Alarming Study Tries to Automate Labeling of Patients with Opioid Use Disorder

By Crystal Lindell

An alarming new study attempts to automate the process of labeling chronic pain patients with Opioid Use Disorder (OUD), by using a computer to scan doctors’ clinical notes. 

A team of researchers analyzed medical records for over 8,000 patients with chronic pain, and then used an automated process to scan clinical notes from doctors, patient demographics, and diagnostic codes. The automated process was then compared to whether patients had already been given a diagnostic code for OUD. 

The researchers claim that their automated approach out-performed diagnostic codes when it came to finding patients with OUD. The codes are a key part of healthcare and are used by doctors not only to make a diagnosis, but to get reimbursed by insurers for treating patients.  

The authors say the diagnostic codes are “unreliable and underused,” and claim that their automated approach will do a better job predicting which patients are at risk for OUD and which once already have it.

“This automated data extraction technique may facilitate earlier identification of people at risk for and who are experiencing problematic opioid use, and create new opportunities for studying long-term sequelae of opioid pain management,” wrote lead author Alvin Jeffery, PhD, an Assistant Professor in the Department of Biomedical Informatics at Vanderbilt University Medical Center.

Jefferey and his colleagues say chronic pain patients treated with opioids are “at high risk of developing an opioid use disorder,” and cite a single study estimating the risk is as high as 18%. Most research puts the probability much lower, at about 1%.  

There are a number of other alarming things about this research. 

First and foremost, using any sort of automated process to label patients as having opioid use disorder is incredibly dangerous. Especially if that automated process applies the label to more patients than doctors already are. 

Also, the researchers used the “Addictions Behaviors Checklist” to determine if patients have OUD. Unfortunately, that checklist is known for lumping in a lot of patients who simply have untreated or under-treated pain. 

For example, one of the items on the checklist is “patient running out of medications early” – which means anyone who isn’t being prescribed enough pain medication could qualify as having OUD. 

Another criteria on the list is “patient expressing concern about future availability of narcotics” – a normal thing to be worried about when opioid shortages are widespread and opioid-phobia is rampant in the medical community. 

Other red flag terms they search for in doctors’ notes are “hoard,” “stash,” “left over” and “storing.” This also overlooks the fact that prescription opioids can be difficult to get, causing  many patients to keep leftover ones, just in case they needed them in the future. A recent PNN survey found that 32% of patients hoarded unused opioids. 

Once a patient gets labeled with OUD, it can quite literally ruin their lives by making it more difficult for them to get their pain adequately treated. That doesn’t just apply to patients with chronic pain. If a surgical patient experiencing post-op pain (as nearly all do) has “possible OUD” in their chart, doctors are much less likely to prescribe opioid pain medication. 

I genuinely worry that we are reaching a point where computers and artificial intelligence will be used en masse to label patients with damaging mental health diagnoses like OUD. And if that takes root, there won’t be any way for patients to counter the diagnosis. 

In fact, one of the biggest problems in healthcare is that there is no right to due process. Once you are given a medical verdict, so to speak, you are often stuck with it. 

We should all be worried that these types of automated diagnostic tools will also be expanded beyond opioid users to label other patients with stigmatizing mental health conditions that impact the quality of the medical care they receive going forward.

At this point, I’m not sure what patients can even do to stop this from happening, but my hope is that bringing more awareness to the issue will at least slow its progression. 

I personally would judge any doctors who would rely on any sort of automated process to give a patient a dangerous label like OUD, even if such a process is mandated by the hospital they work for, or even the government. 

I hope that doctors will have the moral fortitude to fight back on these types of things. Although if the medical community’s recent history with opioids is an indication, I’m not convinced most of them will stand up for their patients. 

Trump’s Tariffs Won’t Stop Illicit Drug Use

By Rodney Coates

Americans consume more illicit drugs per capita than anyone else in the world; about 6% of the U.S. population uses them regularly.

One such drug, fentanyl – a synthetic opioid that’s 50 to 100 times more potent than morphine – is the leading reason U.S. overdose deaths have surged in recent years. While the rate of fentanyl overdose deaths has dipped a bit recently, it’s still vastly higher than it was just five years ago.

Ending the fentanyl crisis won’t be easy. The U.S. has an addiction problem that spans decades – long predating the rise of fentanyl – and countless attempts to regulate, legislate and incarcerate have done little to reduce drug consumption. Meanwhile, the opioid crisis alone costs Americans tens of billions of dollars each year.

With past policies having failed to curb fentanyl deaths, President Donald Trump is turning to another tool to fight America’s drug problem: trade policy.

During his presidential campaign, Trump pledged to impose tariffs on Canada and Mexico if they didn’t halt the flow of drugs across U.S. borders, and on China if it didn’t do more to crack down on the production of chemicals used to make fentanyl. Trump reiterated his plan on his first day back in office, and on Feb. 1, he made good on that threat, imposing tariffs on all three counties and citing fentanyl as a key reason.

Speaking as a professor who studies social policy, I think both fentanyl and the proposed import taxes represent significant threats to the U.S. While the human toll of fentanyl is undeniable, the real question is whether tariffs will work – or worsen what’s already a crisis.

In 2021, more than 107,000 Americans died from overdoses – the most ever recorded – and nearly seven out of 10 deaths involved fentanyl or similar synthetic opioids.

In 2022, fentanyl was killing an average of 200 people each day. And while fentanyl deaths declined slightly in 2023, nearly 75,000 Americans still died from synthetic opioids that year. In March of that year – the most recent for which full-year data on overdose deaths is available – the then-secretary of homeland security declared fentanyl to be “the single greatest challenge we face as a country.”

Drug Regulation Doesn’t Work

But history shows that government efforts to curb drug use often have little success.

The first real attempt to regulate drugs in the U.S. occurred in 1890, when, amid rampant drug abuse, Congress enacted a law taxing morphine and opium. In the years that followed, cocaine use skyrocketed, rising 700% between 1890 and 1902. Cocaine was so popular, it was even found in drinks such as Coca-Cola, from which it got its name.

This was followed by a 1909 act banning the smoking of opium, and, in 1937, the “Marihuana Tax Act.” The most comprehensive package of laws was instituted with the Controlled Substances Act of 1970, which classified drugs into five categories based on their medical uses and potential for abuse or dependence.

A year later, then-President Richard Nixon launched the “War on Drugs” and declared drug abuse as “public enemy No. 1.” And in 1986, Congress passed the Anti-Drug Abuse Act, directing US$1.7 billion for drug enforcement and control.

These policies have generally failed to curb drug supply and use, while also causing significant harm to people and communities of color. For example, between 1980 and 1997, the number of incarcerations for nonviolent drug offenses went from 50,000 to 400,000. But these policies hardly put a dent in consumption. The share of high school seniors using drugs dipped only slightly over the same period, from 65% in 1980 to 58% in 1997.

Tariffs Can Backfire

In short, past U.S. efforts to reduce illegal drug use haven’t been especially effective. Now, it looks like the U.S. is shifting toward using tariffs – but research suggests that those will not lead to better outcomes either, and could actually cause considerable harm.

America’s experiments with tariffs can be traced back to the founding era with the passage of the Tariff Act of 1789. This long history has shown that tariffs, industrial subsidies and protectionist policies don’t do much to stimulate broad economic growth at home – but they raise prices for consumers and can even lead to global economic instability.

History also shows that tariffs don’t work especially well as negotiating tools, failing to effect significant policy changes in target countries. Economists generally agree that the costs of tariffs outweigh the benefits.

Over the course of Trump’s first term, the average effective tariff rate on Chinese imports went from 3% to 11%. But while imports from China fell slightly, the overall trade relationship didn’t change much: China remains the second-largest supplier of goods to the U.S.

The tariffs did have some benefit – for Vietnam and other nearby countries with relatively low labor costs. Essentially, the tariffs on China caused production to shift, with global companies investing billions of dollars in competitor nations.

This isn’t the first time Trump has used trade policy to pressure China on fentanyl – he did so in his first term. But while China made some policy changes in response, such as adding fentanyl to its controlled substances list in 2019, fentanyl deaths in the U.S. continued to rise. Currently, China still ranks as the No. 1 producer of fentanyl precursors, or chemicals used to produce illicit fentanyl. And there are others in the business: India, over that same period, has become a major producer of fentanyl.

Drugs have been pervasive throughout U.S. history. And when you investigate this history and look at how other nations are dealing with this problem rather than criminalization, the Swiss and French have approached it as an addiction problem that could be treated. They realized that demand is what fuels the illicit market. And as any economist will tell you, supply will find a way if you don’t limit the demand. That’s why treatment works and bans don’t.

The U.S. government’s ability to control the production of these drugs is limited at best. The problem is that new chemical products will continually be produced. Essentially, failure to restrict demand only places bandages on hemorrhaging wounds. What the U.S. needs is a more systematic approach to deal with the demand that’s fueling the drug crisis.

Rodney Coates, PhD, is a public sociologist and Professor of Critical Race and Ethnic Studies at Miami University

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

RFK Jr. Wants to Create Drug Rehab ‘Wellness Farms’

By Pat Anson

Confirmation hearings for Robert F. Kennedy Jr., President Trump’s nominee to be Secretary of Health and Human Services, are expected to begin next week, with senators likely to ask about his controversial views on vaccines, fluoride, abortion and other hot-button health issues.  

Less well known is Kennedy’s ambitious plan for drug rehabilitation “wellness farms” for people addicted to illicit drugs or prescription medications such as opioids, antidepressants, stimulants and anti-anxiety medications. Kennedy outlined his plans to treat addiction and “re-parent” people with substance use problems during a “Latino Town Hall” last July, when he was running for president and had yet to endorse Trump.

“I’m going to make it so people can go, if you’re convicted of a drug offense, or if you have a drug problem, you can go to one of these places for free,” said Kennedy, adding that he would pay for the wellness farms with a tax on cannabis sales, if and when marijuana is removed as a prohibited Schedule One controlled substance.    

“I’m going to move it off Schedule One and I’m going to start collecting taxes on it. That’s going to bring in $8.5 billion dollars in revenue. I’m going to dedicate that revenue to creating wellness farms, drug rehabilitation farms, in rural areas all over this country.”

Kennedy released a documentary called “Recovering America” last year, in which he tours the country looking for innovative drug treatment programs. The issue is close to his heart because Kennedy was addicted to heroin as a young man. He’s been in recovery for 40 years and regularly attends 12-step meetings.

“We have a whole generation of kids who are dispossessed, they’re alienated, they’re marginalized, their suicide rates are exploding. The second largest killer for young people is drug addiction,” Kennedy said.

“I’m going to create these wellness farms where they can go to get off of illegal drugs, off of opiates, but also legal drugs, psychiatric drugs, if they want to, to get off of SSRIs, to get off of benzos, to get off of Adderall, and to spend time, as much time as they need — three or four years if they need it — to learn to get re-parented, to reconnect with communities, to understand how to talk to people.”

Participants at the wellness farms would also receive job training and grow their own organic food. Kennedy has long blamed pesticides and processed food for America’s “chronic disease epidemic.”

If confirmed as HHS secretary, Kennedy would oversee a vast bureaucracy and supervise agencies such as the Food and Drug Administration, Centers for Medicare and Medicaid Services, National Institutes of Health, and the Centers for Disease Control and Prevention.

It’s not clear what his views are about the CDC’s opioid guideline, which led to many patients in pain losing access to opioids. But Kennedy has been outspoken about the influence drug makers and lobbyists have on public health policy, saying Trump gave him instructions to end the “corruption and the conflicts” at federal health agencies.

“FDA’s war on public health is about to end,” Kennedy wrote in an October 25 tweet. “If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags.”

Trump also said he would let Kennedy “go wild” on healthcare, but according to Politico, his transition team is intent on surrounding RFK Jr. at HHS with conservative aides who have more experience in government and remain loyal to Trump.

The Washington Post reported that the Office of Government Ethics is still looking into Kennedy's financial disclosure statements, which were recently amended. That may delay his confirmation hearings until late January.

FDA Approved Genetic Test for Opioid Use Disorder Is Flawed

By Crystal Lindell

An FDA-approved test that claims it can identify genetic risk for opioid use disorder (OUD) is so flawed as to basically be useless – at least according to a new study published in JAMA.

The genetic test, which is sold under the brand name “AvertD” by AutoGenomics, was given approval by the Food and Drug Administration in 2023. The test claims it can use 15 genetic variants to identify people at risk for misusing opioids. 

According to AutoGenomics, the variants “may be associated with an elevated genetic risk for developing OUD.” However, the company provides no citations to support the associations between the brain reward pathways and OUD — meaning the test’s foundation itself seems to be flawed.

However, the authors took the premise of the AvertD test seriously, and set out to find if it could actually predict OUD. They looked at a diverse sample of more than 450,000 “opioid-exposed individuals” (including 33,669 individuals with OUD), and found no evidence to support the use of the AvertD test. 

Specifically, they found both high rates of false positives and false negatives, with 47 out of 100 predicated cases or controls being incorrect. 

“Notably, clinicians could better predict OUD risk using an individual’s age and sex than the 15 genetic variants,” researchers said.

The fact that the test doesn’t seem to work could have dangerous consequences for pain patients. The fear is that they will be used to deny patients opioid medications simply because their “genetic markers” show them to be in a high-risk patient group. 

The study authors directly point this out, writing: “False-positive findings can contribute to stigma, cause patients undue concern, and bias health care decisions.”

They also point out the potential harms of a false-negative finding, which "could give patients and prescribers a false sense of security regarding opioid use and lead to inadequate treatment plans."

The fact that this genetic test has gotten as far as it has raises questions about the FDA approval process. 

The problems don’t stop there though. Another major flaw in both the study and the genetic testing is that “Opioid Use Disorder” has such murky diagnostic criteria, that it’s difficult to take it seriously. It’s basically a set of vague symptoms, as opposed to a clear-cut diagnosis, despite what some have been led to believe. 

A CDC fact sheet for OUD Diagnostic Criteria is a mishmash of vague symptoms, such as tolerance and withdrawal, that could just be the result of untreated or poorly treated physical pain. 

Things like “taking opioids in larger amounts or over a longer period of time than intended” and “having a persistent desire or unsuccessful attempts to reduce or control opioid use.”

The CDC also lists "withdrawal symptoms" as one of the diagnostic criteria for OUD, which is something that people can experience from rapid tapering without having OUD.

The CDC then includes the odd disclaimer that “tolerance and withdrawal are not considered” when opioids are taken under appropriate medical supervision.

So in a country that does not guarantee healthcare, you can avoid an OUD diagnosis if you can afford to find a doctor willing to prescribe opioids to you. But if you can’t find a doctor or abandoned by one — and then have withdrawal symptoms — you must have a disorder.

That doesn’t sound like a medical diagnosis to me. That sounds like classism.

A patient needs just to have just two of the OUD criteria to have “mild OUD” – a benchmark that has the sweeping effect of including a large number of patients taking opioids for chronic pain. 

It’s no wonder that a genetic test claiming to be able to predict OUD would be so flawed, given how flawed the diagnosis of OUD is to begin with. 

Perhaps instead of trying to guess potential risks for a vague disorder, the FDA should be focused on treatments already proven effective for people who want to stop their opioid use, like expanding methadone access. 

The whole situation reminds me of the Tom Cruise-movie Minority Report, a futuristic thriller in which a specialized police department called Precrime “apprehends criminals by use of foreknowledge provided by three psychics.”

Denying people pain medication based on a flawed genetic test that falsely claims it can predict the future is basically the same thing. And it’s just as evil in real life as it is in the movie.  

How Do We Decide Which Drugs Are Bad and Which Ones Are Good?

By Crystal Lindell

I was in elementary school during the height of the original DARE campaign. I vividly remember fully uniformed police officers coming into my classrooms to share the Drug Abuse Resistance Education’s program’s very direct message: “DARE to say no to drugs!”

My friends and I all got free black T-shirts with the bold red DARE slogan splashed across it, and every year we signed a pledge promising to never use drugs.  

What qualified something as a “drug” was a little more difficult to discern though. 

Back in the 1990s there was a lot of talk about “pot” and “dope,” so I figured those were both bad, although as a 10-year-old living in a pre-Google world, I didn’t really know what either one was and I didn’t know how to find out.

I also remember lots of conversations about alcohol and cigarettes, but those were apparently only “drugs” if you were under a certain age, seeing as how a lot of adults I knew used them. 

How effective DARE was is still hotly debated, but there is one part that seems to have left a lasting legacy: Most Americans still think anything labeled as a “drug” by cops is inherently bad and must therefore be greatly restricted and regulated.  

Now that I’m in my 40s, I am much less accepting of the blanket “drugs are bad” messages that law enforcement agencies spread to my peers and me back in the day. 

As it turns out, “drugs” can mean a lot of things, and the reasons we are given for why some are bad and some are good are murky at best. 

If you ask most adults in the United States to define “drugs,” they’ll often reach for whatever legal categories the police have neatly provided. Opioids and stimulants are “drugs” because they are heavily regulated, but NSAIDS and acetaminophen aren’t because you can buy them over the counter at Walgreens. 

If you push them to consider the definition beyond what law enforcement has provided, they’ll usually go right to “things that are addictive.” If you point out that caffeine is extremely addictive though, they’ll shrug that off with “well that’s different.” 

I’ll also often hear people defend their morning latte with something along the lines of “well nobody’s ever resorted to sex work to buy an espresso," as though that in and of itself makes coffee superior to a morning Adderall. 

Aside from the fact that this logic shames sex workers, it also leaves out the very important reason that people don’t have to resort to extremes to access coffee: Caffeine is legally sold over the counter. 

If medications like hydrocodone or Adderall were sold in the same way as your morning coffee, they would also be cheap, safe and easily available – and thus people wouldn’t have to resort to extremes to be able to afford them. 

Beyond that, we also have decided, as a culture, that lots of very addictive things should be sold over the counter. 

In addition to coffee, adults can purchase alcohol and nicotine with no problem, despite how deadly both of those are. What makes them different from Adderall or even Oxycontin? Have you ever really considered the question? 

If anything, don't drunk driving and second-hand smoke potentially make alcohol and nicotine worse, since there’s so much danger to non-users?

Personally, as a pain patient who has also seen many loved ones suffer as a result of an onslaught of opioid-phobic regulations over the last decade, I will admit to having been radicalized on this issue. 

I think most of the drug laws we have on the books are far too restrictive, and most substances should be sold the same way alcohol and coffee are: Over the counter. 

However, I can appreciate the fact that this is a radical position in the United States. After all, we’ve all been subjected to heavy anti-drug propaganda for decades now, going back to Nancy Reagan first telling kids to “Just Say No” way back in 1982. 

I’d encourage you to think critically about such a simplistic slogan though. When it comes to which substances people want to consume and why, it’s not quite so easy to know when a drug is bad and when it’s good. 

In fact, I have a saying of my own that I like to share during conversations about drug legalization. I believe people use the drugs they need and, absent that, they’ll use the drugs they have access to.

So if a drug is something you need, is it really something you should “Just say no” to?

ER Opioids ‘Extremely Unlikely’ to Lead to Addiction

By Pat Anson

Many patients in pain have horror stories to share about their experiences in hospital emergency rooms, where they’ve been treated as drug seekers and denied opioid medication.

“I had a broken arm and was given nothing for pain when leaving the emergency room,” one patient told us. “They now treat everyone like a drug seeking addict even if you have legitimate pain!”

“My last ER visit has caused me PTSD. It was awful they put me in a room and turned the light off and left me there for hours,” said another.

“The emergency rooms are horrible,” said a patient with a fractured rib. “I wasn’t even asking the ER for meds. I wanted an x-ray or something because I was in excruciating pain.”

Are fears about opioid addiction justified? A new study found that the risk of developing opioid use disorder after being treated with intravenous opioids in the ER is quite low – less than one-tenth of one percent (0.002%).

Out of 506 patients treated with IV opioids in two Bronx emergency rooms, only one met the criteria for long-term or persistent opioid use six months later.

“These data suggest that the use of IV opioids for acute pain among opioid-naive patients is extremely unlikely to result in persistent opioid use,” wrote lead author Eddie Irizarry, MD, an emergency medicine physician at Montefiore Medical Center.

“Opioid naïve” means the patients had never taken opioids before or only used the drugs infrequently.

The study, recently published in The Journal of Emergency Medicine, defines persistent use as filling six or more opioid prescriptions in the 6 months after an ER visit, or an average of one prescription per month.

The most frequently reported IV opioid administered in the ER was morphine (94%), followed by hydromorphone (4%) or a combination of both morphine and hydromorphone (2%). The researchers noted that most of the morphine doses were “relatively modest.”

After being treated in the ER, 63 of the patients (12%) received an opioid prescription on discharge.   

The researchers cautioned that opioids should be used “judiciously” and that many ER patients could be treated with non-opioid analgesics such as acetaminophen. But they could find no evidence that IV opioids should be routinely denied in the ER.

“We are not aware of compelling data to support denying parenteral opioids to opioid-naïve patients who are suffering from severe acute pain,” said Irizarry.   

The research mirrors the findings from a 2017 Mayo Clinic study, which found that the risk of long-term opioid use is lower for ER patients than it is for patients treated in other medical settings. In the Mayo study, 1.1% of opioid naive patients became long term users. That compares to 2% of patients who were prescribed opioids in non-emergency settings.

Survey Finds Patients and Doctors Unsatisfied with Treatments for Acute Pain

By Pat Anson

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

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

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

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

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

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

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

• 70% Limited their ability to walk and exercise

• 69% Limited their sleep

• 65% Limited their hobby or leisure activity

• 65% Made them feel irritable or emotionally drained

• Missed an average of 19 work days annually

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

• 49% of patients concerned about opioid addiction

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

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

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

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

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

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

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

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

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

Poppy Seeds Draw More Scrutiny for Addiction Risk

By David Hilzenrath, Healthbeat

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Unwashed Seeds More Potent

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.”

Genes May Explain Why Gabapentin Works for Some Pain Patients

By Pat Anson

Over the years, gabapentin (Neurontin) has been prescribed for dozens of health conditions, from epilepsy and fibromyalgia to depression and post-operative pain. It’s even been used to treat bipolar disorder. Gabapentin has been marketed for so many different conditions – at times illegally -- that a pharmaceutical company executive infamously referred to the drug as “snake oil.”

Even though it’s been approved for medical use for over 30 years, the UK’s National Health Service admits it’s still “not clear exactly how gabapentin works.”

A new study may finally help explain why gabapentin is an effective pain medication for some patients and an addictive drug with unwelcome side effects for many others.

It could be all in the genes.

Researchers at the University of Edinburgh took another look at a previous study of women with chronic pelvic pain to see why gabapentin worked no better than a placebo for most, but was a moderately effective pain reliever for about 40% of them.

Researchers took saliva samples from 71 women who participated in the study -- 29 who responded to gabapentin and 42 who had no improvement -- and found that the responders were more likely to have a variation of the gene Neuregulin 3 (NRG3). The gene is primarily expressed in the brain, spinal cord and central nervous system, and helps regulate pain sensation and transmission.

The findings, recently published in the journal iScience, may explain why gabapentin works for some women with chronic pelvic pain.

"A genetic factor that can predict how well gabapentin will work in patients offers the prospect of tailored treatment, and provides invaluable insights into understanding chronic pain. We hope eventually to use this genetic marker to optimize personalized treatment decisions and minimize adverse effects for women with chronic pelvic pain," wrote lead author Scott Mackenzie, MD, from the University of Edinburgh's Centre for Reproductive Health.

The study also has implications for other chronic pain conditions. Further research is needed to confirm the findings, but researchers say a genetic test for NRG3 could help limit the use of gabapentin to people who actually benefit from the drug.

"Isolating this single genetic marker is an important discovery that could ultimately help refine treatments for millions of women worldwide who suffer from chronic pelvic pain, as well as increasing our understanding of its role in other pain conditions. We believe this is an exciting opportunity for collaboration with a commercial partner who can help translate the research into a clinical setting," said Susan Bodie, PhD, Head of Business Development for the College of Medicine and Veterinary Medicine at the University of Edinburgh.

Gabapentin and other nerve drugs like pregabalin (Lyrica) have come under increased scrutiny in the UK because they are increasingly involved in overdose deaths.  

A recent analysis of drug tests suggests that gabapentin is also being misused in the U.S. Gabapentin was found in in over 13% of urine samples that tested positive for fentanyl -- about twice the number of drug tests in which prescription opioids were found.

Despite the risks of side effects and addiction, gabapentin is increasingly prescribed “off-label” for conditions it is not approved to treat, such as dental pain. A 2019 study found little evidence that gabapentin and pregabalin should be used for pain and said their effectiveness was often exaggerated by prescribing guidelines.

The CDC’s revised opioid guideline says gabapentin and pregabalin can have “small to moderate improvements” on pain, but with a moderate risk of side effects.

Drug Prohibition Is Making the Overdose Crisis Worse

By Drs. Kora DeBeck and Perry Kendall

Should heroin and cocaine be legally available to people who need and want them? If we are serious about stopping the crisis of drug overdose deaths, that is exactly the kind of profound change we need. Yes, extensive regulations would be necessary. In fact, the whole point of regulating drug production and sales is that we can better control what is being sold and to whom.

After British Columbia’s Provincial Health Officer Dr. Bonnie Henry testified to the all-party health committee in Ottawa in May that regulating these controlled drugs would minimize harms, B.C. Premier David Eby said he disagreed. He is quoted saying “in a reality-based, real-world level, (it) doesn’t make any sense.” But does our current approach of drug prohibition “make sense?”

Since the overdose crisis was declared in 2016, illicit drug toxicity deaths have become the leading cause of unnatural death in B.C. and the leading cause of death from all causes for those aged 10 to 59. More than 44,000 people have died from drug poisoning in Canada since 2016, and more than one-third of those were in B.C. An average of 22 people are dying every day in Canada because the illicit supply of drugs is toxic.

Toxic Drug Supply

Why is the drug supply so toxic? Because we are letting organized crime manufacture drugs instead of regulated licensed industries that are required to follow health and safety standards.

In the context of drug prohibition, organized crime and drug cartels are incentivized to make highly potent products because it is cheaper and hence more profitable. This is what happened during alcohol prohibition in the 1920s. Organized crime ran rampant, and people were poisoned because there were no health and safety standards for production.

The failure of alcohol prohibition in meeting its key objectives of eliminating the supply and demand of alcohol are the same failures of drug prohibition. Illegal drugs are easy to find regardless of their illegal status. Reliable estimates are that 225,000 people are using illegal substances in B.C.

What is the way out? Our knowledge of research evidence and decades of collective experience — including as a researcher (Kora DeBeck), a B.C. provincial health officer (Perry Kendall) and chief coroner (Lisa Lapointe) during the overdose crisis — brings us to drug regulation. When we regulate a substance, we have the most control over its production, distribution and consumption.

Lessons From Tobacco

Some may argue that regulating drugs sends the “wrong message” and will encourage drug use, most concerningly among young people. However, if we look to lessons from tobacco regulation, we can see that public health-based regulations can actually be strong and effective substance-use deterrents.

By strictly controlling tobacco marketing, packaging, purchase price, purchase age and consumption locations alongside educating people about the health risks, tobacco consumption and associated health harms have been significantly reduced without all the additional risks of banning tobacco products (for example, criminal black markets controlling production and sales).

The same kinds of regulatory tools would be available to control the use of currently illegal drugs if we moved from prohibition to regulation.

Addiction Treatment Not Enough

But what about addiction treatment? Isn’t that what we really need? While it’s true that eliminating wait times and increasing access to effective, evidence-based treatment are critically important and much needed, the reality is that many people who use drugs don’t have an addiction and many others are not currently seeking treatment. Yet all people who use drugs face the deadly consequences of an unregulated toxic drug supply.

It is also important to remember that addiction recovery is complex and relapse is common in the recovery journey. In today’s toxic drug environment, people who relapse after a period of abstinence face a significantly higher risk of death due to their reduced tolerance. We also know that substance treatment is not regulated or standardized, and treatment outcomes are not reported.

While supporting people to recovery is important and can be lifesaving, addiction treatment is not the straightforward solution many believe it should be. Thousands of lives remain at risk every day.

A Regulated Drug Supply

Taking the production and sale of currently illegal drugs away from organized crime and drug cartels is the most promising way to keep our kids and communities safe. With strict health and safety standards for the production of these drugs and stringent public health-based regulations on their distribution and sale, we have the best shot at reversing the carnage of overdose fatalities and managing drug-related harms.

Regulating drugs may seem to some like a radical proposition but governments regulate the production and distribution of potentially dangerous goods all the time. The regulation of firearms in Canada includes licensing that requires passing a firearms safety course. Mandatory ingredient lists that disclose the amount of sugar, sodium and fat in the foods we eat is another example of a government regulation that is designed to protect the public and provide information that may shape consumption patterns and reduce health risks.

Implementing an effective regulatory framework for currently illegal drugs will be a complex undertaking requiring close monitoring and evaluation and inevitably corrections and revisions along the way. While the task may appear daunting, allowing overdose deaths to continue at the current rate is unconscionable.

Transformational and life-saving drug regulation is urgently required because, borrowing terminology from Premier Eby, at the “reality-based, real-world level,” our current approach is a catastrophic failure.

Kora DeBeck, PhD, is a Distinguished Associate Professor in the School of Public Policy at Simon Fraser University and a Research Scientist at the BC Centre on Substance Use.

Perry Kendall is a Clinical Professor in the Faculty of Medicine, School of Population and Public Health at the University of British Columbia. He is also a former Provincial Health Officer for BC

This article was also co-authored by Lisa Lapointe, who was BC’s Chief Coroner from 2011 to 2024.

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

Naltrexone Shortage Disrupts Addiction Treatment

By Pat Anson, PNN Editor

An inexpensive drug used to manage chronic pain and treat substance use disorders has joined the growing list of medications that are in short supply in the United States.

The Food and Drug Administration and the American Society of Health-System Pharmacists (ASHP) both recently added naltrexone tablets to their drug shortage lists. It’s not clear what caused the shortage, but the ASHP says “there is insufficient supply for usual ordering.”  

Naltrexone is FDA-approved to treat both alcohol and opioid use disorder, and is also used off-label in low doses to treat some chronic pain conditions.

In 50mg doses, naltrexone blocks opioid receptors in the brain and reduces cravings for opiates or alcohol. But in smaller doses of 5mg or less, patients have found low-dose naltrexone (LDN) to be an effective pain reliever for interstitial cystitis, Ehlers-Danlos syndrome, fibromyalgia, and other painful conditions.

LDN advocates believe the drug modulates the immune system, reduces inflammation and stimulates the production of endorphins, the body's natural painkiller. Because it is an opioid antagonist, naltrexone should not be taken with opioid medication.

So far, the shortage only affects 50mg naltrexone tablets. Pain patients usually obtain LDN by prescription from compounding pharmacies, which make the low dose versions in-house.

Several drug makers are reporting short supplies of 50mg tablets, including Accord Healthcare, Major, Elite Laboratories, SpecGx, Sun Pharma, Tagi Pharma, and Avet Pharmaceuticals. The companies didn’t provide the ASHP with a reason for the shortage, but said the tablets are on back order and would be released when they become available.    

The naltrexone shortage comes at an inopportune time, as more people abused alcohol and other substances during the pandemic and sought treatment. The drug that helps them stay sober is now hard to get.

"People are coming in with more cravings," Dr. Aviva Zohar, an addiction medicine provider, told Philly Voice. "Even the feeling of, 'I don't know when my medicine is coming in,' is a huge struggle. It's horrific (and) causing a lot of stress.”

To make up for the shortage, some providers are giving patients Vivitrol, an injectable, extended-release formulation of naltrexone taken once a month. A single Vivitrol injection costs about $1,700, while a month’s supply of 50mg naltrexone tablets costs about $48.

The cheap price of naltrexone may be responsible for the shortage. Most drugs in short supply are low-cost generics with slim profit margins. Some manufacturers have reduced or stopped making generics because they’re not worth the cost of production or the risk of litigation.   

Three generic opioids commonly taken for pain — immediate-release oxycodone, oxycodone-acetaminophen, and hydrocodone-acetaminophen tablets — have been on the ASHP shortage list for nearly a year, with no end in sight.

Prescription Opioids Play Only Minor Role in Overdose Crisis

By Pat Anson, PNN Editor

The role of prescription opioids in the nation’s overdose crisis continues to shrink.

In a new study from the drug testing firm Millennium Health, researchers say multiple substances were found last year in nearly 93% of urine samples in which fentanyl was detected. That is not altogether surprising, as “polysubstance” use increased as fentanyl came to dominate the illicit drug supply, appearing in more and more street drugs such as heroin, cocaine and methamphetamine.

What is surprising is the minimal role that prescription opioids now play. In 2013, opioid pain medication was the most common substance found in fentanyl-positive drug tests in the United States, appearing in over 70% of urine samples.  A decade later, prescription opioids were detected in less than one in ten samples — ranking far behind methamphetamine, cannabis, cocaine and heroin.

In fact, you are about twice as likely to find two other medications -- benzodiazepines (15.8%) and gabapentin (13.3%) -- than you are prescription opioids (7.6%) in urine samples testing positive for fentanyl.

Substances Detected in Fentanyl-Positive Drug Tests (2023)

MILLEnNIUM HEALTH

Millennium based its findings on over 4.1 million urine drug tests (UDTs) collected from 2013 to 2023 and analyzed through mass spectrometry. Because many of those samples came from people being treated for a substance use disorder, they offer a clear insight into drug trends that are driving the overdose crisis.

Now in its “fourth wave,” Millennium says a tidal shift has occurred in the so-called opioid epidemic, with illicit drug users far more likely to use non-opioid substances like stimulants than prescription opioids.

“National, regional, and state-level UDT data all suggest that people who use fentanyl are now, intentionally or unintentionally, much more likely to also use methamphetamine and cocaine,” the report found. “The results of our analyses also reveal shifting patterns of opioid use among those who use fentanyl. More specifically, they showed progressive declines in prescription opioid use from 2015 to 2023.”

The declining role of prescription opioids can be traced back to the 2016 CDC opioid guideline and a multiyear campaign by the DEA to slash opioid production quotas, which has reduced the supply of oxycodone and hydrocodone by about two-thirds. There is little evidence either of those federal efforts reduced the number of overdoses. The CDC estimates there were over 111,000 drug deaths in the 12-month period ending in September 2023 — nearly double the number of fatal overdoses in 2016.

The growing use of stimulants such as methamphetamine makes it difficult for public health campaigns to address the problem. Unlike opioids, there are no FDA-approved medications for stimulant use disorder, leaving behavioral therapies and abstinence as the only “evidence-based” treatments for people with a stimulant problem.

“Stimulants are a serious national challenge emphasizing the need for continued progress on the national plan to address methamphetamine supply, use, and consequences,” Millennium said.

‘Safe Supply’ of Rx Opioids Saved Lives in British Columbia

By Pat Anson, PNN Editor

Prescribing opioids and other medications to people with substance use disorders significantly reduces their risk of dying, according to a large new study in British Columbia. The findings add weight to efforts to create a “safe supply” of legal medications for patients at risk of an overdose from increasingly toxic street drugs.

Vancouver, British Columbia was the first major North American city to be hit by a wave of overdoses involving illicit fentanyl, a potent synthetic opioid. That led Vancouver to become a laboratory for harm reduction programs and safe supply sites offering prescription opioids and injectable heroin to drug users.  

How effective have those programs been?

A study by the B.C. Centre for Disease Control, recently published in the British Medical Journal, found that prescribing opioids, stimulants and anti-anxiety medication to nearly 6,000 drug users dramatically reduced their risk of death.

The Risk Mitigation Guide (RMG) program was initially launched in early 2020 to help drug users going through withdrawal while isolated by the COVID-19 quarantine. A year later, the program was extended, allowing doctors and nurse practitioners to prescribe hydromorphone, morphine, oxycodone, fentanyl, benzodiazepines and stimulants to drug users.

People who were given an initial dose of prescription opioids had a 61% lower risk of death from any cause the following week, and were 55% less likely to die of a drug overdose.

The protective effect of a safe supply increased as more doses were provided. Drug users who received four or more days of opioids were 91% less likely to die from any cause and 89% less likely to die from an overdose.

"We saw a profound impact on reduction in somebody's overdose death risk the week after they picked up these drugs, to a degree that is really surprising and has enormous potential," co-author Paxton Bach, MD, an addiction medicine specialist, told CBC News. "This paper is the strongest evidence we have so far, by a large margin, supporting the idea that this can be an effective strategy for reducing overdose death risk."

But critics of safe supply programs say they don’t really reduce drug abuse. An investigation last year by the National Post found that hydromorphone pills given to drug users in Vancouver were being sold to other addicts, with the sellers then using the money to buy more potent street drugs that were often laced with fentanyl.

A new study in JAMA Internal Medicine also found that opioid-related hospitalizations rose sharply in British Columbia after safe supply programs were launched there, although there was no significant change in overdose deaths. The spike in hospitalizations may have been due to more potent street drugs and counterfeit pills on the black market.

Since a public health emergency was declared in British Columbia in 2016, over 13,000 people have died from drug overdoses. A 2020 analysis found that only about 2% of the B.C. opioid-related deaths were caused by prescription opioids alone. The other overdoses mainly involved illicit fentanyl and other street drugs.  

FDA Approves Genetic Test for Opioid Addiction Risk

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved a controversial genetic test that uses a patient’s DNA to assess whether they are at risk of developing opioid use disorder (OUD).  

Although the test is only intended for patients with short-term acute pain who have not used opioids before, there is concern about the test’s accuracy and whether it will be used “off-label” to assess addiction risk in chronic pain patients – who could potentially lose access to opioids as a result.

In approving the AvertD test, the FDA stipulated that it only be available by prescription to patients who consent to its use and have no prior history of using an oral opioid for pain relief.

The test is administered by a provider swabbing the cheek of a patient to collect a DNA sample, which will then be tested in a laboratory to see if the patient has 15 genetic markers that puts them at elevated risk of OUD.

According to the FDA, the test will help patients “make better informed decisions” about opioids, such as a patient facing surgery who wants to know what analgesic to use for acute post-operative pain.

AUTOGENOMICS IMAGE

"AvertD may help patients who are concerned about being treated with an opioid for acute pain,” Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in a statement. “The test is not intended to be used in patients being treated for chronic pain.”

But given the history of opioid guidelines being mistakenly applied to all kinds of patients, regardless of their condition, some worry the test will be misused.

“I’m sure it would be used for anyone who may be considered for opioid therapy,” says Lynn Webster, MD, a pain management expert and Senior Fellow at the Center for U.S. Policy. “I am all for gathering more data to help clinicians make better decisions, but we must exercise caution with such tests. Otherwise, the test may be over-read or misinterpreted. Some patients may be deprived of access to an opioid if they test positive or there can be a false sense of harmlessness from opioids if the test is negative. 

“I am most concerned that providers will see the results as binary. Either a patient will or won’t develop OUD, depending on the result. That would be a big mistake. Any such device or test must be used along with other clinical and personal information to help mitigate harm from using, or being denied, opioids.”

80% Accuracy

As part of its approval order, the FDA is requiring AutoGenomics – the company that makes AvertD – to provide training to healthcare providers on the proper use of the test and to conduct a post-market study of its performance and accuracy.

In 2022, an FDA advisory committee voted 11-2 against recommending an earlier version of AvertD, primarily because of concerns about false-negative and false-positive results. An observational study found the test was about 80% accurate in detecting genes associated with OUD.

"I believe 100% of the risk associated with this test is with false positives and false negatives -- both people being untreated or poorly treated because somehow it came back as a positive result, or being given inappropriate treatment because it said negative," said Timothy Ness, MD, an anesthesiologist and Professor Emeritus at the University of Alabama at Birmingham, an advisory panel member who voted no.

After the advisory committee vote, the FDA worked with AutoGenomics to modify the test and improve its accuracy. The company then submitted a premarket approval application for the modified test, which the FDA granted without going back to the advisory committee for further review.

“The FDA recognizes that in premarket decision-making for devices, there generally exists some uncertainty around benefits and risks. Given the totality of available evidence and the urgent need for medical devices that can make a positive impact on the overdose crisis, and specifically devices that can help assess the risk of developing OUD, the FDA determined that there is a reasonable assurance of AvertD's safety and effectiveness,” said Dr. Shuren.

But no test is foolproof in either its accuracy or implementation, as Dr. Webster learned when he developed a questionnaire that assesses addiction risk by asking patients about their family history and other potential risk factors. Webster was disappointed to learn his questionnaire was “weaponized” by some providers to deny opioid therapy to patients, particularly women with a history being sexually abused.

Webster says the risk of OUD can’t be measured by a genetic test alone.

“We should not think it is a diagnostic tool or a crystal ball. Having an increased risk due to genetics does not mean that, if exposed to an opioid, an individual necessarily will develop an opioid addiction,” Webster told PNN. 

“We have known for a long time that about fifty percent of the risk of developing an opioid addiction is due to genetics. The other fifty percent is due to environmental factors and life’s experience. Furthermore, people can develop OUD without genetic risks. OUD risk is dynamic, meaning it changes over time with adverse events in life and often co-morbid conditions. For example, there was a surge in all forms of drug abuse, including OUD, during the pandemic because of isolation and loneliness. This is not detected by a genetic test.”

Although the risk of a surgery patient misusing opioids or becoming addicted is low – less than one percent -- the parent company of AutoGenomics has a more stark assessment, calling surgery “a gateway to addiction” that puts another 7 million Americans at risk every year.