Injectable Gel Could Help Knee Cartilage Heal

By Pat Anson, Editor

With the number of knee replacement surgeries soaring in the United States, researchers at the University of Iowa are working on an injectable gel that could repair damaged cartilage and make many knee surgeries unnecessary.

"We are creating an [injectable, bioactive] hydrogel that can repair cartilage damage, regenerate stronger cartilage, and hopefully delay or eliminate the development of osteoarthritis and eliminate the need for total knee replacement," says Yin Yu, a graduate student at the University of Iowa (UI) whose study is featured in the journal Arthritis and Rheumatology.

Osteoarthritis (OA) is a joint disorder that leads to thinning of cartilage and progressive joint damage. Nearly 40 percent of Americans over the age of 45 have some degree of knee OA, and those numbers are expected to grow as the population ages.

About 600,000 knee replacement surgeries are performed annually in the U.S. – about twice the number performed 20 years ago. Recent studies have questioned whether many of the surgeries are appropriate.

UI researchers have previously identified precursor cells in healthy cartilage that can mature into new cartilage tissue – a surprising development given the long-held assumption that cartilage is one of the few tissues in the body that cannot repair itself.

The researchers also identified molecular signals that encourage precursor cells to migrate out of healthy tissue and into damaged areas – stimulating the development of new cartilage. One of the signals, called stromal cell-derived factor 1 (SDF1), acts like a “homing beacon” for the precursor cells.

In an experimental model of cartilage injury, Yu loaded the hydrogel with SDF1 and injected it into holes punched into the model cartilage. The precursor cells migrated toward the SDF1 infused gel and filled in the injury site. Subsequent application of a growth factor caused the cells to mature into normal cartilage that repaired the injury.

The new tissue is not as strong as normal cartilage, but researchers think it could be strengthened through physical therapy and exercise.

"There's really no cure for osteoarthritis except for total joint replacement, which is not particularly suitable for younger patients because the artificial joints wear out and need to be replaced multiple times," said James Martin, PhD, a UI assistant professor of orthopedics and rehabilitation who leads the research team.

"Our approach aims to leverage the body's own capacity for repair, and what we've shown is that cartilage does have regenerative potential; you just have to manipulate it just right."

UI Researchers are now looking at different ways to include the growth factor in the hydrogel – possibly by using nano-size plasmids that carry genetic instructions for the growth factor or microspheres loaded with the substance.

Yu and Martin plan to start animal trials within a year and, if the results are promising, begin human trials in about five years.

Injections of platelet rich plasma (PRP) into the knee also show promise in the treatment of osteoarthritis, according to a recent study published in The Journal of the American Osteopathic Association (JAOA).

Only a few small clinical trials have been conducted on the effectiveness of PRP therapy. Researchers at the University of Miami Miller School of Medicine analyzed those trials and found that patients with knee osteoarthritis and other musculoskeletal injuries showed significant improvements as long as two years after PRP injections.

The procedure involves withdrawing blood from the patient and then spinning it to produce a high concentration of platelet cells. The plasma is then injected back into the patient at the injury site, speeding up the healing process. Several top athletes, including Kobe Bryant and Peyton Manning, have used a form of PRP therapy to help them recover from injuries.

A Pained Life: The Balancing Act

By Carol Levy, Columnist

It is time for a renewal for my pain meds but I have a number of pills left.  I was excited for a few seconds. Maybe the pain has been better so I need fewer pills!

And then I thought about it a little bit more.

It is not because the pain has lessened.  

I realized I have stopped doing a lot of what I used to do.  It was not the pain that had backed off. It was a reduction in my willingness to do things that trigger pain.

I had been working on a line of greeting cards that I both wrote and illustrated. I had also created a doll and made pins of the character that had her jogging, playing the trumpet, skating and more. I had hoped to learn to sew and bring the doll to market.

Looking back, I realized I stopped working on all of it a few months after my brain implant stopped working.  I had not realized it had been helping reduce the pain. 

I still had the eye usage and movement pain that caused me to be unable to do any consistent eye work for more then 15 - 20 minutes -- before the severe and often unrelenting pain started.

Apparently, the stimulator had reduced the anesthesia dolorosa (phantom pain) in the left side of my face. And now that it had failed, the weight of small plastic glasses or the use of facial muscles (tight as a result of facial paralysis) set off pain again.

I had moved from my house to a small apartment.  Well heck, that‘s why I’m not doing things. No room to do my crafts and art.

That made sense, except I had stopped before I sold the house, when I had an entire room devoted solely to my art and crafts work.

So what stops me?

The pain, of course.  But it is also the fear of pain.

The thought occurs: I need to work on the doll, the cards, even this column, and immediately the next thought comes: But then it will set off the pain, or make it worse if it is already in play.

It is a game of balance and juggling.

Do I give up on the things that make me happy, give me a sense of accomplishment and purpose, because the pain will be bad, even unrelentingly bad?

Or do I give up? 

Lately my choice has been the latter, maybe not consciously, but a choice nevertheless.

At what point and how do we make the choices balance out? 

I wish I knew.

I only know that right now, for me, the pain is doing the choosing for me.

It is a decision most of have to make at some point.  Can we master the pain or does pain become the master of us?

Maybe, as long as we do not make it a permanent decision, it is okay now and then to give in to the pain and the fear.  Maybe it is a healthy way of taking care of ourselves.  Not a capitulation, but a short term concession.

And that is not always such a terrible thing.

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.

Better Sleep Means Less Pain

By Pat Anson, Editor

Getting a good night’s sleep plays a key role in determining how bad your pain levels are doing the day, according to a large new study by researchers in Norway.

The study included more than 10,400 adults from an ongoing Norwegian health study. Each participant underwent a standard test of pain sensitivity -- the cold pressor test -- in which they were asked to keep their hand submerged in a cold water bath for 106 seconds.

Only 32% of participants were able to keep their hand in cold water throughout the experiment. Those who suffered from insomnia were more likely to take their hand out early: 42% did so, compared with 31% of those without insomnia.

Pain sensitivity also increased depending on the frequency of insomnia. Those who had trouble sleeping at least once a week had a 52% lower pain tolerance, while those who reported insomnia once a month had a 24% lower tolerance for pain.

"While there is clearly a strong relationship between pain and sleep, such that insomnia increases both the likelihood and severity of clinical pain. It is not clear exactly why this is the case," wrote lead author Børge Sivertsen, PhD, of the Norwegian Institute of Public Health.

The study, which is published in the journal PAIN,  is the first to link insomnia and impaired sleep to reduced pain tolerance in a large, general population sample. The results suggest that psychological factors may contribute to the relationship between sleep problems and pain, but they do not fully explain it.

“We conclude that impaired sleep significantly increases the risk for reduced pain tolerance. As comorbid sleep problems and pain have been linked to elevated disability, the need to improve sleep among chronic pain patients, and vice versa, should be an important agenda for future research,” the study said.

A previous study in Norway found that women who have trouble sleeping are at greater risk of developing fibromyalgia – although it’s not clear if there’s a cause and effect relationship between the two symptoms.

Another study, recently published in PLoS One, found that insomnia – not surprisingly – made chronic pain patients less likely to exercise. Researchers followed 119 chronic pain patients, most of whom suffered low back pain, and found that quality of sleep was the best predictor of physical activity the next day – not mood or pain intensity.

Why You Should Consider Medical Marijuana

(Editor’s note: Pain News Network is pleased to welcome Ellen Lenox Smith as our newest columnist. Ellen has suffered from chronic pain all of her life, but it wasn’t until a few years ago that she discovered the pain relieving benefits of medical marijuana. In future columns, Ellen will focus on marijuana and how it can be used as pain medication. Medical marijuana is legal in 23 U.S. states and the District of Columbia. But even in states where it is legal, doctors may frown upon marijuana and drop patients from their practice for using it.)

By Ellen Lenox Smith, Columnist

Why -- at the age of 57 -- would one ever consider turning to medical marijuana? 

I wondered the same thing after being sent to a pain doctor just before another surgery in 2006. After reviewing my records and seeing that I was unresponsive to pain medication, the doctor clearly had no idea what to suggest, except trying medical marijuana. 

I was born with Ehlers Danlos syndrome and later also added sarcoidosis to my life. I was living with chronic pain that was preventing me from sleeping, thinking straight, and functioning.

From birth, I had one issue after another reacting to medications. And after 22 surgeries, you can imagine the horror of all I had to endure and the added pain of never knowing the proper relief my body could have from pain medication. Eventually, a DNA drug sensitivity test was ordered and it confirmed I could not metabolize most drugs. This meant no aspirin, Tylenol, or any opiates. 

I took the advice to try medical marijuana with tremendous trepidation. At that time in Rhode Island, you either had to grow your own or buy it on the black market.  Since growing takes about three months, I decided the only way to find out what marijuana would do for me was to find a source and give it a try. 

ELLEN LENOX SMITH

When I was able to find some marijuana, I ground it up, heated up some olive oil and let it release the medicine into the oil. I had no choice, since I was told by a pulmonologist that smoking marijuana with sarcoidosis in the chest would be fatal. I wanted to try a different way to administer it.

That night, I measured out one teaspoon of the infused oil. I mixed it with some applesauce and one hour before bedtime, I swallowed it down. I remember being scared -- for I am not one that likes to be out of control of my body. Having smoked marijuana once in college, I hated that sensation. 

As soon as I took the dose, I went to my husband and warned him that I had taken marijuana and to keep an eye out for me. I was convinced this was a stupid thing to be doing and I would be stoned all night.

One hour later, we got in bed, I closed my eyes and before I knew it, it was morning. I had slept the whole night, never waking up once!

I woke up refreshed, not groggy, and ready to take on life again. I had no “high” or stoned sensation like you would guess would happen. 

I learned quickly that someone in pain does not react the same way to cannabis as someone who uses it for recreational reasons. The brain receptors connect with the THC and cannabinoids (the active ingredients in marijuana), and provide safe and gentle pain relief.

I was shocked and thrilled with the result. My husband and I quickly got to work setting up a legal way to grow marijuana. I realized that life was directing us to new topic we just had to advocate for. 

If I was scared to try marijuana, there is no question that others felt the same way -- and we had to let them know how amazing it really is. Society brought us up to be negative about marijuana, yet it was used in our country many years ago and even sold in pharmacies. The success of this medication was squashed, and we were all led to believe that it was bad and dangerous.

What we learned is that no one dies from using marijuana, no one develops organ damage, and with a body in chronic pain -- you can regain your life back. 

Are my conditions cured? No, they are both incurable. But I have been able to advocate, think, feel and live again thanks to using medical marijuana. 

Don’t be scared. Consider how much safer this medication is than all the other pain relief choices out there. Turn your body and your life with pain around. You won’t regret it.

Ellen Lenox Smith and her husband Stuart live in Rhode Island. They are co-directors for medical marijuana advocacy for the U.S. Pain Foundation and serve as board members for the Rhode Island Patient Advocacy Coalition. For more information about medical marijuana, visit their website. 

If you have a question for Ellen about medical marijuana, leave a comment below or send it to editor@PainNewsNetwork.org.

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.

When Nobody Believes You

By Jennifer Martin, Columnist

“It’s all in your head.”

“Your doctors are wrong.”

“You don’t really feel as bad as you say you do.”

“You must not really be in that much pain because you look fine.”

These words are far too common in the ears of chronic pain patients.  They can make one feel isolated, alone, and as if nobody cares.

One of my patients told me the other day, “My husband doesn’t believe I’m in as much pain as I say I am.  He thinks it’s all psychological.” 

A week earlier, a friend told me, “No matter how many doctors and specialists I have been to, my family still does not believe my diagnosis.  They think it is wrong.  I feel like I have to hide my pain around them.”

I listen to story after story from patients and friends with chronic pain stating the same thing: that family members, friends, doctors, co-workers, teachers, etc. do not believe they are in as much pain as they say they are. Often it’s because they look fine on the outside. 

They have told me they feel like they are whining about their pain, that people just brush them off or that they feel guilty for even talking about their pain.

They ask me, “What’s the point? I feel like nobody believes me anyway.”

No matter how many times I hear these stories, it still angers me.  Chronic pain is not something that anyone should feel like they have to convince another person of.  It is not something to feel guilty about and it is not something anyone should feel like they have to hide -- especially from those closest to them.

Unlike having diabetes, cancer or a broken arm, most people do not understand chronic pain and the effects it has. And many who think they understand are misinformed.

What they often don't understand is that chronic pain sufferers don’t always look sick.  Because their pain is chronic, they have learned to go on and live their daily lives to the best of their ability.  Just because you can’t physically see someone’s pain, that doesn’t mean it is all in their head and it doesn’t mean they are fine.  

And being told that their doctor must be wrong or that they should hide their pain only makes things worse. 

When someone is diagnosed with chronic pain, they want more than anything for that diagnosis to be wrong.  However, more times than not, the diagnosis they receive, especially if they have been to multiple doctors, is correct.  After the shock and denial has worn off, that patient, more than anything, is going to need support and acceptance, not criticism and disbelief.

Being diagnosed with a chronic condition is life changing, even for the strongest individuals.  It means finding a new normal, contending with things that are unimaginable and going through life feeling like those closest to you will never understand.  

It means trying to make sense of this new person they have been forced to become and the new reality they are now living.  All of these things could be managed just a little easier by hearing the simple words, “I believe you.”

Jennifer Martin, PsyD, is a licensed psychologist in Newport Beach, California who suffers from rheumatoid arthritis and ulcerative colitis. In her blog “Your Color Looks Good” Jennifer writes about the psychological aspects of dealing with chronic pain and illness.

Jennifer is a professional member of the Crohn’s and Colitis Foundation of America and has a Facebook page dedicated to providing support and information to people with Crohn’s, Colitis and Digestive Diseases, as well as other types of chronic 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.

National Pain Strategy: A Rough Beast?

(Editor’s Note: Earlier this month, The National Institutes of Health (NIH) released a draft copy of its National Pain Strategy, a long awaited report designed to advance pain research and healthcare in the U.S. The report identifies several areas where the healthcare system is failing pain sufferers and how it can be improved

A coalition of 17 chronic pain organizations called the Consumer Pain Advocacy Task Force was quick to endorse the National Pain Strategy, and is now lobbying the NIH to create an oversight body to implement the plan and provide funding for it

David Becker is a social worker, patient advocate and political activist who believes the needs and concerns of pain sufferers are not adequately addressed by the National Pain Strategy.)

By David Becker

The Consumer Pain Advocacy Task Force started promoting the National Pain Strategy (NPS) less than a week after it was made public. Obviously they didn't wait to hear from their members or people in pain -- as they are intent on seeing that rough beast of a plan be born no matter what people in pain think or want. The NPS is not "urgently needed" as they claim.

The NPS did not put a price tag on any of its plans or estimate how much their plan might save in costs; or how much the prevalence of painful conditions might be lowered or how much incidents of healthcare disparities might be reduced.

It is clear the government didn't want to include clear performance measures in the NPS. They do not wish to be held accountable to Americans or people in pain if the plan doesn’t work.

I do not support this thinly veiled occupational strategy that serves special interest groups without regard to the public good. Like a box of chocolates -- you don't know what you’re getting with this plan. 

DAVID BECKER

It is a big lie to say that the biopsychosocial model or interdisciplinary care meets the evidence based pyramid standards. Not enough research on their paradigm has ever been done and what little there is does not provide strong evidence for their paradigm over treatment as usual.

This plan has failed to learn from the mistakes of the past. A decade of pain control and research was a failure. It based its efforts on the “experts” -- as does the NPS. The more things change in pain care the more they remain the same. And people in pain remain condemned to the failed strategies of the past. The NPS, essentially, is nothing new.

It is clear that the 80 people who created the NPS don't have "the right stuff.” They have left too much to the imagination with their plan and leave out any plan for multi-morbidity or for treatment burden, and don't allow for an ongoing dialogue with people in pain.

To paraphrase Immanuel Kant, “We can think what we want, as long as we obey.”

The NPS was not a conversation with people in pain. It is a top down reductionist strategy by special interest groups to maintain their power and prestige. It will do very little for people in pain or address the ever rising economic burden of poor pain care.

As Helen Keller wrote, it is a terrible thing to see with no vision. The NPS fails to see much of the problems in pain care, failed to listen to the dried voices of people in pain, and offers no inspiring vision to address the many problems in pain care. The NPS is one rough beast that slouches toward Bethlehem and should never be born.

It is tragic that America can’t get it right when it comes to pain care. The politicos are anti-democratic and too ignorant of the real problems to create a sophisticated model or plan for dealing with pain.

My official comments to the NPS will excoriate their claims to expertise and their claims that they care about pain in America. But no article or comments will stop this rough beast from being born – too many organizations have been working hard to make it a reality.

What do you think? You can read the National Pain Strategy for yourself, by clicking here.

The NIH is accepting comments on the NPS until May 20, 2015.

Written comments can be emailed to NPSPublicComments@NIH.gov. They can also be addressed by snail mail to Linda Porter, NINDS/NIH, 31 Center Drive, Room 8A31, Bethesda, MD 20892.

Doctor Defends Use of Urine Drug Tests

By Pat Anson, Editor

A prominent pain doctor is disputing reports that a widely used urine drug test often gives faulty results.

“They are reasonably reliable and highly cost effective for use in a pain management practice. I would strongly recommend the practitioners use this,” said Laxmaiah Manchikanti, MD, chairman and CEO of the American Society of Interventional Pain Physicians.

Dr. LAXMAIAH MANCHIKANTI

Dr. Manchikanti, who is medical director of a pain clinic in Paducah, Kentucky, was the lead author of a study published in the journal Pain Physician in 2011, which looked at the reliability of immunoassay “point-of-care” (POC) tests. The urine tests are inexpensive and give immediate results, and doctors often use them to monitor their patients for opioid or illicit drug use.

“The UDT (urine drug test) with immunoassay in an office setting is appropriate, convenient and cost effective. Compared with laboratory testing for opioids and illicit drugs, immunoassay office testing had high specificity and agreement,” Manchikanti's study found.

Pain News Network recently reported on the results of a second study conducted by Millennium Health, a San Diego-based drug testing laboratory, which found that POC tests were wrong about half the time – frequently giving false positive and false negatives results for drugs like marijuana and oxycodone. The Millennium study advocates the use of chromatography-mass-spectrometry – a more complex laboratory test that costs thousands of dollars – to confirm POC test results.

“Following the advice from companies in reference to numerous expensive tests and also income generating avenues will only lead to time in the slammer and will not improve patient care at all,” said Manchikanti.

“(The) Millennium study is performed by the company which makes a living by testing. The more samples that are sent to them, the better off they are. Further, they are not even a practical setting. From our practice we send approximately only 2% of the samples for confirmation testing. Even then, the patients can’t pay their bills.”

Manchikanti’s study found false negative and false positive rates for POC tests that were far below the rates reported by Millennium.

For example, Millennium’s false positive rate for oxycodone was 41.3 percent. For Manchikanti, it was only 7.7 percent.

Millennium’s false positive rate for marijuana was 21.3 percent. For Manchikanti, it was just 2 percent.

There were discrepancies between the two studies for several other drugs, including methadone, cocaine and methamphetamine.

Millennium Sponsored Both Studies

How could two studies come to such different conclusions?

There were some differences in their design. Urine samples in the Millennium study came from nearly 4,300 patients in addiction treatment clinics, while the urine samples in Manchikanti’s study came from 1,000 patients in pain management programs. Millennium maintains the patients in its study were younger and more likely to be drug users.

Ironically, the laboratory tests for both studies were conducted by Millennium – which collected samples and provided chromatography-mass-spectrometry testing at no cost to Manchikanti. Millennium is identified as the “sponsor” of Manchikanti’s study, but he says the company had “no influence or interference” in his and his three co-authors’ findings.

“We had our agreement in the beginning itself that they will not be involved in any way in writing the manuscript or publishing the results. Consequently, they really did not have much input into the publication. The publication was as it is and without any bias from the industry,” Manchikanti wrote in an email to Pain News Network.

Millennium’s study, which was published last year in the Journal of Opioid Management, had six co-authors. All but one were employees of the company. The lone exception is a pain management doctor who frequently testifies as a legal expert for Millennium in court cases.

A source with broad experience in the drug testing industry told Pain News Network the data in Millennium’s study was “skewed toward exaggeration.”

“It does not surprise me that Millennium would show a high rate of inconsistencies with the POC test. Remember, their business is to sell confirmation testing, so they will skew the way they present data to try to influence the market to do more confirmation testing.  In most cases, that’s how it works in any study conducted or funded by a device or pharmaceutical company,” the source said.

Millennium bristles at the notion that its study was biased.

“Millennium Health strongly disagrees with the characterization… that the study was skewed or biased in any way,” the company said in a statement to Pain News Network.

“The study was accepted and published by a well-respected, peer-reviewed publication. Millennium Research Institute is committed to the highest ethical and research science standards, and we stand by the results of our study. The study was based on random samples from addiction treatment clients. The data clearly indicated that immunoassay, or point-of-care, tests have a high rate of false positives and false negatives when used to screen patients for illicit drug use.

“Millennium is committed to providing data that helps clinicians evaluate the best course of treatment for patients with pain and addiction issues. Millennium Health performs only the tests ordered by clinicians.”

In recent years a growing number of doctors who treat addicts and pain patients have required them to submit to drug tests. The competition between Millennium and other laboratories for this business is intense. According to one estimate, drug testing has grown into a lucrative $4 billion dollar a year industry.

But Manchikanti maintains that a single inexpensive urine test that costs about $20 is often the only one that’s needed.

“If a proper (patient) history is provided which matches with the test, there is no need for further testing,” he said.

FDA Order Stops Production of Medtronic Pain Pump

By Pat Anson, Editor

The U.S. Food and Drug Administration has filed a court order against medical device maker Medtronic ordering it to cease production and distribution of its SynchroMed II pain pumps.

Defects in the surgically implanted pumps, which are used to treat patients with chronic pain, cancer and severe muscle spasms, have been blamed for over a dozen deaths. The devices either lost power or inadvertently injected patients with too much or too little medication. The pump delivers analgesic drugs directly to the spinal fluid of pain patients.

Under the FDA's consent decree with Medtronic, the company will stop production of the SynchroMed II pump at its manufacturing plant in Columbia Heights, Minnesota. Medtronic will also retain a third-party expert to help develop and submit plans to the FDA to correct manufacturing and design problems. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions of the consent decree.

The FDA first approved the SynchroMed II pumps in 2004. Between 2006 and 2013, FDA investigators conducted five inspections at Medtronic’s production facilities, resulting in three warning letters notifying the company of major violations. The violations included inadequate processes for identifying quality control problems, failure to document design changes, and failure to ensure that finished products meet design specifications.

“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” said Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”

Over 200,000 SynchroMed pumps have been implanted worldwide, according to Medtronic, but the devices are not being recalled. Patients who experience a sudden change in their pain levels or hear a device alarm are being urged to contact their physician immediately.

“The agreement does not require the retrieval of any Medtronic products. With this announcement there is no new information to share about the safety and performance of the SynchroMed drug infusion system. Patients with the SynchroMed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement,” the company said in a statement.

"We are committed to the highest level of quality, and have pursued significant efforts in recent years to enhance the performance of the pump and to address the FDA`s expectations," said Tom Tefft, senior vice president and president of Neuromodulation, which is part of the Restorative Therapies Group at Medtronic.

Miss Understood: Surgery is a Big Deal

By Arlene Grau, Columnist

A few weeks ago I had my first scheduled surgery, a synovectomy of the right wrist, to repair some of the damage caused by rheumatoid arthritis to my wrist joint.

I've had numerous surgeries in the past, but none before were the result of my auto immune diseases. I was first diagnosed 7 years ago, at the age of 22.  

It wasn't until I met with my orthopedic surgeon that I realized this may be the first of many surgeries I may need. I just didn't expect to need one when I was still in my 20's.

I guess you could say that there are many misconceptions when it comes to what pain sufferers have to endure and what the timeline is for everything because no two people are alike.

When I told people about the procedure I would be having, some of them were compassionate and offered help if I needed it during recovery. Others assumed I would be on my feet and back to normal within the first week. I only knew what I was being told by my surgeon -- and to me it was a big deal.

The type of surgery itself isn't dangerous, but I was more concerned with the fact that I would only have the use of my left arm while I recovered. Not only that, I had a nerve block to help me deal with the pain. This meant that for the first week I wouldn't be able to feel my right arm and I would have no control over it.

ARLENE GRAU

I had asked several friends for help with dinner, since I was unable to cook, and to my surprise the people who were the busiest and I hadn't seen in some time came to my aid.

Still, I felt like most people thought the surgery wasn’t very invasive and I probably had very small incisions, which meant I shouldn't be in much pain. Maybe they thought I was trying to milk my situation and get sympathy, but that was never the case.

I decided to post a picture of my wrist after my first cast was removed, something I regularly do when I have procedures done, because I want people to understand what I go through and get it through their heads that I'm not making up the fact that I'm in pain all the time.

It's easy for others to say, "Don't worry about what they think" or "Turn the other cheek." But it's hard to do when you're constantly being judged. The worst part is that at times it's by the people you love the most.

To say that surgery for someone who has chronic pain is no big deal is far from the truth. My fibromyalgia is a magnet for pain and as soon as I woke up from surgery, I began to scream in agony. Yes, the nerve block numbed the pain in my arm, but the rest of my body went crazy.

I felt like I had been in a terrible accident. Any type of procedure or even a regular checkup is painful when it involves another person pressing on the areas where you feel the most amount of pain.

To assume everyone heals the same way is ignorant. Some people would rather believe that though, because it excuses them from having to show compassion towards those of us who suffer on a day-to-day basis.

Arlene Grau lives in southern California with her family. She suffers from rheumatoid arthritis, fibromyalgia, lupus, migraine, vasculitis, and Sjogren’s disease.

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.

Soaring Cost of Multiple Sclerosis Drugs 'Alarming'

By Pat Anson, Editor

The cost of drugs used to treat multiple sclerosis (MS) in the United States has soared as much as 700 percent in the past two decades, according to researchers who call the price escalation “alarming” and possibly coordinated by drug companies.

There are no multiple sclerosis drugs now available in the U.S. with a list price below $50,000 a year, which is two to three times more than the price of the same drugs in Canada, Australia or the United Kingdom. Prices of MS drugs rose at five to seven times the rate of drug inflation in the U.S.

“The coordinated price escalations for these therapies has lead to increasing access and affordability problems for patients with MS. Pricing decisions by pharmaceutical companies need to better reflect the financial realities and constraints of our healthcare system as opposed to a strategy of whatever our dysfunctional market will bear,” said Daniel Hartung, an associate professor in the Oregon State University/Oregon Health & Science University College of Pharmacy, in an email to Pain News Network.

Hartung is the lead author of a scathing new study appearing in the journal Neurology, which blames the soaring cost of MS drugs on the greed of drug companies and the inability of a national healthcare system to negotiate drug prices.

"The simplest explanation is that pharmaceutical companies raise prices of new and old MS disease modifying therapies in the United States to increase profits, and our healthcare system puts no limits on these increases," the researchers wrote in their report. "The U.S. Medicare program, the largest single-payer healthcare system in the U.S., is legally prohibited from negotiating drug prices directly with the pharmaceutical industry.

“Government-issued patent monopolies, third-party payers, lack of reimbursement transparency, and imperfect clinical information all contribute to a seemingly dysfunctional marketplace where expanded choice has led to higher, rather than lower, prices. Some argue that recent trends in industry pricing suggest collusive behavior between manufacturers, although this is challenging to prove with price data alone.”

Pricing Defies "Common Sense"

The researchers cite several examples of older MS drugs rising in price decades after they were approved by the Food and Drug Administration – and long after pharmaceutical companies recovered the cost of developing the medications.

The annual cost of Copaxone, for example, was $8,292 when it was introduced in 1996 by Teva Pharmaceuticals. Today it is $59,158 – over seven times higher.

Avonex, another early MS treatment, had an annual cost of $8,723 when it was introduced by Biogen in 1996. Today it is $62,394 – also seven times higher.

"Economics 101 would suggest that competition should lower prices. In the pharmaceutical industry we often don't see that. Many professionals now believe that it's time to push back, to say enough is enough," said Hartung.

“What has happened defies common sense, logic, and the expected rules of the marketplace,” wrote T. Jock Murray, MD, in an editorial about Hartung’s study also published in Neurology. “These counter-intuitive increases suggest the possibility of collusion among the manufacturers, but the authors say they do not have evidence.

“What justification does the pharmaceutical industry in the United States offer for the remarkable increase in the costs of these drugs? Well, they do not have to explain, as they are allowed to set prices in a black box, based on the business ethic of maximizing profit, supported by a bizarre law that prevents Medicare from negotiating prices directly with the pharmaceutical industry.”

“We cannot comment on the practices or products of other companies,” said Kate Niazi-Sai, a spokesperson for Biogen in an email to Pain News Network.

“What we can say is that since its introduction as one of the first MS therapies two decades ago, Avonex has helped many thousands of people with MS, who before then had no treatment options.  Since then revenue from Avonex has enabled the development of improved treatments so that today, patients have a breadth of options they need to deal with MS.”

Niazi-Sai said Biogen offers discount programs and free medicines to needy patients worth hundreds of millions of dollars each year. But that’s a fraction of what the company makes from MS drugs.

According to first quarter financial results released by Biogen, sales of Avonex and other MS therapies were $2.1 billion, compared to $1.7 billion in the same quarter last year.

Niazi-Sai said the money is put to good use.

“Revenue from our therapies for MS and hemophilia are now fueling the search for a way to reverse or possibly cure MS, as well as new treatments for Alzheimer’s disease, Lou Gehrig’s disease and other devastating medical conditions.  We are eager to be part of any thoughtful discussion about funding medical advances. Anyone who believes there is a better way should propose it," she wrote.

Teva Pharmaceuticals declined to comment on its pricing policies, but said in a statement to Pain News Network that “the wholesale acquisition cost for Copaxone is competitive to other branded molecules in this category. It is reflective of investments made to research, develop and commercialize a safe and effective relapsing MS product.”

MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain.

Escalating costs for MS therapies and other specialty drugs are a growing concern in the healthcare industry. A recent study said the cost of treating rheumatoid arthritis with new biologic drugs has become a “significant financial burden” for many patients. Patients enrolled in Medicare Part D plans paid an average out-of-pocket cost of $835 a month for a biologic drug in 2013. Costs varied widely depending on the drug – from $269 to $2,993 a month.

"Pricing in the pharmaceutical industry increasingly is a case of whatever the market will bear," Hartung said. "We used to think that any drug with $1 billion in sales was a blockbuster, but last year a drug for hepatitis C had 10 times that, or $10 billion in sales. This does not necessarily mean that drug research and innovation will be 10 times better.”

Chronic Pain: Nobody Tells You How Hard It Is

By Crystal Lindell, Columnist

Some days, I feel like I can finally lift my head above water. Like I can finally take a breath. Or better yet, a couple of deep breaths. 

I feel like maybe I finally have this whole chronically sick thing figured out. And, finally, after being in pain for more than two years, I can focus on living the life I want to live. Like just maybe, this whole chronic pain thing isn’t going to win after all.  

And then other days, like today, I wish I was dead.  

Days when I wake up with an insane amount of pain in my ribs, and a migraine and I have to work because I’m genuinely afraid I’ll lose my job if I call in sick one more time. 

Days when I hate my body so much, because it’s like a jail keeping me prisoner and holding me back from the life I once thought I was born to live.  And days when I want to push myself, because that’s what I do, I push things, to the limits, and that’s how I have always lived my life.

But then I do that, I push myself, and I do something crazy like go for a walk, or stay up late, or take a shower two days in a row, and then I literally end up spending the next week on the couch in too much pain to function. 

Days when all I want to want in the whole world is to lose weight, but instead, because of my stupid body, the only thing I’m allowed to want is relief from the pain. So rather than putting all my resources into losing some of the 50 pounds I’ve gained since getting sick, I have to use all my resources to just sit on the couch and check my email. 

I want so bad to worry about regular things, like whether or not my boyfriend is ever going to propose, or whether or not I’ll get that promotion. I want to think about going for a long walk, and just worry about the weather. 

But my body won’t let me. Instead, I have to worry about whether my boyfriend will, or should, stick it out with someone who is so radically different than the healthy, much thinner girl he first met almost 5 years ago. I have to worry about just keeping my job. I have to worry about whether my body has had enough time to recuperate from the walk I took three days ago to allow me to blow dry my hair. 

Being sick every day of your life is so much worse than anyone ever tells you. It’s so much harder than anyone can ever explain. 

That’s the thing, really. There’s no “talk” with the doctor when you have chronic pain. A medical professional doesn’t pull you into his office, hand you a box of tissues and say, “I’m so sorry to tell you this, but you have chronic pain.” That conversation never happens.  

Instead, they scan your test results, say something about sending you to a pain specialist and then they go on with their life, while you’re left holding the pieces. Or worse, they say, “At least you don’t have cancer.”

Everything is suddenly different, but nobody has the decency to tell you that. They just ship you off to another doctor and hand you some opioids. 

But your life has been changed forever.

There’s the constant, daily battle with the pain, and the insane side effects from the drugs you use as weapons. There’s the loneliness and the feeling of failure that comes from being stuck on the couch in pajamas all day, every day, even on Easter. There’s the assault on your faith, and the outright attack on your ability to hope. And there’s the way your brain goes crazy just trying to understand how you’ll ever endure like this forever. 

There are other days though. And on those days, for a second, you almost feel like you’ve got a handle on the situation, like you’ve got your head above water. 

Today just wasn’t one of those days. 

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.

Weird Mushroom Could Lead to New Painkillers

By Pat Anson, Editor

A creepy looking parasitic mushroom that lives on caterpillars could help British researchers develop a new class of painkillers to treat osteoarthritis and other chronic pain conditions.

Scientists at the University of Nottingham are exploring the painkilling potential of cordycepin, a compound found in cordyceps mushrooms, which have been used in traditional Chinese medicine for thousands of years.

The mushroom acts as a parasite in the larvae of ghost moths – growing inside the caterpillar until it eventually kills it. The stalk-like mushroom then grows out of the caterpillar’s mummified body.

Food pellets containing the compound were given to rats and mice to see if cordycepin could relieve pain from a joint injury. The results, according to researchers, were startling.

"When we first started investigating this compound it was frankly a bit of a long-shot and there was much skepticism from the scientific community," said Dr. Cornelia de Moor. "But we were stunned by the response from the pilot study, which showed that it was as effective as conventional painkillers in rats.

A CORDYCEPS MUSHROOM (LEFT) EMERGES FROM A DEAD CATERPILLAR

"This study is the first step in a potential drug development for a new class of drugs for osteoarthritis, although there are a number of hurdles we have to go through - necessarily so - before it gets nearer patients. To the best of our knowledge, cordycepin has never been tested as a lead compound for osteoarthritis pain."

Native Tibetan healers have used cordyceps mushrooms as a tonic to treat a wide variety of conditions. They claim it improves energy, appetite, stamina, libido, endurance, and sleeping.

Researchers believe cordycepin blocks the inflammatory process that cause pain in osteoarthritis, but does so in a way that is completely different than painkillers like corticosteroids and non-steroidal-anti-inflammatory drugs (NSAIDs) such as ibuprofen.  Still unclear is whether cordycepin acts on the knee joint or on the nerves that send pain signals from the knee to the spinal cord.

Until clinical trials can be held to test the safety and effectiveness of cordycepin – which could take years – de Moor warns against people experimenting with herbal products containing the cordyceps mushroom.

"The lack of quality control means that cordyceps preparations for sale in Europe rarely contain much cordycepin, and may contain other harmful compounds," said de Moor, who is also investigating cordycepin as a possible treatment for cancer.

"Dr de Moor's research is certainly novel, and we believe may hold promise as a future source of pain relief for people with osteoarthritis. There is currently a massive gap in available, effective, side-effect-free painkillers for the millions of people with arthritis who have to live with their pain every day, so new approaches are very much-needed,"  said Dr. Stephen Simpson, director of research at Arthritis Research UK, which is helping to fund de Moor’s research.

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

Cost of RA Drugs a 'Significant Financial Burden'

By Pat Anson, Editor

Over the last decade great strides have been made in the treatment of rheumatoid arthritis (RA), but the cost of treating the disease with new biologic drugs has become a “significant financial burden” for many patients.

According to a new study published in Arthritis & Rheumatology, RA patients enrolled in Medicare Part D plans paid an average out-of-pocket cost of $835 a month for a biologic disease modifying drug (DMARD) in 2013. Costs varied widely depending on the drug – from $269 a month for the biologic infliximab to $2,993 a month for anakinra.

Costs remained high because the vast majority of Part D plans required RA patients to pay about a third of the cost of DMARD drugs, rather than a fixed dollar co-pay amount. In addition, catastrophic coverage under Part D didn’t kick in until out-of-pocket costs reached $4,450, after which patients paid 5% of the cost of DMARD drugs.

The financial burden is too much for many patients. According to a previous study, 1 in 6 adults with RA decreased their medication because of cost.

"While specialty DMARDs have improved the lives of those with chronic diseases like RA, many patients face a growing and unacceptable financial burden for access to treatment," said lead author Jinoos Yazdany, MD, with the Division of Rheumatology at the University of California, San Francisco (UCSF).

"Rather than determining which drug is best for the patient, we find ourselves making treatment decisions based on whether patients can afford drugs.”  

Rheumatoid arthritis is a chronic and incurable autoimmune disease that causes pain and stiffness in joints. Until the late 1990s, one in three RA patients were permanently disabled within five years of disease onset. In recent years there has been significant improvement in RA treatment, with disease control now possible for many patients who receive DMARD therapy.

Treatment with DMARDs is now a standard component of care with costs for some of the newer drugs topping $20,000 annually. A recent report by GBI Research estimates that the U.S. market for RA treatment will increase from $6.4 billion in 2013 to $9.3 billion by 2020, driven in part by an increase in the number of patients with RA – which is expected to grow from 1.3 million Americans to 1.68 million by 2020.

The UCSF study analyzed Medicare Part D coverage of nine biologic medications (abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab) and nine non-biologic DMARDs (azathioprine, cuprimine, cyclophosphamide, cyclosporine, hydroxychloroquine, leflunomide, methotrexate, minocycline, and sulfasalazine).

Although nearly all Part D plans covered at least 1 biologic DMARD, access was tightly controlled, with 95% of plans requiring prior authorization.

Researchers said implementation of the Affordable Care Act (Obamacare) will not significantly lessen the cost of biologic drugs.

"Many patients are strapped with a substantial financial burden," said Yazdany. “Clinicians caring for individuals with RA should be aware of this and be prepared to discuss long-term affordability as well as relative efficacy of biologic DMARDs with their patients to help them make informed decisions about treatment. Currently, cost discussions occur in only one-third of RA office visits where changes are made to RA drug treatment.”

One alternative is the use of non-biologic DMARDs, such as methotrexate, which were once the standard treatment for RA. Both Medicare Advantage plans and PDP plans cover nearly all non-biologic DMARDs, with most charging fixed dollar co-pays that averaged $4 to $34 a month.

Researchers in Belgium recently found that a combination of older generic drugs (methotrexate, sulfasalazine and leflunomide) treated RA in its early stages just as effectively as biologics, but with less medication, fewer side effects, and at a significantly lower cost.

A similar study published in the New England Journal of Medicine found that RA patients who took three oral generic drugs (methotrexate, sulfasalazine and hydroxychloroquine) saw just as much improvement in their symptoms as those who used methotrexate and Enbrel, an injectable biologic sold by Amgen.

The average annual cost of the three drug therapy was about $1,000, compared to about $25,000 per year for Enbrel.

When Drug Tests Go Wrong

By Pat Anson, Editor

Robin Haas was driving to Disneyworld with her husband and three children in 2008 when their vehicle was rear-ended by a truck on a Florida highway. The accident left Robin with chronic back pain, and she had 17 surgeries over the next 11 months to repair her damaged spine.

It was only the beginning of her problems.

Last year Robin was kicked out of a pain management practice after two office urine tests failed to find any trace of the fentanyl patch she was wearing for pain relief – a red flag for physicians that a patient may be diverting a drug.

Initially, Robin says her doctor didn’t seem too concerned.

“When it happened the second time, he said ‘Don’t worry about it. It’s happened with several of my patients with the fentanyl patches,’” Robin said

About a week later, she was shocked to get a certified letter from the doctor discharging her.

“I don’t know what happened. I really don’t,” Robin told Pain News Network. “I was just mortified. I never did anything wrong in pain management. Ever.”

What happened to Robin is not uncommon. According to a recent study, immunoassay urine tests widely used by pain management doctors to screen patients for drug use are wrong about half the time – frequently giving false positive or false negative results.

“Clearly, people don’t know how to interpret these tests,” said Jeffrey Fudin, a pharmacist and patient advocate, who says most physicians have no idea how inaccurate immunoassay testing is.

“I’m positive that they don’t. I get probably 50 emails a week from all over the country from concerned physicians and nurse practitioners who want to make the right decision, but they’re not sure what to do,” said Fudin.

"The other problem is there are no standards. You can go to five different providers and be treated five different ways for the same results.”

Fudin says fentanyl may not show up on an opiate screen because it has a  different chemical structure compared to most commonly prescribed opioids. There can also be false negatives because an opioid is simply prescribed in too low of a dose to be detected.

Some medications can also trigger false positives for an illicit drug. Widely used pain relievers like naproxen and ibuprofen, for example, can trigger a false positive for marijuana. 

To help doctors correctly interpret immunoassay results, Fudin is developing an online app called Urintel that can help them decide whether to take a negative or positive drug screen seriously – and whether to order more reliable and more expensive confirmation testing in a laboratory.

“Basically, it’s educational and it’s not punitive to the patient,” said Fudin about his app.

“My goal is to make opioid therapy as safe as possible and to make it individualized for each patient. And also to be fair, not only to patients, but providers because it’s not their fault that they don’t have training in pharmacokinetics or biochemistry. It takes a lot of things to understand the complexity of this.”

Fudin’s app may be too late to help pain patients like Robin Haas. She just hopes more patients aren’t wrongly accused of diverting or abusing drugs because of a test that is so often wrong.

“I guarantee not one of my pills has ever hit the street,” says Robin.

The 43-year old Florida resident says the pain clinic told her that her urine samples were re-tested in a laboratory – at a cost of $18,000 – but the results came back the same. She’s still not sure what went wrong. The  clinic has refused to identify the laboratory it used or provide her with the lab results. She had to find a new doctor.

“It’s a horrible thing to happen to people. And when you’re having to deal with chronic pain to begin with, nobody should have to go through it,” she says.

Have you been wrongly accused of failing a drug test?

Tell us your story. Send an email to editor@PainNewsNetwork.org.

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Opioid Dispensing and Overdoses Down Sharply

By Pat Anson, Editor

Dispensing of opioid pain relievers and painkiller overdoses both declined substantially after an abuse-deterrent formula of OxyContin was introduced and the painkiller propoxyphene was withdrawn from the U.S. market in 2010, according to a new study published online in JAMA Internal Medicine.

The study is another 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. Last week another study was released showing that the painkiller hydrocodone was no longer the most-widely prescribed drug in the U.S. 

Researchers analyzed claims from over 31 million members of a large national health insurer, and estimated that by 2012 total opioid dispensing declined by 19% and the overdose rate dropped by 20 percent. The drop in prescription opioid overdoses was partially offset by a 23% increase in overdoses due to heroin.

“Our results have significant implications for policymakers and health care professions grappling with the epidemic of opioid abuse and overdose,” said lead author Marc Larochelle, MD, of the Harvard Medical School and Boston University School of Medicine.

"Changes imposed through regulatory mandates or voluntary company actions may be a viable approach to stemming prescription abuse. However, identifying interventions that reduce opioid supply without affecting access to individuals who benefit from opioid therapy remains a challenge.”

Propoxyphene (also known as Darvon) was voluntarily withdrawn from the U.S. market after data emerged about its cardiac toxic effects.

The abuse-deterrent formula of OxyContin introduced by Purdue Pharma in 2010 is harder for drug abusers to crush or dissolve for snorting or injecting. Researchers said the prescribing of OxyContin and other extended released oxycodone products dropped by 39% in the two years after the formulation change.

They noted there was “minimal” evidence that people switched to other pain medications because of the formulation change – an indication they weren’t taking OxyContin for pain relief.

"These results suggest that many people who were prescribed OxyContin before it was reformulated may have been diverting or misusing the drug," said Larochelle. "Given the decreased supply of prescription opioids, those seeking out an opioid could be turning to heroin, which may partially explain the tremendous increase in heroin overdose deaths over the past few years both locally and nationally."

“This study parallels other independent and internal research that shows reformulated OxyContin is associated with a reduction in abuse,” Purdue Pharma said in a statement.

“We agree with the FDA, the U.S. Drug Enforcement Administration, The White House Office of National Drug Control Policy and many federal and state policymakers that abuse-deterrent formulations are a valuable public health tool that must be part of any comprehensive approach to combatting prescription drug abuse.”

The study also suggests that legitimate pain patients were not the ones abusing opioids.

“Most overdoses do not occur among patients who are receiving daily prescribed opioids or among those receiving the highest doses,” said Hillary Kunins, MD, of the New York City Department of Health and Mental Hygiene in an editorial also published in JAMA Internal Medicine.

"Recasting the often-maligned 'doctor-shopper' instead as a patient with a substance use disorder reminds us that using public health strategies to promote judicious opioid prescribing, including via pharmaceutical market change to reduce overdose risk, needs to be accompanied by similar policy approaches to provide accessible and effective services for people who use drugs.”