DEA PROPOSED reduction in pharma controlled med production quotas

Proposed Aggregate Production Quota 2024 (2023-24282) DEA1228

https://www.regulations.gov/commenton/DEA-2023-0150-0001

Synopsis of the 3 major drug wholesalers agreement to reduce the controls sold to all pharmacies

I just wonder if the proposed reduction in pharma production quotas is just the DEA’s followup of the agreed upon reduction by the 3 major drug wholesaler – synopsis of agreement link above

That agreement, that was reportedly signed in April, 2022, was suppose to see the light of day, but was leaked in 2023.  I did not see in the nearly 600 page agreed if there was a specific reduction mentioned… just the wholesalers agreed to REDUCE controls sold to all pharmacies.  Could the DEA know what that percentage is going to be?

We have already heard of widespread lack of availability of control meds at local pharmacies. Is this the DEA CYAing the 3 major drug wholesalers, who agreed to reduce the number of controlled Rx meds they sell to pharmacies. Which in the end that reduction would have denied some disabled pts their medically necessary controlled medication.

Here is a post from last year – that some believe that the DEA is violating a federal law, by interfering with the availability of controlled meds by pts that a valid medical necessity and without them, their QOL will be compromised.

Is how the DEA enforces the CSA… in violation of this federal law ?

Of course, the entity that is in charge of enforcing our disability laws and civil rights law is our Federal Attorney General and the same entity is also the OVERSIGHT ENTITY of the DEA.

 

 

THE EXTREME PERSECUTION OF DR. SHIVE AKULA, MD., ADJUDICATED GUILTY FACING YEARS OF WRONGFULL IMPRISONMENT

Dr. Shiva Akula’s lawsuit details the conspiracy method and how the criminal indictment is purposed to eliminate Dr. Akula from the American healthcare market to permit his competitors to seize his business and personal assets.

THE PERSECUTION AND EXTREME MISCARRIAGE OF JUSTICE: DR. SHIVA AKULA, MD, KATRINA AND COVID-19 HERO OF NEW ORLEANS ADJUDICATED GUILTY (FACING 20 YEARS IMPRISONMENT)

Drugstore closures could make pharmacy deserts even worse

Drugstore closures could make pharmacy deserts even worse

https://www.cnn.com/2023/11/06/business/drugstore-closures-pharmacy-deserts/index.html

New York CNN  — 

With hundreds of pharmacies closing their doors this year alone, experts fear that more vulnerable Americans could be left without access to the medications they need.

Pharmacy closures have been a problem for years. CVS closed 244 stores between 2018 and 2020 and said in 2021 that it would close another 900 locations through 2024. In 2019, Walgreens said it would close 200 stores. This year, it announced an additional 150 closures. And Rite Aid recently filed for bankruptcy and announced that it would shutter about 100 of its roughly 2,200 stores as part of its restructuring efforts, with more closures to come. Brick and mortar pharmacies are facing a number of challenges: more competition, a tough few years stemming from the pandemic, and squeezed margins as reimbursement rates for prescription medications fall, due in part to how the business has changed.

When drugstores disappear, patients suffer, said Jenny Guadamuz, assistant professor at the UC Berkeley School of Public Health, Division of Health Policy and Management. “You can think of a closure as a disruption of care,” she said. “You had a routine: You would go to a pharmacy that was geographically accessible — ideally affordable — was probably preferred for your health insurance plan. And then that pharmacy is no longer there.”

A long way to go

When pharmacies close, some patients have to travel farther to get the medications they need. That extra distance and time often means they won’t pick up their medicine at all, Guadamuz said.

Melvin Thompson, now a healthcare consultant, was previously executive director of the Endelo Institute, a nonprofit organization devoted to health, education and community development on the South Side of Chicago, where he lives. Thompson said that since 2016, four or five major drugstores have closed in his area, and new ones haven’t opened to fill in the gap.

“To lose that first pharmacy was really a shock to the system,” he said. Some people have lost relationships with trusted pharmacists, or a nearby place to buy groceries. He’s noticed that because of the closures, people are traveling farther to get to drugstores. “We’re driving out of our communities to pharmacies miles away.” During the Covid pandemic, Endelo organized transportation to get seniors to pharmacies for vaccinations, he said.

Thompson, who himself lives close to a pharmacy in the South Side, said there is now more pressure on remaining locations. There are “lines for seniors out the door for prescriptions… and it’s the result of people now all going to the same pharmacy,” he said.

As major chains close their doors, the number of independent pharmacies in the United States has stayed pretty steady over the past three years, according to data from the National Community Pharmacists Association, which represents the interests of independent pharmacists. But chain closures aren’t likely to lead to more business for independents, which face challenges apart from competition from national chains.

The negative impact of this trend is most pronounced for minority groups. A USC study co-authored by Guadamuz that was published in 2021 found that Black and Latino neighborhoods in 30 US cities had fewer pharmacies than White and diverse neighborhoods from 2007 to 2015.

“If you’re located in a low-income neighborhood, and effectively in a Black and Latinx neighborhood, having any pharmacy is less common. And having a pharmacy that meets your needs is much less common,” she said.

In some areas, pharmacies do more than just fill medications. They “play a crucial role in the community,” said Omolola Adepoju, a health services researcher and clinical associate professor at the University of Houston’s Tilman J. Fertitta Family College of Medicine. “You don’t need an appointment to talk to a pharmacist,” she added. Patients can just walk in to get medications, vaccinations and answers to their questions, making pharmacies an “integral access point for primary care services for many underserved communities.”

In theory, Amazon or mail-order services could fill in the gap, delivering prescriptions directly to patients. But online pharmacies can’t administer vaccines, and not every medication can be shipped.

Plus, some patients may not have access to the internet. Even if they do, they might not trust online providers, fearing that a medication may have been exposed to extreme heat or otherwise compromised during delivery.

In some sectors, chain closures can open the door for more competition from local businesses. But market conditions in the pharmacy sector make it unlikely that independent pharmacies will be able to thrive.

Drugstore economics

Drugstores like Rite Aid and others have suffered from increased competition from online pharmacies and big box stores like Walmart and Target, which also fill prescriptions.

But some say that the major challenge to pharmacies has come from pharmacy benefit managers, or PBMs, which work as middlemen between different parts of the healthcare business, including insurance providers, drug companies and retailers.

PBMs are “a very, very powerful entity,” said Douglas Hoey, CEO of the National Community Pharmacists Association. “They control drug pricing, they control prescription drug reimbursement,” he said, adding that the groups also negotiate rebates and charge administrative fees. PBMs originally started in the 1960s as insurance claims managers and have evolved over time to manage more parts of the health care business.

The costs of doing business through a PBM can squeeze margins and sometimes put pharmacies in the red, Hoey said. And the impact on independents has been outsized because a higher percentage of their business comes from prescription drugs compared to national chains, he added.

Pharmacy benefit managers argue that they help keep drug prices down by negotiating with drug makers.

In September, the House Committee on Oversight and Accountability held a hearing about benefits managers, listening to testimony from those saying that the groups are driving prices up. During the hearing, JC Scott, president and CEO of Pharmaceutical Care Management Association, the trade group representing PBMs, said that “health plan sponsors, including employers, voluntarily hire PCMA’s member organizations to secure savings and provide choice and specialized expertise on pharmacy benefit design, coverage, and delivery.” He added that PBMs work with insurers to “secure lower costs for prescription drugs and achieve better health outcomes.”

But elected officials are skeptical: Legislation has been introduced to curb the power of PBMs, which lawmakers say are making drugs more expensive for customers.

These dynamics mean that reduced competition in the space is unlikely to benefit independents, said Hoey. What it might do, he said, is burden already overloaded pharmacists with new customers.

“I think we’ll see more… unacceptable experiences at the pharmacy,” Hoey said.

Recently, pharmacy workers have been staging walkouts over working conditions they say put patients at risk. Some have said that a focus on vaccination puts them behind on filling prescriptions, creating a stressful environment for workers and negatively impacting patients who need medication.

 

54 surgeries in 14 yrs of being on this planet

Most of us in healthcare have heard of RARE DISEASES, often that refers to so few a pts have been diagnosed with, that no pharma can afford to do the research to discover a medication to treat the particular health issue. Often Congress will pass laws to give a pharma generous tax incentives to find a medication to treat and/or manage the RARE DISEASE.

Poor little Emmalyn has been cursed with having been diagnosed collectively with several different difficult to treat health issues.

Emmalyn has been accepted at a clinic in Arkansas that specializes in treating pts like her, but she needs to raise $55,000.  American Pain and Disability Foundation helped raise the $2,500 DOWN PAYMENT and if she can manage to raise enough – total of $55,000. She will start treatment in this clinic early next year.

This clinic has pts come to it FROM ALL OVER THE WORLD. I am told that Emmalyn’s family has to raise this money because her health insurance is provided by the state of Arkansas and because of limited openings at the clinic and all the step therapy and prior authorizations requirements of her insurance, dovetailing the two together is nearly impossible.

 

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https://www.acmcrn.org/emmalyn-freeze

Emmalyn’s story begins with a diagnosis of Chiari Malformation with syringomyelia in 2012 at the age of 3 after a Chiari Decompression surgery to help drain the two syringes, one in her thoracic and a smaller one in her cervical region. Unfortunately, the surgery wasn’t successful, and Emmalyn went onto suffer many surgeries and procedures. It started with chemical meningitis, then being diagnosed with occult tethered cord in 2013, which led to the first of four detethering surgeries.

Emmalyn continued to suffer from headaches and leg pain for the next two years, which brought the third and final decompression surgery. Her thoracic syrinx had grown bigger, and they hoped to reduce its size. Her third decompression surgery happened in Nov of 2015. The decompression surgery seemed to have gone fine until December of 2015 when her grandma discovered a large bump on the back of her head that was squishy. She was diagnosed with a pseudomeningocele and that’s when things really went downhill due to the damage to her dura (lining of the spinal cord) which unleashed a series of devastating events.

Since Emmalyn’s original surgery in July of 2012, she has since endured three Chiari Decompression surgeries, a plate in her head to treat the Craniocervical Instability (CCI) brought on by a botched Chiari Decompression surgery, spinal fusion surgery throughout her cervical region, spinal fusion hardware removal, numerous infections, shunts,  6 CT Myelograms, 1 Cisternogram, several lumbar punctures, numerous MRI’s, blood patches, a fibrin patch, ICP bolts, anti-siphoning devices, EVD drains, numerous spinal fluid leaks from the back of her head to her lumbar, and because of her diagnosis of Ehlers Danlos Syndrome dural patches with muscle flaps and harvesting her own tissue, and this isn’t a complete list of all the procedures she has gone through. 

Here’s Emmalyn’s story as told by her mother, Stephanie Freeze:

Currently, Emmalyn has four shunts installed and continues to have serious spinal pressure issues and serious side effects from the massive scar tissue in her spine. Emmalyn deals with 10/10 lower back pain, 10/10 back of the head pain every day of her life at the age of 13 and does not have full use of her left leg due to a tremor that developed and has to walk with a cane.

If all of this wasn’t enough, Emmalyn was diagnosed on November 15th, 2021, with Adhesive Arachnoiditis by an astute neurosurgeon in Rhode Island. The neurosurgeon let us know that she has serious cauda tethering with a syrinx present and massive scarring. She also has an arachnoid cyst in her lumbar area and also explained that the terrible tremor she has in her left leg, which requires her to use a cane, is most likely due to AA. 

In June of 2022, her main neurosurgeon, made the decision that Emmalyn needed to undergo one more CT myelogram as leak symptoms were still on the rise. When the Myelogram was performed, they let us know there is an empty sac appearance to the distal thecal sac likely due to adhesions of the nerve roots. At this point the decisions were made that nothing should be done in the lumbar area unless absolutely necessary and that is when I started my research on Adhesive Arachnoiditis. When researching I realized how much had been done to Emmalyn’s spine that could have been avoided. I joined all the groups on Facebook and met wonderful people, including ACMCRN.org, that have been able to guide me through what this grueling and terrifying disorder that my 13-year-old daughter is facing.

I got in touch with the Tennant Foundation and started reading all the bulletins. I reached out to Dr. Tennant to see what his thoughts were, and he put me in touch with a doctor that could try and help Emmalyn. We have started medications to help her and have found out that she has intestinal malabsorption with opioids and that is why the meds were not helping her pain. The doctor put Emmalyn on Troque’s for medications so that they would help. We had MRI’s 2 months after being on the meds. The pain hasn’t really improved yet, but on the MRI’s the adhesions are improving and headed in the right direction that gives me hope. 

Emmalyn has been through 51 brain and spine surgeries in her life. More than any person should have to go through and unfortunately is not doing well at this point. Our next steps are driving to California from Illinois on February 4th to see Dr. Schievink. We have to drive as Emmalyn cannot take the 5-hour flight, as it causes her too much pain. She will undergo a MR Myelogram of the full spine and MRI of the brain with and without contrast and seeing Dr. Schievink the same day on February 9th. We believe Emmalyn has another leak or too many CSF diversions as she currently has 4 shunts. We absolutely have to get these pressure problems under control, and I believe things will head in the right direction. 

I have come to terms that my daughter has so many disorders that don’t have a cure and have met so many fighting this same battle. I advocate to other parents to please research, get all your questions asked and get many opinions. I am including Emmalyn’s published story, which she has endured 11 more surgeries since I wrote that story, and I am currently working to bring her story up to date. I am always here for anyone that has questions or may need to talk as this road is too long and hard to do alone.

Please read more of her story:  The Emmalyn Freeze Story – A Chiari Warrior’s Journey (Updated) – Chiari Bridges

Like many patients and parents of rare disease patients, Emmalyn and her family have traveled tens of thousands of miles in order to get answers and treatments for Emmalyn. They have flown on planes, which Emmalyn is no longer able to do, so now they drive in a car. They have had to incur the costs of hotels, food and drink, gas, and other incidentals. The cost of this is overwhelming for their family and they have had to rely on the generosity of friends and family. Would you consider giving a donation to the Sweet Emmalyn GoFundMe. Gift Cards can be sent to sfreeze02@gmail.com, along with any questions or comments you might have. The family does accept money orders and cashier checks.

Update to Emmalyn’s Story:

In the beginning of 2023, Emmalyn’s leg pain escalated, prompting Stephanie to seek solutions. She journeyed from Chicago to California for a specialized MRI and consultation with Dr. Tennant, an adhesive arachnoiditis specialist. The MRI unveiled a sizable growth in Emmalyn’s cyst, necessitating fenestration. This discovery led to another trip, this time to Durham, embarked upon on March 5th. On March 9, 2023, Emmalyn underwent a marathon 6-hour surgery. The procedure aimed to fenestrate the cyst, secure a shunt, and detether her lumbar spinal cord to alleviate leg pain. While it did alleviate lower back pain, the persisting symptoms included positional headaches and vomiting.

An infection on April 6th extended their stay, and although Emmalyn was discharged on April 11th, they didn’t return home until April 13th, amounting to a total of 37 days away. What was initially planned as a two-week endeavor was significantly prolonged due to circumstances.

Emmalyn’s health struggles persisted into April, prompting a return to Durham on April 22nd to consult her hematologist, followed by another trip on April 30th. Regrettably, her head pain endured. This led to a further trip to Durham on May 14th, as Hematology necessitated an additional appointment and referred her to Immunology. Neurosurgery aimed to address her severe head and neck pain.

An update on May 22nd from Emmalyn’s mom, Stephanie, indicated the need to reset Emmalyn’s shunt due to worsening pain. After weeks of unsuccessful attempts to adjust the shunt correctly, Dr. Grant sought consultation with the shunt manufacturers for a solution. Further trips were planned to Rhode Island and North Carolina for EDS pain management and comprehensive MRI scans of the brain and spine.

Despite their tireless efforts, Emmalyn’s condition did not improve. Dr. Grant’s consultations led to a high-stakes decision for a risky surgery on June 13th, with the goal of addressing tethering and cerebrospinal fluid blockage. This intricate procedure lasted around six hours. Complications necessitated an extended stay in North Carolina, beyond their initial expectations.

On August 10th, another procedure, a lumbar puncture, was conducted in a bid to uncover the cause of Emmalyn’s persistent head pain. Unfortunately, this procedure did not yield the desired results, prompting a MR Myelogram that revealed a significant spinal fluid leak. Surgical options are being investigated now.

Emmalyn’s relentless journey weighed heavily on her family, burdened by copays, medical bills, lodging, and travel costs. Throughout these trials, their spirits remained resilient as they yearned for Emmalyn’s recovery and her eventual return home, a goal they fervently hoped to achieve by the end of August.

If you find yourself moved by Emmalyn’s courageous battle and her family’s unwavering determination, consider sharing her story. Spreading awareness not only shines a light on the challenges faced by rare disease patients like Emmalyn but also offers a ray of hope in garnering support, both emotional and financial, during this challenging period. Your willingness to share her journey could make a meaningful difference and provide the essential aid that Emmalyn and her family need

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the “unholy alliance” between Vertex Pharmaceuticals, US Pain Foundation and lawmakers

This video is about the “unholy alliance” between Vertex Pharmaceuticals, US Pain Foundation and lawmakers; how they work together within the public, private – partnerships to create an illusion for the public in an effort to gain support. It is reminiscent of a theater act. In this video, I will show what happened behind the scenes, outside the public purview, examining all the strings that were pulled years before resulting in the changes in the healthcare system we are seeing today.

“THE FAT MAN”

 

Coley O. Reynolds, Esq, Atty for Dr. Neil Anand, MD

DATA ANALYTICS, PARALLEL CONSTRUCTION, EVIDENCE LAUNDERING, U.S. GOV. WARRANTLESS DATA MINING OF ELECTRONIC MEDICAL RECORDS FOR PATIENT INTERROGATIONS: UNITED STATES vs. DR. NEIL ANAND, MD.(FAT MAN)

“THE DAISY CUTTER”

FORBES MAGAZINE EXPOSES: “WARRANTLESS RAIDING OF MEDICAL RECORDS,” BY GOVERNMENT IN UNITED STATES vs. ANAND (2ND DOSE)

Pharma prescribed opioids to pts with valid medical necessity -0.022% pts OD’d

https://www.hrw.org/sites/default/files/report_pdf/hhr1218_web.pdf

I won’t go into a lot of horrific issues in the USA’s history. All the wars that we have gotten involved it or got drug into.  All drug overdoses have gone from about 14K to >110K AND GROWING.  “They” talk about OD/poisoning from fentanyl, seldom/never mentioning that the fentanyl analog involved is not approved by the FDA, making it ILLEGAL FENTANYL and never mention that there is some 1400 different known fentanyl analogs.

It is pretty much common knowledge where all those illegal fentanyl are coming from, China & Mexican cartels. The “bodies” attached to all those kilotons of illegal Fentanyl is pretty well known. What we don’t know is all the “bodies” attached to the 2016 CDC Opioid dosing guidelines.

Newest attack on chronic pain community by 41 State AGs that is going to be the next large attack on the chronic pain community  AGREEMENT

This agreement was apparently made in the spring of 2022, and was not suppose to see the light day,  but fortunately someone leaked it, around April , 2023.  The body count that this agreement is going to create, could make the CDC’s 2016 guidelines look like something developed by amateurs.

Coroners have in the past, disregarded deaths caused by under/untreated pain, that caused a untold number of deaths that were most likely labeled as “natural causes”. The deaths caused by the forceful tapering of a chronic pain pts pain medications may never be accurately measured.

 

Imagine: 14 y/o chronic painer that has already survived 54 surgeries

Credit to patient advocate Bob Sheerin
Little Emmalyn has been diagnosed with AA cyst and several auto immunes since 18 months old! She is now 14! She’s had 54 surgeries since birth & 4 brain surgeries just last year and a lumbar surgery in 2023! Sper0 Clinic in Arkansas is offering her placement in the program if $2500.00 can be met for down payment for a February 2024 start date! This program runs 40,000 and so many medical professionals are satisfied this program maybe so helpful to Emmalyns needs! This little lady is the most deserving young warrior and her and her mother fight so hard on both pain patients rights and the legislation side of things! Her personality is so contagious it’s amazing for a little lady that’s in so much pain! As much as she suffers and still finds the time to fight for others is an absolute inspiration to the medical field and to advocates everywhere! Let’s share this and show little Emmalyn her work and her suffering is all part of the plan to help others as well as herself! Plus trust me we want to get her better because she’s one heck of an advocate! #helpEmmalyn #Cppnation #apdf #showingcompassion #fightingtheimpossiblefight #apdfkids #chronicpain #illinoisdoctors

Profits should not be put ahead of pt & staff mental/physical safety

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