How Chronic Pain Affects Relationships

By Victoria Reed, PNN Columnist

People with chronic pain are often engaged in a battle with their own bodies. Unfortunately, sometimes we also struggle to be believed and supported by family members, friends and doctors. While some may be fortunate to have a supportive spouse or significant other, many pain sufferers lose their life partners along the way, as well as friends.

Pain can take a toll on our relationships. In my own experience, a good friend slowly faded into the background during a particularly difficult time when I was having numerous flares from rheumatoid arthritis and fibromyalgia. The flares cause debilitating fatigue and severe pain. I would often need to cancel plans and never could (and still can’t) predict which day I would wake up feeling awful.

Sometimes when I did not cancel plans, I would end up being miserable the entire time and would regret my decision. Eventually, the invitations and phone calls dwindled, as I was probably considered unreliable.

During that time, I would go for weeks struggling to function and keep going for the sake of my family and young children. But life doesn’t stop when you have a chronic illness. Homework still has to get done, as well as housework, financial matters and shuttling the kids to and from school and to sporting events.

One time, as I was driving my daughter home from gymnastics practice, I was so tired that my car ended up nose to nose with another car in a turning lane! I just barely missed having a head-on collision! Fortunately, the woman I almost hit wasn’t angry, but was actually concerned and asked if I was okay. The experience was frightening because I’d put my child in danger by driving when I was so fatigued.

It was then that I realized how serious my fatigue was and worried about the effect it was having on my relationships and family. Unless you actually experience this kind of fatigue, it can be hard to really understand it.

Additionally, my husband (at the time) was having trouble coping with my illnesses. We had been married for 18 years when we decided to divorce. I obviously wasn’t the same person that I was in the beginning and couldn’t contribute an equal share in the relationship.

The truth of the matter is that chronic pain is hard on everyone. It takes its toll not only on those physically suffering, but on spouses and significant others as well. Some make it known that it’s not working, while others quietly build resentment until they can no longer stay in the relationship. Then, seemingly out of nowhere, it’s “I want a divorce” or “I’m leaving” or “I can’t do this anymore.”

Perhaps they are overwhelmed by increased household chores and responsibilities or feel neglected in some way. Or maybe they fall out of love because you are not the person they married or agreed to be with. Perhaps they are stressed because of the additional financial burden resulting from your lack of income. Perhaps they don’t believe in your illness or think that you are faking your symptoms.

I certainly don’t have all the answers, but you must then pick up the pieces, move on and try to create a new life for yourself. If you have kids, you may have guilt about having an illness or believe that you are the cause of your family’s dismantling. 

Having chronic pain is like having a third person in the relationship. That “person” demands constant attention and spends many hours trying to get between the two of you, taking time away from you and your loved one.

However, if you are lucky enough to have that special someone who is capable and willing to deal with your chronic illness and truly understands and accepts, it might not mean the end of your relationship. Many people do stick with and endure the challenges of having an ill partner. It takes a very special person to be able to do that.

It’s good to have a few good friends who are supportive and understanding, rather than a bunch of people who say they are friends, but never step up to the plate. I’ve learned that family members who can’t be supportive have no place in my life. I believe it’s important to surround myself with positive people. Negative people can be emotionally draining and almost always are takers, rather than givers.

Those of us who have been abandoned must move on for our own emotional and physical well-being. As awful as it might seem at the time, it gives us the opportunity to meet new people who are able to give the love, support and compassion that we deserve.

Victoria Reed lives in Cleveland, Ohio. She suffers from endometriosis, fibromyalgia, degenerative disc disease and rheumatoid arthritis.

CBD Reduced Burnout and Depression in Healthcare Workers

By Pat Anson, PNN Editor

After a year and a half of social distancing, masks and isolation, are you feeling emotionally burned out from the pandemic?

If so, you’re not alone. A recent survey of over 1,000 workers found that over half reported they were fatigued, depressed and had trouble concentrating.  Another study in the UK found that healthcare providers and other essential workers were particularly at risk of depression due to the stress of COVID-19.

With that in mind, researchers at the University of São Paulo in Brazil recently conducted a study to see if daily doses of cannabidiol (CBD) could relieve emotional exhaustion and burnout symptoms in a cohort of 120 frontline healthcare professionals.

Half of the study’s participants received 300mgs of CBD oil daily for four weeks. The other half did not receive CBD. All participants were evaluated weekly by a psychiatrist and encouraged to exercise.

The research findings, published in JAMA Psychiatry, found that participants who received CBD treatment had a significant reduction in emotional exhaustion and burnout compared to those who did not. CBD consumption was also associated with less anxiety and depression, but had no impact on post-traumatic stress syndrome (PTSD).

Five participants in the CBD group dropped out of the trial after suffering from serious adverse events, mostly elevated liver enzymes. Those cases resolved after CBD of discontinued.

“This randomized clinical trial found that the efficacy and safety of daily treatment with CBD, 300 mg, for 4 weeks combined with standard care was superior to standard care alone for reducing the symptoms of emotional exhaustion, anxiety, and depression among frontline health care professionals working with patients with COVID-19,” researchers reported.

“Burnout among health care workers is an important issue for health care systems, with a direct impact on quality of care. No pharmacological treatment is currently available for the prevention or treatment of burnout symptoms and emotional exhaustion among frontline health care professionals working with patients with COVID-19… Therefore, the results of the present study could have a relevant impact on the mental health of health care staff worldwide.”

The researchers said more placebo-controlled trials were needed to assess whether CBD could be used more broadly as a mental health treatment.

Previous studies have also found that medical cannabis reduced symptoms of depression. A 2020 study conducted in New Zealand found that people consuming up to 300mg daily in CBD oil reported significant improvement in their pain, mobility, anxiety and depression. Some also said they slept better and their appetite improved.

Another 2020 study found that 95% people who smoked or inhaled cannabis through a vaporizer reported a decline in depression within 2 hours. Cannabis with high levels of tetrahydrocannabinol (THC) was particularly effective in reducing depression.

Experts Debate Need for Covid Booster Shots

By Rachana Pradhan, Kaiser Health News

The Biden administration’s plans to make covid-19 booster shots available next month has drawn a collective scream of protest from the scientific community.

As some scientists see it, the announcement is rash and based on weak evidence, and they worry it could undercut confidence in vaccines with no clear benefit of controlling the pandemic. Meanwhile, more information is needed on potential side effects or adverse effects from a booster shot, they say.

Perhaps even worse, the announcement has fueled deeper confusion about what Americans need to do to protect themselves from covid.

“I think we’ve scared people,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the National Institutes of Health and the Food and Drug Administration.

“We sent a terrible message,” he said. “We just sent a message out there that people who consider themselves fully vaccinated were not fully vaccinated. And that’s the wrong message, because you are protected against serious illness.”

As of Thursday, 51% of the U.S. population was fully vaccinated, Centers for Disease Control and Prevention data shows. Biden administration officials ― citing data from Israel, a study from the Mayo Clinic that is not yet peer-reviewed and new CDC studies ― say it’s necessary to plan for boosters to prevent a worsening of the pandemic as the delta variant powers a surge in cases and overwhelms hospital intensive care units.

In essence, officials are caught between a rock and a hard place ― trying to be prepared while simultaneously not undermining messaging about how well the existing vaccines work.

Virus Unpredictable

Officials must weigh two unknowns: the risks of moving ahead aggressively with booster shots versus the risks of waiting to learn much more about the virus and the power of the vaccines. The government’s normal path to regulatory approval is, by design, slow and deliberate. The virus has its own schedule, fast and unpredictable.

“Arguably, I think that the federal government is simply trying to stay ahead of the curve,” said Dr. Joshua Barocas, associate professor of medicine at the University of Colorado. But, he said, “I have not seen robust data yet to suggest that it is better to boost Americans who have gotten two vaccines than invest resources and time in getting unvaccinated people across the world vaccinated.”

Beginning in late September, boosters would be made available to adults (age 18 and up) eight months after they received the second dose of a Pfizer-BioNTech or Moderna covid vaccine, President Joe Biden said. But his plan comes with big caveats: It does not yet have the blessing of a CDC advisory panel, and the FDA has not authorized boosters for all adults.

The urgent question is whether the vaccines are losing their power against covid.

“We are concerned that this pattern of decline we are seeing will continue in the months ahead, which could lead to reduced protection against severe disease, hospitalization and death,” Surgeon General Vivek Murthy said.

But many scientists and public health experts say the data doesn’t demonstrate a clear benefit to the public in making booster shots widely available, and the Biden administration’s message confuses people about what the covid vaccines were designed to do.

“They’re not a force field. They don’t repel the virus from your body. They train your immune system to respond when you become infected … with the goal of keeping you out of the hospital,” said Jennifer Nuzzo, an epidemiologist and associate professor at the Johns Hopkins Bloomberg School of Public Health.

Meanwhile, questions abound. Will boosters for fully vaccinated adults make the virus less transmissible ― that is, slower or less likely to spread to others?

“I certainly hope that’s the case … but the bottom line, with full transparency, we don’t know that right now,” Dr. Anthony Fauci, Biden’s chief medical adviser, said Wednesday.

What about side effects? “It would be nice to understand what side effects people have after their third dose,” Nuzzo said.

“We don’t have any reason to believe, based on the safety profile of the vaccine itself, that we’re going to see significant adverse events with booster shots,” Barocas said. However, those things are “just now being studied.”

The concerns are real. While serious side effects from covid vaccines have been rare, some have caused alarm ― including mRNA vaccines being linked to cases of myocarditis, or inflammation of the heart.

“At the individual level, we need to know the side effect profile of a 3rd dose, especially in younger people. Until now, the benefits of vaccination have far outweighed the potential side effects,” Dr. Jeremy Faust, an emergency medicine physician at Brigham and Women’s Hospital in Boston, wrote in a blog post outlining why he was skeptical about a plan to give boosters to everyone.

Vaccines Still Effective

Even in light of the new CDC studies published Wednesday, experts say one thing is clear: The vaccines still work very well at what they were meant to do, which is to protect people against the worst outcomes of getting infected with the virus.

One study, relying on data from 21 hospitals in 18 states, found no significant change in the vaccines’ effectiveness against hospitalization between March and July, which coincides with delta becoming the prevalent covid strain. Another, using data from New York, also found the vaccines highly effective in preventing hospitalization, even as there was a decline in effectiveness against new infections. The third, evaluating the Pfizer and Moderna vaccines in nursing home residents, saw a drop in how effective they were at preventing infection ― but the research didn’t distinguish between symptomatic and asymptomatic cases.

“It’s like we’re engaged in friendly fire against these vaccines,” Nuzzo said. “What are we trying to do here? Are we just trying to reduce overall transmission? Because there’s no evidence that this is going to do it.”

Fauci, in outlining the case for boosters, highlighted data showing that antibody levels decline over time and higher levels of antibodies are associated with higher vaccine efficacy. But antibodies are only one component of the body’s defense mechanisms against a covid infection.

When the antibodies decrease, the body compensates with a cellular immune response. “A person who has lost antibodies isn’t necessarily completely susceptible to infection, because that person has T-cell immunity that we can’t measure easily,” said Dr. Cody Meissner, a specialist in pediatric infectious diseases who sits on the FDA’s vaccine advisory panel.

John Wherry, director of the Penn Institute of Immunology at the University of Pennsylvania, recently published a study finding that the mRNA vaccines provoked a strong response by the immune system’s T cells, which researchers said could be a more durable source of protection. Wherry is working on a second study based on six months of data.

“We’re seeing very good durability for at least some components of the non-antibody responses generated by the vaccines,” he said.

For protection against serious disease, “really all you need is immunological memory, and these vaccines induce immunological memory and immunological memory tends to be longer-lived,” Offit said. Federal scientists also are studying T-cell response, Fauci said.

FDA Approval Needed

Pfizer and Moderna have said they think boosters for covid will be necessary. But it’s up to the government to authorize them. Federal officials say they are sifting through new data from the companies and elsewhere as it becomes available.

There’s not a deep playbook for this: Emergency use authorization, or EUA, of vaccines has been sparingly used. The FDA has already amended Pfizer’s prior EUA clearance twice, first in May to expand the vaccines to adolescents 12 to 15 years old and, again, this month to allow immunocompromised people to obtain a third dose. The FDA did not respond to questions about the process for authorizing widespread booster shots.

Pfizer announced in July that it expects $33.5 billion in covid vaccine revenue this year. Its stock has risen 33% this year, closing at $48.80 Thursday. Moderna reported sales of $5.9 billion through June 30 for 302 million doses of its vaccine. The company’s stock has skyrocketed 236% year-to-date, closing at $375.53 Thursday.

In applying for emergency authorization, the FDA requires vaccine manufacturers to submit clinical efficacy data and all safety data from phase 1 and phase 2 clinical trials as well as two months of safety data from phase 3 studies. For full approval, the FDA requires manufacturers to submit six months of data.

Pfizer this week announced it has submitted phase 1 clinical trial data to the FDA as part of an evaluation for future approval of a third dose. The company said phase 3 results are “expected shortly.”

Pfizer said its preliminary trial results showed a third dose was safe and increased antibody levels against the original virus and the delta variant. Moderna found a third dose had safety results similar to a second dose and produced a strong antibody response. 

Typically, any distribution of shots would occur after the CDC’s Advisory Committee on Immunization Practices also developed recommendations. But with the Biden administration’s announcement about boosters, public health experts worry the message suggests the outcome is preordained.

“They have completely and unfairly jammed FDA and ACIP. They’ve left them no choice. If there’s no booster program, FDA gets blamed and that’s not appropriate,” said Dr. Nicole Lurie, a former senior Health and Human Services official in the Obama administration and U.S. director of the Coalition for Epidemic Preparedness Innovations, the global epidemic vaccines partnership.

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

Electro-Medical Therapy Can Help Treat Intractable Pain

By Forest Tennant, PNN Columnist

To maximize relief and recovery from Intractable Pain Syndrome (IPS), it is advisable to employ one or more electro-medical (EM) therapies. All persons with IPS are highly encouraged to try a variety of EM therapies, but only as an adjunct or add-on to their current medical treatment.

Electric Current Devices

Electric current (EC) therapy is probably the best known of the EM therapies. Electric currents primarily have an anesthetic effect, much like a local anesthetic such as lidocaine. They anesthetize nerves or spinal cord nerve roots and provide temporary pain relief. In some cases, EC therapy may even bring about long-term pain relief because electric currents sometimes reset electrical conduction of nerves.

EC devices can vary, like light bulbs, in power and frequency. One advance is called “micro current.” This is a low power frequency in which the current can be transmitted through the earlobe or scalp to treat headaches or central pain.

Electric currents of various powers and frequencies are now combined in products and devices such as transcutaneous electrical nerve stimulators (TENS units), Calmare “Scrambler” therapy, and spinal cord stimulators. Devices with multiple currents usually bring a superior result compared to a single current device.

Unfortunately, only a therapeutic trial will tell you which EC therapy will help you. Many self-help TENS units are available for home use, and they should be tried. All persons who have IPS from a stroke or traumatic brain injury should consider a trial with micro-current therapy.

If you find an EC device that gives you relief, don’t use it every day. As with drugs, you may become tolerant, and the device will become ineffective. Give at least a day between treatments.

Electromagnetic Devices

Electromagnetic (EMT) devices are new to pain treatment and are quite different from EC devices because they use energy that is 50% electric and 50% magnetic. The energy is comprised of sub-atomic particles not usually visible to the naked eye.

EMT energy is generated by devices that manipulate the electric current that is found in every battery or household electrical socket. The energy is condensed into a wave that can be sent into human tissue with a transmitter wand, probe or plate. The energy wave can be administered in different frequencies and wave lengths that vary from a very slow, long wave to a very fast, short wave.

The three major types of EMT are laser, infrared and radio. Infrared is a low-frequency long wave, while radio has long, slow waves. Lasers can put out infrared waves, and also emit visible high energy frequencies which can cut, dissolve or ablate tissue.

In medical administration, long slow waves may penetrate several inches into the human body, while the short high frequency waves of laser and infrared will not normally penetrate human tissue by more than an inch. Some devices pulse the waves to get deeper tissue penetration. These devices are known as “Pulsed Electromagnetic Energy Frequency“ or PEMF.

Lasers may be able to totally remove or dissolve a pain “trigger.” For example, an experienced practitioner may be able to identify a pain trigger along the spine, or neuropathy in the face or extremity, and actually cure the condition with laser treatment.

Infrared is the most effective EMT for pain relief of a recent injury to the spine, joint or soft tissue. It is quite effective for contusions or joint swelling. Infrared can also help drive medication through the skin, so it is very effective if a cortisone cream is applied to the skin during infrared treatment.

Radio waves penetrate deeply. Their best use appears to be for spinal conditions, including herniated discs and other spinal inflammatory conditions, such as arachnoiditis. Deep penetrating radio waves will probably, at least in some cases, reach the interior of the spinal canal.

Major Take Home Point

Patients with IPS are constantly bombarded with the pitch that they need an electromagnetic “savior” such as an implanted electrical stimulator, or an expensive multi-electric current or electromagnetic course of treatment. The parties who sell and promote these devices are invariably unknowledgeable about the serious, relatively rare condition of IPS.

EC and EMT devices are made for acute or short-term pain and injury problems, not constant incurable pain with cardiovascular, endocrine and autoimmune complications.

Implanted electrical stimulators may be a “godsend” to some IPS patients, but they may not work or even cause more pain for others. This is why trials are done prior to implantation. The big problem is that there is so much money to be made with implanted stimulators that some unethical practitioners don’t tell you that they are mainly for breakthrough or flare pain.

There are many risks to implanted stimulators, so every IPS patient needs to remain on a 3-component medical program that combines suppression of inflammation, repair of damaged tissue and pain control.

Once you are on this 3-component protocol and have a good nutritional and physical program solidly in place, then give electromedical measures a try. Simple measures like water soaking or magnets may  also be very helpful. Electromagnetic administration is relatively new and shows great promise!

Forest Tennant is retired from clinical practice but continues his research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.    

Widespread Pain Raises Risk of Dementia and Stroke

By Pat Anson, PNN Editor

Widespread body pain caused by fibromyalgia and other chronic pain conditions raises the risk of stroke and dementia, including Alzheimer’s disease, according to a new study.

Researchers looked at health data for nearly 2,500 second generation participants in the long-running, community-based Framingham Heart Study. Participants in the “offspring” phase of the study were given a comprehensive check-up that included a physical exam, lab tests and detailed pain assessment when they enrolled in the early 1990’s. They were then reassessed every four years for signs of cognitive decline, dementia or stroke.

Over the next two decades, 188 of the participants were diagnosed with some form of dementia and 139 had a stroke.

While the number of cases was small, researchers found an association between pain and cognitive decline. Participants with widespread pain were 43% more likely to have some type of dementia, 47% more likely to have Alzheimer’s disease, and 29% more likely to have a stroke compared to those without widespread pain (WSP). 

“These findings provide convincing evidence that WSP may be a risk factor for all-cause dementia, AD dementia (Alzheimer’s), and stroke,” researchers concluded. “While it is known that chronic pain or persistent pain without detailed classification is associated with poorer cognitive performance in cross-sectional or cohort studies, our study was based on much more accurate assessments for pain at a longitudinal population level. The specific presence of WSP… has long-term implications for dementia and AD.”

The researchers said there were three possible explanations for the link between pain and cognitive decline. First are lifestyle factors associated with pain, such as reduced physical activity, poor diet, alcohol and weight gain. Second is that stress caused by widespread pain may impair cognitive function; and third is that WSP may be a “preclinical phase” of dementia and AD.

Previous studies have also linked chronic pain to dementia. A large 2017 study found that older people with chronic pain experience faster declines in memory and are more likely to develop dementia. A more recent study suggests that people with chronic pain are at higher risk of memory loss and cognitive decline if they have lower levels of education, income and access to healthcare.

Antidepressants, anti-psychotics, antihistamines and other common medications may also cause confusion and disorientation that is mistaken for dementia, especially in older adults. When patients are taken off the drugs, their cognitive function may improve.  

Previous studies have also linked widespread pain to cancer, peripheral arterial disease, cardiovascular disease and increased mortality.

Stem Cell Marketers Sued for Misleading Health Claims

By Pat Anson, PNN Editor

The U.S. Federal Trade Commission and the Georgia Attorney General are suing the co-founders of the Stem Cell Institute of America for marketing misleading health claims to seniors about stem cell therapy.

The agencies’ 40-page complaint against chiropractors Steven Peyroux and Brent Detelich alleges they promoted stem cell treatments nationwide through deceptive marketing schemes with other chiropractors and healthcare providers.

The promotions claimed that stem cell injections were superior to surgery, steroids and pain medication in treating arthritis, joint pain and other orthopedic conditions. The injections cost as much as $5,000 per joint, with patients often getting multiple injections.

“These defendants advertised expensive stem cell injections with baseless pain-relief claims, and provided marketing materials and training to chiropractors to do the same,” Samuel Levine, Acting Director of the FTC Bureau of Consumer Protection, said in a statement.

“At best, the use of unproven products or therapies can cost consumers thousands of dollars without affording them any results,” said Georgia Attorney General Chris Carr. “At worst, it can be harmful to their health. Our office will continue to hold accountable businesses that make unsubstantiated claims and violate the law – especially those that target our older or at-risk adults.”

Peyroux and Detelich founded the Georgia-based Stem Cell Institute of America (SCIA) in 2015 and operated under various business names, including Regenerative Medicine Institute of America, Superior Healthcare and Physicians Business Solutions.

According to the Georgia Attorney General’s Office, the companies “generated millions of dollars in revenue” by advising chiropractors around the country how to add stem cell therapy to their practices. It also trained them how to recruit new patients, and provided marketing and advertising material.

One newspaper ad invited patients to attend a free seminar where they could learn how stem cell therapy “can change your life” and stop their joint pain “without costly and painful surgery.”

SCIA also had its own YouTube channel, where videos pitched stem cells as “one of the most cutting-edge noninvasive and nonsurgical treatments for joint and arthritis pain.”

The complaint alleges that SCIA conducted no clinical testing to demonstrate its advertised claims and that no scientific studies supported them. The complaint also alleges the defendants violated Georgia’s Fair Business Practices Act related to the distribution of false or misleading information.

STEM CELL INSTITUTE AD

SCIA, Regenerative Medicine Institute of America, and Superior Healthcare filed for Chapter 7 bankruptcy protection in 2019.  

Physicians Business Solutions continues to operate and recently hosted a training seminar for chiropractors in Atlanta. It is scheduled to hold another seminar in October at the Trump Hotel in Chicago. The company did not respond to a request for comment.

A Pained Life: Do You Know the Magic Words?

By Carol Levy, PNN Columnist

My chronic pain started with a spontaneous, horrific and sharp pain, like a blade slicing through my left temple. Within two weeks, I was disabled by it. Almost everything triggered the pain, even the tiniest wisp of hair or whisper of a breeze.

I was 26 at the time. I could only afford to go to a local hospital clinic. No matter which doctor saw me or their specialty, no one could figure it out.

Then I started dating Scott, one of the ophthalmology residents. On our date, Scott kept trying to touch the left side of my face. I kept pulling away.

“Where shouldn’t I touch you?” he asked.

I mapped out the area on the left side of my face, from my scalp down to my cheek. The exact same area I indicated at all of my clinic visits. Scott looked shocked.

“I know what you have. You have trigeminal neuralgia,” he said.

I knew of the horrors of this pain. I didn't want this diagnosis. But at least now I had a name for it.

Fast forward to when I could afford a private doctor. I went to see a neuro-ophthalmologist and told him my story. Feeling anxious and afraid, I related it in a manner that may not have been very coherent as it might otherwise have been.

“Don’t be so schizophrenic,” the doctor said. “Tell me what happened more clearly.”

He decided I was “anxious” and that was probably the cause of my pain. He told me to come back in three months and see if anything had changed by then.

I didn’t want to go back, but what choice did I have? It turned out to be a very good decision.  It was at this appointment I learned that “magic words” exist in the medical world.

“Is the pain the same?” the doctor asked. When I said yes, he said to come back in another three months.

I was walking to the door when a thought hit me. “You know for a few seconds today I thought it was finally over,” I said. He immediately perked up

“What made you think that?” he asked.

I was on the train and a lady had brushed against my face. And the pain didn’t come right away. I was happy for abuut 20 seconds, when the pain hit me like a sucker punch.

“It’s time we brought you into the hospital,” the doctor said. “We need to do some tests.”

I had no way of knowing, but I had uttered the magic words. Unbeknownst to me, that specific change was a distinct sign of trigeminal neuralgia. 

How many times have we gone to the doctor and gotten the “I dunno” or “I don’t understand your complaint” answer? 

I have a feeling for many of our disorders there are magic words like “abracadabra” or “open sesame” that change the way doctors see us. The sad part is there is no good way to figure them out. Do too much research and you may get labeled a hypochondriac. Do none and you'll never know the secret words. Is there a middle ground? 

It reminds me of the fairy tale Rumpelstiltskin, about an imp who spins straw into gold in exchange for a girl's firstborn child. If the girl guesses his name within three days, she could keep her baby. She does, and Rumpelstiltskin goes away. 

For many of us, if we guess the right words, we get the right tests, the right diagnosis and maybe even the right treatment. If only it wasn’t a fairy tale.

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.

State Laws Reduced Number of Days Opioids Prescribed

By Pat Anson, PNN Editor

State laws that limit initial opioid prescriptions to seven days or less have reduced the number of days that opioid medication is prescribed to Medicare patients for short-term acute pain, according to a new study.

Nearly two dozen states implemented laws limiting the initial supply of opioids after the CDC released its 2016 opioid prescribing guideline. Seventeen states limited prescriptions to 7 days, two states capped them at 5 days, and four states limited prescriptions to just 3 days.  

“The state legislation on opioid prescribing primarily targets initial opioid prescriptions provided for acute pain, and we observed decreases that were most pronounced among surgeons and dentists,” wrote John Cramer, MD, an assistant professor at Wayne State School of Medicine and lead author of the study published in JAMA Internal Medicine.   

Cramer and his colleagues found that state laws capping initial opioid prescriptions were associated with an average reduction of 1.7 days in supply for each Medicare patient. Prescribing also fell in states without such laws, although not as much. Despite the declines, the study concluded that “excess opioid prescribing” was still prevalent among all patient populations.

The caps on duration were imposed to reduce the initial exposure of patients to opioids, with the goal of reducing the potential for diversion, addiction and overdose. The researchers did not examine whether those goals were achieved or if patients were satisfied with their pain relief.

“Because this study used administrative data, we do not know how the patients did — was their pain adequately controlled, did they have adverse effects from the opioids, did they have trouble renewing a prescription, or continue to take opioids months later?” asked Deborah Grady, MD, and Mitchell Katz, MD, in a JAMA editorial.

Grady and Katz said it was reasonable to limit initial prescriptions to seven days, but they are concerned about imposing stricter limits on opioids.

“We worry that restricting initial prescriptions to shorter periods, such as 3 or 5 days, as occurred in 6 states in this study, may result in patients with acute pain going untreated or having to go to extraordinary effort to obtain adequate pain relief,” they wrote. “We think the data in this study suggest that limiting initial prescriptions to 7 or fewer days is helpful, but we would not restrict any further given that we do not know how it affected patients with acute pain.”

It’s not just states that have imposed limits. Some insurers and pharmacy chains have also adopted policies that put caps on first-time opioid prescriptions.

A federal bill that would have limited initial opioid prescriptions to just three days nationwide was amended earlier this year after complaints from patient advocates. The new version of the Comprehensive Addiction and Recovery Act (CARA) contains no limits on the number of days opioids can be prescribed. Congress has not acted on the bill yet.

10 Reasons for Lawmakers To Oppose Limits on Rx Opioids

By Matthew Giarmo, PhD, Guest Columnist

1. Government Leaders Have a Choice

History may record one day that politicians and policymakers had a choice: They could champion the rights of 50 million Americans in chronic pain who desperately need a hero or they could be scorned for unnecessary cruelty and playing politics with people's pain.

The gathering storm is a backlash to the heightened regulatory and surveillance culture that has commandeered our nation’s healthcare system. It will not go unanswered. We no longer allow government into our bedrooms to police sexual behavior, gender identity and abortion rights. And we sure as hell will not allow government to spy on our doctors and medicine cabinets.

The government has blood on its hands from chronic pain patients resorting to suicide and street drugs after being abandoned by physicians who fear imprisonment by DEA agents who have no medical training or patient knowledge.

2. Opioids Misunderstood

Opioids are not only cheap; they are uniquely effective in restoring quality and functionality to millions of Americans who suffer from chronic or intractable pain. Opioid medication is safe when used properly, while long term use of ibuprofen and acetaminophen is toxic.

When we examine data on efficacy, toxicity, dependency, teen use, mortality and preventable causes of death, opioids do not warrant consideration as a threat to national health security. There is no opioid "crisis" or "epidemic."

I believe any determination to the contrary is a byproduct of inappropriate agency regulation (the 2016 CDC Opioid Guideline) and biased and conflicted advice from an extremist sect (Physicians for Responsible Opioid Prescribing) operating at the fringes of the medical community. The growing realization among doctors and patients is that "the fools are in charge" and "the foxes are guarding the hen house.”

Inappropriate prescribing that resulted in spikes of opioid abuse, such as pill mills and dentists disposed to trade 60 Percocet for wisdom teeth, ended several years ago. So did the marketing of extended-release formulations like OxyContin.

3. Junk Science

You may have been seduced by contrived overdose statistics (“500,000 people died from an opioid overdose”) that remain viral, despite the CDC itself acknowledging that 48% of deaths due to illicit fentanyl were erroneously counted as deaths due to a prescription opioid.

When we break down the politically convenient and alarmist statistics into deaths involving polysubstance use, suicide, reckless dosing out of frustration with pain, and drugs that were never prescribed to the decedent, the 125 deaths per day initially claimed by the CDC looks more like 5 deaths a day.

It would be more appropriate to attribute these fatalities more to pain itself than to pain medication, as well as drug experimentation, depression or diversion. Most of those who abused OxyContin reported never having a valid script. That is no basis on which to separate chronic pain patients from their medication.

But as long as an opioid shows up in a post-mortem toxicology screen, deaths are being classified as an opioid overdose; even when the opioid was one of several drugs consumed, when it cannot be determined whether the opioid was consumed in a medically relevant way, and even when the decedent was hit by a bus.

The overdose numbers had to be gamed, which makes sense when you consider that in 70% of cases, rulings on causes of death are made before the toxicology data is even available. Especially when you consider that those sky-high opioid fatalities seem out of step with the low rates of dependency (6% for chronic pain patients, 0.7% for acute pain and less than 0.1% for post surgical pain).

As a social psychologist, government analyst and research critic, I have identified about a dozen ways the science of opioids has been corrupted for financial gain, professional survival or advancement, and in service of a political cause.

One example is the claim that “80% of heroin users first misused prescription opioids.” That canard was violently ripped from a SAMHSA report and is misleadingly used to imply that 4 in 5 patients prescribed painkillers eventually use heroin. On the contrary, less than 4% of prescription opioid users turn to heroin. 

Incidentally, 67% of heroin addicts reported that their prior use of prescription painkillers had not occurred in the past year. Hardly seems like an irresistible urge to me.

4. Not Knowing When to Say When

Much like Sen. Joe McCarthy wreaked havoc on a nation with reckless claims about communist infiltrators, opioid McCarthyism is killing our most vulnerable and innocent populations -- veterans, senior citizens, persons with disabilities and the chronically ill.

Regulations complicate and delay the dispensing of legal scripts for these patients at the pharmacy, creating a "what's-it-gonna-be-this-time" syndrome in which patients endure a new burden every month.

Prescriptions for opioid painkillers have declined 40% since 2011, while overdoses on heroin and illicit fentanyl have soared. As National Public Radio falsely reported that doctors are “still flooding the U.S. with opioid prescriptions,” solid research offers definitive evidence that prescriptive austerity is helping to drive the spike in overdose fatalities.

A recently published study found that among 113,000 patients on long-term opioid therapy, the incidence of a non-fatal overdose among those subjected to tapering was 68% higher than those who were not tapered. The incidence of a mental health crisis such as depression, anxiety or attempted suicide was 128% higher among those who were tapered.  

5. The Inherent Absurdity of MME Thresholds

Forced tapering is undertaken to achieve an arbitrary one-size-fits-all threshold that makes no sense. There is no basis in science or nature for determining how much medication is too much. As long as patients are started at the lowest effective dose and titrated up gradually, as dictated by unresolved pain and any side effects, there is no limit to how much a patient might need 5, 10 or 15 years downstream.

Arbitrary dose limits defined in terms of morphine milligram equivalents (MME) ignore the importance of individual differences in medical diagnosis, treatment history (tolerance), and enzyme-mediated (genetic) sensitivity to pain and to pain medication. MME thresholds falsely assume that all opioids are equal and impact all patients the same way.

MMEs may be convenient for bureaucrats and expedient for politicians, but their scientific utility -- and by extension the CDC guideline itself -- is nullified by differences in the half-life of different drugs, differences in their absorption into the bloodstream, and differences in their rate of metabolism in different people.

6. Without Liberty or Justice for All

For arguments sake, let us suppose that we lose as many souls to prescription opioids as we do to car accidents. What have we done to rein in this other preventable cause of death? We create laws requiring safety belts, air bags, annual inspections, and compliance with speed limits. We do not criminalize the sale, operation and distribution of Honda Civics. We do not restrict the number of cars on the road. And we do not drop DEA teams behind enemy lines in Detroit.

But at a time when Americans are growing weary with a drug war that has lasted longer than our wars in Vietnam and Afghanistan -- and when Americans have softened their views on marijuana -- the DEA, perhaps in a desperate search for new bogeymen, expanded its theater of operations to treat pharmaceutical companies as drug cartels, doctors as dealers, and patients as addicts.

As we speak, your state is creating a mini-DEA inside its Department of Health or Medical Board that weaponizes the Prescription Drug Monitoring Program as a surveillance and detection tool, to spy on and red flag each patient and doctor whose script or “NARX Score” exceeds an arbitrary limit for which no basis in science or nature exists.

Think about all the sacred ideals we’ve abandoned to support our failed effort to bring a specious “opioid crisis” under control: the Constitution; a compassionate care system that had been the cornerstone of a civilization; a physician’s right to exercise clinical judgement; their right to due process; and a system of individualized, patient-centered care.

Government is obliged to ease civil unrest -- not foment it. But federal and state governments are hell bent on driving wedges between groups of stakeholders: physicians against patients; patients and physicians against pharmacists; patients against the public at large; physicians against their own office staffs; patients against employers; and physicians against medical boards. That is McCarthyism.  

All too commonplace on social media are acrimonious altercations between the grieving survivors of overdose victims and those caring for friends or family living with chronic pain. There's no reason we can't simultaneously provide the medicine, assistance and requisite sympathy to Americans who need addiction treatment and Americans who need pain medication -- especially when we consider that only 6% of chronic pain patients prescribed painkillers develop dependency.

The NARX Score itself, a deeply flawed hotdog of a composite that ostensibly assigns a number to a person based on their supposed risk of overdose, is morally and intellectually offensive. It does little to assuage those who use the term “pain patient genocide" and compare it to the demonization and murder of 11 million Jews, gypsies, homosexuals and criminals in Germany during the Second World War.

7. Opioid Crisis As a Scapegoat

Have we as a nation become more addicted to the "opioid crisis" than we ever were to opioids? For our nation’s leaders, opioids have become an irresistible diversion and scapegoat. It’s a means to repair a tarnished reputation (see Chris Christie) or display rare bipartisan unity to disarm a cynical and frustrated constituency.

In a striking reversal of cause and effect, government officials would have you blame opioids for the loss of jobs, identities, finances and relationships that have come to define life in 21st century America. In reality, we have two crises: a crisis of chronic pain estimated to involve 50 million Americans and a psychosocial crisis linked to the combined effects of economic disparity, globalization, automation, immigration, social media, terrorism, pandemics, and the dissolution of national unity into political sects and interests.

Opioid critics like to point out that opioids only mask painful symptoms rather than address the underlying cause. But isn’t that what government officials do when they attempt to conceal or compensate for the true ills of our nation by playing whack-a-mole with prescription pain relievers?

8. The One-Track Mind

Last year a record 93,331 Americans died of a drug overdose, the vast majority involving illicit fentanyl and other street drugs, not prescription opioids.

We observed a 190% rise in cocaine overdoses and a 500% rise in overdoses involving methamphetamine. We have also seen increases in the abuse of alcohol and OTC substances like dextramorphan, diphenhydramine, ibuprofen, acetaminophen and loperamide, a drug used to treat diarrhea.

How many of those deaths can we blame on Purdue Pharma? Will collecting billions of dollars in settlement money from opioid distributors solve our overdose problem? Or will it enrich plaintiff law firms just like the Tobacco Settlement did?

9. An Unfair Fight

I was inspired to write this by a family -- MY family. I know what it’s like to see a patient’s treatment plan forcibly altered and how it affects not only the patient, but all those who cherish and depend on them. Children get less attention. Spouses assume a greater share of household responsibilities. Employers deal with lower productivity.

This memo and a lengthier report will go out to families and physicians across the country with the aid of hundreds of patient-advocate communities I mobilized on social media platforms. Still, it hardly seems like a fair fight. The meek of the Earth versus an army of federally funded Type A regulators and paid expert witnesses falling over one another to advance their careers and pad their bank accounts by making life harder for people to treat their pain.

10. Taking the Battle to the States

You may decide against reading my report, but you will likely hear about it from peers, co-workers or constituents in the months to come. It is making the rounds. State legislatures. Medical boards. Medical associations. Patient advocacy groups. Defense attorneys (I was twice asked to serve as an expert witness by physician counsel). Federal agencies.

In the past two weeks, my associates have disseminated my report to the American Medical Association, AARP, federal and state officials, members of Congress and the White House.

I invite readers to do the same by downloading my report, “There Is No Crisis.” We’re just getting started.

Matthew Giarmo, PhD, is a social psychologist who has worked with terminally ill cancer patients. Matthew authors research-based reports in social phenomena, including the impact on workforce development of the Software Revolution and Great Recession, and the degradation of science by professional and institutional requirements. 

My Migraine Journey: From Electrodes to Cannabis

By Gabriella Kelly-Davies, PNN Columnist

The room swirled as my eyes fluttered open, and I could feel something tight around my neck. It felt like a vice, making it difficult to swallow. The antiseptic smell was familiar, but I couldn’t quite place it. Struggling to focus my eyes, I heard a voice I knew well — it was Ben, a doctor at the hospital where I worked as a physiotherapist.

“How do you feel?” Ben said, shining a bright torch into my eyes.

“Where am I?”

“You’re in emergency. An ambulance brought you here. You were lying on the side of the road, unconscious.”

Ben told me the ambulance officers had received reports of cyclists being pushed off their bikes at the quieter end of the beach. They assumed that’s what had happened to me.

That day, my twenty-fourth birthday, heralded the onset of a life of migraine attacks.

Gabriella Kelly-Davies

During the 1990s, I regularly traveled around Australia for work while studying business at night. In the plane as I read my textbooks, a pain like an electric shock would shoot up the back of my neck and head.

It lasted for several minutes, then a deep ache started in the base of my skull. The pain eventually spread upwards, fanning out until it covered the entire back of my head and temples.

All too soon, the pain I experienced while flying became more regular and was most severe after sailing and playing my piano or cello. Cycling and tennis also triggered it.

In 1996, I started a job in Parliament House, Canberra as a policy adviser to a senior politician. Mid-morning, I would feel shooting pains running up the back of my head, accompanied by waves of intense nausea. Soon afterwards, a deep ache in the base of my skull started, quickly spreading up over my head and into my temples. My eyes felt gritty, as if they were full of sand, and I yearned for them to explode to release the mounting pressure inside them.

Often when the pain was at its worst, I couldn’t think of the words I wanted to say, infuriating some colleagues. Sometimes I couldn’t string two words together coherently. My mouth refused to form the words I wanted to say, as if the messages weren’t getting through from my brain to the muscles in my face.

The Merry-Go-Round

Returning to Sydney in 1999, I despaired of ever being free of pain and nausea. I consulted an endless round of specialists and health professionals, but none of them helped much. I felt overwhelmed by head and neck pain and a general sense of ever-increasing pressure inside my head and eyes. I fantasized about boring a hole through the base of my skull with an electric drill to release the tension.

Between 2000 and 2005, I progressively stopped doing all the things I most loved because they triggered migraine attacks. My goal became getting through a day of work, returning home and lying in a dark room with a series of ice packs under my neck.

Anxiety about being stigmatized and the intolerance I perceived in some colleagues at work prevented me from admitting I was in pain. Instead, I worked like a Trojan to ensure I maintained a high level of performance and no one could accuse me of using pain as an excuse to under-perform.  

While on the endless merry-go-round of seeking solutions, I ended up at the Michael J. Cousins Pain Management and Research Centre in Sydney. Dr. Cousins and a team of health professionals assessed me. They diagnosed occipital neuralgia, a form of headache that can activate migraine attacks. I had chronic pain, a malfunction in the way the nervous system processes pain signals.

The team suggested an experimental treatment. It involved implanting tiny electrodes into the back of my head and neck to block the pain signals from traveling along the nerves in my head. I agreed to the surgery and afterwards; I had fewer migraine attacks than previously. I even had a few completely pain-free days.

One year later, I felt something sharp sticking out from the base of my skull. My pain specialist discovered an electrode wire protruding through the skin. Tests revealed the electrodes were infected, so they were removed. Afterwards, migraine attacks returned in full force.

Three months later, new electrodes were implanted, but they didn’t work as well, possibly because scar tissue blocked transmission of the electric current. Still, overall I was better than before the initial surgery. I worked full time and sang in a choir at Sydney Opera House.

Disappointingly, disaster struck in 2008. A superbug infected the electrodes, forcing my doctor to remove them. Once the infection cleared and the electrodes were re-implanted, they were only partially successful, and my life returned to its pre-electrode state.

Multidisciplinary Pain Management

A significant turning point occurred in 2009 when I participated in a three-week multidisciplinary pain management program. Each day, a team of pain specialists gave lectures on topics such as chronic pain and how it differs from acute pain. The physiotherapists started us on a carefully graded exercise program, and a psychologist taught us cognitive behavioural therapy techniques to help us change the way we thought about and dealt with pain. Surprisingly, the exercises didn’t cause a flare-up and at last I felt as if I was making progress.

The pain management program taught me to stop catastrophizing and to believe I had the power to change how I reacted to pain. For years, I practiced the stretches and strengthening exercises every night after work. I also applied the psychological techniques, and they became central to my daily routine.

Twelve years later, I continue to live with migraine. I’ve tried several migraine preventatives, but none helped. Eight months ago, I started taking medicinal cannabis and it has significantly reduced the frequency and severity of migraine attacks.

Over the years I’ve learned to reduce the impact of migraine on my life by using techniques such as mindfulness meditation and carefully paced exercise that turn down the volume of pain signals racing through my malfunctioning nervous system.

Chronic pain is complex and difficult to treat but it is possible to live well with pain. I encourage you to do a multidisciplinary pain management program and continue your search for approaches that reduce the impact of pain on your life.  

Gabriella Kelly-Davies is a biographer and studied biography writing at the University of Oxford, Australian National University and Sydney University. She recently authored “Breaking Through the Pain Barrier,” a biography of trailblazing Australian pain specialist Dr. Michael Cousins. Gabriella is President of Life Stories Australia Association and founder of Share your life story.

The Fentanyl Exposure Myth Must End

By Roger Chriss, PNN Columnist

There is a pervasive belief that exposure to even a speck of illicit fentanyl can be immediately life-threatening. The most recent example is a story from USA Today.

“Dramatic body camera footage shows that a sheriff’s deputy in California nearly died after being exposed to fentanyl at an arrest last month,” the story begins, explaining that Deputy David Faiivae collapsed after finding a “white substance” in the trunk of a suspect’s car on July 3.

Faiivae appears to be revived by his training officer with a nasal spray of naloxone, an anti-overdose medication. The body camera video of the incident was so dramatic, the San Diego County Sheriff’s Department turned it into a training video:

There are reasons to be cautious with stories like this. Fentanyl is a potent synthetic opioid responsible for tens of thousands of overdose deaths, but experts say it’s not nearly as dangerous as it is often portrayed.

"You can't just touch fentanyl and overdose," Ryan Marino, medical director for toxicology and addiction at University Hospitals in Cleveland told NBC News. "It doesn't just get into the air and make people overdose.

"We have a lot of scientific evidence and a good knowledge of chemical laws and the way that these drugs work that says this is impossible."

Casual contact with fentanyl is not generally life-threatening. As Marino explains in a guide for first responders, fentanyl powder is not absorbed through the skin and powdered opioids do not aerosolize.

This is a well-founded view. Drs. Lewis Nelson and Jeanmarie Perrone wrote in STAT News that “there is clear evidence that passive exposure to fentanyl does not result in clinical toxicity.”

But stories of passive exposure to fentanyl being life-threatening are becoming more common. Google Trends shows a rapid uptick from 2017 onward after media coverage of an Ohio patrol officer supposedly overdosing on fentanyl after brushing a bit of powder from his shirt.

According to a 2020 study in the International Journal of Drug Policy, there were 551 news articles in 48 states about casual contact with fentanyl from 2015 to 2019. The reports received about 450,000 Facebook shares, potentially reaching nearly 70 million people.

“Fueled by misinformation, fentanyl panic has harmed public health through complicating overdose rescue while rationalizing hyper-punitive criminal laws, wasteful expenditures, and proposals to curtail vital access to pain pharmacotherapy,” the study found.

If passive exposure to fentanyl were as risky as media and law enforcement suggest, wouldn’t there be a flood of bodies from illicit drug operations? Drug labs do not operate with robust safety measures and street dealers handle drugs in ways that would make passive exposure inevitable. Deaths result when fentanyl is ingested, not from casual contact.

The misperceptions of passive exposure risks are impacting law enforcement, emergency services and medical care. As a result, pharmacy professor Lucas Hill joined with Marino and others to write an open letter this week to media outlets called “Retraction Request for Dangerous Drug Misinformation.”

“We are issuing this letter to request a retraction and correction of your recent article which perpetuates a myth: that casual contact with potent synthetic opioids such as fentanyl poses a health risk to first responders. This is dangerous misinformation that can cause harm both to people who use opioids and to members of the law enforcement community. We greatly appreciate your cooperation in addressing this error.”

The letter is the latest attempt to reduce the harms of media misinformation about drugs. But as with so many things involving drugs, mythology drives too much of the media and law enforcement narrative.

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.   

The Ever Changing Rules of CRPS

By Cynthia Toussaint, PNN Columnist

Two weeks ago, writhing at a level 10 pain, struggling to position my heating pad just right for a moment of relief, I told God that if it was time to take me, that was okay.

I thought I knew the rules of Complex Regional Pain Syndrome. After nearly four decades of trying to sidestep the burning torture, making every attempt to not poke the bear, I was confident I’d cracked the code enough to ward off any long-term flare. The kind that makes you think about dying.

But a shot of emotionally heightened experience, a jigger of COVID vaccine, and a splash of post-chemo recovery combined to turn the rules on their head. I think.

No question, I needed to see my mom. Due to my bout with aggressive breast cancer, a once-in-a-century pandemic, toxic family members and my mom’s advanced Alzheimer’s, I hadn’t seen her in a year and a half. When COVID loosened and I discovered she’d been placed in a nursing facility, a window of opportunity opened for a possible visit without seeing family members that harm and hurt.

The heavens opened and I got to spend a glorious day with an angel disguised as my mom.

But before that, wheeling up to the facility, my profound dread leapt to the nth degree, fearful that I might be facing a firing squad made up of familial cruelty. That, along with the emotional elation of time together with Mom – loving each other through her scattered cognition – sent waves of arousal through my nervous system, sparking over-the-moon pain as my partner, John, and I made our six-hour return trek to LA.

Over the next days, then weeks, as my pain maintained its grip, I knew in my gut this flare was something altogether new and terrible. But why? As I learned long COVID was inciting cytokine storms of pain and fatigue, and that many of my vaccinated sisters in pain were experiencing epic flares, I postulated that the vaccine (which had already re-erupted chemo side-effects) was probably the secret sauce for my exquisite agony. 

Without a doubt, this is the worst CRPS flare I’ve had in 35 years – and that one from the Reagan 80’s left me using a wheelchair to this day. Imagine my fear of what I might lose this go around. I’ll tell you, it’s soul-shaking.

In the past when I’ve experienced bad flares, my doctors have encouraged me to temporarily go up on gabapentin (Neurontin), a nerve medication I’ve taken for many years with good results. Because I despise taking drugs and never trust the “temporary” part, I’ve always resisted increasing the dose. That is, until now. Truth be told, a month into this flare, it took only a nudge from my doctor to increase my daily gabapentin in-take by 300mgs.

What a mistake. Fair to say, while the increase lowered my pain level by about three points, a HUGE improvement, the side effects were scorched-earth. I was wiped out to the point of being barely functional. This “never-a-napper” was falling asleep mid-day and I would wake with dementia-level disorientation. John had to remind me what day it was, where I lived, and what was happening in our lives.

I also suffered with suicidal ideation, compulsive thoughts, depression, joint pain, constipation, blurry vision and spatial difficulties. I’d traded one hell for another.

On the fourth night, I turned in bed and woke to the room (or was it my head?) spinning. The vertigo alerted me to the fact that if I continued this drug increase, I’d likely fall – and that could be catastrophic.

The next morning, with my doctor’s consent, I went off the extra gabapentin and, in its place, started Alpha Lipoic Acid. I took this supplement during chemo to ward off neuropathy, and it did the trick without side effects. Okay, to be fair, I wasn’t aware that it made my urine smell like burning tires as the chemo drugs masked that little nugget. Sorry, John.

That night, I experienced my worst pain ever, but, again, why? Even more confusing, I woke with honest-to-goodness relief, the last thing I expected. In fact, for the first time in weeks, I didn’t describe my morning swim as torture. As of this writing, the relief is holding, though threatening to return to the “I’m ready to die” level. But now, I have a taste of hope.

Still, I’m exhausted, scared and confused.

This is the essence of CRPS. It can come and go with little apparent cause. It can hide and seek, and its rules of engagement are ever shifting, ever evolving. It’s a devil that pokes its white-hot pitchfork of torture whenever, wherever it feels the urge. It’s crazy-making.

For all this madness, for all the uncertainty about my hell flare, these things I know for sure.

I did the right thing by getting the vaccine. COVID, or one of its variants, would (still might) kill me. I’m also doing my part to end this pandemic.

Chemo saved my life. While I’m betting it’s playing a hand in my current suffering, and will most likely present unknown damage down the line, I would not be alive without it.  

I was right to see my beautiful mother. I don’t know how much time either of us has, as I’m still a few years from “free-and-clear.” For my remaining days, I’ll always recall her reaction upon recognizing me, crying out my name and holding me so very tight. As my wonderful friend, Irene, reminds me, Mom and I have an epic love.  

Mom taught me to love myself, too. And I do. Completely. That love extends unconditionally to my CRPS, as it’s a part of me as much as anything is.

39 years into my dance with this mercurial disease, I doubt I’ll ever get ahead of it as its mystery and misery run too deep. Still, I can love it completely without complete understanding.

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 20 co-morbidities for nearly four decades, and became a cancer survivor in 2020. Cynthia is the author of “Battle for Grace: A Memoir of Pain, Redemption and Impossible Love.”

Pioneering Neurologist and CRPS Expert Remembered

By Pat Anson, PNN Editor

A pioneering neurologist who helped develop new treatments for Complex Regional Pain Syndrome (CRPS) has died. Robert Schwartzman, MD, passed away last week at the age of 81.

Dr. Schwartzman was an emeritus professor and former chair of the Department of Neurology at Drexel University College of Medicine in Philadelphia. He also taught and practiced medicine at Thomas Jefferson University, University of Texas Health Science Center, San Antonio and the University of Miami. He mentored hundreds of residents and colleagues, and authored several reference books on neurology.

The primary focus of Schwartzman practice and research was chronic pain, particularly CRPS (also known as Reflex Sympathetic Dystrophy or RSD), a chronic and severe pain syndrome affecting the nervous system.

At Jefferson University, Schwartzman founded the first CRPS clinic in the U.S. and pioneered the use of ketamine as a treatment for CRPS and other pain conditions.

“I met Dr Schwartzman in 2007 at a pain conference and joined the wait list to see him as my provider for RSD. I was finally able to so do in 2009. I shared what I learned with as many people as I could and continue to this day,” says PNN columnist Barby Ingle, founder and president of the International Pain Foundation. “His impact will live on through patients like me.”

DR. ROBERT SCHWARTZMAN

Ingle wrote about her first experience as a patient of Schwartzman in a PNN column. She went into the hospital in a wheelchair, but was able to walk out a week later after a series of ketamine infusions. She continues to get infusions regularly.

“He was a brilliant doctor and world expert on Reflex Sympathetic Dystrophy who's training and 40+ years of research help teach other providers who have also gone on to help millions of patients,” Ingle said in an email. “He will forever live in my heart as he is the provider who got me from my wheelchair and bed bound to walking and living life to my fullest. I will continue sharing his pioneering works and receiving his protocol for my infusion therapy. He is a treasure to our whole community.”   

“I didn't know him personally but I knew and respected his pioneering work,” says Lynn Webster, MD, past president of the American Academy of Pain Medicine. “He challenged our thoughts and understanding about how to treat the devastating disease of CRPS.  

“Dr. Schartzman took us into unexplored areas of how to treat a crippling disease. His work inspired me and countless others who have tried to implement his treatment approach for our own patients. He has given us a legacy of research that will be the foundation on which new discoveries about the mechanism and cure for CRPS will occur. The passing of Dr. Schwartzman is a huge loss for science and humanity.”

Schwartzman retired from clinical practice in 2013 and moved to Marco Island, Florida. Funeral arrangements are private. His family requests that any donations in his memory be made to any Florida wildlife or conservation charity.

Sales Reps Assist Surgeons During Implant Operations

By Fred Schulte, Kaiser Health News

Cristina Martinez’s spinal operation in Houston was expected to be routine. But after destabilizing her spine, the surgeon discovered the implant he was ready to put in her back was larger than he wanted to use — and the device company’s sales rep didn’t have a smaller size on hand, according to a report he filed about the operation.

Dr. Ra’Kerry Rahman went ahead with the operation, and Martinez awoke feeling pain and some numbness, she alleges. When Rahman removed the plastic device four days later and replaced it with a smaller one, Martinez suffered nerve damage and loss of feeling in her left leg, she claims.

Martinez is suing the surgeon, implant maker Life Spine Inc., and its distributor and sales representatives, alleging their negligence led to her injuries because the right part wasn’t available during her first surgery. All deny wrongdoing. The case is set for trial in November.

The lawsuit takes aim at the bustling sales networks that orthopedic device manufacturers have built to market ever-growing lines of costly surgical hardware — from spinal implants to replacement knees and artificial hips commonly used in operations. Sales in 2019 topped $20 billion, though covid-19 forced many hospitals to suspend elective surgeries for much of last year.

Device makers train sales reps to offer surgeons technical guidance in the operating room on the use of their products. They pay prominent surgeons to tout their implants at medical conferences — and athletes to offer celebrity endorsements. The industry says these practices help ensure that patients receive the highest-quality care.

But a KHN investigation found these practices also have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability and whistleblower lawsuits filed over the past decade.

Some patients allege they were injured after sales reps sold or delivered wrong-size or defective implants, while others accuse device makers of misleading doctors about the safety and durability of their products. Six multi-district federal cases have consolidated more than 28,000 suits by patients seeking compensation for injuries involving hip implants, including painful redo operations.

In other court actions, patients and whistleblowers repeatedly have accused device companies of failing to report injury-causing defects to federal regulators as required — or of doling out millions of dollars in illegal kickbacks to surgeons who agreed to use their products. Device makers have denied the allegations and many such cases are settled under confidential terms.

‘Inundated With New Implants’

At least 250 companies sell surgical hardware, and many more distribute it to doctors and hospitals across the country. Spine companies alone obtained more than 1,200 patents for devices in 2018, according to an industry report. Many come to market through a streamlined Food and Drug Administration process that approves their use because they are essentially the same as what is already being sold.

“In orthopedics, we are inundated with a multitude of new implants that debut each year,” Dr. James Kang, chairman of the orthopedic surgery department at Brigham and Women’s Hospital, remarked at a Harvard Medical School roundtable discussion published in 2019.

Kang said surgeons often rely on industry “reps” in the operating room for guidance because it is “usually burdensome and difficult” for surgeons to know “all of the intricate details and nuances” of so many products.

Martinez’s lawsuit says the process went awry during her 2018 spinal fusion in Houston, an operation in which an implant is inserted into the spinal column to replace a worn or damaged disc.

Martinez was under anesthesia, with her spine destabilized, when Rahman discovered the Life Spine surgical kit did not contain any implants shorter than 50 millimeters, or about 2 inches. That was too large, according to the complaint. Martinez, a former day care worker, blames her injuries on the redo operation, which replaced the implant with a 40 mm version Life Spine supplied later.

Through his lawyer, Rahman declined to comment. In court filings, the surgeon has denied responsibility. His operating notes, according to court pleadings, say he had ordered “all lengths available” of the implant through a Life Spine distributor and its sales reps. In a June court filing, Rahman contends the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery … and was not the result of any alleged negligence.”

In the court filing, Rahman also argues it was “appropriate” for him to rely on the sales reps and hospital staff to “inform him as to whether all materials and equipment needed for surgery were available.”

Illinois-based Life Spine also denies blame. In court filings, it says the sales reps initially ordered a sterile kit that included only implants from 50 mm to 55 mm long, which it duly shipped to Houston.

At the time of Martinez’s operation, Life Spine was the target of a sealed whistleblower lawsuit accusing it of paying improper consulting fees and other kickbacks to more than 60 surgeons who agreed to use its wares. Court records in the whistleblower case identify Rahman as one of the company’s paid consultants, although he and the other surgeons were not named as defendants.

Life Spine and two of its executives settled the matter in 2019 by paying a total of nearly $6 million. An orthopedic surgery expert hired by Martinez for her suit faulted Rahman for not making sure he had the right gear “prior to the start of surgery,” according to his report. The expert also criticized the sales rep for failing to bring “all available lengths to the procedure or to inform Dr. Rahman that the necessary implants were not available,” court records show. The sales rep and distributor denied any blame, arguing in court filings that they “met all applicable standards of care.”

Frenzied Competition for Sales

Major device makers train a corps of sales agents, some recruited right out of college, to cultivate and work closely with surgeons — one likened the relationship to a caddy and an avid golfer. Duties can include lugging 20-pound sets of surgical hardware to the operating room, assuring it is sterile and knowing its specifications, though the reps are not required to have medical training or credentials.

Stryker, one of the nation’s top four spine implant manufacturers, spends what it calls “a significant amount of time and money” to train reps. When hired, they typically “shadow” other reps for three to six months, then attend a 10-day intensive “Spine School” and other training. In all, the company said in a court filing, it typically takes eight to 18 months, often longer, to develop “long-term relationships” with customers.

For those who do, the jobs can pay handsomely. Veteran reps who influence which brands of hardware surgeons select command salaries and bonuses that can stretch into the low six figures and beyond, court records show.

The market is so hotly competitive that device makers typically require reps to sign contracts that prohibit them from working for a rival company in the same territory for a year or more — and aren’t shy about suing to fend off raids on their staffs, court records show.

In 2019, DePuy Synthes sued an Alabama sales rep who jumped ship, blaming him for stealing away accounts “worth millions of dollars practically overnight.” An arm of health care giant Johnson & Johnson, DePuy Synthes filed at least two dozen similar suits from 2014 through the end of 2020, court records show. Most, including the case of the Alabama sales rep, have been settled under confidential terms.

Some companies have spent lavishly to poach experienced sales agents — practices that can violate business conduct laws. One allegedly paid a New York sales pro a “staggering, seven-figure signing bonus.” Another is said to have dangled an $800,000-a-year job as “director of surgeon education,” while a gambit to make inroads in the Phoenix market dubbed “Sun Devil” guaranteed a branch manager a $500,000 annual salary, court records show. Another promised a sales agent $900,000 paid out over three years.

Whistleblowers and government investigators have argued for years that so much money changing hands can lead to kickbacks or other marketing schemes that corrupt medical judgment and endanger patients. Some injury suits also have blamed sales reps and distributors for staying mum about product deficiencies they observed in the operating room. These cases often are settled with no admission of wrongdoing.

Sometimes, surgeons help promote implants at medical meetings and other gatherings. Orthopedic surgeons and neurosurgeons received a total of about $511 million in industry consulting fees from 2013 through 2019 and nearly $300 million more for “serving as faculty or speaker” at industry-sponsored events, a KHN analysis of government data found.

Dozens of lawsuits have taken aim at Indiana device maker Biomet’s advertising a hip replacement for “younger, more active patients” that showcased Olympic gold medal gymnast Mary Lou Retton. One ad says “Mary Lou lives pain-free, and so should you.” Yet Retton suffered painful heavy-metal poisoning requiring the implant’s removal and sued the company for damages, according to court records. Retton said she and Biomet settled the suit in 2019 under confidential terms.

Defects Ignored or Downplayed

Whether touted by renowned surgeons or celebrities, orthopedic surgery marketing materials stress quick improvement in a person’s quality of life. That proves true for most patients. Yet researching how often implants fail or cause life-changing injuries — and which brands have the best safety records — can be daunting.

The FDA requires device makers to advise the agency of information “that reasonably suggests” a device they sell “may have caused or contributed to a death or serious injury or has malfunctioned” in a way that could recur. The FDA posts the reports on a public website, with the caveat that they may convey “incomplete, inaccurate, untimely, unverified, or biased data.”

KHN found that thousands of malpractice and product liability lawsuits have accused device marketers of concealing or downplaying hardware defects, leaving patients and their doctors in the dark about possible risks. In many cases, these claims are bolstered by company records, or actions by state or federal regulators.

In 2019, for instance, DePuy Synthes paid $120 million to settle a lawsuit filed by 46 state attorneys general; the suit accused the company of advertising that a replacement hip it sold lasted three years in 99.2% of operations, when it knew of data showing that 7% had failed within that time. The company did not admit wrongdoing in settling the case.

British device company Smith & Nephew faces a federal civil proceeding comprising nearly 1,000 injury suits, including one that says the company “underreported and withheld” notices of malfunctions and “willfully ignored the existence of numerous complaints about [its] failures.”

An expert hired by the patients cites a company audit showing “significant adverse events” were logged from two days to 142 days late, while a corporate memo circulated among executives to push sales was titled “Milk the Cash Cow,” according to court records. Smith & Nephew has denied the allegations and in one court paper called the expert’s opinions “speculative.”

John Saltis is suing spinal device company NuVasive over its handling of his complaint that a screw holding his spinal implant in place snapped in May 2016, about 17 months after his operation.

Saltis, 68, was two hours into his workday as a toolmaker at General Electric in Rutland, Vermont, when he felt sharp pain in his neck and shoulder, bad enough to send him to the hospital emergency room. X-rays revealed the screw had broken and, according to Saltis, fractured vertebrae in the process.

Saltis said the San Diego-based device company told the FDA the incident caused no harm. But Saltis said he has lingering numbness and pain in his right hand. As a result, he said, his lifestyle has “changed dramatically.”

“I miss things like bowling and playing toss with my grandkids,” he said.

Hans Pennink for KHN

In 2019, Saltis sued NuVasive without a lawyer, hoping to show the $600 screw was defective. In a court filing, NuVasive said Saltis is arguing “the screw is defective because it broke.” That’s not good enough, according to NuVasive, which argues that Saltis must show the screw was “unreasonably dangerous” to press his claim. In late June, a federal judge agreed and dismissed the suit, though she allowed Saltis to amend his complaint, which he is pursuing. The case is pending.

A Push for Change as Pandemic Eases

As hospitals resume elective operations stalled by the coronavirus, some industry critics see an opportunity to rethink orthopedic surgery practices — from sales to tracking of injuries.

Some want to keep industry reps out of operating rooms and place tighter restrictions on their access to hospitals. They say the current system needlessly drives up health care costs and exposes patients to risks such as infection from extra people in the operating room.

Sales reps say their technical knowledge and skills make operations safer for patients and note that many surgeons enjoy the security of having them present in the operating room. Reps also say they perform tasks that hospitals would need to hire additional personnel to do, such as keeping track of device inventories.

“The industry has embedded reps into the supply chain, and it is a hard culture to break,” said Itai Nemovicher, president of the Orthopaedic Implant Co., which seeks to produce lower-cost implants.

Yet guidelines for “reentry” after covid put out by AdvaMed and the American Hospital Association say medical device reps should deliver “services, information and support remotely whenever possible.” The guidelines advise hospitals to use videoconferencing gear when it “does not compromise patient safety or privacy.”

Dr. Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University, said device reps are viewed as part of the operating room team even though they are there to sell products.

“That is pretty horrifying from a patient’s point of view,” said Fugh-Berman. “Relying on sales reps in the OR is appalling. We need to come up with a better system.”

Greater transparency might have helped Little Rock, Arkansas, resident Christopher Paul Bills. He sued Consensus Orthopedics, the maker of a hip implant system that he alleged failed and sent metal through his hip joint that his surgeon said in 2016 looked “as if a bomb had gone off.” An Australian registry that tracks outcomes of operations identified the implant as having a “higher number” of hip failures compared with other manufacturers, according to the suit.

Bills underwent four operations and spent more than a year in the hospital and in rehabilitation, costs borne by Medicare and private insurance.

“Mr. Bills was left with no right hip at all and his surgeon does not plan to install a replacement hip,” the suit says. Bills uses an electric scooter to get around and hopes to graduate to hand-held crutches. “Since his right leg is useless, he will require a vehicle with hand-controls to drive,” according to the suit. The company disputed Bills’ claims and denied its hip system had any defects.

The case ended in 2019 when Bills died of cancer unrelated to his operations, said his lawyer, Joseph Saunders. “He never did get justice,” Saunders said.

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

Who Gets Rx Opioids and Who Doesn't

By Pat Anson, PNN Editor

Although opioid prescriptions in the U.S. have fallen by 40% since 2011 and now stand at their lowest level in 20 years, it’s still common to see claims that opioids are “overprescribed.”  

“Doctors And Dentists Still Flooding U.S. With Opioid Prescriptions” was the headline used by National Public Radio for an in-depth look at opioid prescribing practices.

“Public data, including new government studies and reports in medical literature, shows enough prescriptions are being written each year for half of all Americans to have one,” NPR reported in 2020. “Patients still receive more than twice the volume of opioids considered normal.”

A new study by the CDC gives some much-needed context to the myth that opioid prescriptions are flooding America. Over the past decade, the so-called flood has turned into a trickle for the vast majority of chronic pain patients – the people most in need of effective analgesia.  

The CDC study, which is based on the 2019 National Health Survey, found that only about one in five chronic pain patients – 22.1 percent – had used a prescription opioid in the past 3 months. In other words, it is “normal” for pain patients not to get opioids. 

A previous study that looked at opioid prescriptions in 2010 found that 36.4 percent of patients with chronic non-cancer pain were prescribed an opioid.  While there are differences in methodology between the two studies, the data seems to confirm that there has been a shift in prescribing practices over the past decade. Pain patients are significantly less likely to get an opioid prescription today than they were in 2010.

The new CDC study is also the first to take a deep dive into the demographic and socioeconomic characteristics of opioid recipients -- how age, sex, insurance, income, education and other factors make patients more or less likely to take opioid medication. Considering how much attention has been paid to opioid prescribing over the last decade, it’s surprising no one has looked into this before.

Researchers found that you are more likely to use prescription opioids if you are female, aged 45-64, unemployed, live in a rural area, and a Medicaid or Medicare beneficiary.  Being Black, White, a non-veteran, and living below the federal poverty level also makes you more likely to take a prescription opioid.

YOU ARE MORE LIKELY TO TAKE Rx OPIOIDS IF YOU ARE ...

SOURCE: CDC

Conversely, you are less likely to take prescription opioids if you are male, aged 18-29, employed, a military veteran, privately insured, and live in a household at least 200% above the federal poverty level. Being Hispanic, uninsured, having a college degree, and living in a large metropolitan area also makes you less likely to use opioid medication.   

YOU ARE LESS LIKELY TO TAKE Rx OPIOIDS IF YOU ARE ...

SOURCE: CDC

The CDC study did not look what type of chronic pain condition a patient had or how long they had it. It’s possible the condition itself led to someone becoming unemployed, disabled and poor, or that some other factor is at work. Military veterans, for example, have high rates of chronic pain but get fewer prescriptions because the Veterans Administration strongly discourages the use of opioids.

Researchers also relied on patient “self reports” and did not compare their answers with prescription records. Given the stigma association with opioids, it’s possible some patients may have answered “no” to opioid use, when in fact they used the drugs.

No study is without limitations, but this one shows some clear disparities between who uses opioid prescriptions and who does not. Poverty, lack of education and unemployment may have more to do with pain, drug use and “overprescribing” than policy makers and anti-opioid zealots have been willing to admit.