A Fentanyl Vaccine Is a Horrible Idea

By Crystal Lindell

A few years ago, I saved a loved one’s life when he was overdosing on fentanyl.

His lips and fingertips were blue when I found him, and as I administered NARCAN (naloxone), all I could think at that moment was that if he was dead, I never got the chance to say good-bye.

It was one of the most traumatizing experiences of my life, and I’m forever grateful that my efforts to save him were successful.

Even with that experience, I’m here to tell you that a fentanyl vaccine is an absolutely horrible idea. And I pray that nobody I love ever takes it – even the man who’s life I saved.

This week, JAMA published an article about the current status of the fentanyl vaccine, which is in development.

In the article, Associate Managing Editor Kate Schweitzer interviews Collin Gage, a cofounder and chief executive officer of ARMR Sciences, which has begun early-phase human trials of a fentanyl vaccine in the Netherlands.

Schweitzer seems to think such a vaccine would be a net positive for the world.

"If proven safe and effective, it could become the first proactive pharmaceutical approach designed to prevent fentanyl overdose and, potentially, treat addiction," she writes.

However, as both a chronic pain sufferer and someone whose loved one struggled with fentanyl addiction, I’m here to tell you that this entire research project should be ended right now.  

First and foremost, my biggest concern is that such a vaccine would be pushed onto people who do not want or need it, including pain patients.

I can already see doctors having a policy where they won’t prescribe opioids unless the patient agrees to receive the fentanyl vaccine. They’ll claim the policy is meant to protect patients, when in reality, it would only cause them more harm.

The article even points out what those harms could look like. Schweitzer quotes Kathryn Frietze, PhD, associate professor of molecular genetics and microbiology at the University of New Mexico, who is one of many researchers working to develop vaccines against drugs of abuse.

Doctors, according to Frietze, have expressed concern about how a vaccine could complicate medical care, given that prescription fentanyl is a widely used medication for acute pain control and anesthesia.

“Can they increase the fentanyl dose medically if needed, or is it going to completely eliminate fentanyl as an option?” Fritze asked. 

Read that again. Do we really want to eliminate fentanyl as an option for pain control and anesthesia? This is a medication used in hospitals, usually on patients in severe trauma or undergoing surgery.

Do we really want a vaccine to make fentanyl ineffective for them? 

Do we really want a vaccine that requires more fentanyl to be administered?

In practice, either scenario could be disastrous, especially in an emergency situation where an unconscious patient would be unable to explain to doctors that they had the fentanyl vaccine.

The thing about fentanyl is that you have no idea that you might need it someday. We don’t usually know when we’ll need anesthesia or acute pain control.

That is particularly relevant in this situation, because the article quotes multiple experts who seem excited about pushing a fentanyl vaccine onto high-risk groups, such as college students and young adults, who are experimenting with drugs. They may not be aware that the counterfeit pill they bought or got from a friend has a lethal dose of fentanyl. 

“Overdose from fentanyl doesn’t just happen to people who are purposely taking fentanyl,” Frietze said. “People may be exposed without their knowledge.” 

So they want to go to college campuses and give students a vaccine against a very valid pain medication, when they have no idea if they will ever need it?

Schweitzer says a vaccine that specifically targets fentanyl could still allow for the use of other analgesics, such as morphine and propofol. 

As a pain patient, I’m skeptical about that. If a vaccine blocks the effects of one opioid, it may also dampen the effects of other ones.  

The other major issue with a potential fentanyl vaccine is a phrase coined by Richard Cowan in 1986: “The Iron Law of Prohibition.” That essentially means that when law enforcement targets a specific drug, the potency of other prohibited substances increases.

Or, as Cowan said, "The harder the enforcement, the harder the drugs."

If you give everyone fentanyl vaccines, people will just find even stronger drugs to take. And those drugs will likely be more deadly. It’s no coincidence that illicit fentanyl arrived on the black market just as opioid pain medication became harder to get. 

As such, a fentanyl vaccine could result in more overdose deaths, not less, as people seek substitute drugs that bypass the vaccine.

Gage’s response to that possibility is to call the fentanyl vaccine “a platform technology—one that we plan to adapt."

In other words, they will just make new vaccines for new drugs. But in practice, how long would it take to actually develop new ones? And how long would it take to get them to drug users, who are often difficult for the medical community to reach?

Trust me when I tell you that drug users and their dealers will move exponentially faster than any research and development team ever could.

In practice, the reason street fentanyl is so deadly is because it’s unregulated. Users don’t know how much they are taking or what is mixed in with it – and those two things make it more likely that the drug will cause an overdose.

The solution then is to offer drug users a regulated supply, which is what methadone treatment is. In a perfect world, if they really wanted to help fentanyl users, these researchers would be working to make methadone treatment more accessible.

Instead, they’d rather make it so patients can’t use one of the most effective pain and anesthesia medications on the market, while pushing them onto harder or less effective drugs.

It’s a bad idea, and I hope these researchers see the error of their ways before it’s too late.

Tell Me Who the Real Criminals Are

By Cathy Kean 

Close your eyes. Go back to the worst pain you have ever known. A broken bone. A car wreck. Surgery. Childbirth without relief. Stay there for fifteen seconds. 

Feel the desperation. The begging. The need for it to stop.

Now imagine never leaving that place. You feel that pain every second. Every day. No break. Not in sleep. Not ever.

That is my life. Millions of us live here.

There is something that helps. Prescription opioids do not erase my pain, but they turn down the volume enough for me to be able to shower. To work. To keep my home. To hug my grand child without screaming inside.

Then they took them away. They said it was for my own good.

Before my chronic pain worsened after the release of the CDC opioid guideline, I worked as a real estate agent and special education advocate. 

Now I cannot walk. I have lost my job. My home of 32 years is in foreclosure. Friends stopped calling. I need help to use the bathroom. My independence is a corpse they are still kicking.

And the final cruelty? The people who did this lied to you.

CATHY KEAN

The Lies Behind the ‘Opioid Crisis’

You have been told prescription opioids are killing America. In 2021, the CDC reported a 1,040% increase in overdose deaths involving synthetic opioids from 2013 to 2019. They said those deaths were largely caused by illicitly manufactured fentanyl.

Here is what they didn’t tell you in that report: For many years, CDC misclassified most of those overdoses as prescription opioid deaths, and those deaths were used to help justify the agency’s 2016 opioid guideline, which led to wholesale restrictions on opioid prescribing. 

Not until 2018 was the error quietly acknowledged by four CDC researchers. And that tens of thousands of illicit fentanyl deaths were misclassified for years as prescription opioid deaths. 

The error was so serious that in 2016 alone, over 15,000 deaths caused by illicit fentanyl were mistakenly attributed to prescription opioids. Millions of Americans were misled by these and other errors that inflated the overdose numbers.

The White House told you prescription painkillers were the enemy. The media screamed it. Meanwhile, the real causes – illicit fentanyl, heroin and methadone – were hidden inside the CDC's overdose numbers.

The Death Toll They Won't Count

Because of the CDC guideline, thousands of chronic pain patients killed themselves. 

Not because they wanted to die, but because they could no longer get the prescription opioids that made life bearable. The pain became more than they could endure. And suicide offered a way out.

Others died slowly. From heart failure. Stroke. Organ collapse. The brutal physics of untreated pain grinding a body into dust.

No one in power keeps track of those deaths or says a word about them. No government agency. No major news outlet. No one with a microphone stands up and says, "We made a mistake. We are killing innocent people."

Instead, they push Suboxone and “alternative treatments.” For money. Not thy fellow man.

We have lost our First Amendment rights in the doctor's office. If you speak up about your pain, you are labeled a drug seeker and abandoned as a patient. I would rather die at home than face contempt again in the ER.

What I Want You to Do

Now imagine those 15 seconds of the worst pain you’ve ever felt. Really do them. Feel that pain.

Could you live like that? For one week? One year?

I am not asking for your pity. I am demanding your understanding. Your voice. Your outrage.

We are not criminals. We are not drug seekers. We are not addicts. We are not statistics on a CDC spreadsheet.

We are mothers and fathers. Veterans who served you. Construction workers who built your cities. Nurses who held your hand. Grandparents who babysat your children.

And we are dying. Some by suicide. And some by the slow, grinding destruction of our lives and bodies.

So here is what I need from you:

Do not look away. Say our names. Help us get our lives back.

Because if you could spend fifteen seconds in my body — really spent them — you would not need to be asked twice. You would be screaming with us.

Cathy Kean lives in California. She is a grandmother of 9 and mother of 4. Cathy lives with intractable pain from a botched surgery, along with fibromyalgia, arachnoiditis, stiff person syndrome, lupus, Parkinson's disease and insomnia. 

Cathy is the creator and administrator of the Facebook pages Chronic Illness Awareness and Advocacy Coalition and Pain is Pain. She writes to give a voice to the millions of chronic pain patients who have been silenced, stigmatized, and left to suffer—and to ensure her grandchildren never have to ask why Grandma couldn't be there. 

CBD Enhances Oxycodone’s Pain Relieving Effects

By Pat Anson

Some pain sufferers firmly believe that cannabis can help boost the pain relieving effects of prescription opioids. The evidence behind that belief is mostly anecdotal, but some new research lends some credence to it.

In studies on laboratory rats, researchers at the University of Florida and Texas A&M University College of Dentistry found that cannabidiol (CBD) appeared to enhance the pain-relieving effects of oxycodone without increasing the risk of addiction. 

CBD is one of the many cannabinoids found in cannabis. It does not have the same psychoactive effects of tetrahydrocannabinol (THC), but is believed to have some therapeutic benefits.

The rats were treated with CBD, oxycodone or a combination of the two daily for two weeks, while acute pain was induced in the laboratory.

The study findings, published in The Journal of Pain, found that CBD enhanced oxycodone’s antinociceptive effect, meaning it blocked pain signals from reaching sensory neurons in the brain. CBD also did not affect the “rearing behavior” or “place preference” of rats, activities that may have suggested they were becoming dependent or addicted to oxycodone.

“Together, these findings suggest that cannabidiol potentiates the analgesic effects of oxycodone without affecting its reward-related properties. These results support the potential of cannabidiol as an adjunctive, opioid-sparing agent in pain management,” researchers wrote.

A recent study of 21 people with knee osteoarthritis reached a very different conclusion, finding that a low-dose of opioids taken with a cannabis-based medicine did not relieve acute pain. 

That study, however, was deeply flawed. The cannabis-based medicine was dronabinol (Marinol), a synthetic version of THC. Dronabil is FDA-approved to treat nausea and improve appetite, but is not intended to provide pain relief. The medication also has little in common with the various forms of cannabis (edibles, smoking, vaping) used in the real world.  

Granted, the use of dronabil and laboratory rats are major weaknesses in both studies, which highlights how cannabis research has long been stifled in the U.S. by marijuana’s status as an illegal Schedule I controlled substance.     

The DEA is now allowing more cannabis to be used for research purposes and recently reclassified medical marijuana as a Schedule III drug, which allows for medical uses. It could be years, however, before we see more high-quality studies about the risks and benefits of cannabis products.  

A Simple Chart Destroys a Myth About the Opioid Crisis

By Neen Monty

There’s a simple reason the narrative around the “opioid crisis” falls apart when you actually look at the overdose data.

Because the data doesn’t show what they claim it shows. 

And that false narrative has been retrofitted to cover the deception and lies wrought by bad actors in the U.S. healthcare system.

The chart below tracking overdose deaths by opioid type tells two stories:

1. Prescription opioid deaths rose, stabilized, and then fell.

2. Fentanyl arrived… and everything exploded.

Those are not the same curve. Those are not the same problem.

There are two epidemics. And one deliberately blurred narrative.

In the United States, prescription opioid deaths peaked around 2012, at about 5 deaths per 100,000 Americans. 

Meanwhile, fentanyl-related deaths – almost non-existent before 2012 – began rising exponentially as illicit fentanyl entered the black market.

In 2023, they peaked at 22.2 deaths per 100,000 people. By then, overdoses linked to prescription opioids had fallen to 3.8 deaths per 100,000.

That means there are almost 6 times the number of overdose deaths caused by illicit fentanyl than prescription opioids.

Yet prescription opioids remain the target.

That “opioid crisis” curve?

That’s illicit fentanyl. Not pain patients. Not prescription opioids. Not doctors treating disease.

The Uncomfortable Truth

When overdose deaths skyrocketed, prescription opioid deaths were already flattening out and falling. That should have changed the narrative right there.

But the narrative stayed the same.

The explosion in deaths aligns with one thing: iIlicit fentanyl and its analogues flooded the U.S. drug supply with counterfeit pills of unknown, often lethal, potency.

That is why deaths surged, not because someone with intractable rheumatoid arthritis got oxycodone prescribed for their pain.

The numbers don’t lie. If the opioid crisis were really about prescriptions, the lines on the chart would look very different.

So why didn’t the narrative charge?

Because blaming illicit fentanyl means:

• Confronting illicit drug supply chains

• Admitting policy failure

• Acknowledging complexity

Blaming prescriptions is easier. It creates easy villains to target:

• Doctors

• Patients

• Pain medication

And it opens the door to:

• Restrictions

• Guidelines

• “Education programs”

• Entire industries built on fear

Who paid the price?

Pain patients. People with cancer, autoimmune disease, neurological damage, and severe structural pathology.

People who were stable. Functioning. Living.

Until they were cut off.

This was never about prescriptions. The chart makes one thing brutally clear: The U.S. overdose crisis is a fentanyl crisis.

Everything else is a false narrative. A fairy story. One designed to vilify people who are already among the most vulnerable people in our communities – the ill, the disabled, people living with severe pain.

It’s important to note that by the time Physicians for Responsible Opioid Prescribing (PROP) was created in 2012, prescription opioid deaths had already stabilised and were falling.

PROP was instrumental in creating the CDC’s infamous 2016 opioid prescribing guidelines. But there was no need to restrict opioid prescribing. There was no need for forced tapers that lead to suicides and overdose deaths. There was no need for dose ceilings that meant people’s pain was no longer treated adequately.

There was also no need for the fabrication of “evidence” that does not stand up to even a little scrutiny. Just read the studies that the CDC guidelines are based on. They do not show what you have been told they show.

But no one actually reads the studies. No one examines the data. No one questions. Doctors just blindly follow the guidelines. It’s hard to blame them when they face prison time if they don’t.

It has been ten years since the forced tapers started in the U.S. Six years since Australia blindly copied this failed policy. No one in Australia bothered to read the research. Australia just copied the U.S. guideline and allowed politicians to decide who gets pain relief and who does not.

Australia could see the policy going horribly wrong in the U.S. Yet it implemented those same policies and tortured Australian chronic pain patients the same way. The same is true for Canada and the UK as well.

This should never have happened.

Patients on three continents have been abandoned, left to suffer in agony day after day. Given psychological therapies for physical disease and injury. And no one says a word. 

I have contacted many politicians, journalists, and senior public servants in Australia.  No one will take this on. No one will right this wrong.

And the media continues to push a false narrative about an opioid crisis that does not exist. But it gets clicks.

It may be futile, but my life and those of many others depend on access to safe and effective opioid therapy.

And so, I will continue to fight.

Neen Monty is a patient advocate in Australia who lives with rheumatoid arthritis and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a progressive neurological disease that attacks the nerves.

Neen is dedicated to challenging misinformation and promoting access to safe, effective pain relief. For more information on chronic pain, the science, the politics and the lived experience, go to Pain Patient Advocacy Australia. You can also subscribe to Neen’s free newsletter on Substack: “Arthritic Chick on Chronic Pain.”

CYP2D6: The Enzyme That Determines How Effective an Opioid Is

By Dipa Kamdar

For a medicine so commonly found in bathroom cabinets and high street pharmacies, codeine has a surprisingly complicated story. It sits at the intersection of pain relief, genetics, public health and regulation. 

As the UK and other countries continue to tighten rules around opioid use, codeine offers a useful case study in how a drug can be both helpful and potentially harmful, depending on who takes it and how it is used.

Codeine is an opioid used to treat mild to moderate pain. In some formulations, it is also used to suppress coughing. Over-the-counter products typically combine it with paracetamol, as in co-codamol, or ibuprofen, while stronger doses are available only on prescription.

Codeine itself is a weak opioid. Its analgesic effect is about one tenth that of morphine. Once swallowed, it is metabolised by enzymes in the liver, with some of it converted into morphine. That morphine then produces pain relief by acting on opioid receptors in the brain. 

For most people, the body makes enough morphine to ease symptoms. For others, the same dose can be ineffective or unexpectedly strong.

Fast vs Poor Metabolisers

One of the most striking features of codeine is how differently people process it. The enzyme mainly responsible for converting codeine into morphine, CYP2D6, varies significantly between people. Most metabolise codeine at an expected rate, but some carry genetic variants that alter the process.

A small proportion of the population are ultra-rapid metabolisers, thought to make up around 1% to 2% of people. They convert codeine into morphine much faster than average. 

This trait is more common among people of North African and Middle Eastern backgrounds, for whom even standard doses can produce unexpectedly high morphine levels, increasing the risk of severe drowsiness, breathing difficulties and other serious side effects.

Around 2% to 11% of people are intermediate metabolisers. Their CYP2D6 enzyme works more slowly or less effectively, so codeine may provide only limited benefit.

At the other end of the spectrum are poor metabolisers, estimated to make up 5% to 10% of the population. They convert very little codeine into morphine, so the drug may offer little or no pain relief. 

Poor metabolism is more common in people of white European descent. In these cases, it may make more sense to prescribe a different painkiller rather than rely on a drug the body cannot use efficiently. This wide variation makes codeine far less predictable than many people assume.

The Trouble With Codeine

That unpredictability matters because low-dose codeine does not always offer much in return. Research suggests that many over-the-counter codeine products provide little proven benefit for pain relief, particularly at doses below 10mg, while still carrying the risk of side effects. 

A review found that low-dose codeine combinations gave only modest relief for short-term pain, such as dental pain, episiotomy pain or pain after minor surgery, and many of the underlying trials were small.

By contrast, combinations such as ibuprofen 400mg with higher-dose codeine, between 25mg and 60mg, appear to provide more reliable relief. Even so, studies suggest that simple combinations such as paracetamol plus ibuprofen can match or outperform low-dose codeine products without the risks associated with opioids.

Common side effects include constipation, nausea, dizziness and drowsiness. At higher doses, codeine can slow breathing and impair coordination. It can also interact with other medicines that cause sedation, including some antiepileptic drugs. Certain antidepressants can block the enzyme that converts codeine into morphine, making it less effective.

Like other opioids, codeine can also become less effective with repeated use. This process, known as tolerance, happens when the brain’s opioid receptors adapt to the drug. People may then need higher doses to achieve the same effect. Even when taken as directed, tolerance can develop within days, and as doses rise, so does the risk of physical dependence.

Stopping suddenly after regular use can trigger withdrawal symptoms such as restlessness, sweating, anxiety and poor sleep. This is why health professionals advise using codeine for the shortest possible time and tapering the dose if it has been taken for longer periods.

Concerns about misuse, addiction and accidental harm have prompted tighter regulation in the UK. The Medicines and Healthcare products Regulatory Agency has introduced clearer warnings on packaging about addiction risk and limited over-the-counter pack sizes to a maximum of 32 tablets or capsules. Non-prescription codeine-containing products are now intended for use for no more than three days. Stronger codeine tablets, including 30mg formulations, have long been prescription-only.

Some products have faced even stricter controls. Codeine linctus, once widely used as a cough suppressant, was reclassified as prescription-only in 2023 because of growing concerns about misuse and diversion. 

It has been used in “purple drank”, a recreational mixture of codeine cough syrup with soft drinks and sometimes alcohol. Its opioid effects can lead to dependence, breathing difficulties and overdose, especially when combined with other sedatives.

Codeine remains a useful option for short-term pain when other medicines are unsuitable or insufficient. But its effectiveness, safety and potential for dependence vary far more than many people realise.

In a landscape where medicines are often judged by how familiar they feel, codeine is a reminder that common does not always mean simple. Used carefully, it can help. Used carelessly, it can cause problems that last long after the pain itself has passed.

Dipa Kamdar is a Senior Lecturer in Pharmacy Practice at Kingston University.

This article originally appeared in The Conversation and is republished with permission. 

Many Rx Opioids – Not Just Suboxone – Raise Risk of Dental Disease

By Pat Anson

Suboxone isn’t the only opioid medication linked with dental decay and disease.

A large study led by VA Connecticut researchers found that patients on long-term opioid therapy with pain medications such as morphine and oxycodone have a significantly higher risk of infection-related dental disease.

The observational study included data from over 2 million U.S. veterans, 36% of whom were on long-term opioid therapy (LTOT). Those taking opioid pain medication for at least 90 days had a 24% higher chance of tooth decay, infections or tooth loss. 

Suboxone, which contains the partial opioid agonist buprenorphine, was excluded from the study, along with the opioid methadone. Both medications are used to treat opioid use disorder (OUD). 

The FDA warned in 2002 that buprenorphine tablets and film, when dissolved in the mouth, were linked to serious dental problems, including tooth decay, cavities, oral infections, and loss of teeth. Methadone has also been associated with dental problems because it induces dry mouth (xerostomia), which reduces saliva needed to wash away bacteria and plaque.  

The new study is believed to be the first linking dental disease to opioids taken long-term for pain relief.

“To our knowledge, this is the first study to demonstrate the association between LTOT exposure and dental disease. This finding is important in light of recent warnings of buprenorphine risks that may influence decision-making in the context of chronic pain and/or OUD,” researchers reported in the journal PLOS One.

In their analysis, VA researchers compared veterans who took 12 opioids (hydrocodone, oxycodone, morphine, fentanyl, hydromorphone, dihydrocodeine, meperidine, pentazocine, propoxyphene, levorphanol, tramadol, or tapentadol) to veterans who had no exposure to LTOT in the prior year.

Researchers think the higher rate of dental disease for those on LTOT stems from immune suppression and reduced saliva flow, which raises the risk of bacterial infections that lead to dental disease and cavities. 

The findings suggest that all patients on LTOT – whether for pain relief or OUD treatment – should be cautioned about the risks of dental problems.

“Concern over these risks may present a barrier to buprenorphine initiation in patients prescribed LTOT for whom such treatment is indicated. However, full opioid agonists themselves may pose oral health risks due to immunosuppression and well-documented effects on saliva flow causing xerostomia; both create opportunity for oral disease development,” researchers concluded.

Doctors who have patients on LTOT are advised to monitor their oral health and to have discussions with patients about dental risks before starting them on opioids.

There are simple steps patients on long-term opioids can take to reduce their risk of dental disease. Patients on buprenorphine or methadone are often advised to drink more water to combat dry mouth, and to brush and floss regularly to help prevent dental infections. 

The Fake Excuses Pharmacists Use to Avoid Filling Opioid Prescriptions

By Crystal Lindell

I still remember the first time a pharmacist lied to me about why they couldn’t fill my opioid prescription.

I went in to pick up my regularly scheduled morphine refill, and when I got to the counter, she told me that my insurance wouldn’t cover two prescription refills within the same calendar month. She claimed that the rule applied even if the refills were 30 days apart due to a month having 31 days. And, since the insurance wouldn’t cover it, they weren’t filling it.

At the time, it didn’t even occur to me that a pharmacist would blatantly lie to me about something like that. So I immediately walked away from the counter and pulled out my cell phone to call my insurance company.

I’m not going to lie, I had a whole rant ready to spew at them about this nonsensical rule.

As it turned out, my frustration was misplaced, because no such nonsensical rule existed. In fact, the representative told me no one from the pharmacy had attempted to even put the prescription through. If they had, the insurance company would have covered it.

When I went back to the pharmacy counter and relayed this information, the pharmacist shrugged and said it must have been a mistake. Then, she filled my prescription – which was indeed covered by insurance.  

It wouldn’t be the last time I would have to deal with a lying pharmacist.

Over the years I’ve realized that it’s common for pharmacists to throw up false hurdles when patients try to fill any type of controlled substance script. This includes opioids, but also stimulants like those prescribed for ADHD.

I’ve seen it happen many times to myself and loved ones. Their excuses seem to fall into three broad categories.

Claim #1: Insurance won’t cover the medication

This ties into my opening story here, but it’s also happened to me and my loved ones a number of other times.

For example, after my mom had a hip replacement surgery, the pharmacist tried to tell her that her insurance would only cover a specific number of pills, so they did not fill for the entire amount. My mom was too out of it to argue with them and just accepted the smaller amount – which is what the pharmacist was likely hoping would happen.

A related claim here is that the pharmacy can’t take cash payment for a controlled substance in cases where insurance is refusing to cover it. They never even offer the option in this circumstance, despite the fact that generic pain medications are relatively cheap, and many patients would be happy to pay cash if it meant getting their meds.

I can only speak to Illinois, but as someone who’s been living without health insurance since 2022, I can confirm that pharmacies here can definitely take cash for a controlled substance.

Claim #2: The pharmacy never received the prescription from your doctor

Just last week, one of my loved ones called his pharmacy when his pain medication was due to be refilled and the staff told him that they had not received the prescription. He asked them to check different computer files to see if they were missing it, because he was sure his doctor had sent it in.

The pharmacy staff insisted that they had not received it. It was a Saturday, so he was unable to get a hold of his doctor.

He called back on Sunday morning and they again claimed they had not received the prescription, but after he pushed them to look for it in different places they suddenly found it.

When he finally got the bottle, it said the prescription had been dated for that Saturday, meaning they had definitely lied about not receiving it the day before.  

Claim #3: The medication is completely out of stock

This is one that’s difficult to prove, but it happens so frequently that I have to assume that at least some of the time pharmacists are lying about being out of a medication. It’s an excuse they can give to avoid filling a prescription. 

Even if they aren’t lying about it, there’s nothing the patient can do to prove it. Opioids at many pharmacy chains are essentially being rationed due to opioid litigation settlements.

Beyond the direct lies, pharmacists use other tactics to make getting refills more uncomfortable and difficult. I assume that their hope is that it will deter patients from coming back.

For example, my current pharmacist will sometimes decide that he needs to discuss my opioid usage with me, and have a talk with me encouraging me to lower the dosage. It’s always an awkward and unwelcome conversation, and just the possibility of it happening makes me dread going in there every month.

My pharmacist has also tried to tell me that I needed a Narcan prescription to get another refill. The problem is I would have to pay cash for it, because I don’t currently have insurance. Thankfully, I convinced him that I already had Narcan at home – which was true. But I could see other patients giving up and leaving without their refill.  

The thought process among pharmacists seems to be that if they give pain patients enough hurdles to jump before they can get their opioid prescriptions, that some will just give up. That keeps more opioids out of patients’ hands.

I think pharmacists underestimate how much harm they cause when they straight up lie to patients. They see what they’re doing as protecting people from the supposed harms of opioids. But what they’re actually doing is eroding patient trust in them and medical professionals in general.

When pharmacists lie about being unable to fill prescriptions, it makes me wonder what else they are lying about. And it’s not a far leap to start questioning other medical information they provide.

I’m not sure what the solution is to all of this, other than to call out the behavior and to make more patients aware that it could be happening to them. People should know that they aren’t crazy, and that it’s okay to push back if you think the pharmacy is lying.

Maybe one day there will be more regulations in place to protect patients from being lied to by pharmacists. Or maybe pharmacists will be replaced by artificial intelligence programs – which may come with brand new problems that we haven’t even considered yet. 

Until then, my hope for you is that the next time you need to get a controlled substance prescription filled, the whole process goes so smoothly that it’s ready for pick up before you even get to the pharmacy.

Clinical Trials Were Used as Marketing Ploys for Gabapentin and Other Drugs

By Sukhun Kang

Some clinical trials aren’t designed to answer scientific questions. They’re designed to market drugs. 

In our recently published research, my team and I analyzed over 34,000 industry-funded trials and found that hundreds of studies across seven medical fields were likely designed to promote a drug to physicians rather than to generate scientific data. For some fields, nearly 1% of clinical trials were for marketing purposes.

Known as seeding trials, these studies prioritize marketing over science while disguising their commercial purpose as legitimate research. Pharmaceutical companies use them to familiarize physicians with new products under the guise of data collection. Participants sign consent forms, believing they are contributing to medical knowledge.

In reality, patients are absorbing risks that serve corporate interests rather than resolving genuine uncertainty about the therapeutic potential of a drug.

The term seeding trial first entered the medical literature in 1994, when then-commissioner of the Food and Drug Administration David Kessler and his colleagues described such studies as attempts to entice doctors to prescribe new drugs through trials that appear to serve little scientific purpose.

Three decades later, the problem of seeding trials persists.

How Seeding Trials Work

While the structure of a seeding trial looks similar to legitimate clinical trials on the surface, the objectives are different.

In a typical clinical trial, researchers recruit patients across clinics and hospitals to test whether a treatment is safe and effective.

In contrast, the pharmaceutical company behind a seeding trial enrolls large numbers of physicians at many sites, each seeing only a few patients. The goal is exposure: getting doctors to prescribe the drug, not generating robust data. Doctors may be selected based on their prescribing volume rather than their research credentials.

In a legitimate trial, the number of study sites reflects the number of patients needed to answer a scientific question. In a seeding trial, the number of sites reflects the number of doctors the company wants to reach.

Seeding trials often target drugs already on the market and operate as Phase 4, or postmarketing, studies. These types of studies are typically conducted after a drug has been approved to monitor its long-term safety or effectiveness. This trial stage receives less regulatory scrutiny than trials for initial drug approval, and the aims of the study may have limited relevance to actual patient care. 

For example, a seeding trial might measure whether patients prefer the taste of a new formulation or how quickly a drug dissolves in the stomach, rather than whether it actually improves health outcomes.

Legitimate trials also have independent oversight, with committees of scientists and ethicists who monitor the study’s progress and can halt it if patients are being harmed.

In a seeding trial, this oversight is often minimal. The sponsor of the study – typically the pharmaceutical company funding the research – maintains heavy control over the trial’s design and conduct.

Vioxx and Gabapentin Seeding Trials

Seeding trials had attracted little public attention until litigation in the 1990s forced open the internal files of two major pharmaceutical companies, revealing that studies presented as science had been designed as marketing campaigns.

The most notorious example is Merck’s ADVANTAGE trial for the painkiller Vioxx (rofecoxib), which was first approved in 1999. The company presented the study, which ran from 1999 to 2001, as scientific research, but internal documents revealed that its primary purpose was to encourage physicians to prescribe Vioxx to their patients.

Meanwhile, Merck was accused of downplaying the significant cardiovascular risks associated with the drug. The consequences were severe: Approximately 30,000 lawsuits and nearly $5 billion in compensation followed Vioxx’s withdrawal from the market.

Parke-Davis’ STEPS trial for the painkiller Neurontin (gabapentin) – first approved in 1993 for epilepsy – followed a similar pattern of disguising marketing as research. Internal documents showed that the trial, which ran from 1996 to 1998, aimed to disseminate marketing messages through the medical literature and encourage clinicians to prescribe the drug off-label for conditions it was not approved for, such as neuropathic pain and bipolar disorder.

Unlike Vioxx, gabapentin was never withdrawn. The trial’s commercial legacy outlasted its scientific one.

These cases came to light only because litigation forced the release of internal company documents. Without that exposure, they would have remained indistinguishable from ordinary research.

How Common Are Seeding Trials?

My team and I study how pharmaceutical firms innovate and respond to regulations. To estimate the prevalence of seeding trials, we analyzed nearly 34,400 industry-funded Phase 3 and Phase 4 studies that posted results on ClinicalTrials.gov between 1998 and 2024. 

The trials covered seven therapeutic areas where researchers had previously documented seeding trials, including major depressive disorder, epilepsy, Type 2 diabetes and rheumatoid arthritis.

We screened these trials for criteria that prior research has identified as hallmarks of a seeded trial, such as low patient-to-site ratios and limited independent oversight.

Ultimately, we identified 204 trials – 0.59% – that had characteristics consistent with marketing-driven study design. The prevalence of these probable seeding trials in different disciplines ranged from 0.15% in osteoarthritis to 0.98% in rheumatoid arthritis.

These figures might understate the true scope of marketing-driven research. The criteria we used capture only the most identifiable cases of studies driven by marketing purposes. Definitively identifying seeding trials requires access to internal sponsor documents revealing the intent of the study, and those documents surface only through litigation or whistleblowers.

Many trials occupy an ambiguous middle ground, generating useful data while simultaneously serving promotional objectives. Without systematic surveillance, the full extent of marketing-driven studies remains unknown.

The criteria to identify seeding trials also require careful interpretation. A low patient-to-site ratio, for instance, can reflect the practical difficulties of enrolling patients in studies of drugs already on the market, such as trials testing new drug combinations or new uses for an existing treatment. These markers are best understood as signals of possible marketing intent warranting closer scrutiny, not proof of marketing intent.

Whether the prevalence of seeding trials has shifted with the expansion of transparency requirements over the past decade cannot be determined from existing registry data.

What Can Be Done

Seeding trials may be uncommon, but they are not accidental. They reflect structural incentives in a system where the companies that fund research also stand to gain from its results. Strengthening transparency in clinical trial registration, funding disclosure and oversight would help ensure that clinical research serves patients first.

Along with other researchers, we’ve proposed reforms that cluster around two areas. The first is standardized reporting that discloses trial funding, investigator payments, enrollment criteria and the rationale for site selection. 

The second is independent oversight, such as committees funded through pooled industry levies, which are fees collected from pharmaceutical companies to finance independent monitoring. Random audits with publicly available results are one form of such oversight.

Some infrastructure for tracking financial relationships between industry and physicians is already in place. In the U.S., the Open Payments database allows public tracking of industry payments to physicians. But regulatory variability across countries creates openings for companies to conduct marketing-driven trials in jurisdictions with weaker oversight, particularly in low- and middle-income countries.

Clinicians can protect themselves and their patients by screening for a set of red flags before agreeing to participate in or cite a trial in their research. These include unusually low patient-to-site ratios, selecting investigators based on prescribing volume, sponsor-dominated oversight and study endpoints of limited clinical relevance. Consent forms are among the few documents patients see before enrolling, and clearer disclosure of the commercial and scientific purpose of a study is among the reforms we have called for.

For patients, clinicians and regulators alike, the question to ask of any trial is the same: Whom does it really serve?

Sukhun Kang, PhD, is an Assistant Professor of Technology Management at University of California, Santa Barbara.

This article originally appeared in The Conversation and is republished with permission. 

Combining Opioids With a Cannabis-Based Medicine Doesn’t Add to Pain Relief

By Pat Anson

Combining a low dose of opioids with a cannabis-based medicine did not improve acute pain for people with arthritis, according to results of a small clinical study published in the journal Anesthesiology.

Animal studies have suggested that the two drugs might have a synergistic effect and provide better pain relief, but the study of 21 people with knee osteoarthritis found no added benefit. 

“Some patients believe combining cannabis with opioids can help with pain, and clinicians may recommend or prescribe it in states where cannabis is legal,” said lead author Katrina Hamilton, PhD, a Psychiatry Professor at Johns Hopkins School of Medicine. “Our study suggests that isn’t the case and patients may experience more side effects when the drugs are combined.”

There are some important caveats to the study that diminish its findings.

One is the design of the study and its small size – just 21 patients – who received placebo pills, hydromorphone alone, dronabinol alone, and a combination of hydromorphone and dronabinol. 

Participants received all four combinations prior to having pain induced by sticking their hands in cold water or having their skin rubbed with a “hot” capsaicin cream. That means the researchers were evaluating acute pain induced in a laboratory, not the chronic pain caused by arthritis.

Second, dronabinol (Marinol) is not cannabis. Dronabinol is a synthetic version of THC, the active ingredient in cannabis. It is FDA-approved to treat nausea and vomiting in chemotherapy patients, and to improve appetite in AIDS patients. Dronabinol was never intended to provide pain relief and has little in common with the various forms of cannabis (edibles, smoking, vaping) used in the real world. 

Third, while hydromorphone is a potent opioid, the oral dose (2 mg) that was used is relatively low – about 10 morphine milligram equivalents (MME). The research team had previously conducted a similar study using 4mg of hydromorphone. That also produced little pain relief for participants, so it’s not surprising that 2mg didn’t help either, although researchers say the lower dose has a “better safety profile.” 

The researchers found that taking hydromorphone and dronabinol, either alone or in combination, did not provide significant relief from acute pain. The opioid alone reduced pain sensitivity, while dronabinol did not, but neither meaningfully reduced participants’ self-reported pain.

When the two drugs were combined, side effects such as drowsiness, dizziness and impaired thinking were stronger and more noticeable, but without added pain relief.

“Opioid and cannabinoid medications failed to produce robust analgesia in experimentally induced pain among patients with knee osteoarthritis. In contrast to preclinical studies, there was no evidence of synergistic analgesic effects by combining hydromorphone and dronabinol,” researchers concluded.

While the dose of hydromorphone was low, the 10mg dose of dronabinol that was used in the study is a hefty amount. Interestingly, participants reported more of a “high” sensation from the dronabinol than from hydromorphone. But again, dronabinol is a synthetic version of cannabis and has little in common with what most cannabis consumers use.    

“In the real world, people often use cannabis differently, including lower starting doses, using gradually stronger doses, which may affect both benefits and side effects,” said Hamilton, acknowledging the limits of her study. “More research is needed to better understand how cannabis affects pain when used in real-world settings.”

Researchers Say Opioid Risk Tool Has ‘Too Many False Alarms’

By Pat Anson

The use of artificial intelligence (AI) continues to grow in healthcare, with patient health data and behavior increasingly being used to assess whether a patient is at risk of an illness or chronic health condition.

NarxCare and Epic, for example, scan electronic health records and prescription drug databases to create Opioid Risk Scores (ORS) for patients, which are then shared with healthcare providers to flag patients at risk of opioid misuse or an overdose. Patients deemed to be at high risk may not be able to get a prescription for opioids or they may be abandoned as “too risky.”

But a new study – the first of its kind – suggests that using opioid risk scores to predict patient outcomes is flawed, with unacceptably high rates of false positives.   

The study, recently published in the Journal of General Internal Medicine, looked at Epic’s opioid risk scores for over 700,000 U.S. patients being treated by primary care providers. The vast majority of patients (99.6%) were classified as low risk, with only 0.4% considered at high risk of an overdose or OUD.

It’s reassuring to see so many patients deemed low risk. But how accurate is the risk score in predicting patient outcomes? 

Of the 702,099 patients deemed low risk, only 2,177 went on to have an overdose or OUD diagnosis within the next 12 months. That means the system correctly predicted outcomes 99.7% of the time.

Conversely, of the 2,665 patients deemed high risk, only 185 later had an overdose or OUD diagnosis. That means Epic’s scoring system correctly predicted outcomes only about 7% of the time. 

Researchers say the false positive rate of 92.2% in the high risk category means that Epic’s ORS “produces too many false alarms” and is of little value to providers.  

“In this study, most high-risk patients were false positives, and most who developed OUD or overdosed were false negatives. Because these outcomes are rare, achieving adequate PPV (the proportion of cases that are accurate) is challenging. The ORS’s misclassification could undermine its external validity, leading to misallocated resources and missed interventions,” wrote lead author Stephanie Hooker, PhD, a Research Investigator at HealthPartners Institute.

“Missed interventions” in this case could mean a patient being denied opioid medication or being referred to addiction treatment, when neither move is justified.

On the flip side, Epic’s 99.7% success rate in identifying low risk patients also isn’t foolproof. 

Of the 2,362 patients who experienced an overdose or OUD diagnosis, Epic’s system flagged only 185 of them as high risk — which suggests that over two thousand were incorrectly labeled as “low risk.”

Maybe the lesson here is that “low risk” doesn’t mean no risk, and “high risk” doesn’t provide any certainty either.  

Pain management expert Dr. Lynn Webster says no opioid risk score — whether Epic’s or NarxCare’s – should be viewed as authoritative by doctors and pharmacists in making clinical decisions.     

“Both tools can be harmful if used punitively. The NarxCare scores have shown that overestimated risk may lead to forced tapering, abandonment, or other punitive responses, which could paradoxically increase overdose risk. With Epic, the harm is a bit different: the score can both stigmatize flagged patients and falsely reassure clinicians about the much larger group labeled low risk,” said Webster, a Senior Fellow at the Center for U.S. Policy (CUSP).

In 2023, CUSP petitioned the FDA to take Narxcare’s ORS software off the market as an unproven and misbranded medical device. The FDA rejected the petition on procedural grounds. 

In the case of Epic’s ORS, Webster says it is a mistake to count OUDs and overdoses in the same prediction model because they are distinct events. Someone can overdose without having OUD, while someone can have OUD without ever experiencing an overdose.   

“Opioid risk tools will always struggle to predict overdose death risk because overdoses can occur in patients who have no opioid use disorder and no aberrant drug-related behavior,” Webster told PNN. “Some patients overdose even when they take their medications exactly as prescribed. Overdose can also occur because of comorbid medical conditions or other factors unrelated to OUD.”

As flawed as they might be, Epic and NarxCare are already embedded in the U.S. healthcare system. Data on over 190 million patients has been collected by Epic’s MyChart software, while NarxCare is used by Walmart, Rite Aid, CVS and other major pharmacy chains to analyze patient risk.

“Whether the score comes from NarxCare or Epic, the core danger is the same: once a proprietary risk label is embedded in the chart, it can take on a false authority that changes how patients are treated,” says Webster.

Co-Prescribing of Opioids and Gabapentinoids Grows Despite Warnings

By Pat Anson

In 2019, the FDA warned that serious breathing problems can occur in patients who take gabapentinoids with opioids or other medications that suppress the central nervous system. The agency said elderly patients and those with pre-existing lung problems were at highest risk of respiratory depression, which can lead to a fatal overdose.

Those warnings went unheeded by many doctors, according to a new study that found the co-prescribing of gabapentinoids to patients on long-term opioid therapy increased over the past decade, rising from 47% in 2015 to 58.7% in 2023.

Gabapentinoids are a class of nerve medication originally developed to prevent seizures, but are widely prescribed off-label to treat pain. They include gabapentin (Neurontin) and pregabalin (Lyrica), as well as generic versions of the drugs.

Not only did co-prescribing with gabapentinoids increase, but the age of patients on long-term opioids also rose, from 52.5 years in 2015 to 60.5 in 2023. Nearly half of those patients (48.7%) are on Medicare. 

“Because older adults are at higher risk of adverse events from polypharmacy, the increased rates of coprescribing, particularly with gabapentinoids, raises additional safety concerns,”  said Thuy Nguyen, PhD, Assistant Professor of Health Management and Policy at the University of Michigan’s School of Public Health.

Nguyen and her colleagues' findings, published in a JAMA research letter, also document a steady decline in long-term opioid use, which coincides with federal and state guidelines that were imposed to limit opioid prescriptions.  

Between 2015 and 2023, the number of U.S. patients on long-term opioid therapy for at least 90 days fell from 5.6 million to about 4.2 million — a 24.3% decrease. 

At the same time, the average daily dose of opioids also declined, from 47.9 morphine milligram equivalents (MME) in 2015 to 38.6 MME in 2023 – which is in line with CDC guidelines that recommend caution when doses exceed 50 MME.

Researchers think more work is needed to reduce opioid use and to find alternative ways to relieve pain.

“With almost 5 million Americans on long-term prescription opioids for chronic pain, and likely millions more who are taking shorter courses of prescription opioids for acute pain, most clinicians are likely to care for someone using prescription opioids for pain, highlighting the pressing importance for investing in better treatment models for pain,” said senior author Pooja Lagisetty, MD, Associate Professor of Internal Medicine at the University of Michigan Medical School.

In addition to gabapentinoids, researchers tracked overlapping prescriptions for other controlled substances. They found that co-prescribing of long-term opioids with benzodiazepines declined from 43.8% in 2015 to 33.5% in 2023; while co-prescribing for stimulants rose from 5.9% to 6.7%.

In short, polypharmacy is relatively common with patients on long-term opioids, despite the known risks of combining certain drugs. 

Common side effects from gabapentin include brain fog, dizziness, weight gain, headache, fatigue, and anxiety. The drug has also been linked to a higher risk of dementia.

Those side effects may lead to a “prescribing cascade,” in which doctors mistakenly prescribe unnecessary medications to patients that cause even more side effects – never suspecting that gabapentin was the cause and they should consider discontinuing the drug.

In 2024, gabapentin was the fifth most prescribed drug in the U.S., with prescriptions nearly tripling since 2010. The number of patients prescribed gabapentin reached 15.5 million in 2024.

The off-label prescribing of gabapentin is legal and, in some cases, appropriate. But it has reached extreme levels, with studies estimating gabapentin is prescribed off-label up to 95% of the time. 

The Fear Mongering Over Tiger Woods’ Hydrocodone

By Crystal Lindell

Famed Golfer Tiger Woods was involved in a rollover car accident this week.

While the crash was likely caused because he was reportedly looking at his phone and changing the radio station when it happened, something else has taken up nearly all the coverage of the event: Two hydrocodone tablets.

Police said Woods failed a sobriety test at the scene and that they found two hydrocodone tablets on him at the time of the accident. The pills were marked “M367” which means they were likely 10mg hydrocodone and 325mg acetaminophen combination tablets, commonly known as a generic form of Norco or Vicodin.  

For context, hydrocodone is a Schedule Two controlled substance. A 10mg tablet is equal to 10 morphine milligram equivalents (MME). The CDC recommends caution when taking daily doses that exceed 50 MME. 

A hydrocodone tablet is routinely given out for post-operative pain or extensive dental work, such as wisdom tooth removal. I think anyone who’s ever had an out-patient surgery is probably familiar with the medication.

For chronic pain patients who already have a tolerance to opioids, hydrocodone is typically something that can be taken to reduce pain while also performing routine daily tasks, like cleaning the house and working. In fact, I took one right before writing this column.

It’s very likely that Tiger Woods takes them for chronic pain, seeing as how he has had multiple back surgeries. As such, he likely has a tolerance. 

That’s not to say that taking a couple hydrocodone couldn’t cause impaired driving and lead to a crash. It most definitely could. Especially if the reason Woods had two hydrocodone on him was because he had taken a bunch more.

It’s just that the way the media has covered the accident and the two pills would make you think he was basically found with two pounds of street fentanyl on him.

The Palm Beach Post ran a story headlined, "What is hydrocodone? Tiger Woods had the pills during DUI arrest.” In it, they write: 

“Hydrocodone is an opioid used to treat severe, chronic pain. The medication has a high risk of addiction and misuse with some of its most common side effects including dizziness, loss of consciousness and severe tiredness.”

I mean, yes, technically that’s true-ish. Hydrocodone is indeed used to treat severe chronic pain, but they left out “among other things.” Most people who take hydrocodone for chronic pain build up a tolerance and have no severe side effects, especially “loss of consciousness.”

Meanwhile, the New York Post ran a story headlined, "The dangerous risks of the pills found in Tiger Woods’ pocket in DUI arrest"

The article was especially egregious. In it, they write:

“While the drug is prescribed to treat chronic pain or manage pain after surgery or injury, using it is not without risks — and serious ones at that.

A highly addictive opioid, hydrocodone is in the same class as oxycodone, morphine and fentanyl — with a high enough risk of abuse that prescriptions have dropped by as much as a third since their peak in 2011.”

Trying to equate hydrocodone to fentanyl isn’t just disingenuous, it’s also potentially harmful to pain sufferers..

For those who don’t really know what hydrocodone is, that kind of messaging means a pain medication that will almost certainly be prescribed to them or a loved one at some point will become something to avoid. They may not take it when they need it. Or they may shame a loved one for taking it when they need it.

Not to mention how harmful coverage like this is to chronic pain patients in general, who have been trying to fight the stigma around opioid medications for years now.

There is legitimate concern that media stories like this will make already overly-cautious doctors even more hesitant to prescribe hydrocodone to patients who really need it.

On Reddit you can already find chronic pain patients worried about the ramifications of this type of coverage. One user referred to the New York Post article as, "Just another opportunity to demonize opioids and chronic pain patients."

Another poster lamented: "I see my PM (pain management) physician on Friday. I'm sure this will be a topic he'll bring up. Sigh..."

In another Reddit thread, a user writes:

“Everyone knows that people who take opioids long term get used to the effects of the opioids as their tolerance grows and you learn to have a pretty normal life and do things like work, go to school, and yes… drive. I mean, are we supposed to lock ourselves in our houses and never come out again and just wither away? No, we still have a life.”

It’s disappointing to see the news media jump on any chance to continue demonizing opioids. Reporters should know better by now. 

One day, they themselves will likely need Norco or Vicodin for some sort of pain. And because of their own work, they may have trouble getting it. 

Iran War Creates ‘Perfect Storm’ for Drug Shortages

By Pat Anson

The Iran war has disrupted the global supply chain so much that it could worsen shortages and raise prices of painkillers and other commonly used medications, according to experts. 

In addition to supplying much of the world with oil and natural gas, the Middle East serves as a crucial transportation hub for pharmaceutical companies. Ships and planes are being rerouted to avoid the region, which creates delays and higher shipping costs. 

“If the instability really persists, you’ll probably see lead times, transportation costs that can impact direct items that we need for our medicines, including the key starting materials into active pharmaceutical ingredients,” Gerren McHam, vice president of external affairs at the API Innovation Center, told The Hill.  

Even before the war, the UK was dealing with shortages of aspirin and co-codomal, a combination of paracetamol and codeine. Other drugs in short supply include those used to treat arthritis, diabetes, epilepsy and cancer.

The UK is reportedly “a few weeks away” from running out of some generic medicines. Like the United States, the UK relies heavily on generic pharmaceuticals produced in India.

“It’s the perfect storm. We have the conflict in the Gulf that caused the strait of Hormuz to shut down, and India is known as the pharmacy of the world. They produce a lot of the generic drugs and APIs (active pharmaceutical ingredients). With the geopolitical situation, it’s harder and harder to get those out,” said David Weeks, director of supply chain risk management at Moody’s. 

Before the war, Canada was also dealing with shortages of drugs used to treat pain and arthritis, according to a new report from the Canadian Arthritis Patient Alliance (CAPA). 

CAPA interviewed arthritis sufferers and their caregivers, who reported “profound disruptions to their physical and mental well-being” due to shortages of pain relievers such as Percocet, hydromorphone, Tylenol 3 and acetaminophen, as well as anti-inflammatory drugs and biologics used to treat arthritis. 

Patients and caregivers said they often had to make multiple trips to pharmacies before finding one that had their medications in stock.

“What happens to people who don’t have someone to support them through this? Would they just be waiting in the pharmacy while in immense pain - I would hate for my mom to be stuck in a situation like this on her own,” one caregiver told CAPA.

One bright spot is that shortages of oxycodone and acetaminophen with codeine that began last summer in Canada have largely ended. The drugs are now “generally available in pharmacies,” according to Health Canada.

The Iran war so far has had little immediate impact on pain patients in the U.S. – who have already been dealing with persistent shortages of opioid medication for several years. 

The American Society of Health-System Pharmacists (ASHP) continues to report shortages of oxycodone-acetaminophen tablets, oxycodone immediate release tablets, hydrocodone-acetaminophen tablets and morphine immediate release tablets; as well as injectable opioids used in surgery and emergency medicine. 

A new study published in JAMA Health Forum highlights how vulnerable the U.S. pharmaceutical industry is to global supply chain disruptions. 

Researchers at Yale University looked at stimulant shortages in 2022 and 2023, when many  patients with attention-deficit/hyperactivity disorder (ADHD) had difficulty filling their prescriptions. 

Although the limited supply was often blamed on increased demand and tight DEA production quotas, researchers say the more likely cause was a “historically unprecedented” decrease in US imports of amphetamine and other chemicals used to make stimulants. The shortfall in imports led to sudden production cutbacks by several stimulant manufacturers.

“Supply chain disruptions can occur in many places in the supply chain. However, descriptive evidence indicates that the most recent ADHD drug shortage may be associated with a disruption in the sourcing of raw ingredients from abroad,” researchers reported..

“More broadly, this economic evaluation reframes the discussion of ADHD medication shortages beyond DEA quotas, highlighting the vulnerability of US pharmaceutical manufacturing to international supply chain disruptions.” 

Pain Patients Ridicule FDA Plans for Opioid Disposal Systems

By Pat Anson

Should the FDA require pharmacies to provide in-home opioid disposal systems to patients, so they can safely dispose of their unused pain medication?

That’s the question being asked by the FDA in the Federal Register as it seeks public comment on the agency’s latest effort to combat opioid abuse. Although opioid prescriptions have already been reduced significantly – by 50% or more since 2011 – the FDA claims many pain patients still have excess opioids that can easily fall into the wrong hands.

“Having unused opioids laying around at home can be a significant risk to those struggling with opioids and can be a gateway for opioid-naïve family members,” said FDA Commissioner Marty Makary, MD. “We need to develop creative ways to address opioid misuse and abuse.”

Do patients really have opioids “laying around at home” that they don’t need? Given how far opioid prescriptions have fallen and how difficult they are to obtain, some find the idea laughable.

“Ridiculous, waste of money. I'm pretty sure there aren't any leftover pain medications that need disposal because they're not being prescribed to people who truly need them. This is like one of the most ridiculous wastes of money I have ever seen,” wrote April Stetka in her comment on the FDA proposal.

“I live with chronic pain. I am scrambling all the time to get enough medication to alleviate my pain,” said Isaac Arnett Jr. “The idea that people getting prescribed opioids for pain have extras sitting around is laughable.”

“This new proposed regulation is asinine, inhumane, morally corrupt, and continues to push a narrative full of xenophobia and stigma against people who require opioid analgesics. No one in their right mind would throw away life saving medications that are impossible to acquire in proper pain treating doses, if at all,” said Rodney Hipsher

“What are you going to do? Are you going to go into everyone’s house and go through their cabinets, looking for opioids?” asked Catherine Harris. “This is just one more step in treating surgical and chronic pain patients as toddlers, unable to monitor their own use and their own opioids. You have absolutely no right. This whole practice has been barbaric and the federal government and everybody involved should be ashamed at how far these policies have gone.” 

The FDA already requires pharmacies to provide prepaid envelopes to patients to mail back their unwanted opioids. Many pharmacies also have kiosks where unneeded medication can be dropped off, and the DEA regularly has drug “take back” days in local communities. As a last resort, the FDA even recommends flushing some excess opioids down the toilet.

Despite these efforts, the FDA claims that opioid analgesics remain the most common class of prescription drug that is misused, with about 8 million people reporting past-year misuse.

The term “misuse” is misleading, however, because it includes anyone not rigidly following their doctor’s orders. That can include someone taking less medication than what’s prescribed, or someone who stops taking a drug because it doesn’t work, has unwelcome side effects, or simply because they don’t need it anymore. 

Opioids are so difficult to obtain for some patients that they’ve resorted to hoarding excess pills because they’re uncertain if or when they’ll be able to get them in the future. In a PNN survey, nearly a third (32%) of pain patients admitted hoarding opioid medication — patients unlikely to need or want an in-home disposal system.

The odds of any excess opioids falling into the wrong hands are also low. According to the DEA, the estimated diversion rates for hydrocodone (0.53%) and oxycodone (0.69%) are both well under one percent.

Do Disposal Systems Work?

The FDA is vague about how opioid disposal systems should work, only that they be able to “inactivate, sequester, and/or absorb the opioid analgesic” so that it can be safely disposed in household trash.

At least nine commercial drug disposal systems already exist, but because the systems are not regulated and there are no industry standards to follow, there is limited information on their effectiveness or safety. The FDA says there have been reports to poison control centers of children accidentally being exposed to the disposal systems and of patients misunderstanding what the systems are for and ingesting their contents. 

The agency provides no estimate of a possible cost of in-home disposal systems or who should pay for it. But even if they were purchased by opioid manufacturers or pharmacies, you can bet those costs would eventually trickle down to insurers and/or patients. 

An in-home disposal system that is relatively inexpensive is DisposeRx. For $28.99, patients can get a lockable storage kit and packets containing a chemical powder that, when mixed with water, will bind to a medication and make it unusable.

A woman with two teenagers who cares for her elderly sick parents spoke highly of DisposeRx. She worries about her teens having access to her parents’ medications, and tries to get rid of them as soon as possible.

“I would save up my parents’ old meds on the counter until I had time to take them into a kiosk. There have been times where the kiosk is full or out of service and then I have to take everything back home where it goes on the counter again. This actually increases risk,” wrote Lara Popovich. “Now, as soon as I have an Rx my parents no longer need, I use DisposeRx powder and get rid of it immediately.”

People interested in leaving their own comments in the Federal Register have until April 6. You can learn more about the FDA proposal and submit a comment by clicking here.

U.S. Overdose Deaths Down Significantly

By Pat Anson

The number of fatal drug overdoses fell sharply in the U.S. in 2024, led by a significant decline in deaths involving illicit fentanyl, according to a new analysis.

Over 79,000 Americans lost their lives to a drug overdose in 2024, compared to 105,000 in 2023, a 24.5% decline in one year. Over 54,000 of the deaths in 2024 involved an opioid of some kind. 

The analysis by KFF further demonstrates the declining role of prescription opioids in the nation’s drug crisis. Prescribed opioids are now involved in about one in seven (13.6%) drug overdoses. 

In 2024, 10,851 Americans died from an overdose involving a natural or semi-synthethic prescription opioid, compared to 47,735 deaths involving synthetic opioids, mostly illicit fentanyl. 

Deaths from prescription opioids peaked at 17,029 in 2017 and have steadily declined.

U.S. Opioid Overdose Deaths 2004-2024

SOURCE: KFF

“Since the opioid epidemic was declared a public health emergency in 2017, it has claimed more than half a million lives. While the epidemic was initially driven by prescription opioids and heroin, it has evolved in recent years, to be dominated by illicit synthetic fentanyl — a substance significantly more potent than morphine,” KFF said. “Provisional CDC data suggest opioid deaths have continued to decline through 2025.”

The KFF analysis also looked at deaths involving alcohol, suicide and firearms.

In 2024, 48,824 American lives were lost to suicide, down slightly from the previous year. Firearms accounted for 57% of those deaths. There were 46,714 “alcohol-induced” deaths in 2024 caused by health conditions attributed to excessive alcohol use, about the same number of fentanyl overdoses.

Those deaths greatly outnumber fatal overdoses involving prescription opioids.

U.S. Deaths in 2024

Source: KFF

As PNN has reported, a recent study ranked alcohol as the 5th most harmful drug In the United States, behind illicit fentanyl, methamphetamine, crack and heroin. Prescription opioids ranked as the 7th most harmful drug in the U.S.

The analysis not only looked at the direct harm to drug users, but the indirect harm to families, communities and society at large caused by excessive drug use.

A panel of experts said the analysis shows how misdirected U.S. drug policy is, which is focused on crime and punitive measures to stop drug use, rather than public health measures to address substance use disorders. Criminalizing drug use may also be making the drug crisis worse, by taking legal drugs away from people who benefit from them.   

“All drugs have benefits to people who use them at least initially, and some may have ongoing benefits. For legal drugs, there may be social benefits like employment in related industries and taxation to fund public services,” wrote lead author Michael Broman, PhD, an Assistant Professor at The Ohio State University College of Social Work.

“Redirecting resources towards harm reduction may reduce social harms by reducing the economic cost of policing and surveilling people who use drugs. Concurrently, PWUD (people who use drugs) could remain contributing members of their families and communities.”