Has these law firms drawn a target on the backs of chronic pain pts?

Amazing that what appears to be the lead law firm in suing the 3 largest drug wholesalers and 3 major chain pharmacies (CVS, Walmart, Walgreen) is claiming that they WON THE WAR ON DRUGS – apparently by causing untold number of chronic pain pts are going to be indiscriminately denied their medically necessary pain medication for their chronic health issues.

I think that it is interesting that the law firm admits that they are using all the media’s routine talking about OD’s involving “fentanyl”, with seldom mentioning that the opioid that people are dying from is an ILLEGAL ANALOG being provided by China & the Mexican cartels, while at the same time the media shows a graphic of the FDA approved Fentanyl and seldom/never do they mentioned that it is actually a POISONING.

Attorney Mike Moore seems to state that these large corporations won’t go bankrupt, but what happens if these major wholesalers and/or major chain pharmacies decide to stop inventorying controlled meds and/or wholesalers only sell control meds to hospitals and nursing home pharmacies. Are these law firms indemnified for any of the consequences to chronic pain pts for not being able to get their medically necessary controlled medications?

We have all seen/read about pts who were cut off from their medications because the DEA raided a practitioner’s office.  Some committed suicide, some have died from cold turkey withdrawal. Some will end up using/abusing NSAID’s, alcohol, Acetaminophen trying to reduce their torturous intensity of pain. Many will end up with liver, kidney damage, heart attack, stroke and eye damage.

The three major drug wholesalers that settled, controls about 80%-85% of all Rx meds to pharmacies. The typical community pharmacy may have up to 30 days of inventory on hand. So if a wholesaler notifies a pharmacies they will no longer be getting controlled meds from their wholesaler.  Within 60 days, most of the pharmacy’s chronic pain pts will be in cold turkey withdrawal.

One can only guess how rapidly the average life expectancy of all these chronic pain pts will decline?

Winning the War on Opioids: A Behind the Scenes Look at The Largest and Most Complex Deal In The History of Jurisprudence

https://pbs.twimg.com/media/F56TEiHW0AABeMC.jpghttps://pbs.twimg.com/media/F56TEiFW4AAU9my.jpghttps://pbs.twimg.com/media/F56TEiFXEAA1fxD.jpghttps://pbs.twimg.com/media/F56TEiGWMAE0g5k.jpg

“Winning the War on Opioids: A Behind the Scenes Look at The Largest and Most Complex Deal In The History of Jurisprudence”
-or
“How US DOJ & Trial Lawyers circumvented public consent to create a work-around ban on rx opioids thru mass tort litigation.”

“A nationwide solution. If you impose serious restrictions in one community, but not the next, offenders simply move their operations. By getting all states & all communities on board, it created a truly nationwide solution to a public health crisis.”

-mass rx restrictions 🤔

“This reform package includes the creation of a groundbreaking clearinghouse through which the Big Three will be required to account not only for their own shipments, but also the shipments of the other distributors, in order to detect, stop, and report suspicious orders.”
“Trial lawyers, processing & organizing almost a billion lines of data tracking every pill from the manufacturer, to the distributor, to the pharmacy. This created the roadmap for the clearinghouse & gave it to every federal, state & local law enforcement officer in the country.”
“a mix of collaboration with highly competent specialists, old-fashioned detective work, big data analysis, and a very innovative legal strategy will help deliver the largest financial proposed settlements in tort history”.
-slow clap, everybody-
specialists like Andrew Kolodny?

“A unique collaboration of law firms led by Florida’s Levin Papantonio Rafferty was at the forefront of the litigation with its large base of city and government clients”

*Papantonio regularly invites govt officials to go sailing on his FL yacht. You know, to talk business.*

“We have always recognized at our firm that walking into massive fights like this is risky and expensive, but we’ve also always recognized that part of our jobs as consumer lawyers is to put it all on the line for American consumers and that’s exactly what we did”.-Papantonio
“And it was all spiraling out of control until this group of private attorneys put the opioid crisis on the front page by filing hundreds of lawsuits against the distributors beginning in early 2017, while the majority of the other lawsuits focused purely on the manufacturers.”

Fine tuning Pharmaceutical Warehouse Monitoring for Optimal Ambient Conditions

Fine tuning Pharmaceutical Warehouse Monitoring for Optimal Ambient Conditions

https://drugstorenews.com/finetuning-pharmaceutical-warehouse-monitoring-optimal-ambient-conditions

With specialty medications now accounting for over half of all drug spending in the U.S., wholesalers and retailers need to ensure the safe and effective delivery of critical, hard-to-get medications to patients who rely on safe, efficient supply chains for their health and well-being. 

Drug Distributor Accreditation, previously known as Verified-Accredited Wholesale Distributors Program (VAWD), from the National Association of Boards of Pharmacy (NABP) is a crucial certification program that ensures pharmaceutical wholesalers and national retailers are following best practices for warehouse holding conditions, protocols for excursions, and corrective action paths. Legacy tools that rely on outdated data loggers, delayed visibility, and spotty Wi-Fi connectivity may help warehousing operations technically meet minimum compliance requirements. However, real-time visibility into different areas of a warehouse’s ambient condition and corresponding alerting is attainable with technology available on the market today that helps operators exceed regulatory compliance requirements and ensure patient safety, inventory freshness, and proactive actions.

With specialty medications now accounting for over half of all drug spending in the U.S., it is especially important for wholesalers and retailers to ensure the safe and effective delivery of critical, hard-to-get medications to patients who rely on safe, efficient supply chains for their health and wellbeing.

Recent Developments with OTC Regulation

Distribution centers that store and transport Over-the-Counter Medicines (OTCs) have always been FDA regulated at some level. However, lately, regulatory bodies have been paying much more attention to OTCs and biosimilars than ever before. State Boards of Pharmacy have significantly increased their vigilance in inspections over the past 2 years because of recent uncoverings that have surfaced from taking a deeper dive into storage conditions, including aspects such as Factory Flooring. Because OTCs are not refrigerated, their governance has been considered less important compared to refrigerated drugs. Monitoring temperature and humidity of storage conditions has always been a CDC suggestion, but not firmly regulated or enforced.

Family Dollar’s recent Advil recall is an illustration of the need for real-time intelligence into the state of pharmaceutical inventories. OTCs becoming too cold or too hot can cause the drugs to become unstable and even degrade, posing a risk of negative side effects and decreasing their effectiveness. 

Warehouse Heatmapping

Warehouses feature shelving and cages that can be segmented into different “zones” within the footprint of the building. Ambient temperature varies between the zones of a warehouse, especially large warehouses that operate with a spoke–hub distribution paradigm. Similar to refrigeration assets, these zones have a certain temperature profile that can be optimized for inventory safety and product quality.

Conducting a thermal heat mapping study is a critical step in ensuring that a pharmaceutical warehouse meets FDA and NABP regulatory requirements. The study involves placement of numerous temporary sensors throughout the warehouse zones to gather temperature and humidity data that reveals the coldest and warmest areas of the warehouse. The data is analyzed, and a report is produced revealing the Mean Kinetic Temperature (MKT) for each zone, informing the placement of permanent sensing capabilities throughout the facility. Studies must be completed in both summer and winter of the same calendar year to account for differences in temperature throughout seasons. Regulations require these studies to be done once every three years for accreditation to remain current.

Mean Kinetic Temperature

MKT measures temperatures fluctuations in a way that provides a more useful picture of asset conditions over time. MKT smoothes out the outlier extremes and provides a sophisticated average that gives operators a clearer idea of product safety during storage. Let’s say the temperature threshold is 77 degrees Fahrenheit, and the product temperature rises to 82 degrees Fahrenheit for five minutes but then comes back down to the acceptable range. The product doesn’t necessarily need to be disposed of or destroyed because operators who have access to the MKT have the context of the products’ stability and the effects of any degradation during excursion are factored in. Use of MKT is critical for monitoring ambient temperature and relative humidity.

The contextual nature of MKT helps operators optimize their warehouse with insights and actions concerning where to store different types of inventories. Based on zone behavior, dry foods, medications, vaccines, and other pharmaceuticals should be placed in different shelving units or cages throughout the warehouse to ensure maximum product quality and safety. Adjustments to the HVAC system and energy consumption can be informed with intelligence gathered from the sensing capabilities, optimizing storage and creating ease and confidence for operators and facilities management. Implementing these strategies is crucial, and seeking the expertise of a good company like hvac repair gresham or enhances the overall efficiency of your heating, ventilation, and air conditioning systems. The MKT process also accurately generates an output of the locations to place NIST compliance sensors to check the extreme temperatures in the warehouse and preserve quality and compliance.

Cross Docking

In a cross-docking operation, products are transferred directly from incoming shipping vehicles to outbound vehicles with minimal storage time during transfer. Certain facilities or warehouses are designed specifically for the practice of cross docking. As a logistics strategy, the intent of cross docking is to speed up delivery times while minimizing warehousing and handling costs. Goods arriving at a cross-dock have a pre-assigned destination and are un-packaged then re-packaged with blister cards – Andex, and organized accordingly allowing seamless movement through the supply chain. Successful cross-dock operations build efficiency and cost-savings into the delivery process.

For cross-docking applications, storage conditions are not the main concern since storage is not the intended activity. However, heat mapping and MKT tracking are still essential functions to optimize the path of products in transit. Especially warm or cold areas of a cross-docking facility need to be accounted for to avoid the damage of crucial inventory, especially in the case of pharmaceutical transfer when specialty medications and critical vaccines are involved.

Internet of Things (IoT) Opportunities 

When maintaining the quality of inventory is critically important, the data that operators use to base their decisions and adjustments upon must be accurate. Traditional sensing capabilities used in pharmaceutical warehouses typically have a manual component to their data transfer process, causing delays in visibility into conditions that may be actively changing. The sensing capabilities of modern IoT infrastructure alleviates the issues associated with conventional processes, providing real-time visibility into ambient conditions, increased accuracy and reliability in data collection, and even prescriptive insights that highlight opportunities for warehousing optimization. For pharmaceutical manufacturers, logistics providers, and retailers alike the opportunities to mitigate unnecessary risk and reduce product loss with modern sensing capabilities are extensive and cost-effective, all while easing the compliance process and building increased patient safety measures into operations.

Reducing opioid use one ambulance ride at a time

Reducing opioid use one ambulance ride at a time

https://oilcity.news/community/health/2023/09/13/reducing-opioid-use-one-ambulance-ride-at-a-time/

Data show a 28% drop in opioid administrations following an alternative pain treatment training for Laramie County first responders.

In what is possibly a first-of-its-kind approach in the country, Laramie County emergency medical services have undertaken training to reduce the administration of opioids — and the results are encouraging.

“We just analyzed our one year data for that, and we actually had a 28% decrease in opioid administration without any change in patient satisfaction or patient pain control,” said Angela Vaughn, a community health project director through Cheyenne Regional Medical Center.

The reduction in opioid prescriptions is important because experts have identified overprescriptions as one of the key drivers of opioid addiction in the U.S.  

In the years leading up to the training, an average of 32% Cheyenne Fire and Rescue patients received non-opioid pain treatments, according to Vaughn. After specialty training and a one year trial period that ended in June, that grew to about 60%.

“This is the first [project] of its kind that we know of where we have completely redone all of the pain protocols, switched up all of the medications and done these really heavy workshops with [over 100 members of] our EMS,” she said.

More data are expected to come from the ambulance service AMR, she said. 

Opioids in an emergency

This latest push for opioid alternatives started in the emergency room. 

Following similar efforts in Colorado, Cheyenne Regional Medical Center’s ER started to follow an Alternative to Opioid — or ALTO — program, but Vaughn said the initial results weren’t as significant as she hoped. 

That could be in part because the effort started during the height of the COVID-19 pandemic — a tumultuous time to introduce new protocols — but also because EMS had yet to be trained on opioid alternatives. 

“We still saw a 10% decrease in opioid administration within the first six months,” when just ER staff were trained, Vaughn said. “But then when we queried our providers afterwards, their main barrier was that the patients were coming to them with opioids already on board.”

That is, EMS had already administered opioids to some patients before they got to the hospital. 

What makes Laramie County’s program unique is that it goes beyond the ER to train EMS providers. 

As the data now show, that novel idea has had significant effects. 

Firefighting pain

Patients were already becoming wary of opioids a few years ago, said Lt. Brice Jacobson, the EMS coordinator for Cheyenne Fire Rescue.

“They’re so afraid that if they get that first dose, they’re now going to be addicted,” he said. 

Being able to offer alternatives to opioids for those who didn’t want those drugs to begin with, “we actually get them excited. Those patients are pretty happy with that,” Jacobson said. 

Opioid alternatives have historically been fairly limited in the prehospital setting, he said, especially when compared to emergency rooms that can stock more medications. At the same time, he added, they can’t just ignore people’s pain. 

“Pain does have a negative effect on the body, especially with healing,” he said. 

Now, armed with new research and training through ALTO programs, Jacobson said paramedics in his crew have new protocols for using alternatives to opioids, like intravenous Tylenol and Motrin. While there had been concerns about side effects of alternatives like Ketorolac before, new research has found the risks are lower than anticipated with small doses, he said.  

“We just analyzed our one year data for that, and we actually had a 28% decrease in opioid administration without any change in patient satisfaction or patient pain control.”

ANGELA VAUGHN, CHEYENNE REGIONAL MEDICAL CENTER

While there was some provider pushback to the new way of doing things, Jacobson said, EMS members are also better trained at talking to patients and assessing how manageable their pain is without opioid intervention.

“I’m also asking … how much pain can you tolerate?” he said. “ And what we find even with that change, a lot of people are like, ‘it’s tolerable. I don’t need this [pain medication].’”

While opioid administrations went down, satisfaction levels have remained largely unchanged, and even improved for some patients, Jacobson found. 

He cautions that opioids, including fentanyl, are still the best way to relieve pain in certain instances, like in a major car crash.

“If someone’s in a car accident, they’re in so much pain and they’re having so many injuries, that it’s just not going to be easy to manage with our non-opioid alternatives,” he said. “So our fentanyl, morphine, those kinds of things might be a little bit better for them. But even then, in those scenarios, we’re still using things more specific like ketamine, and then we’re supplementing … with opiates.”

This isn’t the first time firefighters have been on the cutting edge of fighting the opioid crisis around Laramie County, Jacobson said. While high doses of ketamine have been under scrutiny since Elija McClain’s death, Jacobson said, his department has been using small doses to replace opioids since 2017.

“What the data and research have found before we even went this route [with the ALTO project] was we can still use things like ketamine at a lower dose to manage pain,” he said. “And we’d seen a huge reduction in opiates, just on that alone.”

For Jacobson, trying to combat the opioid crisis is also about making sure people understand how prevalent and dangerous it is. The stigma around it makes it harder to know how many neighbors or friends either have or are in recovery from an opioid use disorder, he said. 

“[An opioid use disorder] affects everyone equally,” he said. “There’s no prejudice, it doesn’t care who you are. It affects everyone.”

 

No ‘Silver Bullet’ for Generic Drug Shortage, House Members Told

No ‘Silver Bullet’ for Generic Drug Shortage, House Members Told

A total of 301 drugs were in active shortage last year

https://www.medpagetoday.com/publichealthpolicy/healthpolicy/106345

From the beginning of Thursday’s House hearingopens in a new tab or window on ways to solve the generic drug shortage, it appeared obvious that little agreement was going to be reached on the best solutions to the problem.

“After months of pleading by the Democratic members of this subcommittee, we’re finally having a legislative hearing on drug shortages in our country,” Rep. Anna Eshoo (D-Calif.), ranking member of the House Energy & Commerce Health Subcommittee, said in her opening statement. “I’ve been frustrated by our subcommittee’s inaction through the spring and summer as I heard from so many physicians in my congressional district, and read about cancer patients, especially children, left behind due to shortages in life-saving treatments.”

Eshoo was especially critical of a “discussion draft” of legislation known as the Stop Drug Shortages Actopens in a new tab or window sponsored by Rep. Cathy McMorris Rodgers (R-Wash.), chair of the full Energy & Commerce Committee. “This proposal mostly studies the problem with more reports,” she said. “Where the proposal has actionable policy, I think it’s a grab bag of talking points … The [bill’s] proposed inflation rebate policy misunderstands the market failure that caused drug shortages.”

McMorris Rodgers defended the bill. “The discussion draft focuses primarily on generic, sterile, and injectable drugs for a serious disease or condition and getting these drugs out from under mandatory 340B [drug discount program] rebates and inflation penalties,” she said, referring to the 340B drug discount program for hospitals that serve a large proportion of uninsured and underinsured patients. “We require CMS to launch a model that tests market-based pricing policies for these drugs in Medicare as well. The discussion draft also looks into how we can bring transparency to current contracting practices through new 340B guidance and disclosure reporting for group purchasing organizations.”

Subcommittee chair Brett Guthrie (R-Ky.) summarized the extent of the problem. “In 2022 alone, there were 301 drugs in active shortage, according to the University of Utah,” he said. “For over a decade, professionals in the medical and regulatory community have sounded the alarm on the underlying economic causes of drug shortages.”

“Unforeseen circumstances like a tornado hitting a pharmaceutical warehouse in North Carolina, or a manufacturing facility in India shutting down due to quality concerns, can throw a supply chain out of whack and potentially cause a shortage of vital drugs,” he continued. “To ensure we’re prepared to respond appropriately to these issues, we must encourage strong investments to ensure that there are multiple means to develop, store, and distribute drugs.”

Rep. Frank Pallone (D-N.J.), ranking member of the full Energy & Commerce Committee, stressed the need for immediate action. “Experts, including doctors providing care on the front line, told us drug shortages are an ongoing emergency for their patients and a threat to national security,” he said. “Patients and providers are facing life-altering consequences if we don’t do more to address this critical problem.”

In addition to McMorris Rodgers’s bill, the committee was considering several other bills to address the problem, including:

  • The Drug Shortage Prevention Act, which would require manufacturers to notify the FDA of a permanent discontinuance or interruption in the manufacture of an excipient (inactive) ingredient or active pharmaceutical ingredient (API) that is likely to result in meaningful disruption in supply. The bill would require the FDA to issue guidance on such notifications no later than 6 months after the enactment of the bill.
  • The Ensuring Access to Lifesaving Drugs Act, which would require manufacturers of life-saving drugs to submit expiration and stability testing studies and make labeling changes accordingly; the measure aims to allow manufacturers to extend expiration dates for drugs if it can be done safely.
  • The Patient Access to Urgent-Use Pharmacy Compounding Act, which would allow certain facilities to compound drugs when a licensed prescriber certifies to the pharmacist that such prescriber has made reasonable attempts to obtain, but has not been able to obtain, a drug to address an urgent medical need.

Melissa Barber, PhD, postdoctoral fellow at the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, explained what is generally known about the shortage issue. “First, some types of products, particularly generic style injectables, are in short supply more often than others,” she said. “Second, while any shortage is important to patients, not all shortages are equal in terms of public health importance. Third, we know that markets for some products are highly concentrated. [A] 2023 study found that approximately one-third of generic APIs produced for use in U.S. markets were manufactured by a single facility.”

However, much is not known, she continued. “First, we don’t even know the cause of most shortages that are reported. As of June 2023, 59% of reported shortages in the FDA’s database did not have a declared cause because manufacturers are not obligated to give detailed information, nor does the FDA audit data to ensure accuracy … Second, we don’t know how many manufacturers there are globally for a given drug, where they are, or how much manufacturing capacity they have.”

While there is “no single silver bullet” to fix the problem, “as a first step, the Agency Drug Shortages Task Force previously launched by the FDA should be reconvened as a single point of responsibility,” Barber said. “At the very least, federal agencies can coordinate efforts.”

If the problem isn’t solved soon, the entire generic industry is at risk, said David Gaugh, RPh, interim president and CEO of the Association for Accessible Medicines, which represents generic drug manufacturers. “Unless Congress acts to address these issues today, business practices by middlemen such as group purchasing organizations, wholesalers, pharmacy benefit managers, and health plans are disrupting the economic sustainability of generic manufacturing, shrinking product portfolios, and reducing the availability of resources to counter drug shortages,” he said, noting that nine out of every 10 prescriptions are for generic drugs.

Gaugh recommended that Congress take several steps to mitigate the problem, including exempting low-cost generics from the 340B program and ensuring that Medicare drug plans cover and encourage the use of new generics and biosimilars.

Urgent notice: Bivalent mRNA COVID-19 vaccines are no longer authorized

Urgent notice: Bivalent mRNA COVID-19 vaccines are no longer authorized

https://ncpa.org/newsroom/qam/2023/09/13/urgent-notice-bivalent-mrna-covid-19-vaccines-are-no-longer-authorized

The FDA has authorized updated COVID-19 mRNA vaccines for 2023-2024. Pharmacies that have been offering bivalent mRNA COVID-19 vaccines should immediately cease administering these products due to FDA withdrawing authorization. More information is available on the FDA website. When submitting claims for dates of service prior to the withdrawal, double check the submitted date. Note that FDA has not yet authorized or approved an updated Novavax vaccine for 2023-2024. As a result, the existing Novavax vaccine may still be administered at this time if it is determined that the individual should not wait for a 2023-2024 Novavax COVID-19 vaccine.

Interesting video about docs & pts and our healthcare system

 


I think that the imagery of these doctors shedding their white lab coats… suggests that all these doctors are being DEFROCKED!

AMERICAN MEDICAL ASSOCIATION (AMA) MUST STOP DEA’s and DOJ’s CRIMINALIZATION OF MEDICINE

Jesse M. Ehrenfeld, M.D., M.P.H., an anesthesiologist from Wisconsin, was sworn in today as the 178th president of the American Medical Association (AMA), the nation’s premier physician organization. Dr. Ehrenfeld said in prepared remarks. “At a time when so many aspects of society have become dangerously polarized, we have seen the proliferation of medical disinformation, junk science, the criminalization of medical care, and a growing distrust in medical institutions and experts.

TO DR. JESSE EHRENFELD, MD, MEDICINE CAN NOT MOVE FORWARD UNTIL THE CRIMINALIZATION OF MEDICINE BASED ON JUNK SCIENCE IN DATA ANALYTICS HAS BEEN ADDRESSED

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

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

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

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.

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