A fairly visible chronic pain advocate just re-posted a video she did abt four years ago about another chronic painer who had her pain management reduced, given the date on the video would suggest that happened sometime after the 2016 CDC guidelines published and the 2019 posted date on the video.  Apparently this pt over that 2-3 yr period had suffered FIVE HEART ATTACKS with the 5th one being FATAL.

The CSA was signed into law in 1970, the same year I was first licensed as a Pharmacist. So I  have had a front row seat to its evolution over the years. That created the BNDD ( Bureau of Narcotics & Dangerous Drugs) which created the bureaucratic foundation for when in 1973 Congress created the DEA with 1200 employees and a 42-43 million/yr budget.

Most of the active Heroin addicts was in the NY area and the mafia was the primary supplier of Heroin. During the 80’s the DEA/law enforcement got more and more creative with Civil Asset Forfeiture seizure and since the mafia and their assets were USA based and a good target for the DEA/law enforcement.

It would appear that the mafia gave up on the illegal Heroin distribution and apparently the Mexican cartels moved in to pick up the distribution of Heroin.  Since the Cartels’ assets were outside of the DEA jurisdiction, confiscating the Cartel’s assets proved a challenge. All the assets the DEA had previously confiscated, they were able to put them into the DEA’s coffers… to spend as they wished.

In 2000, our Congress passed the DECADE OF PAIN LAW, that encouraged ALL DOCTORS to treat pain.  the FIFTH VITAL SIGN was created and the Joint Commission made it a MAJOR STANDARD for hospitals to meet.  Pt discharge questionnaires included if/how the pt’s pain was treated. The number of Rx prescribed during the decade and when the bill was up for renewal, the political party in charge of Congress when it was passed was no longer in the majority and the law was not renewed.

Rx opiates filled peaked in 2011-2012.  In Jan 2009, we have a new President (Obama) in office and in 2011 FL gets a new Governor Rich Scott and a new state AG Pam Bondy.  Florida had become a major source of opiate prescribing, mostly because they had a “loose licensing system” and they did not have a state wide PDMP.

The Decade of pain law – in essence – created a lot of “low hanging fruit” for the DEA to go after – prescribers who were following the Decade of Pain law and as DEA was losing MJ as states were making MJ legal in many states. which was a “cash cow” for the DEA.  The Decade  of pain law disappeared and FL implemented a PDMP and AG Bondy what she called “oxy docs” and according to her re-election campaign ads she chased out 200 oxy docs from FL in her first 4 years.

The first blog post on my blog was June 2012. In the ensuing 10 yrs, yes chronic pain pts have died. Especially after the 2016 CDC guidelines were published. What was put on their death certificate ?  Opiate related death because there was some record of them receiving a Rx opiate, or they committed suicide using their own meds ?  Was it because of “natural causes”, because their blood pressure spiked and they had a stroke, heart attack, ruptured aortic aneurysm.  Maybe a GI bleed or kidney failure because of the excessive use of a NSAID  or excessive use of Tylenol/Acetaminophen and liver failure.

How many petitions have been published ? Has anyone see any action because of those petitions ?  How many letters, phone calls, faxes, emails, in person meetings has there been with members of Congress ?  How many responses/letters focused on the problems with the war on drugs and little/nothing about the context of the original communication ?

The 2016 CDC guidelines, they tried to have them created behind closed doors, with anonymous committee members and no public comment.  They didn’t follow the statutory requirements – any consequences to CDC/anyone ?

The 2022 CDC guidelines, how many comments from the community, how many comments were read, some claim that many comments “disappeared”.  Was there any changes from the proposed 2022 guidelines and those that were published as FINAL ?

Recently, Walgreen, CVS, Walmart agreed/settled to a combined 13.8 billion settlement for contributing to the opioid crisis and as I remember within the settlement they are agreed to FILL FEWER OPIOID Rxs.

J&J was found guilty of being a “PUBLIC NUISANCE” and a 572 million settlement for being the wholesaler of raw opioid powder to the pharma industry to produce FDA approved Rx meds – it was overturn later.  Teva agreed to a 4.25 billion settlement to untold number of “wronged parties” and contributed to the opioid crisis.

I has not been until the last year or so that it has came to light some of the shenanigans that federal prosecutors and federal judges will pull to help assure a conviction. I now understand why I have numerous attorneys have claimed that 90%+ of those taken to federal court – are found GUILTY !

Here is a letter from Kaiser from 2019 from their “medical clinic team” that they are limiting opioid Rx to < 50 MME, most/all below the FDA’s recommended max daily dosing.  The MME system that  has no science nor double blind clinical studies supporting its conclusion.  https://www.acsh.org/news/2022/03/01/true-story-morphine-milligram-equivalents-mme-16154  they are also using a “broad brush” to prohibit the concurrent prescribing of 4 different categories of FDA approved meds as safe for human use. ( Opioids, benzos, muscle relaxants & sleeping meds)

Since the letter by “medical clinic team”  and it is on Kaiser’s letter head, one can only presume that this committee’s decision is supported by the BOD of Kaiser.

One of the core functions of the practice of medicine is the starting, changing, stopping a pt’s therapy. So is Kaiser limiting/restricting the professional discretion and prescriptive authority that is granted each prescriber by their state medical license.

In 2021 https://www.statista.com/statistics/401547/kaiser-permanente-members/ it is reported that Kaiser had 12.6 million members. If one uses the low end figure of 20% chronic painers in our general populations.  That would suggest that this policy could impact up top 2.5 million pts.

This is just one of a unknown number of large heath care corp doing the same/similar thing and that is not counting the number of chain pharmacies and insurance/PBM corporations doing same/similar thing.

Law firms like to find large corporations – with deep pockets – that has harmed people and the more “bodies” the better. To start a class action by a law firm only needs 1-2 lead plaintiffs.  All it is going to take is 1 or 2 chronic pain pt reaching out to a law firm that deals with civil rights violations that a interest to investigate

To date, all those chronic pain pts that are suffering from under/untreated pain or have died is doing so because of laws & illegal guidelines that have been used against them. The only way that the chronic pain has a chance to get their appropriate pain management back is using the laws that these corporations are using against them and/or laws they are breaking.

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There has been all too many dictators/groups- over many centuries – that have targeted certain groups because they were deemed unequal, unholy or doesn’t “fit in” with what some believe is representative of what a particular societal population should be.

Annually, there is a huge meeting in DAVOS, https://news.yahoo.com/davos-2023-key-takeaways-world-153551754.html where financially and politically important people fly their fuel guzzling jet planes and discuss how our plant is going to hell in a hand basket and how they can help save our planet. I heard that one of those “big shots” made a comment that our planet  is grossly populated and we need to get rid of 50% of the planet’s population. Current world’s population is abt 8 BILLION and each time each of exhales we are adding CO2 to our atmosphere, that is suppose to be harming our plant.

Here is a bureaucrat in MASS made the suggestion that “defective fetus in the womb” should be aborted because they are will be a financial burden on the various school systems. The vary definition of eugenics.

His mindset seem to mirror the mind set of certain other segment of other bureaucrats… when they seem to be “targeting” high acuity disabled pts that are consider a financial burden  on our healthcare system.

Congress has passed at least two laws – Americans with Disability Act & Civil Rights Act – that is supposed to prevent disabled people from being discriminated against. Unfortunately, the agency – within the DOJ – that is suppose to enforce those laws has mostly chosen to tell those to attempt to file a civil rights discrimination complaint, are told that they don’t have the resources to pursue such complaints.

While another agency under the DOJ – is the primary source of causing those civil rights discrimination to happen with their FIVE DECADE war on drugs.  In many minds, the DEA actions in fighting the war on drugs is a direct/indirect cause of a COVERT GENOCIDE. Opioid Rxs peaked in 2011-2012 and today pharma opioid production is down abt 60% as is the filled Opioid Rxs. The number  of Opioid OD’s is UP abt SEVEN TIMES – mostly from illegal fentanyl coming from China & Mexico and yet we keep funneling over 100 billion/yr into the DEA to fight the war on drugs.

I guess the only people who would think that after FIVE DECADES and over TWO TRILLION spent on our war on drugs has been a success is those whose paycheck comes from that TWO TRILLION we have spent. Isn’t the House of Representatives suppose to be in charge of the “federal purse stings” ? there is 435 members in the House, is there NO ADULTS IN THE HOUSE ?

Massachusetts Democrat told to step down after abortion comments leave parents irate

https://www.foxnews.com/politics/massachusetts-democrat-told-step-down-abortion-comments-leave-parents-irate

‘This is eugenics in 2023 America,’ says Students for Life President Kristan Hawkins

FRAMINGHAM, Mass. – A local Democrat official in Massachusetts is facing calls to step down after complaining about the cost of special education for children with disabilities who are not aborted.

Michael Hugo, the chair of the Framingham Democratic Committee, made the remarks during a city council meeting when discussing a proclamation about access to abortion and crisis pregnancy centers in the city. He said crisis pregnancy centers could misdiagnose a defect in a baby in the womb, leading to them being born and becoming a strain on a school budget. He issued a public apology after 10 days of backlash from members of his own party and parents of special needs children.

“I saw what Michael had said as a personal attack against my own children,” said Sheryl Goldstein, the chair of the Framingham Disabilities Commission. “That my children who had special needs were not worth the expense in the school system.”

MASSACHUSETTS DEMOCRAT TOLD TO RESIGN AFTER ABORTION REMARKS LEAVE PARENTS IRATE

Video

In his public apology letter, Hugo called his comments “offensive and hurtful.”

“I am writing to offer my most sincere and humble apology to members of the Framingham Democratic Committee, but more especially my fellow members of Framingham’s disability family community, for comments that I made at the last City Council meeting which were offensive and hurtful,” he wrote. 

He said members of the committee did not “see or review” his remarks despite being sent out the night before the meeting. 

“Our fear is that if an unqualified sonographer misdiagnoses a heart defect, an organ defect, spina bifida or an encephalopathic defect that becomes a very local issue because our school budget will have to absorb the cost of a child in special education, supplying lots and lots of special services to children, who were born with the defect,” Hugo said at the Feb. 7 meeting.

Laura Green, a disability advocate in Framingham told Fox News that she does not accept his apology.

“I feel that it was generic and lackluster. I feel like after a statement like that is made, you can’t just pretend that it didn’t happen or take it back because it’s damaging to a community of people,” she said. “The disability community is the only minority group that you can become a part of at any time.” 

Crisis pregnancy centers provide ultrasounds to pregnant women for little to no cost. (iStock)

According to his LinkedIn, Hugo is also the director of policy and government affairs for the Massachusetts Association of Health Boards. 

MA REPUBLICAN GOVERNOR CHARLES BAKER SIGNS BILL PROTECTING ABORTION RIGHTS

Jon Fetherston, a special needs advocate and registered Republican said he was in disbelief when he heard the comments. 

“As a parent of an autistic child, I read those comments and go ‘what?’” he said. “A peer of mine thinks that I should’ve aborted my child because he was going to be a burden to a school budget?”

Kristan Hawkins, the mother of two children with cystic fibrosis and the president of Students for Life told Fox News she was deeply offended by Hugo’s comments. 

“This is discrimination plain and simple,” she said. “I think people who say that the sick cost too much for our society better find the fountain of youth real quick because someday that’s going to be them, it’s going to be their family members.”

“This is eugenics, this is eugenics in 2023 America, this is an argument that sadly we’ve heard before and throughout American history, just regurgitated using a bunch of fancy lingo or support for abortion,” Hawkins added.

Laura Green says her best friend with down syndrome inspired her to be a disability advocate. (Laura Green)

In his speech, Hugo said he was “speaking on behalf of the Framingham Democratic Committee,” adding that it’s their mission to “work for the common good by promoting racial, ethnic, social, and economic equality for the people of Framingham.”

NATIONAL ARCHIVES CUTS TIES WITH GUARD WHO TOLD VISITORS TO REMOVE CLOTHING WITH PRO-LIFE MESSAGES: REPORT

“It’s astounding to see such a heartless statement, especially coming from 2023 America where we’re supposed to be this progressive inclusive society that celebrates diversity, come out and say ‘well yeah certain people shouldn’t be born because they’re going to cost us too much money,” Hawkins said.

A speaker that came shortly after Hugo at the meeting denounced him and said he went “off the rails.”

“I’m a lifetime member of the Democratic Committee, and the person who wanted to represent us went off the rails on a different direction that was never brought before the Democratic Committee,” said Pat Dunne, a former Framingham School Committee member, according to Framingham Source. “We’re not talking about eliminating special education students and the like. We’re talking about getting out good information to the people in Framingham. And he’s casting a bit too wide for me and that’s why I did want to say something.”

In a letter sent to city council members several hours before the meeting and obtained by Fox News, Hugo provided a preview of his remarks reported to the Source, asking if the state will “cover the medical costs for a fetus that had sound medical reason to be terminated.”

He questioned if the state would “cover the costs of special education for a down syndrome affected child” and “pay for the extraordinary medical expense of a child with an atrial septal defect?”

“How much does Framingham’s Public School Department pay for unreimbursed special needs school transportation, specialized education and durable supplies?” he asked. 

Hugo also claimed crisis pregnancy centers’ sonographers would likely misdiagnose defects “while proclaiming that it is a beautiful child living inside the mother and handing her an ultrasound photo that nobody can figure out without training, some diapers and a couple of ‘onesies’ for her new baby.” 

Hugo said he and others are working to prevent pro-life crisis pregnancy centers from opening up in Framingham.

Michael Hugo, a local democratic official in Framingham, MA questioned the costs of children with down syndrome on his city who are not aborted. (BSIP/Universal Images Group via Getty Images)

Hawkins disputed Hugo’s complaints about crisis pregnancy centers.

PRO-LIFE GROUPS SOUND ALARM ON OHIO ABORTION BALLOT PROPOSAL THEY SAY WILL ‘CANCEL THE RIGHTS OF PARENTS’

“Pregnancy care centers offer such excellent free services that even the abortion-supporting community has taken note,” she said. “Preventing young mothers from getting free services is a sign that the abortion mindset has poisoned far too many in our culture.” 

Goldstein added that due to her leadership position with the disabilities commission, she has received many calls and texts from families with special needs children in the community.

“People are quite frankly very upset,” she said “They want action.”

“I saw what Michael had said as a personal attack against my own children,” said Sheryl Goldstein, the chair of the Framingham Disabilities Commission.  (Sheryl Goldstein)

The Framingham Democratic Committee echoed Hugo’s apology in a statement issued last week, claiming his remarks did not reflect the full committee, adding “we fully disavow and denounce them.”

“If they disavow and do not support those comments, how do you leave him in charge of your organization?” Fetherston who has a child with autism asked. “He has an influential position inside the party and if he even thinks that, much less says it in a public meeting, then he shouldn’t be in a leadership position.”

“I think he should immediately step down,” Fetherston added.

Hawkins said that while she believes Hugo should be removed, his blunt comments “hopefully woke up a lot of people to their support of abortion.”

Neither Hugo nor the Framingham Democratic Committee responded to Fox News’ request for comment.

To learn more about the backlash to Hugo, click here.

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Apparently by the date on this letter Kaiser JUMPED THE GUN on the CDC 2022 guidelines and they are referencing the MME system which has no science nor double blind clinical studies supporting its conclusions https://www.acsh.org/news/2022/03/01/true-story-morphine-milligram-equivalents-mme-16154 Looks like Kaiser is practicing medicine by COMMITTEE. I know that the Controlled Substance Act states that no one can prescribe a controlled substance without doing in person exam. And from the second picture, it appears that they have created a “corporate “cookie cutter” treating pain ” book.

I am sure that most of their employee prescribers are ecstatic that Kaiser has taken away their prescriptive authority and professional discretion that they were granted by the state medical license.

Obviously, Kaiser is following the DEA’s opinion of how many subjective diseases should be treated, based on DEA’s observations and opinions of how those people with mental health issues and are considered addicts and the “medical expertise” that the DEA has come to the conclusion by those observations of what drugs addicts take/consume.. disregarding how many tabs/caps/mgs of each are taken at one time.  Which has nothing to do with how they would be prescribed to a pt with valid medical necessity.

It has been my experience that many high acuity pain pts are dealing with multiple pain generating medical issues and often will benefit from having one or all four of meds that Kaiser has declared cannot be prescribed concurrently.  Most of these pts are probably considered DISABLED. Isn’t disabled people protected under the Americans with Disability Act & Civil Rights from being discriminated against ?  Could a corporate edict that certain categories of medications cannot be concurrently be prescribed to a pt that has multiple high acuity health issues whose QOL could be improved … if they were appropriately prescribed one or more of  meds in those categories and any person or entity denying the appropriate medications concurrently… actually be discriminating against them and a civil rights violation of those laws that protect disabled pts.  Kaiser has to have tens of thousands of such pts.  I guess that it would take a law firm that deals with civil rights discrimination issues to figure that out.

Here are a few posts from past post on my blog concerning Kaiser and how they are treating chronic pain pts..these are for 2018 & 2019

Yesterday Kaiser Permanente signed my death warrant

Dying Cancer patient denied Opioids by Kaiser

Kaiser Permanente and the End of Compassionate Care

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Canadian panel pushes assisted suicide for minors without parental consent

https://www.foxnews.com/media/canadian-panel-pushes-assisted-suicide-minors-parental-consent

Canada’s Special Joint Committee on Medical Assistance in Dying recommending allowing euthanasia for some minors

Canada’s Special Joint Committee on Medical Assistance in Dying (MAID) recommended assisted suicide for minors without parental consent in mid-February.

A 138-page Canadian Parliament document was shared online called, “Medical Assistance In Dying In Canada: Choices or Canadians.” One part of the report addressed assisted suicide options for “mature” minors in Canada. They considered two tracks, one for whom there is “reasonably foreseeable” death, the second track for those for whom “mental disorder is the sole underlying medical condition.”

The government document explained the debate among government witnesses about expanding assisted suicide to those who are not yet legal adults.

“For MAID and mature minors, the committee heard a mix of views about whether MAID should be available to those under the age of 18. Many witnesses believed that age alone does not determine whether someone is capable of consenting to MAID,” the document’s authors wrote. “At the same time, a cautious approach was recommended, especially since there is little evidence from youth themselves on this topic.”

In 2014, Quebec reported enacted legislation for “end-of-life care,” which includes rules relating to “medical aid in dying.” (iStock)

CANADIAN SOLDIER SUFFERING WITH PTSD OFFERED EUTHANASIA BY VETERANS AFFAIRS

While the paper ultimately did not recommend MAID for children who are mentally ill, “The committee agrees with the many witnesses who opined that MAID for mature minors should be limited to track one [reasonably foreseeable natural death] at this stage, especially given the lack of youth perspectives on the topic.”

Among a list of recommendations was a suggestion that “That the Government of Canada restrict MAID for mature minors to those whose natural death is reasonably foreseeable.”

One critical aspect was that while the government committee supported the concept of consulting parents about administering euthanasia, children would have the final say: “The committee agrees with those witnesses who supported a requirement for parental consultation, but not consent, in the context of MAID for mature minors.”

Judging assisted suicide. (iStock)

One recommendation the committee gave was to formalize this idea into law.

“That the Government of Canada establish a requirement that, where appropriate, the parents or guardians of a mature minor be consulted in the course of the assessment process for MAID, but that the will of a minor who is found to have the requisite decision-making capacity ultimately take priority,” the committee advised.

The Daily Mail, after noting children would be “joining the roughly 10,000 adults who end their lives each year by state-sanctioned euthanasia in Canada, quoted multiple critics of the proposal.

“I think it’s horrible,” Amy Hasbrouck, of the anti-MAID group, Not Dead Yet, told the outlet. “Teenagers are not in a good position to judge whether to commit suicide or not. Any teenagers with a disability, who’s constantly told their life is useless and pitiful, will be depressed, and of course they’re going to want to die.”

Multiple activists from organizations concerned about government-assisted suicide condemned the committee’s recommendations for minors. (iStock)

Executive director of the Euthanasia Prevention Coalition Alex Schadenberg told the Daily Mail, “We said we were going to have safeguards and guardrails, but the next government can simply open it up further by making a decision — and that’s exactly what’s happening.”

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For those of you who keep talking about suing the Federal Government/DEA – here is how you can sue the government BUT YOU WILL NOT GET PAST FIRST BASE…  the federal government has this “wild card” that they can use to get any case dismissed they want to. It is called sovereign immunity and basically it means that the FEDS can only be sued, when they agree to be sued.

Given the financial resources of Walmart, if any other individual or advocacy group thinks that they could be successful in suing the Feds/DEA… go for it.. but don’t expect any law firm to do it on a contingency basis.

Walmart lawsuit against U.S. over opioids is dismissed

https://www.reuters.com/business/walmart-lawsuit-against-us-over-opioids-is-dismissed-2021-02-05/

Feb 5 (Reuters) – A federal judge has dismissed Walmart Inc’s (WMT.N)lawsuit seeking to preemptively block the U.S. government from blaming the world’s largest retailer for its alleged role in fueling the nation’s opioid crisis.

U.S. District Judge Sean Jordan said the government had not waived its sovereign immunity from Walmart’s “sweeping” challenge to the Department of Justice’s and Drug Enforcement Administration’s enforcement of laws governing opioid prescriptions by pharmacies and pharmacists.

Walmart said on Friday it will appeal the decision, which the Plano, Texas-based judge issued on Thursday night.

In its Oct. 22 lawsuit, Walmart had said the government’s lax and confusing oversight left pharmacists with an “untenable” choice between filling prescriptions and risking criminal or civil liability, or refusing prescriptions and facing the wrath of patients, doctors and state medical boards.

“Our pharmacists and patients deserve better than the current patchwork of inconsistent, conflicting and contradictory demands from federal and state regulators,” the Bentonville, Arkansas-based retailer said in announcing the planned appeal.

The Justice Department’s lawsuit against Walmart was a significant escalation of its efforts to hold major pharmacies responsible for their roles in an U.S. opioid epidemic in which about 450,000 people died from overdoses from 1999 to 2018.

It is seeking civil damages for Walmart’s alleged violations of the Controlled Substances Act on a “nationwide scale,” both as a pharmacy and as a distributor.

Filed under: General Problems | 2 Comments »

Every time that I sit down at my desk, I am reminded of a couple of movies GROUND HOG DAY and ALICE IN WONDERLAND

Because I seem to go down the same RABBIT HOLE and I keep  giving out the same advice I have posted perhaps hundreds of times before.

I have read where some major chronic pain advocates have stepped back from advocating and some others are talking about stepping back.

Nearly every day I hear or read on various medias the use of the words EQUALITY, EQUITY, INCLUSION, but none of those words apply to the estimated 100 million chronic pain pts. However, people who are abusing and/or addicted to legal & illegal opiates are getting more and more inclusion and equity.

Historically I have seen/heard the quote often used in regards to federal grand juries that “they could indict a ham sandwich”, but I have seen some quotes from prosecutors in grand jury hearing and a highly qualified chronic pain prescriber could be indicted… here is a reported quote from a recent grand jury hearing on such a physician  “The prosecutor argued that prescribing any opioid medication was illegal”

When you dissect that prosecutor’s statement, all opiate prescribing is ILLEGAL… because there are no pts that have a valid medical necessity for being prescribed a opiate – THERE ARE NO VALID CHRONIC PAIN PTS !!

All Chronic Pain Pts need to understand certain FACTS:

All of the media is in lock step with the DEA and their agenda. Here is the DEA website with all their press releases https://www.dea.gov/what-we-do/news/press-releases  By and large, the media just regurgitates these press releases and never tries to clarify nor verify their accuracy.

Typically 40% of the members of Congress are attorneys, they are never going to muzzle the DEA

Here is a article that just dropped into my inbox as I was composing this blog post.  If the AMA is having trouble lobbying Congress….

‘Advocacy Is Hard, and Washington Is a Difficult Place’

— AMA president Jack Resneck Jr., MD, opens up about his challenges and successes so far

You CAN’T sue the government, if have a few million dollars lying around you could challenge the constitutionality of the CSA in our court system.

Suing a doctor over malpractice is a lose-lose, many states have limits on malpractice awards, that even if the plaintiff wins, all legal fees will not be covered.

Recently I was informed that two major MCO ( Managed Care Organizations) that operate in 9 states & DC.. have implemented a no opiate or near no opiate policies for pts. Law firms like large corporations with “deep pockets” that have done harm to people.. the more “bodies” the better. Most of those chronic pain pts are considered disabled and a covered entity under American with Disability Act & Civil Rights Act. The MCO putting out a corporate edict that their employee prescribers are not allowed to prescribe opiates for chronic painers.

Most would consider one of the core functions of the practice of medicine is the starting, changing, stopping a pt’s therapy.  I am not aware of any corporation that has a medical degree nor a license to practice medicine.

My money is on that there is at least one MCO in each state doing same,similar things with no opiate prescribing to chronic pain pts.  How many tens of millions of chronic pain pts are suffering because of these corporate edicts ?

here is a chart of possible complications to a pt’s comorbidity issues from under/untreated pain.

All it takes is one or two lead plaintiff in a class action.  But, get off of being a “keyboard warrior” and find a law firm that deals with civil rights violations and may have a interest in talking about suing some of these large MCO over civil rights discrimination, inflicting pain and suffering on tens of millions of chronic pain pts.

If you are reading this, you are probably part of the chronic pain community. If everyone in the chronic pain community is waiting for “George” to come save their ass.  Sorry, “George” is have a “bad week” and he is not going to bother !

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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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