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. 

Medical Cannabis Effective for Elderly Pain Patients

By Pat Anson, Editor

Medical marijuana can significantly reduce chronic pain in elderly patients without adverse effects, according to a new study by Israeli researchers that found many patients were also able stop or reduce their use of opioid medication.

Researchers at the Ben-Gurion University of the Negev (BGU) surveyed over 2,700 patients 65 years or older who received medical cannabis. Over 60 percent of the patients were prescribed cannabis for chronic pain due to cancer, Parkinson's disease, post-traumatic stress disorder, ulcerative colitis, Crohn's disease, multiple sclerosis or other medical issues.

drug policy alliance image

After six months of treatment, more than 93 percent of respondents reported their pain dropped from a median of eight to four on a 10-point pain scale. Nearly 60 percent who originally reported "bad" or "very bad" quality of life said their lives had improved to "good" or "very good." And over 70 percent reported moderate to significant improvement in their medical condition.

About a third of the patients used cannabis-infused oil, about 24 percent smoked marijuana, and about six percent used a vaporizer. The most common side effects from cannabis use were dizziness and dry mouth, researchers reported in The European Journal of Internal Medicine .

"We found medical cannabis treatment significantly relieves pain and improves quality of life for seniors with minimal side effects reported," said Victor Novack, MD, a professor of medicine at BGU and head of the Soroka Cannabis Clinical Research Institute.

"While older patients represent a large and growing population of medical cannabis users, few studies have addressed how it affects this particular group, which also suffers from dementia, frequent falls, mobility problems, and hearing and visual impairments."

The survey found that nearly one in five patients stopped using opioid medication or reduced their dose. The findings are at odds with a recent study by the RAND Corporation, which found that medical marijuana laws in the U.S. have not reduced demand for prescription opioids.

Medical marijuana has been legal in Israel since the early 1990s. Israel’s Ministry of Health still considers cannabis a “dangerous drug,” but adds “there is evidence that cannabis could help patients suffering from certain medical conditions and alleviate their suffering.”

A recent survey found about 27 percent of Israeli adults have used cannabis in the past year, one of the highest rates in the world.

Do OTC Pain Relievers Dull Your Emotions?

By Pat Anson, Editor

Ibuprofen, acetaminophen and other over-the-counter pain relievers may do more than just dull your physical pain. They could also dull your emotional and cognitive senses, according to a new study.

Researchers at the University of California, Santa Barbara reviewed a small body of clinical studies that suggest OTC pain medications have an overlapping effect on us, both physically and emotionally.

One study, for example, found that acetaminophen makes people feel less empathy for others.

Research also found that women who took ibuprofen reported less social anxiety and hurt feelings after being excluded from a game or when writing about a time when they felt betrayed.

Yet another study found that acetaminophen lessens the discomfort of parting with a prized possession. When asked to set a selling price on an object they owned, individuals who took acetaminophen set prices that were cheaper than the prices set by individuals who took placebos.

"In many ways, the reviewed findings are alarming," wrote lead author Kyle Ratner, PhD, an assistant professor of psychology at UC Santa Barbara. "Consumers assume that when they take an over-the-counter pain medication, it will relieve their physical symptoms, but they do not anticipate broader psychological effects.

“Are more regulations needed? Should warnings be expanded on drug labels? At this point, drawing strong conclusions from the existing studies would be premature. Nonetheless, policymakers might start thinking about potential public health risks and benefits.”

Ratner and his colleagues say one place to start is to further study the effects of OTC analgesics on pregnant women. Recent research has found higher rates of autism and attention deficit disorder (ADHD) in young children whose mothers used acetaminophen while pregnant.

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. Ibuprofen is also widely used and can be found in brand name products such as Motrin and Advil.   

“Found in medicine cabinets across the world and used multiple times per week by people of all ages, genders, and ethnic backgrounds, these drugs are woven into modern life. Policymakers should take note of existing findings but not rush to judgment,” said Ratner.

The study is published online in the journal Policy Insights from the Behavioral and Brain Sciences.

Jeff Sessions, Aspirin and Toughing It Out

By Crystal Lindell, Columnist

My first reaction to reading that Attorney General Jeff Sessions thinks pain patients should just “tough it out” was probably not appropriate for this publication.

My second reaction probably wasn’t either.

If you haven’t heard, Sessions hates drugs. Like a lot. He literally once said, “good people don’t smoke marijuana.”

And now, he apparently thinks good people shouldn’t use opioid pain medication.

"I am operating on the assumption that this country prescribes too many opioids," Sessions said during a speech at the U.S. Attorney’s office in Tampa. "People need to take some aspirin sometimes and tough it out.”

Okay. Look. Setting aside the fact that data consistently shows that most people do not start heroin because they received a legitimate hydrocodone prescription, let’s talk about this whole idea of “toughing it out.”

Because that’s the thing about pain, when it’s not yours, it’s incredibly easy to endure. All you really have to do is throw around clichés about being a strong person, and maybe sprinkle in some lame advice about yoga and acupuncture.

Depending on your mood, you might even add in a few judgmental asides about avoiding gluten and getting enough exercise. And just like that: Voila! You’ve dealt with it! Problem solved.

But when it’s your pain. When it’s eating away at your soul, it’s never that easy. And it never gets easy.

Left untreated, the pain that wraps around the right side of my ribs has left me dreaming of drowning in a bottle of Drano just to make it stop. It has buried me in bed and left me for dead, so heavy on my chest that I can’t get up. It has stolen my nights and destroyed my days. And it has done its very best to rob me of my hope. 

In short, it’s been hell. And the words that would make you truly understand how awful it has been do not exist.

But thankfully, I found a doctor who has helped me get through hell and manage my constant pain with opioid pain medications.

And it’s because of those medications that I can live. I can work. I can be a friend, and a sister, and a lover, and a writer, and daughter. I can be connected to the magic of the universe again.

There is so much we can do to fight the opioid epidemic. Those suffering from addiction need long-term treatment that includes professional psychiatric help. They need to be offered medicated withdrawal when needed, and given a strong support system. And they need empathy.

In fact, it’s the same empathy pain patients need, just applied differently.

I don’t expect a man like Jeff Sessions to understand this. He has never been in horrific pain. And honestly, as much as I hate him, I hope he never is.

But if he does wake up with pain one day, and realizes how important it is to treat that pain, I hope he looks back on his life with regret and remorse, as he realizes how incredibly wrong he was to ever suggest that people in pain “tough it out.”

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 February 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.

Motivational Speaking for the Pain Community

By Barby Ingle, Columnist

There are many types of patient advocates. One of my favorite is being a motivational speaker. Sharing my personal story of trials and challenges -- and how I overcame them -- is motivational to me and inspirational to those who have heard me speak at pain conferences.

I often get the comments like: How did you learn to be a motivational speaker? How can I share my story with the world?

Many pain sufferers have compelling stories of over treatment, undertreatment and mistreatment by the medical system, but they are not as focused as they need to be for motivational speaking. I'd like to share a few tips that I’ve learned.

First, you have to create a plan. You have to become the expert of your own story. And you need to develop a goal or outcome that you want your listeners to learn – an “action item” for them when your presentation ends.

After you organize your thoughts and create your presentation plan, figure out how long your talk is going to be. You could be allotted anywhere from 10 minutes to an hour to speak. I know I could go on for 8 hours straight on some topics. Do you need to save time for questions? Do you want to allow people to interrupt you during your presentation or after?

Where do you speak? If this is totally new to you, you may want to start at your child’s school for career day. Yes, being disabled and having chronic pain is equivalent to a career. I actually wish some of the parents who were disabled or chronically ill when I was growing up would have come to my school to do a presentation. It helps plant a seed, so that if a child or their family member finds themselves in a similar situation, they can remember the lessons they learned.

Another place to speak is your church or local library. After you speak 10-20 times to smaller groups and develop a focused and polished presentation, you can turn to your local hospitals and pain clinics and see if they need a presentation from the patient’s perspective. There are also online opportunities, such as webinars put on by nonprofits, Facebook or Periscope live sessions that can help you practice and develop your public speaking skills.

As you build experience, you will sharpen your message, get better at understanding your audience, and learn what is best to skim over and what is important to present in full. Having backup material to present is also very helpful.

Be prepared for anything. I once passed out during a speech. Just fell over. How would you handle it? I had them bring me a chair and a water bottle. Now I always go on stage with a water bottle.

Finally, understand that motivational speaking is not for everyone. It takes someone who is organized and willing to share the messy details of their life with actionable goals on how to turn it around. As my friend Judy Carter says, “You can’t have a message without a mess.”

It takes work. I practiced speaking with my dad and husband, tape recording myself to see how many “um's” and “like, you know” I was saying and how to cut them out. The secret is practice and preparation.

The breakdown of steps for me goes like this:

1. Write down your topic, facts, personal story and the “take away” for listeners
2. Practice by yourself
3. Practice in front of someone
4. Put yourself out to the world as a potential speaker
5. Stay within your allotted time -- which requires you to be focused and practiced
6. Allow time for questions at the end. If no one has any, have a recap message ready so you can end on a positive and productive note.

Keep in mind that you are a pain patient and sometimes you have to prepare by resting – both before and after your talk. The endorphins I get when on stage are a pain reliever for me, but when they wear off I hit the bed and need a few days of recovery. Be ready for this to happen to you.

It’s more important than ever for pain sufferers to share their stories. We are poorly understood and often ignored when decisions are made about our healthcare. We need to be our own best advocates – whether it’s testifying at a legislative hearing, participating in a pain support group, or speaking at your child’s school.

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