The Case for Opioid Therapy

By Jordan LaMark, Guest Columnist

I take opioid pain medication and I am not ashamed of it. I refuse to feel guilty for needing medication.

I am not an addict. I do not deserve to be treated like a criminal – and for that matter, neither do addicts. I should not have to jump through hoops, be subjected to intense scrutiny, and constantly be forced to prove how much pain I’m in to receive my medication. It shouldn’t be a battle to receive treatment.

I live with Ehlers Danlos syndrome, a chronic incurable condition that causes daily unceasing pain. The pain wears at me, saps my energy, and severely restricts my functionality.

I also battle many other symptoms -- chronic fatigue, nausea, dysfunction of my autonomic nervous system, and failure of my digestive tract that requires me to be fed by a surgically implanted feeding tube (which is also very painful, and has altered my core muscles and posture). I sometimes need a wheelchair to get around and often cannot leave the house for days.

I spend most of my time dealing with my medical conditions. My pain medication gives me some relief and improves my functionality without negative side effects. I also use many other techniques to deal with my pain, including several forms of therapy, and I’ve had two surgeries to treat severe endometriosis.

Despite all of this, I am a happy person and do as much as I physically can, spending time with my family, going to church and daytime events, even the beach. Now, however, I am afraid that there may come a point when I may be unable to obtain the medication that improves my quality of life.

JORDAN LAMARK

There is no doubt an opioid abuse problem in our nation. However, the answer is not to enact reactionary laws and restrictions that make it harder for patients with a legitimate need to receive their medication. The conversation about opioids has been focused on acute patients and those who have had surgery or an injury, but has neglected to mention the unintended victims of anti-opioid campaigns: chronic pain patients who will most likely need medication for the rest of their lives.

Neglected also is that most of the abuse of prescription opioids takes place outside of the doctor-patient relationship. The World Health Organization tells us the risk of dependence and diversion is low when opioids are prescribed for pain. Studies also show that physician prescribed opioids are not the primary source of diversion and that theft from the drug distribution chain is an important source of illicit pain medication.

The CDC, along with other organizations and federal and state governments, has overstepped its authority by releasing a set of guidelines for opioid prescribing. Although the guidelines do not prohibit the prescription of opioids, they have increased the complexity and effort involved in getting them. This has had the same effect as declaring them illegal. Most doctors that I’ve talked to flatly state that they don’t prescribe opioids anymore.

I recently saw a pain doctor at one of the best hospitals in the country and was told that their policy is to not prescribe opioids to non-cancer patients. When asked what I should do, since in my case other methods either have not worked or cannot be used due to side effects, the doctor said he did not have a suggestion and wished he could prescribe them for me, but was unable to.

Many patients are having their dosages reduced in response to the CDC guidelines, and some are left with the heart-wrenching prospect of having their medication completely cut off. Many are now being forced to undergo monthly drug tests in order to receive treatment, even when there is no reason to suspect abuse. Our criminal justice system treats suspects as “innocent until proven guilty,” but the same logic does not seem to apply in this case.

I have personally had a pharmacist at a major chain refuse to fill my prescription and lie about the reason why, and then make negative comments about it to my face. I have had several doctors express concerns about legal action and increased government interference in opioid prescription, and cite these as reasons for not prescribing.

One pain specialist gave me several reasons that doctors are now hesitant to prescribe opioids. Number one, of course, was public and government pressure, followed by the increased complexity of prescribing and the fear of losing his license.

Another reason cited was the lack of an “equation” to tell doctors what and how much to prescribe. I think that is a faulty argument. Psychiatric drugs, for example, do not have such an equation or rubric --that is left up to the doctor’s discretion, as it should be.

I have been denied coverage for a treatment because my condition was not on my insurance company’s list of those approved to receive the treatment. Someone who had never met me decided he or she knew better than my doctor (and I) what potentially life-saving treatment I could receive.

Doctors often suggest “alternative treatments” such as cognitive behavioral therapy, which is usually not covered by insurance; acupuncture, which is almost never covered; and physical therapy, which becomes very expensive even with insurance if you are going several times a week for months. Medical marijuana is not covered and is prohibitively expensive. These alternative therapies, while worth trying, do not help everyone.  ­

If the medical industry and government are really serious about promoting alternative, non-opioid therapies, then they should be made affordable. Continuing to say “opioids are bad” and promoting restrictive laws does not stop illicit drug use and only hurts those who need them. These decisions should not be made by insurance companies or the government, they should be up to the individual physician and patient.

I have a feeding tube that was surgically placed and has forever altered my body. I have an open wound that causes pain and infections. The surgery carried risk, the act of changing the tube every few months carries a risk, and the tube’s mere presence is a risk. And yet, it’s all worth the risk because it keeps me alive. My pain medication takes the life that the tube has saved and makes it a life worth saving.

The medical industry does not have to bow to public or political pressure. This is the time for doctors and patients to stand up and reject reactionary responses. Do not take away the only relief many of us have.

Jordan LaMark lives with Ehlers-Danlos Syndrome and comorbid conditions, including Mast Cell Activation Syndrome (MCAS) and gastroparesis, for which she has a permanent feeding tube.

Jordan is the founder of Digesting that Facts, a website about living with her various medical conditions that includes educational information and research articles.

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.

Safeway Fined $3 Million for Painkiller Thefts

By Pat Anson, Editor

Safeway has agreed to pay a $3 million fine to settle allegations that it failed to timely report the theft of tens of thousands of hydrocodone tablets from pharmacies in Alaska and Washington state. The company also agreed to a compliance agreement with the Drug Enforcement Administration to ensure such lapses do not happen again.

The DEA learned of the hydrocodone thefts at Safeway pharmacies in North Bend, Washington and Wasilla, Alaska in April 2014, months after Safeway discovered the pills were stolen by employees. Under federal law, pharmacies are required to notify the DEA of the theft or significant loss of any controlled substance within one business day of the discovery of the theft or loss.

A DEA investigation of the case was later widened to review practices at all Safeway pharmacies nationwide between 2009 and 2014.  The investigation revealed a “widespread practice” of Safeway pharmacies failing to timely report missing or stolen controlled substances. 

“At this crucial juncture in our efforts to combat abuses of prescription drugs, it is imperative that pharmacies notify DEA immediately when drugs are stolen or missing.  A quick response to such reports is one of the best tools DEA has in stopping prescription drug diversion,” said DEA Special Agent in Charge Keith Weis.

As part of the settlement, Safeway will close a pharmacy in Belmont, CA and will suspend filling prescriptions for controlled substances for four months at a pharmacy in North Bend, WA.

“Safeway cooperated fully with government investigators throughout the investigation and remains an active partner with the DEA, local law enforcement and the communities it serves in the fight against prescription drug abuse, including the abuse of opioids,” the company said in a statement.  “Since early 2015, the Company has significantly enhanced its controlled substance monitoring program and implemented a variety of improved policies and procedures to enforce compliance with the Controlled Substances Act.”

Safeway is the latest in a string of pharmacy operators that have been fined for failing to comply with the Controlled Substances Act.

Last week CVS Health Corp agreed pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone. In January, Costco paid nearly $12 million to settle allegations that its pharmacies filled invalid prescriptions and failed to maintain accurate records at two central fill locations in Sacramento, California and Everett, Washington.

“We call on all participants in drug distribution to carefully monitor their practices to stem the flow of narcotics to those who should not have them,” said U.S. Attorney Annette L. Hayes.  “Pharmacies have a key role to play in making sure only those with legitimate prescriptions receive these powerful and potentially addictive drugs, including by timely reporting losses of those drugs.  Failure to do so hamstrings DEA’s investigative abilities and frustrates some of our best methods at curbing abuse.” 

New Opioid Painkiller Has Less Abuse Potential

By Pat Anson, Editor

A new opioid medication being developed by Nektar Therapeutics for the treatment of moderate to severe chronic pain has significantly less abuse potential than oxycodone -- even at high doses – according to the results of a new clinical study.

The investigational oral drug – known as NKTR-181 -- is the first analgesic opioid designed to reduce side effects such as euphoria, which can lead to abuse and addiction.

In a small study involving 54 recreational drug users, NKTR-181 had significantly less “drug liking” than oxycodone in the first hours of use. The dosage given to the study participants ranged from a maximum therapeutic dose of 400mg of NKTR-181 to a “supratherapeutic” dose that was 3 to 12 times higher than common doses of oxycodone.

"It is clear from our new study results that NKTR-181 is highly differentiated in this respect from oxycodone, which is a choice drug of abuse.  Further, and critically important in the context of this public health emergency, NKTR-181's less rewarding properties and strong analgesia are inherent to its novel molecular structure and independent of any abuse-deterrent formulation,” said Ivan Gergel, MD, Senior Vice President and Chief Medical Officer of Nektar. 

“Many patients do not receive adequate pain relief because they fear taking conventional opioids, including abuse-deterrent formulations, because of their potential for abuse and addiction.  We believe NKTR-181 is a transformational pain medicine that should significantly advance the treatment of chronic pain and could be a fundamental building block in the fight against prescription opioid abuse.”

nektar therapeutics

In March, NKTR-181 received “fast track” designation from the Food and Drug Administration -- a status that allows for an expedited review of the drug – after Nektar reported positive results from a Phase 3 study of over 600 patients with chronic back pain.  Pain scores dropped by an average of 65% in patients taking NKTR-181 twice daily.

The molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier, which slows its rate of entry into the brain – thus reducing the “high” or euphoric effect. Many pain sufferers say they do not get high or experience euphoria from opioid medication, but drug makers and regulators are working to develop painkillers with less risk of abuse and addiction.  

"Getting very high, very fast, is a mark of conventional high-risk, abused opioids," said Jack Henningfield, PhD, vice president at Pinney Associates and adjunct professor at The Johns Hopkins University School of Medicine. "NKTR-181 represents a meaningful advance in the treatment of pain as the first opioid analgesic with inherent brain-entry kinetics that avoids this addictive quality of traditional opioids. This prevents the rapid 'rush' that abusers seek during the critical period immediately after dosing. Importantly, these properties of NKTR-181 are inherent to its molecular structure and are not changed through tampering or route of administration." 

Because NKTR-181 produces less euphoria, Nektar believes it should be scheduled as a Class III or Class IV controlled substance, a less restrictive schedule than Class II medications, a category that includes oxycodone, hydrocodone and many other opioids.

Nektar is a research-based biopharmaceutical company that discovers and develops new drugs for which there is a high unmet medical need. It has a pipeline of new investigational drugs to treat cancer, auto-immune disease and chronic pain.

Lessons from Dreamland About the Opioid Crisis

By Roger Chriss, Columnist

The book Dreamland: The True Tale of America's Opiate Epidemic by Sam Quinones has become a playbook for many lawmakers, regulators and journalists covering the opioid crisis. It is an award-winning book from 2015 that describes the rise of Mexican “black tar” heroin, pill mills and opioid addiction starting in the 1980’s.

It is not a book about persistent pain disorders or the people who endure them using opioid medications.

Quinones interviews heroin couriers and addicts, as well as prescription opioid addicts. He describes heroin smuggling, heroin distribution networks, prescription opioid diversion, carefully crafted medical opioid scams, and misleading marketing by opioid manufacturers. But chronic pain patients do not appear in Dreamland at all.

Early in the book, Quinones brings up a 1980 research letter in The New England Journal of Medicine and the work of Russell Portnoy, both of which are alleged to have contributed to opioid overprescribing. But the overprescribing does not involve people with chronic pain disorders. Instead, Quinones explains that “in the Rust Belt, another kind of pain had emerged. Waves of people sought disability as a way to survive as jobs departed.”

And overprescribing did not necessarily mean over-consumption. As Quinones states, “Seniors realized they could subsidize their retirement by selling their prescription Oxys to younger folks. Some of the first Oxy dealers, in fact, were seniors who saw the value of the pills in their cabinets.”

Such opportunities were not ignored. More conventional drug dealers moved in and unscrupulous physicians opened drug-dealing clinics that we now call pill mills.

Quinones explains how to recognize a pill mill: “I asked a detective, seasoned by investigations into many of these clinics, to describe the difference between a pill mill and a legitimate pain clinic. Look at the parking lot, he said. If you see lines of people standing around outside, smoking, people getting pizza delivered, fistfights, and traffic jams—if you see people in pajamas who don’t care what they look like in public, that’s a pill mill.”

The importance of pill mills to the opioid crisis cannot be understated.

“It helps that OxyContin came in 40 and 80 mg pills, and generic oxycodone came in 10, 15, 20, and 30 mg doses—different denominations for ease of use as currency. The pill mills acted as the central banks, controlling the ‘money supply,’ which they kept constant and plentiful, and thus resisted inflationary or deflationary spikes,” wrote Quinones.

Dreamland goes on to explain that in rural Appalachian communities an underground economy arose with prescription opioids as currency, supported by scamming Medicaid and Social Security disability. Some addicts funded their habit by shoplifting at stores like Walmart and paying dealers for opioid pills with their stolen goods. Other addicts worked with dealers to scam Medicaid to pay for opioids from pill mills or to get opioids from legitimate clinics using forged medical records.

Opioid addiction was also driven by high school and college sports. Quinones explains that “after the games, some of the trainers pulled out a large jar and handed out oxycodone and hydrocodone pills - as many as a dozen to each player. Later in the week, a doctor would write players prescriptions for opiate painkillers, and send student aides to the pharmacy to fill them.”

Thus, the opioid crisis is a tragic result of a confluence of forces, including heroin sold under a business model virtually impervious to traditional law enforcement techniques and legal opioid pills used illicitly. As Quinones explains at the end of the book, “One way to view what happened was as some enormous social experiment to see how many Americans had the propensity for addiction.”

None of this involves medical opioids being used for pain management in people with chronic, progressive, or degenerative disorders. Quinones frequently mentions “chronic pain” but never defines the term precisely. However, his examples consistently refer to ongoing pain from a workplace accident, sports injury or accidental trauma -- not the persistent pain of a medical disorder. He does not interview pain management specialists or chronic pain patients because that is not the point of the book.

However, he does acknowledge the opioid crisis is having an unintended effect on people with persistent pain disorders. Quoting Quinones, “Patients who truly needed low-dose opiate treatment for their pain were having difficulty finding anyone to prescribe it.”

That is the lesson that Dreamland offers but too few people are learning. The opioid crisis is a dire manifestation of a larger problem of substance abuse. It is not about people with chronic pain disorders becoming addicted to opioids and then turning to heroin, an outcome that is exceedingly rare.

If we don’t understand what this book offers, we risk making the same mistakes that many lawmakers, regulators and journalists keep making. We’ll misunderstand the true nature of the opioid crisis and mismanage the response. And that will harm both opioid addicts and chronic pain patients, two groups that have already suffered enough.

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.

The Importance of Understanding Research

By Janice Reynolds, Guest Columnist

Almost daily we are told that a study shows this or research shows that, a physician makes claims based on research, or the news media blaring “New Study Shows.” 

Even worse, more and more frequently we are seeing providers, government and the media basing their opinions or actions on poor evidence -- or many times the total lack of it.  I have a tee shirt which says: “Show me the evidence and critical thinking.”

It is time for people in pain as well as their advocates to understand research studies and hold accountable those that are cited.

Evaluating research is a little complicated and time consuming, but it is something every medical person needs to do.  More importantly, the media needs to justify their reliance on research and identify that what they are saying is true, rather than something totally lacking in validation and objectivity (which unfortunately is most often the case). 

After all, the media claim to do careful research before doing a story. Politicians should also have accountability for objective truth.

As people living in pain, our arguments and comments are more effective if we show that we know what we're talking about.  It may not change someone's mind if they are opiophobic or dislike and distrust people in pain, but it’s important to try.

I’ve made repeated requests to the Portland Press Herald to give me the citations for their claim that “studies have shown conclusively that opioids not only don’t work for chronic pain but make it worse.” I haven’t changed their minds, but it is ammunition in the battle for actual truth.

These are some of the terms the public and people in pain need to understand:

Correlation and causation: Probably the most important.  Just because something happens at the same time, does not mean one thing “causes” the other.    My husband teaches statistics at a university and the example he uses is when the number of new boat licenses increases the number of manatees being killed. This does not mean boat licenses kill manatees.  This correlation means causation thing is rampant in media stories about pain.

Anecdotes and surveys:  An anecdote is an account not necessarily true or reliable, because it is based on personal experience rather than facts or research.  For every anecdote, there are often many more which tell a totally different story. An example would be: "My son died of an opioid overdose. We have to stop these drugs from killing people." Any death is tragic, but opioids do not in themselves kill people. 

Surveys also rely on someone’s self-reporting.  The one used extensively by the media and politicians is that 3 in every 4 heroin addicts got their start taking prescription opioids. That particular survey relied on addicts to tell the truth, did not not include addicts outside of treatment, and most importunately did not include millions who have taken opioids for pain and never even touched heroin.  Surveys and anecdotes are worthless as evidence.   

Case studies:  These are things that happened to a person, group or situation at a single time and/or place; i.e. a case history.  The CDC makes use of case studies to “prove” in their seminars the correctness of their opioid guidelines.  Case studies are of interest, but are not valid evidence for the same reasons anecdotes are not.

Data mining: This is the process of collecting, searching through, and analyzing a database to discover patterns or relationships. In our case, it usually means they have gone through death certificates, insurance records and the like.  Once again, this is not a source of evidence as there is no way to verify the validity of the data, as well as other confounding factors.  Data mining is the CDC’s favorite method and it has been shown to be highly inaccurate. It does not have a place in medicine, except to develop insights and lead to actual research.

Statistics: These by themselves do not mean much. Researchers need to use the appropriate statistical analyses before publishing them.  Medical providers, media and politicians need to acknowledge what analysis method was used and what the outcomes were.

Qualitative vs quantitative: Qualitative research gathers information that is not in numerical form. For example, diary accounts, questionnaires, case studies and anecdotal accounts are used to gain an understanding of underlying reasons, opinions and motivations. Qualitative data is typically descriptive data and as such is harder to analyze than quantitative data. It can never be “proof.”

Quantitative research looks at numbers, it is the “hard” science. Quantitative research is used to quantify the problem by way of generating numerical data that can be transformed into useable statistics that can be evaluated.

Objectivity: Objectivity means being aware and honest about how one's beliefs, values and biases affect the research process. This also applies to the reviewing, reporting, and selection of research.  The media especially lacks objectivity in their reporting of all issues related to people in pain and the “opioid addiction epidemic”.

Method:  How the study was done; meta-analysis, random controlled trials, non-random controlled trials, survey, cohort or case controlled study, or even expert opinion. The latter is only acceptable when no other research exists on the subject.

Sampling: The number of participants and who they were. A small number has a lower strength of evidence.  My favorite example of a “who” was a study done which claimed to show analgesics caused people to be homicidal.  Their sampling took place in a prison where all the participants were murderers!  Doesn’t take a rocket scientist to figure out this was biased.

Strength of evidence: This is probably the most important term when it comes to research.  There are many different tables used (easy to Google) that show a hierarchy of what is strong evidence, what is weak and what is non-existent.  Even the CDC recognized the evidence for their opioid guidelines was weak to non-existent. Most studies on the opioid epidemic or people in pain are inherently weak because the evidence is so poor.  

Proof:  Research seldom ever provides “proof.”  If multiple studies come up with the same results, then some might call it proof; however it is safer to say “likely.”  When talking about pain, medications, interventions or even addiction, the word “proof” should be off the docket.

Critical thinking: Critical thinking is the identification and evaluation of evidence to guide decision making. Another definition is making reasoned judgments that are logical and well thought out, a way of thinking in which you don't simply accept all arguments and conclusions you are exposed to, but rather question such arguments and conclusions. 

Those who are prejudiced and biased against people in pain or opiophobic rarely use any critical thinking skills at all.  In fact, after a comment I had made on a newspaper article, someone assassinated my character by saying my head was filled with mashed potatoes and I lacked any critical thinking skills whatsoever.  There was more and it was pretty funny.  This unfortunately is characteristic of the media, politicians and general public. No matter what we say or how truthful our comments, they will not hear. 

Evidence based: This means looking at best available clinical evidence from methodical research.  The word term is thrown around lightly and unless you have the actual “evidence” to back it up, it is meaningless. 

Several years ago, I was part of the original Pain PEP (Putting Evidence into Practice) team for the Oncology Nursing Society. We studied pharmaceutical interventions for nociceptor and neuropathic pain in the adult cancer patients. It took us two years to evaluate recent guidelines and research studies, and to write our guidelines based on the strength of the evidence. If you say something is “evidence based,” be prepared to show it.

One last comment on the issue of research and pain management: There are integral difficulties in pain research as people vary in their reaction to pain, the cause of their pain, and how they respond to treatment. Any research that uses the term “chronic pain” is already working with a false premise because there are so many different types of pain that are persistent.  Any research that looks at a “class” of medication such as opioids or antidepressants is also employing a false basis as well.

Pain management is an art and a science, and any attempts to standardize it will only harm people in pain.  

Janice Reynolds is a retired nurse who specialized in pain management, oncology, and palliative care. She has lectured across the country at medical conferences on different aspects of pain and pain management, and is co-author of several articles in peer reviewed journals. 

Janice has lived with persistent post craniotomy pain since 2009.  She is active with The Pain Community and writes several blogs for them, including a regular one on cooking with pain. 

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

Full Court Press on Opioid Pain Medication

By Pat Anson, Editor

A full court press is a defensive basketball tactic in which a team applies relentless pressure on an opponent the entire length of the court.

This past week felt like a full court press against prescription opioids, with government regulators, politicians, and even economists weighing in on the opioid crisis – almost all of them pointing a finger of blame at pain medication.

Where to begin?

On Tuesday, sixteen U.S. senators wrote a letter to the head of the Drug Enforcement Administration asking the agency to make further cuts in the production of hydrocodone, oxycodone and other opioid pain medications in 2018. The DEA has already reduced the supply of Schedule II opioids by 25 percent or more in 2017.

The letter, which was signed by 15 Democrats and one independent -- many from states where deaths from heroin and illicit fentanyl have eclipsed those from painkillers -- doesn’t even mention the role of illegal drugs in the overdose crisis, pinning the blame solely on pain medication.

“In order to effectively combat this raging crisis, stakeholders -- especially our federal oversight agencies -- must use every tool available to prevent the flood of addictive narcotic painkillers onto the market that can result in misuse, abuse, and diversion,” said the letter.

On Thursday, the Food and Drug Administration signaled that it was prepared to use some of those tools. An FDA funded report by the National Academies of Sciences, Engineering, and Medicine called for a national campaign to combat the opioid crisis, including more aggressive regulation of opioid medications and a “cultural change” in the way they are prescribed.

At the same time, the report warned that the illicit and prescription drug markets are "intertwined" and that "regulatory efforts designed to reduce harms associated with the use of prescription opioids may be contributing to
increased heroin use."

FDA commissioner Scott Gottlieb, MD, welcomed the report with a lengthy statement that completely ignored the role of heroin and illicit fentanyl in the opioid crisis.

“I’ve asked my FDA colleagues to take a fresh look at some key features of the agency’s regulation of opioids, including provider education, benefit-risk assessment in the pre- and post-market setting, and steps we can take to reduce overall exposure to these drugs,” Gottlieb said.

‘Extreme Amount’ of Opioids Prescribed

Also on Thursday, the Department of Health and Human Services’ Office of Inspector General (OIG) published a widely cited and inflammatory report claiming that over half a million Medicare beneficiaries were receiving high doses of prescription opioids.  The estimate is based on the premise that a daily morphine equivalent dose (MME) greater than 120 mg is a “high amount” and a dose of 240 mg or more is an “extreme amount.”

Those would be high doses for most pain patients, but not for Rick Martin, a retired Nevada pharmacist disabled by severe chronic back pain. Martin says he needs up to 300 mg (MME) of opioids daily just to be able to stand and walk for any length of time.

“I am really really incensed about the OIG using the word ‘extreme’ in defining people who take greater than 240 MME/day.  This is shouting fire in the movie theater,” Martin wrote in an email to PNN. “Patients who have long term persistent pain are where they are due to the medical community failing to correctly diagnose and treat what is causing the pain in the first place.  

“So in the OIG's eyes, not only am I a chronic pain patient on long term monitored opioid prescription medications, I am now considered EXTREME ! What a degrading moniker that is. In 6 months, I'll be called an EXTREME OPIOID ABUSER.  That's the next level to come down the pike.”

Like the senators’ letter to the DEA and the FDA study, the OIG report virtually ignores the illegal drug trade, instead blaming patients and providers for the opioid crisis. The report estimates that 400 doctors have “questionable” prescribing practices and 22,000 Medicare beneficiaries are doctor shopping.

“The extreme use of opioids and apparent doctor shopping described in this study put beneficiaries at risk and may indicate that opioids are being prescribed for medically unnecessary purposes and then diverted for resale or recreational use. It may also indicate that beneficiaries are receiving poorly coordinated care,” the report says.

On Thursday, the Justice Department also announced a nationwide crackdown on health insurance fraud and the illegal distribution of prescription opioids. Over 400 people were arrested nationwide, including many doctors, nurses and healthcare providers.

"While today is a historic day, the Department's work is not finished. In fact, it is just beginning. We will continue to find, arrest, prosecute, convict, and incarcerate fraudsters and drug dealers wherever they are,” warned Attorney General Jeff Sessions.

Opioid Crisis Affecting Job Market

Surprisingly, it was left to economists to take a more nuanced view of the opioid crisis – noting there are many other factors involved besides pain medication

Federal Reserve chair Janet Yellen told the Senate Banking Committee that economic despair was one reason that the labor force participation rate remains stubbornly low, despite declines in the unemployment rate.

“Unfortunately this is likely tied to the opioid crisis, the problems that many communities have. We’ve seen an increase in death rates due to despair, suicide, drugs in these communities,” Yellen said, adding that the United States is "the only advanced nation that I know of where in these communities we're actually, especially among less-educated men, seeing an increase in death rates partly reflecting opioid use."

Yellen was reacting in part to a Goldman Sachs report  which blamed opioids of all kinds – both legal and illegal – for keeping millions of Americans unemployed during their prime working years.

“Use of both legal prescription pain relievers and illegal drugs is part of the story of declining prime-age participation, especially for men,” economist David Mericle wrote in a research note that attributed a spike in overdoses to “heroin and illicit fentanyl users, most of whom previously used prescription opioids but switched to these cheaper, more accessible drugs.”

Trump Opioid Commission Delays Report

Curiously silent during a week full of opioid news was the White House Office of National Drug Control Policy, which quietly postponed the second meeting of President Trump’s Opioid Commission.  A notice published in the Federal Register Friday said the commission’s second meeting has been postponed until July 31, the second time the meeting has been rescheduled.  No explanation for the delay was given.

Also delayed was the commission’s interim report on how the federal government should address the opioid crisis, which is now over a month overdue.

At the commission’s first meeting in June, testimony was taken only from government officials and addiction treatment advocates. Pain management experts and patient advocates were not asked to appear, nor are they represented on the commission itself.

Proove Biosciences Linked to Fraud Investigation

By Pat Anson, Editor

A genetic testing company in southern California has been linked to a nationwide crackdown on healthcare fraud that resulted in criminal charges being filed against hundreds of doctors, nurses and medical professionals.

Among the defendants are three individuals affiliated with Physicians Primary Care of Jeffersonville, Indiana, who are accused of unlawfully dispensing oxycodone, hydrocodone and other opioid medications to patients without a legitimate medical need.

The charges also allege that Jeffrey Campbell, MD, and nurse practitioners Mark Dyer and Dawn Antle "caused Proove Bioscience, Inc., a genetic lab company, to falsely and fraudulently bill various health care programs for genetic tests administered to Physicians Primary Care patients that were not medically necessary and never interpreted."

Proove Biosciences is not formally charged in the grand jury indictment, which was unsealed yesterday in the U.S. District Court of Kentucky in Louisville. In an emailed statement to PNN, Proove's founder and CEO said the company cooperated with authorities and terminated its contract with Dr. Campbell when it first learned of the investigation in 2014.

"Since then, Proove has cooperated with both the FBI and US Attorney’s office on this case," said Brian Meshkin. "With regards to tests being 'medically necessary', Proove received written and signed determinations of medical necessity supporting the tests ordered and billed to insurance carriers just like every other laboratory which requires such a determination on a test requisition form. Thus Proove operated appropriately and consistent with usual and customary practices."

As PNN has reported, Proove’s headquarters in Irvine, California was raided by FBI agents last month, along with doctors affiliated with Proove in California, Florida and Kentucky. At the time, the FBI would only say the raids were part of a healthcare fraud investigation.

STAT News reported in February that the FBI and the Inspector General for the Department of Health and Human Services (HHS) were investigating possible criminal activity at Proove. Former and current employees interviewed by the FBI said agents were focused on illegal kickbacks to doctors who encouraged patients to take Proove’s DNA tests. Physicians reportedly could make $144,000 a year in kickbacks that were called “research fees.”

"Proove has been subject to a handful of inaccurate stories,” Proove said in a statement last month.  “We can no longer ignore these false stories based on unreliable sources, and filled with erroneous accusations... spread by a few disgruntled former employees and consultants.”

In all, 412 defendants have been charged nationwide in what the Justice Department calls its “largest ever health care fraud enforcement action.” Most of the charges, according to prosecutors, involve the illegal distribution of painkillers and $1.3 billion in various billing schemes that targeted Medicare, Medicaid and TRICARE, a health insurance program for veterans and their families.    

Attorney General Jeff Sessions said nearly 300 health care providers were being suspended or banned from participating in federal health programs.

“Too many trusted medical professionals like doctors, nurses, and pharmacists have chosen to violate their oaths and put greed ahead of their patients,” said Sessions. “Amazingly, some have made their practices into multi-million dollar criminal enterprises. They seem oblivious to the disastrous consequences of their greed. Their actions not only enrich themselves often at the expense of taxpayers but also feed addictions and cause addictions to start.”

Proove’s ‘Peer Reviewed’ Studies

Proove Biosciences promotes itself as a “leader in personalized pain medicine” and claims its genetic tests have been proven effective in clinical studies at identifying medications that can best treat pain and other health conditions. Critics say most Proove studies are not peer-reviewed and one genetic expert told STAT News the studies were “hogwash.”

Last month Proove claimed in a press release that 91% of patients in a peer-reviewed study reported pain relief after treatment changes prompted by its genetic tests. The press release said the study -- conducted by Katrina Lewis, MD, a member of Proove's medical advisory board who works at Benefis Pain Management Center in Great Falls, Montana – was “accepted for publication by the Journal of Addiction Research & Therapy.”

Not only has the study still not been published, but the journal’s publisher has been accused by the Federal Trade Commission (FTC) of deceiving researchers and readers about the true nature of its publications and peer review process.

According to the FTC complaint filed last August, OMICS International has created hundreds of "open access" online medical journals that publish articles with little or no peer review.

Researchers are also charged significant fees to get their articles published by OMICS, a "pay to play" policy that some consider unethical because it diminishes the quality of academic journals and the peer review process.

According to its website, OMICS publishes a dizzying array of over 700 online medical and scientific journals, ranging from the Journal of Hepatitis to the Journal of Yoga and Physical Therapy, "the official journal of Yoga Federation of Russia and the Hong Kong Yoga Association." 

“In reality, many of Defendants’ online publications do not adopt the rigorous peer review practices that are standard in the scholarly journal publishing industry,” the FTC complaint says. “In numerous instances, individuals who have agreed to serve as peer reviewers for Defendants either never receive any manuscripts to review or discover that, when they access the online manuscript review system to review their assigned articles, the articles have already been approved for publication. In addition, in numerous instances, consumers receive no edits or, at most, only stylistic edits before Defendants publish the work.” 

"As for the Journal of Addiction Research & Therapy, Proove can only speak to its experience with this particular journal and cannot comment on the allegations by the FTC," said CEO Meshkin. "Specifically for papers submitted to this journal, our R&D team and academic collaborators engaged in documented, extensive peer-review, received suggested edits and provided responses to the suggested edits to the manuscripts submitted for review and publication. Thus, Proove would certainly consider the publications accepted from Proove-affiliated authors in that journal to be 'peer-reviewed'." 

In March, OMICS published in the Journal of Addiction Research & Therapy a study by Proove which found that one of the company’s genetic tests could identify patients at high-risk of developing opioid use disorder. Proove said in a news release the study had been peer reviewed. 

In April, a second Proove study was published in Pharmacogenomics and Personalized Medicine, an online journal published by Dove Medical Press, another so-called predatory publisher that charges high fees to researchers to get their studies into medical journals.

"This is the first of many peer-reviewed publications over the next several months demonstrating the validity of Proove Opioid Risk (test), building on the existing published evidence," Dr. Svetlana Kantorovich, Proove's Research and Development director said in a news release.

FDA Study Calls for More Aggressive Opioid Regulation

By Pat Anson, Editor

A new report commissioned by the U.S. Food and Drug Administration is calling for a sustained and coordinated national campaign to combat the opioid crisis, including more aggressive regulation of opioids by the FDA and a “cultural change” in the prescribing of opioid medication,

The report by a special committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) focuses primarily on restricting the supply of prescription opioids, not illicit opioids such as heroin and fentanyl, which are now driving the so-called opioid epidemic.

"The broad reach of the epidemic has blurred the formerly distinct social boundary between prescribed opioids and illegally manufactured ones, such as heroin," said committee chair Richard Bonnie, a Professor of Medicine and Law at the University of Virginia.

“This report provides an action plan directed particularly at the health professions and government agencies responsible for regulating them. This plan aims to help the millions of people who suffer from chronic pain while reducing unnecessary opioid prescribing. We also wanted to convey a clear message about the magnitude of the challenge. This epidemic took nearly two decades to develop, and it will take years to unravel."

The report estimates that at least 2 million people in the U.S. have an “opioid use disorder” involving prescription opioids -- meaning they are addicted to prescription painkillers -- and almost 600,000 have an opioid use disorder involving heroin.

Although opioid prescribing has been declining and the number of overdose deaths from prescription opioids has remained relatively stable in recent years, deaths from illicit opioids such as heroin have tripled in the past decade.

NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINES

The report claimed that many people who normally would use prescription opioids have transitioned to heroin because of the declining price of heroin and the introduction of abuse-deterrent formulations that make opioid medication harder to snort or inject. The Centers for Disease Control and Prevention (CDC) has said there is no evidence to support the theory that legitimate patients are transitioning to heroin.

"Evidence does not support the hypothesis that initiatives intended to reduce opioid prescribing increase illicit opioid-related overdose at a population level," Deborah Dowell, MD, of the CDC recently wrote in the Annals of Internal Medicine.

The NASEM committee recommended that further efforts be made to restrict the supply of opioid medication, even though there is “limited evidence” that steps taken so far are working and may, in fact, be harming patients.

“Although more research is needed, limited evidence suggests that state and local interventions aimed at reducing the supply of prescription opioids in the community may help curtail access. Importantly, however, none of these studies investigates the impact of reduced access on the well-being of individuals suffering from pain whose access to opioids was curtailed,” the report states.

The NASEM report also recommends broader insurance coverage of non-opioid treatments.and better education of physicians in pain management.

“The committee’s recommended changes to provider education and payer policy should be accompanied by a change in patient expectations with respect to the treatment and management of chronic pain. Attention is not being paid to educating the general public on the risks and benefits of opioid therapy, or the comparative effectiveness of opioids with nonopioid or nonpharmacologic therapies,” the committee said.

The committee also recommended that the FDA conduct a full review of currently approved opioids and that it consider “public health considerations” in all of its regulatory decisions. Such a policy would require the agency to not only consider the safety and efficacy of opioids for legitimate pain needs, but also their impact on addicts and the illicit drug market.

“I was encouraged to see that many of NASEM’s recommendations for the FDA are in areas where we’ve already made new commitments,” FDA commissioner Scott Gottlieb, MD, said in a statement.  “Among these important new actions is our work to ensure drug approval and removal decisions are made within a benefit-risk framework that evaluates not only the outcomes of opioids when used as prescribed, but also the public health effects of the inappropriate use of these drugs.”

Last month the FDA asked that the opioid painkiller Opana ER be removed from the market, not because it was harming legitimate pain patients, but because addicts were abusing it and spreading infectious diseases through infected needles. It was the first time the agency has taken steps to remove an opioid from the market.

“These are just some of the important efforts we have underway. But to make a meaningful impact, this epidemic must be addressed as a public health emergency, and requires an all-of-the-above approach. As underscored in the NASEM report, the scope of this epidemic is so large, it’s going to require a coordinated effort that includes federal, state, and local partners,” Gottlieb said.

The NASEM study was funded by the FDA.

Free Programs That Help Pay for Prescription Drugs

By Barby Ingle, Columnist

I decided to write about the high cost of prescription drugs because I am personally experiencing it and also hearing from other patients who cannot afford their medications. I found a program that can help and wanted to make sure that this information gets out to others who need proper, cost-contained, and timely access to care.

Last year I had my first experience with abandoning a prescription at the pharmacy. I developed asthma symptoms and was given a first-time script for a bronchodilator inhaler medication. My primary care provider gave me 2 free samples in his office and warned me that getting the inhaler could be expensive.

When I went to pick it up the first time, I learned that my insurance co-pay was more than $100. I am doubly insured through a group health plan/PPO through my husband’s insurance, as well as having Medicare as my secondary. If I am having trouble financially with my co-pays, then I know others must be as well.

I just couldn’t afford the inhaler and told them to put it back on the shelf. That was when my Walgreens pharmacist suggested that I Google a free savings program like WellRx and see if they had any discounts for the medication I needed.

I did find a discount card online at WellRx.com that helped save on the inhaler and I was able to fill the script after all. I would have never thought of doing something like this without the suggestion of my amazing pharmacist. The WellRx savings program works well for insured people with high out-of-pocket costs like me.

I have faced this situation two more times, one with a medication I was taking daily for years. The co-pay went up so high that without a savings card, I would not be able to pay for it.

The other medication I had to abandon because I couldn’t afford it, even though the savings program provided 50% off what my insurance was going to cover. Nevertheless, it was worth the look to see if I could find a discount. My provider had to substitute the medication for a different one that I could afford, although I am not sure if it worked as well as the one he originally prescribed.

I know how awful and embarrassing it feels to have to abandon a medication at the pharmacy, while you work to come up with a way to pay for it and know that you may never be able to pick it up. Now, I have my pharmacist price the medication through insurance and the WellRx program to see which is less expensive.

Recently a study was published in the Annals of Internal Medicine that showed a direct correlation between the amount of a patient’s out-of-pocket cost and the likelihood of a prescription being abandoned. They concluded that when patients have a co-pay of over $50 they are four times more likely to abandon their prescription than patients who only owe $10.

Leaving a prescription at the pharmacy and failing to follow a doctor’s instructions can lead to major health challenges, such as a condition worsening, increased side effects and symptoms, therapeutic failure, increased medical costs, and in some cases even death. A 2008 Harvard prescription study suggested that opiates, anti-platelets and statins were the least likely to be abandoned, while insulin and proton pump inhibitors were more likely to be left behind.

This is not a new issue for pharmacies, but it has become more common over the past few years. Besides cost, some other reasons for abandoning medications at the pharmacy include e-prescriptions, drug strength, taking the medication for the first time, and not understanding why the medication was prescribed.

But for me and many others, it all comes down to cost. Studies show that the higher the patient’s responsibility financially, the greater the risk of prescription abandonment. The second highest reason for abandonment is younger customers who are wary about the trying a new medication.

The take away for me is that prescription discount cards and pharmaceutical coupons can increase medication compliance, improve patient health, and lower the cost of medical care. I know that by getting the cost down for my medications, I will be more likely to comply with my doctors’ instructions.

The WellRx program I used was free. I wasn’t sure how it was going to work the first time, but the pharmacist just said print the savings card and bring it back. He did the rest for me. He knew exactly how to ring it into their register and didn’t seem to bat an eye or look down at me for using a savings card. They also have an app for Apple and Android phones for those who prefer everything digital.

WellRx also allows you to compare what the price will be at different pharmacies in your area and to search for the best discounts. It is quick and easy, and their program is accepted at more than 60,000 pharmacies across the country. They offer an average savings of 45% off the prescription cost and some of their medications are eligible for savings of up to 80 percent.

Another resource that can help is the Partnership for Prescription Assistance, which helps uninsured and underinsured patients connect with hundreds of public and private assistance programs that provide free or low-cost prescription drugs.

LowestMed has a free mobile app that allows you to research and compare prescription prices at pharmacies in your area. You then show the discounted price on your phone to a participating pharmacy. The price you see is the price you pay.

I love being able to pass savings tips on to others. Prescription discount programs are a great tool not only for the chronically ill, but also for healthy people who have an unexpected medical problem and need help paying for their prescriptions.

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.

16 Senators Urge DEA to Lower Opioid Supply Again

By Pat Anson, Editor

Sixteen U.S. senators have sent a letter to the head of the Drug Enforcement Administration asking the agency to consider further cuts in the supply of hydrocodone, oxycodone and other opioid pain medication in 2018.

The DEA, which regulates that amount of controlled substances that can be manufactured each year, reduced the quota for Schedule II opioids by 25 percent or more in 2017 after receiving a similar letter last summer.  The supply of hydrocodone, one of the most widely used painkillers, was cut by 34 percent.

“We commend DEA on taking initial steps last year to lower production quotas for the first time in a generation,” the senators wrote to DEA acting administrator Chuck Rosenberg.

“However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic.”

The letter, which was drafted by Illinois Democrat Dick Durbin, was signed by 15 other Democrats and one Independent: Senators Sherrod Brown (D-Ohio), Amy Klobuchar (D-Minn.), Edward J. Markey (D-Mass.), Joe Manchin (D-W.Va.), Dianne Feinstein (D-Calif.), Claire McCaskill (D-Mo.), Patrick Leahy (D-Vt.), Tammy Baldwin (D-Wisc.), Jeanne Shaheen (D-N.H.), Kirsten Gillibrand (D-N.Y.), Catherine Cortez Masto (D-Nev.), Maggie Hassan (D-N.H.), Richard Blumenthal (D-Conn.), Al Franken (D-Minn.) and Angus King (I-Maine).

Between 1993 and 2015, the senators say the DEA allowed production quotas for oxycodone to increase 39-fold, hydrocodone to increase 12-fold, hydromorphone to increase 23-fold, and fentanyl to increase 25-fold.

Production quotas may have been rising, but opioid prescriptions have actually been falling for several years.  Last week the CDC released a report acknowledging that opioid prescribing in the U.S. has fallen by 18 percent since 2010.  

Many PNN readers have complained that since the 2017 quotas were adopted they now have trouble getting legitimate prescriptions filled because pharmacies do not keep enough pain medication in stock.

“My pharmacy has been trying to fill my pain medication for 6 days now,” wrote Karen. “So I call my pain management office and (they) don't know there is a shortage! Help us get our medication!”

“I am horrified by the absolute stupidity of these lawmakers who have no business making any decisions about my pain management!” wrote Tracey, who has been taking pain medication for 5 years. “All of the lawmakers said this would not affect those with already established chronic pain! Well guess what they lied!”

“I am writing to each one of these senators and letting them know how I feel on this issue. We need to vote these people OUT of office come election time, send them a powerful message. Although at this point the damage is already done. People like myself shouldn't have to consider suicide to end their constant pain,” wrote Jenny.

While many patients complain of shortages, the senators who signed the letter talk about states being “flooded” with opioids.

“Pharmaceutical companies have irresponsibly flooded states with millions and millions of opioids pills – enough, in fact, for every adult in America to have their own bottle,” Sen. King said in a statement. “And the consequences are both clear and dire: As the number of pills has grown, so has the drug epidemic. By scaling back the overabundance of these opioids, the DEA can help directly stem the tide of addiction while still also ensuring that those who suffer from chronic pain have the medication they need.”

Drug Maker Pays $35 Million Fine for Opioid Sales

By Pat Anson, Editor

A British drug maker has agreed to pay a $35 million fine to settle allegations that it failed to report suspiciously large orders in the U.S. for the opioid painkiller oxycodone.

In the settlement, Mallinckrodt refused to admit any wrongdoing and said it was paying the fine “to eliminate the uncertainty, distraction and expense of litigation.”

Federal prosecutors say the company failed to detect and notify the Drug Enforcement Administration of unusually large orders for oxycodone from U.S. pharmacies and pain clinics from 2008 to 2011.  

The government also alleged that Mallinckrodt failed to keep accurate records at a manufacturing facility in upstate New York, which resulted in discrepancies between the actual number of oxycodone tablets produced and the number of tablets reported by the company.

“Mallinckrodt’s actions and omissions formed a link in the chain of supply that resulted in millions of oxycodone pills being sold on the street,” Attorney General Jeff Sessions said in a statement.

Prosecutors say the settlement includes a “groundbreaking parallel agreement” with the DEA, under which the company will analyze data it collects from customers down the supply chain to identify suspicious sales. The DEA maintains that drug makers need to go beyond a “know your customer” policy and should use all available data to “know your customer’s customer” to prevent opioid painkillers and other controlled substances from getting into the wrong hands.

“Mallinckrodt has agreed to do everything they can to help us identify suspicious orders in the future. And as a result of today's settlement, we are sending a clear message to drug companies: this Department of Justice will hold you accountable for your legal obligations and we will enforce our laws,” Sessions said.

"While Mallinckrodt disagreed with the U.S. government's allegations, we chose to resolve the legacy matter in order to eliminate the uncertainty, distraction and expense of litigation and to allow the company to focus on meeting the important needs of its patients and customers,” said Michael-Bryant Hicks, General Counsel, Mallinckrodt.

"We are proud of the fact that Mallinckrodt has long been an industry leader in actively combatting the serious issue of prescription drug abuse with a demonstrated record of meeting and exceeding the requirements of federal and state laws governing the manufacturing, sale and distribution of controlled substances.”

CVS to Pay $5 Million Fine

In a related story, CVS Health Corp agreed to pay a $5 million fine to settle allegations that several CVS pharmacies in California failed to detect thefts of the opioid painkiller hydrocodone.

“The Company agreed to settle this matter to avoid the delay, uncertainty, inconvenience and expense of protracted litigation,” CVS said in a statement. 

The allegations resolved by the settlement were uncovered by a DEA investigation that began in 2012 after CVS self-reported thefts and losses of hydrocodone at five of its Sacramento-area pharmacies. Under the Controlled Substances Act, pharmacies are required to report any thefts or significant losses of controlled substances to the DEA.

“National retailers that distribute massive amounts of controlled substances have a responsibility to comply with recordkeeping regulations because these regulations are specifically designed to prevent dangerous drugs from being diverted into the community and abused,” said U.S. Attorney Phillip Talbert.

In addition to paying the $5 million fine, CVS also agreed to a compliance plan for 168 its pharmacies in California, under which pharmacy staff would be provided with better training and monitoring.

“CVS Health is committed to the highest standards of ethics and business practices, including complying with all federal and state laws governing the dispensing of controlled substance prescriptions and is dedicated to helping reduce prescription drug abuse and diversion,” the company said. 

This is certainly not the first time CVS has been accused by the federal government of failing to comply with the Controlled Substances Act.

Last year CVS agreed to pay a $3.5 million fine to resolve allegations that 50 of its pharmacies in Massachusetts and New Hampshire filled forged prescriptions for opioid painkillers. One forger signed a dentist’s name on 131 prescriptions for hydrocodone and had them filled at eight CVS stores. Another forger obtained over 200 prescriptions for hydrocodone and methadone by forging the name of an emergency room physician.

In 2015, CVS paid a $22 million fine after two of its pharmacies in Florida were found to be routinely filling bogus prescriptions for painkillers, including some for customers as far away as Kentucky.

And in 2010, the DEA fined CVS $75 million for the improper selling of cold medicines in California and Nevada. The cold medicines contained pseudoephedrine, an ingredient that can be used to make methamphetamine.

9 out of 10 Patients Prefer Cannabis Over Opioids

By Pat Anson, Editor

A survey of nearly 3,000 medical marijuana users has found that 9 out of 10 patients prefer cannabis over opioid medication when managing their chronic pain. A similar number prefer cannabis over non-opioid pain relievers such as Tylenol or Advil.

The survey was conducted by researchers at the University of California Berkeley and HelloMD, a website that links patients to doctors in California and New York that prescribe medical marijuana. The survey was administered by email to a HelloMD database of cannabis patients who were asked how marijuana affected their consumption of opioids and other pain relievers.

Eighty percent of those surveyed said that cannabis was more effective at relieving pain than opioid medication and 97 percent said they decreased their opioid use when using cannabis. The latter finding supports previous research that found use of prescription pain medication declining in states where medical marijuana is legal.

“The results of our study were striking, showing 97% of people were able to decrease the amount of opioids that they used in conjunction with cannabis use. This was more than double the amount shown in any previous studies conducted,” said Perry Solomon, MD, Chief Medical Officer of HelloMD.

DRUG POLICY ALLIANCE

“The (study) clearly showed that chronic pain is one of the medical conditions that cannabis can be used for with great efficacy. Our study not only supports this but also goes further in that the clear majority of patient’s state that they prefer it. Hopefully this will awaken the public, medical professionals and legislatures to the fact that there is a safe, non-addictive product available to help fight the opioid epidemic, and that is cannabis.”

Other key findings from the survey of medical marijuana users:

• 93% said they prefer cannabis to opioids
• 92% said cannabis' side effects were more tolerable than side effects from opioids
• 90% said cannabis works well with non-opioid pain relievers
• 96% said they need fewer non-opioid pain relievers when using cannabis
• 89% said cannabis was more effective than non-opioid pain relievers

"With cannabis not only becoming more accepted in the mainstream but also coming in a variety of preparations, some of which are nonintoxicating, more people are looking at cannabis as a viable treatment for everyday ailments such as muscle soreness and inflammation,” wrote Amanda Reiman, PhD, of UC Berkeley and the Drug Policy Alliance, lead author of the study published in the journal of Cannabis and Cannabinoid Research.

“Participants in this study overwhelmingly supported the notion that they would be more likely to use cannabis as a substitute for pain medication if it were less stigmatized and more available, suggesting that there are populations of people who could benefit from this practice but are shying away due to the stigma and legal restrictions related to cannabis use.”

The survey should not be considered a scientific study on the effectiveness of cannabis, because participants were self-selected and reported their perceptions about cannabis use, as opposed to an objective measurement by a third party. There was also no control group of pain patients who only had access to opioids and other pain relievers.

A small study last year by the University of Michigan found that nearly two-thirds (64%) of medical marijuana patients reported a reduction in their use of prescription pain medications.

A 2014 study published in JAMA Internal Medicine found that opioid overdoses declined by nearly 25 percent in states where medical marijuana was legalized.

From Bad to Worse: The Future of the Opioid Crisis

By Roger Chriss, Columnist

The opioid crisis is getting worse. STAT News is predicting that “opioids could kill nearly half a million people across America over the next decade as the crisis of addiction and overdose accelerates.” The Guardian calls it “this generation’s AIDS crisis.”

There are three developments now at work that are likely to determine the future direction of the opioid crisis: Illicit drugs coming from China and Mexico; healthcare reform and funding for addiction treatment; and the White House Commission on Combating Drug Addiction and the Opioid Crisis, chaired by New Jersey governor Chris Christie.  

With opioid prescriptions dropping since 2010, heroin and illicit fentanyl are now the main drivers of the opioid crisis. The U.S. is trying to get China to shut down illicit labs and stop the shipment of fentanyl and other synthetic opioids to Mexican drug cartels. But The Globe and Mail warns that “hoping Chinese police and border officials can solve the problem is unlikely to be an effective strategy.”

The New York Times reports illicit drugs can also be obtained online over the “dark web” and attempts to block overseas shipments of such drugs have met with little success so far.

In the U.S. Senate, the GOP healthcare bill would allocate $2 billion to addiction treatment, but CNN reports that “those on the front lines say the bill won't help the opioid crisis -- and very well could make matters worse.” The reason, says Politico, is that “throwing a pile of cash at addiction won’t make it go away.”

Presidential advisor Kellyanne Conway echoes that belief, warning that “money alone hasn’t solved the problem. Obamacare spent billions of dollars and where are we?”

“It takes money and it also takes a four letter word called will,” she told ABC News, a comment that infuriated addiction treatment supporters.

Two Republican senators want to boost funding for addiction treatment to $45 billion, but experts say even that amount of money would be inadequate because it doesn’t provide for the treatment of other healthcare problems – like HIV and hepatitis C – that many addicts have.

Addiction treatment was the focus of the first meeting of the White House Opioid Commission, which was appointed by President Trump to come up with solutions to the opioid crisis.  During last month’s meeting, Mitchell Rosenthal, MD, founder of the addiction treatment chain Phoenix House, warned that “nothing we are doing today has been able to halt the spread of opioid addiction. Controlling prescription opioid medication has not done so.”

The commission has until October 1 to present its recommendations to President Trump, but the panel has already missed one deadline for an interim report and postponed its second meeting until next week.

As you can see, there are no easy solutions. The opioid crisis is a perfect storm of increasingly available illicit drugs, very limited and costly treatment resources, and virtually no early detection or prevention. We can’t simply legislate, regulate or incarcerate our way out.

Nothing less than a comprehensive and coordinated national response will end the crisis. We need early intervention and preventative education, long-term treatment of opioid addiction using medication-assisted therapy, and careful and humane oversight of prescription opioids that doesn’t take them away from patients who need them. What we will get remains to be seen.

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.

PROP Urges Members to Oppose FDA Opioid Strategy

By Pat Anson, Editor

An anti-opioid activist group has sent an “Urgent Action Request” to it members, asking them to oppose plans by the Food and Drug Administration to give new guidance to health care providers about prescribing opioid pain medication.

The initial draft of the guideline for Prescriber Education for Extended-Release and Long-Acting Opioids Risk Evaluation and Mitigation Strategies – more simply known as REMS -- warns prescribers at length about the risk of overdose, addiction and the “epidemic of prescription opioid drug abuse.” But Physicians for Responsible Opioid Prescribing (PROP) doesn’t think the draft goes far enough.

“The current draft is seriously flawed,” wrote PROP founder and Executive Director Andrew Kolodny, MD, in an email to supporters urging them to leave a comment in the Federal Register before the public comment period on the REMS guideline ends on Monday, July 10.

“Please post a comment about the draft on the FDA federal docket. FDA is required to review the comments and tally them. If FDA receives enough critical comments, there is a good chance they'll improve the document.” 

Kolodny’s email provides a “sample comment” for PROP members to use, urging the FDA to adopt an upper dose limit on opioids, mention the “lack of evidence supporting long-term opioid use” and provide a list of pain conditions for which opioids are “inappropriate” – such as fibromyalgia and chronic headache.

Until now, the REMS draft guideline – an update to a similar guideline released in 2012 – has drawn little public attention. Less than 300 comments have been made in the Federal Register, most of them focused on whether acupuncture and chiropractic care should be included as alternative treatments to opioids. 

The 10-page guideline warns doctors repeatedly about using caution when prescribing opioids, but it stops short of setting an artificial ceiling on doses, such as those recommended last year by the Centers for Disease Control and Prevention and an even tougher guideline recently adopted by the Departments of Veterans Affairs and Defense (VA/DOD).

“We believe the REMS curriculum should be based on the CDC guideline and the VA/DOD guideline,” wrote Kolodny and other PROP board members in a letter to FDA commissioner Scott Gottlieb, MD. “The CDC and VA/DOD guideline warn against prescribing high doses of opioids and specifically recommend against doses greater than 90mg morphine equivalents. The Blueprint omits this critical topic.”

“I don't agree that the new blueprint is inconsistent with recommendations from other government agencies. For one thing, there is a specific statement in the blueprint that HCPs (health care providers) should know about the CDC guideline and other guidelines regarding safe opioid prescribing,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, an organization of pain management providers.

“Let me also point out that PROP's call for inclusion of ‘an upper dose limit consistent with recommendations from other federal agencies’ perpetuates the myth that the CDC guideline contains such an upper dose limit. CDC was very clear when it issued the guideline that it should be considered to contain recommendations, not limits.”

The REMS guideline not only does not endorse a specific limit on opioids, it recommends that “a comprehensive treatment plan should be developed and customized to the needs of the individual patient.”  The focus on individualized patient care is something else that PROP takes issue with.

“Since the purpose of the Blueprint is to teach more cautious prescribing the focus should be first and foremost on when to use opioids for acute and chronic pain, and secondly, on how to use opioids as safely as possible. The Blueprint does not need to teach how to make a pain diagnosis, or what alternatives there are to opioids, both of which should be considered beyond the scope of REMS,” wrote Kolodny his his letter. “Until opioids are prescribed more cautiously it will not be possible to bring the opioid addiction epidemic under control.”

But opioids are being prescribed more cautiously and have been since 2010, as we learned from a new CDC study. Yet the nation’s opioid crisis continues to worsen, fueled by heroin, illicit fentanyl, counterfeit painkillers, and failed strategies to control the crisis by denying many pain patients their only form of treatment.   

To see the FDA’s draft REMS guideline, click here. To leave your own comment on the Federal Register, click here.

Are You Still Hoping for a Cure?

By Rochelle Odell, Columnist

As a 25 year survivor of Complex Regional Pain Syndrome (CRPS/RSD), I ask myself all the time if I have lost hope, become too cynical and if reality has finally hit home.

Yes to all three, unfortunately. And I don't like that.

For most chronic pain conditions, there is usually hope for a cure. But for some there is no hope at all -- people just have to learn to live with the outcome and hope there are doctors who know how to treat it accordingly.

When viewing the main CRPS/RSD websites and support groups, hope for a cure is a common thread. But in reality for me and others like me who have lived with this insidious monster for far too long, there truly is no hope. Medical treatment and modalities have changed little in the 25 years I have battled this disease and that concerns me.

Why haven't greater strides been made? Possibly because researchers and scientists just do not fully understand the human brain yet. Until there is a complete understanding of the mechanics of this disease and others like it, hope ends there.

I recently learned from a friend that her physician, a general practitioner, had little respect for anesthesiologists who treated post-surgical pain and how he felt a patient wasn't treated appropriately. So I looked into when pain management became its own medical specialty.

Pain management became the first sub-specialty of anesthesia in 1993, the same year that I was diagnosed with CRPS/RSD. Most pain management specialists are anesthesiologists, but neurologists and psychiatrists can also become board certified in pain management. The training is long and arduous, but they are among the highest paid in the medical profession.  

When my treatment began, my first pain management physician was still learning and I was his all too cooperative guinea pig. I just wanted the CRPS/RSD pain in my left foot to go away. Would I go down that path again? Never.

My outcome may have been much better without all the “minimally invasive” procedures that were attempted. It started with epidural blocks and progressed from there. The more procedures that were done, the faster the CRPS/RSD spread and the worse the pain became. 

I often wonder where the term “minimally invasive” began. Even though doctors may not go deeply into the body, just by going into our spine or brain for whatever reason, they are venturing into the very nerve fiber of every patient. That is not minimal.

I have read where researchers, scientists and even some pain management physicians now believe that all those minimally invasive procedures may in the end do more harm than good.  Do I believe it?  Absolutely!  But that's just me -- although many long term CRPS/RSD patients will admit that it was wrong for them too.  Most just do not go around talking about this other dark side of the pain. 

There are times I want to scream at a patient: DON'T DO IT! EXPLORE ALL YOUR OPTIONS FIRST. AND ABOVE ALL EDUCATE YOURSELF!

But I don't, I temper my tongue.

Many of us don't believe our physicians as we are rushed through an appointment. We may be allotted only about 10-15 minutes. If you haven't written down your questions and concerns first, you soon realize you are sitting in the exam room with your mouth open as the doctor leaves, telling you to pick up your prescription at the front desk, schedule your next appointment or, worse yet, that they will be unable to treat you any longer. 

This type of inadequate treatment, with your pain increasing and no end in sight, is where cynicism soon develops.  It is also when reality hits you smack in the face and you start to question yourself. What in the hell am I doing here?

When clinical trials are started, they are aimed at a specific group of people, often in the early stages of a disease. There is often a large exclusion list, such as those of us who have had CRPS/RSD for many years. New treatments are not being investigated or developed for us, so the standard nerve blocks, injections, surgical procedures and implants are utilized. And now, because of the opioid crisis, more patients than ever are being dropped.

Treating a CRPS/RSD patient has so many variables. What works for one, doesn't work for the other, and what worked yesterday may not work the next day. Treating us has to be a nightmare for any physician.

I do have hope for patients who are newly diagnosed with CRPS/RSD, absolutely. But at this point in time, unless medical advances are developed, they soon will be walking down the same path so many of us long time pain patients or on, when hope is dashed, and cynicism and reality make a grand entrance.

I get tired of hearing the word “hope” as it has no meaning for me. Yet we are continually told to hope for a cure, to be brave, and to develop a positive attitude. Am I all doom and gloom? Not yet. I still smile and laugh.

But when alone in the dark, when reality hits me once again, I cry. 

Rochelle Odell lives in California. She lives 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.