Pfizer COVID-19 pill may not see approval for ‘months’ despite ‘impressive’ data

https://www.foxnews.com/health/pfizer-covid-pill-approval-months-impressive-data

The new Pfizer COVID-19 pill may not see Emergency Use Authorization for another month as health officials continue to highlight the promising effects it may bring. 

Dr. Anthony Fauci praised the data presented by Pfizer regarding the COVID pill, which someone would take within 48 hours of showing symptoms and continue to take for three to five days. 

Initial trial data indicates that the pill is up to 90% effective at preventing serious illness and death, which has prompted Pfizer and officials to seek Emergency Use Authorization (EUA). Under the

“If you look at that data, the data are really quite impressive,” Fauci said on ABC’s “This Week.” “If you get an antiviral, that up to 90 percent will prevent you from going from clinically recognizable infection to blocking. You’re getting to the hospital or dying in a 90 percent chance if you get treated within the first three days of the onset of symptoms.”

“That is big deal,” he stressed, but the timeline for approval may prove frustrating. 

The Pfizer COVID-19 vaccine concluded its Phase III trials and released data on Nov. 18, 2020. The Food and Drug Administration (FDA) took around one month to review the data and pass the EUA on Dec. 11. 

The vaccine did not receive full approval until Aug. 23, 2021, which presents a very grim expectation for the pill’s availability. 

That means the FDA would still need three to four weeks to pass the EUA for the Pfizer pill, and Fauci cautioned that it may be months before the public sees widespread availability. He also pointed to the production needs, which also took a month or two for Pfizer to reach mass-production and led to the initial prioritization of vaccinations at the end of last year. 

“It’s going to be months,” Fauci explained. “If you look, it’s a very complicated synthetic process to make the drug. It is not something that’s simple.” 

“So the companies revving up and getting more and more, but we’re not going to see widely available for at least a few months,” he added. 

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In March 2021, Sandra Leal, PharmD, MPH, FAPhA, CDE, was elected for a 3 yr term as APHA President and some time after that she was reportedly hired as a VP for CVS Health.. conflict of interest ?

APhA: Pharmacist burnout hits breaking point, impacting patient safety

https://www.pharmacist.com/APhA-Press-Releases/apha-pharmacist-burnout-hits-breaking-point-impacting-patient-safety

WASHINGTON, DC –  The Board of Trustees of the American Pharmacists Association issued the following statement today:

We have heard loud concerns of overwhelmed pharmacists in busy pharmacies. We have also heard of potential pharmacist protests to their employers in the form of a sickout.

Pharmacy workforce issues that lead to frustration and burnout are very real. They have been building for some time, but they have become more acute with the stressors brought on by the COVID-19 pandemic. Workplace conditions have pushed many pharmacists and pharmacy teams to the brink of despair. Pharmacy burnout is a significant patient safety issue. It is impacting patients today with delayed prescription fulfillment, unacceptable waits for vaccines and testing, and potential errors due to high volume, long hours and pressure to meet performance metrics.

Well-being

APhA and the National Alliance of State Pharmacy Associations developed the Pharmacy Workplace and Well-being Reporting (PWWR), a safe, confidential, and anonymous space for pharmacy personnel to report positive and negative workplace experiences. PWWR reports create a pool of aggregated data that will be used to influence and educate our pharmacy community and leaders—including those who can do something about it – on meaningful and actionable changes. The experiences and situations submitted via PWWR help tell a collective, powerful story that can spark change and improvement in well-being, delivery of care, and patient safety in pharmacies.

APhA unwaveringly supports our pharmacists and the work of pharmacy teams as they seek overdue action from employers to improve eroding workplace conditions. However, we strongly believe that actions such as a sickout where pharmacists would walk away from direct patient care is not an appropriate action. A profession that is rightly demanding action to keep themselves and their patients safe should not compromise public welfare by abandoning patients who rely on them. Serving patients and ensuring patient safety is core to the profession of pharmacy.

Pharmacists are caregivers, and we must address the fundamental issues causing burnout and frustration. The public, decision-makers, and regulators must be educated about, and recognize, the seriousness of our pharmacy teams’ negative well-being and the need for both additional resources and realistic expectations to safely provide patient care services. The value within our practices are the individuals who serve the health care needs of their patients and communities. Pharmacists are committed to serving these needs and have demonstrated this commitment throughout the pandemic. However, they cannot sustain this commitment without immediate changes.

Employers across the health care system must have meaningful dialogue with their teams that result in realistic expectations that are supported by appropriate staffing levels and procedures. These employers have an obligation to increase staffing in their pharmacies to promote safety and access for patients and improve well-being for their pharmacists and pharmacy technicians. 

Boards of pharmacy, who are tasked with protecting public safety and public health, including timely access for patients to needed medications and services, must also examine current experiences and regulations contributing to this issue, and take appropriate action.

Root causes

A significant contributing factor that causes under staffing and unrealistic performance metrics is a misaligned payment system that rewards volume and not value. Pharmacists and pharmacies are primarily reimbursed for dispensing a product, not for addressing the clinical needs of the patient. The payment system for pharmacy services is fundamentally flawed.

PBM issues

Pharmacy benefit managers (PBMs) are intermediaries who have siphoned tremendous profits from the prescription drug system, leaving pharmacies to depend upon unrealistically high transaction volumes with minimally viable staffing to stay in business. Pharmacy teams have been meeting a significant need within their communities during the pandemic through the provision of acute and chronic medications and associated services, including testing, vaccination, and treatments. These services are provided on top of a model that was stretched to its limit prior to COVID-19, due to the misaligned payment model.

Provider status

Pharmacists strive to optimize medication use and ensure that medications are taken correctly, but coverage is lacking for these clinical services. Pharmacists are health care professionals with training, experience, and knowledge as medication experts, and they provide clinical care related to those medications and the conditions they treat.

Pharmacists are not able to bill Medicare for their clinical services because they are not recognized as eligible providers under the Social Security Act. Other health care professions – including physicians, nurse practitioners, physician assistants, audiologists, and nurse-midwives – are all eligible providers who can bill for their services.

Solutions

There are both short-term and long-term remedies.

First: Employers must immediately address working conditions. Signing bonuses and free pizza aren’t enough. Pharmacies must be staffed appropriately so that pharmacists and pharmacy technicians have dedicated time for the safe dispensing of medication, safe delivery of clinical services such as COVID-19 vaccine administration, and adequate time to talk with and counsel patients about their medications.

Second: APhA is engaging in direct conversations with chain pharmacy leadership and other influencers to address the issues related to workload and well-being.

Third: Boards of pharmacy must engage in conversation with pharmacy team members, pharmacy management and organization executives to examine the following:

• Staffing levels needed to safely provide care and sustain timely public access to needed medications and patient care;
• Performance measures that jeopardize care delivery;
• Use of technology;
• Administrative policies and procedures that distract pharmacy teams from the delivery of patient care

Fourth: The underlying payment issues must be rectified. This includes reining in adverse PBM business practices and recognizing pharmacists as patient care providers in Medicare as well as Medicaid and private insurance plans. Until then, pharmacists will continue to run on fumes with high burnout and inadequate support.

APhA calls on anyone who can impact our pharmacy teams’ well-being and the safe delivery of patient care to address these issues now with their teams and those who can make a difference – employers, boards of pharmacy, and payers. In order to sustain public access to pharmacy services, relief is needed now. We stand with our pharmacy teams in making the case for timely change.

About the American Pharmacists Association

The American Pharmacists Association is the only organization advancing the entire pharmacy profession. Our expert staff, and strong volunteer leadership, including many experienced pharmacists, allow us to deliver vital leadership to help pharmacists, pharmaceutical scientists, student pharmacists and pharmacy technicians find success and satisfaction in their work, while advocating for changes that benefit them, their patients and their communities. For more information, please visit www.pharmacist.com.

Contact: APhA Media Relations; media@aphanet.org

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I need help! I’m thinking about taking on 10 more sick kids but I’ll need money to operate! I have Steve Ariens RPH Andrew Hohenthaner Johnna Magers Shirley Buck Carol Adams Dr. Anthony Mimms Dr. Norman, Cheri Mendes, Karen Wilkinson, and several others that work for free but I will be needing office stuff, transportation, food, and incidentals! This isn’t gonna be cheap and it’s done on a shoe string budget! Not everyone has access to the best Pharmacist in the world and the best Doctor’s on the planet and some of the best advocates on the face of the earth! Your only as good as the people you work with! I’ve been blessed with the best. My gift of gab combined with the best minds money can buy who donate their time is priceless! I’d appreciate the help as there are 93 other children who need our help. I’d love to try if we can muster up the money from the public. If we can get close I’d be up for the task! If not I’ll take all of them I can before APDF runs out of money lol ! Remember the news likes kids better than anything and this may very well be the eye opener. After the 10 they may fold and we can start a program where I can get some of the very best to travel and give lectures to the parents on how to advocate on their own? I’d love to bring in Mary, Tamera, Andrea, Red, Lisa, Jules, Anna, Mr Bill, Dr Tennant, Dr Colman, Kathy, Jonelle, Cathy and so many more great advocates! I’m mad and frustrated and devastated they can do this to children . Help me get there CPP or not I’ll take all the help I can get! General Public you have to see torturing kids is inhumane and if there’s ever a cause to help with,this is it! Help treat these kids. 5.00 or 5 hundred will help set things right! Help me as I’m desperate and don’t want to leave these babies hanging. 93 kids and we helped 4! We can do better and come together I know we can! We love NPC & IPF CIAAG & PPSGM&F & many more.. WE CAN DO THIS PEOPLE

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Of course they won’t show me which comments that they consider go against their community standards and of course can’t appeal their opinions/edicts.

I could not even allow you to take a screen shot of the notice and trying to open it GOES NO WHERE…I guess they think that most of their supporters are working off their smart phones … but in my case they were wrong…

I work off a laptop and have a smart phone – and I  am smart enough to take a picture of my laptop screen and move the picture to my laptop.

Maybe this graphic might suggests where they keep a copy of their community standards.

Of course, from I can find out this is all the actions of RICHARD MARK and his harem of minions filling untold number of complaints with FAKE BOOK about my blog was a scammer..  Because Richard Mark – I am told – got pissed at me over a post I made TWO YEARS AGO….

From what I am told is that Richard Mark is now homeless and in the hospital and the FBI has interviewed at least two of the chronic pain pts who he conned/scammed money out of, by FBI agents.  I have been told that even his girlfriend/wife has turned him in…trying to CYA herself.  All his conning/scamming chronic pain pts – he may end up with THREE HOTS AND A COT

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California pot companies warn of impending industry collapse

https://www.foxbusiness.com/features/california-pot-companies-warn-of-impending-industry-collapse

Industry leaders asked for an immediate lifting of the cultivation tax

Leading California cannabis companies warned Gov. Gavin Newsom on Friday that the state’s legal industry was on the verge of collapse and needed immediate tax cuts and a rapid expansion of retail outlets to steady the shaky marketplace.

The letter signed by more than two dozen executives, industry officials and legalization advocates followed years of complaints that the heavily taxed and regulated industry was unable to compete with the widespread illegal economy, where consumer prices are far lower and sales are double or triple the legal business.

Four years after broad legal sales began, “our industry is collapsing,” said the letter, which also was sent to legislative leaders in Sacramento.

The industry leaders asked for an immediate lifting of the cultivation tax placed on growers, a three-year holiday from the excise tax and an expansion of retail shops throughout much of the state. It’s estimated that about two-thirds of California cities remain without dispensaries, since it’s up to local governments to authorize sales and production.

The current system “is rigged for all to fail,” they wrote.

“The opportunity to create a robust legal market has been squandered as a result of excessive taxation,” the letter said. “Seventy-five percent of cannabis in California is consumed in the illicit market and is untested and unsafe.”

“We need you to understand that we have been pushed to a breaking point,” they told the governor.

Newsom spokeswoman Erin Mellon said in a statement that the governor supports cannabis tax reform and recognizes the system needs change, while expanding enforcement against illegal sales and production.

“It’s clear that the current tax construct is presenting unintended but serious challenges. Any tax-reform effort in this space will require action from two-thirds of the Legislature and the Governor is open to working with them on a solution,” Mellon said.

Companies, executives and groups signing the letter included the California Cannabis Industry Association, the California arm of the National Organization for the Reform of Marijuana Laws, the Los Angeles-based United Cannabis Business Association, Flow Kana Inc., Harborside Inc., and CannaCraft.

In a conference call with reporters, Darren Story of Strong Agronomy said tough market conditions forced him to cut loose more than half his staff. He said taxes that will increase next year make it an easy choice for shoppers. With prices in the underground half of what they see on legal shelves, he said “most consumers are going to take off.”

The companies asked Newsom to include their proposals in his upcoming budget proposal, which will be released early next year.

“The solution to these issues and the possibility of saving this industry lies in your hands,” they wrote.

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The Hippocratic Oath: The Original and Revised Version

https://doctors.practo.com/the-hippocratic-oath-the-original-and-revised-version/

The Oath was rewritten in 1964 by Dr. Louis Lasagna, Academic Dean at Tufts University School of Medicine and this revised form is widely accepted in today’s medical schools. The modern or revised version of Hippocratic Oath is:The Revised Hippocratic Oath

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WALTER F. WRENN, III M.D. A CLEAR UNDERSTANDING OF ADDICTIONS, PAIN, DEPENDENCY

https://youarewithinthenorms.com/2021/12/18/walter-f-wrenn-iii-m-d-a-clear-understanding-of-addictions-pain-dependency/

Walter F. Wrenn III M.D

A CLEAR UNDERSTANDING

There have been many theories surrounding addiction. There have been papers written by so-called experts who sight statistics to back them up.

A medical specialist with board certification in pain and addiction has been established. Recommendations and laws have been enacted without a clear understanding of the problem.

DONATE LEGAL DEFENSE

Health care providers have been arrested and convicted of violations of these laws and recommendations. Despite all the actions taken deaths from addiction continue to rise.

Individuals continue to be deprived of adequate pain medication causing them to either go to the streets for relief overdose and die or commit suicide because the pain is too unbearable.

These individuals are ignored when reporting deaths from a drug overdose. As a person who grew up in the inner city, I had a front-row seat watching the consequences of addiction.

The idea that opiate prescription medication is responsible for the opiate epidemic ignores the actual truth.

ADDICTED TO HEROIN

In 1954 I saw people who were addicted to heroin. One of my friends was curious.

The young lady who was the object of his curiosity first tried to discourage him. Eventually, she decided to help him experience injecting himself with heroin. I watched this event as the heroin was being prepared in a spoon and drawn into a syringe.

The tourniquet a rubber tube was tied tightly around his arm. The needle was inserted and the tourniquet was released. The heroin was slowly pushed by the young lady into his vein.

He started to feel the effects of the heroin and then entered into a euphoric state. He said I should try it. I told him he was crazy and I wasn’t putting anything into my body. I remember that event until this day. This individual was a good student. 

He finished high school and was accepted to Lincoln University in Oxford but his addiction was so severe eventually he was dismissed from Lincoln moved to California and battled this addiction for his entire life.

Most addictions begin to like my friends. Curiosity and recreational use. Today it may begin with the use of a parent’s opiate pain medication left in the medicine cabinet. Again curiosity and recreational. 

The how and why can be debated. Ignored and not discussed even by physicians is the physiological action of opiates on the body and brain and the role of opiate receptors found in the body and brain.

Without this knowledge and understanding, no one can accurately talk about the cause of opiate addiction or how to treat it.

UNDERSTANDING THE MU RECEPTOR

Since the first opiate receptor, the Mu receptor was not discovered until 1972 any study prior to 1972 about addiction can’t be accepted by the medical community or the general public.

Also making studies more difficult is that it is almost impossible to study this unreliable group of individuals.

In order to properly address the problem of addiction, we need to examine our prior thinking and conclusions that have caused great harm to patients and health care providers.

We have to determine the physiological action of not only the Mu receptor but the Delta and Sigma receptors. Let’s study the problem first then do the appropriate clinical trials and then offer solutions. 

Walter F. Wrenn III M.D

FOR NOW, YOU ARE WITHIN

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Per Mona:  Cancer pain is no joke….it’s like living in eternal hell with no way out….it’s not necessary to have to suffer when you’re dying. Whoever said that?

This is a follow up from a post that made the first of the week  Update 12/15/2021:Denial of pain: University of Louisville Hospital- stage FOUR metastatic cancer

I tried to reach out to Mona & her Husband and was only able to leave voice mails and I got no return calls. Given that this Tik Tok was posted about midnight last night, apparently they did listen to the VM’s that I left.  I was very concerned about her and the actions of the pain doc that she was seeing while in the hospital and was the first time that this pain doc had seen here abt one week earlier.

In this video, she appears to look as if her pain is being managed much better than the pt that I saw in the hospital this past Tuesday.  Hopefully, her internists got back into the picture and got her back on her pain meds, that she had been taking – for some 5-7 yrs – before entering the hospital.

I never had the opportunity to speak with the pain doc and even though I requested to have the hospital’s patient advocate and the palliative care team on Tuesday – after waiting for FOUR HOURS…NO ONE BOTHERED to grant my request.

I was able to talk to those physicians that had overseen Mona’s radiation therapy that day and a second year resident that stopped by.  Each one, I impressed  my concerns about what was I hearing  about what Mona’s post discharge pain management would be and it was – IMO – NOT GOOD !  I tried to impress on them that someone – UP THE LADDER – needed to be made aware of what appeared to be inadequate pain management proposed.

Any practitioner that refuses to consider what the pt’s prior medication therapy that has worked well for the pt and decides to take the pt’s therapy in an entirely different direction lacks a lot of concern for the pt’s QOL and more may be about feeding the practitioner’s EGO.

While Mona’s prognosis is still not good, her QOL seems to be as good as it is going to get … and for that, I AM HAPPY.

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for year 2020, there is a reported 75,000 OD’d that involved ILLEGAL FENTANYL ANALOG – remember – according to Wikipedia – there is some 400 different Fentanyl analogs… with only one analog being a FDA approved for use in humans.  Remember the Vietnam war – a total of 20 yrs and a total of 58,220 USA soldiers died.  So in 2020, about 30% more people died from illicit fentanyl from China and Mexico and WE ARE NOT AT A DECLARED WAR WITH THEM. Or have they declared WAR ON US … and we just have not bothered to figure it out ?  Also remember Pearl Harbor and 911 attack when abt a total of 5000 died ? Still overall – fewer deaths than last year by illicit Fentanyl from Mexico & China

Fentanyl overdoses become No. 1 cause of death among US adults, ages 18-45: ‘A national emergency’

More adults between 18 and 45 died of fentanyl overdoses in 2020 than COVID-19, motor vehicle accidents, cancer and suicide

https://www.foxnews.com/us/fentanyl-overdoses-leading-cause-death-adults

Fentanyl overdoses have surged to the leading cause of death for adults between the ages of 18 and 45, according to an analysis of U.S. government data.

Between 2020 and 2021, nearly 79,000 people between 18 and 45 years old — 37,208 in 2020 and 41,587 in 2021 — died of fentanyl overdoses, the data analysis from opioid awareness organization Families Against Fentanyl shows.

Fentanyl is a synthetic opioid that can be deadly even in very small amounts, and other drugs, including heroin, meth and marijuana, can be laced with the dangerous drug. Mexico and China are the primary sources for the flow of fentanyl into the United States, according to the Drug Enforcement Agency (DEA). 

Comparatively, between Jan. 1, 2020, and Dec. 15, 2021, there were more than 53,000 COVID-19 deaths among those between the ages of 18 and 49, according to data from the Centers for Disease Control and Prevention (CDC).

“This is a national emergency. America’s young adults — thousands of unsuspecting Americans — are being poisoned,” James Rauh, founder of Families Against Fentanyl, said in a statement. “It is widely known that illicit fentanyl is driving the massive spike in drug-related deaths. A new approach to this catastrophe is needed.”

Rauh, who lost his son to an overdose, added that “declaring illicit fentanyl a Weapon of Mass Destruction would activate additional and necessary federal resources to root out the international manufacturers and traffickers of illicit fentanyl and save American lives.”

The DEA on Thursday announced a surge in the sale of fake prescription pills containing deadly opioids on social media platforms like Snapchat.

Experts believe there is a correlation between the impact of the coronavirus pandemic and the recent increase in fentanyl overdoses.

More adults between 18 and 45 died of fentanyl overdoses in 2020 than any other leading cause of death, including COVID-19, motor vehicle accidents, cancer and suicide. Fentanyl also killed more Americans in general in 2020 than car accidents, gun violence, breast cancer and suicide, according to the analysis of CDC data from Families Against Fentanyl. 

Fentanyl deaths doubled from 32,754 fatalities to 64,178 fatalities in two years between April 2019 and April 2021.

In the first five months of 2021 alone, more than 42,600 fentanyl overdose deaths were reported, which represents an increase of more than 1,000 fentanyl deaths per month compared to the same time period in 2020.

“Fentanyl has been found in all the drug supply. That’s why anyone using drugs, not just opioids, should carry naloxone,” Dr. Roneet Lev, emergency physician and former chief medical officer of the White House Office of National Drug Control Policy (ONDCP), said in a statement. “The only safe place to obtain drugs is the pharmacy.”

Overall drug overdose deaths are expected to surpass 100,000 in 2021, according to preliminary CDC data, representing a 28% increase between April 2020 and April 2021.

President Biden on Wednesday issued an executive order authorizing sanctions against any foreigner engaged in illicit drug trafficking or production.

“I find that international drug trafficking — including the illicit production, global sale and widespread distribution of illegal drugs, the rise of extremely potent drugs such as fentanyl and other synthetic opioids, as well as the growing role of internet-based drug sales — constitutes an unusual and extraordinary threat to the national security, foreign policy and economy of the United States,” Biden’s order states.

Fentanyl drug seizures at the border have reached record highs in 2021, according to data from Customs and Border Protection (CBP), as the Biden administration faces a continuing crisis at the southern border.

Border authorities have seized more than 11,000 pounds of fentanyl so far in fiscal year 2021, with less than one month to go, dwarfing the 4,776 pounds seized in fiscal 2020. CBP seizures of other drugs, including marijuana, cocaine and heroin have generally decreased since 2018.

Experts recommend people who use any kind of drug carry Narcan, a lifesaving medicine also known as naloxone, which has the ability to reverse symptoms of an overdose and potentially save lives, according to Family First Intervention.

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