What www.perplexity.ai has to say about forced reduction of an established pt’s opioid therapy

The reduction or elimination of a patient’s long-term opioid pain management could potentially lead to legal issues for the prescriber, but the situation is complex and depends on various factors.

Prescribers who abruptly discontinue or substantially reduce opioid therapy for patients on long-term treatment may face legal risks:

1. Potential civil liability: Healthcare providers who improperly prescribe or discontinue opioids may be held civilly liable under a negligence theory if a patient is injured as a result[1].

2. Risk of patient harm: Sudden discontinuation or substantial dose reduction can cause distressing withdrawal symptoms, inadequate pain control, and potential negative consequences for the patient’s quality of life[2].

3. Duty of care: Prescribers have a responsibility to provide appropriate pain management and to follow established guidelines for opioid therapy discontinuation or reduction[3].

However, it’s important to note that:

1. CDC guidelines: The Centers for Disease Control and Prevention (CDC) has published guidelines for responsible opioid prescribing, which may support a prescriber’s decision to reduce or discontinue opioid therapy in certain circumstances[3].

2. Tapering recommendations: Opioid use should not be decreased sharply or discontinued abruptly, but should be gradually reduced through a process known as tapering[2].

3. Informed consent: Prescribers should obtain informed consent from patients, which includes discussing potential risks and benefits of treatment, as well as alternative options[3].

Regarding civil rights or ADA violations:

1. ADA considerations: If the patient’s chronic pain condition qualifies as a disability under the Americans with Disabilities Act (ADA), they may have grounds for a claim if they can demonstrate that the prescriber’s actions resulted in discrimination or failure to provide reasonable accommodations.

2. Civil rights: It’s less clear whether this situation would constitute a civil rights violation, as opioid prescribing decisions are generally considered medical judgments rather than civil rights issues.

To minimize legal risks, prescribers should:

1. Follow established guidelines for opioid prescribing and tapering.
2. Document their decision-making process and rationale for changing opioid therapy.
3. Provide alternative pain management strategies and support for patients during tapering.
4. Ensure clear communication with patients about changes in their pain management plan.

While there is potential for legal action, the outcome would depend on the specific circumstances of the case, including the prescriber’s adherence to medical standards and guidelines, the patient’s medical history, and the impact on the patient’s health and well-being.

Citations:
[1] https://www.ue.org/risk-management/health-and-well-being/avoid-liability-for-prescription-opioid-abuse-by-student-athletes/
[2] https://pmc.ncbi.nlm.nih.gov/articles/PMC6857102/
[3] https://www.ncbi.nlm.nih.gov/books/NBK572085/
[4] https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes
[5] https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2703950
[6] https://dhhs.ne.gov/DOP%20document%20library/Pain%20Management%20Pain%20Guidance.pdf
[7] https://www.azdhs.gov/documents/prevention/womens-childrens-health/injury-prevention/opioid-prevention/appendix-b-state-by-state-summary.pdf
[8] https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm


Based on the search results provided, there is limited direct evidence of clinical studies supporting the validity of the Morphine Milligram Equivalent (MME) system’s conclusions. However, some relevant information can be extracted:

1. A study identified 232,913 opioid prescriptions for 49,060 unique patients from 2008-2019, which was used to validate an MME conversion framework[1]. This framework achieved high performance (F-measure of 0.97) in converting opioid prescriptions to MME values[1].

2. The MME system is used as a tool for monitoring opioid prescribing patterns and can help healthcare systems assess the variation of MME values compared to CDC guidelines published in 2016[1].

3. MME values are considered useful for associating prescribing patterns with patient outcomes and as an indicator of overdose potential[1].

However, it’s important to note that:

1. The search results do not provide specific clinical studies validating the conclusions drawn from the MME system.

2. The concept of validity in clinical studies is generally related to a measure’s ability to record or quantify what it purports to measure[4]. The search results do not provide information on clinical studies specifically testing the validity of MME-based conclusions.

3. Clinical validation typically involves demonstrating that a tool acceptably identifies, measures, or predicts clinical, biological, physical, or functional states in a defined context of use[5]. The search results do not provide evidence of such validation for the MME system.

In conclusion, while there is evidence of the MME system being used and validated for conversion accuracy, the search results do not provide specific clinical studies supporting the validity of conclusions drawn from the MME system. Further research focusing on clinical outcomes and the predictive value of MME-based assessments would be necessary to establish stronger evidence for its validity in clinical practice.

Citations:
[1] https://pmc.ncbi.nlm.nih.gov/articles/PMC9477978/
[2] https://arxiv.org/html/2501.16688v1
[3] https://pmc.ncbi.nlm.nih.gov/articles/PMC8270512/
[4] https://mmshub.cms.gov/measure-lifecycle/measure-testing/evaluation-criteria/scientific-acceptability/validity
[5] https://www.nature.com/articles/s41746-020-0260-4
[6] https://mmshub.cms.gov/2024/2024-10/mms-information-session-research-reality-translating-reliability-and-validity-findings
[7] https://health.ec.europa.eu/document/download/9f9dbfe4-078b-4959-9a07-df9167258772_en?filename=hta_clinical-studies-validity_guidance_en.pdf
[8] https://www.ewsolutions.com/managed-metadata-environment-mme-complete-walkthrough/


Based on the search results provided, there is no evidence that the Morphine Milligram Equivalent (MME) system incorporates pharmacogenomics DNA tests in its calculations of opioid therapeutic equivalence[1][2][3].

The MME system primarily relies on fixed conversion factors for different opioids to calculate their equivalent potency in relation to morphine[1][2]. These conversion factors are standardized and do not appear to take into account individual genetic variations that might affect opioid metabolism or efficacy.

The MME calculation typically uses a simple formula:

Strength per Unit × (Number of Units / Days Supply) × MME conversion factor = MME/Day[1][7]

This formula is based on the drug strength, quantity, days supplied, and a predetermined conversion factor for each opioid. It does not include any variables that would account for individual genetic differences[1][2][3].

While pharmacogenomics is an important field in personalized medicine, particularly for pain management, the current MME system as described in these search results does not incorporate genetic testing data into its calculations of opioid equivalence.

Citations:
[1] https://legislature.vermont.gov/Documents/2018/WorkGroups/Senate%20Finance/Bills/H.386/H.386~Nolan%20Langweil~MME%20Informational%20Documents~4-13-2018.pdf
[2] https://www.cms.gov/files/document/methodology-comparison.pdf
[3] https://www.fda.gov/media/150436/download
[4] https://apps.health.ny.gov/pub/ctrldocs/bne/nyosammeformulation.pdf
[5] https://pmc.ncbi.nlm.nih.gov/articles/PMC8270512/
[6] https://www.ohiopmp.gov/med_calculator
[7] https://medicaid.utah.gov/Documents/files/Opioid-Morphine-EQ-Conversion-Factors.pdf
[8] https://www.hhs.gov/guidance/document/opioid-oral-morphine-milligram-equivalent-mme-conversion-factors-0


Answer from Perplexity: pplx.ai/share


 

Walgreens suspends dividend, breaking 90-plus year streak of shareholder payouts

Walgreen’s stock price has dropped ~ 80% over the last 5 yrs. The DOJ has been “going after” these large chains for BELIEFS that they were filling controlled Rxs for pts without a valid medical need.  As I remember this all started around 2011 – just after the Decade of Pain Law expired and not renewed.  Rite Aid is in bankruptcy with ~ 1,250 stores down from ~ 5,000 stores in 2008. CVS has stated that they are going to close 200-300 stores/yr going forward. In 2016 they peaked with > 9,600 and currently have ~ 9,150.

If one looks back to 2011 and going forward, how many times has the DOJ/DEA/State AG’s sued pharmas, wholesalers, and chain stores.  Each time, extracting multi-billion settlements for alleged violation of the CSA. It is claimed that 46% of the counties in our country has at least one area that is consider a pharmacy desert. Between 2010 & 2021, 26,145 pharmacies have closed their doors. That is SEVEN PHARMACIES A DAY CLOSING FOR 12 YEARS.

Walgreens suspends dividend, breaking 90-plus year streak of shareholder payouts

https://apnews.com/article/walgreens-suspends-dividend-stock-plunge-c1d2d0c151864821ddf04dec954039e7

Walgreens shares sank Friday, a day after the drugstore chain said it was suspending its dividend, breaking a streak of quarterly shareholder payouts that stretches back more than 90 years.

The drugstore chain said late Thursday that it made the decision in an effort to strengthen its balance sheet and improve free cash flow as company leaders try to turn around the struggling business.

Walgreens has been dealing with thin prescription reimbursement, rising costs, persistent theft and inflation-sensitive shoppers who are looking for bargains elsewhere. The company is in the early stages of a plan to close 1,200 of its roughly 8,500 U.S. locations.

The company said in a brief statement Thursday that its cash needs over the next several years for things like litigation and debt refinancing were big parts of the decision to suspend the dividend.

Earlier this month, the U.S. Justice Department filed a lawsuit in federal court accusing the drugstore chain of filling millions of prescriptions without a legitimate purpose, including some for dangerous amounts of opioids.

In September, the company said it would pay $106 million to settle separate litigation over false payment claims.

Walgreens started last year by cutting the quarterly dividend nearly in half. The company slashed the payout to 25 cents from 48 cents after spending about $1.7 billion on cash dividends in fiscal 2023.

Chief Financial Officer Manmohan Mahajan told analysts earlier this month that Walgreens still was evaluating “the appropriateness and size of our dividend as part of our capital allocation policy.”

The suspension was “prudent and somewhat overdue,” Leerink Partners analyst Michael Cherny said Thursday in a research note. He added that the divided had “become out of whack” in terms of its yield and the cash it required.

There were only two dividend suspensions last year in the S&P 500, including one from the chipmaker Intel. There generally are only a few each year.

A dividend suspension “is sending a signal to the whole world that I have a problem, and it’s cash flow and it’s not short term,” said Howard Silverblatt, senior index analyst at S&P Dow Jones Indices.

But he added that markets frequently see a dividend suspension as a positive sign initially because the company recognizes it has a problem and is taking a step to correct it.

Gabelli Funds portfolio manager Jeff Jonas said last fall that another dividend cut was likely for Walgreens.

“The balance sheet is slowly improving, but that still needs to improve further,” he said.

The company says it has paid cash dividends every quarter since 1933, a streak stretching more than 90 years or nearly 370 straight quarters.

Shares of Walgreens Boots Alliance Inc., based in Deerfield, Illinois, tumbled more than 15% to $9.66 after markets opened Friday. Broader indexes were up slightly.

The drop wiped out a brief rally the shares had after Walgreens reported better than expected earnings earlier this month. The stock has now shed more than half its value since last spring, and company shares have been on a steady decline for a decade.

FDA Approves New Class of Non-Opioid Pain Medicine for Moderate to Severe Acute Pain

abdominoplasty –commonly known as a “tummy tuck

bunionectomy surgically reduce a bony bump that forms at the base of the big toe

all participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication

Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo (SUGAR TABS/CAPS)

The application received Breakthrough Therapy, Fast Track and Priority Review designations by the FDA

According to this article, a New Class of Non-Opioid Pain MedicinesJournavx’s maker Vertex Pharmaceuticals was granted Fast Track approval.

In CONCLUSION, the med Journavx is better that placebo (sugar) doses, but pts were given Ibuprofen – no strength mentioned – for break-thru ACUTE PAIN!

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain

First Drug Approved in New Class of Non-Opioid Pain Medicines; Agency Continues to Take Steps to Support New Approaches for Pain Management

Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.  

Journavx is the first drug to be approved in this new class of pain management medicines.

Pain is a common medical problem and relief of pain is an important therapeutic goal. Acute pain is short-term pain that is typically in response to some form of tissue injury, such as trauma or surgery. Acute pain is often treated with analgesics that may or may not contain opioids.

The FDA has long supported development of non-opioid pain treatment. As part of the FDA Overdose Prevention Framework, the agency has issued draft guidance aimed at encouraging development of non-opioid analgesics for acute pain and awarded cooperative grants to support the development and dissemination of clinical practice guidelines for the management of acute pain conditions.  

“Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option. This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”

The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy. In addition to receiving the randomized treatment, all participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo.

The safety profile of Journavx is primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 participants with moderate to severe acute pain following abdominoplasty and bunionectomy, with supportive safety data from one single-arm, open-label study in 256 participants with moderate to severe acute pain in a range of acute pain conditions.

The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Journavx is contraindicated for concomitant use with strong CYP3A inhibitors. Additionally, patients should avoid food or drink containing grapefruit when taking Journavx.

The application received Breakthrough Therapy, Fast Track and Priority Review designations by the FDA.  

The FDA granted approval of Journavx to Vertex Pharmaceuticals Incorporated.

###

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

Novel Biomarkers Predict Pain Sensitivity

I have read – or someone told me – that the DEA/DOJ when they RAID a practitioner’s office.  They ask the practitioner how did they know that the pt was suffering/dealing with chronic pain. They ask for the “tests” to prove that the pt was dealing with pain, but we all know that there are no test to document that the pt has pain. Apparently the DEA works under the belief that anyone getting opioid Rxs filled routinely, are just “drug seekers”  Here is one of my recent blog post where some practitioners are attempting to create a new disease that would allow all pts taking opioids regularly could being labeled with this new “medical disorder” Prescription Opioid Use Disorder (POUD) The introduction to a NEW MEDICAL DISEASE associated with opioid uses. “We” now have pharmacogenomics that will determine – via DNA test – that a pt is a fast/ultra faster metabolism and will have a biological reason to have high and/or frequent doses. It is common knowledge that the MME system is “JUNK SCIENCE”. How many and how long is the DOJ/DEA going to be able to continue to ignore the growing number of tests, that confirms that a pt is dealing with chronic pain?

Novel Biomarkers Predict Pain Sensitivity

https://www.medpagetoday.com/neurology/painmanagement/113965

Cortical activity signature may tell who will develop chronic pain

Key Takeaways

  • A biomarker signature using brain activity measurements predicted pain sensitivity.
  • The signature combined sensorimotor peak alpha frequency and corticomotor excitability.
  • The study involved 150 people who received nerve injections to test prolonged pain.

A novel biomarker signature that assessed cortical activity predicted individual pain sensitivity, the PREDICT validation study showed.

The signature consisted of two measures: sensorimotor peak alpha frequency (PAF) and corticomotor excitability (CME). In the training set, it correctly classified study participants with high or low pain sensitivity with an area under the curve (AUC) of 1.00.

In the test set, the signature had an AUC of 0.88 (95% CI 0.78-0.99), reported David Seminowicz, PhD, of the University of Western Ontario in London, Canada, and co-authors in JAMA Neurology

Results were reproduced across a range of parameters. The PAF and CME biomarkers showed good to excellent test-retest reliability.

“The combination of biomarker accuracy, reproducibility, reliability, and pain model validity suggests high potential for clinical translation, particularly in predicting the transition from acute to chronic pain,” Seminowicz and colleagues wrote.

PAF is the dominant sensorimotor cortical oscillation in the 8-12 Hz (alpha) range. CME is the efficacy of relaying signals from the primary motor cortex to peripheral muscles. Previous work showed that slower PAF before pain onset and reduced CME during prolonged pain were associated with more pain, while faster PAF and increased CME were associated with less pain.

“Given that individuals who experience higher pain in the early stages of a prolonged pain episode (e.g., postsurgery) are more likely to develop chronic pain in the future, slow PAF before an anticipated prolonged pain episode and/or CME depression during the acute stages of pain could be predictors for the transition to chronic pain,” the researchers noted.

Identifying objective biomarkers to track pain severity has been dubbed “the holy grail” of pain neuroscience, observed Prasad Shirvalkar, MD, PhD, of the University of California San Francisco, and Christopher Rozell, PhD, of the Georgia Institute of Technology in Atlanta, in an accompanying editorial

“While pain is among the most fundamental, ubiquitous, and adaptive experiences that can befall an organism, there is still a murky understanding of how pain is generated in the nervous system,” they noted. The consensus on mechanisms underlying chronic pain — pain that persists for more than 3 months, which affects 21% of U.S. adults — is even less clear.

The PAF and CME signature “will likely have broad applicability across many medical fields,” Shirvalkar and Rozell said. “If successfully translated into clinical practice, biomarkers that predict a transition to chronic pain would have a tremendous impact for the treatment of millions of individuals.”

Advances in pain biomarkers also need to incorporate advances in global neuroethics guidance and address ethical concerns about pain treatment, the editorialists pointed out. “We must take care to ensure that quantitative measures do not supplant lived experience reports, introduce distrust in the physician-patient relationship, set unrealistic patient expectations, or exacerbate existing inequalities in pain treatment across this vulnerable population,” they wrote.

The PREDICT validation study included 150 people (100 in the training set, and 50 in the test set) who were given an injection of nerve growth factor into the right masseter muscle on day 0 and day 2 to induce prolonged jaw pain that lasted up to 4 weeks.

Participants were healthy adults recruited in Australia with a mean age of 25. They had no history of chronic pain or a neurological or psychiatric condition, and 84 participants (56%) were men.

The research aimed to determine whether individuals could be accurately classified as having high or low pain sensitivity based on baseline PAF and CME readings. The researchers used electroencephalography to assess PAF and transcranial magnetic stimulation with resulting evoked potentials to assess CME on day 0, day 2, and day 5.

The primary outcomes were jaw pain on chewing and yawning. Pain sensitivity was assessed twice daily from day 1 through day 30 through self-reported pain scores.

Seminowicz and colleagues used five machine learning models on the training set. Of these, the winning classifier was logistic regression. Including sex and pain catastrophizing as covariates did not improve model performance.

The study assessed healthy participants using an experimental pain model; results may not apply to other people or other circumstances, the researchers acknowledged.

NCPA to CMS: A Third of Independent Pharmacies Won’t Carry Drugs in the Negotiated Price Program, and 60 Percent More are Considering Dropping Out

NCPA warns CMS that many independent pharmacies won’t carry MDPN drugs

https://ncpa.org/newsroom/news-releases/2025/01/27/ncpa-cms-third-independent-pharmacies-wont-carry-drugs-negotiated

The National Community Pharmacists Association today submitted comments to the Centers for Medicare & Medicaid Services with a stern warning that more than 90 percent of independent pharmacies may decide, or have already decided, to not stock drugs in the Medicare Drug Price Negotiation Program because they will cause massive financial losses and potentially put them out of business.

“Pharmacies will have to float thousands of dollars every month waiting for refunds from the manufacturers. That will cause a massive cash flow problem in an environment where thousands of pharmacies have already closed,” said NCPA CEO B. Douglas Hoey.

In its comments, NCPA cited a recent national survey of independent pharmacists that found a jaw-dropping 93.2 percent of respondents have already decided to not stock the drugs in the program, or they are considering not stocking them.

“That will be devastating to the program,” said Hoey. “Patients who need these prescriptions will be unable to get them, because their pharmacies cannot participate in the program. It’s great the government removed big insurance’s PBMs from the negotiations and the result was lower prices for these prescription medications. That’s an important outcome for patients and taxpayers. But if almost no pharmacies can stock the drugs because they will sustain huge financial losses, the program will collapse before it even starts.”

According to the survey:

  • 60.4 percent of independent pharmacists are considering not stocking one or more of the first 10 drugs listed in the Medicare Drug Price Negotiation Program.
  • 32.8 percent of independent pharmacists have already decided not to stock one or more of the drugs listed in the Medicare Drug Price Negotiation Program.
  • 96.5 percent of independent pharmacists said PBM and plan reimbursement for Medicare Part D threatened the viability of their business.
  • 40.8 percent of independent pharmacists said they were paid below what they pay to buy the drug, approximated by the National Average Drug Acquisition Cost (NADAC), on more than 40 percent of the prescriptions they filled for Medicare Part D patients.
  • 29.2 percent of independent pharmacists said they were paid below NADAC on 50 percent or more of the prescriptions they filled for Medicare Part D patients.
  • 80.3 percent of independent pharmacists said the financial health of their business declined in 2024.
  • 48.6 percent of independent pharmacists said the financial health of their business declined significantly in 2024.
  • 30.3 percent of independent pharmacists said they are considering closing their business in Calendar Year 2025.

If CMS and the new administration want to save the program, and if they want to prevent the disappearance of many more pharmacies, they will make a number of changes, said NCPA.

Among the changes the organization proposed, CMS should bar PBMs from requiring pharmacies to participate in the program in order to serve Medicare Part D patients, and it must also give pharmacies the ability to cancel PBM contracts without cause. NCPA made many additional recommendations, which can be viewed here.

Click here to view the entire NCPA survey.

 

Online advertising of compounded GLP-1 receptor agonists often doesn’t meet federal advertising rules

Online advertising of compounded GLP-1 receptor agonists often doesn’t meet federal advertising rules

Online advertising of compounded GLP-1 receptor agonists often doesn’t meet federal advertising rules

Researchers investigated whether online sellers of compounded formulations of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) — popular diabetes control and weight loss agents — adhere to federal advertising rules. The law requires that marketing for all prescription medications, even compounded products not approved by FDA, be “truthful, non-misleading, and accurate.” To gauge the level of compliance among vendors of GLP-1 RAs, which are frequently sourced online, study authors identified 98 unique websites offering any form of semaglutide, tirzepatide, or liraglutide between July and September 2024. Most of them — 79 out of 98 — sold compounded versions and all but two provided prescriptions for compounded GLP-1 RAs. Further analysis revealed that websites were not always forthcoming with pertinent information and at times were downright misleading. Nearly one-half failed to report adverse effects, warnings and precautions, and contraindications. More than 36% stated or suggested that compounded GLP-1 RAs were approved by FDA, and about 40% featured an efficacy claim not included in the FDA-approved label on branded versions. Some did not even disclose that the drugs were compounded. “The FDA could require websites to explicitly disclose and define compounding, including lack of FDA approval; institute unique naming conventions for compounded medications; and be given greater authority to act against misleading compounded medication advertising,” the investigators offer as regulatory strategies for meeting truthful advertising standards.

THREE PBM GETS SUED

FTC sues, chides CVS and Cigna as part of PBM probe

https://ncpa.org/newsroom/qam/2025/01/23/ftc-sues-chides-cvs-and-cigna-part-pbm-probe

Word is circulating that Lina Khan—who served as the chair of the Federal Trade Commission under former President Joe Biden—will soon resign from the commission, but her tenure at the agency comes to a close with yet another swipe at PBMs. The FTC has sued CVS Health and Cigna, which Khan said have each “produced only a fraction of the documents required” by the agency’s Section 6(b) investigation into the PBM industry and have “refused to provide basic information about their compliance efforts.” This noncompliance appears to be part of a broader pattern of disregard for commission orders, she said, reiterating that “FTC orders are not suggestions.” Khan also suggested the commission consider whether further recourse is warranted specifically for CVS’ counsel.

The FTC previously sued the big three PBMs and their affiliated group purchasing organizations for favoring high-priced drugs over cheaper alternatives to generate bigger rebates.

Khan’s term as chair expired in September, and Andrew Ferguson was officially designated as chair this week by President Donald Trump. Ferguson joined the FTC in the spring. He was one of four commissioners who voted in favor of issuing the agency’s first interim staff report on PBM practices’ negative impacts on consumers and patients. The commission voted 5-0 to allow staff to issue the second report this month, and in a concurrent statement about it, Ferguson said, “The commission still has more work to do on this Section 6(b) study. I remain committed to bringing it to a conclusion, culminating in a final report.”

https://ncpa.org/newsroom/qam/2025/01/23/speaking-lawsuits

Bil and Shanon Schmidtknecht have been passionately speaking out against PBMs and fighting for reforms since their 22-year-old son, Cole, died last January after he couldn’t afford his Advair prescription at a Walgreens pharmacy in Wisconsin because of an insurer/PBM’s formulary decision. Accusing OptumRx of negligence and violating several different Wisconsin statutes, the Schmidtknechts this week filed a federal lawsuit seeking punitive damages. “The conduct of both OptumRx and Walgreens was deplorable,” says a statement from the family’s attorney. “The evidence in this case will show that both OptumRx and Walgreens put profits first, and are directly responsible for Cole’s death.” Learn more about the lawsuit via WBAY and watch our digital advertisement that helps to amplify their story.

Civil Asset Forfeiture 68.8 billion confiscated most with no charges nor conviction

With this law, the actual who/what is guilty is what asset is confiscated. How does a house/boat/stack of money defend themself? With the majority of the currency forfeited is < $500, the cost of trying to retrieve the asset by proving it is not ill gotten gain, what is the cost of hiring an attorney to go to trial? Since many of the assets are confiscated by an attorney from the DOJ, prosecutor or district attorney, so when the “guilty party” goes to court, it is up against the attorney who first decided that the asset was ill gotten gain. Bureaucrats that seize and confiscate – especially currency – they are allowed to put it in their coffers to spend as they wish for some “toy” they want for their department.

what is the total dollars that bureaucrats- at all levels federal/state/county/city – have confiscated money from companies and individuals that were never convicted of any crime using our civil assets forfeiture law?

Since 2000, civil asset forfeiture has resulted in at least $68.8 billion being confiscated by federal, state, and local governments in the United States. This figure includes assets seized from individuals and companies without requiring a criminal conviction, but it is likely an undercount due to incomplete data from many states[4].

In 2014 alone, federal forfeitures amounted to over $5 billion, surpassing the $3.5 billion stolen by burglars that year[7]. In recent years, annual forfeitures have remained substantial. For example, in 2021, the U.S. Marshals Service handled over 17,000 assets through forfeiture[5], and California reported $33.8 million in state-level forfeitures plus $11.8 million in federal equitable sharing funds[2].

While exact totals across all levels of government are challenging to calculate due to inconsistent reporting and varying laws, civil forfeiture remains a significant source of revenue for law enforcement agencies nationwide[8].

Citations:
[1] https://www.justice.gov/afp/file/5-yr_forfeiture_trends.pdf/dl
[2] https://oag.ca.gov/system/files/media/2021-af.pdf
[3] https://www.leg.state.nv.us/Session/77th2013/Exhibits/Senate/JUD/SJUD305I.pdf
[4] https://ij.org/press-release/new-report-finds-civil-forfeiture-rakes-in-billions-each-year-does-not-fight-crime-2/
[5] https://www.usmarshals.gov/what-we-do/asset-forfeiture/fact-sheet
[6] https://www.govinfo.gov/content/pkg/CHRG-106shrg66959/html/CHRG-106shrg66959.htm
[7] https://en.wikipedia.org/wiki/Civil_forfeiture_in_the_United_States
[8] https://ij.org/report/policing-for-profit-3/pfp3content/forfeiture-is-lucrative-for-governments-nationwide/
[9] https://www.aclu-il.org/sites/default/files/field_documents/asset_forfeiture_in_illinois.pdf

A significant portion of civil asset forfeiture proceeds come from individuals who were never found guilty of any crime. While exact figures are difficult to determine due to inconsistent reporting across jurisdictions, several key statistics highlight this issue:

1. In South Carolina, 19% of people targeted for civil forfeiture over a three-year period were never arrested, and nearly 800 people were charged with a crime but not convicted[1].

2. In Philadelphia, only about 1 in 4 respondents in a study was found or pleaded guilty to wrongdoing, yet 69% saw their property forfeited permanently[4].

3. Nationwide, since 2000, states and the federal government have forfeited at least $68.8 billion through civil asset forfeiture[2]. While this total includes seizures from both convicted criminals and innocent individuals, a substantial portion likely comes from people never found guilty.

4. The median value of forfeitures is relatively low in many states. For instance, in Michigan, half of all civil forfeitures of currency were worth less than $423, and in Pennsylvania, the median value was $369[3]. These low values suggest that many seizures target ordinary citizens rather than major criminals.

5. In 2014, federal asset forfeiture accounted for over $5 billion, surpassing the $3.5 billion stolen by burglars that year[7]. This comparison illustrates the scale of civil forfeiture and suggests that a significant portion may come from non-criminal seizures.

While it’s impossible to provide an exact dollar amount, these statistics indicate that billions of dollars have likely been confiscated from individuals never found guilty of a crime through civil asset forfeiture.

Citations:
[1] https://eji.org/news/south-carolina-civil-forfeiture-disproportionately-targets-black-men/
[2] https://ij.org/press-release/new-report-finds-civil-forfeiture-rakes-in-billions-each-year-does-not-fight-crime-2/
[3] https://www.propublica.org/article/police-say-seizing-property-without-trial-helps-keep-crime-down-a-new-study-shows-theyre-wrong
[4] https://ij.org/report/frustrating-corrupt-unfair/
[5] https://standtogether.org/newsroom/constitutionally-limited-government/civil-asset-forfeiture-statistics-abuse-stand-together-trust
[6] https://www.templeton.org/news/how-policing-for-profit-disproportionately-affects-poor-and-minority-groups
[7] https://en.wikipedia.org/wiki/Civil_forfeiture_in_the_United_States
[8] https://walberg.house.gov/media/in-the-news/epoch-times-civil-forfeiture-how-government-makes-billions-taking-americans

]

The introduction to a NEW MEDICAL DISEASE associated with opioid uses

At the top of this article published in 2024 Physicians Postgraduate Press, Inc  and www.psychiatrist.com had this posted at the top of the article

Posting of this PDF is not permitted. | For reprints or permissions, contact
permissions@psychiatrist.com. | © 2024 Physicians Postgraduate Press, Inc.

So I copied ONE PARAGRAPH from the article that seems to plainly describes the target of this article and that is to convince the Psychiatrist’s profession to look at considering putting a DX of OUD ( Opioid Use Disorder) on any pt being prescribed a opioid to treat their chronic pain and they seem to try and create a new disorder POUD (Prescription Opioid Use Disorder). I wonder how long it will take for there to be a ICD-10 code for this “medical issue”

Apparently the medical term POUD was first published in this article in July 2024 Prescription Opioid Use Disorder Among Adults Reporting Prescription Opioid Use With or Without Misuse in the United States  https://pubmed.ncbi.nlm.nih.gov/39028542/

and by the title the article the authors of this article appear to create this medical disease was to be DXd to people taking opioids WITH OR WITHOUT MISUSING the OPIOID and in this article there are 34 references.  Maybe that is what it takes to try and introduce a NEW DISEASE STATE to be recognized?

I also included the Relevant Financial Relationships of the two authors from the article.

I asked www.perlexity.ai to summarize this article and here is its response:

This article, titled “The Opioid Industry’s Legacy: A Generation of Prescribed Suffering” by Andrew Kolodny and Robert M. Bohler, discusses the far-reaching consequences of the opioid industry’s campaign to increase opioid prescribing in the United States. The authors highlight several key points:

## Underestimation of Opioid Use Disorder (OUD)

The National Survey on Drug Use and Health (NSDUH), the primary tool for measuring OUD prevalence, had a significant flaw that led to a massive undercount of OUD cases[1]. This flaw was influenced by opioid industry messaging, which claimed that OUD was rare in patients taking opioids as prescribed.

## Revised NSDUH Findings

After correcting the methodology, the United States Department of Health and Human Services (HHS) now estimates that:

– 5 million Americans suffer from prescription opioid use disorder (POUD)[1][2]
– This number is more than triple the previous estimate from 2019
– 62% of people with POUD do not misuse their prescription opioids but take them as prescribed[1]

## Physiological Dependence and POUD

The article challenges industry-influenced educational messages that downplay the risk of POUD and the consequences of physiological dependence. Key points include:

– Physiological dependence can develop rapidly, even within the first few days of opioid use
– Opioid withdrawal symptoms can be severe and long-lasting
– The effects of physiological dependence and withdrawal help explain why millions of patients who take opioids as prescribed suffer from POUD

## Industry Influence on Perception

The authors describe how the opioid industry influenced various stakeholders to promote a false narrative about opioid use:

– Academics, professional societies, and journalists with financial ties to opioid manufacturers disseminated misleading information
– The distinction between physiological dependence and addiction was exaggerated
– State medical boards were influenced by industry-funded policies

## Conclusion

The article concludes that many patients prescribed opioids are not benefiting from long-term use but are actually suffering from POUD. The authors argue that these patients are victims of a campaign that promoted aggressive opioid use while minimizing the difficulties of discontinuation.

Citations:
[1] https://ppl-ai-file-upload.s3.amazonaws.com/web/direct-files/29836200/58a4853c-a264-44e1-bd4f-4235ce286a28/paste.txt
[2] https://ppl-ai-file-upload.s3.amazonaws.com/web/direct-files/29836200/2d619b85-40ba-4a8a-94bf-6458ea518a5a/paste-2.txt

www.psychiatrist.com/pdf/the-opioid-industry%ca%bcs-legacy-a-generation-of-prescribed-suffering-pdf/

Recently, in the pages of this journal, we learned that the National Survey on Drug Use and Health (NSDUH), the federal government’s primary tool for measuring the prevalence of OUD, was also influenced by opioid industry messaging. In the  article, “Prescription Opioid Use Disorder  Among Adults Reporting Prescription Opioid Use With or Without Misuse in the United States” by Han et al,1 the United States Department of Health and Human Services (HHS) acknowledged a serious and long-standing flaw in the NSDUH that led to a massive undercount of OUD. The survey had been systematically excluding patients prescribed opioids from receiving its OUD assessment. 

To Cite: Kolodny A, Bohler RM. The opioid industryʼs legacy: a generation of prescribed suffering. J Clin Psychiatry. 2025;86(1):24com15664.
Author Affiliations: Opioid Policy Research Collaborative, The Heller School for Social Policy and Management, Brandeis University, Waltham, Massachusetts (Kolodny); Jiann-Ping Hsu College of Public Health, Georgia Southern University, Statesboro, Georgia (Bohler). Corresponding Author: Andrew Kolodny, MD, 415 South St, MS 035, Waltham, MA 02453  (akolodny@brandeis.edu).

Relevant Financial Relationships: Dr Kolodny has received fees for serving as an expert witness in litigation against the opioid industry and is the president of the nonprofit organization Physicians for Responsible Opioid Prescribing. Dr Bohler has received fees for serving as a research consultant in litigation against the opioid industry.

 

 

 

Where the chronic pain community should focus its efforts going forward

I have very mixed emotions over this whole concept. I am a firm believer that any/all addictions have a significant underlying mental health issues. Recently U.S. Surgeon General Dr. Vivek Murthy declared that alcohol causes CANCER. Some self-declared opioid experts wants to declare that anyone being prescribed any controlled substance  should be diagnosed with a SUD. (Substance Abuse Disorder)

I often wonder how many politicians, bureaucrats from all levels of our bureaucracy (city, county, state, federal) should/could be diagnosed with SUD, yet they are being hypocrites on the real source of our fabricated opioid crisis and how they are technically are part of the problem?

Nicotine & Alcohol are both consider DRUGS and those two drugs contribute to some 550,000 deaths every year. Just how many of these bureaucrats should be Dx’d with SUD, but because of their positions/authority/power no one dare label them as such, but they have no problem with labeling just about anyone else taking a prescribed controlled med because they have a valid medical necessity for taking the medications.

On the web there is https://x.com@doge  @DOGE Dept of Government Efficiency. Should we all call the attention to @doge that “WE” spend an estimated 140 billion/yr in fighting the war on drugs and yet >100,000 of our citizens are dying (OD/poisoning) from Illegal substances and yet the DOJ/DEA is focused mostly on our healthcare system and healthcare providers within that system. I am a Pharmacist, but I cannot legally practice law, but “we” all see where attorneys in the DOJ/DEA and other sections of Federal & State agencies that are determining what medications pts should be prescribed. Basically practicing medicine, with obviously having no idea of what they are doing. Remember one of the basics of the practice of medicine is the starting, changing, stopping a pt’s therapy.  It doesn’t matter if you are talking about DEA limiting production quotas, the CDC developing opioid dosing guidelines using a the MME system that has no clinical studies behind their conclusions or the DOJ suing various parts of our healthcare system and “confiscating” profits from corporations selling legal products and services.

 

An NYC nonprofit has reversed 1,700 overdoses since 2021. Under Trump, it faces an uncertain future

https://www.statnews.com/2025/01/17/onpoint-overdose-prevention-uncertain-future-opposition-to-harm-reduction/

NEW YORK — Shawn has spent the better part of the last hour injecting fentanyl. But he is not in any danger: After a brief scare, when his heart rate dropped considerably, the pulse oximeter on his left index finger now says his vital signs are nearly back to normal. The staff at OnPoint NYC, the harm reduction nonprofit whose back room is designated for precisely this purpose, are no longer worried. Instead of administering medical care, they bring him a cup of coffee and a candy bar. 

It is late morning in East Harlem, a neighborhood long known not just for its cultural richness but also for the crime and drug use that often accompany poverty and neglect. Outside, it is 19 degrees. There is little telling what would befall Shawn, a 49-year-old originally from Columbus, Ohio, if he were to use outdoors, with his own syringe, by himself. But inside, he is warm. He is watched. He has a never-used sterile needle. And perhaps most importantly, he is not being judged. There is no police officer to harass or arrest him. There are no sidewalk passers-by to cast a disapproving stare. Here, Shawn, and other OnPoint participants, can use drugs as they please. 

Outside this room, the practice of supervised consumption remains highly controversial to much of the United States. But inside, such scenes play out hundreds of times per day, representing acts of compassion that, today, may have saved Shawn’s life — and that he says may soon allow him to leave fentanyl in the past. 

“We’re not trash,” said Shawn, a regular OnPoint participant who STAT is identifying only by his first name, in an earlier interview. “We just need a little human care and guidance.”

After Shawn uses the drugs he brought with him, OnPoint staff closely monitor his alertness and vital signs.

The care and guidance available to Shawn at OnPoint may soon be threatened. Harm reduction, the approach of providing judgment-free services meant to preserve drug users’ well-being without pressuring them to stop consuming, faces an uncertain political future in 2025. Even beyond typical conservative criticisms, local officials in deep-blue cities like Philadelphia and San Francisco have blamed harm reduction for the cities’ continued drug crises and, in some cases, moved to roll back some harm reduction policies. 

More recently, President Trump’s return to power has alarmed supporters of harm reduction and, particularly, supervised consumption. The first Trump administration took a hard line on the tactic, arguing the sites violated federal law and even suing to prevent a separate nonprofit from opening a similar site in Philadelphia. And though his pick for health secretary, Robert F. Kennedy Jr., is himself in long-term recovery from addiction to alcohol and heroin, he has advocated a “tough love” approach to other Americans struggling with substance use. 

As the first American facility to openly offer supervised consumption services, OnPoint stands on the frontlines of a long-running battle between those who favor a compassionate, harm reduction-oriented approach to the nation’s overdose epidemic and others who favor the harsher “War on Drugs” tactics that have historically dominated U.S. drug policy.

Though advocates contend that supervised consumption’s legality remains unsettled, there is little doubt that Trump has the standing to challenge OnPoint’s operations if he chooses to. But Sam Rivera, the organization’s executive director, has little time for hypotheticals. 

He is far more concerned with caring for the thousands of people who have passed through these doors in East Harlem and at a sister location in Washington Heights, nearly 4 miles to the north, since OnPoint began offering supervised consumption services in 2021. In that span, its records show, it has reversed over 1,700 overdoses without a single participant death. (OnPoint does not supply illegal drugs, or allow them to be sold or distributed, but allows participants to use any drugs they bring.)

Perhaps most remarkably, it has done so with the support of two New York mayors, including Eric Adams (D), a longtime police official, and a wink-and-nod tolerance from the Biden administration, which never formally countenanced supervised consumption but has made no attempt to stop it. 

“We had an opportunity to do the right thing, and we did it,” Rivera said during an interview in his office at OnPoint’s headquarters. “We’re operating an amazing service with an amazing staff providing services to beautiful human beings. And if no one does anything for me to respond to, we keep doing it. If something happens where we’re being challenged, I’m ready.” 

Entrance to OnPoint Harlem, a harm reduction facility, located on 126th Street in NYC.
The entrance to OnPoint’s headquarters on E. 126th St. in the East Harlem neighborhood of Manhattan.

Beyond its day-to-day function providing services ranging from HIV testing to laundry, OnPoint serves as a test case in U.S. drug policy. Rivera has embraced his de facto role as a nationwide spokesman for harm reduction and, on a more basic level, compassion. OnPoint, Rivera argues, has played a significant role upending common narratives about people who use drugs. 

“People have a perception of what we look like and what we do from the outside, and then they walk in and go: Oh, my God, I didn’t expect this,” Rivera said. “I think most times, people walk in just expecting to see people using drugs — like, you open the door, and it’s just people using drugs with no structure. It’s just this free-for-all. And then they come in and they see a loving environment where people are being cared for and people are being heard.” 

Still, some opponents cast supervised consumption sites as places of hopelessness: a white flag in the war on drugs, a decision to enable and even encourage drug use rather than oppose it. 

Rivera emphasizes that 100% of participants here have previously attempted some form of treatment or detox. Yet the harsh rules at methadone clinics, the discomfort that sometimes accompanies buprenorphine treatment, and the near-impossibility of quitting opioids without addiction medications often leads to setbacks. For many at OnPoint, the supervised consumption facility is simply a means of staying alive while plotting their next move. 

Sam Rivera, executive director of OnPoint NYC, chats with a staffer while seated in a booth typically used for supervised drug consumption.

Shawn is a prime example. His nearest-term goal is to gain control of his fentanyl use. But to do so, he’ll need methadone, a common medication used to treat opioid addiction. To enroll at a methadone clinic, he’ll need a photo ID. And to obtain an ID, he’ll need a birth certificate — which he currently doesn’t possess. So, as he navigates paperwork purgatory and continues to use fentanyl, he has turned to OnPoint as a safe haven. 

So, too, have many others who continue to use drugs like fentanyl, meth, and cocaine, inside and outside OnPoint’s walls. Much of the organization’s programming focuses on helping its participants survive the drugs they continue to use. Last month, one sign hanging just inside an entrance warned of a recent spike in fentanyl concentrations, from a high of 10% over the summer to 30% in the fall. 

Beyond offering supervised consumption indoors, the nonprofit’s staff spends countless hours working to prevent drug-related harms throughout much of Upper Manhattan. Staffers are deployed daily to help clear drug-related debris, like used syringes, from city streets. Others train staff and the public on how to administer naloxone and administer rescue breathing in the event of an overdose.