Nearly 80% of People Taking New Migraine Prevention Drugs Report Improvement

By Pat Anson, PNN Editor

Nearly 80% of people taking a new class of medication to prevent migraine say their migraine headaches are “better” since they started taking the drugs, according to a survey conducted by Eli Lilly.

Calcitonin gene-related peptide (CGRP) inhibitors prevent migraines by blocking a key protein released during migraine attacks from binding to nerve receptors in the brain. Since 2018, the FDA has approved three injectable CGRP inhibitors and one oral CGRP medication for migraine prevention. Eli Lilly makes Emgality (galcanezumab), one of the monthly self-injected drugs.

Nearly 600 migraine patients who use CGRP inhibitors participated in the survey, which is part of Lilly’s OVERCOME study, a large web-based survey of migraine sufferers.

While 79.2% said their migraine was better, nearly 10% said it was worse and about 11% said there was no change. The findings were relatively consistent between patients who suffer a handful of migraines each month and those who have them more frequently.

"It is very encouraging that nearly 4 out of 5 people in the survey taking a CGRP monoclonal antibody felt better and reported their migraine had improved," Sait Ashina, MD, a neurologist and scientific advisor to the OVERCOME study, said in a statement.

"It is also notable that the OVERCOME survey reported the clinically meaningful distinction between individuals who reported no change in their migraine with those who said their migraine worsened. This distinction can enhance conversations between the healthcare provider and the patient regarding treatment expectations when considering the use of these novel migraine preventive medications."

Nearly two-thirds (62.6%) of those who used a CGRP inhibitor said they also took another migraine prevention drug, such as topiramate and duloxetine. Use of an additional medication was generally higher among patients who reported frequent migraines.

Lilly presented the survey results this week at the 18th Migraine Trust International Symposium.

The findings are similar to those in a 2019 survey of migraine patients conducted by Health Union. Over half of those using CGRP inhibitors said the benefits of taking the drugs outweighed their side effects. About 9 percent said the medications were not worth the side effects, which include constipation, fatigue and weight gain.

The Health Union survey also found that patients who were not satisfied with a CGRP medication wasted little time switching to a new brand. Most of those who switched said the drugs did not work or stopped working after an initial period of efficacy. 

Patient Advocate Who Drew Attention to Pharmacy Discrimination Dies

By Pat Anson, PNN Editor

A patient advocate in California who fought breast cancer and helped draw attention to the discrimination often faced by pain patients at pharmacies has died. April Doyle passed away last month after a 12-year battle with metastatic breast cancer. She was only 42-years old.    

In April 2019, Doyle posted a tearful video on Facebook and Twitter after a Rite Aid pharmacist refused to fill her prescription for Norco, an opioid medication she took for cancer pain. At the time, her Stage 4 breast cancer had metastasized into her lungs, spine and hip. 

“I have to take 20 pills a day just to stay alive,” Doyle said in the video, which soon went viral. “Every time I take my pain pill prescription there, they give me the runaround. They don’t have enough in stock or they need me to come back tomorrow because they can’t fill it today. Or something stupid. It’s always something and it’s always some stupid excuse.”

Doyle’s video struck a chord with pain patients around the country, who often have trouble getting their opioid prescriptions filled. The publicity also led to apologies from a Rite Aid vice-president, the store manager and the pharmacist who refused to fill her prescription.

Doyle said the pharmacist told her he was worried about being fined or even losing his job if he filled her prescription, even though cancer pain is exempt from opioid prescribing guidelines. 

“It’s astonishing the reaction it has gotten. I had no idea this was so common. It’s actually kind of sad how common it is,” Doyle told PNN at the time. “It really struck a nerve with what’s apparently a big problem.”

Doyle wrote several articles about breast cancer that were posted online and her own blog. In her final post on AdvancedBreastCancer.net, Doyle shared her feelings and worries about her young son while she was sick at home from chemotherapy.

“He’s such an amazing boy and it isn’t fair that he has to grow up with a sick mother. If I’m even around for much more of his growing up. In my heart, I know this is what I’m really mourning,” she wrote.

“Cancer is slowly taking things away from me. I hate, hate, that I can’t do something myself. The stubbornness in me is resisting yet it comes out a waterfall of tears. Something so mediocre or dumb to someone else, but it’s an example of what my life has become and how I no longer can dictate what I can or cannot do.”

“April was a dedicated advocate in the metastatic breast cancer community. She told her story with authenticity and inspired so many young women and men living with the disease. She had a way of bringing people together and supporting people in all stages of breast cancer,” Doyle’s obituary in the Visalia Times said.

“She never let her disease define her. She never backed down from adversity and always stood forefront. April fought the stigma and stood up for patient rights. She leaves a legacy in the breast cancer community that will inspire people forever.”

Doyle leaves behind her 9-year old son, Colin. Her family asks that donations in her honor be made to METAvivor, a non-profit that supports breast cancer research.

Study Finds Cannabis Does Not Reduce Opioid Abuse

By Pat Anson, PNN Editor

It’s a common belief that cannabis may reduce the use of opioids and may even help solve the opioid crisis. But a new study by researchers at Columbia University Mailman School of Public Health found that people with substance abuse problems are just as likely to use heroin or to misuse prescription opioids on days when they consume cannabis.

The study, published in the journal Addiction, is believed to be one the first to test whether adults with substance abuse problems are substituting opioids with cannabis. Researchers followed 211 adults in the New York City area for 90 days, asking if they had used cannabis, heroin, or misused prescription opioids.

Participants were mostly male, unemployed, unmarried, and had a high prevalence of substance misuse and pain. “Misuse” of prescription opioids was defined as taking more pain medication than prescribed or without a prescription.

On average, participants reported they used cannabis on 15% of days without opioids, opioids were used on 15% of days without cannabis, and both cannabis and opioids were used on 7% of days. On days that participants used cannabis, the odds of using opioids nearly doubled. The findings were consistent whether participants were experiencing pain or not.

"Our results suggest that cannabis seldom serves as a substitute for non-medical opioids among opioid-using adults, even among those who report experiencing moderate or more severe pain," said Deborah Hasin, PhD, professor of epidemiology at Columbia Mailman School. "In other words, our study suggests that cannabis is not an effective way to limit non-medical opioid use."

Cannabis Users Need More Anesthesia

Another recent study found that cannabis may actually raise pain levels for patients recovering from surgery. In an analysis of 118 patients who had surgery for a broken leg at a Colorado hospital, researchers found that cannabis users needed more anesthesia during surgery than non-users. They were also more likely to have post-operative pain and use higher doses of opioid pain medication while hospitalized.

The findings, presented at the annual meeting of the American Society of Anesthesiologists, adds to the growing body of research suggesting that patients who use cannabis have higher anesthesia needs and more surgery-related pain.

"There is some evidence that cannabis may be beneficial for chronic and nerve pain. However, early research suggests that this is not the case for acute pain such as for surgery of a broken leg," said lead author Ian Holmen, MD, an anesthesiology resident at the University of Colorado Hospital in Aurora, where the study was conducted.

"We now understand patients who chronically use opioids prior to surgery often have exaggerated pain responses and need increased pain medication after surgery because they have an increased tolerance. We speculate that cannabis use may cause a similar effect, but we need more research to determine if this is the case."

Holmen and his colleagues found that cannabis users had higher pain scores while recovering from surgery and received 58% more opioids per day while hospitalized. They also needed about a third more anesthesia. The amount of anesthesia during surgery is typically based on observations of a patient’s involuntary body movements, increased heart rate, high blood pressure or increased rate of breathing, which are signs the patient may be experiencing more pain.

Researchers did not include in the study patients who suffered from chronic pain or those who had previously been prescribed opioids.

"This study shows that it is important for patients to tell their physician anesthesiologist if they have used cannabis products prior to surgery to ensure they receive the best anesthesia and pain control possible, including the use of non-opioid alternatives," said Holmen. "It also confirms that more research is needed to understand how cannabis impacts pain."

A 2019 study of patients who had colonoscopies found that regular marijuana users required three times the amount of a common sedative, propofol, as did nonusers.

How to Rekindle Romance While Living with Chronic Illness

By Barby Ingle, PNN Columnist  

Living with chronic illness can put a strain on any relationship, particularly marriages. To help other couples, my husband Ken and I have I decided to share our learned wisdom on how to rekindle romance in a chronically ill partnership.   

My first suggestion is to keep track in your pain diary so that you can remember the details. Record at what point during sexual intimacy that pain occurred or increased, and what the circumstances were when your pain subsided. Putting your thoughts on paper can help you understand the underlying issues and complications, and regain control of your intimacy.

Although Ken and I did not use a therapist, there are techniques that a therapist will suggest that can help a chronically ill person normalize their symptoms, which boosts self-esteem and lowers feelings of isolation. Improved self-esteem can enhance virtually every aspect of your life, including strengthening your relationships.

A life change due to health problems can be a common trigger for lowering how you perceive yourself. The challenge is to identify that this is going on and create an intimate connection with your partner at the same time.  

Take a look at what you are doing. Are you alienating yourself or your partner? If so, why? Think about your behaviors and beliefs. Are they holding you back from intimacy?

Consciously thinking positive thoughts can boost self-esteem, but it takes practice. How you approach it can make all of the difference. Start with simple words and reminders to yourself. Then reconnecting with your partner will become easier. 

Rekindling romance could be as simple as a few words, a gesture, or a look or touch that will let the other person know you are okay. Be conscious of this each day, so that not a day goes by without a kind word or gesture, even if you are not having sex daily. And really, who does that when they’re in constant pain?

Try this the next time you are washing your hands at the bathroom sink: Write “I love you” on the mirror with a soapy finger or lipstick. This can help create an intimate moment.  

Be the one to take control if your partner is afraid that they will hurt you further because of your current pain level. Be sure to reach out and let them know you would like to have a sexual experience. Say, “Do you want to have sex right now?” or whatever cute, sexy or clever way feels natural to you.  Lead the experience to relieve their worry.

Spouses often have different sexual desires. Turning your desire totally off just because of pain can cause harm to your relationship. Your partner probably married you expecting a healthy sexual relationship. Holding back on intimacy can lead to the end of a marriage or even infidelity.

The last thing a chronic pain patient needs is more discomfort. But when intimacy increases pain and leads to avoiding sex or even cuddling, the relationship suffers. Don’t let this be the beginning of a vicious cycle of no sex.  

What can you do to increase the connection, romance and sex that you have with your partner? When you are talking, try to share your struggles about staying close. You can also share positive thoughts, such as sex helping you cope with chronic pain. 

I hope that these tips can help you rekindle any lost sparks with your partner. All those things you don’t say could be keeping you and your partner on different pages. Turn on the power of romance and make your relationship stronger.

Believe me, I understand how difficult it can be to push yourself to be romantic when all you want to do is sleep or cry from the pain. Having a close relationship physically with your partner can make a huge difference in many areas of your life.

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

Most Patients Satisfied With Telehealth, But Some Exploited for Healthcare Fraud

By Pat Anson, PNN Editor

Telehealth has been a godsend for pain sufferers during the coronarvirus pandemic, with many patients discovering the ease and convenience of visiting with their doctors online or over the telephone. Some have even been able to get prescriptions written for opioid medication without an initial face-to-face meeting with their doctors – thanks to a DEA decision to relax some of the rules about prescribing controlled substances.  

Unfortunately, some providers are taking advantage of patients — and the pandemic — by filing billions of dollars in false medical claims.

Saving Time and Money

Most patients who use telehealth – also known as telemedicine – to connect with pain management specialists were highly satisfied with their experience, according to a new study presented at the annual meeting of the American Society of Anesthesiologists.

Last summer, researchers at UCLA’s Comprehensive Pain Center began giving patients the option of in-office visits or remote appointments via telehealth. Nearly 1,400 patients chose telehealth, resulting in nearly 3,000 virtual appointments before and during the pandemic, from August, 2019 to June, 2020.

“This era of contactless interactions and social distancing has really accelerated the adoption of telemedicine, but even before the pandemic, patient satisfaction was consistently high,” said lead author Laleh Jalilian, MD, an anesthesiologist at the Ronald Reagan UCLA Medical Center in Los Angeles.

“Patients who are being evaluated for new conditions may be better off having office visits initially. But once patients establish a relationship with providers, follow-up visits can occur efficiently with telemedicine, while maintaining patient rapport and quality outcomes. We believe 50 percent of our visits could be conducted via telemedicine.”

Asked about their experiences with telehealth, 92 percent of patients said they were satisfied. Many said they were happy to avoid the lengthy commutes and time spent in Los Angeles area traffic. On average, patients saved 69 minutes in traffic per visit and $22 in gas and parking fees.

For telehealth to be sustainable in a post-pandemic world, Jalilian says insurers should consider expanding reimbursement for providers to take into account the additional work and technology needed for telehealth visits. The Centers for Medicare & Medicaid Services (CMS) has waived many of the limits on telehealth visits during the pandemic and some private insurers have followed suit.

“Now that telemedicine is more widespread, it may become a valued part of care delivery in chronic pain practices,” said Jalilian. “Clearly many patients benefitted from remote consultations and follow-up appointments using telemedicine. We hope it will encourage policymakers and insurance providers to continue to support these platforms and inspire more innovation in this developing field of research and patient care.”

Telehealth Fraud Takedown

But as demand has grown for telehealth services, federal prosecutors say hundreds of healthcare providers have exploited the situation. In what’s being called the largest healthcare fraud and enforcement action in Department of Justice history, criminal charges were recently filed against 345 doctors, nurses and other providers for submitting over $6 billion in false and fraudulent claims to Medicare, Medicaid and private insurers. Some of the false claims were for COVID-19 testing.

The fraud charges involve more than $4.5 billion connected to telemedicine, $845 million involving substance abuse treatment, and $806 million connected to illegal opioid distribution.

“This nationwide enforcement operation is historic in both its size and scope, alleging billions of dollars in healthcare fraud across the country,” said Acting Assistant Attorney General Brian Rabbitt.  “These cases hold accountable those medical professionals and others who have exploited health care benefit programs and patients for personal gain.” 

Prosecutors say telemedicine executives allegedly paid kickbacks to doctors and nurse practitioners to order unnecessary medical equipment, genetic and other diagnostic testing, and pain medications, either without any interaction with patients or after a brief telephone conversation with patients they had never met or seen. Medical equipment companies, genetic testing labs and pharmacies then purchased the orders in exchange for illegal kickbacks and bribes.

In addition to those charges, CMS announced that it had taken administrative action against 256 healthcare providers, revoking their Medicare billing privileges because of their involvement in telemedicine schemes. 

“Telemedicine can foster efficient, high-quality care when practiced appropriately and lawfully.  Unfortunately, bad actors attempt to abuse telemedicine services and leverage aggressive marketing techniques to mislead beneficiaries about their health care needs and bill the government for illegitimate services,” said HHS Deputy Inspector General Gary Cantrell. 

The charges against substance abuse treatment facilities -- known as “sober homes” – mostly involve illegal payments to patient recruiters for referring scores of patients to treatment facilities. The patients were then subjected to medically unnecessary drug testing – often billing thousands of dollars for a single test – and therapy sessions that were often not provided.

Some sober homes also allegedly prescribed medically unnecessary controlled substances and other medications to patients to entice them to stay at the facility.  Prosecutors say the patients were then often discharged and admitted to other treatment facilities, or referred to other labs and clinics, in exchange for more kickbacks.

Opioid Guidelines Leave Some Surgery Patients in Pain

By Pat Anson, PNN Editor

In recent years, many U.S. hospitals have adopted policies that reduce or eliminate the use of opioids during and after surgery.

Patients at Houston Methodist Hospital, for example, are getting acetaminophen (Tylenol) for post-operative pain after hernia repairs and other minimally invasive surgeries. And dozens of hospitals in Michigan have adopted guidelines for post-operative pain that have significantly reduced the use of opioids.

But a new study presented at the annual meeting of the American College of Surgeons suggests that policies that discourage the use of opioids for post-operative pain may be neglecting patients that need opioids for better pain control.

“The key findings of our study are that we were able to successfully reduce how many opioids we were prescribing for patients after operations using evidence-based guidelines,” said lead author Cornelius Thiels, DO, a surgical oncology fellow at Memorial Sloan Kettering Cancer Center and a researcher at the Mayo Clinic.

“However, the other finding of our research is that there’s still additional room to improve in terms of making sure all patients after surgery have their pain well controlled.”

The researchers evaluated 138 patients who had one of 12 elective surgeries after the Mayo Clinic adopted guidelines in 2018 that call for “multimodal pain control,” a combination of opioids with non-opioid pain relievers such as ibuprofen, naproxen and acetaminophen. Those patients were compared with 603 patients who had the same procedures before the guidelines, when opioids were used more widely.

While most patients in the post-guideline group were satisfied with their pain control after discharge, a significant number were not.

In telephone surveys conducted about four weeks after discharge, the percentage of patients in the post-guideline group who were dissatisfied with their pain control was more than double that of the pre-guideline group (9.4% vs. 4.2%). The percentage who said they were not prescribed enough pain medication was also higher (12.5% vs. 4.9%).

“There is a small subset of patients who we’re not optimally managing yet, and this study confirmed that this is a small number,” Thiels said. “However, I think that’s a critically important subset of patients.”

Thiel says about half of patients need opioid medication after major surgeries, and doctors need to do a better job identifying who they are.

“Our goal is to give them the exact right amount so that we limit the number of un-used opioids in our community while also making sure we don’t reduce it down too far and then leave them in pain,” he said. “The right answer may be more non-opioid based pain medications, better patient education and setting of expectations, or in some cases patients may actually require slightly more opioid medications, and that is OK.”  

Opioid addiction is actually rare after surgery.  A large 2016 Canadian study found only 0.4% of older adults were still taking opioids a year after major elective surgery.  Another large study in the British Medical Journal found only 0.2% of patients who were prescribed opioids for post-surgical pain were later diagnosed with opioid dependence, abuse or had a non-fatal overdose.

President Trump Should Consider Stem Cell Therapy for His COVID-19

By A. Rahman Ford, PNN Columnist

President Trump remains hospitalized at Walter Reed Medical Center after being diagnosed with COVID-19 last week, along with First Lady Melania Trump. The president suffered from fever, congestion and fatigue, and received supplemental oxygen therapy before being admitted Friday.

Details about his current condition and treatment are scant, but Trump has reportedly received an experimental antibody drug and started a course of the antiviral drug remdesivir. In a video posted on Twitter Saturday night, the president said he was “starting to feel good” but the next few days would be “the real test.”

With few effective treatments available for coronavirus, the president and his doctors should seriously consider stem cell therapy, which is being investigated in dozens of clinical trials as a treatment for coronavirus. Other experimental therapies like hydroxychloroquine, remdesivir and blood plasma are not effective for all patients.

Coincidentally, President Trump has long been an advocate for stem cell therapy. In his 2017 State of the Union Address, he acknowledged the medical plight of a woman who was forced to travel to Mexico to use her own stem cells to treat her systemic idiopathic juvenile arthritis. Trump said seriously ill patients “should have access to experimental treatments” without traveling overseas and urged Congress to pass the Right to Try Act so that Americans can get help “right here at home.”

Stem cell therapy may be the safest and most effective treatment for the most life-threatening symptom of COVID-19, acute respiratory distress syndrome (ARDS), an inflammatory “cytokine storm” in the lungs that makes breathing difficult. The conventional intervention for ARDS – mechanical ventilation – is invasive, overused and can increase the likelihood of bacterial infections.

Stem cells have intrinsic immune supporting properties that can ease the deleterious effects of ARDS. They could also potentially heal any tissue damage that ARDS may cause to lungs.

Research Supports Stem Cells for COVID-19

Even if President Trump’s symptoms are mild, the prophylactic use of stem cells to prevent disease spread is worthy of investigation. Celltex Therapeutics is currently conducting a Phase 2 multi-center, double-blind, randomized, placebo-controlled trial to evaluate the prophylactic effectiveness of autologous, adipose-derived mesenchymal stromal cells (MSC).

A recent review of the scientific literature on MSC therapy concluded that “Cellular based therapies hold great promise for the treatment of COVID-19.” Another study echoed that finding, saying “MSCs possess both regenerative and immunomodulatory properties, the latter of which can be harnessed to reduce the severity and longevity of ARDS in patients under intensive care due to SARS-CoV-2 infection.”

Researchers in China have called MSC therapy a “promising strategy” for COVID-19, but cautioned that “there is not enough clinical evidence to prove the effectiveness of MSCs in the treatment of ARDS.”  They called for large-scale, multicenter trials to further explore the safety and efficacy of MSCs.  

Other recent studies have concluded that stem cells “may possibly be one of the most ideal therapeutics” for COVID-19 and “might be considered for compassionate use in critically ill patients.”

FDA Approved Trials

Early in the pandemic, the FDA approved several clinical trials of stem cells for treating COVID-19. These trials are now at various stages of progress, ranging from investigational new drug (IND) applications, to active recruitment of patients, to late stage clinical studies. Trial sponsors include: VetStem, M.D. Anderson Cancer Center, Personalized Stem Cells, Hope Biosciences, Thomas Advanced Medical, Restem, University of Miami, Mesoblast, NantKwest, Baylor College of Medicine, Athersys, Masonic Cancer Center, Celltex and Pluristem Therapeutics.

More recently, Baylx had its IND application approved for umbilical cord-derived MSC cells and Stemedica Cell Technologies’ IND application for intravenous allogeneic MSCs. The FDA has even cleared Pluristem Therapeutics’ existing stem cell product for treating ARDS, allowing the company to treat up to 100 severely affected COVID-19 patients outside of a clinical trial.

There are also several ongoing international trials of stem cells, including studies in Jordan, United Arab Emirates, Pakistan, Mexico and Brazil.

President Trump and First Lady Melania owe it to themselves – and to us – to consider every possible treatment for COVID-19. The administration should also ensure that all Americans have access to stem cell therapy for COVID-19, by expediting clinical trials, expanding compassionate use, and granting emergency use authorization for advanced stem cell products, as was done for convalescent plasma. Ultimately, the president and FDA should relax restrictions on the use of our own stem cells for indications beyond COVID-19.

We all wish the President and First Lady a full and speedy recovery.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China. 

Pre-Existing Conditions Deserve Affordable Treatment

By Dr. Lynn Webster, PNN Columnist

The National Institutes of Health reports that about 10 percent of Americans experience a substance use disorder (SUD) at some point in their lives. Most of those who suffer from an SUD receive no treatment.

About twice as many Americans – 20 percent -- have chronic pain. Many of them also cannot find adequate treatment or even a provider willing to treat them. 

Making treatment accessible for both of these conditions -- which are defined as pre-existing for insurance purposes -- is always a topic of concern. These days, it is of paramount concern that access to treatment is available. And it requires us to take action.

We’re All at Risk for Pain and Drug Abuse

Poverty and hopelessness are risk factors for drug abuse, even though not everyone who is economically challenged develops an SUD. Unfortunately, prevention and treatment programs for SUDs are less available to those who cannot pay for them and who most need them.

Anyone can suffer from chronic pain, but even those with resources may not have access to adequate pain management.

My concern is more than theoretical. It is personal. I have friends, former patients and family members who suffer from SUDs. If the Affordable Care Act (ACA) — widely known as Obamacare — ends and we lose coverage of pre-existing conditions, I fear they will be abandoned in exactly the same way as people in pain have been abandoned ever since the CDC issued its 2016 opioid prescribing guideline.

In recent years, I have received hundreds of emails and calls from people in pain. Their medications have been tapered and they don't know where to turn for help. Untreated chronic pain, as well as untreated SUDs, can result in ruinous consequences: disability, destitution, isolation, poverty and suicide.

We need to help healthcare providers find more effective ways to treat their patients. The Centers of Excellence in Pain Education (CoEPEs) program was created to teach healthcare professionals about pain and its treatment. Since this is something most doctors do not study adequately during medical school, it's important to have continuing medical education opportunities to learn about the stigma associated with pain treatment and substance abuse disorders.

Abolishing ACA Could Have Devastating Consequences

The current administration has appealed to the Supreme Court to abolish the ACA. President Trump has said that Obamacare "must fall." Given the fact that we're in the middle of a pandemic and millions of people are unemployed and may have lost access to employer-sponsored healthcare, the timing seems terrible.  

But even without a pandemic, reversing the ACA would be devastating for millions of Americans who have an SUD or chronic pain. President Trump signed an executive order on September 24 that claims to protect people with pre-existing conditions. However, experts dispute whether his executive order can actually do what it promises.

Regardless, eliminating the ACA will likely allow insurance companies to charge higher rates for people with pre-existing conditions. This would essentially render treatment for chronic pain and SUD unaffordable for many people, leading to an increase of the terrible consequences mentioned above. And, of course, SUDs and chronic pain are only two of the pre-existing conditions that would no longer be protected. 

It is time for everyone to understand the consequences that losing the ACA may have for their community, family, friends and themselves. There is still time to be heard, but you have to act quickly. Click here to find your federal, state, and local elected officials and express your views.  

Let us also send healing thoughts and prayers to President Trump, the First Lady and everyone else infected with COVID-19.

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

COVID-19 Research Could Lead to New Painkillers

By Pat Anson, PNN Editor

A loss of taste or smell is one of the early signs of being infected with COVID-19. Scientists say the virus appears to bind itself to nerves in the nasal cavity, causing inflammation that blocks sensory signals associated with smell and taste from reaching the brain.

Researchers at the University of Arizona believe SARS-CoV-2 may have a similar effect on pain signals and essentially acting as an analgesic. That may explain why nearly half the people infected with COVID-19 experience few or no symptoms, even though they are still able to spread the disease.

"It made a lot of sense to me that perhaps the reason for the unrelenting spread of COVID-19 is that in the early stages, you're walking around all fine as if nothing is wrong because your pain has been suppressed," says Rajesh Khanna, PhD, a pharmacology professor at UArizona Health Sciences College of Medicine Tucson.

"You have the virus, but you don't feel bad because your pain is gone. If we can prove that this pain relief is what is causing COVID-19 to spread further, that's of enormous value."

Viruses cause infections by attaching themselves to protein receptors on cell membranes. Early in the pandemic, scientists established that SARS-CoV-2 enters the body via the ACE2 protein on the surface of many cells. Recent preliminary studies suggest there is another route to infection, in which the virus attaches itself to a receptor called neuropilin-1.

"That caught our eye because for the last 15 years my lab has been studying a complex of proteins and pathways that relate to pain processing that are downstream of neuropilin," said Khanna. "So we stepped back and realized this could mean that maybe the spike protein is involved in some sort of pain processing."

How COVID-19 Blocks Pain Signals

Many biological pathways send pain signals to the brain. One is through a protein called vascular endothelial growth factor-A (VEGF-A), which plays an essential role in blood vessel growth but also has been linked to inflammatory diseases such as rheumatoid arthritis and osteoarthritis. VEGF-A binds to neuropilin in a way that triggers a cascade of pain signals.

In research on rodents, Khanna says his team found that the SARS-CoV-2 binds to neuropilin in exactly the same location as VEGF-A, which “completely reversed the VEGF-induced pain signaling." The virus had an analgesic effect at both high and low doses.

Khanna and his colleagues’ groundbreaking research has been published in the journal PAIN. He also authored a blog post in the Daily Beast to explain the findings in layman’s terms. He says the discovery could not only lead to new treatments for COVID-19, but new ways to block pain signals.

“Sneaky virus, fooling people into believing that they do not have COVID-19. But, ironically, it may be gifting us with the knowledge of a new protein, critical for pain. Two roads emerge in the forest ahead: (1) block neuropilin-1 to limit SARS-CoV-2 entry, and (2) block neuropilin-1 to block pain,” Khanna wrote in the Daily Beast.

In future studies, Khanna say his research team will be examining neuropilin as a new target for non-opioid pain relief. They have already tested existing neuropilin inhibitors developed to suppress tumor growth in cancers and found they provided the same pain relief as SARS-CoV-2 when it binds to neuropilin.

"We are moving forward with designing small molecules against neuropilin, particularly natural compounds, that could be important for pain relief," Khanna said. "We have a pandemic, and we have an opioid epidemic. They're colliding. Our findings have massive implications for both. SARS-CoV-2 is teaching us about viral spread, but COVID-19 has us also looking at neuropilin as a new non-opioid method to fight the opioid epidemic."

A Different Perspective on Disbelief

By Carol Levy, PNN Columnist

I was watching a 2009 episode of Law and Order. The plot line revolved around a fetus who had Ehlers-Danlos syndrome (EDS). They talked about the trials the fetus would face if born, because he would have “fragile” skin that could tear at the slightest touch.

Never once was chronic pain, a major aspect of the disorder, even mentioned. I wondered why they ignored such an essential part of living with EDS. Could it be that the idea of chronic pain is foreign to most people, including scriptwriters? Not a novel thought by any means, but then I took the idea further.

Most of us know what a sprained ankle, aching tooth or thumb hit with a hammer feels like. It hurts like heck, but we know it will go away. We do as much as we can to make it stop as quickly as possible. Pain is something our bodies and minds abhor. And rightfully so.

For most people, acute pain is short lived. It does not disable us, at least not for more than a few hours or days. It is not debilitating. It does not take over our lives.

But for some of us, the pain lingers and becomes chronic. It changes our lives irretrievably. Our experience is antithetical to what most people know and how they experience pain. We still expect them to understand, but way too often they don't. And it is upsetting, even maddening, when they don’t.

But maybe it is not merely that they don’t “get it.” Our minds and bodies are created in such a way that we are meant to turn away from pain. Maybe that also means to turn away from the horrible idea that there can be pain that does not heal and does not go away.

It is easy to think – and hope -- that if I explain my chronic pain to those who deny it, who call me a hypochondriac or malingerer, that they will ultimately come around and understand.

Not understanding, or being unwilling to understand, always seemed to me as a failing in the other person; a lack of empathy or compassion. But maybe it is more than that. Maybe it is a biological and psychological imperative. To accept that pain can be chronic is anathema to the way our minds and bodies are programmed to respond to pain.

Not an excuse, but maybe a way to understand when someone says, “I don’t believe you.”

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.”



Cannabis-Based Drugs Risky for Older Patients with COPD

By Pat Anson, PNN Editor

While many senior citizens are discovering the benefits of medical cannabis in relieving pain and other health problems, a large new study suggests caution is warranted for those with chronic obstructive pulmonary disease (COPD).

Researchers at St. Michael's Hospital in Toronto say older adults with COPD who take prescription drugs made with synthetic cannabinoids were 64% more likely to die. The odds are even worse for elderly patients with COPD who take high-dose cannabinoids for the first time. New users had a 178% higher risk of being hospitalized for COPD or pneumonia and a 231% increased risk of death.

"Cannabinoid drugs are being increasingly used by older adults with COPD, so it is important for patients and physicians to have a clear understanding of the side-effect profile of these drugs," says lead author Nicholas Vozoris, MD, a respiratory specialist at St. Michael's and assistant professor at the University of Toronto.

"Our study results do not mean that cannabinoid drugs should be never used among older adults with COPD. Rather, our findings should be incorporated by patients and physicians into prescribing decision-making. Our results also highlight the importance of favouring lower over higher cannabinoid doses, when these drugs actually do need to be used."

The study analyzed the health data of over 4,000 older adults diagnosed with COPD who took either nabilone or dronabinol, two medications made with synthetic cannabinoids that are used to treat nausea, vomiting and loss of appetite.

The findings, published in the journal Thorax, suggest that nabilone and dronabinol may cause sedation and suppress breathing in patients whose health is already compromised by COPD, a progressive lung disease that causes difficulty breathing and chronic coughing.

"Older adults with COPD represent a group that would likely be more susceptible to cannabinoid-related respiratory side-effects, since older adults less efficiently break down drugs and hence, drug effects can linger in the body for longer,” said Vozoris.

“Cannabinoids may not be any safer to use among older adults with COPD than opioids, which are also associated with a heightened risk of respiratory- related morbidity and mortality. While further research is needed to confirm the safety profile of cannabinoid drugs among older adults with COPD, our findings should be taken into consideration in prescribing decision making in this population.”

Cannabis and Menopause

While high doses of cannabinoids may not be appropriate for older patients with COPD, many middle-aged women are using cannabis to treat symptoms of menopause.

According to a small study being presented at the annual meeting of The North American Menopause Society, over one in four women have either used or are currently using cannabis to manage menopause symptoms.

The study involved 232 female military veterans (average age of 56) living in Northern California. Over half reported hot flashes and night sweats regularly. Twenty-seven percent said they had used marijuana to help battle menopause symptoms, while another 10% said they were interested in trying cannabis.

“While the therapeutic use of cannabis by veterans is not altogether uncommon, this study is among the first to highlight veterans’ use of marijuana for this particular condition. Given cannabis’ relatively high rate of use among the women in this cohort, scientists and others would be well-advised to further explore its safety, efficacy, and prevalence among women experiencing menopause,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

A 2018 survey of over 2,700 elderly patients in Israel found that medical marijuana significantly reduced their chronic pain without adverse effects. Nearly one in five patients stopped using opioid medication or reduced their dose.

Lesbian, Gay and Bisexual Americans More Likely to Have Migraines

By Pat Anson, PNN Editor

A groundbreaking survey has found that lesbian, gay and bisexual (LGB) Americans are significantly more likely than straight people to suffer from migraines, according to a research letter published online in JAMA Neurology.

Researchers at University of California-San Francisco surveyed a nationally representative sample of nearly 10,000 adults aged 31 to 42, asking about their sexual orientation and whether they experienced migraine headaches.  

Nearly one third — 30.7 percent — of those who identified as lesbian, gay or bisexual reported having migraines, compared to 19.4 percent of those who said they were exclusively heterosexual.

Interestingly, participants who said they were mostly heterosexual but somewhat attracted to people of the same sex had nearly the same likelihood of migraine (30.3%) as those who identified as lesbian, gay or bisexual.

The researchers did not identify why LGB Americans are more likely to have migraines, but one possibility is the stress of living in families or communities that are not always tolerant of sexual minorities.

“Many members of sexual minority groups experience prejudice, stigma, and discrimination termed sexual minority stress, which could trigger or exacerbate migraine. Furthermore, members of sexual minority groups may encounter barriers to health care and experience greater physical and mental health problems, which could contribute to migraine,” wrote lead author Jason Nagata, MD, an assistant professor of pediatrics at UCSF.

“It is notable that even people identifying as mostly heterosexual had higher odds of migraine compared with those who identified as exclusively heterosexual, in accordance with other physical health disparities noted among nonexclusively heterosexual populations.”

The research is believed to be the first national study to show disparities in migraine based on sexual orientation. Previous studies found a high prevalence of migraine in sexual minorities in California and higher rates of health problems among LGBs who experienced prejudice.    

Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

COVID-19 Lockdown Made Symptoms Worse for Pain Patients

By Pat Anson, PNN Editor

A new survey is providing some insight into how patients suffering from arthritis, fibromyalgia and other types of joint and muscle pain fared during the early stages of the coronavirus pandemic.

In late April, researchers at the University of East Anglia (UEA) surveyed 678 patients in the UK with musculoskeletal pain, asking how the pandemic impacted their well-being and access to healthcare. The online survey was conducted five weeks after the start of a nationwide lockdown in which at-risk patients were told to “shield” at home, avoid all social contact, and postpone or cancel non-urgent healthcare appointments.  

"When lockdown happened, we were worried that this may become a much greater problem - particularly for those with bone, joint and muscle pain,” said co-author Toby Smith, PhD, a professor at UEA's School of Health Sciences. “We wanted to know how the new restrictions might affect pain, and better understand who is most at risk of experiencing flare-ups, or reduced well-being due to social isolation and loneliness.

"Our results show that the coronavirus pandemic is a major challenge to people's health and well-being, both to young and older people.”

Over half the patients (53%) reported that their musculoskeletal symptoms had worsened since the start of lockdown. About a third said they had seen a general practitioner or hospital rheumatologist because their pain, stiffness and overall health had significantly worsened. Those who reported greater social isolation and loneliness were less likely to access healthcare.

The vast majority of respondents, over 88 percent, reported little difficulty getting medication during the lockdown, but nearly half (44%) needed the assistance of others to do it.

"Should further isolation measures need to be enforced as we have seen in some part of the UK as the pandemic continues, particular efforts should be made to protect and support the socially isolated as a vulnerable group,” said co-author Alex MacGregor, PhD, a professor at UEA's Norwich Medical School. "Healthcare providers should reach out to individual patients who do not come forward for advice, and who might be silently struggling with their disease.”

Due to a recent surge in coronavirus infections, British Prime Minister Boris Johnson recently tightened nationwide restrictions, ordering bars and restaurants to close by 10pm. More people are also being required to wear masks. Asked about reports the government was planning a “total social lockdown” in northern England and London, Johnson’s health minister told the BBC she wouldn’t rule it out.

The UK survey findings, published in the journal Rheumatology: Advances in Practice, are similar to those found in a PNN survey of over 2,200 patients in April. About 70% said they were worried about going to a hospital or doctor’s office and had postponed or cancelled a medical appointment. A little over half said social isolation made them feel lonely.

6 Reasons to Participate in Clinical Trials

By Dr. Lynn Webster, PNN Columnist

The COVID-19 pandemic has left many people feeling helpless -- yet you can help defeat the virus. You may not be a medical researcher, but you can still be part of developing a vaccine. There are three COVID-19 late-phase vaccine trials currently underway in the United States, and they will involve more than 100,000 individuals. 

All stages of research  require volunteer subjects. Early-phase trials require healthy volunteers, who may not directly benefit from a vaccine or medication but participate for other reasons. The current COVID-19 vaccine trials, for example, involve people who do not have the infection. Some will receive the new vaccine and others will get a placebo.

Only after volunteers are exposed to the virus can scientists determine if the vaccine is safe and effective when compared to a placebo. If a participant becomes ill because of exposure during the trial, the sponsor of the study generally pays for their medical expenses.

Not all clinical trials involve a placebo, but most do. Later-phase trials may offer benefits to the volunteers who have the disease or condition that the drug targets.

There are various ways to get involved in a trial. You may be invited to join one of these trials. Your physician may be part of network of providers participating in a study. If so, they can offer you an opportunity for enrollment. Or, if you are looking for a specific treatment, you can go online to find a study that may be of interest to you.

Here are six reasons to consider participating in a clinical trial:

1) Clinical trials provide safer and more effective therapies

Without clinical trials, development of new and more effective treatments would not be possible. Medical advances depend upon people who are willing to participate in trials. Every drug, from vaccines to pain treatments, approved by the FDA has been studied in clinical trials.

2) Clinical trials provide you with free access to a new treatment

When I started to treat people in pain, I conducted clinical trials to provide my patients with cutting-edge technology that was not yet publicly available. I wanted my patients to have access to the best and newest therapies in the pipeline.

Of course, there was no guarantee that the experimental therapies would be effective. However, the treatments were free to participants in the trial. If the risks were perceived as acceptable, it could be worth it for patients to take the chance.

3) Clinical trials can save your life

Late-phase clinical trials, such as the three currently underway for COVID-19, may provide immunization that could save the life of the participant. Through other clinical trials, we have provided lifesaving therapies to subjects who otherwise could not have obtained them because they couldn’t afford the treatments, or the treatments simply were not available to consumers.

4) Clinical trials can save a loved one’s life

Clinical trials provide researchers with more knowledge and potential therapeutic options. Participating in vaccine trials can lead to the approval of a treatment. This could save the life of a family member who may one day need a vaccination or drug treatment.

5) Clinical trials are regulated by FDA

Clinical trials are highly regulated and generally regarded as safe. Most clinical trials sponsored by industry are required to have their protocols reviewed and accepted by the U.S. Food and Drug Administration, which assesses the safety of every trial. The agency will not allow a company to begin a trial that has not been fully vetted by several FDA departments.

In addition, all protocols must be submitted to an institutional review board (IRB) for approval. This is an independent body charged by the FDA to evaluate and monitor trials. The IRBs and principal investigators contract with the FDA to follow guidance from the Federal Office for Human Research Protections. Both IRBs and principal investigators can be criminally charged if they fail to adequately monitor and accurately report results of a trial.

When the FDA grants permission to fast-track a particular therapy because of an emergency situation, protocols may be loosened. The potential benefits, in that case, have been determined to outweigh the risks. We have to hope that the accelerated approval process for a COVID-19 vaccine will not cause adverse events.

Prior to enrolling in a trial, participants are provided with an informed consent form that describes the trial in layman's terms and explicitly states all of the potential risks. Participation in clinical trials is always voluntary, and a person can withdraw from a trial at any time.

6) Clinical trials may compensate participants

Some trials compensate participants for their time and travel. This occurs more often in early-phase trials for which there is no clear clinical benefit to the individuals. Most trials requiring participants to stay overnight in a research facility compensate volunteers. Participants' compensation depends on the amount of time the testing takes and the types of tests that are performed.

Compensation must be reasonable, yet not excessive. Compensation ranges from $50 or less for a simple saliva sample to $10,000 or more for studies that require staying in a facility for 30 days or so. 

You can learn more about clinical trials at the National Institutes of Health website or by visiting the Clinical Trials website. The National Institute of Allergy and Infectious Diseases also has a website to connect volunteers to coronavirus vaccine trials. And COVID Dash has a portal where people can volunteer for dozens of coronavirus studies around the world.

One clinical trial may create the breakthrough that helps us get the pandemic under control. But that can only happen if enough people from a variety of demographics are willing to volunteer to be a part of the effort.

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

My Undiagnosed ‘Growing Pains’ Nearly Killed Me

By Mikki Ingram, Guest Columnist

When I was a little girl growing up in Oklahoma, I was a tomboy. I played outside constantly no matter the season and was excited to be so close to nature. I did this in spite of frequent sprains, joint dislocations and abnormally bad “growing pains” starting at age three.

To me, those things were normal. I never thought to ask anyone about their own experiences, because my parents never made any fuss. Why should I?

As I grew up, the growing pains never stopped. I remember multiple times, as I was in the throes of puberty and even after, waking up in the middle of the night, crying and rubbing my joints. I had menstrual cramps so bad that I had to miss school. No Tylenol or ibuprofen combination would touch those pains. My dad thought I was being overly sensitive.

MIKKI INGRAM

After my daughter was born in 2003, I became extremely ill. The growing pains that I had come to regard as normal were more extreme than ever. Fatigue also swept over me. I missed the first 6 months of my daughter’s life because I was asleep for most of it.

The pain was consistent, the fatigue more so, and every doctor I went to said the same thing: “You look fine. You’re too young for this.”

I was diagnosed that year with fibromyalgia by a rheumatologist who called it a “diagnosis of convenience.” I was also advised to lose weight, eat better food and that the pain was all in my head. My primary care provider even said I should put my child up for adoption.

After months of plying me with random medications, none of which worked for this pain, I went to a hospital emergency room. The nurse that I saw is a woman I’ll never forget.

She ran an ultrasound on my gallbladder and came back saying, “You have gallstones. There are four of them and one of them is almost one and a half inches wide. You need your gallbladder out. Take these slides to your doctor and get a surgery scheduled.”

I was grateful beyond measure to her. My doctor, however, wasn’t. He didn’t see the need for urgency, so he scheduled my surgery for several months later. Meanwhile, the pain refused to stop. My fat-free diet did nothing and I was in trouble. In the ER of that same hospital, they told me that if I didn’t have the gall bladder out within two days, I’d be dead.

I filed a complaint about the doctor later. Nothing was done and he continued to practice until retirement.

That same provider sent me to a spine doctor. They were trying to figure out if the pain was coming from my back. The doctor said I needed to exercise more and do yoga, and insisted I get corticosteroid injections into my spine. I dutifully obliged the doc, getting multiple injections with no positive result. They only made the pain worse, so much so that we had to beg the doctor to stop scheduling me for them.

In 2018, at the age of 35, I was finally diagnosed with hypermobile-type Ehlers-Danlos Syndrome (EDS), a connective tissue disorder that explained my lifetime of sprains, dislocations and growing pains. I also found out that those “miracle” epidural and corticosteroid injections had further damaged my connective tissues.

That damage occurred when, prior to my EDS diagnosis, I had been given both ciprofloxacin and levaquin antibiotics to treat my chronic sinus infections. Both of those medications weakened my body’s tendons and, four years later, still give me pain. The warning labels on those antibiotics specifically say they are not for people with connective tissue disorders like EDS.

People have looked at me throughout my life and accused me of everything from faking, to lying,to being a hypochondriac. I’ve been told that it’s my weight, accused of taking methamphetamine (due to my near-scurvy levels of vitamin D and having to have all of my teeth removed) and much more, all while being told, in spite of the evidence on my chart, that I am “fine” because I somehow look fine.

When I look at me, I don’t see “fine.” I see a woman who barely sleeps because of excess adrenaline due to EDS. I see a woman who has nearly died due to medical negligence. I see a woman who has permanent nerve damage due to that same negligence. I see a woman who was used by many providers as a guinea pig for their pet projects to prove that I really was “fine.”

I see a woman who now suffers from severe post-traumatic stress syndrome, as well as Impostor syndrome, due to all the times she was called a liar in spite of mountains of evidence to the contrary. I see a woman who survived in spite of it all.

Most of all, I see a woman who fights to be treated like a person with a chronic condition, multiple comorbidities and intractable pain, instead of a person who is actually “fine.” But, maybe that’s just me. 

Mikki Ingram lives in New Mexico. Mikki is a proud supporter of the Ehlers- Danlos Society.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.