NO ONE IS ABOVE THE LAW -EXCEPT THOSE WHO ARE IN CHARGE OF ENFORCING OUR LAWS

Posted on April 29, 2025 by Pharmaciststeve

Read this and weep – AGs and National Opioid Agreement – nicely put CPs OUT IN THE COLD  It would appear that many different parts of our federal and state bureaucracy are focusing on cutting the availability of FDA-approved controlled opioids. I guess that the DOJ/DEA was not shutting down practitioners’ offices fast enough.  More and more people were being poisoned/dying by illegal Fentanyl, but the media keeps referring to all the deaths are from JUST FENTANYL. Never mind that all the lethal illegal fentanyl was coming from CHINA & MEX CARTELS.  So the NATIONAL OPIOID AGREEMENT was to get the wholesalers to RATION OPIOIDS to community pharmacies.

STILL NOT FAST ENOUGH. Now, someone has talked the FDA into attempting to remove all extended-release opioid medications from being available.  Opioid medications have been commercially available in the United States for well over a century. If one reads the “fine print” on the website to place your comment. Comment Period Ends: May 4, 2025 at 11:59 PM EDT

We have an estimated 30% of the population dealing with chronic pain. Just imagine how many chronic painers can hold down a job because of long-acting opioids, and if they lose their long-acting opioids, many may end up on Medicare disability. We all know just how generous Medicare disability payments are! Just imagine how many chronic painers will not be able to get a good night’s restorative sleep.

MY MONEY IS ON THE FACT THAT AG PAM BONDI WILL DO NOTHING ABOUT DENYING CHRONIC PAINERS ACCESS TO FDA-APPROVED PAIN MEDICATION

 

Below is a federal law signed into law in 1935 – 35 years BEFORE the CONTROLLED SUBSTANCES ACT was signed into law. I am not an attorney, but  42 USC 1395 would seem to indicate that anyone in the federal government is prohibited from interfering with the practice of medicine.  Regardless of this nearly century-old law, the DOJ/DEA is repeatedly doing just that – over and over and over again.

Is AG Pam Bondi going to arrest some of the people within her DOJ agency for violating many federal laws? She is shown in the above video, where she is talking about arresting judges who are under her DOJ agency and have broken a few federal laws.

 Here is one of Pam Bondi’s re-election TV ads – running for FL AG – from about 10 yrs ago.

Dr Ruan and Dr Meredith Taking out the best of us to terrify the rest

Why was the SCOTUS (9-0) ruling on Ruan/Kahn a non-starter?

The June 2022 SCOTUS ruling that the DEA must NOT USE OBJECTIVE CRITERIA in judging prescribers in what they prescribe to pts dealing with SUBJECTIVE CRITERIA.

42 USC 1395: Prohibition against any Federal interference

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.

(Aug. 14, 1935, ch. 531, title XVIII, §1801, as added Pub. L. 89–97, title I, §102(a), July 30, 1965, 79 Stat. 291 .)

Statutory Notes and Related Subsidiaries

Short Title

For short title of title I of Pub. L. 89–97, which enacted this subchapter as the “Health Insurance for the Aged Act”, see section 100 of Pub. L. 89–97, set out as a Short Title of 1965 Amendment note under section 1305 of this title.

Protecting and Improving Guaranteed Medicare Benefits

Pub. L. 111–148, title III, §3601, Mar. 23, 2010, 124 Stat. 538 , provided that:

“(a) Protecting Guaranteed Medicare Benefits.-Nothing in the provisions of, or amendments made by, this Act [see Short Title note set out under section 18001 of this title] shall result in a reduction of guaranteed benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].

“(b) Ensuring That Medicare Savings Benefit the Medicare Program and Medicare Beneficiaries.-Savings generated for the Medicare program under title XVIII of the Social Security Act under the provisions of, and amendments made by, this Act shall extend the solvency of the Medicare trust funds, reduce Medicare premiums and other cost-sharing for beneficiaries, and improve or expand guaranteed Medicare benefits and protect access to Medicare providers.”

The FDA is about to make decisions that could permanently damage pain care in the United States … again.
On May 5th, a joint FDA advisory meeting will review two key studies (PMR 3033-1 & 3033-2) supposedly assessing the risks of extended-release/long-acting (ER/LA) opioid medications.
One of the many problems?
Neither of the studies has been made fully available for public review.
Stakeholders – patients, providers, researchers – are being asked to comment blindly on data that could determine access to critical medications for millions of Americans.
This is a textbook example of a process that violates transparency, scientific integrity, public trust, and possibly even federal law.
Even more concerning:
•The studies measure only risks (like misuse or overdose), but completely ignore benefits like improved quality of life, stability, and functionality for legitimate patients.
•Advocates tied to the anti-opioid lobby are pushing for redefinitions of opioid use disorder that could pathologize stable, compliant patients simply for needing medication.
•The Supreme Court’s recent overturning of Chevron Deference (Loper Bright v. Raimondo) means that regulatory decisions based on hidden, vague, or one-sided data are now more vulnerable to legal challenge. Agencies must get it right – or face judicial scrutiny.
I submitted my official comment when they briefly opened the docket back up.
We need as many voices as possible telling the FDA:
•No decisions should be made based on unpublished, incomplete, or opaque data
•Patient outcomes, functionality, and real-world harm must be included in any benefit / risk assessment
•Regulatory policy must not be driven by citation cartels or manufactured narratives
I’ve posted a couple of simple and brief templates you can use if you want to submit a comment quickly and easily. (Click here to go to my highlight section on X: https://x.com/impact2heal?s=21)
The deadline to be heard before the May 5th meeting is April 28th at midnight eastern time (8pm pacific time), so time is short. Even worse, the server is down currently until Monday so you’ll have to watch for the brief time between them opening back up and this docket closing.
We cannot afford silence.
Please watch for my next post and join us in defending ethical, transparent healthcare policy.
(Here is the link to read this docket yourself and to comment: https://www.regulations.gov/docket/FDA-2024-N-5331)

Filed under: General Problems | Leave a Comment »

New Blood Pressure Guidelines Lower Treatment Target

Posted on April 28, 2025 by Pharmaciststeve

Apparently, the author of this article did not wish to call out what is still a hypertensive crisis level. Which it is a BP of > 180/120.

I can’t count the number of times that a pt has told me that after their pain meds have been reduced and their blood pressure would go up to > 200/100.  Unfortunately, many pts often state that the pain doc will claim that they don’t treat blood pressure, and the pt’s PCP or Cardiologist claims that they don’t treat pain.

The graphic to the lower left indicates the potential medical consequences that a pt may experience if the pt’s blood pressure is not treated and reduced to a more acceptable/recommended level.

 

 

New Blood Pressure Guidelines Lower Treatment Target

LONDON — Simplified and more aggressive targets are among the significant changes to the updated hypertension guidelines released by the European Society of Cardiology.

For most treated patients, the new systolic blood pressure goal is a target of 120 mm Hg to 129 mm Hg, which is a move away from the previous two-step recommendation.

Although the updated guidelines, presented here at the ESC Congress, continue to define hypertension as a systolic BP of at least 140 mm Hg and a diastolic BP of at least 90 mm Hg, there is a new category — elevated BP. This is defined as a systolic BP of 120 mm Hg to 139 mm Hg or a diastolic BP of 70 mm Hg to 89 mm Hg and cardiovascular risk assessment is advised to guide treatment, particularly in patients with a BP of at least 130/80 mm Hg.

The guidelines also introduce new recommendations for lifestyle options to help lower BP, including changes to exercise advice and the addition of potassium supplementation. And for the first time, the ESC guidelines provide recommendations for the use of renal denervation to treat hypertension in certain circumstances.

The guidelines were produced by an international panel, led by Bill McEvoy, MB BCh, from the University of Galway, Ireland, and Rhian Touyz, MB BCh, PhD, from McGill University in Montreal.

Three Categories of Blood Pressure

There are now 3 categories for BP classification — non-elevated (<120/70 mm Hg), elevated (120 mm Hg to139 mm Hg/70 mm Hg to 89 mm Hg), and hypertension (≥140/90 mm Hg) — McEvoy reported during a session on the new guidelines here at ESC.

The emphasis on out-of-office BP measurement is stronger than in previous guidelines, but office measurement will still be used, he said.

All patients in the hypertension category qualify for treatment, whereas those in the new elevated BP category will be subject to cardiovascular risk stratification before a treatment decision is made.

Patients in the elevated BP category who also have moderate or severe chronic kidney disease, established cardiovascular disease, diabetes, or familial hypercholesterolemia are among those considered at increased risk for cardiovascular disease, as are patients with an estimated 10-year cardiovascular risk of 10% or higher. In such patients with a confirmed BP of at least 130/80 mm Hg, after 3 months of lifestyle intervention, pharmacologic treatment is recommended.

“This new category of elevated blood pressure recognizes that people do not go from normal blood pressure to hypertensive overnight,” McEvoy said. “It is, in most cases, a steady gradient of change, and different subgroups of patients — for example, those at a higher risk of developing cardiovascular disease — could benefit from more intensive treatment before their blood pressure reaches the traditional threshold of hypertension.”

New Lower Target

The major change in target pressures in these guidelines is based on new clinical trial data that confirm that lower pressures lead to lower cardiovascular event rates, resulting in the new systolic BP target of 120 mm Hg to 129 mm Hg for most patients receiving antihypertensive medications.

This systolic target represents a major change from previous European guidelines, McEvoy said, which have generally recommended that patients be treated to a target of less than 140/90 mm Hg and, only after that has been reached, then treated to a target of less than 130/80 mm Hg (a two-step approach).

“This change is driven by new trial evidence confirming that more intensive blood pressure treatment targets reduce cardiovascular outcomes across a broad spectrum of eligible patients,” McEvoy said.

There are, however, several caveats to this recommendation, including the requirement that treatment to this target be well tolerated; more lenient targets can be considered in people with symptomatic orthostatic hypotension, those 85 years and older, and those with moderate to severe frailty or a limited life expectancy. For these patients, the guidelines recommend a target “that is as low as reasonably achievable.”

More in Line With US Guidelines

The new European guidelines are now more in line with the American guidelines, said Eugene Yang, MD, from the University of Washington in Seattle, who is chair of the Hypertension Writing Group at the American College of Cardiology.

“These new European guidelines have thoughtfully used the latest study data to simplify recommendations for a specific lower blood pressure target. This is a step forward. There is now a greater alignment of European and US guidelines. This is good to reduce confusion and build consensus across the world,” he said.

Both sets of guidelines now recommend a BP target of less than 130/80 mm Hg for most people. 

“I think the Europeans have now embraced this more aggressive target because there are many more studies now showing that these lower blood pressure levels do lead to a reduction in cardiovascular events,” Yang explained. “When the last European guidelines came out, there was only SPRINT. Now there are several more studies showing similar results.”

New Lifestyle Advice

The updated recommendation of 75 minutes of vigorous-intensity aerobic exercise per week has been added as an alternative to the previous recommendation of at least 2.5 hours per week of moderate-intensity aerobic exercise. This should be complemented with low- or moderate-intensity dynamic or isometric resistance training two to three times a week. 

It is also recommended that people with hypertension, but without moderate or advanced chronic kidney disease, increase potassium intake with salt substitutes or diets rich in fruits and vegetables.

Renal Denervation Included for First Time 

For the first time, the guidelines include the option of renal denervation for the treatment of hypertension — at medium- to high-volume centers — for patients with resistant hypertension that is uncontrolled despite a three-drug combination.

However, renal denervation is not recommended as a first-line treatment because of the lack of evidence of a benefit in cardiovascular outcomes. It is also not recommended for patients with highly impaired renal function or secondary causes of hypertension.

Yang said he approves of the inclusion of a frailty assessment in the new guidelines and less aggressive targets for people who are in poor health and older than age 85 years, but added that, “on the whole, they have less age-specific stratification than before, which is a significant change, and a good one in my view.” 

Again, this is like the American guidelines, which have no age cutoffs and a target of less than 130/80 mm Hg for all, with the caveat that clinical judgment may be needed for individuals who are institutionalized, he added.

Yang said he was not as keen on the requirement for a cardiovascular risk assessment to guide treatment decisions for people with a systolic BP in the 130 mm Hg to 139 mm Hg range, although this is also included in the current American guidelines.

“As a clinician, I think this complicates things a bit too much and, as such, will be a barrier to treatment. In my view, blood pressure treatment recommendations need to be as simple as possible, so I think we still have some work to do there,” he said.

Filed under: General Problems | Leave a Comment »

The Coming Pharma Tariffs: Decoding Trump’s High-Stakes Bet on Drug Supply Chains

Posted on April 26, 2025 by Pharmaciststeve

The Coming Pharma Tariffs: Decoding Trump’s High-Stakes Bet on Drug Supply Chains

https://www.daily-remedy.com/the-coming-pharma-tariffs-decoding-trumps-high-stakes-bet-on-drug-supply-chains/

As former President Trump signals sweeping tariffs on foreign pharmaceuticals, policymakers, investors, and patients must brace for consequences that go far beyond price tags

Introduction: The Tariff Test Case No One Is Talking About

For all the attention given to tariffs on steel, aluminum, and semiconductors, one of the most disruptive trade proposals on the horizon has remained oddly underdiscussed: Donald Trump’s plan to impose sweeping tariffs on foreign-made pharmaceuticals. Framed as a populist push to bring drug manufacturing back to U.S. soil, the policy is gaining traction on the campaign trail—and raising alarms among economists, health policy experts, and pharmaceutical executives alike.

While the former president has not yet detailed a full plan, multiple sources close to his economic advisory circle confirm that the groundwork is being laid for a 10–20% blanket tariff on all pharmaceuticals imported from key trading partners, including China and India. These two countries, it should be noted, account for over 70% of the active pharmaceutical ingredients (APIs) used in U.S.-consumed drugs.

The rationale is politically intuitive: punish foreign competitors, reward domestic production, and make America less reliant on hostile supply chains. But beneath the surface, the implications are far murkier—and potentially more dangerous.

This is not just a trade issue. It is a test case in how globalized health economics, domestic populism, and national security concerns collide—with patients, as always, caught in the crossfire.

The Supply Chain We Forgot We Had

To understand how Trump’s pharma tariffs might land, we need to revisit how the modern pharmaceutical supply chain operates.

Unlike consumer electronics or automobiles, where parts may be assembled in one location and finished elsewhere, pharmaceutical manufacturing is largely decentralized and opaque. APIs—the raw chemical compounds that make drugs effective—are often produced in China and India due to lower environmental regulations and cheaper labor costs. From there, they are shipped to contract manufacturers, often in Europe or Puerto Rico, who formulate the final product. Only a fraction of these processes occur on U.S. soil.

This design wasn’t an accident. It was driven by decades of globalization, in which efficiency and cost-saving trumped domestic capacity. But the COVID-19 pandemic exposed just how brittle this system had become.

During the early days of the pandemic, U.S. hospitals saw shortages of common medications—anesthetics, antibiotics, even basic painkillers—not because the drugs were too expensive, but because they were stranded on ships or behind closed ports. Trump’s tariffs are, in part, a reaction to that vulnerability.

But they also risk weaponizing a problem that requires surgical precision—not political bluster.

The Economics of a Blunt Instrument

A 15% tariff on foreign pharmaceuticals may sound like a modest policy shift. But even small changes in upstream drug pricing can ripple across the healthcare system in disproportionate ways.

For starters, U.S. pharmaceutical companies often rely on foreign-produced APIs even when the final drug is branded “Made in America.” A blanket tariff would raise costs for manufacturers across the board—regardless of where the final pill is pressed.

Then there’s the issue of generics. Around 90% of prescriptions filled in the United States are generics, many of which are produced entirely overseas or with imported components. The generics market operates on razor-thin margins, and a tariff could either force suppliers to withdraw from the market or pass the costs onto consumers.

“You’re essentially taxing the cheapest drugs we have,” said Dr. Matthew Lang, a health economist at George Washington University. “And those are the drugs most Americans depend on daily.”

Insurers, pharmacy benefit managers, and Medicare administrators would face tough choices: absorb the increased cost, restrict formularies, or shift the burden to patients through higher copays.

Whichever path is chosen, the result could be the same: higher out-of-pocket costs and less access—especially for low-income and elderly populations.

National Security or Economic Nationalism?

Proponents of the tariffs argue that national security justifies the cost. They point to a 2020 report from the U.S.-China Economic and Security Review Commission that warned of America’s overdependence on foreign drug manufacturing, particularly in geopolitical flashpoints like China.

There is truth to this concern. China dominates the global supply of antibiotics and other critical medications. India, for its part, relies heavily on Chinese APIs. A strategic disruption in this chain—whether due to conflict, pandemic, or economic coercion—could leave the U.S. vulnerable.

Yet critics argue that tariffs are a clumsy way to address this problem. “Tariffs don’t build factories,” said Janet Kuo, an analyst with the Brookings Institution. “They just make existing products more expensive. If the goal is to re-shore production, then we need targeted subsidies, public-private partnerships, and FDA support for domestic startups—not taxes on patients.”

Moreover, there is no guarantee that domestic producers could ramp up quickly or cheaply. Drug manufacturing requires not only infrastructure but regulatory clearance, quality assurance, and skilled labor—none of which can be imported on short notice.

Political Chess Meets Policy Roulette

If the tariffs do move forward, expect the political battle to be fierce. Democrats will likely attack the policy as reckless and anti-consumer, while some Republicans—particularly those aligned with libertarian or pro-business wings—may resist on grounds of economic orthodoxy.

The pharmaceutical lobby, already bruised from years of price-control debates, is expected to mount a robust defense. But they may face an uphill battle in an election year where “bringing jobs home” remains a potent talking point.

As with many Trump-era economic policies, the goal may not be policy coherence but political messaging. “Tariffs are a way of drawing lines,” said political scientist Nora Greenberg. “You’re either with American workers or against them. That binary appeals to voters—even if the actual impact is far more complex.”

Preparing for the Impact

While the tariffs are not yet law, stakeholders across the healthcare spectrum should begin contingency planning now.

  • Health systems should audit their drug inventories and assess vulnerability to foreign supply chain shocks.
  • Policymakers should consider emergency authorization protocols or supply chain incentives to buffer critical drug access.
  • Patients should be informed, not just alarmed. Transparency around potential price increases and generic availability will be crucial in the months ahead.

There is still time to shape the outcome. Congressional hearings are likely. International partners may seek exemptions or retaliate with their own tariffs. And perhaps most significantly, Trump’s return to power—if it happens at all—remains an open question.

But the broader lesson is already clear: Globalized healthcare comes with globalized risks. And when political solutions are crafted without systemic understanding, the costs are rarely paid by policymakers. They are paid by patients.

Filed under: General Problems | Leave a Comment »

A camp for kids with CHRONIC PAIN

Posted on April 25, 2025 by Pharmaciststeve

Kids with chronic pain can become extremely isolated as peers often do not understand and friendships suffer. Please share this incredible online camp with anyone who might benefit! Courageous Parents Network Effie Parks Elan Schneider

As a nonprofit working with young people in pain, we’re excited to share an incredible resource from CHYP: A free online summer camp for teens (ages 13–18) living with chronic pain.

This camp offers a safe, creative, and Spoon Theory-informed environment where youth can explore artistic expression, connect with peers who understand their experiences, and participate in low-pressure activities—all from the comfort of home.

Pain can be isolating, especially for adolescents. This camp helps break that isolation by offering community, compassion, and creativity in a format that honors each participant’s energy and capacity.

If you work with youth experiencing chronic pain, we encourage you to share this opportunity with families in your care.

📅 Free & virtual
🧠 Designed with chronic pain in mind
🎨 Centered on creativity, connection, and healing

Learn more + refer a family: https://lnkd.in/gexQSDAB
Email us for access to the full flyer to share with your community: admin@mychyp.org

freeresource summercamp chronicpain creativehealing

Filed under: General Problems | Leave a Comment »

LIFE-LIBERTY-JUSTICE FOR ALL – LAND OF THE FREE & HOME OF THE BRAVE

Posted on April 24, 2025 by Pharmaciststeve

 

I had an interesting conversation today. Our PCP called in Barb’s opioid Rx in Monday or Tuesday. The independent pharmacy that we patronize called us and said that their drug wholesaler – one of the BIG THREE MAJORS – did not have her particular med in stock & it was in back order.

I know who the drug wholesaler that they use. So I called their corporate HQ.  I got to someone in their customer service area. I told the gentleman that I was trying to confirm that they had no inventory of a particular C-2. He first told me that I was not a customer of the wholesaler, and he could not tell me if they had inventory.

I asked if he could transfer the call to someone who is his supervisor and could share that information?  Surprisingly, this young man suddenly had the authority to provide me if they had any inventory on hand.

He stated that they had no inventory on hand. I asked him how many pharmas that makes this particular product, did they normally have it in inventory ?  I was told that they normally had the product from NINE DIFFERENT PHARMAS. I asked if they had an inventory on the next higher strength.  I knew that even though this was a extended release – long acting – dose that they could be split in half without interfering with the long-acting property. I then called our pharmacy and they checked the wholesaler’s inventory for the higher strength – but they only had CAPSULES – which you can’t split.

This guy had no information on when any of the strength that Barb needs would become available.

I have no way to check, but the THREE MAJOR DRUG WHOLESALERS control some 80% of the entire Rx marketplace. So I would not be surprised if all three of these wholesalers are also without inventory.

Barb has a implanted pump, so she can “survive” without one of the two oral opioids that she takes. I feel sorry if all those chronic pain pts that can’t refill their Rxs more than two days early and will soon be thrown into cold turkey withdrawal.

Filed under: General Problems | 5 Comments »

Why doesn’t the FDA using MME in professional literature on dosing a opioid

Posted on April 23, 2025 by Pharmaciststeve

Why doesn’t the FDA use MME in professional literature on dosing an opioid

The FDA does not routinely use Morphine Milligram Equivalents (MME) in its professional literature for opioid
dosing for several key reasons:
– **Variability in Conversion Factors:** MME conversion tables are based on data from small clinical studies
in limited populations, and different resources (tables, calculators) may use different conversion factors for the
same opioid. This lack of standardization can lead to inconsistencies and potential dosing errors when applied
broadly[5].
– **Patient and Drug Differences:** The pharmacokinetics and pharmacodynamics of opioids can vary widely
among individuals due to factors like opioid tolerance, genetics, age, organ function, and concurrent
medications. Some opioids (e.g., partial agonists like buprenorphine or novel agents like tapentadol) do not fit
neatly into the MME system, making it unreliable for all clinical scenarios[5].
– **Intended Use of MME:** The original purpose of MME was to provide a rough guide for clinicians when
converting from one opioid to another, not as a precise tool for dosing or setting rigid prescribing thresholds[5].
Over time, MMEs have been increasingly used by policymakers and payers to set limits, but these uses may not
reflect the nuances required for individual patient care.
– **Risk of Misapplication:** The FDA and CDC have both cautioned that applying MME thresholds as rigid
standards can lead to unintended consequences, such as under-treatment of pain or abrupt discontinuation of
opioids in patients who may benefit from them. Clinical guidelines now emphasize individualized care and warn
against using MME cutoffs as inflexible rules[1][5].
– **Epidemiologic vs. Clinical Use:** While epidemiologic studies have shown that higher daily MME doses
are associated with increased overdose risk, there is no universally agreed-upon MME threshold that defines
“safe” versus “unsafe” prescribing. The FDA recognizes that MME is useful for population-level risk
assessment but not as a precise clinical dosing tool[5].

In summary, the FDA avoids emphasizing MME in professional dosing literature because of its limitations in accuracy, variability among individuals and drugs, and the risk of misapplication in clinical practice. Instead, the FDA and other agencies encourage individualized, evidence-based opioid prescribing that considers the unique needs and risks of each patient[1][5].

Citations:
[1] https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm
[2] https://www.ncbi.nlm.nih.gov/books/NBK458653/
[3] https://www.fda.gov/media/147152/download
[4] https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm
[5] https://www.fda.gov/media/150436/download
[6]
https://www.fda.gov/drugs/news-events-human-drugs/morphine-milligram-equivalents-current-applications-and
-knowledge-gaps-research-opportunities-and
[7]
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-prescribing-information-all-opioid-pain-me
dicines-provide-additional-guidance-safe-use
[8] https://www.fda.gov/media/126835/download
[9]
https://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-updates-prescribing-information-all-opioid-pain-medici
nes-provide-additional-guidance-safe-use
[10] https://www.healthvermont.gov/sites/default/files/document/reg-prescribing-opioids.pdf
[11] https://www.ncbi.nlm.nih.gov/books/NBK551720/
[12] https://www.ncbi.nlm.nih.gov/books/NBK572085/
[13] https://health.ri.gov/addiction-overdose/safe-opioid-prescribing
[14] https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019813s033lbl.pdf
[15] https://www.ncbi.nlm.nih.gov/books/NBK458654/
[16] https://mn.gov/dhs/opip/opioid-guidelines/pain-phase/acute-pain.jsp
[17] https://healthandwelfare.idaho.gov/providers/opioid-use-disorder/opioid-prescribing
[18] https://mn.gov/dhs/opip/opioid-guidelines/pain-phase/chronic-pain.jsp
[19]
https://www.fda.gov/drugs/food-and-drug-administration-overdose-prevention-framework/timeline-selected-fda
-activities-and-significant-events-addressing-substance-use-and-overdose
[20] https://www.hca.wa.gov/assets/billers-and-providers/opioid-policy.pdf
—
Answer from Perplexity: pplx.ai/share

 

 

Filed under: General Problems | 4 Comments »

LAB LEAK: the true origins of COVID-19

Posted on April 22, 2025 by Pharmaciststeve

The hyperlink below is just a link to a 557-page report from the WHITE HOUSE on the COVID-19 Crisis. Of course, the highlight of the entire 4 yrs crisis and a copy of the pardon that President Biden gave Anthony Fauci for his contributions to the COVID-19 crisis.

 

https://www.whitehouse.gov/lab-leak-true-origins-of-covid-19/?utm_source=wh_social_share_button

 

 

 

 

 

 

 

 

Filed under: General Problems | Leave a Comment »

Morphine Milligram Equivalents: The Metric Obscures the Mission

Posted on April 22, 2025 by Pharmaciststeve

Morphine Milligram Equivalents: The Metric Obscures the Mission

https://www.acsh.org/news/2025/04/14/morphine-milligram-equivalents-metric-obscures-mission-49415

Welcome to the world of opioid prescribing, where government mandates based upon Morphine Milligram Equivalents (MMEs) are the rule rather than clinical judgment. In the zeal to fight the risk of opioid addiction, policymakers chose a metric — then forgot what it was meant to measure.

Generated by AI

“You can’t manage what you can’t measure.” 

While this statement by business sociologist Peter Drucker is certainly true, in some scientific or regulatory instances, it is impossible to measure what you seek to manage. Proxies are measurable and, when strongly correlated with our goal, useful. Proxies can simplify complex problems, allow for performance tracking, and deliver faster feedback. But poorly chosen proxies derail the very goals they’re meant to support.

A Poorly Chosen Proxy

In the opioid wars, Morphine Milligram Equivalents (MMEs) became the proxy of choice. Easily measured, easy to regulate, and track—MMEs appear whenever a prescription is filled. So, it made sense, on the surface, to use MMEs to simplify the goal of reducing opioid prescribing.

Unfortunately, the goal of reducing opioid prescribing is, in fact, a proxy for an even more difficult goal: the reduction of prescription-related substance use disorder. 

MMEs, now a proxy for a proxy—lose their strength of correlation and usefulness, succumbing to the proxy’s pitfalls: misalignment, unintended consequences, and oversimplification. More specifically, the use of MMEs in the war on opioid addiction and overdoses has resulted in unintended harm to individuals afflicted with chronic pain, oversimplifying the clinical nuances of addiction allowing bureaucrats to count pills instead of understanding patients. 

It is a painful demonstration of Goodhart’s Law, 

“When a measure becomes a target, it ceases to be a good measure.”

A new study in JAMA Network Open drives home the disconnect between proxy metrics and meaningful outcomes.

The Law That Capped Judgment

In 2016, New York implemented a limit to the initial prescription of opioids for acute pain to 7 days, stripping any discretion, i.e., clinical judgment, by physicians. The New York law, known as Section 3331, joined 39 other states in state opioid cap laws (SOCLs) aimed at: 

  • Reducing the risk of addiction by limiting opioid use
  • Reducing unused opioids that could be “diverted” for misuse

The research involving Medicare beneficiaries looked at prescribing behavior before and after implementing New York’s SOCL Section 3331 for individuals undergoing total joint replacement (TJR). As they write, 

“Adequate post-TJR pain control is a key marker of successful surgery, and inadequate control is associated with impaired recovery, resulting in delayed or unmet physical therapy milestones, increased health services use, and reduced quality of life.”

California, which had the highest number of Medicare TJRs and no SOCL, served as a control. The primary endpoint was the total MMEs filled after discharge. They considered the first 7 days after surgery and 30- and 90-day intervals consistent with the law and “key clinical practice milestones.” [1]

The patient cohort included 85,000 Medicare beneficiaries undergoing 93,000 total joint replacements, roughly a third being treated before New York’s SOCL implementation. The mean age was 73; 60% were women, and 89% were White.

The Data Speaks

  • As the graph demonstrates, both states had similar significant declines in opioid prescribing throughout the 90-day post-operative period. The decrease in NY was 47%, and in California, 43%.
  • In that initial 7-day period, the number of prescriptions filled and the quantity of opioids prescribed were reduced more so in New York than California.
  • While the likelihood of patients filling at least one opioid prescription within 7 days after surgery dropped in California (−7.76 %) and New York (−5.27 %), paradoxically, Section 3331 resulted in a relative increase in opioid fills compared to California and more fills during the subsequent 31 to 90-day recovery period.

“Overall, our findings suggest that Section 3331 may have achieved its intended objective of reducing opioid prescribing for acute pain in the short-term 7-day post-TJR period.” [emphasis added]

However, that’s where the success story ends. The unstated but actual goal, reducing prolonged opioid exposure, addiction risk, and leftover meds for diversion—remained unmeasured and possibly unmet. Exposure was longer in New York when those later refills are counted. And we have no data on addiction, diversion, or patient satisfaction.

What’s Missing from the Metrics

Most critically, the focus on the proxy, MMEs prescribed, left “meaningful changes in the pain needs of patients, morbidity, or mortality for future research.” The increase in refills after the initial 7 days is ambiguous. Do they suggest the persistence of pain requiring longer treatment or reflect misuse or diversion? Refills tell us nothing about “risky” behavior. 

We don’t know—because the measure we chose can’t tell us.

Goodhart’s Law In The Real World

Goodhart’s Law manifests itself in many ways, as this study demonstrates. MMEs are too simple a measure of the complexity of real-world prescribing that is a confluence of practitioner beliefs, institutional protocols, and policy environment. California’s trends in prescribing behavior were nearly identical to New York’s, without the benefit or limitations of SOCL. MMEs fail because they are correlates, not causes. MMEs are a rough measure of opioid exposure, at best, a risk factor among many for substance use disorder. 

They are neither a measure of pain management nor relief. MMEs also allow for gaming the system. Prescribers might under-treat pain out of fear—or overprescribe to avoid complaints—neither of which addresses patient well-being. Proxies distort behavior and, as Goodhart suggests, undermine intended outcomes. 

Recognizing these pitfalls, one might hope for mitigation strategies. That could include:

  • Thoughtful consideration of downstream unintended consequences,
  • Choosing metrics more closely aligned with desired outcomes
  • Using balanced targets, e.g., MME, pain scores, and diagnosis of substance use disorders, to expose the real trade-offs and discourage gaming. 

Unfortunately, legislation is drawn in blacks and whites, and rarely are clinicians invited to the table. Researchers are equally culpable for using available data rather than more costly, in time and money,  bespoke data. These researchers write that “much work remains to restrict opioid prescribing in the later post-TJR period, suggesting there is an opportunity to refine Section 3331 to reduce perioperative prescribing.” This refines the proxy and does little for the clinical outcomes of safe pain management and lowered addiction risk. 

Proxy metrics like MMEs were never designed to bear the weight of legislation, yet we keep piling on. In chasing numbers, we lose sight of patients—of pain that goes untreated, of addiction risks that go unmeasured, of policies that solve for optics instead of outcomes. 

Real patients suffer when we treat metrics as medicine.

If we want better results, we need better questions, metrics, and a better understanding of what and who we’re actually trying to heal.

[1] Secondary endpoints included MMEs per prescription and day, number of refills and the likelihood of at least one opioid fill, the likelihood of an opioid prescription longer than 7 days, and total opioids prescribed.

Filed under: General Problems | Leave a Comment »

Update on the trial of Dr Neil Anand, and pending legal stuff for DrMark

Posted on April 22, 2025 by Pharmaciststeve

Filed under: General Problems | 4 Comments »

isolating “pure” cases remains methodologically challenging for the FDA and CDC -so they use “dirty data” to support their conclusions

Posted on April 22, 2025 by Pharmaciststeve

I asked www.perplexity.ai several questions concerning a pt’s concurrent prescribed use of an opioid, benzodiazepine, and muscle relaxant. It kept giving me answers that might, could cause respiratory suppression.  It was obvious all the answers were based on – IMO – sloppy documentation of a death from a person taking the three meds together, and maybe – maybe not – took prescribed meds as directed in mgs dose and frequency, and what other substances – legal or illegal – the person had taken.

Statistics can be your friend or your enemy. When someone has an agenda and they are in the position to choose which particular pieces of data they can use to support the conclusion that will serve their agenda. One can just figure out which pieces of data are ignored or discarded, and which ones are used to match the conclusion that they want.

Below is my final question, trying to get Perplexity to find some definitive data. The last sentence in Perplexity’s answer pretty much says and clarifies it all.

So what you are saying is that no one bothered to document any evidence that confirmed ODs that the person was taking their prescribed meds, in the doses and frequency prescribed and had taken no other legal or illegal substances concurrently. Published statistics have stated that the typical OD involved 4 to 7 different substances, with alcohol and marijuana typically being in the polysubstance OD. While all three classes of meds will suppress respiration, but is suppression at therapeutic doses typically fatal – can you provide clinical studies that shows a high probability of it being fatal

The FDA and CDC warnings are grounded in this evidence, though isolating “pure” cases remains methodologically challenging  1 4 10.

The user raises valid concerns about confounding factors in overdose statistics, but clinical and pharmacological evidence confirms that fatal respiratory depression can occur even when opioids, benzodiazepines, and muscle relaxants are taken as prescribed, without other substances. Here’s the breakdown:

1. Evidence from Prescribed-Use Cohorts

  • FDA’s 2016 Analysis (prescribed regimens):

    • Patients co-dispensed opioids + benzodiazepines had a 10x higher overdose death rate (7.0 vs. 0.7 per 10,000 person-years) compared to opioids alone1.

    • 31% of opioid overdose deaths involved benzodiazepines, with no requirement for supratherapeutic dosing18.

  • Veterans Health Study:

    • Patients prescribed opioids + benzodiazepines had a 3.86x higher fatal overdose risk vs. opioids alone, even after adjusting for dose and comorbidities18.

2. Pharmacodynamic Synergy at Therapeutic Doses

  • Respiratory Depression Mechanism:

    • Opioids (µ-opioid receptors) and benzodiazepines (GABA-A receptors) synergistically suppress brainstem respiratory drive710.

    • Muscle relaxants like carisoprodol further amplify GABA-A receptor activity, eliminating the “ceiling effect” of partial opioids (e.g., buprenorphine)109.

    • Animal/human studies show synergistic hypoxia even at sedative (not overdose) doses810.

3. Limitations in Isolating “Pure” Cases

  • Polysubstance Overdose Prevalence:

    • Most fatal overdoses involve 4–7 substances (e.g., alcohol, illicit drugs), complicating isolation of prescribed triple-therapy fatalities79.

  • Indirect Evidence from Hospitalizations:

    • Triple-threat users had 8.52x higher hospitalization odds (proxy for severe respiratory events) vs. non-users4.

    • Baclofen + opioids had 2.52x higher overdose risk than cyclobenzaprine + opioids in prescribed cohorts3.

4. Key Studies on Therapeutic-Dose Risks

  1. Human Experimental Trial:

    • Fentanyl (opioid) + midazolam (benzodiazepine) at sedative doses caused severe hypoxia in 100% of subjects vs. 50% with fentanyl alone8.

  2. Buprenorphine/Methadone Patients:

    • 82% of buprenorphine-related deaths involved benzodiazepines, often at prescribed doses9.

  3. Postoperative Mortality:

    • Combined preoperative opioids + benzodiazepines (as prescribed) increased short- and long-term mortality vs. either drug alone7.

Conclusion

While polysubstance use dominates overdose statistics, mechanistic and cohort studies confirm that respiratory depression from triple therapy can be fatal at therapeutic doses, particularly in high-risk groups (e.g., sleep apnea patients, elderly). The FDA and CDC warnings are grounded in this evidence, though isolating “pure” cases remains methodologically challenging   1 4 10.

Citations:

  1. https://www.fda.gov/media/99761/download
  2. https://pharmacy.ufl.edu/2020/07/06/uf-study-finds-some-combinations-of-opioids-and-muscle-relaxants-are-safe-others-raise-overdose-risk/
  3. https://pubmed.ncbi.nlm.nih.gov/35835561/
  4. https://pmc.ncbi.nlm.nih.gov/articles/PMC7502868/
  5. https://pmc.ncbi.nlm.nih.gov/articles/PMC7726637/
  6. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2773826
  7. https://apm.amegroups.org/article/view/35734/html
  8. https://cdn.amegroups.cn/journals/amepc/files/journals/8/articles/35734/public/35734-PB10-9925-R3.pdf?filename=apm-09-02-542.pdf&t=1722012648
  9. https://health.baltimorecity.gov/sites/default/files/Final%20Draft%20FDA%20petition-Full%20Co-Signers-2.19.16%20(2)%20(1).pdf
  10. https://onlinelibrary.wiley.com/doi/10.1111/bcpt.12655
  11. https://www.neurology.org/doi/10.1212/WNL.0000000000200904
  12. https://nida.nih.gov/research-topics/opioids/benzodiazepines-opioids
  13. https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm
  14. https://www.sciencedirect.com/science/article/pii/S0955395922003498
  15. https://jamanetwork.com/journals/jama-health-forum/fullarticle/2796898
  16. https://pubmed.ncbi.nlm.nih.gov/32022906/
  17. https://ufhealth.org/news/2020/uf-study-finds-some-combinations-opioids-and-muscle-relaxants-are-safe-others-raise
  18. https://pmc.ncbi.nlm.nih.gov/articles/PMC3454351/
  19. https://www.cdc.gov/overdose-prevention/about/prescription-opioids.html
  20. https://www.sciencedirect.com/science/article/abs/pii/S0376871619304703
  21. https://www.tandfonline.com/doi/full/10.1080/24740527.2020.1714431
  22. https://pmc.ncbi.nlm.nih.gov/articles/PMC5939871/
  23. https://academic.oup.com/painmedicine/article/19/1/79/3611356
  24. https://academic.oup.com/painmedicine/article/16/8/1566/2460700
  25. https://www.sciencedirect.com/science/article/abs/pii/S0379073821001390
  26. https://labeling.pfizer.com/ShowLabeling.aspx?id=4503
  27. https://dsps.wi.gov/Documents/BoardCouncils/MED/MEBGuideline.pdf
  28. https://www.hysinglaer.com
  29. https://academic.oup.com/painmedicine/article-pdf/19/1/79/24350605/pnx038.pdf
  30. https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm
  31. https://www.nmhealth.org/publication/view/guide/6327/
  32. https://www.aafp.org/pubs/afp/issues/2016/0615/p982.html
  33. https://www.oxycontin.com
  34. https://www.dol.gov/sites/dolgov/files/owcp/dfec/opioidactionplan/FullPaper-PatternsofChronicHigher-DoseandLower-DoseOpioidUseinFederalWorkersCompensationClaimants.pdf
  35. https://academic.oup.com/painmedicine/article/15/11/1911/1835923
  36. https://oxycontin.com/report-adverse-reactions/
  37. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19011.pdf
  38. https://apm.amegroups.org/article/view/35734/html
  39. https://health.baltimorecity.gov/sites/default/files/Final%20Draft%20FDA%20petition-Full%20Co-Signers-2.19.16%20(2)%20(1).pdf
  40. https://onlinelibrary.wiley.com/doi/10.1111/bcpt.12655
  41. https://www.oxycontin.com/important-safety-information/

Answer from Perplexity: pplx.ai/share

Filed under: General Problems | 2 Comments »

Next Page »