Let’s End the Silence About Endometriosis

By Dr. Kristina Brown, Adler University

Endometriosis causes physical, sexual and emotional pain. About 190 million people around the globe have endometriosis, including one in 10 American women, but there has historically been a deafening silence about the disease and the pervasive impact it can have on a person’s life.

While endometriosis is a chronic gynecological illness that can affect anyone with a uterus – women, transgender men and nonbinary individuals – it often goes undiagnosed because its symptoms can be attributed to other physical or psychological concerns. Patients presenting with this pain are often told it is “all in your head.”

However, endometriosis is becoming a more visible illness, thanks in part to celebrities such as Lena Dunham, Chrissy Teigen, Amy Schumer, Whoopi Goldberg and others who have begun sharing their stories publicly.

After going undiagnosed for 23 years, Padma Lakshmi, a popular cookbook author, actress and host of the TV show “Top Chef,” founded EndoFund, previously Endometriosis Foundation of America, in 2009 so that others do not have to go through what she did.

I am a couple and family therapy professor, clinician and researcher. My own endometriosis diagnosis at the age of 19 has inspired my work exploring how this illness affects others beyond the physical symptoms.

To better understand the impact of endometriosis on relationships, I interviewed 10 couples about their experiences of diagnosis, treatment and living with this disease. Through their stories of how endometriosis-related pain can affect every aspect of daily life, including their intimate relationships, I provide some specific recommendations. The quotes I have included in this article are from my doctoral dissertation research.

Basics of Endometriosis

When a person has endometriosis, the endometrial cells that line their uterus “implant” in places outside the uterus, such as the ovaries, fallopian tubes and the lining of the abdomen — called the peritoneum. At the end of each menstrual cycle, the uterus sheds its lining, which exits the body via the cervix and vagina. The “misplanted” endometrial cells also shed, but they have no place to go – resulting in internal bleeding, inflammation and pain.

An endometriosis diagnosis is described in stages related to the visual presence of the disease, from minimal, or Stage 1, to severe, or Stage 4. However, there is no connection between the stage and the experience of pain.

One symptom of endometriosis is intense pain during the menstrual cycle. Another is pain with sex. Because pain with menses or sex can be attributed to “normal” pain, a history of sexual abuse or psychiatric reasons such as a dislike of sex, some people with endometriosis wait an average of seven years for diagnosis, which can be visually confirmed only through a procedure called laparoscopy.

In addition to these and other types of severe pain, endometriosis can also cause infertility, and patients who want to have children must often undergo medical or surgical interventions to conceive.

Impact on School, Work and Sex

Physical pain from endometriosis can be debilitating. Adolescents with endometriosis may struggle to keep up with their classes, friends, homework or extracurricular activities when the pain becomes too severe. They may shift to home-schooling or virtual learning to complete their studies.

The pain can also deeply affect a career trajectory. “I almost lost my job because of time off,” one interviewee told me. “In fact, when I had to get my hysterectomy, I walked in to tell my manager and he goes, ‘Well, I hope you’re not going to tell me that you have to have a hysterectomy and have to be out for six weeks!’ And I just broke down in tears.”

All of my participants shared experiences where doctors dismissed complaints of sexual pain – called dyspareunia – from endometriosis. This can delay diagnosis and treatment.

Sex and intimacy often become nonexistent, while some couples shared that they have come to accept that pain is part of sex. One woman shared with me: “I don’t want to be touched or have my naked body seen because I feel bloated and ugly and I’m in horrible pain!”

Partners can also be affected emotionally. “I just feel horrible,” one told me. “There are times when we are having sex that I actually feel guilty that I know that I am hurting her and I know she is going to be in pain and it makes me unhappy.”

These experiences of pain, of not being believed by doctors and professionals, of negative effects on education and career and of intimacy destroyed create a heavy emotional burden on individuals and relationships.

Breaking the Silence

When I was diagnosed with endometriosis, it changed the course of my life. My partner and I learned to expand our definition of intimacy and to redistribute household responsibilities when I was incapacitated. As the risk of infertility only increases without intervention, we started conversations about having children earlier than anticipated. My diagnosis also led me to focus my professional identity as a medical family therapist to help others deal with endometriosis and chronic illnesses.

Based on this experience, here are some ways to break this silence:

• Learn about endometriosis. It directly helps when one’s support systems are educated.

• Separate the person from the disease. When the pain you are experiencing from endometriosis is debilitating, help those around you who are also affected to understand that it is because of your endometriosis and it is not personal.

• Speak from your own experience, saying, “I …” rather than “You …” When we do this, it decreases the other person’s defenses and opens up the communication, making space for connection.

My research participants shared their own recommendations with me, especially the importance of believing that their pain is real; accept that what they are sharing is their very real experience, and let them know that they are believed.

Bestselling author and social work researcher Brené Brown has said, “Empathy fuels connection, sympathy drives disconnection.” Approaching someone with endometriosis from a position of empathy sends a message that you want to work with them collaboratively.

By practicing these important relationship skills, we can break the silence around endometriosis.

Kristina S. Brown, PhD, is a Marriage and Family Therapist, and Professor and Chair of Couple and Family Therapy at Adler University in Chicago. Dr. Brown is the Editor-in-Chief of the Journal of Feminist Family Therapy and also serves as the Director of Mental Health for Floating Doctors.

This article originally appeared in The Conversation and is republished with permission.

Is Your Doctor a Good Listener?

By Carol Levy, PNN Columnist

Many of us have had doctors that we loved. They not only listened, but actually heard us. They gave us their time, attention, and cared -- not only about us, but doing the best they could for us.

They truly follow the intent of the Hippocratic Oath: primum non nocere, or “first, do no harm.”

Then there are the doctors who don't care, and don't even seem to care that we know they don't care. They are quick with us. They don't listen or hear. They have their theories. The facts that we give them about how the pain feels, where it is, etc. make no difference.

I went to a new neurologist. She was very nice, but ignored my pain from trigeminal neuralgia and my long history of surgeries and medications. She decided my issue was “anxiety,” which I never said I had.

She repeatedly asked, “Is your problem anxiety?” I shook my head “no” to answer the question and to show my frustration with her for asking it.

Nevertheless, at the end of the appointment, she asked, “Do you want me to prescribe something for your anxiety?”

Primum non nocere? No. She didn't do harm, but she sure as heck didn't help.

Dr. Norton, my neuro-ophthalmologist, didn't seem to care either, at first. He gave me short shrift by rudely saying, “Stop being so schizophrenic in how you're telling me about your pain.”

Because I was so afraid and worried, I gave him the details in scattershot form, instead of chronological and neatly. After two appointments, he finally understood my pain was real. Suddenly, he cared! The change in him was almost palpable. His words were supportive. He worked to give me hope.

When I first went to the hospital for a pain flare, I was overwhelmed by it. It was spontaneous and constant.  My only hope was that Dr. Norton could stop it.

“Is this ever going to go away?” I asked, my voice tremulous with pain and worry.

“Let me worry about that,” he said. “That's my job.”

His words were a verbal hug. Primum non nocere. He cared about me and would make sure I suffered no further harm. I felt like I was being helped.

Dr. Norton was the face of the caring doctor, the one who follows the oath, who puts his patient first. And that makes all the difference.

As for the doctor who wanted me to say I had anxiety, I canceled my next appointment with her. She was the second neurologist I had seen.  The first was also entrenched in his theories and didn't care about me or the facts.

I was concerned about consulting with a third doctor, fearful I would be accused of "doctor shopping.” I asked my nurse practitioner, “Do you think seeing another neurologist will be an issue?" She shook her head no.

"You have valid reasons for not wanting to stay with them. You need to find someone who will listen to you and deal with the pain," she told me.

And she was right.  I needed another doctor, a doctor like Dr. Norton, (who moved out of state). I need a doctor who works with me, not against me.  Who truly practices primum non nocere.

And that should be the goal for all of us.

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. 

‘Make Peace with Pain’: How Chronic Pain Patients Can Reduce Suicidal Thoughts

By Pat Anson, PNN Editor

Suicide is an important but difficult subject in the pain community, as many people with poorly controlled pain contemplate ways to end it. In a PNN survey of nearly 6,000 pain patients, nearly half said they considered suicide because their pain was poorly treated.

“Without my opioid medicines I will be completely bedridden in never ending agony,” one patient said. “I fear I will be forced into suicide like so many before me because living in never ending unrelieved pain is not a life worth living.”

“I have been severely tapered to a very inadequate level of pain medication and am in so much pain that I am essentially in bed 24/7. I no longer have a life. It is merely an existence and I completely understand why chronic pain patients commit suicide,” said another.

“I was raised to believe suicide was a sin, but I can't say for sure how I'll feel about suicide in a few years if this pain I'm in continues to worsen,” another patient wrote.

Fortunately, most pain sufferers don’t act on those suicidal thoughts, but some lose hope and sink into despair. According to a 2018 estimate, about a quarter of all opioid overdoses are suicides or suicide attempts.

How can pain sufferers avoid suicide ideation? A recent study published in Pain Medicine suggests that pain acceptance – “making peace with pain” – can help reduce suicide risk.

“We know for a fact that when people are in pain — and a lot of pain in particular — it makes them think about killing themselves because they don’t want to be in pain forever,” says lead author Willie Hale, PhD, Assistant Professor of Psychology at University of Texas at San Antonio. “We know there’s a direct relationship here between these two things: The more pain you have, the more you’re going to have in terms of suicidal cognitions.”

Hale and his colleagues surveyed 207 patients with chronic pain, mostly active-duty military, veterans or family members. Respondents were asked about their pain severity, attitudes about suicide, and whether they thought they were a burden to others.

The study is based on the Interpersonal Theory of Suicide, which holds that suicidal thoughts or ideation often begin when individuals feel rejected by others and believe they are a burden. When combined with a reduced fear of death and a suicide “capability,” those thoughts can turn into suicidal behavior.

Hale says when people learn to accept their pain and make peace with it, feelings of burdensomeness and thoughts of suicide diminish. The pain won’t go away, but acceptance will help people push through the pain and participate in activities that make life enjoyable again. More meaningful activity results in more social connectivity -- helping to reduce feelings of rejection and burdensomeness.

“If you can move people from making no peace with their pain to just being a little bit okay with it, that cuts their suicide risk in half, and if you can get them to a high level of pain acceptance, it gets rid of it altogether,” said Hale. “Even if you can’t actually, functionally do anything to make their pain better, if you can just get them to make peace with it, they’re going to be less likely to kill themselves.”

Of course, pain acceptance will not improve access to opioid medication or prevent someone from being tapered to an ineffective dose. The best way to prevent suicide – not examined in this study – is to give patients appropriate pain relief.

“I attempted suicide as the only means of pain relief left available to me,” a person in pain told us. “Not because I was sad or depressed, but because I simply could not live another 10 minutes with no relief in sight.”

How Do You Treat Long Covid? Patients Surveyed for Answers

By Esther Landhuis, Undark Magazine

In January 2020, Martha Eckey was working at a retail pharmacy in Champaign, Illinois, when she developed a sore throat, hacking cough, and stiff neck. A second bout of illness struck about a month later, leaving the pharmacist with a persistent fever and shortness of breath. Covid tests were unavailable at the time, but she tested positive for influenza.

The biggest challenge was “crushing, debilitating fatigue,” she told Undark. “No amount of sleep left me feeling even remotely refreshed,” she added by email. Three-and-a-half years later, Eckey has still not recovered.

Shortly after her initial illness, Eckey started reading about people with lingering post-Covid symptoms, and although she never knew for certain which virus caused her initial illness, those symptoms seemed strikingly similar to hers.

After connecting with patients navigating these conditions, Eckey wondered if she had developed myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS, a long-lasting illness that can crop up after a viral infection.

She went to see several physicians, but they “told me they were not taught about post-viral illnesses,” she recalled. “It literally wasn’t in their curriculum.” Eckey had not learned about post-viral syndromes in her four-year doctor of pharmacy training, either.

MARTHA ECKEY

Long Covid and ME/CFS are complex illnesses. Up to 2.5 million Americans live with ME/CFS, and more than 65 million people worldwide may have long Covid — though estimates vary and the dozens of symptoms across multiple body systems can make these conditions hard to define and diagnose. In some people, symptoms linger or intensify with time, but in others they occur weeks or months after recovery from the initial infection, which could be mild or undiagnosed.

In a recent analysis of 9,764 adults enrolled in the federally funded initiative RECOVER, long Covid patients fell into four subgroups based on symptoms, many overlapping with ME/CFS and other conditions. By studying biological samples from these participants, researchers hope to identify markers that can inform future trials of potential therapeutics.

Yet for now, despite an influx of research funding, there are no widely accepted treatments approved by the U.S. Food and Drug Administration to ease sufferers’ symptoms. In that void, desperate patients have turned to a range of proposed solutions — from microbiome treatments to vitamin supplements to experimental techniques like “blood washing” — to find relief. In this vast array of possible therapies, some are exorbitant and most are unproven.

Eckey quit her pharmacy job in August 2020 to search for useful patterns amid that chaos. Unlike most national initiatives and large academic research programs, Eckey is employing a bottom-up approach: She polls patients on which interventions they’ve tried and how they fared, in the hope that this crowdsourced knowledge might contain valuable insights for improving long Covid care.

While surveys like Eckey’s come with inherent limitations, some researchers think such grassroots efforts can help inform more rigorous studies.

“Large clinical trials cost millions of dollars, and it’s impossible to test hundreds of different things at once,” said Akiko Iwasaki, whose lab at the Yale School of Medicine studies the immunology of long Covid. “Knowing what has benefited the patients already provides us with insights that can be tested in future trials.”

Medications and Supplements

Late in the summer of 2022, Eckey, known to social media followers and Substack subscribers as LongCovidPharmD, created several surveys using Google Forms and shared them on Twitter (more recently rebranded as X).

One of the surveys listed about two dozen medications — including Paxlovid, statins, and beta blockers— and had respondents tick boxes for the ones they had tried. It asked them to indicate if taking the drug seemed to “moderately improve,” “vastly improve,” worsen, or have little to no effect on long Covid symptoms or quality of life. Other sections asked if they had conditions that commonly occur alongside ME/CFS or long Covid, such as dysautonomia, mast cell activation syndrome, or a history of blood clots.

Eckey also grew curious about supplements — a category that includes probiotics or enzymes, herbs, minerals, vitamins, and other over-the-counter products with suggested uses that are not regulated by the FDA. In social media posts, she noticed that people commenting on supplements would say, “‘Oh, that didn’t work at all for me,’ and then other people say, ‘oh, that cured me,’” she said.

So she created another survey, listing eight types of supplements and asking to what extent they seemed to help with fatigue, cognitive function, and other symptoms. Motivation for that survey also came from Eckey’s own frustration with being unable to get any prescribed treatments, she said: “I thought, ‘Well, I think I just have to figure out how to treat myself.’”

With more than 200 respondents, the surveys gave a sense for which types of supplements seemed most helpful. Additional surveys focused on the most promising supplements — which doses were used and for what frequency and duration, whether patients improved or felt worse, and which symptoms patients noticed seemed to be affected.

Eckey analyzed the results and started posting detailed summaries on X. Then, in late 2022, her work caught the attention of the Open Medicine Foundation, a California-based nonprofit that has raised $40 million to diagnose and treat complex, multi-system diseases including ME/CFS, long Covid, and others that have eluded doctors.

No Approved Treatments

ME/CFS and long Covid have no FDA-approved treatments, and neither has a definitive diagnostic. The situation echoes that of early days of AIDS, which, decades ago, was defined by symptoms rather than measurable changes inside the body, said Wenzhong Xiao, a computational biologist at Harvard Medical School who directs the foundation’s efforts on ME/CFS treatments.

Regulators typically validate medical treatments through a formal application that specifies the substance’s composition and how it’s made. The application also proposes further study in clinical trials, which generally won’t launch without supportive data from smaller pilot studies. When the Open Medicine Foundation came across Eckey’s work, the organization was already trying to decide which potential treatments to test in pilot studies for long Covid, and was making a registry from which to recruit patients. 

Building on her initial surveys with information gleaned from published trials, case studies, patient feedback, and her “own pharmacist intuition,” Eckey created a more comprehensive version, called “TREAT ME,” and tweeted it on Feb. 5, 2023. 

The survey — which, by Eckey’s account, took about 1,000 hours to produce — covered more than 150 medications and supplements. After collecting details about a person’s symptoms, lab tests, and medical history, the survey asked about treatments: whether they appeared to help, which symptoms improved, how long it took to see benefits, how long the benefits lasted, and whether they were outweighed by side effects. If a medication did not seem to help, the survey asked how long it was tried and at which doses.

“No one has done that deep a dive,” said Linda Tannenbaum, the CEO of the Open Medicine Foundation.

By the time the survey closed for analysis in late March, the responses had climbed to nearly 4,000.

Survey Bias

Despite the potential, surveys have unavoidable, inherent biases that can influence how data is collected and results are interpreted, said internist Lucinda Bateman, founder of the nonprofit Bateman Horne Center — a clinical care, research, and educational organization in Salt Lake City, Utah, that focuses on chronic, complex disorders including long Covid. First, there’s selection bias: Who decides to participate and why? There’s sampling bias: Who never hears about it? There’s also non-response bias: People for whom a treatment has little to no obvious effect may be less likely to participate. 

Surveys also hinge on participants’ own accounts, which aren’t typically confirmed with other sourcing. Eckey’s survey, for instance, relied on respondents to indicate whether they had an official or presumed diagnosis of long Covid or ME/CFS.

The approach also can’t typically account for the placebo effects that result from other factors besides a specific treatment or from other ongoing illnesses or treatments, which may skew the results. And beyond the difficulties with diagnosing long Covid, people may “think they got sick during the pandemic, and it’s entirely something else,” said Bateman. The uncertainty in the data is “just what happens when you do surveys,” she added.

Eckey agreed with these caveats, noting that she tried “to limit bias to the extent that I could.” For instance, to ease non-response bias, the survey instructions encouraged participants to rate treatments “even if they had no effect,” she said.

She also prompted participants to specify underlying conditions and treatments, and responses could be filtered accordingly. And Eckey included one supplement that she believed would have little to no impact on symptoms, figuring questions about it “could act as a sort of ‘placebo’ against which other treatments could be compared.” On a similar vein, she asked about several treatments that were hyped at various times and found their reported benefits to be “underwhelming” or not statistically different from related drugs.

The supplement industry is vast and largely unregulated, with many products lacking solid evidence for health benefits. Research to produce that evidence is a complex, costly process that requires FDA input, often participation from the company that produces the supplement, and approval by an independent ethics committee. What’s more, such trials must follow a company’s best guess on the right doses, optimizing the supplement’s benefit while minimizing side effects.

This approach comes with substantial risks for illnesses like long Covid, which cause a range of symptoms that differ from one person to the next, said David Putrino, director of rehabilitation innovation for the Mount Sinai Health System in New York. A single treatment won’t necessary work for all of them, Putrino, who studies and treats long Covid patients, added in an email, and “you feel like you only have ‘one shot.’”

Eckey’s survey, he said in a phone interview, “allows me to actually make data-driven decisions on what seems to be working.”

The approach is already prompting new studies. Some researchers think that certain long Covid symptoms stem from tiny blood clots; more than 60 percent of Eckey’s survey respondents said they felt better after taking supplements containing enzymes that break down fibrin, the main protein that forms the clots.

These results helped Putrino and colleagues choose one of the enzymes, called lumbrokinase, for a long Covid trial planned for early 2024.

“My desire to get better and help others in similar situations is what keeps me going.”

— Martha Eckey

The Open Medicine Foundation team is also using the survey results to inform drug trials. In a more typical trial, the group mines published scientific literature and uses machine learning to predict which medications might help. These analyses would have likely missed lumbrokinase, since it appears in relatively few academic research papers, Xiao said. Based on Eckey’s survey findings, he said, his team is “definitely thinking about doing follow-up studies.”

Beyond her dataset, Xiao added, Eckey is herself is an inspiration: “I can imagine how much effort she put, despite her own symptoms, to make this happen.”

Eckey’s lingering fatigue still keeps her mostly housebound — and, on some days, stuck in bed — but she told Undark via email that her cardiovascular symptoms have improved. On her better days, she said, she plans to volunteer at a free ME/CFS clinic that treats post-Covid patients: “My desire to get better and help others in similar situations is what keeps me going.”

Esther Landhuis (@elandhuis) is a California-based science journalist and a senior contributor to Undark. She covers biomedicine at all stages — lab discoveries, clinical trials, biotech, healthcare and its intersections with law and business. Her stories have also appeared in Scientific American, Nature, Medscape, JAMA, Science News, Quanta and other outlets.

This article was originally published by Undark, a non-profit, editorially independent online magazine covering the complicated and often fractious intersection of science and society. You can read the original article here.

Is It Safe for Doctors to Recommend Medical Cannabis?

By Dr. Joseph Parker

Nearly two-thirds of oncologists and pain management specialists say they are worried about the legal repercussions of recommending medical cannabis to their patients. This is not an unreasonable fear.

According to one survey, 60% of doctors fear professional stigma, and for good reason. I have seen colleagues call the DEA to report that a physician who certified patients for cannabis was selling marijuana from their office.  As absurd as this might seem, once the DEA gets rolling, they can always find an excuse to prosecute a physician treating pain or addiction. 

Cannabis may soon be moved from a Schedule I controlled substance, with no approved medical use, to a less restrictive Schedule III, where it would be regulated like codeine. This might relax some of those physicians, but I’m not sure it will.

There are many politicians and law enforcement officers who simply believe that marijuana is evil. The extreme was former Attorney General Jeff Sessions, who said at one time that marijuana was “only slightly less awful” than heroin. 

Sessions may truly believe this, but the comparison has no basis.  Heroin can cause respiratory depression and death.  Cannabis cannot.  Heroin works on the endorphin receptors in the brain to trigger a dopamine-mediated reward response, which can lead to what I call “true” addiction. 

Cannabis works predominately through the endocannabinoid system, though it can indirectly influence the release of dopamine and other brain areas associated with the reward system. That’s because the endocannabinoid system and CB1 receptors play a regulatory role in the release of various neurotransmitters, including dopamine.

When tetrahydrocannabinol (THC) binds to CB1 receptors, it can affect the release of dopamine and other neurotransmitters, which contributes to the pleasurable and rewarding effects associated with cannabis use.

I am not saying that someone cannot develop a cannabis substance use disorder or dependence. They certainly can, just like you can with caffeine, sugar or gambling, for that matter.  What I’m saying is that cannabis can make people feel good and want more, but it is nowhere near as dangerous as heroin.  It is also not neurotoxic, like methamphetamine, which can cause the death of brain cells with a single use. 

Some studies actually show a neuroprotective effect from cannabis. And, when taken by itself, cannabis cannot cause an overdose death. This is important. 

Every time the U.S. government targets something, they pay an army of statisticians to generate scary-sounding numbers. For example, you will hear claims that a rise in fatal car accidents was “associated” with cannabis. What exactly does that mean?  It means that a large percentage of accidents involve people who use cannabis, which is unsurprising since about 40% of the adult U.S. population has or is using cannabis.

Those same accidents show a much higher correlation with caffeine.  Caffeine use could be “associated” with probably 90% of all car accidents.  But correlation, of course, does not prove causation. 

These arguments present no evidence that cannabis caused the accidents.  However, the news media can get sloppy about scientific accuracy.  A study will say that a certain number of accidents “involved” cannabis, and the media will report that the cannabis “caused” the accident.

CBD vs. THC

For some reason, Sessions was also obsessed with CBD (cannabidiol). CBD is not THC, which is psychoactive and has a significant effect on a user’s mental processes.  CBD is considered non-psychoactive by a majority of experts, including the World Health Organization.

THC has a higher affinity for CB1 receptors, which are primarily found in the brain and central nervous system, and is a partial agonist for both CB1 and CB2 receptors. Activation of CB1 can cause euphoria and relaxation. It also alters sensory perception, impairs short-term memory, induces anxiety and paranoia, and impairs motor coordination.

CBD does not directly activate those receptors or have those effects. It is instead considered a negative allosteric modulator of CB1 receptors. CBD modifies the CB1 receptor response to THC and actually moderates some of the psychoactive effects of THC.  

There is also evidence that CBD can be anxiolytic and antipsychotic, while THC has been linked (not proven) to be associated with schizophrenia and psychosis.  THC can lead to the release of dopamine, which accounts for the euphoria, but at too low a level to be compared with more addictive substances.

CBD has been found in at least one study to be effective in the treatment of heroin addiction, and in another study to increased motivation, possibly giving us something to treat symptoms of schizophrenia.

Does this all mean it is safe to recommend cannabis to your patients?  Not really. While cannabis has been shown in several replicated studies to be helpful in the treatment of chronic pain, right now it is not safe for doctors to prescribe or recommend. 

Even in states where cannabis is legal for medical use and federal courts have upheld the right of physicians to recommend it, I would argue that the DEA takes a different view.

In the recent prosecution of a physician for “overprescribing” opiates, prosecutors claimed at a press conference that they started investigating the doctor after a call from local police regarding an overdose death.  Evidence later showed this was not the case.  The doctor was actually first targeted for agreeing to certify patients for their state’s medical cannabis program. 

You can help educate your patients about cannabis, but send them on to someone who does not prescribe controlled substances. Until physician rights are restored and protected in this country, it’s just not safe to recommend cannabis.

Joseph Parker, MD, is Chief Science Officer and Operations Officer at Advanced Research Concepts, a company developing solutions to the challenges of space travel and space-related medical issues.  In clinical practice, Dr. Parker specialized in emergency medicine and served as Director of Emergency Medicine at two hospitals. Prior to that, he had a distinguished career in the U.S. Marines and Air Force. 

In 2022, a federal jury convicted Dr. Parker on two counts of unlawful opioid prescribing. He has filed an appeal as he awaits sentencing.

Most Employees Want Insurers to Cover Medical Cannabis

By Pat Anson, PNN Editor

A new survey highlights the divide that often exists between patients, doctors and employers when it comes to using medical cannabis.

EO Care Inc. surveyed 1,027 Americans on their views and use of cannabis. All respondents were employed, either full or part-time, and lived in states where cannabis is legal for medical and/or recreational use.

Nearly one in five (18%) said they had used cannabis for health reasons in the past year, primarily for pain, anxiety, and to help them sleep. A large majority --- 88% --- said it helped them reduce their use of prescription drugs, alcohol or both.

Medical cannabis is so popular that 56% of workers said they would be more likely to take a job at a company that has a health plan that covers cannabis. And nearly half (44%) said they would reconsider applying for a job at a company that tested employees for cannabis or prohibited its use outside the workplace.

Nearly two thirds (65%) said they would feel more comfortable using medical cannabis if they were screened and dosed by a physician. And over half (51%) said they would be likely or very likely to use cannabis if it was covered by their insurer.

Previous surveys have found that doctors and patients are often reluctant to discuss cannabis. Many patients fear they’ll be labeled as drug abusers and lose their jobs if they admit using cannabis; while many doctors don’t consider themselves educated enough to recommend cannabis or have doubts about its safety and effectiveness.

“Finding clinical guidance for medicinal cannabis is difficult because most doctors lack the knowledge and retail dispensaries are not equipped to provide medical advice,” Sean Collins, co-founder and CEO of EO Care, said in a news release. “As a result we have tens of millions of Americans using cannabis for health reasons without guidance on specific product recommendations, dosage amounts, possible drug interactions, or consideration of their health history and other potential health risks.”

EO Care provides its members with access to clinicians who, based on a patient’s needs and medical history, develops a personal cannabis plan for them that includes recommendations for specific CBD and THC products and dosages. Members gain access to EO Care through employers who offer the program as a health benefit.

The company is trying to convince employers that offering cannabis care will help attract and retain good workers. Unguided cannabis use can lead to health issues, bad reactions or even abuse, leading to more sick days and loss of productivity.

“We know a large percentage of Americans have used cannabis in the past year, so this is definitely impacting employees and health outcomes,” said Collins. “With the right medicinal cannabis guidance, employers have an opportunity to help their employees, improve health outcomes and be progressive leaders in offering this important benefit that employees will come to expect.”

Currently, most employers and insurers don’t offer cannabis care, but attitudes are changing. A state court in Pennsylvania recently ruled that workers’ compensation plans must cover medical cannabis when an employee uses it to recover from a workplace-related injury. The court ruled that employees in Pennsylvania had “a statutory right” under state law to be reimbursed for medical cannabis.

Childhood Trauma and Neglect Increase Risk of Headache Disorders

By Pat Anson, PNN Editor

People who experience traumatic events during childhood, such as physical abuse, sexual abuse or neglect, are more likely to have headache disorders as adults, according to a large new study. The research adds to a growing body of evidence linking adverse childhood experiences (ACEs) to headaches and migraines in adults.

“Traumatic events in childhood can have serious health implications later in life,” says lead author Catherine Kreatsoulas, PhD, of Harvard T.H. Chan School of Public Health. “Our meta-analysis confirms that childhood traumatic events are important risk factors for headache disorders in adulthood, including migraine, tension headaches, cluster headaches, and chronic or severe headaches. This is a risk factor that we cannot ignore.”

Kreatsoulas and her colleagues reviewed 28 studies that examined the childhood histories of nearly 155,000 people in 19 countries. Their findings are published Neurology, the medical journal of the American Academy of Neurology.

About a third of the participants (31%) reported at least one traumatic childhood event. Of those, 26% were diagnosed with a primary headache disorder, compared to 12% of participants who said they experienced no childhood trauma. People who had four or more traumatic events during childhood were more than twice as likely to have a headache disorder than those who had one ACE.

Researchers also examined different types of childhood trauma. Events categorized as “threat” traumas included physical abuse, sexual abuse, emotional abuse, witnessing or being threatened with violence, and serious family conflicts.

Events categorized as “deprivation” traumas included childhood neglect, economic adversity, divorce or separation, parental death, alcohol or substance abuse, and living in a household where someone has a mental illness, chronic illness, disability or is incarcerated.

Threat traumas were linked to a 46% increase in headache disorders, while deprivation traumas were linked to a 35% increase in headaches. Among threat traumas, physical and sexual abuse were associated with a 60% increased risk for headaches. Among deprivation traumas, neglect was linked to a nearly three-fold increased risk for headache disorders.

“Threat or deprivation traumas are important and independent risk factors for headache disorders in adulthood,” said Kreatsoulas. “Identifying the specific types of childhood experiences may help guide prevention and treatment strategies for one of the leading disabling disorders worldwide. A comprehensive public health plan and clinical intervention strategies are needed to address these underlying traumatic childhood events.”

Due to the stigma and sensitive nature of childhood trauma, researchers say it’s likely the number of ACE cases is under-reported by adults.

 “Despite this, the robustness of these findings cannot be underappreciated as the studies composing this meta-analysis represent diverse global regions and the findings supersede cultural contexts,” they said.

The research does not prove that ACEs cause headaches -- it only shows an association.

Previous studies have also linked childhood trauma to an increased risk of chronic pain conditions such as fibromyalgia and lupus, as well as mood and sleep problems.

Why Living for Others Keeps Me Going

By Mia Maysack, PNN Columnist

While I am “the strong one” that so many look up to and confide in about their hardships and struggles, there aren't many people that I can reach out to in hopes of receiving the same sort of consideration, counsel or support.

I once expressed to a certified professional that one of the main reasons I'm still in existence is for the sake of other people. They looked at me – perplexed -- and proceeded to explain how that was an “unhealthy” approach to life. My reaction was to smirk, because there was obviously no way in hell this individual could begin relating to, let alone understand, what I was saying.

The vast majority of my experiences with therapy have been that the provider and I may as well have been speaking different languages.

Repeatedly, I'm confronted by individuals who say things such as:

“It's my kids who keep me going!”

“I do it all for them! They are my reason for living! I didn't know love or the point of life until I had children!”

I honor all of that to the best of my ability, but also wonder. What’s the difference between that mindset and the point that I made with the therapist?  There isn't one -- other than the fact my motivation doesn't come from having children, but rather from the brokenness of our world as a whole.

What do I mean when I say I live for the sake of others?  It's that I'm equipped with such a deep sense of compassionate empathy that I am able to hold the edges for people who ordinarily do not feel heard or seen. This somehow cultivates the illusion that I'm superhuman, and don’t need to be seen or heard myself.

Just because some of us don't outwardly complain or vent doesn't mean we have it all together, that everything is easy, or that we ourselves aren't drowning in a sea of despair.

Most people wouldn't know how to handle it, if I shared with them the reality of what my life is truly like. They wouldn't know how to respond if I told them that just getting out of bed for me is like running a marathon. Or if I described the pain and torment in my physical body, which keeps me away from things that I want to do and bring me a sense of meaning, joy and purpose.

They certainly don't know how to handle it when the person they depend on reveals that they're beginning to crumble under the weight life has forced them to carry. Anytime that I've attempted to confide in someone, there are three things that occur:

1. They aren't listening to actually hear you, but are simply awaiting their turn to speak -- which usually involves some sort of comparison between your situations, with a hinted suggestion that their situation is far worse than yours.

2. You make them uncomfortable by expressing yourself authentically. They don't know what to do or say, which often translates into doing or saying not much of anything.

3. It causes them major concern and worry, to the point that I then have to reassure the people I sought comfort from that I’m okay.

It has become easier to remain silent. That is why we suffer. That is what’s killing us.

I have zero questions in my mind as to why someone makes the decision to die. That doesn’t mean condoning or promoting it. I simply comprehend the endless reasons why life can be so tiring and how a lifetime of exhaustion can get old -- to the point where someone no longer wishes to go onward.

I believe in everyone's ability to choose and proceed with what's best or right for them, whether I agree or understand it. I've lost countless loved ones and that has been sufficient reason for me not to check out. I can't do it because so-and-so did. I want to carry on so they continue to live through me.

Although I still feel that way most of the time, it needs to be understood how draining it is. Those of us who've managed to cling to an optimistic viewpoint aren't free from our own demons. We slay them daily for the sake of showing up for you and yours.

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. She is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill. 

Study Finds Low Risk of Overdose From Prescription Opioids

By Pat Anson, PNN Editor

A large new study that identifies the top risk factors for an overdose involving prescription opioids has inadvertently shown just how low the risk is in the first place.

In a systematic review published in the Canadian Medical Association Journal, researchers at McMaster University looked at 28 studies involving nearly 24 million patients in the United States, Canada and the United Kingdom who were prescribed opioids for chronic pain.

They found 10 “predictors” associated with a higher risk of a fatal or nonfatal overdose, such as a patient taking high doses, having a substance abuse problem, and having multiple prescribers or pharmacies.

Many of these risk predictors are already well-known. What’s different about this study is that the researchers calculated the odds of an overdose happening in different situations and doses. That’s where things get interesting:

“High-certainty evidence from 14 studies involving 1,315,173 patients showed a linear dose–response relationship with opioid overdose. The association was small at a 50-mg morphine equivalent dose/day (OR 1.69, 95% CI 1.50–1.90) and large at 90 mg (OR 2.57, 95% CI 2.08–3.18), with an absolute risk 2.6 per 1000 for fatal overdose and 5.1 per 1000 for nonfatal overdose at a 90-mg morphine equivalent dose/day.”

In plain English, the risk of a fatal overdose at 90 morphine milligram equivalents (MME) is not “large.” It’s only 0.26% at 90 MME, which is considered a fairly high dose. The risk of a fatal overdose is even lower at 50 MME – just 0.16% -- a level that researchers say is “small-to-trivial.”

I’m not a statistician, but 0.26% and 0.16% seem like pretty small odds – similar to the lifetime risk of dying in a car accident, fire or drowning. Unlike opioids, there is no talk of a ban on swimming pools, motor vehicles or matches.

“I think that most people living with chronic pain would agree with your interpretation,” says co-author Jason Busse, DC, a clinical epidemiologist and professor of anesthesia at McMaster University. “I do think, however, that a minority of patients will place greater value on the possibility of overdose and death even though the absolute risk is small.”

Busse’s involvement in the study is notable, because he was the lead investigator in Canada’s 2017 opioid guideline, which suggest that initial doses of opioids be kept under 50 MME and strongly recommend that they never exceed 90 MME. The CDC opioid guideline in the United States makes similar recommendations.

Given the small risk of an overdose actually happening at 50 or 90 MME, the new study would seem to debunk both guidelines. Busse sees it a bit differently, telling me by email that the overdose calculations will help patients understand the risks associated with prescription opioids.

“Our work in this area has suggested that most people living with chronic pain, who have not found sufficient relief with non-opioid therapy, would be interested in a trial of opioids. Specifically, when provided with the evidence for benefits and harms, including the risk of overdose, that most patients in whom non-opioid therapy has proven insufficient would elect to pursue a trial of opioid therapy,” Busse said.

“By presenting the evidence to patients, and helping them to understand the anticipated benefits and harms, we can help ensure that the decisions they make are the right ones for themselves.”

Unfortunately, pain patients in the U.S. and Canada don’t get to make decisions for themselves. Decisions are made for them by doctors, pharmacists, regulators, and law enforcement. Patients increasingly have trouble finding a provider willing to treat them or getting a prescription filled at a pharmacy.

And because the “voluntary” opioid guidelines are usually treated as mandatory,  patients who are prescribed opioids are often kept at ineffective low doses that are well below 90 or even 50 MME.

‘Opiods Kill and Opioids Are Bad’

Experts say the low risk of overdose from prescription opioids was established in previous studies, but people got caught up in opioid hysteria and ignored the evidence. The new study, they say, is no different.

“This paper examines well plowed ground and provides no new insight. Quite the contrary, it obfuscates through oversimplification of the problem,” says Stephen Nadeau, MD, a Professor of Neurology at the University of Florida College of Medicine. “The essential message is that opioids kill and opioids are bad.”

Nadeau says Busse and his co-authors ignored factors like genetic differences in opioid metabolism and put too much emphasis on the risk of a patient having multiple prescribers or pharmacies. The latter could simply be a sign that they were abandoned by a doctor or turned away by a pharmacy, not doctor shopping. Statistics mined from databases don’t tell you that.

“This paper takes a rigorous statistical approach to explain what is happening in a highly heterogeneous population in which there is a high probability of misconstruing the sources of variance. I think it would have been OK if published in 2015, but we have learned a thing or two since then and now the paper serves only to obfuscate and mislead,” said Nadeau.

Two findings in the study worth highlighting are that researchers found little risk of an overdose when a patient is co-prescribed opioids with benzodiazepines, sedatives or muscle relaxants – the so-called “Holy Trinity.” The overdose risk is also “small-to-trivial” when a patient is given long-acting opioids instead of short-acting ones. Those findings contradict the recommendations made in the U.S. and Canadian guidelines.

“The opioid crisis has generated interest in identifying patients at higher risk of addiction or overdose and has led to the development of several screening tools; however, these instruments have either not been validated or shown poor psychometric properties,” wrote lead author Li Wang, PhD, a researcher at McMaster University. “Our findings suggest that awareness of, and attention to, several patient and prescription characteristics, may help reduce the risk of opioid overdose among people living with chronic pain.”

One of the co-authors of the study is David Juurlink, MD, a member of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Like several other PROP members, Juurlink disclosed that he has been a paid expert witness in legal cases involving opioids.

Previous studies have also found that the risk of overdose is small — 0.3% — in Medicaid and Medicare patients prescribed opioids for the first time. Another study of Medicare patients found that over 90% had little to no risk of overdosing. Low risk patients had only 0.006% chance of an overdose.

Experimental Fiber Implants Block Nerve Pain with Light

By Pat Anson, PNN Editor

Researchers at the Massachusetts Institute of Technology have developed experimental fiber implants that could potentially be used to deliver pulses of light from inside the body to inhibit nerve pain. Unlike other implants, the hydrogel fibers are flexible and stretch with the body during movement.     

“Current devices used to study nerve disorders are made of stiff materials that constrain movement, so that we can’t really study spinal cord injury and recovery if pain is involved,” said co-author Siyuan Rao, PhD, now an assistant professor of biomedical engineering at the University of Massachusetts at Amherst. “Our fibers can adapt to natural motion and do their work while not limiting the motion of the subject. That can give us more precise information.”

In tests on laboratory mice with genetically modified nerves, researchers used the fiber implants to deliver blue light to the sciatic nerve, which activated the animals’ hind limb muscles.

When pulses of yellow light were used, the light inhibited neuropathic pain in the mice.

For now, MIT engineers see the fibers primarily as a research tool that can help them study the causes and potential treatments of peripheral nerve disorders in animals.

Credit: Sabrina Urbina Villafranca

Neuropathic pain occurs when peripheral nerves are damaged, resulting in tingling, numbness and stinging sensations in the hands and feet. About 20 million Americans suffer from peripheral neuropathy, which can be caused by diabetes, chemotherapy, lupus, HIV, Lyme disease, celiac disease and many other disorders.

“Now, people have a tool to study the diseases related to the peripheral nervous system, in very dynamic, natural, and unconstrained conditions,” said co-author Xinyue Liu, PhD, who is now an assistant professor at Michigan State University. 

The MIT team’s study, recently published in the journal Nature Methods, grew out of a desire to expand the use of optogenetics -- a technique in which nerves are genetically engineered to respond to light. Exposure to specific light waves can either activate or inhibit a nerve, giving scientists a new way to study how nerves work. 

Scientists have used optogenetics in animals to trace nerves involved in a range of brain disorders, including addiction, Parkinson’s disease, and mood and sleep disorders.

Until now, optogenetics has primarily been used in the brain, an organ that lacks pain receptors, which allows for the relatively painless implantation of rigid devices. The MIT team wondered if optogenetics could be expanded to nerves outside the brain to study peripheral nerve pain.  

Because peripheral nerves undergo constant pushing and pulling from adjoining muscles and tissues, they needed more flexible devices that would not constrain movement or cause tissue damage.  

The new optical fibers are made with hydrogel — a rubbery mix of polymers and water – that is soft and flexible. The fiber has two layers; a core and an outer shell that funnel light through the fiber without escaping or scattering. 

When implanted in mice, researchers say the animals were still able to run freely on an exercise wheel. After two months, the fiber was still resistant to fatigue and could transmit light efficiently to trigger muscle contractions. 

“We are focusing on the fiber as a new neuroscience technology,” Liu says. “We hope to help dissect mechanisms underlying pain in the peripheral nervous system. With time, our technology may help identify novel mechanistic therapies for chronic pain and other debilitating conditions such as nerve degeneration or injury.”

We Must Overcome Stigma Against Buprenorphine for Pain

By Dr. Stefan Franzen

For years I had a negative impression of buprenorphine as a pain medication, both from personal descriptions I had heard by pain patients and from the scientific and medical literature.

I have since learned that buprenorphine can be effective pain reliever. At a high dose, the efficacy is similar to that of high-dose morphine or oxycodone, which were once commonly used to treat chronic or intractable pain.

Today, high doses of any opioid are shunned by most doctors because they are subject to increased scrutiny by state medical boards or even investigation by the Drug Enforcement Administration. The medical and moral justification of alleviating patient suffering appears to be irrelevant to public health authorities, even when they profess to favor a humane policy to treat pain.  

We need a more rational discussion about opioids. Buprenorphine is an opioid that, when used alone, can play a role in pain treatment. Buprenorphine was developed in the United Kingdom in the 1960s and has been used in many countries to treat pain since the 1980s.

We must distinguish pure buprenorphine from Suboxone, which is a combination of buprenorphine and naloxone. Suboxone is given to people with opioid use disorder to help prevent abuse. If a tablet is crushed, extracted or injected by a drug abuser, the naloxone will block the effects of buprenorphine. However, if taken as directed under the tongue, the naloxone has much lower bioavailability.

A pain patient does not necessarily need naloxone and, depending on individual differences in body chemistry, the naloxone may even have negative effects. There is no reason to prescribe Suboxone for pain. It’s use as a pain medication is highly inappropriate, but may be the result of doctor’s fear of DEA action.

Pure buprenorphine is a different matter.

The CDC’s 2016 opioid guideline recommended that daily opioid doses not exceed 90 morphine milligram equivalents (MME).  Although voluntary, the guideline was seized upon by other federal agencies and state legislatures to justify draconian new laws and regulations that limited opioid doses to 90 MME or less.

No such limits have been set for buprenorphine. However, few doctors in the U.S. prescribe buprenorphine for pain, despite recent studies demonstrating its efficacy and international recognition that it is an effective analgesic.

For historical reasons, American doctors do not know much about buprenorphine as a pain medication. Moreover, many fear prescribing any opioid in today’s regulatory climate. Patients know that buprenorphine has been used to treat addiction and therefore are suspicious of it as a pain treatment. They are also justifiably concerned about being stigmatized as a drug abuser if they are prescribed Suboxone.

U.S. Opioid Policy Lacks Common Sense

In short, the stigma surrounding buprenorphine is a significant factor preventing development of a rational opioid policy in the U.S.

Many patients with experience taking morphine, oxycodone, hydrocodone and other opioids say they are safe and non-addictive. Research shows that is true for a great many pain patients. However, a small fraction of the population is susceptible to opioid abuse and addiction. This is a classic ethics problem.

Should we let 99% of patients suffer because 1% might harm themselves? How do other societies manage this problem? We know what doesn’t work. The “War on Drugs” has been an unmitigated disaster for everyone: drug abusers, doctors, pain patients and their loved ones. Our drug overdose rate is 15 times higher than that the of European Union.

Worse still, our medical system and corporate regulation appear to lack common sense guardrails needed to prevent the diversion of prescription opioids -- even after massive publicity, sensational books, documentaries, and popular miniseries on the opioid crisis.

In case anyone had any doubt, the book “American Cartel” shows that diversion was mainly practiced by large opioid distributors and a few manufacturers, who flooded vulnerable communities with prescription opioids. Theft and deception of doctors by drug abusers also contributed to diversion. Each of these could be controlled in a sensible way, without forbidding people in pain from receiving medication. Yet, at present it appears there is no political will in the U.S. to even treat pain, regardless of the suffering of millions.

Instead, the politicians and media blame opioid prescribing, which implicitly blames doctors and patients. Perhaps as a response to this seemingly hopeless situation, a growing number of medical researchers have begun testing pure buprenorphine for the treatment of pain.

After seeing the effectiveness of buprenorphine, which I discuss in my new book, “Z’s Odyssey,” I became convinced that it is a viable treatment for even severe, intractable pain. This should be a choice, but the problem today is that many patients do not have a choice.

Pure buprenorphine for pain was not available in the United States until 2010, when the low-dose Butrans skin patch became available.

In 2015, a buccal formulation designed for absorption through the cheek became available. Belbuca film is quite convenient and comes in a moderate dose.

For intractable pain, a sublingual formulation of buprenorphine known as Subutex can be prescribed off label for pain. Subutex is also used to treat opioid addiction, but does not contain naloxone.

A Subutex tablet placed under the tongue takes about 20 minutes to be completely absorbed. Because buprenorphine binds to the pain receptors more tightly than any other opioid, the dose in milligrams required for full effect is much lower than similar strength morphine. Many medical researchers have concluded that buprenorphine is an excellent analgesic, with low risk for addiction or overdose. If taken as directed, the risk of respiratory depression from buprenorphine is the lowest of any opioid.

For pain relief, U.S. doctors must prescribe Subutex off-label, which means that they are prescribing for a condition that is not FDA approved.  Subutex is approved for pain in Great Britain and most of Europe. The UK’s National Health Service recommends Subutex and other formulations of buprenorphine for patients “when weaker opioids for pain stop working.”

Of course, buprenorphine is not beneficial for every patient. And there is an issue of dental decay that requires careful monitoring and appropriate procedures. But for people in the most severe pain, who lack any other option because of the opioid prohibition mindset, buprenorphine may offer relief.

Finding a doctor willing to prescribe Subutex off label could be difficult. For severe or intractable pain that requires a high dose, a patient most likely needs to find a psychiatric or addiction treatment doctor licensed to prescribe buprenorphine in formulations such as Subutex that are pure buprenorphine.

Since 2000, the U.S. Congress has passed three laws that make buprenorphine more accessible to people with opioid use disorder.  If Congress can aggressively lower the barriers to prescribing high-dose buprenorphine for addiction treatment, then why shouldn’t pain patients have access to medication that has the same dose of the active agent?

There is an education gap that prevents doctors and society at large from effectively managing this situation. The medical literature is heavily weighted toward studies of buprenorphine for addiction, with almost 97% of studies on opioid use disorder and less than 3% on pain.  Pain patients also fear the stigma associated with buprenorphine as an addiction treatment, rather than an analgesic.

There is no objective reason for this. At the very least, buprenorphine should be an option for those forgotten patients who still live in pain. By overcoming the stigma of buprenorphine, doctors could treat patients with dignity by prescribing a safer and more effective medication. 

Stefan Franzen, PhD, is a Professor of Chemistry at North Carolina State University. Franzen is the author of “Patient Z” – a book that looks at pain, addiction and the opioid crisis through the eyes of a patient who can’t find good pain care. He recently published a sequel to Z’s story, called “Z’s Odyssey.”

Did Covid Vaccine Mandates Do More Harm Than Good?

By Dr. Rachel Gur-Arie, Arizona State University

Ending pandemics is a social decision, not scientific. Governments and organizations rely on social, cultural and political considerations to decide when to officially declare the end of a pandemic. Ideally, leaders try to minimize the social, economic and public health burden of removing emergency restrictions while maximizing potential benefits.

Vaccine policy is a particularly complicated part of pandemic decision-making, involving a variety of other complex and often contradicting interests and considerations. Although COVID-19 vaccines have saved millions of lives in the U.S., vaccine policymaking throughout the pandemic was often reactive and politicized.

A late November 2022 Kaiser Family Foundation poll found that one-third of U.S. parents believed they should be able to decide not to vaccinate their children at all. The World Health Organization and the United Nations Children’s Fund reported that between 2019 and 2021, global childhood vaccination experienced its largest drop in the past 30 years.

The Biden administration formally removed federal COVID-19 vaccination requirements for federal employees and international travelers in May 2023. Soon after, the U.S. government officially ended the COVID-19 public health emergency. But COVID-19’s burden on health systems continues globally.

I am a public health ethicist who has spent most of my academic career thinking about the ethics of vaccine policies. For as long as they’ve been around, vaccines have been a classic case study in public health and bioethics. Vaccines highlight the tensions between personal autonomy and public good, and they show how the decision of an individual can have populationwide consequences.

COVID-19 is here to stay. Reflecting on the ethical considerations surrounding the rise – and unfolding fall – of COVID-19 vaccine mandates can help society better prepare for future disease outbreaks and pandemics.

Types of Vaccine Mandates

Vaccine mandates are the most restrictive form of vaccine policy in terms of personal autonomy. Vaccine policies can be conceptualized as a spectrum, ranging from least restrictive, such as passive recommendations like informational advertisements, to most restrictive, such as a vaccine mandate that fines those who refuse to comply.

Each sort of vaccine policy also has different forms. Some recommendations offer incentives, perhaps in the form of a monetary benefit, while others are only a verbal recommendation. Some vaccine mandates are mandatory in name only, with no practical consequences, while others may trigger termination of employment upon noncompliance.

COVID-19 vaccine mandates took many forms throughout the pandemic, including but not limited to employer mandates, school mandates and vaccination certificates – often referred to as vaccine passports or immunity passports – required for travel and participation in public life.

Because of ethical considerations, vaccine mandates are typically not the first option policymakers use to maximize vaccine uptake. Vaccine mandates are paternalistic by nature because they limit freedom of choice and bodily autonomy. Additionally, because some people may see vaccine mandates as invasive, they could potentially create challenges in maintaining and garnering trust in public health. This is why mandates are usually the last resort.

However, vaccine mandates can be justified from a public health perspective on multiple grounds. They’re a powerful and effective public health intervention.

Mandates can provide lasting protection against infectious diseases in various communities, including schools and health care settings. They can provide a public good by ensuring widespread vaccination to reduce the chance of outbreaks and disease transmission overall. Subsequently, an increase in community vaccine uptake due to mandates can protect immunocompromised and vulnerable people who are at higher risk of infection.

Early in the pandemic, arguments in favor of mandating COVID-19 vaccines for adults rested primarily on evidence that COVID-19 vaccination prevented disease transmission. In 2020 and 2021, COVID-19 vaccines seemed to have a strong effect on reducing transmission, therefore justifying vaccine mandates.

COVID-19 also posed a disproportionate threat to vulnerable people, including the immunocompromised, older adults, people with chronic conditions and poorer communities. As a result, these groups would have significantly benefited from a reduction in COVID-19 outbreaks and hospitalization.

Many researchers found personal liberty and religious objections insufficient to prevent mandating COVID-19 vaccines. Additionally, decision-makers in favor of mandates appealed to the COVID-19 vaccine’s ability to reduce disease severity and therefore hospitalization rates, alleviating the pressure on overwhelmed health care facilities.

However, the emergence of even more transmissible variants of the virus dramatically changed the decision-making landscape surrounding COVID-19 vaccine mandates.

The public health intention (and ethicality) of original COVID-19 vaccine mandates became less relevant as the scientific community understood that achieving herd immunity against COVID-19 was probably impossible because of uneven vaccine uptake, and breakthrough infections among the vaccinated became more common. Many countries like England and various states in the U.S. started to roll back COVID-19 vaccine mandates.

With the rollback and removal of vaccine mandates, decision-makers are still left with important policy questions: Should vaccine mandates be dismissed, or is there still sufficient ethical and scientific justification to keep them in place?

Vaccines are lifesaving medicines that can help everyone eligible to receive them. But vaccine mandates are context-dependent tools that require considering the time, place and population they are deployed in.

Though COVID-19 vaccine mandates are less of a publicly pressing issue today, many other vaccine mandates, particularly in schools, are currently being challenged. I believe this is a reflection of decreased trust in public health authorities, institutions and researchers – resulting in part from tumultuous decision-making during the COVID-19 pandemic.

Engaging in transparent and honest conversations surrounding vaccine mandates and other health policies can help rebuild and foster trust in public health institutions and interventions.

Rachel Gur-Arie, PhD, is an assistant professor with Edson College of Nursing and Health Innovation at Arizona State University. Her expertise lies at the intersection of ethics, global health and policy. Prior to joining ASU, Rachel was a Hecht-Levi postdoctoral Fellow, focused on ethics and infectious disease, at Johns Hopkins University and the University of Oxford. She completed her doctorate in health systems management and served as a Fulbright Scholar at Ben-Gurion University of the Negev in Israel.

This article originally appeared in The Conversation and is republished with permission.

Sickle Cell Patients Face Life-Threatening ER Waits

By Sara Hutchinson, KFF Health News

Heather Avant always dresses up when she goes to the emergency room.

“I’ve been conditioned to act and behave in a very specific way,” said Avant. “I try to do my hair. I make sure I shower, have nice clothes. Sometimes I put on my University of Michigan shirt.”

HEATHER AVANT

It’s a strategy to combat discrimination the 42-year-old photographer in Mesquite, Texas, has developed over a lifetime of managing her sickle cell disease, a rare blood disorder that affects an estimated 100,000 Americans.

The hereditary condition can affect a person of any race or ethnicity, but Black patients, like Avant, make up the majority of those afflicted in the U.S.

For people living with the disease, a sickle cell crisis can happen at any time. When it does, their rigid, sickle-shaped red blood cells become stuck in their blood vessels, blocking flow and causing extreme pain or breathing difficulties.

A crisis can escalate into life-threatening complications such as strokes, seizures, and sepsis.

When a pain crisis can’t be managed at home, patients head to the ER to get the high dosage of opioids they need, in addition to IVs to help with dehydration or even blood transfusions. Yet staffers in emergency departments — already overextended and grappling with nursing shortages — don’t always have experience in treating the rare disease. And many doctors, amid a still-raging opioid crisis, remain resistant to prescribing the painkillers necessary to treat sickle cell crises.

As a result, patients with sickle cell disease often face long delays before receiving essential ER care, plus discrimination and suspicion that they are seeking drugs to get high.

“I have to look like I’m not coming in here off the street looking for medication,” said Avant. “I have to put on an entire show to get you to believe that I need care.”

Long Waits

Years of research have documented the delays. A study published in 2013 found that patients seeking care from 2003 through 2008 at an ER for their sickle cell crises waited 50% longer than patients who arrived with broken legs or arms.

Another study published in 2021 found that 50% of sickle cell patients reported having to wait at least two hours before their pain was treated, despite medical guidelines recommending such patients in crisis receive their first dose of pain medication no more than 60 minutes after arriving at the ER.

Medical associations such as the American Society of Hematology, the National Heart, Lung, and Blood Institute, and the Emergency Nurses Association have established guidelines for emergency department-based care of sickle cell pain. And, in 2021, the Emergency Department Sickle Cell Care Coalition, a national collaboration of hematologists, pharmacists, and nurses, helped launch a point-of-care tool to help medical professionals manage the disease in the ER.

But patients and sickle cell experts said those best practices haven’t been widely adopted. A 2020 survey of nearly 250 emergency medicine providers found that 75% of them were unaware of the NHLBI’s recommendations, first published in 2014, yet 98% felt confident in their ability to treat patients with sickle cell disease.

Still, ER horror stories abound among adults with sickle cell disease. For Lesly Chavez, 29, a Houston hairstylist, her worst experience occurred a few years ago. She said she spent four hours in a waiting room before getting seen.

“And when they finally got to me, they told me they could help with ‘my addiction,’ but they decided that there was nothing that they could do for me,” Chavez said. “They just flat-out said no and sent me home while I was in crisis.”

Chavez said she has since avoided that hospital even though it’s 10 minutes from her home. Now she drives to an ER 30 minutes away.

Chavez, who is Hispanic, said she confronts “doubt everywhere I go” because sickle cell disease primarily affects Black Americans. (Those who are Hispanic can be of any race.)

Paula Tanabe, a professor of nursing at Duke University who has spent decades researching ways to improve care for sickle cell patients, said a confluence of factors adds to the racial bias patients may face.

“Emergency rooms are incredibly overcrowded, at rates that we have never seen before, and that’s for everyone,” said Tanabe.

‘People Are Going Uncounted’

Legislators are trying to help. A federal bill introduced in June would allocate $8.2 million annually for five years to a program that trains doctors on best practices for caring for sickle cell patients. Another, introduced this spring, would provide funding for community organizations working to spread awareness about the condition and give student loan relief to medical providers who commit to working on the disease. Some state legislatures have established sickle cell task forces to improve physician education and care coordination.

Advocates for sickle cell patients said investment in data collection to track the disease is also important. Although the Centers for Disease Control and Prevention estimates that some 100,000 Americans have it, the true number is unknown. That’s because no national system exists to collect data on sickle cell, unlike other conditions such as diabetes, cancer, and Alzheimer’s.

“I’m 32 and we’ve been saying it’s 100,000 my entire life,” said Quannecia McCruse, who co-founded the Sickle Cell Association of Houston. “I know there’s more. I know people are going uncounted.”

Eleven state-led data collection programs currently exist and, in February, the CDC opened a new grant application for additional states. Improved data would allow funding to be allocated toward the areas with the greatest need, sickle cell patient advocates said.

Texas had an opportunity to join those efforts. This spring, the state legislature passed a bill with broad bipartisan support to create a sickle cell patient registry, but Republican Gov. Greg Abbott vetoed it, saying it would compromise patient privacy.

“That was a bad excuse,” said McCruse. “We have a cancer registry already, and everyone’s information is safe. That registry would have gone a long way to help.”

While progress grinds slowly, patients like McCruse say they’re forced to balance advocating for themselves during bouts of excruciating pain against the need not to irritate or alienate hospital staffers.

“It feels like someone is taking a Taser and shocking the crap out of me. Or when it’s really bad, and it feels like shards of glass are just moving through my veins,” said the mother of two. “It’s very, very painful. And you’re telling somebody whose body is torturing them that it’s not that bad?”

Alexis Thompson, a hematologist who treats sickle cell patients at the Children’s Hospital of Philadelphia, said she works with her pediatric patients to develop self-advocacy skills. But sometimes that backfires.

“The great irony is patients who are well informed and capable of self-advocating are being accused of being manipulative, because they are capable of articulating very clearly what’s effective for them down to the name of the medication or the absolute dose,” Thompson said.

Sickle cell experts recommend that doctors adhere to a patient’s individual pain plan, if available. Thompson said those plans, which document patients’ diagnoses alongside a recommended medication and dosage, can be uploaded to online portals that patients can pull up on their cellphones when visiting an ER to verify what they need.

Patients such as Avant hope such steps can help decrease their ER waits while easing their anxiety about seeking emergency care.

“I don’t fear dying,” said Avant, “but I do fear dying in the hospital.”

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

Drug and Medical Supply Shortages Impacting Patient Safety at ‘Alarming Rate’

By Pat Anson, PNN Editor

Over half of U.S. hospitals are reporting shortages of drugs and supplies used in anesthesia, pain management and emergency care, according to a new survey by a nonprofit healthcare organization. Nearly nine of out of ten (86%) respondents said they were rationing or restricting the use of medications in short supply.

The survey of nearly 200 hospital administrators, pharmacists and supply chain managers was conducted by the Emergency Care Research Institute (ECRI) in July.

“Their responses suggested that providing safe and appropriate drugs, supplies, and equipment has become extremely challenging and led to numerous instances of unsafe practices, compromised care, and potentially harmful errors. Many of the respondents clearly communicated their struggles to address shortages which are occurring at an alarming rate,” the ECRI report said.

Respondents reported shortages of over 20 drugs, single-use supplies, or medical equipment. The shortages primarily affect surgery and anesthetics (74%), emergency care (64%), pain management (52%), cardiology (45%), hematology and oncology (44%), infectious diseases (39%), and obstetrics and gynecology (37%).

“While medication and supply shortages have been widely reported across healthcare, we now know with certainty that these shortages are causing preventable harm and have the potential to cause even more if they are not addressed soon,” Marcus Schabacker, MD, president and CEO of ECRI, said in a statement.

“There are strategies hospitals can use to reduce the impact of shortages, but they are a deviation from standard practice and resource-intensive -- two characteristics that themselves can increase the likelihood of preventable harm.”

Many hospitals (42%) are stretching supplies by using medications after their expiration date, reusing single-use devices, or using drugs for purposes outside of their specific labeling. Nearly a quarter of respondents (24%) said they knew of at least one medical error related to a drug, supply or device shortage.

Specific examples of how shortages have impacted patient care include:

• Interruption or delays in chemotherapy

• Use of more opioid analgesia due to lidocaine shortages

• Incorrect medication instructions given to patients

• Postponement or cancellation of surgeries 

To address shortages of masks, gowns and other personal protective equipment, many hospitals have turned to non-traditional sources that supplied products with “alarmingly poor performance,” according to ECRI.

For example, tests on KN95 masks obtained from nontraditional suppliers found that up to 70% did not filter particulates the way manufacturers claimed. And tests on disposable gowns revealed that over half failed to meet even minimum standards for protection.

“The extent to which medication, supply, and equipment shortages are negatively impacting patient care is inexcusable,” said Rita Jew, PharmD, president of the Institute for Safe Medication Practices, an ECRI affiliate. “While pharmacies and hospitals can triage shortages short-term, we need long-term, nationally coordinated solutions to solve the persistent shortages we’ve witnessed repeatedly over the last several years.”

Supply Interruptions

Many respondents also expressed concern about drug shortages worsening after a Pfizer plant in North Carolina was heavily damaged in July by a tornado. The Rocky Mount plant was a leading supplier of sterile injectable drugs used in surgery, pain management and emergency care. Pfizer recently resumed production at the plant, but doesn’t expect full operations to be restored until later in the year.     

“While manufacturing has resumed, it is important to note that some medicines may not be back in full supply until next year,” the company said in a statement.

The American Society of Health-System Pharmacists (ASHP) recently expanded its shortage list for injectable morphine to include morphine vials made by Pfizer. The company said the vials are on back order and could not estimate a release date. The lack of supply is having a snowball effect on other drug manufacturers, who say they’re running out of injectable morphine and hydromorphone due to increased demand.

The ASHP recommends that providers use “extreme caution” when switching morphine concentrations or interchanging them with other injectable opioids because patients could react to them differently.

Limited supplies of morphine, hydromorphone and other injectable opioids were being reported long before the tornado damaged Pfizer’s plant or the pandemic disrupted the global supply chain. Despite that, the Drug Enforcement Administration has aggressively cut the supply of many opioids, reducing production quotas for hydromorphone by 71% and morphine by 65% from their peaks in 2016.       

GRAPHIC COURTESY OF MONTY GODDARD

The Food and Drug Administration put injectable morphine and hydromorphone on its drug shortage list in 2017, the year after DEA started cutting the opioid supply.  In recent months, the ASHP added oxycodone and hydrocodone tablets to its drug shortage list, but their limited supply has not yet been acknowledged by the FDA.

A recent federal lawsuit accused the DEA of “incompetence” in its handling of the nation’s drug supply, specifically the production quotas the agency sets for amphetamines used in ADHD medication.

Drug makers are required to report shortages and supply interruptions to the FDA. Doctors, pharmacies and consumers can also report them by email to the FDA at drugshortages@fda.hhs.gov. To report a drug shortage to the ASHP, click here.

Woman Files Civil Rights Lawsuit Over Denial of Pain Treatment

By Madora Pennington, PNN Columnist

In September of 2022, millions watched Tara Rule’s emotional video on TikTok, about a doctor who refused to give her a non-narcotic pain medication because it might cause birth defects. The doctor would not even name the drug, even though Rule told him she has no intention of having children because she has Ehler's Danlos syndrome (EDS), a genetic disorder that causes severe health issues.

The 32-year old Rule recently filed a civil rights lawsuit to better establish the illegality of refusing medical treatment to women simply because they are of childbearing age.

Rule’s fight began when neurologist Jonathan Braiman, MD, steered her away from an effective treatment for her agonizing cluster migraines, a common symptom of EDS. According to Yale Medical School, cluster headaches can hurt more than childbirth.

When Rule realized she was being discriminated against by her doctor, she surreptitiously switched on her cell phone to record their discussion, which is legal in New York state. 

Brainman can be heard in the recording asking Rule intrusive questions about her sex life, while ignoring her answers. Rule explained that she was already on a medication that can cause birth defects -- known as teratogenic drug -- and wasn't well enough to have children anyway.

Brainman patronizingly told her she might change her mind if she were to become pregnant. He recommended that she bring in her boyfriend to consent to any treatment that might cause birth defects. Rule left without getting the pain relief she needed for her migraines.

In the parking lot of Albany Medical Center, where the appointment took place, a distraught and tearful Rule made the video and posted it online. Her raw emotion and disturbing story quickly went viral, not only on social media, but in news stories.

In her lawsuit against Braiman and Albany Medical, Rule alleges she was retaliated against by the hospital system. Rule says she was ejected from an unaffiliated urgent care center because Albany Medical had told other hospitals not to treat her. She believes this was a violation of her medical privacy.  

Rule suspects she was blacklisted by other providers in her area. She tried to make an appointment with another neurologist, but was told she was “not an appropriate patient.” Her primary care provider sent a back-dated letter to Rule and her mother saying he was dismissing them as patients. That doctor gave no valid reason for the patient abandonment.

TARA RULE (TIKTOK)

Rule is on disability and lives on less than $1,000 per month. Being banned as a patient is a real hardship.

“Now I have to go to Connecticut to see physicians in a different hospital system. Or travel three and a half hours to New York City. With hotels and gas, it’s very hard. Some of these specialists outside the state are not fully covered by my insurance,” Rule said.

Traveling is made more complicated because Rule can’t stay just anywhere — she needs accessible hotel rooms. And she is accumulating thousands of dollars in debt.

After posting her video, Rule heard from many other patients who have also been discriminated against by their doctors. She felt motivated to find out what legal remedies existed.

With legal guidance, Rule wrote the civil rights complaint herself in what is known as a “federal question” lawsuit, an action that seeks to clarify a constitutional issue in US federal court. Rule has been advised that the medical care she sought does not fall under “conscience protections,” which allow doctors to refuse treatment on religious or moral grounds.  

In preparation for her lawsuit, Rule obtained her medical and insurance records, to help prove that privacy violations occurred. She discovered she had been billed for services not received, and believes her medical records were forged.

Albany Medical did not respond to a request for comment.

Rule’s lawsuit is potentially precedent-setting. It marks the first federal question case against a medical provider for refusing to provide teratogenic drugs because a woman is of “childbearing age.” Refusing to give routine medical care because a patient might get pregnant is discrimination. Patients cannot be forced into unnecessary restraints on their care.

"I am prepared for whatever happens,” says Rule, who is hopeful her lawsuit will help prevent other patients from being discriminated against by their doctors. 

Madora Pennington is the author of the blog LessFlexible.com about her life with Ehlers-Danlos Syndrome. She graduated from UC Berkeley with minors in Journalism and Disability Studies.