Opioid Limits: Means, Medians or Madness?

By Roger Chriss, Columnist

CVS recently announced it would impose a 7-day limit on opioid prescriptions for short-term acute pain for customers in its pharmacy benefit management program.  A pharmaceutical industry trade group also supports a 7-day limit and so does the U.S. Pain Foundation, a patient advocacy group.

Maine, New Jersey, Massachusetts and other states are also limiting prescriptions to a week or less, justifying the time frame by saying that’s what patients need on average.

But this represents a misunderstanding of how statistics work and ignores emerging research about opioid analgesia in the world of acute pain care.

In statistics, we have three values of fundamental importance: the mean, median, and variance.

The mean, also known as the “arithmetic mean,” is the sum of a collection of numbers divided by the number of numbers in the collection. The average height or weight of a group of people is the mean.

The median is the “middle value” of a data set that is ordered from lowest to highest. The mean is found in “median income” or “median price of a new home.” Importantly, the mean and median are not necessarily the same. In the set of numbers 2, 3, 3, 5, 7, 17 and 313, the median value is 5, but the mean value is 50.

The variance is the tendency of a set of numbers to cluster around the mean, or how spread out the numbers are. We know from experience that the height of adults is closely clustered around average height: Most people are over five feet tall and under seven feet tall. No one is 2 inches or 20 feet tall. But variance can also be significant, as is the case with annual income, home prices or family size.

The significance of these three values cannot be understated. In his essay “The Mean Isn’t the Message,” biologist Stephan J. Gould explains that a “median mortality of eight months” does not mean that a person will probably be dead in eight months. Some people, including Gould himself, live many times more than the median survival time for a disease. 

So when talking about opioid analgesia for acute pain, we cannot rely on just an “average” value. Physicians know this, but legislators, corporations and even some patient advocates do not seem to.

JAMA Surgery recently reported on the post-surgical acute pain needs of over 200,000 patients who had one of eight common surgical procedures. The results showed median values from 4 days for an appendectomy or gallbladder surgery to 7 days for a discectomy.  

The authors then used these values and the variance to calculate the range of time a patient would typically need opioids for acute pain after surgery:

• 4 to 9 days for general surgery procedures
• 4 to 13 days for women's health procedures
• 6 to 15 days for musculoskeletal procedures

In other words, there is substantial variance, with the optimal length extending to as much as two weeks. And there is no way to know ahead of time where in this range an individual will fall.

To address this uncertainty, the Opioid Prescribing Recommendations for Surgery were developed at the University of Michigan. They list the recommended numbers of tablets of hydrocodone, codeine, tramadol, or oxycodone for a range of common surgical procedures, including laparoscopic cholecystectomy, open colectomy, and several types of biopsy.

This resource gives amounts that “represent the actual maximum opioid use reported by three-quarters of actual surgery patients.” Those amounts range from 10 to 40 pills, depending on the procedure, noting that “prescribers are encouraged to use their best judgment.”

The Opioid Prescribing Recommendations for Surgery also advise recovering unused pills to reduce the risk of diversion, which is a much more sensible policy than forcing people recovering from trauma or surgery to seek refills if they happen not to fit a mandated average.

In sum, the medical profession is offering evidence-based recommendations for pain management that include not just a simplistic mean, but the real-world variance found in individuals. This approach is likely to provide better results than blanket policies geared toward a statistical mean that does not capture vital features of medical care.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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.

Why Human Suffering Should Bother You

By Margaret Aranda, MD, Columnist

Patients go to doctors when they have pain and doctors can give them opioid medication to relieve that pain. That should not bother you, because it is a decision made between the physician and the patient.

No doctor has the right to strip a patient of dignity by minimizing or downplaying their pain. We can't become indifferent to the denial of pain, because pain is real. Pain hurts.

A recent column in The Conversation by Dr. Andrew Kolodny bothers me because of two sentences:

"They (opioids) are also helpful when used for a couple of days after major surgery or a serious accident. Unfortunately, the bulk of the opioid prescriptions in the U.S. are for common conditions, like back pain," wrote Kolodny, who is a psychiatrist, not a pain management doctor.

Let’s look at the different ways that Dr. Kolodny is minimizing pain:

Postoperative Pain: A large study recently found that long-term opioid use after surgery is rare. Yet some patients are now being denied opioids after major surgery because of fears they might become addicted. Patients should ask questions about how their postop pain will be treated before surgery and get another surgeon if no opioids are to be offered. Patients do not have to allow a surgeon to minimize their pain.

Trauma:  Serious accidents cause severe trauma. Severe trauma can take months, years or decades to alleviate, leaving patients with chronic pain through no fault of their own. Many are burned, disfigured, scarred, disabled, have a pain syndrome, use a wheelchair, and go on disability or Medicare. 

We cannot allow ourselves to minimize any degree of pain that leads to suffering, less zest for living, and lower quality of life.

Back Pain: Millions of people have low back pain and the added mental health stress that often comes with it, which costs the U.S. economy $100-200 billion in lost workdays and productivity annually. Don't minimize their pain, either!

Treating Pain:  No doctor who witnesses a patient suffering in an emergency room, operating room or intensive care unit should minimize their pain. I've worked in all three as a board certified anesthesiologist and intensive care unit doctor, and am a witness to how an Ivy League university, private clinic, free clinic, county hospital, women's hospital, and Veterans Administration hospitals treat severe pain that may never, ever get better. I'm also a witness as a rebel patient who was offered acetaminophen and ibuprofen for my postop pain.

Physician judgment: Many patients with chronic pain are disabled and legally protected from discrimination. They have failed other therapies and deserve opioid medication for quality of life. They are not bad people, and they have not done anything wrong. Nevertheless, they are often treated like "today's lepers," as Dr. Thomas Kline says. So don't minimize their pain.

Patient Perspective: While on opioids, many chronic pain patients can get out of bed, work a job and keep their families together. They aren't addicts, do not sell their pills, steal money from others to get more, are not estranged from their families for a “drug problem,” and have never had naloxone used on them.

If they are lucky enough to still get an opioid prescription, many are being treated like criminals with rigors that do not stand on evidence-based medicine. They are forced to sign pain contracts, undergo drug tests, and then deal with pharmacy restrictions. Even with pills in hand, it is often not enough. There is an epidemic of undertreated chronic pain, so don't minimize the patient.

Patient Outcome: Unilateral withdrawal or sudden tapering of opioid therapy leads to patient suffering, sleep loss and decreased quality of life. A patient can become bedridden, depressed, and some have committed suicide! It all starts with non-validation of pain.

The Doctor's Oath

No doctor has a right to label, stigmatize, minimize or abandon a patient, much less a patient in pain. To stay clear of this, every medical student is taught to preserve patient dignity and autonomy. Nevertheless, patients are being withdrawn from opioid therapy all over America today, and it is being done by doctors who minimize pain, break the physician-patient bond, and dishonor the Hippocratic Oath.

We've known for over 150 years that doctors commit suicide twice as often as other professions. I think the current situation truly bothers most compassionate doctors, who will be struggling even more in the years to come with physician burnout syndrome. We could see even more suicides by medical students and physicians. 

Doctors are supposed to save lives, and it is just as important to save quality of life. Without quality of life, it is entirely human to have moments when death seems to be the only option out of a life of suffering. Doctors need to keep patients away from having suicidal thoughts, especially if their illness is something that modern medicine can take care of and is severely undertreated, like pain.

It is important to the public in general, and to patients who are disabled in particular, that everyone understands that there are doctors who work night and day for patients who are in pain. We are passionate about it because doctors are healers and no one is ever going to change the meaning of being a real doctor.

I was reminded of this recently when I saw the revised version of the Hippocratic Oath by the World Medical Association. Two important sentences depict how doctors should be responding to pain and their patients:

“I WILL RESPECT the autonomy and dignity of my patient."

"I WILL NOT USE my medical knowledge to violate human rights and civil liberties, even under threat."

When we minimize pain, we minimize the patient. When we minimize the patient, the patient dies.

So go ahead and let human suffering bother you. It proves that you still have empathy and compassion. 

Dr. Margaret Aranda is a Stanford and Keck USC alumni in anesthesiology and critical care. She has dysautonomia and postural orthostatic tachycardia syndrome (POTS) after a car accident left her with traumatic brain injuries that changed her path in life to patient advocacy.

Margaret is a board member of the Invisible Disabilities Association. She has authored six books, the most recent is The Rebel Patient: Fight for Your Diagnosis. You can follow Margaret’s expert social media advice on Twitter, Google +, Blogspot, Wordpress. and LinkedIn.

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

A Promising Solution to Lower Back Pain

By A. Rahman Ford, Columnist

As many of us can attest to, lower back pain (LBP) is a debilitating and painful medical condition that severely impacts quality of life.  An analysis of the Global Burden of Disease in 2010 showed that LBP ranked as the greatest contributor to disability out of nearly 300 conditions studied. 

Lower back pain tends to peak in older age groups; thus, regions with higher life expectancies are disproportionately impacted.  The number of people with LBP is projected to increase in the coming decades, especially in low- and middle-income countries.  About 149 million work days are lost every year in the U.S. because of LBP, at an estimated cost of $100-200 billion.  

Of course, the costs to the patient – both financial and emotional – can never be adequately quantified.

Tough Questions, Few Answers

Although the causes of LBP generally are multifarious, the National Institutes of Health maintains that the majority of cases are mechanical in nature.   The gradual degeneration of the spine as a result of normal wear and tear – referred to as spondylosis – can result in a myriad of painful conditions that range from simple sprains, to herniated or ruptured discs, to injuries caused by trauma. 

While the causes of lower back pain are rarely addressed, analgesic medications are routinely prescribed to treat its symptoms.  Commonly prescribed medications include opioids, NSAIDS, anticonvulsants, antidepressants, counter-irritants and epidural steroid injections.

However, these analgesic treatments have shortcomings: potentially dangerous side-effects, adverse drug interactions, addiction, organ damage or only temporary relief.  Other treatment options include physical therapy, transcutaneous electrical nerve stimulation (TENS), acupuncture and in extreme cases, surgery. 

Sadly, neither the conservative management nor the more invasive surgical options consistently yield satisfactory results, because they fail to address the underlying disease processes.  In fact, some treatments may actually lead to a worsening of the condition in the long term.  Undoubtedly, new approaches are needed to solve the problem.

Research Supports Stem Cells for LBP

Many cases of lower back pain involve structural damage to the intervertebral discs, either by way of a herniated disc or degenerative disc disease (DDD).  This condition is quite prevalent among older adults, with one study finding that 95% of older Americans exhibiting some degree of disc degeneration. 

In the search for treatments beyond analgesics and surgery, several researchers have demonstrated the effectiveness of stem cell therapy in treating disc injuries in both humans and animals. 

Leung et al. (2006) and Drazin et al. (2012) noted the potential for mesenchymal stem cells (MSC) to treat intravertebral disc degeneration in laboratory animals.  Orozco et al. (2011) used autologous bone marrow-derived MSCs to treat 10 patients with lumbar disc degeneration, who exhibited rapid improvement in pain and disability. 

Similarly, Pettine et al. (2015) reported significantly reduced pain scores in 26 patients who received autologous bone marrow-derived stem cells. 

Coming to a Clinic Near You?

Just this year, Centeno et al. successfully used an injection of autologous bone marrow derived MSCs to treat DDD in 33 patients with lower back pain.  The authors found “no safety issues, substantially reduced pain, increased function and reduced disc bulge size in most patients.”

That treatment utilized stem cell technology created by BioRestorative Therapies, which uses autologous bone marrow-derived MSCs to treat chronic lumbar disc disease.  According to the company’s website, “not only could this program potentially eliminate surgery in many cases, but it could also provide substantially more effective treatment than current non-invasive therapies with a design to be curative.”  The company has been cleared by the FDA for Phase 2 clinical trials to treat lower back pain due to DDD.

DiscGenics, a biotech company based in Utah, has also received FDA approval for a study of stem cell therapy to treat patients with intervertebral disc disease. DiscGenics’ approach is different, because it uses patented technology to derive its proprietary “discogenic cells” directly from adult human disc tissue.

“We believe it has the potential to offer pain relief and restored function to millions of patients suffering from the debilitating effects of lower back pain,” DiscGenics CEO Flagg Flanagan told The Salt Lake Tribune. “Receiving the go-ahead from the agency to begin in-human trials is a critical step forward for our clinical program.”

DiscGenics plans to begin enrolling 60 patients in the study before the end of the year.  

Although both BioRestorative and DiscGenics have therapies that look promising, it will be some time – likely years – before either treatment is publicly available. But these studies could be a major step forward in finding an actual cure for back pain, not just another treatment that masks the pain.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

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.

Insurers Promise More Cuts in Rx Opioids

By Pat Anson, Editor

Less than two weeks before its final report is due, President Trump’s opioid commission held its fourth and final public meeting Friday – hearing testimony from top government officials and insurance industry executives about the nation’s worsening overdose crisis.

“Insurance companies are going to be a very, very important part of whether we will be able to stem the tide here or whether we’re not,” said commission chairman Gov. Chris Christie of New Jersey.

It was clear from their testimony that many insurers are planning to tighten access to prescription opioids even more than they already have.

Aetna’s chief medical officer told the commission the insurance giant was planning to reduce “inappropriate opioid prescribing” to its members by 50 percent within the next five years.  He did not explain what would be considered inappropriate.

Aetna has already sent warning letters to hundreds of physicians and dentists identified as “super-prescribers,” urging them to reduce the number of opioid prescriptions they write.

“We’re now re-running our analysis and planning more aggressive interventions for those providers who haven’t improved their opioid prescribing habits over the past several months,” said Harold Paz, MD.  

The chief medical officer of Cigna said his company was close to achieving a 25 percent reduction in coverage of opioid prescriptions, a priority it set last year.

“That’s only the first of our goals,” said Alan Muney, MD.

Insurer Harvard Pilgrim said its coverage of opioid prescriptions has declined by over 20 percent since 2014.

“That’s not enough.  This feels like a balloon where you tap on one end and it comes out somewhere else. So it doesn’t mean we’re even close to solving this,” said Michael Sherman, MD, chief medical officer of Harvard Pilgrim.

Insurers clearly have the ear of the federal government when it comes to opioids. As PNN has reported, an obscure federal advisory group composed of insurers, law enforcement, and federal and state regulators has discussed eliminating opioid prescriptions for acute pain, as well as paying doctors not to prescribe opioids.

The Healthcare Fraud Prevention Partnership also wants access to the “personally identifiable and protected health information” of 57 million Medicare beneficiaries to see if they are abusing opioids.

Reducing Opioids a ‘Win-Win’

Labor Secretary Alexander Acosta said reducing opioid prescriptions was important to get unemployed Americans back into the workforce. He cited a recent study that found that about a third of unemployed men aged 25 to 54 were using prescription painkillers.   

“Reducing the amount of opioids is a win-win across the board. It’s a win for the individual who doesn’t want to get hooked,” Acosta said. “It’s a win for the insurance companies who don’t want to be paying for medicines that people don’t need. And it’s a win for the American workforce, because if we can get people back to work and paying taxes and participating fully, that’s a win for them and it’s a win for the country.”

Acosta cited no studies that might indicate how many Americans currently taking opioids would become unemployed or disabled if their pain medication was reduced or taken away. 

No pain patients, patient advocates or experts in pain management were asked to appear before the commission. No one from the pain community has testified during any of the commission’s public meetings, although thousands have submitted written comments.

An interim report released by the opioid commission in July focused on expanding access to addiction treatment and developing new ways of treating pain without opioids. Since then, the commission has increasingly focused on limiting opioid prescriptions. The final report from the commission is expected November 1.

The interim report also strongly urged President Trump to declare a national emergency to speed up efforts to combat the overdose crisis, something he has yet to do.  “We’re going to be doing it in the next week,” Trump told reporters on Monday.  However, there appears to be little consensus in the administration about what actions to take after an emergency is declared or how to pay for them.

"Everyone wants opioids to be a priority, but there's a lot of resistance to calling it an emergency," a senior administration official told Politico.

Nursing Textbook Slammed for Racist Content on Pain

By Pat Anson, Editor

Blacks believe suffering and pain are inevitable. Hispanics believe pain is a form of punishment. Muslims consider pain a test of faith. Jews are vocal and demanding about pain care.

Those are some of the startling claims being made in "Nursing: A Concept-Based Approach to Learning," a nursing textbook that has a section that looks at ethnic and cultural differences in how people respond to pain.

The book advises nursing students that a patient’s culture and religion play a “critical role” in how a patient responds to acute or chronic pain, and that “nurses must approach each client with cultural competence.”

Fair enough. But then the book makes sweeping generalizations about various ethnic groups that some consider offensive and racist.

“Clients from Asian cultures often value stoicism as a response to pain. A client who complains openly about pain is thought to have poor social skills,” the book declares.

“Native Americans may prefer to receive medications that have been blessed by a tribal shaman…. They may pick a sacred number when asked to rate pain on a numerical scale.”

The textbook has been used by nursing students for years, but the section on diversity and culture drew little attention until a page from the book started circulating on social media this week.

“This is an excellent example of how not to be even remotely culturally sensitive. These assumptions are not evidence-based, they encourage nurses to ignore what a patient is actually saying,” said Onyx Moore, who posted the page on Facebook. “If a patient tells you their pain level, believe them -- because *they* are the expert on their body."

“I'm so disgusted. In 2017 how is this being published?” asked one poster. “Why isn't the protocol basic compassion instead of that ignorant nonsense?”

"I’ve seen so many examples like this in my nursing textbooks. It’s infuriating," wrote another Facebook poster.

“This is horrifyingly wrong,” said another.

In response to the uproar on social media, the book’s publisher apologized and said it would drop the offending section from the textbook.

“While differences in cultural attitudes towards pain are an important topic in medical programs, we presented this information in an inappropriate manner. We apologize for the offense this has caused and we have removed the material in question from current versions of the book, electronic versions of the book and future editions of this text,” Scott Overland, Pearson Publishing’s communications director told Mic.com.

“In addition, we now are actively reviewing all of our nursing curriculum products to identify and remove any remaining instances of this inappropriate content that might appear in other titles.”

Now in its second edition, “Nursing: A Concept-Based Approach to Learning” is still available for sale on Amazon, where a new hardcover can be bought for $235. First published in 2014, many of the early reviews of the book are positive, with some nursing students saying it was “indispensable” and a “life safer.”

The more recent reviews -- apparently in response to the uproar on social media -- are scathing.

“This book should cease to be printed. The fact that this is taught in schools makes me quite literally sick,” one reviewer said.

“This book is racist and if you apply it's concepts you will hurt your patients and possibly get in some uncomfortable situations or even litigation,” said another.

“If this kind of racist dreck can pass unnoticed by the authors AND editors of this book, it cannot be trusted. And they cannot be trusted. Unbelievable,” wrote another reviewer.

Pearson is the world’s biggest publisher of educational textbooks. Today the company put a video on its YouTube page in which Tom Bozik, president of Pearson’s global product development, made another apology and said the book doesn't represent the company's values.

Drug Overdose Rates Rise in Rural Areas

By Pat Anson, Editor

Rates of drug overdose deaths in rural areas of the United States now exceed those in urban areas, according to a new report by the Centers for Disease Control and Prevention.

CDC researchers say the overdose rate in non-metropolitan (rural) areas was 17 deaths per 100,000 people in 2015, which was slightly higher than urban areas (16.2 deaths). Both rates are substantially higher than they were a generation ago. About 52,000 Americans died of drug overdoses in 2015.

“The drug overdose death rate in rural areas is higher than in urban areas,” said CDC Director Brenda Fitzgerald, MD. “We need to understand why this is happening so that our work with states and communities can help stop illicit drug use and overdose deaths in America.”

In 2015, both urban and rural areas experienced significant increases in the percentage of people aged 26 and older who reported illicit drug use in the past month.

One of the few bright spots in the CDC report is that use of illicit drugs by adolescents (aged 12-17 years) has declined for the last ten years.

The report did not go into detail on what drugs were being abused, although it acknowledges the declining role of prescription opioids in the overdose crisis.

“Although prescription drugs were primarily responsible for the rapid expansion of this large and growing public health crisis, illicit drugs (heroin, illicit fentanyl, cocaine, and methamphetamines) now are contributing substantially to the problem,” the report found.

“Recent studies suggest that a leveling off and decline has occurred in opioid prescribing rates since 2012 and in high-dose prescribing rates since 2009.”

Curiously, while those studies have documented the increased role of heroin, illicit fentanyl and other illegal opioids in the overdose crisis, the federal government’s public awareness campaigns remain focused on prescription opioids.  

Heroin and fentanyl are barely even mentioned in the Department of Health and Human Services’ “5-Point Strategy to Combat the Opioid Crisis.” The strategy focuses instead on “advancing better practices for pain management,” and increasing access to addiction treatment and overdose prevention drugs.

The CDC also recently launched an advertising campaign using billboards and videos that completely ignore the scourge of heroin and fentanyl.  The CDC explained the omission by saying it wanted to focus on prescription opioids and avoid “diluting the campaign messaging.”

“Prescription opioids can be addictive and dangerous,” a woman says in one CDC ad.

“One prescription can be all it takes to lose everything,” a man says in another ad.

Five public health experts interviewed by Pacific Standard questioned whether the CDC campaign will be effective, because the ads don't empower people or give them an alternative to prescription opioids.

"The campaign isn't going to make a damn bit of difference," said Bill DeJong, a professor of community health sciences at Boston University.

The Secret Role of Insurers in Medicare Opioid Policy

By Pat Anson, Editor

This month marks the one year anniversary of a closed door meeting between law enforcement agencies, federal and state regulators, and health insurance companies in a Baltimore suburb – a “special session” of an obscure advisory group to the U.S. Justice Department and the Department of Health and Human Services.

Although the mission of the Healthcare Fraud Prevention Partnership – HFPP for short -- is to prevent healthcare fraud, the October 20, 2016 meeting went much further. It gave the insurance industry – so-called “Partner Champions” -- a direct role in drafting recommendations that could decide how millions of pain patients will be treated by their doctors and what opioid medications will be prescribed to them, if any.

Major insurers like Aetna, Anthem, Cigna, Humana, Blue Cross Blue Shield and Kaiser Permanente were invited to attend, but no other stakeholders in healthcare, such as physicians, pharmacists, hospitals or patients, were asked to appear or share their insights. Few details about the meeting were made public, until now.

Pain News Network has obtained documents through the Freedom of Information Act (FOIA) that shed some light on how the meeting was organized and what was discussed, but we were denied access to a list of individuals that attended, who they represented, or any recordings of what they said.

“The nature of some of the information provided during the Special Session on opioids would be of the sort that could have a negative impact on the competitive posture or business interests of a company if made public,” Jay Olin, Director of FOIA Analysis for the Centers for Medicare and Medicaid Services (CMS), wrote in a letter to PNN.

CMS COMMAND CENTER IN WOODLAWN, MD

“The release of this sensitive information could put the company at significant financial risk if interested parties use this information to develop and execute schemes and individuals and organizations use this information to game the system and reap financial or other benefit.”

Olin also said the HFPP is not a federal advisory committee and therefore not subject to federal open meeting laws, even though the October 20 meeting was called by CMS, organized by CMS, funded by CMS, and held on federal property at the CMS Command Center in Woodlawn, Maryland.

“Furthermore, most (HFPP) partners are from the private sector and private industry is not subject to FOIA, nor is CMS authorized to release such information,” Olin wrote.

PNN is appealing that decision.

‘Government-authorized use only’

CMS may be trying to distance itself from the HFPP, but it’s clear they work closely together in their unusual “public-private partnership.”

A CMS website hosts a portal for HFPP members to sign-in that plainly states “this system is provided for Government-authorized use only.” The website also goes into detail on how to become an HFPP partner, the benefits of membership and provides an extensive list of partners that includes 45 different insurance companies.

According to a recent report from the General Accounting Office (GAO), CMS has spent over $30 million funding the HFPP since 2012, the year the partnership was created by the Obama administration to help the federal government detect and prevent healthcare fraud. A side benefit for insurers is that it helps them lower the cost of healthcare coverage. A CMS flyer plainly states that one of the reasons the HFPP exists is to help payers “identify potential savings.”       

The goals and activities of the partnership are important to understand because CMS contracts with dozens of insurers to provide Medicare coverage to about 57 million elderly and disabled Americans, at an annual cost of nearly $700 billion. And if the insurance industry is making healthcare decisions while being subsidized with billions of taxpayer dollars, Americans have a right to know what’s going on.

Yet CMS won’t even say who attended that October 20 meeting.

“A total of 58 participants across 26 federal, state, public and private organizations, including CMS, attended the event,” is all that an executive summary of the meeting says about the attendees.

The first half of the daylong meeting wasn’t even about opioids. It focused on the HFPP’s mission: combating fraud. According to the executive summary, a CMS technical advisor briefed attendees about common fraud schemes in the addiction treatment and drug testing industries, such as “substance abuse facilities that may be exposing their patients to physical or other harm” and insurance claims from treatment facilities “for services not rendered and unnecessary service, including lab claims.”

Another fraud scheme flagged by CMS was “physicians who appear to be referring Marketplace (Medicare/Medicaid) members, as well as other individuals who may be paid by substance abuse facilities to sign people up for Marketplace coverage.”

After a break for lunch, the discussion veered away from fraud prevention and into treatment decisions normally left between a patient and their doctor. A CMS official “emphasized the need to look at improving the quality of care” and identified several priority areas, including “best practices for acute and chronic pain.”

“Eliminate or restrict opioid prescribing for acute conditions,” was one of the many strategies discussed. So was the concept of “pay for performance,” in which doctors would receive payments from insurers “for following guidelines or quality practices, not for prescribing opiates.”

“Higher copay for opioid prescriptions” was another recommendation, as was “step therapy and dosage control.”

"Media outreach" and “social media and digital advertising tools” were suggested as ways to promote patient and provider compliance through “social normalizing.”

It is not clear from the documents provided to PNN if these were strategies advocated by insurers, law enforcement or CMS.

‘Serious Conflict of Interest’ for Insurers

Attendees were told the ultimate goal of the meeting was “to produce an HFPP-branded White Paper that identifies best practices payers can take to effectively address and minimize current and future opioid abuse.”

In other words, the meeting was not just about fraud prevention. The insurance industry was being asked to help design federal policy on opioid prescribing and “encourage practices that connect patients to the level of care best suited to their needs…. while avoiding unnecessary services or opioid prescriptions.”

“It is very disturbing to see CMS working with insurance companies to reduce the amount of opioids prescribed without physician and organized medicine's input,” said Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine (AAPM). 

“It is a serious conflict of interest to have insurance companies determine what medications are appropriate and how much to use.”

Webster was also alarmed by some of the strategies discussed at the October 20 meeting.  

“The proposal that insurance might eliminate opioids for acute pain would leave many patients without any effective treatment. That is not helpful and will produce a huge backlash,” he said.

“To encourage CMS to reward doctors to not prescribe opioids is a very ominous trend, knowing that untreated pain can have lethal effects on the body,” said Ingrid Hollis, a patient advocate and mother of a chronic pain sufferer. “To perpetuate these myths about reining in the addiction crisis, when in fact it is looking more and more like cost saving measures, is a conflict of interest for sure.

“I also find it disturbing that a private group with so much influence on insurance would not disclose to you who was in attendance at their meetings. Because they are influencing public programs and healthcare funded by taxpayers, they need to disclose who they are.”

When asked why the October 20 meeting was closed to the public, a CMS spokesman said "all HFPP meetings are limited to members of the Partnership, as they deal with sensitive issues relating to fraud, waste and abuse in the healthcare sector."

Payer ‘Partner Champions’

The HFPP white paper was released in January on the CMS website. The 62-page report -- Healthcare Payer Strategies to Reduce the Harms of Opioids -- begins by praising the “Partner Champions” who helped draft it. 

Among the payers listed as “champions” were Aetna, Anthem, Blue Cross Blue Shield, Cigna, Centene, Highmark, Horizon, Humana, and Kaiser Permanente.

“To overcome the problems of prescription opioid misuse, it is also vital to understand that provider prescribing practices and patient drug seeking behavior can exacerbate the development and persistence of OUD (opioid use disorder),” the white paper warns.

“Providers may write prescriptions without assessing their patient’s risk for misuse, prescribe opioid analgesics for minor pain, prescribe a greater medication quantity or dose than warranted by the patient’s medical indication, or provide opioids fraudulently with the knowledge they are likely to be misused. Patients may exaggerate or falsify symptoms to obtain opioid prescriptions, seek prescriptions from multiple physicians, forge prescriptions, or obtain prescriptions for resale on the black market.”

The white paper goes on to endorse the CDC’s opioid prescribing guideline, and recommends that over-the-counter pain relievers such as aspirin, acetaminophen and ibuprofen be used as alternatives to opioids, as well as non-drug therapies such as cognitive behavioral therapy, chiropractic care and TENS nerve stimulation units. Few of these treatments are covered by insurance.

The white paper also encourages pharmacists to “deny payments for (opioid) prescriptions that do not conform to general prescribing practices” and to profile doctors and patients to identify “problematic actors and schemes.”

Patients could be profiled in one of three ways, according to the HFPP:

1. Stewards (those who follow guidelines)
2. Stockers (those who hoard medication)
3. Demanders (those who ask for medication)

The white paper does not discuss fraud in the addiction treatment industry, the initial focus of the October 20 meeting. Also unmentioned is a recent HFPP policy decision that allows insurers to share information about Medicare beneficiaries.

Individual patient data on 57 million Americans is now being pooled, studied and analyzed by the insurance industry, something that payers were previously reluctant to do.

“Several HFPP participants we spoke with indicated their support for the new strategy and willingness to provide beneficiaries’ personally identifiable information and protected health information for more in-depth HFPP studies,” the GAO report says.

“Several HFPP participants we spoke with indicated their support for the new strategy and willingness to provide beneficiaries’ personally identifiable information and protected health information for more in-depth HFPP studies.”

— GAO Report

Is the HFPP overstepping its authority? Do insurers have any business sharing and analyzing the personal health information of millions of Americans? No one at HFPP would comment. CMS referred us to this statement in the white paper:

“Payers can help to combat the opioid crisis by identifying and sharing strategies, such as reimbursement and coverage policies, conditions for provider plan participation, and dissemination of information to a variety of audiences, to address the large-ranging issues that lead to fraud, waste, and abuse in the healthcare system. Such interventions are particularly suited to payers due to their relationships with providers of healthcare services, pharmacies, insured patients, employers, and law enforcement (in cases where potential fraud is identified). Payers collect and administer a large amount of healthcare information that can be used to identify and intervene on behalf of patients at risk of opioid-related harm, as well as to target fraud, waste, and abuse in opioid prescribing.”

CMS announced plans to align its Medicare Advantage and Part D prescription drug plans with the CDC guideline soon after receiving the HFPP white paper. But some of the more extreme strategies discussed by the HFPP were not adopted. CMS won’t be paying doctors to follow the guideline or be eliminating opioids as a treatment for short term, acute pain.

But the agency is moving ahead with plans for a new monitoring system to identify opioid “overutilizers” -- physicians who prescribe high doses, patients who get them, and pharmacies that fill their prescriptions. Payers are authorized to drop suspicious pharmacies, doctors and patients from Medicare coverage and their insurance networks.

How many overutilizers are there? At last count, there were 15,651 Medicare beneficiaries getting multiple high dose opioid prescriptions. That may sound like a lot, but it amounts to only 0.04% of the 41.8 million patients enrolled in Medicare Part D plans.

Why are insurers targeting Medicare beneficiaries when only a tiny percentage may be abusing prescription opioids? Dr. Webster suspects the real motive is money.

“Clearly the insurance companies are benefiting from tunnel vision and a laser focus on Pharma companies and doctors,” says Webster. “There is a vast under appreciation that commercial insurers are also driven by the bottom line.  This is why they should not be making medical decisions without input from pain physicians and organized medicine.”

What is Opioid Use Disorder?

By Rochelle Odell, Columnist

You’ve probably heard or seen the phrase “Opioid Use Disorder.”  It’s a broad term currently being used to describe not only opioid addiction, but patterns of behavior that might be a sign of addiction or could lead to it.

If that sounds like they’re putting the cart before the horse, it’s because they are.

In order to understand Opioid Use Disorder, one must understand the government's stance on opioids. The National Institute on Drug Abuse – which is part of the National Institutes of Health (NIH) – lays it out in a recently revised statement on the opioid crisis:

“Every day, more than 90 Americans die after overdosing on opioids. The misuse of and addiction to opioids--including prescription pain relievers, heroin and synthetic opioids such as fentanyl--is a serious national crisis that affects public health as well as social and economic welfare."

Notice how they lump prescription pain relievers in with heroin and illicit fentanyl?  The more I research, the more I find this common thread of illogical thinking. The government consistently lumps pain medication in with illicit drugs.

Here’s another example from the NIH: 

“In 2015, more than 33,000 Americans died as a result of an opioid overdose, including prescription opioids, heroin, and illicitly manufactured fentanyl, a powerful synthetic opioid.

That same year, an estimated 2 million people in the United States suffered from substance use disorders related to prescription opioid pain relievers, and 591,000 suffered from a heroin use disorder.”

Substance use disorders “related” to pain relievers? Heroin use disorder? That got me wondering how many drug “disorders” there are.

According to the Substance Abuse and Mental Health Services Administration (SAMSHA), there are six major substance use disorders. Nearly 93,000,000 Americans have a substance use disorder of some kind:

1) Alcohol Use Disorder (AUD): About 17 million Americans have AUD. According to the CDC, alcohol causes 88,000 deaths a year. 

2) Tobacco Use Disorder: Nearly 67 million Americans use tobacco. According to the CDC, cigarette smoking causes more than 480,000 deaths a year.

3) Cannabis Use Disorder: Over 4 million Americans meet the criteria for a substance use disorder based on their marijuana use. No estimate is provided on the number of deaths caused by marijuana, if any.

4) Stimulant Use Disorder:  This covers a wide range of stimulant drugs that are sometimes used to treat obesity, attention deficit hyperactivity and depression. The most commonly abused stimulants are amphetamine, methamphetamine and cocaine. Nearly 2 million Americans have a stimulant use disorder of some kind.

5) Hallucinogen Use Disorder: This covers drugs such as LSD, peyote and other hallucinogens. About 246,000 Americans have a hallucinogen use disorder.

6) Opioid Use Disorder: Again, this covers both illicit opioids and prescription opioids. In 2014, an estimated 1.9 million Americans had an opioid use disorder related to prescription pain relievers and 586,000 had a heroin use disorder (notice the SAMSHA numbers are somewhat different from what the NIH tells us).

But what exactly is Opioid Use Disorder?  Does it mean 2.5 million Americans are addicted to opioids?

No.

The diagnostic codes used to classify mental health disorders were revised in 2013 to cover a whole range of psychiatric symptoms and treatments. Two disorders – “Opioid Dependence” and “Opioid Abuse” -- were combined into one to give us “Opioid Use Disorder.” Few recognized at the time the significance of that change, it's impact on pain patients, or how it would be used to inflate the number of Americans needing addiction treatment.

Elizabeth Hartley, PhD, does a good job explaining what Opioid Use Disorder is in an article for verywell.

Hartley wrote that Opioid Use Disorder can be applied to anyone who uses opioid drugs (legal or illegal) and has at least two of the following symptoms in a 12 month period:

• Taking more opioids than intended
• Wanting or trying to control opioid use without success
• Spending a lot of time obtaining, taking or recovering from the effects of opioids
• Craving opioids
• Failing to carry out important roles at home, work or school because of opioid use
• Continuing to use opioids despite relationship or social problems
• Giving up or reducing other activities because of opioid use
• Using opioids even when it is unsafe
• Knowing that opioids are causing a physical or psychological problem, but using them  anyway
• Tolerance for opioids.
• Withdrawal symptoms when opioids are not taken.

The last two criteria will apply to almost every chronic pain patient on a prescription opioid regimen. So might some of the others. Most of us develop a tolerance for opioids, and if they are stopped or greatly reduced, we will experience withdrawal symptoms.  We simply cannot win for losing. 

If you learn your physician has diagnosed you with Opioid Use Disorder, be sure to ask them what criteria were used and why was it selected. Ask if you should see a doctor more knowledgeable about diagnostic codes and psychiatric disorders. 

Remember, knowledge is power. Take this information with you on your next visit to the doctor if you suspect you have been diagnosed with Opioid Use Disorder and your medications have been cut or reduced.

I hope what I have written helps you further understand exactly what we are facing and why. To be honest, it makes me want to wave the white flag, but I know that cannot happen.  We have to fight. Fight for proper care for a chronic disease or condition we didn't ask for or want. We can’t live the rest of our lives in severe, debilitating pain when effective treatment is available.  

Rochelle Odell lives in California. She’s lived for nearly 25 years with Complex Regional Pain Syndrome (CRPS/RSD).

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.

What Makes Buprenorphine Risky for Pain Patients

By Jane Babin, Guest Columnist

Buprenorphine is the darling of the addiction treatment industry, rapidly replacing methadone as the "medication assisted treatment" of choice for opioid use disorder (OUD) and addiction.  

Unlike methadone, which can only be dispensed through an opioid treatment program, buprenorphine can be prescribed in the privacy of a physician's office and filled at a pharmacy.  As a class III controlled substance, prescriptions for buprenorphine can be phoned or faxed in, and scripts can be refilled up to 5 times in 6 months without a new prescription.

Class II controlled substances, like hydrocodone, oxycodone and morphine, require a new prescription each month and can neither be refilled nor phoned in.

The only federal limitations on prescribing buprenorphine for OUD is that a physician must complete mandatory education and treat only a limited number of patients (currently 275). 

Ironically, these restrictions do not apply when buprenorphine is prescribed off-label for pain, leading some physicians and patients to turn to buprenorphine for chronic pain as class II opioids become increasingly harder to get.

Yet without training on buprenorphine’s unique pharmacology and its implications, physicians treating chronic pain may be unaware of the risks it presents. Let me explain why.

Buprenorphine’s Effect on Other Opioids

Buprenorphine is an opioid that acts as an agonist of the mu opioid receptor (MOR), which causes pain relief, just like class II opioids.  It also has side effects similar to other opioids, including tolerance, dependence, abuse potential, constipation, sedation and potentially fatal respiratory depression. 

What distinguishes buprenorphine from other opioids is that it is only a partial MOR agonist (50%).  Thus the effects of buprenorphine -- both pain relief and the undesirable side effects – don’t exceed half that of other, full agonist opioids.

Buprenorphine also has a ceiling of maximum effectiveness that reaches a plateau as the dosage is increased. That ceiling is well below what can be obtained with morphine and other opioids, but the side effects can still lead to death in opioid-naïve patients.  Buprenorphine has a long plasma half life, binds very strongly to MOR, and remains bound for extended periods of time.  Its usefulness in treating OUD is believed to lie in these properties, because it activates MOR sufficiently to curb drug craving, but not enough to elicit the euphoric effects that can lead to addiction. 

When an opioid that has higher analgesic potency, but lower MOR affinity, such as morphine or heroin, is also administered, buprenorphine wins the battle to bind and remains bound to MOR.  It can displace both heroin and naloxone from MOR, but neither can displace buprenorphine.  Naloxone can be effective when co-administered with buprenorphine -- as it is in combination drugs such as Suboxone -- but not after the administration of buprenorphine. 

Buprenorphine is also a kappa opioid receptor antagonist, which is thought to further reduce euphoria and addictive reinforcement. That’s great for patients with OUD, because it helps them resist the temptation to abuse opioids, and dampens or eliminates the euphoric effect of heroin or other opioids should they relapse.  

Increasingly, buprenorphine is being advocated for chronic pain patients.  With no more "proof" of efficacy for treating chronic pain than any other opioid, it has emerged as a less objectionable opioid because it appears safer in the eyes of addiction treatment specialists, such as Dr. Andrew Kolodny, who object to full MOR agonists for chronic pain. 

Yet safety is in the eyes of the beholder.  Despite its decreased abuse potential, buprenorphine can still be abused and cause overdoses because the ceiling effect for respiratory depression does not apply universally, particularly to opioid-naïve patients and children. Buprenorphine has caused the death of at least one child from unintentional exposure. 

Buprenorphine should not be used as the first opioid prescribed for chronic pain.  Because it cannot achieve the full analgesic effects that other opioids can, there is significant risk of buprenorphine leaving pain undertreated or even untreated.  A chronic pain patient on long-term buprenorphine therapy who experiences acute or breakthrough pain may not be able to get relief by taking another opioid.  Even more disturbing is the lack of pain control in patients who need surgery, have an acute injury from trauma or an acute painful medical emergency.

Buprenorphine Injection

Recently Indivior, a spin-off of Reckitt Benckiser Pharmaceuticals (which makes Suboxone), submitted a New Drug Application to the Food and Drug Administration on a subcutaneous injection formulation of buprenorphine. 

A once-a-month injection would be a significant advance for opioid administration because it would significantly reduce the risk of diversion.  A patient could hardly be accused of giving away or selling a drug that is deposited in his body, or of taking an incorrect dose.  

For this reason alone, an opioid depot formulation for a chronic pain patient with monthly administration sounds very appealing.  It might eliminate the need for pain contracts, pill counts, urine drug testing, and other indignations chronic pain patients suffer every day.  Even if another medication was needed for breakthrough pain, and drug testing was deemed necessary, the depot formulation would provide a virtually indisputable level of medication that could serve as an "internal control" for test error.  Detecting the depot med at unexpected levels would alert the prescribing physician to the inaccuracy of the test rather than suggest misuse or abuse.

Nevertheless, buprenorphine is not the right opioid for once-a-month dosing.  In a 2015 paper, lead author Dr. Yury Khelemsky described a horrifying case that illustrates the dangers inherent in daily buprenorphine use.  In this case, a patient with a history of drug addiction who was being treated successfully with Suboxone suffered a broken neck that required emergency surgery.

During the procedure, the anesthetized patient began to move in response to surgical stimulation, i.e., due to pain.  Despite increasing the amount of two anesthetics, Propofol and Reminfentanil, the patient continued to move.  Only after receiving yet another drug (Ketamine) did the patient remain motionless during the delicate procedure.  During a subsequent back surgery following discontinuation of Suboxone and replacement with short-acting opioids, roughly half as much Propofol and Remifentanil provided adequate anesthesia without the addition of Ketamine. 

Khelemsky noted that as little as 8 mg Suboxone (one third of the daily dose the patient was receiving), blocks the activity of hydrocodone for up to five days, and recommended discontinuing buprenorphine at least 72 hours prior to elective surgery.  This is cold comfort to a patient requiring emergency surgery -- which could be anyone.  

An injectable depot formulation of buprenorphine would substantially increase the risk of severe and possibly untreatable pain in an emergency situation, since a depot, once injected, cannot simply be discontinued as a pill would be.  Indeed, surgery may be needed to remove the depot and halt continued administration, while existing amounts of long-acting buprenorphine in plasma may necessitate higher, riskier doses of anesthetic to surgically treat the acute injury -- all while risking inadequate pain treatment.

Inexplicably, the extensive prescribing information on a random sample of buprenorphine products contains no warnings to either patients or prescribers of the risk that pain relief from an acute medical condition, trauma or surgery may be inadequate, or that buprenorphine should be discontinued days or weeks before elective surgery. 

Ironically, one package insert warns that additional analgesia may be required during childbirth, yet it fails to warn of any other situation that may require analgesia, or how analgesia can be accomplished when considering the unique pharmacology of buprenorphine.  

This seems to reflect the mindset of Kolodny and others in the addiction treatment industry, who always seem to minimize the significance of even the most severe pain encountered by an individual when compared to the perceived societal consequences of addiction.  I wonder how many pain patients or addicts would choose such a long-acting opioid if they understood the possibility that their severe acute pain could not be controlled.

The FDA committee tasked with reviewing Indivior’s new drug application is taking public comments.  I urge anyone concerned about this new buprenorphine formulation, and the failure to warn of the possibility of untreatable acute pain when taking any buprenorphine product, to provide comments by clicking here.

Comments can be submitted through October 27, 2017.  If received by October 17, they will be provided to the committee, which is scheduled to meet on October 31.  Comments received after October 17 will be taken into consideration by the FDA. 

Jane Babin, PhD, is a molecular biologist and a biotechnology patent attorney in southern California.

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.

Business Booming for Illegal Online Pharmacies

By Pat Anson, Editor

One of the many unintended consequences of efforts to reduce opioid prescribing is that they may be fueling the growth of illegal online pharmacies.

According to one estimate, as many as 35,000 online pharmacies are in operation worldwide. Over 90 percent are not in compliance with federal and state laws, many do not require a prescription, and about half are selling counterfeit painkillers and other fake medications. About 20 illegal online pharmacies are launched every day.

“There is no sign that this is slowing down,” says Libby Baney, Executive Director of the Alliance for Safe Online Pharmacies (ASOP), an industry supported non-profit.

“You have people (losing) their access to healthcare, not just pain care, but just general care. You have the opioid epidemic. You have the well-intended policy responses to that. All of this has the potential, unintended consequence of sending people to the Internet.

“My biggest fear is that if you limit prescriptions to five days or seven days, or prevent access to medication altogether, and people search.”

Since 2015, counterfeit painkillers and other medications made with illicit fentanyl have killed Americans in at least 16 states, according to a recent report that found the highly dangerous pills have spread from coast to coast.

"A lot of these people are buying it on the street or the Internet," Dr. Karen Gunson, Oregon’s medical examiner, told The Oregonian. "They think they're buying oxycodone or Xanax pills but they don't know what they're getting.''

What pain medications can you buy online? Oxycodone, hydrocodone, Percocet, Vicodin, tramadol and other painkillers can easily be found online, along with other controlled substances that are becoming harder for patients to obtain legally.

“There are thousands of websites that have figured it out and people are using them,” says Baney. “Most of these sites are based offshore. They may be using some U.S. servers, U.S. bank accounts or U.S. domain registrars, but nearly all are offshore. And that creates law enforcement hurdles.”

Last month the Food and Drug Administration announced a crackdown on over 500 online pharmacies that were accused of selling illegal and potentially dangerous medications. Warning letters were sent on September 19, giving the website operators 10 days to stop selling unapproved or misbranded prescription drugs.

Twenty days later, most of them are still online selling the same medications.

In a chat today with “Peter” at one of the websites that received a warning letter, I was told that I could purchase 80mg tablets of oxycodone without a prescription. Another website offered to ship us medications “placed inside baby doll as gift to ensure customer privacy and safe delivery.”

Baney says many of the illegal online pharmacies act as marketing agents for foreign drug suppliers.

“You don’t even need to have your own drug supply,” she said. “All you have to do is join an affiliate network and basically become a third-party marketer for an existing drug network.

“They give you the website template. They have the bank account setup. All you need to do is put up the site and process orders, and you get a cut and they get a cut, and they ship the drugs. It’s a pretty slick deal.”

Baney says it’s relatively easy to tell the difference between a legitimate online pharmacy and an illegal one. The URL’s for websites that end with “.Pharmacy” (not .com or .net) are certified by the National Association of Boards of Pharmacy and are in compliance with laws and practice standards.

You can also visit buysaferx.pharmacy to verify whether a website is legitimate.

The ease and convenience of ordering medications online – as well as the demand and profitability -- haven't gone unnoticed. According to CNBC, Amazon in the next few weeks will decide whether to enter the $560 billion prescription drug market with an online pharmacy of its own.

Why I Keep a Pain Journal

By Barby Ingle, Columnist  

In 2002, I was in what was thought to be a minor car accident. After months of getting worse, noticing new symptoms and doctors telling me it was all in my head, I set out to find answers that made sense for what was happening to me. 

Many of the medical tests that were performed did not show any problems. Even so, my symptoms were still bad and getting worse. I started physical therapy about a month after the accident, which was excruciating and seemed to make things worse.

Flash forward three years, and I found my way to a pain clinic here in Arizona. My doctor took the time to listen to my history and examine me.  The thought of being examined again by a new doctor was frightening. After an hour with me, the doctor said I might have Reflex Sympathetic Dystrophy (RSD), a painful neurological condition. A test later confirmed I had RSD -- as all my signs and symptoms had pointed to for all that time. 

After finding so little information out there about RSD and having so many doctors try to treat me who did not know about it, I realized that I was the one who had to teach my caretakers.

Many doctors who are not connected with a research hospital or university do not have the time to stay up-to-date with the latest information on RSD and other chronic illnesses. RSD does not always respond to treatments that relieve other types of chronic pain. Even among RSD patients, there are different responses to treatment.

The condition affects many aspects of the patient's life in varying degrees. For me, the simple things are the toughest. Activities of daily living, personal grooming, and my social and personal life have all been affected. I was not prepared for a catastrophic injury and lost my professional life during the bad days of RSD. I have had to adjust my daily routine because of the difficulty of performing simple tasks. 

I also learned to participate in very limited leisure activities, as I had to find my tolerance levels and work within them. I used to be very athletic, and loved hiking, biking and dancing. I constantly worked out and trained my body. Now I have a limited exercise regimen.

Because of my pain, falls and blackouts, as well as medication side effects, I am no longer able to drive. I need assistance with shopping, cooking, remembering things and traveling. I am in constant need of assistance, which makes traveling, social activities, personal care and holidays more complicated.

I have difficulty sleeping, lack energy and experience stress in my daily life. All of these help the cycle of pain continue.

Over time, I have found that pre-planning for daily events, activities and trips is not something I should do out of convenience; it is something I have to do to be able to function at even a basic capacity.

When I started a daily journal, I found that prayer, having a low-stress lifestyle, and staying hopeful keeps me in a positive place mentally. It also helps me keep my records organized, allowing for better healthcare. I have learned not to sweat the small stuff, to let go of troubles from the past, and look for ways to better my future. With a good team around you, the same is possible for you.

Like most chronic pain conditions, RSD is an invisible disability, which makes it harder for people to “see” your pain. People often have misconceptions about people with disabilities, so I disclose my condition to anyone who will listen, to let them know that RSD exists, and that early detection and proper treatment are important for RSD patients to have any chance of remission.

The more people I educate, the better the chances will be that someone else with RSD will have it easier. I know what I live, I journal it and I want to help others. Maybe a journal will help you.

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.

FDA Approves Extended-Release Lyrica

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new extended-release version of Lyrica for the treatment of neuropathic pain. Lyrica CR is designed to be taken once a day, instead of the two or three doses recommended for Lyrica’s original formulation.

“Lyrica CR was developed to offer patients an effective treatment option with the convenience of once-daily dosing,” said James Rusnak, MD, Chief Development Officer in Pfizer’s Global Product Development. “It provides an important option for patients and health care providers managing these often debilitating pain conditions.”

Pfizer said the effectiveness of Lyrica CR was established in a clinical trial of over 800 patients with neuropathic pain. Patients who took Lyrica CR had a 74% reduction in pain, compared to about 55% who took a placebo. The most common side effects of Lyrica CR were dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth and weight gain.

Lyrica (pregabalin) is one of Pfizer’s top selling drugs, but the company will likely face strong competition from cheaper generic versions of pregabalin when its U.S. patent expires next year.

Pfizer is undoubtedly hoping that current Lyrica users will switch over to the new extended release version, which will have full patent protection for many years to come. The company did not release any information on the cost of the new drug, which is expected to be available in January.

Unlike the original formulation of Lyrica, which is widely prescribed to treat fibromyalgia, Lyrica CR is only approved to treat nerve pain caused by diabetic peripheral neuropathy and postherpetic neuralgia caused by shingles. But that won’t stop doctors from prescribing it off-label to fibromyalgia and other chronic pain conditions.

Pregabalin Under Scrutiny

The extended release version of Lyrica comes at a time when pregabalin is drawing new scrutiny from researchers and doctors who believe the medication is over-prescribed and being abused. Pregabalin belongs to a class of nerve drug known as gabapentinoids, which are increasingly being prescribed as alternatives to opioid pain medication.

 “We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” Christopher Goodman, MD, and Allan Brett, MD, recently wrote in a commentary published in The New England Journal of Medicine. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain.”

As PNN has reported, the World Health Organization and the FDA are also investigating reports that pregabalin is being abused. Addicts have learned pregabalin enhances the effects of heroin and other opioids.

“Reports indicate that patients are self-administering higher than recommended doses to achieve euphoria, especially patients who have a history of substance abuse, particularly opioids, and psychiatric illness. While effects of excessively high doses are generally non-lethal, gabapentinoids such as pregabalin are increasingly being identified in post-mortem toxicology analyses,” the FDA said in a recent notice published in the Federal Register.

The warning label for Lyrica CR will caution users that the drug can be abused.

“Patients should not drink alcohol while taking Lyrica CR. Patients may have more dizziness and sleepiness if taking Lyrica CR with alcohol, narcotic pain medicines, or medicines for anxiety. Patients who have had a drug or alcohol problem may be more likely to misuse Lyrica CR,” the label warns.

Pregabalin is classified as Schedule V controlled substance in the U.S., which means it has a low potential for abuse.

Report Finds ‘Rush to Judgment’ in Kratom Deaths

By Pat Anson, Editor

Medical examiners in New York and Florida made significant errors when they attributed the recent deaths of two young men to the herbal supplement kratom, according to a new analysis commissioned by the American Kratom Association, a pro-kratom consumer group.

At issue are the sudden deaths of Matthew Dana in upstate New York in August and Christopher Waldron in Hillsborough County, Florida in July. Both men were 27.

A medical examiner listed Waldron’s cause of death as “intoxication by Mitragynine,” one of the active ingredients in kratom. The coroner who performed the autopsy on Dana blamed his death on a hemorrhagic pulmonary edema (blood in the lungs) caused by high levels of kratom.

“In both of these cited cases, the conclusions reported by the coroner and medical examiner citing ‘kratom overdose’ and ‘kratom intoxication’ appear to add to the long list of mistaken, inaccurate, and now discredited reports implicating kratom,” wrote Jane Babin, PhD, a molecular biologist and lawyer.

“These two cases, where it appears there was a rush to judgment to align with a political narrative promoted by the Drug Enforcement Administration on kratom use, undermine the credibility of the search for the actual cause of death for the benefit of the decedent’s family and the public.”

Babin said mitragynine has never been found to cause a pulmonary edema, and the medical examiner erred in not analyzing Dana’s blood for drugs such as anti-anxiety medication or anabolic steroids. Dana was a police sergeant and bodybuilder, who reportedly used steroids as part of his bodybuilding program.

Babin said the medical examiner in Florida also “rushed to judgement” in blaming Waldron’s death on kratom. Two prescription medications used to treat depression and muscle spasms, Citalopram and Cyclobenzaprine, were also found in Waldron’s blood. Labels on both drugs warn they can cause coma or death when taken together. Waldron also had ventricular hypertrophy, an enlarged liver and thyroid disease, which may have contributed to his death, according to Babin’s report.

“What I see here are very troubling indications that these deaths may have been incorrectly attributed to kratom in the face of other causes, including possible anabolic steroid use in one case and contraindicated prescription medication interactions that could kill on their own,” said Karl Ebner, PhD, a toxicologist who reviewed the report.

“These families are owed the best evidence about what happened to their loved ones, not what would appear to be some conclusions that are incompletely supported by the current evidence."

Millions of people use kratom to treat chronic pain, depression, anxiety and addiction. Last year, the DEA attempted to list kratom as a Schedule I controlled substance, which would have made it a felony to possess or sell. The DEA said kratom was linked to several deaths, as well as psychosis, seizures and an increased number of calls to poison control centers  

The DEA suspended its plan after an outcry and lobbying campaign by kratom supporters.

"Last year, the DEA tried to demonize kratom. In 2017, the kratom community finds itself in the same situation all over again,” said David Herman, chair of the American Kratom Association (AKA). “This time, we are being told that two deaths were supposedly the result of kratom use.  Let me be very clear about this:  We do not believe that kratom caused these deaths.  That's what the science tells us.

“Given that there are millions of kratom consumers in the U.S., if this botanical was dangerous it would stand to reason that there would be thousands … or even tens of thousands of deaths … and that is absolutely not the case."

The AKA backed another study last year that found kratom has little potential for abuse and dependence. Most kratom users say the herb has a mild analgesic and stimulative effect, similar to coffee.

‘Opiophobia’ Leaves Millions Dying in Chronic Pain

By Pat Anson, Editor

More than 25 million people – most of them poor and living in developing countries – die each year in severe pain because they have little or no access to morphine and other painkillers, according to a new report.

A special commission created by The Lancet medical journal looked at pain care around the world and found major gaps in the availability of opioid pain medication. While opioid analgesics are relatively available in the United States and Canada, patients in many parts of the world have no access to them. In addition to the 25 million who die in pain, the commission estimated that another 35 million live with chronic pain that is untreated.

“The fact that access to such an inexpensive, essential, and effective intervention is denied to most patients in low-income and middle-income countries and in particular to poor people -- including many poor or otherwise vulnerable people in high-income countries -- is a medical, public health, and moral failing and a travesty of justice,” the Lancet commission found.

"Unlike many other essential health interventions already identified as priorities, the need for palliative care and pain relief has been largely ignored, even for the most vulnerable populations, including children with terminal illnesses and those living through humanitarian crises."

The voluminous report by 61 health experts from 25 countries took three years to prepare. It shared the story of a doctor in India who treated a patient named “Mr S” who suffered crippling pain from lung cancer. The doctor was able to provide him with morphine to relieve his pain, but when Mr S returned the next month, no morphine was available.

“Mr S told us with outward calm, ‘I shall come again next Wednesday. I will bring a piece of rope with me. If the tablets are still not here, I am going to hang myself from that tree.’ He pointed to the window. I believed he meant what he said,” the doctor said.

The commission said there were several barriers that stood in the way of effectively treating pain, including “opiophobia” – prejudice and misinformation about the medical value of opioids.

“A prevalent but unwarranted fear of non-medical use and addiction to opioids and opioid-induced side-effects, both among health-care providers and regulators and among patients and their families, has led to insufficient medical use. Unbalanced laws and excessive regulation perpetuate a negative feedback loop of poor access that mainly affects poor people,” the commission said.

“Efforts to prevent non-medical use of internationally controlled substances, such as morphine and other opioid analgesics, have overshadowed and crippled access to opioids for palliative care. These efforts have focused on preventing diversion and non-medical use rather than ensuring access by people with legitimate health needs.”

The commission also blamed the poor state of pain care on a tendency in the medical community to focus on curing and preventing disease, rather than preserving a patient’s quality of life and dignity.  

The report recommends that palliative care be included as part of universal health care coverage and that inexpensive morphine should be available “for any patient with medical need.”

PNN Survey Shows Strong Support for CVS Boycott

By Pat Anson, Editor

There is widespread support for a boycott of CVS for planning to have its pharmacists impose strict limits on the supply and dosage of opioid pain medication, according to a PNN survey of over 2,500 pain patients, caretakers and healthcare providers.

Nine out of ten (93%) said they would support a boycott of the pharmacy chain, which has nearly 10,000 retail locations nationwide.

“I already have to jump through multiple hoops to get my pain medication prescriptions. It is not the place of CVS to monitor or alter my prescriptions. That is my doctor's job,” one patient told us.

“My Rx needs have been determined by my physician and my case history,” another patient wrote. “CVS does not have my history, nor have they been seeing me as a patient. Therefore, they have no business dictating or changing the regimen my physician has set to try to help me control my chronic pain.”

CVS Health announced last month that its pharmacists would only provide a 7-day supply of opioids for acute, short-term pain. CVS will also limit the dose of opioid prescriptions – for both acute and chronic pain -- to no more than 90mg morphine equivalent units (MME). 

The policy begins February 1 and applies to about 90 million customers enrolled in CVS Caremark’s pharmacy benefit management program, which provides pharmacy services to over 2,000 health and insurance plans.

Many of the healthcare providers who responded to the online survey resent the idea of a pharmacist changing a doctor’s prescription or refusing to fill it.

WOULD YOU SUPPORT A BOYCOTT OF CVS?

“It is no one’s business how I prescribe but mine and the patient,” one doctor wrote.

“It is wrong on all levels. As a health care provider I am appalled by it,” said another.

“Pharmacies should not be interfering in doctor patient relationship and treatment. There are more and more rules and regulations, and where does it stop before you have tyranny? Their rule basically will accomplish nothing positive. I would also encourage others to boycott,” a healthcare provider wrote.

CVS Customers Support Boycott

Patients, caretakers and healthcare providers all support a boycott about equally. So did nearly 92 percent of those who identified themselves as current CVS customers.

“Treating patients like they are drug-seeking criminals is just plain cruel. Our lives are hard enough without having to jump through hoops to get even a few minutes of relief. I will never fill another prescription at CVS pharmacy,” one patient wrote.

“I have gone to the local CVS for my scripts for years because they had the best prices,” wrote another patient. “But since I heard about this new policy I refuse to even set foot in a CVS.”

“They (CVS pharmacists) think they are my doctor with rude comments to me and other customers. They are too big for their britches. I am switching to Walgreens,” another patient wrote.

“A boycott will happen whether organized or not. Patients who need more than 90 morphine equivalent mgs will have to take their business elsewhere,” said another patient.

“Boycotting solves nothing. A letter writing campaign or calls to corporate to voice our opinions would be a better way to explain why we disagree with the new policy,” another patient suggested.

There is still a fair amount of confusion about the CVS policy. Many chronic pain patients are worried the 7-day limit on opioids applies to them (it does not) and others believe a pharmacist doesn’t have the legal right to refuse to fill a doctor’s prescription (they do).  

CVS says “the prescriber can request an exception” if a patient needs a larger dose or more than a 7-day supply, but hasn’t released details on how that would work or how long it would take.

The pharmacy chain says its opioid policy is designed to “give greater weight” to the Centers for Disease Control and Prevention's opioid guideline, which discourages primary care physicians from prescribing opioids for chronic pain. But the CVS policy actually goes far beyond the voluntary recommendations of the CDC, making them mandatory for all physicians and for all types of pain.  

As PNN has reported, preventing abuse and addiction may not be the only reason behind CVS’ decision. In recent years, the company has been fined hundreds of millions of dollars for violations of the Controlled Substances Act and other transgressions, many of them involving opioid medication.

“Corporate self-interest is impetus for this policy. This CVS ploy is to avoid further scrutiny by the DEA and avoid additional monetary penalties,” one patient wrote.

“Money and bad press is the only thing that large companies like CVS pay attention to. Until the leadership and major investors feel some considerable financial pain themselves, they will continue to make or support decisions that hurt and endanger the lives of people in pain,” said another.

U.S. Pain Foundation Endorses 7 Day Limit

CVS is not the first pharmacy to adopt policies that limit the dispensing of opioids, but it is the first major chain to set a 7-day limit on opioids for acute pain. Several states have already adopted laws that limit new prescriptions to a few days' supply. The Pharmaceutical Research and Manufacturers of America (PhRMA), an industry trade group,  recently announced its support for a 7-day limit, as did a patient advocacy group.

“We are on board with limiting new prescriptions for acute pain, but we do believe there should be a specific, written exemption for chronic pain, palliative pain, and cancer pain in order to ensure they are protected,” said Paul Gileno, founder and president of the U.S. Pain Foundation, which lists CVS Health and PhRMA as corporate sponsors on its website.

“A number of states, including Massachusetts, have adopted laws limiting first-time opioid prescription to seven days, and this part of the new CVS policy is consistent with these restrictions” said Cindy Steinberg, U.S. Pain’s national director of Policy and Advocacy. “We are in agreement with this limit for new, acute conditions; however instituting dosage limits for all patients is troubling.”

Not all of the comments in our survey were negative about CVS. Some patients expressed appreciation for CVS pharmacists who helped them save money with discounts or by suggesting cheaper medications. Others are happy to see any kind of action aimed at reducing opioid addiction. 

“It may anger some, but there is a major opioid problem in my area and sometimes it takes making a bold decision to create change, even at the risk of losing customers,” wrote one patient. “Notice nobody complains about CVS not selling cigarettes. They have lost billions in revenues since, but it was for the greater good of peoples’ health.” 

One healthcare provider is worried what will happen when her patients can’t get the pain medication they need.

“When that happens, we as providers become part of the problem because these patients will go to the street for help. They will do anything to get pain relief - not to get high. I won't boycott them but I think they ought to rethink what they are doing and the impact it will have,” she wrote.

“I have children with horrific chronic pain issues and other children who have had addiction issues that were not started with pain meds. I know both sides of this issue.”