Biden’s $125 billion investment in a comprehensive response to the opioid epidemic and substance use disorders is paid for by raising taxes on the profits of pharmaceutical corporations

Posted on February 28, 2023 by Pharmaciststeve

Biden is going to stop the opioid crisis and the addiction problem… spending 12.5 billion/yr over the next TEN YEARS…  The war on drugs is currently costing us 100+ billion/yr. So Biden expects to succeed where FIVE DECADES and TWO + TRILLION spent has not only FAILED  but seemingly MADE THINGS WORSE ! Last year the number of opioid OD/poisonings was abt SEVEN TIMES the number from TEN YEARS AGO.

This is so typical of a mid 20th century mindset … when you had a problem… you threw $$ and man hours at it.

https://joebiden.com/opioidcrisis/#

The Biden Plan to End the Opioid Crisis

THE BIDEN PLAN TO END THE OPIOID CRISIS AND ENSURE ACCESS TO EFFECTIVE TREATMENT AND RECOVERY FOR SUBSTANCE USE DISORDERS

Millions of families are impacted by the opioid crisis. It’s ravaging communities coast to coast, from New Hampshire to California. The challenge of substance use disorders is not limited to opioids. Millions of individuals are affected by misuse of other substances such as alcohol or methamphetamine. Latest estimates indicate that, in 2018, almost 68,000 Americans died from a drug overdose – almost 47,000 of which involved an opioid. And, the impacts of this crisis reverberate in our classrooms and neighborhoods, in small towns and big cities.

Biden will tackle this crisis by making sure people have access to high quality health care – including substance use disorder treatment and mental health services. That’s what Obamacare did by designating substance use disorder treatment and mental health services as essential benefits that insurers must cover, and by expanding Medicaid, the nation’s largest payer for mental health services which also plays an increasingly growing role as a payer for substance use disorder services.

But President Trump wants to repeal Obamacare, including its Medicaid expansion. Repeal would be disastrous for communities and families combating the opioid crisis. It is not realistic to think that grant money will fill the hole that eliminating Obamacare and its Medicaid expansion would create.

Step one of Biden’s plan to tackle the opioid epidemic and substance use disorders is to defeat Trump and then protect and build on Obamacare. And, Biden will pursue a comprehensive, public health approach to deal with opioid and other substance use disorders. His plan will:

  • Hold accountable big pharmaceutical companies, executives, and others responsible for their role in triggering the opioid crisis.
  • Make effective prevention, treatment, and recovery services available to all, including through a $125 billion federal investment.
  • Stop overprescribing while improving access to effective and needed pain management.
  • Reform the criminal justice system so that no one is incarcerated for drug use alone.
  • Stem the flow of illicit drugs, like fentanyl and heroin, into the United States – especially from China and Mexico.

HOLD ACCOUNTABLE BIG PHARMA COMPANIES, EXECUTIVES, AND OTHERS RESPONSIBLE FOR THEIR ROLE IN TRIGGERING THE OPIOID CRISIS 

Biden will demand accountability from pharmaceutical companies and others responsible for the opioid crisis, including manufacturers, distributors, and “pill mill operators.” Pharmaceutical executives should be held personally responsible, including criminally liable where appropriate. Specifically, Biden will:

Direct the U.S. Justice Department to make actions that spurred this crisis a top investigative and, where appropriate, civil and criminal enforcement priority. Biden will make sure the Department has all the necessary resources to complete this work. Building on the efforts of the Obama-Biden Administration, Biden will also ensure the Food and Drug Administration takes action when new information reveals harms from previously approved drugs (including the risk of diversion, or the use of drugs by an individual other than the one to whom the drug was prescribed), ensures compliance with risk mitigation strategies, and punishes drug companies for deceptive practices. And, he will appoint an Opioid Crisis Accountability Coordinator to coordinate efforts across federal agencies and support the enforcement efforts of state and local partners.

Direct the Drug Enforcement Administration (DEA) to step up its efforts to identify suspicious shipments and protect communities. Opioids distributors knowingly shipped millions of pills to towns with hundreds of residents, helping trigger the opioid epidemic. Biden will empower the DEA to stop drug shipments from pharmaceutical companies and their distributors that create risks of diversion and misuse. Biden will work with Congress to allow the DEA to act expeditiously when a pharmaceutical distributor fails to adequately monitor shipments that could pose an “imminent danger” to vulnerable communities and increase penalties for companies that fail to take action to stop suspicious shipments. In addition, Biden will direct the DEA to improve data collection on wholesalers and pharmacies, including prescribing patterns and suspicious order reports, and to disseminate its analysis to distributors to prevent problems before they become disasters. 

Ban drug manufacturers from providing payments or incentives to physicians and other prescribers. Pharmaceutical companies work hard to persuade doctors and other medical personnel to prescribe their products. These companies essentially pay providers to prescribe opioids and other drugs by, for example, paying providers to speak at or attend conferences, or consult for their companies. By banning these practices, Biden will ensure that patients’ lives do not take a backseat to doctors’ bottom lines.

Terminating pharmaceutical corporations’ tax break for advertisement spending. Drug corporations spent an estimated $6 billion in 2016 alone on prescription drug advertisements to increase their sales, a more than four-fold increase from just $1.3 billion in 1997. The American Medical Association has even expressed “concerns among physicians about the negative impact of commercially driven promotions, and the role that marketing costs play in fueling escalating drug prices.” Currently, drug corporations may count spending on these ads as a deduction to reduce the amount of taxes they owe. But taxpayers should not have to foot the bill for these ads. As President, Biden will end this tax deduction for all prescription drug ads, as proposed by Senator Jeanne Shaheen.

MAKE EFFECTIVE PREVENTION, TREATMENT, AND RECOVERY SERVICES AVAILABLE TO ALL WHO NEED THEM

Biden has long recognized and led on efforts to make clear that substance use disorders are diseases, not a lifestyle choice, and that we need to change how we talk about and treat substance use disorders to align with this fact. 

He knows that the most important step we can take to address substance use disorders is to ensure that Americans have access to affordable, high-quality health care, including treatment for mental illnesses and substance use disorder. That’s why Biden has a plan to build on the Affordable Care Act and achieve universal coverage. In addition, Biden will redouble efforts to ensure insurance companies stop discriminating against people with behavioral health conditions and instead provide the coverage for treatment of mental illness and substance use disorders that patients and families need. Congress passed a bipartisan parity law 12 years ago requiring that this discrimination stop, but the enforcement of parity has been insufficient. As Vice President, Biden championed efforts to implement the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act. As President, he will finish the job by appointing officials who will hold insurers accountable, enforcing our parity laws to the fullest extent. He will also direct federal agencies to issue guidance making clear how state officials and the public can file a complaint when their insurers – or Medicaid – are not living up to their parity obligations.

In addition, Biden will work to make sure that people experiencing substance use disorders have access to quality facilities and providers. As President, he will ensure that the new public option, Medicare, Medicaid, the Indian Health Service, the Military Health System, and the Veterans Health Administration accelerate integration of substance use disorder care into standard health care practice. Biden will double funding for community health centers and expand the supply of health care providers, for example by growing the National Health Service Corps. And, he will protect rural hospitals from payment cuts, give them the flexibility they need to remain open, and invest in telehealth so people in remote areas can still have access to mental health and substance use disorder specialists.

Finally, Biden will make sure federal funds are specifically targeted at improving access to treatment and recovery for opioid and other substance use disorders, and at preventing these disorders in the first place. As Vice President, Biden championed passage of the 21st Century Cures Act, which included $1 billion in funding for states to address the opioid epidemic. That was a down payment. To deal with the immense scope of the opioid and substance use disorder crisis, Biden will dramatically scale up the resources available, with an unprecedented investment of $125 billion over ten years. Funds will be used to:

Pursue comprehensive strategies to expand access to treatment, particularly in rural and urban communities with high rates of substance use disorders and a lack of access to substance use disorder treatment services. Biden will invest $75 billion in flexible grants to states and localities for prevention, treatment, and recovery efforts. State and local agencies will also be able to use funds to enhance data systems allowing them to better target resources to individuals and communities most in need of support. As a condition for receiving funding, grant recipients will have to provide long-term, comprehensive strategic plans that address the multifaceted nature of the substance use disorder crisis. Funds may be used to:

  • Invest in evidence-based, cost-effective prevention programs in schools and communities to reduce the development of substance use disorders.
  • Mitigate harms from opioid and other drug use, including overdoses. Local communities will be able to use the funds to implement evidence-based programs designed to stop the spread of diseases like hepatitis C and HIV, including syringe service programs, or to scale up innovative programs like the safe station initiative started in Manchester, New Hampshire, which allows those seeking help to go to fire stations in order to be connected to treatment and recovery services. 
  • Expand access to ongoing treatment and recovery services. Communities will be able to use funds to increase access to substance use disorder and mental health treatment and other services to support long-term recovery, including peer support networks and recovery coaches, and better integrate primary care and behavioral health. Recognizing the strong evidence that social supports, including family support, may have a positive impact on the treatment of HIV, Biden will support the development of family-centered models for substance use disorder treatment and recovery. 

Make Medication Assisted Treatment (MAT) available to all who need it, reaching universal access no later than 2025. MAT (also referred to as MOUD or Medications for Opioid Use Disorder) is regarded as the gold standard of care for individuals with opioid use disorder. Yet, less than 50% of substance use disorder facilities around the country offer even one of the FDA-approved medications. The 21st Century Cures Act, legislation Biden championed as Vice President, provided resources to states designed to expand access to MAT.  Biden will build on this in order to ensure universal access to MAT for all who need it, including by:

  • Providing $20 billion for grants to dramatically expand capacity to administer MAT across the country, especially in underserved areas, including establishing new facilities and developing training programs to increase the number of professionals able to administer MAT.
  • Stopping insurance companies from erecting barriers to coverage of MAT. For example, insurers have imposed “fail first” protocols which require prescribers to certify that other therapies were tried before covering MAT. Insurers also may require that physicians obtain “prior authorization” for MAT before prescribing it.   
  • Removing undue restrictions on prescribing medications for substance use disorder. For example, drugs containing buprenorphine were approved by the FDA in 2002 but a relatively small number of doctors or medical personnel are certified to prescribe them. Biden will ensure that any undue restrictions on prescribing are lifted and review methadone treatment regulations. 

Help first responders and community health providers respond to overdoses. Biden will invest $10 billion to provide local communities with the tools needed to prevent overdoses and respond to emergencies emanating from this crisis.  

  • Ensure local communities have a sufficient supply of overdose prevention drugs. Naloxone (also known as Narcan) is a medication that can reverse an opioid overdose, making it a critical tool in the fight to save lives. Biden will expand grants to states for the purchase of Naloxone to be distributed to local community actors called upon to respond to overdoses, including first responders, public health providers, and the staff at homeless shelters and public libraries. 
  • Demand that drug companies charge a fair price for overdose drugs, including Naloxone. The Biden Administration will aggressively negotiate a reduction in the drug’s price, on behalf of the federal government, and state and local communities. 
  • Support first responders. Police officers and firefighters are often the first on the scene of an overdose. Biden will ensure they are equipped not just with naloxone, but also with the mental health and resilience support anyone would need after being exposed again and again to such trauma.
  • Invest in community-based prevention programs and a major public education effort to eliminate the stigma surrounding substance use disorder treatment. Biden will invest $5 billion in community-based prevention efforts and public education initiatives including training educators to recognize the signs of mental health problems and substance use disorders and refer them to appropriate services. Funds will also support evidence-based education programs for young people on mental health and substance use disorders.

Expand the pipeline of medical personnel to treat substance use disorders. Building on legislation like the Opioid Workforce Act of 2019, Biden will work with Congress to invest $5 billion to expand medical residencies and access to education and training for medical personnel in substance use disorder diagnosis and treatment. Funding will support training for primary care providers, as well as other members of the health care team, to build an integrated system of care.

Invest in research by doubling funding for the NIH HEAL (Helping to End Addiction Long-Term) Initiative. This $10 billion investment will support efforts to improve treatments for chronic pain.

Provide targeted interventions for particular populations. Biden will invest $10 billion in efforts specifically designed to support populations with unique situations or needs. Biden will ensure a portion of this funding for state and local governments is set aside for Tribal governments. In addition to expanding veterans’ access to substance use disorder and mental health treatment, Biden will direct his Secretary of Veterans Affairs to ensure VA medical personnel are sufficiently trained in safe prescribing practices and pain treatment. Biden will call upon the public health and criminal justice systems to provide evidence-based substance use disorder treatment, including MAT, for people during their incarceration and after their release. Finally, Biden will expand investments to help children suffering from Neonatal Abstinence Syndrome or Neonatal Opioid Withdrawal Syndrome, and to ensure their mothers have access to effective treatment and care.

STOP OVERPRESCRIBING WHILE IMPROVING ACCESS TO EFFECTIVE AND NEEDED PAIN MANAGEMENT

An essential part of our national strategy to address the opioid epidemic must be stopping pharmaceutical companies’ practices that lead to overprescribing. Yet at the same time, physicians still must effectively treat pain. Chronic pain is a growing public health challenge with wide-ranging impacts: keeping individuals out of the workforce, negatively affecting their mental and physical health, contributing to suicidal ideation, and otherwise limiting their quality of life. Biden believes we need to pursue two joint goals: eliminate overprescribing of prescription opioids for pain, and improve the effectiveness of and access to alternative treatment for pain. Biden will:

Support development of less addictive pain medications and alternative pain treatments, and improve standards of quality for treatment. We need pain medications that are less addictive and more effective. Biden will invest in NIH research to develop these new medications. By doubling funding for NIH’s HEAL program, Biden will accelerate research regarding alternative treatments and therapies and help providers and patients better understand the options and access alternatives. And, he will direct the FDA to give priority to new pain medications with a documented reduced risk of addiction.  

Expand coverage for alternative pain treatments. As documented in a recent study related to back pain, some non-pharmacological pain interventions (e.g., psychological counseling, acupuncture, physical therapy, or occupational therapy) are not consistently covered or have administrative barriers to coverage (e.g., pre-authorization, visit limits). In accordance with evidence-based medicine, Biden will call for a requirement that Medicare, Medicaid, his proposed new public option, and private insurance companies consistently and transparently cover alternatives to opioids for chronic pain, without barriers such as prior authorization or high levels of cost-sharing. 

Crack down on misleading advertising regarding substance use disorder treatment facilities with no basis in evidence. Biden will ensure that the Federal Trade Commission and the FDA act when companies try to mislead. He will appoint leaders of both agencies who will make this a key priority. 

Provide training to medical personnel in pain management and substance use disorder treatment. Building on the Obama-Biden Administration’s prior efforts, Biden will direct the U.S. Department of Health and Human Services to work with the medical community to support research and the development of curricula and training regarding pain management. He will ensure that the systematic study of pain management and substance use disorder is a mandatory part of the curricula and material on which doctors and other medical personnel are tested. Those seeking a federal DEA license to prescribe controlled substances will be required to receive training on proper prescribing guidelines and pain management.

Expand the effectiveness of monitoring programs designed to prevent inappropriate overprescribing of opioids. Prescription Drug Monitoring Programs (PDMPs) are electronic databases designed to prevent drug abuse. For example, a provider can check the database before prescribing in order to determine whether his or her patient has been getting the same prescription from multiple providers. In order to receive any of the $125 billion in new grants under the Biden Administration, states will have to institute a requirement that every prescriber checks the database every time they write a new opioid prescription. Biden will also set aside some of these grant dollars to ensure states improve Prescription Drug Monitoring Programs data-sharing across state lines.

Ensure regular updating of the Centers for Disease the Control and Prevention (CDC) prescriber guideline based on the best available evidence. The CDC has issued a guideline to help prescribers make evidence-based decisions regarding when and how to prescribe opioids in order to minimize the risk of abuse while also effectively treating pain. Biden will ask the CDC to commit to regularly updating these guidelines as new evidence emerges regarding opioid abuse risk factors and alternative pain treatments. And, he will partner with health care providers and states to maximize providers’ awareness and use of the guideline.

REFORM THE CRIMINAL JUSTICE SYSTEM SO THAT NO ONE IS INCARCERATED FOR DRUG USE ALONE

Biden has released a criminal justice plan that will strengthen America’s commitment to justice and reform our criminal justice system by building a system focused on redemption and rehabilitation. Biden believes that no one should be incarcerated for drug use alone, and as President he will treat drug use as a disease rather than a crime. Specifically, Biden will:

End all incarceration for drug use alone and instead divert individuals to drug courts and treatment. Biden will require federal courts to divert these individuals to drug courts so they receive appropriate treatment and services. He’ll incentivize states to put the same requirements in place. And, he’ll expand funding for federal, state, and local drug courts and other programs that divert individuals who commit crimes as a result of or in furtherance of substance use disorders to treatment rather than incarceration.  

Get people who should be supported with social services – instead of in our prisons  – connected to the help they need. Too often, those in need of mental health care or treatment for a substance use disorder do not get the care that they need. Instead, they end up having interactions with law enforcement that lead to incarceration. To change the nature of these interactions, the Biden Administration will fund initiatives to partner mental health and substance use disorder experts, social workers, and disability advocates with police departments. These service providers will respond to calls with police officers so individuals who should not be in the criminal justice system are diverted to treatment for substance use disorder or mental illness, when appropriate, or are provided with the housing or other social services they may need.

Read more about Biden’s plan to reform the criminal justice system at https://joebiden.com/justice/.

STEM THE FLOW OF ILLICIT DRUGS LIKE FENTANYL, ESPECIALLY FROM CHINA AND MEXICO

As part of a comprehensive agenda that prioritizes prevention, treatment, recovery, and harm reduction, Biden believes that part of the solution to the opioid crisis involves preventing bad actors from smuggling opioids and other illicit drugs into our country. Specifically, Biden will:

Make fentanyl a top priority in our dealings with China. The Treasury Department has already sanctioned a small number of Chinese nationals in connection with fentanyl – it’s a good start, but going after individuals will not alter Beijing’s thinking long-term. Biden will pressure Beijing to crack down on illicit fentanyl production in China and stem the flow of the drug into the United States. Biden will also develop regional strategies in the Asia-Pacific and the Americas to deal with shifts in the routes and sources of fentanyl in response to a Chinese crackdown.

Enhance cooperation with Mexican authorities to disrupt the movement of heroin and fentanyl across the U.S.-Mexico border.  Chinese fentanyl is frequently transshipped through Mexico, and then smuggled across the border in pure form or combined with heroin. As China takes steps to police fentanyl and its precursors, production and distribution will increasingly shift to Mexico. Biden will pursue strong, sustained cooperation with Mexican authorities to disrupt suppliers and supply routes, including the importation of precursor chemicals from China. The Biden Administration will also provide technical assistance to enhance the Mexican Post Service’s (SEPOMEX) ability to detect and electronically track shipments of fentanyl and precursors that come through Mexico. As President, Biden will repair the damage to U.S.-Mexico ties inflicted by Donald Trump and develop a common agenda with Mexico that looks beyond our shared border to promote our shared prosperity and protect U.S. national security interests. 

Enforce sanctions on international actors engaged in the trafficking of illicit drugs like heroin and fentanyl. Biden’s Treasury Department sanctions team will map the financial institutions and networks that facilitate the distribution of fentanyl and key precursors and develop sanctions packages based on that evidence and task the Office of the Director of National Intelligence to support these efforts with a focus on illicit finance.

Increase cooperation among global law enforcement agencies. Biden will direct U.S. law enforcement agencies to work closely with foreign counterparts, share threat information, and use technology to assist in tracking and seizing illicit shipments.

Ensure federal agencies have the tools and resources they need to stop the flow of fentanyl from abroad. Fentanyl producers have exploited gaps in monitoring through the U.S. Postal Service (USPS) to flood the U.S. with the deadly product. Biden will give the USPS the tools and resources it needs to carry out that mandate and disrupt the large supplies of fentanyl that are sent through the mail system, working with U.S. Customs and Border Protection. In addition, the vast majority of opioids and fentanyl are shipped through legal ports of entry—not in between them. Rather than waste resources building a wall or tearing families apart, Biden will direct resources to the ports of entry to interdict opioid shipments there.

Combating the Opioid Epidemic and Substance Use Disorders, Paid for By Making Sure Pharma Pays Its Fair Share

Biden’s $125 billion investment in a comprehensive response to the opioid epidemic and substance use disorders is paid for by raising taxes on the profits of pharmaceutical corporations.

Filed under: General Problems | 1 Comment »

They are dropping like flies… but no one is really keeping stats

Posted on February 27, 2023 by Pharmaciststeve

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.

Filed under: General Problems | 11 Comments »

From Eugenics to Genocide

Posted on February 26, 2023 by Pharmaciststeve

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

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.

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 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.

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. 

“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.

Kassy Dillon is a reporter for Digital Originals. You can reach her at kassy.dillon@fox.com and follow her on Twitter at @kassydillon.

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Reportedly Kaiser has discharged all chronic pain pts unless cancer or palliative care

Posted on February 25, 2023 by Pharmaciststeve

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

 

 

 

 

https://preview.redd.it/wr11sf8eq5ka1.jpg?width=3072&format=pjpg&auto=webp&v=enabled&s=95e093f4b922fcf8bfcdd3951aa6796ef4c0f10c

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Canadian panel pushes assisted suicide for minors without parental consent

Posted on February 24, 2023 by Pharmaciststeve

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."

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.

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.

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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Walmart lawsuit against U.S. over opioids is dismissed

Posted on February 21, 2023 by Pharmaciststeve

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.

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EQUALITY – EQUITY – INCLUSION

Posted on February 20, 2023 by Pharmaciststeve

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

Posted on February 19, 2023 by Pharmaciststeve

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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Medicare announces plan to recoup billions from drug companies

Posted on February 18, 2023 by Pharmaciststeve

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.

This story was produced by Tradeoffs, a podcast exploring health care 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.”

Legal fights and loopholes could blunt Medicare's new power to control drug prices

Legal fights and loopholes could blunt Medicare’s new power to control drug prices

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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Just because someone has a Medicaid health insurance card does not mean they have access to health care

Posted on February 18, 2023 by Pharmaciststeve

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

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

More than a decade after the Affordable Care Act, commonly known as Obamacare, became law, most states — red and blue alike — have concluded that the law’s offer of federal money to cover Medicaid expansion is just too good to pass up.

Medicaid is the joint federal-state program that provides health insurance for low-income individuals and children.

Originally designed as a safety-net program, it has ballooned to cover well over a quarter of the United States population. A central part of the Affordable Care Act was a provision allowing states to expand Medicaid coverage to working-age, able-bodied adults, with the federal government covering at least 90% of the cost.

 

Originally, state decisions about whether to expand fell along the traditional red-blue divide, but as the years have gone by, more GOP-led states have embraced expansion.

Today, only 11 states have refused to expand their Medicaid program. Apparently, even red states found the money irresistible — what’s not to love about spending $1 and receiving $9?

As it turns out, there’s a lot not to love about expanding Medicaid, starting with how it hurts those who most need help.

Americans for Prosperity’s Senior Health Policy Fellow Dean Clancy sums up the problems facing Medicaid:

Medicaid is a broken program, overly bureaucratic with weak cost controls and no accountability for results. It provides notoriously substandard care for patients and yet also manages to waste one of every five dollars it spends. Medicaid should be fixed, not expanded.

Medicaid fails those who need it most

The argument for expanding Medicaid is straightforward: Low-income Americans lack access to health insurance and, as a result, lack access to care. Medicaid solves this problem by providing them essentially free health insurance.

This argument runs aground, however, on the rocky shoals of Medicaid’s realities. Just because someone has a Medicaid health insurance card does not mean they have access to health care.

Everybody knows that health care in the United States is expensive, and so full access to care depends on having health insurance. But Medicaid does not come close to providing the kind of coverage that private insurance does.

Medicaid’s payment rates to health care providers are so low — one figure puts them at a quarter of private insurance rates — that many doctors won’t take on Medicaid patients.

  • A 2014 government study found that only half of doctors who claim to take Medicaid patients are actually accepting new ones.
  • A 2019 study found that Medicaid patients are 1.6 times less likely to successfully schedule a primary care appointment, and 3.3 times less likely to see a specialist.
  • Wait times for Medicaid patients are also substantially higher.

As a result, those with Medicaid are too often left out in the cold, so they turn to the one place they know they can get treatment whenever they want: the emergency room, the most expensive kind of care.

A 2021 study found that “Emergency department wait times increased 10% under Medicaid expansion.”

Medicaid fails those who need it in another way, too.

Medicaid too often fails to improve the health of those who have it

Oregon ran an experiment on its Medicaid program, randomly selecting some people to enroll and tracking their health versus those who could not enroll — the gold-standard in experimental design.

The results were startling.

According to the National Bureau of Economic Research, enrollment in Medicaid “produced no statistically significant effects on physical health.”

More specifically, while enrollment reduced depression, it had “no statistically significant effects on blood pressure, cholesterol, or cardiovascular risk.”

These results show that those with Medicaid are no better off than those with no insurance at all

Oregon is just one state, but Medicaid care elsewhere has proven disastrously bad, too.

A group of patients in California, for example, has sued that state’s Medicaid program for sub-standard care — despite the fact that California’s private Medicaid insurers are raking in billions of dollars in profits.

But Medicaid’s problems extend even further.

Expanding Medicaid has unintended consequences that hurt the most vulnerable

Medicaid expansion promises states health insurance expansion on the cheap, but not without a cost on those who need help the most.

A landmark report from the Mercatus Center examined whether Medicaid expansion altered states’ Medicaid spending. It found that expansion states spent significantly less on vulnerable populations than non-expansion states.

The study’s authors write:

Per capita Medicaid spending growth on children in expansion states was less than one-third what it was in non-expansion states and less than one-quarter of national average per-capita healthcare spending growth.

Children in expansion states received $500 less in state funding over the first six years of expansion than those in non-expansion states. The study also found cuts for the disabled and elderly.

Another study from Harvard found a similar dynamic at work in education. A $1 increase in social-services spending — driven by Medicaid — resulted in $2.44 less being available for higher education.

These results aren’t surprising: Unlike the federal government, states can’t put higher costs on a limitless credit card. Budget management demands that resources spent on one priority must be inevitably pulled from others.

Yet states have more to fear than redirected resources.

Medicaid expansion threatens the fiscal stability of states, both short-term and long-term

Short term, states that expand Medicaid are likely to see substantially higher costs than they expect

At an alarming rate, states that have expanded Medicaid have seen actual enrollment vastly outstrip projections, meaning Medicaid punches a bigger hole in state budgets than lawmakers expected.

Medicaid spending comprises, on average, 27% of state budgets, making it the largest spending category. So even if the federal government picks up 90% of the tab for all the new enrollees, the 10% state portion is still a very large sum of money and can bust state budgets.

  • According to one study, enrollment of the newly eligible population is 160% above projections — 16.7 million people instead of 6.5 million.
  • Per-person costs are also 64% above estimates.
  • And expanding Medicaid has led to more people enrolling in Medicaid who already qualified for the program pre-expansion. This “woodwork effect” leads to about a 10% rise in traditional Medicaid rolls on top of expansion.

Long term, there is little that states can do to cap their costs, which makes Medicaid a massive liability to their fiscal stability

The federal government restricts how states can modify their Medicaid programs. They can’t limit enrollment and haven’t been allowed to remove ineligible individuals for the past three years thanks to a federal provision that Congress wisely voted to sunset beginning in  April.

As a result, if Medicaid becomes fiscally unsustainable, states have essentially no choice but to quit the program or the expansion altogether — a politically unpalatable move at best.

What’s more, there is nothing to prevent Congress from lowering the federal reimbursement rate for the expansion population, which could leave states on the hook for billions more.

These high costs might be worth it if the money were well-spent, but it isn’t.

  • Federal data uncovered by Americans for Prosperity Foundation show that more than 1 in 5 dollars spent on Medicaid in 2020 were spent improperly, with $86 billion spent wastefully.
  • The expansion seems to be fueling improper payments.
  • The improper-payment rate has more than tripled, from under 6% before Medicaid expansion to more than 20% now.

With all these problems, lawmakers would do well to look beyond the dangling federal dollars of Medicaid expansion.

Lawmakers can follow a better path: a Personal Option

Medicaid expansion might seem like the only game in town, but the reality is state lawmakers have a number of different options for expanding access and reducing costs, many of which are part of the Personal Option.

“States don’t have to wait for Washington,” AFP’s Clancy says. “They can do a number of things right now to help promote access and lower costs while shielding individuals from risk.”

  • Repeal Certificate of Need laws that make it difficult to open new doctors’ offices and hospitals.
  • Increase the supply of doctors and nurses by allowing them to practice across state lines.
  • Expand the scope of work for nurses and physician’s assistants so they can do all they are trained to do.
  • Allow pharmacists to administer shots and prescribe low-risk medications.
  • Loosen telehealth regulations to give patients access to medical experts across the state.
  • Enable access to farm bureau (or other nonprofit membership organization) health insurance plans, which can be much cheaper than normal insurance.
  • Promote charitable care as an option for uninsured or underinsured people who struggle to afford quality health care.
  • Promote direct primary care as a viable option for Medicaid patients, freeing them from the burden of using insurance as a middleman.

 

These reforms would increase the number of options and reduce costs — changes that, while helping everyone, would have an outsized impact on low-income individuals. And a number already have a track record of success.

In Dallas, for example, Carrell Clinic Foundation is demonstrating the effectiveness of the charitable care model, offering high quality care at little to no cost.

But state lawmakers can push further.

One innovative option is to allow Medicaid beneficiaries to enroll in a direct primary care arrangement using Medicaid funding.

Such a reform would ensure Medicaid patients have access to doctors while cutting out insurance and giving beneficiaries more control over their health care long-term, building on the success of direct primary care providers such as Camino Health Center in North Carolina.

This reform might require, however, a federal waiver.

For its part, the federal government could do a variety of things to help reduce costs and improve access, from getting rid of the rules that limit who can have a health savings account to promoting price transparency to streamlining drug approval — all part of the Personal Option.

States must resist the siren song of federal funds if they truly want to help people

At the end of the day, Medicaid is a federal program, and any major reform will require cooperation from Washington.

To help low-income people the most, state lawmakers will need to do more than resist the siren song of federal funds in Medicaid expansion.

They will need to enlist the federal government’s help in pursuing sensible reforms that promote access while reducing costs.

“Instead of putting more people on the Medicaid rolls,” says Clancy, “states need a lot more flexibility from Uncle Sam to eliminate waste and target scarce resources to the truly needy.”

Medicaid was meant to be a safety net for the truly vulnerable. Misguided expansions have turned it into a sprawling, wasteful entitlement that fails to ensure timely access to needed care.

We can do better. Instead of expanding Medicaid, we should reform it to be worthy of the vulnerable families who need it most.

 

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