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

By Crystal Lindell

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

What Rescheduling Will Mean for Marijuana

By Dr. Chris Meyers

The Drug Enforcement Administration announced in early 2024 that it would act on President Joe Biden’s call to reclassify marijuana, moving it from the tightly controlled Schedule I category that it has been in since 1970 to the less restrictive Schedule III status of the Controlled Substances Act. That triggered a long process of hearings and reviews that will not be completed until after the presidential election in November.

The news drew strong reactions from critics: 25 Republican lawmakers sent a letter to Attorney General Merrick Garland protesting any changes to federal marijuana laws. They argued that the decision “was not properly researched … and is merely responding to the popularity of marijuana and not the actual science.”

As a philosopher and drug policy expert, I focus on assessing arguments and evidence rather than politics or rhetoric. So, what are the arguments for and against rescheduling cannabis?

Scheduling Under Controlled Substances Act

The Controlled Substances Act places each prohibited drug into one of five schedules based on known medical use, addictive potential and safety. Schedule I drugs – which, along with marijuana, also includes heroin, LSD, psilocybin, ecstasy (MDMA) and quaaludes – is the most restrictive category.

Schedule I substances cannot be legally used for any purpose, including medical use or research, though an exception for research can be made with special permission from the DEA. The criteria for inclusion in the Schedule I category is that the substance has a high potential for abuse, is extremely addictive and has “no currently accepted medical use.”

Schedule II, which is slightly less restrictive than Schedule I, includes drugs that are addictive and potentially unsafe but also have some accepted medical use. These include strong opioids such as fentanyl, as well as cocaine, PCP and methamphetamine. Though they are still tightly regulated, Schedule II drugs can be used medically with a prescription or administered by a licensed physician.

Schedule III is much less restrictive and is intended for substances with legitimate medical use and only moderate risk of abuse or dependency. This category includes low-dose morphine, anabolic steroids and ketamine.

Schedule IV – which includes the sedative Valium, the weak opioid tramadol and sleep medicines such as Ambien – is even less restrictive.

The least restrictive category is Schedule V, which includes cough syrups with codeine and calcium channel blockers such as gabapentin and pregabalin. All scheduled drugs require a doctor’s prescription and can be distributed only by licensed pharmacies.

Schedule III Would Only Legalize Some Medical Use

The push to reschedule is largely to make federal laws consistent with state medical marijuana programs that – as of October 2024 – are legal in 38 states plus the District of Columbia.

Moving marijuana to Schedule III would not change its legal status in states where it is banned. It would make marijuana legal at the federal level but only for medical use. Recreational use would still be federally prohibited, even though it is currently legal in 24 states plus Washington.

Rescheduling, however, might not make medical marijuana any easier for patients to access and could even make it much harder for some. Currently, getting a medical marijuana card is quite easy in most states. In Washington D.C., where I live, patients can self-certify.

If marijuana is reclassified as Schedule III, medical marijuana programs will have to start requiring a doctor’s prescription, just like with all other scheduled substances. And it could be distributed only by licensed pharmacies, which would put medical dispensaries that are now selling it without a license from the Food and Drug Administration out of business.

Rescheduling, however, would give medical marijuana legitimacy as a bona fide medicine. And the intent of the move is to increase access, even if it is unclear how rescheduling would achieve that.

So, assuming that rescheduling would have the intended effect of expanding access to medical marijuana, should it be rescheduled?

Medical Uses of Marijuana

Though there are three criteria for Schedule I in the Controlled Substances Act, the DEA in fact relies on only the medical use criterion. This was the basis of the DEA’s proposal to reschedule marijuana. The fact that almost 75% of Americans live in a state with a medical marijuana program suggests that marijuana has an accepted medical use.

More importantly, Schedule III of the Controlled Substances Act already includes dronabinol, which is delta-9 THC, the active ingredient in marijuana. Although dronabinol is synthesized in the lab rather than extracted from the cannabis plant, it is the exact same molecule. The FDA approved THC in the form of dronabinol in 1985 for treating anorexia caused by HIV/AIDS as well as nausea and vomiting due to chemotherapy. Placing marijuana in the same schedule as its primary active ingredient makes a lot of sense.

Another argument in favor of rescheduling is that it would open up new opportunities for medical research into marijuana’s effects, research that is currently hampered by its Schedule I status. This work is critical because the system of cannabinoid receptors through which marijuana causes its therapeutic and psychoactive effects is crucial for almost every aspect of human functioning.

Research has shown that cannabis is effective not only in treating nausea and AIDS but also chronic pain and some symptoms of multiple sclerosis.

There is also good evidence that marijuana can help treat other conditions, including Lou Gehrig’s disease (amyotrophic lateral sclerosis, or ALS), glaucoma, irritable bowel syndrome, insomnia, migraine, post-traumatic stress disorder and Tourette syndrome. Keeping marijuana in the Schedule I category severely hampers research that might establish more effective treatments for these conditions.

Balancing Risks and Benefits

Those opposed to rescheduling cite possible health risks associated with marijuana consumption. Heavy use is linked to an increased risk of developing schizophrenia. However, the increased risk of schizophrenia from cannabis use is comparable to that caused by watching excessive television, eating junk food or smoking cigarettes.

Long-term marijuana use can also lead to sleep problems and diminished visuospatial memory. It can also cause gastrointestinal trouble, such as cannabis hyperemesis syndrome, which is characterized by nausea, vomiting and abdominal pain. The symptoms, while extremely unpleasant, are temporary and occur only after consuming marijuana. The condition disappears in people who stop using.

Marijuana use can also be addictive. According to the Centers for Disease Control and Prevention, about three out of every 10 regular marijuana users meet the diagnostic criteria for cannabis use disorder.

All of the concerns above are legitimate, though it is worth noting that virtually no effective medicine is free from undesirable side effects. And although marijuana can be habit-forming, it is not as addictive as alcohol, tobacco, oxycodone, cocaine, methamphetamine or benzodiazepines. None of those other drugs are categorized as Schedule I, and alcohol and tobacco are not scheduled at all.

Unlike most other prescription medications, marijuana use is associated with many benefits. For example, in states where marijuana has been legalized, worker’s compensation payments have fallen by an average of 21% among people over 40. Researchers think that this is because marijuana helps workers better manage chronic pain. The use of marijuana for pain management also helps to reduce dependency on opioids. One study found that U.S. counties with one or two marijuana dispensaries had an average of 17% fewer opioid-related fatalities compared with counties with no dispensaries.

Research also shows that marijuana use can help to prevent Alzheimer’s by blocking the enzymes that produce amyloid plaques. It also shows promise for reducing a person’s risk of developing Type 2 diabetes by helping the body regulate insulin and glucose levels.

All of these benefits add up to marijuana users having an overall lower rate of premature death than nonusers.

Chris Meyers, PhD, is an Adjunct Professor of Philosophy at George Washington University. His main area of research is in moral psychology, moral theory, and applied ethics/public policy. Meyers is the author of “Drug Legalization,” a textbook that looks at the pros and cons of prohibiting recreational drugs.

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

Women with Endometriosis Often Miss School and Work Due to Pain

By Dr. Rasha Al-Lami

More than two-thirds of women with endometriosis missed school or work due to pain from the condition, in a study of more than 17,000 women between the ages of 15 and 44 in the U.S. That is a key finding of new research published in the Journal of Endometriosis and Uterine Disorders.

Our study also found that Black and Hispanic women were less likely to be diagnosed with endometriosis compared with white women. Interestingly, women who identified as part of the LGBTQ community had a higher likelihood of receiving an endometriosis diagnosis than heterosexual women.

We used data from the National Health and Nutrition Examination Survey, which is administered by the Centers for Disease Control and Prevention, for the period 2011 to 2019. The survey data use adjusted weights to account for the racial composition of U.S. society, meaning our sample of 17,619 women represents 51,981,323 women of the U.S. population.

We specifically examined factors related to quality of life, such as poverty, education and functional impairment, as well as race and sexual orientation.

Endometriosis is a chronic, often painful condition that affects approximately 10% of reproductive-age women worldwide. It occurs when tissues that would normally line the inner surface of the uterus instead occur outside the uterus, such as on the ovaries or even in distant organs such as the lungs or brain. These abnormally located lesions respond to hormonal changes during the menstrual cycle, causing pain when stimulated by the hormones that regulate the menstrual cycle.

Black and Hispanic Women Less Likely to Be Diagnosed

Our study sheds light on how endometriosis, despite its prevalence, remains underdiagnosed and underresearched. We found that 6.4% of reproductive-age women in the U.S. had an endometriosis diagnosis. More than 67% reported missed work or school, or having been unable to perform daily activities, due to pain associated with endometriosis.

Our study highlights disparities in the diagnosis and management of endometriosis among different racial groups. Black women had 63% lower odds of getting an endometriosis diagnosis, and Hispanic women had 55% lower odds compared with non-Hispanic white women. This disparity may reflect historical biases in health care, pointing to the need for more equitable practices.

In addition, our study underscores the importance of considering women’s health across diverse population subgroups, with particular attention to sexual orientation. We found that non-heterosexual lesbian, gay, bisexual, transgender and queer women had 54% higher odds of receiving an endometriosis diagnosis compared with straight women. Our study was the first to examine endometriosis likelihood among non-heterosexual women at the national level in the U.S.

We found no significant association between endometriosis and other quality-of-life indicators such as poverty, education or employment status, which suggests that the condition affects women across various socioeconomic backgrounds.

Our work adds to the growing body of evidence that Black women are less likely to be diagnosed with endometriosis and that their reported pain symptoms are often overlooked.

Explanations for this inequity include health care bias against minority women and limited access to medical care among Black women. Research also shows that many medical professionals as well as medical students and residents believe that Black women have a lower pain threshold compared with the white population.

This is another possible reason that pain symptoms among Black women with endometriosis get neglected. Researchers from the U.K reported the same findings, attributing these disparities to systemic bias and inequitable medical care.

Another study estimates that the lifetime costs associated with having endometriosis are about $27,855 per year per patient in the U.S., costing the country about $22 billion annually on health care expenditures.

Rasha Al-Lami, MD, is a women’s health researcher at Yale University. 

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

Flawed Mayo Clinic Study Promotes Opioid Myths

By Crystal Lindell

A new study has been released analyzing why patients start taking opioids — but all the research actually does is perpetuate harmful myths about opioids and the patients who use them. 

The study, which was just published in the Journal of Pain, was conducted by researchers from the Mayo Clinic and the National Center for Complementary and Integrative Health. 

The researchers say this is “the first study to present nationally representative rates of incident prescription opioid use.” But it’s the headline from a Mayo Clinic article about the study that clarifies what the authors were actually trying to get at. It reads: “Who is choosing to use prescription opioids?”

“Choosing” – as though patients have any choice about whether or not they use opioids. 

Opioid medications are not sold over the counter, and many doctors today do everything possible to avoid prescribing them. So the idea that any patient can walk into a doctor’s office and “choose” opioids over alternative treatments is wildly naive, at best. 

I’ll go a step further and somewhat defend the doctors here: if a doctor is prescribing opioids in the current opioid-phobia environment, they are not doing it as a first-line treatment. They’ve  already tried non-opioid medications and non-pharmaceutical therapies, which didn’t work.

But let’s take a step back and look at exactly what the authors of the study claim their research found. In a nationwide survey of nearly 10,500 people conducted in 2019 and 2020, about 4% started using prescription opioids. Four percent isn’t much, but it was enough to surprise the researchers.

"One of the things that we noticed is that people are still utilizing opioids as an early resort or first line treatment, before trying non-opioid treatments first, which goes against best practice guidelines in healthcare," said lead author Ryan D'Souza, MD, a Mayo Clinic anesthesiologist. "This is a wake-up call to how high the incidence rate among new users continues to be."

A bit of a jump in my opinion, but let’s go with that. What are these "early resort or first-line” treatments that D’Souza and his co-author want patients to try before resorting to opioids? As they explain: "Nonpharmacologic modalities, over-the-counter medications, and other nonopioid analgesics as initial treatment for pain."

“Nonpharmacologic modalities” means things like physical therapy and cognitive therapy. “Over-the-counter medications and “nonopioid analgesics” means pain relievers like ibuprofen and acetaminophen (Advil and Tylenol) or prescription medications like gabapentin.

Well, I have some great news for the researchers who did this study: Every single patient asking a doctor for opioid pain medication has already tried Advil. 

It’s also worth noting that some of the data was collected in 2020, which is infamous for being a year that greatly disrupted medical care because of COVID. It was the kind of disruption that literally limited how much access patients had to physical therapy and in-person cognitive therapy. So yes, some patients may have resorted to opioids during that time.

Also, physical and cognitive therapy are both significantly more expensive than hydrocodone, even if you have insurance. Both therapies require multiple sessions — sometimes in the same week — and most insurance companies require a copay for each session. So the difference in price can be dramatic, not to mention the cost of time away from work and family to go to appointments. 

The other major flaw in their list of alternatives is that none of them are great at treating pain quickly. Physical therapy may help over a period of weeks or months, but it’s not going to be much help to an arthritis patient who needs to get work on Monday. And there’s little data showing medications like gabapentin are effective at all when it comes to pain. 

In fact, the researchers found that “ineffective pain treatment” was the primary reason people were given a new prescription for opioids. Other leading factors for opioid use are three or more visits to the ER in one year; having four or more painful conditions; and having two or more disabilities.

Anyone with that many strikes against them probably needs opioids, yet the authors are still troubled that “some participants are using opioids… instead of following various best-practice guidelines.”

As is the case for most medical research, both the data collection and the conclusions drawn by the authors seem to have been done with zero input from any actual patients. That’s the foundational problem for the entire study. None of the conclusions factor in real life situations. 

Studies like this one that demonize every single use of opioids would have a lot more sway if there were actually effective opioid alternatives available. As it stands now, patients do not have an option between “an effective, non-addictive pain medication” and “an effective, always addictive pain medication.” 

In reality, the options are usually between “ineffective, non-addictive medication” and “effective and rarely addictive medication.” 

Anyone who’s actually experienced real pain will tell you that when those are the choices, the “effective” medication wins every time. 

It’s so exhausting that we are still dealing with such flawed thinking from the medical community when it comes to opioids. I understand that opioids make an easy villain in healthcare, but opioids are not a magical, always-addictive medication — no matter how many times the medical community tries to convince us otherwise.

I know this because most patients who undergo general anesthesia are routinely given the opioid medication fentanyl — and none of them wake up post-op suddenly addicted to opioids. In fact, most people who take opioids in any setting never develop problematic use.

So we would be wise to remember that the real villain isn’t opioids. It’s the problem they’re trying to address: pain.

Pain Patients More Likely Than Doctors to Favor Greater Access to Cannabis

By Pat Anson

Americans living with chronic pain are significantly more likely to support greater access to cannabis than the physicians who treat them, according to a new survey that found broad support for cannabis education in medical schools.

Rutgers Health surveyed over 1,600 adults with chronic pain and 1,000 physicians in states with medical cannabis programs. The survey results, recently published in JAMA Network Open, show that 71% of  pain patients support federal legalization of medical cannabis, compared to 59% of physicians.

Patients are also more likely to support nationwide legalization of recreational cannabis (55%), compared to about a third of physicians (38%).

"Cannabis is unique in terms of the complicated policy landscape," said lead author Elizabeth Stone, PhD, an Instructor at Rutgers Robert Wood Johnson Medical School. "Depending on what state you're in, it could be that medical cannabis is legal, it could be that medical and recreational use are legal, it could be that neither is legal, but some things are decriminalized.”

Currently, 38 states and Washington, DC have legalized medical cannabis and 23 of those states (plus DC) have legalized its recreational use. Cannabis remains illegal under federal law as a Schedule I controlled substance, but the DEA is considering a proposal from the Biden Administration to reclassify cannabis as Schedule III substance, which would allow for limited use of cannabis-based medication.

Personal experience plays a significant role in shaping attitudes about cannabis. The Rutgers survey found that people who used cannabis for chronic pain had the highest levels of support for expanding access, while physicians who don’t recommended cannabis for pain management had the lowest levels of support.

Although they have different attitudes about legalization, about 70% of patients and physicians favor requiring medical schools to train future doctors on cannabis treatment of chronic pain. There is also broad support for training that would allow physicians and nurse practitioners to recommend cannabis to their patients.  

"I think it points to the need for future guidance around cannabis use and efficacy," Stone said. "Is it something they should be recommending? If so, are there different considerations for types of products or modes of use or concentration?"

Nearly two thirds of patients (64%) and about half of physicians (51%), favor requiring insurance companies to cover cannabis treatment of chronic pain.

Support for Cannabis Policies

JAMA NETWORK OPEN

Previous surveys have also found distinct differences in patient and physician attitudes about cannabis. A recent survey of primary care doctors found that nearly one in five (18%) would not accept a new patient using medical cannabis. And 40% said they would not accept a patient using non-medical or recreational cannabis.

Many doctors are worried what their colleagues will think or what law enforcement will do if they prescribed or recommended cannabis. A 2019 survey of oncologists and pain management specialists found that nearly two-thirds (65%) were concerned about the legal repercussions of recommending medical cannabis to their patients. And 60% were worried about professional stigma.

Many patients who live with chronic pain are turning to cannabis as an alternative to opioids. A recent PNN survey found that over 30% of pain patients said they had used cannabis for pain relief. Many did so because they couldn’t get an opioid prescription or had problems getting one filled.

The Whims of Pharmacy Pricing

By Crystal Lindell

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

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

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

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

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

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

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

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

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

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

She insisted there was nothing they could do about it. 

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

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

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

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

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

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

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

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

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

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

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

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

Muscle Relaxants Ineffective for Low Back Pain and Fibromyalgia

By Pat Anson

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

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

• Carisoprodol (Soma)

• Baclofen

• Tizanidine

• Cyclobenzaprine

• Eperisone

• Quinine

• Orphenadrine

• Chlormezanone

• Methocarbamol

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

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

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

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

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

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

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

Survey Finds Patients and Doctors Unsatisfied with Treatments for Acute Pain

By Pat Anson

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

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

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

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

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

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

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

• 70% Limited their ability to walk and exercise

• 69% Limited their sleep

• 65% Limited their hobby or leisure activity

• 65% Made them feel irritable or emotionally drained

• Missed an average of 19 work days annually

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

• 49% of patients concerned about opioid addiction

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

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

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

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

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

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

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

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

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

Eilish, Dunham, Jamil: How Ehlers-Danlos Celebrities Raise Awareness and Scrutiny

By Crystal Lindell

I have to confess that I never watched the HBO Show Girls. It’s not that it looks like a bad show. In fact, almost the opposite. It sounds like a good show. 

But as a young millennial flailing through life when Girls premiered in 2012, I worried that I’d see myself — including my flaws — reflected back at me. And I just have never been in a place, mentally, to process that kind of personal attack. So I didn’t watch Girls.

When the show’s top star and creator Lena Dunham later revealed that she had the same health condition as me — Ehlers-Danlos Syndrome (EDS) — it only worked to confirm my fears. 

A lot of people hate Lena Dunham, and a lot of people also hate the character she played on Girls.

What if, through watching the show, I discover that I am like her?

What if I start to believe that I’m worthy of the same level of hate? And in the process, I start to hate myself?

After I was diagnosed with EDS in 2018, Dunham was among the first celebrities I remember seeing reveal her own diagnosis publicly. 

In the fall of 2019, Dunham posted unflattering paparazzi pictures of herself to Instagram — including one of her in a blue granny nightgown, holding a cane in one hand and a cellphone in the other.

LENA DUNHAM

“I could choose to be embarrassed by these paparazzi pics — I mean, that’s probably the point of someone publishing them in the first place — but I’m really not,” Dunham wrote.

“I could lie and say it was an early Halloween look… But the truth is just: This is what life is like when I’m struggling most with chronic illness. An Ehler-Danlos syndrome flare means that I need support from more than just my friends... so thank you, sweet cane!”

A lot of the online EDS community did not take the news well. 

One Reddit user wrote at the time: “Lena Dunham is an extremely problematic and troubled individual. If there is ANY celebrity whose claims — not just regarding illness but regarding all facets of autobiography — should be looked at with a critical and cautious eye, it’s her. She’s not someone we should, as a community, try to turn into a role model or representative for EDS.”

The sentiment summed up what a lot of EDS patients were saying on the internet at the time.

Finally, a celebrity bringing awareness to EDS, and I couldn’t even be excited about it? Instead, I worried that the people who hated her would now hate me too.

JAMEELA JAMIL

The other big name to reveal her EDS diagnosis in 2019 was Jameela Jamil.

And, unfortunately, she’s another celebrity who a lot of people love to hate. 

Two celebrities were out there spreading awareness about the very condition that has caused me immense health problems my entire life, but I couldn’t even post about it online without worrying about haters.

Over the years, a number of other celebrities have also revealed that they have EDS or a related hypermobility disorder, including: Selma Blair, Halsey, Sia, Cherylee Houston, Yvee Oddly and others. 

‘Been in Pain Since I Was Nine’

Most recently, Billie Eilish discussed her hypermobility, a condition often seen as related to EDS, in a recent Vogue profile. At times, she feels like she was at war with her own body.

“I’ve basically been in pain since I was nine,” said Eilish. “Growing up, I’d always hear people be like, ‘Just wait until you’re older! You’re going to have so much pain!’ And I remember being so furious.” 

Bringing EDS into the mainstream and creating awareness should, in theory, help more suffering patients get the diagnosis they seek. Ideally, it would also help lead to more research into the condition, including treatments and maybe even a cure. 

In a perfect world, increased awareness would also lead to more compassion for those struggling with the often painful symptoms of EDS. 

Sadly, over the years, I’ve watched the opposite often happen instead. As EDS has become more well-known, a lot of people have started to see EDS as a trendy diagnosis, the type patients want because they saw that a celebrity has it. 

BILLIE EILISH

In fact, a few years after I was diagnosed at a university hospital, I had a different medical specialist at the same university walk into the exam room and greet me for the first time with, “So what makes you think you have EDS?” 

He asked me as though I had Googled “EDS” on the way to the appointment and then decided to add it to my intake form on a whim. 

In fact, that’s been one of the most jarring things about having EDS. The condition has very obvious visual markers, but people will still try to claim it’s fake. 

My elbow extends way past the normal range of motion. You can’t fake that. 

Every celebrity I’ve seen who’s revealed their own EDS diagnosis has seemed intent on making sure that it is not seen as the most defining thing about them. It’s a truly understandable goal. I don’t want EDS to define me either. 

Unfortunately, EDS has started to be defined by the celebrities who have it: “That Lena Dunham-Jameela Jamil thing.” For better — and sometimes worse — they end up representing our condition in the eyes of the general public. 

While most EDS celebrities don’t have a slew of hate-fans behind them, none of them are fully beloved by the public. And, of course, that’s because being fully beloved by the public is impossible for any human being. 

In fact, all of us are flawed. So in that sense, EDS celebrities are just like us! 

How to Inhibit Reactivation of the Epstein-Barr Virus

By Dr. Forest Tennant

The Epstein-Barr virus (EBV) is a parasite that normally lives a dormant, harmless life in nasal and throat membranes and in our white blood cells. We are all carriers of EBV.

EBV usually enters the body and first activates during infancy, often resulting in a case of the "sniffles." In teenagers or young adults, it may trigger infectious mononucleosis. After the initial infection, the virus becomes dormant.

Unfortunately, EBV has the ability to reactivate, duplicate, and travel in the blood inside lymphocytes (white blood cells) to harm tissues and cause pain. How does this happen?

Biologic stress, meaning a physical or psychological situation that cause the hormones cortisol and adrenaline to elevate for more than a few hours, may lower one's immune system. That gives EBV the opportunity to reactivate, produce auto-antibodies, infiltrate tissue, and silently produce a painful condition.

The usual stressors that cause reactivation are physical trauma or injury, an infection, or emotional distress. People with medical conditions such as a genetic connective tissue disease (Ehlers-Danlos syndrome), diabetes, or stroke may have an immune deficiency that also makes them more prone to EBV reactivation.

EBV reactivation is similar to herpes or shingles reactivation. Like EBV, herpes and shingles are usually dormant and harmless viral infections, but they may reactivate and cause blisters or a skin rash.  

Unfortunately, EBV reactivation can be totally asymptomatic and unknown to the individual, until chronic reactivations cause a painful condition. This could result in fibromyalgia, small fiber neuropathy, burning mouth, herniated disc, arachnoiditis or even a cancer such as Hodgkin's disease or lymphoma. 

How to Diagnose and Treat EBV Reactivation

Persons with chronic pain severe enough to require daily pain relief medication may have EBV reactivation as a cause of their condition and should take steps to inhibit it. We recommend antibody testing for EBV reactivation in any person who has severe chronic pain for over 90 days and needs to take pain relievers daily.

Two antibodies are formed during EBV reactivation: the Viral Capsid Antibody (VCA) and Epstein-Barr Nuclear Antibody (EBNA).

Major laboratories offer three quantitative tests for VCA, EBNA and early EBNA antibodies. Qualitative tests (positive or negative) are not specific enough to make a diagnosis of EBV reactivation.

When VCA and EBNA antibodies are elevated above normal levels, a diagnosis of past reactivation is made, and the individual can properly be called a "chronic reactivator." We recommend that levels of VCA and EBNA be two or more times above normal, plus a patient having pain in two or more anatomic sites, to warrant a diagnosis of EBV reactivation.

If the early EBNA antibody is elevated above normal, therapeutic trials of antivirals and corticosteroids should be considered to reverse reactivation.

If both VCA and EBNA are elevated but the early EBNA is negative, we recommend the use of these vitamins and supplements to inhibit EBV reactivation:

• Vitamins C and D

• Astragalus

• Zinc

• Resveratrol

• Curcumin

• Selenium

• Luteolin

• Andrographis

• Lysine

Our research has found that about 90% of patients with adhesive arachnoiditis (AA) have EBV reactivation.  The good news is that once it is determined that a person has reactivation and autoimmunity, there are simple treatment measures that can be implemented.   

In our experience, the treatment measures tend to provide about 20% to 50% more pain relief when used with standard pain therapies. Failure to take therapeutic measures to control EBV may allow increased disease deterioration and pain. 

More information about the Epstein-Barr Virus and its relationship to chronic pain conditions can be found in our new book: "The Epstein-Barr Virus: A New Factor in the Care of Chronic Pain."  

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 this research should visit the Tennant Foundation’s website, Arachnoiditis Hope. You can also subscribe to its bulletins here.   

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

Racial Myths About Pain Are Embedded in Artificial Intelligence

By Crystal Lindell

A new study published in JAMA found that artificial intelligence (AI) programs are encoded with racial and ethnic biases – just like humans – when it comes to evaluating a patient's pain. 

The authors said they wanted to look into the issue because it's already well-known that doctors underestimate and undertreat black patients’ pain compared to white patients. 

To study how that may impact AI, researchers had 222 medical students and residents evaluate two different patients, one black and one white, who were both experiencing pain. They also had them evaluate statements about how race may impact biology, some of which were myths and some of which were true. 

Then the researchers had two Large Language Models (LLMs) widely used in AI — Gemini Pro  and GPT-4 — do the same by feeding them patient information reports, and then having them evaluate statements about how race impacts biology. 

There wasn’t much difference between the humans and the AI models when it came to rating patients’ pain, regardless of race. Both the humans and the AI models rated the patients as having similar pain scores. 

However, both the humans and AI systems had some false beliefs about race and patient pain. Gemini Pro fared the worst, while GPT-4 and the humans came out relatively similar. 

Specifically, Gemini Pro had the highest rate of racial myths (24%). That was followed by the humans (12%) and GPT-4 (9%).

“Although LLMs rate pain similarly between races and ethnicities, they underestimate pain among Black individuals in the presence of false beliefs,” wrote lead author Brototo Deb, MD, a resident at Georgetown University–MedStar Washington Hospital Center.

“Given LLMs’ significant abilities in assisting with clinical reasoning, as well as a human tendency toward automation bias, these biases could propagate race and ethnicity–based medicine and the undertreatment of pain in Black patients.”

Deb and co-author Adam Rodman, MD, says their study corresponds with previous research showing that AI models have biases related to race and ethnicity. 

Given how AI is increasingly used in clinical practice, there’s concern that black patients’ pain will continue to be undertreated, making them less likely to get opioids and more likely to be drug tested. 

There’s a common belief that AI will eliminate racial bias because computers are seen as more logical than humans. However, AI is encoded with data provided by humans, which means as long as humans have bias, AI will too. 

The real problem is if doctors start to rely too much on AI for patient evaluations, there’s a potential for real harm. Especially if doctors use AI to justify their medical decisions under the false belief that they are unbiased. 

It’s still unclear how these new AI systems will impact healthcare, but everyone involved should be careful to avoid relying too heavily on them. At the end of the day, just like the humans who program them, AI models have their flaws. 

Poppy Seeds Draw More Scrutiny for Addiction Risk

By David Hilzenrath, Healthbeat

It sounds like a joke: poppy seeds infused with opioids.

Indeed, it was a plotline on the sitcom Seinfeld. But for some it has been a tragedy. People have died after drinking tea brewed from unwashed poppy seeds.

And after eating lemon poppy seed bread or an everything bagel, mothers reportedly have been separated from newborns because the women failed drug tests.

Poppy seeds come from the plant that produces opium and from which painkillers such as morphine and codeine are derived. During harvesting and processing, the seeds can become coated with the opium fluid.

Members of the House and Senate have proposed legislation “to prohibit the distribution and sale of contaminated poppy seeds in order to prevent harm, addiction, and further deaths from morphine-contaminated poppy seeds.” The bill was one of several on the agenda for a Sept. 10 House hearing.

The day before the hearing, The Marshall Project and Reveal reported on a woman who ate a salad with poppy seed dressing before giving birth, tested positive at the hospital for opiates, was reported to child welfare, and saw her baby taken into protective custody. Almost two weeks passed before she was allowed to bring her baby home, the story said.

“It’s not an urban legend: Eating poppy seeds can cause diners to test positive for codeine on a urinalysis,” the Defense Department warned military personnel in 2023.

The U.S. Anti-Doping Agency long ago issued a similar warning to athletes.

The Center for Science in the Public Interest, a watchdog group, petitioned the FDA in 2021 to limit the opiate content of poppy seeds. In May, after more than three years with no response, it sued the agency to force action.

“So far the FDA has been negligent in protecting consumers,” said Steve Hacala, whose son died after consuming poppy seed tea and who has joined forces with CSPI. The lawsuit was put on hold in July, after the FDA said it would respond to the group’s petition by the end of February 2025.

The FDA did not answer questions for this article. The agency generally does not comment on litigation, spokesperson Courtney Rhodes said.

A 2021 study co-authored by CSPI personnel found more than 100 reports to poison control centers between 2000 and 2018 resulting from intentional abuse or misuse of poppy seeds, said CSPI scientist Eva Greenthal, one of the study’s authors.

Only rarely would baked goods or other food items containing washed poppy seeds trigger positive drug tests, doctors who have studied the issue said.

It’s “exquisitely doubtful” that the “relatively trivial” amount of morphine in an everything bagel or the like would cause anyone harm, said Irving Haber, a doctor who has written about poppy seeds, specializes in pain medicine, and signed the CSPI petition to the FDA.

Unwashed Seeds More Potent

On the other hand, tea made from large quantities of unwashed poppy seeds could lead to addiction and overdose, doctors said. The risks are heightened if the person drinking the brew is also consuming other opioids, such as prescription pain relievers.

Benjamin Lai, a physician who chairs a program on opioids at the Mayo Clinic in Rochester, Minnesota, said he has been treating a patient who developed long-term opioid addiction from consuming poppy seed tea. The patient, a man in his 30s, found it at a health food store and was under the impression it would help him relax and recover from gym workouts. After a few months, he tried to stop and experienced withdrawal symptoms, Lai said.

Another patient, an older woman, developed withdrawal symptoms under similar circumstances but responded well to treatment, Lai said.

Some websites tout poppy seed tea as offering health benefits. And some sellers “may use specific language such as ‘raw,’ ‘unprocessed,’ or ‘unwashed’ to signal that their products contain higher concentrations of opiates than properly processed seeds,” the CSPI lawsuit said.

Steve Hacala’s son, Stephen Hacala, a music teacher, had been experiencing anxiety and insomnia, for which poppy seed tea is promoted as a natural remedy, the lawsuit said. In 2016, at age 24, he ordered a bag of poppy seeds online, rinsed them with water, and consumed the rinse. He died of morphine poisoning.

The only source of morphine found in Stephen’s home, where he died, was commercially available poppy seeds, a medical examiner at the Arkansas State Crime Lab said in a letter to the father. The medical examiner wrote that poppy seeds “very likely” caused Stephen’s death.

Steve Hacala estimated that the quantity of poppy seeds found in a 1-liter plastic water bottle in his son’s home could have delivered more than 10 times a lethal dose.

Steve Hacala and his wife, Betty, have funded CSPI’s efforts to call attention to the issue. (The publisher of KFF Health News, David Rousseau, is on the CSPI board.)

The lawsuit also cited mothers who, like those in the investigation by The Marshall Project and Reveal, ran afoul of rules meant to protect newborns. For example, though Jamie Silakowski had not used opioids while pregnant, she was initially prevented from leaving the hospital with her baby, the suit said.

Silakowski recalled that, before going to the hospital, she had eaten lemon poppy seed bread at Tim Hortons, a fast-food chain, CSPI said in its petition. “No one in the hospital believed Ms. Silakowski or appeared to be aware that the test results could occur from poppy seeds.”

People from child protective services made unannounced visits to her home, interviewed her other children, and questioned teachers at their school, she said in an interview.

While on maternity leave, she had to undergo drug testing, Silakowski said. “Peeing in front of someone like I’m a criminal — it was just mortifying.”

Even family members were questioning her, and there was nothing she could do to dispel doubts, she said. “Relationships were torn apart,” she said.

The parent company of Tim Hortons, Restaurant Brands International, which also owns Burger King and Popeyes, did not respond to questions from KFF Health News.

In July, The Washington Post reported that Trader Joe’s Everything but the Bagel seasoning was banned and being confiscated in South Korea because it contains poppy seeds. Trader Joe’s did not respond to inquiries for this article. The seasoning is listed for sale on the company’s website.

The U.S. Drug Enforcement Agency says unwashed poppy seeds can kill when used alone or in combination with other drugs. While poppy seeds are exempt from drug control under the Controlled Substances Act, opium contaminants on the seeds are not, the agency says. The Justice Department has brought criminal prosecutions over the sale of unwashed poppy seeds.

Meanwhile, the legislation to control poppy seed contamination has not gained much traction.

The Senate bill, introduced by Sen. Tom Cotton (R-Ark.), has two co-sponsors.

The House bill, introduced by Rep. Steve Womack (R-Ark.), has none. Though it was on the agenda, it didn’t come up at the recent hearing.

Healthbeat is a nonprofit newsroom covering public health published by Civic News Company and KFF Health News, a national newsroom that produces in-depth journalism about health issues.  

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

By Pat Anson

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

That discrepancy hasn’t been lost on pain sufferers.

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

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

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

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

Peer Reviewers of Medical Studies Have Conflicts of Interest

By Crystal Lindell

How much are medical studies impacted by financial conflicts of interest? New research shows the problem may run deeper than most people realize. 

The authors of peer-reviewed studies in medical journals usually have to disclose whether or not they received money from pharmaceutical companies or medical device manufacturers. But new research published in JAMA looks at the next layer: the peer reviewers themselves.

Due to the “traditionally opaque nature of peer review,” it’s difficult to investigate the issue, but an international team of researchers studied peer reviewers at high-impact medical journals like The BMJ, JAMA, The Lancet, and The New England Journal of Medicine.

They looked specifically at nearly 2,000 U.S-based physicians who served as peer reviewers. 

What they found is both unsurprising and alarming. Between 2020 and 2022, more than half (58.9%) of the peer reviewers analyzed had received at least one industry payment. In total, the peer reviewers received a staggering $1.06 billion in industry payments. 

It should be noted that companies don’t spend that kind of money out of some noble love of medicine. No, they are doing it because it helps increase their profits or advances their interests. 

Most of that money – $1 billion or 94 percent – was paid directly to individuals or to their institutions to help fund research programs. That’s why academics who churn out studies are highly prized at universities and research institutes.

The rest of the money – $64.18 million – was in the form of general payments, which includes everything from speaker fees and “honoraria” to food, drink, lodging and travel expenses. 

The median general payment to a peer reviewer was $7,614, while the median research payment was $153,173. 

Interestingly, the average male reviewer had a significantly higher total payment ($38,959) than the average female reviewer ($19,586). 

The authors also broke down differences between medical specialties. Doctors who specialize in cardiology, rheumatology, oncology, immunology or addiction treatment were the most likely to get payments (73.5%), followed by surgeons (72%), psychiatrists (65%), hospital-based specialists (47%) and primary care physicians (38%).

Those results shed light on which fields of medicine may be more susceptible to conflicts of interests.

The study’s authors came to the only conclusion that makes sense given all this data: "Additional research and transparency regarding industry payments in the peer review process are needed."

I agree that this is clearly an issue that needs to be addressed. But we shouldn’t have to wait for more research to start taking action. We need stronger policies at medical journals to help contain the potential harm it’s causing. 

At the very least, peer reviewers should have to disclose conflicts of interest. While that may conflict with the policy of some journals to keep peer reviewers anonymous, given the potential for bias and other negative consequences, it seems the financial disclosures should take precedence. 

Since peer reviewers also have the ability to reject research before it’s even published, they should have their names and potential conflicts listed in the publications. 

Beyond that, medical journals need to start having difficult conversations about whether peer reviewers should even be allowed to review studies that involve companies or industries that pay them. 

While it may not be entirely possible in our for-profit healthcare system, that doesn’t mean it shouldn’t be explored. After all, the study did not find that 100% of peer reviewers accepted payments. So clearly some peer reviewers found a way to do the work without an obvious conflict of interest.

It isn’t just medical journals that do a poor job flagging the conflicts of peer reviewers. When PNN made a Freedom of Information Act (FOIA) request to the CDC seeking more information about the “Core Expert Group” involved in the agency’s 2016 opioid guideline, most of the documents we received back were heavily edited or redacted.

The CDC’s FOIA office said the group was exempt from our request because of “deliberative process privilege” and that disclosing their conflicts would have been “a clearly unwarranted invasion of personal privacy.”  

Why Conflicts Matter

Why do conflicts of interest matter? The easiest way to understand it is that whenever money is involved, it can potentially lead to what is essentially a boss-employee power dynamic. And typically, people don’t like to upset their bosses. 

Intuitively, most people also understand that if a medical device company funds medical device research, the researchers are incentivized to manipulate both the research methods and results in hopes of providing the funder the results they seek. 

Sometimes it’s deliberate, but sometimes it just happens on a subconscious level. People naturally favor people who give them money. However, in this case, the result of that favoritism could harm the health of millions of patients. 

In one high-profile example from 2018, a top cancer researcher failed to disclose the millions of dollars in payments he received from drug and healthcare companies.

As ProPublica and The New York Times reported, Dr. José Baselga, then-chief medical officer at Memorial Sloan Kettering Cancer Center in New York, had a number of undisclosed conflicts of interests. 

One such conflict may have led Baselga to put a positive spin on the results of two Roche-sponsored clinical trials — trials that many others had considered disappointments. He did this without disclosing the more than $3 million in consulting fees he’d received from Roche. He also left out that he had a stake in a company Roche had acquired. 

Baselga resigned just days after the news investigation came out, but journalists just don’t have the resources to constantly investigate every single researcher for conflicts of interest. That’s why medical journals must regulate the issue themselves. 

Yes, most medical journals already have policies requiring study authors to disclose conflicts of interest, but as this new research makes clear, that’s not enough. It’s past time for peer reviewers to be required to do the same. 

After all, it’s not just because the public deserves to know. Our lives could depend on it. 

Do You Hurry to Outrun the Pain?

By Carol Levy

I'm infused with impatience. I do everything fast.

I used to swim at the YMCA. I didn’t feel like I was moving quickly, but to others I was a speeding bullet knifing through the water. As soon as I stopped, to make my turn at the end of the lane, invariably someone watching would yell down at me, “What's your rush? Isn't it more fun if you enjoy it?”

Not for me. It's not just the physicality of moving swiftly through the water, which for me is a wonderful feeling. More important is getting to the end of the mile of swimming I try to complete, before something happens to trigger my pain.

I can't tolerate touch to the left side of my face, due to trigeminal neuralgia and phantom pain. Just the idea of a droplet of water touching my face terrorizes me, so I only do the backstroke.

One day a man asked me, “Is that the only stroke you know? I could teach you others.”

I didn't want to explain why I only did the backstroke, so I shrugged my shoulders and swam away. 

The backstroke works for me because my arms move in such a way that they don't fire off bullets of water that might hit my face. Regardless, I am always at the mercy of the thought, “Be careful! Finish this before you get hit in the face with a droplet.”

I'm impatient because I have to outrun the pain. I get to the Y early, impatient to get into the pool before others, so no one gets in the lanes next to me and splashes water on my face.

This is true of almost every aspect of my life. I shop fast because using my eyes too much triggers the pain. The faster I go through a store, the less opportunity I have to see things I want to see, but did not come to buy.

On rare occasions, I get sidetracked.  I forget.  I start to look at what else they have. My eyes start to travel up and down the shelves, and the pain grows to such heights that I fear my ability to get out of the store and drive home safely. So, I rush.

Before my trigeminal neuralgia, I loved to read. I could read a whole book in a few hours. And as soon as I finished, like the joke about eating Chinese food, I'd be hungry to start a new one.

Now I can read only a few pages at a time, skipping words, paragraphs, pages, looking for the dialogue that essentially explains the story. Who the main characters are and what their relationships are with each other, are lost to me.

I am impatient to get to the end. Not to see who the murderer is (I love mysteries the best), but to get to the end quickly, so the pain doesn't interfere.

I could go on and on with other examples, but they don't matter. At the end of the day, they all boil down to one thing: Hurry up! Hurry up! The pain is coming! The pain has started!

But I have to get to the end. The end of the swimming lane, the grocery list, and the end of the book.

There are changes we all go through, no matter our circumstances. But I think pain sufferers change more than most people -- and the changes are largely the result of trying to outrun the pain. It’s an impatience that’s very hard for those without pain to understand.

As for me? I used to be the tortoise. Now I'm the hare. Right now, I'm hurrying to finish writing this column before the pain takes over from using my eyes so much.

Pain makes me rabbit my way through life. The tortoise, ambling by, gets to look at the scenery. The hare in us makes it hard to stop and smell the roses.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.