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

Kratom Supporters Say Ban Would Worsen Opioid Crisis

By Pat Anson, Editor

Nine scientists are warning that a renewed effort to make the herbal supplement kratom an illegal Schedule I controlled substance would worsen the opioid crisis and lead to more overdoses.

“It is our collective judgment that placing kratom into Schedule I will potentially increase the number of deaths of Americans caused by opioids because many people who have found kratom to be their lifeline away from strong opioids will be vulnerable to resumption of that opioid use,” wrote lead author Jack Henningfield, PhD, in a letter to Acting DEA administrator Robert Patterson and White House advisor Kellyanne Conway.

“A ban on kratom that would be imposed by CSA Scheduling would put them at risk of relapse to opioid use with the potential consequence of overdose death. Similar unintended consequences are to be expected in some who would be forced to use opioids to manage acute or chronic pain.”

The letter was released by the American Kratom Association (AKA), a pro-kratom consumer group, in response to an FDA analysis this week stating that kratom contains risky chemical compounds that act as opioids.   

“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use,” said FDA Commissioner Scott Gottlieb, MD, in a lengthy statement.

“As the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant – it’s an opioid. And it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms."

Kratom comes from a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties. Kratom leaves are typically ground up into powder to make tea or used in capsules. Millions of Americans have discovered kratom in recent years, using it to treat chronic pain, anxiety, depression, and addiction.

In 2016, the Drug Enforcement Administration tried to list two of kratom’s active ingredients as Schedule I substances, which would have made it a felony to sell or possess kratom. The DEA suspended its plan after a public outcry and asked for a full medical evaluation of kratom from the FDA.

KRATOM POWDER

The new report from the FDA -- which links kratom to dozens of overdose deaths – seems likely to trigger a new effort by the DEA to make the herb an illegal controlled substance. That would be a serious mistake, according to the scientists engaged by the AKA, because it would stifle kratom research.

“Placing kratom into Schedule I of the CSA (Controlled Substances Act) will also have a profound and pervasive chilling effect on this needed additional research,” they wrote. “The federal government should be encouraging additional research into the potential benefits of kratom, as well as the possibility that extracts of kratom and/or new medicines that are similar to kratom’s active ingredients might serve as breakthroughs in pain relieving medicines that are so desperately needed.”

The letter was signed by scientists and researchers affiliated with the Johns Hopkins University School of Medicine, Columbia University, Temple University School of Medicine, University of Rochester Medical Center, University of British Columbia, and other academic and medical institutions.

Sessions Tells Pain Patients to ‘Tough It Out’

By Pat Anson, Editor

Take two aspirin and call me in the morning.

That old cliché is finding new life – at least in the mind of U.S. Attorney General Jeff Sessions --- who suggested twice this week that aspirin is the solution to the nation’s opioid crisis.

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

During his 25-minute speech, the Tampa Bay Times reported that Sessions veered away from his prepared remarks to cite the example of White House chief of staff Gen. John Kelly, who refused to take opioid painkillers after recent minor surgery.

"He goes, ‘I’m not taking any drugs,’" Sessions said, drawing a laugh while imitating Kelly. "But, I mean, a lot of people — you can get through these things."

"That remark reflects a failure to recognize the severity of pain of some patients," said Bob Twillman, PhD, executive director of the Academy of Integrative Pain Management.

JEFF SESSIONS

"It’s an unconscionable remark," Twillman told the Tampa Bay Times. "It further illustrates how out of touch parts of the administration are with opioids and pain management."

Sessions made similar statements Tuesday night at a Heritage Foundation event marking the birthday of President Ronald Reagan.

"Sometimes you just need to take two Bufferin or something and go to bed," said Sessions, who added that his goal in 2018 was to see a continuing decline in opioid prescriptions, which have been falling since 2010.

“We had a 7 percent decline last year in actual prescriptions of opioids. We think doctors are just prescribing too many,” he said. “These pills become so addictive. The DEA says a huge percentage of the heroin addiction starts with prescriptions. That may be an exaggerated number. They had it as high as 80 percent. We think a lot of this is starting with marijuana and other drugs too.”

Sessions was referring to a single but often-cited survey, which found that most heroin users in addiction treatment also abused prescription opioids. The fact is most addicts try a variety of different substances – such as tobacco, marijuana, alcohol and opioid medication – before moving on to heroin. It is rare for a legitimate patient on legally prescribed opioids to use heroin.  

The Drug Enforcement Administration – an agency that Sessions oversees – has ordered a reduction in the supply of prescription opioids in 2018. That’s in addition to steep cuts in opioid production quotas the DEA imposed in 2017.  The agency ignored dozens of public comments warning that further reductions this year in the opioid supply could create shortages.  

Medical Marijuana Not Reducing Demand for Rx Opioids

By Pat Anson, Editor

A new study by the RAND Corporation is throwing some shade on theories that medical marijuana reduces demand for prescription opioids and saves lives by lowering rates of opioid overdoses.

RAND researchers analyzed data from 1999 to 2010 and found a 20 percent decline in opioid overdose deaths associated with the passage of state medical marijuana laws. That is in line with previous studies. However, when researchers extended their analysis through 2013, they found that the association between medical marijuana and lower rates of opioid deaths completely disappeared.

Researchers say there are two possible explanations for this. First, states that recently adopted medical marijuana laws are more tightly regulating dispensaries -- which may have reduced access to cannabis. Second, beginning in 2010, the primary driver of the overdose crisis became illicit opioids such as heroin and fentanyl, not prescription opioids.

“This is a sign that medical marijuana, by itself, will not be the solution to the nation's opioid crisis," said Rosalie Liccardo Pacula, co-director of the RAND Drug Policy Research Center and co-author of the study published in the Journal of Health Economics.

"Before we embrace marijuana as a strategy to combat the opioid epidemic, we need to fully understand the mechanism through which these laws may be helping and see if that mechanism still matters in today's changing opioid crisis."

The RAND study also found little evidence that states with medical marijuana laws experience reductions in the volume of legally prescribed opioid medication.

"If anything, states that adopt medical marijuana laws... experience a relative increase in the legal distribution of prescription opioids. This result suggests that our findings are not driven by a decrease in the legal supply of opiioids," researchers found.

While many patients are using medical marijuana products to treat their pain, researchers say they do not represent a significant part of the opioid analgesic market.

"Either the patients are continuing to use their opioid pain medications in addition to marijuana, or this patient group represents a small share of the overall medical opioid using population," said Pacula.

Although 29 states and the District of Columbia have legalized medical marijuana and a handful of states allow its recreational use, marijuana remains illegal under federal law. Attorney General Jeff Sessions recently ordered U.S. Attorneys to resume enforcing federal laws that outlaw the cultivation, distribution and possession of marijuana. Session rescinded the Cole memo, a lenient policy adopted by the Justice Department in 2013 that instructed U.S. Attorneys not to investigate or prosecute marijuana cases in states that have legalized cannabis..

Darknet Markets and the Opioid Crisis

By Roger Chriss, Columnist

Darknet drug markets are far larger, more pervasive and more involved in the opioid crisis than is generally realized.

The U.S. Senate recently released a report stating that $800 million worth of fentanyl pills were illegally sold online to customers in the U.S. over a two-year period. Purchases were made from 43 states, with the most orders coming from Ohio, Pennsylvania and Florida.

Sellers are so sophisticated they accept multiple forms of payment, preferring Bitcoin because the cryptocurrency is hard to trace. But they are also using Western Union, MoneyGram, PayPal, credit cards, and prepaid gift cards.

But the Senate report barely scratches the surface of the online drug market.

Drugs have been available online since the beginning of the internet. Legend says that the first online purchase ever made was for a bag of marijuana in the 1970s in California.

By the 1990s, drug dealers and traffickers had adopted mobile communications to reach buyers and avoid detection, and the Open Vendor Database listed classified ads for a variety of substances.

The rise of Web 2.0 technology and online shopping led to the Silk Road, the first modern darknet market. Silk Road came online in February 2011 and gained immediate attention in the geek community. Gawker published an article about it in June 2011, and Wired.com also covered its increasing influence and ultimate downfall in 2013.

More darknet markets arose in the wake of Silk Road, including its immediate successors, Silk Road 2.0 and Silk Road Reloaded, as well as Utopia, Agora, and AlphaBay. All relied on internet protocols to anonymize their communications and cryptocurrencies like Bitcoin for relatively secure transactions.

The Tor anonymity network was developed in the mid-1990s by the U.S. Naval Research Lab to protect online intelligence communications. It was designed to be highly secure and easy to use, and is still primarily funded by the federal government. Its purpose is to safeguard journalists and dissidents, and to enable U.S. intelligence operations overseas. But because of how it works, it is well suited for illegal activities, too.

In other words, the internet now makes for an almost ideal operating environment for illegal drug markets. The globalization of the industrial marketplace, efficient international shipping and low-cost mobile communications enable some of these markets to function as efficiently and effectively as online retailers like Amazon.

Modern Darknet Markets

The modern darknet is now a major source of heroin, illicit fentanyl and other illegal opioids, as well as virtually every other illegal substance imaginable. The scale of this market is staggering, and its efficiency is stunning. Darknet markets look like familiar online merchants, complete with user reviews, shipping information and promotions, as well as excellent customer service. In practical terms, this means that a person who wants a particular substance can obtain it almost overnight with little more than a few clicks or taps.

The darknet is sufficiently sophisticated to have its own news sites, market information and discussion forums. Activity is tracked and discussed with precision and zeal.

Measuring the precise size of the darknet economy can be challenging. From 2013 to 2015,  Carnegie Mellon researchers estimate that darknet sales volume fluctuated between $100 million and $180 million annually. Importantly, sales volume remained about the same even after law enforcement crackdowns and arrests.

The darknet operates with relative impunity for a variety of reasons. Drugs are sourced from manufacturers in multiple countries, not just China, and substrates for these drugs are also sourced from multiple locations. Thus, the manufacturing supply chain is not vertically integrated and cannot be easily disrupted. Instead, it is highly diversified, making it robust against arrests, takedowns and product interdiction.

Transport and delivery of drugs involve not only the U.S. Postal Service, but every other mode of shipping. This includes conventional approaches like UPS and FedEx, as well as private courier services and livery companies. It extends to tunnels, boats, aerial drones and ad hoc transportation services arranged online.
 
In addition to darknet markets, there are also unlicensed online pharmacies, pill mills, and rogue physicians. It is not clear if the darknet is supplying street dealers, but it seems safe to assume that these illegal operations are interacting in mutually beneficial ways.

Attorney General Jeff Sessions recently announced the formation of the Joint Criminal Opioid Darknet Enforcement (J-CODE) unit, which is made up of federal agents and cyber experts whose aim is to dismantle darknet markets. This comes on the heels of the newly formed Opioid Fraud and Abuse Detection Unit, whose focus is opioid-related healthcare fraud.

While these efforts may help reduce the flow of illegal drugs, they will have to be highly innovative in their approach. Darknet markets have quickly recovered from previous law enforcement crackdowns and are more resilient than ever. Many are located outside U.S. jurisdiction, often with people in one nation, technology in another, and merchandise in yet another, making investigation and extradition very difficult.

In other words, defeating darknet markets is akin to eliminating a termite infestation when the nest is not on your property. New approaches will be needed, and addiction prevention and treatment become all the more important when the flow of illegal addictive substances cannot be readily slowed.

Darknet markets are playing an increasingly important role as a source of heroin and illicit fentanyl, the two key drivers in the opioid crisis. This is not surprising given the history of drugs online and the fact that opioid abuse and addiction usually starts with recreational use. A failure to recognize this -- exacerbated by efforts to shrink the supply of legal prescription opioids -- has hampered the response to the opioid crisis and is contributing to rising overdose fatalities.

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.

FDA Report Calls Kratom an Opioid

By Pat Anson, Editor

The herbal supplement kratom contains opioids and should not be used to treat any medical condition, according to a new analysis by the U.S. Food and Drug Administration. The report seems likely to trigger a renewed effort to classify kratom as an illegal Schedule I substance under the Controlled Substances Act.

“Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use. And claiming that kratom is benign because it’s ‘just a plant’ is shortsighted and dangerous,” said FDA Commissioner Scott Gottlieb, MD, in a lengthy statement.

“It’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms.”

Kratom comes from the leaves of a tree that grows in southeast Asia, where it has been used for centuries for its medicinal properties.  Millions of Americans have discovered kratom in recent years, using it to treat chronic pain, anxiety, depression, and addiction.

In 2016, the Drug Enforcement Administration attempted to list two of kratom’s active ingredients as Schedule I substances. The DEA suspended its plan after a public outcry, and said it would wait for a scheduling recommendation and medical evaluation of kratom from the FDA.

The new report may prompt the DEA to try again.  In a computer analysis using what the FDA calls Public Health Assessment via Structural Evaluation (PHASE) methodology, FDA researchers identified 25 chemical compounds in kratom that share structural similarities with opioid analgesics such as morphine. Like painkillers, the substances bind to mu-opioid receptors in the brain and – according to the computer models -- act the same way as opioids.

“The data from the PHASE model shows us that kratom compounds are predicted to affect the body just like opioids. Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids,” Gottlieb said.

FDA Analysis Called ‘Junk Science'

Critics of the FDA analysis say it contains numerous errors and signs of confirmation bias.

"The failure of the FDA to justify its attempt to schedule kratom using traditional and well-accepted scientific methods has apparently driven the FDA to move into the world of junk science.  Using computer modeling is very susceptible to bias in the assumptions the are built into the computer algorithms.  In short, the old adage of 'garbage in – garbage out' applies to such dramatic testing standards," said Dave Herman, chairman of the American Kratom Association (AKA), a pro-kratom consumer group.

In addition to its analysis, the FDA released a detailed report on 36 deaths associated with kratom over the past several years. The agency admits all but one of the overdose deaths involved other drugs and “could not be fully assessed.” There was only one death involving a person who had no prior opioid use.  

“We’re continuing to investigate this report, but the information we have so far reinforces our concerns about the use of kratom. In addition, a few assessable cases with fatal outcomes raise concern that kratom is being used in combination with other drugs that affect the brain, including illicit drugs, prescription opioids, benzodiazepines and over-the-counter medications, like the anti-diarrheal medicine, loperamide,” Gottlieb said.

"It is more of the same useless rhetoric from FDA," says Jane Babin, a molecular biologist who authored a report last year for the AKA that discredited many of the reports linking overdoses to kratom.

"Bottom line:  36 deaths over 3, 5, 7 or more years that they can't prove were caused by kratom, versus 16,000 deaths from killer street opioids," Babin wrote in an email. 

In a survey of 6,150 kratom users by Pain News Network and the AKA, most reported they used kratom as a treatment for chronic pain, depression, anxiety or addiction. Many say the herb is safe, effective and has literally saved their lives

“Kratom is the one thing that has kept me from using opiates and other illegal substances. I've been able to stay clean for 3 years now. It's given me my life back,” one survey respondent wrote.

“Kratom is the only reason I was finally able to end my addiction to hydrocodone. It is nowhere near as potent as hydrocodone, and you can't overdose” said another.

“I've had several friends who have died from heroin overdose. If they knew about kratom they may still be alive today,” wrote another kratom user.

One of the dilemmas faced by the FDA and DEA is that kratom products are currently classified as dietary supplements, and there are few regulatory standards applied to their importation or ingredients. The only requirement for kratom vendors is that they don't make unsubstantiated health claims. Classifying kratom as a Schedule I controlled substance would radically change that, making it a felony to possess or sell kratom, and likely creating an underground black market for the herb.

Oska Pulse Reduces Knee, Shoulder and Back Pain

By Pat Anson, Editor

A wearable device that stimulates the release of natural pain-relieving endorphins provides significant relief to patients with chronic knee, shoulder or back pain, according to the results of small clinical trial.

The Oska Pulse uses Pulsed Electromagnetic Field technology (PEMF) to dilate blood vessels, which increases blood flow, reduces inflammation, and releases the body’s endorphins to reduce joint and muscle pain.

The double blind, placebo-controlled study involved 30 patients who were recruited from two San Diego area pain clinics. Participants were given either an Oska Pulse or a placebo device and asked to wear them several times a day for two weeks, while completing a daily log to track their pain, stress and usage.

The study findings, first published in Practical Pain Management, found that the majority of participants who used the Oska Pulse had a significant decrease in pain levels. Some also reported a decrease in stress.

oska wellness image

“There was significantly more reduction in pain in the OSKA Pulse group after 14 days of use than placebo. These results suggested that the OSKA Pulse may be an effective tool in pain attenuation,” wrote lead author Joseph Shurman, MD, an anesthesiologist at Scripps Memorial Hospital in La Jolla, CA.

“Data analyses showed interesting trends in subjective pain scores, including a slight increase in pain in the placebo group after day 7, while the OSKA Pulse group, on average, reported a decline in pain intensity.”

Previous studies have found that PEMF therapy can be used to treat a variety of chronic pain conditions, not just simple muscle aches and joint pain. A recent survey of Oska Pulse users found that half had some type of pain for more than five years.

"I've had RSD/CRPS in my left leg for 21 years and tried many meds and treatments over the years, including 10 years of ketamine infusions," said Tracey M., an Oska customer quoted in a news release. "I started using Oska Pulse nine months ago and my pain was reduced more than ever before. I recently danced at my daughter's wedding. Before Oska, I wasn't even sure if I'd be able to attend."

PNN columnist Arlene Grau, who lives with rheumatoid arthritis and fibromyalgia, was at first skeptical about the Oska Pulse. But after trying it for several days, she found the device gave her some temporary pain relief.

“I originally thought the Oska Pulse was not going to work for me, since I'm used to the TENS unit shocking my body and actually feeling something happening. You don’t really ‘feel’ anything when the Oska Pulse is on, but I felt a difference after every use,” Arlene said. “I wouldn't necessarily compare it to the relief I get from opioids, but it was enough to make me feel like I didn't need to take prescription drugs every 4 hours. Which is a triumph.”  

Before using the Oska Pulse, it is recommended that cancer patients, or those who are pregnant, nursing, or have a pacemaker or defibrillator, should consult with their physician.

The Oska Pulse is available on Amazon for $399.

A Pained Life: Tough Luck

By Carol Levy, Columnist

For the first time in almost 40 years, two doctors said the same words to me, the words I have always dreaded: “Tough luck.”

Their words were meant to be kind, but the meaning was the same: There is no cure.

That is the last thing I want to hear.  The last thing most of us want to hear.

I am a new patient of both doctors. They do not realize I am like a woman who fell overboard, clinging desperately to the side of the ship. I cling desperately to hope – the hope that someday, someone, something, will end the pain. It is what keeps me fighting.

It is that little sliver of hope, even after all this time, that there is an answer. And then I could work again. Do anything I want to do. And do it without pain.

For all intents and purposes, I have been mostly housebound for the last 39 years, except for 3 months in 1977 when I had my first and only completely successful surgery.  I got a job as soon as I was permitted. I made wonderful new friends. We went out every weekend and during the week too. It was glorious. And then, one day while at my desk, a trigeminal neuralgia pain tore into my temple. And my life was lost again to the demon pain.

I do get out of my apartment. I take a class 2 times a week at my local Y. I am active in politics and try to get to the  monthly meeting and other events. I go to the grocery, the bank and doctor's appointments. All of these make the eye usage and eye movement pain much worse, but I do them and get through them (sometimes with a little narcotic helper). But absent those times, I am home.

The pain comes even when I am doing nothing. Staying home does not give me control over it. But by staying in, I reduce the number of times I am actively inviting the pain to get worse. Little by little, unconsciously, I am miniaturizing my life, doing as few things as possible so I don't exacerbate the pain.

This is no way to live, so I still search.

My pain management doctor tries new medications. They have not helped so far. It does not stop me from continuing to up the doses, as prescribed, just in case. As he writes out the prescription he is clear: “Maybe one of these will reduce the pain but you can't expect more than that.”  

In other words, tough luck.

Meanwhile, my neurosurgeon has given me two last and final options. He can redo a procedure I had in 1980 that helped with the spontaneous pain (that could be triggered with the touch of a hair), until it failed 5 years later. Unfortunately, while doing the operation they removed bone in my neck. They took out way too much and my neck “fell down.” It is now held up with clamps in the front and back of the cervical spine, which are held in place by 12 pins.

Because of this, my new surgeon can’t go in where or the way he wants. It makes the outcome and risks much more unknown. There is only a 45% to 55% chance it will work, with a risk of paralysis among others. Almost equal odds.

The other option is worse, the odds are even: 50–50. Worse still, the operation is essentially psychosurgery. He would place a lesion in the frontal cortex of my brain. “You will still have pain, you'll just not perceive it as pain,” he explained.

So, what do I do? What do we do when faced with equally awful choices?

I honestly don't know.

I do know that learning to live with pain, what so many of us are told, is of no help when no one tells us how to do that. If they would, maybe “tough luck” would be an acceptable option.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of  “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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.

How Trump and Congress Can Champion Stem Cells

By A. Rahman Ford, Columnist

For the second straight year, President Trump has endorsed making life-saving treatments like stem cell therapies more available to more Americans.

In his 2017 Joint Address to Congress, Trump highlighted the case of Megan Crowley, a young woman whose father had to launch his own drug company to help treat her Pompe Disease.  Also in attendance that evening was Sarah hughes, who was forced to travel to Mexico to use her own stem cells to treat her systemic idiopathic juvenile arthritis.

In reference to both cases, the president lamented the pain and death caused by the “slow and burdensome approval process at the Food and Drug Administration” that “keeps too many advances … from reaching those in need.”  He argued that regulatory restraints at the FDA should be “slashed” so that more Americans could benefit from life-saving therapies.

President Trump is keeping up the pressure.  During this week's State of the Union address, he continued his theme of a patient-centered, less restrictive approach to medical treatment. 

He did so by voicing his clear support for “Right to Try” legislation, which would increase the medical options of the critically ill by helping them avoid the unduly burdensome and bureaucratic spider’s web of the FDA. 

In a seeming reference to Sarah Hughes and other stem cell medical tourists, Trump stated unequivocally that “patients with terminally conditions … should have access to experimental treatments immediately” and they “should not have to go from country to country to seek a cure.”  He then urged Congress to pass the Right to Try Act, so that Americans can get help “right here at home.”

How Right to Try Works

The language of the Right to Try legislation is simple, straightforward and offers protections for patients and manufacturers.  Under the Senate version, an “eligible patient” who has been diagnosed with a terminal illness may be prescribed an experimental drug or biological product to treat their illness, so long as the patient has a qualified physician certify that he or she has exhausted all other treatment options and is unable to participate in a clinical trial. The patient must also provide informed consent to the physician and the physician may not be compensated by the manufacturer of a treatment for certifying the patient.  The patient, physician and manufacturer must all agree on the treatment.

Furthermore, the medical product in question must have successfully completed a Phase 1 clinical trial and must be enrolled in an FDA clinical trial.  The treatment must be authorized by state law, which means that the state must have a Right to Try law – which 38 states currently have.

The manufacturers receive protection under Right to Try legislation, in that there can be no legal liability for injury that may result as a consequence of the medical product’s use, and adverse events that may occur during treatment will not negatively impact any eventual approval of the product by the FDA. 

In an overwhelming and increasingly rare bipartisan display (94-1), the Senate has already passed the Right to Try Act.  The House version is currently awaiting approval.

Critics Deny Democratic Choice 

Critics of Right to Try make several claims to undermine the expansion of choices it would bring to critically ill patients.  Some physicians and medical ethicists claim that the true goal of Right to Try is to weaken the FDA as the only objective and appropriate gatekeeper of drug approval and access.  Some also claim that the legislation is redundant because the FDA already fills this need through its expanded access program. 

Still other critics try to dissuade patients by surreptitiously noting that “scary” conservative and libertarian think tanks like Freedom Partners and Americans for Prosperity, which are partially funded by the Koch brothers, favor passage of Right to Try legislation.  These criticisms warrant thoughtful consideration, but are not substantive enough to overcome overarching concerns of patients literally dying from their pain.    

Ultimately, Right to Try and stem cell therapy are issues that embody the deepening and broadening of healthcare choice -- a choice that should be embraced by an informed American citizenry, a forward-thinking medical establishment and government agencies that must be by and for the people. 

Carefully curated expansions of choice -- that privilege the humane while also giving due consideration to patient protection – serve as the foundation of all truly democratic institutions.  The FDA should accept that it can better serve people by acceding some of its authority and become more lean and nimble in the process.  Bigger is not always better.

Right to Try will not solve all the problems associated with stem cell therapy.  There is no way to predict with any precision how the law will operate legally or logistically, whether for stem cell therapies or other drugs and medical products.  Additionally, the Trump administration must revisit and revise the FDA’s stem cell guidance, specifically its limits on stem cells which are harvested, processed and administered to the same person to relieve conditions such as chronic pain.    

However, for advocates of stem cell therapy and health choice in general, Right to Try is a step in the right direction.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania.

Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.  

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.