How To Get Medical Help for Intractable Pain

By Forest Tennant, PNN Columnist

Americans have been trained and oriented to believe that when making an appointment with a medical provider they will walk in, discuss their health issues and receive good care. Those days are long gone if you need care for a painful disease like Intractable Pain Syndrome (IPS).

It is common for persons with IPS to forget how rare this condition is compared to more prevalent diseases such as asthma, diabetes and hypertension. Any person with IPS also has to face the sad fact that the media, government and mental health professionals have condemned and painted every person with IPS as a drug abuser who is not worthy of being trusted with an opioid, benzodiazepine or adrenaline type stimulant.

Things have gotten so out-of-hand that most doctors are afraid to treat pain for fear of government penalties or condemnation by their peers, hospital or malpractice insurance carrier. Many veterans’ hospitals and private health plans now essentially ban the prescribing of opioids.

State and federal policies also make it difficult to travel long distance to access treatment, as that may be seen as a “red flag” that a patient is doctor shopping or visiting a pill mill.

Whenever possible, persons who have IPS should pursue physicians and nurse practitioners in their local community to provide necessary care.

Here are some tips we recommend when visiting a local medical provider for the first time:

1. Do not refer to yourself as a “pain patient,” but as a person with a disease that causes pain. Tell providers what condition you have been diagnosed with: “I have adhesive arachnoiditis, neuropathy, Ehlers-Danlos Syndrome, etc.” 

2. Put together a complete set of documented medical records and bring them to every appointment, including personal identification, local address, insurance coverage, medical diagnosis, MRI’s, lab tests, and list of past treatments. Your records should be neatly organized in a 3-ring binder or file folder.

3. Know your state’s opioid prescribing guidelines and regulations. Do not ask physicians or pharmacists to violate these rules. 

4. Research and understand your disease and carry written materials about it to your medical providers.

5. Identify a local pharmacy and health food store in your community that will fill your prescriptions and carry the supplements you need. Don’t ask a doctor to find you a pharmacy.

6. Know and be able to describe the complications of your constant pain, such as hypertension, tachycardia, elevated cholesterol, diabetes, autoimmunity and hormone deficiencies.

7. Until regular care is established with a provider, a family member -- ideally a spouse -- should attend all appointments to help build credibility and assurance with the provider.

8. Know the name and dosage of every drug and supplement you take, and which ones treat the cause of your pain, suppress the pain, or treat a complication of your pain.

9. Plan on having multiple medical practitioners to treat your conditions. For example, your primary care physician may treat your hypertension or hormone deficiencies, but a neurologist may treat the pain.

10. Due to opioid restrictions, identify non-opioid substances that will substitute or potentiate whatever opioid may be available in your community. Some examples: kratom, CBD, palmitoylethanolamide (PEA), ketamine, oxytocin.

11. Develop a care plan of non-prescription agents to treat the cause of your pain, suppress inflammation and boost hormone levels. 

Know Your Diagnosis

You must have a verifiable, anatomic diagnosis that is the cause of your IPS. The fact that you have intractable pain is not sufficient. You must know the cause of it.

An anatomic diagnosis requires a physical examination plus confirmation with an x-ray, MRI, photograph, blood test, elector-conduction study or biopsy. This information must be documented in your medical record. Equally important is to keep a copy of all test results in your personal possession -- not in some doctor’s office.

Two cases offer examples of mistakes patients can make when when visiting a provider for the first time:

1) A woman consulted with us who was taking three different opioids that had quit providing pain relief. When asked what caused her pain, neither she nor her husband knew. They could not provide an answer.

2) A woman on two opioids and three ancillary agents wanted a letter to support her disability claim. When asked the cause of her pain, she didn’t know, except that her feet and legs hurt, and someone told her she might have fibromyalgia.

Neither of these patients could produce a single page of medical records stating the cause of their pain. Not surprisingly, they also couldn’t locate a doctor to help.

The following are not considered specific enough diagnoses to obtain opioids or disability: bad back, sciatica, failed back, sprain or strain, fibromyalgia, headache, accident, EDS, neck pain or pain from a fall. 

Persons who have IPS or chronic pain are usually taking several drugs, including controlled medications, but don’t always know why they are taking them. If you don’t know why you are taking a drug, you may appear to medical practitioners to simply be a drug seeker who abuses medication or has an addiction or opioid use disorder.  

If you can’t explain in detail why you take each medication, including supplements, you shouldn’t be taking them. No MD or nurse practitioner will prescribe them to you if you don’t know why you are taking them. That is why it is imperative that you learn as much as you can about each medication and supplement you are taking. 

If the only care you are seeking is for temporary, symptomatic pain relief with opioids or benzodiazepines, don’t expect to find pain care. Also, don’t expect acceptance from local practitioners unless you are taking medications to treat the cause of your pain and to permanently reduce your pain. 

Forest Tennant is retired from clinical practice but continues his research on intractable pain and arachnoiditis. This column is adapted from newsletters recently issued by the IPS Research and Education Project of the Tennant Foundation. Readers interested in subscribing to the newsletter can sign up by clicking here.

The Tennant Foundation has given financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

Study Finds Little Evidence to Support Use of Acetaminophen

By Pat Anson, PNN Editor

Acetaminophen is the most widely used over-the-counter pain reliever in the world — the active ingredient in Tylenol, Excedrin, and hundreds of pain medications. The U.S. Centers for Disease Control and Prevention considers acetaminophen a “first-line” treatment for low back pain, osteoarthritis and migraine.

But a comprehensive review published in the Medical Journal of Australia found little or no evidence to support the use acetaminophen for most pain conditions. Researchers at the University of Sydney analyzed 36 studies involving over 19,000 people and concluded that the pain-relieving benefits of acetaminophen – known as paracetamol outside the U.S. -- are modest, at best.

“For most conditions, evidence regarding the effectiveness of paracetamol is insufficient for drawing firm conclusions. Evidence for its efficacy in four conditions was moderate to strong, and there is strong evidence that paracetamol is not effective for reducing acute low back pain,” wrote senior author Christopher Maher, PhD, a professor at the Sydney School of Public Health.

Maher and his colleagues looked at 44 pain conditions often treated with paracetamol, and could find only four for which there is high-quality evidence:

• Knee and hip osteoarthritis

• Tension headache

• Perineal pain after childbirth

• Craniotomy

Evidence for the other 40 pain conditions was low quality or inconclusive, including:

• Acute and chronic low back pain

• Major surgery

• Dental surgery

• Migraine

• Rheumatoid arthritis

• Hip fracture

• Cancer pain

• Neuropathic pain

“While paracetamol is widely used, its efficacy in relieving pain has been established for only a handful of conditions, and its benefits are often modest. Although some trials have evaluated regimens that may have underestimated its utility, the clinical application of paracetamol is primarily guided by low quality evidence, at best,” researchers said.  

A 2015 study in the British Medical Journal also found that paracetamol was ineffective for low back pain and provided little benefit to people with osteoarthritis.

In recent years, some U.S. hospitals have started using paracetamol as an alternative to opioids for post-operative pain, a practice not supported by the Australian study.

One limitation of the University of Sydney review is that most of the studies that were evaluated only used a single dose of paracetamol, which does not reflect its typical use.  Perhaps for that reason, researchers found that adverse events were similar for patients receiving paracetamol or a placebo.

Over 50 million Americans use paracetamol (acetaminophen) each week to treat pain and fever. Long-term use has long been associated with liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

CDC Won’t Say Who Is Writing Update of Opioid Guideline

By Pat Anson, PNN Editor

When the Centers for Disease Control and Prevention released the draft version of its opioid prescribing guideline in September 2015, the agency was roundly criticized for its secrecy and lack of transparency.

There were no public hearings. The CDC initially refused to identify who wrote the guideline or who its advisors were. And the public was given just 48 hours to comment on the guideline after a botched online webinar that presented only a summary of the recommendations.     

After a congressional investigation and threats of a lawsuit for “blatant violations” of federal laws, the CDC changed course and opened up the guideline to public scrutiny and a 30-day comment period. After a few minor changes, the guideline was released in March 2016.

Five years later, after a tsunami of complaints that the guideline’s recommended dosage limits have been harmful to patients and failed to reduce opioid addiction and overdoses, the CDC is now in the process of rewriting the guideline.

There’s more transparency this time around. The public was given an early invitation to comment and nearly 5,400 people wrote to the CDC about their concerns.  The agency also released the names of the “Opioid Workgroup,” a diverse group of physicians, academics and patients that is advising the agency as it updates the guideline.     

But one thing hasn’t changed: the CDC won’t identify who is writing the guideline update.

“Primarily CDC scientists are involved in drafting the update,” Courtney Lenard, a CDC spokesperson, explained in an email to PNN. “Many CDC staff are working on the process of updating the 2016 Guideline, including reviewing the scientific evidence; analyzing patient, caregiver, and provider input gathered during the public comment period and conversations held earlier in 2020; and drafting its content.”

The updated guideline will be only reviewed by the Opioid Workgroup, which has been given no direct role in writing it or in making revisions. The workgroup is expected to give its recommendations to the Board of Scientific Counselors at the CDC’s National Center for Injury Prevention and Control sometime this summer.

“At that time the authors of the draft Guideline will also be announced,” said Lenard, adding that the public likely won’t see the draft until late 2021, when it is published in the Federal Register.

Potential Conflicts of Interest

Only after another round of public comments will the revised guideline finally be released in 2022 – a full six years after the initial guideline. Some patient advocates worry about a lack of urgency at CDC and that too much is occurring behind closed doors.  

“I remain concerned about an ongoing lack of transparency in the development of an update to the CDC Pain Guidelines,” said Dr. Chad Kollas, a palliative care specialist in Florida. “There will be no disclosure about the authorship of the revised guidelines until their release, which effectively eliminates the opportunity to challenge any of their authors’ potential conflicts of interest proactively.”

“The CDC has put together a writing team without addressing transparency or conflicts of interest to our satisfaction,” says Terri Lewis, PhD, a patient advocate and researcher. “This is unacceptable and nonresponsive to the concerns that have been so clearly expressed by both the patient community and the medical communities since 2016.”  

The CDC’s evasive response about who is writing the update raises the possibility that the three authors of the original 2016 guideline are working on the revision: Deborah Dowell, MD; Tamara Haegerich, PhD; and Roger Chou, MD.

In 2019, the trio penned an awkward defense of the guideline in The New England Journal of Medicine, in which they admitted the “misapplication” of guideline was causing harm to patients, but deflected taking any responsibility for it.

Chou’s involvement in the updated guideline would be particularly alarming to critics, because of his advocacy for opioid tapering and collaboration with Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

“I'd give long odds that Roger Chou is a member of the current CDC writers group,” says Richard Lawhern, PhD, a prominent advocate in the pain community. “Talk about giving the fox the keys to the hen house!” 

In addition to his work on the 2016 guideline, Chou has authored numerous articles on pain management in peer-reviewed medical journals, many of them critical of opioid prescribing.

Chou is listed as an “external reviewer” on a PROP guide promoting “Cautious, Evidence-Based Opioid Prescribing” that at one time was posted — unedited — on the CDC’s website.

In 2019, Chou co-authored an article with PROP President Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to consider tapering “every patient receiving long term opioid therapy.”

And in 2011, Chou co-authored another op/ed with PROP founder Dr. Andrew Kolodny and PROP vice-president Dr. Michael Von Korff, calling for a major overhaul of opioid guidelines, which were then primarily written by pain management specialists.

“Guidelines for long-term opioid therapy should not be developed by the field of pain medicine alone. Rather, experts from general medicine, addiction medicine, and pain medicine should jointly reconsider how to increase the margin of safety,” Chou and his co-authors wrote, a call to action that came to pass five years later at CDC with a guideline that he helped write.

“I do not believe the CDC should be writing opioid guidelines,” says Dr. Lynn Webster, a PNN columnist and past president of the American Academy of Pain Medicine.  

“The authors of the CDC guideline should not have been tasked with creating the guideline for a few reasons. First, this was outside their areas of expertise. Second, they failed to understand how misguided arbitrary limits of morphine milligram equivalents were in recommending dosing to people in pain. Third, they lacked compassion for people in pain and an understanding that, for some patients, opioids were the only effective, available treatment.”  

Should Chou Be Recused? 

Chou is a primary care physician who heads research at the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University. He was the lead investigator for a recent report by the Agency for Healthcare Research and Quality (AHRQ) that found opioids have only “small beneficial effects” when prescribed for chronic pain and “do not appear to be superior to nonopioid therapy.”

Chou’s report, along with four other AHRQ reviews of pain therapies, were commissioned by the CDC. The reports are being used as key resources by the agency as it updates and possibly expands the opioid guideline to include recommendations for opioid tapering, short-term acute pain, migraine and other pain conditions. 

Some advocates believe Chou is so biased against opioids he should be recused from any further work on the guideline.

“I agree with that. He’s clearly published things and said things. He is not objective on dealing with people who need high dose opioids. It’s just as simple as that. He’s going to oppose anything that allows people to take opioid drugs,” says Forest Tennant, a PNN columnist and intractable pain expert. “They never put people on there who are for opioids. It’s always against.”

“Absolutely he should (be recused). Dr Chou is in the position of being given an opportunity to defend his earlier misdirected, unscientific, and ethically unsound work by influencing the revised guidelines to confirm his earlier positions. This is a ‘professional’ self-interest at least equally as meaningful of any financial relationship,” said Lawhern. 

“The harm the 2016 guideline caused should be sufficient reason to find a new group of individuals to work on the updated recommendations. Having the same authors work on the same guidelines makes it almost inevitable that the same mistakes will be made,” says Webster.

“To paraphrase Albert Einstein, it is insanity to do the same thing again and expect different results. If you want better results, you have to do something differently. I can see that the updated guideline will lack consideration for patients as individuals, just as the 2016 guideline did.”

For much of the past year, the CDC has been preoccupied dealing with fallout from the COVID-19 pandemic. The agency’s once-sterling reputation has been damaged by political interference and shifting recommendations on how to control the virus. The agency’s focus in 2021 is likely to remain on COVID-19.

Pain sufferers and their advocates worry that revising the opioid guideline will not be a top priority at CDC, and that many of the same mistakes made five years ago are being repeated.    

“There is no indication that CDC is treating this with the respect it deserves or with the scientific rigor it demands in spite of mounting evidence that the management of prescription opioids in the USA is 'going off the rails' and that very real systemic and structural harms are accruing to patients and the health care delivery system in general,” says Terri Lewis. 

“I think it fair to say that we all fear that, based on what we are aware of at the moment, this next round of 'revision' will simply amount to an 'expansion' into territory for which there is almost no verifiable evidence and very weak support in the existing literature.”

Why President Biden Must Act on Stem Cells

By A. Rahman Ford, PNN Columnist

In a recent Forbes article, Jake Becraft argues that biomedical manufacturing must receive similar federal investment as technology infrastructure if all Americans are to have equitable access to emerging medical technologies like stem cell therapy.

Becraft notes that -- unlike the rollout of 5G wireless technology, which received substantial public and private investment -- healthcare distribution bottlenecks have received much less attention.

 “If 70% of Americans should have access to 5G, why shouldn’t they also have access to live-saving therapeutics?” asks Becraft, who is the founder and CEO of Strand Therapeutics. “What good is gene therapy to cure blindness if only those with an extra $850,000 in their pocket and home near an urban center can access it?

“If we invest in the fair and equitable distribution of life-saving therapeutics across the country, and not just in the medical hubs of major cities, we could make cell and gene therapies as accessible as we have aimed to make 5G. Cures shouldn’t exist only for the privileged.”

For Becraft, true next-generation health access requires a revolutionizing and re-imagining of healthcare manufacturing and delivery, which would consequently speed the development of cell therapies.

A Broken Stem Cell Infrastructure

Becraft’s argument cuts to the heart of the stem cell accessibility divide, which is especially true with regard to autologous stem cells that are derived from a patient’s own body fat, bone marrow and other tissues.

Harvesting, processing and administering autologous stem cells is relatively simple, cheap and can be done in one day.  Clinicians around the world have been using these therapies to treat or even cure autoimmune diseases and orthopedic problems that are often poorly treated with conventional medical modalities,

But autologous stem cells are currently heavily regulated in the U.S. because the Food and Drug Administration considers a person’s own stem cells to be “drugs” and thus subject to the long, arduous and expensive clinical trial process.

Other countries have more relaxed stem cell regulations. This means that professional athletes and wealthy people can simply fly to Europe or Columbia to receive potentially life-saving therapy. Meanwhile, the average American – many of whom are financially devastated by COVID-19 – is left to languish and suffer.

Clearly, the incrementalism and gradualism that has for too long pervaded and permeated medical technological progress must give way to thoughtful, purposeful and conscious revolutionary reconsideration.

A ‘New Deal’ for Stem Cells

Up to this point in his nascent administration, President Biden has not made stem cell accessibility and affordability a priority. Yes, there are several clinical trials underway for stem cell candidates to treat the symptoms of COVID-19. And, to the FDA’s credit, these trials are being expedited.

But thick federal bureaucratic fog still stifles the commercialization of emerging stem cell modalities that Americans in pain so desperately need. The FDA has yet to approve a single stem cell product as a treatment for arthritis or any orthopedic condition.

Almost one year ago, I wrote that then FDA Commissioner Stephen Hahn had the opportunity to implement a stem cell “New Deal” that would provide much-needed clarity to the regulatory landscape by vesting the states with primary authority over autologous stem cells.

The “New Deal” baton has now been passed from the Trump administration to President Biden, who can help lead us the finish line of stem cell accessibility and affordability. His administration has an opportunity to make good on its pledge to do right by the American citizenry it has pledged to serve. President Biden, the American people are counting on you.

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

The Pain Community Needs More Unity and Awareness

By Carol Levy, PNN Columnist

My column last month, “It’s Time for People in Pain to Be Heard,” received a lot of comments on PNN and in social media.

Most often the writer wrote about why or how they had been hurt by the implementation of the CDC opioid guideline. Several people commented that it’s not because they're too busy to become involved, they’re just in too much pain to advocate for themselves.

One poster told the story of a recent pain rally held at their state capitol. It was a real-life case of what if you threw a rally and no one came? Only one person showed up, defeating the point of the rally. The writer did not mention how many had said they would be there, but I imagine the number had to be more than one.

Yes, the pain stops us from doing many things. Yes, our complaints about how the battle against opioid prescriptions has made us the bad guys, has scarred us, and made our lives so much harder are true. But saying it only on PNN, Twitter, Facebook and other social media sites does not help the cause.

It helps us and only us, by giving us an outlet to express our anger and frustration about how our minds and bodies are affected when our medications have been reduced or stopped. The problem is that by speaking out only among ourselves, the rest of the world hears silence.

When we say the pain is what keeps us from going out and protesting, maybe we need to look at the many walks against cancer, Alzheimer's, multiple sclerosis and other diseases. Many of the people involved in those walks are not the patients themselves, who often cannot participate because of their illness. It is their family, friends and colleagues.

What if we worked to marshal our families, our friends and our colleagues to march for us?

Most people do not understand what chronic pain is or that it comes in many different forms. They are not educated about Complex Regional Pain Syndrome (CRPS), trigeminal neuralgia and other cranial neuropathies, Ehlers Danlos, and many other diseases and disorders that have essentially claimed our lives.

We have many “Awareness” days. For example, the first Monday of November each year is CRPS Awareness Day; October 7 is Trigeminal Neuralgia Awareness Day; and May is Ehlers Danlos Awareness Month. We who have the disorders may be aware of these days, but how many people in the general population don't know the day or month exists, much less what the disorder is?

To many people, “chronic pain” is merely pain that lasts a long time. CRPS or trigeminal neuralgia are chronic, progressive and often incurable, but to those who are not educated about them, they’re more like a stubborn toothache or ankle sprain that won’t go away.

What if on awareness days we inundate Congress, the news media and social media with letters, emails and tweets? What if we acted as a true group, not individual voices in the wilderness, but as a harrowing cry? Maybe then our voices would finally be heard.

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.

FDA Updates Import Alert for Kratom

By Pat Anson, PNN Editor

Federal health officials may have dropped plans to schedule kratom as a controlled substance, but that’s not stopping the Food and Drug Administration from updating an import alert that gives the agency broad powers to seize shipments of the herbal supplement.

The alert targets dozens of kratom exporters and importers in the United States, Canada, Indonesia, Malaysia and the Philippines, and allows FDA inspectors to detain “without physical examination” dietary supplements and ingredients that contain kratom.  In an email, an FDA spokesperson told PNN the alert was updated for “minor changes” involved with one firm’s listing  

Kratom is an herbal supplement that comes from the leaves of a tree that grows in southeast Asia, where kratom has been used for centuries as a natural stimulant and pain reliever. In recent years, millions of Americans have discovered kratom, using it to self-treat their chronic pain, anxiety, depression and addiction.

The FDA says it has “serious concerns” about kratom because of its opioid-like properties.

“Consumption of kratom can lead to a number of health impacts, including respiratory depression, nervousness, agitation, aggression, sleeplessness, hallucinations, delusions, tremors, loss of libido, constipation, skin hyperpigmentation, nausea, vomiting, and severe withdrawal signs and symptoms,” the alert warns.

The FDA issued its first import alert for kratom in 2012, just as kratom was gaining in popularity in the U.S. Since then, several large shipments of raw kratom or kratom supplements have been seized. One of the largest seizures was in 2018, when 28 tons of kratom were confiscated at a South Carolina warehouse operated by Earth Kratom, a kratom wholesaler and vendor. The kratom was later incinerated.   

Kratom can be sold legally in most U.S. states, but vendors can run into trouble if they claim it can be used to treat medical conditions or market it as a dietary supplement.

A lobbyist for the American Kratom Association, an association of kratom vendors and consumers, said the updated alert is part of the FDA’s “disinformation campaign” against kratom.

“The FDA routinely uses the import alerts in discussions with various stakeholders to highlight their claims that kratom is not ‘legally marketed’ in the United States, and by adding a recent date by way of an update makes it appear to be a recent action,” said Mac Haddow. “The import alert is an abuse of that authority that is supposed to apply to contaminated and adulterated products.

“In fact, the objections listed in the import alerts issued by the FDA technically only apply to importers who are subsequently making illegal therapeutic claims or as a dietary supplement on marketing materials. A bulk kratom importer is not subject to FDA's authority. Kratom processors who make no claims and sell kratom as a food are not subject to any pre-market approval by the FDA.”

Federal efforts to ban kratom in 2016 failed due to a public outcry. Two years later, federal health officials quietly withdrew their request to classify kratom as a Schedule I controlled substance because of “lack of evidence” it can be abused or posed a public health threat. The FDA, however, still maintains “significant potential safety concerns” about kratom. 

A 2020 study funded by the National Institute on Drug Abuse concluded that kratom is an effective treatment for pain, helps users reduce their use of opioids, and has a low risk of adverse effects.

Positive Results From Stem Cell Trial for Knee Osteoarthritis

By Pat Anson, PNN Editor

A California stem cell company has announced positive results from a small, early-stage clinical trial of an experimental stem cell therapy for knee osteoarthritis.  

The Phase 1/2a trial conducted by Personalized Stem Cells (PSC) involved 39 patients with knee osteoarthritis who were given a single injection of autologous mesenchymal stem cells derived from their own body fat. Safety was the primary objective of the trial and there were no serious adverse events reported by the company.

The secondary objective of the trial was to assess the effectiveness of the therapy with the Knee Injury and Osteoarthritis Outcome Score (KOOS), a survey that asks patients about their pain, other symptoms, daily function, quality of life, and recreational activities. Nearly 80% of study participants improved above the “minimal important change” (MIC), with an average improvement over baseline of 2.2 times the MIC.

Osteoarthritis is a progressive joint disorder caused by painful inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine.

Results from the PSC study have been submitted to the FDA for review. The company hopes to get approval for a larger, Phase 2 randomized study of its stem cell therapy later this year.  

“We are pleased at the strong safety profile and efficacy results in this FDA-approved clinical study of stem cell therapy for knee osteoarthritis,” said PSC founder and CEO, Dr. Bob Harman. “We are proud to have reached this milestone in our first FDA approved clinical trial. This data supports our progress in the larger placebo-controlled clinical study.”

Veterinarians Already Using Stem Cells

While the FDA has approved hundreds of clinical trials of stem cells, it has not approved a single stem cell product as a treatment for arthritis or any orthopedic condition. That hasn’t stopped stem cell clinics from offering regenerative medicine to patients or veterinarians from using it on animals.

VetStem Biopharma, the parent company of PSC, pioneered the use of adipose derived stem cells in veterinary medicine. Its laboratory has processed stem cells for nearly 14,000 dogs, cats, horses and other animals for use by veterinarians in the U.S. and Canada.

“The 15 years of veterinary experience with adipose derived stem cell therapy of our parent company, VetStem Biopharma, provided the basis for our FDA study submission and approval and provided valuable insights into the study design and conduct,” said Harman.

In addition to the Phase 2 trial for osteoarthritis, PSC plans to pursue FDA approval for a stem cell trial to treat traumatic brain injuries in humans. A clinical study using PSC’s stem cell platform to treat respiratory distress syndrome in COVID-19 patients is currently underway.

Is Your Spinal Pain Inflammatory or Neuropathic?

By Forest Tennant, PNN Columnist

Every person with Adhesive Arachnoiditis (AA) or other spinal canal disorder needs to determine if their pain is primarily inflammatory, neuropathic or both. Why? The treatments are different.

AA is fundamentally an inflammatory disease that involves two different intraspinal canal tissues: the cauda equina nerve roots and the arachnoid-dural covering of the spinal canal. The inflammation causes damage to the nerve roots, so electricity either can’t pass or it doesn’t pass in a smooth, natural flow.

Nerve damage that blocks or alters electricity conduction is called “neuropathic” pain. AA usually has both inflammatory and neuropathic pain, but the inflammation may resolve and leave behind damaged nerve roots and neuropathic pain.

The inflammatory and neuropathic pain of AA may also develop into Intractable Pain Syndrome, which is constant, incurable pain with cardiovascular, endocrine (hormonal) and autoimmune complications.

Persons with AA usually need to treat both kinds of pain – inflammatory and neuropathic --   but one type may be predominant. A blood test for inflammatory markers is helpful, but not totally diagnostic.

If your pain improves with a trial of ketorolac (1 or 2 injections) or a corticosteroid (Medrol Dose Pak or dexamethasone), you have active inflammation that must be treated. We also recommend botanical anti-inflammatory agents, such as curcumin/turmeric, Andrographis and serrapeptase.

Prescription medications for neuropathic pain include gabapentin (Neurontin), diazepam, carisoprodol, topiramate, Lyrica and Cymbalta.

Every person with AA of the cervical and/or lumbar spines should experiment with topical medications, such as the Salonpas patch, lidocaine gel or patch, Voltaren gel and diclofenac (prescription needed).

Topical medication that is applied and massaged into the skin may dissolve through the tissues to the inflamed or damaged area. On average, you can expect 10 to 25% additional pain relief, plus the potential to permanently reduce your pain. Sometimes topical  medication will relieve painful areas that other drugs taken orally or by injection cannot reach.

Forest Tennant is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from bulletins recently issued by the Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should send an email to tennantfoundation92@gmail.com.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.  

A Virtual Headache on the Hill

By Mia Maysack, PNN Columnist

Last week I was fortunate to attend the 14th annual “Headache on the Hill,” a lobbying event held by the Alliance for Headache Disorders Advocacy (AHDA).  We had the largest turnout ever in participants and number of meetings, although it was a far different affair than previous ones.  

Due to the pandemic and Covid precautions, visits to congressional offices that normally would've taken place in person on Capitol Hill were conducted online via Zoom -- which was an adjustment I was grateful to make.

As a result of doing things virtually, it gave people who ordinarily may not be well enough to attend an opportunity to do so. I feel this is a more inclusive approach and should perhaps remain an option even after this pandemic settles. 

Traveling is extraordinarily strenuous on my health and always requires an extensive amount of recovery time. So the opportunity to lie down in between meetings and have the comforts of home around me -- such as soft lighting and blackout curtains -- made all the difference and helped make getting through the day possible. It also ensures I won't be confronted by weeks on end of flare ups and pain cycles. 

I am proud to represent the state of Wisconsin as a volunteer patient advocate, human rights activist and someone who has lived with intractable head pain to some extent each and every day for almost 21 years as a direct result of a traumatic brain injury.  

Given that there are around 40 million people in the U.S. alone who live with migraine disease, the odds are that you either experience it yourself or know of someone who does.  For those who are privileged not to have migraine, Covid-19 has given you a small taste of how we often exist:  shut in and unable to see loved ones, go to work or do things we enjoy. 

I live with both migraine disease and cluster headaches, which are called “suicide headaches” for good reason.  There's no limit to the chaos, interruption, inconvenience and discomfort these conditions have caused in my life, requiring my full time attention just to manage the symptoms.

The difficult experiences I and countless others have faced in seeking, finding and attempting different forms of treatment is why I continue to advocate -- even when I don't feel up to it. Migraine and other forms of head pain are at the top of the list regarding burden and disability, yet we've been severely limited with treatment options that usually mask the symptoms temporarily, as opposed to addressing the root cause.   

We've seen progress in recent years with more injectable treatment options, after being limited for decades to oral triptans. But insurance for the shots can be a nightmare (if you're fortunate enough to have insurance) and I received what was labeled as a "bad batch" of shots that gave me side effects I am still living with today.   

What We Asked For

Our medical system is set up in such a way that we’re able to receive a prescription relatively easily, but alternative tools such as water therapy, massage, oxygen and mindfulness meditation aren't seriously considered, let alone covered. This is a very real problem.

It also makes no sense that migraine conditions are some of the least funded research areas for the National Institutes of Health. Our “asks” during Headache on the Hill were to devote more funding toward the research and treatment of migraine. Currently there's only $20 million or so being spent. We’re requesting $50 Million designated specifically for NIH research on migraine and headache disorders.  

Additional funding could also help incentivize more providers to obtain neurology-related medical degrees, as there is a severe shortage and need for more headache specialists. More funding is needed to develop new treatments, help cultivate data on the benefits of more holistic approaches, and assist in providing more dignity to those of us who feel invisible and shunned by a system that's supposed to be on our side.  

Furthermore, and perhaps even more disgracefully, hundreds of thousands of our military veterans suffer from traumatic brain injuries as a result of being exposed to explosions and toxic open burn pits.  We asked for another $25 million to double the number of specialized treatment sites that the VA has for veterans with headache disorders. 

These are the individuals who ensure that we possess and maintain the liberties of this country and they deserve the absolute best we have to offer. I know that we can do better on all of these issues and we must. It's time to urge our representatives to follow through and do the right thing.  

You can help by visiting the AHDA website and following the prompts for sending an email to your representatives and senators.  Urge them to fully fund the VA’s Headache Disorders Centers. 

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill. 

The Unintended Consequences of the CDC Opioid Guideline

By Dr. Lynn Webster, PNN Columnist

Jack Schwartz (a pseudonym) is a child of Holocaust survivors. As a small boy, he was traumatized by observing his older brother become addicted to heroin. He also developed a substance use disorder of his own that he believes was due, in part, to childhood PTSD.

A 64-year-old psychotherapist, Schwartz has been in chronic pain since a 1996 car accident injured his neck. Although he has a history of substance use disorder, he has used opioids to manage his pain for the past several years.

His personal physician, who retired at the end of 2020, wrote a letter stating Schwartz has been prescribed Norco (a combination of acetaminophen and hydrocodone), has been compliant, and has shown no signs of abuse for the previous four years. The retiring doctor hoped Schwartz would be able to find someone to continue prescribing his Norco.

Schwartz has not yet found a new physician. In the meantime, his insurance company notified him that they would not pay for his medication, citing the CDC’s opioid prescribing guideline and their own opioid policy, which states that "narcotics are not the treatment of choice for chronic nonmalignant pain."

Schwartz contacted me after reading a PNN column I wrote, "Ironic Partners: Suicide Prevention and Pain Awareness Month." He said he was suicidal and asked me for advice. We agreed that sharing his story might help others in similar positions.

Who Should Write Clinical Guidelines?

Regrettably, Schwartz’s situation is not uncommon. Many insurers and regulators have adopted rigid policies that cite the CDC’s voluntary guideline as if it was the standard of care. The CDC has admitted its guideline is being misapplied and is working on an update, but so far the agency has done little to correct the problem.

In fact, the CDC has gone even further than the guideline, producing a fact sheet for physicians, “Nonopioid Treatments for Chronic Pain,” in which it recommends alternative medications for common chronic pain conditions including migraine, low back pain, osteoarthritis, fibromyalgia, and neuropathic pain.

Why is the CDC making medical treatment recommendations?

Cardiologists and heart surgeons should develop recommendations for managing heart disease. Endocrinologists should offer recommendations for managing diabetes. Infectious disease specialists should make recommendations for managing infections. Addiction specialists should provide recommendations for treating addiction. And it is pain specialists who should develop treatment guidelines for treating pain.

The way it should work is this: Professional organizations representing medical specialties develop treatment guidelines. Whenever possible, input should be solicited from patient stakeholders. The role of government organizations such as the National Institutes of Health, FDA, CDC, and DEA should be to provide data and resources to these groups, so they can initiate and revise treatment guidelines as the science evolves.

Specialists should lead the way to ensure patient care is clinically driven and patient-centered. Non-clinicians, such as government officials — even if they have medical degrees— should not be making treatment decisions or creating guidelines for specialists and their patients.

Walking Back the CDC Guideline

In my view, it was a mistake for the CDC to release the guideline in 2016. Before it was published, I predicted people in pain would suffer and that the guideline would not reduce the number of opioid-related overdose deaths. Unfortunately, I was correct.

Many providers, patients and their loved ones have urged the CDC to revise or withdraw the guideline. The American Medical Association has urged the CDC to make "significant revisions."  

The three co-authors of the guideline, Deborah Dowell, MD, Tamara Haegerich, PhD, and Roger Chou, MD, even wrote a commentary for The New England Journal of Medicine in 2019 acknowledging that their recommendations were being misapplied and were “likely to result in harm to patients.”

The admission that the CDC guideline was harmful was long overdue. Now the question of how the recommendations should be changed must be addressed. Hopefully, the CDC will consider input from people who have been harmed the most by the guideline and will revise their recommendations accordingly.

Jack Schwartz continues to struggle with intractable pain and suicidal feelings. He, and millions of people like him, need for your opinion and your provider’s perspective, to be heard. Maybe then more rational decisions will be made regarding the use of opioids for the treatment of pain.

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. Lynn is author of the award-winning book The Painful Truth, and co-producer of the documentary It Hurts Until You Die. Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. You can find him on Twitter: @LynnRWebsterMD.

Cannabis Users Deserve Better Research

By Roger Chriss, PNN Columnist

This has been a challenging month for supporters of medical cannabis, with two professional pain societies – the Australian and New Zealand College of Anaesthetists and the International Association for the Study of Pain (IASP) both releasing statements saying they do not endorse the use of cannabis to treat pain.

IASP’s position statement came after a two-and-a-half-year review of cannabis studies by researchers at the University of Bath's Centre for Pain Research, who found little evidence to support the use of cannabis for pain control.

“Cannabis seems to attract strong opinions. If ever a field needed evidence and a rigorous scientific opinion it is this one. For many this will be an unpopular conclusion, but we need to face up to the fact that the evidence is simply lacking. Science is not about popularity but keeping people safe from false claims,” said Professor Christopher Eccleston, Director of the Centre for Pain Research

Eccleston and his colleagues published their findings in a series of 13 articles in IASP’s journal PAIN. They found that many cannabis studies had too few participants, tested a single-dose exposure in a laboratory, or the trials only lasted a couple of weeks. Such work can justify further research, but not the clinical use of a drug by patients, which requires long-term studies of safety and efficacy.

"Cannabis, cannabinoids, and cannabis-based medicines are becoming an increasingly popular alternative to manage pain. However, our review shows that there is limited evidence to support or refute their use for the management of any pain condition. The studies we found were poor quality and the evidence was of very low-certainty," said Dr. Emma Fisher of the University of Bath.

Although cannabis has been used for thousands of years for pain and other conditions, there are few good quality studies to support its use, as anesthesiologist Abdul-Ghalliq Lalkhen, MD, notes in his new book, “An Anatomy of Pain.”

“There have so far been only twelve randomized controlled trials on cannabis in the past five years, and most of these studies have indicated that cannabinoids are not effective in the management of neuropathic pain," wrote Lalkhen.

Even when cannabis studies are conducted, they often have disappointing results. Zynerba Pharmaceuticals had high hopes for developing CBD drugs and a transdermal CBD skin patch, but quietly dropped them after disappointing clinical trials.

“Zynerba’s drugs have struggled mightily in the clinic, missing key endpoints and sometimes failing to show dose-dependent responses. Plans for an epilepsy and osteoarthritis drug fell away with clinical failures in 2017. A year later, so did a patch that was meant to deliver their THC through the skin,” Jason Mast reported in Endpoints News.

The lack of good evidence was noted by the Food and Drug Administration when it recently warned two companies illegally marketing over-the-counter CBD products for pain relief:

“It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety,” said FDA Principal Deputy Commissioner Amy Abernethy, MD.

Even when high-quality, placebo controlled trials are conducted, they often fail to replicate the results of lower-quality studies. For instance, cannabis is often touted for post-traumatic stress disorder (PTSD). But a recent clinical trial of cannabis for PTSD found it worked no better than a placebo.

“No active treatment statistically outperformed placebo in this brief, preliminary trial. Additional well-controlled and adequately powered studies with cannabis suitable for FDA drug development are needed to determine whether smoked cannabis improves symptoms of PTSD,” researchers concluded.

The American Medical Association takes a similar view. “Scientifically valid and well-controlled clinical trials conducted under federal investigational new drug applications are necessary to assess the safety and effectiveness of all new drugs, including potential cannabis products for medical use,” the AMA said.

Cannabis users deserve high-quality research. And the medical community deserves respect for not endorsing cannabis before the evidence base is well established. Arguing over low-quality studies does not have the persuasive power of a high-quality clinical trial.

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.

FDA Panels Say New Arthritis Drug Too Risky

By Pat Anson, PNN Editor

Two FDA advisory committees have voted against recommending an experimental non-opioid pain reliever as a new treatment for osteoarthritis, dealing a potential death blow to a drug that’s been under development for 15 years.

On a nearly unanimous 19 to 1 vote, the FDA’s Arthritis Advisory Commitee and Drug Safety and Risk Management Advisory Committee decided that the benefits of tanezumab do not outweigh its possible safety risks, which include the acceleration of osteoarthritis in some patients.  Advisory committee recommendations are not binding on the FDA, but they are likely to carry a good deal of weight when the agency makes a final decision on tanezumab.

Pfizer and Eli Lilly are jointly developing tanezumab, an injectable humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body due to injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from muscles, skin and organs from reaching the brain.

FDA reviewers released a report this week saying tanezumab works as a pain reliever, but the effect “is modest, and there is no convincing evidence of a superior efficacy” over non-steroidal anti-inflammatory drugs (NSAIDs), the current standard treatment for osteoarthritis.

More concerning are the potential side effects of tanezumab, the most serious being rapidly progressing osteoarthritis that is so severe some patients need total joint replacements. Investigators say tanezumab also appears to affect healthy joints and causes “abnormal peripheral sensation” similar to carpal tunnel syndrome.

The side effects of tanezumab have been known for over a decade. The FDA slowed the development of tanezumab and other NGF inhibitors in 2010 because of concerns they make osteoarthritis worse in some patients.

Under pressure to approve more non-opioid pain relievers, the FDA allowed clinical studies of tanezumab to resume in 2015 and two years later gave it “fast track” designation to help speed its development.

Pfizer and Eli Lilly have conducted dozens of clinical trials evaluating the safety and efficacy of tanezumab on more than 18,000 patients. The companies at one time considered, but then abandoned plans to develop tanezumab as a treatment for chronic low back pain after 10% of patients given high doses developed joint pain and other side effects.

Critics say its time to finally throw in the towel on tanezumab.

“The drug is unsafe. It accelerates the underlying joint disease. And according to the FDA, even if you stop the drug early on, there’s evidence you can still progress to having these joint problems,” Michael Carome, director of Public Citizen’s Health Research Group, told PNN.  “The decision here is clear cut. The drug should not be approved. And in our view, no further studies on this drug should be done. Because it would be unethical to continue to expose people to this drug where the harm is clear and there’s no real benefit.”

A Pfizer spokesman said the company would continue to seek approval for tanezumab, despite the committees’ recommendation.

“While we are disappointed in today’s outcome, we continue to believe that the clinical data presented for tanezumab supports its benefit-risk profile,” Jim Rusnak, chief development officer for Pfizer, said in a statement. “The patients whom we aim to help with tanezumab are suffering from significant, debilitating osteoarthritis pain and have exhausted available medical therapies and are hopeful for new, non-opioid treatments. We will continue to work with the FDA to determine next steps.”

Osteoarthritis is a progressive joint disorder caused by painful inflammation of soft tissue, which leads to thinning of cartilage and joint damage in the knees, hips, fingers and spine. The World Health Organization estimates that about 10% of men and 18% of women over age 60 have some form of osteoarthritis.

Kolodny: Critics of CDC Opioid Guideline ‘Twisting the Facts’

By Pat Anson, PNN Editor

The founder of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP) says his organization played only a minor role in drafting the CDC opioid guideline and claims much of the controversy over the guideline was stirred up by pain organizations funded by the pharmaceutical industry.

“Not every group that has harmful advocacy is funded by industry, but the vast majority are. The ones that are not funded by industry work arm-in-arm with industry funded groups,” said Dr. Andrew Kolodny. “They have an agenda. A lot of individuals, journalists, organizations that have weighed in on the opioid crisis have an agenda. And they will try and twist the facts to fit their agenda.”

Kolodny spoke for over an hour Tuesday during a webinar hosted by PharmedOut, a program at Georgetown University that seeks to expose deceptive marketing in healthcare. The webinar was billed as an effort to refute “False Narratives & Manufactured Controversies about the Opioid Crisis,” but it turned into a rambling dialogue by Kolodny that gaslighted pain sufferers, doctors, patient advocates and anyone else critical of the CDC guideline.

“Much of the controversy or the critique of the guideline, almost all of it, was focused on the secretive way in which the guideline had been drafted, not on the actual recommendations. They seemed to stay clear from attacking recommendations, almost all of which were pretty benign,” said Kolodny.

Although voluntary and only intended for primary care physicians, the CDC guideline has become the “standard of care” in the United States for treating pain, with millions of patients taken off opioids or reduced to lower doses in the name of preventing addiction and overdoses.

Many patients say their pain and quality of life are now significantly worse, they have a hard time finding doctors, and some have turned to alcohol and illegal drugs for pain relief. The opioid crisis also continues to grow worse, with a record number of fatal overdoses last year – most of them caused by illicit fentanyl and other street drugs, not prescription opioids.

Even the CDC has recognized that its 2016 guideline has caused “unintended harms,” and the agency is now in the process of updating and possibly expanding its recommendations.

Kolodny brushed aside many of those concerns and instead focused on deflecting attention away from PROP –- at various times blaming Purdue Pharma, the Koch brothers and the Washington Legal Foundation for “manufacturing a controversy around the CDC recommendations.”

“To try and make the guideline controversial, the messaging came out that the guideline has been secretly written by PROP. We started to see mentions in social media and publications describing PROP as a fringe group or as anti-opioid zealots. So the messaging was that the CDC relied on this fringe, anti-opioid zealot group to secretly write the guideline,” Kolodny said. 

As PNN has reported, the CDC guideline was in fact drafted in secret, with no public hearings and little input from patients or pain management experts. Only when threatened with a lawsuit by the Washington Legal Foundation and a congressional investigation did the CDC open up the guideline process to public scrutiny and disclose the identities of its advisors and consultants.

At least five PROP board members were involved in drafting the guideline, although Kolodny claimed there were only three in Tuesday’s webinar.  PROP President Jane Ballantyne and Vice-President Gary Franklin were members of a key advisory panel; David Tauben was on the guideline’s peer review panel; and Kolodny and David Juurlink were on a stakeholder review group.

While technically true that PROP did not write the guideline, PROP had input and key relationships within the CDC. Dr. Roger Chou, one of the guideline authors, has collaborated with PROP members on several occasions, such as writing an op/ed with Ballantyne that encouraged doctors to consider tapering “every patient receiving long term opioid therapy.”

Koldony is also a longtime associate and friend of then CDC Director Thomas Frieden, and has co-authored op/eds with Frieden, including one that recommended taking all high-dose opioid medications off the market.

On September 14, 2015, two days before the first draft of the CDC guideline was even made public, Frieden wrote an email to Kolodny thanking him for his role in preparing it. The email was then forwarded by Kolodny to other PROP members

“I want to personally thank you and your organization’s leadership for serving as members of the Stakeholder Review Group,” Frieden wrote. “We greatly appreciate not only your engagement in this process, but also your willingness to do so within the allotted timeframe. Given the public health toll, we have undertaken a process that will expedite publication while maintaining fidelity to the scientific process.”

We may never know the full extent of Kolodny and PROP’s relationship with the CDC, because the agency has refused to disclose key material about its guideline deliberations. The CDC’s response to a Freedom of Information Act (FOIA) request from PNN was to send us nearly 1,500 pages of documents that were heavily redacted or scrubbed of information. Over 1,200 pages were completely blank, including some of the conflict of interest statements of CDC advisors like Kolodny.

The agency cited “deliberative process privilege” and “personal privacy” as reasons to withhold the information

(Update: In 2022 testimony in West Virginia, Kolodny testified that he started working on opioid litigation in 2012 with Linda Singer from the law firm Cohen Milstein. It’s unknown if he disclosed that relationship to the CDC on his conflict of interest statement. In 2017, Singer joined Motley Rice, yet another law firm involved in opioid litigation.) .

Friendly Questions

Kolodny took only a handful of friendly, softball questions during the PharmedOut webinar, most of them from students at Georgetown University who are interning at PharmedOut. Several pain patients also submitted more critical questions, but they were not passed on to Kolodny.

Although opioid prescriptions in the U.S. have been declining since their peak in 2011, Kolodny says they need to go down further, even though nearly 85% of overdose deaths in the U.S. involve illicit fentanyl and other street drugs.

“We continue to massively overprescribe,” he said. “Opioids are not good treatments for chronic pain. It’s not true that more cautious prescribing somehow jeopardizes compassionate care for chronic pain. Compassionate care for chronic pain really demands more cautious prescribing.”

Kolodny is quick to blame “industry funded groups” for opposition to the CDC guideline, but PROP has remained secretive about its own funding. PROP uses a loophole in IRS regulations that allows it to hide behind front organizations such as the Steve Rummler Hope Network as its “fiscal sponsor.” Because it is not registered as a nonprofit — although it sometimes claims to be one — PROP has never filed a federal or state tax return and is not required to disclose anything about its funding or spending.

Kolodny currently works in opioid research at Brandeis University, but has a lucrative sideline testifying as an expert witness in opioid litigation and malpractice lawsuits. He was paid $725 an hour for his testimony during Oklahoma’s lawsuit against Johnson & Johnson, and may have collected as much as $500,000 for that case alone.

Dr. Adriane Fugh-Berman, who is a PROP board member and Director of PharmedOut, is also a paid expert witness and earned $500 an hour for her testimony in another trial involving Johnson & Johnson. She reportedly received about $120,000 for her work in that case. Like PROP, PharmedOut does not disclose its funding or donors.

Doctors Advised Not To Prescribe Cannabis for Chronic Pain

By Pat Anson, PNN Editors

Pain management experts around the world are becoming more vocal about the growing use of medical marijuana as a treatment for chronic pain, saying there is little evidence to support the use of cannabis as an analgesic.

Today the Faculty of Pain Medicine at the Australian and New Zealand College of Anaesthetists (ANZCA) released new guidance urging doctors not to prescribe medical cannabis for patients with chronic, non-cancer pain unless they are enrolled in a clinical trial.

“Until there are results from high-quality, unbiased clinical trials which establish the effectiveness and safety of medicinal cannabis in treating chronic pain, the Faculty of Pain Medicine does not believe cannabinoid products should be prescribed,” Mick Vagg, MD, Dean of the Faculty of Pain Medicine, said in a statement.  

“We want to highlight to healthcare providers that currently available medical cannabis products are not even close at this stage to showing that they deserve a place in the management of the complex patients who suffer from ongoing pain. We believe clinicians will welcome this clear guidance.”

ANZCA is a professional society for nearly 8,000 anesthesiologists and pain management specialists in Australia and New Zealand, and sets standards for pain medicine in both countries.

Australia and New Zealand have some of the highest rates of cannabis consumption in the world. But New Zealand only allows medical cannabis for terminally ill patients, while Australia requires a prescription for cannabis that is often difficult to obtain.

About one if five Australians live with chronic pain.   

“Medical cannabis products are not even close at this stage to showing that they deserve a place in the management of the complex patients who suffer from ongoing pain.”

— Dr. Mick Vagg

“By far the most common reason for the use of medicinal cannabis in this country is chronic pain − however there is a critical lack of evidence that it provides a consistent benefit for any type of chronic non-cancer pain, especially compared to the treatments we already strive to provide in pain clinics,” Vagg said.

“The research available is either unsupportive of using cannabinoid products in chronic non-cancer pain or is of such low quality that no valid scientific conclusion can be drawn. Cannabidiol-only formulations have never been the subject of a published randomised controlled trial for chronic pain treatment, yet they are the most commonly prescribed type of cannabis product.”

Vagg also said research is lacking in how cannabinoids react with pharmaceutical drugs, particularly in relation to their sedative and psychiatric side effects.

‘Hypothesis’ of Analgesia

ANZCA’s new guidance came just days after the International Association for the Study of Pain (IASP) released a position statement saying it could not endorse the use of cannabinoids to treat pain. IASP said there were preliminary studies supporting the “hypothesis of cannabinoid analgesia,” but not enough to overcome the lack of evidence on the safety and efficacy of cannabinoids.

“While IASP cannot endorse the general use of cannabinoids for treatment of pain at this time, we do not wish to dismiss the lived experiences of people with pain who have found benefit from their use,” said Andrew Rice, MD, chair of IASP’s Presidential Task Force on Cannabis and Cannabinoid Analgesia.

“This is not a door closing on the topic, but rather a call for more rigorous and robust research to better understand any potential benefits and harms related to the possible use of medical cannabis, cannabis-based medicines and synthetic cannabinoids for pain relief, and to ensure the safety of patients and the public through regulatory standards and safeguards.”

Rice said IASP was concerned that laws allowing the use of medical marijuana were being adopted without the same rigor and regulatory procedures that are followed for pharmaceutical products. Patients who self-treat their pain with cannabis are also at risk, according to Rice, because their doctors often don’t know about their cannabis use.  

“IASP is also calling for the delivery of a comprehensive research agenda. Priorities include identifying patients with pain who may receive the most benefit from cannabis or cannabinoids, and who may be at risk of the most harm,” said former IASP president Lars Arendt-Nielsen, MD, who co-chaired the Cannabis Task Force.

Supporters of medical cannabis dispute the contention that there is inadequate evidence about the use of cannabis for pain.

“These recommendations are political, not scientific. Several peer-reviewed trials have concluded that inhaled cannabis is safe and effective for treating various types of pain, in particular neuropathic pain,” Paul Armentano, Deputy Director of NORML, said in an email to PNN.

Armentano cited a 2017 study from the U.S. National Academy of Sciences, which found “conclusive or substantial evidence” that cannabis is an effective treatment for chronic pain.

“In the real world, the therapeutic use of cannabis is rising among chronic pain patients, many of whom are substituting it in place of opioids. In jurisdictions where cannabis is legally available, chronic pain is the most qualifying condition among medical cannabis patients enrolled in state-specific access programs. To willfully ignore these data is indicative that political considerations, rather than scientific considerations, influenced this group’s decision,” Armentano said.

Injections of Tiny Particles Reduce Osteoarthritis Knee Pain

By Pat Anson, PNN Editor

A minimally invasive procedure significantly reduces pain and inflammation caused by knee osteoarthritis, according to preliminary research being presented this week at the annual meeting of the Society of Interventional Radiology.

Geniculate artery embolization (GAE) is a relatively new procedure in which thousands of microscopic particles are injected into arthritic knees. The particles reduce inflammation by disrupting the abnormal flow of blood caused by osteoarthritis (OA), a joint disorder that causes thinning of cartilage and progressive joint damage. As the cartilage breaks down, it releases enzymes that cause inflammation and pain.

GAE takes about one to two hours, and many patients with knee OA report significant improvement in pain and physical function that can last up to a year.

"Prior to treatment, patients' knee pain had taken over their whole life," said lead researcher Siddharth Padia, MD, a professor of radiology at UCLA Health. "But after treatment, patients who initially could walk only three or four blocks were walking three miles. Some were able to do away with walking aids, such as canes, while others reported being in a better mood now that they were living without pain."

For their Phase 2 study, Padia and his colleagues enrolled 40 patients with knee OA who were not candidates for total knee replacement, and who failed to benefit from pain relievers, joint injections and physical therapy.

Catheters were inserted into arteries leading to the knees through pinhole incisions in the patients’ hips. The microscopic particles — called Embozene microspheres — were then slowly injected through the catheter into the knees. Each patient was evaluated for pain and adverse events at one week; one, three and six months; and one year after the treatment.

Researchers say patients saw benefits as soon as three days after the procedure. Average pain levels decreased from 8 out of 10 before GAE to 3 out of 10 within the first week. Most patients reported more than 50% reduction in their pain levels at the one-year follow up.

Adverse events, such as skin ulceration and small bone infarction – the death of bone tissue due to reduced blood supply -- were reported by 9 patients, but resolved without treatment.

Embozene microspheres are made by Boston Scientific and are currently used in the treatment of vascular tumors, uterine fibroids and arterial malformations. They must be carefully injected into affected tissue to prevent them from circulating in the blood and reaching healthy tissue and organs.

“This prospective trial demonstrates that GAE is highly effective and durable in reducing symptoms due to moderate to severe knee OA that is refractory to other conservative therapy, and has an acceptably low toxicity profile,” researchers concluded.

The UCLA researchers plan to conduct a larger, randomized trial to determine which patients may benefit most from GAE and the impact it has on slowing the progression of arthritis.

Results from other studies on the use of GAE are also being presented at the meeting of the Society of Interventional Radiology. One review found that GAE can be effective for patients who don't respond well to conservative treatments for knee OA, but cautioned that “definitive conclusions can't be made on the true efficacy of GAE until studies are done with longer follow up and larger patient numbers.”