CDC sued for vaccine safety app data after multiple refusals

CDC sued for vaccine safety app data after multiple refusals

https://www.foxnews.com/politics/cdc-lawsuit-vaccine-data

A nonprofit that is critical of vaccines is suing the Centers for Disease Control and Prevention (CDC) after the agency declined to comply with a Freedom of Information Act (FOIA) request for data on the effects of the coronavirus vaccine.

Announced Thursday, the lawsuit surrounds data from the “V-Safe” system used by the CDC to track patients’ health after receiving the coronavirus vaccination. The group says the CDC has already provided Oracle, a government contractor, with the data in a deidentified form – or lacking personal information.

The CDC also tracks safety through its Vaccine Adverse Event Reporting System (VAERS) and continues to say that the approved and authorized COVID-19 vaccines are safe and effective.

“V-safe data will be collected, managed, and housed on a secure server by Oracle,” according to a CDC document.

Attorney Aaron Siri, who represents the Informed Consent Action Network (ICAN), said that the CDC initially refused to provide app data because it purportedly wasn’t “deidentified” or stripped of personal information. When ICAN followed with a request for “all data submitted to v-safe and subsequently deidentified,” the CDC rejected the request as duplicative of the original.

Lurie Children’s hospital registered nurse Carolyn Ruyle prepares a dose of a Pfizer COVID-19 vaccine at Lurie Children’s hospital Friday, Nov. 5, 2021, in Chicago. (AP Photo/Nam Y. Huh)

“If this sounds ridiculous, it is because it is,” said Siri. “The public should be outraged by the CDC’s games.” 

ICAN’s lawsuit notes that the CDC said V-Safe was part of “the most intensive vaccine safety monitoring effort in U.S. history.”

Department Of Health and Human Services, Hubert H. Humphrey Building on April 11, 2015, in Washington.  (Raymond Boyd/Getty Images)

Siri, on behalf of another group, previously sued the Food and Drug Administration (FDA) for more than 400,000 pages of information on the approval process for Pfizer-BioNTech‘s COVID-19 vaccine. The FDA had offered to release 12,000 documents by January and a minimum of 500 pages a month, which could mean it would be decades before all the documents would become public.

The CDC and Oracle did not immediately respond to Fox News’ request for comment.

“The federal government is thereby not only failing to provide the transparency necessary to earn the American people’s trust regarding these vaccines but is also failing to comply with FOIA,” the lawsuit reads.

One of the two drugs in the antiviral cocktail could cause serious interactions with widely used prescriptions, including statins, blood thinners and some antidepressants

Pfizer antiviral pills may be risky with other medications

https://www.nbcnews.com/health/health-news/pfizer-covid-pills-covid-symptoms-may-risky-drugs-rcna9683

As the omicron surge pummels a pandemic-weary nation, the first antiviral pills for Covid-19 promise desperately needed protection for people at risk of severe disease. However, many people prescribed Pfizer’s or Merck’s new medications will require careful monitoring by doctors and pharmacists, and the antivirals may not be safe for everyone, experts caution.

Paxlovid, Pfizer's Covid-19 pill, is manufactured in Ascoli, Italy.
Paxlovid, Pfizer’s Covid-19 pill, is manufactured in Ascoli, Italy.Pfizer via Reuters

The Food and Drug Administration authorized Pfizer’s Paxlovid for mild to moderate Covid in people as young as 12 who have underlying conditions that raise the risk of hospitalization and death from the coronavirus, such as heart disease or diabetes. However, one of the two drugs in the antiviral cocktail could cause severe or life-threatening interactions with widely used medications, including statins, blood thinners and some antidepressants. And the FDA does not recommend Paxlovid for people with severe kidney or liver disease.

Because of experts’ concerns about the potential side effects of Merck’s molnupiravir, the FDA has restricted its use to adults and only in scenarios in which other authorized treatments, including monoclonal antibodies, are inaccessible or are not “clinically appropriate.”

The Paxlovid cocktail consists of two tablets of the antiviral nirmatrelvir and one tablet of ritonavir, a drug that has long been used as what is known as a boosting agent in HIV regimens. Ritonavir suppresses a key liver enzyme called CYP3A, which metabolizes many medications, including nirmatrelvir. In the case of Paxlovid treatment, ritonavir slows the body’s breakdown of the active antiviral and helps it remain at a therapeutic level for longer.

The boosting effect was likely to have been crucial in driving Paxlovid’s high effectiveness in clinical trials.

When Paxlovid is paired with other medications that are also metabolized by the CYP3A enzyme, the chief worry is that the ritonavir component may boost the co-administered drugs to toxic levels.

Complicating matters, the drugs that pose interaction risks are widely prescribed to people at the greatest risk from Covid because of other health conditions.

The medications include, but are not limited to: blood thinners; anti-seizure medications; drugs for irregular heart rhythms, high blood pressure and high cholesterol; antidepressants and anti-anxiety medications; immunosuppressants; steroids (including inhalers); HIV treatments; and erectile dysfunction medications.

“Some of these potential interactions are not trivial, and some pairings have to be avoided altogether,” said Peter Anderson, a professor of pharmaceutical sciences at the University of Colorado Anschutz Medical Campus. “Some are probably easily managed. But some we’re going to have to be very careful about.”

Pfizer Covid pills may be risky with other medications

In its fact sheet about Paxlovid, the FDA has published a detailed list of medications that may interact harmfully with ritonavir, including those that should not be paired with the Covid antivirals.

However, pharmacists stress that many of the drug interactions are manageable and that they should not preclude most people from taking Paxlovid.

“Pharmacists are highly trained experts in medication safety and monitoring and are an excellent source of information and advice about interactions between medications and also supplements and herbal products,” said Emily Zadvorny, a clinical pharmacist who is the executive director of the Colorado Pharmacists Society. “They will help determine if a significant interaction exists and devise solutions to mitigate the interaction if possible.” 

‘A breakthrough drug’

The good news is that health care providers have experience navigating ritonavir’s use among people with HIV — a group that often takes medications for other health conditions, in addition to antiretroviral therapy.

Dr. William Werbel, an assistant professor of medicine at Johns Hopkins University who specializes in transplant infectious diseases, advised people at high risk of Covid-19 complications to talk to their health care providers, as well as a savvy pharmacist, about changes they could make to their drug regimens should they need Paxlovid — even before they become infected with the virus.

Anyone seeking Paxlovid, which must be prescribed within five days of the first symptoms, should be sure to let their prescribers and pharmacists know the complete lists of other medications and over-the-counter supplements they are taking, Anderson said.

Some medications, such as particular statins, are most likely safe to stop taking during treatment with the Covid pills, Anderson said. For example, it might be better to stay on certain blood thinners but to lower the doses. Some heart rhythm drugs cannot be taken with Paxlovid.

Conversely, some anti-seizure medications can boost liver enzymes’ metabolic action and thus lower the body’s Paxlovid levels, as can the herbal supplement St. John’s Wort. The FDA warned that they should not be combined with Paxlovid.

Because the Paxlovid treatment is brief — 30 pills, taken as three pills twice a day for five days — experts are hopeful that the risk of adverse interactions with other medications is low.

“Five days of interactions is not a big deal for the majority of drugs,” said Jason Gallagher, a clinical pharmacy specialist in infectious diseases at Temple University Hospital in Philadelphia.

If a drug’s potential interaction with Paxlovid poses too much of a risk, Anderson said, a safe and effective alternative Covid-19 therapy would be GlaxoSmithKline’s sotrovimab — the sole authorized monoclonal antibody treatment that research indicates reliably neutralizes the omicron variant of the virus. Otherwise, the antiviral molnupiravir is an option, albeit one with a much lower efficacy than either Paxlovid or sotrovimab. 

Even with the concerns about taking Paxlovid with other prescription medications, experts are excited about the drug’s potential.

“Paxlovid is a breakthrough drug,” Anderson said. “This could make a real difference in the pandemic by making an effective Covid treatment available to many people.”

Quantum Leap in helping practitioners made sure that pts get the most appropriate medications

 

 

 

Individual Social Security Payment dates are changing in Jan 2022

Social Security cost-of-living boost begins: What to know

https://www.foxbusiness.com/economy/social-security-cost-of-living-boost-begins-what-to-know

Social Security recipients are set to see the highest cost-of-living increase in 40 years in 2022, a welcome boost for those depending on the fixed payments and feeling the squeeze after months of surging inflation during 2021.

The 5.9% increase is higher than has been seen in several years, as cost-of-living adjustments are made in line with the Department of Labor’s Consumer Price Index. This is the largest COLA rise since 1982, when recipients received a 7.4% cost-of-living adjustment.

A sign is seen outside a US Social Security Administration building, November 5, 2020, in Burbank, California.  (Photo by VALERIE MACON/AFP via Getty Images / Getty Images)

In announcing the COLA in October, the Social Security Administration said the average retiree will see a monthly increase in their payment of $92, bringing the average check amount to $1,657. The typical couple would see their benefits jump $154 to $2,754.

The SSA has since released a calendar showing when the roughly 70 million beneficiaries can expect to receive their payments starting in January.

For those with a birth date between the first and tenth of the month, they can expect their payments on the second Wednesday of the month.

 A Social Security card sits alongside checks from the U.S. Treasury on October 14, 2021 in Washington, DC. (Photo illustration by Kevin Dietsch/Getty Images / Getty Images)

Beneficiaries with birthdays on the 11th through 20th will receive payments on the third Wednesday of the month, and those with birth dates on the 21st through the 31st will get their checks or deposits on the fourth Wednesday of the month.

While the social security payment amount increase will no doubt provide relief to many recipients, it could also accelerate the depletion of the fund sooner than expected – and might not cover the rising costs seniors truly face as inflation continues to rise for everything from consumer goods to gasoline to housing.

The Committee for a Responsible Federal Budget estimates that the Social Security payment increase for 2022 means the fund will be unable to pay full benefits by 2032, a full year earlier than projected.

A visitor sits near the U.S. Capitol building in Washington, D.C., U.S., on Saturday, Dec. 18, 2021. (Photographer: Samuel Corum/Bloomberg via Getty Images / Getty Images)

Meanwhile, the national debt sits at around $29,000,000,000,000 ($29 trillion), and the federal deficit is at roughly $3 trillion for fiscal year 2021 according to the Congressional Budget Office. 

DEA raid of pharmacy: first thing – DISABLED PHARMACY SECURITY CAMERA SYSTEM

THE GRAND OPIOID HOAX: MATTER BEFORE THE UNITED STATES SUPREME COURT, “THE ROLE OF PHARMACY” BRIEFS NATIONAL ASSOCIATION OF CHAIN DRUG (NACDS)STORES/ NATIONAL ASSOCIATION OF CRIMINAL DEFENSE LAWYERS(NACDL)

https://youarewithinthenorms.com/2021/12/30/john-beerbower-esq-deas-diversion-supervisor-susan-langton-the-handlers-vs-pronto-pharmacy-llc-part-3a/

DONATE LEGAL DEFENSE

BY

NORMAN J CLEMENT RPH., DDS, NORMAN L.CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, ESTHER HYATT PH.D., IN THE SPIRIT OF JOSEPH SOLVO ESQ., in the spirit of REV. C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., MBA., IN THE SPIRIT OF PATRICIE LUMUMBA, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, SHELLEY HIGHTOWER, BS., PHARMD.,  LEROY BAYLOR, BEVERLY C. PRINCE FACS, MD., ADRIENNE EDMUNDSON, NATASHA DUVALL PHARMD., WALTER L. SMITH BS., LEROY BAYLOR, BS., MS., MS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS

 

This series of articles further demands the return of Control Substance Registration of Pronto Pharmacy, At Cost Pharmacy, Gulf Med Pharmacy and for restoration and compensation Black-owned Pharmacy who have been targeted by the Corruption of the United States Drug Enforcement Agency

BRIEF PARTIAL


Mary Mihal@mazsamem replying to @urwithinthenorm

“Lack of effective pain relief is harming millions of Americans. Racial bias exists in the health care field–it’s rampant. Kolodny is considered an expert. I hope the future sees him for what he is because the present values his killer instincts. War on Drugs is a war on people.“

THIS PRESENTATION IS A VIDEOS NARRATIVE SUPPORTING THE FOUNDATION OF THIS ARTICLE

This article enjoins Physicians, Nurse Practitioners, Dentist, both Pharmacies and Pharmacists, to similar related arguments presented before:

The United States Supreme Court No. 20-1410 in XiUlu Ruan, MD vs. United States of America (DOJ-DEA) and U.S. DRUG ENFORCEMENT ADMINISTRATION; ACTING ADMINISTRATOR TIMOTHY J. SHEA; U.S. DEPARTMENT OF JUSTICE; ATTORNEY GENERAL WILLIAM P. BARR Civil Action No. 4:20-cv-00817-SDJ, in which Brief were entered on behalf of Walmart Pharmacy in the UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF TEXAS SHERMAN DIVISION

BACKGROUND

On August 29, 2019, DEA agents raided Pronto Pharmacy, Tampa, Florida. They entered the premises under the authority of a search warrant based on a false narrative prescription being filled was illegal.

There were numerous deficiencies in the warrant, which questions the veracity of the contents which supported or the lack of documentation to support Probable Cause. The DEA Diversion Investigator admitted in court testimony he did not investigate patients’ treatment records, interviewed No prescriber, and fail to send any prescription to his Pharmacist expert.

Upon entry, the very first thing the raiding party performed was to disable building surveillance camera systems(see surveillance video 08/29/2019).

DEA AGENT ILLEGALLY DESTROYING PRONTO PHARMACY, TAMPA FL., SECURITY CAMERA SYSTEM DURING RAID (08-29-2019), THIS VIDEO IS THE ONE THE UNITED STATES JUSTICE DEPARTMENT CALLED ATTORNEY DALE SISCO AND WANTED IT TO BE REMOVED FROM YWTN BLOG. THE DEA AND DOJ ARE NOT GETTING AWAY WITH THIS CORRUPTION IF ONE DOESN’T FIGHT BACK THEN ONE CAN’T EXPECT TO WIN WHEN ONE FIGHTS WITH DETERMINATION, TO WIN, THAT CHANGES THE RULE OF THE BALL GAME THEN GOD WILL HELP YOU TO ACCOMPLISH YOUR GOALS

THE NATIONAL ASSOCIATION OF CHAIN DRUG STORES

The National Association of Chain Drug Stores (NACDS) is a leading organization supporting pharmacies in promoting and fulfilling that mission. A non-profit, tax-exempt organization incorporated in Virginia, NACDS represents traditional drug stores, community pharmacies, supermarkets, and mass merchants with pharmacies.

NACDS chain members operate over 40,000 pharmacies and employ nearly 3 million individuals, including 155,000 pharmacists; its 80 chain member companies include regional chains, with a minimum of four stores, and national companies.

FROM THE AMICUS CURIAE BRIEF OF THE NATIONAL ASSOCIATION OF CHAIN DRUG STORES IN SUPPORT OF NEITHER PARTY:

“The CSA recognizes pharmacists’ circumscribed role in dispensing controlled substances. It provides that pharmacists may not dispense Schedule II controlled substances “without the written prescription of a practitioner,” 21 U.S.C. § 829(a) and that they risk criminal and civil liability if they do, see id. §§ 841(a), (c), 842.

The CSA’s implementing regulations further explain that a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a). The regulations separately provide that such a prescription “may only be filled by a pharmacist, acting in the usual course of his professional practice and either registered individually or employed” by a registered entity. 21 C.F.R. § 1306.06.

Although § 1306.04(a) regulates both prescribers and pharmacists, the two roles are far from interchangeable, including for purposes of determining potential liability. With different licenses, education, skill sets, responsibilities, and workplaces from physicians, pharmacists play a vital but distinct role in a patient’s care.

Specifically, when dispensing a controlled substance to a patient, as prescribed by a physician, a pharmacist relies on the physician’s assessment of the patient’s needs.

The pharmacist has neither examined nor diagnosed the patient, and lacks the information the physician has collected on the patient’s medical situation, records, and history, including such things as x-rays, ultrasounds, lab results, and treatment plans.”

In resolving the issues presented in these cases— including whether a good-faith defense is available to a practitioner charged with violating 21 U.S.C. § 841(a)—the Court should take care not to weaken the knowledge requirement in § 1306.04, insofar as it applies to pharmacists. That requirement is a critical safeguard against unwarranted liability, which could unduly chill pharmacists from performing duties vitally important to public health.”

THE NATIONAL ASSOCIATION OF CRIMINAL DEFENSE LAWYER

The National Association of Criminal Defense Lawyers is a nonprofit, voluntary professional bar association that works on behalf of criminal defense attorneys to ensure justice and due process for those accused of crime or misconduct. Founded in 1958, NACDL has a nationwide membership of many thousands of direct members and about 40,000 total members with affiliates.

THE NATIONAL ASSOCIATION OF CRIMINAL DEFENSE LAWYERS

Consistent with its mission of advancing the proper, efficient, and fair administration of justice, NACDL files several amicus briefs each year in the United States Supreme Court and other state and federal courts, all aimed at assisting in cases that present issues of broad importance to criminal defendants, criminal defense lawyers, and the criminal justice system as a whole.

DONATE LEGAL DEFENSE

SUMMARY OF ARGUMENT

From the Amicus Curiae Brief filed December 27, 2021, by NACDL in Xiulu Ruan MD, Shakeel Kahn MD, Petitioners vs. United States of America, Respondent before the United Supreme Court Case No: 20-1410:

“Our country continues to struggle with widespread overdoses and deaths caused by the rampant abuse of opioids. To combat this ongoing crisis, the federal government aggressively has prosecuted doctors and medical professionals alleged to have illegally diverted addictive pills into the black market. A common narrative in these cases is that doctors have fueled the crisis by overprescribing controlled substances as a violation of federal criminal law.

Of course, some doctors have prescribed opioids to patients for illegal reasons. Yet, many other doctors have issued well-intentioned prescriptions to treat patients for a variety of pain syndromes consistent with governing standards of professional care. Criminal liability depends on the scienter. No court should interpret federal law to impose criminal penalties when a defendant’s doctor has acted in good faith and the government has not demonstrated the specific mental state that Congress has required.

NATIONAL ASSOCIATION OF CRIMINAL DEFENSE LAWYERS

The Controlled Substances Act imposes no criminal liability on doctors for lawfully prescribing controlled substances in the normal course of treating patients. That should come as no surprise. Society benefits when doctors prescribe drugs for legitimate medical purposes authorized by the Act.

Criminal liability attaches only when defendant doctors knowingly prescribe controlled substances to patients in circumstances not authorized by Congress. Consequently, the government must demonstrate that a defendant doctor knowingly prescribed drugs in illegal circumstances. When the government alleges that a doctor has violated of 21 U.S.C. § 841, lower courts have erred in concluding that a doctor’s good faith is not relevant to criminal liability.”

DEA ATTORNEY JOHN BEERBOWER

JOHN BEERBOWER Esq (5)

AND

THE FOUNDATION OF CORRUPTION AND CRIMINALITY

” The Government attacks your ability to generate income until you succumb their criminal activity

WAGING A WAR OF AGGRESSION ON MEDICAL SCIENCE “

 

John Beerbower Esq is a United States Attorney for the DEA his activities are the center of deception and corruption within the Justice Department which are both profound as well as unconstitutional requiring Congressional Oversight and investigation.

Mr. Beerbower operates with a unique judicial court system that acts as both Civil or Criminal and abides by no Federal Rules of Criminal and Civil Rules of procedures.

John Beerbower’s power to operate powers comes solely from this court which operates outside Federal Civil rule and further acts as a Federal Criminal court without six amendment protection and a Civil Court without fourth amendment protections.

BRING ME THE MAN I’LL FIND THE CRIME

 

 

Yet, John Beerbowers a sworn United States Attorney supported by a small cadre of government lawyers, regional office Supervisors, Diversion Investigators, DEA Agents, and further supported by a cadre of dishonest so-called pharmacists experts who have successfully conducted a mass campaign of disinformation. Who are ingrained in their sadistic inhumanity toward the treatment of chronic pain patient care.

John Beerbower along with his cohorts Robert F. Duncan Esq, Katherine L. Steele, Esq., Paul A Dean, so-called pharmacist experts such as Don Sullivan Professor The Ohio State University.

 

DEPARTMENT OF JUSTICE

Jack Folson Amicus Brief Pronto Pharmacy LLC., 2020:

In the case of Pronto Pharmacy LLC., Mr. Beerbower:

“Presented no evidence of diversion or where any prescriptions medications control or non-control was exchanged for sale for non-medical use. Mr. Alpert was fraudulent but the DEA can sustain Alpert’s misrepresentation of both facts and through a system of corruption where Giglio rule of law does not apply and officers are free to lie and distort.”

The DEA Administrative Court is a separate judicial tribunal system that has gone unregulated and avoided the scrutiny of the Congress of the United States.

A tribunal of corruption led by corrupt Judges and supported by both corrupt United States federal prosecutors from the United States Department of Justices permitted to operate outside the rule of Federal Rules of Evidence and Procedures. ”

The corruption is as deep as it is wide and extends all to the United States Attorney General and the General offices throughout America and its territories. 

MASSIVE GOVERNMENT OVERREACH AND THE OVER-CRIMINALIZATION OF MEDICAL PROCEDURES

“WE HAVE TURNED TORT LAW INTO CRIMINAL ACTIVITY”

ARISTOCRACY oF THE SKIN

Beerbower’s role was to support DEA’s false argument to make us into narco-terrorist and criminal enterprise of Narco- dealers indict incarcerate our entire families and his premise of diversion is only deception from the truth which is the DEA wanted to close these pharmacies down.

More importantly, they started with the Black own Pharmacies because they would traditionally be the easiest enforcement target.

DEA

Mr. Beerbower surmised these pharmacies would be easy picking knowing the structure of his DEA Court would allow him to exclude most evidence in support of these targeted pharmacies’ claims that they presented no imminent danger threat to the public.

What Beerbower and his crew of white-collar DEA thugs did not anticipate is that these Black pharmacies owners would fight back. Nor did he and his crew of DOJ counterparts strewn in a history of “40-plus years of racism in one of its component law enforcement agencies, that these black pharmacies would form in a coalition to resist the implicit race biases in selective enforcement of the law.

the failure of lawmakers and

VAGUE STATUES

 Lawmakers must understand that the DEA regulates the entire legal opioid market and that if prescription opioids were fueling the crisis then the government themselves would be liable and responsible for the increase in overdose deaths.  Although prescribing of opiates has decreased in the past few years there has been a vast acceleration of overdoses proving that prescription opiates do not have a causal effect on overdoses.

NATIONAL ASSOCIATION OF CRIMINAL DEFENSE LAWYERS HEARING BEFORE HOUSE JUDICIARY COMMITTEE

Lawmakers also ignore the costs of all alternative therapies.  The high costs of physical therapy, topical medications, hypnosis, massage therapy, and behavioral modification, prohibits patients from engaging in these therapies.  Nothing is free and there is always a cost and thus many of the 8 million US citizens who currently benefit from opiate therapy cannot work or engage in a meaningful life.

When trying to regulate the private sector, federal agencies have increasingly avoided notice and comment procedures under the Administrative Procedure Act (“APA”). Rather than use the APA’s procedures—which were developed to provide regulated entities with notice and an adequate opportunity to comment before the imposition of new substantive rules of conduct— agencies increasingly issue de facto regulations in the guise of interpretive guidance.

According to the NACDL:

Overcriminalization is a dangerous trend that NACDL battles daily. With over 4,450 crimes scattered throughout the federal criminal code, and untold numbers of federal regulatory criminal provisions, our nation’s addiction to criminalization backlogs our judiciary, overflows our prisons, and forces innocent individuals to plead guilty not because they are, but because exercising their constitutional right to a trial is prohibitively expensive and too much of a risk. This inefficient and ineffective system is, of course, a tremendous taxpayer burden.

Although the harm caused by overcriminalization is frequently amplified by the executive and judicial branches, it generally originates in the legislative process. It can take many forms, but most frequently occurs through:

  • Ambiguous criminalization of conduct without meaningful definition or limitation;
  • Enacting criminal statutes lacking meaningful mens rearequirements;
  • Imposing vicarious liability with insufficient evidence of personal awareness or neglect;
  • Expanding criminal law into economic activity that is traditionally and more efficiently regulated by civil laws and civil enforcement;
  • Creating mandatory minimum sentences un-related to the severity, wrongfulness, or harm of the underlying crime;
  • Federalizing crimes traditionally reserved for state jurisdiction; and
  • Adopting duplicative and overlapping statutes.

Predicating civil liability on interpretive guidance created without a transparent regulatory process goes against the requirements of the APA and due process and, here, violates binding regulations issued by the Department of Justice (“DOJ”).

DETAINMENT PICTURE FROM NACDL WEBB SITE

The US Chamber of Commerce, Washington Legal Foundation, NRF, and RLC have an interest in seeing that agencies respect administrative law principles, stop unlawfully enforcing non-binding guidance, and operate consistently with due process and the rule of law.

The Office of National Drug Control Policy (ONDCP)

The Office of National Drug Control Policy (ONDCP) is a component of the Executive Office of the President. The mission of ONDCP is to reduce substance use disorder and its consequences by  coordinating the nation’s drug control policy through the development and oversight of the National Drug Control Strategy and Budget

It is NOT doctors or pharmacists behind the overdose deaths and both DOJ-DEA knew those facts to be true and that 100 billion dollars are spent annually on 4 illicit drugs by people in America Heroin, Cocaine, Methamphetamine, Non-Medical Fentanyl. Over 11 years 1.2 trillion dollars were spent by American consumers on these 4 illicit drugs and it was further these numbers were far greater than any number spent on diverted prescription medications.

WHAT AMERICA SPENDS ON ILLICIT DRUGS

This information was reported to ONDCP by the 2014 study from the Rand Corporation whom the White House had commissioned to conduct this study (see below video) 

J 3950

Testimony of Dr. Bruce Bagley Oklahoma Opioid Trial Day 31

The prime motivation of the DEA appears to be the false assumption that any prescribed opioid pain medication can worsen the “opioid crisis” that we now know is caused predominantly by illegal flooding of illicit Chinese fentanyl and heroin overdose deaths.  A review of statistical trends shows that this “crisis” has been present since 1970 and that the trajectory of overdose deaths was well established in numerous studies and was not affected by the entry of novel medications like OxyContin.

J2426

The Office of National Drug Control Policy (ONDCP) is a component of the Executive Office of the President. The mission of ONDCP is to reduce substance use disorder and its consequences by  coordinating the nation’s drug control policy through the development and oversight of the National Drug Control Strategy and Budget

DOJ-DEA AND THEIR RED FLAGS OF RUBBISH

RED FLAG OF RUBBISH

The DEA has set up a system of defacto-discrimination by encouraging Pharmacists to Profiling patients the Processes of “RED FAGGING.” 

Over the last several years the DOJ/DEA have introduced language to criminalize the practice of medicine the newest term is “Red Flags”. This refers to several situations or medication combinations. A combination of an opiate, a benzodiazepine, and Soma is a ” Red Flag. Going more than 15 miles to fill a prescription is another. “Red Flag “.

NO STATUTORY MEANING

The term Red Flag has no statutory meaning in the areas of pharmacy and or within the medical profession.  Those pharmacists who merely question these DEA policies risk loss of employment of administrative sanction.

The DEA can impose these errant because possess unchecked authority and weapons the ability to intimidate by seizings property and assets.  The that these DEA policies are applied so arbitrarily makes them discriminatory.

MANY PROBLEMS WITH DOJ’S “RED FLAGS

National Association of Chain Drug Stores Amicus Curiae brief writes in Ruan vs. the United States:

PROMBLEM DOJ’S RED FLAG

” There are many problems with DOJ’s “red flags” theory. It has no basis in the CSA or its implementing regulations, or even in the DEA’s Pharmacist’s Manual. It imprudently dismisses the individualized, case-by-case approach that pharmacists take when filling prescriptions in favor of a categorical approach to culpability.10 

RED FLAG OF RUBBISH

And it traps pharmacists in an untenable position—either face liability under the CSA for filling a facially valid prescription that raises a “red flag,” or face state-based professional liability,11 and even civil suits,12 for refusing to fill such a prescription.”

“The U.S. Department of Justice (DOJ) has aggressively attempted to sidestep § 1306.04’s knowledge requirement. Citing pharmacists’ “corresponding responsibility,” DOJ has argued that pharmacists are liable for filling prescriptions that allegedly present so-called “red flags”—factors that do not necessarily bear on a prescription’s facial validity but that,

ADVOCATES FOR SICKLE CELL PATIENTS

in DOJ’s opinion, suggest the prescriber may have written it for an illegitimate but that a pharmacist who fills it must be doing so “knowingly.”

Under DOJ’s theory, the presence of one or more “red flags” not only proves that a prescription is illegitimate but that a pharmacist who fills it must be doing so “knowingly.”

2. “The “red flags” advanced by DOJ include patients seeking to fill “new prescriptions for controlled substances a patient has never received before”; 2 

3. certain combinations of prescribed drugs;3 

4. providing physician-ordered refills when “one to three days of supply remained”;4 

90MME(MORPHINE MILLGRAM EQUIVALENT)

5. late filling of prescriptions;5 

6. dispensing the same medications “for the same patients over long periods”;6 

SUPPOSED RED FLAGS

7. prescriptions for doses above “90 [morphine milligram equivalents]/day”;7 

8. and prescriptions for more than one “immediate-release opioid sufficiently close in time that the supplies would have overlapped.”8 

9. Even though in many circumstances these supposed “red flags” have legitimate explanations (medical or otherwise), DOJ has gone so far as to argue that the presence of one or more of these elements is “near conclusive evidence of a prescription’s invalidity.”9 

________________________________________

2 Compl. ¶ 79, United States v. Ridley’s Family Markets, Inc., No. 1:20-cv-00173-TS-JCB (D. Utah Dec. 4, 2020), ECF No. 2.

3 See, e.g., id. ¶¶ 68–72.

4 Compl. ¶ 67, United States v. Shaffer Pharmacy, No. 3:21- cv-00022-JZ (N.D. Ohio Jan. 6, 2021), ECF No. 1.

5 See, e.g., Compl. ¶ 72, United States v. Howen, No. 1:21-cv- 00106-DAB-SAB (E.D. Cal. Jan. 26, 2021), ECF No. 1.

6 Compl. ¶ 66, United States v. WeCare Pharmacy, LLC, No. 8:21-cv-00188-MSS-AEP (M.D. Fla. Jan. 26, 2021), ECF No. 1.

7 Compl. ¶ 75, United States v. Chip’s Discount Drugs, Inc., No. 2:20-cv-00010-LGW-BWC (S.D. Ga. Feb. 12, 2020), ECF No. 1.

8 Compl. ¶ 361, United States v. Walmart Inc., No. 1:20-cv- 01744-CFC (D. Del. Dec. 22, 2020), ECF No. 1.

9 Mem. in Opp’n to Def.’s Mot. to Dismiss at 5 (emphasis added), 8, United States v. Ridley’s Family Markets, Inc., No. 1:20- cv-00173-TS-JCB (D. Utah Mar. 8, 2021), ECF No. 31.

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DOJ: PHARMACIST MUST second-guess the appropriateness of the prescriptions???

According to DOJ, when faced with a prescription presenting one or more “red flags,” a pharmacist must identify each issue, take steps to resolve it, and document in writing how it was resolved—no matter how many times the same patient has presented the prescription.

DOJ I’M WATCHING YOU

Until and unless each “red flag” is resolved, DOJ says, a pharmacist must second-guess the prescription’s appropriateness, override the prescriber’s medical judgment, and refuse to fill it—or else face the threat of liability.

A. Reflecting the distinct roles of prescribers and pharmacists, § 1306.04 im- poses liability only on pharmacists who “knowingly” fill an illegitimate prescription.

“Although § 1306.04(a) regulates both prescribers and pharmacists, the two roles are far from interchangeable, including for purposes of determining potential liability. With different licenses, education, skill sets, responsibilities, and workplaces from physicians, pharmacists play a vital but distinct role in a patient’s care.

Specifically, when dispensing a controlled substance to a patient, as prescribed by a physician, a pharmacist relies on the physician’s assessment of the patient’s needs.

VILASHINI GANESH MD DOJ TARGET VICTIM 63 MONTHS PRISON

The pharmacist has neither examined nor diagnosed the patient and lacks the information the physician has collected on the patient’s medical situation, records, and history, including such things as x-rays, ultrasounds, lab results, and treatment plans.

The CSA recognizes pharmacists’ circumscribed role in dispensing controlled substances. It provides that pharmacists may not dispense Schedule II controlled substances “without the written prescription of a practitioner,” 21 U.S.C. § 829(a) and that they risk criminal and civil liability if they do, see id. §§ 841(a), (c), 842.

The CSA’s implementing regulations further explain that a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. § 1306.04(a).

The regulations separately provide that such a prescription “may only be filled by a pharmacist, acting in the usual course of his professional practice and either registered individually or employed” by a registered entity. 21 C.F.R. § 1306.06.

KATHYLUN DOUGLAS CHICAGO TRIBUNE REPORTER PAIN CARE VICTIM PHARMACIST PROFILING

Consistent with the division of responsibility be- tween prescribers and pharmacists, § 1306.04 limits when pharmacists may be held liable for filling controlled-substance prescriptions to situations where a pharmacist knows a prescription is illegitimate:

The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.

An order purporting to be a prescription issued not in the usual course of professional treatment or legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. [§] 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

21 C.F.R. § 1306.04(a) (emphasis added). A pharmacist violates this provision only if the pharmacist “knowingly fill[s]” a “purported” prescription—i.e., a prescription that was not written, “in the usual course of professional treatment.” Ibid. (emphasis added).

WHAT DOES THAT MEAN??

What does that mean and how is that determined?

According to Walter F. Wrenn, MD., a Philadelphia, Pa., area physician who practice medicine for over 40 years

” The physician saw and examined the patient. They made a diagnosis and prescribed medication.

A physician is trained to conduct a history and physical examination on a patient. The physician is taught to believe the historical narrative of the patient. They are not trained to question the validity of the information given to them by the patient.

Another common theme heard at trial is that the physician overprescribed.

Another term and charge are that the prescriber prescribed a highly addictive medication.

Edward Hardy Pain Sickle Cell Advocate

It hasn’t been but the term is still used. Addiction to opiate pain medication is not dose-dependent.  Opiate pain medication can become addictive regardless of dose.

How is highly addiction determined?

Why?

Because the CSA gives the physician the right to prescribe controlled medication as long as it is for a professional purpose and a legitimate medical reason. 

The DOJ/DEA is familiar with this process and uses it to incriminate physicians. The undercover agents sent to physician offices have been trained and given information and language to use to achieve their goal of getting the physician to prescribe controlled medication.

At trial, this same agent testifies that they didn’t have the medical condition that required a controlled medication for treatment.

This statement leads to the charge that the medication prescribed by the physician was not for a professional purpose and not for a legitimate medical reason.

Any patient who fits these criteria and presents a legitimate prescription should be singled out as an individual with addiction and denied treatment. The pharmacist should refuse to fill their prescription. 

All of these terms have been invented by the DOJ/DEA. 

Why?

I believe that once they realized that the war on drugs was a total failure that they got in a room and determined that the only way to save their jobs was to invent a new drug dealer.

That new drug dealer invented by the DOJ/DEA was a physician. The new white coat drug dealer.”

Scott Thomas, “LOW HANGING FRUIT”

IT’S NOT A QUESTION OF LAW…BUT DECEPTION

THE TESTIMONY OF ROBERT B J DORION THE GODFATHER OF ALL RED FLAGS ACADEMIC FRAUD SCAMS AND LEARNING FROM THE MASTER DEA EXPERT PHARMACIST

This agency alone has created an unseen problem. When this matter becomes public, officers and administration should be prosecuted.  The courts should classify the DEA system as deceitful.  Criminal attorneys should file complaints under Giglio, and every drug arrestee would be released from prison.  The unethical and illegal practices of the DEA will one day come to light.  

DEA

” The DEA was established in 1973 ostensibly to consolidate drug enforcement activities into a “superagency” that would bring together federal drug enforcement resources. In the last 50 years, it’s been a tremendous waste of resources and left a wake of devastation in the United States and abroad.” 

Robert B. J. Dorion, a former DEA pharmacist expert witness, who also served as Dean of the University of Florida College of Pharmacy

Robert B J Dorion:

“it’s not a question of “law it’s a question convincing the judge or jury”

Robert B J Dorion:

To get back to your practical question…..Then who is correct in the eyes of the law…… You have to demonstrate as an expert witness that you have taken the means and are knowledgeable in whatever you are promoting…… Whether it’s a conclusion…… Or a method that you have adopted to arrive at that conclusion

Robert B J Dorion:

 You will be cross-examined critically…..that’s where you may buckle and fold unless you can demonstrate that you are competent

Thus DEA expert pharmacist establishes the role of a grifter, undermining common medical procedures and endangering the health and safety, threatening human dignity, the common good, and peace of society in this America or for that matter around the world.

From Boukman The Trouble Maker:

” the evil of the authorities of the Department Of Justice has been to manufacture a pretext to undermine then attack and criminalize our knowledge and training of medicine,… Our God asks only good works of us but this God who is so good orders us learned souls to take a stance, to fight and he will direct our hands, he will aide us to throw away the image of the enemies who thirst for our tears a the images of helplessness and inferiority, listen to the voice of liberty who speaks in the heart of all of us.”

FOR NOW, YOU ARE WITHIN

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

THE NORMS

Thank You, I ask you to donate to the Pharmacist For Healthcare Legal  Defense Fund, fight the DEA attack on me & Pronto Pharmacy now Gulf Med Pharmacy our goal 100k, Appeal Court 1st Dist Wash DC. 
Click to Donate:  http://gf.me/u/2qffp4 #GoFundMe or cash app: $docnorm 
or to Zelle: 3135103378

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PBM industry: feds change the oversight regulations and THEY MOVE THE GOAL POST

Feds to Stop #Pharma ‘Rebates’ to #PBMS, But President Biden Delays.

The Department of Health and Human Services #Removed the ‘Safe Harbor’ Protection from the #AntiKickback Statute for Drug Rebate Payments to PBMs.

**Note Trump Initially Put New Regulation in Place and Biden Has Delayed it Until 2023.

In Other Words, Drug Companies Must Stop Giving Their Rebate Payments to PBMs and Give them Directly to #Seniors on #Medicare Instead.

A Study Estimates that These Rebate Payments to Seniors Would #Save Them $381 – $1,522 Per Person Per Year.

To Potentially Circumvent This Regulatory Change, the PBM Express Scripts (Now Part of Cigna) Started a Group Purchasing Organization (#GPO) Called Ascent Health Services that is Based in Switzerland.

Why?

Reason: Pharma Companies Can Still Pay ‘Administrative Fees’ (in place of Rebates) to the PBM’s GPO Because GPOs Are Still Protected Under #SafeHarbor from the Anti-Kickback Statute.

@CVS Has Started Their Own GPO Called Zinc as Well.

#InsuranceCarriers and PBMs DO NOT Need to Follow These New Regulations When It Comes to Their Employer Clients and their Employee Health Plans–the Rebate Payments to PBMs Can Remain. 

Omicron Cases Soar, but Deaths on the Decline, White House Says

I can see when there is a “postmortem ” of this mutation of the COVID-19 virus,  it will be concluded that – as has already been stated – with this mutation many infected people are asymptomatic and thus continue with their normal day to day life and thus this mutation is being more easily spread.

Omicron Cases Soar, but Deaths on the Decline, White House Says

https://www.medscape.com/viewarticle/965751

Cases of the highly transmissible Omicron variant continue to skyrocket, but hospitalizations and deaths remain much lower by comparison ― another sign that Omicron is less deadly than previous strains, White House officials said on Wednesday.

“The rapid increase of cases we’re seeing across the country is, in large part, a reflection of the exceptionally transmissible Omicron variant,” CDC Director Rochelle Walensky, MD, said at a White House briefing. “While our cases have substantially increased from last week, hospitalizations and deaths remain comparatively low right now.”

“This could be due to the fact that hospitalizations tend to lag behind cases by about 2 weeks, but may also be due to early indications we’ve seen from other countries like South Africa and the United Kingdom of milder disease from Omicron, especially among the vaccinated and boosted,” she continued.

The 7-day daily average of COVID-19 infections is 240,400 ― an increase of 60% since last week. But hospital admissions have only increased by 14%, at 9,000 per day. Deaths are averaging 1,100 per day, a decrease of about 7%.

Early data from other countries aligns with this trend, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease and medical adviser to President Joe Biden. According to a study from one South African hospital published Tuesday, patient deaths from Omicron averaged 4.5%, compared to 21.3% from previous waves. About 45% of patients with Omicron required supplemental oxygen, while 99% of patients from previous COVID-19 waves needed breathing assistance. The average length of stay for Omicron patients was 4 days ― less than half the average for other strains.

Fauci noted that while the Omicron variant seems to replicate faster in the bronchial tubes, this occurs much more slowly in the lungs, which could account for the milder disease.

Both Walensky and Fauci stressed that those with vaccine protection are far less likely to become infected with Omicron and are less likely to be hospitalized and die should they be infected.

“The risk of severe disease from any circulating variant, including Omicron, is much, much higher for the unvaccinated,” Fauci said.

Walensky also addressed the controversial updated guidance reducing isolation time for infected health care workers, along with looser guidelines for people exposed to COVID-19 and those infected without symptoms.

“Let me make clear that we are standing on the shoulders of 2 years of science, 2 years of understanding transmissibility, and a lot of information that we have gleaned from the wild type virus, as well as the Alpha and Delta variants, and more that we continue to learn every single day about Omicron,” she said. “Studies have demonstrated that when people are infected with SARS-CoV-2, people are most infectious the 1 to 2 days before symptoms develop, and the 2 to 3 days after. After 5 days, the risk of ongoing transmission substantially decreases.”

International problem: pharmacy staffing issues coming to a BREAKING POINT ?

by every objective measure the coronavirus vaccine campaign has failed

Sobering numbers as this troubled year draws to a close:

505,013,980 coronavirus shots injected in the U.S. and territories[1]
983,756 reports of injury to VAERS
20,622 reports of death
34,615 reports of permanent disability
3,365 reports of miscarriage
following coronavirus vaccinations.

And yet,
All-cause mortality is higher in 2021 than in 2020.
COVID-19 deaths are higher in 2021 than in 2020.
New coronavirus cases in the U.S. just reached a record high.

The data is the data and by every objective measure the coronavirus vaccine campaign has failed.

Thank you to everyone who shares OpenVAERS with others. This information is getting through to policy makers and the wider public. We appreciate your encouragement and moral support for this work.

 

 

The OpenVAERS Team

Cato Files Brief in Major Supreme Court Case About Opioid Prescriptions: When Are Doctors Drug Dealers?

Cato Files Brief in Major Supreme Court Case About Opioid Prescriptions: When Are Doctors Drug Dealers?

https://www.cato.org/blog/cato-files-brief-major-supreme-court-case-about-opioid-prescriptions-when-are-doctors-drug

Dr. Xiulu Ruan practiced medicine as a board‐​certified pain specialist in Mobile, Alabama. His practice served almost 8,000 patients and employed 57 people. In 2016, he was indicted for unlawfully distributing controlled substances (opioids) and many related criminal charges. At his trial, the government argued that some of Dr. Ruan’s prescriptions fell “outside the usual course of treatment” and called numerous experts to testify to that claim. Dr. Ruan countered with his own experts who testified that his prescriptions were medically valid.

A jury convicted Dr. Ruan based on jury instructions that did not include a “good‐​faith” defense for doctors who truly believe they are practicing good medicine.

The Eleventh Circuit, unique among all the circuits, does not allow a good‐​faith defense, meaning doctors can be convicted of serious crimes—Dr. Ruan was sentenced to 21 years in prison—for merely being negligent in how they write prescriptions. And doctors of course disagree in good faith on the proper standard of care all the time, but malpractice claims adjudicated by civil courts are the proper venues to punish doctors who are merely negligent in their medical practice.

The Eleventh Circuit upheld Dr. Ruan’s conviction and he appealed to the Supreme Court, which agreed to hear his case. Cato has filed an amicus brief in support, arguing that the Controlled Substances Act (CSA) requires a good‐​faith defense to differentiate between doctors who are earnestly practicing medicine and those who distribute controlled substances without a medical purpose—i.e. “pill pushers” or “pill mills.”

Over 100 years ago, the Harrison Narcotics Act became the first major federal drug law. It ended the practice of over‐​the‐​counter opioids and cocaine while allowing various medical professionals to distribute the drugs “in the course of his professional practice only.” The Harrison Act was a tax law, and it was enforced by the Treasury Department. Within a few years, treasury agents were prosecuting doctors who were alleged to have prescribed opioids to patients in order to maintain their addictions.

The Supreme Court heard many challenges to the Harrison Act from various doctors who were charged under it. In 1919, the Court ruled that prescribing “maintenance doses” to people who were addicted to opioids did not qualify as a legitimate medical purpose. At no point, however, did the Court assume that a good‐​faith defense was not available to doctors who legitimately believed they were practicing good medicine.

That interpretation carried over to the CSA, which became the main federal drug law in 1970. We argue that allowing doctors to use a good‐​faith defense is not only historically justified, but it is essential to keeping the CSA within proper constitutional boundaries. States retain the power to regulate the medical profession under their traditional police powers. Without a good‐​faith defense, the CSA comes close to unconstitutionally regulating the medical profession. Disagreements over standards of care are properly adjudicated in state courts, and federal jurisdiction should only kick in when a doctor has abandoned the subjective intent to practice medicine and become a drug dealer.

Moreover, prosecuting doctors for “misprescribing” has become so common that many doctors are afraid to prescribe opioids. Yet there is no agreed‐​upon standard for “misprescribing,” especially when it comes to chronic pain patients, of which there are about 20 million in the country. The standards are so vague that doctors don’t know when they have crossed a legal line, which undermines the Constitution’s guarantee of due process of law.

The Supreme Court should overturn Dr. Ruan’s conviction and correct the Eleventh Circuit’s erroneous interpretation of the Controlled Substances Act. Doctors who sincerely believe they are practicing good medicine should not be treated like drug dealers.