“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
Is there a difference between ESTIMATED numbers and FABRICATED numbers ? Sometimes with numbers from CDC .. it is often hard to determine how the numbers should be labeled. This article is from “ADDICTION PROFESSIONAL“.. the official news source for National Conference on Addiction Disorders.
Once again, the CDC discloses the estimated numbers of ALL DRUG OVER DOSE DEATHS, and then the narrative is shifted to OD’s from all opiates – legal and illegal… Then the “numbers” start getting a little fuzzier… overall 28.5% increase in ALL DRUG OVERDOSES, But, if you do the math… the OD’s from illegal Fentanyl analogs was up 35% and a mixture of illegal Fentanyl, methamphetamine and cocaine INCREASED 48% and then to BLUR the numbers even more …Deaths from natural and semi-synthetic opioids (such as prescription pain medications) also increased. Did the CDC actually not state the number of estimated deaths from pharma grade opiates and the author of this article just threw that in to try to perpetuate the fallacy that Pharma opiates are involved in OD’s – in a period where both the quantity of pharma opiates and pharma opiates being prescribed were reduced in number ? The attached graphic shows that during the 2010-2019 decade, OD’s using pharma opiates was virtually FLAT for the entire decade. (0.004%) and there is no delineation of pharma opiates OD’s the person who OD’d actually had a legal Rx for the opiate(s) showing in their toxicology – which would suggest a SUICIDE !
CDC: Annual Drug Overdose Deaths Top 100,000, a Record High
According to provisional data from the Centers for Disease Control and Prevention (CDC) National Center for Health Statistics released this week, there were an estimated 100,306 drug overdose deaths in the US for the 12 months ending in April 2021, a record high and a 28.5% increase over the same period a year prior.
Opioid-involved deaths in particular have spiked, with the potent, highly concentrated synthetic fentanyl playing a significant role. CDC estimates the number of opioid-involved deaths increased to 75,673, up from 56,064 year-over-year. The presence of fentanyl is also being linked with deaths involving psychostimulants such as methamphetamine and cocaine, as dealers mix fentanyl with other drugs. Psychostimulant-involved deaths were up 48% year-over-year. Deaths from natural and semi-synthetic opioids (such as prescription pain medications) also increased.
“What we’re seeing are the effects of these patterns of crisis and the appearance of more dangerous drugs at much lower prices,” Nora Volkow, MD, director of the National Institute on Drug Abuse, told CNN. “In a crisis of this magnitude, those already taking drugs may take higher amounts and those in recovery may relapse. It’s a phenomenon we’ve seen and perhaps could have predicted.”
Overdose deaths increased in all but 4 states: Delaware, New Hampshire, New Jersey, and South Dakota. The states hit hardest were Vermont, which saw a 70% year-over-year increase, followed by West Virginia (62%), and Kentucky (55%).
Anne Milgram, administrator of the Drug Enforcement Administration, told the Associated Press that cartels in Mexico are producing fentanyl and methamphetamine with chemicals acquired from China, and distributing the illicit substances across the United States. DEA has seized a record 12,000 pounds of fentanyl this year, Milgram said.
In an address to attendees of the Rx Drug Abuse & Heroin Summit in April, US Secretary of State Antony Blinken said in prepared remarks that disrupting the flow of opioids, especially synthetics such as fentanyl, was “an urgent national priority.” Blinken said the State Department has pressed China to address the production and sale of precursor chemicals used to produce synthetic drugs, and has collaborated with Mexico to cut down on trafficking across the southern border of the United States.
NEW ORLEANS — Patients taking the new, ultra-expensive thyroid eye disease drug teprotumumab (Tepezza) are typically tolerating ear-related side effects, with some saying they’re more interested in protecting their vision than their hearing, reported an ophthalmologist. However, if you’re looking for a lasik eye surgery specialist in Charlotte, you can check here!
One patient, for example, insisted on continuing the treatment despite hearing loss, said Suzanne Freitag, MD, of Massachusetts General Hospital in Boston, during a presentation here at the American Academy of Ophthalmology annual meeting. “She was arguing with me: ‘I want my eyes, I don’t care as much about my ears.'”
Hearing loss is the most significant side effect linked to teprotumumab, which received FDA approval in 2020 and can cost up to $400,000 for a full 6-month treatment course, said Michael Kazim, MD, of Columbia University in New York City. The drug treats thyroid eye disease, also known as Graves’ eye disease, an autoimmune disorder that can cause bulging eyes and a long list of other ocular problems.
In addition to teprotumumab, much cheaper drugs for the disease, such as steroids, are available, noted Kazim.
Freitag said her clinic has treated more than 100 patients with teprotumumab. An analysis showed that 36% reported ear/hearing changes, the most common side effect other than muscle spasms (55%), and more common than several others, including fatigue (30%), nausea (25%), dysgeusia (18%), and diarrhea (17%). The ear effects aren’t just loss of hearing, she explained; patients also mentioned tinnitus and a feeling of fullness in the ear.
At least two California children were left sick after a clinic administered the wrong dose of the coronavirus vaccine to 14 kids.
“I’m here tonight to report my story because it’s unacceptable; you expect your medical professionals to give you correct doses,” parent Denise Iserloth told ABC7.
Iserloth said she took her two children, ages eight and 11, to Sutter Health pediatric vaccine clinic in Antioch over the weekend, where they received 20 micrograms of dosage instead of the recommended 10.
FILE – In this Oct. 5, 2021, file photo a healthcare worker fills a syringe with the Pfizer COVID-19 vaccine at Jackson Memorial Hospital in Miami. President Joe Biden’s most aggressive move yet to combat the COVID-19 pandemic is almost ready to see the light of day. The government is close to publishing the details of a new vaccination-or-testing rule covering more than 80 million Americans at companies with 100 or more workers. (AP Photo/Lynne Sladky, File)
All in, 14 children who visited the clinic on Saturday were given the wrong dose.
Sutter Health said in a statement that it warned the parents of the mistake, explaining, “As soon as we learned of this, we contacted the parents and advised them of CDC guidance in this situation.”
But Iserloth said she wasn’t made aware of the error until 10 hours after the shots were administered. Both of her children stayed home from school on Monday with bad stomach aches, and her oldest child fell down twice in the hours following the shot.
“I understand the mandate, I tried to comply with it, and my children now have been given a double dose and I don’t know the long-term side effects,” Iserloth said.
TORONTO, ON – MARCH 23: Nurse Brenda Lotakoun draws a dose of the Moderna COVID-19 vaccine as nurses from Humber River Hospital staff administer vaccines to residents, staff, and volunteers at one of B’nai Brith Canada’s affordable housing buildings on March 23, 2021 in Toronto, Canada. Canada’s vaccine program has been lagging due to supply shortages. Currently, 11 per 100 people in the country have been given at least one dose of the vaccine. Ontario area hospitals have established programs to bring the vaccine to hot spot areas and underserved communities to vaccinate residents. (Photo by Cole Burston/Getty Images) (Getty Images)
Her husband, Shawn Iserloth, added that the couple “assumed that there was more in place to prevent this from happening, but obviously at this place there wasn’t.”
A local area physician told ABC 7 that the children should be okay, and the symptoms should subside after a couple of days. He added that children were tested with 10, 20, and 30 micrograms during clinical trials.
“Headache, muscle aches, fever in some cases, chills, but they should go away in a day or two. So I would say hold tight, don’t worry too much and that’s all expected,” Dr. Chin-Hong said.
Sutter Health added that it is now reviewing how the mistake unfolded and how to prevent it from happening again.
“The safety of our patients is our top priority, and we immediately reviewed our processes to help make sure this doesn’t happen again. According to the CDC, patients who receive a vaccine with an incorrect diluent volume may experience more arm soreness, fatigue, headache, or a fever in response to the dose given,” Dr. Jimmy Hu, chair of the Sutter Health COVID-19 Vaccine Task Force, said in a statement.
Meanwhile, the Iserloths say they are waiting for an update on how the mistake happened to the 14 children.
“There has been nothing clarified as to how this happened to our children and the other 12 children involved and it is unacceptable and negligent, completely negligent on their part,” Denise Iserloth said.
The incident in California comes as nearly 100 children in Maryland were also given the wrong doses of the vaccine. The children received shots that were diluted more than recommended at a clinic in the South Lake Elementary School in Montgomery Village last Wednesday.
REPOST FROM OCTOBER 28. STILL WAITING FOR THAT PHONE CALL
Cori Copilevitz Passer » CVS Pharmacy
October 28 at 7:44 PM •0
My mother, who has a brain tumor, was given the wrong dose of her anti seizure medication by store number 8567 and had a seizure. Directly related to this mistake. I called the store and
was told a supervisor would call me. They did not. I called headquarters and could not wait on
hold for more than 30 minutes. I emailed customer service. Nothing. This has been over a
month ago. I’m so frustrated and angry and I want some acknowledgement of this mistake and
I want to know what is being done to stop this from happening again.
Pharmacist Ashleigh Anderson died on September 10, 2021. I did not know her but almost feel like I did from the loving and kind tributes of her family, friends, and colleagues that are posted on the website of the funeral home (Soller-Baker in Lafayette, Indiana). I extend my heartfelt sympathy to her family.
Ashleigh was employed at a CVS store in Indiana. While working at CVS on September 10 she felt ill and considered it necessary to leave. She contacted her supervisor who, according to several individuals, responded that she needed to stay at the store for up to 2 hours until a covering pharmacist arrived. One pharmacist informed me that “she was threatened with job abandonment” if she left before then. Before another pharmacist could arrive, she collapsed in the store. Ashleigh Anderson was 41.
I have complete confidence in the information that several pharmacists have provided me. I have attempted to contact CVS corporate headquarters and have left multiple voicemail messages to obtain information about this tragedy and to determine if the company is establishing a memorial fund and/or other tribute to honor Ashleigh. There has been no response. Some allege that CVS does everything possible to suppress news that would result in criticism and questions.
Many individuals provide me with social media postings in which they believe I would be interested, and I appreciate their doing that. Many of the comments are accolades for Ashleigh, the joy derived from working with her, and expressions of grief following her death. Other postings direct anger and outrage at CVS, with the following being just several examples.
“CVS has been killing its patients for years! Now they are apparently killing the staff too?”
“Every time I see the red heart logo, all I can think about is Ashleigh Anderson.”
This tragic situation demands answers and actions including:
A police investigation;
A state board of pharmacy investigation that includes a review of CVS policies and quotas/metrics pharmacists are expected to meet and criteria for determining hours of staffing;
The establishment of a policy by CVS that authorizes pharmacists or other employees who feel ill at work to leave immediately, even if the store must be temporarily closed.
The disclosure of the name of the CVS supervisor who “discouraged” Ashleigh from quickly leaving the pharmacy, and the names of the CVS personnel in the administrative hierarchy above the supervisor up to the CEO;
The establishment by the Indiana and American Pharmacists Associations of a memorial fund in honor of Ashleigh Anderson that would support efforts to protect the well-being of pharmacists and improve workplace conditions.
On the same day as I am writing this commentary, I received in the mail a large postcard from CVS Health to inform me that “We’re hiring pharmacists at CVS Pharmacy stores in Pennsylvania.” It continues: “Do you have a passion for helping patients navigate their health care journey? We do! Join our pharmacists as they bring their heart to patients and local communities.” I accessed the website identified (cvs.jobs/pharmacists) to learn more. I urge CVS pharmacists to review this information to confirm that your experience matches the description. Is this false advertising? We can’t continue to tolerate dangerous working conditions, and we can’t be silent! If it is important that you not be identified as the source of information, make your concerns known to me or others you trust to assure your confidentiality.
Medical Advocates: Dentistry, Pharmacy, Physicians
Letter to Senator Richard Durbin Chairman of Senate Judiciary Committee, Demand to begin Hearings of United States Drug Enforcement Administration “War Against Patients in Pain and Their Doctors and Pharmacist” and The Story of Renee Blare RPh of New Castle, Wyoming
NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., IN THE SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., LEROY BAYLOR, JAY K. JOSHI MD., MBA, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NDJOU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
“These agencies have failed to recognize a people’s chronic disease conditions of intractable pain, while further failing to understand or comprehend human suffering, the science of clinical medical treatment and the value of human life.”
Senator Dick Durbin,
Sir, we have a growing crisis in our Country in healthcare delivery where the DEA has been “busy haunting and raiding doctors’ offices, seizing assets, dictating opioid dosages, curtailing various classes of opioid and prescription medications so that there are shortages.”
(D) Senator Dick Durbin, Springfield, Ill Chairman Senate Judiciary Committee
The DEA in collusion with the United States Department of Justice is undermining healthcare in America, “turning once quality medicine into chaos.” Further, turning doctors, pharmacists, dentists into criminals, and the death toll to patients needing pain care is staggering and going virtually unreported.
“WE ARE LICENSED PHARMACISTS NOT CRIMINAL DRUG DEALERS”
The Story of Renee Blare must move you to act on DEA hostility toward our Doctors, Pharmacists, and Patients in Pain being Criminalized. Renee Blare is White and a Pharmacist, she and her husband James suffer from Chronic Intractable Pain.
Renee Blare RPh (disabled pharmacist) “I followed all the rules”
I am Black and a Pharmacist, My Pharmacy Pronto Pharmacy Tampa Fl., was raided by DEA “thugs.” The DEA admitted they conducted no investigation. My pharmacy followed all the rules.
Yet, I was not alone five other Black own Pharmacies were targeted we then organized and formed a working group called the North Star Pharmacist Group, and began identifying DEA Injustices.
August 29, 2019, Security Camera Captures DEA Raid on Pronto Pharmacy LLC, Tampa Florida
All of us are highly-trained Pharmacists and the DEA doesn’t know what they’re talking about in the care and treatment of Pain; more specifically, Chronic intractable Pain. This agency has become a Criminal Governmental Thug Organization, “Arm With Badges And Guns and Profound Stupidity.”
Senator Durbin, we demand you do something, we demand you call for a hearing and investigation on the DEA and DOJ. The death toll is Staggering. Please read Helen Borel’s RN, Ph.D., book, “The America Agony: The Opioid War Against Patients in Pain.”
Renee Blare’
“It is time to stop the torture and shame of being a pain patient in the United States”
Renee Blare, RPh (disabled)
My name is Renee Blare and I was born with a soft cleft palate and lots of challenges. This made me a shy, withdrawn child and one who was always trying to ‘catch up with the rest of the world. For some people, like my husband, it meant pounding anybody in the ground who dared to expect anything else or call them anything less but their names.
Pharmacist Renee Blare
For me? I was afraid of my own shadow much less anybody else’s. But as I grew a vein of determination and something much harder was forged within my soul. Why? Because the pain, much like that within my husband, of being mocked, hazed, bullied, and rejected for being different, turned into a strength.
Anybody who is born different for any reason understands what I’m talking about.
I say all of that to say this— I am a rule follower, not a land forger. Why?
This brings us to another part of my life. I have, for most of my life, found comfort in structure— rules. They have provided me a system or place of definition in a world of chaos and pain. This started when I was a child and I have used it my entire life.
Structure, logic, rules, science, pharmacy… my life has always been about a system of some sort to bring chaos and pain under control. Whether it be mental, emotional, or physical, I needed it to survive.
Until the Lord ripped all of that away one Spring. Pain consumed my life. Nothing I did brought it under control. Science didn’t have the answers. Logic only took me so far and structure? I couldn’t rationalize the situation into a neat, tidy box. And rules? That’s where we are today. Let’s talk about the little girl who has followed the rules
Renee — me — has, for the most part, been an exemplary student and citizen of her chosen career and country. She rarely challenged authority, much less her parents. Rules were made for the protection of all, and not to be broken. That’s how she believed and lived her life.
Renee followed the rules.
She was in by curfew
She never skipped school.
She went to college.
She became a pharmacist.
She did her job by the book. Protected her patients to the utmost of her ability, and followed the rules, the law, and the ethical code of conduct, but most of all, she abided by every oath she took— starting with the Pharmacist Oath.
The Painful Truth by Lynn R. Webster
Renee followed the rules.
And then I (Renee) became disabled and I discovered in America, rules, no matter who makes them, are made to be broken. My protection blanket betrayed me.
Rule Number One: The disabled are protected in the country from discrimination and abuse by the government. *ADA
This is the biggest lie in America. The Americans with Disabilities Act is not enforced for Chronic Pain Patients and Rare Disease Patients who are disabled of which I am one as well as my husband.
We are discarded like the newborn calf on the high plains of Wyoming in a spring snowstorm. We are left to die while the herd seeks shelter from the rancher’s fresh laid hay in the gated pastures of home.
Except, you see, in Wyoming, the rancher would BE the ADA and ACLU that the United States citizens have expected of old.
How?
Rancher in Wyoming
A Wyoming rancher braves the bitter cold and life-threatening territory and goes out into the storm. He rescues the hurt and suffering animal that can’t defend itself— the one or two, however many he needs to— and brings them back to the safety of the herd. He nurses them back to health if NEED BE. Why? Because they are part of HIS HERD. HIS HOME.
Symbol of Threat to Healthcare and Collusion
The Chronic and Rare Disease patients in this country are part of AMERICA TOO! We are hurt and suffering and DYING. We are lost in the storm. Who will come and save us?
The rules are broken. They are not being followed. They have lost their power in this country because nobody is enforcing them. Instead, they are making up their own as they go along.
What rules am I talking about?
LAWS ON THE BOOKS
American with Disabilities
Rare Disease Research
Orphan Laws
ADA
Veterans rights
Human rights
No Torture
NO LAWS
DEA threats/arrests disabled
DEA threats/arrest patients
DEA threats/arrest doctors
DEA threat/arrests dr/pts
No care for pain
No pain care for post-surgery, chronic pain, emergent, urgent care, childhood diseases,
I live in the United States of America and if I didn’t know better by looking at this list, I would swear I lived in a country that believed in torture. Or are we actually enforcing genocide and Third Reich tactics now? I’m not laughing. This is no joke.
Symbol of the Injustice Undermining The Healthcare in America
Do you think this will end with Chronic Pain and Rare Disease patients, America? Opiates are the most useful drugs in the American arsenal. They are not going anywhere! And they are NOT killing your kids, brothers, sisters, parents, and friends. What is?
ENFORCING GENOCIDE IN THE UNITED STATES OF AMERICA
The Conflict Between your Physician(Jeff Singer MD) and the Ignorance of Law Enforcement
SYNTHETIC FENTANYL. Look it up. It’s not a natural drug. It’s not a NATURAL OPIATE. It’s a concocted nightmare. It’s MADE IN A LAB LIKE THE CORONAVIRUS.
Think about that for a second. Who and what is killing the addicts in America? It’s not the doctors and Chronic Pain Patients who live in your communities and take care of you. It’s the people who work in a LAB ACROSS THE WORLD.
“The War Against Patients in Pain,” By Helen Borel RN., Ph.D.
AND YOU ARE TORTURING YOUR NEIGHBOR FOR THEM. AN INNOCENT PAIN PATIENT WHO HAS DONE NOTHING WRONG, NOT EVEN BROKE A RULE.
Thank you.
Rule Number Two: People are inherently good and do not hurt others intentionally.
I believe with my whole heart that everybody in this country has a chronic pain patient in their family or friend circle. They KNOW someone well who has suffered at the hand of the government over the past 5-10 years. And they are NOT an addict.
These people work at a professional job or maybe even healthcare workers. Someone you would never know suffer chronic pain or have a rare disease if you were to meet them as a stranger. Why? Because they are not DEBILITATED by their pain.
They don’t cry each morning after throwing up after rising from bed. They don’t need to stay in a recliner all day because they can’t stand or sit upright because the pain sends them to their knees. But that doesn’t mean they are NOT a Chronic Pain Patient. It means they aren’t as bad as the other one— yet.
Injustice on Pronto Pharmacy by DEA/DOJ
You see, you know me. You just don’t know it! What I am saying?
I’m looking at you in the eyes of your mom or sister who has MS or Fibromyalgia. I stare back at you in the smile of your best friend who fights arthritis in her knees every day at work and goes home to soak in the tub and then lather the cream on after maybe a glass of wine. I’m the one who tosses the paint on the canvas and fights the shoulder and wrist pain afterward. I’m the brother
I’m looking at you through the eyes of your mom who has MS and struggles to open that jar.
I’m in the smile of your sister who has Fibromyalgia that winces when she rises from the dinner table.
I’m with you when you wait for your best friend after work as she rubs cream on her sore arthritis knees and takes a pain pill.
I’m standing beside you when you toss the paint on the canvas but have to stop because your wrist and shoulder hurt too much to continue.
I’m the sore throat after eating a bag of chips with that too hot salsa reminding you to have the surgery you should have had four years ago but won’t because you know you won’t get pain relief afterward.
I’m the ringing in your ears because the pain has hit a high crescendo and you have held your breath too long.
Wyoming Lightening
I’m the pain in your fingers from holding your brother’s hand while he breathes through another long, trying muscle cramp from having no muscle tone in his leg from CRPS.
It’s time for the story to change. It’s time for America to stop being AFRAID AND DEFEND HER OWN PEOPLE.
Renee Blare, RPh (disabled)
Chronic Pain Alliance of the West (CPAW)
An affiliate of the National Pain Council
Thank You, Renee, for your words, Norman J Clement RPh., DDS
Norman J Clement RPh., DDS
FOR NOW, YOU ARE WITHIN
YOUAREWITHINTHENORMS.COM, (WYNTON MARSALIS CONCERTO FOR TRUMPET AND 2 OBOES, 1984)
THE NORMS
reference: The Lawhern Files
Opioids in 2021: Enforcement Strategies and Policy PrescriptionsOpioid deaths in the US rose 29% during the course of the recent COVID pandemic. More than 55,000 Americans die annually from opioid consumption. Overtaken to some extent by other events, the opioid crisis is still with us and might be getting worse. The four participants in this panel discussion brought a wealth of experience and insight to …www.youtube.com
The most common New Year’s resolution is to get healthier. And the New Year is a perfect time to make changes, and plan for a brighter future. So, why do only 12% of people achieve their New Year’s goals? This is how Exipure works.
The secret to developing a healthy habit lies in implementing small steps that are positive, specific, and achievable. Instead of setting another goal, here are 7 healthy New Year’s habits and the secrets to achieving them beyond January 2nd:
1. Start your day with a tall glass of water.
You’re already dehydrated when you wake up in the morning, so drinking water, broth, or herbal tea will help energize you, improve your complexion, and help regulate your blood pressure. An easy way to remember if you’re getting enough water is to drink half your body weight in ounces. For example, if you weigh 150 lbs, you should drink at least 75 ounces each day.
Make it easier by keeping water by your bedside as a reminder. Set a daily alert or app and sip water from a reusable bottle throughout the day. Click here to see more ways to increase your water and healthy liquid intake. Check out the latest Exipure reviews.
2. Walk for 10 minutes at a time. ‘Exercise more’ is at the top of most New Year’s resolutions lists. But it can be difficult or overwhelming to know the best way to begin. Start small if you need to since every little bit of movement adds up. Just 2 hours of exercise per week can improve your heart health, lung capacity, blood pressure, and weight. Make it easier by walking for 10 minutes each day. Go longer if you feel like it but commit to those 10 minutes to establish the habit. Gradually add minutes, distance, or more 10-minute walks into your day.
3. Take a day off to take care of your mental health. Making your health a priority can be challenging when you’re busy or taking care of others. The pandemic continues to add stress for all of us, which affects home, work, and school. Many people find it difficult to take a “sick day” to care for their mental health through it all. Here’s why. If you’re feeling overwhelmed by job stress, life changes, or family responsibilities, get the support you need from an MDLIVE licensed therapist. You can speak with someone from the privacy and comfort of home and have your appointment in a week or less compared to the weeks or months it takes to schedule an in-person visit.
Mr. Steve, may I ask you if a law changed with Klonopin refills recently? I’ve always been able to fill on day 30 from the previous fill. My doctor even gives me a script with 5 refills totaling 6 months. Now I’m being told by the pharmacy I have to wait until the 31st day. I’m in the 4th month of the 6. So it can’t be the provider. The “nitwits” in the past made me wait 31 days for my oral opiate prescriptions. I found out yesterday my pain pump doctor agreed it’s time to ditch the Flowonix pump 16 months since being implanted for a Medtronic.
I hope you and the Mrs. are doing well! Thank you for all you do. I see how hard you work for us, and I only see a fraction and it’s been so helpful.
Whoever this Pharmacist is, must have missed a number of very important facts concerning Benzo & opiates… especially when it comes to withdrawal. How anyone got a PharmD degree and didn’t learn that cold turkey withdrawal from a benzos – depending on the pt’s dose – can be fatal and when the pt is forced to go thru cold turkey withdrawal from both a benzo and a opiate – the risk of it being LETHAL goes up SUBSTANTIALLY. Follow up from this pt, the pharmacy was – unfortunately – a independent and the Pharmacist/owner BLAMED the Rx dept software on the issue… it was the owner who purchased/installed the particular software package in their pharmacy and it was the legal duty of the Pharmacist in Charge to get the software company to get the software FIXED… or find another software package that will properly function.
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 ?
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.
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.
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:
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”);
The third or “booster” Pfizer shot is identical to the above and remains under the EUA with limited use to certain categories of people;
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;
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
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.”