The Pros and Cons of Telehealth

By Barby Ingle, PNN Columnist

The coronavirus lockdown has many providers now offering telehealth or telemedicine – ways to connect with a doctor without actually seeing them in person. Telemonitoring and concierge medicine are also becoming more popular.

The tele-words are often used interchangeably, but they have different meanings. How do you use them? What are the pros and cons?

Telehealth is the distribution of health-related services and information, usually over the phone or online. It allows long-distance patient and clinician contact, care, advice, reminders, education, intervention, monitoring and remote admissions.

Telemedicine is the practice of medicine using technology to deliver care at a distance. A physician in one location uses telecommunication to deliver care to a patient at a distant site.

Telemonitoring refers to the transmission of health data, such as heart rate, blood pressure, oxygen saturation, and weight directly to providers by phone, online or some other electronic means.

Concierge medicine is a relationship between a patient and a primary care physician in which the patient pays an annual fee or retainer. Be sure to check with your insurance to see if they cover concierge medicine or it can be pricey.

Ken (my husband and caretaker) and I have been using telehealth and concierge medicine for more than 5 years. We didn’t choose concierge medicine, but when our primary doctor decided to go that route, we looked into it heavily and made a decision to stay with him.

Our doctor joined MDVIP, a national network of primary care physicians who treat fewer patients and focus on personalized medicine. We can visit him in his office or by phone, text, email and video calls. He offers a wide range of preventive care that is covered in his fees.  And because he works in a network with other providers around the country, if we are traveling and have an emergency, we can see another doctor and it is covered.

Studies published in peer-reviewed medical journals show patients in concierge medical practices receive more preventive services and enjoy better control of chronic conditions than patients in traditional practices. Other studies show concierge patients are hospitalized and readmitted less often, and visit urgent care and emergency rooms less often.

I love having a true partner on my health team.  When you can’t leave home, you can still get that one-on-one service with a provider.  Transportation issues, taking time off from work, and finding child care are no longer an issue for routine visits and follow-up care. Yet, we still have the option for in-person visits when lab tests and other diagnostic tools are needed.

Providers who use telehealth can benefit from the streamlined reimbursements, improved patient satisfaction and retention, reduced no shows and cancellations, and boost the efficiency of their staff and themselves. Providers who use telehealth are also exposed to less virus and bacterial spreading — so its an important safety measure for them, as well as patients.

There can be a few drawbacks to telehealth. If you are not a “tech person,” your first few video calls can be an issue. A recent visit I had with a doctor by video was harder for him than me since I was only his second video appointment ever. For telehealth to work, the patient and provider need to have good internet connections, and some remote places in the U.S. still don’t have that.

If you are using telemedicine services that are not always with the same care team, you could also get a reduction in care quality. What might stand out to your longtime doctor or nurse may not be significant to a provider who doesn’t know your medical history. There is also a lack of personal touch.

Telemedicine is more for cases that don’t require a physical exam.  Telemonitoring is beneficial for chronic patients and the elderly. Concierge medicine is a great combination of telemonitoring, telemedicine and keeping the relationship strong between the patient and provider.

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.  

PROP Linked to New Federal Opioid Study

By Pat Anson, PNN Editor

A small but influential group of anti-opioid activists continues to play an outsized role in guiding federal policy on the use of opioid pain medication.

The latest example is a new report by the Agency for Healthcare Research and Quality (AHRQ) on the effectiveness of opioids in treating chronic pain. In a lengthy review of over 150 clinical studies, AHRQ researchers 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, especially at high doses.

The findings are essentially the same as those in a draft report released by the AHRQ last year. What’s different is that the agency finally disclosed the authors of the report and the outside advisors they consulted with. They include a cabal of academic researchers and physicians with biased views about opioids that federal agencies keep bringing in as consultants.   

The AHRQ’s report confirms what PNN reported in November. The study was led by Dr. Roger Chou, a primary care physician who heads the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University.

Most public health researchers keep a low profile to avoid accusations of bias, but Chou has been a vocal critic of opioid prescribing for years. In a 2019 podcast, for example, Chou said the benefits of opioids were “clinically insignificant” and the medications were often quite harmful.

“The impact of prescription opioids in terms of mortality and substance use disorder and all the other things that come along with it have really been quite staggering,” he said.

Chou also served on a state task force last year that supported a rigid opioid tapering policy. If adopted, the policy would have forced thousands of Oregon’s Medicaid patients off opioids.

DR. ROGER CHOU

“I don’t think there’s anything compassionate about leaving people on drugs that could potentially harm them,” Chou said.

Collaboration with PROP

Chou has collaborated on several occasions with members of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group that seeks to reduce the use of opioid medication. PROP has never disclosed its donors or funding.

Last year Chou co-authored an op/ed with PROP President Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to consider tapering “every patient receiving long term opioid therapy.”

In 2011, Chou co-authored another op/ed with PROP founder Dr. Andrew Kolodny and PROP vice-president Dr. Michael Von Korff. 

The article was prescient because it called for a major overhaul of opioid guidelines that were then primarily developed by pain management specialist organizations.

“Guidelines for long-term opioid therapy should not be developed by the field of pain medicine alone.”

— Kolodny, Chou, et al 2011

“Guidelines for long-term opioid therapy should not be developed by the field of pain medicine alone. Rather, experts from general medicine, addiction medicine, and pain medicine should jointly reconsider how to increase the margin of safety,” they said.

That major overhaul came in 2016, when the Centers for Disease Control and Prevention released its controversial opioid guideline, which soon displaced all of the other guidelines. Chou was one of the co-authors of the CDC guideline – so it’s not altogether surprising that the AHRQ study reaffirms many of the CDC’s conclusions.

“Findings support the recommendation in the 2016 CDC guideline that opioids are not first-line therapy and to preferentially use nonopioid alternatives,” Chou and his colleagues wrote.

In preparing the AHRQ study, researchers sought input from a dozen outside experts, who served as technical experts and peer reviewers. Three of the 12 are PROP board members: Drs. Mark Sullivan and David Tauben were technical experts, and PROP vice-president Dr. Gary Franklin was a peer reviewer. Sullivan, Tauben and Franklin are all professors at the University of Washington, and played prominent roles in the development of Washington state’s opioid prescribing regulations, which are some of the toughest in the nation.

Another peer reviewer was Dr. Erin Krebs, an associate professor at the University of Minnesota Medical School. Krebs was the lead author of a controversial 2018 study that found non-opioid pain relievers worked better than opioids in treating osteoarthritis pain. While some critics said the study was poorly designed and amounted to junk science, it drew praise from Chou.

"The fact that opioids did worse is really pretty astounding," Chou told the Chicago Tribune. "It calls into question our beliefs about the benefits of opioids." 

In addition to her work as a researcher, Krebs also appeared in a lecture series on opioid prescribing funded by the Steve Rummler Hope Foundation, which lobbies against the use of opioids. The non-profit foundation is the fiscal sponsor of PROP, and Kolodny and Ballantyne both serve on its medical advisory committee.

If these intertwining connections are making your head spin, there’s more.

Core Expert Group

Ballantyne, Franklin and Krebs served on the “Core Expert Group” that advised the CDC when it drafted its opioid guideline, and Tauben was on the CDC’s peer review panel. Kolodny and yet another PROP board member, Dr. David Juurlink, were part of a “Stakeholder Review Group” that provided input to the CDC.

When PNN filed a request under the Freedom of Information Act (FOIA) to see what kind of advice the Core Expert Group gave to the CDC, we were stiff-armed by the agency. The CDC sent us nearly 1,500 pages of documents, but most were so heavily redacted they were completely blank.    

Even financial conflict of interest statements were scrubbed of information, with the CDC citing “personal privacy” and “deliberative process privilege” as reasons not to provide them in full.

At least two unidentified members of the Core Expert Group worked for or consulted with organizations with an interest in opioids or other controlled substances. One of those individuals also provided “expert opinion or testimony,” which has become a lucrative sideline for some PROP members.

Critics wonder why federal health agencies keep bringing in consultants with obvious biases and conflicts of interest.

“The AHRQ review presents itself as an objective scientific analysis of the medical literature. In my opinion, the document is arguably contaminated with a political agenda,” says Dr. Dan Laird, a physician attorney in Las Vegas. “Some of those involved in the review could be perceived by the chronic pain community as having strong anti-opioid political views and biased ideas about the meaning and treatment of chronic pain.

“Most importantly, there is no input whatsoever from the chronic pain community in the review. There are certainly chronic pain patients with academic credentials that would qualify them to conduct a literature review. Several highly regarded academic physicians and scientists, known for opioid moderatism, are conspicuously absent as investigators, peer reviewers, or technical experts; these include pain medicine academicians such as Drs. Michael Schatman, Sean Mackey, Stefan Kertesz, and Vanila Singh.”

AHRQ Conflict Policy

If a peer reviewer or technical expert has a financial or professional conflict of interest, that does not automatically disqualify them in the eyes of the AHRQ, which will retain them “because of their unique clinical or content expertise.”  

It’s also been a long-standing AHRQ policy not to disclose the names of advisors or authors until its reports are finalized.

“This policy is aimed at helping the authors maintain their independence by not being subject to lobbying by industry reps or others with conflicts of interest, either financial or intellectual,” AHRQ spokesman Bruce Seeman explained in an email.

But others wonder if the policy damages the agency’s reputation and the credibility of its research, by not giving the public a chance to review and comment on possible biases before a final report is released. The American Medical Association urged the AHRQ to change its policy last year.

“We would suggest that AHRQ publish the list of all those involved in any aspect of the report during the comment period to help remove any perception of potential conflict,” Dr. James Madara, the AMA’s Executive Director and CEO, wrote in a letter to the agency last year.

CDC Guideline Update

It might be tempting to dismiss the work of an obscure federal agency that produces wonky reports that are mostly read by public health researchers and government bureaucrats. That would be a mistake. It was a 2014 AHRQ report on opioids – co-authored by Chou – that played a foundational role in the CDC guideline.

Although the CDC guideline is voluntary and only intended for primary care physicians treating chronic pain, it has become mandatory policy for doctors in all specialties, as well as other federal agencies, dozens of states, insurers, pharmacy chains and law enforcement agencies. In effect, the guideline has delivered on the goals sought by Kolodny, Von Korff and Chou in 2011. The standard of care in pain management is no longer determined by pain specialists.

Chou and his colleagues hope the new AHRQ report will have a similar impact, not just in government, but throughout the healthcare system.

“The information in this report is intended to help healthcare decision makers — patients and clinicians, health system leaders, and policymakers, among others — make well-informed decisions and thereby improve the quality of healthcare services,” they said.

In addition to its report on opioid treatments for chronic pain, AHRQ has also finalized studies on the effectiveness of Nonopioid Medications for Chronic Pain and Nonpharmacologic Treatments for Chronic Pain, such as acupuncture and meditation.

All three reports will be utilized by the CDC as it prepares an update and expansion of its opioid guideline, which is expected in late 2021.  That effort is being overseen by the Board of Scientific Counselors at the CDC’s Center for Injury Prevention & Control.  Roger Chou happens to be one of its members.  

CDC Seeking Comment from Pain ‘Stakeholders’

By Roger Chriss, PNN Columnist

The Centers for Disease Control and Prevention has made an unusual request for public comment about the use of opioids and the management of acute and chronic pain.

In a notice published last week in the Federal Register, the CDC said it wants to “obtain comment concerning perspectives on and experiences with pain and pain management, including but not limited to the benefits and harms of opioid use.”

Comments are being sought from patients with chronic or acute short-term pain, their family members, caretakers and healthcare providers – what the agency bureaucratically calls “stakeholders.”

“Public comment will help CDC's understanding of stakeholders' values and preferences regarding pain management and will complement CDC's ongoing work assessing the need for updating or expanding the CDC Guideline for Prescribing Opioids for Chronic Pain,” the agency said.

To leave a comment in the Federal Register, click here.

The CDC doesn’t always seek comments from the public. The agency’s 2016 opioid guideline was initially drawn up without any public hearings or input from patients. It was only after a public outcry that hearings were held and comments were sought in the Federal Register. Over 4,000 people responded, most of them opposing the guideline.

Since then, the federal government has continued to get an earful from patients, providers, medical organizations and various panels about how harmful the guideline has been for pain sufferers and why a “one-size-fits-all approach” to pain management doesn’t work.

For instance, in May 2019, the Pain Management Best Practices Inter-Agency Task Force issued a long-awaited report on pain management, emphasizing the “importance of individualized patient-centered care in the diagnosis and treatment of acute and chronic pain.”

In December 2019, the National Academies of Sciences, Engineering, and Medicine issued another report outlining “a framework for prescribers and others to develop their own plans for acute pain.”

At present, the National Institute of Health’s HEAL Initiative is developing web services for chronic pain management, along with working on research to predict pain.

Moreover, physicians like Dr. Stefan Kertesz have written about the need for nuance in pain management. And pain psychologist Dr. Beth Darnall has written about the need for patient-centeredness in chronic pain, while also working on clinical best practices at the Patient-Centered Outcomes Research Institute.  

Patients themselves have drawn attention to the problem, from TED talks by advocates like Kate Nicholson to nationwide rallies by the group Don’t Punish Pain.

Nearly one year ago, the CDC finally recognized that the opioid guideline was being widely misapplied and issued a long-overdue “clarification” urging policymakers to stop treating its voluntary recommendations as law.

The American Medical Association said it was about time.

“The guidelines have been treated as hard and fast rules, leaving physicians unable to offer the best care for their patients,” said AMA President Patrice Harris, MD. “The CDC’s clarification underscores that patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than the guidelines or thresholds put forward by federal agencies, state governments, health insurance companies, pharmacy chains, pharmacy benefit managers and other advisory or regulatory bodies.”

Patients and providers have been sharing their perspective and experiences for years, with little evidence to suggest that the CDC has been paying much attention. Not a word of the guideline has changed, although the agency is working on an “update” that may be done in late 2021.

As the number of pain stakeholders continues to rise and their care is complicated by COVID-19, the CDC needs to look seriously at the many years’ worth of clearly expressed “values and preferences.” If the CDC needs even more information, so be it. But it’s hard to figure out how much more clearly all the stakeholders can speak.

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.

Why Can’t We Find a Cure for COVID-19 More Quickly?

By Dr. Lynn Webster, PNN Columnist

Americans love to hate Big Pharma, its greed and self-interest is evident. Nearly doubling the price of insulin makes it unaffordable for many, and the 5,000% price increase for the infection-fighting drug Daraprim are just two examples of avarice that have fueled the loathing of the pharmaceutical industry.

However, if we are going to find a cure for COVID-19, it will come from Pharma. These days, we hear fewer complaints about greed and more inquiries about speed. Why can’t we find a cure for COVID-19 more quickly?

Understanding the process of drug development may not change anyone’s attitude towards Pharma, but it can help us understand why we’ll be waiting awhile for COVID-19 treatments and vaccines.

Phases of Drug Development

Drug development begins with trying to find a substance that has the potential to treat or prevent a disease. This is called the discovery process. Once a drug candidate is chosen, it must be studied in animals to determine its potential risk to humans. If the risks appear acceptable, human clinical trials can begin.

When a candidate therapy is ready for a Phase I human trial, it must be approved by the U.S. Food and Drug Administration. Initial doses given to volunteers are very low. Then they are gradually and methodically increased until side effects develop. This allows researchers to determine a reasonably safe potential therapeutic dose.

Phase I trials for COVID-19 drugs and vaccines are frequently discussed in the news as if these tests can determine their effectiveness. However, Phase I studies only evaluate safety. They don't reveal how well the drug will work.

If a drug appears to be reasonably safe on the basis of a Phase I study, it moves to Phase II. This is the first time a drug is given to see if it has a signal for efficacy. Unfortunately, most drugs fail to demonstrate safety in Phase I and in Phase II trials.

The few drugs that survive Phases I and II advance to Phase III. Most Phase III trials involve testing approximately 1,000 subjects, and usually take 1 to 2 years to complete.

How many drug candidates survive this long process? Only about 14 percent of drugs that enter Phase I clinical trials are ultimately approved by the FDA.

Fast-Tracking Drugs to Beat the Pandemic

If drugs successfully pass all three test phases, the results of the studies are submitted to the FDA for approval.

On February 29, the FDA established an accelerated process for potential COVID-19 therapies and vaccines. In addition, drugs can also be accepted for study via the FDA's "Fast Track" path.

The graphic below shows the average length of time it takes to conduct the normal phases of drug development (up to 15 years) compared to the Fast Track process (up to 5.5 years). The new accelerated path for COVID-19 therapies should be much shorter.

The graphic also shows how many research studies for COVID-19 treatments were in each stage of development as of April 11, 2020.  

The National Institutes of Health (through clinicaltrials.gov) reports there are 156 COVID-19 treatments in the pipeline, some of which could take up to 5.5 years to produce a viable treatment. That doesn’t sound very helpful for today’s crisis.

However, some already-approved drugs can be studied for new applications. This usually occurs in Phase IV studies. Hydroxychloroquine, remdesivir, and tocilizumab are three examples of drugs approved for other uses that are currently being studied as possible treatments for COVID-19. Results from studies using already approved drugs can be available within a few months.

But we need to know that, when these drugs are repurposed, they are safe for the new use. That is not always the case. For example, Brazil ended a recent chloroquine study because the drug seemed to be causing coronavirus patients to have irregular heartbeats.

Currently, there is no cure or vaccine proven to be effective against COVID-19. There simply hasn't been enough time to conduct the required research. However, there is a gallant worldwide effort to find effective treatments and vaccines.

Now is the time for Pharma to use its extraordinary expertise to provide the world with effective treatments for this pandemic. Although antipathy toward Pharma may remain, this is the time to cheer for their success. Our lives may depend on it. 

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.

What Is CDC Trying to Hide?

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention made little attempt at openness and transparency when it released a draft version of its controversial opioid guideline in September 2015.

No public hearings were held. Only a select audience was invited to a secretive online webinar in which CDC officials hurriedly outlined the guideline and then refused to answer any questions about it. The guideline wasn’t posted on the CDC website and no copies were made available.

Even more puzzling is that the CDC refused to disclose who wrote the guideline or served on advisory panels such as the so-called “Core Expert Group” that played a key role in drafting the recommendations. Their names leaked out anyway.

What was the agency trying to hide?

Those issues were important five years ago, just as they are today.  While the opioid guideline was only intended as a recommendation for primary care physicians treating chronic pain, it has effectively become the law of the land for all doctors in every specialty – and adopted as policy by states, insurers, pharmacy chains and law enforcement agencies.

As a result, in the name of preventing addiction, millions of pain patients have been cut off from opioids and gone without adequate pain treatment, with an untold number of suffering souls committing suicide.

Only when threatened with a lawsuit and a congressional investigation of the guideline process did the CDC back down, delaying the release of the guideline for a few months. Hearings were held, public comments were accepted, and CDC revealed the names of its experts and outside advisors, including some who had strong biases against opioids.

Five were board members of Physicians for Responsible Opioid Prescribing (PROP), a small but influential advocacy group founded by Dr. Andrew Kolodny, a psychiatrist who was then-medical director of Phoenix House, an addiction treatment chain. PROP President Jane Ballantyne, MD, and Vice-President Gary Franklin, MD, were members of the Core Expert Group, while board member David Tauben, MD, served on the CDC’s peer review panel. PROP member David Juurlink, MD, and Kolodny himself were part of a “Stakeholder Review Group” that provided input to the CDC.

Concerned about the apparent one-sided approach to the guideline, a bipartisan group of congressmen on the House Oversight and Government Reform Committee wrote a letter to then-CDC director Thomas Frieden, a longtime associate of Kolodny.

“We expect CDC’s guidelines drafting process to seek an appropriate balance between the risk of addiction and the need to address chronic pain,” wrote Chairman Jason Chaffetz (R-Utah). “The CDC has utilized a ‘Core Expert Group’ in the drafting and development of opioid prescribing guidelines, raising questions as to whether CDC is complying with FACA (Federal Advisory Committee Act).”

Chaffetz and his colleagues asked Frieden to supply documents and information about the guideline process “as soon as possible.”

‘Some Information Was Withheld’

We were curious about Frieden’s response and filed a Freedom of Information Act (FOIA) request with the CDC last year, asking for “copies of all documents, emails, memos and other communications” that the agency sent in response to Chaffetz’s letter.

The CDC’s reply, received a few weeks ago, is just as puzzling and secretive as the agency’s actions in 2015.  Nearly 1,500 pages of documents provided to PNN were heavily redacted or scrubbed of all information. As a result, over 1,200 pages were completely blank.

“We located 1,449 pages of responsive records and two Excel workbooks (108 pages released in full; 103 pages disclosed in part; 1,238 pages withheld in full). After a careful review of these pages, some information was withheld from release,” Roger Andoh, who heads the CDC’s FOIA Office, wrote in a letter to PNN.

Andoh cited two FOIA exemptions to justify withholding the information. The first exemption protects material under a broad declaration of “deliberative process privilege.” Material that’s in draft form, including a reviewer’s comments and recommendations, can be withheld by the government because they are “predecisional and deliberative.”

The second FOIA exemption cited by Andoh protects information that is private because releasing it would be “a clearly unwarranted invasion of personal privacy.”  

The privacy exemption was applied often to documents from a June 23, 2015 meeting of the Core Expert Group. We can see from the agenda that it was an important meeting, with clinical evidence about opioids reviewed in the morning, followed by a lengthy panel discussion in the afternoon. But we don’t know who said what because the minutes from that meeting have been deleted.

Whenever you see the notations “(b)(5)” or “(b)(6)” appear means that some information was withheld.

SOURCE: cdc foia office

The privacy exemption was also applied to the financial conflict of interest statements filed by all 17 members of the Core Expert Group (CEG). Their names and signatures were redacted, so we have no idea who they were or what conflicts they declared.

One CEG member checked a box indicating they did consulting work for “a commercial entity or other organization with an interest related to controlled substances.” Opioids are a controlled substance and so is Suboxone, an addiction treatment drug. It would be important to know who that person was, but their name was redacted, along with name of the organization they worked for.

The same individual also checked a box indicating they “provided an expert opinion or testimony.” But because the information was redacted, we don’t know if the person was paid for their testimony and, if so, who they were paid by and what the amount was.

Information was also withheld about other CEG members who were given grants, honoraria, and reimbursement for travel and lodging by organizations with an interest in controlled substances. One CEG member was actually employed by such an organization, but we don’t know who that was or who they worked for..

In short, several members of the Core Expert Group had a financial conflict of interest and disclosed it to the CDC, but the agency has decided – five years later -- that information should not be made public.

(Update: In 2022 testimony in West Virginia, Kolodny testified that he started working on opioid litigation in 2012 with Linda Singer, then with the law firm of Cohen Milstein, and that he was eventually paid a million dollars or more for his work as an expert witness and consultant. It’s unknown if Kolodny disclosed that relationship to the CDC.)

‘There Was a Cover-Up Here’

We asked three advocates in the pain community to review the documents CDC provided to PNN. All three were puzzled why so much information was withheld.

“I think what they sent is an embarrassment. There is no reasonable or rational explanation to redact any part of a suggested guideline process especially since the CDC admits the guidelines were misapplied and misinterpreted,” said Julie Killingworth, a disabled activist. “I believe the ridiculously heavy number of redactions is a clear admission of guilt. The CDC has committed at least one or multiple federal crimes and the House Oversight Committee needs to closely revisit their December 18, 2015 letter of concern to Dr. Tom Frieden.”

“There was indeed a cover-up here, grounded primarily on the escape clauses in the FOIA enabling legislation which exempts the government from revealing its internal processes or consultations to the public,” said Richard “Red” Lawhern, PhD, who heads the Alliance for the Treatment of Intractable Pain. “Unfortunately, this broad exception to full public disclosure permits agencies to hide their own biases, failures of transparency, or arbitrary decisions.    

“Masking the identities of individuals who contribute to policy can also make it practically impossible to assess bias, conflict of interest, or outright misrepresentation. The extensive redacting of documents raises concern that the reviewing office has engaged in a broad cover-up by masking the identities and professional or personal affiliations of those who contributed to the CDC Guidelines." 

“It could well be that there would be nothing surprising or unseemly in the redacted information. But if you don't want people to think you are trying to hide something nefarious, then the old saying that sunlight is the best disinfectant certainly would seem to apply here,” said Bob Twillman, PhD, a former executive director of the Academy of Integrative Pain Management, who was also a member of the CDC’s Stakeholder Review Group. 

“It's mystifying and sad to me that CDC will not reveal who was involved in the deliberations that led to the issuance of its opioid prescribing guideline, even though they have publicly revealed much of this information elsewhere.” 

Twillman points out that the identities of the Core Expert Group, as well as other advisors and contributors to the guideline, were all published in a JAMA article and by the CDC itself when the final guideline was released in 2016.  

Redacting their names and conflicts of interest, as well as minutes and notes from their deliberations, is likely to fuel long-standing suspicion in the pain community that the guideline process was tainted by bias and that much of the clinical evidence was cherry-picked.

“What's worse for me is the refusal to help people understand the deliberative process that went into drafting the recommendations in the guideline,” says Twillman. “An interesting issue that is probably covered by the redacted material is the decision to reject any evidence except RCTs (randomized controlled trials) when evaluating benefits of opioids, but to accept weaker types of evidence when evaluating harms of opioids. Why did the group decide this was acceptable, and not insist on a level playing field for evidence regarding these two questions?” 

The CDC recently announced plans to update and expand its opioid guideline, most likely to include the treatment of short-term, acute pain. Whether the agency will use more transparency and openness in that process remains to be seen. The updated guideline is expected in 2021.

A Pained Life: A Tortured Wait

By Carol Levy, PNN Columnist

I just heard a woman on TV talk about her recovery from the coronavirus. “I am feeling absolutely horrid, but at least I know there is an end in sight,” she said.

This came on the heels of an episode of Law and Order I was watching. A woman who was tortured had bandages on all of her fingers.

“This man showed up in my apartment. I don’t know who he was. But he wanted information,” she said. “He burned my fingertips. I would have told him anything to make the pain stop.”

Many years ago, I saw an ophthalmologist. It was after the start of my trigeminal neuralgia. Any touch to the affected area of my face, even a strand of hair or a wisp of a breeze, triggered horrendous pain.

I reminded him, “Please warn me before you touch my face so I can prepare myself for the pain.”

He turned to another doctor and said, “This is how you do torture. You reduce their tolerance so all you have to do is touch them to cause pain.” Then he proceeded to touch my face and set off an explosion of pain.

Pain is horrendous. It is something we are biologically programmed to avoid. But there is no end in sight for those of us with chronic pain. Torture is a fact of life for us.

Tell someone you have pain from a sprained finger, a broken foot or a stiff neck, and rarely will you not get understanding and sympathy. Tell someone you have chronic pain and often the reply is, “Guess you have to learn to live with it.”

It is bad enough in normal times, but right now is anything but normal. Many of us with chronic pain have an added stress to the normal stress of living with pain.

My new brain implant is causing more pain than before the surgery. I cannot see my neurosurgeon. His office canceled two upcoming appointments.

I will probably not be able to see him until June or July at the earliest. The patients who can see him now are those who may have a brain tumor or another serious illness.

Once self-isolation ends, as a person in pain I will be close to the end of the line in terms of when I will be seen. I get it. It makes sense. But it adds to my feelings of aloneness. I have no doctor to help me and fear the pain will get worse. There's nothing I can do.

“Learning to live with it” is even harder when the normal resources are out of reach. The one thing we can count on is what the coronavirus patient said: “There is an end in sight.”

For us, that ending will be when we can see our doctors again and get our medications, therapies and treatments without being turned away.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.”

9 Ways to Stay Healthy During Coronavirus Lockdown

By Pat Anson, PNN Editor

You’re tired of binging on Netflix. You’ve run out of closets to organize. The gym is closed indefinitely. The walls seem to be closing in. Depression and despair -- what Churchill called his “black dog” – are lurking in the shadows.

How is someone supposed to stay physically and mentally healthy during weeks – and probably months – of home isolation?

Whether you’re healthy, disabled or living with chronic illness, maintaining some level of physical fitness is important for overall health and avoiding the depression, anxiety and insomnia that inactivity can bring. It can also help reduce your pain levels.

With no further ado, here are 9 ways to make self-isolation a little easier to bear.

#1 Light Fitness

One basic step you can take is to adopt a “light fitness” routine.     

“If the sky is clear and the sun is shining, go for a walk during the day. Try to go outside in the morning, every day, at the same time, for a period of 30 minutes or so,” says Mariana Figueiro, PhD, a leading expert on the health benefits of light and director of the Lighting Research Center at Rensselaer Polytechnic Institute.

Figueiro believes that maintaining a 24-hour light–dark schedule increases alertness, mood and vitality during the day, while helping people sleep at night. It may even have a protective effect against coronavirus by boosting your immune system.

If you must stay indoors, Figueiro suggests increasing the amount of light by a factor of four (x4) during the day. That means if you have one lamp in your living room, bedroom or wherever you spend the most time during the day, add three more lamps for a total of four.

In the evening, dim those lights. And avoid using a computer, smartphone or TV right before bedtime. The glow from an electronic screen can make it harder for you to fall asleep.

“A robust pattern of light during the day and darkness at night is important for our health and well-being,” Figueiro advises. “Open the window curtains or shades. Seek light during the day, especially during the morning. Go out for a walk during lunchtime. Dim the lights in the evening, mimicking sunset.”

Opening curtains and blinds to let in sunlight may also help kill the coronavirus, according to scientists at the University of California, Davis.

“In a study simulating sunlight on influenza virus aerosols, virus half-life was significantly reduced from 31.6 min in the dark control group to approximately 2.4 min in simulated sunlight,” researchers said.

“Further research is needed to understand the impact of natural light on SARS-CoV-2 indoors; however, in the interim, daylight exists as a free, widely available resource to building occupants with little downside to its use and many documented positive human health benefits.”

#2 Geezer-Fast Yoga

One way to stay in shape during the coronavirus lockdown is to adopt a home exercise routine. 84-year old Denny Hatch began practicing yoga several years ago at the urging of his wife, who saw him struggling just to bend over and put on socks.

Weekly hour-long yoga sessions helped Hatch feel limber and pain-free again. But he thought yoga took too much time.

“Yoga is slow. Slow yoga bores the hell out of me and I wanted something faster. So I cut the practice in half and speeded up the movements,” Hatch says.

For 26 minutes every morning, Hatch goes through a series of low-impact yoga moves in his living room. Hatch recently shot and narrated a free video that he calls “Geezer Fast-Yoga” to help others learn his techniques.

“I decided to share this shortened version in the hopes other senior men might find it useful —especially in this time when so many of us are forced to remain in home detention,” Hatch says. “I invite you to have a look. Maybe you’ll find it helpful.”

Hatch notes that he is not a licensed yoga instructor. If you feel any kind of pain from any of the moves in his routine, he urges you to stop immediately and consult a physician. 

#3 ‘Focus on What’s Healthy’

If you want to get out of the house and exercise, you could take the advice of Becky Curtis: Go for a long hike.

Before you say, “I can barely get off the couch,” listen up.

In 2005, Curtis was partially paralyzed after a car accident nearly killed her. Recovery was slow. Curtis was in so much pain and so isolated that she felt “claustrophobic in my own body.” But she focused on finding positive things to do – like learning how to walk again -- and made realistic goals and behavioral changes to get her mind off the pain.

Three years after her accident, Curtis became a pioneer in pain management counseling by launching Take Courage Coaching. In weekly sessions by phone, Curtis shares with clients the techniques that she learned to manage pain and end her isolation and self-doubt.

“Maybe some of the things that I’ve learned can be helpful to you during this time,” Curtis says. “I focus on what’s healthy, what’s whole, what’s right and what’s good. And in doing that, it helps my pain.”

Curtis is working on a series of free videos to help people get through the stress and fear of COVID-19. In her first video, she’ll take you on a two-mile hike through the mountains near her home in Sandy, Utah.

#4 Laugh at Jack Black’s Dance Routine

If exercise is not your thing, laughing is a good alternative. It gets the heart beating and the lungs aired out.

Like the rest of us, comedian and actor Jack Black has been staying home during the coronavirus lockdown. He also found a way to keep us entertained by donning a cowboy hat, cowboy boots and, thankfully, a pair of shorts while performing a “Quarantine Dance” in a short video that’s been seen millions of times on TikTok and Instagram.

#5 Watch Some Good News

Ready for some good news? Aren’t we all?

Actor John Krasinski, who starred in The Office and Tom Clancy’s Jack Ryan, has a new talk show on YouTube in which he shares good news from around the world.

“Without question, we are all going through an incredibly trying time. But through all the anxiety, all the confusion, all the isolation and all the Tiger King, somehow the human spirit still finds a way to breakthrough and blow us all away,” Krasinski says.

Topping the list of good news in Krasinski’s first show is the heroism of healthcare workers, delivery drivers and others who keep the world functioning while the rest of us take a break from it.

#6 Make a Face Mask

Some communities, such as Los Angeles, now require people to wear a face mask or facial covering when they visit a grocery store and other essential businesses that have stayed open.

Don’t have a face mask? U.S. Surgeon General Dr. Jerome Adams demonstrates how you can easily turn an old scarf or t-shirt into a facial covering that you can wear while heading from store to store in search of a real mask. 

#7 Howl at the Moon

To break up the monotony of being at home, some people are going outside in the early evening to chat with neighbors (at a safe distance), bang pots and pans, sing, and cheer on healthcare workers.

There’s even a Facebook group dedicated to howling at the moon — every night at 8 pm in whatever time zone you live in. The group has over half a million members!

While some of the howling videos are amusing, don’t expect a lot of laughs. The group has evolved into a memorial and gathering place for people who have lost loved ones or are dealing with a severe illness.

“Lost my dad to the flu and pneumonia on March 19, 2020 and lost my brother to cancer on March 22, 2020. I will be howling for them,” one member posted.

#8 Try a Meditation App

There’s an app for everything, including several that can help you relax, feel happier, fall asleep easier and reduce anxiety. I just downloaded one called Box Breathing that specializes in meditation and guided breathing exercises you can do at home.

“Find a comfortable position. You can either be seated or lying down. Start by feeling your body sinking into the support beneath you,” instructs Lynne Goldberg during a two-minute meditation program for self-care during the coronavirus outbreak.

Box Breathing has free meditations for things like boredom and financial anxiety. There’s also a paid version that gives you access to hundreds of guided meditations, including some that focus on chronic pain, migraines, high blood pressure and healing your body

Calm is a similar app that has a 7-day free trial, followed by a paid subscription.

#9 Take Our Survey

Finally, be sure to take our survey on the coronavirus.

PNN has partnered with the International Pain Foundation and the Chronic Pain Association of Canada to see how the coronavirus pandemic is affecting people with chronic pain and chronic illness — who are most at risk from COVID-19.

The survey only takes a few minutes and will be closed soon. Click here to get started.  

What are you doing to pass the time and stay healthy that might be helpful to other people who are self-isolating? Let us know in the comment section. And stay safe out there.

I’m Lonely. Are You Lonely Too?

By Ann Marie Gaudon, PNN Columnist

We are born for connection and being socially separated is bad for our physical and emotional health. From altering our immune systems to creating more inflammation to increasing the risk of heart disease and stroke, the health consequences of loneliness are significant.

Being a chronic pain patient can put you at even greater risk of being lonely. On the one hand, we know that social isolation is unhealthy, but on the other hand, we don’t have a choice as we must practice social distancing and self-isolation to protect ourselves and others from the coronavirus.

I’m lonely, you’re lonely – now what?

Don’t Do This

Do not attempt to run from your loneliness by zoning out for hours on end with Netflix or video games, consuming too much alcohol or other substances, or over-eating.  Trying to escape loneliness that way might give you some reprieve in the short-term, but those strategies will suck the life out of you in the long-term.

Trying to avoid or suppress feelings actually has a rebound effect in that they become stronger and more invasive in our lives. Avoidance is not a benign strategy and can have catastrophic results.

Do This Instead

Pay attention on purpose. Slow down, notice and name it. For example, “I am feeling lonely. It feels heavy and sluggish in my heart.”

Can you let this feeling be there just as it is, without judging or evaluating it? Without reacting to it? Can you just slow down and let your body feel what it is feeling? Can you let go of the urge to do anything at all with this feeling of loneliness? This is a normal response to an abnormal situation and your body is wise to this, so let it be.

Make an intention. Ask yourself, “What will I do with this feeling of loneliness now? My mind sees this as something that makes me weaker, unlovable and sad. But I choose not to buy into this. I accept that this loneliness is mine. What will I do with it now that it is here?”

The way out of this suffering is to behave your way out of it. Changing your behaviour will change the way people interact with you and will also change the way you interact with yourself. Make an intention to change your behaviour while holding the loneliness lightly, as you might hold a butterfly on your hand.

Expand your experience. You’re not going to shrink away from your experience of loneliness, but rather learn from it. We hurt where we care. Loneliness tells us that we care deeply about relationships. If we didn’t, we wouldn’t feel anything at all.

You will learn that your experience cannot bring you to your knees or ruin your life. You will learn that you can go through hell on earth and still treat yourself in a non-judgmental, non-reactive way. You will learn to wrap yourself in the warmth of self-kindness – even in moments of loneliness – and expand out into life to be part of this world.

Stay Connected

If you are reading this, you already have at least one technology that you will use to move forward with a new meaning. How you take control over what you do have control over – your behaviour – will be up to you, so choose something that you value.

People all over this planet are getting creative with ways to connect with each other. Stay connected to those you love. Use your phone or software such as Skype or Zoom. Use whatever floats your boat, just remain consistently connected.

There’s a virtual world out there for everyone. You can access therapy, support groups, entertainment of all kinds, exercise of all kinds, and even stream from your local library. How about taking that online course right now that you’ve been putting off? The great thing is that you can connect with a resource anywhere in the world.

The take-away message is this: Feel what you feel and make an intention to change your behaviour. Expand your world even if has to be online right now. Talk with people, laugh with people and cry with people.

The point is to emotionally connect during these especially lonely times. Texting, emailing, speaking, video-conferencing – the sky's the limit. Change your behaviour and change your life. Self-isolation need never mean emotional isolation.

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

Experts Say IBD Patients Not at Higher Risk From Coronavirus

By Pat Anson, PNN Editor

Patients with Crohn's disease, ulcerative colitis and other inflammatory bowel diseases (IBD) are not at greater risk from the coronavirus and should continue their regular therapies, according to new guidance by the American Gastroenterological Association (AGA) published in the journal Gastroenterology.

IBD is an immune system disorder that causes abdominal pain, diarrhea and weight loss. Symptoms and progression of the disease can be controlled by medications such as prednisone that suppress the immune system, which has led to concern that patients taking the drugs may be more susceptible to coronavirus infections.

Some IBD patients also need to visit medical facilities for infusions and other procedures, which may increase their risk of exposure to the SARS-CoV-2 virus.

“Despite the potential for increased exposure to SARS-CoV-2, the limited available data and expert opinion suggest that patients with IBD do not appear to have a baseline increased risk of infection with SARS-CoV-2 or development of COVID-19,” wrote lead author David Rubin, MD, Co-Director of the Digestive Diseases Center at University of Chicago Medicine.  

“It is unclear whether inflammation of the bowel per se is a risk for infection with SARS-CoV-2, but it is sensible that patients with IBD should maintain remission in order to reduce the risk of relapse and need for more intense medical therapy or hospitalization.”

Rubin and his co-authors say there is limited information on the severity of coronavirus symptoms in IBD patients, although one study in China found they were “more likely to be hospitalized.” While COVID-19 is primarily a respiratory illness, the virus can cause digestive problems and is detected in stool samples.

The experts recommend that IBD patients who do not have coronavirus symptoms continue their current treatments to avoid relapsing.

“Aside from the obvious negative consequences of a relapse, relapsing IBD will strain available medical resources, may require steroid therapy or necessitate hospitalization, outcomes that are all much worse than the known risks of existing IBD therapies,” Rubin wrote. “Similar to the recommendations to the general population, patients with IBD should practice strict social distancing, work from home, have meticulous hand hygiene, and separate themselves from known infected individuals.”

Infusion centers should have a protocol to pre-screen IBD patients for fever and other coronavirus symptoms, and providers and patients should wear masks and gloves.

For patients who test positive for the coronavirus or develop symptoms, the experts recommend lower doses of prednisone and a temporary halt to biological therapies and immune suppressing drugs such as thiopurines, methotrexate, and tofacitinib.   

“For the patient with COVID-19, adjustment of the medical therapy for IBD is appropriate, based on the understanding of the immune activity of the therapy and whether that therapy may worsen outcomes with COVID-19,” Rubin wrote. “For hospitalized patients with severe COVID-19 and risks of poor outcomes, IBD therapy likely will take a back seat, but choice of therapies for COVID-19 should take into account the co-existing IBD, if feasible.”

Over 3 million people in the United States have IBD. The AGA has developed a flow chart for providers treating IBD during the COVID-19 outbreak and a reference chart for IBD patients.

Now It’s Our Turn

By Dr. Lynn Webster, PNN Columnist

These are hard times. When our emotions are intense and frayed, it’s often helpful to share those feelings.

Pain News Network, in collaboration with the International Pain Foundation and the Chronic Pain Association of Canada, is conducting a survey to see how the coronavirus pandemic is affecting people with chronic pain and chronic illness — who are most at risk from the virus.

They want to hear about your worries, concerns, and how you are trying to find meaning and purpose in a time of crisis. The survey is one way in which you can stay connected with others.

I encourage you to take the survey and share it with as many people as possible. Click here for the link.

The survey findings will be sent to those who request them. Hopefully, seeing the results will reassure you that you are not alone.

Other Pandemics

History shows us again and again that we are not alone. The world has always experienced widespread traumas — and now, it seems, it is our turn.

Fortunately, COVID-19 is not the Plague of Justinian, which killed half the people in the world, or the Black Death (bubonic plague), which killed at least one-third of Europe’s population. Projections for COVID-19 are nowhere near as deadly.  

Our forebears have been through other crises, although they were not of the magnitude of the two plagues. Many of them lived to tell their children and grandchildren about them, as we’ve experienced in our own families.

My paternal grandfather was my lifelong hero. He was strong and selfless, and he worked hard to take care of his family. He did everything necessary and more, without ever questioning why or complaining about the unfairness of life.

He and my grandmother lived through the 1918 Spanish Flu pandemic, which sickened and killed tens of millions of people during World War One. Doctors had no anti-viral medications or vaccines at the time.

Social distancing worked, fortunately, for the cities that practiced it. However, there were few other tools society could count on to cope with the pandemic. Beyond social distancing and masks, survival was a matter of luck more than anything else.

My parents endured the stock market crash of 1929 and the Great Depression. They also lived through World War II. Like all Americans, they experienced rationing of "luxury" items such as meat, sugar and gasoline. They hoped and trusted that their children, and their children's children, would never have to suffer the terror and deprivation they had faced.  

They hoped in vain. My siblings and I experienced the Vietnam War and the first Gulf Conflict in 1990. We saw the Twin Towers fall on September 11, 2001 and watched that lead to wars in Afghanistan and Iraq,

We lived through the AIDS epidemic. We saw a mass shooting at Columbine in 1999, and then we watched as Sandy Hook and other schools in the United States also became scenes of carnage. We witnessed thousands of people needlessly lose their lives.  We also experienced two major stock market declines, the first in 1987 and the second in 2008.

My wife and I assumed, perhaps as you did, that we would never face life challenges as great as those our parents and grandparents endured. We were wrong. Along with our children, grandchildren and the rest of the world, we now face a pandemic that has already caused over 100,000 deaths, closed businesses and created mass unemployment.  

What Lies Ahead

It may be too early to predict the eventual toll this will take on human lives. The resultant economic disaster could lead to another depression. Some estimate that the U.S. could see more than 30% unemployment -- far exceeding the joblessness of the Great Depression. For those who survive, it may take years for their personal finances and retirement savings to recover. 

This feels different from everything we have read about in history books. Tragedies are only stories until they happen to you. 

People with chronic illnesses, those who are under-insured or uninsured, and healthcare workers who are on the front lines risking their lives every day will likely be hit the hardest. However, this horror affects all of us. We find ourselves socially isolated, financially challenged, frightened for our loved ones, worried about the unknown, and perhaps dealing with serious illness.  

The lack of access to healthcare, medications and even the basic necessities of life will impact our physical and mental health. Even if we ourselves aren't suffering, people we care about certainly are. 

However, it is times like this that can bring us together to fight a common enemy. The acts of decency, bravery, creativity and generosity we see everyday should inspire us. If you follow #upworthy on Instagram, you can see hundreds of examples.  

Someday, our children’s children will read about COVID-19 in history books. Surveys are one way we can record our challenges, feelings and responses to these extraordinary days. Please take this survey and share the link widely. Thanks, and be well. 

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

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

Frequent Cannabis Use Linked to High Pain Levels

By Pat Anson, PNN Editor

People who use medical marijuana multiple times a day are more likely to have high levels of chronic pain, but that may be a reflection of other health problems, according to a new study.

The study, recently published in the International Journal of Drug Policy, is based on a survey of 295 medical marijuana dispensary patients in Los Angeles in 2013. Participants were asked about their pain levels, how often they used marijuana, and how their current health status compared to a year earlier.

Those who reported high levels of pain were more likely to use cannabis three or more times a day, but researchers say they could also be using cannabis for conditions such as nausea, anxiety and insomnia.

"It may not be the pain that patients are trying to address," said lead author Alexis Cooke, a postdoctoral scholar in psychiatry at the University of California, San Francisco. "Having high chronic pain is related to poorer health, so it may be that people who are using marijuana more often already had worse health to begin with.

"Chronic pain is also associated with depression and anxiety. Marijuana may help with these problems for some people, even if it doesn't help with the pain.”

Among those surveyed, 31% reported high pain levels, 24% had moderate pain, and 44% were in the low-pain category.

The percentage of participants who used marijuana daily did not differ by pain category. But about 60% of those who reported high pain used cannabis three or more times a day, compared to 51% of those with moderate pain and 39% of those in the low-pain group.

The findings showed no association between daily marijuana use and changes in health status for those with low levels of pain. But daily marijuana use was linked to worsening health for people with high pain levels.

"It's not clear if marijuana is helping or not," said co-author Bridget Freisthler, a professor of social work at The Ohio State University. "The benefits aren't as clear-cut as some people assume."

"It shows how little we know about marijuana as medicine, how people are using it, the dosages they are receiving and its long-term effects."

While the findings are mixed, the authors concluded that for cannabis, “the best available evidence suggests a possible benefit for the treatment of chronic pain.”

It all may boil down to how much tetrahydrocannabinol (THC) -- the psychoactive ingredient in marijuana – is in the cannabis people are consuming.

A recent survey of nearly 3,000 cannabis users by researchers at the University of New Mexico found that those who used whole cannabis flowers or buds rich in THC reduced their pain levels an average of three points on a 0 to 10 pain score. Surprisingly, those who ingested cannabidiol (CBD) did not experience similar pain relief.

An earlier study by the same researchers found that cannabis also provides relief from insomnia, seizures, depression, anxiety and fatigue. That study also found that THC was more important than CBD in generating therapeutic benefits.

FDA Approves Stem Cell Trials for Coronavirus

By A. Rahman Ford, PNN Columnist

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

I Was Lied to by My Pharmacist

By Colleen Sullivan, Guest Columnist

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

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

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

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

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

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

COLLEEN SULLIVAN

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

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

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

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

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

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

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

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

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

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

JUST DRIVE AROUND AND LOOK FOR IT?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Colleen Sullivan lives in Florida.  

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

DEA Allowing More Production of Opioids

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

Shortages Began Before Coronavirus

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

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

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

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

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

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

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

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

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

Surgery Patients Face Delays as Coronavirus Cripples Hospitals

By Will Stone, Kaiser Health News

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Hospitals Prioritize Urgent Cases

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

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

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

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

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

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

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

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

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

No Single Standard

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

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

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

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

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

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

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

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

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

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

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

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

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

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