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.

Where is innocent until proven guilty and PROBABLE CAUSE

I am no attorney but I have always worked under the impression that law enforcement needs PROBABLE CAUSE to “go after” the alleged guilty party. In this article there is the words “alleges” and “likely” often used to justify the DOJ’s actions. Walgreens has some 8500 store, which would suggest that they employ over 20,000 pharmacists.  In this article it is stated that FOUR WALGREEN PHARMACISTS came forward as whistleblowers. In these sorts of lawsuits, if the DOJ prevail, the whistleblowers get to share with what the DOJ gets from Walgreens and CVS, and they can share 15%-25% of what the government gets.

With 20,000+ pharmacist working for Walgreens, who believes that there would be at least FOUR PHARMACISTS who are opiophobic – you know those who are “not comfortable” filling any opioid or other controlled substances?  With each of those whistleblowers focused on getting tens of millions if the DOJ wins this case.

Really no concern about all the pts that have a valid need for controlled meds, no regard for all the Walgreen stockholders that will lose money as the stock prices fall and the number of employees that will become unemployed as Walgreens closes the 1200+ stores that they are planning on closing. Below I asked perplexity a question and according to its answer, this action by our DOJ is more an EXTORTION than Walgreens violating our CSA, and a CASH GRAB by our DOJ- confiscating profits from a corporation for selling a legal product.

I asked www.perplexity.ai:  legally is probably cause and allegation the same?

Probable cause and allegation are not legally the same. Probable cause is a higher standard that requires more evidence than a mere allegation.

Probable cause is a legal standard that requires sufficient evidence to warrant a reasonable person to believe that a crime has been, is being, or will be committed[1][4]. It is based on the totality of circumstances and involves an assessment of probabilities[3]. Probable cause is necessary for police to obtain a warrant, make an arrest, or conduct a search[4][6].

An allegation, on the other hand, is simply an accusation or claim made without proof. While an allegation can trigger an investigation, it alone is typically not enough to establish probable cause[1]. Law enforcement must gather additional evidence to meet the probable cause threshold before formal charges can be brought[1][5].

The difference between the two concepts is significant in legal proceedings:

1. Investigations: An allegation may initiate an investigation, but probable cause is required to take more serious legal actions[1].

2. Arrests and searches: Probable cause is necessary for police to make an arrest or obtain a search warrant, whereas an allegation alone is insufficient[4][6].

3. Formal charges: Prosecutors typically require probable cause, not just an allegation, to bring formal charges against an individual[1].

4. Legal standard: Probable cause is a fluid concept that depends on the assessment of multiple factors, while an allegation is a straightforward claim[3][6].

In summary, while an allegation can be the starting point of a legal process, probable cause represents a higher evidentiary standard that is crucial for advancing criminal proceedings and protecting individuals’ rights against unreasonable searches and seizures[4][6].

Citations:
[1] https://www.pagepate.com/question/how-much-money-can-a-whistleblower-make/
[2] https://federal-lawyer.com/whistleblower-lawyers/average-settlement/
[3] https://www.phillipsandcohen.com/whistleblower-rewards/
[4] https://www.wblteam.com/average-whistleblower-settlement.html
[5] https://www.govexec.com/pay-benefits/2024/06/federal-whistleblowers-are-entitled-damages-missed-future-pay-court-rules/397638/
[6] https://www.whistleblower.gov/overview/applyforanaward
[7] https://www.laborlawpc.com/blog/demystifying-whistleblower-retaliation-settlements-a-look-at-averages-and-factors/
[8] https://pricebenowitz.com/whistleblower-lawyer/rewards/calculations/

DOJ hits Walgreens with lawsuit for filling ‘unlawful’ opioid prescriptions

https://thehill.com/policy/healthcare/5093368-doj-walgreens-opioid-prescriptions-lawsuit/

The Department of Justice (DOJ) hit drugstore chain Walgreens with a lawsuit this week for filling “unlawful” opioid prescriptions that had no “legitimate” medical purpose for over a decade. 

The lawsuit, which was filed in U.S. District Court for the Northern District of Illinois on Thursday, alleges that Walgreens’ pharmacists filled millions of prescriptions despite “red flags” indicating that they were likely to be unlawful and that it pressured its pharmacists to fill prescriptions while not taking the necessary time to “confirm their validity.”  

“Walgreens allegedly ignored substantial evidence from multiple sources that its stores were dispensing unlawful prescriptions, including from its own pharmacists and internal data,” the DOJ said in a Friday press release. 

“These practices allowed millions of opioid pills and other controlled substances to flow illegally out of Walgreens stores,” Principal Deputy Assistant Attorney General Brian M. Boynton added in a statement. 

The government alleged the company violated the Controlled Substances Act (CSA) by dispensing millions of unlawful prescriptions. The lawsuit alleges that Walgreens, which has over 8,000 pharmacies across the country, also breached the False Claims Act (FCA) by seeking reimbursement for many of the prescriptions from a variety of federal healthcare programs. 

“These laws are critically important in protecting our communities from the dangers of the opioid epidemic,” said acting U.S. Attorney Morris Pasqual for the Northern District of Illinois. “Our office will continue to work with our law enforcement partners to ensure that opioids are properly dispensed and that taxpayer funds are only spent on legitimate pharmacy claims.”

The DOJ said that four different whistleblowers, who used to work at Walgreens, filed whistleblower actions. Walgreens said it will stand behind its pharmacists and asked the court to shield the drugstore corporation from DOJ attempts to enforce “arbitrary rules.” 

“We are asking the court to clarify the responsibilities of pharmacies and pharmacists and to protect against the government’s attempt to enforce arbitrary ‘rules’ that do not appear in any law or regulation and never went through any official rulemaking process,” Wallgreens said on Friday. 

“We will not stand by and allow the government to put our pharmacists in a no-win situation, trying to comply with ‘rules’ that simply do not exist,” the company said, adding it looks forward to defending the “professionalism and integrity of our pharmacists.” 

The DOJ filed a similar lawsuit last month, that time against CVS Health, accusing the retail behemoth of aiding the opioid crisis by knowingly filling illegal prescriptions in an effort to “prize profits over patient safety.”

A brand new day in America

While I have not always agreed with our President Donald Trump. After college, I worked only 6-7 yrs as an employee.  I often “bucked the system” as an employee. Six years after college I decided to open my own community pharmacy, and before I retired years later, I had started a handful of businesses, not everyone was a success, but most were.

As being an entrepreneur myself, I have to respect President Trump for all his accomplishments both personally and for our country. Those people who have never own/ran a business. They have little/no idea of what is involved and the meaning contained by the saying “signing the front of a paycheck”.

Our country should be considered a business, and unfortunately most the people that we elected to run our country – at least during my lifetime – the majority seemed to be more interested in their own personal success and the POWER that they can wield.

I & “WE” can hope that President Trump can use his skills as a entrepreneur to lower our national debt, lower our tax rates and essentially put more MONEY in all our pockets.

Donald Trump comes to office as a “lame duck” because he can’t run for another term, so he doesn’t has to worry about getting re-elected and have to concede on his goals to cull political favor.

I heard on TV today that someone, some group is already filing lawsuits against a couple of President Trumps proposed programs. I am sure there will be more and others who are planting “landmines” that are designed to cause President Trump and our country to FAIL.

WHERE ARE THE LAW FIRMS: As the facts keeps mounting up about the consequences of under/untreated pain

We know that people who are having their pain management reduced or eliminated entirely, their QOL deteriorates dramatically, often the person becomes disabled, losing their job(s) or the business that they have owed and operated for years. Often the “healthy spouse” abandons/divorces the chronic pain spouse. Even if the “healthy spouse” stays, the family’s financial issues can be severely compromised, because of the cost of the medical care of the chronic pain spouse.

Within the article below it is stated what can contribute to dementia: “The Lancet Commission summarized the latest evidence, including the value of controlling vascular risk factors like blood pressure, obesity, diabetes, and smoking; optimizing exercise and sleep; and countering social isolation and depression. In later ages, addressing hearing and vision limitation is important, as is preventing falls and head injuries.”

How many of those risk factors can be attributed to a chronic pain pt that loses their pain management meds? Medical practitioners are suppose to be “healers”.

Maybe Pam Bondi or whoever is the new Federal Attorney General can be encouraged to look at the physical & mental damages the actions of the DEA/DOJ is doing to an estimated 100+ million chronic pain pts, including an estimated 15 million kids (<19 y/o) suffering from chronic pain.

Most of us know that in 1965 – before the CSA was signed into law – there is a law:

https://uscode.house.gov/view.xhtml?req=(title:42%20section:1395%20edition:prelim)

From Title 42-THE PUBLIC HEALTH AND WELFARE CHAPTER 7-SOCIAL SECURITY SUBCHAPTER XVIII-HEALTH INSURANCE FOR AGED AND DISABLED

§1395. Prohibition against any Federal interference

Nothing in this sub chapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

I asked perplexity.ai:  could under/untreated pain cause an increase in dementia?

Yes, under/untreated pain could potentially cause an increase in dementia risk and exacerbate symptoms in those already diagnosed with dementia. Several studies have found significant associations between chronic pain and cognitive decline:

1. Chronic pain lasting over three months raises the risk of cognitive decline and dementia[1]. In a 60-year-old person with one site of chronic pain, the hippocampus (crucial for learning and memory) aged by about a year compared to those without pain[1].

2. Untreated pain in dementia patients can lead to observable neuropsychiatric symptoms like depression, agitation, and restlessness, which were previously thought to be solely due to neurodegeneration[2].

3. A large cohort study found that chronic pain was associated with a higher risk of dementia, especially in the 50-64 age group[3]. The increased risk persisted even after 5 years of follow-up[3].

4. Chronic pain may contribute to dementia risk through several mechanisms:
– Disruption of attention and memory processes[3]
– Impairment of decision-making and processing speed[3]
– Increased production of endogenous cortisol, potentially leading to hippocampal degeneration[3]
– Chronic inflammation, which may affect brain connectivity and function[1]

5. Untreated pain in dementia patients can lead to reduced quality of life, poor sleep patterns, impaired social interactions, and aggressive behaviors[5]. These factors may further contribute to cognitive decline.

6. Research suggests that in individuals with chronic pain, cognitive decline is likely to progress more rapidly[8].

Given these findings, proper pain assessment and management are crucial, especially in older adults and those with dementia, to potentially reduce the risk of cognitive decline and improve quality of life.

Citations:
[1] https://edition.cnn.com/2023/02/20/health/dementia-chronic-pain-wellness/index.html
[2] https://pmc.ncbi.nlm.nih.gov/articles/PMC8543251/
[3] https://www.painphysicianjournal.com/current/pdf?article=NzMyOA%3D%3D&journal=138
[4] https://aaic.alz.org/releases_2023/opioids-increase-risk-death-older-adults-dementia.asp
[5] https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2020.592366/full
[6] https://www.jpain.org/article/S1526-5900(07)00601-3/fulltext
[7] https://pubmed.ncbi.nlm.nih.gov/34089652/
[8] https://www.verywellhealth.com/top-tips-on-causes-and-signs-of-un-treated-pain-in-dementia-3573193

Dementia Cases to Double in the U.S.

https://www.medpagetoday.com/neurology/dementia/113756

1 million adults projected to develop dementia each year by 2060

Key Takeaways

  • U.S. dementia cases were projected to reach 1 million annually by 2060, doubling from 514,000 cases in 2020.
  • Lifetime dementia risk was estimated at 42%, with incidence increasing after age 75.
  • Projected rates were highest in Black adults, women, and APOE4 carriers.

Dementia cases in the U.S. are expected to double in the next four decades, a new analysis suggested.

In a racially and geographically diverse sample, the lifetime risk of dementia was estimated at 42% (95% CI 41-43) with incidence increasing substantially after age 75, according to Josef Coresh, MD, PhD, of New York University Grossman School of Medicine in New York City, and co-authors.

Based on U.S. Census data, the number of adults who will develop dementia each year was projected to increase from about 514,000 in 2020 to 1 million in 2060, Coresh and colleagues reported in Nature Medicine

Projected rates were highest in Black adults, women, and APOE4 carriers, with lifetime risks ranging from 44% to 59% in these groups. Mortality was treated as a competing event.

“It’s important to note that the risk from ages 55 to 75 is 4%,” Coresh told MedPage Today. “It rises to 20% by age 85 and then 42% by age 95, so half the risk is after age 85.”

The lifetime risk figures are considerably higher than previous estimates. Data from the Framingham Heart Study data suggested, for example, that about 14% of men and 23% of women in the U.S. would develop dementia during their lives.

The new estimates came from a more diverse group of people followed from 1987 to 2020, using an extensive range of methods to ascertain dementia, Coresh pointed out. It relied on data from the Atherosclerosis Risk in Communities (ARIC cohort, which was more diverse geographically, racially, and socioeconomically than other studies, he added.

The analysis extends existing research by quantifying the growth of incident dementia, incorporating trends that likely will be driven by the Baby Boom generation reaching older ages, the researchers said. The findings highlight the importance of strategies to reduce dementia risk and address racial inequities in healthcare, they added.

“We now know that half of dementia risk is preventable,” Coresh said. “The Lancet Commission summarized the latest evidence, including the value of controlling vascular risk factors like blood pressure, obesity, diabetes, and smoking; optimizing exercise and sleep; and countering social isolation and depression. In later ages, addressing hearing and vision limitation is important, as is preventing falls and head injuries.”

In the U.S. and globally, there’s an urgent need to address the crisis of Alzheimer’s disease and dementia, noted Maria Carrillo, PhD, chief science officer and medical affairs lead for the Alzheimer’s Association in Chicago, which wasn’t involved with the study.

“In the coming years, more people will be affected,” Carrillo said. “This is especially true for high-risk groups who often have been underrepresented in research, including Black Americans, Hispanic Americans, and women.”

The ongoing POINTER trialis evaluating whether lifestyle interventions that simultaneously target several risk factors can protect cognitive function in people at increased risk for cognitive decline, she added.

Coresh and colleagues evaluated health records from 15,043 participants in the community-based, prospective ARIC cohort in North Carolina, Mississippi, Minnesota, and Maryland who were 55 and older. All were dementia-free at age 55.

The sample included 55.1% women and 26.9% Black participants. About a third (30.8%) of participants had at least one APOE4 allele.

Over a median follow-up of 23 years, there were 3,252 incident cases of dementia. Of the dementia cases, 49% were diagnosed through phone interviews, 27% through hospital and death record review, and 24% at study visits with cognitive testing.

Differences in risk across race emerged at about age 75, while sex differences emerged at about age 85. Lifetime risks were 41% in white versus 44% in Black participants, and 35% in men versus 48% in women, due perhaps to women’s higher life expectancy.

People with two APOE4 copies had a higher lifetime risk of dementia (59%) than those with one copy (48%) or no copies (39%), with differences starting at around age 70.

The analysis had several limitations, the researchers acknowledged. Some dementia cases may have been misclassified, and some cases might not have been captured. The study also was not externally validated.

“Future population-based studies with long follow-up and comprehensive dementia ascertainment are needed to validate our lifetime risk estimates,” they wrote.