More Lackluster Results for Non-Opioid Pain Reliever

By Pat Anson

New questions are being raised about the effectiveness of an experimental analgesic and whether it can be a viable alternative to opioid pain medication.

Results from Vertex Pharmaceuticals’ Phase 2 clinical trial show that suzetrigine is essentially no more effective than a placebo in relieving back and hip pain caused by lumbosacral radiculopathy (LSR).

After 12 weeks of treatment with suzetrigine, patients with LSR had a 2.02 average reduction in their pain scores on a rating scale of zero to 10. That compares to an average reduction of 1.98 for patients who received a placebo or sham treatment.

Although the difference between 2.02 and 1.98 is statistically meaningless, Vertex claimed the overall findings were “statistically significant and clinically meaningful” in a press release. The company blamed the lackluster results on the placebo effect and the difficulty of treating lumbosacral radiculopathy.

“Suzetrigine has again demonstrated its potential to fill an important unmet need in the treatment of pain,” said Carmen Bozic, MD, Executive Vice President and Chief Medical Officer at Vertex. “We did not see separation between the suzetrigine and the placebo arms. Yet our post-hoc analyses suggest that this could be due to the high placebo response in this study.”

Despite the disappointing results, Vertex still plans to go ahead with a Phase 3 study of suzetrigine for LSR, while changing the study design to minimize the impact of the placebo.

“Managing the placebo response in pain trials is a complex challenge. We look forward to innovating in clinical trial design, including for the pivotal study, with the aim of bringing a potentially safe and effective treatment to patients suffering from LSR," said Christine Sang, MD, co-chair of Vertex’s Peripheral Neuropathic Pain steering committee and principal investigator of the study.

Suzetrigine is already under consideration by the FDA as a treatment for acute pain, with a decision expected in late January. If approved, suzetrigine would be the first new medication for acute pain in over two decades.

Unlike opioids, suzetrigine blocks pain signals in the peripheral nervous system before they reach the brain. That means it won’t have the “liking” effect that opioids can have in some patients or be as addictive.

Although suzetrigine has been touted as a novel painkiller that "could bring relief to millions” without the risk of addiction, findings from earlier studies have also been mixed. In a Phase 3 trial of patients recovering from minimally invasive surgery, suzetrigine was no more effective than a low dose combination of hydrocodone and acetaminophen, more commonly known as Vicodin.

Although Vertex downplayed the results from the Phase 2 study, shares of the company lost about 15% of their value after last week’s announcement. Wall Street analysts said the Phase 2 findings were “very messy” and "raise considerable risk around suzetrigine's potential.”

Ultimately, it will be up to the FDA to decide whether suzetrigine should be allowed on the market. The agency is under pressure to approve new non-opioid analgesics, so it may look past the disappointing clinical trial findings. If approval is granted in January, it will coincide with implementation of the NOPAIN Act, which will make non-opioid analgesics in outpatient surgical settings eligible for higher Medicare reimbursement rates.  

In addition to acute pain and lumbosacral radiculopathy, Vertex is also studying suzetrigine as a treatment for diabetic peripheral neuropathy.

CVS Pushes Back Against DOJ’s Latest Opioid Lawsuit

By Crystal Lindell

The U.S. Justice Department’s latest opioid lawsuit against CVS is getting some push back from the pharmacy chain. The DOJ alleges that CVS knowingly filled “unlawful prescriptions” for opioids and other controlled substances, and then sought reimbursement for them from federal healthcare programs like Medicaid and Medicare.

Specifically, the DOJ claims that CVS had “corporate-mandated performance metrics” that incentivized pharmacists to fill the prescriptions. The government also alleges that CVS “set staffing levels far too low” for pharmacists to meet their corporate goals and legal obligations.

“Our complaint alleges that CVS repeatedly filled controlled substance prescriptions that were unlawful and pressured its pharmacists to fill such prescriptions without taking the time needed to confirm their validity,” Deputy Assistant Attorney General Brian Boynton said in a statement. “The practices alleged contributed to the opioid crisis and opioid-related deaths.”

CVS issued a statement in response to the lawsuit that “strongly disagrees with the allegations and false narrative.” The company said the standards the DOJ is claiming CVS didn’t meet are so vague and ever-changing as to be useless. 

“The government’s lawsuit seeks to impose a shifting standard for pharmacy practice,” CVS said. “Many of the litigation theories laid out in the complaint are not found in any statute or regulation, and relate to topics on which the government has declined to provide guidance.

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

I have to say, it’s good to see CVS defend itself in these situations. 

Especially by pointing out the obvious: The prescriptions were written by doctors who were licensed by the government. Although pharmacists have a “corresponding authority” to make sure a prescription is legitimate, why should a private pharmacy chain be held to a higher standard than the government itself?

The government’s lawsuit intensifies a serious dilemma for the pharmacy industry, which is simultaneously second-guessed for dispensing too many opioids and for filling too few. 

Over the last few years, it seems like every government agency in existence has been looking for anyone they could possibly sue in relation to opioids. As a result, about $50 billion in opioid settlement money will be paid in coming years by opioid makers, distributors and pharmacies.

However, there’s one glaring aspect of this tactic that makes it clear the lawsuits aren’t about helping people hurt by opioids, but about finding ways for the government and plaintiff law firms to get more money. Much of the settlement money received so far has been earmarked for law enforcement and other government projects that have little to do with opioids.

‘We Will Defend Ourselves’

CVS has already agreed to pay about $5 billion to settle opioid litigation. The company says the latest lawsuit, which seeks unspecified additional penalties, is just another cash grab.

“We will defend ourselves vigorously against this misguided federal lawsuit, which follows on the heels of years of litigation over these issues by state and local governments — claims that already have been largely resolved by a global agreement with the participating state Attorneys General,” the company said. 

CVS says it has been an “industry leader” in developing programs to fight opioid misuse. In recent years, the nation’s largest pharmacy chain has refused to fill controlled substance prescriptions written by over 1,250 doctors, about half of whom the government continues to license. 

The company also points to its “Our Opioid Response” website, which features a telling headline about government regulations and the scrutiny faced by pharmacists: 

“Fill this opioid prescription. No, wait, actually you can’t do that. Or, maybe, you can: The dilemma for community pharmacists.”

The text on the site then goes on to again point out the DEA’s vague guidance and inconsistent stance on the issue. 

“Whichever decision they make, community pharmacists know they can – and will – be second-guessed later. Too often, we have seen government agencies and trial lawyers question the good-faith decisions made by pharmacists while a patient waits at the pharmacy counter, often in pain. While simultaneously being accused of dispensing too few opioids and too many, pharmacists and pharmacies face threats of liability no matter their actions,” CVS said.

A recent court case suggests that CVS and other pharmacy chains are making some headway in defending themselves. The Ohio Supreme Court ruled this week that CVS, Walmart and Walgreens are not “public nuisances” under the state’s product liability law. Similar rulings have also been made in West Virginia, California and Oklahoma, rejecting public nuisance claims that resulted in costly opioid settlements.

CVS says it is standing up for “patients enduring relentless pain,” and as a patient who faces relentless pain, I’m happy to see it. While I’m skeptical that the overall tide is turning when it comes to public attitudes about opioids, it’s good to know at least one company is pushing back. 

Anthem Blue Cross Blue Shield Under Fire for Limits in Anesthesia Coverage

By Pat Anson

One of the nation’s largest health insurers is under fire for making plans to cutoff coverage of anesthesia care if a surgery or procedure lasts too long. The criticism was so widespread, Anthem Blue Cross Blue Shield reversed course and said it would not implement the policy.

In early November, Anthem said it will not allow anesthesiologists to bill for services that exceed time frame standards adopted by the Centers for Medicare and Medicaid Services (CMS). The only exceptions were for patients under the age of 22 and for maternity-related care.

Anthem’s policy would have applied to hundreds of procedures on specific body areas, including the head, neck, spine, leg and elbow. The anesthesia services covered include general anesthesia, when a patient is kept unconscious during a major operation, as well as local and regional anesthesia, which would include epidurals, nerve blocks and injections that numb selected areas.

“We will utilize the CMS Physician Work Time values to target the number of minutes reported for anesthesia services. Claims submitted with reported time above the established number of minutes will be denied,” Anthem said in a notice sent to providers in New York state.

The proposed policy covered to all anesthesia care that occurs before, during and after surgery – meaning the clock would start ticking the minute an anesthesiologist goes to work.

“Ridiculous. Does Anthem expect a patient to get up in the middle of a surgery and walk away?” New York State Sen. Mike Gianaris tweeted.

“As someone who has had 10 surgeries in the last 17 years, I have NEVER had a surgery end sooner than the estimated time. What Anthem Blue Cross Blue Shield is proposing is MONSTROUS,” patient advocate Peter Morley posted on Bluesky. “Fortunately I have Medicare but don’t think this doesn’t weigh heavily on me and others preparing for surgery now & in the future. How many will cancel their surgeries because of this?”

In addition to New York, Anthem also sent notices about the policy change to providers in Connecticut, Missouri and Colorado. It’s not clear if other states would be affected.

“This is just the latest in a long line of appalling behavior by commercial health insurers looking to drive their profits up at the expense of patients and physicians providing essential care,” Donald Arnold, MD, President of the American Society of Anesthesiologists (ASA), said in a statement.

“It’s a cynical money grab by Anthem, designed to take advantage of the commitment anesthesiologists make thousands of times each day to provide their patients with expert, complete and safe anesthesia care. This egregious policy breaks the trust between Anthem and its policyholders who expect their health insurer to pay physicians for the entirety of the care they need.”

The ASA urged people opposed to Anthem’s plan to contact their state insurance commissioner or state legislators.

Although Anthem’s policy was announced over a month ago, it only recently started attracting public attention and outrage.

“This is appalling. Saddling patients with thousands of dollars in surprise additional medical debt. And for what? Just to boost corporate profits?” tweeted Sen. Chris Murphy of Connecticut.  

In response to the backlash, Anthem released a new statement today claiming it was all a misunderstanding.

“There has been significant widespread misinformation about an update to our anesthesia policy. As a result, we have decided to not proceed with this policy change,” the company said. “To be clear, it never was and never will be the policy of Anthem Blue Cross Blue Shield to not pay for medically necessary anesthesia services. The proposed update to the policy was only designed to clarify the appropriateness of anesthesia consistent with well-established clinical guidelines.”

Elevance Health, the parent company of Anthem, recently reported operating revenue of $44.7 billion in the third quarter of 2024, an increase of $2.2 billion from the same period a year ago. Elevance provides insurance, pharmacy and medical services to about 113 million consumers.

Gabapentinoids Raise Risk of Hip Fracture in Older Adults

By Pat Anson

Many patients have learned – the hard way – that nerve medications known as gabapentinoids have over a dozen potential side effects, from brain fog and sleepiness to weight gain and mood changes.

You can now add hip fractures to the list.

A study at Australia’s Monash University found that gabapentinoids such as Lyrica (pregabalin) and Neurontin (gabapentin) significantly raise the risk of hip fractures, especially in older adults who are frail or have kidney disease.

The study, recently published in JAMA Network Open, tracked nearly 3,000 patients aged 50 and older who were hospitalized for hip fractures in Victoria, Australia from 2013 to 2018. Among those 80 and older, nearly 60% were prescribed a gabapentinoid before being admitted, with most of them using pregabalin (94%).  

After adjusting for comorbidities and the use of other medications, researchers estimate that people over age 50 have a 30% higher risk of hip fractures within 60 days of gabapentinoid dispensing. The risk is even higher for patients with chronic kidney disease (141%) and those with high scores for frailty (75%).

“Our results showed patients had 30 per cent increased odds of suffering a hip fracture within two months of being dispensed a gabapentinoid medication,” said co-author Simon Bell, PhD, Professor and Director of the Centre for Medicine Use and Safety at the Monash Institute of Pharmaceutical Sciences. 

“The link between gabapentinoids and hip fractures existed across different age groups but the odds of hip fracture was higher among patients who were frailer or had chronic kidney disease, so these should be important considerations when deciding when to prescribe gabapentinoids.” 

Bell and his colleagues did not establish why gabapentinoids raise the risk of hip fractures, but they suspect the medications increase the risk of falling in older adults, similar to other psychotropic drugs such as anti-depressants, benzodiazepines and opioids.

“Our findings highlight the importance of assessing each patient’s risk before prescribing gabapentinoids,” said lead author Miriam Leung, PhD, a Teaching Associate at the Centre for Medicine Use and Safety at Monash University.

Despite limited evidence of their effectiveness as pain relievers, gabapentinoid use has risen significantly in recent years for neuropathy, fibromyalgia and other chronic pain conditions. The drugs are also increasingly used for acute pain, such as postoperative pain and even dental pain.

A 2019 study found little evidence that gabapentin and pregabalin should be used for pain and said their effectiveness was often exaggerated by prescribing guidelines.

In the United States, nearly 5% of the adult population uses a gabapentinoid, while in Australia 1 in 7 people aged 80 and older is prescribed the nerve medication.

Low Dose Opioids Do Not Raise Dementia Risk, But High Doses Might

By Crystal Lindell

There’s a new study out showing that low-dose opioids are not linked to an increased risk of developing dementia, but higher doses might. 

Researchers followed the health of over 1.8 million people in Denmark aged 60 to 75, about 5% of whom developed dementia. They tracked the opioid use of those with and without dementia to see what role, if any, opioids may have in causing cognitive decline.

They found that low dose opioids prescribed for chronic non-cancer pain — which they defined as up to 90 total standardized doses (TSDs) — was not consistently associated with dementia risk. However, doses above 90 TSD were associated with a slightly elevated dementia risk before age 90. 

Interestingly, the strongest association between opioids and dementia was found with “weak” opioids such as tramadol.

Total standardized doses are a different way of measuring opioid use than what is typically used in the United States. Medical guidelines in the U.S. focus on morphine milligram equivalents (MME) per day. Depending on the guideline, anything over 50 or 90 MME would be considered a high dose.   

For the Danish study, 1 TSD is the equivalent of 30 MME. So someone with a TSD of 90 is getting the equivalent of 2,700 MME over time. Researchers used this method because they wanted to see what the cumulative effect of opioids would have on dementia.  

“This study found that opioid use of less than 90 TSDs was not significantly associated with increased dementia risk. Above 90 TSDs of opioid use was associated with an elevated dementia risk before age 90 years, which persisted in individuals with chronic noncancer pain and in individuals solely exposed to weak opioids,” researchers reported in JAMA Network Open,.

They also added the favorite caveat of medical researchers everywhere: “Further research should ascertain whether the findings denote causality between opioids and dementia risk.” 

In other words, it is still unclear if taking higher doses of opioids leads to dementia, or if chronic pain puts people at higher risk of dementia. It’s a chicken and egg question without any answers. 

A previous study also found that high doses of opioids slightly raise the risk of dementia, but so did nonsteroidal anti-inflammatory drugs (NSAIDs). So switching someone from opioids to NSAID pain relievers won’t lower their risk.  

Regardless, given the findings in the Danish study about the lower doses, I am glad to see some more definitive evidence that opioids aren’t the cause of every ailment ever. 

I do worry that the study even existing will perpetuate harmful opioid-phobia myths though. For example, the study’s headline – “Opioids and Dementia in the Danish Population” – is just vague enough that casual readers may assume that the research did show a link between opioids and dementia, regardless of the dose. 

It also irks me that researchers included the favorite sentence of opioid-phobia propagandists: "Opioids are frequently used to treat chronic noncancer pain, but evidence of the effect on pain management and quality of life is lacking." 

As usual, the fact that millions of people around the world have told doctors that opioids help their pain is apparently not “evidence.” They can’t trust any of us.  

As someone who’s been on what the researchers would consider “low dose” opioids since I was 29 years old, I can tell you they do help manage my pain and give me a better quality of life. If the researchers found a higher dementia risk for me, I’d still keep taking opioids. 

Opioids are the only thing that allows me to live my life today. I’m not going to give that up because I might have a higher risk of dementia decades from now. In fact, if I did give them up, I suspect there’s a high chance that I would not make it into my senior years anyway, seeing as how opioids are often the only thing that makes my daily pain endurable. 

I suspect I’m not alone. Research like this is unlikely to deter most pain patients from taking opioids, but it could make some doctors hesitant to prescribe them. And that’s a shame. Because a study showing that low-dose opioids aren’t as bad as some feared should make doctors more comfortable prescribing them.

Shingles and My 10-Year-Old Bottle of Vicodin

By Cynthia Toussaint

A few years ago, a friend who’d been through a rowdy case of shingles tried to spook me.

“You of all people, Cynthia, have to get the shingles vaccine. You couldn’t go through this level of pain with all you’ve got going on,” she said.

Yeah, yeah, I thought, normies who don’t live with the flame-broiler called Complex Regional Pain Syndrome can’t hack the small stuff.

While Laura’s warning was well-intentioned, I decided to skip the shot because I’d heard it was a real ass kicker. That, and I’m already an Olympic-level pro at neuropathic pain. I’d be fine without getting the shingles vaccine.      

I bet on the wrong horse.    

In early August, a mysterious pain on the side of my left leg woke me. I’d never had aching pain that hurt so much, and rousted my partner John in alarm. Muscling through my day, the ache turned lava hot while I moaned and yelped. By bedtime, I was writhing and screaming. No position offered a smidge of relief and I ended up pretzelled against the foot board after only a couple hours of sleep.   

I couldn’t make heads or tails of this new pain. It burned something fierce like CRPS, but was unfamiliar. Terrified, I pointed out to John the places on my thigh where piercing pain, like striking arrows, were erupting. Worse, there was a “hatchet” in my groin.

42 years into CRPS, could this be a different kind of pain rearing its ugly head? The new version came complete with a high fever and wipe-out fatigue.

No amount of my old standby’s – rest, heat, distraction, kitty cuddling – offered relief. In fact, the pain kept amping higher, rendering me useless.

Soon, a bright-red, ghoulish rash appeared and began to spread by the hour. It felt like I was starring in my own horror film, with no pause button on the remote.

The next day, it hit me. This is goddamn shingles and I scooted off to an immediate care clinic.

I was disappointed to get a young male doctor and, true to form, he dismissed my symptoms by announcing that I’d burned myself with a heating pad. His only advice was for me to take a picture of the rash for reasons unknown. 

That night, while the rash continued to march on, the redness turned to bubbling blisters, and the next day I found myself back at immediate care.   

This time at the clinic I hit the jackpot, as a skilled and caring female doctor took about three seconds to diagnose shingles. Livid over the previous day’s dismissal, as treatment time was now of the essence, she instructed me to immediately pick up anti-viral medication and start them as soon as I got home.

Before leaving the room, she gave me a major fright. She looked into my eyes and told me that my shingles might become chronic, especially with my long CRPS history. At that moment, I had no doubt I was in for a world of unchartered hurt.                

For the next two months, except for doctor appointments, I lived between my bed and the couch, surviving one minute at a time. The blisters spread from the top of my thigh down to my knee, and up onto my left buttocks. Mixed with exquisite pain were patches of numbness, and my dermatologist gently warned that this might indicate nerve death.        

My allodynia was so severe I couldn’t bear anything touching the rash, and the never-ending pain kept me awake nights. I despised hearing from doctors, again and again, that I had the worst case of shingles they’d ever seen. Their biggest concern was that the rash would spread to my right side, in which case they suspected it would travel to my eyes and I’d likely lose my sight.   

Vicodin to the Rescue

The pain got so bad, John pleaded with me to take a Vicodin from a 10-year-old bottle he’d asked me to keep, just in case. In the past, this was unthinkable as my primary physician warned me that, due to being on a benzodiazepine, combining both medications might suppress my breathing. Despite that, I didn’t hesitate and got my first taste of blessed relief.

Soon my frantic pain doctor directed me to up my dose to four 5mg Vicodin tablets a day. Scared due to being opioid-naïve, I went on three instead. I could survive the pain then, but had zero quality of life. During this miserable time, I gulped laxatives to keep the pipes flowing, and for 10 days hobbled no further than our condo balcony. I was slowly cancelling my life and couldn’t even tolerate a visitor.

I ruminated over worst case scenarios. What if my pain stays chronic at a level ten? Also, my dermatologist told me I might be scarred forever.

Even if my pain improves, could I ever show my disfigured leg in public? Upon seeing the angry rash, my sister-in-law innocently chirped, “You can’t get in the pool with that, Cynthia. It’ll frighten the other swimmers.” I knew she was right and wanted to sob.

Mercifully, in the last month, the pain and rash (four tubes of scar gel and counting!) started to retreat, bit by bit. With great trepidation, I successfully weaned off the Vicodin, but sure enough, I’m left with post-herpetic neuralgia, the chronic pain I so dreaded.

While my numbness and allodynia are improving, the hatchet pain in my groin hasn’t dissipated. I’m over-the-moon happy to be swimming again with no problem, but for the first time this former ballerina is less than limber on her left side, which makes Pilates and Feldenkrais movement therapy formidable challenges.

While there are no guarantees, I remain optimistic for total healing because I take such good care of my body and mind. Three cheers for self-care!

Hands down, shingles at its apex was the worst pain experience of my life, and because of my CRPS, it was far, FAR worse than what a healthy person would have experienced. My doctors and I suspect the immunotherapy I took for cancer care over two years ago played a major role in getting shingles now, as it’s been the root of three prior serious pain complications.                   

While I can’t go back in time and take Laura’s sage advice about getting the almighty shingles vaccine, I can share my cautionary tale in hopes you’ll do so. With a caveat, I shuddered to learn the vaccine – which I’ll be getting in February – isn’t full proof. Inoculated folk can still get shingles, but those cases are rare and usually less severe, which is especially beneficial for those already wrangling with neuropathic pain.          

While I’m slowly moving my shingles nightmare (albeit with PTSD) into the rearview mirror, I’m haunted by a horrific question. Because my pharmacy refused to fill my pain doctor’s new prescription for Vicodin, what would have happened to me if not for my 10-year-old bottle?

In the grips of the worst pain and torture I’ve ever experienced and the absolute hopelessness of relief, in desperation what might I have done?

I don’t know, but am glad as hell I didn’t have to find out. My god, where is the mercy for people with pain?

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome (CRPS) and multiple co-morbidities for over four decades, and has been battling cancer since 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.” 

ER Opioids ‘Extremely Unlikely’ to Lead to Addiction

By Pat Anson

Many patients in pain have horror stories to share about their experiences in hospital emergency rooms, where they’ve been treated as drug seekers and denied opioid medication.

“I had a broken arm and was given nothing for pain when leaving the emergency room,” one patient told us. “They now treat everyone like a drug seeking addict even if you have legitimate pain!”

“My last ER visit has caused me PTSD. It was awful they put me in a room and turned the light off and left me there for hours,” said another.

“The emergency rooms are horrible,” said a patient with a fractured rib. “I wasn’t even asking the ER for meds. I wanted an x-ray or something because I was in excruciating pain.”

Are fears about opioid addiction justified? A new study found that the risk of developing opioid use disorder after being treated with intravenous opioids in the ER is quite low – less than one-tenth of one percent (0.002%).

Out of 506 patients treated with IV opioids in two Bronx emergency rooms, only one met the criteria for long-term or persistent opioid use six months later.

“These data suggest that the use of IV opioids for acute pain among opioid-naive patients is extremely unlikely to result in persistent opioid use,” wrote lead author Eddie Irizarry, MD, an emergency medicine physician at Montefiore Medical Center.

“Opioid naïve” means the patients had never taken opioids before or only used the drugs infrequently.

The study, recently published in The Journal of Emergency Medicine, defines persistent use as filling six or more opioid prescriptions in the 6 months after an ER visit, or an average of one prescription per month.

The most frequently reported IV opioid administered in the ER was morphine (94%), followed by hydromorphone (4%) or a combination of both morphine and hydromorphone (2%). The researchers noted that most of the morphine doses were “relatively modest.”

After being treated in the ER, 63 of the patients (12%) received an opioid prescription on discharge.   

The researchers cautioned that opioids should be used “judiciously” and that many ER patients could be treated with non-opioid analgesics such as acetaminophen. But they could find no evidence that IV opioids should be routinely denied in the ER.

“We are not aware of compelling data to support denying parenteral opioids to opioid-naïve patients who are suffering from severe acute pain,” said Irizarry.   

The research mirrors the findings from a 2017 Mayo Clinic study, which found that the risk of long-term opioid use is lower for ER patients than it is for patients treated in other medical settings. In the Mayo study, 1.1% of opioid naive patients became long term users. That compares to 2% of patients who were prescribed opioids in non-emergency settings.

FDA’s New Rules Aim to Make Pharma Ads Easier to Understand

By Crystal Lindell

The Food and Drug Administration is hoping that its new rules will make pharmaceutical ads on TV and radio easier to understand. 

Commercials for pharmaceutical drugs must now include a “major statement” about side effects and contraindications in “a clear, conspicuous, and neutral manner.” The rule applies to direct-to-consumer (DTC) ads for prescription drugs and what conditions they are used to treat. 

The new regulations are a response to something many drug makers figured out long ago: people tend to tune out when they start to hear a long list of potential side effects and interactions, which are usually rushed through at the end of drug commercials. By then, consumers may have tuned out the downsides of the medication. 

“If you’re a company and you’re worried about possible FDA enforcement or product liability and other litigation, all your incentives are to say more, not less,” Torrey Cope, a food and drug lawyer, told the AP.

The law firm Lerman Senter broke down the five new standards the FDA requires companies to meet in drug ads. All commercials must now include:

1. Consumer Friendly Language: Ads must clearly state the name of the drug, and a major statement of side effects must be presented in language that is readily understandable. It should not include technical or medical jargon.
   

2. Understandable Audio: Audio information must be understandable in terms of volume, articulation and pacing, and should be as understandable as the rest of the commercial. “Rapid fire” disclosures will no longer be permitted.
   

3. Major Statement Must Be Presented Concurrently in Text and Audio: Television ads must present the major statement simultaneously in the audio and visual sections.
   

4. Text Must Be Easily Readable: The on-screen text must be presented against a contrasting background for sufficient duration, and in a font size and style that is easily readable.
   

5. No Distractions. Advertisements cannot have statements, text, images or sounds that detract from comprehension of the major statement. No other sounds, including music or catchy jingles, should be heard during the side effects disclosure.

While the rule went into effect a few months ago, companies have until November 20 to be in full compliance. So while you may have already noticed pharma ads changing, all of them should be in compliance starting this week. 

In its report about the changes, the FDA said that while drug ads often have a caveat urging people to “ask your doctor” about a medication, pharmaceutical companies are incentivized to make the ads deceptive in various ways. 

“Like all advertisers, prescription drug firms have ample business incentives to present their products in a positive light to potential consumers,” the FDA said. “But those business incentives do not assure clear communication of the advertised drug’s negative attributes to consumers.”

While no federal law has ever banned pharmaceutical companies from directly advertising to consumers, the practice didn't really take off until about 40 years ago. Currently, the United States and New Zealand are the only two countries that allow DTC drug advertising. 

In its report, “Background on Drug Advertising,” the FDA explains: 

"Until the mid-1980s, drug companies gave information about prescription drugs only to doctors and pharmacists. When these professionals thought it appropriate, they gave that information to their patients. However, during the 1980s, some drug companies started to give the general public more direct access to this information through DTC ads."

As someone who was born in the mid 1980s, I remember being surprised as an adult when I learned that most other countries ban pharma companies from advertising directly to consumers. 

While it’s difficult to imagine that the U.S. would ever ban the ads completely, there’s definitely a good case for heavily regulating them. A 2005 study found pharmaceutical ads that encouraged consumers to talk with their doctors “have a profound effect on physician prescribing” and could promote overuse or inappropriate prescribing.

In other words, drug companies are very good at creating ads that make people want to buy their products, whether they need them or not. Let’s be real: if drug advertising didn’t work, companies would not be spending over $15 billion a year promoting their medications. 

I’m glad to see the FDA amping up these regulations, so people have a better understanding of drug ads. But it remains to be seen how these agency regulations will hold up under the incoming Trump administration.   

The Stress of Navigating Opioid Shortages As a Patient

By Crystal Lindell

At 9:30 am Monday morning, I got one of the most dreaded phone calls that someone taking a controlled substance can get – my pharmacy was completely out of my pain medication, Morphine Sul ER. 

Chronic shortages of prescription opioids were finally impacting me directly. 

At first, the pharmacist tried to make it sound like there was just a small delay, asking me, “How how many pills you have left?”

None. I had none left. Because pain medication refills usually aren’t filled until you completely run out. There’s not even a one-day leeway built in, because god forbid pain patients have one extra pill ever. 

Even if I did have some left, I couldn’t tell the pharmacist that, because it might risk having that used against me later. Afterall, if I had extras, that shows that I don’t need to be prescribed as many pills as I was getting. 

You’re always risking something as a pain patient. If you try to plan too far ahead by stockpiling extra pills, they could use that to reduce what you’re prescribed. And if you don’t plan ahead at all, you risk physical pain and withdrawal if there are any issues getting your refill – issues beyond your control like a drug shortage. 

As it turned out, it wouldn’t have mattered if I did have some pills leftover because the situation was worse than the pharmacist was initially letting on. This wasn’t an issue of waiting for an afternoon shipment or even a next-day restock. The pharmacist didn’t know when my medication would be back in stock at all. 

She said she had been requesting more pain medication every day, but their supplier wasn’t providing any updates on a timeline for when that would happen. So she suggested that I call around to other pharmacies to see if any of them had it in stock. 

There’s just one problem: the pain contract I had to sign to get a monthly opioid prescription technically bans me from getting refills at different pharmacies. I don’t think there are any exceptions in the contract. And if I break it, I risk losing access to the only medication that makes it possible for me to function on a daily basis. 

So even if I could find another pharmacy, I wasn’t sure if my doctor would let me get the medication filled there. 

The pharmacist was surprisingly understanding of this, and said that she had already called my doctor before calling me, so she was hopeful that they would be accommodating. 

At that point I realized that any plans I had for my Monday morning were now canceled, because I was going to have to spend the next few hours trying to navigate this. 

I made one last attempt to get the situation resolved without having to loop in another pharmacy, asking if they had an alternative medication that wasn’t too expensive because I don’t have health insurance. My medication is an extended release opioid, and the pharmacists said all they really had was the instant-release versions – which I knew my doctor would not want to swap in.

So, another pharmacy it would have to be. 

I did wonder for a moment if my pharmacy was lying to me about being out of stock. It was just last month that I had to negotiate the price of this same medication with them after they tried to increase the price by $50. 

Maybe they just didn’t want to deal with me, a long-term opioid patient, any more. So after the attempted price increase failed to deter me, they were trying a different tactic. 

The thing is, how would I even find that out? As far as I know, there’s no accountability for pharmacies that lie to patients about why they aren’t able to fill a prescription. Most people understand why that’s concerning when it comes to things like birth control or insulin, but when it’s pain medication, the general public tends to side with the pharmacist who doesn’t want to fill the prescription. 

At that point, I started calling other pharmacies. Thankfully, a locally owned one said they had the medication in stock and that they could fill it. I called my doctor to see if they’d transfer the prescription, and his receptionist took down the message. Then, I waited. 

I spent the next few hours anxious about whether this would all work out, and how long it would be until I got my refill. Finally, at about 1 pm, I saw in MyChart that the medication had been sent to the new pharmacy. 

Then I called the new pharmacy to make sure they saw my prescription come through and to ask what the cash price was. It was going to be $52, about $16 more than I paid at the other pharmacy. I probably could have asked them about using a GoodRx coupon, but I was already throwing a controlled substance prescription on them at the last minute, and they had it in stock, so I didn’t want to make waves. 

A few hours later it was finally filled, sort of. At 3 pm I arrived at the pharmacy to pick it up, after driving 25 minutes on rural roads to get there. 

They handed me the bottle and said, “Oh, by the way, we’re two pills short. Hopefully we will have those in for you later this week. So you can come back and pick them up then.”

Another 50 minutes of round-trip driving was suddenly in my future. 

I’m thankful that I found a pharmacy with any of my medication in stock, and I’m happy that my doctor seemed to handle the prescription transfer without issue. 

What Happens Next Month?

But the entire, stressful ordeal wiped out most of my day, and now I also have to figure out what will happen next month. 

Will the shortage impacting my medication be handled by then? Or should I try to have my doctor switch my prescription to something else? And if he did that, how much would that medication cost? Should I have my prescriptions permanently transferred to the other pharmacy? Is the one I normally go to going to give me a hassle every month now?

If medication shortages don’t impact you directly, it can be easy to gloss over reports like the one from the American Society of Health-System Pharmacists (ASHP), which found that shortages of drugs used for pain, anesthesia, chemotherapy and attention-deficit/hyperactivity disorder (ADHD) “continue to be problematic.” 

Those shortages impact real people. Despite a stressful morning, I was among the lucky ones, as I was able to get it worked out within just one day. Who knows if that will be the case next month though. 

The ASHP cited reduced DEA production quotas and the fallout from opioid litigation as some of the reasons for the drug shortages, which have led to rationing at many pharmacies. In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled at a pharmacy.

We need the government to start working on behalf of patients to get this resolved. I can’t just call up the manufacturer of Morphine Sul ER and tell them to make more. It has to be the government that intervenes. 

The best place to start would be to lift the DEA production quotas – although that’s really just a start. If we’re being realistic here, there should also be production minimums, with government funding and support if needed. 

People’s lives depend on these medications. It’s time to stop pretending that these drug shortages are just trivial inconveniences. They’re harmful, and sometimes even deadly.

Where Did the Opioid Settlement Money Go?

By Crystal Lindell

How are states spending their opioid settlement money? Unsurprisingly, it’s often hard to say – even when a state has promised transparency. 

Federal, state and local governments in the United States will collect about $50 billion in opioid settlement money in coming years from basically every sector of the health care industry, including drug makers, wholesale distributors and pharmacies. 

But an investigation of 12 states by NPR and KFF Health News found that it’s unclear how much of that money is being used to prevent addiction or to help people with substance abuse issues. 

As a pain patient, I have long assumed that none of the settlement money would be used to develop effective, non-opioid pain analgesics for patients who lost their medication as a result of opioid-phobia. Based on how everything around opioids has played out over the years, I also didn’t have high hopes for what it would actually get spent on.

The NPR/KFF Health News investigation shows that I was correct to worry. 

“There are no national requirements for jurisdictions to report money spent on opioid remediation,” Aneri Pattani reported.”In states that have not enacted stricter requirements on their own, the public is left in the dark or forced to rely on ad hoc efforts by advocates and journalists to fill the gap.”

Pattani shared a story about the situation in Idaho, where local governments were required to complete a form showing how they spent settlement money and whether it was for an approved purpose. But a process meant to show transparency seemed to do just the opposite. 

“In reality, it reads like this,”said Pattani. “In fiscal year 2023, the city of Chubbuck spent about $39,000 on Section G, Subsection 9. Public Health District No. 6 spent more than $26,000 on Section B, Subsection 2. Cracking that code requires a separate document. And even that provides only broad outlines.”

Pattani said that following the money trail just led to more intentionally confusing bureaucratic language. 

For example, she found that Subsection 9 refers to “school-based or youth-focused programs or strategies that have demonstrated effectiveness in preventing drug misuse.” 

Subsection 2 refers to “the full continuum of care of treatment and recovery services for OUD and any co-occurring SUD/MH conditions.” 

“What does that mean? How exactly are you doing that?” Corey Davis, a project director at the Network for Public Health Law, wondered when he first saw the Idaho reports. Without detailed descriptions of the projects the money was spent on, it’s impossible to track. 

“It’d be similar to saying 20% of your monthly salary goes to food,” Pattani wrote. “But does that mean grocery bills, eating out at restaurants, or hiring a cook?” 

Minnesota’s ‘Dashboard’

Some states are more transparent about where the money is going. Minnesota, for example, has an online dashboard and downloadable spreadsheet listing projects. One project was in Renville County, which used $100,000 to install a body scanner in its jail to help staff find drugs in the body cavities of inmates.

So, cops are getting the money. And when you look around on the Minnesota dashboard, it becomes clear that law enforcement agencies got some of the largest shares of the state’s opioid settlement money.  

So far, Minnesota has received over $74 million in settlement money. Of that, law enforcement-related categories received about $17 million, coming in fourth behind "American Indian" with $32.6 million, “African or African American" with $22.6 million, and "Child protection” which received $22.65 million. 

I was pleasantly surprised to see that Minnesota does have a "Chronic pain patients" category — but then was disappointed to learn that it got the least amount of money of any group, receiving just $290,180 of the state’s settlement funds.

When I drilled down deeper on the chronic pain category, things only got more depressing. 

The bulk of that money ($257,220) went to Hennepin Health System to "expand access to holistic chronic pain treatment through Heals on Wheels program,” which includes traveling clinics that provide training in mindfulness, stress management, mindful movement, acupressure, acupuncture and massage therapy.

The remaining $32,960 went to a group called Health Partners, which said it would use the money to, "Certify 10 clinicians to provide Empowered Relief, a one-session class that equips patients with pain management skills, draws on principals from mindfulness and cognitive behavior therapy.” 

As a pain patient, finding out that the very small amount of Minnesota’s opioid money going to pain patients is being used to fund BS about mindfulness is beyond infuriating. We need real treatments, not happy thoughts.

Of course, in other states, it’s hard to even know how much money is going to cops and if any is going to chronic pain patients, so I guess I should be happy that there’s at least some record of things in Minnesota.  

Interestingly, over $1.9 million of Minnesota’s settlement money went to the Steve Rummler Hope Foundation, primarily for opioid education and naloxone distribution. 

Coincidentally, the Rummler Foundation happens to be the fiscal sponsor of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played an instrumental role in raising fears about opioid use and addiction.

Several PROP members worked as paid expert witnesses for plaintiff law firms that pursued opioid litigation on behalf of the states, and were paid as much as $850 an hour for their services. The law firms themselves will pocket billions of dollars in contingency fees once all the funds are paid. That kind of detail is rarely mentioned in reporting on how settlement money is used.   

So while some details of how opioid funds were spent are technically available to the public, Pattani says it doesn’t matter if finding them requires hours of research and wading through budgetary jargon.

“Not exactly a system friendly to the average person,” she said.

Of course, if any of the opioid settlement money was ever actually meant to help people who may have been harmed by opioids, it wouldn’t be going to governments – it would be going directly to opioid users or their surviving loved ones.

But it’s been clear from the beginning that these opioid settlements were primarily a cash grab for state and local governments, plaintiff law firms, and their expert witnesses. They don’t help patients and they don’t help their loved ones. 

I don’t expect any of the states to increase transparency about where the money has been going. Most of the general public doesn’t care, so the states can funnel a lot of the money into things like body scanners, because they don’t have the pesky public watching what they’re doing. 

Maybe next time when we decide to sue every pharmaceutical company and pharmacy chain in the country, we could at least make it class action lawsuits on behalf of patients, not governments.

Return to Sender: WIll Anyone Use FDA’s New Opioid Mail-Back Program?

By Crystal Lindell

The DEA has been hosting drug “Take Back Days” for over a decade, collecting over 9,200 tons of unwanted or expired prescriptions and over-the-counter medicines. The take-back program is seen as a key effort to prevent drug diversion and opioid addiction.

Now the Food and Drug Administration is expanding its own drug collection program – essentially making every day an opioid take-back day.  

Starting on March 31, 2025, drug makers participating in the FDA’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)  – which means every company that makes and sells opioids – will be required to provide pre-paid, drug mail-back envelopes “upon request” to pharmacies that dispense opioids. The pharmacies then have to give the envelopes to patients and caregivers who ask for them, so they can mail back any unwanted opioids. 

The fact that both pharmacies and patients have to request these envelopes makes me skeptical about how much this program will actually be used.

The press release from the FDA includes a quote that sounds surprisingly pro-patient though. So even if the program doesn’t have a high use-rate, perhaps an extra measure of safety will make it easier for patients to get opioid prescriptions. 

“We want to ensure patients have access to opioid analgesics in their pain management regimens and that they are educated about methods available to safely dispose of any leftover medicines, which could pose a real danger to their loved ones and pets,” said Marta Sokolowska, PhD, deputy center director for Substance Use and Behavioral Health at the FDA Center for Drug Evaluation and Research.  

It’s the part about ensuring that “patients have access to opioid analgesics” that stands out to me. Patients certainly need access to opioid pain meds. And if programs like this help doctors and medical professionals feel more comfortable prescribing opioids, then I fully support them. 

But I’m skeptical about whether that will be the actual outcome. The real question is whether anyone will use the mail-back program. 

The DEA has never released a full breakdown of the medications returned during its drug take-back days. But an analysis of the drugs returned at a take-back day in Lansing, Michigan in 2013 provides some insight. 

Of the nearly 2,500 medication containers that were returned, only 304 were for a controlled substance like opioids – about 12% overall. The most common types of medication returned were for pain/spasm, cardiovascular, and mental health conditions.

While hydrocodone/acetaminophen combinations (Norco) were the most returned medication at that 2013 event, it represented just 4.4% of all returned containers. 

The second most-common drug returned was ibuprofen (Advil) in 2.2% of the containers. Acetaminophen (1.7%) and aspirin (1.3%) also made the top ten list of most-returned medications. 

Something tells me that Advil isn’t what organizers had in mind when they asked people to bring in their unused drugs. 

In the end, the FDA’s new mail-back program will likely have a greater impact as a public relations initiative to make the agency look good, rather than keeping unwanted opioids off the street. 

In a world where doctors are so reluctant to prescribe opioids, I don’t blame people for wanting to hold on to the opioids they’re able to get. In a PNN survey of thousands of pain patients, nearly a third (32%) admitted hoarding their unused opioids because they’re unsure if they’ll be able to get them in the future 

If we’re lucky, the program will accomplish at least one of the goals that the FDA’s Sokolowska laid out: “We want to ensure patients have access to opioid analgesics.”

Given the federal government's abysmal track record with opioids and pain care in general, I’ll believe that when I see it.

Drug Shortages Easing, But Pain Patients Still Have Problems Getting Opioids

By Pat Anson

Shortages of prescription drugs and other medications appear to be easing in the United States, but with tight supplies of oxycodone, hydrocodone and other opioids persisting.

As of September 30, the number of active drug shortages stands at 277, down from a record high of 323 at the end of last year, according to a new report from the American Society of Health-System Pharmacists (ASHP). The report found that shortages of drugs used for pain, anesthesia, chemotherapy and attention-deficit/hyperactivity disorder (ADHD) “continue to be problematic.”

Health systems also face significant shortages of medical grade intravenous (IV) and dialysis fluids, which have gotten worse in recent weeks due to production shortfalls in the southeast caused by Hurricanes Helene and Milton. To conserve supplies, some hospitals are giving patients Gatorade instead of IV electrolytes. The American College of Emergency Physicians also recommends using tap water to clean wounds rather than sterile irrigation fluids.

Over half of the drug manufacturers (60%) contacted by the ASHP did not provide a reason for the shortages, but others cited increased demand for certain drugs (14%), manufacturing problems (12%), business decisions (12%), and raw material shortages (2%).

The ASHP has also cited reduced DEA production quotas and the fallout from opioid litigation settlements, which have significantly reduced the supply of opioid medication and led to rationing at many pharmacies. In a recent PNN survey, 90% of patients with an opioid prescription said they had trouble getting it filled at a pharmacy.

Teva Pharmaceuticals, a large generic drug maker, recently discontinued production of potent fentanyl analgesics known as Transmucosal Immediate-Release Fentanyl Medicines (TIRF). That forced the FDA to end a program that supplied TIRF medication to about 150 patients, many of them suffering severe pain from late-stage cancer.

Teva has not made any public statements about its discontinuation of the TIRF drugs Actiq and Fentora. The most likely explanation for the discontinuation is that Teva’s bottom line was suffering due to the costs of opioid litigation. In 2022, Teva agreed to pay $4.25 billion to settle thousands of opioid liability lawsuits.

Opioids currently listed in short supply by the ASHP include oxycodone/acetaminophen tablets, oxycodone immediate-release tablets, hydrocodone/acetaminophen tablets, hydromorphone tablets and solution, fentanyl patches, fentanyl solution, and morphine solution. Most have been in shortage for over a year.

‘It’s So Hard to Find My Medications’

The Drug Enforcement Administration recently announced plans to further reduce the supply of prescription opioids in 2025, while raising production quotas for amphetamine and other stimulants used to treat ADHD.

Although the FDA advised the DEA that medical need for schedule II opioids will decline 6.6% next year, DEA is proposing only minor reductions in the supply of fentanyl, oxycodone, hydrocodone and hydromorphone, while keeping quotas unchanged for morphine and codeine. If the quotas are implemented, it would be the ninth consecutive year the opioid supply has been reduced.

Over 1,900 people submitted comments to the Federal Register on the DEA’s plans, many expressing frustration with chronic opioid shortages.

“It’s so hard to even find my medication anymore. I have to go from pharmacy to pharmacy and it causes so much anxiety. I feel so insecure and the unknown makes me sick,” wrote Sierra Shareiko. “It’s like kicking us down while we’re already down. We need to start being smart and looking into how much these medications are actually keeping us alive.”

“In the last year I have had to contact multiple pharmacies in order to get my monthly refill of opioid medication I take for a chronic disease I’ve dealt with for 16 years. Either the pharmacies are out of stock, or they will only fill prescriptions for acute pain,” said another patient. “By throttling production, you’re throwing an already precarious situation further into chaos. You’re putting pressure and stress on the entire medical system and it’s not solving any problems.”

One letter, signed by over two dozen geriatric and palliative care physicians in New York City, warned that any further cuts in the opioid supply would “cause significant harm” to patients.

“In my clinical experience, virtually every time we prescribe opioids for severe and disabling pain in the setting of serious illness, we are required to spend hours tracking down a pharmacy that has the medication in stock. Most do not because their suppliers can't get it for them,” wrote Dr. Diana Meier.

“Our inability to care effectively for our patients because of well-intended but harmful constraints on production and distribution of opioid analgesics is a major source of burn out, frustration, and anger among the already inadequate workforce available to care for the mostly older people living with serious and chronic illness.”

“As a recently retired pain doctor, I saw firsthand just how difficult opiate supply cutbacks made life for my patients. Some reported calling 20 or 30 pharmacies, or traveling a hundred miles, to find pharmacies that would fill their prescriptions,” said Dr. William Taylor. “These cutbacks are a backdoor way to deny medication to patients who have a legitimate medical need for opiate analgesics. There is no evidence that these cutbacks benefit patients in any way.”

The public comment period on the DEA’s proposed 2025 production quotas has ended. The agency is expected to release its final decision on drug quotas before the end of the year.

Opioids Are Effective at Treating Pain. Just Ask My Family

By Crystal Lindell

What if I told you that there was a medication that made it possible for my grandma to live at home instead of a nursing home? 

And that the same medication allowed my uncle to endure prostate cancer treatments long enough to see his cancer go into remission. And that it helped my mom avoid pneumonia after hip surgery. Or that this medication is the only reason I’m pain-free enough to be able to write this column?

But that’s not all. What if I told you the same medication helps me take care of my cats, as well as the cats at the local animal shelter where I volunteer? 

What if I told you that doctors hated this medication? And that many of them also hate anyone who takes it?.

In an age of opioid-phobia, it seems a lot of people – doctors in particular – have forgotten why opioid pain medications like Norco exist in the first place. And why they are such a miracle drug.

Over the summer, my grandma fractured her foot. After a couple of weeks in the hospital, she was transferred to a rehab facility to start the healing process. In mid-October, she was finally cleared to put some weight on her foot again, and last week she was able to come home. 

But she’s still not fully recovered and every movement still feels like climbing a mountain. In fact, standing up to go from her chair to the commode would still be impossible for her, if not for one very specific medical intervention: a 5mg hydrocodone tablet.

Yes, just one of those pills every six hours makes it possible for her to stand up to use the bathroom, walk to the kitchen, and visit with her new great-grandchild. 

Too bad her doctors are doing everything possible to refuse to prescribe it for her. Each one keeps pushing her off to a different specialist that they claim should actually be giving them to her.

The entire situation is made all the more frustrating because her chronic health issues mean she’s not allowed to take the pain medication most doctors try to push on patients: ibuprofen. 

Not to mention the fact that – at 82 years old – the main reason that doctors cite for refusing to prescribe opioids to my grandma doesn’t apply. At her age, she’s not likely to suddenly develop compulsive use behavior. And if she did, why would it matter? 

Doctors will sometimes claim that opioids aren’t effective at treating pain long term. But if a patient says they are still effective, then clearly that doesn’t apply.

Here we are in 2024, and we as a civilization have managed to harness the power of the poppy plant to such an extent that we can use it to help elderly patients enjoy their final years at home with loved ones, instead of being stuck in a depressing nursing home. But we refuse to use it. 

I’m tired of having to spend so much time countering people who think opioid pain medications are the root of all of society’s ills. That’s just not the case. Unfortunately, their constant complaints have managed to work the refs, so now we have to waste time begging for the bare minimum in pain treatment. 

In fact, if those same people would just look around a little bit, they would see the truth: opioids help millions of people lead better lives. And, if anything, they should be prescribed more, not less. 

Benzodiazepines Get Positive Reviews on Twitter

By Pat Anson

Benzodiazepines have gotten a bad reputation over the last few years. The anti-anxiety medications were once commonly prescribed to pain patients, until fears rose that Valium, Xanax and other benzodiazepines could lead to an overdose when taken with opioid medication.

In 2016, the FDA warned of a “public health crisis” because overdose deaths involving opioids and benzodiazepines had nearly tripled. That was followed in 2020 by updated FDA warning labels that strongly cautioned patients and doctors about the risks of benzodiazepine abuse, addiction and dependence.

It turns those public health messages have fallen flat, because many patients have entirely different attitudes about benzodiazepines. In an unusual study of social media posts on Twitter (now known as “X”), researchers found that over half the tweets praised how effective benzodiazepines are, with minimal discussion of their side effects.

“Social media platforms offer valuable insights into users’ experiences and opinions regarding medications. Notably, the sentiment towards benzodiazepines is predominantly positive, with users viewing them as effective while rarely mentioning side effects,” wrote lead author Óscar Fraile-Martínez, an academic researcher at the University of Alcalá in Spain.

Fraile-Martínez and his colleagues analyzed over 11,600 English-language tweets that mentioned benzodiazepines in 2019 or 2020. Zolpidem (Ambien), lorazepam (Ativan), and clonazepam (Klonopin) were the most frequently discussed medications.

Over half the tweets (57%) were posted by patients or their relatives, while healthcare professionals authored less than 1% of them. The remaining tweets were posted by other users who couldn’t be classified.

The study findings, published in BMC Psychiatry, show that only about 5% of the tweets discussed adverse side effects from benzodiazepines, such as daytime sleepiness, impaired cognitive functioning, memory problems, reduced mobility, and increased risk of falls and fractures.

Notably, a significant percentage of patients reported combining benzodiazepines with other psychiatric drugs, or with alcohol and other addictive substances. Yet there was hardly any discussion of overdoses, dependence or withdrawal.

Researchers say the minimal discussion of side effects may be due to the nature of social media, where posts tend to be shorter and provide little detailed medical information.  

“The predominance of positive mentions about benzodiazepines’ efficacy on Twitter could be due to several factors. Users may share personal experiences that highlight immediate relief from anxiety and insomnia, which are the primary benefits of these medications. This focus on short-term effectiveness may occur because individuals seek validation and support for their experiences or advice on similar issues, thus emphasizing positive outcomes,” wrote Fraile-Martínez. 

So who is right? Twitter users with positive views about benzodiazepines or public health experts who think the medications are potentially dangerous?    

The researchers in this study took the latter view. They say their findings show “an alarming minimization” of the risks associated with benzodiazepines and called for expanded efforts to educate physicians, patients, and families about their use.

Doctors who heed that advice may want to think twice about tapering patients on long-term benzodiazepine treatment. A recent study found that cutting off or rapidly tapering patients on benzodiazepines nearly doubles their risk of dying within a year. Deaths from suicide, accidents and other causes rose for patients after benzodiazepines were discontinued.

Can ‘Abuse-Deterrent’ Oxycodone Help Calm Fears About Opioids?

By Crystal Lindell

When I first saw the news about an “abuse-deterrent” formulation of oxycodone being approved by the FDA, I was skeptical. What exactly was sacrificed to be worthy of such a claim? 

However, after reading more about it, I am here to report that RoxyBond — which is made by Protega Pharmaceuticals — could be the opioid medication that pain patients have been waiting for. In a perfect world, RoxyBond won’t just treat pain, it may also help calm fears about opioid addiction and overdoses. 

RoxyBond is not new. It’s already available in 5mg, 15mg and 30mg tablets. What the FDA did was approve a new 10mg tablet, making it the first immediate-release opioid of that dosage with abuse-deterrent properties. Most abuse deterrent opioids are extended-release medications.

“Abuse-deterrent” essentially means the tablets are so hard they cannot easily be crushed or dissolved in order to snort or inject them for a quick high. In the case of RoxyBond, that’s due to special coating and chemical make-up called SentryBond.

Protega describes SentryBond as “technology [that] combines inactive excipients with active pharmaceutical ingredients to make the tablet more difficult to manipulate for misuse and abuse.” 

The noteworthy part for patients is that SentryBond makes the medication harder to abuse without the use of an opioid antagonist like naloxone. In other words, RoxyBond does not contain what a lay person may call an opioid antidote. That’s good news because naloxone can make opioids less effective and can distort a patient’s tolerance levels. 

Protega says RoxyBond’s formulation is “expected to reduce abuse by intranasal and intravenous routes,” but there is also an interesting caveat in their press release. 

An asterisk points readers to this disclaimer: "Abuse is still possible by intranasal, intravenous, and oral routes." That’s what previous studies have found about pills that are hardened as an abuse deterrent, so I’m not sure if RoxyBond will actually prevent abuse.

And, to be honest, that’s not what I’m concerned about. I’m much more interested in how the medication’s “abuse-deterrent” descriptor will impact prescribers and the DEA. Perhaps it’s naive of me, but my hope is that doctors and nurses will see those magic adjectives and feel more comfortable about prescribing opioids. 

And — while this is perhaps even more naive — the best outcome would be for the DEA to see RoxyBond as a “safe” pain medication. 

Years ago, the FDA put out a call for companies to develop abuse-deterrent opioid medications just like Roxbody, writing:

“The FDA looks forward to a future in which most or all opioid medications are available in formulations that are less susceptible to abuse than the formulations that are on the market today. To achieve this goal, FDA is taking steps to incentivize and support the development of opioid medications with progressively better abuse-deterrent properties.”

The fact that the FDA has now approved multiple doses of RoxyBond, and that the medication was basically made at the request of the government, gives me some hope that the DEA will see the tablets as less dangerous than other opioids and won’t target doctors who prescribe it.

If doctors and the DEA need adjectives like “abuse-deterrent” in order to feel safe treating pain, then that’s a small price for patients to pay. Especially since it sounds like RoxyBond is just as effective as other opioids when it comes to treating pain. 

Protega says SentryBond “could potentially be utilized in other medications” like hydromorphone and hydrocodone, so we may be seeing its use expanded.

An interesting side note about SentryBond technology is that it was originally developed in a partnership with Daiichi Sankyo. But the Japanese drug maker walked away from its $200 million investment because it feared becoming entangled in U.S. opioid litigation. That’s how much litigation has disrupted American pain care.

Of course, there is still one glaring problem here. RoxyBond has already been approved in different doses, but it’s not widely known and there doesn’t seem to be much interest from doctors. I have helped multiple elderly relatives navigate their healthcare over the last few years, and I have never once heard a doctor mention RoxyBond as an option for pain management. 

Maybe the news of a new dose being approved will help make prescribers more aware of RoxyBond. Maybe it just needs more time on the market. 

Unfortunately, for many patients in pain, time is not something we have a lot of. We need effective treatments today, because many of us don’t know how we’ll get through tomorrow.