DEA Plans More Cuts in Opioid Supply, While Raising ADHD Stimulant Production

By Pat Anson

The U.S. Drug Enforcement Administration is planning more cuts in the supply of prescription opioids in 2025, while raising production of amphetamine and other stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

If the DEA’s plans are finalized after a public comment period, it would be the ninth consecutive year the opioid supply has been reduced.

Under the Controlled Substances Act, the DEA has broad legal authority to set annual aggregate production quotas (APQs) for drug makers – in effect telling them how much Schedule I and II chemicals and medications they can produce. DEA sets the quotas after consulting with the Food and Drug Administration (FDA) and other federal agencies, as well as individual states about the projected need for controlled substances.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2025 will decline on average 6.6 percent from calendar year 2024 levels. These declines are expected to occur across a variety of schedule II opioids. These declines are expected to occur across a variety of schedule II opioids,” the DEA said in a notice recently published in the Federal Register.

There will not be 6.6% cuts across the board for every opioid. Unlike previous years, the agency is proposing only slight reductions in the supply of fentanyl, oxycodone, hydrocodone and hydromorphone, while keeping quotas unchanged for morphine and codeine.

Most of the cuts are very minor – less than a tenth of one percent -- when the proposed APQ’s for 2025 are compared to the ones adopted in 2024.

DEA Opioid Production Quotas for 2025

• Fentanyl: 0.0025% decrease

• Oxycodone:  0.137% decrease

• Hydrocodone: 0.081% decrease

• Hydromorphone: 0.015% decrease

• Morphine: Unchanged

• Codeine: Unchanged

The DEA notice does not address the discrepancy between the FDA’s estimate of a 6.6% decline in medical need for opioids with the quotas it is proposing. The agency says it considered a “potential increase in demand for certain opioids” due to more elective surgeries being performed in 2025. Many of those surgeries were postponed during the COVID-19 pandemic.

The FDA predicted a 3.5% increase in domestic medical use of Schedule II stimulants in 2025. Demand for stimulants to treat ADHD has grown in recent years, but the drugs are also increasingly used to treat brain fog and fatigue caused by Long Covid. The FDA told DEA it was concerned about ongoing shortages of amphetamine, lisdexamfetamine, and methylphenidate, which are used to make stimulants such as Adderall.    

The DEA wants to raise production quotas for amphetamine (+5.9%) and lisdexamfetamine (+23.5%), while leaving the 2025 quota for methylphenidate the same as it was in 2024. The agency said inventories of amphetamine and methylphenidate-based products had increased, while shortages of lisdexamfetamin continue.

“DEA believes that manufacturers will be able to meet the increase in domestic medical need for these three schedule II stimulants with the APQs proposed in this notice,” the agency said.

The Myth of Opioid Diversion

The DEA has been cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by over 68% and hydrocodone by nearly 73% since 2015. Many of those cuts are due to pressure from Congress, as well as a common belief that prescription opioids are often diverted or sold to people they are not intended for.

That belief is largely a myth.

As required by Congress, DEA estimated the diversion rate of schedule II opioids in 2025, and once again came to the conclusion that diversion is rare – less than half of one percent for oxycodone and hydrocodone. Much of the diversion is a result of theft and losses in the supply chain, before opioids even reach patients.

Estimated 2025 Diversion Rates

• Oxycodone: 0.493%

• Hydrocodone: 0.379%

• Fentanyl:  0.013%

• Hydromorphone: 0.06%

The DEA’s diversion rates are partially based on “red flag” data from prescription drug monitoring programs (PDMP). Potential red flags include patients who see three or more prescribers in a 90-day period; patients who receive a daily opioid dose in excess of 240 morphine milligram equivalents (MME); and patients who pay in cash for a controlled substance.

DEA requested PDMP data from all 50 states, but only 29 states responded to the request by sharing summaries of their red flag data.

“While PDMP data is useful in estimating diversion, it is not conclusive. Further investigation would be required before concluding that any of the subject prescriptions were actually diverted. DEA continues to evaluate its methodologies in estimating diversion in an effort to set quotas more efficiently. State participation is crucial to accurate data analysis, and DEA anticipates working closely with states, as well as other federal and state entities, in future quota determinations,” the agency said.

Public Comments

The DEA quietly published its notice about 2025 production quotas in the Federal Register on September 25, with no fanfare or press release.

Usually the agency receives thousands of comments from the public about its production quotas, but so far there have been only a handful of comments posted. Many are from patients still bitter about the decade of cuts the DEA has imposed on the opioid supply, which have contributed to record shortages of prescription drugs.

“The actions that are being taken by Congress, by the DEA, state legislatures, and state medical boards, have caused THOUSANDS of these patients to lose access to their medications, have resulted in the improper prosecution of pain doctors, resulting in a severe nationwide shortage of pain specialists, and nationwide shortages of medications,” wrote David Smith.  

“The CDC, FDA, and DEA have severely underestimated the needs of chronic pain patients and misjudged the consequences of these cuts. While opioid misuse is a serious issue, penalizing legitimate pain patients is not the solution,” said Gina Harrison.

“Please I'm begging you not to cut opioids meds this year,” said Melissa Guthrie. “I'm on palliative care and there were a couple months last year I didn't get my meds due to shortages. You know it's not the pain meds causing harm. It’s the illicit fentanyl and street drugs killing people.”

You still have time to make your feelings known, as long as you do it by October 25, when the public comment period ends. To make a comment, click here.

Cancer Patients Abandoned When Fentanyl Painkillers Discontinued

By Pat Anson

Patients suffering from severe cancer pain are scrambling to find alternatives after a drug maker discontinued production of potent fentanyl analgesics.

Cephalon, which is owned by Teva Pharmaceuticals, notified the FDA in August that it was stopping production of Transmucosal Immediate-Release Fentanyl Medicines, known as TIRF medications. The FDA then told patients and prescribers that all TIRF meds would be discontinued on September 30.  

“The moment I heard TIRF medicine was being discontinued, I was nearly brought to tears because I fear going back to the way things were before.  I have until the supply runs out and that's it,” said Anthony, a 46-year-old Georgia man who has severe headaches from an inoperable brain tumor. He asked that we not use his last name. 

Anthony has been taking TIRF meds since 2016. He also had a pain pump surgically implanted to deliver opioids around-the-clock, but still needed TIRF for occasional breakthrough pain.

“To transition back to traditional opiates will be a major step back treating my breakthrough pain,” Anthony explained. “Before TIRF medications, I struggled, and my quality of life followed suit.  I spent more time laying horizontal in my bed. It's been a long battle. I'm lucky to still be here.”

TIRF meds are effective because they are absorbed quickly through the mouth and provide pain relief within minutes. The two meds discontinued by Teva are Actiq, a fentanyl lozenge, and Fentora, a fentanyl buccal tablet that dissolves in the mouth.

“Because both of these meds and possibly other forms of TIRF medications bypass the gastrointestinal tract, they are overwhelmingly beneficial in my breakthrough pain,” says Anthony, who is regularly drug tested to make sure he isn’t abusing TIRF.

“I do not get high or feel euphoria.  If I abused these meds that might be an issue, but I take as prescribed.  Plus, if I took more than intended, I would run out of meds before my next refill leaving me without.  Not to mention, I don't want to stop breathing.”   

‘I Think They’re Good Drugs’

Because TIRF medication is made with fentanyl, a synthetic opioid 100 times more potent than morphine, it is poorly understood by the public and often demonized by anti-opioid activists.

Illicit fentanyl is involved in about 70% of fatal overdoses, but prescription fentanyl is rarely diverted and has long played an essential role in treating severe pain. Less than one-tenth of one percent of prescription fentanyl – 0.088% -- is diverted, according to DEA estimates.

“I think breakthrough pain is a horrible thing, and I think these patients really benefit from these breakthrough pain medications,” said Tom Jenkins, PhD, Chief Scientific Officer and Co-Founder of Elysium Therapeutics, which is developing a new class of opioids with less risk of abuse.

“These transmucosal fentanyl drugs are really complementary to the profile of the breakthrough pain and really help patients manage it quite effectively. I think they're good drugs. I don't think they're widely prescribed, so I think the diversion of them is not as significant of a problem.”

Despite that, an op/ed being published in U.S. newspapers refers to TIRF meds as “candy” and “lollipops” – implying they are widely abused and marketed to children, not cancer patients.

“The withdrawal of these potent, short-acting fentanyl products is good news, but they never should have been approved in the first place,” wrote Dr. Adriane Fugh-Berman and Judy Butler, who are affiliated with PharmedOut and Physicians for Responsible Opioid Prescribing (PROP).

“Classified as transmucosal immediate-release fentanyl or TIRF products, these delivery methods are highly potent and highly addictive. The faster an addictive substance enters the bloodstream, the more abuse potential it has. TIRFs acted almost as fast as opioids used intravenously, and addicted many people.”

Fugh-Berman and several other PROP members have collectively been paid several million dollars by plaintiff law firms to be consultants or expert witnesses in opioid litigation, a detail not mentioned in the op/ed or by the news organizations that published it.

Adverse Events

It’s true that TIRF medications have been abused, but many of those cases involved Subsys, an oral fentanyl spray that was illegally marketed by Insys Therapeutics. Insys filed for bankruptcy in 2019, and the company’s founder and several top executives were later convicted of racketeering and bribing doctors.

According to the FDA, adverse events involving TIRF peaked in 2018, with nearly 22,000 reported cases. Since then, they’ve fallen by about 80%.

The decline in adverse events coincided with a steep drop in the number of cancer patients enrolled in the FDA’s Risk Evaluation and Mitigation Strategy (REMS) Program, which facilitated the safer prescribing of TIRF. Over 4,700 patients were enrolled in the TIRF program in 2017. Today there are fewer than 150.

Anthony is one of them.

“The small number of people on the meds are a result of the FDA strengthening the REMS requirements, making it a huge headache for doctors to not only prescribe TIRF meds, but also to keep patients on them, making so much extra work for the doctors,” Anthony told PNN. “Too much red tape involved, so doctors avoid like the plague.”

Another factor is cost. A supply of Actiq or Fentora that might last a few days or weeks for a cancer patient in severe pain will cost thousands of dollars. The drugs are often not covered by insurance.

‘It’s Opioid Phobia’

Why did Teva stop making TIRF medication? The company has not made any public statements about the discontinuation of Actiq and Fentora, and did not reply to PNN requests for comment.

The most likely explanation is that Teva’s bottom line was suffering, due in part to the costs of opioid litigation. In 2008, its Cephalon subsidiary paid a $425 million fine for the off-label marketing of Actiq and two other drugs. Then in 2022, Teva agreed to pay $4.25 billion to settle thousands of opioid liability lawsuits.

Last year, as part of a strategic restructuring, Teva discontinued production of generic oxycodone to focus on more profitable branded drugs.

“It's opioid phobia. I think these companies were spooked by the lawsuits. Maybe some of them did misbehave a little bit and deserved it,” said Elysium’s Jenkins. “I feel for the patients that were using these things appropriately, were getting relief, that are no longer able to access the drug.

“I can only imagine corporate lawyers were just saying, ‘Hey, this isn't worth it. Let's get out of this.’ And also the REMS program. I mean, the FDA is deliberately making it difficult for physicians to prescribe this drug, right?”

Caught in the middle of opioid litigation and a profit-driven healthcare system are cancer patients like Anthony.

“I do not feel the few remaining patients should be made to suffer by discontinuing TIRF medications.  I'm guessing they are doing this because it's no longer as profitable as it once was,” he said. “Why can't small batches be done to maintain the quality of life of the remaining TIRF patients?”

The FDA has shown no interest in keeping the REMS program alive by finding a new TIRF manufacturer. New applications from patients and prescribers are no longer being accepted. And calls to the program’s hotline go unanswered.

“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,” the agency said in a brief online statement.

Unsecured Opioid Prescriptions and Pet Meds Cause Child Poisonings

By Crystal Lindell

A new study highlights the need for patients and pet owners to make sure their opioid medication is kept secure and away from children. 

The study, published in The Journal of Pediatrics, looked at how young children are often exposed to prescription opioids.  The authors analyzed 230 pediatric opioid poisoning cases that were reported to the New Jersey poison control center over a 5-year period. Most of the exposures were unintentional and involved children under the age of two.

Researchers found that the opioids consumed by children most often belonged to parents (40%), grandparents (17.4%), friends and other family members (7.8%) or were intended for pets (4.3%).

Five incidents involved opioid medication that had been mixed with a food or treat intended for a pet. But when the pet didn’t take it or spit it out, a child found it. 

Dr. Diane Calello, a pediatric emergency physician and one of the study's authors, said it's common for a pet owner to mix medication with food to make it more palatable to their pet.  

“Anybody who has ever tried to give medications to a dog or a cat that doesn’t want to take it knows you put it in peanut butter or cheese,” Calello told WHYY News. “If you give a pet that medication and they walk six, eight feet away and then they spit it out on the ground, there’s that little morsel that happens to contain medicine in it and children can obtain that and put that in their mouth as well.”

As for the medications belonging to grandparents, Calello and her colleagues noted that older patients may not get much counseling on the proper storage of prescription drugs because healthcare providers assume they have no children living with them. 

Most of the child poisonings involved pharmaceutical opioids (86%), occurred in the child’s home (91%), and resulted in the child being admitted to a healthcare facility (84%).

Nearly 9% of the cases involved medication wrappers that were already opened, divided pills and buccal films that were improperly stored, and exposure to opioid residue left on tissue paper, cotton balls, cellophane and analgesic patches.

In some cases children came across used fentanyl patches, illicit drug paraphernalia, liquid opioids or discarded medication left in trash cans and handbags, or left on countertops. 

“People think when they’re handling intact medication in a prescription package, ‘That is something I need to keep safe,’” Calello said. “But you don’t have that same checkpoint in our brain for things that we throw away.”

The researchers recommend that the overdose reversing drug naloxone be prescribed to everyone getting opioids, whether they’re intended for a human or pet. Naloxone can be safely given to children after exposure.

Requiring naloxone prescriptions for patients getting opioids is controversial among pain patients, especially if they have to pay for it themselves out of pocket. 

However, studies like this show why anyone who takes opioids should consider carrying naloxone with them, especially if they are visiting a home with children.

Guideline: Pediatricians Can Prescribe Opioids to Children as Needed

By Pat Anson

Fears about children becoming addicted and overdosing on opioid medication have led to the undertreatment of acute pain in pediatric patients, according to a new clinical guideline by the American Academy of Pediatrics (AAP).

The AAP guideline – the organization’s first to address opioid prescribing to children and adolescents -- urges pediatricians to start with non-opioid medication when treating mild to moderate acute pain. Opioids can be prescribed if a child is in severe pain or doesn’t respond to non-opioid treatment.

“There’s been a big pendulum swing in the practice of medicine over the last two decades—first with opioid-overprescribing, then with a huge cutback in opioid prescribing, likely leaving some children’s pain undertreated,” said lead author Scott Hadland, MD, Chief of Adolescent Medicine at Massachusetts General Hospital and an Associate Professor of Pediatrics at Harvard Medical School

“We want pediatricians to prescribe opioids when they’re needed because untreated pain can lead to distress and psychological harm. At the same time, physicians need to take steps that reduce the long-term risk for addiction.”

The guideline recommends that immediate release opioids be used, starting with a low dose and an initial supply of five days or less. Opioids can be prescribed for longer periods if a child is recovering from trauma or surgery and the pain is expected to last longer than 5 days. Every prescription for opioids should also include a prescription for naloxone, an overdose reversal drug.

The AAP warns that codeine or tramadol should not be prescribed to patients younger than 12 years; adolescents 12 to 18 years of age who have obesity, sleep apnea, or severe lung disease; or when treating surgical pain after a tonsillectomy or adenoidectomy.

“For a patient with mild to moderate pain, doctors should always start nonopioid medications and treatment,” said guideline co-author Rita Agarwal, MD, a Pediatric Anesthesiologist and Professor at Stanford Medicine. “Opioids do remain an important tool for acute pain relief.  But there are times when acetaminophen and ibuprofen may be equally effective with fewer side effects, such as in procedures such as tonsillectomy, wisdom teeth removal, and fractures.”

The AAP’s guideline is based on a review of 11 clinical studies involving pediatric outpatients being treated for acute pain. Hundreds of other studies were excluded from the analysis because they involved adults or hospitalized patients.

The use of opioids by children and adolescents has been a contentious issue for many years. Opioids were once commonly prescribed after wisdom teeth removal, a practice that is now discouraged.

The AAP’s guideline review committee found that most children prescribed opioids do not become addicted or have an overdose. The risk of a child developing opioid use disorder or experiencing an overdose one year after a prescription ranged from 0.3% to 5.8%.

The World Health Organization (WHO) released a guideline in 2021 recommending that opioids only be given to children who are dying or seriously ill and not expected to recover. The WHO guideline found that “evidence of the effectiveness and safety of opioids is completely lacking in children.”  

Sickle Cell Patients Have Even Fewer Choices for Pain Relief

By Crystal Lindell

Pfizer is voluntarily taking its sickle cell disease medication Oxbryta (voxelotor) off the market, amid concerns that it could be causing deaths and other complications. Doctors are being told to stop prescribing Oxybryta and to start sickle cell patients on other medications. 

Pfizer said its decision was based on clinical data showing the overall benefits of Oxbryta no longer outweighs the risks. In postmarketing studies, patients taking Oxbryta had higher rates of a vaso-occlusive crisis, a condition that causes severe pain when mis-shaped red blood cells block the flow of blood to tissues and organs. Patients taking the medication also had higher death rates. 

The company said it was also discontinuing all clinical trials of Oxbryta and expanded access programs worldwide. Oxbryta has been on the market since 2019. The medication works by preventing red blood cells from becoming C-shaped and breaking down too quickly.

Pfizer’s announcement delivers another setback to sickle cell patients, who already lack treatment options and face discrimination in the healthcare system. There aren’t many treatments for sickle cell disease (SCD), a lifelong inherited blood disorder that can cause complications starting in early childhood and lead to shortened life expectancy.

The lack of treatments is due in part to the fact that SCD is relatively rare in wealthier countries. It primarily impacts those whose ancestors are from sub-Saharan Africa, an under-served patient population. About 100,000 Americans have SCD, a number so low it discourages drug makers from developing medications to treat it. Over 8 million people worldwide have SCD.

Many sickle cell patients have also borne the brunt of opioid phobia in the United States. They often end up having to go to the ER during pain flares, where many are treated as drug seekers. 

‘This Is a Step Backward’

The National Alliance of Sickle Cell Centers released a statement saying the Pfizer recall was disappointing. But they were glad that Pfizer was re-evaluating Oxbryta to see which SCD patients may still benefit from it..

"At this time, the risks are too great but there may be an opportunity in the future to better understand how to optimize this medication (and all) medications in sickle cell disease,” the organization said. 

It urged sickle cell patients currently taking Oxbryta to make an appointment with their doctor and emphasized that patients should not stop taking the drug abruptly. Instead, they should work out a weaning plan with their care team. 

“Don’t lose faith,” they said. “This is a step backward but we will stay on the path to better outcomes for everyone.”

The organization added that these types of issues highlight the importance of long-term follow-up with a sickle cell center and of clinical registries like GRNDaD, an international registry developed to track the effectiveness of SCD treatments.

“We encourage everyone to see a sickle cell specialist annually to review what is and what is not working for them,” the organization said. “We all know that sickle cell disease is highly variable, many people are different and respond differently to medications. We need to better understand these differences to identify which medication will work best for which people."

An article in MedScape explained that Pfizer’s decision to recall Oxbryta (voxelotor) came amid increased scrutiny of the drug by the European Medicines Agency (EMA). 

EMA began a review of voxelotor in July after data from a clinical trial showed that a higher number of deaths occurred with the drug than with placebo. Another trial showed a higher  number of deaths than expected. 

Pfizer’s Aida Habtezion, Pfizer’s Chief Medical Officer, said the recall was in the best interest of patients. 

“Our primary concern is for patients who suffer from SCD, which remains a very serious and difficult-to-treat disease with limited treatment options,” Habtezion said. “We advise patients to contact their physicians to discuss alternative treatment while we continue to investigate the findings from our review of the data.”

Patients, physicians, pharmacists, or other healthcare professionals with questions about Oxbryta should contact Pfizer at 1-800-438-1985.

Hurricane Helene Highlights Need for Emergency Prescription Access

By Crystal Lindell

Following the news for Hurricane Helene this week, I’ve been worried about everyone in its path. But it’s the people who rely on prescription pain medication that I am most worried about. 

When natural disasters strike, patients who rely on opioids and other controlled substances can be left to face withdrawal or the black market to fill the gaps until doctors and pharmacies are fully functioning again.

While some states have laws in place to allow people to get early refills of their prescriptions when there’s an impending natural disaster, those laws can specifically exclude controlled substances like hydrocodone and Adderall. 

According to a 2022 article by Healthcare Ready, the laws vary widely state-by-state and are poorly organized. Only 12 states have laws or regulations that allow for emergency prescriptions during a specified public health emergency. About half the states allow for short-term refills of medication during unspecified emergencies. Fifteen states and the District of Columbia don’t have any regulations allowing for emergency prescriptions.

The two states facing the worst from Hurricane Helene, Florida and Georgia, both have laws allowing for emergency prescription refills – but only one allows for refills of opioids. 

Georgia specifically excludes Schedule 2 controlled substances such as codeine, hydrocodone, morphine and amphetamines, according to Atlanta News First. 

Florida’s law is much more expansive. You can obtain a 30-day refill of any prescription medication, as long as your county meets one of the state’s disaster qualifications. 

My guess is that Florida is more lenient due to the state’s reputation as a retirement destination. Older retired people are more likely to need pain medication and more likely to vote. 

It’s understandable that states more commonly hit by hurricanes would have laws in place to address this issue, but every state should allow for emergency prescription refills. Natural disasters like earthquakes, tornadoes and wildfires can happen anywhere. 

Ideally, this would be something best addressed at the federal level, so that patients who have to evacuate their state during emergencies would know they can get refills no matter where they go. Pharmacists would also need to be aware of how to apply the regulations. 

The Food and Drug Administration recommends that patients have at least a week's supply of  medication in case of emergencies – something that’s impossible for many pain patients. You know things are not functioning correctly when a federal agency is giving medical advice that patients are literally unable to follow. 

The last thing anyone facing the threat of losing their home or even their lives should have to worry about is running out of hydrocodone. Even a small daily dose can cause withdrawal if stopped abruptly.

Medication withdrawal in normal conditions can feel like hell. I can’t imagine what it would be like if you also had to deal with the aftermath of a hurricane or wildfire. It could take days or weeks before power is restored, pharmacies to reopen, and supply chains to start functioning again.

Nobody should have to endure that, and with sensible laws in place across the country, nobody would have to. 

Are U.S. Overdose Deaths Really Declining?

By Pat Anson

Preliminary data from the CDC suggest that U.S. overdose deaths have declined significantly, falling by 10% in the last year alone. If confirmed, the double-digit drop would mean there were 11,247 fewer drug deaths in the 12-month period ending in April 2024.

The decline, first reported by NPR, was hailed by addiction and public health experts as a hopeful sign that progress is finally being made in reducing the number of drug deaths, which have doubled in the past decade to over 100,000 a year.

“This is exciting," said Dr. Nora Volkow, director of the National Institute on Drug Abuse. "This looks real. This looks very, very real."

Good news, if it’s true. But caution is warranted about how “real” the decline is, because preliminary death data often changes as more information comes in.

Overdose data is fragmented in both quality and quantity, as it comes from 50 different sources. The data is collected by each state and then submitted to the CDC to decipher for its monthly Provisional Drug Overdose Death Count.

Some states still do not use toxicology tests to confirm whether a death is drug-related – leaving it up to medical examiners and coroners to decide which drugs, if any, may have played a role in someone dying. Some elected coroners, particularly in rural counties, have no medical training or expertise in drug death investigations. And in many cases, autopsies are not performed.

In addition to the wide variability in expertise and data collection, overdoses are typically not reported to the CDC until four months after the date of the death, sometimes longer. In its most recent provisional count, the CDC acknowledged that its overdose data may underestimate the actual number of deaths.

“Some states may have longer than usual delays in submitting drug overdose deaths. In particular, North Carolina is experiencing substantial delays in the resolution of pending records by the medical examiner’s office. Recent trends may underestimate the death count in affected states and this potential impact should be considered when comparing results for states to previous months,” the CDC said.

Percent Change in Drug Overdose Deaths (April 2023 to April 2024)

SOURCE: CDC

Reported vs Predicted

Because the provisional counts are often incomplete and the causes of many deaths are “pending investigation,” the CDC maintains two different data sets. One is the number of “reported” cases, and the other is the “predicted” number of deaths. The latter is where the 10% decline comes from.

The number of reported drug deaths is even lower than the predicted ones, suggesting there has been a 12.2% decline in overdoses nationwide. But that number is also misleading because it is based on incomplete data.

Take North Carolina, for example. For the most recent 12-month period ending in April, North Carolina reported 2,512 drug deaths, compared to 4,317 overdoses from the year before. That’s a whopping decrease of nearly 42 percent!

No one believes that number is real and will hold up over time. Not even Nora Volkow.

North Carolina is not an outlier. Reported drug deaths in Nebraska are down nearly 30 percent, but the data from there is considered “underreported due to incomplete data.” The same is true for Ohio, Pennsylvania and Michigan, where reported drug deaths are down about 20 percent. Big states like that can sway nationwide estimates.

Meanwhile, reported drug deaths are up in several western states: +42% in Alaska, +15% in Oregon, +13% in Nevada, +10% in Washington and +7% in Utah. It’s hard to square those numbers with any national trend.

“Utah’s trends haven’t aligned with national trends for some time. We plateaued while overdoses increased significantly at the national level, especially during the pandemic,” Megan Broekemeier, an overdose research coordinator for the Utah Department of Health and Human Services, told the Deseret News. “We haven’t seen statistically significant changes in the rate yet.”

‘The Dip in Overdoses Is Real’

To be fair, some of the overdose-related data is encouraging and suggest that drug deaths are in fact declining.

In a blog that tracks health data trends, Nabarun Dasgupta, PhD, a drug researcher and scientist at the University of North Carolina, reported a nationwide drop in ER visits and EMS calls (ambulance runs) involving overdoses. He estimates that non-fatal overdoses have fallen -15% to -20% nationwide

“A 15-20% decrease in non-fatal overdose and a 10% decrease in fatal overdose is a major impact. There is barely any public health intervention that has credibly achieved this magnitude of decrease,” wrote Dasgupta. “Our conclusion is that the dip in overdoses is real, and not a data artifact. It remains to be seen how long it will be sustained.”

Dasgupta attributes the decline to several possible factors, such as wider access to the overdose recovery drug naloxone and increased law enforcement seizures of illicit fentanyl.

He does not think the decline in opioid prescribing has anything to do with the drop in overdoses. Deaths linked to opioid pain medication have remained flat for nearly a decade, even as prescribing levels fell to 20-year lows.

“Let's put one hypothesis to rest: Reductions in opioid analgesic prescribing is not driving the changes in overdose rates. We've studied it, and that's not what is driving current fentanyl overdoses,” says Dasgupta.    

The CDC has a checkered history when it comes to tracking overdose deaths. When the agency released its controversial 2016 opioid guideline, it laid the blame for rising overdose deaths squarely on opioid analgesics.

“Overprescribing opioids – largely for chronic pain – is a key driver of America’s drug overdose epidemic,” said then-CDC director Dr. Thomas Frieden, a claim based on weak evidence and false assumptions.

Two years later, after millions of pain patients had their opioid doses reduced or cutoff, the CDC admitted that illicit fentanyl was driving the overdose crisis and that it mistakenly classified many fentanyl deaths as overdoses caused by prescription opioids.The death toll from prescription opioids in 2016 was nearly cut in half — from 32,445 down to 17,087 — when the deaths were reclassified as fentanyl-related.

The CDC says its data collection and analysis have improved in recent years, but they still come with a disclaimer that the monthly provisional counts “may not include all deaths that occurred” and are “subject to change.”

"I think we have to be careful when we get optimistic and see a slight drop in overdose deaths," said Dan Salter, Director of the North Carolina Office of National Drug Control Policy, told NPR. "The last thing we want to do is spike the ball."

Weak Evidence Antidepressants Treat Pain in Older Adults

By Crystal Lindell

New research shows that there’s not much evidence that antidepressants actually work at treating pain in people over 65 years old. 

The study, which comes out of the University of Sydney in Australia, is concerning because older adults with chronic pain are often prescribed antidepressants instead of pain medication. 

However, in a frustrating conclusion, the authors still do not recommend the one medication that is proven to treat pain in older adults: Opioids. 

Instead, they suggest that doctors use a “multidimensional approach using non-pharmacological strategies, such as physical exercise and cognitive behavior therapy.” 

In other words, they essentially conclude that pain patients should get no medication.

However, I am glad that more research is coming out to expose how ineffective antidepressants usually are at treating pain. That class of medication has long been held up as an opioid alternative, despite the fact that many patients don’t get much relief from them. 

The researchers found that international guidelines that recommend antidepressants for chronic pain are heavily based on studies that either exclude older adults or include only a small number of them.  

The researchers found that in the last 40 years there have been just 15 clinical trials globally that focused on the use of antidepressants for pain in older people. And many of them were industry-funded trials with fewer than 100 participants.

The authors say their research fills a much-needed information gap, by bringing together the data from these trials to look at the efficacy and adverse effects of antidepressants for acute and chronic pain in older adults..

They found a lack of evidence to support the use of antidepressants for most pain conditions – despite the fact that they are often recommended in clinical guidelines. And none of the research they analyzed looked at the effectiveness of antidepressants for acute pain, such as shingles or muscular pain.

“These medicines are being prescribed to remedy patients' pain, despite the lack of evidence to adequately inform their use,” said co-author Dr. Christina Abdel Shaheed, an Associate Professor at the University of Sydney’s Institute for Musculoskeletal Health.

The findings mirror those of a recent study in the United Kingdom, which found that there is “no reliable evidence for the long‐term efficacy of any antidepressant, and no reliable evidence for the safety of antidepressants for chronic pain at any time point." 

Withdrawal and Other Side Effects

Shaheed says the potential harms of antidepressants in older people are well documented, and should be factored into any decisions about prescribing the medications. The study found that people taking antidepressants experienced more side effects effects, such as falling, dizziness, and a higher risk of being injured. The potential withdrawal if patients abruptly stop taking antidepressants can also be severe.

The study found that duloxetine, which is sold under that brand names Cymbalta and Yentreve, was able to relieve osteoarthritis knee pain in older adults during the intermediate term, but not short-term or long-term.

As a patient who often shares my health issues publicly, I often get messages and questions from readers who are also dealing with chronic pain. Anytime they mention Cymbalta, I pause. 

I had a horrible experience trying to come off Cymbalta, and I don’t think it even helped much with my pain when I was on it. Plus, my columns about the withdrawal experience apparently resonated, because they are among the most-read, liked and commented on articles I’ve ever written. In other words, it’s not just me. 

If Cymbalta or another antidepressant does help someone, I think they should take it. But I don’t think doctors are fully transparent about how bad the withdrawal can be or how little evidence there is that they even help with pain in the first place. 

“For clinicians and patients who might be using or considering duloxetine for knee osteoarthritis, the message is clear: benefits may be seen with a little persistence, but the effects may be small and need to be weighed up against the risk,” said lead author Dr. Sujita Narayan, an Academic Fellow at the Institute for Musculoskeletal Health.

Again, I’m glad the authors are drawing attention to the problems with prescribing antidepressants for pain management. I just find it alarming that they don’t even bother to mention any alternative medications, and instead suggest non-pharmacological treatments. 

Looking back, I guess I took for granted in the early days of opioid-phobia that most people in the medical field at least recognized that giving zero medication for pain was inhumane. That often meant doctors went from prescribing opioids to prescribing antidepressants. It came with a lot of downsides for patients, but at least it was something. 

If the next stage of opioid-phobia really is just “all medications are bad at treating pain,” then things are worse than I thought. And a lot of people are going to be suffering unnecessarily. 

We already have effective treatments, we just need to use them.

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.

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.”

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.

A Company Will Help You Find a Pharmacy That Has Your Meds

By Pat Anson

If you have a prescription for oxycodone, Adderall, Wegovy or Ozempic, there’s a good chance you’ve had trouble getting it filled. That’s because many pharmacies are experiencing shortages of opioids, stimulants for ADHD, and diabetes drugs that have become popular weight-loss medications.  

The shortages are so acute that a recent PNN survey found that 90% of patients with an opioid prescription experienced delays or problems getting it filled. Many had to visit 3 or more pharmacies to find one that had their medication in stock.

“My pharmacy has been unable to order or get my medication for me for over 6 months now and they are unsure when they'll be able to order or get it for me again,” one patient told us.

“Having to call pharmacies is ridiculous,” said another. “You sit on the phone for 20 minutes just to find out they don’t have your medication.”

Peter Daggett knows all about the stress and anxiety that come with not being able to get a prescription filled. He and his friend, Parth Shah, have firsthand experience with the “pharmacy crawl.”

“We were both diagnosed with ADHD at a younger age, and as many people like us taking stimulant medication, we struggled to find pharmacies that had our medications in stock,” said Daggett. “I was banging my head against the wall. I couldn’t get my medications. I didn't have time to call pharmacies for three hours. I didn't have time to call 100 pharmacies to find one that has my medication.

“And I said to Parth, ‘I’d probably pay somebody 50 bucks if they go find this medication for me.’ And he said, ‘Maybe some other people would, too.’ So we decided to test this out and see if it was something that people wanted. And there were tons and tons of people right out of the gate that really wanted a service like this to exist.”

That’s when Dagget and Shah launched Medfinder, an online company that helps patients find local pharmacies that have their medications in stock. So far this year, they’ve helped over 6,000 patients get their prescriptions filled.  

Medfinder recently started advertising on Facebook and through Google’s advertising platform. Its pharmacy-finding service is available in all 50 states and is growing quickly.

“Our team will go and contact as many pharmacies as it takes to find a pharmacy that has the patient's medications in stock and is willing to dispense it. That will cover any geographic range that the patient wants,” Daggett explained.

“Generally, what we'll do is patients will come in, they'll put their zip code in, and then we'll start searching in the nearby radius. Once we find the pharmacy that has the patient's medication in stock, we'll text that patient (the name and location of) the pharmacy. Then we wait to hear back from the patient.”

MEDFINDER AD

A search for one medication costs $50, but Medfinder has sliding rate plans that can reduce the cost of each search to $30. Fees will be refunded if no pharmacy is found within five business days, but that doesn’t happen often. Daggett says the company has a 99% success rate and is usually able to find a pharmacy within 90 minutes.  

In addition to patients, Medfinder also wants to form partnerships with prescribers. That can save doctors the time and hassle of writing another prescription for the same drug when a patient’s initial search for a pharmacy doesn’t pan out. Once a pharmacy is found through Medfinder, the prescriber is prompted to send the prescription directly to them electronically.

Ozempic, Wegovy and other diabetes/weight loss drugs are Medfinder’s most widely requested medications, followed by ADHD stimulants. Opioids don’t currently make up a big part of the company’s business, but Daggett says they’ve had success finding pharmacies with opioids in stock, despite chronic nationwide shortages of oxycodone and hydrocodone.

“It's extremely rare that we're not able to find a medication for a patient,” he told PNN.       

Election 2024: How Democrats and Republicans Are Failing Pain Patients

By Crystal Lindell

Now that both of the major U.S. political parties have held their national conventions, each has also released their 2024 party platforms outlining where they stand on specific issues. 

The platforms aren’t binding, but they do offer some insight into how the parties, and thus their respective presidential nominees, view different concerns facing the country. 

As a pain patient, I’m especially interested in how the two major parties are handling the topic of opioid medication. And I have to say that neither one seems great on the issue or even aware how millions of pain patients are suffering. 

The Democrats – with Vice President Kamala Harris as their nominee – are still focusing on opioid-phobia, while continuing to ignore the problems many pain patients face. 

The Republicans – with former President Donald Trump as their nominee  – don’t bother even mentioning the word “opioid” in their platform at all. 

Both parties do also have sections about illicit fentanyl coming over the southern border. 

The Democratic platform addresses fentanyl in a section titled “Beating the Opioid Epidemic.” I’m not a fan of how they framed the issue.  

“For too long, the scourge of opioids has torn through our communities, ripping apart families and shattering lives,” the Democratic platform states. “Our nation’s opioid epidemic impacts Americans in every corner of the country, from small towns to large cities to Tribal lands. Far too many Americans have lost loved ones to addiction and overdose. The Biden-Harris Administration is strengthening prevention, investing in treatment, and expanding recovery support services.”

The Democrats then go on to list what they see as their opioid-related achievements. For example, they say the Biden-Harris administration has increased the number of licensed providers who can offer medication-based addiction treatment from 129,000 to 2 million.

They also point out that they have made naloxone, an overdose-prevention drug, available over-the-counter at grocery stores and pharmacies. While I am glad to see expanded access to any medication, I just wish they hadn’t stopped at naloxone. 

The Democrats also brag about how they are “seizing record amounts of fentanyl and securing our border.” They also claim the administration has arrested more people for fentanyl-related crimes in the last two years than in the previous five years combined, while funding “more cutting-edge inspection machines to help detect fentanyl.”

Overall, the language is pretty stigmatizing and doesn’t mention the biggest opioid-related issue that’s actually impacting many people that I know: the fact that patients cannot get pain treatment when they need it. 

Death Penalty for Drug Dealers

Meanwhile, if you search for the word “opioid” in the Republican platform, you get zero results. However, under a section titled "Secure the Border," they say they’ll use the U.S. military to stop fentanyl smugglers.

"We will deploy the U.S. Navy to impose a full Fentanyl Blockade on the waters of our Region – boarding and inspecting ships to look for fentanyl and fentanyl precursors," the GOP platform states.

That framing tracks with how Trump has been addressing the issue. Last month, Trump drastically inflated fentanyl death numbers by claiming that we were “losing 300,000 people a year to fentanyl.” In fact, the number of opioid-related deaths is about 81,000 annually, most of them involving fentanyl. 

In previous statements, Trump said he would impose the death penalty as punishment for “everyone who sells drugs, gets caught selling drugs.”

Those types of lies and exaggeration only serve to further opioid-phobia, making doctors scared to prescribe any opioid-based pain medication for any reason. 

Overall, neither party seems to have pain patient access to opioid medication on their radar at all. While they ignore the issue, patients across the country suffer needlessly from the moral and legal panic about opioids. 

In an ideal world, the political parties would be promising to expand access to pain medications like hydrocodone, which has been greatly restricted over the last decade, despite being relatively safe and effective at treating pain. Instead they are offer a plan to re-educate medical professionals about addiction treatment, while ignoring the very real dangers of not treating pain. 

We seem to be stuck with two parties who refuse to even acknowledge the problems pain patients face, much less address them. 

Patients and Providers Say Cannabis Helps Reduce Opioid Use

By Crystal Lindell

More than half the pain patients certified in New York state’s medical cannabis program say they’re using cannabis as an alternative to opioid medication. 

That’s great news for patients who see real benefits from cannabis, but we have to be careful to avoid further demonizing opioids when data like this is released. Using something as an alternative doesn’t show that it’s necessarily more effective or more helpful. Often, it just means that something is more accessible. 

The data comes from the New York State Office of Cannabis Management’s 2023 Patient and Provider Survey Report, which was recently released. This was a large survey that collected responses from 10,781 patients and 265 providers enrolled in the state’s medical cannabis program. 

“Findings from both the patient and provider surveys demonstrate that medical cannabis is effective for pain management and has the potential to reduce the use of opioids,” the report found.

About 57% of the patients were pain sufferers, making pain the top condition for using cannabis, followed by post-traumatic stress disorder (24%), neuropathy (19%), spasticity (11%), rheumatoid arthritis (11%), inflammatory bowel disease (10%) and cancer (8%).

The survey found that 66% of patients think medical cannabis helped reduce their use of opioids for pain management.

The providers were largely in agreement, with 83% saying “medical cannabis should be used to reduce the use of opioids for pain management” and 75% saying cannabis poses less risk than opioids. 

However, this is where I start to raise my eyebrow a bit. 

It makes me nervous that so many providers see cannabis as being safer than opioids. The fact that 25% of them don’t is also a telling statistic. It means the data on this is unclear.

All substances have side effects. Both patients and providers understand this. In a just world, patients should be able to make the choice about which substances or medications they use, after factoring in their own preferences for what side effects are acceptable as a tradeoff for pain relief. 

Even if it was proven that cannabis is significantly safer than opioids for managing pain, that doesn’t mean it’s just as effective as opioids. Personally, I don’t find cannabis to be very effective at all for treating my pain. I also really dislike how sleepy it makes me. For my life and my needs, opioids remain a much better option. 

I’m lucky enough to have a recurring prescription for opioid medication. But for patients who can’t get an opioid prescription, they don’t truly get a choice or “alternative.” Cannabis may be their only legal option. 

The New York State report also shows me that it’s long past time to make cannabis legal at the federal level. It’s clear now that classifying cannabis as an illegal controlled substance never had any foundation in health concerns. Clearly, cannabis can help treat a large number of medical conditions. And many people get health benefits from using it. 

A lot of drugs that are classified as harmful controlled substances can still be obtained by prescription. And some that are not “controlled” are potentially more dangerous than cannabis. That doesn’t make any sense, but that’s how the system is set up under the Controlled Substance Act. 

The way that cannabis has been slowly legalized across the country should make us take a long look at all of our drug laws. There are many illegal substances, such as psychedelics, that could potentially help people manage health conditions – but only if they had access to them in the same way most Americans can now access medical or recreational cannabis. 

If nothing else though, cannabis’ slow legalization has given me some hope. I can remember even 25 years ago, being in college, listening to guys in dorm rooms ramble on about how cannabis would be legalized someday. I confess I didn’t believe them. At the time, it felt impossible. 

Turns out, I was wrong. Now I just hope we don’t stop at cannabis. 

A New Study of Opioid Addiction Only Muddies the Water Further

By Pat Anson

Over the years, hundreds of studies have been conducted to determine how common it is for a pain patient on long-term opioid therapy to become addicted. Estimates range from less than 1% to more than 80% of patients developing opioid use disorder (OUD), also known as problematic pharmaceutical opioid use (POU).

The wide variation in estimates is largely due to conflicting definitions, terminology, study design and biases. Is a patient misusing or abusing prescription opioids? Do they show signs of dependence or withdrawal? It literally depends which study you read.

New research that tries to settle the matter may have only muddied the water further.

A team of researchers at the University of Bristol conducted a meta-analysis of 148 clinical studies involving over 4.3 million patients in North America and the UK who were treated with opioids for chronic non-cancer pain. The 148 studies were all that was left from nearly 5,300 that were initially screened and rejected for various reasons — which should tell you a lot about the quality of studies that are out there.

“Clinicians and policy makers need a more accurate estimate of the prevalence of problematic opioid use in pain patients so that they can gauge the true extent of the problem, change prescribing guidance if necessary, and develop and implement effective interventions to manage the problem.  Knowing the size of the problem is a necessary step to managing it,” said lead author Kyla Thomas, PhD, Professor of Public Health Medicine at the University of Bristol.

Thomas and her colleagues included studies in their review that reported any sign of POU, such as abuse, tolerance, addiction, dependence, misuse, substance use disorder or “aberrant behavior.” The latter includes seemingly benign behavior like a patient being poorly dressed or unkempt in appearance, canceling or missing an appointment, asking for a specific drug, or even just complaining about their pain.

In some studies, “misuse” was defined so broadly that it included patients who stopped using opioids because their pain went away or they took a pill less often than recommended. A patient like that might be suspected of hoarding or even selling their unused medication.     

In other words, the researchers cast a pretty wide net on what constitutes OUD. And they hauled in a lot of fish.

Their findings, recently published in the journal Addiction, estimate that nearly one in ten pain patients (9.3%) are dependent on opioids and have OUD.

Nearly a third (29.6%) have “signs and symptoms” of dependence and OUD, and over one in five (22%) displayed aberrant behavior.

“Prescription painkiller misuse and addiction are widespread in chronic pain patients” is how the University of Bristol trumpeted the results in a press release, with the lone caveat that “these findings should be interpreted with caution.”

‘OUD Is Everywhere’

Critics of the study were quick to point out that equating dependence with opioid use disorder is misleading at best – the equivalent of a diabetic dependent on insulin being labeled with “insulin use disorder.”

“This is just one more paper, one of zillions, that seizes upon some outcome measures that have poor or no basis in science and that are not in any way indicative of addiction,” says Stephen Nadeau, MD, Professor of Neurology at the University of Florida College of Medicine. “As is so common, it favors the ridiculous notion that OUD is everywhere.”

Nadeau says any patient on daily opioids will experience symptoms of dependence or withdrawal if their medication is suddenly stopped. Neither is a clear sign of addiction or substance use problem, just as a patient asking for a higher dose is not necessarily a symptom of OUD.

“There is never any recognition of the ubiquitous phenomenon of pseudo-addiction: a patient in desperate pain asks for an increase in dosage. Instead of the request being interpreted at face value, the patient is branded with the diagnosis of OUD and booted from the clinic,” Nadeau told PNN.

Being “branded” or stigmatized is something that chronic pain patients like Brett Bradford are all too familiar with. He thinks the new addiction study will only result in more patients being taken off opioids.

“All physicians coming out of med school are being taught these hyper anti-opioid policies. This is only going to fuel things to get worse,” said Bradford. “This madness will not stop until opiates are totally off the market and nobody will be able to get any pain meds for any reason, short of being on their death bed. Maybe. If they are lucky.”