Cheap Migraine Drugs More Effective Than New Expensive Ones

By Pat Anson

Migraine treatment drugs known as triptans are more effective in relieving acute migraine pain than new expensive medications and should be used more widely, according to new study published in The BMJ.

A team of researchers at Oxford University analyzed the results from 137 clinical studies to see which migraine drugs were more effective in helping patients become pain-free after two hours and whether that relief was sustained 24 hours later. Nearly 90,000 people participated in the studies, over 85% of them women.

Four triptans - eletriptan, rizatriptan, sumatriptan, and zolmitriptan – were rated the best overall, ahead of rimegepant (Nurtec), ubrogepant (Ubrelvy) and lasmiditan (Reyvow) in efficacy and tolerability.

“Overall, the results of our network meta-analysis suggest that the best performing triptans should be considered the treatment of choice for migraine episodes owing to their capacity for inducing rapid and sustained pain freedom, which is of key importance for people with migraine,” wrote lead author Andrea Cipriani, MD, a professor of psychiatry and director of the Precision Psychiatry Lab at Oxford.

Triptans work by narrowing blood vessels in the brain and preventing the release of chemicals that cause migraine pain; while rimegepant and ubrogepant inhibit calcitonin gene-related peptides (CGRPs), a protein that triggers pain. Lasmiditan reduces pain by binding to serotonin receptors in the brain.

The drugs’ mechanisms of action are different and so is their cost. A packet of 6 tablets of eletriptan costs about $106, while a similar-sized packet of rimegepant (Nurtec) costs $1,061; ubrogepant (Ubrelvy) costs $1,097; and lasmiditan (Reyvow) is priced at $790. The cost of those three drugs is much higher because they are only available as brand name medications, while triptans are widely available in cheaper generic formulations.

Despite their cost and extensive marketing promoting their use, lasmiditan, rimegepant, and ubrogepant were rated no more effective in treating migraine pain than over-the-counter drugs such as acetaminophen (paracetamol) and non-steroidal anti-inflammatory drugs (NSAIDs). Researchers say those OTC pain relievers should be considered second line options, if triptans are ineffective.  

“While the recent introduction of lasmiditan, rimegepant, and ubrogepant has expanded options for the acute treatment of migraine, the high cost of these newer drugs, along with the substantial adverse effects of lasmiditan (dizziness), suggest their use as third line options, after the less expensive, similarly efficacious, second line options,” researchers said.

“Limited access to triptans and their substantial under-utilization represents missed opportunities to offer more effective treatments and deliver better quality of care to people who experience migraine.”

Some people can’t take triptans due to cardiovascular problems or unwanted side effects, but researchers say the best performing triptans should be included in the World Health Organization’s List of Essential Medicines to help expand their use.

Another recent study also rated triptans as superior to other migraine medications, although that research didn’t include the newer CGRP inhibitors.

Migraine affects about 39 million people in the United States and 1.1 billion worldwide. In addition to headache pain, migraine can cause nausea, blurriness, and sensitivity to light or sound. Women are three times more likely to suffer from migraines than men.  

Youths with Chronic Pain More Likely to Have Anxiety and Depression

By Crystal Lindell

Young people with chronic pain are more likely to suffer from anxiety and depression, according to new research published in JAMA Pediatrics.

Researchers in the U.S. and Australia reviewed 79 previous studies involving over 12,600 youths with chronic pain. The average age was about 14. Many live with chronic illnesses such as juvenile idiopathic arthritis, fibromyalgia, Crohn’s disease and colitis. 

The research team found that 34.6% had an anxiety disorder and 12.2% had depression. Those rates are more than 3 times higher than what is normally seen in a community setting.

Researchers say mental health screening, prevention and treatment should be a priority for young people with chronic pain. 

“A simple way to put this into practice would be for pain practitioners to consider a short screening assessment for symptoms of anxiety and depression in young patients,” said lead author Joanne Dudeney, PhD, a clinical psychologist and research fellow at Macquarie University in Australia.

“This is a vulnerable population, and if we’re not considering the mental health component, it’s likely we’re also not going to achieve the clinical improvements we want to see.”

The findings are surprising to me because I would have expected the rates of anxiety and depression to be even higher. Chronic pain is depressing, and it’s also natural that dealing with it would cause anxiety. Plus, the teenage years are infamous for being a hotbed of intense emotions – even for those who aren’t dealing with physical ailments. 

So if you had asked me to guess how many teens with chronic pain had depression and/or anxiety, I would have said something closer to 95 percent. It’s a wonder how anyone with chronic pain is not depressed or anxious. 

Regardless, I’m always glad to see more data like this, validating the experiences of those of us with chronic pain – especially when it comes to younger patients. Anyone who is more likely to suffer from mental health problems should be screened for them so they can get treatment.

Many doctors try to blame pain symptoms on depression and anxiety, so I always worry that research like this will somehow be used against patients. I could easily see doctors focusing on the mental health issues associated with chronic pain more than the physical ones after reading this study. 

The more hopeful scenario though is that this type of research is instead used to save lives and to make being alive easier for young pain patients. If more mental health screenings are able to prevent and treat depression, anxiety, and coping behaviors like self-harm, drug use and even suicidal ideation, that would be incredible. 

If you’re young and dealing with chronic pain, depression and/or anxiety, I want you to know that I am out here rooting for you. Your life matters in ways you can’t even fully grasp yet, and we need you to keep going. The world is a better place with you in it.

New Documentary Explores Benefits and Risks of Kratom

By Pat Anson

If you’ve heard about kratom and wondered if the herbal supplement might be useful in treating chronic pain, you’ve probably been struck by the wide range of opinions about it.  

“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use,” said former FDA Commissioner Scott Gottlieb.

“Kratom has truly not only saved my life but also given me renewed hope. Without this plant I do not believe I would still be alive today,” said kratom user Kim DeMott.  

“The drug looks similar to brown powdered kratom, produces similar effects as heroin, and is primarily used… by people addicted to heroin,” reports the Ohio Substance Abuse Monitoring Network.

“Kratom does not make me high, nor do I experience side effects. I am now clear minded without the sedation caused by narcotics,” said Mary Ann Dunkel, one of the estimated two million Americans who use kratom, despite warnings that it is an “emerging public health threat.”  

If you’re confused by these diametrically opposed views, you’re not alone. Which is why Steve Hamm produced and directed a new 80-minute documentary called “The Mysteries of Kratom.”  

Hamm knew little about kratom until he started chatting with a neighbor, Dr. Marek Chawarski, a Professor of Psychiatry and Emergency Medicine at Yale School of Medicine. Chawarski spent years studying kratom in Southeast Asia, where it has been used for centuries as a natural stimulant and pain reliever.

“When Marek started talking about kratom and just the potential of it being used as an analgesic, as a painkiller, and potentially being used in dealing with opioid addiction. I got really interested,” Hamm explained. “Ultimately, we decided to make this film by asking a core question. Could a leaf of a tree in Southeast Asia help us solve this terrible addiction problem that we have in the US?”

The resulting documentary by Elm City Films is mostly self-funded and takes an even-handed, journalistic approach to the subject. You’ll hear from a grieving mother who believes her son overdosed on kratom, and a pain patient who says kratom is safer and more effective than opioids.

Hamm spent a month with Chawarski in Southeast Asia, learning how kratom is grown, cultivated and used. People there prefer using fresh kratom, either by chewing the leaves or using them to make a tea. Reports of kratom abuse or addiction are rare.

“I have not seen, nor have I heard, of any fatal overdoses from kratom in Malaysia. Non-fatal, there could be possibilities of it, but again there is no documented evidence,” said Vicknasingan Kasinather, a Malaysian professor and kratom researcher

Due to growing demand in the United States, kratom has become an important cash crop in Malaysia, Thailand and Indonesia. Most of it is dried and processed before being exported, and that processing could be where some contaminants and chemicals are first introduced.  

Once it is shipped overseas, some kratom vendors take the powder and create potent synthetic extracts using an alkaloid called 7-mitragynine, which was recently implicated by the FDA in at least one fatal overdose.

“I was recently at a trade show, where a lot of kratom products are being displayed, and I see these vendors now developing novel new products, including vape pens with 7-mitragynine that by nature are dangerous. They also have 7-mitragynine extracted powders,” said Mac Haddow, a lobbyist for the American Kratom Association. “Those should be banned from the marketplace because they are not natural, they’re synthetically derived, and that’s a real threat to the public.”

Kratom products, like other dietary supplements, are only loosely regulated by the FDA. Many kratom advocates say more regulation is needed, with testing and labeling a better alternative than an outright ban on kratom, which the FDA and DEA tried unsuccessfully to impose in 2016.

“I think the more laws there are about labeling kratom products, the better. Because then there’s more information that gets out there to the consumer,” says Brian Gallagher, a kratom podcaster.  “If it was banned everywhere, then you’d go from a grey market to a black market, where there’s no regulation. We have maybe half the companies doing the right thing. When kratom is banned, zero companies will be doing the right thing.”

Hamm hopes his documentary will help people come to a better understanding of kratom’s risks and benefits, and how a simple leaf could be a solution to some of our biggest health problems.

“We look at the science, we look at the people, we look at the legal issues and the controversies that are there. We hope you all enjoy the film, and we hope it will spark a new conversation about kratom, but also about opioids,” he said..

Study Finds Link Between Belly Fat and Chronic Pain, but Which Causes Which?

By Crystal Lindell

A new study shows a link between abdominal fat and chronic musculoskeletal pain, but even the authors admit that it’s unclear which one causes which. 

The study, published in the American Society for Regional Anesthesia & Pain Medicine, found that abdominal adipose tissue (fat) is associated with chronic pain in multiple sites and widespread chronic pain. It also found that women were at higher risk for this association than men. 

“Reducing abdominal adiposity may be considered a target for chronic pain management, particularly in those with pain in multiple sites and widespread pain," wrote lead author Feng Pan, PhD, Senior Research Fellow at the Menzies Institute for Medical Research in Australia. “The identified stronger effects in women than men may reflect sex differences in fat distribution and hormones.”

In layman's terms, they’re suggesting that chronic pain patients be told to lose weight. Especially if they are women.

However, further down in the study, while discussing its limitations, they admit that the research does not “address the issue of potential bidirectional causality.” In other words, they cannot say whether excess abdominal fat causes chronic pain, or whether chronic pain causes excess abdominal fat. 

The researchers looked at health data from 32,409 people taking part in the UK Biobank study, a large research study with half a million UK participants.

The study used MRI images to measure visceral adipose tissue (VAT), which is fat that surrounds the organs in the abdominal cavity, such as the liver, stomach and intestines. They also measured subcutaneous adipose tissue (SAT), the layer of fat that sits between the skin and muscles in the body. 

Participants were asked if they had pain in a specific area of their body or all over their body for more than three months. 

Two years later, all the assessments were carried out again in 638 people in the group.

The results showed that the more fat people carried around their abdomens, the higher their chance of reporting chronic musculoskeletal pain.

To weed out contributing factors, the researchers adjusted for many things, such as age, height, ethnicity, household income, education, alcohol frequency, smoking, physical activity, comorbid conditions, sleep duration, psychological problems and follow-up time.

While a specific link between abdominal fat and chronic pain may be new, the idea that fat could contribute to chronic pain by making people more sedentary and less likely to exercise has a long history.

However, as a patient who gained weight after developing chronic pain and being put on a number of medications that had weight gain listed as a side effect, I’m always extremely skeptical about which causes which. 

Especially because I gained and lost weight multiple times over the 11 years that I’ve been in pain, and have never noticed either one impacting my pain levels. 

In my experience, many doctors are quick to dismiss symptoms when they can blame a patient’s weight as the cause. Even when the excess weight was literally caused by medications they prescribed. 

Doctors use studies like these to blame pain patients for their problems, while absolving themselves of any responsibility to help. Patients are told their pain is their fault, and if they’d just lose weight, they’d feel better. 

Then, when losing weight proves predictably difficult, the doctor can throw up their hands at the whole situation and proclaim that the patient must not want to get better. In other words, doctors set an impossible standard for patients and then blame the patient when they fail to meet it. 

As new weight loss GLP-1 medications like Ozempic and related drugs become more popular, it will be interesting to see how they impact conversations about weight loss and chronic pain. If the medications are as good as they claim to be at helping people lose weight, we might finally get some large-scale research into how losing weight actually impacts pain levels. 

And if more patients are able to lose weight when their doctors tell them too, physicians may find that they have to do more than just tell their patients to “lose weight” when it comes to treating pain.

Cannabis Advocates Push Back on California Plan to Ban Hemp THC

By Crystal Lindell

The cannabis industry is pushing back on plans by California Gov. Gavin Newsom to impose emergency regulations that would effectively ban all food and beverage products containing Delta-8 tetrahydrocannabinol (THC) derived from hemp.

The proposed regulations would require that any products intended for human consumption have no detectable levels of Delta-8 THC or other intoxicating hemp cannabinoids; establish a minimum age to purchase hemp products at 21; and limit the number of servings of hemp products to five per package.

When hemp was legalized by Congress in 2018, the thinking was that hemp had such minimal amounts of THC that no one could possibly use it to get high. But cannabis companies soon found ways to tweak the chemical composition of hemp-derived THC and other cannabinoids (CBD) to make them more potent. Edibles containing delta-8 THC are now widely sold as candy, cookies, gummies and beverages – even in states where medical and recreational cannabis are still illegal.

“We will not sit on our hands as drug peddlers target our children with dangerous and unregulated hemp products containing THC at our retail stores,” Newsom said in a statement. “We’re taking action to close loopholes and increase enforcement to prevent children from accessing these dangerous hemp and cannabis products.”

But the advocacy group Cal NORML says Newsom’s regulations go too far and would make it impossible to sell any products containing hemp-derived CBD. It wants the rules modified to allow for non-intoxicating levels of THC. . 

“In practice, it’s impossible to eliminate detectable but non-intoxicating traces of THC from natural hemp extracts,” the group said. “THC is readily detectable at levels of 1 billionth of a gram, far below the threshold of human sensitivity.”

Cal NORML says the practical result of Newsom’s proposal would be to ban a host of hemp products that some people use to treat health conditions. It wants California to adopt Colorado’s definition of non-intoxicating hemp. That state allows hemp extracts with a CBD:THC ratio of at least 15:1 and no more than 1.75 milligrams of THC per dose. 

“There’s no danger that minors will try to get high on hemp products with less than 2 mg of THC, especially when other, much more potent marijuana products are readily available at bargain prices on the illegal market,” the group said.

“[Cal NORML] does not take issue with the regulations’ intent to block the sale of hemp products with intoxicating levels of THC in liquor stores, gas stations, smoke shops and convenience outlets, often with inadequate labeling and in a manner accessible to minors.”

As currently drafted, Cal NORML says the proposed regulations would violate the mandate of California’s medical marijuana law to provide “safe and affordable” access to cannabis for all patients in medical need.

Another advocacy group – One Hemp – is threatening a lawsuit against Newsom for exceeding his authority to enact emergency regulations without the approval of the state legislature.

“Newsom’s overreach is shameful,” said Jared Stanley, founding member of One Hemp.  “Other states have successfully banned Delta 8 products while also protecting natural hemp products through a simple solution that would safeguard ALL California’s children, not just some.”

“These rules signify that the Governor intends to turn his back on my daughter and millions in the disabled community,” says Stephanie Bohn, whose 10-year old daughter recently marked one year without seizures after she started taking natural hemp CBD.

“Governor Newsom, please acknowledge children like my daughter – the ones with intractable seizures and debilitating insomnia that conventional pharmaceuticals don't help. The only thing that offered rescue was full-spectrum CBD. This is more than a policy issue, this is a life-or-death issue.”  

One Hemp says parents of disabled children in California are “panic buying CBD products” before the proposed regulations take effect. 

The hemp rules await final approval from the California Office of Administrative Law. If they are approved, sellers of hemp products will be required to immediately impose purchase restrictions and remove items with detectable THC levels.

FDA Shutting Down Fentanyl Access Program for Cancer Patients

By Pat Anson

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

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

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

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

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

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

FDA TIRF-REMS UPDATE

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

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

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

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

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

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

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

Is the Hype About a New Non-Opioid Analgesic Justified?

By Carol Levy

In a previous column, I asked why pharmaceutical companies haven’t been able to “build a better mousetrap” by developing new and effective non-opioid medications for pain 

Every doctor I've seen about my chronic facial pain has only offered me opioids. As is true for many of us, I hate the way they make me feel. They also rarely help, outside of making me so cloudy-headed that I become less aware of the pain and have trouble thinking clearly.

That is the exact opposite of what the drug is supposed to do. It's supposed to make me feel better, and therefore better able to work, play, and do regular activities — which is exactly what the cloudiness stops me from doing. That's not a workable trade-off.

When I protest, “There must be something other than an opioid,” the reply from doctors is always the same: “There is nothing else.”

Now there may be. The FDA is giving priority review to a new drug application for suzetrigine, an experimental non-opioid analgesic developed by Vertex Pharmaceuticals. The drug has previously been granted “Fast Track” and “Breakthrough Therapy” designations by the agency for the treatment of moderate-to-severe acute pain. Final approval could come in January, which would make suzetrigine the first new class of medication for pain in over two decades.

The upside to suzetrigine is that it’s not an opioid. That would address the lie that we are responsible for the opioid crisis, and should be held captive by doctors who fear being raided by the DEA and don’t prescribe opioids anymore.

The downside is that suzetrigine is being considered as a treatment for acute pain and perhaps chronic neuropathy. My pain is neuropathic in nature -- trigeminal neuralgia and anaesthesia dolorosa (phantom pain) --- so I was at first exhilarated, and then deflated to see that suzetrigine is only being studied as a treatment for diabetic peripheral neuropathy. I had hoped this would be something for all of us.

I Google searched for other non-opioid analgesics, hoping there might be some new ones in the process of testing or even FDA fast-tracked. I couldn't find any.

As I researched further, I began to feel dejected. All drugs have downsides. That is expected. But I had hoped the FDA’s priority review meant the research was very positive about suzetrigine. Instead, I found there are many questions as to whether the drug is any better than what is already out there.

So why is the FDA fast-tracking it? Are they so eager to approve non-opioids that anything that might work will be considered? Maybe. The breakthrough therapy and fast-track designations may be geared more towards appeasing the FDA’s critics than anything else.

The headlines sounded so promising. “New Painkiller Could Bring Relief to Millions” and “A New Class of Medicine for Pain Relief On The Horizon.”

When I found out about this drug my heart leaped. Now I am not so sure. I hope it's not just another false flag. 

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. 

Brain Imaging Shows How Mindfulness Reduces Pain

By Pat Anson

Chronic pain patients have long been skeptical of mindfulness meditation, a form of cognitive behavioral therapy that is often touted as an alternative treatment for pain. Here are a few of the comments we’ve gotten about mindfulness over the years:

“Mindfulness is helpful. But it is only helpful when the pain is under control enough to implement it. If you are rocking back and forth from excruciating pain, any alternative therapies are useless.”

“Mindfulness may distract from pain while you are doing it. But it doesn't have any long-lasting effects.”

“Mindfulness is lazy hippie horseshit. It’s not medicine. It’s not science. It’s not therapy.”

But a new study published in Biological Psychiatry found some of the first physical evidence that mindfulness activates neural processes in the brain that help reduce pain levels. Researchers at the University of California San Diego School of Medicine used advanced fMRI brain imaging to compare the pain reducing effects of mindfulness with placebo treatments.

The study involved 115 healthy volunteers who were randomly assigned to four groups. One group participated in a guided mindfulness meditation, while the others received “sham” mindfulness that only consisted of deep breathing or a placebo cream that participants were told reduced pain. The fourth group listened to an audio book and served as a control.

The researchers then applied a painful but harmless heat stimulus (120°F) to the back of the leg and scanned the participants’ brains both before and after the interventions.

Compared to the other three groups, researchers found that mindfulness meditation produced significant reductions in pain intensity and pain unpleasantness ratings, while also reducing brain activity patterns associated with pain and negative emotions. Although the placebo cream and sham-mindfulness also lowered pain, mindfulness meditation was significantly more effective.

“The mind is extremely powerful, and we’re still working to understand how it can be harnessed for pain management,” said lead author Fadel Zeidan, PhD, a professor of anesthesiology at UC San Diego Sanford Institute for Empathy and Compassion. “By separating pain from the self and relinquishing evaluative judgment, mindfulness meditation is able to directly modify how we experience pain in a way that uses no drugs, costs nothing and can be practiced anywhere.”

Zeidan and his colleagues found that mindfulness reduced the synchronization between brain areas involved in introspection, self-awareness and emotional regulation. Those parts of the brain comprise the neural pain signal (NPS), a pattern of brain activity thought to be common to pain across different individuals and different types of pain.

In contrast, the placebo cream and sham-mindfulness did not show a significant change in the NPS when compared to controls. Instead, those interventions engaged entirely separate brain mechanisms with little overlap or synchronization.

“It has long been assumed that the placebo effect overlaps with brain mechanisms triggered by active treatments, but these results suggest that when it comes to pain, this may not be the case,” said Zeidan. “Instead, these two brain responses are completely distinct, which supports the use of mindfulness meditation as a direct intervention for chronic pain rather than as a way to engage the placebo effect.”

Researchers hope that by understanding changes in the brain associated with mindfulness, they can design more effective treatments to harness the power of mindfulness to reduce pain.

In a 2018 study of mindfulness that also induced pain through heat, Zeidan found that a part of the brain that processes thoughts, feelings and emotions – the posterior cingulate cortex -- was more active in people who reported higher pain levels. Participants with lower pain levels had less activity in that critical part of the brain.

“Millions of people are living with chronic pain every day, and there may be more these people can do to reduce their pain and improve their quality of life than we previously understood.” said Zeidan.

Deception Was Used to Get Patients to Participate in Opioid Study

By Pat Anson

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

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

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

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

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

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

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

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

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

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

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

‘Hypothetically Significant’

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Direct-to-Consumer Prescription Programs Seem Ripe for Misuse

By Crystal Lindell

Two large pharmaceutical companies have launched websites that help consumers get prescriptions to the medications that they make – and I’m honestly surprised that the entire setup is even legal.

Pfizer launched PfizerForAll in August, while Eli Lilly started LillyDirect back in January. Both websites connect patients with supposedly independent doctors, who can then write prescriptions – for Pfizer or Lilly medications, of course. Both companies will then help facilitate getting the prescription filled, even offering to connect patients with direct-to-home delivery. 

While direct-to-consumer prescriptions may seem like a win for patients – considering how overly complicated and expensive the U.S. healthcare system is – it also seems ripe for misuse. And when it comes to healthcare, that can have serious consequences, up to and including death.

Pfizer says its new website serves patients seeking treatment for migraines, COVID-19 or influenza, as well as adults seeking vaccines for preventable diseases, including COVID, flu, RSV and pneumococcal pneumonia. 

To be more specific, PfizerForAll facilitates patient access to Pfizer medications for migraine, COVID-19 or flu, as well as Pfizer vaccines. Maybe they should just call it AllForPfizer.

Meanwhile, Eli LIlly’s site is for patients seeking treatment for obesity, migraine and diabetes. Like Pfizer’s program, LillyDirect provides access only to “select Lilly medicines.” Maybe they should change the name to DirectToLilly. 

Both companies say their direct-to-consumer programs are designed to make things easier for patients who lack the time, knowledge and resources to manage their own health. 

“People often experience information overload and encounter roadblocks when making decisions for themselves or their family in our complex and often overwhelming U.S. healthcare system. This can be extremely time-consuming and lead to indecision or inaction – and as a result, poor health outcomes,” Aamir Malik, Executive Vice President and Chief U.S. Commercial Officer for Pfizer, said in a press release.

"A complex U.S. healthcare system adds to the burdens patients face when managing a chronic disease. With LillyDirect, our goal is to relieve some of those burdens by simplifying the patient experience to help improve outcomes," David Ricks, Lilly's chair and CEO, said when LillyDirect was launched

To make it easier for patients to buy Pfizer and Lilly products, both companies offer similar amenities. 

PfizerForAll boasts access to same-day doctor appointments; home delivery of prescriptions, over-the-counter drugs and tests; appointment scheduling for vaccines; and even help paying for Pfizer medicines. 

The LillyDirect site is similar. It offers "independent healthcare providers” and home delivery of Lilly medicines through “third-party pharmacy dispensing services." Lilly says its vendors make treatment decisions based on their own “independent medical judgment.”

So, yes, patients will get appointments with supposedly independent doctors. But something tells me the doctors getting booked with patients via Lilly’s website aren’t going to be writing any prescriptions for Pfizer medications. Or vice versa. 

I’m also very skeptical of the claim that doctors aren’t getting any money from the companies directly. Even if they are only getting referrals, that’s more than enough to heavily incentivize doctors to only prescribe medications that those companies make. Especially if the doctors are told that the patient they are seeing was referred to them by the pharmaceutical company itself.

Personally, when I see a doctor, I want them to write prescriptions based on what’s in my best interest – not what’s in the best interest of a pharmaceutical company. Perhaps it's naive and idealistic of me to still believe that doctors are writing prescriptions based solely on a patient’s need for that specific medicine.  

Perhaps healthcare in the United States is already so far beyond that thought process that these new websites aren’t too much of a leap. After all, pharmaceutical companies have long been working hard to influence doctors. So, maybe this is just the next logical step. 

Whenever I go to a makeup store like Ulta, I’m well aware that the seemingly helpful sales clerks are all trying to push me toward a specific lipstick brand. They may even get commissions from the lipstick company for making a sale. 

But, the thing is, what brand of lipstick I wear isn’t a life or death decision. I expect more from companies that make medications. Even if they don’t hold themselves to a higher standard, I expect more from the government regulators who allow this sort of thing. 

Yes, healthcare in the United States is horrific. I know that firsthand. I’m just not convinced that pharmaceutical companies have much interest in helping to fix that. 

CRPS: My Painful and Unwelcome House Guest

By Liliana Tricks

Complex Regional Pain Syndrome (CRPS) is like an unwelcome house guest that refuses to leave. It arrives uninvited, overstays its welcome, and disrupts your life completely.

CRPS took residence inside my body after my left foot was injured in 2017.  It feels as though someone is hacking at my leg with a meat cleaver, while a thousand insects bite and nibble at my flesh.

Living in Australia, I soon discovered that CRPS is largely unknown, and many specialists I encountered admitted they hadn’t even heard of it. This lack of understanding left me feeling vulnerable and isolated, as I had to rely on medical professionals who were often blind to my condition.

Clothes, once a source of joy and self-expression, now feel like a torment. I used to adore shopping, pampering myself with manicures, and indulging in all things feminine. But now, those same pleasures have become painful reminders of my limitations.

The clothing that once brought me comfort and confidence now itch, feel heavy, tight and suffocating. It's as if my skin is covered in prickles, shrapnel and itchy powder, making every movement a struggle.

Shoes, my former weakness, now sit in their boxes, ornaments of a life I once knew. My foot, a constant source of pain, swells and protests even the slightest pressure. There's no appeasing it, no soothing its fragile skin.

Simple tasks, like putting on pants, can derail my entire day. It's as if I've suddenly gained 100 pounds and all my clothing is too small. The uncertainty is maddening. Will my clothes be okay to wear today? Will my shoes be too tight? Will the socks dig into my foot, causing unbearable pain?

LILIANA TRICKS

I used to dream of exploring the world, hiking in the mountains of Nepal, immersing myself in new cultures, and starting a family. Now, my only wish is to endure the day without my body betraying me.

Humidity has become my arch-nemesis, a villain that steals my comfort. Cold weather is a cruel joke, rendering my body statue-like. When it warms, I feel like I am trapped in a heated sauna.

Growing up in neglect, surrounded by drug and alcohol abuse in my family, I vowed to avoid that path. But when CRPS moved in and consumed my life, I became dependent on medication. My mind is now clouded by a cocktail of medications that once delivered relief, but now only numbness.

I was prescribed apo-clonidine, alprazolam, gabapentin, Ativan, Valium, Lyrica, buprenorphine, tapentadol, codeine, apo-tramadol and Celebrex, just to name a few.

This nightmare concoction turned me into a docile Muppet, where I lost my sense of self. Labelled “non-compliant” due to my inability to attend doctor appointments and therapies, I felt isolated and alone. I barely survived those years, lost in a haze of medication.

Life resembled a puzzle, where the pieces seem ever-changing or lost. Friends, family and my social life dissolved. Being bedridden followed, as my body began failing me. That's when monstrous thoughts invaded, taunting me with all the places I'll never see: Scotland, England, Bali, Thailand. My dreams are now a constant reminder of my losses.

The relentless pain of Complex Regional Pain Syndrome ravaged my once vibrant spirit, leaving behind a hollow, sorrowful shell. I was simply existing. Sleep became a distant memory, replaced by restless nights filled with sweat, and hot and cold flashes. The changing of seasons felt like a cruel joke, as my world shrunk, chained with me to the confines of my bed.

CRPS drove me to apply for “voluntary assisted dying” or euthanasia. But I was deemed too young and too healthy.

Forced to live decades more in constant pain, I've come to realize that even those who suffered brutal deaths, like being hung, drawn and quartered, suffer for only a moment. Yet, in the 21st century, I'm expected to endure this agony because it doesn't bother anyone else. The pain is beyond comprehension, but others dictate what I should endure.

My mind yearns to do what my body cannot, leaving me stuck on a seesaw, half in the air, half on the floor, unable to move. Everything is fatiguing, seems out of place, and lacks familiarity.

Finding the strength to fight is challenging when understanding is scarce. I feel trapped in a world as unpredictable as a broken clock, caught in a time loop.

Ultimately, nothing remains unchanged. Each minute differs from the next. Each day brings its own uniqueness. The ability to perform an activity one day doesn't guarantee the same the following day.

At times, I may walk with slightly more ease, only to find moments later that I'm unable to walk at all. Suddenly, my body will feel heavy, fragile and brittle, as if my brain is no longer connected with the lifeless body it now drags. 

That’s when I often hear remarks like, "That's sudden." But it's not.

It's a challenge to learn to comfort oneself against the constant pain and flares. Otherwise, one might end up screaming incessantly for the rest of their life. Whether you express your pain loudly or keep it to yourself, the way you handle it doesn't determine its presence or absence. The intensity of someone's pain can’t be measured by screams.

There are moments when I do scream, hoping the pain will vanish. Other times, I attempt to “breathe it out.” There's no cure for CRPS, no instant relief, no definitive solution, not even a temporary fix, because nothing is certain to work consistently.

One must come to terms with life's new constraints. After eight years, I still battle every moment to accept my altered existence. This chronic nerve disease has overshadowed my life and keeps me in constant loops of various pains.

With a background in physical therapy, I have fought to maintain my strength despite the challenges. It hasn’t been easy; I've watched my body deteriorate, but I've also witnessed improvements through dedicated therapy. Every extra hour, day, or minute that I’m not confined is a testament to my resilience.

“If you don’t use it, you lose it,” became my guiding mantra.

I spent years blaming those who had a hand in my injury that resulted in CRPS. I didn't know how to let the anger go. I can’t change the past, but I could sit and stew in it, punishing myself further. For a while I did exactly that, but now I'm learning to accept it. The web of highs and lows.

This journey is mine, and my acceptance is what matters. Today, I search for peace in my life and hope for others when there is disappointment. I strive to push myself, for the moment I stop, I lose.

I remain steadfast, persevering in the struggle, and continuing to strive for joyful times. Because I still matter.

Liliana Tricks is 33 years old and lives in Western Australia.

Louisiana’s New Law Shows How Opioid Phobia Ushered in Abortion Restrictions

By Crystal Lindell

I’ve long said that pain medication is a “my body, my choice” issue – and a new Louisiana law really drives home the connection between opioids and abortion regulations. 

The state passed a law back in May that re-classifies mifepristone and misoprostol – two medications taken in tandem to induce abortion – as Schedule IV controlled substances, the same category as Xanax and Valium. 

Misoprostol is prescribed for a variety of situations, including reproductive health emergencies, as well as miscarriage treatment, labor induction, or intrauterine device (IUD) insertion. Because it is also used for chemically-induced abortions, the drug has long been a target of pro-life advocates in Louisiana, where abortion was criminalized in 2022.  

Under the new law, possession of either mifepristone or misoprostol without a prescription from a specially licensed doctor is a felony punishable by up to 5 years in prison.

It’s the biggest sign yet that the War on Drugs has officially collided with abortion rights in our post-Roe V. Wade world. Indeed, as states continue to restrict access to opioids and other medications, it becomes more and more obvious that pain patients and abortion rights advocates share a common fight. 

The state law goes into effect Oct. 1, but a report in the Louisiana Illuminator highlights how it’s already causing "confusion and angst" amongst healthcare professionals. 

In anticipation of the new law, some Louisiana hospitals are already removing mifepristone from their obstetric emergency care carts, where it would be used in the case of hemorrhage after delivery to stop bleeding and save a mother’s life. Removing it from the cart and locking it up is a standard practice at hospitals for controlled substances, but it means that mifepristone can’t be accessed immediately during emergencies. 

“Doctors and pharmacists are scrambling to come up with postpartum hemorrhage policies that will comply with the law while still providing proper medical care for women,” the Illuminator reports. 

Note how the idea of not complying with the law – which many doctors have personally disagreed with – doesn’t even seem to enter the realm of possibility. It’s the full manifestation of “just following orders” justification. 

One doctor theorized that the pending law also likely explains why pharmacists had been “pushing back” when she prescribed misoprostol for outpatient miscarriage management.

“They’ve been calling her to request clarification on why she prescribed the medication, and one pharmacy refused to fill the prescription,”  the Illuminator reported. “She had to send that patient to a different pharmacy. Her patients often travel hours to see her, and she regularly has to call in misoprostol to help them manage care at home.”

Pharmacies pushing back on doctor's prescriptions? That sounds familiar. In fact, many patients who take necessary medications like hydrocodone for pain or Adderall for ADHD have numerous stories to share about pharmacists trying to block their prescription from being filled.

And while it may not seem like it at first, all those points of friction in the process do lead to doctors refusing to prescribe controlled medications because they don’t want to deal with the hassle and risk of going to prison. It’s an outcome that I’m sure the Louisiana lawmakers who pushed the legislation through are hoping for with abortion-related medications. 

Making a Choice

It’s a grave mistake to think we can isolate things like pain medication restrictions from the rest of healthcare. Every new restriction that takes options away from doctors and patients paves the way for the next one that comes down the pike. 

Pro-choice advocates sometimes try to claim abortion medications shouldn’t be restricted because they are “life-saving.” However, many other controlled substances are also life-saving and we don’t see the pro-choice movement standing up for patients who need them. Those patients are also making a “choice” about their own bodies.

Untreated ADHD is proven to lower your life expectancy. Untreated and under-treated pain can cause a number of complications, from needless suffering and withdrawal to longer recovery times and even death when patients are forced to find pain relief on the unsafe black market.

Controlled substance laws make it much more difficult for patients who need medications labeled with that classification to get them – and people do die as a result. Just as people will likely die as a result of the new law in Louisiana. 

My concern is that the general public has been too quick to accept medication restrictions as necessary when they are promoted as solutions to things like the “opioid crisis.” I fear that people will start to believe that mifepristone and misoprostol are actually worthy of the classification of “dangerous controlled substance,” just as they believe medications like hydrocodone and Adderall are.

Unfortunately, if pain treatment is any indication, I don’t expect many doctors or hospital administrators to be willing to risk personal punishment for the health of their patients. I have personally seen doctors refuse opioids to dying patients because they “might get in trouble.”

I expect most medical professionals and hospitals will comply with the new Louisiana regulations without much tangible push back.

On the other hand, maybe there is a small place for hope here. Imagine a world where classifying more drugs as controlled substances helps medical professionals and the public understand why these classifications are problematic – legal frameworks that lack sound medical reasoning. Unfortunately, I don’t see that happening any time soon. 

In the meantime, pro-choice advocates could learn a lot from those of us who have been on the front lines of the drug war for decades. If we want to have any hope of victory, we all need to join together to fight all restrictions on bodily autonomy – whether it’s related to reproductive health, pain management, or any other health condition. 

We must join forces now. The longer we wait, the more emboldened governments will become in making choices for us.

FDA Clears New Prescription-Only TENS Device

By Pat Anson

Transcutaneous electrical nerve stimulation – more commonly known as TENS – uses mild electric currents to temporarily relieve pain in sore muscles and tissues. Some TENS units are elaborate wearable devices that cost hundreds of dollars, while others are simple gadgets that can be purchased online or over-the-counter for about $30.

Due to lingering questions about their effectiveness, many health insurers don’t cover TENS devices, while others make patients jump through hoops to get reimbursed for them.

Medical device maker Zynex Medical is hoping to bridge the gap in insurance coverage with a new TENS device called TensWave, which is only available by prescription. The company says the FDA has “cleared” TensWave for marketing, allowing sales to begin immediately.

"The introduction of TensWave aligns perfectly with our commitment to providing comprehensive pain management solutions," Thomas Sandgaard, CEO of Zynex, said in a press release.

"We recognized a gap in the market for a high-quality TENS device that meets the specific criteria for insurance reimbursement, and TensWave is our answer to that demand. It complements our flagship multi-modality device, the NexWave, where Interferential current is the main modality and driver of obtaining prescriptions. This device broadens our product portfolio and enhances our support to patients."

ZYNEX IMAGE

Unlike NexWave, which has three different electrical stimulation modalities, TensWave only uses TENS technology, which Zynex believes will make it easier to get insurance coverage. The company currently has no estimate of TensWave’s cost if a patient has to buy it out-of-pocket.   

In its press release, Zynex said TensWave “has been clinically proven to reduce chronic and acute pain,” which is a bit of an exaggeration, because the device did not go through the FDA’s lengthy review and approval process. However, because TensWave has “substantial equivalence” to other TENS units already on the market, it was cleared for sale without ever undergoing a clinical trial to prove its safety and efficacy. This is a common practice allowed by the FDA when new medical devices are introduced.

The World Health Organization takes a dim view of TENS, saying the evidence of its effectiveness in relieving chronic lower back pain is “very low” due to a limited number of clinical trials. In some trials, TENS worked no better than a placebo.

The UK’s National Health Service (NHS) has a similar view of TENS, saying there is not enough good-quality evidence to recommend its use as a reliable method of pain relief.

“Healthcare professionals have reported that it seems to help some people, although how well it works depends on the individual and the condition being treated,” the NHS states. “TENS is not a cure for pain and often only provides short-term relief while the TENS machine is being used.”

Got a Surprise Medical Bill? Complaining About It Usually Pays Off

By Erin Duffy

What do you do when you disagree with or can’t afford a medical bill?

Many Americans struggle to pay medical bills, avoid care because of cost worries or forgo other needs due to health care cost burdens.

It can be hard to understand what you’re being charged for on a medical bill. I’m a health policy and economics researcher who studies insurance and out-of-pocket health care expenses, and even I sit at my kitchen table trying to wrap my head around bills and explanations of benefits.

In my newly published research, I surveyed a nationally representative sample of 1,135 American adults – a subset of participants from the University of Southern California’s Understanding America Study – to find out how they handle troubling medical bills. I learned that advocating for yourself can pay off when it comes to medical bills, and you may be missing out on financial relief when you don’t pick up the phone.

Squeaky Wheel Gets the Grease

My team and I found that 1 in 5 patients had received a health care bill in the prior year that they disagreed with or couldn’t afford. Nearly 35% of the bills came from doctor’s offices, nearly 20% from emergency rooms or urgent care and over 15% from hospitals. Other sources of bills included labs, imaging centers and dental offices.

A little over 61% of respondents contacted the billing office about a troubling bill, but 2 in 5 did not. Why not? About 86% of patients said they did not think it would make a difference.

But reaching out got results. Nearly 76% of patients who reached out got financial relief for an unaffordable bill. Nearly 74% who spoke up about a potential billing mistake received bill corrections. For those who negotiated their bills, nearly 62% saw a price drop.

Additionally, 18% of patients who reached out got a better understanding of their bill, 16% set up payment plans and a little over 7% got the bill canceled altogether. Nearly 22% said their issue was unresolved, and 24% reported no change.

The majority of people who reached out about their medical bills reported that it took less than one hour to handle their issue.

Grumpy Extroverts Get Results

We found that people with a more extroverted and less agreeable personality – based on the Big Five Personality Test – were more likely to reach out about a medical bill. People without a college degree, with lower financial literacy or with no health insurance were less likely to reach out to a billing office.

Differences in who does and doesn’t call about a medical bill may be exacerbating inequalities in how much people end up paying for health care and who has medical debt.

Many Americans are in health plans with high out-of-pocket cost sharing, including high-deductible plans. This so-called consumer-directed health care paradigm is intended to motivate consumers to be more cost-conscious when seeking care and navigating their bills. But by design, it puts the burden on patients to deal with billing issues.

Another recent study my team and I conducted found that 87% of U.S. hospitals offer their own payment plans, but only 22% of these put plan details on their websites. You have to call for more information.

In another recent study, my team called hospitals as “secret shoppers” planning an elective knee surgery. We sought information critical to assessing affordability: financial assistance, payment plans and payment timing options. While the information was often available, it was hard to access. We couldn’t reach a representative with information at about 18% of hospitals, even after calling on three different days. We were typically directed to three different offices to get all the information we wanted.

Policymakers have made strides in price transparency in recent years. For example, hospitals are required to post prices for their products and services. Practices and policies that further reduce the administrative burden of accessing aid and navigating troubling bills.

Pick Up the Phone

Patients who make the call are benefiting when it comes to medical bills.

A colleague who knew I was working on this study asked me for advice about a $425 bill her household had received for a lab test at an urgent care center. The bill seemed inflated and unfair, forcing an unexpected stretch to her budget.

I told her it was worth a call to the billing office to express her feelings about the bill and see whether any adjustments could be made to the amount owed or the timing of payment.

It was worth the call. The billing office representative offered three options on the spot:

a.) a payment plan, b.) a prompt payment of $126 paid immediately over the phone to settle the account, or c.) financial assistance if eligible based on income.

My colleague chose option b and paid less than one-third of the original bill amount.

The next time you get a medical bill that troubles you, pick up the phone or ask a disagreeable extrovert to make the call for you.

Erin L. Duffy, PhD, is a research scientist and the Director of Research Training at the USC Schaeffer Center for Health Policy and Economics. Her research explores cost-drivers, market failures, and patients’ financial liability in the U.S. healthcare system.

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

DEA Delays Decision on Reclassifying Marijuana Until After the Election

By Crystal Lindell

The Drug Enforcement Administration has likely eliminated any possibility of marijuana being rescheduled until after a new president is sworn into office next year. The agency will hold a public hearing on the matter on December 2nd —  nearly a month after the presidential election —  according to a notice published yesterday in the Federal Register. 

The hearing will help determine if marijuana should be re-classified under Schedule III of the Controlled Substances Act (CSA) from its current status as an illegal Schedule I substance. 

Moving marijuana to schedule III would place it in a category of drugs that are considered to have an accepted medical use. Rescheduling would also indicate that cannabis has less potential for abuse than Schedule I and II substances, with only moderate to low risk of physical or psychological dependence. 

But the DEA has also made it clear that rescheduling does not equal legalization, noting that “the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA.” 

To make a cannabis-based medicine legal under Schedule III, the Food and Drug Administration would first have to approve it for a specific medical condition, which would likely require a lengthy clinical trial process that could take years to complete.

The National Organization for the Reform of Marijuana Laws (NORML), an advocacy organization that has long fought for cannabis to be legalized, says it’s not surprised that the DEA wants to have public hearings. 

“Hearings are an integral part of the rescheduling process. To think that the DEA, which historically has opposed any changes to cannabis’ prohibitive status, would sign off on the most significant proposed change in federal marijuana policy in over fifty years absent such hearings was always wishful thinking,” said NORML Deputy Director Paul Armentano.

“That said, the scientific evidence in favor of removing cannabis from Schedule I remains overwhelming. Cannabis clearly has legitimate therapeutic value and it possesses a superior safety profile compared to other Schedule I or Schedule II controlled substances.”

The Biden Administration initiated the regulatory process to review the scheduling of cannabis in late 2022, a review that has dragged on for nearly two years. The Department of Health and Human Services (HHS) recommended marijuana be moved to Schedule III in August 2023.

But the Justice Department and DEA Administrator Anne Milgram – who has the final say on rescheduling – have yet to approve the HHS recommendation.  The DEA published the proposed change in cannabis’ classification in May in the Federal Register. That notice drew over 43,000 responses during a 60-day public comment period, with numerous requests for a public hearing.

Seeing the process take so long is frustrating. With 38 states and the District of Columbia allowing medical cannabis, it’s clear that marijuana has a legitimate medical use – a fact confirmed by the HHS recommendation to reschedule. So why are the DOJ and DEA dragging their feet?  

Holding the public hearing after the presidential election also risks that it won’t be done at all, depending on who wins and what their policy preference is on the matter. 

Although Democratic nominee Kamala Harris is likely to continue President Joe Biden’s push to have marijuana reclassified, we can’t be sure what she would do. Republican nominee Donald Trump has also indicated in recent days that he favors “decriminalizing” marijuana, but we also don’t know with certainty what he would do. 

With so many states having already legalized the medical and recreational use of marijuana, it’s become increasingly clear that there are no compelling health-related reasons to continue classifying cannabis as a Schedule I controlled substance. And the longer the DEA delays changing marijuana’s status, the more it should make all of us question how much health concern there really is behind the Controlled Substances Act.