‘Healthcare is increasingly a fact-free zone for politicians’

‘Healthcare is increasingly a fact-free zone for politicians’

https://www.beckershospitalreview.com/hospital-management-administration/healthcare-is-increasingly-a-fact-free-zone-for-politicians.html

The majority of Americans see healthcare costs as very important to their vote in the midterm elections, which are roughly two months away. Yet healthcare is becoming more of a black box to ballot-casters and political candidates, healthcare policy analyst Paul Keckley, PhD, contends. 

“Healthcare is increasingly a fact-free zone for politicians seeking votes,” Dr. Keckley, principal of The Keckley Group, wrote in his Sept. 6 edition of The Keckley Report. His take may be especially pertinent given aggressive spending on political ads ahead of the Nov. 8 midterms, which is set to reach nearly $9.7 billion by Election Day, according to the tracking firm AdImpact, topping the record $9 billion spent in the 2020 presidential election.

Dr. Keckley reasons that facts on healthcare are increasingly inessential to political campaigns and voters by pointing to the following: 

1. Incomprehension of the U.S. healthcare system is acceptable. “Voters do not understand the U.S. system of health. Understanding the U.S. health system is not a competency required of lawmakers who govern it nor employers and consumers who use and pay for it,” writes Dr. Keckley. 

2. Voters rely on personal experiences to define U.S. healthcare. The quality of providers, insurers and medications is largely a subjective assessment, which can challenge fact and make for a tricky translation on ballots for healthcare at the state and federal levels. When it comes to providers, “‘Good hospitals’ are those that accept an individual’s insurance and are accessible; affordability matters but all are expensive,” Dr. Keckley writes. “‘Good doctors’ are those that are accessible in person and affable; all are presumed competent.” 

3. Public trust in the medical system has fallen. In 2022, 38 percent of Americans said they have a great deal or quite a lot of trust in the medical system, down from 44 percent the year prior and 51 percent in 2020, according to Gallup’s longstanding index of confidence in institutions. This runs parallel to decreasing trust in the federal government, Congress, public education and number of other public institutions. When “trusted sources are less trusted,” as Dr. Keckley put it, facts are more likely seen as negotiable. 

Find Dr. Keckley’s analysis in full here

Voices of Pain (Trailer)

Has INFIGHTING in the community been ratcheted up to being DISRUPTIVE or SABOTAGE ?

A Medical Student Realizes What It’s like to Be a Patient’s Loved One

A Medical Student Realizes What It’s like to Be a Patient’s Loved One

https://www.doximity.com/articles/1ff6ff1c-5928-47d5-8fe7-6ffccf7f4afc

As I flew home two days before my mother’s hip replacement, I was quite confident. She was getting an anterior hip replacement, a fairly common orthopaedic procedure done by a well-known orthopaedic surgeon in my hometown. After an entire surgery rotation and half of an internal medicine rotation, I figured medicine had toughened me up quite a bit. After 3 a.m. wake ups, overnight call, and helping a team juggle a list of 20 patients, my job at home seemed like it would be quite straightforward: What could be so hard about waking up early, driving 30 minutes, and helping out my mother with basic tasks until neighbors could help pick up the slack?

The day of the operation, we pulled into the hospital parking lot well before the break of dawn. I was no stranger to waking up early, but this felt different. As a medical student, I would be rushing into the hospital at this time in my scrubs with a long mental checklist of tasks to complete before pre-rounding with my team at 6 a.m. When I stepped into the hospital before, my role was always defined. I quickly realized that all of my knowledge about what happens behind the scenes of a surgical team was not the least bit helpful to my usually gregarious mother who was now eerily quiet. My mother and I sat in silence in the waiting room, bathed in harsh yellow fluorescent light that seemed to give everything a tint of jaundice. I must have picked up and put down at least five different out-of-date magazines in the time we waited for my mother to be called back. I was relieved when the nurse finally came out and called out my mom’s name. When we walked back to the pre-op area, I finally saw a place that looked familiar. That comfort didn’t last long: I sat awkwardly like a lump in the corner as the anesthesiologist poked his head in and the incision site was marked and initialed. My feet felt wooden as my mom was wheeled down the hall and I was given vague directions to the patient waiting area.

I tried to curl up in the ugly wooden chairs and occupy myself by envisioning what was going on in the OR. The lack of information, however, felt overwhelming. Was the surgeon running late? Did the circulating nurse have all the tools ready?

I tried to picture my mom’s face where I had seen so many other patients lie on the operating table but I just couldn’t think about her in the same way. While I cared about all the patients I had seen on the wards, they still felt at least one step removed from me, since I was a member of their care team. During surgeries, once the drapes were aligned properly, patients’ faces disappeared and in that moment, they became no more than the body upon which the attending was operating. Cholecystectomy patients became Triangles of Calot, colostomy patients became their long winding tubes of intestine. Try as I might, I couldn’t picture my mother in the same light. I couldn’t focus on a single podcast that I had downloaded for the wait, and eventually fell asleep waiting for word from the OR on two chairs that I had put together into a makeshift bed.

Fortunately, my mother’s surgery went well and her recovery was relatively speedy. Still, caring for her immediately post-surgery was more difficult than I had expected. I had helped patients ambulate down the hallway during their stays, but I had never been awakened four times in a night in order to support my mother from her bed to the toilet. When before I could blithely write “PT/OT,” now I was experiencing just a small taste of many patients’ families’ daily lives.

On my flight back to school, I couldn’t help but think of all the dismissive comments that I had heard about “difficult families.” From the way nurses pre-warned our teams about certain rooms to walking in and immediately sensing hostility, I caught myself often being annoyed when patient families frequently questioned treatment plans or expressed frustration that their loved one had barely improved since the last visit. Didn’t they know we were doing the best we could? I found myself huffing. If only they understood how complex medicine is.

Well, I’m pretty sure that even if they did have the benefit of medical education, how could you ever blame families for their emotions running high? That feeling of powerlessness and uncertainty about the fate of a loved one, even for something medically “routine” like a common surgery, is enough to send anyone into a tailspin. I am now more amazed by how gracious and understanding most families are. As physicians, we have the privilege of doing things when patients are admitted. We get to prescribe medications, give transfusions. We get to be active participants in care. We should remember that families get to have the special agony of waiting.

Interesting FACTS: how the bureaucrats are doing things – BEHIND OUR BACKS

  What I find interesting when all this COVID-19 stuff started…  they started giving out 3 different vaccination… there was actually a fourth vaccine, that the FDA never approved so we GAVE AWAY a couple of hundred millions of that vaccine to India or Pakistan.  the first three vaccinations, two were made using the mRNA process and the other (J&J/Jansen) used the same process that we have used for decades in making our annual flu vaccines.

Now, they only talk about “COVID-19” vaccines and side effects and/or adverse outcomes… they ALWAYS talk about COVID-19 vaccines – so segregation between the mRNA versions and the J&J version..  The new COVID-19 for this year… apparently only going to be available as a mRNA version.

Only tested in animals, the FDA SKIPPED their advisory panel. Normally, people who are enrolled in a clinical trial… know they are in a clinical trial.

I have been asked to share this 09-03-2022

Thank you for your message back. To be honest I’ve been a physical and mental mess the past 2 and a half weeks. I’m going to try to include 2 screenshots, 1 of the investment firm that bought SaveMart/Lucky chain of supermarkets a few months back, and the phone number and name, Joyce and Diana, to Ca State Sen Cabrallos office, whom I’m working with.
Back story, about 2 and a half weeks ago I read an article in my local newspaper, The Modesto Bee. In it, it says that Kingswood decided to close their in store pharmacies, starting the following Tuesday and ending on Labor Day. We got it extended to Sept 8th. Ca State law says they have to give customers 30 day written notice and find another pharmacy. The article stated it contracted with Walgreens. To this day there are still no signs in stores, as the article also said, and no letters received.
When I first read the article, I spent the first week calling all the pharmacies within an I can drive distance of me. I take both a long acting and IR opiate. Yes, I know red flag pills. State controls what pharmacy gets what, pharmacies can order, but get what they get when it comes to controlled substances. The Agency that oversees this, didn’t know until last week about SaveMart pharmacies closing. So I called, every pharmacy is as max customers, 1 pharmacy can’t get my opiate.
The following week, I called my State Sen, State Assemblyman, Congressman, 2 US Senators, Walgreens Corp, Kingsman, County Board of Supervisors, and my first plea of help from an advocacy group I have been in, since it’s beginning, but no longer part of. State Sen Cabrallo office answered the phone, and I spoke with Joyce, we spoke a few times that week. Game plan, get enough people to call the office, and/or their State Sen office and say cut the red tape and take the controlled medication normally delivered to SaveMart, and divide it with other pharmacies. If calling another State Sen, say Joyce from Sen Cabrallo office is heading this. This was my 2nd plea for help in advocacy group, and ignored again.
When I got thru to the higher ups at Walgreens Corp, this was the first they heard about it. They said they needed more time to absorb all the customers. That it can take up to 30 days to process and fill transfer prescriptions, and to tell people to get a fresh script sent to Walgreens, or whatever pharmacy they chose, before caught up in the transfer system. 3rd plea, and I reached out to every news agency that ran an article/report on this, so they can put an update in. Those on line saving medications need to know, they can go up to 30 days without their medicine. Now it’s gone past affecting just CPPs. My Board of Supervisors contacted HSA, MediCal, etc to let them know and to make phone calls. We all want an investigation into Kingswood, who won’t return anybodies phone calls, but right now we are working on cutting red tape. Everyone is running around like a chicken with their head cut off. My BP hit 220/110, I’m barely sleeping, I’m puking from stress, and this is on top of other medical issues.
Customers of SaveMart/Lucky pharmacies are to take a picture, if can, of no signs in store/pharmacy.
Ca customers are to file a complaint the State Pharamacy Board at pharmacy.ca.gov
Have them call their State Senator and tell them Sen Cabrallo is working on it, we will be working on Legislation if she gets re elected, but I don’t think anyone is running against her. Contact Joyce or Diana at her office.
Call their Dr and have fresh scripts sent to new pharmacies asap.
My Congressman Josh Harder office took a “concern” paper. He won’t lift a finger when it comes to pain meds. Sen Cabrallo office and House Oversight Committee of Ways and Means put him on “notice”. Assemblyman Adam Gray has not returned any messages, you only get his voice-mail, along with both US Senators.

DEA increased confiscating Cannabis plants – to protect states’ tax revenue from legalized MJ ?

A recent annual report from the Drug Enforcement Administration (DEA) revealed a significant increase in cannabis-related arrests in 2021. Last year, the agency confiscated more than 5.5 million cannabis plants and arrested approximately 6,600 people, a staggering 32% increase in arrests compared to 2020. This is part of a concerning nationwide trend where cannabis-related arrests continue to rise despite more states embracing decriminalization policies and implementing adult-use legalization laws.

The DEA is just one of many local, state, and federal law enforcement organizations enforcing cruel and destructive cannabis prohibition policies nationwide. Across the country, over half a million people are still being arrested for cannabis-related offenses every year as states that maintain prohibition intensify their crackdowns – particularly in communities of color.

Could all this DEA action against MJ be, because the states – abt 40 – are not getting the tax revenue they expected from legalizing MJ… because the bureaucrats taxed the crap of the entire MJ industry from growth to sales… and the cartels.. came in and under cut the local retailers price.

MY BROTHER IS DYING IN EXCRUCIATING PAIN FROM ALS, “HE ONCE WAS A HERO: ” THE TALE OF TWO MEDICAL TREATMENTS”

MY BROTHER IS DYING IN EXCRUCIATING PAIN FROM ALS, “HE ONCE WAS A HERO: ” THE TALE OF TWO MEDICAL TREATMENTS”

https://youarewithinthenorms.com/2022/09/02/my-brother-is-dying-in-excruciating-pain-from-als-he-once-was-a-hero-the-tale-of-two-medical-treatments/#respond

“IF EVER ONE THINKS THEY’RE TOO SMALL TO MAKE CHANGES, THEN THEY HAVE NEVER SLEPT IN A TENT WITH A MOSQUITO !!!”

BY

NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC.T. SPIRIT OF REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., WALTER F. WRENN III., MD., JULIE KILLINGWORTH, LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., 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 NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

WE ARE NOT POWERLESS, AND THROUGH OUR VIDEOS, WRITINGS, AND PHOTOGRAPHS WE WILL EXPOSE THE ABUSES AND TYRANNY JUST AS THE VIDEO WAS RECORDED BY THE CELL PHONE CAMERA OF YOUNG DARNELLA FRAZIER, BORE WITNESS TO THE MURDER OF GEORGE FLOYD THE BLOG youarewithinthenorms.com BARES WITNESS AND BOTH ALLOWS THE SYSTEM TO BE HELD ACCOUNTABLE”

WALTER R. CLEMENT

RETIRED DETROIT POLICE SARGENT WALTER R. CLEMENT IS BEING DENIED ADEQUATE PAIN CARE BY THE LAW

My brother is dying from Amyotrophic Lateral Sceloris (ALS), an extremely painful neurologic chronic disorder, and the medical treatment has been deplorable.

The current physician training is designed around torture in not treating pain. This is especially if you are black and live in Detroit, where many pain maintenance treatment centers have mostly been shut down by DOJ-DEA, and the pain care one does receive is highly inefficient.

Now, let’s fast backward 30 years ago; our mother suffered from ALS. However, the doctors at that time treated her pain. Our mother never was allowed to suffer pain from the excruciating powerful muscle spasm; times have seemingly changed.

What happens if, God forbid when it becomes my turn? Will I be required to suffer, too, like my brother and our dad did at 104 years of age, of being denied access to proper pain care by misplaced law enforcement medical policies criminalizing pain care?

OUR DAD DIED SUFFERING NEEDLESSLY FROM PAIN AND BEING STARVED OF HEALTHCARE, “TOO OLD TO LIVE

AMERICAN HEALTHCARE: “IS BEING TOO OLD TO LIVE”

Like our dad and mother, my brother had great insurance after retiring 35 years from the Detroit Police Department. He had experienced everything from being a patrolman, scuba diver, swat team member, being shot by a gunman, and the ultimate from having to return fire.

WALTER R. CLEMENT

NORMAN, I’M LOSING HOPE

Walter Clement June 2022:

“Norman, I’m losing hope; I’m in so much pain I have tried to learn to live with it…I can not walk, I’m losing my speech, and I cannot clean myself… “the pain in my cervical spine is unbearable…I’m losing my mind…. the doctors are giving me nothing for the pain except for gabapentin, and it is not working… they ignore my complaining…I’m suffering… I’m being tortured…can you help me, Norman…”

“…my pain is so intense that parts of my body seem to shut down…”

CRIMINALIZATION OF PAIN CARE

Medical care and patient safety are under attack. Physicians spend years training to be able to take care of their patients safely. However, legislators with no medical training are passing laws signed into law by governors without medical training.

Would any of these individuals let an untrained individual take care of their medical needs?

Brandy McMillion Chief Federal Prosecutor of Pain Care Physicians in Michigan….Shelley Neth writes: “What the DEA has done by infiltrating medicine has killed people. People are suffering from deteriorating health due to the inability to live with the pain. Others have had to stop working and have lost their quality of life. None of this was necessary, all of it misdirected and cruel.
I want to send an official complaint to the UN Human Rights Council and would love to do so at a UN Council meeting, just as Native Americans did a few years ago.
It is said that Wayne F. Pratt, Chief of the Health Care Fraud unit of the U.S. Attorney’s Office for the Eastern District of Michigan, has saved Medicare nearly $1 billion and has done more to fight health care fraud than almost anyone else in the U.S. Department of Justice.“Emboldened by the medically intrusive 2016 CDC Guidelines, he and DEA operatives have deputized themselves with greater powers to raid innocent doctors’ medical practices even more invasively,” 
Retired Detroit Police Officer Walter R. Clement suffers from the ravages of ALS and cannot get proper pain care treatment.

..”DO THEY EVER FEEL OUR PAIN..”

Walter Clement December 2021:

“I cry at night because my pain is so intense. Yet no one gives a dam. You fight for masks, infrastructure, budgetary crisis, and the right to carry a gun—none of these matters to me.

a) Where are all my rights?

b) Where is my justice to be free or manage my pain?

I went to a doctor, yet he lost his license due to treating pain. I was stunned to find that many doctors are in prison because they treat and manage patients in pain.

As my tears fall, where were all the people that could correct this matter? I can no longer carry my weapon. I can no longer take my wallet out of my pocket. I can no longer work out at the gym. I can no longer cook my food. I can no longer wash my back or clean my behind. I can barely dress. I can barely feed myself. My pain is so intense that part of my body seems to shut down.

All of this is because of pain. No one seems to give a damn about my pain and my suffering.  I’m seeing attempts to control what they think is criminal contempt, yet I am suffering.

Walter R. Clement and Richard Clement

I am hurting; I am in chronic pain;

c) What did we build America for, for the people, or for the ideological philosophies that pain management is a crime?

d) Where are the judges, and where are the elected officials?

I dare you to stand up for the people to be free of pain. I dare you to stand up for the doctors who treat people who are in pain. As I suffer, my wife suffers, my kids suffer, my family suffers, I see and feel that our elected officials have failed us.”

WALTER R. CLEMENT DETROIT POLICE UNDERWATER RESCUE AND INVESTIGATION

Walter F. Wrenn MD, April 2022:

Why do they believe they can write and pass a law without medical knowledge?

This has to be the absolute example of stupidity. Politics and the misplaced energy spent on attacking abortion have fueled this dangerous and unprecedented behavior. Medicine and Politics do not mix and set a dangerous precedence. What other medical conditions will legislators pass laws against?

“I once was a hero.”

FOR NOW, YOU ARE WITHIN

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WATCHING OUR DAD(ERLIN CLEMENT SR, 104 YEARS OLD, BEING STARVED AND DENIED PAIN CARE AND TREATMENT IN AUGUST 2021

Is the war on drugs evolved into a covert genocide/population control ?


This video has some conspiracy theories “vibes”…but… Joe Biden during Obama’s run for re-election in 2012 .. stated that he was going to find a cure for cancer… that was 10 yrs ago… and the law talked about in this video talks about the Beau Biden, cancer, moonshot & opiate crisis.  I may have missed it, but I had not seen anything announced as “cure for cancer”

What I do remember from Physics in high school and college is that electrons flow from negative to positive… and the Protons they talk about in the video would be a POSITIVE CHARGE and the earth around us is a NEGATIVE CHARGE.  

Every electrical plug and electronic gadgets use a positive and negative side attached to our electrical system.

Today they have announced that the “new Covid-19” vaccine is going to be made with the mRNA process and will contain the ORIGINAL COVID-19 vaccine & “in theory” will address mutations BA.4 & BA.5.  However, they are releasing this vaccine with only being tested on animals and they are “guessing” about it will be effect on BA.4 & BA.5.  The FDA skipped their advisory panel opinion of this vaccine… HIGHLY UNUSUAL.

I can’t help but notice that J&J/Jansen COVID-19 vaccine is no long in the game… only two mRNA versions.  We passed on those mRNA versions the first time around, too new and too untested for me, and we got the J&J/Jansen vaccination and booster… and we are still alive.

The last decade we were involved with 4 major wars and upwards of one million – mostly young men – were killed.. we just finished 20 yrs in Afghanistan and a lot fewer were killed but our healthcare system had improved so much from Vietnam, we untold number of our armed services coming home with TBI, limbs missing, and just badly broken bodies and our VA system is not properly funded nor has the facilities to manage all these broken bodies. 

By the middle of this decade, the illegal fentanyl is poised to killed near 500,000 – more than was killed in WW-2 and likely to hit 1,000,000 by the end of the decade. The vast majority are in the 20-45 y/o age group. Similar to those killed in a major war ?  Some sort of genocide – population control – without all the broken bodies that a major war produces and all the $$$ to care for them.

Here’s What to Know About Fall COVID Boosters

Here’s What to Know About Fall COVID Boosters

Experts confident in safety, but questions remain about efficacy

https://www.medpagetoday.com/special-reports/exclusives/100482

The CDC’s Advisory Committee on Immunization Practices (ACIP) will weigh in on newly authorized fall COVID boosters this week, in a manner unprecedented during the pandemic — without data from human clinical trials.

While most experts agree that there are no safety concerns, and many support the FDA’s attempt to keep up with viral variants, others have pointed out gray areas and open questions when it comes to Omicron-targeting bivalent vaccines.

That includes whether boosters with components targeting Omicron would offer a significant advantage in terms of efficacy — particularly, protection against infection — over boosting against the ancestral strain of the virus alone.

Regulatory Recap

To recap, the regulatory process for fall boosters started earlier this summer. On June 28, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19-2 to recommend the use of an Omicron-specific component in future boosters. Their review was based on human clinical trial data from a bivalent booster containing the ancestral strain and the BA.1 variant, showing sufficient levels of neutralizing antibodies after the fourth dose.

But most committee members voiced support for a bivalent vaccine that included the ancestral strain plus the BA.4/5 variants, even though data from a human clinical trial wouldn’t be available before fall.

That would make the authorization process for this and possibly future COVID boosters similar to that for annual influenza vaccines, which relies on immunogenicity data from mouse studies.

Indeed, Pfizer has presented data from a mouse study, showing that BA.4/5 monovalent and bivalent boosters sufficiently raised neutralizing antibody levels against all Omicron variants.

Pfizer and Moderna are both starting human clinical trials of BA.4/5 boosters this month — a 30-mcg dose for Pfizer and a 50-mcg dose for Moderna — but those won’t be concluded before shots likely start going into arms in the coming weeks.

The Unknowns

While proponents tout the positives of moving quickly, others have raised several concerns, including not knowing whether a BA.4/5 boost will offer better protection against infection than another boost with the ancestral strain.

Paul Offit, MD, of Children’s Hospital Philadelphia, who participated in the June 28 VRBPAC meeting, told MedPage Today that the human data on BA.1 boosters were “underwhelming.”

Depending on the company, he said, there was a 1.5-fold to 1.75-fold increase in neutralizing antibody titers in the group that got the bivalent vaccines, and that’s “not likely to be a clinically significant difference.”

That could be related to “imprinting,” Offit said, which is also referred to as “original antigenic sin.” The concept is that the immune system response is bolstered against the strain that a person was initially exposed to.

“You largely are hooked into that ancestral strain, so it’s hard to boost in a big way with BA.4/5 vaccines,” Offit said. “If I gave a monovalent BA.4/5 vaccine to a 10-year-old with no previous vaccination or natural infection, you’d see a dramatic increase in neutralizing antibodies.”

Offit maintains that boosters aren’t needed in healthy adult populations at all because T-cell responses are conserved and recipients are thus protected against severe disease. Boosters, he said, are beneficial in at-risk groups: older patients (above 70), those with chronic conditions, and the immunocompromised.

John Moore, PhD, professor of microbiology and immunology at Columbia University in New York City, noted that the Pfizer mouse study data actually suggested better results with a monovalent BA.4/5 booster. Thus, it’s not clear why a monovalent booster isn’t moving forward at this time, he said.

Moore added that recent modeling data — albeit, a preprint, and not clinical data — suggest there wouldn’t be much of a difference in outcomes if people received a booster of the ancestral strain versus the Omicron-targeted booster.

“A great deal of time, effort, and money have now gone into making new boosters that will be little better than what we already had available in large quantities,” Moore told MedPage Today in an email.

He added it would be a “mistake if the public was persuaded that the new boosters are a super strong shield against infection, and hence increased their risk and exposed themselves to more virus.”

Several experts also expressed concerns that if the public perceived that the bivalent boosters were problematic because they only have animal data behind them, hesitancy could increase. That’s troubling given that only about 30% of the U.S. population has taken a booster dose, they said.

Still others think FDA is on the right track. Robert “Chip” Schooley, MD, an infectious diseases expert at the University of California San Diego, told MedPage Today in an email, “I think the call was the right one.”

“Coronavirus-induced immunity (whether vaccine- or infection-driven) wanes quickly and we have a large number of unboosted and under-boosted people in the population and are poised for a recrudescence of infection as people go indoors for the winter,” Schooley said. “Thus, there is not time for a comparative trial with clinical efficacy endpoints before the need to roll vaccination out in anticipation of the winter surge.”

He said he would have liked to see a clinical trial “embedded in the fall rollout in which people were randomized to a ‘legacy’ vaccine or a new one with a subset of patients being studied for immunogenicity versus a range of variants and clinical outcomes in the full cohort” — but that he wouldn’t advocate “continuing with the legacy vaccine for the next 6 months, which is what would be required to do a properly controlled clinical trial.”

He concluded that COVID vaccines are “likely headed toward where flu vaccines have gone.”

That certainly seems to be a foregone conclusion, as Biden administration officials have already touted the value of Omicron-targeted bivalent boosters. White House COVID-19 Response Coordinator Ashish Jha, MD, MPH, called it the “first major upgrade of the vaccines … in the last two and a half years.”

CDC Director Rochelle Walensky, MD, MPH, told the podcast Conversations on Health Care that bivalent boosters “shouldn’t impact safety at all.”

If the country waits for human data, she said, “we would be using what I would consider to be a potentially outdated vaccine. … It’s best to use a vaccine that’s tailored to the variant we have right now.”