October – Nat Breast Cancer Month & Down Syndrome

Posted on October 1, 2025 by Pharmaciststeve

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Fentanyl overdoses among seniors surge 9,000% — A hidden crisis few saw coming

Posted on October 15, 2025 by Pharmaciststeve

A deadly new wave of fentanyl-stimulant overdoses is claiming the lives of older adults at unprecedented rates.

https://www.sciencedaily.com/releases/2025/10/251012054606.htm

Summary:Overdose deaths from fentanyl mixed with stimulants have skyrocketed among seniors, increasing 9,000% in just eight years. Once thought to affect mainly the young, the opioid epidemic’s fourth wave now engulfs older adults too. Cocaine and methamphetamine are the leading culprits, and experts warn that multi-drug use makes these overdoses especially lethal. Doctors are urged to educate patients and caregivers on prevention and safer pain management.

Fatal overdoses among adults 65 and older involving fentanyl mixed with stimulants such as cocaine and methamphetamines have risen dramatically, climbing 9,000% in the past eight years. The rate now mirrors that seen in younger adults, according to findings presented at the ANESTHESIOLOGY® 2025 annual meeting.

This research is one of the first to use Centers for Disease Control and Prevention (CDC) data to reveal that older adults — often left out of overdose analyses — are increasingly part of the national surge in fentanyl-stimulant deaths. People in this age group face higher risks of overdose because many manage chronic illnesses, take multiple medications, and metabolize drugs more slowly as they age.

Experts describe the opioid epidemic as unfolding in four distinct “waves,” each tied to a different drug driving fatal overdoses: prescription opioids in the 1990s, heroin beginning around 2010, fentanyl taking hold in 2013, and a combination of fentanyl and stimulants emerging in 2015.

“A common misconception is that opioid overdoses primarily affect younger people,” said Gab Pasia, M.A., lead author of the study and a medical student at the University of Nevada, Reno School of Medicine. “Our analysis shows that older adults are also impacted by fentanyl-related deaths and that stimulant involvement has become much more common in this group. This suggests older adults are affected by the current fourth wave of the opioid crisis, following similar patterns seen in younger populations.”

To conduct the study, researchers examined 404,964 death certificates listing fentanyl as a cause of death from 1999 to 2023, using data from the CDC Wide-ranging Online Data for Epidemiologic Research (WONDER) system. Of those deaths, 17,040 involved adults 65 and older, while 387,924 were among adults aged 25 to 64.

Between 2015 and 2023, fentanyl-related deaths rose from 264 to 4,144 among older adults (a 1,470% increase) and from 8,513 to 64,694 among younger adults (a 660% increase). Within the older population, deaths involving both fentanyl and stimulants grew from 8.7% (23 of 264 fentanyl deaths) in 2015 to 49.9% (2,070 of 4,144) in 2023 — a staggering 9,000% rise. In comparison, among younger adults, fentanyl-stimulant deaths rose from 21.3% (1,812 of 8,513) to 59.3% (38,333 of 64,694) over the same period, a 2,115% increase.

Researchers chose to highlight 2015 and 2023 in their analysis because 2015 marked the beginning of the epidemic’s fourth wave, when fentanyl-stimulant deaths among older adults were at their lowest, and 2023 represented the most recent year of CDC data available.

The researchers noted that the rise in fentanyl deaths involving stimulants in older adults began to sharply rise in 2020, while deaths linked to other substances stayed the same or declined. Cocaine and methamphetamines were the most common stimulants paired with fentanyl among the older adults studied, surpassing alcohol, heroin, and benzodiazepines such as Xanax and Valium.

“National data have shown rising fentanyl-stimulant use among all adults,” said Mr. Pasia. “Because our analysis was a national, cross-sectional study, we were only able to describe patterns over time — not determine the underlying reasons why they are occurring. However, the findings underscore that fentanyl overdoses in older adults are often multi-substance deaths — not due to fentanyl alone — and the importance of sharing drug misuse prevention strategies to older patients.”

The authors noted anesthesiologists and other pain medicine specialists should:

  • Recognize that polysubstance use can occur in all age groups, not only in young adults.
  • Be cautious when prescribing opioids to adults 65 or older by carefully assessing medication history, closely monitoring patients prescribed opioids who may have a history of stimulant use for potential side effects, and considering non-opioid options when possible.
  • Use harm-reduction approaches such as involving caregivers in naloxone education, simplifying medication routines, using clear labeling and safe storage instructions and making sure instructions are easy to understand for those with memory or vision challenges.
  • Screen older patients for a broad range of substance exposures, beyond prescribed opioids, to better anticipate complications and adjust perioperative planning.

“Older adults who are prescribed opioids, or their caregivers, should ask their clinicians about overdose prevention strategies, such as having naloxone available and knowing the signs of an overdose,” said Richard Wang, M.D., an anesthesiology resident at Rush University Medical Center, Chicago and co-author of the study. “With these trends in mind, it is more important than ever to minimize opioid use in this vulnerable group and use other pain control methods when appropriate. Proper patient education and regularly reviewing medication lists could help to flatten this terrible trend.”

 

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Study Dings Medicare Advantage for Cancer Surgery Quality

Posted on October 15, 2025 by Pharmaciststeve

MA plan design may steer patients to specific centers, researchers suggest

https://www.medpagetoday.com/publichealthpolicy/medicare/117949

Key Takeaways

  • Enrollment in Medicare Advantage among those undergoing cancer surgeries increased from 32% in 2016 to 46% in 2022.
  • Medicare Advantage enrollees were less likely to undergo cancer surgery at high-quality hospitals versus traditional Medicare beneficiaries.
  • These findings suggest the Medicare Advantage plan design may steer patients to specific centers, potentially limiting choice.

Patients enrolled in Medicare Advantage (MA) plans were less likely to receive cancer surgery at high-quality hospitals compared with traditional Medicare enrollees, a national retrospective cohort study suggested.

Among over 500,000 older adults, higher proportions enrolled in traditional Medicare underwent cancer surgeries at high-quality hospitals compared with those in MA plans:

  • Esophagectomy: 21.7% vs 17.3%
  • Pancreatectomy: 22.6% vs 16.2%
  • Hepatectomy: 22.1% vs 17.5%
  • Gastrectomy: 23.4% vs 15.9%
  • Cystectomy: 21.9% vs 17.1%
  • Colectomy: 20.5% vs 19.5%
  • Nephrectomy: 21.1% vs 18.4%
  • Prostatectomy: 21.7% vs 17.7%

Moreover, MA beneficiaries were less likely than traditional Medicare beneficiaries to bypass a low-quality hospital in order to reach a high-quality center, reported Avinash Maganty, MD, MS, of Massachusetts General Hospital in Boston, and colleagues in JAMA Surgery

.

“This suggests that MA plan design may steer patients to specific centers and thereby potentially limit choice,” they wrote, which raises concerns “about the adequacy of cancer care delivery under privatized Medicare.”

Although there are “strong incentives” for MA plans to constrain utilization and to contain costs by avoiding contracts with high-quality centers that demand higher reimbursements, there are also incentives to ensure quality care, Maganty and team noted.

“However, the indicators they use to assess hospital quality may emphasize conditions more prevalent among their enrollees, rather than those specific to complex cancer care,” they added. “Notably, in our analysis, we found no association between MA plan star ratings, which are intended to reflect overall quality of a given contract, and the likelihood of receiving surgery at a high-quality hospital.”

In an accompanying

commentary, J. Joshua Smith, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and colleagues observed that while this study focused on procedure-specific mortality as a metric for the quality of cancer care, a broader definition of high-quality oncologic surgical care could include operative and pathologic standards, complication and readmission rates, patient experience ratings, and survival.

They suggested that a definition of cancer care quality should “extend beyond surgery, encompassing multiple oncologic disciplines, from diagnosis to palliative and end-of-life care.”

“Education about comprehensive cancer care quality would allow more informed insurance choices,” they concluded. “As healthcare policymakers develop a framework to improve care access, the surgical community must deliver the highest-quality surgical care regardless of the healthcare setting.”

For this study, Maganty and colleagues used Medicare Provider Analysis and Review data from January 2016 through November 2022. They included 567,770 Medicare beneficiaries who underwent elective surgery for esophageal, pancreatic, liver, gastric, bladder, colon, kidney, or prostate cancer at hospitals across the U.S. During the study period, enrollment in MA among those undergoing cancer surgeries increased from 32% to 46%.

Of the 351,447 enrolled in traditional Medicare, mean age was 72.5, 65.8% were men, 85.5% were white, and 9.1% were Black. Of the 216,323 enrolled in MA, mean age was 72.7, 64% were men, 78.8% were white, and 13.4% were Black.

Hospital quality was defined by procedure-specific mortality, risk-adjusted for patient characteristics and reliability-adjusted for differences in case volume using mixed-effects logistic regression models.

Compared with traditional Medicare beneficiaries, MA beneficiaries were more likely to have three or more comorbid conditions (47% vs 45%), more likely to reside in socially vulnerable areas (28.8% vs 24.6%), and less likely to undergo surgery at a teaching hospital (31% vs 36%).

MA beneficiaries traveled shorter distances to a treatment hospital for all procedures compared with traditional Medicare enrollees (mean 36 miles vs 60 miles). They lived closer to a high-quality hospital, but were less likely to bypass a lower-quality hospital to receive surgery at a high-quality hospital.

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MAINE RESIDENTS: You are living in a proper pain management DESERT

Posted on October 15, 2025 by Pharmaciststeve

Greetings pain Warriors 

Janet Mills has not been listening to our attempts to resolve Maine’s hostile environment toward legacy pain patients led by the New England drug task force, Noah Nessin, and Janet Mills 
POSTED ON FB GROUPS + YOUR/MY FEEDS .. 10/15

ASAP: Mark – you know about Governor Mills’ abdication of duty better than any physician!

You sent this to me to help publicize. “Janet Mills has not been listening to our attempts to resolve Maine’s hostile environment toward legacy pain patients led by the New England drug task force, Noah Nessin.”

You and I are asking all in our community … ALL .. to please choose one way or more to ensure that Mills does not replace Senator Susan Collins.

a/ send the above quote to all Maine media:
… print – broadcast – radio, etc.

b/ CALL – NOT email the governor’s office and read the quote.

c/ mail USPS: the above quote + some brief report on what you are suffering with/from – – NAMELY, THAT MAINE IS ONE OF THE WORST STATES IN THE U.S. FOR MEDICAL TREATMENT!

d/ if you get a fundraising communication from Mills – respond with quoting from Dr Mark above.

e/ if you are in Maine – have flyers with Dr Mark’s quote + mine in CAPS above – and post everywhere – on bulletin boards, etc.

ALL in our community weighing in in these user-friendly ways
CAN STOP MILLS!!!

WHY DO THIS IF YOU LIVE ELSEWHERE?
Because it will raise consciousness across America and impact your state and those officials!!

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Want to Call CDC to Report a Possible Disease Outbreak? Fuhgeddaboutit

Posted on October 15, 2025 by Pharmaciststeve

It’s likely no one will answer the phone, a former CDC employee says

https://www.medpagetoday.com/publichealthpolicy/washington-watch/117943

A photo of the entrance to CDC headquarters in Atlanta, Georgia.

Thinking of calling CDC to report a potential disease outbreak? Don’t bother; no one will answer, a former CDC employee said Tuesday.

“If it’s an infection that is being seen in the hospital in four different patients, and the infection control nurse calls [the CDC] … You are working with the physicians, the nurses, the schools, the restaurants, to try and sort through, ‘What is going on and what can we do?'” said Karen Remley, MD, MPH, former director of the CDC’s National Center on Birth Defects and Developmental Disabilities. “Sometimes that help might be, ‘We’re going to send some people to you; we’re going to give you more boots on the ground to help you do this.’ Sometimes that might be talking to somebody who’s one of the only world experts on a specific type of infection or a specific type of exposure. But [now] there’s nobody to answer the phone.”

“Being prepared and able to respond to public health emergencies is a core function of CDC,” said John Brooks, MD, former chief medical officer of the CDC’s Division of HIV Prevention, who retired from the CDC in September 2024. “Eight out of every 10 taxpayer dollars that CDC receives from Congress goes directly to support state and local staff and programs to help keep your community safe. Much of the remaining money is used to maintain and grow CDC’s public health expertise and its laboratory capacity that support these funded activities.”

“Today, many experts, including myself, are concerned that we are no longer well prepared for the next big outbreak or disaster because of the Trump administration’s continued erosion of our nation’s ability to respond to public health emergencies,” he added.

The cuts won’t just affect immediate operations like outbreak response — they will also affect longer-range projects, such as the annual National Health and Nutrition Examination Survey (NHANES) that the CDC conducts, Brooks said.

“Many of these very large, annualized … regular surveillance projects take a lot of planning. As they’re collecting data one year, the planning for the next year is well underway — how they’re going to do the randomization, how they’re going to find people, how they’re going to bring the data together and then analyze [it] — all of that is being planned, sometimes years in advance,” he explained. “With these regular surveys that have been collected on behalf of the public for many years, any interruption is unwelcome, because you lose that visibility on what’s happening.”

Remley and Brooks spoke Tuesday at a press conference organized by the National Public Health Coalition following a weekend in which approximately 1,300 HHS employees were fired

; about 700 of those had their termination notices rescinded less than 24 hours later. The Trump administration said those whose terminations were rescinded had been terminated due to a coding error

Reporters at Tuesday morning’s press conference also heard from Aryn Melton Backus, MPH, an employee at the CDC’s Office on Smoking and Health, who has received three different termination notices in the last few months.

“My first termination came during the wave of probationary employee firings,” she said. “On February 14, I was told that I was being terminated for poor performance during my trial period, despite having been on my team for almost 2.5 years and having been recently converted from a contractor to a federal employee. A judge has since ruled that these terminations were illegal.”

“My second termination came on April 1 when my office was eliminated during the agency-wide reduction in force [RIF],” she continued. “At first, I had no way to know if I had received a second termination notice, because my access to the CDC network had been cut off … I was finally able to regain access to my work email, and there was a reduction-in-force notice sent to my work email on April 1.”

“Despite the two termination letters, I’ve remained on administrative leave since February of this year due to a court case challenging the legality of the [first] reduction in force,” Backus said. “When word started spreading about the new reduction force, on October 10, I figured I was safe; a lawsuit [involving] my office prevents us from being further reorganized or fully separated. But then late Friday evening, I started hearing our team had received another reduction in force — a third for me. Luckily, that notice was rescinded less than 24 hours later, but I still remain on administrative leave, unable to do my job. My situation just highlights the chaos and confusion that federal employees have experienced over the past year.”

The American Federation of Government Employees (AFGE), which represents some of the fired workers, is fighting back. “[We are] demanding that all [RIF] notices be rescinded immediately,” AFGE Local 2883 President Yolanda Jacobs said at a separate press conference on Tuesday afternoon. “These illegal firings of our union members during a federal government shutdown [are] a callous attack on hardworking Americans and puts the livelihoods, health, and safety of our members and communities at great risk.”

Jacobs said she didn’t believe the now-rescinded RIFs happened because of an error. “I believe it was intentional,” she noted. “The administration did a whole lead-up campaign before they actually sent the notices out, to the point of even having the [Office of Management and Budget] director go on to X and say that the RIFs have begun. So, to me, it was not an error, those areas where they did reverse.” Instead, she added, the reversals happened because there was a lot of pushback on some of the firings.

One employee who received an RIF notice who was given anonymity in order to speak freely said she asked whether she could take another job while on administrative leave and was told she needed approval from the ethics office to be sure there wasn’t a conflict of interest. When the employee asked who she needed to contact in the ethics office, they said, “Well, you can’t, because they all got RIF letters too.”

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When the MEDIA puts a solution to the opioid crisis ON OUR TV

Posted on October 13, 2025 by Pharmaciststeve

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FYI

Posted on October 12, 2025 by Pharmaciststeve

My time that I am capable of dealing with my blog and pt’s issues may get restricted going forward. We were just told that the independent pharmacy that we have been patronizing for abt 10 yrs is not going to be in the Humana  Part D next year!  This guy owns the only two independents in our county. Open enrollment starts in a couple of days for Medicare.

Our PCP told us the first of this year, that he is retiring at the end of 2026. However, he has had a hip joint replacement.. which apparently got infected and the hip joint is DEFECTIVE and he is to put no weight on the defect hip joint for at least 12 weeks.

We have also been told that the practice that our PCP is in – it has 10-12 practitioners – is developing a consensus for the practice in how they are going to treat pain. In the real world if a number of business people agreed to do something the same way it would be referred to as a COLLUSION – NOT A CONSENSUS.

I talked to the office manager last week and I asked for a copy of this “consensus” and she said that they had not put it to writing… I suggested that might be a very good thing for them to do.

Going forward, I am going to focus my time on adding to the “ACTION” tab and putting pt education information there. 

I am not going to “share” on all the FB pages like a normally do with additions to the “ACTION” page.  Below is where you can put your email into a place on the left column on the first page of my blog and Word Press will send you a email that I had made a new entry and/or look for the last 4-5 new posts that are listed in the same column

Below is a picture of the desk in the room that I call “my office”, this is where all “the magic happens :-)”. We knew that we were most likely going to have to change practitioners at the end of 2026 – if we can find one, but maybe having to change pharmacies as well in a couple of months, and now not knowing if our PCP will be coming back to the practice.

I may end up spending a lot of time trying to ADVOCATE for Barb and myself. If my blog ends up going sort of quiet, everyone will understand why!


 

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Narxcare – what it IS and what it is NOT

Posted on October 12, 2025 by Pharmaciststeve

These are several audio presentations about Narxcare

 

 

 

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Hospitals Called Out for Unnecessary Back Surgeries on Seniors

Posted on October 9, 2025 by Pharmaciststeve

Analysis turned up 200,000 unneeded procedures that cost Medicare $2 billion over 3 years

https://www.medpagetoday.com/surgery/orthopedics/117856

The Lown Institute called out dozens of hospitals for performing unnecessary surgeries on Medicare beneficiaries with low back pain, putting patients at risk of serious complications with no evidence of clinical benefit.

Its analysis focused on high-volume hospitals that performed at least 500 spinal fusion/laminectomy or vertebroplasty procedures over a 3-year period — finding more than 200,000 unnecessary procedures amounting to about $1.9 billion in wasted Medicare spending during that time.

“We’re not doing this just to draw attention to the fact that there is unnecessary surgery,” Lown president Vikas Saini, MD, told MedPage Today. “We’re doing it to track how much, so people who want to do something about it have a guideline.”

As for the doctors who are performing these unnecessary procedures, Saini said there are “true believer” surgeons who insist that the procedure can benefit their patients despite a lack of evidence, “and there are those who are more skeptical. … But let’s be magnanimous and say that all of this comes from a place of wanting to help, and hope that it will help.”

“But if we’re really going to have a reliable, effective, and affordable healthcare system, we can’t just base it all on hope and a prayer,” he said. “It has to be based on evidence. Hope is easy to have, but in the end, it doesn’t solve the problem.”

The report also noted the high rate of complications from these procedures. Some 18% of spinal fusion procedures result in infection, blood clots, stroke, pneumonia, heart and lung problems, and in some cases, death.

The Lown Institute’s list was taken from Medicare data. The hospitals with the highest rates of spinal fusion/laminectomy overuse are Mount Nittany Medical Center in Pennsylvania (57.2% of 505 procedures), Concord Hospital in New Hampshire (39.5% of 517 procedures), and Lutheran Hospital of Indiana (38.6% of 1,232 procedures).

The hospitals with the highest rates of vertebroplasty overuse included Kettering Health Miamisburg in Ohio (56.1% of 578 procedures), Shannon Medical Center in Texas (54.6% of 694 procedures), and St. Elizabeth Florence Hospital in Kentucky (50.1% of 668 procedures).

The report also applauded hospitals with the lowest rates of these procedures. Avala Hospital in Louisiana, Northwest Specialty Hospital in Idaho, and Baylor Surgical Hospital at Las Colinas in Texas all had spinal fusion/laminectomy overuse rates of 1.2% or lower. Metrohealth Medical Center in Ohio, Harborview Medical Center in Washington, and the Mayo Clinic Health System-La Crosse were among 11 hospitals with no vertebroplasty overuse.

The hospitals with high rates of overuse have not returned a request for comment from MedPage Today.

The report also highlighted enormous state variation in rates of overuse of these procedures. California, Florida, Texas, and Pennsylvania had the highest amount of overuse of spinal fusion procedures, with at least 5,000 unnecessary procedures in each state. Texas, Florida, and Ohio had the highest volume of vertebroplasty overuse with at least 6,000 unnecessary procedures in each of those states.

Spinal fusion/laminectomy procedures were considered overused when performed for low back pain, but excluded patients with radicular symptoms, trauma, herniated disc, discitis, spondylosis, myelopathy, radiculopathy, radicular pain, or scoliosis.

Spinal fusion-only procedures were not considered overused when performed for stenosis with neural claudication and spondylolisthesis. Laminectomy-only interventions were not considered overused when performed in patients with stenosis who had neural claudication.

Vertebroplasty procedures were considered overused when performed in patients with spinal fractures caused by osteoporosis, but the list excluded patients with bone cancer, myeloma, or hemangioma.

The Medicare data included fee-for-service patients’ procedures from 2021 to 2023 and Medicare Advantage patients’ procedures from 2020 to 2022. Procedures performed on Medicare beneficiaries under age 65 were not included.

Saini said the report concentrated just on those hospitals that performed at least 500 of these procedures. For the spinal fusion/laminectomy analysis, 466 hospitals were evaluated, and for vertebroplasty, 625 hospitals were included.

He said these procedures are extremely expensive, costing $14,500 for spinal fusion and $4,200 for vertebroplasty.

Asked what efforts he thinks will reduce the number of these unnecessary back pain procedures, Saini suggested federal oversight, such as the WISeR (Wasteful and Inappropriate Service Reduction) model, could have a larger role, perhaps with more targeted prior authorization requirements or guidelines. Yet he acknowledged that pathway is extremely controversial.

“There’s no way we can replace clinical judgment of the physician in the exam room,” Saini said. “We can’t have the federal government practicing medicine.”

But a lot of clinicians “just aren’t with the program and some of them will argue with you until they’re blue in the face that the data just doesn’t refute the way they practice,” he said, noting the saying, “It’s hard to get somebody to understand something when their salary depends on them not understanding.”

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Is the “CURE” worse than the DISEASE?

Posted on October 9, 2025 by Pharmaciststeve

Risks of Tramadol Likely Outweigh Benefit for Chronic Pain

https://www.medpagetoday.com/neurology/painmanagement/117842

Drug didn’t meet efficacy threshold and doubled serious adverse event risk, analysis suggests

The opioid analgesic tramadol reduced chronic pain levels compared with placebo, but appeared to double the risk of harm, a review of 19 clinical trials suggested.

In a meta-analysis and trial sequential analysis, tramadol improved chronic pain on the numerical rating scale (NRS) with low certainty of evidence (mean NRS difference -0.93 points, 97.5% CI -1.26 to -0.60, P<0.0001), said Jehad Ahmad Barakji, MD, of the Centre for Clinical Intervention Research at Rigshospitalet in Copenhagen, Denmark, and co-authors.

The effect size was below the predefined minimal important difference of 1.0 point, Barakji and colleagues wrote in BMJ Evidence-Based Medicine. The NRS evaluates pain on a scale of 0 (no pain) to 10 (worst pain imaginable).

Tramadol also raised the risk of serious adverse events (OR 2.13, 97.5% CI 1.29-3.51, P=0.001) with moderate-certainty evidence, driven mainly by a higher proportion of cardiac events and neoplasms, the researchers reported. Non-serious adverse events like nausea, dizziness, constipation, and somnolence were higher with tramadol.

“Approximately 60 million individuals worldwide experience the addictive effects of opioids,” observed co-author Janus Christian Jakobsen, MD, PhD, also of the Centre for Clinical Intervention Research.

“Tramadol continues to be widely prescribed for the management of chronic pain and is often perceived as safer than other opioids, although this perception lacks supporting evidence,” Jakobsen told MedPage Today.

“The use of tramadol and other opioids should be minimized as much as possible,” he added. “Our study provides evidence in support of this recommendation.”

Tramadol selectively binds to various opiate receptors in the central nervous system, similar to other opioids. It was first approved as a non-controlled analgesic in 1995 under the brand name Ultram.

In 2014, the Drug Enforcement Administration classified tramadol as a schedule IV controlled substance, indicating it had a lower risk of abuse and dependence than schedule II opioids like oxycodone and hydrocodone.

Tramadol is approved to treat pain severe enough to require an opioid analgesic and carries a boxed warning for addiction and abuse, life-threatening respiratory depression, and other potential harms. Total prescriptions for tramadol-containing products in the U.S. totaled 27.1 million in 2024.

“Tramadol is an interesting drug because there is a sense among many clinicians that it isn’t really an opioid,” noted Molly Jeffery, PhD, of the Mayo Clinic in Rochester, Minnesota, who wasn’t involved with the analysis.

In 2019, Jeffery led a large U.S. insurance claims study that showed patients who used tramadol alone after surgery had a higher risk of prolonged opioid use than expected.

“If tramadol really is very different from other opioids we give people for acute pain, we might expect to see differences in long-term use of opioids in people who are prescribed tramadol versus other opioids after surgery,” Jeffery pointed out.

“We found the opposite was true; people who got tramadol rather than oxycodone or hydrocodone after their surgery were actually more likely to continue using opioids long-term,” she told MedPage Today.

Barakji and colleagues assessed data from 19 clinical trials involving 6,506 participants with chronic pain in their systematic review with meta-analysis and trial sequential analysis. Five trials evaluated tramadol for neuropathic pain, nine focused on osteoarthritis, four assessed chronic low back pain, and one involved fibromyalgia.

Participants were ages 47 to 69; their mean age was 58. All trials involved oral tramadol except one osteoarthritis trial that used topical administration.

Treatment duration ranged from 2 to 16 weeks, and follow-up spanned from 3 to 15 weeks. Eight trials assessed serious adverse events after follow-up periods that ranged from 7 to 16 weeks.

Serious adverse events in the tramadol groups included chest pain, coronary artery disease, congestive heart failure, prostate cancer, breast cancer, and thyroid neoplasm. The follow-up period for neoplasms was short, making a causal link between tramadol and new cancer disease “questionable at this point,” the researchers noted.

Five trials that evaluated tramadol’s effect on quality of life had mixed results; two found improvements, and three reported no significant differences between tramadol and placebo.

The study had several limitations, Barakji and co-authors acknowledged. “All included trials were at high risk of bias except two, which increases the likelihood that our findings overestimate the beneficial effects and underestimate the harmful effects of tramadol,” they wrote.

Several trials did not report the specific types of serious adverse events, and follow-up length varied across trials.

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The facts concerning the MME being a viable methodology for treating chronic pain

Posted on October 7, 2025 by Pharmaciststeve

can you elaborate why the MME system has no valid clinical basis for being used in treating chronic pain pts – especially intractable chronic pain pts. And elaborate on how observational studies cannot replace the reliability of a double blind clinical study with a control group

 

Let’s break down your two important points:

1. Morphine Milligram Equivalent (MME): Clinical Validity

The MME system is a way to compare doses of various opioids by converting them to a “morphine equivalent” value. This system was intended to help with opioid prescribing and safety policies, but using it as a rigid clinical tool—particularly for patients with chronic or intractable pain—has major problems:

  • MME Ratios Are Estimates: Conversions between different opioids are based on population averages and not on robust, head-to-head clinical trials. They ignore big differences in individual metabolism and response.

  • Lack of Accounting for Tolerance & Variability: Two patients on the same MME dose may have very different pain relief or risk of side effects.

  • No Validation for Chronic Use: MME tables were derived mainly from studies on acute pain or end-of-life care, not from well-controlled trials in treating chronic, stable pain patients.

  • Intractable Pain Complexity: Patients with intractable pain often require long-term, stable dosing, and conversion tables don’t reflect the clinical nuances or needs of this population.

Key point: There is no strong clinical evidence—no large, well-designed, double-blind, controlled trials—showing that fixed MME thresholds reduce overdoses or improve outcomes in chronic pain management.

2. Observational Studies vs. Double-Blind Controlled Trials

  • Observational studies look at correlations or trends in real-world data. They can suggest possible risks or associations but cannot prove causation. For example, they might show that higher MME doses are associated with overdose, but they can’t control for all factors (like patient frailty, disease severity, or other medications).

  • In contrast, a double-blind, randomized controlled trial (RCT) assigns patients to treatments randomly and hides the assignment from both providers and patients. This design is considered the gold standard for minimizing bias and isolating the actual effect of the intervention.

Summary:

  • Observational studies can generate hypotheses, but they can be heavily confounded by outside variables. They CANNOT establish a reliable cause-and-effect relationship.

  • Policy decisions about pain management—like rigid MME limits—should be based on evidence from controlled trials, not observational trends alone.

Quick check: Can you restate, in your own words, the difference between what an observational study can tell us, and what a double-blind randomized controlled trial (RCT) is designed to show?

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