How the Opioid Crisis Has Changed

By Roger Chriss, Columnist

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

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

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

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

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

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

Tragically, similar success is lacking in the overdose crisis.

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

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

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

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

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

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

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

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

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

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

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

Should Gabapentin Be a Controlled Substance?

By Pat Anson, Editor

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

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

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

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

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

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

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

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

‘Snake Oil of the 20th Century’

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

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

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

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

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

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

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

Getting the Story Right About Opioids

By Pat Anson, Editor

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

There’s a fair amount of truth to that.

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

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

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

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

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

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

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

The Story of Mr. P

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

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

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

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

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

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

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

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

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.

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.

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.”

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. 

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.

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.  

High Dose Opioids Targeted Under New Medicare Rules

By Pat Anson, Editor

The Trump administration has proposed new rules that will make it harder for Medicare patients to obtain high doses of opioid pain medication. If adopted, critics say the regulations could force many high-dose pain patients to be abruptly tapered to lower doses, a risky procedure that could lead to severe pain and withdrawal symptoms, or even illegal drug use and suicide.

The rules proposed by the Centers for Medicare & Medicaid Services (CMS) would also make health insurers the final arbiters in deciding who gets high doses of opioid medication.

"We are proposing important new actions to reduce seniors' risk of being addicted to or overdoing it on opioids while still having access to important treatment options," said Demetrios Kouzoukas, CMS deputy administrator. “We believe these actions will reduce the oversupply of opioids in our communities."

Under the proposal for the 2019 Medicare Part D prescription drug program, a ceiling for opioid doses would be established at 90mg morphine equivalent units (MME).  Any prescription at or above that level would trigger a “hard edit” requiring pharmacists to talk with the insurer and doctor about the appropriateness of the dose.

Medicare officials claim the goal of the rule is to get patients, doctors and insurers to “engage in a dialogue” about the risks associated with opioids. But regardless of how that dialogue goes, ultimately the final decision on whether to override the hard edit would be left to insurers – known as plan sponsors.

"The trigger can only be overridden by the plan sponsor after efforts to consult with the prescribing physician," said Kouzoukas.

The 90mg MME ceiling was established in 2016 by the CDC’s much criticized opioid prescribing guidelines. Those “voluntary” guidelines were only meant as recommendations for primary care physicians, but have been widely adopted as rigid rules by other federal agencies, insurers, state regulators and prescribers.

High Dose Patients at Risk

CMS says 1.6 million Medicare beneficiaries met or exceeded opioid doses of 90mg MME for at least one day in 2016. Many suffer from chronic or intractable pain and have been on high doses for years.

“If this CMS proposal is adopted, it will accelerate an ongoing pattern of involuntary opioid tapers,” says Stefan Kertesz, MD, a practicing physician and professor of medicine at the University of Alabama at Birmingham School of Medicine. “I have great concern for today’s high dose patients, many of whom have complex disabilities. Their disabilities often reflect a combination of underlying physical disease, mental conditions, harm from the health care system and opioid dependence, even if those same opioids confer some degree of relief.

"Over the last year, I have received wave after wave of reports of traumatized patients, with outcomes that include suicidal ideation, medical deterioration, rupture of the primary care relationship, overdose to licit or illicit substances, and often enough, suicide.” 

Those suicides -- such as those of Bryan Spece and Jay Lawrence -- are rarely reported by the mainstream media or acknowledged by anti-opioid activists.

To reduce the risk of these “unintended consequences,” CMS would allow high dose patients to receive a temporary 7-day supply of opioids while they seek an exception to the 90mg MME rule. If approved, patients would then need to get a new prescription from their doctor. The 7-day supply would only be granted once.

Under the proposed rules, CMS would also create a new 7-day limit for initial prescriptions of opioids for acute, short-term pain. CMS would also start monitoring “high risk beneficiaries” who are prescribed opioids and “potentiator” drugs such as gabapentin (Neurontin) and pregabalin (Lyrica). Recent research has shown that combining the medications increases the risk of overdose.

CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.

Public comments on the proposals must be submitted by Monday, March 5, 2018. To submit comments or questions electronically, go to www.regulations.gov, enter the docket number “CMS-2017-0163” in search  and follow the instructions for submitting a comment. 

The 2019 proposed rule changes may viewed by clicking here.

Feds Target Doctors and Pharmacies in New Crackdown

By Pat Anson, Editor

Over the next few weeks, the Drug Enforcement Administration will step up investigations of pharmacies and doctors found to be dispensing or prescribing suspicious amounts of opioid pain medication.

The so-called “surge” -- announced by Attorney General Jeff Sessions – is the latest in a series of steps the Justice Department has taken to combat the opioid crisis.

“Over the next 45 days, DEA will surge Special Agents, Diversion Investigators, and Intelligence Research Specialists to focus on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of drugs,” Sessions said during a Tuesday speech to law enforcement officials in Louisville, KY.

“DEA collects some 80 million transaction reports every year from manufacturers and distributors of prescription drugs.  These reports contain information like distribution figures and inventory.  DEA will aggregate these numbers to find patterns, trends, statistical outliers -- and put them into targeting packages,” Sessions said.

"That will help us make more arrests, secure more convictions -- and ultimately help us reduce the number of prescription drugs available for Americans to get addicted to or overdose from these dangerous drugs.”

But that kind of data mining of opioid prescriptions -- without examining the full context of who the medications were prescribed for or why – can be problematic and misleading.

For example, the DEA last year raided the offices of Dr. Forest Tennant, a prominent California pain physician, as well as two pharmacies regularly used by his patients. Tennant only treats intractable pain patients, many from out-of-state, and often prescribes high doses of opioids and other prescription drugs  because of their chronically poor health. Some of his patients are in palliative care and near death.

Those important facts were omitted or ignored by DEA investigators, who alleged in a search warrant that Tennant had “very suspicious prescribing patterns” and was part of a drug trafficking organization.

“It’s not like he’s just giving out high doses of medication and running a pill mill, like they said. That to me was the most asinine statement in that whole search warrant,” said Riley Holder, a disabled pharmacist with intractable pain who is one of Tennant’s patients.

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

Last August, Sessions ordered the formation of a new data analysis team, the Opioid Fraud and Abuse Detection Unit, to focus solely on opioid-related health care fraud.  He also assigned a dozen prosecutors to “hot spots” around the country where opioid addiction is common. In November, Sessions ordered all 94 U.S. Attorneys to designate an opioid coordinator to help spearhead anti-opioid strategies in their district.

FBI to Target Online Pharmacies

Sessions this week also announced the formation of a new FBI investigative team, called the Joint Criminal Opioid Darknet Enforcement (J-CODE) unit, which will focus on shutting down illegal online pharmacies. Dozens of FBI agents and intelligence analysts are being assigned to J-CODE.  

“Criminals think that they are safe on the darknet, but they are in for a rude awakening. We have already infiltrated their networks, and we are determined to bring them to justice,” Sessions said. “The J-CODE team will help us continue to shut down the online marketplaces that drug traffickers use and ultimately that will help us reduce addiction and overdoses across the nation.”

As PNN has reported, the online pharmacy business is booming. As many as 35,000 online pharmacies are operating worldwide, and over 90 percent are not in compliance with federal and state laws.  Many do not require a prescription, and about half are selling counterfeit painkillers and other fake medications. About 20 illegal online pharmacies are launched every day.

A staff report last week to the U.S. Senate's Subcommittee on Investigations found that it was relatively easy to find and order prescription drugs online. Senate investigators used Google search to find dozens of websites offering illegal opioids for purchase, including fentanyl and carfentanil. They also identified seven individuals who died from fentanyl-related overdoses after sending money and receiving packages from an online seller.

“I’m thrilled this is something the U.S. government is prioritizing and is starting to pay attention to,” says Libby Baney, Executive Director of the Alliance for Safe Online Pharmacies (ASOP), an industry supported non-profit. “The Internet is part of the problem right now when it comes to the opioid epidemic and it should be part of the solution.”

Baney told PNN that when illegal online pharmacies are shutdown, they often reappear under new domain names and website addresses. Many are also located in foreign countries and are outside the reach of U.S. law enforcement.

“It’s a game of whack-a-mole in some respects,” said Baney.  

Last year the Justice Department announced the seizure of the largest dark net marketplace in history, a site that hosted over 200,000 drug listings and was linked to numerous opioid overdoses, including the death of a 13-year old.

Medicare Expands Opioid Monitoring After GAO Report

By Pat Anson, Editor

The General Accounting Office (GAO) – now known as the Government Accountability Office – was established by Congress in 1921 to act as an independent, nonpartisan watchdog of the federal government.  

“We provide Congress with timely information that is objective, fact-based, nonpartisan, nonideological, fair, and balanced. Our core values of accountability, integrity, and reliability are reflected in all of the work we do,” the GAO says in its mission statement. 

Fair and balanced? Not always – at least not when it comes pain patients and their medication.

Two months ago, PNN reported on a GAO audit that recommended the Centers for Medicare and Medicaid Services (CMS) greatly expand its monitoring of Medicare patients who receive high doses of opioid pain medication.  

Over 700,000 Medicare beneficiaries currently receive opioids in excess of 90mg morphine equivalent doses, and the GAO thinks it would be a good idea to have private insurers track these patients and their doctors to look for signs of “inappropriate prescribing.”

Critics say such a policy would have a chilling effect on many doctors, who already fear government sanctions for prescribing opioids.

FOIA Request Rejected

We were struck by a footnote in the GAO report, which indicated the agency had never consulted with pain sufferers, patient advocacy groups or professional organizations that represent prescribers while preparing its audit. But the GAO did reach out to insurers, regulators, law enforcement, addiction treatment specialists, anti-opioid activists, and surgeons who specialize in spinal injections:

"We interviewed officials from the largest six health care plan sponsors: Aetna, Cigna, CVS Health, Express Scripts, Humana, and United Health Group. We also interviewed 12 stakeholders that represent a range of perspectives on opioid use and prescribing patterns in Medicare: AARP, American Health Insurance Plans, American Society of Interventional Pain Physicians, Brandeis Prescription Drug Monitoring Program Training and Technical Assistance Center, Federation of State Medical Boards, National Association of Drug Diversion Investigators, National Association of Medicaid Directors, National Healthcare Antifraud Association, Pew Charitable Trust, Pharmaceutical Care Management Association, Physicians for Responsible Opioid Prescribing (PROP), and one expert on opioid abuse."

The GAO said it did not identify any of the “stakeholders” by name because the interviews were conducted on a not-for-attribution basis to encourage frank discussion. Pain News Network filed a Freedom of Information Act (FOIA) request to get the agency to disclose those names – which was quickly rejected.

“As an agency responsible to the Congress, GAO is not subject to FOIA,” Timothy Bowling, the GAO’s Chief Quality Officer, wrote to PNN. “Please be advised that while conducting the audit engagement above, GAO obligated itself not to disclose any names or identifiable information related to these stakeholder groups.”

This is certainly not the first time pain patients and pain management experts have been denied a seat at the table when federal decisions are made about pain care.

In 2015, the Centers for Disease Control and Prevention failed to consult with patients or practicing pain physicians when it drafted its opioid prescribing guideline. The CDC even refused to disclose who served on its expert advisory panel until it was threatened with a lawsuit.  

Patients and doctors were also excluded from a closed door meeting of the Healthcare Fraud Prevention Partnership -- an obscure federal advisory group – when it met in a 2016 "special session" to discuss Medicare's opioid prescribing policies. More recently, President Trump’s opioid commission released its final report without taking any public testimony from pain sufferers, patient advocates or pain management physicians.

“I find it very disturbing that federal agencies continue to ignore pain care providers and advocacy groups for people with pain when they formulate policies that very clearly will impact those parties. Again and again, they consult with parties that have a vested interest in reducing opioid prescribing regardless of the impact on people with pain," said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“It’s wrong, and everyone with a stake in pain management should demand that they start allowing us to sit at the table, rather than just to be on the menu.”

Medicare Tracking Opioid Prescriptions  

What became of the GOA report and its recommendations? Many are now being implemented by CMS.

In testimony before a House committee this month, a GAO official said CMS had agreed to start collecting data on all Medicare beneficiaries prescribed high dose opioids, as well as doctors who are “inappropriately and potentially fraudulently overprescribing opioids.”  

“A large number of Medicare Part D beneficiaries use potentially harmful levels of prescription opioids, and reducing the inappropriate prescribing of these drugs is a key part of CMS’s strategy to decrease the risk of opioid use disorder, overdoses, and deaths,” said Elizabeth Curda, Director of Health Care for GAO.

“Access to information on the risks that Medicare patients face from inappropriate or poorly monitored prescriptions, as well as information on providers who may be inappropriately prescribing opioids, could help CMS as it works to improve care.”

CMS is also considering rule changes for Part D prescription drug plans in 2019 that would designate most opioids as “frequently abused drugs,” and would require some Medicare beneficiaries to obtain their opioid prescriptions from prescribers and pharmacies selected by CMS.

Opioid Commission Member Calls Panel a ‘Charade’

By Pat Anson, Editor

The Trump Administration and Congress have so neglected the country’s opioid crisis that they have turned the work of the president's opioid commission into a "charade" and a "sham," according to one panel member.

In a wide ranging interview with CNN, former Democratic Rep. Patrick Kennedy lamented a lack of focus and funding the opioid crisis has received since President Trump declared the overdose and addiction epidemic a national public health emergency last October.

"This and the administration's other efforts to address the epidemic are tantamount to reshuffling chairs on the Titanic," said Kennedy.

"The emergency declaration has accomplished little because there's no funding behind it. You can't expect to stem the tide of a public health crisis that is claiming over 64,000 lives per year without putting your money where your mouth is."

PATRICK KENNEDY

Without funding and resources, Kennedy said he believes the opioid commission's work had become a charade.

"I do. I honestly do. It means nothing if it has no funding to push it forward.... this thing's a charade,”” he told CNN. "I have to be true to the way I feel. This is essentially a sham."

President Trump appointed the bipartisan panel in March to give him a list of recommendations to combat drug addiction and the overdose crisis. 

COMMISSION on combating drug abuse and the opioid crisis

After a series of public hearings, the commission released its final report in November, an ambitious list of over four dozen recommendations aimed at treating addiction, preventing overdoses, and further restrictions on opioid prescribing.

But since the report’s release, little money has been set aside by Congress or the administration to implement the panel’s recommendations, except to increase border security and detect illegal drugs.

Last week President Trump proposed cutting the budget of the White House Office of National Drug Control Policy – which oversaw the opioid commission’s work -- by 95 percent.  After a year in office, the president has yet to appoint a permanent director for the office, which currently has a 24-year old deputy chief of staff fresh out of college with no prior experience in management or drug control policy.

"Everyone is willing to tolerate the intolerable -- and not do anything about it," said Kennedy, who is recovering from alcohol and opioid addiction, and is a prominent mental health advocate.

“I'm as cynical as I've ever been about this stuff,” he said. “We've got a human addiction tsunami, and we need all hands on deck."

Bertha Madras, another member of the opioid commission, told CNN the panel has never received any direct feedback from Trump about its work. But she praised the selection of presidential advisor Kellyanne Conway as the key point person for the administration in dealing with the opioid crisis.

"That is really a very significant issue, bringing the implementation directly into the White House, as opposed to having intra-agency meetings," said Madras, a professor of psychobiology at Harvard Medical School. "Having been in government 10 years ago or so, I know how difficult it is to be able to generate change without having executive leadership behind you."

When asked by CNN about Kennedy's critique, she praised him for the "passion and depth he brings to the problem," but said it was premature for her to comment until she sees how much money is eventually allocated for the opioid crisis.