How the Opioid Crisis Has Changed

By Roger Chriss, Columnist

The CDC recently released its first annual “Surveillance Report of Drug-Related Risks and Outcomes,” a lengthy and data filled study that documents the changing nature of the opioid crisis. Much attention is paid to declining rates of opioid prescribing, rising rates of heroin and fentanyl overdoses, and the increasing number of multiple or “poly-drug” overdoses.

According to the report, efforts to rein in opioid prescribing have succeeded in ways that are often not recognized:

• Opioid prescriptions fell 4.9% each year between 2012 and 2016.
• High-dose opioid prescriptions (above 90 MME) dropped 9.3% annually from 2009 to 2016.
• In 2016, there were 66.5 opioid prescriptions per 100 persons, down from 72.4 opioid prescriptions per 100 persons in 2006.

Much of this decline came before the release of the 2016 CDC opioid guidelines and subsequent efforts by state governments, health insurers, and drug store chains like CVS to reduce prescribing.

In 2016, opioid prescribing in the U.S. was at about three times the level of 1999 -- still high, but  down from the peak of four times the 1999 level. At the current rate of reduction, we will reach twice the 1999 level sometime next year and be back to 1999 levels by early 2021 at the latest. Ongoing moves by regulators and insurers to reduce opioid prescribing may accelerate this process.

Clearly, as the report states and many pain patients already know, healthcare providers are “becoming more cautious in their opioid prescribing practices.”

Tragically, similar success is lacking in the overdose crisis.

In 2015, the most recent year covered in the report, 52,404 people died of drug overdoses. About 63% of those deaths involved an illicit or prescription opioid, with heroin being the most common cause in 12,989 deaths. The other 37% of deaths involved non-opioids such as cocaine and methamphetamines. Over 5,000 deaths were identified as suicides and nearly 3,000 were identified as having undetermined intent.

The CDC report estimates that about 2 million people are addicted to prescription opioids and nearly 600,000 Americans are addicted to heroin. These numbers have remained largely unchanged since 2012, meaning that there has been little if any progress in preventing opioid addiction.

Limits on opioid prescribing have also not resulted in fewer deaths. Overdose fatalities are still rising sharply, mostly because of heroin and illicit fentanyl.

"Prescription opioid pain relievers were formerly driving the crisis, but by 2015 they shared equal measure with heroin, synthetic opioids other than methadone (mostly illicit fentanyl), and – increasingly-- cocaine and methamphetamines,” the report found.

In the two years since 2015, the final year for overdose data in the report, drug deaths have spiked higher. In 2016 there were 63,632 fatal overdoses and the early analysis for 2017 suggests the numbers are even worse. The handful of states that are seeing a decrease in drug deaths are attributing it largely to the increased use of naloxone to revive overdose victims.

Also alarming is that in 2015, around 33 percent of heroin users had initiated use with that drug rather than with opioid analgesics or some other substance. And heroin, illicit fentanyl, and virtually every other drug are now readily available on darknet markets.

At present, overdose rates are rising for virtually every major class of drug. The only class of drug that has seen a drop is prescription opioids.  

The opioid crisis is real, though as the CDC report shows, it is fast becoming an overdose crisis driven primarily by more potent and risky street drugs. Opioid medication is just one of many substances involved and its role is decreasing.

The CDC report concludes ominously: “Additional measures are now urgently needed to address a diverse and evolving array of drug types.”

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

4 P’s That Can Help Lower Pain Levels

By Barby Ingle, Columnist

Having lived with chronic pain for 21 years -- with diagnoses such as arthritis, TMJ disorder, endometriosis, hypothyroid, ischemia, seizures, reflex sympathetic dystrophy (RSD) and thoracic outlet syndrome -- I know what life with a chronic condition is like.

I have tried many different treatment options, yet still have not found “the cure.” That doesn’t mean I have stopped looking. As part of my continuing alphabet series on alternative pain treatments, this month I am covering 4 P’s of pain management: physical therapy, pain medications, prolotherapy and psychology. 

Physical Therapy

Also known as PT and physiotherapy, physical therapy uses movement through manual therapy, exercise, and electro-therapy to improve range of motion, mobility, function and daily living.

Used incorrectly, physical therapy can be harmful. It is very important to get a physical therapist that understands your health condition, knows when to push you and when to hold you back, and can teach you exercises you can learn to do independently.

A good physical therapist will do research on your condition and help educate you about your body’s limits and potential for improvement. They will also be in regular contact with your doctor and other healthcare providers.

Due to insurance practices in the United States, the number of physical therapy sessions is often limited and rarely lasts throughout a chronic illness. But many of the techniques can be continued at home on the patient’s time, once they learn how to do them properly.

When I first started physical therapy, I did all of the wrong exercises because my therapist didn’t know or understand the conditions I have. My mentality at the time was no pain no gain, so we both over-worked me. It made things far worse than if had I done nothing in the first place.

Once I was with the right physical therapist, I began to see improvements in my daily function. We learned together it wasn’t about pushing my limits, but more about working as a team to find ways around the physical limitations I had.

Pain Medication

When the average person hears the words “pain medication” they often think about opioids. But there are a many different types of pain medication available, including medical cannabis, NSAIDs, benzodiazepines, tricyclic antidepressants, alcohol, kratom, cox-2 inhibitors, and muscle relaxers.

Based on my speaking with medical professionals and researchers, I believe that all options -- including opioids -- should be on the table when a provider is deciding what is best for the patient.

I have heard from thousands of patients (of the millions who use opioids daily) who swear by two things. First, they have no other treatment option due to access or cost.  Second, there is no other treatment option that works as well as opioid medication.

I know that the evidence is weak on the long-term use of opioids. Every test, assessment and research study can be torn apart by opioid critics. But for me, it all comes down to this: If I have something that helps me function better and live a better quality of life, I want to have access to it. I have lost many friends to suicide due to uncontrolled pain and a few to addiction.

Opioids are not typically the first line of treatment. More and more, due to insurance company policies, guidelines and legislation, pain patients will get acetaminophen or NSAIDs, or be given nerve blocks, spinal injections or some other invasive procedure. Opioid medications are far less prescribed than they used to be. And many patients can’t get them at all.

Doctors are now being taught in medical school that what they prescribe should be determined by the type of pain someone has. For neuropathic pain, they are taught that traditional analgesics are less effective. Therefore, many providers will prescribe tricyclic antidepressants and anticonvulsants for nerve pain. And they will use topical NSAIDs creams and ointments for muscle sprains and overuse injuries.

Prolotherapy

Prolotherapy is an injection-based treatment used for pain conditions that involve musculoskeletal disorders, such as low back pain, tendonitis and knee osteoarthritis.

The injection is typically administered where joints and tendons connect to bone.  In theory, the injection creates an irritation to the injured area that helps stimulate healing. This technique that has been practiced since Roman times, when they used hot needles on gladiator injuries to promote healing.

Patients may report mild pain and irritation at the injection site, which usually goes away within 72 hours. They also may report numbness or minor bleeding right after the injection. There have been cases of disc and spinal injuries reported.

I used to hear a lot about prolotherapy 10-15 years ago, but I hear less and less about it now, as it is not typically used to treat nerve diseases. It is also not well reimbursed by insurance companies and Medicare has decided not to cover prolotherapy injections for low back pain at all.

Psychology

Psychology is used to help prevent the reliving of psychological distress or dysfunction, and to promote positive thoughts, well-being and personal skills. Psychology should not to be confused with psychiatry, which is the medical specialty devoted to the diagnosis, prevention and treatment of mental disorders.

I have undergone psychological counseling in both group and individual settings over the years. The time when I found it most helpful was before I finally got a proper diagnosis of RSD and started infusion therapy. At the time, I was beginning to feel like a guinea pig. Some providers didn’t know what to do with me and having a psychologist providing support and making sure my mental attributes were strong was very helpful. 

I still use some of the mindfulness techniques he taught me to this day. When I was getting ready for infusion therapy, I felt like I had tried every treatment available on earth. Having a professional psychologist to speak with and go over what happens if the infusion didn’t work prepared me for a worst-case outcome.

Luckily, I didn’t need it, but it did teach me that even though I felt like I had tried everything, there are always new options being created and that I had not actually tried everything.

This is one of the reasons I am so sure that the alternative treatments I have been presenting over the last 8 months are helpful to others. I never realized until I did the research that there are so many different things to try. Using a multi-modal approach to pain and understanding that the mind, body and spirit connection are real is important not to neglect.

There were times when my providers suggested that I go to a psychologist, and other times when I had to get psychological clearance for different procedures. I found that when I went to a session, I felt better about myself. It was "me time" -- a time to focus on getting through the depression and anxiety of living with a chronic illness.

I learned that chronic pain affects our brains and causes depression and anxiety, and that it was not the other way around. That there are tools and medications to address them, and that knowing myself and what is going on with my health was one of the best ways to get past the depression and anxiety.

Psychologists gave me aptitude tests to check my general knowledge, verbal skills, memory, attention, reasoning, and perception. A few also gave me personality and neuropsychological tests. The more I learned about myself, the better I was able to navigate through chronic illness, the people around me, and the better relationships I was able to achieve.

I once again look forward to reading your comments. What treatments have you tried, what has worked, and what didn’t work? What tips do you have to pass on to other readers? Have you found the treatment protocol that works for you?

I personally don’t believe that there is a magic pill or procedure that can cure chronic pain - yet. I also strongly believe that the patient and their providers should be making the decisions for what is best for the patient.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website. 

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

Should Gabapentin Be a Controlled Substance?

By Pat Anson, Editor

The U.S. Drug Enforcement Administration should consider scheduling gabapentin (Neurontin) as a controlled substance, according to researchers who studied the recreational use of the drug in Kentucky.

Gabapentin is a nerve medication approved by the Food and Drug Administration to treat epilepsy and post-herpetic neuralgia (shingles), but it is also widely prescribed off-label to treat fibromyalgia, migraines, neuropathy and other chronic pain conditions. The Centers for Disease Control and Prevention even recommends gabapentin as a safer alternative to opioids.

Sales of gabapentin have soared in recent years. About 64 million prescriptions were written for gabapentin in the U.S. in 20l6, a 49% increase in just five years.

But drug abusers have also discovered that gabapentin can heighten the effects of heroin, marijuana, cocaine and other substances.

"People are looking for other drugs to substitute for opioids, and gabapentin has filled that place for some," said Rachel Vickers Smith, PhD, an assistant professor at the University of Louisville School of Nursing. “Some have said it gives them a high similar to opioids. It had been easy to get a prescription for gabapentin and it's very cheap."

Vickers Smith and her colleagues recruited 33 people from Appalachian Kentucky who used gabapentin recreationally and asked them about their drug use. Many reported they started taking gabapentin over 10 years earlier for a legitimate medical condition, such as pain and anxiety. Over time, they started using the drug to help them relax, sleep and get high.

“Focus group responses highlighted the low cost of gabapentin for the purpose of getting high and noted increasing popularity in the community, particularly over the last 2 years. Gabapentin was a prominent drug of abuse in two cohorts of the primarily opioid-using individuals. Providers should be aware of gabapentin’s abuse potential, and a reexamination of the need for scheduling is warranted,” researchers reported in the journal Psychology of Addictive Behaviors.

In 2017, Kentucky became the first state to classify gabapentin as a controlled substance, which makes it more difficult for the medication to be prescribed. Ohio’s Substance Abuse Monitoring Network also issued an alert warning of gabapentin misuse across the state.

‘Snake Oil of the 20th Century’

Gabapentin was first approved by the FDA in 1993 and sold by Pfizer under the brand name Neurontin. A few years later, it was so widely prescribed that a top Pfizer executive called gabapentin “the snake oil of the twentieth century” in an email. The company was later fined hundreds of millions of dollars for promoting Neurontin’s off-label use.

"Early on, it was assumed to have no abuse potential," says Vickers Smith. "There's a need to examine it in further detail, especially if prescribing it is going to be encouraged."

Federal health officials have only recently started looking into the misuse and abuse of gabapentinoids, a class of nerve medication that includes gabapentin and pregabalin (Lyrica).

"Our preliminary findings show that abuse of gabapentinoids doesn't yet appear to be widespread, but use continues to increase, especially for gabapentin," FDA commissioner Scott Gottlieb, MD, said last week at a conference on opioid prescribing. "We're concerned that abuse and misuse of these drugs may result in serious adverse events such as respiratory depression and death. We want to understand changes in how patients are using these medications."

Gottlieb said FDA investigators are looking at websites and social media where opioid users discuss their use of gabapentinoids.

"We know we need to investigate and respond to signs of abuse as soon as signals emerge. We need to get ahead of these problems," he said.

Gabapentin is not currently scheduled as a controlled substance by the DEA, while Lyrica is classified as a Schedule V controlled substance, meaning it has a low potential for addiction and abuse.  

Getting the Story Right About Opioids

By Pat Anson, Editor

Many chronic pain patients feel they are wrongly portrayed in the media as malingerers and addicts – and that the growing difficulty they have just getting their pain treated is being ignored by the medical profession.

There’s a fair amount of truth to that.

Which is why two recent articles in Politico and The New England Journal of Medicine – both written by doctors – are worth highlighting for PNN readers. They help dispel many of the myths about pain patients and the role they played in the so-called opioid epidemic.

“As an addiction psychiatrist, I have watched with serious concern as the opioid crisis has escalated in the United States over the past several years, and overdose deaths have skyrocketed,” Sally Satel, MD, wrote in Politico. “I have also watched a false narrative about this crisis blossom into conventional wisdom: The myth that the epidemic is driven by patients becoming addicted to doctor-prescribed opioids, or painkillers like hydrocodone.”

Dr. Satel practices at a methadone clinic, lectures at the Yale University School of Medicine and is a resident scholar at the American Enterprise Institute, a conservative think tank.  She has also done her homework about the opioid crisis, recognizing that the nation’s growing scourge of overdose deaths is “overwhelmingly attributable” not to prescription opioids, but to illegal ones like heroin and illicit fentanyl.

Satel also acknowledges that opioid prescriptions in the U.S. have been declining for years and that only a small percentage of pain patients become addicted. Yet insurers, pharmacies and regulators continue to tighten access to opioid medication, and anti-opioid activists rant about pain patients getting hooked after taking a few “heroin pills.”

“We must be realistic about who is getting in trouble with opioid pain medications. Contrary to popular belief, it is rarely the people for whom they are prescribed. Most lives do not come undone, let alone end in overdose, after analgesia for a broken leg or a trip to the dentist,” Satel wrote.

“We need to make good use of what we know about the role that prescription opioids plays in the larger crisis: that the dominant narrative about pain treatment being a major pathway to addiction is wrong, and that an agenda heavily weighted toward pill control is not enough.”

That narrative clearly has been harmful to patients. Satel cites a PNN survey of over 3,000 patients, which found that over 70% were no longer prescribed opioids or had their dose cutback after the CDC’s opioid prescribing guidelines were released in 2016.  Nine out of ten patients said the guidelines had worsened the quality of pain care in the United States, and 60 percent said it had become harder or impossible for them to find a doctor willing to treat their pain.

The Story of Mr. P

Patient abandonment and the growing lack of access to pain treatment is presented in the story of “Mr. P” – as told in the NEJM by Drs. George Comerci, Joanna Katzman and Daniel Duhigg, who are colleagues at a pain clinic in Albuquerque, New Mexico. Mr. P was prescribed opioid medication for two years when his doctor adopted a no-opioids policy in his practice.

“Mr. P. was given a prescription for a month’s worth of oxycodone and advised to find another prescriber in the future.  Not unexpectedly, six other physicians refused to prescribe him opioids, and he ended up in our pain clinic, sobbing in the exam room, terrified that he’d end up ‘back in my old life’ if he had to buy his pain medications on the street,” the doctors wrote.

“In the past year, our university-based interdisciplinary pain clinic has seen a flood of cases like Mr. P.’s. The increase in opioid-related mortality fueled by injudicious prescribing and increasing illicit use of both prescription and illegal opioids has led some clinicians to simplify their lives by discontinuing prescribing of opioid analgesics. The fallout is a growing pool of patients who are forced to navigate their transition off prescribed opioids, often with little or no assistance or guidance, with the potential for disastrous results.”

What is happening to these abandoned patients who can’t find adequate treatment?

“We fear that an injudicious approach involving blanket refusals to prescribe opioids and adoption of unreasonable prescribing and dispensing regulations will increase patient suffering. Furthermore, the worst-case scenario is for patients to obtain prescription opioids illegally and eventually transition to more dangerous drugs, such as heroin,” the doctors warned.

The opioid crisis continues to spiral out of control. Government efforts to intimidate doctors and dictate prescribing levels are not only harming patients, they may be making things worse. A recent report from the CDC found that illicit fentanyl – not prescription pain medication -- was responsible for over half the overdoses in ten states.

As Dr. Satel points out, if we ever hope to fix the problem and find the right solutions, we need to stop focusing on patients and doctors.

“We cannot rely on doctors or pill control policies alone to be able to fix the opioid crisis. What we need is a demand-side policy. Interventions that seek to reduce the desire to use drugs, be they painkillers or illicit opioids, deserve vastly more political will and federal funding than they have received,” she wrote. “If we are to devise sound solutions to this overdose epidemic, we must understand and acknowledge this truth about its nature.”

FDA Recalls Three Kratom Brands

By Pat Anson, Editor

The U.S. Food and Drug Administration Wednesday announced the recall of three brands of dietary supplements containing kratom, the latest move in what appears to be a concerted government campaign to stop all sales of the herb.

The recall involves a large volume of kratom supplements sold under the brand names Botany Bay, Enhance Your Life and Divinity, which are manufactured and sold nationwide by Divinity Products Distribution of Missouri. The FDA said the company had agreed to the “voluntary destruction” of its kratom products, even though there have been no reports of illnesses associated with them.

“The company has also agreed to stop selling all products containing kratom. Based on the scientific evidence of the serious risks associated with the use of kratom, in the interest of public health, the FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take similar steps to take their products off the market,” the FDA said in a statement.

The move appears unrelated to Tuesday’s warning from the CDC linking kratom to a Salmonella bacteria outbreak in 20 states. The CDC said 8 of the 28 people who were sickened by Salmonella had recently used kratom, making it the "likely source." No actual bacteria was found in a kratom product.

In recent months, the FDA has released a public health advisory warning that kratom should not be marketed as a treatment for opioid addiction, chronic pain, depression or any other medical condition. The agency also released a computer analysis that found kratom contains over two dozen opioid-like substances.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death. At the same time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

“To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products. We appreciate the cooperation of companies currently marketing any kratom product for human consumption to take swift action to remove these products from circulation to protect the public.” 

'No Question They Want to Ban It’

“We’re in for a fight,” said David Herman, president of the American Kratom Association, a pro-kratom consumer group. “This is clearly a disinformation campaign. They are creating through a grassroots effort what they can’t seem to be able to (prove) with science.

“This is a bazooka against a fly. What are they doing? We’ve got misinformation everywhere.”

Herman says there is little doubt the FDA is moving to have all kratom products taken off the market.

“This is a concerted movement and it’s had a lot of disinformation with it,” he told PNN. “This is clearly what FDA wants to do. We hope the DEA has some thoughts against it, but no, there’s no question they want to ban it.”  

In 2016, the Drug Enforcement Administration attempted to ban kratom by scheduling it as an illegal controlled substance, but a public outcry and lobbying campaign forced the DEA to suspend its scheduling decision.

Herman said any renewed attempt to schedule kratom as a controlled substance would have to go through a public comment and hearing process, which could take a year or longer. He sees it as part of a larger effort by the FDA to have greater control over the loosely regulated dietary supplement industry.

“The only logical conclusion is that this is the first salvo in controlling the supplement business. We are on the frontline of a fight that will encompass a whole lot more than kratom,” Herman said.

Kratom Linked to Salmonella Outbreak

By Pat Anson, Editor

Kratom just can’t get a break. In recent weeks, the herbal supplement used by millions of Americans to treat chronic pain, depression and addiction has been blamed by federal agencies for dozens of fatal overdoses and even been called an opioid.

Now the Centers for Disease Control and Prevention has linked kratom to a salmonella outbreak and is recommending that people "not consume kratom in any form."

The bacterial infection has sickened 28 people, eleven serious enough to be hospitalized, but there have been no deaths. The outbreak began in October 2017 and has reached 20 states scattered around the country, which are highlighted in the map below.

“Epidemiologic evidence indicates that kratom is a likely source of this multistate outbreak,” the CDC said in a statement.

“In interviews, ill people answered questions about the foods they ate and other exposures in the months before they became ill. Eight (73%) of 11 people interviewed reported consuming kratom in pills, powder, or tea. No common brands or suppliers of kratom have been identified at this time."

The CDC statement did not say that Salmonella bacteria had actually been found in any samples of kratom. Nor did it explain how kratom use in 8 out of 28 cases establishes a link or proves that it was "a likely source."

The only "epidemiologic evidence" that investigators have established is that when they compared bacteria samples from people who were infected, they found the bacteria were closely related genetically.

"This means that people in this outbreak are more likely to share a common source of infection," the CDC said. "At this time, CDC recommends that people not consume kratom in any form. The investigation indicates that kratom products could be contaminated with Salmonella and could make people sick."

Salmonella is a bacterial infection usually spread through contaminated food or water. Most people who become infected develop diarrhea, fever and stomach cramps. Salmonella causes an estimated one million food-borne illnesses a year in the United States, with 19,000 hospitalizations and 380 deaths.

In the current outbreak, the CDC says there could be more cases than the 28 reported, because salmonella infections typically take 2 to 4 weeks before the illnesses are confirmed.

salmonella bacteria

It was a July 2016 report from the CDC that claimed kratom was linked to several overdose deaths and was “an emerging public health threat” that led the Drug Enforcement Administration to attempt to schedule kratom as an illegal controlled substance. Kratom supporters said the CDC research was amateurish and flawed, and a public outcry and lobbying campaign eventually forced the DEA to suspend its scheduling decision.

Earlier this month, the Food and Drug Administration released a computer analysis that found kratom contains over two dozen opioid-like substances – a report that critics say was biased and amounted to “junk science.” The computer analysis and a recent FDA public health advisory may indicate the federal government is planning another attempt at scheduling.

Kratom comes from the leaves of a tree that grows in Southeast Asia, where it has been used for centuries for its medicinal properties.

I Think of Death Every Day

(Editor’s note: Pain News Network regularly receives emails and comments from readers in physical and emotional distress because their chronic pain is not being treated or is undertreated. Many have been abandoned by their doctors. And some are having suicidal thoughts.

The following email came from “Sharon” – who lives with chronic pain from neuropathy and a severe hip injury. Sharon gave us permission to publish her email, as long as her full name was not disclosed. Some readers may find her story disturbing, but it is representative of what’s occurring in the pain community and therefore worth sharing.)

By Sharon

When I first got ill, I was an avid backpacker and ran a health food store. A very healthy and health conscious 37-year old woman.

I tried every alternative treatment.  The first was hypnosis. Then I tried colonics, lemon and oil heat packs, acupuncture, massage. The list goes on. NOTHING TOUCHED THE NERVE PAIN. 

I had an old .357 handgun. The same type police carried at one time. I also had an old .45.  I thought about it every single day. 

But I didn’t want my family or friends to find me like that.  A bloody picture in their heads whenever they thought of me.  

Taking your own life because of the ignorance of others, just isn’t fair.  To be pushed into it by others. Especially when there is medication that works.

Once I finally decided to try opiates, no doctor would listen to me.

I did everything they asked. I jumped through all the hoops. Multiple times. 

I was shamed over and over again, because I was in pain. I was called a malingerer. 

Never thought I would get sick at such a young age.   I thought I’d be healthy and happy like the all the other healthy women in my family.  

I finally did find a wonderful, caring doctor.  He treated me until just last year. When he was shut down.

I’m lucky. I did find another doctor. It took about 3 weeks. It was Christmas time.  Almost impossible. 

I like this clinic. But I have to drive 80 miles round trip.  

I’m 60. I’m not in good health. My husband passed away a few years ago.

My sweet little grandmother took her own life at 92. She was an amazing woman. 

I hope I never have to do that.  

But it’s in me. I could. I think of death every day.

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.

Osteoarthritis Drug Works No Better Than Placebo

By Pat Anson, Editor

Hydroxychloroquine (Plaquenil) is a medication commonly used to treat rheumatoid arthritis, lupus and other autoimmune diseases. It’s also being prescribed off-label to treat inflammation and pain caused by hand osteoarthritis, a joint condition that affects nearly a third of patients over the age of 70.

But in a new study published in the Annals of Internal Medicine, British researchers reported that hydroxychloroquine is no more effective than a placebo in relieving moderate to severe pain caused by hand osteoarthritis.

Researchers at the Leeds Institute of Rheumatic and Musculoskeletal Medicine and the Leeds Biomedical Research Centre randomly assigned 248 patients with radiographic hand osteoarthritis to either hydroxychloroquine (200 to 400 mg) or placebo for a year.

Most of the patients had symptoms of hand osteoarthritis for about 5 years, and their average pain level was 7 out of 10.

After 3, 6 and 12 months, there were no significant differences in treatment outcomes between the hydroxychloroquine and placebo groups.

“We found that HCQ (hydroxychloroquine) was not a more effective analgesic than placebo when added to usual care in persons with moderate to severe hand osteoarthritis,” researchers reported. “Background analgesic use did not differ between groups, and baseline inflammation and structural damage did not affect response to HCQ. The study therefore presents no evidence that HCQ should be considered within the management plan of patients with hand osteoarthritis.”

Two doctors who reviewed the study say more research is needed to find drugs that can treat the inflammation caused by hand osteoarthritis, a condition for which there are no effective therapies.

“The negative findings in this carefully done trial beg the question of what went awry. Did HCQ fail to reduce inflammation, or did reduced inflammation not translate to pain relief?” wrote Elena Losina, PhD, and Jefferey Katz, MD in an editorial.

“Although HCQ is safe, it is also a weak anti-inflammatory agent seldom used in contemporary practice as a solo disease-modifying therapy for rheumatoid arthritis and other inflammatory conditions. Further therapeutic studies of the effects of anti-inflammatory therapy on nodal hand osteoarthritis will need to use more potent agents or compounds developed to more specifically target the inflammatory pathways documented in this condition.”

Tell Medicare to Stop Its War on Pain Patients

By Richard A. Lawhern, Guest Columnist

In March 2016, the Centers for Disease Control and Prevention published a deeply biased and scientifically unsupported guideline for the prescription of opioid pain relievers.  Congress made this “guideline” mandatory in the Department of Veterans Affairs three months before it was even published.  The VA has since enacted practice guidelines that effectively eliminate opioids as a treatment option for many veterans. 

Now the Department of Health and Human Services and the Centers for Medicare and Medicaid Services (CMS) are doubling down on this bureaucratic atrocity.

CMS has posted in the Federal Register and is inviting public comment on its plans to change the rules for Medicare Part D prescription drug plans in 2019.  

They propose that "all sponsors [are] to implement hard formulary-level cumulative opioid safety edits at point-of-sale (POS) at the pharmacy (which can only be overridden by the sponsor) at 90 morphine milligram equivalent (MME)" – which is the dose ceiling recommended by the CDC.

The so-called “sponsors” are insurance companies that provide health care coverage funded by taxpayers to 54 million Medicare beneficiaries. If implemented, this proposal will effectively deny reliable pain treatment to millions of seniors, poor and disabled people.  When applied to private health insurance and Medicaid as they inevitably will be, these regulations will damage all U.S. citizens.

As I have commented to CMS, their proposals “mandate a dangerous, unfounded and medically unethical intrusion into medical practice by third parties operating without face to face knowledge of the patient. These … changes will damage and deny care to large numbers of the 1.6 million patients whom CMS estimates are presently treated with opioids above 90 morphine milligram equivalent dose per day.”   

Few pain patients ever display diagnostic symptoms of opioid use disorder. Yet drug-related overdoses have risen steadily in the past ten years -- despite restrictions on the medical supply of opioids -- a death toll largely associated with illegal opioids and nonprescription drugs. Managed medical exposure to opioids contributes almost nothing to the widely hyped “opioid crisis.”

Over-regulation of prescribing is already harming hundreds of thousands of stable patients coerced into opioid doses below therapeutic levels.  Mandated VA restrictions on opioid prescribing are directly responsible for hundreds of deaths among veterans. 

All for nothing.  And CMS is about to do more of the same.

A major study in the British Medical Journal illustrates the foolishness of the CMS proposal.  Diagnoses of opioid abuse disorder were tracked for 565,000 opioid-naïve post-surgical patients between 2008 and 2016. Only 0.6% were later diagnosed with Opioid Abuse Disorder (OAD).  Less than 1% renewed their prescriptions up to 13 weeks.  OAD incidence was only weakly sensitive to dose level from less than 20 to over 120  MME  per day.   

Another large study in JAMA Internal Medicine shows the incidence of extended post-surgical opioid prescriptions at just 0.174% to 0.9%, depending on the type of surgery.

CMS is trying to “solve” a non-problem by means guaranteed to create far worse problems.

The CDC Guidelines ignored the natural variability in liver enzymes governing the way opioids are broken down in the body.  Imposing hard limits on MME in “safety” audits will cause therapy failure in hundreds of thousands of patients who can benefit from opioids, but only at significantly higher doses than entertained by CDC and CMS. 

In January 2018 public hearings before the FDA Opioid Policy Steering Committee, the American Academy of Pain Management recommended against hard limits on opioid analgesics.  Other speakers advocated for leaving practice standards to medical professional associations which guide doctors in each specialty.  CMS has ignored both recommendations.

Forcing pain patients to go through an “exceptions” process before extending prescriptions beyond seven days is inappropriate and dangerous nonsense.  Prevailing practice allows for prescription duration sufficient to treat anticipated pain levels.  The alternative is to drown doctors in useless paperwork and to prompt patients to defer needed surgery because they fear being left without pain control.

There is no one-size-fits-all patient or treatment plan.  CMS should stand down from attempting to force restrictions on medical practice which have such predictable and horrid consequences.  

What Can Patients and Caregivers Do?

First, you can register your protest and concern with CMS before March 6th by selecting the “Comment Now!” buttons at this link.

You don’t have to be a doctor or researcher to do this.  Here are some examples of comments you might make.  Please edit them to fit your own situation.  Don’t copy these words exactly, as CMS will delete them.

    A. I am a chronic pain patient with ___________ (one or more diagnoses)

    B. My medical care will be greatly damaged by your regulation.

    C. I rely upon opioid medications to: (fill in)

• Preserve my way of life            
• Manage my incurable pain
• Allow for increased function
• Remain productive

     D. If CMS enforces a hard limit for opioid doses per day, this will give private insurance companies and pharmacies  an excuse to stop paying for my necessary prescriptions or dispensing them at all. 

     E. The proposed regulations are unsupported by any reliable science

     F. If enacted, these policies will: 

• Force even more doctors away from treating pain          
• Force more patients onto disability
• Create more demand for emergency room services
• Increase the rate of expensive and often ineffective surgical procedures
• Increase the rate of suicides

To review the comment process, feel free to visit the Facebook page for the Alliance for the Treatment of Intractable Pain (ATIP).

The second thing you can do is look up the Washington DC phone numbers of your House and Senate representatives. It’s easy. Just Google your state and the word “senators” or “Congress.”

Then call their office.  Tell the staffer who picks up that “I’m a pain patient and I vote in (name the state).  I want the Senator (Congressman or -woman) to tell the Centers for Medicare and Medicaid Services to withdraw their proposed regulation limiting the treatments I can receive.  If accepted, these regulations will destroy my life.”

It is time for people in pain and caregivers to speak up.  If we do not, then we will live – or die – as victims of a medical bureaucracy that doesn’t care about the damage it does to us.

Richard A Lawhern, PhD, is the co-founder and corresponding secretary for the Alliance for the Treatment of Intractable Pain (ATIP). He is a technically trained non-physician patient advocate with over 20 years experience in direct support to patients and caregivers in social media.  His work on public policy for pain management is widely published in multiple online and print media.

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

#MeToo and Bad Doctors

By Crystal Lindell, Columnist

I recently had a really bad experience with a doctor.

He tried to pressure me into getting a spinal cord stimulator that multiple doctors have said I should not get. And when I tried to say no, he got visibly angry and started being incredibly condescending.

He said my other doctors didn’t know what they were talking about. That I didn’t know what I what I was talking about. That the internet didn’t know what it was talking about. That everyone else was wrong, he was right and to disagree was painfully stupid.

And I have to tell you something, it impacted the same part of my brain and my soul that gets damaged every time a man tries to force me to do what I don’t want to do in a sexual situation. When he pushes well beyond all my boundaries, insisting on a date after I clearly said no. Insisting on more in bed, after I clearly said no.

I felt just as vulnerable in his office as I have with horrible men in their cars who tried to force me to kiss them while they ignored texts from their wives.

I can only imagine that this doctor is a man who is not used to hearing the word no, and I would guess that as much as he doesn’t like to hear it from his patients, he doesn’t like to hear it in romantic encounters either.

I was stressed about the whole thing for weeks after. And when I had to go back to his office for a treatment only they do locally, I had a nightmare the night before that the nurses there were chasing me down flights of endless stairs and setting my hair on fire.

Dreams are weird. But they are often a reflection of some larger truth. And the larger truth here was that the whole thing made me feel violated. And scared.

This was a man who wanted to do something to my body that I was clearly against him doing. And when I resisted, he just pushed harder to get his way and then insulted me for declining. It’s not so different from what many women face from men in the bedroom. And it felt just as traumatic for me.

There is a cultural shift happening for women. There’s #MeToo and #TimesUp, and as the French say, #BalanceTonPorc -- or squeal on your pig. The painful reckoning is happening, as we realize that half the population are actually human beings too.  

But if you are struggling to understand how it feels to be viewed as inferior all the time — either because you’re a man or one of the lucky women who hasn’t experienced it — I can tell you that sitting across from a doctor who doesn’t believe you, doesn’t trust you, and who implies you are too stupid to make decisions about your own body is a very similar feeling.

I wish I had some wise words to end this column on — that I could share some wisdom about how to make the world a better place. But the truth is, I don’t really know how to do that, at least not in any practical way that goes beyond just freaking be kind to the other people you encounter.

So I’ll just leave you with this potential for some sort of justice. I have reported this doctor. He is being investigated. And hopefully, it will save other patients the pain of such an experience — at least from him.

Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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

Does MSG Cause Chronic Pain?

By Pat Anson, Editor

Glutamate is a naturally occurring amino acid that is used in monosodium glutamate (MSG) as a flavor enhancer for processed food and soups as a flavor enhancer.

There have been many anecdotal reports of MSG causing headaches, nausea and fatigue – but the Food and Drug Administration found no evidence of that and declared that MSG is “generally recognized as safe.”

A small pilot study in central Africa suggests otherwise. Researchers at the University of Michigan and American University in Washington DC wanted to know why so many people in Meru, Kenya have widespread chronic pain – nearly two-thirds according to one survey.

Most suffered from neurological problems, including headaches or migraines, chronic fatigue, cognitive dysfunction, and sleep issues.

Researchers recruited 30 Meru residents for a study to see if diet and dehydration played a role in their symptoms, focusing on a local seasoning spice called mchuzi mix, which often contains MSG. The spice mix is known as the “flavor of Kenya” and is commonly used in multiple dishes throughout the day.

When some of the study participants were sent home with a mchuzi mix containing no MSG and urged to drink more water, they started showing significant improvement in their pain symptoms within two weeks. Many liked the flavor of the new mix and asked for more.

"This preliminary research in Kenya is consistent with what I am observing in my chronic pain research here in the United States," said Kathleen Holton, PhD, a nutritional neuroscientist at American University and lead author of the study published in the journal Nutrition.

"We don't know what exposure is leading to this susceptibility to dietary glutamate, but this pilot study suggests the need for a large-scale clinical trial, since dietary change could be an effective low-cost treatment option for developing countries."

Holton and her colleagues believe glutamate may act as a neurotransmitter in the brain and stimulate nerve cells. Increased consumption of glutamate may also enhance the central sensitization that leads to chronic pain.

“These preliminary findings support the hypothesis that MSG may be able to modulate pain response, and suggest that a future larger study is feasible and warranted in this population,” said Holton.

Researchers are planning a larger epidemiological survey to understand the prevalence of widespread chronic pain in the region and to train Kenyans on how to conduct a large-scale clinical trial. The goal is to see if dietary change could be an effective, low-cost treatment option for chronic pain.

"This would be incredible if we could impact chronic pain simply by making slight modifications to diet," said Daniel Clauw, MD, a University of Michigan professor and a leading expert on chronic pain.

Rare Disorders Require Unusual Care

By Roger Chriss, Columnist

A lawsuit challenging the constitutionality of listing cannabis as a Schedule I drug under the Controlled Substances Act is underway in New York City.

The plaintiffs, including an Iraq War veteran with PTSD and a 12-year-old girl with a rare seizure disorder, are claiming that the government’s decision to classify marijuana as an illegal controlled substance is irrational, unconstitutional and motivated by politics, not science.

The position of the federal government is simple: Marijuana has no accepted medical use and poses a significant risk of abuse and addiction.  But the situation is complex and emblematic of a larger issue – which is the medical treatment of people with rare and incurable disorders.

Modern medicine is an increasingly precise undertaking involving thousands of possible diagnoses, many with multiple treatment options.

There is a wide range of disorders that involve crippling anxiety, including post-traumatic stress disorder. There are also many seizure disorders, including conditions like Dravet syndrome and Lennox-Gastaut syndrome, that are extremely difficult to treat.

In the same fashion, there are hundreds of disorders that cause debilitating pain that persists for months, years or even a lifetime, including interstitial cystitis, Complex Regional Pain Syndrome, and trigeminal neuralgia.

Many of these disorders are rare and entirely unfamiliar to non-specialists. But even when the disorder itself is not so rare, its presentation may be rare in terms of severity. Fibromyalgia and osteoarthritis are common enough, but still can be debilitating in some cases.

As a result, research on such disorders is thin and clinical trials are few and far between. For instance, there are no studies of cannabis for small fiber neuropathy and only a handful on cannabis for cluster headaches. When trials do exist, they are easily criticized as being statistically underpowered because of the small number of participants.

Moreover, standard treatments do not necessarily work for everyone. Neuropathic pain sometimes responds well to neuroleptic drugs like gabapentin (Neurontin), but as a recent Cochrane review found, over half of those treated with gabapentin will not have worthwhile pain relief and may experience adverse side effects.

Usual Rules Don’t Apply

Many people with rare disorders are often medically atypical in other important ways. Patients with Ehlers-Danlos syndrome, for example, are famously intolerant of a wide range of medications. So the usual rules about medications may not even apply to people with rare disorders.

All of this creates obvious clinical difficulties. It is not easy to develop standards of care for rare disorders. General recommendations are based on limited clinical experience and testing, often with people whose reactions to common, generally well-tolerated medications are unpredictable and potentially dangerous. Thus, medications that are controversial may still be useful for people with rare disorders, especially if they are refractory to common treatments.

The opioid crisis has been national news for years, with many states, insurers like Kaiser Permanente and Intermountain Health, and drug store chains like CVS moving to reduce prescribing levels. But for some conditions, opioid medication remains one of the few viable alternatives.

For instance, the Mayo Clinic recognizes the value of opioids for refractory restless leg syndrome, calling them “a mainstay in the management of these patients.” And the National Institute of Neurological Disorders and Stroke acknowledges the complexity of neuropathic pain when it lists opioids and anticonvulsants as potentially useful.

The situation is similar for medical cannabis. The federal government gave marijuana Schedule I status in the 1970s, but many states legalized medical cannabis in the past two decades in part to deal with rare disorders that do not respond to conventional treatment. Clinical research is justifying this.  A 2017 trial of cannabidiol for drug-resistant seizures in Dravet Syndrome found that cannabis based medication reduced the frequency of convulsive seizures.

In other words, rare disorders involving problems such as severe pain, seizures or anxiety require highly specialized care using all available options. In many cases, people with these disorders have failed first-line therapies and even second-line therapies. They are facing choices that do not occur in everyday clinical practice but now have to be considered.

Thus, the issue here goes beyond rescheduling cannabis or reining in opioid prescribing. The average person has little if any medical need for these substances. But medicine has to address the needs of all people, and healthcare laws and regulations cannot ignore the reality that some people are living with challenging and rare disorders.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Doctor Arrested for Off-Label Prescribing of Subsys

By Pat Anson, Editor

A Las Vegas pain management doctor has been arrested and charged with 29 counts of healthcare fraud and unlawful distribution of fentanyl.

Steven Wolper, MD, was indicted by a federal grand jury for illegally prescribing Subsys, a fentanyl-based oral spray, to 22 patients that the doctor falsely claimed had cancer. Most of the patients were Medicare beneficiaries. One died of an overdose after self-injecting Subsys.     

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine.

The Food and Drug Administration has only approved Subsys for the treatment of breakthrough cancer pain. Although off-label prescribing of drugs is common in the medical profession, federal prosecutors maintain that “there are no off-label uses approved” for Subsys and that Holper prescribed it “without a legitimate medical purpose and outside the usual course of professional practice.”

One of Wolper’s patients – referred to as “Patient A” in the indictment -- received several prescriptions for Subsys starting in 2014. Two years later the patient died after using a syringe to inject leftover Subsys directly into their arm.

“Hundreds of Subsys canister sprays were found in and around Patient A’s bedroom, bathroom, work place, and vehicle after Patient A’s death,” the indictment says. “If Patient A had not used remaining fentanyl from the used Subsys canisters Patient A received from defendant Holper, Patient A would not have died when he/she did.”

If convicted, the 66-year old Holper faces up to 20 years in prison for illegal distribution of a controlled substance and 10 years for health care fraud.

“Dr. Holper is charged with needlessly prescribing one of the deadliest forms of opioids and defrauding U.S. taxpayers,” said FBI Special Agent in Charge Christian Schrank. “With our law enforcement partners we will continue our fight to bring these suspected criminals to justice and protect our communities.”

Subsys has been blamed for hundreds of overdose deaths, and federal prosecutors have accused its manufacturer, Insys Therapeutics, of fraud and racketeering in promoting its use. The Arizona drug maker allegedly misled insurers into paying for Subsys and encouraged doctors to prescribe it off-label for non-cancer pain.

The government’s willingness to prosecute Dr. Holper and a handful of other doctors for the off-label prescribing of Subsys could have potentially troubling implications for Dr. Forrest Tennant, a prominent California pain physician whose home and pain clinic were raided by the DEA last November.

Tennant only treats intractable pain patients and makes no secret of the fact that he prescribed Subsys off-label to about two dozen of his patients in severe pain. He considers Subsys a useful medication to treat non-cancer patients  who would otherwise suffer without it.

“My contention is that its perfectly acceptable to prescribe (Subsys) off-label,” Tennant told PNN, adding that he has a letter from an FDA commissioner stating that fentanyl products are not prohibited from off-label use. “I think the number of doctors who prescribed Subsys off-label is up in the hundreds.”

Tennant has not been charged with a crime and has denied any wrongdoing. 

The grand jury indictment of Dr. Holper came one week after Attorney General Jeff Sessions said there would a be a 45-day “surge” in law enforcement efforts targeting doctors and pharmacists who prescribe and dispense high doses of opioid medication.

"Our great country has never before seen the levels of addiction and overdose deaths that we are suffering today. Sadly, some trusted medical professionals like doctors, nurses, and pharmacists have chosen to violate their oaths and exploit this crisis for cash -- with devastating consequences,” Sessions said in a news release announcing Holper’s indictment.

“Our goals at the Department of Justice for 2018 are to reduce the number of opioid prescriptions, the number of overdose deaths, and violent crime -- which is often drug-related. That's why I created the Opioid Fraud and Abuse Detection Unit and sent 12 top prosecutors to opioid hotspots around the country: to help us find the medical fraudsters who are flooding our streets with drugs. These prosecutors are already issuing indictments from Pittsburgh to Las Vegas.”

Study Finds Little Evidence Shock Therapy Works

By Pat Anson, Editor

There is little evidence that electric shock therapy is an effective treatment for fibromyalgia, headache, degenerative joint pain and other chronic pain conditions, according to a new study by researchers at the Department of Veterans Affairs.

Cranial electric stimulation (CES) uses electrodes placed on the head to send small electric shocks to the brain to stimulate neurotransmitters.  Consumer interest in the therapy is increasing and several manufacturers make portable CES devices for home use -- such as the Fisher Wallace stimulator and Alpha-Stim AID -- marketing them as a treatment for pain, depression, anxiety and insomnia.

But in a review of 26 clinical trials published in the Annals of Internal Medicine, researchers found “limited evidence” to support the use of CES to treat these medical conditions. Many of the studies were small, had questionable validity and the reported results were often inconsistent. Some studies suggested that CES therapy could help patients with depression and anxiety, but the VA researchers say better studies were needed to prove it.

“The evidence for the effectiveness and safety of CES is sparse. Low-strength evidence suggests a beneficial association in patients with anxiety and depression. The intervention is probably safe, but strength of evidence is low,” wrote lead author Paul Shekelle, MD, of the West Los Angeles Veterans Affairs Medical Center.

In an editorial also published in the journal, a physician who uses CES therapy on his patients called the study findings “disappointing,” but said he and his colleagues would probably keep using the devices.

“I am not sure what my hospital will do with the information from this review. I know I will be less enthusiastic about recommending CES; however, I doubt that we will stop using it,” wrote Wayne Jonas, MD, of Samueli Integrative Health Programs in Alexandria, VA.

“When one of my patients, who had chronic pain, depression, and insomnia, finished her first CES treatment, she said she loved it. ‘I felt really relaxed,’ she said. ‘Can I have one of these at home?’ Our policy is to have patients try the treatment in the clinic at least 3 times. If it improves pain, depression, or insomnia, the patient can apply to get a home machine.”

The Food and Drug Administration first approved the use of CES in 1978 to treat depression, anxiety and insomnia. Because of that initial approval, the CES devices on the market today have not been required to prove their safety and effectiveness. The devices can be easily purchased online, but a prescription is required in the U.S.

Report Alleges Opioid Makers Bankrolled Patient Groups

By Pat Anson, Editor

U.S. Senator Claire McCaskill (D-MO) has released a scathing report that is sharply critical of patient advocacy groups and medical pain societies for accepting money from opioid manufacturers.

The report found that Purdue Pharma, Janssen Pharmaceuticals, Mylan, Depomed and Insys Therapeutics provided nearly $9 million to over a dozen non-profits and medical societies from 2012 to 2017.  In many cases, the amount of the donations was not fully disclosed by the recipients.

“These financial relationships were insidious, lacked transparency, and are one of the many factors that have resulted in arguably the most deadly drug epidemic in American history,” McCaskill's report alleges.

    Opioid Maker Payments to Advocacy Groups

• Purdue Pharma              $4,153,000
• Insys Therapeutics         $3,146,000
• Depomed                        $1,071,000
• Janssen                             $465,000
• Mylan                                  $20,250

Over the same five year period, physicians affiliated with the advocacy groups and medical societies accepted more than $1.6 million in payments from the opioid manufacturers.  

McCaskill, who is the top-ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, has long been critical of opioid prescribing practices and the role they played in fueling the so-called opioid epidemic.  Her report suggests that advocacy groups that criticized the CDC’s 2016 opioid prescribing guidelines did so to curry favor with drug makers -- not because of the well-documented harm the guidelines were causing pain patients.  

“Initiatives from the groups in this report often echoed and amplified messages favorable to increased opioid use — and ultimately, the financial interests of opioid manufacturers. These groups have issued guidelines and policies minimizing the risk of opioid addiction and promoting opioids for chronic pain, lobbied to change laws directed at curbing opioid use, and argued against accountability for physicians and industry executives responsible for overprescription and misbranding,” the report found.

"The fact that these same manufacturers provided millions of dollars to the groups described below suggests, at the very least, a direct link between corporate donations and the advancement of opioids friendly messaging. By aligning medical culture with industry goals in this way, many of the groups described in this report may have played a significant role in creating the necessary conditions for the U.S. opioids epidemic."   

Top 10 Recipients of Funding from Opioid Makers

1. U.S. Pain Foundation                                                      $2.922,000
2. American Academy of Integrative Pain Management     $1,265,000
3. American Academy of Pain Medicine                              $1,199,000
4. American Pain Society                                                       $962,000
5. National Pain Foundation                                                   $562,000
6. Washington Legal Foundation                                           $500,000
7. American Chronic Pain Association                                   $417,000
8. American Society of Pain Management Nursing                $323,000
9. AAPM Foundation                                                              $304,000
10. Center for Practical Bioethics                                             $163,000

"Sen. McCaskill and the others haven’t spent the necessary time talking to us to understand how we do things and what we have to offer," Bob Twillman, PhD, Executive Director of the American Academy of Integrative Pain Management said in a statement. "It appears that they’ve simply looked at how much money we got from a set of pharma companies, constructed a narrative about what that means, and published it."

Perhaps the most surprising detail in the report is the amount of money Insys Therapeutics gave to the U.S. Pain Foundation – over $3.1 million --- with $2.5 million paid in 2017 alone. Insys is the manufacturer of Subsys, a potent fentanyl-based spray that has been blamed for hundreds of overdose deaths.

Former Insys executives and sales representatives have been charged with racketeering and bribing doctors to prescribe Subsys off label to non-cancer patients. The Arizona drug maker has also been accused of misleading and defrauding insurance companies to pay for Subsys, which can cost tens of thousands of dollars for each 30-day prescription.

U.S. Pain founder and president Paul Gileno released a statement defending his non-profit's acceptance of the Insys money. He said the funds were used by the organization to fund a co-pay assistance program for cancer patients.   

"This funding, like any funding we receive, does not influence our values. When it comes to opioids, we believe both that people with legitimate pain have a right to effective care and that systematic changes must be made to address the ongoing opioid crisis," Gileno said.

McCaskill’s report makes no mention of the increasing role played by illegal opioids, such as heroin and illicit fentanyl, in fueling the opioid epidemic. A recent CDC report blamed illicit fentanyl for over half of the overdoses in ten states -- including McCaskill's home state of Missouri.  

Law Firms Major Donors to McCaskill Campaign

According to OpenSecrets.org, McCaskill has received over $6 million in campaign donations from law firms since 2005, including some currently involved in litigation against opioid manufacturers. Contributors affiliated with the law firm of Simmons Hanly Conroy have donated over $300,000 to McCaskill, who is running for re-election this year.

Simmons Hanly Conroy represents dozens of states, counties and cities that are suing Purdue Pharma and other drug makers over their marketing of opioids, and would pocket one-third of the proceeds from any settlement, according to reports.

A statement on the Simmons Hanly Conroy website claims the law firm "effectively invented large-scale, multi-defendant opioid litigation" and is a "trusted ally to local and state governments who seek justice and reprieve from the often debilitating costs associated with fighting the opioid crisis."

According to a survey of over 3,100 patients by Pain News Network and the International Pain Foundation, the CDC guidelines have reduced access to pain care, harmed many patients and caused some to consider suicide. Over 70 percent said their opioid medication had been reduced or cutoff by doctors, and 11 percent said they had obtained opioids illegally for pain relief since the guidelines came out.