The article below is just the first page of a 5-page article, and the hyperlink below will bring up the entire article
2011.12 InterRights Bulletin Article_only
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Journavx: not suitable for chronic pain or the most severe acute pain cases
Posted on May 28, 2025 by Pharmaciststeve
Overview of Vertex’s New Acute Pain Medication: Journavx (Suzetrigine)
Vertex Pharmaceuticals’ Journavx (suzetrigine) is a newly FDA-approved, first-in-class, non-opioid oral medication for moderate-to-severe acute pain, such as that experienced after surgery or injury1231014. It represents the first new class of acute pain therapy in over 20 years and has generated significant interest among clinicians and patients seeking alternatives to opioids123912.
Professional Reviews
Efficacy and Clinical Trial Results
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Journavx demonstrated statistically significant pain reduction compared to placebo in two pivotal phase 3 trials involving patients undergoing abdominoplasty and bunionectomy1101114.
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The drug did not outperform the opioid combination of hydrocodone and acetaminophen (Vicodin) but did provide effective pain relief without opioid risks61314.
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Median time to meaningful pain relief was 2 hours for abdominoplasty and 4 hours for bunionectomy, compared to 8 hours for placebo11.
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Clinical experts, including pain specialists, describe Journavx as “compelling” and a “potential game-changer,” especially for filling the treatment gap between NSAIDs/acetaminophen and opioids14712.
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The Institute for Clinical and Economic Review (ICER) found the evidence for net health benefit compared to non-systemic therapies to be split among reviewers, but acknowledged the drug’s potential to reduce opioid use disorder and its societal costs5.
Safety Profile
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Journavx was generally well tolerated in clinical trials, with fewer adverse events than placebo in some studies1314.
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Most common side effects included itching, muscle spasms, elevated creatine phosphokinase, and rash61011.
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Contraindicated with strong CYP3A inhibitors and grapefruit products due to drug interactions61011.
Limitations and Concerns
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Journavx is only approved for short-term (acute) pain, not chronic pain, although studies are ongoing for chronic indications3714.
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Its analgesic strength is described as “weak” compared to opioids, making it suitable primarily for moderate-to-severe acute pain but not for the most severe cases61314.
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Cost is a significant concern: $15.50 per pill or about $31 per day, much higher than generic opioids, which may limit insurance coverage and patient access248.
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Some experts remain cautious, noting that more long-term safety and efficacy data are needed, and that it is too early to definitively declare the drug non-addictive258.
Patient Feedback
Reported Experience
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In a phase 3 trial, over 83% of patients rated Journavx as “good,” “very good,” or “excellent” for pain relief after surgery or other acute pain events14.
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Patients appreciated the non-opioid option, especially those concerned about addiction or unable to tolerate opioids3614.
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Some patient organizations and advocates note that while the pain relief is meaningful, it may not be as strong as what some patients expect from opioids, and it is not suitable for chronic pain or the most severe acute pain cases67.
Side Effects
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Most patients tolerated the drug well, with mild side effects such as itching and muscle spasms being the most common61011.
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No reports of euphoria, dependence, or withdrawal have emerged in clinical trials, supporting its non-addictive profile so far23714.
Summary Table: Journavx (Suzetrigine) vs. Opioids for Acute Pain
| Feature | Journavx (Suzetrigine) | Opioids (e.g., Hydrocodone) |
|---|---|---|
| Mechanism | NaV1.8 sodium channel inhibitor | Mu-opioid receptor agonist |
| Addiction Risk | No evidence so far | High |
| Efficacy (vs. Placebo) | Superior | Superior |
| Efficacy (vs. Opioids) | Inferior or similar | Superior |
| Most Common Side Effects | Itching, muscle spasms, rash | Nausea, constipation, sedation |
| Cost (per day) | ~$31 | <$1 (generic) |
| Insurance Coverage | Uncertain, may be limited | Broad |
| Approved Use | Acute pain only | Acute and chronic pain |
Bottom Line
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Journavx (suzetrigine) is a promising, non-opioid option for moderate-to-severe acute pain, offering effective relief without the risk of addiction associated with opioids12314.
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It is not as potent as opioids and is not approved for chronic pain, but it fills a critical gap for patients who need more than NSAIDs/acetaminophen but want to avoid opioids461314.
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High cost and insurance barriers may limit widespread adoption, and long-term safety and real-world effectiveness remain under review2458.
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Both professionals and patients are cautiously optimistic, with many describing it as a significant advance in pain management, though not a “silver bullet” for all pain scenarios23712.
Citations:
- https://www.neurologylive.com/view/fda-approves-vertex-pharmaceuticals-suzetrigine-acute-pain-management
- https://www.biopharmadive.com/news/vertex-pain-non-opioid-drug-fda-approval-journavx/738721/
- https://www.nbcnews.com/health/health-news/fda-approves-new-type-nonopioid-painkiller-acute-pain-rcna189871
- https://www.biospace.com/drug-development/vertexs-journavx-changes-the-pain-treatment-landscape-but-opioids-here-to-stay
- https://icer.org/news-insights/press-releases/institute-for-clinical-and-economic-review-publishes-final-evidence-report-on-treatment-for-acute-pain/
- https://rsds.org/a-new-pain-killer-on-the-market-the-good-and-the-not-so-good-on-journavx/
- https://psyclarityhealth.com/hopeful-new-non-addictive-pain-relief-by-vertex/
- https://www.biopharmadive.com/news/pain-drug-vertex-opioid-price-insurance-journavx/738856/
- https://www.pharmexec.com/view/fda-approves-vertex-pharmaceuticals-first-class-non-opioid-journavx-moderate-severe-acute-pain
- https://www.fda.gov/news-events/press-announcements/fda-approves-novel-non-opioid-treatment-moderate-severe-acute-pain
- https://www.drugs.com/journavx.html
- https://cen.acs.org/pharmaceuticals/drug-development/FDA-approves-new-nonopioid-pain-medication-hailed-a-triumph/103/web/2025/01
- https://www.statnews.com/2025/01/30/vertex-pain-drug-journavx-wins-fda-approval-non-opioid/
- https://www.cnbc.com/2025/01/30/fda-approves-vertex-non-opioid-painkiller-drug.html
- https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class
- https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-advancements-suzetrigine-vx-548-acute-and
- https://www.definitivehc.com/resources/healthcare-insights/most-common-pain-medication
- https://www.thepharmaletter.com/icer-evidence-report-on-vertex-new-treatment-foraacute-pain
- https://www.vrtx.com/stories/state-pain-america/
- https://www.reddit.com/r/ChronicPain/comments/1japyo2/ive_got_journavx_suzetrigine_in_my_hand_filled/
- https://www.biopharmadive.com/news/vertex-pain-drug-data-lumbosacral-radiculopathy-lsr-stock/736055/
- https://www.statnews.com/2024/12/19/vertex-chronic-pain-sciatica-suzetrigine/
- https://www.thepharmaletter.com/vertex-phase-2-suzetrigine-study-disappoints
Answer from Perplexity: pplx.ai/share
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Our healthcare system – nothing more – nothing less than a FOR PROFIT SYSTEM
Posted on May 27, 2025 by Pharmaciststeve
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‘Outright murder’: UnitedHealth pressured nurses to DNR patients who didn’t want to die
Posted on May 23, 2025 by Pharmaciststeve
Does anyone other than me care that AARP endorses UnitedHealth as its primary company that offers various health insurance to its members?
Here is a video of Senator Eliz Warren at a Senate committee hearing last year, appearing to “rip” the President of UnitedHealth over their policies. https://www.pharmaciststeve.com/warren-blasts-united-health-ceo-for-monopolistic-practices-that-harm-patients/
Now, this article that is coming out is about a questionable policy that appears to “bribe” nursing homes to implement some policies that could allow UnitedHealth to increase its profits.
‘Outright murder’: UnitedHealth pressured nurses to DNR patients who didn’t want to die
It’s safe to say UnitedHealth isn’t the most beloved company out there. The for-profit insurance company has ruined (and ended!) countless lives, been embroiled in many controversial denials of care, has faced SEC investigation for fraud, fought legal action for overbilling Medicare, and routinely humiliates those who rely on it for medical treatment.
All of which meant that when Brian Thompson was executed on the streets of New York on Dec. 4, 2024, few shed a tear. Now the Guardian has released a shocking new investigation that indicates the company has expanded its scope from run-of-the-mill cruelty to outright murder.
The article details how UnitedHealth secretly paid nursing homes massive bonuses to “slash hospital transfers for ailing residents”, effectively denying them hospital treatment to save the insurer a few bucks. The reporting found that many of those denied transfer suffered long-term medical issues, with one patient receiving permanent brain damage.
But wait, it gets worse! One of the most horrifying tactics details is that United Health monitored the rates of “do not resuscitate” (DNR) and “do not intubate” (DNI) orders for nursing home patients. These permit doctors to allow someone to die if their heart stops beating, or if they are intubated in case of a medical emergency.
Nursing homes considered to have low numbers of DNR/DNI patients were then pressured to boost their numbers. The article reports that multiple current and former nurses claim that (as per the article): “UnitedHealth managers pressed nurse practitioners to persuade Medicare Advantage members to change their “code status” to DNR even when patients had clearly expressed a desire that all available treatments be used to keep them alive.”
Patients with DNR/DNI orders on their files are much more profitable for UnitedHealth as, once they’re dead, the company doesn’t need to continue paying for their medical care. As you might imagine, jaws are on the floor. Comments include “good lord”, “speechless”, and “savages”. And, as you can probably predict, many references to one Mr Luigi Mangione.
Perhaps we shouldn’t be surprised. Binding medical care to shareholder value is a recipe for a mile-high stack of corpses: the less treatment UnitedHealth has to pay for, the more profit they make. Shareholders demand annual growth, so what better way to achieve that than gradually tightening the metaphorical noose around their customers’ necks?
Even knowing all that, this is monstrous behavior from UnitedHealth. How do these people sleep at night?
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RFK Jr. Releases Much-Anticipated MAHA Report
Posted on May 22, 2025 by Pharmaciststeve
RFK Jr. Releases Much-Anticipated MAHA Report
https://www.medpagetoday.com/publichealthpolicy/washington-watch/115723
Report raises concerns about vaccines, foods, and prescription drugs
A government report released on Thursday covering wide swaths of American health and wellness reflects some of the most contentious views on vaccines, the nation’s food supply, pesticides, and prescription drugs held by HHS Secretary Robert F. Kennedy Jr.
The much-anticipated “Make America Healthy Again (MAHA)” report calls for increased scrutiny of the childhood vaccine schedule, a review of the pesticides sprayed on American crops, and a description of the nation’s children as overmedicated and undernourished.
While it does not have the force of a law or official policy, the 69-page report will be used over the next 100 days for the MAHA commission to fashion a plan that can be implemented during the remainder of President Donald Trump’s term, Kennedy said in a call with reporters. He refused to provide details about who authored the report.
“We will save lives by addressing this chronic disease epidemic head on, we’re going to save a lot more money in the long run — and even in the short run,” Kennedy said.
Increased scrutiny of childhood vaccines — credited with saving millions of people from deadly diseases — figures prominently in the report. It poses questions over the necessity of school mandates that require children to get vaccinated for admittance and suggestions that vaccines should undergo more clinical trials, including with placebos.
Kennedy, a long-time vaccine criticopens in a new tab or window who previously led a nonprofit that has made false claims about the shots, has continued to raise doubts about the safety of inoculations even as a measles outbreak has sickened more than 1,000 Americans. This week, Kennedy’s health department moved to limitopens in a new tab or window U.S. access to COVID-19 shots.
Other contentious parts of the report are creating factions within the Trump administration’s MAHA commission, even as it strained to appease opposing forces within the politically diverse coalition that Trump and Kennedyopens in a new tab or window have fostered.
The report makes dozens of references to dietary guidelines and standards in Europe but Environmental Protection Agency head Lee Zeldin promised it would not yield more rigorous regulations. Instead, he described a system where companies will be encouraged to comply when presented with new “gold-standard science.”
“This cannot happen through a European mandate system that stifles growth,” Zeldin said in a call with reporters.
Despite numerous studies and statements throughout the MAHA report that raise concerns about American food products, Trump Cabinet officials insisted that the nation’s food supply is safe.
The report mentions that glyphosate, a commonly used chemical sprayed on crops, may cause serious health problems, including cancer.
On Thursday, however, Agriculture Secretary Brooke Rollins insisted: “The food supply is 100% safe.”
Farmers and Republican lawmakers had houndedopens in a new tab or window the Trump administration leading up to the report’s release, worried it would criticize the chemicals they use. Kennedy’s MAHA supporters, too, have been concerned that he would bend to pressure on the issue.
Ultraprocessed foodsopens in a new tab or window — industrially made products high in refined grains, sugar, saturated fats, and additives like artificial dyes that now make up two-thirds of the diet for U.S. teens and children — are also hammered in the report. Such products have been linked to a host of poor health outcomes, though documentingopens in a new tab or window how they cause those problems has been notoriously difficult and time-consuming.
The MAHA commission report “is a pretty accurate depiction of the nutrition crisis facing our country,” said Dariush Mozaffarian, MD, DrPH, an expert in nutrition and policy at Tufts University.
The report focuses not only on ultraprocessed foods, but also how too few fruits, vegetables, legumes, nuts, seeds, and fish are present in U.S. diets, he noted. But the report leaves out excess salt, which causes harm, even in young children.
The MAHA report calls on the NIH to execute sweeping, nationwide studies of ultraprocessed foods, even as the White House has called for $18 billionopens in a new tab or window to be axed from the agency’s budget. An extra $500 million has been requested from Congress for Kennedy’s MAHA initiative.
The report raises concerns about other environmental and chemical research results, funded by corporations and industry, being skewed.
But the MAHA commission’s call for more neutral research comes as sweeping budget and staff cuts propelled by Trump’s Department of Government Efficiency have resulted in 20,000 jobs lostopens in a new tab or window at the nation’s health department and billions of dollars rescinded for research studies. The Trump administration also gutted the Environmental Public Health Tracking Programopens in a new tab or window in its cuts of health-tracking programs.
The report also raises concerns about lack of physical activity among children and their prescription drug use, including antibiotics and medications used to treat attention deficit disorders.
Trump is expected to speak about the report Thursday afternoon at the White House.
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Suicide and Attempted Suicide Trends in the Last 10 Years
Posted on May 21, 2025 by Pharmaciststeve
Interesting in how the number of suicides have increased and decreased over the last decade with references to 2016 – CDC first opioid dosing guidelines and 2020 the start of Covid-19 and 2022 the 2nd CDC opioid dosing guidelines.
Suicide and Attempted Suicide Trends in the Last 10 Years
Suicide Deaths:
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Over the past decade, suicide deaths in the United States have increased overall. After a period of modest decline from 2018 to 2020, suicide rates began to rise again, reaching record highs in 2022 and 20241356.
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The age-adjusted suicide rate rose from 12.3 per 100,000 in 2011 to 14.4 in 2022, representing a 16% increase over that period1. By 2024, the rate further increased to an estimated 14.7 per 100,000, with over 49,300 deaths, marking the highest levels since 19413.
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The total number of suicide deaths in 2022 was 49,369, the highest on record at that time1. This upward trend continued into 2023 and 20243.
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Suicide rates increased 37% between 2000 and 2018, dipped by 5% from 2018 to 2020, and then returned to peak levels by 2022256.
Demographic Patterns:
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Males account for about 80% of suicide deaths, with the highest rates among those aged 85 and older236.
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Non-Hispanic American Indian/Alaska Native people have the highest suicide rates among racial/ethnic groups3.
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Firearms are the most common method, involved in over half of all suicides, and firearm-related suicides have driven much of the recent increase13.
Youth and Young Adults:
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Suicide deaths among 10- to 24-year-olds increased by 62% from 2007 to 20218.
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The share of high school students who seriously considered suicide rose from 16% in 2011 to 22% in 2021. Suicide attempts in this group also increased from 8% to 10% over the same period7.
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Black youth and preteens have seen particularly sharp increases, with suicide rates among Black youth ages 10-17 rising by 144% between 2007 and 20208.
Attempted Suicides:
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Attempted suicides are far more common than completed suicides. It is estimated that there are about 25 suicide attempts for every suicide death4.
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In 2015, there were over 1.1 million suicide attempts in the U.S., roughly one attempt every 31 seconds4.
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Among high school students in 2021, 10% reported attempting suicide at least once in the past year, up from 8% in 20117.
Summary Table: Suicide Trends (2011–2024)
| Year | Suicide Rate (per 100,000) | Notable Trends |
|---|---|---|
| 2011 | 12.3 | Start of decade |
| 2018 | 14.2 | Peak before brief decline |
| 2020 | 13.5 | Lowest point in recent years |
| 2021 | 14.1 | Sharp increase resumes |
| 2022 | 14.4 | Record high number of deaths |
| 2023 (est) | 14.2 | Rates remain high |
| 2024 (est) | 14.7 | Highest since 1941, over 49,300 deaths |
Conclusion
Both suicide deaths and suicide attempts have increased over the last 10 years in the United States. After a brief decline around 2019–2020, rates have climbed to record highs, especially among youth and certain minority groups. The data highlight a persistent and growing mental health crisis, with firearms playing a significant role in the increase in suicide deaths1378.
Citations:
- https://www.kff.org/mental-health/issue-brief/a-look-at-the-latest-suicide-data-and-change-over-the-last-decade/
- https://www.lifespan.org/be-well/rise-suicide
- https://nchstats.com/us-suicide-rates/
- https://wmich.edu/suicideprevention/basics/facts
- https://www.cdc.gov/suicide/facts/data.html
- https://www.cdc.gov/nchs/products/databriefs/db464.htm
- https://www.pewtrusts.org/en/research-and-analysis/articles/2023/03/03/youth-suicide-risk-increased-over-past-decade
- https://medicine.yale.edu/news-article/youth-suicide-is-on-the-rise-yale-aims-to-save-lives/
- https://afsp.org/suicide-statistics/
- https://www.nimh.nih.gov/health/statistics/suicide
Answer from Perplexity: pplx.ai/share
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UPDATE ..Is this Walmart Pharmacist making up rules and telling pts it is THE LAW?
Posted on May 21, 2025 by Pharmaciststeve
UPDATE
Dear Steve;
Thank you so much for getting back to me. I had your email on the ready when I went to pick up my prescription-I called up to Walmart and was told it was filled and the pharmacist needed to speak to me when I picked it up. She apologized profusely for what the other pharmacist told me on the phone, and that the prescription was NOT on whatever list they have requiring notes every six months. I believe she said that pertained to schedule 2 controlled substances. So she said I should have no more problems after today.
I also learned from my primary doctor, when I called to tell her that I got my script, that pharmacies can now only fill scripts for a certain number of customers for lorazepam now. So what the tech at ShopRite told me was true. This is bizarre to me!
Again, thank you so much for the information. I always research things and was just lucky to have found your link.
Dear Steve; I came across an article you wrote when
I was Googling about an issue I am having with Walmart filling my Lorazepam prescription. My PCP has me call her office every month for a new script to be sent to Walmart for my 1mg
tablet that I take at night for anxiety. (I want to add here that I suffer from chronic pain due to serious issues with my cervical and lumbar spine, and was also diagnosed with Chiari Malformation at age 60) I had had no problems with my Lorazepam being filled for many years with Walmart until about 7 months ago. My script got sent in by my doctor as usual, and it was showing as delayed online when I checked. At that point I had already taken my last dose and called Walmart to ask why the delay. I was told by the pharmacist that they dropped the ball with me and I should have been providing them with a recent office visit note from my PCP. And that this is a DEA rule. Every six months a report is required from the doctor, and it isn’t the responsibility of the pharmacy to request that from the doctor to fill the script. The doctor should know this. So I called my PCP and apparently they sent the note because my script was filled. That note was sent in March 2025. When my doctor sent in the script for my May refill, again it comes up delayed. I called Walmart and was rudely told by the pharmacist that I have been on this medication for a long time, and a report or phone call from my doctor is required before they will fill it. So I contact my PCP again about this. At this point on May 20th, I have been two days without my medication. My PCP told me that the pharmacist is WRONG and the doctor sends a script in because the patient requires whatever the medication is. (I understand that Lorazepam is now considered a controlled substance. I also know that I do not EVER get a script from my doctor with refills on it for Lorazepam.) Are my doctor and myself wrong in thinking that my prescription should be filled without my personal medical reports be sent to them? That they should fill this script because it’s a new one every month? Your advice on this would be greatly appreciated. By the way, I also filed a complaint with Walmart through the corporate complaint line. I was told by the representative that the pharmacist is wrong. I will see today if the script is filled or not.
I do not know which state this pt lives but I have heard about any LAW that requires such procedures to get a C-4 refilled, so I ask www.perplexity.ai. It would appear that this particular Pharmacist is making up his own “rules” , and telling the pt that IT IS THE DEA LAW!
Is there a DEA rule that a pt must have an office visit every 6 months to get a controlled med filled, in particular Lorazepam?
There is no DEA rule that specifically requires a patient to have an in-person office visit every six months in order to receive a prescription for a controlled substance such as lorazepam (Ativan), which is a Schedule IV controlled substance37.
DEA Requirements for Controlled Substance Prescribing
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Initial In-Person Evaluation: Under the Ryan Haight Online Pharmacy Consumer Protection Act, a prescriber must conduct at least one in-person medical evaluation before prescribing any controlled substance, including lorazepam24. Exceptions exist for certain telemedicine scenarios, but these are specific and do not generally apply to routine outpatient care.
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Telemedicine Flexibilities: If a patient has already had an in-person visit with the provider, the DEA allows ongoing prescribing of controlled substances (including via telemedicine) without additional in-person visit requirements, unless otherwise specified by state law or clinical judgment14.
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Refill and Expiration Limits: For Schedule IV medications like lorazepam, prescriptions may not be filled or refilled more than six months after the date written, and may not be refilled more than five times7. This is a dispensing and refill limitation, not a mandate for a new office visit every six months.
State Law and Clinical Practice
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State Regulations: While the DEA does not mandate a six-month visit interval, individual states or insurance companies may have their own requirements for the frequency of patient evaluations for ongoing controlled substance prescriptions. These requirements can vary and may be stricter than federal rules.
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Clinical Standards: Many prescribers and clinics, as a matter of good clinical practice, require periodic follow-up visits (often every 3–6 months) to monitor for efficacy, side effects, and potential misuse, especially with benzodiazepines like lorazepam due to their risk profile3. However, this is a clinical or policy decision, not a DEA regulation.
Summary Table
| Requirement | DEA Federal Rule | Typical Clinical/State Practice |
|---|---|---|
| Initial in-person visit | Required | Required |
| Repeat visit every 6 months | Not required | May be required by state/clinic |
| Prescription expiration | 6 months | 6 months |
| Max refills (Schedule IV) | 5 | 5 |
Conclusion
The DEA does not require an office visit every six months to continue prescribing lorazepam or other Schedule IV controlled substances. The main federal requirements are an initial in-person evaluation and adherence to prescription expiration and refill limits. Additional visit frequency requirements, if any, are set by state law, insurance, or individual provider policy—not the DEA237.
Citations:
- https://www.dea.gov/press-releases/2025/01/16/dea-announces-three-new-telemedicine-rules-continue-open-access
- https://www.nixonpeabody.com/insights/alerts/2025/01/27/dea-announces-proposed-regulations-on-telemedicine-prescribing-of-controlled-substances
- https://www.singlecare.com/blog/is-lorazepam-a-controlled-substance/
- https://www.fenwick.com/insights/publications/understanding-the-deas-new-telemedicine-rules-faq-for-healthcare-providers-and-telehealth-companies
- https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-071)(EO-DEA226)_Practitioner’s_Manual_(final).pdf
- https://www.hklaw.com/en/insights/publications/2025/01/dea-extends-access-to-telehealth-treatment-with-new-rules
- https://www.drugs.com/medical-answers/rules-controlled-substance-prescription-refills-3572555/
- https://www.aha.org/news/headline/2025-01-15-hhs-dea-release-rules-related-telemedicine-prescribing-controlled-substances
- https://apps.deadiversion.usdoj.gov/guidance
- https://titangroupdea.com/dea-controlled-substance-regulations/
- https://www.mcdermottplus.com/insights/dea-extends-telemedicine-flexibilities-for-controlled-substance-prescribing-through-december-31-2025/
- https://telehealth.hhs.gov/providers/telehealth-policy/prescribing-controlled-substances-via-telehealth
- https://www.in.gov/dhs/files/DEA_Practicioner_Manual.pdf
- https://www.dea.gov/press-releases/2023/02/24/dea-announces-proposed-rules-permanent-telemedicine-flexibilities
- https://www.dea.gov/sites/default/files/2023-02/Controlled%20Substance%20Guidance.pdf
- https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-046R1)(EO-DEA154R1)_Pharmacist’s_Manual_DEA.pdf
Answer from Perplexity: pplx.ai/share
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Could the Microbiome Drive Chronic Pain?
Posted on May 21, 2025 by Pharmaciststeve
Could the Microbiome Drive Chronic Pain?
https://www.acsh.org/news/2025/05/15/could-microbiome-drive-chronic-pain-49468
The gut has been called our “second brain,” influencing everything from mood to metabolism. Now, scientists are asking whether it might also be shaping pain. In the case of a rare, debilitating condition marked by burning, hypersensitive limbs, researchers have identified an altered microbial signature that could help diagnose and explain the disease’s mysterious biology.
Generated by AI
One of the most poorly understood forms of chronic pain is complex regional pain syndrome (CRPS), characterized by an intense, disproportionate, burning pain, usually in a limb, often developing after an injury, surgery, or stroke. The autonomic nerves are involved as the skin frequently changes in temperature, color, sweating, and sensitivity.
It is a rare disease, and as I have described previously, suffers from a lack of diagnostic accuracy and effective treatment.
“CRPS remains challenging to treat, with patients often experiencing prolonged suffering before receiving appropriate care.”
– Amir Minerbi, MD, Director Institute for Pain Medicine, Rambam Health Campus Haifa, Israel
While it seems to be due, in part, to autonomic dysregulation, immune and inflammatory causes may play a role, and the diagnosis of CRPS rests on a patient’s signs and symptoms. A search for blood-borne biomarkers has found some candidate cytokines, but the cytokine’s assays sensitivity and specificity are too low to act as screening, let alone diagnostic tools. A new study in Anesthesiology looks at the gut microbiome as a potential biomarker.
Patients were recruited through clinics, personal outreach, and local media and screened for eligibility using an agreed-upon set of signs and symptoms, the Budapest criteria.
The criteria include:
- Continuing, disproportionate pain
- Presence of symptoms and signs of autonomic dysregulation. Specifically hypersensitivity, vasomotor changes (temperature or skin color changes), sudomotor changes (swelling or changes in sweat creation), changes in muscle strength or tone, and trophic changes in hair, nails, or skin.
Participants were scored using the CRPS Severity Score (CSS), which quantifies the presence of the Budapest criteria’s signs and symptoms on a yes-no basis. With a total score of 16, higher scores indicate greater CRPS severity. It is a standard measure used to track symptoms’ severity over time.
In addition to these more specialized tests, the participants underwent a series of surveys about the quality of physical and emotional life and, of course, our old friend, a food frequency questionnaire. A sample of 100 Israeli individuals, half diagnosed with CRPS and half age, gender, and ethnicity-matched pain-free controls, was used as a machine learning program training set. A similar group of 20 Canadian individuals served as the testing cohort providing a more generalized, international sample. All provided stool samples from which DNA was extracted characterizing their gut microbiome.
The cohorts had minor differences in smoking status, education, and employment. Perhaps the most significant unmatched variable was the use of pain meds by the CRPS patients. As might be anticipated, CRPS patients, compared to controls, had higher CRPS severity scores (mean of 12), greater pain, anxiety, and depression, and a poorer quality of sleep. More critically, the researchers did not detect any significant differences in diet between the two groups, although dietary differences, by their nature, are sometimes hard to quantify. [1]
Microbial Clues and Metabolic Echoes
Compared to pain-free individuals, CRPS patients harbored a markedly different community of gut bacteria. Particular species that play key roles in maintaining a healthy microbial ecosystem were notably diminished, while others emerged in higher numbers, painting a picture of a gut environment subtly but meaningfully different and, perhaps, “out of balance.”
In CRPS patients, key gut bacteria involved in succinate and propionic acid metabolism were significantly depleted, while species producing butyrate and lactic acid were elevated – a shift in fermentation pathways. These compositional changes echoed through the body as altered levels of short-chain fatty acids (SCFAs), chemical messengers with known anti-inflammatory and pain-modulating properties. In CRPS patients, levels of these metabolites were consistently lower in both stool and blood, suggesting a tangible loss of beneficial microbial function. Could the alterations in the microbiome alter the biochemical dialogue within the body, making CRPS not only a dysregulation of autonomic nerves but partially a disorder of microbial miscommunication?
Of greater interest, especially for those with CRPS, the altered microbiome was diagnostically informative. The training set identified a striking pattern of microbiome change that was accurate in identifying CRPS cases (90% sensitivity) and the matched controls (88% specificity). The findings against the Canadian test cohort were essentially the same.
As with all screening tests, the real value of sensitivity and specificity is determined by the prevalence of the disease in the screening population. Microbiome testing would make more sense in identifying those individuals with chronic pain in the more ambiguous range of the Budapest criteria. In the study, 50% of individuals with some, but not all, hallmarks of a formal diagnosis of CRPS were classified as CRPS patients based on their microbiome.
Most importantly, the dietary intake of patients and controls were comparable, suggesting that the changes identified were not due to diet. The caveat here is the pain medicines taken by the CRPS patients are an unwitting confounder, as medications can also alter our microbiome.
As with any good study, it raises more questions than it answers. The causal role of the gut in chronic pain disorders is “unfolding.” It is certainly unclear whether these changes are a predisposing factor, a secondary result of CRPS, or an artifact of pain management. As my colleague Dr. Bloom points out, acetaminophen is often a component of opioid medications and is known to alter the gut microbiome.
This study adds an intriguing layer to our thinking about CRPS: gut microbes may play a role in modulating symptoms and defining the disease. A distinct microbial signature, mirrored in reduced anti-inflammatory metabolites, opens the diagnostic door to reducing years of uncertainty. While what we see might be a cause, consequence, or collateral damage, it seems the gut has more say, and we’re just beginning to listen.
[1] CRPS patients in the Canadian test cohort consumed more eggs and fewer vegetables than their Israeli counterparts – you may temper your conclusions accordingly.
Source: Altered gut microbiome composition and function in individuals with complex regional pain syndrome Anesthesiology DOI: 10.1097/ALN.0000000000005435
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when you think you are a hammer, everything starts looking like a nail
Posted on May 20, 2025 by Pharmaciststeve
When I started reading this article, the first thing that came to mind was an old saying,” when you think you are a hammer, everything starts looking like a nail”. This reporter is interviewing two people who deal with addicts daily. When you interview people whose job it is to deal with or help addicts, and when you ask them to discuss people with addiction, you are going to get all the stats about addiction. Back before all the opioid OD/poisoning numbers climbed, addiction rehab typically had more alcoholics than people dealing with OUD. Today, it depends on the area as whether alcoholics or people dealing with OUD are the larger numbers of people rehab centers are dealing with. Also, today the number of people dying from opioids is at are near the 100,000 that die from alcohol use/abuse.
Managing opioid addiction
https://www.standardspeaker.com/2025/05/09/managing-opioid-addiction/
If a person has major surgery chances are they were prescribed opioids.
Hydrocodone, oxycodone, methadone and many others are all different types of opioids typically prescribed by doctors to treat severe or consistent pain. An opioid is a substance derived from a poppy plant and can be synthetic or semi-synthetic, meaning certain ingredients can be chemically-made in a lab.
Police say painkillers brought 39-year-old Jessica Lockwood and Terence Ray together. Lockwood had been suffering from chronic pain from neck surgeries and had been purchasing the painkillers from Ray, police said. Lockwood’s burning body was discovered April 27 along Club 40 Road in Hazleton and Ray faces homicide charges.
Opiates, however, differ from opioids in that they do not consist of synthetic ingredients, although both can be just as addictive.
Addiction to opioids typically stems from a legitimate prescription from a doctor to help with pain due to surgery, accident or chronic condition.
“As the person continues to take the substance their tolerance to the substance increases, requiring the person to need more of the pain pills to get the same desired effect,” said Eileen Panzarella, Prevention Director at Pathway to Recovery in Hazleton. “This often leads to misuse of prescription medications as the person begins to use more than prescribed. Due to regulations on the amount of prescription pain medications a doctor can now prescribe a person may try to purchase pills from another source.”
According to The National Center for Drug Abuse Statistics, 59.5% of individuals who are prescribed pain medications are currently abusing them. Additionally, 3.4% of Americans aged 12 and older misuse opioids at least once over a 12-month period. Hydrocodone is the most popular opioid with 5.1 million misusers.
“Some warning signs that we see in people who become addicted include lying about their use, trying to hide their use, taking their substance despite having negative consequences in their life, taking more of the medication than what is prescribed or becoming anxious about running out of their medication,” said Kristie Scheib, LPC, Clinical Director at Pathways to Recovery. “They may be asking to borrow money for reasons not related to buying pills.”
People may not think of an opioid addiction as having many physical clues but plenty do exist and can be spotted. Some physical signs would include a change in sleeping habits, drowsiness, a change in hygiene habits, gastrointestinal issues, irritability, isolation from friends and family, and not maintaining social or work obligations.
Panzarella calls addiction a “family disease” because it affects every member of a family differently and how you want to get involved is up to you.
“You can offer support to someone who is addicted and let them know that you are ready to help them when they want help, but ultimately it will be their decision when and how they get help,” she added.
The opioid addiction recovery process is different for every individual.
A person seeking detox can generally stay in a facility for up to a week. They could then be recommended to an inpatient facility where a typical stay can range from 30-90 days whereas outpatient therapy is typically six months or more.
Some of the best ways for people to seek help for an opioid addiction would be to contact your local county drug alcohol office or a local substance abuse counseling facility, or search online for rehab facilities that can help.
“It is important to note that recovery does not end when treatment is over,” Scheib said. “Recovery is a life-long journey and something that an individual will need to be aware of for the rest of their life. Recovery is a change in lifestyle and a person must keep up with that new lifestyle in order to avoid slipping back into active addiction.”
They stress how important stopping the stigma of substance abuse is. Noting that addiction is a brain disease and needing everyone to look at it just like they would any other disease.
“Many people will not seek treatment because they think it is a weakness to ask for help or that others will look down on them. We know treatment can and does work.”
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