Feds Warn of Scammers Impersonating DEA Agents

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

Scammers ‘Well Informed’ of DEA Tactics

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

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

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

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

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

Forced Opioid Tapering Is Risky and Unethical

By Roger Chriss, PNN Columnist

Prescription opioid use has come way down from its peak in 2012. Fewer people receive an initial opioid prescription, pill counts have been lowered, and more people are being taken off opioids.  The American Medical Association recently reported that there was a 37% decrease in opioid prescribing from 2014 to 2019.

The goal of this was to reduce the harms associated with opioid pain medication amid an ongoing drug overdose crisis. But there is no justification for forced opioid tapers. As PNN reported last year, outcomes for patients taken off opioids are not necessarily good. And despite an ongoing focus on reducing prescription opioid use, there is still no established deprescribing strategy or method.

A new study looked at a dozen randomized controlled trials for deprescribing opioids for chronic non-cancer pain. Researchers found that reducing or discontinuing treatment did not reduce opioid use in the intermediate term. It also didn’t increase the number of patients who stopped taking opioids.

After looking at the evidence, the authors of the systematic review concluded that the were unable to draw “firm conclusions to recommend any one opioid-analgesic-deprescribing strategy in patients with chronic pain."

Ethically Unjustified

But even if we knew how to taper patients on prescription opioids, it would still not be ethical to do so. Forced tapers offer relatively few benefits for the patient and may carry serious harms. Policies promoting opioid tapering have nonetheless proliferated in recent years, including one in Oregon that was tabled after a public outcry.

In a recent paper in The Journal of Law, Medicine & Ethics, physicians Stefan Kertesz, Ajay Manhapra, and Adam Gordon argued against the forced tapering policies being promoted by public agencies.

“Neither the 2016 Guideline issued by the Centers for Disease Control and Prevention nor clinical evidence can justify or promote such policies as safe or effective,” they said.

Specifically, Kertesz and his colleagues said “the provider is trained never to treat a patient as merely a means to an end.” In other words, involuntary tapers with the goal of satisfying prescribing metrics or state-mandated statistics are unethical.

A more detailed analysis of the ethics of deprescribing is taken up by Travis Rieder, PhD, author of the book, “In Pain: A Bioethicist’s Personal Struggle with Opioids.” In a new commentary in the AMA Journal of Ethics, Rieder concludes that nonconsensual tapering is “clinically and ethically wrong” because it exposes so-called legacy patients who are dependent on opioids to uncontrolled pain and withdrawal.

“Forcibly tapering otherwise stable patients off high-dose, chronic opioid therapy reveals that this practice might have an effect that is the opposite of what public health is calling for: it may be a harm expanding intervention, exposing those who have long received opioid medications variously to worsened pain, withdrawal, social instability amidst untreated dependence, or loss of medical care relationships,” Rieder said.

“Taking such risks into account, continuing to prescribe high-dose opioid therapy for a legacy patient does not clearly constitute ethical or legal misprescribing.”

‘Large-Scale Social and Medical Experiment’

There is little doubt that prescription opioids involve serious risks and lead to harm for some patients. In some urgent cases, a forced taper may be justifiable in light of specific risks to an individual. But in general, forced tapers not only introduce new risks and create new harms, but they also damage the doctor-patient relationship and deny the patient’s status as an individual.

Stanford pain psychologist Beth Darnall, PhD, calls forced tapering a “large-scale social and medical experiment” being conducted without sufficient evidence on how to do it the right way.

“You may have a patient that has been on a stable dose of opioids for 10 years, and then you start de-prescribing. We are now exposing them to new risks for opioid overdose, for suicidality, for actual suicide, for withdrawal symptoms, for increased pain,” Darnall told The Guardian.

It's worth noting that both Darnall and Rieder were recently named to a new CDC panel that will advise the agency as it prepares to update its 2016 opioid prescribing guideline.

Physicians already have a wide variety of tools to reduce risk and improve outcomes without resorting to the ethically unjustifiable approach of forced tapers. It’s time to emphasize those tools and underscore the ethical importance of patient outcomes.

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. 

UK Guideline Warns Against Using Opioids and Most Other Drugs for Chronic Pain

By Pat Anson, PNN Editor

The United Kingdom may be on the verge of adopting even more stringent opioid guidelines than the United States and Canada.  

The UK’s National Institute for Health and Care Excellence (NICE) has released a sweeping guideline drafted by an expert committee that recommends opioid medication not be prescribed for chronic primary pain at any dose due to lack of evidence and risk of addiction.

“Based on their experience, the committee agreed that even short-term use of opioids could be harmful for a chronic condition. The lack of evidence for effectiveness of opioids, along with evidence of long-term harm, persuaded the committee to recommend against opioid use for people with chronic primary pain,” the guideline states.

The NICE guideline doesn’t stop there. It recommends against the use of virtually every other medication commonly used to treat chronic pain, including gabapentinoids, benzodiazepines, acetaminophen (paracetamol), non-steroidal anti-inflammatory drugs (NSAIDS), ketamine, corticosteroids, and antipsychotics. According to NICE, these non-opioid pain relievers may be addictive, have risky side effects and do more harm than good.

“The committee agreed that not commenting on these medicines could result in their continued use in practice, which would be inappropriate given the lack of evidence and possible harms, so they recommended against the use of these treatments,” the guideline says.

The guideline is the first by NICE to address “chronic primary pain” — a vague term used to describe pain conditions that last longer than 3 months, and cause significant emotional distress and disability, such as fibromyalgia, Complex Regional Pain Syndrome, chronic musculoskeletal pain and symptoms that “can’t be accounted for by another diagnosis.”

NICE said the new guideline “should be used alongside” existing recommendations it has already issued for headache, low back pain and sciatica, rheumatoid arthritis, osteoarthritis, spondyloarthritis, endometriosis and irritable bowel syndrome.

The draft guideline recommends that people with chronic primary pain get physical therapy, acupuncture, psychological therapy and regular exercise. Several other alternative therapies, including transcutaneous electrical nerve stimulation (TENS) and manual therapies such as chiropractic care, are not recommended due to lack of evidence.

Surprisingly, the only class of medication that was recommended for chronic primary pain is anti-depressants such as duloxetine (Cymbalta) and fluoxetine (Prozac), even though their use would be off-label.

Most Treatments Don’t Work

In short, the NICE guideline states that few treatments work for chronic primary pain and most should be avoided.

“There is no medical intervention, pharmacological or non-pharmacological, that is helpful for more than a minority of people with chronic pain, and benefits of treatments are modest in terms of effect size and duration. Additional morbidity resulting from treatment for chronic pain is not unusual, so it is important to evaluate the treatments we offer for chronic pain, to focus resources appropriately and to minimise harm,” the guideline warns.

The draft guidance is open for public comment until September 14.

The head of a large association of UK primary care physicians said the NICE recommendations are welcome, as long as the alternative therapies are made widely available.

“Most patients in pain do not want to take medication long-term, and GPs do not want this either, but sometimes medication has been the only thing that brings relief. As such these new guidelines, which focus on alternative therapies, have the potential to be beneficial for patients - but they will need to be guaranteed appropriate access to them,” Professor Martin Marshall, Chair of the Royal College of General Practitioners said in a statement.

“We should also be mindful not to disregard some medications completely as a lack of evidence may be due to a lack of high-quality research, particularly for older drugs, such as paracetamol.”

NICE estimates that chronic pain may affect between one-third and one-half of the UK population. Almost half of people with chronic pain have a diagnosis of depression and two-thirds are unable to work because of it.

The guideline emphasizes that physicians communicate and work collaboratively with patients to understand the symptoms and causes of their pain.  

“Understandably, people with chronic pain expect a clear diagnosis and effective treatment. But its complexity and the fact GPs and specialists alike find chronic pain very challenging to manage, means this is often not possible. This mismatch between patient expectations and treatment outcomes can affect the relationship between healthcare professionals and patients, a possible consequence of which is the prescribing of ineffective but harmful drugs,” Nick Kosky, a psychiatrist and chair of the NICE guideline committee said in a statement.

“This guideline, by fostering a clearer understanding of the evidence for the effectiveness of chronic pain treatments, will help to improve the confidence of healthcare professionals in their conversations with patients. In doing so it will help them better manage both their own and their patient’s expectations.” 

What If You Can’t Wear a Face Mask?

By Carol Levy, PNN Columnist

Of all the possible repercussions of trigeminal neuralgia -- all the things it keeps me from doing because of the pain -- I never thought it could make me a possible danger to others.

But suddenly I am. Because I cannot wear a face mask.

Because of trigeminal neuralgia (TN), I cannot tolerate any touch to the affected side of my face. The weight of a mask not only causes that side of my face to swell, as though I had been punched, it causes severe pain.

I assumed that everyone with TN has the same issue, probably not the swelling, but definitely the increased pain. I went to our local online TN support group expecting posts such as, “I am worried. I can't mask. What should I do?”

But there was only one post with a link to an article entitled, “What to Do If You Can't Wear a Face Mask.” I was excited expecting answers, but it was not about what to do if you can't wear a mask — more about ways that you could wear an alternative facial covering like a bandana. Nothing about medical or psychological issues that make wearing one difficult.

The article concluded with a list of 3 groups the CDC says should not wear a mask: Toddlers and babies under the age of 2, people with a health condition that causes trouble breathing, and those who can’t remove a face mask without help.

Omitted completely was any mention of medical issues like mine or those who cannot tolerate the touch of a mask against their skin. Don’t fit it into any of the 3 groups? The advice from an emergency room nurse was to stay at home as much as possible, rely on delivery services or loved ones to get essential items, and only go out when you won’t encounter other people. 

That’s good advice. But I, like many seniors and the disabled, have no one to do my shopping or other errands for me. I don’t have the funds to go the delivery route and I can’t go out at night, because my cataracts make night driving dangerous.

So I go out during the day. I made a t-shirt which reads, front and back, “Can’t mask due to medical issue. Trigeminal neuralgia.” Thankfully, people have been very nice to me, with one person even saying, “I am so sorry you need to wear that shirt.”

Recently, I went to a farmers market. A woman looked at me and got visibly excited. Instead of a tongue lashing, she said, “You have that? So does my husband.”

We had a nice conversation, but for all our similarities, he was able to mask. Which takes me back to my first point.

How often have we lamented that no one understands? That our families, friends and colleagues don’t accept why we so often have to say ‘no’ to extra work, a day at the park or other invitations?

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Because of the masking issue, I learned maybe we too don’t always understand. I have seen people in support groups question someone else's report of their pain, how it feels, where it is located, and how they experience it. I never quite understood how anyone could question someone else's pain report.

Now I get it. Our diagnoses may be the same, but our pain experience may be very different. Mine may well not be the same as yours in how it feels, how I experience it or how it manifests itself in my body.

This was a new and important lesson for me. About the only time I can say, “Thank you, coronavirus.”

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.

Genetic Studies Could Pave the Way to New Pain Treatments

By Dr. Lynn Webster, PNN Columnist

Millions of Americans order DNA test kits to determine their ancestries. Knowing where you come from can be entertaining.  However, DNA testing can also help identify your risk of developing some diseases, including chronic pain.

Prenatal testing for genetic disorders is common. But genetic testing is also increasingly used to determine the risk of developing certain diseases or potential responses to specific drugs.

Currently, little is known about how to use genes to make an individual more or less sensitive to pain, or to learn the likelihood that someone will respond in a particular way to an analgesic based on their genetics. The good news is that we are on the cusp of gaining more information about the genes that control pain and pain treatments, and that knowledge should allow us to develop targeted pain therapies.

Most physicians still believe that everyone experiences pain in the same way. Research recently published in Current Biology discovered a gene—the so-called "Neanderthal gene"—that is associated with increased sensitivity to pain. Recognizing that a mutation of a specific gene can influence pain perception may be illuminating for many members of the medical profession.

The Individuality of Pain

Pain specialists have known for a long time that given the same stimulus, some people feel more pain than others. The truth is, there are several genes besides the Neanderthal gene that determine how an individual experiences pain. Some genes increase our sensitivity to pain, while other genes decrease it. Some genes influence how pain is processed, while other genes determine an individual's response to an analgesic.

The ability for an analgesic to provide pain relief in an individual is partially determined by the genetics of the receptor to which the pain medication binds. These genes are different from pain-sensitivity genes. For example, oxycodone may be very effective in relieving pain for one individual, but only partially effective for another.

Optimal pain relief requires recognition that each individual responds uniquely to a given analgesic. Doctors are beginning to provide gene therapy for cancer patients. Advancements in research may someday allow us to do the same for patients with pain.

The array of pain responses to the same stimulus is a major reason why one-size-fits-all dosing of pain medications is flawed. A given dose may leave some patients undertreated and others over-treated. Unfortunately, regulators who set arbitrary dose limits fail to understand or consider this biologic variability. 

Differing clinical responses to pain stimuli and medications underscore the need to individualize therapy. Knowing more about the biology of pain can help us to understand each individual’s response to painful stimuli and the variable response to any therapy.

The Heredity Nature of Pain

How we experience pain is a result of both environmental and genetic features. The genetic factors are what we inherit. Environmental factors — which we develop rather than inherit — include cultural attitudes, emotions, and individual responses to stress. Our personality and life’s experiences are included in the environmental factors that contribute to our experience of pain. Therefore, pain is a result of genetic and environmental interactions. Both can make an individual more or less sensitive to stimuli or analgesia. It is a complex and dynamic process.

The so-called Neanderthal gene is not a new discovery but was newly recognized in Neanderthals. The discovery is interesting, because it implies the gene has an evolutionary purpose. The gene is known as SCN9. There are several pain syndromes associated with the genetic mutations of the SCN9 gene, including some types of back pain and sciatica. Mutations of this gene can result in the total absence of pain or a heightened pain expression. The type of mutation determines the phenotype (or personal characteristics) of our response to a painful stimulus.

The Genetics of Analgesia

It is unclear how Neanderthals benefited biologically from increased pain sensitivity. As we know, acute pain elicits an alarm and is considered protective. It teaches us to avoid dangers that can threaten our life, and prevents us from walking on a broken leg until it heals sufficiently to bear our weight.

Evolution may not have been concerned about the effects of chronic pain. The Neanderthals' limited life expectancy, and the fact that their survival depended on strong physical conditioning, may have made chronic pain a non-issue. Chronic pain may have made survival difficult, or even impossible, for the Neanderthals.

The recent discovery that Neanderthals had the SCN9 gene should not be surprising, given the fact that modern humans shared a common ancestor with Neanderthals. The Neanderthal gene study is of particular interest to me, because I am working with several companies that are exploring potential drugs to affect the function of the SCN9 gene. The companies have different approaches, but they all are trying to find a way to dial down an individual's sensitivity to painful stimuli.

Since the SCN9 gene can be responsible for the total absence of all pain, as well as several extreme forms of pain, it may be reasonable to target the SCN9 gene to modulate pain.

My hope is that manipulation of the SCN9 gene will reduce pain sensitivity, making it easier to control pain by adjusting the dose and type of drug we prescribe.

It is possible one or more drugs that target the SCN9 gene will be available within the next 4-6 years. If that occurs, it could be game changer for people in pain. We can then thank our Neanderthal ancestors for the evolutionary gift. 

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.” You can find Lynn on Twitter: @LynnRWebsterMD

Avoiding Medical Care During Pandemic Could Mean Life or Death

By John Glionna, Kaiser Health News

These days, Los Angeles acting teacher Deryn Warren balances her pain with her fear. She’s a bladder cancer patient who broke her wrist in November. She still needs physical therapy for her wrist, and she’s months late for a cancer follow-up.

But Warren won’t go near a hospital, even though she says her wrist hurts every day.

“If I go back to the hospital, I’ll get COVID. Hospitals are full of COVID people,” says Warren, a former film director.

“Doctors say, ‘Come back for therapy,’ and my answer is, ‘No, thank you.’”

Many, many patients like Warren are shunning hospitals and clinics. The coronavirus has so diminished trust in the U.S. medical system that even people with obstructed bowels, chest pain and stroke symptoms are ignoring danger signs and staying out of the emergency room, with potentially mortal consequences.

A study by the Centers for Disease Control and Prevention found that emergency room visits nationwide fell 42% in April, from a mean of 2.1 million a week to 1.2 million, compared with the same period in 2019.

A Harris poll on behalf of the American Heart Association found roughly 1 in 4 adults experiencing a heart attack or stroke would rather stay at home than risk getting infected with the coronavirus at the hospital. These concerns are higher in Black (33%) and Hispanic (41%) populations, said Dr. Mitchell Elkind, president of the American Heart Association and a professor of neurology and epidemiology at Columbia University.

Perhaps even more worrisome is the drastic falloff of routine screening, especially in regions hit hard by the virus. Models created by the medical research company IQVIA predict delayed diagnoses of an estimated 36,000 breast cancers and 19,000 colorectal cancers due to COVID-19’s scrambling of medical care.

At Hoag Memorial Hospital Presbyterian in Newport Beach, California, mammograms have dropped as much as 90% during the pandemic. “When you see only 10% of possible patients, you’re not going to spot that woman with early-stage breast cancer who needs a follow-up biopsy,” said Dr. Burton Eisenberg, executive medical director of the Hoag Family Cancer Institute.

Before the epidemic, Eisenberg saw five melanoma patients a week. He hasn’t seen any in the past month. “There’s going to be a lag time before we see the results of all this missed care,” he said. “In two or three years, we’re going to see a spike in breast cancer in Orange County, and we’ll know why,” he said.

Dr. Farzad Mostashari, former national coordinator for health information technology at the U.S. Department of Health and Human Services, agreed. “There will be consequences for deferring chronic disease management,” he said.

“Patients with untreated high blood pressure, heart and lung and kidney diseases are all likely to experience a slow deterioration. Missed mammograms, people keeping up with blood pressure control — there’s no question this will all cause problems.”

In addition to fear? Changes in the health care system have prevented some from getting needed care.

Many medical offices have remained closed during the pandemic, delaying timely patient testing and treatment. Other sick patients lost their company-sponsored health insurance during virus-related job layoffs and are reluctant to seek care, according to a study by the Urban Institute.

A study by the American Cancer Society’s Cancer Action Network found that 79% of cancer patients in treatment had experienced delays in care, including 17% who saw delays in chemotherapy or radiation therapy.

“Many screening facilities were shuttered, while people were afraid to go to the ones that were open for fear of contracting COVID,” said Dr. William Cance, chief medical and scientific officer for the American Cancer Society.

Falling Through the Cracks

And then there are patients who have fallen through the cracks because of the medical system’s fixation on COVID-19.

Dimitri Timm, a 43-year-old loan officer from Watsonville, California, began feeling stomach pain in mid-June. He called his doctor, who suspected the coronavirus and directed Timm to an urgent care facility that handled suspected COVID patients.

But that office was closed for the day. When he was finally examined the following afternoon, Timm learned his appendix had burst. “If my burst appendix had become septic, I could have died,” he said.

The degree to which non-COVID patients are falling through the cracks may vary by region. Doctors in Northern California, whose hospitals haven’t yet seen an overwhelming surge of COVID-19 cases, have continued to see other patients, said Dr. Robert Harrington, chairman of the Stanford University Department of Medicine and outgoing president of the American Heart Association. Non-COVID issues were more likely to have been missed in, say, New York during the April wave, he said.

The American College of Cardiology and American Heart Association have launched campaigns to get patients to seek urgent care and continue routine appointments.

The impact of delayed care might be felt this winter if a renewed crush of COVID-19 cases collides with flu season, overwhelming the system in what CDC Director Robert Redfield has predicted will be “one of the most difficult times that we’ve experienced in American public health.”

The health care system’s ability to handle it all is “going to be tested,” said Anthony Wright, executive director of Health Access California, an advocacy group.

‘Sabbatical from Bad Habits’

But some patients who stay at home may actually be avoiding doctors because they don’t need care. Yale University cardiologist and researcher Dr. Harlan Krumholz believes the pandemic could be reducing stress for some heart patients, thus reducing heart attacks and strokes.

“After the nation shut down, the air was cleaner, the roads were less trafficked. And so, paradoxically, people say they were experiencing less stress in the pandemic, not more,” said Krumholz, who wrote an April op-ed in The New York Times headlined “Where Have All the Heart Attacks Gone?” “While sheltering in place, they were eating healthier, changing lifestyles and bad behaviors,” he said.

At least some medical experts agree.

“The shutdown may have provided a sabbatical for our bad habits,” said Dr. Jeremy Faust, a physician in the division of health policy and public health at Boston’s Brigham and Women’s Hospital. “We’re making so many changes to our lives, and that includes heart patients. If you go to a restaurant three times a week or more, do you realize how much butter you’re eating?”

While some patients may be benefiting from a COVID-19 change of regimen, many people have urgent and undeniable medical needs. And some are pressing through their fear of the virus to seek care, after balancing the risks and benefits.

In March, when the virus took hold, Kate Stuhr-Mack was undergoing a clinical trial at Hoag for her stage 4 ovarian cancer, which had recurred after a nine-month relapse.

Members of her online support group considered staying away from the facility, afraid of contracting the virus. But Stuhr-Mack, 69, a child psychologist, had no choice: To stay in the trial, she had to keep her regular outpatient chemotherapy appointments.

“We all make choices, so you have to be philosophical,” she said. “And I thought it was far more risky not to get my cancer treatment than face the off-chance I’d contract COVID on some elevator.”

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Misleading Data and Bias in Canadian Opioid Reporting

By Marvin Ross, Guest Columnist

It is sometimes said that there are lies, damned lies and statistics. That prophetic statement, often mistakenly attributed to British Prime Minister Benjamin Disraeli, explains the complete confusion in the minds of the public about the use of opioid medication.

By conflating data on prescribed opioids with illicit opioids – an apples to oranges comparison -- the average person has no real understanding of the value of opioid pain relievers. How often do we hear people say they refuse to take pain medication for fear of becoming addicted?

One Canadian agency that confuses, conflates and even admits that its data is misleading is the Canadian Centre on Substance Use and Addiction (CCSA). The reports they publish suggest that prescribed opioids are a major problem to be avoided. They are out of step with some of the provincial coroners and federal agencies such at the Public Health Agency of Canada and Health Canada.

Let's first look at what these other agencies report.

Last month, British Columbia reported its highest number of illicit drug deaths ever, nearly 6 deaths per day, with the vast majority involving fentanyl and its analogues. In neighboring Alberta, 127 of the 142 deaths in the first quarter of 2020 involved fentanyl. Neither province talks about deaths from prescribed opioids, as the main issue is illicit drugs.

While fentanyl is a prescribed drug and has many legitimate uses, only 5% of all opioids prescribed in Canada is fentanyl. Given its frequency in overdoses, it must come from illegal sources.

The Public Health Agency divides their overdose statistics into those involving patients with prescribed opioids and those with substance abuse problems.  Prescribed opioids accounted for 0.02% of total hospitalizations, while for the substance abuse population it was 0.04% of hospitalizations.

There are distinct differences in age between the two groups. People in the prescribed group were usually men and women aged 60 and older. For those with substance abuse problems, the most prevalent age group is 20 to 39 years of age. It is well known that illicit drug use is more prevalent in younger people, as this data demonstrates.

Health Canada tracks reported adverse drug reactions for prescriptions and finds that analgesics are the least likely drugs to result in an adverse event. Only 1.8% of all adverse reactions involve pain medications.

Confusing Illicit Opioids with Legitimate Opioids

These statistics all demonstrate that the problem is illicit drug use and not valid prescribed opioids given to patients in pain. In contrast, the CCSA conflates legitimate and illicit opioids, and provides a totally biased picture of what is happening.

Their July 20 report is entitled “Prescription Opiods” with no mention of illicit opioids. But then they provide data that really pertains to the illicit kind.

In 2017, 11.8% of Canadians were prescribed opioids, down from 13% in 2015. Little changed was the proportion of patients who used their prescriptions for non medical uses, which is 3 percent. So, 97% of patients prescribed opioids used them properly.

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Despite that, Canada, like the United States, introduced draconian prescribing guidelines to control the 3% and, of course, that negatively impacted the 97%.

There were nearly 16,000 overdose deaths in Canada between 2016 and 2019, according to the CCSA report, with emergency room visits for opioid poisoning doubling for the 25-44 age group. Given this is a report about prescription opioids, the impression the naive reader would get is that deaths and hospital visits all pertain to legally prescribed opioids.

Next, the CCSA points out that, while the number of opioid prescriptions in Canada has fallen, 5.5% of those taking them can still become addicted. That estimate for addiction is low, but there is other research suggesting that it is even lower. In keeping with their anti-opioid bias, they state that prescription “opioids can also produce a feeling of well-being, relaxation or euphoria (“high”).”

What people who take opioids for pain experience is a decrease in pain or no pain at all, if they are lucky. That's it – there’s usually no high and no euphoria. Addicts take these drugs for its high.

They then move on to talk about the healthcare costs associated with the use of opioids, but again do not differentiate between prescribed and illicit. This leaves the reader with the impression that anyone who takes opioids for any reason is costing the health system extra for adverse events, hospitalizations, overdoses and deaths.

In fact, they are mostly talking about illicit uses as the data they provide is not dissimilar to the data provided by the Public Health Agency or Health Canada. To hammer home the CCSA’s deception, the very next section deals with driving under the influence of prescription drugs.

In 2018, two prominent health experts completed a review of all the independent health agencies funded by Health Canada and recommended that three of them had outlived their usefulness. One of those was the Canadian Centre on Substance Use and Addiction, which they recommended be abolished. For some reason, it still exists.

I asked CCSA to explain their misleading statistics and it took them almost three weeks to respond. Research and policy analyst Samantha King, PhD, admitted the data is misleading unless readers take a deep dive into the footnotes.

“We are aware that for some of the data captured in the summary, including hospitalizations due to opioid poisonings and opioid-related deaths, there is no ability to differentiate between legal or illegal sources of opioids that are causing these harms. For this reason, these sections only refer to opioids in general and contain footnotes where appropriate, highlighting the limitations of the data,” King wrote to me in an email.

So, why call the report “Prescription Opioids” when, unlike coroners and other federal agencies in Canada, you cannot differentiate between illicit opioids and legitimate ones? All I can say is that it is fortunate that Canada's handling of the Covid-19 Pandemic is being handled by the Public Health Agency and not CCSA.

Marvin Ross is a medical writer and publisher in Dundas, Ontario. He is a regular contributor to the Huffington Post.

The Wisdom of CRPS: Making My Final Cancer Treatment Decision

By Cynthia Toussaint, PNN Columnist

A year ago when I got my triple-negative breast cancer diagnosis, the second dreadful thought that ran through my head – perhaps worse than the Big C – was that for any chance at survival I had to once again enter the horrific world of western medicine, a system that for decades had brought me only misery when it came to Complex Regional Pain Syndrome (CRPS).

After five months of researching and contemplating what might be my most hopeful and least harmful treatment strategy, I began chemotherapy with a healthy level of trepidation. While chemo torture can only be described as indescribable, I was stunned and pleased to do well out of the gates. In fact, my tumor disappeared during week one.

In all, I miraculously completed 17 chemo infusions while escaping lethal complications, only because my integrative doctor, Dr. Malcolm Taw, kept a check on my oncologist’s over-treatment. Let it be known that when some people die from “complications of cancer,” they’re really dying from doctors taking that lethal risk due to money and/or hubris. A personal example is the week my infusion nurse refused to administer chemo because my blood count was so low she was afraid I’d get an infection and die.

My oncologist’s goal for me was 18 infusions, a ridiculously high number that I began questioning when I hit twelve. My hair was already growing back, while my body was rabidly flushing the drugs out of my system (don’t ask).

I couldn’t find anyone, in person or on the internet, who’d done more than 12 infusions. Scarier, an oncologist who filled in one morning shared with me that at no time in his career had he seen someone order so many.

My guess is that because my oncologist and the massive health system she works for are aggressively working to prove this chemo regimen is a keeper, 18 would seal the deal for their final report.   

CYNTHIA TOUSSAINT

CYNTHIA TOUSSAINT

I reluctantly marched on with this needless torture for one reason. My oncologist fed me a steady diet of fear, western medicine at its best.

To keep me in line, I dealt with verbal assaults like, “Your cancer’s going to grow right back if you take a week off.” Another was the golden oldie, “I don’t like your questions!” And after the last infusion went south, I was speared with, “All of my other patients want to live.”

The reason I didn’t graduate at the top of my chemo class of one was that, while driving home from number 17, my hands and feet felt like they were bursting into flames while fireworks popped. When John got me upstairs to our condo, he took a picture of the beet-red appendages, my expression frighteningly pale.

After being hideously ill for four days, which is typical as side-effects are cumulative, one afternoon I played the piano for a few minutes and out of nowhere my CRPS, mixed with chemo and my new friend, neuropathy, appeared without mercy in my wrists and hands. As of this writing, five weeks later, I’ve had little let up. While my idiot oncologist never took my CRPS seriously, I’m suffering at a level 9-10 pain and laboring to navigate a world built for people with hands.

So much for number 18, which broke my heart. I’m a goal-oriented gal, and desperately wanted closure for trauma release. At infusion centers, people get to know each other, who lives and who doesn’t, and it’s a big deal when a patient completes their chemo course. The nurses do a hip-hip-hurrah, ring a bell and everyone gets to say goodbye and good luck. I gave it my crazy-strong best, but as usual, CRPS made my decision.

And it would make my next.

Despite not getting the last infusion in, I hit a home run. No, a grand slam. Confirmed with follow-up imaging, I’d achieved a clinical “Complete Response” – the best I could do and hope for. Turns out I’m what they call a “super responder.”

Standard of care dictates that with triple-negative cancer, complete response or not, surgery is mandated (lumpectomy and lymph node removal) to confirm all microscopic malignancies are gone.

This knowing had been looming like a dark cloud since my diagnosis. CRPS and surgery don’t make good bedfellows, as the cutting and tissue extracting tends to fire up nerves that can spark a full-blown CRPS flare. My past has taught me my flares can last a month. Or a lifetime.  

Still deeply influenced by my doctor’s fear-mongering, I kept coming back to surgery despite its risks and my gut telling me to go another way. For once in my life, I wished I’d been well enough to do all the goddamn treatments without having to work around my never-ending pain. Bottom line, I wanted my best shot at living.

But live how? After surgery, would I be left with a life worth living?

The pulsating, burning pain in my hands and wrists provided this answer too. My body told me, unequivocally, that surgery would leave me with the mother-of-all pulsating burning pain. Body-wide and never ending. 

Traumatized that I couldn’t make this big decision, my life-partner, John, reminded me that CRPS has made all of my decisions for me. It didn’t allow me to have a child. I still can’t marry John after 40 years. And it eviscerated my career, one I still yearn for every day. I’m angry that my disease boxes me into corners and knee-caps me at every turn.

Even so, I left fear behind and went toward the light. John and I found three studies, including a meta-analysis, that support de-escalating treatment for triple-negative complete responders. While still early and controversial, these studies show that women who choose active surveillance in lieu of surgery post-chemo live just as long and well -- dare I say even better -- than those who go under the knife.

My integrative doctor, and even my surgeon, are strongly backing my decision – as does my pain doctor who wryly commented, “I don’t see any reason to poke the bear.” 

I’m damn certain that the decision I’ve made to forego surgery will be the standard of care in 15 to 20 years – and that I’m the future. I know deep inside that my CRPS, for all of its hell and fury, is pointing me into a smarter, wiser decision than the one fear would have driven me to. 

This “super responder” is in remission, and moving on…              

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.” 

Top of Form

Can the Chronic Pain Community Unite Before It’s Too Late?

By Peter Pischke, Guest Columnist

What’s the quiet thing often left unsaid in the chronic pain community? An inconvenient truth that some patients and advocates would rather ignore?

Ed Coghlan touched on it when he closed his nearly decade-old blog, the National Pain Report, with a warning.

“In covering the chronic pain community, in addition to meeting hundreds of really interesting people, it is also evident how the community’s fractious nature holds it back,” Coghlan wrote. “Rivalries, which from where I sit look rather petty, prevent a unified voice for truly addressing solutions in fixing a broken health care system that simply does not work for the chronically ill.”

The truth is the pain community is too often the source of hate and weaponized toxicity. Not just against anti-opiate crusaders, but against each other. It’s a self-inflicted problem that may be the most significant handicap to putting together a united front to convince society to end opioid prohibition.

How bad is the problem? To find out, I interviewed over a dozen patients and leaders in the pain community. Included in this group are medical and academic professionals, civil rights activists and patient advocates. Most requested anonymity.

All agreed that there is an enormous problem of toxic behavior plaguing the movement, in which certain advocates target each other with vitriol and purity tests. The stories shared with me include death threats, stalking, harassment, theft, heckling at conferences and plagiarism.

This toxicity, unfortunately, doesn't stop with them. Mirroring the broader political culture online and following the examples set by strident advocates, some patients engage in rumor mills, back-biting and social media mobbing.

The backbiting does not go unnoticed. For some lawmakers and healthcare providers, the pain community is a by-word for crazies, especially online.

“They see the inner fighting, they see what's going on,” says pain patient and activist Jonelle Elgaway. “They also see that we're not united in any way. They ask me, ‘I see the cancer community, and none of that happens in it, does it?’”

Unintended Consequences

Sadly, some prominent advocates are willing to use the vilest attacks against their perceived enemies. They are often sent scattershot, aimed not only at anti-opioid organizations like Physicians for Responsible Opioid Prescribing (PROP), but people who lost loved ones to addiction and pain sufferers deemed insufficiently dedicated to the cause.

As one prominent physician told us, the vitriol creates unintended consequences that only reinforce the stigma that "patients are crazed addicts" – which hurts our ability to persuade leaders in government and medicine that pain patients need help.

Many of those we talked with have been victims of this hate firsthand. Some have staked their personal and professional reputations defending patients, sacrificing careers, relationships, finances and even their family’s well-being to fight for patient rights. One person sold their house so they could continue doing advocacy work. Another burned almost all of their professional relationships to stand up for patients.

Often working quietly behind the scenes, in places like Congress and the CDC, they are the community's most effective warriors. The recent gains we’ve seen, such as the American Medical Association finally taking a strong stand against the CDC opioid guideline, would not have happened without them. Yet, for their sacrifice, the community has rewarded them with bile.

The toxicity is so intimidating that few we spoke to were willing to go on the record. Many are more afraid of the pain community than they are of the news media or organizations like PROP.

The problem also affects our ability to get prominent people to support our cause. Elgaway points out that anytime a celebrity opens up about having chronic pain, unless they meet a purity test for opioids, they are attacked. For example, when actress Kristen Chenowith joined in a marketing campaign for Belbuca, she became an instant target on social media

“Everybody on Twitter kind of jumped on her. She’s famous and she could have been somebody that maybe could have helped us. And I understand you don't agree with her supporting this drug, but you can't jump on everybody that's trying to do something,” Elgaway said. “You know people are going to be afraid of us. They’re going to go back and tell people that chronic pain community is crazy.”

This circular firing squad reinforces negative stereotypes about pain patients, and pushes advocates and potential allies away. It also creates deep fractures in the community, making its most effective leaders too afraid or unwilling to collaborate. Too often, advocates are more concerned with marking turf and tearing each other up, instead of engaging with decisive action that might create real change. How can a coalition grow if every newcomer is pushed away?

This kind of behavior is foolhardy. Some advocates act as if they are the dominant force on the cusp of winning. But the reality is that despite millions of patients losing access to effective pain care, most Americans are still unaware of the pain crisis. What they do know is the story of the opioid crisis. And the media, government and many medical institutions are still invested in that narrative. 

Losing Focus

So why are patients and advocates doing this? I spoke to Dr. Terri Lewis to understand why the pain community can be so hostile, especially online. She told us the negativity reminds her of people “going through the stages of grief."

“It’s a group of folks who may not realize it, but they use social media to shout into the well and hear their voice echo back to them,” Lewis said.

Another factor Lewis points out is that there’s a fundamental cultural clash between pain patients and medicine. The world of medicine and research is slow, while patients want immediate solutions. When you watch doctors, researchers and regulators at a medical conference, the slowness of the process can seem like an infuriating betrayal. As a friend told me, “To them this is just academic, but to us this is our lives.” 

It is natural that pain patients feel angry at the world. They're often mistreated, denied medication and ostracized from society.

But just because we can understand why patients act badly doesn’t mean that behavior should be excused. Nor does it undo the substantial damage it does to the cause.

Dr. Forrest Tennant, a well-respected pain specialist who has sacrificed much for his patients, is concerned that some advocates have forgotten what’s most important.  

It’s a group of folks who may not realize it, but they use social media to shout into the well and hear their voice echo back to them.
— Terri Lewis, PhD

“I'd call for people to try to respect the other person's views. Do the Golden Rule: Do unto others what you'd have them do unto you. I know it sounds simplistic or awfully silly. This is a no-brainer to treat other people kindly,” Tennant said. “We are trying to help people with some very serious diseases that are going to end up with short lives, and we've lost focus on who we are trying to help." 

It isn’t easy to admit mistakes. Everyone makes them, including me.  What matters is that we learn from them and try not to let our egos get in the way. Community heroes like Dr. Red Lawhern encourage reflection and repentance.

“Remember, you can be amazed how much can get done if you don't care who takes the credit," says Lawhern. "Begin with an attitude of humility and the sense that it's not about you.”

Barby Ingle of the International Pain Foundation likens the pain community to a jigsaw puzzle. Every piece is different and sometimes its hard to find where they fit, but to complete the puzzle you need every piece.

“If you want to be the biggest help for yourself and other patients, do what you can do to help those you can help and know that there will be some who don’t want help or believe another way is best. It doesn’t make them not part of the pain community,” Ingle says. “Find or create your niche and work to make a difference, fulfil your goals, and be the best you can be. Be good to yourself and be good to others --even if you disagree.”

If the pain community really wants change, every patient and advocate must self-evaluate and adjust their behavior. We must stop aiming our guns at each other and learn to agree to disagree.

At the end of the day, whatever our disagreements, if we can improve pain care and get meds back for patients, nothing else should matter. We must stop being the community that people fear, and become an inclusive community that welcomes people to join our cause.

Peter Pischke is a freelance journalist and host of the Happy Warrior Podcast. Peter is also a disability activist and chronic pain patient living with intractable pain due to chronic pancreatitis.

This column is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Over-the-Counter Pain Relievers Involved in Growing Number of Suicides

By Pat Anson, PNN Editor

One of the reasons opioid prescriptions have been reined in over the last few years is concern that some patients may use the drugs to take their own lives. One study estimates that up to 30% of fatal opioid overdoses are suicides.

But the risk of suicide is greater with over-the-counter (OTC) pain relievers. According to an analysis of nearly 550,000 calls to U.S. poison control centers from 2000 to 2018, the number of suicide calls involving acetaminophen, ibuprofen and other OTC analgesics rose 57 percent.

Children between the ages of 6 and 19 accounted for about half of those calls, and females represented 73% of cases among individuals of all ages.

“Because they are easy to purchase and can help alleviate a variety of symptoms, many families have over-the-counter pain relievers readily available in their homes, often in large quantities,” said Alexandra Funk, PharmD, co-author of the study and director of the Central Ohio Poison Center at Nationwide Children’s Hospital.

“Unfortunately, the easy access to these medications is likely a big part of the reason that they are used in suicide attempts and deaths. The fact that they are being used more often with more serious outcomes is cause for concern.” 

The study, published in Pharmacoepidemiology and Drug Safety, found that nearly half (48%) of the OTC analgesic calls to poison control centers involved acetaminophen alone, followed by ibuprofen (33%), and aspirin (19%). Acetaminophen accounted for nearly two-thirds (65%) of the 1,745 deaths that were reported.

Rates of suicide-related cases involving acetaminophen and ibuprofen increased significantly during the study period, while the rate of aspirin cases decreased. About a third of the calls involved exposure to multiple substances, and those cases were twice as likely to result in hospitalization or death.

“The top three substance categories associated with suicide-related exposures in the US are antidepressants, OTC analgesics, and antipsychotics, and of these, OTC analgesics are the only one readily available without a prescription or other restrictions,” researchers found. “With suicide-related exposures involving OTC analgesics increasing in the US, more effective interventions are clearly needed to reduce injuries and deaths from this cause.”

One way to reduce the risk if suicide is to regulate the sale of OTC pain relievers by requiring single dose packaging – also known as blister packs. Rather than emptying a bottle of pills, each individual tablet would have to be punched out of the package.

“Because suicidal ingestion is often a highly impulsive act, this would deter overdoses by limiting the amount of medication that can be extracted at one time,” said Gary Smith MD, senior author of the study and director of the Center for Injury Research and Policy at Nationwide Children’s Hospital. “In addition, the U.S. should follow the lead of other countries that have successfully reduced suicidal ingestions of these medications by limiting the package size and quantity that can be purchased by an individual at one time.”

According to another recent study of calls to poison control centers, gabapentin (Neurontin) and the muscle relaxer baclofen are also involved in a growing number of suicides and attempted suicides.  

Suicide is the 10th leading cause of death in the U.S. Over 48,000 Americans took their own lives in 2018.

Neanderthal Gene Makes Us More Sensitive to Pain

By Pat Anson, PNN Editor

The popular image of Neanderthals is that they were brutish and primitive hunter-gatherers who scratched out an existence in Eurasia 500,000 years ago. That may be a bit unfair. Anthropologists say Neanderthals were more intelligent than we give them credit for, lived socially in clans, and took care of each other. They also co-existed for tens of thousands of years with modern humans, competing for food and sometimes interbreeding before the Neanderthals were driven to extinction.

Neanderthals may have had the last laugh though, because we’ve inherited a gene from them that makes some of us more sensitive to pain, according to a new study published in the journal Current Biology. The gene affects the ion channel in peripheral nerve cells that send pain signals to the brain.

“The Neandertal variant of the ion channel carries three amino acid differences to the common, ‘modern’ variant,” explains lead author Hugo Zeberg, a researcher at the Max Planck Institute for Evolutionary Anthropology in Germany. “While single amino acid substitutions do not affect the function of the ion channel, the full Neandertal variant carrying three amino acid substitutions leads to heightened pain sensitivity in present-day people.”

Zeberg and his colleagues say about 40% of people in South America and Central America have inherited the Neanderthal gene, along with about 10% of people in East Asia. Using genetic data from a large population study in the UK, they estimate that only about 0.4% of present-day Britons have the full Neanderthal variation of that specific gene.

“The biggest factor for how much pain people report is their age. But carrying the Neandertal variant of the ion channel makes you experience more pain similar to if you were eight years older,” said Zeberg.

The Neanderthal ion channel in peripheral nerves is more easily activated by pain, which may explain why modern-day people who inherited it have a lower pain threshold. Exactly how the gene variation affected Neanderthals back in the day is unknown.

“Whether Neandertals experienced more pain is difficult to say because pain is also modulated both in the spinal cord and in the brain,” said co-author Svante Pääbo. “But this work shows that their threshold for initiating pain impulses was lower than in most present-day humans.”

It’s possible the heightened sensitivity to pain acted as an early warning system for Neanderthals, alerting them to injuries and illnesses that needed attention. Neanderthals lived a hard life. About 80% of Neanderthal remains show signs of major trauma from which they recovered, including attacks by bears, wolves and other large animals.

Neanderthals made extensive use of medicinal plants. The remains of a Neanderthal man in Spain with a painful tooth abscess showed signs that he chewed poplar tree bark, which contains salicylic acid, the active ingredient in aspirin.  

‘First, Do No Harm’ Doesn’t Mean ‘No Rx Opioids’

By Dr. Lynn Webster, PNN Columnist

Many physicians say their ethical duty is to "First, do no harm." This principle is often mentioned in the context of prescribing opioids. Some people even believe that prescribing opioids to treat people in pain violates the Hippocratic Oath, because, they say, a doctor’s first obligation is not to do anything that could make things worse for a patient.

However, that is a flawed oversimplification of the "First, do no harm" directive.

As N.S. Gill writes in Thoughtco, many people believe that “First, do no harm” is a quotation from the Hippocratic Oath. They are mistaken. More importantly, the creed does not say that doctors must never provide a clinical intervention that might trigger some degree of harm. If physicians had to live by such a code of ethics, they would be unable to offer almost any medical treatment, since they all carry some risk of harm.

As the Harvard Health Blog points out, ensuring that you always "do no harm" would mean no one would ever have lifesaving surgery. Doctors wouldn’t be able to order CT scans, MRIs, mammograms, biopsies or other tests that can turn up false positives; draw blood for fear of bruising or provide vaccines that may cause side effects. Even aspirin is a potentially dangerous treatment for some people. To avoid risk altogether, doctors would have to limit themselves to Band-aids and soothing words.

The Double Effect Philosophy 

“First, do no harm” isn’t about standing by helplessly while someone suffers needlessly. It is an ideal that is better explained by the principles embedded in the philosophy of the Double Effect. 

According to the Stanford Encyclopedia of Philosophy, the Double Effect doctrine means that an action is acceptable if harm occurs in the course of trying to make a positive difference. An intent to do good or help must be the underlying motive. However, the intention to do good by itself is insufficient. The possible good from the action must sufficiently outweigh the potential for harm. 

Often, the Double Effect guideline is used to explain why physicians prescribe opioids even knowing they can pose risk to patients. Doctors prescribe opioids -- sometimes at very high doses -- with the intent to relieve pain (which is “to do good”), because there are few other options available or affordable, and the risk of harm is manageable for most patients. 

This trade-off in decision-making is true for all medications and interventions, not just for opioids. Opioids are not evil agents, despite their checkered reputation among some laypeople, physicians and lawmakers. 

Not Using Opioids Can Causer Harm

Most patients nearing the end of their lives, their families and clinicians who treat terminally ill patients place a priority on a peaceful, pain-free death. Opioids are frequently necessary to fulfill that desire, despite their potential to hasten death. 

Providing opioids to ease end-of-life suffering passes the Double Effect test, but it is still controversial. Furthermore, end-of-life-care is only one area for which some experts question the use of opioids. Some people believe that opioids should never be prescribed because of the harm they may cause, regardless of their potential benefits to patients. 

But not using opioids can also cause harm. In an American Journal of Law and Medicine scholarly essay this month, Kate Nicholson and Deborah Hillman argue that there is a special duty to a subgroup of patients who are already receiving opioids: doctors must not harm them with forced tapering.  

There is also harm, Nicholson and Hillman say, in not treating pain in patients. Based on a Human Rights Watch study, they believe that doctors who deny patients the care they need "in an effort to protect their licenses or stay under the radar of law enforcement" may be violating their patients' human rights. 

Nicholson and Hillman point out that "First, do not harm" has a different meaning for policymakers than for physicians. Policymakers have a responsibility to ensure that society isn't harmed by opioids. However, the authors contend that policymakers have an even greater duty to "do no harm" by respecting the doctor/patient relationship when considering the societal impact of opioid prescribing.  

The patient's need for pain medication, they believe, should be prioritized over society's need for protection against the harm that misused or diverted opioids can cause. 

Our Ethical Responsibility to Patients 

As physicians, we are trained to heal. We become healthcare professionals because we want to provide compassionate care to the sick, the frail, and the dying. We swear an oath to use our best judgment to evaluate the risks and potential benefits in all interventions. Intending to do good, even knowing that adverse effects can occur with every intervention, is our ethical responsibility. 

A mischaracterization of the phrase “First, do no harm” must not prevent providers from caring for people, or prevent policymakers from allowing physicians to treat their patients. That treatment must include providing patients with medication that can adequately provide pain relief with acceptable risk.  

The physician's ethos must always be based on what is best for the patient when all factors are considered -- not on arbitrary guidelines that impose a one-size-fits-all philosophy.  

This column has been revised and updated from a version that appeared in the Salt Lake Tribune on December 10, 2017.

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.” You can find Lynn on Twitter: @LynnRWebsterMD

CDC Appoints New Opioid Workgroup for Guideline Update

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has named a diverse group of physicians, academics and patients to an “Opioid Workgroup” that will advise the agency as it works on an update and possible expansion of its controversial opioid prescribing guideline. Several advisors on the 23-member workgroup also advised the agency during the 2015-2016 guideline process.

Notably lacking on the new panel are any members of Physicians for Responsible Opioid Prescribing (PROP), a small but influential group of radical anti-opioid activists who played an outsized role in drafting the original guideline.

Although voluntary and only intended for primary care physicians treating chronic pain, the guideline’s recommended limits on opioid prescribing were quickly adopted as policy by other federal agencies, dozens of states, insurers, pharmacies and doctors of all specialties.  As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses, leading to uncontrolled pain, withdrawal and, in some cases, suicide.

Not until last year did the CDC publicly acknowledge the “misapplication” of the guideline and promise to make changes – although the process is unfolding slowly. An update to the guideline is not expected until late 2021, nearly six years after the initial guideline was released. It is expected to include new recommendations for the treatment of acute, short-term pain.  

‘Opioids Gave Me a Life’

There are two pain patients in the workgroup, who have contrasting experiences with opioid medication.

One is Kate Nicholson, a civil rights lawyer and patient advocate who took opioids for several years while disabled with severe back pain. Nicholson declined to talk with this reporter about her appointment to the workgroup, but shared her personal experience with the medical use of opioids in a 2017 PNN guest column.

“As soon as I took opioids, I improved. I wasn’t foggy or especially euphoric. In fact, the opposite happened, space opened in my mind and I could work again.  I also never developed a tolerance, requiring more medication for the same level of pain relief,” Nicholson wrote. “Opioids did not heal me. Integrative treatment over a long period of time did.  But opioids gave me a life until I could find my way to healing. Importantly, they allowed me to continue to work.”  

In a 2019 op/ed in The Los Angeles Times, Nicholson said the CDC guidelines should be revised because they were being treated  as “one-size-fits-all mandates” that were harmful to patients.

“The agency needs to revise its guidelines to recommend that physicians not abandon pain patients or engage in ‘forced tapering.’ The CDC should also study and address any unintended consequences of its 2016 guidelines, as it promised to do,” she wrote.

The other patient on the panel is Travis Rieder, PhD, Director of the Bioethics Masters Program at Johns Hopkins University. Rieder severely injured his foot in a motorcycle accident in 2015 and became dependent on opioids while recovering from surgery.

Rieder has written a book and several articles on his experience with chronic pain and the difficulty he had getting off opioids. He also became frustrated with the healthcare system and how it often abandons patients to pain, addiction or both.

“I represented one of the medical community’s most distressing dilemmas: a patient in obvious severe pain but begging for medication that is killing tens of thousands of people a year. The fact that different doctors, in different moments, treated me in radically different ways is completely unsurprising. Because no amount of public hand-wringing or blunt policy tools is going to make it clear what to do with patients like me. We’re a problem, and there’s no obvious solution,” Rieder wrote in his book, “In Pain: A Bioethicist’s Personal Struggle with Opioids.”

‘Clear Need’ for More Specific Guidelines

The other 18 members of the workgroup bring a mix of mostly academic and medical experience to the table.

At least five members of the panel advised the CDC during the drafting the 2016 guideline. They include the chair of the workgroup, Christina Porucznik, PhD, a professor of public health at the University of Utah, who chaired the opioid workgroup in 2016. Chinazo Cunningham, MD, Anne Burns, RPh, and Mark Wallace, MD, are also returning members of the workgroup. They are joined by Jeanmarie Perrone, MD, was a peer reviewer for the 2016 guideline.

In 2018, Perrone called for even more prescribing guidelines.

“There is a clear need for further impactful guidelines similar to the CDC guidelines that outline more specific opioid and non-opioid prescribing by diagnosis," said Perrone, a professor of Emergency Medicine and director of Medical Toxicology at Penn Medicine.

A new addition to the workgroup is Beth Darnall, PhD, a pain psychologist at Stanford University, who has drawn some controversy in the pain community for her studies about “catastrophizing” — a clinical term used to describe patients who are anxious, angry or feel helpless about their pain. She recently began an effort to find another term for catastrophizing.

Darnall, who has advocated against forced opioid tapering, expressed concern about the misapplication of the CDC guideline in a 2019 op/ed published by The Hill.

“Health-care organizations and states have cited the CDC guideline as a basis for policies and laws that extend well beyond its intended purpose. The guideline has been wrongly cited to substantiate proposed dose-based opioid prescribing policies that fail to account for the medical circumstances of the individual patient,” wrote Darnall. “We need flexible policies that provide meaningful access to comprehensive pain care and do not myopically focus on opioid dose reduction policies.”

‘Vast Improvement’ Over Previous Workgroup

The fact that we even know who is on the new workgroup is a small step forward in transparency for the CDC, which refused to disclose the names of any of its advisors when a draft version of the opioid guideline was released in 2015.

Only when threatened with a lawsuit and a congressional investigation did the CDC make the names public. They included Dr. Jane Ballantyne, President of PROP, along with PROP board members Dr. Gary Franklin and Dr. David Tauben. PROP founder and Executive Director Dr. Andrew Kolodny and PROP member Dr. David Juurlink also participated in a “Stakeholder Review Group” for the CDC.

“This group is a vast improvement over the 2016 Guideline group. There are several people here who I know, and who I trust to act as strong patient advocates,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management. “All in all, this is a much better panel, and I'm confident it will produce a much better result for people with pain.”

Twillman cited Burns, Darnall, Wallace and Christine Goertz as workgroup members who would “keep patients in the center of the discussion.”

“The only other member I really know is Jeanmarie Perrone, who, while not a member of PROP, certainly could be. She and I have shared presentation opportunities a couple of times before, and she is very much in the anti-opioid crowd,” said Twillman.

“The new Workgroup constitutes a major improvement over the workgroup involved in drafting the 2016 guideline. That group included a number of well-connected people passionately opposed to the use of opioids in management of chronic pain,” said Stephen Nadeau, MD, a professor of Neurology at the University of Florida College of Medicine.

“Although the new Workgroup membership does not include such people, one could well question the inclusion of several people academically invested in pharmacological or non-pharmacological alternatives to opioid treatment, particularly in the complete absence of comparative effectiveness studies of such treatments.  One could also question the inclusion of surgeons, emergency room physicians, and pharmacists, who do not manage chronic pain.”

More Stakeholders Sought

CDC is seeking additional input from pain patients, caretakers and healthcare providers who will serve as “stakeholders” during the guideline development process. The agency is planning to speak with 100 stakeholders by phone or online for 45-60 minutes “to listen to personal perspectives and experience” related to pain care. The CDC has already obtained written comments from nearly 5,400 people, most of them pain patients.

If you’re interested in being a stakeholder, further information can be found here. The CDC is taking applications until August 21.

The CDC has also funded a series of new studies on opioid and non-opioid treatments for chronic pain. The report on opioids was released in April by the Agency for Healthcare Research and Quality. It concluded that opioids were no more effective in treating pain than nonopioid medication, and that long-term use of opioids increases the risk of abuse, addiction and overdose. At least three PROP members served as experts and peer reviewers during the drafting of that report.

FDA Approves Capsaicin Patch as Treatment for Diabetic Neuropathy

By Pat Anson, PNN Editor

Millions of patients with diabetic peripheral neuropathy live with burning or stinging pain in their hands and feet. In what could be called a case of fighting fire with fire, the U.S. Food and Drug Administration has approved the first use of a medicated patch made with capsaicin – the spicy substance that makes chili peppers hot – as a treatment for diabetic neuropathy.

The Qutenza skin patch is made by Grünenthal and contains 8% capsaicin, which acts on pain receptors in the skin by desensitizing and numbing nerve endings.

“Pain associated with diabetic neuropathy is an extremely challenging condition to diagnose, treat and manage effectively, which has a significant quality of life impact for many patients,” said David Simpson, MD, a Professor of Neurology at the Icahn School of Medicine. “In addition, patients are dissatisfied with unresolved pain and the side effects associated with current systemic treatments.”

A 2015 study found that Qutenza worked faster than pregabalin (Lyrica) in treating neuropathic pain, providing relief in 7.5 days, compared to an average of 36 days in patients taking pregabalin. Patients who used Qutenza were also more satisfied with their treatment and had fewer side effects.

That same year the European Commission approved Qutenza as a treatment for diabetic neuropathy, but it took another five years for the FDA to give its approval for the same condition. The patch was initially approved by the FDA in 2009 for treating post-herpetic neuralgia, a complication from shingles.

“Painful diabetic peripheral neuropathy has a significant impact on the day-to-day lives of millions of individuals, and we believe Qutenza can be a much-needed non-opioid treatment option for these patients,” Jan Adams, Grünenthal’s Chief Scientific Officer, said in a statement. “This expanded indication of Qutenza in the U.S. is an exciting milestone in our efforts to make Qutenza available to even more patients in need worldwide.”  

A big catch is that the patch shouldn’t be applied at home and should only be used sparingly. According to its warning label, Qutenza should be applied by a doctor or healthcare professional, who should be wearing a face mask and gloves to protect themselves in a well-ventilated area. Up to four patches can be applied on the feet for up to 30 minutes, a procedure that can be repeated every three months. The most common side effects are redness, itching and irritation of the skin where the patch is applied.

Qutenza has gotten mixed reviews from patients, who warned that capsaicin can cause painful burning sensations.

“Qutenza really does work. I did have very intense burning,” a patient posted in a review on Drugs.com. “The pain can be mind blowing but it does subside and a cool fan helps. Don't let your pets near the area as it will burn them. I have had multiple Qutenza and… it lasts up to 3 months plus. Don't apply yourselves. Use a health professional as it does burn.”

“Although I was informed about this treatment and how your body might react to it, my case spiraled out of hands,” another patient wrote. “The medics had to call a team to manage my situation. The pain was so much that without a shred of doubt words simply can not explain.”

Diabetic neuropathy is a progressive and debilitating complication of diabetes that affects more than 5 million Americans. Patients typically experience numbness, tingling or stabbing sensations in their hands and feet. More severe cases can result in foot ulcers, amputations and other complications.

How Public Health Failed to Stop Coronavirus Pandemic

By Roger Chriss, PNN Columnist

The pandemic is not going well in the United States, except possibly for the coronavirus. The U.S. is seeing record levels of new confirmed cases, and deaths are back up to almost 1,000 daily. Projections based on positivity rates and hospitalization levels suggest a long summer of illness and death, followed by even more in the autumn.

Several websites are using COVID-19 data to compile visual “dashboards” of what’s happening in states and counties around the nation.

Covid Act Now classifies most of the South as having an “active or imminent outbreak,” while the Covid Exit Strategy marks the entire South and much of the West as having “uncontrolled spread.”

Axios summarizes the nation’s response to COVID-19 with the headline “We blew it.”

“America spent the spring building a bridge to August, spending trillions and shutting down major parts of society. The expanse was to be a bent coronavirus curve, and the other side some semblance of normal, where kids would go to school and their parents to work,” wrote co-authors Dan Primack and Nicholas Johnson.

“The bottom line: We blew it, building a pier instead.”

COVID EXit STRATEGY

COVID EXit STRATEGY

The bleak situation is clearly visible in county-level maps of the country. The Harvard Global Health Institute’s Covid dashboard marks almost all of Florida red. Most counties in the South are also red, and only a handful of counties around the nation are green.

The STAT News preparedness dashboard shows that many counties, particularly in the South and West, are completely unprepared to handle a surge of Covid-19 cases.

Despite all this, there is no nationally coordinated response. As Prevent Pandemics notes in a new report, the U.S. has no standards for collecting and reporting local or national data on COVID-19. As a result, the information is “inconsistent, incomplete and inaccessible in most locations.”

“Particularly in the absence of a clear national vision, strategy, leadership, or organization, it is crucial to establish standardized, timely, accurate, interlinked, comparable, and informative dashboards for every state and county in the US. This is required to improving our control of the virus and maximizing our chance to get our children to school in the fall, ourselves back to work, our economy restarted, and to prevent tens of thousands of deaths,” the report concludes.

The Trump administration has handed over management of Covid-19 to states, as if the virus confines itself within state borders or mutates when crossing them. The White House and some governors have even blamed the current surge on increased testing, though this is mathematically impossible, according to STAT News.

Cities and states are also competing against each other for scarce medical resources like N95 masks and drugs like remdesivir, and disagreeing about public health measures like face coverings and quarantining visitors from hard-hit areas.

Waiting for a Vaccine

The pandemic response in the US seems to be to soldier through until a vaccine becomes available. There is rapid progress with vaccine development, including promising results in Phase I trials from Moderna, Oxford-AstraZeneca, and CanSino. Phase III trials are getting underway, meaning that data should be available by year’s end. If all goes extremely well, large-scale deployment of one or more vaccines could be underway by summer, 2021.

But the coronavirus is well underway now. The Covid Tracking Project shows testing, cases and hospitalizations surging upward week after week, with deaths expected to follow.

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The virus is spreading fast enough that the U.S. could reach herd immunity levels before widespread deployment of a vaccine. This means hundreds of millions of Americans exposed. Even if the rate of serious illness is only 5% and of death is 0.5%, that is still millions of people affected.

Johns Hopkins reports the U.S. has the third highest death rate in the world, behind only the United Kingdom and Chile.

The pandemic will keep going until we stop it. As journalist Debora Mackenzie notes in the book, Covid-19: The Pandemic That Never Should Have Happened: “Science didn’t actually fail us. The ability of governments to act on it, together, did.”

The U.S. has indeed failed and will continue to fail until it develops a coherent public health strategy.

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.