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

Image courtesy of qimono on Pixabay

Filed under: General Problems | 8 Comments »

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.”

Filed under: General Problems | 2 Comments »

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.

Filed under: General Problems | 8 Comments »

Filed under: General Problems | Leave a Comment »

This could be interesting, it is not clear if a FENCE has been put up around the capital or there is just talks of doing it. – Apparently Congress believes that fences can be important… of course, the White House already has a fence around it.  It will be interesting if Biden, Nancy & Chuckie use Canada’s PM Trudeau”s actions over the Truckers’ 3 week protest over mandatory vaccination – confiscating their trucks, confiscating their bank accounts and filing criminal charges against most/all involved. Even sending cops around to “talk to” anyone in the country who had contributed money to help the truckers. Apparently there are 10 Providences in Canada and FOUR have rescinded the vaccine mandates https://www.westernjournal.com/truckers-win-trudeau-loses-4-canadian-provinces-roll-back-covid-mandates-freedom-convoy/   What has yet to be seen, is this administration going to use Trudeau’s actions as a template as to how we respond to a similar protest?

The chronic pain community needs to pay attention, of all the protests over the last couple of years, as I remember, the largest showing was some 80 odd people…  Did any of those protests produce any positive change?

BREAKING: 38,000+ TRUCKERS HEADING TO DC FOR BIDEN’S SOTU ADDRESS

https://www.toddstarnes.com/national-news/breaking-38000-truckers-heading-to-dc-for-bidens-sotu-address/

A massive Freedom Convoy of truckers is heading from Los Angeles to the nation’s capital in time for President Biden’s State of the Union address on March 1, Breitbart reports.

Kyle Sefcik, the organizer of the Freedom Convoy USA 2022, said they want to send a message to the president.

“We want to be there for that and tell the president we’re here,” Sefcik told WUSA.

“This doesn’t even need to happen,” he added. “If the president said, ‘Mandates are over and the state of emergency is over. Let’s get back to the world and let’s do our thing,’ then we’re not even coming.”

So far, around 38,000 people have signed up fro the convoy.

And, despite authorities in Washington, D.C. putting a fence up around the Capitol, the organizer said they aren’t planning to go there.

“The United States Capitol Police and the United States Secret Service have been closely working together to plan for the upcoming State of the Union,” the Capitol Police said in a statement. “The temporary inner-perimeter fence is part of those ongoing discussions and remains an option, however at this time no decision has been made.”

Instead, he said trucks and motorcycles will head to the White House near the National Mall while Christian bands and pastors speak near the Washington Monument.

“We have to get the attention in the most peaceful way and this is our way of doing it,” Sefcik explained. “Do we want to stop businesses from being able to be open and people being able to get to work and school? No. We don’t want to cause this at all which is why we’re telling the president ahead of time to end this now. We don’t even have to come.”

Bob Bolus, a trucking company owner in Scranton, Pennsylvania, is also organizing a convoy headed to D.C.

“We will be along the Beltway where the Beltway will be shut down,” Bob Bolus told Fox 5 DC. “I’ll give you an analogy of that of a giant boa constrictor. That basically squeezes you, chokes you and it swallows you, and that’s what we’re going to do to D.C.”

He added, “There will be a lane open for emergency vehicles, they’ll be able to get in and out and all that. We will not compromise anybody’s safety or health, one way or the other. As far as if they can’t get to work, geez that’s too bad.”

Filed under: General Problems | Leave a Comment »

Note: This person works for one of the major chains.

Would you please post this anonymously? Thank you!

Some pharmacists from my company have been told to run the free Covid tests for separate rxs – example, if you are giving the patient 4 tests, you run 4 rxs for 1 test each instead of 1 rx for 4 tests.

Wouldn’t that be fraud? If there is a dispensing fee per rx, we would get 4 dispensing fees.

Anyone have any info on this?

Filed under: General Problems | Leave a Comment »

Fox News medical contributor slams agency for allegedly withholding COVID-19 data

https://www.foxnews.com/media/cdc-coronavirus-americans-medical-nicole-saphier

Fox News medical contributor Dr. Nicole Saphier told “America Reports” Tuesday a full investigation is needed into allegations the CDC withheld large portions of critical COVID-19 data from the public.

CDC DIRECTOR WALENSKY ON DROPPING COVID RESTRICTIONS: ‘WE’RE NOT QUITE THERE YET’

NICOLE SAPHIER: If you look across the globe, there is a reason why it is not so black and white in other countries because they’re looking at the big picture, especially when it comes to natural immunity — the true risk of COVID-19 in children, as well as boosters for young, healthy adults and children. Unfortunately, the CDC has done a disservice, in my opinion, to the American people. I think a full investigation should be launched into this, and at this point, we need to make sure that there is full transparency so that the private sector can accurately and adequately analyze the data, because the CDC is not a leader when it comes to public health.

Filed under: General Problems | 2 Comments »

As more and more evidence comes to light that the CDC is the keeper of TRUTHS and the spreader of LIES … Last night I made this post CDC: SOP of misrepresenting the facts that they publish/release    Notice that the FDA is pushing the two mRNA versions of the COVID-19 vaccine, J&J has stopped the production of their vaccine, but has millions of doses sitting on their shelves and could start production back up.  I find it curious as to why “they” are pushing the two mRNA versions of the vaccines… the mRNA process that is so NEW and so UNTESTED that if that had been the only option, I would have passed on getting a COVID-19 vaccination.  At least the J&J vaccine was produced using the same process that we have used for decades for making our flu vaccines.  The USA population has been involved in the LARGEST CLINICAL TRIAL with little/no control group and reportedly many/most/all of the serious adverse reactions – some of them lethal – have been not disclosed and/or buried.

Don’t forget all those who have claimed that those CLOTH MASKS do not work – like using a chain link fence to keep mosquitoes out… and yet many state/federal politician/bureaucrats mandate that masks be worn, even those over TWO YEARS OLD. If you notice, many states are now dropping mandatory masks because the mid-term primary will be starting next month. There will be more of our LIBERTIES that they will start GIVING BACK in the near term.

https://news.yahoo.com/u-fda-considers-approving-second-155455656.html

(Reuters) -U.S. health regulators are looking at authorizing a potential fourth dose of a COVID-19 vaccine in the fall, the Wall Street Journal reported on Saturday, citing sources familiar with the matter.

The Food and Drug Administration has been reviewing data to authorize a second booster dose of the messenger RNA vaccines from Pfizer Inc and partner BioNTech SE and vaccines from Moderna Inc, the report added.

The FDA did not immediately respond to a request for comment.

The agency last month cut the interval to get a booster dose of COVID-19 vaccines from Pfizer and BioNTech as well as from Moderna, in a bid to provide better protection sooner against the Omicron variant.

The planning is still in early stages, and authorization would depend on determinations as to whether the second booster should be authorized for all adults or particular age groups, and whether it should target the Omicron variant or be formulated differently, the report said.

It added that no decision was final and that it could be necessary to make booster shots available earlier if a new variant appears.

The United States reported 2,323 COVID-19 deaths on Friday, bringing the total count to 936,523.

Filed under: General Problems | 5 Comments »

The New York Times Makes A Stunning Admission About CDC Data On Vaccines

https://townhall.com/tipsheet/scottmorefield/2022/02/20/the-new-york-times-makes-a-stunning-admission-about-cdc-data-on-vaccines-n2603555

The New York Times made an eye-popping admission on Sunday regarding data collected by the Centers for Disease Control (CDC) on Covid-19 vaccines.

In an article titled, “The C.D.C. Isn’t Publishing Large Portions of the Covid Data It Collects,” reporter Apoorva Mandavilli writes: “For more than a year, the Centers for Disease Control and Prevention has collected data on hospitalizations for Covid-19 in the United States and broken it down by age, race and vaccination status. But it has not made most of the information public.”

Mandavilli, who covers science and global health for the Times, reported that the agency has published “only a tiny fraction of the data it has collected” since the pandemic began, including data on booster efficacy for 18 – 49 year-olds, a tremendous chunk of the U.S. population.

Reasons listed include bureaucracy, sample size, and not being “ready for prime time,” but one that’s definitely set to raise lots of eyebrows is the claim that the data could be “misinterpreted” by Covid vaccine skeptics. 

Filed under: General Problems | 1 Comment »

All the alphabetic federal entities that are coming after the chronic pain community…  Backin the mid-80s – thru mid90’s our community pharmacy did a fair number of opiate IV on end stage cancer pts at home.  What is now known as MME’s were around, but I don’t remember them being referred to a MME, but everyone knew that they were not workable – black & white conversions. Back then, there was no computer to calculate them for you…

‘back in the day” the rule of thumb rotating a pt from one opiate to another… was take the mgs using the opiate conversion answer and CUT IT IN HALF and then titrate the pts meds up or down to optimize their pain management..

The entire CDC guidelines and just about anything dealing with pain management is built on the FOUNDATION OF MME’s.

To the best of my knowledge, the MME’s were determined by naive people with mechanically induced pain (heat or cold) and given a SINGLE DOSE of a particular opiate.  This was before our DNA had been mapped and years before the liver CYP-450 was even “discovered” and no one could even believe to create a accurate MME’s without knowing the pt’s CYP-450 liver enzyme metabolism rate and those didn’t come around until the late 90’s or early 2000’s.

Here is one of those MME conversion program that use as a reference on occasion  https://globalrph.com/medcalcs/opioid-pain-management-converter-advanced/ and here are the footnotes on this same program:

1. 1. Published equianalgesic ratios are considered crude estimates at best and therefore it is imperative that careful consideration is given to individualizing the dose of the selected opioid. Dosage titration of the new opioid should be completed slowly and with frequent monitoring. 
   2. Conversion ratios in many equianalgesic dosing tables do not apply to repeated doses of opioids.
   3. The amount of residual drug in the patient’s system must be accounted for. Example: fentanyl will continue to be released from the skin 12 to 36 hours after removal of the patch. Residual effects from discontinued long-acting formulations should also be assessed before converting a patient to a new opioid.
   4. Review the concept of incomplete cross-tolerance: D. McAuley:   “Incomplete cross-tolerance relates to tolerance to a currently administered opiate that does not extend completely to other opioids. This will tend to lower the required dose of the second opioid. This incomplete cross-tolerance exists between all of the opioids and the estimated difference between any two opiates could vary widely. This points out the inherent dangers of using an equianalgesic table and the importance of viewing the tabulated data as approximations. Many experts recommend – depending on age and prior side effects – reducing the dose of the new opiate by 33 to 50 percent to account for this incomplete cross-tolerance. (Example: a patient is receiving 200mg of oral morphine daily (chronic dosing), however, because of side effects a switch is made to oral hydromorphone 25 – 35mg daily – (this represents a 33 to 50 percent reduction in dose compared to the calculated 50mg conversion dose produced via the equianalgesic calculator). This new regimen can then be re-titrated to patient response. In all cases, repeated comprehensive assessments of pain are necessary in order to successfully control the pain while minimizing side-effects.”

      5. The use of high but ineffective doses of a previous opioid may result in overestimation of the converted opioid. 

      6. Ideally, methadone conversions (especially patients who were previously receiving high doses of an opioid) should only be attempted in cooperation with a pain specialist or a specialist in palliative medicine. 

The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user’s use of or reliance upon this material.    PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  

I have tried to find some information about the person(s) or studies behind the MME’s concept, but have come up empty handed.  What would happen if the community could raise some money and challenge the CDC in court to produce the documentation of the studies behind the MME conversion ratios?  Might be able to get it with a simple FOIA ( Freedom of Information Act) request.

What would happen if the CDC could not produce a quality study to support the conversion ratios in all of opiates that they have used in the 2016 guidelines and the proposed 2022 guidelines. Could the validity of those very guidelines be put in jeopardy. Could the CDC be forced to rescind those guidelines..  Could that also mean that any other rules/regulations/policies and procedures would have to be made null & void.. until someone did a good quality study to develop workable MME conversions.

Could all those docs who have been put in prison for prescribing above a certain MME that the DEA considers above a certain limit and considers being without valid medical necessity be appealed and most likely overturned and they could be set free?

I am only posting this here on my blog, feel free to share….  just don’t try to share a hyperlink to anywhere on FAKE BOOK…  they have labeled my blog as a SPAMMER. 

Filed under: General Problems | 4 Comments »