Researchers Identify Riskiest NSAIDs

By Pat Anson, Editor

The risk of non-steroidal anti-inflammatory drugs (NSAIDs) contributing to cardiovascular disease has been known for decades. But now we have a better idea which NSAIDs cause the most risk.

A large study published in the British Medical Journal found that use of any NSAID was associated with a 20 percent higher risk of being hospitalized with heart failure. Seven NSAIDs were found to be the riskiest, depending on the dose taken:

• diclofenac
• ibuprofen
• indomethacin
• ketorolac
• naproxen
• nimesulide
• piroxicam

In addition, two COX 2 inhibitors -- etoricoxib and rofecoxib – were also associated with a higher risk of heart failure.

“Our study, based on real world data on almost 10 million NSAIDs users from four European countries, provides evidence that current use of both COX 2 inhibitors and traditional individual NSAIDs are associated with increased risk of heart failure. Furthermore, the magnitude of the association varies between individual NSAIDs and according to the prescribed dose,” researchers reported.

The risk of heart failure doubled for people taking diclofenac, etoricoxib, indomethacin, piroxicam, or rofecoxib at very high doses. But even medium doses of indomethacin and etoricoxib were associated with increased risk. 

NSAIDs are used to alleviate pain and reduce inflammation, and are found in a wide variety of over-the-counter products – from headache relievers to cold and flu remedies. They are used in so many different products -- such as Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

An editorial in BMJ faulted the study for not going into more detail on the absolute risk between different NSAIDs.

“Information on absolute risks is valuable for clinicians and patients evaluating the balance between benefit and harm of treatment. Low risk patients might accept the small additional risk associated with treatment while higher risk patients might prefer to consider alternative treatments,” said Gunnar Gislason and Christian Torp-Pedersen, who are both professors of cardiology in Denmark.

“In some patients other pain treatments, such as paracetamol (acetaminophen) or a weak opiate, might be a good choice. For patients who do need NSAID treatment, it is important to consider the different risk profiles of the individual drugs. The selective COX 2 inhibitors and diclofenac have repeatedly been associated with higher cardiovascular risk, and therefore it seems prudent to avoid them and consider lower risk naproxen at the lowest effective dose.”

Several previous studies have found that NSAIDs increase the risk of cardiovascular disease and other health problems, but the exact cause has been unclear. A recent study at the University of California, Davis, found that NSAIDs reduced the activity of cardiac cells and led to cell death.

The European Society of Cardiology already recommends limited use of NSAIDs by patients who are at increased risk of heart failure. Those already diagnosed with heart failure should refrain from using NSAIDs completely.

Last year the U.S. Food and Drug Administration ordered warning labels for all NSAIDs to be strengthened to indicate they increase the risk of a fatal heart attack or stroke. The FDA said studies found the risk of serious side effects can occur in the first few weeks of using NSAIDs and could increase the longer people use the drugs. The revised warning does not apply to aspirin.

100 Million Pain Pills Unused After Dental Surgery

By Pat Anson, Editor

Over half the opioids prescribed to patients following dental surgery go unused, according to a small study by researchers who say the leftover pills could be abused or stolen by friends and family members.

Researchers affiliated with the University of Pennsylvania’s Perelman School of Medicine and School of Dental Medicine followed 79 patients who had their wisdom teeth removed or some other type of surgical tooth extraction. Seventy-two of them were given opioid pain medication after the surgery.

On average, patients received 28 opioid pills and – three weeks later -- had 15 pills (54%) leftover. Only five patients used all of the prescribed pills.

From that small sample, researchers project that as many as 100 million excess pain pills are prescribed annually by dentists.

 “When translated to the broad U.S. population, our findings suggest that more than 100 million opioid pills prescribed to patients following surgical removal of impacted wisdom teeth are not used, leaving the door open for possible abuse or misuse by patients, or their friends or family,” said lead author Brandon Maughan, MD, an emergency physician and health services researcher at The Lewin Group, a health policy consulting firm.

“Given the increasing concern about prescription opioid abuse in the United States, all prescribers – including physicians, oral surgeons and dental clinicians – have a responsibility to limit opioid exposure, to explain the risks of opioid misuse, and educate patients on proper drug disposal.”

Twenty-four hours after surgery, patients in the study reported an average pain score of 5 out of 10 while taking pain medication. By the second day, more than half (51%) reported a low pain score (0-3 out of 10), and by the fifth day, almost 80 percent had a low pain score.

“Results of our study show within five days of surgery, most patients are experiencing relatively little pain, and yet, most still had well over half of their opioid prescription left,” said co-author Elliot Hersh, DMD, a professor in the department of Oral & Maxillofacial Surgery and Pharmacology at Penn Dental Medicine.

“Research shows that prescription-strength NSAIDs, like ibuprofen, combined with acetaminophen, can offer more effective pain relief and fewer adverse effects than opioid-containing medications. While opioids can play a role in acute pain management after surgery, they should only be added in limited quantities for more severe pain.”

The study, published in the journal Drug and Alcohol Dependence, also found that drug disposal kiosks in pharmacies and small financial incentives may encourage patients to properly dispose of their unwanted pain medication.

Patients in the study received a debit card preloaded with $10. If they completed surveys assessing their pain and medication use after surgery, they received an addition $3 credit on the debit card. Patients who completed a follow-up health interview received an additional $10.

Patients were also provided with information about pharmacy based drug disposal programs, which led to a 22% increase in the number of patients who had either disposed or planned to properly dispose of their leftover opioids.

“Expanding the availability of drug disposal mechanisms to community locations that patients regularly visit – such as grocery stores and retail pharmacies – may substantially increase the use of these programs,” Maughan said.

Reducing the excess prescribing of opioids for acute pain is one of the goals of the Centers for Disease Control and Prevention. The CDC's prescribing guidelines state that three days or less supply of opioids “often will be sufficient” for acute pain caused by trauma or surgery, and that 7 days supply “will rarely be needed.”  Those guidelines, however, were developed for primary care physicians, not dentists.

Survey: Kratom ‘Very Effective’ for Chronic Pain

By Pat Anson, Editor

Chronic pain sufferers often struggle to find a treatment that works. Opioids dull the pain, but come with the risk of addiction; drugs like Lyrica and Cymbalta can have unwelcome side effects; over-the-counter pain relievers often don’t work for severe pain; and alternative treatments like massage and acupuncture are not always covered by insurance.

So people experiment and try different things – often settling for something that just takes the edge off their pain.

That brings us to kratom, an herbal supplement largely unknown to most pain patients and their doctors. At a recent pain management conference attended by thousands of practitioners, I could find only a handful of doctors who’d even heard of kratom. I’ll confess I didn’t know much about it myself until a few months ago.

Maybe we should all start paying more attention.

In an online survey of 6,150 kratom consumers by Pain News Network and the American Kratom Association, nine out of ten said the herb was a “very effective” treatment for pain, depression, anxiety, insomnia, opioid addiction and alcoholism.

Less than one percent said it did not help.

This was not a scientific study by any means on the safety and efficacy of kratom. It was an online survey of self-selected kratom consumers, many of them quite upset that the U.S. Drug Enforcement Administration is planning to make the sale and possession of kratom illegal, perhaps as soon as the end of the month.

In a 21-page notice published in the Federal Register, the DEA said kratom does not have "an approved medical use” and “is misused to self-treat chronic pain.”

WAS KRATOM EFFECTIVE IN TREATING YOUR PAIN OR MEDICAL CONDITION?

The agency cited no studies to support its claim that kratom was being “misused” to treat pain, so we decided to ask the people who actually use it:

"Honestly, I was blown away at how good it was for my pain and also had the benefit that it lifted my mood, which was important because of the depression I had been experiencing from the chronic pain."

"This natural approach to pain management has allowed me to work full time as a school teacher and be an actively involved mom. These are things I never thought I would be able to have in my life as a result of debilitating pain from a neurological condition for which there is no medical cure."

"I have acute chronic migraines that, unmedicated, result in pain that is completely debilitating, and at times have landed me in the emergency room with stroke symptoms. Multiple doctors have okayed my use of kratom for pain management, as over-the-counter medicine simply does not work and I cannot take opiates."

"My wife has fibromyalgia and has taken kratom for more than 12 years with no adverse effects. Prior to finding kratom, she had tried all of the medication that was prescribed to her. The prescription medication either didn't work, or the side effects outweighed the benefits. Kratom has been a godsend for my wife and has allowed her to function as a mother of 4 children for more than a decade."

"I have been living with chronic pain from multiple reconstructive foot surgeries for 20+ years. Kratom not only effectively treats my pain, but it enabled me to tell my doctor that I no longer wanted my monthly tramadol prescription."

What pain conditions does kratom work best on? Again, this is not a scientific study, and we don’t have a lot of data for certain conditions. For example, 100% of the people who used kratom for cancer pain said it was “very effective” for them, but we only had 27 respondents who identified cancer as the primary reason they used kratom.

On the flip side, over 1,700 respondents said they used kratom for back pain, so the data is probably more reliable for them. And 92% said kratom was very effective for back pain.  

Percentage Who Rated Kratom “Very Effective” for their Pain Condition

powdered kratom

• 100% Cancer
•   97% Multiple Sclerosis
•   94% Irritable Bowel Syndrome
•   93% Migraine
•   93% Fibromyalgia
•   92% Rheumatoid Arthritis
•   92% Back pain
•   92% Acute Pain
•   91% Lupus and other autoimmune diseases
•   90% Osteoarthritis
•   90% Neuropathy
•   88% Trigeminal Neuralgia
•   79% RSD or CRPS
•   76% Ehlers Danlos syndrome   

Quite a few people said they use kratom for pain conditions we didn’t ask about or discovered that it helped them feel better in unexpected ways:

"I tried kratom for many things and it has worked for all. Toothaches, back and knee pain, sore joints and ligaments, flu symptoms, and insomnia."

"I have had very little back pain since I starting taking kratom to treat it. Three side effects I didn't expect is that it eliminated my restless leg syndrome, reduced my blood pressure to a normal level and significantly reduced my overall cholesterol levels."

"I have found so much relief for my ulcerative colitis and carpal tunnel syndrome from this plant that I fear how my body will respond when I no longer have it."

"I use kratom for severe TMJ disorder and sacroiliac joint dysfunction. I am also a recovering addict, and kratom has helped me stay clean and be the best 4th grade teacher I can be. If I hadn't had kratom to help ease chronic pain and the urge to use, I wouldn't be doing my dream job. I'd probably be in jail without a job, divorced, and possibly even dead."

"Kratom without a doubt helps any part of my body to not be in pain. Not only does it help with pain, it helps with my depression and it helps me get to sleep very easily."

Many also have strong feelings about allowing drug companies to use kratom in pharmaceutical products, which would require approval from the Food and Drug Administration. 

Seven out of ten kratom consumers are opposed to that idea, believing drug makers have conspired with the DEA to make kratom illegal.

"This is big pharma using the DEA to eliminate an all-natural herb that is taking a bite out of their drug selling profits."

"Everyone knows all this has to do with the DEA and big pharma being in each other’s back pockets. Money is the root of all evil and here it shows again."

"I feel that the pharmaceutical companies are behind this. People are weaning themselves from their addictions and those that don't end up overdosing requiring Narcan. That is a lot of money they stand to lose."

"If pharmaceutical companies produce kratom, the cost will probably triple. There will be tremendous red tape in even getting the drug from a doctor."

SHOULD DRUG MAKERS BE ALLOWED TO PRODUCE AND MARKET KRATOM?

To see the complete survey results, click here.

Meanwhile, lobbying efforts continue by the American Kratom Association to get the DEA to postpone its decision to classify the two active ingredients in kratom as controlled substances. Two congressmen, Rep. Mark Pocan (D-Wisconsin) and Rep. Matt Salmon (R-Arizona) are circulating a letter on Capitol Hill urging the DEA to delay enacting its order.

“We hope to see a lot of congressmen and women sign onto this,” says Susan Ash, founder of the American Kratom Association. “The letter asks that the director of the Office of Management and Budget and the acting director of the DEA delay a final decision on the placement of kratom as a Schedule I substance, provide ample time for public comment on this significant decision, and resolve any other inconsistencies with other federal agencies.”

A similar letter is being prepared by a law firm hired by the American Kratom Association. Ash told PNN it’s possible the DEA will not formally act on the scheduling of kratom until well after September 30.   

“When we’ve looked back at some of the other emergency scheduling processes that have happened, we have found that they will say it’s going to happen in 30 days, but it’s usually a few weeks after that. That’s just what’s happened historically. We don’t think September 30 is essentially a firm date, just based on history, but we are prepared in case it is.”

Ash said her organization would seek a restraining order from a judge if the emergency scheduling is implemented by DEA.

Kratom Users Say Ban Will Lead to More Drug Abuse

By Pat Anson, Editor

Kratom is a safe and surprisingly effective treatment for chronic pain and a wide variety of medical conditions, according to a large new survey of kratom consumers. Many say banning the herbal supplement will only lead to more drug abuse and worsen the nation’s opioid epidemic.

The online survey of 6,150 kratom consumers by Pain News Network and the American Kratom Association was conducted after plans were announced by the U.S. Drug Enforcement Administration to classify two chemicals in kratom as a Schedule I controlled substances. Unless the scheduling is postponed, the sale and possession of kratom could become a felony as early as September 30.

The survey findings dispel the myth that kratom is used recreationally like marijuana by people who only want to get “high” or intoxicated. The vast majority say they use the herb in teas and supplements solely to treat their medical conditions.

Asked what was the primary reason they used kratom, over half (51%) said they used the herb as a treatment for chronic pain, followed by anxiety (14%), depression (9%), opioid addiction (9%) and alcoholism (3%). Less than two percent said they used kratom recreationally or out of curiosity.

WHAT IS THE PRIMARY REASON YOU USE KRATOM?

“The survey tells us exactly what we’ve been trying to tell the DEA, lawmakers and the general public. The average kratom consumer is nothing like we are being portrayed as,” says Susan Ash, founder of the American Kratom Association.

“The average kratom consumer is a man or woman in their 40’s, 50’s or 60’s, who is primarily looking for alternatives to pharmaceutical drugs that either didn’t work for them or had side effects that were unbearable. The survey clearly shows the majority of people are using kratom to manage chronic medical conditions.”

Nine out of ten patients (90%) said kratom was very effective in treating their pain or medical conditions.

Asked if they get high from using kratom, three out of four consumers (75%) said no and 23% said “a little.” Only about 2 percent said they get high from using the herb. Many likened the stimulative effect of kratom to a strong cup of coffee.

"I only take enough kratom to take the edge off. I never get high like I did on pills or marijuana. Just a clearer state of being with some pain relief."

"It's not possible to get high from kratom as that's not what it does. It is in the same family as coffee and acts just like coffee."

"It elevates my mood, gives me energy and helps with the pain."

"I was stable at all times with kratom. Sound minded and alert. In no negative way did it affect my ability to function. If anything, it improved that and my overall happiness in life."

CAN YOU GET "HIGH" FROM KRATOM?

While the DEA maintains that kratom poses “an imminent hazard to public safety” and has been linked to several deaths, the vast majority of kratom consumers believe it is safe to use.

Ninety-eight percent said kratom was not a harmful or dangerous substance and 95% said banning the herb will have a harmful effect on society.

Many have strong feelings about what will happen if kratom is made illegal.

"I believe this is incredibly harmful to the thousands of people who have been able to find relief from a huge variety of issues, but especially those treating an opioid addiction. Those people will be forced back to opiates."

"I believe that the ban on kratom will trigger the biggest uptick in opiate-related deaths that we've seen in decades."

"Banning kratom will in no way protect society from an imminent health hazard, but actually push society further into the deadly opiate epidemic that plagues America today."

"It will kill people if they make kratom Illegal."

"We must utilize every tool possible to combat addiction to dangerous drugs, and banning kratom is like cutting off your nose to spite the face: stupid and unproductive."

WILL BANNING KRATOM BE HELPFUL OR HARMFUL TO SOCIETY?

Given a variety of scenarios on what could happen if kratom becomes illegal, two out of three respondents (66%) said kratom consumer would be more likely to become addicted and overdose on other substances.

Over half (52%) predicted that kratom users would be more likely turn to illegal drugs such as heroin and illicit fentanyl.

Half (51%) also said kratom consumers would be more likely to consider suicide.

Asked what they would do personally if kratom is banned, one out of four (27%) said they would seek to buy kratom on the black market – indicating that many are willing to risk being charged with a felony rather than give up kratom. Less than a third (30%) said they would not buy kratom on the black market.

"Making kratom illegal isn't going to stop people from buying and taking kratom."

"People who want kratom bad enough will find it and keep using it."

"I believe kratom consumers are likely to try multiple strategies, but most likely they will go back to whatever they used prior to kratom and there will likely be a black market for illegal consumption because none of these other options can compete with the efficacy of kratom."

"We will all be forced to go back on the very drugs that kratom helped us get off of! It will kill a whole lot of people! It will undoubtedly cause an increase in suicides, overdoses of illegal drugs like heroin and morphine."

"Banning this leaf is equivocal to signing the death certificates of many. You may as well be sticking the needle into many arms."

IF KRATOM BECOMES ILLEGAL, WOULD YOU SEEK TO BUY IT ON THE BLACK MARKET?

Susan Ash of the American Kratom Assocation estimates that between 3 and 5 million Americans have tried kratom. And she thinks the DEA’s attempt to ban the herb may have actually led more people to try it.

“Probably a quarter of a million have tried it since they put this notice out,” Ash said.

To see the complete survey results, click here.

Click here to see a report on the effectiveness of kratom in treating specific chronic pain conditions such as fibromyalgia, migraines and back pain.

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.

Half of Patients Have Trouble Getting Pain Meds

By Pat Anson, Editor

A new survey of chronic pain patients found that over half – 56 percent -- have experienced problems getting access to opioid pain medication, either from a pharmacy or their own doctor. Nearly half of the patients surveyed also said they have contemplated suicide.

“Access continues to be a problem and a growing problem for patients living with chronic pain,” said Jeff Dayno, MD, chief medical officer for Egalet, a pharmaceutical company that conducted the survey along with the American Chronic Pain Association (ACPA).

The online survey of over 1,000 patients was conducted in 2015, before guidelines were issued by the Centers for Disease Control and Prevention that discourage primary care physician from prescribing opioids for chronic pain. Although the guidelines are voluntary, they’ve had a chilling effect on many doctors and pharmacists since their release in March.  

“General practitioners who don’t have as much experience are having somewhat of a knee jerk reaction. Either they’re not prescribing opioids at all or taking a very cautious approach,” said Dayno.

“The broader medical community is backing away from the more effective type of pain medications and opioids specifically, even at the pharmacy level in terms of stocking them and having them available.”

Nearly two-thirds of patients (63%) said their pharmacy carries only a limited supply of pain medication. And nearly four out of ten patients (39%) said their physician no longer prescribes pain medication.

“Since the push to combat prescription medication abuse has risen, so have the number of calls we have received from individuals expressing their frustration about accessing their prescription medications,” said Penney Cowan, founder of the ACPA. “The study found that access really is an issue for individuals; they struggle to find doctors who are willing to treat them, and pharmacies that stock their medication.

“For individuals living with chronic pain, access to medication is vital to functioning in their everyday lives. Doctors would not withhold prescriptions from patients with other medical conditions such as diabetes or heart disease. What’s startling is the high percentage of individuals who have contemplated suicide.”

Forty-seven percent of the survey respondents said they’ve had thoughts of suicide.

“The statistic around patients contemplating suicide, we’ve seen numbers like that in the literature before. And that’s a very concerning and frightening aspect of the impact of limited access to effective pain medications,” said Dayno, who believes the number of patients complaining about access would be even higher if the survey was conducted today.

When asked by Pain News Network if he thought the CDC even considered suicides and other negative consequences on patients when it was drafting the guidelines, Dayno said no.

“I don’t think that dimension was clearly considered in the guidelines. I think it was much more of an evidence based, clinical approach on the pain management side. But the impact of potential barriers to access to these medications was not factored in to that assessment as part of the CDC guidelines,” he said.

A noted expert on pain management says he’s also seen “anecdotal reports” of primary care physicians and pain management specialists dumping pain patients since the CDC guidelines came out.

“I think some doctors are increasingly uncomfortable with continuing to prescribe what has been a higher dose of opioids, uncomfortable with the scrutiny that they’ve gotten, and as a consequence they are discharging patients from clinics, urging them to find care elsewhere,” said Sean Mackey, MD, Chief of the Division of Pain Medicine at Stanford University.

Kratom Petition Reaches Goal, But Now What?

By Pat Anson, Editor

Supporters of a citizens' petition that calls on the Obama administration to reverse a decision that will make the sale and possession of kratom illegal have reached their goal of 100,000 signatures.

But the move is largely symbolic and will probably not prevent the Drug Enforcement Administration from classifying kratom as a Schedule I controlled substance at the end of the month.

The DEA filed notice in the federal register last week for an emergency scheduling of mitragynine and 7-hydroxymitragynine, the two main active ingredients in kratom, which comes from the leaves of a tree that grows in southeast Asia.

Kratom is used in teas and supplements as a natural treatment for pain, depression, anxiety and other medical conditions. The DEA claims kratom is also used recreationally for its "psychoactive effects" and has even been used as a substitute for heroin. Kratom supporters say its no stronger than a cup of coffee.

Under its "We the People" petition rules, the Obama Administration promises to "take action" on an issue whenever supporters are able to gather at least 100,000 signatures online within 30 days.

"We will do our best to respond to petitions that cross the signature threshold within 60 days, however, depending on the topic and the overall volume of petitions from We the People, responses may be delayed," the White House says in a statement on its website.

According to the website whpetitions.info, the average response time for a successful petition is 118 days. Six petitions -- including the kratom petition -- are currently waiting for a response.

Barring a last minute legal challenge, the DEA scheduling of kratom as a controlled substance, alongside heroin, LSD and marijuana, will begin September 30.

"This may go into effect before we get a response from the White House," says Susan Ash, founder of the American Kratom Association, a volunteer organization of kratom users. "That's one of the reasons why we are doing our rally September 13th in front of the White House, so that we can bring this issue to their attention prior to them being required to give us a response."

The Obama administration began hosting "We the People" petitions on the White House website in 2011. Although the petitions have been criticized as a public relations gimmick, some have resulted in federal action, such as legislation allowing consumers to use their mobile devices on any network they choose.

At other times, however, the White House response to a petition has been a statement that only reaffirms current policy. That was the case in 2011, when petitioners asked the administration to legalize marijuana.

"Like many, we are interested in the potential marijuana may have in providing relief to individuals diagnosed with certain serious illnesses," wrote Gil Kerlikowske, Director of the Office of National Drug Control Policy, in the official White House response to the petition.

"That is why we ardently support ongoing research into determining what components of the marijuana plant can be used as medicine. To date, however, neither the FDA nor the Institute of Medicine have found smoked marijuana to meet the modern standard for safe or effective medicine for any condition."

The DEA is taking a similar stance on kratom, saying it has no medically accepted use.

Should the DEA Ban Kratom? Take Our Survey

By Pat Anson, Editor

A natural supplement that most Americans are not familiar with is suddenly being thrust into the national spotlight and debate over opioid addiction.

Nearly 70,000 people have signed a White House petition and many are planning to attend a rally next week in Washington DC to protest plans by the DEA to classify a kratom as an illegal narcotic.

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries as a natural medicine. Only in recent years has kratom caught on in the United States – where the leaves are used in teas and supplements to treat pain, depression, anxiety and even addiction.

Since the DEA’s surprise decision was announced, many kratom supporters have written us saying that kratom is far more effective and safer than pharmaceutical drugs.

“I was amazed at the pain relief, energy, anxiety relief, and mood boost that it gave me,” wrote Connie Fuller, a high school teacher and mother of two who suffers from arthritis, fibromyalgia, back pain and other chronic conditions. “I still feel pain 24/7 but it’s quite tolerable most days and I gladly smile again. We MUST keep kratom legal so that I can keep my life.”

“I'm a kratom user of two years and my life has dramatically improved. I'm so scared about this. Not sure what I'm going to do. I don't want to be on pharmaceuticals again. But I don't want to be a criminal either,” said Jordan.

Is kratom really the “hazard to public safety” that the DEA says it is? Does it make people high? Where is the evidence that it actually works?

In an effort to answer some of these questions, Pain News Network has partnered with the American Kratom Association in an online survey to see why people use kratom, whether it is effective, and what they plan on doing if the sale and possession of kratom is criminalized by the DEA.  

(Update: The survey is now closed. The results will be released September 20)

“The CDC, DEA and other federal agencies, as well as the media, believe that we are nothing but a bunch of teenagers or young adults who are only using kratom on a recreational basis and are abusing it,” says Susan Ash, who founded the American Kratom Association. “That is simply not the case. Our members are largely people in their 40’s, 50’s and 60’s. We have a lot of soccer moms, firefighters, lawyers and lobbyists who are members. To paint a truer picture of the kind of people that are using this product medicinally, this survey will be helpful in showing that we’re not the kind of people that they think we are.”

The DEA notice published in the Federal Register last week will classify the two main active ingredients in kratom -- mitragynine and 7-hydroxymitragynine -- as Schedule I controlled substances, the same classification used for heroin, LSD and marijuana.

Although mitragynine and 7-hydroxymitragynine are alkaloids, the DEA took the unusual step of calling them “opioid substances,” even though they don’t originate from the poppy plant like other opioid pain medications. The DEA saidkratom has “a high potential for abuse” and was linked to several deaths.

“In the United States, kratom is misused to self-treat chronic pain and opioid withdrawal symptoms, with users reporting its effects to be comparable to prescription opioids. Users have also reported dose-dependent psychoactive effects to include euphoria, simultaneous stimulation and relaxation, analgesia, vivid dreams, and sedation,”  the DEA said.

“They did that on purpose,” says Ash. “They put ‘opioid’ in there to get sympathy from all of the Congress people already working on this issue, who will look at that Federal Register notice and say ‘Oh my God, another opioid.’ We need to ban it.”   

Another unusual aspect of the DEA action is that there was no public notice or comment period, as there usually is when a controlled substance is scheduled. It will become illegal to possess or sell mitragynine and 7-hydroxymitragynine – in other words, kratom itself – at the end of September.

“This emergency scheduling only gives people 30 days to come up with a solution. Most people can’t even get in to see their doctors in 30 days,” says Ash. “They’re putting tens of thousands of people in a position where they have to decide 'Do I go back to pharmaceuticals?' and 'Do I even have time to see my doctor?'

“We’re leaving people completely in the lurch that count on kratom for their health and well-being. People have been using kratom safely for years and these people are basically being told you need to cut off your use abruptly.”

Ash says the American Kratom Association is meeting with lawyers to pursue every possible legal avenue to stop or delay the DEA's scheduling process. She’s also hopeful that grassroots action, the rally in Washington, and the results of our survey will help educate the public and media about kratom’s benefits.  

FDA Expands Warning Labels on Opioids & Sedatives

By Pat Anson, Editor

The U.S. Food and Drug Administration is expanding the warning labels on all opioids and benzodiazepines – a class of anti-anxiety sedative that includes Xanax – because of the serious risk of overdose and death when the drugs are used together.

The FDA’s “black box” warning labels – the FDA's strongest warning – involve nearly 400 opioid analgesics, opioid-containing cough products, benzodiazepines and other central nervous system (CNS) depressants.  The risks associated with using the drugs simultaneously are fairly well-established and include extreme sleepiness, respiratory depression, coma and death.

The agency said the move is one of a number of steps the FDA is taking as part of its Opioids Action Plan, which is focused on policies “aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective and appropriate pain management.”

"It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together," said FDA Commissioner Robert Califf, MD. "We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or CNS depressants more generally – together outweigh these serious risks."

In addition to benzodiazepines, other CNS depressants include sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and alcohol.

The new warning labels caution physicians to prescribe benzodiazepines or other CNS depressants “at the lowest effective dose” if a patient is already taking an opioid.  

The FDA said the number of patients who were prescribed both an opioid analgesic and benzodiazepine increased by 41 percent between 2002 and 2014, which translates to an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines.

From 2004 to 2011, the rate of emergency department visits involving non-medical use of both drug classes increased significantly, with overdose deaths involving the drugs nearly tripling.

Recent guidelines by the Centers for Disease Control and Prevention also urge doctors to use caution when co-prescribing opioids and benzodiazepines.

The prescribing of opioid pain medication in the U.S. has actually been in decline for several years, but the number of overdoses blamed on opioids – both legal and illegal – continue to rise. One explanation for that is that the co-prescribing of opioids and sedatives has not changed.

According to a 2015 study, over a third of the patients prescribed opioids for chronic musculoskeletal pain were given a sedative. And patients with a history of psychiatric and substance abuse disorders were even more likely to be co-prescribed opioids and sedatives.

In February 2016, the FDA received a citizen petition from the city of Baltimore and over 40 public health officials asking the agency to strengthen warning labels for opioids, sedatives and depressants. The FDA said it was already reviewing data on the simultaneous use of the drugs, but today’s action was a response to that citizen petition.

Animal Studies Show Promise for Safer Opioids

By Pat Anson, Editor

Animal studies currently underway could hold the key to developing new opioid therapies that relieve pain without the risk of addiction, overdose and other harmful side effects.

Researchers at Wake Forest Baptist Medical Center in North Carolina have developed a pain killing compound -- called BU08028 – that relieves pain in monkeys without causing physical dependence. BU08028 is similar to buprenorphine, an opioid currently used to treat both pain and addiction.

"Based on our research, this compound has almost zero abuse potential and provides safe and effective pain relief," said Mei-Chuan Ko, Ph.D., professor of physiology and pharmacology at Wake Forest Baptist and lead author of the study published in the Proceedings of the National Academy of Sciences.

"This is a breakthrough for opioid medicinal chemistry that we hope in the future will translate into new and safer, non-addictive pain medications."

This study, which was conducted on 12 monkeys, targeted a combination of mu opioid receptors in the brain – the same receptors targeted in humans by existing opioid pain medication.

The Wake Forest researchers examined behavioral, physiological and pharmacologic factors and found that BU08028 blocked pain signals without the side effects of respiratory depression, itching or adverse cardiovascular events. In addition, the study showed pain relief lasted up to 30 hours in the monkeys and repeated administration did not appear to cause physical dependence.

"To our knowledge, this is the only opioid-related analgesic with such a long duration of action in non-human primates," said Ko. “Given the decades-long effort aimed at developing abuse-free opioid analgesics, BU08028 represents a major breakthrough for opioid medicinal chemistry.”

Ko plans further animal studies on related compounds to see if they have the same safety profiles as BU08028. If those studies are successful, he hopes to begin studies on humans with the ultimate goal of getting FDA approval for a new class of opioid medication.

The research is funded by the National Institutes of Health and National Institute on Drug Abuse.

Rat Study Targets Peripheral Nerves

Another animal study is taking a different approach to pain relief – by targeting nerves in peripheral tissue – not the mu opioid receptors in the brain and spinal cord.

In findings published in Cell Reports, researchers at the University of Texas found that targeting delta opioid receptors on sensory neurons in the peripheral tissue of laboratory rats produces fewer side effects and with much lower abuse potential.

"Being able to increase the responsiveness of peripheral opioid receptor systems could lead to a reduction in systemic opioid administration, thereby reducing the incidence of side effects," says senior study author Nathaniel Jeske of the University of Texas Health Science Center at San Antonio.

One complication is that delta opioid receptors in peripheral tissues only become activated in the presence of inflammation. Because it has not been clear how to overcome this need for an inflammation trigger, the development of drugs that target peripheral nerves has been limited.

Jeske and his colleagues discovered a protein called GRK2 that binds to and prevents delta opioid receptors on rat sensory neurons from responding normally to opioids. But when those peripheral nerves were exposed to a natural inflammatory molecule called bradykinin, GRK2 moved away from the delta opioid receptors, setting off a biochemical reaction that restored the functioning of these receptors.

In addition, rats with reduced GRK2 levels in peripheral sensory neurons regained sensitivity to the pain-relieving effects of a drug that activates delta opioid receptors, and without the need for an inflammatory trigger.

The researchers hope to replicate the same findings using human tissues.

"By shedding light on how inflammation activates delta opioid receptors, this research could potentially lead to the development of safer, more effective opioids for the treatment of pain," said Jeske, whose work is funded by the National Institutes of Health.

Did Untreated Pain Lead Veteran to Commit Suicide?

By Pat Anson, Editor

Two congressmen are asking for an investigation into the apparent suicide of a Navy veteran suffering from chronic back pain outside a veteran’s hospital in New York.

76-year old Peter Kaisen of Islip was found dead inside his car in a parking lot Sunday at the Veterans Affairs Medical Center in Northport. He suffered a fatal gunshot wound to the head.

Kaisen’s wife told Newsday that he suffered from back pain and was unable to sit for more than a few minutes. She said doctors at the VA hospital told her husband there was nothing more they could do to ease his suffering.

The VA this year implemented the Centers for Disease Control and Prevention’s opioid guidelines, which discourage doctors from prescribing opioid pain medication for chronic pain. Since those guidelines were adopted, several veterans have complained to Pain News Network that their opioid doses have been reduced or stopped altogether. It's not clear if that's what happened to Kaisen.

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

A longtime friend and fellow veteran told the Associated Press that Kaisen visited the VA hospital once or twice a month. He lives about 30 miles away.

"We all think there is probably some depression," said Tom Farley said. "Maybe he wanted meds. Maybe he wanted to sit and talk. I don't know. None of the family knows."

A spokesman for the hospital declined to discuss Kaisen's medical history, but said the hospital had no evidence that he sought treatment at the emergency room on the day he died.

"The Northport VA stands ready to cooperate with any investigative body that believes more information is needed," the hospital's director, Philip Moschitta, said in a statement. "At no point did the staff in this facility fail to do the right thing by our patients."

PETER KAIsEN

But two hospital employees told The New York Times that Kaisen had been frustrated he could not see a doctor in the emergency room, where he went to seek help related to his mental health.

“He went to the E.R. and was denied service,” one employee said. “And then he went to his car and shot himself."

“Someone dropped the ball. They should not have turned him away,” another worker said.

Congressmen Peter King and Steve Israel sent a letter to the FBI and the Department of Veterans Affairs on Thursday asking for a "transparent" investigation into Kaisen’s death.

"It is critical that our nation's veterans feel they can trust the services provided by their VA medical facilities, and that their health and wellbeing is of the upmost priority," they wrote.

Kaisen’s wife told Newsday her husband served on a Navy supply ship, the USS Denebola, from 1958 to 1962.

According to a 2014 Inspector General’s study, more than half of the veterans being treated at the VA have chronic pain, as well as other conditions that contribute to it, such as post-traumatic stress disorder.

Because veterans are at high risk of opioid abuse and overdose, the VA implemented an Opioid Safety Initiative in 2013 to discourage its doctors from prescribing the drugs. The number of veterans prescribed opioids fell by 110,000, but alarms were raised when some vets turned to street drugs or suicide to stop their pain.

According to a VA study released in July, an average of 22 veterans commit suicide each day.

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.

Surgeon General Launches Anti-Opioid Campaign

By Pat Anson, Editor

U.S. Surgeon General Vivek Murthy, MD, has partnered with two non-profit health organizations in an ambitious and unusual campaign against the abuse of prescription opioids.

Murthy is taking the unprecedented step of sending a letter to 2.3 million physicians and prescribers, asking them to take a pledge to “turn the tide” against opioid abuse. Included in the letter is a “pocket card” that summarizes guidelines released by the Centers for Disease Control and Prevention, which discourage primary care physicians from prescribing opioids for chronic pain.

“Years from now, I want us to look back and know that, in the face of a crisis that threatened our nation, it was our profession that stepped up and led the way. I know we can succeed because health care is more than an occupation to us. It is a calling rooted in empathy, science, and service to humanity,” Murthy says in the letter.

The two-page pocket card generally follows the CDC guidelines, stating that opioids only provide short-term benefits for moderate to severe pain and that "scientific evidence is lacking" for opioids to treat chronic pain.

“In general, do not prescribe opioids as the first-line treatment for chronic pain,” the pocket card states.

The card also urges physicians to prescribe no more than a 3-day supply of opioids for acute pain and to “avoid” prescribing doses of more than 90 mg (morphine equivalent) a day. 

surgeon general vivek murthy, MD

To take the pledge, physicians are asked to visit TurnTheTideRx.org and promise to educate themselves about treating pain safely and effectively; to screen patients for “opioid use disorder” and provide them access to treatment; and to talk about addiction “as a chronic illness, not a moral failing.”  

Physicians are also asked to give their full names, zip code and an email address to “stay connected” with the Turn The Tide campaign. The website was created in partnership with Public Health Foundation Enterprises and the Institute for Healthcare Improvement.

“The Surgeon General realized that in order to raise awareness and reach people in all communities, he wanted to partner with non-profits that were in the public health space to help advance the messaging around the opioid crisis in the United States,” said Blayne Cutler, MD, president and CEO of Public Health Foundation Enterprises. 

“We thought it was a very important campaign because the data surrounding opioid addiction in this country has been very concerning and worsening over time. This is one of the few areas in public health where we see the number going in the wrong direction.”

No Mention of Fentanyl Crisis

Murthy's letter and the website focus exclusively on prescription opioids and don’t even mention opioid overdoses caused by heroin or the surge in illicit fentanyl deaths now sweeping the country, which the DEA has called an unprecedented crisis. Some states have reported over half of their overdoses are now caused by fentanyl.

In explaining the omission, Cutler said Murthy wanted to focus on how people are introduced to opioids and how they become addicted.

“He’s taking a broad look at how prescribers are thinking about opioids in the context of their patients and what can we do to make sure we effectively treat pain and also make sure we are doing no harm in that process. So it’s a tricky balance,” Cutler told Pain News Network.

“Blaming prescription opioid prescribing for all the overdoses is not going to help solve the problem,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “Of course every unintentional or accidental overdose is a tragedy beyond belief but so are the suicides by people who have been told they can no longer receive opioids for their pain.  

“Why do we ignore the people in pain? Most overdoses are not people recently prescribed an opioid. It is very harmful to send a message to providers that doesn't reflect the honest crisis that exists.” 

Webster says he receives an email nearly every day from a pain patient crying for help because a physician has already taken them off opioids or lowered their dose.

“Dr. Murthy will worsen this crisis with his letter,” Webster said in an email to PNN. “Abandonment is not humane. I know he is well intended but he obviously doesn't understand the crisis.”

EpiPen Price Scandal Overshadows Opioid Tax

By Pat Anson, Editor

The high cost of prescription drugs has been a hot topic this year for many Americans struggling to pay the soaring cost of healthcare. But a scandal over the price of a lifesaving medication provides a lesson on how tangled money, family and politics can get -– and how low the price of opioid painkillers ranks on the totem pole of public outrage.

The scandal involves the CEO of Mylan Pharmaceuticals -- who happens to be the daughter of a U.S. senator – whose financial compensation has ballooned right alongside the inflated price of the EpiPen, a drug injector that reverses allergic reactions to things like peanuts and bee stings.

According to NBC News, Mylan CEO Heather Bresch took home nearly $19 million in salary, stock and other compensation last year, amounting to almost a 700% raise over eight years.

During the same time period, Mylan jacked up the price of the EpiPen by over 400%. The pocket sized injector that sold for $56 in 2007 now costs $317 wholesale.

sen. joe manchin

Bresch is the daughter of West Virginia Senator Joe Manchin (D), perhaps the biggest critic of opioid prescribing in Congress, who has alleged that pharmaceutical companies that make opioids have too cozy a relationship with the Food and Drug Administration.   

According to OpenSecrets.org, Manchin has accepted over $127,000 in campaign contributions from donors affiliated with Mylan, making the company the senator’s second largest corporate contributor. Mylan makes a wide variety of pharmaceutical products, including opioids.

There is no indication Manchin has ever acted on behalf of Mylan while in Congress, but his daughter’s involvement in the EpiPen scandal has created an embarrassing situation for the senator with many colleagues, including fellow Democrats.

"I demand that Mylan take immediate action to lower the price of EpiPen's for all Americans that rely on this product for their health and safety," Connecticut Sen. Richard Blumenthal (D) wrote this week in a letter to Bresch. “My office has been contacted by dozens of concerned Connecticut residents, families, school nurses, and first responders who urgently require your life-saving product but fear that its skyrocketing price has put it out of reach.”

“This outrageous increase in the price of EpiPens is occurring at the same time that Mylan Pharmaceutical is exploiting a monopoly market advantage that has fallen into its lap,” chimed in Sen. Amy Klobuchar (D), who called for a federal investigation of Mylan.

“Patients all over the U.S. rely on these products, including my own daughter. Not only should the Judiciary Committee hold a hearing, the Federal Trade Commission should investigate these price increases immediately,” Klobuchar said in a press release that claimed the Minnesota senator has “championed efforts to address the high cost of prescription drugs.”

Klobuchar’s concern about the cost of prescription drugs only goes so far. She is co-sponsoring legislation with Sen. Manchin that would establish a tax on all opioid pain medication.

If approved, it would be the first federal tax on a prescription drug levied directly on consumers.  Eight other senators are sponsoring the Budgeting for Opioid Addiction Treatment Act, also known as the LifeBoat Act, which would raise an estimated $2 billion annually to fund addiction treatment programs.

Democratic presidential nominee Hillary Clinton is another fan of Manchin’s opioid tax. In May, during a roundtable discussion about opioid overdoses in West Virginia, Clinton called the tax “a great idea” and said it was “one of the reasons why I am such an admirer of Sen. Manchin.”

Raising prices on opioids is one thing, but hiking the cost of EpiPens is apparently another. Today Clinton called the injector price hikes “outrageous” and “the latest troubling example of a company taking advantage of its consumers.”

Several weeks ago Pain News Network asked the Donald Trump campaign where the Republican nominee stood on the opioid tax. We have yet to get a response.

EpiPen Heather Bresch's "Baby"

Sen. Manchin has been in tangled situations before involving his daughter. In 2007, the Pittsburgh Post Gazette reported that West Virginia University bent the rules to give Heather Bresch a master’s degree in business administration – even though she had only completed about half the credits needed to earn it.

There is no indication that Manchin, who was then West Virginia’s governor, pulled any strings for his daughter, but the resulting scandal led to the resignation of several school officials and Bresch’s MBA degree was revoked.

That didn’t stop Mylan from promoting her to chief operating officer, then president, and now CEO.

Manchin was further embarrassed when Mylan took advantage of a tax loophole and moved much of the company's business to the Netherlands, where there are lower taxes and Dutch law made it easier to fend off a hostile takeover from a rival drug maker. Manchin told The National Journal that what his daughter did should be illegal.

Manchin has not commented publicly about the EpiPen pricing scandal, which Bresch played a major role in starting.  According to STAT, Bresch called the EpiPen her "baby" and spearheaded efforts to widen its use.

heather bresch

Mylan spent tens of millions of dollars in lobbying and advertising efforts that culminated in passage of a federal law that gives preferential treatment to schools that stockpile EpiPen injectors.  Sales of the EpiPen soared as a result and so did its price, even though the amount of epinephrine – the generic drug inside the injector – is only worth about $1 according to Bloomberg.

The EpiPen now generates $1.2 billion in sales for Mylan, which issued a long statement that vaguely blamed the injector’s soaring price on “changes in the healthcare insurance landscape.”

“This current and ongoing shift has presented new challenges for consumers, and now they are bearing more of the cost. This new change to the industry is not an easy challenge to address, but we recognize the need and are committed to working with customers and payors to find solutions to meet the needs of the patients and families we serve,” the company said.

The EpiPen scandal has enraged so many people that a MoveOn.org petition, called Stop Immoral Price Gouging for Life-Saving EpiPen, had garnered over 150,000 signatures.

Meanwhile, a petition drive aimed at scuttling the opioid tax has drawn a little over 1,600 signatures.