Bombshell Revelation from Government

Bombshell Revelation from Government

https://doctorsofcourage.org/bombshell-revelation-from-government/

picture of HHS response to FOIA request


Government Documents Expose Unconstitutional Arrests of Physicians in Massive Operations

In a shocking turn of events, the U.S. Government, in response to Freedom of Information Act (FOIA) litigation in the case of Neil Anand et al. v. U.S. Department of Health and Human Services (Civil Action No. 21-1635), revealed a startling truth that will have far-reaching consequences for physicians across the United States. The government’s admission, concealed for years, unraveled a series of mass arrests in operations that have been likened to infamous historical events.

Numerous physicians across the United States were arrested in a single day during massive, seemingly unconstitutional operations. These operations, bearing ominous names like Operation Pill Nation, Operation Snake Oil, Operation Oxy Alley, Operation Juice Doctor, and Operation Wasted Daze, have drawn comparisons to the infamous Nazi operation, Kristallnacht, or the Night of Broken Glass, which targeted Jewish physicians.

The bombshell revelation came through Robin Brooks, Director of Freedom of Information, who disclosed a shocking amount of previously confidential information in her letter to Dr. Neil Anand. Brooks unveiled that the government had concealed crucial information related to the Pill Mill Doctor Project, a United States “Manhattan Project” colossal effort in solving the U.S. Opioid Crisis. The disclosure included eight-hundred-thirty-five pages of records responsive to Anand’s FOIA request, of which only sixty-one pages were released in their entirety. The rest of the documents contained numerous redactions, withholding essential information under various exemptions like Exemption 3, Exemption 4, Exemption 6, Exemption 7C, and Exemption 7E of the FOIA.

However, the most significant revelation from these government documents is the exoneration of physicians involved in opioid prescribing. The U.S. Surgeon General’s admissions, contained in the official government documents produced pursuant to the FOIA, unequivocally prove that opioid prescribing physicians did not engage in criminal activity in violation of the Controlled Substance Act. These admissions confirm that the defendants and other similarly situated physicians could not have formulated the necessary intent to participate in a criminal act under the Controlled Substance Act.

The government documents reveal the historical context that may have contributed to increased opioid prescribing in the United States. Physicians, driven by good intentions and erroneous Government training and teaching, prescribed opioids to manage pain, believing they were safe and effective. Surgeon General Vivek Murthy’s admissions in the documents underscored the dire consequences of Government misinformation and misguided practices. The Government’s role in promoting the use of opioids as a pain management solution and the Fifth Vital Sign has been unveiled, emphasizing the importance of considering the circumstances that led to the increase in opioid prescribing.

The legal implications of this revelation are profound. The United States Supreme Court’s precedent in cases such as Raley v. State of Ohio, Lanzetta v. State of New Jersey, and United States v. Cardiff reaffirms that the government cannot sanction the most indefensible form of entrapment by actively misleading its citizens. The government’s failure to provide clear guidance to physicians and, in some cases, actively promoting the use of opioids has now come under scrutiny. These Supreme Court precedents suggest that citizens may not be punished for actions undertaken in good faith reliance upon authoritative assurances that punishment will not attach, especially when they operate under vague, undefined, or contradictory commands.

In conclusion, the shocking revelation of government documents through FOIA litigation in the case of Neil Anand et al. v. U.S. Department of Health and Human Services has brought to light the government’s role in opioid prescribing and raises serious questions about the legality of the arrests of physicians. The government’s conduct, which amounts to “active misleading,” may have far-reaching legal consequences for those arrested in the massive healthcare operations. The fallout from these revelations is likely to shape the future of healthcare practices and law in the United States, and could potentially lead to the exoneration of physicians who were unjustly targeted in these operations.

 

Don’t they know who they work for?

I saw someone make this statement on the web. Don’t they know who they work for? The “they” ,that they are talking  about is POLITICIANS. Particularly those in Congress.  https://www.bbc.com/news/av/election-us-2020-54696386  According to this article in 2020 Federal Presidential and Congressional candidates spend 14 BILLION – TWICE AS MUCH as was spent on the 2016 election.

That doesn’t include the 4.1 billion that was spent on lobbyist in 2022. That is 11+ million/day, to help influence the 535 members of Congress. That averages out to abt $11,000/day – 7 days a week on each member of Congress.  https://www.opensecrets.org/news/2023/01/federal-lobbying-spending-reaches-4-1-billion-in-2022-the-highest-since-2010/

With all those $$ flowing into election campaigns, and $$ to influence members of Congress by Lobbyists, who believes that any letters, emails, phone calls to member of Congress will influence their decisions in any way?

Congress basically functions on a seniority system.  Both the House & Senate have numerous committees. Each committee has a chairman, who will belong to the political party of the majority of the particular party and a co-chair that belongs to the political party that is the majority. The balance of each committee will reflect the percentage of the political party in the majority.

For anything to potentially become a law, it starts with a bill being introduced by one of the members of a the appropriate  committee. The chairman may nor may not bring up a bill for a vote. If the chairman does not bring a bill up for a vote. It becomes DOA.  I saw it reported that Alexandria Ocasio-Cortez  (AOC) introduced 20 bills during her first 2-yr term in the House, and none was brought up by chairman of the committee for a vote.

If a bill get voted out of committee, the bill goes to the Speaker of the House or Head of  the Senate. Each can chose to bring the bill to the floor for a vote or not. If one or both of those refuses to bring the bill to the floor for a vote, the bill DIES!

If the bill is passed by the House and the Senate, it is then sent to the President to sign it into law.

The President can sign the bill into law or veto it. If the President VETOES the bill, then the Senate and House has the option to override the President’s veto with a 2/3 vote by each. If the Senate or the House fails to vote to override the bill, the bill becomes law.

 

 

Looking back.. revisiting a post that I first started in Nov 16, 2014

 

 

 

 

 

 

 

This post originally appeared on my blog Nov 16,2014 and last updated Feb 4,2016. https://www.pharmaciststeve.com/genocide-in-america/ This is before the CDC 2016 opioid dosing guidelines were published and about 2-3 yrs after the opioid Rxs dispensed had peaked.  Some states have passed law in recent years, that is suppose to protect practitioners and pts when prescribing opioids to pts. But few seem to admit that they have done little/nothing to help all involved. Is all the deaths from under/untreated pain or is all the suicides just “swept under the rug” and all the relatives leave the funeral home, saying ” .. at least he/she is “at peace…”


This page is going to contain posts made on other places on the web by those in chronic pain and how the war on drugs has turned into a war on pts. The number of people who are abusing some substance is not going down, but the number of chronic pain pts not being able to get their chronic pain adequately treated is rapidly increasing… as is the use/abuse of Heroin.

History shows us other countries that have had a OVERT genocide… It would appear that our society has chosen to have a COVERT genocide. The rules/guidelines in place is like playing cards with a stacked deck  Just label it as a accident ?

And the whole process’ genesis was based on racism and bigotry War on Drugs GENESIS… BIGOTRY ?

As more and more chronic painers lose or have their therapy cut or they are more and more home bound and more and more INVISIBLE to our society.. They are emotionally, physically, mentally exhausted… many are losing or have lost the will and ability to “FIGHT” and having to deal with increased depression.

I am not encouraging or endorsing suicide.. I am trying to make those with chronic pain MORE VISIBLE to those in our society that are CLUELESS !


For 16 yrs I used pain meds with very little problems. I took higher doses then most. Some people think if u weight 100 lbs u shouldn’t need the same dose as a 200 lb man. I sometimes vacation from one med to another for a month or two then go back . This helped to keep doses from getting higher and higher. Worked for me. I took my meds every 4 hours. i lived a pretty good life. Could work clean house and care for the kids. Do my community service. Felt pretty good about myself. Then last yr around this time it all went down hill. Only allowed to use meds every 6 hrs and at half the dose. Then no one would fill my scripts because my drs office was 40 miles from my home. For one yr I got my meds by mail or fed ex. That really sucked waiting and waiting for my meds to come. Then Aug 21 2014 I got that letter from my dr. Dropping me as a patient after 16 yrs. now I have nothing. I suffer everyday every hour every min. I can’t sleep I can’t function. I wake up everyday wishing I hadnt. Why didn’t I just die? I never thought this would happen to me never never but it did. I almost did kill myself two weeks ago but I don’t want to do that to my son. The pain it would cause him. What is my future don’t know? I did get lucky a couple days ago and found an old pain patch from 2008. Worked great. Don’t want to hear anything about it being expired nor do I suggest this to anyone else. What did I have to lose? I got to be a person again for a few days.got some stuff done. Made me feel better about myself. I smiled and got some sleep. I know that my life has to have some kind of pain management or I will kill myself. I would like to have my old meds back but those days r gone now. Medical marijuana is now my only hope because the pill problem keeps getting worse. I need that hope. I don’t want to die but I can’t live with this nerve pain. At the city hall meeting for mmj those people against talked about pain meds and pot as one and the people that used them r just the scum of the earth.the looks I got. I am sick not an addict or a bad person. I am a good caring person and didnt deserve the looks I got. I hope this doesn’t happen to anyone else in this group. But I don’t see things getting better only worse in this state of FL. This group keeps growing more groups r popping up. Sorry to say but we r at war. I know how the Jews felt when Hitler came to town. People,here in FL Pam Bondi is way ahead in polls. Why she is a monster. I have new found hope from younger people voting and or getting involved in their government. But this too might take some time. Got to vote. Talked to over 50 kids yesterday at the mall about voting this coming election.they can make things better for us so u better treat these kids with respect. They r our future


WELL SHIT!!!! I JUST GOT OUT OF ICU FOR TRYING TO KILL MYSELF BECAUSE IM SO TIRED OF HAVING UNMANAGED PAIN TO BEGIN WITH HERE IN LOVELY FLORIDA……GOOD THING I HAVE A BACK UP PLAN CAUSE IM NOT DRINKING CHARCOAL AGAIN!


http://www.news-press.com/story/news/crime/2014/09/08/death-investigation-at-groves-rv-park-in-fort-myers/15280035/

A husband and wife were found dead at their trailer Monday at the Groves RV Resort on John Morris Road, apparently the victims of a murder-suicide.

The Lee County Sheriff’s Office responded to unit #100 in the resort at 16175 John Morris Road at 8:30 a.m. Monday.

The sheriff’s office report said the response was in reference to a male caller advising the LCSO that he and his wife “could no longer stand the pain and that they were leaving.”


 We SHOULD BE spending our time trying to take care of our pain !!!  I don’t think heroin addict’s spend that much time running around looking for it on the streets !!!
I ALMOST HAD TO go that route … Because of WAY Too much pain …  With absolutely no pain relieving medication  Better off …going to the streets eh ???
No judgements or rationing on the streets !!!  No wonder we turn to the streets for our necessary/life saving medication !!! Is that their agenda ???
Or just wait till we kill our selves because the pain is too bad ???  Kinda like genocide by suicide ?!?! It’s just unacceptable !!!


Just can’t do this anymore


I am done. Fed up of pain. Fed up of drs and people screwing my life up. Making me live in agony for no reason when they have the power to help. I only ever go to hospital when there is no other choice, when I am in a full blown life threatening crisis. I only ever cry out for support when I am at the end of my rope. But now that rope has snapped. Can’t keep asking for help and support and being rejected by everyone again and again. It is in humane to be in this much pain, it is cruel. I don’t know how much everyone expects me to deal with all the time but I am DONE. I am not living like this anymore.


I’m about done with living. This isn’t living and I hate the quality of so called life I have. This whole thing has thrown me into a fibro flare on top of my back pain. I hurt so bad now I want to die.


 This is a debate question. Not a plan of action !!!!   When is it okay to give up?  When is it okay to want to stop this constant pain?  My wife says it’s selfish for anyone to contemplate taking their life but I think it’s selfish to make someone live like this Every day …..day after day after day.  Today is not a horrible day. Today is an okay day. This is a debate question. Not a plan of action !!!!


 Maybe I shouldn’t ask this, but I’m absolutely at my end. Feel free to message me if you don’t feel comfortable here. I need pain meds, BADLY. I can’t go on much longer this way. I contemplate suicide daily. I’m not a good mother. Or wife. Or friend (which I’ve lost most because the pain makes it unbearable to go out and be social). I can’t work much anymore, which is putting a huge financial and mental/emotional strain on my poor husband. I can barely keep up with my housework either. I feel like a 30 year old failure. My doctor took me off of the one thing that helped me, tramadol. Since then I’ve rapidly gone down hill.


 I bet no one would care if I died, so why not get it over and done with, I mean no one wants to help me. So why bother with life. I’m in agonizing pain daily. Im a looser now and always will be and I drive people away so dont bother being my friend because ill probably make u hate me like I do with everyone else.


 My wife has really been struggling in the last few months. This month has especially been difficult. She has stated many times that her fibro is getting worse. She has ran out of her pain meds and became very depressed. Yesterday she tried to kill herself. I found her face down on her bedroom floor. She had overdosed on other medications and was barely conscience. Ambulance took her to er, after 5 hours a private room. She finally became alert at 11pm enough to answer questions. She was transferred to an ICU last night and today at 5pm transferred to another hospital to deal with the depression.


 I know it is heartbreaking to miss these things and see the disappointment on their faces and people and family want to judge me because I have decided to end my pain on my dad’s bday and are making preparations to do so then I do not have to face begging doctors for enough ends that don’t even touch my pain and be treated like a criminal because I have multiple health issues. I give up


 http://www.infowars.com/i-am-sorry-that-it-has-come-to-this-a-soldiers-last-words/

This is what brought me to my actual final mission. Not suicide, but a mercy killing. I know how to kill, and I know how to do it so that there is no pain whatsoever. It was quick, and I did not suffer. And above all, now I am free. I feel no more pain. I have no more nightmares or flashbacks or hallucinations. I am no longer constantly depressed or afraid or worried

I am free. I ask that you be happy for me for that. It is perhaps the best break I could have hoped for. Please accept this and be glad for me.


 I have a family member who has been in excruciating pain for years, surgeries and injections made it worse. The only thing that gave him the slightest relief was methadone. Well, insurance changed their rules and would not pay anymore, so they have been paying out of pocket. Sunday night he snapped, couldn’t take it anymore and took his life. Why am I telling you? His family is falling apart.


 Hey everyone, I am xxxxxx, 33 years old RSD both legs from thigh to toes, spreading to my hands and calves. I am the most depressed I have ever been, I lost my job, Im a nurse, nothing bad, they were just ridding themselves of Per Diem nurses so I took that hit. I am a single mother of two beautiful girls, 4 years old and 19 months old. My car is about to die, my pain is incredible and nothing seems to work,my hair is falling out root to tip in clumps, I cant stop crying, all I need is a hug. It is so hard to wake up every day and be in this horrific pain. Im out of options, I don’t have any fight left in me,im done with this.


 i am seriously considering participating in Doctor assisted end of life ..reason i can’t take this pain anymore.. It’s not fair for my wife to see suffer on a daily basis.. we don’t have children.. I understand such bill is directed to terminally ill..I will find a mental health provider who will support my decision.. No body cares!.. I reach out to the medical community they use me for $$$ i am referring to surgeons and the legal community could care less.. I guess my ethnicity as a latino in spite of my american heritage is not worth the effort.. It’s not just the arch problem i have a torn theal sac and my orthopaedic surgeon has abandoned me completey.. Sure my wife’s insurance has made him rich along with my medicare due to Permanent disablity.. let’s face it.. the medical and legal community would see me as a total loser..If i hit the lottery or had resources life would be totally different in spite of my pain..I am sick and tired of the bullshit and pain that i endure each and every day…


 Last night a 19 year old friend from Key West died. Pain medication overdose how sad.


 http://www.rawstory.com/rs/2014/11/mich-medical-marijuana-card-holder-commits-suicide-after-police-witch-hunt-over-pot-butter/


 This weekend has been awful. I lost 2 good friends. One died of a heart attack and the other committed suicide pain level is out of the roof


 I just want to die, then I will be in peace no more pain!


Have anyone of you got to the end of the rope and want to let go. No more pain, i wouldn’t in my wildest dreams wish the amount of pain im in on my worse enemy. There is days i pray for god to end it. in sick and tired of being sick and tired. all the meds im on even meds for depression are not helping.i cant sleep, sit, stand, walk w/o being in major pain. i need help i cry myself to sleep the nights i do sleep. im at my max by the DEA law idk what else to do


 Sxxxxx  hung herself Christmas morning. She could no longer take the pain. She tried for a year and a half. She lost her job and had to move in with her son. She spent her last months home bound. She was very scared and alone. The pain was bad enough where she needed help getting into the bath…
Everyone please think of her today. This could be any one of us….
How much can you take? It’s not like she could put the pain away in a drawer for a while. She couldn’t just take a vacation from it. It caused her daily severe panic and fear of leaving the house…Or thinking of the future. She left no note …  12/28/2014


My late wife Karen lost her battle to Chronic Pain via suicide. I’d like to find out more about the (Cake) movie?


At around 330 am my cell phone rang and when your phone rings at that time it’s not going to be good, a very good and close personal friend of mine had been found unresponsive in her bathroom by her hubby, one of my best friends and how I met her actually, he thought maybe she had a heart attack and called 911. They get there and get her to the hospital had to shock her 5 times before they called it. Not knowing the reason they had to run to screens and do an autopsy. She was a chronic pain patient who her new PCP told her she was to young to be experiencing that kind of pain and sent her to a Psychiatrist early this week who was very nice and respectful to her and gave her phych meds and a sleeping pill. Her new Dr being a yutz that she is cut her off of her pain meds accept topomax and a muscle relaxer, this down from oxycodone and other meds. She committed suicide early this morning. Her daughter found the note along with all her personal papers including a living will that was DNR, hospital ER staff is not to blame nor the EMT’S because it has not been notorized as of yet. But this Doctor, boy this Doctor she is going to be meeting my lawyer friend I went to High School and some College with and if he can win a case before the supreme court he can kick this Doctors ass. I will also be calling the Bishop Cupich and a very old friend Cardinal Timothy Dolan who started out as a Priest and the Bishop in Milwaukee to get her a dispensation to be buried in consecrated ground and to be able to have her mass and funeral at her Church. So after typing all of this it was to say we have lost another one unable to bear the pain anymore. No she wasn’t in this group she is from Chicago area.


 

CRUCIFEID ON THE BLUE: DOSE #3 COURT UPHOLDS SETTLEMENT ON BLUE CROSS DISCRIMINATION PRACTICES

COURT UPHOLDS SETTLEMENT BLUE CROSS

CRUCIFIED ON THE BLUE CROSS: JEWISH, BLACK, BROWN, AND WOMEN PRACTITIONERS CONFIRMED DISCRIMINATION UNITED STATES DEPARTMENT OF JUSTICE vs. NEIL ANAND ( THE 3rd. DOSE)

DEA: RE-INCARNATION OF THE 3RD REICH, PROSECUTIONS SPARKS PUBLIC CONCERN

HOWARD ADELGLASS, MD
NOW SERVING FEDERAL 12 YEARS PRISON Practicing Medicine while JEWISH PRE-COG

 

ALLEGATIONS OF 3RD REICH NAZI IDEOLOGIES IN U.S. HEALTHCARE PROSECUTIONS SPARK PUBLIC CONCERN AS TO THE FINAL SOLUTION IN MEDICAL PAIN CARE TREATMENT ( THE ADELGLASS PAPERS, “1st DOSE” )

 

WHO releases guidelines on chronic low back pain

WHO releases guidelines on chronic low back pain

https://www.who.int/news/item/07-12-2023-who-releases-guidelines-on-chronic-low-back-pain

The World Health Organization (WHO) is releasing its first-ever guidelines on managing chronic low back pain (LBP) in primary and community care settings, listing interventions for health workers to use and also to not use during routine care.

Low back pain is the leading cause of disability globally. In 2020, approximately 1 in 13 people, equating to 619 million people, experienced LBP, a 60% increase from 1990. Cases of LBP are expected to rise to an estimated 843 million by 2050, with the greatest growth anticipated in Africa and Asia, where populations are getting larger and people are living longer.

The personal and community impacts and costs associated with LBP are particularly high for people who experience persisting symptoms. Chronic primary LBP referring to pain that lasts for more than 3 months that is not due to an underlying disease or other condition – accounts for the vast majority of chronic LBP presentation in primary care, commonly estimated to represent at least 90% of cases. For these reasons, WHO is issuing guidelines on chronic primary LBP.

“To achieve universal health coverage, the issue of low back pain cannot be ignored, as it is the leading cause of disability globally,” said Dr Bruce Aylward, WHO Assistant Director-General, Universal Health Coverage, Life Course. “Countries can address this ubiquitous but often-overlooked challenge by incorporating key, achievable interventions, as they strengthen their approaches to primary health care.”

With the guidelines, WHO recommends non-surgical interventions to help people experiencing chronic primary LBP. These interventions include:

  • education programs that support knowledge and self-care strategies;
  • exercise programs;
  • some physical therapies, such as spinal manipulative therapy and massage;
  • psychological therapies, such as cognitive behavioural therapy; and
  • medicines, such as non-steroidal anti-inflammatory medicines.

The guidelines outline key principles of care for adults with chronic primary LBP, recommending that it should be holistic, person-centred, equitable, non-stigmatizing, non-discriminatory, integrated and coordinated. Care should be tailored to address the mix of factors (physical, psychological, and social) that may influence their chronic primary LBP experience. A suite of interventions may be needed to holistically address a person’s chronic primary LBP, instead of single interventions used in isolation.

The guidelines also outline 14 interventions that are not recommended for most people in most contexts. These interventions should not be routinely offered, as WHO evaluation of the available evidence indicate that potential harms likely outweigh the benefits. WHO advises against interventions such as:

  • lumbar braces, belts and/or supports;
  • some physical therapies, such as traction (i.e. pulling on part of the body);
  • and some medicines, such as opioid pain killers, which can be associated with overdose and dependence.

LBP is a common condition experienced by most people at some point in their life. In 2020, LBP accounted for 8.1% of all-cause years lived with disability globally. Yet clinical management guidelines have been developed predominately in high-income countries. For people who experience persisting pain, their ability to participate in family, social, and work activities is often reduced, which can negatively affect their mental health and bring substantial costs to families, communities, and health systems.

Countries may need to strengthen and transform their health systems and services to make the recommended interventions available, accessible and acceptable through universal health coverage, while discontinuing the routine delivery of certain interventions. Successful implementation of the guidance will rely on public health messaging around the appropriate care for LBP, building workforce capacity to address chronic low back pain care, adapting care standards and strengthening primary health care, including referral systems.

“Addressing chronic low back pain requires an integrated, person-centred approach. This means considering each person’s unique situation and the factors that might influence their pain experience,” said Dr Anshu Banerjee, WHO Director for Maternal, Newborn, Child, Adolescent Health and Ageing. “We are using this guideline as a tool to support a holistic approach to chronic low back pain care and to improve the quality, safety and availability of care.”

LBP affects life quality and is associated with comorbidities and higher mortality risks. Individuals experiencing chronic LBP, especially older persons, are more likely to experience poverty, prematurely exit the workforce, and accumulate less wealth for retirement. At the same time, older people are more likely to experience adverse events from interventions, reinforcing the importance of tailoring care to the needs of each person. Addressing chronic LBP among older populations can facilitate healthy ageing, so older persons have the functional ability to maintain their own well-being.

Pharmacy Concerns are Receiving Unprecedented Media Coverage: Synergies and Momentum can be Achieved

The following article is from Dr. Daniel A. Hussar, Ph.D. who is a retired professor from the Philadelphia College of Pharmacy and produces a monthly newsletter about pharmacy issues starting back in 2006. https://pharmacistactivist.com

Dan’s and my path crossed about a decade ago when one of his former students, Joe Zorek, who was suing CVS over EEOC, ADA and Whistleblower violation. and Joe reached out to me to help him spread the word about his lawsuit via my blog.

Joe was able to get CVS to settle without going to court, but while the terms of Joe’s agreement with CVS was confidential. In talking with Joe back then, Joe was very happy with his settlement.

Pharmacy Concerns are Receiving Unprecedented Media Coverage: Synergies and Momentum can be Achieved!

https://pharmacistactivist.com/2023/November_2023.shtml

Media coverage of pharmacy-related issues during the last year has been extensive. The high cost of drugs has been a long-standing concern that continues, but much of the recent coverage has focused on medication errors, staffing and workplace conditions that cause moral injury to pharmacists and increased risk of errors for patients, anticompetitive practices of the health insurance companies with their PBMs and pharmacies, the domination of chain stores in community pharmacy and the decline in numbers of independent pharmacies, the increased number of pharmacy deserts, the fragmentation in the medication distribution system (i.e., local community pharmacy, mail-order pharmacy, specialty pharmacy), and the reduction of personal communication with and counseling of patients.

Media attention to these multiple issues is often initiated because of a harmful medication error. Although this coverage may focus on an experience in a single pharmacy that may also identify the pharmacist responsible for the error, the publicity is a blemish on the reputation of our entire profession. However, an increasing number of reporters are looking for explanations and underlying reasons for an error, and discovering there are many contributing factors such as corporate policies/metrics and understaffing. As much as we may dislike seeing a pharmacy error publicized, the more extensive coverage that reveals the error-prone circumstances under which many pharmacists work is of value to our efforts to increase awareness of and reform the pharmacy practice system. Some examples of the recent media coverage are provided in the following discussion.

USA TODAY

“Prescription for disaster: America’s broken pharmacy system in revolt over burnout and errors” is the title of the first-page story in USA TODAY on October 26. Written by senior investigative reporter Emily Le Coz, this commentary provides excellent comprehensive coverage that identifies numerous factors that contribute to the stressful pharmacy workplace challenges and the occurrence of errors. She initiated her investigation upon learning of a dispensing error that harmed a young child. At each stage of her investigation, she discovered one problem after another that result in the “broken pharmacy system” and the increased risk of errors. Excerpts of her article are provided below:

“Medication errors are a pharmacist’s worst nightmare. Many told USA TODAY they lie awake at night wondering if, in their haste, they made a mistake that might hurt or kill someone.

In May 2021, that someone was Brenden Fisher.

The Sarasota, Florida child overdosed on a newly prescribed anti-seizure medication after the CVS Pharmacy near his home dispensed the drug with the wrong instructions on the label.

By the third dose, Brenden was lethargic, dazed and struggling to breathe. His parents, Paris Bean and Jason Fisher, rushed their then 2-year-old to the hospital, thinking he was dying.

Hospital staff didn’t know what was wrong with him, Bean recalled, until a nurse asked if he was taking his 1.2 ml of levetiracetam twice daily.

When Bean told her the instructions said to give him 7.5 ml, ‘you could almost hear her jaw drop,’ Bean recalled. She said, ‘Did you give that to him?’ And I said, ‘Yes. Is that why we are here?’ She said, ‘I wouldn’t be surprised.’

Brenden still suffers from a full-body tic he first developed during the incident, his parents said, Dozens of times a day, he will suddenly stop whatever he is doing, clasp his hands together, clench his jaw and tense every muscle in his body while staring off into space. Each episode lasts anywhere from 5-10 seconds.

His parents have not been able to definitively link the tic to the overdose, but they said they have no other explanation for it.

Bean said she blames CVS for the mistake but also herself: ‘I’m the one who physically administered it…I could have killed him.’

CVS declined to comment on the error.

Bean and her husband filed a lawsuit against CVS in February that was settled out of court for an undisclosed amount. But they said they did not file a complaint with the Florida Board of Pharmacy.

That means it’s one of countless errors for which there’s no official tally or public record.”

(Editor’s note: The strategy of CVS and others against whom lawsuits are filed when there is no question that harm was caused by an error, is to quickly reach a confidential settlement in an amount that is likely just a small fraction of what might have been obtained if the lawsuit had gone to trial).

“No federal agency requires pharmacists to report medication errors, and few state boards of pharmacy mandate it. Many pharmacies and pharmacy chains track errors internally but do not share the numbers with the public. CVS and Walgreens both declined to share their data with USA TODAY.”

Numerous pharmacists told USA TODAY that errors are not consistently reported – even internally. Small mistakes and those caught early are routinely hidden.

Even when they do report potentially fatal errors, some pharmacists said, no one from their companies investigates how they occurred or makes changes to prevent them from repeating.

Pharmacists are personally liable for medication errors and risk fines, discipline and loss of license if investigated and found responsible by their state board. Many told USA TODAY they get little or no support from their company when mistakes happen, even if the conditions imposed by those companies contribute to those errors.”

“The Nevada Board of Pharmacy in September fined and suspended the licenses of two CVS pharmacists who accidentally gave a pregnant woman the abortion drug misoprostol instead of the fertility treatment she was prescribed. The mistake, which was first reported by 8NewsNow in Las Vegas, ended the woman’s pregnancy.

The Nevada board also fined CVS $10,000 over the objections of company attorney William Stilling who argued CVS itself did nothing wrong.

‘The only allegation’ against CVS, Stilling said, ‘is that they had these pharmacists.”

(Editor’s note: This shocking statement by CVS attorney Stilling demonstrates how the company’s priority is to protect its own interests while making their pharmacists vulnerable to disciplinary action. It should be widely communicated throughout our profession as a warning about the lack of support and potential consequences for pharmacists who work for certain corporate employers).

“Pharmacists take an oath to hold patient safety in the highest regard when preparing and dispensing medication. But rising pressure within the nation’s largest retail stores have forced pharmacists to choose between that oath and their job.

The situation was bad before the pandemic. COVID-19 made it worse. It has only gone downhill since then. Frustrations boiled over this autumn in a series of high-profile walkouts that left a string of CVS and Walgreens pharmacies shuttered or short-staffed. Those actions might have caught consumers off guard. But inside the troubled industry, it was the clarion call of a beleaguered workforce pushed to the brink.

Pharmacists said it’s nearly impossible to meet all the demands without cutting corners, and when corners get cut, patients can get hurt.

In California, 91% of chain pharmacists surveyed by the state Board of Pharmacy in 2021 said they lacked the staff needed to ensure adequate patient care.

Ohio proposed a series of rules this year aimed at improving pharmacy working conditions. Among them: a ban on quotas and requirements for sufficient staffing. The rules are currently pending a vote amid overwhelming support from pharmacists and opposition from retail pharmacy chains, including Walgreens and CVS. ‘The Board should stay focused on the regulation of the practice of pharmacy rather than the business of pharmacy’ wrote CVS Director of Regulatory Affairs John Long in opposing an early version of Ohio’s rules last year.”

“Retail pharmacy wasn’t always this bleak.

A constellation of factors contributed to the industry’s downturn. They include rising drug costs, changing consumer habits and the emergence of online pharmacies.

But none looms larger that the outsized influence of pharmacy benefit managers. These third-party administrators of health insurers’ prescription drug programs have eroded the profits of retail pharmacies to the point where they now lose money on many sales.

Pharmacy benefit managers, commonly referred to as PBMs,…negotiate drug prices with manufacturers, determine which drugs will be covered by insurance plans and set reimbursement rates for pharmacies that buy and sell the drugs.

As the power of PBMs rose over the years, they demanded bigger rebates from drug manufacturers and pocketed increasingly bigger shares of those savings instead of passing them along. They also lowered reimbursement rates and tacked on hefty fees known as Direct and Indirect Remuneration.

While PBMs’ collective profits skyrocketed over the past decade, their tactics plunged retail pharmacies into financial distress and left them scrambling for alternative sources of revenue. The Federal Trade Commission launched an inquiry last year into PBM practices, which have already been the subject of several lawsuits.

Independent pharmacies have been hit especially hard. Not only are their reimbursement rates lower than those of chains, but their patients have been steered away by PBMs that insist they use a preferred chain pharmacy instead.

Other independent pharmacies simply closed.

Now the chains are following suit. CVS, Walgreens and Rite Aid all recently announced the closure of hundreds of pharmacies as they face slumping revenues and the fallout from multiple lawsuits for their alleged roles in the nation’s opioid crisis. Rite Aid filed for bankruptcy earlier this month.”

Ordinarily I would not include such extensive excerpts from another publication about situations that are so well known to pharmacists and that many are personally experiencing. However, what I have included is just a fraction of the USA TODAY coverage that also includes commentary on “Pharmacists bleeding, crying, working alone,” as well as issues such as pharmacists leaving the profession and plummeting enrollments at many colleges of pharmacy.

Emily Le Coz has provided exceptional coverage of the risks for patients and the concerns of pharmacists in her report, and also very effectively identifies and connects the multiple factors that create and exacerbate the current challenges. Although her report focuses on problems, it is not until the problems are well understood by the public and our legislators that our profession will be effective in developing and implementing solutions. I encourage you to access and read the entire report, and use the coverage of her objective “outside” observations to support your personal relevant experiences in messages with your community and local media.

The Ohio Capital Journal

Over a number of years, Marty Schladen has provided extensive coverage of pharmacy-related issues for the Ohio Capital Journal and previously for the Columbus Dispatch. His investigations were important in determining that in 2017, PBM middlemen and “secondary middlemen” charged Ohio $224 million more for drugs dispensed to participants in the Ohio Medicaid program than they paid pharmacies. The Ohio attorney general filed lawsuits that resulted in large settlements with certain of the middlemen (please see the August 2023 issue of The Pharmacist Activist).

Schladen has recently investigated and published in a series of reports about numerous errors and violations at CVS stores that were documented in Ohio Board of Pharmacy inspector reports. The Ohio Board held meetings on November 7-8 and Schladen’s excellent coverage and selected excerpts include:

November 8, 2023: “CVS disciplinary hearing before Board of Pharmacy begins.”

“With $2.3 billion in profits in the third quarter, CVS continues to boast to shareholders about its financial performance. But it apparently doesn’t want current and former employees to talk to state regulators about what goes on in its pharmacies. It filed motions to quash Board of Pharmacy subpoenas for those employees to testify in this week’s proceedings. The motions failed.”

November 9, 2023: “Ohio pharmacy board members seem skeptical of CVS claims.”

“Henry Appel, principal assistant Ohio attorney general, is prosecuting CVS in the administrative proceeding. He wants to subpoena the company’s custodian of records in an attempt to get copies of written communications between the Canton’s CVS pharmacy manager and her supervisors as problems spiraled in 2021. Dahmann (the CVS attorney) resisted first by refusing to give the records custodian’s name out of concerns for ‘personal confidentiality.” She then argued that some of the relevant CVS entities are ‘foreign’ companies domiciled in Rhode Island and Connecticut and thus are not subject to subpoenas from Ohio’s pharmacy regulator.”

“The hearing won’t resume until the Board’s December meeting at the earliest.”

November 30, 2023: “Still more Ohio CVS pharmacies accused of staffing-related problems.”

“In hearings into conditions at one of its Ohio stores, lawyers for pharmacy giant CVS last month told regulators that problems were due to understaffing and extra tasks imposed by the coronavirus pandemic. But the Ohio Board of Pharmacy continues to find such problems – which could threaten patient safety – at CVS stores across Ohio. Some were found as recently as late September.

“The most recent citations accuse CVS of improper handling of dangerous drugs, dirty conditions and six-day backlogs in filling prescriptions. As it has previously, CVS called the findings ‘isolated incidents.”

Marty Schladen understands and clearly articulates how pharmacy workplace conditions, errors, and violations are related to the policies and compensation/economic practices of PBMs that increase the risk of errors for patients, moral injury for pharmacists, and the financial survival of pharmacies. His recent commentary, “Pharmacy middleman grants huge bonuses for winning business meant to help the poor,” (November 17, 2023) begins:

“Medicaid might be a taxpayer-funded health program for the poor, but that doesn’t mean others aren’t getting rich off it – including employees of a company the state is suing on antitrust grounds. Several employees of drug middleman Express Scripts last year raked in bonuses of $750,000 each for getting the business of a managed-care company that depends on Medicaid for the bulk of its business.

In other words, in addition to their already-high pay, they received bonuses that were 18 times the average American’s annual pay just for landing a contract. And that contract is with a company that has already paid out $88.3 million to settle claims that it had defrauded the Ohio Medicaid program.

It might be striking to the average taxpayer that people with huge corporations are profiting so lavishly off of programs for the poor.”

Numerous other publications have also recently reported on the concerns of pharmacists and the risk to patients that result from the corporate dominance of pharmacy and other areas of health care. As examples, recent articles in The Wall Street Journal address issues about PBMs, health insurance companies, and pharmaceutical companies:

“Pharmacy Benefit Managers Under Fire:” (November 22, 2023; Melanie Evans);

“Senators Seek Probe of Insurers, Drug Prices:” (November 24, 2023; Joseph Walker);

“Cigna, Humana Explore Gigantic Merger:” (November 30, 2023; Lauren Thomas, Anna Wilde Mathews, Laura Cooper).

The possible merger between Cigna and Humana, which are already among the largest health insurers, has the potential to further reduce competition and increase corporate influence/control of the healthcare system. If the companies’ discussions progress in this direction, a merger would probably be challenged by the Federal Trade Commission (FTC) which is already investigating anticompetitive actions and programs of merged/acquired healthcare companies that were previously approved. There is bipartisan interest and concerns regarding the issues being addressed by the FTC, as well as legislative proposals designed to correct current problems. However, we must never underestimate the ability of the corporations such as PBMs to identify and exploit loopholes in any legislation and manipulate them to their advantage. This makes it all the more important that the public, legislators, and government officials have a clear understanding of the present concerns and consequences for the purpose of constructing legislation and taking actions that will be most effective in providing impactful reforms of our current healthcare system. If substantial reforms are to be achieved regarding pharmacy-related issues, our profession must give a very high priority to assuring that the public, legislators, and other decision-makers have a full understanding of our concerns and their risks/consequences, as well as the urgency for reform. It is in this direction that investigative reports of Emily Le Coz, Marty Schladen, and others are of great value in increasing the awareness and understanding of the public of the issues that place them at risk of harm.

Building momentum

Emily Le Coz’s investigations involved interviews with numerous pharmacists which increased the scope and depth of her coverage. Among those whom she interviewed are Michael Hogue, CEO of the American Pharmacists Association (APhA), and Doug Hoey, CEO of the National Community Pharmacists Association (NCPA). They are the leaders whom the media contact at an early point in their investigations of pharmacy-related issues, and they have been widely quoted in recent media coverage. These interviews, as well as those with other pharmacists have great benefit not only for increasing the awareness of the public of our concerns, but also their awareness of our associations and their programs and activities which are of importance for the public. The formidable challenges continue and may seem impossible to resolve, but I am impressed and encouraged by recent actions of our associations, as well as many individual pharmacists.

In addition to their support for pertinent legislative proposals, the associations’ concerns about the anticompetitive actions of health insurers and PBMs have been widely communicated. At its annual meeting in October it was announced that NCPA is working with three law firms in creating a limited liability company called TRUST LLC (www.fightPBMs.com), which will investigate and, when appropriate, litigate or arbitrate on behalf of community pharmacists to recover coerced price concessions (DIR fees) which have been assessed by PBMs and insurance plans and appear to be in violation of federal antitrust law and state contract laws. It has also been recently announced that Matt Osterhaus of Iowa is the lead pharmacist in a class-action lawsuit against CVS Health, CVS Caremark, and Aetna.

The APhA has established several programs to document unacceptable workplace conditions and to support the well-being of pharmacists. CEO Michael Hogue has recently stated that: “The APhA has been focused on longer-term fixes, and what we’ve heard loud and clear is we need to focus on the acute problems. That’s what we are going to do.” Hogue has met with CVS pharmacists who participated in the walkout of numerous CVS stores in the Kansas City area in protest of understaffing and stressful working conditions. The actions of these courageous pharmacists have resulted in wide media coverage and has provided the impetus for subsequent walkouts and initiatives to start a pharmacy guild. On October 30, Michael Hogue released a statement regarding the challenges for pharmacists, and excerpts are provided below:

“APhA stands with every pharmacist who participated in the walkout today.

For years, you have dealt with workplace issues, leading to frustrations and burnout, affecting your mental health and well-being.

While today Walgreens and CVS pharmacies are the focus of attention, I’ve also seen and heard clearly that corporate chain pharmacies are not the only place where pharmacists are being asked to work without adequate staff. I’ve heard from pharmacists in hospital outpatient pharmacies, federal facilities, and mail facilities about the same burnout from inadequate staffing.

In many ways, the recent headline of a USA TODAY story is true, our pharmacy system is broken.”

“For far too long, employers have made the situation worse than it needed to be. Supervisors who are not pharmacists do not understand the needs of care teams and make unreasonable demands on time-based productivity. Quotas on the number of prescriptions filled per hour or vaccines administered per day, or even time to answer the phone, simply fail to recognize that the pharmacist-patient relationship is not transactional. It is a special covenant – and supervisors who distill everything down to numbers and time metrics are destroying that relationship in the name of profitability. This must stop immediately. Employers should ensure supervisors clearly understand the covenantal pharmacist-patient relationship and that systems support this relationship fully. I again call on all employers to act swiftly on these issues that your pharmacy staff has made clear that they will no longer tolerate.”

“I’m also calling on CVS/Caremark, Express Scripts, Optum and all other PBM companies to immediately cease the assessment of DIR fees on retail prescriptions and ensure your contracts result in payment to pharmacies of at least their cost for the medicine they are providing plus a reasonable fee for doing so. You are breaking the backs of community pharmacists and are ultimately complicit in the workplace issues I am describing. Your corporate policies are unfair, restrict trade, and are causing the closure of hundreds of pharmacies across America. You are worsening health disparities and creating a new health emergency.”

This is, by far, the strongest and most direct position I have seen from APhA regarding the challenges that threaten future opportunities and accomplishments in our entire profession. Pharmacists in every area of responsibility must support these positions, and synergies can be achieved by close working relationships with media personnel in increasing public awareness of the concerns that place them at risk.

We must build on the momentum that currently exists!

CVS launches new pharmacy reimbursement model, brand for health services segment

This article was published in DRUG STORE NEWS, which is a industry journal. Many in the medical care industry is expanding their scope of services that they provide under one corporate banner. This is known as vertical integration.  While this article is sprinkled with the term “pt care”.  I have highlight some of the text from this article. That suggests to me, this whole new medical care model, is CVS’ intentions to attempt, as much as possible, once any part of CVS Health system cares for a pt’s health needs that they will refer the pt to other parts of the CVS Health system for generating additional revenue for CVS. By having their own employees recommend/prescribe additional health services, that parts of CVS Health provides.  I have stated many times before, that our entire healthcare system is nothing more, nothing less than a FOR PROFIT BUSINESS.

CVS launches new pharmacy reimbursement model, brand for health services segment

https://drugstorenews.com/cvs-launches-new-pharmacy-reimbursement-model-brand-health-services-segment

CVS is introducing CostVantage and Caremark TrueCost to drive aligned incentives and deliver a more transparent and sustainable reimbursement model.

CVS Health introduced a new pharmacy reimbursement model, and brand for its health services segment that showcases continued growth opportunities for its businesses.

CVS Pharmacy also announced CostVantage, a new approach that evolves the traditional pharmacy reimbursement model and brings greater transparency and simplicity to the system. CVS CostVantage will define the drug cost and related reimbursement with contracted pharmacy benefit managers and payors, using a transparent formula built on the cost of the drug, a set markup and a fee that reflects the care and value of pharmacy services. These changes also help ensure that CVS Pharmacy locations will continue to be a critical touchpoint for consumers to access affordable health care in their communities, the company said.

“We are successfully executing on our strategy to advance the future of health care while unlocking new value for consumers,” said Karen Lynch, president and CEO of CVS Health. “The combination of our businesses, and the key growth areas we have invested in, drive our ability to lower the total cost of care, improve health outcomes, and deliver on our commitments to our customers, consumers, and shareholders.”

“We are leading with an approach that will shift how our retail pharmacy is compensated by implementing a more transparent and sustainable model that fairly aligns pharmacy reimbursement to the quality services we provide,” said Prem Shah, executive vice president, chief pharmacy officer and president, pharmacy and consumer wellness at CVS Health. “It provides our PBM and payor clients a foundational step towards more pricing clarity for consumers.”

CVS Pharmacy plans to launch CostVantage with PBMs for their commercial payors in 2025, working together to ensure a smooth transition.

The company said that following on from the launch of its Choice Formulary program earlier this year, CVS Caremark today introduces TrueCost, a model innovation that offers client pricing reflecting the true net cost of prescription drugs, with visibility into administrative fees. Simplified pricing will help consumers be confident that their pharmacy benefit is providing the best possible price and will allow members to have stable access to its national pharmacy network. Through this approach, clients will have the flexibility to choose a pharmacy benefit model that works best for the unique needs of their members and plan, and CVS Caremark TrueCost provides another valuable option for them. CVS Caremark plans to launch CVS Caremark TrueCost in 2025.

To help demonstrate the connection and convenience CVS Health uniquely delivers, CVS Healthspire will be the new branded name for the company’s Health Services segment, including Caremark, Cordavis, Oak Street Health, Signify Health and MinuteClinic. The groups within CVS Healthspire will continue to focus on integration across the company’s assets to deliver connected patient care, pharmacy benefits and innovative provider support solutions in communities across the country, making expert care simple, more accessible, and more affordable. 

The CVS Healthspire brand will begin to roll out publicly this month and advance throughout 2024. Consumers will initially see “Part of CVS Healthspire” appear on select CVS Health care delivery offerings across digital and physical assets as the company continues to create an integrated ecosystem for patients.

“Delivering care in a more integrated way – especially for complex patients with chronic health conditions – improves health outcomes and the patient experience,” said Mike Pykosz, CEO of Oak Street Health and interim president of Health Care Delivery. “We are already seeing the benefits of our value-based model to lower the total cost of care for customers, clients, and patients, and we believe we will build on these results as we more fully integrate with our core businesses.”

While CVS Health’s business segments continue to be successful and profitable on their own, there is a sizable opportunity to continue strengthening these connections and create incremental value for the overall company, CVS Health said.

[Read more: CVS Health report highlights need for expanded role of retail pharmacists]

CVS Health provided the example of the recent improvement of Aetna’s Medicare Advantage Star Ratings. In just a year, by leveraging the power of the company’s cross-enterprise assets and executional excellence, Aetna was able to achieve 87% of their members in four star plans or better for the 2025 plan year, a recovery from 21% in the previous year, the company said.

“This achievement was due to the work across our Aetna, CVS Pharmacy, and CVS Caremark colleagues. Even more important than our ratings, these teams worked together to help members improve medication adherence and overcome barriers such as costs and transportation,” said Lynch. “Our strong performance in this area shows how we can quickly unite our businesses to achieve important common goals.”

CVS Health interim chief financial officer Tom Cowhey today will detail the company’s 2024 financial outlook, capital deployment strategy and long-term outlook and growth targets. The company’s unique combination of assets provides CVS Health with clear opportunities for long-term outperformance, including through Medicare Advantage margin recovery, incorporating Star Ratings, starting in 2025; CVS CostVantage, the company’s new retail pharmacy pricing model; increased patient enrollment in Oak Street Health; expanded product offerings through Signify Health; and enhanced growth in core businesses from new offerings in healthcare delivery.

“By broadening our portfolio of integrated products and services, we expect to create a path to sustainable, profitable growth,” Cowhey said. “Our powerful cash generation capabilities will support our strategic goals, prudent capital deployment, and attractive return profile – while also providing opportunities for meaningful long-term outperformance.”

Bossier City CVS pharmacy shut down amid DEA investigation

Bossier City CVS pharmacy shut down amid DEA investigation

https://www.shreveportbossieradvocate.com/news/bossier-city-cvs-pharmacy-shut-down-amid-dea-investigation/article_30b06a92-9399-11ee-befa-53809e1d2b32.html

The CVS pharmacy location on Barksdale Boulevard in Bossier City,LA is not serving patients amid a Drug Enforcement Administration investigation.  

The location’s pharmacy is closed as DEA agents and Bossier City Police are on the scene.

Representatives of CVS have not yet responded to requests for comment.

This is a developing story and will be updated as more information is discovered. 

US drug shortages are forcing ‘impossible choices’ for Americans, experts tell Senate committee

I find this article while starts out interesting and ends up with a Dr. Inmaculada Hernandez, Ph.D. that starts overstating what pharmacies and wholesalers make on supply side of the prescription mark. According to this Dr’s professional information on LinkedIN https://pharmacy.ucsd.edu/faculty/hernandez. Apparently she got her Ph.D. in 2017, suggesting that she has only signed the back of a paycheck, unlike those – like me – who have been owned and operated their own business. Over the years, I have signed the front side of a lot more paychecks than I have just the back side of a paycheck. In our pharmacy’s peak years, I was signing nearly 500 paychecks per year.  Then started addressing the mark-up/gross profit of wholesalers and pharmacies, does someone who has never owned/operated a business, have a clue about overall business expenses and producing/managing a profitable business? The above graphic gives an example of the gross profit of various parts of the Rx distribution system.  Wholesalers are showing a GROSS PROFIT OF 2% and Pharmacies of 3%. The Insurance/PBM had a gross profit of 46%. Those two are lumped together, because the top FIVE PBM’S are owned by insurance companies.

The typical pharmacy has a underlying cost of $12-15$ in fixed overhead per Rx.  That covers rent, utilities, insurance, payroll and overall cost of operating a business. For a pharmacy to stay in business the final cost of Rx should start with $15 PLUS the cost of the medication. For some very inexpensive generics, the gross profit the pharmacy shows, for the uninformed could appear to be extremely high. The last independent pharmacy in an adjacent county to ours, closed down early this year – after being open for 70+ yrs – because the pharmacist owner stated in the media that the PBM’s were paying less than it cost her to buy the medication from the wholesaler on 50% of the prescriptions that she filled.

I wonder why this particular “expert” did not STAY ON TOPIC in the testimony before this Senate Committee? But now the Senators on this committee, got a very inaccurate information about some of the costs/profits within the Rx medication distribution system.

US drug shortages are forcing ‘impossible choices’ for Americans, experts tell Senate committee

https://www.cnn.com/2023/12/05/health/us-drug-shortages-forcing-impossible-choices/index.html

As director of the Lymphoma Clinical Research program at M.D. Anderson Cancer Center in Houston, Dr. Jason Westin regularly witnesses the power of lifesaving cancer drugs. But because generic cancer drugs are often in shortage in the United States, he says, he and his patients have been put in a terrible position.

“The absence of a generic and cheap drug like fludarabine literally can be the difference between life and death,” Westin told members of the US Senate Committee on Finance at a hearing Tuesday.

The committee has been investigating a record shortage of drugs, a problem that’s been going on for decades and is unique to the United States, studies show

Several senators said they’d heard from constituents who are sick or who have patients hurt by these shortages. Sen. Marsha Blackburn noted that the medical center at Vanderbilt in Nashville has had to dedicate more than 100 staff members to managing and mitigating disruptions caused by shortages.

“This is something that is becoming all too common with our providers,” the Tennessee Republican said Tuesday.

The majority of the nearly 200 ongoing shortages – 84% – don’t involve new or novel drugs but rather generics that have been on the market for decades, said Sen. Mike Crapo, R-Idaho. Generics make up 9 of every 10 prescriptions filled in the US, so shortages have a big impact on the country’s health.

“These shortages can inflict drastic harm on massive populations of Americans,” Crapo said. “The average shortage affects at least half a million consumers, forcing them to scramble for viable alternatives or they’ll forgo treatment entirely.”

Many of these generics treat cancer. Fludarabine, a reliable drug used as a part of CAR T-cell therapy, is in shortage now, according to the US Food and Drug Administration. As with a lot of generic drugs used to treat cancer, it has been on and off the list for a few years.

For Westin and his colleagues, patients with rapidly progressing aggressive blood cancers don’t have time to wait for a drug to come back in stock. There’s only a narrow window in which they are well enough to get a potentially lifesaving CAR T-cell therapy, something that works only with fludarabine. There is no alternative, Westin told the committee.

“My colleagues have been forced to make impossible choices, including to choose which patients will be prioritized to receive potentially curative therapy,” he said.

“We know how to treat cancer, but shortages force impossible choices,” he added. “We have drugs that are lifesaving and shortages that are life-threatening.”

A large part of the problem with generics is that they have razor-thin margins and little profit to show for them, so companies often aren’t interested in making them. The number of companies exiting the market to make these drugs exceeds the rate of those entering the market by upwards of 40%, Crapo said.

Much of generic manufacturing gets outsourced to other countries like China and India, which can present geopolitical problems as well as quality-control issues, noted Dr. Inmaculada Hernandez, a professor in the Division of Clinical Pharmacy at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California in San Diego.

“We have a drug supply chain that heavily relies on foreign manufacturing. This is a national public health risk,” Hernandez told the committee.

One solution would be for the government to use value-based payments to incentivize large buyers of generics like pharmacies and hospital systems to purchase medicine from manufacturers with more dependable supply chains, she said.

Makers of generic drugs don’t have to share information about the supply chain, so buyers currently choose based only on price.

To truly end shortages, the Centers for Medicare & Medicaid Services, the nation’s largest purchaser of drugs, would have to be able to buy based on manufacturing quality and reliability, not just on price, said Dr. Marta E. Wosińska, an economist and senior fellow at the Brookings Institution.

“If we start rewarding reliability, manufacturers can maintain actually a higher price point because it’s rewarded, that reliability. Then there’s going to be an incentive that will follow,” Wosińska testified Tuesday.

In other words, more companies would get into the generics business.

Another problem the government would have to overcome, experts testified, is the consolidation of generic drug purchasing among a “small group of very powerful health care middle men,” said Sen. Ron Wyden, D-Oregon. Although there is money to be made in generics, it’s going to these middle men – drug wholesalers and pharmacy benefit managers or PBMs – rather than to manufacturers.

“There are many companies that manufacture generics, but they must compete for the attention of highly consolidated middle men,” Wyden said. Three drug wholesalers control 90% of the nation’s pharmaceutical market, he said.

“The generic manufacturers that are awarded contracts by these middle men do so by offering penny-on-the-dollar prices,” Wyden said.

Offered such low prices, companies don’t earn enough to invest in capacity or in equipment that’s key to making reliable high-quality medicines.

“So you have, in effect, a race to the bottom price for generics that leads to quality control problems and factory shutdowns,” Wyden said.

These “middle men” have also received criticism for driving up drug prices. In a study published Tuesday in the journal JAMA, Hernandez and her co-authors say that PBMs often pay pharmacies “unjustified excessive amounts for generics, as high as 10 times acquisition costs,” which the PBMs then recover through clawbacks rather than passing on to customers.

Hernandez told the Senate committee that of the top 50 generic drugs paid for by Medicare Part D, 16 were marked up 1,000% or higher. For aripiprazole, an antipsychotic drug, pharmacies paid an average of 17 cents per tablet; Rite Aid’s pharmacy benefit manager paid $11.70 per tablet, a 7,000% markup.

“So they end up paying much more than, actually, the pharmacy paid for the drug, let alone the manufacturer got for it,” Hernandez said.

Hernandez said she recommends greater oversight of PBMs. Legislation currently before the Senate would make it illegal for PBMs to engage in “spread pricing,” in which companies charge payers and health plans more for a prescription drug than what they reimburse the pharmacy, and the PBM pockets the difference.

Until there is some kind of legislation that addresses drug shortages, Wosińska and the other experts agreed, they will continue.

“What is vexing about these shortages is that they’re largely avoidable,” Wosińska said.