What Next for CDC Opioid Guideline?

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By Pat Anson, PNN Editor

The pain community is reacting with a fair amount of skepticism to efforts by the CDC to address the widespread misuse of its 2016 opioid prescribing guideline.

A CDC commentary published Wednesday in The New England Journal of Medicine warns against the “misapplication” of the guideline, which has resulted in hard dosing limits, forced tapering and the medical abandonment of thousands of chronic pain patients.

Although the guideline strongly recommends that daily doses of opioids not exceed 90 MME (morphine milligram equivalent), the guideline’s three co-authors say their advice was misinterpreted and that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages.”

A CDC media statement this week also claimed “the guideline does not support abrupt tapering or sudden discontinuation of opioids.” 

That was surprising news to Rob Hale, a Missouri man with late-stage Ankylosing Spondylitis, a degenerative and incurable form of arthritis.  Like many other pain patients, Hale’s relatively high dose of opioid medication was significantly reduced soon after the guideline’s release.  As a result, he is now bedridden.

“This is amazing news, if they really intend to follow through with it,” said Hale in an email. “God, I hope this is the beginning of a turnaround in prescribing policies.  I just feel for the hundreds of us who gave up and took their lives or died as a result of the last 3 years of cruelty.”

Saving Face

Why the CDC is acting now is unclear. Reports of patient harm began circulating soon after the guideline’s release in March 2016, and have only accelerated as insurers, pharmacies, states and practitioners adopted the guideline as mandatory policy. In a recent PNN survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide.

“I regard this CDC statement to be an effort to save face and maintain political dominance on an issue into which CDC improperly inserted itself under the influence of Andrew Kolodny and PROP,” said patient advocate Richard “Red” Lawhern, referring to the founder of the anti-opioid activist group Physicians for Responsible Opioid Prescribing.

“The statement fails to engage with the underlying issues which render the Guidelines fatally flawed.  It fails to acknowledge the essential repudiation of the entire guideline concept by the American Medical Association, plus multiple prominent medical professionals.” 

“The CDC guidelines have been as harmful as predicted, and the silence over 3 years has been criminal. The ‘Who me?’ response is just as evil as the ignorant abuse of power that led to the crisis in the first place,” said Mark Ibsen, MD, a Montana physician whose license was suspended by the state medical board for “overprescribing” opioids. A judge overturned the board’s ruling.  

“Those who give a weak ‘mea culpa’ for misinterpretation of the guidelines are, in short, lying. The deaths of thousands of abandoned pain patients, including 6 of mine who lost access (to opioids), are on their hands,” Ibsen said. 

PNN asked a CDC spokesperson if the agency had received new information about patients being harmed by the guideline and received a vague response.  

“We have heard concerns from partners and stakeholders about policies and practices that are inconsistent with the 2016 Guideline and sometimes go beyond its recommendations. The misapplication of the Guideline can risk patient health and safety,” Courtney Lenard said in an email. “CDC authored this commentary to outline examples of misapplication of the Guideline, and highlight advice from the Guideline that is sometimes overlooked but is critical to safe and effective implementation of the recommendations.” 

The response was also vague when we asked if CDC would be directly contacting insurers, pharmacies and states to warn them about misapplying the guideline.

“CDC has engaged payers, quality improvement organizations, state health departments, and federal partners to encourage implementation of recommendations consistent with the intent of the Guideline,” said Lenard, citing a mobile app and a pocket guide to opioid tapering as examples of CDC outreach.

The agency also sent out a Tweet.

Lenard gave no indication that a revision of the guideline was imminent. She said the CDC was working with the Association of Healthcare Research and Quality (AHRQ) to evaluate “new scientific evidence” about the benefits and harms of opioids.  

“Results of these reviews will help CDC decide whether evidence gaps have been addressed and whether the Guideline should be updated or expanded for chronic or acute pain prescribing,” Lenard wrote. 

Undoing the Damage

The American Medical Association – which took a stand against the “inappropriate use” of the guideline last year -- released a statement saying the CDC needed to work more closely with insurers.

“The guidelines have been misapplied so widely that it will be a challenge to undo the damage. The AMA is urging a detailed regulatory review of formulary and benefit design by payers and PBMs (pharmacy benefit managers),” said AMA President-elect 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.”

Dr. Ibsen said the Drug Enforcement Administration was “the other elephant in the room” because it has weaponized the CDC guideline to demonize and prosecute doctors for prescribing high opioid doses. 

“Arresting and punishing doctors who treat the sickest pain patients. Civil asset forfeiture as used in dealing with criminal drug dealers. Equate physicians with a license to practice as equal to or below said criminal drug dealers,” said Ibsen, listing some of the tactics used by prosecutors.

“Charge physicians with one felony for every Rx they write, making absurdly dramatic charging documents and headlines against doctors who are left with no income or assets to defend themselves in a contaminated jury pool. Charge doctors with murder for prescribing medications to patients who fail to follow the directions.”

It’s not just the DEA. The National Association of Attorneys General recently declared that the dose and duration of opioid prescriptions should not be decided by doctors and that the CDC guideline should essentially be treated as law.

“As a matter of public safety, there is simply no justification to move away from the CDC Guideline to encourage more liberal use of an ineffective treatment,” warns a letter signed by 39 state and territory attorney generals. “As Attorneys General of states with high rates of prescription drug abuse among our youth, policy makers and prescribers must be encouraged to continue to pursue laws and practices that reduce the high volume of opioids in our communities.”

“The standard of care is now determined by prosecutors and juries,” says Ibsen.

Pain Clinics Ordered Unnecessary Urine Drug Tests

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By Fred Schulte, Kaiser Health News

A Tennessee-based chain of pain clinics that abruptly shut down last summer faces five whistleblower lawsuits accusing it of defrauding Medicare and other health insurers by billing for hundreds of unnecessary urine drug tests and other dubious health services, newly unsealed court records show.

The federal suits target Tennessee-based Comprehensive Pain Specialists, also known as Anesthesia Services Associates, PLLC, and several of its physician owners. At its peak, CPS ran 60 pain clinics in 12 states, according to the suits, as well as a lucrative urine-testing lab in Brentwood, Tenn. CPS closed with no warning in July, leaving patients in several states distressed and scrambling to find a new source of narcotic pain medicines.

In federal court filings unsealed in Nashville this week, federal prosecutors said they would take over the urine-testing allegations and sue several CPS owners, including co-founding anesthesiologists Peter Kroll and Steven Dickerson. Dickerson is a Republican state senator representing Nashville.

Kroll could not be reached for comment Wednesday. Dickerson did not respond to an email or a phone message left at his legislative office.

It is not clear whether the whistleblowers, who include former CPS doctors and other employees, would pursue several allegations against the company that the federal government declined to join in. CPS, in an unrelated court filing in December, said the company had terminated all of its employees and that debts “greatly exceed its assets.”

Once among the largest pain management groups in the Southeast, CPS crumbled amid financial woes that included nearly a dozen civil suits alleging unpaid debts, and a criminal investigation that ensnared its former chief executive, John Davis. Davis, 41, was convicted this month in federal court in Nashville on health care fraud charges. He is to be sentenced later this year.

CPS was the subject of a November 2017 investigation by Kaiser Health News that scrutinized its Medicare billings for urine drug tests. Medicare paid the company at least $11 million for urine screenings and related tests in 2014, when five of CPS’ medical professionals stood among the nation’s top such Medicare billers. One nurse practitioner working at a CPS clinic in Cleveland, Tenn., generated $1.1 million in urine-test billings that year, according to Medicare records analyzed by KHN.

Kroll, who also served as CPS’ medical director, said at the time that the tests were justified for patient safety and to reduce chances the pills might be sold on the black market. Kroll billed Medicare $1.8 million for urine tests in 2015, the KHN analysis of Medicare billing records found.

Kroll in an interview with KHN at the time said that he and fellow anesthesiologist Dickerson came up with the idea for the pain clinics over a cup of coffee at a Nashville Starbucks in 2005.

One of the whistleblower suits alleging unnecessary urine tests was first filed under seal in 2016 by Suzanne Alt, a doctor who worked in the company’s pain clinics in Troy, Mo., and Keokuk, Iowa, from May 2014 to March 2015. She alleged CPS doctors were “strongly encouraged to order full-panel urine drug screens on each patient, every time, despite the patient’s history, compliance and risk.”

She also said that the company’s electronic medical records “made it extremely difficult to order anything less than the full panel.” Alt said she was told the Tennessee lab did about 600 of these screens daily. Another whistleblower said he toured the lab with CPS executives and observed an “overpowering and unpleasant smell of urine.” In response, a CPS executive said, “To me, it smells like money,” according to the suit.

“They were making a killing,” said Birmingham, Ala., attorney Don McKenna, who represents Alt in the case.

Another of the whistleblowers, former CPS anesthesiologist Cynthia Niendorff, alleged that the company billed Medicare about $754 for each additional urine test, even though earlier results had come back negative. She said CPS grossed approximately $6 million per month from the urine-testing lab and said about 20% of this amount was suspect, according to the suit.

Mary Butner, a former insurance specialist for CPS in Gallatin, Tenn., alleged that CPS charged some patients $1,500 for a drug test to measure blood levels of medication and $400 for a drug test designed to detect illegal drugs — charges that the suit called “grossly inflated and disproportional to the actual costs.” She also alleged that CPS would fill prescriptions for patients whose drug tests detected the presence of illegal drugs, or showed that they were not taking their medication as directed.

Butner also accused medical director Kroll of approving prescriptions for back braces when it was “clearly medically unnecessary,” including some people who had injuries to a knee or elbow.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

CDC: Opioid Guideline Should Not Be Used to Taper Patients

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By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has taken its first concrete step to address the widespread misuse and misapplication of its opioid prescribing guideline.

In a commentary published in The New England Journal of Medicine, the guideline’s authors say the agency does not support abrupt tapering or discontinuation of opioid medication, and that the guideline’s recommendation that daily doses be limited to no more than 90 MME (morphine milligram equivalent) should only be applied to patients who are starting opioid therapy.

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” wrote Deborah Dowell, MD, Tamara Haegerich, PhD, and Roger Chou, MD. “A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice.”

The co-authors also noted that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages,” nor does it seek to deny opioids to patients with cancer, sickle cell disease or recovering from surgical procedures.

The CDC’s clarification was cheered by patient advocates, who have been calling on the agency to address the suicides, patient abandonment and other unintended consequences of the guideline for over three years.

“The statement from the CDC is a long-awaited, robust clarification that has come at a critical time. They clearly defined that its Guideline cannot and should not be invoked to justify the forced reduction or denial of opioid pain medication to patients who use opioids to manage their long-term pain,” said Andrea Anderson, a patient advocate with the Alliance for the Treatment of Intractable Pain (ATIP).

The CDC’s controversial guideline was released in March 2016 as a voluntary set of recommendations meant to discourage primary care physicians from prescribing opioids for chronic non-cancer pain. But the guideline was quickly adopted by states, insurers, pharmacies, practitioners and even law enforcement agencies, who saw it as a mandatory policy that all physicians should follow to reduce rates of opioid addiction and overdose.

Reports soon began surfacing of patients being forcibly tapered off opioids or being abandoned by doctors who no longer wanted to treat them. Within months of the guideline’s release, CDC was warned by its own public relations consultants that “doctors are following these guidelines as strict law” and that some patients “are now left with little to no pain management.”

In PNN’s recent survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide because their pain is poorly treated. Many are hoarding opioids because they fear losing access to the drugs and some are turning to other substances – both legal and illegal – for pain relief.

‘Unintended Harms’

Not until this month did CDC acknowledge that its guideline was causing patient harm.

“CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms,” CDC Director Dr. Robert Redfield wrote in an April 10 letter to a group of healthcare professionals. who had asked the agency to make a “bold clarification” of the guideline.

Redfield’s letter was sent the day after the Food and Drug Administration warned doctors not to abruptly taper or discontinue opioids. The FDA said it had received reports of “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.    

“The clarification is an essential beginning because it is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia,” said Kate Nicholoson, a civil rights attorney and pain patient.  

“It is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia.”
— Kate Nicholson, Civil Rights Attorney

“Given the harms suffered by pain patients, a muscular, public-facing clarification from the CDC was needed. We hope that this action and the warning the FDA issued last week against abrupt tapering of pain patients will mark a beginning in protecting the rights of patients who use opioid medication appropriately to manage pain.” 

But other patient advocates wonder why it took so long for the CDC to act.

“It's gratifying to see CDC admit that its guideline is being misinterpreted and misapplied, as many of us have been warning for some time,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management. “It's a bit puzzling to me why it has taken them three years to do so, when many of us, myself included, told them within days of the guideline's issuance that these things were going to happen.

“Unfortunately, we've spent the past three years watching three dozen states violate CDC's stated intent that the guideline not be legislated, not to mention the untold numbers of insurance companies, health care systems, private practices, and pharmacy chains that have created a whole population of opioid refugees by misusing the guideline. Serious harms, including patient deaths, have resulted, and there is virtually no evidence that the intended effect of reducing prescription opioid overdose deaths has occurred, while overall opioid overdose deaths continue to climb rapidly.”

The New England Journal of Medicine is a respected publication with a wide reach among healthcare professionals, but it is not clear what CDC will do to caution states, insurers, pharmacies and law enforcement agencies about their misuse of the guideline.

“Unless Congress and the Executive Branch tell the DEA (and by association, state drug enforcement authorities and prosecutors) to stand down from persecuting doctors, I don't see any useful impact for this statement at all,” Richard “Red” Lawhern, PhD, of ATIP wrote in an email. “Doctors will continue to leave pain management and to desert their patients until they can be assured they will not be sanctioned, so long as they act in good faith to treat pain and manage their patients.” 

In recent months, federal prosecutors in Wisconsin and several other states sent letters to hundreds of physicians warning them that their opioid prescribing practices exceed those recommended by the CDC. The doctors were identified through data-mining of prescription drug monitoring programs (PDMPs), which have been weaponized to target physicians. 

“Practitioners were identified where they prescribed on average 90 MMEs (or more) per patient per day. That’s the threshold where the CDC and the Wisconsin Medical Examining Board say there is no real evidence to suggest that above that amount has any better effect on chronic pain,” a DOJ spokesperson told PNN.  

Just last week, a DEA task force charged dozens of doctors and other healthcare providers with illegal opioid prescribing. Prosecutors say more criminal cases are in the pipeline. 

"We have hyper-accurate data at the DEA and other agencies in the federal government where we are able to (use) that data and we can sort of pinpoint where these pills are being over-prescribed just by the population center in which they're being prescribed," said Jay Town, a federal prosecutor in Alabama.  "There are more doctors out there, there are more people working in clinics, and physicians’ offices, or pharmacies, or in compounding pharmacies, that we still have ongoing investigations or beginning investigations.” 

‘Achieve Widespread Adoption’ 

The CDC may have finally acknowledged the “unintended harms” caused by the guideline, but the data-mining and wholesale adoption of its recommendations are exactly what the agency outlined in a 2015 CDC memo obtained by PNN:   

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings. CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.  

Activities such as development of clinical decision support in electronic health records to assist providers’ treatment decisions at the point of care, identification of mechanisms that insurers and pharmacy benefit plan managers can use to promote safer prescribing within plans, and development of clinical quality improvement measures and initiatives to improve prescribing and patient care.”

Can the CDC undo all the harm its “user-friendly materials” have caused over the last three years? Will states be advised to rollback their laws and regulations? Will insurers and pharmacies be told to stop limiting the dose of opioid prescriptions? And what about the patients who committed suicide? The CDC did not respond to a request for comment.

“That no one at CDC anticipated that the guideline would be misinterpreted and misapplied in this way is hard to swallow,” said Twillman. “I would have hoped that they would be vigilant for such occurrences, and taken action swiftly and effectively when they became apparent.”

A Pained Life: Fearful Fortunes

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By Carol Levy, PNN Columnist

I love fortune cookies, but have no faith in the fortunes themselves. I opened a cookie recently and out came this message: “Listen to what you know instead of what you fear.”

I am going through a bad time recently. For 19 years I have had a spontaneous remission of the worst of my trigeminal neuralgia pain.

The trigeminal nerve now seems to be regenerating and it worries me. I get sporadic tingling sensations in the numbed areas of my face, the result of a procedure done in 1979. Within the last few months, the spontaneous pain has also started coming back, not in the same way, and only one or two flares were horrific.

I am very fearful all the pain will return.

My new neurologist specializes in headaches. My situation is an unknown to him. He is very nice but is essentially throwing drugs at me, a new one each time the one he just prescribed doesn't help or gives me terrible side effects. He is throwing things at the wall and hoping something will stick. I fear nothing will.

I finally found someone who specializes in trigeminal neuralgia and facial neuropathy, my disorders. She asked for a copy of my medical records so she can decide if she will accept me as a patient.  I fear she will refuse. Or if she agrees to see me will be unable to help — like almost all the others.

A woman I know has fibromyalgia and Complex Regional Pain Syndrome (CRPS). For years she has been on high dosages of Dilaudid and another strong opioid. Her doctor decided he would halve her dosages of both. She was appropriately fearful of being tapered. But to her astonishment she found she could tolerate the reductions. She is happily doing just as well on the lower dosages as she had been on the higher amounts.

A lot of what we go through is often based on fear. It is legitimate. We know what the pain is like, we know what the medications do, we know what we can and cannot do. A lot of our choices are fear based: It hurts when I do this, so therefore I will never do it again.

I am able to do so much more, feel so much better when I am on this particular medication and this particular dosage, so I will refuse any changes. I am used to this doctor/physical therapist/specialist being involved in my treatment, even though I am not always happy with them, so I will stay anyway.

It is hard to give up the fear. Pain is not like painting a room a new color and then deciding you don’t like it. You can always just repaint. But change what I am used to doing to deal with the pain? That is not so simple. My pain may increase and be even more unbearable, more daunting.

But what if I take the chance and find I am okay?

Our minds and bodies have been programmed to do all we can to avoid pain. Fear is one of the ways we deal with it. As a kid you touch a hot stove and feel the excruciating pain of a burn. You very quickly learn to fear a hot stove, the fear keeping you from hurting yourself in the same way again.

It is almost counter intuitive to heed the fortune: “Listen to what you know instead of what you fear.”

What we know is why we fear. Maybe, at least for us, the fortune should read: “'Listen to what you know, but take the chance of fear anyway.”

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.” Her blog “The Pained Life” can be found here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

New Safety Concerns for Osteoarthritis Drug

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By Pat Anson, PNN Editor

Disappointing results from a Phase 3 clinical study are raising new safety concerns about an experimental class of pain-relieving drugs once considered a promising alternative to opioids.

Pfizer and Eli Lilly say 6.3% of osteoarthritis patients taking a 5 mg dose of tanezumab experienced rapidly progressive osteoarthritis in their joints. There was significant improvement in their pain and physical function, but the patients’ overall assessment of their condition was no better than those treated with non-steroidal anti-inflammatory drugs (NSAIDs).

Patients taking a lower 2.5 mg dose of tanezumab did not have any significant improvement in their pain, quality of life or overall condition. And 3.2% experienced rapidly progressive osteoarthritis.

“We are analyzing these findings in the context of the recent Phase 3 results as we assess potential next steps for tanezumab,” Ken Verburg, Pfizer Global Product Development, said in a statement. “We plan to review the totality of data from our clinical development program for tanezumab with regulatory authorities.”

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

Tanezumab was considered so promising a therapy that it was given fast track designation from the FDA in 2017, a process that speeds up the development of new therapies to treat serious conditions.

Ironically, it was the FDA that slowed the development of NGF inhibitors in 2010 because of concerns that tanezumab made osteoarthritis worse in some patients. Most clinical studies of tanezumab did not resume until 2015.

The reappearance of the same safety issue and the marginal pain relief provided by tanezumab could be the last straw for the drug, according to one analyst.

“It is hard for us to imagine how these results could have been much worse. Pfizer indicated that they ‘plan to review the totality of data’ with regulatory authorities, which suggests to us that the co-sponsors will try to find a way to resurrect the program for some subset or sub-population of patients, but recognizes that this result puts the drug’s entire future in doubt,” SVB Leerink research analyst Geoffrey Porges said in a note to clients.

A clinical study of fasinumab, another NGF inhibitor being developed by Teva and  Regeneron Pharmaceuticals, was stopped by the FDA in 2016 after a patient showed signs of severe joint disease. Regeneron and Teva are continuing to study fasinumab in patients with chronic low back pain.

Pfizer and Eli Lilly are also studying tanezumab as a treatment for low back pain, and reported promising results from a Phase 3 trial in February. Rapidly progressive osteoarthritis was also reported in a small number of patients involved in that study.

What It’s Like to Be Forcibly Tapered Off Fentanyl

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By Emily Ullrich, Guest Columnist

Although I have been on this chronic intractable pain, illness and medical refugee train for nearly a decade, I’ve been lucky to have the love and support my husband, family and wonderful people around the world that I've met through this shared anguish. They lift me up and allow me to lift them, when I can.

Right now, I'm holding onto them in utter panic, because they’re all that I have left.

About four years ago, I met a palliative care doctor, who had taken the time to read my 3-page health history. I take that paperwork with me to every visit to the ER or new doctor, so they can fully understand the things that I have tried, what worked, and what made things worse. No doctor had ever looked at it, until she did.

She approached me with zero judgment, and 100% sympathy and empathy. She actually cared about what I'd been through. I broke down sobbing, because I could finally let my guard down. I told her how my husband had to take a day off from work every month to drive me five hours and three states away, to see the only doctor I could find who was willing to treat my complicated needs. She told me I could see her instead. That was a tremendous gift.

Last year I began to sense that there was growing pressure on her about prescribing high doses of opioids, so I asked if I should worry about her cutting my meds or passing me off to another doctor. She reassured me that she would do no such thing.

Then came my visit one month later. I knew something was awry, because there was a case worker present for my appointment. My suspicions were confirmed when I was told the dose of my fentanyl patch would be tapered significantly lower. I was thrown into a tailspin.

With my doctor’s help and willingness to prescribe the meds and dosages that I needed, I had been able to achieve about a 4/10 on the pain scale, daily. I was able to participate in life again and do things that I love, like cooking, getting dressed up to go on a date with my husband, and other things that healthy people take for granted.

I was furious and traumatized that I was going to have to give up living my life. I still am.

On my next visit to see my doctor, she dropped another bomb. She told me that I had to choose between anti-anxiety meds and pain meds. Ironically, she was the one who put me on a higher dose of Xanax to help me cope with anxiety and insomnia. I felt betrayed.

I would not wish the hell of abruptly and simultaneously tapering off fentanyl and Xanax on anyone.  Even when I had a higher dosage, I still had pain flares that were not properly controlled. But since the taper began, I now have them daily.

I want this to be very clear: Fentanyl is a necessary medicine for many people with high pain levels. I have tried every other extended release medication known and none even touched my pain.

Fentanyl has gotten a bad reputation and patients who take it live with heavy stigma because the media usually report on fentanyl overdoses without distinguishing between illicit fentanyl and properly prescribed legal fentanyl.  

I would like to make a plea to the media: Stop the ignorant reporting and do your due diligence. By not distinguishing between legal and illicit fentanyl, you are causing even more strife for those of us who need the relief that only fentanyl medication brings.

I have still not gotten a clear reason for my doctor's decision to force a taper on me. I fear if I prod too much, she will totally cut me off or advise me to see someone else. This is making the struggle even worse, because even though we still have a pleasant relationship, I'm hurt and confused about this. I suspect it is being forced upon her.

As I wrote this, I had to take breaks for hours, sometimes days, because my pain is escalating to such a level that anxiety and insomnia are ravaging my mind and body. I have been in withdrawal (which, by the way, does not mean I am addicted to my medication, it means I'm physically dependent on it) for about four months.

As my medicine has been tapered, my life has crumbled. I get about two hours of sleep every five days. At times I get uncontrollable head shaking, leg kicking, arm flailing and vocal ticks. My pain gets so bad that I develop a full-body rash and migraines that last for days.

I don't know what is real and what my brain has concocted. I hold nonsensical conversations, like my grandparents did when they developed dementia. It is embarrassing and terrifying.

One night, while counting down the minutes until I could take my next dose of meds, I passed out from pain and anxiety, which scared my husband so bad that he called 911.

I hope that insurers, pharmacies and especially government officials who are infringing on doctors' ability to treat their patients, might read this and see that forcing tapers on patients is dangerous. There have already been many suicides because of them.

A gap is growing between many doctors and their patients. We know this is not “What's best for us.” It is actually a twisted way to make more money off the sick and vulnerable, forcing us to replace a medicine that is effective and safe when used responsibly with drugs that are ineffective, expensive and dangerous.

Emily Ullrich lives with Complex Regional Pain Syndrome (CRPS), chronic pancreatitis, endometriosis,  interstitial cystitis, migraines, fibromyalgia, osteoarthritis, anxiety, insomnia, depression, and other chronic illnesses. She is also a writer, filmmaker, activist, advocate, philanthropist and comic. As she is able, Emily devotes her time and energy fighting for pain patients’ rights.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Social Support Key to Recovery from Suicidal Thoughts

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By Pat Anson, PNN Editor

Hardly a day goes by that I don’t get an email or a comment left on this website about suicide.

Recently a young military veteran named “Joe” reached out. Joe is depressed and unable to work because he has chronic back and leg pain

“The thing is, I’m just about to turn 28 and can’t fathom how I’m supposed to go on like this for another year or two let alone trying to live my life for the next 60-70 years,” Joe wrote. “I’m not going to do anything yet but I have been seriously looking into euthanasia. I haven’t been able to have a real conversation with anybody about it, not even one of my 5 therapists or my wife, because I already know their reactions.”

Joe said he felt very rational about his decision but was anxious to talk about it “without being thrown into a straightjacket.”

Joe’s instinctive urge to talk with someone could be the key to working through this difficult time in his life, according to a new study by researchers at the University of Toronto. They analyzed a survey of 635 Canadians with chronic pain who had seriously thought about suicide to find out what qualities made those thoughts go away. Suicide “ideation” disappeared in about two-thirds of them.

Having a social support network – someone to talk to – was the key.

“The biggest factor in recovery from suicidal thoughts was having a confidant, defined as having at least one close relationship that provide the person in chronic pain a sense of emotional security and well-being,” said lead author Esme Fuller-Thomson, PhD, a Professor of Social Work, Medicine and Nursing and Director of the Institute for Life Course & Aging.

“Even when a wide range of other characteristics such as age, gender and mental health history were taken into account, those with a confidant had 87 percent higher odds of being in remission from suicidal thoughts compared to those with no close relationships."

People with pain who stopped having suicidal thoughts were also significantly more likely to be older, female, white, better educated, and more likely to use prayer and spirituality to cope with daily problems.

Living in poverty and struggling to pay basic living expenses were barriers to recovery from suicide ideation. Poverty can severely limit access to healthcare, transportation and social activity.

"Clearly we need targeted efforts to decrease social isolation and loneliness among those experiencing chronic pain. These participants reported that pain prevented some or most of their activities, so they were particularly vulnerable to social isolation,” said Fuller-Thomson. “More awareness by the general public that mobility limitations associated with chronic pain can make it difficult for individuals to socialize outside the household, could encourage friends and family to visit and phone more and thereby decrease loneliness."

PNN’s recent survey of over 6,000 patients and healthcare providers shows how pervasive suicide is in the pain community. Nearly half the patients said they have considered suicide, while nearly one in four practitioners said they have lost a patient to suicide.

The good news is that public health agencies are finally starting to pay attention to these issues. Last week the U.S. Food and Drug Administration warned doctors not to abruptly discontinue or rapidly taper patients on opioid pain medication because of the risk of suicide.

“(FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide,” the agency said.

If you or a loved one are having suicidal thoughts, support is just a phone call away. The Suicide Prevention Lifeline has trained counselors on duty 24/7 at 1-800-273-TALK.

Fentanyl May Be Classified as Weapon of Mass Destruction

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By Pat Anson, PNN Editor

The Trump Administration is considering labeling fentanyl as a weapon of mass destruction, according to an internal Homeland Security memo obtained by the military news website Task & Purpose.

"Fentanyl's high toxicity and increasing availability are attractive to threat actors seeking nonconventional materials for a chemical weapons attack," wrote James McDonnell, a DHS assistant secretary, in a February 22, 2019 memo to then-DHS Secretary Kirstjen Nielsen.

According to the memo, the FBI considers fentanyl “a viable option for a chemical weapon attack by extremists or criminals.”  The idea of labeling fentanyl a weapon of mass destruction (WMD) is also under consideration by the Department of Defense.

“Within the past couple years, there has been reinvigorated interest in addressing fentanyl and its analogues as WMD materials due to the ongoing opioid crisis,” McDonnell wrote.

DEA IMAGE

Fentanyl is a synthetic opioid, 50 to 100 more potent than morphine, that is legally prescribed to treat severe chronic pain. In recent years, bootleg versions of fentanyl and its chemical cousins have flooded the black market, where they are often added to heroin and cocaine to boost their potency or used in the manufacture of counterfeit medication.

According to the CDC, fentanyl is involved in more overdoses than another drug and was linked to 18,835 drug deaths in 2016.

Most of the black market fentanyl is produced by drug labs in China and then smuggled into the U.S. from Mexico or shipped through the mail.  

Designating fentanyl as a WMD would enable Homeland Security to increase funding for sensors and other technology that can detect fentanyl being smuggled in vehicles, packages and shipping containers.

A WMD expert told Task & Purpose the idea of fentanyl being used as a weapon was a “fringe scenario” because there are dozens of toxic chemicals that can be easily weaponized.

"It reads like somebody is laying the administrative background for trying to tap into pots of money for detecting WMD and decontaminating WMD," said Dan Kaszeta. "It's an interdepartmental play for money, that's all it is."

An unnamed senior defense official quoted by Task & Purpose was also skeptical.

"Anybody with a college level degree in chemistry can manufacture chemical weapons agents," the defense official said. “I cannot see any scenario where a nation-state would use fentanyl on the battlefield, or for that matter, a terrorist using a really toxic chemical like fentanyl in an attack when they could just sell it for funding the purchase of firearms and explosives or steal an industrial chemical instead.”

China recently agreed to ban all “fentanyl-related substances” by listing them as controlled substances. The move is meant to close a loophole that allowed drug labs to make novel variations of fentanyl that are not technically illegal.

Fentanyl Myths

While fentanyl is a scourge on the black market, drug experts say it’s not nearly as hazardous as it is often portrayed. Reports of first responders becoming severely ill after skin contact with fentanyl are likely the result of panic attacks.

“One of the issues with this dramatization of fentanyl toxicity is that it further stigmatizes substance users as contagious and dangerous. That can potentially delay care to those who need prompt rescue and treatment,” emergency medicine physicians Lewis Nelson, MD, and Jeanmarie Perrrone, MD, wrote in STAT News.

“There is no documented evidence of responders becoming ill after skin contact with fentanyl.”
— Health Canada

“There is clear evidence that passive exposure to fentanyl does not result in clinical toxicity. Descriptions of the signs and symptoms of those who have supposedly experienced passive toxicity vary widely. They include dizziness, blurry vision, pallor, weakness, sweatiness, high blood pressure, chest pain, heart palpitations, anxiety, and occasionally seizure-like activity. These findings are usually transient and resolve on their own, often far faster than would be expected, and are incompatible with the known duration of the drug’s effect.”

A fact sheet released by Health Canada also dispels some of the myths about fentanyl, telling first responders that skin exposure is “extremely unlikely to immediately harm you” and “there is no documented evidence of responders becoming ill after skin contact with fentanyl.”

Fentanyl has been used in at least one terrorist incident —- by law enforcement. In 2002, Russian police pumped an aerosol version of fentanyl into a Moscow theater where terrorists were holding hundreds of hostages. The gas inadvertently killed 117 of the hostages.

60 Arrested in Latest Crackdown on Rx Opioids

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By Pat Anson, PNN Editor

Sixty people in five states face charges of illegal opioid prescribing and healthcare fraud in the latest federal crackdown on opioids. The arrests are the first since the Justice Department established an opioid strike force last year to concentrate on drug crimes in the Appalachian region.

The defendents include 31 doctors, 7 pharmacists, 8 nurse practitioners and 7 other licensed medical professionals.

“The opioid epidemic is the deadliest drug crisis in American history, and Appalachia has suffered the consequences more than perhaps any other region,” Attorney General William Barr said in a statement. 

“But the Department of Justice is doing its part to help end this crisis. One of the Department's most promising new initiatives is the Criminal Division's Appalachian Regional Prescription Opioid Strike Force, which began its work in December.  Just four months later, this team of federal agents and 14 prosecutors has charged 60 defendants for alleged crimes related to millions of prescription opioids.” 

The charges involve over 350,000 opioid prescriptions and over 32 million pills. A federal prosecutor claimed that was the equivalent of a dose of opioids for every man, woman and child in Ohio, Kentucky, Tennessee, West Virginia and Alabama.

In one case, a doctor and several pharmacists are accused of operating a pill mill in Dayton, Ohio. Over a two-year period, the pharmacy dispensed over 1.75 million pills. 

In Kentucky, a doctor operating a pain management clinic allegedly provided pre-signed, blank prescriptions to office staff who then used them to prescribe controlled substances when he was out of the office. 

And in Tennessee, a doctor who called himself the “Rock Doc” allegedly prescribed dangerous combinations of opioids and benzodiazepines, sometimes in exchange for sexual favors.

“Reducing the illicit supply of opioids is a crucial element of President Trump’s plan to end this public health crisis,” Health and Human Services Secretary Alex Azar said in a statement.  “It is also vital that Americans struggling with addiction have access to treatment and that patients who need pain treatment do not see their care disrupted, which is why federal and local public health authorities have coordinated to ensure these needs are met in the wake of this enforcement operation.”

A DOJ press release provided a list of hotlines, websites and other resources where effected patients can get addiction treatment. None of them, however, appear to offer pain management.

Pain patients are often the forgotten victims in law enforcement crackdowns on healthcare providers. Dawn Anderson, for example, a double amputee and diabetic, died last month in “sheer agony” because she was no longer able to get opioid medication from a pain management doctor who stopped practicing medicine after he was accused and convicted of healthcare fraud.    

Most Overdoses Don’t Involve Rx Opioids

The Appalachian region – and West Virginia in particular – has been ground zero in the opioid crisis. But a new study by researchers at West Virginia University shows just how much the crisis has shifted away from prescription opioids.

Researchers analyzed over 8,800 drug-related deaths in West Virginia from 2005 to 2017 and found that deaths involving fentanyl soared by 1,325% over that period.

From 2005 to 2014, prescription opioids were involved in almost 60% of drug related deaths in West Virginia, but from 2015 to 2017 they were only involved in about 30% of drug deaths.

West Virginians are now twice as likely to die from fentanyl than they are from oxycodone. Deaths linked to fentanyl, heroin, alcohol, alprazolam (Xanax) and cocaine outnumber those from oxycodone or any other opioid pain reliever.

Fentanyl and its analogs are synthetic opioids 50-100 stronger than morphine. They’ve become a scourge on the black market, where they are frequently mixed with heroin and cocaine to boost their potency or used in the manufacture of counterfeit medication.

Reducing the supply of prescription opioids and locking up doctors isn’t going to solve the fentanyl problem.

"One of the proven ways to reduce overdoses is to decrease the number of people who are addicted and using. But with fentanyl, you could halve the number of addicts in West Virginia, and the overdose rate could still go up because the strength of the drug coming in is so much stronger and can vary widely from one day to the next," said Gordon Smith, MD, an epidemiologist in the West Virginia School of Public Health. "This is an absolute quandary."

West Virginia's increase in fentanyl-related deaths is part of a national trend. As the CDC reported, deaths from fentanyl overdoses spiked across the United States in 2015 and are still climbing. West Virginia leads the nation in fentanyl-related deaths and has the highest per capita rate of overdose deaths overall.

When Will Forced Tapering of Opioids End?

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By Lynn Webster, MD, PNN Columnist

“Larry” recently wrote to me asking for advice. He describes himself as "virtually crippled totally" after having his opioid medication cutback.

"I am being forced tapered and the PA I now have will not budge one inch on the weaning, as he calls it. I hate him. I have never had a more callous doctor in my life," Larry wrote.

"What does one do in my situation? Blow my brains out? A[n] intentional overdose? I have two beautiful dogs that depend on me and a son who needs me. I have to stay here on planet Earth although I want out of here so bad I beg God to kill me every morning noon and night. It is my daily prayer."

Unfortunately, Larry is only one of many patients who are struggling to be heard by their providers. Physicians are under government pressure to adhere to the CDC’s 2016 opioid prescribing guideline.

Although the CDC designed its guideline as voluntary, government agencies interpreted it as a mandate instead. The Drug Enforcement Administration has pursued doctors who prescribe a level of opioids that exceeds the guideline's recommended daily limit of 90 MME (morphine milligram equivalent), even when no patients have been harmed.

According to Maia Szalavitz, writing for Tonic, Dr. Forest Tennant was one of the few physicians who still were willing to prescribe high-dose opioids for the sickest pain patients. The DEA raided his California office and home, allegedly because the agency had reason to believe some of his patients were selling their medication.

There simply was no evidence of that. But as a result of the raid, Dr. Tennant retired from clinical practice.

Szalavitz wrote that the raid "terrifies pain patients and their physicians, who fear that it could lead to de facto prohibition of opioid prescribing for chronic pain and even hamper end-of-life care."

Dr. Mark Ibsen in Montana had his license suspended by the state medical board for allegedly overprescribing opioids. According to Dr. Ibsen, the DEA warned him "he was risking his livelihood and could end up in jail if he kept prescribing." A judge later overturned the board’s decision.

As Dr. James Patrick Murphy, a Kentucky-based pain and addiction specialist, told the Courier-Journal, "many well-intended doctors are unfairly arrested 'all the time' in the hunt for those who recklessly contribute to patients' addictions and fatal overdoses."

As of this writing, The American University Law Journal plans to publish an alarming article by Michael Barnes, JD, about the raids on America’s top physicians.

Although few physicians are incarcerated for prescribing high dosages of opioids, many of them are threatened with losing their licenses to practice medicine. Doctors and pharmacists told a POLITICO survey that they felt enormous pressure to limit their prescriptions for painkillers. Their fear of the consequences of noncompliance with the CDC guideline exceeded their responsibility to treat patients with severe pain.

Second Thoughts About CDC Guideline

On April 1, the attorneys general of 39 states and territories wrote a letter on behalf of the National Association of Attorneys General to Dr. Vanila Singh of the U.S. Department of Health and Human Services. The letter expressed concern with the draft report of the Pain Management Best Practices Inter-Agency Task Force, which recommends changes in the CDC guideline to end the forced tapering of patients.

The attorneys general said "it is incomprehensible that officials would consider moving away from key components of the CDC guideline." Additionally, they expressed their hope that the report would be revised "to clearly state that there is no completely safe opioid dose."

Yet on April 9, the Food and Drug Administration issued a medical alert warning doctors not to abruptly discontinue or rapidly taper patients on opioid medication, because it was causing “serious harm” to patients, including uncontrolled pain, psychological distress and suicides.

Now it seems the CDC may be moving in the same direction.

Dr. Daniel Alford, a Professor of Medicine at Boston University, wrote a letter to the CDC asking it to address the misapplication of its guideline with a "public clarification." He was writing on behalf of Health Professionals for Patients in Pain, and 300 healthcare professionals signed his letter.

The CDC's response, published on April 10, echoed the FDA's statement. CDC Director Dr. Robert Redfield observed that the CDC guideline "offered no support for mandatory opioid dose reductions in patients with long-term pain." He reinforced the fact that the guideline was voluntary and that doctors should use their knowledge of their patients to determine which dosages were appropriate for them.

Dr. Redfield wrote that “CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms." And he agreed that "patients suffering from chronic pain deserve safe and effective pain management."

STAT News points out that the overzealous enforcement of the CDC guideline was indeed causing patients harm. "Denying opioids to patients who have relied on them — sometimes for years — may cause some to turn to street drugs, thereby increasing their risk of overdose," STAT warned.

According to The Washington Post, "Many patients have claimed that long-term use of the drugs is all that stands between them and unrelenting pain, and that they can take the medication without becoming dependent or addicted."

The CDC and the FDA now admit the guideline has been misapplied and mainstream media outlets are beginning to pick up the story. The question is: Will the DEA stop pursuing doctors who treat pain patients with levels of opioids that exceed the guideline's recommendations?

For Larry and other pain patients who have been forcibly tapered, the answer may be a matter of life and death.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

CVS Fined $535,000 for Filling Forged Opioid Prescriptions

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By Pat Anson, PNN Editor

CVS Pharmacy has agreed to pay a $535,000 fine to resolve allegations that several of its Rhode Island stores filled dozens of forged prescriptions for Percocet, a potent opioid painkiller. It’s the latest in a series of fines the nation’s largest pharmacy chain has paid for violations of the Controlled Substances Act.

According to DEA investigators, CVS pharmacists filled 39 forged prescriptions for Percocet between 2015 and 2017 even though they “knew or had reason to know that the prescription in question was invalid or unauthorized.”

In a settlement agreement with the Department of Justice, CVS agreed to pay the fine while making no admission of any liability or wrongdoing. The company said it wanted to avoid the expense and uncertainty of going to trial. In return, the DOJ agreed to drop all civil or criminal prosecution of the case.

“DEA registrants like CVS have a corresponding responsibility to dispense controlled substances in accordance with the Controlled Substance Act,” said DEA Special Agent in Charge Brian Boyle. 

“Pharmacies put patients at risk when they dispense Schedule II narcotics, which have the highest potential for abuse, without a valid and legal prescription.  Today’s settlement demonstrates DEA’s commitment to work with our law enforcement and regulatory partners to ensure that these rules and regulations are followed.”

It’s not the first time CVS has been accused of lax or fraudulent behavior involving opioid medication.

In 2017, CVS agreed to pay a $5 million fine to settle allegations that several of its pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone.

In 2016, CVS agreed to pay a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged prescriptions for opioids. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight different CVS stores.

And in 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

All of these cases were settled out of court.

In 2018, CVS angered pain patients when it began to limit the initial dose of opioids to 7 days’ supply for customers enrolled in CVS Caremark health plans. For both acute and chronic pain patients, CVS said daily doses of opioids should not exceed 90 MME (morphine milligram equivalent) and patients would be required to use immediate release formulations. CVS said it was making the CDC opioid guideline the “default approach” to prescribing opioids.

Last week, CDC Director Dr. Robert Redfield acknowledged for the first time the agency’s voluntary guideline was causing “unintended harms” and that patients should only be tapered to lower doses “if a patient would like to taper.”  

“The Guideline does not endorse mandated or abrupt dose reduction or discontinuation, as these actions can result in patient harm,” Redfield said. “The Guideline includes recommendations for clinicians to work with patients to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy.”

Nothing in the guideline empowers pharmacists to set dose limitations. CVS operates 9,700 pharmacies and 1,100 walk-in medical clinics nationwide

Stem Cells Reduce Pain from Knee Osteoarthritis

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By Pat Anson, PNN Editor

A small new study has demonstrated that stem cells collected from a patient’s own bone marrow can significantly reduce pain caused by osteoarthritis of the knee.

In the first clinical trial of its kind in Canada, researchers collected mesenchymal stromal cells (MSCs) from the spines of 12 middle-aged patients with moderate to severe knee osteoarthritis. These “autologous” cells – stem cells derived from a patient’s own fat or bone tissue – were then processed and injected back into the patients’ knees at different doses.

Researchers then followed the patients for the next 12 months, using MRI imaging, biomarkers, molecular fingerprinting and the patient's own assessment of how they felt.

"Our goal was to test for safety as well as to gain a better understanding of MSC dosing, mechanisms of action and donor selection," said lead author Sowmya Viswanathan, PhD, Arthritis Program at the Krembil Research Institute, University Health Network in Toronto.

At the end of the study period, researchers said there were significant improvements in all 12 patients’ pain levels, stiffness and quality of life. The study also showed that the MSCs were safe at all the doses tested and that the higher the dose, the more effective the outcome.

"We also obtained novel insights into a potential anti-inflammatory mechanism of action of these cells in osteoarthritic knee joints. We noted that donor heterogeneity is an important factor, and our assembled panel of genes helps us identify cells which are potent in osteoarthritis. These are important findings which we hope to translate into a larger, powered clinical trial as part of our next steps," said Viswanathan, who reported the findings in the journal Stem Cells Translational Medicine.

Over 250 million people worldwide suffer from knee osteoarthritis (OA), which causes thinning of cartilage and progressive joint damage. Nearly 40 percent of Americans over the age of 45 have some degree of knee OA.

Knee replacement and arthroscopic knee surgeries are commonly used to treat knee OA, even though many studies show they have limited effectiveness. A 2017 study in The British Medical Journal  of over 7,400 patients who had knee replacement surgery found the procedure often had minimal effects on quality of life and wasn’t worth the cost.

Arthroscopic surgery is less invasive than a total knee replacement, but studies also show it is often not effective. In 2017, an international panel of experts reviewed 25 studies involving nearly two million patients and concluded that arthroscopic surgery does not improve long term pain or function in patients with knee conditions such as osteoarthritis.

Because these conventional treatments often fail, there is growing interest in the use of stem cells to treat knee problems. The FDA, however, takes a dim view of autologous stem cells and released guidance in 2017 that requires the cells to undergo “minimal manipulation.”

The FDA recently sent letters to 20 stem cell manufacturers and clinics warning them they were violating FDA regulations. The agency says the science behind autologous cells is still in its early stages and they have not been proven to be safe and effective.

“There’s a false premise being asserted by some in the field that a product derived from a person’s own body and then manipulated and reinserted for another use different from the one it played in its original location is not subject to FDA regulation just because it originated from the person it was given back to,” then FDA commissioner Scott Gottlieb, MD, and Biologics Center Director Peter Marks, MD, said in a statement.

“We’ve seen too many cases of sponsors claiming that cells aren’t subject to FDA regulation just because the cells originated from the same patient to whom the eventual manufactured product is being given. And we’ve seen too many cases of companies making unsubstantiated claims that these treatments prevent, treat, cure or mitigate disease where the products have sometimes led to serious patient harm.”

Using Cannabis and Opioids Together May Not Be Such a Great Idea

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By Roger Chriss, PNN Columnist

The opioid-sparing effect of cannabis is routinely touted as a reason for marijuana legalization. The hope is that cannabis combined with opioid medication will produce equal analgesia at lower opioid doses, thus reducing the risks associated with opioid therapy.

But evidence in favor of the opioid-sparing effect is largely pre-clinical and often involves animals or healthy volunteers, not the real world conditions that pain patients live with.

A recent study on rhesus monkeys, for example, at the University of Texas found that combining cannabinoids with morphine did not significantly increase the impulsivity or memory impairment of the monkeys.

A 2018 study by Ziva Cooper and colleagues on healthy cannabis smokers concluded that cannabis enhances the analgesic effect of oxycodone, suggesting there is a synergy between the two.

And a 2017 systematic review of over two dozen studies in the journal Neuropsychopharmacology reported “robust evidence of the opioid-sparing effect of cannabinoids.”

But evidence against the opioid-sparing effect of cannabis is mounting, based on clinical findings in real-world chronic pain patients.

Andrew Rogers of the University of Houston reported at the 2019 American Pain Society Scientific Meeting that chronic pain patients who used both prescription opioids and recreational marijuana showed higher levels of anxiety, depression and substance abuse problems than those who used opioids alone. There was no difference between the two groups in pain levels.

"The things psychologists would be most worried about were worse, but the thing patients were using the cannabis to hopefully help with — namely pain — was no different,” Rogers told MedPageToday. "Co-use of substances generally leads to worse outcomes. As you pour on more substances to regulate anxiety and depression, symptoms can go up."

A large Australian study in The Lancet Public Health found that cannabis use was common in patients with chronic non-cancer pain who were prescribed opioids, but “there was no evidence that cannabis use reduced pain severity or interference or exerted an opioid-sparing effect.”

This research, known as the Australia POINT study, followed over 1,500 chronic pain patients for almost four years. Although its methodology has limitations, it is one of the largest long-term studies of opioids and cannabis under real-world conditions.

“At each assessment, participants who were using cannabis reported greater pain and anxiety, were coping less well with their pain, and reported that pain was interfering more in their life, compared to those not using cannabis,” said lead author Gabrielle Campbell, PhD, of the University of New South Wales.

In other words, the opioid-sparing effect of cannabis seems not to work well in the real world, despite its apparent success under laboratory conditions. There are several possible factors at work.

First, laboratory conditions are artificial. Studies often use lab animals or healthy human volunteers. But people with chronic health conditions may be different. Or perhaps people who are experienced with cannabis and willing to spend a day in a laboratory being subjected to painful stimuli are different.

Second, laboratory studies are often short term, but chronic pain is long term. The cumulative risks of opioids and cannabis, as well as the complex interactions between them, may take time to unfold and discover. It is possible that an initial opioid-sparing benefit washes away quickly and is replaced by nontrivial risks.

Third, real-world studies emphasize patient outcomes, a factor that laboratory work cannot assess. Because outcomes are so important, studies that focus on them must be given greater weight. 

More research will be needed to sort out the effects of combining cannabis and opioids in chronic pain management. But at present, clinical studies point to more risks and harms than benefits. Perhaps a subset of patients or a particular combination of a specific opioid and cannabis preparation will change this. Or perhaps combining cannabis and opioids is not such a great idea. 

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.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

You're as Healthy as the Food You Eat

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By Barby Ingle, PNN Columnist  

It’s important that patients with chronic pain conditions maintain a healthy lifestyle, including getting enough sleep, exercising and eating healthy foods. I know this is so much easier said than done.

You are what you eat, right? We hear this often growing up, but what does it really mean? If I have a cupcake or a slice of cheesecake, am I going to live through the night? Over course I am. But day after day of poor eating will have long-term health consequences. And when our health is poor, other aspects of life are also likely to suffer.

Patients with chronic pain and illness typically lead a more sedentary lifestyle. Because we are less active and burn off fewer calories, we are at greater risk for developing other medical problems such as cardiovascular disease, diabetes and osteoporosis. I myself have been dealing with poor posture and sudden weight gain and loss. I fall easily and have trouble gripping and holding onto things. 

One area we have more control over is what we eat and who we are eating with. When I’m at home, my spouse cooks meals for me. I used to just let him choose what he wanted to make because I was just happy to have a meal prepared for me.

I have been really working on my eating habits since being diagnosed as "skinny fat" last year. I had to change where I am eating, how I am eating and what I am eating. Although my husband doesn’t eat the same food as me most of the time, my healthier habits have rubbed off on him.

I make a grocery list for what I want to eat, instead of just eating what he prepares for himself. I also now eat about 6 times a day instead of 3 bigger meals and a snack. 

Hopefully those around you are supportive of you making changes in your diet. When they see you make a conscious effort to choose your own meal and set your own portion limits, they may be empowered to pay attention to their own habits. You don’t have to say “no” to everything, just keep indulgences under control, eat smaller portions and be mindful of what you are eating.  

As a former athlete, I know nutrition is crucial for good performance outcomes. But when I got sick, I let all of that go. I had more important challenges to focus on, or so I thought.

Nutrition plays a role in chronic pain and how we prepare our bodies to cope with the stress.  Make sure your doctor is doing frequent blood testing to check for any deficiencies you may develop. A friend of mine developed Hypokalemia, a potassium deficiency that led to a psychological breakdown and two mental hospital stays.

Medications can also affect your liver, kidneys and digestive system. Blood testing can help prevent this from getting out of control and let you know if dietary supplements are needed to counter poor vitamin absorption.  

Maintaining good nutrition and hygiene may be difficult, but are very important. My new reality is that I am disabled and need to ask for help. I have to pay attention to what I eat, my hormones, my vitamins and everything I put on and in my body.

Eating is an important part of our lives and healing is a process. I have to control the parts of my life that I can to be able to live the life that I want.  

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.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Biden: ‘A Little Pain Is Not Bad’

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By Pat Anson, PNN Editor

Former Vice-President Joe Biden, who appears close to announcing a run for president in 2020, may want to think twice about the message he’s sending to a large group of voters: chronic pain patients.

While speaking Thursday as part of a panel on the opioid crisis at the University of Pennsylvania, Biden said too many doctors “willy-nilly overprescribed” opioid pain relievers.

"A little pain is not bad," said Biden. “A lot of people can get addicted within five days.”

FORMER VICE-PRESIDENT JOE BIDEN

“We got here, I believe in part, because of the greed of the drug companies and the irresponsibility of them and, quite frankly, a lack of sufficient responsibility on the part of the medical profession,“ Biden said, adding that 215 million prescriptions for opioids were written in 2016.

“We desperately need people with chronic pain to have this access, but you cannot convince me anywhere near that is the case,” he said.

The 76-year old former senator also expressed regret about being a co-sponsor of the 1988 Anti-Drug Abuse Act, which created tougher sentencing guidelines for crack cocaine. Critics say the law sent a disproportionate share of African-Americans and other minorities to prison.

"The big mistake was us buying into the idea that crack cocaine was different from the powder cocaine, and having penalties ... it should be eliminated," Biden said, according to Delaware Online. “I’m sorry I didn’t know more about behavior.”

Biden’s knowledge about the opioid crisis appears dated. The vast majority of overdose deaths are now attributed to illicit fentanyl, heroin and other black market opioids, not pain medication. The number of opioid prescriptions has also been declining for several years and now stand at their lowest level since 2003.

Prescription opioids are not particularly risky if used responsibly, according to a recent study of over half a million Medicare patients who were prescribed the drugs. Over 90 percent had a negligible risk of an overdose. Even among “high risk” patients on high opioid doses, the risk of an overdose is less than two percent.  

A major review of studies on long term opioid therapy found that only 0.27% of patients were at risk of opioid addiction, abuse or other serious side effects. In another large study, The British Medical Journal reported that only 3% of opioid naïve patients (new to opioids) continued to use the drugs 90 days after a major elective surgery.

Biden’s advice to pain sufferers that “a little pain is not bad,” is reminiscent of a statement by former Attorney General Jeff Sessions, who told a Florida audience in 2018 that "people need to take some aspirin sometimes and tough it out.”

You can watch the opioid panel discussion on YouTube by clicking here.