“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
Those with chronic painful conditions have a real reason to celebrate this holiday season! Last week two courts discredited widely accepted propaganda regarding opioid medications. One California and another Oklahoma Supreme Court judge illustrated how misleading this widely accepted and heavily promoted propaganda really is.
Both of these court decisions recognize that under-treatment of pain is a serious public health issue and that medicinal use of prescription opioids rarely led to addiction.
Oh but wait? Didn’t Andrew Kolodny and Anna Lembke (along with thousands of other advocates, politicians, and leading stakeholders), use this propaganda in order to promote their own agendas both nationally and internationally?
For years, special interest groups spent millions (if not billions) of dollars advancing propaganda. They would claim; organizations working to educate the public that opioid addiction was not a common outcome for patients who take it as prescribed were just “Pharma front groups” that needed to be “taken out” at all costs.
These special interest groups spent years marketing the idea that citizens should not receive opioid medications, as a mere exposure would lead to addiction and substance use disorder. They created slideshow presentations that they would use to discredit existing research; using statements not founded in the truth. These statements, in-fact, went directly against the evidence-base.
They successfully lobbied for hundreds of regulatory and legal changes restricting medical access to pain medications. They provided false testimony. Most recently, Ms. Lembke testified that over 25% of patients who use opioids medicinally become addicted; however, the judge corrected her and stated, “it was more like less than 5%.”
So why was her testimony not discredited entirely? Why was she not charged with perjury? These cases are worth billions of dollars and Ms. Lembke provided known false facts in an attempt to sway the outcome of the case. We cannot overlook these serious acts of corruption.
In fact, Dr. Nora Volkow, Director of the National Institute of Drug Abuse, noted in a 2016 review that, “addiction occurs in only a small percentage of persons who are exposed to opioids – even among those with preexisting vulnerabilities”.
So, the stakeholders have known since at least 2016 that patients who use opioid medications were not abusing their supply. Yet, the CDC proceeded with the issuance of their “Opioid Prescribing Guidelines” that same year; resulting in the mass-forced tapering of millions of private citizens. Many of whom have committed suicide since.
Now that this dangerous propaganda is verified to be just that (dangerous propaganda), what will happen next? Will our lawmakers do the right thing? Will they change course in their public-health strategy to address illicit drug use and addiction in America?
It is time our nation came to terms with the facts. We have pursued a failed public-health initiative for well over a decade. This is largely due to our nations’ leaders relying on inaccurate false data and propaganda. Propaganda that was created, marketed, and promoted by the very organizations that partnered with our lawmakers to assist in solving these very issues.
Moving forward, we as a nation must come together and create solutions that work for all patients. The continual use of propaganda is unacceptable and not working. This court ruling brings hope for the future that the truth is now coming forth. It is in the truth that we, as a nation, will find solutions that benefit all.
Remember, Together We Are #CIAAGStrong!!!
Thank you,
Lauren L. Deluca, CPCU, API, AINS
Founding President & Executive Director
Chronic Illness Advocacy & Awareness Group dba CIAAG
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I don’t normally go out on the “political limb”, but long story short – we had video security cameras installed on the house and the “software installer” was here Wed to finish up that part of the installation… right after he left… my hold internet network CRASHED… Only way to get it back up was to reset my router… so I have spent most of post turkey meal resetting all the 13 odd internet devices in my house.. – including 3 TV’s. In trying one of the TV’s.. I made sure that I could stream and just pulled up FOX NATION and pulled up a three part Patriot Purge series…
This proved a very interesting series… very little “talk” by the normal Fox “talking heads”… A fair amount of videos of others within our government and citizens in our country … interacting with our legal system… How it would appear that our military/legal system has no current wars to fight… they are using some of the tactics developed after 911 on many of our citizens that has been labeled as TERRORISTS
Yoho MD, Robert. Butchered by “Healthcare”: What to Do About Doctors, Big Pharma, and Corrupt Government Ruining Your Health and Medical Care (pp. 55-57). Inverness Press. Kindle Edition. The FDA permits data scams. Researchers from the Yale University School of Medicine looked at trials between 2005 and 2012. They found that the FDA based many drug approvals on studies that used various forms of data cheating. Donald Light and Ben Goldacre separately confirmed this story. They wrote: ✪ Thirty-seven percent of the drugs had only a single study. ✪ Forty-five percent of the trials for drug approval used study endpoints such as blood sugar or cholesterol (surrogate markers) rather than hard endpoints such as death or another clinical finding. ✪ Nearly a third 0f all the studies made a comparison with an older drug. When two drugs are found to be about the same, the companies usually claim some obscure advantage for the recent one. This games the approval process and allows the industry to market expensive “me-too” medications that offer no benefit over the older ones. ✪ To make a drug look good, the companies often exclude people who are more likely to have adverse outcomes. Other times, they use people who are more likely to have problems, which can make an older drug look bad. ✪ When companies do nonrandomized trials on unrepresentative populations, they can create almost any result. ✪ Experiments are sometimes run that lack a comparator or control arm. This is called a single-arm trial and has little validity. ✪ Some experimenters do approval studies that are not randomized, controlled, and double blinded, which is the current standard of proof. Some allow studies that are easily unblinded. ✪ To show benefit, sometimes doses of a test drug are used that are too high for routine clinical use. These studies last long enough to show benefits but are kept short enough to conceal adverse reactions. ✪ The other way this is played is to use high doses of the comparison drug. This creates side effects that make the new drug look great by comparison. ✪ Another often-used ploy is inaccurate measurement and improper reporting of the number needed to treat and number needed to harm. ✪ Huge trials are sometimes stopped early because results appear beneficial or harmful at that point. This prevents full evaluation and complete reporting. Physicians should be trained to detect these commonplace forms of deceit when reading medical journals. I spotted them as I learned more. In a 2012 BMJ editorial analysis, Donald Light and Joel Lexchin wrote that, of all the new products developed in the past 50 years, 85-90 percent produced many harms but few benefits. Most of them are me-too drugs used for established markets. They are not improvements. These medications are 80 percent of the US increase in drug spending.
Yoho MD, Robert. Butchered by “Healthcare”: What to Do About Doctors, Big Pharma, and Corrupt Government Ruining Your Health and Medical Care (pp. 55-57). Inverness Press. Kindle Edition.
We know from our own data, that an estimated 70% of the 10 million people, with rare and painful diseases, have had reductions in their pain regimens, without their consent. This is at a rate of approximately 3000 patients per day. The forced reductions are also running at 3000 people per day, without consent. Half of these have been taken off completely, and their lives have been ruined. No one knows the real extent of the problem. In spite of the fact that the Communicable Disease Center (CDC) was required to provide follow-up on the outcomes of the guidelines. It didn’t happen, as it would expose their cruelty and lack of compassion, for the millions with serious and persistent painful diseases. These same people were harmed by declaring that opiate pain medications are dangerous and ineffective, without any justification. The CDC’s proverbial feet will be held to the fire.
The first step in showing the extent of the problem, is the AMA’s offer, to document the number of pain patients harmed by the guidelines. This will allow the patients to briefly tell their pain journey. We are also collecting full stories at the National Pain Council (NPC).
What the AMA wants in the report is just a few simple things:
Name:
(This does not have to be your own name, you can use a surrogate, a nickname and you can also file for others. It is the information they are after, but they might need to reach you or your representative later, if they have questions).
2. City, state and zip code:
(They are not asking for a street address! Your information will be safe. List your real city, state, and zip code. They are going to list the cases by location, and this will be good information for congressional delegates. Remember the golden rule of politics, you must be a constituent).
3. Your diagnosis: (Please list just one or two, your main problems). NPC will provide a means to report more detailed case summaries in the future.
4. Simple summary of difficultly:
Please list any problems you have had getting proper doses of opiate pain medicine, including forced tapers, discontinuations, refusals by pharmacy’s, insurance, emergency rooms, doctors in the hospital, after surgery or whatever the case.
Only list two to three sentences. Remember, if only 10% are reported to the AMA, we would have 300,000 cases. Wait until that hits the press!
5. List the medications you had trouble getting:
If you were just flat-out denied any medication, say “refused all pain medications”, if you were tapered, then list the specific medications: “I was tapered off opiates, benzodiazepines, or my muscle relaxants, whatever.
6. List the Insurance carrier: If involved in any way with insurance denials, prior authorizations that failed, basically any action by that particular insurance company that disrupted your care.
That’s it! It is simple, and won’t take you long. If you have any questions, email us at: nationalpaincouncil@gmail.com and please share and circulate this as widely as possible.
Email your report and any other reports you have assisted with to: opioidtaskforce@ama-assn.org Please send a cc to us at: nationalpaincouncil@gmail.com
If you need help sending it to the AMA, please send a copy of your report to NPC by text, postal service, or carrier pigeon!
National Pain Council LLC 7474 Creedmore Road Suite 317 Raleigh, NC 27613
CVS, Walgreens and Walmart said they would appeal the verdict, arguing it ran contrary to the facts
A federal jury on Tuesday found that pharmacy chain operators CVS Health Corp, Walgreens Boots Alliance Inc and Walmart Inc helped fuel an opioid epidemic in two Ohio counties, in the first trial the companies have faced over the U.S. drug crisis.
Jurors in Cleveland federal court after six days of deliberations concluded that actions by the pharmacy chains helped create a public nuisance that resulted in an oversupply of addictive pain pills and the diversion of those opioids to the black market.
The verdict has the potential to give state and local governments new leverage in their efforts to negotiate settlements that would resolve thousands of other cases against the pharmacy operators.
“The judgment today against Walmart, Walgreens and CVS represents the overdue reckoning for their complicity in creating a public nuisance,” the plaintiffs’ lawyers said in a joint statement.
Jurors only assessed liability. It is up to U.S. District Judge Dan Polster to decide how much the companies owe to abate, or address, the public nuisance in Ohio‘s Lake and Trumbull counties.
The counties’ lawyers have said the costs are potentially $1 billion for each county. A trial on the issue is expected next year.
Stock prices for the companies briefly fell after the verdict but quickly rebounded and were all up less than 1%.
CVS, Walgreens and Walmart said they would appeal the verdict, arguing it ran contrary to the facts and that it misapplied public nuisance law to hold them liable under a novel legal theory that courts in California and Oklahoma have recently rejected in similar cases against drugmakers.
“We will appeal this flawed verdict, which is a reflection of a trial that was engineered to favor the plaintiffs’ attorneys and was riddled with remarkable legal and factual mistakes,” Walmart said.
U.S. officials have said that by 2019 the health crisis led to nearly 500,000 opioid overdose deaths over two decades.
Over 100,000 people died from drug overdoses during the 12-month period ending April 2021, the U.S. Centers for Disease Control and Prevention said in a report last week, a record driven in large part by deaths from opioids like fentanyl.
More than 3,300 opioid lawsuits have been filed nationally against drug manufacturers, distributors and pharmacies, culminating with many of the companies – though not the pharmacies – agreeing to proposed global settlements.
The three largest U.S. distributors that supply pharmacies and hospitals – McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp – and drugmaker Johnson & Johnson in July proposed paying up to $26 billion to settle most of the lawsuits against them.
(Patrick Fallon/Bloomberg via Getty Images / Getty Images)
A bankruptcy judge in September approved a settlement by OxyContin maker Purdue Pharma LP and its wealthy Sackler family owners that the company values at more than $10 billion.
The pharmacies, however, went to trial despite the urging of the judge to settle.
(AP Photo/Seth Wenig / AP Newsroom)
At trial, lawyers for Lake and Trumbull counties argued that the pharmacies failed to ensure opioid prescriptions were valid and allowed excessive quantities of addictive pain pills to flood their communities.
The pharmacy operators denied the allegations. They said they took steps to guard against diversion of pills and blamed others, including doctors, regulators and drug traffickers, for the epidemic.
The verdict followed recent setbacks for plaintiffs pursuing some of the other opioid cases nationally.
Oklahoma’s top court on Nov. 9 overturned a $465 million judgment against J&J, and a California judge this month ruled in favor of four drugmakers in a case brought by several large counties.
Other trials are underway in New York involving drugmakers Teva Pharmaceutical Industries Ltd and AbbVie Inc, and in Washington state with the three distributors.
I recently read an article that mentioned you being an advocate for pain patient rights within the pharmacy and I have a question. I will give you the scenario before asking the question.
My husband is disabled and on pain medication. He fell 2 stories years ago and messed his back up pretty bad. He gets a 28 day supply of a C-II. He prefers to get a 28 day script versus the 30 day. Deer season starts tomorrow and my husband and his family go to our cabin for the week to hunt. My husband isn’t able to walk long distances but sits in a blind by the cabin. I got a text alert from our local Walgreens that some of my husband’s medicines were in the process of being filled. I called to tell them that I would be by to pick everything up the next day because he was leaving on a trip. While I was on the phone, I had asked a female pharmacist if the C-II could be picked up also. She told me yes, that it could be filled the next day even though it was 2 days early. She told me to call the next day because she wouldn’t be there. The next day, I called again and asked them to fill the C-II and I’d be down to get everything. I spoke to a male pharmacist and he said he would have them ready in half hour. Then I get a call from the same male pharmacist and he told me that he couldn’t fill the C-II until 4 days later. I explained that I had already talked to a pharmacist there yesterday and she said it would go through. I knew he was wrong because 4 days would have been 30 days on a 28 day prescription. While I was talking he slammed the phone down and hung up on me. I didn’t understand why he did that because I wasn’t hateful or anything. But I guess he didn’t like me insinuating he was wrong. So I drove down there and he told me that he wasn’t filling them. I asked why and he said they can’t be filled 2 days early. I told him that it’s state law that a narcotic can be filled 2 days early and he got hateful and said he wasn’t doing it because he wasn’t losing his license.
A few things that I have to add. This particular Walgreens has been having problems. They had 2 pharmacists and a tech that walked out and quit. So they’ve had “traveling” pharmacists coming in until they find permanent ones. So my question is, do I have a situation where a complaint is warranted? I planned on calling Walgreens to file a complaint. Also I want to add that my husband always gets his meds on time and never early. But because he was leaving for the week he needed to get them 2 days early.
Thank you
Little wonder this Pharmacist is a “floater” with his customer service demeanor – hanging up on a pt– maybe he considers his PharmD degree was more of a anointment as a PharmDeity . First of all he apparently can’t read that the Rx was for a 28 day supply – NOT THE USUAL 30 DAY SUPPLY – MATH must not be one of his stronger aptitudes. He also apparently doesn’t know or understand the pharmacy practice act in the state he is licensed to practice in… so he apparently make up his own rules/policies. I guess the poor pt should have asked all of his relatives to reschedule their work time so that he could have his medicine so that they could all make a trip/vacation at the same time.
All this Pharmacist – or any Pharmacist – had to do was make a memo/note on the Rx that the pt was going on a holiday/vac trip before the next refill was officially due… Here is a NEWS FLASH… no pt is going to become addicted or OD from a couple of extra days of their medication. Make a pt chose between skipping a trip/vacation with family & friends, trying to cut back on their meds and try to survive the trip or just skip the trip and stay home.. so that you can get your medication(s).
My standard recommendation for pts who end up getting treated like this… to find a independent pharmacy .. here is link to find one my zip codehttps://ncpa.org/pharmacy-locator Where typically you will be dealing with the owner/Pharmacist and they tend to be a lot less judgemental. Take all your meds to them… no pt should be treated like this pt’s wife and any such pharmacy does not deserve a pt’s patronage nor their money.
While I don’t encourage or condone SUICIDE… even before this fabricated opiate epidemic – our country had about 50,000 suicides and ONE MILLION ATTEMPTS per year.. We don’t know how many chronic pain pts have committed suicide and their deaths are declared as a “opiate related death”… because a opiate showed up in their toxicology… and seemingly if it was – or was not – a presumed LETHAL DOSE. The majority of OD’s show 4-7 different substances in their toxicology…
In reading this article, it would seem that there was a lot of BAD DECISIONS in caring for the pt … and being justified with “good intentions”
According to this article, the DEFENSE has asked for the case to be RETRIED… maybe the defense has come with better EXCUSES to defend their actions – BUT – the pt is still DEAD from SUICIDE.
Pt that are forced to live in a TORTUROUS LEVEL OF PAIN… some will end up committing suicide… we can only hope that those pts who are left with few/no choices to put a end to their pain, that their families will take the same path that this pt’s wife/family took. I believe that all too many families walk away from the funeral of a chronic pain pt who has committed suicide or premature death from under/untreated pain …saying ” at least they are now at rest and no longer in pain” and just get on with their lives. They do this … MAYBE … BECAUSE … the chronic pain pt was considered a “liability” or a “albatross” to the family’s dynamics ?
Her husband died by suicide. She sued his pain doctors — a rare challenge over an opioid dose reduction
For six years, Brent Slone had relied on opioid medication to tame his agonizing pain — and then he ran out. He raced to resolve the hang-up over his prescription. He tracked down old medical records, he called his pain clinic repeatedly, he even showed up at the door. But the final word came down: no refills until an appointment almost a week away.
“they denied script im done love you,” Slone, 40, texted his wife on the afternoon of Sept. 12, 2017. He killed himself shortly after.
In an unusual step, his wife then sued the clinic and its physicians — a rare legal challenge to doctors over their decisions to reduce patients’ opioid doses.
Her lawyer argued that Slone was neglected by his doctors and his care mishandled by the pain clinic. Since a car crash paralyzed him from the waist down, Slone had been prescribed high-dose opioids and taken them as instructed. But through his providers’ carelessness, the lawyer contended, his dose was rashly cut by 55%. When he couldn’t get any more medication, he feared days of no relief.
“This is a patient safety, a patient abandonment case,” said the lawyer, Hans Poppe, at the trial, held this August in Louisville, Ky.
The clinic argued Slone’s pain doctors were trying to responsibly treat a patient who was at a precarious moment, one whose suicide was entirely unforeseen. Slone had been placed on “an astronomically high dose” of opioids by other clinicians when he was at a nursing facility recovering from surgery. His pain physicians then lowered his dose to one that he had previously been on. And when he misused that prescription, burning through it too fast, they had no choice but to deny a refill until his appointment. This was standard of care.
“This is a setup for a drug overdose,” Stephen Kyle Young, one of two physicians named in the suit, said about the possibility of authorizing more pills.
The two assertions illuminate a thorny, essential question that has been bubbling into greater awareness: How should doctors safely care for patients who have been on high-dose opioids for years? There’s a push to lower opioid levels amid the country’s addiction crisis, but advocates and experts agree that mismanaged dose reductions — whether too aggressive or too broadly implemented — introduce new, serious harms. Not only can they lead to resurgent pain or withdrawal, advocates say, but they can drive people to seek out illicit opioids or to take their own lives.
Cases like Slone’s are complex, experts told STAT, involving vulnerable patients and high doses of potentially dangerous drugs. But too often, they warned, people who rely on these medications are seeing them taken away under the guise that it will make them safer, when instead it can endanger them.
At the trial, the jury agreed. The panel found the physicians and pain clinic at fault and awarded the family nearly $7 million, with $3 million allocated for Slone’s daughter, who was 12 when her father died.
Researchers stress that attributing suicide to a single cause is difficult. In these situations, patients often have multiple risk factors — including opioid use itself, chronic pain, and accompanying mental health issues.
Still, Slone’s case is notable because it appears to be the first time a jury sided with a patient whose opioid medication was, in their eyes, improperly withheld. It is a sign of the growing recognition that after a reckoning over the damage wrought by prescription opioids, the pendulum swung too far back in certain cases and left another group of people with chronic pain at risk. The message is starting to come from the highest levels, with federal health authorities upping their warnings in recent years about the harms of unsafe dose reductions and stoppages.
“This is the first case that I’ve seen that took that on and said, this is problematic, that endangering people’s health like this is problematic,” said Kate Nicholson, president of the National Pain Advocacy Center.
For CaSonya Richardson-Slone, Brent’s wife, hearing the judge read the jury’s verdict was a moment of relief, one that validated her decision to pursue the case.
“I felt like I had been in fight mode,” she said. “I did it for him, and for my daughter, for everything we’ve gone through, for everything she’s gone through. We had already suffered a lot, through his car accident, but we had adjusted to that new normal. We still had family traditions that were important to us. We still went to dinner and to the movies, and played guitar and did karaoke. We celebrated her birthday, we went to Red Lobster. We still did normal things that families do.”
Richardson-Slone holds a photo of her late husband holding their daughter shortly after she was born. Eve Edelheit for STAT
Before her husband’s death and the subsequent trial, before the car accident that meant her husband would be in pain for the rest of his life, a teenaged CaSonya was a cashier at Winn-Dixie. Brent would go through her checkout line so he could flirt with her, with a boldness that both charmed her and took her aback. They eventually married and had their daughter, settled in Louisville, and spent much of their free time outdoors — hiking, swimming, camping.
Then, in 2011, came the crash. Slone sustained a broken pelvis, a compressed spinal cord, and other injuries that caused chronic pain and put him in a wheelchair. He developed depression. To temper his pain, Slone relied on opioid and non-opioid medications, and in 2014, became a patient at Commonwealth Pain and Spine, which has a network of clinics in Kentucky and Indiana.
Doctors measure opioid dosages in units called morphine milligram equivalents, or MMEs. Federal guidelines now caution against doses above 90 MME a day for chronic pain, or say such doses need to be justified (pain management specialists generally have more latitude). But some patients have been on higher levels for years. Slone’s dose hovered around 240 MME a day, varying depending on his pain levels and procedures.
Slone’s treatment coincided with campaigns to rectify opioid prescribing. To claw back from years of lax dispensing that flooded communities with pills, clinicians started offering smaller doses for shorter periods of time to new patients. As a result, U.S. opioid prescribing has plummeted in the past decade, even as the overdose crisis has reached record heights due to an explosion of illicit fentanyl.
Some experts have also called for clinicians to “taper” the doses of legacy patients to safer levels, to essentially find the lowest dose that can control their pain. It’s not just that the drugs carry some chance of addiction and overdose, but are associated with other risks and side effects as well, including mental health issues. There’s disagreement about whether long-term opioids are even treating pain in many people or they just become physically dependent on the drugs; some evidence indicates that lasting opioid use can worsen pain.
But other experts have pleaded for a more cautious approach for the millions of people living with pain who take opioids — even if they agree that some should never have been placed on such high doses. Many patients are in delicate situations, with disabilities or mental health problems, but seem to have found stability with their medication. Unwise tapering can upend their lives and exacerbate their pain, advocates say. In some cases, physicians, insurers, or pharmacies have suddenly cut patients off. Tapering works for many patients, they say, but it can’t be forced.
It’s a fraught debate, draped by the legacy of profligate prescribing. But despite the divide over how widely to pursue tapering, experts and governmental guidelines agree that — with few exceptions — dose reductions need to go slowly, with patient buy-in.
In 2016, Slone started traveling to California for advanced wound care. His wheelchair caused pressure sores that resulted in bone infections.
He went again in the summer of 2017 for surgeries, including skin grafts, and then recovered for weeks at a nursing facility in La Jolla. His daily opioid intake increased from 240 MME to above 400 MME, occasionally reaching 540 MME. On Aug. 11, he was discharged from the nursing facility at that highest dose for a visit to Kentucky.
Slone’s medical team in California contacted Commonwealth and said that he had enough medication to last through Aug. 16, court records and testimony indicate. Young, the pain management doctor, wrote Slone a “bridge” prescription at that 540 MME level to last until his Aug. 22 appointment at Commonwealth, even as he worried about Slone being on such a massive dose.
Brent and his support dog Courtesy
It was at that appointment that Slone’s dose was dropped by more than half, to 240 MME.
Why such a reduction occurred was disputed at the trial. Poppe pointed to testimony indicating that a nurse inadvertently slashed Slone’s dose to his prior one — perhaps because she copied over information from his chart from months earlier — and that the doctors didn’t catch the error. Poppe argued such a mistake amounted to an unsafe taper, citing guidelines that recommend starting with a roughly 10% dose reduction, and that it demonstrated a failure in patient care.
The defense framed Slone’s reduction as intentional — and suggested the situation was something other than a taper. The higher dose of 540 MME reflected what Slone was on for acute pain following surgery, at a time when he was closely monitored at inpatient facilities. Such a dose would not be safe for him out in the world. They were simply moving him back to his chronic pain baseline dose, and claimed he would not experience withdrawal because 240 MME was still supplying a sufficient opioid amount.
“This is not a taper case,” said James Jackson, the other physician named in the lawsuit. “He was being established back on his safe dose.”
STAT reviewed the issues in the case with outside experts. If the defense’s portrayal of an intentional dose reduction was accurate, the experts still challenged the contention that someone whose prescription was lowered that much couldn’t experience withdrawal — no matter how high the remaining dose was. Responses to opioids are highly variable, but some people get used to elevated doses in as little as a week, they said. The body would expect a certain amount of opioid, and would notice if it wasn’t there, so a return to a baseline dose should happen gradually. Such a rapid reduction could also have allowed Slone’s postoperative pain to return, they said, though they cautioned they hadn’t seen his full medical history.
“This is the problem that we see — there is this rush, almost a panic, to decrease doses rapidly under the guise of patient safety, but the irony is these rapid changes expose patients to greater risk,” said Beth Darnall, a psychologist and director of the Stanford Pain Relief Innovations Lab, who is working on a study examining voluntary opioid tapering.
Whether you call what happened to Slone a taper or prefer another word for the reduction is semantics, they said.
“It was a dose change that people would not be expected to tolerate,” said Stefan Kertesz, a primary care and addiction medicine physician at the University of Alabama at Birmingham’s medical school, who is working on a study examining suicides that occur after dose reductions and stoppages.
On Sept. 11, a few weeks after his dose was dropped, Slone called Commonwealth and reported he was running out of medication, though his prescription was supposed to last another week. At the trial, Poppe acknowledged that Slone misused the medication, taking some 300 to 400 MME per day instead of 240, but contended Slone did so because his dose was cut too fast.
Slone called Commonwealth about a dozen times over the next 24 hours and even went to the clinic to ask about his prescription, according to court records. CaSonya said she called as well and told the staff that Slone was in pain. From Sept. 10 to Sept. 12, Slone also went to emergency departments a number of times — including once after dislocating his hip from falling from his wheelchair — and reported that he was out of medication and was in pain. He was given low levels of painkiller, but was told to speak to his pain specialists to resolve the prescription issue.
“There is this rush, almost a panic, to decrease doses rapidly under the guise of patient safety, but the irony is these rapid changes expose patients to greater risk.”
But Young denied a refill or a bridge prescription ahead of the appointment scheduled for Sept. 18, saying that Slone had violated the narcotic agreement he had signed by taking his medication more often than prescribed.
At the trial, defense attorney Sean Ragland argued that Slone’s suicide could not have been anticipated and that he had not exhibited any signs of suicidal ideation. The greater risk at that moment was overdose, because when Slone went through his medication too quickly, his doctors couldn’t know whether he had obtained an illicit supply or how much opioid he had in his system, the defense contended.
Doctors at Commonwealth “embrace an idea of the conservative approach to opioid use that takes into account each patient’s needs with respect to their pain and also takes into account the risks that opioids present,” Ragland said.
(Following the verdict, the defense requested that the case be retried, but a judge has yet to rule on the motion.)
The experts STAT consulted said situations when a patient goes through a prescription too quickly are challenging — but not uncommon. Pain clinics shouldn’t dole out more pills whenever that happens, especially when someone is on as high of a dose as Slone was, but each case needs to be considered individually, they said. Slone had had a major dose reduction, and he had until then generally complied with his prescription instructions. Given Slone’s tolerance to high doses, the experts also questioned how much of an overdose risk he presented.
“The first thing you should ask is not, [is] this guy is taking advantage of me, but, what broke his consistency this time?” said Michael Barnett, an assistant professor of health policy and management at Harvard’s T.H. Chan School of Public Health, who studies opioid prescribing. (Barnett has served as a paid expert witness for plaintiffs in lawsuits against opioid manufacturers and distributors.)
Steven Stanos, a pain medicine specialist at Swedish health system in Seattle, said pain doctors used to have the instinct not to provide any more medication when patients ran out early. But they’ve realized that by halting the drugs, “you really don’t make the patient safer,” he said. Doctors now try to see patients when that happens, offer a bridge prescription for a low-dose opioid until an appointment can be made, or try buprenorphine, a medication that can ease withdrawal symptoms and address some pain.
“If someone runs out early, the question is, why?” said Stanos, who is on the board of the American Academy of Pain Medicine.
But on the afternoon of Sept. 12, Slone was told he wouldn’t be getting more medication until his appointment, six days away. He killed himself about two hours later.
Richardson-Slone and the legal team after the jury verdict Courtesy
Health authorities are increasingly publicizing the risks of unsafe opioid reductions. In 2019, the Food and Drug Administration warned about the dangers of rapid discontinuation and mandated changes to prescribing information. In September, California’s public health department alerted providers that they should “continue opioid therapy for patients in transition” and “use caution when tapering opioid therapy” when taking on legacy patients.
The Centers for Disease Control and Prevention is also revising its 2016 prescribing guidelines, which were intended as recommendations for primary care physicians treating certain chronic pain patients, but have been used to justify hard caps on doses. Even the guidelines’ authors stress they’ve been misapplied. The updated version is expected next year.
“Some policies and practices citing the guidelines went beyond its recommendations and were inconsistent with its guidance,” the CDC’s Deborah Dowell said at a July meeting. “For example, the guideline does not support abrupt tapering or sudden discontinuation of opioids, but we heard many reports of it being inappropriately cited to justify suddenly cutting off opioids.”
Still, the concerns around opioid dose reductions are taking time to reach all clinicians, said Joanna Starrels, a primary care and addiction medicine physician at Albert Einstein College of Medicine and Montefiore Medical Center. Prescribers for the past decade have been thinking more about the risks and benefits of giving opioids, and now they’re having to consider the risks and benefits of reducing doses as well.
“There is increasing awareness among providers that there are risks of tapering opioids, and we’re beginning to understand those risks,” said Starrels, who focuses on chronic pain management. “Unfortunately, we’re pretty early in that process, both in terms of the research and the evidence to understand who’s at risk for bad outcomes with tapering and when and why … I do think if a provider is not an expert in this field, it’s hard to keep up.”
Brent Slone, and his situation, looks like other patients who have lost access to opioid therapy, experts said — namely that he was a person with disabilities who seemed to fall through the cracks when he transferred between medical teams. But there are important differences. Slone’s issue arose when he had an unusually high dose for acute pain on top of his already high dose for chronic pain. And Slone didn’t experience the abandonment that some patients do, when their physicians stop providing them medication permanently or when their pharmacy or insurer cuts them off.
For CaSonya, who now lives in Florida with her daughter, her hope is that the lawsuit and the verdict help ensure chronic pain patients get the proper care.
She and Brent were separated when he died, but remained close and were figuring out their next steps. What still nags at her about what happened is that they did everything they were supposed to do. They got Commonwealth the medical records from the California facility that the clinic asked for. Brent sought help at the emergency department. When the emergency departments told him he needed to sort this out with his pain physicians, they called Commonwealth repeatedly. It wasn’t enough.
“It was unthinkable that he wouldn’t be seen in their office, or that he wouldn’t get a bridge prescription,” she said. “I never thought I’d lose him in that way.”
Patients may be unpleasantly surprised by a new rule finalized by CMS in July 2020—potentially forcing them to abandon their prescriptions due to unaffordable drug costs.
Sanjeev Seenath, PharmD, MBA, a managed care pharmacy specialist at State of Hawaii MedQUEST division, worries that patients will be even more concerned about their out-of-pocket expenses when they find out that the manufacturers’ copay assistance programs contributions, including copay cards, are being excluded from their out-of-pocket maximums. He said this will cause a ‘trickle down’ effect, resulting in poor patient adherence to medications and negative health effects.
The CMS rule allows commercial health insurers to permit these programs even when a brand name medication does not have a generic or appropriate alternative, while not requiring transparency from insurers about these programs existing, even though it will severely affect their health care spending, according to Bryan S. Walsh, JD, and Aaron S. Kesselheim, MD, JD, MPH, writing in the American Journal of Managed Care August 2021 issue.
“If pharmaceutical companies are able to incentivize their brand-name drug products through their copayment assistance programs, this only fattens their pockets and adds to economic waste in the health care system, which will drive up health plan premiums and health care costs for patients,” said Seenath.
Financial burden on patients
Ever since drug manufacturers started offering copay assistance programs to help cover a portion or the full cost of brand-name medications, patients have been able to afford—for the most part—these medications. However, insurers, both public and private, have lost out on these manufacturer reimbursements which have, up until this point, been automatically applied to their beneficiaries’ out-of-pocket maximums.
With this realization in mind, insurers have put in place copay accumulator adjustment programs (CAAPs) to keep health care costs low by encouraging the use of lower-priced generic alternatives, which in turn places the financial burden on patients.
“The CAAPs program makes it very unfair for patients in cases where there are no generic alternatives available for the patient or in the case where there is a generic drug available, but the brand- name drug appears to be superior due to its therapeutic equivalence,” said Seenath. When manufacturer assistance limits are met, patients will feel the high financial burden of these brand name medications.
Changes in prescribing
“From a CMS standpoint working for the State of Hawaii, discussions about the CAAPs are changing the landscape of how physicians are prescribing drugs because they are concerned about their patients’ health and whether or not they will be able to afford brand name drugs if they aren’t able to take advantage of the manufacturers’ copayment assistance programs,” said Seenath. “This is inadvertently leading to more systemic issues of increased health care costs, higher hospital readmission rates here in the islands, and economic waste.”
Health care providers could be more cautious about prescribing certain medications.
“Clinical outcomes and the quality of care is of utmost importance,” said Seenath. “So, unless there are generic equivalents that are in the same drug class with same therapeutic equivalence and clinical benefit, then the copay adjustment accumulator program is really doing an injustice to the patient and affecting the quality of care.”
To truly help patients, he said, insurance plans need to be transparent with their beneficiaries about these new rules and how it impacts their copayments in order for patients to make well-informed decisions on their health care spending.
This article is a well thought out – well organized – proposed roadmap… it is NOT A QUICK READ !
The path/direction that the war on drugs has been on for 51 YEARS is not going to be changed by a single group or even a handful of groups.. It is either ALL HANDS ON DECK or the raising a “boat load of money” to lobby members of Congress or a dedicated effort to vote out entrenched politicians.
If you don’t think that $$$ don’t influence the member of Congress.. it is reported that collectively… corporations spend NINE + MILLION DOLLARS/DAY to lobby members of Congress to get Congress to pass laws that will favor their company or industry. Companies don’t spend THREE+ BILLION/YR on lobbying Congress if they do not see positive results.
While the DEA & CDC are REPORTING/ADMITTING that 75% of opiate OD’s involved illicit fentanyl – make in China & distributed by Mexican cartels – the DEA is proposing to cut pharma opiate production quotas again in 2022- reduced a total of abt 60% since their peak production in 2011-2012. It is probably just a matter of time before the Mexican cartels start distributing standardized fentanyl tablets. Our various bureaucracies are creating a huge market for the cartels – chronic pain pts who can’t get anyone to prescribe or dispense opiates for their valid medical needs. The Cartels have always been very good in Business 101 – find a need and meet it and you will make money… The chronic pain community – is RIPE FOR THE PICKING – All it will take is a few people to help the cartels to standardize the fentanyl they are getting from China and create standardized strengths of tablets – using the tablet presses that they already have. The rest of this decade could prove to be interesting
