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The guidelines were withdrawn after two U.S. congressmen released a report that accused WHO of being “corruptly influenced” by Purdue Pharma and other opioid manufactures when it developed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.


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.

WHO Recognizes Chronic Pain as Disease With New Coding System

By Pat Anson, PNN Editor

The World Health Organization has adopted a new classification system for chronic pain, assigning it the code ICD-11 in a revision of the International Classification of Diseases (ICD). It’s the first time the ICD will include a specific diagnostic code for chronic pain, along with sub-codes for several common chronic pain conditions. 

The new classification system is important because it treats chronic pain as a distinct health condition and as a symptom to an underlying disease. It also takes into account the intensity of pain, pain-related disability, and psychosocial factors that contribute to pain.

“The inclusion of the new classification system for chronic pain in ICD-11 is an important milestone for the pain field,” says Lars Arendt-Nielsen, MD, President of the International Association for the Study of Pain (IASP), which headed a task force that developed ICD-11.

The new coding system will make it easier for physicians to diagnose, classify and get treatment for chronic pain patients. Insurers will use the new codes to authorize payments and researchers can use them to more easily track and measure the effectiveness of therapies. That’s the good news. 

The bad news is that the ICD changes won’t formally take effect until January 1, 2022. 


Under the current system, chronic pain conditions are poorly categorized under the code ICD-10, which makes it difficult for complex conditions such as fibromyalgia and Complex Regional Pain Syndrome (CRPS) to be classified. That led some physicians to diagnose patients with unexplained pain as having a somatic symptom disorder. 

“A diagnosis of somatic symptom disorder implies that the pain is caused by a behavioral, that is, mental condition. However, it is not appropriate to diagnose individuals with a mental disorder solely because an alternative medical cause cannot be established,” Jaochim Scholtz, MD, an IASP task force member, explained in Practical Pain Management.  

Under the new coding system, patients with fibromyalgia or CRPS could be classified as having a “primary pain” disorder, one of seven new sub-codes for chronic pain conditions:

  1. Chronic primary pain

  2. Chronic cancer-related pain

  3. Chronic post-surgical or post-traumatic pain

  4. Chronic neuropathic pain

  5. Chronic secondary headache or orofacial pain

  6. Chronic secondary visceral pain

  7. Chronic secondary musculoskeletal pain.

There is some overlap between the different diagnostic codes. For example, neuropathic pain can be a symptom of cancer or chemotherapy, while trigeminal neuralgia could fall under neuropathic or orofacial pain. The idea is to give physicians a range of codes to choose from instead of the limited choices they have today.

“The integration of chronic pain in ICD-11 sends a strong signal that pain will achieve appropriate representation in this international standard for reporting diseases and health conditions,” said Scholtz. “The coding system also provides fundamental information for the identification of health trends and healthcare planning. It is widely hoped that the new systematic classification of chronic pain in the ICD-11 will support epidemiological, and other research that is essential for the development of future health policies.”

The classification system was outlined in a free online article published in the January 2019 issue of PAIN.

Strong Support for Cannabis Rx in Comments to FDA

By Pat Anson, Editor

The Food and Drug Administration may have gotten more than it bargained for when it asked for public comments about the medical value and abuse potential of 17 different drugs.

The agency wound up getting over 6,400 comments in the Federal Register, the vast majority of them from people advocating for cannabidiol (CBD) -- one of the active ingredients in medical marijuana.  

Unlike tetrahydrocannabinol (THC), the substance in marijuana that makes people high, CBD-based oils and medications relieve pain, and are increasingly being used to treat a variety of medical conditions.  

“CBD's are not a way to get high as THC is. These oils have so many beneficial uses for anxiety, stress, pain, joint issues, muscular issues, arthritis, seizures, Parkinson's, cancer,” wrote Tami Camp in her public comment. “We need natural herbs, not man-made poisons!”

“CBD helps me with my chronic nerve pain, in a way that prescription medications can't match,” wrote Jason Turgeon.

“I've been consistently using CBD oil now for three months and have noticed an uptick in my moods, a reduction of joint pain, and my sleeping cycles at night have improved as my sleep is deeper and I wake up feeling refreshed,” wrote Kerry Meier.

Public opinion polls show that these are not isolated comments or marijuana supporters trying to game the system by flooding the Federal Register with comments. A recent poll by CBS News found 85% of Americans favor medical marijuana use.

drug policy alliance photo

drug policy alliance photo

But while medical cannabis may be legal in 29 states and the District of Columbia, marijuana is still classified as an illegal Schedule I controlled substance by the Drug Enforcement Administration, right alongside heroin and LSD.

The FDA opened the cannabis can of worms at the behest of the World Health Organization (WHO), which is not only reviewing the safety and effectiveness of CBD, but 16 other drugs -- including pregabalin, tramadol, ketamine, and several chemical cousins of fentanyl, a synthetic opioid blamed for thousands of overdose deaths. 

WHO is seeking input from the FDA on whether international restrictions should be placed on any of the drugs. Under the Controlled Substances Act, the FDA was required to seek public comment in the Federal Register before responding to WHO -- perhaps not anticipating the overwhelmingly positive response that CBD would get. 

“Cannabidiol should not be restricted because CBD is not addictive, nor does it have the potential for abuse nor should it be tied to hallucinogenic drugs. Therefore, no international restrictions should be placed on CBD,” wrote Steve Easterly.

“For cannabis to be scheduled as a class I drug is ludicrous especially when the entire prohibition of cannabis was based on lies,” wrote Mike Copple. “What a shameful spectacle that we the people still have to argue about the usefulness of the cannabis plant. Cannabis has and continues to help me in many ways both physically and mentally.”

“I want cannabis to be legalized and available for over the counter sale. I have known several people who have benefited for various conditions from anxiety, depressions, MS, arthritis and epilepsy,” wrote Nancy Scott-Puopolo.

The public comment period ended on Wednesday. You can look at other responses in the Federal Register by clicking here

Mixed Reviews of Lyrica

There were only a few dozen comments about pregabalin (Lyrica), a prescription medication that millions of Americans take for fibromyalgia, neuropathy and other chronic pain conditions. As PNN has reported, WHO is investigating reports that pregabalin is being abused by addicts.

“Patients are self-administering higher than recommended doses (of pregabalin) to achieve euphoria, especially patients who have a history of substance abuse, particularly opioids, and psychiatric illness,” WHO told the FDA..

The public comments about pregabalin were mixed at best.

“I have been on several medications prior to being switched to Lyrica about six months ago. I actually feel nothing while taking the drug, and assume you would indeed have to take lots to maybe feel high,” wrote Mary. “Not sure if it helps my fibromyalgia or not since I still have lots of pain.”

“I take pregabalin in Lyrica form twice a day currently for nerve pain and fibromyalgia. I cannot accurately express the relief this has brought me,” wrote Renee.

“I have tried many, many medications. When I tried Lyrica, the side effects were horrible. I couldn't even lift my head without severe dizziness and the room spinning,” said Lora Berry.  

“I take Lyrica and all I got from it was fatter,” said Debra Winegar. “CBD oil is wonderful. Take a few drops under the tongue and I'm good to go. Narcotics are needed when my pain is out of control. I'm tired of waiting to be pain free. Legalize pot now!”

Will the FDA now report to WHO that thousands of American citizens want CBD-based medications fully legalized?  The FDA notice in the Federal Register only notes that public comments “will be considered” when the FDA prepares its scientific and medical evaluation. The FDA report to WHO is due September 30.

WHO Lists Fentanyl as ‘Essential Medicine’

By Pat Anson, Editor

At a time when hundreds – perhaps thousands – of Americans and Canadians are dying every month from overdoses of illicit fentanyl mixed with heroin or turned into counterfeit painkillers, it’s easy to lose sight of the fact that prescription fentanyl is an important and useful analgesic.  

We were reminded of that today by the World Health Organization (WHO), which added fentanyl skin patches and methadone to its list of essential medicines for treating cancer pain. WHO’s Essential Medicine List is not widely followed in developed countries – where prescription drugs are widely available – but it is used in many third world countries to guide decision making and increase access to medicines that are often in short supply.

"Safe and effective medicines are an essential part of any health system," said Dr. Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation. "Making sure all people can access the medicines they need, when and where they need them, is vital to countries’ progress towards universal health coverage."

Fentanyl patches and methadone are two of the 30 drugs being added to the Essential Medicine List, raising the total to 433 medicines considered vital in addressing public health needs. WHO also added drugs for treating HIV, hepatitis C, tuberculosis and leukemia; and gave new advice about the use of antibiotics.

While illicit, black market fentanyl has become a deadly scourge across the U.S. and Canada, prescription fentanyl is legally available in patches, lozenges and sprays to treat severe pain.  

WHO’s inclusion of fentanyl patches and methadone on the essential list is limited to the treatment of cancer pain. An expert panel that reviewed the medicines noted “there is a need for additional opioid treatment options” for cancer pain. About a third of cancer patients worldwide are undertreated for pain, and patients living in low or middle income countries often have limited access to opioid painkillers.  

Other opioids already on the essential list (for treating pain and palliative care) are codeine, morphine, hydromorphone and oxycodone . Aspirin, ibuprofen and paracetamol (acetaminophen) are on it too, although the latter is “not recommended for anti-inflammatory use due to lack of proven benefit.”

Gabapentin Rejected

It’s also worth noting the medications that did not make the updated WHO list. Tramadol was not approved as a treatment for cancer pain, while gabapentin (Neurontin) was rejected as a treatment for neuropathic pain.

WHO’s expert panel gave a scathing review of the application made by the International Association for the Study of Pain and the International Association of Hospice and Palliative Care for the inclusion of gabapentin; noting there were many cases of bias and data manipulation in the clinical studies used to support it. Also noted was the $430 million fine paid by Pfizer in 2004 to settle civil and criminal charges for a “marketing scheme” to promote Neurontin for unapproved uses.    

“The Committee acknowledged the serious issues on publication and outcome reporting bias as important ones,” the panel said. “The Expert Committee considered the uncertainty in efficacy estimates as a result of publication and outcome reporting biases in the currently available evidence for gabapentin. The Committee did not recommend inclusion of gabapentin on the EML (Essential Medicine List) for neuropathic pain on the basis of its uncertain benefits.”

While gabapentin is approved for neuropathic pain in the European Union and Australia, it is only approved for epilepsy and neuropathic pain caused by shingles in the U.S. Despite that limitation, gabapentin is widely prescribed “off label” to treat depression, anxiety, migraine, fibromyalgia and other chronic pain conditions.  About 64 million prescriptions were written in the U.S. for gabapentin in 2016, a 49% increase since 2011.