Heroin and Fentanyl Fueling Veteran Overdoses, Not Rx Opioids

By Pat Anson, PNN Editor

The U.S. Department of Veterans Affairs has taken a number of steps in recent years to reduce opioid prescribing for military veterans and their families. In 2015, the VA adopted the CDC opioid guideline before it was even finalized. Two years later, the agency adopted a clinical practice guideline for VA doctors that strongly recommends against prescribing opioids to patients for more than 90 days.

Both measures were intended to address “mounting concerns about prescription drug abuse and an overdose epidemic among veterans.”

But a new study has found that the “epidemic” of opioid overdoses among veterans is not fueled by prescriptions opioids – but by heroin, illicit fentanyl and other synthetic opioids obtained on the black market.

Researchers at the University of Michigan and VA Ann Arbor Healthcare System reported in the American Journal of Preventive Medicine that overdose deaths from all opioids increased by 65 percent for veterans from 2010 to 2016. But when then looked closer at prescription data on nearly 6,500 veterans who died, they found an unexpected trend.

"The percentage of veterans who had received an opioid pain prescription in the year before their opioid overdose death dropped substantially over this time period," says lead author Allison Lin, MD, an addiction psychiatrist at the VA Ann Arbor.

In 2010, half of the veterans who died of any opioid overdose had filled an opioid prescription in the three months before they died, and two-thirds had filled a prescription in the last year.

But by 2016, only a quarter of those who overdosed had filled an opioid prescription in the last three months, and 41 percent had done so in the past year.

At the same time, the death rate from heroin or from taking multiple opioids nearly quintupled, and the death rate from synthetic opioids such as fentanyl rose more than five-fold.

“Interventions on opioid overdose prevention have often focused on those receiving opioid prescriptions; if we're only screening for risk in that population, this shows we will miss a lot," said Lin. "We really have to think about opioid overdose prevention and substance use disorder treatment more broadly, to determine where the greatest unmet need is, increase treatment access and accessibility, and improve outcomes."

The VA provides health services to 6 million veterans and their families. Over half the veterans being treated at VA facilities suffer from chronic pain, as well as other conditions that contribute to it, such as depression and post-traumatic stress disorder.

A 2016 study of veterans found a strong link between heroin use and the non-medical use of prescription opioids. Having a long-term prescription for opioids to treat chronic pain was not found to be a significant risk factor for heroin use.

Forced Opioid Tapering: ‘The Next Great Experiment’

By Pat Anson, PNN Editor

Last month the Food and Drug Administration warned doctors not to abruptly discontinue or rapidly taper patients on opioid pain medication. The agency said it had received reports of “serious harm” to patients who’ve been suddenly cutoff, including withdrawal symptoms, uncontrolled pain, psychological distress and suicide.  

A new study published in the Journal of Substance Abuse Treatment shows just how common the practice is. And how millions of pain patients are being subjected to a public health experiment with hardly anyone keeping track of what happens to them.

“The United States went through a great ‘experiment’ of expanding treatment of pain with opioids which has proved to be disastrous for public health. We have entered the next great ‘experiment’ of discontinuing opioid medications among the millions of Americans who are currently taking them,” said lead author Tami Mark, PhD, senior director of behavioral health at RTI International, a non-profit research institute.

“Little is known about how many individuals are tapering off opioid medications, whether observed tapering follows any… guidelines, and the extent to which rapid tapering is associated with negative consequences.”

Mark and her colleagues looked at medical and pharmacy claims for nearly 500 Medicaid patients in Vermont who had high doses of opioid medication discontinued from 2013 to 2017.

All of the patients were prescribed a daily dose of at least 120 MME (morphine milligram equivalent) and over half had been on that high dose for over a year. 

Although most clinical guidelines recommend a “go slow” approach to opioid tapering – especially for patients on high doses – only 5 percent of the Vermont patients had a tapering period longer than 90 days. The vast majority (86%) were rapidly tapered in 21 days or less, including about half who were cut off from opioids without any tapering.

The Centers for Disease Control and Prevention recommends that patients on opioids be tapered only 10% a week, with even slower tapers of 10% a month for long-term users. Had those guidelines been applied in Vermont, most tapers would have taken up to a year to complete.

Half of Tapered Patients Hospitalized

What happened to the patients who were cut off? Nearly half were hospitalized or had an emergency room visit for an “opioid-related adverse event” -- a medical code that can mean anything from severe withdrawal symptoms to acute respiratory failure. For tapered patients, the risk of being hospitalized was reduced by 7% for each additional week of tapering.

Researchers don’t know how many of the discontinued patients committed suicide or how many were referred to addiction treatment. Notably, less than one percent received medication assistance treatment (MAT) such as Suboxone.

The study did not look at why patients were taken off opioids or who initiated the discontinuation. But researchers believe some of the rapid discontinuations “may be due to a breakdown in the clinical relationship between physicians and patients” – suggesting the patients were forcibly tapered or abandoned by their doctors.

In its warning to doctors, the FDA strongly recommends that patients not be forcibly tapered and that patients and doctors should jointly agree to a tapering plan.

“Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients,” the FDA said.

Forced Tapering Widespread

How many patients have been forcibly tapered or discontinued is unclear, but it probably runs in the millions. A recent report from IQVIA found that there were 75 million fewer opioid prescriptions filled last year compared to 2014, with the biggest decline in high dose prescriptions. 

In PNN’s recent survey of nearly 6,000 pain patients, over 80 percent said they had been taken off opioids or had their dose reduced since the CDC released its controversial opioid guideline in 2016. Many were turning to other substances – both legal and illegal – for pain relief. And nearly half said they had considered suicide because their pain is poorly treated.

“I have been forced to taper to 90 MME. I had been stable and functional for 10 years at 135 MME. Now I can no longer work, and can barely take care of my children. I am considering suicide because my pain is unbearable,” one patient told us.

“I have been forcibly tapered by more than half and my pain is not being relieved at this dose. I am now unable to work or care for my children,” another patient wrote. “I live in constant anxiety (which worsens my pain) that I will be abandoned, refused any pain management, or reduced to a dose so low that taking my own life is the only way to escape the pain.”

“My forced taper was a little over a year ago. Before that I lived a small but functional life on high dose opioids. I took the same dose, from the same doctor for over a decade. Then I was forced off of 75% of my dose,” said another patient. “Once we got down to my current dose the medication was no longer enough to control my pain. I now live a tiny, nonfunctional life. I spend all my time in bed watching TV. I never leave the house. Showers are my worst enemy. And I am lucky. I wasn’t abandoned by my doctor.”

A noted critic of opioid prescribing calls reports like these exaggerations. Andrew Kolodny, MD, the Executive Director and founder of Physicians for Responsible Opioid Prescribing (PROP), told Stateline that the number of doctors who are inappropriately tapering patients is likely very small and should not be blamed on the CDC.

"We have a very real problem in this country. But the CDC guidelines didn't cause it," Kolodny said. "The problem is that millions of Americans have been put on round-the-clock opioids at very high doses and for reasons that doctors now realize were not appropriate.

"What the FDA needs to tell doctors is that because it is so excruciating to come off of opioids, they need to be very selective about who they put on them.”

In a series of Tweets two years ago, Kolodny said patients on high doses should be forcibly tapered “even if patient refuses” and challenged assertions that forced tapering was risky and widespread.

Now Kolodny says he sympathizes with patients but claims they are being manipulated.

“Their emotions are real. But they’re being effectively manipulated to controversialize the CDC guidelines,” he told Stateline.

Many of Kolodny’s colleagues disagree. Over 300 healthcare professionals warned in a joint letter last year that forced opioid tapering has led to “an alarming increase in reports of patient suffering and suicides” and called for an urgent review of tapering policies at every level of healthcare.

“This is a large-scale humanitarian issue,” the letter warns. “New and grave risks now exist because of forced opioid tapering.” 

Oregon Drops Opioid Tapering Plan

By Pat Anson, PNN Editor

An Oregon health panel has tabled a controversial plan that would have forced tens of thousands of Medicaid patients with neck and back pain to stop taking opioid medication. The Health Evidence Review Commission (HERC) voted unanimously to wait for additional studies to be completed later this year, which effectively delays any change in medical coverage under the Oregon Health Plan until 2022.

The forced tapering plan drew nationwide criticism from pain sufferers, patient advocates and pain management experts, who said it would “exacerbate suffering for thousands of patients.”

"Pain is complicated and different for everyone," said HERC chairman Kevin Olson, MD, in a statement. "We heard loud and clear that pain treatment and opioid tapering should be individualized based on the patient-clinician relationship. I am pleased that we were able to align the neck and back coverage with these principles."

If a patient with any chronic pain condition is not doing well with an opioid taper, HERC said the tapering should stop without consequence to the prescriber or patient.

But patient advocates say some doctors have already implemented HERC’s forced tapering proposal without waiting for it to be finalized.

“Many patients across Oregon have already suffered tapering from their opiate pain management or have been dropped by their physician as a result of this policy. Those patients who have already been affected deserve proper treatment for their medical conditions and must have their previous pain management regiments and care reinstated,” said Amanda Siebe, a pain patient and disabled activist who recently announced she was running for Congress in Oregon’s 1st congressional district.

“It's time HERC made up for the damage they've done to this community over the last 2 years, and give us the proper care and coverage we deserve to maintain functionality and quality of life. This fight won't be over for us until all patients are able to receive the pain management, care, and coverage they need and deserve.”

The HERC also voted unanimously to continue not covering treatment for five common chronic pain conditions, citing a lack of evidence on the effectiveness of any therapy, including opioids. The five conditions are chronic pain caused by trauma, post-surgical chronic pain, chronic pain syndrome, fibromyalgia and “other chronic pain.”

Patients advocates had supported a plan to cover those condition, not only with opioid therapy, but with alternative treatments such as physical therapy, acupuncture and yoga.

“The conditions being discussed are valid conditions, and I think they’re in need of medical treatment options. I think that opioids should be a part of those options,” Wendy Sinclair, a pain patient and co-founder of the Oregon Pain Action Group told the Bend Bulletin. “Doctors and patients need to work together and have those options available.”

HERC’s decision to reverse course on tapering was a significant and rare victory for the pain community, which rarely gets a set at the table or is listened to when political and regulatory decisions are made about opioid medication.

Last year over a hundred pain management experts signed a letter to HERC warning that its tapering plan would have been the most restrictive in the U.S. and was unsupported by treatment guidelines. That warning was recently echoed by the Food and Drug Administration, which said rapid tapering and forced discontinuation of opioids was causing “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.

Is Tramadol Just as Addictive as Other Opioids?

By Pat Anson, PNN Editor

Patients recovering from surgery who take the opioid tramadol have a slightly higher risk of prolonged use than those receiving oxycodone or other short acting opioids, according to a large Mayo Clinic study.

Prescriptions for tramadol – which is sold under the brand names Ultram and ConZip – have been increasing because it is widely perceived as a “safer” opioid with less rick of addiction. The new study, published in The BMJ, appears to debunk that claim, at least for surgery patients.

Mayo Clinic researchers looked at health data for over 350,000 patients who were prescribed opioids after undergoing 20 common surgeries in the U.S. between 2009 and 2018. A little over 7% of the patients were still refilling opioid prescriptions 90-180 days later. When the researchers dug a little deeper into the data, they found that patients taking tramadol had a 6 percent higher risk of prolonged use compared to other opioids.  

"This data will force us to reevaluate our postsurgical prescribing guidelines," says lead author Cornelius Thiels, DO, a general surgery resident in Mayo Clinic School of Graduate Medical Education. "While tramadol may still be an acceptable option for some patients, our data suggests we should be as cautious with tramadol as we are with other short-acting opioids."

Tramadol is a synthetic opioid that was classified as a Schedule IV controlled substance by the Drug Enforcement Administration in 2014, a category that means it has a low potential for abuse. That same year, hydrocodone was rescheduled as a Schedule II drug, meaning it has a high potential for abuse.

Many patients who were taking hydrocodone were switched to tramadol as a result of the rescheduling.

Over half (53%) of the patients in the Mayo Clinic study were prescribed hydrocodone, about a third (37.5%) received oxycodone (also a Schedule II drug) , and only 4% received tramadol.

"We found that people who got tramadol were just as likely as people who got hydrocodone or oxycodone to continue using opioids past the point where their surgery pain would have been expected to be resolved," said senior author Molly Jeffery, PhD, the scientific director of research for the Mayo Clinic Division of Emergency Medicine. "This doesn't tie to the idea that tramadol is less habit forming than other opioids."

Jeffery and his colleagues say the DEA and FDA should consider reclassifying tramadol to a level that better reflects the risk of prolonged use.

"Given that tramadol is not as tightly regulated as other short-acting opioids, these findings warrant attention," said Thiels.

In 2017, the FDA banned the use of tramadol in children under the age of 12, citing a handful of cases where children died or had serious breathing problems after using the drug.

Tramadol was classified as a Schedule 3 drug in the United Kingdom in 2014. It is an unscheduled drug in Canada, but Health Canada is currently reviewing its status.

Audit Details Misuse of Funds at U.S. Pain Foundation

By Pat Anson, PNN Editor

It’s been over a year since serious “financial irregularities” were uncovered at the U.S. Pain Foundation and former CEO Paul Gileno was forced to resign under pressure. But the Connecticut based non-profit is still dealing with legal and financial fallout from years of nepotism, self-dealing and lax oversight by its management and board of directors under Gileno’s leadership.

A newly released audit of U.S. Pain and its 2018 tax return indicate that Gileno misappropriated over $2,055,000 from the charity from 2016 to 2018. The board did not discover the financial irregularities until April 2018, when it hired an auditor and attorney to investigate.

‘The findings were clear that the former president had engaged in unauthorized transactions involving the misuse of assets of the organization. The Board demanded and received the former CEO’s immediate resignation on May 29, 2018, and shortly thereafter reported the matter to federal authorities,” the audit states. “The criminal investigation is still ongoing into the former president’s activities.”

In addition to the federal investigation, PNN has learned that the Connecticut Attorney General’s office is planning to seek a court order to prohibit Gileno from ever handling charitable funds again.

U.S. Pain is providing few details on how Gileno was able to misappropriate over $2 million from the charity over a three year period. The misused funds were reported to the IRS as “excess benefit transactions,” a broad category that includes unauthorized compensation, reimbursement for Gileno’s personal expenses, and payments to Gileno’s family members for unspecified work.

In addition to the $32,537 that Gileno received in wages for roughly five months of work in 2018, he collected over $166,000 in excess benefits last year. The latter amount includes a $36,000 payment to an unidentified company owned by Gileno. It is not clear what the payment was for.

PAUL GILENO

Gileno’s wife, sister and step-daughter were also on the charity’s payroll, collecting nearly $71,000 in wages in 2018. It is not clear what work they did. Gileno’s sister also received an unspecified amount of severance pay and maternity leave, according to the tax return.

The auditor also reported that U.S. Pain has been unable to recover any money from a $100,000 investment in SMJ Homes, a real estate business owned by Gileno’s brothers. A promissory note from the company was due in February 2019, but has not be repaid.  

Poor Business Decisions

In addition to the questionable payments to Gileno and his family, the audit and tax return show that U.S. Pain entered into a series of poor business decisions.

In 2016, U.S. Pain launched an “unrelated bakery business” that Gileno, a former caterer, established to “further the general mission” of the charity. Nothing in U.S. Pain’s mission statement says anything about a bakery.

The bakery was unprofitable from the start, reporting a net loss of nearly $70,000 in 2017. The board voted to liquidate the business last year at a cost of over $72,000 and recently agreed to pay another $23,900 to settle lease obligations for the bakery. In all, over $165,000 in charitable funds were wasted on the failed enterprise.

After Gileno’s departure, the board agreed to forfeit a non-refundable deposit of $50,000 that Gileno authorized in a failed attempt to purchase PainPathways magazine.

The board also scrapped a $2.5 million prescription co-pay program with Insys Therapeutics, a controversial drug maker whose founder and four former executives were recently convicted of racketeering. U.S. Pain said it would no longer accept funding from Insys, but rather than return leftover funds the board has kept $200,000 from the company in an escrow account.

Dealing with all of these legal and financial issues has been costly. According to its tax return, U.S. Pain paid nearly $514,000 for legal services, accounting and penalties in 2018 — nearly a quarter of its revenue for the year.

Gileno: “I Never Misled Them”

How could the self-dealing and financial irregularities go undetected for so long? Interim CEO and board chair Nicole Hemmenway said in a statement last December that Gileno “repeatedly misled and concealed information from the Board of Directors and staff.”

But Gileno, who has admitted taking money from U.S. Pain for his own personal use, maintains that he kept the board informed. “I never misled them. They were part of U.S. Pain for over 10 years and I talked with them daily. Nicole and I were close like a brother and sister and I never hid one thing,” Gileno told PNN last year. 

Gileno did not respond to a request for comment for this story. Neither did Hemmenway. A spokesperson for U.S. Pain said in an email the tax return and audit “constitutes our public statements on these matters.”

The charity’s 2018 tax return was filed on time, but its 2016 and 2017 returns were delinquent and filed late in 2018. They indicate there was no real oversight of Gileno by the board until last year.

“The former President/CEO controlled the board process. The records maintained under his leadership list the officers and directors… but contain no evidence that election of officers and directors occurred,” the tax returns said.

The audit indicates that U.S Pain “rents its main office from the father in law of an employee” who is not identified. Public records for the city of Middletown, CT indicate the building is owned by Ottavio Monarca, who is the father-in-law of Lori Monarca, U.S. Pain’s Executive Office Manager. Rent of $25,000 was paid for the office in 2018 and the lease continues until 2020.

Hemmenway was paid a salary of $71,750 in 2018. The other two board members, Wendy Foster and Ellen Lenox Smith, a former PNN columnist, did not receive any compensation. Smith’s daughter-in-law, Shaina Smith, was paid a salary of $76,700 in 2018 as Director of State Advocacy for U.S. Pain.

Despite all of these expenses and business losses, U.S. Pain appears to be in fairly good financial shape compared to other charities. It received over $1.8 million in donations and grants in 2018, and ended the year with over $454,000 in cash — an enviable position for most non-profits, which often struggle to raise money.

Major corporate donors to U.S. Pain include Abbvie, Amgen, Lilly, Sanofi, Novartis, Teva, Abbott, Pfizer and other pharmaceutical companies.   

Sen. Ron Wyden (D-OR), the ranking member of the U.S. Senate Finance Committee, sent a letter last December to Hemmenway asking a series of detailed questions about the charity’s relationship with Insys  and other drug makers. According to the senator’s office, Wyden has still not received a full response.  

“A substantial amount of information that Senator Wyden requested from the U.S. Pain Foundation remains outstanding. Staff continues to communicate with the foundation in order to fully understand the financial relationship and contacts it has had with pharmaceutical manufacturers, including Insys, and its compliance with applicable federal laws,” a Wyden spokesman said in a statement to PNN.

Record Decline in Opioid Prescriptions

By Pat Anson, PNN Editor

Often lost in the debate over opioid medication is that prescriptions for the drugs have been falling for years — a trend that appears to be accelerating. The volume of prescription opioids dispensed in the U.S. last year fell 17 percent, the largest annual decline ever recorded, according to a new study by the health analytics firm IQVIA. Opioid prescriptions have dropped 43% since their peak in 2011.

“Decreases in prescription opioid volume have been driven by changes in clinical use, regulatory and reimbursement policies and legislation, all of which have increasingly restricted prescription opioid use since 2012,” the report found.

The biggest drop was in high dose opioid prescriptions of 90 MME (morphine milligram equivalent) or more, which account for 43% of the decline. Low dose prescriptions of 20 MME or less have remained relatively stable, falling just 4 percent.

While opioid prescriptions have fallen significantly, addiction and overdose rates continue to soar, fueled in large part by illicit fentanyl, heroin and other black market opioids.

“We saw many more people receiving medication-assisted treatment (MAT) for opioid addiction. Our research shows new therapy starts for MATs increased to 1.2 million people in 2018, nearly a 300 percent increase compared with those seeking addiction help in 2014,” said Murray Aitken, IQVIA senior vice president.

“This is an important indicator of the effects of increased funding and support for treatment programs to address addiction.”

A recent report by the Bipartisan Policy Center estimates the federal government spent nearly $11 billion since 2017 subsidizing the addiction treatment industry, much of it spent on MAT drugs such as buprenorphine (Suboxone).

Drug maker Indivior recently reported the buprenorphine market had double digit growth in the first quarter of 2019, and that “growth continues to be driven primarily by Government channels.”

Hydrocodone Prescriptions Drop

For the 7th consecutive year, prescriptions fell for hydrocodone-acetaminophen combinations such as Vicodin, Lortab and Norco. Once the #1 most widely dispensed drug in the nation, hydrocodone now ranks fifth, behind drugs used to treat thyroid deficiency, high blood pressure and high cholesterol.

Only 68 million prescriptions for hydrocodone were dispensed last year, half the number that were filled in 2011.

U.S. HYDROCODONE PRESCRIPTIONS (MILLIONS)

Source: IQVIA

Due to fears about addiction and overdose, hydrocodone was reclassified by the DEA as a Schedule II controlled substance in 2014, requiring new prescriptions for every refill.

“My hydrocodone has been cut in half and my pain is out of control. I feel like a criminal, like I am committing a crime each time I pick up my prescription. I now have to visit my doctor once a month to receive my script,” one patient told us.

“I was prescribed hydrocodone over the last couple of decades for severe chronic pain with very positive effects. Now I am unable to carry out a lifestyle for a man my age, I'm basically done/finished.  My way of life is over,” a disabled veteran wrote.

“Stop denying the patients that have real pain. I don’t use it to get high. Hydrocodone is the only thing that has helped my back pain. I’ve tried a lot of things but nothing helps. It frees me of enough of the pain that I can function like a normal person,” another patient said.

The shift away from hydrocodone and other opioids has benefited pharmaceutical companies that make non-opioid medications such as Neurontin (gabapentin) and Lyrica (pregabalin).  Prescriptions for gabapentin reached 67 million last year – nearly the same as hydrocodone.

These trends have yet to show much benefit for pain patients, who increasingly report their pain is poorly treated. In a recent PNN survey of nearly 6,000 patients, over 85% said their pain and quality of life are worse since the release of the CDC opioid prescribing guideline. One in five say they are hoarding opioid medication because they fear losing access to it in the future.

Drug Diversion Widespread in Healthcare Facilities

By Pat Anson, PNN Editor

The Drug Enforcement Administration recently completed another National Prescription Drug Take Back Day, collecting over 468 tons of unused or expired medications. The idea is to get risky drugs – particularly opioids – out of medicine cabinets before they wind up on the streets.

“The current opioid crisis continues to take too many lives, and many people get their first pills to abuse from the home medicine cabinet,” said DEA New Jersey Special Agent in Charge Susan Gibson.

But the DEA’s Take Back program overlooks a growing problem in the healthcare industry: Opioid medications are increasingly being stolen before they even reach home medicine cabinets.

According to a new report by the healthcare analytics firm Protenus, over 47 million doses of medication were stolen in 2018 by doctors, nurses, pharmacists and other healthcare workers, an increase of 126% from the year before. Opioids were involved in 94% of the incidents, with oxycodone, hydrocodone and fentanyl the most common drugs stolen.

“For both doctors and nurses, the high stress of the profession, long shifts, fatigue, physical and emotional pain, along with easy access to controlled substances, contribute to why they might divert medications,” the report found.

“Drug diversion poses a great deal of harm to patients because it puts them at risk of being treated by care providers working under the influence of controlled substances as well as receiving the incorrect amount or type of medications.”

Among the incidents cited in the report are a Texas nurse stealing opioid medication from elderly patients and a Maryland pharmacist filling bogus opioid prescriptions in return for sexual favors. According to Protenus, the average amount of time it took to discover a case of healthcare drug diversion was 22 months, giving diverters plenty of time to continue their thefts and cover their tracks.

To combat in-house drug diversion, Protenus recommends that hospitals, pharmacies, nursing homes and other healthcare providers establish drug monitoring programs – similar to those used for patients – and educate their employees about detecting and preventing diversion.

“Drug diversion occurs in virtually every hospital and health system in America, but many are in denial that it is happening in their own organization,” said Russ Nix, Director of Drug Diversion Prevention at MedStar Health. “Very few resources exist today on how to identify and combat drug diversion, and what’s out there is siloed.”

Nix belongs to the advisory board of Healthcare Diversion Network, a new non-profit that has an online portal where healthcare employees can report drug thefts anonymously. The goal is to collect data and raise awareness about drug diversion in healthcare facilities. 

“I was really shocked when we put our initial database together at how many of those thefts were out of hospitals.”

— Tom Knight, Healthcare Diversion Network

“I think thefts out of home medicine cabinets happen, but I also know that thefts out of healthcare systems and hospitals happen,” said Tom Knight, Chairman of the Healthcare Diversion Network. “Many of those thefts are for self-use, where the person stealing is going to consume them themselves. But sadly, many of those thefts are where the person is planning to distribute them, typically for profit on the street illegally.

“I was really shocked when we put our initial database together at how many of those thefts were out of hospitals. There are numerous cases where people working in hospitals stole hundreds of thousands of doses that were sold on the street for years before they were eventually caught.”

Knight says about 10 percent of all healthcare workers are stealing opioids and other controlled substances. He told PNN there is no good data to indicate how much of the stolen medication sold on the street comes from medicine cabinets and how much comes from healthcare facilities or the drug distribution system.

“Pretty much anywhere they exist they’re being stolen. We’re trying to raise the visibility, particularly on the part of the healthcare facilities,” he said.

The Prescription Opioid Crisis Is Over

By Roger Chriss, PNN Columnist

In a very real sense, the prescription opioid crisis is over. But it didn’t end and we didn’t win. Instead, it has evolved into a broader drug overdose crisis. Opioids are still a factor, but so is almost every other class of drug, whether prescribed or sourced on the street.

The main players in the crisis now are illicit fentanyl, cocaine and methamphetamine. The vast majority of fatal overdoses include a mixture of these drugs, with alcohol and cannabis often present, and assigning any one as the sole cause of death is becoming tricky.

Connecticut Magazine recently reported on rising fentanyl overdoses in that state. According to the Office of the Chief Medical Examiner, fentanyl deaths in Connecticut spiked from 14 in 2012 to 760 in 2018. Fentanyl was involved in 75% of all overdoses last year, often in combination with other drugs

Meanwhile, overdoses involving the most widely prescribed opioid — oxycodone — fell to just 62 deaths, the lowest in years. Only about 6% of the overdoses in Connecticut were linked to oxycodone.

Similar trends can be seen nationwide, mostly east of the Mississippi. Opioids still play a major role in drug deaths, with the CDC reporting that about 68% of 70,200 drug overdose deaths in 2017 involving an opioid. But more than half of these deaths involved fentanyl and other synthetic opioids obtained on the black market.

According to the National Institute on Drug Abuse, overdoses involving prescription opioids or heroin have plateaued, while overdoses involving methamphetamine, cocaine and benzodiazepines have risen sharply.

In other words, deaths attributable to prescription opioids alone are in decline. Deaths attributable to fentanyl are spiking, and deaths involving most other drug class are rising rapidly. The CDC estimates that there are now more overdoses involving cocaine than prescription opioids or heroin.

Moreover, the crisis is evolving fast. At the American College of Medical Toxicology’s 2019 annual meeting, featured speaker Keith Humphreys, PhD, remarked that “Fentanyl was invented in the sixties. To get to 10,000 deaths took 50 years. To get to 20,000 took 12 months.”

In fact, provisional estimates from the CDC for 2018 suggest we have reached 30,000 fentanyl deaths. And state-level data show few signs of improvements for 2019.

Worryingly, methamphetamine use is resurgent. And cocaine is “making a deadly return.”  Illicit drugs are also being mixed together in novel ways, with “fentanyl speedballs” – a mixture of fentanyl with cocaine or meth – being one example.

Drug Strategies ‘Need to Evolve’

The over-emphasis on prescription opioids in the overdose crisis has led to an under-appreciation of these broader drug trends. Researchers are seeing a need for this to change.

“The rise in deaths involving cocaine and psychostimulants and the continuing evolution of the drug landscape indicate a need for a rapid, multifaceted, and broad approach that includes more timely and comprehensive surveillance efforts to inform tailored and effective prevention and response strategies,” CDC researchers reported last week. “Because some stimulant deaths are also increasing without opioid co-involvement, prevention and response strategies need to evolve accordingly.”   

It is now common to hear about the “biopsychosocial” model for treating chronic pain – understanding the complex interaction between human biology, psychology and social factors. This same model has a lot to offer substance use and drug policy.

Substance use and addiction involve a complex interplay of genetic and epigenetic factors combined with social and cultural determinants. Treatment must be more than just saying no or interdicting suppliers. At present, medication-assisted therapy for opioid use disorder remains hard to access. And other forms of addiction have no known pharmacological treatment.

Addressing the drug overdose crisis will require not only more and better treatment but also increased efforts at harm reduction, decriminalization of drug use, improvements in healthcare, and better public health surveillance and epidemiological monitoring. Further, the underlying social and cultural factors that make American culture so vulnerable to addiction must be addressed.

None of this is going to be easy. Current efforts are misdirected, making America feel helpless and look hapless. Novel and possibly disruptive options may prove useful, from treating addiction with psychedelics to reducing risks of drug use through safe injection sites and clean needle exchanges.

We are long past the prescription opioid phase of the crisis, and are now in what is variously being called a “stimulant phase” and a “poly-drug phase.” Recognition of the shape of the drug overdose crisis is an essential first step toward changing its grim trajectory.

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.

Is the DEA Overreaching Its Authority?

By Lynn Webster, MD, PNN Columnist 

The U.S. Department of Justice (DOJ) does not have the legal authority to determine which health care activities constitute a “legitimate medical purpose.” However, an increasing number of prescribers have been subjected to DOJ criminal investigations that operate under an expanded interpretation of federal law.

In 1970, Congress passed and President Nixon signed into law the Controlled Substances Act (CSA). In its broadest sense, the CSA regulates every aspect of controlled substances, from production to delivery, distribution, prescribing, possession and use. The CSA’s impact is far-reaching, touching many different sectors of our society, including healthcare, pharmaceuticals, law enforcement, politics, and state and federal judiciaries.

According to the CSA, a prescription for a controlled substance “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” This statutory language is at the root of the issue. But who decides what is a legitimate medical purpose?

The Drug Enforcement Administration (DEA) is the branch of the DOJ that is tasked with enforcing the controlled substances laws and regulations of the United States.

In the context of trying to address the opioid crisis, the DEA has taken a proactive approach in determining which medical practices have a legitimate medical purpose and which do not. This hands-on approach is in direct contravention with the CSA. 

The DEA is effectively preempting state law as it relates to the regulation of controlled substances. In Gonzales v. Oregon, the U.S. Supreme Court ruled in 2006 that the authority to determine a legitimate medical purpose rests with state governments.

This means it is state lawmakers, not federal officials, who should regulate the practice of medicine. Medical boards are established by the authority of each state to protect the health, safety and welfare of patients through proper licensing and regulation of physicians and other practitioners.

If a doctor engages in an obviously nefarious activity, such as selling or trading prescriptions for sex or money, then that doctor is not in any way prescribing for a legitimate or legal medical purpose under the CSA. Remedies for this conduct would be within the authority of the DOJ, as well as state regulators.

The key phrases -- "legitimate medical purpose" and "in the usual course of a professional practice" -- are not defined in the CSA. This omission, unfortunately, has invited conjecture about the meaning of the phrases in recent years. The only way the phrase "legitimate medical purpose" would have any legal meaning would be if the concept of an "illegitimate medical purpose" were defined by the CSA -- and it is not.

Moreover, the words "legitimate" and "medical" are redundant. The practice of medicine is inherently legitimate, according to the CSA. The phrase "legitimate medical purpose" can be reduced to "medical purpose" without changing its meaning.

Any practice that is medical is legitimate and should be deemed consistent with the CSA regulation. The CSA, in other words, precludes the possibility that doctors who prescribe high doses of opioids have behaved criminally based only on the level of doses they prescribe.

Standard of Care

The DOJ is now using deviation from the “standard of care” to determine whether or not practitioners have a legitimate medical purpose to prescribe opioids. A standard of care is generally considered the customary or usual practice of the average physician.

In an attempt to address the opioid problem, the DOJ has hired medical experts who claim that any deviation from standard of care amounts to practicing without a legitimate medical purpose. In some instances, the government's experts have even used the CDC opioid guideline’s dose recommendation as a test of whether or not the prescribing of opioids has a legitimate medical purpose.

Using deviations from "standard of care" as criteria for compliance with the CSA is in direct conflict with the Supreme Court ruling in Gonzalez v Oregon, which found that the Attorney General “is not authorized to make a rule declaring illegitimate a medical standard for care and treatment of patients that is specifically authorized under state law.”

Even substandard treatment by providers is not necessarily criminal behavior and should rarely involve prosecution by the DOJ. This is supported by a 1983 statement in a DEA newsletter that declares acts of prescribing or dispensing controlled substances lawful when they are done within the course of a provider’s professional practice. Even if a physician's behavior reflects the grossest form of medical misconduct or negligence, it is nevertheless legal.

The information provided in the newsletter isn't an opinion. It's the law.

Unquestionably, prescribers should be held to a high standard of care at all times. However, it is the responsibility of state medical boards to hold them to that standard. It is not the DOJ's role to determine the quality or boundaries of the practice of medicine.

 Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

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.

Cancer Patient's Rite Aid Video Goes Viral

By Pat Anson, PNN Editor

April Doyle was frustrated and angry when she left a Rite Aid pharmacy Monday in her hometown of Visalia, California. A pharmacist there had once again refused to fill her prescription for opioid pain medication, so she got into her car and tearfully recorded a video that she uploaded to Twitter.

“I’m frustrated and that’s why I’m crying,” Doyle said, looking into her cell phone camera. “I’ve had a hard time getting my pain pills filled from them.”

Doyle’s story is a familiar one to millions of pain sufferers, who often have trouble getting their opioid prescriptions filled at pharmacies across the country. But her story is a bit different. The 40-year old single mom has Stage 4 terminal breast cancer that has metastasized into her lungs, spine and hip.  Doyle’s oncologist wrote a prescription for Norco — an opioid medication — to relieve some of her pain.  

“And when you have metastatic cancer in your bones, you need it.  Because sometimes the pain is so much you can’t even function. And I just want to function. I want to be able to go to work and I want to be able to sleep. And I want to be able to do things with my child.  I just want it not to hurt all the time,” Doyle said.

Within days, Doyle’s 6-minute video would go viral on Twitter and Facebook, where it’s been viewed over 200,000 times.  She’d also get apologies from a Rite Aid vice-president, the store manager and the pharmacist who refused to fill her prescription.

Doyle was no stranger at that Rite Aid store. It’s right around the corner from her house and she’s been shopping there for 20 years. It’s where she’s been getting her prescriptions filled for chemotherapy, anti-depressants and anti-nausea drugs — all written by her oncologist. But Rite Aid always seemed to have trouble filling that prescription for Norco. 

“I have to take 20 pills a day just to stay alive,” Doyle explains in the video. “Every time I take my pain pill prescription there, they give me the runaround. They don’t have enough in stock or they need me to come back tomorrow because they can’t fill it today. Or something stupid. It’s always something and it’s always some stupid excuse.”

Federal and state prescribing guidelines – and those of insurers – specifically exempt cancer pain from restrictions on opioid medication.  But some cancer patients still get turned away at pharmacies. According to Doyle, the Rite Aid pharmacist told her he was worried about being fined or even losing his job if he filled her opioid prescription.   

Some of that caution is understandable. Rite Aid and other major pharmacy chains were recently added as defendants in opioid lawsuits filed by the firm of Simmons Hanly Conroy. In the current climate of opioid hysteria and litigation, every step of the drug supply chain, from manufacturers to wholesalers to retailers is under scrutiny. Billions of dollars are at stake. Caught in the middle are pharmacists and patients like April Doyle.

“It’s not right. I’m not a criminal. I’m not a drug addict. I don’t even take them as often as my doctor says to take them. It’s not fair,” she said.

Astonished at Reaction

Doyle has been shocked at the response her video has gotten from the pain community. And surprised at how common her story is. Hundred of people left comments on Doyle’s Facebook page after watching her video.

“Stop giving your money to Rite Aid! You deserve dignity and great customer service,” one supporter wrote. “This whole opioid epidemic is making it impossible for those who medically need the meds. We all have our own story to share. This has to stop!”

“It’s hard to be sick and have people who don’t understand what you’re going through judge you,” said another supporter. “I hope you can find a pharmacy that will treat you with dignity and the compassion you deserve.”

“I know this oh too well trying to get my mom’s scripts filled when she was battling cancer running from store to store feeling and looking like a junkie. It was the most horrible part of it all!”  said another.

 “It’s astonishing the reaction it has gotten. I had no idea this was so common. It’s actually kind of sad how common it is,” Doyle told PNN. “It really struck a nerve with what’s apparently a big problem. I’m just dumbfounded by it.”

A Rite Aid spokesman said he could not comment on Doyle’s case.

“At Rite Aid, we are committed to providing high-quality care to all of our customers and patients. Rite Aid is not able to provide additional detail due to patient privacy,” Chris Savarese, Rite Aid Director of Public Relations said in an email.

Although the company has apologized to Doyle, she does not intend to go back to her neighborhood Rite Aid.

“I have decided to find a locally owned mom and pop pharmacy that really wants the business,” she said.

Is Fentanyl a Weapon of Mass Destruction?

By Lynn Webster, MD, PNN Columnist

Usually we think of bombs, missiles, rockets and dangerous chemicals as weapons of mass destruction (WMD). However, the military website Task & Purpose recently reported that James McDonnell, who heads the Department of Homeland Security’s WMD division, wants to classify fentanyl as a WMD.

McDonnell proposed this in a February memo to then-DHS Secretary Kirstjen Nielsen. The drug’s “high toxicity and increasing availability” make it “attractive to threat actors seeking nonconventional materials for a chemical weapons attack,” according to the memo.

There isn’t much evidence for classifying fentanyl as a WMD, but McDonnell’s suggestion could still find support for reasons that have more to do with politics than science.

According to federal law, weapons that can kill or severely injure "through the release, dissemination, or impact of toxic or poisonous chemicals, or their precursors" fall into the category of weapons of mass destruction.

McDonnell thinks fentanyl fits the definition. It is not clear that he is correct. And he neglected to mention that fentanyl has a legitimate medical use, too.

History of Fentanyl

Fentanyl is a powerful synthetic opioid typically prescribed to patients in acute pain or during surgeries. According to data from the National Center for Health Statistics, 48 million surgical inpatient procedures were performed in the United States in 2009. Most of those procedures involved administering fentanyl intravenously as an analgesic. 

Fentanyl was developed in 1960 by Belgian chemist Dr. Paul Janssen. The patent for fentanyl was obtained under his company name, Janssen Pharmaceutica. Fentanyl was first approved by the Food and Drug Administration in 1968 and introduced into the marketplace as an analog for Demerol, with plans that it would be used only for palliative care.

In 1978, I coauthored with my professor mentor, Dr. T.H. Stanley, a manuscript titled “Anesthetic Requirements and Cardiovascular Effects of Fentanyl” that described the use of high dose fentanyl for cardiac anesthesia.

The anesthetic technique we described allowed patients to undergo coronary artery bypass and valve replacement surgery more safely and with greater success because of fentanyl's unique pharmacologic properties. The technique was considered a seminal event in anesthesia for cardiac surgery.

Since the publication of that paper, millions of people have successfully undergone heart operations. The advance of using fentanyl in anesthesia may have helped some of those patients survive their heart operations.

It wasn’t until the late 1980s that testing was done for delivering fentanyl through a transdermal patch for the treatment of cancer-related pain and noncancer chronic pain. Later, oral transmucosal delivery of fentanyl was made available for cancer breakthrough pain. Each of these new uses of fentanyl exposed millions of Americans to the drug without evidence of an inordinate degree of harm if it was used as directed.

In contrast, nonpharmaceutical fentanyl has caused enormous harm. But as illicit use of the drug proliferates, so do myths about its dangers. McDonnell’s memo fits into an overarching narrative that bestows almost magical properties on fentanyl.

What's Behind the Fentanyl Panic?

The opioid crisis is real and the use of illicit fentanyl is often lethal. But mischaracterizing the effects of fentanyl may be only a political maneuver. 

In New York Magazine, Sarah Jones wrote about a 2017 Bloomberg News story that claimed fentanyl “is so potent that even a small amount — the equivalent of a few grains of salt — can be lethal.” 

“This isn’t really true,” wrote Jones. “You can’t get high or become ill simply by touching fentanyl, but police departments often claim otherwise. They report dramatic, but varied, symptoms that don’t mesh with established scientific evidence about fentanyl and the way it’s absorbed by the human body.” 

As Jones points out, Homeland Security’s WMD division has experienced a decline in funding because of the Trump administration’s focus on immigration and building a wall at the border. One way to reclaim some of that money for the WMD division is to build a case against fentanyl. 

Other drugs, such as ricin, pose greater risks and are probably more lethal than fentanyl as WMD’s. However, the word "fentanyl" packs a far larger emotional punch than ricin does because of the public's familiarity with it.  

WMDs are meant to kill the maximum number of people is the shortest amount of time. On the other hand, fentanyl -- even when it is laced with heroin -- is not intended to kill people. Drug cartels want to make money. Their goal isn't to murder their customers

Protecting Access to Legitimate Fentanyl 

The opioid crisis is now largely driven by nonpharmaceutical fentanyl and fentanyl analogs, not prescription fentanyl. Solving the opioid problem will require greater efforts to reduce the illegal production and distribution of illicit fentanyl. 

Could fentanyl be weaponized and used to attack citizens? Maybe, but not easily.  

The Pentagon realized the harm that an opioid attack could cause when the Russian military used aerosolized carfentanil -- a highly potent fentanyl analog --  against terrorists who had taken over a theater in Moscow in 2002. The drug killed dozens of innocent hostages and their captors, and it put the U.S. on notice that opioids could be weaponized.  

Before we classify fentanyl as a WMD, we need to know what that would mean for its legitimate use during surgery, or for cancer and chronic pain patients. Access to the medication for the treatment of pain must be part of the calculus in assessing if a relatively safe and effective drug should be classified as a WMD. 

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is a former president of the American Academy of Pain Medicine and the author of “The Painful Truth.”

You can find Lynn on Twitter: @LynnRWebsterMD. 

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.

What Next for CDC Opioid Guideline?

By Pat Anson, PNN Editor

The pain community is reacting with a fair amount of skepticism to efforts by the CDC to address the widespread misuse of its 2016 opioid prescribing guideline.

A CDC commentary published Wednesday in The New England Journal of Medicine warns against the “misapplication” of the guideline, which has resulted in hard dosing limits, forced tapering and the medical abandonment of thousands of chronic pain patients.

Although the guideline strongly recommends that daily doses of opioids not exceed 90 MME (morphine milligram equivalent), the guideline’s three co-authors say their advice was misinterpreted and that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages.”

A CDC media statement this week also claimed “the guideline does not support abrupt tapering or sudden discontinuation of opioids.” 

That was surprising news to Rob Hale, a Missouri man with late-stage Ankylosing Spondylitis, a degenerative and incurable form of arthritis.  Like many other pain patients, Hale’s relatively high dose of opioid medication was significantly reduced soon after the guideline’s release.  As a result, he is now bedridden.

“This is amazing news, if they really intend to follow through with it,” said Hale in an email. “God, I hope this is the beginning of a turnaround in prescribing policies.  I just feel for the hundreds of us who gave up and took their lives or died as a result of the last 3 years of cruelty.”

Saving Face

Why the CDC is acting now is unclear. Reports of patient harm began circulating soon after the guideline’s release in March 2016, and have only accelerated as insurers, pharmacies, states and practitioners adopted the guideline as mandatory policy. In a recent PNN survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide.

“I regard this CDC statement to be an effort to save face and maintain political dominance on an issue into which CDC improperly inserted itself under the influence of Andrew Kolodny and PROP,” said patient advocate Richard “Red” Lawhern, referring to the founder of the anti-opioid activist group Physicians for Responsible Opioid Prescribing.

“The statement fails to engage with the underlying issues which render the Guidelines fatally flawed.  It fails to acknowledge the essential repudiation of the entire guideline concept by the American Medical Association, plus multiple prominent medical professionals.” 

“The CDC guidelines have been as harmful as predicted, and the silence over 3 years has been criminal. The ‘Who me?’ response is just as evil as the ignorant abuse of power that led to the crisis in the first place,” said Mark Ibsen, MD, a Montana physician whose license was suspended by the state medical board for “overprescribing” opioids. A judge overturned the board’s ruling.  

“Those who give a weak ‘mea culpa’ for misinterpretation of the guidelines are, in short, lying. The deaths of thousands of abandoned pain patients, including 6 of mine who lost access (to opioids), are on their hands,” Ibsen said. 

PNN asked a CDC spokesperson if the agency had received new information about patients being harmed by the guideline and received a vague response.  

“We have heard concerns from partners and stakeholders about policies and practices that are inconsistent with the 2016 Guideline and sometimes go beyond its recommendations. The misapplication of the Guideline can risk patient health and safety,” Courtney Lenard said in an email. “CDC authored this commentary to outline examples of misapplication of the Guideline, and highlight advice from the Guideline that is sometimes overlooked but is critical to safe and effective implementation of the recommendations.” 

The response was also vague when we asked if CDC would be directly contacting insurers, pharmacies and states to warn them about misapplying the guideline.

“CDC has engaged payers, quality improvement organizations, state health departments, and federal partners to encourage implementation of recommendations consistent with the intent of the Guideline,” said Lenard, citing a mobile app and a pocket guide to opioid tapering as examples of CDC outreach.

The agency also sent out a Tweet.

Lenard gave no indication that a revision of the guideline was imminent. She said the CDC was working with the Association of Healthcare Research and Quality (AHRQ) to evaluate “new scientific evidence” about the benefits and harms of opioids.  

“Results of these reviews will help CDC decide whether evidence gaps have been addressed and whether the Guideline should be updated or expanded for chronic or acute pain prescribing,” Lenard wrote. 

.@CDCgov #OpioidGuideline does not support abrupt tapering or sudden discontinuation of #opioids. Learn more in our recent @NEJM commentary: https://t.co/vK0ESNyGTU pic.twitter.com/TXZ2jDdMJB

— CDC Injury Center (@CDCInjury) April 24, 2019

Undoing the Damage

The American Medical Association – which took a stand against the “inappropriate use” of the guideline last year -- released a statement saying the CDC needed to work more closely with insurers.

“The guidelines have been misapplied so widely that it will be a challenge to undo the damage. The AMA is urging a detailed regulatory review of formulary and benefit design by payers and PBMs (pharmacy benefit managers),” said AMA President-elect Patrice Harris, MD.

“The CDC’s clarification underscores that patients with acute or chronic pain can benefit from taking prescription opioid analgesics at doses that may be greater than the guidelines or thresholds put forward by federal agencies, state governments, health insurance companies, pharmacy chains, pharmacy benefit managers and other advisory or regulatory bodies.”

Dr. Ibsen said the Drug Enforcement Administration was “the other elephant in the room” because it has weaponized the CDC guideline to demonize and prosecute doctors for prescribing high opioid doses. 

“Arresting and punishing doctors who treat the sickest pain patients. Civil asset forfeiture as used in dealing with criminal drug dealers. Equate physicians with a license to practice as equal to or below said criminal drug dealers,” said Ibsen, listing some of the tactics used by prosecutors.

“Charge physicians with one felony for every Rx they write, making absurdly dramatic charging documents and headlines against doctors who are left with no income or assets to defend themselves in a contaminated jury pool. Charge doctors with murder for prescribing medications to patients who fail to follow the directions.”

It’s not just the DEA. The National Association of Attorneys General recently declared that the dose and duration of opioid prescriptions should not be decided by doctors and that the CDC guideline should essentially be treated as law.

“As a matter of public safety, there is simply no justification to move away from the CDC Guideline to encourage more liberal use of an ineffective treatment,” warns a letter signed by 39 state and territory attorney generals. “As Attorneys General of states with high rates of prescription drug abuse among our youth, policy makers and prescribers must be encouraged to continue to pursue laws and practices that reduce the high volume of opioids in our communities.”

“The standard of care is now determined by prosecutors and juries,” says Ibsen.

Pain Clinics Ordered Unnecessary Urine Drug Tests

By Fred Schulte, Kaiser Health News

A Tennessee-based chain of pain clinics that abruptly shut down last summer faces five whistleblower lawsuits accusing it of defrauding Medicare and other health insurers by billing for hundreds of unnecessary urine drug tests and other dubious health services, newly unsealed court records show.

The federal suits target Tennessee-based Comprehensive Pain Specialists, also known as Anesthesia Services Associates, PLLC, and several of its physician owners. At its peak, CPS ran 60 pain clinics in 12 states, according to the suits, as well as a lucrative urine-testing lab in Brentwood, Tenn. CPS closed with no warning in July, leaving patients in several states distressed and scrambling to find a new source of narcotic pain medicines.

In federal court filings unsealed in Nashville this week, federal prosecutors said they would take over the urine-testing allegations and sue several CPS owners, including co-founding anesthesiologists Peter Kroll and Steven Dickerson. Dickerson is a Republican state senator representing Nashville.

Kroll could not be reached for comment Wednesday. Dickerson did not respond to an email or a phone message left at his legislative office.

It is not clear whether the whistleblowers, who include former CPS doctors and other employees, would pursue several allegations against the company that the federal government declined to join in. CPS, in an unrelated court filing in December, said the company had terminated all of its employees and that debts “greatly exceed its assets.”

Once among the largest pain management groups in the Southeast, CPS crumbled amid financial woes that included nearly a dozen civil suits alleging unpaid debts, and a criminal investigation that ensnared its former chief executive, John Davis. Davis, 41, was convicted this month in federal court in Nashville on health care fraud charges. He is to be sentenced later this year.

CPS was the subject of a November 2017 investigation by Kaiser Health News that scrutinized its Medicare billings for urine drug tests. Medicare paid the company at least $11 million for urine screenings and related tests in 2014, when five of CPS’ medical professionals stood among the nation’s top such Medicare billers. One nurse practitioner working at a CPS clinic in Cleveland, Tenn., generated $1.1 million in urine-test billings that year, according to Medicare records analyzed by KHN.

Kroll, who also served as CPS’ medical director, said at the time that the tests were justified for patient safety and to reduce chances the pills might be sold on the black market. Kroll billed Medicare $1.8 million for urine tests in 2015, the KHN analysis of Medicare billing records found.

Kroll in an interview with KHN at the time said that he and fellow anesthesiologist Dickerson came up with the idea for the pain clinics over a cup of coffee at a Nashville Starbucks in 2005.

One of the whistleblower suits alleging unnecessary urine tests was first filed under seal in 2016 by Suzanne Alt, a doctor who worked in the company’s pain clinics in Troy, Mo., and Keokuk, Iowa, from May 2014 to March 2015. She alleged CPS doctors were “strongly encouraged to order full-panel urine drug screens on each patient, every time, despite the patient’s history, compliance and risk.”

She also said that the company’s electronic medical records “made it extremely difficult to order anything less than the full panel.” Alt said she was told the Tennessee lab did about 600 of these screens daily. Another whistleblower said he toured the lab with CPS executives and observed an “overpowering and unpleasant smell of urine.” In response, a CPS executive said, “To me, it smells like money,” according to the suit.

“They were making a killing,” said Birmingham, Ala., attorney Don McKenna, who represents Alt in the case.

Another of the whistleblowers, former CPS anesthesiologist Cynthia Niendorff, alleged that the company billed Medicare about $754 for each additional urine test, even though earlier results had come back negative. She said CPS grossed approximately $6 million per month from the urine-testing lab and said about 20% of this amount was suspect, according to the suit.

Mary Butner, a former insurance specialist for CPS in Gallatin, Tenn., alleged that CPS charged some patients $1,500 for a drug test to measure blood levels of medication and $400 for a drug test designed to detect illegal drugs — charges that the suit called “grossly inflated and disproportional to the actual costs.” She also alleged that CPS would fill prescriptions for patients whose drug tests detected the presence of illegal drugs, or showed that they were not taking their medication as directed.

Butner also accused medical director Kroll of approving prescriptions for back braces when it was “clearly medically unnecessary,” including some people who had injuries to a knee or elbow.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

CDC: Opioid Guideline Should Not Be Used to Taper Patients

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has taken its first concrete step to address the widespread misuse and misapplication of its opioid prescribing guideline.

In a commentary published in The New England Journal of Medicine, the guideline’s authors say the agency does not support abrupt tapering or discontinuation of opioid medication, and that the guideline’s recommendation that daily doses be limited to no more than 90 MME (morphine milligram equivalent) should only be applied to patients who are starting opioid therapy.

“Unfortunately, some policies and practices purportedly derived from the guideline have in fact been inconsistent with, and often go beyond, its recommendations,” wrote Deborah Dowell, MD, Tamara Haegerich, PhD, and Roger Chou, MD. “A consensus panel has highlighted these inconsistencies, which include inflexible application of recommended dosage and duration thresholds and policies that encourage hard limits and abrupt tapering of drug dosages, resulting in sudden opioid discontinuation or dismissal of patients from a physician’s practice.”

The co-authors also noted that the guideline “does not address or suggest discontinuation of opioids already prescribed at higher dosages,” nor does it seek to deny opioids to patients with cancer, sickle cell disease or recovering from surgical procedures.

The CDC’s clarification was cheered by patient advocates, who have been calling on the agency to address the suicides, patient abandonment and other unintended consequences of the guideline for over three years.

“The statement from the CDC is a long-awaited, robust clarification that has come at a critical time. They clearly defined that its Guideline cannot and should not be invoked to justify the forced reduction or denial of opioid pain medication to patients who use opioids to manage their long-term pain,” said Andrea Anderson, a patient advocate with the Alliance for the Treatment of Intractable Pain (ATIP).

The CDC’s controversial guideline was released in March 2016 as a voluntary set of recommendations meant to discourage primary care physicians from prescribing opioids for chronic non-cancer pain. But the guideline was quickly adopted by states, insurers, pharmacies, practitioners and even law enforcement agencies, who saw it as a mandatory policy that all physicians should follow to reduce rates of opioid addiction and overdose.

Reports soon began surfacing of patients being forcibly tapered off opioids or being abandoned by doctors who no longer wanted to treat them. Within months of the guideline’s release, CDC was warned by its own public relations consultants that “doctors are following these guidelines as strict law” and that some patients “are now left with little to no pain management.”

In PNN’s recent survey of nearly 6,000 patients, over 85 percent said the guideline has made their pain and quality of life worse. Nearly half say they have considered suicide because their pain is poorly treated. Many are hoarding opioids because they fear losing access to the drugs and some are turning to other substances – both legal and illegal – for pain relief.

‘Unintended Harms’

Not until this month did CDC acknowledge that its guideline was causing patient harm.

“CDC is working diligently to evaluate the impact of the Guideline and clarify its recommendations to help reduce unintended harms,” CDC Director Dr. Robert Redfield wrote in an April 10 letter to a group of healthcare professionals. who had asked the agency to make a “bold clarification” of the guideline.

Redfield’s letter was sent the day after the Food and Drug Administration warned doctors not to abruptly taper or discontinue opioids. The FDA said it had received reports of “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.    

“The clarification is an essential beginning because it is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia,” said Kate Nicholoson, a civil rights attorney and pain patient.  

“It is the CDC guideline that has been used by law enforcement agencies to surveil doctors and by major insurers and pharmacies in ways that deny pain patients access to opioid analgesia.”

— Kate Nicholson, Civil Rights Attorney

“Given the harms suffered by pain patients, a muscular, public-facing clarification from the CDC was needed. We hope that this action and the warning the FDA issued last week against abrupt tapering of pain patients will mark a beginning in protecting the rights of patients who use opioid medication appropriately to manage pain.” 

But other patient advocates wonder why it took so long for the CDC to act.

“It's gratifying to see CDC admit that its guideline is being misinterpreted and misapplied, as many of us have been warning for some time,” said Bob Twillman, PhD, former Executive Director of the Association of Integrative Pain Management. “It's a bit puzzling to me why it has taken them three years to do so, when many of us, myself included, told them within days of the guideline's issuance that these things were going to happen.

“Unfortunately, we've spent the past three years watching three dozen states violate CDC's stated intent that the guideline not be legislated, not to mention the untold numbers of insurance companies, health care systems, private practices, and pharmacy chains that have created a whole population of opioid refugees by misusing the guideline. Serious harms, including patient deaths, have resulted, and there is virtually no evidence that the intended effect of reducing prescription opioid overdose deaths has occurred, while overall opioid overdose deaths continue to climb rapidly.”

The New England Journal of Medicine is a respected publication with a wide reach among healthcare professionals, but it is not clear what CDC will do to caution states, insurers, pharmacies and law enforcement agencies about their misuse of the guideline.

“Unless Congress and the Executive Branch tell the DEA (and by association, state drug enforcement authorities and prosecutors) to stand down from persecuting doctors, I don't see any useful impact for this statement at all,” Richard “Red” Lawhern, PhD, of ATIP wrote in an email. “Doctors will continue to leave pain management and to desert their patients until they can be assured they will not be sanctioned, so long as they act in good faith to treat pain and manage their patients.” 

In recent months, federal prosecutors in Wisconsin and several other states sent letters to hundreds of physicians warning them that their opioid prescribing practices exceed those recommended by the CDC. The doctors were identified through data-mining of prescription drug monitoring programs (PDMPs), which have been weaponized to target physicians. 

“Practitioners were identified where they prescribed on average 90 MMEs (or more) per patient per day. That’s the threshold where the CDC and the Wisconsin Medical Examining Board say there is no real evidence to suggest that above that amount has any better effect on chronic pain,” a DOJ spokesperson told PNN.  

Just last week, a DEA task force charged dozens of doctors and other healthcare providers with illegal opioid prescribing. Prosecutors say more criminal cases are in the pipeline. 

"We have hyper-accurate data at the DEA and other agencies in the federal government where we are able to (use) that data and we can sort of pinpoint where these pills are being over-prescribed just by the population center in which they're being prescribed," said Jay Town, a federal prosecutor in Alabama.  "There are more doctors out there, there are more people working in clinics, and physicians’ offices, or pharmacies, or in compounding pharmacies, that we still have ongoing investigations or beginning investigations.” 

‘Achieve Widespread Adoption’ 

The CDC may have finally acknowledged the “unintended harms” caused by the guideline, but the data-mining and wholesale adoption of its recommendations are exactly what the agency outlined in a 2015 CDC memo obtained by PNN:   

“Efforts are required to disseminate the guideline and achieve widespread adoption and implementation of the recommendations in clinical settings. CDC is dedicated to translating this guideline into user-friendly materials for distribution and use by health systems, medical professional societies, insurers, public health departments, health information technology developers, and providers, and engaging in dissemination efforts.  

Activities such as development of clinical decision support in electronic health records to assist providers’ treatment decisions at the point of care, identification of mechanisms that insurers and pharmacy benefit plan managers can use to promote safer prescribing within plans, and development of clinical quality improvement measures and initiatives to improve prescribing and patient care.”

Can the CDC undo all the harm its “user-friendly materials” have caused over the last three years? Will states be advised to rollback their laws and regulations? Will insurers and pharmacies be told to stop limiting the dose of opioid prescriptions? And what about the patients who committed suicide? The CDC did not respond to a request for comment.

“That no one at CDC anticipated that the guideline would be misinterpreted and misapplied in this way is hard to swallow,” said Twillman. “I would have hoped that they would be vigilant for such occurrences, and taken action swiftly and effectively when they became apparent.”

What It’s Like to Be Forcibly Tapered Off Fentanyl

By Emily Ullrich, Guest Columnist

Although I have been on this chronic intractable pain, illness and medical refugee train for nearly a decade, I’ve been lucky to have the love and support my husband, family and wonderful people around the world that I've met through this shared anguish. They lift me up and allow me to lift them, when I can.

Right now, I'm holding onto them in utter panic, because they’re all that I have left.

About four years ago, I met a palliative care doctor, who had taken the time to read my 3-page health history. I take that paperwork with me to every visit to the ER or new doctor, so they can fully understand the things that I have tried, what worked, and what made things worse. No doctor had ever looked at it, until she did.

She approached me with zero judgment, and 100% sympathy and empathy. She actually cared about what I'd been through. I broke down sobbing, because I could finally let my guard down. I told her how my husband had to take a day off from work every month to drive me five hours and three states away, to see the only doctor I could find who was willing to treat my complicated needs. She told me I could see her instead. That was a tremendous gift.

Last year I began to sense that there was growing pressure on her about prescribing high doses of opioids, so I asked if I should worry about her cutting my meds or passing me off to another doctor. She reassured me that she would do no such thing.

Then came my visit one month later. I knew something was awry, because there was a case worker present for my appointment. My suspicions were confirmed when I was told the dose of my fentanyl patch would be tapered significantly lower. I was thrown into a tailspin.

With my doctor’s help and willingness to prescribe the meds and dosages that I needed, I had been able to achieve about a 4/10 on the pain scale, daily. I was able to participate in life again and do things that I love, like cooking, getting dressed up to go on a date with my husband, and other things that healthy people take for granted.

I was furious and traumatized that I was going to have to give up living my life. I still am.

On my next visit to see my doctor, she dropped another bomb. She told me that I had to choose between anti-anxiety meds and pain meds. Ironically, she was the one who put me on a higher dose of Xanax to help me cope with anxiety and insomnia. I felt betrayed.

I would not wish the hell of abruptly and simultaneously tapering off fentanyl and Xanax on anyone.  Even when I had a higher dosage, I still had pain flares that were not properly controlled. But since the taper began, I now have them daily.

I want this to be very clear: Fentanyl is a necessary medicine for many people with high pain levels. I have tried every other extended release medication known and none even touched my pain.

Fentanyl has gotten a bad reputation and patients who take it live with heavy stigma because the media usually report on fentanyl overdoses without distinguishing between illicit fentanyl and properly prescribed legal fentanyl.  

I would like to make a plea to the media: Stop the ignorant reporting and do your due diligence. By not distinguishing between legal and illicit fentanyl, you are causing even more strife for those of us who need the relief that only fentanyl medication brings.

I have still not gotten a clear reason for my doctor's decision to force a taper on me. I fear if I prod too much, she will totally cut me off or advise me to see someone else. This is making the struggle even worse, because even though we still have a pleasant relationship, I'm hurt and confused about this. I suspect it is being forced upon her.

As I wrote this, I had to take breaks for hours, sometimes days, because my pain is escalating to such a level that anxiety and insomnia are ravaging my mind and body. I have been in withdrawal (which, by the way, does not mean I am addicted to my medication, it means I'm physically dependent on it) for about four months.

As my medicine has been tapered, my life has crumbled. I get about two hours of sleep every five days. At times I get uncontrollable head shaking, leg kicking, arm flailing and vocal ticks. My pain gets so bad that I develop a full-body rash and migraines that last for days.

I don't know what is real and what my brain has concocted. I hold nonsensical conversations, like my grandparents did when they developed dementia. It is embarrassing and terrifying.

One night, while counting down the minutes until I could take my next dose of meds, I passed out from pain and anxiety, which scared my husband so bad that he called 911.

I hope that insurers, pharmacies and especially government officials who are infringing on doctors' ability to treat their patients, might read this and see that forcing tapers on patients is dangerous. There have already been many suicides because of them.

A gap is growing between many doctors and their patients. We know this is not “What's best for us.” It is actually a twisted way to make more money off the sick and vulnerable, forcing us to replace a medicine that is effective and safe when used responsibly with drugs that are ineffective, expensive and dangerous.

Emily Ullrich lives with Complex Regional Pain Syndrome (CRPS), chronic pancreatitis, endometriosis,  interstitial cystitis, migraines, fibromyalgia, osteoarthritis, anxiety, insomnia, depression, and other chronic illnesses. She is also a writer, filmmaker, activist, advocate, philanthropist and comic. As she is able, Emily devotes her time and energy fighting for pain patients’ rights.

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.