Algorithms Now Determine If You Get Medication

By Crystal Lindell, PNN Columnist

Did you know that secret algorithms are being used to determine whether your pharmacy is allowed to stock certain medications?

Algorithms are computer software programs designed to select, calculate and carry out certain actions – in this case the amount of opioids and other controlled substances that pharmacies can keep in stock to fill prescriptions with. And if an algorithm decides your pharmacy has used up its monthly allotment of a controlled drug, there’s almost no recourse for you as a patient.

The situation was recently brought into the spotlight by The New York Times article, “Opioid Settlement Hinders Patients’ Access to a Wide Array of Drugs.”

As The Times explains, the $21-billion opioid settlement brokered between the three largest U.S. drug distributors and 46 states includes a provision that forces the distributors to place strict limits on the drugs they supply to pharmacies. In addition to opioids, any medication labeled as a controlled substance is now subject to these restrictions, including Xanax, Adderall, muscle relaxants, and more.

“Before the settlement, pharmacists said, they could explain to a distributor the reason for a surge in demand and still receive medications past their limits. Now the caps appear to be more rigid: Drugs are cut off with no advance notice or rapid recourse. As a condition of the settlement, distributors cannot tell pharmacies what the thresholds are,” The Times reported.

So, like I said, secret algorithms are effectively deciding your medical treatment. And it’s not even based on you as an individual. It’s based on how many people in your region are taking the same medication.

Predictably, the situation is causing a lot of problems for a lot of people. The Times found that a number of groups have been affected, including:

  1. “College students far from home trying to fill their Adderall prescription.”

  2. “Patients in rural areas where it is customary to drive long distances for medical care.”

  3. “Hospice providers that rely on local pharmacies for controlled substances.”

Let’s take a moment to truly absorb that last one. While the The Times used the term “hospice providers,” we all know what that actually means: hospice patients who are very sick or terminally ill.

So, it doesn’t even matter if you’re on your deathbed, you still might not get pain relief. And the decision for denial, to paraphrase how a pharmacist might explain it, is basically: “A bunch of your neighbors already got morphine, so you can’t have it.”

While the exact metrics used to deny shipments aren’t public, the drug distributors have addressed the issue on their websites, and explained how they’re tracking prescriptions.

“The algorithm will flag order lines of unusual size, frequency or pattern based on a pharmacy’s own order history or when compared to peers,” AmerisourceBergen explains. “Any order lines that are flagged by the algorithm will be automatically cancelled and reported.” 

Again, none of that is based on what any specific patient is experiencing.

All of this would be upsetting if it were only impacting opioid medication, but the fact that it’s been extended to other common prescriptions – that weren’t even part of opioid litigation -- is both enraging and scary.

Doctors do not give prescriptions for any controlled substances out easily, so if a patient is being prescribed any of the meds, then they need them.

Now, you may assume that at the very least, pharmacies are calling doctors once they hit these new thresholds so that the doctor can at least try to prescribe something else or send the prescription to another pharmacy.

You’d be wrong.

As the The Times reports:

“Psychiatrists in California were so alarmed by patients’ stories of unfilled prescriptions that they sent a survey to colleagues in December. They received reports of dozens of such problems, said Dr. Emily Wood, chairwoman of the government affairs committee of the California State Association of Psychiatrists.

Dr. Wood said that patients who take a stimulant for A.D.H.D. sometimes need anti-anxiety pills or a sedative at night to sleep — but that pharmacists now tell them they cannot have the combination.

“Pharmacists aren’t calling the doctors to work it out,” Dr. Wood said. “They’re just not filling the prescriptions.”

Pharmacists are being put in an impossible position, being forced to essentially serve as police agents without any say in what they’re enforcing. And it’s upsetting that the task of reaching a doctor to ask for a different prescription is now falling on patients with conditions like ADHD, a disorder that makes tasks like that especially difficult.

I couldn’t find much about how these algorithms were created, so it’s unclear if doctors were involved in creating them. But one thing we do know is that your personal doctor definitely wasn’t involved. And your personal needs were not a factor.

Your medical treatment is now being determined by drug distributors, state attorneys general, lawyers and computers — none of whom have ever met you or your doctor.

The thing that most people in the United States don’t seem to understand — but may be about to learn — is that to the DEA anyone who uses a controlled substance above a certain level must be abusing them. This is evidenced by the fact that this policy is even leading to restrictions for hospice patients and none of the parties involved are trying to fix that.

As the The Times reports, “Although the tighter restrictions have been in place for months, the government has offered little remedy for patients.”

It’s easy to believe the myth that restrictions on controlled substances are there to help keep us safe. That they are only meant to keep these medications from people who might misuse or abuse them.  But how is it safe to make a patient quit Adderall cold turkey, even when they have a valid prescription for it? How is it safe to tell rural patients that they need to drive hundreds of miles to another pharmacy? How is it safe to deny pain relief to a dying cancer patient? It’s not.

Everything about this situation is so inhumane. We’ve had incredible medical breakthroughs and finally have medications available for health conditions once considered untreatable. But it doesn’t matter. The masses still can’t have them. We must continue to suffer for whatever time we have left.

And for what? What is the reward for our suffering? Apparently, just more suffering.

Crystal Lindell is a freelance writer who lives in Illinois. After five years of unexplained rib pain, Crystal was finally diagnosed with hypermobile Ehlers-Danlos syndrome. She and her fiancé have 3 cats: Princess Dee, Basil, and Goose. She enjoys the Marvel Cinematic Universe, Taylor Swift Easter eggs, and playing the daily word game Semantle. 

New CDC Guideline: Too Little, Too Late for Chronic Pain Patients

By Sam Whitehead and Andy Miller, Kaiser Health News

Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain.

“A lot of them are straight-up insulting,” said the 40-year-old, who lives in Dallas. “They say things like ‘We don’t treat drug addicts.’”

Layman has tried a host of non-opioid treatments to help with the intense daily pain caused by double scoliosis, a collapsed spinal disc, and facet joint arthritis. But she said nothing worked as well as methadone, an opioid she has taken since 2013.

The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won't do the same. “If something should happen to him, there's nowhere for me to go,” she said.

Layman is one of the millions in the U.S. living with chronic pain. Many have struggled to get opioid prescriptions written and filled since 2016 guidelines from the Centers for Disease Control and Prevention inspired laws cracking down on doctor and pharmacy practices. The CDC recently updated those recommendations to try to ease their impact, but doctors, patients, researchers, and advocates say the damage is done.

“We had a massive opioid problem that needed to be rectified,” said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that analyzes prescription drug pricing. “But the federal crackdowns and guidelines have created collateral damage: patients left high and dry.”

Born of an effort to fight the nation’s overdose crisis, the guidance led to legal restrictions on doctors’ ability to prescribe painkillers. The recommendations left many patients grappling with the mental and physical health consequences of rapid dose tapering or abruptly stopping medication they’d been taking for years, which carries risks of withdrawal, depression, anxiety, and even suicide.

Opioid Guideline Revised

In November, the agency released new guidelines, encouraging physicians to focus on the individual needs of patients. While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use.

But some doctors worry the new recommendations will take a long time to make a meaningful change — and may be too little, too late for some patients. The reasons include a lack of coordination from other federal agencies, fear of legal consequences among providers, state policymakers hesitant to tweak laws, and widespread stigma surrounding opioid medication.

The 2016 guidelines for prescribing opioids to people with chronic pain filled a vacuum for state officials searching for solutions to the overdose crisis, said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School.

The dozens of laws that states passed limiting how providers prescribe or dispense those medications, she said, had an effect: a decline in opioid prescriptions even as overdoses continued to climb.

The first CDC guidelines “put everybody on notice,’’ said Dr. Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force. Physicians reduced the number of opioid pills they prescribe after surgeries, he said. The 2022 revisions are “a dramatic change,” he said.

The human toll of the opioid crisis is hard to overstate. Opioid overdose deaths have risen steadily in the U.S. in the past two decades, with a spike early in the covid-19 pandemic. The CDC says illicit fentanyl has fueled a recent surge in overdose deaths.

Taking into account the perspective of chronic pain patients, the latest recommendations try to scale back some of the harms to people who had benefited from opioids but were cut off, said Dr. Jeanmarie Perrone, director of the Penn Medicine Center for Addiction Medicine and Policy.

“I hope we just continue to spread caution without spreading too much fear about never using opioids,” said Perrone, who helped craft the CDC’s latest recommendations.

Christopher Jones, director of the CDC’s National Center for Injury Prevention and Control, said the updated recommendations are not a regulatory mandate but only a tool to help doctors “make informed, person-centered decisions related to pain care.”

Multiple studies question whether opioids are the most effective way to treat chronic pain in the long term. But drug tapering is associated with deaths from overdose and suicide, with risk increasing the longer a person had been taking opioids, according to research by Dr. Stefan Kertesz, a professor of medicine at the University of Alabama-Birmingham.

He said the new CDC guidance reflects “an extraordinary amount of input” from chronic pain patients and their doctors but doubts it will have much of an impact if the FDA and the Drug Enforcement Administration don’t change how they enforce federal laws.

Patients Still Not Getting Needed Medication

The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. The DEA, which investigates physicians suspected of illegally prescribing opioids, declined to comment.

The DEA’s pursuit of doctors put Danny Elliott of Warner Robins, Georgia, in a horrible predicament, said his brother, Jim.

In 1991, Danny, a pharmaceutical company rep, suffered an electric shock. He took pain medicine for the resulting brain injury for years until his doctor faced federal charges of illegally dispensing prescription opioids, Jim said.

Danny turned to doctors out of state — first in Texas and then in California. But Danny’s latest physician had his license suspended by the DEA last year, and he couldn’t find a new doctor who would prescribe those medications, Jim said.

Danny, 61, and his wife, Gretchen, 59, died by suicide in November. “I’m really frustrated and angry about pain patients being cut off,” Jim said.

Danny became an advocate against forced drug tapering before he died. Chronic pain patients who spoke with KHN pointed to his plight in calling for more access to opioid medications.

DANNY AND GRETCHEN ELLIOT

Even for people with prescriptions, it’s not always easy to get the drugs they need.

Pharmacy chains and drug wholesalers have settled lawsuits for billions of dollars over their alleged role in the opioid crisis. Some pharmacies have seen their opioid allocations limited or cut off, noted Ciaccia, with 3 Axis Advisors.

Rheba Smith, 61, of Atlanta, said that in December her pharmacy stopped filling her prescriptions for Percocet and MS Contin. She had taken those opioid medications for years to manage chronic pain after her iliac nerve was mistakenly cut during surgery, she said.

Smith said she visited nearly two dozen pharmacies in early January but could not find one that would fill her prescriptions. She finally found a local mail-order pharmacy that filled a one-month supply of Percocet. But now that drug, along with MS Contin, are not available, the pharmacy told her.

“It has been a horrible three months. I have been in terrible pain,” Smith said.

Many patients fear a future of constant pain. Layman thinks about the lengths she’d go to in order to get medication.

“Would you be willing to buy drugs off the street? Would you be willing to go to an addiction clinic and try to get pain treatment there? What are you willing to do to stay alive?” she said. “That is what it comes down to.”

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

Despite Pharma Claims, FDA Finds Few Rx Opioids Entering U.S. Illegally

By Phil Galewitz, Kaiser Health News

For years, the FDA has defended its efforts to intercept prescription drugs coming from abroad by mail as necessary to keep out dangerous opioids, including fentanyl.

The pharmaceutical industry frequently cites such concerns in its battle to stymie numerous proposals in Washington to allow Americans to buy drugs from Canada and other countries where prices are almost always much lower.

But the agency’s own data from recent years on its confiscation of packages containing drugs coming through international mail provides scant evidence that a significant number of opioids enters this way. In the two years for which KHN obtained data from the agency, only a tiny fraction of the drugs inspected contained opioids.

The overwhelming majority were uncontrolled prescription drugs that people had ordered, presumably because they can’t afford the prices at home.

The FDA still stops those drugs, because they lack U.S. labeling and packaging, which federal authorities say ensure they were made under U.S. supervision and tracking.

The FDA said it found 33 packages of opioids and no fentanyl sent by mail in 2022 out of nearly 53,000 drug shipments its inspectors examined at international mail facilities. That’s about 0.06% of examined packages.

According to a detailed breakdown of drugs intercepted in 2020, the lion’s share of what was intercepted — and most often destroyed — was pharmaceuticals. The No. 1 item was cheap erectile dysfunction pills, like generic Viagra. But there were also prescribed medicines to treat asthma, diabetes, cancer, and HIV.

U.S. CUSTOMS AND BORDER PROTECTION IMAGE

FDA spokesperson Devin Koontz said the figures don’t reflect the full picture because U.S. Customs and Border Protection is the primary screener at the mail facilities.

But data obtained from the customs agency shows it likewise found few opioids: Of more than 30,000 drugs it intercepted in 2022 at the international mail facilities, only 111 were fentanyl and 116 were other opioids.

Americans Pay Twice the Price

On average, Americans pay more than twice the price for exactly the same drugs as people in other countries. In polling, 7% of U.S. adults say they do not take their medicines because they can’t afford them. About 8% admit they or someone else in their household has ordered medicines from overseas to save money, though it is technically illegal in most cases. At least four states — Florida, Colorado, New Hampshire, and New Mexico — have proposed programs that would allow residents to import drugs from Canada.

While the FDA has found only a relatively small number of opioids, including fentanyl, in international mail, Congress gave the agency a total of $10 million in 2022 and 2023 to expand efforts to interdict shipments of opioids and other unapproved drugs.

“Additional staffing coupled with improved analytical technology and data analytics techniques will allow us to not only examine more packages but will also increase our targeting abilities to ensure we are examining packages with a high probability of containing violative products,” said Dan Solis, assistant commissioner for import operations at the FDA.

But drug importation proponents worry the increased inspections targeting opioids will result in more uncontrolled substances being blocked in the mail.

“The FDA continues to ask for more and more taxpayer money to stop fentanyl and opioids at international mail facilities, but it appears to be using that money to refuse and destroy an increasing number of regular international prescription drug orders,” said Gabe Levitt, president of PharmacyChecker.com, which accredits foreign online pharmacies that sell medicines to customers in the U.S. and worldwide. “The argument that importing drugs is going to inflame the opioid crisis doesn’t make any sense.”

“The nation’s fentanyl import crisis should not be conflated with safe personal drug importation,” Levitt said.

He was not surprised at the low number of opioids being sent through the mail: In 2022, an organization he heads called Prescription Justice received 2020 FDA data through a Freedom of Information Act request. It showed that FDA inspectors intercepted 214 packages with opioids and no fentanyl out of roughly 50,000 drug shipments.

In contrast, they found nearly 12,000 packages containing erectile dysfunction pills. They also blocked thousands of packages containing prescription medicines to treat a host of other conditions.

Over 90% of the drugs found at international mail facilities are destroyed or denied entry into the United States, FDA officials said.

In 2019, an FDA document touted the agency’s efforts to stop fentanyl coming into the United States by mail amid efforts to stop other illegal drugs.

Importing drugs from abroad simply for cost savings is not a good enough reason to expose yourself to the additional risks. The drug may be fine, but we don’t know, so we assume it is not.
— Devin Koontz, FDA

Levitt was pleased that Congress in December added language to a federal spending bill that he said would refocus the FDA mail inspections. It said the “FDA’s efforts at International Mail Facilities must focus on preventing controlled, counterfeit, or otherwise dangerous pharmaceuticals from entering the United States. Further, funds made available in this Act should prioritize cases in which importation poses a significant threat to public health.”

Levitt said the language should shift the FDA from stopping shipments containing drugs for cancer, heart conditions, and erectile dysfunction to blocking controlled substances, including opioids.

But the FDA’s Koontz said the language won’t change the type of drugs FDA inspectors examine, because every drug is potentially dangerous. “Importing drugs from abroad simply for cost savings is not a good enough reason to expose yourself to the additional risks,” he said. “The drug may be fine, but we don’t know, so we assume it is not.”

He said even drugs that are made in the same manufacturing facilities as drugs intended for sale in the United States can be dangerous because they lack U.S. labeling and packaging that ensure they were made properly and handled within the U.S. supply chain.

FDA officials say drugs bought from foreign pharmacies are 10 times as likely to be counterfeit as drugs sold in the United States.

To back up that claim, the FDA cites congressional testimony from a former agency official in 2005 who — while working for a drug industry-funded think tank — said between 8% and 10% of the global medicine supply chain is counterfeit.

The FDA said it doesn’t have data showing which drugs it finds are unsafe counterfeits and which drugs lack proper labeling or packaging. The U.S. Customs and Border Protection data shows that, among the more than 30,000 drugs it inspected in 2022, it found 365 counterfeits.

Pharmaceutical Research and Manufacturers of America, the trade group for the industry, funds a nonprofit advocacy organization called Partnership for Safe Medicines, which has run media campaigns to oppose drug importation efforts with the argument that it would worsen the fentanyl epidemic.

Shabbir Safdar, executive director of the Partnership for Safe Medicines, a group funded by U.S. pharmaceutical manufacturers, said he was surprised the amount of fentanyl and opioids found by customs and FDA inspectors in the mail was so low. He said that historically it has been a problem, but he could not provide proof of that claim.

He said federal agencies are not inspecting enough packages to get the full picture. “With limited resources we may be getting fooled by the smugglers,” he said. “We need to be inspecting the right 50,000 packages each year.”

Big Pharma’s Drug Monopoly

For decades, millions of Americans seeking to save money have bought drugs from foreign pharmacies, with most sales done online. Although the FDA says people are not allowed to bring prescription drugs into the United States except in rare cases, dozens of cities, county governments, and school districts help their employees buy drugs from abroad.

The Trump administration said in 2020 that drugs could be safely imported and opened the door for states to apply to the FDA to start importation programs. But the Biden administration has yet to approve any.

A federal judge in February threw out a lawsuit filed by PhRMA and the Partnership for Safe Medicines to block the federal drug importation program, saying it’s unclear when, if ever, the federal government would approve any state programs.

The pharmaceutical industry is using the FDA to protect their price monopoly to keep their prices high.
— Alex Lawson, Social Security Works

Levitt and other importation advocates say the process is often safe largely because the drugs being sold to people with valid prescriptions via international mail are FDA-approved drugs with labeling different from that found at U.S. pharmacies, or foreign versions of FDA-approved drugs made at the same facilities as drugs sold in the U.S. or similarly regulated facilities. Most drugs sold at U.S. pharmacies are already produced abroad.

Because of the sheer volume of mail, even as the FDA has stepped up staffing at the mail facilities in recent years, the agency can physically inspect fewer than 1% of packages presumed to contain drugs, FDA officials said.

Solis said the agency targets its interdiction efforts to packages from countries from which it believes counterfeit or illegal drugs are more likely to come.

Advocates for importation say efforts to block it protect the pharmaceutical industry’s profits and hurt U.S. residents trying to afford their medicines.

“We have never seen a rash of deaths or harm from prescription drugs that people bring across the border from verified pharmacies, because these are the same drugs that people buy in American pharmacies,” said Alex Lawson, executive director of Social Security Works, which advocates for lower drug prices. “The pharmaceutical industry is using the FDA to protect their price monopoly to keep their prices high.”

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

DEA to Reimpose ‘Guardrails’ on Telehealth Opioids

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration plans to reimpose rules that require doctors to meet face-to-face with patients before they are prescribed opioids and other controlled substances.

The rules were suspended in 2020 in the early stages of the Covid-19 pandemic so that doctors and patients could connect remotely via telehealth – also known as telemedicine --  to get medications prescribed without an in-person meeting.

But when the federal government ends the Covid public health emergency on May 11, the DEA plans to restore “appropriate safeguards” on medications it considers addictive. Patients will still be able to get prescriptions for antibiotics, statins, insulin and other common medications through telehealth, without a physical examination or meeting with a doctor.

“DEA is committed to ensuring that all Americans can access needed medications,” said DEA Administrator Anne Milgram said in a statement.  “The permanent expansion of telemedicine flexibilities would continue greater access to care for patients across the country, while ensuring the safety of patients. DEA is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm.”  

Under the DEA’s proposed rules, Schedule II controlled substances such as oxycodone and hydrocodone cannot be prescribed without first having an in-person meeting. Refills would then be allowed via telehealth.

Other drugs that are classified as Schedule III, IV or V substances – such as Xanax (alprazolam) and Suboxone (buprenorphine) could still be prescribed for 30 days via telehealth, but any refills will require an in-person meeting.

The DEA rules were developed in conjunction with the Department of Health and Human Services (HHS) and the Department of Veterans Affairs. Public comments on the rules can be submitted through the Federal Register by clicking here.

“Improved access to mental health and substance use disorder services through expanded telemedicine flexibilities will save lives,” said HHS Secretary Xavier Becerra. “We still have millions of Americans, particularly those living in rural communities, who face difficulties accessing a doctor or health care provider in-person.”

Drug overdoses rose sharply during the pandemic, with nearly 107,500 drug deaths reported in the 12-month period ending in August, 2022. About 70% of the fatal overdoses involved illicit fentanyl and other street drugs, not prescribed medications.

Pentagon Declares War on Poppy Seeds

By Pat Anson, PNN Editor

The U.S. Department of Defense is escalating its war against opioids beyond just oxycodone, hydrocodone and other pain medications.

In a February 17 memo, a top Pentagon official warned all military service members that eating foods containing poppy seeds could result in a failed drug test.

“Recent data suggests poppy seeds varieties may have higher codeine contamination than previously reported. Consumption of poppy seed products could cause a codeine positive urinalysis result and undermine the Department’s ability to identify illicit drug use. Out of an abundance of caution, I find protecting Service members and the integrity of the drug testing program requires a warning to avoid poppy seeds,” wrote Gilbert Cisneros, Jr., the Undersecretary of Defense for Personnel and Readiness.

Cisneros did not specific what the “recent data” was or where it came from. Tiny black seeds from the poppy plant – most of which come from Afghanistan -- can become contaminated during harvesting with trace amounts of codeine, morphine and other opiates. Drug users have found they can then use unwashed seeds to make a potent homemade tea to relieve pain.

Given how widely used washed poppy seeds are in muffins, cookies, salad dressings and cosmetics, the threat posed by them may sound rather comical. But some organizations take it very seriously.

The Center for Science in the Public Interest (CSPI) has petitioned the Food and Drug Administration to set a safe threshold for opiate alkaloids in imported poppy seeds, citing a study that claimed 19 people in the U.S. suffered fatal overdoses after ingesting poppy seeds in recent years.

“The time is overdue for the FDA to establish standards that will protect U.S. consumers from ingesting dangerous levels of opiates through the food supply,” said Peter Lurie, MD, President of CSPI.  

In 2019, the Drug Enforcement Administration even classified unwashed poppy seeds as a Schedule II controlled substance, claiming they were “qualitatively similar” to opioid pain medications.

“Unwashed poppy seeds are a danger to the user and their abuse may result in unpredictable outcomes including death,” the DEA said.

Eating poppy seeds could be risky for someone taking a drug test.  A 2020 study found that consuming just few seeds in a muffin or bagel could result in a positive drug test – a finding that could get a patient dismissed by their doctor or an employer refusing to hire a job applicant.

The Pentagon may also be trying to save money with its new directive. Simple urine drug screens performed in a doctor’s office are relatively cheap – and often wrong. False positive results should be confirmed with a mass spectrometry test performed in a laboratory, but those tests usually cost thousands of dollars.  It’s cheaper to just tell military personnel to stop eating bagels.

“The Military Departments are hereby directed to notify Service members to avoid consumption of all poppy seeds to include food products and baked goods containing poppy seeds. Service members are directed to work with their local legal office for any related concerns with urinalysis results,” Cisneros wrote in his memo.

The Pentagon and Department of Veterans Affairs (VA) have long taken a dim view of opioids. In recently updated medical guidelines, the agencies recommend that opioid medications not be used to manage non-cancer chronic pain.   

Limiting Supply of Rx Opioids Fails to Achieve Goals

By Pat Anson, PNN Editor

Limiting initial prescriptions for opioid pain medication to 5-days’ supply did not reduce the rate at which patients in New Jersey transitioned to long-term opioid use, according to a new study at Rutgers University.

In 2017, New Jersey became one of the first states in the country to impose a mandatory 5-day limit on initial opioid prescriptions for acute pain. If a patient needed more, their doctor would have to write a new prescription, enroll them in a pain management program, and counsel them on the risks of opioid addiction.

At least 38 other states adopted similar laws, with the goal of reducing opioid diversion, misuse and overdose. Six years later, there is little evidence that New Jersey’s 5-day limit saved lives or accomplished any of its goals.

“This policy’s apparent failure to achieve its goals illustrates the extreme difficulty of solving healthcare problems by dictating physician behavior,” said senior author Stephen Crystal, PhD, director of the Rutgers Center for Health Services Research.

Crystal and his colleagues analyzed pharmacy data for over 130,000 New Jersey Medicaid patients who were prescribed opioids for the first time between 2014 to 2019. Their findings, recently published in the Journal of General Internal Medicine, show that new opioid prescriptions fell at a monthly rate of less than one percent (0.76%) after the 5-day limit was imposed, a decline that was about half the monthly rate (1.62%) prescriptions were falling before the limit took effect.

Doctors were writing fewer prescriptions for opioids in New Jersey and other states long before limits on the supply were even passed. Opioid prescriptions nationally are now at their lowest level in over 20 years.

“Opioid prescribing was already decreasing before this policy went into effect,” said lead author Peter Treitler, a research project manager at the Rutgers Institute for Health, Health Care Policy and Aging Research. “And so, by the time this New Jersey policy went into effect, it really didn’t change prescribing practices very much, at least in the New Jersey Medicaid population.”

An earlier study by the Rutgers research team found that medically treated overdoses in the Medicaid population tripled in New Jersey after the 5-day limit was imposed. Most of the overdoses involved illicit fentanyl and other street drugs, not prescription opioids.

Less than a third of New Jersey’s overdose survivors were even diagnosed with a chronic pain condition, suggesting the state’s focus on limiting pain medication was misdirected. Most people who overdose suffer from substance abuse disorder, depression or other mental health issues. And most overdoses involve illicit fentanyl and other street drugs, not prescribed medication.

In 2022, there were nearly 2,900 drug deaths in New Jersey – about 30% more than the number that overdosed in 2016, the year before the state’s 5-day limit became law.  

New VA Guideline: Opioids Should Not Be Used for Chronic Pain

By Pat Anson, PNN Editor

The U.S. Department of Defense (DoD) and Department of Veterans Affairs (VA) have doubled down on a guideline first released in 2017 that strongly recommends against the use of opioids for chronic pain.

In an updated clinical practice guideline, the agencies continue to recommend that opioids not be used to manage chronic non-cancer pain, especially in younger patients, and that long-acting opioids not be used to treat patients with short-term, acute pain.

The VA/DoD guideline will potentially affect millions of service members, veterans and their families. Nearly 1.5 million Americans serve in the armed forces and over 800,000 in the National Guard and Reserves. The Veterans Administration provides health services to another 6 million veterans and their families.

The updated guideline was quietly released in May 2022, but is only drawing attention now in a mostly favorable review published in the Annals of Internal Medicine.

“Compared with the 2017 recommendation against initiation of long-term opioid therapy, the updated recommendation against opioid therapy in general for chronic pain is broader and reflects the evidence that opioid therapy for any duration may be harmful,” wrote lead author James Sall, PhD, Director of VA’s Office of Evidence-Based Practice.

“Ultimately, despite finding some evidence for a small improvement in musculoskeletal and noncancer neuropathic pain, the guideline development group maintained that the potential for catastrophic harms of opioids and serious adverse events, especially with long-term use, outweighed any potential benefits of temporarily improved pain severity and functional status in patients with chronic pain.”

‘Potentially Transformative’ for U.S. Healthcare

The updated opioid guideline has 20 recommendations, nine of which are based on weak or inconclusive evidence. Unlike the recently revised CDC opioid guideline, there were no public hearings or opportunities for the public to comment or provide input. There is also no discussion of dose thresholds or morphine milligram equivalents (MME), suggesting the authors believe that any dose of opioids is potentially risky.

Three new recommendations in the new VA/DoD guideline involve opioid tapering, mental health evaluations, and the use of buprenorphine to treat pain.

The guideline urges doctors to consider using buprenorphine instead of full agonist opioids for patients needing opioids daily for chronic pain. Although the quality of the evidence for this recommendation was deemed “insufficient,” the VA/DoD believe buprenorphine as a partial agonist has less risk for overdose and misuse, and is less likely to cause euphoria.

Buprenorphine is a Schedule III opioid that is FDA approved for pain when used alone. Buprenorphine is also used to treat opioid use disorder when combined with naloxone in drugs like Suboxone. The DEA recently eliminated the “X-Waiver” program for buprenorphine, which is likely to significantly increase the number of doctors that prescribe it and the number of patients that receive it.

An editorial published in the Annals of Internal Medicine called the recommendation that buprenorphine be used for pain “potentially transformative” and "likely to expand into the greater U.S. healthcare system."

"The updated VA/DoD guideline is both conservative and radical," wrote co-authors Chinazo Cunningham, MD, and Joanna Starrels, MD, both from Albert Einstein College of Medicine. "Although the VA/DoD guideline recommends that buprenorphine be prescribed for chronic pain if daily opioids are prescribed, the recommendation itself is likely to change decision-making about whether opioids should be prescribed."

Although several recent studies have found that opioid tapering significantly raises the risk of an overdose, withdrawal or mental health crisis, the VA/DoD guideline found there isinsufficient evidence to recommend for or against any specific tapering strategies.” It only recommends that doctors and patients “collaborate” on reducing opioid doses and that tapering not be forced.

“The potential benefits of opioid tapering outweighed the potential harms of opioid withdrawal,” the guideline claims.

Before opioids are prescribed for either acute or chronic pain, the guideline recommends that the mental health of patients be evaluated for depression, anxiety, psychotic disorders and suicide. Although some patients may resent being screened for mental health problems, the guideline says “it is better for providers to know about underlying behavioral health comorbidities than to initiate long-term opioids without this clinical knowledge.”

The revised guideline reaffirms previous recommendations that benzodiazepines not be co-prescribed with opioids and that patients on long-term opioid therapy be regularly screened with urine drug tests “to decrease the risk of self-directed violence.”

Opioid prescribing to veterans, family members and those on active duty has declined significantly in recent years, as it has for the rest of the population. The revised VA/DoD guideline notes – without a hint of irony – that reduced prescribing has led to an increased use of illicit opioids by veterans and higher overdose rates.

Opioid Tapering Disrupts Healthcare and Worsens Doctor-Patient Relationships 

By Pat Anson, PNN Editor

Tapering patients on long-term opioid therapy results in more emergency department visits and hospitalizations, according to a large new study that found reduced opioid use was particularly disruptive to the healthcare of pain patients with diabetes and high blood pressure.

The study by researchers at University of California Davis is the latest to document the “unintended negative consequences” of policies that limit opioid prescribing. A previous study by the same research team found that tapering raises the risk of an overdose and mental health crisis.

In their latest study, UC Davis researchers analyzed health data for over 113,000 patients who were on opioid therapy for at least 12 months, comparing those who were not tapered to those who had their dose reduced by 15% or more.

Their findings, published in JAMA Network Open, showed that tapering significantly increased hospitalizations and ED visits, while at the same time reducing the number of primary care (PC) visits. Researchers think the latter is at least partially due to “ruptures in relationships” with primary care providers (PCPs) due to patient dissatisfaction with tapering.

Opioid tapering was also associated with a significant reduction in patients taking medication for hypertension or diabetes – even though their blood pressure and blood sugar levels rose when their opioid doses were reduced.

“Tapering may be associated with reduced medication adherence due to an increased patient focus on managing pain and psychological distress due to the taper, disruption in PC due to more frequent ED visits and hospitalizations, or fracture of the PCP-patient relationship,” wrote lead author Elizabeth Magnan, MD, a family medicine physician at UC Davis Medical Center.

“Although cautious interpretation is warranted, these outcomes may represent unintended negative consequences of opioid tapering in patients who were prescribed previously stable doses.” 

Opioid prescribing has fallen dramatically in the U.S. over the past decade, particularly after the release of the CDC’s 2016 opioid guideline. Although millions of patients were affected by the guideline’s recommendations, few efforts were made at the federal level to see what happened to patients who had their opioid doses reduced or even stopped.

A recent study found the number of cancer patients seeking treatment for pain in emergency departments has doubled. Of the 35 million ED visits made by cancer patients, over half were deemed preventable – meaning the visits could have been avoided if the patient has received proper care earlier.

Mexican Pharmacies Sell Counterfeit Drugs to U.S. Tourists

By Pat Anson, PNN Editor

With opioid pain medication increasingly harder to obtain in the United States, a growing number of Americans are heading south of the border to get painkillers and other prescription drugs in Mexico.  That’s a risky activity, according to UCLA researchers, who found it was fairly common for Mexican pharmacies to sell counterfeit medication to unsuspecting tourists.

The researchers visited 40 pharmacies in Northern Mexico and purchased samples of oxycodone, hydrocodone, Xanax and Adderall, most of which were obtained without a prescription. Immunoassay testing strips were then used to check each pill for the presence of fentanyls, benzodiazepines, amphetamines and methamphetamines.

Eleven of the 40 pharmacies were found to be selling counterfeit drugs. Of the 27 “oxycodone” tablets purchased, 11 were made with either illicit fentanyl or heroin. One pill sold as “Vicodin” only contained lactose and the weaker opioid tramadol.

Nine of the 11 “Adderall” pills contained methamphetamine, while none of the Xanax pills were found to be counterfeit.  

The study findings were first reported online in medRxiv, a website that publishes new medical research before it is peer-reviewed.

FAKE OXYCODONE PILLS

“It is not possible to distinguish counterfeit medications based on appearance, because authentic and counterfeit versions are often sold in close geographic proximity and are visually and otherwise indistinguishable from one another. Nevertheless, US tourists may be more trusting of controlled substances purchased directly from pharmacies,” the UCLA researchers said, noting that overdoses are poorly monitored in Mexico, making it difficult to know how many people have died from taking counterfeit pills.

Researchers say the growing trade in counterfeit drugs – both north and south of the border – is due in part to a decade-long crackdown on prescription opioids. Since 2010, opioid prescriptions in the U.S. have fallen by nearly 50 percent.

“These decreases have been shown to have affected many patients with known painful chronic conditions, including terminal cancer, and other palliative care patients. Many patients have been rapidly tapered off opioid regimens, which has been associated with increased rates of suicide and drug overdose. A large unmet demand for diverted and legitimate prescription opioids has led to widespread consumption of counterfeit opioids in the US by witting and unwitting consumers,” researchers said.

One such case involves Jessica Fujimaki, a 42-year-old intractable pain patient, who lost access to opioids after the DEA suspended her doctor’s license to prescribe controlled substances last November. Desperate for relief and going into withdrawal, Fujimaki and her husband made two trips to Mexico from their home in Arizona to buy opioids, but were uncertain of the quality of drugs they purchased. She died in December.   

‘These Are Really Strong!’

Perhaps the most widely available counterfeit drug is “Mexican Oxy” – small blue pills that are designed to look like 30mg oxycodone pills. One of the UCLA researchers asked for oxycodone when he visited a Mexican pharmacy:

“We head into the pharmacy and ask for Oxy. The pharmacy employee flashes us a smile and says ‘I have Mexican Oxy or I have American Oxy. American Oxy is 35$ for 20mg, and Mexican Oxy is 20$ for 30mg.’

‘Why is the Mexican Oxy stronger and cheaper?’ I ask.

‘Oh the Mexican oxy is very strong, but it’s cheaper because they give it to us for cheaper,’ he says. ‘You should only take half, and even that’s going to be a lot. The full one might be too dangerous.’

I say, ‘Okay, we’ll take the Mexican Oxy.’ He goes under the counter and pulls out a cardboard box full of syringes. He reaches underneath the needles, and pulls up this false bottom on the box, and the bottom is full of these little blue pills, just loose in the box.

He takes one out of the pile and puts it in a little plastic bag for us. As he hands it to me. He’s says, ‘Okay guys, these are really strong! Please be careful.’”

When that “Mexican Oxy” pill was analyzed later, it tested positive for fentanyl.  

Two reporters for the Los Angeles Times recently found how easy it is to get counterfeit medication in Mexico when they visited pharmacies in Tijuana, Cabo San Lucas and several other northwestern cities. The reporters found that 71% of the 17 pills they purchased were fake. The “oxycodone” and “hydrocodone” pills tested positive for fentanyl, while pills sold as “Adderall” tested positive for methamphetamine.

Asked to comment on the Times investigation, the U.S. State Department, DEA and the White House Office of National Drug Control Policy failed to respond to repeated inquiries. Local and national government agencies in Mexico also ignored requests for comment.

Most of the drug experts interviewed by the Times said they’d never before heard of pharmacies selling counterfeit pills.

“I haven’t seen anything like that,” said Cecilia Farfán-Mendez, a researcher at UC San Diego’s Center of U.S.-Mexican Studies. “I think it speaks to the lack of law enforcement monitoring what’s happening in the pharmacies.”

Most Antidepressants Ineffective for Chronic Pain

By Pat Anson, PNN Editor

Most of the antidepressant drugs that are prescribed for chronic pain are either ineffective or the evidence supporting their use as pain relievers is weak, according to a new analysis published in The British Medical Journal (BMJ).

The use of antidepressants such as duloxetine (Cymbalta) and fluoxetine (Prozac) has doubled in recent years, with much of the increase due to their off-label prescribing to treat conditions such as fibromyalgia, neuropathy and back pain.

But in a review of 26 studies on the analgesic effects of antidepressants, Australian researchers found little evidence to support their use in pain management. The data on side effects was also weak, meaning the safety of antidepressants was also uncertain. Nearly half of the studies had ties or funding from the pharmaceutical industry.

“Recommending a list of antidepressants without careful consideration of the evidence for each of those antidepressants for different pain conditions may mislead clinicians and patients into thinking that all antidepressants have the same effectiveness for pain conditions. We showed that is not the case,” said lead author Giovanni Ferreira, PhD, from The Institute for Musculoskeletal Health at the University of Sydney.

“Some antidepressants were efficacious for some pain conditions; however, efficacy appears to depend on the condition and class of antidepressant. The findings suggest that a more nuanced approach is needed when prescribing antidepressants for pain.”

Ferreira and his colleagues say no study provided high quality evidence on the effectiveness of antidepressants for any pain condition. 

But they did find moderate quality evidence supporting the use of serotonin-norepinephrine reuptake inhibitors (SNRIs) for back pain, postoperative pain, fibromyalgia and neuropathic pain. Low-quality evidence suggested that SNRIs could be used for pain linked to breast cancer treatment, depression, knee osteoarthritis, and pain related to other underlying conditions.

The researchers say only low-quality evidence supports the use of selective serotonin reuptake inhibitors (SSRIs) for depression and pain related to other conditions; and tricyclic antidepressants (TCAs) as a treatment for irritable bowel syndrome, neuropathic pain, and chronic tension-type headaches. 

Antidepressants ‘Disappointing’ for Most Pain Patients

An accompanying editorial, also published in The BMJ, said the study adds to growing evidence that many medications prescribed for pain – not just antidepressants – are only modestly effective.

“Their findings suggest that for most adults living with chronic pain, antidepressant treatment will be disappointing. This is important given emerging concerns about increases in the prescribing of antidepressants and the challenges patients describe when trying to withdraw from treatment,” wrote Cathy Stannard, MD, UK National Health Service, and Colin Wilkinson, a pain patient and consultant at Centre for Pain Research, University of Bath.

“Clinicians continue to prescribe medicines for which the evidence is poor because they observe that some people respond to them, albeit modestly. But all medicines carry risk of harm and there are other, less potentially harmful options more likely to help people to live well with pain.”

Stannard and Wilkinson said exercise and physical activity might be better options than medication for some patients.

Ironically, a little over a year ago, the UK’s National Institute for Health and Care Excellence (NICE) released new guidelines that recommend antidepressants for adults with chronic primary pain, even when they are not depressed. NICE said antidepressants may help with quality of life, pain, sleep and psychological distress.

The NICE guideline is at odds with other studies that found antidepressants are minimally effective for back pain and osteoarthritis and often have adverse side effects. A common complaint of patients who take Cymbalta, for example, is how quickly they became dependent on the drug and have severe withdrawal symptoms when they stop taking it.

Medical Cannabis Reduced Opioid Use in High Dose Patients

By Pat Anson, PNN Editor

In recent years, there have been several studies and surveys – most of them anecdotal -- suggesting that cannabis reduces the need for opioid pain medication. A large new study takes that research a step further, finding direct evidence that chronic pain patients, including those on high doses, significantly reduced their opioid use once they started using medical cannabis.

Researchers with the New York State Department of Health and University of Albany School of Public Health followed over 8,100 patients on long-term opioid therapy (LOT) after they began using medical cannabis. All of the patients had been on opioids for at least 120 days, including some on relatively high daily doses of 90 or more morphine milligram equivalents (MME).

Researchers found that average daily doses declined significantly over time, especially for patients on high opioid doses. After eight months of using medical cannabis (MC), patients taking over 90 MME saw their daily doses fall by nearly 70 percent, compared to a 29% reduction in those getting 50 to 90 MME and a 15% reduction in those on 50 MME or less.

“This cohort study found that receiving MC for longer was associated with opioid dosage reductions. The reductions were larger among individuals who were prescribed higher dosages of opioids at baseline. These findings contribute robust evidence for clinicians regarding the potential benefits of MC in reducing the opioid burden for patients receiving LOT and possibly reduce their risk for overdose,” researchers reported in JAMA Network Open.

The study has some weaknesses. Researchers did not track the pain levels of patients or the types of pain conditions they suffered from. Also unknown is the dose or types of cannabis products they consumed.   

Although the study was conducted at a time when patients nationwide were losing access to opioids or having their doses reduced, researchers say it is “highly unlikely” that impacted their findings because the dosage decline for their patients didn’t begin until they started consuming cannabis.  

Marijuana advocates cheered the study findings.  

“The relationship between cannabis and opioid use is among of the best-documented aspects of marijuana policy,” Paul Armentano, Deputy Director of NORML, said in a statement. “In short, the science demonstrates that marijuana is a relatively safe and effective pain reliever — and that patients with legal access to it consistently reduce their use of prescription opioid medications.” 

A similar study of over 500 chronic pain patients being treated at medical cannabis clinics found a significant decline in their pain levels. And 85% of patients reported they either reduced or stopped using opioids.

DEA Lifts Limits on Buprenorphine Use

By Pat Anson, PNN Editor

After years of strict limits on the number of patients that a provider can treat with buprenorphine, it’s suddenly a lot easier to prescribe the drug for opioid use disorder (OUD). The Drug Enforcement Administration has eliminated the “X-Waiver” program for buprenorphine, a move required by Congress under the 2023 Appropriations Act.  

Elimination of the X-Waiver removes all patient caps and significantly increases the number of providers that can treat OUD with buprenorphine, a long-acting opioid similar to methadone. When combined with naloxone, an overdose prevention drug, buprenorphine reduces opioid cravings and eases withdrawal. Prescriptions for Suboxone and other buprenorphine/naloxone combinations now only require a provider to get a standard DEA registration for controlled substances.

“DEA fully supports this significant policy reform. ln this moment, when the United States is suffering tens of thousands of opioid-related drug poisoning deaths every year, the DEA 's top priority is doing everything in our power to save lives. Medication for opioid use disorder helps those who are fighting to overcome opioid use disorder by sustaining recovery and preventing overdoses,” DEA Administrator Anne Milgram wrote in a January 12 letter to providers.

The DEA is also developing a new mandatory eight-hour training program for providers to help them identify and treat OUD when they apply for or renew their registrations. The new training will be required on June 21.

“I think this is overdue. Buprenorphine can reduce the risks of overdose by 60% and is much safer than methadone,” says Lynn Webster, MD, an expert in pain management who is a Senior Fellow at the Center for U.S. Policy. “It would be controversial, but I believe low-dose buprenorphine should be OTC as a harm reduction measure. At least there should be a discussion about the potential benefit vs risk.”

Pressure to Prescribe

It remains to be seen how the elimination of the X-Waiver will affect pain patients. Over the years, we’ve heard complaints from patients who say they were coerced by their doctors into taking Suboxone, even though it’s not approved as a treatment for pain. With patient caps removed and more doctors able to prescribe buprenorphine, there could be added pressure on pain patients to take Suboxone – whether they show signs of OUD or not.

“I understand the pressure to use buprenorphine for pain rather than traditional opioids. It is a much safer opioid than most, so it should be considered as a first line therapy,” says Webster. “However, that is the rub. It is not effective or tolerated in many patients.  Patients have a legitimate concern that they may be coerced to transition to buprenorphine when their existing medications are working and there are no signs of abuse.     

“I don't think the change in regulations will mean more doctors will push their patients to use buprenorphine, because the mind-set is already there.” 

A little-known aspect of buprenorphine is that it blocks other opioids from working – meaning anyone who is taking it should be aware that if they have acute pain from an accident, trauma or surgery, they’ll have to rely on non-opioid pain relievers.  

While often touted as the most effective medication for OUD, most people who take buprenorphine relapse and starting taking opioids again. About two-thirds of the patients who receive Suboxone stop filling prescriptions for it after just three months. 

Although it’s difficult to get high on buprenorphine, it can still be misused. A 2021 study found the misuse rate for buprenorphine was over two times higher than misuse rates for hydrocodone, oxycodone and other opioid pain medications.

Doctor Convicted of Illegal Opioid Prescribing Imprisoned Before Sentencing

By Pat Anson, PNN Editor

A Louisiana doctor who federal prosecutors labeled as a "drug dealer in a white coat" has been taken into custody, weeks before he was scheduled to be sentenced for improperly prescribing opioid pain medication.

A jury found Randy Lamartiniere guilty last month on 20 counts of illegally distributing controlled substances outside the usual course of a medical practice. The 64-year old doctor was out on bail and scheduled for sentencing on March 30, but prosecutors wanted him taken into custody immediately after his conviction. A judge denied their motion, pending another court hearing on Tuesday, January 17.

“Needless to say this hearing is about as scary as it gets as I may or may not be taken into custody then. Kind of impossible to prepare for being incarcerated for 5-10 years in this situation,” Lamartiniere posted on his Facebook account prior to the hearing.

“There is no justification for pre-sentencing incarceration of course. I have an excellent chance of an appeal and a new trial and am hoping to stay out of prison altogether. Could use some support and kind thoughts at this extremely trying time. I’m more anxious about this than prior to my trial.”

Lamartiniere’s fears were justified, as the judge reversed his previous decision and had him taken into custody. According to Lamartiniere’s sister, he is now in a crowded holding cell with 18 other men, awaiting transfer to another facility.

Lamartiniere faces up to 400 years in prison when he’s sentenced in March – 20 years for each count – but is likely to get less under federal sentencing guidelines. It’s also possible he could be freed on bail again, pending his appeal.

Lamartiniere’s legal troubles date back several years. The Louisiana State Board of Medical Examiners issued an emergency order in 2015 suspending his license to prescribe opioids and other controlled substances. Despite the suspension, Lamartiniere kept writing “medically unnecessary prescriptions,” according to prosecutors, charging patients $100 to $300 per visit and taking payments only in cash. Baton Rouge police arrested him in 2016, but legal delays prevented his trial until last year.

As he awaited trial, Lamartiniere became active in the pain community, giving advice and encouragement to patients unable to find good pain care. Beau Brindley, Lamartiniere’s defense attorney, told jurors during closing arguments that he prescribed drugs in “good faith” to people he believed were in real pain.

“Taking the patient at face value is not a crime,” Brindley said, according to The Advocate. “He was an old-school doctor trying to manage patients in a new age world. … He was trying, and trying makes him not guilty. There is no way to prove that he was not making an honest effort.”

That “honest effort” will form the basis of Lamartiniere’s appeal, which is based in part on a recent U.S. Supreme Court decision in favor of two doctors who were also convicted of overprescribing opioids. Writing for the majority in that case, Justice Stephen Breyer said it was up to prosecutors to prove that doctors “knowingly or intentionally acted in an unauthorized manner" under the Controlled Substance Act.

So far the high court’s decision has had a mixed impact on other doctors in similar situations. Earlier this month, Dr. Lesley Pompy was acquitted by a Michigan jury of charges that he illegally distributed opioids and committed health care fraud. The charges stemmed from an investigation of Pompy that began in 2016.

More recently, the DEA suspended the license of Dr. David Bockoff, a California physician who was treating patients with severe pain conditions who required high-dose opioids. At least three people have died as a result of that suspension. Bockoff is currently appealing the DEA’s suspension.

Emergency Room Visits Soar for Cancer Patients Needing Pain Relief

By Pat Anson, PNN Editor

The number of cancer patients seeking treatment for pain in U.S. emergency departments has doubled in recent years, according to a large new study that further documents the harm caused to patients by misguided efforts to reduce opioid prescribing.

The study, conducted by a team of cancer researchers, looked at health data from 2012 to 2019 for millions of patients who had a cancer diagnosis and were not in remission.  Of the 35 million visits made to an emergency department (ED) by those patients, over half were deemed preventable – meaning the visits could have been avoided if the patient has received proper care earlier.

By a wide margin, pain was the most likely reason for a preventable ED visit. The number of cancer patients who went to an ED for poorly controlled pain rose from nearly 1.2 million in 2012 to 2.4 million in 2019. About a quarter of them had pain so severe they were admitted.  

“Consistent with previous studies, we found that pain was the most common presenting symptom (36.9%) in ED visits among patients with cancer and that the number of patients with cancer who visited an ED because of pain more than doubled over the study period,” lead author Amir Alishahi Tabriz, MD, a research scientist at the Moffitt Cancer Center in Florida, reported in JAMA Network Open.

“A possible explanation could be the unintended consequences of the efforts within the past decade to decrease overall opioid administration in response to the opioid epidemic.”

“I am not at all surprised by their result, as they are consistent with what I’m hearing from colleagues across the U.S.,” says Chad Kollas, MD, a palliative care physician and longtime critic of the 2016 CDC opioid guideline, which discouraged the prescribing of opioids for pain.

The CDC guideline was only intended for primary care physicians treating non-cancer pain, but it was quickly adopted throughout the U.S. healthcare system, including the field of oncology. Previous studies have documented how opioid prescriptions and doses declined for cancer patients, with the Cancer Action Network warning in 2019 that there has been “a significant increase in cancer patients and survivors being unable to access their opioid prescriptions.”

One of the most egregious cases involved April Doyle, a California woman with Stage 4 terminal breast cancer.  In 2019, Doyle posted a tearful video online after a pharmacist refused to fill her opioid prescription. She died about a year later, after the cancer metastasized into her lungs, spine and hip. 

“Unfortunately, the systematic misapplication of the 2016 Guideline created harms for patients due to reduced access to pain care and increased risk of suicide after nonconsensual or excessively rapid opioid tapers. These harms are predictable features of policy changes based on misguided calls for unfocused reductions in opioid prescribing,” Kollas told PNN.

Even if a cancer patient goes to an emergency room for pain relief, the odds of them — or any other patient — getting an opioid is dwindling. A new study by the National Center for Health Statistics found that the percentage of ED visits that ended with an opioid prescribed at discharge fell from 21.5% in 2010 to just 8.1% in 2020.

‘I Blame the CDC’

After years of complaints and bureaucratic delays, the CDC finally revised its opioid guideline in 2022 to more explicitly exclude patients undergoing cancer treatment, palliative care and end-of-life care. But many cancer patients felt it was too little, too late.

“My Mother had stage 4 terminal lung cancer. She was in horrible bone pain and her cancer doctor told her to take Tylenol for pain. We made several trips to the ER in the middle of the night just to manage her pain,” one woman told us. “She could not even enjoy her last moments on this earth with her family because of horrible cancer pain. As it spread all over, I could not help her. I am a nurse who watched her die miserably and I blame the CDC.”

“I live with stage 4 cancer and can't get any pain medication. I can't get any doctors to help me treat my pain,” another nurse told PNN. “My experience helps me understand why people become suicidal because they can't live with the pain anymore.”

“Stop making doctors afraid to treat pain adequately! I need a higher strength opioid for my chronic pain and my doctor will not up my strength because of that fear,” said another patient. “My husband has Stage 4 cancer and they refuse to up his strength as well. This is a crime against humanity!”

Over the past decade, there has been a seismic shift in prescribing practices and sharp declines in access to these medications for patients with cancer.
— Dr. Andrea Enzinger, Harvard Medical School

In another large study that looked at racial and ethnic disparities in the treatment of Medicare patients with advanced cancer, researchers saw a steady decline in opioid prescriptions and a rapid expansion in urine drug testing from 2007 to 2019. Their findings, published in the Journal of Clinical Oncology, show that less than a third of late-stage cancer patients received an opioid for pain control in 2019 and only 9.4% received a long-acting opioid near the end of life.

Black and Hispanic cancer patients were less likely to receive opioids than their White counterparts. They were also more likely to get smaller doses than White patients.

"Over the past decade, there has been a seismic shift in prescribing practices and sharp declines in access to these medications for patients with cancer,” said lead author Andrea Enzinger, MD, a gastrointestinal oncologist and assistant professor at Harvard Medical School. “Our findings are startling because everyone should agree that cancer patients should have equal access to pain relief at the end of life."

The Real Hoax About Prescription Opioids

By Barby Ingle, PNN Columnist

How many have to die? How many have to be denied? How many have to suffer unnecessarily?

Those are some of the questions I’m asking after reading a recent article in The Guardian about the CDC’s revised opioid guideline. The article has a few misstatements about prescription opioids that I have issues with. 

Before I share my take, I want readers to know that I do not take opioid medications myself. I have taken them in the past, but found other treatments that were more effective, so I stopped taking opioids in 2009. I also have an allergy to OxyContin, which I discovered after a knee surgery.

In 2018, I underwent pharmacogenomic testing, which I highly recommend for anyone who has chronic physical conditions. It has given me the best precision care available. I still live with multiple chronic pain and rare diseases, and will need treatment for the rest of my life.

You may be aware that I recently stepped down as president and a board member of the International Pain Foundation (iPain). It was a completely volunteer position. I have been advocating through many nonprofits since 2006 and have always been transparent about any funding that the charity or I received. I also have a degree from George Mason University in Psychology.

Which brings me back to the claims about addiction, opioids and patient advocacy that Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing (PROP), made in The Guardian article. This quote is from Kolodny about patient suicides:

“This is a really serious issue. But what the opioid advocates, many with industry ties, disclosed or undisclosed, pushed was this false narrative about an epidemic of suicide and so there was a manufactured backlash against the CDC guidelines.

“The notion that there are patients losing access to an effective treatment, and therefore they have no choice but to kill themselves because they’re in so much pain now, that’s a hoax. But the idea that someone in the context of acute withdrawal would kill themselves, that certainly could be real because it’s so excruciating.”

From the perspective of a pain patient and a former nonprofit board member, I want to set the record straight about Kolodny’s alleged “hoax.” Yes, addiction is a serious issue. Under-treatment of chronic pain is also a serious issue. Any mistreatment of people with chronic care challenges is an issue.

The healthcare system in the U.S. is working as it was designed and needs to be thrown out. We are all individuals and should be treated by the providers of our choosing to get the care that we need — not as the healthcare system dictates. Not every provider is great, not every patient is great, and no treatment works for everyone. 

In America, we live in a “free” society. I believe we should be able to choose our own care and moral stance. But I wonder why Kolodny believes his moral stance should supersede what a provider and patient feel is best, whether it’s addiction treatment, pain management or any particular choice of care.

We should have full access to whatever we are willing to do to our own bodies. I have said many times over the years that I do not want to be a guinea pig anymore. I work hard to manage my pain levels, my surroundings, my energy pennies, and the people around me.

‘Advocates With Industry Ties’

Kolodny claims that many “opioid advocates” have industry ties and manufactured a false narrative about patient suicides in a backlash against the CDC guideline.

As a patient advocate who has been working with nonprofits for almost 20 years, I believe that the pharmaceutical industry should be giving money to the pain community to help us with tools and resources that make our lives better.

People think it’s easy for advocacy groups to get funding from Pharma, but that is not true, at least for the small funding that I was involved with. I know firsthand the many checks and balances that are needed before any grant money is provided. It did not matter if it was $100 or $10,000. Nonprofits have to account for it on their tax returns and through audits.

Since 2015, grant money from Pharma for iPain completely stopped, even the small amounts that we were getting. We went from completing over 200 grant applications a year, and getting less than 5 percent of them approved, down to a 0% success rate. There is nothing to report when you receive nothing, which is how it is going now for most patient advocacy organizations and support groups.

Receiving nothing from Pharma did not change our opinions or goals. We found other ways to accomplish them on a shoestring budget. I wish it was easier, but being hard does not stop the movement, because it is a matter of life or death in too many cases. Our work at iPain continued, because it was never about spreading whatever Pharma wanted. It was always about helping patients get individualized care. And all options, including opioids, should be on the table.  

Our work continued on a smaller scale and more creatively than if we had a large budget to get things done. At about the same time that our funding dried up, social media took off and it became easier to reach more people and actually be heard. We were still able to accomplish our goals, at less cost and with less funding.

I do not have the time, energy or space in this column to go into the many financial ties — disclosed and undisclosed — that Kolodny and PROP have with law firms involved in opioid litigation, which funded their efforts to take opioids away from patients. Good God, what is the point of him being so moral in his own eyes, that he does not let other people choose what is best for them?  

Patients losing access to treatment is real. So are patients dying or contemplating suicide. I receive emails and calls from them regularly, even since stepping down from iPain.

The first patient I lost due to being cut off from medication was in 2012. She was one of my best friends at the time. I talked to her often. She was on a medication that was helping. The provider cut her off and put her on a different drug. Neither were opioids. She was stable and doing well with the first medication, but not on the second one. My friend decided that jumping out of a 10-story window to her death would be better than not having the medication that was giving her more quality of life.

Kolodny says someone in acute withdrawal might kill themselves because it is so excruciating. Yes, Dr. Kolodny, withdrawal is hard and you are forcing it on people who are already in pain, who did not need or ask for your opinion. That is the real hoax.

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and best-selling author on pain topics. Barby has received over 25 awards for her advocacy efforts over the years. You can follow her at www.barbyingle.com