New Guidelines Offer Little Relief for Back Pain

By Pat Anson, Editor

“Take two aspirin and call me in the morning” doesn’t cut it anymore for low back pain. In fact, very little does.

One in four adults will experience low back pain in the next three months, making it one of the most common reasons for Americans to visit a doctor. But when it comes to treating low back pain, the American College of Physicians (ACP) says the evidence is weak for many pharmaceutical and non-drug therapies.

In fact, the best treatment for acute low back pain may be none at all.

"Physicians should reassure their patients that acute and subacute low back pain usually improves over time regardless of treatment," said Nitin Damle, MD, president of ACP. "Physicians should avoid prescribing unnecessary tests and costly and potentially harmful drugs, especially narcotics, for these patients."

An ACP review committee analyzed dozens of clinical studies to arrive at new guidelines for treating acute back pain (pain lasting less than 4 weeks), subacute back pain (pain lasting 4 to 12 weeks) and chronic back pain (pain lasting more than 12 weeks).  

The ACP recommends that doctors start with non-drug therapies, such as exercise and superficial heat with a heating pad, along with massage, acupuncture, spinal manipulation (chiropractic), tai chi, and yoga. The evidence for the effectiveness of exercise and superficial heat was considered moderate, while the evidence for the other non-drug treatments was considered low quality.

Only when non-drug treatments have failed does the ACP recommend medication for chronic low back pain, starting with non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and aspirin. Tramadol (a mild acting opioid) and duloxetine (Cymbalta) are recommended as second line therapies. The ACP says physicians should only consider stronger opioids as a third line therapy when all other treatments have failed.

The evidence for the effectiveness of NSAIDs and opioids was classified as moderate, while the evidence for acetaminophen, benzodiazepines and systemic steroids was considered low-quality.

"For the treatment of chronic low back pain, physicians should select therapies that have the fewest harms and costs, since there were no clear comparative advantages for most treatments compared to one another," Damle said.

The ACP guidelines say surprisingly little about the documented risks associated with NSAIDs, such as cardiovascular and gastrointestinal problems. The guidelines refer only vaguely to “moderate quality evidence” that NSAIDs have “adverse effects.”

Short-term use of opioids for low back pain was linked to increased nausea, dizziness, constipation, vomiting, somnolence and dry mouth. Interestingly, addiction and overdose were not listed as potential risks because they were not studied.

“Studies assessing opioids for the treatment of chronic low back pain did not address the risk for addiction, abuse, or overdose, although observational studies have shown a dose-dependent relationship between opioid use for chronic pain and serious harms,” the guideline states.

The ACP guidelines were released one week after Australian researchers released their own evaluation of NSAIDs in treating back pain. Their study found that NSAIDs reduced pain and disability somewhat better than a placebo, but the results were not statistically important (see “Ibuprofen No Better Than Placebo for Back Pain”).

The ACP calls itself the largest medical specialty organization in the United States. ACP members include 148,000 internal medicine physicians (internists), related sub-specialists and medical students.

The new guidelines are published in the Annals of Internal Medicine.

Four Years of Chronic Pain

By Crystal Lindell, Columnist

This month marks four years since I first woke up with random pain in my right ribs.

Sometimes it feels shorter than that. Sometimes, it feels so much longer.

I didn’t want to write this column. I didn’t want to acknowledge this anniversary.

I’ve been doing so much better lately. The pain, which is likely intercostal neuralgia, is way more under control than it used to be, thanks in large part, I believe, to getting my Vitamin D levels into the normal range.

But it lingers, it’s always there, like a black shadow and a heavy cinder block, pulling me back.

And after taking myself from 60 mg of opioids a day down to 5 mg, I decided this month to go back up a bit because the pain has been too much to bear. After talking with my doctor, we decided to go with 10 mg a day.

It feels like defeat.

I don’t know why the pain seems to be worse these days. It could be stress, it could be the weather, or it could just be because I wear Mac red lipstick almost daily now — it all really does feel that arbitrary.

And even though I try to manage all the possible triggers, sometimes it just flares up and leaves me unable to get out of bed. On those days, even the hydrocodone doesn’t touch it.

It’s frustrating. And I thought maybe if I didn’t write this column — if I just ignored the four-year mark — I could pretend I was actually all better.

I’m not though. Obviously, I’m not.

The pain still impacts so much of my daily life. I still factor in time to rest after a shower. I still make careful calculations about how much driving I can really do in a day before the pain gets too bad. And I still take lots of sick time from work.

I spend more time than I should counting hydrocodone pills and figuring out which bras hurt the least and avoiding hugs.

I do feel like I’m better than I was though. I’m completely off morphine, which feels like a victory. And most of the time, the pain is completely manageable with a very small dose of hydrocodone. Also, I’m lucky in that I can fake being well long enough that most of the time it doesn’t really impact how others see me. Most people have no idea I struggle with health issues unless I outright tell them.

It’s been a long four years. And I wouldn’t wish chronic pain on anyone. All of the good things — all of the ways I’ve learned to be more compassionate, all of the writing it has inspired, all of the bonds it helped me cement with family and friends who helped me out — I would give it all back if I could live without pain.

Alas, that is not my fate. This is my fate. A constant battle between living like a healthy person and feeling like a sick person. Medical bills. Driving two hours each way to see specialists. Sleeping only on my left side. This is my life. 

But at least I have my Mac red lipstick. Even the rib pain can’t take that away from me.

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.

Does Changing Your Diet Help With Fibromyalgia?

By Lana Barhum, Columnist

Having lived with fibromyalgia most of my adult life, I know my diet may worsen or improve my pain and other fibromyalgia symptoms. I am not alone in this belief, but the research disagrees. 

Most studies have not shown any specific evidence that fibromyalgia patients should avoid certain foods or add any to their diets to manage symptoms.  Nonetheless, it is still a good idea to take a look at how some foods influence how you feel.

MSG, Gluten and Vitamin D

At least 42% of fibromyalgia patients have reported worsening symptoms after eating certain foods, according to a study in Clinical Rheumatology.  Other studies on fibromyalgia and diet have focused on food additives, gluten, and vitamin D, and found some evidence that they may affect fibromyalgia pain.  

A 2012 study published in Clinical Experimental Rheumatology, assessed fibromyalgia and irritable bowel syndrome (IBS) patients who had excluded monosodium glutamate (MSG) and aspartame from their diets.  After four weeks, 84% of the study participants reported their symptoms had improved by about a third.  Adding MSG back into their diets resulted in a return of symptoms.

The researchers concluded that MSG did, in fact, have an adverse effect on some fibromyalgia patients and removing it from their diets was an easy solution.

"This novel research implicates glutamate as a major adverse excitotoxin in some FM (fibromyalgia) patients. Dietary manipulation is a relatively simple and low cost non-pharmacological intervention that warrants further exploration," reported lead author Kathleen  Holton, PhD.

But another study, published in Rheumatology International, found no relationship between MSG and fibromyalgia pain and symptoms.  The researchers reported no symptom improvement in the group that removed MSG and aspartame from their diets and the group that did not.

While there has been little specific evidence pointing to gluten as a fibromyalgia trigger, some research shows patients respond well when they avoid eating gluten.  Spanish researchers reported in Rheumatology International that fibromyalgia patients who removed gluten from their diets showed notable improvements in pain and symptoms.                                                           

There may also be a link between fibromyalgia pain and low levels of vitamin D, according to a 2014 study out of Austria. That research, reported in the journal Pain, found that study participants who took vitamin D supplements experienced less pain and morning fatigue.   

A 2015 report from the journal Pain and Therapy, also makes a case for a link between Vitamin D deficiency and pain. "Significant improvements in assessment of sleep, mood, pain levels, well-being, and various aspects of quality of life with vitamin D supplementation have been shown,” said researchers Elspeth and Edward Shipton.

More research is needed to further determine if diet and fibromyalgia are actually related.  But doctors do agree eating healthy foods can help patients to feel better and tweaking your diet may improve symptoms.

Making Diet Changes

Here are some ways to help you figure out which foods help and which ones hurt.

Keep a Food Journal.  Many people with fibromyalgia have food sensitivities, but specific “trigger” foods will vary from person to person.  A good way to identify which foods worsen fibromyalgia symptoms and pain is to keep a food journal.  If you find your symptoms consistently worsen after eating certain foods, try eliminating those foods from your diet and see if your symptoms improve.

Eat Healthy. It makes sense for everyone to eat healthy, not just people with fibromyalgia.  Eat a diet that is rich in fruits and vegetables, whole grains, and lean proteins. 

A balanced diet will also give you more energy and improve overall health.

Pick the Right Foods. There are certain foods that may help improve fibromyalgia symptoms and minimize flares.  Vitamin D is one, as studies show deficiency can cause joint and muscle pain.

Vitamin D is one, as studies show deficiency can cause joint and muscle pain. Foods rich in vitamin D include fatty fish (tuna and salmon), dairy products fortified with vitamin D (orange juice, milk, and cereal), beef liver, and egg yolks. Foods containing omega 3 fatty acids, which are found in fatty fish, walnuts and flax seed, may also ease fibromyalgia symptoms by reducing soreness and inflammation.  

My Take

I am strong believer in taking your health into your own hands and experimenting with alternative treatments, including a healthy diet.  Through trial and error, I have figured out which foods help and which foods hurt as I continue to learn how to successfully cope with fibromyalgia. 

Aspartame (Nutrasweet), food additives (especially MSG), sugar, fructose, simple carbohydrates, caffeine, gluten, fried and junk food, dairy and nightshades (tomatoes, peppers, and potatoes) are all foods that I have either eliminated or minimized from my diet.  Cutting them out of my diet has made fibromyalgia flares less frequent. 

In addition, I take vitamin D supplements, since my levels are often low, and eat foods rich in omega 3 fatty acids, such as fish, walnuts, and eggs, to manage inflammation, as I also suffer from rheumatoid arthritis.

While I don’t know for certain if my diet is the reason for fewer flare-ups, I do know that avoiding certain foods and eating healthy ones benefits my overall health.  And when my body feels healthier, I am better able to cope with fibromyalgia pain and symptoms.

The specific foods that help and hurt will be different for you, but a healthy diet can help you manage fibromyalgia symptoms and pain and improve your health overall.  And, it is definitely worth a try to find out. 

Lana Barhum is a freelance medical writer, patient advocate, legal assistant and mother. Having lived with rheumatoid arthritis and fibromyalgia since 2008, Lana uses her experiences to share expert advice on living successfully with chronic illness. She has written for several online health communities, including Alliance Health, Upwell, Mango Health, and The Mighty.

To learn more about Lana, visit her website.

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

Should I Tell Someone About My Invisible Illness?

By Barby Ingle, Columnist

It can be tricky deciding when to tell someone about your chronic pain or invisible illness. You can never take back information once it is shared.

If you choose to disclose that you have a chronic condition or disability, you should decide when and how to do it. Take the time to think about different situations and how you wish to handle them.

Many people feel it is not their place to ask about your physical conditions, but knowing about your pain and limitations could help them understand where you are coming from with your thoughts and actions.

I know a chronic pain patient who liked a neighbor and was interested in dating him.  He often helped around her house with handyman projects, and she would see him out on his porch and go out and talk to him. Eventually, he asked her out and they had a great time.

Over the next few months, they had dates scheduled but she ended up canceling a lot of them. She was just in too much pain. He began to think she was not interested in him and started to pull away.

Friends encouraged her to tell him about her medical condition and what she was going through. She did, and he stuck around for a while, but in the end it did not work out. However, they remained friends and it helped her see that she could still have a social life.

If you’re in this or another social situation, you should think about the following when deciding whether to disclose your condition and how it affects you:

• Are you able to participate in activities using your coping skills and tools?
• Do you need accommodations?
• Are you able to perform the activity safely if you choose not to disclose?
• Do you think the other person will react in a way that’s appropriate for where you are?

If you are not sure about the latter, you may want to wait until you are in a private setting.

If the situation becomes an intimate relationship, it is very important to share even if it means losing that person. It is not fair to them or you to hold that information back.

If your disability is in remission or typically under control, is there a reason to disclose? It is possible that flare-ups may keep you from future activities, so it would be a good thing to disclose ahead of time. The education you give them may also help someone else they meet along the way.

Finally, how will you address misconceptions about your chronic condition when you disclose? Some people do not believe in treating pain with narcotic medications or had a bad experience with someone else in their life with chronic pain.   

Not disclosing is wrong if you are in a situation that can cause others harm. For instance, when getting on a plane, you shouldn’t be sitting in the exit row. If assigned by mistake, notify the flight crew.

When choosing situations and activities where you do not want to disclose your disability, take time to carefully analyze the activities you are able to do and plan accordingly. Remember, you can always reveal more information later as needed.

Sex, Poverty and Education Linked to Chronic Pain

By Pat Anson, Editor

If you are female, poor and never finished high school, you are much more likely to suffer from chronic pain than other Americans, according to a new study published in the journal Pain.

“Women, the less educated, and the less wealthy experience not only more pain, but also more severe pain, as well as greater disability, said Hanna Grol-Prokopczyk, an assistant professor of sociology at the University of Buffalo.

Grol-Prokopczyk studied over 12 years of data from nearly 20,000 Americans aged 51 and over, who participated in the national Health and Retirement Study from 1998 to 2010.

Her research uncovered some unexpected findings about chronic pain in the United States.

She found that the severity and frequency of pain is increasing in older adults. People who were in their 60’s in 2010 reported more pain than people who were in their 60’s in 1998.

“There are a lot of pressures right now to reduce opioid prescription,” says Grol-Prokopczyk. “In part, this study should be a reminder that many people are legitimately suffering from pain. Health care providers shouldn’t assume that someone who shows up in their office complaining of pain is just trying to get an opioid prescription.

“We have to remember that pain is a legitimate and widespread problem,” she added.

The study is among the first to measure chronic pain by degree. Participants were asked whether their pain was mild, moderate or severe, and if they were “often troubled with pain.” Participants were followed for over 12 years, as opposed to most studies that follow patients over a much shorter period.

“I found that people with lower levels of education and wealth don’t just have more pain, they also have more severe pain,” she says. “I also looked at pain-related disability, meaning that pain is interfering with the ability to do normal work or household activities.  And again, people with less wealth and education are more likely to experience this disability.”

About one out of every four people who didn’t finish high school said their pain was severe, while only 10 percent of those with college graduate degrees did so.

About 8 percent of African Americans and Hispanics said their pain was severe, compared to about 5 percent of whites.

“If you’re looking at all pain – mild, moderate and severe combined – you do see a difference across socioeconomic groups. And other studies have shown that.  But if you look at the most severe pain, which happens to be the pain most associated with disability and death, then the socioeconomically disadvantaged are much, much more likely to experience it,” said Grol-Prokopczyk.

More research needs to be done to understand why pain is so unequally distributed in the population, and Grol-Prokopczyk says it’s critical to keep the high burden of pain in mind as the nation grapples with an overdose epidemic.

“We don’t have particularly good treatments for chronic pain. If opioids are to some extent being taken off the table, it becomes even more important to find other ways of addressing this big public health problem,” she said. “If we as a society decide that opioid analgesics are often too high risk as a treatment for chronic pain, then we need to invest in other effective treatments for chronic pain, and/or figure out how to prevent it in the first place.”

How We Can Stop Medicare’s ‘Big Brother’ Opioid Policy

By Rick Martin, Guest Columnist

How many readers who leave comments on PNN are doing more than just commenting?

Change takes work if the pain community is going to stop the Centers for Medicare and Medicaid Services (CMS) from making the CDC’s opioid prescribing guidelines mandatory for millions of Medicare patients, including a ban on daily doses higher than 90 mg morphine equivalent (see “Medicare Planning to Adopt CDC Opioid Guidelines”).

We don’t need CMS and the insurance industry dictating what medication a physician can prescribe for pain or the appropriate amount of medication needed (see "Insurers Behind Medicare's 'Big Brother' Opioid Policy").

In my opinion, this is what needs to be done:

We have to start a chain letter.

I propose a form letter that everyone can copy and paste, forward, fax and mail to friends, family, caregivers, bloggers, Facebook, Twitter, and any other viable means of communication.  

You have to send it to at least 10 people. And ask them to send it to 10 people they know.

The letter also needs to be sent to patient advocacy groups like the U.S. Pain Foundation, American Chronic Pain Association, International Pain Foundation and the Alliance for Balanced Pain Management, a coalition of advocacy groups. They can post it in their newsletters and alert their members to what CMS is doing. This is the only way to reach a huge amount of people in a short amount of time. 

Here are their email addresses:

• U.S. Pain Foundation:  contact@uspainfoundation.org 
• American Chronic Pain Association:  acpa@theacpa.org 
• International Pain Foundation:  info@internationalpain.org 
• Alliance for Balanced Pain Management:  info@alliancebpm.org

We need to rein in CMS from dictating how we should live and the ability of our physicians to treat us. It won’t be easy. It took me 27 letters to the CDC to get a response from Dr. Debra Houry, who helped draft the agency’s guidelines.  

CMS is only accepting emailed public comments to their proposal until March 3, 2017. They will publish the final rules on April 3, so there is not much time. We must all act NOW.

Here is what I am emailing to CMS at this email address: AdvanceNotice2018@cms.hhs.gov

To Whom It May Concern:

I oppose the Centers for Medicare and Medicaid Services’ plan to align its policies with the CDC Guideline for Prescribing Opioids for Chronic Pain.

The CDC guideline is voluntary and gives physicians discretion in determining what is right for their patients. However, your policy as presently drafted will make the guidelines mandatory for all doctors, patients and pharmacists, and impose a ceiling on the highest dose of opioids that can be prescribed. That was never the CDC’s intent. 

On June 1, 2016, Dr. Debra Houry, Director of the CDC’s National Center for Injury Prevention
and Control, wrote the following:

“The Guideline is a set of voluntary recommendations intended to guide primary care providers as they work in consultation with their patients to address chronic pain. Specifically, the Guideline includes a recommendation to taper or reduce dosage only when patient harm outweighs patient benefit of opioid therapy. The Guideline is not a rule, regulation, or law. It is not intended to deny access to opioid pain medication as an option for pain management. It is not intended to take away physician discretion and decision-making.”

The following are additional quotes from the CDC Guideline itself:

"Clinicians should consider the circumstances and unique needs of each patient when providing
care.”

"Clinical decision making should be based on a relationship between the clinician and patient,
and an understanding of the patient's clinical situation, functioning, and life context."

"The Guideline provides recommendations for primary care providers who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care and end-of-life-care."

Your policy does not provide an exception for palliative care, only patients receiving cancer treatment or end-of-life care. In my opinion, that is a blatant omission.

The facts are also available showing there has been collusion between the insurance industry and CMS in drafting your new “Opioid Misuse Strategy.”

For all of these reasons and more, CMS should not adopt or align your agency’s policies with the CDC Guideline, as it is apparent you have misinterpreted them.

Sincerely,

Rick Martin

Feel free to copy my letter or make changes to express your own views. It also might be helpful to attach a copy of Dr. Houry’s letter in your email. If anyone wants a copy of her letter, click here to download it.

Time is running out if we want to put a stop to this.

Rick Martin is a retired pharmacist in Nevada who was disabled by chronic back pain.

Pain News Network invites other readers to share their opinions and 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.

Ibuprofen No Better Than Placebo for Back Pain

By Pat Anson, Editor

When it comes to treating back pain, anti-inflammatory drugs such as ibuprofen work no better than a placebo, according to new Australian study.

Researchers at the University of Sydney conducted a meta-analysis (a study of studies) of 35 clinical trials involving over 6,000 people with back pain, and found that non-steroidal anti-inflammatory drugs (NSAIDs) provide little benefit. The study was published in the Annals of the Rheumatic Diseases.

“NSAIDs are effective for spinal pain, but the magnitude of the difference in outcomes between the intervention and placebo groups is not clinically important. At present, there are no simple analgesics that provide clinically important effects for spinal pain over placebo,” wrote lead author Gustavo Machado, PhD, of The George Institute for Global Health. “There is an urgent need to develop new drug therapies for this condition.”

Back pain is the world’s leading cause of disability, with about 80 percent of adults experiencing back pain at some point in their lives.

Opioids are usually not prescribed for simple back pain, leaving patients little alternative but over-the-counter pain relievers such as NSAIDs, a class of drugs that includes both aspirin and ibuprofen. NSAIDs are known to raise the risk of gastrointestinal and cardiovascular problems.

The Australian study found that NSAIDs reduced pain and disability somewhat better than a placebo or dummy medication, but the results were not statistically important.

"NSAIDs do not provide a clinically important effect on spinal pain, and six patients must be treated with NSAIDs for one patient to achieve a clinically important benefit in the short-term," wrote Machado. “When this result is taken together with those from recent reviews on paracetamol (acetaminophen) and opioids, it is now clear that the three most widely used, and guideline-recommended medicines for spinal pain do not provide clinically important effects over placebo.”

The study did not evaluate non-pharmacological treatments for back pain, such as exercise, physical therapy or chiropractic care.

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are found in so many different products -- such as ibuprofen, Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

Misuse of Opioid Medication a Worldwide Problem

By Pat Anson, Editor

We hear often about the recreational or “non-medical” use of prescription drugs, particularly opioids, in the United States and Canada. But a new study published in the journal World Psychiatry suggests the abuse and misuse of opioids is a problem around the world.

Researchers at Columbia University's Mailman School of Public Health studied surveys of teenagers and young adults in Europe, Latin America, Asia, Middle East and the U.S.  They found that from 2000 to 2014, there was a 200 percent increase worldwide in overdose deaths due to opioids.

“Data on high school or university students from the Middle East or Arab world indicate that nonmedical use of prescription drugs warrants closer attention,” said lead author Silvia Martins, MD, associate professor of Epidemiology at Columbia University's Mailman School of Public Health.

“In Beirut, Lebanon, past-year nonmedical use of any prescription drugs was 21.6% among private university students and 10% among high school students. In both populations, prescription opioids were the drugs most commonly used nonmedically. In Saudi Arabia, a recent school-based survey showed a lifetime prevalence of 7.2% for the nonmedical use of any prescription drug.”

The growing misuse of opioid medication in some countries comes at a time when there is less misuse in the United States. A recent large survey found that 4.8% of American high school seniors had misused an opioid pain reliever in the past year, down from a peak of 9.5% in 2004. In the past five years, misuse of opioid pain medication by American 12th graders has declined by 45 percent.

Martins and her co-author say the availability of prescription opioids can vary widely from one country to another. Societal attitudes about medications and the misconception that they are “safe” can also contribute to misuse.

“The biggest challenge is balancing a country’s need to make available prescription drugs to those in need (i.e., those with chronic pain), while simultaneously curbing diversion and nonmedical use,” Martins wrote. “Another challenge is controlling the top most reported sources of supply, including parents, doctors and friends.”

A recent DEA report said the diversion of prescription opioids in the U.S. has fallen dramatically in the last few years, with less than one percent of legally prescribed opioids being diverted. The prescribing and abuse of opioid medication is also declining, along with the number of admissions to treatment centers for painkiller addiction. Despite these trends, which are rarely reported in the mass media, overdoses from heroin and other illegal opioids are soaring.

The DEA is planning to cut the supply of opioids even further in 2017, by reducing the supply of hydrocodone and other Schedule II opioids by 25 percent or more.

Trump Administration Promises Relief to Patients

By Pat Anson, Editor

A spokesman for the Trump administration pledged this week that the Department of Health and Human Services (HHS) would provide relief to patients who are "being harmed by the status quo.”

Matt Lloyd, a former top aide to Vice President Mike Pence, recently assumed the job of chief spokesman for HHS, the federal department that oversees the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services (CMS).

Lloyd made his comment in an unusual statement emailed to reporters after CMS released a report Friday that showed the number of Americans who signed up for insurance during Obamacare’s annual enrollment period had fallen to 9.2 million. That’s down from 9.6 million the year before.  

“Obamacare has failed the American people, with one broken promise after another. As noted in the report today from CMS, premiums in the ACA marketplace have increased 25 percent while the number of insurers has declined 28 percent over the past year,” Lloyd said.

MATT LLOYD

“We look forward to providing relief to those who are being harmed by the status quo and pursuing patient-centered solutions that will work for the American people.”  

Ironically, Lloyd made his statement two days after CMS invited public comment on the agency’s plans to have Medicare adopt the CDC’s opioid prescribing guidelines – a move that could affect thousands of patients who use opioids for pain relief. The CDC guidelines are voluntary and only intended for primary care physicians, but CMS wants to apply them to all doctors who prescribe opioids for non-cancer pain. A strict daily limit on opioids would also be set at 90 mg of a morphine equivalent dose.

Doctors and patients who don’t follow the proposed CMS policy could face punitive action, such as being dropped from Medicare coverage and insurance networks. CMS has estimated that over 15,000 Medicare beneficiaries who receive high doses of opioids for pain relief could be impacted  

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare.

The agency’s “Opioid Misuse Strategy” was developed during the final months of the Obama administration, but could be quickly adopted by the new administration.  CMS is only accepting public comments on its proposals until March 3 and plans to publish the final rules by Monday, April 3, 2017.

Comments on the CMS rule change should be mailed to:  AdvanceNotice2018@cms.hhs.gov.

Comments can be emailed to Matt Lloyd at: Matt.Lloyd@hhs.gov.

Medicare Planning to Adopt CDC Opioid Guidelines

By Pat Anson, Editor

The Centers for Medicare and Medicaid Services (CMS) has announced plans to fully implement the opioid prescribing guidelines released by the Centers for Disease Control and Prevention, which recommend that doctors not prescribe opioid medication for chronic non-cancer pain.

CMS is taking the CDC’s voluntary guidelines one step further, however, by mandating them as official Medicare policy and taking punitive action against doctors and patients who don’t follow them.

“When CDC released its guideline, I predicted that policymakers and payers would quickly move to convert CDC's voluntary recommendations into mandatory regulations, and my prediction appears to be coming true, both with CMS and with private payers,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

As Pain News Network has reported, CMS is adopting a “Big Brother” approach to fighting opioid abuse by developing a strategy that will encourage pharmacists to report doctors who may be overprescribing opioids and patients who may be abusing them. Information about these “potential opioid overutilizers” would be shared with insurance companies, which would be empowered to “prevent opioid overuse at point of sale at the pharmacy.”

CMS contracts with dozens of private insurance companies – known as sponsors -- to provide health insurance to about 54 million Americans through Medicare and nearly 70 million in Medicaid.

“To address the opioid epidemic, CMS has implemented a medication safety approach by which sponsors are expected to reduce beneficiary overutilization of opioids and maintain access to needed medications,” the agency said in a statement.

Saying it wanted to “better align” its policies with the CDC guidelines, CMS is proposing a daily ceiling on prescribed opioids at 90 mg morphine equivalent dose (MED). Any dosage above that level would be considered excessive. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged.

Insurers would be expected to police pharmacies, doctors and patients who do not follow CMS policies, potentially dropping them from Medicare coverage and their insurance networks.

“Under the Part D opioid overutilization policy, sponsors are expected to implement appropriate plan-level claim controls at POS (point of sale) for opioids, use improved retrospective drug utilization review to identify beneficiaries at high risk for an adverse event due to opioids, and perform case management with the identified beneficiaries’ prescribers followed by beneficiary-specific POS edits to prevent Part D coverage of opioid overutilization,” CMS said.

Such a policy change would have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved. The Veterans Administration is the only other federal agency to adopt the CDC guidelines – and many veterans have complained that they are no longer able to obtain adequate pain relief at VA facilities.

Critics of the CMS strategy say it is even more draconian than the CDC guidelines, which are intended only for primary care physicians.

“CDC's ‘soft limit’ of 90 MED in treating chronic pain was a recommendation aimed at treatment of some people with chronic pain by primary care specialists. CDC stated that all of its recommendations were voluntary, and in this case, further provided prescribers with the option to use a higher dose if indicated by a careful risk/benefit analysis,” Twillman said in an email to PNN.

“In light of these limitations, it seems inappropriate for CMS to ask Part D providers to institute opioid dosing limits for people with pain who don't have cancer or are receiving hospice care, and for all prescribers, both primary care and specialists. 

Strategy Developed by Insurance Industry

The agency’s proposed “Opioid Misuse Strategy” was released publicly in early January.  It closely follows a 62-page “white paper” prepared by the Healthcare Fraud Prevention Partnership (HFPP), a coalition of private insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud. 

The white paper, however, goes far beyond fraud prevention by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed. 

The number of Medicare patients who “overutilize” opioids is relatively small – just 15,651 beneficiaries in 2015 – which represents just 0.13% of Part D opioid users.

CMS is seeking public comment on the proposal in its 2018 Advance Notice and Draft Call Letter, which outlines a number of other changes the agency is making to its Medicare Advantage and Part D prescription drug programs. Comments will be accepted through March 3rd, with final versions published on April 3, 2017.

Comments can be emailed to: AdvanceNotice2018@cms.hhs.gov. 

When Will Doctors Speak Out for Their Pain Patients?

By Michael Thompson, Guest Columnist

I am a retired clinical social worker and a licensed chemical dependency counselor.

I had to retire about six years ago, at age 62, when my rotator cuffs started shredding on a chronic basis.  I also have osteoarthritis in both knees and peripheral neuropathy with severe pain in both feet and hands.  It’s been several years since I was able to wear shoes.   

I have also been diagnosed with Chronic Regional Pain Syndrome, which just means we don’t know what the problem is but were just going to call it blah, blah, blah.  That’s medicine for you – an art, not a science.

I am allergic to non-steroidal anti-inflammatory pain medication.  The last time I took naproxen, my blood pressure (which is normally high) dropped to 80/50.  I literally saw the pearly gates.  I ended up in the hospital for about a week. 

To put it lightly, my genes are rotten.  Everything seems to be breaking down in the latter years of my life and it all hurts. 

For about six years I was on a relatively high dose of opioid pain medication. Life wasn’t great, but it was pretty good.  I was able to play golf and work out three times a week in a physical therapy program.  I could work in the yard and around the house. Despite all of my multiple medical problems, I had an acceptable quality of life. 

MICHAEL THOMPSON

Then last year the CDC guidelines for opioid prescribing came out. My pain specialist freaked out and abruptly informed me that in order to keep the DEA from her door, she was going to have to reduce the amount of opiate medication she was prescribing for me.  My dose was cut in half.

In less than a month, I cratered.  I was in such intense pain 24 hours a day that I couldn’t sleep.  I couldn’t function.  My quality of life went from decent to nonexistent.  I was no longer able to work out and gained a good deal of weight. I couldn’t walk across the room because of extreme pain.  I spent my time at home waiting until it was time to take my next dose of medication. 

I tried changing my schedule, so that instead of taking a pill every six hours I would take one when I really needed it for severe pain. That seemed to work better, but I wound up taking more pills than I should and came up short at the end of the month. I was left for 48 hours with no medication at all. 

Even though I had never abused my medication, my pain doctor refused to help me out with an early refill, saying that it was just too bad and that the DEA would not let her write a new script even a half a day before it was due.  

I was stunned, though I should have known better.  For two days I thought I was going to die.  It wasn’t just the withdrawal. It was the unmasked intense pain. 

I worked for a time early in my career with an addiction physician who taught me that chemical dependence was a lot easier to treat than chronic pain, because of the all-consuming nature of pain.  He told me that with addiction you might wish you were going to die, but with the strain that untreated pain puts on the body, you might actually die.  After experiencing both, I can vouch for the truth of his words.

Needless to say, I have not made that mistake again.  Since that time I have maintained a strict regimen, even if that meant that I would have to white knuckle the last few hours before the next dose is due.

When I saw my doctor last month, she told me that the DEA had instructed her that she could not prescribe more than three pills a day to any of her patients.  Next time I see her, she will reduce me to four pills a day.  The month after that, she will only prescribe three a day. 

I don’t know what I am going to do when that happens.  It terrifies me.  I have never considered suicide as an option, but when a person is without hope that things will improve and they face intense grinding pain 24/7, I can understand how some people might find suicide appealing.  As a therapist, I never thought that I could understand that kind of thinking, but I do.

I asked for a referral to a psychiatrist because of her suggestion that with their advanced training, they might be able to prescribe more medication or a different opiate that works better. 

The psychiatrist I was referred to was the CEO of a local rehab program.  When he discovered that I was retired and on Medicare, and that I didn’t have a generous insurance package for rehab, his manner changed abruptly.  He treated me like I was a med seeking (which I was) and stone cold junky (which I was not). 

After an extremely presumptuous and rude exchange (it was clear that he was trying to impress his two cute interns and to show them just how you handle addicts), I informed him that I just did not feel that we were a good fit and left. 

It was clear that he knew nothing about my background or my history. And when he found out I didn’t have insurance money to feed his program, he lost interest in finding out anything about me.  I pity his patients and his employees. 

My next step was to seek a second referral. The doctor I was sent to was another pain specialist, who informed me that she was only prescribing two pills a day to her current patients, and so I should stay with my current provider.

I don’t know whether the issue has been a poor roll out of the CDC guidelines or if doctors aren’t reading them correctly and feel it’s better to be safe than sorry – even if that means leaving their suffering patients in the lurch. 

Either way, it’s a hell of a way to run a railroad and a lousy way to practice the healing arts.  Leaving so many people in agony is criminal.  For a doctor to do this, they might as well sell insurance for all the good they are doing their patients. What happened to the Hippocratic Oath?

I have to confess.  I am getting desperate.  With the level of pain and stress I am under, my health is breaking down. I can understand why some might consider suicide as a real option as an alternative pain solution. 

The CDC needs to consider how this will affect the aging population, for whom opiate medication may be the only path to a decent quality of life during their later years.  I mean, what are they afraid of? Lines of aging junkies sitting in the gutter with a needle in their arm? 

It is interesting to note that none of this is affecting the addict population, other than to increase the number of people seeking pain relief on the black market.  Addicts will always find a way.  Legitimate seniors with palliative and end-of-life pain concerns, and others with legitimate pain needs, have nowhere else to turn. 

Medicine is failing us. This is medicine by law enforcement. Scare the doctors and the problem will go away.  If the DEA is frightening doctors with the loss of their license, the CDC needs to step in and call off the dogs.

I just hope this communication to my pain doctor comes before I die from complications of intense pain.  What a way to go. Death by good intentions, but poor communication.

Who speaks for us, if not the doctor?

Michael Thompson lives in the Dallas, Texas area.

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.

Flu and NSAIDs Increase Heart Attack Risk

By Pat Anson, Editor

With the cold and flu season in full swing, many people take over-the-counter pain relievers like Advil and Aleve to ease their aches and pains, and to help them sleep.

What many don’t know is that they may be increasing their risk of a heart attack.

In a study of nearly 10,000 people hospitalized in Taiwan after a heart attack, researchers found that patients who took non-steroidal anti-inflammatory drugs (NSAIDs) during an acute respiratory infection tripled their risk of an acute myocardial infarction (heart attack).  The study was published in the Journal of Infectious Diseases.

Respiratory infections and NSAIDs were both already known to raise the risk of cardiovascular problems, but this was the first time they were studied together.  

"Physicians should be aware that the use of NSAIDs during an acute respiratory infection might further increase the risk of a heart attack," said lead author Cheng-Chung Fang, MD, of National Taiwan University Hospital.

“This approach should raise clinical concern because NSAIDs use during ARI (acute respiratory infection) episodes is highly common in real-world practice.”

Fang and his colleagues found that using NSAIDs while having a respiratory infection was associated with a 3.4-fold increased risk for a heart attack. The risk was 7.2 times higher when patients received NSAIDs intravenously in the hospital.

Another commonly used pain reliever, acetaminophen, which eases pain in a different way than NSAIDs do, was not evaluated in the study. But researchers say it may be a safer alternative, at least in terms of cardiac risk, for relief from cold and flu symptoms.

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are found in so many different over-the-counter products -- such as ibuprofen, Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

In 2015, the U.S. Food and Drug Administration ordered warning labels for all NSAIDs to be strengthened to indicate they increase the risk of a fatal heart attack or stroke. The revised warning does not apply to aspirin. The FDA said people who have a history of heart disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk.

European researchers released an even stronger warning last year, saying there was no solid evidence that NSAIDs are safe.

Exactly how the pain relievers damage the heart is unclear, but a recent study on animals at the University of California, Davis found that NSAIDs reduced the activity of cardiac cells and caused some cells to die.

We Need to Admit Opioid Medications Are Dangerous

By Fred Kaeser, Guest Columnist

If chronic pain patients want continued access to opioid medications, we're going to have to admit they can be dangerous

There, I said it.

This has been bothering me for some time now, the apparent inability of many opioid medication users to admit that opioids can be dangerous. Read through the comments here at PNN or any other chronic pain forum and you'll hear a continuous drumbeat from many that opioids are safe when used for chronic pain. No ifs, ands, or buts.

The truth is no one really knows how safe or unsafe long-term opioid use is. No one knows because those studies have never been done.

But what many of us chronic pain patients do know is that popping a 10 mg oxycodone or its equivalent will pretty much do the job for us for a few hours or more.

And for many of us, it will do the job better than any other complimentary or alternative pain modality you can throw at us.

Of course, there are those who will tell us that opioid medications are dangerous. If you happen to be one of the 2.2 million people suffering from opioid medication addiction (OMA) you know they're dangerous. If you're one of the 4 million or so parents whose son or daughter suffers from OMA, you know they're dangerous. And if you're one of the nearly 30,000 parents whose son or daughter died last year from an opioid medication interaction, you really know they're dangerous.

So, opioid medications are dangerous – to them. But what about us chronic pain patients? If you are genetically predisposed to addiction, opioid medication is potentially dangerous to you. But even if you're not predisposed, opioid addiction is still possible. If the addiction rate is just 1% (which some believe), that means for the 11 million Americans who use opioid medication daily, they're dangerous for 110,000 of us. And if you believe the addiction rate is 10%, they're dangerous for 1.1 million of us.

Ever experience opioid withdrawal? Some of us have. How did you like going through that? Many would admit that was pretty dangerous. And if we didn't think it was, we sure thought that it sucked. And how about opioid medication misuse? Misuse our medications and risk respiratory distress or some other negative consequence? It can all be pretty dangerous.

Why do we need to admit opioids are dangerous?

Because to the average Joe and Jane America, we’ll seem pretty stupid if we don't. Policy makers and most of America have bought into the idea that opioids (legal and otherwise) pose a huge problem. If we don't jump on that bandwagon and work together to see how this problem can be effectively handled, we're only going to be left further behind. That train left the station and it isn’t coming back.

Continue to resist admitting that opioid medications can be dangerous, and all those that believe they are will continue to turn a deaf ear when we say we need them for pain relief. We only sound like the addict who is equally convinced that they need their drugs.

We can no longer afford to be seen as part of the problem. It is time that we are seen as part of the solution. And that starts with an open and honest dialog about the dangers of opioids, along with a similar dialog as to how chronic pain sufferers gain a quality of life when we take our medications responsibly -- which is the case the vast majority of the time.

We can argue that chronic pain patients should continue to have access to opioid medication, while at the same time agreeing that they can be dangerous and have created a problem for many in our society.

We can continue to lobby and fight for our right to adequate pain relief, while at the same time lend our efforts in the fight to minimize and reduce the horrors of addiction and death.

By doing so we will enhance our plight in the eyes of those that do not know what it is like to suffer daily the burdens of debilitating chronic pain.

By doing so we will be seen as reasonable and responsible in wanting to thwart the opioid problem. And even though we suffer, we are willing to fight for the greater good.

Most of us are pretty good at standing up and saying we deserve the medications that serve us so well. We can still do that when we also admit that they can be very dangerous.

Fred Kaeser, Ed.D, is the former Director of Health for the NYC Public Schools. Fred suffers from osteoarthritis, stenosis, spondylosis and other chronic spinal problems. He taught at New York University and is the author of What Your Child Needs to Know About Sex (and When): A Straight Talking Guide for Parents.

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 represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Lyrica and Cymbalta Advised for Diabetic Neuropathy

By Pat Anson, Editor

New guidelines by the American Diabetes Association for the treatment of diabetic neuropathy strongly discourage the use of opioids to treat nerve pain, while recommending pregabalin (Lyrica) and duloxetine (Cymbalta).

Nearly 26 million people in the United States have diabetes and over half have some form of neuropathy, which often causes a painful stinging or burning sensation in the hands or feet.  Nerve pain is often the first symptom that prompts people to seek medical care before getting a diabetes diagnosis.

Researchers at the University of Michigan led a group of internationally recognized endocrinologists and neurologists, and teamed up with the American Diabetes Association (ADA) to craft a new position statement on the prevention, treatment and management of neuropathy. The ADA last released a statement on diabetic neuropathy in 2005.

"Our goal was to update the document so that it not only had the most up-to-date evidence, but also was easy to understand and relevant for primary care physicians," said lead author Rodica Pop-Busui, MD, a professor of internal medicine at Michigan Medicine Division of Metabolism, Endocrinology and Diabetes.

"Treatment of neuropathy pain is specifically relevant because, unfortunately, there has been much overprescribing of narcotics for neuropathic pain."

Although opioids like oxycodone and tramadol are effective in relieving nerve pain, they are not recommended by the ADA as a first, second or even a third-line treatment.

“Despite the demonstrated effectiveness of opioids in the treatment of neuropathic pain, there is a high risk of addiction, abuse, sedation, and other complications and psychosocial issues even with short-term opioid use. For these reasons, opioids are not recommended in the treatment of painful DSPN (distal symmetric polyneuropathy) before failure of other agents that do not have these associated concerns,” the guideline states.

Instead of opioids, the ADA recommends either pregabalin (Lyrica) or duloxetine (Cymbalta) as an initial treatment for neuropathic pain. Gabapentin (Neurontin) can also be considered.

PNN readers often complain of side effects from all three drugs – such as depression, fatigue, nausea, headache and weight gain -- yet the ADA statement only vaguely warns that their “adverse effects may be more severe in older patients.”

"Lyrica did help with my nerve pain but the side effects were intolerable and the withdrawal was absolute hell," said Laura.  "I gained 20 pounds in a month and was even more of a zombie than when I was on gabapentin. I had no personality, no interest in anything, and had completely lost motivation to do anything."

"I have been on Cymbalta a couple of years. It has helped overall with depression, anxiety and pain. I also can't miss a dose or try to quit cold turkey," wrote Rebecca Williams. "I become very dizzy, nauseated, night sweats, crazy dreams, electrical zaps in my head. I don't know how I would ever get off of it because the withdrawal symptoms are unbearable."

The ADA guidelines recommend that physicians try different therapies to prevent or slow the progression of diabetic neuropathy, most of which focus on controlling high blood sugar (glucose), which can cause irreversible damage to small nerve fibers. Insulin, regular exercise and a low-calorie, low-fat diet can help regulate glucose levels.

To see the ADA’s recommendations, click here.

Acupuncture Effective in Treating Pain and Depression

By Pat Anson, Editor

Acupuncture can boost the effectiveness of medical care and lessen the severity of chronic pain and depression, according to a new study led by British researchers.

In a meta-analysis (a study of studies) of 29 clinical trials involving nearly 18,000 patients with chronic neck, lower back, knee or headache pain, researchers found that acupuncture significantly reduced the severity of pain when combined with standard medical care such as anti-inflammatory drugs.

Acupuncture is an ancient Chinese form of treatment that involves the insertion of fine needles into acupuncture points on the body. About four million acupuncture sessions are provided each year in the UK, about half of them for pain relief. The evidence to support such treatment has been limited.

"There has been a question mark for many years over whether policy and decision makers should or should not provide wider access to acupuncture,” said Hugh MacPherson, PhD, a professor of acupuncture research at the University of York.

“Our aim was to bring together data from high quality clinical trials and provide a robust evidence base that will help reduce this uncertainty and support commissioners and health professionals in making informed decisions backed up with research."

The study, published in the National Institute for Health Research (NIHR) Journals Library, found that the addition of acupuncture -- compared to standard medical care alone -- significantly reduced the number of headaches and migraine attacks and reduced the severity of neck and lower back pain.  Acupuncture also reduced the pain and disability of osteoarthritis, which led to patients using less anti-inflammatory medication to control pain.

The research team also conducted a new clinical trial for depression, in which 755 patients were provided with acupuncture, counseling or antidepressants. They found that both acupuncture and counseling significantly reduced the severity of depression, and that the benefits were sustained up to 12 months after treatment.

"In the largest study of its kind, we have now provided a solid evidence base to show that not only can acupuncture and counseling bring patients out of an episode of depression, but it can keep the condition at bay for up to a year on average," said MacPherson, who added that antidepressants don’t work well for more than half of patients.

Researchers admit the benefits of acupuncture are partially associated with a placebo effect, which has contributed to uncertainty about it's clinical effectiveness. However, when compared with sham acupuncture – in which fake needles are used or inserted in the wrong locations – they say “real” acupuncture provides substantially more pain relief.

“Our new data provides a significant step forward in treating chronic pain and managing depression, because patients and health professionals can now make decisions on acupuncture with more confidence. Not only is it more cost effective, but it reduces pain levels and improves mood levels, which could reduce over reliance on drugs that can sometimes result in unwanted side effects," MacPherson said.

Acupuncture is one of the most widely practiced forms of alternative medicine. As many as 3 million Americans receive acupuncture treatments, most often for relief of chronic pain. While there is little consensus in the medical community about acupuncture’s value, a large study in the Archives of Internal Medicine found that  “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option.”