What You Should Know About Tylenol and Autism

By Mark Louie Ramos

Claims from the Trump White House about links between use of the painkiller acetaminophen – often sold under the brand name Tylenol in the U.S. – during pregnancy and development of autism have set off a deluge of responses across the medical, scientific and public health communities.

As a father of a child with level 2 autism – meaning autism that requires substantial support – and a statistician who works with such tools as those used in the association studies cited by the White House, I find it useful to think about the nuances of association versus causation in observational studies. I hope that this explanation is helpful to parents and expecting parents who, like me, are deeply invested in the well-being of their children.

Association Is Not Causation, But…

Most people have heard this before, but it bears repeating: Association does not imply causation.

An often-cited example is that there is a very strong association between ice cream sales and incidents of shark attacks. Of course, it goes without saying that shark attacks aren’t caused by ice cream sales. Rather, in the summertime, hot weather drives more appetite for ice cream and beach time. The increased number of people at the beach does, in turn, cause the likelihood of shark attacks to increase.

Yet pointing this out on its own is neither intellectually satisfying nor emotionally appeasing when it comes to real-life medical concerns, since an association does suggest potential for a causal relationship.

In other words, some associations do end up being convincingly causal. In fact, some of the most consequential discoveries of the past century in public health, like the links between smoking and lung cancer or the human papillomavirus (HPV) and cervical cancer, started out as findings of very strong association.

So when it comes to the issue of prenatal acetaminophen use and autism development, it is important to consider how strong the association found is, as well as the extent to which such an association could be considered causal.

Establishing Causal Association

So how do scientists determine if an observed association is actually causal?

The gold standard for doing so is conducting what are called randomized, controlled experiments. In these studies, participants are randomly assigned to receive treatment or not, and the environment where they are observed is controlled so that the only external element that differs among participants is whether they received treatment or not.

In doing this, researchers reasonably ensure that any difference in the outcomes of the participants can be directly attributed as being caused by whether they received the treatment. That is, any association between treatment and outcome can be considered causal.

Yet oftentimes, conducting such an experiment is impossible, unethical or both. For instance, it would be highly difficult to gather a cohort of pregnant women for an experiment and extremely unethical to randomly assign half of them to take acetaminophen, or any other medication for no particular reason, and the other half not to.

So when experiments are simply infeasible, an alternative is to make some reasonable assumptions on how observational data would behave if the association was causal and then see if the data aligns with these causal assumptions. This can very broadly be referred to as observational causal inference.

Parsing What the Studies Mean

So how does this apply to the current controversy over the potential for acetaminophen use during pregnancy to affect the fetus in a way that could result in a condition like autism?

Researchers who try to understand causal roles and links between one variable and potential health outcomes do so by considering: 1) the size and consistency of the association across multiple attempts to estimate it, and 2) the extent to which such association has been established under observational causal inference frameworks.

As early as 1987, researchers have been working to measure possible associations between acetaminophen use during pregnancy and autism. A number of these studies, including multiple large systematic reviews, have found evidence of such associations.

For instance, a 2025 review of 46 studies that examined association between acetaminophen use and an array of neurodevelopmental disorders, including autism, identified papers with five positive associations between acetaminophen and autism.

In one of those studies, which examined 73,881 births, the researchers found that children who were exposed to acetaminophen prenatally were 20% more likely to develop borderline or clinical autism spectrum conditions. Another examined 2.48 million births and reported an estimated association of only 5%.

Both of those are weak associations. For context, estimations of increased lung cancer risk from smoking in the 1950s were between 900% to 1,900%. That is, a smoker is 10 to 20 times more likely than a nonsmoker to develop lung cancer. By comparison, in the two autism studies above, a pregnant woman who takes acetaminophen is 1.05 to 1.20 times more likely than one who does not take the drug to have a child who would be later diagnosed with autism.

Not All Studies Are Created Equal

It’s also important to keep in mind that many factors can affect how well a study is able to estimate an association. In general, larger sample sizes provide both greater power to detect an association if one does exist, as well as improved precision over estimating the value of the association.

This does not mean that studies with smaller sample sizes are not valid, only that from a statistical perspective, researchers like me place greater confidence in an association drawn from a larger sample size.

Once an association – even a small one – is established, researchers then must consider the extent to which causation can be claimed. One way to do this is through what’s called dose-response. This means looking at whether the association is higher among women who took higher doses of acetaminophen during pregnancy.

The study mentioned above that looked at 2.48 million births shows an example of dose-response. It found that pregnant women who reported taking higher doses have higher autism risk.

Another way to examine possible causality in this context is to analyze sibling outcomes, which that same paper did. Researchers looked at whether associations between acetaminophen and autism persisted within families with more than one child.

For example, in a family with two children, if the mother used acetaminophen during one pregnancy and that child was later diagnosed with autism, but she did not use it during the other pregnancy and that child was not diagnosed, then this strengthens the causal claim.

Conversely, if acetaminophen was used during the pregnancy of the child who was not diagnosed with autism and not used during the pregnancy of the child who was, then that weakens the causal claim. When this was included in the analysis, the dose-response disappeared, and in fact the overall 5% increased risk mentioned before likewise disappeared. This weakens the claim of a causal relationship.

At present, there is clearly not enough evidence to establish a causal association between prenatal acetaminophen use and autism.

Yet as a parent who wonders if my daughter will ever be able to write her name, or hold a job or raise kids of her own, I understand that such explanations may not appease the fears or concerns of an expecting mother who is suffering from a fever.

Naturally, all of us want absolute certainty. But that’s not possible when it comes to acetaminophen use, at least not at this time.

Your doctor will be able to provide you with much sounder advice than any existing study on this topic. Your OB-GYNs are very likely aware of these studies and have much better judgment as to how these results should be considered in the context of your personal medical history and needs.

Researchers, meanwhile, will continue to dig deeper into the science of this critically important issue and, hopefully, provide greater clarity in the years to come.

Mark Louie Ramos, PhD, is an Assistant Research Professor of Health Policy and Administration at The Pennsylvania State University.

His research experience includes statistical development and multidisciplinary projects involving large datasets such as the United Kingdom Biobank, the National Health and Nutrition Examination Survey, and the United States Military Health System. He has taught mathematics and statistics subjects for over 20 years.

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

Over 15 Million Americans Prescribed Gabapentin Despite Warnings

By Pat Anson

The use of gabapentin (Neurontin) continues to soar in the United State, often for chronic pain and other health conditions the drug is not approved to treat, according to a new analysis by CDC researchers.

In 2024, gabapentin was the fifth most prescribed drug in the U.S., with prescriptions nearly tripling since 2010, according to findings published in the Annals of Internal Medicine. The number of patients prescribed gabapentin reached 15.5 million in 2024, up from 5.8 million in 2010.

Gabapentin was originally developed as an anti-convulsant. It was first approved by the FDA as a treatment for epilepsy and later for neuropathic pain caused by shingles. But it is also routinely prescribed off-label for depression, ADHD, migraine, fibromyalgia, bipolar disorder, cancer pain, postoperative pain, and many other conditions.

Off-label prescribing is legal and, in some cases, appropriate. But for gabapentin it has reached extreme levels, with studies estimating the drug is prescribed off-label up to 95% of the time. Gabapentin has been used to treat so many different health conditions that a drug company executive called it “snake oil.”

"This study highlights a slowed, but continued, increase in gabapentin dispensing from retail pharmacies in the United States," wrote lead author Gery Guy Jr., PhD, of the CDC National Center for Injury Prevention and Control. "As gabapentin dispensing continues to increase, particularly among older populations, prescribing physicians and advanced practitioners should be alert to the potential adverse effects of gabapentin."

Side effects from gabapentin include mood swings, depression, dizziness, fatigue and drowsiness.  A recent study found that gabapentin raises the risk of dementia.

Gabapentin has also become a street drug, after drug users found it can heighten the effects of heroin, cocaine and other illicit substances. Nearly 10% of overdose deaths in 2020 involved gabapentin, with most of those deaths also involving illicit opioids. A recent analysis of drug tests found gabapentin in over 13% of urine samples that tested positive for fentanyl.

“Although gabapentin alone is infrequently involved in fatal overdose, serious breathing difficulties may occur in patients with respiratory conditions or those using gabapentin in combination with opioids,” said Guy.

The CDC has a checkered history with gabapentin. The agency’s 2016 opioid prescribing guideline promoted gabapentin and its sister drug pregabalin as non-opioid alternatives for neuropathic pain, without any mention of their possible side effects.

The CDC’s revised 2022 opioid guideline is a bit more cautious. It says gabapentin can produce “small to moderate improvements in chronic pain and function,” but can also cause blurred vision, cognitive effects, sedation, and weight gain.

Medical experts say doctors need to do a better job warning patients about the side effects of gabapentin, and the medication should be stopped if a patient reports little or no benefit. They also think medical guidelines have exaggerated the effectiveness of gabapentin and should be revised.

How Opiophobia Paved the Way for Tylenol Hysteria

By Crystal Lindell

The dirty little secret about alternatives to opioids is that they are all mostly bullshit.

They’re expensive, sometimes outright dangerous, and perhaps worst of all, ineffective.

So when doctors are telling you that you don’t need opioids to treat your pain, what they are really saying is that you don’t need pain treatment at all.

And that’s exactly the message that people are getting from the Trump administration’s recent guidance to avoid taking Tylenol while pregnant.

Specifically, the administration is now advising women not to use acetaminophen — which goes by the brand name Tylenol — for pain and fever during pregnancy due to claims that it raises the risk of their babies developing autism. 

Aside from the fact that science behind this claim is not definitive, the other major problem is that there is no safe alternative to acetaminophen that a woman can take for pain and fever while pregnant. Over-the-counter pain relievers like aspirin and ibuprofen can damage the kidneys of unborn babies.

President Trump admitted as much during the press conference about the new guidance, putting the onus on pregnant women to “tough it out” by not taking Tylenol

“Sadly, first question, what can you take instead? It's actually, there's not an alternative to that,” Trump said. “And as you know, other medicines are absolutely proven bad. I mean, they've been proven bad, the aspirins and the Advils and others, right?

“But if you can't tough it out, if you can't do it, that's what you're going to have to do. You'll take a Tylenol, but it'll be very sparingly.”

That’s a genuinely inhumane response to the pain pregnant women often endure, because what he’s really saying is that you just should not treat pain while pregnant. It’s also on-brand messaging for an opiophobic country that’s been dismissing everyone’s pain for almost a decade now.

As it turns out, when you tell people that their pain doesn’t deserve to be treated by opioids, then it’s a quick path to the idea that pain shouldn’t be treated by other substances, be they cannabis or kratom or Tylenol. 

In the end, it all really comes down to a fundamental question of whether or not pain is worthy of treatment.

And unfortunately, for many healthcare professionals and government officials, the answer is a resounding “no.” They do not believe that pain is worthy of treatment – as long as it’s not their pain. Because, make no mistake, when these types of policies come out, that’s exactly who they apply to: other people.

They know that they themselves will get to use opioids if and when the time comes that they need them for their own pain. And they don’t expect to have a pregnancy themselves, so of course they don’t care if pregnant women can’t have their pain treated.

It's why Trump can so dismissively say "there's no downside in not taking it." He means there is no downside to him if you don’t take Tylenol.

But for pregnant women, there most certainly is a downside. Failing to treat fever and significant pain can pose serious risks to both the mother and baby, resulting in miscarriages, birth defects, depression, infections and high blood pressure.

Enduring untreated pain can wear you down in ways you can’t even predict. It will destroy your sleep, steal your hope, and even make you mean. When it’s your pain, you’ll do anything to make it stop.

Pain is a medical condition on its own, and “toughing it out” is not an effective treatment. Until we as patients and voters demand better, I fear both the government and our healthcare system will continue chipping away at the pain treatments we still have — until there is literally nothing left but silent prayers and fleeting wishes.

Trump: ‘Don’t Take Tylenol If You’re Pregnant’

By Pat Anson

The Trump administration is advising women not to use acetaminophen (Tylenol) for pain and fever during pregnancy due the risk of their babies developing autism. About two-thirds of expectant mothers in the United States use acetaminophen.

Speaking at the White House, President Trump and Health and Human Services Secretary Robert F. Kennedy also linked childhood immunization shots to rising rates of autism, which now affects about 1 in 31 American children.

“They pump so much stuff into those beautiful little babies, it's a disgrace. I don't see it. I think it's very bad. They're pumping -- it looks like they're pumping into a horse. You have a little child, a little fragile child and you get a vat of 80 different vaccines, I guess, 80 different blends and they pump it in,” Trump said in a rambling statement that veered from Tylenol to vaccines and back again.

“And I will say there are parts of the world that don’t take Tylenol. I mean, there’s a rumor. And I don’t know if it’s so or not, that Cuba, they don’t have Tylenol because they don’t have the money for Tylenol and they have virtually no autism.”

Cuba does in fact have autism, although at low rates. It also has limited supplies of acetaminophen, which is known as paracetamol outside the U.S.

Acetaminophen is one of the most widely used over-the-counter pain relievers in the world, and medical professionals generally consider it one of the safest ways to relieve pain and fever. High fevers during pregnancy have been associated with birth defects and miscarriages, while poorly treated pain can lead to depression, insomnia and other harms to pregnant women.

The FDA warns expectant mothers not to take other over-the-counter pain relievers, such as aspirin and ibuprofen, because they can damage the kidneys of unborn babies.

The UK’s National Health Service (NHS) maintains that it is safe for pregnant women to use paracetamol. “Paracetamol is the first choice of painkiller if you're pregnant or breastfeeding. It's been taken by many pregnant and breastfeeding women with no harmful effects in the mother or baby,” the NHS says on its website.

Kenvue, the maker of Tylenol, also disputes any link between acetaminophen and autism.

“We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with any suggestion otherwise and are deeply concerned with the health risk this poses for expecting mothers,” the company said in a statement.

In recent years, a handful of studies have linked the use of acetaminophen by pregnant women to autism, Attention-Deficit Hyperactivity Disorder (ADHD), and hyperactivity in children, although the evidence is not conclusive. A large 2021 study in Europe found that women who took acetaminophen while pregnant were 19% more likely to have children with autism.

“Today, the FDA will issue a physicians’ notice about the risk of acetaminophen during pregnancy and begin the process to initiate a (warning) label change. HHS will launch a nationwide public service campaign to inform families and protect public health,” Kennedy said.

“HHS wants to encourage physicians to exercise their best judgment and the use of acetaminophen for fevers and pain in pregnancy by prescribing the lowest effective dose for the shortest necessary duration and only when treatment is required.”    

‘Outright Lies and Dangerous Advice’ 

The FDA’s current warning label for acetaminophen cautions people about the risk of liver damage and other side effects, but does not specifically warn pregnant women about using the pain reliever. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

“The announcement on autism was the saddest display of a lack of evidence, rumors, recycling old myths, lousy advice, outright lies and dangerous advice I have ever witnessed by anyone in authority in the world claiming to know anything about science,” Arthur Caplan, PhD, founding head of the Division of Medical Ethics at NYU’s Grossman School of Medicine told The New York Times.

One of the reasons autism rates have risen in the U.S. is that its definition changed. Once considered extremely rare, a task force added Asperger’s syndrome to the list of autistic conditions, which resulted in a surge of new cases. Over the next decade, autism rates surged from 1 in 2,500 children to 1 in 31.

“The rapid rise in autism cases is not because of vaccines or environmental toxins, but rather is the result of changes in the way that autism is defined and assessed — changes that I helped put into place,” Dr. Allen Frances, a psychiatrist who led the task force, wrote in a recent op/ed in The New York Times.

“Our intentions were good, but we underestimated the enormous unintended consequences of adding the new diagnosis. The resulting explosion in cases included many instances of overdiagnosis — children were labeled with a serious condition for challenges that would better be viewed as a variation of normal. It also sowed the seeds of conspiracy theories and anti-vaccine beliefs as people wondered how to explain the rising cases.”

An FDA statement today also cautioned about drawing too many conclusions about links between autism and acetaminophen.

“It is important to note that while an association between acetaminophen and neurological conditions has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature,” the FDA said in a press release.

“It is also noted that acetaminophen is the only over-the-counter drug approved for use to treat fevers during pregnancy, and high fevers in pregnant women can pose a risk to their children. Additionally, aspirin and ibuprofen have well-documented adverse impacts on the fetus.”

Former Secretary of Veterans Affairs Calls for ‘Opioid-Free VA’

By Crystal Lindell

An alarming new column in The Hill is advocating for an opioid-free Veterans Affairs health system by 2030 – a move that would leave countless veterans and their families without effective pain relief.

Headlined “Whiskey, tobacco, and pain pills: The VA can be an opioid-free health system,” the op/ed was written by David Shulkin, MD, who was Secretary of Veterans Affairs in the first Trump administration, and the VA’s Under Secretary of Health in the Obama administration.

His opening line gets straight to the point he’s trying to make: “There is a time for everything. Now is the time for the Department of Veterans Affairs to go opioid-free.”

His column is promoting a dangerous message, and I fear that Shulkin’s credentials will lead people to take his stance seriously. It’s especially abhorrent because veterans are more likely to have chronic pain and have suicide rates twice as high as civilians, often due to poorly treated pain.

The VA and Department of Defense medical guidelines already discourage opioids from being prescribed for chronic pain, especially for younger patients of military age. The guidelines only allow for short-acting opioids to be prescribed for short-term acute pain.  

Shulkin frames opioids as a sort of magic-spell curse that can ruin lives after just one dose:

“The real opportunity lies in preventing opioid initiation,” Shulkin wrote. “The VA’s comprehensive, integrated system makes it uniquely positioned to lead the nation in eliminating opioid use and become the first opioid-free health system in the country. While it would be inappropriate to abruptly discontinue opioids for current chronic users, the VA could immediately begin limiting opioids for acute pain and adopt new alternatives. 

Shulkin claims that over half of veterans receive opioids for post-operative acute pain, as though that number is too high. But having opioid medication after surgery isn't just common practice, it's the most humane response. And there’s little evidence it leads to opioid addiction.

In fact, I’d go so far as to say that the fact that only half of veterans get opioids post-op is probably too low. Of course, I couldn’t fact check Shulkin’s numbers because the link he uses to validate his claim about how many veterans receive opioids post-op doesn’t even work. It just goes to a “404 error” page not found.  

Shulkin also claims that “roughly 10 percent” of veterans develop opioid addiction after surgery. But the link provided for that misleading claim takes you to a large meta-analysis study of over 4 million chronic pain patients around the world (mostly civilians), which has no relevance to how many U.S. veterans become addicted after surgery.

As noted in the headline to his column, Shulkin also compares opioids to alcohol and tobacco, citing the fact that VA doctors used to recommend both to patients to help make them “more comfortable.”  

“Just as we no longer prescribe alcohol or allow tobacco on VA campuses, the day will come when we look back and wonder why opioids were ever part of routine care,” he writes. 

Of course, there are glaring differences between opioids and those two substances: Opioids require a prescription, while alcohol and tobacco can be bought over the counter. They’re also involved in many more deaths than prescription opioids. 

To be frank, if patients could go out and purchase hydrocodone as easily as they can buy whiskey or a pack of cigarettes, I wouldn’t have a problem with what Shulkin is saying. Patients lacking a prescription from the VA would still have the option to treat their pain how they saw fit — whether or not a doctor approved of the methods would be irrelevant. 

Unfortunately, that’s not the case. And as such, trying to make the VA opioid-free within five years is inhumane. 

‘Additional Advances Are Emerging’

Of course, since Shulkin is advocating for zero opioid prescriptions, one might assume that he would at least offer a list of reasonable non-opioid pain relieving alternatives. But here too, his evidence is lacking. 

His first suggestion is a selective sodium channel blocker called Journavx (suzetrigine), which was recently approved by the FDA, even though it’s no more effective than a low dose of Vicodin. 

According to Yale Medicine, Journavx has very specific limitations. It’s "not a cure-all" and is only meant for moderate-to-severe acute pain, which is short-term pain after trauma or surgery. 

"This means, based on the current evidence, that it would likely be used primarily in the hospital setting and only for a few days," says Robert Chow, MD, a Yale Medicine anesthesiologist and pain management specialist.

Shulkin says "additional advances are emerging” for other non-opioid alternatives, including drugs targeting peptide-receptors that “appear to provide effective pain relief.”

So to recap, Shulkin wants the entire VA system – which provides healthcare to over 8 million military service members, veterans and their families – should go opioid free because we now have one sodium channel blocker and "additional advances are emerging."

Shulkin admits "it would be inappropriate to abruptly discontinue opioids” for long-term patients on opioids. But something tells me that such a warning would be ignored if the VA ever actually did go "opioid free," given the fact that many veterans have already been abruptly tapered off opioids.

I suspect that if Shulkin ever needed opioids for his own pain, he would not hesitate to take them. His is the type of column that is only written about other people’s pain – and other people’s pain is always easy to endure. 

I hope that his proposal is ignored and ridiculed as the nonsense it is. But after witnessing opiophobia for the last decade, I worry that the opposite will happen, and that policymakers will take Shulkin’s ideas seriously. 

Opioids aren’t just helpful – for many veterans they are necessary. And any medical professional advocating for their elimination should not be working in medicine at all. 

If we want to make the world a better place, we need to take pain seriously and treat it as the grave condition it often is. That means giving patients access to opioids when they need them. 

Early Receipt of Opioids Reduces Hospitalization of Children with Sickle Cell Disease

By Pat Anson

Early administration of opioids for pain relief in emergency departments significantly reduces the chances of a child with sickle cell disease being hospitalized, according to a large new study published in JAMA Pediatrics. 

Sickle cell disease (SCD) is a genetic disorder that causes red blood cells to form in a crescent or sickle shape, which creates painful blockages in blood vessels. About 100,000 Americans live with sickle cell disease, primarily people of African or Hispanic descent.

It’s not uncommon for someone with SCD to visit an ER a few times each year due to pain or complications such as anemia, stroke, infection and organ failure. Many patients with SCD feel stigmatized when they visit an ER, where their pain is not taken seriously and they are seen as drug seekers. That delays their treatment, even though medical guidelines recommend early treatment with opioids and other pain relievers.    

“If we can stabilize and treat patients’ pain, they won’t need to be admitted to the hospital, where they would miss school, their families would miss work, and it’s disruptive to their lives,” said co-author Elizabeth Alpern, MD, Professor and Vice Chair in the Department of Pediatrics at Northwestern University Feinberg School of Medicine.

Alpern and her colleagues reviewed over 9,000 ER visits by 2,538 children with an uncomplicated SCD pain flare between 2019 and 2021. Their findings offer some of the first evidence that faster pain management with opioids can lead to better outcomes for pediatric SCD patients.

Children who received their first opioid dose within 60 minutes of arrival in the ER were 15% less likely to be hospitalized. The odds of hospitalization dropped even further when a second dose was administered within 30 minutes of the first. 

“We were able to statistically show that if patients receive a timely first dose of opioid medications and a timely second dose of opioid medications, we could drastically reduce the number of hospital admissions within this population,” said co-author Jacqueline Corboy, MD, Assistant Professor of Pediatrics in the Division of Emergency Medicine at the Feinberg School of Medicine. “This is the first study that shows concrete evidence, so this is really important.” 

The study was a collaborative effort among 12 pediatric hospitals. Two smaller, single-site studies showed no association between early receipt of opioids and lower odds of hospitalization.

SCD patients have few alternatives to opioids for pain relief. Last year Pfizer took the sickle cell medication Oxbryta off the market over concerns that it could be causing deaths and other complications. A 2022 study also found that SCD patients given corticosteroids are more likely to be hospitalized with severe pain.

Compared to other chronic illnesses, SCD has received little attention from researchers and pharmaceutical companies, resulting in a lag in the development of new treatments. Until 2018, only one drug was approved by the FDA to treat sickle cell patients. Bone marrow and stem cell transplants are currently the only curative therapies for SCD.

It’s Rare for Chronic Pain Patients to Overdose on Opioids

By Neen Monty

The Penington Institute is an Australian non-profit public health and drug policy research organization. Its core mission is to study drug use “in a safe, considerate and practical way. We seek solutions, not scapegoats. We strive for positive outcomes, not negative stereotypes.”

A most worthy cause.

Each year, Penington releases Australia’s Annual Overdose Report, the country’s most comprehensive study of overdose trends and impacts. I am not against the work of the Penington Institute. On the contrary, they serve a very necessary purpose and have a noble goal.

However, for several years running, they have demonized chronic pain patients and twisted the statistics to inflate the harms of prescription opioids. And this is generally what I write about. To correct the record.

Here’s the download page to Penington’s 2025 report. It documents how many overdoses and what substances were involved. The report relates to data from the 2023 calendar year. Paging through it, something jumped out at me immediately.

Naturally, I jumped straight to the ‘Opioids’ section. There is a table, with key facts. One of these key facts is:

“From 2019-2023, there were 163 unintentional drug-induced deaths involving pharmaceutical opioids as the sole drug type.”

That’s an average of nearly 33 people who died accidentally every year when pharmaceutical opioids were the sole drug type. 33 people. In a country with 27.4 million people.

Does that sound like an opioid crisis to you? Does that sound like a reason to deny tens of thousands of patients access to safe and effective pain relief?

Do you know what immediately occurred to me when I realised that less than 50 people per year die from prescription opioid overdose?

I remembered this 2023 report from the Therapeutic Goods Administration (Australia’s version of the U.S. Food and Drug Administration), justifying their changes to paracetamol scheduling. That’s acetaminophen for those of you in the U.S.

Paracetamol pack sizes were reduced to 16 tablets per packet and supermarkets could only sell two packs per person. Larger packs were only available at pharmacies, and some required a pharmacist’s approval.

Do you know why they made paracetamol harder to get?

Because 50 Australians were dying every year from paracetamol overdoses, with rates of intentional overdose highest among adolescents and young adults.

There was an outcry when the changes came into effect. Chronic pain patients were again being harmed by policy because a different patient group was overdosing.

Because 50 people die of paracetamol overdoses per year in Australia.

Do you get what I am saying?

Paracetamol is still available over-the-counter in Australia, albeit in smaller pack sizes. And yet opioids are almost impossible to access.

Fewer Australians die from prescription opioid overdoses than from paracetamol overdoses. This was true long before any changes were made in opioid scheduling in 2020, making opioids much harder to get.

Opioid prescribing was already declining in 2020, so there was no need to change opioid prescribing practices. Certainly no medical need. In fact, this policy change caused a great deal of harm to those who live with constant, severe pain, and has had no benefits. For anyone.

Please think about it. Reflect upon it. Make it make sense. How is this anything other than a witch hunt?

Paracetamol kills more people than prescription opioids, yet it’s still available over the counter. And doctors are torturing people who live with painful, progressive and incurable diseases, by denying us access to safe and effective pain relief.

Because 33 people die of prescription opioid overdoses every year. While 50 people die of paracetamol overdoses.

Does Australia have an opioid crisis? No.

Does Australia have a prescription opioid crisis? Also no!

We never had a prescription opioid crisis. And we were never heading for one. Prescription opioid overdoes have been falling in Australia since 2018. Check the statistics.

Unlearn what you have been told and learn the true statistics.

There was no need to make changes in 2020. Yet those changes caused interminable suffering to people who live with constant, severe pain from illness or injury.

Most chronic pain patients are still suffering. Many have died.

Does this seem fair to you? Does this seem right? Does it seem reasonable?

Does any of this seem like good policy?

To be clear, I am not saying that opioids should be available over-the-counter. Please do not twist my words to imply that.

Opioids for severe, daily pain should be managed as they were before 2020. By general practitioners who know their patients well.

There should be no dose ceilings because there is no evidence that dose ceilings reduce overdoses and death. GPs are more than capable of prescribing an appropriate dose and duration to manage severe chronic pain.

Instead, chronic pain patients in Australia are forced to go to a pain management specialist, who barely knows them and rarely understands their pain.

People who live with severe, daily pain from disease and injury have a right to pain relief. We need help.

And this year’s Penington report shows that we are not the ones who are overdosing.

It is time to restore access to safe and effective pain relief for those who desperately need it. Chronic pain kills far more often than the opioids prescribed for chronic pain do. Patients die from heart attacks, strokes, hypertension, and other stress-induced conditions when their pain is not treated.  

The true cause of most overdose deaths is polypharmacy: multiple drugs, both legal and illegal, that are often mixed with alcohol.

Targeting people who live with painful, progressive and incurable diseases and injuries, denying us access to pain medication, is never going to reduce overdoses by illicit drug users. They are two different patient populations.

It is not chronic pain patients who are overdosing.

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. She has created a website for Pain Patient Advocacy Australia to show that prescription opioids can be safe and effective, even when taken long term. You can subscribe to Neen’s newsletter on Substack, “Arthritic Chick on Chronic Pain.”

5 Myths About Opioids That I Believed, Until I Needed Them

By Crystal Lindell

I had been enduring debilitating pain for months by the time I was given my first hydrocodone prescription for chronic pain in 2013.

At the time, I didn’t even know that hydrocodone was an opioid.

I had only heard of Vicodin being an opioid, and that was only because I lived near the Wisconsin border, where there are lots of Packer fans. The news that former Green Bay quarterback Brett Favre had to go to rehab for his Vicodin use was part of the local conversation.

But I had no idea that hydrocodone was the active ingredient in Vicodin.

It’s been over a decade now, and I have come to rely on opioids to manage the chronic pain I have in my right ribs, which is technically called “intercostal neuralgia.”

Before I needed opioids for pain relief, I used to buy into a lot of common cultural myths about them. Below is a look at what I used to believe, and how my views eventually shifted.

Myth #1: Only People Who ‘Misuse’ Opioids Have Physical Withdrawal

When I got my first hydrocodone prescription, I didn’t know it was a controlled substance with strict limits on how often you can get refills. And I definitely didn’t know that I would go through withdrawal if I stopped taking them abruptly.

My doctor prescribed 10mg pills and the label said: “Take 1-2 every 4-6 hours.”

So, that’s exactly what I did: Two pills every four to six hours.

My pain was (and still is) intense, but at the time I was still trying to keep pace with my pre-chronic pain lifestyle, which meant doing everything possible to push the pain away so that I could work and have a somewhat normal life.

But that meant that I ran out of my prescription early – something I was not aware was even a problem. When the doctor’s office said I would need to wait a couple days for a refill, I didn’t think it would be a big deal. Surely, I could easily ride out a couple of days without hydrocodone, no problem. After all, I had been taking them as prescribed.

Yeah. That’s not what happened. Turns out you actually cannot go from 40 to 80 mg of hydrocodone a day to zero.

I naively went to work that day, and still remember the trauma of spending the entire shift in the bathroom with diarrhea, nausea, horrible flu-like aches, and an odd feeling of anxiety.

Turns out, anyone can go through withdrawal from opioids. There is no magic spell that doctors can cast to give you immunity from it, just because you’re taking opioids exactly as prescribed. Your body doesn’t know the difference.

And that physical withdrawal is also not indicative that you have “a problem.”

In fact, it’s one of the reasons I think the entire conversation around addiction is often more nuanced than people want to admit. Taking a dose to combat withdrawal is often labeled as “misuse” – even though anyone can have withdrawal. 

And anyone who’s been through it knows that you’ll do almost anything to make it stop.

Myth #2: The Best Way to Stop Using Opioids Is Quitting Cold Turkey

There’s a common myth that the best way to stop using an addictive substance is to go cold turkey. That’s usually not true for things like nicotine and alcohol, and it’s also not true for opioids.

I used to believe in the common framing for this. That if you stopped using opioids cold turkey, made it through 72 hours of withdrawal, and then took just one dose, it would reset the whole process. You’d have to go through withdrawal all over again.

That’s not true. In fact, taking a dose after going longer than usual without one is often part of the tapering process that works best for getting off opioids. 

Ideally, you taper off slowly by lowering the amount you’re taking each day. So, if you’re on 40mg of hydrocodone a day, the best way to stop using it is to take 35mg daily for a week or so, then 30 mg, and so on until you get down to zero.

That’s the best way to reach success long-term and actually get off the medication, if that is your goal.

If you’re looking for more realistic tips on how to stop taking opioids, see “A Survival Guide for Opioid Withdrawal” that I wrote for PNN with my partner a few years ago. You can trust the advice because we learned it ourselves the hard way.

Myth #3: Opioid Doses Last as Long as Manufacturers Claim

I was eventually prescribed extended-release morphine pills for my chronic pain, and was told that each one should last a full eight hours. I was also told that hydrocodone should last four to six hours.

Unfortunately, neither of those things are true. So-called “extended release” morphine lasts about four hours, while the short-acting hydrocodone can stop working in just two or three hours.

So, it’s not wise to take another dose whenever your pain comes back. If you do that, you’ll end up running out of your prescription early every month.

Instead, you should expect to go through periods throughout the day when your pain starts to come back – and then you have to count down until your next dose.

Myth #4: Even One Dose of an Opioid Creates a High Risk of Addiction

Before I started taking opioids, I honestly believed the myth that just one 10mg dose of Vicodin could result in life-long addiction.

In reality, that’s nearly impossible. In fact, even among patients who take opioids long-term, the rate of addiction is still incredibly low. Estimates vary widely, but according to experts who have studied it, people who take opioids over long periods have addiction rates of 1 to 3 percent.   

Opioids are often framed as being so addictive that anyone can get hooked, so any exposure to them is dangerous and risky. In reality, low-dose opioids are incredibly safe, and most patients taking prescription opioids never develop an addiction to them

Myth #5: If Someone Is ‘Really’ in Pain, Doctors Will Prescribe Opioids

I am a little ashamed to admit this, but I used to think of a Vicodin prescription as an indicator of whether or not someone’s pain was actually severe.

If a doctor prescribed Vicodin to someone, that meant they were in “real” pain.

Boy, was I wrong.

While dealing with pain myself, I quickly learned that doctors will often ignore severe pain in patients because they don’t want to deal with the hassle of prescribing a controlled substance. That reluctance has only gotten worse since 2013. Much worse.

These days, doctors withhold opioid medication from post-op patients, cancer patients, palliative care patients, and even hospice patients. All of them are still in very real pain though.

Whether or not a doctor validates your pain with an opioid prescription has no bearing on how severe your pain actually is.

There’s a lot of misinformation about opioids and these are just some of the common myths perpetuated about them. While it’s understandable to believe them if you’ve actually never needed opioids, I encourage everyone to keep an open mind. After all, if you wait until you or a loved one needs opioids to see the truth, it may be too late.

VA Researchers Say Opioid Guidelines Should Include Cancer Patients

By Pat Anson

Most medical guidelines that limit the use of opioid pain medication are intended only for patients suffering from “non-cancer” pain. The CDC, for example, says that its guideline “does not apply to patients undergoing cancer-related pain treatment,” because the potential for addiction and overdose “might not be relevant” to patients at risk of dying.

That long-held policy is now being questioned. In a study published in CANCER, the medical journal of the American Cancer Society, VA researchers say cancer patients are living longer and may be at risk of “persistent opioid use.”

The study, led by researchers at the VA Medical Center in Philadelphia and the Perelman School of Medicine at the University of Pennsylvania, followed over 9,000 veterans who had surgery for early-stage cancer, mostly prostate, colon, bladder or lung cancers. About a third of those patients also needed chemotherapy, immunotherapy or radiation therapy.  

Thirteen months after surgery, about one in ten patients (10.6%) were still prescribed opioids for pain relief. And about 4% of them were co-prescribed benzodiazepines for anxiety, a combination of medications that some consider risky.

Although none of the veterans overdosed from taking opioids, and less than one percent (0.78%) were diagnosed with opioid use disorder, researchers say stronger measures are needed to limit the use of opioids by cancer patients.

“Minimizing opioid exposure associated with cancer treatment while providing effective pain control will decrease long-term health risks among cancer survivors,” said lead author Marilyn Schapira, MD, Professor of Medicine at the University of Pennsylvania and Co-Director at the Center for Health Equity Research at the VA Medical Center.

“Prescription opioid practices associated with cancer treatment may lead to unsafe and long-term opioid treatment (LTOT) and the related adverse outcomes of opioid use disorder, opioid overdose, and nonoverdose adverse events, including suicide.”

Schapira and her colleagues say medical guidelines that exclude cancer patients from opioid prescribing limits, such as the CDC guideline and the Department of Defense/Veterans Affairs guideline, should be rewritten.

“There may be benefits to extending general guidelines regarding prescription opioids to those facing cancer treatment in consideration of health and well-being during the years of survivorship," researchers concluded. “Efforts should be taken to mitigate long-term opioid use and its potential adverse effects in this population. This is especially true because cancer is increasingly recognized as a chronic condition, and survivors of cancer are living longer.”

Cancer patients with a history of chronic pain, greater comorbidities, lower socioeconomic status, and those who received chemotherapy were said to be at “especially high risk of opioid use in the year after surgery.”

Regardless of what the guidelines say, many U.S. patients being treated for cancer already have trouble getting opioids for pain control. A recent study found a 24% decline in opioid prescribing to cancer patients on Medicare after the CDC’s 2016 guideline. Another study found the number of cancer patients seeking treatment for pain in hospital emergency rooms doubled. About a quarter of the patients had cancer pain so severe they were admitted.  

Other studies have found that cancer patients are getting smaller and fewer doses of opioids, while some can’t get them at all. A recent survey of palliative care doctors in New York City found that nine out of ten (88%) reported frequent obstacles in getting opioids for their patients due to tight supplies at pharmacies. Nearly a third said the shortages resulted in sub-optimal care for their patients.

One of the more egregious examples of a cancer patient being unable to get opioids was the case of April Doyle, a California woman with metastatic breast cancer who couldn’t get her Norco prescription filled at a Rite Aid pharmacy. April recorded a tearful video in the pharmacy parking lot and shared it online, where it went viral. Outrage over the incident led to an apology from Rite Aid and her prescription being filled. April died a year later at the age of 42, leaving behind a 9-year-old son.

How To Get More Pain Relief From Rx Opioids

By Drs. Forest Tennant, Martin Porcelli and Scott Guess

Due to a multitude of legal restrictions and biases, many persons living with pain who take opioid medication can’t get enough relief to function, be comfortable, and have quality of life.

Summarized below are some of the ways we have found to boost or enhance the pain-relieving effect of prescription opioids.

Take a Booster (Potentiator)

Opioids trigger the endorphin receptor to relieve pain. If you simultaneously take a medicine or supplement that triggers a different receptor or suppresses inflammation, pain relief is enhanced. This boosting effect is the reason opioids are combined with acetaminophen or aspirin in pain medications such as Vicodin or Percocet.

Here is a list of potential non-prescription boosters. You may have to experiment to find one or two that boost the potency of your opioid. You can swallow the booster with your oral opioid or take the booster within 15 minutes after taking the opioid.

• Taurine 1000 mg

• Glutamine 1000 mg

• Lion’s Mane mushrooms

• Quercetin

• Benadryl

• St. John’s wort

• White willow bark

• Cannabidiol (CBD)

• Kava

• Palmitoylethanolamide (PEA) 300 to 600 mg

Under the Tongue vs Swallowing

A medication dissolved under the tongue (sublingually) is always more potent than if you swallow it whole. That’s because digestion in the stomach and intestines may wipe out as much as 50% of an oral opioid’s pain relief capability.

Try dissolving an opioid tablet under your tongue. You may find it much more effective, as it will enter the bloodstream faster. We recommend starting with half your usual dose and increase it as needed, being careful not to exceed your usual dose. Discuss this practice with your medical practitioner.

Don’t Forget Aspirin

Aspirin has been disparaged to the point that people are afraid to take it. It is still one of the very best opioid boosters. Dissolve it under your tongue to avoid stomach upset or bleeding.

Receptor Health

The central nervous system has many receptors (“action points”) that relieve pain. They need to stay healthy and active to provide maximal pain relief. A good nutrition program that consists of daily protein, vitamin D, and magnesium helps keep nerve receptors healthy and maximizes opioid pain relief.

Bedtime Preparation

Some medicinals taken at bedtime have the effect of making the next day’s opioids more effective. Here are some suggestions:

• Metformin 500 mg + L-Theanine 200 mg

• Tryptophan 500 to 1000 mg

• Amitriptyline

• Pentoxifylline

Cannabis

Some persons find that cannabis provides significant pain relief, while others experience little or no relief.

Do not take cannabis products within four hours before or after an opioid dosage to avoid over-sedation, loss of coordination, and mental deficiency.

Kratom

Kratom is the only non-prescription herbal supplement that has opioid-like effects. It comes in a variety of forms, usually natural leaf powder that is sold in capsules, edibles or drinks.

Kratom can be simultaneously taken with opioids, but be wary of synthetic or concentrated kratom as its potency may be unknown or too high.

All persons who take opioids for pain relief should find a kratom form and dosage that relieves pain. Given today’s adverse attitudes and restrictions on opioids, a person relying on prescription opioids alone must face the fact that their medical practitioners may end or reduce their opioid therapy at any time. When this happens, you may have to rely on kratom.

Prescription Boosters

Many physicians prescribe non-opioid medications for pain relief, such as gabapentin (Neurontin), clonidine, tizanidine, baclofen, and pregabalin (Lyrica). These can also be used to boost the potency of opioids. Take these medications within four hours before or after your opioid dose.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. Readers interested in learning more about his research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can subscribe to its research bulletins here.

Martin J. Porcelli, DO, is a family medicine doctor in Pomona, CA and is affiliated with Casa Colina Hospital.

Scott Guess, PharmD, operates an independent pharmacy and clinic in Atascadero, CA that specializes in pain management and arachnoiditis.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section. 

Top Officials at CDC Resign After Director Fired in Dispute Over Vaccines

By Pat Anson

CDC Director Susan Monarez has been fired by President Trump, capping a week-long drama that began with Monarez refusing to make changes in vaccine policy ordered by Health and Human Services Secretary Robert F. Kennedy Jr.  At least four top CDC officials resigned in protest after Monarez was ousted, creating further chaos at the country’s top public health agency.   

“The agency is in trouble, and we need to fix it, and we are fixing it, and it may be that some people should not be working there anymore,” Kennedy told Fox News.

Kennedy, a longtime critic of vaccines, demanded that Monarez resign or be fired, and she refused. Monarez had been acting CDC director since President Trump took office and was confirmed by the US Senate only a month ago.

Attorneys for Monarez say she could only be fired by the president and accused Kennedy of “weaponizing public health for political gain” by dismissing CDC scientists and appointing vaccine skeptics to CDC advisory committees.

“When CDC Director Susan Monarez refused to rubber-stamp unscientific, reckless directives and fire dedicated health experts, she chose protecting the public over serving a political agenda. For that, she has been targeted,” attorneys Mark Zaid and Abbe Lowell said in a statement. “The attack on Dr. Monarez is a warning to every American: Our evidence-based systems are being undermined from within.”

Tensions have been rising at the CDC for months after steep cuts in its staff and budget, followed by the overhaul of advisory panels ordered by Kennedy.

Recently, a gunman angry about Covid vaccines fire hundreds of shots at CDC headquarters in Atlanta, killing a policeman and traumatizing employees. Both President Trump and Kennedy were notably silent after the attack, which only made morale worse.  

More than 750 HHS staffers signed a letter saying the Trump administration “failed to adequately respond” to the attack and that Kennedy was “endangering the nation’s health by repeatedly spreading inaccurate health information.”

‘This Is a Heartbreaking Decision’

The four high-ranking CDC officials who resigned are Dr. Debra Houry, the CDC’s deputy director and chief medical officer; Dr. Demetre Daskalakis, who headed the center that makes vaccine recommendations; Dr. Daniel Jernigan, who oversaw vaccine safety; and Dr. Jennifer Layden, who was in charge of the CDC’s public health data. Kennedy recently pressured the agency to share health data for a study to confirm his beliefs that vaccines cause autism.

“This is a heartbreaking decision that I make with a heavy heart,” Houry said in an email to colleagues.

When she started at CDC over a decade ago, Houry was director of the CDC’s National Center for Injury Prevention and Control, which oversaw the secretive drafting of the agency’s controversial 2016 opioid guideline. Critics say anti-opioid activists had too much influence on the guideline and accused then-CDC Director Thomas Frieden of “blatant violations” of federal advisory committee laws.

Although the guideline was voluntary, it was so widely implemented by doctors that it caused “serious harm” to pain patients who were tapered to lower doses or no longer able to get opioid medication. Many suffered through withdrawal, uncontrolled pain, psychological distress and, in some cases, suicide.

Things got so bad, the CDC revised its guideline in 2022 to give doctors more flexibility in prescribing opioids. By then, Houry had left the Injury Center and been promoted to chief medical officer.

“From a very narrow viewpoint, some might take comfort in the resignation of Debra Houry as chief medical officer of CDC. Prior to holding that position, she had been Tom Frieden's action arm for implementing the original opioid guidelines. However, like Frieden, she also had a history of positive accomplishments and her current resignation appears to be a laudable matter of principle,” said Dr. Charles LeBaron, a retired CDC epidemiologist.

LeBaron wrote a book critical of the agency’s guideline and its leadership: “Greed to Do Good: The Untold Story of CDC’s Disastrous War on Opioids.” He says the current turmoil at CDC and HHS is likely to disrupt other public health efforts besides vaccines.  

“This is a developing situation in which efforts to address both pain and addiction treatment matters are really suffering collateral damage in a war over vaccines and related matters of public health,“ LeBaron told PNN in an email. “Whatever happens, it's hard to imagine that RFK Jr, with his ‘healing farms’ approach to eliminating opioid use, is ever going to make matters better in this area. 

“Until we get a sane person in charge of HHS, it's hard to see how anything useful in any area, including pain treatment, is going to happen. If you want my opinion, the more that the pain treatment community (along with everybody else) can successfully urge for RFK Jr's replacement, the more likely we are to see some progress at some point, rather than the current headline-de-jour chaos.”

The most immediate impact of the turmoil at CDC is uncertainty and delay in the release of the updated 2025-2026 Covid vaccines. Earlier this week, the FDA approved the use of new vaccines made by Pfizer, Moderna and Novavax, but limited who can get them to older Americans or those with a high-risk health condition. Several states are reporting a surge in Covid infections caused by a new Omicron variant.

FDA approval will be enough for some states to begin offering the new Covid vaccines, but other states will wait for a recommendation from the CDC’s new advisory panel, which now includes doctors and researchers who have publicly questioned the safety of vaccines.

The Advisory Committee on Immunization Practices is scheduled to meet September 18-19. According to the agenda, the panel will discuss many common vaccines, including those for COVID-19, hepatitis, measles, mumps, and rubella. The panel will consider whether to “revise the list of vaccines for administration to vaccine-eligible children.”

Back Pain Will Cost Australia Billions, but Rx Opioids Dismissed as a Remedy

By Crystal Lindell

A new study is sounding the alarm about lost worker productivity in Australia caused by chronic back pain, but an inexpensive remedy is being dismissed as “low-value or harmful.” 

Published in JAMA and led by researchers at Monash University, the study projects massive losses in productivity in Australia caused by long-term back pain. In 2024, nearly 3 million Australians had chronic back problems. That’s projected to grow to nearly 3.3 million by 2033.

The researchers estimate that back problems will result in an estimated loss of 3.4 million productivity-adjusted life-years over a 10-year period. That equates to a loss of more than $638 billion in Australian dollars in the country’s gross domestic product. That’s about $414 billion in US dollars.

That’s a lot of lost productivity and money. Just a 10% reduction in the number of workers with long-term back problems would save over $41 billion Australian dollars 

“Substantial economic gains could be achieved from reducing the prevalence and impact of the condition,” wrote lead author Sean Docking, PhD, a health economist at Monash University. “Action is needed to reduce the prevalence and burden of long-term back problems, with a focus on better-quality care and supporting people of working age to remain in the workforce and working productively.”

Indeed, there is a need to reduce the “impact of the condition.” I completely agree. However, while the authors call for interventions, they ignore an obvious tool that used to be widely available in Australia until 2018: codeine. 

That’s when Australia made codeine available by prescription only. Until then, the opioid was sold over-the-counter, and no doubt was often used to help people with back pain get out of bed, go to work, and be more productive.

While pop culture has often crafted a view that opioid medications are sleep inducing and that people who take them are lazy, the reality is that millions of people take them so that they can work and be productive. That’s especially true for mild, low-risk opioids like codeine.

The Monash researchers also point out that calling in sick and working less creates “considerable financial stress and may disproportionally impact already disadvantaged communities.”

Again, I agree. Not being able to work because of chronic pain can definitely result in a huge financial burden. And effectively treating that pain can literally make it possible for people to continue working and not rely on public assistance programs.

Unfortunately, rather than addressing this or offering practical solutions, the researchers dismiss all opioids as a “low-value” care option. Instead, they recommend “high-value” care, which basically consists of vague advice to “stay active” and get back to work as soon as possible. 

“A major way of addressing the burden of long-term back problems is to reduce the proportion of individuals who receive low-value or harmful care,” researchers said. “However, contrary to evidence-based guidelines, low-value care is prevalent. Examples of low-value care have been associated with longer absences from work. By contrast, high-value care could prevent chronicity, improve patient health outcomes, and result in productivity gains that benefit society.”

Perhaps the use of opioids is associated with “longer absences” because the pain medications are only given out when patients have severe back pain and really should stay at home.

It’s frustrating that, like many pain studies these days, the Monash researchers found a way to work in a negative view of opioids and suggest that they don’t “benefit society” or improve patient health.  

The fact that they left out how the crackdown on opioid prescribing contributes to lost productivity is also disheartening, especially when opioids are an inexpensive remedy.

When people have adequate pain relief, they can be productive. When they don’t, they can’t. Chronic pain patients understand this. Now we just need medical professionals to understand it too.

The Strange Denial of Complications Caused by Poorly Treated Pain

By Drs. Forest Tennant and Scott Guess

There has been no shortage of controversy, scandal and fraud regarding the opioid and pain crises of the past decade. One standout in the debate over opioids and pain treatment has been a lack of an honest, objective discussion of the benefits of pain care.

A basic tenet in medical practice and therapeutics is what is called the “risk-benefit” ratio. This is a simple analysis of whether a specific drug or therapeutic measure has more benefit than risk.

For example, the risk-benefit of drugs taken during pregnancy is well-known and established. But strangely, the debate over whether opioids have more benefit than risk in the treatment of pain has never been broached.

None of the parties involved, especially the anti-opioid zealots, will discuss any benefit that opioids may bring. In fact, essentially their only discussion is that opioids are a risk for overdose and addiction, so they have no benefit and shouldn’t be used.  

This risk is overrated and overstated in relation to opioids prescribed and monitored by a physician. According to the CDC, total opioid overdose deaths in the US (including deaths from illicit opioids) were 24 deaths per 100,000 population in 2023.

That compares to the overdose death rate for prescribed opioids, which was 4 per 100,000 population. That is a raw number for prescribed opioids.  Some data reports opioid deaths among physician monitored chronic pain patients to be as low at 0.1 per 100,000 population. 

In other words, the overdose risk of evidence with prescription opioid is minuscule.

Pain has a number of pathological complications that benefit from opioid therapy. In addition to physical relief, there are humanitarian benefits, such as a reduction in suffering, and the ability to mentally and physically function as a productive person.

When poorly treated or left untreated, chronic pain has profound negative and deleterious effects on the cardiovascular and endocrine (hormonal) systems. Pain puts the cardiovascular system into overdrive, which raises blood pressure and pulse rates. Coronary artery spasm may also result from severe chronic pain.

We can personally attest to prescribing blood pressure medication and nitroglycerin to many pain patients at risk of cardiac arrest or heart failure.

Hormonal suppression and deficiency of cortisol, testosterone, estradiol and other hormones are also common in undertreated chronic pain patients. Cortisol levels can drop below levels that sustain life. We have administered emergency cortisone to pain patients who were severely ill, debilitated, and near collapse because they had inadequate cortisol levels.

Among Dr. Thomas Addison’s eleven reported original cases of Addison’s Disease in 1855, about half had serious intractable pain conditions such as adhesive arachnoiditis.

Chronic pain has also been found to alter blood glucose and lipids (cholesterol). Sleep deprivation is another major problem in pain patients.  And anorexia with malnutrition is common.

Given the medical complications induced by pain, one would logically think that there would always be a discussion of risk-benefit when discussing opioid therapy. But we’ve never heard or seen such a discussion in medical literature or in political circles.

As if denial of benefits over risks weren’t bad enough, an even stranger denial has occurred. We have searched the major medical textbooks used in medical schools today, and couldn’t find a single word that chronic pain is a risk for hypertension and cardiac disease, much less hormonal deficiencies.

Isn’t it time we quit denying that chronic pain has medical complications that can be easily treated with opioids and other medicinals? The risks of opioid therapy simply don’t outweigh the benefits. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. Readers interested in learning more about his research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can subscribe to its research bulletins here.   

Scott Guess, PharmD, operates an independent pharmacy and clinic in Atascadero, CA that specializes in pain management and arachnoiditis.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Hydromorphone Injections Can Quickly Relieve Intractable Pain

By Dr. Forest Tennant

I recall the time over a decade ago when Anazao Laboratory in Tampa, Florida informed me they had developed ultra-high potency (50 mg/ml) hydromorphone for palliative pain care. Anazao Labs was well aware of my patients’ needs, since they formulated my endocrine medicinals. 

In contrast to the other injectable opioids, Anazao’s hydromorphone formulation could be injected subcutaneously under the skin rather than intramuscularly.  The injection required a very small amount of fluid (.1 to .2 ml) that was administered with an allergy or insulin syringe.

My patients’ pain was called “intractable” to meet California’s Medical Board guideline and legal definitions.  The criteria for patients to enter my clinic was a determination that there was a high risk of death within one year unless opioid treatment could be administered. The top causes of intractable pain were adhesive arachnoiditis, traumatic brain injury, severe neuropathies (CRPS), autoimmune disease, and post-cancer care.

I recall the first patient to whom I prescribed ultra-high potency hydromorphone.  She was not receiving adequate pain relief with long-acting and breakthrough opioids, so she was referred for an intrathecal implanted device (pain pump) for opioid administration.  Due primarily to its cost and insurance reasons, she could not obtain this expensive treatment, so I chose to experiment with the new ultra-high potency hydromorphone. 

It worked remarkably well.  In fact, she soon found she didn’t require a long-acting or breakthrough opioid. Using the new hydromorphone formulation, she dropped her daily morphine milligram equivalent (MME) dosage from over 500 to less than 100 MME per day.

After success with this patient, I prescribed the hydromorphone formulation to other patients on high dose oral opioids, who could not obtain intrathecal opioids or an implanted electrical stimulator.  All the patients tolerated and adjusted well to it.  Ultra-high dose hydromorphone became an alternative to intrathecal opioids at my pain clinic.

When I later prescribed the hydromorphone formulation to other patients with intractable pain, I found that I could eliminate or reduce their use of high dose opioids through oral, patch or sublingual administration, and obtain equal or superior pain relief.

I have since retired from clinical practice, but still believe this is a major reason for using ultra-high potency hydromorphone for patients in severe pain.  My initial experience told me that the hydromorphone formulation could be an alternative to standard intractable pain care, which is the combined use of a long-acting opioid with a short-acting opioid for breakthrough pain. That therapy has shortcomings, because long-acting opioids suppress endocrine levels, which can lead to a wide range of health problems.

My procedure in prescribing hydromorphone was to instruct both the patient and a live-in family member on proper injection technique, secure storage, and maintaining sterility.  At the time I closed my clinic, I probably had about 2 dozen patients who successfully used this innovative formulation.

I have come to some conclusions that go against common beliefs about opioid therapy.  First and foremost, high potency hydromorphone can usually substitute in most cases for long-acting opioids such as OxyContin, transdermal fentanyl, and methadone.  Effective pain relief occurs within minutes after the injection, so the patient doesn’t have a proclivity to follow the opioid dose with a sedative or neuropathic drug such as a benzodiazepine. 

Seldom did my patients use over 3 to 4 injections a day.  To date, I know of no overdoses occurring.  I attribute this to hydromorphone’s rapid, potent, short-acting activity, which doesn’t invite the use of other drugs (including alcohol), to help the patient achieve pain relief.  Blood levels of the hydromorphone don’t stay elevated longer than about two hours, which protects against overdose. Pain relief remains much longer, however, likely because it is hydrophilic in neurologic tissues.

In summary, I have found ultra-high potency hydromorphone to be a significant advance in palliative pain care for intractable pain patients.  It has proven to be a bonafide alternative to intrathecal opioid delivery and to high opioid dosages necessary when combining the use of long and short acting opioids.  Its unique properties seem to reduce the risk of overdose. 

Families and patients can be trained to safely and effectively use this medicinal to relieve suffering from the most severe forms of intractable pain.  Unfortunately, it is an under-recognized and underused treatment for the palliative care of intractable pain patients.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. Readers interested in learning more about his research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can subscribe to its research bulletins here.   

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section. 

Limits on Rx Opioids Led to Unintended Consequences in Australia

By Pat Anson

An Australian study highlights some of the benefits and unintended consequences of efforts to limit the prescribing of opioid pain medication.

Like the United States, there’s been a fair amount of controversy in Australia about opioid medication and the role it played in the so-called opioid crisis. In response, Australian regulator took two steps in 2020 to limit prescribing: creating prescription drug monitoring programs (PDMPs), and limiting the amount of opioids and repeat prescriptions subsidized by the government.

To see how well the changes worked, researchers analyzed emergency department (ED) visits by patients prescribed opioids by primary care doctors in Victoria, the second most-populated state in Australia with over seven million people. Victoria was the first state to adopt a mandatory PDMP, which doesn’t stop a doctor from prescribing opioids but alerts them to possible misuse by a patient.

The research findings, published in the Medical Journal of Australia, show that ED visits by patients on prescription opioids fell by 11.8 visits per 100,000 people after opioids restrictions were implemented. At the same time, however, researchers identified a short-term but statistically significant increase of 7.3 ED visits per 100,000 people that were linked to non‐opioid substances.

The study didn’t identify what those non-opioid substances were, but researchers suspect that some were uncontrolled medications, such as pregabalin and antidepressants, which are often prescribed as alternatives to opioids for pain relief.

“As we expected, the new policies were associated with reduced opioid‐related harm; the reduced availability of prescription opioids presumably explains this change. We also expected that the changes would have unintended effects, and found an immediate increase in the non‐opioid substance‐related ED presentation rate that was greater among people prescribed opioids than in the control group,” researchers reported.

“One possible mechanism underlying the increase in non‐opioid substance‐related harms could be related to increased prescribing of unmonitored pain medicines, such as pregabalin and tricyclic antidepressants, following the introduction of the prescription drug monitoring program.”

PDMPs have also had unintended consequences in the United States. In a 2021 study, the Reason Foundation found that opioid prescribing declined in states that adopted PDMPs, but that overdoses involving heroin, illicit fentanyl and cocaine significantly increased – suggesting that some patients were substituting illicit drugs for prescription opioids.

The focus on prescription opioids may have been misplaced in Victoria. According to a 2023 report by the state’s coroner, the anti-anxiety medication diazepam was the lead drug involved in fatal overdoses (213 deaths) in Victoria, followed by heroin (204 deaths), methamphetamine (164 deaths), alcohol (153 deaths) and pregabalin (78 deaths). In contrast, oxycodone was involved in 41 deaths and codeine in 24 deaths.