WHO Criticized for Withdrawing Opioid Guidelines

By Pat Anson, PNN Editor

A coalition of international palliative care organizations is protesting a decision by the World Health Organization (WHO) to withdraw two guidelines for treating pain with opioid pain medication.

“We are extremely concerned that the withdrawal of these guidance documents will lead to confusion and possible extreme measures that will hinder access to patients with legitimate medical needs,” the coalition said in a joint statement released this week.

The guidelines were withdrawn after two U.S. congressmen released a report that accused WHO of being “corruptly influenced” by Purdue Pharma and other opioid manufactures when it developed the guidelines in 2011 and 2012. The guidelines for treating pain in adults and children state that opioids “are known to be safe and there is no need to fear accidental death or dependence.”

Reps. Katherine Clark (D-MA) and Hal Rogers (R-KY) said the WHO guidelines served as “marketing materials” for Purdue, the maker of OxyContin.

“We are highly troubled that, after igniting the opioid epidemic that cost the United States 50,000 lives in 2017 alone… Purdue is deliberately using the same playbook on an international scale,” the report said. “If the recommendations in these WHO guidelines are followed, there is significant risk of sparking a worldwide public health crisis.”

WHO withdrew the guidelines a month after the report was released, citing “new scientific evidence” that emerged since their publication.

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WHO’s decision to withdraw the guidelines gave credibility to a congressional report based largely on innuendo, according to the statement released by over a hundred palliative care organizations, including the American Academy of Hospice and Palliative Medicine and the UK-based International Observatory on End of Life Care.

“The report contains serious factual inaccuracies and draws inaccurate and unfair conclusions. It includes misleading information, and by making false accusations of existing collaborations and alliances to advance pain relief and palliative care, concludes that there was corruption within WHO,” the coalition said. “No staff member of the offices of the U.S. representatives contacted any of the organizations or individuals mentioned in the document to seek our responses to the allegations made in the report.”

According to the coalition, the withdrawal of the guidelines could further impede the availability of pain medication in third world countries, where less than 2% of palliative care patients have access to opioids.

“Under-treatment of severe pain is reported in more than 150 countries,” the coalition said. “At least 5 billion people live in countries affected by the crisis of under-consumption, and more than 18 million annually die with untreated, excruciating pain.”

The coalition cited the case of a cancer patient in New Delhi, India, who wanted to die until she was able to obtain opioids through a CanSupport palliative care program.  

I am a functioning human being in charge of my life once again. This has been made possible thanks to the oral morphine that I now take.
— Cancer patient in New Delhi, India

“I was a human wreck. My family was at their wits end as to how to help me. Because of my excruciating pain, I could not sit, sleep, eat or drink, let alone speak or think. When the team first met me my first request to them was for an injection that would put me out of my misery,” the patient said.

“Today, I am a functioning human being in charge of my life once again. This has been made possible thanks to the oral morphine that I now take on a regular basis.”

The palliative care coalition said it was unfair to deny opioids to patients in third world countries because of abuse and addiction problems in the U.S. and other developed nations.  The coalition called on WHO to update and revise the guidelines “with all deliberate speed” and to reinstate them until the revisions are made.

Is Palliative Care an Option for Chronic Pain Patients?

By Rochelle Odell, PNN Columnist

Most of us have heard about 2016 CDC Opioid Guideline, which is supposed to be a voluntary guideline for primary care physicians treating non-cancer pain.

What has happened? In the span of two years the guideline has seemingly become law. Countless pain patients have made the trek to their doctor dreading the thought that their lifeline -- opioid pain medication – will be reduced or even discontinued.

Pain patients are often forced into surgical procedures such as epidural steroid injections or implants of spinal cord stimulators and other medical devices. The implants and injections all too often create more problems than they help. I know because I have had three different stimulators implanted and removed, as well as two pain pumps. The devices ultimately damaged my spine, compounding my Complex Regional Pain Syndrome (CRPS). 

Many of us are told if we do not undergo these invasive procedures our opioid medication will be stopped.  We are then forced to find a new physician for pain medication, a search that is often futile.

What happened to “patient driven healthcare” and freedom of choice in the so-called opioid epidemic? Is there anything patients can do?

Yes, we can request our physician determine if we meet the requirements for palliative care, which is specifically exempt from the CDC guideline.

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Palliative care is often confused with end-of-life or hospice care, but imminent death is not a requirement for palliative care. The CDC defines palliative care in a way that many chronic and intractable pain patients would qualify for:

“Palliative care is defined… as care that provides relief from pain and other symptoms, supports quality of life, and is focused on patients with serious advanced illness. Palliative care can begin early in the course of treatment for any serious illness that requires excellent management of pain or other distressing symptoms for cancer.”

The World Health Organization (WHO) takes a similar broad view of palliative care:

“Palliative care is an approach that improves the quality of life of patients and their families facing the problem associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual.”

According to WHO, palliative care should include “a support system to help patients live as actively as possible” and “enhances quality of life.”

If these palliative care conditions are met, does it mean we are safe from having our opioid medication cutoff? Not necessarily. but it’s an option we should ask our doctors about.

Therein lies a possible roadblock. Too many physicians, nurses and healthcare organizations still associate palliative care with cancer and other diseases where the only outcome is death. 

The Alliance for the Treatment of Intractable Pain (ATIP) is working to enhance and clarify the definition of palliative care to include those suffering from chronic, intractable pain that may not be terminal. Cancer pain isn't necessarily different or anymore painful than the pain suffered by CRPS patients. Our pain is often worse, as there is no end in sight. The pain lasts a whole lifetime and we do not get better.

A case in point regarding the confusion over palliative care. A friend of mine was told that she qualified for palliative care. Great, one might think.  Her pain medication is still being prescribed, but her physician is afraid of losing his license and will not continue to prescribe her current dose or increase it. She will have to find a new pain management physician, assuming she can find one. 

I have been requesting for over two months that I be evaluated for palliative care, but my own pain management group "does not do palliative care." My case manager told me palliative care is only meant to keep the patient out the hospital.

My primary care physician's office has been working on my request and recently a doctor from Home Health Care came to my home to evaluate me. Not for palliative care, but for Transitional Care Management (TCM), a term I had not heard of. 

TCM is very much like palliative care in that the patient receives care from any needed medical specialty. A support system is put in place and whatever specialist I need to see will be covered.  The physician who did the evaluation based it not only on my medical records but by interviewing me and going over all my physical and mental health requirements. He noted I had been on high dose opioids and anti-anxiety medication and functioned with both them. He also recommended that my opioid medications be increased.

Will they be increased? I don't know yet, but a Home Health Care nurse will now be coming to my home on a regular basis. Unless I am unconscious and basically on death's door, I will not go to an emergency room for treatment. I refuse to wait hours on end only to be treated like a drug seeker. The nurse will come to my home and give me opioid medication if I need it. That is a definite plus and something I will not abuse.

These two avenues of palliative care and transitional care management appear to be a chronic pain patient's only options. Many doctors may not initiate either one. It is often the patient or patient's family who must push for care. Being alone and with no help means I will have to do more research and seek care even if it means contacting my physician's office multiple times. It’s the only option I have.

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Rochelle Odell resides in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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.

‘Opiophobia’ Leaves Millions Dying in Chronic Pain

By Pat Anson, Editor

More than 25 million people – most of them poor and living in developing countries – die each year in severe pain because they have little or no access to morphine and other painkillers, according to a new report.

A special commission created by The Lancet medical journal looked at pain care around the world and found major gaps in the availability of opioid pain medication. While opioid analgesics are relatively available in the United States and Canada, patients in many parts of the world have no access to them. In addition to the 25 million who die in pain, the commission estimated that another 35 million live with chronic pain that is untreated.

“The fact that access to such an inexpensive, essential, and effective intervention is denied to most patients in low-income and middle-income countries and in particular to poor people -- including many poor or otherwise vulnerable people in high-income countries -- is a medical, public health, and moral failing and a travesty of justice,” the Lancet commission found.

"Unlike many other essential health interventions already identified as priorities, the need for palliative care and pain relief has been largely ignored, even for the most vulnerable populations, including children with terminal illnesses and those living through humanitarian crises."

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The voluminous report by 61 health experts from 25 countries took three years to prepare. It shared the story of a doctor in India who treated a patient named “Mr S” who suffered crippling pain from lung cancer. The doctor was able to provide him with morphine to relieve his pain, but when Mr S returned the next month, no morphine was available.

“Mr S told us with outward calm, ‘I shall come again next Wednesday. I will bring a piece of rope with me. If the tablets are still not here, I am going to hang myself from that tree.’ He pointed to the window. I believed he meant what he said,” the doctor said.

The commission said there were several barriers that stood in the way of effectively treating pain, including “opiophobia” – prejudice and misinformation about the medical value of opioids.

A prevalent but unwarranted fear of non-medical use and addiction to opioids and opioid-induced side-effects, both among health-care providers and regulators and among patients and their families, has led to insufficient medical use. Unbalanced laws and excessive regulation perpetuate a negative feedback loop of poor access that mainly affects poor people,” the commission said.

“Efforts to prevent non-medical use of internationally controlled substances, such as morphine and other opioid analgesics, have overshadowed and crippled access to opioids for palliative care. These efforts have focused on preventing diversion and non-medical use rather than ensuring access by people with legitimate health needs.”

The commission also blamed the poor state of pain care on a tendency in the medical community to focus on curing and preventing disease, rather than preserving a patient’s quality of life and dignity.  

The report recommends that palliative care be included as part of universal health care coverage and that inexpensive morphine should be available “for any patient with medical need.”

Lessons about Palliative Care from Extreme Measures

By Roger Chriss, Columnist

The book Extreme Measures: Finding a Better Path to the End of Life by Jessica Nutik Zitter, MD, provides essential insights into palliative medicine and end-of-life care. It also gives important ideas for pain management that are all too often overlooked in healthcare today. 

Palliative medicine became a board-certified subspecialty of internal medicine in 2006. Zitter defines it as “an interdisciplinary approach to managing suffering in the context of medical illness, whether physical, emotional, familial, or spiritual.”

The importance of palliative care cannot be understated. As Zitter explains, over 50 percent of Americans die in pain, and 70 percent die in hospitals, nursing homes and other institutions.

The book opens with Zitter describing her background in medicine and how she came to appreciate the value of reducing the suffering and easing the process of death in the terminally ill.

“It took the palliative care movement to teach me that treating pain early on was one of the most important things I could do for my patients -- almost as important as maintaining blood pressure or treating infection,” she wrote.

American healthcare has focused on preserving life at all possible costs, often without respecting the desires or values of the patient. This is clearly visible in long-term acute care. Zitter tells us that annual admissions to acute care facilities tripled between 1997 and 2006, rising from 13,000 patients to more than 40,000. Of those 40,000 patients, 30 percent were partially or fully dependent on intensive interventions such as mechanical ventilation.  

Zitter calls this a treatment treadmill, a form of healthcare inertia that moves a person along to more aggressive interventions, even when there is essentially no hope of clinical benefit. She describes cases from her own professional experience, including a pancreatic cancer patient whose treatment team at New York Presbyterian was ready and willing to continue chemotherapy with curative intent, despite the spread of metastatic disease and the patient’s deteriorating health. 

In reference to such treatment, Zitter cites the remarks of Charles Blanke, MD, an oncologist, and Erik From, MD, a palliative care physician: “If an oncologist suspects the death of a patient in the next 6 months, the default should be no active treatment.”

In other words, chemotherapy should be given with palliative, but not curative intent.

“Let us help patients with metastatic cancer make good decisions at this sad, but often inevitable, stage. Let us not contribute to the suffering that cancer, and often associated therapy, brings, particularly at the end,” they advocate.

Unfortunately, aggressive treatment with curative intent is not limited to “A-Team” physicians at world-class oncology facilities.

Zitter discusses cases of older adults suffering from kidney failure, pneumonia, and cerebral hemorrhage, all subjected to painful and virtually pointless interventions that in some instances may have been against the patient’s wishes. 

The reasons, she says, are multifold. Doctors are caught in legal and ethical binds or may not realize the severity of their patients’ condition.

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One study published in the British Medical Journal found that physicians' estimates of how long patients would live was over five times longer than the actual time they had left.

Similarly, patients may not have a good understanding of their illness or prognosis. Zitter states that “patients are more likely to learn realistic information about their disease trajectory and prognosis while in their doctor’s waiting room than during the actual office encounter.”

The interactions between patients, their families, and treating physicians may also be problematic. Breaking bad news to a patient is difficult for physicians, as Zitter recounts in several places in her book. And this is a problem in medicine in general.

"Doctors with good news were treated as much more compassionate than those with bad news, even when the news was delivered equally empathetically,” she wrote.

The book does not shy away from the ethical challenges of palliative medicine. Zitter relates the story of a patient she calls Mrs. Z, a woman who survived the Holocaust, but was unable to express preferences regarding her care. Zitter explains how difficult the decisions about a patient’s care become when a physician has to guess at the patient’s values and preferences. 

She gives the four principles of bioethics -- beneficence, nonmaleficence, justice, patient autonomy -- as guiding ideas for medical practice. It is not, in her view, a matter of simply “do no harm,” but rather acting in the best interests of the patient while knowing and respecting the patient’s values and preferences. 

Zitter’s focus is patient-centered care, which she states should be “a grounding principle at the core of every subspecialty in medicine, and within the hearts and minds of all physicians everywhere.” The goal is quality of life, restoring or improving function where possible, and easing the act of dying where unavoidable. 

But these ideas go beyond end-of-life care. As Zitter writes at the end of the book: “Palliative care isn’t only for the dying: any patient with serious symptoms or communication needs can benefit.”

She emphasizes this point with respect to pain management: “We should have protocols for a Code Pain like we do for Code Blue.”

The 1903 version of the American Medical Association’s Code of Medical Ethics states: “The medical attendant ought not to abandon a patient because deemed incurable; for, continued attention may be highly useful to the sufferer, and comforting the relatives, even in the last period of the fatal malady, by alleviating pain and by soothing mental anguish.”

We can do much more one hundred years later, but we have to ask ourselves when more becomes too much. Zitter encourages all of us to discuss our healthcare preferences with our family members and clearly document our choices, including those for end-of-life care. Her goal is ultimately the same as ours: to reduce pain and suffering throughout life. 

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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.

Why the CDC Needs to Recognize Palliative Care

By Barbara Nelson, PhD, Guest Columnist

A little over a year ago, the Centers for Disease Control and Prevention released its “Guideline for Prescribing Opioids for Chronic Pain.” Its goal is to help reduce the raging and heartbreaking overdose epidemic in the U.S.

Unexpectedly, the guideline has exposed the extraordinary need for palliative care for millions of patients who may live for decades with intractable pain. These patients now face enormous obstacles getting medically-needed opioids for effective pain control, especially when the dose exceeds the highest recommendation made in the guideline of 90 morphine milligram equivalents (MME) per day.

This unbending recommendation is too low to provide pain control that will keep many intractable pain patients out of agony.  In the last year, untold numbers of chronic pain patients requiring palliative care lost the correct opioid dose for their diseases -- making work, self-care, and family interactions harder or impossible.

I have seen this suffering, both personally and professionally.  I have an incurable and progressive neurological pain disease that, before diagnosis and some pain control, left me unable to read. My disorder profoundly changed my life as I previously knew it.

The dosage recommendations in the CDC guideline show no compassion for those with intractable pain, who will probably need higher opioid doses for the rest of their lives. Only later, when faced with terminal illness and imminent death, will official support for adequate pain control be acknowledged.

How Did We Get Here?

The objective of the guideline was to reduce opioid addiction and overdoses by limiting the dose and duration of prescriptions written by primary care doctors.

The guideline begins with support for “appropriate and compassionate” pain control for those with chronic pain.  It pays special attention to the chronic pain care needed by those fighting cancer, needing palliative care, or facing terminal illness. These three categories of pain are excluded from the CDC’s suggested highest daily opioid dosages because of their well-researched requirements for higher than average pain control, 

There is a problem to this approach, however.

The differences between these three categories are unclear to many doctors and patients. Most frequently, palliative care is confused with end-of-life or hospice care for cancer.  But palliative care is different from end-of-life care, because in palliative care there is no assumption of imminent death, nor is there a decision to withhold medication that might curtail the disease itself.

Chronic obstructive pulmonary disease (COPD), multiple sclerosis and sickle cell anemia are routinely considered diseases that can require palliative care, and these patients may live decades after their diagnoses.

The CDC guideline defines palliative care “as care that provides relief from pain and other symptoms, supports quality of life, and is focused on patients with serious advanced illness. Palliative care can begin early in the course of any serious illness that requires excellent management of pain or other distressing symptoms.”

Not all diseases requiring palliative care also require opioids.  But those patients who require both palliative care and opioids are virtually invisible in the guideline.  Invisible patients get neither appropriate nor compassionate pain care.

The Need for a Palliative Care Appendix

The CDC should produce an appendix for all prescribers – not just primary care doctors – that would help them provide fully adequate pain relief to palliative care patients with life-long pain rather than near-death pain.  

The appendix could start by examining the legislative or regulatory language used in the 13 states that define intractable pain and that allow higher than typical opioid dosing.  The appendix also needs to emphasize research on the most painful long term diseases, which will offer physicians a wider variety and more specialized array of treatment options than is available from a focus on generalized chronic pain. 

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The appendix could begin with the recognition that intractable pain patients needing palliative care do not get “high” or “euphoric.” Opioids are medicines that reduce pain and let them live closer to normal lives.

Helping physicians assist patients in organizing self-directed palliative care is another necessity, because most patients will not have access to a palliative care practice, let alone to one that is appropriate for their conditions. 

For patients with rare diseases, the CDC should emphasize the role of the doctor as learner as well as expert, as he or she must take the time to become familiar with a disease they may have never seen before. 

Yes, there may be some patients who attempt to scam the palliative care approach. However, I doubt that this kind of long-term pain is easily faked. The CDC guideline itself asks physicians to make dozens of new medical judgments. Acknowledging intractable chronic pain patients who require palliative care is just one more.

If the CDC does not add a palliative care appendix to the guideline, perhaps the American Academy of Pain Medicine, the American Medical Association or the American Academy of Hospice and Palliative Medicine could convene a group of all stakeholders to thoughtfully discuss the issues of pain treatment within palliative care.  Civil rights organizations that focus on inequality, including medical inequality, could contribute to this effort. 

Groups outside the CDC could also expand the mandate beyond training primary care physicians about opioid dosages, to include pain treatment for diseases requiring palliative care.

The conflict over opioid guidelines that are treated as laws or regulations, instead of recommendations, is not going away.  Several states, insurers and federal agencies have adopted versions of the CDC guideline, and others are sure to follow.  

Providing adequate pain control to palliative care patients would not make legislators, regulators or citizens any less committed to reducing misuse of opioid prescriptions.  In fact, drawing attention to palliative care would demonstrate a welcome dose of wisdom that millions of Americans would applaud.

Without an appendix to the CDC guideline or some other booklet that promotes correct palliative pain care, how will outstanding doctors be protected from unwarranted intrusions by insurance companies and drug enforcement organizations?  How will patients who deal correctly with pain that most people can’t imagine receive the palliative care that they deserve? They won’t.

The CDC’s “one-size-fits-all” guideline is bad medicine and bad policy. It ignores millions of intractable pain patients who require higher opioid doses.  

Everyone needs to recognize the importance of palliative care. You may need it someday. And unless changes are made, you won’t get appropriate medication either.

Barbara J. Nelson, PhD, is Dean Emerita of the UCLA Luskin School of Public Affairs and is Professor Emerita of UCLA’s Public Policy Department. She is the founder of The Concord Project, which builds social capital that allows people from divided communities to work together on projects of mutual benefit.

Barbara also directed The Leadership and Diversity Project, improving policy education and policy making through creative inclusion and enacted equality.  She served on the board of the Greater Los Angeles United Way.

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.