Napoleon had his “Waterloo” … how long before the community has to deal with their “opiate desert ” ?

I apologize that this blog ended up being much longer than I had intended, but things evolved

My blog is now in its TENTH YEAR… I have seen advocates come and advocates go… I have seen untold number of people putting up petitions to help the community… untold number that have called, emailed, faxed, sent letters to their Fed and state representatives.  Some advocate groups believe that state laws that would protect prescribers and pts is the way to go.  While I am not an attorney, I have asked – how can a STATE LAW prevent a FEDERAL AGENCY (DEA) from coming into a state to prevent them from enforcing a FED LAW ?  I have yet to have anyone even attempt to provide me a answer… even a educated guess as to why it could work.

I have only worked as an employee about 6-7 post college, the rest I was self employed and when you are self employed, especially when you businesses deal with Medicare, Medicaid & insurance and all the bureaucracies that businesses have to deal with.  So I have been watching/dealing with various bureaucracies for over 4 decades.  I have never seen when some rules/law/regulations is opened to be revised … things tend to get WORSE…

My opinion of the CDC opiate dosing guidelines 2022,  this will be no different.  Those entities that looked at the 40 odd pages of the 2016 guidelines and found their favorite sentence, paragraph or page and claimed that they were observing the guidelines while ignoring all the carve outs for how those chronic pain pts would be entitled to appropriate pain management.

everyone in the community needs to fully understand that they are not alone, but likewise… no one person alone nor can any “small group” alone can change the path that the community is on.

The community is up against a army of Goliaths – most with either a badge or a law degree – and we have seen that they interpreted the 2016 guidelines in a way that allowed them to falsely accuse all too many practitioners of violating the CSA and fabricate a case against them and send them to jail for 20 yrs and confiscate all their assets and leave his/her family penniless and throw hundreds of chronic pain pts into cold turkey withdrawal.

There are already some rumors floating around that some prescribers are already implementing a 50 MME/day limit and the revised guidelines are still just in the comment period and there are also some rumors about many of the same people/entities involved in the 2016 guidelines are once again on board to finalize the 2022 guidelines.

Given this recent article that validated what many of us already suspected … that the MME system has no clinical studies behind it…  If the MME system is included in this new guideline, should we question and legally challenge the “expertise” and competency of those who finalize the 2022 guideline ?

The community needs to decide if they are going to remain in their segregate little “tribes”  and struggle to be recognized more than any other tribe or they can come together and put their $$$ together and hire a law firm to challenge that the MME system has no valid medical use.  Then law firms will probably start lining up to take on healthcare corporation who are harming chronic pain pts by using the MME system to limit or restrict the amount of pain management – including opiates – that a pt is “entitled to” …

https://www.acsh.org/news/2022/03/01/true-story-morphine-milligram-equivalents-mme-16154

The above link by  Chuck Dinerstein, MD, MBA traced back the “origins” of the “MME SYSTEM” …  It would seems that according to Dr Dinerstein’s  “genealogy research on the MME system “…  it is basically a “bastard”… there is no clinical studies (parents) of this “child” what everyone is using today is just a mishmash of opinions/observations of a untold number of so called medical professionals.

Any comments made by patients to the CDC proposed guidelines will most likely be DISMISSED as biased or anecdotal observation(s)…  in the “scientific community” … otherwise – WORTHLESS.

We know that it has been reported that the 2016 guidelines used many studies that were rated “3” or “4” – with “4” being CRAP… so it would appear now that the CDC used one set of criteria that had NO VALID STUDIES BEHIND IT. Who believe that most/many/all of those on the first committee did not know or should have known that there no validity behind the  “MME SYSTEM” ?

This was a comment today on my blog  today on one my recent blogs :  https://www.pharmaciststeve.com/statistically-chronic-pain-pts-dont-exist/

Ohhh i know the senators baldwin and johnson of wisconsin know we exist.About 3-4 years ago now,,i specifically ask senator baldwins to put a box on all death certificates ,”death due to forced physical pain from medical condition,”I was informed i was speaking to ,”Sarah,senator baldwins intern,but her communication from baldwin was,and i quote,,,”prove it,”Prove that person died from forced physical pain,,To her point,,I am sure they have and will continue to deny our right to have our deaths recorded honestly.They do not want it recorded how many they have willfully killed,from a treatable condtion.Now with our Vets hospital,ie,”Tomah V.A. being the poster boy for fake opiate addiction,,they will never let the truth be shown here or in America,,that they have killed,medically tortured,tortured to literal death 10,000s,,,,Soo we have to go outside of the U.S. to prove this and end this genocide,however,,w/Russia going nuts, i think our cause will be put on a back burner for now???

Is this an admission that they have the community running in circles like a dog chasing it’s tail ?    They have “their” FACTS, “their” TRUTHS,  “their” AGENDA and anything submitted that does not align with those … will be ignored, discounted or somehow buried.

We know that pts who have their meds cut/eliminated most/many/all will end up with hypertension, and even if doc gives the pt all four categories of anti hypertensive meds… little/nothing happens… because apparently the process that the pharma’s meds work on – is different that the processes under/untreated pain uses to raise BP.  The American Heart Assoc has for decades – maybe a century – has stated that uncontrolled BP is the “silent killer”…  it will also damage the eyes, the kidneys, if a stroke or heart attack doesn’t get the pt first… but those are all “natural causes” of death.   It is pretty much a sure bet, that anyone with under/untreated pain will end up with Addison’s disease… only the time  line from when their meds are cut and the time they are diagnosed.

I expect that the proposed 2022 guidelines will be accepted and published without a word changed, and with the figure of 50 MME’s in the text…the DEA, VA and all others in healthcare who will take liberties with the guidelines – as they did the last guidelines to find their favorite sentence, paragraph, page and instead of having 40 odds pages from the 2016 guidelines, they have 211 pages to wade thru.  If history repeats itself, all of the exceptions to allow pain pts to be properly treated in those guidelines will be ignored. After all, all those entities who ignored those treatment exceptions in the 2016 guidelines will have to do the same processes with the new guidelines – or admit that  they were wrong before and they will have to admit that they were previously wrong and put all their budgets and number of employees at risk of being reduced…  which in a bureaucracy is heresy.

If you are gathering info from pts to send to the AMA… the AMA is basically a “toothless paper tiger”, maybe a small double digits percentage of MD’s belong to the AMA…  The only reason that the AMA is financially viable is because they own the writes to the ICD medical billing system and everyone who does medical billing has to pay them a annual royalty to use them.  The state Medical licensing boards having licensed MD on the board, who have a DEA license are fully aware that the DEA can fabricate a case against just about any doctor and bankrupt them and throw them in jail for 20 yrs… they are not going to disagree with a medical license they want to yank.

IMO, it is time for the community to quit the infighting and put their dollars together and challenged the validity of the MME SYSTEM…  just think how many rules/laws/regulations/ policies & procedures that reference that as their basis. All the docs sitting in jail because the DEA claimed that they prescribed opiates without valid medical necessity – that could be appealed…

If the 2022 guidelines are used to create new daily MME limits… like was done with the 2016 guidelines…  In the first page of the proposed guidelines.. they stated something to the fact that they were using the same “high standards” they used in creating the 2016…  We know that is a lie…  and that reminds me of  Einstein’s definition of “insanity”…  If history repeats itself – the community within 2 yrs of the guidelines being accepted/published…. the community could end up meeting its WATERLOO !!!

Here is probably something most people making comments on the CDC proposed 2022 guidelines, didn’t see – because it was a “link” on the page where one has to put comments

According to the last line, on the first page where people are to submit comments,   the CDC could care less about how their new guidelines are going – or have – to impact individuals without “WELL SUPPORTED COMMENTS”   – to me that suggests CLINICAL STUDIES

Summary

  • Read and understand the regulatory document you are commenting on
  • Feel free to reach out to the agency with questions
  • Be concise but support your claims
  • Base your justification on sound reasoning, scientific evidence, and/or how you will be impacted
  • Address trade-offs and opposing views in your comment
  • There is no minimum or maximum length for an effective comment
  • The comment process is not a vote – one well supported comment is often more influential than a thousand form letters


					

				

The TV show THE RESIDENT – very important show tonight 03/08/2022

https://www.fox.com/the-resident/  

The show tonight (03/08/2022)  Season 5 Episode 15  “in for a penny”

Parts of this show is very interesting… there is a couple of small parts about the actions/functions of the State Medical Licensing board in dealing with a complaint on a surgeon and a pt complaint about failed back surgery.

Having been a licensed Pharmacist for 51 yrs, I am fairly familiar with how state healthcare licensing board function and I was sitting at my desk and I have a 43″ LCD TV in front of me on my desk with this show on..  working on another new post for the blog … and luckily I have a TIVO system – which I often have to go to a hit “replay the last 15 second”… because I will hear something and while the TV audio is playing in the background in my head and my brain – “kicks me” .. with  WHAT THE HELL DID THEY SAY ?

Upon replaying the segment of the show about a BIG BOARD ROOM TABLE with a dozen or so Medical Licensing Board members sitting around and they are in the process of ending  their meeting and the “new member” of the board… tried to call the board’s attention to a pt’s complaint of a failed back surgery – what was described as a medical mistake that the collective board apparently decided to take no actions on the pt’s complaints… justifying that no surgery is perfect, etc…etc…etc… and willing to totally dismiss the complaint.  Even though this particular surgeon had several pt complaints against this surgeon with the Medical Licensing Board and apparently all had been individually dismissed without action and the board did not look back at the pt complaint history against this surgeon with the board.

I suspect tomorrow that a lot of  board members of a large number of state Medical Licensing Board Members will be on the phone with each other, exchanging emails, having a “zoom meeting” discussing – WTH – this was put on PRIME TIME TV ?

There is two different segments in the program – first one is in the first half of the show and the second in the last half of the show, both are important to watch to get the idea of the full concept.

There was also a sub-plot in the show about hospital systems that were preforming unnecessary procedures on Medicare/Medicaid pts solely to generate more revenue for the hospital system, I am sure that similar cases can be made against chain pharmacies – think “twisting arms” of chronic pain pts to purchase Narcan when they get their opiate Rxs filled.  Especially those pts who have been on opiates for years – never a OD issue – and lives alone and from a practical standpoint, who is going to administer the Narcan in the rare incident that the pt would accidentally OD  ?

This show should be taken to heart by pts to understand that our healthcare system and the healthcare licensing boards are not friends of pts, nor really not advocates for pts.

 

Pandemic Misinformation is Epidemic Misinformation

Pandemic Misinformation is Epidemic Misinformation

https://www.daily-remedy.com/pandemic-misinformation-is-epidemic-misinformation/

In the hallowed halls of the Supreme Court, a physician, Dr. Xiulu Ruan, sat as Justices mulled over the validity of his conviction for prescribing opioids illegally. In that moment, he was more than a physician. He was a symbol, not of the opioid epidemic, but of misinformation in general.

The same misinformation that appeared during the pandemic, that was always apparent in the opioid epidemic. That day, it bore out for all to see, as Justices grappled with the issue of criminal intent as it pertains to prescribing opioids. In trying to understand it, the Justices used analogies, inadvertently simplifying it. And in the process of simplifying a poorly understood healthcare concept, they gave rise to misinformation.

“How is that different”, Chief Justice John Roberts asked when drawing an analogy of prescribing opioids outside of the boundaries of established clinical care, absent any good faith, with driving a car beyond the speed limit. Well, it is plenty different.

For starters, driving a car beyond the speed limit is a conscious act to violate a law – the speedometer is right in front of you – and you know when you are going too fast. Claiming that a physician prescribed opioids illegally requires two points of interpretation across a sequence of clinical decisions and actions – the first is when a physician interprets the clinical need to prescribe pain medications and the second is when federal law enforcement interprets the physician’s interpretation.

The difference is precisely the matter at hand – hence the need to evaluate the exact parameters around which a physician who acted in good faith may be charged with a crime. But in trying to understand the case, Justice Roberts introduced an analogy that has garnered media attention and news bites.

In the minds of those parsing the case through articles written in media outlets, they will see an analogy of opioid prescribing and speed limits. They will correlate speed limits with opioid prescribing rates. And they will associate overprescribing with illegal prescribing. It does not take much to see how leaps in logic create convenient narratives.

How the Justices conveyed their arguments that day is no different from how the public understands the pandemic. We all crave simple narratives. They are how we understand healthcare. But we are telling wrong stories. And in telling the wrong ones, we give rise to misinformation.

We think healthcare is built on data and facts, that each data point guides clinical decision-making, and therefore patient outcomes. In reality, healthcare is built on perceptions and stories, as each experience is a plot point in the continuum of healthcare, and consequently our individual health.

Many remain vaccine hesitant because of the narrative that the vaccines were developed too soon or that an assortment of shadowy public figures holds some ulterior motive. There are no data supporting any of this, it is simply the perceptions held through the stories conveyed. And what we believe to be true determines the clinical decisions we make.

This applies as much to health policy as to individual decisions. The revised opioid prescribing guidelines by the CDC suggests as much. In page after page they caution against misuse of the guidelines and adamantly state that the worst interpretations taken from the original guidelines are not appropriate.

But instead of supporting an attempt by the CDC to improve upon guidelines that have caused so much harm to so many, multiple states came out in vociferous opposition to the revisions, to the point of defiance. For many state policy makers, the CDC revisions are taken as an assault on Federalism, not as an effort to improve patient care.

“The old language was a real problem,” Dr. Bobby Mukkamala of the AMA said. “When it got down to states and individual insurers and health systems it became dogma, it became gospel. It really left patients in a bad position.”

The guidelines need to be revised. We all agree on that much. But the perceptions through which policy makers see the revisions determine how they respond. They focus less on the language being revised, and more on the fact that the revisions may affect their current approach to opioids.

Through these reactions – not in response to the clinical language, but in implementing them legally – we see leaps in logic that have created a narrative around state rights, instead of quality of care for patients.

This makes the discourse during the oral arguments in the hearing of Ruan v. United States all the more concerning. By the choice of words used among the Justices, the oral arguments appear to have been nothing more than storytelling masquerading as a legal proceeding. And the ill-conceived talking points merely perpetuated misconceptions around the use of opioids that have long defined public misinformation in the opioid epidemic.

We can only hope the ruling is far better formulated than what the oral arguments would suggest. The fate of many patients and physicians depends on it.

Only in a GREAT AMERICAN CHAIN PHARMACY – can things like this happen

Currently in a dispute with my district manager (who is a licensed pharmacist) at a chain because they called me in the middle of my shift and told me I wasn’t filling scripts fast enough. I responded by stating that I was doing my best, that I felt this was inappropriate behavior from one licensed pharmacist with managerial authority over another, hung up the phone, blocked their phone number, and continued my shift. Thoughts?

Click here to find a independent pharmacy by zip code

to me – as a licensed pharmacists – that anytime that I see something like this from a chain pharmacist – and I know that it happens more times that it gets divulged anywhere – but – such incidents are seeing the light of day, than ever before.  Every time that I see similar statements from pharmacists, this video comes to mind

I have been around long enough that I saw the movie BEN HUR – when it was FIRST RUN.

I wish I could share all the comments from other pharmacists on this web posting… out of the 17 comments ONLY ONE thought that the pharmacist was I don’t think it was justified for you to hang up on them.  Keep in mind that the DM called the pharmacist on their PERSONAL CELL PHONE.  I have heard of pharmacists – under such situations – have locked the pharmacy down and walked out. How many of you have found the chain pharmacy, that you typically patronize, to have the Rx dept closed – at hours it is suppose to be open ?

But the next graduation class of some 14,000+ freshly minted PharmD’s in the next couple of months… many with six figure student loans that will have loan payments starting in 6-9 months and with all the pharmacists that have walked off recently – some of the chains are dangling up to a $50,000 sign on bonus for signing a three year work contract – what they don’t know – that has been shared by other Pharmacists that have signed those work contracts have stated…  if the pharmacist leaves even one day BEFORE THE CONTRACT IS FULFILLED – the entire sign on bonus will have to be REPAID IN FULL. 

What 60 million of your tax dollars buys for ADDICTS

I wonder if HUNTER BIDEN was a PAID CONSULTANT as to what was needed to be put into these “ADDICT CARE PACKAGES “?

Freedom Med CEO Kevin Jenkins: We Are Creating Freedom Med To ‘Break Away From Tyrannical Medical System,’ ‘Build A New World Where Healthcare And Human Life Are Valued’

Freedom Med CEO Kevin Jenkins: We Are Creating Freedom Med To ‘Break Away From Tyrannical Medical System,’ ‘Build A New World Where Healthcare And Human Life Are Valued’

https://www.thegatewaypundit.com/2022/03/freedom-med-ceo-kevin-jenkins-creating-freedom-med-break-away-tyrannical-medical-system-build-new-world-healthcare-human-life-valued/

The vast majority of COVID-19 related deaths occur in hospitals. But they’re not dying from the disease.

Numerous doctors warn that hospitals across the United States have been adhering to dangerous CDC protocols throughout the pandemic that coerce health practitioners to essentially murder COVID 19-infected patients.

In addition to insisting patients get dangerous experimental Covid 19 vaccinations, doctors are reportedly providing hospitalized COVID 19 patients Remdesivir, a drug that causes renal failure and pulmonary edema and then putting them on mechanical ventilators, a procedure that typically results in death.

Now, Americans who no longer trust the medical establishment have a new option.

Freedom Med launched this week, a telemedicine company that is “uniting medical professionals to protect your constitutional medical rights and enable you to take back your health” (signing up through this link and the links below benefits Gateway Pundit).

“Freedom Med is a new health care company that is going to be focused on changing the health in the country,” Freedom Med CEO Kevin Jenkins told the Gateway Pundit in an exclusive interview. “Freedom Med is going to give us the opportunity to select some of the greatest doctors on this planet and give opportunities to people all over the country to be able to get the proper care. They will not be turned away. It will be singularly focused on changing the culture of health in this country.

“I know something about medical racism, about medical apartheid and it’s a sad day in this country when these companies when our government is financing them to commit homicide on American citizens,” he said. “This is not the first time we have gone through this in this country. If you go back and research the 1800s we were going through the same thing, compulsory vaccines. This is why we are creating FreedomMed, so we can break away from this medical tyranny, so we can build a new world where healthcare and human life will be valued. This is about bringing more value, more transparency to the doctor, patient relationship.

While doctors across the country break their Hippocratic oath, denying life-saving treatment to critically ill patients, the team of medical experts with Freedom Med are “going to break that cycle, building trust, building transparency, building a relationship with your patient, getting the patient to understand that we value life,” Jenkins explained.

We value their health. It’s important that people start to understand that we can break away with this tyrannical system, that we can build something new. We can create solutions. We can create opportunities for people to build a better healthy life. Right now in America, we are some of the sickest people in the world.

We are going to be bringing transparency. We are going to be bringing amazing doctors to the table that cover all of the disciplines and medicines that we think are important to build a healthy community. Freedom Med is where it’s going to happen. You’ve got to follow us because If you join us at FreedomMed.org, you are going to see where we are going with this — top-notch doctors, top-notch healthcare, people that are coming up with solutions, people that value human life, people that value children. It’s time for us to break away from this system.

Expert immunologist Dr. Vladmire Zelenko announced on Friday that he has partnered with Freedom Med to institute “a brand new concept in health care.”

Zelenko, an early advocate for the use of hydroxychloroquine and a Nobel Peace Prize nominee, is calling on medical practitioners who have been penalized, suspended or criminalized and risked loosing their careers during the pandemic for providing effective treatments to patients despite hospital protocols to join the team at Freedom Med:

“We are recruiting doctors for a telemedicine national service. The doctors we want to recruit are those that believe that each human being is made in the image of God and that their lives have sanctity and that the needs of the patient must always come first. The last two years have shown us the exact opposite. The majority of the medical profession has sacrificed their patients to their own fears, bureaucracy, lack of innovation, lack of thought. Basically, most doctors follow directions and are just following orders and did what they knew was wrong. They let patients go home with no treatment and develop consequences and complications and lung damage and blood clots.

As we know now in retrospect, we could have prevented 85 percent of hospitalizations and deaths if we treated people in the right time frame. Those doctors that did try to do that were fired — mid-level providers, physician assistants, nurse practitioners,  clerical staff — anyone who dare advocate for keeping people alive was penalized, sanctioned, brought before medical boards —  those are the doctors I want. Those are the people, mid-level providers, nursing staff, medical assistants, clerical staff, secretaries — those are the people I want, who care for myself, my family, my patients. That’s what Freedom Med is about. There is a tremendous amount of talent out there due to the outright abuse by the medical profession of these wonderful people. The good thing is now we know who the doctors are. We know who the decent human beings are. We are going to revolutionize the standard of care.

Statistically chronic pain pts DON’T EXIST !

I was listening to Rep Pelosi & Senator Warren being asked questions today by reporters in regards to 650 million barrels of Russ crude oil that the USA purchases every day and both were asked “should we stop buying crude oil from Russia ?”  and both made similar statements – our economy will be just fine without the Russian crude oil.  That answer, totally out of context, seems rather benign.

Of course Pelosi’s net worth is estimated at 120 million and Warren’s net worth estimated at a measly 12 million. The crude oil that we purchase from Russia amounts to high single digits of the oil that the USA uses every day.  So all those families that can afford to pay $5-$6-$7/gal for fuel and be able to cut their oil consumption by upwards of 10% –  will be just fine.  Which I am sure that includes Pelosi & Warren.

It has been recently reported that 62.5% of USA families are living PAYCHECK TO PAYCHECK… even some families making $100,000/yr and the average household income is in the 60K-70K range.

We have all heard “horror stories” about how the CDC tracks “some death numbers”… every year they publish deaths from the FLU… but they only ESTIMATE those deaths. There has been reports that the CDC when dealing with OD’s, that they count “as a death” each substance that shows up in toxicology – and it is claimed that the typical OD toxicology report will show 4 to 7 different substances…. so can ONE OD … be counted as up to 7 different OD deaths ?

Why did I title this post as  – Statistically chronic pain pts DON’T EXIST ! – ..  If a pt has their pain meds reduced or eliminated … and ends up with blood pressure in the “stroke territory” and the pt dies from a stroke or heart attack – their death certificate will state stroke/heart attack… NOT … consequences of under/untreated pain.

Unless, the pt’s toxicology shows some opiates in it.. even a minor amount – and then most likely the death will be classified as “opiate related death” or “opiate use disorder death”

Even if the pt chooses their “final option” to end their tortuously level of pain…  if their death is a “mechanically cause suicide ” … their death is just a self-inflicted suicide or if they used their meds as their final option…  death will be determined to be a “opiate OD”.

I am sure that everyone has heard someone make the statement ” pain never killed anyone” and apparently the CDC death numbers just backup that misconception.

 

 

Was/is the CDC 2016 guidelines built on a “false foundation ” and created a covert genocide on a protect class of people ?

Over the last few weeks/months, I have been blogging about what is the science behind MME’s. Our DNA was not discovered until 1953 and was not completely “mapped” until 2003 and the CYP-450 liver enzyme system was identified in 1963, but there is some 50 odd separate and distinct enzymes in the entire CYP-450 system.

According to this article by Dr Dinerstein, the “MME System” seems to have evolved in a very haphazard manner.  Much like the game that many kids play, some shares a story and the story is passed from friend to friend and by the time that the store gets back to the person that started it … the story has probably CHANGED dramatically.

There has been a number of “players” with a anti-opiate agenda. Physicians for Responsible Opioid Prescribing (PROP) and some of its members seem to be a driving forced behind the CDC 2016 opiate dosing guidelines being published.  One has to suspect who was actually behind these guidelines. The CDC did not publish the proposed guidelines,  did not allow for a public comment period and tried to keep all those participating on the committee behind these guidelines remained ANONYMOUS. Their attempt to keep the members of the committee anonymous FAILED…and it became clear that many on the committee had a anti-opiate agenda.  In hind sight, it would appear that the Veterans Admin and the DEA pounced on these guidelines “before the ink had dried on the paper it was printed”

Since 2016, it appears to me that the DEA has moved from looking from “dead bodies” that could be attached to a prescriber’s practice to file charges, to finding someone in a practice’s pt base that are good con artist and is a addict or diverter..  they can be easily identified by data mining various state’s PDMP… then promising the “bogus pt” a “get our of jail free” card for promising to testifying specifics that DEA tells them against the prescriber…

Lately, the DEA is going after prescribers for violating some (non defined) standard of care and best practices… and thus providing controlled substances without a valid medical necessity, which – according to the DEA – makes the prescriber in violation of the Controlled Substance Act.

I have recently checked numerous FDA approved literature for the prescribing of the medication.  I did word searches for “MME” and there is NO REFERENCE to MME for all of these opiates. So, does that mean that the FDA DOES NOT RECOGNIZE the “MME system” ?  Why is it that the FEDERAL DRUG ADMINISTRATION does not recommend a reference to MME… they only recommend doses in MGS/micrograms.  There is published LD50 on meds – that is the mgs given to a number of pts… that 50% will DIE…   the problem with opiates is that LD50 will increase with opiate tolerant pts who have taken opiates over a longer period of time and/or taken high doses over a long period of time.

When the FDA approves a new medication, there is a recommended range of mgs and frequency of dosing and a specific disease state that the clinical trials have shown to help manage.  Physicians are free to use the medication “off-label” both for indication and dose range. The prescriber is assuming the risk – of harm to a pt – for giving a med for diseases not indicated for and/or doses above what the FDA/Pharma considers a “safe dose”… 

You don’t see the FDA going after prescribers for prescribing meds/doses “off-label”… that is what law firms are for … if a pt is harmed.


And this is just the first “dent in the DEA’s war on drug armor” that showed up this week… 

Here is what could be the second “dent in their armor”  The Curious Case of Dr. Xiulu Ruan

Most would consider the answer a straightforward no and the case simple enough to not require the high court’s time. But the opioid epidemic is anything but straightforward or simple. And the ensuing implications of a ruling in favor of Dr. Ruan will reverberate far beyond the original intent of the question – through the entire opioid epidemic and all the layers of policy and laws designed to curtail opioid abuse.

The question, like most things at the intersection of healthcare and law, appears simple enough, but is insidiously complicated. Good faith, as it is defined in the Controlled Substance Act, the law used to indict and convict Dr. Ruan, is a poorly constructed term, defined through vague, clinically irrelevant wording.

It is precisely through these ambiguities that the term good faith has been manipulated to represent anything but its original intent. Now it is understood through a legal interpretation of clinical behavior, defined by federal prosecutors who presume that by reducing opioid prescriptions, we will reduce the number of opioid related mortality.

But in heeding such misguided notions, federal prosecutors have similarly misinterpreted the definition of good faith, to one that is outside of its medically appropriate meaning. Good faith is not just a characterization of a singular action, but of one clinical action relative to another, to be examined within a broader context of patient care.

To understand this, we must begin where most physicians start their careers – by pledging an oath to patients. Most nascent physicians swear upon either the Hippocratic Oath or the Oath of Maimonides. In the latter, there is a distinct line that encapsulates a requirement for all physicians:

“May I never see in the patient anything but a fellow creature in pain.”

It implies that a physician by nature must implicitly trust patients unless proven otherwise. But trust cannot be afforded blindly; it must be balanced with oversight. Good faith is defined through the series of clinical actions within the context of a patient encounter that forms this balance.

For example, although access to care must be the default course of action for any physician, that access must be balanced with oversight, whether that is urine drug screens, imaging studies, or a review of a patient’s prescription history.

Law enforcement, not versed in pain management or addiction medicine, simply views the prescribing of opioids as a drug deal exchange. This is why prosecutors focused less on clinical decision-making and more on specific acts, or purported red flags, that inductively insinuate a physician behaved in a criminal manner with criminal intent.

Clinically, it has been proven that access to care improves quality of care. Instead of simply cutting off patients from medically necessary medications and incurring patient harm in the process, healthcare providers must continue to provide access to patient care while addressing the risks of abuse.

Access to healthcare is the essence of healthcare. The very concept of emergency care ensures access to care for all patients at all hours. Should every patient who presents to the emergency room with pain be denied medications unless they have legal verification to justify a prescription for opioids?

When we clarify the definition of good faith, we are actually clarifying the balance between access to care with its oversight – which translates into the courts as a comparative analysis of two legal interpretations – that of good faith with mens rea.

Mens rea is, true to topic, also a complex concept and derived from common law. It requires that the accused demonstrate criminal intent in order to be convicted of a particular crime, which modern courts have distilled into four component classifications.

 

  • 1. Acting purposely – the defendant had an underlying conscious object to act
  • 2. Acting knowingly – the defendant is practically certain that the conduct will cause a particular result
  • 3. Acting recklessly – the defendant consciously disregarded a substantial and unjustified risk
  • 4. Acting negligently – the defendant was not aware of the risk, but should have been aware of the risk

This may the point in the 52 yr war on drugs/pts for the community to put their dollars together to start by challenging the CDC, if they have/had the statutory authority to even generate those 2016 opiate dosing guidelines ?  Challenge the “MME system” itself as to being established without any valid science behind it. It was reported that the 2016 guidelines were established using studies that were mostly rated “3” or “4” as to the quality of data and conclusions… where “1” is good/excellent and “3-4” is poor/crappy”…  If one reads the new 211 page 2022 proposed CDC opiate dosing guidelines, they state in there that they are using the same “quality standards” that was used on the 2016 guidelines..  There is only 5 authors on the 2022 version and one hold over from the original committee  Dr Chou and if you look at the 20 pages of references… ONE WHOLE PAGE …lists reference where Dr Chou was one of the authors on all of those same references.

I believe that there are 37 states that have codified the CDC dosing guidelines at the state level.

I am seeing many references to Einstein’s definition of INSANITY…. with the proposed 2022 guidelines.

With so many entities finding their favorite sentence, paragraph, page out of the 40 odd pages of the 2016 guidelines and declaring that their policies and procedures are following the 2016 guidelines…  just imagine just how many new policies and procedures that could come out of 211 pages of the new proposed 2022 guidelines.

Just think of all the uncontrolled “snatch/grab” in many large cities where local District Attorney is refusing to prosecute any what use to be called “shoplifting” but now only those stealing more than $950 in Los Angeles & San Francisco to really be seen as a CRIME. I think that it was Walgreens has closed some 15-18 stores in bay area because of all the massive shoplifting.  Look at all the shooting/killings in big cities, because local District Attorneys are imposing no bail on criminals and putting them right back on the street in < 24 hrs… 

In 2021 our country averaged abt a COP SHOT/KILLED EVER DAY… abt 126% INCREASE OVER 2020 and yet ONLY ONE DEA AGENT was shot/killed in 2021 while trying to confiscate  money from someone on a cross country TRAIN.  https://abcnews.go.com/US/wireStory/shots-fired-amtrak-train-arizona-custody-80400081

According to the opinions of some of the Supreme Court Justices… in the above article, the DEA is/has criminalized the Controlled Substance Act… to justify their actions and justified their budget. While we have a TSUNAMI of illegal Fentanyl coming across our SW border.

NO ONE FEARS chronic pain pts…  prescribers, pharmacists/pharmacies – particularly chain pharmacies, hospital system, Insurance/PBM industry.  They do fear the DEA – because the DEA visits their HQ’s and threaten/intimidate them …. to fine them … often tens/hundreds of millions of dollars… for practicing medicine and treating chronic pain pts … in doses that the DEA have declared are “outside of -undefined – standard of care and best practices”.

These “badge carrying criminals” are causing people to be left to live/exist in a torturous level of pain, chronic pain pts are dying prematurely from under/untreated pain and committing suicide because they can no longer tolerate the torturous level of pain and see no alternatives to stop their torturous level of pain. What may be even worse is that there is no real accounting of the number of “dead bodies”.

Last night, President Biden’s state of the union https://www.ksdk.com/article/news/nation-world/joe-biden-state-of-the-union-text/507-3827f3f9-1884-487a-8802-99ac7ff48293 he stated

“First, beat the opioid epidemic. There is so much we can do. Increase funding for prevention, treatment, harm reduction, and recovery. Get rid of outdated rules that stop doctors from prescribing treatments. And stop the flow of illicit drugs by working with state and local law enforcement to go after traffickers.”

I don’t think that Biden was talking about getting rid of outdated laws that stop prescribers from prescribing meds for TREATMENT… that TREATMENT has nothing to do with treating PAIN.  Biden is an attorney, who was around when the Controlled Substance Act was signed into law and most likely his mindset is aligned with the DEA’s agenda that prescribed opiates directly leads to addiction, which leads to buying illegal opiates off the street and end up ODing/dying.

In the history of the 52 yr war on drugs/pts, it may be the first time that the facts supporting the war, may never been at its weakest level of supporting/justifying it existence going forward. If the community continues its history of infighting, continues its history of starting petitions, continues  its history of writing/calling your members of Congress, and continue its history of failing in putting their dollars together and hiring a law firm to challenge the validity of the CDC 2016 guidelines and all the studies and using the “MME system” that has no basis in medical science and the CDC, DEA, VA and other entities that knew or should have known that the CDC 2016 guidelines would create a covert genocide on a portion of our society that is a protected class under the Americans with Disabilities Law and Civil Rights Act from discrimination.

The True Story of Morphine Milligram Equivalents (MME)

https://www.acsh.org/news/2022/03/01/true-story-morphine-milligram-equivalents-mme-16154

By Chuck Dinerstein, MD, MBA — March 1, 2022

They are the foundation of the CDC’s 2016 opioid guidelines, resulting in legislation that limits opioid prescribing in 36 states. Morphine milligram equivalents, or MMEs, are used to set arbitrary prescribing limits for opioids by physicians, since many state legislators fail to understand – and translate into policy and law – the ‘16 guidelines. If we had all known the history of MMEs, perhaps we would not have been so eager to embrace them.

What exactly is a Morphine Milligram Equivalent (MME)? The CDC defines it as

“The amount of milligrams of morphine an opioid dose is equal to when prescribed. Calculating MME accounts for differences in opioid drug type and strength.” [emphasis added]

MMEs are used in pain management. Clinically, to help transition patients from an ineffective treatment choice to a more effective dosage, form, or medication. Researchers have also used MMEs in attempting to standardize data on medications and prescribing habits when using varying datasets.

The Source of MMEs – Not at all what you’d think

The origin of MMEs seems to be shrouded in the mists of history. The earliest reference to comparing one opioid to another was in a 1974 JAMA article treating the acute pain of myocardial infarction, “Meperidine hydrochloride in parenterally administered doses of 75 mg provides effective analgesia of the same duration as does 10 mg of morphine sulfate.” Two months later, that view of equivalence was rebutted as

“… counter to that of standard texts and journals of pharmacology and is not consistent with our own experience. While it is accepted that the meperidine dose equivalent to 10 mg of morphine is 75 to 100 mg, duration of analgesia by meperidine may be as little as 50% that of morphine. …in chronic or sustained pain, such as occurs in malignant invasion of bones or in sickle cell crisis, the difference is readily apparent to the alert physician and nurse. It has been suggested that physicians are undertreating patients in pain.” [emphasis added]

All the hallmarks of today’s concerns were there.

  • Clinical experience
  • Equianalgesic dosage (the amount to provide the same level and duration of pain relief)
  • The distinction between acute and chronic pain
  • Undertreatment of patients in pain

The next reference I found was published in 1984, coming from a study of 38 patients receiving opioids for chronic, non-malignant pain at Memorial Sloan Kettering’s pain clinic.

“A 25-year-old man developed severe left calf pain associated with swelling and tenderness. He was admitted to hospital in June 1975, taking approximately 28 morphine equivalent mg/24 h for pain.” [emphasis added]

There was no citation. The authors relied on their expertise or some unreferenced work to draw that equivalence.

A paper in the journal Pain from 1996 begins to unravel the underlying scientific studies performed in 1936.

“The morphine dose equivalents for hydromorphone and other opioids derive from single dose studies, all of which involved intramuscular or oral administration and measured pain reduction as the therapeutic endpoint.”

But the authors settle for an even more unsettling definition, based on a 1975 paper in the journal Anaesthesiology. The use of this paper to define MMEs is nothing short of astounding:

“Subjective responses to nurse-observer questions were used to quantitate analgesia for postoperative pain. Hydromorphone is more potent than commonly believed: approximately 0.9 to 1.2 mg is equianalgesic with 10 mg of morphine, with a similar incidence of side effects.”  [emphasis added]

It is scientifically illiterate to use this subjective casual observation to form the basis of policy. Yet, this paper is used as a reference by the CDC in its 2016 Opioid Prescribing Guide.

The CDC’s MMEs – Lost in Translation

The CDC explanation of their MME conversions references this paper, Defacto Long-term Opioid Therapy for Non-Cancer Pain, so let’s take a brief look at this study.

It looked at opioid use of adults in two healthcare plans, between 1997 to 2005, reflective of their regional demographics. There is exactly one sentence in the paper that you need to pay attention to:

“The conversion factors were based on information from multiple sources. After reviewing published conversion factors, consensus was reached among two physicians with clinical experience in pain management and a pharmacist pharmacoepidemiologist.” [emphasis added]

The basis of the CDC recommendations comes down to two physicians and a pharmacoepidemiologist. Not overwhelmingly “established” science. Let’s leave those subjective MME conversions to the side for a moment and consider the researchers’ quest to identify a “threshold” to long-term opioid therapy.

In their study, the overwhelming majority of patients took them for less than a month; 80% used opioids for less than a week, 14% took opioids, on average, for only a month. Only 5.5% of the patients receiving opioids took them for longer than a year; they became the focus. In searching for even longer-term use, a possible marker of “addiction,” the researchers found that half of those patients continued therapy into the next year – they were those most likely “to continue frequent use of opioids in future years.” [1] They identified a boundary or signal that an individual’s opioid use might be problematic.

“By setting a clear boundary between acute and episodic use on the one hand, and long-term use on the other, it may be possible for physicians and health plans to establish a check point ….”

There is no mention of MMEs. The variation in the amount of MMEs prescribed or taken among that 6% was too variable [2] to be a threshold; not surprising, given the subjective nature of their calculation. The researcher’s boundary line was the duration of prescribing – a year, the point that would identify that half of the 5.5% they felt to be “at risk.” Most importantly, their boundary was a call to reconsider therapy, not a limit on MME.

Other researchers with similar studies sought their bright line defining those at risk. But quietly, the risk changed from a concern over addiction, as a threshold based on length of treatment would suggest, to a concern over the risk of “overdose.” See the difference in the focus of a 2016 review which concluded

“A clear cut-point in opioid dosage to distinguish between overdose cases and controls was not found. However, lowering the recommended dosage threshold below the 100 MME used in many recent guidelines would affect proportionately few patients not at risk for overdose while potentially benefitting many of those at risk for overdose.”

Somewhere along the way, lost in translation, the concern of addiction morphed to concern over overdose. Despite a lack of “a clear cut-point in opioid dosage,” MMEs replaced fuzziness with pseudo-certainty.

If the ambiguity of what a threshold MME means is insufficient, MME suffers from two additional problems: its calculation and what is being measured. Topics we will address another day.

 

[1] This does not answer the question of whether their chronic pain had been adequately managed or whether some form of “addiction” or misuse was present.

[2] Among that 6%, there was a greater than 2-fold difference in prescribed amounts and a nearly 4-fold difference in amounts consumed.

 

The Curious Case of Dr. Xiulu Ruan

The Curious Case of Dr. Xiulu Ruan

https://www.daily-remedy.com/the-curious-case-of-dr-xiulu-ruan/

Dr. Xiulu Ruan has eight board certifications, a world record. He was the first physician trained as a Physiatrist who was recruited to be an Interventional Pain Fellow at the University of Michigan Health System. He ran a prolific private-practice focusing on pain management in Mobile, AL, serving nearly 8,000 patients.

He is now in federal prison, sentenced to 21 years for allegedly prescribing opioids illegally. Only there was no overt criminal act that landed him in his current lot. Rather, it was the absence of what non-clinically trained federal prosecutors believed to proper oversight. And when Dr. Ruan attempted to defend his actions as those performed in the best interests of patients, in good faith, the Eleventh Circuit federal court system – both district and circuit courts – denied the allowance of such a defense.

He now finds himself in front of the Supreme Court, the highest court in the land, arguing whether he should be allowed a defense that most would consider obvious – can a physician be criminally charged for clinical behavior performed in good faith?

Most would consider the answer a straightforward no and the case simple enough to not require the high court’s time. But the opioid epidemic is anything but straightforward or simple. And the ensuing implications of a ruling in favor of Dr. Ruan will reverberate far beyond the original intent of the question – through the entire opioid epidemic and all the layers of policy and laws designed to curtail opioid abuse.

The question, like most things at the intersection of healthcare and law, appears simple enough, but is insidiously complicated. Good faith, as it is defined in the Controlled Substance Act, the law used to indict and convict Dr. Ruan, is a poorly constructed term, defined through vague, clinically irrelevant wording.

It is precisely through these ambiguities that the term good faith has been manipulated to represent anything but its original intent. Now it is understood through a legal interpretation of clinical behavior, defined by federal prosecutors who presume that by reducing opioid prescriptions, we will reduce the number of opioid related mortality.

But in heeding such misguided notions, federal prosecutors have similarly misinterpreted the definition of good faith, to one that is outside of its medically appropriate meaning. Good faith is not just a characterization of a singular action, but of one clinical action relative to another, to be examined within a broader context of patient care.

To understand this, we must begin where most physicians start their careers – by pledging an oath to patients. Most nascent physicians swear upon either the Hippocratic Oath or the Oath of Maimonides. In the latter, there is a distinct line that encapsulates a requirement for all physicians:

“May I never see in the patient anything but a fellow creature in pain.”

It implies that a physician by nature must implicitly trust patients unless proven otherwise. But trust cannot be afforded blindly; it must be balanced with oversight. Good faith is defined through the series of clinical actions within the context of a patient encounter that forms this balance.

For example, although access to care must be the default course of action for any physician, that access must be balanced with oversight, whether that is urine drug screens, imaging studies, or a review of a patient’s prescription history.

Law enforcement, not versed in pain management or addiction medicine, simply views the prescribing of opioids as a drug deal exchange. This is why prosecutors focused less on clinical decision-making and more on specific acts, or purported red flags, that inductively insinuate a physician behaved in a criminal manner with criminal intent.

Clinically, it has been proven that access to care improves quality of care. Instead of simply cutting off patients from medically necessary medications and incurring patient harm in the process, healthcare providers must continue to provide access to patient care while addressing the risks of abuse.

Access to healthcare is the essence of healthcare. The very concept of emergency care ensures access to care for all patients at all hours. Should every patient who presents to the emergency room with pain be denied medications unless they have legal verification to justify a prescription for opioids?

When we clarify the definition of good faith, we are actually clarifying the balance between access to care with its oversight – which translates into the courts as a comparative analysis of two legal interpretations – that of good faith with mens rea.

Mens rea is, true to topic, also a complex concept and derived from common law. It requires that the accused demonstrate criminal intent in order to be convicted of a particular crime, which modern courts have distilled into four component classifications.

 

  • 1. Acting purposely – the defendant had an underlying conscious object to act
  • 2. Acting knowingly – the defendant is practically certain that the conduct will cause a particular result
  • 3. Acting recklessly – the defendant consciously disregarded a substantial and unjustified risk
  • 4. Acting negligently – the defendant was not aware of the risk, but should have been aware of the risk

 

When applied to most modern criminal cases, mens rea appears in one of two ways. The first is when a defendant commits an act knowing it is criminal in nature or has criminal consequences. The second is when a defendant does not commit an act, either knowing the lack of action will result in a criminal consequence or recklessly disregarding knowledge that he or she should have had.

Most healthcare crimes pertaining to the improper prescribing of opioid analgesics during the opioid epidemic are prosecuted the second way, where a prosecutor attempts to show that the lack of action, or the blatant disregard of oversight on the part of the physician, was criminal.

However, without the requisite clinical understanding, law enforcement often distorts or retroactively reinterprets particular actions or the absence of actions as criminal – because they do not balance access to care with oversight.

Effectively, when we conflate specific actions, or the lack thereof, as representative of clinical behaviors in its entirety, we are erroneously conflating isolated behaviors as representative of mens rea.

This is nothing more than conflating individual actions with broad definitions and misguided logic for healthcare experiences. Through such erroneous thinking, the potential risk of diversion has superseded the actual risk of poor clinical care.

Healthcare and law interact in its own balance, which balances the experience of healthcare with the logic of clinical decision-making, the primary clinical risks with the secondary and tertiary clinical consequences, and the quality of care with the socioeconomic constraints limiting it.

But among the many ways this complex balance can be viewed, we must recognize that the experience of healthcare is paramount – more specifically, the experience of those most vulnerable to misinterpretations or interpretive abuses of healthcare law.

And through this balance, we can clarify the definition of good faith – recognizing violations of good faith based on the relative balance of actions and behaviors perceived to be in good faith, relative to those perceived to arise out of mens rea.

Such a balance recognizes the difference between a medical error and a violation of personal liberty, differentiating between the two primarily through the patient experience.

But when law is subject to the whims of novel and medically inappropriate interpretations, the definition of good faith changes based on the interpretation presented. Over time these changes lead to ever weakening legal arguments. Eventually inductive logic and circular reasoning justify any crime. Soon even a well-intentioned medical error, transpiring over the course of clinical care, becomes a crime.

Yet healthcare needs error. In fact, medical errors are critical to healthcare, necessary for its advancement – errors form the basis of experimentation, which forms the basis of clinical research.

Instead of allowing healthcare to regulate itself, advancing through natural errors, the government has begun to regulate healthcare, which has changed the perception of medical errors. Errors are no longer seen as a natural part of healthcare but as willful acts of criminal transgression. Now instead of legal arguments based on medical data, we see subjective interpretations of clinical behavior absent the clinical context when describing medical errors.

All clinical care is founded upon the principle of good faith, which forms the essence of a trusting relationship between physicians and patients.  Any perceived violation of good faith must first balance good faith with mens rea by evaluating the totality of actions and decisions from the perspective of the patient experience. And then proceed to analyze the many attributes that form the complex balance of clinical decision-making and patient care – relative to one another.

If we think of healthcare and law as a balance, then the distinction between errors and crimes and the complex balance between good faith and mens rea becomes more discernible.

It is when we define healthcare behavior in absolute terms absent any clinical context that errors become crimes – creating contradictions between justice and freedom. As the French novelist Albert Camus wrote, “absolute justice is achieved by the suppression of all contradiction: therefore it destroys freedom.”

David Tauben, CDC Guidelines & how the National Pain Strategy Led to Patients Losing Opioid Access

https://youtu.be/OsX1pWZhPH8

There are “advocates” in the chronic pain community that are working so hard to make you believe t(hat the CDC Guidelines for Prescribing Opioids for Chronic Pain have nothing to do with the National Pain Strategy because they are working with Stanford to help implement the National Pain Strategy. Here is Dr. David Tauben (a member of PROP who is also at University of Washington) and you can hear the words from his own mouth telling those who are at this meeting that the NPS needed the guidelines. Those detractors who have worked so hard to destroy my reputation, call me a liar, say that I am wrong….you can’t deny video/audio. Here it is. The National Pain Strategy is a huge part of the reason that the chronic pain community of patients have lost access to opioid pain medication for their painful illnesses. It was not the CDC Guidelines. As I have said, “the CDC Guidelines is what happened to us”. Now, for all the supposed “advocates” who have worked so hard to hide this fact…they need to be held accountable and asked why. Why are they lying? Why are they hiding this truth from you? Fact of the matter is, they are not advocates for us, they are here to help implement the strategy, the very reason you lost access to your care. They are advocates for the people who have done this to you.