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Steve Ariens,P.D.
Chronic Pain Management Consultant
I asked this person the following question:
Finally, Someone is Listening to People in Pain!
Posted on October 31, 2024 by Pharmaciststeve
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.
Finally, Someone is Listening to People in Pain!
https://www.acsh.org/news/2024/07/30/finally-someone-listening-people-pain-48900
With “The Real Opioid Crisis in Three Charts,” a patient advocacy group has briefed senior FDA officials on major changes needed in public health policy for the regulation of prescription opioid pain relievers, and doctors who prescribe them. Perhaps now someone is truly listening to people in pain.
@Is someone finally listening?
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:
- If the FDA audience carries away nothing else from this session, they should remember this: There is no such thing as opioid use disorder. The term originated in 2013 with the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) – a document rejected by the National Institute for Mental Health as a framework for organizing research. Data published by the CDC itself completely discredits the notion that doctors prescribing to their patients are or ever were responsible for the US opioid crisis. And both CDC and DEA have known this reality for years.
- US CDC and US DEA are usurping missions delegated to the FDA by law, in the establishment of safety standards for prescription drugs. The consequence of this usurpation is the ongoing destruction of American pain medicine.
- CDC prescribing guidelines can be shown to incorporate outright fraud including failure to address genetically mediated opioid metabolism, misrepresentation of the effectiveness of non-opioid alternative therapies, one-size-fits all MMED dose criteria unsupported by science, and misrepresentation of opioid therapy, especially high-dose opioid therapy, as ineffective for long-term use.
- DEA prosecutions are grounded on non-representative “expert witnesses” who testify to anything DEA wants, no matter how false. Likewise, Administrative Law Judges deny defendants adequate representation by pre-trial asset confiscations and by rulings biased in favor of the DEA.
- It is now known beyond contradiction that incidence of addiction and overdose in pain patients treated by a doctor is too small to measure accurately within confounds of diagnosis and poor clinician training. Law enforcement is particularly ill-equipped to comment on this issue. It is also known to CDC and DEA that doctors overprescribing to patients was never a significant cause of the US opioid crisis — and is not now.
- Our speakers appealed to FDA to take public action to repudiate and demand the withdrawal of horrendously damaging injunctive relief provisions imposed by the National Opioid Settlement. We also encouraged the Agency to take immediate action to correct its own databases concerning shortages of prescription opioids created by the US National Opioid Settlement injunction.
- We asked FDA to publicly repudiate and demand withdrawal of CDC/VA/DoD opioid prescribing guidelines, without replacement. In a spirit of transparency, we also disclosed that stakeholder participants in the session are co-complainants in formal complaint actions filed May 21, 2024 with the US Department of Justice Office of Civil Rights and the Office of the Inspector General of DHHS. We allege criminal fraud and denial of US citizens’ civil rights on the part of CDC authors and approving officials for the 2016 and 2022 published opioid prescribing guidelines.
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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Chronic painers’ votes matter
Posted on October 30, 2024 by Pharmaciststeve
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.
Joe Biden 4 yrs ago
Joe Biden yesterday
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.
Apparently it is recognized that the CDC opioid dosing guidelines have had a significant impact on the chronic pain community, but little/no real interest in any attempt in tracking the number of citizens that have died as a result of those CDC guidelines.
how many chronic pain pts have died from having their pain medication reduced or stopped entirely over the last 4 yrs because of actions of the DEA
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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Pain Refugees: Collateral Damage of the War on Drugs
Posted on October 29, 2024 by Pharmaciststeve
Pain Refugees: Collateral Damage of the War on Drugs
https://www.cato.org/events/pain-refugees-collateral-damage-war-drugs
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what they give with one promise – they take away without mentioning it
Posted on October 28, 2024 by Pharmaciststeve
Medicare enrollment for 2025 now open
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
In 2025, our 12 monthly premiums and annual deductible will be 134% HIGHER. In 2025, together we will be paying > $1,000 more for 12 monthly premiums and annual deductible. Than we had to pay in 2024. Before we get the first $ in benefits.
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file a Constitutional Challenge to the 2016 Comprehensive Addiction and Recovery Act (CARA)
Posted on October 27, 2024 by Pharmaciststeve
An attorney IS NEEDED who would file a Constitutional Challenge to the 2016 Comprehensive Addiction and Recovery Act (CARA) which did the same thing the DEA is doing to data mine to prosecute doctors.
They are using “Summary Statistics” and the Bell Curve, and gave Medicare and the private corporations administering Medicare benefits the right to restrict access to opioids for all the “beneficiaries.”
All people taking opioids are now deemed “at-risk” for overdose and/or diversion, without any evidence, and, Medicare and the corporations administering Medicare benefits are using Summary Statistics and the Bell Curve to monitor patients whose doses fall outside the “normal use,” without any definition of what “normal use” is, other than asserting the Bell Curve and DEA Dose Caps.
You cannot put human beings taking opioids into a Bell Curve like that.
Some metabolize differently than others, some have conditions that require doses in excess of what “another person” would need.
It seems to me that a Constitutional Challenge needs to be filed, because this violates the 14th Amendment.
This provision of the CARA Act takes away “life, liberty, and the pursuit of happiness,” particularly LIFE, and this provision has
ACTUALLY KILLED AND IS STILL KILLING PEOPLE, due to medical complications and suicide after forced-tapers or sudden discontinuation of meds.
Everyone, please start contacting attorneys.
Send them this, and direct them to page 48 of the CARA Act.
THANK YOU!
David Smith … daveys35@gmail.com
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Tennant Foundation: PARTICIPANTS NEEDED FOR STUDY
Posted on October 27, 2024 by Pharmaciststeve
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Could this be why no one can get a law firm to sue medical care deniers
Posted on October 26, 2024 by Pharmaciststeve
Now the community knows why they can’t get any attorney to go after a healthcare corporation or prescriber for denial of care and/or intentionally put some pts in a torturous level of pain!
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There is a old saying….
Posted on October 26, 2024 by Pharmaciststeve
Quote Origin: If You Are Not a Liberal at 25, You Have No Heart. If You Are Not a Conservative at 35 You Have No Brain
There is also a old saying, with age, comes wisdom. – or is it common sense and many figure out that friendship is more important than some political beliefs?
Typically, good friends will have your back, politicians will lie to your face!
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The Whirlwind World of GLP-1 Medications for Treatment of Obesity and Diabetes
Posted on October 25, 2024 by Pharmaciststeve
The Whirlwind World of GLP-1 Medications for Treatment of Obesity and Diabetes
If you’ve been living under a rock for the past few years, take note that there are very effective medications used to treat obesity and type II diabetes. They include products with glucagon-like peptide (GLP-1) activity.
The two dominant players in the industry are Novo Nordisk and Lilly.
Novo Nordisk distributes semaglutide: Ozempic for Type 2 diabetes; and Wegovy, a higher-dose product, approved for weight loss.
Lilly distributes tirzepatide: Mounjaro for Type 2 diabetes; and Zepbound, a higher-dose product, approved for weight loss. Tirzepatide works by mimicking two gut hormones: GLP-1 and glucose-dependent insulinotropic polypeptide (GIP).
Normally, when a drug is approved, the pharmaceutical sponsor has monopoly rights to distribute. The branded pharmaceuticals of Novo Nordisk and Lilly are not cheap. A one month supply is typically $1,000. Or more. And depending upon the patient’s insurance, it may not be covered.
Because of such high demand, patients HAVE been able to obtain what they want. Actually, it’s more accurate to say because of limited supply, patients HAVE been able to obtain what they want.
When drugs are in shortage, compounders are permitted to sell versions of those medications ostensibly to ensure patients can continue receiving care. By outsourcing to compounding pharmacies, companies and medical spas have been able to circumvent Eli Lilly and Novo Nordisk’s exclusive hold on GLP-1 drugs.
Many medications are currently on the FDA’s shortage list. As of October 2024, for example, clonazepam tablets and cis-platinum injections are in short supply. Most patients are not rushing to compounders to fill that need.
Presumably there’s a common manufacturing pathway for the compounded medications and branded medications.
Patients who have been accessing compounded GLP-1 drugs have been paying as low as $100/month.
This sets the stage for Novo Nordisk and Lilly to ramp up manufacturing capacity to serve anticipated demand.
On October 2, 2024, FDA sent out a press release.
The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022 due to increased demand.
FDA confirmed with the drug’s manufacturer that their stated product availability and manufacturing capacity can meet the present and projected national demand. Patients and prescribers may still see intermittent localized supply disruptions as the products move through the supply chain from the manufacturer and distributors to local pharmacies.
FDA reminds compounders of the legal restrictions on making copies of FDA-approved drugs
Compounded drugs are not approved by FDA. FDA-approved drugs go through FDA’s rigorous review for safety, effectiveness, and quality as part of the premarket approval process. Compounded drugs must meet conditions to qualify for exemptions under sections 503A and 503B of the Federal Food, Drug and Cosmetic (FD&C) Act. Among the conditions are:
- Section 503A of the FD&C Act includes restrictions on compounding drugs that are essentially copies of a commercially available drug. When a drug shortage is resolved, FDA generally considers the drug to be commercially available. Certain amounts are permissible under the law as long as the compounding is not done “regularly or in inordinate amounts.”
- Section 503B of the FD&C Act restricts outsourcing facilities from making compounded drugs that are essentially a copy of one or more FDA-approved drugs. Among other things, this means the compounded drug may not be identical or nearly identical to an FDA-approved drug unless the approved drug is on FDA’s drug shortage list.
Current shortage status of GLP-1 products (as of October 02, 2024):
- Tirzepatide injection: Shortage resolved.
- Dulaglutide injection: In shortage.
- Semaglutide injection: In shortage. Manufacturer has reported all but one of the presentations are available.
- Liraglutide injection: In shortage. Manufacturer has reported 2 presentations are available, and three have limited availability.
The agency will continue to work with manufacturers to help resolve the current shortages, and, as shortages resolve, will closely monitor the situation and provide any assistance we can to help manufacturers ensure an adequate supply. Before determining that a shortage is resolved, FDA considers a variety of factors, including the company’s ability to meet current and historical demand, the amount in a manufacturer’s stock, affected market share, ability of alternate manufacturers to cover the demand, and confirmed market stabilization. Please visit FDA’s Drug Shortages Database for the most recent information on the status of GLP-1 medicines and other drugs in shortage.
On first blush, it appeared the “party was over” for those seeking inexpensive compounded tirzepatide.
Semaglutide was still in short supply, and available via compounders at low price. But even that could change quickly.
Then, a lawsuit was filed in Fort Worth, Texas federal court by the Outsourcing Facilities Association claiming the FDA failed to follow proper procedures in making the change.
The FDA did not give the public a chance to weigh in on its decision and trusted assurances from Lilly, “the company that is self-interested in monopolizing the market,” that it could meet projected demand, the lawsuit said.
It called the FDA’s action “arbitrary, capricious and contrary to law.”
Then, the FDA agreed to reconsider its decision; staying the lawsuit.
The agency said in a court filing it would now allow compounding pharmacies and facilities to keep providing the drugs while it reviews whether there is a shortage of their active ingredient. Outsourcing Facilities Association Chairman Lee Rosebush said in a statement the group was “greatly relieved, for our members and the many patients that they serve, that the FDA has agreed to reconsider its decision.”
The Outsourcing Facilities Association claimed in its lawsuit the FDA removed tirzepatide from its shortage list even though it remained in short supply.
Lilly in August began sending cease-and-desist letters to telehealth companies, wellness centers and medical spas selling compounded versions of Zepbound and Mounjaro. The company has also filed lawsuits against sellers falsely claiming to sell FDA-approved versions of the drug.
Is there a shortage of tirzepatide? Dunno. How is current supply/demand calculated? How is projected supply/demand calculated? Given the number of drugs on the shortage list, one would think that there are standard metrics for making such conclusions. But perhaps it’s a judgment call, and there’s flexibility.
So, what’s next?
I think the GLP-1 compounding party will soon be over. But I think other options will open up.
There will be tremendous pressure for the pharmaceutical companies to lower their prices. The drug does not cost much to manufacture, and they can still make their top line revenue numbers, and continue to make a fortune.
New competitors will be coming on line soon, putting more price pressure on established players.
Next carriers will be under pressure. Carriers can also push for price concessions from pharma. Given the health benefits, carriers should be motivated. Because they’re on the hook for costs associated with obesity and diabetes.
There may be options for individual patients to import from Canada or other countries.
And Congress can act. Or can it?
Anyway, the country got used to low cost GLP-1 medications, and given that such medications are intended for chronic use, it’s hard to see how the country will make nice and go back to accepting expensive medications with the supply constrained by limited insurance coverage. The US is a noisy country. And this issue may get a lot more attention than some of the other political issues in the news.
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Should Clinicians Be Liable for Patient Suicide After Failing to Prescribe Pain Medications?
Another person made the following comment on that blog post