Opioids, Off-Label Prescribing and the Road Not Taken

By Lynn Kivell Ashcraft, Guest Columnist

So much of the conversation about the use of opioids and other medications to treat various conditions has made it sound like doctors are doing something wrong when they utilize a treatment in an off-label fashion. 

Off-label prescribing is not a crime. The federal Agency for Healthcare Research and Quality (AHRQ) estimates that 1 in 5, or 20 percent, of all prescriptions are written for off-label use.

In fact, off-label use of a drug often represents the standard of care. The Food and Drug Administration never intended for its drug approval and labeling process to be the sole determining factor in how a drug is to be used in a clinical setting. 

It is left to physicians themselves to determine the ultimate clinical utility of pharmaceuticals, biologicals and medical devices in treating their patients.

Epidural Steroid Injections Are Off-Label

Some off-label use, however, is controversial. Many accepted protocols for treating back and neck pain include the use of epidural steroid injections (ESIs), despite a lack of rigorous supporting clinical evidence. As many as 9 million ESIs are performed in the U.S annually, yet few patients are told the injections are an off-label use of both the medication (corticosteroids) and the route of administration (an injection into the epidural space of the spine).

In 2014, after hearing about serious neurological problems in patients who received ESIs, the FDA required a label warning that injections of corticosteroids into the epidural space may result in rare but serious neurological events, including "loss of vision, stroke, paralysis, and death."  

Anxious not to lose a treatment that they believed in, professional societies of anesthesiologists, pain medicine physicians, rehabilitation specialists, neurosurgeons, surgeons, radiologists and interventional pain specialists wrote guidelines to prevent complications from ESIs that were published in the journal Anesthesiology in 2015. 

A coalition of doctors also formed the Multisociety Pain Workgroup (MPW) to defend the use of ESI’s. The MPW called an AHRQ study “flawed” and “absurd” because its questioned the effectiveness of ESI’s for treating low back pain. It also lobbied unsuccessfully to have the FDA tone down its warning.

Since 2017, according to OpenSecrets.org, the American Society of Interventional Pain Physicians has spent nearly $1.5 million on campaign donations and lobbying — much of defending the use if ESIs.

Where was the same type of outcry from the medical profession defending the use of opioid medication when the 2016 CDC guideline was released? Why have so many doctors stood by silently while insurers, states and the DEA began implementing the guideline as policy?

Lynn Kivell Ashcraft is an analytic software consultant and writer who lives in Arizona. Lynn has lived with chronic intractable pain for almost 30 years and works with Dr. Forest Tennant as part of the Arachnoiditis Research and Education Project. 

How to Recover From a Painful Breakup Caused by Chronic Illness

By Ann Marie Gaudon, PNN Columnist

What no one talks about. Getting “dumped” because you have chronic pain or illness. Let’s talk.

There’s no denying the unbearable emotional pain if someone you love decides they’ve had enough. The reality is that people can be cruel, including people that you never thought had it in them. Here’s a few zingers I’ve been made aware of:

“You’re always in pain and I’m sick of it!”

“I never signed up for this sh*t!”

 “I’m so done looking after you!”

Sound harsh? It is, and it happens. While the breakup might be blindsiding, the reality is that the partner has likely been emotionally disengaged for some time. By the time they say those words, they are essentially over the relationship. However, for the person hearing them, they are likely in the initial stages of grief.

If you’ve seen messy breakups in the movies, you might think the answer is fuzzy pajamas and a litre of chocolate chunk ice cream. This will take more than a visit with Bridget Jones.

MRI brain scans have shown that the withdrawal of romantic love activates the same brain mechanisms that get activated when someone suffering from substance abuse goes through withdrawal. That is powerful pain. This would explain why we can obsess over ex-partners and crave them as if they were a drug we've been deprived of.

How to help yourself? Ensure the thoughts you have about your ex are realistic and balanced. If your memory consistently goes to that “best night of your life,” remember all the other nights that were upsetting to you. If you are consistently longing for their loving embrace, remember the nights that your advances were rejected.

What Went Wrong?

If you’re really struggling to get a grip on the reality of the relationship, write a list of all the reasons that it went south. You will see that it wasn’t 100% due to your pained body.

The point is to take a wider look and get a better perspective on the entire relationship. While you are emotionally depleted, your focus will tend to be narrow and unrealistic.

Accept explanations that fit the facts -- such as they were unwilling to make a commitment or they were not the person you thought they were. Avoid creating a harsh inner critic about why the breakup happened and see the relationship for what it was. Make a list of compromises that you made in this relationship that you would rather not make next time. What did you learn about yourself? Can you grow from this?

Do not check on your ex through social media. This will make it harder for you to stop fantasizing about your relationship and spending your time marinating in self-pity while imagining your ex out there living their best life sans you. Remove reminders of your ex such as photos, emails, or messages which will only add to your distress.   

Take control of your behaviour. Do things that used to bring you joy, even if they don’t at the moment. Continuing to engage is a very important way to tell yourself that life does go on. 

Reach out to friends, family or other loved ones to gather all the support you need. We all know what breakups are like and we all have our own words of wisdom to offer.

If your grief is not lessening with time, reach out to a therapist. A trusted therapeutic relationship can help you find your voice to express your grief in a healthy, healing way. A skilled therapist can also help you to develop new social relationships and a sense of self-worth to help decrease isolation and pain-related depression.

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.

Poppy Seed Tea: Deadly Potion or Potent Pain Reliever?

By Pat Anson, PNN Editor

You can find poppy seeds in cakes, cookies, muffins and salad dressings. The tiny versatile seed is even used in cosmetic products as a skin moisturizer and exfoliant.

What you may not know is that poppy seeds can also be used to make tea. The bitter homemade brew doesn’t taste good, but some chronic pain sufferers have discovered poppy seed tea is a potent pain reliever.

“This fall I will be growing opium poppies and extracting my own medicine. I did grow a few plants last year and the tea I had made from those poppy pods was extremely helpful,” said Ed, a pain patient in Texas who was taken off opioid medication by his doctor.

“I do know the dangers and illegality of doing this, but a man has to do what a man has to do for relief. I have exhausted every legal option I can think of. There is absolutely no help from the medical community around here.”

Ed is not alone. He and other patients who have lost access to opioid painkillers have learned that unwashed poppy seeds contain opium alkaloids that, when soaked in water, can be converted into morphine and codeine.

It takes hundreds of poppy seeds to brew a single cup, but the seeds can be purchased cheaply in bulk for about $10 a pound from online retailers like Amazon and eBay.

“This means for under $15/week I can be back to being a partially functional human being. I am doing way better than I was on the measly 20mgs of Oxy I had been struggling and stressing to get from the doctors,” said another pain sufferer, who claimed she used poppy seed tea to wean herself off oxycodone.

“Safe if used carefully. Easy to make and drink. You can add things like lemonade to make it taste better.”

DEA Warns About Unwashed Seeds

Poppy seeds make up only a tiny part of the worldwide trade in opium products, most of which comes from Afghanistan. According to The Washington Post, four times as much Afghan land is being used in poppy production today than in 2002, shortly after the U.S. invasion. Afghanistan now produces 82% of the world’s supply of heroin, far more than it did under Taliban rule.

With poppy seeds readily available online, the Drug Enforcement Administration recently closed a loophole that allowed unwashed seeds to be sold legally in the U.S. While the poppy plant has long been classified as an illegal controlled substance, the seeds were exempt because they don’t normally contain opium alkaloids. Whether by accident or design, many seeds become contaminated during harvesting.

“Harvesters, who wish to increase opium alkaloids contents on the poppy seed coats, make cuts in the opium pods before they ripen which allows the latex to seep onto the seed coats. Individuals wishing to extract the opium alkaloid content from unwashed poppy seeds, use the seeds to create a tea, which contains sufficient amounts of alkaloids to produce psychoactive effects,” the DEA said in a little publicized announcement that it was classifying unwashed poppy seeds as a Schedule II controlled substance.

“Unwashed poppy seeds are a danger to the user and their abuse may result in unpredictable outcomes including death when used alone or in combination with other drugs as reported in the scientific literature.”

The scientific literature on poppy seed tea is actually very limited. But one recent study urged policymakers to fix the “murky legal status” of poppy seeds and warn patients about the potential dangers.

“With no legal restrictions and apparent endorsement from reliable brands and trusted websites, patients may have little reason to think this tea is actually a version of morphine,” said lead author Jo Ann LeQuang, Director of Editorial Services for NEMA Research.

“I am happy to see the DEA finally take a stance,” says Madeleine Gates, PhD, an Assistant Professor of Forensic Science in the College of Criminal Justice at Sam Houston State University. “I think the poppy tea problem is just another devastating aspect of the opioid epidemic.”

In a 2017 study, Gates used four brewing methods to test 22 samples of bulk poppy seeds purchased legally on the internet. Her research, published in The Journal of Forensic Science, found that a potentially lethal dose of morphine can be brewed in a moderate amount of tea.

“When I was originally contacted to work on poppy tea, I had honestly never heard of it! Now it’s been so eye opening about the drug use that had flown under the radar for too long,” she said in an email to PNN.

Gates began investigating poppy seed tea after being contacted by the father of a 21-year-old man who died after ingesting home-brewed tea. A dozen similar deaths were cited by the DEA in its warning, but Gates believes there could be many more cases.

“I’ve spoken with physicians who are treating poppy tea addicts. I’ve also been involved in a case of a pregnant woman who naively used poppy tea during pregnancy and upon delivery her infant went into withdrawal,” she said.

“I’m sure there have been other cases that are yet to be reported or that may be overlooked. For those who may be known opioid addicts that would have morphine in their system for a hospital or autopsy toxicology test, the first thought is not to think of poppy tea. For that reason, those intoxications or fatalities wouldn’t necessarily be tied to poppy tea unless there was investigative information to link to the case.”

Poppy Tea Addiction

The Internet is filled with stories about illicit drug users experimenting with poppy seed tea. Some became addicted to the tea and went into withdrawal when they ran out of poppy seeds.

“I never got my seeds in time so the awful opiate withdrawals started. I made it two days until I had to go to hospital for withdrawals. I wanted to die!! It’s soooooo horrible. Never felt this way before,” one user posted on Reddit. “I wish I looked into this god damn tea before I started. Didn’t know the withdrawals were going to make me wanna kill myself. Please don’t get addicted to poppy seed tea. It’s awful addiction hard to stop ruins your life.”

Despite the DEA warning, unwashed poppy seeds are still being sold online. A controversial alternative health website even had a recipe for making poppy tea – since taken down — that came with a stark warning.

“Unfortunately, the abuse of or having insufficient knowledge about this tea has led to a few fatal incidences,” the recipe warns. “If you're planning on trying this tea, it's important that you're aware of your own threshold and sensitivities. It's also imperative that you test each batch of poppy seed tea to make sure that you're not unknowingly ingesting high amounts of the opiate alkaloids.”

Another drawback is that even a small amount of poppy seeds in a muffin or cookie can produce a positive reading for morphine in a drug test. That could result in a patient being dropped by their doctor or a referral to addiction treatment

But for some chronic pain patients, the urge to self-medicate is strong and worth the risk. Many, like Ed in Texas, feel abandoned by a healthcare system that has become paranoid about opioid medication. If doctors won’t treat his pain with a legal drug, then Ed believes he has a right to try whatever substance he wants.

“It is my personal observation that the so called medical ‘profession’ around here is lacking professionalism and is poor at best. At times I feel like a drowning man sinking into a deep pool of despair,” Ed wrote in an email. “It is my opinion that people with chronic pain issues should have the ability to break the cycle of the pain that plagues them. I understand the addictive nature of opiates and I feel that I am a responsible adult.”

Landline More Important Than Cell Phone for Chronically Ill Patients

By Barby Ingle, PNN Columnist

I cannot stress enough the importance of having a traditional landline when people are turning to cell phones or internet-based phone systems (VOIP). In 2018, over half of American households were "wireless only homes."

People are switching for cost and convenience, but many are unaware of what they’re losing when they drop their landline. This is a topic close to my heart, because my own father would still be here with us if he had a working landline the night he passed away.

We see television shows where people use their cell phones to call 911 to report a fire or emergency. The fact is it doesn’t work that simply.

Major limitations are introduced when you call for help from a cell phone or VIOP system, which can leave a chronically ill person or someone in an emergency situation unable to receive help immediately.

As a pain patient whose husband worked outside of our home for years, this is something to know and take steps to remedy before something happens to you.

There are a variety of reasons to keep your landline. One would be quality. A landline gets a clear, reliable connection with virtually no delays or lag times. When I do a radio or podcast interview, they usually ask that I call on a landline. Audio issues on a radio show typically occur when a guest is calling from a cell phone or computer.

Calling 911 for help from an area with a weak wifi or internet signal can cause problems. If they can’t hear you clearly, that can delay getting help to you.  A landline almost always provides clear coverage because of the telephone network infrastructure in place across the USA. You don’t have to rely on spotty tower connections or a slow internet.

Many home alarm systems also use landlines, because even when the electricity goes out, the phone line won't. If the alarm system is hooked up through VOIP or a cell phone, there is no guarantee that the call will go through or the person will understand you.

During last year’s disastrous wildfire in Paradise, California, many cell phones were useless because phone towers were damaged or lost electricity. Residents without landlines couldn’t be warned about the approaching fire and over half of the cell phone calls to 911 failed.

Home Alone? Then Keep Your Landline

Having a landline to call in emergency situations is worth the expense. At an additional cost of about $10-20 a month you can have a basic landline active in your home so that you can call local numbers and emergency numbers such as 911 or 0.  

As a chronically ill person myself, I am home a lot. My cell phone service is not great at our house due to the rural area we live in. We use the traditional landline even for regular calls with our family, friends and of course in emergency situations.  

The biggest reason to have a traditional landline is safety. With a landline, you don’t even need to speak.

As long as you can get the phone off the hook and dial “O” for an operator or 911 for emergency services, they can listen in -- in case you are being robbed and need to be quiet or unable to speak for any reason.  

Another advantage of a landline is that your street address comes up automatically on a 911 operator’s computer screen. They know precisely where you are calling from.

That is not always possible with a cell phone. They may be able to determine what cell phone tower your call is being routed through, but they won’t know your exact location.

Imagine your child trying to call 911 because you are having a seizure or unconscious. If the child is too young to speak or remember your address in an emergency situation, a cell phone might as well be a toy.  

If you can only afford one phone line, make it a traditional landline if you spend most of your time at home due to chronic illness. Chances are when you’re out and about, others will have a cell phone and be able to call emergency services for you.  But when you are home alone, trust me, having a landline can save you time, money and perhaps even a life. This is a fact that my family found out firsthand with the death of our father.  

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International 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.  

Living with Chronic Pain During the Holiday Season

By Dr. Lynn Webster, PNN Columnist

The holiday season is underway, but that doesn't mean everyone is healthy enough to celebrate. Chronic pain does not take a vacation or even ease up in honor of Christmas, Chanukah, Kwanza or any other holiday.

People who are in unremitting pain will suffer, while others throw themselves into endless rounds of joyous holiday-related activities.

For those in pain, and their caregivers, it may not be possible to participate in shopping, decorating or partying. They may feel disenfranchised, abandoned and hopeless. I have received hundreds of emails from people in pain who feel alone. Their doctors may have abandoned them or been unable to provide medication that can help manage their pain.

Holiday-themed social media posts, movies and television shows make it appear as if everyone is, or should be, happy and productive during the final weeks of the year.

However, the truth is that the holiday season can be stressful for many people, regardless of their health. Financial burdens, overindulging in food and alcohol, and getting too little sleep can take their toll.

Family members and friends may fail to empathize, even when they have fewer distractions and social obligations. During the weeks leading up to the New Year, people in pain may feel even more isolated than usual.

Universal holiday bliss is an illusion for many. Other people may long for the commotion of the season to end, too, so calm and normality can return. If you're finding the season to be something other than a never-ending winter wonderland, you have plenty of company in feeling that it is not.

Ask for What You Need

The holiday season does not require you to pretend that you are not in pain. You do not have to wear a mask of well-being in order to ease the burden of others. It is not your job to fake a positive attitude that you do not feel. Your responsibility is to take care of yourself.

You are not obligated to accept invitations for get-togethers, shop for gifts, or decorate when you are experiencing pain.

While other people may hope that you will put on a brave face, you are not required to fake anything you do not feel. On the contrary, you should be honest about your needs and give others a chance to share part of the holiday season with you.

Do let your loved ones know that you are there, and that you are thinking of them. If mobility is an issue for you, consider inviting a relative or friend to visit you. Be up front about the fact that you could use help with meal preparation and cleanup, sending cards, and the like.  

If there is no opportunity to get together with people you care about, perhaps you can arrange an online chat using Skype or a similar service. Ask the children in your life to participate, too. Even active teenagers and sleepy toddlers may be able to find a few minutes to share quality time with you. 

While you may not be able to participate in all of the holiday season activities, you can experience some of the love and joy you deserve if you prompt others to help. 

Seek Support 

Feeling isolated may be one of the most difficult aspects of living with pain during the holiday season. Consider joining a support group so that you can share your burden with people who understand what you are going through. The U.S. Pain Foundation and the American Chronic Pain Association list support groups online that you might benefit from joining.  

Caregivers fill a role that I have described as everyday saints and unsung heroes. However, even saints and heroes can experience burnout around the holiday season.  

It's especially important at this time of year for caregivers to practice self-care. This may include tapping into a caregiver support group and asking family members and friends to provide a short-term reprieve.  

Empower Yourself 

While you may not be able to invest yourself fully in the holiday season festivities, you still have power to take positive action. Reach out to lawmakers, and ask them to support more humane opioid prescribing policies. Contact your local members of the House of Representatives and Senate. Also, send a letter to the editor of your local newspaper and contact the news departments of your local television and radio stations.  

For many Americans, the holiday season is associated with faith. This is a good opportunity to remember that scientists are working on finding better and safer ways to manage pain. Policymakers are beginning to admit that tapering unwilling patients can cause harm.

There is hope that the New Year will bring us closer to solutions for people with pain. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is the author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find Lynn on Twitter: @LynnRWebsterMD.

Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. 

Drug Legalization Needs to Consider Drugs That Haven’t Been Invented Yet

By Roger Chriss, PNN Columnist

Drug decriminalization and legalization have become hot topics in the U.S. and around the world. Some states have legalized recreational cannabis and a handful of cities have decriminalized psilocybin, a hallucinogen found in some mushrooms. Countries like Portugal have decriminalized all drugs.

The arguments in favor of legalization seem reasonable, from harm reduction and de-stigmatization to access to a well-regulated supply of substances that people are going to use regardless of whether they are legal or not.

But rarely are questions asked about the drugs that haven’t been invented yet. Debate about legalization usually centers on popular but controversial substances like cannabis, with no mention of novel fentanyl analogs or other new psychoactive substances.

Novel opioids appear on the dark web regularly. For instance, the potent synthetic opiod isotonitazene is now being sold online, even though a team of international researchers said it “represents an imminent danger.”

Public health officials in the U.S. also recently warned about isotonitazene in the journal NPS Discovery, after the drug was identified in blood samples from eight overdoses deaths in Illinois and Indiana.

“Pharmacological data suggest that this group of synthetic opioids have potency similar to or greater than fentanyl based on their structural modifications,” they warned. “The toxicity of isotonitazene has not been extensively studied but recent association with drug user death leads professionals to believe this new synthetic opioid retains the potential to cause widespread harm and is of public health concern.”

Similarly, there are reports on overdoses with cyclopropylfentanyl, a chemical cousin of fentanyl that first appeared in Europe in 2017.

“The constantly growing diversity of NSO (new synthetic opioids) still poses a high risk for drug users and can be a challenging task for clinicians and forensic toxicologists. Clinicians treating opioid overdoses should be aware of the potentially long lasting respiratory depression induced by fentanyl analogs,” German researchers said.

Novel Substances

This problem is not limited to illicitly manufactured fentanyls and other opioids. Novel synthetic cannabinoids also pose risks. Such compounds include JWH-018 and AKB48, both known to be dangerous.

And the world of hallucinogens, amphetamines and other psychoactive substances is evolving, too. Psilocybin can now be harvested from bacteria and over 150 synthetic cathiones-- amphetamine-like psychostimulants -- have been identified in clandestine drug markets.

“Over the past hundred years or so, humankind has learned to synthesize the active chemicals in laboratories and to manipulate chemical structures to invent new drugs—the numbers of which began growing exponentially in the 2010s,” Ben Westoff notes in Fentanyl, Inc.

Further, drug consumption technology is changing rapidly. Just as the hypodermic syringe forever changed the risks of heroin, vaping devices are having similar effects. They allow for high-intensity consumption of nicotine, THC, and other drugs that contain unknown contaminants, as seems to have happened with vitamin E acetate in the recent outbreak of lung illnesses associated with vaping.

Lastly, there are risky interactions that can occur with the use of novel substances. The American Council of Science and Health points to the particularly important issue of drug-drug interactions. The world of street drugs now involves so many adulterants and contaminants that, when combined with novel substances, drug-drug interactions are potentially more dangerous than ever.

Historically, legalization of drugs has not led to a net public health benefit. And that was when “drugs” consisted of plant matter or distilled liquids. Modern technology means we can do much better, which in turn means we may be facing far worse.

The greatest risks arguably come from the drugs that have yet to be invented and the interactions that have not been discovered. Any discussion of full drug legalization needs to consider such possibilities.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

Health Risks of NSAIDs Led to ‘Significant Under-Treatment of Pain’

By Pat Anson, PNN Editor

The opioid crisis has been blamed on a lot of things, everything from pharmaceutical marketing to poor medical education to an epidemic of despair.

Now we can also blame NSAIDs.

A new study by researchers at Boston University School of Public Health (BUSPH) found that a decline in prescriptions for non-opioid analgesics — mostly non-steroidal anti-inflammatory drugs and COX-2 inhibitors -- coincided with a marked increase in opioid prescribing for people with chronic musculoskeletal pain.

Concerns about the cardiovascular side effects of Vioxx and other COX-2 inhibitors first came to light in the early 2000s. More was also being learned about heart disease, strokes and gastrointestinal problems associated with NSAIDs.

"While the opioid epidemic is complex and has many possible causes, our findings suggest that health risks associated with NSAIDs were one factor that led to increased prescribing of opioids," says lead author Dr. Andrew Stokes, assistant professor of global health at BUSPH.

Stokes and his colleagues looked at 1999-2016 prescription data for over 7,200 U.S. adults with back pain, neck pain or arthritis. Increases in opioid prescriptions matched the decrease in prescribing for non-opioid analgesics (predominantly NSAIDs and COX-2 inhibitors) between 2003 and 2006.

"We realized that the point at which increasing opioid prescriptions crossed over with the decrease in non-opioid prescriptions occurred when the cardiovascular risks of COX-2 inhibitors led to rofecoxib (Vioxx) coming off the market. The gastrointestinal risks of NSAIDs were also well-recognized by then,” says senior author Dr. Tuhina Neogi, a professor of epidemiology at BUSPH and Chief of Rheumatology at Boston Medical Center.

“Thus it appeared to us that an increase in opioid prescribing during that time was, at least in part, an unintended consequence of COX-2 inhibitors coming off the market and concerns about NSAID risk.”

‘Unmet Need for Pain Management’

The study, published in JAMA Network Open, also found that growing recognition of the opioid crisis after 2013 led to decreases in opioid and non-opioid analgesic prescriptions for people with chronic musculoskeletal pain, particularly among those with less education and lower socioeconomic status.

"Care is needed to ensure that our response to the opioid crisis does not leave people living with chronic pain behind. The abrupt decline in prescribing to those of low socioeconomic status is concerning given that these same individuals also face the greatest barriers to accessing alternative pain treatments, such as physical therapy," Stokes says.

"There's so much talk now about transitioning people away from opioids. But if that's happening without considering the barriers to non-pharmacologic treatments, there may be a significant problem of under-treatment of pain," adds study co-author Dielle Lundberg, a research fellow at BUSPH.

Between 2013 and 2106, researchers found an 11% decrease in prescriptions for both opioid and non-opioid pain relievers, suggesting a significant amount of pain was going untreated.

“Care is needed to ensure that our response to the opioid crisis does not leave people living with chronic pain behind.”

— Dr. Andrew Stokes

“The fact that the present study was restricted to patients with potential needs for pain management also raises the concerning possibility that an unmet need for pain management has increased over this period. Such a trend would be alarming given evidence that untreated chronic pain may prompt patients with chronic pain to seek out illicit heroin or fentanyl,” researchers concluded.

“In addition, several recent studies based on data from the National Violent Death Reporting System have found a high rate of chronic pain among suicide decedents, and recent research and commentary on opioid discontinuation have suggested that recent increases in the suicide death rate may be linked to changes in pain treatment.”

Backlash Against Nurse Who Mocks Patients for Faking Illness

By Crystal Lindell, PNN Columnist

You may have seen it by now. In a short, 15-second video, a nurse plays herself as well as a patient, who appears to be coughing and having trouble breathing. In the video, the nurse starts dancing and ignoring the patient.

The caption reads: “We know when y’all are faking.”

I have to tell you, it’s infuriating to watch.

I’m also wondering what she thinks would be the motivation to fake a cough. It’s not as though they typically treat coughs with pain medication. Is it because she thinks the patient just wants attention? Is that what’s happening?  

As a chronic pain patient who has been in and out of hospitals and doctor’s offices over the years, it’s my worst nightmare. To have a medical professional ignore me and my very real pain because they think they possess some special power that allows them to know with 100 percent certainty that someone is faking.  

I’m not alone in my outrage. The video inspired a viral hashtag, “PatientsAreNotFaking” with countless people sharing why the video wasn’t just annoying, but also dangerous.

Of course. I have my own stories. Doctors and nurses have brushed me off. There were the countless ER doctors who insisted that my multiple visits for abdominal pain were simply heartburn. One doctor even said to me, “It’s not your gallbladder.” 

It was my gallbladder.  

There was also the nurse who ignored my pleas for help after giving me a shot of pain medication that immediately made me nauseous. She told me to “drink some water” and sent me home instead of giving me an easy anti-nausea shot.

I threw up three times on the drive home and then multiple times for the next 10 hours. It was one of the worst nights of my life.  

And then there was the rheumatologist years ago who so easily could have caught my hypermobile Ehlers Danlos syndrome. I had gone to see him because of my unexplained rib pain, and as he examined me, he moved my leg, looked up and said, “Your knee isn’t supposed to bend that way.” Then he shrugged and told me that nothing was wrong with me.  

It would take four years before I finally got the hEDS diagnosis that explained my daily, debilitating chronic pain. 

But let’s take things one step further. Let’s enter the world of the video. Let’s assume patients are faking. So what? What’s the worst-case scenario? Medical professionals have to, God forbid, check in on a patient? Isn’t that their job anyway? 

This issue especially hits close to home for chronic pain patients. Every medical professional’s worst fear seems to be that they’ll give opioids to someone who just needs them because they’re addicted. And I have to ask, again, so what?  

Here’s the two scenarios if you give someone opioids in that situation: 

1. They aren’t faking and you’re helping someone who’s dealing with legitimate physical pain.

2. You’re giving a safe, controlled supply of opioids to someone who’s suffering from such awful withdrawal that they have resorted to trying to get to pain medication at an ER. Oh no! That might accidentally help someone? The horror!

Yes, giving pain medication to people dealing with addiction could lead to a flood of patients in the ER asking for opioids. Honestly, that’s why I support making hydrocodone OTC. It would keep people who are dealing with minor pain out of the ER, as well as those dealing with addiction and withdrawal. It might also prevent many of the overdoses caused by people buying counterfeit drugs off the street. 

The thing is, it’s human nature to assume someone is faking. It’s actually a defense mechanism. Medical professionals see so many sick people in their work that for many the only way they can cope is to convince themselves that most of them are probably faking. It’s much easier to believe that than it is to believe that so many people are suffering.  

The other issue is that people’s instincts are awful. They are often based on subconscious prejudice that they may not even realize is a factor. It’s human nature to separate yourself from other groups as a form of self-preservation. Unfortunately, that leads to a lot of medical professionals assuming that any patient complaining of pain is probably faking it. 

The fact that the nurse who made this particular video, Danyelle Solie, did nothing but double down when faced with criticism shows how poorly-matched she is her for job.  Solie told a Canadian website she’s worked in healthcare for five years.

“I absolutely will not be bullied into apologising or deleting a video because some people disagree with me,” she said in a Tweet thread. “Humor has always been what made me stand out to the people I work with and the patients I help.”

Solie regularly posts comical videos online using the name “D Rose.” Some videos make fun of herself and others make fun of patients or the healthcare system in general. The one about patients faking has been viewed about 15 million times. 

We should expect more from medical professionals. They should be able to wade past their subconscious instincts and make an effort to treat patients fairly. They also shouldn’t joke about such dangerous things.  

And when in doubt? Here’s some advice to all the medical professionals out there: Just assume the patient is telling the truth. Trust me, it’s what you’ll want when you get sick.  

Crystal Lindell is a journalist who lives in Illinois. She eats too much Taco Bell, drinks too much espresso, and spends too much time looking for the perfect pink lipstick. She has hypermobile EDS.  

U.S. Facing ‘Syndemic’ of Opioid Overdoses

By Pat Anson, PNN Editor

The U.S. opioid crisis is a lot more complex than many people think. Instead of a single “epidemic” fueled by prescription opioids, researchers say there are three types of opioid epidemics occurring in different parts of the country simultaneously.

A team of researchers at Iowa State University studied death certificate data from all 3,079 counties in the lower 48 states and found distinct regional differences in the opioids that caused the most overdoses.

Cities in New England have been hit hard by illicit fentanyl and other synthetic opioids; the Rockies and Midwest are plagued by heroin; and a prescription opioid epidemic still lingers in many rural counties in the South and West.

A fourth epidemic – dubbed a “syndemic” by researchers – involves multiple drugs and exists in counties where the opioid crisis first erupted, particularly in mid-sized cities in Kentucky, Ohio and West Virginia. 

About 25 percent of all U.S. counties fall into one of these epidemic categories.   

“Our results show that it’s more helpful to think of the problem as several epidemics occurring at the same time rather than just one,” said co-author David Peters, PhD, an associate professor of sociology at Iowa State University. “And they occur in different regions of the country, so there’s no single policy response that’s going to address all of these epidemics. There needs to be multiple sets of policies to address these distinct challenges.”

LEADING CAUSE OF OPIOID OVERDOSES

Overdose deaths linked to prescription opioids peaked nationwide in 2013 and have fallen in recent years. But researchers say some counties with poor economies continue to struggle with prescription drugs. Over one-third of the counties in Tennessee, Oklahoma, Nevada and Utah fall into this category.

“We find that prescription-related epidemic counties, whether rural or urban, have been ‘left behind’ the rest of the nation. These communities are less populated and more remote, older and mostly white, have a history of drug abuse, and are former farm and factory communities that have been in decline since the 1990s. Overdoses in these places exemplify the ‘deaths of despair’ narrative,” researchers reported in the journal Rural Sociology.

“By contrast, heroin and opioid syndemic counties tend to be more urban, connected to interstates, ethnically diverse, and in general more economically secure. The urban opioid crisis follows the path of previous drug epidemics, affecting a disadvantaged subpopulation that has been left behind rather than the entire community.” 

The study found heroin overdose deaths clustered along two major corridors, one linking El Paso to Denver and another linking Texas and Chicago. Those findings correspond with known drug routes used by cartels smuggling heroin into the U.S. from Mexico.

The study only looked at death certificate data up to 2016, missing the full impact of the CDC opioid guideline, as well as the widening scope of the fentanyl and counterfeit drug crisis. As PNN has reported, hundreds of people have died on the west coast this year after ingesting counterfeit oxycodone laced with fentanyl.

“We are waiting to obtain the 2017 and 2018 data from CDC, but I expect the number of Rx opioid epidemic counties have transitioned to the synthetic+Rx epidemic and the opioid syndemic,” Peters told PNN in an email. “Fentanyl mixtures are replacing Rx pills and heroin in many places, mainly because fentanyl analogs are cheap to produce and generate more profits for drug traffickers.”

Given the expanding nature of the opioid crisis, Peters and his colleagues say tighter regulation of opioid prescribing and dispensing will have little effect on overdoses. The same is true for law enforcement efforts to stop drug traffickers and smuggling.

Instead they recommend expanding access to addiction treatment, as well as long-term investment in struggling communities to reduce both economic despair and the demand for drugs.  

Severely Injured? Don’t Count on Getting Opioid Pain Medication

By Madora Pennington, PNN Columnist

When I went to Cedars-Sinai Urgent Care in Los Angeles recently, screaming and crying, my blood pressure dangerously high, my foot ballooning and turning blue from a household accident, the doctor wouldn’t give me opioid pain medication.

They x-rayed my foot. Two bones were broken. They gave me a shot of a NSAID that, they said, would wear off in a few hours. It did. They gave me crutches, a boot to immobilize my foot, suggested I see a surgeon and, in the meantime, take Advil. What?

It wasn’t personal. This is Cedars-Sinai’s policy. In urgent care, they won’t give opioids to anyone for any reason.

I had gone to Cedars-Sinai because I have a complex medical history. There, my records are most complete. This makes the appointment easier for the doctor and me.

Also in my records is my long-term opioid use history. I was on Vicodin and morphine daily for about six years, to treat chronic pain from Ehlers-Danlos syndrome, a rare genetic disorder that causes all the joints to be loose, or rather, permanently sprained.

When I started on daily opioids, an option no longer available, I had pain that I could not live with, no quality of life and was planning my suicide.

Those drugs gave me enough relief to endure. I became less of a burden to my caretaker. I could focus on trying to improve my health. If your day is spent fighting extreme pain, being productive is not possible.

Then I got very lucky.

In 2014, experimental treatment had improved the strength of my tendons and ligaments. My body hurt less. I went straight off the opioids and stayed off.

Withdrawal was a harrowing marathon of torture. For years after, I suffered from the physical damage opioids left behind. But I didn’t go back on them because I had never become addicted. Why? I had been warned at the start of my opioid treatment to take the drugs for physical pain only, not for emotional relief. This patient follows orders.

As a result of the war on opioids, many chronic pain patients are being denied adequate pain relief. Some forced to taper end up committing suicide from the agony of withdrawal plus untreated pain. This became such a problem, the U.S. Department of Health and Human Services issued new recommendations in October, advising doctors to look at each case individually and not to put patients on rapid opioid tapers or abruptly discontinue them.

But I had never heard of someone with a severe, acute injury forced to suffer. Even I can’t be trusted? I have a proven record of responsible opioid use with no addiction.

The doctor treating my injured foot, clearly embarrassed, told me, “This is urgent care. If it’s something severe, the patient should be in the ER or at a pain doctor.”

But I had called before I came. “Would they see me for a possibly broken foot?”

The receptionist said to come in, they would x-ray me right away. She didn’t say I would not be given adequate pain medication.

Has the war on opioids gone too far? If doctors and hospitals are too afraid of lawsuits or prosecution to prescribe, then yes.

A Mayo Clinic study found that only about 1% of patients given opioids in emergency rooms went on to long term use. Another study found less than 1% of patients being treated with opioids for post-surgical pain developed dependence or abused opioids. Does that mean the other 99% of us should not get pain medication?

Not according to the CDC, which suggests three days of opioids for acute injuries like mine.

After I left urgent care that day, I took Vicodin which had expired a year before but I’d never gotten rid of. If it hadn’t worked, I would have had to call an ambulance and gone to the ER that night, just for pain treatment.

After surgery, the podiatrist told me, “One bone was in pieces. I bolted together what I could. Some bits were too small so I picked them out and threw them away.” Well, that explains the pain I’d been in.

I vowed never to leave things on the floor that someone might trip on. And I set up Google Home to process a command to make a phone call for help.

I also filed a complaint with the state against the doctor. Medical care is about the patient, not hospital bureaucrats.

Madora Pennington writes about Ehlers-Danlos and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

Domestic Abuse Survivors Have Twice Risk of Fibromyalgia

By Pat Anson, PNN Editor  

Ava Shypula had a difficult childhood growing up in communist Poland. She was physically abused by her father and was left home alone for hours, sometimes days at a time. Ava became chronically ill at a young age. 

“My symptoms began very early, almost as far as I remember. They started with joint pain, chills and constant flu like symptoms, with a sore, inflamed throat,” Ava recalls. 

Even after marrying a doctor and leaving Poland to begin a new life in New York City, Ava’s symptoms persisted. 

“My then-husband ignored my symptoms, focusing on his own career and studying in order to re-certify his medical diploma,” she said. “The fear of failure, pride and ambition to succeed only advanced the illness, which at that time was diagnosed as chronic fatigue syndrome.” 

Only after her marriage ended in a nasty divorce did Ava begin to understand her illness and the role played by stress. She was diagnosed with fibromyalgia – a poorly understood disease characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. 

A neurologist prescribed Lyrica and Ava’s symptoms began improving. 

“For many years women with undiagnosed fibromyalgia had been dismissed as hysterics having emotional issues,” she said. “Together with a fantastic help from my psychiatrist, my symptoms slowly but noticeably diminished, not fully, but they have become more manageable.”

Abuse Causes Physical and Psychological Stress

Ava Shypula’s story is not unique. In fact, it is all too common, according to a large new study that found female survivors of domestic abuse have nearly twice the risk of developing widespread body pain and chronic fatigue syndrome (CFS).

Researchers at the Universities of Birmingham and Warwick in the UK examined the medical records of over 18,500 women who suffered domestic abuse and compared them to 74,000 women who did not. Health data was collected from 1995 to 2017.

The study, published in the Journal of Interpersonal Violence, is one of the first designed to assess the relationship between women who have been abused and the likelihood of them developing long-term illnesses such as fibromyalgia.

"Survivors of domestic abuse can experience immense physiological and psychological stress,” said Professor Julie Taylor of the University of Birmingham's School of Nursing. “The changes that happen in the body as a result of such stress can lead to a multitude of poor health outcomes such as what we see in our study here.

"This is a very complex relationship and it is important to emphasize that not all women who have been abused will develop fibromyalgia or CFS, and that having these conditions does not mean there has been domestic abuse in the past."

Previous research has found that about one in every four women in the UK have experienced some form of domestic abuse, with a large proportion of those cases being violence at the hands of an intimate partner. Globally, about one in three women suffer domestic abuse.

"Considering the prevalence of domestic abuse, and the fact that patients experiencing fibromyalgia and CFS often face delays in diagnosis due to a limited understanding generally of how these conditions are caused, it is important for clinicians to bear in mind that women who have survived abuse are at a greater risk of these conditions,” said Dr. Joht Singh Chandan of the University of Birmingham's Institute of Applied Health Research and Warwick Medical School.

"We hope these first of their kind research findings will change healthcare practice and will be of assistance in the early diagnosis of fibromyalgia and CFS in women who have been abused."

Ava Shypula hopes that sharing her story will help other women understand their illness, get treatment and make lifestyle changes to reduce stress. She’s learned that avoiding cold temperatures, staying warm and getting a good night’s sleep will reduce her symptoms. 

“Encourage them to fight back instead of resigning and living with pity and depression, which I have experienced at different points of my life,” she told PNN. “I have found that emotional support plays a major role to fight with this illness.”

Patient Who Can’t Find Doctor in Texas Flies to California for Pain Care

By Lori Ravellli, Guest Columnist

I am writing to ask for a change in attitudes toward people in pain who need improved access to treatment. I want my voice to be heard when actions are taken to curb the opioid abuse problem.

I need help. I suffer and have suffered for years from severe chronic lower back and coccyx pain that is unbearable. Some of the conditions I have been diagnosed with are chronic pain disorder, lumbar spondylosis, hypertrophic set arthropathy, degenerative disc disease, lumbar nerve root disorder and scoliosis. I honestly do not know what all of this means but I know how bad it hurts.

I also had a gastric procedure which limits the kinds of medications I can take, such as ibuprofen, muscle relaxers, naproxen and NSAIDs.

I have had multiple appointments with neurosurgeons and other doctors, who say I have too much wrong with my lower back to have any surgical procedure. I have stacks of reports and test results justifying my issues. I have had multiple injections with different medications and locations to drain my bank account, gain weight and still suffer in agony.

My only option is pain management through medication. I cannot sit down for any length of time and lying down hurts. I can only stand for so long without my legs giving out. In addition to that, I have shooting pain down my leg when I do sit.

Sadly, as much as a body needs rest, I can no longer rest comfortably. My quality of life is almost nonexistent due to the debilitating pain. Without relief, I really contemplate ending my life. I can no longer deal with the agony.

LORI RAVELLI

I do not want my friends and family to grieve because I took my life due to pain and lack of treatment. Chronic pain patients visit their doctors often, are subject to drug tests, and are not the reason there is a crisis in this country. Doctors being too scared to treat patients is not fair to us.

The problem is so bad here in Texas that doctors do not want to care for pain patients. I moved to Texas two years ago and have struggled to find care and treatment. I have been forced to fly back to my old doctor in California to get medication. My doctor I saw for many years knows me, knows I do not over-medicate, and has never needed to raise the dose of my medication.

I cannot believe that I am not able to find a doctor to treat me here in Texas. Sitting is so painful and it is a struggle to fly 3 hours for a doctor’s appointment. I have to sit in the car an hour, sit in the airport for 2 hours, and then the flight for 3 hours. Sitting is so painful because of my back and pain shooting down my leg.

By the time I arrive, I am in such horrific pain it takes days to recover. I am so tired of living in agony. This is so wrong and it is my human right to have some pain relief because it is available. 

The real problem seems be addicts that purchase medication from the streets and not knowing what they are purchasing. When people are not able to get their medication from the proper channels, they will seek options from the street with hope of finding some relief.

Pain relief is a human right and without relief people will take their lives. Living with debilitating pain you have no quality of life and no reason to wake up in the morning.

I am tired of being treated like a drug addict. I am suffering severely and need medication to be a functioning adult. I know I will never be pain free, but any relief is welcomed. Please, please for the love of God stop punishing the patients and the medical professionals trying to help them!

Lori Ravelli lives in Galveston, Texas.

Pain News Network invites other readers to share their stories with us. Send them to: editor@PainNewsNetwork.org. 

This column 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.

Opioids Are Not the Only Pain Meds That Can Be Abused

By Dr. Lynn Webster, PNN Columnist

Contrary to popular opinion, opioids don't cause substance abuse. Opioids certainly may be abused, but it is human biology itself that drives drug abuse.

We often get the message that any other pain treatment would be better than using opioids. However, even non-opioids prescribed for pain can contribute to overdoses and suicides. The same genetic and environmental factors that cause opioid abuse can induce abuse of other drugs, too.

For several years the number of opioid prescriptions has declined significantly, due to public demand and political pressure. According to the IQVIA Institute, there was a 17 percent decrease in the number of opioids prescribed in 2018 alone.

We may have expected that to translate into fewer drug abuse problems. Instead, we have seen an increase in overdoses, hospitalizations and suicides involving non-opioids such as gabapentin, methamphetamines and muscle relaxants.

Less access to prescription opioids has driven some people in disabling pain to seek illegal alternative medications. That has led to a wave of use and abuse of drugs that doctors have not prescribed.

Between 2016 and 2017, the CDC reported a nearly 47% increase in fentanyl-related deaths. Overdoses related to methamphetamine and cocaine have also surged.  

According to Stateline, approximately 14,000 cocaine users and 10,000 meth users died in the United States in 2017, triple the number of deaths in 2012. Deaths involving have heroin also spiked since 2010.  

Gabapentin and Baclofen 

Prescription drugs, too, have fueled the negative statistics. Doctors have felt forced to taper or discontinue opioids. In an attempt to find alternatives for pain management, they have increased the number of gabapentin and baclofen prescriptions. 

As PNN has reported, a recent study published in Clinical Toxicology found a “worrying” increase in calls to U.S. poison control centers about gabapentin (Neurontin) and the muscle relaxer baclofen, coinciding with a decrease in opioid prescriptions. The study analyzed more than 90,000 cases of exposure to gabapentin and baclofen, many of which were coded as suicides or attempted suicides.

“Gabapentin and baclofen are two medications that have seen increased availability to patients as alternatives to opioids for the treatment of acute and chronic pain. With greater accessibility, poison center exposures have demonstrated a marked increase in toxic exposures to these two medications,” wrote lead author Kimberly Reynolds of the University of Pittsburgh.

“As poison center data do not represent the totality of cases in the United States, the steep upward trends in reported exposures reflect a much larger problem than the raw numbers would suggest.”  

Gabapentin is one of the most commonly prescribed drugs in the United States. It is prescribed for epilepsy, hot flashes, migraines, nerve damage, and more. It is also used to treat the symptoms of drug and alcohol detoxification, and to treat pain for patients at higher risk of addiction to opioids.  

Baclofen is a muscle relaxant that has also been substituted for opioids. Other non-opioid drugs such as pregabalin and NSAID’s are being increasingly prescribed as well.  

All Medications Have Risks 

Non-opioids have a role to play in pain management, but it is just as important to understand their dangers. While we need effective alternatives to opioids, it is important to know that alternatives also have risks. That is unavoidable, because all medications carry potential benefits and consequences.  

To decide whether a medication is appropriate for an individual, it is critical to determine whether the potential benefit outweighs potential harm. Gabapentin and baclofen are not bad drugs, but they are not harmless replacements for opioids, either.  

No pain medication, whether it is an opioid or non-opioid, is right for everyone under all circumstances. The next time a physician or nurse practitioner suggests replacing an opioid with gabapentin, baclofen, or another medication, it would be appropriate to ask for a comparison of the risks and benefits. 

Talking with your healthcare provider about your preference for a particular medication does not make you a drug seeker. It helps you become an informed patient. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is the author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find Lynn on Twitter: @LynnRWebsterMD.

Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences. 

FDA Approves Generic Gilenya for Treatment of MS

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has approved the first generic versions of Gilenya (fingolimod) for the treatment of relapsing forms of multiple sclerosis (MS). That’s welcome news for patients who have long struggled with the exorbitant cost of many MS medications.

A 30-day supply of Gilenya 0.5mg capsules currently costs about $8,130, according to Healthcare Bluebook, or about $97,560 a year.

“Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines.”

The FDA approved generic fingolimod applications from HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited.

Until now, Novartis held the exclusive patent rights to fingolimod, which is sold under the brand name Gilenya. Nearly 300,000 people worldwide have taken Gilenya since it was approved by the FDA in 2010, according to Novartis.

MS is a chronic and progressive disease that attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain. For most people with MS, there are periods of remission followed by relapses or flareups as the disease progresses. Gilenya is a widely used treatment for relapsing MS.

Generic formulations are often significantly cheaper than brand name drugs. In July, the FDA approved the first generic forms of Lyrica. Today a two-month supply of Lyrica costs about $472, while the same amount of generic pregabalin costs just $21.

Maximizing Profit

Criticism about the high cost of branded MS drugs is growing. Last month when the FDA approved a new MS medication called Vumerity, drug maker Biogen set its wholesale price at $88,000 a year. That brought a rare rebuke from the National Multiple Sclerosis Society, which released a statement that accused Biogen of price gouging.

It can take years for a new drug to get FDA approval and the pharmaceutical industry has long claimed that it needs to set prices high to recover the cost of research, clinical studies and drug development.

That claim is discounted in a recent article published in the journal Neurology, in which researchers asked four drug industry executives about the high cost of MS drugs. The executives were given anonymity to encourage them to speak freely.  

"I would say the rationales for the price increases are purely what can maximize profit," one executive said. "There's no other rationale for it.”

In setting the price for a new drug, executives said they primarily look at what their competitors are charging for similar medications. Companies fear that undercutting competitors with a lower price would undermine the attractiveness of their product.

"We can't come in at less," one of the executives said. "That would mean we're less effective, we think less of our product, so we have to go more."

The problem is unique to the United States, the only developed country that doesn’t have a universal healthcare system that regulates prices.

"And it is only in the United States, really, that you can take price increases. You can't do it in the rest of the world. In the rest of the world, prices decline with duration in the marketplace," another executive said.

Researchers say their study provides new insight into the economics behind pharmaceutical pricing.

"The frank information provided by these executives pulls back the curtain of secrecy on how drug price decisions are made," said co-author Dennis Bourdette, MD, chair of neurology at the Oregon Health & Science University School of Medicine. "We see that it is indeed the race to make more money that is driving up drug prices and nothing more."

In the meantime, MS patients like Jennifer Hochgesang struggle to make their co-payments and deductibles. She gets injections of glatiramer acetate, a generic version of Copaxone.

“It costs over $5,500 a month. When you add my migraine medication and other medications, it adds up to over $13,000 a month. I reach catastrophic level by March in my insurance and that’s the only way I can pay for it,” Hochgesang said. “It doesn’t cost that much in Europe though and it shouldn’t cost that much here.

“It seems sick to me that companies use a drug like this to profit highly from, when people can’t reasonably afford five thousand dollars a month. I believe an MS drug should be accessible to anyone. Otherwise we are only creating medicine for the rich and those able to get insurance or be on disability, leaving the rest out in the cold. That just isn’t right.” 

Living Well With Fibromyalgia

By Lynn Phipps, Guest Columnist

In 2016, as a guest columnist for PNN, I shared my story of being diagnosed with fibromyalgia and the offending ways I was treated by the medical community for having an invisible illness.

If my first column was about finding hope, then this one is about getting well and living well with fibromyalgia. I hope that you will be inspired by my story and know that there is a way for you to reclaim your lives from the devastating illness that is fibromyalgia.

For years I felt alone. I am not alone. Neither are you.

In 2003, I knew something was very wrong when I could no longer effectively do my job as a social worker. ​I was in constant pain, had a 24/7 headache and migraines twice a week or more, and could not fully concentrate. Insomnia and anxiety had me awake most nights.

Desperate to get well, I spent half of my paycheck on herbs, supplements, massage, hydrotherapy, acupuncture, chiropractic, ​Rolfing​and Reiki​. Nevertheless, I continued getting worse. When I could no longer afford alternative treatments not covered by my health insurance, my body crashed.

Having suffered from unrelenting migraines for months, my final career ending moment came when my back and neck spasmed, causing me to fall to the floor in my office at work. I remained on hands and knees for 20 minutes before being able to crawl to my desk to pull myself up.

I do not remember driving home, nor did I realize that moment signaled the end of my 20-year career as a social worker caring for those with disabilities (ironic, I know).

I was diagnosed by my doctor with fibromyalgia, chronic pain, severe headaches and migraines, light and sound sensitivity, depression, insomnia, anxiety and PTSD. 

The Guaifenesin Protocol

LYNN PHIPPS

Over the next decade, it became my job to research and find help for my condition. The problem was that none of the specialists looked at fibromyalgia as a cause for all that I was experiencing. And not one physician ever looked at food allergies or diet as a potential cause, even though I have a family history of diabetes.

That is significant because 44% of “fibromyalgics” also have a second and separate disease called hypoglycemia.  Another 15% of fibromyalgics have hypothyroidism, another disease with overlapping symptoms, including fatigue, muscle pain and impaired memory, to name just a few. I am unlucky enough to have this grand trifecta of illness. 

With nearly all hope gone, an internet search for headache specialists in northern California led me to Dr. Melissa Congdon, a fibromyalgia specialist. ​​It was through her that I finally understood that the headaches and migraines were related to the fibromyalgia, and not whiplash from a car accident or a repetitive motion injury from work, as every doctor and specialist had assumed. 

During my first appointment, my fibromyalgia diagnosis was confirmed by Dr Congdon. I was also diagnosed with hypoglycemia. Again, this is significant because about half of us with fibromyalgia also have hypoglycemia, with overlapping symptoms such as fatigue, pain and impaired memory.

In order to get our health back, these two separate diseases require two separate treatments: Dr R. Paul Saint Amand’s Guaifenesin Protocol and his HG Diet for fibroglycemia.,

The protocol requires taking the expectorant drug guaifenesin (Mucinex), which clears airways in the lungs and helps the kidneys reduce the buildup of inorganic phosphates in the body. The low-carbohydrate diet combats low blood sugar, which mimics many fibromyalgia symptoms.

Within 2 months of following the protocol and diet, I began to see improvement in generalized body pain, headaches and migraines, chronic fatigue and brain fog. After 20 months, I got “me” back, and so did my family. 

Many people have mentioned that they do not want to follow the protocol because they have heard that it will make them feel worse. To this we say, “It’s pain with a purpose.”  We strive for finding our own individual dose of guaifenesin that will leave us “functionally” worse, not incapacitated. As long as we do nothing, the phosphates will continue to accumulate throughout the body, causing fibromyalgia symptoms to continually worsen.

The Guaifenesin Protocol will clear the offending phosphates from our kidneys at a rate of approximately​ ​1 year of symptoms in just 2 months. I was symptomatic for 10 years before starting the protocol and had reversed all of my symptoms within 20 months. By the first year on the protocol, I was off of all pain medication. 

My Awakening

The 13 years that I spent bed-bound seem like a bad dream. It was quite an adjustment getting my health back after so much time. It felt as if I’d been existing in a semi-comatose state. While I’d been so ill, my mother passed from pancreatic cancer and both daughters moved out, graduated from college and started their adult lives. 

I had physically been there for all of that, but with such severe fatigue and brain fog, it all had a feeling of unreality to me. Upon “awakening” I was shocked by my appearance, as I’d been only 38 when I got sick and had “awakened” at age 51. My husband and I had to get to know each other all over again. Luckily, we fell in love all over again. 

After the brain fog and severe fatigue had cleared, I wanted to go back to work, but I knew that I could not be a social worker again. Many fibromyalgia symptoms are brought on by physical or emotional trauma. The stress of being a social worker ruled that out, so I decided to do something quite different. I put my years of watching HGTV while bedbound to use by becoming certified in home staging and redesign.  I enjoyed a successful home staging business for 3 years before retiring.

I now spend my days educating others on the Guaifenesin Protocol, helping those still suffering from fibromyalgia get their lives back, too.

(Editor’s note: For a contrarian view on the Guaifenesin Protocol, click here.)

Lynn Phipps lives in northern California. Lynn has created a website called Living with Fibromyalgia to assist beginners in getting started on the Guaifenesin Protocol.

Pain News Network invites other readers to share their stories with us. Send them to: editor@PainNewsNetwork.org. 

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.