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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
https://www.pharmaciststeve.com/wp-content/uploads/2023/11/kaiser.pdf
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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.
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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/
“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.
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I have read about rumors that Pres Nixon in passing and signing the CSA bill into law, had Congress put in some “special language” in the bill that would make the law more difficult to repeal or change. Back in 1969-1970, it was believed that addiction was a choice and not a medical/healthcare issue. So the logic was that since addiction was a choice, Congress labeled it as a legal matter, so Congress gave the enforcement of breaking this law to DOJ… so the only “tool” that DOJ had in their “toolbox” was jail or prison. The DOJ stopped reporting how much they were spending in fighting the war on drugs as the total cost approached 100 billion/yr. The last estimate that I have seen in the cost of fighting the war on drugs is in the 120-140 billion/yr. Since the primary function of a bureaucrat is to perpetuate and grow the bureaucracy that work for. I have seen reports that when Congress created the DEA in 1973 with 43 million/yr & 1200 employees. That means in 50 yrs, the DEA budget has only been increased 3,333 times from where they started. Since over the last decade, the number of people being poisoned/OD’d for illegal opioids is up 6-7 times. Which would suggest that the DEA has been a complete failure at the charge they have been given.
https://www.acsh.org/news/2024/07/30/finally-someone-listening-people-pain-48900
As an unpaid healthcare writer and patient advocate, I’ve written for 27 years on opioid prescribing, pain management, and patient advocacy. Several of my shorter articles appear on Pain News Network or here on the American Council on Science and Health. Until recently, my work and that of many others had been met with official governmental silence (aka “stonewalling” by government authorities).
The silence might be about to change.
On July 23, 2024, I joined six other members of the Speakers Bureau of the National Campaign to Protect People in Pain, to offer a one-hour “listening session” to senior officials of the US FDA Center for Drug Evaluation and Research (CDER). A 25-page summary of the proceedings has been posted to social media platforms and shared with the US FDA Office of Communications, Professional Affairs and Stakeholder Engagement (PASE). Under the session rules, what follows below does not represent a commitment on the part of FDA, either to validate our stated findings or to take action thereon.
The one-hour FDA presentation was titled “The Real Opioid Crisis in Three Charts”. Our key points included these:
Findings briefed in the FDA Listening Session are being disseminated widely to US government Agencies including the National Institutes of Health, National Institute on Drug Abuse, National Centers for Injury Prevention and Control, and the Offices of the Surgeon General and the Inspector General in the Department of Health and Human Services. Online meetings are being requested with the Federation of State Medical Boards and all State Medical Boards, Boards of Pharmacy and Departments of Health.
It is time for the war on chronic pain patients, doctors and pharmacists to end. This Listening Session may be a first step in finally getting government authorities to hear our urgent pleas.
Richard A. Lawhern PhD is a volunteer subject matter expert on public health policy for regulation of prescription opioid analgesics and clinicians who employ them. Over 27 years, he has authored or co-authored over 250 papers, articles, and interviews in a mixture of peer-reviewed medical journals and mass media. He is also a member of the Scientific Advisory Board of ACSH,
The National Campaign to Protect People in Pain is an informal alliance of hundreds of experienced pain management clinicians, patients, family caregivers and advocates. The National Campaign is lobbying for major changes in public health policy governing the practice of pain medicine in America.
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In the 2020 Presidential election there was a total of 159 million votes for the two candidates for USA President. There is claimed that there is somewhere north of 100,000 people are dealing with chronic pain.
That number strongly suggests that regardless of what candidate one is talking about. If the chronic pain community got behind to dethrone an incumbent or elect a first time candidate for a city/county/state/federal office. If the community got united behind a particular candidate, that person would be elected or dethroned.
Over the last FOUR YEARS the CDC has stated that the number of our citizens that have been poisoned/OD on illegal Fentanyl from China and Mexican cartels is in the 400,000 neighborhood. The USA has only 47 cities with a population of > 400,000 people.
While there is no precise data on the number of chronic pain patients who have died specifically due to medication reductions or discontinuations over the last 4 years, this issue has been recognized as a serious concern:
## Impact of Opioid Prescription Changes
The CDC and FDA have acknowledged that abrupt or rapid discontinuation of opioid pain medications can lead to serious consequences for chronic pain patients, including:
– Severe withdrawal symptoms
– Uncontrolled pain
– Psychological distress
– Increased risk of suicide
In 2019, the FDA reported receiving reports of serious harm, including suicide, in patients who had their opioid medications suddenly discontinued or rapidly decreased[1].
## Unintended Consequences
The 2016 CDC guidelines on opioid prescribing, while intended to address the opioid crisis, had some unintended negative effects:
– Many doctors became hesitant to prescribe opioids, even to long-term pain patients
– Some patients had difficulty getting prescriptions filled at pharmacies
– Rapid tapering or abrupt discontinuation of opioids became more common
These changes left many chronic pain patients struggling to manage their conditions[2].
## Lack of Comprehensive Data
Unfortunately, there is no centralized tracking system that captures deaths specifically related to opioid discontinuation in pain patients. The full scope of this issue remains unclear due to:
– Difficulty determining cause of death in complex cases
– Lack of standardized reporting on medication changes prior to death
– Potential misclassification of deaths (e.g. as drug overdoses)
While exact numbers are unavailable, individual cases have been reported. For example, a man named Danny Elliott died by suicide in 2022 after being unable to find a doctor to continue his long-term pain medication[2].
## Recent Guideline Updates
In 2022, the CDC released updated opioid prescribing guidelines that aim to provide more nuanced guidance and reduce harm to pain patients. The new recommendations:
– Emphasize individualized patient care
– Warn about risks of rapid dose changes
– Acknowledge that some patients may benefit from long-term opioid therapy
However, experts note it may take time for these updates to significantly impact clinical practice and policies[2].
While the full human cost remains unknown, it’s clear that opioid prescribing changes have had profound effects on many chronic pain patients. Balancing pain management with opioid risk reduction continues to be a complex challenge for the medical community.
Citations:
[1] https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes
[2] https://www.cnn.com/2023/03/17/health/opioid-chronic-pain-cdc-guidelines-khn-partner/index.html
[3] https://www.mbc.ca.gov/Download/Publications/pain-guidelines.pdf
[4] https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm
[5] https://www.ama-assn.org/press-center/press-releases/report-shows-decreases-opioid-prescribing-increase-overdoses
[6] https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm
[7] https://www.ncbi.nlm.nih.gov/books/NBK537318/
[8] https://www.psychiatry.org/patients-families/opioid-use-disorder
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https://www.cato.org/events/pain-refugees-collateral-damage-war-drugs
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Next year, Medicare folks are going to get a break when they pay $2,000 out of pocket for medications and get ZERO COPAY after than point.
Have you ever squeezed a balloon? What happens, one part gets smaller and the other part gets LARGER?
I went out to www.medicare,gov website to see what was being offered. I just looked at premiums and deductible. That is the only thing that I can be comfortable that won’t change during 2025.
Come to find out, in 2024 our 12 monthly premiums and annual deductible was LESS than our DEDUCTIBLE WILL BE IN 2025
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