This is the industry that Pres Trump is going after to lower our Rx Prices

This is a single example of where the $$ goes that the pt hands over at the Rx counter. If anyone has noticed, all of sudden the PBM industry is now advertising on TV claiming how much money they are saving people.

 

When I first started working in a pharmacy back in the summer of 1968. There was no PBM industry, and 90 %+ of all prescriptions were BRAND NAME, and the average Rx price was in the $4-$5 range. The PBM industry came around at the end of 1969. Today, 85 % + of Rxs are generics, and 85 % of Rxs are paid for by PBMs. The average Rx price today is in the $70 range.  If the PBM industry had not gotten involved in the prescription business, and nothing had changed, the average Rx price would be around $40. If we just had the change of brand names to generics at the same percentages, the average Rx price would probably be in the $25-$30 range. Just imagine if we didn’t have the PBM to save us money and require prior authorizations, mandatory generic substitution, step therapy, day’s supply limitations, and numerous other things that do nothing to improve a pt’s therapy and QOL.

Pharmacogenomics – the core of individualized precision medication therapy.

Pharmacogenomics – the core of individualized, precision medication therapy.

For the pts who are having a difficult time getting their pain managed properly. Having your PGx (DNA) testing done. The test is from a simple cheek swab.  Send it off to the lab, and in a couple of weeks, you will typically get a somewhat semi-vague report.  The report that you will first get can be as much as 70 +/- pages, listing some general plus or minuses comparing your CYP-450 liver enzymes with your medications and gives you some recommendations about how your body metabolizes the medications that you take. The graphic to the right is what a medical professional will work with to help them narrow down which particular medication in a particular category will work best with your CYP-450 liver enzymes, and your body will metabolize a particular med best.

An example is that Hydrocodone has to be metabolized to its active metabolite, which is Hydromorphone. If your body poorly metabolizes Hydrocodone, you are not going to get very good pain management.

Some prescribers do not believe in this system. The MME and Narxcare do not take PGx into consideration when determining a pt’s most appropriate dose. Most insurance companies don’t want to pay for PGx testing because they don’t see how it is going to increase their bottom line. Most don’t care if it improves the pt’s QOL.


Pharmacogenomics (PGx) is the study of how a patient’s genetic makeup influences their response to medications, with the goal of personalizing therapy to maximize benefit and minimize harm. The science and clinical application of PGx have advanced rapidly, and there is now strong evidence that proper use of PGx recommendations can significantly improve patient outcomes—especially for those with complex or high-acuity health issues.


What Is Behind the PGx System and Evaluations?

  • Core Principle:
    PGx focuses on identifying genetic variations—especially in genes encoding drug-metabolizing enzymes (like CYP450 family), drug transporters, and drug targets—that affect how drugs are absorbed, metabolized, and act in the body178.

  • Testing and Interpretation:
    PGx testing analyzes a patient’s DNA for variants (polymorphisms) in key pharmacogenes. Results are interpreted using evidence-based guidelines (e.g., CPIC, DPWG) that link specific genotypes to drug dosing, efficacy, and risk of adverse drug reactions (ADRs)92312.

  • Actionable Recommendations:
    Recommendations may include dose adjustments, drug selection, or enhanced monitoring based on the patient’s genotype-predicted phenotype (e.g., poor, intermediate, normal, or ultra-rapid metabolizer)18.


Evidence for PGx Improving Patient Outcomes

  • Reduced Adverse Drug Reactions:
    Multiple large studies and systematic reviews show that PGx-guided therapy reduces clinically significant ADRs. For example, the PREPARE trial (n=6,944) found a 33% lower risk of ADRs in patients receiving genotype-guided therapy compared to standard care136.

  • Improved Efficacy:
    PGx testing helps select the right drug and dose, increasing the likelihood of therapeutic success, especially in fields like psychiatry, cardiology, and oncology81411.

  • Cost Savings:
    PGx-guided therapy can lead to substantial cost savings by reducing ineffective prescribing, ADRs, and hospitalizations. Studies report annual savings of $600–$4,000 per patient, even after accounting for test costs46.

  • Clinical Guidelines and Implementation:
    The Clinical Pharmacogenetics Implementation Consortium (CPIC) and other expert groups provide graded, evidence-based recommendations for dozens of drug-gene pairs, supporting integration into routine care932.


Who Benefits Most from PGx?

  • High-Acuity and Complex Patients:
    Patients with multiple comorbidities, polypharmacy, or a history of ADRs benefit most from PGx, as they are at higher risk for drug-gene and drug-drug interactions4510.

  • Elderly and Those with Chronic Conditions:
    PGx can be especially valuable for elderly patients and those with chronic or rare diseases, as their medication regimens are more likely to be affected by genetic variability105.

  • Patients Requiring High-Risk Medications:
    For drugs with narrow therapeutic indices or high risk of toxicity (e.g., warfarin, codeine, certain antidepressants and antipsychotics), PGx-guided prescribing can be lifesaving814.


Summary Table: PGx Benefits

Benefit Area Evidence/Outcome
ADR reduction 30–33% lower risk of ADRs in PGx-guided groups136
Improved efficacy Higher rates of therapeutic success, especially for complex regimens811
Cost savings $600–$4,000 per patient per year46
Polypharmacy management More targeted therapy, fewer drug interactions4510
High-acuity patients Greater benefit due to complexity and risk105

Conclusion

PGx recommendations, when properly implemented, are supported by robust evidence—including large randomized trials and real-world studies—for improving medication safety, efficacy, and cost-effectiveness. The more complex the patient’s health issues and medication regimen, the greater the potential benefit from PGx-guided therapy. This approach is increasingly recognized as a key component of precision medicine and is being integrated into routine clinical practice worldwide111314.

  1. https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/508/IB10-1721_PGx_Provider_IntoToPrecisionMedicine_P97138.pdf
  2. https://pmc.ncbi.nlm.nih.gov/articles/PMC10233068/
  3. https://pmc.ncbi.nlm.nih.gov/articles/PMC5117674/
  4. https://pmc.ncbi.nlm.nih.gov/articles/PMC4725634/
  5. https://pmc.ncbi.nlm.nih.gov/articles/PMC8975737/
  6. https://www.ajmc.com/view/pharmacogenomics-for-improved-outcomes-and-decreased-costs-in-health-care
  7. https://www.genome.gov/about-genomics/educational-resources/fact-sheets/pharmacogenomics
  8. https://www.ccjm.org/content/87/2/91
  9. https://cpicpgx.org/guidelines/
  10. https://www.nature.com/articles/s41397-021-00260-6
  11. https://www.news-medical.net/news/20250526/Integrating-pharmacogenomics-into-everyday-clinical-practice-can-transform-patient-care.aspx
  12. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2023.1189976/full
  13. https://www.nature.com/articles/s41397-024-00326-1
  14. https://www.bps.ac.uk/getmedia/b43a3dca-1bbf-4bff-9379-20bef9349a8c/Personalised-prescribing-full-report.pdf.aspx
  15. https://www.genomicseducation.hee.nhs.uk/genotes/knowledge-hub/introduction-to-pharmacogenomics/
  16. https://pmc.ncbi.nlm.nih.gov/articles/PMC7696803/
  17. https://www.nature.com/articles/s41576-022-00572-8
  18. https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.3704
  19. https://pmc.ncbi.nlm.nih.gov/articles/PMC3351041/
  20. https://www.mayo.edu/research/centers-programs/center-individualized-medicine/patient-care/pharmacogenomics/patients
  21. https://www.jax.org/education-and-learning/clinical-and-continuing-education/clinical-topics/genetic-testing/pharmacogenomic-communication
  22. https://pmc.ncbi.nlm.nih.gov/articles/PMC3299179/
  23. https://pmc.ncbi.nlm.nih.gov/articles/PMC6789586/
  24. https://guidelines.carelonmedicalbenefitsmanagement.com/pharmacogenomic-testing-2024-10-20-updated-2025-04-01/
  25. https://www.medben.com/pharmacogenomics-spend-outcomes/
  26. https://pmc.ncbi.nlm.nih.gov/articles/PMC7868558/
  27. https://www.pharmacytimes.com/view/pharmacogenomics-the-vanguard-of-precision-medicine
  28. https://pubmed.ncbi.nlm.nih.gov/40399951/

Why is the MT Medical Board determined to deny many intractable chronic pain pts their necessary medication?

The Montana Medical Board has been chasing Mark Ibsen for nearly 10 yrs. Their first attempt was a complaint from a Chiropractor who worked in Mark’s “doc in a box” practice. The AG of Montana at the time, I got the impression that he would have been happy if Montana were a “opioid desert”. I am told that the Chiropractor filed a complaint with the board that he was prescribing too many opioids. Many other practices were being raided and shut down, and Mark was trying to help those pts, who had been thrown to the curb. He was trying to lower or wean their doses down, but he found that ~ 20% were ultra-fast metabolizers. Mark spent a lot on legal fees and kept pushing the medical board back. The Medical Board’s aggressive posture cost Mark so much in legal fees that he ended up closing his practice.

A couple of years ago, Mark decided to provide pain management to what he called “opioid refugees”. Using the rules that the DEA created during the COVID-19 pandemic, virtual office visits would be permitted, and prescribers could prescribe controlled medications under those guidelines.

Now the Medical Board has an attorney – probably the State AG to call for a Grand Jury to investigate Mark. The date of this Grand Jury is July 23, 2025. Of course, it is claimed that a Grand Jury could indict a “ham sandwich”. That may be because a Grand Jury is just a judge, a jury, and the prosecuting attorney. 

IMO, if this Grand Jury finds “probable cause” that Mark is violating some law by treating these “opioid refuges “, and pulls his medical license. It will be a “death sentence” to all the intractable chronic pain pts that Mark has been trying to manage their intractable chronic pain pts and optimize their QOL.

How many patients will die from being thrown into cold turkey withdrawal, or commit suicide? It is anyone’s guess. But the primary function of all medical boards is to protect the public’s health & safety. Unfortunately, no one is involved in how this all shakes out, will not have any culpability for the adverse outcomes of their decisions.


A grand jury is a legal body primarily responsible for determining whether there is probable cause to believe that a crime has been committed and whether criminal charges should be brought against a suspect167. It serves two main functions: investigatory and accusatory (charging)125.

Investigatory Function

  • The grand jury can investigate potential criminal conduct by subpoenaing documents and witnesses, reviewing evidence, and hearing sworn testimony25.

  • This investigatory power allows the grand jury to gather information independently of the prosecution, although in practice, the process is usually guided by the prosecutor25.

Accusatory (Charging) Function

  • After reviewing the evidence, the grand jury decides whether there is enough evidence (probable cause) to formally charge a person with a crime. This formal charge is called an indictment13567.

  • If the grand jury finds insufficient evidence, it can issue a “no-bill,” and no charges are brought15.

Additional Features

  • Grand jury proceedings are conducted in secret to encourage witness cooperation, protect the reputation of individuals not indicted, and allow jurors to deliberate without outside influence357.

  • The grand jury does not determine guilt or innocence; it only decides whether there is enough evidence to proceed to trial2710.

  • In the U.S. federal system, a grand jury typically consists of 16 to 23 members, and an indictment requires the agreement of at least 12 jurors56.

  • The grand jury acts as both a “shield” against unfounded or oppressive prosecutions and a “sword” to bring charges where warranted25.

In summary, the grand jury’s function is to review evidence presented by the prosecution, investigate as necessary, and decide whether there is probable cause to formally accuse someone of a crime, thereby protecting citizens from unwarranted criminal charges while enabling legitimate prosecutions to move forward12567.

  1. https://www.justice.gov/jm/jm-9-11000-grand-jury
  2. https://www.mololamken.com/knowledge-What-Exactly-Is-a-Grand-Jury
  3. https://www.findlaw.com/criminal/criminal-procedure/how-does-a-grand-jury-work.html
  4. https://www.santacruzcountyca.gov/grndjury/gjfunction.htm
  5. https://en.wikipedia.org/wiki/Grand_jury
  6. https://www.uscourts.gov/court-programs/jury-service/types-juries
  7. https://www.nyjuror.gov/pdfs/hb_grand.pdf
  8. https://courts.ca.gov/courts/jury-service/civil-grand-jury
  9. https://www.tdcaa.com/journal/grand-jury-where-the-community-meets-the-law/
  10. https://miamisao.com/wp-content/uploads/2020/12/Florida-Grand-Jury-Handbook.pdf

TO OUR FRIENDS AND FOLLOWERS:
WITH LETTER WRITING – CALLING – EMAILING – TEXTING
AND POSTING (The Montana Board monitors Dr Ibsen’s FB page)
… many of us participated in KILLER-OUTREACH resulting in
Mark’s “case” with the MT Board of Medical Examiners being
DISMISSED February 21, 2025.
Please consider being a part of this latest effort as Mark has been summoned (subpoenaed) to appear at a Grand Jury July 23, 2025.
I request that anyone willing to volunteer being a “PATHFINDER”
send me your names + phones – to shedancedwithowls@gmail
Pathfinders will take on locating 10 others who will coordinate together their OUTREACH efforts. Outreach is most impactful when it occurs more than once from an individual – so officials see that you are not a one-off.
IF you do not want to be a Pathfinder, then as an individual sending me your telephone – will have you be in a group that will get OUTREACH ideas sent to you.
For this campaign – it is essential that your OUTREACH be about Dr. Ibsen and the physician/patient relationship you have with him. OR if you are not his patient – then what you have learned about his efforts.
Please do not message me on FB; I am not reliably checking those. I am asking all of us to take our energy which we have put into postings and instead take what you would have posted and turn it into OUTREACH to an official – media – medical board – or other.

The Importance of Men’s Health Month

The Importance of Men’s Health Month

https://www.lifespan.org/lifespan-living/importance-mens-health-month

At every stage of life, men are encouraged to consider three equally important aspects of their health—physical health, mental health and social connection. Men’s Health Week and Men’s Health Month raise awareness of how these aspects work together and remind men to take charge of their health.

What is Men’s Health Week?

National Men’s Health Week was established in 1994 as a special campaign to help educate men, boys and their families about the importance of positive health attitudes and preventive health practices. Today, the week is observed around the world as International Men’s Health Week and begins on the Monday before Father’s Day in June and ends on Father’s Day itself.

The aims of the week are to heighten awareness of preventable health problems for males of all ages, to support men and boys to engage in healthier lifestyle choices and to encourage the early detection and treatment of diseases like cancer, heart disease and depression.

What is Men’s Health Month?

Men’s Health Month in the United States is observed every June. This month aims to raise awareness of the same health concerns of Men’s Health Week but lasts the whole month. It is different from Movember, which is held in November and focuses on men’s mental health as well as prostate cancer. During the month of June, men are encouraged to set goals for their own health and wellness and begin to create a roadmap for achieving those goals.

The physical aspect of men’s health

Men 15-65 years of age are significantly less likely than women to seek preventive care services, and they are more likely to report not having a primary care provider. A good first step on the path toward improved health is to make a call and establish with a primary care provider (PCP). A PCP will review medical, surgical and family history and recommend age- and risk-appropriate health screenings.

Recommended screenings for young men (18-39)

Men in this age range are encouraged to discuss the health concerns below with their doctors. These discussions can be part of a yearly annual wellness visit. While you may think you don’t need some of these tests, establishing a base line can be useful for continued health monitoring as you age, or as more acute health concerns arise.

  • Physical exam: check blood pressure, screen for obesity and assess body composition (waist circumference). Testicular exam and testicular self-exam are important at this age.
  • Metabolic screening: fasting blood sugar and fasting lipid profile based on risk and family history.
  • Vaccines: influenza, COVID-19, Hepatitis A/B, HPV, Tdap and MMR should be considered.
  • STI screening: HIV, Hepatitis B/C, syphilis, gonorrhea and chlamydia screening should be considered, and pre-exposure prophylaxis for HIV (PreP) should be discussed.
  • Assessment of risky behaviors: discuss any use of tobacco, alcohol, recreational drugs, anabolic steroids, as well as use of seatbelts and helmets and gun safety.
  • Family planning: “pre-conception” counseling to educate men that adopting a healthy lifestyle—exercising, eating healthy foods, and avoiding substances—at an early age improves the chances of conceiving and having a healthy pregnancy and a healthy child.

Recommended screenings for adult men over 40

These screenings are similar to those recommended for younger men but start to look at health concerns that most often appear in middle age. 

  • Physical exam: check blood pressure, screen for obesity, measure body composition and consider prostate exam (in some cases).
  • Metabolic screening: fasting blood sugar and fasting lipid profile and estimation of cardiovascular risk.
  • Vaccines: influenza, covid-19, Hepatitis A/B, HPV (through age 45), Tdap and MMR. Shingles vaccine is recommended for adults over 50.
  • STI screening: HIV, Hepatitis B/C, syphilis, gonorrhea and chlamydia screening should be considered, and pre-exposure prophylaxis for HIV (PreP) should be discussed. 
  • Cardiovascular screening: based on risk and symptoms (may include stress testing or coronary artery calcium score).
  • Cancer screening: based on family history and personal risks. May include prostate, colon and lung cancer screening as well as skin exam.
  • Eye exam.

Recommended screenings for adult men over 65

Older men should continue to evaluate their health and make lifestyle changes based on conversations with their doctors to ensure they are able to live life to the fullest.

  • Physical exam: blood pressure, height and weight, waist circumference and prostate exam.
  • Metabolic screening: fasting blood sugar, fasting lipid profile, thyroid function (in some cases).
  • Vaccines: influenza, covid-19, Hepatitis A/B, Tdap, Pneumovax/Prevnar and Shingles.
  • STI screening: based on risk.
  • Cardiovascular screening: abdominal ultrasound, coronary artery calcium score and stress testing based on risk and symptoms.
  • Cancer screening: prostate, colon and lung as well as skin exam.
  • Osteoporosis: screening should be considered in men over 70, men who lose height over time or have a low impact fracture. Fall risk assessment should be completed.
  • Eye exam.

The American Urology Association has published a Men’s Health Checklist with a detailed description of recommended health screenings for men of all ages.

A complete list of recommended adult vaccinations is available from the Centers for Disease Control.

Men’s Mental Health

Mental health is an important determinant of overall health and quality of life at every age. Although men are more likely to suffer “deaths of despair” including alcoholism, overdose and suicide, they are far less likely than women to seek out mental health services. Undiagnosed and untreated mood disorders in young men are associated with impaired learning, risk-taking behaviors, use of substances and violence. Adult men with chronic diseases like diabetes and cardiovascular disease have worse outcomes when they also suffer from depression, and depression is associated with decreased longevity in older men.

Men should be aware of the symptoms of depression and anxiety and know when it’s time to seek help. Organizations like HeadsUpGuys, the National Black Men’s Health Network, Don’t Change Much and the Movember Foundation provide useful tips for self-care and have online self-assessment tools to help men know when it’s time to speak with a healthcare professional. Opening up about mental health and normalizing a discussion around depression, anxiety and suicide risk is something that men can do for themselves and for each other.

The Importance of Social Connection

Social connection is essential to our health and well-being, and an increasing number of Americans report loneliness and social isolation. Research shows that people who experience loneliness and isolation are at increased risk of heart disease, dementia, stroke, depression and anxiety. Lacking social connection can even increase the risk of premature death to levels comparable to smoking. On the other hand, maintaining social connection promotes better physical and mental health, eases stress and even promotes a healthier immune system. Taking simple steps like answering a phone call from a friend, inviting someone to share a meal or volunteering in your community can help you to feel connected. The US Surgeon General recently issued a first-of-its kind advisory on the epidemic of loneliness and isolation. In it, Vice Admiral Vivek H. Murthy outlines actions that we can take on a national, local and individual level to help us all stay connected.

Men’s Health Month is the perfect time to chart your course to improved health. Keep up with health screenings and listing to your body when symptoms come up. Make mental health a priority and take steps to manage stress and stay connected.

Rite Aid offloads more than 1,000 pharmacies to former rivals

At one time, Rite Aid had abt 5,000 stores, and soon they will be down to ZERO! Walgreens 10-15yrs ago was worth 100 billion dollars, and now there are rumors that they are selling the entire chain to a private equity firm. Years ago Walgreens had ~ 11,000 stores, and now they are down to abt 8500 stores. Typically, these private equity firms buy distressed companies, and they start selling off parts that are not as profitable as they would like or should be. They will cut the operating cost overhead to the bare bones and sell what is left for 2-3 times what they paid for the chain.

Most likely, whoever buys the Rite Aid stores will close them, and move the Rx files to one of their nearby stores, and close the Rite Aid stores.  In two or three years, we will probably see similar things happening to what is left of the Walgreens chain.

How many more pharmacy deserts will be created by all this “consolidation”?

Arkansas has passed a new law that prohibits PBM from owning pharmacies. CVS which owns the largest PBM Caremark, is threatening to close 23 stores they have in Arkansas.

Pres Trump is going after our Rx meds so that our Rx meds are the lowest prices sold to any nation on the planet. The term for this is “favored nation status”.

We have so many middlemen within our healthcare system that a lot of other countries don’t have. Since the 5 largest PBM are owned by the 5 largest insurance companies. This is going to be one hell of a legal battle between TWO GOLIATHS.

Rite Aid offloads more than 1,000 pharmacies to former rivals

The pharmacy chain is undergoing a bankruptcy process to sell “substantially all of its assets.”

https://www.retailbrew.com/stories/2025/05/19/rite-aid-offloads-more-than-1-000-pharmacies-to-former-rivals

After filing for bankruptcy earlier this month for the second time in less than two years, Rite Aid Corporation is offloading more than 1,000 pharmacies to rivals such as CVS and Walgreens as well as grocery chains such as Albertsons and Kroger.

In a press release, Rite Aid CEO Matt Schroeder said that the goal of transactions is to ensure continuity of care during the bankruptcy process; the company emphasized that all pharmacies will remain open through the transition to provide prescription refills and immunizations without interruption. 

“These agreements ensure our pharmacy customers will experience a smooth transition while preserving jobs for some of our valued team members,” he said.

Warm welcomes: On the receiving end of the deal, Albertsons is giving Rite Aid customers a warm welcome—as well as a coupon. New customers are set to receive a “$15 off” coupon for their next grocery purchase, plus another coupon for every five subsequent prescriptions.

“As a community health partner, our dedicated pharmacists are committed to providing our customers with timely, safe and convenient access to medications and essential vaccines,” Anthony DalPonte, president of pharmacy and health at Albertsons, said in a statement.

CVS similarly promised it was working toward a “seamless” transition for Rite Aid customers in a blog post.

The US Bankruptcy Court will hold a hearing on Wednesday to approve the sales.

All or nothing: While Rite Aid’s first bankruptcy in 2023 aimed to optimize the chain’s footprint and restructure its debt, the Chapter 11 bankruptcy initiated on May 5 will help facilitate the sale of “substantially all of its assets.” Anything not sold during this process, per bankruptcy steward Kroll, will no longer be owned or operated by Rite Aid.

The bankruptcy comes as a difficult time for the pharmacy business. Earlier this spring, private equity firm Sycamore Partners took Walgreens private in a $23.7 billion after a rocky run on public markets.

LMAO 05312025

Walgreens to Pay $300 Million in Unlawful Opioid Prescriptions Settlement

This is another situation with the DOJ making ALLEGATIONS, and the settlement amount is based on Walgreens’ ability to pay. Maybe because all these ALLEGATIONS and settlements with DOJ and the PBMs’ low-balling reimbursements, Walgreens is most likely on the verge of declaring bankruptcy. 10-15 yrs ago Walgreens’ stock was worth ~100 billion, but they are in talks to sell the company to Sycamore Partners, a private equity firm, for ~ 10 billion.

The SCOTUS ruled in July 2024 https://www.pharmaciststeve.com/is-the-overturning-of-the-chevron-doctrine-a-good-or-bad-thing/    that federal agencies cannot create new interpretations of laws they are in charge of enforcing. It is also illegal for people/pts to obtain controlled substances under false pretenses, but there is nothing in this article of any of these people, who DOJ stated had illegal Rxs filled, being charged? What about all those illegal prescriptions? Walgreens didn’t fill them; their employee pharmacists filled them. I can’t count the number of pts that have told me that a chain pharmacist refused to fill a controlled med Rxs, and they filed a complaint with the chain HQ and were told, “We can’t force a Pharmacist to fill a Rx.”

Here is what perplexity.ai says about an allegation vs filing charges against someone/company. Maybe that is because it is a known fact that 90 – 95 %+ of people/companies taken to federal court will be found GUILTY! 

An allegation by the Department of Justice (DOJ) that a company has violated a law is not the same as formally charging the company with violating that law.

An allegation is an assertion or claim that a company has engaged in illegal conduct. It is essentially an accusation, which may be made during the course of an investigation or in public statements, but it does not in itself initiate formal legal proceedings against the company

. The DOJ may make such allegations as part of a civil investigation, in a press release, or in correspondence with the company.

A charge, on the other hand, is a formal legal action. In the context of criminal law, this typically involves the filing of an indictment, information, or criminal complaint, which are official documents that initiate a criminal case and set out the specific laws the company is accused of violating

. Only after such a document is filed does the company face formal criminal prosecution. For civil matters, a charge may take the form of a lawsuit or civil complaint.

The process generally works as follows:

  • The DOJ (or another law enforcement agency) investigates and may make allegations based on evidence gathered.

  • If the DOJ believes there is sufficient evidence, it may proceed to formally charge the company, which involves filing official documents in court

In summary, an allegation is a claim or accusation, while a charge is a formal step in the legal process that brings the accused company into court to answer the alleged violation

Walgreens to Pay $300 Million in Unlawful Opioid Prescriptions Settlement

https://jamanetwork.com/journals/jama/fullarticle/2834868

Walgreens has agreed to pay the US government $300 million in a settlement of allegations that the pharmacy chain illegally filled millions of invalid prescriptions for opioids and other controlled substances, the Department of Justice (DOJ) announced.

The civil lawsuit against Walgreens and its subsidiaries, filed in January, alleges that the drugstore chain violated the Controlled Substances Act and False Claims Act by accepting invalid prescriptions and seeking payment for them from federal health care programs including Medicare. According to the complaint, pharmacists allegedly dispensed prescriptions despite “clear red flags”—including opioid prescriptions filled significantly early, in large quantities, and in regularly abused combinations—and faced pressure from the company to fill prescriptions quickly without taking time to ensure legality.

The settlement amount is based on Walgreens’ ability to pay, the DOJ stated. If the company is sold, merged, or transferred prior to 2032, it will owe the US an additional $50 million. On top of the monetary payments, Walgreens has entered into agreements with the Drug Enforcement Administration and the Department of Health and Human Services Office of Inspector General to ensure future compliance with laws regulating the distribution of controlled substances.

A similar lawsuit against pharmacy giant CVS is still pending.

What Medicaid Cuts Mean for Chronic Pain

What Medicaid Cuts Mean for Chronic Pain

Untreated childhood pain follows to adulthood

https://www.medpagetoday.com/opinion/second-opinions/115803

As pediatric pain psychologists, we often wish we had a magic wand that could wave away the suffering that children and their families bring into our offices. However, we know that good pain management for kids isn’t magic. It’s science. And it depends first and foremost on access to consistent, high-quality healthcare.

People are often shocked to learn that they have probably known a child with chronic pain. In fact, one in five children and adolescentsopens in a new tab or window suffer with chronic pain during their youth, making chronic pain one of the most common and overlooked disorders in childhood. Yet, for these millions of children with recurring pain, there are less than 60 pediatric pain centersopens in a new tab or window in the U.S. Pain scientists and clinicians have worked tirelessly to build these truly lifesaving programs. Still, even with years of effort, the scale of need so vastly outweighs the available resources that most families will never gain access. And now, proposed cuts to Medicaid threaten to make the situation even worse.

We meet the families that are lucky enough to access care in clinic every day. Children often arrive to their first appointments with limited physical functioning and must relearn how to move their bodies. Some show up with mobility devices and a goal of walking without assistance; others are striving to re-learn how to socially function, regulate pain-related fear, or just develop habits that help their bodies learn to sleep well at night again. Pain science has made all of these goals realistic for the majority of kids who can access good care.

Without Medicaid support, however, many children will continue to have limited functioning and difficulty returning to their lives. For the fortunate families who are able to access pediatric pain treatment centers, the results are often observed by parents to be miraculous.

For example, consider a 16-year-old female athlete who arrived at her first appointment in a wheelchair. She had difficulty getting out of bed and walking independently. She described her pain as unbearable — a feather touch to the skin yielding fiery discomfort. She had missed more school than she had attended over the past year. Her parents had to shift job schedules to take care of her. Basketball team texts became MyChart appointment reminders. The family’s whole life was engineered to fit the agenda of pain. Fortunately for this family, they were able to access an interdisciplinary team of trained pain specialists, including pain medicine physicians, pain psychologists, physical therapists, and occupational therapists. As a team, these providers were able to offer evidence-based treatment to help this athlete return to the classroom, to her sports, to her friends, and ultimately, to herself. The family could rebuild their life after 6 months of pain rehabilitation.

This is just one example of the many children we see whose lives have been twisted beyond recognition because of a chronic pain syndrome. For the family mentioned above, they were able to receive early intervention and make steady progress. However, this is not the case for families who get access to the right care too late, or never get access at all. When patients do not receive early intervention, they can develop severe chronic pain. Treatment becomes a slow and arduous march, sometimes taking months to years of therapies before a child and their family can recover functioning. It is our collected decades of experience working in the trenches with these children and families that drives our plea to ensure pediatric pain treatment is not luxury care. It is evidence based, life-altering recovery.

Children’s lives and futures are at risk right now. Without Medicaid, children will lose access to treatments like ours that quite literally give them their lives back. The proposed federal budget cutsopens in a new tab or window to Medicaid will deepen the gap between what kids need and what families can access. If we allow that to happen, we aren’t just ignoring suffering — we’re ensuring it.

Here’s the rub: ensuring childhood pain isn’t only about kids; it ensures another generation of adults with serious pain conditions. That is a reality we are intimately familiar with in this country. Childhood pain that goes untreated or undertreated is one of the strongest predictors of chronic pain in adulthood. We’ve lived through one opioid epidemic — one born in part from our failure to offer strong, early solutions for pain. If we cut off access now, we’re not just abandoning children in pain — we may be setting the stage for some version of an Opioid Epidemic 2.0. And with it, an even larger burden on our future workforce, healthcare system, and economy.

To be sure, children with private insurance will still have access to high-quality pain care, but Medicaid is the backbone of all pediatric healthcare in the U.S., covering nearly half of all childrenopens in a new tab or window. Approximately 37 million childrenopens in a new tab or window in the U.S. are enrolled in Medicaid or the Children’s Health Insurance Program (CHIP), and Medicaid accounts for more than $4 billionopens in a new tab or window in pediatric pain-related healthcare per year. In many pediatric pain programs, Medicaid is the most common payor. While Medicaid is administered through the individual states, federal funding matches at least 50%opens in a new tab or window of what states contribute. Without federal funds, fewer children will have access to pain care; though their symptoms will remain, and likely amplify over time.

We are asking you to please call your legislators. Urge them to protect Medicaid funding and remove cuts. Pediatric pain care isn’t optional. For the children and families we serve — some of whom may also be your patients, or perhaps even your children, grandchildren, nieces, nephews, and neighbors, and the youth who will one day be charged with carrying forward our society — it’s essential, life-changing care.

Withholding pain management – a type of TORTURE?

 

The article below is just the first page of a 5-page article, and the hyperlink below will bring up the entire article

2011.12 InterRights Bulletin Article_only

 

 

 

 

 

 

 

 

 

Journavx: not suitable for chronic pain or the most severe acute pain cases

Overview of Vertex’s New Acute Pain Medication: Journavx (Suzetrigine)

Vertex Pharmaceuticals’ Journavx (suzetrigine) is a newly FDA-approved, first-in-class, non-opioid oral medication for moderate-to-severe acute pain, such as that experienced after surgery or injury1231014. It represents the first new class of acute pain therapy in over 20 years and has generated significant interest among clinicians and patients seeking alternatives to opioids123912.


Professional Reviews

Efficacy and Clinical Trial Results

  • Journavx demonstrated statistically significant pain reduction compared to placebo in two pivotal phase 3 trials involving patients undergoing abdominoplasty and bunionectomy1101114.

  • The drug did not outperform the opioid combination of hydrocodone and acetaminophen (Vicodin) but did provide effective pain relief without opioid risks61314.

  • Median time to meaningful pain relief was 2 hours for abdominoplasty and 4 hours for bunionectomy, compared to 8 hours for placebo11.

  • Clinical experts, including pain specialists, describe Journavx as “compelling” and a “potential game-changer,” especially for filling the treatment gap between NSAIDs/acetaminophen and opioids14712.

  • The Institute for Clinical and Economic Review (ICER) found the evidence for net health benefit compared to non-systemic therapies to be split among reviewers, but acknowledged the drug’s potential to reduce opioid use disorder and its societal costs5.

Safety Profile

  • Journavx was generally well tolerated in clinical trials, with fewer adverse events than placebo in some studies1314.

  • Most common side effects included itching, muscle spasms, elevated creatine phosphokinase, and rash61011.

  • Contraindicated with strong CYP3A inhibitors and grapefruit products due to drug interactions61011.

Limitations and Concerns

  • Journavx is only approved for short-term (acute) pain, not chronic pain, although studies are ongoing for chronic indications3714.

  • Its analgesic strength is described as “weak” compared to opioids, making it suitable primarily for moderate-to-severe acute pain but not for the most severe cases61314.

  • Cost is a significant concern: $15.50 per pill or about $31 per day, much higher than generic opioids, which may limit insurance coverage and patient access248.

  • Some experts remain cautious, noting that more long-term safety and efficacy data are needed, and that it is too early to definitively declare the drug non-addictive258.


Patient Feedback

Reported Experience

  • In a phase 3 trial, over 83% of patients rated Journavx as “good,” “very good,” or “excellent” for pain relief after surgery or other acute pain events14.

  • Patients appreciated the non-opioid option, especially those concerned about addiction or unable to tolerate opioids3614.

  • Some patient organizations and advocates note that while the pain relief is meaningful, it may not be as strong as what some patients expect from opioids, and it is not suitable for chronic pain or the most severe acute pain cases67.

Side Effects

  • Most patients tolerated the drug well, with mild side effects such as itching and muscle spasms being the most common61011.

  • No reports of euphoria, dependence, or withdrawal have emerged in clinical trials, supporting its non-addictive profile so far23714.


Summary Table: Journavx (Suzetrigine) vs. Opioids for Acute Pain

Feature Journavx (Suzetrigine) Opioids (e.g., Hydrocodone)
Mechanism NaV1.8 sodium channel inhibitor Mu-opioid receptor agonist
Addiction Risk No evidence so far High
Efficacy (vs. Placebo) Superior Superior
Efficacy (vs. Opioids) Inferior or similar Superior
Most Common Side Effects Itching, muscle spasms, rash Nausea, constipation, sedation
Cost (per day) ~$31 <$1 (generic)
Insurance Coverage Uncertain, may be limited Broad
Approved Use Acute pain only Acute and chronic pain

Bottom Line

  • Journavx (suzetrigine) is a promising, non-opioid option for moderate-to-severe acute pain, offering effective relief without the risk of addiction associated with opioids12314.

  • It is not as potent as opioids and is not approved for chronic pain, but it fills a critical gap for patients who need more than NSAIDs/acetaminophen but want to avoid opioids461314.

  • High cost and insurance barriers may limit widespread adoption, and long-term safety and real-world effectiveness remain under review2458.

  • Both professionals and patients are cautiously optimistic, with many describing it as a significant advance in pain management, though not a “silver bullet” for all pain scenarios23712.

Citations:

  1. https://www.neurologylive.com/view/fda-approves-vertex-pharmaceuticals-suzetrigine-acute-pain-management
  2. https://www.biopharmadive.com/news/vertex-pain-non-opioid-drug-fda-approval-journavx/738721/
  3. https://www.nbcnews.com/health/health-news/fda-approves-new-type-nonopioid-painkiller-acute-pain-rcna189871
  4. https://www.biospace.com/drug-development/vertexs-journavx-changes-the-pain-treatment-landscape-but-opioids-here-to-stay
  5. https://icer.org/news-insights/press-releases/institute-for-clinical-and-economic-review-publishes-final-evidence-report-on-treatment-for-acute-pain/
  6. https://rsds.org/a-new-pain-killer-on-the-market-the-good-and-the-not-so-good-on-journavx/
  7. https://psyclarityhealth.com/hopeful-new-non-addictive-pain-relief-by-vertex/
  8. https://www.biopharmadive.com/news/pain-drug-vertex-opioid-price-insurance-journavx/738856/
  9. https://www.pharmexec.com/view/fda-approves-vertex-pharmaceuticals-first-class-non-opioid-journavx-moderate-severe-acute-pain
  10. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain
  11. https://www.drugs.com/journavx.html
  12. https://cen.acs.org/pharmaceuticals/drug-development/FDA-approves-new-nonopioid-pain-medication-hailed-a-triumph/103/web/2025/01
  13. https://www.statnews.com/2025/01/30/vertex-pain-drug-journavx-wins-fda-approval-non-opioid/
  14. https://www.cnbc.com/2025/01/30/fda-approves-vertex-non-opioid-painkiller-drug.html
  15. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class
  16. https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-advancements-suzetrigine-vx-548-acute-and
  17. https://www.definitivehc.com/resources/healthcare-insights/most-common-pain-medication
  18. https://www.thepharmaletter.com/icer-evidence-report-on-vertex-new-treatment-foraacute-pain
  19. https://www.vrtx.com/stories/state-pain-america/
  20. https://www.reddit.com/r/ChronicPain/comments/1japyo2/ive_got_journavx_suzetrigine_in_my_hand_filled/
  21. https://www.biopharmadive.com/news/vertex-pain-drug-data-lumbosacral-radiculopathy-lsr-stock/736055/
  22. https://www.statnews.com/2024/12/19/vertex-chronic-pain-sciatica-suzetrigine/
  23. https://www.thepharmaletter.com/vertex-phase-2-suzetrigine-study-disappoints

Answer from Perplexity: pplx.ai/share