Pain Warriors: A Civil Rights Movement for Our Time

By Pat Anson, PNN Editor

A long-awaited documentary about chronic pain in North America is shining a light on the other side of the opioid crisis – how chronic pain patients and their doctors have been marginalized and persecuted in the name of fighting opioid addiction.

“Pain Warriors” is being released by Gravitas Ventures. It is available for streaming on Vimeo, iTunes and Amazon Prime or on DVD.

The 80-minute film takes an intimate look at the lives of four chronic pain patients and their loved ones, including an 11-year old boy living with cancer pain and a doctor who nearly lost his medical license due to allegations he overprescribed opioids.

Two of the “pain warriors” featured in the documentary commit suicide after losing all hope that their pain will be properly treated.   

“That captures the essence of our film -- invisible, shunned and disbelieved. This is the story of their fight. Pain Warriors is a civil rights movement for our time,” says Tina Petrova, who produced and directed the documentary along with filmmaker Eugene Weis.  

“Doctors have been incarcerated, committed suicide, gone broke standing up for appropriate treatments for intractable pain. Families have lost loved ones due to suicides from chronic pain and medical complications such as spinal leaks. This is no small disease. It steals husbands and wives, sons and daughters.”

Pain Warriors is dedicated to Sherri Little, a California woman who took her life at the age of 53 after a last desperate attempt to get treatment for her fibromyalgia and colitis pain. (See “Sherri’s Story: A Final Plea for Help”). Sherri was a good friend of Petrova, who is well-acquainted with the issues faced by chronic pain patients – because she’s one herself.

“I began pre-interviews for the film around 2014, gathering collections of heartbreaking, compelling stories. A pain patient struggling with her own pain demons donated money to the cause, wanting her story told alongside others, and we began making the film in earnest,” she told PNN.

“Has it been easy? I’d say it’s been a hell of a lot of painstaking work by all involved, including the cast, who bravely offered up their vulnerability and very intimate stories. Has it been worth it? Absolutely.”

You can see a preview of Pain Warriors here:

The release of Pain Warriors was initially delayed due to funding problems, and then because Petrova suffered a severe back injury during physical therapy. She was bedridden and housebound for over a year.

“I’m hopeful that I’m on the mend at long last, and will be able to take the film across North America, once COVID restrictions are lifted, and lead in-person screenings with the people the film was made for -- chronic pain patients and the healthcare professionals that sometimes risk everything fighting for their rights,” says Petrova.

Dr. Mark Ibsen plays a prominent role in the film. The Montana Board of Medicine suspended Ibsen’s medical license in 2016, a decision that was reversed two years later when a judge ruled the board made numerous procedural errors.

Ibsen’s legal battles have not ended. The Board of Medicine has refused to formally close his case, leaving Ibsen in professional limbo. Pharmacists won’t fill his opioid prescriptions and he was forced to close his urgent care clinic in Helena. Now he travels the back roads of Montana writing prescriptions for medical marijuana.

“I’ve been marginalized,” says Ibsen, who plans to sue the Board of Medicine for monetary damages. “Anything the board would say would not completely clear me. I need the judge to say, ‘This is bogus. Stop it. Dismiss the case.’”   

Pain Warriors is featured in PNN’s Suggested Reading section, where you can buy the DVD through Amazon.

Study Finds Limited Evidence to Support Use of Non-Opioid Drugs for Chronic Pain

By Pat Anson, PNN Editor

A new study by federal researchers has found limited evidence to support the use of non-opioid medications in treating chronic pain conditions such as fibromyalgia, neuropathy, rheumatoid arthritis and low back pain.

Only small improvements in pain and function were found in the use of anti-convulsants and non-steroidal anti-inflammatory drugs (NSAIDs), while moderate improvement was found in the use of some antidepressants.

Researchers noted that evidence was “too limited to draw conclusions” on long-term use of non-opioid drugs, and “no treatment achieved a large improvement in pain or function.” They also cautioned that “careful consideration of patient characteristics is needed in selecting nonopioid drug treatments” because of the risk of side effects.

The report was prepared for the Agency for Healthcare Research and Quality (AHRQ) by the Pacific Northwest Evidence-based Practice Center (EPC) at Oregon Health & Science University. The EPC has recently finalized two other studies on the use of opioids and nonpharmacological treatments for chronic pain.

Unlike their report on opioids, EPC researchers did not consult with technical experts and peer reviewers associated with Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

The researchers analyzed nearly 200 clinical studies and systematic reviews of non-opioid medication. Only 25 of the studies were rated as good quality and only 8 lasted a year or more. The pharamceutical industry funded 82 percent of them.

The EPC report is more cautious than other federal studies on the use of non-opioids such as pregabalin (Lyrica) and gabapentin (Neurontin).  Side effects from those drugs were often so severe that some patients stopped taking them and dropped out of clinical studies.

“Large increases in risk of adverse events were seen with pregabalin (blurred vision, cognitive effects, dizziness, peripheral edema, sedation, and weight gain), gabapentin (blurred vision, cognitive effects, sedation, weight gain), and cannabis (nausea, dizziness),” EPC researchers found. “Dose reductions reduced the risk of some adverse events with SNRI antidepressants. In the short term small increases in risk of major coronary events and moderate increases in serious gastrointestinal events (both short and long term) were found with NSAIDs.”

The EPC study is in marked contrast to the 2016 CDC opioid guideline, which recommends pregabalin, gabapentin and NSAIDs as alternatives to opioids with little to no mention of their side effects.

Other researchers have also warned that the effectiveness of gabapentin and pregabalin, which belong to a class of anti-convulsant drugs known as gabapentinoids, is often exaggerated in prescribing guidelines.

“Gabapentinoids have become frequent first-line alternatives in patients with chronic pain from whom opioids are being withheld or withdrawn, as well as in patients with acute pain who traditionally received short courses of low-dose opioid,” researchers at the University of South Carolina School of Medicine warned in a 2019 study.

“The evidence to support off-label gabapentinoid use for most painful clinical conditions is limited. For some conditions, no well-performed controlled trials exist.”

The EPC’s trio of studies on opioids, non-opioid drugs and non-pharmacological treatments are expected to help guide the CDC as it prepares an update and expansion of its 2016 opioid guideline, which is expected in late 2021. The update is likely to include new guidelines for treating short term, acute pain.  

How will CDC interpret the EPC findings on opioids and non-opioids? One outcome is suggested in the opioid study.

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

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.

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.

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.”

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

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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

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

PAUL GILENO

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

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

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

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

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

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

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

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

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

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

Coronavirus Is Now More Deadly Than Opioid Crisis

By Roger Chriss, PNN Columnist

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

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

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

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

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

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

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

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

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

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

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

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

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

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

AMA: Waive Limits on Opioids During Coronavirus Emergency

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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

Medicare Plan Would Require Insurers to Report Suspicious Opioid Prescribing

By Pat Anson, PNN Editor

Doctors, patients and advocates are reacting with alarm to a proposal by the Centers for Medicare and Medicaid Services (CMS) that would require insurance companies to report “substantiated or suspicious activities” by healthcare providers, including “inappropriate prescribing of opioids.” Insurers would also be authorized to unilaterally suspend payments to pharmacies for “credible allegations of fraud.”

If adopted, critics say the sweeping rule changes would have a chilling effect on providers and put insurance company profits ahead of patient well-being.

At issue is a notice published in the Federal Register last month, which details changes proposed for Medicare and Medicaid programs for 2021 and 2022. The notice has drawn little attention from the public, news media or healthcare organizations, which have been preoccupied with the coronavirus pandemic.

Many of the rule changes proposed by CMS are being made to implement the SUPPORT Act, which was passed by Congress in 2018 to reduce opioid abuse and promote substance abuse treatment.

Current CMS policy allows insurers – known as “plan sponsors” -- to voluntarily report potential fraud by doctors and pharmacists. The proposed rule change would require such reporting, when there is “credible evidence of suspicious activities of providers or suppliers related to fraud, and other actions taken by the plans related to inappropriate opioid prescribing.”

Insurers would report allegations to CMS through an internet portal, while the public would be encouraged to call a fraud tip hotline. Credible cases of “bad actors” would then be referred to law enforcement, according to CMS:

"Implementing these provisions will allow CMS, MA (Medicare Advantage) organizations and Medicare Part D plan sponsors to share data and information regarding bad actors, take swift action based on such data and information, and achieve enhanced outcomes in our efforts to fight the opioid crisis. In addition, this regulation will provide the means for more effective referrals to law enforcement based on plan sponsor reporting, ultimately resulting in reduced beneficiary harm and greater savings for the Medicare program.” 

Insurers would be allowed to consider a wide range of factors to determine if opioid prescriptions are inappropriate, including a patient’s health condition, medical records, opioid dosage, refills, and even the “time and distance between a prescriber and the patient.”

Patient advocates say the plan gives too much power to insurers and wrongly assumes that prescription opioids play a major role in the opioid crisis.

“The regulations planned here will constitute a major regulatory burden on the practice of medicine and implicitly make the assumption that sponsors or pharmacists are better judges of patient benefit and risk than prescribers,” said Andrea Trescot, MD, Stephen Nadeau, MD, and patient advocate Red Lawhern, PhD, in a joint statement. 

“These rule changes assign major responsibilities and powers to Medicare Part D sponsors. Since these sponsors have a pecuniary interest in minimizing the drugs they pay for, profit rather than patient well-being will be the major driver of their procedures and protocols. Both physicians and advocates spend hours each week dealing with denial of care, including medications, by sponsors. The people denying the care are often not physicians and they make no attempt to access patient medical records to develop informed judgments.”

Under the CMS proposal, insurers would also be required to enroll patients deemed at risk for opioid abuse into “Drug Management Programs” that would limit which doctors and pharmacies they can see to obtain prescriptions for opioids and benzodiazepines, a class of anti-anxiety medication.  

‘Big Brother’ Approach

Although the CMS proposals have been publicly available on the Federal Register for over a month, only a few dozen comments have been received to date.

“This sounds like we (chronic pain patients) will be targeted for simply getting the care we need to sustain a basic level of living,” wrote one poster. “Often times, assumptions are made that we are drug seekers, drug abusers, and such. Sometimes it takes trying different medications and different doses to get to where we need to be in order to live life. This may look bad on paper to someone without clinical training, education, or experience. Things aren't always what they seem.” 

“My gosh you people are trying to fix a non-existent problem. The issue now is not prescription drugs that us senior citizens take. It is heroin and fentanyl analogs,” said another. “IT IS TIME WE AS A COUNTRY STOP TRYING TO FIX A MEDICAL ISSUE WITH LAW ENFORCEMENT. There is no need for the government to get between me and my doctor when it comes to my pain medication.”

Many posters are concerned that providers and patients could face sanctions over unproven allegations.

“I am EXTREMELY concerned for this ‘Big Brother’ approach you are taking yet again,” said another poster. “I do not have an addictive personality. What if someone decides to say I do? Then my doctor who is already living in fear of the DEA may go along with whatever determination this government decides to make about me.”   

“So the idea is to shut down doctors with a mere investigation? Based on accusation? Not even charged but only accused? This is truly a new low in individual rights,” said another. “I would think that doctors would almost entirely abandon controlled substances prescribing altogether. Perhaps the motivation for this.”  

While CMS says “a fraud hotline tip, without further evidence, is not considered a credible fraud allegation,” some worry that unsubstantiated claims could still result in sanctions against a provider.   

It was a complaint from a woman in upstate New York that recently led to a North Carolina doctor losing his DEA license. The woman doesn’t know Dr. Thomas Kline or any of his patients, but reported Kline to the state medical board because she didn’t like his tweets defending the use of opioid medication. Kline sees several patients from out-of-state, one of the red flags that CMS would consider suspicious.

“I think the sticky wicket is probably the words ‘credible allegations of fraud.’ Such as the Dr. Kline fiasco. THAT wasn't credible but the Board sure made it out to be,” says Rick Martin, a retired pharmacist and pain patient.   

What do you think of the CMS proposal? The public comment period ends April 6. To leave a comment, click here.

What If the Opioid Crisis Is Worse Than We Think?

By Roger Chriss, PNN Columnist

A recent study in the journal Addiction reports that the opioid crisis in the U.S. may be worse than we’ve been led to believe. The number of overdose deaths linked to legal and illicit opioids over the past two decades could be about 28 percent higher than reported.

Economists Andrew Boslett, Alina Denham and Elaine Hill looked at drug overdose deaths between 1999 and 2016 in the National Center for Health Statistics. Of 632,331 deaths, over one in five had no information on the drugs involved. The researchers estimated that as many as 72% percent of those deaths likely involved opioids. This yields an additional 99,160 deaths involving prescription opioids, heroin, fentanyl and other street drugs that were not counted.

This estimate may or may not be right, but it is definitely not new. Claims like this have been around for years.

In 2017, Business Insider reported on an investigation by CDC field officer Dr. Victoria Hall, who looked at the Minnesota Department of Health's Unexplained Death (UNEX) system. She found that 1,676 deaths in the state had “some complications due to opioid use,” but were not reported as opioid-related deaths.

A 2018 study at the University of Pittsburgh found that as many as 70,000 overdose deaths were missed because of incomplete reporting.

‘Cooking the Data’

It has long been suspected that the CDC’s opioid overdose death toll is faulty – either too high or too low, depending on your point of view. Public health data in the U.S. is shoddy, the result of a fractured and fragmented system that has little central guidance or administrative oversight. The overdose numbers aren’t as reliable as they should be, which raises suspicion they are being manipulated.

The Atlantic makes a similar point about the coronavirus outbreak.

"Everyone is cooking the data, one way or another. And yet, even though these inconsistencies are public and plain, people continue to rely on charts showing different numbers, with no indication that they are not all produced with the same rigor or vigor," wrote Alexis Madrigal. “This is bad. It encourages dangerous behavior such as cutting back testing to bring a country’s numbers down or slow-walking testing to keep a country’s numbers low.”

The implications of under-counting deaths in the overdose crisis require careful consideration. Political campaigns, public policy, state laws and regulations, and clinical practice are built on these numbers. For instance, the Trump administration was recently touting a 4% decline in overdose deaths, but that reduction may not exist.

Similarly, cannabis advocacy groups argue that state legalization has reduced overdose deaths. But again, that reduction may evaporate with better data. State laws and regulations are built on the assumption that trend lines were going in a particular direction. But maybe they aren’t.

Most important, policy groups have argued strenuously that reducing prescription opioid utilization would alleviate the overdose crisis. But if there are vastly more deaths than recognized, where does that leave these groups?

Of course, determining cause of death is a process fraught with difficulties. The New York Times reports that morgues are overburdened and understaffed, many suspected overdose deaths are not fully evaluated, and reporting on the cause of death is not standardized.

Making a probabilistic assessment is even more fraught. For instance, a recent attempt to use stool samples to measure how many rodents, birds and other wildlife are eaten by domestic cats was undone by the discovery that cat food manufacturers regularly change their ingredients.

In other words, there are many known problems and occasional surprises in public health data, so any estimate has to be treated with caution. But if opioid overdoses are vastly undercounted, then we should reassess the policies and politics of the crisis.

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.

DEA Allowing Telehealth for Opioid Prescriptions

By Pat Anson, PNN Editor

Pain patients who are self-isolating during the coronavirus outbreak may be able to get an opioid prescription without visiting their doctor.

In an update on its COVID-19 Information Page, the U.S. Drug Enforcement Administration said prescribers and patients can connect remotely via telehealth – also known as telemedicine --  to get a prescription for opioids and other controlled substances.  

The exemption from the Controlled Substances Act was made possible by the public health emergency declared on January 31 by Health and Human Services Secretary Alex Azar.  On March 16, Azar and Acting DEA Administrator Uttam Dhillon agreed to allow telemedicine to be used for the prescribing of Schedule II through Schedule V opioids and other controlled substances.

“While a prescription for a controlled substance issued by means of the Internet (including telemedicine) must generally be predicated on an in-person medical evaluation, the Controlled Substances Act contains certain exceptions to this requirement,” the DEA said.

“For as long as the Secretary’s designation of a public health emergency remains in effect, DEA-registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation.”

The exemption applies to both new prescriptions and renewals, provided the following conditions are met:

• The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of their professional practice.

• The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system

• The practitioner is acting in accordance with federal and state laws.

Doctors were already allowed under federal law to use telehealth to prescribe controlled substances, but only if they had previously conducted an in-person medical evaluation of the patient. The exemption essentially waves that first face-to-face meeting.

“During this uncertain time, DEA remains flexible and committed to ensuring that the nation’s drug supply chain is uninterrupted,” Dhillon said in a statement. “DEA continues to work with our public health partners to explore options that ensure those in need of vital prescriptions are able to get them, while still adhering to safe practices such as social distancing.”

‘Unaware of Any Shortages’

The DEA also said it was working with the FDA to monitor the supply of medications and was “unaware of any shortages of controlled substances at this time.”

That is a misleading statement, because there are 145 drugs currently listed in an FDA database of drug shortages, including several opioids that are primarily used for anesthesia during medical procedures. The drugs were in short supply even before the coronavirus outbreak.

Last month, the FDA said it was notified by a drug manufacturer that it was experiencing a shortage of one medication due to the coronavirus outbreak. The drug was not identified.

Many ingredients and raw materials used in drug manufacturing are imported from China and India. According to a recent study, nearly two-thirds of the world’s supply of acetaminophen comes from China.

Emergency Refills

Some states are also taking steps to ensure that patients are not deprived of medications during the coronavirus outbreak.

Florida Surgeon General Scott Rivkees issued an emergency order authorizing the use of telemedicine for prescribing opioids and other controlled substances “only for an existing patient for the purpose of treating chronic nonmalignant pain without the need to conduct a physical examination.”

This Washington State Medical Commission authorized pharmacists to grant emergency 72-hour refills for prescriptions that are not maintenance medications. A 30-day emergency supply of maintenance medications was authorized if a pharmacist is unable to obtain refill authorization from the prescriber.

Maintenance medications are drugs used to treat conditions that are chronic or long-term, such as high blood pressure, heart disease, diabetes and, presumably, chronic pain.

The Washington State Department of Health also asked insurance companies to allow patients to get a one-time refill of their prescriptions before the end of the waiting period between refills.

Overdose Deaths Fell by 4.1% in 2018

By Pat Anson, PNN Editor

A new analysis by the CDC has confirmed earlier estimates that drug overdose deaths in the U.S. decreased by 4.1% in 2018, the first decline in the nation’s overdose rate in nearly three decades.

The decline was led by a drop in overdoses involving prescription opioids (-13.5%) and heroin (-4.1%). Much of that progress was offset by a 10% increase in deaths involving synthetic opioids, a category that includes illicit fentanyl and fentanyl analogs.

Fentanyl and other synthetic opioids were involved in 31,335 overdose deaths -- nearly half of the 70,237 drug deaths in 2018 and over two-thirds of the 46,802 opioid deaths.

The 14,975 deaths linked to prescription opioids represent about 22% of the total number of fatal overdoses.

“Decreases in overdose deaths involving prescription opioids and heroin reflect the effectiveness of public health efforts to protect Americans and their families,” CDC Director Robert Redfield, MD, said in a statement. “While we continue work to improve those outcomes, we are also addressing the increase in overdose deaths involving synthetic opioids. We must bring this epidemic to an end.”

U.S. DRUG OVERDOSE DEATHS IN 2018

SOURCE: CDC

Synthetic opioid deaths in 2018 increased in the Northeast, South and West and remained stable in the Midwest. The highest synthetic opioid death rate (34 deaths for every 100,000 people) occurred in West Virginia, which also has the highest death rate involving prescription opioids (13.1 deaths per 100,000 people).

Seventeen states experienced declines in prescription opioid deaths in 2018, with no states experiencing significant increases.

While opioid prescribing has been declining since 2012, much of the CDC’s public messaging remains focused on reducing the use of opioid pain medication.

“Because of the reductions observed in deaths involving prescription opioids, continued efforts to encourage safe prescribing practices, such as following the CDC Guideline for Prescribing Opioids for Chronic Pain might be enhanced by increased use of nonopioid and nonpharmacologic treatments for pain,” wrote Nana Wilson, PhD, a CDC epidemiologist and lead author of the study.

“Additional public health efforts to reduce opioid-involved overdose deaths include expanding the distribution of naloxone, addressing polysubstance use, and increasing the provision of medication-assisted treatment.”

Wilson and her colleagues noted that an increase in overdose deaths among African-American and Hispanics showed a need for “culturally tailored interventions” to address health and other societal factors.   

While the decline in overdose deaths in 2018 is encouraging, preliminary CDC data indicates the trend is not continuing into 2019. Deaths are increasing from synthetic opioids, cocaine, methamphetamine and psychostimulants such as attention deficit disorder drugs.

Overdose deaths often involve multiple drugs, so a single death might be included in more than one category and be counted multiple times. The quality of the data also varies widely from state to state. Only 39 states have good to excellent overdose data, according to the CDC.

Confusion Over Ibuprofen as Coronavirus Treatment

By Pat Anson, PNN Editor

With the number of coronavirus cases growing to nearly 200,000 worldwide, so is confusion about which over-the-counter pain reliever should be used to treat its symptoms. Some health experts say acetaminophen – known as paracetamol outside the U.S. – is better than ibuprofen, aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

"We recommend paracetamol, not ibuprofen for self-medicating," Christian Lindmeier, a spokesman for the World Health Organization said today.

At issue is whether ibuprofen and other NSAIDs interfere with the body’s immune system and make coronavirus symptoms worse. The debate was kicked off Saturday by a tweet from France’s Health Minister.

“Taking anti-inflammatory drugs (ibuprofen, cortisone, ...) could be an aggravating factor of the infection. If you have a fever, take paracetamol,” said Dr. Olivier Véran, a neurologist.

That same day, the French government reported "grave adverse effects" linked to the use of NSAIDs in coronavirus patients and released new guidelines saying “the treatment of a fever or of pain linked to COVID-19 or to any other respiratory viral disease should be paracetamol.”

But the UK’s Royal Pharmaceutical Society (RPS) disputed whether there was enough evidence to make such a recommendation.

“There is not currently enough information on ibuprofen use and COVID-19 to advise people to stop using NSAIDs. There is currently no published scientific evidence that ibuprofen increases the risk of catching COVID-19 or makes the illness worse. In addition, there is also no conclusive evidence that taking ibuprofen is harmful for other respiratory infections,” the RPS said in a statement.

The Medical University of Vienna also chimed in, calling reports that it had found a connection between ibuprofen use and worse coronavirus symptoms "fake news."

But other experts agreed that NSAIDs can weaken the immune system.

“Despite all of their beneficial effects, it has long been known that anti-inflammatories can have a depressive effect on parts of our immune systems,” Dr. Amir Khan of Britain’s National Health Service said in Al Jazeera. “If we take medicines that dampen this immune response, such as ibuprofen, this can lead to us not fighting off the infection as effectively, potentially leading to a longer illness with a higher risk of complications.

“Paracetamol is not an anti-inflammatory medication and can be used to effectively treat fever as well as mild to moderate pain and can, therefore, be used safely to help treat the fever associated with the coronavirus.”

The NHS also updated its recommendations, cautioning that while there is no strong evidence that ibuprofen makes coronavirus worse, “until we have more information, take paracetamol to treat the symptoms of coronavirus.”

‘Don’t Give Her Ibuprofen!’

The New York Post reported that a 4-year old British girl suffering coronavirus symptoms had difficulty breathing and took a turn for the worse after taking ibuprofen. Amelia Collins had a cough, fever and other flu-like symptoms.

“To those of you that have children please read. If your child has symptoms of corona virus, DO NOT give them ibuprofen,” Amelia’s father posted on Facebook. “Within an hour of giving her [ibuprofen] she dropped dramatically. She was panting while trying to breathe, her heart rate was very rapid, she couldn’t keep her eyes open, couldn’t lift her head up, her body was shaking, she started being sick on herself and her temperature had risen.”

Amelia’s parents called for an ambulance. Fortunately, paramedics were able reduce her fever without taking her to a hospital.

“Now she’s back on [acetaminophen] she’s back to just being her poorly self. The paramedics only told us while here that were not to give her ibuprofen!” the father said.

In 2015, the U.S. Food and Drug Administration warned that “everyone may be at risk” and ordered new warning labels for ibuprofen and other NSAIDs to indicate they increase the risk of a fatal heart attack or stroke.

But acetaminophen also has issues. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. Acetaminophen is the active ingredient in hundreds of over-the-counter pain relievers and cough, cold and flu medicines – and many consumers have no idea how much acetaminophen they’re taking.

Over 50,000 emergency room visits each year in the U.S. are blamed on acetaminophen overdoses, including 25,000 hospitalizations and hundreds of deaths.