Stimulants Involved in Growing Number of Fentanyl Overdoses

By Pat Anson, PNN Editor

The number of drug deaths involving both fentanyl and stimulants has soared in recent years, according to a new UCLA study that highlights the complex and changing nature of the U.S. overdose crisis.

Stimulants such as cocaine and methamphetamine are now involved in nearly a third of fentanyl-related overdoses, the most of any other drug class. Fentanyl is a synthetic opioid up to 100 times more potent than morphine and 50 times as potent as heroin.

In 2010, researchers say there were only 235 fatal overdoses in the U.S. involving illicit fentanyl and stimulants. In 2021, there were 34,429 drug deaths linked to fentanyl and stimulants, a 14,550% increase in a little over a decade.

"We're now seeing that the use of fentanyl together with stimulants is rapidly becoming the dominant force in the US overdose crisis," said lead author Joseph Friedman, PhD, an addiction researcher at the David Geffen School of Medicine at UCLA. "Fentanyl has ushered in a polysubstance overdose crisis, meaning that people are mixing fentanyl with other drugs, like stimulants, but also countless other synthetic substances. This poses many health risks and new challenges for health care providers.

“We have data and medical expertise about treating opioid use disorders, but comparatively little experience with the combination of opioids and stimulants together, or opioids mixed with other drugs. This makes it hard to stabilize people medically who are withdrawing from polysubstance use."

People who overdose on stimulants and other non-opioid substances mixed with fentanyl may not be as responsive to naloxone, which only works as an antidote to opioids.

The study findings, published in the journal Addiction, highlight the four “waves” of the overdose crisis, which began with an increase in deaths from prescription opioids (Wave 1) in the early 2000s, followed by a rise in heroin deaths (Wave 2) in 2010, and fentanyl-related overdoses in 2013 (Wave 3). The fourth wave — overdoses from fentanyl and stimulants — began in 2015 and continues to escalate.

The Four Waves of Overdose Crisis

SOURCE: ADDICTION

Since cocaine, methamphetamine and other stimulants are not opioids, the findings undercut the long-held theory that the overdose crisis started with prescription opioids and is still being fueled by people addicted to them. Deaths involving prescription opioids and heroin have been in decline for several years.

Researchers found that fentanyl/stimulant deaths disproportionately affect African Americans and Native Americans. There are also geographical patterns to fentanyl/stimulant use. In the northeast US, fentanyl is usually combined with cocaine, while in the south and western US, fentanyl is most commonly found with methamphetamine.

"We suspect this pattern reflects the rising availability of, and preference for, low-cost, high-purity methamphetamine throughout the US, and the fact that the Northeast has a well-entrenched pattern of illicit cocaine use that has so far resisted the complete takeover by methamphetamine seen elsewhere in the country," Friedman said.

In addition to its low cost, drug users say methamphetamine helps prolong fentanyl’s “high” and delays the onset of withdrawal symptoms.  

Counterfeit pills laced with fentanyl – which are frequently made to look like oxycodone or alprazolam (Xanax) – represent about a quarter of all illicit fentanyl seizures. Researchers say it is difficult to track deaths involving counterfeit pills because they are often mistaken for legitimate medication, so the data is not completely reliable.

In its most recent update on the overdose crisis, the CDC estimates there were a record 111,355 drug deaths in the 12-month period ending April 2023 -- about a thousand more deaths than the year before. Fentanyl and its analogues were involved in nearly 70% of the overdoses, stimulants were linked to about a third of them, and cocaine was involved in about a quarter of the drug deaths.

CDC Recommends New Covid Boosters

By Arthur Allen, KFF Health News

Everyone over the age of 6 months should get the latest covid-19 booster, a federal expert panel recommended Tuesday after hearing an estimate that universal vaccination could prevent 100,000 more hospitalizations each year than if only the elderly were vaccinated.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted 13-1 for the motion after months of debate about whether to limit its recommendation to high-risk groups. A day earlier, the FDA approved the new booster, stating it was safe and effective at protecting against the covid variants currently circulating in the U.S.

After the last booster was released, in 2022, only 17% of the U.S. population got it — compared with the roughly half of the nation who got the first booster after it became available in fall 2021. Broader uptake was hurt by pandemic weariness and evidence the shots don’t always prevent covid infections. But those who did get the shot were far less likely to get very sick or die, according to data presented at Tuesday’s meeting.

The virus sometimes causes severe illness even in those without underlying conditions, causing more deaths in children than other vaccine-preventable diseases, as chickenpox did before vaccines against those pathogens were universally recommended.

The number of hospitalized patients with covid has ticked up modestly in recent weeks, CDC data shows, and infectious disease experts anticipate a surge in the late fall and winter.

The shots are made by Moderna and by Pfizer and its German partner, BioNTech, which have decided to charge up to $130 a shot. They have launched national marketing campaigns to encourage vaccination. The advisory committee deferred a decision on a third booster, produced by Novavax, because the FDA hasn’t yet approved it. Here’s what to know:

Who Should Get a Booster Shot?

The CDC advises that everyone over 6 months old should, for the broader benefit of all. Those at highest risk of serious disease include babies and toddlers, the elderly, pregnant women, and people with chronic health conditions including obesity. The risks are lower — though not zero — for everyone else. The vaccines, we’ve learned, tend to prevent infection in most people for only a few months. But they do a good job of preventing hospitalization and death, and by at least diminishing infections they may slow spread of the disease to the vulnerable, whose immune systems may be too weak to generate a good response to the vaccine.

Pablo Sánchez, a pediatrics professor at The Ohio State University who was the lone dissenter on the CDC panel, said he was worried the boosters hadn’t been tested enough, especially in kids. The vaccine strain in the new boosters was approved only in June, so nearly all the tests were done in mice or monkeys. However, nearly identical vaccines have been given safely to billions of people worldwide.

When Should You Get It?

The vaccine makers say they’ll begin rolling out the vaccine this week. If you’re in a high-risk group and haven’t been vaccinated or been sick with covid in the past two months, you could get it right away, says John Moore, an immunology expert at Weill Cornell Medical College. If you plan to travel this holiday season, as he does, Moore said, it would make sense to push your shot to late October or early November, to maximize the period in which protection induced by the vaccine is still high.

Who Pays For It?

When the ACIP recommends a vaccine for children, the government is legally obligated to guarantee kids free coverage, and the same holds for commercial insurance coverage of adult vaccines.

For the 25 to 30 million uninsured adults, the federal government created the Bridge Access Program. It will pay for rural and community health centers, as well as Walgreens, CVS, and some independent pharmacies, to provide covid shots for free. Manufacturers have agreed to donate some of the doses, CDC officials said.

Will New Booster Work Against Current Variants?

It should. More than 90% of currently circulating strains are closely related to the variant selected for the booster earlier this year, and studies showed the vaccines produced ample antibodies against most of them. The shots also appeared to produce a good immune response against a divergent strain that initially worried people, called BA.2.86. That strain represents fewer than 1% of cases currently. Moore calls it a “nothingburger.”

Why Are People Still Skeptical About Vaccines?

Experience with the covid vaccines has shown that their protection against hospitalization and death lasts longer than their protection against illness, which wanes relatively quickly, and this has created widespread skepticism.

Most people in the U.S. have been ill with covid and most have been vaccinated at least once, which together are generally enough to prevent grave illness, if not infection — in most people. Many doctors think the focus should be on vaccinating those truly at risk.

What About Getting Other Vaccines?

People tend to get sick in the late fall because they’re inside more and may be traveling and gathering in large family groups. This fall, for the first time, there’s a vaccine — for older adults — against respiratory syncytial virus. Kathryn Edwards, a 75-year-old Vanderbilt University pediatrician, plans to get all three shots but “probably won’t get them all together,” she said.

Covid “can have a punch” and some of the RSV vaccines and the flu shot that’s recommended for people 65 and older also can cause sore arms and, sometimes, fever or other symptoms. A hint emerged from data earlier this year that people who got flu and covid shots together might be at slightly higher risk of stroke. That linkage seems to have faded after further study, but it still might be safer not to get them together.

Pfizer and Moderna are both testing combination vaccines, with the first flu-covid shot to be available as early as next year. Although Pfizer’s shot has been approved in the European Union, Japan, and South Korea, and Moderna has won approval in Japan and Canada. Rollouts will start in the U.S. and other countries this week.

Unlike in earlier periods of the pandemic, mandates for the booster are unlikely. But “it’s important for people to have access to the vaccine if they want it,” said panel member Beth Bell, a professor of public health at the University of Washington.

“Having said that, it’s clear the risk is not equal, and the messaging needs to clarify that a lot of older people and people with underlying conditions are dying, and they really need to get a booster,” she said.

ACIP member Sarah Long, a pediatrician at Children’s Hospital of Philadelphia, voted for a universal recommendation but said she worried it was not enough. “I think we’ll recommend it and nobody will get it,” she said. “The people who need it most won’t get it.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

ChatGPT Is Replacing Dr. Google

By Andrew Leonard, KFF Health News

As a fourth-year ophthalmology resident at Emory University School of Medicine, Riley Lyons’ biggest responsibilities include triage: When a patient comes in with an eye-related complaint, Lyons must make an immediate assessment of its urgency.

He often finds patients have already turned to “Dr. Google.” Online, Lyons said, they are likely to find that “any number of terrible things could be going on based on the symptoms that they’re experiencing.”

So, when two of Lyons’ fellow ophthalmologists at Emory came to him and suggested evaluating the accuracy of the AI chatbot ChatGPT in diagnosing eye-related complaints, he jumped at the chance.

In June, Lyons and his colleagues reported in medRxiv, an online publisher of health science preprints, that ChatGPT compared quite well to human doctors who reviewed the same symptoms — and performed vastly better than the symptom checker on the popular health website WebMD.

And despite the much-publicized “hallucination” problem known to afflict ChatGPT — its habit of occasionally making outright false statements — the Emory study reported that the most recent version of ChatGPT made zero “grossly inaccurate” statements when presented with a standard set of eye complaints.

The relative proficiency of ChatGPT, which debuted in November 2022, was a surprise to Lyons and his co-authors. The artificial intelligence engine “is definitely an improvement over just putting something into a Google search bar and seeing what you find,” said co-author Nieraj Jain, an assistant professor at the Emory Eye Center who specializes in vitreoretinal surgery and disease.

But the findings underscore a challenge facing the health care industry as it assesses the promise and pitfalls of generative AI, the type of artificial intelligence used by ChatGPT: The accuracy of chatbot-delivered medical information may represent an improvement over Dr. Google, but there are still many questions about how to integrate this new technology into health care systems with the same safeguards historically applied to the introduction of new drugs or medical devices.

The smooth syntax, authoritative tone, and dexterity of generative AI have drawn extraordinary attention from all sectors of society, with some comparing its future impact to that of the internet itself. In health care, companies are working feverishly to implement generative AI in areas such as radiology and medical records.

When it comes to consumer chatbots, though, there is still caution, even though the technology is already widely available — and better than many alternatives. Many doctors believe AI-based medical tools should undergo an approval process similar to the FDA’s regime for drugs, but that would be years away. It’s unclear how such a regime might apply to general-purpose AIs like ChatGPT.

“There’s no question we have issues with access to care, and whether or not it is a good idea to deploy ChatGPT to cover the holes or fill the gaps in access, it’s going to happen and it’s happening already,” said Jain. “People have already discovered its utility. So, we need to understand the potential advantages and the pitfalls.”

The Emory study is not alone in ratifying the relative accuracy of the new generation of AI chatbots. A report published in Nature in early July by a group led by Google computer scientists said answers generated by Med-PaLM, an AI chatbot the company built specifically for medical use, “compare favorably with answers given by clinicians.”

AI may also have better bedside manner. Another study, published in April by researchers from the University of California-San Diego and other institutions, even noted that health care professionals rated ChatGPT answers as more empathetic than responses from human doctors.

Indeed, a number of companies are exploring how chatbots could be used for mental health therapy, and some investors in the companies are betting that healthy people might also enjoy chatting and even bonding with an AI “friend.” The company behind Replika, one of the most advanced of that genre, markets its chatbot as, “The AI companion who cares. Always here to listen and talk. Always on your side.”

“We need physicians to start realizing that these new tools are here to stay and they’re offering new capabilities both to physicians and patients,” said James Benoit, an AI consultant. While a postdoctoral fellow in nursing at the University of Alberta in Canada, he published a study in February reporting that ChatGPT significantly outperformed online symptom checkers in evaluating a set of medical scenarios. “They are accurate enough at this point to start meriting some consideration,” he said.

A ’Band-Aid’ Solution

Still, even the researchers who have demonstrated ChatGPT’s relative reliability are cautious about recommending that patients put their full trust in the current state of AI. For many medical professionals, AI chatbots are an invitation to trouble: They cite a host of issues relating to privacy, safety, bias, liability, transparency, and the current absence of regulatory oversight.

The proposition that AI should be embraced because it represents a marginal improvement over Dr. Google is unconvincing, these critics say.

“That’s a little bit of a disappointing bar to set, isn’t it?” said Mason Marks, a professor and MD who specializes in health law at Florida State University. He recently wrote an opinion piece on AI chatbots and privacy in the Journal of the American Medical Association.

“I don’t know how helpful it is to say, ‘Well, let’s just throw this conversational AI on as a band-aid to make up for these deeper systemic issues,’” he said to KFF Health News.

The biggest danger, in his view, is the likelihood that market incentives will result in AI interfaces designed to steer patients to particular drugs or medical services. “Companies might want to push a particular product over another,” said Marks. “The potential for exploitation of people and the commercialization of data is unprecedented.”

OpenAI, the company that developed ChatGPT, also urged caution.

“OpenAI’s models are not fine-tuned to provide medical information,” a company spokesperson said. “You should never use our models to provide diagnostic or treatment services for serious medical conditions.”

John Ayers, a computational epidemiologist who was the lead author of the UCSD study, said that as with other medical interventions, the focus should be on patient outcomes.

“If regulators came out and said that if you want to provide patient services using a chatbot, you have to demonstrate that chatbots improve patient outcomes, then randomized controlled trials would be registered tomorrow for a host of outcomes,” Ayers said.

He would like to see a more urgent stance from regulators.

“One hundred million people have ChatGPT on their phone,” said Ayers, “and are asking questions right now. People are going to use chatbots with or without us.”

At present, though, there are few signs that rigorous testing of AIs for safety and effectiveness is imminent. In May, Robert Califf, the commissioner of the FDA, described “the regulation of large language models as critical to our future,” but aside from recommending that regulators be “nimble” in their approach, he offered few details.

In the meantime, the race is on. In July, The Wall Street Journal reported that the Mayo Clinic was partnering with Google to integrate the Med-PaLM 2 chatbot into its system. In June, WebMD announced it was partnering with a Pasadena, California-based startup, HIA Technologies Inc., to provide interactive “digital health assistants.” And the ongoing integration of AI into both Microsoft’s Bing and Google Search suggests that Dr. Google is already well on its way to being replaced by Dr. Chatbot.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

The National Opioid Settlement Is Causing Drug Shortages

By Pat Irving, Guest Columnist

I am a retired nurse with over 40 years of healthcare experience. The principal focus of my career was on healthcare regulations, risk management and patient safety.  My most recent position was as National Leader for Risk and Patient Safety for Kaiser Permanente. 

As a pain patient myself and the victim of a mandatory opioid taper, I was motivated to understand the reasons behind the many difficulties patients have getting opioids, anti-anxiety medications and other controlled substances. 

The goal of my research over the last several months is to help patients and their families understand the drastic changes in pain management that have occurred in recent years. While much of it is due to the CDC opioid guideline and the law enforcement crackdown on prescribers, the fallout from opioid litigation now plays a major role in our inability to get prescriptions filled.

As early as 2017, acting on the incorrect premise that prescription opioids were the primary cause for the opioid crisis, the National Association of Attorneys General began a legal assault on entities they believed were responsible for the “opioid crisis.”  This included opioid manufacturers, big chain pharmacies, and the three biggest wholesale distributors -- AmerisourceBergen, Cardinal Health, and McKesson.

On July 21, 2021, the Attorneys General announced that they had reached a $26 billion settlement with the three distributors and Johnson & Johnson, who agreed to make major changes in how they do business.  The intent was to improve the safety and oversight of prescription opioids, but the unintended consequences of the settlement have caused incalculable harm to patients with chronic pain and mental health disorders.

In addition to the monetary settlement, the three distributors agreed to substantially increase measures to identity suspicious orders from pharmacies for ten years.  The distributors, collectively known as “Injunctive Relief Distributors,” also established an independent clearinghouse to keep track of every shipment of opioids and other controlled substances to pharmacies.

Red Flags and Suspicious Orders

For reference, the 571-page settlement can be found at this link.  The most important section (Exhibit “P”) begins on page 478.  Among other things, it requires the distributors to collect from each pharmacy a list of their top prescribers for opioids and other “Highly Diverted Controlled Substances,” the number of prescriptions and doses they wrote, their DEA registration number, address and medical specialty.

You may notice several other things.  Many of the restrictions came directly out of DEA regulations.  For example, there is language about “Red Flags” and “Suspicious Orders,” the latter being “orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.”

Other potential red flags include patients paying for a prescription in cash and “out-of-area” patients with prescribing doctors from a zip code that’s 50 miles or more from the pharmacy. 

If a pharmacy customer has an excessive number of suspicious orders or “unresolved Red Flag activity,” it risks being “terminated” from receiving further controlled substances – which would effectively put the pharmacy out of business: 

“In the event that an Injunctive Relief Distributor identifies one or more unresolved Red Flags or other information indicative of potential diversion of Controlled Substances through the onboarding process or otherwise, the Injunctive Relief Distributor shall refrain from selling Controlled Substances to the potential Customer pending additional due diligence.”

It is easy to see why the settlement has made pharmacists more hesitant, even fearful, about filling orders that might be suspicious. 

Under federal law, pharmacists already had a “corresponding authority” to decide whether a prescription is suspicious and if it should be filled. Whereas before a pharmacist might call a prescriber to double check on a prescription and the reasons for it, under the settlement a pharmacist may err on the side of caution and not fill the prescription at all.

To make the situation worse, the definitions of “suspicious orders” are purposely vague, and may be interpreted in the strictest way possible.  For example, since the CDC guideline recommends that physicians “should carefully evaluate” increasing doses above 50 morphine milligram equivalents (MME), the distributor or pharmacy may see that as hard limit, not a suggestion.  

And because the CDC guideline urges caution when prescribing opioids and benzodiazepines together, that may be another hard stop on a prescription, regardless of how long or how safely a patient was managed on these medications. There may be serious consequences for the prescribing physician as well, who could be reported to state authorities and the DEA if they have too many suspicious prescriptions.

Medication Thresholds 

The injunction also brought with it medication “thresholds.”  Unlike the annual DEA production quotas which are imposed on drug makers nationwide, the settlement thresholds are very specific to each pharmacy or pharmacy chain. It limits the total volume of a controlled substance that a pharmacy may receive in any given month, quarter and year.  These threshold limits, are developed by the distributor using a statistical algorithm of their own design. 

Once a pharmacy has exceeded its particular threshold, it is unable to obtain additional medication in that drug category. Physicians and patients have no way of knowing if they are the unlucky ones to have exceeded a pharmacy’s threshold.  For many patients, this means being cutoff cold turkey, waiting another month, or having a prescription only partially filled – essentially a forced taper.

Many health plans talk about their concern for patient safety, but there is often a lack of information given to patients about the known risks of tapering, especially for “legacy” patients who have been on prescribed opioids for an extended period, and who were stable and doing well. There is often no discussion with the tapered patient on the possibility of withdrawal, suicidal thoughts, anxiety, depression, and unmanaged pain. 

The patient population most affected by the distributors’ settlement are either disabled, seniors or both.  This is the very population that has difficulty accessing alternative pain therapies such as acupuncture or injections, and in many cases are alone and homebound. It has been almost impossible to get attention for this segment of the population that needs the most support. 

There has been no strong response to the settlement and resulting drug shortages from the Health and Human Services Administration, DEA, CDC, or FDA.  There has also been a lack of a coordinated response from Medicare/CMS to patients being forcibly tapered. 

It is likewise unclear what position state medical and pharmacy boards are taking on the ruptured drug supply chain. Many patients with legitimate prescriptions now have to wait weeks for their medications to become available or are forced to travel to other pharmacies to get their prescriptions filled. Worst of all, the suffering imposed on these patients has done nothing to reduce the number of drug overdose deaths.

Our government must wake up to the fact that the injunction portion of the settlement must be modified.  There are sections of the settlement that allow for “potential adjustments” and “modifications” in the event of a national or state emergency “to meet the critical needs of the supply chain.” Such an emergency now exists.

Future efforts by stakeholders must focus attention on these sections and the need for changes. It is possible to have a safe and well monitored drug supply chain that also allows legitimate patients to have the medical treatment they deserve. As it stands now, patients are needlessly suffering due to the unreasonable restrictions imposed by the national opioid settlement.

Pat Irving, RN, lives with Complex Regional Pain Syndrome (now in remission) and piriformis syndrome, a type of sciatica. Pat wishes to thank Monty Goddard, a patient advocate, for his contributions to her research.

Shrinking Number of Primary Care Doctors Reaches Tipping Point

By Elisabeth Rosenthal, KFF Health News

I’ve been receiving an escalating stream of panicked emails from people telling me their longtime physician was retiring, was no longer taking their insurance, or had gone concierge and would no longer see them unless they ponied up a hefty annual fee.

They have said they couldn’t find another primary care doctor who could take them on or who offered a new-patient appointment sooner than months away.

Their individual stories reflect a larger reality: American physicians have been abandoning traditional primary care practice — internal and family medicine — in large numbers. Those who remain are working fewer hours. And fewer medical students are choosing a field that once attracted some of the best and brightest because of its diagnostic challenges and the emotional gratification of deep relationships with patients.

The percentage of U.S. doctors in adult primary care has been declining for years and is now about 25% — a tipping point beyond which many Americans won’t be able to find a family doctor at all.

Already, more than 100 million Americans don’t have usual access to primary care, a number that has nearly doubled since 2014. One reason our coronavirus vaccination rates were low compared with those in countries such as China, France, and Japan could be because so many of us no longer regularly see a familiar doctor we trust.

Another telling statistic: In 1980, 62% of doctor’s visits for adults 65 and older were for primary care and 38% were for specialists, according to Michael L. Barnett, a health systems researcher and primary care doctor in the Harvard Medical School system.

By 2013, that ratio had exactly flipped and has likely “only gotten worse,” Barnett said, noting sadly: “We have a specialty-driven system. Primary care is seen as a thankless, undesirable backwater.” That’s “tragic,” in his words — studies show that a strong foundation of primary care yields better health outcomes overall, greater equity in health care access, and lower per capita health costs.

Practices Sold

One explanation for the disappearing primary care doctor is financial. The payment structure in the U.S. health system has long rewarded surgeries and procedures while shortchanging the diagnostic, prescriptive, and preventive work that is the province of primary care. Furthermore, the traditionally independent doctors in this field have little power to negotiate sustainable payments with the mammoth insurers in the U.S. market.

Faced with this situation, many independent primary care doctors have sold their practices to health systems or commercial management chains (some private equity-owned) so that, today, three-quarters of doctors are now employees of those outfits.

One of them was Bob Morrow, who practiced for decades in the Bronx. For a typical visit, he was most recently paid about $80 if the patient had Medicare, with its fixed-fee schedule. Commercial insurers paid significantly less. He just wasn’t making enough to pay the bills, which included salaries of three employees, including a nurse practitioner.

“I tried not to pay too much attention to money for four or five years — to keep my eye on my patients and not the bottom line,” he said by phone from his former office, as workers carted away old charts for shredding.

Morrow finally gave up and sold his practice last year to a company that took over scheduling, billing, and negotiations with insurers. It agreed to pay him a salary and to provide support staff as well as supplies and equipment.

The outcome: Calls to his office were routed to a call center overseas, and patients with questions or complaining of symptoms were often directed to a nearby urgent care center owned by the company — which is typically more expensive than an office visit. His office staff was replaced by a skeleton crew that didn’t include a nurse or skilled worker to take blood pressure or handle requests for prescription refills. He was booked with patients every eight to 10 minutes.

He discovered that the company was calling some patients and recommending expensive tests — such as vascular studies or an abdominal ultrasound — that he did not believe they needed.

He retired in January. “I couldn’t stand it,” he said. “It wasn’t how I was taught to practice.”

‘Squeezed From All Sides’

Of course, not every practice sale ends with such unhappy results, and some work out well. But the dispirited feeling that drives doctors away from primary care has to do with far more than money. It’s a lack of respect for nonspecialists. It’s the rising pressure to see and bill more patients: Employed doctors often coordinate the care of as many as 2,000 people, many of whom have multiple problems.

And it’s the lack of assistance. Profitable centers such as orthopedic and gastroenterology clinics usually have a phalanx of support staff. Primary care clinics run close to the bone.

“You are squeezed from all sides,” said Barnett.

Many ventures are rushing in to fill the primary care gap. There had been hope that nurse practitioners and physician assistants might help fill some holes, but data shows that they, too, increasingly favor specialty practice. Meanwhile, urgent care clinics are popping up like mushrooms. So are primary care chains such as One Medical, now owned by Amazon. Dollar General, Walmart, Target, CVS Health, and Walgreens have opened “retail clinics” in their stores.

Rapid-fire visits with a rotating cast of doctors, nurses, or physician assistants might be fine for a sprained ankle or strep throat. But they will not replace a physician who tells you to get preventive tests and keeps tabs on your blood pressure and cholesterol — the doctor who knows your health history and has the time to figure out whether the pain in your shoulder is from your basketball game, an aneurysm, or a clogged artery in your heart.

Some relatively simple solutions are available, if we care enough about supporting this foundational part of a good medical system. Hospitals and commercial groups could invest some of the money they earn by replacing hips and knees to support primary care staffing; giving these doctors more face time with their patients would be good for their customers’ health and loyalty if not (always) the bottom line.

Reimbursement for primary care visits could be increased to reflect their value — perhaps by enacting a national primary care fee schedule, so these doctors won’t have to butt heads with insurers. And policymakers could consider forgiving the medical school debt of doctors who choose primary care as a profession.

They deserve support that allows them to do what they were trained to do: diagnosing, treating, and getting to know their patients.

The United States already ranks last among wealthy countries in certain health outcomes. The average life span in America is decreasing, even as it increases in many other countries. If we fail to address the primary care shortage, our country’s health will be even worse for it.

KFF Health News is a national newsroom that produces in-depth journalism about health issues. 

Chronic Pain Patients Report Improvement from Cannabis Oil

By Pat Anson, PNN Editor

Patients with chronic pain and other illnesses who did not respond to conventional treatment reported improvements in pain, anxiety, depression, fatigue and quality of life after being prescribed cannabis oil for three months, according to a large new Australian study. There were no improvements in patients with insomnia.

Researchers at the University of Sydney surveyed 2,327 patients with chronic health issues who were prescribed cannabis oil products containing cannabinoids, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). The oils are made by Little Green Pharma , a company that specializes in cannabis-based medicine and provided funding for the Quality of Life Evaluation Study (QUEST Initiative).

Over two-thirds of the participants (69%) suffered from chronic pain. Half were being treated for more than one health condition; and one in four were unemployed, on leave, or had limited work duties due to illness.   

Medical cannabis was legalized in Australia in 2016. Cannabis is only available by prescription in Australia to patients with health conditions that are unresponsive to conventional treatment.

“Short-term findings over 3-months indicate that patients prescribed MC (medical cannabis) in practice have improved HRQL (health-related quality of life) and reduced fatigue. Patients experiencing anxiety, depression, or chronic pain also improved in those outcomes over 3-months, but no changes in sleep disturbance were observed in patients with sleep disorders,” researchers reported in PLOS ONE.  

“The study continues to follow patients over 12-months to determine whether improvements in PROs (patient reported outcomes) are maintained long-term. In addition, further subgroup analyses will be undertaken to determine whether patients with specific health conditions have better outcomes compared with others when using validated condition-specific questionnaires.”

The researchers did not measure adverse effects in the QUEST Initiative, but 30 participants withdrew from the study due to “unwanted side effects.” The authors noted that more research on cannabis oil products used in the study is needed in order to successfully treat patients with insomnia and sleep disorders.

Another recent survey in Australia of patients with chronic illness found significant improvements in their physical and mental health after they started using medical cannabis. Most of the cannabis products in that study were oils containing CBD and/or THC.   

'Growing Pains' in Childhood Linked to Migraine

By Pat Anson, PNN Editor

Did you experience “growing pains” as a child? An unusual ache or throbbing in your legs that occurred late in the day and kept you awake at night?

The Mayo Clinic says there’s no evidence that a growth spell actually causes physical pain, and that any discomfort may be caused by a low pain threshold or even psychological issues.

But a small new study suggests something else may be going on: Brazilian researchers say children who have growing pains are significantly more likely to develop migraines – just as their parents did.  Migraine can be hereditary, and if one or both parents have migraine, there’s a 50-75% chance that their children will also.

“In families of children with growing pains, there is an increased prevalence of other pain syndromes, especially migraine among parents,” wrote lead author Raimundo Pereira Silva-Néto. PhD, a neurology professor at Federal University of Delta do Parnaibal. “Children with migraine have a higher prevalence of growing pains, suggesting a common pathogenesis; therefore, we hypothesized that growing pains in children are a precursor or comorbidity with migraine.”

With parental authorization, Silva-Néto and his colleagues followed 78 children between 5 and 10 years of age, who were born to mothers being treated for migraine at a headache clinic. Their findings were published in the journal Headache.

After five years, about half of the children reported growing pains in their lower limbs. Headaches occurred in 76% of those children, with many meeting the criteria for migraine without aura. By comparison, only 22% of the children who did not have growing pains had headaches.

Lower limb pain was reported most often in the calf muscles (70%), usually lasted more than 30 minutes, and occurred more frequently at night.

That nocturnal connection intrigued the researchers, who noted that previous studies have found that sleepwalking, nightmares, and restless leg syndrome also occur more frequently in children who have migraines.   

“There is no definitive explanation for the nocturnal patterns of growing pains, nor for the overlap with sleep disturbances; however, the authors believe the hypothesis of a common pathogenesis with migraine,” researchers concluded. “Pain in the lower limbs of children and adolescents, commonly referred to as GP (growing pains) by pediatricians and orthopedists, may reflect a precursor/comorbidity with migraine.”

Migraine affects about 39 million people in the United States and is the second leading cause of disability worldwide, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound. About one in five teens suffer from migraine.

Rx Opioid Shortages Persist With No Federal Action

By Pat Anson, PNN Editor

There is no end in sight to shortages of opioid pain medication in the US, with the federal government taking no apparent action to increase opioid production and several drug makers unable to estimate when full supplies will be restored.

In a recent update, the American Society of Health-System Pharmacists (ASHP) said five generic drug makers were running low or have exhausted their supply of oxycodone/acetaminophen tablets, which are better known as the brand names Percocet and Endocet. The medication is usually prescribed for moderate to severe pain.   

ASHP asked drug makers about their current supplies and received these responses:

• Camber has no doses of oxycodone/acetaminophen available. The tablets are on back order and “the company cannot estimate a release date.” Camber said it was still awaiting DEA approval for additional supplies.

• Amneal and KVK-Tech said they had limited supplies of 5 and 7.5 mg oxycodone/acetaminophen tablets, and that 10 mg tablets were on back order with no estimated resupply date.

• Major anticipates getting 7.5 mg tablets in late September and 10 mg tablets in late October.

• Rhodes said it had 7.5 and 5 mg tablets on “intermittent back order” and would only be releasing supplies as they become available.

Percocet and Endocet tablets in various doses are still available from Endo and Par Pharmaceuticals, according to the ASHP.

Shortages of oxycodone/acetaminophen tablets, as well as immediate release oxycodone and hydrocodone/acetaminophen tablets, were first reported by ASHP several months ago. But they have yet to appear on the FDA’s drug shortage list or even be publicly acknowledged by the agency.

In a recent joint letter, FDA Commissioner Robert Califf, MD, and DEA administrator Anne Milgram said they were working “as quickly as possible” to resolve persistent drug shortages. But the letter only addressed shortages of prescription stimulants used to treat ADHD, and makes no mention of opioids.

When asked by PNN, one federal health official did acknowledge shortages of opioid medication, but was vague about possible solutions.

“This is an important issue that CDC and other federal partners are aware of and working to find solutions to,” said Stephanie Rubel, who heads the CDC’s Overdose Preparedness and Response Team (ORRP). Rubel’s office works with other federal and state agencies to reduce the serious risks posed to patients who suddenly lose access to prescription opioids. 

“As part of ORRP’s work, we strongly encourage state health officials to proactively partner with pharmacists and pharmacies to ensure that impacted patients are able to continue receiving appropriate pain management care after a disruption,” said Rubel in a statement to PNN. “Because ORRP cannot provide medical care or make referrals to healthcare providers, advanced preparation and partnerships with pharmacists is essential to ensure continuity of care.” 

But many pharmacists have their hands tied due to opioid litigation. Last year, three large drug wholesalers reached a $21 billion settlement with 46 states, requiring them to impose strict limits on the pharmacies they do business with. Most pharmacies are capped on the amount of opioids they can dispense in any given month, regardless of patient needs. An unusually large order for opioids could get a pharmacy red-flagged by its wholesale supplier and the order cancelled.  

Another reason for the shortages are persistent problems in the drug supply chain and the heavy US reliance on foreign suppliers for many drugs, especially low-cost generic ones.  A third factor is aggressive cuts in the opioid supply by the DEA, which sets annual production quotas for controlled substances that drug manufacturers must follow.

Whatever the cause, it’s leaving many patients with uncontrolled pain and little faith in their government.

“I've been on hydrocodone for 10 years. With the shortage that is going on in Las Vegas, I've been out for 4 weeks,” one patient told PNN. “Unfortunately, the pain has made it too difficult to take care of myself. I cannot clean, cook or sleep without my pain levels increasing. I've been living on frozen foods and Alka Seltzer.”

“I live with 200 other seniors in a low-income complex.  I’ve seen three older veteran residents commit suicide because they couldn’t get pain medication.  I know several other seniors who live with horrible pain and are not able to get medication,” another patient told us.

“The US Government is just screwing us over by limiting what the pharmacies can get and what their suppliers can make. This is driving people to buy pain meds off the street and that's like playing Russian roulette,” said another patient who has trouble getting Norco prescriptions filled by his pharmacy. “Our government is supposed to help us, not hurt us.”

Drug makers are required to report shortages and supply interruptions to the FDA, but prescribers, pharmacies and consumers can also report them by email to drugshortages@fda.hhs.gov.  

To report a drug shortage to the ASHP, click here.

Rescheduling Won’t End Conflict Between Federal and State Marijuana Laws

By Paul Armentano, Guest Columnist 

Ten months after the Biden administration requested the Department of Health and Human Services (HHS) “to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law,” Secretary Xavier Becerra confirmed that the agency has recommended cannabis be removed from its Schedule I classification and placed in a lower schedule.

While the explicit details of HHS’ recommendation are not public, Bloomberg reports that the agency seeks to have cannabis moved to the less restrictive Schedule III of the federal Controlled Substances Act. 

The HHS recommendation now goes to the Drug Enforcement Administration, which will conduct its own scientific review. In the past, the DEA has employed its own five-factor test (which differs from HHS’ criteria) to determine whether or not cannabis ought to be rescheduled. On four prior occasions, most recently in 2016, the agency determined that cannabis failed to meet any of its five criteria.  

While it remains unknown at this time how the DEA will ultimately respond to HHS’ request, many are already speculating about the potential implications of such a policy change. And while some entities, particularly those involved in the commercial cannabis industry, have lauded the proposed change as a “giant” step forward, others – like myself – have been far more restrained.

That’s because reclassifying cannabis from Schedule I to Schedule III is neither intellectually honest, nor does it sufficiently address the widening chasm between state and federal marijuana laws. 

Specifically, reclassifying cannabis to a lower schedule within the CSA continues to misrepresent the plant’s safety relative to other controlled substances such as oxycodone and hydrocodone (Schedule II), codeine and ketamine (Schedule III), benzodiazepines (Schedule IV), or alcohol (unscheduled). More importantly, rescheduling marijuana fails to provide states with the explicit legal authority to regulate it within their borders as best they see fit, free from federal interference.  

To date, 38 states regulate the production and distribution of cannabis products for medical purposes. Twenty-three of these states regulate the possession and use of marijuana for adults. All of the state laws are currently in conflict with federal marijuana laws. Rescheduling cannabis to Schedule III will not change this reality. 

That’s because Schedule III substances are regulated only for prescription use by the federal government. That means legal access to these substances is limited to patients who possess a prescription from a licensed physician and who have obtained the product from a licensed pharmacy.

Currently, no state government regulates cannabis in such a manner – nor is it likely that any state will reconstruct their existing laws and regulations to do so in the future. 

Simply put, if marijuana is rescheduled, state laws authorizing citizens to possess cannabis for either medical or social purposes will continue be in violation of the federal law, as would the thousands of state-licensed dispensaries that currently serve these markets. And the DEA would still possess the same authority it has now under federal law to crack down on these state-regulated markets should it elect to do so. 

Some have suggested that rescheduling the cannabis plant may provide greater opportunities for investigators to conduct clinical research into its eventual drug development, but this result is also unlikely. That is because many of the existing hurdles to clinical cannabis research, such as the limits placed upon scientists’ access to source materials, are marijuana-specific regulations and predate cannabis’ Schedule I classification.

Other impediments, such as requiring the US Attorney General to approve marijuana-specific research protocols are statutory and are not specific to marijuana’s scheduling in the CSA. 

For these reasons, the National Organization for the Reform of Marijuana Laws (NORML) holds the position that the only productive outcome of the current scheduling review would be a recommendation to deschedule cannabis – thereby removing it from the Controlled Substances Act altogether and providing states with greater discretion to establish their own distinct marijuana policies. (A case in point: In 2018 Congress removed from the CSA hemp plants containing no more than 0.3 percent THC, as well as certain cannabinoids derived from them.)

Descheduling would remove the threat of undue federal intrusion in existing state marijuana programs and would respect America’s longstanding federalist principles allowing states to serve as “laboratories of democracy.”

By contrast, rescheduling simply perpetuates the existing contradictions between state and federal cannabis laws, and it fails to provide any necessary legal recognition from the federal government to either the state-licensed cannabis industry or those adults who use the plant responsibly in compliance with state laws.

Paul Armentano is the Deputy Director for NORML, the National Organization for the Reform of Marijuana Laws.

CDC Report ‘Likely Underestimated’ Deaths Linked to Counterfeit Drugs

By Pat Anson, PNN Editor

A new report from the Centers for Disease Control and Prevention found that fatal overdoses in the U.S. from counterfeit medication more than doubled in recent years, with 93% of those deaths involving illicit fentanyl.

Deaths from counterfeit pills rose from 2% of all overdoses in the third quarter of 2019 to 4.7% of drug deaths in the last quarter of 2021, according to the CDC’s Morbidity and Mortality Weekly Report (MMWR). The overdose rate from fake medication was three times higher in western U.S. states (14.7%). 

However, due the unreliability of death certificates, witnesses and coroner investigations, as well as other flaws in the study’s methodology, the MMWR report acknowledges that the number of deaths involving counterfeit medication is “likely underestimated.”

CDC researchers only looked at overdose data from 34 states and the District of Columbia, identifying 2,437 deaths linked to counterfeit pills during the 30-month study period.

Nearly 106,700 people in the U.S. died from drug overdoses in 2021, so if the 4.7% death rate was applied to that year alone, that would suggest there were over 5,000 deaths nationwide involving counterfeit medication.

Even that estimate is probably on the low end, because CDC researchers focused on counterfeit pills made to look like oxycodone and the anti-anxiety drug alprazolam (Xanax).

While “Mexican Oxy” – blue tablets that look like 30mg oxycodone – are favored by counterfeiters, fake pills are also designed to look like Vicodin, Norco, Adderall, and many other medications. Deaths from those pills were not counted.  

Importantly, whether a death was even linked to fake medication “depended largely on scene or witness evidence of pill use” and other anecdotal evidence, rather than toxicology tests on the pills or the actual people who died.

And while pills are obviously designed to be taken orally, the MMWR report only includes “noningestion routes of drug use,” such as smoking, snorting or injection, which require the pills to be ground into powder or liquefied. CDC researchers considered data on the oral ingestion of counterfeit pills so unreliable, “that information is not presented” in the report.

Many of these details on the study’s strange methodology are buried in the footnotes of the MMWR report, which a casual reader could easily miss. 

Not surprisingly, given the limitations on data, smoking was found to have an outsized role in overdose deaths. According to the MMWR, nearly 40% of the deaths linked to counterfeit medication involved smoking – a misleading statistic, given the study’s flaws. But that didn’t stop researchers from drawing conclusions or recommending “safer smoking practices.”

“The higher percentage of deaths with evidence of drug use by smoking might reflect recent general shifts from injecting drugs to smoking them in western states or could be specific to counterfeit pill use methods,” wrote lead author Julie O’Donnell, PhD, an epidemiologist at the CDC’s National Center for Injury Prevention and Control.

“Harm reduction services that expand outreach to persons using drugs by methods other than injection, such as smoking, and provide education about safer smoking practices and risks related to smoking, might be most successful at addressing diverse drug use patterns.”

There’s a safer way to smoke illicit fentanyl?

This is the CDC’s first MMWR report to look exclusively at deaths caused by fake pills, a public health crisis that the agency has been slow to acknowledge. The DEA started warning about a “fentanyl crisis” as far back as 2016, a time when the CDC was preoccupied with its guideline to reduce opioid prescribing.

There were major flaws in CDC research even back then. The agency eventually admitted that thousands of overdose deaths linked to illicit fentanyl and other street drugs were misclassified as deaths caused by prescription opioids. Some deaths that involved more than one drug were counted multiple times.

HHS to DEA: Marijuana Is Not Heroin

By Pat Anson, PNN Editor

The top U.S. health agency is asking the Drug Enforcement Administration to reclassify marijuana as a Schedule III drug under the Controlled Substances Act, putting cannabis in the same risk category as codeine, ketamine and steroids. Marijuana is currently classified as a Schedule I substance, the same as heroin and LSD.  

Bloomberg News was first to report that a top administrator in the Department of Health and Human Services (HHS) wrote a letter to DEA Administrator Anne Milgram asking for the change. Although 38 states and the District of Columbia have legalized recreational or medical marijuana, it remains illegal under federal law.

President Biden asked HHS Secretary Xavier Becerra nearly a year ago to review marijuana’s legal status, saying the classification of marijuana on the same level as heroin “makes no sense” and that people shouldn’t go to jail for marijuana possession.

“I can now share that, following the data and science, @HHSGov has responded to @POTUS’ directive to me for the Department to provide a scheduling recommendation for marijuana to the DEA. We’ve worked to ensure that a scientific evaluation be completed and shared expeditiously,” Becerra posted on Twitter Wednesday.

Although the Biden administration favors the move, rescheduling will not be a slam dunk. Marijuana falls under the jurisdiction of the Department of Justice, not HHS, and Milgram reports to Attorney General Merrick Garland, not Becerra. Conservative states where marijuana remains illegal are also likely to oppose the move.

Rescheduling has long been the goal of marijuana advocates, but some are disappointed that HHS is recommending it be moved to Schedule III, where it will still be regulated as a controlled substance.

“The goal of any federal cannabis policy reform ought to be to address the existing, untenable chasm between federal marijuana policy and the cannabis laws of the majority of US states. Rescheduling the cannabis plant to Schedule III of the US Controlled Substances Act fails to adequately address this conflict,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“Just as it is intellectually dishonest to categorize cannabis in the same placement as heroin, it is equally disingenuous to treat cannabis in the same manner as anabolic steroids. The majority of Americans believe that cannabis ought to be legal and that its hazards to health are less significant than those associated with federally descheduled substances like alcohol and tobacco. Like those latter substances, we have long argued the cannabis plant should be removed from the Controlled Substances Act altogether.”

The DEA will now conduct its own scientific review of marijuana. On at least four previous occasions, the DEA has refused to reschedule marijuana because there were inadequate safety studies and little scientific evidence supporting its use.

Another major hurdle under federal regulations is that before a substance can be used for a medical purpose, its “chemistry must be scientifically established to permit it to be reproduced in dosages which can be standardized.” That would imply that cannabis or pharmaceutical companies would need to produce marijuana medication in measured doses that are FDA approved and only available by prescription.

There is little consistency in labeling, regulating or testing of cannabis.products sold in states where it is legal. Many products are mislabeled, with concentrations of CBD (cannabinoids) and THC (tetrahydrocannabinol) that are well above or below their label claims.

“It will be very interesting to see how DEA responds to this (HHS) recommendation, given the agency’s historic opposition to any potential change in cannabis’ categorization under federal law,” said Armentano. “Since the agency has final say over any rescheduling decision, it is safe to say that this process still remains far from over.”

Although nearly a third of U.S. adults with chronic pain have used cannabis as a pain reliever, professional medical associations have been reluctant to endorse its use. In 2021, the International Association for the Study of Pain (IASP) released a position statement saying it could not endorse the use of cannabinoids to treat pain, citing too many “uncertainties” about the clinical evidence.

Artificial Intelligence May Decide Whether You Get Rx Opioids

By Andy Miller and Sam Whitehead, KFF Health News

Elizabeth Amirault never heard of NarxCare until last year, when she learned its software was tracking her medication use. During a visit to a hospital in Fort Wayne, Indiana, Amirault told a nurse practitioner she was in severe pain and received a puzzling response.

“Your Narx Score is so high, I can’t give you any narcotics,” she recalled the man saying, as she waited for an MRI before a hip replacement.

Tools like NarxCare are used to help medical providers review controlled substance prescriptions. They influence, and can limit, the prescribing of painkillers, similar to a credit score influencing the terms of a loan. NarxCare’s overdose risk ratings – known Narx Scores -- are produced by health care technology company Bamboo Health (formerly Appriss Health).

NarxCare’s software uses artificial intelligence to analyze data about prescriptions for controlled substances to identify patterns of potential problems involving patients and physicians. State and federal health agencies, law enforcement officials, and health care providers have enlisted these tools, but the mechanics behind their algorithm formulas are generally not shared with the public.

Artificial intelligence is working its way into more parts of American life. As AI spreads within the health care landscape, it brings familiar concerns of bias and accuracy and whether government regulation can keep up with rapidly advancing technology.

The use of systems to analyze opioid-prescribing data has sparked questions over whether they have undergone enough independent testing outside of the companies that developed them, making it hard to know how they work. Lacking the ability to see inside these systems leaves only clues to their potential impact.

Some patients say they have been cut off from needed care. Some doctors say their ability to practice medicine has been unfairly threatened.

Researchers warn that such technology — despite its benefits — can have unforeseen consequences if it improperly flags patients or doctors.

“We’re concerned that it’s not working as intended, and it’s harming patients.”

— Jason Gibbons, Health Economist

“We need to see what’s going on to make sure we’re not doing more harm than good,” said Jason Gibbons, a health economist at the Colorado School of Public Health at the University of Colorado’s Anschutz Medical Campus. “We’re concerned that it’s not working as intended, and it’s harming patients.”

Amirault, 34, said she has dealt for years with chronic pain from health conditions such as sciatica, degenerative disc disease, and avascular necrosis, which results from restricted blood supply to the bones.

The opioid Percocet offers her some relief. Amirault had been denied the medication before, but never had been told anything about a Narx Score, she said.

In a chronic pain support group on Facebook, she found others posting about NarxCare, which scores patients based on their supposed risk of prescription drug misuse. She’s convinced her ratings negatively influenced her care.

“Apparently being sick and having a bunch of surgeries and different doctors, all of that goes against me,” Amirault said.

Database-driven tracking has been linked to a decline in opioid prescriptions, but evidence is mixed on its impact on curbing the epidemic. Overdose deaths continue to plague the country, and patients like Amirault have said the monitoring systems leave them feeling stigmatized as well as cut off from pain relief.

The Centers for Disease Control and Prevention estimated that in 2021 about 52 million American adults suffered from chronic pain, and about 17 million people lived with pain so severe it limited their daily activities. To manage the pain, many use prescription opioids, which are tracked in nearly every state through electronic databases known as prescription drug monitoring programs (PDMPs).

The last state to adopt a program, Missouri, is still getting it up and running.

More than 40 states and territories use the technology from Bamboo Health to run PDMPs. That data can be fed into NarxCare, a separate suite of tools to help medical professionals make decisions. Hundreds of health care facilities and five of the top six major pharmacy retailers also use NarxCare, the company said.

The platform generates three Narx Scores based on a patient’s prescription activity involving narcotics, sedatives, and stimulants. A peer-reviewed study showed the “Narx Score metric could serve as a useful initial universal prescription opioid-risk screener.”

NarxCare’s algorithm-generated “Overdose Risk Score” draws on a patient’s medication information from PDMPs — such as the number of doctors writing prescriptions, the number of pharmacies used, and drug dosage — to help medical providers assess a patient’s risk of opioid overdose.

Bamboo Health did not share the specific formula behind the algorithm or address questions about the accuracy of its Overdose Risk Score but said it continues to review and validate the algorithm behind it, based on current overdose trends.

Guidance from the CDC advised clinicians to consult PDMP data before prescribing pain medications. But the agency warned that “special attention should be paid to ensure that PDMP information is not used in a way that is harmful to patients.”

This prescription-drug data has led patients to be dismissed from clinician practices, the CDC said, which could leave patients at risk of being untreated or undertreated for pain. The agency further warned that risk scores may be generated by “proprietary algorithms that are not publicly available” and could lead to biased results.

(Editor’s note: A citizen’s petition filed with FDA earlier this year alleged that NarxCare software “altered the practice of medicine in the U.S. to the detriment of patients,” and sought to have the software declared a misbranded medical device and recalled. The petition by the Center for U.S. Policy was rejected by FDA on technical grounds because it was “not within the scope” of the agency’s petition process.)

Impact on Patients

Bamboo Health says NarxCare’s rating system should never replace decisions made by physicians. But some patients say the risk scores have had an outsize impact on their treatment.

Bev Schechtman, 47, who lives in North Carolina, said she has occasionally used opioids to manage pain flare-ups from Crohn’s disease. As vice president of the Doctor Patient Forum, a chronic pain patient advocacy group, she said she has heard from others reporting medication access problems, many of which she worries are caused by red flags from databases.

“There’s a lot of patients cut off without medication,” according to Schechtman, who said some have turned to illicit sources when they can’t get their prescriptions. “Some patients say to us, ‘It’s either suicide or the streets.’”

The stakes are high for pain patients. Research shows rapid dose changes can increase the risk of withdrawal, depression, anxiety, and even suicide.

Some doctors who treat chronic pain patients say they, too, have been flagged by data systems and then lost their license to practice and were prosecuted.

Lesly Pompy, a pain medicine and addiction specialist in Monroe, Michigan, believes such systems were involved in a legal case against him.

His medical office was raided by a mix of local and federal law enforcement agencies in 2016 because of his patterns in prescribing pain medicine. A year after the raid, Pompy’s medical license was suspended. In 2018, he was indicted on charges of illegally distributing opioid pain medication and health care fraud.

“I knew I was taking care of patients in good faith,” he said. A federal jury in January acquitted him of all charges. He said he’s working to have his license restored.

One firm, Qlarant, a Maryland-based technology company, said it has developed algorithms “to identify questionable behavior patterns and interactions for controlled substances, and for opioids in particular,” involving medical providers.

The company, in an online brochure, said its “extensive government work” includes partnerships with state and federal enforcement entities such as the Department of Health and Human Services’ Office of Inspector General, the FBI, and the Drug Enforcement Administration.

In a promotional video, the company said its algorithms can “analyze a wide variety of data sources,” including court records, insurance claims, drug monitoring data, property records, and incarceration data to flag providers.

William Mapp, the company’s chief technology officer, stressed the final decision about what to do with that information is left up to people — not the algorithms.

Mapp said that “Qlarant’s algorithms are considered proprietary and our intellectual property” and that they have not been independently peer-reviewed.

“We do know that there’s going to be some percentage of error, and we try to let our customers know,” Mapp said. “It sucks when we get it wrong. But we’re constantly trying to get to that point where there are fewer things that are wrong.”

Prosecutions against doctors through the use of prescribing data have attracted the attention of the American Medical Association.

“These unknown and unreviewed algorithms have resulted in physicians having their prescribing privileges immediately suspended without due process or review by a state licensing board — often harming patients in pain because of delays and denials of care,” said Bobby Mukkamala, chair of the AMA’s Substance Use and Pain Care Task Force.

Even critics of drug-tracking systems and algorithms say there is a place for data and artificial intelligence systems in reducing the harms of the opioid crisis.

“It’s just a matter of making sure that the technology is working as intended,” said health economist Gibbons.

KFF Health News is a national newsroom that produces in-depth journalism about health issues.

New DEA Rule Allows Pharmacies to Transfer Opioid Prescriptions

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has adopted a new rule that allows patients, doctors and pharmacists to transfer initial prescriptions for opioids and other controlled substances from one pharmacy to another.  

The rule became effective August 28, but has been in the works for several years. It revises DEA regulations to allow prescribers, hospitals and pharmacists the ability to write, dispense and transfer electronic prescriptions for controlled substances “upon request of the patient.” Under the old rule, prescriptions could not be transferred if a pharmacy is unwilling or unable to fill them – forcing doctors to write a second prescription for another pharmacy and creating delays for patients in need of treatment.

“The final rule amends DEA regulations to explicitly state that an electronic prescription for a controlled substance in schedule II–V may be transferred between retail pharmacies for initial filling on a one-time basis only, upon request from the patient, and clarifies that any authorized refills included on a prescription for a schedule III, IV, or V controlled substance are transferred with the original prescription,” DEA said in a lengthy notice published in the Federal Register.

In recent years, many patients have experienced delays or outright refusals getting prescriptions filled for opioids, stimulants, sedatives, steroids and other medications classified as controlled substances.  The problem has grown worse in recent months, due to chronic shortages of oxycodone, hydrocodone and stimulants.

It would be nice to say the DEA changed the rule to make it easier for patients to get their prescriptions filled, but the agency’s primary goal is to reduce drug diversion. Having doctors write duplicate prescriptions for the same patient is not only a waste of time, in the eyes of the DEA it raises the risk of the original prescription being misused.

“DEA realizes that this scenario creates the potential for duplication of prescriptions, if the practitioner transmits a new prescription to a different pharmacy and does not cancel or void the original prescription that was sent to the first pharmacy. It also recognizes that this scenario creates additional burden for patients, who have to get back in touch with the prescribing practitioner to request a new prescription,” the agency said.

“DEA believes that allowing the electronic transfer of controlled substance prescriptions will decrease the potential for duplicate prescriptions and thus reduce the opportunity for diversion or misuse.”

The diversion of prescription opioids is actually rare. According to the DEA, less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) is lost, stolen or diverted to someone they were not prescribed to.

The DEA estimates the new prescription transfer rule will cost pharmacies over $91 million annually due to additional record-keeping and time spent transferring prescriptions, but will reduce overall costs to the healthcare system by $22 million a year.  

FDA Approves First Biosimilar for Multiple Sclerosis

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved Tyruko (natalizumab-sztn) as the first biosimilar for adults with relapsing forms of multiple sclerosis (MS), a move that could substantially reduce treatment costs for MS patients. Biosimilars are “highly similar” to brand-name biologic medicines, but about 30% cheaper.

"Approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA's longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost," said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars.

Like Tysabri (natalizumab), the biologic it is modeled after, Tyruko is administered by infusion every four weeks to patients with MS, a chronic disease that attacks the body’s central nervous system, causing numbness, paralysis, loss of vision, fatigue and pain. Many MS patients experience periods of remission, followed by relapses.  

The listed cash price for a single vial of Tysabri is over $17,000, although the discounted price for insured patients is about $8,500 or $102,000 a year. Sandoz, a pharmaceutical company that specializes in biosimilars and generics, has not revealed its pricing plans for Tyruko or said when it will become available. Sandoz is a division of Novartis.

“Of the nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market,” Keren Haruvi, President North America, Sandoz Inc., said in a news release.

Like Tysabri, Tyruko may also be used to treat adults with moderate to severe symptoms from Crohn's disease who have not responded well to other treatments. Crohn’s causes chronic inflammation in the digestive tract.

The FDA says patients using natalizumab products (including Tyruko and Tysabri) are at higher risk of developing progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that can lead to death or severe disability. Because of that risk, prescribers must evaluate patients three and six months after their first infusion, every six months thereafter, and even after they discontinue treatment.

Growing Market for Biosimilars

Patients have long complained about the high price of MS drugs in the US, which cost two to three times more than the same drugs in Canada, Australia or the UK. One reason biologics are so expensive is that they derived from living organisms such as animal cells or bacteria, making them costly to develop.

Drug patents also last a long time – usually five years – before a “copycat” version can be introduced. Patent holders often take their competitors to court to further delay the introduction of generics or biosimilars, as was the case with AbbVie’s Humira, a biologic widely used to treat rheumatoid arthritis and other chronic inflammatory diseases. At least 9 new Humira biosimilars are finally entering the U.S. market this year.

Last week, CVS Health announced that it was launching a wholly owned subsidiary called Cordavis, which will work with drug manufacturers to commercialize biosimilars. The first biosimilar CVS plans to market in early 2024 is Hyrimoz (adalimumab-adaz), a biosimilar for Humira produced by Sandoz. CVS says the list price of the Hyrimoz will be over 80% lower than the current list price of Humira.

"Biosimilars are crucial to creating competition and reducing costs for specialty pharmaceuticals where drug prices are rising the fastest," said Prem Shah, PharmD, Executive Vice President and Chief Pharmacy Officer for CVS. "Through our direct involvement, we will expand the supply chain and ensure biosimilar availability in the market.”

As more patents expire, the biosimilars market in the U.S. is projected to grow from $6.7 billion in 2021 to more than $100 billion in 2029, according to one market forecast..

What Is End-of-Life Care?

By Dr. Forest Tennant and Kristen Ogden

The Medical Board of California’s new Guidelines for Prescribing Controlled Substances for Pain are futuristic and practical.  They recognize that persons who need intractable pain or “end-of-life” care may often require a non-standard medical program, so the board made these two conditions exempt from any limitations on dosage or treatment.

In our recent column on the guidelines, we clarified the meaning of intractable pain and suggested criteria for identification of the intractable pain patient who requires non-standard drugs and dosages. This column does the same for “end-of-life” care. 

The California guidelines define end-of-life care as “for persons with a terminal illness or at risk of dying in the near future whether in hospice care, hospitals, long-term care or at home.”  Note that this definition does not include palliative care, whose definition is frankly now in limbo, because medical textbooks define it as “symptomatic rather than curative care.” Third party payers only recognize palliative care as being in the last few months of life.

How does one identify a person who needs “end-of-life” care?  California actually has a law which helps identify the person who needs end-of-life care.  Such a person “is suffering from an incurable and irreversible illness that will bring about death within one year if the illness takes its normal course and the treatment is for pain control and/or symptom management rather than to cure the illness.” 

In effect, this definition includes intractable pain patients who are not expected to live more than a year without treatment.  Severe intractable pain, regardless of cause, if left untreated will result in malnutrition, immune deficiency, cardiac or adrenal failure, and a shorter life. 

To our knowledge there are no formal criteria published for clinicians to determine when there exists high risk of death within a year.  Here are criteria used and suggested by us: 

1. Patient has a known disease that may shorten life, such as cancer, adhesive arachnoiditis, head trauma, and Ehlers-Danlos syndromes.

2. Pain is constant and interferes with activities of daily living as reported by a close family member.  Examples are inability to eat, toileting, mobility, hygiene, and dressing.

3. Bed bound and immobile for many hours of each day.

4. Malnutrition, evidence of tissue loss, poor skin turgor (rigidity), and/or weight loss.

5. Family reports inability to normally read, answer questions, or socially respond.

6. Some alterations in normal physiologic functions such as blood pressure, pulse, and hormone levels.

We encourage clinicians to use our criteria for “end-of-life” care or develop some specific alternative criteria.  Too many seriously ill intractable pain patients have been denied care until it was too late.  An “end-of-life” case may begin at any age, be it 14, 40 or 80 years old. 

Many, if not most “end-of-life” patients meet terminus within a year. But some persons turn things around with adequate intractable pain care and live much longer.

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain. The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

Kristen Ogden is a patient advocate from Virginia. Kristen and her husband Louis travel regularly to California for his intractable pain treatment and prescriptions, which are not available in their home state.