Walmart Sues Feds Over Prescribing Regulations

By Pat Anson, PNN Editor

In an unusual move, Walmart has filed a lawsuit against the Department of Justice and Drug Enforcement Administration, asking a federal court to clarify the “roles and legal responsibilities of pharmacists and pharmacies” in filling opioid prescriptions.

“We are bringing this lawsuit because there is no federal law requiring pharmacists to interfere in the doctor-patient relationship to the degree DOJ is demanding, and in fact expert federal and state health agencies routinely say it is not allowed and potentially harmful to patients with legitimate medical needs,” the company said in a statement.

Walmart and other pharmacy chains are defendants in multiple class action lawsuits alleging the companies helped fuel the opioid crisis by dispensing opioids irresponsibly. They have also been fined tens of millions of dollars by the DEA for lax controls on opioid prescriptions. According to ProPublica, federal prosecutors in Texas even sought criminal charges against Walmart, but were overruled by top officials at the Department of Justice.

Walmart is the largest retailer in the world and operates over 5,000 in-store pharmacies in the United States. The company said it filed suit against the DOJ and DEA because it was caught “between a rock and a hard place” over opioid prescribing.    

“Unfortunately, certain DOJ officials have long seemed more focused on chasing headlines than fixing the crisis. They are now threatening a completely unjustified lawsuit against Walmart, claiming in hindsight pharmacists should have refused to fill otherwise valid opioid prescriptions that were written by the very doctors that the federal government still approves to write prescriptions,” Walmart said.

“At the same time that DOJ is threatening to sue Walmart for not going even further in second-guessing doctors, state health regulators are threatening Walmart and our pharmacists for going too far and interfering in the doctor-patient relationship. Doctors and patients also bring lawsuits when their opioid prescriptions are not filled.”

‘Corresponding Responsibility’

Under current law, pharmacists have a “corresponding responsibility” when filling prescriptions – a legal right to refuse to fill prescriptions they consider unusual or improper. Most pharmacists will call the prescribing doctor to double-check before turning away a patient, but Walmart and other pharmacies have gone even further by blacklisting doctors deemed to have questionable prescribing practices.  

That’s what happened to a nurse practitioner at an Arizona pain clinic, who received a letter from Walmart in 2018 saying it would no longer fill her prescriptions – even though there was no indication any of her patients had been harmed by opioids.

“In reviewing your controlled substance prescribing patterns and other factors, we have determined that we will no longer be able to continue filling your controlled substance prescriptions,” the letter states.

“It was very humiliating. I was upset about it,” said nurse practitioner Carolyn Eastin. “We’ve already had patients who can’t get prescriptions there.”

A former Walmart pharmacist told PNN the company closely monitors opioid prescriptions and the doctors who write them.

“They had assembled prescription numbers for every doctor who had filled prescriptions at my store. They knew the exact number of medications ordered and sold down to the tablet. They knew what drugs the doctors wrote for and what percentage of the total each drug they wrote for," the pharmacist explained.

In its statement, Walmart said its pharmacists “refused to fill hundreds of thousands of opioid prescriptions they thought could be problematic” and had “blocked thousands of questionable doctors from having their opioid prescriptions filled.” The company also said it frequently assisted law enforcement agencies in “bringing bad doctors to justice.”

Caught in the middle of this are pain patients with legitimate prescriptions that are not getting filled. In August, two patients filed class action complaints against Walgreens, Costco and CVS alleging they were discriminated against by the pharmacies.

As PNN has reported, Sen. Elizabeth Warren (D-MA) and other members of Congress are urging the DEA to update a regulation that would allow pharmacists to only partially fill an opioid prescription. Patients would have to return a second time to get the rest of their medication.

The Devil Effect on Patients with Pain

By Dr. Lynn Webster, PNN Columnist

Society's response to pain management has shifted over the years. While pain treatment today often generates controversy, in the past it was viewed differently.

During the U.S. Civil War, a wounded soldier who was in agony was often given enough chloroform “to render him insensible to pain." Afterwards, soldiers may not have recalled the pain they felt, even if they remembered having surgery. We were concerned enough for our soldiers to ease their suffering with the most effective medication that was available.

At other periods in our history, society worried more about the risks of treating pain than the debilitating and sometimes lethal effects of the pain itself. At times, we even questioned whether pain was real and whether people were just inventing symptoms to receive attention or drugs.

People with pain have often been stigmatized. They have been expected to just tough it out, and those who couldn't were accused of being weak.

The Pendulum Swings Toward Empathy

In the 1990s, most people dying of cancer experienced excruciating pain, despite the fact that doctors had the means to help them. Opioids could ease their suffering. And a consensus began to grow in the medical profession that prescribing opioids for cancer-related pain was the right thing to do. Soon after, doctors began prescribing opioids for non-cancer pain, such as arthritis. The number of prescriptions increased.

Treating pain with opioids became acceptable -- even expected -- when the alternative was to let people suffer. It seemed reasonable at the time. There was little evidence then that opioids would cause serious harm if people used the pain medication as directed.

We always acknowledged that a subset of the patient population was at risk for abuse or addiction. Pain doctors like me did the best we could for patients with the research that was available to us at the time. Perhaps, in some cases, we would do things differently now.

Casting Blame for the Opioid Crisis

Ultimately, “overprescribing” was recognized as one of the contributors to America’s drug crisis. Looking back, it is easy to cast blame. We now have better information about the risks of using opioids. But there were few effective tools at the time to control pain, so prescribing opioids seemed like a valid alternative to letting patients suffer unnecessarily.

As more opioids were prescribed, there was a corresponding increase in all drug overdoses. That set off alarms, even though the causes of overdoses are myriad and complicated, and there is no simple correlation between rising opioid prescriptions and increased overdose deaths.

Societal attitudes began to shift again in the first decade of the 21st century. Families who lost loved ones to overdoses were looking for someone to blame. There were public and private demands to hold someone accountable for their deaths. The initial target was the pharmaceutical industry.

This wasn't anything new. The American public has more hostility toward Big Pharma than any other industry. A 2019 Gallop poll found that the public felt more distrust of Big Pharma than they did of the federal government!

The news media covered the tragedies of teenagers and young adults who were dying from overdoses. Often, those deaths involved opioids. The media also covered stories of families torn apart by addiction. Then the media's narrative shifted to allegations of deceit, greed and cover-ups by the pharmaceutical industry.

At first, they focused on Purdue Pharma. The company was making billions of dollars from OxyContin, and they were accused of irresponsibly promoting its use. The federal government filed a lawsuit against Purdue Pharma and this week announced a $8.3 billion settlement with the company.  

I recall the initial complaints about OxyContin were unrelated to the increased number of opioid related overdoses. Instead, Workers Compensation groups were complaining about the skyrocketing cost of the drug. In the late 1990’s, I recall hearing the medical director of Utah’s workers’ compensation program speak to the local pain society. He angrily insisted that the cost of OxyContin was exploding and must be stopped.

A new "Opium War" had begun. But this time, it was not between the Chinese and British. Instead, it involved health insurers and opioid manufacturers.

Chasing a Pot of Gold

The need to blame someone for the overdoses and make them pay for the harm opioids caused accelerated. Opioid manufacturers and physicians were in the cross-hairs of policymakers and law enforcement agencies.

Opioid distributors and patient advocacy groups were also accused of contributing to the drug crisis. It was alleged that distributors knowingly and irresponsibly supplied communities with large amounts of pills that far exceeded the amount needed for medical purposes. Advocacy groups were accused of being front organizations for opioid manufacturers. Whether or not distributors were irresponsible depends on one’s perspective, but the accusation about patient organizations was often baseless and malicious.

Of course, the bandwagon of accusers grew as the potential pot of gold increased. Lawsuits filed by states, cities and counties could result in a golden egg if they could convince a sympathetic jury or judge that they had been wronged. The sympathies of the public turned more and more against the drugs used in pain treatment.

The Devil Effect Harms Us All

Greed and the harm it causes is a well-known story. However, what is not as well appreciated is how it leads to a cognitive bias called the "devil effect" -- in which one bad quality creates the impression that there must be only negative qualities associated with a person or entity.

The belief that Big Pharma is inherently bad makes it difficult to appreciate the good things (such as vaccines and cures) that come from the industry, and to separate it from the bad things. Today, when doctors consult with or accept any funding from the industry, particularly the companies that make opioids, it is often referred to as “being in bed with the devil.”

Society’s belief that Big Pharma is inherently evil helps explain why people in pain are struggling. The truth is, Big Pharma is not intrinsically bad -- although there are some bad actors in the industry -- and drugs used to manage pain are essential partners in healing when used appropriately.

Our tendency toward black or white blanket perceptions -- and our choice to not learn about the complexities that would allow for a more balanced approach in our reasoning -- has consequences for every aspect of society. When it comes to pain management, the devil effect has yielded the terrible unintended cost of suffering by innocent people.

The pendulum eventually may swing back toward empathy for people who are suffering, but not until more people recognize the influence the devil effect has on society's attitudes towards Big Pharma, opioids and people in pain.

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 Lynn on Twitter: @LynnRWebsterMD. 

An Aspirin a Day May Keep COVID at Bay

By Pat Anson, PNN Editor

Ever since the start of the pandemic, there has been a lively and sometimes heated debate over anti-viral medications like hydroxychloroquine and remdesivir – and whether they can treat or even prevent COVID-19 infections.  

It turns out one of the most effective drugs is a simple and inexpensive pain reliever that most people already have in their medicine cabinets: aspirin.

A new study by researchers at the University of Maryland School of Medicine found that hospitalized COVID-19 patients who took a daily low-dose aspirin had significantly lower risk of complications and death. Aspirin takers were less likely to be placed in an intensive care unit (ICU) or be hooked up to a mechanical ventilator, and they were much more likely to make it out of the hospital alive.

"This is a critical finding that needs to be confirmed through a randomized clinical trial," said study leader Jonathan Chow, MD, Assistant Professor of Anesthesiology at UMSOM. "If our finding is confirmed, it would make aspirin the first widely available, over-the-counter medication to reduce mortality in COVID-19 patients."

Chow and his colleagues say their study, published in the journal Anesthesia and Analgesia, provides "cautious optimism" that a daily low-dose aspirin (usually 81 milligrams) can help prevent severe COVID-19 complications.

Millions of older adults already take aspirin daily to lower their risk of heart attack or stroke.

“If our finding is confirmed, it would make aspirin the first widely available, over-the-counter medication to reduce mortality in COVID-19 patients.”

— Dr. Jonathan Chow

Researchers analyzed the medical records of 412 COVID-19 patients, aged 55 on average, who were hospitalized at the University of Maryland Medical Center in Baltimore and three other hospitals on the East Coast. About a quarter of the patients were taking a daily low-dose aspirin before they were admitted or right after admission to manage their cardiovascular disease.

Researchers found aspirin reduced the risk of being put on a ventilator by 44 percent, lowered the risk of being put in ICU by 43 percent, and reduced the risk of dying in the hospital by 47 percent.  Patients who took aspirin daily also had less risk of adverse events such as major bleeding.

COVID-19 infections increase the risk of blood clots that can form in the heart, lungs, blood vessels and other organs. Complications from blood clots can lead to heart attacks, strokes, organ failure and death.

"We believe that the blood thinning effects of aspirin provides benefits for COVID-19 patients by preventing microclot formation," said co-author Michael Mazzeffi, MD, Associate Professor of Anesthesiology at UMSOM. "Patients diagnosed with COVID-19 may want to consider taking a daily aspirin as long as they check with their doctor first."

Doctors often recommend a daily “baby” aspirin for patients who have cardiovascular disease. They caution, however, that aspirin can increase the risk of bleeding when taken in combination with other medications like steroids or blood thinners.

"While confirmatory studies are needed to prove that aspirin use leads to better outcomes in COVID-19, the evidence thus far suggests that patients may want to discuss with their doctor whether it is safe for them to take aspirin to manage potentially prevent serious complications," said E. Albert Reece, MD, Dean of the University of Maryland School of Medicine.

Researchers from Wake Forest School of Medicine, George Washington University School of Medicine, Northeast Georgia Health System, and Walter Reed National Military Medical Center also participated in the study.

Fentanyl and Heroin Use Rise During Pandemic

By Pat Anson, PNN Editor

The use of illicit fentanyl and heroin rose dramatically during the first two months of the COVID-19 pandemic, according to a large new study by Quest Diagnostics. Misuse of hydrocodone, morphine and some other opioid medications also increased.

The study adds to growing signs that Americans are turning to potent illicit drugs to cope with the stress and economic disruption caused by the pandemic.

“It’s the social isolation, the depression, the anxiety, stress, job loss, the loss of health insurance and the election. All these things that add stress to our lives are driving people to increase use of alcohol at home and, in the case of this study, drug misuse,” said co-author Harvey Kaufman, MD, Senior Medical Director for Quest Diagnostics. 

Kaufman and his colleagues analyzed data from over 872,000 urine drug tests, comparing samples taken before the pandemic to those taken from March 15 to May 14, 2020. The urine samples came largely from people undergoing substance abuse treatment or were prescribed opioids and other controlled substances, and are not representative of the population at large.

Interestingly, while the rate of drug misuse remained largely the same before and during the pandemic – about 49 percent – there were notable shifts in the type of drugs being misused.

Drug positivity rates increased by 44% for heroin and 35% for non-prescribed fentanyl, a synthetic opioid that is 50 to 100 times more potent than morphine. Positivity rates for non-prescribed opiate medication (hydrocodone, hydromorphone, codeine and morphine) rose by 10 percent. There were no significant changes in the misuse of oxycodone and tramadol. 

Fentanyl was frequently found in urine samples that tested positive for amphetamines (89%), benzodiazepines (48%), cocaine (34%), and opiates (39%). The abuse of multiple substances in combination with fentanyl has been a growing problem for years, but Quest researchers were surprised by how much it has accelerated.

“It’s shocking that something could move that quickly. It’s been well underway for half a dozen years, but the pandemic supercharged it,” Kaufman told PNN.

Gabapentin Misuse

One surprising detail in the Quest study is that the nerve drug gabapentin (Neurontin) is being misused more often than any other prescription drug. Non-prescribed gabapentin was found in nearly 11% of urine samples — second only to marijuana — in the first two months of the pandemic. While that’s down from pre-pandemic levels, it adds to a growing body of evidence that gabapentin is being overprescribed and abused.

POSITIVITY RATES FOR NON-PRESCRIBED DRUGS (MARCH-MAY 2020)

SOURCE: QUEST DIAGNOSTICS

Gabapentin was originally developed as an anti-convulsant, but it has been repurposed to treat chronic pain and is often prescribed off-label as an alternative to opioids. When taken as prescribed, there is little potential for gabapentin to be misused. However, when taken with muscle relaxants, opioids or anxiety medications, gabapentin can produce a feeling of euphoria or high.

A likely factor in the decline in gabapentin misuse during the pandemic is a drop in physician visits. Fewer visits mean fewer prescriptions, and gabapentin may have become less available for diversion.

Just as stay-at-home orders forced many patients to cancel or postpone healthcare appointments, it also led a significant decline in drug testing. Orders for lab tests by Quest dropped by as much as 70% in the first few weeks of the pandemic. They have since rebounded, but are still well below pre-pandemic levels.

“COVID-19 interrupted non-essential patient care, but it hasn’t stopped drug misuse,” co-author Jeffrey Gudin, MD, Senior Medical Advisor to Quest, said in a statement. “Given the psychological, social, and financial impacts of the COVID-19 crisis, more efforts are needed to ensure that patients are taking medications as prescribed. While the nation focuses on the pandemic, we must not lose sight of the ongoing drug misuse epidemic, which continues to kill upwards of 70,000 Americans each year.” 

After briefly declining in 2018, drug overdoses began rising again in 2019. According to one preliminary study, drug overdoses are up about 17 percent so far this year.

FDA Designates First Virtual Reality Device for Chronic Pain

By Pat Anson, PNN Editor

AppliedVR, a Los Angeles-based virtual reality company, has announced that its EaseVRx headset has received Breakthrough Device Designation from the Food and Drug Administration for treating fibromyalgia and chronic intractable low back pain.

EaseVRx is the first virtual reality (VR) device to get a Breakthrough Designation from the FDA for treating a chronic pain condition. The designation speeds up the development and review of new medical devices that treat life-threatening or irreversibly debilitating diseases or conditions. It could also speed up insurance coverage of VR therapy for chronic pain.

“AppliedVR is the most evidence-backed VR platform on the market, and today’s FDA designation demonstrates that health experts across the spectrum recognize the therapeutic potential of VR as a viable treatment for pain,” Matthew Stoudt, CEO and co-founder of AppliedVR, said in a statement.

“Now, with the COVID-19 pandemic severely disrupting Americans’ ability to get in-person care safely, we’re looking forward to getting EaseVRx into the hands of people suffering from pain. Providers believe in it, patients want it, and payers are coming around to it.” 

AppliedVR funded a recent clinical trial that showed VR therapy can be self-administered at home to treat chronic pain. Patients living with fibromyalgia or chronic lower back pain were given VR headsets and instructed to watch at least one virtual reality program daily for 21 days.

The programs immerse users in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery. The goal is to help patients learn how to manage their pain and other symptoms by distracting them and making their pain seem less important

At the end of the study, 84 percent of the patients reported they were satisfied with VR therapy. Their pain intensity was reduced an average of 30 percent. Physical activity, mood, sleep and stress levels also improved.

“Virtual reality is a promising skills-based behavioral medicine that has been shown to have high patient engagement and satisfaction,” said Beth Darnall, PhD, AppliedVR’s chief science advisor. “However, chronic pain patients to date have had very limited access to it, so we’re excited to continue working with the FDA to develop our platform and get it into the market faster.”

PNN columnist Madora Pennington, who lives with chronic pain from Ehlers-Danlos Syndrome, recently reviewed one of AppliedVR’s headsets. She said watching VR programs helped calm and relax her.

“The benefits of VR therapy continued for me after the sessions ended. When pain or panic about pain began to set in, I found it drifts away rather than latching onto me like it used to,” Madora wrote. “After a couple weeks of VR, during a visit to physical therapist, I noticed I was no longer afraid of her touching my neck and back, and actually enjoyed it.”

AppliedVR’s technology is being used in hundreds of hospitals, but is not expected to be available for home use until next year. The company is working with Geisinger Health and Cleveland Clinic on two studies to see if VR therapy can be used as an opioid-sparing tool for acute and chronic pain.

VR for Phantom Limb Pain

Virtual reality technology received another boost this week when the Department of Defense awarded Chicago-based Coapt a $2.3 million grant to develop virtual reality therapies for phantom limb pain. Wounded veterans and amputees who have lost arms or legs often suffer from nerve pain and other sensations from their missing limbs.

"Phantom limb pain is a serious and persistent challenge for many upper and lower-limb amputees, and new, technology-based therapies have incredible promise," Blair Lock, co-founder and CEO of Coapt, said in a statement. "Preliminary work has shown that VR-based, actuated therapy can manage pain more effectively and have lasting effects. This grant will allow us to further study this therapy and bring to market a solution for those suffering from phantom limb pain in a way that also happens to be engaging."

Coapt has previously developed a VR-based therapy to help upper-limb amputees improve control of their prostheses. The technology also shows promise as a treatment for phantom limb pain. Coapt will use the grant money to further study the effectiveness of VR therapy and create a commercially viable product for both civilians and veterans with upper and lower-limb amputations.

Migraine and Arthritis Patients Report More Pain During Pandemic

By Pat Anson, PNN Editor

Two new surveys are opening a window into how migraine and arthritis patients are managing their pain and getting treatment during the coronavirus pandemic. Many remain fearful about visiting a provider and want insurers to make access to medication easier.

The first survey, conducted by the Headache & Migraine Policy Forum, found a significant increase in stress and migraine attacks in over 1,000 U.S. migraine patients who were surveyed over the summer.

Asked how COVID-19 had impacted their health and treatment, over two-thirds (69%) of patients said they were experiencing an increase in monthly migraines. Eight out of ten (84%) said they felt more stress managing their disease (84%) and over half (57%) said their overall health had worsened.

“Treating a debilitating condition like migraine disease during a global pandemic can increase stress for patients, many of whom already struggle with day-to-day activities. Added stress can mean more frequent attacks, resulting in more visits to see a health care provider or even costly ER visits,” the Policy Forum said.

But while the frequency of migraine attacks increased, many patients were reluctant about seeing a provider and potentially exposing themselves to COVID-19. Six out of ten (61%) said they were afraid to seek care at a doctor’s office or hospital, and 74% were hesitant to visit an emergency room when having an acute migraine attack.

Some insurers have relaxed rules about prior authorization and step therapy to make access to medication easier during the pandemic. But most migraine patients say their own insurers need to be more flexible.

• 72% had difficulty managing their migraine because they couldn’t get a longer supply of medication

• 73% said insurers did not allow them to get more medication per pharmacy fill

• 70% said insurers did not reduce barriers like prior authorization

• 76% said insurers did not stop requiring step therapy

While migraine patients were often unhappy with their insurers, most were delighted with telehealth. The vast majority (83%) said they hoped their providers continued using telehealth after the pandemic ends.

“COVID has introduced a host of new challenges for people living with migraine disease. Telemedicine clearly provides an important link to care, but patients are looking for insurance providers to do more to facilitate care, including cutting red tape and ending delay tactics,” Lindsay Videnieks, Executive Director of the Headache & Migraine Policy Forum said in a statement.

Arthritis Patients Want New Treatments

The second survey of nearly 2,000 adults suffering from osteoarthritis had similar findings. Over a third of respondents (37%) told the Arthritis Foundation that they had missed or cancelled a doctor’s appointment due to fear of COVID-19 infection. Only 15% said their osteoarthritis is well managed.

Osteoarthritis (OA) is a joint disorder that leads to thinning of cartilage and progressive joint damage. No disease-modifying drugs are currently available to treat OA, and over the counter pain relievers have only mild to moderate effects on OA pain.

"Pain is debilitating. My back and hip pain are so bad that I have trouble getting out of bed," said one survey respondent. "Each step is excruciating, and I wonder how much longer I can deal with the pain."

"You spend a lot of time & effort trying not to think about it because what you focus on magnifies," another patient wrote. "You hate pain scales because how do you rate something that is always there? Oftentimes it's not the pain's intensity but rather the duration."

Nearly two-thirds (65%) of patients said they use non-steroidal anti-inflammatory drugs (NSAIDs) or topical medication to manage their pain, 29% use physical therapy or massage, and another 29% said total joint replacement helped.

The primary change OA patients want is for insurers to increase coverage of new arthritis treatments, though more than half said they were only interested in a new treatment for pain if it didn't also increase their joint damage.

The Arthritis Foundation recently joined with 30 other healthcare organizations in asking the Food and Drug Administration and National Institutes of Health to make the development and availability of pain treatments a higher priority within the agencies.

Reduced Drinking Can Improve Pain Symptoms

By Pat Anson, PNN Editor

It’s no secret that alcohol consumption has risen sharply during the coronavirus pandemic, as more people are drinking to cope with anxiety, loneliness, stress and boredom. According to recent research published in JAMA Network Open, alcohol sales rose 54% in the first weeks of the pandemic, and there was a significant increase in heavy drinking among women.

Excessive alcohol use may worsen mental and physical health problems, and it is particularly problematic for people with chronic pain, who are often prescribed medications that shouldn’t be taken with alcohol.

Another reason to reduce drinking is that it could improve your pain symptoms, according to a recent study of U.S. military veterans published in Alcoholism: Clinical and Experimental Research. The study followed about 7,000 veterans who took annual surveys between 2003 and 2015 that included questions about their mental health and alcohol and substance use.

Researchers identified about 1,500 veterans who reported heavy drinking in at least one survey, and then compared those who reduced their alcohol consumption to those who did not.

The veterans who reduced their drinking were more likely to have improved pain symptoms two years later, and had higher odds of stopping smoking, cannabis, or cocaine use. There was no noticeable improvement in their depression and anxiety.

“We found some evidence for improvement of pain interference symptoms and substance use after reducing drinking among US veterans with unhealthy alcohol use, but confidence intervals were wide,” wrote lead researcher Ellen Caniglia, an epidemiologist in the NYU School of Medicine in New York City.

Caniglia and her colleagues noted that the timing of alcohol reduction relative to improvement in pain and other conditions was often unknown, so it cannot be concluded that less drinking caused the improvement or vice versa.

The veterans included in the study were not representative of the overall population; nearly half had moderate to severe chronic pain, more than half had anxiety, a third had depression, and half were HIV-positive. More than two-thirds were tobacco smokers, a third reported cannabis use, and another third reported cocaine use.

That said, researchers say their findings support efforts to reduce drinking in veterans with unhealthy alcohol use, and suggest that reduced drinking is unlikely to worsen pain symptoms or increase the abuse of other substances.

Some previous studies have found that moderate alcohol consumption may actually improve pain symptoms. A 2015 survey of over 2,200 people with fibromyalgia and other chronic pain conditions found that drinkers reported significantly less disability than teetotalers.

And a 2017 analysis published in the Journal of Pain found “robust evidence” that a few drinks can produce a “moderate to large reduction in pain intensity.”

How much is too much? According to the Mayo Clinic, moderate alcohol consumption for healthy adults means one drink a day for women of all ages and men older than age 65, and two drinks a day for men age 65 and younger.

Great Progress Being Made in Treating Arachnoiditis

By Dr. Forest Tennant, PNN Columnist

About 5 years ago, most medical practitioners had either never heard of Adhesive Arachnoiditis (AA) or thought it was a spider bite. Today, almost all practitioners in the modern world have heard of AA. Many now understand it and some even treat it. A few are trying some innovative new approaches.

AA is a chronic inflammation that starts inside the spinal canal that can lead to severe suffering, neurologic impairments and a shortened lifespan. Once inflammation starts, it apparently never, or rarely, goes totally away.  

Treatment and prevention in recent years have greatly reduced the occurrence of some serious neurologic impairments and autoimmune complications of AA. The most obvious decrease in new cases reviewed by the Tennant Foundation are those of upper and lower extremity paraparesis (partial paralysis) and total paralysis, which are rapidly disappearing.

Urinary and bladder impairments that require catheterization are also hardly seen. And the autoimmune manifestations of arthritis, thyroid deficiency and carpal tunnel are disappearing.

Why the improvement? Awareness, thanks to patients, social media and advocates who have educated the medical profession about AA. Fewer epidurals, early treatment and emergency measures have all helped. The development of protocols for prevention, emergency intervention and on-going treatment have been essential.

Major Remaining Problems

Persons with AA are still having difficulty, in some communities, finding medical practitioners who are comfortable and willing to treat AA. The major complication is the development of constant pain and the intractable pain syndrome.

The key to preventing AA and stopping its progression is early treatment. Our research has clearly shown that AA is almost always preceded by one of 3 intraspinal canal inflammatory conditions:

1. Protruding, degenerated intravertebral discs.

2. Cauda equina inflammation.

3. Arachnoid inflammation (i.e. plain arachnoiditis) due to collagen disorders or needle injury.

Some intraspinal canal inflammatory disorders always precede AA. These disorders should be aggressively treated to prevent AA.

Select Corticosteroids Essential for AA

We believe all persons with typical AA symptoms and documentation of the disease on an MRI must take one of two corticosteroids (CS): methylprednisolone or dexamethasone for the spinal canal inflammation and pain of AA.

Currently there is no other medication agent that consistently and predictably suppresses intraspinal canal inflammation and reduces pain. Do not expect to halt progression or have much recovery if you do not consistently take a CS.

Dexamethasone and methylprednisolone are the preferred CS’s because they cross the blood brain barrier, enter spinal fluid and act on glial cells. Prednisone and hydrocortisone are not as consistently effective as dexamethasone and methylprednisolone, which should be taken in low doses.

1. Maintenance-low dose of dexamethasone (.5 to .75mg) or methylprednisolone (Medrol) 2 to 4 mg on 2 to 5 days a week. Skip days between dosages. An alternative is a weekly or bi-monthly injection of methylprednisolone or dexamethasone. Injections are usually the answer to corticoid sensitivity or gastric upset.

2. For flares, a 6-Day Medrol Dose Pak or an injection of methylprednisolone or dexamethasone, preferably mixed with a standard dose of injectable ketorolac.

The fear of corticosteroids comes from daily use of high doses, not from low, intermittent dosages. Some persons with severe asthma and rheumatoid arthritis must take a corticosteroid for years and don’t experience serious side effects.

Forest Tennant, MD, MPH, DrPH, is retired from clinical practice but continues his groundbreaking research on the treatment of intractable pain and arachnoiditis. This column is adapted from bulletins recently issued by the Arachnoiditis Research and Education Project of the Tennant Foundation. Readers interested in subscribing to Dr. Tennant’s bulletins should send an email to tennantfoundation92@gmail.com.

Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.  

Can Herd Immunity End the Pandemic?

By Roger Chriss, PNN Columnist

The latest round in the ongoing public health debate over the pandemic pits two online petitions against each other: the "Great Barrington Declaration" versus the “John Snow Memorandum.” The former focuses on natural herd immunity, while the latter emphasizes controlling community spread through lockdowns, masks and other public health measures.

The Barrington Declaration has garnered support from the Trump administration because it calls for schools and businesses to reopen, and for life to return to normal for “those who are not vulnerable” to the virus.

“The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk. We call this Focused Protection,” the Declaration states.

The John Snow Memorandum, named for the famed British physician who halted the 1854 London cholera outbreak, states that "Any pandemic management strategy relying upon immunity from natural infections for COVID-19 is flawed. Uncontrolled transmission in younger people risks significant morbidity and mortality across the whole population."

The Declaration’s Fundamental Flaws

The Declaration claims that “all populations will eventually reach herd immunity – i.e. the point at which the rate of new infections is stable – and that this can be assisted by (but is not dependent upon) a vaccine.”

But we do not know this. Many diseases, from malaria to Ebola, continue to rip through populations without reaching herd immunity. It is entirely possible that Covid-19 will reach a similarly perilous “equilibrium,” becoming endemic until the arrival of a vaccine. At this point we don’t know enough about the coronavirus SARS-CoV-2 to make any strong claims that herd immunity will “eventually” happen.

Moreover, the “Focused Protection” championed in the declaration assumes that we have adequate testing, contact tracing and isolating to protect the vulnerable, though at present the U.S. does not. It further assumes that Covid-19 doesn’t have a significant disease burden, even though there is mounting evidence that the disease can cause considerable and long-lasting harm in otherwise healthy adults and children.

The Declaration assumes that durable immunity to the virus results from infection. But there are a handful of documented cases where reinfection has occurred, such as a 25-year old Nevada man who became seriously ill during his second bout with Covid-19.  It’s not clear how “durable” immunity is.

As Yale immunologist Akiko Iwasaki explains in a recent commentary in The Lancet, “reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity; not only is this strategy lethal for many but also it is not effective."

The experiences of Arizona, Florida and Texas over the summer show that “Focused Protection” doesn’t work in the real world. All three states were hit hard during the summer surge, with hundreds of thousands of cases and tens of thousands of deaths. As we head into the fall, we’re now seeing a surge of new cases in the upper Midwest.

The Memorandum’s Practical Challenge

The John Snow Memorandum states that “controlling community spread of COVID-19 is the best way to protect our societies and economies until safe and effective vaccines and therapeutics arrive within the coming months.”

This is credible, given the experiences of Germany, New Zealand, South Korea and other nations that managed to control virus spread and minimize death and disease through a mixture of public health measures. They created national plans for testing, tracing and isolating, and with consistent public health messaging that minimized socioeconomic disruption. Lockdowns were not always necessary, either. Japan avoided a national lockdown, instead controlling spread with strong public health measures.

The United States, by contrast, has failed to do these things. We are not generally good at public health, as the worsening opioid overdose crisis has clearly shown. The failures in the overdose crisis were arguably prologue for the uncoordinated and undisciplined approach the U.S. has taken to the pandemic.

The Memorandum’s recommendations are laudable, but they will be hard to implement, even though current projections suggest over 170,000 more deaths and millions of new cases of Covid-19 in the coming months.

The U.S. needs to ask itself two questions. First, how did we get to a point where the Great Barrington Declaration even sounds like a good idea? Second, what can we do to find a better way forward, as suggested by the John Snow Memorandum, to avoid additional deaths and disease? Winter is coming and the coronavirus will have the run of the country unless we step up to stop it.

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. 

Are You Living in the Matrix?

By Dr. Lynn Webster, PNN Columnist

A recent Netflix documentary, "The Social Dilemma," illustrates how social media networks are selling each of us as commodities to advertisers. Tristan Harris, a former Google employee, points out that platforms such as Reddit, Facebook, Twitter and Instagram make money by allowing advertisers to target members who are interested in their products or services.

That means anyone who uses "free" social media are not just consumers. We are the products being sold.

We’re allowing our brains to be manipulated by sophisticated marketing and artificial intelligence (AI) designed to change our behavior. Each time we “like” something or stay on a web page for more than a second, we provide technology companies with additional knowledge about who we are and what makes us tick. Each click helps AI become better at manipulating us, deciding what we see and what we don’t.

Because the things that fill one person's newsfeed may never make their way into another’s, social media networks shape our version of reality while they polarize society. Unfortunately, “fake news” is sometimes more profitable to advertisers than real news. We have segued from living in the Information Age to subsisting in the Disinformation Age. This is especially frightening when we see how much influence conspiracy theories have in our culture today.  

According to the documentary, we have essentially isolated ourselves in a bubble of technology. Loneliness and depression are rampant in our society, and people interact less in the real world than they do online. When others "like" our posts, we get a hormonal rush of chemicals -- and when it dissipates, we crave another hit. The need for approval and belonging keeps us clicking.

As "The Social Dilemma" asks, "How do you wake up from the matrix when you don't know you are in the matrix?"

People with Pain Live in the Matrix, Too

The online audience for messages has become fragmented for people with different views. This limits the reach of any particular message to those who share the same beliefs or problems. That puts people living with pain who reach out to others through social media at a disadvantage they may not even understand.

The documentary makes the point that the only industry besides social media that uses the term “users” is the illicit drug world. People living with pain or addiction are vulnerable to the same dopamine rush that keeps us clicking to receive affirmation from others who share our experiences.

People in pain desperately want to be heard by people who can help them. But, because of AI, only those who already tend to be supportive of people in pain are likely to see their posts.

The very nature of chronic pain and addiction narrows people’s worlds. So does social media. It has a compounding effect. As a society, we need to understand that our world becomes narrower with each click.

Think of those you unfriend or the people who block you on social media. They are the ones you need to hear from, because they are people who have different views from yours. It may feel comfortable to stay within your own lane, but that won't help if your goal is to understood the world and help change it for the better.   

Bursting Your Information Bubble

There are general principles we can all use to sort the truth from the lies on the internet. One is to recognize that if you have a strong emotional response to an online message, you may have become the successful target of manipulation. Take a deep breath and tell yourself the manipulators found a way to trigger your dopamine release. Remember that the message you saw may be only partially true -- or not true at all.

Before you share a post or believe it yourself, verify the source. Check out the veracity of the story on Snopes or some other fact checker. Seek out sources other than those that appear in your timeline or on your news feed. Instead of trusting your search engine, proactively log onto news sites with opposing viewpoints.

If the stories you find feature quotes, go to the original source and see if the message was taken out of context. The greater your emotional reaction to the message, the greater the chances are that it is inaccurate, misleading information.

“The Social Dilemma” website offers a toolkit to “realign your relationship with technology” and explore these issues -- including what social media is doing to our democracy -- more deeply.

We can't ban the internet. We wouldn't want to, even if we could. There are obvious benefits to digital communication, and we can't put the genie back into the bottle.

However, if we don’t want to be trapped in a dystopia where humanity is controlled by a manipulated reality, we have to realize that "free" online services are anything but that. The cost is the truth. When we sacrifice a balanced view of the world because of our desire to belong, we risk locking ourselves in the matrix. 

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 Lynn on Twitter: @LynnRWebsterMD. 

Study Finds Most Drugs Ineffective for Neuropathic Pain

By Pat Anson, PNN Editor

A first of its kind study that compared four medications widely used to treat neuropathy found that all four were usually ineffective in treating pain and many patients stopped taking them due to side effects.    

Over 20 million people in the U.S. suffer from neuropathic pain, a tingling, burning or stinging sensation in the hands and feet caused by nerve damage. Neuropathy is often caused by diabetes, chemotherapy or trauma, but in about 25% of cases the cause is unknown and classified as cryptogenic sensory polyneuropathy (CSPN).

There is little guidance for physicians and patients on what drugs to take for CSPN, so researchers at the University of Missouri School of Medicine conducted a “real world” study in which 402 patients with CSPN took one of the four neuropathy medications.

The four drugs studied were nortriptyline (Aventyl), a tricyclic antidepressant; duloxetine (Cymbalta), a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant; pregabalin (Lyrica), an anti-seizure drug; and mexiletine (Mexitil), an anti-arrhythmic medication used to treat irregular heartbeats.

Nortriptyline, duloxetine and pregabalin are approved by the FDA for treating neuropathy, while mexiletine is used off-label. None of the drugs were originally developed to treat neuropathic pain.

"As the first study of its kind, we compared these four drugs in a real-life setting to provide physicians with a body of evidence to support the effective management of peripheral neuropathy and to support the need for newer and more effective drugs for neuropathic pain," said lead researcher Richard Barohn, MD, executive vice chancellor for health affairs at the University of Missouri.

After 12 weeks of use, any drug that reduced pain for a patient by at least a 50% was considered effective, a recognized industry standard to define therapy success.. Researchers also kept track of patients who stopped taking a drug and dropped out of the study due to adverse effects.

The study findings, published in JAMA Neurology, can best be described as underwhelming. Patients were far more likely to stop taking a drug than they were to stay on a medication that was helping them.    

Of the four drugs, only nortriptyline was an effective pain reliever for at least 25% of patients. It also had the second-lowest drop-out rate (38%), giving it the highest level of overall utility. Duloxetine had the second-highest efficacy rate (23%) and the lowest drop-out rate (37%).

Pregbalin had the lowest efficacy rate (15%) and the second highest drop-out rate (42%), while mexiletine had the highest drop-out rate (58%) and an efficacy rate of 20 percent.

EFFICACY RATE OF NEUROPATHY DRUGS

SOURCE: JAMA NEUROLOGY

"There was no clearly superior performing drug in the study," Barohn said. "However, of the four medications, nortriptyline and duloxetine performed better when efficacy and dropouts were both considered. Therefore, we recommend that either nortriptyline or duloxetine be considered before the other medications we tested."

While nortriptyline had the highest efficacy rate, it also had the highest rate of adverse events, with over half of patients (56%) reporting side effects such as dry mouth, drowsiness, fatigue and bloating.  

Previous studies have found that duloxetine and pregabalin had higher efficacy rates for neuropathic pain, but Barohn and his colleagues say their research more accurately reflects what patients experience in real life and what physicians encounter in their practice.

“Our findings could affect how these 4 drugs are used by all physicians who treat patients with neuropathy. Findings support duloxetine and nortriptyline as better-performing drug choices in this population with neuropathic pain, suggesting that they should be prescribed before pregabalin or mexiletine are considered. However, this study also supports a finding that all 4 drugs helped improve pain in at least some patients, so each could be tried if others failed,” they concluded.     

There are several other drugs used to treat neuropathy, including gabapentin, venlafaxine and sodium channel inhibitors. Barohn says additional comparative studies should be performed on those drugs. His goal is to build effectiveness data on nearly a dozen drugs for CSPN.

Lancet Study Calls for Improvements in Pediatric Pain Care

By Pat Anson, PNN Editor

An international study by The Lancet has found that childhood pain often goes untreated, unrecognized and poorly managed, leading to chronic pain, disability and other negative consequences in adulthood.

The report by the Lancet Child and Adolescent Health Commission, led by the Centre for Pain Research at the University of Bath, found that too many children live with pain — even in developed countries — and calls for improvements in pediatric pain care, including diagnosis, pain management, social support and psychological treatment.

"Among health-care professionals, it is easy to agree that no child should experience pain if that pain can and should be prevented, avoided, or successfully treated,” said lead author Emma Fisher, PhD, a Versus Arthritis fellow at the University of Bath.

“In practice, however, we know there is ample evidence that children frequently experience preventable pain, and that in high-income settings, with advanced health-care systems and highly educated and regulated health professionals, children and young people experience pain that often goes unnoticed, unreported, or is not responded to, across healthcare including in the Emergency Department, post-surgical care, and in tertiary care.”

Childhood Pain ‘Swept Under the Carpet’

The report provides several examples of childhood pain not being recognized or treated adequately, such as what happened to Caitriona Roberts of Belfast, Northern Ireland. At age 12, she went to her doctor with pain and swelling in her ankle. Initially written-off as 'just a sprain' that would go away, she would spend the next six months living in almost constant pain, until she was referred to a specialist who diagnosed her with juvenile idiopathic arthritis, an autoimmune condition.

Now 28, Roberts has learned how to live and manage the disease. She helped researchers prepare The Lancet report.

"I think this issue has been swept under the carpet for too long. Still today, over 15 years on from my diagnosis with arthritis, I find people, including medical professionals, unaware of the condition or its effects on my day-to-day life. And when I speak to other young people, I find that sadly, very little seems to have changed in terms of how they experience pain or the support they receive,” Roberts said.

Researchers say up to 10% of young people experience chronic pain into early adulthood, with conditions such as arthritis, other types of musculoskeletal pain, recurring abdominal pain, and headaches.  

"This really matters, both for those experiencing pain and those around them but also across wider society. We know that chronic pain experienced in childhood is likely to feed through to adulthood and this has long-term health and economic costs associated,” said Fisher.

She called on providers and policymakers “to sit up and listen to the fact that too many of our young people are in pain and need help."

Myths About Opioids

One obstacle to getting that help is the stigma associated with opioid pain medication, particularly in the United States and Canada, where researchers say guidelines intended to control opioid use in adults are being “inappropriately applied to young people.”

“Substance use disorders and pain medication are both conflated in policy and in the media's portrayal of the North American opioid crisis,” the report found. “Through this media, public views have been influenced to consider opioids as drugs of addiction rather than pain medicine.  

“Health-care professionals, young people, and parents continue to hold misconceptions and believe myths about opioid use in pediatric patients, whereby the media depicts opioids as the villain and the underlying reason for substance misuse. Opioids have their place in pediatric pain medicine. In the context of the oversupply of opioids, childhood pain can usefully be considered a risk factor for long-term harmful exposure to opioids.”

More Than Growing Pains

The report found that improvements in pediatric pain care have come slowly. The last major intervention in the field came in the 1980’s, when it was recognized for the first time that babies experienced pain. Up until that point, a number of routine and major operations, including heart surgery, were carried out on babies without anesthetics.

"Parents tell us about the struggle they have convincing their GP that their child's illness is more than growing pains,” said Zoe Chivers, Head of Services at Versus Arthritis, which funded the report. “While the focus, attention, and dedication in providing quality services to children is consistently in place for conditions like cancer it's woefully absent for childhood arthritis and chronic pain.

"As a society we need to understand that dismissal of arthritis comes at high price and that adults and children living in pain with the condition should no longer be expected to pay it."

The study has four key goals: to make childhood pain matter, to make it understood, to make it visible, and to make it better. One recommendation is to make routine vaccinations less painful and stressful for children, such as allowing parents to be present during the injections and using topical analgesics.

"For many parents and children, a trip to the doctors for routine inoculations will be a stressful and painful experience. This does not have to be the case - we know how we can make the experience less painful for young people, but we're not doing it. This is just another example of how pain has been accepted as an everyday feature of growing up," said Fisher.

‘Partial Fill’ Rule for Pharmacies Would Harm Pain Patients

By Pat Anson, PNN Editor

A retired Nevada pharmacist who lives with chronic back pain is warning that patients will suffer if the Drug Enforcement Administration enacts a rule that allows pharmacists to only partially fill opioid prescriptions.

The DEA is under pressure from Sen. Elizabeth Warren (D-MA) and other members of Congress to stop “foot-dragging” and finalize a regulation that would allow patients to take home only part of their opioid prescription. They would have to return a second time to get the rest.

“I think it (the DEA partial refills) would have a huge impact on patients who regularly get their pain meds filled. Can you just imagine people already in pain having to go back to their pharmacy again to get the balance? Going once a month is already problematic for many. Twice a month would be inhumane,” Rick Martin said in an email to PNN.

“Pharmacists might not like it either because it would make them have to account for their inventory more often and maybe double the amount of work to fill the same Rx again.”

Warren, along with Sen. Dianne Feinstein, Sen. Shelley Moore Capito, Rep. Kathleen Clark and Rep. Steve Stivers, sent a bipartisan letter to acting DEA Administrator Timothy Shea last week urging him to update the “partial fill” regulation, as required under the 2018 Comprehensive Addiction and Recovery Act (CARA). 

“DEA has failed to issue its proposed rule, despite assurances in recent years that ‘this proposed rule is a top priority’ for the agency,” the letter says. “Defining ‘partial fill’ and fully implementing Section 702 of CARA will reduce the number of prescription opioids in circulation, a crucial step in addressing the opioid crisis that is devastating communities across the country. DEA’s continuing foot-dragging on this issue puts Americans at risk.”

Warren and her colleagues asked the DEA to provide an update and staff-level briefing on the matter no later than October 20.

Under current rules, the DEA only allows pharmacists to do a partial fill if they don’t have enough medication on hand to completely fill a prescription – something that many patients say is already happening. In a report issued earlier this year, the DEA said the supply of prescription opioids was at its lowest level since 2006.

“Once again, the letter just shows a bunch of busy-body ignorant uneducated senators sticking their nose where it doesn't belong,” said Martin. “They (pharmacists) shouldn't be doing this unless they don't have an adequate amount to fill or unless the patient gives them permission to partial fill.”

The Warren letter claims over half of those who abuse opioid medication obtain it from a friend or family member. The DEA, however, has said less than one percent of opioids that are legally prescribed are diverted.

Illicit fentanyl, heroin and other street drugs are responsible for the vast majority of overdoses. A 2019 study of overdoses in Massachusetts – Warren’s home state – found only 1.3% of overdose victims had an active opioid prescription.  

Doctor Who Lost Medical License Leading Effort to Sue Kolodny

By Pat Anson, PNN Editor

Pain patients and their supporters are planning to rally Wednesday at Brandeis University in Massachusetts, a protest against Dr. Andrew Kolodny, a senior scientist at Brandeis who co-directs opioid research at the Heller School for Policy and Management.

Kolodny is the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group that has led efforts to reduce opioid prescribing in the U.S. Many patients blame PROP for their poorly treated or untreated pain, as well as increased suicides in the pain community. The so-called “Killer Kolodny Rally” is being organized by Claudia Merandi of the Don’t Punish Pain rally organization.

“If we in the pain community want to make changes, we have a lot of work to do. We have been damaged severely. And Kolodny’s largely responsible,” says Dr. Arnold Feldman, a retired anesthesiologist who is working with Merandi to raise money for a possible class action lawsuit against Kolodny,

As PNN first reported, Kolodny and PROP played influential roles in drafting the CDC’s controversial 2016 opioid prescribing guideline. Kolodny is also a well-paid expert witness in opioid litigation cases.

“Kolodny is enriching himself to a very large degree,” Feldman told PNN. “Every day I am finding weblike connections between Kolodny and pharmaceutical manufacturers.”

Feldman and some patient advocates have claimed — without offering any proof — that Kolodny has benefited financially from promoting addiction treatment drugs like Suboxone.

The allegation led Kolodny to ask for and receive a letter from Indivior, Suboxone’s manufacturer, stating that he does not have a financial interest in the company and has received no payments from it as a consultant, speaker or in any other capacity.    

Nevertheless, Feldman claims that he has evidence of Kolodny’s culpability and will be able to uncover more once a class action lawsuit is filed.  He and Merandi have not been able to find a law firm willing to take the case.

DR. ARNOLD FELDMAN (YOUTUBE IMAGE)

“I’ve got lots of evidence. I’m not going to put it out in public because we’re going to need this in our case,” Feldman said. “Unfortunately, I’m not a stranger to lawyers.”

Medical License Suspended

Feldman has indeed fought and lost a number of legal battles, including an unsuccessful effort to get his medical license back after it was suspended in 2016 by Louisiana’s Board of Medical Examiners. The disciplinary action came after a patient died three years earlier while getting an epidural steroid injection at Feldman’s surgery clinic in Baton Rouge.

Feldman was charged with seven counts of negligence and unprofessional conduct, such as allowing an unlicensed and unsupervised employee to insert an IV into the patient and give him medication. The patient went into cardiac arrest during the procedure and Feldman was unable to revive him. 

“I had a patient who passed away. Not from anything I did. He had a cardiomyopathy and passed away. They tried to get me for that. But they couldn’t because the autopsy said he died from natural causes,” Feldman told PNN.

The state medical board felt otherwise and accused Feldman of a coverup, saying he gave investigators a “quite staggering” amount of false records and testimony about what happened.

“Dr. Feldman failed to adequately monitor the patient, exercised poor management or care of the patient after complications arose, and all of his resuscitation attempts were contributing factors to the patient’s death,” the board said in its ruling.

Feldman’s clinic had previously been cited in 2010, 2011 and 2013 for not following safety standards, putting patients in “immediate jeopardy” of injury and death.

Investigators also said Feldman allowed his employees to forge his signature and sign opioid prescriptions, and that he gave pre-signed prescriptions to patients without seeing them.

Feldman says he was denied due process by the medical board and appealed his suspension twice in court, but it was upheld both times.

“Dr. Feldman failed to adequately monitor the patient, exercised poor management or care of the patient after complications arose, and all of his resuscitation attempts were contributing factors to the patient’s death.”

— Louisiana Board of Medical Examiners

Because of the disciplinary action in Louisiana, Feldman’s medical licenses were also suspended in California, Alabama and Mississippi. Feldman had previously been reprimanded and put on probation by Mississippi’s medical board in 2000 after he “violated numerous laws and regulations” involving the prescribing, dispensing and administration of controlled substances.

In 2017, the Drug Enforcement Administration effectively ended Feldman’s career by revoking his DEA license to prescribe opioids and other controlled substances.   

No longer able to practice medicine, Feldman lost his home, car and clinic, and for a time lived in a motor-home, according to testimony he gave at a legislative hearing. He now lives in Florida. Feldman says he could have his medical license reinstated in Louisiana, but it would cost $460,000 that he doesn’t have.

‘I Know Pain Management Better Than Anyone’

Although he hasn’t practiced medicine in years, Feldman still considers himself an expert in pain management because he “learned skills that nobody else had.”

“I know this business, meaning pain management, better than anyone living. I’m a surgeon. I’ve done disc surgery. I’ve done pain pumps, (spinal cord) stimulators, and 100-thousand nerve blocks. I know what’s going on,” he said. “Most of these pain conditions are incurable, and I’ll tell you what, half of them are created by the medical profession.”

Since his forced retirement, Feldman has become something of a gadfly in the pain and legal communities, joining with another doctor whose medical license was revoked in filing a $28,000 trillion lawsuit against the Federation of State Medical Boards, the American Medical Association and other entities.

Feldman and Merandi have established a non-profit called The Doctor Patient Forum to advocate for doctors in legal jeopardy and pain patients who can’t get proper treatment. “He is brilliant. We work well together,” says Merandi.

The two have raised nearly $12,000 for the lawsuit against Kolodny, with most of the money coming in small donations from pain patients who know little or nothing about Feldman or how the money will be spent. 

“It’s in a bank account. I don’t touch it. I haven’t taken a dime. Nor will I ever. When we have enough money and find a law firm, that’s where the money will go,” he promised. 

“The only way to bring awareness to this is with litigation,” Merandi said in a recent radio interview. “We believe we have to bring Andrew Kolodny before a court of law. We have to bring the others before a court of law. We need an investigation done and that costs money.”

Legal experts say attorneys in class action lawsuits are typically not paid for their services and expenses unless they prevail in court. All payments have to be approved by a judge, with the money coming from the award or settlement — not the plaintiffs. Legitimate attorneys will not ask for upfront money in a class action case, according to consumer advocate Ron Burley.

Lawyers: ‘We Have Nothing To Do’ With Fundraiser for Kolodny Lawsuit

By Pat Anson, PNN Editor

The attorneys who filed lawsuits against three pharmacy chains for allegedly discriminating against pain patients are disavowing any connection with efforts to raise money for a proposed lawsuit against Dr. Andrew Kolodny, a prominent anti-opioid activist.

Dr. Arnold Feldman, a retired anesthesiologist, has a GoFundMe campaign underway to raise $100,000 for a class action lawsuit targeting Kolodny, the founder and Executive Director of Physicians for Responsible Prescribing (PROP). Feldman calls Kolodny an “anti-opioid zealot” who has harmed pain patients through his advocacy against opioid prescribing.

“To be clear, we have no involvement in or with any fundraising efforts by Dr. Feldman or others who may be associated with him or a possible lawsuit against Dr. Kolodny,” attorney Robert Redfearn, Jr. said in a statement to PNN. “Our focus and involvement is on and in the two national class action lawsuits that we filed in Rhode Island and California, through which we hope to bring some relief to pain patients.  Further, we have not received or accepted any funds from Dr. Feldman or others who may be associated with him.”

Feldman and his associate, Claudia Merandi, have claimed they were instrumental in filing the lawsuits against CVS, Walgreens and Costco on behalf of two pain patients. Merandi is one of the founders of the Don’t Punish Pain rally organization.

“BIG NEWS FOR PAIN COMMUNITY: We have filed class action lawsuit against CVS/WALGREENS for DENYING to fill opioid scripts. This will set a precedent as to why you DON'T PUNISH PAIN,” Merandi posted on Twitter when the lawsuits were filed in August.

“Dr. Feldman was successful in bringing a class action lawsuit against Walgreens and CVS to fruition and he will do the same for the Kolodny lawsuit,” Merandi posted to her followers on Facebook, sharing a link to the GoFundMe campaign.

“Fact: There's only a lawsuit filed against CVS and Walgreens because of Dr Feldman,” Merandi wrote in yet another tweet.

‘We Are Litigating This on Our Own’

But the lawyers who actually filed the lawsuits say Feldman and Merandi had nothing to do with their litigation, other than providing encouragement.

“In terms of their involvement, there is none. We are litigating this on our own,” said attorney Scott Hirsch. “We obviously don’t agree with Claudia’s stance that this is her lawsuit. It’s not. We’re representing the plaintiffs and the chronic pain community.”

Hirsch began working with Edith Fuog on her lawsuit against CVS in 2018, long before Merandi and Feldman were even aware of the case. He has been working without pay, which is usually the case in class action lawsuits. Attorneys are typically not paid until damages are awarded.

“We have nothing to do with any sort of fundraising that Claudia Merandi and Dr. Feldman are doing in terms of this lawsuit. There’s no fundraising that we’re doing or they’re doing for us or this Kolodny lawsuit. We have nothing to do with that. We’re not even interested in it, to be quite frank,” Hirsch said.

Hirsch, Redfearn and four other law firms are involved in the pharmacy lawsuits, which they hope will get class action status. If successful, the suits could potentially result in millions of dollars in damages being awarded to pain patients who were unable to get their opioid prescriptions filled.

“All these people came together and brought this lawsuit. It wasn’t just Dr. Feldman, he wasn’t the savior for us all. And that’s my issue. It’s not 100 percent truthful in her (Merandi’s) statement. There’s a lot missing,” Fuog told PNN. “I don’t know anything about what they’re doing with Dr. Kolodny. I don’t know who they are hiring. I don’t know where the funds are sitting until they hire a law firm. I don’t know the basis for the lawsuit that they want to file.”

So many misleading claims have been made that the six law firms representing Fuog and Susan Smith, who filed suit against Walgreens and Costco, have posted a disclaimer on their website disavowing any association with the GoFundMe campaign and Don’t Punish Pain.

“These groups on the internet, such as Don’t Punish Pain, have posted information about our lawsuits on their websites, Facebook, Instagram and other social media. This content is not affiliated with the lawsuits or our effort on behalf of chronic pain patients.

Please understand no organization except the affiliated lawyers and law firms handling these National Class Action Lawsuits are authorized to speak for us or make any financial or informational request on our behalf. In other words, please be advised that all other individuals or groups are NOT authorized to speak on behalf of us or the named plaintiffs in the lawsuits, NOT involved in the handling or prosecuting of the lawsuits, and NOT authorized to raise money to cover expenses associated with the lawsuits.”

Asked to clarify what role he played in the lawsuits, Feldman told PNN he “sounded the alarm” and alerted lawyers to what was happening to pain patients. He said his wife is among those who’ve had trouble getting their opioid prescriptions filled.

“I knew some lawyers and I said, ‘Guys, this is a problem. What do you think?’ And I harangued them and harassed them and called them and screamed at them,” Feldman explained.  “But I had nothing to do with it. I didn’t write the complaint. I didn’t file the complaint.

“I had nothing to do with this litigation. Nothing. Neither does Claudia. Other than the fact that we said we’re happy this has happened. That’s the extent of it.”

Merandi says she exchanged emails and participated in Zoom calls with the lawyers. And she continues to insist that Don’t Punish Pain was the driving force behind getting the CVS lawsuit filed in her home state of Rhode Island.

“This lawsuit was born out of the Don’t Punish Pain organization,” she claimed in a Facebook video feed, not mentioning that the lawsuit was filed in Rhode Island because CVS corporate headquarters is located there.

To date, nearly $12,000 has been donated to the GoFundMe campaign, with most of the money coming from hundreds of small donors, many of them pain patients.

Feldman says he and Merandi have had discussions with several lawyers, but so far no one has been willing to take the case against Kolodny.

“I had nothing to do with this litigation. Nothing. Neither does Claudia. Other than the fact that we said we’re happy this has happened. That’s the extent of it.”

— Dr. Arnold Feldman

“No, we haven’t found a lawyer yet,” he said. “But we’re going to find somebody. We’re talking about billions of dollars in litigation.”

“We want to raise a lot of money to pay these lawyers. Lawyers need to get paid and that’s why this GoFundMe is important,” Merandi said while promoting the fundraiser in a recent radio interview. “We need an investigation done and that costs money.”

Until a law firm is found, Feldman says the donated funds will remain untouched in a bank account. “I haven’t taken a dime. Nor will I ever. When we have enough money and find a law firm, that’s where the money will go,” he said.

Asked what would happen if no lawyer take the case, Feldman said the donated funds would be returned to donors. 

“It’ll be a pain in the ass, but of course. I’m not going to buy a BMW with it, I’ll tell you that much. I’m honest as the day is long. I would starve before I took that money,” Feldman said.