Over 75% of MS Patients Face Financial Hardship

By Pat Anson, PNN Editor

Over 75% of American adults with multiple sclerosis face financial toxicity or hardship that has forced them to cut spending on food, clothing and housing. Many have gone into debt or filed for bankruptcy, and over a third have delayed or stopped filling prescriptions because they can’t afford them.

The findings come from a survey of 243 multiple sclerosis (MS) patients conducted by the Harvey L. Neiman Health Policy Institute. The study is the first of its kind to evaluate how financial hardship is forcing MS patients to forego treatment and make drastic changes in their lifestyles and spending.

In recent years, the cost of prescriptions for many disease-modifying MS drugs has nearly tripled to about $76,000 a year. While insurance pays for most of it, many patients are overwhelmed by deductibles and other out-of-pocket expenses. The lifetime cost of treating MS in the United States is estimated at over $4 million per patient.

“Over the last 20 years, higher out-of-pocket costs for advanced imaging tests and increased cost sharing have caused the financial burdens on MS patients to escalate. Among medically bankrupt families, MS is associated with the highest total out of-pocket expenditures exceeding those of cancer patients,” said lead author Gelareh Sadigh, MD, an assistant radiology professor at Emory University School of Medicine.

“Our study results demonstrate the high prevalence of financial toxicity for MS patients and the resulting decisions patients make that impact their health care and lifestyle.”

More Debt, Less Spending

The findings, published in the Multiple Sclerosis Journal, show that over half of MS patients (56%) reported decreases in their income due to disability, unemployment or retirement. To make ends meet, many cut spending on food and clothing (35%) and leisure activities (50%) or withdrew money from their savings (40%) and retirement accounts (15%). Others went into debt by borrowing money (19%) or charging their credit cards (30%).

Over a third of MS patients decided to forego some type of medical care or treatment, such as not filling a prescription (16%), skipping doses (13.5%) or stopped taking medication (13%).

“These data underscore the need for shared decision-making and an awareness of patient financial strain when planning treatment strategies,” said co-author and Neiman Institute researcher Richard Duszak, MD, a professor and vice chair for health policy at Emory University. “In addition to the impact on adherence, financial toxicity was associated with significantly lower physical health-related quality of life, demonstrating the broad consequences of treatment costs for many MS patients.”

MS is a chronic and progressive disease that attacks the body’s central nervous system, causing pain, numbness, difficulty walking, paralysis, loss of vision and fatigue. Disease modifying therapy (DMT) reduces the frequency and severity of MS flare-ups, but many patients can’t afford the drugs.

A 2019 survey by the National Multiple Sclerosis Society found that 40% of MS patients who take a DMT drug altered or stopped taking their medication due to the high cost. According to Healthcare Bluebook, a 30-day supply of a brand name DMT like Gilenya costs about $8,845, or over $106,000 a year.

Criticism of the high cost of MS drugs is growing. Last year when the FDA approved a new MS medication called Vumerity, drug maker Biogen set its wholesale price at $88,000 a year. That brought a rebuke from the National MS Society, which released a statement that accused Biogen of price gouging.

FDA Targets Online Pharmacies for Selling Opioids

By Pat Anson, PNN Editor

The Food and Drug Administration is once again playing whack-a-mole with illegal online pharmacies, warning 17 website operators to stop selling unapproved or misbranded opioid medications to U.S. consumers, including some drugs offered for sale without a prescription.

In recent years, the FDA has sent hundreds of warning letters to online pharmacies for illegally selling opioids and other controlled substances. Many of the websites are located overseas and outside U.S. jurisdiction or they shut down and soon reappear under new domain names.

According to the Alliance for Safe Online Pharmacies, there are over 30,000 online pharmacies operating worldwide, with 20 new illegal pharmacy websites being launched every day.

“Those who illegally sell opioids online put consumers at risk and undermine the significant strides we have made to combat the opioid crisis,” said Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We remain committed to using all available tools to stop the illegal sale of opioids online to help protect consumers from these potentially dangerous products.”

The 17 warning letters were issued late last month. Most of the online pharmacies appear to have been shut down or blocked, although some are still operating.

RxEasyMeds, for example, continues to sell an opioid medication called “Nalbin” that is “used to treat moderate to severe pain associated with acute and chronic medical disorders.”

Nalbin is produced by a drug company based in Islamabad, Pakistan called Global Pharmaceuticals.

The FDA warning letter to RxEasyMeds – which is located in China -- says Nalbin is not approved for sale in the U.S. and does not have an adequate warning label.  

“Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight, and drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether,” the FDA letter warns. “Accordingly, FDA requests that you immediately cease offering violative drugs for sale to U.S. consumers.  This is critical to shielding the American public from harm.”

In addition to Nalbin, RxEasyMeds advertises codeine, morphine, tramadol, oxycodone and other controlled substances, which are all apparently available without a prescription.

In June, the FDA launched a pilot program to put more teeth into efforts to stop the illegal sale of opioids online. Under the program, the FDA will notify three internet registries when a warning letter is sent to an online pharmacy. The registries could then block or suspend the website domains, which would effectively take them offline.

Study Finds Acetaminophen Makes People More Likely to Take Risks

By Pat Anson, PNN Editor

We’ve learned some weird things about acetaminophen in recent years. The pain reliever not only helps treat headaches and fevers; it also appears to dull human emotions and have other psychological effects.

A new study at The Ohio State University suggests that acetaminophen could even make you more likely to go sky diving or bungee jumping off a tall bridge.

"Acetaminophen seems to make people feel less negative emotion when they consider risky activities - they just don't feel as scared," says co-author Baldwin Way, PhD, an associate professor of psychology at OSU.

Way and his colleagues enrolled 189 college students in the study, giving them either 1,000 mg of acetaminophen (the recommended dose for a headache) or a placebo that looked the same. Participants were then asked to rate on a scale of 1 to 7 how risky they thought various activities would be.

Students who took acetaminophen were more likely to rate bungee jumping, taking a skydiving class, and walking home late at night in an unsafe part of town as less risky than those who took the placebo. They were also less likely to view speaking up about an unpopular issue at work and playing in a high-stakes poker game as risky.

In short, the study found that acetaminophen makes people more likely to take risks, which is not inconsequential when you consider that about 50 million Americans take acetaminophen every week. The pain reliever is the active ingredient in Tylenol, Excedrin and hundreds of other pain medications, as well as cough, cold and flu remedies.

The OSU study, published in the journal Social Cognitive and Affective Neuroscience, was funded by a $500,000 grant from the National Science Foundation, a federal agency. It adds to a growing body of research that found acetaminophen and other over-the-counter pain relievers have psychological effects on humans.

“With nearly 25 percent of the population in the U.S. taking acetaminophen each week, reduced risk perceptions and increased risk-taking could have important effects on society,” said Way. "We really need more research on the effects of acetaminophen and other over-the-counter drugs on the choices and risks we take.”

Burst Balloons

To test their theory, OSU researchers conducted an experiment to see if volunteers would take more risks while inflating a virtual balloon on a computer screen. Participants clicked a button on a computer to inflate the balloon, earning virtual money as a reward each time they did.

"As you're pumping the balloon, it is getting bigger and bigger on your computer screen, and you're earning more money with each pump," Way explained. "But as it gets bigger you have this decision to make: Should I keep pumping and see if I can make more money, knowing that if it bursts, I lose the money I had made with that balloon?"

People who took acetaminophen were more likely to keep on pumping and had more burst balloons.

"If you're risk-averse, you may pump a few times and then decide to cash out because you don't want the balloon to burst and lose your money," said Way. "But for those who are on acetaminophen, as the balloon gets bigger, we believe they have less anxiety and less negative emotion about how big the balloon is getting and the possibility of it bursting."

Previous research at OSU found that acetaminophen seems to dampen human emotions. Student volunteers who took acetaminophen had fewer emotional highs and lows, and felt less empathy for the physical and emotional pain of others. Other studies have linked acetaminophen to hyperactivity and behavior problems in children.

It’s not just acetaminophen. A 2018 review of studies found that ibuprofen and other over-the-counter pain relievers can also dull your emotions and cognitive senses.

A recent study of calls to U.S. poison control centers found a significant increase in suicide calls involving acetaminophen, ibuprofen and other OTC analgesics.

Excessive use of acetaminophen -- also known as paracetamol – can lead to liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

DEA Proposes Cuts in Opioid Supply for Fifth Consecutive Year

By Pat Anson, PNN Editor

For the fifth year in a row, the U.S. Drug Enforcement Administration is proposing significant cuts in the supply of hydrocodone, oxycodone and several other opioid pain medications classified as Schedule II controlled substances.

The cuts are partly based on a prediction by the Food and Drug Administration that medical need for the drugs will decline by over a third in 2021.

In a notice published Tuesday in the Federal Register, the DEA proposes to reduce production quotas for hydrocodone by 9 percent and oxycodone by 13 percent in 2021. The supply of hydromorphone would be reduced by nearly 20% and fentanyl by 29% next year.  

The DEA first proposed cuts in the supply of opioids during the Obama administration and the trend has accelerated under President Trump. If approved, the 2021 production quotas would amount to a 53% reduction in the supply of both hydrocodone and oxycodone since 2017.

DEA consulted with the FDA, CDC and the Centers for Medicare & Medicaid Services (CMS) before making its recommendations. The key analysis came from the FDA, which provides DEA with annual estimates of medical usage for controlled substances like opioids.

“FDA's predicted levels of medical need for the United States was expected to decline on average 36.52 percent for calendar year 2021. These declines were expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, codeine, and morphine,” the DEA said.

The FDA’s analysis, however, came before COVID-19 infections became widespread in the United States. That led to an increase in demand for injectable opioids used to treat seriously ill coronavirus patients on ventilators.

Faced with growing shortages of those drugs, the DEA issued an emergency order in April raising production quotas for injectable pain medications. Many of those drugs, such as injectable fentanyl and hydromorphone, are still listed on an FDA database of drug shortages.     

DEA said its production quotas for 2021 reflect an “anticipated increase in demand for opioids used to treat patients with COVID-19.”

“Despite this public health emergency, DEA remains focused on the challenges presented by opioid addiction and its effect on the health and wellbeing of the millions of Americans and their families who have become dependent upon or addicted to them. The potential for addiction and misuse exists in every community and remains a pressing health issue with significant social and economic implications,” the agency said.

As PNN has reported, prescription opioids play only a small role in the U.S. opioid epidemic. A new CDC report estimates that nearly 85% of drug overdoses in the first six months of 2019 involved illicit fentanyl, heroin and other street drugs. Prescription opioids were linked to about 20% of overdoses.

In addition to reducing the supply of opioids, the DEA is proposing a significant cut in the production quota for marijuana, which is still classified as a Schedule I controlled substance. To accommodate increased demand for marijuana research, the DEA raised the 2020 quota for marijuana to 3,200 kilograms. Those gains would be reversed in 2021, with production quotas for marijuana and marijuana extracts being reduced to 1,700 kilograms.

Public comments will be accepted on the DEA’s proposed production quotas until October 1, 2020. Comments can be made by clicking here.

Nearly 85% of U.S. Overdose Deaths Linked to Street Drugs

By Pat Anson, PNN Editor

A new report by the Centers for Disease Control and Prevention shows that the vast majority of drug overdose deaths in the United States involve illicit fentanyl and other street drugs.  

The study, reported in the CDC’s Morbidity and Mortality Weekly Report, analyzed data from 24 states and the District of Columbia enrolled in the State Unintentional Drug Overdose Reporting System (SUDORS) from January to June, 2019. SUDORS captures detailed information from toxicology reports and death scene investigations, and is considered more reliable than overdose data gathered from death certificates.

Among the 16,236 overdose deaths reported by SUDOR during the study period, illicitly manufactured fentanyl (IMF), heroin, cocaine or methamphetamine were involved 83.8% of deaths, either alone or in combination with other drugs. Nearly half of those deaths involved two or more illicit drugs.

About one in five overdoses involved prescription opioids such as hydrocodone, oxycodone, morphine and buprenorphine. The study did not indicate whether the medication was obtained legally or if it was borrowed, stolen or purchased illicitly. What is clear, however, is that street drugs are the primary driver of the U.S. overdose crisis.

% RATE OF DRUGS INVOLVED IN FATAL OVERDOSES (JAN-JUNE, 2019)

SOURCE: CDC

“The finding of this report that nearly 85% of overdose deaths involved IMFs, heroin, cocaine, or methamphetamine reflects rapid and continuing increases in the supply of IMFs and methamphetamine, coupled with illicit co-use of opioids and stimulants,” researchers reported.

More than two thirds (68.5%) of overdose victims were male, and over half (53.3%) were 25 to 44 years of age; demographics that don’t fit the profile of most chronic pain patients, who are generally older and female.

NBER Report Blames Rx Opioids

The new CDC report is at odds with a working paper recently published by the National Bureau of Economic Research (NBER), a non-profit, private think tank. The NBER report largely blames prescription opioids for the U.S. overdose epidemic – not street drugs or so-called “deaths of despair” caused by rising social isolation and economic distress.  

“People have blamed all sorts of things, heroin from Mexico and fentanyl from China and economic decline and so on and so forth,” co-author Janet Currie, PhD, a professor of economics at Princeton University, told Yahoo Finance. “But really the issue is that a whole lot of people got addicted because they were prescribed pain medications which aren’t prescribed in the same way in other countries.”

Currie and co-author Hannes Schwandt, PhD, an economics professor at Northwestern University, say pharmaceutical companies aggressively marketed opioids at a time when doctors were being encouraged to treat pain as “the fifth vital sign.”

“We argue that the development and marketing of a new generation of prescription opioids sparked the epidemic and that provider behavior is still helping to drive it,” the NBER report states. “Prior to the marketing push, most doctors had believed that opioids were too addictive and dangerous for anyone except terminally ill patients. Aggressive marketing by pharmaceutical companies changed those perceptions: Sales of opioid pain killers quadrupled between 1999 and 2013, fueling the rise in overdose deaths.”

What Curry and Schwandt fail to mention is that opioid prescriptions have fallen by nearly 40% since 2013. And their report only briefly mentions the rising toll taken by illicit fentanyl and other street drugs.

Fatal drug overdoses fell in 2018, for the first time in nearly 30 years, but many signs indicate they are rising again and that the COVID-19 pandemic is making the crisis worse in the U.S. and Canada.   

Canada’s Chief Public Health Officer recently warned the pandemic is fueling another surge in drug deaths in Canada.

“Tragically, in many regions of the country, the COVID-19 pandemic is contributing to an increase in drug-related overdoses and deaths,” Dr. Theresa Tam said in a statement. “There are indications that the street drug supply is growing more unpredictable and toxic in some parts of the country, as previous supply chains have been disrupted by travel restrictions and border measures. Public health measures designed to reduce the impact of COVID-19 may increase isolation, stress and anxiety as well as put a strain on the supports for persons who use drugs.”

A Pained Life: Don’t Throw Out the Bathwater

By Carol Levy, PNN Columnist

In 1976, my trigeminal neuralgia started. In those days, the environment regarding chronic pain was very different. My doctor had only one agenda: He wanted to stop or reduce my constant debilitating and disabling pain.

He couldn’t cure me, so he ordered opioid pain medication. When one opioid didn’t work, he tried another; Darvon, Percocet, Percodan, Demerol. So many I can’t recall them all. When none helped, he prescribed an 8-ounce bottle of opium.

The first pharmacist who saw the opium prescription shook his head. “Sorry. We don't carry it,” he said. The next pharmacy did. “Have a seat. It'll just be a few minutes,” the pharmacist said.

I wasn't looked at askance. No questions were asked about my doctor or diagnosis. I wasn’t warned: “This is a very strong drug. You need to be careful. You could become addicted.”

They trusted that my doctor knew what he was doing. They trusted me to be a responsible patient. I doubt it ever entered the pharmacist’s mind that I might be a drug seeker or abuser.

Now the tables have totally turned. Many of us get questioned by pharmacists. And some of our doctors have stopped writing opioid prescriptions. They should be cautious, right? Because opioids are addictive, you can become dependent or have other bad side effects. And they can be used illegally.

The same is true for steroids. Yet there seem to be no politicians, physicians or groups with an agenda that are working to scare the public about steroids or trying to get doctors to stop “overprescribing” them.  

When steroids first came out there were many, many horror stories about them. The 1956 film Bigger Than Life was about a school teacher (James Mason) taking corticosteroids. They helped his pain from an autoimmune disorder, but he soon became hyper-manic and ultimately psychotic, even trying to murder his son.

His doctor reduced the dosage, but because steroids helped his pain, the teacher continued to take more than prescribed. He even goes to another town, impersonates a doctor, and writes a fake prescription to obtain more of the pills.

Sound familiar?

The movie was a caricature of the potential risks of steroids, which include dependency and addiction. Opioids have the same risks, but most patients with chronic pain take them responsibly, as most on steroids do, and they do not become addicted, try to obtain them fraudulently or go off the deep end.

There will always be bad actors who will be irresponsible, but users of any medication should not be demonized because of a few bad apples. Steroids are easily obtained and the patients who use them are not seen as potential felons. And why would they? For most patients, steroids can be very helpful.

Those who can still get opioids for their pain are often seen as potential miscreants. Yet studies also show that for most patients, opioids do help.

You don’t throw out the baby with the bathwater. You don’t create guidelines scaring doctors into not writing steroid prescriptions because a small percentage of people will misuse or abuse them.

The medical community and the government need to stop throwing out the bathwater. When they refuse to write prescriptions for opioids that have helped patients, the side effect — intentional or not — is to throw us away, too.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

Lawyers May Not Expand Lawsuits Against Pharmacy Chains

By Pat Anson, Editor, PNN Editor

Lawyers involved in class action lawsuits that allege pain patients were discriminated against by three major pharmacy chains are being tight-lipped about whether the lawsuits may be expanded to include additional plaintiffs and pharmacies.

The lawsuits were filed earlier this month in California and Rhode Island against CVS, Walgreens and Costco on behalf of two women who say the pharmacies refused to fill their prescriptions for opioid pain medication.

At least six different law firms around the country are handling the cases. They’ve set up a website called Seeking Justice for Pain Patients, which invites other patients to participate in the lawsuits by sharing their personal information and experiences at pharmacies. It’s not yet clear how the information will be used or if the cases will be expanded.

“Pain patients have been contacting us in response to the lawsuits. The overall response has been very positive and happy that some action is being taken,” Robert Redfearn, a Louisiana attorney, said in an email to PNN. “Though there are no plans to do so at this time, additional individual named plaintiffs could possibly be added, but if a national class is certified, it should not be necessary.” 

Other lawyers involved in the lawsuits did not respond to requests for comment.

Redfearn represents Susan Smith, a 43-year old mother from Castro Valley, California who lives with severe chronic migraines. The only medications that give her relief from head pain are opioids. Smith says pharmacists at Walgreens and Costco refused to fill her opioid prescriptions and publicly shamed her.

“After being harassed by pharmacists [and] pharmacy staff for a number of years — being laughed at, being called names in front of my child — I really couldn’t take it anymore,” Smith told the San Francisco Examiner. “It has been really stressful, demoralizing, not to mention discriminating. On top of that, they were making it really hard for me to live a pain-free life.”

‘Find a New Pharmacy’

“There has to be a change,” says Edith Fuog, a 48-year old Tampa, Florida mother who filed the lawsuit against CVS. Fuog has lived for many years with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions.

“People need to understand what is happening. Everybody in their life is going to be a pain patient at one point or another, whether it’s an accident, becoming elderly, a disease or cancer. If this is happening to people who have chronic pain, the people who are just coming in with acute pain are never going to be treated.”

Fuog told PNN she had no trouble getting her opioid prescriptions filled at a CVS pharmacy until the CDC’s controversial opioid prescribing guideline was released in 2016.

“As soon as those guidelines came out, my life changed. The manager pulled me aside and said, ‘Look, I’m not going to be able to fill these anymore. I suggest you find a new pharmacy.’” said Fuog, who then went to other CVS pharmacies in the Tampa area and was repeatedly turned down.

“They all said, ‘We’ll be happy to fill all your other meds, but we will not fill the opioids.’ And I said, ‘I take 13 other medications. Why would I come here then?’”

EDITH FUOG

Fuog eventually found a small neighborhood pharmacy that was willing to fill all of her prescriptions. She also found a lawyer to file the class action lawsuit against CVS. If her case is successful, Fuog anticipates making only a few thousand dollars in damages.

“It’s not like I’m going to make a bunch of money. The decision could come down for a hundred million dollars, but that’s for the class and the attorneys. I’ll get a ‘rep fee” being the class rep. That’s it. I don’t get anything for my damages or the stress I go through, and the fact I have severe anxiety because of this,” she said.

Fuog says she will only settle out-of-court if CVS adopts a written public policy that makes clear to its pharmacists that they should fill all legitimate prescriptions for opioids.

“My goal in this is to make change that affects the most amount of people with chronic pain. If I can get them a lot of money, I’m going to do it. Why wouldn’t I? To me, these companies deserve to pay all these people money for what they’ve been through,” she said.

Costco, CVS and Walgreens did not respond to requests for comment.  CVS, Walgreens and other large pharmacy chains have been named in lawsuits alleging they helped fuel the opioid epidemic by selling millions of pills in small communities. They’ve also been fined hundreds of millions of dollars for violating federal rules for dispensing controlled substances.

Most Americans Know Little About Opioid Medication

By Pat Anson, PNN Editor

Before the Covid-19 pandemic dominated the nation’s headlines, the opioid crisis was widely considered the most serious public health threat in the United States, with much of the news coverage and public attitudes focused on the role played by opioid pain medication.

A 2017 Pew Research survey found that 3 out of 4 Americans viewed prescription drug abuse as a serious public health problem. Another survey that year found that nearly half of Americans had a family member or close friend addicted to drugs.

It turns out most Americans know surprisingly little about opioid medication. A recent survey of over 1,000 U.S. adults by DrFirst, a healthcare technology company, found a significant lack of understanding about opioids.      

While more than three-quarters (76%) of respondents think they know whether or not they were prescribed an opioid, only 22% could correctly identify seven commonly prescribed opioid painkillers. The following medications were misidentified as not containing opioids:

• Tramadol (44%)

• Hydromorphone (32%)

• Morphine sulfate (27%)

• Methadone (27%)

• Hydrocodone (23%)

• Fentanyl (22%)

• Oxycodone (15%)

Many respondents also misidentified non-opioid medications. Nearly three quarters (73%) thought oxytocin was an opioid (apparently confusing it with oxycodone), even though it’s a hormone that helps women bond with their newborn babies.

Other medications that were often misidentified as opioids:    

• Oxymetolazine (56%)

• Trazodone (46%)

• Omeprazole (33%)

• Hydrocortisone (31%)

• Hyaluronic acid (23%)

“American consumers have some significant and dangerous misunderstandings about which medicines contain opioids,” said Colin Banas, MD, vice-president of clinical products for DrFirst. “This is concerning because patients need to know if they are prescribed an opioid so they can use and store it safely. It should be a wake-up call to physicians and pharmacists, who should not assume their patients know this information.”

One out of five survey respondents said they had been prescribed an opioid in the past year, but 21% of them said they didn’t get the prescription filled.

Over three-quarters of those who did get their prescriptions filled did not keep their opioids in a locked cabinet, as some safety experts recommend. Most kept the drugs within easy reach.

• In a locked cabinet (23%)

• On a nightstand table (14%)

• Kitchen table (13%)

• Bathroom cabinet (13%)

• Purse or backpack (10%)

• Bathroom counter (10%)

The DrFirst survey of 1,002 American adults was conducted online by Propeller Insights from June 16 to June 19, 2020.

Only 2% of British Columbia Overdoses Linked to Prescription Opioids

By Pat Anson, PNN Editor

A new analysis of fatal opioid overdoses in British Columbia found that only about 2% of the deaths were caused by prescription opioids alone. The other overdoses mainly involved illicit fentanyl and other street drugs or a combination of illicit drugs and other medications, which were often not prescribed.

“Our data show a high prevalence of nonprescribed fentanyl and stimulants, and a low prevalence of prescribed opioids detected on toxicology in people who died from illicit drug overdose. These results suggest that strategies to address the current overdose crisis in Canada must do much more than target deprescribing of opioids,” researchers reported in the Canadian Medical Association Journal (CMAJ).

Vancouver, British Columbia was the first major North American city to be hit by a wave of overdoses involving illicit fentanyl, a potent synthetic opioid. A public health emergency was declared in BC in 2016 and strict guidelines were released to limit opioid prescribing. Although prescriptions dropped dramatically, fatal overdoses in BC continued to rise.

Researchers looked at 1,789 fatal overdoses in BC from 2015 to 2017 for which toxicology reports were available and found that 85% of them involved an opioid. Of those, only 2.4% of the deaths were linked to opioid medication alone. Another 7.8% of cases involved a combination of prescribed or non-prescribed opioids.

The findings are similar to a 2019 study of opioid overdoses in Massachusetts, which found that only 1.3% of the people who died had an active prescription for opioid medication.   

“Pain patients and their medications have never been responsible for overdose deaths – not then or now. Will the anti-opiate zealots, with all their data-dredged studies be taken to task for all the unnecessary suffering, disability, and premature deaths they have contributed to within the Canadian pain population?” asked Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, a patient advocacy group.

“The ‘prohibition’ approach that has wrongly been applied for years that focused on reducing access to pharmaceutical products directly contributed to exposure to higher risk illicit substances, which put people at risk of overdose.”

Most Overdoses Linked to Illicit Fentanyl

Researchers say efforts to reduce opioid prescribing in Canada were “insufficient to address the current overdose crisis” because street drugs are involved in the vast majority of deaths. They also warned against the forced tapering of patients on opioid pain medication.

“The risk of harms from these medications must be balanced with the potential harms of nonconsensual discontinuation of opioids for long-term users, including increased pain, risk of suicide and risk of transition to the toxic illicit drug supply,” wrote lead author Alexis Crabtree, MD, resident physician in Public Health at the University of British Columbia.  

Crabtree and her colleagues found that most overdoses involved a street drug, with fentanyl or fentanyl analogues linked to nearly 8 out of 10 overdose deaths. Many of the deaths involved multiple substances, including medications such as stimulants, anti-depressants, benzodiazepines, antipsychotics and gabapentinoids, which were often not prescribed to the victim.   

Over 7% of the overdoses involved methadone or buprenorphine (Suboxone), opioids that are used to treat addiction. About a third of the people who died had a diagnosis of substance use disorder in the year before their overdose.

In a commentary also published in CMAJ, a leading public health expert said it was time to decriminalize drugs and offer a “safe supply” to illicit drug users.

“Unless there is a radical change in our approach to the epidemic, overdose deaths will continue unabated. It is time to scale up safe supply and decriminalize drug use.”

— Dr. Mark Tyndall

“Unless there is a radical change in our approach to the epidemic, overdose deaths will continue unabated. It is time to scale up safe supply and decriminalize drug use,” wrote Mark Tyndall, MD, Executive Director of BC Centre for Disease Control and a professor at the School of Population and Public Health, University of British Columbia.

Tyndall says blaming the opioid crisis on excess prescribing by doctors and the unethical marketing of opioids by pharmaceutical companies fails to address the reasons people abuse drugs in the first place.

“While having a cheap and ready supply of opioid drugs does allow for misuse and addiction, this narrative fails to acknowledge that drug use is largely demand-driven by people seeking to self-medicate to deal with trauma, physical pain, emotional pain, isolation, mental illness and a range of other personal challenges and these are the people overdosing,” Tyndall wrote.

(Update: Canada’s Chief Public Health Officer, Dr. Theresa Tam, issued a statement August 26 saying the COVID-19 pandemic is contributing to an increase in drug overdoses and deaths across Canada.

“There are indications that the street drug supply is growing more unpredictable and toxic in some parts of the country, as previous supply chains have been disrupted by travel restrictions and border measures. Public health measures designed to reduce the impact of COVID-19 may increase isolation, stress and anxiety as well as put a strain on the supports for persons who use drugs,” Tam said.

“For the third consecutive month this year, the number of drug overdose deaths recorded in British Columbia has exceeded 170. These deaths represent a 136% increase over the number of deaths recorded in July 2019. There are news reports of an increase in overdoses in other communities across the country.” )

New Hampshire Law Protects Patient Access to Rx Opioids

By Pat Anson PNN Editor

Patient advocates around the country are looking with keen interest at a new law in New Hampshire that stipulates chronic pain patients should have access to opioid medication if it improves their physical function and quality of life.

HB 1639 was signed into law by Gov. Chris Sununu late last month. It amends state law to add some key provisions that protect the rights of both pain patients and their doctors.

Under the law, physicians and pharmacists are required to consider the “individualized needs” of pain patients, treat them with dignity, and ensure that they are “not unduly denied the medications needed to treat their conditions."   

Since the CDC’s controversial opioid prescribing guideline was released in 2016, dozens of states have adopted laws and policies that restrict the prescribing of opioids to the CDC’s recommended daily limit of 90 MME (Morphine Milligram Equivalent). Doctors who exceed that dose often come under the scrutiny of law enforcement and some pharmacists have stopped filling their prescriptions. As a result, millions of patients have been tapered to lower doses or cut off from opioids altogether, causing withdrawal, poorly treated pain and increased disability.  

Under the New Hampshire law, “all decisions” regarding treatment are to be made by the treating practitioner, who is required to treat chronic pain “without fear of reprimand or discipline.” Doctors in the state are also allowed to exceed the MME limit, provided the dose is “the lowest amount necessary to control pain” and there are no signs of a patient abusing their opioid medication.

“Ordering, prescribing, dispensing, administering, or paying for controlled substances, including opioid analgesics, shall not in any way be pre-determined by specific Morphine Milligram Equivalent (MME) guidelines.

For those patients who experience chronic illness or injury and resulting chronic pain who are on a managed and monitored regimen of opioid analgesic treatment and have increased functionality and quality of life as a result of said treatment, treatment shall be continued if there remains no indication of misuse or diversion.”

Importantly, the new law broadly defines chronic pain to include any pain that is intractable, high impact, episodic or relapsing — meaning the pain doesn’t have to be continuous.

“This innovative new law is historic in that it states that controlled substances, including opioids, can't be pre-determined by specific morphine milligram equivalents,” says Dr. Forest Tennant, a retired pain management specialist in California. “The law specifically states that patients can't be unduly denied the medications needed to treat their conditions. This point can't be over-emphasized.”

Another provision of the law requires that a diagnosis of chronic pain made by a physician anywhere in the U.S. that is supported by written documentation should be considered adequate proof that a patient has chronic pain. That part of the law is intended to make it easier for out-of-state pain patients to get treatment in New Hampshire.      

The law is the result of two years of lobbying by a small group of patient advocates known as the New Hampshire Pain Collaborative, which worked closely with state Sens. John Reagan and Tom Sherman in drafting the legislation. Key provisions eventually became part of the healthcare omnibus bill that won bipartisan support in the New Hampshire Senate and House of Representatives, and was signed into law by Governor Sununu.

Bill Murphy, a member of the Pain Collaborative, made this video to help other patients and advocates create similar legislation in their states:

“I would like to say a big congrats to all who worked on that project! Isn't it amazing what you can accomplish when you all work together?” said Donna Corley, director of the Arachnoiditis Society for Awareness and Prevention (ASAP), a patient advocacy group.

“Many patients aren't aware of just how important this bill truly is. This should have been enacted and should be implemented in every state in the United States to help secure safe, and reliable pain care treatment for all patients who suffer chronic pain in the United States. To be able to have diagnoses from other states and it be accepted by your doctor is phenomenal as well.”

“All concerned parties need to salute and follow suit of the New Hampshire law,” Dr. Tennant said in an email to PNN. “The tragedy of the recent over-reach to control opioid abuse, diversion, and overdoses has caused immense suffering for legitimate, chronic pain patients, an epidemic of suicides among deprived pain patients, and the forced retirement of many worthy physicians (including yours truly). All this ugliness would have been prevented with the New Hampshire law.”

According to the CDC, New Hampshire physicians wrote 46.1 opioid prescriptions for every 100 persons in 2018. That’s well below that national average of 51.4 prescriptions. That same year, 412 people died of drug overdoses in New Hampshire, the vast majority of them involving synthetic opioids such as illicit fentanyl and other street drugs.  Only 43 of those 412 deaths involved a prescription opioid.  

Guideline Recommends Topical Pain Relievers for Muscle Aches and Joint Sprains

By Pat Anson, PNN Editor

A new guideline for primary care physicians recommends against the use of opioid medication in treating short-term, acute pain caused by muscle aches, joint sprains and other musculoskeletal injuries that don’t involve the lower back.

The joint guideline by the American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP) – which collectively represent nearly 300,000 doctors in the U.S. – recommends using topical pain creams and gels containing non-steroidal anti-inflammatory drugs (NSAIDs) as first line therapy. Other recommended treatments include oral NSAIDs, acetaminophen, specific acupressure, or transcutaneous nerve stimulation (TENS).

Musculoskeletal injuries, such as ankle, neck and knee injuries, are usually treated in outpatient settings. In 2010, they accounted for over 65 million healthcare visits in the U.S., with the annual cost of treating them estimated at over $176 billion.

"As a physician, these types of injuries and associated pain are common, and we need to address them with the best treatments available for the patient. The evidence shows that there are quality treatments available for pain caused by acute musculoskeletal injuries that do not include the use of opioids," said Jacqueline Fincher, MD, president of ACP.

Opioids, including tramadol, are only recommended in cases of severe injury or intolerance to first-line therapies. While effective in treating pain, the guideline warns that a “substantial proportion” of patients given opioids for acute pain wind up taking them long-term.   

The new guideline, published in the Annals of Internal Medicine, recommends topical NSAIDs, with or without menthol, as the first-line therapy for acute pain from non-low back, musculoskeletal injuries. Topical NSAIDs were rated the most effective for pain reduction, physical function, treatment satisfaction and symptom relief.

Treatments found to be ineffective for acute musculoskeletal pain include ultrasound therapy, non-specific acupressure, exercise and laser therapy.

"This guideline is not intended to provide a one-size-fits-all approach to managing non-low back pain," said Gary LeRoy, MD, president of AAFP. "Our main objective was to provide a sound and transparent framework to guide family physicians in shared decision making with patients."

Guideline Based on Canadian Research

Interestingly, the guideline for American doctors is based on reviews of over 200 clinical studies by Canadian researchers at McMaster University in Ontario, who developed Canada’s opioid prescribing guideline. The Canadian guideline, which recommends against the use of opioids as a first-line treatment, is modeled after the CDC’s controversial 2016 opioid guideline.  

After reviewing data from over 13 million U.S. insurance claims, McMaster researchers estimated the risk of prolonged opioid use after a prescription for acute pain was 27% for “high risk” patients and 6% for the general population.

"Opioids are frequently prescribed for acute musculoskeletal injuries and may result in long-term use and consequent harms," said John Riva, a doctor of chiropractic and assistant clinical professor in the Department of Family Medicine at McMaster. "Potentially important targets to reduce rates of persistent opioid use are avoiding prescribing opioids for these types of injuries to patients with past or current substance use disorder and, when prescribed, restricting duration to seven days or less and to lower doses."

Riva and his colleagues said patients are also at higher risk of long-term use if they have a history of sleep disorders, suicide attempts or self-injury, lower socioeconomic status, higher household income, rural residency, lower education level, disability, being injured in a motor vehicle accident, and being a Medicaid recipient.

A history of alcohol abuse, psychosis, episodic mood disorders, obesity, and not working full-time “were consistently not associated with prolonged opioid use.”

The McMaster research, also published in the Annals of Internal Medicine, was funded by the National Safety Council (NSC), a non-profit advocacy group in the U.S. supported by major corporations and insurers. The NSC has long argued against the use of opioid pain relievers, saying they “do not kill pain, they kill people.”

Study Finds Low Risk of Rx Opioid Abuse Among Young People

By Pat Anson, PNN Editor

The stories are heartbreaking. A young man gets a prescription for opioid pain medication and quickly becomes addicted.

“I lost everything. I had to leave school, and stop playing sports in college. I started to watch my life slip away. These drugs are addictive. One prescription can be all it takes to lose everything,” says Mike.

A mother loses her son to an overdose.

“My son… was 20 years old when he was prescribed opioids,” says Ann Marie. “It took him five days to get addicted.”

These are some of the real-life stories being told in a CDC awareness campaign that warns against the use of prescription opioids. “It only takes a little to lose a lot,” is the theme in a series of CDC videos, billboards and online ads.

The stories are sad, but the widespread belief that adolescents and young adults can quickly become addicted to prescription opioids is not accurate for the vast majority of young people, according to a large new study published in JAMA Pediatrics.

Researchers at Indiana University looked at a database of over 77,000 young people in Sweden between the ages of 13 and 29 who were prescribed opioids for the first time. They were compared to a control group that was given non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief. Both groups had no previous signs of substance abuse.

Only 4.6% of those prescribed an opioid developed a substance use disorder or other substance-related issue, such as an overdose or criminal conviction within five years of being prescribed.  That compared to 2.4% of those in the control group.

"By using several rigorous research designs, we found that there was not a huge difference -- in fact, the difference was smaller than some previous research has found,” said Patrick Quinn, PhD, an assistant professor at the IU School of Public Health-Bloomington. “But the study still shows that even a first opioid prescription may lead to some risk."

Interestingly, young people given oxycodone were at no greater risk of developing a substance abuse problem than those given “weaker” opioids such as codeine or tramadol.

Quinn says further research is needed to determine how much substance abuse risk is caused by opioid medication alone and how much is related to other issues, such as mental health, genetics and environmental factors.

"We need to have a good understanding of what those risks might be in order for patients and doctors to make informed decisions," said Quinn. "Our findings highlight the importance of screening for substance use disorders and other mental health conditions among patients with pain, including those receiving opioid therapy."

A 2018 study of young people given opioids after their wisdom teeth were removed also found the risk of long-term use low. The study of over 70,000 teens and young adults found that only 1.3% were still being prescribed opioids months after their initial prescription by a dentist.  

Pharmacies Sued for Discrimination Against Pain Patients

By Pat Anson, PNN Editor

National class action lawsuits have been filed against three of the nation’s largest pharmacy chains for discriminating against pain patients trying to fill legitimate prescriptions for opioid medication. 

Class action complaints against Walgreens, Costco and CVS Pharmacy were filed in California and Rhode Island on behalf of two women seeking legal relief that will allow them to get their opioid prescriptions filled without delays or restrictions, and without the fear that their prescriptions will be denied. 

Edith Fuog, a 48-year old Florida woman and breast cancer survivor, lives with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions. Fuog’s lawsuit alleges that since 2017, CVS pharmacies have refused to fill her prescriptions for opioid medication in violation of the American with Disabilities Act (ADA), the Rehabilitation Act of 1973 and the anti-discrimination provisions of the Affordable Care Act.  Her complaint was filed in Rhode Island, where CVS has its corporate headquarters.

43-year old Susan Smith of Castro Valley, California, filed a similar class action against Walgreens and Costco in the Northern District of California. Smith suffers from Mesial Temporal Lobe Sclerosis, which resulted in scar tissue in her brain that causes severe chronic migraines. The only medication that gives Smith relief from headache pain are opioids.  She alleges that Walgreens and Costco pharmacies refused to fill her opioid prescriptions in violation of federal law.

"Many Americans are unaware of the difficulties chronic pain patients have getting pharmacies to fill their lawfully-obtained opioid prescriptions. It is not only a crisis for Edith and Susan, but for millions of Americans due to the backlash caused in part by the national publicity concerning opioid abuse,” said Scott Hirsch, a Florida lawyer who is one of several lead attorneys handling the cases.

“These lawsuits seek to allow the millions of chronic pain patients to obtain their legitimate opioid prescriptions without being discriminated against, harassed, denied, or embarrassed.  It will hopefully improve their quality of life and save many lives in the process."

Pain patients in the U.S. have complained for years about pharmacists refusing to fill their opioid prescriptions or reducing them to lower doses. It’s also not uncommon for patients to encounter delays and excuses, such as a pharmacy claiming it was out of stock of a particular medication. The California and Rhode Island cases are believed to be the first class action lawsuits to address the problem.

“I have always thought that this is one of the better potential legal avenues for an ADA action regarding prescription opioids.  It is a violation for any person with a disability to be denied service by a place of public accommodation, and pharmacies are clearly covered as places of public accommodation under the ADA,” said Kate Nicholson, a patient advocate and civil rights lawyer who handled discrimination cases at the Department of Justice for over 20 years.

“Whether this will succeed will depend on a lot of intangibles such as the quality of the complaints, what is learned during discovery about any nationwide policies the pharmacy chains had in place, or, alternatively, repeated instances of fills for legitimate prescriptions being denied. Also, whether the court which hears it considers the refusal to fill prescriptions tantamount to a denial of service. I think it’s promising.”

Corporate Policies Profile Patients

While pharmacies have a legal right to refuse to fill prescriptions they consider suspicious or inappropriate, the lawsuits allege that CVS, Walgreens and Costco adopted corporate policies that encourage their pharmacists to profile patients as drug abusers and impose limits on opioid medication. The companies did not respond to a request for comment.

Walgreens adopted a “secret checklist” in 2013 that required its pharmacies to watch for red flags such as patients paying for opioid prescriptions in cash, seeking an early refill or taking an “excessive” number of pills. If anything was suspicious, pharmacists were instructed to “inform the patient that it may take additional time to process the prescription.”  The policy was implemented after Walgreens was fined $80 million by the DEA for violating rules for dispensing controlled substances.

CVS adopted a policy in 2017 to limit the dose and supply of opioids for short-term, acute pain to seven days. For both acute and chronic pain, opioid prescriptions were not filled if they exceeded a 90mg MME daily dose. Customers enrolled in CVS’ pharmacy benefit plan were also required to try immediate release formulations, before using extended release opioids. The policy was adopted after CVS was fined hundreds of millions of dollars for violations of the Controlled Substances Act.

In a recent letter to the CDC, the American Medical Association called the CVS and Walgreens policies "inappropriate" because they misapplied the CDC opioid guideline in ways that were harmful to patients. The AMA said it has received numerous complaints about Walgreens pharmacists refusing to fill prescriptions because of corporate policy.

Other big pharmacy chains have similar policies. Walmart has been accused of “blacklisting” doctors for writing high dose prescriptions. And a tearful video posted online by a California woman with stage 4 breast cancer went viral after a Rite Aid pharmacist refused to fill her prescription for Norco.

The law firms that filed the cases against Walgreens, Costco and CVS are seeking additional information from patients interested in joining the legal action at this website.

Former VP of Genetic Test Company Pleads Guilty to Paying Doctors Illegal Kickbacks

By Pat Anson, PNN Editor

The former vice-president of marketing for a controversial genetic testing company has pleaded guilty in federal court to paying physicians millions of dollars in illegal kickbacks to order genetic tests for Medicare patients.

Donald Matthews, who was Vice President of Market Development for Proove Biosciences, pleaded guilty this week in federal court. Matthews faces up to 5 years in prison and a $250,000 fine when he’s sentenced in October.

Proove filed for bankruptcy in 2017 after its headquarters in Irvine, California was raided by FBI agents. The company specialized in DNA testing that supposedly identified whether a patient is at risk of opioid addiction and what medications would best treat their pain. Proove said its tests, which cost thousands of dollars, were proven effective in peer-reviewed clinical studies, but a genetic expert told STAT News the studies were “hogwash.”

According to Matthews’ plea agreement, Proove paid doctors at least $3.5 million to induce them to order DNA tests for their patients.  The company then billed Medicare approximately $45 million to pay for the tests and received about $21 million in unlawful payments.

“Proove concealed the true nature of the kickbacks by falsely characterizing the payments as compensation for participating in a clinical research program sponsored by Proove,” the U.S. Attorney’s Office in San Diego said in a statement. “In furtherance of the scheme, Proove placed its own employees in doctors’ offices.  The Proove employees collected a cheek swab and completed most of the paperwork associated with the ‘clinical research’ program.”

Prosecutors say Proove paid kickbacks to an undisclosed number of doctors throughout the country, with the payments tied to how many DNA tests that a doctor ordered. When doctors complained about delayed or reduced payments, a Proove executive demanded that they increase their testing volume. 

“Kickbacks corrupt the medical judgment of physicians, generate unnecessary tests and treatments, increase health care costs, and create unfair competition,” said U.S. Attorney Robert Brewer.

‘A Waste of Time and Money’

As PNN has reported, a non-profit healthcare system in Great Falls, Montana had a Proove “patient engagement representative” employed on site at the Benefis Pain Management Center.

“We had a meeting one day and here are these people from Proove Biosciences. They told us they were doing a research project,” said Rodney Lutes, a physician assistant who was later fired by Benefis. “They wanted to come to Benefis, into the pain department, and test our patients.  We were told this would be at no cost to the patient. My understanding was that they weren’t going to charge anybody, but I found out afterwards they were charging insurance companies.

“They said providers who participated in this would get some form of payment for participating in the program and for filling out all the paperwork.”

Lutes’ supervising physician at the clinic was Katrina Lewis, MD, a pain management specialist at Benefis who was on Proove’s Medical Advisory Board. Benefis has denied that Lewis or any of its employees received kickbacks from Proove for referring business to them. The clinic also said the DNA tests were voluntary and only done on patients if they were appropriate.

 A copy of the clinic’s opioid policy obtained by PNN indicates the tests were mandatory for some patients.

“All patients on dosing levels at or higher than the maximum policy dose MUST be submitted for genetic testing,” the policy states.  

Proove had two types of tests for patients in pain management, an “Opioid Risk Test” and an “Opioid Risk Profile.” According to Proove, the tests could determine a patient’s risk of abusing pain medication.

A Benefis patient who took the tests said they were “a waste of time and money.”

“The meds it said I should be taking either didn’t work, stopped working, or made me sick. And the meds I should not be taking I do just fine on,” she told PNN.

Feds Warn of Scammers Impersonating DEA Agents

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration is once again warning doctors, pharmacists and the public about criminals posing as DEA agents or other law enforcement officers and attempting to extort money from them.

The scammers call the victims, often using caller ID to appear as a legitimate DEA phone number, and threaten arrest and prosecution for violations of federal drug laws unless the victim pays a “fine” over the phone or by wire transfer. Doctors and pharmacists are usually threatened with revocation of their DEA registrations, which allow them to prescribe or dispense opioids and other controlled substances.

A DEA spokesperson told PNN the scam has been going on for years, but the agency has recently seen an uptick in complaints, sometimes hundreds per week.  

“We at headquarters have gotten to the point where we are just inundated with reports of scam calls,” said DEA spokesperson Katherine Pfaff. "And scammers calling us.”

The scammers are now also targeting the general public, according to Pfaff, sometimes claiming that a vehicle intercepted at the border with illegal drugs had been traced back to them.

“No DEA agent would ever contact someone directly like that and insist on payment over the phone or use scare tactics like that. That’s not how we operate,” Pfaff said. “Unfortunately, we have received many reports of people who have actually paid these scammers and lost a lot of money to them.”

The scam tactics continually change, but often share many of the same characteristics. Callers typically use an urgent and aggressive tone, and refuse to speak to anyone other than the intended victim. They demand thousands of dollars via wire transfer or in the form of untraceable gift cards taken over the phone.

Scammers ‘Well Informed’ of DEA Tactics

When calls are made to doctors or pharmacists, the scammers will reference their DEA registration numbers and state license numbers. They also might claim that patients have made accusations against them.

The scammers appear to be aware that many practitioners are already under scrutiny by the DEA for their opioid prescribing practices. In recent years, the DEA has raided and prosecuted hundreds of doctors for alleged infractions. The cases often end with doctors paying a fine rather than face hefty legal bills defending themselves in court.

“The scammers are well enough informed of the tactics DEA is employing against controlled-medication prescribers to be able to replicate them,” says attorney Michael Barnes, who has called for an end to “indiscriminate raids” on doctors.  

“Like the DEA, the impersonators are claiming to have evidence of wrongdoing against licensed health care providers, threatening to revoke DEA registrations, and demanding enormous settlements to make the nightmare go away. The only thing that is missing is the office raid.”

Impersonating a federal agent is a violation of federal law. The DEA urges anyone receiving a  call from a scammer claiming to be with the DEA to report it online to the agency’s Diversion Control Division or by calling 877-792-2873.