NSAIDs Raise Risk of Heart Attack Within Days

By Pat Anson, Editor

Taking prescription strength non-steroidal anti-inflammatory drugs (NSAIDs) raises the risk of a heart attack as soon as the first week of use, according to a large new study published in The BMJ.

An international teams of researchers analyzed data from eight studies involving nearly 450,000 patients in Canada, Finland and Germany -- 61,460 of whom had a heart attack. They found that taking any dose of NSAIDs for one week, one month, or more than a month was associated with an increased risk of myocardial infarction. Researchers estimated that the overall risk of a heart attack was about 20 to 50% higher when using NSAIDs.

"Given that the onset of risk of acute myocardial infarction occurred in the first week and appeared greatest in the first month of treatment with higher doses, prescribers should consider weighing the risks and benefits of NSAIDs before instituting treatment, particularly for higher doses," wrote lead author Michèle Bally, PhD, an epidemiologist at the University of Montreal Hospital Research Center.

The NSAIDs of particular interest to the researchers were ibuprofen, diclofenac and naproxen, as well as the COX-2 inhibitors celecoxib and rofecoxib. COX-2 inhibitors work differently than traditional NSAIDs, by targeting an enzyme responsible for pain and inflammation.

“All NSAIDs, including naproxen, were found to be associated with an increased risk of acute myocardial infarction. Risk of myocardial infarction with celecoxib was comparable to that of traditional NSAIDS and was lower than for rofecoxib. Risk was greatest during the first month of NSAID use and with higher doses,” Bally wrote.

Several previous studies have also found that NSAIDs and COX- 2 inhibitors raise the risk of a heart attack, but the exact cause is unknown. Researchers at the University of California Davis reported last year that NSAIDs impaired the activity of cardiac cells in rodents.  

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

In 2015, the U.S. Food and Drug Administration ordered that stronger warning labels be put on NSAIDs to indicate they increase the risk of a heart attack or stroke. The warning does not apply to aspirin.

“There is no period of use shown to be without risk,” said Judy Racoosin, MD, deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products. “Everyone may be at risk – even people without an underlying risk for cardiovascular disease.”

The BMJ study was published the day after Canada released new guidelines that recommend NSAIDs as an alternative to opioid pain medication. The Canadian guideline makes no mention of the health risks associated with NSAIDs, but focuses on their “cost effectiveness.”

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

Opioid guidelines released last year by the U.S. Centers for Disease Control and Prevention, which the Canadian guideline was modeled after, also recommend NSAIDs as an alternative to opioids, but acknowledge the medications “do have risks, including gastrointestinal bleeding or perforation as well as renal and cardiovascular risks.”

Despite those risks, the CDC cited the low cost of NSAIDs and other non-opioid treatments as an “important consideration” for doctors.

“Many pain treatments, including acetaminophen, NSAIDs, tricyclic antidepressants, and massage therapy, are associated with lower mean and median annual costs compared with opioid therapy,” the CDC guideline states.

Don’t Drown in Anxiety Over Healthcare Bill

By Barby Ingle, Columnist  

With everything going on with the American Health Care Act (AHCA), there is a lot of anxiety and stress over possible changes to our health coverage.

There were people who took to social media to start their protests before all of the facts were in. I have yet to read the actual bill and when I reached out to others who were commenting on it -- as if they read it and knew what was in it – well, they have not read it yet either.

So I kept looking and found an interview with House Speaker Paul Ryan, which talked about the biggest concern most of us have – pre-existing conditions. Before the Affordable Care Act (Obamacare) became law, people with pre-existing conditions paid several times more than others — if they could afford or be approved for a policy in the first place.

The latest version of the ACHA passed by the House would allow states to seek waivers from existing federal law and create “high risk pools” that would allow insurers to charge more for pre-existing conditions if someone lets their insurance lapse.

To help combat the increased premiums and out-of-pocket costs, GOP Reps. Fred Upton (MI) and Billy Long (MO) crafted a provision to provide $8 billion to states to help fund high risk pools or subsidy programs for people with pre-existing conditions. It would be left to each individual state to decide how to spend the money.

If you have a pre-existing condition, what can you do? First, contact your state legislators and make sure that your health conditions are covered under any pool or subsidy program. It is up to us to raise our voices, share our stories, and demand that our lawmakers remember us and our conditions as they move forward.

Luckily for us, there are many steps to go in this process and we don’t know what the outcome will be. The U.S. Senate still has to vote on the ACHA and is likely to make changes.  It is also important to note that the House version of the ACHA does not spell out what sort of pre-existing conditions insurers may cover if states seek a waiver. In the past, some insurers identified domestic violence, sexual assault, caesarean birth and postpartum depression as grounds for denying coverage or charging higher premiums.

Letting ourselves drown in hearsay, low expectations of the current administration, and sharing information that is not accurate to make a point is not going to fix or change anything. It will only cause us anxiety, stress and energy pennies that as chronically ill patients we don’t have the ability to recover from.

Is it time to act? YES. Is it time to over-react? NO. The water is rising, but it’s only up to our knees and we’re still standing. Before the tide comes in further, make sure you are doing what you can to be heard and in ways that will matter for our pain communities. VOTE, make phone calls, be willing to testify in person if needed, answer calls from the media to discuss how the ACHA will affect you if the conditions you are living with are not covered.

Don’t exaggerate or give false information about a list of pre-existing conditions that won’t be covered. Remember, each state will decide what pre-existing conditions will be included if they get the waiver granted. Instead, bring to light that our healthcare costs are already higher than healthy patients, because we have more doctor visits and treatments, and are paying more in out of pocket costs.

Our options are already limited and we need to have a seat at the table of decision makers. We can get that by being factual and accurate, and by voting for people who will remember our stories.  

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. 

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.

Does Coffee Work Better Than Painkillers?

By Pat Anson, Editor

Insomnia and chronic sleep loss are well known to increase pain sensitivity. But an unusual animal study suggests that stimulants that keep you awake – like a cup of coffee -- may give sleep deprived patients more pain relief than morphine or ibuprofen.

That unexpected finding was reached by researchers at Boston Children's Hospital and Beth Israel Deaconess Medical Center, who studied pain sensitivity in sleep deprived laboratory mice.

Unlike other sleep studies that force rodents to stay awake walking treadmills or falling off platforms, the researchers deprived the mice of sleep in a way that mimics what happens with people: They entertained them.

"We developed a protocol to chronically sleep-deprive mice in a non-stressful manner, by providing them with toys and activities at the time they were supposed to go to sleep, thereby extending the wake period," says sleep physiologist Chloe Alexandre, PhD.

“This is similar to what most of us do when we stay awake a little bit too much watching late-night TV each weekday."

The mice wore “tiny headsets” to monitor their sleep cycles and sensitivity. Whenever they showed signs of sleepiness, the mice were given toys to keep them alert.

"Mice love nesting, so when they started to get sleepy, we would give them nesting materials like a wipe or cotton ball," says pain physiologist Alban Latremoliere, PhD. "Rodents also like chewing, so we introduced a lot of activities based around chewing, for example, having to chew through something to get to a cotton ball."

The mice were kept awake for as long as 12 hours in one session, or six hours for five consecutive days. Pain sensitivity was measured by exposing the mice to controlled amounts of heat, cold, pressure or capsaicin -- the chemical agent in chili peppers -- and then seeing how long it took the animal to move from or lick away the discomfort.

"We found that five consecutive days of moderate sleep deprivation can significantly exacerbate pain sensitivity over time in otherwise healthy mice," says Alexandre.

Surprisingly, when the mice were given ibuprofen or morphine, the analgesics didn’t seem to reduce their pain sensitivity. But when the rodents were given caffeine or modafinil, a drug used to promote wakefulness, it blocked the pain caused by sleep loss. Researchers think the caffeine and modafinil gave the mice a jolt of dopamine – a “feel good” hormone – that helped alleviate their pain.

"This represents a new kind of analgesic that hadn't been considered before, one that depends on the biological state of the animal," Clifford Woolf, a professor of neurology and co-senior author of the study. "Such drugs could help disrupt the chronic pain cycle, in which pain disrupts sleep, which then promotes pain, which further disrupts sleep."

The study only involved rodents, but researchers were quick to suggest there are lessons to be learned for people. Rather than just taking painkillers, they say pain patients would benefit from better sleep habits or by taking sleep-promoting medications at night.

"Many patients with chronic pain suffer from poor sleep and daytime fatigue, and some pain medications themselves can contribute to these co-morbidities," notes Kiran Maski, MD, a specialist in sleep disorders at Boston Children's. "This study suggests a novel approach to pain management that would be relatively easy to implement in clinical care.”

Canadian Opioid Guideline Modeled After CDC’s

By Pat Anson, Editor

Canada this week is officially adopting new guidelines for the prescribing of opioid pain medication that are very similar to those released by the U.S. Centers for Disease Control and Prevention a little over a year ago.

And, like the CDC guidelines, there is controversy over the role played by addiction treatment specialists and anti-opioid activists in drafting them.

The Canadian guideline, developed at the National Pain Centre at McMaster University and published in the Canadian Medical Association Journal, contains 10 recommendations for treating non-cancer chronic pain, most of them focused on reducing the use of opioid medication.

"Opioids are not first-line treatment for chronic non-cancer pain, and should only be considered after non-opioid therapy has been optimized," said Jason Busse, PhD, lead investigator for the guideline and an associate professor of anesthesia at McMaster University’s School of Medicine.  "There are important risks associated with opioids, such as unintentional overdose, and these risks increase with higher doses."

Nearly 1 in 5 Canadians suffer from chronic pain and Canada has the second highest rate of opioid prescribing in the world. Opioid overdoses are soaring in Canada, as they are in the United States, but increasingly the deaths involve illegal opioids such as heroin and illicit fentanyl, not prescription painkillers.

The new guideline recommends that non-drug therapies, such as exercise and cognitive behavioral therapy, and non-opioid medications such as non-steroidal anti-inflammatory drugs (NSAIDs), be used first in treating patients with chronic pain. It is recommended that opioids only be prescribed if patients do not respond to non-opioid treatments, and only if they do not have a history of substance abuse or a psychiatric disorder.

The guidelines also suggest that initial doses of opioids be limited to no more than 50 mg morphine equivalents daily (MED), and strongly recommend that doses not exceed 90 mg MED. The previous Canadian guideline suggested a ceiling of 200 mg MED. For patients who already exceed 90 mg MED, the guideline recommends the gradual tapering of opioids to the lowest effective dose or to discontinue opioid treatment altogether.

"The opioid epidemic has serious consequences for families and communities across Canada. We are committed to working with our partners to ensure a comprehensive response to this public health crisis, including supporting physicians in improving prescribing practices. I applaud the work that went into updating the prescription opioid guideline, and I urge healthcare professionals to apply the recommendations when prescribing these types of medications," said Jane Philpott, Canada's Minister of Health, in a statement.

A major difference with the CDC guideline, which is intended only for primary care physicians, is that the Canadian version applies to all prescribers, including family physicians, pain specialists and nurse practitioners.

The Canadian guideline was also developed with more transparency than the CDC guideline, which was initially drafted in secret meetings by an unidentified panel of experts.  Leaks later revealed that the panel included several academics and addiction treatment specialists, but only one retired doctor with experience in pain management.

PROP Involved in Canadian Guideline

Four advisory panels involving over 50 clinicians, academics, patients and “safety advocates” helped draft the Canadian guideline. Among them were three board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played a key role in drafting the CDC guidelines: PROP Vice-President Gary Franklin, MD, Mark Sullivan, MD, and David Juurlink, MD.

Juurlink, an academic toxicologist at Sunnybrook Health Sciences Centre in Toronto, had an influential role on the Canadian Guideline Steering Committee; while Franklin and Sullivan, both of them Americans affiliated with the University of Washington, served on the Clinical Expert Committee.

Juurlink and Sullivan disclosed their involvement with PROP in their conflict of interest statements, while Franklin did not specifically name the group.

“These guidelines, which appear to be influenced by the extremely flawed and biased guidelines by the CDC in the United States, written by a small group of anti-opiate crusaders with strong ties to a large drug rehab chain, seem to reflect more attention to people with addictions and not people with pain,” said Barry Ulmer, Executive Director of the Chronic Pain Association of Canada, in written comments to the guideline.

PROP's founder and Executive Director, Andrew Kolodny, MD, was until recently chief medical officer of Phoenix House, which runs a chain of addiction treatment facilities in the U.S.

A news release on the guideline produced by McMaster University emphasizes that experts with “diverse views on the role of opioids” participated in drafting them and only those “without important financial or intellectual conflicts of interest” were allowed to vote on the recommendations.

Ulmer says the guidelines should have focused on improving pain education for physicians, which is limited in medical schools in both Canada and the U.S.

“Pain patients feel strongly the authors and policy makers behind these guidelines have missed another golden opportunity to create real change in this area of medicine. They would have impacted pain medicine far more positively if they had used their resources to develop forward thinking educational programs and incorporate them into the curricula in our teaching hospitals,” Ulmer wrote.

“By putting forth guidelines like this, at this time, to influence (or control) a profession that has little education and understanding about chronic pain is myopic and similar to the last attempt at guidelines will simply encourage more physicians to dump pain patients they now have. Or is that the real goal?”

One of the many unintendend consequences of the CDC guidelines in the United States is that pain patients are losing access to treatment. A recent survey of over 3,100 patients by PNN and the International Pain Foundation found that over 60 percent had a hard time or were unable to find a doctor willing to treat their chronic pain. Over 90 percent believe the CDC guidelines have harmed patients and worsened the quality of pain care. 

Although the CDC guidelines are voluntary and only intended for primary care physicians, they are being implemented and treated as mandatory by many prescribers, insurers, and federal and state agencies. Critics worry the same thing could happen in Canada.

“No guideline can account for the unique features of patients and their clinical circumstances, and the new guideline is not meant to replace clinical judgment. Patients, prescribers and other stakeholders, including regulators and insurers, should not view its recommendations as absolute,” wrote Drs. Andrea Furlan of the Toronto Rehabilitation Institute, and Owen Williamson of Monash University in Australia, in an editorial published in the Canadian Medical Association Journal.

British Columbia adopted its own mandatory version of the CDC guidelines nearly a year ago, and made them a legally enforceable standard of care for all prescribers. The move has yet to slow the rising tide of drug overdoses in British Columbia, which are now occurring at a rate of four deaths every day. Most of the overdoses are blamed on illicit fentanyl and other street drugs, not prescription opioids.

A Pained Life: Lost in Translation

By Carol Levy, Columnist

Whenever I go to a doctor with a pain related complaint, I am asked the question we all know: “On a scale of 1 to 10, how bad is it?”

I always preface my answer: “Only trigeminal neuralgia is a 10.”

Nevertheless, they persist: “Give me a number. Well, okay, if I have to, I guess a 6.”

What does that mean? To me, it means the pain is pretty bad. Compared to trigeminal neuralgia, nothing can ever reach a 10 (I pray). As such, a 6 is pretty bad.

But to them, a 6 is not all that bad. I get the equivalent of a pat on the head and “take some aspirin or Advil.” Luckily, I am pretty healthy and usually that works. The few times it hasn't, it took a number of appointments, in one case a number of years, before I got a diagnosis and referral to someone who could help me.

On a scale of 1 to 10, who decides what’s qualifies as a 1 or what is a 10?

Each doctor, nurse and practitioner has their own definition in mind. I have yet to hear one say, “Well, I consider stubbing your toe a 2, appendicitis a 6, breaking your leg a 9. Based on that rating, what is your pain level?”

Then at least we'd have some basis for comparison and would be speaking the same language.

Years ago I walked into a neurologist's exam room. The air conditioning was on. It was triggering my trigeminal neuralgia. “Could you turn that down? It is really setting off my pain,” I asked.

The doctor looked at me and practically snarled, “If it was really making your pain bad you would have turned it off yourself.”

No, I wouldn't. I was not raised that way. As a female, as a patient, and as a person who tries to be courteous. It was his office and his air conditioner. It was not my place to just walk over and change the settings.

What we have here is a failure to communicate. He did not ask me, “If it is causing so much pain, why didn't you just turn it off yourself?”

I did not reply to what felt like an attack on me and my truthfulness. And he wrote in his records, “I do not think her pain is as bad as she says.”

We often talk and write about issues of communication.

“Friends, coworkers, and family don't understand my pain.”

“The doctor won't give me the medication I need.”

“He ignores my complaints.”

Maybe the issue is not being ignored or misunderstood. Maybe it is simpler than that.

When I was in high school, we had a Brazilian foreign exchange student live with us. She spoke no English. I spoke no Portuguese. The two of us walked around with a Portuguese-English dictionary. I looked up the English words and spoke the Portuguese equivalent. She looked up the Portuguese words so she could speak to me in English. It was tedious, but it worked.

Before we can go forward with getting help and understanding, maybe we need to do the same. Find a dictionary so we are all on the same page.

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.

Hydrocodone Prescriptions Continue Falling

By Pat Anson, Editor

For the fifth year in a row, fewer prescriptions for the opioid painkiller hydrocodone were dispensed in the U.S. in 2016, according to a new report by the QuintilesIMS Institute, which tracks prescription drug use and spending.

The report adds further evidence that the nation’s overdose epidemic is being fueled by illegal opioids such as heroin and illicit fentanyl, not prescription painkillers.

About 7 million fewer prescriptions were filled last year for hydrocodone, which is usually combined with acetaminophen in Vicodin, Lortab, Lorcet, Norco, and other hydrocodone combination products.

As recently as 2012, hydrocodone was the #1 most widely dispensed medication in the nation, with 136 million prescriptions filled. Since then, hydrocodone prescriptions have fallen by over a third, to 90 million prescriptions.

Hydrocodone now ranks fourth, behind the thyroid drug levothyroxine (Synthroid), the blood pressure medication lisinopril (Zestril), and the statin atorvastatin (Lipitor).

Hydrocodone was reclassified by the DEA as a Schedule II controlled substance in 2014, making it harder to obtain. Opioid guidelines released last year by the CDC also probably had an impact, although hydrocodone prescriptions were falling long before the CDC and DEA acted.

HYDROCODONE PRESCRIPTIONS IN U.S. (MILLIONS)

Source: QuintilesIMS Institute

Prescriptions for hydrocodone and other opioids are likely to fall even further in 2017, because the DEA plans to reduce the supply of almost every Schedule II opioid pain medication by 25 percent or more "to prevent diversion." The 2017 quota for hydrocodone is being reduced by a third, to 58.4 million prescriptions, which the DEA considers an adequate supply.

Overall, QuintilesIMS reported 13 million fewer prescriptions for pain medicines in 2016, “as restrictions on prescribing and dispensing become increasingly common and impactful.” The company includes both narcotic and non-narcotic treatments in its pain medicine category.

Over 7 million more prescriptions were written last year for gabapentin (Neurontin), a medication originally developed to treat seizures that is now widely prescribed for neuropathy and other chronic pain conditions.  About 64 million prescriptions were written for gabapentin in 2016, a 49% increase since 2011.

More prescriptions are also being written for ibuprofen, a widely used pain reliever available both by prescription and in over-the-counter drugs. About 44 million prescriptions were filled for ibuprofen in 2016, a 19% increase since 2012.

The shift in prescribing away from opioids is hardly a surprise to pain sufferers. According to a recent survey of over 3,100 patients by PNN and the International Pain Foundation, over 70% said they were no longer prescribed opioids or were getting a lower dose since the CDC guidelines were released. About half of the doctors and pharmacists we surveyed also said they were writing or filling fewer opioid prescriptions, or had stopped them altogether.  

“My doctor cut me off hydrocodone cold turkey last fall leading to an overnight in the hospital emergency room,” a patient with chronic back pain and anxiety told PNN. “For years I have been stable on a mix of hydrocodone and Valium. Last October my doctor said he would only fill one prescription and asked me to make a choice so I stayed with the Valium.”

“With the VA allowing me only 2 hydrocodone per day now, I get very little exercise and stay in bed a lot,” a 70-year old veteran wrote. “My quality of life has gone down considerably. Before the changes, I stayed quite active taking 4 hydrocodone a day.”

“I had an interventional pain management doctor scream at me that the guidelines were mandatory and he refused to write for any type of opioids even though I've been on the same level of hydrocodone for several years,” another patient said.

“I took hydrocodone pain medicine for 25 years as the doctor proscribed. Never called in for more, now I'm having to go a pain doctor and get steroid shots every 3 months,” wrote a patient with lives with chronic back pain.

Overall spending on prescription drugs in the U.S. reached $323 billion in 2016, a 4.8% increase that is less than half the rate of the previous two years. The QuintilesIMS report blames the slowdown in growth on increased competition among drug makers and efforts to limit price increases.

“New medicines introduced in the past two years continue to drive at least half of the total growth as clusters of innovative treatments for cancer, autoimmune diseases, HIV, multiple sclerosis, and diabetes become accessible to patients,” said Murray Aitken, Senior Vice President and Executive Director, QuintilesIMS Institute.

Study Finds ‘Nocebo Effect’ of Statins Cause Pain

By Pat Anson, Editor

An industry funded study is adding more fuel to a sometimes heated debate over statins – and whether the cholesterol-lowering drugs cause muscle pain and weakness.

Research involving nearly 10,000 patients published in The Lancet medical journal suggests that people taking Lipitor – the brand name for the statin atorvastatin -- are more likely to report muscle aches and other side effects, but only if they knew there were taking the drug.

This is what is called the “nocebo effect” – the opposite of the placebo effect – where people complain of side effects because they expect to have them.

"Just as the placebo effect can be very strong, so too can the nocebo effect. This is not a case of people making up symptoms, or that the symptoms are 'all in their heads'. Patients can experience very real pain as a result of the nocebo effect and the expectation that drugs will cause harm,” said lead author Peter Sever of the National Heart and Lung Institute at Imperial College London.

“What our study shows is that it's precisely the expectation of harm that is likely causing the increase in muscle pain and weakness, rather than the drugs themselves causing them."

Sever said complaints about the side effects overstate how common the problems are and discourage people from taking statins, resulting in "thousands of fatal and disabling heart attacks and strokes, which would otherwise have been avoided."

“These results will help assure both physicians and patients that most AEs (adverse effects) associated with statins are not causally related to use of the drug and should help counter the adverse effect on public health of exaggerated claims about statin-related side-effects,” he said.

The study was funded by Servier Research Group, Leo Laboratories and Pfizer – the maker of Lipitor. Five of the eight co-authors reported potential conflicts of interest, including payments from Pfizer and other drug makers that manufacture statins.  

Only about 2 percent of the patients taking Lipitor in The Lancet study reported having muscle pain, a finding that is substantially at odds with previous research.

For example, in a study at the Cleveland Clinic last year, 42 percent of patients taking Lipitor reported muscle pain and weakness. Other studies have found muscle pain in 5% to 29% of statin users.

The Food and Drug Administration considered the problem serious enough that in 2014 it required warning labels on statins, cautioning that some statins can cause a muscle injury called myopathy, which is characterized by muscle pain or weakness. In rare instances, the FDA says statins can also cause liver injury, diabetes and memory loss.

Another study this week, published in JAMA Internal Medicine, linked statin use to back pain conditions such as spondylosis and intervertebral disc disorders. The study involved over 13,000 military veterans and their families.

“To our knowledge, this study is the first to report greater odds of back disorders among statin users compared with the odds of nonusers in a population with equal access to and the same cost of health care,” said Una Makris, MD,  of the VA North Texas Health Care System in Dallas. “Our results provide additional motivation to further investigate the overall influence of statin therapy on musculoskeletal health, specifically if prescribed for primary prevention in physically active individuals.”

Study Finds Alcohol Risky but Effective Pain Reliever

By Pat Anson, Editor

The dangers of alcohol are well known – from drunk driving to health, work and social problems. But with opioid painkillers becoming harder to obtain, some chronic pain sufferers are turning to alcohol to dull their pain.

And now there’s research to back them up.

In an analysis of 18 studies published in the Journal of Pain, British researchers found “robust evidence” that a few drinks can be an effective pain reliever.

“Findings suggest that alcohol is an effective analgesic that delivers clinically-relevant reductions in ratings of pain intensity, which could explain alcohol misuse in those with persistent pain despite its potential consequences for long-term health,” wrote lead author Trevor Thompson, PhD, University of Greenwich.

Thompson and his colleagues say a blood-alcohol content of .08% -- which meets the legal definition of drunk driving in many U.S. states – produces a “moderate to large reduction in pain intensity” and a small elevation in pain threshold.

“It can be compared to opioid drugs such as codeine and the effect is more powerful than paracetamol (acetaminophen),” Thompson told The Sun newspaper.  “If we can make a drug without the harmful side effects then we could have something that is potentially better than what is out there at the moment.”

Despite the risks involved, some pain sufferers are turning to alcohol as a last resort and mixing it with pain relievers – a potentially lethal combination.

“My doctor took me off all opioids last year and put me on Effexor, Naproxen, and extended relief Tylenol. It barely touches my pain so I am also drinking each night to help dull the pain,” one patient told us.

“The doctor tried gabapentin but I ended up with an overnight stay in the hospital due to a bad reaction to the medication,” another patient said. “I'm now using alcohol nightly to help me sleep along with high amounts of Naproxen and Tylenol daily.”

“I suffer extreme back and neck pain. Since they no longer prescribed painkillers I started drinking and find it is helpful. I take also thousand mg of arthritis Tylenol every day,” wrote another patient.  “It's either suicide or drinking. Frankly I'd prefer death. Too bad they can't give painkillers anymore.”

How much is too much?

According to the Mayo Clinic, moderate alcohol consumption for healthy adults means up to one drink a day for women of all ages and men older than age 65, and up to two drinks a day for men age 65 and younger.

What You Need to Know About Chronic Pain

By Sarah Elizabeth Hirschle, Guest Columnist

This is a side of my life not many know about, except close friends and family.

This is me when traveling anywhere over an hour away. I can only sit in the car for up to an hour. I was traveling to my doctor's appointment several hours away. 

I share for awareness, not pity.

In the past three weeks, I have been able to leave the house twice a week at most. Some of those days were just short car rides to get some fresh air and sun. 

This is the sad reality of so many chronic pain patients. Much more awareness is needed, especially in the medical community. 

If you have a loved one that is suffering from pain, please listen. Talk to them, let them know you care. Even if you don't know what to do to help or hate seeing them that way. 

A few things to know about chronic illness and pain:

SARAH ELIZABETH HIRSCHLE

• The pain causes depression and depression causes pain.

• Pain is very isolating, making patients feel unlovable and alone, when in fact we need love and companionship the most at these times.

• True chronic pain patients who are on narcotics for pain do not get high from their meds.

When your body is under stress and in insurmountable amounts of pain, all you get from opioid medication is relief. There is a big difference between dependence and addiction.

We do what whatever is necessary to have some quality of life.

Please reach out if you know someone is suffering. You may save their life without knowing it.

Sarah Elizabeth Hirschle lives in Pennsylvania. Sarah contracted Lyme disease as an infant, which caused permanent organ damage. At age 20, her spinal cord was damaged during a botched epidural and she developed arachnoiditis.  Sarah also lives with Chronic Regional Pain Syndrome in her legs and feet.

Sarah helps run a Facebook support group called Arachnoiditis Everyday and moderates the Facebook page of the Arachnoiditis Society.

Pain News Network invites other readers to share their stories with us.  Send them 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.

Pain Poem: A Misery Too Great to Bear

"A Misery Too Great to Bear"

By Angelika Byczkowski

People in pain are dying,
a reluctant calculation,  
the only option left to escape
a misery too great to bear.

While we struggle with our pain,  
our government has decided   
to snatch relief from opioids  
away from us for our own good.  

They say one pill begins the end,  
addiction guaranteed.
We say we need a powerful shield
only opioids can provide.  

By policy now unarmed, defenseless,
we are stalked by pain through every moment.  
It hunts us down relentlessly,  
sinks fangs in deep and feasts.

It rips the flesh and breaks the bones,   
cracks the skull and snaps the spine,  
with license to do just as it pleases,  
impunity guaranteed by decree.  

We are sent out naked now  
to battle this rampaging pain  
with methods long disproven, yet  
"believe and it will be" they say.

Denied our armor, medication  
callously denied by guidelines,   
we teeter at the ragged gash  
where soul was ripped from body.  

How much pain and for how long  
can we be asked to bear,  
while experts coin their catchy phrases,  
call our pain "catastrophizing".

A catastrophe indeed is pain:
It traps us in the wreckage,  
wandering the sad remains    
of tortured flesh that cannot heal.

What we know is pain, we feel  
only pain, exploding pain,  
pain so bad it breaks our will
to live like this forever.  

Pain dominates, annihilates,
ruthless in its roaring rage, while  
helpless at the feet of the beast,
we lie sacrificed for overdoses not ours.

People in pain are dying,
a reluctant calculation,  
the only option left to escape
a misery too great to bear.

Angelika Byczkowski suffers from Ehlers-Danlos Syndrome and fibromyalgia. Until she was disabled by progressive pain and fatigue, Angelika was a high tech IT maven at Apple and Yahoo. She lives in California’s Santa Cruz Mountains with her husband and various four-legged kids.

When pain isn't keeping her flat on her back, she spends her limited energy researching and blogging about chronic pain, EDS, and fibromyalgia at EDS Info.

Pain News Network invites other readers to share their stories (and poems). Send them 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.

Better Analysis Needed on Non-Medical Use of Opioids

By Willem Scholten, PharmD MPA, Guest Columnist

A few months ago, the medical journal World Psychiatry published an article that focused on the global non-medical use of prescription drugs, particularly psychoactive substances such as opioids.

Unfortunately, the two authors -- Dr. Silvia Martins and Dr. Lilian Ghandour -- ignored the distinction between prescription and prescribed opioids, adding unnecessary confusion to the already complex debate about access to pain treatment. Further, Dr. Martins said in the Washington Post that the non-medical use of psychoactive substances could turn into a pandemic if we are not careful.

Both authors are affiliated with Columbia University’s Mailman Institute of Public Health, which claims to work in the interest of underserved people in developing countries. Access to effective pain treatment in developing countries is already now more difficult than in the U.S.

Elsewhere, I have demonstrated that access to prescribed opioids for adequate pain treatment is a problem for 5.5 billion people living in countries where opioid analgesics are not available or inaccessible for patients in need.

In most countries, the per capita consumption of legitimately prescribed opioid analgesics (as officially reported to the International Narcotics Control Board) remains much lower than in the U.S. and Canada, in extreme cases even up to 50,000 times lower.

Distinction Between “Prescribed” and “Prescription” is Key

There is a vast difference between prescription and prescribed opioids. Prescription opioids are intended to be prescribed as medicines. Prescribed medicines are actually prescribed by a physician and dispensed by a pharmacy.

About 75% of fatal overdoses from prescription opioids in the U.S. occur in people who have not been prescribed opioids during the three months preceding their deaths. Thus, the majority must have obtained these prescription opioids on the black or gray market.

Without referencing the data, Drs. Martins and Ghandour claim that prescription opioids are causing serious problems in other parts of the world. However, data from the European Monitoring Centre for Drug and Drug Addiction and the European Drug Report indicate that diversion of prescription opioids is not a serious problem in Europe. In other regions of the world, per capita prescription of opioids is very low.

Drs. Martins and Ghandour claim a high prevalence of non-medical use of prescription opioids in Saudi Arabia. However, those medicines are hardly ever prescribed in that country and medical consumption rates are only about 2.5 % of the U.S. volume. Therefore, Saudi Arabia’s non-medical use of prescription opioids can hardly originate from prescribed opioids.

Unfortunately, World Psychiatry refused to publish a letter I wrote with other experts which addressed the misunderstandings stemming from Drs. Martins and Ghandour’s article.

PROP and the Anti-Opioid Lobby

The anti-opioid lobby in the U.S. does not shy away from using arguments not based on facts, just like Drs. Martins and Ghandour in their article. For example, Physicians for Responsible Opioid Prescribing (PROP) perpetuates the mistaken conflation of prescription and prescribed opioids, advocating in the U.S. against the legitimate medical prescribing of opioid analgesics. PROP tries to justify its position using false statistics, as I demonstrated in a recent publication.

Moreover, PROP leadership participated in drafting the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. PROP Executive Director Dr. Andrew Kolodny disclosed his involvement, but PROP President Dr. Jane Ballantyne and PROP Vice President Dr. Gary Franklin did not list the group as a relevant conflict of interest on their disclosure forms.

The Steve Rummler Hope Foundation is the “fiscal sponsor” of PROP. Its vision is “a world where individuals with chronic pain receive integrated care focused on wellness rather than drugs.” For patients with moderate or severe pain, this can hardly be an effective and humane treatment. PROP’s close ties with the Steve Rummler Foundation are revealed by Dr. Kolodny’s and Dr. Ballantyne’s membership on its medical advisory committee.

Policies Should Balance All Public Health Interests

Indeed, it is correct to attend to the non-medical use of psychoactive substances. However, the situation outside the U.S. is really different. In many countries, patients have no access to adequate pain management. Measures to address non-medical use of opioids should not hamper access to effective pain management.

Policymakers in countries with a low per capita medical opioid consumption and low prescription rates should first analyse how prescription opioids that have not been prescribed enter circulation. The relationship between the non-medical use of prescription opioids and illicitly produced substances such as heroin should also be taken into consideration. Then, appropriate interventions to halt the diversion should be developed.

In parallel, policymakers should develop policies aimed at ensuring adequate provision of pain treatment as recommended by the World Health Organization. Optimal public health outcomes can only be attained when policies to minimize non-medical use are balanced with policies to maximize access to adequate pain management. Crafting such policies entails correctly distinguishing between prescribed and prescription opioids.

Willem Scholten, PharmD MPA, is an independent consultant for medicines and controlled substances at Willem Scholten Consultancy in the Netherlands. This has included work for DrugScience, Grünenthal, Jazz Pharmaceuticals, Mundipharma, Pinney Associates and the World Health Organization. Dr. Scholten is also a board member of International Doctors for Healthier Drug Policies.

He wishes to acknowledge Dr. Katherine Pettus for her contribution to this article.

Pain News Network invites other readers to share their stories with us.  Send them 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.

The Media’s Addiction to Opioids

By Roger Chriss, Columnist

A recent and very brief CDC report described 59 pneumonia deaths in Minnesota between 2006 and 2015 that involved opioids. The gist of the study was that “opioid users are at increased risk for pneumonia” and therefore the deaths should have been reported as opioid related overdoses, even though the autopsy reports list pneumonia as the cause of death.

Vox said the study suggests “the opioid epidemic may be even deadlier than we think,” while the Daily Mail warned it was “just the tip of the iceberg” and that “we may have grossly underestimated the scale of the opioid epidemic.”

JAMA Surgery also recently published a study, which found that about 6 percent of surgery patients continued to use opioids more than three months after their surgery.

U.S. News cited the study to proclaim that “Many Opioid Addictions Surface After Surgery,” while MedicalXpress said it was proof that someone could go “from opioid-free to long-term user, in one operation.”

Both the CDC report and the JAMA Surgery study were grossly misrepresented. Fear sells, and the opioid crisis has become a favorite source of fear-mongering in the media.

The CDC report is a one page, four-paragraph document released by the agency’s Epidemic intelligence Service (EIS). It never mentions the words “addiction” or “epidemic,” yet it leaps to one very big conclusion.

“The total burden of opioid-associated deaths was underestimated in Minnesota,” the report says. “The contributions of opioid toxicity, infectious disease, or their interactions to death are challenging to disentangle; understanding these interactions might inform future opioid-related mortality prevention efforts.”

The JAMA Surgery article is a retrospective study which found an association between post-operative use of opioid medications for pain management and patient history of smoking and alcohol use. The study looked at opioid abuse only as an exclusion criteria for the patient population; it was not a study about addiction in any form. The JAMA article concludes by saying that “new persistent opioid use represents a common but previously underappreciated surgical complication that warrants increased awareness.”

In other words, we have intriguing results that should be investigated further, with the ultimate goal of improving public health and welfare. Unfortunately, all that is lost in the alarmist media coverage that mischaracterizes the findings, over-interprets the data, and extrapolates consequences to reach what at best are highly premature conclusions.

In its coverage of the CDC report, CNN quoted EIS officer Victoria Hall, DVM, as saying that the Minnesota data represents “an iceberg of an epidemic.” 

Keep in mind that Hall is not an epidemiologist, an infectious disease specialist or an expert on icebergs. She is a veterinarian by training and a recent graduate of Mississippi State University's College of Veterinary Medicine. Hall has been working for the CDC less than a year, according to her LinkedIn profile.

In a CDC media briefing, Hall refers to only one specific case in Minnesota: a middle-aged man dying of pneumonia, who was on opioid therapy for chronic back pain. This case is not mentioned in the CDC EIS report. His death may be an important hint of a new facet of the opioid crisis, or it may be an anomalous outcome. More work is needed to figure out what is really going on. For now, it bears remembering that the plural of anecdote is not data.

VICTORIA HALL, DVM

Similarly, U.S. News reported on the JAMA Surgery article by stating that, “Some surgery patients prescribed opioids for post-operative pain relief may face a high risk for developing a long-term opioid addiction, new research warns.” This report also appeared on Philly.com  and on WebMD , spreading the misinformation about addiction risks, which were never even mentioned in the article.

In other words, there was a huge and speculative leap from the data in the CDC report about 59 opioid-related pneumonia deaths over a decade-long period all the way to a stealth epidemic sweeping the nation. And an equally large jump from an association between the duration of post-surgical opioid use and patient social history to a new source of opioid addiction.

The sensible response is to call for further research. For the CDC, this means collecting data from all 50 states about otherwise unexplained deaths and seeing if opioids are involved in any of them, then following up with analysis on possible under-reporting. For the world of surgery, this means performing prospective trials to see if the reported association holds up, and then investigating if such use increases the odds of a patient developing opioid use disorder.

For now, we just don’t have the data to figure out what is going on. And as Sherlock Holmes says: “It is a capital mistake to theorize before one has data.”

Roger Chriss suffers from 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.

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.

The Difference Between Addiction and Dependence

By Michael Thompson, Guest Columnist

When a person consumes alcohol or takes a mood altering medication, several things start to happen. First, they begin to develop a tolerance for it, so that over time it takes more of the drug to get the same effect. That can lead to abuse and addiction.

A person may also develop a dependence on a drug.  That means they have a clinical need for a medication.  

Many pain sufferers have found they need more opioid medication to provide relief from their pain, but that doesn’t mean they abuse or misuse it. It also doesn’t make them addicts.

I am dependent on my blood pressure medication to keep my blood pressure in check, but I’m not addicted it. Diabetics are dependent on their medication, but they are not addicted. 

Last year the CDC came out with opioid prescribing guidelines for general practitioners. But restricting the legal prescribing of these drugs will have no effect on the fact that most addicts don’t get their medication from Walgreens or Wal-Mart.  They get their drugs from Bobby the Rat behind Walgreens, or behind the pool hall from Billy the Snitch or Joe the Jerk.  What Bobby, Billy and Joe are selling is heroin, counterfeit painkillers and other illegal drugs.

What effect do these restrictive guidelines have on the illegal use of opioids?  None whatsoever.  The prescribing of opioid painkillers has been on the decline for years.  Most people who overdose are killing themselves with illegal drugs, not drugs obtained from their family doctor. 

Sure, everyone has heard of doctor shopping junkies who will go to an unscrupulous physician, who for $20 in cash will write an opioid prescription without even an examination. But the number of addicts pales in comparison to the number of legitimate chronic pain suffers who have been on these quality-of-life saving drugs for years without ever abusing their medications. Most have no idea where to find Bobby, Billy or Joe, or how to go about buying illegal drugs on the street.

Millions of older adults suffer from osteoarthritis and other neurologically painful conditions for which there is no cure, but there is treatment.  Many are on high doses of pain medication and have been taking these drugs for years, without ending up in the gutter shooting heroin or with a tag on the toe, lying on a tray in in the county medical examiner’s office.  They are not the ones causing headlines. 

Many doctors wrongly believe the CDC guidelines are rules that apply to all who prescribe opioid medication.  They fear that the DEA will come barging in if they go over a minimal amount, prosecute them and take away their license.  Their fear has left many chronic pain patients hanging out to dry, including some who will die because their pain is not being appropriately treated. 

If you have ever suffered from chronic, intense pain you are aware that it is all consuming.  It literally takes over your life.  Many, like me, who once led active lives on high doses of opioids, are now housebound, unable to shop, cook, clean or in many cases even just walk from the bedroom to the kitchen. 

It is a horrible existence, sitting in a chair all day, just trying to make it from morning to evening, and then unable to sleep because the pain is so intense.  Many of these once functional chronic pain sufferers have had their medication cut in half or more. 

As a personal example, I have two torn rotator cuffs that won’t heal.  I have had two surgeries that failed to correct the problem.  My surgeon says he won’t do any more surgeries because the rotator cuffs just continue to tear.  But that’s not all.  I have no cartilage left in my knees, a detached bicep tendon in my left elbow, and peripheral neuropathy in my feet and hands that causes them to burn and ache.  It’s been years since I was able to wear shoes. 

Before the CDC guidelines came out, I was on 6 pills of opioid medication a day.  I had been on this dose for five years and never once abused my medication or took more than was prescribed.  I was able to play golf and worked out three times a week, which helped me to keep my weight off.  When my pain specialist cut my dose in half, I literally crashed and burned.  Since then I have been practically home bound.  My story is similar to that of many other chronic pain sufferers.

So what do we do?  Practically every chronic pain patient has been running from one doctor to another, trying to find someone who will maintain them on the medication that helped them to live a somewhat normal life.  Imagine going to a new specialist, only to find the waiting room filled with dozens of other “new patients” trying to find someone, anyone, who wasn’t terrified of the DEA.

Is the CDC aware that their guidelines for primary care doctors have turned into rules for everyone?  Surely someone has told them about this.  Surely they know.

What’s to become of us?  Will we see a spike in the suicide rate of older adults who can no longer stand the daily struggle?  Will anyone care?

There are a lot of organizations that have tried to explain that the guidelines are not hard and fast rules and that they apply only to general practitioners. But fear is a stronger motivator than common sense. 

It cannot be that drug addicts are more important than patients. Don’t suffer in silence. Call, write a letter, or email your senators and congressman.

Don’t know who represents you in Congress? You can look them up by clicking here.

Michael Thompson is a retired clinical social worker and a licensed chemical dependency counselor. He lives in Texas.

Pain News Network invites other readers to share their stories with us.  Send them 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.

Will Pain Patients Participate in Drug Take Back Day?

By Pat Anson, Editor

Tomorrow is National Prescription Drug Take Back Day, an annual effort by the U.S. Drug Enforcement Administration to give people an opportunity to safely dispose of their unneeded and expired medications.

Last year the DEA and its local law enforcement partners collected nearly 900,000 pounds of unwanted medication – about 447 tons – at almost 5,400 collection sites in all 50 states.

“These results show that more Americans than ever are taking the important step of cleaning out their medicine cabinets and making homes safe from potential prescription drug abuse or theft,” said DEA Acting Administrator Chuck Rosenberg in a news release.

One of the main goals of the DEA is to get patients to dispose of unneeded opioid medication, to prevent the drugs from being stolen, shared or sold.

But with opioid medciation becoming harder to obtain due to federal and state guidelines – and the DEA itself reducing the supply of hydrocodone, oxycodone, and other painkillers by 25 percent or more --   are chronic pain patients going to participate in Drug Take Back Day?

A recent survey of over 3,100 patients by Pain News Network and the International Pain Foundation suggests that many will not. And that government efforts to limit the supply of opioids have turned many responsible patients into hoarders.

Nearly one in four patients – 22 percent – say they are hoarding opioid medications because they’re not sure if they’ll be able to get them in the future.

Nearly half say they are being prescribed a lower dose since the CDC released its controversial opioid guidelines, and almost one in four say they are no longer prescribed any opioids.

“The CDC guidelines have led to a lot of confusion and fear for patients and their doctors. If anything, I ask for more pain medication now because I don't know how much longer I'll be able to obtain it,” one patient wrote.

“I never abused my opiates and in fact have hoarded 30 precious pills,” said another patient.

“I am 65 years old, well educated, and very disabled by (fibromyalgia). I endure the pain, for as long as possible, (and only) then take the meds due to having to hoard the medication,” wrote another.

“It's a no win situation," said a patient. "To be able to get proper relief from a new injury or if surgery comes up, one must hoard enough to treat the additional pain or suffer through it.”

Although the supply of opioid medication has been in decline for years, the news media often makes it sound like painkillers are still being given out like candy, often relying on outdated or inaccurate information that doesn't reflect the current environment.

“The amount of prescription opioids consumed has quadrupled since 1999, and deaths are even higher. Since eight out of ten new heroin users began by abusing prescription painkillers, and most get their pills from family and friends, controlling access to the pills becomes increasingly important,” Judy Stone, MD, wrote in a Forbes article promoting Drug Take Back Day.

Yes, Dr. Stone, it is true that opioid overdoses are soaring, but in recent years that is primarily due to heroin and illicit fentanyl, not prescription opioids. Even the CDC admits that painkillers are no longer driving the opioid epidemic.

The DEA also tells us that less than one percent of legally prescribed painkillers are diverted, which means that 99% of pain patients are responsible about their use and storage of pain medication. Only a small percentage of patients become addicted to opioids and even fewer go on to use heroin.

All of which isn’t to say that Drug Take Back Day is a bad idea. But let’s not use it as another opportunity to stigmatize chronically ill patients who happen to need pain medication.

To find a drug collection site near you, click here.

Stem Cell Vaccine Could Reverse Arthritis

By Pat Anson, Editor

A team of researchers has successfully used gene-editing technology to “rewire” mouse stem cells to fight inflammation – a finding that could pave the way for a new class of biologic drug that replaces cartilage and protect joints from damage caused by arthritis.

The stem cells, known as “smart” cells (stem cells modified for autonomous regenerative therapy), were developed at Washington University School of Medicine and Shriners Hospitals for Children in St. Louis, in collaboration with investigators at Duke University and Cytex Therapeutics in North Carolina.

The research findings are published in the journal Stem Cell Reports.

"Our goal is to package the rewired stem cells as a vaccine for arthritis, which would deliver an anti-inflammatory drug to an arthritic joint but only when it is needed," said senior author Farshid Guilak, PhD, a professor of orthopedic surgery at Washington University School of Medicine.

Guilak and his colleagues grew mouse stem cells in a test tube and then used a gene-editing tool called CRISPR to remove a gene that plays a key role in inflammation. That gene was replaced with a gene that releases a biologic drug that combats inflammation.

Within a few days, the modified stem cells grew into cartilage cells and produced cartilage tissue. Further experiments showed that the engineered cartilage was protected from inflammation.

"We hijacked an inflammatory pathway to create cells that produced a protective drug," explained Jonathan Brunger, PhD, the paper's first author and a postdoctoral fellow in cellular and molecular pharmacology at the University of California, San Francisco.

IMAGE CREDIT: ELLA MARUSHCHENKO

Many current biologic drugs used to treat arthritis – such as Enbrel, Humira and Remicade -- attack an inflammation-promoting molecule called TNF-alpha. But the problem with these drugs is that they interfere with the immune system throughout the body and can make patients susceptible to side effects such as infections.

"We want to use our gene-editing technology as a way to deliver targeted therapy in response to localized inflammation in a joint, as opposed to current drug therapies that can interfere with the inflammatory response through the entire body," said Guilak. “If this strategy proves to be successful, the engineered cells only would block inflammation when inflammatory signals are released, such as during an arthritic flare in that joint."

Researchers have begun testing the engineered stem cells in mouse models of rheumatoid arthritis and other inflammatory diseases. If the work can be replicated in living laboratory animals and then developed into a clinical therapy, the cartilage grown from stem cells would respond to inflammation by releasing a drug that protects them from further damage.

"When these cells see TNF-alpha, they rapidly activate a therapy that reduces inflammation," Guilak explained. "We believe this strategy also may work for other systems that depend on a feedback loop. In diabetes, for example, it's possible we could make stem cells that would sense glucose and turn on insulin in response.

"The ability to build living tissues from 'smart' stem cells that precisely respond to their environment opens up exciting possibilities for investigation in regenerative medicine."

Farshid Guilak and co-author Vincent Willard have a financial interest in Cytex Therapeutics, a startup founded by some of the investigators. They may license the technology and realize financial gain if it is eventually is approved for clinical use.

Guilak and his colleagues at Cytex have also used stem cells to grow new cartilage that could someday be implanted into arthritic hips, delaying or eliminating the need for hip replacement surgery.

Stem cells are found throughout the body and are increasingly being used to develop new treatments to repair damaged tissue and reduce inflammation. The Food and Drug Administration considers most stem cell treatments experimental because their safety and efficacy haven’t been proven through clinical studies.