A video presentation worth your time to watch

This video was done on Dec 3, 2024 and as typical of me, I was little late to the party, since I just watched it today. You would not believe all the links to some video that can be a ONE HOUR+ that are shared with me.  Unfortunately, I have to pick and chose which ones that I have to carve out the time to watch.

One of the most poignant info was from Attorney Kate Nicholson, who stated that just trying to make change only at the state or federal level, success will be fairly limited. Her statement is toward the end of the video.

When a Pharmacist intentionally throws a intractable chronic pain pt into cold turkey withdrawal

I talked to a practitioner a few days ago, this practitioner had a high intensity, intractable chronic pain pt who had been filling a opiate Rx at a local grocery store pharmacy for some time.  All of a sudden, the pt was informed by a Pharmacist at the pharmacy that he “was not comfortable” to continuing filling the pt’s C-2 and this was just a few days before the pt was get a new C-2 filled. In fact, the practitioner had already electronically sent the C-2 Rx to the pharmacy.

The pt had been taking 135 MME/day for some time. I have often stated that one of the basics of the practice of medicine, the starting, changing, stopping a pt’s therapy. In reality, “I’m not comfortable” is not a valid clinical reason for stopping a pt’s therapy and it would suggest that this Pharmacist is totally indifferent to intentionally throwing this pt into a cold turkey withdrawal and within days of Christmas.

I don’t know if this pt was intending to travel to be with family or the pt was planning on having family at their house for Christmas?

IMO, this Pharmacist should be taken before the state pharmacy board for unprofessional conduct and lack of empathy for the cold turkey withdrawal and torturous level of pain the Pharmacist’s action was intentionally causing for this patient.

I wonder what a State Board Pharmacy actions would  take – if any- against a Pharmacist, if a pt would file a formal complaint?

I went out to www.perplexity.ai and asked the following question:

what could be the consequences to a pharmacist that intentionally cut a legit chronic pain patient off their pain meds and intentionally throws the patient into cold turkey withdrawal. Could the pharmacist be charged with practicing medicine without a license

If a pharmacist intentionally cuts a legitimate chronic pain patient off their pain medications, leading to cold turkey withdrawal, the consequences can be severe and multifaceted. Here are some potential outcomes:

## Professional and Legal Consequences
– The pharmacist could face disciplinary action from their professional licensing board, including the suspension or revocation of their license. This is because such actions would violate the standards of professional practice and potentially harm the patient[1][6][8].

## Criminal Charges
– While the pharmacist would not be charged with practicing medicine without a license, as pharmacists are licensed to dispense medications, they could face other charges. For example, they might be charged with negligence, reckless endangerment, or other crimes related to the harm caused to the patient[5].

## Civil Liability
– The pharmacist and the pharmacy could be held liable in a civil lawsuit for any harm or suffering caused to the patient. This could include damages for physical and emotional distress, medical expenses, and other related costs[5].

## Health Consequences to the Patient
– Abruptly stopping opioid pain medications can lead to serious withdrawal symptoms, uncontrolled pain, psychological distress, and even thoughts of suicide. Patients may also seek other sources of opioids, including illicit substances, which can further exacerbate the situation[1][4][6].

## Ethical and Regulatory Violations
– Such actions would violate FDA guidelines and other regulatory standards that emphasize the importance of gradual tapering of opioid doses to avoid serious harm to patients. This could result in regulatory penalties and further disciplinary action[1][6].

In summary, while the pharmacist would not be charged with practicing medicine without a license, they could face severe professional, legal, and civil consequences for their actions. The primary issue would be the violation of professional standards and the potential harm caused to the patient.

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.davidrankinlaw.com/former-pharmacist-arrested-for-practicing-health-care-without-a-license/
[3] https://www.govinfo.gov/content/pkg/FR-2018-04-30/html/2018-09020.htm
[4] https://www.nbcnews.com/health/health-news/cdcs-new-opioid-guidelines-little-late-chronic-pain-patients-rcna74248
[5] https://www.criminaldefenselawyer.com/resources/practicing-medicine-without-a-license.htm
[6] https://www.npr.org/sections/health-shots/2019/10/10/768914092/dont-force-patients-off-opioids-abruptly-new-guidelines-say-warning-of-severe-ri
[7] https://www.mbc.ca.gov/Download/Publications/pain-guidelines.pdf
[8] https://en.wikipedia.org/wiki/Practicing_without_a_license

Walgreens’ Woes: Retail Pharmacy Giant Reportedly Weighing Private Equity Sale to Sycamore Partners

Walgreens’ Woes: Retail Pharmacy Giant Reportedly Weighing Private Equity Sale to Sycamore Partners

https://www.doximity.com/collections/890523eb-6a52-412a-8533-fb6bbf3abd1b

After a tumultuous run which included making major investments into healthcare delivery assets (most notably VillageMD), Sycamore Partners is reportedly taking Walgreens private as scooped by the Wall Street Journal.

In November, Walgreens parted ways with VillageMD CEO Tim Barry.

It has been a tough few years for the beleaguered retail pharmacy player, and Walgreens has been brought to its knees in 2024. The knockout punch was coming. How did we get here?

Walgreens has been hit hard by uncontrollable secular shifts in consumer behavior. Amazon and others are eating Walgreens’ retail lunch.

The retail side of Walgreens’ business is stagnant and oversaturated with stores, as more consumers shift to online shopping. This challenge is two-pronged. The pharmacy business traditionally operated like a “gas station” model—drawing foot traffic that would lead to retail sales. But as patients increasingly choose online prescription refill services for convenience, fewer people are visiting physical pharmacy stores, resulting in decreased retail shopping at these locations.

So when retail sales sagged, Walgreens needed to make a move in a big way. The big plan involved embarking on an ambitious business transformation journey into healthcare delivery .

This journey jump-started in 2021 with VillageMD as Walgreens cobbled together the below healthcare footprint to sell a healthcare transformation story, including diving into value-based care headfirst.

Execution, however, didn’t go as planned. As Hospitalogists reading this breakdown know, healthcare is hard. Primary care is hard. Value-based care is hard. This dynamic isn’t unique to Walgreens and VillageMD, either.

Unfortunately this assemblage of assets no longer seems to be industry leading.

Plain and simple, Walgreens was desperate and overpaid for what it got in a low-interest rate environment. In its 2024 full year earnings release Walgreens incurred an $8.6B net loss on $12.7B in goodwill impairment charges (meaning they overpaid for these companies and the current earnings/economics could not support the acquired valuation, more or less). VillageMD performance weighed down the healthcare story given acute pressures in Medicare Advantage and changes to risk adjustment, along with significant capital and timeline required to build out an appropriate risk-bearing primary care player.

Unfortunately, unlike CVS, Walgreens lacks some of the most important assets to execute on the strategy (at least so far) to make the flywheel…fly – the PBM and the health insurance plan (side note that CVS isn’t doing particularly well either but for its own reasons).

Despite its own struggles, CVS holds a believable narrative to tell investors. From Q3:

But I digress. This is Walgreens’ share performance since acquiring a majority stake in VillageMD for $5.2B in late 2021, then proceeding to attach Summit Health for $9B in late 2022. At its peak, Walgreens held a $100B+ market cap in 2015.

Today it sits at $8B:

In Walgreens, Sycamore is acquiring a struggling giant, but with a vast revenue base and operating footprint – $147.7B in revenue. While not being an accountant, the impairment charges are largely addressed in 2024, so Sycamore probably thinks there’s significant value to unlock over time as a private company – and tax savings to boot. I’m inclined to agree. Walgreens holds some bright spots. Without being under the gun of quarterly investors Walgreens will have more freedom to reduce its debt load and continue billions of dollars in cost-cutting initiatives (1,200+ store closures in the coming years, capex reductions, working capital reductions). Expect to see Walgreens continue this trajectory but also focus on growing service lines like specialty pharmacy – probably its best acquisition to date.

 

FDA Says Compounded Tirzepatide Must Exit the Market

FDA Says Compounded Tirzepatide Must Exit the Market

Compounders only have 2 to 3 months left to copy injectable

https://www.medpagetoday.com/endocrinology/obesity/113478

The shortage of the diabetes and obesity injectable tirzepatide (Mounjaro, Zepbound) has been resolved, the FDA announced

As a result, compounders will have a grace period of 60 to 90 days to wrap up production and distribution of the combination GIP/GLP-1 receptor agonist during which the FDA won’t take legal action against them, “to avoid unnecessary disruption to patient treatment and to help facilitate an orderly transition,” the agency noted in a letter to maker Eli Lilly

Compounders are only allowed to make copies of a drug when it’s on the FDA shortage list, meaning the demand or projected demand of that drug exceeds the U.S. supply.

First added to the shortage list nearly 2 years ago, the agency initially determined that the tirzepatide shortage was resolved on Oct. 2, prompting it to be removed from the drug shortage list.

But just 5 days later, the FDA was sued by compounders, and as part of a court order, the agency had to reevaluate its decision to remove tirzepatide from the shortage list — a decision that has now been confirmed.

As part of its reevaluation, the agency concluded that the supply is “currently meeting or exceeding demand for these drug products, and that Lilly has developed reserves that it now holds in its finished product inventory, plus significant units of semi-finished product, and has scheduled substantial additional production over the coming months, such that supply will meet or exceed projected demand.”

But even after a shortage is considered resolved, patients and prescribers could still face intermittent localized supply disruptions as products move through the supply chain from the manufacturer and distributors to local pharmacies, the agency noted in their letter.

Furthermore, the 60- to 90-day grace period doesn’t preclude the FDA from taking action for other violations, including in cases of substandard quality or safety concerns.

Approved in 2022 for type 2 diabetes and in 2023 for chronic weight management along with diet and exercise, tirzepatide is the only once-weekly dual GIP/GLP-1 receptor agonist on the market and is arguably the most effective weight-loss injectable

As of today, three other GLP-1 receptor agonists remain on the FDA’s shortage list: semaglutide (Ozempic, Wegovy), dulaglutide (Trulicity), and liraglutide (Victoza, Saxenda). All have been reported as “available” by their respective manufacturers, but the FDA hasn’t formally declared their shortages to be resolved yet.

The agency said it will continue to monitor supply and demand for these products, including tirzepatide.

Biden’s DOJ taking its last swing for the fences

As you read the accusations of the DOJ on CVS, notice the words they use accused of alleges …  dangerous and excessive quantities of opioidstrinity cocktailsespecially dangerous and abused combination of drugs made up of an opioid, a benzodiazepine and a muscle relaxant…. “known ‘pill mills.”…  bearing the hallmarks of abuse and diversion… invalid prescriptions with red flags… what it called CVS’ unlawful practices and to prevent future violations…

THIS IS SUCH BS !!!  Their allegations are nothing but the DOJ doing some statistical number crunching and them “counting” the number of  “statistical out-liars”  as determined by the DOJ or DEA.

There is no mention of a time frame, numbers of prescriptions or any other specific numbers

This year the SCOTUS overturned the Chevron Doctrine which means that federal agencies do not have the statutory authority to create new interpretations of the laws they are in charge of enforcing. In regards to the DEA, think about all the RED FLAGS that they have created during the last 5 decades.

From www.perplexity.ai:

How many prescriptions for opioids/opiates were filled over the last decade

To estimate the number of opioid prescriptions filled over the last decade, we can use data from various sources that track opioid prescribing rates and trends.

National Opioid Prescribing Rates

  • From 2013 to 2015, the annual opioid prescribing rates in the United States decreased from 81.2 prescriptions per 100 persons to 70.6 prescriptions per 100 persons
    1

    .

  • By 2019, the national opioid dispensing rate had further declined to 46.8 opioid prescriptions per 100 persons, and by 2023, it had dropped to 37.5 prescriptions per 100 persons
    6

    .

Total Number of Prescriptions

To calculate the total number of opioid prescriptions, we need the total U.S. population and the prescribing rates per 100 persons.

  • The U.S. population in 2013 was approximately 316 million, and by 2023 it was around 334 million.
  • Using the average population over the decade, we can estimate the total number of prescriptions.

Example Calculation for 2019 and 2023

  • In 2019: With a population of about 328 million and a rate of 46.8 prescriptions per 100 persons, the total number of opioid prescriptions would be:
    328,000,000×46.8100≈15,358,400 prescriptions
  • In 2023: With a population of about 334 million and a rate of 37.5 prescriptions per 100 persons, the total number of opioid prescriptions would be:
    334,000,000×37.5100≈12,525,000 prescriptions

Average Annual Prescriptions Over the Decade

Given the declining trend, we can estimate an average annual number of prescriptions. Here is a rough estimate based on available data points:

  • Average annual prescriptions from 2013 to 2015: Approximately 75-80 prescriptions per 100 persons (midpoint of 77.5)
    1

    .

  • Average annual prescriptions from 2019 to 2023: Approximately 42-46 prescriptions per 100 persons (midpoint of 44)
    6

    .

Using these midpoints and the average U.S. population over the decade (around 326 million), we can estimate:

  • For the period 2013-2015:
    326,000,000×77.5100≈25,295,000 prescriptions per year
  • For the period 2019-2023:
    326,000,000×44100≈14,344,000 prescriptions per year

Total Over the Decade

Assuming a gradual decline from the higher rates in the early part of the decade to the lower rates in the latter part, we can estimate an average annual number of prescriptions. Let’s use a rough average of these two periods:

Average annual prescriptions=25,295,000+14,344,0002≈19,819,500 prescriptions per year

Over a decade (2013-2023), the total number of opioid prescriptions would be:

19,819,500×10≈198,195,000 prescriptions

This is a rough estimate and actual numbers may vary based on more precise data and trends. However, it gives a general idea of the scale of opioid prescriptions filled over the last decade.

Citations:
[1] https://www.cdc.gov/mmwr/volumes/66/wr/mm6626a4.htm
[2] https://www.cvshealth.com/news/pharmacy/cvs-health-fighting-national-opioid-abuse-epidemic-with-enterpri.html
[3] https://jamanetwork.com/journals/jamapediatrics/fullarticle/2781107
[4] https://www.cnn.com/2024/12/18/business/doj-cvs-opioid/index.html
[5] https://www.nature.com/articles/s41598-024-52032-4
[6] https://www.cdc.gov/overdose-prevention/data-research/facts-stats/opioid-dispensing-rate-maps.html

CVS knowingly dispensed ‘massive’ amount of invalid opioid prescriptions: DOJ lawsuit

https://www.newsbreak.com/news/3722553226577-cvs-knowingly-dispensed-massive-amount-of-invalid-opioid-prescriptions-doj-lawsuit

The largest pharmacy chain in America is accused of “unlawfully dispensing massive quantities of opioids and other controlled substances to fuel its own profits at the expense of public health and safety,” according to a civil lawsuit filed by the Justice Department, which was unsealed Wednesday.

The DOJ lawsuit alleges that CVS has, for more than a decade, knowingly filled sometimes-dubious prescriptions for controlled substances that lacked a legitimate medical purpose, or were not valid.

Those prescriptions included “dangerous and excessive quantities of opioids” and “trinity cocktails” — a blend of “especially dangerous and abused combination of drugs made up of an opioid, a benzodiazepine and a muscle relaxant,” the suit stated.

The suit also accuses the company of filling “at least thousands of controlled substance prescriptions” penned by “known ‘pill mills.'”

In a statement to ABC News, CVS spokesperson Amy Thibault called the suit “misguided” and said company officials “strongly disagree with the allegations and false narrative” described in the DOJ suit and will “defend ourselves vigorously.”

DOJ’s lawsuit says CVS “contributed to the opioid crisis, a national public health emergency with devastating effects in the United States.” The suit went on to say: “These included illegitimate prescriptions for extremely high doses and excessive quantities of potent opioids that fed dependence and addiction, as well as illegitimate prescriptions for dangerous combinations of opioids and other drugs.

The suit accuses CVS of ignoring sometimes “egregious red flags” about prescriptions “bearing the hallmarks of abuse and diversion.” The lawsuit points to performance metrics and incentive compensation policies that allegedly pressured pharmacists to “fill prescriptions as quickly as possible, without assessing their legitimacy” and corporate policies that allegedly prioritized speed over safety.

The suit claims CVS refused to implement compliance measures recommended by its own experts to reduce the number of invalid prescriptions with red flags “primarily due to fear that they would slow the speed of prescription filling and increase labor costs,” according to the suit.

The government is seeking civil penalties, injunctive relief and damages to address what it called CVS’ unlawful practices and to prevent future violations.

In her statement, Thibault, the CVS spokesperson, said the company has been an industry leader in fighting opioid misuse.

“Each of the prescriptions in question was for an FDA-approved opioid medication prescribed by a practitioner who the government itself licensed, authorized, and empowered to write controlled-substance prescriptions,” Thibault’s statement said.

She said the DOJ lawsuit “intensifies a serious dilemma for pharmacists, who are simultaneously second-guessed for dispensing too many opioids, and too few.”

 

 

 

 

 

 

 

 

PBM industry TOSS some financial crumbs to pharmacy and ONE national pharmacy associations IS HAPPY

This statement below was out on the web from a VP from one of the NATIONAL PHARMACY ASSOCIATIONS.  This person seem very PROUD that pharmacy can expect an additional FIVE BILLION in profits.

The USA fills 4.9 BILLION prescriptions in 2024. Presume that the PBMs decide what is going to be paid for 90% of them or 4.41 BILLION.  I remember when the PBM industry first showed up on the scene in 1970. The year I graduated from Pharmacy school and got licensed.

Back then 90% of Rxs were brand name meds and today 90% of Rxs are generics. Back in 1970 the average Rx price was in the $4-$5 range, vs today the average Rx is in the $70 range. As a guesstimate, I would say that if it was not for the PBM industry, we are paying at a minimum $30/Rx more because we have all these middlemen involved in our prescription system.

Over the last 5 decades, as the percentage of Rx that the PBMs were controlling went up .. the faster the average Rx prices went up. Multiplying out the number of Rxs the PBM industry control – 4,41 billion by $30/Rx comes out to 132 BILLION/YR.

So it appears that the PBM industry is returning FIVE BILLION. That is just abt 4% of what they are now over-charging and padding their bottom lines. I have to wonder what sort of “song & dance” bureaucrats, politicians and other decision makers were told and they believed that a large number of middlemen coming into ANY SYSTEM.. each with its own overhead costs and desire to show a net profit, could reduce overall expenditures on medication. Again, back in the day, it was claimed that prescriptions were 6% of total medical expenditures and today it is reported that medications are now 12%-15% of total medical expenditures.

Over 45 Million Americans Lack Convenient Access to a Pharmacy

  • Over 46% of U.S. counties are pharmacy deserts. In these counties, more than half of people have to drive more than 15 minutes to reach nearby pharmacies.

  • Today, over 45 million Americans live in a pharmacy desert. That’s an increase of over 9% since 2021, and the rate has outpaced population growth.

  • From 2021 to 2024, the number of community retail pharmacies decreased by nearly 15%, worsening pharmacy access across the U.S.

    Nearly 30% of US drugstores closed in one decade, study shows

  • The study found that more than 29% of the nearly 89,000 retail U.S. pharmacies that operated between 2010 and 2020 had closed by 2021. That amounts to more than 26,000 stores.

Congress has pulled the end of year spending package including long overdue PBM reforms due to unrelated issues. The PBM reforms save $5 billion and represent a lifeline to rural and underserved communities access to their only healthcare provider. Congress should not leave town until these reforms get passed – which are supported by over 100 U.S. House members and 34 U.S. Senators, FTC lawsuits and investigations, multiple congressional oversight hearings, investigations and reports, support from the President-elect, and hundreds of pharmacists’ and patients’ calls, letters, and meetings with congressional staff

Indiana has one of the TOP PHARMACY SCHOOLS IN THE COUNTRY!

There is a total of THREE PHARMACY SCHOOLS IN INDIANA!. Yet especially for the last numerous years, ONLY ONE INDIANA PHARMACY SCHOOL THAT HAS BEEN IN THE TOP TEN PERCENT OF ALL 144  USA Pharmacy Schools  on the percentage of graduates that pass the North American Pharmacist Licensure Examination on FIRST ATTEMPT. I know someone who was in the 1970 Butler Pharmacy School graduating class. That class was also the first class that took the newly created (National) North American Pharmacist Licensure Examination and ONLY ONE OUT OF THAT CLASS THAT DID NOT PASS ON THEIR FIRST ATTEMPT AT TAKING THAT YEAR’S TEST! I felt sorry for my classmate because 1970 was the first draft lottery and he had drew a very low number and the draft board wanted to draft him, but he was trying to get a exemption from the draft until he could take the Indiana boards, which was in Sept and apparently was riding him kind of hard and the stress compromised his him passing his boards.

 

Top 15 pharmacy schools by NAPLEX pass rates

https://www.beckershospitalreview.com/pharmacy/top-15-pharmacy-schools-by-naplex-pass-rates.html

The average all-time pass rate of the North American Pharmacist Licensure Examination was 75.7% in 2023 — a slight increase from the year prior, according to data from the National Association of Boards of Pharmacy. 

In late January, the association released the NAPLEX passing rates for 2023 graduates across 144 schools. Its report compares first-time and all-time pass rates between schools over the last three years. 

In 2021, the first-time pass rate was 81.3%, and subsequent years have dropped to about 77%. For all-time passes, 2021 recorded 77.3%, 2022 saw 73.9% and 2023 saw 75.7%. 

Here are the top 15 pharmacy schools ranked by their all-time NAPLEX pass rates:

Note: The number of attempts in 2023 is included after the percentage.

1. Hampton (Va.) University School of Pharmacy — 100% (4)

2. University of Nebraska Medical Center College of Pharmacy (Omaha) — 97.9% (47)

3. East Tennessee State University Bill Gatton College of Pharmacy (Johnson City) — 95.5% (66)

4. University of Puerto Rico Medical Sciences Campus School of Pharmacy (San Juan) — 95.5% (44)

5. Northeastern University Bouvé College of Health Sciences School of Pharmacy and Pharmaceutical Sciences (Boston) — 93.8% (65)

6. University of Wisconsin-Madison School of Pharmacy — 92.9% (126)

7. Rutgers, the State University of New Jersey Ernest Mario School of Pharmacy (Piscataway) — 92.4% (144)

8. Ohio State University College of Pharmacy (Columbus) — 91.8% (122)

9. University of North Carolina Eshelman School of Pharmacy (Chapel Hill) — 91.6% (143)

10. Butler University College of Pharmacy and Health Sciences (Indianapolis) — 91.1% (101)

11. University of Michigan College of Pharmacy (Ann Arbor) — 90.4% (73)

12. University of Kansas School of Pharmacy (Lawrence) — 90.3% (113)

13. University of Pittsburgh School of Pharmacy — 90.1% (111)

14. Concordia University Wisconsin School of Pharmacy (Mequon) — 90% (50)

15. University of the Pacific Thomas J. Long School of Pharmacy (Stockton, Calif.) — 89.1% (156)

Find the top 20 schools in 2022 by all-time NAPLEX passage rates here.

Be careful on which emails you CLICK ON!

Be careful with any emails that you click on. I have received a RASH of spam/fishing emails. I normally just label them as JUNK and delete them. Last night I got one that would not give me the option of labeling it as JUNK … so I just hit the DELETE KEY on my keyboard and it disappeared….BUT… the shit hit the fan and my laptop lost several programs and/or they would no long work – one was my email prgm.

I even got  a TEXT today on my cell phone wanting me to verify my email that is part of our cable account – that I seldom use. I called the cable company and the text was not from them. I am still trying to put things back together.

Diabetes advocacy group discourages use of compounded GLP-1 drugs

Diabetes advocacy group discourages use of compounded GLP-1 drugs

https://www.biopharmadive.com/news/ada-guidance-compounded-glp-1-drugs-obesity-wegovy-zepbound/734358/

The American Diabetes Association recommended doctors prescribe alternative FDA-approved drugs as Wegovy and Zepbound remain difficult to reliably obtain.

The American Diabetes Association, a high-profile advocacy group, is warning against widespread use of compounded versions of popular weight loss and diabetes drugs like Wegovy and Zepbound.

The group on Monday released an official guidance statement that recommends doctors avoid prescribing unapproved, off-brand versions of the medicines, which have been so in demand their manufacturers, Novo Nordisk and Eli Lilly, have had difficulty keeping up supply.

“We urge health care professionals to consider this guidance statement due to concerns around the safety, quality, and effectiveness of compounded versions of these products,” said Joshua Neumiller, the ADA’s president-elect and a co-author of the statement.

Compounded versions of the drugs may not meet Food and Drug Administration standards for drug content, safety, quality or effectiveness, the ADA said. Compounders have added extra ingredients like vitamins B12 and B6, or have used salt forms of the active prescribing ingredients, leading to dosing errors and adverse events, according to the group.

“We encourage health care professionals and people living with diabetes and obesity to consider this guidance in conjunction with clinical judgment and individual preferences when making informed care decisions,” said Nuha ElSayed, the ADA’s senior vice president for health care improvement, said in a statement.

Wegovy contains semaglutide, a drug ingredient also marketed by Novo as Ozempic for use treating Type 2 diabetes. Similarly, Eli Lilly sells the compound tirzepatide as Mounjaro for diabetes and Zepbound for obesity. Both drugs are also known as incretin therapies or, alternatively, GLP-1 agonists.

They’ve proved powerfully effective at controlling weight and further testing has shown other notable health benefits, such as reducing heart risk for Wegovy and helping control sleep apnea for Zepbound. Demand has soared as a result, leading to periodic short supply over the past two years as Novo and Lilly have struggled to make enough doses.

The shortages have prompted physicians and patients to turn to compounding pharmacies, which make custom preparations of approved products under specific FDA rules permitting their production.

In making the statement, ADA, which includes physicians, health educators and community health workers in its membership, has added a major voice over a dispute that has gripped the FDA and compounding pharmacies over the past few months.

A Court Rejected the Disease Theory of Opioid Addiction. Will We Listen?

There is a “old saying”… when you think that you are a “hammer” everything starts looking like a “NAIL”! Does this also define prominent experts that were able to grant “scientific” credibility who specializes in treating addicts?

A Court Rejected the Disease Theory of Opioid Addiction. Will We Listen?

https://filtermag.org/court-opioid-addiction-disease/amp/

The idea that opioid painkillers are inevitably addictive was put on trial and refuted. But this modern disease theory seemingly can’t be extinguished as long as it is granted “scientific” credibility by prominent experts and unquestioned acceptance by the media.

A 2016 book by Stanford addiction expert Dr. Anna Lembke—Drug Dealer, MD: How Doctors Were Duped, Patients Got Hooked, and Why It’s So Hard to Stop—presented the hard-core, sinister case against drug companies. It’s a case firmly rooted in her view of opioid addiction as an irresistible, irreversible disease.

Meanwhile, the recent, high-profile Hulu series Dopesick is based on the 2018 bestseller by Beth Macy, a journalist who investigated the drug crisis in Appalachia. Macy’s book—Dopesick: Dealers, Doctors and the Drug Company that Addicted America—tells essentially the same story as Lembke’s. The company in question is (or rather, was) Purdue, run by the Sackler family.

The book and series maintain that Purdue/the Sacklers lied that OxyContin was rarely addictive. Instead, people frequently became hooked, and died, because addictiveness is an inherent property of opioids.

Hulu’s Dopesick aims for a feeling of authenticity by, for example, portraying a doctor who had been addicted to OxyContin.

Opponents of the disease model certainly don’t deny that many people become addicted to opioids and other drugs, as well as to powerful non-drug behaviors and experiences. Addiction is fundamental to human experience.

But pointing out the genuine addictive experiences of individuals like Dopesick’s doctor doesn’t shed light on the likelihood of becoming addicted to opioids.

Indeed, we know that likelihood is quite low.

Earlier this month, a court painstakingly ascertained just that, along with dispelling a litany of headline-grabbing claims about opioids 

A Court Rejects Lembke’s Arguments

Unlike Macy and Dopesick’s other producers, Lembke is highly credentialed—a psychiatrist, director of the addiction medicine clinic at Stanford University, and a TED speaker. She is thus deemed qualified to offer expert testimony in court.

On November 1, Judge Peter J. Wilson, in Orange County’s California Superior Court, issued a ruling in a case brought by four California jurisdictions against numerous opioid manufacturers over their alleged liability for causing addiction and many resulting deaths.

His ruling: “There is simply no evidence to show that the rise in prescriptions was not the result of the medically appropriate provision of pain medications to patients in need.”

The court rejected the plaintiffs’ claims, which were based primarily on Lembke’s testimony, finding her and the suing jurisdictions to be plainly wrong in four ways: overstating the incidence of prescription opioid addiction; ignoring the medical benefits of opioid pain relief; generalizing inappropriately from drug death “hot spots” to less severely affected jurisdictions; and failing to show that prescribing practices caused the crisis of opioid-related deaths.

Below are several illustrative quotes taken from an interview with drug manufacturers’ attorneys John Heuston and Moez Kaba, together with excerpts from the judge’s decision.

Hueston: “[The key factor] was Stanford professor Lembke. Dr. Lembke was presented as the lead voice by the plaintiffs for their case trying to establish [drug company] misstatements that drove the crisis in California.”

Kaba: “It’s an extraordinarily methodical order. He [the judge] goes through alleged statement after alleged statement and reaches the findings that these are not false statements …”

“The studies relied upon by Dr. Lembke for that conclusion are inadequate to support it.”

The judge, who regularly stopped the trial to hold detailed discussions about evidence, noted in his ruling that Lembke “testified that one in four patients prescribed opioids would become addicted.”

But, he continued, “as Defendants point out, the studies relied upon by Dr. Lembke for that conclusion are inadequate to support it … the more reliable data would suggest less than 5 percent, rather than 25 percent.” And even with that much lower figure, “addiction based solely on the patient having been prescribed opioids does not occur in ‘most of these patients.’”

Kaba: “One of the things that Dr. Lembke claimed, for example, was that it was false or misleading to suggest that opioids can improve the function of people who take them. And we had her admit very clearly, very plainly, that not just the FDA but the state of California itself in its own laws acknowledges that opioid medications when properly prescribed do, in fact, improve function.”

Defense attorneys were also at pains to contextualize the California jurisdictions’ claims. That is, opioid addiction and death rates are highly dependent on specific locales and social settings.

Defense attorney Hueston: “We certainly wanted to make sure that a case about the opioid epidemic in California actually related to California. And what we wanted to do was to anticipate and blunt the attack from plaintiffs that California is like Appalachia and Tennessee, or some of the other notorious hot spots.”

Kaba: “There’s another part of his order where he says that there’s no causation, which was another big part of our case. In the examination that [Heuston] did of our economist, we proved that there is no causation …”

Proving causation requires linking more prescriptions to greater addiction and death rates. In fact, while there has been a steady decline in painkiller prescriptions, by nearly half, from 2012 to 2020, drug deaths continued to achieve record levels over that period, more than doubling between 2015 and 2020 alone. Causality—if anything—seemingly flows in the opposite direction. That is, restricting painkiller prescriptions leads to negative outcomes.

An Assault on Chronic Pain Patients

The trial additionally highlighted patients’ right to pain relief, and how the disease theory of addiction attacks this right.

Organizations representing pain doctors have strongly objected to draconian limitations imposed on prescribing. The American Medical Association itself has passed “resolutions against the rash of laws and mandatory policies that limit or prevent patient access to opioid painkillers.” Beleaguered pain patients have organized themselves into a grassroots movement.

Heuston: “It was critical to our strategy to ensure that the voices that are in support of proper pain management were heard, that pain management doctors who could help describe the life crises of people who simply have inadequate treatment of pain … the judge’s opinion sets forth not only the understanding of that balance by the FDA and the federal government but how that is enshrined specifically in California in, for instance, the Patients’ Bill of Rights.”

Stanford Medical School and its hospitals, incidentally, subscribe to these rights, including that to opioid medication.

Little wonder that this month, a group representing people with arthritis and rheumatic disease, whose leadership had invited Lembke to present to it, rescinded its invitation: “We understand how some of Dr. Lembke’s previous work and comments can be problematic. Thank you for taking the time and energy to show us articles, interviews, and quotes from Dr. Lembke that are not in keeping with our mission at CreakyJoints.”

Drawing the Wrong Conclusions From Vietnam

The 2020 Netflix series The Pharmacist jumped from a drug-related murder in New Orleans to portray an overwhelming national epidemic of prescription-opioid overdoses due to addiction. This view is put forward in spite of the dominant roles in today’s unprecedented drug-deaths crisis of drug-mixing, of an illicit supply adulterated with fentanyl and its analogues, and of the policies that lead to these conditions. (Due to this toxic combination of factors, it is actually a misnomer to label the deaths simply as “overdoses.”)

Dr. Lembke was interviewed in the Netflix series. “This country has seen two prior opioid epidemics,” she said, citing the Civil War and “when soldiers were coming back from the Vietnam War.”

Most soldiers who used heroin didn’t become addicted, and the overwhelming majority of those who did quickly recovered stateside, without treatment.

But the Vietnam addiction story actually demolishes Lembke’s opioid disease model. As Zach Rhoads and I described in Filter, “Vietnam Vets Proved that Addiction is a Product of Life Circumstances.”

Most soldiers who used heroin didn’t become addicted, and the overwhelming majority of those who did (over 90 percent) quickly recovered stateside, without treatment. The small group whose addictions persisted were identified by their adverse social situations before and after the war.

In 2021, 50 years after Lee Robins’s iconic Vietnam research, science journalist Lauren Aguirre revisited “Lessons learned—and lost—from a Vietnam-era addiction study … It’s too bad this research has been largely forgotten because its lessons can be useful today.”

As Aguirre notes, “many people recover on their own from drug addictions … most of them did not receive formal treatment.”  Furthermore, “exposure to opioids doesn’t inevitably lead to a substance use disorder. Some people can use opioids occasionally without becoming addicted [this included veterans who had been addicted in Vietnam]. In fact, a recent analysis found that only about 3 percent of the tens of millions of people prescribed opioids become addicted.”

In this context, Netflix viewers were led to think that the Vietnam narrative supports Lembke’s (and Dopesick’s) underlying assumption of the inescapability of addiction. But their perspective—which dominates the popular and political discourse—is actually the reverse of the meaning we should have taken from the Vietnam opioid experience.

Media Boosting of the Disease Theory

Media of all kinds and all political stripes are typically stalwart presenters of the Dopesick/Lembke demonization of opioid painkillers. Joe Rogan (who interviewed Lembke*), PBS’s Christine Amanpour (who interviewed Macy), and MSNBC commentators (several of whom interviewed Dopesick producer Danny Strong and showed clips from the series) are just a few examples of the worshipful exposure media give to inaccurate suppositions about opioids.

Hulu promoted a clip from Dopesick in which a tearful Appalachian doctor says that most of his patients became addicted. MSNBC’s Joe Scarborough and Nicolle Wallace, to name two, eagerly endorsed this preposterous claim.

It is our obligation to firmly and finally reject the demonization of drugs—including portraying addiction as the inexorable, irreversible, unavoidable consequence of drug use.

Most media’s ignorance of drug issues has long been a given. More exasperating is when people who support drug policy reform implicitly endorse the disease theory. I recall one event in 2017, at which figures from New York government, public health and several harm reduction organizations celebrated successful efforts to reduce painkiller prescribing since 2012—while simultaneously depicting continually rising drug-related deaths over the same period.

It is our obligation instead to firmly and finally reject the demonization of drugs—including portraying addiction as the inexorable, irreversible, unavoidable consequence of opioid and other drug use.

Many harm reduction and reform advocates rightly focus on the critical role of the social, psychological and economic circumstances faced by people who experience drug-related harms. They understand that drug use is not an infection. It is both a normal behavior and a human response to distress. And they see drug use as a human right, and drug users as a constitutionally protected group.

We will never contain our epidemic of drug deaths until these anti-drug war, anti-disease realizations are more widely shared.