What Pain Patients Can Learn from JFK

By Crystal Lindell, Columnist

I’ve recently become kind of obsessed with the fact John F. Kennedy had health issues. Like major health issues. Like Addison’s disease, ulcers, colitis, and back pain issues, among others.

It’s one of the few things most people don’t seem to know about JFK. He was sick. Really sick. And he was often dealing with his health while running the country.

The Atlantic detailed some of Kennedy’s health issues in “The Medical Ordeals of JFK” back in 2013. They talked about how while JFK was in the White House he routinely saw an allergist, an endocrinologist, a gastroenterologist, an orthopedist and an urologist. JFK also regularly took amphetamines and had painkillers injected into his back.

In other words, he went through the same things a lot of us with chronic pain go through. Except, you know, he managed to run the Free World between steroid injections.

There’s a part of me that wishes he hadn’t hid his aliments. The article details how his campaign flat-out denied he had Addison’s disease. The day after his election, in response to a reporter’s question, JFK “declared himself in ‘excellent’ shape and dismissed the rumors of Addison’s disease as false.”

Personally, I had no idea that JFK struggled with so many health issues until I stumbled upon the information while researching chronic pain. And from what I can tell, most people in America don’t realize just how sick he was either.

I can’t help but wonder what he may have been able to do for the stigma associated with chronic illness if he had ever admitted to his aliments publicly though. Imagine if the stereotype of someone with chronic illness was JFK.  Sure, it’s a lot to live up to, but it’s better than what we face now, which is usually something along the lines of, “a lazy, druggie who probably brought it on themselves.”

And maybe he could have even helped people understand that cancer isn’t the only bad thing that can happen to you. And that sometimes, you don’t get better and you don’t die — you just stay sick.

But, there’s probably a good chance he would have never been elected if the American public knew he was seeing Max Jacobson, an émigré doctor from Germany who had made a reputation treating celebrities with “pep pills” (amphetamines).

The thing that really strikes me though is just how much JFK was able to accomplish despite his health. Most days, I’m in too much pain to drive to the grocery store, much less run for president.

From what I’ve read, it seems as though JKF was totally cool with popping as many pills as he needed to in order to keep going. As The Atlantic details, “[He didn’t] believe that the many medications he took would reduce his ability to work effectively; on the contrary, he saw them as ensuring his competence to deal with the demands of the office.”

In other words, he was all for medication if it meant he would be able to endure a press conference.

And I’m also guessing he was the type of sick person who had access to any and all medications that he thought would help him. Something most of us can only dream of.

There was definitely a point in my life when I would have loved taking hundreds of Norco each month so that I could have kept pace with my previous lifestyle. I mean, I probably wouldn’t have a liver anymore, but at least I’d still have my own apartment.

Even on my current doses, my main reason for taking drugs is so that I can do as much as possible. Sometimes that means a work trip to Arizona, and other times it means having the strength to sit up on the couch and type out a column.

So I can completely understand why JFK felt like he did about the pills. But I don’t think most people would.

Heck, the number one comment I get from anyone who finds out how many drugs I take on the daily is, “You need to get off all those medications.” I usually explain that if I “got off all those medications” then I also wouldn’t be able to get off the couch. 

I also assume that when JFK said he was in pain, at least one of the like 23 specialists he was seeing believed him and responded accordingly. Again, something most of us can only dream of.

He also probably had no issues paying for his medications or getting to doctors’ appointments. And I’m sure he was able to see the very best doctors in the country whenever he wanted.

Even knowing that he had all sorts of advantages as a sick person though, there’s still a huge part of me that feels really inadequate thinking about how much JFK got done. I mean, I have literally had to scale back every aspect of my life since getting sick. I quit my side job as a youth leader, which I loved with all my heart. I moved in with my mom. I started working from home. And I even stopped going to the mall as much as I used to.

For me, a big part of being sick has been losing so many of the things I love, and then figuring out how to cope with those losses.

But then, there’s another part of me that thinks of JFK and is kind of inspired. Maybe there is hope for me yet. Maybe I can still live in Brazil one day, or become a best-selling author, or heck, run for office just like JFK did. 

I just need to find that German doctor and get some of those “pep pills.”

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

Fed Report Sparks New Debate over Steroid Injections

By Pat Anson, Editor

A government report on epidural steroid injections is sparking a new debate on the safety and effectiveness of the procedure, which is used to treat back pain in millions of people.

A coalition of spine and pain management doctors is calling the report’s conclusion that steroid injections have little value  “fundamentally false.”

But critics of the procedure say the injections are risky, overused, and often a waste of money.

The report by the Agency for Healthcare Research and Quality (AHRQ), which is part of the Department of Health and Human Services, said there is little evidence that epidural steroid injections were effective in treating low back pain.

“Epidural corticosteroid injections for radiculopathy were associated with immediate improvements in pain and might be associated with immediate improvements in function, but benefits were small and not sustained, and there was no effect on long-term risk of surgery,” the report states.

Epidural injections have been used for many years to relieve pain during childbirth, but they are increasingly being used to treat back pain.

An estimated 9 million epidural steroid injections are performed in the U.S. annually, and the shots have become a common procedure at many pain management clinics. Costs vary from as little as $445 to $2,000 per injection.

A coalition of 14 different societies representing anesthesiologists, surgeons and pain management doctors is lobbying the AHRQ to tone down its report, saying it has raised “significant concerns for physicians who utilize injection procedures.”

“We are fully cognizant of the issues of overutilization and inappropriate utilization, and therefore also wish to bring into focus which interventions are effective when treating the various causes of back pain,” wrote Belinda Duszynski, senior director of Policy and Practice for the International Spine Society, in a lengthy letter to the AHRQ on behalf of the Multisociety Pain Workgroup.

Duszynski’s letter, which is also being sent to a number of medical journals, claims the authors of the AHRQ report used “flawed” and “absurd” analysis on the effectiveness of the injections. She warned the report “may lead to egregious denial of access to these procedures for many patients suffering from low back pain.”

But critics say "interventionalist" doctors are simply trying to preserve a lucrative part of their practice.

“These professional medical societies are worked up because this study basically states that epidural steroid injections have small benefit, the improvements in function are not sustained, and they do not prevent surgery,” said Terri Anderson, a Montana woman whose spine was permanently damaged after receiving about 20 steroid injections for a ruptured disc in her back.

Anderson now suffers from arachnoiditis, an inflammation in the spinal membrane that causes severe chronic pain and disability.

“From my personal perspective, these spinal injections are wasting billions of dollars on the front end, plus there is no estimate high enough to account for the human suffering that this industry has brought upon the American public,” Anderson wrote in an email to Pain News Network.  “When the injections go south and the steroids are misplaced in the spinal cord, this results in life-long disabilities and suffering that cannot be described.” 

The AHRQ report is not the first to raise questions about the safety and effectiveness of epidural steroid injections. Several recent studies have found the injections raise the risk of spinal fractures and do little to control back pain. Questions about their safety also led to an order from the Food and Drug Administration last year that requires drug makers to put warning labels on injectable steroids.

“Injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death,” the FDA said in a statement.

The agency has never formally approved the use of steroid injections to treat back pain. However, the procedure can still be used “off label” to treat back pain.

Many patients who were injured by spinal injections say they were never warned about the risks involved.

“The fact of the matter remains that there is no solid evidence that these injections are of any lasting benefit,” said Dawn Gonzalez, who developed arachnoiditis after a botched epidural during childbirth. “There is just no sound supporting evidence of the efficacy of corticosteroid injections in the spine, and more evidence of the contrary. Epidural steroid injections are bad science.”

A study funded by the AHRQ and published last year in the New England Journal of Medicine found that epidural steroid injections do not relieve pain in patients with lumbar spinal stenosis, a common cause of lower back and leg pain.

The Choosing Wisely campaign of the ABIM Foundation, which seeks to reduce or eliminate unnecessary medical procedures, does not oppose the use of steroid injections for back pain. But it does urge doctors not to repeat the procedure if a patient shows no improvement from a previous injection. 

Lower back pain is the world's leading cause of disability, causing more health loss than diabetes, chronic obstructive pulmonary disease, and asthma combined. Over 80 percent of adults have low back pain at some point in their lives.

Sedatives or Opioids: Which is the Bigger Problem?

By Pat Anson, Editor

New research shows that the prescribing of opioid pain medications is declining in United States, but the co-prescribing of sedatives with opioids remains a serious problem that raises the risk of an overdose.

In a study of over 35,000 patient visits for acute and chronic pain from 2001 to 2010, researchers found that the prescribing of benzodiazepines was three to four times more likely when opioids were prescribed.

Over a third of the patients prescribed opioids for chronic musculoskeletal pain were given a sedative. And patients with a history of psychiatric and substance abuse disorders were even more likely to be co-prescribed opioids and sedatives.

"Multidrug use is the trailing edge of the opioid epidemic," said Mark Sullivan, MD, a professor of psychiatry and behavioral sciences at the University of Washington School of Medicine. "We are making progress on decreasing opioid prescribing, but co-prescribing of opioids and sedatives has not decreased."

The study, published in the journal Pharmacoepidemiology and Drug Safety, estimates that opioid prescribing peaked in 2007. It’s the latest indication there has been a reversal in the growth of opioid prescribing – which has long been blamed for the so-called “epidemic” of prescription drug abuse.

In April, another study was released showing that the painkiller hydrocodone was no longer the most-widely prescribed drug in the U.S.

While opioid prescribing is in decline, researchers found no evidence that the co-prescribing of opioids and sedatives is also dropping. Opioids, benzodiazepines and muscle relaxants are all central nervous system depressants. Mixing the drugs is potentially dangerous because their interaction can slow breathing and raise the risk of an overdose death.

"Patients who are on long-term combined opioid and benzodiazepine therapy are often on a treadmill," said Sullivan. "They feel relief when they take their medications and withdrawal when they stop, so they continue this combined therapy, even though many function poorly and some will die as a result."

A study by the Centers for Disease Control and Prevention found that as much as 80 percent of unintentional overdose deaths associated with opioids may also involve benzodiazepines. Nearly 6,500 people died from overdoses involving benzodiazepines in 2010.

“We are seeing a disturbing increase in the use of benzodiazepines, mostly Xanax and Klonopin and Adderall. I call this the evil trifecta,” said Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis, Missouri area. “To make matters worse, the use of heroin continues to grow as Mexican farmers are switching to growing the opium poppy.”

While fewer opioids are being prescribed for pain, Menzies says there has been explosion in the use of buprenorphine – a weaker opioid – to treat addiction. For many years, buprenorphine was only available under the brand name Suboxone, but now there are several other buprenorphine brands competing in the lucrative addiction treatment market. 

“We have reduced the number of prescriptions for opioids but the use of opioids (primarily buprenorphine) are growing. Never in the history of drug treatment, has the sale of a medication exceeded $2 billion,” said Menzies in an email to Pain News Network.

Recent studies by the Substance Abuse and Mental Health Services Administration (SAMHSA)  found a ten-fold increase in the number of emergency room visits involving buprenorphine. Over half of the hospitalizations were for non-medical use of buprenorphine – meaning  many users took the drug to get high.

Over 50,000 visits to ER’s in 2011 involved a combination of benzodiazepines and opioids, according to SAMHSA.

Media Coverage of Pain Meds Often Unfair

By Emily Ullrich, Guest Columnist

As a chronic pain patient, I see a number of damaging political and social obstacles being added to the already desperate, often isolated and depressed lives of chronic pain patients.

Those of us who live with constant pain are too often disregarded by friends and family, who become frustrated that we haven’t gotten better, and/or begin to suspect that we are feigning or exaggerating our illness. In addition, doctors often label chronic pain patients as “drug seekers” and “malingerers.” Patients who need their help the most are often thrown by the wayside.

On top of these devastating blows, chronic pain patients face political, medical, social, and media scrutiny, and are often shamed out of seeking or pressing for the help they so desperately need. Some glaring mistakes are being reported in the media about drug use, overdose, and abuse. These mistakes are being repeated on a national level, and have created a culture of misinformation and stigma.

There is no doubt that addiction and overdose are serious issues which deserve our attention, but the media is manipulating the minds of consumers about the origin and nature of these issues, beginning with the subtle engineering and general processing of words. By that I mean the simple diction and placement of words used in articles regarding pain medication and illegal drugs.

For example, while an article discussing diabetes or blood pressure medication will refer to them as “medicine,” an article about pain medications will often refer to them as “drugs.” That places a negative connotation on the reader's perception of ALL pain medications as being categorically the same as street drugs.

I also read articles on a daily basis which pair pain medications and illegal drugs together in broad general statements, implying that the two are synonymous. In addition, the terms and implications about the use and abuse of pain medications are being used interchangeably; again reiterating in the minds of readers that if one takes pain medications, he or she is an addict, and that by simply taking pain medications he or she is abusing them.

These implications are untrue, unfair, and misrepresent chronic pain patients, misinform the public, and create unnecessary fear and sensationalism.

Like thousands of other chronically ill, legitimate pain patients in Kentucky and throughout the United States, I have been taking pain medication for many years. Without it, I cannot get out of bed and function. I have never once been "high" on them, and I've NEVER considered heroin use.

The real correlation between the two is that pain patients are being forced to fend for themselves and find relief on the streets with drugs like heroin. The government has scared doctors out of doing their jobs when it comes to addressing pain, and because of the media's continued manipulation and sensationalism in regard to pain medication, society now shames pain patients out of seeking medications they need.

There is an essential truth being conveniently omitted from most current articles regarding pain medication, street drugs and overdose, and that is that there is a direct correlation to the increase in heroin use and the implementation of growing numbers of laws that restrict prescription pain medications.

People are suffering, but instead of being treated with compassion, they are being treated like criminals and worthless members of society. Legitimate pain patients deserve access to the medications which allow them to operate, and doctors should not be afraid to help them. Patients should also not be made to feel they are illicit members of society for seeking a remedy to their medical conditions.

It is time that the media clearly differentiate between addicts who abuse pain medication and legitimate pain patients who use their medications as directed. Also, lines between pain medication use and the use of street drugs must be drawn.

Most importantly, politicians across the country must accept their role in the influx of heroin usage, and its direct correlation to the “War on Drugs.” Laws that limit the availability of pain medication are not based on truth (according to the U.S. National Library of Medicine, the real rate of addiction among chronic pain patients is a mere 3.27%), but are adjusted to fit the motives of politicians and scare the public.

Lastly, as chronic pain patients we must ensure that our voices are heard. We must educate and inform others and, most of all, demand our human right to adequate pain control.

Emily Ullrich suffers from CRPS/RSD, Sphincter of Oddi Dysfunction/Papillary stenosis, carpal tunnel syndrome, endometriosis, chronic gastritis, Interstitial Cystitis, uterine fibroid tumors, migraines, fibromyalgia, osteoarthritis, Periodic Limb Movement Disorder (PLMD), Restless Leg Syndrome (RLS), Myoclonic episodes, generalized anxiety disorder, insomnia, bursitis, depression, multiple chemical sensitivity, and IBS.

Emily is a writer, artist, filmmaker, activist, and has even been an occasional stand-up comedian. She now focuses mainly on pain patient advocacy as a delegate for Power of Pain Foundation, as she is able.

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.

A Pained Life: When There is No Cure

By Carol Levy, Columnist

There tends to be a misunderstanding in the minds of many, including doctors, that people who take opioids for their chronic pain believe it will “cure" their pain.

The idea behind a narcotic is the dulling of pain, or if you're lucky, stopping it in its tracks. It is not designed to “cure” anything.

Patients with kidney stones, as an example, are often given morphine, not because it will dissolve the stone, but because it will help reduce the pain.

When there is no cure, when the ultimate biological mechanism behind the pain is unknown, and when the patient is in pain, what is a doctor to do? What is a patient to do?

To me the answer is simple. They work together to find a drug(s) that will help relieve the pain. Often that means an opioid..

Trigeminal neuralgia (TN) is a good example.

Although theories abound as to the cause of TN, even the most long lived school of thought; that a blood vessel is pressing against the nerve, is not accepted by many in the neurosurgical community.

Some patients are helped by surgery, but a large portion do not and get little or no relief. In addition, many develop phantom pain -- called Anesthesia Dolorosa -- which is truly awful and life destroying in its own way. Does that mean a doctor should offer nothing to try and help? Or is this the time to offer an opioid?

Sometimes my Anesthesia Dolorosa pain is helped when I take my prescribed narcotic (codeine). On a really good day, which is very rare, it even helps my eye movement and usage pain.

Is it enough to make me "able"? No. The pain is still there.

Then how can I say it is helping?

It encases me in a layer of numbness, the pain somewhat outside of me.

Do I enjoy it? (A question asked by way too many) Absolutely not. The codeine swathes me in a net of sticky cotton, a sensation of suffocation and a loss of boundary. But the pain is farther away from me and I can breathe.

We have chronic pain. We know, for most of us, there is no cure.

But too many are trying to take away the one thing that helps some of us get freedom from the pain, even if only a fingertip full.

Please, those who say since there is no cure in a narcotic they should not be given; please, please understand. Even a soupcon of relief is acceptable when that is all there is.

And often, all there is is a narcotic.

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.

Fear of DEA Causing Drug Shortages

By Pat Anson, Editor

Millions of dollars in fines and thousands of investigations by the U.S. Drug Enforcement Agency have had a chilling effect on the nation’s drug supply chain, leading to quotas, shortages and legitimate prescriptions going unfilled, according to a new government report.

Pain patients have complained for years that it was becoming difficult to get opioid prescriptions filled, but the DEA called the evidence of that “anecdotal” and said it was not responsibility for any shortages.

In a survey of hundreds of pharmacies, drug wholesalers and physicians by the General Accounting Office (GAO), over half said DEA enforcement actions had limited their ability to supply drugs to patients. Many said they were fearful of being fined or having their licenses revoked by the DEA. Others blamed the agency for poor communication and unclear rules.

“In the absence of clear guidance from DEA some pharmacies may be inappropriately delaying or denying filling prescriptions for patients with legitimate medical needs,” the GAO report states.  

In recent years the DEA has fined distributors, pharmacies and practitioners over $94 million for violations of the Controlled Substances Act. Over 4,500 criminal investigations were also launched.

The crackdown helped lead to a reduction in prescription drug abuse and diversion, but it has also disrupted the drug supply chain. The GOA estimates that over half the distributors have placed a strict quota system on the amount of controlled substances that pharmacists and physicians can order.

“A distributor reported it refuses to distribute large volumes of controlled substances to prescribers or pharmacies that specialize in pain management, even if it has no evidence that the prescribers or pharmacies are engaged in diversion,” the GAO said.

One pharmacy chain told the GAO they were “afraid of being the target of DEA enforcement action even if they fill a prescription in good faith.”

Another small pharmacy chain said “we take things to the extreme to the point where we have received complaints from providers for turning away legitimate patients.”

“The DEA has NO communication out to pharmacies at all. The DEA is not preventative, it is all reactive,” one pharmacist complained. “The only experience we get with the DEA is hearing when they investigate and levy fines against a pharmacy for common pharmacy practices.”

The GAO recommended that the DEA improve its communication with distributors, pharmacists and practitioners so they would have a better understanding of what’s expected of them.

In response to the GAO report, a top DEA administrator wrote a letter stating there was only “anecdotal data that patient care is being compromised.”  

“The DEA would like to emphasize that it has no authority to control otherwise legitimate business decisions of registrants,” wrote Joseph Rannazzisi, deputy assistant administrator of the DEA’s Office of Diversion Control. “DEA and state partners have repeatedly and emphatically informed distributors that arbitrary thresholds are inappropriate, negatively impact legitimate patients, and are an inadequate substitute for fulfilling their obligations under the CSA (Controlled Substances ACT).”

The GAO report is the second this year to criticize the DEA for its management and policies. In March, we reported the GAO had faulted the DEA for "weak internal controls" and poor management of the system under which controlled substances are produced and distributed. The GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers.

The shortages have grown worse in recent years, according to many pain patients, who say controlled substances such as hydrocodone are increasingly difficult to obtain in some parts of the country.

Under federal rules, the manufacture and distribution of controlled substances is regulated by the DEA, while the Food and Drug Administration regulates what conditions the medications can be taken for. The two agencies are supposed to work together when shortages develop, but according to the GAO they do not have a “sufficiently collaborative relationship” and even “disagree about what constitutes a shortage.”

Major Study Underway for New Fibromyalgia Drug

By Pat Anson, Editor

Lyrica, Cymbalta, and Savella -- the only drugs approved by the U.S. Food and Drug Administration to treat fibromyalgia -- may be getting some competition.

A Japanese drug company, Daiichi Sankyo, is conducting clinical trials on mirogabalin, a new drug that could finally give fibromyalgia sufferers an alternative to the three approved medications -- which often don’t work or have too many side effects.

Daiichi Sankyo is currently enrolling patients in the “ALDAY” study, a large Phase III clinical trial evaluating the safety and efficacy of mirogabalin in treating pain from fibromyalgia. About 4,000 patients will be studied at 800 clinical centers in 40 different countries.

“We need men and women, 18 and older, who have been suffering from fibromyalgia pain for the last 3 months to participate in the ALDAY research study. If you qualify, you will be seen by a study doctor and receive all study-related medications at no cost. Compensation for study-related time and travel may also be available,” the company says on a website promoting the study.

A unique aspect of the ALDAY study is that it pits mirogabalin head to head against Lyrica (pregabalin), the top-selling fibromyalgia medication.  Both drugs bind to calcium channels that are believed to cause neuropathic pain. An earlier Phase II study suggested that mirogabalin may be 17 times more effective than Lyrica, although some critics questioned whether the design of the study was fair.

Advanced trials are also underway in Asia evaluating mirogabalin in the treatment of pain from diabetic peripheral neuralgia and postherpetic neuralgia (shingles).

“Pain associated with the neurologic conditions of diabetic peripheral neuropathic pain, postherpetic neuralgia and fibromyalgia can be debilitating,” said Lesley Arnold, MD, Professor of Psychiatry and Behavioral Neuroscience and Director of the Women’s Health Research Program, University of Cincinnati and lead investigator of the ALDAY program. “New treatment options are needed to help people living with these neurologic conditions relieve and manage their chronic pain and hopefully, improve their function and quality of life.”

The National Institutes of Health estimates that 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, depression, mood swings, and insomnia. There is no known cure and the disorder is difficult to treat.

Many fibromyalgia sufferers have complained that Lyrica, Cymbalta and Savella – which were originally developed to treat other disorders like epilepsy, anxiety, and depression – are ineffective for fibromyalgia.

“There are far too many off-label prescriptions written. These two classifications, anti-seizure and antidepressant, are frequently prescribed for pain on and off label. They come with far more side effects than opioids, but physicians feel, (and) are told, they are doing the right thing, when we are lacking statistics on after-market deaths associated with them,” said Celeste Cooper, a retired nurse, fibromyalgia sufferer and patient advocate.

“They completely reorder the brain and it is my opinion that these drugs should only be prescribed by physicians who specialize in brain chemistry (psychiatrist and neurologist) and know what interactions and side effects to alert patients, which is not being done currently.”

Dozens of patients wrote to Pain News Network with complaints of side effects from Lyrica and Cymbalta after a recent story about lawsuits involving the drugs.

“I took Cymbalta for a while. It didn't stop the pain of fibromyalgia, it just put 30 lbs. on me. I had my doctor wean me off. I got horrible Brain Zaps for a long time and felt terrible. Never take Cymbalta!” wrote Carol Fruzzetti.

“When I was on Lyrica I was literally walking into walls in my house or holding onto the wall for fear I was going to pass out I would get so dizzy. It made me feel like I was drunk all the time. I did not drive for fear I would kill myself or someone else. I will never take this drug again,” wrote Lana Straten.

Lyrica is one of Pfizer’s top selling drugs, generating $5.1 billion in revenue in 2014.  

Cymbalta generated annual sales of $5 billion for Eli Lilly until its patent expired in 2013 and cheaper generic versions of Doluxetine became available.

Savella generated sales of “only” $105 million for Forest Laboratories in 2013.

Pain Patients Should Come First

By Janice Reynolds, Guest Columnist

In the media, the persistent pain patient should always come first -- before the stories of addiction, overdoses and the inferences of poorly done studies linking the two with pain treatment. 

Most important is the professional relationship between provider and pain patient.  There needs to be therapeutic discussion between the two as to the nature of the pain, how it affects the person’s life, as well as what’s been tried and worked, and what has not worked. The goal should be a multimodal pain plan which works for the patient as well as being affordable.

The risk of addiction should be a concern, but not at the forefront.  Those seeing addiction as an “epidemic” linked with pain management have no valid research on which to base their concerns, only the media and addiction specialist hysteria. 

Unfortunately, many professionals as well as the general public are not only influenced by the media but learn from it as well. The yellow press of today is comprised of articles full of lies, half-truths, and prejudice.  This behavior is seen in professional articles as well.  Many times the basis for an article is some piece of research which is interpreted by the authors to conform to their point of view.

Not all research gives us proof or even a good indication of the truth.  Some studies are flawed and others are inherently bad.  An example of this is the CDC’s opioid overdose study, which is often cited to make the claim that over 16,000 American die every year from opioid overdoses. 

The CDC study is based on a review of death certificates and didn’t sort out legitimate opioid prescriptions, illegal use of opioids, suicide, deaths caused by alcohol or other medications, or even if the death was truly from opioids and not from some other disease process. Did the patient die from lung cancer or opioid toxicity?  Sometimes the latter is entered as the cause of death when it is not the case.  

Unfortunately this study is quoted by many.  If you say a tale often enough, it becomes a version of the truth.

Many times reporters get their information from questionable sources.  Their experts are frequently addiction doctors and occasionally others who are experts in their own minds.  Someone who is expert in pain management is seldom interviewed or quoted and when they are, their message is greatly outweighed by the others or taken out of context.  Selectively presenting “expert” testimony is at best a half truth. 

Reporters need to learn how to read and understand studies, especially if they are going to quote them. In order to know how valid a study is, the size, method, and strength of evidence all needs to be evaluated as well as any weaknesses.  Is this ever done by the media?

There are many fictions. Sometimes pharmaceutical companies are charged with trying to increase their sales by marketing pain medication.  One article said the Institute of Medicine’s report on chronic pain was influenced by the pharmaceutical companies. Another article claimed “our pain was greatly exaggerated” and severe pain really not that common. An article even stated hydromorphone was a long acting form of morphine, an outright untruth but never corrected. There are way too many fabrications to repeat.

One of the biggest challenges for people with persistent pain is the linking of addiction with treatment for pain. Not only the media does it, but even medical organizations geared towards pain such as PainWeek do it.  Yet a Cochrane Review on the available research shows only 4 to 5 percent of people taking opioids for pain become addicted, much less than the 17% in the general population who have addictive personalities. 

I realize there is an irrational fear of addiction (e.g. as a nurse, it was not unusual to have family members of a dying patient worried the patient would become addicted!), but the media should be educating more about pain, pain management, and the true reality of addiction rather than the dangers of addiction and the so-called “epidemic.”

In 1968 Margo McCaffery wrote, “Pain is what the person says it is, existing when he says it does.”  She was heavily ridiculed at the time.  Where Margo once said she would rather be fooled by ten people than let even one person suffer with pain, so many now would rather have 1,000 people suffer with pain than let one person fool them. 

In so many places now, the quality of pain care is measured by the number of prescriptions for opioids written (less is better). Compassion is a forgotten term. I heard a physician recently say only patients dying with cancer should be allowed opioids.

We need to see more accountability by providers and the media for understanding pain, learning about persistent pain syndromes, and about interventions both pharmaceutical and non-pharmaceutical.  There has to be education that not all interventions work the same for everyone; some work better, others may not work at all.

They need to learn if an intervention is affordable or doable. Some medications and many non-pharmacological interventions are not covered by insurance or covered minimally (6 physical therapy treatments a year won’t cut it), making effective therapies too expensive to pay out of pocket. 

Providers continue to get minimal education on persistent pain and treatment options in school.  But when it comes to continuing education they are required to get education on Risk Evaluation and Mitigation Strategies (REMS) for opioids, as well as identifying the addict, yet little about pain treatment.  This lack of edification hinders providers’ ability to care for patients and makes the provider more susceptible to the myths related to addiction.

Providers and the media need to realize the person with persistent pain “owns” their pain. They alone know what it is like, how severe it is, what it prevents them from doing, and most importantly, what works for them and what doesn’t. 

Ethics demand that persistent pain be treated. It is a human right.

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on different aspects of pain and pain management, and is co-author of several articles in peer reviewed journals. 

Janice has lived with persistent post craniotomy pain since 2009.  She is active with The Pain Community and writes several blogs for them, including a regular one on cooking with pain. 

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.

CDC Reports on Opioids Appear Biased

By Lynn Webster, MD, Guest Columnist

Like most people, I respect the opinion of the Centers for Disease Control and Prevention (CDC). It is our first and last line of defense against everything from chronic disease to full-fledged pandemics. That said, I am perplexed why the CDC would sound an alarm, while at the same time acknowledging that the fire doesn’t actually exist.

That’s more or less what the CDC did in a report finding that approximately a quarter of privately insured and a third of Medicaid-enrolled women of reproductive age (15-44 years) filled a prescription for an opioid each year from 2008 to 2012. The report went on to say that the trend of opioid prescriptions among childbearing women places unborn children at risk for birth defects. On this point, the report does not address how many of the women actually became pregnant and otherwise has a glaring absence of empirical data to support its claims.

If you are a clinician or scientist, the CDC report appears incomplete and biased against people in pain. If you are a patient or consumer of the news, the report is alarming. Neither of these outcomes advances medicine, nor do they help people who abuse prescription medication or those who experience chronic pain.

Without question, opioids must be replaced as a primary method of pain treatment in favor of safer and more effective therapies. It is clear that in many instances, the risks of opioid therapy far outweigh the benefits. However, many patients with pain have no other options, so until patients have access to effective alternatives, this type of reporting is counterproductive.

Because the report does not clarify the actual risks, nor compare them with the risks of continued pain in the absence of treatment, the CDC wades into dangerous territory of conjecture. Moreover, an overreliance on retrospective observational studies makes it difficult to evaluate the true impact of opioid use on the incidence of birth defects or whether other factors, such as the mother’s health status and co-occurring tobacco or alcohol use, were greater contributors. Although neonatal abstinence syndrome can definitely be traced to opioid use, the CDC investigators did not examine why the majority of infants born to opioid-consuming mothers do not develop it.

In addition to fuzzy reporting of the science, ethical issues are apparent in considering all women of childbearing age as fundamentally “prepregnant” when it comes to clinical decision making regarding opioid analgesia. These concerns were well delineated by Kristen Gwynne in an online article at RH Reality Check. Clinicians must always weigh potential benefits against potential harm before prescribing opioid therapy. But this has always been true of opioids and all medications, including nonsteroidal anti-inflammatory drugs, antidepressants and anticonvulsants.

The result of incomplete reporting could be the withholding of opioids from people based on gender and age, regardless of pregnancy status, even when strong pain-killing medications are indicated or when safer alternatives are not available. In fact, according to the American Congress of Obstetricians and Gynecologists, “Abrupt discontinuation of opioids in an opioid-dependent pregnant woman can result in preterm labor, fetal distress, or fetal demise.”

To be viable, alternatives to opioids must be effective and be covered by public and private insurance payers. Commentators who suggest opioids should not be prescribed often fail to present this important perspective and also imply that harm from opioids is inevitable, an error that contributes to the stigma and isolation felt by those whose lives would be crippled without their legally prescribed medications.

And yet, slanted reporting continues. In February, another CDC report appeared, endorsing scientifically vague opioid classifications of “stronger vs. weaker” than morphine. In analyzing the February report, June Dahl, PhD, properly pointed out the error in failing to consider the differing pharmacologic factors, mechanisms of action, formulations and the clinical relevance of relative effectiveness when comparing the medications.

Given the concerns with accuracy of scientific reporting, is it reasonable to increase federal funding to the CDC to battle prescription opioid abuse, as requested? Only with an understanding of the real reasons for the current opioid problem can we solve the problem. Perhaps more dollars should instead go to the National Institutes of Health, which is in desperate need of more funding for pain research and to develop safer alternatives to opioids.

Regardless, solutions cannot succeed in the absence of recognition that uncontrolled chronic pain is a major public health problem, worthy of focus similar to efforts to battle cancer, HIV/AIDS and other life-threatening diseases. Education of clinicians is good but cannot create treatment options or adequate insurance coverage where none exist. CDC officials and others must think about the problem differently and with less prejudice against people with chronic pain. Often the focus is on cutting supply alone; but in reality, this is difficult to accomplish without harming people with genuine pain when the payor system does not adequately cover evidence-based alternative therapies, including multidisciplinary integrative programs.

Instead payors, particularly government programs such as the Centers for Medicare & Medicaid Services and workers’ compensation, prefer the less costly opioid methadone, associated with more fatalities per prescription than any other.

Although a majority of opioid-prescribed patients do not abuse or become addicted, it is undoubtedly true that some people have contraindications for long-term prescribed opioids. These are potentially dangerous medications, which can be fatal. But effective solutions require a multifaceted approach and cannot ignore the needs of people in pain. Opioids formulated with abuse deterrents are needed as is greater funding and less stigmatization of people with the disease of addiction. Certainly, payors should cover safer and more effective therapies.

As I’ve said before, I hope opioids will one day not be needed, and commentaries like this one will be unnecessary. If the public health problem from opioids is too great, then it is the purview of the CDC to report on access to safer and more effective therapies in the interest of the other great public health problem: chronic pain. It is not an option to deny people in pain access to opioids if alternatives are nonexistent or unavailable.

Lynn Webster, MD, is Past President of the American Academy of Pain Medicine, and vice president of scientific affairs at PRA Health Sciences. He is a Pain Medicine News editorial board member and author of a forthcoming book, “The Painful Truth.”

This column is republished with permission from Pain Medicine News.

You can follow Dr. Webster on his blog, and on Twitter @LynnRWebsterMD, Facebook and LinkedIn.

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.

Study: Opioid Overdoses Occur Even at Low Doses

By Pat Anson, Editor

Overdoses from opioid painkillers occur frequently in people who are taking relatively small doses over a short period of time, according to a new study that has some experts calling for more restrictions on opioid prescribing.

Researchers at the University of Washington School of Public Health analyzed Medicaid data on over 2,200 opioid overdoses in Washington State between 2006 and 2010 – and found that many patients didn’t fit the usual profile of a long term opioid user taking high doses of pain medication.

The study, published in the journal Medical Care, found that less than half of the patients were “chronic users” who had been prescribed opioids for more than 90 days.

Only 17% percent of the overdoses involved patients taking a high morphine-equivalent dose of over 120 mg per day -- what is considered a "yellow flag" in Washington State for possible opioid abuse.

Surprisingly, nearly three out of ten (28%) patients who overdosed were taking a relatively low opioid dose of just 50 mg per day.

Sedatives were involved in nearly half of the overdoses and methadone in about a third of them.

In 2007, Washington State adopted some of the toughest regulations in the country on opioid prescribing -- guidelines that the researchers believe should be even more restrictive.

"It may be prudent to revise guidelines to also address opioid poisonings occurring at relatively low prescribed doses and with acute and intermittent opioid use, in addition to chronic, high-dose use," said lead author Deborah Fulton-Kehoe, PhD, a research scientist in the Department of Environmental and Occupational Health Sciences at the University of Washington School of Public Health in Seattle.

Based on the recommendations of this and other studies, Washington State’s Interagency Guideline on Prescribing Opioids for Pain was recently revised to caution doctors about prescribing opioids at any dose. The new guidelines extend to the treatment of acute pain, not just chronic pain. Physicians are also advised not to continue prescribing opioids to a patient if they don't show “clinically meaningful improvement” in physical function, in addition to pain relief.

While the overdose study focused on only one state, one expert says it has national and even global implications.

“The article notes that many overdoses occur when patients are prescribed medications at low doses. This has important implications for national policy and debate,” said  Dr. Jeroan Allison of University of Massachusetts Medical School, who is co-editor-in-chief of Medical Care. "The statistics are quite overwhelming and dramatic, and this problem affects every state in our nation."

According to the Centers for Disease Control, over 16,500 deaths in the U.S. were linked to opioid overdoses in 2010.

More recent data suggest that the “epidemic” of painkiller abuse is abating.

Hydrocodone prescriptions fell by 8% last year and it is no longer the most widely prescribed medication in the U.S.

A recent report by a large national health insurer found that total opioid dispensing declined by 19% from 2010 to 2012 and the overdose rate dropped by 20 percent.

According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

Power of Pain: Facing Insurance Challenges

By Barby Ingle, Columnist 

You may have heard about singer Avril Levine’s battle with Lyme disease, a tick-borne illness that left her bedridden for months with debilitating pain and fatigue.

It took a long time for Avril to be diagnosed correctly by doctors. She had to keep researching and advocating for herself before she was finally given proper treatment – a problem faced too often by people with chronic pain and illness.

Sometimes doctors cause these delays, but often insurance companies are responsible.

Americans receive their health care coverage from a variety of sources; through their employers, self-purchased policies, and public programs such as Medicare or the Affordable Care Act.

As the cost of healthcare rises, consumers have seen a significant hike in premiums and out-of-pocket expenses such as deductibles, copayments, and other cost sharing.

Insurance companies are also working to keep their costs down, through policies such as prior authorization, “step therapy” requirements, and specialty tier pricing on medications.

It can be a battle that is time consuming, frustrating, and depressing when an insurance company denies payments for a medication, procedure or medical device. Sometimes the issue is due to a provider entering the wrong code, but most often it is a cost savings issue. Insurance companies can make blanket denials and question whether a certain treatment is appropriate for you. 

What can be done to change this?

Step Therapy and Fail First

We need to abolish the unethical “Step Therapy” or “Fail First” practices by insurance companies – which require a patient to use a different (and usually cheaper) medication than the one prescribed by their physician.

There are patients from all over the United States reporting how they are being forced to switch from one drug to another. This has personally happened to me twice. Both times, I fought the ruling using my medical records and providers support, and the insurance company reversed the decision. However, others are not so lucky. In my case, I had already tried all of the medications that the insurance company was willing to pay for, and I had documented records stating my reaction to each of the medications.  

Usually, a patient can tell immediately whether a medication is working or not, and they should not be forced to stay on drugs that don’t relieve their symptoms. Applying step therapy protocols rigidly to a chronic care patient is not in their best interest and simply creates more challenges.

This practice is especially hard on pain patients who are women, minorities, and economically disadvantaged. Studies have shown these groups are most affected and are either disproportionately undertreated or untreated for pain. We must urge insurers to reduce health disparities in our communities.  

If you are faced with a step therapy situation, what can you do? I would suggest you appeal immediately. If you have already tried that medication, get copies of your providers’ records, and your journal entries, and submit them with your appeal.

You can use a journal to help the provider document how step therapy drugs fail to help or make things worse.  Note when complications and bad side effects occur, and report them to your doctor.

You should also have your provider fill out and submit a Medform 3500 to the Food and Drug Administration when you have a bad reaction to a medication or medical device. Send a copy to your insurance company. That documentation can increase the chances of a successful appeal  favorable to you.

Prior Authorization

There are many insurance plans that require prior authorization for expensive drugs or treatments and they may not provide coverage if you do not get prior approval. Once again, this tactic is used as a cost containment measure. Prior authorization covers the correctness, suitability, and coverage of a service or medication. 

The process differs with each plan, but is supposed to ensure that a patient will receive the appropriate level of care in the appropriate setting. This is actually a technique for minimizing costs, wherein benefits are only paid if the medical care has been pre-approved. It can delay care months to years, and can be life threatening and health deteriorating to the patient in many ways. 

Services that may require prior authorization include hospital admissions, back surgery, hysterectomies, maternity stays longer than 48 hours, observational stays, cosmetic procedures, experimental and investigational procedures, and some outpatient procedures.  

Specialty Tier

Insurance companies have divided medications and treatments into four main insurance tiers, based on type and price. The top and most expensive tier is known as the “specialty tier” or “tier 4 medications.”

Insurance companies classify the most innovative, expensive, and most essential to life medications as specialty tier.  These drugs can cost hundreds to thousands of dollars each month. Patients with chronic illnesses such as arthritis, Reflex Sympathetic Dystrophy, hemophilia, HIV/AIDS,  Crohn’s disease, Hepatitis C, multiple sclerosis, and many forms of cancer need these medications to help them function on a daily basis.  

According to the National Minority Quality Forum, 57 million Americans depend on specialty tier drugs that are often expensive and have no generic form yet available. 

With specialty tier pricing, a patient often pays a co-insurance instead of a co-pay, resulting in an out of pocket cost that can become astronomical. This often happens to patients who are  disabled, need catastrophic care, and have little or no income.

It is difficult to appeal specialty tier pricing decisions, as the medications are classified and a list is available to the insured at the time of coverage or when a medication is released to the market.

Many patients and providers give up when they get the first denial letter from an insurance company, but it’s important to keep fighting. An appeal can show a pattern that other patients with the same condition also need the same treatment. This can lead to an easier situation for other patients down the line, or if you need the procedure repeated.   

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the Power of Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

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

Study: Drug Abusers Responsible for Painkiller Misuse

By Pat Anson, Editor

A new analysis of a federal health survey has confirmed what many pain patients have been saying all along – that drug abusers, not patients, are largely responsible for the so-called epidemic of prescription painkiller abuse.

Researchers at the University of Georgia analyzed data from the 2011-2012 National Survey on Drug Use and Health. Over 13,000 Americans aged 12 and older were asked about their use of prescription drugs, illegal drugs, tobacco, and alcohol.

Less than 5% of those surveyed reported they had used a pain medication not prescribed for them or that they took it only for the "high" feeling it caused.

A further analysis of those abusers found that marijuana, cocaine or heroin use within the past year was the “only consistent predictor” of pain reliever misuse among all age groups.

"Male or female, black or white, rich or poor, the singular thing we found was that if they were an illicit drug user, they also had many, many times higher odds of misusing prescription pain relievers," said lead author Orion Mowbray, an assistant professor in the School of Social Work and the University of Georgia.

The findings are published in the journal Addictive Behaviors.

Asked where they obtained painkillers, the vast majority of the abusers said they did not get the drugs through a legitimate prescription, but had stolen them, acquired them from friends or relatives, bought them from a drug dealer, or used a fake prescription.

"If we know how people come to possess the pain relievers they misuse, we can design better ways to lower that likelihood," said Mowbray. "This study gives us the knowledge we need to substantially reduce the opportunities for misuse."

Adults aged 50 and older were more likely to acquire pain relievers through more than one doctor, although the rate of misuse in that age group was the lowest (1.7%).

People between the ages of 18 and 25 were most likely to misuse painkillers (10.2%) and more likely to get them from a friend, relative or drug dealer.

The study calls for greater coordination between medical care providers to reduce the possibility of over-prescription of painkillers, and for improving the communication between doctors, patients and the public.

"Doctors may conduct higher quality conversations with older patients about the consequences of drug use before they make any prescription decisions, while families and friends should know about the substantial health risks before they supply a young person with a prescription pain reliever," said Mowbray.

According to the Centers for Disease Control, over 16,500 deaths in the U.S. were linked to opioid overdoses in 2010.

More recent data suggest that the “epidemic” of painkiller abuse is abating.

Hydrocodone prescriptions fell by 8% last year and it is no longer the most widely prescribed medication in the U.S.

A recent report by a large national health insurer found that total opioid dispensing declined by 19% from 2010 to 2012 and the overdose rate dropped by 20 percent.

According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.

Is Cinnamon a Safer Pain Reliever?

By Pat Anson, Editor

A new warning from the U.S. Food and Drug Administration about the risk of serious side effects from non-steroidal anti-inflammatory drugs (NSAIDs) may have you thinking about finding safer, more natural pain relievers.

The idea isn’t new by any means – about 2,400 years ago the Greek physician Hippocrates was writing about the use of willow bark to ease aches and pains. Other natural remedies used for centuries to relieve pain and reduce inflammation include St. John’s Wort, ginger, ginseng, turmeric, and cinnamon.

Cinnamon, in fact, was recently found to be nearly as effective as the NSAID ibuprofen in relieving pain from menstrual cramps (dysmenorrhea).

The results of a small double-blind clinical trial, published in the Journal of Clinical and Diagnostic Research, evaluated the effects of cinnamon, ibuprofen and a placebo in 114 Iranian female college students. The women were broken up into groups of three; and given either 420 mg of Cinnamon Zeylanicum, 400 mg of ibuprofen or a starch placebo during the first 72 hours of their menstrual cycle.

Eight hours after treatment, researchers found that pain severity in the cinnamon group was significantly less than those who took a placebo, while pain severity in the ibuprofen group was less than those who took cinnamon.

Although ibuprofen was found to be the more effective pain reliever, the researchers believe cinnamon may be a better treatment for menstrual cramps because it doesn’t have the side effects of ibuprofen.

“The research results suggest that, Cinnamon as compared significantly reduces the severity and duration of pain during menstruation, but this effect is less compared to that of Ibuprofen. Due to the lack of adverse events in this study, Cinnamon can be used as a safe and non-pharmacological treatment for primary dysmenorrheal pain in young girls,” the researchers reported.

Iranian researchers have also found that thyme oil and lavender oil were effective in treating menstruation cramps, according to GreenMedInfo.

Last week, the FDA warned that "everyone may be at risk" from using NSAIDs – and ordered drug makers to strengthen warning labels about the risk of a fatal heart attack or stroke.

The warning applies to Advil, Tylenol, Motrin and other popular pain relievers sold over-the-counter, as well as all prescriptions drugs containing ibuprofen and acetaminophen. Many multi-symptom cold and flu products, such as NyQuil and DayQuil, also contain NSAIDs.

The agency said studies have shown the risk of serious side effects can occur in the first few weeks of using NSAIDs and could increase the longer people use the drugs. The revised warning does not apply to aspirin.

FDA: 'Everyone May Be at Risk' from NSAIDs

By Pat Anson, Editor

Warning that "everyone may be at risk," the U.S. Food and Drug Administration has ordered warning labels for non-steroidal anti-inflammatory drugs(NSAIDs) to be strengthened to indicate they increase the risk of a fatal heart attack or stroke.

The warning applies to ibuprofen, Advil, Motrin and other popular pain relievers sold over-the-counter, as well as prescriptions drugs containing NSAIDs. Many multi-symptom cold and flu products also contain NSAIDs.

The agency said studies have shown the risk of serious side effects can occur in the first few weeks of using NSAIDs and could increase the longer people use the drugs. The revised warning does not apply to aspirin.

“There is no period of use shown to be without risk,” says Judy Racoosin, MD, deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products.

The FDA said people who have a history of heart disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk for a serious cardiovascular event associated with NSAIDs. But the risk is also present for people who don't have heart problems.

“Everyone may be at risk – even people without an underlying risk for cardiovascular disease,” Racoosin said.

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are in so many different pain relieving products that health officials believe many consumers may not be aware how often they use NSAIDs. 

“Be careful not to take more than one product that contains an NSAID at a time,” said Karen Mahoney, MD, deputy director of FDA’s Division of Nonprescription Drug Products.

The labels for both prescription and over-the-counter NSAIDs already have information warning of heart attack and stroke risk. In the coming months, FDA will require drug manufacturers to update their labels with more specific information warning that the risk is heightened even in the first few weeks of use.

“Consumers must carefully read the Drug Facts label for all nonprescription drugs. Consumers should carefully consider whether the drug is right for them, and use the medicine only as directed. Take the lowest effective dose for the shortest amount of time possible," Mahoney said.

Several recent studies have found that NSAIDs increase the risk or heart attack and other health problems. The exact cause is unclear, but researchers believe NSAIDs may raise blood pressure and fluid retention, which can affect how the heart functions.  

A 2013 study published in The Lancet warned that high doses of NSAIDs may increase the risk of heart problems by about a third. In a review of over 600 clinical trials involving more than 353,000 patients, researchers found that NSAIDs doubled the risk for heart failure. People on high doses of the drugs also had up to four times greater risk for bleeding ulcers or gastrointestinal problems.

Another large study at the University of Florida in 2014 found that the over-the counter pain reliever naproxen raises the risk of a heart attack, stroke and death in postmenopausal women. Naproxen is a NSAID and the active ingredient in Aleve and other pain relievers commonly used to treat arthritis.

Studying data from over 160,000 postmenopausal women participating in a study funded by the National Institutes of Health, researchers estimated that using naproxen just twice a week raises the risk of cardiovascular problems by about 10 percent. The same study did not find a higher risk of a heart attack, stroke and death associated with ibuprofen, another type of NSAID.

Searching for Medical Marijuana’s ‘Therapeutic Window’

Dr. Mark Ware is one of the world’s leading experts on medical marijuana. Ware is an associate professor in Family Medicine and Anesthesia at McGill University in Montreal and director of clinical research at the Alan Edwards Pain Management Unit at McGill University Health Centre. He practices pain medicine at Montreal General Hospital.

Although medical marijuana is legal throughout Canada, and in 23 U.S. states and the District of Columbia, mainstream medicine still frowns upon its use. Research into the therapeutic benefits of cannabis -- particularly for pain management -- has also been limited.

Pain News Network editor Pat Anson recently spoke with Ware at the annual meeting of the American Pain Society. The interview has been edited for content and clarity.

DR. MARK WARE.

Anson: You’ve called medical marijuana an “incredible social experiment.” What do you mean by that? 

Ware: I think what we’re seeing is the lid coming off something that’s been going on for a long time. I think people have been self-experimenting with marijuana for years and years. People have been growing it in their basements and backyards. So there’s been a social experiment with cannabis since the 1960’s in the Western world.

I think the medical aspect of it has kind of followed through with that, because as you get thousands of people using cannabis, eventually somebody with an illness is going to stumble upon it. Lester Grinspoon (a marijuana researcher) reported on this in 1971. So that’s how long we’ve known or suspected the potential medical properties. The fact that the drug has been illegal has suppressed the possibility of there being much in the way of good quality research. So the experiment has been going on underground, out of sight and out of the public eye.

What we’re seeing now is that suddenly we’re able to talk about it. We’re able to look at this seriously. And we’re beginning to realize how much was already going on. So I think it’s an experiment that’s been going on for a long time and we’re beginning to put some parameters around it now, which allow us to track it more carefully. And hopefully it can yield some important results that can help inform the patient and the physician about what to do with this.

Anson: Some doctors have told me they don’t think marijuana will ever go mainstream until big companies like Pfizer and Purdue Pharma start backing marijuana research and doing clinical studies. Would you agree with that?

Ware: I don’t know if I would agree with that. That’s true for new pharmaceutical drugs. If you’re developing a molecule from the lab up, you need Big Pharma to come along and take that and move it to the point where they can do the big clinical trials.

With an herbal medicine, I think you almost don’t want to look at the pharmaceutical model for drug development. It’s more like how we regulate natural health products in Canada. We want good quality cultivation techniques, we want good quality processing, and we want to know what it is that we’re giving to patients.

I think fundamentally what we have to figure out is what we want to know about this drug. What is it that we need to know and how do we go about getting that information?

I think if we wait for Big Pharma to come along it’s going to be a long wait.  They would have been on this long ago if they thought this was important.

It’s a plant based medicine that’s already in our society at some level and we need to recognize the reality that mainstream doesn’t mean mainstream prescription availability. It’s going to mean mainstream figuring out how to put cannabis in a safe place in our society.

Anson: Medical marijuana is so widely available today, it’s like we’re already past the clinical trial phase.

Ware:  Exactly.  And to go back and do the Phase III study now, it’s expensive and would take hundreds of millions of dollars. And that requires knowing whether you’re going to get your money back. Companies invest that money when they know they’ve got a patent and they can make money back on the drug in the ten years after it’s launched. It’s much harder to see that happening with an herbal material like cannabis.

Why invest the money? It’s already available. You can already buy it at the dispensary. So now the question is how do we improve that process? How do we improve the quality of the product? How do we label them so people know what’s in them? How do we provide information to the patients that are buying them? What they should be looking for and what they should be careful about?

And how do we inform the physicians and health professionals who should be managing that whole process or at least informing it? What kinds of patients should be avoiding this? This isn’t for young kids. This isn’t for women who are pregnant. Some of this is obvious, but some of it needs to be specified and mandated.

I don’t think there’s strong enough evidence to start using cannabis in younger people. I think that the risks of cannabis on the developing brain in teenagers is significant enough that, unless there is a very real reason like a younger person with a severe intractable illness, this is a drug that should be held for the 25 and older crowd.

I would caution people who have unstable heart problems against using cannabis. It does increase your heart rate, can open up your blood vessels, and that could precipitate some heart problems.

Anson: What are the pain conditions that you think medical marijuana can be beneficial for?

Ware: I think for sure it’s more likely effective for chronic pain than acute pain. It’s never been reported for acute pain syndromes, but it has been reported for chronic pain.  There are clinical trials now that bear out that chronic neuropathic pain is one of the relieved conditions that it seems to respond to. We’ve seen reports for spinal cord injury, fibromyalgia, and PTSD (post-traumatic stress disorder). Cannabinoids appear to have some signals in some of these conditions.

And then you go beyond that to abdominal pain with Crohn’s disease, diabetic neuropathy, and so on. The list of conditions where it looks like it may work is as long as your arm.  There are individual case reports of cannabis being used on a huge range of conditions.

Anson: What is the most effective delivery system? Everyone thinks of smoking, but there are plenty of other ways to ingest marijuana.

Ware: There are. And I think the key thing is the difference between inhaling and taking it by mouth. The inhaled route is a very quick onset, has a very rapid effect on the patient, and then a fairly quick half-life; whereas the oral route takes much longer to absorb and takes a longer time for the patient to feel the effects. But then it lasts a lot longer. 

courtesy drug policy alliance

So it’s almost like a short acting versus a long acting medication. I don’t think there’s any way of saying one is more effective than the other. I think they’re effective in different ways.

If I was vomiting because of chemotherapy, I’d want something I could inhale to control the vomiting quickly. But if I’m not able to sleep because of my chronic pain, I want something that would be longer lasting so I could sleep through the night.  I don’t want to wake up three hours later and have to do it again. So I think we just have to figure out how to use the different administrative techniques for different clinical conditions.

Anson: Most of our readers are pain patients and when this subject comes up many of them say, “I’ve never tried marijuana. I’m curious about it and I’d like to try it, but I’m worried about getting high.” Can they get pain relief without getting high?

Ware: We’ve done studies where we kept the doses very, very small -- to the point where people have read the protocols and said you’re not giving these patients enough to feel the effect. And in fact, what happens is patients are still able to find analgesic benefit and avoid that euphoric or psychoactive effect.

That’s important for most patients. They want to be able to use a drug or any kind or a therapy that doesn’t impair them from doing the things that they need to do. They need to drive. They need to work. They need to hang out with their families. They need to do their sports and their activities. And this is part of pain management generally. We want people to be living as full and as active a life as possible. We don’t want them collapsing on the couch all day long.

So can we find that window, what we call that therapeutic window, that dose where you get the benefit but you don’t get the sedative or psychoactive effect? And I think we can. I think for patients who are considering this approach, they really have to learn to be very patient and use very, very small doses. Try very small amounts first and allow your body to feel what the drug is doing to you. And if nothing happens, that’s okay. You’ve started with a low enough dose that you felt nothing. You gradually work your way up.

The interesting thing about cannabis is that there are two ways of thinking about dose. One is the amount of the drug itself, the number of grams, joints or pipes, if you will. The other is the THC level of the cannabis itself.

courtesy drug policy alliance

If patients have access to material where the THC level has been standardized or has been measured, they should be trying to use THC cannabis that is as low as possible, because the likelihood of having a psychoactive reaction to a high THC cannabis is much higher.

If it’s high in THC, it doesn’t take much to get that effect, where if they use very low THC levels, less than 10 percent THC, and they use a small quantity of the material, then potentially they can find that therapeutic window that can be effective.

Anson: What about taking marijuana with opioids? Can you do that?

Ware: You can. There’s no medical reason why you shouldn’t. I think the key thing for patients who are doing that, and again I emphasize with the knowledge and support of their physician, is that they can reduce the doses of other medications which may not be helping as much.

Cannabis use can be seen in terms of improving patients in two ways. One is in reducing the medications that they’re already taking, which may have side effects. And the other is in improving their functioning state so that they’re doing more. This is where I think the responsibility lies with the patient to prove to the doctor that this drug is helping. And you do that by reducing your other medications with the doctor’s support, by increasing your functioning and by showing that you’re doing things that you weren’t doing before. That is what doctors want to see.

There appears to be evidence, at least in animal studies, that opioids and cannabinoid drugs work synergistically. So if you take the two separately and you take the two combined, you get a greater effect with the combination than if you took either of the others by themselves.

This synergism, we’ve seen it in patients who started using cannabis successfully and they were able to reduce their other medications. In some cases they find that the dose of opioids they were taking, they can lower it and get a similar effect with much lower doses. With others, they don’t need the opioids any longer and they can taper off it and stop completely. 

Anson: One fear of using medical marijuana is that it could make you more prone to abusing other substances.

Ware: I think patient selection is very important when you’re considering as a physician whether to authorize or prescribe cannabis, because cannabis is a drug with a known risk of abuse and dependence by itself. There are people who struggle with their marijuana use and withdrawal when they try to get off it. Physicians need to be sure they’re not making things worse for a patient that has a dependency disorder by authorizing cannabis.

Screening for dependence means looking for abuse of other substances, such as alcohol. If you’ve done that carefully, prescribing cannabis to a patient who doesn’t have that addiction risk appears to be fairly safe.

Medical cannabis should be used as an option only when all the conventional therapies have failed; when all of the other approaches to pain management, and I’m not just talking about pharmacology, but when all of the non-pharmacological approaches have all been considered and tried. Cannabis is not at the point where it can be thrown in as a first line agent for a patient struggling with pain management.

Anson: Thank you, Dr. Ware.