Here’s What to Know About Fall COVID Boosters

Posted on September 1, 2022 by Pharmaciststeve

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.”

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Iowa: WAGS has some ‘xplaning to do to the Iowa Board of Pharmacy – and pays some FINE$

Posted on August 31, 2022 by Pharmaciststeve
Here is a recent blog post: VT BOP threaten to REVOKE the pharmacy license of ALL 32 WALGREEN PHARMACIES IN THE STATE

The IOWA Board of Pharmacy is putting some stores on PROBATION and imposing some fines on WAGS stores… to WAGS the fines are just “pocket change” but typically most state boards of pharmacy are stacked with non-practicing corporate pharmacists and don’t often hear about them biting the company that gives them a paycheck.  https://abcnews.go.com/Business/story?id=6552337&page=1

Date

The Iowa Board of Pharmacy (“Board”) took the following actions at its most recent meeting held August 24, 2022.

Walgreens 05721, Des Moines, entered into a Settlement Agreement and Final Order.

Walgreens 05941, Mason City, entered into a Settlement Agreement and Final Order.

Walgreens 04714, Des Moines, entered into a Settlement Agreement and Final Order.

Walgreens 07455, Waterloo, entered into a Settlement Agreement and Final Order.

Walgreens 359, Des Moines, entered into a Settlement Agreement and Final Order.

Walgreens 07454, Ankeny, entered into a Settlement Agreement and Final Order.

Walgreens 05060, Clive, entered into a Settlement Agreement and Final Order.

Walgreens 07967, Clive, entered into a Settlement Agreement and Final Order.

Revive Rx, nonresident pharmacy, Houston, TX, entered into a Combined Statement of Charges, Settlement Agreement, and Final Order.

Greenwood Compounding Pharmacy, Waterloo, entered into a Combined Statement of Charges, Settlement Agreement, and Final Order.

Walgreens 06678, West Des Moines, entered into a Combined Statement of Charges, Settlement Agreement, and Final Order.

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Just sharing… so that everyone is on the same page

Posted on August 30, 2022 by Pharmaciststeve

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Survey: majority (62%) indicated that PBMs help lower net drug prices: 38% of the more than 950 respondents worked for a PBM

Posted on August 29, 2022 by Pharmaciststeve

2022 Pharmacy Survey Results: PBMs

2022 Pharmacy Survey Results: PBMs | Part 6 (managedhealthcareexecutive.com)

Fairly or not, in the blame game for high drug prices, pharmacy benefit managers (PBMs) often come up as the middlemen who make profits but don’t add much value.

The respondents to our 2022 Pharmacy Survey beg to differ.

A strong majority (62%) indicated that PBMs help lower net drug prices. Only a small group (21%) thought antitrust action to break up the dominant PBMs should be considered. An even smaller group (15%) agreed with strengthening the audit rights for employers and government payers.

But these results are not surprising considering that about 38% of the more than 950 respondents to the survey said they work for a PBM.

The survey was distributed online in late June and early through various channels by Managed Healthcare Executive® and our colleagues at Pharmacy Times®.

Of the remaining respondents, 24% said they worked for a payer organization, 21% said they worked for a provider, 9% for a pharmaceutical company and 8% for consultants (the total is more than 100% because a few respondents said their employers were in more than one sector).

The PBM industry is criticized for being opaque and keeping rebates and pricing arrangements secret. About half (49%) of the respondents said they favor imposing transparency rules on PBMs, and sizable minority (44%) favored requiring formulary placement to reflect the total cost of drugs.

And about half (48%) said value-based contracts between payer and drugmakers would slow the growth in drug expenditures, and about the same proportion (47%) said revising benefit design to create incentives to choose the most cost-effective option would help.

Inflation Reduction Act:

All of prescriptions covered under Medicare Part D or Medicare Advantage – are provided by FOR PROFIT INSURANCE COMPANIES and the PBM companies that the major ones are owned by a Insurance Company..

Were not included in the  Inflation Reduction Act… and those entities have since the beginning of Medicare paying for medication – JAN 2006 –

You will not see these two for profit business entities mentioned in the Inflation Reduction Bill…

In the bill, it is stated that as of 2024, premium increases for Medicare Part D & Advantage will be limited to be in align with CPI/COLA – be prepared to see substantial increases in premiums starting Jan 2023

The act limited  out of pocket expenses to $2,000/yr  – be prepared to see a substantial increases in deductibles…  These deductibles a few years ago went from ZERO to close to $500/yr already…

Could we see $2000/yr deductibles starting in 2025, and whoever is sworn in as President Jan 2025 get the blame..?

Could we see 50%-100% increase in premiums for 2023 so pad premiums for premiums increases locked into CPI/COLA starting in 2024 ?

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Missouri, Kansas hospital leaders fear a ‘healthcare crisis’ is coming

Posted on August 28, 2022 by Pharmaciststeve

Missouri, Kansas hospital leaders fear a ‘healthcare crisis’ is coming

https://www.beckershospitalreview.com/patient-safety-outcomes/missouri-kansas-hospital-leaders-fear-a-healthcare-crisis-is-coming.html

As flocks of nurses are leaving hospitals and health systems struggle to return to normal bed space, some healthcare executives in the Midwest worry they aren’t prepared for the fall and winter.

Recent data isn’t lining up with seasonal trends, according to Richard Watson, MD, a co-founder of an app that tracks Kansas hospital transfers. 

“These are not COVID beds that we’re needing right now,” Dr. Watson told KCUR. “We need beds across the board. The system is already at a higher level of capacity than it was even last year as we went into this time period. Without a doubt, even without any of the other surges, we’re going into the fall in a precarious position.”

So far in 2022, healthcare turnover reached an all-time high at 24.7 percent, according to the Missouri Hospital Association. In Kansas, the healthcare worker turnover rate was 19 percent and the vacancy rate was 16 percent, the Kansas Hospital Association reported in January. 

The shortage of space at Wichita, Kan.-based Ascension Via Christi St. Joseph resulted in more violence against its employees, the hospital’s president told the Kansas Reflector.

“It is not so much a COVID crisis as it is a healthcare crisis,” Steven Stites, MD, chief medical officer of the University of Kansas Health System, told KCUR. “Many hospitals are going to be faced with financial shortfalls and may close. We’re at a little bit of a precarious tipping point right now in healthcare.”

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Will Drug Prices Actually Fall?

Posted on August 27, 2022 by Pharmaciststeve

Will Drug Prices Actually Fall?

Will Drug Prices Actually Fall?

https://www.daily-remedy.com/will-drug-prices-actually-fall/

Sometimes we think we solved something, when we merely changed the game.

President Biden’s signature healthcare legislation, the Drug Pricing Plan, which was previously rolled into various versions of the Build Back Better Plan and now the Inflation Reduction Act, has finally passed both houses of Congress and signed into law.

Now Medicare can apparently negotiate the price of drugs.

“It’s a huge deal,” says Stacie Dusetzina, professor of health policy at Vanderbilt University. “It really does break a lot of new ground and fix a lot of problems.”

It has been proclaimed as the savior of healthcare, echoing sentiment similar to the passing of the Affordable Care Act, or Obama care. But such exuberance might be premature. Or, as Stacie Dusetzina says moments later: “It is a modest start.”

To understand why we should approach the law with a bit of caution, we must begin with the concept of price in healthcare. Many were shocked to hear the government cannot directly negotiate drug prices. But that is only partially true. The government has always influenced price, just not in the direct way we see in other industries.

Previously, drug prices were set by drug manufacturers and pharmacy benefit managers and, to a lesser extent, the pharmacies themselves. The federal government, namely the health policy makers leading different health administrations, was forbidden from interfering in drug prices because of an aptly titled clause, “noninterference”.

It stipulates the Department of Health and Human Services, which oversees the Food and Drug Administrative and the Centers for Medicare and Medicaid Services, “may not interfere with the negotiations between drug manufacturers and pharmacies and PDP [prescription drug plan] sponsors, and may not require a particular formulary or institute a price structure for the reimbursement of drugs.”

Libertarians would argue in favor of this model. After all, it suggests that the market dynamics of the supply chain set drug prices. Manufacturers sell to distributors who sell to retailers, and whoever has the most influence in the supply chain sets the price. But in the pharmaceutical industry, market conditions do not influence supply chains. Patents do. And that makes all the difference.

Patent protection allows drug manufacturers to limit the competition and produce drugs for a minimum of ten years. It also limits the ability of those down the supply chain to affect drug prices, including the pharmaceutical distributors and insurance carriers.

Take such protections away and you would have lower drug prices because conceivably, you will have more competition – or so the politicians would have us believe. But market protections in the pharmaceutical industry go beyond patent protections, or the cost of innovation. They are set by manufacturing licenses, distribution rights, and other means of bureaucratic control set through the pretense of regulatory oversight.

In short, market forces do not set drug prices. They are offset by entities with undue market influence that engage in shared profiteering under the guise of cost sharing. Just look at the profit margins enjoyed by pharmaceutical manufacturers and distributors compared to healthcare providers. When a pharmaceutical company offers rebates to patients, it appears to be providing discounts. But the rebates come with strings attached, such as giving the company exclusive distribution rights.

So while it appears the pharmaceutical company is minimizing out-of-pocket expenses for patients, it is actually increasing profits by preventing market competition.

The law will not change this dynamic because no one in positions of power wants to stop the gravy train of drug discovery. There is too much money in innovation. And whatever concessions are made in lowering the drug prices will be compensated for somewhere else.

This much becomes apparent when we look at the law itself. It reads more like a hedge fund investment strategy that uses derivatives to set price changes. In the law, Medicare does not actually control drug prices directly, as some reports would have you believe. Instead, it exerts an influence over the average price of select drugs and its rate of increase.

Specifically, the ones with limited generic or biosimilar competitors that are already exorbitantly priced. The law explicitly says: only the fifty drugs with the highest Medicare spending would be eligible. Those exempt would be drugs under patent protection and those that serve small markets comprising less than 1 percent of the Medicare annual spend or those that treat rare diseases.

The law also places upper and lower bounds on drug prices and the extent to which those prices can change. It is advertised as a way to prevent drug prices from increasing faster than inflation, though it will more likely be used to prevent drug prices from decreasing too quickly.

It all reads like financial speculation, more than actual legislation, which may be the point. The pharmaceutical industry knows how to reap a profit, and this law will do little to curtail that trend. True, the advertised cost of drugs will be lower, but drug makers will simply shift how they cost share to keep drug prices within the defined parameters, while reaping additional revenue elsewhere.

The law is rife with moral hazards. Even those criticizing it do not understand how easily the law can be manipulated. Some have claimed we will see fewer drugs once we enact it. This is partially true. Drug innovation will continue. But we will see fewer drugs – available to all patients.

With fewer rebate mechanisms available and tighter restrictions on the upper limits of drug prices, we will see fewer drugs for those unable to pay out-of-pocket expenses, as well as lower out-of-pocket expenses for those who have always been able to pay. The law will exemplify how implicit moral hazards create health disparity. The have’s will continue to have and the have-not’s will continue to have not.

But the profiteering will not stop. Though profiteering was never the problem. It was finding a fair solution to drug costs, one that shares costs across the supply chain and among all patient populations.

Instead, we bounded and capped drug prices to restrict the cost sharing of drug prices and limit drugs to a limited part of the patient population.

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Omicron Boosters Are Coming, But They Weren’t Tested on People. Here’s What You Need to Know

Posted on August 27, 2022 by Pharmaciststeve

Omicron Boosters Are Coming, But They Weren’t Tested on People. Here’s What You Need to Know

https://news.yahoo.com/omicron-boosters-coming-weren-t-141554424.html

With nearly all the new COVID-19 infections in the U.S. coming from the Omicron BA.4 and BA.5 subvariants, it makes sense that health officials are considering switching to a different vaccine to protect the public.

White House COVID-19 response coordinator Dr. Ashish Jha expects the first Omicron-specific booster to be available in mid-September at the earliest, if the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) authorize and recommend the shot. In late August, both Pfizer-BioNTech and Moderna submitted requests to the FDA for authorization of their Omicron-specific boosters.

But with the fall and winter fast approaching—the seasons when respiratory viruses like SARS-CoV-2 spread even more efficiently, as students return to school and people huddle indoors—getting the booster ready requires a more efficient review and regulatory process. And that includes considering safety and efficacy data from animals, not people.

Back in June, the FDA’s panel of independent vaccine experts met to consider switching the country to a new booster that targets Omicron, given how quickly that variant is dominating new infections. At the time, the two largest COVID-19 vaccine makers, Pfizer-BioNTech and Moderna—which both make mRNA-based vaccines—had developed shots against an earlier Omicron variant, BA.1. The panel decided that if health authorities were going to change the booster shot to target Omicron, the next one should protect against the BA.4 and BA.5 subvariants, which would continue to account for almost all cases in the winter season.

They asked the vaccine manufacturers to develop a new vaccine, one that combined the original vaccine and also targeted Omicron BA.4 and BA.5. At the end of August, both companies submitted data on their new, bivalent vaccines to the FDA for emergency use authorization.

Given the short time they had to develop the shot, however, the data only included information on the safety and efficacy of the booster in animals.

Human studies are planned and will be ongoing even if the FDA and CDC decide to authorize the shots and the government starts distributing them.

The FDA has also decided to review the animal study data without consulting its advisory committee again.

That has vaccine experts divided. Dr. Paul Offit, a member of the advisory committee, says this strategy makes him “uncomfortable” for several reasons. He notes that the data presented from Pfizer-BioNTech and Moderna in June involving their BA.1 booster shot, which focused on the levels of virus-fighting antibodies the vaccine generated, were underwhelming. “They showed that the neutralizing antibody titers were between 1.5- and two-fold greater against Omicron than levels induced by a booster of the ancestral vaccine,” he says. “I’d like to see clear evidence of dramatic increase in neutralizing antibodies, more dramatic than what we saw against BA.1, before launching a new product. We’re owed at least that.”

While conducting human studies does take more time, Offit says even a small trial involving about 100 people to measure their antibody levels after getting a BA.4/5 booster would be helpful. “You can boost people and measure their neutralizing antibodies two weeks later,” he says. Such information could also be critical in setting realistic expectations for the Omicron booster. The public might feel it’s a panacea that signals the end of the pandemic, but without any data showing how well the booster will protect people from not only getting sick, there might be unrealistic expectations about what the boost can do. “I get a little nervous, frankly, when I hear this [booster] is going to be miraculous,” Offit says.

Other experts see it a little differently. Based on the fact that the mRNA vaccines have been administered to millions of people so far, with relatively few safety concerns, and given that the vaccines have been effective in protecting people from getting hospitalized or dying of COVID-19, even during the latest Omicron surges, they argue that changing the strain of virus in the vaccine doesn’t require the same extensive testing that the original shot did. “The totality of evidence is relevant here,” says Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital, and also a member of the FDA’s vaccine advisory committee. “We are in a situation where we need to pivot as variants emerge, and if we try to be too rigid in our approach, we will always be behind, and not giving the population optimal protection.”

Levy says that the latest Omicron-specific boosters that the FDA is considering contain a combination of mRNA targets against both the original virus and Omicron BA.4/BA.5, so the data on safety and efficacy from the original vaccine in protecting against hospitalization and death is relevant. While the data on this vaccine does come from animals, using that data to decide whether or not to authorize the booster is a matter of “hedging bets.” There is data showing that even vaccinated and boosted people can get mild to moderate COVID-19 disease, because their vaccine-induced protection is waning, so boosting with a shot that is better matched to the Omicron subvariants circulating now is a reasonable bet, even if the data on its efficacy comes from animals and not people. “I think it’s the right decision,” says Levy.

There’s no guarantee that the FDA will authorize the new bivalent vaccines, although all signs point to an authorization that could come in a week or so. If the shots are released and people get boosted, health officials will be carefully monitoring data from those vaccinees to ensure that the assumptions they made about the safety and efficacy of the booster hold. And hospitalization rates in the coming winter will reveal whether betting on the new Omicron-specific booster was the right decision.

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WHIO ‘Tranq Dope’ is a powerful new, potentially deadly drug raising alarms locally

Posted on August 27, 2022 by Pharmaciststeve

seems like the “street drug dealers” and the drug cartels … are bringing out more “new drugs” that the brand name pharmas do..  but.. then I suspect that the street dealers and the cartels are doing any clinical trials about safety and appropriate dosing 🙁  This new “street drug” may spread faster than the first version of COVID-19

‘Tranq Dope’ is a powerful new, potentially deadly drug raising alarms locally

https://sports.yahoo.com/tranq-dope-powerful-potentially-deadly-232715058.html

A new drug called “Tranq Dope” is raising alarms in the Miami Valley because it is a combination of opioids and a drug used to sedate animals.

“We don’t expect it to be too long before it comes right up I-75 into the Miami Valley,” Charles Patterson, health commissioner, Clark County Combined Health District, told News Center 7′s Kayla McDermott on Friday.

There have already been 18 deaths from opioid use in Clark County this year, and Patterson said he fears the count will increase with a new drug entering the market.

Xylazine is the main drug used in Tranq Dope, most commonly found in veterinarian’s offices as a tranquilizer for animals.

“It’s a sedative, a muscle relaxer for animals, such as cattle,” Wendy Doolittle, CEO at McKinley Hall Inc. addiction center in Springfield. “So, it’s not approved for any human consumption.”

Patterson said the Xylazine has been watered down and spread as a similar to heroin type of drug.

When mixed with either opioids or fentanyl, the combination can be lethal.

Doolittle issued an ominous announcement: “I think we are about to see our death rate increase as a result of this being on the streets.”

Counties in Ohio are beginning to test overdose victims for the drug. If you’re trying to find a detox center in Portland, check them out now.

In Hamilton County, the coroner’s office reports that 15 overdose victims that have tested positive for Xylazine in their systems.

Patterson said the Hamilton County Coroner’s Office has registered those deaths and has been able to perform screens for toxins in the blood.

Narcan won’t reverse the effects, Doolittle said, and those who survive using the drug are left with skin that starts to turn black at the injection site and then the skin starts to deteriorate, to break down. And it literally looks like just black decayed skin that continues to just kind of grow and peel could result in amputations.

Tranq Dope is so new the Ohio Department of Health still has several questions they want answered, such as whether the drug is the same from state to state in terms of composition and how much tranquilizer is in each dose.

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DONALD HYUNGJOON KIM, MD., “VICTORY,” UNITED STATES MOTION DISMISSED INDICTMENT, 9-0 SUPREME COURT RULING IN RUAN-KHAN

Posted on August 25, 2022 by Pharmaciststeve

DONALD HYUNGJOON KIM, MD., “VICTORY,” UNITED STATES MOTION DISMISSED INDICTMENT, 9-0 SUPREME COURT RULING IN RUAN-KHAN

https://youarewithinthenorms.com/2022/08/25/donald-hyungjoon-kim-md-victory-united-states-motion-dismissed-indictment-9-0-supreme-court-ruling-in-ruan-khan/

You’re Within The Norms

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

REPORTED 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”

UNITED STATES MOTION DISMISSED INDICTMENT BASED ON 9-0 SUPREME COURT RULING IN RUAN-KHAN

DONALD HYUNGJOON KIM, MD.

UNITED STATES’ MOTION TO DISMISS INDICTMENT

The United States of America, pursuant to Federal Rule of Criminal Procedure Rule 48(a), respectfully moves this Court to dismiss the Indictment, returned June 17, 2020, in the above-styled case without prejudice. Such action would best meet the ends of justice for the following reasons:

(OBJECTIVE STANDARDS)

1. On June 17, 2020, a federal grand jury issued an Indictment charging Defendant Donald Hyungjoon Kim, M.D. with 154 counts of distributing controlled substances outside the usual course of medical practice and without medical necessity to include 3 counts of distribution with death resulting. (Doc. 1.)

MUST PROVE BEYOND THE REASONABLE DOUBT

2. On June 27, 2022, the Supreme Court issued its opinion in Ruan v. United States, — U.S. —-, 142 S.Ct. 2370 (2022). In Ruan, the Supreme Court held that the government must “prov[e] that a defendant knew or intended that his or her conduct was unauthorized,” which inserted a mens rea requirement that had not previously been recognized. Id. at 2382; see United States v. Khan, 989 F.3d 806, 825 (10th Cir. 2021),

Case 5:20-cr-00163-PRW Document 53 Filed 07/29/22 Page 2 of 3

W.D.Okla_._5_20-cr-00163-PRW_53_0-1Download

vacated and remanded by Ruan, 142 S.Ct. 2370 (holding that “§841(a)(1) and § 1306.04(a) require the government to provide that a practitioner-defendant either: (1) subjectively knew a prescription was issued not for a legitimate medical purpose; or (2) issued a prescription that was objectively not in the usual course of professional practice”).

INDICTMENT WAS DEFECTIVE

3. Based on this intervening Supreme Court ruling, the United States has concluded that the Indictment is defective. As such, the government believes that the ends of justice would best be served by dismissing, without prejudice, the Indictment in this case.

WHEREFORE, the United States requests that this Court enter an Order dismissing, without prejudice, the Indictment filed herein on June 17, 2020.

Respectfully submitted,

ROBERT J. TROESTER United States Attorney

Harvey Silverglate

Mr. Silverglate, a Boston criminal-defense and civil-liberties litigator, is the author of “Three Felonies a Day: How the Feds Target the Innocent” (Encounter, second edition 2011).

June 12, 2015, 6:42 pm ET

WHEN TREATING PAIN BRINGS A CRIMINAL INDICTMENT

” Federal drug-enforcement officials have made it a serious felony for doctors to overprescribe painkillers or, as the applicable law states, to prescribe controlled substances “other than for a legitimate medical purpose and in the usual course of professional practice.”

But the line between legitimate and illegitimate prescription—as drawn by the Drug Enforcement Administration (DEA) and the Justice Department—is far from clear. This puts physicians in great legal jeopardy and too often leaves their patients to suffer needless agony.

The Hidden mantra of the DOJ and DEA

“The atmosphere around prescribing for chronic pain had become so fraught that physicians felt they must avoid opioid analgesics even in cases when it contradicted their view of what would provide the best care for their patients.

In some cases, this desire to reduce opioid prescribing translated to doctors tapering patients off their medications without patient consent. In other words, it meant that physicians would no longer accept patients who had a history of needing high-dose opioids.”

CONSTITUTIONAL CULTURAL ART GALLERY JOHANNESBURG, SOUTH AFRICA

THE STRUGGLE

THE RULE OF LAW

The Rule of law is the most fundamental concept of our country without it our society crumbles which then allows for an agency to take anything they want unchecked based on their own manufactured rules and misinterpretation of laws, medical procedures guidelines. Thus creating their own science and facts.

In healthcare the great fear at the moment is the DEA operates unchecked as a rogue sub agency of government operating outside the rule of law  creating their medical science.

ANALYSIS

Ruan provides: “ A strong scienter requirement helps reduce the risk of “over-deterrence,” i.e., punishing conduct that lies close to, but on the permissible side of, the criminal line.” An objective standard of care was not proven. The indictment used the improper evidentiary standard.”

 

THE JOURNEY

“AND IT SHALL BE CALLED YOUAREWITHINTHENORMS”

“AND IT SHALL BE CALLED YOUAREWITHINTHENORMS”

FOR NOW, YOU ARE WITHIN

YOUAREWITHINTHENORMS.COM,(WYNTON MARSALIS CONCERTO FOR TRUMPET AND 2 OBOES, 1984)

THE NORMS

 

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NYC: Democratic Primary Winner Declares Victory For ‘Socialism’

Posted on August 25, 2022 by Pharmaciststeve

If this is representative of the USA’S potential future ?… for some reason… makes me not unhappy for being near the end of my life expectancy. Is it just me, but is this another female from New York city and looks/sounds like AOC ?

Because of the 2020 Census – 7 states gained House members and 7 states lost House members..  A member of the House represents about 700,000 constituents in their state. So during the 2010-2020 period abt FIVE MILLION of our citizens shifted the states they live in and from the graphic below – TEXAS was the biggest winner. California – for the first time EVER – lost a seat in the House, because of  MORE PEOPLE MOVING OUT THAN MOVING IN.

I have a concern that “socialism” will lead to some sort of universal health insurance and if we follow Canada’s lead … here is a recent article about the state of Canada’s healthcare system Euthanasia Is Now A Leading Cause Of Death In Canada, And Ethicists Are Freaking Out   and guess who may be first on THE LIST,  the high acuity – sickest of the sick and the ones that are consuming the most healthcare $$$ ?

Which States Won — And Lost — Seats In The 2020 Census?

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