People With Chronic Pain Must Prepare for Coronavirus

By Dr. Lynn Webster, PNN Columnist

The new coronavirus, COVID-19, is real. It is not a political fabrication and it is not a hoax. Its dangers have not been exaggerated. With over 1,300 confirmed cases in the United States as I write this, we are now in the acceleration state of the pandemic.

In Italy, there were only three confirmed cases of coronavirus less than a month ago. Now there are over 12,000 cases and 827 deaths. The Italian government has ordered all shops, bars and restaurants to close, and a nationwide lockdown prevents 60 million people from traveling outside areas where they live.

What History Teaches Us About Pandemics

Although the trajectory of this coronavirus is difficult to predict, we can look at the history of other viruses to know what might happen in the U.S.  

Within a week or two, there will probably be tens of thousands of Americans who have the coronavirus. Most likely, the virus will remain a threat for at least a year. We almost certainly will not see a vaccine before then. By the time we have developed a vaccine, the virus will have infected millions of Americans and will probably have mutated in unpredictable ways.  

As I wrote in a previous column, the people with an increased risk for severe symptoms and possibly dying of COVID-19 are seniors and those with chronic illness. Of course, people in chronic pain are part of this high-risk group.  

The lethality of COVID-19 was initially reported to be about two percent, but the World Health Organization now estimates the overall fatality rate to be 3.4 percent. For people over age 60 or with underlying health problems, the rate is even higher. 

We still don't know how many people have been infected, so it is impossible to know the true rate of mortality (the number of deaths compared to the number of people diagnosed). As we improve our ability to test for the virus, hopefully we will see the rate of mortality decrease, although the number of deaths will continue to climb.  

The 1918 Spanish flu infected one-third of the world's population. Even though the pandemic lasted only 15 months, it still killed between 50 million and 100 million people worldwide. An estimated 670,000 of them were Americans. Adjusted for population growth, that would be more than 1.8 million Americans today.  

Just ten years ago, the H1N1 swine flu virus infected 60.8 million people worldwide. Up to half a million lived in the U.S. and 12,469 of them died. The swine flu spread slowly compared to coronavirus. In April 2009, a 10-year-old boy in California became the first American to test positive for the H1N1 virus. By October, President Obama had declared swine flu a national emergency.  

One of the takeaways of past pandemics is that we must recognize the speed at which a virus can spread and the importance of preparing as early as possible. 

It's Essential to Plan for the Coronavirus 

Every person in the United States should have a plan in place for dealing with the coronavirus. In the best-case scenario, our lives will be relatively unaffected. But we would be remiss to count on the best outcome. Wishful thinking won't help us. Preparedness may. 

One of my colleagues told me that during Hurricane Katrina, hundreds of patients in the Mississippi area with intrathecal delivery systems for conveying pain medications to the spinal canal were unable to be seen by their physicians. Many of the pumps ran dry during and after the hurricane because patients could not reach their doctors or the doctors could not obtain medications from the a compounding pharmacy. Patients experienced a tremendous increase in pain and many were forced into severe opioid withdrawal. 

Pain patients weren’t the only ones who suffered. Intra-abdominal pumps delivering insulin also ran dry. Thousands of patients experienced insulin withdrawal or diabetic coma. Many people with complex medical problems, including cancer, could not receive life-sustaining therapies. Some people died. 

Questions To Ask Your Doctor 

Think of COVID-19 as another natural disaster, and anticipate the same potential problems. Begin your planning immediately by talking with your doctor. Some of the questions to cover are: 

• In the event of widespread sickness and quarantines, will the doctor’s office be open?

• Can you get medicines delivered if you are not able to leave your home?

• What if your doctor is ill? Will they have someone who can fill in for them?

• How much medicine will you need to ride out a community-wide quarantine?  

Some experts recommend stockpiling additional medication in case of an emergency.  Ask your provider how they feel about that. 

How long can you last if there are supply problems and your doctor, nurse practitioner or pharmacist can't get your medication? What are your options? You may need to go to a different doctor. However, that can be problematic because fewer doctors are accepting new pain patients.

Also, if you do need to find another doctor, the prescription monitoring database may show that you have obtained medications from two or more different providers. You may be labeled as a doctor shopper. Ask your doctor how to avoid this problem. When meeting with your provider, be transparent about your concerns. Avoid panicking.

If you are infected, the virus may affect your ability to breathe. Opioids can add to breathing difficulties caused by viral infections, so be prepared to reduce the amount of your medication. Discuss with your doctor how to decrease your dose to remain safe.  

Be prepared to ask your doctor the right questions and come up with a plan together. Think of coronavirus as a serious threat, but trust that you can prepare to mitigate the harm.  

This is like war. But the invader is not a human enemy. It is an enemy of humans. It is an infection.

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.

Avoiding Coronavirus: Lessons Learned From People With Weak Immune Systems

By Anna Maria Barry-Jeter, Kaiser Health News

Andrea Amelse knows hand-washing.

For the past eight years, she’s been washing her hands pretty much every time she passes a sink. When she’s near a bottle of antibacterial gel, she uses it. She makes a point of avoiding people with contagious illnesses, even though it can be uncomfortable to ask to work from home or miss a date with friends. And she makes sure she gets plenty of sleep, not always easy at age 25.

Amelse was diagnosed in 2012 with lupus, an autoimmune disease that makes her vulnerable to infections. She’s since developed pulmonary arterial hypertension, a condition that requires intravenous therapy via a central line to her heart. Both illnesses place her at heightened risk for viral and bacterial illnesses. So, she has adapted as a matter of survival, taking to heart long-standing axioms on what constitutes good hygiene.

As the highly contagious new coronavirus continues its spread through the U.S., the general public could learn a thing or two from Amelse and the millions of other Americans with weakened immune systems who already live by rules of infection control.

Whether it’s people who had recent organ transplants, people undergoing chemotherapy or people with chronic diseases, America has a broad community of immunosuppressed residents who long ago adopted the lifestyle changes public officials now tout as a means of avoiding contagion: Wash your hands, and wash them often. Don’t touch your face. Avoid that handshake. Keep your distance from people who cough and sneeze.

Amelse doesn’t follow the advice perfectly — of course she touches her face sometimes.

“You do these things unknowingly, so forcing yourself to break these habits can be challenging,” she said. But the incentive to keep getting better is there. “If you get a cold and you give me that same cold, you might get it for a week. I’ll get it for a month.”

Even with her dedication, COVID-19 is proving a daunting prospect to face. And she has a stake in Americans adopting these habits because, while the disease is relatively minor for many people who get it, it can be life-threatening for people with preexisting conditions.

Amelse works at a health literacy startup in Minneapolis that helps patients with complicated diseases learn about their illness. She knows a lot about health and how to prevent infection. Still, the threat of COVID-19 is unnerving, for her and her doctors.

Stockpile Essential Supplies

With a virus so new, official guidance on what people at heightened risk should do to steer clear of COVID-19 is limited. But the Centers for Disease Control and Prevention recently said the virus seems to hit hardest in people 60 and older with underlying health concerns. There is also concern for younger people with limited immune systems or complex diseases.

Health officials are asking those at risk to stockpile two-week supplies of essential groceries and medicines in case they need to shelter at home; to avoid crowds and heavily trafficked areas; to defer nonessential travel; and to track what’s going on in their community, so they know how strictly to follow this advice.

Infection control always follows a similar set of principles, said Dr. Jay Fishman, director of the Transplant Infectious Disease and Compromised Host Program at Massachusetts General Hospital and a professor at Harvard Medical School. The most important things for people to do right now are the things he always recommends to his organ transplant and cancer patients. Again, think hand-washing and avoiding spaces where sick people congregate.

Still, the recommendations aren’t one-size-fits-all. Some people are born with stronger immune systems, and immune deficits exist on a spectrum, said Fishman. How strict people need to be to prevent illness can vary depending on how susceptible they are.

Avoid Crowds

Recommendations also need to take into account what people can and will do, he said. Children, for example, are among the greatest germ vectors of all time, but Fishman doesn’t ask his patients with grandchildren to stay away from their young family members. “We did the transplant so you can see your grandchildren,” he might tell them.

Similarly, avoiding crowds and staying away from sick people is easy for some but can be all but impossible if you work in food service, for example. Find ways to avoid the risks and reduce them where possible.

Though there isn’t great research on how well transplant patients and others manage to prevent infection, Fishman said many of his patients don’t get sick any more frequently than the general population, despite their vulnerabilities. But when they do, the illnesses tend to last longer, be more severe and put people at higher risk for additional infections. He counsels patients to be vigilant, but also to live their lives and not be ruled by fear.

Dr. Deborah Adey, a transplant nephrologist for UCSF Health, echoed Fishman, saying she likes to find ways to help her patients carry on with their lives. A patient recently asked if it was OK to fly to Salt Lake City, and she suggested they drive instead.

Gauging the risks can be tough. Amelse was relieved when a major health conference she was scheduled to attend recently in Florida was canceled at the last minute. She wasn’t sure it was safe to travel, but it also was unclear how to categorize an important work trip: Was this essential? Nonessential?

Adey conducts follow-up appointments via teleconferencing where possible, to keep her patients out of medical facilities. Hospitals are, by design, places for the sick, and people with compromised immune systems are generally advised to avoid them and the viruses and bacteria potentially inside.

That matches advice from officials in California and other states, asking people to stay out of emergency rooms unless absolutely necessary. They are asking people, when possible, to call ahead to their doctors and stay home unless an illness is serious.

Good Hygiene

And, similar to what public officials are advising the general population, Adey does not recommend that her patients wear face masks when out in public or even at the clinic. “The only people I would recommend is if they’ve got a lot of close contact with the general public, and they can’t afford to be off work.”

While much has been made of the hoarding sprees for face masks, the empty hand sanitizer shelves are equally frustrating for Amelse. Every 48 hours, she has to mix and administer drugs she places in an IV that goes into her heart. Everything must be sanitized, and she typically gets monthly shipments of antibacterial wipes and sanitizer. If suppliers run out, she’s worried she’ll have to go to a hospital to have the drugs administered — exactly where her doctors don’t want her to be.

Officials are desperately working on a vaccine for the coronavirus for use in as little as 12 to 18 months. But many vaccines are made from live viruses and can’t be given to some immunosuppressed people.

Given the risk COVID-19 poses for people with compromised immune systems, the government needs to stress how important it is for everyone to follow good hygiene protocols, said Fishman. “The worst thing we can do is downplay it.”

And for those just getting up to speed on preventing infections, Amelse has advice: “Viruses don’t pick and choose; they will latch on anywhere,” she said. Even if it’s not a serious illness for you, “there are people in your life that you can infect. You have the obligation and the responsibility to take care of your loved ones.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation, which is not affiliated with Kaiser Permanente. This story was first published on California Healthline, a service of the California Health Care Foundation.

Tweet Led to Dr. Kline Losing His DEA License

By Pat Anson, PNN Editor

A complaint from a woman in upstate New York launched the investigation that recently led to a North Carolina doctor losing his DEA license. Julie Roy doesn’t know Dr. Thomas Kline or any of his patients, but claimed he was dangerous and that “someone can die” because Kline believes opioids are rarely addictive.

Kline surrendered his DEA license to investigators with the North Carolina Medical Board last month.  He is still able to practice medicine but can no longer prescribe opioids and other controlled substances, leaving his 34 patients in medical limbo. All of them suffer from chronic pain and rare diseases that other doctors are increasingly unwilling to treat because they fear coming under scrutiny for opioid prescribing

“I do feel bad for the patients that were affected,” Roy told North Carolina Health News, which first reported on her role in the Kline investigation.

Roy became upset with Kline because he has been an outspoken advocate for pain patients online. Roy’s 26-year old son died from a heroin overdose and she took offense when Kline posted a Tweet last year stating that “opiates work fine without addiction potential” in 99.5% of people.    

She tweeted the North Carolina Medical Board on May 15, saying “this is a doctor that you allow to have an active license. He would love to prescribe every person on earth an opioid.”

NORTH CAROLINA HEALTH NEWS

That same day, Roy made a formal complaint with the medical board against Kline, making a series of unsubstantiated claims about the doctor.

“He is giving out information regarding opioids that is not correct and could cause harm,” she wrote. “I am very concerned as pain patients believe what he says. He says opioids are only addictive to someone who is genetically prone plus a ton of other misinformation.”

Roy even claimed that Kline might be “suffering from substance use disorder himself.”

“The man should not have an active license with his pro opioid perception. The information he puts out alone could cause harm. I would like you to verify (t)hat he is not writing opioid prescription,” Roy wrote.  

Kline Caught Off Guard

Kline responded in writing to Roy’s complaint in July, telling the medical board the information he shared about opioids was accurate and backed up by research. He also denied taking opioids or having a substance use disorder.

“Ms. Roy has lost a son to opiate addiction. Losing a child is the worst of all tragedies. This tragedy could have been avoided with the new knowledge I am presenting in my published research and public talks urging for early identification and treatment of opiate addiction to stop deaths in people like Ms. Roy’s son,” Kline said.

Because none of his patients were harmed by his prescribing and no other complaints were filed against him, Kline thought that would be the end of the matter – even when the medical board asked to review the records of nine of his patients.

Kline was caught off guard when investigators made a surprise visit to his office in Raleigh on February 17 and told him to surrender his DEA license. He did so voluntarily, not realizing at the time that it was unlikely he’d ever get the license back.  

No formal charges have been made against Kline and the medical board won’t comment on the status of the investigation — which could drag on for several more months.

Kline says he’s been able to find new doctors for a handful of his patients, but others are suffering due to untreated pain or running low on their prescriptions.

Ironically, Roy was once a pain patient herself and was on long-term opioid therapy after a failed back surgery. She told NC Health News that her pain medication stopped working, so she switched to buprenorphine (Suboxone), another opioid that’s usually prescribed to treat addiction.

Should Gabapentin Be Used to Treat Alcohol Abuse?

By Pat Anson, PNN Editor

Gabapentin (Neurontin) is so widely prescribed for so many different conditions that a Pfizer executive infamously compared it to “snake oil” in a 1999 email.

“Gabapentin is the snake oil of the twentieth century. It has been successful in just about everything they have studied,” said Christopher Wohlberg, who was a Pfizer Medical Director at the time.

Although only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, gabapentin is widely prescribed off-label to treat fibromyalgia, anxiety, depression, ADHD, migraine, bipolar disorder, restless leg syndrome and a growing number of other conditions.  

Already the 6th most widely prescribed drug in the United States, gabapentin is also being touted as a treatment for alcohol abuse.

In a small study published in JAMA Internal Medicine, researchers found that gabapentin was effective in treating patients with alcohol use disorder (AUD) – problem drinking that has become severe. Compared to a placebo, gabapentin significantly increased abstinence and reduced heavy drinking days, especially for those who suffer from symptoms of alcohol withdrawal.

“The weight of the evidence now suggests that gabapentin might be most efficacious after the initiation of abstinence to sustain it and that it might work best in those with a history of more severe alcohol withdrawal symptoms,” concluded lead author Raymond Anton, MD, an addiction psychiatrist and professor at the Medical University of South Carolina.

“Armed with this knowledge, clinicians may have another alternative when choosing a medication to treat AUD and thereby encourage more patient participation in treatment with enhanced expectation of success.”

As many as 30 million Americans have AUD, but only about a million are taking a medication to help them reduce drinking or maintain abstinence. The FDA has approved three drugs (naltrexone, disulfiram and acamprosate) for the treatment of alcohol abuse.

Side Effects and Abuse

The suggestion that gabapentin should also be prescribed for AUD comes at a time when the drug is already under scrutiny for its abuse and side effects, including an association with a growing number of suicide attempts. Patients prescribed gabapentin often complain of mood swings, depression, dizziness, fatigue and drowsiness.    

Although the CDC’s controversial 2016 opioid guideline calls gabapentin and its chemical cousin pregabalin “first-line drugs” for neuropathic pain, a recent clinical review found little evidence that either drug should be used off-label to treat pain.

Gabapentin does not carry the same risk of addiction and overdose as opioid pain relievers, but illicit drug users have discovered that gabapentin can heighten euphoria caused by heroin and other illicit opioids. Should a drug like that be used to treat addiction?

Hundreds of clinical studies are underway to find new uses for gabapentin, not only for alcohol abuse, but for a cornucopia of conditions such as obesity, insomnia, breast cancer, asthma, menopause and overactive bladder. One recent study even found that gabapentin improves sexual desire in women with vulvodynia.

Instead of finding new uses for an old medication, maybe it’s time to come up with a new drug.

Americans at High Risk From Coronavirus Urged to Stay Home

By Pat Anson, PNN Editor

A senior U.S. health official warned Sunday that Americans with underlying health conditions should avoid large crowds and not board airplanes or cruise ships because of the coronavirus outbreak. Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, also said quarantines of infected areas in the U.S. may become necessary.

"It's possible," Fauci told host Chris Wallace on Fox News Sunday. "You don't want to alarm people, but given the spread we've seen, anything is possible, and that’s the reason we have got to be prepared to take whatever action is appropriate to contain and mitigate the outbreak."

Italy’s Prime Minister on Sunday ordered a quarantine of northern Italy, after a spike of over a thousand new coronavirus cases was reported.  Italy has recorded nearly 6,000 cases and 233 deaths, the most fatalities outside of mainland China. About 16 million people live inside the quarantine area.

"We have to be realistic," said Fauci, when asked if similar travel bans could be imposed in the U.S. "I don't think it would be as draconian as nobody in and nobody out, but if we continue to get cases like this, particularly at the community level, there will be what we call mitigation, when you'll have to do essentially social distancing: keep people out of crowded places, take a look at seriousness -- do you really need to travel? And I think it particularly important among the most vulnerable.”

Fauci says elderly people with heart disease, chronic lung disease and diabetes should avoid high-risk situations, such “crowded places, getting on airplanes, and absolutely don’t get on a cruise ship.”

‘You’re Going to See More Deaths’

The comments from Fauci and other leading health officials signaled the U.S. was shifting from a failed effort to contain the virus to mitigation, such as closing schools and cancelling large gatherings.

"Initially, we had a posture of containment so that we could give people time to prepare for where we are right now. We're shifting into a mitigation phase, which means that we're helping communities understand you're going to see more cases. Unfortunately, you're going to see more deaths. But that doesn't mean that we should panic," U.S. Surgeon General Jerome Adams said CNN's State of the Union.

“We have to implement broad mitigation strategies. The next two weeks are really going to change the complexion in this country. We’ll get through this, but it’s going to be a hard period. We’re looking at two months, probably, of difficulty,” Dr. Scott Gottlieb, former commissioner of the Food and Drug Administration said on CBS’ Face the Nation.

As of today, there are 21 deaths and 521 confirmed cases of coronavirus in at least 33 states, although the actual number is likely to be higher because testing for the virus in the U.S. has been limited. There are over 109,000 cases worldwide and 3,799 deaths.

Early information out of China suggested the chances of a coronavirus patient dying were about 2.3 percent. But last week the World Health Organization raised the fatality rate to 3.4 percent, which is far higher than seasonal flu, which kills about 0.1% of those infected.

While symptoms are mild for most coronavirus patients, the elderly and those with chronic health conditions are most at risk. A study done by the Chinese Center for Disease Control and Prevention found that people over the age of 80 have the highest fatality rate of all age groups at 14.8 percent, followed by people in their seventies (8%) and sixties (3.6%).

People with the following health conditions also have a higher risk of dying:

• 10.5% Cardiovascular disease

•   7.3% Diabetes

•   6.3% Chronic respiratory disease

•   6.0% Hypertension

•   5.6% Cancer    

According to the CDC, people at higher risk from the COVID-19 virus should stay home and “avoid crowds as much as possible.”

Dangerous New Street Drug Found in Counterfeit Painkillers

By Pat Anson, PNN Editor

A dangerous new street drug that’s even stronger than fentanyl has been found in counterfeit opioid painkillers seized during a police raid on Canada’s eastern seaboard.

Like fentanyl, isotonitazene is a potent synthetic opioid that is many times stronger than heroin or morphine. In recent months, isotonitazene was detected in over a dozen overdose deaths in Illinois and Indiana, where it was mixed with cocaine. The drug has also recently been found in New Brunswick and Alberta, and has been connected to at least two overdose deaths in Calgary.

Now it is being used to make counterfeit pain medication.

Police in Halifax, Nova Scotia seized 1,900 white tablets from a Halifax home last month while conducting a drug investigation. The pills were sent to Health Canada for a laboratory analysis, which confirmed the tablets were made with isotonitazene.

The pills have an “M” on one side and the number “8” on the other side – making them virtually identical to an 8mg Dilaudid (hydromorphone) tablet.

SOURCE: HALIFAX POLICE

“The appearance of the pill may lead people to believe they are consuming a different drug. Given the potency of the drug, a person may need several doses of naloxone to counter an overdose caused by isotonitazene,” Halifax police said in a statement.

No overdoses have been linked to isotonitazene in Halifax, but police are urging anyone who consumes the pills to seek immediate medical attention.

The Center for Forensic Science Research and Education released a public safety alert last November, when isotonitazene was first linked to overdoses deaths in the Midwest.

“Pharmacological data suggest that this group of synthetic opioids have potency similar to or greater than fentanyl based on their structural modifications,” the alert warns. “The toxicity of isotonitazene has not been extensively studied but recent association with drug user death leads professionals to believe this new synthetic opioid retains the potential to cause widespread harm and is of public health concern.”

Although law enforcement and public health officials have only recently become aware of the threat posed by isotonitazene, illicit drug users have been warning each other about isotonitazene for several months in online message boards.

“I wanted to let the community know that the potency is far above the 60x morphine that's listed online. Everyone should be VERY careful when handling this compound,” one poster warned on Reddit.

Being Taken Off Methadone Is Inhumane

By Wendy Cooper, Guest Columnist

I am a pain patient and diabetic entering my second week of detox.  My doctor will no longer prescribe methadone because he’s afraid of being targeted by the DEA for not following the “voluntary” CDC guideline.  He said they are putting doctors in prison by the hundreds and it’s just no longer worth the risk. 

I was on methadone for years.  I am also a gastric bypass patient, so I will not be able to take any type of NSAID (non-steroidal anti-inflammatory drug) for pain. 

When my doctor first suggested methadone I was totally confused.  I told him, “But wait, that’s for drug addicts.”  Well it is, but it’s also very effective for pain control.  After taking it for a month I was so happy.  It totally handled my pain and I didn’t have all of the other side effects, like making me sleepy and lethargic.  My mind was clear. I had my life back.  Yes, for many methadone works.  Sadly, it used to work for me, too.  

I am now back on insulin every day due to the pain, after having been off of insulin for years. Methadone did that.  It started the ball rolling in a positive direction. I was able to exercise more and take care of my family, because the pain relief helped get my diabetes under control. Not anymore. 

Supposedly the danger is because methadone, which has been around for over 50 years, has an effect on the respiratory system.  Well, this is true of many medications if they are not taken correctly.  If I take too much of my insulin, it will have an effect on my respiratory system too — as in me not breathing at all because I will be dead. 

Tons of medications have dangerous side effects if not taken properly.  What used to happen is you would weigh the benefits and the risks with your physician and then the patient would make an informed decision. 

WENDY COOPER

Why does the government have the right to take away medication that has changed my life for the better?  Why am I being treated like a child by assuming I will not take my medication correctly?  I can’t think of any valid reason for this except MONEY.  Methadone is $35 per month, while buprenorphine (Suboxone) is close to $300. 

Buprenorphine is not a good fit for pain patients.  We are much more likely to go to the emergency room for an acute event than non-pain patients.  What will they give us for pain? 

It’s my understanding that pain medications are complicated when you are facing surgeries while on buprenorphine.  I have four surgeries scheduled this year.  Am I supposed to wean myself every time I get ready for one of my surgeries? 

I always felt safer from any type of addiction issue because methadone took away the “feel good” effects of Percocet.  If I hurt myself, I could take a Percocet and it would help with the additional pain. 

I don’t have an addiction problem, but like most pain patients I am concerned about developing one. I’ve always felt it is my responsibility to take precautions and govern myself with my own guidelines.  Well, that benefit is gone.  I don’t want to live anymore. This is inhumane. 

Wendy Cooper lives in Florida.

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

Canada’s Chronic Pain Task Force Surveying Patients

By Marvin Ross, Guest Columnist 

In typical government fashion, the Canadian Chronic Pain Task Force continues to delay taking a stand on the plight of pain patients by initiating a new survey, while still blaming doctors and patients for the opioid crisis. 

The Task Force was established last year to help Health Canada better understand the needs of chronic pain patients. Their preliminary report in June found that anxiety and fear about opioids were causing pain to go untreated:

“Some Canadians have been unable to access opioid medications when needed for pain and function. Others have faced undue barriers to obtaining or filling their opioid prescriptions, and some have had their opioid dose abruptly lowered or discontinued. This has resulted in unnecessary pain and suffering, and has led some Canadians to obtain illegal drugs to treat their pain. We must do more to strike the right balance – to promote opioid prescribing practices that balance the benefits and risks of these medications based on the individual needs of each patient.”

Those initial findings were consistent with the results of a survey of over 700 pain patients conducted by the Chronic Pain Association of Canada (CPAC). That survey found that nearly half of Canadian patients had their pain medication reduced, many were in much greater pain, had severely diminished quality of life, lost doctors or had poor relations with them, attempted suicide or turned to street drugs for help.

At that point, the Task Force response should have been to make recommendations to reverse those negative impacts on patients. Two evaluations that replicate each other should be sufficient to take action to relieve the suffering caused by Canada’s 2017 opioid prescribing guideline.

But that is apparently asking too much as they've decided to do another survey through invitations to their online questionnaire. These are the key questions: 

• What challenges and barriers to understanding, preventing, or managing pain exist in your community and in Canada?  

• What needs to be done to respond to these challenges and barriers? 

• What is working to address pain in your community and in Canada? Please provide specific examples of practices and/or activities. 

• What is it about these practices/activities that makes them successful?  

• What should be the 3 top priorities for research in pain from your point of view?  

• What would help to better integrate research and new knowledge into education and training, policy, clinical practice, and everyday life?  

• What other strategies would help us to better understand, prevent, and/or manage pain in Canada?

Well, the main barrier to managing pain is the adherence by doctors to the prescribing guideline and their fear of losing their medical licenses if they don’t. Nothing will restore functioning to those impacted without rescinding that. The rest of the questions are inane. 

Where Is the Evidence?

As I pointed out in an earlier PNN article, Health Canada implemented the guideline based on weak evidence that the increase in opioid deaths result from inappropriate prescribing by doctors and misuse by patients. PNN columnist Ann Marie Gaudon attempted to obtain the research that Health Canada used to justify their claims and it was like pulling teeth, as you’ll see in this phone call. 

When the research was finally obtained, it didn’t prove a link between prescribing and overdoses. When CPAC sent them a critique of their studies, Health Canada replied that they have much more evidence, but then ignored requests for copies. CPAC has submitted a Freedom of Information request and is waiting for a response. 

Health Canada and the Chronic Pain Task Force continue to base their work on the many myths and misperceptions associated with opioid prescribing, which were debunked in a review recently published in Pain Management Nursing.  

A policy based on faulty logic to solve a problem (addiction and opioid overdoses) caused a new problem by condemning innocent people to unnecessary pain and suffering. Meanwhile, the original problem only grows worse. It is time to go back to the drawing board and accept what every Sociology 101 student knows. There are unintended consequences. Until that happens, nothing will be improved for anyone.   

But then, to make matters worse, this week Health Canada announced nearly $3 million in funding “to help people living with chronic pain.” Most of the money will apparently be spent on treating and preventing addiction, not treating pain. Saskatchewan will get $1.7 million from the Substance Use and Addictions Program and Alberta will get $1.2 million to “improve care delivery including opioid prescribing practices.” 

Health Canada does not seem to be able to distinguish between people with chronic pain and those with substance abuse problems. They are not the same and it is insulting to combine them. It is time that Health Canada learned to distinguish between dependence and addiction. 

Marvin Ross is a medical writer and publisher in Dundas, Ontario.

DEA Warns Doctors About Extortion Scam

By Pat Anson, PNN Editor

It’s no secret that doctors are under increased scrutiny from the Drug Enforcement Administration and other law enforcement agencies for their opioid prescribing practices.

Last month a North Carolina physician was told to surrender his DEA license by investigators with the state medical board. “They called me on the phone and said they were coming by in two hours to get you to surrender your license,” Dr. Thomas Kline told PNN.

In southern California, a doctor who recently paid a $125,000 fine to settle allegations of illegal opioid prescribing says federal prosecutors threatened to ruin his practice and reputation if he didn’t pay up.

“They could care less if I was innocent or guilty. They wanted to see how much they could gouge out of me,” said Dr. Roger Kasendorf, an osteopathic physician in La Jolla. “It was extortion and there’s nothing I was able to do about it. It’s sad and pathetic.”

It didn’t take long for criminals to realize that other doctors could be vulnerable to extortion. And with no small amount of irony, the DEA’s San Diego Field Division recently issued an unusual alert warning doctors about scam telephone calls from con artists posing as DEA agents, who threaten physicians with arrest and prosecution for violations of federal drug laws.

“DEA continues to receive reports of calls threatening legal action if an exorbitant fine is not paid immediately over the phone. The callers identify themselves as DEA personnel and instruct their victims to pay the ‘fine’ via wire transfer to avoid arrest, prosecution and imprisonment,” the DEA alert warns.

The scam artists – who use fake names, DEA badge numbers or even the actual names of senior DEA officials – threaten to revoke DEA licenses if thousands of dollars are not paid by wire or in untraceable gift cards.

The threat is not an idle one, because doctors cannot prescribe opioid medication and other controlled substances without an active DEA license.

“DEA employees do not contact practitioners or members of the public by telephone to demand money or any other form of payment,” the DEA said. “Notification of a legitimate DEA investigation or legal action is made via official letter or in person.”

The alert urges anyone receiving a telephone call from a person claiming to be a DEA employee demanding money to report the threat using DEA’s online form or by calling 877-792-2873.

Stem Cell Trial Significantly Reduced Osteoarthritis Knee Pain

By A. Rahman Ford, PNN Columnist

A small clinical trial has shown that a single injection of autologous stem cells derived from a patient’s own body fat can significantly reduce osteoarthritis knee pain for up to a year with no serious side effects, according to findings published in the American Journal of Sports Medicine.

A total of 39 osteoarthritis patients participated in the Phase 2 placebo-controlled trial. Some participants received injections into their knees of stromal vascular fraction (SVF) cells derived from adipose fat tissue, while others received placebo injections.

"Our randomized, controlled clinical trial is the first cellular therapy study for osteoarthritis to meet study endpoints using autologous adipose stromal cells for a point-of-care therapy. Eighty-eight percent of subjects responded greater than placebo at one year and reported a median 87% improvement in pain, stiffness and function," said William Cimino, PhD, CEO of GID BIO, which funded the study. GID BIO develops cellular therapies for degenerative musculoskeletal, dermal and other chronic diseases.

SVF therapy is controversial because it is not yet FDA-approved. Some stem cell clinics currently using SVF therapy are in the crosshairs of the FDA, with ongoing federal litigation in Florida and California. That’s what makes the new study findings significant.

"Publishing this data signifies real science and a breakthrough in regenerative medicine. We've completed a prior safety trial, an FDA-approved Phase 2b trial, and are now beginning a Phase 3 pivotal trial. Physicians will be able to use the SVF-2 technology to provide a cellular therapy option for patients," said principal investigator Jaime Garza, MD, Professor of Orthopedic Surgery at Tulane University School of Medicine.

Interestingly, Garza is a former star football player at Tulane whose fledgling NFL career was cut short by nagging knee injuries. As PNN has reported, regenerative cell therapies are increasing in popularity among NFL players and other professional athletes, who often have chronic pain from lingering injuries.

Knee osteoarthritis (OA) is the most prevalent joint disease in the United States, affecting nearly 1 in 5 Americans aged 45 years and older. Since the mid-20th century, knee OA has doubled in prevalence, due primarily to age and obesity. Women are more likely than men to have knee OA and have more severe pain.

Total knee arthroplasty – a procedure that attempts to restore function by resurfacing the knee joint – is the only surgical intervention for knee OA. Other treatments include anti-inflammatory medications, physical therapy and steroid injections.  The FDA is also considering a new drug application for tanezumab, a biologic drug that blocks pain signals from reaching the brain.

“While current nonoperative modalities can offer symptomatic relief, these treatment modalities often fail, ultimately leading to knee arthroplasty. There is a need for more effective nonoperative knee OA treatment modalities, especially ones that may arrest or even reverse disease progression,” wrote Garza.

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.

11 Myths About the Opioid Epidemic

By Pat Anson, PNN Editor

If you’re a journalist, researcher or student interested in learning more about the opioid epidemic – or a patient or healthcare provider just trying to make sense of it -- a revealing new analysis debunks many of the myths and falsehoods being told about opioid pain medication.

“Misperceptions about the Opioid Epidemic: Exploring the Facts” was recently published in the journal Pain Management Nursing. Unlike most articles in medical journals, this one is not hidden behind a paywall – so the comprehensive and heavily footnoted research is available to everyone for free.

Co-authors Cathy Carlson, PhD, a professor at Northern Illinois School of Nursing, and June Oliver, APRN, a clinical nurse pain specialist at Swedish Covenant Hospital in Chicago, worked on the article for over four years, compiling research on 11 common myths about opioids that are repeated ad nauseam by the media, politicians, law enforcement and others.   

“We identified many more than this, but you have to put a limit on how long an article can be, so we narrowed them down to what we thought were the most important ones,” Carlson told PNN. “What concerned us is that this is all being presented by politicians and other important entities. It's just perpetuating the fear and sensationalizing it.”

Misperception #1 is the number of deaths attributed to opioid medication. The next time you see a statistic reported like “more than 63,600 people died of drug overdoses” in 2017, you should recognize that thousands of deaths were counted multiple times.  That’s because the Centers for Disease Control and Prevention doesn’t count “deaths” – it counts the number of drugs involved in overdose deaths.

The actual number of Americans who died from opioid overdoses in 2017 was not 63,000 – but about 49,000.

“If a person died of fentanyl, heroin and prescription opioids, that’s three deaths. We went from one person that actually died to three deaths counted in the categories because they put one under each,” explained Carlson. “It’s never known which drug they actually died from. So, we can never say prescription opioids caused the death. We can only say they were present at the time of death.”

Another myth is that more Americans die from opioid overdoses than in motor vehicle accidents, a claim first made by the National Safety Council (NSC) that’s been widely repeated in the media.  

“The opioid crisis in the United States has become so grim that Americans are now likelier to die of an overdose than in a vehicle crash,” The New York Times reported.

Carlson and Oliver say the NSC used a “confusing mismatch of statistical categories” to inflate the overdose numbers and make them more “attention grabbing.”

What are the actual facts? Nearly 30,000 Americans died in motor vehicle accidents in 2014, but the number of prescription opioid deaths was about half that.

“It doesn’t make as good of a story if you include it. We do believe it is purposely misleading,” says Carlson. “It’s the change theory. They have this need for change and they’re supplying it with statistics that sensationalize the issue.”

CDC’s Anti-Opioid Bias

Some of the other myths debunked by Carlson and Oliver include claims that the U.S. is the biggest consumer of opioids; that long-term use of opioid medication is not supported by evidence; that prescription opioids often lead to heroin use; and that statistics published by CDC are of high quality.

“We have a lot of issues with data collection. It’s not the CDC’s fault, they can only use what’s given to them. And states vary considerably in their accuracy in keeping statistics for overdose deaths,” Carlson said. “We’d like to see better data collection, especially through state and county medical examiners, so the statistics reported by the CDC are more accurate.”

But the CDC is not held blameless for the cascade of misinformation. Carlson says the agency has an anti-opioid bias that is repeated in many of its studies and policy statements.

“If you read what they do publish, they obviously have a viewpoint. It’s not a neutral viewpoint that gives you both good and bad. They are pushing you in a certain direction,” she said.

The CDC’s controversial 2016 opioid guideline – intended only for primary care physicians treating non-cancer pain – has been implemented as policy or law in dozens of states.

“I’m disappointed in what has occurred with CDC guidelines. Many people question the guidelines and that they weren’t always based on evidence,” Carlson said. “They were meant for primary care providers, not for pain management specialists, not for surgeons, and they’re making them apply to everyone. They are supposed to be guidelines. There are always people out on the Bell Curve and they don’t take that into consideration either.”

Carlson says Americans should be cautiously skeptical about much of the information they’re getting about the opioid crisis.  

“We’re mostly asking for discernment. To be aware of what you’re reading,” she said. “We want you to think about these statistics and look at the glaring gaps and reporting of statistics.”

FDA Reviewing New Osteoarthritis Drug

By Pat Anson, PNN Editor

A decade long effort to bring a new non-opioid pain reliever on the market is a step closer to reality – although lingering questions remain over the safety of the drug.

Pfizer and Eli Lilly have announced that the U.S. Food and Drug Administration has accepted for review a Biologics License Application for tanezumab as a treatment of chronic pain due to moderate-to-severe osteoarthritis (OA). The FDA set December 2020 as a goal for making a decision on the application.

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body because of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from muscles, skin and organs from reaching the brain.

"The FDA acceptance of the tanezumab application represents a significant milestone, and the breadth of our regulatory submission reflects the extensive clinical data we have gathered for tanezumab over the course of its development," Ken Verburg, Pfizer’s tanezumab development team leader, said in a statement.

"There is an urgent need for innovation in the treatment of osteoarthritis, as there have been no new classes of medicines available for this debilitating condition in more than a decade. If approved, tanezumab would be a first-in-class treatment for patients suffering from chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate pain relief with other analgesics."

Pfizer and Eli Lilly are jointly developing tanezumab, which was given “fast track” designation by the FDA in 2017 to help speed its development. The companies submitted data to the FDA from 39 clinical studies evaluating the safety and efficacy of tanezumab on more than 18,000 patients.

A Phase 3 clinical study in 2018 found that osteoarthritis patients who were given two injections of tanezumab had significant improvement in their pain and physical function compared to a placebo.

Not all of the studies have been positive, however. Another Phase 3 study last year found that over 6% of osteoarthritis patients taking a 5 mg dose of tanezumab experienced rapidly progressive OA in their joints. There was significant improvement in their pain and physical function, but the patients’ overall assessment of their condition was no better than those treated with non-steroidal anti-inflammatory drugs (NSAIDs).

Patients in the same study taking a lower 2.5 mg dose of tanezumab did not have any significant improvement in their pain, quality of life or overall condition. And 3.2% experienced rapidly progressive osteoarthritis. The license application accepted by the FDA is for that smaller 2.5 mg dose.

In 2010, Pfizer reported some osteoarthritis patients taking tanezumab experienced worsening of their disease and needed joint replacements. Another safety issue arose in 2012 because the drug caused “adverse changes in the sympathetic nervous system of mature animals.”

There is some concern that NGF antibodies work too well and encourage osteoarthritis patients to become more active, which accelerates joint deterioration. More than 27 million Americans live with osteoarthritis, 11 million of whom have moderate-to-severe OA.

Tanezumab is also being evaluated as a treatment for cancer pain due to bone metastases in a Phase 3 study. At one time, it was studied as a possible treatment for low back pain, but Pfizer and Eli Lilly are now mainly focused on tanezumab as a treatment for osteoarthritis.

A Toxic Violation

By Mia Maysack, PNN Columnist

On Saturday, I woke up to an experience far too common.

A column I wrote on my pursuit of holistic health had been shared in an online community for people with pain and chronic illness. The column was referred to as "shameful” and full of "bull crap." I was accused of being "insane,” a "bootstrap ableist" and “spreading hysteria.” You get the idea.

This type of toxic negativity online is mostly faceless and comes from hiding behind the comfort of a device screen. It doesn't belong in a supposedly safe space, nor does it help or improve anything. Even on my worst, most painful, dark and isolating days, I never have nor will I use that as an excuse to tear others down. 

Some people in the pain community claim to desire understanding, acceptance, empathy and compassion -- all the while offering anything but.

So many also demand change without the realization they’re contributing to the very problems they claim to want to resolve. It would seem the only fingers being lifted are to spread hate -- as opposed to directing that same passion toward legislative reform, writing a bill, calling Congress or signing a petition, for example.   

If we're not physically healthy enough to contribute fully to life, then bullying should be the last thing we’ve got the energy and time for.   

This takes me back to the very first (and last) "support group” I attempted to be a part of prior to starting my own. It’s prestigious, well known and in cahoots with many other affiliations.

Because I'm not spiteful and feel there's already enough hurt to go around, I won’t name or put them down.

In that group are thousands of people from around the world who could attest to the way I felt all my life. I hoped that that I’d finally came across a place where I belonged.

But when confiding to these people about a treatment plan gone awry (I still live with the repercussions to this day), they turned on me -- claimed I was just attempting to scare them, making things up, and that I should've kept the information to myself. Even my medical background was called into question, despite the grief I was still enduring over loss of career.

To make matters worse, prior to me even seeing any of this, the group’s administrators muted further commentary so I wasn't even able to defend myself or the way my words had been twisted. But they still left it there as a spectacle for all to see. It struck me to the core for multiple reasons, so I ultimately chose to step away and haven't looked back. 

Those of us who have come to a point of using our last bit of energy to reach out cannot afford being pushed off the ledge we are already on. The fact that isn't being contemplated or taken into any consideration is a sickness in itself. This toxic negativity is real and may be why my approach is internalized by others at times, even though that's not the whole picture of who I am.

How I live with multiple intractable, lifelong and incurable diseases is by continuing to study and having an intimate relationship with science via my own body chemistry.   

Whether it's a convenient truth or not, there's merit to the parasympathetic system. There’s power in working through trauma, taking ownership over our thoughts, approaching ourselves as a whole person and not allowing the conditions themselves to dictate our identity.

I've often been asked how I am able to live my life under the scrutiny of what I go through.  I don’t claim that I’m fixed, cured or have anything close to all of the answers. But I do know that instead of complaining, wallowing, and holding onto anger and resentment -- I choose to not allow this to define me.  My heart is poured into service, volunteerism and fighting for human rights -- for everybody, even those who throw dirt on my name. 

We are not wrong for how we feel. It's reactionary to lash out or play the blame game by turning on each other. It only intensifies the battle we're already in. Just because someone else's journey looks different and doesn't align with yours does not excuse, justify or make it acceptable to judge, ridicule or belittle them.

As long as those toxic violations remain a part of our approach to ourselves and one another, we shall remain sick.  

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 People Keep Their Leftover Rx Opioids

By Dr. Lynn Webster, PNN Columnist

"Who Is Keeping Their Unused Opioids and Why?"

That’s an important question, especially since we're currently in the midst of a drug crisis. The last thing we want is more prescription drugs being diverted onto the street and circulated for non-medical use. The issue was the subject of a research article published last year in Pain Medicine.

The authors surveyed 235 patients who received hydrocodone prescriptions following emergency room visits between July 2015 and August 2017. All were given information about how to safely dispose of their unused hydrocodone. Researchers contacted the patients a month after they were discharged, asking what they planned on doing with their leftover pills. 

Over half said they had no intention of giving them up. Only 100 of the 235 said they would follow advice and dispose of their unused medication.  

When asked why they were keeping their leftover pills, patients said it was “in case I have pain,” “just in case” and “You never know. If I need it [when I'm traveling out of the country], I can use it.”

A larger national study conducted in 2015 had similar findings. Over 60 percent of patients prescribed opioids said they planned on keeping their leftover pills for future use.

Policy Changes May Be Making the Problem Worse

Over the past several years, partly in an effort to decrease the number of unused opioids, there has been a sweeping change in attitudes and practices of dispensing opioids in emergency rooms. According to the CDC, rates of prescribing opioids in ERs decreased by a third from 2006 to 2017.  

Since patients now receive fewer opioids from the ER than in the past, they are likely to have fewer unused pills. However, paradoxically, that may create more incentive for them to hold onto the unused opioids in case they need them in the future.

It is not just emergency rooms that are providing patients with fewer opioids. Increasingly, patients discharged following surgeries receive less opioid medication or none at all, even though 80 percent of them feel their post-op pain was inadequately treated. 

Under-treated acute pain can cause permanent harm. In a recent issue of Anesthesiology, Editor-in-Chief Evan Kharasch, MD, and several of his colleagues penned an editorial, “Rational Perioperative Opioid Management in the Era of Opioid Crisis.”

They said there was little evidence to support the view that limiting opioids for post-operative pain was reducing abuse. Instead, it was leading to unintended consequences and “opioid phobia.” The authors specifically note that poorly controlled acute pain can lead to chronic pain.

People Worry Whether They Will Get Pain Medication

Many people clearly want to hold onto their unused medications. This is not new. However, the problem may worsen because, more than ever, patients fear that they will not be able to get opioid medication when they need it.

Keeping unused opioids is ill-advised for many reasons, the most important of which is that opioids should never be used except under the direction of a qualified provider. But there's another side to the story. If providers are going to refuse to treat pain, people will want to hold onto the medication they have been prescribed in order to avoid future suffering.

Of course, the intention of limiting the amount of opioids prescribed is to reduce the amount of drugs that could be diverted for non-medical use. But policies and practices designed to limit the amount of unused opioids may actually be dangerously creating a need to preserve, rather than dispose of, unused medication.

To paraphrase Dr. Kharasch, let us avoid making people in pain pay with unnecessary suffering for the opioid overprescribing sins of others.   

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.

Coronavirus Outbreak Raising Fear of Drug Shortages

By Pat Anson, PNN Editor

As the coronavirus spreads around the world, so are fears about drug supply shortages. While the prescription or over-the-counter medication you take may not come directly from China – the epicenter of the outbreak – chances are one of its ingredients does.

According to a recent study, nearly two-thirds of the world’s supply of acetaminophen comes from China. Known as paracetamol outside the United States, acetaminophen is a key ingredient in hundreds of over-the-counter pain relievers and cough, cold and flu medicines – from Excedrin and Tylenol to Theraflu and Alka-Seltzer Plus. It’s also used in opioid pain medications such as Vicodin.

While there’s no sign yet of an acetaminophen shortage, quarantines, travel restrictions and supply disruptions in China caused by the COVID-19 virus are causing some concern.

“One of the ugly secrets of the pharmaceutical industry is that the vast majority of raw materials that go into a prescription drug are produced overseas, mostly in China and India,” Geoffrey Joyce, PhD, chair of the Department of Pharmaceutical and Health Economics at the USC School of Pharmacy told the Los Angeles Times. “The coronavirus shutting down China or India for an extended period of time is likely to have a substantial impact on the supply of many drugs.”

Another academic expert made an even more alarming prediction.

“You’re going to see shortages,” William Comanor, PhD, a professor of health policy and economics at UCLA told The Times. “Tell your readers to stock up on generics!”

Vague Warning from FDA

There is already a shortage of at least one drug, although the head of the Food and Drug Administration didn’t identify what it was in an unusually vague statement released last night.

“A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug,” said FDA Commissioner Stephen Hahn, MD.

“It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.”

The FDA has contacted over 180 drug manufacturers around the world to remind them they have a legal obligation to notify the agency of any supply disruptions. About 20 pharmaceutical drugs that the FDA calls “non-critical” either come directly from China or have ingredients that come from there.

“We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date,” Hahn said.

The FDA is taking Chinese drug manufacturers at their word. Because of federal travel restrictions, FDA inspectors are not currently traveling to China to see for themselves.

Hahn’s statement also warned about manufacturing problems at dozens of Chinese facilities that make “essential” medical devices – but again without identifying what those devices are.

“We are aware that several of these facilities in China are adversely affected by COVID-19, citing workforce challenges, including the necessary quarantine of workers. While the FDA continues to assess whether manufacturing disruptions will affect overall market availability of these products, there are currently no reported shortages for these types of medical devices within the U.S. market,” said Hahn.

Face Mask Shortages

As for personal protective equipment --- such as face masks, gloves and surgical gowns – Hahn said the FDA has “heard reports of increased market demand and supply challenges” but was unaware of widespread shortages. China makes about half of the world’s supply of surgical masks but has stopped virtually all exports.

“Before the outbreak of the epidemic, we used to export 600,000-700,000 surgical masks a month, but now the amount is zero," David Peng, manager of a Chinese medical supplier, told the Chicago Tribune.

Walgreens, Home Depot, Lowe’s and other retailers in the U.S. are scrambling to meet demand for masks or have sold out.

The CDC has been urging healthy people not to use masks and other protective gear because they want those products available at healthcare facilities if the coronavirus outbreak becomes severe. Regular hand washing is the preferred alternative.

“CDC does not recommend that people who are well wear a facemask to protect themselves from respiratory illnesses, including COVID-19. You should only wear a mask if a healthcare professional recommends it,” the CDC says.

“A facemask should be used by people who have COVID-19 and are showing symptoms. This is to protect others from the risk of getting infected. The use of facemasks also is crucial for health workers and other people who are taking care of someone infected with COVID-19 in close settings (at home or in a health care facility).”

Who is most at risk of coronavirus? Unfortunately, its people who are already sick and have compromised immune systems, as Dr. Lynn Webster explained in a recent column.

“The people with increased risk for experiencing severe symptoms, and possibly dying of COVID-19, are seniors and those with chronic illness. Of course, many people in chronic pain are part of both risk groups. The mortality rate of COVID-19 has been reported to be about two percent,” Webster said. “People with chronic pain may be more susceptible to viruses in general, because chronic pain can change the way our immune systems work.”

For more information from CDC on the coronavirus outbreak, including symptoms, prevention and answers to frequentely asked questions, click here.