A Survey for Canadian Pain Patients

By Ann Marie Gaudon, PNN Columnist

The last few years have been very difficult for pain patients in Canada. If you are one of the severely pained, you well know that government officials, in a misguided attempt to deal with the problems of addiction and overdose deaths, decided that doctors have been over-prescribing opioid medications and that pain patients taking opioid therapy were the cause of the problems.

The Chronic Pain Association of Canada (CPAC) knows this was never true.

Given the fact that overdose deaths continue to increase as opioid prescriptions have been drastically reduced, government policy has been a total failure while causing tremendous harm to innocent victims.

As a volunteer for CPAC, I want to let you know that our goal is to educate the public, people in medicine, regulatory bodies, and Health Canada on the nature and severity of chronic pain and its treatment. We are working hard behind the scenes to spread awareness with the correct information. No hype, no hysteria – just the facts.

CPAC has created an anonymous survey for Canadians needing opioid medication for pain treatment. We are running out of time and need your help.

The survey is designed to gain a snapshot of how your medical care has unfolded over the past couple of years and how this has affected your overall health. It will take approximately 5 to 10 minutes to complete.

If you are a Canadian pain patient in need of opioid medicines or a caretaker of same, this survey is for you. Please share it widely.

This survey is anonymous: we will not collect personal information, your email address or your computer's IP address.

Once we have collected the data, it will be shared with Health Canada, other government health officials, the media, and all of our allies. If you are not on our emailing list, please join us here.

The time is NOW for your valuable input. Take and/or share the survey by clicking clicking here.

Thank you for helping Canada’s only national advocate for pain patients. We can’t do it without you!

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Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for over 30 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website.

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

Use of NSAIDs Risky for Osteoarthritis Patients

By Pat Anson, PNN Editor

It’s long been known that nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen can raise the risk of cardiovascular problems. A large new study in Canada has documented how NSAIDs can significantly raise the risk of heart disease, congestive heart failure and stroke in people with osteoarthritis.

Osteoarthritis (OA) is a joint disorder that leads to thinning of cartilage and progressive joint damage. NSAIDs are frequently used to treat the pain and inflammation caused by OA.

The Canadian study, published in the journal Arthritis & Rheumatology, looked at nearly 7,750 osteoarthritis patients in British Columbia and compared them with a control group of over 23,000 patients without OA. The average age of the participants was 65 and a little over half were women.

The risk of developing cardiovascular disease was found to be about 23% higher among people with OA than the control group. Researchers attributed about 41% of that increased risk to the use of NSAIDs.

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NSAIDs appeared to play a significant role in several cardiovascular problems. The risk of congestive heart failure was 42% higher among people with OA, followed by a 17% greater risk of heart disease and a 14% greater risk of stroke.

"To the best of our knowledge, this is the first longitudinal study to evaluate the mediating role of NSAID use in the relationship between osteoarthritis and cardiovascular disease in a large population-based sample," said senior author Aslam Anis, PhD, of the School of Population and Public Health at the University of British Columbia.

"Our results indicate that osteoarthritis is an independent risk factor for cardiovascular disease and suggest a substantial proportion of the increased risk is due to the use of NSAIDs. This is highly relevant because NSAIDs are some of the most commonly used drugs to manage pain in patients with osteoarthritis."

The association of cardiovascular disease with NSAIDs is consistent with previous research.  A large international study in 2017, for example, found that prescription strength NSAIDs raises the risk of a heart attack as soon as the first week of use.

NSAIDs are used to alleviate pain and reduce inflammation, and are found in a wide variety of over-the-counter products, including cold and flu remedies. They are found in so many products -- such as Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

Canada adopted guidelines in 2017 that recommend NSAIDs as an alternative to opioid pain medication. The guideline makes no mention of the health risks associated with NSAIDs, but focuses on their cost effectiveness.

“NSAID-based treatment may have lower mean costs and higher effectiveness relative to opioids,” the guideline states. “Naproxen-based regimens in particular may be more cost effective compared to opioids and other NSAIDs, such as ibuprofen and celecoxib.”

Opioid guidelines released in 2016 by the U.S. Centers for Disease Control and Prevention also recommend NSAIDs as an alternative to opioids, but acknowledge the medications “do have risks, including gastrointestinal bleeding or perforation as well as renal and cardiovascular risks.”

In 2015, the Food and Drug Administration ordered warning labels for all NSAIDs to indicate they increase the risk of a fatal heart attack or stroke. The FDA warning does not apply to aspirin.

The European Society of Cardiology recommends limited use of NSAIDs by patients who are at risk of heart failure. People already diagnosed with heart failure should refrain from using NSAIDs altogether.

A Pained Life: We Need More Than Opioids

By Carol Levy, PNN Columnist

There is no question we need to be active and stay on top of what the CDC and other federal agencies are doing that impedes our ability to get opioid medication.  For many chronic pain patients, opioids are the only effective pain reliever.

I wonder though: In focusing almost all of our energies on the issue of opioids, are we ignoring another front that needs to be addressed?

Cancer seems like the best analogy to me, maybe the only one. There are many forms of cancer but at the end of the day they all involve the excessive growth of cells that spread into surrounding tissue. All cancers, to my knowledge, start from that one errant misfire.

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In recent years we have seen cancer treatments change and become more specific -- this combination of chemotherapy for lung cancer, a different type of chemo for sarcoma or leukemia, and so on. But ultimately, they are all some form of chemotherapy.

Unlike cancer, we can’t put all of our eggs into one basket. There is no universal type of “chronic pain.” We need to have different treatments and regimens for each pain disorder.

Trigeminal neuralgia and other cranial neuropathies have a different cause and mechanism than rheumatoid arthritis and other autoimmune diseases. So do multiple sclerosis and arachnoiditis.  Conditions like fibromyalgia and Chronic Regional Pain Syndrome (CRPS) are still poorly understood and difficult to treat.

Unlike cancer, we need to have multiple approaches to chronic pain syndromes. No one has come up with anything better than opioids for pain control and relief – at least not yet -- so this choice must remain accessible. But we must also not lose sight of the need for better treatments and possibly even cures for every pain condition.

We have to let it be known that we need opioids, not because they make us high, but because there is nothing else out there to take their place.  It is well past time for the government to understand, if they want to end the use of opioids, they must first ensure that there are other viable options out there.

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Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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

CDC: Still Not Enough Naloxone   

By Pat Anson, PNN Editor

The Trump Administration is stepping up efforts to increase prescribing of naloxone, an overdose recovery drug credited with saving thousands of lives.

Although naloxone prescriptions have increased dramatically, a new CDC Vital Signs report estimates that nearly 9 million additional prescriptions could have been dispensed last year if every patient with a high-dose opioid prescription was offered naloxone.  Patients are considered “high risk” if they take an opioid dose of 50 morphine milligram equivalent (MME) or more per day.

Naloxone has been used for years by first responders and emergency medical providers to revive overdose victims. Current efforts are focused on expanding access to the drug by prescribing it directly to patients considered at risk of an overdose.

In 2018, CDC researchers say only one naloxone prescription was dispensed for every 70 high-dose opioid prescriptions nationwide. Naloxone “under-prescribing” was even more acute in rural counties, which are nearly three times more likely to be ranked low in naloxone dispensing than metropolitan counties.

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“It is clear from the data that there is still much needed education around the important role naloxone plays in reducing overdose deaths. The time is now to ensure all individuals who are prescribed high-dose opioids also receive naloxone as a potential life-saving intervention,” CDC Director Robert Redfield, MD, said in a statement.

Ironically, federal policies contribute to the under-prescribing. In 2018, most (71%) Medicare prescriptions for naloxone required a copay, compared to 42% for commercial insurance.

In January, the Food and Drug Administration encouraged drug makers to make naloxone available over-the-counter without a prescription. The FDA even developed an OTC label for Narcan, a naloxone nasal spray that sells for about $135. Seven months later, the FDA could not confirm to PNN that any company had submitted an application for an OTC version of naloxone.

Last year the Department of Health and Human Services released guidance urging doctors to “strongly consider” prescribing naloxone to patients on any dose of opioids when they also have respiratory conditions or obstructive sleep apnea, are co-prescribed benzodiazepines, have a mental health or substance abuse disorder, or a history of illegal drug use or prescription opioid misuse.

Many states are also taking steps to increase naloxone prescribing. California now requires doctors to “offer” naloxone prescriptions to pain patients deemed at high risk of an overdose. State law does not make the prescriptions mandatory, yet some patients say they were “blackmailed” by pharmacists who refused to fill their opioid scripts unless naloxone was also purchased. Patients around the country report similar experiences.   

Unintended Consequences

The drumbeat for naloxone comes at a time when sales are already booming. There were 556,000 naloxone prescriptions in 2018, twice as many as in 2017.

There’s no doubt naloxone saves lives, but some researchers say the drug has had little effect on the overdose crisis and may in fact be making it worse. In a recent study published by SSRN, two economics professors warned of “unintended consequences” if naloxone becomes more widely available.

“We expect these unintended consequences to occur through two channels. First, the reduced risk of death makes opioid abuse more appealing, leading some to increase their opioid use — or use more potent forms of the drug — when they have naloxone as a safety net. Some of those abusers may become criminally active to fund their increased drug use,” wrote Jennifer Doleac, PhD, Texas A&M University, and co-author Anita Mukherjee, PhD, University of Wisconsin.

“Furthermore, expanding naloxone access might not in fact reduce mortality. Though the risk of death per opioid use falls, an increase in the number or potency of uses means the expected effect on mortality is ambiguous.”

The researchers said there were anecdotal reports of “naloxone parties” where attendees used heroin and prescription opioids to get high knowing they could be revived. News reports have also quoted first responders who are frustrated that the same opioid abusers “are saved again and again by naloxone without getting treatment.”

Co-Pay Assistance Programs Fail to Help Uninsured Patients

By Pat Anson, PNN Editor

Co-pay assistance programs – also known as co-pay charities – are ostensibly designed to help needy patients pay for prescription drugs. But a new study by researchers at the Johns Hopkins Bloomberg School of Public Health found that nearly all co-pay programs fail to cover uninsured patients who need financial help the most.

The researchers also found that co-pay programs were more likely to cover high-cost, brand-name prescription drugs, despite the availability of lower-priced generic medications. The findings are published online in JAMA.

“Independent patient assistance programs favor higher-priced drugs, and the higher the drug price, the higher the likelihood of it being covered,” says co-author Gerard Anderson, PhD, professor in the Bloomberg School’s Department of Health Policy and Management. “Unfortunately patients with the greatest financial needs -- people without health insurance -- do not qualify for these programs.”

Anderson and his colleagues looked at the six largest charity organizations, which ran 274 different patient assistance programs in 2018.

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Most of the programs only covered drugs for cancer-related conditions or genetic and rare diseases. None offered free drugs and typically they only covered the most expensive medications.

“Only covering insured patients may help these programs cover more patients with their limited funds,” said lead author So-Yeon Kang, MPH, a research assistant in the Bloomberg School’s Department of Health Policy and Management. “But leaving out the uninsured diminishes the charitable aspects of these organizations supported by tax-exempted donations.”

Misconduct Widespread

Patient assistance programs run by independent charities are usually funded by pharmaceutical companies. Federal investigations into several co-pay assistance programs led to multimillion-dollar settlements with drug companies for allegedly steering patients to their higher-priced drugs.

Over the past year, Pfizer, Amgen, Jazz Pharmaceuticals, Astellas Pharma, Lundbeck and Alexion have all paid heavy fines to settle allegations that they used co-pay programs to defraud Medicare. Federal anti-kickback laws prohibit pharmaceutical companies from making any kind of payment to induce Medicare patients to purchase their drugs. The prohibition includes co-pays.

“We are committed to ensuring that pharmaceutical companies do not use third-party foundations to pay kickbacks masking the high prices those companies charge for their drugs,”  U.S. Attorney Andrew Lelling said in a statement. “This misconduct is widespread, and enforcement will continue until pharmaceutical companies stop circumventing the anti-kickback laws to artificially bolster high drug prices, all at the expense of American taxpayers.”

Similar allegations were made against Insys Therapeutics and the “Gain Against Pain” co-pay program run by the U.S. Pain Foundation. Insys donated over $3.1 million to U.S. Pain, with most of the money going to its co-pay program to help patients pay for Subsys, an expensive fentanyl spray made by Insys. A four-day supply of Subsys can cost nearly $24,000.

The founder of Insys and four former executives were recently found guilty of racketeering charges unrelated to the co-pay program. The company also agreed to pay $225 million in fines and penalties to settle criminal and civil investigations. U.S. Pain ended the “Gain Against Pain” program in 2018 and said it would no longer accept funding from Insys.

In an editorial, Katherine Kraschel, a lecturer at Yale Law School, and Gregory Curfman, MD, deputy editor of JAMA, called for more oversight of co-pay programs to make sure they help patients who truly need it.

“Although patient assistance programs may provide important financial relief for patients, the current patient assistance program structure largely neglects uninsured individuals,” they wrote.  “Absent other regulatory interventions, the Department of Justice needs to continue to scrutinize patient assistance program practices, and the Internal Revenue Service and state attorneys general should examine the tax-exempt status of patient assistance programs.”

Professional Athletes Get Stem Cell Therapy, But Should You?

By Liz Szabo, Kaiser Health News

Baseball superstar Max Scherzer — whose back injury has prevented him from pitching for the Washington Nationals since he last played on July 25 — is the latest in a long list of professional athletes to embrace stem cell injections in an attempt to accelerate their recovery.

But many doctors and ethicists worry that pro athletes — who have played a key role in popularizing stem cells — are misleading the public into thinking that the costly, controversial shots are an accepted, approved treatment.

“It sends a signal to all the fans out there that stem cells have more value than they really do,” said Dr. James Rickert, president of the Society for Patient Centered Orthopedics, which advocates for high-quality care. “It’s extremely good PR for the people selling this kind of thing. But there’s no question that this is an unproven treatment.”

Stem cells and related therapies, such as platelet injections, have been used for the past decade by top athletes: golfer Tiger Woods, tennis pro Rafael Nadal, hockey legend Gordie Howe, basketball player Kobe Bryant and NFL quarterback Peyton Manning. Stem cells are offered at roughly 1,000 clinics nationwide, as well as at some of the country’s most respected hospitals.

Depending on the treatment, the cost can range from hundreds to thousands of dollars. Insurance does not cover the treatments in most cases, so patients pay out of pocket.

Yet for all the hype, there’s no proof it works, said Paul Knoepfler, a professor in the department of cell biology and human anatomy at the University of California at Davis.

By    Arturo Pardavila III     from Hoboken, NJ, USA

By Arturo Pardavila III from Hoboken, NJ, USA

Referring to Scherzer, Knoepfler said, “There’s really not much evidence that it’s going to help him, other than as a psychological boost or as a placebo effect.”

Scherzer, 35, said he received a stem cell shot Friday for a mild strain in his upper back and shoulder. According to a news story on the Major League Baseball website, Scherzer also previously had a stem cell injection to treat a thumb injury.

If the diagnosis of Scherzer’s mild muscle strain is correct, it should completely heal itself with 10 days of rest, Rickert said, so Scherzer would probably feel ready to play by Monday even without the stem cells. But Rickert said he worries about other athletes who are tempted to return to the field too soon.

“The risk from the stem cell procedure is that it could give someone a false sense of confidence, and they could go back to play too early” and reinjure themselves, he said.

A spokeswoman for the Washington Nationals declined to provide information about Scherzer’s treatment, such as the type of stem cells used or the name of the clinician who administered them.

Clinics that offer stem cell treatments prepare injections by withdrawing a person’s fat or bone marrow, then processing the cells and injecting them back into aching joints, tendons or muscles.

Another popular treatment involves concentrating platelets — the cells that help blood clot. Many people confuse platelet injections with stem cell injections, perhaps because the shots are promoted as treatments for similar conditions, said Dr. Kelly Scollon-Grieve, a physical medicine and rehabilitation specialist at Premier Orthopaedics in Havertown, Pa.

Placebo Effect on Pain

When it comes to pain, injections can act as powerful placebos, partly because suffering patients put so much faith in treatment, said Dr. Nicholas DiNubile, an orthopedic surgeon and former consultant for the Philadelphia 76ers.

In a recent analysis, more than 80% of patients with knee arthritis perceived a noticeable improvement in pain after receiving a placebo of simple saline shots.

Team doctors often treat athletes with a variety of therapies, in the hope of getting them quickly back on the field, said Arthur Caplan, director of the division of medical ethics at New York University School of Medicine. Athletes may assume that stem cells are responsible for their recovery, when the real credit should go to other remedies, such as ice, heat, nonsteroidal anti-inflammatory medications, cortisone shots, massage, physical therapy or simple rest.

“These are the richest, most highly paid athletes around,” Caplan said. (Scherzer and the Nats agreed to a $210 million, seven-year contract in 2015.) “So anything you can think of, they’re getting. But I wouldn’t use them as a role model for how to treat injuries.”

While athletes often talk about their stem cell treatments, Caplan said he wonders, “Would the inflammation or problem have just gone away on its own?”

Sports fans shouldn’t expect to have the same reaction to stem cells — or any medical intervention — as a professional athlete, DiNubile said.

In general, athletes recover far more rapidly than other people, just because they’re so young and fit, DiNubile said. The genes and training that propelled them to the major leagues may also aid in their recovery. “They have access to the best care, night and day,” DiNubile said.

Whenever a top athlete is treated with stem cells, word spreads quickly on social media. Fans often end up doing the stem cell industry’s marketing for them: A 2015 analysis found that 72% of tweets about Gordie Howe’s stem cell treatments were positive. Of 2,783 tweets studied, only one mentioned that Howe’s treatment, delivered in Mexico after Howe’s stroke, was unproved and not approved by the U.S. Food and Drug Administration. Howe died in 2016.

The Mexican stem cell clinic provided Howe’s treatment at no charge. Clinics use such donations as a form of marketing, because they generate priceless publicity, said Leigh Turner, an associate professor at the University of Minnesota’s Center for Bioethics who has published articles describing the size and dynamics of the stem cell market.

“Clinics provide free stem cell treatments or offer procedures at a discounted rate, and in return they can generate YouTube testimonials, press releases and positive media coverage,” Turner said. “It’s also a good way to build relationships with wealthy individuals and get them to refer friends and family members for stem cell procedures.”

Stem cell clinics often feature athletes and other celebrities on their websites and in marketing materials.

In a 2018 column, Los Angeles Times writer Michael Hiltzik noted that stem cell treatment has failed three baseball players with the Los Angeles Angels. Players Shohei Ohtani, Andrew Heaney and Garrett Richards, who is no longer with the Angels, tried stem cells in the past three years in an effort to avoid surgery. All ended up needing surgery anyway.

As DiNubile said, “the marketing is clearly ahead of the science, no question.”

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

Would Decriminalization Solve the Overdose Crisis?

By Pat Anson, PNN Editor

Vancouver, British Columbia was the first major North American city to be hit by the overdose crisis. In 2016, after a wave of overdose deaths involving illicit fentanyl and even more deadly synthetic opioids like carfentanil, the western Canadian province declared a public health emergency.

Despite efforts to decrease the supply of prescription opioids in BC, over 3,600 more people have overdosed since the emergency was declared, with fentanyl detected in 87% of the deaths last year.

So when BC’s largest healthcare system recommends some radical solutions to the overdose crisis, it’s worth noting. Vancouver Coastal Health (VCH) released a report last month recommending that illegal drugs be decriminalized and that drug users be given access to prescription opioids as an alternative to the black market.

"Legalization and regulation of all psychoactive substances would reduce people's dependence on the toxic illegal supply, criminal drug trafficking and illegal activities that people with addictions must engage in to finance their drug use," said Dr. Patricia Daly, VCH’s chief medical health officer.  

Some Canadian drug policy experts think the idea makes sense.

"The illegal market is an absolute toxic mess right now," Donald MacPherson, executive director of the Canadian Drug Policy Coalition, told the CBC. "It's really in line with consumer protection strategy ... just like we do with every other substance that we ingest, whether it be food or drugs."

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Also notable about the VCH report is that – unlike most regulators and politicians in Canada and the U.S. – prescription opioids are not singled out as the root cause of the overdose crisis. Instead, opioid medication is seen as part of the solution.

The report recommends pilot programs to see if prescription fentanyl and other opioid medications made available at supervised consumption sites could help high-risk illicit drug users “transition” to legal opioids.

“Piloting legal access to opioids is different from OAT (opioid agonist therapy) as treatment and would be low-barrier and flexible. Initial pilots would include observation of consumption, followed by pilots allowing distribution of opioids for people to take away for later consumption,” the report recommends.

The idea is controversial, but some doctors are warming up to it. A pilot program recently began at a Vancouver clinic, where hydromorphone tablets are given to about 50 patients who ingest them on site under staff supervision. In Ontario, over 400 healthcare providers and researchers recently signed an open letter asking that high dose injectable hydromorphone be made widely available to illicit drug users.

Substance Abuse and Socioeconomic Problems

The primary cause of the opioid crisis, according to the VCH report, is a “complex interaction” of socioeconomic problems, such as unemployment and homelessness, combined with substance abuse and an increasingly dangerous black market supply.

VCH analyzed the deaths of 424 overdose victims from 2017 and found that less than half (45%) even sought treatment for acute or chronic pain. They were far more likely to be unemployed (72%) and have a substance abuse problem (84%). About four out of ten overdose victims used opioids, alcohol or stimulants daily.

“Most of those who died used multiple substances including opioids, alcohol and stimulants such as cocaine and crystal meth. A significant percentage of those who died of opioid overdoses had primary alcohol use disorder and/or stimulant use disorder,” the report found.

Importantly, most of those who died were no strangers to the healthcare system. The vast majority (77%) had seen a healthcare provider in the year before they overdosed and one out of five (21%) had seen a provider a week before their death. Six out of ten (59%) had received Suboxone or methadone to treat opioid addiction, but the medications were either not effective or they dropped out of treatment.

In addition to decriminalization, the VCH report recommends improving access to addiction treatment, better substance abuse training of healthcare providers, and increased access to the overdose reversal drug naloxone.