New Hampshire Law Protects Patient Access to Rx Opioids

By Pat Anson PNN Editor

Patient advocates around the country are looking with keen interest at a new law in New Hampshire that stipulates chronic pain patients should have access to opioid medication if it improves their physical function and quality of life.

HB 1639 was signed into law by Gov. Chris Sununu late last month. It amends state law to add some key provisions that protect the rights of both pain patients and their doctors.

Under the law, physicians and pharmacists are required to consider the “individualized needs” of pain patients, treat them with dignity, and ensure that they are “not unduly denied the medications needed to treat their conditions."   

Since the CDC’s controversial opioid prescribing guideline was released in 2016, dozens of states have adopted laws and policies that restrict the prescribing of opioids to the CDC’s recommended daily limit of 90 MME (Morphine Milligram Equivalent). Doctors who exceed that dose often come under the scrutiny of law enforcement and some pharmacists have stopped filling their prescriptions. As a result, millions of patients have been tapered to lower doses or cut off from opioids altogether, causing withdrawal, poorly treated pain and increased disability.  

Under the New Hampshire law, “all decisions” regarding treatment are to be made by the treating practitioner, who is required to treat chronic pain “without fear of reprimand or discipline.” Doctors in the state are also allowed to exceed the MME limit, provided the dose is “the lowest amount necessary to control pain” and there are no signs of a patient abusing their opioid medication.

“Ordering, prescribing, dispensing, administering, or paying for controlled substances, including opioid analgesics, shall not in any way be pre-determined by specific Morphine Milligram Equivalent (MME) guidelines.

For those patients who experience chronic illness or injury and resulting chronic pain who are on a managed and monitored regimen of opioid analgesic treatment and have increased functionality and quality of life as a result of said treatment, treatment shall be continued if there remains no indication of misuse or diversion.”

Importantly, the new law broadly defines chronic pain to include any pain that is intractable, high impact, episodic or relapsing — meaning the pain doesn’t have to be continuous.

“This innovative new law is historic in that it states that controlled substances, including opioids, can't be pre-determined by specific morphine milligram equivalents,” says Dr. Forest Tennant, a retired pain management specialist in California. “The law specifically states that patients can't be unduly denied the medications needed to treat their conditions. This point can't be over-emphasized.”

Another provision of the law requires that a diagnosis of chronic pain made by a physician anywhere in the U.S. that is supported by written documentation should be considered adequate proof that a patient has chronic pain. That part of the law is intended to make it easier for out-of-state pain patients to get treatment in New Hampshire.      

The law is the result of two years of lobbying by a small group of patient advocates known as the New Hampshire Pain Collaborative, which worked closely with state Sens. John Reagan and Tom Sherman in drafting the legislation. Key provisions eventually became part of the healthcare omnibus bill that won bipartisan support in the New Hampshire Senate and House of Representatives, and was signed into law by Governor Sununu.

Bill Murphy, a member of the Pain Collaborative, made this video to help other patients and advocates create similar legislation in their states:

“I would like to say a big congrats to all who worked on that project! Isn't it amazing what you can accomplish when you all work together?” said Donna Corley, director of the Arachnoiditis Society for Awareness and Prevention (ASAP), a patient advocacy group.

“Many patients aren't aware of just how important this bill truly is. This should have been enacted and should be implemented in every state in the United States to help secure safe, and reliable pain care treatment for all patients who suffer chronic pain in the United States. To be able to have diagnoses from other states and it be accepted by your doctor is phenomenal as well.”

“All concerned parties need to salute and follow suit of the New Hampshire law,” Dr. Tennant said in an email to PNN. “The tragedy of the recent over-reach to control opioid abuse, diversion, and overdoses has caused immense suffering for legitimate, chronic pain patients, an epidemic of suicides among deprived pain patients, and the forced retirement of many worthy physicians (including yours truly). All this ugliness would have been prevented with the New Hampshire law.”

According to the CDC, New Hampshire physicians wrote 46.1 opioid prescriptions for every 100 persons in 2018. That’s well below that national average of 51.4 prescriptions. That same year, 412 people died of drug overdoses in New Hampshire, the vast majority of them involving synthetic opioids such as illicit fentanyl and other street drugs.  Only 43 of those 412 deaths involved a prescription opioid.  

How Ketamine Infusions Helped Me

By Madora Pennington, PNN Columnist

Berkley Jones is a tough lady. Already a nurse, she joined the U.S. Air Force in her late 30’s, even though she had never run a mile in her life. She worked hard, made it through boot camp and went directly into officer training.

Her life changed after an allergic reaction so severe it required hospitalization. Berkeley never felt the same. Aching and tired, an immunologist diagnosed her with fibromyalgia. Berkley powered on.

Then, during a training exercise that simulated medical scenarios that might happen from a nuclear attack, she severely injured her arm. She awoke after surgery with her arm swollen to five times its normal size and feeling like it was on fire. The pain was unbearable. This was the beginning of her life with Complex Regional Pain Syndrome (CRPS).

For the next six years, her life was consumed by pain. Berkley tried everything doctors recommended. Nothing eased her agony. Wheelchair-bound, she left the military. “I basically stayed in bed most of the time. I was very depressed and in pain,” she recalls.

Berkley heard of ketamine from a friend, looked around and was accepted into a ketamine for CRPS study. She checked into the hospital for 5 days of intravenous ketamine infusions. The results were life-changing.

“By the end of the study I was able to use a cane instead of a wheelchair. I was able to get out of bed and my pain was down to livable levels,” she says.

Berkley went on to write a book, “Ketamine Infusions: A Patient's Guide” and organized Facebook groups to educate patients and doctors about ketamine.

From Anesthetic to Party Drug

Ketamine has become a trendy new treatment for pain and depression, but it’s actually been around for decades. Chemists first discovered ketamine in 1956. By the 1960s, it was in widespread use as an anesthetic, from veterinary offices to battlefields. Ketamine is only approved by the FDA for depression, anesthesia and post-surgical acute pain — which makes its use as a treatment for chronic pain off-label.

Ketamine is not an opioid and does not suppress breathing, making it relatively safe to use. But it does produce an unusual state of dissociation. Patients appear awake, but are often unable to respond to sensory input.

Because the experience is similar to psychosis (delirium, delusions or hallucinations), ketamine also became an underground party drug.

More and more uses are being found for this very unique compound. Ketamine triggers production of glutamate in the brain, which makes connections in the brain regrow. Cognition and mood improve as the brain gets a reboot from the damage of long-term stress that leads to excessive negative thoughts and feelings.

For chronic pain sufferers, ketamine temporarily reverses “central sensitization,” where the brain and spinal nerves receive so much pain input, they go off kilter and the slightest touch becomes painful. This can get so bad that some chronic pain sufferers come to find odors, light and sound extremely painful. Brain fog, poor memory, poor concentration and intense anxiety also happen as part of this cycle of pain overload.

Low Dose Ketamine

While hospitals treat chronic pain patients with multi-day, high dose infusions of ketamine, outpatient clinics have sprouted up around the country, offering less intense treatment with lower doses.

I began seeing anesthesiologist Dr. David Mahjoubi, of Ketamine Healing Clinic of Los Angeles this year. My foot was very swollen, weeks after surgery. I was looking for a way to reduce the inflammation without stopping the healing process, as ice, NSAIDs and steroids tend to do. I was fortunate to get an appointment, as some LA clinics have a two-year waiting list for infusions.

Dr. Mahjoubi explained ketamine to me this way: “It increases connections between brain cells, thus ‘rewiring’ brain circuitry. Ketamine also blocks pain receptors called NMDA. This is the mechanism for blocking pain. For persons with PTSD, the trauma seems to get processed in a mild, non-troubling way. Ketamine separates one from their anxiety or depression. A ‘release’ is how patients commonly describe it.”

In Dr. Mahjoubi’s experience, ketamine infusions multiple days in a row can be a bit tough. Spreading them out over several weeks can still get good results. It depends on the individual and the amount of relief they receive.

I was afraid to try ketamine, but agreed to a low dose, one-hour infusion. The swelling in my foot dramatically improved. Chronic, low-grade discomfort along my spine also disappeared. I felt emotional relief from past trauma, from pain and other life experiences.  

I continued with one low dose infusion every few weeks. I don’t like the experience of the infusion, but it has been well worth it.

I was relieved of minor aches and able to increase my exercise. I did not feel terror when pain kicked in. Sometimes the pain just floated away.

I no longer feared my physical therapist touching my neck, and noticed I was enjoying it. My mood improved and I felt smarter. My ability to concentrate and remember improved. 

My neighbor’s annoying dog sounded like he was a few houses away, not barking inside my head.

MADORA PENNINGTON GETTING AN INFUSION

I felt more connected with others and more accepting of life — less anxious, less terrorized, less inclined to ruminate after every infusion.

I do tend to have fatigue or short periods of intense emotion, which is not unusual. For me, this is just hard work on my health, like going to physical therapy.

Treatment for Depression

Tara Dillon, a nurse practitioner, opened Happier You, a ketamine clinic in Columbus, Ohio, after infusions helped her 20-year struggle with depression. She’s had good results treating patients with psychiatric complaints, such as depression, anxiety, and bipolar disorder.

“It's well-known that pain and psychiatric diagnoses, particularly depression, tend to coincide. Patients often report physical improvements such as relief from IBS, improved sleep, or increased energy after ketamine therapy,” she explained. “While everyone is nervous for the first infusion, since they don't know what to expect, most patients end up enjoying the experience.”

Tara usually starts with a low dose of 0.5mg ketamine over 40 minutes, but will titrate up depending on how a patient responds. The most common side effect is mild nausea. Ketamine is not a cure for chronic pain, and it takes time to have an effect.

“For me, ketamine never kicks in immediately. Some people get relief in the first week. It takes at least two weeks and for some, like me, it can take 3 to 4 weeks,” says Berkley Jones. “Once it does kick in, I usually have low pain levels for about 6 to 8 weeks and then they start to climb again. Sometimes overnight the pain comes back excruciating, but the majority of the time it’s a slow increase in my pain back to where it was.” 

Unfortunately, insurance won’t always cover ketamine. While the drug itself is cheap, the infusions are expensive because patients must be monitored. That is a real shame, as high-impact chronic pain affects 20 million adults in the United States. This is terrible burden not only to the sufferer, but to their loved ones and the community. Perhaps this will change if and when ketamine is FDA approved as a treatment for chronic pain.

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

Becoming Aware of Ingrained Thoughts Can Reduce Pain and Anxiety

By Dr. David Hanscom, PNN Columnist

Self-awareness is the essence of healing. You cannot stimulate your brain to develop in a given direction unless you become aware of who you are and where you are starting from. Awareness is a meditative tool that can be used to calm the nervous system, reduce chronic pain and anxiety, and move forward with your life.

There are four patterns of awareness that I’ve written about in previous columns that work for me:

Environmental awareness is placing your attention on a single sensation – taste, touch, sound, temperature, etc. What you are doing is switching sensory input from racing thoughts about pain to another sensation. This is the basis of mindfulness – fully experiencing what you are doing in the moment.

I use an abbreviated version that I call “active meditation,” which is placing my attention on a specific sensory input for 5 to 10 seconds. It is simple and can be done multiple times per day.  

Emotional awareness is more challenging. It often works for a while, but then it doesn’t. When you are suppressing feelings of anxiety, your body’s chemistry is still off and full of stress hormones. This translates into pain and other physical symptoms.

Allowing yourself to feel all of your emotions is the first step in healing because you can’t change what you can’t feel. Everyone that is alive has anxiety. It is how we survive.

Judgment awareness is a major contributor to the mental chaos in our lives. You create a “story” or a judgment about yourself, another person or situation that tends to critical and inflexible.

Dr. David Burns in his book “Feeling Good” outlines 10 cognitive distortions that are a core part of our upbringing. They include:

• Labeling yourself or others

• “Should” thinking – the essence of perfectionism

• Focusing on the negative

• Minimizing the positive

• Catastrophizing

These ingrained thoughts are the fourth and most problematic to be aware of. You cannot see or correct them without actively seeking them out.

Our Brains Are Programmed at an Early Age

Our family interactions in childhood are at the root of how we act as adults. They stem from our upbringing and the fact that our brains are “hard-wired” during our formative years. We know from recent neuroscience research that concepts and attitudes from childhood are embedded in our brains as concretely as our perception of a chair or table.  

I used to say that thoughts are real because they cause neurochemical responses in your body. But they are not reality. I was wrong.  

It turns out that your thoughts and ideals are your version of reality. Your current life outlook continues to evolve along the lines of your early programming or “filter.” It is why we become so attached to our politics, religion, belief systems, etc. It is also the reason that humans treat each other so badly based on labels.  

One example, amongst an endless list, was how we locked up “communists” during the McCarthy era of the 1950’s and 1960’s. It is also why so many minority groups are persecuted and often treat each other badly. 

It is critical to understand that these are attitudes and behaviors that you cannot see because they are inherent to who you are. It is also maybe the greatest obstacle to people getting along. We are hard-wired enough that we don’t recognize or feel these patterns -- it’s just what we do. It’s behavior that sits under many layers of defenses and has to be dug out by each person.  

Our family-influenced habits and actions are much more obvious to our spouses and immediate family than they are to us. We can only get in touch with them through counseling, seminars, psychotherapy, self-reflection, spousal feedback, etc. What you are not aware of can and will control you.  

Slowing Down 

Here is an example of awareness I learned at work. A few years ago, before I retired as a spine surgeon, I became aware that I consistently started to speed up towards the end of each surgery. I also realized that over the years, probably 80% of my dural tears (the envelope of spinal tissue containing the nerves and cerebrospinal fluid) occurred in the last 30 minutes of a long surgery.  

The fatigue factor was part of the problem, but speed was more critical. I still didn’t notice that I was speeding up. I needed feedback from my partners or assistants, so I asked them to act as my coaches. I’d stop for a few seconds and say, “The difficult part of this case is done. It would be easy for me to relax and hurry to finish. Please speak up if you see me starting to rush.”  

Every move in spine surgery is critical, so I had to make the choice to consciously slow down. The end of each surgery is just as important as the beginning and middle. My complication rate dropped dramatically when I became more aware of what I was doing. 

This is a brief overview of how awareness plays a role in successfully navigating daily life. It’s something of a paradox, because when we are truly immersed in the moment there are no levels of awareness. It’s just complete “engagement-in-the-present-moment” awareness.

There are many layers to this discussion, but I hope this is a good starting point for you to understand the importance of mindful awareness.  

Dr. David Hanscom is a retired spinal surgeon. He recently launched a new website – The DOC Journey – to share his own experience with chronic pain and to offer a pathway out of mental and physical pain through mindful awareness and meditation.

Guideline Recommends Topical Pain Relievers for Muscle Aches and Joint Sprains

By Pat Anson, PNN Editor

A new guideline for primary care physicians recommends against the use of opioid medication in treating short-term, acute pain caused by muscle aches, joint sprains and other musculoskeletal injuries that don’t involve the lower back.

The joint guideline by the American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP) – which collectively represent nearly 300,000 doctors in the U.S. – recommends using topical pain creams and gels containing non-steroidal anti-inflammatory drugs (NSAIDs) as first line therapy. Other recommended treatments include oral NSAIDs, acetaminophen, specific acupressure, or transcutaneous nerve stimulation (TENS).

Musculoskeletal injuries, such as ankle, neck and knee injuries, are usually treated in outpatient settings. In 2010, they accounted for over 65 million healthcare visits in the U.S., with the annual cost of treating them estimated at over $176 billion.

"As a physician, these types of injuries and associated pain are common, and we need to address them with the best treatments available for the patient. The evidence shows that there are quality treatments available for pain caused by acute musculoskeletal injuries that do not include the use of opioids," said Jacqueline Fincher, MD, president of ACP.

Opioids, including tramadol, are only recommended in cases of severe injury or intolerance to first-line therapies. While effective in treating pain, the guideline warns that a “substantial proportion” of patients given opioids for acute pain wind up taking them long-term.   

The new guideline, published in the Annals of Internal Medicine, recommends topical NSAIDs, with or without menthol, as the first-line therapy for acute pain from non-low back, musculoskeletal injuries. Topical NSAIDs were rated the most effective for pain reduction, physical function, treatment satisfaction and symptom relief.

Treatments found to be ineffective for acute musculoskeletal pain include ultrasound therapy, non-specific acupressure, exercise and laser therapy.

"This guideline is not intended to provide a one-size-fits-all approach to managing non-low back pain," said Gary LeRoy, MD, president of AAFP. "Our main objective was to provide a sound and transparent framework to guide family physicians in shared decision making with patients."

Guideline Based on Canadian Research

Interestingly, the guideline for American doctors is based on reviews of over 200 clinical studies by Canadian researchers at McMaster University in Ontario, who developed Canada’s opioid prescribing guideline. The Canadian guideline, which recommends against the use of opioids as a first-line treatment, is modeled after the CDC’s controversial 2016 opioid guideline.  

After reviewing data from over 13 million U.S. insurance claims, McMaster researchers estimated the risk of prolonged opioid use after a prescription for acute pain was 27% for “high risk” patients and 6% for the general population.

"Opioids are frequently prescribed for acute musculoskeletal injuries and may result in long-term use and consequent harms," said John Riva, a doctor of chiropractic and assistant clinical professor in the Department of Family Medicine at McMaster. "Potentially important targets to reduce rates of persistent opioid use are avoiding prescribing opioids for these types of injuries to patients with past or current substance use disorder and, when prescribed, restricting duration to seven days or less and to lower doses."

Riva and his colleagues said patients are also at higher risk of long-term use if they have a history of sleep disorders, suicide attempts or self-injury, lower socioeconomic status, higher household income, rural residency, lower education level, disability, being injured in a motor vehicle accident, and being a Medicaid recipient.

A history of alcohol abuse, psychosis, episodic mood disorders, obesity, and not working full-time “were consistently not associated with prolonged opioid use.”

The McMaster research, also published in the Annals of Internal Medicine, was funded by the National Safety Council (NSC), a non-profit advocacy group in the U.S. supported by major corporations and insurers. The NSC has long argued against the use of opioid pain relievers, saying they “do not kill pain, they kill people.”

What Is the Best Kind of Face Covering?

By Dr. Lynn Webster, PNN Columnist

As we learn more about COVID-19, top health officials have updated their advice about how we can protect ourselves from the virus.

On February 29, U.S. Surgeon General Jerome Adams, MD, tweeted: "Seriously people- STOP BUYING MASKS! They are NOT effective in preventing general public from catching #Coronavirus."

By July 20, Adams had changed his mind and was urging the public to “wear a face covering," although he still believes that wearing a mask should not be nationally mandated.

The Centers for Disease Control and Prevention also recommends wearing face masks when we are out in public and social distancing is difficult to maintain, or when we are around people who do not live in our household. So does the Food and Drug Administration.

There are different types of face masks, though, and some work better than others.

N95 masks provide the best possible protection, followed by surgical masks, but they should be reserved for healthcare workers. Personal protective equipment (PPE) is still in short supply globally because of hoarding, misuse and increased demand -- which puts healthcare workers and their patients at risk.

Members of the public can buy or make their own cloth masks to wear. Laboratory tests have shown that, when worn properly, cloth masks reduce the spray of viral droplets.

Some individuals, however, find it uncomfortable to wear a mask, or they may have a medical condition or disability that makes it difficult for them to breathe. Face masks may also fog up eyeglasses, irritate skin and inhibit communication by muffling the voice. People also frequently touch their faces to adjust or remove their masks, and that may increase the risk of infection.

Not all face masks provide equal protection. At best, cloth masks can be as effective as surgical masks. But using some variants, such as “neck gaiters” made of a polyester spandex, may even be worse than not wearing a mask at all.

Neck gaiters are less restrictive than masks, so they may be more comfortable. But their porous fabric breaks large viral particles into smaller ones, and that may allow them to linger in the air for a longer period of time. That makes them risky to the wearer and people around them.

Face Shields May Be Better Alternative

Jennifer Veltman, MD, chief of infectious diseases at Loma Linda University Health, recommends face shields made of clear plastic or plexiglass to people who are unable or unwilling to wear a mask. According to Veltman, if someone coughs 18 inches from you while you are wearing a face shield, the viral exposure is reduced by 96 percent.

Dr. Amesh Adalja, a senior scholar with the Johns Hopkins Center for Health Security, believes that face shields may eventually replace cloth masks because they are more comfortable to wear and easier to breathe with. And because they extend down from the forehead, face shields protect the eyes as well as the nose and mouth. That can be important since viruses can enter the body via the eyes. It is also easy to wipe face shields clean and reuse them.

Dr. Frank Esper, a pediatric infectious disease specialist at the Cleveland Clinic, agrees that face shields have many benefits over cloth masks. However, they also have drawbacks. For example, he points out that viruses survive longer on plastic face shields than on cloth masks. Also, if a person wearing a face shield coughs, viral droplets can escape because of the gap between the shield and the mouth.

Dr. Anthony Fauci, the nation’s top infectious disease expert, says, "If you have goggles or an eye shield, you should use it. It's not universally recommended, but if you really want to be complete, you should probably use it if you can.”

White House coronavirus response coordinator Dr. Deborah Birx may have the best recommendation of all: wear a cloth mask and a face shield simultaneously. The mask, she says, protects others, while the face shields protect wearers.

Advice about how to protect ourselves will evolve as we learn more about the virus. We’ll be needing face coverings for an indefinite time period, so it is wise to become familiar with the different options for protecting yourself and your family.

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

The Dismal Trajectory of Covid-19

By Roger Chriss, PNN Columnist

The coronavirus pandemic continues to sweep across the United States. So too does misleading information about the pandemic and its likely trajectory.

“We have fewer deaths per capita than the United Kingdom and most other nations in Western Europe, and heading for even stronger numbers,” President Trump said in a press briefing this week.

Although the U.S. has a lower per capita death rate from Covid-19 than some European nations, the president’s claim is both mistaken and simplistic. Worldwide, the U.S. ranks fourth in deaths per 100,000 people, according to the Johns Hopkins Coronavirus Resource Center.

More important is the trajectory of the pandemic. European nations were hit hard by the coronavirus early on. For example, Belgium, Italy and Spain saw most of their deaths in March and April, and almost none since.

It is more informative to look at how countries have done after the initial onslaught. In other words, what are the trends since May 1st?

The trends in the U.S. are dismal, with only Brazil and India beginning to compare. According to STAT News’ Covid-19 Tracker, the U.S. has had over 100,000 deaths since May 1. Spain, by comparison, has had 3,600 deaths; Belgium: 1,300; Sweden: 3,000; Italy: 7,000; and the United Kingdom: 19,000 deaths.

In other words, the U.S. has had about three times as many deaths as all the other countries listed above combined, whose population is 192 million or about two-thirds that of the U.S. Only the United Kingdom has a comparable rate of increase in deaths.

Trends for confirmed cases since May 1 are even worse. Back then the U.S. had just over 1 million coronavirus cases. It has since more than quintupled, now totaling over 5.2 million cases. In that same time period, infections in the UK doubled and most other European countries barely added any.

Disease trajectories look even worse for the U.S., which keeps adding more than 50,000 new cases daily, despite testing rates falling by over 10% since mid-July. On August 11, the U.S. saw about 1,500 deaths, more than the total number of deaths in Belgium since May 1.

A More Realistic Case-Fatality Rate

Covid-19 deaths lag new infections by about four weeks. This means the total deaths today can be divided by the total number of cases from four weeks ago to determine what the death rate is.

Covid Tracking data shows the U.S. had 145,245 deaths as of July 31. Four weeks prior to that, on July 3, there were 2,786,467 cases. This gives a case-fatality rate of 5.21% for those dates, higher because of the temporal adjustment that accounts for how Covid-19 behaves.

Moreover, because of more testing, the U.S. has greatly increased its total number of confirmed cases, which in turn lowers the case-fatality ratio. In other words, improvements in the case-fatality ratio are due to testing rates rising even faster than death rates, and not because of an effective pandemic response.

Further, there is considerable under-reporting of deaths in the U.S. For instance, some states have updated their numbers with backfill deaths, as New Jersey did with 1,800 deaths in June, Texas did with 631 in July, and Florida did with dozens last week.

It is also informative to look at the total number of deaths. A new analysis by The New York Times estimates that there could be as many as 200,000 excess deaths attributable to Covid-19 by late July.

Lasting Symptoms

We’re also learning that people who recover from Covid-19 often have symptoms that linger long after the active virus goes away. The CDC reports that about a third of patients with Covid take more than three weeks to recover.

Dr. Anthony Fauci, told STAT News that many survivors suffer from profound exhaustion, muscle pain, headaches, and have trouble thinking and remembering – symptoms that are “highly suggestive” of myalgic encephalomyelitis, the chronic illness commonly called chronic fatigue syndrome or ME/CFS.  

The coronavirus pandemic is now recognized as being as deadly as the 1918 flu pandemic. The worst may yet lay ahead. CDC director Dr. Robert Redfield recently warned that when autumn arrives and the flu season returns, the U.S. could be facing the “worst fall” in its history if more Americans do not adopt prevention measures like wearing masks and social distancing.

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. 

Does Transparency in Pricing Really Lower Healthcare Costs?

By Barby Ingle, PNN Columnist

Each year I get asked to support multiple legislative bills that could impact the chronic pain community. I look through them, think them through, and have written, called, testified and shared many over the years.

But sometimes a bill I supported comes back to haunt me as a patient. The intended consequences are not what I thought they would be.

Such is the case in Arizona, where I live. A state law was passed in 2013 calling for transparency in healthcare pricing (HB 2045). The law requires most healthcare providers to tell patients the “direct pay price” for a service or procedure. I always thought it was a good thing to have transparency in pricing and for patients to know what their responsibility is, so I supported the bill.

In 2019, Arizona passed another law (HB 2166) that authorized providers to collect “advance payments” from patients before a service is performed and without waiting for insurers to pay. The new law was quick to be adopted and providers have already started using it more than expected. This is causing an issue in getting the healthcare we need in a proper and timely manner.

The law really didn't affect me until this year, when I went through all the testing and multiple office visits with a new provider. Then I was called to the office of the “scheduling manager.” This was right after the doctor told me that I need a procedure on my bladder. I have an issue known as neurogenic bladder, where I lose control of my bladder nerves and muscles.

In the office, the woman wrote on a piece of paper the cost of the procedure ($30,000) based on my insurance (Medicare) and how much I would have to pay in advance, which was $6,000.

Before the law went into effect, I could pay the bill over time and get the procedure done when I needed it. But now, she says, I had to pay the entire $6,000 before even scheduling the procedure. I do not have $6,000 to pay upfront, so I am unable to schedule it.

New Hospital Rules

Arizona is not the only state that has passed healthcare price transparency laws; California, Connecticut, Louisiana, Maine, Maryland, Nevada, Oregon, Tennessee and Vermont have similar laws.

Federal rules are slated to go into effect in January, 2021 that will require hospitals to disclose their price information, including their negotiated prices with insurers. It is part of an effort by the Trump administration to increase price transparency in hopes of lowering healthcare costs on everything from hospital services to prescription medicines.

The federal efforts are controversial and have already faced court challenges. For good reason, seeing how transparency is being implemented in Arizona.  

Both HB 2045 and HB 2166 are good examples of bills I advocated for that are now being used against me and others in the chronic pain community who are low income or under-insured. It’s just a new way to stop healthcare or slow it down. Instead of having insurance companies delay care with prior authorizations and step therapy -- which I have been through as well -- they stop you at the doctor's office now.  

The same thing happened when I came down with Valley Fever pneumonia this past November. My provider ordered chest x-rays, but before I could get them, I had to pay my portion of the bill. I had to borrow money to get the x-rays done.  

Turns out I was way sicker than my provider thought and he apologized afterwards. Once I was diagnosed, follow up x-rays were covered, except when one lady was at the desk. She always charges me and says she has to because of the price transparency rules.  

I am hearing more and more stories about HB 2166 being used against the chronic and rare disease communities. As I said, it is odd to not want full transparency, but I would rather have access to healthcare when it is needed and then work on paying the bill afterward. Otherwise, like me, many of you may not receive the care you need, making our health worse and more expensive. 

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

Study Finds Low Risk of Rx Opioid Abuse Among Young People

By Pat Anson, PNN Editor

The stories are heartbreaking. A young man gets a prescription for opioid pain medication and quickly becomes addicted.

“I lost everything. I had to leave school, and stop playing sports in college. I started to watch my life slip away. These drugs are addictive. One prescription can be all it takes to lose everything,” says Mike.

A mother loses her son to an overdose.

“My son… was 20 years old when he was prescribed opioids,” says Ann Marie. “It took him five days to get addicted.”

These are some of the real-life stories being told in a CDC awareness campaign that warns against the use of prescription opioids. “It only takes a little to lose a lot,” is the theme in a series of CDC videos, billboards and online ads.

The stories are sad, but the widespread belief that adolescents and young adults can quickly become addicted to prescription opioids is not accurate for the vast majority of young people, according to a large new study published in JAMA Pediatrics.

Researchers at Indiana University looked at a database of over 77,000 young people in Sweden between the ages of 13 and 29 who were prescribed opioids for the first time. They were compared to a control group that was given non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief. Both groups had no previous signs of substance abuse.

Only 4.6% of those prescribed an opioid developed a substance use disorder or other substance-related issue, such as an overdose or criminal conviction within five years of being prescribed.  That compared to 2.4% of those in the control group.

"By using several rigorous research designs, we found that there was not a huge difference -- in fact, the difference was smaller than some previous research has found,” said Patrick Quinn, PhD, an assistant professor at the IU School of Public Health-Bloomington. “But the study still shows that even a first opioid prescription may lead to some risk."

Interestingly, young people given oxycodone were at no greater risk of developing a substance abuse problem than those given “weaker” opioids such as codeine or tramadol.

Quinn says further research is needed to determine how much substance abuse risk is caused by opioid medication alone and how much is related to other issues, such as mental health, genetics and environmental factors.

"We need to have a good understanding of what those risks might be in order for patients and doctors to make informed decisions," said Quinn. "Our findings highlight the importance of screening for substance use disorders and other mental health conditions among patients with pain, including those receiving opioid therapy."

A 2018 study of young people given opioids after their wisdom teeth were removed also found the risk of long-term use low. The study of over 70,000 teens and young adults found that only 1.3% were still being prescribed opioids months after their initial prescription by a dentist.  

Pharmacies Sued for Discrimination Against Pain Patients

By Pat Anson, PNN Editor

National class action lawsuits have been filed against three of the nation’s largest pharmacy chains for discriminating against pain patients trying to fill legitimate prescriptions for opioid medication. 

Class action complaints against Walgreens, Costco and CVS Pharmacy were filed in California and Rhode Island on behalf of two women seeking legal relief that will allow them to get their opioid prescriptions filled without delays or restrictions, and without the fear that their prescriptions will be denied. 

Edith Fuog, a 48-year old Florida woman and breast cancer survivor, lives with trigeminal neuralgia, lupus, arthritis and other chronic pain conditions. Fuog’s lawsuit alleges that since 2017, CVS pharmacies have refused to fill her prescriptions for opioid medication in violation of the American with Disabilities Act (ADA), the Rehabilitation Act of 1973 and the anti-discrimination provisions of the Affordable Care Act.  Her complaint was filed in Rhode Island, where CVS has its corporate headquarters.

43-year old Susan Smith of Castro Valley, California, filed a similar class action against Walgreens and Costco in the Northern District of California. Smith suffers from Mesial Temporal Lobe Sclerosis, which resulted in scar tissue in her brain that causes severe chronic migraines. The only medication that gives Smith relief from headache pain are opioids.  She alleges that Walgreens and Costco pharmacies refused to fill her opioid prescriptions in violation of federal law.

"Many Americans are unaware of the difficulties chronic pain patients have getting pharmacies to fill their lawfully-obtained opioid prescriptions. It is not only a crisis for Edith and Susan, but for millions of Americans due to the backlash caused in part by the national publicity concerning opioid abuse,” said Scott Hirsch, a Florida lawyer who is one of several lead attorneys handling the cases.

“These lawsuits seek to allow the millions of chronic pain patients to obtain their legitimate opioid prescriptions without being discriminated against, harassed, denied, or embarrassed.  It will hopefully improve their quality of life and save many lives in the process."

Pain patients in the U.S. have complained for years about pharmacists refusing to fill their opioid prescriptions or reducing them to lower doses. It’s also not uncommon for patients to encounter delays and excuses, such as a pharmacy claiming it was out of stock of a particular medication. The California and Rhode Island cases are believed to be the first class action lawsuits to address the problem.

“I have always thought that this is one of the better potential legal avenues for an ADA action regarding prescription opioids.  It is a violation for any person with a disability to be denied service by a place of public accommodation, and pharmacies are clearly covered as places of public accommodation under the ADA,” said Kate Nicholson, a patient advocate and civil rights lawyer who handled discrimination cases at the Department of Justice for over 20 years.

“Whether this will succeed will depend on a lot of intangibles such as the quality of the complaints, what is learned during discovery about any nationwide policies the pharmacy chains had in place, or, alternatively, repeated instances of fills for legitimate prescriptions being denied. Also, whether the court which hears it considers the refusal to fill prescriptions tantamount to a denial of service. I think it’s promising.”

Corporate Policies Profile Patients

While pharmacies have a legal right to refuse to fill prescriptions they consider suspicious or inappropriate, the lawsuits allege that CVS, Walgreens and Costco adopted corporate policies that encourage their pharmacists to profile patients as drug abusers and impose limits on opioid medication. The companies did not respond to a request for comment.

Walgreens adopted a “secret checklist” in 2013 that required its pharmacies to watch for red flags such as patients paying for opioid prescriptions in cash, seeking an early refill or taking an “excessive” number of pills. If anything was suspicious, pharmacists were instructed to “inform the patient that it may take additional time to process the prescription.”  The policy was implemented after Walgreens was fined $80 million by the DEA for violating rules for dispensing controlled substances.

CVS adopted a policy in 2017 to limit the dose and supply of opioids for short-term, acute pain to seven days. For both acute and chronic pain, opioid prescriptions were not filled if they exceeded a 90mg MME daily dose. Customers enrolled in CVS’ pharmacy benefit plan were also required to try immediate release formulations, before using extended release opioids. The policy was adopted after CVS was fined hundreds of millions of dollars for violations of the Controlled Substances Act.

In a recent letter to the CDC, the American Medical Association called the CVS and Walgreens policies "inappropriate" because they misapplied the CDC opioid guideline in ways that were harmful to patients. The AMA said it has received numerous complaints about Walgreens pharmacists refusing to fill prescriptions because of corporate policy.

Other big pharmacy chains have similar policies. Walmart has been accused of “blacklisting” doctors for writing high dose prescriptions. And a tearful video posted online by a California woman with stage 4 breast cancer went viral after a Rite Aid pharmacist refused to fill her prescription for Norco.

The law firms that filed the cases against Walgreens, Costco and CVS are seeking additional information from patients interested in joining the legal action at this website.

Hospitals Hit Hard by Loss of Joint Replacement Surgeries

By Bernard J. Wolfson, Kaiser Health News

Dr. Ira Weintraub, a recently retired orthopedic surgeon who now works at a medical billing consultancy, saw a hip replacement bill for over $400,000 earlier this year.

“The patient stayed in the hospital 17 days, which is only 17 times normal. The bill got paid,” mused Weintraub, chief medical officer of Portland, Oregon-based WellRithms, which helps self-funded employers and workers’ compensation insurers make sense of large, complex medical bills and ensure they pay the fair amount.

Charges like that go a long way toward explaining why hospitals are eager to restore joint replacements to pre-COVID levels as quickly as possible — an eagerness tempered only by safety concerns amid a resurgence of the coronavirus in some regions of the country. Revenue losses at hospitals and outpatient surgery centers may have exceeded $5 billion from canceled knee and hip replacements alone during a roughly two-month hiatus on elective procedures earlier this year.

The cost of joint replacement surgery varies widely — though, on average, it is in the tens, not hundreds, of thousands of dollars. Still, given the high and rapidly growing volume, it’s easy to see why joint replacement operations have become a vital chunk of revenue at most U.S. hospitals.

The rate of knee and hip replacements more than doubled from 2000 to 2015, according to inpatient discharge data from the Agency for Healthcare Research and Quality. And that growth is likely to continue: Knee replacements are expected to triple between now and 2040, with hip replacements not far behind, according to projections published last year in the Journal of Rheumatology.

Joint procedures are usually not emergencies, and they were among the first to be scrubbed or delayed when hospitals froze elective surgeries in March — and again in July in some areas plagued by renewed COVID outbreaks. Loss of the revenue has hit hospitals hard, and regaining it will be crucial to their financial convalescence.

“Without orthopedic volumes returning to something near their pre-pandemic levels, it will make it difficult for health systems to get back to anywhere near break-even from a bottom-line perspective,” said Stephen Thome, a principal in health care consulting at Grant Thornton, an advisory, audit and tax firm.

Billions in Revenue Lost

It’s impossible to know exactly how much knee and hip replacements are worth to hospitals, because no definitive data on total volume or price exists.

But using published estimates of volume, extrapolating average commercial payments from published Medicare rates based on a study, and making an educated guess of patient coinsurance, Thome helped KHN arrive at an annual market value for American hospitals and surgery centers of between $15.5 billion and $21.5 billion for knee replacements alone.

That suggests a revenue loss of $1.3 billion to $1.8 billion per month for the period the surgeries were shut down. These figures include ambulatory surgery centers not owned by hospitals, which also suspended most operations in late March, all of April and into May.

If you add hip replacements, which account for about half the volume of knees and are paid at similar rates, the total annual value rises to a range of $23 billion to $32 billion, with monthly revenue losses from $1.9 billion to $2.7 billion.

The American Hospital Association projects total revenue lost at U.S. hospitals will reach $323 billion by year’s end, not counting additional losses from surgeries canceled during the current coronavirus spike. That amount is partially offset by $69 billion in federal relief dollars hospitals have received so far, according to the association. The California Hospital Association puts the net revenue loss for hospitals in that state at about $10.5 billion, said spokesperson Jan Emerson-Shea.

Hospitals resumed joint replacement surgeries in early to mid-May, with the timing and ramp-up speed varying by region and hospital. Some hospitals restored volume quickly; others took a more cautious route and continue to lose revenue. Still others have had to shut down again.

At the NYU Langone Orthopedic Hospital in New York City, “people are starting to come in and you see the operating rooms full again,” said Dr. Claudette Lajam, chief orthopedic safety officer.

At St. Jude Medical Center in Fullerton, California, where the coronavirus is raging, inpatient joint replacements resumed in the second or third week of May — cautiously at first, but volume is “very close to pre-pandemic levels at this point,” said Dr. Kevin Khajavi, chairman of the hospital’s orthopedic surgery department. However, “we are constantly monitoring the situation to determine if we have to scale back once again,” he said.

In large swaths of Texas, elective surgeries were once again suspended in July because of the COVID-19 resurgence. The same is true at many hospitals in Florida, Alabama, South Carolina and Nevada.

The Mayo Clinic in Phoenix suspended nonemergency joint replacement surgeries in early July. It resumed outpatient replacement procedures the week of July 27, but still has not resumed nonemergency inpatient procedures, said Dr. Mark Spangehl, an orthopedic surgeon there. In terms of medical urgency, joint replacements are “at the bottom of the totem pole,” Spangehl said.

In terms of cash flow, however, joint replacements are decidedly not at the bottom of the totem pole. They have become a cash cow as the number of patients undergoing them has skyrocketed in recent decades.

‘Industrial-Scale’ Surgeries

The volume is being driven by an aging population, an epidemic of obesity and a significant rise in the number of younger people replacing joints worn out by years of sports and exercise.

It’s also being driven by the cash. Once only done in hospitals, the operations are now increasingly performed at ambulatory surgery centers — especially on younger, healthier patients who don’t require hospitalization.

The surgery centers are often physician-owned, but private equity groups such as Bain Capital and KKR & Co. have taken an interest in them, drawn by their high growth potential, robust financial returns and ability to offer competitive prices.

“Generally the savings should be very good — but I do see a lot of outlier surgery centers where they are charging exorbitant amounts of money — $100,000 wouldn’t be too much,” said WellRithm’s Weintraub, who co-owned such a surgery center in Portland.

After canceling his hip replacement surgery in March because of COVID-19, Matthew Davis overcame his concerns and rescheduled in June because the procedure was performed at an outpatient surgery center, which meant no overnight hospital stay. (Matthew Davis)

Fear of catching the coronavirus in a hospital is reinforcing the outpatient trend. Matthew Davis, a 58-year-old resident of Washington, D.C., was scheduled for a hip replacement on March 30 but got cold feet because of COVID-19, and canceled just before all elective surgeries were halted. When it came time to reschedule in June, he overcame his reservations in large part because the surgeon planned to perform the procedure at a free-standing surgery center.

“That was key to me — avoiding an overnight hospital stay to minimize my exposure,” Davis said. “These joint replacements are almost industrial-scale. They are cranking out joint replacements 9 to 5. I went in at 6:30 a.m. and I was walking out the door at 11:30.”

Joint Replacement Often Unnecessary

Acutely aware of the financial benefits, hospitals and surgery clinics have been marketing joint replacements for years, competing for coveted rankings and running ads that show healthy aging people, all smiles, engaged in vigorous activity.

However, a 2014 study concluded that one-third of knee replacements were not warranted, mainly because the symptoms of the patients were not severe enough to justify the procedures.

“The whole marketing of health care is so manipulative to the consuming public,” said Lisa McGiffert, a longtime consumer advocate and co-founder of the Patient Safety Action Network. “People might be encouraged to get a knee replacement, when in reality something less invasive could have improved their condition.”

McGiffert recounted a conversation with an orthopedic surgeon in Washington state who told her about a patient who requested a knee replacement, even though he had not tried any lower-impact treatments to fix the problem.

“I asked the surgeon, ‘You didn’t do it, did you?’ And he said, ‘Of course I did. He would just have gone to somebody else.’”

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

Finding Pain Relief in a Virtual World

By Madora Pennington, PNN Columnist

I am sitting on a deserted beach in Tasmania, listening to the gently lapping waves. All my worries fade in just 3 minutes.

While on my couch, I am touring the famous sites of London. Have I been on vacation? I feel as if I have.

I am by a creek in Bavaria. Water gently crashes against the rocks. Leaves fall to the ground. In four minutes, I am in state of joy.

Underwater with a school of dolphins, twisting my head to get the best views as they swim above me and all around, I forget anything that bothers me, physical or mental.

How can I be in so many places? I am using a virtual reality program designed to relieve chronic pain. I love it. I look forward to doing it every day.

Later, when I am out and about, a sound I heard during my VR sessions, perhaps the swaying of a tree, makes my body relax without effort.

The AppliedVR headset I am using looks like a blacked-out snorkeling mask. It came with a warning not to expose it to direct sunlight, and to take great care not to scratch the lenses. The company loaned me the device to try at no cost and with no stipulations for this review.

Virtual reality (VR) had its start as entertainment in video gaming. Headsets have speakers or earphones, and are usually connected to a joystick or hand controller. When the user moves their head, tracking software shifts the images, providing an immersive experience into a full 360-degree view of a 3D world.

Besides gaming, VR has a growing number of practical uses. VR technology is used to teach dangerous jobs like piloting or to give doctors simulated practice at surgery. The U.S. military uses VR to train soldiers to fight and build mental resilience for battle. Ford employees use VR to inspect and look for problems in virtual automobiles before they are even manufactured. Architects and engineers use it to evaluate and find problems in their design work.

In a medical setting, VR therapy was first used in caring for patients who suffered burn wounds, which can be so painful that even opioids can be insufficient. A study found that VR, when coupled with pain medication, provided burn patients with significant relief.

More Than Just Distraction

How does VR make such a difference in pain?

“The most acceptable theory is the Gate theory of attention. It postulates that VR reduces the perception of pain by absorbing and diverting attention away from pain,” says Dr. Medhat Mikhael, a pain management specialist.

But there’s more to it. Dr. Brennan Spiegel, director of Cedars-Sinai's Health Service Research, completed a VR study on 120 hospitalized patients in 2019, which showed that VR significantly reduces pain. It was most effective for severe pain.

“Virtual reality is a mind-body treatment that is based in real science. It does more than just distract the mind from pain, but also helps to block pain signals from reaching the brain, offering a drug-free supplement to traditional pain management," Spiegel said.

Short-term, acute pain is a different beast than chronic pain. Only a few studies have been done using VR to treat chronic pain, which can overwhelm the nervous system, making the body even more sensitive to and aware of pain. This cycle can become so entrenched it can cause the body to interpret benign stimuli, such as the light brush of fabric against skin, as painful.

Early studies on VR for chronic pain are promising. In a study published in 2016, chronic pain patients had an average 60% reduction in pain from VR treatment. A third of the participants experienced total pain relief while doing VR sessions. They had a wide variety of conditions, such as spine pain, hip pain, myalgia, connective tissue disease, interstitial cystitis, chest pain, shoulder pain, abdominal pain and neuropathy. 

Another study recently found that VR reduces pain and improves mood and sleep in people living with fibromyalgia or chronic lower back pain.  

Pain Drifts Away

I’ve had a lifetime of chronic pain from the collagen disease, Ehlers-Danlos Syndrome. My body is very weak and flimsy. Having chronic pain and disability sometimes makes me feel resentful and betrayed by my own body.

In one VR session, I stare into the heavens. I am shown a projection of a human body and nervous system. A kind, encouraging woman explains simply and compassionately the phenomenon of pain. I hate my body less in two minutes.

Ordinarily, I would never play a video game. I don’t like cartoons. Meditating makes me anxious. I find it difficult to even lose myself watching a movie. I would not have thought I would respond well to virtual reality. But from the first brief session, I did.

I learned how to calm and balance my nervous system in an animated forest. Gently encouraged to breathe in time with a giant whimsical tree, the ground and surrounding plants change, becoming ever more colorful each time I exhale. The loving woman tells me I have changed myself and the outside world. I have to agree.

Some sessions are games that teach me to redirect my attention away from pain. In a cartoon winter wonderland, I shoot snowballs at happy teddy bears, who giggle when I hit them. I have made the teddy bears and myself happy.

In others programs, I swim with jellyfish. Or sunbathe on a beach in Australia. Or sit by a stream in the snowfall. You can watch a sample of these programs below.

The benefits of VR therapy continued for me after the sessions ended. When pain or panic about pain began to set in, I found it drifts away rather than latching onto me like it used to.

After a couple weeks of VR, during a visit to physical therapist, I noticed I was no longer afraid of her touching my neck and back, and actually enjoyed it.

VR reminds me of times in my life when I was fully engaged in the moment and overwhelmed by wonder or beauty. As a child swimming in the ocean, once I was surrounded by dolphins. They clicked and called to each other. I immediately forgot how cold I was and how my wet-suit was cutting off the circulation in my hands.

VR took me back to other transcendent moments of my life, like playing in an orchestra, surrounded by instruments producing layers of organized sound. Standing in front of Van Gogh’s Bedroom. A ride at Disneyland. Falling in love.

My only criticism of VR is the weight of the headset. The device is heavy and could be difficult for someone with neck or head pain to tolerate.

AppliedVR’s technology is being used in hundreds of hospitals, but it is not yet available for home use. The company hopes for a broader launch in 2021, but getting insurance coverage will be key.

"We know that living with and managing chronic pain can be a debilitating and costly challenge that is only exacerbated by the COVID crisis.  As such, we are focused on achieving our vision of delivering safe and effective VR therapeutics into the home where the need for non-opioid chronic pain treatment options is greatest,” says AppliedVR CEO Matthew Stoudt.

“We are now focused on partnering with payers to demonstrate how our chronic pain VR therapeutic improves health outcomes, reduces costs and empowers patients to lead their best lives.  This is the key to making VR a reimbursable standard of care for pain management."

In addition to pain, VR therapy is also being used to relax people going through dental procedures, chemotherapy, physical rehabilitation, phobias, anxiety and post-traumatic stress disorder (PTSD).

You cannot talk your brain out of perceiving pain, but with VR it finds other, better things to do than just focus on pain. Cognitive behavioral therapy and self-soothing techniques do that too, but VR disengaged my brain from the pain perception cycle at a much deeper level, just as pain once hijacked my thoughts and attention.

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

How to Say Goodbye When Someone is Dying

By Dr. Lynn Webster, PNN Columnist

Once, a patient with chronic pain due to an immunodeficiency made an appointment with me to say goodbye. For years, he had received intravenous therapies for his infections, but they had all stopped working. His other doctors had already told him that nothing more could be done, and he had little time left to live. He came to let me know that he appreciated what we had done for him.

It was a surreal moment. The young man wasn’t in agony, and he seemed to be at peace with the inevitability of his death. However, I was caught unprepared. Since I wasn't sure how to respond, I simply acknowledged his words with a "thank you." We shook hands and he departed. That was the last time I saw him.

Last week, a colleague of mine sent out an email to a small number of his professional associates. He told us that he is very ill. Clearly, his implicit message was that he might never see us again. 

As I reflected on his message, I felt unprepared again. I wondered how I should respond. How would I say goodbye? Should I even broach the topic? This might be my only chance to let him know that I'd always considered him a mentor. But would he become despondent if I appeared to eulogize him? Would it be hurtful to express my sadness that we might never speak again?

I certainly didn’t want to add to his suffering. Perhaps I should ignore the gravity of his illness and focus on how I hoped he would recover soon.

But that would be dishonest. He is a physician, too, and always modeled treating his patients with empathy and compassion This was the part of his character that I felt most drawn to. He is a doctor who healed as much by listening to his patients than by any other therapy.

Asking the Right Questions

I decided to tell my friend what an important role model he has been for me, but I also had a question for him. Having treated many terminally ill patients, I have learned that most people who are dying have hopes for themselves, as well as the loved ones they are leaving behind. Therefore, I asked my physician friend whether he had any hopes he wanted to share with me. He told me he had two wishes.

“As I have been reflecting upon my personal and professional life, my first hope is that my presence really made a positive difference in people's lives. That would be my legacy. The outpouring of affection, goodwill and positive comments that I have received from ex-patients, friends, family and colleagues has made it clear that I have succeeded in that,” he said.

My friend also expressed his hope for a change in our political situation. He mentioned the anger, frustration and hopelessness he feels watching American society fall into two warring ideological camps. His hope is that the young people of today will lead us into a better future.

Opportunities for Closure

COVID-19 has forced me to think about the reality that death can catch any of us by surprise.

As I write this, we are in the midst of a pandemic that has infected more than 17 million people and taken more than 680,000 lives worldwide. Many of the COVID-19 victims died alone and didn't get a chance to say goodbye to their loved ones.

Even in ordinary times, most of us don't get to say goodbye. We often deny the reality of death as life draws to a close. "You'll feel better soon," we say, either to make ourselves feel better or to avoid the topic. Even when we are allowed to be at the bedside of someone who is dying, we often lack the courage to convey our true feelings. Honesty can be too painful during those moments.

I remember saying goodbye to my dying father. Lying with him on his bed in his home, I asked my father if he was afraid. Many of us refrain from expressing grief at moments like that, because we worry that we might make the dying person feel worse. But I could not keep from crying.

In The Four Things That Matter Most, author Ira Byock, MD, identifies the messages he considers most important to communicate to loved ones near the end of life: “Please forgive me. I forgive you. Thank you. I love you.” Expressing these sentiments can help create a sense of mutual peace and completion.

Saying goodbye does not wish death on anyone. It acknowledges the richness of the relationship that has been. That is what I felt when I told my dad I loved him, which at the time was my way of saying goodbye. It is also how I felt when I brought closure to the relationship with my friend who emailed me.

Congressman John Lewis, the noted civil rights leader, expressed hope for the future in a New York Times op-ed published shortly after his July 17th death. He said, “Though I am gone, I urge you to answer the highest calling of your heart and stand up for what you truly believe.”

Perhaps we should consider following Lewis's example. By daring to acknowledge what is happening and to say goodbye, we are bravely addressing the highest calling of our hearts. We also have the opportunity to honor all those who touched us and made us who we are.

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

Former VP of Genetic Test Company Pleads Guilty to Paying Doctors Illegal Kickbacks

By Pat Anson, PNN Editor

The former vice-president of marketing for a controversial genetic testing company has pleaded guilty in federal court to paying physicians millions of dollars in illegal kickbacks to order genetic tests for Medicare patients.

Donald Matthews, who was Vice President of Market Development for Proove Biosciences, pleaded guilty this week in federal court. Matthews faces up to 5 years in prison and a $250,000 fine when he’s sentenced in October.

Proove filed for bankruptcy in 2017 after its headquarters in Irvine, California was raided by FBI agents. The company specialized in DNA testing that supposedly identified whether a patient is at risk of opioid addiction and what medications would best treat their pain. Proove said its tests, which cost thousands of dollars, were proven effective in peer-reviewed clinical studies, but a genetic expert told STAT News the studies were “hogwash.”

According to Matthews’ plea agreement, Proove paid doctors at least $3.5 million to induce them to order DNA tests for their patients.  The company then billed Medicare approximately $45 million to pay for the tests and received about $21 million in unlawful payments.

“Proove concealed the true nature of the kickbacks by falsely characterizing the payments as compensation for participating in a clinical research program sponsored by Proove,” the U.S. Attorney’s Office in San Diego said in a statement. “In furtherance of the scheme, Proove placed its own employees in doctors’ offices.  The Proove employees collected a cheek swab and completed most of the paperwork associated with the ‘clinical research’ program.”

Prosecutors say Proove paid kickbacks to an undisclosed number of doctors throughout the country, with the payments tied to how many DNA tests that a doctor ordered. When doctors complained about delayed or reduced payments, a Proove executive demanded that they increase their testing volume. 

“Kickbacks corrupt the medical judgment of physicians, generate unnecessary tests and treatments, increase health care costs, and create unfair competition,” said U.S. Attorney Robert Brewer.

‘A Waste of Time and Money’

As PNN has reported, a non-profit healthcare system in Great Falls, Montana had a Proove “patient engagement representative” employed on site at the Benefis Pain Management Center.

“We had a meeting one day and here are these people from Proove Biosciences. They told us they were doing a research project,” said Rodney Lutes, a physician assistant who was later fired by Benefis. “They wanted to come to Benefis, into the pain department, and test our patients.  We were told this would be at no cost to the patient. My understanding was that they weren’t going to charge anybody, but I found out afterwards they were charging insurance companies.

“They said providers who participated in this would get some form of payment for participating in the program and for filling out all the paperwork.”

Lutes’ supervising physician at the clinic was Katrina Lewis, MD, a pain management specialist at Benefis who was on Proove’s Medical Advisory Board. Benefis has denied that Lewis or any of its employees received kickbacks from Proove for referring business to them. The clinic also said the DNA tests were voluntary and only done on patients if they were appropriate.

 A copy of the clinic’s opioid policy obtained by PNN indicates the tests were mandatory for some patients.

“All patients on dosing levels at or higher than the maximum policy dose MUST be submitted for genetic testing,” the policy states.  

Proove had two types of tests for patients in pain management, an “Opioid Risk Test” and an “Opioid Risk Profile.” According to Proove, the tests could determine a patient’s risk of abusing pain medication.

A Benefis patient who took the tests said they were “a waste of time and money.”

“The meds it said I should be taking either didn’t work, stopped working, or made me sick. And the meds I should not be taking I do just fine on,” she told PNN.

Stem Cell Osteoarthritis Studies Advance

By Pat Anson, PNN Editor

A Canadian doctor is recruiting patients for a "first of its kind" stem cell research project for osteoarthritis. The Phase II study could further advance the use of regenerative medicine in treating osteoarthritis, a joint disease for which treatment options are currently limited to pain medication, steroid injections or joint replacement surgery.

"This is a potential game changer in the management of osteoarthritis," says lead investigator Dr. Grant Pagdin.  "Evidence is building that regenerative procedures using the combination of biologic materials we are investigating here have the potential to reduce joint pain and improve function.” 

Pagdin is recruiting 255 Canadians with osteoarthritis from 19 to 79 years of age. The purpose of the study is to demonstrate the effectiveness of combining platelet-rich plasma (PRP) derived from a patient’s own blood with stem cells derived from their body fat (adipose tissue) or bone marrow.  

Participants will be randomly assigned to one of three groups that will receive injections of PRP and adipose stem cells, PRP and bone marrow stem cells, or PRP with both types of stem cells. Three injections of the biologic material will be made into an arthritic joint. Participants will then be followed for up to 24 months to see which treatment worked better

Meanwhile, a California stem cell company has announced that enrollment has officially ended for a similar study of stem cells. Thirty-eight patients with knee osteoarthritis have been recruited by Personalized Stem Cells (PSC) for a Phase I trial to have adipose stem cells injected into one knee. The study was originally set to have up to 125 patients, but was scaled back due to COVID-19 concerns.

"While stem cells have previously been used successfully in the treatment of osteoarthritis, our goal is to produce high quality data and ultimately receive FDA approval so that arthritic patients have access to PSC's quality tested stem cell treatments," Dr. Robert Harman, PSC’s CEO, said in a statement.

PSC hopes to submit results from the study to the FDA by the end of 2020, after which a Phase II blinded, placebo-controlled study will be launched.

In addition to the osteoarthritis knee study, PSC recently received FDA approval to launch a small clinical trial for the treatment of COVID-19 patients with stem cells. The company also plans to pursue FDA approval of stem cells for the treatment of back pain and traumatic brain injuries, as well as arthritis affecting other joints.

A small Phase II clinical trial recently found a single injection of adipose stem cells 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.

More than 27 million Americans live with osteoarthritis, a progressive condition caused by the breakdown of joint cartilage. Osteoarthritis causes pain, physical disability, lower quality of life, and is associated with early death and cardiovascular problems.

10 Ways To Survive Home Isolation

By Barby Ingle, PNN Columnist

On November 2nd last year, I fell very ill. It was a Saturday evening. I was fine and then I was having trouble breathing. Two days later I was diagnosed with pneumonia and on the 18th I was told that I had Valley Fever.

My immune system is already weak due to multiple chronic conditions, and catching any kind of acute cold or flu is life-threatening for me. I was put on a breathing machine, which was new for me, and advised to stay home to avoid further infections.

Being homebound is something I have been doing for a very long time. By the time Covid-19 struck and a push for social and physical distancing began, I had already been isolated for years and ultra-isolated since November. I still have Valley Fever symptoms, which are similar to coronavirus, and still have a mass on my upper right lung. I have tested negative for both Covid-19 and its antibodies.

Now that being physically isolated is a thing, many are asking me for advice on what to do or how to make it through self-quarantine. Spending so much time at home, I’ve found that I have a lot of energy and have to turn to other activities to keep my spirits up. These are what I’ve come up with.

1. Catch up on reading: Not everyone is ready to write a book, but reading one is something most of us can do. Expand your mind and educational knowledge by reading about subjects that have interested you and would like to learn more about.

2. Dance party for one: It doesn’t matter if you can dance or not, no one is watching! Just put on some music and move your body. Movement can help circulate blood, increase endorphins and improve your mood. I always love a good spontaneous dance party!

3. Games on your phone: For this you need a smart phone. My personal games are the free apps that keep my mind working. I like Solitaire, Drop the Number, Pull the Pin and Woodoku.

4. Netflix: I never saw the need for Netflix until I had it. When people reached out and asked what they could do to help, this was one of the tools someone set us up with. We have watched more TV shows in the last 9 months than the previous 5 years. Everything from great dramas like Ozark and The 100, to comedies like You’re Dead To Me, Shameless and Happy! I’ve also enjoyed reality shows such as 100 Humans, Alone and Naked and Afraid.

5. Organize your medical records: For those of you who have thick case file like me, what better time to order and organize your medical records? You can also address any mistakes in those records and be better prepared for future care by staying organized.

6. Social media: We may be physically distant, but socially we can still be engaged. When I am up to it, I post updates. I’ve also been sharing messages and articles a lot more since I am not creating as much content during this period. I believe my followers like it and I know the people I share appreciate it as well.

7. Start a gratitude journal: Isolation can lead to negative feelings, such as being scared, anxious, mad and sad. This can have an impact on you and your loved ones. Taking the time to write a gratitude list of the positive things in your life and the things you can still do (even if it is just taking a shower) can be a good tool for keeping a positive attitude. A gratitude journal can also be something you look back on to help see all the good in your life, even in the toughest of times.

8. Start a new project: You could learn a new hobby, craft or language, or develop your appreciation for art. They say 21 days of something will improve your skills. When will you ever have this much time to do something, even if it is just a little each day?  

9. Interview family members: With the passing of all of my grandparents and parents in recent years, I wished I had done a legacy video with each of them. I asked my mother-in-law do an interview with me and turned it into a Christmas present for both of her boys and our nephews. It’s a great way to get a living picture that is enduring, long past the time we are here on earth. It also gives us more social contact with the older members of the family.

10. Rest! This one is the best for me. Because of how tired I am, I give myself permission to rest as much as possible and get nothing much done. My days are filled with resting and relaxing most of the time. There is no pressure or stress to do it any other way.

Do you have other ideas on how to survive isolation and stay engaged with the world?  Please share your thoughts in the comment section below.

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