I have been nominated to be part of the Trump administration in regards to healthcare and MAHA

@everyone

https://discourse.nomineesforthepeople.com/t/steve-ariens/36342

 

Your support and votes are appreciated – see link above

Here is a video of a Federal attorney that elaborates how they use normally “innocent statements” from prescribers and pharmacist and daisy chain various otherwise “innocent activities” into violations of the Controlled Substance Act and the number of charges against the healthcare professionals start to stack up. US Attorney Admits that He was Directed to Target Doctors Who had NO criminal intent ( » US Attorney Admits that He was Directed to Target Doctors Who had NO criminal intent PHARMACIST STEVE )
Here is an article from FIVE SENATORS Elizabeth Warren Advocates to Formalize Barriers for Pain Patients » Elizabeth Warren Advocates to Formalize Barriers for Pain Patients PHARMACIST STEVE calling for the DEA to increase the DENIAL of pain medications to chronic pain patients. Here is a video on how the PBM industry now operates https://youtu.be/jp1_6SDfxlE?si=GCegamZsrAjGSmOV
Here is Senator Eliz Warren’s interaction with the CEO of United Health and all the control that they have over our healthcare system and all the profits they are taking out of our healthcare budgets, that should be devoted to pt care. If this group is hoping to improve pt’s QOL while controlling medical costs. It is going to need someone that understands where are the $$ are being sucked out of the system and to the bottom lines of many medical middlemen. I may be one of but a few people who can related to all those involved from the medical practitioner perspective and the pt’s perspective. I am retired and have no allegiance to any corporation and I have a wife that has been a intractable chronic pain pt for 3+ decades.

Image

Happy veteran’s day

Should we share the hell out of this?

I know that many of you are not happy in how the election turned out, but if you want to continue to put your personal political opinions over what is the best for the chronic pain community. You can stop reading right here ! Just go ahead and shoot yourself in the foot or HEAD!

There is a new sheriff in town and he is bringing along a lot of deputies that are claiming that they are making a change to how things are done.

Trump has admitted that some of the people recommended to him in his first term were not the appropriate people for the tasks they were given.  Perhaps many were covert members of “the swamp” that he was trying to drain.

I don’t think that Elon Musk,  Robert F. Kennedy Jr and whoever the new Attorney General will be of the previous SWAMP!

Musk claims he is going to focus on cutting costs – maybe he should look at all those 100 of millions of dollars being spent on Epidural Spinal Injection. That are not recommended by the FDA and the pharma that makes the corticosteroid most often used in ESIs. In reality those ESIs at best provide the pt some minor/temporary pain relief, but in the long run will cause more deterioration in the spine.

Those pain docs that are telling pts that they must be subjected to ESI to get some oral opioids, may be violating a federal law that is part of the Sherman Antitrust Act calling Tying Commerce https://en.wikipedia.org/wiki/Tying_(commerce) and providing those ESIs that are not really medically necessity, some consider it insurance fraud and if Medicare/Medicaid are involved then it could be considered federal fraud.

I read where – on average – TWO DOZEN – veterans commit SUICIDE EVERY DAY, because the VA system is refusing to treat those veteran who have come home with painful “broken bodies” and the VA system is just electing to ignore their pain.

Kennedy is suppose to be focusing on improving our health.  Could working with our new Attorney General to get the DEA to focus on getting much of the ILLEGAL FENTANYL off our streets and causing all those poisoning/ODs.

IMO, the only thing that may stand in the way of the community making some progress is to DO NOTHING! That will guarantee that the community will GET NOTHING! There is nearly 11,000 post on my blogs and I have pulled some that I consider very appropriate to work with the new administration.

https://www.pharmaciststeve.com/wp-content/uploads/2017/06/harmfrompain.jpg

 

Breaking: Supreme Court Rules ‘Red Flag’ Gun Laws Unconstitutional – should RED FLAGS used by DEA be UNCONSTITUTIONAL ?

US Attorney Admits that He was Directed to Target Doctors Who had NO criminal intent

Another reaction to the SCOTUS overturning the Chevron Doctrine

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

https://www.pharmaciststeve.com/wp-content/uploads/2023/11/kaiser.pdf

Could this be why no one can get a law firm to sue medical care deniers

Pain Refugees: Collateral Damage of the War on Drugs

SCOTUS Petition Takes Aim at Ambiguous Federal Opioid RX Laws Aug 5 Written By Ronald Chapman II Lubetsky v. United States

How opioid prescriptions are tracked and monitored by law enforcement and health care providers

 

 

Relax: Nothing is under control

Pin en El animal

Lauren Conrad Quote: “Sometimes, you just have to take a step back and ...

I have been writing/sharing on my blog for 13-14 yrs. I have seen many people who would come into the community the with attitude that they can “get ‘er done”.  They stay/hang around for a few months, maybe even a few years, and then they realize that the task is something that they can’t tackle, and they are GONE!

I have seen a lot of in-fighting within the multitude of “support groups’, even seen some support groups disband and then some of the fragments of those groups create another group or two and the cycle keep repeating.

I complained to Barb once many months ago, about all the infighting,  I married a very wise woman… she told me that I would never understand… because I never a girl/female in Jr/Sr High School.

Reading what those two attorney posted on the web over the last few weeks, it is posted below. I don’t think that the community will ever fine enough money to hire an attorney/law firm that has enough balls to address the problems with practitioners being able to  treat chronic pain and other subjective diseases, with the appropriate controlled medications.

Barb just had an appt with our PCP, who we have been seeing since last 1969 – early 1970. He is like a “Dr Marcus Welby” – if you don’t know the reference – do a web search. He is pulling back on his office hrs. He lost a adult kid to COVID-19 during the epidemic and he recently had some health issues where he was out of the office for a few weeks.

Years ago, he told the that  -God willing- he was going to be practice till he was 75 y/o.  But now he is about 70 y/o. I have an appt with him the first week of Feb, 2025. I will find out what his plans are.

We may be looking for a new PCP soon, but I know a number of the local prescribers and being a decent advocate, I think that we can hopefully transition over  to a new practitioner without missing a beat. Only time will tell.

IMO, the community has fragmented itself into many pieces or “tribes”, each with at least one Face Book page. Last week, I was not feeling very well one day and I just turned my phone off and shut my computer down.  The next morning, I found over 100 emails and I can’t count the number of FB posts – many of them repeats of people re-posting them in hopes that someone would read them. Then there was all the texts.

I have made nearly 11,000 posts on my blog over the years and it is approaching THREE MILLION PAGE VIEWS. I am approaching the end of my EIGHTH DECADE ON THIS PLANT.

Barb and I tend on aging in place, but I have not been able to find a “handyman” to do much of the maintenance around the house. I have the experience and the tools to do most all of the work, but my energy and endurance isn’t what it use to be.

Within the next few weeks, I will be pulling back from reading any of the Face Book pages and responding on those pages. I am still going to be around, and I can be reached via the links listed below. Chronic pain pts are still going to continue to get their pain meds taken away and they are still going to have to take a stand to get some of them back.

The path that the community may be on, may take longer than the number of years that I have left to try to change directions.  It looks like I may have other personal battles that I may have to deal with, and family comes first.

 

https://www.facebook.com/pharmaciststeve/

https://x.com/Pharmaciststeve

 

 

 

 

 

 

 

 


“Red Flag” Prosecutions against physicians continue. In United States v. Campbell, the Government used its unenumerated list of “red flags” to support a smoke-fire prosecution absent actual evidence. Tune into my 6th Circuit Oral Argument this Wednesday.


Could this be why no one can get a law firm to sue medical care deniers


November is Diabetes Awareness Month

Abandoned in Pain: A Family’s Fight Against UCHealth’s Neglect

Abandoned in Pain: A Family’s Fight Against UCHealth’s Neglect

https://www.coloradoswitchblade.com/p/abandoned-in-pain-a-familys-fight?triedRedirect=true

Exposing the Healthcare System’s Betrayal of Chronic Pain Patients—Share to Demand Accountability

This article is an opinion piece based on my personal experiences and interviews. The views expressed here are my own and do not necessarily represent those of any organization or publication.

I remember it was a cold and windy day as I helped my wife out of our beat-up grey Subaru. I got her walker from the trunk, carefully wrapping the blanket around her shoulders before helping her take each labored step toward the side door of our local medical clinic.

She had six broken ribs that day, a result of the life-saving CPR I had given her, along with the paramedics and the robotic Newton machine that continued compressions as they drilled an IV into her shin bones. It was the first time Shilo died in my arms.

We were lucky to get her back, but her survival was tenuous. For weeks, she hovered between life and death in a medically induced coma, her body battling cascading organ failure. The doctors told us to say goodbye. Those conversations with my daughters remain among the hardest of my life—second only to the next time Shilo died in my arms, this time for good.

Shilo had spent her life battling chronic pain caused by atypical Crohn’s disease and deep adhesion scarring throughout her abdomen. Her condition was so severe that even drinking water caused excruciating pain. For decades, doctors successfully managed her condition, giving her a semblance of normalcy that allowed us to build a life, raise our daughters, and hold onto hope.

Then everything changed. The very doctors and institutions that had cared for her abandoned her, citing fears of regulatory scrutiny and rigid opioid guidelines implemented by the CDC in 2016. When they stopped treating her pain, Shilo turned to alcohol for relief. I understood why—she was trying to numb the unrelenting agony—but I couldn’t allow it around our daughters. I found her an apartment close by, and though we were separated, we remained as close as ever.

After I was able to nurse Shilo back to health and convince her doctor to prescribe pain medication again, her recovery was remarkable. She moved back in, reconnected with our daughters in profound and meaningful ways, and grew closer to me than ever before. Those two years were truly a blessing to our family—two of the best years of my life.

The night she passed for the final time had started as a good day. We celebrated her birthday that weekend, cooked dinner together, and watched a movie. But later that evening, Shilo had her final seizure—the one she couldn’t wake up from.

That night, after the paramedics told me there was nothing more we could have done, I felt her spirit lift from her body. For the first time in decades, she was free from pain. I told her, “It’s okay. You can go. I’ll take care of the girls. You go, experience the universe without pain. I’ll see you when my own time is through.”


A Systemic Crisis

Shilo’s story is not unique. Thousands of chronic pain patients across the country face the same fate, abandoned by the healthcare system meant to protect them. This weekend, I was reminded of this cruel reality when my friend and pain management physician, Dr. Mark Ibsen, reached out with an urgent plea for help.

He told me about Monique Barela, a patient whose story mirrored my wife’s. Monique has been abandoned by her doctors despite her chronic pain being fully documented and protected under Colorado law.

“Monique doesn’t want to die,” her mother told me. “But she can’t live like this anymore.”

Monique’s desperation is not an isolated incident—it’s the result of a systemic failure to provide compassionate and competent care to chronic pain patients.


Monique Barela’s Fight for Survival

Monique’s battle with chronic pain began when she was just eight years old. A bacterial infection from a gym class injury led to years of surgeries, misdiagnoses, and escalating health complications. By her twenties, she was living with Complex Regional Pain Syndrome (CRPS), osteoporosis, and severe arthritis.

For a time, Monique managed her pain with carefully calibrated doses of oxycodone and oxycontin. With her pain under control, she was able to work two jobs and attend school. But in 2016, her providers began tapering her medication, not because her condition had improved, but in response to vague opioid-prescribing guidelines.

“They made me sign a taper form,” Monique explained. “They said if I didn’t, they wouldn’t prescribe anything at all. What choice did I have?”

Her once-stable life unraveled. Malnourished and in unbearable pain, Monique dropped to 87 pounds and was hospitalized. Even then, doctors dismissed her suffering. “They told me to try Tylenol or meditation,” she said, her voice trembling.


Abandoned by the System

Despite Colorado’s SB23-144—legislation explicitly prohibiting forced tapering and mandating individualized treatment plans for chronic pain patients—Monique’s cries for help have been ignored.

“I showed a doctor the law—SB23-144—to prove they wouldn’t get in trouble for treating me,” she recounted. “He refused to even look at it. He just walked out of the room.”

Even when Monique has found doctors still willing to help her, pharmacies have refused to fill her prescriptions, citing vague “red flag” policies. “I’ve driven hours to find a pharmacy that would give me what I need,” Monique said. “And most of the time, they still say no.”


The Insurance Ping-Pong Game

Adding insult to injury, many chronic pain patients are subjected to a cruel cycle of referrals and appointments with specialists who know they won’t provide treatment.

“Doctors know from the start that they’re not going to treat the patient’s pain,” Dr. Ibsen said. “Instead, they refer them to another specialist or clinic. It’s a cycle of false hope and wasted resources.”

Monique has lived this nightmare. “I’ve been sent to so many different clinics, and none of them ever actually treated me,” she said. “Meanwhile, my insurance gets billed for every appointment, every test, and I’m still left in pain.”

This practice raises serious legal and ethical questions. By repeatedly billing insurance for services that don’t address the patient’s needs, healthcare providers exploit the system while patients suffer.


A Call to Action

UCHealth has a choice: to honor the law and provide compassionate care or to perpetuate a system that abandons those who need it most.

To my readers: Speak out. Share Monique’s story. Demand accountability from UCHealth and other providers. Contact your legislators and insist they enforce SB23-144.

If this is an issue you or a loved one are facing, I urge you to contact Governor Jared Polis himself. He signed this law into effect, and it is failing our fellow Coloradans. Plead with him to demand accountability and ensure this legislation is upheld.

No family should endure what mine has. Shilo deserved better. Monique deserves better. Chronic pain patients deserve better.

Read the full text of SB23-144 here.


Shilo’s story, along with our family’s harrowing journey through the medical system as she faced chronic pain—her triumphs, setbacks, and ultimate sacrifice—will form the backbone of my next non-fiction book, currently titled Shilo’s Story. This memoir will explore our unconventional life together as creatives, artists, and writers while shedding light on our healthcare system’s systemic failures. It will highlight the resilience of those the system abandons and honor the enduring legacy of a woman whose courage continues to inspire. Stay connected for updates on this deeply personal and important project.

Major insurance companies focus on HEALTHY BOTTOM LINES!


Using a COLA calculator, a SINGLE DOLLAR in 2003 is $1.66 in 2023 dollars. These charts indicate that the major insurance companies have increased their profits and spending on lobbying by 5- 10 times what was done over two decades.  Does it seem that these insurance companies primary focus was on “healthy profits”?

The cost of HIGHER EDUCATION… is quite a BIT HIGHER!

To prove Pres Trump’s “facts”, I recently applied a COLA (Cost of Living Adjustment) to what my last year’s tuition at Butler U – my Alma Mater – was and the calculation was abt $6,000/semester in today’s dollars. My interest is because our only Grandson is headed off to college this time next year.

This year Butler U’s tuition is in the mid $25K/semester, and Pharmacy majors at Butler U – their tuition is HIGHER the last year of the 6 yr program.

Our only Daughter graduated from Butler U in 1993 – I think! As I Remember that her first year – Fall of 1989 .. total cost was abt $12,000 and her final year 1992-1993 was pushing $20,000 total.

Back in 1970, by working my ass off and pinching pennies, I was able to graduate with $500 in debt, which was about three weeks net pay that I got once I got my Pharmacist license. Today, it is not unusual for a newly minted pharmacist to leave college with a student loan debt approaching $200,000. Which is about THREE YEARS net pay once they get licensed.

How many Executive Orders can the Biden Admin sign into law before Jan 20th?

 

 

 

 

 

 

Does the World Health Organization work in our best interests?

EITHER YOU WILL CONTROL YOUR GOVERNMENT OR THE GOVERNMENT WILL CONTROL YOU

 

Ronald Reagan quote: Either you will control your government, or government will control you.

Would you believe: Federal regulators not properly doing their jobs?

The Anniversary of FDA’s Landmark Approval of Genetically Engineered Human Insulin: A Cautionary Tale

https://www.acsh.org/news/2024/10/24/anniversary-fdas-landmark-approval-genetically-engineered-human-insulin-cautionary

Regulators are supposed to abide by society’s “bargain” with them: Civil servants are granted lifetime tenure and protected from political pressure and retaliation, and in return, they are supposed to make decisions based solely on the public interest. Often, they do not.
Humulin vial, Wikimedia Commons, Creative Commons Attribution 4.0, Wesalius

Humulin vial

Next Tuesday, October 29th, marks the 42nd anniversary of one of biotechnology’s most significant milestones — the approval by the FDA of human insulin synthesized in genetically engineered bacteria to treat diabetes. The first “biopharmaceutical,” or drug made with molecular genetic engineering techniques, to be approved, it launched a revolutionary era in drug development. The event was prominently covered in the national press.

Insulin, which is secreted in the pancreas, is essential to the metabolism of carbohydrates and fats. Insulin deficiency leads to the development of diabetes. Many people with diabetes require regular insulin injections to maintain life and health.

As the FDA medical reviewer and the head of the evaluation team for “Humulin,” the brand name of the human insulin, I had a front-row seat. The saga is remarkable in several ways, not least because although both the drugmakers and regulators were exploring unknown territory, the development of the drug and its regulatory review progressed smoothly and rapidly.

Insulin in crude form was first produced a century ago, in 1922, by Canadian researchers Frederick Banting and Charles Best, which lifted the death sentence previously imposed on people with diabetes. By the end of that year, drug company Eli Lilly and Company had devised a method for much higher purification. But this ‘miracle drug’ was dependent on extracting the insulin from pigs and cows, using the waste products of the meat packing industry. According to the article in Diabetes Forecast, more than two tons of pig parts were needed to extract just eight ounces of purified insulin.

Over the next half century, the purified insulins obtained from the pig or cow pancreases, which differ slightly in chemical composition from human insulin, were constantly improved in purity and formulated in ways that offered physicians and diabetic patients greater control over blood sugar.

The extracted insulin was, almost literally, a miracle drug. It lifted the death sentence for insulin-requiring (Type 1) diabetics.

By the early 1970s, a crisis emerged: As the supply of animal pancreas declined and the prevalence of insulin-requiring diabetes grew, there were widespread fears of possible future shortages of insulin. Fortuitously, around the same time, a new and powerful tool — recombinant DNA technology, also known as “genetic engineering” or “gene-splicing” — became available, offering the promise of unlimited amounts of insulin that, unlike the insulin from animals, was identical to the molecule produced by humans.

The seminal molecular genetic engineering experiment was reported in a 1973 research article by academic scientists Stanley Cohen, Herbert Boyer, and their collaborators. They isolated a ringlet of DNA called a “plasmid” from a bacterium, used certain enzymes to splice a gene from another bacterium into that plasmid, and then introduced the resulting “recombinant,” or chimeric, DNA into E. coli bacteria.

When these now “recombinant” bacteria reproduced, the plasmids containing the foreign DNA were likewise propagated and produced amplified amounts of the functional recombinant DNA. And because DNA contains the genetic code that directs the synthesis of proteins, this new methodology promised the ability to induce genetically modified bacteria (or other cells) to synthesize desired proteins in large amounts.

Lilly immediately saw the promise of this technology to produce unlimited quantities of human insulin in bacteria. After obtaining the recombinant E. coli bacteria that synthesized human insulin from biotech startup Genentech, Inc., they developed processes for the large-scale cultivation of the organism (in huge fermenters like those used to make wine or beer) and for the purification and formulation of the drug.

Insulins had long been Lilly’s flagship product, and the company’s expertise was evident in human insulin purification, laboratory testing, and clinical trials. The company’s scientists painstakingly verified that their product was extremely pure and identical to pancreatic human insulin (which differs slightly in chemical composition from beef and pork insulin).

Lilly began clinical trials of its human insulin in July 1980. The product performed superbly. There were no systematic problems with treating “naive” patients (who had never previously received insulin injections) or those who switched from animal to human insulin. A small number of patients who had had adverse reactions of some kind to the animal insulins tolerated the human insulin well.

The dossier that provided evidence of safety and efficacy was submitted to the FDA in May 1982, where I was the medical reviewer and head of the evaluation team. Over many years, the FDA had prodigious experience with insulins and drugs derived from various microorganisms, so it was decided that no fundamentally new regulatory paradigms were necessary to evaluate the recombinant human insulin.

In other words, recombinant DNA techniques were viewed as an extension or refinement of long-used and familiar methods for making drugs. That decision proved to be a historic, precedent-setting – and correct.

Based on my FDA team’s exhaustive review of Lilly’s data, obtained from pre-clinical animal testing and later in clinical trials involving thousands of people with diabetes, the FDA granted marketing approval for human insulin in October 1982. The review and approval took only five months; the agency’s average approval time for new drugs was 30.5 months.

In retrospect, that rapid approval was particularly remarkable for a drug produced with a revolutionary new technology and that, after approval, would be available in pharmacies nationwide to millions of American diabetics.

The back story, however, is revealing. My team and I were ready to recommend approval after four months of review. But when I took the packet to my supervisor, he said, “Four months? No way! If anything goes wrong with this product down the road, people will say we rushed it, and we’ll be toast.”

That’s the bureaucratic mindset. I don’t know how long he would have delayed it, but when he went on vacation a month later, I took the packet to his boss, the division director, and he signed off.

That anecdote is an example of Milton Friedman’s observation that to understand the motivation of an individual or organization, you need to “follow the self-interest.” A large part of regulators’ self-interest lies in staying out of trouble. One way to do that, my supervisor understood, is not to approve a product in record time that might experience unanticipated problems.

The Humulin approval had significant effects. A front-page New York Times article quoted my prediction that the speedy approval was a major step forward in the “scientific and commercial viability” of recombinant DNA technology. “We have now come of age,” I said, and potential investors and entrepreneurs agreed. Seeing that biopharmaceuticals would compete with other medicines on a level playing field, the “biotechnology industry” was on the fast track.

Unfortunately, the rapid approval of human insulin proved to be an anomaly. Even with a toolbox of improved technologies available to both the FDA and industry, bringing a new drug to market on average now takes, on average, 10-12 years and costs, on average, more than $2.5 billion. There hasn’t been much improvement in review time from drug reviews in the pre-electronic era when New Drug Applications were submitted in paper form. (The paper pile for the review of insulin that my group performed was several times as large as that pictured in the FDA archive photo below.)

Regulators are highly risk-averse; few new drugs are approved without convening extramural advisory committees, and decisions are sometimes hijacked by political forces outside the FDA. Even so, five of the highest-revenue drugs in the U.S. in 2022 were produced by biotechnology, either with recombinant DNA or monoclonal antibody technology.

Other FDA-regulated biotech sectors have fared much worse. Regulators have made a colossal mess of regulating genetically engineered animals, which the FDA bizarrely chose to regulate as “new animal drugs” based on their interpretation of a 1938 law. That byzantine process led to a grotesquely prolonged, 20-plus-year review of a faster-growing Atlantic salmon.

More disarray occurred with genetically engineered mosquitoes to control mosquitoes that carry viral diseases: Inexplicably, it took the FDA more than five years to decide that, for regulatory purposes, this “gene drive” technology was a form of pesticide, and that jurisdiction belonged at the EPA. As a result of this bureaucratic bungling, the entire biotech sector of genetically engineered animals is moribund.

Government regulation has not aged as gracefully as genetic engineering technology, which has advanced significantly over the years. Regulators are supposed to abide by the “bargain” that society has made with them: Civil servants are granted lifetime tenure and are protected from political pressure and retaliation, in return for which they are supposed to make decisions based solely on the public interest. But, often, they do not.

To get FDA-regulated products to those who need them, congressional oversight must emerge from hibernation and create a healthier, more constructive balance.