Coronavirus vaccine: MIT Professor calls for immediate suspension of COVID mRNA vaccine

https://www.medpagetoday.com/opinion/second-opinions/103155

The number of health professionals urging for the suspension of COVID mRNA vaccine is increasing. The call for withdrawing the vaccine is getting stronger.
Recently, MIT Professor Retsef Levi took to Twitter to share the harm mRNA vaccines are causing in young people. “The evidence is mounting and indisputable that mRNA vaccines cause serious harm including death, especially among young people. We have to stop giving them immediately!,” the MIT Expert in Analytics, Risk Management, Health Systems, Food & Agriculture Systems, Manufacturing & Supply Chain Management has tweeted.

Professor Levi’s video, in which he has warned against the use of mRNA vaccine, has received more than 1 million views so far.
“All COVID mRNA vaccination programs should stop immediately”
“I’m filming this video to share my strong conviction that at this point in time, all COVID mRNA vaccination programs should stop immediately,” Professor Levi has said.
“They should stop because they completely failed to fulfill any of their advertised promises regarding efficacy. And more importantly, they should stop because of the mounting and indisputable evidence that they cause unprecedented levels of harm, including the death of young people and children,” he continued.

“mRNA vaccines indeed cause sudden cardiac arrest”
“I believe that the cumulative evidence is conclusive and confirms our concern that the mRNA vaccines indeed cause sudden cardiac arrest as a sequel of vaccine-induced myocarditis. And this is potentially only one mechanism by which they cause harm,” he said.

“I personally became concerned with vaccine safety around the middle of 2021 when it became known that the mRNA vaccines cause myocarditis, and inflammation of the heart,” he says. “I was very concerned that it would not be detected by the existing vaccine safety surveillance systems. Motivated by that, we decided to analyze the Israel National EMS data to see if there are any signals of increased out of hospital adverse events,” he added and continued to substantiate his claims with the results of several studies.

“We detected an increase of 25% in the cause with cardiac arrest diagnosis”
“The analysis of the EMS calls and diagnosis data from 2018. throughout the first half of 2021 revealed some very concerning signals. We detected an increase of 25% in the cause with cardiac arrest diagnosis among ages 16 to 39. In the first half of 2021, exactly when the vaccination campaign in Israel was launched, a smaller increase was also detected in the older ages. Moreover, we also detected a statistically significant temporal correlation between the number of the Pfizer vaccine doses administered to this population and the number of EMS calls with cardiac arrest diagnosis,” says Professor Levi.

“Data from the UK, Scotland, and Australia replicate the data from Israel. Additional data from Israel indicates that in 2021, the EMS in Israel conducted more than 3,000 more resuscitations compared to 2019, which amounts for an increase of 27%. Two prospective studies from Thailand and Switzerland in which vaccines were tested before and after they received a vaccine, indicate that the rates of heart damage are likely to be significantly higher than the rates detected by clinical diagnosis. This is exactly the same finding that the US. military found in 2015 when it conducted a similar study on the smallpox vaccine.”

He continued, “Another study from the Harvard Medical School detected in the blood of children with vaccine-induced myocarditis, an entire spike, which is another indication of the underlying mechanism of harm, but in fact has even broader implications about the safety of the vaccine given the repeated evidence that we have that the mRNA and the lipids are actually penetrating the blood system.”

“And finally, autopsies of people that died closely after they received the vaccine indicate that in a large number of cases, there is strong evidence that the death was caused by vaccine-induced myocarditis. So presented with all of this evidence, I think there is no other ethical or scientific choice but to pull out of the market these medical products and stop all the mRNA vaccination programs. This is clearly the most failing medical product in the history of medical products, both in terms of efficacy and safety,” he said.

“This is huge”
Sharing Professor Levi’s video on his personal social media accounts, Dr Aseem Malhotra who has been vocal against the administration of mRNA vaccines has posted: “Eminent MIT Professor & expert on drug safety analytics Retsev Levi calls for immediate suspension of all covid mRNA vaccines

‘They should stop because they cause an unprecedented level of harm including the death of young people and children’

mRNA vaccines work by introducing a piece of a lab synthesized mRNA which corresponds to the viral protein. When the cells produce the viral protein using the mRNA an immune response is triggered. Not just COVID, mRNA vaccines have also been studied before for flu, Zika, rabies, and cytomegalovirus (CMV). Cancer research also uses mRNA to trigger the immune system to target specific cancer cells.

How do mRNA vaccines work?

A little portion of a protein typically located on the viral outer membrane is introduced as part of an mRNA vaccine’s delivery mechanism. (People who receive an mRNA vaccination are not exposed to the virus and cannot contract the infection through the vaccine).

There are three different types of COVID vaccine which are administered to improve the immunity against the virus which had emerged in 2019 in Wuhan, China. While mRNA is administered to people, vector vaccine and protein subunit vaccines are also in use.

Here are the answers to few common questions related to mRNA vaccines:

1. What is mRNA vaccine?
   mRNA vaccines use a piece of mRNA that corresponds to a viral protein.
2. How to mRNA vaccines work?
   These vaccines work by using laboratory synthesized mRNA to teach our cells how to make a protein to trigger immune response.
3. What vaccines are mRNA?
   Pfizer-BioNTech and the Moderna COVID-19 vaccines use mRNA .
4. What are the other types of COVID vaccines available?
   The other types of COVID vaccine available are vector vaccine and protein subunit vaccine.

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This graphic represents into whose pockets/coffers where the $$ that the pt pays at the register ends up going.  I think that this proposal clearly explains the power of those companies who has the largest pots of money to pay lobbyists to convince Congress and members of the Administration as to what the big corporations want those bureaucrats to believe as what the corporation wants them to believe as “the truth”.  This is a settlement from the PBM Centene with Indiana Medicaid – just this month – for overcharging the state Medicaid  Centene will pay Indiana $66.5 mln to settle Medicaid overcharge allegations

Centene said in its most recent quarterly filing with the U.S. Securities and Exchange Commission that it had settled with 13 states, was in talks with others and had set aside $1.25 billion to resolve related claims.

Pharmas, wholesalers, Pharmacies all have the business cost of keeping a inventory. The insurance/PBM has COMPUTERS as the primary business overhead. The pharmas & wholesalers have shipping cost of product to their customers and the PBM charges the Pharmacies $0.25 per Rx electronic submission.  So the FEDS are going after the part of the Rx distribution system, which may have the highest cost of doing business and the lowest net profits… while ignoring the part of the distribution system with the highest net profit.

Just remember their is no prerequisite experience nor educational qualification/certification to become an elected or un-elected bureaucrat

Medicare announces plan to recoup billions from drug companies

https://www.npr.org/sections/health-shots/2023/02/09/1155804068/medicare-releases-a-draft-of-its-new-prescription-drug-pricing-rules

Medicare’s historic plan to slow prescription drug spending is taking shape. Thursday federal health officials released proposed guidance that outlines the first of a pair of major drug price reforms contained in the Inflation Reduction Act. Those reforms are projected to save Medicare roughly $170 billion over the next decade.

President Joe Biden touted the effort underway earlier this week in his State of the Union address. “We’re taking on powerful interests to bring your health care costs down so you can sleep better at night,” he said.

Spending on drugs in Medicare, which covers 64 million seniors and people with disabilities, nearly tripled from about $85 billion in 2009 to $240 billion in 2020. Medicare spends an average of $2,700 per beneficiary on retail drugs each year.

A team of roughly two dozen analysts, economists and other technical experts within the Centers for Medicare & Medicaid Services is now knee-deep in the painstaking process of translating the administration’s lofty law into ironclad policy.

The new details released Thursday outline how Medicare will use its new authority to claw back refunds from drugmakers for price increases that outpace the rate of inflation.

Dr. Meena Seshamani, director of the Center for Medicare, called the guidance “an important step in our work to lower out-of-pocket drug costs and strengthen the sustainability of the Medicare program for current and future enrollees.”

The agency is bracing for its work to face legal attacks, gamesmanship and lobbying from a formidable opponent: the pharmaceutical industry. The looming battle between bureaucrats and industry will help determine how much money Medicare saves.

CMS is staring down several challenges. The first is timing.

The authors of the Inflation Reduction Act, which armed Medicare with these new powers last August, gave the agency just a few months to finalize policy details.

“Congress has pushed them very hard,” said Richard Frank, a senior fellow at the Brookings Institution who served in HHS under President Obama. “They’re building the ship and trying to sail it at the same time.” To address that pressure, the agency is hiring furiously, working to add another 75 people to its new group overseeing this effort.

Drug companies, which spent $160 million lobbying the government last year, have their own teams working tirelessly. “We are definitely not sitting on our hands,” said Alice Valder Curran, who advises drug companies on pricing strategy at law firm Hogan Lovells. “We’re going to scour the guidance.”

Curran said companies have spent the months since the Inflation Reduction Act passed analyzing its potential impact on drugs they sell now – and those in their pipelines. With today’s release of draft rules, she added, companies can now begin to answer their questions about how the law will be implemented.

Medicare targets drugmakers who hike prices too fast

The new plan to lower drug prices announced Thursday requires drugmakers to refund Medicare for any price increases that outpace the rate of inflation.

“The inflation rebate program intends to hold drug companies accountable,” said Medicare’s Seshamani.

Inflation rebates are expected to deliver $70 billion in savings over the next decade on a large number of drugs – potentially more than 1,000, according to the Kaiser Family Foundation. “We’re talking about the same drug from one year to the next – no change to the product – but the price goes up in many cases 10 percent, sometimes even higher,” said Juliette Cubanski, deputy director of the program on Medicare policy at KFF.

The inflation rebate, with its clunky name and complex formulas, has caught less attention than Medicare’s other major new authority to cut drug spending by negotiating directly with drugmakers, which CMS intends to lay out in detail this spring.

That negotiation power is unprecedented and will target some of the country’s biggest ticket drugs, starting with 10 blockbusters in 2026. The number of negotiated drugs will grow to 60 by the end of this decade, and will save Medicare nearly $100 billion by 2031.

Combined, these two new powers represent Medicare’s antidote to drugmakers continuing to raise prices, particularly on products that have no competition.

Potential loopholes jeopardize size of savings

The guidance answers important mechanical questions about these rebates. For example, beginning April 1, some refunds will be passed directly on to seniors, lowering their out-of-pocket costs for certain drugs, which could include expensive cancer treatments. The guidance outlines exactly how those rebates will be calculated, passed through providers and into people’s pockets – no small logistical feat.

Also tucked inside the 71 pages of guidance are details that highlight potential loopholes in the law that could be exploited by drugmakers, representing another key challenge CMS faces in maximizing savings.

Anna Kaltenboeck, who helped craft the Inflation Reduction Act as a senior health advisor to the U.S. Senate Committee on Finance and is now a principal at the health research firm ATI Advisory, said lawmakers and regulators tried to learn from other federal programs that use inflation rebates.

Medicaid, which covers 82 million low-income Americans, has clawed back very similar inflation rebates for 30 years. While doing so has effectively lowered Medicaid’s spending, drugmakers have successfully avoided hundreds of millions of dollars in payments by taking advantage of flexibilities built into the law. Similar gamesmanship could be magnified in Medicare, which spends three times more on drugs than Medicaid.

While Kaltenboeck believes Medicare’s inflation rebate rules effectively close some known loopholes, she admits others may be lurking. “There are almost an infinite number of ways [that] a manufacturer might think of to evade these new policies,” Kaltenboeck said.

The Office of Inspector General for the Department of Health and Human Services has said it’s on high alert and has published multiple reports warning about potential weaknesses in the rebate law.

Finally, industry advisor Curran said, this new guidance also offers a first highly anticipated look at the federal government’s broader philosophical approach to wielding its pair of new powers. “Everyone is going to be reading the tea leaves – are they being strict or less strict – and trying to draw conclusions from that.”

The rebate law gives Medicare discretion to reduce or waive rebates for companies whose drugs experience shortages or a supply chain disruption. If, for example, an earthquake hits a company’s lone manufacturing plant, they may need to hike prices to recover economically and invest in plant upgrades. But a waiver that is too lenient, said economist Richard Frank, could also incentivize bad behavior by manufacturers. “You’re trying to find that balance.”

Industry turns its attention toward negotiation

The public has until March 11 to comment on the details released Thursday, after which Medicare will revise and publish final guidance on the inflation rebate provision. “It’s very important to us to hear from all interested parties and incorporate all of those perspectives and expertise and experiences as we thoughtfully implement this law,” said Medicare’s Seshamani.

Medicare now turns its attention to finalizing and publishing similar guidance on price negotiation. It’s an authority the industry is still surprised lawmakers managed to pass. “​​We’re having to wrestle with responding to guidance about something we never thought was going to happen,” said Jenny Bryant, Executive Vice President for Policy and Research at the industry trade group PhRMA.

Bryant said the forthcoming guidance, which targets some of the industry’s top sellers, has the group’s full attention. “Our energy is going into thinking about this completely novel thing we know extraordinarily little about how the agency is going to approach.”

Many experts believe that manufacturers will comb through those details looking not only for loopholes, but also for ammunition. “Manufacturers are absolutely going to be looking to mount a legal challenge,” said former Senate advisor Kaltenboeck. PhRMA said it expects pressure for legislative change to grow too.

Those legal stakes are one more reason people like former HHS official Richard Frank worry about the agency moving so fast through such technical work. The Affordable Care Act , the last health care law this consequential, was also written and implemented in a hurry. A few words mistakenly included in the final language of that law ultimately landed it before the Supreme Court.

“I do think the lessons learned from the ACA are fresh on people’s minds,” Richard Frank said.

Seshamani, who helped implement the ACA, said that’s why the agency has “set up monthly technical calls with drug manufacturers [and] regular strategic policy meetings with patients groups, providers [and insurance] plans.”

Dan Gorenstein and Leslie Walker are producers with Tradeoffs, a podcast exploring health policy.

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States have better options than expanding Medicaid to care for their poor

https://americansforprosperity.org/alternatives-to-medicaid-expansion/

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DEA Manual Changes Cause Uproar Over Pseudoephedrine Dispensing

https://www.uspharmacist.com/article/dea-manual-changes-cause-uproar-over-pseudoephedrine-dispensing-1

A change in the Drug Enforcement Administration (DEA)’s 2022 Pharmacist’s Manual is creating confusion about dispensing of pseudoephedrine products.

Three key pharmacy groups—the American Pharmacists Association (APhA), the National Community Pharmacists Association (NCPA), and the National Association of Chain Drug Stores (NACDS)—sent a letter to Thomas W. Prevoznik, deputy assistant administrator, Office of Diversion Control Policy at the DEA, seeking clarification. The manual states that the federal daily sales quantity limit of 3.6 g applies when a pharmacist dispenses pseudoephedrine pursuant to a prescription that federally does not require a prescription.

In the letter, the pharmacy groups argued that it has been previously understood that the federal daily sales quantity limit does not apply when dispensing pseudoephedrine products pursuant to a prescription.

“It has been our understanding since the Combat Methamphetamine Epidemic Act (CMEA) passed into law over 15 years ago that the federal daily sales quantity limit does not apply when dispensing pseudoephedrine products pursuant to a prescription,” according to the letter. “Based on discussions among our different associations and DEA officials contemporary with the passing of the CMEA and DEA’s promulgation and finalizing of implementing regulations, it has been our understanding that any SLCP [scheduled listed chemical product] that is dispensed pursuant to a prescription order is not subject to any of the requirements of the CMEA, irrespective of whether the product is a legend drug under federal law. We believe that DEA’s apparent policy reversal, seemingly announced in 2022 version of the Pharmacist’s Manual, will cause great harm to patients that rely on pseudoephedrine products to treat chronic medical conditions.”

The pharmacy groups pointed out that those patients would have to make additional office visits to their prescribers for much more frequent prescriptions and much more frequent visits to their pharmacies to receive their pseudoephedrine medications. “Notably, this apparent policy change would likely provide little to no additional benefit, as we are not aware that patients taking pseudoephedrine products pursuant to a prescription, without a federal sales limit for the past 15 years, have been even a minor contributor to the problems of methamphetamine abuse, production, or diversion,” the letter added.

The NACDS specifically questioned the legality of the change, explaining, “Considering that sales of SLCPs pursuant to a prescription result from a professional evaluation and through a learned intermediary, we do not believe that these types of transactions could be construed as being with a ‘walk-in customer or in face-to-face transactions by direct sales.’ When a patient presents a prescription to a pharmacy for a SLCP, such as pseudoephedrine, they are not merely walking into the pharmacy to conduct a transaction upon their own accord. Rather, they are presenting to the pharmacist an order given to them from a prescriber that has conducted a medical examination and evaluation. Consequently, we do not believe that CMEA sales limits would apply in these circumstances.”

The letter goes on to say that since the CMEA does not apply to legend drugs, the pharmacy groups maintain that it should also not apply to nonlegend drugs that are dispensed under the same procedures as a legend drug, “which are more stringent than the requirements of the CMEA.”

“APhA, NACDS, and NCPA thank DEA for the consideration of our concerns about its apparent policy change announced in the 2022 version of its Pharmacist’s Manual,” the letter concluded. “We urge DEA to issue official guidance clarifying that the federal sales limits of the CMEA, including the federal daily sales quantity limit of 3.6 grams, does not apply when a pharmacist dispenses pursuant to a [pseudoephedrine] prescription…”

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

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Bureaucrats are telling your doctor how to treat pain. And patients suffer needlessly.

https://www.usatoday.com/story/opinion/2023/02/16/fear-opioids-causing-patients-needlessly-suffer-severe-pain/11254143002/

Thanks to pressure from lawmakers, government agencies and policymakers who inserted themselves into the patient-doctor relationship, patients became the victims of the never-ending war on drugs.

A decade ago, most people thought of Tylenol (acetaminophen) as a medicine for fever, malaise and minor aches and pains. Nobody imagined that it would become the go-to drug for treating moderate, let alone severe, postoperative pain. 

But this is just what has happened. Thanks to pressure from lawmakers, government agencies and policymakers who inserted themselves into the patient-doctor relationship, patients became the victims of the never-ending war on drugs.

Now, doctors frequently offer only acetaminophen to treat painful conditions despite the drug’s inability to remedy them. 

Doctors pressured to avoid pain medication

Policymakers’ exaggerated fear of opioids has pressured hospitals, doctors and dentists to switch to acetaminophen, no matter how severe the patient’s pain. Sometimes, the drug is given intravenously in high doses as part of “opioid-sparing protocols.” We believe using the drug in this way is ill-advised, cruel and borders on malpractice. 

Lawmakers believed they had to do something about the opioid overdose crisis, which has grown exponentially since the 1970s. The crisis was driven by a growing population of nonmedical drug users accessing drugs from the black market.  

States dictate rules on prescriptions

Now, nearly 40 states have passed laws dictating the maximum number and dose of opioids that doctors are permitted to prescribe to their patients, all based on the misguided notion that medical use of prescription pain pills caused the crisis.

But what’s really fueling overdose deaths is drug prohibition and the dangerous black market that it creates. The Centers for Disease Control and Prevention got into the act by guiding doctors in treating pain, an area not in the agency’s wheelhouse.  

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The evidence clearly shows that acetaminophen alone is a poor choice for treating most types of pain. Multiple literature reviews show that the drug has limited analgesic utility. Several Cochrane systematic reviews, which are highly regarded, evidence-based analyses that carefully evaluate the quality of data in numerous studies, have questioned its ability to relieve pain caused by a variety of conditions. With few exceptions, it fails miserably. 

For example, studies reveal that acetaminophen effectively reduces fever in children. But, while the drug is frequently recommended for headache pain, its efficacy is mostly imaginary. A 2016 Cochrane review examined 23 studies, including more than 8,000 people with tension headaches. While 59% of the participants experienced relief within two hours, so did 49% of the group that received a placebo. 

The authors concluded, “Only 10% people with tension-type headaches get a benefit from (acetaminophen).” 

‘Do I need to go to the basement??’:President Biden, please get down to earth with Americans about the threats up in the air

A  2013 Cochrane review found the drug inferior to ibuprofen for reducing dental pain at all doses studied.  

Perhaps most telling is a 2021 review that included 36 systematic studies of 44 painful conditions. It concluded that acetaminophen provided modest pain relief for one of them, osteoarthritis of the hip and knee. There was no sound evidence of the drug’s ability to treat any other painful condition.

Yet now, some doctors give it intravenously for postsurgical pain, a cruel and unethical practice if there ever was one. 

Patients suffer agonizing pain

The government promulgates an erroneous fear of opioids that makes patients often endure agonizing postoperative pain they never would have experienced a decade ago, a violation of basic medical standards.

Yet, contrary to politicians’ beliefs, data show that the addiction rate of medically used opioids has been about 1%. Government data also show no correlation between the volume of opioids prescribed and the rate of abuse or addiction. 

The treatment and management of acute and chronic pain involve the same nuanced medical decision-making as treating hypertension, diabetes, infectious diseases and psychiatric disorders. Just as it is wrong for the government to dictate how doctors treat those conditions, it should butt out when doctors treat pain.

Doctors take an oath to ease suffering and do no harm. Government meddling is causing doctors to violate their professional credo. 

Dr. Jeffrey A. Singer practices general surgery in Phoenix and is a senior fellow at the Cato Institute. Josh Bloom is director of chemical and pharmaceutical science at the American Council on Science and Health. 

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This is a trailer of what is promised to be a longer video focusing on the realty of what – mostly chain pharmacists & techs – are dealing with on a day to day basis.

Here is another very sad story of a mid-40’s female Pharmacist that did not get to finish her shift … UPDATED: CVS Pharmacist: dies on the job from Cardiac MI – forced to wait for relief pharmacist to show up

I knew a young pharmacist – years ago – at a big box store that committed suicide… I have heard of a Rx staff member(s) curled up in the fetal position in the corner of the Rx dept – SOBBING !!

I am sure that the things that I heard about, is just a small percentage of the reality of what is going on in these chain Rx depts.

This is not a few exceptions to the rule… several months ago a number chain pharmacists – up in the New England area… that they were TEN DAYS BEHIND in filling Rxs… and they were being told by the District Manager to JUST FOCUS ON THE WAITERS…

I feel so sorry for all these chain pharmacies employees and I can’t understand why pts continue to patronize these chain pharmacies and don’t seem to understand just how much they are putting their health at risk.

This makes me so grateful for the independent pharmacy that is about one mile from our house. Over the last year, with all the chain pharmacies around the area failing to open some days and/or only a few hours a day when they could find a Pharmacist and tech that would come in and work a shift. Our Independent has had to add a tech to the staff, because apparently some of those pts patronizing the chain pharmacies found out that there was a better alternative.

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I have read where reimbursement from insurance for services provided to pts… when a mid-level practitioner provides the service the healthcare facility that they work for are paid 85% of what they get paid … if a MD provides the same service.  BUT, mid-levels are not paid 85% of the pay/salary that a MD gets. paid.

What these PRIVATE EQUITY FIRMS don’t understand, that the insurance industry will not let Equity firms make more money/profits in the long term.  They will either reduce what MD’s are paid or change the reimbursement for services provided by mid-levels.

What will the pt get?…. POORER OUTCOMES !!!

Staffing Group Replaces Doctors With NPs, PAs

https://www.medpagetoday.com/special-reports/features/103114

One physician contract management group is reducing costs by replacing doctors with nurse practitioners and physician assistants, according to a report by KHNopens in a new tab or window.

Hospitals like Tennova Healthcare in Clarksville, Tennessee have been outsourcing their emergency departments to medical staff management groups, which are in turn employing fewer physicians as a way to cut costs and increase earnings, according to a confidential company document obtained by KHN.

American Physician Partners took over the staffing of Tennova’s emergency department in 2019. The confidential company document explains the strategy to replace physicians with NPs and PAs, who often perform many of the same responsibilities as physicians, generate similar revenue for the company, and receive “less than half the pay,” according to KHN.

The document states that American Physician Partners “has numerous cost saving initiatives underway as part of the Company’s continual focus on cost optimization.” Those initiatives reportedly include a “shift of staffing” from doctors to NPs and PAs.

American Physician Partners told KHN that their staffing strategy is a way to ensure all emergency departments remain fully staffed. They also told KHN that this “blended model” allows physicians, NPs, and PAs “to provide care to their fullest potential.”

Critics say this strategy saves money at the expense of care quality. American Physician Partners is 50% owned by private equity firm BBH Capital Partners.

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I have often heard that those involved in our legal system have stated  that a GRAND JURY is so RIGGED that they could indict a HAM SANDWICH  !

according to https://en.wikipedia.org/wiki/Hippocratic_Oath     It is often said that the exact phrase “First do no harm” (Latin: Primum non nocere) is a part of the original Hippocratic oath. Although the phrase does not appear in the AD 245 version of the oath, similar intentions are vowed by, “I will abstain from all intentional wrong-doing and harm”. The phrase primum non nocere is believed to date from the 17th century.

In a 1989 survey of 126 US medical schools, only three of them reported use of the original oath, while thirty-three used the Declaration of Geneva, sixty-seven used a modified Hippocratic Oath, four used the Oath of Maimonides, one used a covenant, eight used another oath, one used an unknown oath, and two did not use any kind of oath. Seven medical schools did not reply to the survey.^[33]

As of 1993, only 14% of medical oaths prohibited euthanasia, and only 8% prohibited abortion.^[34]

In a 2000 survey of US medical schools, all of the then extant medical schools administered some type of profession oath. Among schools of modern medicine, sixty-two of 122 used the Hippocratic Oath, or a modified version of it. The other sixty schools used the original or modified Declaration of Geneva, Oath of Maimonides, or an oath authored by students and or faculty. All nineteen osteopathic schools used the Osteopathic Oath.

Apparently this prosecutor stated to the grand jury that this prescriber violated “the law”  of  “to do no harm”..  which seems there is no documentation of such an exact statement in any known copy of the Hippocratic Oath.

also according to the prosecutor in this case was quoted as saying:  The prosecutor argued that prescribing any opioid medication was illegal.  So it is ILLEGAL to prescribe – per federal law – any opioid medication that has been proven by the FDA as safe for use in humans.

FDA is part of the Executive Branch of the Federal Government as is the federal prosecutors under the Presidential Cabinet Attorney General Position.  So we have two parts of the Executive branch of our federal government in TOTAL DISAGREEMENT over the legality of the use of FDA approved opioids.

Since there is no clear cut laboratory tests that will provide the prescriber any measurable intensity of pain for any pt, the prosecutor in this case seems to suggest that prescribing any opioids for a pt without such testing – that does not exist –  is irresponsible and thus providing opioids without a valid medical necessity.

This is what the SCOTUS June 2022 (9-0) vote ruling that the DEA/DOJ could not use OBJECTIVE CRITERIA when evaluating a prescribing in treating pts with subjective disease issues. As of making this comment, it does not seem like the DEA has let to change it SOP in evaluating prescribers when they are prescribing opioids for pts suffering from acute & chronic pain.

https://www.cato.org/study/cops-practicing-medicine

To Coerce a Plea

https://www.linkedin.com/pulse/coerce-plea-jay-k-joshi/

My decision to enter a plea bargain never felt like a real decision, but instead a foregone conclusion. Though hardly ever stated explicitly, the understanding was that if I were indicted by a grand jury, then it was presumed I did something wrong. Under that perception, the indictment was not an opportunity to explain and defend myself, but a tragedy to accept and mourn. Any attempt to fight the inevitable was considered merely a stage in the grieving process.

I felt trapped and manipulated, my ability to defend myself weakened as my legal options dwindled to nothing but inaction. I felt defiance and disgust that my identity, as a physician, as a person, could so quickly give way to extremism engulfed and defined me. Soon enough, any attempt to justify or rationalize was met with tacit silence, pressed lips, and expressive eyes balancing sorrow and condemnation. Perception became my harsh new reality, defined by the prosecutor, who selectively created the impressions needed to obtain his desired outcome.

The prosecutor obtained a grand jury indictment by focusing publicly and overtly on the undercover agent’s visits as well as the actions and perjured statements of my medical assistant. To coerce a plea agreement, he impressed upon me directly and covertly the regulatory violations of the collaborative agreements I had used in the patient transitions. He claimed the regulatory policies could be considered criminal, and that he would superimpose additional charges if I were not to plead guilty.

Two separate legal strategies, one public, the other private, one to indict, the other to convict through plea—this was the prosecutor’s desired intent from the outset. The pressure to enter into a plea bargain grew heavier with every article, every motion, every misrepresentation gone unchecked, and every legal interpretation twisted and perpetuated, until I stagnated into a state of helplessness, weighing whatever limited options I had left.

After my indictment, I thought, naively, that I could resolve the matter like I had resolved other issues in my clinic, through open and honest communication. I called the police station, where I had been detained, to schedule a meeting to speak with the Munster police officer leading their opioid awareness initiatives. Surprisingly, he invited me to meet later that day.

We discussed the clinic, the quality model, strategies for patient care, and opportunities for physicians and police officers to work together in managing high-risk patients. We spent a significant amount of time discussing how trust in the clinical setting is essential for high-quality, cost-effective medicine. The meeting went well, and the officer invited me to future community events. I left the meeting, feeling content, decidedly confident that the officer had the right impression of me.

Then my phone rang.

My attorney blasted me for doing something apparently so reckless, so foolhardy, that to the interpretive eyes of the prosecutor must have been an attempt to manipulate the police to my advantage. I quickly realized there were no upcoming events or collaborations; there was only the legal case and its interpretations. From then on, I knew the die had been cast. The stain of criminality had left an indelible impression that could never be removed as long as the legal proceedings went on.

At that point, defiance became delusion, and I was left with no legal recourse and no ability to speak the truth. I stopped fighting. Anger became arrogance, so I stopped getting angry. Sadness gave way to acceptance, and I agreed to accept the plea agreement.

My eyes grew heavy under a lingering shame that overtook my face whenever I looked at my wife and now six-month-old son, feeling the sorrow of unconditional support in every broken smile.

My mind never agreed to what my hand eventually signed. I never believed I’d committed a crime over the course of patient care, and to be honest, I believe I was entrapped. Entrapment consists of two parts: inducement and predisposition. Inducement is when law enforcement directly forces a person to commit a crime, and predisposition is when the government influences a person to behave out of character, thereby committing a crime. How is this anything but an attempt to induce me into a crime? When no crime could be induced, law enforcement imposed intense pressure that led to administrative oversights in the collaborative agreements.

I provided good care to a patient who claimed to have a history of leg pain and behaved as if he were a compliant patient. He was agreeable to lowering his pain medication and to imaging studies once his insurance coverage was activated. This led me to believe he was a patient with legitimate medical issues.

The prosecutor argued that prescribing any opioid medication was illegal, and that by trusting the patient, I violated the law by violating my duty as a physician. He cited the phrase that represents a physician’s civic duty: “Do no harm.” Prosecutors and DEA agents take this phrase and interpret it to mean any prescription they believe is medically unnecessary is immediately illegal, regardless of context. In my case, they used the phrase to imply that I blindly trusted an undercover agent by prescribing medication based on his presenting symptoms rather than requiring verification before prescribing any medication. They turned my trust of a patient into a criminal act.

Blind trust is irresponsible and simply bad medicine. However, so is immediately distrusting and requiring the patient to verify medical conditions before treatment is administered. In finding a balance in trusting and verifying, I performed my duty to someone I had every reason to believe had legitimate medical conditions.

I believe I chose the right balance of verification and trust. I believe I was induced. But what I believe matters less than what they interpreted. And that made all the difference.

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We Need New Laws To Protect People in Pain

https://reason.com/2023/02/14/we-need-new-laws-to-protect-people-in-pain/

The CDC’s revised prescribing guidelines retain an anti-opioid bias and do nothing to reverse the harmful policies inspired by the 2016 version.

“I hope I will remain alive for 2023 to see changes in pain control,” a woman I’ll call Nancy H. says in a recent email. “I have been treated with opioids for over 25 years at the pain management center of a world-renowned hospital in Boston. I now am suffering daily because I was force tapered down from 150 milligrams of oxycontin and 60 milligrams of oxycodone per day…to just 60 milligrams of oxycodone.”

As a health care writer and advocate for people living with chronic pain, I get a lot of messages like this one. They reflect the experiences of patients suffering the consequences of opioid prescribing guidelines that the Centers for Disease Control and Prevention (CDC) published in 2016. Those consequences include sharp reductions in medication, undertreatment of pain, reduced access to care, and outright abandonment of patients, resulting in needless suffering and sometimes suicide.

The horrifying fallout from the CDC’s 2016 recommendations, which inspired laws, regulations, policies, and practices aimed at reducing the medical use of opioids, was obvious to patients, pain experts, and the American Medical Association. It attracted attention from the Food and Drug Administration and ultimately prompted the CDC to issue new, supposedly improved guidelines in 2022.

The revised version implicitly acknowledges the damage done by what the CDC describes as “misapplication” of its advice. But the agency’s updated recommendations retain a bias against treating pain with opioids and a preoccupation with arbitrary dose limits. They do little to address doctors’ fears of regulatory or criminal sanctions, and they do nothing to reverse the misguided rules that legislators, regulators, insurers, pharmacists, and health care organizations adopted in response to the 2016 guidelines. A real course correction will require new legislation, which starts with recognizing how those rules have harmed patients like Nancy H.

“Utter Madness”

“The pain and other withdrawal symptoms from this forced taper are horrifying, and the pain I suffer is unrelenting,” Nancy H. writes. “My pain management physician did NOT want to taper me and other patients off of the amounts we were being prescribed. The hospital board mandated that all patients being treated for noncancer pain were to be tapered down to 60 milligrams. My physician and other physicians at the pain clinic were told that they would be fired if they did not taper every patient to 60 milligrams.”

According to the scientifically dubious conversion system used by the CDC, that daily dose of oxycodone corresponds to 90 “morphine milligram equivalents” (MME), a threshold that the 2016 guidelines warned doctors against crossing. The 2022 guidelines omit that recommendation but include a warning that is potentially even more damaging.

“Before increasing total opioid dosage to ≥50 MME/day,” the CDC says, “clinicians should pause, considering that dosage increases to >50 MME/day are unlikely to provide substantially improved pain control for most patients while overdose risk increases with dosage, and carefully reassess evidence of benefits and risks.” Although this daunting advice implies that daily doses exceeding 50 MME are rarely appropriate, millions of patients have been well served by opioid therapy at much higher doses, often for years without negative outcomes.

The 2016 guidelines did not say patients who already exceeded the 90-MME threshold should be forced to get by with less. But that is how the guidelines have been widely interpreted, as illustrated by Nancy H.’s account, which is similar to numerous reports on social media. “Along with so many chronic pain patients,” she says, “I have given up any hope that I will ever receive the pain management treatment that is necessary to have some quality of life.”

The 2016 guidelines, like the revised version published last year, were not supposed to affect cancer patients or end-of-life care. But they contributed to an anti-opioid culture that resulted in shocking maltreatment of patients on their deathbeds.

“My husband, who just died of brain cancer, spent many of his last days in agony,” Rhonda F. reports in a January 2023 email. “I had to fight for him to receive any pain relief. Yes, a wonderful man with terminal brain cancer was forced to suffer. I asked the doctor why nobody was giving Larry pain relief, and he replied, ‘They are all afraid for their licenses.’ My poor, dying husband would moan, lifting his hand to his head, and cry. This is complete and utter madness.”

One Size Does Not Fit All

The madness began with the conviction that pain relievers prescribed by doctors—even for bona fide patients—caused and sustained the “opioid crisis.” But the correlation between opioid prescribing and drug-related deaths that the CDC cited in its 2016 guidelines was no longer apparent after 2010. The 2022 revisions nevertheless falsely assert the same connection, relying on outdated numbers to support the belief that curtailing prescriptions will somehow reduce opioid-related deaths, which nowadays overwhelmingly involve illicit fentanyl.

Meanwhile, at least 40 percent of all U.S. community clinics are refusing to accept new patients for pain management. Many pain patients dropped by their doctors cannot find anyone to continue their care.

The 2022 guidelines say nonopioid therapies are “preferable” for most patients. But medical literature does not support that recommendation, especially for severe pain. No published trials directly compare opioid therapy with nonpharmacological treatments on an either-or basis. When used to supplement pain relievers, alternative treatments such as acupuncture, physical therapy, and counseling offer only marginal and temporary improvements in pain or quality of life. While prescription opioid therapy is not a default first option for all patients, it is indispensable for both acute and chronic severe pain when the alternatives are less effective.  

Like the 2016 guidelines, the new version completely ignores genetic variations in drug sensitivity between individuals. Because of those differences, which have been recognized for at least 20 years, the minimum effective dose is estimated to be as much as 15 times higher for some patients than for others with similar conditions. But published medical trials do not address this wide variability, and neither do the CDC’s one-size-fits-all practice standards. 

The CDC says its guidelines “should not be applied as inflexible standards of care across patient populations.” But the CDC’s bias against opioid therapy in general and against high-dose therapy in particular, which is based on an exaggerated depiction of the risks it entails, belies that stance.

It seems clear that we cannot rely on the CDC to correct its errors. But state and federal policy makers can take steps to ameliorate the harm caused by ham-handed efforts to reduce the medical use of opioids.

What Legislators Can Do

Clinicians need an evidence-based standard of practice for prescribing opioid analgesics, and they need to be confident that following that standard will protect them from criminal prosecution, regulatory sanctions, and institutional penalties. Such guidance would necessarily replace the CDC’s recommendations, and federal legislation may be necessary to stop the agency from presuming to tell doctors how to practice medicine.

Six U.S. medical organizations have urged an end to “political interference in the delivery of evidence based medicine.” These organizations represent more than 500,000 frontline clinicians and medical students spanning family practice, internal medicine, obstetrics/gynecology, osteopathic medicine, pediatrics, and psychiatry. Additional specialties are represented in the American Medical Association’s Substance Use and Pain Care Task Force, which aims to “promote evidence-based policy to end the epidemic of deaths related to drug overdose.”   

A truly balanced practice guideline could be developed by a committee of clinicians who actually practice pain management in communities or hospitals, with representation from clinical specialty academies and organizations. Like the Inter-Agency Task Force on Best Practices in Pain Management that the U.S. Department of Health and Human Services established in 2019, such a committee should also include chronic pain patients and their advocates as voting members. 

The committee’s work should start with a few basic principles. Treatment begins with a cooperative, face-to-face relationship between patient and physician. It includes documenting therapy plans, monitoring progress, tailoring treatment to the individual, and educating patients and family caregivers. Doctors and patients should understand the difference between addiction—a compulsive attachment that persists despite identifiable harms—and physical dependence, which involves withdrawal symptoms following abrupt cessation. Clinicians also must recognize that forced tapering of stable patients is never ethically appropriate and may risk patients’ lives. 

Pending completion of that project, Congress should require the CDC to withdraw its pain treatment recommendations and notify state medical boards that they should not rely on those guidelines in regulations or practice standards. Congress also should repeal Sections 131 and 133 of the 2018 Veterans Affairs Mission Act, which aim to reduce opioid prescribing throughout the V.A. system, based on the same mistaken premises as the 2016 CDC guidelines.  It should direct the V.A. to withdraw its Opioid Safety Initiative and the clinical practice guidelines associated with it, which have been used to justify blanket denial of opioid therapy to veterans. 

The Controlled Substances Act, which the Drug Enforcement Administration (DEA) has long deployed against physicians whose prescriptions it deemed medically inappropriate, is another barrier to pain treatment. Last year in Ruan v. United States, the Supreme Court may have reduced that threat by ruling that doctors can be convicted of drug trafficking only if they “knowingly or intentionally” violate accepted standards for medical use of controlled substances.

Amending the Controlled Substances Act could provide further protection for physicians who worry that their good-faith prescribing decisions might jeopardize their liberty, licenses, and livelihoods. Clinical staffs should no longer be subject to coercion by DEA agents who threaten prosecution to obtain testimony against clinicians. Congress should also curtail pretrial asset forfeiture, which often denies clinicians the resources they need to defend themselves effectively in court. 

Several states, including New Hampshire, Rhode Island, Oklahoma, Arizona, and Minnesota, have already enacted reforms aimed at protecting clinicians from inappropriate sanctions. These laws are designed to prevent medical boards and law enforcement agencies from penalizing or prosecuting clinicians for “appropriately” prescribing opioids within a “current standard of care.” No one should look to the CDC for that standard.

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