Founding Fathers: Declaration of Independence: protect unalienable Rights: Life, Liberty and the pursuit of Happiness

Should a certain QUALITY OF LIFE (QOL) for every citizen in the USA be a SUBSET of “HAPPINESS” ? When our judicial system determines that a prescriber was not providing controlled substances in “good faith” to their pts and elects to raid and close a practice and throw hundreds of pts – “under the bus” and their QOL can be virtually TRASHED. Since most controlled substance Rxs are provided on a 30 days supply basis.. so pts within a raided practice, will start experiencing a cold turkey withdrawal within 1-2 days after the practiced was raided/closed and the total number of pts thrown into cold turkey withdrawal will increase daily for the next 30 days.  Those pts being prescribed both opiates and a benzo are at greater risk of their withdrawal being fatal.  Historically, no one in the DOJ/DEA or our entire judicial/law enforcement system is ever held responsible for any “collateral damage” to innocent pts within a medical practice that they raided/closed based on “legal opinion(s)” that is use to fabricate probable clause to proceed with charging a prescriber practicing medicine and prescribing medication(s) all in “good faith”. Is this all violations of the unalienable rights provided by our Declaration of Independence ? Is it a CONFLICT OF INTEREST that the bureaucratic entity that is suppose to protect these unalienable rights is the same bureaucratic entity that is violating the same. Is it also a violation of those in within those bureaucratic entities who took a oath to PROTECT AND DEFEND OUR CONSTITUTION ?

A Matter of Good Faith

https://daily-remedy.com/a-matter-of-good-faith/

The phase of the moon predicts the strength of the tide.

A fact known throughout history among sailors who planned seafaring voyages based on phases of the moon, knowing it to correspond with the ideal tide for setting sail. They may not have known what the sea would bring, but they used the moon as a guide. For them, it was a matter of faith.

So whenever the tides proved turbulent despite the ideal phases of the moon, sailors would not blame themselves. They know sailing is inherently dangerous and mistakes are inevitable. For them, mistakes made in good faith are a natural part of sailing.

Good faith is a term that is both instinctively understood yet difficult to define, precisely because it is a distinctly subjective term. We all understand its meaning, but we each understand it in slightly different ways. And the differences grow more pronounced as the behavior in question grows more complicated.

This is likely why the Supreme Court has agreed to weigh in on the issue of good faith in healthcare – a hopelessly complicated field defined by complex decisions and actions made in rapid succession. Good faith in healthcare is often a matter of opinion, which explains why it is interpreted so wildly in federal courts across the country – even for the most mundane of actions, like writing a prescription.

Such as in the case of Dr. Xiulu Ruan v. United States, an Alabama physician who was convicted of prescribing opioids, a controlled substance, outside the scope of medical practice. She argued that she acted in good faith, that the action perceived to be criminal, the writing of prescription opioids, was performed as a physician caring for her patients, in good faith.

However, the district judge in her case dismissed the argument, claiming it did not apply, preventing her from using a good faith argument as a defense. A ruling that was subsequently upheld upon appeal, and has now made its way to the Supreme Court for review. The question now presented to the Supreme Court is whether a physician alleged to have prescribed controlled substances outside the usual course of professional practice may be convicted despite acting in good faith.

For those in the healthcare profession, this may seem like an obvious question. But it is anything but obvious in the courts of law, where the interpretations of law determine how it is implemented in society – and consequently perceived in healthcare. Even minor changes in legal interpretation have the potential to reverberate loudly across healthcare, leading to material changes in clinical decision-making.

It is perhaps no coincidence then that the Supreme Court has taken upon itself to answer this question now, years after waves of opioid litigation and physician arrests have made headline news. And years after physicians have dramatically reduced the number of opioid prescriptions.

In fact it is obvious, the tide is turning.

The many high profile opioid litigation cases and ensuring rulings in recent years have not produced the intended effect of curbing opioid abuse and instead have unleashed a slew of unintended effects harming patient care.

In hindsight, these cases have proven mostly ineffective, at times disingenuous on the part of prosecutors, and exacerbated the opioid epidemic’s latest wave of fentanyl induced overdoses.

The interpretations of opioid related laws, whether they were cleverly concocted interpretations of public nuisance ordinances, or draconian interpretations of physician behavior, regardless of any good faith intentions, did not curb opioid abuse – it worsened it.

Something the public has long understood. And something the courts across the country are starting to realize. How laws are interpreted affect their implementation. And even minor changes in interpretations have outsized effects on clinical behavior.

In California and Oklahoma, each state’s respective higher courts have overturned high profile legal cases against opioid manufacturers and distributors that claimed these companies were liable for the opioid epidemic using public nuisance ordinances as the basis for the liability claim.

The original rulings were predicated upon curious interpretations of law – acknowledged to be novel even back then – but permitted under the pretense that public health policies can be addressed by moralizing medical behavior through the courts of law – a pretense that has proven flagrantly false, time and time again. And to the courts’ credit, they corrected erroneous interpretations of public nuisance laws.

But now an even more important legal interpretation finds its way to the highest court in the land – the interpretation of good faith, an interpretation that resides at the heart of the patient-physician relationship, and an interpretation that will reverberate into every patient room across the country.

Good faith is the term that, when the definition is met legally, permits a prescriber to dispense controlled substances to patients based on medical need, an act that is regulated by the Controlled Substance Act and enforced by the Drug Enforcement Agency.

Currently, the term is interpreted and executed through a series of vague definitions that attempt to ascribe a particular act or behavior that violates normal clinical behavior in which a controlled substance would be prescribed – as someone who is not medically trained would understand it.

Traditionally this would include exchanging the quantity of opioids for direct financial remuneration, for sexual favors, or absent any actual clinical engagement. Yet during the height of opioid criminalization, the term was redefined to include acts and behaviors normally seen in the patient encounter, but may construe substandard clinical care, as interpreted through a retrospective analysis of the patient encounter.

Soon, physicians were indicted depending on whether or not they ordered a urine drug screen or reviewed a prescriber database. The term good faith was reinterpreted to define the quality of care as it was understood by non-clinically trained law enforcement agents.

As a result, the fear of prosecution defined the quality of care for patients. Opioids were restricted. Patients with chronic pain or substance use dependency were abandoned by their physicians. And physician arrests made headline news.

Physicians could now be charged criminally for clinical behavior, or for a lack of presumed clinical oversight, all under the aegis of the term, should have known. Now the speculative fear of what the term, good faith, could or could not be interpreted to mean superseded actual medical need, or what the physician should have known.

Legal interpretations that are vague and defined upon speculative behavior are generally deemed to be unconstitutional. But in our misguided attempt to address the opioid epidemic through moralizations of healthcare law, we permitted unconstitutional interpretations of legal terms.

Now the Supreme Court has an opportunity to rectify this.

But we caution the Justices to be mindful of the exaggerated effects legal interpretations have in healthcare – recognizing that clinical behavior is often influenced by what the legal interpretations do not say, more than by what they actually say. In other words, the unintended effects or interpretations of vague legal definitions have an outsized influence on healthcare behavior.

In healthcare, we react to the uncertainty within a law, not to the law itself. And minor interpretative changes in law have unexpectedly outsized effects in healthcare, most noticeably in subtle healthcare behavior and decision-making.

In fact, the more subtle the impact of the healthcare law on clinical decision-making, the greater the impact of the uncertainty on healthcare behavior – and the greater the adverse effects of unintended consequences.

Accordingly, when the matter of good faith is presented to the Supreme Court, it becomes incumbent on the Justices to not only define the term with more clarity, but also understand how any proposed revision of the term may lead to unintended consequences or uncertainty in healthcare behavior – the second and third order consequences of legal interpretations in healthcare.

This is decidedly far more difficult than simply clarifying the term or recognizing the term cannot encroach into traditionally assumed clinical behavior. But the ramifications of defining the term in this manner will influence the way prosecutors target physician behavior, and the way physician behavior is interpreted in courts.

And most importantly, ensure that the interpretations of healthcare law protect physician rights, in much the same way laws emphasizing harm reduction protect patient rights.

Healthcare is a liberty, to be understood as an affirmative right, balancing social responsibility with individual actions. All legal interpretations must be derived through this understanding. We pray the Supreme Court recognizes this and uphold the principles of the Constitution during the deliberations.

It is a matter of good faith – not just for physicians, but for all of healthcare.

Major law firm confirms FDA deceived America with its ‘approval’ of Pfizer vax

Major law firm confirms FDA deceived America with its ‘approval’ of Pfizer vax

https://principia-scientific.com/major-law-firm-confirms-fda-deceived-america-with-its-approval-of-pfizer-vax/

When the U.S. Food and Drug Administration announced Aug. 23 it had granted full approval to the first Covid “vaccine” under the brand name Comirnaty, the mainstream media immediately ran with the narrative.

Joe Biden jumped in front of a microphone and told businesses they needed to “step up” the mandating of vaccines for their employees.

Dr. Anthony Fauci told national media outlets he expected a whole host of new “mandates” to be fueled by the “approval” of the Pfizer jab.

There’s only one problem. The “approval” given by the FDA was not for the Pfizer jab currently available in the U.S. market.

The devil is always in the details. Some of us weren’t fooled.

See our article, which has over the past three days received nearly 150,000 reads: FDA ‘playing bait and switch’ with Americans, tricking them into believing shots currently being offered have been granted full approval when they have not.

But because we and a few others looked beneath the facade and checked the facts of what the FDA actually did and not what the media and Joe Biden’s administration said it did, we took some heat. Even some of our own subscribers questioned whether maybe we got it wrong.

No, it was the corporate media who got the story wrong. And as a result, thousands of Americans no doubt capitulated and went ahead and rolled up theirs sleeves, thinking they had no other choice legally than to succumb to their employers’ mandates.

Today, on Aug. 27, the Orlando, Florida-based Liberty Counsel, perhaps the most respected Christian legal firm in the nation, issued a press release that confirms our story.

Below is the release, published in full from Liberty Counsel.

WASHINGTON, D.C. – The Food and Drug Administration (FDA) has done a bait and switch by announcing it approved its “first COVID-19 vaccine” in order to push the “vaccine” mandates and protect the Pfizer pharmaceutical company from legal liability. However, there is currently no fully licensed COVID shot on the United States market.

Albeit confusing, and probably intentionally so, this summarizes the current status of the Pfizer-BioNTech shots:

  1. All existing Pfizer vials (in the hundreds of millions), remain under the federal Emergency Use Authorization (EUA) (meaning people have the “option to accept or refuse”);
  2. The third or “booster” Pfizer shot is identical to the above and remains under the EUA with limited use to certain categories of people;
  3. BioNTech received FDA approval for people ages 16 and above under the name Comirnaty, but there are no Comirnaty doses available in the United States;
  4. In other words, there is currently NO FDA approved COVID-19 injection available anywhere in the United States. Every COVID shot in America remains under the EUA law and thus people have the “option to accept or refuse” them; and
  5. Even when an FDA approved COVID shot becomes available, individuals are protected by federal law and many states laws from being forced to get these shots based on their sincere religious beliefs or conscience rights.

On August 23, the FDA issued two separate letters for two separate injections. There are now two legally distinct (Pfizer vs. BioNTech), but otherwise identical products.

The first letter is regarding FDA’s biologics license application approval for the Pfizer Inc/BioNTech COVID-19 injection which has been named Comirnaty. Yet Pfizer has not started manufacturing or labeling this drug for U.S. distribution, so it is not even available in the U.S.

It is unclear whether or not it is protected by a liability shield, but web-based U.S. government communication indicates that the same program that provides compensation for COVID vaccine-related injuries will apply Countermeasures Injury Compensation Program (CICP) rather than the National Vaccine Injury Compensation Program).  At this point, there apparently has been no compensation paid to people injured by one of the COVID shots via the CICP.

The Pfizer injection, on the other hand, is still considered experimental under U.S. law. There is a legal difference between products approved under authorization of emergency use (EAU) compared with those the FDA has fully licensed. The FDA issued another letter for the existing Pfizer shots which confirms they are still under EUA, are not fully approved, and has a liability shield.

EUA-approved COVID shots have a liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability. People who have been injured can file a lawsuit if they can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.

That means people must be told the risks and benefits, and they have the right to decline a medication that is not fully licensed. The federal Emergency Use Authorization law and the FDA, including the FDA Fact Sheet, state unequivocally that each person has the “option to accept or refuse” the shots. In addition to federal law, the FDA includes the Nuremberg Code and the Helsinki Declaration on its website, emphasizing the fact that people cannot be forced to take experimental drugs without their full consent.

The FDA’s approval letter to Pfizer regarding the BioNTech injection, Comirnaty, states: “Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, which is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.”

This letter affirms the FDA has not approved the Pfizer/BioNTech injections for the 12- to 15-year age group, nor any booster doses for anyone.

Regarding the Comirnaty injection, the FDA admits, “We have determined that an analysis of spontaneous post marketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.”

Therefore, follow up studies will be required with children six months to 15 years as well as six studies for up to five years regarding the adverse effects of myocarditis and pericarditis.

In addition, the FDA bypassed and disregarded the normal advisory committee and public comment process for this license. 

The letter states, “We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion” (emphasis added).

The FDA also acknowledges that while Pfizer-BioNTech has “insufficient supplies” (in other words, it is not currently available on the U.S. market) of the newly licensed Comirnaty vaccine actually available. However, the letter also states there is “a significant amount” of the Pfizer-BioNTech shots which has been produced under the EUA and will continue to be offered under the same EUA status.

In its approval letter, the FDA specifies the Pfizer shot under the EUA should remain unlicensed, is still available for use, and can be used “interchangeably” with the newly licensed Comirnaty product. According to the FDA, the newly licensed Comirnaty injection and the existing Pfizer shot, while “legally distinct,” are not any different in terms of their “safety or effectiveness.”

Despite whether these COVID shots are licensed or not, they cannot be mandatory under Title VII. In general, employee vaccine religious exemption requests must be accommodated, where a reasonable accommodation exists without undue hardship to the employer, pursuant to Title VII of the Civil Rights Act of 1964. Many people hold sincere religious beliefs against taking the COVID shots or taking those derived from or which used at any stage of the development aborted fetal cell lines.

Title VII defines the protected category of religion to include “all aspects of religious observance and practice, as well as belief.” 42 U.S.C. § 2000e(j). Moreover, as the EEOC has made clear, Title VII’s protections also extend nonreligious beliefs if related to morality, ultimate ideas about life, purpose, and death.

See EEOC, Questions and Answers: Religious Discrimination in the Workplace (June 7, 2008), (“Title VII’s protections also extend to those who are discriminated against or need accommodation because they profess no religious beliefs…Religious beliefs include theistic beliefs, i.e. those that include a belief in God as well as non-theistic ‘moral or ethical beliefs as to what is right and wrong which are sincerely held with the strength of traditional religious views.’

Although courts generally resolve doubts about particular beliefs in favor of finding that they are religious, beliefs are not protected merely because they are strongly held. Rather, religion typically concerns ‘ultimate ideas’ about ‘life, purpose, and death’”).

Liberty Counsel Founder and Chairman Mat Staver said, “The FDA has apparently tried to deceive people by issuing its two confusing letters without proper explanation. Despite the FDA’s slight of hand, there is currently no FDA approved COVID shot available in the United States. Even if there were an FDA approved COVID shot available, people still may request that employers, schools, and the military accommodate their sincerely held religious beliefs.”

Another personal costs increase – as a result of the COVID-19 pandemic ?

I could not find the exact percentage of what goes into what a pt’s monthly Part B premium is, but as I remember … in 2022… the calculation goes back to 2020 and the total paid out by Medicare Part B is totaled and divided by the number of people covered under Part B… and in 2022… the feds pay 75% of that costs and pts pay the remaining 25%..  Of course in 2020 the COVID-19 epidemic started in the first couple of months of that year.  I have seen a number of people surviving having COVID-19 having medical cost is EXCESS of ONE MILLION DOLLARS.  I would suspect that the people on Medicare ( elderly & disabled ) were at more risk of being infected by the COVID-19 virus.

According to the charts in this post, Part B premiums will be 14.5% HIGHER in 2022.

Personally, our Part D premiums will increase 10% and our deductible will increase 8% in 2022.. that is after we went from a ZERO DEDUCTIBLE in 2020 to a $435 deductible in 2021 and will increase to $485 in 2022. Making the annual deductible MORE THAN the ANNUAL PREMIUMS for Part D.  I am sure that when our Medicare supplements come up for their annual renewal, we will see similar per-cent increase in those premiums..  I suspect by the time all is said and done… the increased cost in/around Medicare will pretty much consume the $$$ increases in our SS monthly payments.

This article https://headlinehealth.com/big-pharma-spikes-medicare-part-b-premiums/ states that a new med for Medicare officials told reporters on Friday that about half the increase is due to contingency planning if the program ultimately has to cover Aduhelm, the new $56,000-a-year medication for Alzheimer’s disease from pharmaceutical company Biogen. Aduhelm is the first Alzheimer’s medication in nearly 20 years. It doesn’t cure the life-sapping condition, but the Food and Drug Administration determined that its ability to reduce clumps of plaque in the brain is likely to slow dementia. However, many experts say that benefit has not been clearly demonstrated.

Add to this the cost of treating the dramatic rise in COVID-19 infections and the push of many pain clinics to put pts on spinal stimulators and implanted pumps… to avoid oversight of the DEA on opiates being prescribed to chronic pain pts…  When a pt being prescribed and taking opiates to treat their chronic pain … which is a much lower annual cost and therapeutically is as good – or better – than the higher cost alternatives being pushed on pts.

Maybe this will force Medicare folks to PUSH HARDER for bureaucrats to look into the “obscene profits” that are being generated by the PBM industry.  Here is a graphic that show just how much of the cost of medications at the Rx counter goes to these PBM MIDDLEMEN.. Who provides little more than an administrative service in the medication transactions between the pharma and the pt.

 

Part B costs

Some people automatically get 

, and some people need to sign up for Part B. Learn how and when you can sign up for Part B.

If you don’t sign up for Part B when you’re first eligible, you may have to pay a late enrollment penalty.

How much does Part B cost?

Part B premiums

You pay a premium each month for Part B. Your Part B premium will be automatically deducted from your benefit payment if you get benefits from one of these:

  • Social Security
  • Railroad Retirement Board
  • Office of Personnel Management

If you don’t get these benefit payments, you’ll get a bill. 

Most people will pay the standard premium amount. If your modified adjusted gross income is above a certain amount, you may pay an Income Related Monthly Adjustment Amount (IRMAA). Medicare uses the modified adjusted gross income reported on your IRS tax return from 2 years ago. This is the most recent tax return information provided to Social Security by the IRS. 

 

2021

The standard Part B premium amount in 2021 is $148.50. Most people pay the standard Part B premium amount. If your modified adjusted gross income as reported on your IRS tax return from 2 years ago is above a certain amount, you’ll pay the standard premium amount and an Income Related Monthly Adjustment Amount (IRMAA). IRMAA is an extra charge added to your premium.

If your yearly income in 2019 (for what you pay in 2021) was You pay each month (in 2021)
File individual tax return File joint tax return File married & separate tax return
$88,000 or less $176,000 or less $88,000 or less $148.50
above $88,000 up to $111,000 above $176,000 up to $222,000 Not applicable $207.90
above $111,000 up to $138,000 above $222,000 up to $276,000 Not applicable $297.00
above $138,000 up to $165,000 above $276,000 up to $330,000 Not applicable $386.10
above $165,000 and less than $500,000 above $330,000 and less than $750,000 above $88,000 and less than $412,000 $475.20
$500,000 or above $750,000 and above $412,000 and above $504.90

 

2022

The standard Part B premium amount in 2022 is $170.10. Most people pay the standard Part B premium amount. If your modified adjusted gross income as reported on your IRS tax return from 2 years ago is above a certain amount, you’ll pay the standard premium amount and an Income Related Monthly Adjustment Amount (IRMAA). IRMAA is an extra charge added to your premium.

If your yearly income in 2020 (for what you pay in 2022) was You pay each month (in 2021)
File individual tax return File joint tax return File married & separate tax return
$91,000 or less $182,000 or less $91,000 or less $170.10
above $91,000 up to $114,000 above $182,000 up to $228,000 Not applicable $238.10
above $114,000 up to $142,000 above $228,000 up to $284,000 Not applicable $340.20
above $142,000 up to $170,000 above $284,000 up to $340,000 Not applicable $442.30
above $170,000 and less than $500,000 above $340,000 and less than $750,000 above $91,000 and less than $409,000 $544.30
$500,000 or above $750,000 and above $409,000 and above $578.30

Part B deductible & coinsurance

In 2021, you pay $203 ($233 in 2022) for your Part B 

. After you meet your deductible for the year, you typically pay 20% of the 

 for these:

Find out what Part B covers.

Find out what you pay for Part B covered services.

 

Against The Pain: The Opioid Crisis And Medication Access

Against The Pain: The Opioid Crisis And Medication Access

Against The Pain: The Opioid Crisis And Medication Access

https://www.pharmaciststeve.com/what-every-patient-should-know-about-narxcare/

https://www.pharmaciststeve.com/magic-mushrooms-get-a-win-for-depression-in-early-trial-drugmaker-says/

The above link was a post that I made about the same time that Narxcare first came on the scene.. over THREE YEARS AGO. In this post, I commented that I did not think that the community would fare well under this system in the long term.

The graphic above is a link to a 1 hr+ audio from NPR from a couple of days ago. Looking in hindsight it would seem that the DEA’s classification of various substances in the list of controlled substance. Now appears to have been done with little SCIENTIFIC FACTS.

Initially MJ is a C-I at the federal level… illegal substances with no valid medical value – which now has been declared LEGAL in some 40 states & DC for a combination of uses from only medical necessary and some recreational use.

MAGIC MUSHROOM – was a C-I.. and now being used in a clinical trial to treat depression.

Kratom is a “relative” of the coffee tree and a illegal substance in some six states and the DEA is trying to get it scheduled as a C-I

Hydrocodone & Acetaminophen was originally classified as a C-III – but in 2014, the DEA decided that it needed to be classified as a C-II.. While all along Tylenol with Codeine remains a C-III and Codeine is metabolized in the body to MORPHINE – which is a C-II

The bottom line is that there is all too many people who draw a paycheck from the WAR ON DRUGS… at least 12,000 at the Federal level and a unknown number at the city/count/state level involved part or full time fighting the war on drugs. Plus all the prosecutors , defense attorneys, judges and the court/jail system.

Ronald Reagan once stated,  The closest thing to eternal life on earth is a Government Program

 

 

 

 

Expert panel on federal vaccine mandates

Sen Manchin: clearly he believes who is behind the “fabricated opiate crisis ” ?

Manchin opposes Biden FDA nominee, citing ties to ‘greed’ of pharmaceutical industry

https://www.foxnews.com/politics/manchin-opposes-biden-fda-nominee

Democratic Sen. Joe Manchin of West Virginia came out in opposition to President Biden’s nominee to lead the Food and Drug Administration (FDA) over the candidate’s ties to the pharmaceutical industry amid the opioid crisis.

Manchin released a statement on Friday opposing Biden’s FDA nominee, Robert Califf, who led the agency at the tail end of the Obama administration.

The moderate Democrat from West Virginia said that Califf’s nomination “makes no sense” amid the opioid epidemic still ravaging America and wreaking “havoc on families across this country with no end in sight.”

Sen. Joe Manchin, D-W.Va., delivers remarks to reporters at the U.S. Capitol in Washington, D.C., Nov. 1, 2021.

Sen. Joe Manchin, D-W.Va., delivers remarks to reporters at the U.S. Capitol in Washington, D.C., Nov. 1, 2021. (REUTERS/Jonathan Ernst)

BIDEN EXPECTED TO ANNOUNCE ROBERT CALIFF TO LEAD FDA, BRINGING BACK OBAMA-ERA OFFICIAL

The senator also blasted the nominee for his ties to the pharmaceutical industry, which has been credited by many with playing a major role in exacerbating the opioid epidemic.

“2020 was the deadliest year on record for drug related overdose deaths, with 1,386 and nearly 95,000 Americans dying from a drug-related overdose,” Manchin said. “I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic.”

“Instead, Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward,” the West Virginia Democrat continued. “His nomination is an insult to the many families and individuals who have had their lives changed forever as a result of addiction.”

Manchin said he “could not support” Califf’s nomination just as he was opposed to the former commissioner’s previous 2016 nomination and called on the Biden administration to put up a nominee “that understands the gravity of the prescription drug epidemic” as well as the FDA’s role “in fighting back against the greed of the pharmaceutical industry.”

“Championing the needs of our nation’s public health should be their No. 1 priority,” Manchin concluded.

Dr. Robert Califf awaits the start of his nomination hearing before the Senate Health, Education, Labor and Pensions Committee on Nov. 17, 2015, in Washington, D.C. 

Dr. Robert Califf awaits the start of his nomination hearing before the Senate Health, Education, Labor and Pensions Committee on Nov. 17, 2015, in Washington, D.C.  (Win McNamee/Getty Images)

Biden is expected to announce Califf’s nomination later on Friday, almost 10 months into the president’s term.

Because acting commissioners may only serve for a certain amount of time, Biden was nearing the deadline for when he would be forced to name a replacement for acting FDA Commissioner Janet Woodcock. She’s held the position since Biden was inaugurated. 

“Dr. Robert Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden said in a statement Friday announcing the nomination.

“As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA. I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making. Dr. Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work being done at this critical moment.”

The White House did not provide comment on Manchin’s opposition to Califf’s nomination.

Walmart to stop accepting military prescription health insurance after Express Scripts ends deal

Express Scripts is one of those INFAMOUS PBM’s — which is now part of a the large INSURANCE COMPANY Cigna  https://en.wikipedia.org/wiki/Express_Scripts

Over the last few years, the major PBM’s have merged or being acquired by large insurance companies – some believe this has been done in order to be able to hide the OBSCENE PBM PROFITS in the parent company’s P&L statement.

This graphic shows how the PBM industry – these middlemen and their  various policies and procedures cause prescription prices to pts are GROSSLY INFLATED.  By a middleman industry that that provides little/no real contribution to improved healthcare to the pts they oversee the administration of the pt’s prescriptions.

here is a video that tries to explain how the typical PBM fits into our health care system and how their presence affects pts

Walmart to stop accepting military prescription health insurance after Express Scripts ends deal

https://fox2now.com/news/national/walmart-to-stop-accepting-military-prescription-health-insurance-after-express-scripts-ends-deal/

BENTONVILLE, Ark. (KNWA/KFTA) — Express Scripts recently ended a multi-year agreement to participate as a pharmacy provider for the Tricare network, affecting veterans and members of the military that fill their prescriptions at Walmart.

We were surprised to hear Express Scripts ended our multi-year agreement to participate as a pharmacy provider for the Tricare network just a few days after Walmart and Express Scripts signed an agreement on September 30 for Walmart to serve these members for the next several years. We value our Tricare and DOD customers and are disappointed in Express Script’s decision and we have requested more information from them to understand their decision. We have asked Express Scripts to honor the agreement we both recently signed. We know many members of the military, veterans and their families rely on Walmart for convenient access to affordable prescriptions and this decision will limit their options. We hope to come to a resolution to continue as a pharmacy provider for the Tricare network. Walmart will continue to offer everyday low pricing on generic drugs that can be accessed by all customers with or without insurance.

Luke Kleyn, Vice President of Payer Relations at Walmart

A local veteran reached out to KNWA/FOX24 News to inform us that he was told by Walmart that they will no longer accept his Tricare insurance, effective December 15, 2021.

Walmart has said it’s committed to supporting the active-duty military, veterans, and their families through various initiatives such as:

  • Meeting commitment to hire 250,000 veterans.
  • Within the last year, Walmart has hired over 49,000 veterans and 27,000 active-duty military spouses.  
  • Creating the Find A Future platform, which will further aid the men and women transitioning from the armed forces to civilian life.
  • Over the last decade, Walmart and the Walmart Foundation have granted more than $40 million to organizations that support veterans and military spouses.
  • Walmart is a long-time supporter of also providing pharmacy services to our military communities. 

Since 2013, Walmart has hired more than 400,000 veterans and military spouses at Walmart and Sam’s Club, according to a release. Since May 2021, Walmart has hired almost 30,000 veterans and military spouses – more than we ever have in a single quarter in the company’s history.

 

When Data Becomes Due Process

When Data Becomes Due Process

https://daily-remedy.com/when-data-becomes-due-process

It has been said that sin is not in the action, but in the reaction.

Similarly, the harm from data comes not from the data itself, but from its interpretation – how people react to what they see. As what they see can be quite subjective, changing from person to person.

The analysis of data is a notoriously quantitative field, defined by established rules of statistics. The interpretation of the analysis is different, far more subjective, varying based on the biases held by the person reviewing the data.

For federal agencies within the Department of Justice that investigate physician behavior, the interpretation of data analysis is used to initiate investigations and to secure convictions.

But in conflating objective data analysis with subjective interpretations, federal agencies introduce concerning levels of biases and variability in their investigative practices. As a result, the interpretations of laws governing physician behavior vary alongside the interpretations of data analysis – rendering the interpretation of data as due process.

The term is routinely cited but never fully understood. Due process is often discussed only in procedural terms in reference to legal investigations or deliberations in court. For example, if a law enforcement officer tampers with evidence or a prosecutor introduces materially false evidence, then we would expect the defendant to claim due process violations.

But procedural due process violations are only one aspect of due process. The other, more abstract aspect is called substantive due process. It focuses less on procedural violations and more on enumerated rights implicitly afforded through the Constitution. In 1905, the term was used by the Supreme Court in upholding the rights of bakers in New York City to work the hours they needed in order to prepare bread, finding work hour restrictions violated the rights of bakers to perform their job.

Substantive due process protects the right to work, to marry, and to raise children – essentially the basic functions we take for granted in our everyday lives. But in our increasingly complex world, many of these basic functions are becoming quite complex.

Something epitomized in healthcare, which has seen an influx of data turn basic patient care into complex models of technology-based care coordination. Data has now become synonymous with patient care – to the point that nearly all clinical decisions rely on some data point.

Something the Department of Justice has keenly noted, and now uses patient data to investigate the behavior of physicians to determine whether criminal behavior is transpiring. If a physician has higher than average reimbursements, then a physician is possibly committing insurance fraud. If a physician has higher than normal prescriptions of controlled substances, then a physician is possibly committing prescription fraud.

Effectively, the interpretation of the data determines probable cause. But correlating statistical probability with reasonable doubt leads to perilous interpretations that have been proven to be rife with bias – particularly in healthcare.

Numerous clinical studies and class action lawsuits have proven healthcare insurance companies use patient data to engage in discriminatory practices against disenfranchised patients, adversely affecting access to care. These are the entities that directly aggregate and maintain patient information – and even they cannot interpret data without bias.

For law enforcement to then take the same data and investigate crimes based on interpretations – already proven to be biased data – turns biases into evidence. Since most prosecutors are unable to discern between statistical noise and clinically relevant statistical trends, inevitably they will misinterpret patient data. This was most famously revealed when the Drug Enforcement Agency began correlating the number of opioid prescriptions with opioid related mortality.

Data analysis is complex by nature. We try to simplify it through interpretations. But to simplify something complex is a type of bias. And in the courts of law, we have assumed this bias to be evidence. When we examine criminal cases involving physicians, we usually see data included in the filings that allege to be the factual basis for the crime.

Yet we have never questioned the Constitutionality of using patient data this way. But in many criminal cases against physicians, the government essentially argues that data interpretations supersede a physician’s substantive due process rights. That over the course of a physician’s work, should any data aberrations arise, that physician can be subsequently investigated for potential crimes.

We would never allow the government to investigate a bakery based on production trends of bread. But we seem content to allow the government to investigate physicians based on trends in patient data.

Prosecutors justify this tactic by arguing that data is the principal means through which they can investigate physicians – a fair point, and by no means do we argue against using data for such investigations.

But we should not blindly assume we can use patient data in this manner. It was never intended to be evidence, and it has proven time and time again to be biased.

Instead we should closely examine the robustness of the data, case by case, determine if it meets objective legal standards required of evidence, and codify the legal definitions detailing how we use it in court.

As it stands currently, we are using data as due process without explicitly stating as much. In the silence, we have allowed prosecutors to introduce pernicious interpretations of data as evidence, which is a violation of a physician’s due process.

Until we directly address the constitutionality of this, pernicious legal interpretations will continue to deny physicians their right to a defense, and data will continue to pass for criminal intent.

And the courts will continue to enable government encroachment into healthcare.

FDA reports 100+ drug shortages nationwide

https://myfox8.com/news/fda-reports-100-drug-shortages-nationwide/

NASHVILLE, Tenn. (WKRN) – Recent supply chain disruptions are impacting everything from clothes to food, and even trips to the pharmacy. Popular drugs like Adderall, oxycodone, and insulin are running low nationwide.

In Tennessee, Steve Beasley said he’s having trouble finding iron dextran for his iron infusions. “I’m stuck between a rock and a hard place right now – none of the pharmacies around here can get it where they can compound it in-house.”

The FDA currently lists 112 drug shortages on its website. The reasons for the backlogs all vary.

“Some of the companies have discontinued making [iron dextran] for whatever reason,” Beasley said. “I don’t know, it just says manufacturing delays.”

The life-saving drug Narcan is being impacted too, with Pfizer’s website listing the availability of its injectable naloxone formulation as depleted. “A big reason there is a shortage – Pfizer had a manufacturing issue toward the beginning of the year,” Tara Schiller, CEO of SoberBuddy, said.

One group impacted by the shortage is the Opioid Safety and Supply Network (OSSN) Buyer’s Club. The group is the largest source of naloxone distribution directly to affected communities, accounting for 1.3 million doses in 2020 alone.

The OSNN Buyers Club stated they have an exclusive arrangement with Pfizer for the low-cost generic injectable. While there is not a widespread shortage of the product itself, the shortage specifically affects the group of programs. As of August 2021, OSNN Buyers Club programs are back-ordered by over a quarter-million doses of naloxone.

This shortage issue is creating a “perfect storm” scenario where overdoses are sky-rocketing, but access to life-saving medication is plummeting, said Schiller. “This group distributes in areas where there is no government infrastructure in purchasing naloxone.”

Nexstar reached out to the FDA about shortages and received the following response:

“The FDA is actively monitoring drug availability and we are committed to working with our public health partners, manufacturers and distributors to help mitigate shortages and make help ensure continued patient access to vital safe and effective drugs.”

‘Magic Mushrooms’ Get a Win for Depression in Early Trial, Drugmaker Says

‘Magic Mushrooms’ Get a Win for Depression in Early Trial, Drugmaker Says

— Psilocybin reduced depressive symptoms in largest trial of psychedelic drug to date

https://www.medpagetoday.com/psychiatry/depression/95579

Psilocybin, the drug compound found in “magic mushrooms,” reduced symptoms of treatment-resistant depression in a randomized phase IIB study, though was associated with some serious adverse events (AEs), drugmaker Compass Pathways announced by press release.Addiction tops the unfavorable side effects. Help 4 Addiction is easier if you are willing to get over it and focus on the benefits.

In the trial of more than 200 patients with treatment-resistant therapy who had stopped taking antidepressants before enrollment, a 25-mg dose of COMP360 psilocybin with ongoing psychological support led to a -6.6-point difference on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at week 3 versus a group who received a 1-mg dose of the product (P<0.001), and the difference remained significant through week 6.

A third arm of the study tested a 10-mg dose of psilocybin, but this showed no statistically significant difference over the 1-mg dose at week 3 (-2.5 points P=0.184). Results of the trial have not been peer-reviewed.

In the 25-mg group, 29.1% of patients achieved a remission (≥50% decrease in MADRS total score from baseline) at week 3, as compared to 7.6% in the 1-mg group. By week 12, these rates were 24.1% and 10.1%, respectively.

“Remission rates appear to be higher than seen in traditional medication studies,” noted principal investigator David Hellerstein, MD, of Columbia University in New York City, in a statement. “These findings suggest that COMP360 psilocybin therapy could play a major role in psychiatric care, if approved.”

During an investor call where Compass leadership presented the findings, Guy Goodwin, MD, the company’s chief medical officer and a professor emeritus of psychiatry at Oxford University, said the results in the 25-mg group “show evidence for durability of response” for psilocybin therapy.

Of potential concern, however, were higher rates of treatment-emergent serious adverse events (AEs) with the higher psilocybin doses. These serious AEs — which include suicidal behavior, suicidal ideation, and intentional self-injury — occurred in five patients in the 25-mg group (6.3%), in six patients in the 10-mg group (8.0%), as compared to one patient in the 1-mg group (1.3%).

Matthew Johnson, PhD, a professor of psychiatry and psychedelics at Johns Hopkins Medicine in Baltimore, told MedPage Today that the early data look encouraging. Yet without more detailed information, questions remain about the nature of the trial’s AEs, he said.

“Working with depressed people, these symptoms come with the territory. Suicidal behavior can encompass a broad range, from fleeting thoughts to more serious planning,” Johnson said. “It is possible that an effective session might put people in a more difficult place psychologically as they’re processing the experience, much like processing trauma. The treatment itself can bring up very difficult emotions and might potentially make things worse in the short-term.”

Because details of the patients’ reported suicidality weren’t explored further, it’s hard to assess in full, he explained.

Lars Christian Wilde, Compass’ co-founder and president, said during the investor call that the differences in serious AE frequency were not statistically significant between dosing groups. Suicidal thoughts, self-injury, and even suicidal behaviors are also common among those suffering from treatment-resistant depression, he noted.

The study, the largest to test the compound to date according to the U.K.-based company, included 233 patients with treatment-resistant depression. Patients were randomized 1:1:1 to COMP360 psilocybin at the three doses along with ongoing psychological support from therapists. Participants were recruited from 10 countries across North America and Europe. Notably, 94% of patients had no prior experience with psilocybin.

Overall, 179 patients reported experiencing at least one treatment-emergent AE, with more than 90% falling in the mild-to-moderate category (83.5% in the 25-mg group, 74.7% in the 10-mg group, and 72.2% in the 1-mg group), the company noted.

Researchers from the company are planning to start a phase III trial next year, which will likely focus on the 25-mg dose. The leadership team also announced that the company will be embarking on a phase II trial of psilocybin therapy in the treatment of post-traumatic stress disorder.