FDA Approves Stem Cell Trials for Coronavirus

By A. Rahman Ford, PNN Columnist

As the U.S. comes to terms with the severe and often deadly consequences of the COVID-19 outbreak, novel medical interventions are being sought to stem the tide of casualties.

President Trump has touted the use of hydroxychloroquine to treat coronavirus, while the Food and Drug Administration has approved clinical trials for the anti-viral drug remdesivir and blood plasma from those who have recovered from COVID-19.

The FDA has also quietly approved clinical trials of stem cell therapy. The use of stem cells is intriguing because of their established immunomodulatory properties and their ability to repair injured tissue, such as the lungs that are ravaged by more severe cases of coronavirus.

A key driver of death among coronavirus cases is Acute Respiratory Distress Syndrome (ARDS), which is characterized by an explosive acute inflammatory response in the lungs, also known as a “cytokine storm.”

Currently, the main therapeutic intervention for ARDS is mechanical ventilation. However, ventilators are invasive, in short supply and they increase the risk of bacterial infections.

Several stem cell companies are following the lead of Chinese scientists, who used injections of mesenchymal stem cells (MSCs) derived from umbilical cord blood to successfully treat patients with coronarvirus infections.  

A small study recently published in the journal Aging and Disease confirmed the safety and effectiveness of MSCs in treating 7 patients in a Beijing hospital with COVID-19 pneumonia. The study’s authors found that MSC injections inhibit the overactivation of the immune system, regulate inflammatory response, promote tissue repair and improve lung function.

The FDA recently approved an investigational new drug application from Australia-based Mesoblast for intravenous infusion of its MSC product called remestemcel-L.

“The FDA clearance provides a pathway in the United States for use of remestemcel-L in patients with COVID-19 ARDS, where the prognosis is very dismal, under both expanded access compassionate use and in a planned randomized controlled trial,” Mesoblast Chief Medical Officer Dr. Fred Grossma said in a statement.

Remestemcel-L has been under development by Mesoblast for several years. It is believed to counteract inflammatory processes by inhibiting production of pro-inflammatory cytokines by white blood cells, while promoting the production of anti-inflammatory cells. The safety and therapeutic effects of remestemcel-L infusions have been evaluated in over 1,100 patients in various clinical trials.

Texas-based Hope Biosciences has also received FDA approval for a Phase II clinical trial to evaluate the safety and efficacy of MSCs in providing immune support against COVID-19. The company uses a patient’s own stem cells – referred to as autologous cells – to treat trial participants who are at a higher risk of developing severe COVID-19 symptoms.

“Most people who have been severely affected by COVID-19 had preexisting conditions. We are pre-treating participants who are at higher risk of developing severe COVID-19, with the belief that we can prepare their immune systems, giving them their best chance to fight the virus,” said Donna Chang, President and CEO of Hope Biosciences.

Celltex Therapeutics, another Texas-based company, has applied to the FDA for emergency expanded access to its autologous MSCs to treat COVID-19. Celltex uses proprietary technology that isolates, multiplies and stores MSC’s derived from fat tissue for use in regenerative therapy for a number of conditions, including vascular, autoimmune and degenerative diseases.

New Jersey-based Celularity has received FDA approval to begin a trial of stem cells derived from human placentas – what the company calls “Natural Killer” cells. Celularity’s product – CYNK-001 – has already been used safely in patients with leukemia and multiple myeloma.

Natural killer cells play a key role in the body’s natural defense against viral infections. Former New York Mayor Rudy Guliani recently discussed the trial with Celularity founder and CEO Robert Hariri on his YouTube channel.

The FDA’s current effort to speed these therapies to Americans who need them is laudable. However, its effort could be enhanced exponentially by loosening its restrictions on autologous stem cells more generally. When the health of so many Americans is imperiled and the avenues for treatment are so few, waiting is not an acceptable option.

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.

I Was Lied to by My Pharmacist

By Colleen Sullivan, Guest Columnist

I wrote an article years ago titled "Humiliated by a Pharmacist" about how difficult it is to be a chronic pain patient and to get prescriptions filled for pain medicines.

I would love to report things are better now, but sadly the truth is they aren't.

I was diagnosed with Mixed Connective Tissue Disease (MCTD) in 2001. Having MCTD basically means a person has two or more overlapping autoimmune conditions. Mine are dermatomyositis, rheumatoid arthritis and psoriatic arthritis. These are all very painful conditions to have.  

Since I've been dealing with MCTD for so many years, I've dealt with a lot of different pharmacists and learned a few things.

Whenever I enter a pharmacy for the first time, I like to speak with the manager, explain my conditions and what I need from them. Then, I ask what they need from me and if they are willing to work with me. I just want to make sure we understand each other and are on the same page. 

Picking up my prescriptions went smoothly for awhile. It was still stressful and scary to approach the dreaded pharmacy counter and hand over my prescription for an opioid. They still looked at the Rx and up at me with judgmental eyes. They still had an attitude and no empathy whatsoever.  

COLLEEN SULLIVAN

But I managed to find a place and a head pharmacist who was willing to work with me. It was a small pharmacy that wasn't part of a big chain and I thought they weren't going to be the "med police" like Walgreens. You know what I mean: Pharmacists who think they know more than your specialist and that it's somehow their job to judge if you're worthy of your medicine or not. 

This pharmacy is located in the same building as my pain specialist, which I thought was great.  First, if they have any questions or problems, my doctor is right upstairs. Second, it's super convenient being one floor below. I already have to drive 4 hours round trip to see my doctor in Homestead, Florida because there are no doctors in the Florida Keys willing to treat any pain patients. 

So, I went to this place and spoke to the owner and head pharmacist, Claude, who said it'd be no problem at all and he'd be happy to work with me. He assured me they have a special relationship with a drug distributor and a backup vendor as well. I was finally able to relax and not have a flare up every month from the stress of going to a pharmacy.  

Things were good for six months or so, but then suddenly the whole staff started acting weird towards me. Here we go again, I thought. They started insisting I call them days in advance every month to remind them I'm a customer of theirs and to order my medication. I didn't mind doing that, but the more I thought about it, isn't that their job?

They'd assure me on the phone that everything was good, they ordered it, and it'd be there for me when I needed it.  

Then one day I made the two hour drive there and handed over my prescriptions. They went to the back and whispered to one another. That made me extremely anxious. Then, they came up and said, "Sorry, we don't have it." 

I stood there frozen in disbelief before asking, "Don't you remember talking on the phone with me and assuring me you had it?"  

Claude just shrugged his shoulders and said, "I can't help you. Sorry. I can order it now." 

Order it now? That means I would have to make the 4-hour round trip drive the next day just to pickup a prescription.  

This happened from then on, almost every month. When they didn’t have my meds, sometimes Claude would nonchalantly say, "Just drive around and look for it."  

JUST DRIVE AROUND AND LOOK FOR IT?

If you walk into a new pharmacy with an opioid prescription, it never goes well.  They look at it, look back at you and say, “We don’t have it.” They don't look in the back. They don't check the computer. They just say no. 

One thing you should know about me is I really hate confrontation. Stress makes my conditions worse, so I try to avoid it at all costs. I never argue with them. I meekly walk away and, out of desperation, cry in my car. 

I kept trying to get my prescriptions filled at this small pharmacy, because each time they'd apologize profusely and say it was an oversight and won't happen again.  

One of the last times I went there, I called in advance again. Claude says, "No problem. I ordered it and it's here. I'm looking at it. No worries."  

I get there and he says "Nope, we don't have it. It’s a problem with the distributor. Wait a couple of days and they'll get it." The whole time he's talking, I'm thinking, “You lied to me. Why did you lie?” 

So I wait. Three days later, I call and Claude says he can't get it. I end up having to go to Walgreens -- and that's a whole other story -- but eventually Walgreens gets it for me that month with stipulations.   

But now I'm three days behind in my medication. I have to get infusions every month on a particular day and Claude is well aware of that. Being three days off means two 4-hour round trip drives a month instead of one.

The next month. I called a week ahead because Claude had assured me he would work it out. But on the call he says, "Sorry, it's still a problem with the distributor."  

Out of curiosity, I asked who was the distributor. He tells me it's Cardinal Health.  

I decided to call Cardinal myself and within 20 minutes I find out there is no issue on their end and they can ship it to that pharmacy within a day. I think, this is great! Problem solved and I don't have to keep bothering Claude.

I called the pharmacy to tell Claude the good news and he was furious that I called Cardinal. He's literally yelling at me over the phone saying, "How dare you!" and "Who do you think you are?"  

I thought I wasn't just helping myself, but the pharmacy as well with the distribution problem they kept telling me about. Claude then refuses to receive the shipment from Cardinal and says they no longer want my business because it's "too much work.” He says he's done with me and tells me not to come into his pharmacy again. 

After hanging up and crying for 20 minutes, I start to realize there never was a distribution problem. It was all just a lie and he’s angry at me because I figured it out. Keep in mind this is two days before I'm supposed to refill. Because of his lies, I now had 2 days to restart the process of finding a whole new pharmacy. 

Honesty, it's sad that chronically sick people are being treated like this by medical professionals. All Claude really had to do was be honest and say, "I'm not comfortable working with you anymore. I will fill them for you one more time, so you'll have a month to figure something else out."  

If he could've just been professional and told the truth, there would have been no problem.  

Colleen Sullivan lives in Florida.  

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

DEA Allowing More Production of Opioids

By Pat Anson, PNN Editor

Faced with growing concerns about drug shortages, the U.S. Drug Enforcement Administration has increased the production quotas for some opioid pain medications and other controlled substances.

The move is in response to reports that hospitals are experiencing shortages of injectable fentanyl, morphine and hydromorphone, which are used as analgesics to keep COVID-19 patients comfortable while on ventilators.

“DEA is committed to ensuring an adequate and uninterrupted supply of critical medications during this public health emergency,” acting DEA Administrator Uttam Dhillon said in a statement.  “This will ensure that manufacturers can increase production of these important drugs, should the need arise.”

The emergency order signed by Dhillon increases 2020 production quotas by 15 percent for some Schedule II controlled substances, including fentanyl, morphine, hydromorphone, codeine, ephedrine and pseudoephedrine, as well as other drugs used in their manufacture.

Although some of those drugs have been listed for years on an FDA database of drug shortages, the DEA said as recently as three weeks ago that it was “unaware of any shortages of controlled substances at this time.”

In addition to pain medication, Dhillon’s order increases the annual production quota (APQ) for methadone, which is used primarily to treat opioid addiction. The order also raises the amount of Schedule III and IV controlled substances that can be imported into the United States, including ketamine, diazepam, midazolam, lorazepam and phenobarbital, which are also used to treat patients on ventilators.

“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of these substances as the country moves through this public health emergency,” Dhillon said in the order.

“Although the existing 2020 quota level is sufficient to meet current needs, DEA is acting proactively to ensure that — should the public health emergency become more acute — there is sufficient quota for these important drugs.”

Shortages Began Before Coronavirus

The DEA began aggressively cutting the supply of opioids in 2016 during the Obama administration. The trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third by 2021.

As recently as last December, the agency reduced 2020 production quotas for hydrocodone by 19 percent and oxycodone by 9 percent. The supply of hydromorphone, oxymorphone and fentanyl was also cut.

Some health officials warned months ago – before the coronavirus outbreak -- that the cuts went too far.

“Some of these medicines, injectable fentanyl and hydromorphone specifically, have been subject to recent and frequent shortages, hindering the ability of doctors and hospitals to conduct critical surgeries and essential patient care,” Corey Brown, Executive Director of Government Affairs for Sanford Health, which operates 44 hospitals in the Midwest, warned in an October 14 letter to the DEA.

“There remains a legitimate need to assure that patients needing surgery and those with short-term or chronic pain in hospitals (or hospice) have monitored access to pain management medications. We are concerned that additional reductions in quotas of these vital medicines may further impact the ability of medical professionals across the country to provide needed care and comfort to patients in a hospital or hospice setting.”  

Last week the DEA issued an order allowing drug manufacturers to increase their inventory of Schedule II controlled substances. But no increase in the production quota was made at the time. A senior DEA official told Reuters the quotas were “completely sufficient” to meet high demand.

The agency changed course after receiving a joint letter from the American Medical Association, American Society of Anesthesiologists, Association for Clinical Oncology and the American Society of Health-System Pharmacists warning that injectable drug shortages were affecting the care of coronavirus patients.  

“Injectable opioid medications such as these are vital for sedation, pain management, and interventional procedures. While oral dosage forms may be available, these are not clinically indicated for ventilation,” the letter said. “Without sufficient IV opioid supply, patients will suffer.”

Once the coronavirus emergency ends, DEA said it would “reevaluate demand and adjust APQ levels as needed.”

Surgery Patients Face Delays as Coronavirus Cripples Hospitals

By Will Stone, Kaiser Health News

The federal government has encouraged health centers to delay nonessential surgeries while weighing the severity of patients’ conditions and the availability of personal protective equipment, beds and staffing at hospitals.

People with cancer are among those at high risk of complications if infected with the new coronavirus. It’s estimated 1.8 million people will be diagnosed with cancer in the U.S. this year. More than 600,000 people are receiving chemotherapy.

That means millions of Americans may be navigating unforeseen challenges to getting care.

Christine Rayburn in Olympia, Washington, was diagnosed with breast cancer in mid-February. The new coronavirus was in the news, but the 48-year-old did not imagine the outbreak would affect her. Her doctor said Rayburn needed to start treatment immediately. The cancer had already spread to her lymph nodes.

“The cancer tumor seemed to have attached itself to a nerve,” said Rayburn, who was a schoolteacher for many years. “I feel pain from it on a regular basis.”

After getting her diagnosis and the treatment plan from her medical team, Rayburn was focused on getting surgery as fast as possible.

Meanwhile, the coronavirus outbreak was getting worse, and Seattle, just an hour north of where Rayburn lives, had become a national focal point. Rayburn’s husband, David Forsberg, began to get a little nervous about whether his wife’s procedure would go forward as planned.

“It did cross my mind,” he said. “But I did not want to bother with that possibility on top of everything else.”

Two days before Rayburn’s lumpectomy to remove the tumor, Forsberg said, the surgeon phoned, “pretty livid” with bad news. “She said, ‘Look, they’ve canceled it indefinitely,'” Forsberg remembered.

The procedure had been scheduled at Providence St. Peter Hospital in Olympia, a facility run by Providence Health & Services. Across Washington, hospitals were calling off elective surgeries, in order to conserve the limited supply of personal protective equipment, or PPE, and to prevent patients and staffers from unnecessary exposure to the new coronavirus.

“It just felt like one of those really bad movies, and I was being sacrificed,” Rayburn said.

“It was like we just got cut off from the experts we were relying on,” her husband said.

The hospital said it would review the decision in a few weeks. But Rayburn’s surgeon said that was too long to wait, and they needed to move to Plan B, which was to begin chemotherapy.

Originally, chemotherapy was supposed to happen after Rayburn’s tumor surgery. And rearranging the treatment plan wasn’t ideal because chemotherapy isn’t shown to significantly shrink tumors in Rayburn’s type of breast cancer.

Still, chemotherapy could help stop the cancer from spreading further. But as the couple figured out the new treatment plan, they ran into more obstacles.

“She needed an echocardiogram, except they had canceled all echocardiograms,” said Forsberg.

They spent days on the phone trying to get all the pieces in place so she could start chemotherapy. Rayburn also started writing to her local lawmakers about her predicament.

Hospitals Prioritize Urgent Cases

In mid-March, Washington Gov. Jay Inslee banned most elective procedures, but he did carve out exceptions for certain urgent, life-threatening situations.

“It actually said that it [the ban] excluded removing cancerous tumors,” Rayburn said.

Providence hospitals use algorithms and a team of physicians to figure out which surgeries can be delayed, said Elaine Couture, chief executive of Providence Health in the Washington-Montana region.

“There are no perfect decisions at all in any of this,” said Couture. “None.”

Couture would not talk about specific patients but said she assumes other cases were more urgent than Rayburn’s.

“Were there other patients that even had more aggressive types of cancer that were [surgically] completed?” Couture said. “As sick as you are, there can be other people that are needing something even sooner than you do.”

Couture said hospitals are burning through supplies of masks, gowns and gloves and need to make tough calls about elective procedures.

“I don’t like that, either, and it’s not the way that we want our health care system to work,” Couture said.

Across the Providence hospital system, personal protective equipment is being used much faster than it can be replenished, she said.

No Single Standard

At the American Cancer Society, Deputy Chief Medical Officer Dr. Len Lichtenfeld is hearing from patients across the country who are having their chemotherapy delayed or surgery canceled.

“There was someone who had a brain tumor who was told they would not be able to have surgery, which was, basically, and appears to be a death sentence for that patient,” said Lichtenfeld.

This is uncharted territory for cancer care, he said. Hospitals are making these “decisions on the fly” in response to how the pandemic looks in a particular community. “There is no single national standard that can be applied. I am afraid this is going to become much more common in the coming weeks.”

The cancer society recommends that people postpone their routine cancer screenings — for now.

The American College of Surgeons has published guidance on how to triage surgical care for cancer patients. But Lichtenfeld said every decision ultimately depends on the availability of resources at the hospital and the pressures of COVID-19. In Washington state, which has been hit hard, hospitals are shifting surgical space and beds away from other kinds of treatment.

“We need to forecast two to three weeks down the line when there are more patients that are ill,” said Dr. Steven Pergam, medical director of infection prevention at the Seattle Cancer Care Alliance. “We need to make sure there’s adequate bed capacity.”

Pergam said the care alliance is adjusting treatment plans and, at times, avoiding procedures that would keep cancer patients in the hospital for a prolonged period.

“It really depends on the cancer and the aggressive nature of it,” he said. “We have looked at giving chemotherapy in the outpatient department and changing the particular regimens people get to make them less toxic.”

But Pergam said they expect to keep doing urgent surgeries for cancer patients, even as the pandemic grows worse.

Christine Rayburn in Olympia was steeling herself for the months of chemotherapy to come: staying inside her home and even avoiding contact with her adult daughters, to avoid any possible exposure to the coronavirus.

Then, two weeks ago, the surgeon called again. She had persuaded the hospital to allow the surgery after all, 10 days later than initially planned.

Rayburn and her husband wonder what would have happened if they hadn’t spoken up or pushed to get her lumpectomy back on the hospital’s surgical schedule. Forsberg said it’s possible they could have ended up without the care Rayburn needed.

“If we didn’t say anything, in my mind that may be where we would be at,” he said. “But in our minds, that was not an option.”

This story is part of a partnership between NPR and Kaiser Health News (KHN), an editorially independent program of the Henry J. Kaiser Family Foundation.

Can Vitamin C Treat COVID-19?

By Madora Pennington, PNN Columnist

Viral infections like COVID-19 are difficult to treat. Unless and until a targeted anti-viral drug or vaccine is developed, symptomatic support is what is given to patients to ease suffering and prolong life -- until their own body hopefully defeats the coronavirus.

While most coronavirus infections are mild or even lack symptoms, to vulnerable patients they can be devastating. The virus can infect various organs, including the brain, lungs and nervous system, which leads to a cascading response of damaging inflammation. Patients can die from respiratory failure or septic shock, ironically caused by an over-reaction of their own immune system battling the virus.

One adjunctive therapy that emerged from the desperation to save patients in Wuhan, China is intravenous ascorbic acid. Yes, that is Vitamin C. A placebo-controlled study has begun in Wuhan to determine if Vitamin C infusions are helpful in treating 140 patients with coronavirus pneumonia. A similar clinical study is underway in Italy.

Doctors in New York are currently administering Vitamin C intravenously to coronavirus patients in large doses that are well above the recommended daily dose.

"I have to hope that this, or any new idea, may help," Peter McCaffery, Professor of Biochemistry at the University of Aberdeen in the UK, told Newsweek.  

"Just to reiterate though, taking large doses of Vitamin C tablets would be very unlikely to protect you from COVID-19 -- unless you were actually Vitamin C deficient, which with a normal diet is quite rare."

McCaffery says Vitamin C is relatively safe because, unlike many other vitamins, it does not build up to toxic levels. The worst side-effect is a potential kidney stone. Large amounts of C taken orally can also upset the stomach.

Previous studies have found that Vitamin C can help prevent death from the deadly complication of sepsis. Scientists believe Vitamin C stops the surge of immune cells that lead to lung destruction and helps reduce fluid buildup in the lungs. Vitamin C helps modulate the immune system, meaning it helps the immune system function properly, not over-reacting and not under-reacting. It also has antiviral properties.

Important for Overall Health

Vitamin C is critical for the maintenance of body functions and normal physiology. It helps the body maintain homeostasis -- the constant adjustments the body makes to keep conditions stable. For example, when a person eats and experiences a rise in glucose, insulin is produced to bring sugar levels down to normal. A breakdown in the body’s ability to maintain homeostasis is what leads to diabetes.

Vitamin C is essential for the formation of collagen, which is everywhere in the human body, gluing everything together. It is necessary for wound healing.

Vitamin C also supports the development of neurons and plays a role in learning and memory. Studies have shown that people with higher concentrations of Vitamin C are more cognitively intact compared to cognitively impaired individuals.

Some studies have shown Vitamin C can shorten the length of a cold, prevent it entirely under certain circumstances, and also reduce flu symptoms. But more research is needed in this area because findings have been mixed. Scientists suspect inconsistent results may be due to the variability of an individual’s ability to absorb Vitamin C and handle oxidative stress.

Some people need more Vitamin C than others to achieve healthy levels of ascorbic acid. Oxidative processes are especially altered in patients with obesity, cancer, neurodegenerative diseases, hypertension and autoimmune diseases. Lower concentrations of Vitamin C are also found in patients with metabolic syndrome.

Nearly all mammals manufacture their own Vitamin C when they are ill or injured. But chimpanzees and humans have a broken copy of the C manufacturing gene. We must obtain ours from food.

During the Age of Sail, a disease of profound Vitamin C deficiency — scurvy — killed an estimated 2 million sailors. At the time, no one knew Vitamin C was such a vital nutrient. Ships set sail on long voyages without enough food that contained it.

Scurvy was a terrible disease and a terrible way to die. Initially overcome with severe fatigue and weakness, sailors became unable to think or work. This created suspicion that laziness itself caused this mysterious disease.

As the body became more and more depleted of Vitamin C, healed fractures re-broke. Old wounds reopened and bled. Bruises formed at the slightest touch. Gums bled and teeth fell out. Joints ached. Flesh turned black and gangrenous. Fatal aortic ruptures or brain bleeding came on suddenly. Scurvy this severe is rarely seen in the modern world.

My interest in Vitamin C is very personal. I have an inherited collagen disorder called Ehlers-Danlos Syndrome (EDS), a poorly understood disease. Vitamin C loading is recommended for my condition, as many of my symptoms are similar to scurvy.

My doctor and I discovered I benefit exponentially from injecting Vitamin C, rather than taking it orally. Why is a mystery. For those interested in oral supplementation, liposomal C is the best choice.

Madora Pennington writes about Ehlers-Danlos and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

How Has the Coronavirus Affected You? Take Our Survey

By Pat Anson, PNN Editor

Are you worried about becoming infected with the coronavirus? Are you self-isolating at home? When you go out, do you wear face masks and gloves? Can you even find face masks and gloves?

Those are some of the questions we’re asking in a survey designed to measure the impact of the coronavirus on people living with chronic pain and/or chronic illness. PNN is partnering with the International Pain Foundation (iPain) and the Chronic Pain Association of Canada (CPAC) to see how people who are most vulnerable to COVID-19 are coping with a life-altering pandemic.

“We are all aware of the coronavirus and the effect it is having on our society as a whole. However, many don’t realize the negative effects it has on people living with chronic pain. Chronic pain sufferers often have conditions that render them more vulnerable to this virus than the general public. And we are concerned about access to vital medical services and medications that patients require on an on-going basis,” says Barry Ulmer, Executive Director of CPAC.

“It is important that as many people as possible take the survey. That will allow us to measure the impact of COVID-19 on people with chronic pain or chronic illness and then address those problems with our policymakers and regulators. This is important so please take a few minutes to participate.”

“People with chronic conditions are more vulnerable to catching a cold, viruses and other communicable diseases,” says Barby Ingle, the founder and president of iPain. “Many are isolated at home, have little contact with the outside world, and are unable to get protective gear such as masks. That increases their anxiety and stress, which can worsen their underlying condition.

“More personally, as a pain patient who is at high risk for the coronavirus, I would love to connect and evoke discussions with people who are dealing with a dehumanizing experience.”

Vulnerable Populations

Who is most vulnerable to COVID-19? A study of people infected in China found that those over the age of 80 have the highest fatality rate of any age group -- nearly 15 percent -- followed by people in their seventies (8%) and sixties (3.6%).  The study found that cardiovascular disease, diabetes, chronic respiratory disease, hypertension and cancer also raise the risk of death.

The CDC goes a bit further, warning that obesity, smoking, poorly controlled HIV or AIDS, and prolonged use of corticosteroids, prednisone and other immune weakening medications also increase the risk.

In a recent column, Dr. Lynn Webster suggested that chronic pain may weaken immune systems.

“People with chronic pain may be more susceptible to viruses in general, because chronic pain can change the way our immune systems work. McGill University researchers found that chronic pain changes the DNA in T-cells, a type of white blood cell essential for immunity. Researchers were surprised by the number of genes affected by chronic pain,” Webster wrote.

Our survey should only take a few minutes. You’ll be asked a series of multiple-choice questions. Select the answer that best describes your situation or leave it blank if no answer applies to you. You'll have an opportunity at the end of the survey to provide more detail or discuss other issues and concerns.

To take the survey, click here. Your feedback is important!

Pain, Prison and a Pandemic: Life Behind Bars for Former CEO of U.S. Pain Foundation

By Pat Anson, PNN Editor

Self-isolation, social distancing and good hygiene may be the order of the day for most of us during the COVID-19 crisis. But they are next to impossible for Paul Gileno.

“Basically 100 of us are locked in one building, all sharing the same bathrooms and common areas. I sleep on a top bunk in a room of 30 people which is all open,” says Gileno.

Gileno is the founder and former CEO of the U.S. Pain Foundation, which once billed itself as the nation’s largest advocacy group for pain patients. Today he is better known as Inmate #26388014 at Federal Prison Camp Schuylkill, a minimum-security facility in Minersville, Pennsylvania.

Like other federal prisons, Schuylkill has been locked down in an attempt to limit the spread of the coronavirus. All visits have been suspended and inmates spend little time outside of their cells and dorm areas.

“The CO's (correctional officers) and staff do not wear masks and they come from the outside world. They say they test them, but that consists of taking their temperature. They won’t let us out to get fresh air, only to go eat and come back which is less than 10 minutes,” Gileno says. 

In January, Gileno began serving a one-year sentence at Schuylkill for embezzling over $1.5 million from U.S. Pain. He could have gotten up to 25 years, but federal prosecutors agreed to ask for a lesser sentence when Gileno pleaded guilty to fraud and tax evasion.

“I was horrified how pain patients are treated in the outside world. In prison it’s 100 times worse,” wrote Gileno, who recently began corresponding with this reporter by letter and email.

“I am treated terrible here, all of the inmates are treated horrible here. Food is either expired or almost inedible and they are constantly doing raids, shakedowns and lockdowns, sometimes making us stand in the freezing cold for hours while they search our cells.”

Gileno abruptly resigned from U.S. Pain in 2018, but it took nearly a year for the Connecticut-based charity to disclose the full extent of the “financial irregularities” that he was accused of.  

An audit revealed that Gileno used the foundation’s bank account as his own personal piggy bank, writing checks to pay expenses such as his mortgage, car payments and a visit to Universal Studios.

There were also questionable business decisions that were far outside the scope of U.S. Pain’s mission, such as a $100,000 loan to Gileno’s brothers and $165,000 spent on a failed bakery.

The brazen misuse of donated funds somehow went undetected for three years by U.S. Pain’s board of directors and vice-president Nicole Hemmenway, who has been “interim CEO” ever since Gileno’s departure. The non-profit’s board and office staff remain largely the same.

PAUL GILENO

“I don’t know what else I can say about U.S. Pain, except I certainly made mistakes and I mismanaged. But I took full responsibility and I am paying the ultimate price in many ways,” Gileno wrote.

“Sadly the people I loved and respected and who I trusted and hired totally disowned me, left me and refused to handle this in a way where I did not suffer as much as I am suffering. I owned up to my mistakes and never thought I would be treated as I was. With that said, I want U.S. Pain to succeed and I want it to flourish.”  

Gileno says he sleeps on a two-inch mattress that has aggravated his chronic back pain. His only relief comes from ibuprofen or Advil, which he buys at a prison commissary. A doctor visits once a week, but sees only a handful of inmates.

“They are overwhelmed and do not care,” Gileno wrote. “I have met men in so much pain it’s tragic. We have no options here, no physical therapy, no medical attention, no access to any sort of therapy that can relieve some of our pain.

“I must say I am suffering more now in pain than ever before and my anxiety is at an all time high. And they do not treat that either.”

The worst part of prison life for the 47-year old Gileno is that he can’t see his wife and two sons due to the coronavirus lockdown. Schuylkill is a three-and-a-half-hour drive from their home in New York state. Telephone calls are limited to 15 minutes and emails are restricted.

Because of the pandemic, Attorney General William Barr recently ordered the early release of inmates from three federal prisons where coronavirus outbreaks have occurred. But so far there’s no word of that happening at Schuylkill.

“There is a lot of talk about freeing federal inmates but we have not been told anything nor have they informed us if there is a procedure in place,” Gileno says. “I am hoping they are not waiting until it gets here. I am one of the high risk patients they should put on home confinement. Besides all of my pain conditions and RSD, I have chronic asthma and chronic bronchitis.”

Gileno is currently scheduled for release in November. When he gets out, Gileno would like to return to patient advocacy and perhaps run a support program for prisoners in pain.  

“I just hope people with pain know that I am always going to fight for them and all patients and that was always my goal when starting the foundation. I can’t wait to get out to be a patient advocate again and help who I can,” he wrote.

Study Finds ‘Good Evidence’ Acupuncture Can Treat Migraine

By Pat Anson, PNN Editor

Recent advances in treating and preventing migraines with new drugs have created a “treatment revolution” in migraine therapy.  But a more ancient technique may work even better, according to a small study recently published in the British Medical Journal (BMJ).  

Researchers in China say acupuncture was up to four times more effective than a non-steroidal anti-inflammatory drug (NSAID) in reducing attacks of episodic migraine without aura.

The study involved 147 migraine patients treated at seven hospitals in China from 2016 to 2018. The patients were divided into three groups; with one group getting 20 sessions of manual acupuncture, another group getting sham (fake) acupuncture, and the third group getting “usual care” that included use of the NSAID diclofenac.  

By the end of the study, patients who received acupuncture were having 2.3 fewer migraine attacks a month, compared to 0.4 and 1.6 fewer attacks for the usual care and sham groups, respectively. 

“In this study in acupuncture naive patients with episodic migraine without aura, 20 sessions of manual acupuncture produced a relatively long lasting reduction in migraine days and migraine attacks compared with sham acupuncture and usual care,” researchers reported. “Overall, the therapeutic effects in the manual acupuncture group occurred earlier, were larger, and might last longer.”

‘Useful Additional Tool’

According to one migraine expert, the study shows that acupuncture can be a “useful additional tool” in migraine therapy.

"We now have good evidence that acupuncture is an effective treatment for episodic migraine," writes Heather Angus-Leppan, MD, a neurologist at the Royal Free London NHS Foundation Trust, in a BMJ editorial. "(The study) helps to move acupuncture from having an unproven status in complementary medicine to an acceptable evidence-based treatment."

The study drew a mixed reaction from readers in The Daily Mail.

“Great if it works for you, but it did absolutely nothing for me except wasted money I could Ill afford,” one poster wrote.

“Unfortunately, never worked for me. But good for those who it did. Migraines are a debilitating thing to have,” said another.

“I suffered weekly migraines for decades before trying acupuncture, given by a lady who trained for years in China. After the first session the migraines stopped completely for around 20 years. When they recurred, I tried acupuncture again, from the same lady, and it had no effect at all. I'd still say it's really worth giving it a go,” wrote another poster.

“I had severe and frequent migraines as a teenager - the doctors tried everything from beta blockers to a dairy free diet. Acupuncture was the only thing that really worked - it broke the cycle and my migraines became less severe and more infrequent,” another poster said. “Now I rarely have a migraine at all and if I get a headache using pressure points really helps. It worked for me but may not work for everyone.”

Migraine affects about a billion people worldwide and 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can also cause nausea, vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

As many as 3 million Americans receive acupuncture treatments, most often for relief of chronic pain. While there is little consensus in the medical community about the effectiveness of acupuncture, the Centers for Medicare & Medicaid Services (CMS) recently said it would start covering acupuncture for Medicare patients with chronic low back pain.

Coronavirus Is Now More Deadly Than Opioid Crisis

By Roger Chriss, PNN Columnist

The coronavirus pandemic is claiming lives daily. The number of confirmed infections worldwide passed one million today, with over 51,000 deaths.

Case counts in the United States are rising fast, with nearly a quarter of a million people infected and over 5,600 deaths. Over a thousand Americans are now dying every day from COVID-19.

This means that the pandemic is causing more deaths in the U.S. per day than the opioid crisis did in 2017, its worst year. Over 47,000 people died of opioid-related overdoses that year, according to the CDC, or about 128 people a day.

The worst is still ahead of us. The White House coronavirus task force projects that between 100,000 and 240,000 Americans will die from COVID-19.  

Other estimates are higher and some lower. Researchers at the University of Washington project that over the next four months approximately 81,000 people will die from the virus. In other words, the pandemic will kill more Americans in 2020 than opioids did in any year.

If things get worse, because the virus turns more virulent, medical resources dwindle or the public health response weakens, then the estimated death toll may rise into the millions.

Most of us couldn't do anything about the overdose crisis, because it was not an infectious disease epidemic. Practices like social distancing, scrupulous hygiene and self-isolating do not matter in a drug overdose crisis. But for a pandemic viral illness, they are vital.

The importance of distancing cannot be understated. As the University of Oxford Mathematical Institute explains, without distancing an infected person may pass the virus to three people in a week, which in six weeks leads to 1,093 new cases. However, if everyone reduces their contacts by a third, then each infected individual will only infect two others.

Hygiene is similarly important. Regular scrubbing of hands with soap and water, sneezing or coughing safely into an elbow, and strict avoidance of hand-to-face contact can help break the chains of transmission, reduce infection and prevent deaths.  

White House coronavirus response coordinator Dr. Deborah Birx told NBC News that keeping the number of deaths below 200,000 will require that “we do things almost perfectly.”

Early evidence suggests that social distancing and other public health measures are already helping in the San Francisco Bay area and the Seattle-Puget Sound area. But continued vigilance is needed.

“Our model looks at the data to determine if social distancing measures are slowing the spread of COVID-19,” said Dr. Daniel Klein, computational research team leader at the Institute for Disease Modeling. “While the results indicate an improvement, the epidemic was still growing in King County as of March 18th. The main takeaway here is though we’ve made some great headway, our progress is precarious and insufficient.”

Opioid overdoses led to far too many deaths. The pandemic stands to kill far more and lead to vastly more illness. There is a lot we can each do to avoid becoming sick ourselves and protect our families, friends and communities.  

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.

Finding Resiliency in a Pandemic

By Mia Maysack, PNN Columnist

This pandemic has broken my heart for multiple reasons, aside from the obvious ones. Knowing so many are displaced, unemployed, and losing things they've worked their lives for.

Being aware of the impact, watching the number of those infected or lost rise, as well as repeatedly witnessing countless people flat out ignoring the simple rule of staying home, has exposed multiple layers of the broken foundation that our country is built on.

If we don't address these issues, it's my belief that this crisis is only just the beginning.  

Many believe that “healthcare is a basic human right." Though I couldn't agree more with the ideology, why is it this statement carries more weight when proclaimed by healthy people, yet chronic pain patients beg regularly to be seen, heard, treated or even believed?

The changes in the healthcare system in response to the coronavirus have been astounding. Suddenly telehealth is in vogue and physicians are returning phone calls. The AMA wants the rules waived on opioids and other controlled substances. And complimentary healthcare resources and advice are being released on endless platforms. Does it really take a pandemic in order to do right and join forces?

So be it.  Instead of remaining perturbed, I've chosen to rejoice over the fact these things are possible. And I definitely plan on remembering this when the immediate threat blows over. Understanding, flexibility and convenience should remain part of our healthcare system when we re-navigate our new normal.    

Those who are healthy have been complaining about boredom, not being able to do what they want, feeling isolated and overwhelmed by changes they've been forced to make.

Welcome to everyday life for people living with chronic pain and illness!

Many who've tested positive for COVID-19 have recovered, which is something I’m grateful for -- though personally, I am unable to relate to.

There's deeply rooted disappointment in our government. The fact it took so long to create an action plan, on top of the fact the main hang-up revolved around saving the economy, not people. I suppose that isn't anything new, but it gifted us with the exposure of national shortcomings and has been a wakeup call.

There’s a saying used in politics that originated from Winston Churchill: “Never let a good crisis go to waste.”

There’s not much that is ‘good’ about this, other than the fact it is demanding we grow as individuals and come together, cultivating a greater comprehension and sense of awareness. If handled properly, many lessons can be learned from the crisis and we can implement changes in everyday life as we know it.

As people living with chronic illness or pain, we have proven that resiliency is a very real part of who we are. Remembering that can assist in calming our nerves and help us focus on what matters most.  

Toilet paper alone won't save us.  

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

Most Medical Cannabis Has Too Much THC

By Pat Anson, PNN Editor

More than 90% of the medical cannabis products advertised in the U.S. contain more tetrahydrocannabinol (THC) than is recommended for chronic pain relief, according to a large new study published in the journal PLOS ONE.

THC is the psychoactive ingredient in marijuana that makes people “high.” Previous studies have shown that medical cannabis containing about 5% THC is effective for treating neuropathic pain. But researchers at Wake Forest University found that many cannabis products sold at dispensaries contain nearly four times as much THC, similar to the amount found in recreational cannabis.

"We know that high-potency products should not have a place in the medical realm because of the high risk of developing cannabis-use disorders, which are related to exposure to high THC-content products," said lead author Alfonso Edgar Romero-Sandoval, MD, associate professor of anesthesiology at Wake Forest School of Medicine.

Romero-Sandoval and his colleagues found that over 8,500 medical cannabis products advertised online contain an average THC concentration of 19.2% -- similar to the average 21.5% THC in recreational cannabis. At least one medical cannabis product contained 35% THC.

Ironically, lower concentrations of cannabinoids (CBD) – the compound in marijuana most often associated with pain relief – were found in high THC cannabis.

“These stated concentrations seem unsuitable for medicinal purposes, particularly for patients with chronic neuropathic pain. Therefore, this information could induce the misconception that high potency cannabis is safe to treat pain,” researchers reported.

“This data is consistent with reports in which THC and CBD in products from legal dispensaries or in nationwide products from the illegal market were actually measured, which indicates that patients consuming these products may be at risk of acute intoxication or long-term side effects.”

Medical cannabis is legal in 33 U.S. states and in Washington, DC. The cannabis products analyzed in the Wake Forest study were advertised by 653 legal dispensaries in California, Colorado, Maine, Massachusetts, New Hampshire, New Mexico, Rhode Island, Vermont and Washington.

Most had THC content well above 15 percent, with Maine reporting the least (70%) and Colorado having the most (91%).

PLOS ONE

Researchers say between 60% and 80% of people who use medical marijuana use it for pain relief. High concentrations of THC put them at greater risk of intoxication, dependency and tolerance — which means higher and higher concentrations might be needed to get the same level of pain relief.

"It can become a vicious cycle," Romero-Sandoval said. "Better regulation of the potency of medical marijuana products is critical. The FDA regulates the level of over-the-counter pain medications such as ibuprofen that have dose-specific side effects, so why don't we have policies and regulations for cannabis, something that is far more dangerous?"

A recent study published in the journal Cannabis and Cannabinoid Research found that cannabis products often come with misleading labels and marketing claims.

“Widespread mislabeling of hemp and cannabis products has been documented by both independent researchers and the FDA and other organizations. Underlabeling and overlabeling of both CBD and THC content have been reported,” the authors found.

“The actual contents of available products can vary considerably from what are disclosed on the label; sometimes no CBD is present at all. Inadequate label information also poses risks of unintended, unwitting, or overconsumption of THC, the primary intoxicating compound in cannabis, as well as potentially harmful contaminants.”

Are You Back on the Pain Chain?

By Ann Marie Gaudon, PNN Columnist

Societal messages constantly tell us that we need to control any and all pain before we can be happy.

What happens when this is not possible? I’ve said it before: In order for me to be pain-free, I would have to be rendered unconscious.

Control of “clean pain” -- biological pain that can’t be fixed --  is very attractive, but in a never-ending quest to control it, we end up with the pain controlling us. That’s when “dirty pain” begins -- we focus too much attention on the negative thoughts and feelings associated with pain.

One form of dirty pain is called “Mental Scripts.” These include what our mind tells us about our pain experience. Here are some examples: 

• Searching for reasons you’re in pain: You might say to yourself, “I told you not to lift that. You know what happens when you aren’t careful!” 

• Yelling epithets to yourself in your head: Your mind might be shouting, “You hopeless idiot! You’re such a failure at life!”   

• Reciting rules you’ve established for yourself around your pain: You might tell yourself, “Exercise is not an option while I’m in pain,” or “I cannot live a good life with pain.” 

A second type of dirty pain is called, “Avoidance Behaviours.” This means anything you do or avoid doing in order to try not to feel pain. This behaviour can be particularly perilous because the act of avoiding an experience due to some feared outcome does not always reduce pain, it can actually increase pain. Here are some examples: 

• Using medications in an attempt to avoid pain altogether rather than to dampen your pain enough to live your life.  

• Refusing to exercise altogether because you are in pain. 

• Refusing to work or volunteer in any capacity because you are in pain. 

A third type of dirty pain we subconsciously engage in is called “Values Discrepancy.” This means choosing avoidance and moving far away from the life that you want to live.  

When you are knee-deep in Values Discrepancy you are living the antithesis of a life that you value. For example: 

• Giving up on a higher education because you fear the pain will not allow you to concentrate. 

• Quitting your dream job because of the pain you felt when you were there. 

• Choosing not to have a family because parenting could be difficult if you are in pain.

Avoidance behaviours (a form of trying to control) are indeed very seductive. They look like the answer. Have you ever seen an advertisement for any type of pain control? The patient takes the magic pill or treatment, the pain is completely resolved, and the patient is seen happily playing tennis or rolling around in the grass with their child.

Western culture rarely if ever shows us reality. The control paradigm is such that the more choices we make attempting to control the pain, the smaller and less meaningful our lives end up. We become stuck on the “Pain Chain.” For chronic pain patients, the manifestation of dirty pain typically looks like this:

The more we struggle against what is uncontrollable, the more we will suffer. The good news is that no one is fated to suffer from dirty pain for the rest of their lives. If you find yourself suffering from any of these symptoms, find yourself a qualified therapist in chronic pain management.

When chronic pain is part of our lives, we need more resilience, not less. We grow resilience by practicing and learning not be ordered around by our thoughts and feelings. Psychotherapy can help you with workable solutions to rise above life-draining, self-defeating patterns of behaviour.  

I once was choked off in the Pain Chain, and now I help others to unleash themselves. With the right tools, it is possible to get back to living a life in the service of our values – not in the service of our pain.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for over 30 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website.

Hospitals Plan to Ration Healthcare as Coronavirus Spreads

By Pat Anson, PNN Editor

With face masks, surgical gowns, hospital beds and ventilators in short supply, some U.S. hospitals are preparing to make stark choices about which patients to treat – and who not to treat – during the coronavirus pandemic.

The Henry Ford Health System, which operates dozens of medical centers and emergency rooms in the Detroit metropolitan area, has contingency plans to take critically ill patients off ventilators and out of intensive care if they have little chance of recovery.

“Some patients will be extremely sick and very unlikely to survive their illness even with critical treatment. Treating these patients would take away resources for patients who might survive,” the plan states. “Patients who are treated with a ventilator or ICU care may have these treatments stopped if they do not improve over time.”

Under the Henry Ford policy, patients suffering from terminal cancer, organ failure or severe trauma “are not eligible for ICU or ventilator care” and would be given pain control instead.

When a document from the 50-page plan – a letter addressed to patients informing them about the policy – began circulating outline, it was met with outrage.

“Reading that policy truly removes the usually veiled thoughts about the disabled being less than, not enough, or not fully whole. Being shown that one is not ‘eligible’ to continue living is despicable,” Koa Kai, a pain patient and advocate for the disabled, told PNN.  

“I question the ethics and danger of policies such as this, and outright reject their use. We are seeing humanity stripped down to its most basic elements now. As the hysteria continues, it continues to bring both the best and worst out in humanity.”  

Henry Ford officials were quick to point out their contingency plan was prepared for a worst-case scenario and has not yet been implemented. It was shared with other health care systems in Michigan to help them develop similar plans – which is apparently how it leaked..

“Gathering the collective wisdom from across our industry, we carefully crafted our policy to provide critical guidance to healthcare workers for making difficult patient care decisions during an unprecedented emergency,” Dr. Adnan Munkarah, Henry Ford's executive president and chief clinical officer, said in a statement.

“It is our hope we never have to apply them and we will always do everything we can to care for our patients, utilizing every resource we have to make that happen.”

Michigan reported nearly a thousand new coronavirus cases Saturday, bringing the state’s total to 4,650 cases. At least 111 people have died from the virus in Michigan – with most of the deaths occurring in the Detroit area.

Michigan Gov. Gretchen Whitmer, a Democrat who has been feuding with President Trump, told a radio station Friday that medical supply vendors told her they’ve been told “not to send stuff” to her state. Whitmer complained earlier that the number of masks and gowns sent to Michigan by the federal government was inadequate. The state reportedly hasn’t received a single ventilator.

‘We Are on the Precipice of Rationing’

Ventilators are medical appliances that force air into and out of the lungs – essentially doing the breathing for patients who are unable to breathe on their own. Connecting a sick patient to a ventilator – and taking them off – are life-and-death decisions.

“When patients’ breathing deteriorates to the point that they need a ventilator, there is typically only a limited window during which they can be saved. And when the machine is withdrawn from patients who are fully ventilator-dependent, they will usually die within minutes,” lead author Robert Truog, MD, a medical ethics professor at Harvard Medical School, wrote in an op/ed recently published in The New England Journal of Medicine.

Some hospitals in New York City are so overwhelmed with coronavirus patients they may have to start rationing ventilators and other critical medical supplies. The state has over 52,000 confirmed cases, nearly half of the nation’s total.

“Today was the worst day anyone has ever seen, but tomorrow will be worse. We are on the precipice of rationing. Needless to say, these decisions run counter to everything we stand for and are incredibly painful,” wrote Meredith Case, an internal medicine resident at Columbia/New York-Presbyterian Hospital, in a March 25 Twitter thread

Two days later, the situation had not improved.

“Yesterday brought another onslaught. Endless overheads calling for anesthesia and respiratory therapy for intubations. Friends at other hospitals having the same experiences. We are rising to a challenge that already overwhelms us,” Case tweeted. “Frustrating to realize that different things are in shortage in different places. Some will soon run out of vents, others CRRT machines, others nursing staff, others rooms or physical space.”

‘The Ethical Thing To Do’

As stark as it sounds, rationing scarce medical resources is “the ethical thing to do” during a pandemic, according to an op/ed in The New England Journal of Medicine.  

“Because maximizing benefits is paramount in a pandemic, we believe that removing a patient from a ventilator or an ICU bed to provide it to others in need is also justifiable and that patients should be made aware of this possibility at admission,” wrote lead author Ezekiel Emanuel, MD, a professor at the Perelman School of Medicine, University of Pennsylvania.

“Undoubtedly, withdrawing ventilators or ICU support from patients who arrived earlier to save those with better prognosis will be extremely psychologically traumatic for clinicians — and some clinicians might refuse to do so. However, many guidelines agree that the decision to withdraw a scarce resource to save others is not an act of killing and does not require the patient’s consent.”

Who decides which patients should be taken off ventilators? In many cases, the decision is made by a hospital triage officer or a triage committee composed of providers who have no direct responsibility for the care of a patient.  

“In the weeks ahead, physicians in the United States may be asked to make decisions that they have never before had to face, and for which many of them will not be prepared,” Dr. Truog wrote in his op/ed. “Though some people may denounce triage committees as ‘death panels,’ in fact they would be just the opposite — their goal would be to save the most lives possible in a time of unprecedented crisis.”

‘Ruthless Utilitarianism’

In response to growing concerns about healthcare being rationed during the coronavirus outbreak, the Office for Civil Rights (OCR) at the Department of Health and Human Services issued a bulletin Saturday warning healthcare providers not to discriminate against patients, regardless of age or disability.

“Our civil rights laws protect the equal dignity of every human life from ruthless utilitarianism,” said Roger Severino, OCR Director. “Persons with disabilities, with limited English skills, and older persons should not be put at the end of the line for health care during emergencies.” 

Severino was responding to a complaint from advocates for the disabled in Alabama. Under a state emergency plan, patients with “severe mental retardation, advanced dementia or severe traumatic brain injury” could be considered “poor candidates for ventilator support” during a pandemic. Patients with AIDS or compromised immune systems could also be taken off ventilators.

“Healthcare organizations incorporating this ventilator triage protocol into their disaster plans and attempting in good faith to follow it will be considered to be in compliance with the standard of care necessitated by the prevailing proclaimed respiratory disaster,” the Alabama plan states.

How Fear Can Make the Coronavirus Worse

By Dr. Lynn Webster, PNN Columnist

At 7:09 am on Wednesday, March 18, 2020, a 5.7 magnitude earthquake struck Salt Lake City, Utah — the city in which I live. Though it caused little damage, the earthquake created immense fear. 

This occurred during a week in which the Dow Jones Industrial Average plunged, setting a record for the largest stock market drop in U.S. history. Although only about half of U.S. citizens own stocks, the impact of the enormous amount of wealth lost will have a ripple effect on every American. 

In addition, like the rest of world, we face the coronavirus pandemic. Because Salt Lakers have experienced a trifecta of calamities, our fear is palpable.

But intense fear is not limited to Salt Lake City. It is ubiquitous. People all around the world are experiencing nearly unprecedented levels of fear in the face of the pandemic. As a friend of mine said, it feels like an apocalypse of biblical proportions.

Fear is a primordial emotion that can protect humans from danger, but it can also be destructive.

Typically, fear is proportional to three factors: the magnitude of the threat; how well we can predict and control the potential harm; and whether we can see that the threat's end is in sight. Since we know so little about the novel coronavirus, all three factors contribute to our fear.

A 2016 paper published in the journal Disaster Health described Fear-Related Behaviors (FRBs) that occur during mass threats to a society. The study found that FRBs have four possible outcomes: they can increase harm, have no effect on harm, decrease harm, or prevent harm. Since we are all terrified, it may be helpful to know the consequences our fear may have.

What We Can Learn from the Ebola Outbreak

The 2013-2016 West Africa Ebola Virus Disease (EVD) outbreak may be the best and most recent example of how to predict the effects of FRBs on COVID-19. 

More than 28,600 people became ill from Ebola in Guinea, Liberia, and Sierra Leone. Given the virus’ high mortality rate of nearly 40 percent, it caused approximately 11,300 deaths.  

Examining the behaviors and outcomes of EVD may portend the outcome of the COVID-19 pandemic if the FRBs we exhibit with the novel coronavirus are proportionately similar to those caused by Ebola outbreak.

There were five overarching consequences of FRBs during the EVD crisis:  

1. Fear accelerated the transmission of Ebola. Those who lived in infected areas tried to escape by traveling to places they perceived as less infected. In effect, they tried to outrun the infection, but that proved impossible. They carried the disease with them, infecting Ebola-free communities and increasing the number of deaths. Ignoring the risk would have the same effect in the United States. 

2. Fear — in combination with lack of resources — discouraged some of those who were infected from seeking care for their disease. They may have died from EVD unnecessarily. Those who are underinsured or lack insurance in the United States may also decline to seek care. 

3. The fear of being exposed to EVD prevented some people with other life-threatening diseases from getting the health care they needed. That may happen now, too. People who have heart disease, diabetes, immuno-suppressed cancer, or chronic pain may not seek medical treatment because they fear being exposed to the coronavirus through contact with healthcare providers or other patients. 

4. Fear of EVD increased the number of people with mental health disorders. Fear-induced stress may have caused trauma and exacerbated existing mental health problems. Also, survivors involved in providing care to the ill were often blamed for spreading the disease. Some may have suffered from survivor's guilt. Depression and other mental health disorders were common in survivors.  

5. The belief that specific countries were responsible for the origin and spread of EVD led to widespread discrimination and ostracism. This, in turn, caused serious social and economic consequences. We see that scenario play out again whenever someone calls the coronavirus the “Chinese virus.” 

Fear Can Increase or Mitigate Harm 

On the other hand, fear can also mitigate harm. In the case of COVID-19, the prospect of what may happen if we do nothing is overwhelming. Therefore, our fear may motivate us to protect ourselves and our families by adhering to the advice of experts in such health organizations as CDC and WHO. That may save lives. 

Consider your own behavior in light of the five FRBs described above. Ask yourself: 

• Could any of your avoidance or panicked behaviors be accelerating the transmission of COVID-19? 

• If you have symptoms that suggest you may have the coronavirus, are you in denial rather than seeking medical care? 

• If you are coping with other medical conditions, are you avoiding the doctor's office, or are you pursuing the health care you need? 

• If you are feeling overwhelmed by the fear and stress inherent in this situation, are you seeking support or professional help? 

• Do you acknowledge, and help others understand, that China, as the unfortunate initial vector of COVID-19, bears no responsibility for it and does not deserve to be our scapegoat?

In such an interconnected world, our individual responses determine our collective experience. We must not let fear make the crisis worse. Fear can help protect us, but it can also be our enemy.

We don't need another enemy. The virus is enough of an adversary for us to deal with. We must avoid giving fear undue power over our actions and judgment at such a critical time. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find Lynn on Twitter: @LynnRWebsterMD.

Opinions expressed are those of the author alone and do not reflect the views or policy of PRA Health Sciences.

AMA: Waive Limits on Opioids During Coronavirus Emergency

By Pat Anson, PNN Editor

The American Medical Association has released a new set of policy recommendations to help patients maintain access to opioids and other prescription drugs during the coronavirus pandemic. While many of the proposals involve substance abuse treatment, some are designed to protect chronic pain patients.

“These recommendations are to help guide policymakers reduce the stress being experienced by patients with an opioid use disorder (OUD) and pain as well as support efforts to continue harm reduction efforts in communities across the United States,” the AMA said in a statement.

The AMA is asking individual states to waive many of the requirements on filling prescriptions for opioids and other controlled substances during the coronavirus emergency.

• Waive limits on the dose and/or quantity of opioids and other controlled substances, as well as refills.

• Waive requirements for electronic prescribing of controlled substances, including requirements for an in-person evaluation of patients needing a refill.

• Waive drug testing and in-person counseling requirements for chronic pain patients needing refills.

• Allow for telehealth counseling to fulfill state prescribing and treatment requirements.

• Provide liability protection for physicians who prescribe controlled substances for patients the physician believes is compliant with prescription recommendations.

• Enhance home-delivery of medication for patients with chronic pain.

The AMA is recommending similar waivers for patients being treated for OUD, including the designation of addiction treatment drugs (buprenorphine, methadone, naltrexone) as “essential services,” allowing for 90-day prescriptions for buprenorphine, and suspending daily limits on residential and out-patient therapy.

The Drug Enforcement Administration recently waived federal requirements for in-person visits for controlled substance prescribing, allowing doctors and patients to connect remotely via telehealth. The AMA is encouraging states to take similar action for their own controlled substance regulations.