FL beach condo and I had stressed or pulled a muscle and I went to a local “doc in a box” and he gave me #15 of Flexeril 10 mg, could not persuade him to give me a “better muscle relaxant”. Out of desperation, I had it filled. I took the first dose, and after one hr +/- I got up from the futon I was lying on and took a couple of steps and passed out and hit my head on our (hard)  ceramic flooring.  I was dealing with what is called orthostatic hypotension – when a pt changes positions – standing up from a seated or prone position, and the medication they are taking hinders the pt’s cardiovascular system to adjust the pt’s blood pressure to increase to maintain the pt’s “normal” blood pressure.   Needless to say, the other 14 tablets GOT TOSSED!

Tonmya (cyclobenzaprine HCl) is available as a sublingual tablet in a strength of 2.8mg. The usual dosing regimen for adults with fibromyalgia is:

Initial dose (Days 1–14): 2.8mg (1 sublingual tablet) once daily at bedtime.

Maintenance dose (Day 15 and onward): 5.6mg (2 sublingual tablets) once daily at bedtime, which is the maximum recommended dose.

For geriatric patients or those with mild hepatic impairment, the recommended and maximum dose is 2.8mg once daily at bedtime.

Estimate price for Tonmya 60 tabs/month $150-$200. Since Fibromyalgia is a CHRONIC CONDITION – Insurance/PBM will be ecstatic paying out $1,800-$2,400/month. Since this tab is designed to be placed under the tongue and not in a similar dose to any generic Cyclobenzaprine, I would expect a lot of Prior Authorization BS!

Generic Cyclobenzaprine 10 mg : max dose of 40mg 3xd price via www.single-care.com $7 to $25 for 120 doses, $84 to $300/yr.

FDA Approves First-in-Class Drug for Fibromyalgia

https://www.medscape.com/viewarticle/fda-approves-first-class-drug-fibromyalgia-2025a1000ltm

The FDA has approved cyclobenzaprine hydrochloride sublingual tablets (Tonmya, Tonix Pharmaceuticals), a first-in-class, nonopioid treatment for adults with fibromyalgia, a chronic pain syndrome that affects more than 10 million Americans, roughly 80% of whom are women.

The medication, taken once-daily at bedtime, targets nonrestorative sleep, a root cause of pain, fatigue, and brain fog in fibromyalgia. It’s the first new FDA-approved therapy for the treatment of fibromyalgia in over 15 years. Tonmya (formerly TNX-102 SL) is expected to be available in the fourth quarter of this year.

In two double-blind, randomized, placebo-controlled, phase 3 trials (RELIEF and RESILIENT) of nearly 1000 patients with fibromyalgia, sublingual cyclobenzaprine significantly reduced daily pain scores compared to placebo at 14 weeks (the primary endpoint).

In addition, a greater percentage of patients using the medication daily at bedtime experienced a clinically meaningful (≥ 30%) improvement in their pain after 3 months, compared to placebo.

Results of the RESILIENT trial were published online on July 8 in Pain Medicine.

A third phase 3 trial (RALLY) of more than 500 patients with fibromyalgia demonstrated greater but nonsignificant treatment effect with sublingual cyclobenzaprine compared to placebo.

Across all three trials, the medication was generally well tolerated with no serious side effects. The most common adverse events were local administration-site reactions including oral discomfort, dry mouth, and canker sores, as well as fatigue and drowsiness.

 

What to do when a pt survives very serious medical errors

Oh please…. many of u may have read, this past Wednesday i had a stent placed in my duodenum due to overuse of aspirin as im a pain patient, denied pain medication. Well after they installed it, i was taken to recovery where i was in literal agony an throwing up blood…. LOTS of blood. While there they gave me IV morphine. But they sent me home despita the hi pain an constant throwing up of blood. ALL OF THIS COULD HAVE BEEN AVOIDED HAD I BEEN PLACED IN PAIN MGT FROM BEGINNING. Anyway, once home, the Percocet 5mg was no way touching the level of pain an lord knows by then how much blood i lost so back to the ER we went, about 6pm. U know those green barf bags they have? I FILLED 3 of them while in ER. They let me go again, pain at agony level. So i go to sleep an at 6am, i get up to go to bathroom an blood came rushing down legs, floor in bathroom, alll over. Hubby said i lost about a pint of blood. Sooo much blood, i thought i was dying. So an ambulance was called an off i went to ER for 3rd time! Finally, they realized, im not there to get drugs an i mite actually be in danger! Long story short, they rushed me back into OR an removed the stent an spot where blood was gushing out, located. GET THIS… seems the gastro Dr installed this stent where an existing bleeding ulcer was an ripped it further plus the stent was RUBBING ON IT!!! Omg, no wonder the pain level was thru the roof! They gave me a transfusion. Well they finally kept me. Even tho the pain was greatly reduced by yanking that stent out, my poor stomach an abdomen still hurt. That nite, after they almost killed me, the SOB Dr cut a perc 5mg IN HALF, 2.5 mg an thats what they gave me!!! U would think theyd at least kept me comfortable! Still, no. I came home yesterday, limited food for 2 weeks an nothing for pain.

Im extremely ANGRY about all this. So ASK ME!! Why not ask ME, like ur article says!


The above I found on the web – a pt’s VERY BAD EXPERIENCE. Remember the 3rd largest cause of a person’s death is MEDICAL ERRORS, behind cancer & cardiovascular issues. I
I asked a AI program: It answered because I live in Indiana, but suspect that it will apply to all states:
If a pt is seriously harmed – but survived -in a hospital by an employee or a practitioner with hospital rights, who could the pt reach out to practitioner’s insurance- should they investigate the competency of the practitioner. The Joint commission for the hospital having a potential incompetent practitioner. The state insurance commissioner, the consumer protection dept of state governor – how many entities have oversight of such issues that a pt can take their concerns to: If a patient is seriously harmed in an Indiana hospital (but survives), there are several avenues and oversight bodies for addressing concerns about a potentially incompetent practitioner or unsafe conditions. Here’s a breakdown of entities a patient can contact, their roles, and related oversight mechanisms:
### 1. Hospital/Internal Complaints
– The first step is often the hospital’s **Patient Relations Department** or the Risk Manager. All hospitals should have internal procedures for investigating care concerns and practitioner competency.[1]
### 2. Indiana Department of Health (IDOH)
– Patients can file complaints about care provided in any licensed or certified healthcare facility with the IDOH, which investigates quality and safety issues.[2][3][4][5][1]
– IDOH also oversees the reporting and investigation of medical errors and adverse events that result in serious harm.[4]
### 3. Indiana Professional Licensing Agency/Medical Board
– The Indiana state **medical board** is responsible for licensing, investigating, and disciplining medical practitioners. Complaints about practitioner competency or unsafe practice are within their jurisdiction and can result in professional discipline, loss of license, or required remediation.[6][7][8]
### 4. The Joint Commission
– If the hospital is accredited by The Joint Commission, a complaint can be submitted for investigation into patient safety and care standards compliance.[9]
– The Joint Commission can initiate further investigations and require corrective actions if systemic problems are identified.
### 5. State Insurance Commissioner
– The **Indiana Department of Insurance** does not typically investigate practitioner competency but may oversee insurance issues, such as malpractice policy compliance or claim denials. Inquiries here are more appropriate for insurance-related grievances rather than care quality or safety.
### 6. Consumer Protection Office/Attorney General
– The Indiana Attorney General’s Consumer Protection Division accepts healthcare complaints, but typically those involving billing, fraud, or abusive practices—not standard-of-care issues. They may become involved if there’s deceptive or fraudulent conduct.
### 7. Peer Review Committees
– Hospitals maintain **peer review committees** that evaluate practitioner competency and investigate adverse outcomes. Findings may lead to internal corrective actions or be referred to state licensing boards.[8]
### 8. National Reporting Systems
– Some events (especially involving abuse, neglect, or criminal acts) require reporting to federal or national systems.
### Summary Table of Key Oversight Entities
| Oversight Entity | Approves/Disciplines Practitioner | Investigates Patient Harm | Accreditation/Safety Standards | Consumer Protection |
|———————————-|:——————————-:|:————————:|:—————————–:|:————————:|
| Hospital Patient Relations/Risk | Yes[1] | Yes[1] | Yes | No |
| Indiana Dept. of Health (IDOH) | Indirectly[7][5] | Yes[2][3][4] | Yes[4][5] | No |
| Medical Licensing Board | Yes[6][7][8] | Yes | No | No |
| The Joint Commission | Indirectly[9] | Yes | Yes | No |
| State Insurance Commissioner | No | No | No | Yes (insurance only) |
| Attorney General/Consumer Protect| No | No | No | Yes (fraud/deception) |
| Peer Review Committee | Yes[8] | Yes | Yes | No |
### Takeaways for a Harmed Patient
– **For serious harm possibly due to staff incompetence, patients (or family) should contact:**
– The hospital’s Patient Relations department/risk manager.
– The Indiana Department of Health.
– The Indiana Medical Licensing Board (for practitioner incompetence).
– The Joint Commission if the facility is accredited.
– The State Insurance Commissioner for insurance grievances (not for quality).
– The state Attorney General if fraud or abuse is suspected.
– **Hospitals are required to investigate internally (peer review), and practitioners are subject to oversight by state, regulatory, and accreditation bodies.**[7][1][4][6][8]
– **While multiple authorities may overlap, for care quality and practitioner competency, the IDOH and the Medical Licensing Board are the primary state oversight bodies, with additional oversight from internal committees and The Joint Commission for accredited hospitals.**