Quell Customers to Receive $3.9 Million in Refunds

By Pat Anson, PNN Editor

The U.S. Federal Trade Commission is sending refunds of nearly $3.9 million to consumers who bought Quell, a wearable nerve stimulation device touted as a drug-free treatment for chronic pain. The refunds are part of a settlement the FTC reached in March with NeuroMetrix – the maker of Quell – over deceptive advertising.

An FTC complaint alleged that NeuroMetrix and CEO Shai Gozani advertised Quell as an effective treatment for fibromyalgia, osteoarthritis, sciatica, shingles and other chronic pain conditions without reliable scientific evidence to back it up.  

Two clinical studies cited in Quell advertisements had “substantial flaws,” according to the FTC, while a third study was based on a marketing survey conducted by the company to “generate potential advertising claims” about the device. The FTC also objected to claims that Quell was “clinically proven” and “FDA cleared” for chronic pain relief.

“Defendants engaged in their unlawful acts and practices repeatedly over a period of more than four years, continued their unlawful acts or practices despite knowledge of complaints that advertising claims for Quell were not substantiated and went beyond claims the FDA allowed for similar devices, and continued such deceptive advertising unabated until FTC staff notified them it would recommend law enforcement action,” the FTC complaint said.

Neurometrix settled the case – without admitting or denying the allegations – for $4 million. The company also agreed to stop claiming that Quell provides relief for chronic or severe pain beyond the knee area where the device is worn.

The FTC is using the settlement funds to send 2,144 refund checks and 67,998 refunds via PayPal to Quell purchasers. The average refund amount is $55.10 per customer. Consumers who do not receive a refund, but believe they should, should contact the refund administrator, Rust Consulting, at 1-866-403-6545.

The Quell device sells for $299, while an older version is available for $199. Quell is sold over-the-counter, does not require a prescription and is not usually covered by insurance.

NeuroMetrix recently announced that Quell will be used in a clinical trial on the use of transcutaneous electrical nerve stimulation (TENS) for chemotherapy-induced peripheral neuropathy  The study is being conducted at the University of Rochester School of Medicine and Dentistry, with funding from the National Institutes of Health. Quell is also being evaluated in a small study as a treatment for fibromyalgia.

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.

Surviving COVID-19 Together

By Cynthia Toussaint, PNN Columnist

I’m a survivor. At least that’s what I’m called now that I’ve fought my way into cancer remission.

But why the new acknowledgement? As a person who’s endured childhood trauma and decades of high-impact pain with 15 comorbidities, including chronic fatigue, I earned the “survivor” label a lifetime ago. My world has been up-ended and negatively impacted in most every way since 1982.

It’s just that the aforementioned health crises were never taken as seriously. But because I’ve made it through the most aggressive form of breast cancer, I’m at last an honest-to-goodness, card-carrying survivor. Okay, I guess I’ll take it.

In any event, as a person who’s been seriously ill for nearly four decades, I’m accustomed to going from the frying pan into the fire. True to form, after enduring six months of grueling cancer treatment, I find myself coming out of a long, dark tunnel just to step into a bizarre new one. Enter COVID-19.

Yes, I’m alive, recovering well and wanting to move forward. Trouble is, there is no moving forward during this pandemic. 

More troubling, while able-bodied friends who can’t imagine life-long illness try to give comfort by reminding me that I just have to get into the new, temporary COVID rhythm, I suspect something more ominous will bring me my next survivorship card. And I’m concerned we’ll all own a piece of that plastic.

If you think about it, COVID-19 appears to be globally playing out just like a chronic illness. The virus started as something new and relatively small, a nasty bug that was different, but nothing to write home about. As it picked up steam, the threat settled in and the masses went into crisis mode. Now people are cut-off, lonely and depressed while longing for the life they had. Sound familiar?

Deep down, I’m sadly sensing there’s no going back. Like severe chronic illness, temporary isn’t an option once life has fundamentally changed on a profound level. Bad begets bad as things start going down the rabbit hole. And what of the pandemics to come?  I’m guessing the best we can hope for is acceptance and learning a new way of life. A new normal, if you will.

I don’t think healthy people have the ability or perspective to grasp this possibility. I don’t blame them, that’s understandably too bitter a pill. But that’s what we with high-impact pain do -- continue to adopt new normal after new normal due to loss, abandonment and disappointment. We carry on.

Still, right now, I deserve to be out-of-my-mind angry.

Being a cancer survivor means living with acute anxiety. If my cancer recurs, it will most likely be in the first year or two and much more aggressively. I want to live every moment I have to the fullest, but the world is shut down. I ponder whether my life partner John and I will ever again have an intimate dinner with friends, travel to an exotic destiny or go to a ballgame. I chose to fight cancer like a Tasmanian devil with the promise of life if I won mine. This feels like a massive bait and switch.

While I have the right to be hugely teed off, I’m trying like hell to make a different choice. I’m moving away from bitterness, as I learned long ago that sour grapes don’t get me squat. As my surrogate dad used to lovingly remind me, “It is what it is.”

Healthy Habits

So here’s what I’m doing to take my best shot at maintaining remission, keeping my pain in check and, yep, be a COVID survivor.

I’m using my quiet time to learn how to live the healthiest of lifestyle choices so my “terrain” will remain cancer hostile. Besides diet, exercise and finding purpose, this includes stress-management, the “Big Balance” that I’m finally learning  to master. In fact, I’m enjoying shedding my reputation as the woman who gets five things done before breakfast.

It starts with quality sleep, a HUGE challenge due to fibromyalgia and chronic fatigue syndrome. These days I’m in bed before 9pm. During this sacred, unwinding time, I don’t listen to COVID coverage or use my iPhone before falling asleep around 11pm. Instead, I meditate, tune into stimulating talk radio, and spend loving time with John and our two kitties. Happy to report I’m sleeping more restoratively than I have in two decades. And it feels like a miracle!

Another new healthy habit is checking in with my body several times a day. I lovingly ask what it needs, then nourish it. I’m deeply listening to its wisdom for the first time in my life. For example, I no longer count my swimming laps, but instead stop when it feels right. And I call it quits with my forever meaningful work before I skid into fatigue. If you know me, you know this is the new me. I’m even learning how to say “no.”  

I occasionally see a few close friends while social distancing, and John and I spend long, relaxing evenings at our neighborhood park. We eat plant-based whole foods (amping up our intake of fruits, veggies, nuts and berries), play backgammon, people/dog watch, and just sit and talk as the sun sets. I’m reconnecting with my love of film, books and music — and I’m considering getting an acting agent for disabled talent, as well as diving deep into French language and culture, a longtime passion of mine.

Perhaps most important, I live in Gratitude. I thank God for every day, for every miracle that knocks at my door. I’ve always been juiced by the big things; now the little things are just as gorgeous and life affirming. And I hold onto hope. You gotta have hope.

Hey, maybe the new normal to come will be glorious. It’s really up to us. We with high-impact pain have adaptive super powers that can lead the way for those newly initiated to serious life upset. We can be the example. Let’s stay calm, mask up, hand wash and do a dance (while six feet-apart).

I’m more than willing to add COVID survivor to my list of making-do-with-the-impossible. I gain strength and grace from knowing we’re in this together.

We got this.      

Cynthia Toussaint is the founder and spokesperson at For Grace, a non-profit dedicated to bettering the lives of women in pain. She has lived with Complex Regional Pain Syndrome (CRPS) and 15 co-morbidities for nearly four decades. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.” 

Election May Determine Whether Marijuana Will Be Decriminalized

By Dr. Lynn Webster, PNN Columnist

“Times have changed. Marijuana should not be a crime,” Sen. Kamala Harris (D-CA) said last year when she and Rep. Jerry Nadler (D-NY) introduced the Marijuana Opportunity Reinvestment and Expungement Act (MORE Act). The current Democratic vice-presidential nominee called the legalization of marijuana an important step "toward racial and economic justice."

“We need to start regulating marijuana and expunge marijuana convictions from the records of millions of Americans so they can get on with their lives," said Harris.  

"Racially motivated enforcement of marijuana laws has disproportionally impacted communities of color. It’s past time to right this wrong nationwide and work to view marijuana use as an issue of personal choice and public health, not criminal behavior," added Nadler, who chairs the House Judiciary Committee.

Thirty-three states and the District of Columbia have legalized medical cannabis and several states allow its recreational use.  If it became law, the MORE Act would decriminalize marijuana at the federal level by removing it as a Schedule I controlled substance.

That wouldn't instantly remove all restrictions; states could still prohibit the sale of cannabis. But the MORE Act would give states more latitude to create laws to suit their needs, establish a trust fund to support programs for communities impacted by the war on drugs, and destroy or seal records of marijuana criminal convictions.

Game Changing Legislation

This week the House Judiciary Committee passed the MORE Act and later this month the full House is expected to approve the bill and send it to Senate. Chances are the bill will not pass the Senate, because Majority Leader Sen. Mitch McConnell (R-KY) opposes it -- while paradoxically supporting hemp farming.

However, if the MORE Act passes, it would be a game changer. It could open the floodgates for the development of products that contain tetrahydrocannabinol (THC), which is the psychoactive compound in marijuana.  Some research suggests THC alone, or THC and cannabidiol (CBD) combined, could be more effective than CBD alone for treating pain, anxiety, insomnia and other conditions. More research could discover life-changing new treatments.

Since THC has rewarding properties, such as inducing euphoria, any drug that includes THC would likely be a controlled substance. Nevertheless, decriminalizing marijuana would create enormous economic opportunities for growers and anyone in the business of finding solutions to medical problems for which marijuana or its derivatives may be useful.

It doesn’t seem likely that marijuana will be decriminalized at the federal level this year. Congress criminalized marijuana in 1937 and all attempts to reform the law at the federal level have ultimately failed. Our current Senate is unlikely to change the status quo.

But the upcoming election will likely determine whether the MORE Act has a chance to become law in the near future. Democratic presidential candidate Joe Biden supports legalization and decriminalization at the federal level, while President Trump is generally opposed to changing federal marijuana laws. The election will also determine which party controls the House and Senate.

It behooves every voter to become familiar with the candidates' positions regarding cannabis. Criminalizing marijuana has caused great harm. We, as voters, have the power to change that.  

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find him on Twitter: @LynnRWebsterMD.

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.

Meeting the Doctor Who Helped Me Most

By Barby Ingle, PNN Columnist

In honor of September being Pain Awareness Month, I wanted to give homage to the doctor who helped me most over the past 20 years. He was in my life for about 6 years of this journey, before he retired, but he has given me tools for a lifetime.

When I arrived at Dr. Robert Schwartzman’s office for the first time, I was excited. I had met him a few years prior at a medical conference, where he agreed to treat me. Dr. Schwartzman is one of the world’s leading experts on Reflex Sympathetic Dystrophy (RSD), also known as Complex Regional Pain Syndrome (CRPS). Due to high demand from other patients, there was a waiting list to see him.

I was in my wheelchair and had made the trip to Pennsylvania from Virginia, where I was staying with my sister and her husband. At the time, I was hurting all over and many of my symptoms were flaring due to the travel.  I had many types of pain going on: burning, stabbing, electric, shooting, deep, surface and bone pain. I was dizzy and felt nauseated.

My name was called and my sister and I went to the exam room. The nurse was very nice and asked all the right questions. She had me put on a gown. Then we waited.

When Dr. Schwartzman walked into the exam room to see me, he was followed by about 9 student doctors. His first words were, “Now she has Reflex Sympathetic Dystrophy. Anyone should be able to see it at first glance.” He then began pointing out all of the symptoms I had from the RSD. He knew things before I even said anything.

The doctors saw the blanching in my skin. From my face to my feet, I had discoloration. I never paid that much attention to how bad it had gotten over the years; maybe because it happened over time. I took pictures of it, but did not know that it meant RSD had spread to those areas.

The most severe burning pain was on the right side of my body. I had all the other types of pain on the left side, but the atrophy and lack of coordination were not as bad.

DR. ROBERT SCHWARTZMAN

When Dr. Schwartzman began to do neurological testing on both sides, I felt the pain. The right side was worse, but the left side was definitely affected. He discussed me being diagnosed incorrectly by my other doctors with Thoracic Outlet Syndrome and having my rib removed twice. He also guessed correctly that I had been diagnosed with temporomandibular joint dysfunction (TMJD) because of the facial pain and that I was having issues with my thyroid.

He remarked about my sweating, the swelling in some areas, and asked about my low-grade fevers, Horner syndrome and more. He discussed and noted the atrophy in my hands, arms, legs, feet, face, back and the dystonia in my hands and feet. By discussed, I mean he discussed it with the other doctors. Dr. Schwartzman hardly spoke to me.

Next, he had me do neurological tests. An easy one that you can do right now involves your hand. Take the tip of your index finger and tap it to the tip of your thumb as many times and as fast as you can. I thought that I did it very well, especially with my left hand. But Dr. Schwartzman explained the way I did it was awkward and slow, which was another symptom.

I did not understand, so he showed me. He could tap his fingers so fast that it looked like I was going in slow motion. Since then, when I ask others to do the same thing, I am amazed that I cannot go as fast, no matter how hard I try.

He watched me smile, had me stick my tongue out, and then asked if I had trouble swallowing and if my voice goes in and out sometimes. I said, "Yes, how did you know?" He said that the RSD was affecting my throat and intestines.

I had been diagnosed with gastrointestinal ischemia and gastroparesis a few years earlier. The hospitalist that performed the tests said there is a section of my intestines that was getting little to no blood. I did not understand how that was related to the RSD until I saw Dr. Schwartzman and learned that RSD causes vascular constriction, which can make it difficult to get an IV line inserted or even do blood tests.

I never realized that vascular constriction could also affect organs. I thought I was just eating too quickly or being lazy when I choked on food. I did not know why my voice changed or why I would lose it sometimes. The RSD even affected the way my nails and hair grow.

Dr. Schwartzman was spot on with everything. He added that whiplash or brachia plexus injuries are a leading cause of upper extremity RSD. Because of my additional traumas and surgeries, the RSD had spread.

Ketamine Infusions

Sometime near the end of the exam, Dr. Schwartzman said to the student doctors, “The only thing that will help this patient 100% is the coma treatment.”

I was shocked. I thought I was going to be getting outpatient ketamine infusions. I began to tear up. I kept telling myself not to cry. It is never good to cry at a doctor’s office. I wanted to be taken seriously and be strong. As soon as they left the room, tears flowed down my face. The nurse said she would be right back with all of the instructions and scripts that he was giving me.

I did not have any idea of the issues that were involved with RSD or that I had many of the symptoms. Instead of starting right away, I had to wait another 9 months to get a bed in the hospital, where I underwent 7 days of inpatient ICU ketamine infusions.

I went into the hospital in a wheelchair, but walked out on my own a week later, ready to live the next chapter in my life. That was Dec. 14, 2009. I still undergo ketamine infusion therapy about 4 times a year for booster treatments, but I am no longer on daily medications for pain.

I thank Dr. Schwartzman and all the research doctors out there coming up with treatments and scientific data for people like me with chronic rare diseases and severe life changing pain. We should always remember there is reason for hope. We just have to be active in seeking and using all of the resources available.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website.  

Lupus and Arthritis Patients at No Greater Risk from COVID-19

By Pat Anson, PNN Editor

Patients with lupus and other forms of arthritis are not at increased risk of being hospitalized with COVID-19 due to medications that weaken their immune systems, according to researchers at NYU’s Grossman School of Medicine.

Lupus, spondyloarthritis, psoriatic and rheumatoid arthritis are autoimmune conditions in which the body’s immune system attacks joints, skin, kidneys and other tissues, causing pain and inflammation. The arthritic conditions are often treated with steroids, biologics and other immune suppressing medications, which has raised concern that the drugs could also make patients more susceptible to risks from coronavirus infection.

But in two studies recently published in the journal Arthritis and Rheumatology, researchers found that most patients with arthritis had the same risk of hospitalization as the general population.

“People with lupus or inflammatory arthritis have the same risk factors for getting seriously ill from COVID-19 as people without these disorders,” said co-author Ruth Fernandez-Ruiz, MD, a postdoctoral fellow in rheumatology in the Department of Medicine at NYU Langone.

The first study involved 226 adult patients in New York City who were being treated for mild to severe forms of lupus between April 13 and June 1, when the coronavirus pandemic peaked in the New York City region. Forty-one of the lupus patients were also diagnosed with COVID-19. Of those, 24 were hospitalized and four died. Another 42 patients had COVID-19-like symptoms but were not formally tested.

The second study involved 103 women being treated for inflammatory arthritis between March 3 and May 4 in New York City. All tested positive for COVID-19 or had symptoms highly suggesting they were infected. Twenty-seven of them were hospitalized and four died.

Researchers say the lupus patients taking immune-suppressing medications such as mycophenolate mofetil (Cellcept) and azathioprine (Imuran), had no greater risk of hospitalization than patients not using the drugs. Similarly, hospitalization rates for people with inflammatory arthritis and COVID-19 were no greater than for all New Yorkers.

“Patients receiving therapy for lupus and inflammatory arthritis should not automatically stop taking their medications for fear that they would be worse off if they also caught the coronavirus,” said co-author Rebecca Haberman, MD, a clinical instructor in rheumatology in the Department of Medicine at NYU Langone.

Haberman and her colleagues say arthritis patients taking biologic drugs such as adalimumab (Humira) and etanercept (Enbrel), or the antiviral drug hydroxychloroquine, were also at no greater or lesser risk of hospitalization than those not taking the drugs.

However, arthritis patients taking glucocorticoids, a type of steroid, even in mild doses, were up to 10 times more likely to be hospitalized than patients not using steroids. The researchers caution that although statistically significant, the study’s small size may overestimate the actual risk from steroids.

“Our findings represent the largest of its kind for American patients with lupus or arthritis and COVID-19, and should reassure most patients, especially those on immunosuppressant therapy, that they are at no greater risk of having to be admitted to hospital from COVID-19 than other lupus or arthritis patients,” said Fernandez-Ruiz.

Risk factors that can double the risk of hospitalization from COVID-19 are having multiple health conditions, such as obesity, hypertension and diabetes.

Can LSD Be Used to Treat Pain?

By Roger Chriss, PNN Columnist

The well-known hallucinogen LSD may have a new use. A new study published in the Journal of Psychopharmacology found evidence that LSD exerts a “protracted analgesic effect” at low doses.

The study was performed in The Netherlands on 24 healthy volunteers. Three low doses of LSD or placebo were given to the participants, who immersed a hand in near freezing water 90 minutes and five hours after dosing to assess their pain tolerance.

Results from the “Cold Pressor Test” showed that 20 micrograms of LSD “significantly increased the time that participants were able to tolerate exposure to cold (3°C) water and decreased their subjective levels of experienced pain and unpleasantness.”

It is not clear how or why LSD increased tolerance to cold water. The study authors speculate about LSD’s various actions on serotonin receptors, but also note that “an additional or alternative explanation for the analgesic effects of LSD could be hypertension-associated hypoalgesia.”

There were side effects from LSD, even at low doses. LSD slightly raised blood pressure and increased feelings of dissociation, anxiety and somatization in the volunteers. Psychological and cognitive effects were described as “very mild.”

The study has other important limitations. The Cold Pressor Test is not a good analog for real-world acute pain. And healthy volunteers in such studies tend not to be typical of the population at large. They skew young, male, and often have prior experience with the substance being evaluated that most people do not have.

Also, these studies tend not to translate to real-world use. Recent work on LSD microdosing has found “few benefits and significant downsides.”

Findings Hyped

Unfortunately, this preliminary study has already led to hype about the analgesic potential of LSD. New Atlas called it  “an incredible, first-of-its kind trial” and Futurism reported that LSD microdoses were “as effective as opioids at treating pain.”  Interesting Engineering predicted “there could be possible applications of LSD as a non-addictive pain medication.”

The Beckley Foundation, which funded the study, fed the hype with a news release that claimed the analgesic effects of LSD were “remarkably” similar to oxycodone and morphine, but without the risk of addiction.

“The present data suggests low doses of LSD could constitute a useful pain management treatment option that is not only effective in patients but is also devoid of the problematic consequences associated with current mainstay drugs, such as opioids,” said Amanda Feilding, Founder and Director of the Beckley Foundation. “We must continue to explore this with the aim of providing safer, non-addictive alternatives to pain management, and to bring people in pain a step closer to living happier, healthier and fully expressed lives.”

Misunderstanding Pain Research

The Cold Pressor Test is a standard way to assess pain threshold and tolerance. But results in the test vary significantly with water temperature, and the test is not seen as a precise analog with real-world pain. As a 2016 review noted, “No single experimental model can mimic the complex nature of clinical pain.”

Pain is a biopsychosocial phenomenon involving a long chain of interactions that start with peripheral sensory nerve endings and manifest in the conscious mind. Analgesic effect can be achieved locally in nerve endings, as seen with lidocaine injections; or intermediately in the spinal cord, as seen with radio frequency ablation or spinal cord simulators; or centrally in the brain, as seen with psychoactive drugs.

Therefore, comparing analgesic efficacy is far more complex than just looking at outcomes in a simple lab-induced pain model in a handful of healthy people. The LSD study did not test its subjects with multiple substances or combinations of substances.

Further, analgesics have to be safe and effective. Safety includes understanding possible drug-drug interactions. A 2008 review noted that “lithium and some tricyclic antidepressants have also been reported to increase the effects of LSD.”

A 2019 study describes several important biochemical pathways and gene polymorphisms in LSD metabolism, possibly affecting pharmacokinetics and pharmacodynamics. The article concludes that “drug-drug interaction studies in humans are required to further assess the clinical relevance of these findings.”

Analgesics like acetaminophen have relatively few drug-drug interactions. Opioids have a number of important ones, but these are well-understood and can be controlled. By contrast, cannabis is messy. Drugs.com lists 24 major and 353 moderate interactions for cannabis. There is no such list for LSD.

Pain medication needs to be effective as well as safe and reliable. Demonstrating efficacy requires far more than a handful of willing subjects being subjected to a simulated pain experience in a laboratory setting. Demonstrating safety and reliability will require extensive testing, pharmacodynamic studies, and research on drug-drug interactions. LSD may have taken the first step toward becoming an analgesic, but there is a long road ahead.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research. 

CDC Is Prioritizing Politics Over Science

By Dr. Lynn Webster, PNN Columnist

For most of my career, I have revered the Centers for Disease Control and Prevention (CDC). I believed it had the best scientists in the world, and that we could and should believe everything they said.

Not anymore. Unfortunately, the CDC has devolved into a partisan mouthpiece for politicians and people with agendas not supported by science.

The Academy Award-winning documentary Under Our Skin first showed me how politics can influence decisions at the CDC. The film illustrates how chronic Lyme disease (CLD) can cause a great deal of suffering, including chronic pain and fatigue. But the medical community has been unwilling to respond appropriately because the government has determined that CLD is a "controversial" diagnosis.

As a result, patients with Lyme disease often go undiagnosed and untreated until their symptoms worsen. The ongoing "Lyme wars" make it difficult for them to get testing and treatment.

Contagion is a theatrical movie about a pandemic that shows the CDC making decisions based on the political aspirations of key CDC officers. But this fictional story about a pandemic and the power-seeking nature of CDC officials was unfortunately prescient.

CDC Has Done Better

We have seen the tremendous work the CDC can do worldwide. The Ebola virus was contained, and potentially millions of lives were saved, because of the stellar work of enormously talented and dedicated CDC scientists.

The CDC activated its Emergency Response Center to protect the United States and its territories from the threat of the Zika virus, which can cause birth defects and Guillain-Barré Syndrome. My childbearing-age daughter cancelled trips to areas that the CDC warned posed a high risk.

The agency conducted more than 160,000 Zika virus tests, created registries to track pregnant women who were known to be infected with the virus, and provided $251 million in grants to state and local health departments. Their ongoing efforts to minimize the damage from Zika demonstrates the exemplary work the CDC can perform.

CDC's Politicization Is Not Partisan

The politicizing of the CDC is nothing new. During the Obama administration, the CDC became a tool of anti-opioid zealots. Republican Rep. Harold (Hal) Rogers of Kentucky is a senior member of the House Appropriations Committee. You may have heard his name recently, because he helped determine the amount of the CDC's emergency funding for the coronavirus.  

President Obama joined Rogers at the National RX Drug Abuse and Heroin Summit in 2016 to support increased funding to address prescription drug abuse. That action ignored the larger problem of illicit drug abuse and the fact that the opioid crisis has been mischaracterized as a prescription drug problem.

CDC Harmed Millions With Its Opioid Guideline

When Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group, was unable to get what they demanded from the FDA through a citizen petition, they turned to the CDC, where they found political allies. This led to the now infamous CDC Guideline for Prescribing Opioids for Chronic Pain in 2016. 

The guideline has caused enormous harm to millions of Americans. Recently, the American Medical Association implored the CDC to significantly change the guideline "to protect patients with pain from the ongoing unintended consequences and misapplication of the guidance." Even the guideline’s authors have backpedaled, acknowledging it has been misapplied to withhold opioid medication from patients who need it.

Yet the harm continues. Alarmingly, the Department of Justice interprets the guideline as a mandate, warning and sometimes prosecuting doctors who do not follow its voluntary recommendations. Dozens of states have blindly adopted the guideline in a naïve attempt to address the rising number of drug overdose deaths, either not understanding or ignoring the fact that most overdoses are due to illicit, rather than prescription drugs. 

COVID-19 Flip Flops

Now we see the CDC yo-yoing with their recommendations regarding COVID-19. Initially, the CDC said that masks were not necessary, except for those who were sick or taking care of someone who was sick. Now they recommend that everyone wear a mask. The Trump administration wants to leave that decision up to individuals, so they have not issued a federal mask mandate. This is contrary to the advice of most experts.

The CDC has also stated that testing for COVID-19 is important. But when the administration apparently pressured the CDC to change their position and recommend that asymptomatic people who were exposed to the virus not get tested, they did so, allowing politics to trump (no pun intended) science. CDC Director Dr. Robert Redfeld has now reversed his position and said COVID-19 testing is important for those who have been exposed to the virus, even if they are asymptomatic.

I agree with Dr. Leana Wen, a well-recognized authority on public health, who wrote in The Washington Post that the CDC’s testing guidance was “nonsensical.”

"I worry that this CDC change is part of a larger pattern of diluting recommendations when the federal government can’t do its job properly," Wen wrote.

Perhaps we all should worry. Who and what are we to believe? I, for one, can no longer believe what the CDC says unless it is verified by non-partisan scientific bodies.

This is a sad time. Our health is being played with as if it were a game. I feel like a commoner in Game of Thrones, as the kings fight for power and ignore their people. We, the commoners, should insist that the CDC become an independent agency no longer headed by a political appointee, so it would be unassailable by politicians who are more interested in controlling messages than diseases. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find him on Twitter: @LynnRWebsterMD.

This Is a Good Year to Get a Flu Shot

By Julie Appleby and Michelle Andrews, Kaiser Health News

Flu season will look different this year, as the U.S. grapples with a coronavirus pandemic that has killed more than 180,000 people. Many Americans are reluctant to visit a doctor’s office and public health officials worry people will shy away from being immunized.

Although sometimes incorrectly regarded as just another bad cold, flu also kills tens of thousands of people in the U.S. each year, with the very young, the elderly and those with underlying conditions the most vulnerable. When coupled with the effects of COVID-19, public health experts say it’s more important than ever to get a flu shot.

If enough of the U.S. population gets vaccinated — more than the 45% who did last flu season — it could help head off a nightmare scenario in the coming winter of hospitals stuffed with both COVID-19 patients and those suffering from severe effects of influenza.

Aside from the potential burden on hospitals, there’s the possibility people could get both viruses — and “no one knows what happens if you get influenza and COVID [simultaneously] because it’s never happened before,” Dr. Rachel Levine, Pennsylvania’s secretary of health, told reporters this month.

In response, manufacturers are producing more vaccine supply this year, between 194 million and 198 million doses, or about 20 million more than they distributed last season, according to the Centers for Disease Control and Prevention.

As flu season approaches, here are some answers to a few common questions:

When should I get my flu shot?

Advertising has already begun, and some pharmacies and clinics have their supplies now. But, because the effectiveness of the vaccine can wane over time, the CDC recommends against a shot in August.

Many pharmacies and clinics will start immunizations in early September. Generally, influenza viruses start circulating in mid- to late October but become more widespread later, in the winter. It takes about two weeks after getting a shot for antibodies — which circulate in the blood and thwart infections — to build up.

“Young, healthy people can begin getting their flu shots in September, and elderly people and other vulnerable populations can begin in October,” said Dr. Steve Miller, chief clinical officer for insurer Cigna.

The CDC has recommended that people get a flu vaccine by the end of October, but noted it’s not too late to get one after that because shots can still be beneficial and vaccination should be offered throughout the flu season. Even so, some experts say not to wait too long — not only because of COVID-19, but in case a shortage develops because of overwhelming demand.

While a flu shot won’t prevent COVID-19, getting one could help your doctors differentiate between the diseases if you develop any symptoms — fever, cough, sore throat — that they share.

Getting a shot protects you from catching the flu and spreading it to others, which may help lessen the burden on hospitals and medical staffs. A flu shot won’t prevent all cases of the flu, but getting vaccinated can lessen the severity if you do fall ill. You cannot get influenza from the flu vaccine.

All eligible people, especially essential workers, those with underlying conditions and those at higher risk — including very young children and pregnant women — should seek protection, the CDC said. It recommends that children over 6 months old get vaccinated.

How effective is this year’s vaccine?

Flu vaccines — which must be developed anew each year because influenza viruses mutate — range in effectiveness annually, depending on how well they match the circulating virus. Last year’s formulation was estimated to be about 45% effective in preventing the flu overall, with about a 55% effectiveness in children.

The vaccines available in the U.S. this year are aimed at preventing at least three strains of the virus, and most cover four. It isn’t yet known how well this year’s supply will match the strains that will circulate in the U.S.

Early indications from the Southern Hemisphere, which goes through its flu season during our summer, are encouraging. There, people practiced social distancing, wore masks and got vaccinated in greater numbers this year — and global flu levels are lower than expected. Experts caution, however, not to count on a similarly mild season in the U.S., in part because masking and social distancing efforts vary widely.

Where can I get a flu shot?

Aiming to avoid risky indoor gatherings, many employers are reluctant to sponsor the on-site flu clinics they’ve offered in years past. And with so many people continuing to work from home, there’s less need to bring flu shots to employees on the job. Instead, many employers are encouraging workers to get shots from their primary care doctors, at pharmacies or in other community settings. Insurance will generally cover the cost of the vaccine.

Some pharmacies are making an extra push to get out into the community to offer flu shots.

Walgreens, which has nearly 9,100 pharmacies nationwide, is continuing a partnership begun in 2015 with community organizations, churches and employers that has offered about 150,000 off-site and mobile flu clinics to date. Walgreens began offering flu shots in mid-August and is encouraging people not to delay getting vaccinated.

Both Walgreens and CVS are encouraging people to schedule appointments and do paperwork online this year to minimize time spent in the stores. At CVS MinuteClinic locations, once patients have checked in for their flu shot, they must wait outside or in their car, since the indoor waiting areas are now closed.

“We don’t have tons of arrows in our quiver against COVID,” said Dr. Kevin Ban, Walgreens’ chief medical officer. “Taking pressure off the health care system by providing vaccines in advance is one thing we can do.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.

NIH Study Finds Opioids Make Birds Sing

By Pat Anson, PNN Editor

Opioid medication has been associated with many things, from reduced pain and disability to constipation, addiction and overdoses. A new study has found that opioids also make birds sing.

Researchers at the University of Wisconsin-Madison say fentanyl, a potent synthetic opioid, causes “gregarious singing behavior” in starlings that sounds a bit like modern jazz. Starlings usually sing to attract mates, but these birds sang because they felt good.

“When I listen to these birds sing, it seems as if they are enjoying themselves,” Lauren Riters, PhD, a Psychology Professor at UW-Madison told Psychology Today. “To me, it sounds like free-form jazz riffs.”

The small study by Riters and her colleagues involved a total of 14 European starlings that were injected with either a placebo or small doses of fentanyl. Their findings, recently published in the journal Scientific Reports, suggest that fentanyl reduced stress and anxiety in the birds without making them intoxicated.

“We report that peripheral injections of the selective MOR (mu opioid receptor) agonist fentanyl cause dose-dependent increases in gregarious singing behavior in male and female starlings, while at the same time decreasing beak wiping, which is considered a sign of stress or anxiety. The fentanyl did not affect landings, indicating that fentanyl effects on behavior were not caused by gross deficits in motor activity,” Riters wrote.

Riters is a prolific researcher, participating in dozens of studies on the social activity of starlings, pigeons, quail, finches and other birds, much of it paid for with millions of dollars in federal grants from the National Institutes of Health (NIH).

This particular study was funded by a $338,000 NIH grant to examine “deficits in social communication.” The researchers say their findings could someday be used to treat humans suffering from autism, depression and anxiety. Not to make them sing, but to make them more social.

“Such disorders are characterized by social withdrawal and deficits in the ability to communicate appropriately in distinct social contexts. The proposed research will identify manipulations that stimulate context-appropriate social interactions, which can be used in the design of clinical interventions in humans with context-specific deficits in social communication,” the UW-Madison grant application states.

Some may scoff at her research, but Riters says there are lessons to be learned from it because songbirds, like humans, are social animals that enjoy singing for the same reasons we do: It helps us feel better.

“If this is the case, it would mean that our studies on songbirds are revealing an ancient, evolutionarily conserved neural circuit that regulates intrinsically rewarded social behaviors across many animals,’ she said.

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.