The Whims of Pharmacy Pricing

By Crystal Lindell

I pay cash for my prescriptions every month because I don’t currently have health insurance. 

I got laid off in 2022 and I’ve been freelancing to make ends meet since then, which makes it difficult to get health insurance. I know, not a great situation for a chronically ill patient to be in, but as Gambino said, “This is America.”

Thankfully, the cash prices for my prescriptions aren’t very high, so the situation has been manageable. For my main pain medication, which is not a name brand, I’ve been paying just $36 a month for over two years.

Unfortunately, I recently found out how vulnerable I am to price changes for prescriptions. 

My most recent refill was ready last week, but I was dealing with a pain flare — likely caused by our changing weather here in the Midwest. So I asked my fiance to pick it up for me in an effort to avoid having to endure a taxing trip out of the house.

But while I was at home waiting, he called to tell me that the pharmacy had just told him that there was a new price this month: $86. 

That’s a $50 increase! It literally went up nearly 139 percent! With no warning! 

Doing a little back-of-the-napkin math, because it’s a monthly prescription, that increase results in an extra $600 a year! Not to mention the fact that it also means the price could increase again next month. And then again the month after that. 

So I called the pharmacy to try to figure out what was going on. I spoke to two different people and they both told me that it’s the new price and there’s nothing they can do. 

One of them claimed the price went up months ago, but after I explained to her that I literally got the exact same medication four weeks ago for $36, she changed her story and said the price increased over the weekend. Or it may have increased overnight. 

She insisted there was nothing they could do about it. 

Since it’s a controlled substance and I have a pain patient contract with my doctor, I’m not allowed to have the prescription transferred to a different pharmacy to get it for a cheaper price. It’s one of those opioid regulations that was supposedly launched to keep patients safe, but it has instead resulted in pharmacies having their own monopolies. 

As a freelancer, my bank account balance varies dramatically, depending on which projects I’ve recently been paid for and which ones I’m waiting on payment for. So I didn’t have the full $86 in my account to cover the medication that day. 

Thankfully my mom lives nearby, and I’m able to borrow some money from her when situations like this occur. So my fiance drove home, and then I drove to my mom’s to pick up some cash from her. I then drove to the pharmacy myself to get the medication — all while still dealing with a spike in my daily pain. 

When I got to the counter, I recognized the pharmacist who was working as someone who’s been helpful to me in the past. So I took a chance and said, “Yeah, so the price went up dramatically? Huh?”

She looked at the prescription price and then quietly went to the computer for like 10 minutes to look into it. Then she came back over to me and said, “I got it back down to $36. Here you go, you can pay up front.”

I was half in shock and half worried that if I said the wrong thing, the price would go back up, so I didn’t ask how she did it. I just took the package and went up front to pay, hoping it would still be $36 next month.

I know I should be sharing the details of why it went up and then back down again, but I honestly don’t even know what they are. And I don’t think that those details are necessarily the point. 

The real point is that pharmacies have way too much power in pricing and the entire process is purposely opaque to make it difficult for patients to navigate. After I shared this story with some close friends the day it happened, many of them responded by telling me similar stories about arbitrary pricing at their pharmacies. 

The initial price increase should not have even happened in the first place. What patients pay for medication should not be dependent on the whims of pharmacy staff, especially when patients like me are not allowed to shop around for a more competitive price due to controlled substance regulations. 

As far as I can tell, there are no laws regulating how much pharmacies can increase prices for medication, nor any law requiring them to give a certain amount of notice when they do. If there are laws about such things, they aren’t publicized in any meaningful way. If patients don’t know they have a right, does the right even exist?

I don’t know if there’s any good advice for patients to take from this experience. Most patients on controlled substances can’t risk angering their pharmacist, so it’s understandable they would just choose to pay a higher price if that’s what the pharmacy wanted. 

The situation reminds me of someone else that sells drugs: street dealers. But at least with street dealers, customers usually have the option of shopping around for a better price. 

Muscle Relaxants Ineffective for Low Back Pain and Fibromyalgia

By Pat Anson

Muscle relaxants are increasingly prescribed “off label” as an alternative to opioid medication, but according to a new analysis they are no more effective than a placebo in treating fibromyalgia and low back pain. They may be beneficial, however, for patients suffering from muscle cramps, neck pain and trigeminal neuralgia.

Researchers reviewed 44 studies involving nearly 2,500 patients who were prescribed a muscle relaxant for various pain conditions. Nine skeletal muscle relaxants (SMRs) were assessed, drugs that were initially developed and then approved by the FDA as anti-spasticity and anti-spasmodic medications:

• Carisoprodol (Soma)

• Baclofen

• Tizanidine

• Cyclobenzaprine

• Eperisone

• Quinine

• Orphenadrine

• Chlormezanone

• Methocarbamol

Despite a lack of evidence on their effectiveness beyond 3 weeks, prescribing of SMRs doubled between 2005 and 2016, with office visits for refills of SMR prescriptions tripling over the same period, indicating they were increasingly being used long-term and off-label. According to a 2021 study, over a third of patients prescribed SMRs did not have a musculoskeletal disorder, a sign of “unnecessary or inappropriate use.”

Researchers involved in the current study, published in JAMA Network Open, reached a similar conclusion that muscle relaxants are overprescribed.

“Despite increasing prevalence and increasing risks of their use, our systematic review suggests only limited evidence of efficacy for long-term use of SMRs for a small subset of pain syndromes,” wrote lead author Benjamin Oldfield, MD, an Assistant Clinical Professor of Internal Medicine at Yale School of Medicine.

“Evidence for effectiveness was strongest for SMRs used for muscle spasms, painful cramps, and neck pain; in studies of SMRs for fibromyalgia, low back pain, headaches, and other syndromes, some showed small benefits and some did not, and on balance studies did not suggest a benefit.”

Oldfield and his colleagues say physicians should consider deprescribing SMRs to pain patients who have been using them long-term without apparent benefit.   

Adverse side effects from SMRs include sedation, somnolence, dizziness and dry mouth. The FDA also warns against taking the drugs with opioids, which could raise the risk of respiratory depression and overdose.

SMRs also increase the risk of falls, fractures, and vehicle crashes. Because of those risks, muscle relaxants should be avoided altogether in elderly patients, according to the American Geriatrics Society.

Survey Finds Patients and Doctors Unsatisfied with Treatments for Acute Pain

By Pat Anson

Nine out of ten (89%) patients who recently had short-term acute pain say it caused a major disruption in their lives, limiting their ability to sleep, exercise and enjoy leisure activity, according to a new survey. Many patients also expressed dissatisfaction with the pain medication they received and want to try a new one if their pain returns.

The survey was conducted by Vertex Pharmaceuticals, which is awaiting FDA approval of suzetrigine, its experimental non-opioid medication for acute pain. Vertex surveyed 1,001 adults and 547 doctors who were treated for or who treated acute pain. The company also commissioned a survey by the American Academy of Orthopaedic Surgeons (AAOS), which asked similar questions of 49 of its members who treated patients with moderate-to-severe pain from surgery.

The resulting report, “The State of Pain in America,” is obviously intended to drum up support for suzetrigine by showcasing dissatisfaction with current treatment options for acute pain. But the surveys also provide some interesting insights into what patients and doctors think about opioids and pain care in general.

“The Vertex and AAOS surveys underscore that treating acute pain in today’s health care landscape can be complex, as are the complexities that patients and health care providers have when personalizing pain management, highlighting the unmet need in this therapeutic area for more options,” Vertex said.

About 80 million adults receive treatment for acute pain in the U.S. each year, about half of whom receive an opioid, according to Vertex. Many also take acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) for pain relief.

Nearly a third of patients (31%) said they stopped taking analgesics before their acute pain resolved and 77% said they would be interested in trying a different medication – clear indications of dissatisfaction with their pain care.

Patients were also concerned with how acute pain impacted their lives:

• 70% Limited their ability to walk and exercise

• 69% Limited their sleep

• 65% Limited their hobby or leisure activity

• 65% Made them feel irritable or emotionally drained

• Missed an average of 19 work days annually

The surveys also found that both patients and doctors were worried about the risk of opioid addiction:

• 49% of patients concerned about opioid addiction

• 78% of doctors concerned about patients becoming addicted to opioids

• 88% of doctors believe patients prefer to manage pain without opioids

• 67% of patients said they would request a non-opioid medication in the future

• 52% of patients want a pain medication with fewer side effects

In addition, 83% of providers and 74% of AAOS surgeons said there was a high need for a new class of non-opioid pain medication.

Whether suzetrigine is a solution to these issues is an open question. Unlike opioids, which act on pain receptors in the brain, suzetrigine is designed to block pain in the peripheral nervous system. That means it won’t have the same “liking” effects of opioids or be addictive.

But in clinical studies, suzetrigine was not more effective than a low dose of Vicodin in treating acute pain in patients recovering from minimally invasive surgeries.

The risk of a surgery patient misusing opioids or becoming addicted is actually quite low – less than one percent. One study even found that patients who received no opioids during surgery were more likely to have post-operative pain and require opioids during recovery.

Vertex hopes suzetrigine will be approved by the FDA in January for post-operative acute pain.  The company is also studying the drug as a treatment for pain caused by diabetic peripheral neuropathy and for lumbosacral radiculopathy.  

CDC Is Worried About Shortages of ADHD Stimulants. What About Rx Opioids?

By Pat Anson

The Centers for Disease Control and Prevention is worried that shortages of stimulant medication used to treat attention-deficit hyperactivity disorder (ADHD) may be forcing some patients to turn to street drugs or even suicide.

In a new report, the CDC estimates that 15.5 million U.S. adults have ADHD¸ a condition that causes inattention, impulsiveness and hyperactivity. About a third of those patients were prescribed a stimulant, but 71.5% of them had difficulty getting their prescription filled because of shortages.

“Shortages of stimulant medications in the United States have affected many persons with ADHD who rely on pharmacotherapy to appropriately treat their ADHD,” wrote lead author Brooke Staley, PhD, an epidemiologist at the CDC’s National Center on Birth Defects and Developmental Disabilities.

“Patients experiencing these difficulties might seek medication outside the regulated health care system, increasing their risk for overdose because of the prevalence of counterfeit pills in the illegal drug market, which might contain unexpected substances such as fentanyl.”

This is the second CDC report in recent months to warn about stimulant shortages. In a CDC Health Advisory released in June, the agency said ADHD patients who are unable to obtain Adderall and other stimulants are at risk of “social and emotional impairment, increased risk of drug or alcohol use disorder, unintentional injuries, such as motor vehicle crashes, and suicide.”

The CDC’s concern about ADHD patients is in marked contrast to its ongoing neglect of pain patients, who face similar shortages of opioid medication.

In a recent PNN survey, 90% of pain patients said they experienced delays or problems getting their opioid prescriptions filled at a pharmacy. Desperate for relief, some bought counterfeit medication or other illicit drugs; obtained opioids prescribed to another person; or used alcohol, cannabis and other substances to ease their pain. Nearly a third said they considered suicide because their pain was so severe.

In short, the very same risky behavior that concerns the CDC about ADHD patients.   

We asked the CDC if it was studying the impact of opioid shortages on pain patients and instead got a defense of the ADHD study.

“There has been limited information about (ADHD) diagnosis and treatment in adults and this analysis aimed to fill that information gap – providing the first national estimates on prevalence of adult ADHD in more than a decade. It is also the first national estimates to describe age at diagnosis and treatment, including telehealth and difficulty filling stimulant prescriptions,” a spokesperson said in an email.

It would not be unreasonable to say that the CDC shares some of the blame for chronic shortages of hydrocodone, oxycodone and other prescription opioids. The agency’s controversial 2016 opioid guideline paved the way for steep cuts in opioid prescribing, resulting in “serious harm” to patients who were rapidly tapered and left in uncontrolled pain. Some committed suicide.

The CDC guideline also greased the skids of opioid litigation by exaggerating the risk of opioid addiction and overdose. Faced with a tsunami of lawsuits, drug distributors and pharmacy chains agreed to ration the supply of opioids at individual pharmacies, and drug makers cut back on the production of opioids to avoid further liability. As recently as last month, Teva Pharmaceuticals stopped production of immediate-release fentanyl medicines, potent pain relievers that were relied on by dying cancer patients.

The CDC has been silent about opioid shortages – so have the FDA and DEA.

“We don't make the medicines and we can't tell someone that they must make medicines. There are some things that are out of our control,” FDA Commissioner Robert Califf, MD, said in a 2023 interview. 

Faced with complaints about shortages of ADHD medication, the DEA recently said it would raise the supply of stimulants that drug makers are allowed to produce in 2025, but would continue with its decade-long campaign to reduce the supply of opioids.

That discrepancy hasn’t been lost on pain sufferers.

“You’ve corrected course for ADHD drugs, now do the same for opioid pain analgesics,” one patient posted in a comment on the DEA’s plan. “Do not cut opioids production in 2025. The shortages across the country will be worse, with a corresponding increase in suffering and deaths among chronic pain patients.”

“These proposals will only further the pain and harm on a community of disabled individuals that did not ask to be disabled,” wrote Rebecca Meadows. “Would you want your mother, brother, sister, child or yourself to suffer unnecessarily due to unwarranted cutbacks in pain medications being made? The amount of people who suffer now is ridiculous but it’s only going to get worse if we continue on this path.”

A former CDC epidemiologist wrote a book about how the CDC’s “Disastrous War on Opioids” made the overdose crisis worse. Opioid overdoses have nearly doubled since the 2016 guideline was released.

“There are still significant restrictions on people in chronic pain for no apparent benefit. There continues to be very high rate of overdoses,” said author Charles LeBaron, MD. “I'm kind of a diehard public health guy. I want to see whether anything good happens. Nothing good happened. Time to reconsider.”

New Mothers Lose Custody of Babies After False Positive Drug Tests

By Crystal Lindell

A California mother wasn’t allowed to take her newborn baby home because she ate a Costco salad with poppy seeds and then tested positive for codeine.

A woman in Philadelphia had her baby taken away by child welfare workers after her prescription ADHD medication resulted in a positive drug test for meth. 

A Pennsylvania woman had her newborn taken away by the state for three months because she tested positive for opioids after eating pasta salad.

These are just some of the stories shared in an alarming investigation by The Marshall Project about hospitals giving urine drug tests to new moms — and then reporting them to child welfare agencies when the tests show false positives. 

The Marshall Project interviewed dozens of patients, medical providers, toxicologists and other experts to report the story. They also collected information on over 50 mothers who faced investigations over positive drug tests that were likely wrong. 

At least 27 states require hospitals to alert child welfare agencies if a mother tests positive for an illicit drug, but no state requires hospitals to confirm the test results before reporting them.

While it's unclear how many of the nation’s 3.6 million births every year involve drug testing, healthcare experts told The Marshall Project that urine screening is ubiquitous and “tens of  thousands of infants are reported annually to authorities for in utero drug exposure, with no guarantee that the underlying tests are accurate.”

Many common foods and medications — from antacids and antidepressants to blood pressure and cold medicines — can prompt false results because urine drug tests are often inaccurate.

“People should be concerned,” Dr. Stephen Patrick, a neonatal researcher told The Marshall Project. “This could happen to any one of us.”

A 2001 article in the BMJ makes it clear that, unfortunately, this is not a new problem. The article focused on a U.S. Supreme Court ruling regarding hospitals drug testing new mothers. In a 6 to 3 decision, the court ruled that hospitals cannot drug test pregnant women without their informed consent or a valid warrant if the purpose is to alert the police to a potential crime.

“While the ultimate goal of the programme may well have been to get the women in question into substance abuse treatment and off drugs, the immediate objective of the searches was to generate evidence for law enforcement purposes in order to reach that goal,” the Court said. “It is especially difficult to argue that the program here was designed simply to save lives.”

Although that ruling came down two decades ago, The Marshall Project found that hospitals have gotten around it by using drug screenings to report patients to child welfare services, instead of the police. 

We should call these child welfare interventions what they are: kidnappings. And like any kidnapping, they can cause long-lasting harm to mothers, children and families. 

A 2022 report from Human Rights Watch and the American Civil Liberties Union focused on children who were unjustly removed from a parent's home, often because of the perception by child welfare workers that poverty leads to neglect. 

"Removing a child from their parents, even for a short time, can be highly traumatizing, with long-term consequences," the report found. "In some cases, children in out-of-home placements experience maltreatment, including sexual or physical abuse, causing further trauma."

The Marshall Project found that false-positive drug tests were impacting mothers of all socioeconomic classes and occupations — from a lawyer to a school librarian to a nurse.

There’s a special type of outrage that comes from knowing that hospitals are taking away newborns based on faulty drug tests. But I would argue that the outrage shouldn’t stop there. 

New mothers who actually misuse drugs should not automatically have their babies stolen by the government either. Someone who takes a stray Norco tablet left over from a relative’s past surgery isn’t automatically a bad parent just because they used a prescription drug that wasn’t their own.

The United States has done such a great job spreading “War on Drugs” propaganda that most people just blindly accept the assertion that drug use unequivocally creates an unsafe environment for a baby. Just looking at our evolving cannabis laws shows that past assertions about “Reefer Madness” were not based on any real evidence. 

‘We’re Going to Be Held Liable for That’

One doctor interviewed by The Marshall Project tried to justify the heinous policy of automatically involving child welfare departments after a mother’s positive drug test. He shared a sentiment that many pain patients have heard from doctors and pharmacists about opioid medication.

“God forbid the baby goes home, withdraws and dies, we’re going to be held liable for that,” Dr. Adi Davidov, an obstetrician at Staten Island University Hospital, which drug tests every birthing mother, told The Marshall Project.

"Liable." The word is so telling. As usual, the hypothetical potential for the doctor to face even minor repercussions is the real worry.  

If treating a newborn for opioid withdrawal was really the concern, that could easily be addressed without any involvement from child welfare departments. 

Of course, these policies are also examples of “do as I say, not as I do.” The Marshall Project found that while mothers often lack legal protection from false positives, “most of the caseworkers who investigate them are entitled to confirmation testing and a review if they test positive for drugs on the job."

Allowing for confirmation testing is the type of policy that’s created when the policymakers are concerned about protecting child welfare workers. When it comes to new mothers though, that empathy dies. 

My hope is that the report from The Marshall Project prompts governments and hospitals to re-evaluate their drug testing policies and stop automatically reporting mothers to child welfare agencies. But after watching the War on Drugs up close for over a decade, I’m not optimistic. 

The most effective tactic the War on Drugs uses is convincing people that its harmful policies won’t hurt them. That only bad people use drugs and good people don’t, so you’ll be safe. We’re only after the bad guys.

But the War on Drugs has never been about helping people. Many pain patients have already learned that lesson the hard way, as doctors refuse to give them the opioid medications they need to function. 

But the war is relentless. It never stops. And it’s always seeking new ways to extend its long, dangerous claws into people's lives in unexpected ways. 

As the saying goes, none of us are safe until all of us are safe. Until we drastically reframe our views and policies regarding drug use, we all remain potential victims of the War on Drugs. 

DEA Plans More Cuts in Opioid Supply, While Raising ADHD Stimulant Production

By Pat Anson

The U.S. Drug Enforcement Administration is planning more cuts in the supply of prescription opioids in 2025, while raising production of amphetamine and other stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

If the DEA’s plans are finalized after a public comment period, it would be the ninth consecutive year the opioid supply has been reduced.

Under the Controlled Substances Act, the DEA has broad legal authority to set annual aggregate production quotas (APQs) for drug makers – in effect telling them how much Schedule I and II chemicals and medications they can produce. DEA sets the quotas after consulting with the Food and Drug Administration (FDA) and other federal agencies, as well as individual states about the projected need for controlled substances.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2025 will decline on average 6.6 percent from calendar year 2024 levels. These declines are expected to occur across a variety of schedule II opioids. These declines are expected to occur across a variety of schedule II opioids,” the DEA said in a notice recently published in the Federal Register.

There will not be 6.6% cuts across the board for every opioid. Unlike previous years, the agency is proposing only slight reductions in the supply of fentanyl, oxycodone, hydrocodone and hydromorphone, while keeping quotas unchanged for morphine and codeine.

Most of the cuts are very minor – less than a tenth of one percent -- when the proposed APQ’s for 2025 are compared to the ones adopted in 2024.

DEA Opioid Production Quotas for 2025

• Fentanyl: 0.0025% decrease

• Oxycodone:  0.137% decrease

• Hydrocodone: 0.081% decrease

• Hydromorphone: 0.015% decrease

• Morphine: Unchanged

• Codeine: Unchanged

The DEA notice does not address the discrepancy between the FDA’s estimate of a 6.6% decline in medical need for opioids with the quotas it is proposing. The agency says it considered a “potential increase in demand for certain opioids” due to more elective surgeries being performed in 2025. Many of those surgeries were postponed during the COVID-19 pandemic.

The FDA predicted a 3.5% increase in domestic medical use of Schedule II stimulants in 2025. Demand for stimulants to treat ADHD has grown in recent years, but the drugs are also increasingly used to treat brain fog and fatigue caused by Long Covid. The FDA told DEA it was concerned about ongoing shortages of amphetamine, lisdexamfetamine, and methylphenidate, which are used to make stimulants such as Adderall.    

The DEA wants to raise production quotas for amphetamine (+5.9%) and lisdexamfetamine (+23.5%), while leaving the 2025 quota for methylphenidate the same as it was in 2024. The agency said inventories of amphetamine and methylphenidate-based products had increased, while shortages of lisdexamfetamin continue.

“DEA believes that manufacturers will be able to meet the increase in domestic medical need for these three schedule II stimulants with the APQs proposed in this notice,” the agency said.

The Myth of Opioid Diversion

The DEA has been cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by over 68% and hydrocodone by nearly 73% since 2015. Many of those cuts are due to pressure from Congress, as well as a common belief that prescription opioids are often diverted or sold to people they are not intended for.

That belief is largely a myth.

As required by Congress, DEA estimated the diversion rate of schedule II opioids in 2025, and once again came to the conclusion that diversion is rare – less than half of one percent for oxycodone and hydrocodone. Much of the diversion is a result of theft and losses in the supply chain, before opioids even reach patients.

Estimated 2025 Diversion Rates

• Oxycodone: 0.493%

• Hydrocodone: 0.379%

• Fentanyl:  0.013%

• Hydromorphone: 0.06%

The DEA’s diversion rates are partially based on “red flag” data from prescription drug monitoring programs (PDMP). Potential red flags include patients who see three or more prescribers in a 90-day period; patients who receive a daily opioid dose in excess of 240 morphine milligram equivalents (MME); and patients who pay in cash for a controlled substance.

DEA requested PDMP data from all 50 states, but only 29 states responded to the request by sharing summaries of their red flag data.

“While PDMP data is useful in estimating diversion, it is not conclusive. Further investigation would be required before concluding that any of the subject prescriptions were actually diverted. DEA continues to evaluate its methodologies in estimating diversion in an effort to set quotas more efficiently. State participation is crucial to accurate data analysis, and DEA anticipates working closely with states, as well as other federal and state entities, in future quota determinations,” the agency said.

Public Comments

The DEA quietly published its notice about 2025 production quotas in the Federal Register on September 25, with no fanfare or press release.

Usually the agency receives thousands of comments from the public about its production quotas, but so far there have been only a handful of comments posted. Many are from patients still bitter about the decade of cuts the DEA has imposed on the opioid supply, which have contributed to record shortages of prescription drugs.

“The actions that are being taken by Congress, by the DEA, state legislatures, and state medical boards, have caused THOUSANDS of these patients to lose access to their medications, have resulted in the improper prosecution of pain doctors, resulting in a severe nationwide shortage of pain specialists, and nationwide shortages of medications,” wrote David Smith.  

“The CDC, FDA, and DEA have severely underestimated the needs of chronic pain patients and misjudged the consequences of these cuts. While opioid misuse is a serious issue, penalizing legitimate pain patients is not the solution,” said Gina Harrison.

“Please I'm begging you not to cut opioids meds this year,” said Melissa Guthrie. “I'm on palliative care and there were a couple months last year I didn't get my meds due to shortages. You know it's not the pain meds causing harm. It’s the illicit fentanyl and street drugs killing people.”

You still have time to make your feelings known, as long as you do it by October 25, when the public comment period ends. To make a comment, click here.

Cancer Patients Abandoned When Fentanyl Painkillers Discontinued

By Pat Anson

Patients suffering from severe cancer pain are scrambling to find alternatives after a drug maker discontinued production of potent fentanyl analgesics.

Cephalon, which is owned by Teva Pharmaceuticals, notified the FDA in August that it was stopping production of Transmucosal Immediate-Release Fentanyl Medicines, known as TIRF medications. The FDA then told patients and prescribers that all TIRF meds would be discontinued on September 30.  

“The moment I heard TIRF medicine was being discontinued, I was nearly brought to tears because I fear going back to the way things were before.  I have until the supply runs out and that's it,” said Anthony, a 46-year-old Georgia man who has severe headaches from an inoperable brain tumor. He asked that we not use his last name. 

Anthony has been taking TIRF meds since 2016. He also had a pain pump surgically implanted to deliver opioids around-the-clock, but still needed TIRF for occasional breakthrough pain.

“To transition back to traditional opiates will be a major step back treating my breakthrough pain,” Anthony explained. “Before TIRF medications, I struggled, and my quality of life followed suit.  I spent more time laying horizontal in my bed. It's been a long battle. I'm lucky to still be here.”

TIRF meds are effective because they are absorbed quickly through the mouth and provide pain relief within minutes. The two meds discontinued by Teva are Actiq, a fentanyl lozenge, and Fentora, a fentanyl buccal tablet that dissolves in the mouth.

“Because both of these meds and possibly other forms of TIRF medications bypass the gastrointestinal tract, they are overwhelmingly beneficial in my breakthrough pain,” says Anthony, who is regularly drug tested to make sure he isn’t abusing TIRF.

“I do not get high or feel euphoria.  If I abused these meds that might be an issue, but I take as prescribed.  Plus, if I took more than intended, I would run out of meds before my next refill leaving me without.  Not to mention, I don't want to stop breathing.”   

‘I Think They’re Good Drugs’

Because TIRF medication is made with fentanyl, a synthetic opioid 100 times more potent than morphine, it is poorly understood by the public and often demonized by anti-opioid activists.

Illicit fentanyl is involved in about 70% of fatal overdoses, but prescription fentanyl is rarely diverted and has long played an essential role in treating severe pain. Less than one-tenth of one percent of prescription fentanyl – 0.088% -- is diverted, according to DEA estimates.

“I think breakthrough pain is a horrible thing, and I think these patients really benefit from these breakthrough pain medications,” said Tom Jenkins, PhD, Chief Scientific Officer and Co-Founder of Elysium Therapeutics, which is developing a new class of opioids with less risk of abuse.

“These transmucosal fentanyl drugs are really complementary to the profile of the breakthrough pain and really help patients manage it quite effectively. I think they're good drugs. I don't think they're widely prescribed, so I think the diversion of them is not as significant of a problem.”

Despite that, an op/ed being published in U.S. newspapers refers to TIRF meds as “candy” and “lollipops” – implying they are widely abused and marketed to children, not cancer patients.

“The withdrawal of these potent, short-acting fentanyl products is good news, but they never should have been approved in the first place,” wrote Dr. Adriane Fugh-Berman and Judy Butler, who are affiliated with PharmedOut and Physicians for Responsible Opioid Prescribing (PROP).

“Classified as transmucosal immediate-release fentanyl or TIRF products, these delivery methods are highly potent and highly addictive. The faster an addictive substance enters the bloodstream, the more abuse potential it has. TIRFs acted almost as fast as opioids used intravenously, and addicted many people.”

Fugh-Berman and several other PROP members have collectively been paid several million dollars by plaintiff law firms to be consultants or expert witnesses in opioid litigation, a detail not mentioned in the op/ed or by the news organizations that published it.

Adverse Events

It’s true that TIRF medications have been abused, but many of those cases involved Subsys, an oral fentanyl spray that was illegally marketed by Insys Therapeutics. Insys filed for bankruptcy in 2019, and the company’s founder and several top executives were later convicted of racketeering and bribing doctors.

According to the FDA, adverse events involving TIRF peaked in 2018, with nearly 22,000 reported cases. Since then, they’ve fallen by about 80%.

The decline in adverse events coincided with a steep drop in the number of cancer patients enrolled in the FDA’s Risk Evaluation and Mitigation Strategy (REMS) Program, which facilitated the safer prescribing of TIRF. Over 4,700 patients were enrolled in the TIRF program in 2017. Today there are fewer than 150.

Anthony is one of them.

“The small number of people on the meds are a result of the FDA strengthening the REMS requirements, making it a huge headache for doctors to not only prescribe TIRF meds, but also to keep patients on them, making so much extra work for the doctors,” Anthony told PNN. “Too much red tape involved, so doctors avoid like the plague.”

Another factor is cost. A supply of Actiq or Fentora that might last a few days or weeks for a cancer patient in severe pain will cost thousands of dollars. The drugs are often not covered by insurance.

‘It’s Opioid Phobia’

Why did Teva stop making TIRF medication? The company has not made any public statements about the discontinuation of Actiq and Fentora, and did not reply to PNN requests for comment.

The most likely explanation is that Teva’s bottom line was suffering, due in part to the costs of opioid litigation. In 2008, its Cephalon subsidiary paid a $425 million fine for the off-label marketing of Actiq and two other drugs. Then in 2022, Teva agreed to pay $4.25 billion to settle thousands of opioid liability lawsuits.

Last year, as part of a strategic restructuring, Teva discontinued production of generic oxycodone to focus on more profitable branded drugs.

“It's opioid phobia. I think these companies were spooked by the lawsuits. Maybe some of them did misbehave a little bit and deserved it,” said Elysium’s Jenkins. “I feel for the patients that were using these things appropriately, were getting relief, that are no longer able to access the drug.

“I can only imagine corporate lawyers were just saying, ‘Hey, this isn't worth it. Let's get out of this.’ And also the REMS program. I mean, the FDA is deliberately making it difficult for physicians to prescribe this drug, right?”

Caught in the middle of opioid litigation and a profit-driven healthcare system are cancer patients like Anthony.

“I do not feel the few remaining patients should be made to suffer by discontinuing TIRF medications.  I'm guessing they are doing this because it's no longer as profitable as it once was,” he said. “Why can't small batches be done to maintain the quality of life of the remaining TIRF patients?”

The FDA has shown no interest in keeping the REMS program alive by finding a new TIRF manufacturer. New applications from patients and prescribers are no longer being accepted. And calls to the program’s hotline go unanswered.

“FDA did not request this discontinuation. It is important to note that FDA does not manufacture medicine and cannot require a pharmaceutical company to make a medicine, make more of a medicine, or change the distribution of a medicine,” the agency said in a brief online statement.

Unsecured Opioid Prescriptions and Pet Meds Cause Child Poisonings

By Crystal Lindell

A new study highlights the need for patients and pet owners to make sure their opioid medication is kept secure and away from children. 

The study, published in The Journal of Pediatrics, looked at how young children are often exposed to prescription opioids.  The authors analyzed 230 pediatric opioid poisoning cases that were reported to the New Jersey poison control center over a 5-year period. Most of the exposures were unintentional and involved children under the age of two.

Researchers found that the opioids consumed by children most often belonged to parents (40%), grandparents (17.4%), friends and other family members (7.8%) or were intended for pets (4.3%).

Five incidents involved opioid medication that had been mixed with a food or treat intended for a pet. But when the pet didn’t take it or spit it out, a child found it. 

Dr. Diane Calello, a pediatric emergency physician and one of the study's authors, said it's common for a pet owner to mix medication with food to make it more palatable to their pet.  

“Anybody who has ever tried to give medications to a dog or a cat that doesn’t want to take it knows you put it in peanut butter or cheese,” Calello told WHYY News. “If you give a pet that medication and they walk six, eight feet away and then they spit it out on the ground, there’s that little morsel that happens to contain medicine in it and children can obtain that and put that in their mouth as well.”

As for the medications belonging to grandparents, Calello and her colleagues noted that older patients may not get much counseling on the proper storage of prescription drugs because healthcare providers assume they have no children living with them. 

Most of the child poisonings involved pharmaceutical opioids (86%), occurred in the child’s home (91%), and resulted in the child being admitted to a healthcare facility (84%).

Nearly 9% of the cases involved medication wrappers that were already opened, divided pills and buccal films that were improperly stored, and exposure to opioid residue left on tissue paper, cotton balls, cellophane and analgesic patches.

In some cases children came across used fentanyl patches, illicit drug paraphernalia, liquid opioids or discarded medication left in trash cans and handbags, or left on countertops. 

“People think when they’re handling intact medication in a prescription package, ‘That is something I need to keep safe,’” Calello said. “But you don’t have that same checkpoint in our brain for things that we throw away.”

The researchers recommend that the overdose reversing drug naloxone be prescribed to everyone getting opioids, whether they’re intended for a human or pet. Naloxone can be safely given to children after exposure.

Requiring naloxone prescriptions for patients getting opioids is controversial among pain patients, especially if they have to pay for it themselves out of pocket. 

However, studies like this show why anyone who takes opioids should consider carrying naloxone with them, especially if they are visiting a home with children.

Guideline: Pediatricians Can Prescribe Opioids to Children as Needed

By Pat Anson

Fears about children becoming addicted and overdosing on opioid medication have led to the undertreatment of acute pain in pediatric patients, according to a new clinical guideline by the American Academy of Pediatrics (AAP).

The AAP guideline – the organization’s first to address opioid prescribing to children and adolescents -- urges pediatricians to start with non-opioid medication when treating mild to moderate acute pain. Opioids can be prescribed if a child is in severe pain or doesn’t respond to non-opioid treatment.

“There’s been a big pendulum swing in the practice of medicine over the last two decades—first with opioid-overprescribing, then with a huge cutback in opioid prescribing, likely leaving some children’s pain undertreated,” said lead author Scott Hadland, MD, Chief of Adolescent Medicine at Massachusetts General Hospital and an Associate Professor of Pediatrics at Harvard Medical School

“We want pediatricians to prescribe opioids when they’re needed because untreated pain can lead to distress and psychological harm. At the same time, physicians need to take steps that reduce the long-term risk for addiction.”

The guideline recommends that immediate release opioids be used, starting with a low dose and an initial supply of five days or less. Opioids can be prescribed for longer periods if a child is recovering from trauma or surgery and the pain is expected to last longer than 5 days. Every prescription for opioids should also include a prescription for naloxone, an overdose reversal drug.

The AAP warns that codeine or tramadol should not be prescribed to patients younger than 12 years; adolescents 12 to 18 years of age who have obesity, sleep apnea, or severe lung disease; or when treating surgical pain after a tonsillectomy or adenoidectomy.

“For a patient with mild to moderate pain, doctors should always start nonopioid medications and treatment,” said guideline co-author Rita Agarwal, MD, a Pediatric Anesthesiologist and Professor at Stanford Medicine. “Opioids do remain an important tool for acute pain relief.  But there are times when acetaminophen and ibuprofen may be equally effective with fewer side effects, such as in procedures such as tonsillectomy, wisdom teeth removal, and fractures.”

The AAP’s guideline is based on a review of 11 clinical studies involving pediatric outpatients being treated for acute pain. Hundreds of other studies were excluded from the analysis because they involved adults or hospitalized patients.

The use of opioids by children and adolescents has been a contentious issue for many years. Opioids were once commonly prescribed after wisdom teeth removal, a practice that is now discouraged.

The AAP’s guideline review committee found that most children prescribed opioids do not become addicted or have an overdose. The risk of a child developing opioid use disorder or experiencing an overdose one year after a prescription ranged from 0.3% to 5.8%.

The World Health Organization (WHO) released a guideline in 2021 recommending that opioids only be given to children who are dying or seriously ill and not expected to recover. The WHO guideline found that “evidence of the effectiveness and safety of opioids is completely lacking in children.”  

Sickle Cell Patients Have Even Fewer Choices for Pain Relief

By Crystal Lindell

Pfizer is voluntarily taking its sickle cell disease medication Oxbryta (voxelotor) off the market, amid concerns that it could be causing deaths and other complications. Doctors are being told to stop prescribing Oxybryta and to start sickle cell patients on other medications. 

Pfizer said its decision was based on clinical data showing the overall benefits of Oxbryta no longer outweighs the risks. In postmarketing studies, patients taking Oxbryta had higher rates of a vaso-occlusive crisis, a condition that causes severe pain when mis-shaped red blood cells block the flow of blood to tissues and organs. Patients taking the medication also had higher death rates. 

The company said it was also discontinuing all clinical trials of Oxbryta and expanded access programs worldwide. Oxbryta has been on the market since 2019. The medication works by preventing red blood cells from becoming C-shaped and breaking down too quickly.

Pfizer’s announcement delivers another setback to sickle cell patients, who already lack treatment options and face discrimination in the healthcare system. There aren’t many treatments for sickle cell disease (SCD), a lifelong inherited blood disorder that can cause complications starting in early childhood and lead to shortened life expectancy.

The lack of treatments is due in part to the fact that SCD is relatively rare in wealthier countries. It primarily impacts those whose ancestors are from sub-Saharan Africa, an under-served patient population. About 100,000 Americans have SCD, a number so low it discourages drug makers from developing medications to treat it. Over 8 million people worldwide have SCD.

Many sickle cell patients have also borne the brunt of opioid phobia in the United States. They often end up having to go to the ER during pain flares, where many are treated as drug seekers. 

‘This Is a Step Backward’

The National Alliance of Sickle Cell Centers released a statement saying the Pfizer recall was disappointing. But they were glad that Pfizer was re-evaluating Oxbryta to see which SCD patients may still benefit from it..

"At this time, the risks are too great but there may be an opportunity in the future to better understand how to optimize this medication (and all) medications in sickle cell disease,” the organization said. 

It urged sickle cell patients currently taking Oxbryta to make an appointment with their doctor and emphasized that patients should not stop taking the drug abruptly. Instead, they should work out a weaning plan with their care team. 

“Don’t lose faith,” they said. “This is a step backward but we will stay on the path to better outcomes for everyone.”

The organization added that these types of issues highlight the importance of long-term follow-up with a sickle cell center and of clinical registries like GRNDaD, an international registry developed to track the effectiveness of SCD treatments.

“We encourage everyone to see a sickle cell specialist annually to review what is and what is not working for them,” the organization said. “We all know that sickle cell disease is highly variable, many people are different and respond differently to medications. We need to better understand these differences to identify which medication will work best for which people."

An article in MedScape explained that Pfizer’s decision to recall Oxbryta (voxelotor) came amid increased scrutiny of the drug by the European Medicines Agency (EMA). 

EMA began a review of voxelotor in July after data from a clinical trial showed that a higher number of deaths occurred with the drug than with placebo. Another trial showed a higher  number of deaths than expected. 

Pfizer’s Aida Habtezion, Pfizer’s Chief Medical Officer, said the recall was in the best interest of patients. 

“Our primary concern is for patients who suffer from SCD, which remains a very serious and difficult-to-treat disease with limited treatment options,” Habtezion said. “We advise patients to contact their physicians to discuss alternative treatment while we continue to investigate the findings from our review of the data.”

Patients, physicians, pharmacists, or other healthcare professionals with questions about Oxbryta should contact Pfizer at 1-800-438-1985.

Hurricane Helene Highlights Need for Emergency Prescription Access

By Crystal Lindell

Following the news for Hurricane Helene this week, I’ve been worried about everyone in its path. But it’s the people who rely on prescription pain medication that I am most worried about. 

When natural disasters strike, patients who rely on opioids and other controlled substances can be left to face withdrawal or the black market to fill the gaps until doctors and pharmacies are fully functioning again.

While some states have laws in place to allow people to get early refills of their prescriptions when there’s an impending natural disaster, those laws can specifically exclude controlled substances like hydrocodone and Adderall. 

According to a 2022 article by Healthcare Ready, the laws vary widely state-by-state and are poorly organized. Only 12 states have laws or regulations that allow for emergency prescriptions during a specified public health emergency. About half the states allow for short-term refills of medication during unspecified emergencies. Fifteen states and the District of Columbia don’t have any regulations allowing for emergency prescriptions.

The two states facing the worst from Hurricane Helene, Florida and Georgia, both have laws allowing for emergency prescription refills – but only one allows for refills of opioids. 

Georgia specifically excludes Schedule 2 controlled substances such as codeine, hydrocodone, morphine and amphetamines, according to Atlanta News First. 

Florida’s law is much more expansive. You can obtain a 30-day refill of any prescription medication, as long as your county meets one of the state’s disaster qualifications. 

My guess is that Florida is more lenient due to the state’s reputation as a retirement destination. Older retired people are more likely to need pain medication and more likely to vote. 

It’s understandable that states more commonly hit by hurricanes would have laws in place to address this issue, but every state should allow for emergency prescription refills. Natural disasters like earthquakes, tornadoes and wildfires can happen anywhere. 

Ideally, this would be something best addressed at the federal level, so that patients who have to evacuate their state during emergencies would know they can get refills no matter where they go. Pharmacists would also need to be aware of how to apply the regulations. 

The Food and Drug Administration recommends that patients have at least a week's supply of  medication in case of emergencies – something that’s impossible for many pain patients. You know things are not functioning correctly when a federal agency is giving medical advice that patients are literally unable to follow. 

The last thing anyone facing the threat of losing their home or even their lives should have to worry about is running out of hydrocodone. Even a small daily dose can cause withdrawal if stopped abruptly.

Medication withdrawal in normal conditions can feel like hell. I can’t imagine what it would be like if you also had to deal with the aftermath of a hurricane or wildfire. It could take days or weeks before power is restored, pharmacies to reopen, and supply chains to start functioning again.

Nobody should have to endure that, and with sensible laws in place across the country, nobody would have to. 

Are U.S. Overdose Deaths Really Declining?

By Pat Anson

Preliminary data from the CDC suggest that U.S. overdose deaths have declined significantly, falling by 10% in the last year alone. If confirmed, the double-digit drop would mean there were 11,247 fewer drug deaths in the 12-month period ending in April 2024.

The decline, first reported by NPR, was hailed by addiction and public health experts as a hopeful sign that progress is finally being made in reducing the number of drug deaths, which have doubled in the past decade to over 100,000 a year.

“This is exciting," said Dr. Nora Volkow, director of the National Institute on Drug Abuse. "This looks real. This looks very, very real."

Good news, if it’s true. But caution is warranted about how “real” the decline is, because preliminary death data often changes as more information comes in.

Overdose data is fragmented in both quality and quantity, as it comes from 50 different sources. The data is collected by each state and then submitted to the CDC to decipher for its monthly Provisional Drug Overdose Death Count.

Some states still do not use toxicology tests to confirm whether a death is drug-related – leaving it up to medical examiners and coroners to decide which drugs, if any, may have played a role in someone dying. Some elected coroners, particularly in rural counties, have no medical training or expertise in drug death investigations. And in many cases, autopsies are not performed.

In addition to the wide variability in expertise and data collection, overdoses are typically not reported to the CDC until four months after the date of the death, sometimes longer. In its most recent provisional count, the CDC acknowledged that its overdose data may underestimate the actual number of deaths.

“Some states may have longer than usual delays in submitting drug overdose deaths. In particular, North Carolina is experiencing substantial delays in the resolution of pending records by the medical examiner’s office. Recent trends may underestimate the death count in affected states and this potential impact should be considered when comparing results for states to previous months,” the CDC said.

Percent Change in Drug Overdose Deaths (April 2023 to April 2024)

SOURCE: CDC

Reported vs Predicted

Because the provisional counts are often incomplete and the causes of many deaths are “pending investigation,” the CDC maintains two different data sets. One is the number of “reported” cases, and the other is the “predicted” number of deaths. The latter is where the 10% decline comes from.

The number of reported drug deaths is even lower than the predicted ones, suggesting there has been a 12.2% decline in overdoses nationwide. But that number is also misleading because it is based on incomplete data.

Take North Carolina, for example. For the most recent 12-month period ending in April, North Carolina reported 2,512 drug deaths, compared to 4,317 overdoses from the year before. That’s a whopping decrease of nearly 42 percent!

No one believes that number is real and will hold up over time. Not even Nora Volkow.

North Carolina is not an outlier. Reported drug deaths in Nebraska are down nearly 30 percent, but the data from there is considered “underreported due to incomplete data.” The same is true for Ohio, Pennsylvania and Michigan, where reported drug deaths are down about 20 percent. Big states like that can sway nationwide estimates.

Meanwhile, reported drug deaths are up in several western states: +42% in Alaska, +15% in Oregon, +13% in Nevada, +10% in Washington and +7% in Utah. It’s hard to square those numbers with any national trend.

“Utah’s trends haven’t aligned with national trends for some time. We plateaued while overdoses increased significantly at the national level, especially during the pandemic,” Megan Broekemeier, an overdose research coordinator for the Utah Department of Health and Human Services, told the Deseret News. “We haven’t seen statistically significant changes in the rate yet.”

‘The Dip in Overdoses Is Real’

To be fair, some of the overdose-related data is encouraging and suggest that drug deaths are in fact declining.

In a blog that tracks health data trends, Nabarun Dasgupta, PhD, a drug researcher and scientist at the University of North Carolina, reported a nationwide drop in ER visits and EMS calls (ambulance runs) involving overdoses. He estimates that non-fatal overdoses have fallen -15% to -20% nationwide

“A 15-20% decrease in non-fatal overdose and a 10% decrease in fatal overdose is a major impact. There is barely any public health intervention that has credibly achieved this magnitude of decrease,” wrote Dasgupta. “Our conclusion is that the dip in overdoses is real, and not a data artifact. It remains to be seen how long it will be sustained.”

Dasgupta attributes the decline to several possible factors, such as wider access to the overdose recovery drug naloxone and increased law enforcement seizures of illicit fentanyl.

He does not think the decline in opioid prescribing has anything to do with the drop in overdoses. Deaths linked to opioid pain medication have remained flat for nearly a decade, even as prescribing levels fell to 20-year lows.

“Let's put one hypothesis to rest: Reductions in opioid analgesic prescribing is not driving the changes in overdose rates. We've studied it, and that's not what is driving current fentanyl overdoses,” says Dasgupta.    

The CDC has a checkered history when it comes to tracking overdose deaths. When the agency released its controversial 2016 opioid guideline, it laid the blame for rising overdose deaths squarely on opioid analgesics.

“Overprescribing opioids – largely for chronic pain – is a key driver of America’s drug overdose epidemic,” said then-CDC director Dr. Thomas Frieden, a claim based on weak evidence and false assumptions.

Two years later, after millions of pain patients had their opioid doses reduced or cutoff, the CDC admitted that illicit fentanyl was driving the overdose crisis and that it mistakenly classified many fentanyl deaths as overdoses caused by prescription opioids.The death toll from prescription opioids in 2016 was nearly cut in half — from 32,445 down to 17,087 — when the deaths were reclassified as fentanyl-related.

The CDC says its data collection and analysis have improved in recent years, but they still come with a disclaimer that the monthly provisional counts “may not include all deaths that occurred” and are “subject to change.”

"I think we have to be careful when we get optimistic and see a slight drop in overdose deaths," said Dan Salter, Director of the North Carolina Office of National Drug Control Policy, told NPR. "The last thing we want to do is spike the ball."

Weak Evidence Antidepressants Treat Pain in Older Adults

By Crystal Lindell

New research shows that there’s not much evidence that antidepressants actually work at treating pain in people over 65 years old. 

The study, which comes out of the University of Sydney in Australia, is concerning because older adults with chronic pain are often prescribed antidepressants instead of pain medication. 

However, in a frustrating conclusion, the authors still do not recommend the one medication that is proven to treat pain in older adults: Opioids. 

Instead, they suggest that doctors use a “multidimensional approach using non-pharmacological strategies, such as physical exercise and cognitive behavior therapy.” 

In other words, they essentially conclude that pain patients should get no medication.

However, I am glad that more research is coming out to expose how ineffective antidepressants usually are at treating pain. That class of medication has long been held up as an opioid alternative, despite the fact that many patients don’t get much relief from them. 

The researchers found that international guidelines that recommend antidepressants for chronic pain are heavily based on studies that either exclude older adults or include only a small number of them.  

The researchers found that in the last 40 years there have been just 15 clinical trials globally that focused on the use of antidepressants for pain in older people. And many of them were industry-funded trials with fewer than 100 participants.

The authors say their research fills a much-needed information gap, by bringing together the data from these trials to look at the efficacy and adverse effects of antidepressants for acute and chronic pain in older adults..

They found a lack of evidence to support the use of antidepressants for most pain conditions – despite the fact that they are often recommended in clinical guidelines. And none of the research they analyzed looked at the effectiveness of antidepressants for acute pain, such as shingles or muscular pain.

“These medicines are being prescribed to remedy patients' pain, despite the lack of evidence to adequately inform their use,” said co-author Dr. Christina Abdel Shaheed, an Associate Professor at the University of Sydney’s Institute for Musculoskeletal Health.

The findings mirror those of a recent study in the United Kingdom, which found that there is “no reliable evidence for the long‐term efficacy of any antidepressant, and no reliable evidence for the safety of antidepressants for chronic pain at any time point." 

Withdrawal and Other Side Effects

Shaheed says the potential harms of antidepressants in older people are well documented, and should be factored into any decisions about prescribing the medications. The study found that people taking antidepressants experienced more side effects effects, such as falling, dizziness, and a higher risk of being injured. The potential withdrawal if patients abruptly stop taking antidepressants can also be severe.

The study found that duloxetine, which is sold under that brand names Cymbalta and Yentreve, was able to relieve osteoarthritis knee pain in older adults during the intermediate term, but not short-term or long-term.

As a patient who often shares my health issues publicly, I often get messages and questions from readers who are also dealing with chronic pain. Anytime they mention Cymbalta, I pause. 

I had a horrible experience trying to come off Cymbalta, and I don’t think it even helped much with my pain when I was on it. Plus, my columns about the withdrawal experience apparently resonated, because they are among the most-read, liked and commented on articles I’ve ever written. In other words, it’s not just me. 

If Cymbalta or another antidepressant does help someone, I think they should take it. But I don’t think doctors are fully transparent about how bad the withdrawal can be or how little evidence there is that they even help with pain in the first place. 

“For clinicians and patients who might be using or considering duloxetine for knee osteoarthritis, the message is clear: benefits may be seen with a little persistence, but the effects may be small and need to be weighed up against the risk,” said lead author Dr. Sujita Narayan, an Academic Fellow at the Institute for Musculoskeletal Health.

Again, I’m glad the authors are drawing attention to the problems with prescribing antidepressants for pain management. I just find it alarming that they don’t even bother to mention any alternative medications, and instead suggest non-pharmacological treatments. 

Looking back, I guess I took for granted in the early days of opioid-phobia that most people in the medical field at least recognized that giving zero medication for pain was inhumane. That often meant doctors went from prescribing opioids to prescribing antidepressants. It came with a lot of downsides for patients, but at least it was something. 

If the next stage of opioid-phobia really is just “all medications are bad at treating pain,” then things are worse than I thought. And a lot of people are going to be suffering unnecessarily. 

We already have effective treatments, we just need to use them.

FDA Shutting Down Fentanyl Access Program for Cancer Patients

By Pat Anson

The U.S. Food and Drug Administration is shutting down a pain management program that helped supply fentanyl medication to patients suffering from severe cancer pain.

In a notice published on the FDA’s website for its Transmucosal Immediate-Release Fentanyl Medicines (TIRF) program, the agency said that all TIRF medications “will be discontinued” on September 30.

The program was created due to the risks associated with fentanyl, a synthetic opioid 100 times more potent than morphine. The FDA has required a Risk Evaluation and Mitigation Strategy (REMS) for TIRF medications since 2011.

“Patients currently enrolled in the TIRF REMS may continue their TIRF therapy while supplies remain,” the FDA notice states. “Prescribers currently certified in the TIRF REMS may continue to prescribe TIRF therapy for their currently enrolled patients while supplies remain but must begin working with their patients to transition to other non-TIRF treatments.”

TIRF-REMS has also stopped accepting new applications from patients, prescribers, pharmacies and wholesale drug distributors. According to the FDA, 4,722 patients received a TIRF medication in 2017, but there are currently fewer than 150 patients getting them.

Illicit fentanyl is a notorious street drug that is involved in about 70% of fatal U.S. overdoses. But prescribed fentanyl has long been an essential medicine for patients suffering from surgical pain, breakthrough pain and cancer-related pain. It is also prescribed “off-label” for other types of severe pain.

FDA TIRF-REMS UPDATE

The FDA’s decision to end TIRF-REMS came after Cephalon, which is owned by Teva Pharmaceuticals, notified the agency in August that it was discontinuing production of Actiq, a fentanyl lozenge, and Fentora, a fentanyl buccal tablet. Both medications are absorbed into the bloodstream quickly through the mouth to provide immediate pain relief.  

(Update: On September 16, FDA published a brief statement confirming that TIRF medications are being discontinued, but said the TIRF-REMS program would continue operating while supplies last.

“The TIRF REMS will remain in place as long as the manufacturers’ new drug applications or abbreviated new drug applications are approved, regardless of the marketing status of the products,” the agency said. “FDA did not request this discontinuation. It is important to note that FDA does not manufacture medicine and cannot require a pharmaceutical company to make a medicine, make more of a medicine, or change the distribution of a medicine.”

Teva did not respond to requests for comment about the discontinuations. Actiq and Fentora are expensive medications. A supply of 30 Actiq 400 mcg lozenges costs about $3,500, while 28 tablets of Fentora 100 mcg will cost about $2,300.

“I had very few patients on these medications in the past, since no health insurers would actually pay for them,” said Chad Kollas, MD, a palliative care physician and pain policy expert. “I think it’s problematic that the TIRF-REMS website isn’t offering recommendations for an effective alternative approach for the patients currently using TIRF products.”

Opioid litigation and the risk of further liability may have influenced Teva’s decision to discontinue TIRF medication. The company agreed to pay $4.24 billion to settle allegations that it illegally marketed opioids and failed to prevent their diversion.

Last year, Teva discontinued production of immediate release oxycodone as part of a strategic shift away from less profitable generic drugs.

Deception Was Used to Get Patients to Participate in Opioid Study

By Pat Anson

“We are lying to you to see if you are lying to us.”

That’s how patient advocate Andrea Anderson sums up the Orwellian methodology behind a recent study that explored whether pain patients are taking their opioid medication appropriately.

The study made use of high-tech pill bottles that record in real-time how often a bottle is opened and any changes to its weight. The goal is to see if patients adhered to their opioid regimen or were taking too many pills at once – a possible sign of abuse or diversion.

Researchers at the University of Texas Medical Branch (UTMB) enrolled 28 chronic pain patients in the study, giving participants a 90-day supply of opioids in three 30-dose pill bottles. Eighteen patients were given pills in the high-tech bottles --- known as the medication event monitoring system (MEMS) --- while the other 10 were given standard pill bottles. Patients in both groups were asked to keep a daily diary of their medication use

Here’s where the lying comes in. Instead of telling participants that the MEMS bottles would keep track of pills being removed, patients were told that the temperature and humidity inside the bottles were being monitored.

“The study involved incomplete disclosure and deception, as participants were informed that the purpose of the study was to test a new prescription bottle that will monitor the physical environment inside the bottle…. Participants were not informed that the bottles would record the number and timing of pills dispensed,” wrote lead author David Houghton, PhD, an Assistant Professor of Psychiatry and Behavioral Sciences at the Center for Addiction Research at UTMB.

You might think that lying and deception would be prohibited in clinical trials, but the design of this study was approved by an ethics review panel at UTMB. Researchers say they also complied with international research guidelines that allow deception to be used in psychology studies “when there is no alternative method that will produce reliable and valid results.”

At first glance, the study findings suggest that many patients were less than honest about their opioid use.

“Participants who received MEMS demonstrated highly heterogenous dosing patterns, with a substantial number of patients rapidly removing excessive amounts of medication and/or ‘stockpiling’ medication,” researchers reported in the Journal of Pain Research.

“Several sharp decreases in medication supply over short time periods were observed, and a substantial portion of participants ran out of medication before 30 days had elapsed. These data could reflect over-consumption or diversion of medication.”

In addition, 25% of participants in the MEMS group tested negative for opioid metabolites in their urine drug tests, which suggests they may have been hoarding or selling their opioids, and not taking them.

‘Hypothetically Significant’

But the small size of the study – just 18 patients in the MEMS group – raises questions about the reliability of the findings.

Diversion of opioid medication is actually quite rare – about three-tenths of one percent of prescribed pills, according to the DEA.

It’s also not uncommon for patients to stockpile opioid medication. In a recent PNN survey of nearly 3,000 pain patients, 32% told us that they hoarded opioids, in many cases because they are worried about shortages or losing access to opioids in the future.

Although participants in the UTMB study were told to remove pills from their bottles just before taking them, it’s possible that they took out an extra amount simply to fill their weekly pill boxes.

Researchers were also surprised to find that some participants appeared to put pills back into the bottles, another sign that those “highly heterogenous dosing patterns” tell us little, if anything, about opioid use.

In other words, the study may be nothing more than a case of “garbage in, garbage out,” with any number of reasonable explanations for patient behavior.

“It is impossible to conclusively determine that aberrant behavior, as recorded by the MEMS system, reflects misuse or diversion,” researchers admitted.

“It’s a terrible study in every way, and should never have happened,” says Andrea Anderson, who sees obvious flaws in MEMS that make its data unreliable. 

“If you wanted to divert your tablets, you could just take out the proper amount every time the stupid bottlecap lets you. Once you collected 20 tablets, you could go sell them if you wanted or take however many you liked. It certainly won’t prevent any type of diversion or misuse.”

Nevertheless, as is often the case in opioid research, sweeping conclusions were drawn from skimpy evidence. The UTMB researchers found enough “hypothetically significant clinical implications” to call for full-time monitoring of patients and their opioid use.

“These results highlight the limits in our understanding of naturalistic patterns of daily opioid use in chronic pain patients as well as support the use of MEMS for detecting potential misuse as compared to routine adherence monitoring methods. Future research directions include the need to determine how MEMS could be used to improve patient outcomes, minimize harm, and aid in clinical decision-making,” they concluded.

There is a company working on just that. Kansas-based SMRxT supplied UTMB researchers with the MEMS bottles and data used in the study. The company says its MEMS technology could be used to assign risk scores to patients – what it calls an “Absolute Adherence Score” – similar to the controversial Narxcare scores that assess a patient’s risk of opioid misuse and addiction based on their prescription drug history.   

“The SMRxT medication adherence system accurately captures data to reveal how patients take their medication. The system empowers and improves patient behavior,” the company claims in promotional material. “Once the prescription is filled, the device is ready to use. The system then translates data into actionable information for patient interventions and engagement.”

“We enjoyed working with the team at UTMB,” a spokesperson for SMRxT told PNN. “Our device is not in the development stage, and has been used by patients all over the country and many other academic research institutions.”