Living with Chronic Pain After Being Labeled an Addict

By Patricia Young, Guest columnist

I am writing this article from the perspective of a patient who has chronic back pain and also an unwarranted, doctor-imposed label of “addiction.”

As most people can imagine, having both of these problems -- chronic pain and a substance use disorder -- can be very difficult for a healthcare provider to manage. Imagine though how harmful it is when someone is diagnosed or labeled as an addict and it is not an appropriate diagnosis.

The new polite wording for addiction is "chemical dependence," "substance use disorder" or "opiate dependence."

But these terms are not helpful either, since they have the same meaning to most healthcare professionals, as well as the general public.

To make matters worse, I was totally unaware that this diagnosis was ever made and it was never explained to me that it would be in my medical record. I want to share some of the problems this has caused me.

The first time I thought something was wrong was when I found myself having severe eye pain. I called ahead to the emergency room to make sure they had an eye doctor available to see me and decided to go in when they said they did. Instead, I was examined by a physician’s assistant (PA) after he reviewed my medical records. He looked at my eye from a distance without using any diagnostic equipment, told me I had an infection, and gave me antibiotic drops for it. The eye drops only made the pain worse.

I thought it was odd since I had no eye drainage of any kind and never had such pain before with an eye infection. A few days later I learned I had a herpes sore in my eye. No wonder those eye drops didn’t work!

Not one medical doctor or PA had taken my pain seriously in the ER because I had been labeled as having “drug seeking” behavior. But I did not know that until much later.

At the time I was taking opioid pain medication prescribed by my doctor to treat chronic pain from a lower back injury and two back surgeries. Sometimes I have flare ups of severe pain in my left hip, groin and leg despite the prescribed opiate drugs.

I went another time to the ER in severe pain and was seen by another physician’s assistant. After looking at my medical record, the PA proceeded to tell me to get out of the ER as I lay there on a gurney. My husband and I had no understanding at the time why 3 security guards came and told me to get back in my wheelchair myself or they would pick me up and put me there.

My husband picked me up and we were escorted out the door. I was 59 years old, disabled and was no threat to anyone. It was at that point that I started to wonder what “red flag” was in my medical records to make them treat me like that.

Later I found out what that red flag was. A doctor had written down after one visit that I had a “history of addiction.” This was the first time I became aware of this. I really could not understand why since no medical person had ever said I may have this diagnosis or even mentioned the word “dependency” to me.

I later had to move to Florida from upstate New York because my disability made it hard to cope with harsh winter weather. After the move I had great difficulty finding a new primary care physician. I believe no doctor wanted me as a patient after they saw the diagnosis of “history of addiction.”

We all know how difficult it can be to deal with an individual with a drug addiction. It’s a diagnosis that follows people for a lifetime. Unfortunately, when it is made in error, it is very detrimental and can even be a factor in someone’s death. Not only can there be a huge physical ramification from a diagnosis of addiction, but it can do harm to a person’s mental and emotional health, as well as cause family problems. I know it has affected me that way. The diagnosis evokes many people to make judgements.

I had many angry responses from healthcare professionals in my times of real need. The ones that threw me out of the ER demonstrated their anger by tone of voice, gestures, and curtness. I felt hopeless leaving there and my husband was so stunned he had no words to say. It was a very dark time in my life that is difficult to forget.

It has been suggested to me that I now suffer with post-traumatic stress syndrome and anxiety. Doctors want me to take anti-hypertensive medications daily as a result. This very frustrating and damaging diagnosis has led me to distrust the very physicians I go to for help. My blood pressure is high in their offices but not at home.

I also wrestle now with the problem of feeling as if my reputation has been harmed. I am seen by doctors as untrustworthy and in denial since I disagree with the addiction diagnosis. The very medical system that I worked in for almost 35 years has now mislabeled me and treats me harshly at a time when I need care myself.

I strongly believe there needs to be more understanding within the medical community as well as the public arena about this problem. There is a definite difference between a physical dependence on a substance versus an addiction to it. An addiction diagnosis suggests that one has misused drugs and has a mental disorder.

I have been judged as one of those types of people and it’s wrong. I had many medical professionals come up to me and congratulate me for stopping my pain medication. I thought they were crazy. It was no mental feat to stop taking the drugs, but I must admit my body’s physical reaction was not good. That is normal for someone that has taken opioid pain medicine for a period of time.

It is time we stop hurting and stigmatizing pain patients in this manner. It just makes our pain worse and can even lead to serious mental health problems and in some cases suicide.

Please healthcare providers, make sure your diagnosis is made correctly. I believe that an addiction or dependency diagnosis should only be made by someone who is trained in addiction medicine and who specializes in treating addictive disorders.

Patricia Young lives in Florida.

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.

CDC: Prescription Opioid Abuse Costs $78.5 Billion

By Pat Anson, Editor

A new analysis by the Centers for Disease Control and Prevention estimates the total “economic burden” of prescription opioid abuse in the United States at $78.5 billion a year.

Researchers at the National Center for Injury Prevention and Control – the same agency that oversaw development of the CDC’s controversial opioid prescribing guidelines – analyzed economic data from 2013 associated with opioid abuse, including the cost of health care, lost productivity, substance abuse treatment and the criminal justice system.

“A large share of the cost is borne by the public sector, both through direct services from government agencies, but also through tax revenue that will be lost from reduced earnings. Also, the health care sector bears approximately one third of the costs we have estimated here,” wrote lead author Curtis Florence, a senior health economist at CDC.

Florence and his colleagues estimated that nearly two million Americans abuse or are dependent on opioids. Their study is published online in Medical Care, the official journal of the American Public Health Association.

 "More than 40 Americans die each day from overdoses involving prescription opioids. Families and communities continue to be devastated by the epidemic of prescription opioid overdoses.” said CDC Director Tom Frieden, MD, in a news release.

"The rising cost of the epidemic is also a tremendous burden for the health care system."

Exactly what that burden is is open to conjecture. The researchers admit that some of their data is flawed because they relied on death certificates codes – which often fail to distinguish between deaths associated with prescription opioids and those caused by heroin. Heroin users and prescription opioid users are essentially lumped together – even though heroin users are far more likely to enter the criminal justice system.

In addition, opioids associated with death were considered a sign of abuse even if multiple drugs were involved. No distinction was made if the deaths were accidental, intentional or undetermined.

“Our health care cost estimates used the definition of opioid abuse and dependence identified by ICD-9 diagnosis codes. This definition does not differentiate between prescription opioids and heroin,” said Florence. "We did not attempt to attribute costs to specific drugs if multiple types of drug abuse were reported. This could bias our results if the health care cost impact of abuse and dependence is different between prescription opioids and heroin, or if abuse of prescription opioids alone has a different effect from abuse of multiple drugs,”

The researchers also were unable to distinguish between the “nonmedical” use of opioids by someone who obtained the drugs illegally and those who obtained them legally through a prescription.  

“It is extremely difficult to measure all costs to society from an epidemic. In this case, there are many costs we were unable to measure, such as the reduction in quality of life of those who are dependent,” wrote Florence.

Despite these limitations, the CDC research team said their estimates should be considered by healthcare providers and regulators in deciding whether prescription opioids should be used to treat pain.

“In the ideal case, decision makers could use these estimates when weighing the benefits and risks of using opioids to treat pain, and evaluating prevention measures to reduce harmful use. However, at the present time a full accounting of both the benefits and costs of prescription opioid use is not available,” they wrote.

The CDC estimate of $78.5 billion as the annual cost of prescription opioid abuse is only a fraction of the total cost of chronic pain on society. Using data from 2008, researchers from Johns Hopkins University estimated that the economic cost of pain in the United States ranged from $560 to $635 billion annually.

The CDC’s opioid guidelines discourage primary care physicians from prescribing opioid for chronic pain. Although voluntary, anecdotal reports from patients and doctors suggest the guidelines are being widely adopted by many prescribers. Some states have even adopted the CDC guidelines as official policy or in legislation.

The CDC has released no estimate on the economic impact of its guidelines or on the reduction in quality of life for pain patients who are no longer able to obtain opioids.

Kratom Supporters Rally at White House

By Pat Anson, Editor

Hundreds of protestors chanting “kratom saves lives” and “I am kratom” rallied in front of the White House today, hoping to turn their passion for an herb into a movement that stops the Drug Enforcement Administration from making kratom illegal.

“This stuff saved my life. It gave me my life back,” said one protestor.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural medicine. In recent years, kratom has grown in popularity in the United States, where it is made into teas and supplements as a treatment for pain, depression, anxiety and addiction.

All of that may change on September 30th, when the DEA plans to schedule the two main active ingredients in kratom as Schedule I controlled substances -- alongside heroin and LSD. That would effectively make the sale and possession of kratom a felony.

Under its emergency scheduling order, the DEA invited no public comment and held no public hearings.

“Stop this ban immediately. You’re trying to protect your jobs. You’re not trying to save Americans,” said Ryan Connor, a military veteran who lost a sister to a heroin overdose. “If you take away this herb, more and more people are going to die."

Connor said he uses kratom to treat his own opioid addiction.

image courtesy american kratom assn.

“I’ve been on every opioid under the sun. I was on Suboxone. I was told it was a cure for addiction, but it did not cure my addiction. In fact, it made it worse. I used kratom to get off Suboxone. It was painless. I had zero side effects from it. And I think as Americans we have the right to choose our health over getting poisoned by pharmaceuticals,” Connor said.

In a notice published in the Federal Register, the DEA said an emergency scheduling of kratom was necessary because it has no approved medical use. The DEA claimed the herb was being used recreationally for its "psychoactive effects" and as a substitute for heroin.

The Centers for Disease Control and Prevention also issued a report last month calling kratom "an emerging public health threat." The agency said there were 660 calls to U.S. poison control centers about kratom in the last six years. About 8 percent of the calls involved a life threatening condition. One death was reported.

courtesy patti belmont

Kratom supporters say the death was more likely caused by prescription drugs and that kratom actually saves lives.

“It changed my life. It rescued me from a very severe addiction to narcotics. It took me out of a home and bed-bound existence. It gave me the energy and pain control that I needed,” said Susan Ash, who founded the American Kratom Association, which organized the rally outside the White House.

“We want a regular scheduling process that involves public comment and the best available science, and not just a note from the CDC that said they got all of 660 calls to poison control when they’re getting three to four million calls a year. How do 660 calls make an emerging public health threat?”

Kratom supporters have gotten over 120,000 signatures on an online petition asking the Obama administration to stop the DEA from scheduling kratom as a Schedule I substance. Under its "We the People" petition rules, the administration promises to "take action" on a petition within 60 days if supporters are able to gather at least 100,000 signatures.   

According to the website whpetitions.info, the average response time for a successful White House petition is well over 100 days – not 60 days. Six petitions -- including the kratom petition -- are currently waiting for a response.

Meanwhile, the Center for Regulatory Effectiveness (CRE), a government watchdog group, has asked the DEA to postpone the scheduling of kratom.

In a September 12 letter to acting DEA Administrator Charles Rosenberg, a CRE official pointed out that the National Institutes of Health has conducted research to explore the therapeutic value of kratom as a treatment for chronic pain and substance abuse.

“The research was so well conducted and received by the scientific community that the aforementioned institutions applied for a patent. How much more additional evidence is needed to demonstrate that the DEA has acted arbitrarily in issuing a ban on kratom?” asked Jim Tozzi, a member of the CRE Board of Advisors.

“In short, without going through a notice and comment process, DEA is obviating another agency’s research that was conducted with appropriated funds. With its action, DEA is also obviating the progress and promise of kratom research to boosting the American bio-sciences industry.”

Tozzi’s letter said the DEA’s “rush to judgement” may have violated the federal Data Information Quality Act and was a “clear and flagrant abuse of discretion.”

He asked the DEA to extend the effective date for scheduling kratom to July 1, 2017, to allow for public comment and a peer review of the science behind the agency’s decision.

Why Opioid Addiction Treatment Often Fails

By Percy Menzies, Guest Columnist

The two most contagious factors linked to addiction are accessibility of the drug and price. If there is easy access to the drug (and this includes alcohol), the number of people exposed is going to increase and a higher number will become addicted.

Every single epidemic has followed this principle. Let’s look at the present problem in the U.S. with the abuse and addiction to prescription opioids.

For decades access to prescription opioids was restricted to patients in acute pain and the only exception was terminal cancer pain. We did not have a major health crisis with opioids in the 1980’s and early 1990’s. 

Then in the mid 1990’s, articles and papers started appearing in the media and medical journals about the under-treatment of chronic pain. Respected clinicians and researchers made a strong case for using opioids to treat chronic pain. They insisted that opioid medication had little or no potential for abuse.  Clinicians were expected to treat chronic pain as the “fifth vital sign” and use opioids as a first-line treatment. The access door was thrown wide open and, for most patients, insurance covered the prescription cost.

When the alarm bells sounded years later and physicians cut back on prescribing, some patients who use opioids medically and many others who use them to get "high" found an alternative: heroin.  This illegal drug was relatively easy to obtain and the price was substantially lower than prescription opioids. 

Now heroin is becoming the gateway drug.  The potency of street heroin is increasing and there are many reports of heroin being laced with the very potent opioid fentanyl to increase the high. The DEA also tells us that hundreds of thousands of counterfeit pain medications made with illicit fentanyl are on the black market.

How do we fight this? Look at how we've reduced access to alcohol and cigarettes.

Access to alcohol is restricted by age, taxes on alcoholic beverages, licensing restrictions, campaigns against drunk driving and other measures. Policies to reduce smoking have also had dramatic results. The smoking rate in the U.S. has dropped from 50% to about 19% in the last twenty years. How was this achieved? By tightening access: no cigarette vending machines, no sale of single cigarettes, limits on places where people can smoke, and substantially higher taxes on tobacco products.

Look at addiction to cocaine. Cocaine was once glamorized as a drug that was only psychologically addicting. The abuse of cocaine and later crack cocaine skyrocketed in the 1980’s. In response, very harsh and discriminatory criminal measures were instituted, but with little effect. Some groups even advocated legalization.

The government promised effective treatments for cocaine addiction, including vaccines, but to date we have neither the treatments or vaccines. Yet addiction to cocaine is way down. Why? Because of reduced access. The countries growing coca came under increased international pressure and destroyed coca crops by spraying them with herbicides.  What would have happened if cocaine was legalized?

Legalization of a drug greatly increases accessibility and increases the number of people exposed to it.  The increased legalization of marijuana has made cannabis accessible to millions of people who never would have considered using it before. There are projections of marijuana becoming a $70 billion plus product in the next 5 to 10 years!

Accessibility undermines recovery.  The conventional treatment approach is to send patients away to residential programs for weeks and months.  The thinking is that behavioral and life skills learned during “rehab” will protect patients from relapsing when they return home. Does this really happen? Can patients successfully navigate the plethora of cues and triggers greeting them when they return home?  Will they be able to resist or ignore the ringing of the bell of Pavlovian conditioning?

It is not likely to work because of a well-researched phenomenon called Conditioned Abstinence or the Deprivation Effect. When a patient is sent away and deprived of access to a drug or alcohol, the addiction goes into an internal “incubator” where it is nourished by anxiety, exchange of war stories with other patients, and ruminating about drug use.

When the patient returns home to the familiar environment of past drug use, the fortified addiction powerfully reemerges from the incubator, leading the patient into relapse.

Repeated attempts at incarceration and long-term residential treatment have failed to curb high relapse rates, especially for opioid addiction.  This led to a wrong and highly controversial conclusion that addiction is a brain disease and the only approach is palliative treatment with other opioids, often for life.

The common and inappropriate analogy is to diabetes. Rather than looking at access as the contributing factor to relapse, patients are told they need opioids like methadone and buprenorphine to ease their withdrawal pains, much like diabetic patient needs insulin.  A clever but unproven theory called the “metabolic syndrome” was put forward to explain this. Patients are left feeling hopeless, helpless and resigned to their fate.

We need look no further than the U.S. soldiers that got addicted to heroin in Vietnam to debunk this theory. The addiction of some soldiers was spawned by cheap and easy access to heroin in villages and hamlets. Our country was in a state of panic about these soldiers continuing their heroin use when they returned home. There was even fear that their weapons training would be used to obtain the drug.

To everyone’s surprise, less than five percent of the soldiers continued using heroin when they returned home. Did these soldiers not suffer from the metabolic syndrome?  They did not continue their heroin habit because they had no easy access to heroin when they came back. If they had been sent back to Vietnam, many would have relapsed because they would have easy access again to heroin.

Compare this to the soldiers returning from Iraq and Afghanistan. Many have been able to continue the addiction because they have easy access to opioids and heroin in the U.S.

Palliation or substitution with methadone or buprenorphine has done little to blunt the heroin epidemic. We have not found a way to reduce access and indeed it is growing. A record quantity of potent heroin is flowing into this country from Mexico. The other two major producer countries, Afghanistan and Burma, are politically unstable and their poppy acreage has grown at alarming rates. It is only a matter of time before the heroin from these countries will start trickling in.

There are no easy answers. Unlike cocaine, products made from the opium poppy are essential for the treatment of pain. There is little we can do to reduce access to heroin. We need to seriously relook at the present treatment infrastructure. Addiction treatment often is episodic, non-medical, punitive, expensive and ineffective. Few patients are sent home on medications like naltrexone to protect them from relapsing in the first days and weeks after rehab. Medications like naltrexone and Vivitrol that give patient a fighting chance of long-term recovery are rarely used.  

We are woefully unprepared to deal with the present situation and the bigger problems to come. One thing is certain: legalization of heroin is not the answer. Decriminalization and standardized treatment with non-opioid drugs can be.

Percy Menzies is the president of the Assisted Recovery Centers of America, a treatment center based in St Louis, Missouri. He is a passionate advocate of evidence-based medical treatment for addictive disorders.

He can be reached at: percymenzies@arcamidwest.com

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.

CDC: Fentanyl Urgent Public Health Problem

By Pat Anson, Editor

The Centers for Disease Control and Prevention is finally acknowledging that the U.S. has a fentanyl problem that is growing worse by the day. And that more people are dying in some states from overdoses of illicit fentanyl than from prescription opioids.

“An urgent, collaborative public health and law enforcement response is needed to address the increasing problem of IMF (illicitly manufactured fentanyl) and fentanyl deaths,” CDC researcher Matthew Gladden, PhD, said in the agency’s Morbidity and Mortality Weekly Report.  

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. It is prescribed legally in patches and lozenges to treat chronic pain, but in recent years there has been a surge in overdoses linked to illicit fentanyl obtained on the black market, where it is often mixed with heroin.

In a new analysis of opioid overdoses in 27 states, the CDC identified eight “high burden” states where fentanyl overdoses sharply increased, even though fentanyl prescriptions were relatively stable.

Those states are Massachusetts, Maine, New Hampshire, Ohio, Florida, Kentucky, Maryland and North Carolina.

In six of the eight states, the CDC said fentanyl was the “primary driver” of synthetic opioid deaths – meaning they outnumbered overdoses from legal synthetic opioids. That is a major concession by the agency, which has long maintained that prescription opioids were primarily responsible for the nation’s so-called opioid epidemic.

The data analyzed was from 2013 and 2014. More recent reports from several states indicate the fentanyl problem has significantly worsened. The DEA recently reported the U.S. is being “inundated” with counterfeit prescription drugs made with fentanyl.  

“This finding coupled with the strong correlation between fentanyl submissions (laboratory tests) and fentanyl-involved overdose deaths observed in Ohio and Florida and supported by this report likely indicate the problem of IMF is rapidly expanding,” Gladden wrote. “Recent (2016) seizures of large numbers of counterfeit pills containing IMF indicate that states where persons commonly use diverted prescription pills, including opioid pain relievers, might begin to experience increases in fentanyl deaths because many counterfeit pills are deceptively sold as and hard to distinguish from diverted opioid pain relievers.”

The CDC hasn’t been completely silent about the fentanyl problem. In October 2015 the agency issued a health advisory to public health departments, healthcare providers and medical examiners to be on the alert for fentanyl overdoses.  Warnings to the public, however, have been scarce as the agency focused instead on controversial guidelines that discourage doctors from prescribing opioids for chronic pain.

Even the U.S. Surgeon General appears to be neglecting the fentanyl problem. This week Surgeon General Vivek Murthy, MD, said he would be sending letters to over two million physicians urging them to follow the CDC guidelines and pledge to safely prescribe opioids. Nowhere in the letter or on a website promoting the “Turn the Tide” campaign is fentanyl even mentioned.  

Critics of opioid prescribing have long maintained that opioid pain medication is often a gateway drug to heroin and other illicit substances, but recent research indicates that is not true.

"Although the majority of current heroin users report having used prescription opioids non-medically before they initiated heroin use, heroin use among people who use prescription opioids for non-medical reasons is rare, and the transition to heroin use appears to occur at a low rate," researchers reported in the New England Journal of Medicine.

Another recent study of military veterans found there was no significant link between heroin use and legally prescribed opioids or chronic pain.

Further compounding the problem is that some heroin and fentanyl deaths are falsely reported as overdoses from opioid pain medication due to inadequate or nonexistent toxicology tests.

Prescribed Opioids Not Linked to Veterans’ Heroin Use

By Pat Anson, Editor

A new study of U.S. military veterans found a strong link between heroin use and the abuse of opioid pain medication, but with an important caveat:  the heroin use was associated with the non-medical use of opioid painkillers.

Having chronic pain was also not found to be a significant risk factor for heroin use.

The ten-year study by researchers at Brown and Yale Universities followed nearly 3,400 veterans at nine Veterans Affairs facilities who were participating in the Veterans Aging Cohort Study (VACS).

Of the 500 veterans who started using heroin during the study, 386 of them also began using prescription painkillers non-medically.

"Our findings demonstrate a pattern of transitioning from non-medical use of prescription opioids to heroin use that has only been demonstrated in select populations," said study co-author David Fiellin, a Yale public health and medical professor and director of the VACS study.

"Our findings are unique in that our sample of individuals consisted of patients who were receiving routine medical care for common medical conditions."

Even after statistically accounting for other risks -- such as race, income, use of other drugs, post-traumatic stress disorder (PTSD) and depression -- researchers found that veterans who began misusing painkillers were 5.4 times more likely to begin using heroin. Other major risk factors for heroin use include being male (2.6 times greater risk) and abusing stimulant drugs (2.1 times greater risk).

Veterans who received a short-term prescription for an opioid medication had a 1.7 times greater risk of starting heroin. But having a long-term prescription for opioids was not found to be a significant risk factor. And neither was having chronic pain.

“In our final model, pain interference in daily life was not a significant predictor of heroin initiation,” said lead author Brandon Marshall, an assistant professor in the Brown University School of Public Health.

Despite those findings, researchers recommend that all veterans should be screened for painkiller abuse, including those with legal prescriptions.

"This paper shows that, as a general clinical practice, particularly for this population which does experience a lot of chronic pain and other risks for substance use including PTSD, screening for non-medical painkiller use, whether you are prescribing an opioid or not, may be effective to prevent even more harmful transitions to heroin or other drugs," said Marshall, adding that veterans have a "constellation of risks" for substance abuse.

The study, published in the journal Addiction, did not identify the source of the opioids that were used non-medically. The National Institutes of Health and the U.S. Department of Veterans Affairs supported the study.

Under a federal spending bill passed by Congress and signed into law last year by President Obama, the Veteran’s Administration is required to follow the CDC's “voluntary” opioid guidelines, which discourage opioid prescribing for chronic pain. Since those guidelines were adopted, many veterans have complained to Pain News Network that their opioid doses have been reduced and they live in daily pain.

“They just cut my meds to one oxycodone every 12 hours, which gives me absolutely no relief,” wrote Harvey Williams, a Vietnam vet. “There must be something that the Veterans Administration can do to treat severe pain in the Vets. It's not fair for us to be sprayed with Agent Orange, return back to the United States, develop diabetes and in turn have severe neuropathy and pain for the rest of our lives and not be treated.”

“My VA doctors did not exam me prior to (cutting) my prescriptions,” wrote retired Army Capt. William Green, a Desert Storm veteran. “I asked how they decided to start reducing when I was reporting ongoing 6-8 on 10 pain scale. He didn't even consult with the doctor I do get ongoing treatment from. The doctor said, ‘We don’t care. We are following CDC guidelines.’”

The VA provides health services to 6 million veterans and their families. Over half of the veterans treated by the VA have chronic pain.   

‘Weird and Cool’ Discovery Could Lead to Safer Opioid

By Pat Anson, Editor

A “weird and cool” discovery by a team of international researchers could lead to the development of a new opioid medication that relieves pain without the risk of abuse and overdose.

In a case of reverse engineering, scientists in the U.S. and Germany deciphered the atomic structure of the brain’s mu-opioid receptor and then designed a drug – called PZM21 – that activates the receptor without the typical side effects of opioids. In experiments on mice, PZM21 did not cause drug-seeking behavior and did not interfere with breathing – the main cause of death in opioid overdoses.

“With traditional forms of drug discovery, you’re locked into a little chemical box,” said Brian Shoichet, PhD, a professor of pharmaceutical chemistry at UC San Francisco’s School of Pharmacy.

“But when you start with the structure of the receptor you want to target, you can throw all those constraints away. You’re empowered to imagine all sorts of things that you couldn’t even think about before.”

Shoichet and colleagues at Stanford University, the University of North Carolina and the Friedrich Alexander University in Erlangen, Germany published their findings in the journal Nature.

"This promising drug candidate was identified through an intensively cross-disciplinary, cross-continental combination of computer-based drug screening, medicinal chemistry, intuition and extensive preclinical testing," said Brian Kobilka, MD, a Nobel Prize winner and professor of molecular and cellular physiology at Stanford. It was Kobilka who first established the molecular structure of the opioid receptor.

Shoichet and his research team conducted roughly four trillion “virtual experiments” on UCSF computers, simulating how millions of different drug candidates could turn and twist in millions of different angles – called “molecular docking” -- to see how they fit into a pocket on the receptor and activate it. They avoided using molecules linked to the respiratory suppression and constipation typical of other opioids.

This led to the development of PZM21, which efficiently blocked pain in mice without producing the constipation and breathing suppression typical of other opioids. PZM21 also appears to dull pain by affecting opioid circuits in the brain only, with little effect on opioid receptors in the spinal cord. No other opioid has that effect, which Shoichet says is “unprecedented, weird and cool.”

The drug also didn’t produce the hyperactivity that other opioids trigger in mice by activating the brain’s dopamine systems. The mice did not display drug-seeking behavior by spending more time in chambers where they had previously received doses of PZM21.

“After we replicated the lab experiments and mouse studies several times, then I became excited about the potential of this new drug,” said Bryan Roth, MD, a professor of pharmacology and medicinal chemistry at University of North Carolina.

Researchers say more work is needed to establish that PZM21 is truly non-addictive, and to confirm that it is safe and effective in humans.

 “We haven’t shown this is truly non-addictive,” Shoichet cautioned. “At this point we’ve just shown that mice don’t appear motivated to seek out the drug.”

Listen to the Voices Silenced by Overdoses

By Judy Rummler, Guest Columnist

In reply to the recent article in Pain News Network about the Steve Rummler Hope Foundation, I want first of all to say that I have great compassion for those with chronic pain. 

My son Steve suffered from back pain for 15 years and many of the staff and volunteers of the Steve Rummler Hope Foundation have family members who have also suffered with chronic pain.  Sadly, many of us have lost our loved ones to opioid overdoses and we are working to prevent this from happening to other families. 

Had more cautious and responsible opioid prescribing practices been implemented before Steve died of an accidental overdose, he would have been terrified at the thought of losing access to his opioid pain medication.  He had developed the disease of addiction and had come to believe that his pills were the only solution for his chronic pain. 

Steve was a dean’s list student, all-conference soccer player and a gifted musician. He had many friends and a loving fiancée and family, yet he lost interest in almost everything that had once been important to him. 

He experienced the dilemma facing those who need treatment for both chronic pain and addiction.  Among his belongings we found a note describing his pills that said, “At first they were a lifeline; now they are a noose around my neck.” 

JUDY RUMMLER

It is important to remember that, while we can all hear the calls for relief from those who are suffering with chronic pain, we can no longer hear the 200,000 plus silenced voices of those who have died from opioid overdoses.  These people did not want to die and many of them would have lived if physicians had practiced more cautious and responsible prescribing.  Like most doctors, Steve’s doctor was well-intentioned but had received little training on the prescribing of opioids for pain.  

In an effort to provide this much-needed training, the Steve Rummler Hope Foundation has created a lecture series on “Pain, Opioids and Addiction” in partnership with the Minnesota Medical Association (MMA) and the University of Minnesota Medical School.  

These lectures are presented to medical students, videotaped and made available for continuing medical education (CME) at no cost on the MMA website.  The hope of the series is to create a medical curriculum on pain, opioids and addiction as it should be in a medical school setting: balanced, practical, evidence-based information free of commercial bias.

The mission of the Steve Rummler Hope Foundation is to heighten awareness of the dilemma of chronic pain and the disease of addiction, and to improve the associated care process.  We provide hope for those with chronic pain and addiction through our three programs: Overdose Prevention, Prescriber Education and Advocacy.  More information is available on our website.

Judy Rummler is a co-founder of the Steve Rummler Hope Foundation, a 501 (c) (3) non-profit organization based in Minnesota. The foundation recently became the fiscal sponsor of Physicians for Responsible Opioid Prescribing (PROP).

 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.

Study: Long Term Opioid Use Rare After Surgery

Pat Anson, Editor

It’s become a popular belief that many people become addicted to opioid pain medication after surgery. According to a recent national survey, one in ten pain patients believe they became addicted or dependent on opioids after they started taking them for post-operative pain.

But a large new study in Canada found that long term opioid use after surgery is extremely rare, with less than one percent of older adults still taking opioid pain medication a year after major elective surgery.

The study, published in the journal JAMA Surgery, looked at over 39,000 “opioid naïve” patients (no opioid prescriptions in the prior year) over age 65 who had a heart, lung, colon, prostate or hysterectomy surgery from 2003 to 2010.

One year after the surgery, only 168 of the surviving patients were still prescribed opioids – a rate of just 0.4 percent.

“Exposure to opioids is largely unavoidable after major surgery because they are routinely used to treat postoperative pain,” wrote lead author Hance Clarke, MD, Toronto Western Hospital.

In a previous study, Clarke and his colleagues looked at opioid use after major surgery and found that about 3% of patients were still taking opioids after three months. They decided to do this follow-up study to see how many were still being prescribed opioids 180 days, 270 days and 365 days after surgery. They found a steady decline in opioid use throughout the year.

“The estimate of 0.4% of patients continuing to receive opioids at 1 year is consistent with some limited available data,” Clarke wrote. “Our study thus provides reassurance that the individual risk of long-term opioid use in opioid-naive surgical patients is low.”

Earlier this year the American Pain Society (APS) released guidelines for postoperative pain care that encourage the use of non-opioid medications such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), gabapentin (Neurotin) and pregabalin (Lyrica).  The APS also said epidural injections could be used for pain relief during some surgeries.

A survey of over 1,200 pain patients by Pain News Network and the International Pain Foundation found that two-thirds of patients believe that non-opioid medication “did not help at all” in the hospital. Another 60 percent said their pain was not adequately controlled in the hospital after a surgery or treatment.

PROP Ends Affiliation with Phoenix House

By Pat Anson, Editor

Physicians for Responsible Opioid Prescribing (PROP), an influential and politically connected advocacy group that seeks to reduce opioid prescribing, is no longer directly affiliated with Phoenix House, which runs a nationwide chain of addiction treatment centers.

The Steve Rummler Hope Foundation is now the “fiscal sponsor” of PROP, which will allow PROP to collect tax deductible donations under the foundation’s 501 (c) (3) non-profit status. IRS regulations allow non-profits to form partnerships with like-minded organizations, allowing other groups to essentially piggyback off their non-profit status and collect donations.  

Like PROP, the foundation’s main goal is to reduce opioid prescribing. It is named after Steve Rummler, a Minnesota pain patient who became addicted to opioid medication while being treated for a back injury.

After several attempts at addiction treatment, Rummler relapsed and died of a heroin overdose at the age of 43.

“He struggled with the pain for a long time,” said Judy Rummler, Steve’s mother and chief financial officer of the foundation.  “He had what I think later was figured out to be some damage to the nervous system around his spinal cord because he had what he described as shooting electric shock-like sensations that would shoot up his back into his head and down his legs into his feet.”

Steve sought help from many doctors, but never received a treatable diagnosis. He started taking OxyContin for pain relief. 

“Once he was prescribed the opioids in 2005, then he didn’t care about getting answers anymore,” his mother said.

After Steve’s death in 2011, the Rummler family established the foundation with the goal of helping others who also struggle with chronic pain and addiction. It was PROP’s founder and chief executive, Andrew Kolodny, MD, who approached the foundation with the idea of joining forces.

“Basically as the fiscal sponsor we accept donations and we manage the funding. We don’t set any policy for him,” Judy Rummler told Pain News Network. “Obviously our missions are similar. We are very concerned about the overprescribing of opioids. Yet I know if my son were alive today he would probably be telling you what you hear from so many other pain patients; that he couldn’t live without them. But the problem was he died as a result of it.

“I know there are a lot of people who are going to be hurt by cutting back on the prescribing, but I just think a lot of them are addicted as my son was. Yet he would have been the first one to scream and yell about having his pills cutoff.”

The Rummler Foundation calls this tug-of-war between opioids and addiction “The Dilemma.” It advocates for wholesale change in the treatment of chronic pain, emphasizing “wellness rather than drugs” and the use of “a wide array of non-opioid options.”

Opioid medication should not be prescribed for chronic pain, according to Rummler.

“I would never say that it’s impossible for it to work for someone. I wouldn’t say that. But I would say there’s no evidence it would work. And it shouldn’t be prescribed that way,” she said.  “There are so many people dying. I hate to even use the term ‘abuse’ because I don’t think my son, really, I mean at the end he was an abuser, for sure. But it wasn’t abuse that got him addicted. It was the prescribing that got him addicted.”  

In addition to promoting awareness about opioid addiction, the Rummler Foundation sponsors prescriber education courses and provides free naloxone rescue kits to reverse the effects of opioid overdoses.

Links with PROP

The Rummler Foundation already has a lengthy association with PROP. Kolodny serves on the foundation’s medical advisory committee, as does Jane Ballantyne, MD, PROP’s president. The two groups have also participated together in several advocacy campaigns.

While PROP no longer considers itself “a program” of Phoenix House, Kolodny is still listed as the chief medical officer for the organization.

For several years, PROP lobbied the FDA, DEA and other federal agencies to reduce the prescribing of opioids with mixed success. Recently it played a significant role in the development of the CDC’s opioid guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. Kolodny, Ballantyne and three other PROP officers and board members served on panels advising the CDC.

As Pain News Network has reported, Ballantyne and two other PROP board members are currently participating in CDC funded webinars to teach prescribers how to implement the guidelines. Those guidelines, which were released in March, have already had a significant impact on the pain community. In a recent survey, over two-thirds of patients said their opioid medication has been reduced or stopped by their doctor. About half said they have considered suicide as a way to end their pain since the guidelines were released. 

In addition to his new affiliation with the Rummler Foundation, Kolodny is working with the Los Angeles-based Media Policy Center in developing a documentary on opioids and addiction. PROP is listed as one of the partners in the project, along with the Semel Institute of Neurobiology and the Geffen School of Medicine at UCLA.

The Media Policy Center (MPC), which declined to comment for this story, states on its website that it hopes to release the documentary in November and eventually air it on PBS.

“The best way to prevent deaths and overdose is through education,” MPC says in a statement on its GoFundMe campaign. “Many people have the misconception that opioids, such as OxyContin, are safe because they are prescription drugs, however, they are very addictive and once people lose access to their prescriptions or can no longer afford the drug they may turn to drugs like heroin.”

PNN has learned that several prominent doctors in the field of pain management have been approached to participate in a “debate” with Kolodny for the program. All have declined because they fear the documentary will be biased.

New Rule Expands Access to Buprenorphine

By Pat Anson, Editor

This week marks the start of a major expansion in access to buprenorphine – a medication that is both widely praised for treating opioid addiction and also blamed for fanning the flames of abuse and diversion.

The Department of Health and Human Services (HHS) updated a federal rule, nearly tripling the number patients that can be treated with buprenorphine by an eligible physician.

Raising the limit from 100 to 275 patients is intended to give addicts greater access to buprenorphine, especially in rural areas where few doctors are certified to prescribe the drug. According to HHS, over two million people who are dependent on heroin and other opioids could benefit from buprenorphine treatment.

“For too long, addiction specialists like me have had to turn patients in need away from treatment that might save their lives, not because we don’t have the expertise or capacity to treat them, but because of an arbitrary federal limit,” said Dr. Jeffrey Goldsmith, President of the American Society of Addiction Medicine .

But critics of the rule change say there will be a price to pay.

“Buprenorphine is one of the most abused pharmaceuticals in the world,” warns Percy Menzies, president of Assisted Recovery Centers of America, which operates four addiction treatment clinics in the St. Louis area.

“Sales of buprenorphine formulations have exceeded $2 billion a year, but we have not had any lessening of heroin addiction. Increased access to buprenorphine and increased availability of potent heroin and heroin laced drugs like fentanyl will only exacerbate the problem.”

The problem with buprenorphine is that it’s an opioid that can be used to treat pain or addiction. When combined with naloxone, buprenorphine reduces cravings for opioids and lowers the risk of abuse. For many years the drug was sold exclusively under the brand name Suboxone, but it is now produced by several different drug makers and is sold in tablets, sublingual films and even an implant.

Addicts long ago discovered that buprenorphine can also be used to get high or to ease their withdrawal pains from heroin and other opioids. Buprenorphine is such a popular street drug that the National Forensic Laboratory Information System ranked buprenorphine as the third most diverted opioid medication in the U.S. in 2014. 

“Too many physicians erroneously believe that naloxone in the formulation makes the drug safe,” Menzies said in an email to Pain News Network. “Increasing the limit is definitely going to increase diversion. The majority of the physicians prescribing buprenorphine do not provide any comprehensive relapse prevention counseling, random drug testing, etc. In the absence of standards for treating addictive disorders, anything goes and will be no different than treating chronic pain.

“We saw the problem with prescription opioids when opioids were promoted as safe and non-abusable in the treatment of chronic pain. Very quickly the numbers grew into the tens of millions and the addiction exploded. The unintended victims were the patients in genuine chronic pain.”

Menzies uses buprenorphine as an initial treatment for opioid addiction in his clinics, but prefers another medication -- naltrexone -- for long-term maintenance therapy. He says doctors who rely on buprenorphine exclusively will, in effect, be sentencing their patients to lifetime use of the drug.     

"Financial Opportunity" for Doctors

HHS acknowledges there could be “unintended negative consequences” to increased prescribing of buprenorphine. One is diversion. Another is an increase in patient volume, physician profits and buprenorphine “pill mills” – which are already popping up in states like Florida. Patients typically pay cash for buprenorphine at those clinics and receive little or no addiction counseling or services.  

“This proposed rule directly expands opportunities for physicians who currently treat or who may treat patients with buprenorphine,” HHS said in an extensive analysis of the rule change. “We believe that this may translate to a financial opportunity for these physicians.”

HHS estimates the cost of treating new buprenorphine patients at up to $313 million in the first year alone. Many of the patients are low-income and the bills for treating them – about $4,300 annually for each patient – will often be covered by Medicaid. The additional cost of treating these patients, according to HHS, will be offset by the health benefits achieved by getting addicts into treatment, which the agency generously estimates at $1.7 billion.

The Obama administration asked Congress for nearly $1 billion in additional funding to help pay for addiction treatment, but didn’t get it in when Congress passed the Comprehensive Addiction and Recovery Act (CARA Act). The President reluctantly signed the bill into law anyway.

A little noticed provision of the CARA Act is that it expands access to buprenorphine even further. Currently only a trained and certified physician can prescribe buprenorphine, but CARA requires HHS to update its rules within 18 months to allow nurse practitioners and physician assistants to prescribe buprenorphine, provided they undergo training first.

How can buprenorphine diversion be prevented when access to it is rapidly increasing?

One solution proposed by Menzies is to change the classification of buprenorphine from a Schedule III controlled substance to a Schedule II drug – the same classification change that hydrocodone went through in 2014. Such a move would limit buprenorphine prescriptions to an initial 90-day supply and require patients to see a doctor for a new prescription each time they need a refill.

“We are caught between a rock and a hard place. We need to increase access to buprenorphine and it will lead to increased diversion and abuse, and therefore I am recommending changing the schedule,” Menzies said in his email to PNN.

“This is the psychotic state of affairs! No chronic condition/disease/disorder has ever been successfully treated with an addicting drug and we think we can do it for opioid addiction!”

DEA: U.S. Facing ‘Fentanyl Crisis’

By Pat Anson, Editor

The United States is facing an unprecedented “fentanyl crisis” that is likely to grow worse as drug dealers ramp up production of counterfeit pain medication made with illicit fentanyl, according to a new report from the Drug Enforcement Administration.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. It is legally prescribed in patches and lozenges to treat severe chronic pain, but illicit fentanyl has recently emerged as a fast-growing scourge on the black market, where it is increasingly being used in the manufacture of counterfeit drugs.

“The counterfeit pills often closely resemble the authentic medications they were designed to mimic, and the presence of fentanyls is only detected upon laboratory analysis,” the DEA warns in the unclassified report.

“Fentanyls will continue to appear in counterfeit opioid medications and will likely appear in a variety of non-opiate drugs as traffickers seek to expand the market in search of higher profits. Overdoses and deaths from counterfeit drugs containing fentanyls will increase as users continue to inaccurately dose themselves with imitation medications.”

Dozens of Americans have died this year after ingesting counterfeit versions of oxycodone, Norco and Xanax, which are virtually indistinguishable from the real medications. Even a few milligrams of fentanyl can be fatal.

Tennessee bureau of investigation

The DEA said “hundreds of thousands of counterfeit prescription drugs” laced with fentanyl were on the market and predicted more would be produced because of heavy demand and the “enormous profit potential” of fake medication.

“The seizures of fentanyl-laced pills and clandestine pill press operations all across North America indicate that this is becoming a trend, not a series of isolated incidents,” the DEA said.

The report highlighted the fact that U.S. forensic laboratories tested over 13,000 seized drugs containing fentanyl in 2015, up sharply from less than a thousand cases two years earlier.

The DEA said counterfeit pills are being smuggled into the U.S. from Mexico and Canada. Traffickers usually purchase powdered fentanyl and pill presses from China, and pill press operations have recently been found in Los Angeles and New York.

The counterfeit drugs problem is so serious the DEA believes it is undermining efforts to limit opioid prescribing.

“The arrival of large amounts of counterfeit prescription drugs containing fentanyls on the market threatens to devalue such initiatives and replaces opioid medications taken off of the street,” the DEA said. “Although not all controlled prescription drug users eventually switch to heroin, fentanyl-laced pills give DTOs (drug trafficking organizations) broader access to the large controlled prescription drug user population, which is reliant upon diversion of legitimate pills. This could undermine positive results from the state Prescription Drug Monitoring Programs, as well as from legislative and law enforcement programs.”

As Pain News Network has reported, Massachusetts and Rhode Island recently said fentanyl was to blame for nearly 60 percent of their opioid overdose deaths.

Senators Urge DEA to Reduce Supply of Opioids

A group of U.S. Senators is urging the DEA to "aggressively combat the opioid epidemic," not by going after fentanyl traffickers, but by making legal opioids even harder to get.

In a letter to acting DEA administrator Chuck Rosenberg, Senators Dick Durbin (D-IL) Sherrod Brown (D-OH), Edward Markey (D-MA), Amy Klobuchar (D-MN), Angus King (I-ME), and Joe Manchin (D-WV) urged the agency to tighten its annual quotas for manufacturers to produce controlled substances.

"In effect, DEA serves as a gatekeeper for how many opioids are allowed to be legally sold every year in the United States. Yet, for the past two decades, DEA has approved significant increases in the aggregate volume of opioids allowed to be produced for sale," the letter states.

The Senators urged the agency to rollback a 25 percent increase in production quotas for Schedule II opioids that was implemented in 2013. Schedule II opioids include hydrocodone, a widely prescribed painkiller that was reclassified from a Schedule III to a Schedule II drug in 2014.

The Senators also said the DEA should make a mid-year adjustment in the quota to immediately reduce the supply of prescription opioids. The letter did not address the fentanyl crisis or the rapid growth in counterfeit medication.

Lower Back Pain Linked to More Drug Use

By Pat Anson, Editor

People with chronic lower back pain are more likely to have used illicit drugs -- including marijuana, cocaine, heroin and methamphetamine -- compared to those without back pain, according to new research published in the journal Spine.

The study also found that people with lower back pain who had used illicit drugs were somewhat more likely to have an active prescription for opioid pain medication (22.5% vs. 15%).

Lower back pain is the world’s leading cause of disability and most people will suffer from it at least once in their lives. Although nearly a quarter of the opioid prescriptions written in the U.S. are for low back pain, medical guidelines often recommend against it.

Researchers analyzed data from over 5,000 U.S. adults who participated in a nationally representative health study and found that nearly half (49%) of those who reported lower back pain admitted having a history of illicit drug use, compared to 43% of those without back pain.

Current use of illicit drugs (within the past 30 days) was much lower in both groups; 14% versus nine percent.

The study did not differentiate between recreational and medical marijuana use, nor did it draw a distinction between marijuana use in states where it is legal and where it is not. All marijuana use was considered "illicit."

All four illicit drugs in the survey were more commonly used by people with low back pain compared to those without back pain. Rates of lifetime use were 46.5% versus 42% for marijuana; 22% vs. 14% for cocaine; 9% vs. 5% for methamphetamine; and 5% vs. 2% for heroin.

Researchers said there was no evidence that illicit drug use causes lower back pain, only that there was an association between the two that bears watching when opioids are prescribed.

“The association between a history of illicit drug use and prescription opioid use in the cLBP (chronic lower back pain) population is consistent with previous studies, but may be confounded by other clinical conditions,” said lead author Anna Shmagel, MD, Division of Rheumatic and Autoimmune Diseases at the University of Minnesota.

“Mental health disorders, for example, have been associated with both illicit substance use and prescription opioid use in the chronic low back pain population. In the context of management, however, illicit drug abuse is predictive of aberrant prescription opioid behaviors. As we face a prescription opioid addiction epidemic, careful assessment of illicit drug use history may aid prescribing decisions.”

In a recent analysis of prescriptions filled for 12 million of its members, pharmacy benefit manager Prime Therapeutics found that nearly a quarter of the opioid prescriptions were written to treat low back pain.

"Our analysis found low back pain was the most common diagnosis among all members taking an opioid, even though medical guidelines suggest the risks are likely greater than the benefits for these individuals," said Catherine Starner, PharmD, lead health researcher for Prime Therapeutics.

In a 2014 position paper, the American Academy of Neurology said opioids provide “significant short term pain relief” for low back pain, but there was “no substantial evidence” that long term use outweighs the risk of addiction and overdose.

Doctor: Pain Has Never Killed Anyone

By John Hsu, MD, Guest Columnist

The opioid problem with medicine began when The Joint Commission promoted the concept that pain is the fifth vital sign, and that patients should be asked about their pain and the quality of their treatment.

Ten years ago, when my hospital was undergoing an inspection, I clearly remember the examiner chastising me about my multimodal pain therapy and her concern that it would leave patients in pain. Clearly, doctors were put on alert that they could be sued for leaving a patient in pain.

Pain as a fifth vital sign is really contraindicated. Pain has never killed anyone, but opioids killed over 29,000 Americans last year. They don’t have any vital signs.

Doctors are now at a crossroads. The Centers for Medicare and Medicaid (CMS) has attached patient satisfaction scores to reimbursement. A patient comes to the office and demands pain meds. If the doctor prescribes pain meds, the doctor can not only lose their license, but go to jail for murder, as Dr. Lisa Tseng from Rowland Heights, CA has. Or they can risk poor patient satisfaction scores and, if they are a part of an accountable care organization (ACO), risk losing their employment.

Why are doctors burned out? Because other people have come between the doctor-patient relationship. I had a nurse tell me that she would put her 21 years in ICU up to my skills as a physician, to which I retorted that she still had to take orders from me.

This loss of respect amid the loss of autonomy is frightening.  It is one of the major complaints doctors describe when they are asked about burnout and why they are leaving medicine. The healthcare team is no longer run by the doctor. It is run by nurses from the quality review department, enforcing best practices on physicians so protocols and guidelines set up by the government are followed.

I call that evidence-less based medicine. Guidelines have destroyed the doctor-patient relationship. Does the government really have patient interests at heart or is the government really just a big micromanager? 

Perhaps the answer to the opioid problem lies with outside-the-box thinking. What if we correctly promote that pain must be present for us to live and that some pain is good?  Unlike Patrick Henry, who said “Give me liberty or give me death,” I personally would prefer to say, "Give me pain and give me liberty, but don't give me death."

Patients have a responsibility to take care of their own health. All prescriptions written by doctors and filled by pharmacists were written correctly. Yet some patients are not compliant and take too many pills. We all know we should not overeat, but 70% of the American public is obese. Humans are their own worst enemies.  Unpopular as this stance may seem, it must be mentioned that while the population of the U.S. is 324 million, 259 million opioid prescription were written in in 2012. 

The Joint Commission's edict that no patient should be in pain changed patients' expectations. Everyone expected and demanded to be pain free. But focusing on the short term discomfort experienced by those in pain ignores the long term goal of improving a patient's health.

The government (FDA, DEA, CDC and policymakers) has decided to restrict opioid prescriptions. This is logical, but does not address human nature. The end result has been that addicts and patients who cannot get prescription opioids have turned to cheaper and easily attainable $5 bags of heroin. Heroin deaths have quadrupled in the last decade. In 2015, over 10,000 people died from heroin overdoses. The situation is rapidly worsening, as illicit drug makers are mixing heroin with fentanyl, which is 70 times stronger than morphine. 

The opioid conundrum has become readily apparent. Opioids may be the best treatment for pain, but they raise the risk of addiction, respiratory suppression, and death.

Cultural Shift Needed in Patient Education

The solutions needed for this dilemma include a cultural shift in the education physicians and nurses give to patients and the perception that pain is bad. We have to forsake the short term treatment of pain with opioids and look to the long term goal of preserving human life.

Let’s look at patient satisfaction scores and medical education. Studies show that when patient satisfaction scores are considered in prescribing care to patients, their care is not only more expensive, but often worse -- resulting in higher morbidity and mortality. Despite this evidence, CMS has connected patient satisfaction scores to hospital reimbursement. 

The Joint Commission has promoted an atmosphere where patients believe that they should never have to suffer pain and have the right to be “pain free.” More opioids were prescribed, but often patients demanded and even threatened doctors if they did obtain pain relief.  Doctors were accused of elder abuse and medical negligence if they did not prescribe pain medication, despite the lack of medical indications or consideration of narcotic alternatives. 

Fast forward a decade and suddenly the government realized that more addicts existed and more people were overdosing. Nearly 19,000 people died in 2014 from opioid prescription overdoses legally obtained from physicians and correctly filled by pharmacists.  The government ironically declared that doctors were to blame. 

The government could not blame patients for the problem, even though the general consensus is that patients were non-compliant with their prescribed opioid doses and shared their narcotics with family and friends.  Patients were not blamed for their actions because they vote and they reelect government officials. 

The government’s solution to the current opioid overdose epidemic was a policy change.  The FDA and CDC forced physicians to limit opioid prescriptions, and increased the difficulty of prescribing opioids by changing the scheduling of hydrocodone from Schedule III to Schedule II.  The government also began criminally prosecuting physicians for murder, even though the patient was noncompliant and overdosed on opioids. 

Why did the The Joint Commission, representing the federal government, have to get involved in medicine?  Why should a federal entity interfere with the doctor-patient relationship? It is not our fault that policies make us do certain things we believe are not in the best interest of the patient.

The Hippocratic Oath directs physicians to not allow outside influences effect their patient care decisions. I would like to see medicine practiced so that the government can no longer come between patients and their doctors. Let us amend the constitution so that there is a separation of medicine and state, just like the separation of church and state.  

JOHN HSU, MD

John Hsu, MD, has been practicing anesthesia at 600-bed hospital inCalifornia for the past 23 years.

Dr. Hsu recently founded MedRev Pharma, a pharmaceutical development company which is developing a safer opioid that minimizes the risk of abuse, addiction and respiratory depression.  Dr. Hsu is also the Director of SBS Medical Management, a consultation service that addresses issues relating to healthcare reform policies, physician practice management, and medical devices.

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.

DEA: ‘Hundreds of Thousands’ of Fake Pills in U.S.

By Pat Anson, Editor

A new report from the U.S. Drug Enforcement Association about the national threat posed by heroin may tell us more about another illegal opioid – fentanyl -- than it does about heroin.

The recently unclassified report, which you can read by clicking here, documents a stunning 248% increase in overdose deaths involving heroin from 2010 to 2014. Over 10,500 Americans died from heroin overdoses in 2014 alone.

But it turns out many of those deaths may have actually been caused by fentanyl, a synthetic opioid 50 to 100 times more potent than morphine. We’re not talking about pharmaceutical grade fentanyl legally prescribed in transdermal patches or lozenges to treat chronic pain, but bootleg white powder fentanyl manufactured in China and smuggled into the U.S.

The DEA says there were 5,544 deaths caused by fentanyl and other synthetic opioids in 2014, but admits “the true number is most likely higher.” The actual number is not known because many coroners and state crime laboratories do not test for fentanyl.

What medical examiners do often test for in suspected drug overdoses is heroin – and that is why the statistics on heroin should be taken with a grain of salt. Because the real culprit is often fentanyl.

“Most of the areas affected by the fentanyl overdoses are in the eastern United States, where white powder heroin is used,” the DEA report states. “Fentanyl is most commonly mixed with white powder heroin or is sold disguised as white powder heroin.”

Massachusetts and Rhode Island – two eastern states with big heroin problems – recently came out with reports showing that fentanyl, not heroin, was to blame for nearly 60 percent of their opioid overdose deaths. The states used toxicology tests that are far more accurate than the death certificate codes used by the DEA and the Centers for Disease Control and Prevention.  

The DEA and CDC overdose statistics are muddied even further by the fact that heroin deaths are “often undercounted” and blamed on morphine, a prescription painkiller.

“Many medical examiners are reluctant to characterize a death as heroin related,” the DEA admits. “Thus many heroin deaths are reported as morphine-related deaths. Further, there is no standardized system for reporting drug related deaths in the United States. The manner of collecting and reporting death data varies with each medical examiner and coroner.”

Why does any of this matter to chronic pain patients? Because deaths caused by fentanyl and heroin are being lumped together with overdoses caused by prescription painkillers. The CDC has been doing it for years to build a case against opioid pain medication and to justify its release of guidelines that discourage doctors from prescribing opioids for chronic pain.

Prescribing of opioid pain medication has been in decline for several years and hydrocodone prescriptions have fallen by 30 percent since 2011. Yet the CDC claims there was a sudden spike in opioid analgesic deaths in 2014 and that nearly 19,000 Americans died.

Some pain patients – no longer able to get opioids legally – are turning to the streets for pain relief. And the DEA report acknowledges that patients are now being targeted by drug dealers selling counterfeit medication.

“Hundreds of thousands of counterfeit prescriptions pills, some containing deadly amounts of fentanyl, have been introduced into U.S. drug markets, exacerbating the fentanyl and opioid crisis,” the DEA report says. “Motivated by enormous profit potential, traffickers are exploiting high consumer demand for prescription medications by producing inexpensive, fraudulent prescription pills containing fentanyl.

“The equipment and materials necessary to produce these counterfeit drugs are widely available online for a small initial investment, greatly reducing the barrier of entry into production for small-scale drug trafficking groups and individuals. In addition, fentanyl pill press operations have been identified in the United States, Canada, and Mexico, indicating a vast expansion of the traditional illicit fentanyl market.”  

The DEA says counterfeit medication caused at least 19 deaths this year in California and Florida. But, like the statistics for fentanyl and heroin, the actual number may never be known.   

When asked to comment on the DEA report, a spokesperson for the CDC told us that "the large distribution of pills seems to be a new threat that we are still assessing."