Neanderthal Gene Makes Us More Sensitive to Pain

By Pat Anson, PNN Editor

The popular image of Neanderthals is that they were brutish and primitive hunter-gatherers who scratched out an existence in Eurasia 500,000 years ago. That may be a bit unfair. Anthropologists say Neanderthals were more intelligent than we give them credit for, lived socially in clans, and took care of each other. They also co-existed for tens of thousands of years with modern humans, competing for food and sometimes interbreeding before the Neanderthals were driven to extinction.

Neanderthals may have had the last laugh though, because we’ve inherited a gene from them that makes some of us more sensitive to pain, according to a new study published in the journal Current Biology. The gene affects the ion channel in peripheral nerve cells that send pain signals to the brain.

“The Neandertal variant of the ion channel carries three amino acid differences to the common, ‘modern’ variant,” explains lead author Hugo Zeberg, a researcher at the Max Planck Institute for Evolutionary Anthropology in Germany. “While single amino acid substitutions do not affect the function of the ion channel, the full Neandertal variant carrying three amino acid substitutions leads to heightened pain sensitivity in present-day people.”

Zeberg and his colleagues say about 40% of people in South America and Central America have inherited the Neanderthal gene, along with about 10% of people in East Asia. Using genetic data from a large population study in the UK, they estimate that only about 0.4% of present-day Britons have the full Neanderthal variation of that specific gene.

“The biggest factor for how much pain people report is their age. But carrying the Neandertal variant of the ion channel makes you experience more pain similar to if you were eight years older,” said Zeberg.

The Neanderthal ion channel in peripheral nerves is more easily activated by pain, which may explain why modern-day people who inherited it have a lower pain threshold. Exactly how the gene variation affected Neanderthals back in the day is unknown.

“Whether Neandertals experienced more pain is difficult to say because pain is also modulated both in the spinal cord and in the brain,” said co-author Svante Pääbo. “But this work shows that their threshold for initiating pain impulses was lower than in most present-day humans.”

It’s possible the heightened sensitivity to pain acted as an early warning system for Neanderthals, alerting them to injuries and illnesses that needed attention. Neanderthals lived a hard life. About 80% of Neanderthal remains show signs of major trauma from which they recovered, including attacks by bears, wolves and other large animals.

Neanderthals made extensive use of medicinal plants. The remains of a Neanderthal man in Spain with a painful tooth abscess showed signs that he chewed poplar tree bark, which contains salicylic acid, the active ingredient in aspirin.  

‘First, Do No Harm’ Doesn’t Mean ‘No Rx Opioids’

By Dr. Lynn Webster, PNN Columnist

Many physicians say their ethical duty is to "First, do no harm." This principle is often mentioned in the context of prescribing opioids. Some people even believe that prescribing opioids to treat people in pain violates the Hippocratic Oath, because, they say, a doctor’s first obligation is not to do anything that could make things worse for a patient.

However, that is a flawed oversimplification of the "First, do no harm" directive.

As N.S. Gill writes in Thoughtco, many people believe that “First, do no harm” is a quotation from the Hippocratic Oath. They are mistaken. More importantly, the creed does not say that doctors must never provide a clinical intervention that might trigger some degree of harm. If physicians had to live by such a code of ethics, they would be unable to offer almost any medical treatment, since they all carry some risk of harm.

As the Harvard Health Blog points out, ensuring that you always "do no harm" would mean no one would ever have lifesaving surgery. Doctors wouldn’t be able to order CT scans, MRIs, mammograms, biopsies or other tests that can turn up false positives; draw blood for fear of bruising or provide vaccines that may cause side effects. Even aspirin is a potentially dangerous treatment for some people. To avoid risk altogether, doctors would have to limit themselves to Band-aids and soothing words.

The Double Effect Philosophy 

“First, do no harm” isn’t about standing by helplessly while someone suffers needlessly. It is an ideal that is better explained by the principles embedded in the philosophy of the Double Effect. 

According to the Stanford Encyclopedia of Philosophy, the Double Effect doctrine means that an action is acceptable if harm occurs in the course of trying to make a positive difference. An intent to do good or help must be the underlying motive. However, the intention to do good by itself is insufficient. The possible good from the action must sufficiently outweigh the potential for harm. 

Often, the Double Effect guideline is used to explain why physicians prescribe opioids even knowing they can pose risk to patients. Doctors prescribe opioids -- sometimes at very high doses -- with the intent to relieve pain (which is “to do good”), because there are few other options available or affordable, and the risk of harm is manageable for most patients. 

This trade-off in decision-making is true for all medications and interventions, not just for opioids. Opioids are not evil agents, despite their checkered reputation among some laypeople, physicians and lawmakers. 

Not Using Opioids Can Causer Harm

Most patients nearing the end of their lives, their families and clinicians who treat terminally ill patients place a priority on a peaceful, pain-free death. Opioids are frequently necessary to fulfill that desire, despite their potential to hasten death. 

Providing opioids to ease end-of-life suffering passes the Double Effect test, but it is still controversial. Furthermore, end-of-life-care is only one area for which some experts question the use of opioids. Some people believe that opioids should never be prescribed because of the harm they may cause, regardless of their potential benefits to patients. 

But not using opioids can also cause harm. In an American Journal of Law and Medicine scholarly essay this month, Kate Nicholson and Deborah Hillman argue that there is a special duty to a subgroup of patients who are already receiving opioids: doctors must not harm them with forced tapering.  

There is also harm, Nicholson and Hillman say, in not treating pain in patients. Based on a Human Rights Watch study, they believe that doctors who deny patients the care they need "in an effort to protect their licenses or stay under the radar of law enforcement" may be violating their patients' human rights. 

Nicholson and Hillman point out that "First, do not harm" has a different meaning for policymakers than for physicians. Policymakers have a responsibility to ensure that society isn't harmed by opioids. However, the authors contend that policymakers have an even greater duty to "do no harm" by respecting the doctor/patient relationship when considering the societal impact of opioid prescribing.  

The patient's need for pain medication, they believe, should be prioritized over society's need for protection against the harm that misused or diverted opioids can cause. 

Our Ethical Responsibility to Patients 

As physicians, we are trained to heal. We become healthcare professionals because we want to provide compassionate care to the sick, the frail, and the dying. We swear an oath to use our best judgment to evaluate the risks and potential benefits in all interventions. Intending to do good, even knowing that adverse effects can occur with every intervention, is our ethical responsibility. 

A mischaracterization of the phrase “First, do no harm” must not prevent providers from caring for people, or prevent policymakers from allowing physicians to treat their patients. That treatment must include providing patients with medication that can adequately provide pain relief with acceptable risk.  

The physician's ethos must always be based on what is best for the patient when all factors are considered -- not on arbitrary guidelines that impose a one-size-fits-all philosophy.  

This column has been revised and updated from a version that appeared in the Salt Lake Tribune on December 10, 2017.

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

CDC Appoints New Opioid Workgroup for Guideline Update

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has named a diverse group of physicians, academics and patients to an “Opioid Workgroup” that will advise the agency as it works on an update and possible expansion of its controversial opioid prescribing guideline. Several advisors on the 23-member workgroup also advised the agency during the 2015-2016 guideline process.

Notably lacking on the new panel are any members of Physicians for Responsible Opioid Prescribing (PROP), a small but influential group of radical anti-opioid activists who played an outsized role in drafting the original guideline.

Although voluntary and only intended for primary care physicians treating chronic pain, the guideline’s recommended limits on opioid prescribing were quickly adopted as policy by other federal agencies, dozens of states, insurers, pharmacies and doctors of all specialties.  As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses, leading to uncontrolled pain, withdrawal and, in some cases, suicide.

Not until last year did the CDC publicly acknowledge the “misapplication” of the guideline and promise to make changes – although the process is unfolding slowly. An update to the guideline is not expected until late 2021, nearly six years after the initial guideline was released. It is expected to include new recommendations for the treatment of acute, short-term pain.  

‘Opioids Gave Me a Life’

There are two pain patients in the workgroup, who have contrasting experiences with opioid medication.

One is Kate Nicholson, a civil rights lawyer and patient advocate who took opioids for several years while disabled with severe back pain. Nicholson declined to talk with this reporter about her appointment to the workgroup, but shared her personal experience with the medical use of opioids in a 2017 PNN guest column.

“As soon as I took opioids, I improved. I wasn’t foggy or especially euphoric. In fact, the opposite happened, space opened in my mind and I could work again.  I also never developed a tolerance, requiring more medication for the same level of pain relief,” Nicholson wrote. “Opioids did not heal me. Integrative treatment over a long period of time did.  But opioids gave me a life until I could find my way to healing. Importantly, they allowed me to continue to work.”  

In a 2019 op/ed in The Los Angeles Times, Nicholson said the CDC guidelines should be revised because they were being treated  as “one-size-fits-all mandates” that were harmful to patients.

“The agency needs to revise its guidelines to recommend that physicians not abandon pain patients or engage in ‘forced tapering.’ The CDC should also study and address any unintended consequences of its 2016 guidelines, as it promised to do,” she wrote.

The other patient on the panel is Travis Rieder, PhD, Director of the Bioethics Masters Program at Johns Hopkins University. Rieder severely injured his foot in a motorcycle accident in 2015 and became dependent on opioids while recovering from surgery.

Rieder has written a book and several articles on his experience with chronic pain and the difficulty he had getting off opioids. He also became frustrated with the healthcare system and how it often abandons patients to pain, addiction or both.

“I represented one of the medical community’s most distressing dilemmas: a patient in obvious severe pain but begging for medication that is killing tens of thousands of people a year. The fact that different doctors, in different moments, treated me in radically different ways is completely unsurprising. Because no amount of public hand-wringing or blunt policy tools is going to make it clear what to do with patients like me. We’re a problem, and there’s no obvious solution,” Rieder wrote in his book, “In Pain: A Bioethicist’s Personal Struggle with Opioids.”

‘Clear Need’ for More Specific Guidelines

The other 18 members of the workgroup bring a mix of mostly academic and medical experience to the table.

At least five members of the panel advised the CDC during the drafting the 2016 guideline. They include the chair of the workgroup, Christina Porucznik, PhD, a professor of public health at the University of Utah, who chaired the opioid workgroup in 2016. Chinazo Cunningham, MD, Anne Burns, RPh, and Mark Wallace, MD, are also returning members of the workgroup. They are joined by Jeanmarie Perrone, MD, was a peer reviewer for the 2016 guideline.

In 2018, Perrone called for even more prescribing guidelines.

“There is a clear need for further impactful guidelines similar to the CDC guidelines that outline more specific opioid and non-opioid prescribing by diagnosis," said Perrone, a professor of Emergency Medicine and director of Medical Toxicology at Penn Medicine.

A new addition to the workgroup is Beth Darnall, PhD, a pain psychologist at Stanford University, who has drawn some controversy in the pain community for her studies about “catastrophizing” — a clinical term used to describe patients who are anxious, angry or feel helpless about their pain. She recently began an effort to find another term for catastrophizing.

Darnall, who has advocated against forced opioid tapering, expressed concern about the misapplication of the CDC guideline in a 2019 op/ed published by The Hill.

“Health-care organizations and states have cited the CDC guideline as a basis for policies and laws that extend well beyond its intended purpose. The guideline has been wrongly cited to substantiate proposed dose-based opioid prescribing policies that fail to account for the medical circumstances of the individual patient,” wrote Darnall. “We need flexible policies that provide meaningful access to comprehensive pain care and do not myopically focus on opioid dose reduction policies.”

‘Vast Improvement’ Over Previous Workgroup

The fact that we even know who is on the new workgroup is a small step forward in transparency for the CDC, which refused to disclose the names of any of its advisors when a draft version of the opioid guideline was released in 2015.

Only when threatened with a lawsuit and a congressional investigation did the CDC make the names public. They included Dr. Jane Ballantyne, President of PROP, along with PROP board members Dr. Gary Franklin and Dr. David Tauben. PROP founder and Executive Director Dr. Andrew Kolodny and PROP member Dr. David Juurlink also participated in a “Stakeholder Review Group” for the CDC.

“This group is a vast improvement over the 2016 Guideline group. There are several people here who I know, and who I trust to act as strong patient advocates,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management. “All in all, this is a much better panel, and I'm confident it will produce a much better result for people with pain.”

Twillman cited Burns, Darnall, Wallace and Christine Goertz as workgroup members who would “keep patients in the center of the discussion.”

“The only other member I really know is Jeanmarie Perrone, who, while not a member of PROP, certainly could be. She and I have shared presentation opportunities a couple of times before, and she is very much in the anti-opioid crowd,” said Twillman.

“The new Workgroup constitutes a major improvement over the workgroup involved in drafting the 2016 guideline. That group included a number of well-connected people passionately opposed to the use of opioids in management of chronic pain,” said Stephen Nadeau, MD, a professor of Neurology at the University of Florida College of Medicine.

“Although the new Workgroup membership does not include such people, one could well question the inclusion of several people academically invested in pharmacological or non-pharmacological alternatives to opioid treatment, particularly in the complete absence of comparative effectiveness studies of such treatments.  One could also question the inclusion of surgeons, emergency room physicians, and pharmacists, who do not manage chronic pain.”

More Stakeholders Sought

CDC is seeking additional input from pain patients, caretakers and healthcare providers who will serve as “stakeholders” during the guideline development process. The agency is planning to speak with 100 stakeholders by phone or online for 45-60 minutes “to listen to personal perspectives and experience” related to pain care. The CDC has already obtained written comments from nearly 5,400 people, most of them pain patients.

If you’re interested in being a stakeholder, further information can be found here. The CDC is taking applications until August 21.

The CDC has also funded a series of new studies on opioid and non-opioid treatments for chronic pain. The report on opioids was released in April by the Agency for Healthcare Research and Quality. It concluded that opioids were no more effective in treating pain than nonopioid medication, and that long-term use of opioids increases the risk of abuse, addiction and overdose. At least three PROP members served as experts and peer reviewers during the drafting of that report.

FDA Approves Capsaicin Patch as Treatment for Diabetic Neuropathy

By Pat Anson, PNN Editor

Millions of patients with diabetic peripheral neuropathy live with burning or stinging pain in their hands and feet. In what could be called a case of fighting fire with fire, the U.S. Food and Drug Administration has approved the first use of a medicated patch made with capsaicin – the spicy substance that makes chili peppers hot – as a treatment for diabetic neuropathy.

The Qutenza skin patch is made by Grünenthal and contains 8% capsaicin, which acts on pain receptors in the skin by desensitizing and numbing nerve endings.

“Pain associated with diabetic neuropathy is an extremely challenging condition to diagnose, treat and manage effectively, which has a significant quality of life impact for many patients,” said David Simpson, MD, a Professor of Neurology at the Icahn School of Medicine. “In addition, patients are dissatisfied with unresolved pain and the side effects associated with current systemic treatments.”

A 2015 study found that Qutenza worked faster than pregabalin (Lyrica) in treating neuropathic pain, providing relief in 7.5 days, compared to an average of 36 days in patients taking pregabalin. Patients who used Qutenza were also more satisfied with their treatment and had fewer side effects.

That same year the European Commission approved Qutenza as a treatment for diabetic neuropathy, but it took another five years for the FDA to give its approval for the same condition. The patch was initially approved by the FDA in 2009 for treating post-herpetic neuralgia, a complication from shingles.

“Painful diabetic peripheral neuropathy has a significant impact on the day-to-day lives of millions of individuals, and we believe Qutenza can be a much-needed non-opioid treatment option for these patients,” Jan Adams, Grünenthal’s Chief Scientific Officer, said in a statement. “This expanded indication of Qutenza in the U.S. is an exciting milestone in our efforts to make Qutenza available to even more patients in need worldwide.”  

A big catch is that the patch shouldn’t be applied at home and should only be used sparingly. According to its warning label, Qutenza should be applied by a doctor or healthcare professional, who should be wearing a face mask and gloves to protect themselves in a well-ventilated area. Up to four patches can be applied on the feet for up to 30 minutes, a procedure that can be repeated every three months. The most common side effects are redness, itching and irritation of the skin where the patch is applied.

Qutenza has gotten mixed reviews from patients, who warned that capsaicin can cause painful burning sensations.

“Qutenza really does work. I did have very intense burning,” a patient posted in a review on Drugs.com. “The pain can be mind blowing but it does subside and a cool fan helps. Don't let your pets near the area as it will burn them. I have had multiple Qutenza and… it lasts up to 3 months plus. Don't apply yourselves. Use a health professional as it does burn.”

“Although I was informed about this treatment and how your body might react to it, my case spiraled out of hands,” another patient wrote. “The medics had to call a team to manage my situation. The pain was so much that without a shred of doubt words simply can not explain.”

Diabetic neuropathy is a progressive and debilitating complication of diabetes that affects more than 5 million Americans. Patients typically experience numbness, tingling or stabbing sensations in their hands and feet. More severe cases can result in foot ulcers, amputations and other complications.

How Public Health Failed to Stop Coronavirus Pandemic

By Roger Chriss, PNN Columnist

The pandemic is not going well in the United States, except possibly for the coronavirus. The U.S. is seeing record levels of new confirmed cases, and deaths are back up to almost 1,000 daily. Projections based on positivity rates and hospitalization levels suggest a long summer of illness and death, followed by even more in the autumn.

Several websites are using COVID-19 data to compile visual “dashboards” of what’s happening in states and counties around the nation.

Covid Act Now classifies most of the South as having an “active or imminent outbreak,” while the Covid Exit Strategy marks the entire South and much of the West as having “uncontrolled spread.”

Axios summarizes the nation’s response to COVID-19 with the headline “We blew it.”

“America spent the spring building a bridge to August, spending trillions and shutting down major parts of society. The expanse was to be a bent coronavirus curve, and the other side some semblance of normal, where kids would go to school and their parents to work,” wrote co-authors Dan Primack and Nicholas Johnson.

“The bottom line: We blew it, building a pier instead.”

COVID EXit STRATEGY

The bleak situation is clearly visible in county-level maps of the country. The Harvard Global Health Institute’s Covid dashboard marks almost all of Florida red. Most counties in the South are also red, and only a handful of counties around the nation are green.

The STAT News preparedness dashboard shows that many counties, particularly in the South and West, are completely unprepared to handle a surge of Covid-19 cases.

Despite all this, there is no nationally coordinated response. As Prevent Pandemics notes in a new report, the U.S. has no standards for collecting and reporting local or national data on COVID-19. As a result, the information is “inconsistent, incomplete and inaccessible in most locations.”

“Particularly in the absence of a clear national vision, strategy, leadership, or organization, it is crucial to establish standardized, timely, accurate, interlinked, comparable, and informative dashboards for every state and county in the US. This is required to improving our control of the virus and maximizing our chance to get our children to school in the fall, ourselves back to work, our economy restarted, and to prevent tens of thousands of deaths,” the report concludes.

The Trump administration has handed over management of Covid-19 to states, as if the virus confines itself within state borders or mutates when crossing them. The White House and some governors have even blamed the current surge on increased testing, though this is mathematically impossible, according to STAT News.

Cities and states are also competing against each other for scarce medical resources like N95 masks and drugs like remdesivir, and disagreeing about public health measures like face coverings and quarantining visitors from hard-hit areas.

Waiting for a Vaccine

The pandemic response in the US seems to be to soldier through until a vaccine becomes available. There is rapid progress with vaccine development, including promising results in Phase I trials from Moderna, Oxford-AstraZeneca, and CanSino. Phase III trials are getting underway, meaning that data should be available by year’s end. If all goes extremely well, large-scale deployment of one or more vaccines could be underway by summer, 2021.

But the coronavirus is well underway now. The Covid Tracking Project shows testing, cases and hospitalizations surging upward week after week, with deaths expected to follow.

The virus is spreading fast enough that the U.S. could reach herd immunity levels before widespread deployment of a vaccine. This means hundreds of millions of Americans exposed. Even if the rate of serious illness is only 5% and of death is 0.5%, that is still millions of people affected.

Johns Hopkins reports the U.S. has the third highest death rate in the world, behind only the United Kingdom and Chile.

The pandemic will keep going until we stop it. As journalist Debora Mackenzie notes in the book, Covid-19: The Pandemic That Never Should Have Happened: “Science didn’t actually fail us. The ability of governments to act on it, together, did.”

The U.S. has indeed failed and will continue to fail until it develops a coherent public health strategy.

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. 

U.S. Pain Foundation Pockets $210,000 from Insys Therapeutics

By Pat Anson, PNN Editor

The U.S. Pain Foundation has decided to keep over $210,000 leftover from a controversial co-pay prescription drug program funded by Insys Therapeutics, a disgraced Arizona drug maker blamed for the overdose deaths of hundreds of pain patients.

The funds have been designated as “unrestricted grant revenue” by the Connecticut based-charity, which at one time claimed to be the nation’s largest non-profit advocacy group for pain patients. The decision to keep the money, which was being held in an escrow account, reverses a previous pledge by U.S. Pain in 2018 that it “will not accept funding from Insys going forward.”

“It has been determined that the funds may be used for charitable purposes consistent with the tax-exempt purpose of USPF in assisting people living with chronic pain. Going forward these funds will be allocated for such purposes,” U.S. Pain disclosed in a recent audit statement. “The escrow reserve of $210,974 was reversed in 2019 and the unrestricted funds were recorded as unrestricted grant revenue.”

Insys and U.S. Pain launched the “Gain Against Pain” program in 2016 with $2.5 million donated by the company. The stated goal of the co-pay program, which was administered by NeedyMeds, was to help patients obtain medication for breakthrough cancer pain.

But the program was apparently only used to generate prescriptions for Subsys, an expensive and potent fentanyl spray that was Insys’ flagship product. A four-day supply of Subsys can cost nearly $24,000.

The Gain Against Pain program was shut down in 2018 after Insys executives were charged with racketeering, fraud, bribery and other criminal charges over their marketing of Subsys. Insys filed for bankruptcy in 2019 and its founder sentenced to 66 months in prison.

Controversy over the co-pay program and other financial irregularities also led to the resignation of Paul Gileno, the founder and CEO of U.S. Pain. Gileno later pleaded guilty to charges of fraud and tax evasion, and served a few months in federal prison.

“We now know that Insys Therapeutics advanced this program using predatory practices and were assisted in doing so by U.S. Pain Foundation via access to the vulnerable populations served by that organization,” said Stefanie Lee Berardi, a patient advocate and grant writer who worked in nonprofit management.

“Nonprofits receiving large charitable donations have a duty to ensure the source of those funds is both legal and ethical before those funds are accepted. Once the funds are accepted, it is very difficult to give those funds back.”

The $210,000 in leftover co-pay funds would be a significant amount of money for most charities. U.S. Pain had over $1.4 million in revenue according to its 2019 tax return, about 30% less than the year before. The charity also disclosed in its audit statement that it received $92,805 this year from the federal government’s Payroll Protection Loan Program.

Questionable Spending

Under Gileno’s leadership, there was virtually no oversight of spending at U.S. Pain, which used donated funds to pay for highly questionable purposes, such as operating a money-losing bakery, loans to Gileno’s brothers and a family vacation to Universal Studios in Florida. The charity now has a chief financial officer and a new board of directors, and says it has other safeguards in place to prevent further fraud.

U.S. Pain CEO Nicole Hemmenway, who was vice-president and board chair under Gileno, did not respond to a request for comment for this story.

The charity’s audit statement indicates the $210,974 was received in two checks from NeedyMeds and had not been spent or earmarked for any program. Classifying the funds as unrestricted grant revenue means they can be used for any purpose – not just helping cancer patients.

“What I am really not understanding is why U.S. Pain chose to accept these as unrestricted funds, rather than to a restricted fund that would help individuals and families who were harmed by Insys’ co-pay program,” Berardi said in an email.

“Given that they haven’t yet done so, it is now imperative that they clearly define how those monies will be used. It is still possible for them to do the right thing. Should they choose to, they may find that they can mitigate the reputational harm sustained as a result of unethical and illegal business practices for which their CEO went to prison and an irresponsible board of directors who failed to meet their duty of care.”

Another critic believes U.S. Pain should donate the money to another charity.

“Given what has come out about both Insys and the U.S. Pain Foundation, the ethical thing to do would have been to give the money to a nonprofit organization that provides treatment for opioid use disorder,” said Adriane Fugh-Berman, MD, Director of PharmedOUT, a program at Georgetown University that seeks to expose deceptive marketing in the healthcare industry.

Co-pay prescription drug programs – also known as co-pay charities – are ostensibly designed to help needy patients pay for prescription drugs. But in recent years, several major pharmaceutical companies have paid heavy fines to settle fraud allegations that they used co-pay programs to steer Medicare patients to their high-priced drugs.

The assistance programs typically pay only a small amount for the prescriptions, with the rest of the cost picked up by Medicare. Federal anti-kickback laws prohibit drug companies from making any kind of payment to induce Medicare patients to purchase their drugs.

Good Attitude Improves Effectiveness of Yoga and Physical Therapy

By Pat Anson, PNN Editor

Yoga is a four-letter word for a lot of chronic pain patients, who are often urged to try yoga or physical therapy to ease their pain. Many pain sufferers believe exercise will only make their pain worse.

But a new study by researchers at Boston Medical University found that people with chronic lower back pain are more likely to benefit from yoga and physical therapy if they have a positive attitude about exercise.

The study involved 299 mostly low-income patients with chronic lower back pain who took weekly yoga classes or had physical therapy for 12 weeks. They were compared to a control group who had “self-care” – which consisted of reading a handbook on self-management strategies for back pain, such as stretching and strengthening exercises.

Nearly half (42%) of those who had yoga or physical therapy responded to the treatment, while only 23% of those in the self-care group had improvement in their pain and physical function.

Interestingly, participants who continued taking pain medication during the study were more likely to benefit from yoga (42%) than those who had physical therapy (34%) or self-care (11%).

"Adults living with chronic low back pain could benefit from a multi-disciplinary approach to treatment including yoga or physical therapy, especially when they are already using pain medication,' said lead author Eric Roseen, DC, a chiropractic physician at Boston Medical Center.

Another important finding from the study, which was published in the journal Pain Medicine, is the effect that “fear avoidance” can have on patient outcomes.

Among the participants who had less fear of exercise, 53 percent responded to yoga, 42 percent responded to physical therapy and 13 percent responded to self-care. In contrast, participants who had a high fear of exercise usually had a poor response, regardless of what therapy group they were in.  

Other factors that appeared to improve patient response were a high school education, higher income, employment and being a non-smoker.

"Focusing on a diverse population with an average income well below the U.S. median, this research adds important data for an understudied and often underserved population," said Roseen. "Our findings of predictors are consistent with existing research, also showing that lower socioeconomic status, multiple comorbidities, depression, and smoking are all associated with poor response to treatment."

It doesn’t take a lot of time to benefit from exercise. A 2017 study found that just 45 minutes of moderate physical activity a week improved pain and function in patients with osteoarthritis.

A few weeks of yoga significantly improved the health and mental well-being of people suffering from arthritis, according to a 2015 study at Johns Hopkins University.

Pilot Study Finds Cannabis Helpful in Treating Sickle Cell Pain

By Pat Anson, PNN Editor

Cannabis may be an effective way to reduce acute and chronic pain in patients with sickle cell disease, according to a small pilot study published in JAMA Network Open.

Sickle cell is a genetic disease that affects about 100,000 people in the U.S., mostly of African or Hispanic descent. Their red blood cells are rigid and sickle-shaped, which causes blockages in blood vessels, starves tissues and organs of oxygen, and causes periods of intense pain.

Researchers at UC Irvine and UC San Francisco enrolled 23 adult sickle cells patients in a placebo-controlled study to see if inhaled cannabis could be a safe adjunct to opioid medication in treating sickle cell pain. Most patients continued to use opioids during the course of the five-day trial. Participants inhaled either vaporized cannabis or a placebo three times a day. The cannabis had an equal ratio of CBD and THC – the psychoactive ingredient in cannabis.

As the five-day study period progressed, patients who inhaled cannabis reported that pain interfered less and less with their daily activities, such as walking and sleeping, and there was a significant drop in how much pain affected their mood. The decline in pain levels was not considered statistically significant, however.

Although the findings were mixed, researchers say their pilot study should pave the way to larger clinical studies of cannabis as a treatment for sickle cell pain.

"These trial results show that vaporized cannabis appears to be generally safe," said Kalpna Gupta, PhD, a professor of medicine at UCI Irvine's Center for the Study of Cannabis. "They also suggest that sickle cell patients may be able to mitigate their pain with cannabis—and that cannabis might help society address the public health crisis related to opioids. Of course, we still need larger studies with more participants to give us a better picture of how cannabis could benefit people with chronic pain."

Opioid medication has been the primary treatment for sickle cell pain. But with many physicians now reluctant to prescribe opioids due to fears of addiction, overdose and government prosecution, sickle cell patients have been left with fewer options.

“In the current climate of increased awareness of the ongoing opioid epidemic, it would have been encouraging if this study had demonstrated decreased use of chronic analgesics during the active cannabis vaporization phase,” researchers concluded. “Our study’s small sample size and short duration may have contributed to the inability to demonstrate decreased opioid use among participants receiving the active drug compared with the placebo.”

Of the 33 U.S. states that have legalized medical cannabis, only four have included sickle cell disease as a qualifying condition. That forces many sickle cell patients to obtain cannabis from unapproved sources.

"Pain causes many people to turn to cannabis and is, in fact, the top reason that people cite for seeking cannabis from dispensaries," Gupta said. "We don't know if all forms of cannabis products will have a similar effect on chronic pain. Vaporized cannabis, which we employed, may be safer than other forms because lower amounts reach the body's circulation. This trial opens the door for testing different forms of medical cannabis to treat chronic pain."

A recent small study in Israel found that very low “microdoses” of inhaled THC can significantly reduce chronic pain in patients with neuropathy, radiculopathy, phantom limb pain or Complex Regional Pain Syndrome (CRPS).

Honoring Black Pioneers in Medicine

By Dr. Lynn Webster, PNN Columnist

There have been countless Black pioneers in the medical profession, but few of us know their names or the contributions they made. This column acknowledges the impact these men and women have had on healthcare, despite the inequalities they faced in pursuing their vocations.

DR. JAMES MCCUNE SMITH

In 1837, James McCune Smith graduated from the University of Glasgow in Scotland, becoming the first African American to earn a medical degree.

Dr. Smith had been denied access to an American medical school, so he was forced to seek his medical career overseas. According to the University of Glasgow website, Smith was a noted abolitionist, educator, scholar and "one of the foremost intellectuals in 19th century America of any race."

Besides graduating at the top of his class, Smith was also the first Black to run a pharmacy in the United States.

In 1847, David Jones Peck became the first African American student to graduate from a U.S. medical school, receiving his degree from Rush Medical College in Chicago. 

Rebecca Lee Crumpler was the first Black woman to receive a degree from a medical school in America. That was in 1863.

Alexander Augusta was the first Black to be commissioned as a medical officer in the Union army during the Civil War. He was the "surgeon in charge" (in other words, the director) of the Contraband Hospital in Washington, DC.

Biddy Mason was a former slave not formally trained in medicine, but she helped deliver hundreds of babies as a midwife in Los Angeles in the 1860’s. Mason was also an entrepreneur and philanthropist, who donated generously to charity and helped establish the first black church in the city.

In 1879, Mary Mahoney was the first Black woman to be awarded a nursing degree. She is also credited as one of the first women in Boston to vote after the 19th Amendment was ratified.

Daniel Williams was one of the first physicians of any color to perform a successful open-heart surgery. In 1893, he opened Provident Hospital in Chicago, the first interracial and Black-owned hospital.

BIDDY MASON

In 1895, Robert Boyd co-founded the National Medical Association. This is the oldest and largest organization representing Black physicians and healthcare professionals in the United States. Dr. Boyd served as its first president.

Vivien Thomas, the grandson of a slave, worked as a laboratory assistant rather than as a doctor. Yet, in the 1940s, he created a surgical technique to correct the congenital heart malformation that causes blue baby syndrome. His white associate, Dr. Alfred Blalock, received the credit.

Charles R. Drew established large-scale blood banks at the beginning of World War II and saved thousands of lives. He also created the first bloodmobiles. The Charles R. Drew University of Medicine in Los Angeles is named after him. Over 80 percent of its students are from communities of color.

William Hinton, who received his medical degree from Harvard in 1912, was the first Black physician to teach at Harvard Medical School. He developed the Hinton test to diagnose syphilis and wrote Syphilis and Its Treatment, the first medical textbook published by a Black physician.

DR. RICHARD PAYNE

The world of doctors who specialize in pain management is small, because it is a relatively new specialty. That means only a limited number of Black physicians have focused on treating patients with pain in the modern era. Richard Payne was among those pain specialists.

In 2006, Payne was Professor Emeritus of Medicine and Divinity at Duke University Divinity School and held the John B. Francis Chair at the Center for Practical Bioethics. An internationally recognized expert in palliative care, Payne devoted his career to making palliative care standard practice for people with late-stage illness. He was the first African American to become president of the American Pain Society.

In 2019, Patrice Harris became the first African-American woman to be elected president of the American Medical Association. Dr. Harris has been chair of the AMA’s Opioid Task Force since its inception in 2014.

You may have heard some of these names before; others, you may be hearing for the first time. In any case, these men and women saved the lives of thousands of Americans at a time when racial discrimination was a legal, acceptable part of U.S. culture.

Skin Color Still Matters

We may tell ourselves that skin color no longer matters. We may take for granted the fact that the Black pioneers in healthcare laid the foundation for people of all races to be able to make their own contributions to the medical world. But recent history does not support that perspective.

In 2017, a white woman walked into a clinic in Ontario, Canada and demanded that a white doctor be found to treat her sick son. She was escorted out of the building by security and, presumably, continued her search for that elusive white doctor. The "Karen" video of the incident went viral.

Just this month in STAT News, Dr. Ruth Shim explained that she is leaving organized psychiatry because of its structural racism. She wrote about experiencing "countless microaggressions" as a Black leader in the psychiatric community. She also expressed her belief that the American Psychiatric Association seems to have unwritten policies to deliberately "impede progress toward achieving racial equity."

In another STAT News article last January, Uché Blackstock wrote about why Black doctors are leaving their jobs as faculty members at academic medical centers. Blackstock felt compelled to resign from her job because she "could no longer stand the lack of mentorship, promotion denial, and work environments embedded in racism and sexism." It was a difficult decision for her to make, since there were few Black role models among the faculty. However, she found the workplace toxic, oppressive and racist.

"If academic medical centers and their leaders cannot adequately support Black students and promote Black faculty," Dr. Blackstock wrote, "then they will continue to leave."

We've come a long way since 1837, when James McCune Smith became the first African American doctor. Jim Crow laws have been abolished and schools — in theory, anyway — have been integrated. Recently, we’ve seen a huge wave of support for the Black Lives Matter movement.

Still, only 5 percent of physicians in the United States are Black, despite the fact that the population includes more than double that number of African Americans. That needs to change, but it is important to understand that parity representation in the medical profession alone would be insufficient. To honor the contributions of Black pioneers in medicine, we need to recognize their contributions to science and society, regardless of skin color.

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

Newly Discovered Blood Cells Predict Rheumatoid Arthritis Flareups

By Pat Anson, PNN Editor

A simple blood test could give an early warning to rheumatoid arthritis sufferers that their symptoms are about to get worse, according to a new study published in the New England Journal of Medicine.   

Rheumatoid arthritis (RA) is a chronic autoimmune disease in which the body’s own defenses attack joint tissues, causing pain, inflammation and bone erosion. The symptoms come in waves, with periods of remission interspersed with painful flareups.

Researchers at Rockefeller University have identified a new type of cell – called "PRIME cells" – that dramatically increase in the blood of RA patients a week before a disease flareup.

“If we can reliably identify these new cells in patients, we may be able to tell them ‘You’re about to have a flare,’ so they can prepare themselves,” says lead author Robert Darnell, MD, a neuroscientist at Rockefeller’s Howard Hughes Medical Institute. “This would make flares less disruptive and easier to manage.”

Over a four-year period, researchers analyzed hundreds of blood samples from four RA patients, who collected the blood at home using finger pricks and sent them to Darnell’s lab. Each participant also kept a record of their symptoms to identify when flares occurred.

National Institutes of Allergy and Infectious Diseases

Darnell and his colleagues looked for molecular changes in the blood prior to the onset of symptoms, and saw an increase in immune cells two weeks prior to a flare. That was not surprising, because the cells are known to attack the joints of RA patients.

But in samples collected one week before a flare, researchers saw an increase in cells that didn't match the genetic signature of any known type of blood or immune cell. The RNA signature of the cells resembled that of bone, cartilage or muscle cells – which are not typically found in blood.

“We were so surprised to see that the genes expressed right before a flare are normally active in the bone, muscle, and extracellular matrix -- strange pathways to find in blood cells,” said coauthor Dana Orange, MD, a rheumatologist at Rockefeller. “That really piqued our interest.”

Darnell's team named their discovery PRIME cells because they are "pre-inflammation mesenchymal" cells -- a type of stem cell that can develop into bone or cartilage. Notably, while PRIME cells accumulated in the blood before flares, they disappeared during them.

Researchers say PRIME cells have RNA profiles that are strikingly similar to synovial fibroblasts, which are found in the tissue lining of joints and are known to play a role in causing RA symptoms. In experiments on laboratory mice, fibroblasts that were removed from inflamed joints and transplanted into healthy mice caused them to become arthritic too.

Researchers are now recruiting RA patients for a larger study to confirm whether PRIME cells can predict a flare. If the cells do act as a precursor, it could lead to the development of drugs that target PRIME cells and stop flares before symptoms worsen.

“For doctors and patients, intervention before a flare up is always better than just treating symptoms,” says Darnell. “If these cells are the antecedents to joint sickness, they become a potential target for new drugs.”

The High Cost of California's Death Certificate Project

By Dr. Denise Phan, Guest Columnist

Even as the Covid-19 pandemic occupies the nation’s attention, most of my work as a primary care doctor still revolves around other chronic diseases.  

Every day, people are still giving birth, still getting sick, still dying from terminal diseases, still getting hurt and still having pain. Yet more and more, physicians’ hands are tied when it comes to prescribing opiate medication to reduce their patients’ pain and suffering, especially now that surgeries, physical therapy and injections are discouraged due to social distancing guidelines.

Last year, a patient came to me with a letter from her previous doctor explaining that he is no longer able to prescribe any opiates. The local pain specialists he recommended in his letter were either not taking new patients on opiates or would not prescribe the dosage of oxycodone needed to control her pain.

Several months ago, another patient came in complaining that his pain specialist had cut his dosage down so quickly that he now resorts to street heroin to control the pain and withdrawal.

Yet another patient asked me a few months ago to stop the chemotherapy for his lung cancer and put him in hospice care so he can get adequate pain control.

And just last month, a patient told me she can no longer bear to attend her online fibromyalgia support group because five people in the group had killed themselves in the past few years.

Recently, a frustrated nurse in the oncology/orthopedic ward asked me, “What is it with you doctors? Are you all going to let people scream themselves to death from pain? "

DR. DENISE PHAN

A cardiologist friend of mine remarked, “Ten years ago you could get sued for not prescribing pain meds to patients, now you can get sued just for writing one."

Project Targets ‘Inappropriate’ Prescribing

One of the causes for this sad state of affairs in California is the state medical board’s “Death Certificate Project.” The board investigated the overdose deaths of 450 patients who may have received “inappropriate” opioid prescriptions and sent warning letters to their physicians. Disciplinary action was taken against dozens of them.

The Death Certificate Project sounds like a well-meaning idea, but in practice it has decimated the field of pain management and brought tremendous suffering to patients living with real legitimate pain.

The most egregious of the project's many faults is the decision to pull death certificates from 2012-2013, and then use the state’s prescription drug database to identify "overprescribers." The deaths occurred years before the medical board adopted tougher guidelines on the prescribing of opiates in 2015 and the CDC released its opioid guideline in 2016. 

By this irrational act, the project targeted hundreds of primary care doctors and pain management specialists who were caring for the high-risk populations of chronic pain patients, and were following previous California guidelines to treat pain aggressively and with opiate medications if necessary.  

To date, the board has filed accusations of negligent prescribing against 66 physicians. Forty-eight of them have faced discipline such as license surrender, public reprimands and probation. Some were forced into early retirement. Eighteen doctors are still awaiting hearings or trials. The vast majority of them are responsible physicians who have had no other complaints lodged against them. 

Throughout the Covid-19 pandemic, standards of care and public policies have been rapidly evolving, even flip-flopping from week to week, some causing and some preventing thousands of deaths along the way. It is incredibly irrational to retroactively penalize doctors for following the previous standards of care during a epidemic. Yet this is precisely what the Death Certificate Project is doing by focusing on overdoses in 2012-2013, when the opioid epidemic had not even been recognized or publicized by the medical board itself. 

Imagine going to work every day on the frontline of an epidemic, knowing that the state or federal government can change their policies at any time; and that they can go back and prosecute you for the deaths that resulted from their previous policies.  As we watched our colleagues in the field falling like dominoes one by one, can you blame the doctors for running scared?

The primary result of the Death Certificate Project has been the effective removal of dozens of frontline doctors amid a decades-long shortage of primary care physicians and on the eve of a pandemic. The secondary result of this program is the refusal of terrorized remaining physicians to prescribe any pain medications at all or to drastically reduced the dosages. This has caused a marked increase in pain, suffering and suicide rates in the legitimate pain and addiction patient populations, as well as the subsequent rise in the use of street opioids and thus opioid deaths overall.

The data on California and national overdose deaths shows that prescription opioid overdoses have declined since 2014. Overall drug deaths spiked up sharply in 2017-2018 – but this was mainly due to street heroin and illicit fentanyl. This shows how sadly unnecessary and harmful the project is.

Beside the human and societal costs listed above, this project is costing California millions of dollars annually in funding for administrative, consulting and legal fees. This is not counting the immeasurable cost to the medical system from the loss of physician resources during the biggest pandemic of our time. 

When a medication or treatment does not work as intended and causes many harmful side effects, we need to stop it. If you are a resident of California, please join me in a letter writing campaign to end this irrational, unnecessary, harmful and costly Death Certificate Project at the Action Network website

Dr. Denise Phan is an Internal Medicine physician in Los Angeles. She works in private practice in the San Fernando Valley and is on staff at Valley Presbyterian Hospital. Dr. Phan is active in the annual missions of the mobile health units of the Social Assistance Program for Vietnam and the International Humanitarian Mission. 

Gabapentinoids Involved in a Third of Overdoses in Scotland

By Pat Anson, PNN Editor

A new study in Scotland is shining more light on the risks of overprescribing gabapentin (Neurontin) and pregabalin (Lyrica). The two drugs belong to a class of nerve medication called gabapentinoids, which are increasingly prescribed in Western nations to treat chronic pain.

In 2018, there were 1,187 accidental drug-related deaths (DRDs) in Scotland – the highest overdose rate in the European Union — and gabapentinoids were involved in about a third of them.

According to research published in the British Journal of Anaesthesia, gabapentin was implicated in 15.2% of fatal overdoses in Scotland, while pregabalin was linked to 16.5% of drug deaths. That’s up from 3% and 1% of fatal overdoses, respectively, in 2012.

Researchers say deaths involving gabapentinoids are rising because they are frequently co-prescribed with opioids and other medications that depress the central nervous system and raise the risk of overdose. Drug diversion also plays a role.

“Gabapentinoid prescribing has increased dramatically since 2006, as have dangerous co-prescribing and death. Older people, women, and those living in deprived areas were particularly likely to receive prescriptions. Their contribution to DRDs may be more related to illegal use with diversion of prescribed medication,” wrote lead author Nicola Torrance, PhD, Senior Research Fellow at the School of Nursing & Midwifery, Robert Gordon University, in Aberdeen, Scotland.

From 2006 to 2016, the number of pregabalin prescriptions in Scotland rose by an astounding 1,600 percent, while prescriptions for gabapentin quadrupled. About 60% of the time, gabapentin was co-prescribed with an opioid, benzodiazepines or both.  

Gabapentinoids are also showing up in Scotland’s illicit drug supply. Drug users have found they can heighten the effects of heroin, marijuana, cocaine and other substances. In the Scottish region of Tayside, gabapentinoids were involved in 39% of drug deaths. About three out of four of those overdose victims did not have a prescription for the drug.

In addition to overdoses, gabapentinoids have also been associated with increased risk of suicidal behavior, accidental injuries, traffic accidents and violent crime. UK health officials were so alarmed by misuse of the drugs and the rising number of deaths that gabapentin and pregabalin were reclassified as controlled substances in 2019.

Gabapentin is not currently scheduled as a federally controlled substance in the United States, but pregabalin is classified as a Schedule V controlled substance, meaning it has low potential for addiction and abuse.  

A 2019 clinical review found little evidence that gabapentinoids should be used off-label to treat pain and that prescribing guidelines often exaggerate their effectiveness. The U.S. Food and Drug Administration also recently warned that serious breathing problems can occur in patients who take gabapentin or pregabalin with opioids or other drugs that depress the central nervous system.

You Can Socialize During the Pandemic — Just Do It Carefully

By Bernard J. Wolfson, Kaiser Health News

Cooped up too long, yearning for a day at the beach or a night on the town — and enticed by the easing of restrictions just as the warm weather arrived — many people have bolted from the confines of home. And who can blame them?

But Houston — and San Antonio and Phoenix and Miami and Los Angeles — we have a problem.

COVID-19 is spiking in Texas, Arizona, Florida, California and other states, forcing officials once again to shut down bars, gyms and the indoor-dining sections of restaurants.

But that does not mean we can’t spend time with the important people in our lives. Our mental health is too important to avoid them.

You can expand your social bubble beyond the household — if you heed now-familiar health guidelines and even take extra precautions: Limit the number of people you see at one time, and wear a mask if meeting indoors is the only feasible option or if you can’t stay at least 6 feet from one another outdoors. Disinfect chairs and tables, and wash your hands, before and after the visit. If food and drink are on the agenda, it’s best for all involved to bring their own, since sharing can raise the risk of infection.

Arthur Reingold, a professor of epidemiology at the University of California-Berkeley’s School of Public Health, and his wife, an epidemiologist for the Centers for Disease Control and Prevention, have begun spending time with another couple around their age who have a large patio.

“They have us go around the back; they don’t have us go through the house,” says Reingold, 71. “We sit on chairs that are a good 10 to 12 feet away from each other, and we talk. We bring our food, and they bring their food.”

And they don’t wear masks. “I personally believe the risk from that situation, even without a mask, is pretty minimal,” Reingold says. “But if people wanted to try to do that and wear a mask, I don’t think that would be unreasonable.”

And while we are on the topic of masks, please remember they don’t make you impervious to infection. “Your eyes are part of the respiratory tree. You can get infected through them very easily,” says George Rutherford, a professor of epidemiology at UC-San Francisco. If you are medically vulnerable, or just want to be extra careful, consider wearing a face shield or goggles.

Avoid Big Gatherings

Most of us have wrestled with the question of how big a gathering is too big. It’s impossible to give an exact answer, but the smaller the better. And keep in mind there is no such thing as zero risk.

In the U.S. as a whole, the average infection rate is currently about 1% to 2%, which means one or two people in a group of 100 would typically be infected, says Dr. Yvonne Maldonado, a pediatrician specializing in infectious diseases at Stanford University’s School of Medicine.

In any individual setting, however, these percentages don’t necessarily apply, she says. And a gathering in an area where the COVID-19 rate is surging — or already high — is more dangerous than one of the same size in a place where it’s not. So stay informed about the status of the pandemic in your area.

Be wary even of friends you’ve known and loved a long time. That may sound callous, but you need to know something about the behavior and recent whereabouts of anyone with whom you plan to visit. Don’t be shy about asking where and with whom they have been in recent weeks. If they are a close enough friend for you to want to see them, they should understand why you are asking.

A chart from the Texas Medical Association that generated controversy on Twitter in recent days listed numerous activities, ranked from lowest to highest risk. Among the riskiest behaviors: going to a bar, a movie theater or any other crowded venue — and eating at a buffet. You could ask questions based on that list, or a similar one, to determine if it’s safe to visit with someone.

With regard to play dates for your children, public health experts say you should apply the same safety precautions as for adult get-togethers. “Children can play together, especially if their families have been socially distancing, the activities do not involve physical contact, and they can engage in the activities with sufficient physical spacing,” says Stanford’s Maldonado.

Another question, never far from my mind, is whether it’s risky to let a plumber or electrician or handyman into the house. I’ve put off needed house repairs for several months because of my uncertainty about it.

I put the question to the public health experts I interviewed for this column, and they agreed: As long as you both wear masks and stay a healthy distance apart, the visit should not pose a significant threat. But ask the person what precautions he took on visits to other homes. If he works for a company, check its policies for employees who go from home to home.

Craving Contact

Because I have two large dogs, I have also wondered whether they could be potential virus spreaders — not through their respiratory droplets, but because the virus might land on their fur. When I’m out walking them in the evening and see neighbors with their canines, we usually keep our distance, but once in a while somebody wants to pet one of my dogs, and I’ve been tempted to pet theirs — but have resisted.

My experts say I shouldn’t worry. It is theoretically possible to catch the virus off a dog if somebody just sneezed on it, but that’s an unlikely scenario. The dog’s owner poses a bigger risk.

For those of us who have craved more human contact, it may come as a welcome surprise that some public health experts think it can be safe to hug people (though not dog owners you don’t know) if you follow certain guidelines: Do it outdoors; wear a mask; point your faces in opposite directions; avoid contact between your face and the other person’s body; keep it brief and wash your hands afterward.

Shannon Albers, a 35-year-old resident of Sacramento, says she started hugging people again after reading a story about how to do it safely in The New York Times.

“After 89 days I finally got to hug my mom, and she started crying,” Albers recalls. “We were standing on the driveway, and I said, ‘Do you want a hug?’ She immediately tightened her mask and started coming down the driveway, and I said, ‘Wait, Mom. There’s rules.’”

Chronically ill and elderly people may not want to risk it, says UC-Berkeley’s Reingold. “But if you are out drinking beers with somebody in a crowded room, I’m not sure the hug makes a difference, frankly.”

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

New Imaging Better Identifies Sources of Chronic Pain

By Pat Anson, PNN Editor

A new approach to diagnostic imaging that combines the use of positron emission tomography (PET) and magnetic resonance imaging (MRI) could help identify the causes of chronic pain better than current methods, according to a new study at Stanford University School of Medicine.

PET scans that identify increased glucose metabolism in the body – known as 18F-FDG PET -- are currently used by oncologists to detect where tumors are located. Stanford researchers say the same approach could also be used to more precisely locate inflammation in injured nerves and muscles.

"In the past few decades, we have confirmed that anatomic-based imaging approaches, such as conventional MRI, are unhelpful in identifying chronic pain generators," said Sandip Biswal, MD, an associate professor of radiology at Stanford University School of Medicine.

"We know that 18F-FDG PET has the ability to accurately evaluate increased glucose metabolism that arises from to acute or chronic pain generators. As such, in our study we examined PET/MRI as a potential solution to determine the exact molecular underpinnings of one's pain."

In the study, 65 chronic pain patients underwent 18F-FDG PET and MRI scans from head to toe. The PET/MR images were then evaluated by two radiologists to determine if more glucose uptake occurred in painful areas or in other parts of the body. Increased glucose metabolism was detected in 58 of the 65 patients.

One such patient was an adult male who lived with decades of chronic pain in his neck as a result of an injury experienced at birth. PET/MR scans — such as the image on the right — identified muscles in his right neck near a spinal nerve where there was elevated glucose uptake.

This finding encouraged a surgeon to explore the area. The surgeon found a collection of small arteries wrapped around the nerve. When the arteries were ablated (removed) by the surgeon, it relieved pressure on the nerve and the patient reported tremendous relief.

Cipriano, et al., Stanford University

As a result of PET/MR imaging, 40 patients in the study had their pain management plans modified, including some who had procedures that their doctor had not anticipated, such as surgery to relieve foot pain and the placement of blood patches to treat cerebrospinal fluid leaks.

"The results of this study show that better outcomes are possible for those suffering from chronic pain," said Biswal. "This clinical molecular imaging approach is addressing a tremendous unmet clinical need, and I am hopeful that this work will lay the groundwork for the birth of a new subspecialty in nuclear medicine and radiology.”

Biswal recently presented his findings at the annual meeting of the Society of Nuclear Medicine and Molecular Imaging. They’ve also been published in the Journal of Nuclear Medicine.

New Podcast Discusses Pain and Politics

By Dr. Lynn Webster, PNN Columnist

Not long ago, I was invited to support the Center For Effective Regulatory Policy & Safe Access (CERPSA). The nonprofit was recently founded by Stephen Ziegler, PhD.

CERPSA’s goal is to reduce the suffering that pain patients experience when their access to prescription medication is limited. I felt excited to join CERPSA’s Board of Directors and be a part of the activities the Center would undertake in pursuit of improving the lives of people with pain, including its “Pain Politics” podcast.  

There is probably no topic that has been more politicized and affects more people than pain. Producer and commentator Dr. Ziegler is a man with a mission. Each podcast episode tells stories about how politics informs -- or interferes with -- pain relief.

Dr. Ziegler defines politics as “who gets what, when and how.” Politics are often associated with government actors, but the term can more broadly include how a pharmacy chain implements policies on filling prescriptions, or how an insurance company imposes dose limits of medication for a patient following surgery.

Dr. Ziegler is an advocate for people in pain. A Purdue University professor emeritus, he has also worked as a lawyer, police officer, detective, DEA agent, and humorist. I don't know how he puts these experiences together, but I'm grateful that he is willing and able to leverage all of his skills and knowledge in a remarkable way to produce entertaining and informative podcasts.

There is a large potential audience for the podcast, because pain cuts across all demographics and does not discriminate. The general public will find the podcasts enlightening and timely. The politically charged topics Dr. Ziegler discusses with his guests relate either directly or indirectly to people in pain.

An example of someone who may be interested in Pain Politics would be a stay-at-home mom who suffers from chronic, long-term pain stemming from an automobile accident. She may feel isolated and be struggling with insurance companies and healthcare providers in an effort to find relief.

A veteran who faces stigma for the pain medication he needs to treat injuries received during a tour of duty would be another example, as would an out-of-work school bus driver whose health insurance has disappeared due to the pandemic.

The first Pain Politics episode -- Time for People in Pain to Make Noise -- is an overview of the podcast’s purpose, and how politics play an enormous role in shaping pain treatment, drug policy and human suffering.

In the second episode, Dr. Ziegler tells the Centers for Disease Control and Prevention to "get its head out of its app." This is a theme that will resonate with people who have been struggling with the CDC’s 2016 opioid guideline. Dr. Ziegler pulls no punches as he describes how the CDC has designed a data system that excludes the diagnosis of pain. He believes this, along with other frustrating CDC policies, was politically inspired.

Future episodes of Pain Politics will involve inequality and racism in pain, economics in medicine and pain, universal healthcare, how the DEA and other law enforcement agencies may overstep their roles in prosecuting doctors, the CDC's loss of ethical guardrails, national pain meetings that are politically-driven and not helpful to patients, and the American Medical Association’s recent letter to the CDC asking the agency to rewrite the opioid guideline. Dr. Ziegler will invite guests to appear on his podcasts as he covers these and other areas.

I hope you'll tune in via Apple Podcasts, Google Podcasts, or your favorite way to listen. You'll enjoy Dr. Ziegler's style, and benefit from the information he and his guests provide. I’m pleased to support his efforts.

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