U.S. Life Expectancy Still Declining

By Pat Anson, PNN Editor

After decades of progress with Americans living longer and healthier lives, a disturbing new study has documented how life expectancy in the U.S. has declined for three consecutive years.

The drop in life expectancy was most pronounced in young and middle-aged adults. Starting in 2014, midlife mortality increased across all racial groups, largely due to drug overdoses, alcohol abuse, suicide, and chronic illnesses such as hypertension and diabetes. Researchers said prescription opioids were more of a symptom than a cause of premature deaths.

In 2014, Americans were expected to live to 78.9 years of age. By 2017, the average life expectancy had fallen to 78.6 years.

The U.S. now has the worst midlife mortality rate among 17 high income countries, even though it spends more on healthcare per capita than any other nation.  

“This is an emergent crisis. And it is a uniquely American problem since it is not seen in other countries. Something about life in America is responsible,” lead author Steven Woolf, MD, reported in a Special Communication published in JAMA.

The largest increases in midlife mortality occurred among adults with less education and those living in rural areas.  Changes in life expectancy were greatest in upper New England, the Ohio Valley, and Appalachia – regions where economic distress, lower social mobility and the so-called epidemic of despair contributed to rising rates of suicide and drug and alcohol abuse.

“While it’s a little difficult to place the blame on despair directly, the living conditions causing despair are leading to other problems,” said Woolf, who is director emeritus of the Center on Society and Health at Virginia Commonwealth University. “For example if you live in an economically distressed community where income is flat and it’s hard to find jobs, that can lead to chronic stress, which is harmful to health.”

While life expectancy increased in a handful of Western states, midlife mortality rose in Ohio and West Virginia – states often called ground-zero of the opioid crisis.  A sharp increase in opioid overdoses came in three waves; starting with the introduction of OxyContin and the overuse of prescription opioids in the 1990s, followed by increased heroin use, and then the emergence of illicit fentanyl – which triggered another wave of opioid overdoses starting in 2013.

“However, the increase in opioid-related deaths is only part of a more complicated phenomenon and does not fully explain the increase in midlife mortality rates from other causes, such as alcoholic liver disease or suicides. Opioid-related deaths also cannot fully explain the U.S. health disadvantage, which began earlier (in the 1980s) and involved multiple diseases and nondrug injuries,” Woolf said.

The tsunami of fentanyl overdoses has yet to dissipate. According to a new study by the Massachusetts Department of Public Health, 93% of opioid related overdoses in the state in the first nine months of 2019 involved fentanyl. Deaths involving prescription opioids such as oxycodone and hydrocodone peaked in 2014 and are now linked to only about 10% of overdose deaths in Massachusetts.

FDA Approval Gives New Hope to Patients With Rare Genetic Disease

By Pat Anson, PNN Editor

Lisa Kehrberg was once frightened about her future. For years the retired family practice doctor and mother of two would suffer severe bouts of unexplained abdominal pain, headaches and nausea that would leave her hospitalized for weeks at a time.

“I was doubled over, rocking, vomiting and crying with the worst pain of my life. Worse than labor, appendicitis, or anything else I'd experienced. It was a hot, burning pressure that was like lava and hot razor blades filling up my abdomen,” Lisa recalled.

She was eventually diagnosed with a rare genetic disease called acute intermittent porphyria, which causes toxic molecules to build up in the body. The same disease killed Lisa’s brother in 2011. And she thought the same fate awaited her.

“One of the most common causes of death from porphyria is suicide. This isn't surprising. I always wonder how people who are sick like me keep surviving. To live in continuous excruciating pain every minute of every day with no end in sight is quite the challenge,” Lisa wrote in a 2016 column for PNN.

It was about that time that Lisa entered a clinical trial program. Every four weeks she’d travel to Houston from her home near Chicago for injections of an experimental drug. Over time, her symptoms began to improve and the porphyria attacks that used to occur monthly became less frequent.

LISA KEHRBERG, MD

Like other participants in clinical studies, Lisa wasn’t allowed to talk publicly about the drug she was getting – until now.  

The Food and Drug Administration has just approved the use of Givlaari (givosiran) for the treatment of adult patients with acute hepatic porphyria (AHP). Approval was granted based on results from placebo controlled trials involving 94 porphyria patients. Those who received Givlaari experienced 70% fewer porphyria attacks compared to patients receiving a placebo.  

“Prior to getting givosiran I was bed-bound for close to 6 months straight from severe muscle weakness and paralysis issues. I no longer have paralysis and most of the muscle weakness has resolved,” Lisa said in an email. “The rate of new attacks has decreased greatly, finally giving my nerves a chance to heal after 22 years of attacks and 6 years of back-to-back attacks.”

“These attacks occur suddenly and can produce permanent neurological damage and death,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in a statement Wednesday. “Prior to today’s approval, treatment options have only provided partial relief from the intense unremitting pain that characterizes these attacks. The drug approved today can treat this disease by helping to reduce the number of attacks that disrupt the lives of patients.”

The FDA approved Givlaari under its breakthrough therapy, priority review and orphan drug designations, which provide incentives to companies in the development of drugs for rare diseases. Approval was granted to Alnylam Pharmaceuticals, which expects Givlaari to be available to healthcare providers by the end of the year.

There are about 3,000 people diagnosed with active porphyria in the U.S. and Europe. Due the wide array of symptoms the disease has, it can take years before an accurate diagnosis is made.

“The FDA approval of Givlaari is an important milestone for our community, as we now have a new treatment option for adults living with acute hepatic porphyria,” said Kristen Wheeden, Executive Director of the American Porphyria Foundation.

Image courtesy of Alnylam Pharmaceuticals

“AHP can have a profound impact on the lives of patients and their families. Porphyria attacks are associated with severe, incapacitating pain, often requiring hospitalization for management. In addition, many patients struggle on a daily basis with chronic symptoms related to their disease. The approval of Givlaari is exciting for our community.”

Lisa Kehrberg isn’t out of the woods just yet. She has permanent nerve damage from years of porphyria attacks. But her future is a lot brighter than it was.  

“For newly diagnosed patients, I strongly believe this treatment has the ability to stop the progression of the disease and will allow patients to lead a normal, functional life,” she says. 

Little Evidence to Support Rescheduling of Tramadol

By Roger Chriss, PNN Columnist

The consumer watchdog group Public Citizen has petitioned the FDA and DEA to “upschedule” the opioid painkiller tramadol. The DEA set tramadol as a Schedule IV drug in 2014, and the petition urges moving it to a more restrictive Schedule II, on the same risk level as hydrocodone and oxycodone.

The petition claims that tramadol is “an increasingly overprescribed, addictive, potentially deadly narcotic.” But the basis for this claim and the assumption that upscheduling will help are problematic.

The CDC reports that there were approximately 1,250 fatal overdoses involving tramadol in 2017, the most recent year for which data is available. Like most fatal overdoses, tramadol deaths often involve multiple drugs, so it’s hard to draw any conclusions from those deaths.

Tramadol is complex, with a highly variable patient response. Some patients have such a strong negative reaction to the drug that they refuse to take it again. Others find it too sedating at high doses or too weak to provide adequate pain relief. Abuse, addiction and overdose can also occur with tramadol.

Recently Harvard Health looked at a JAMA study on the risks of using tramadol versus other pain relievers. Tramadol was found to have a higher risk of death than anti-inflammatory medications such as naproxen (Aleve), while people treated with codeine had a similar level of risk.

“However, because of the study’s design, the researchers could not determine whether tramadol treatment actually caused the higher rates of death. In fact, the patients for whom tramadol is prescribed could make it look riskier than it truly is,” said Robert Shmerling, MD, an editor at Harvard Health.

Unintended Effects of Upscheduling

Understanding the effects of upscheduling is tricky. In 2014 the DEA reclassified hydrocodone (Vicodin) from Schedule III to the more restrictive Schedule II. The reclassification accelerated a trend that was already underway – hydrocodone prescriptions had been falling since 2011.

But there were unintended consequences to upscheduling. A recent University of Texas study found that decreases in hydrocodone prescribing after its rescheduling “were larger in patients being treated for cancer.”

Anotherr study found that upscheduling led to a substantial decrease in hydrocodone prescribing in hospital emergency departments, but that was offset by an increase in prescriptions for codeine and anti-inflammatory drugs.

Upscheduling hydrocodone has also had a negligible effect on overdoses, which are largely caused by illicit fentanyl, heroin and other street drugs, as well as non-opioid medications such as Xanax.

Similarly, predicting the impact of new prescription opioids is difficult. Breathless warnings about the opioid Zohydro, which was approved as a Schedule II drug in 2014, proved false. “There was no great surge of overdoses” after Zohydro was introduced, as Chris MacGreal wrote in his book “American Overdose.”

Fears about opioids are also delaying the introduction of safer medications. The experimental opioid NKTR-181 has less abuse potential than traditional opioids, but its approval is uncertain because the FDA has stopped all advisory committee meetings on opioid analgesics.

Public Citizen ignores all this. It also fails to mention other actions the FDA could pursue, from making naloxone into an over-the-counter drug to improving access to medication-assisted therapy for opioid use disorder. There’s no petition to have the DEA “nix the wavier” for buprenorphine (Suboxone) to make it more widely available or to have the federal government promote the Pain Management Best Practices Inter-Agency Task Force report.

Finally, there’s no call to monitor outcomes. As PNN has reported, opioid tapering has had tragic unintended consequences. And a new Cochrane review on the effects of educational and regulatory efforts targeting prescribers was unable to draw any conclusions “because the evidence is of very low certainty.” The authors could find only two relevant studies that assessed prescribing policies adopted in the 1990’s.

There are good reasons to be cautious about tramadol. But there are probably better ways than upscheduling to reduce risks and improve outcomes. As a result, Public Citizen's petition seems quite narrow and unlikely to help with the overdose crisis.

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.

This column 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.

Experts Warn Rx Opioids Being Denied to Breast Cancer Patients

By Pat Anson, PNN Editor

Patients with advanced breast cancer are being denied opioid pain medication due to lack of supply in poor countries and a backlash against opioid addiction in the United States, according to experts at an international conference on breast cancer recently held in Lisbon.

In a session agreeing to new guidelines for treating breast cancer, oncology experts at the Advanced Breast Cancer Fifth International Consensus Conference also called for better access to a group of anti-cancer drugs called CDK4/6 inhibitors. The drugs help breast cancer patients live longer and improve their quality of life, but are often not available.  

The guidelines also warn that cancer patients should not have limits placed on their access to adequate pain control.

“Patients with advanced breast cancer can suffer pain and other symptoms, particularly towards the end of their lives. We need to ensure that appropriate pain medications and other symptom interventions are available to them,” said conference co-chair Eric Winer, MD, Director of Breast Cancer Program at Dana-Farber/Harvard Cancer Center in Boston.

“We acknowledge that the misuse of opioids is a big problem, particularly in the United States, but we need to make sure that in trying to deal with this problem we do not interfere with pain management in cancer patients. In addition, in some low- and middle-income countries, such as some in Africa, there are problems with patients being able to access any form of pain relief, and this needs to be addressed urgently.”

The panel of experts also called for more research into the use of cannabis for managing pain and other symptoms in patients with advanced breast cancer. But they cautioned that cannabis should not replace pain relievers that have been proven to work.

“The panel encourages research on the potential role of cannabis to assist in pain and symptom control but strongly stresses that it cannot replace proven medicines, such as morphine, for adequate pain control,” the guideline state.

Over two million new cases of breast cancer are diagnosed worldwide ever year, and there are about 600,000 deaths annually from the disease.

Confusion Over CDC Guideline

Although the CDC’s 2016 opioid guideline is only intended for primary care physicians treating non-cancer pain, the recommendations include patients “who have completed cancer treatment, are in clinical remission, and are under cancer surveillance only.”  

Experts say the CDC’s inclusion of cancer survivors is a mistake because it is not uncommon for cancer pain to persist long after the cancer is treated.  The CDC’s recommendations also conflict with cancer treatment guidelines that suggest doctors use both short and long-acting opioids when treating flares from cancer pain. The CDC recommends against long-acting opioids because of the potential risk of addiction.

The conflicting recommendations have caused confusion for oncologists and pharmacists, and agony for cancer patients not getting proper pain relief.

Earlier this year, a Rite Aid pharmacist refused to fill an opioid prescription for a California woman with Stage 4 terminal breast cancer.  April Doyle posted a tearful video online about her experience at the pharmacy that went viral. The pharmacist and a Rite Aid manager later apologized to Doyle for the incident.  

Rx Drug Databases Linked to Heroin Deaths

By Pat Anson, PNN Editor

Prescription drug monitoring programs (PDMPs) in the U.S. are often promoted as critical tools in preventing opioid abuse and addiction. But a new study suggests that some PDMPs may be having the unintended effect of driving pain patients to street drugs such as heroin.

PDMPs in 49 states (the one exception is Missouri) allow physicians and pharmacists to consult a drug database to see if patients are “doctor shopping” or getting too many opioid prescriptions. The databases are also used by law enforcement agencies to identify doctors who prescribe high levels of opioid medication.  

A team of researchers reported in the International Journal of Drug Policy that there was a “consistent, positive, and significant association” between the adoption of PDMPs and fatal heroin overdoses. By the third year of a state adopting a PDMP, there was a 22% overall increase in heroin fatalities.

The increase was not uniform across all PDMPs.  States with “Proactive” PDMPs, which are more likely to flag suspicious activity by doctors and patients and report them to law enforcement, had a slight decline in heroin overdoses, while states with weaker PDMPs had significant increases in heroin deaths.

“The study just shows that heroin is an alternative to prescription pain medicine,” says John Lilly, DO, a Missouri physician who opposes PDMPs. “The harder it is to get prescription pain medicine, the more heroin deaths and presumably heroin use occurs. Market forces at work. Heroin is not the big alternative. It’s illicit fentanyl.”

It's not the first time researchers have found mixed results on the effectiveness of PDMPs. A 2018 study also found an increase in heroin deaths associated with PDMPs, along with a decline in overdoses linked to prescription opioids.

"It's pretty striking that this is the second study where we have found that PDMPs with robust features such as sending unsolicited alerts about outlying prescribing and dispensing patterns to PDMP users, and providing more open access to PDMP data, are associated with a small decline in opioid overdose deaths," said senior author Magdalena Cerdá, DrPH, an associate professor and director of the Center for Opioid Epidemiology and Policy at NYU Langone Health.

"In our prior study we found that these types of PDMPs were associated with a decline in prescription opioid overdose deaths, and this new study suggests Proactive PDMPs may also have a downstream protective effect on heroin overdose risk."

Cerdá and her colleagues believe PDMPs that aggressively flag and report suspicious activity will help stop inappropriate prescribing sooner and better identify patients in need of addiction treatment, preventing their transition to heroin. 

“To the best of our knowledge, this study is the first to identify specific classes of PDMP characteristics that are most strongly associated with changes in rates of fatal heroin poisonings,” said lead author Silvia Martins, MD, an associate professor of epidemiology at Columbia Mailman School of Public Health. “We believe those authorized to access the data should be trained to protect individual privacy and confidentiality and ensure that it is used only to improve care for the patient.”

DEA Sues Colorado for Access to PDMP

Patient privacy is at issue in an unusual lawsuit filed last week by the Drug Enforcement Administration against Colorado’s Board of Pharmacy. The DEA subpoenaed the board to release patient data from Colorado’s PDMP to assist in the investigation of two pharmacies. But the state refused to comply, citing privacy concerns.

“The Department of Regulatory Agencies is committed to combating the opioid epidemic that remains a devastating issue for many Colorado communities,” spokeswoman Jillian Sarmo said in an email to the Colorado Sun. “We continue to work with our partners in other agencies in this fight, but we have an obligation to do so in a targeted and thoughtful manner that ensures the privacy of the hundreds of thousands of individual patients in the state whose personal prescription records have no connection to any criminal activity and whose disclosure has no relevance to any criminal investigation.”

Also named in the DEA lawsuit is Appriss, Inc., a private company that Colorado and dozens of other states use to collect and maintain their PDMP data. If a federal judge rules in favor of the DEA in Colorado, it could set a legal precedent that would force Appriss to release prescription data from other states.

“We are taking this action as part of our office’s efforts to aggressively pursue law enforcement investigations of anyone who may be breaking the law,” U.S. Attorney Jason Dunn said in a statement.  “We are disappointed with the refusal to comply with these lawful subpoenas, a refusal that has forced us to seek aid from the court in getting the information we need to carry out important law enforcement investigations aimed at combating the prescription drug abuse epidemic.” 

A recent study undermines much of the association between overdoses and prescription opioids that are obtained legally. Researchers say only 1.3% of overdose victims in Massachusetts had an active prescription for the opioid that killed them — meaning PDMPs would have little value in preventing the other 98.7% of deaths.

Patients on Rx Opioids Often Tapered at Risky Levels

By Pat Anson, PNN Editor

Tens of thousands of pain patients on long term opioid therapy have been cutoff or tapered to lower doses more rapidly than recommended, putting them at risk of withdrawal, uncontrolled pain and suicide, according to a large new study.

The study, published in JAMA Network Open, is one of the first to assess the impact of the 2016 CDC opioid guideline and other measures aimed at reducing opioid prescribing.

Researchers at University of California Davis reviewed the prescription records of over 100,000 patients on stable opioid doses from 2008 to 2017.

The percentage of patients who were tapered rose significantly during the study period -- from 10.5% in 2008 to 22.4% in 2017 – especially for patients on relatively high daily doses that exceeded 90 MME (morphine milligram equivalent).

“Opioid tapering has become increasingly common among patients using long-term opioids, particularly among patients taking higher doses and since the publication of the CDC opioid prescribing guideline,” researchers found.   

SOURCE: JAMA NETWORK OPEN

“Our results also suggest that many patients undergo tapering at rapid maximum rates. The downstream effects of opioid tapering on pain, withdrawal, mental health, and overdose risk warrant careful evaluation.”

Federal guidelines recommend a gradual dose reduction of about 10% per month. But researchers found that tapering for nearly one in five patients exceeded that level and some were tapered at rates six times higher than recommended. The average dose reduction overall was 27.6% per month.

"Tapering plans should be based on the needs and histories of each patient and adjusted as needed to avoid adverse outcomes," said study author Alicia Agnoli, MD, an assistant professor of family and community medicine at UC Davis. “Unfortunately, a lot of tapering occurs due to policy pressures and a rush to get doses below a specific and sometimes arbitrary threshold. That approach can be detrimental in the long run."

Too rapid tapering can have devastating consequences on patients and their families. Such was the case for Bryan Spece, a 54-year old Montana man who committed suicide after his dose of oxycodone was abruptly reduced by 70 percent. The pain clinic that tapered Spece said it was following the CDC guideline.

"He was the last person anyone would have thought to take his own life. He was just not that guy," a family member told PNN. "I know he was in a lot of pain and in a very dark spot."

Women More Likely to Be Tapered

Although men are twice as likely as women to die from an opioid overdose, UC Davis researchers found that tapering rates for women were about 13% higher than men, which they attribute to a possible sex bias.

“When considering dose tapering for patients, clinicians may fear that a recommendation of tapering may prompt angry or even violent responses, particularly from male patients. Such perceptions may be associated with a sex bias among clinicians, manifesting as a greater willingness to initiate tapering among women than men,” researchers said.

Although patients who survive an opioid overdose are at substantial risk of overdosing again, the study found that less than one in four patients (23.4%) with recent overdoses were tapered by their prescribers.

Researchers hope to build on the study further to develop best practices for dose reduction.

"Ultimately, we want to clarify the effects of tapering on patients and how to help them taper to maximize benefits and minimize risks," said lead author Joshua Fenton, MD, a professor of family and community medicine at UC Davis. "We expect this line of research will have important implications for how physicians manage and monitor patients who are undergoing opioid tapering."

The Food and Drug Administration first warned in April that many pain patients were being tapered inappropriately, putting them at risk of serious harm. That was followed a few days later by a pledge from CDC Director Robert Redfield, MD, to evaluate the impact of the agency’s opioid guideline and to “clarify its recommendations.”

Seven months later, not a single word of the CDC guideline has been changed or clarified. Outside of an editorial published in the New England Journal of Medicine, the CDC has made no effort to publicize or widely disseminate warnings to doctors not to taper patients too rapidly.

Not until last month – three and a half years after the CDC guideline was released – did the Department of Health and Human Services publish a 6-page guide for doctors on how to taper patients. The guide encourages prescribers to collaborate with patients and “obtain patient buy-in” before starting a tapering program.

Petition Urges DEA to Reschedule Tramadol

By Pat Anson, PNN Editor

In 2014, the U.S. Drug Enforcement Administration reclassified the opioid hydrocodone as a Schedule II controlled substance, citing evidence that the painkiller has a high potential for abuse and addiction. The change made it harder to obtain the drug and led to a sharp decline in hydrocodone prescriptions.

That same year, the opioid tramadol was classified for the first time as a Schedule IV drug – a less restrictive category that means it has low potential for abuse and addiction. Prescriptions for tramadol surged.

Five years later, a consumer watchdog group is saying that was a mistake. Public Citizen has filed a petition with the FDA and DEA asking that tramadol be reclassified as a Schedule II drug, on the same risk level as hydrocodone, oxycodone, morphine and fentanyl. The petition claims there is “overwhelming evidence” that tramadol is a public health risk, particularly for people who rapidly metabolize the drug.

“New evidence has accumulated showing that tramadol is an increasingly overprescribed, addictive, potentially deadly narcotic that should be rescheduled to Schedule II,” the petition states. “Tramadol’s current placement in Schedule IV has generated a false perception of the drug’s safety profile — particularly with respect to its potential for abuse, dependence, and addiction — among both prescribers and patients, which has contributed to the large increase in its prescribing following the DEA’s 2014 rescheduling of hydrocodone.”

Tramadol is considered a “weak” opioid because it does not bind directly to opioid receptors in the brain like hydrocodone and other opioids do. Many patients say tramadol gives them little or no pain relief, but it’s often the only opioid their doctor is willing to prescribe.

Tramadol is the active ingredient in several brand name painkillers such as Ultram, Ultracet, Ryzolt and Rybix. About 32 million prescriptions for tramadol were filled last year in the U.S.

“The failure to designate tramadol as a controlled substance when it was initially approved by the FDA and the subsequent placement of the drug in a less restrictive category has promoted the false belief that the drug must have a much better safety profile than other opioids,” Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in a statement.

“The dangerous misperception of tramadol’s safety has led to reckless overprescribing of the drug during the past several years of the opioid epidemic.”

According to government health surveys, tramadol was misused by about 1.5 million people in 2018 – exceeding the number of people that misused morphine and some other Schedule II opioids.

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.

A recent study by the Mayo Clinic found that patients given tramadol after surgery have a slightly higher risk of prolonged use than those receiving oxycodone or other short acting opioids.

Tramadol was classified as a Schedule 3 drug in the United Kingdom in 2014. It is still an unscheduled drug in Canada, although Health Canada has proposed classifying it as a Schedule I controlled drug.

Tramadol is widely abused in West, Central and North Africa.

CDC Guideline Author Leading New Rx Opioid Study

By Pat Anson, PNN Editor

One of the co-authors of the CDC’s controversial 2016 opioid guideline is leading a new federal study about the effectiveness of opioid medication in treating chronic pain, Pain News Network has learned. 

Dr. Roger Chou is a primary care physician who heads the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University (OHSU), which was awarded a $500,000 contract to conduct the opioid study by the federal Agency for Healthcare Research and Quality (AHRQ).   

A draft version of the AHRQ report echoes many of the conclusions drawn by the CDC – that there is little evidence to support the use of opioids for chronic pain and that nonopioid pain relievers such as Tylenol are just as effective as Vicodin.

Even when used for short-term acute pain, the draft report found “no differences between opioids versus nonopioid medications in improvement in pain function, mental health status, sleep, or depression.”

The AHRQ has not publicly disclosed the authors of the draft report, and only acknowledged in a statement to PNN that “the OHSU team is comprised of several experts who draw upon diverse experience and expertise in pain management.” Their final report is expected in January 2020.

In addition to his work on the CDC guideline, Chou has authored numerous articles on pain management in peer-reviewed medical journals and has led research efforts for the U.S. Preventive Services Task Force, World Health Organization and the American Pain Society. But Chou’s involvement in the AHRQ study has caused some alarm among patient advocates, who believe he and the agency are biased against prescription opioids.

“The agency is operating under a political agenda that has little to do with medical evidence or truth,” said Richard “Red” Lawhern, PhD, a patient advocate with the Alliance for the Treatment of Intractable Pain. “The report is fatally flawed and must be immediately withdrawn without replacement. AHRQ owes the public and millions of people in pain a public apology for its malfeasance and misdirection.”

PROP Collaboration

Most health researchers keep a low profile and try to avoid controversy, but Chou has publicly collaborated with Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group that seeks drastic reductions in the use of opioid medication.

Chou recently co-authored an article with PROP President Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to consider tapering “every patient receiving long term opioid therapy.”

Chou and his co-authors thanked PROP Executive Director Dr. Andrew Kolodny and other PROP board members for their help in drafting the article:

“Acknowledgment: The authors thank the Oregon Pain Guidance Working Group (Jane Ballantyne, Roger Chou, Paul Coelho, Ruben Halperin, Andrew Kolodny, Anna Lembke, Jim Shames, Mark Stephens, and David Tauben) for discussions about tapering and for reviewing a draft of this article.”

As PNN has reported, Kolodny, Ballantyne and Lembke have worked as paid consultants to law firms that stand to make billions of dollars from opioid litigation. Their legal work was only recently disclosed in revised conflict of interest statements.

It is not clear if PROP members are involved in the AHRQ study, as they were with the CDC guideline. As a matter of policy, AHRQ does not disclose the names of its consultants and investigators until after reports are completed.

“This policy is aimed at helping the authors maintain their independence by not being subject to lobbying by industry reps or others with conflicts of interest, either financial or intellectual,” AHRQ spokesman Bruce Seeman said in an email.

“AHRQ’s failure to disclose Chou as an author of its draft report is troubling, given his prior work with Ballantyne and Lembke, who have admittedly worked on behalf of PROP in the past.”

— Dr. Chad Kollas

“AHRQ’s failure to disclose Chou as an author of its draft report is troubling, given his prior work with Ballantyne and Lembke, who have admittedly worked on behalf of PROP in the past. PROP heavily influenced the creation and implementation of the 2016 CDC Guideline, which was systematically misapplied over the last three years by lawmakers, health insurers and pharmacies in a way that became harmful to many patients with chronic pain,” said Dr. Chad Kollas, a palliative care specialist in Florida.

“Failing to disclose authorship of the AHRQ report reduces the agency’s transparency in a way that raises alarms for those familiar with the misapplication of the CDC Guideline and seek to prevent recurrent harm to patients suffering from chronic pain.”

Chou did not respond to requests for comment for this story. He recently served on a state task force that recommended a rigid tapering policy that would have forced many Oregon Medicaid patients off opioids and into withdrawal. The policy was scaled back after a backlash from patients and pain management experts, who said the recommendations were not supported by evidence or compassionate.  

“Compassionate sounds good but it’s a loaded term,” was Chou’s response at the time. “I don’t think there’s anything compassionate about leaving people on drugs that could potentially harm them.”

On a recent podcast, Chou said there was little of evidence to support the use of opioid medication.

DR. ROGER CHOU

“The impact of prescription opioids in terms of mortality and substance use disorder and all the other things that come along with it have really been quite staggering.  We have more evidence that the benefits of opioids are really not as large as we’d like them to be. In most studies, they’re actually quite small and often clinically insignificant,” he said.

Chou also claimed in the May 2019 interview that the opioid hydrocodone was “the number one prescribed drug in the United States and has been for many years.” That statement is false. Since 2011, hydrocodone prescriptions have fallen dramatically – as they have for all opioids -- and it is now the fifth most widely prescribed drug in the U.S., ranking behind cholesterol, thyroid and blood pressure medications.

Public Comment Period Ends

On Tuesday, the AHRQ ended a 30-day public comment period on its draft report. Unlike other federal agencies that routinely seek public comments in the Federal Register, the AHRQ only accepted comments on its website. The agency did little to publicize the draft report outside of a mass email to 100,000 subscribers notifying them the report was available for comment. 

One critic who had a chance to see the AHRQ’s review of over 150 opioid studies said it was filled with errors, biases and cherrypicked research – much like the CDC guideline that Chou co-authored.

“In laymen’s terms, AHRQ and CDC have been caught with their fingers on the balance scales, in a deliberate and unconscionable effort to bias public policy against the use of opioid therapies regardless of the medical evidence,” Lawhern said in a written public comment.  “CDC violated its own research standards by failing to explicitly acknowledge that the medical evidence for alternatives to opioids is no stronger than for opioids. Now AHRQ proposes to compound that lack of public transparency by doubling down on a false narrative.”

Although voluntary, the CDC’s dose recommendations have been widely misapplied by insurers, pharmacies, doctors, and federal and state regulators – who have adopted the guideline as policy or even law — and used it as an excuse to abruptly cutoff or taper patients on opioids.

“We are concerned that the AHRQ review may have similar unintended consequences,” the American Medical Association said in a letter to the agency. The letter points out that most opioid overdose deaths are caused by illicit fentanyl and other street drugs, not prescription opioids.

“We would suggest that AHRQ publish the list of all those involved in any aspect of the report... to help remove any perception of potential conflict.”

— Dr. James Madara, AMA

“The AMA urges the AHRQ to clarify that the review does not support a conclusion that the epidemic of opioid-related overdose deaths is due to efforts to treat patients with chronic pain or cancer pain, or to manage pain for patients receiving hospice or palliative care,” said Dr. James Madara, the AMA’s Executive Director and CEO. “The AMA further urges the AHRQ to clarify that this review should not be used to justify or support reductions in opioid therapy for patients with acute, chronic, palliative, cancer-related or other pain when clinically indicated by the patient’s physician.”

The AMA’s letter also urged the AHRQ to publicly identity everyone the agency consulted with before its final report is released.

“We would suggest that AHRQ publish the list of all those involved in any aspect of the report during the comment period to help remove any perception of potential conflict,” Madara wrote.

PROP President Discloses Conflicts of Interest

By Pat Anson, PNN Editor

The president of Physicians for Responsible Opioid Prescribing (PROP) – an influential anti-opioid activist group – has worked as a paid consultant for the national law firm of Motley Rice, which stands to make billions of dollars in contingency fees from opioid litigation.

Dr. Jane Ballantyne disclosed her work with Motley Rice in a revised disclosure statement recently made public by the Annals of Internal Medicine, a prominent medical journal. Ballantyne co-authored an op/ed in the journal in September that called for “every patient receiving long-term opioid therapy” to be assessed by doctors for tapering off the drugs.

In her original conflicts of interest statement, Ballantyne did not disclose her work for Motley Rice, her affiliation with PROP or any other conflicts. 

“In a recent Ideas and Opinions commentary, Dr. Ballantyne did not disclose that she has received personal fees for the multidistrict opioid litigation because her consultancy in the litigation was under a confidentiality agreement. Dr. Ballantyne has now updated her disclosure because her role in the multidistrict litigation has since become public knowledge,” the medical journal said in a statement.

Ballantyne did not disclose the amount of compensation she received from Motley Rice.

Dr. Anna Lembke, a Stanford psychiatrist who co-authored the Annals article, said in her initial disclosure statement that she was also a paid expert witness in opioid litigation, but did not reveal what law firm she works for. In a new statement, Lembke discloses that she is a PROP board member.

“In the spirit of full transparency, Drs. Ballantyne and Lembke have decided to disclose their involvement in Physicians for Responsible Opioid Prescribing (PROP) as well. PROP is a 501c3 charitable organization. Their roles are volunteer positions without financial remuneration,” the journal said.

The claim that PROP is a 501c3 non-profit organization is puzzling because PROP is not a registered charity with the Internal Revenue Service. Instead it uses the Steve Rummler Hope Network as its "fiscal sponsor" -- an IRS designation that allows PROP to piggyback onto another organization’s 501c3 status. Because it is not a charity, PROP has never filed a federal or state tax return and is not required to disclose anything about its revenue, donations or spending.

Ballantyne and Lembke are not the first PROP members to revise their financial disclosure statements or to work as paid consultants in opioid litigation. PROP founder and Executive Director Dr. Andrew Kolodny recently revised his conflict of interest statements for the Journal of the American Medical Association (JAMA) to include his work in opioid malpractice lawsuits.  

DR. JANE BALLANTYNE

Ballantyne, a retired anesthesiologist and professor at the University of Washington School of Medicine, is a controversial figure in the pain community because of her role in drafting the CDC’s controversial 2016 opioid prescribing guideline. Many blame the guideline for a surge in suicides by patients who were abandoned by their doctors or forcibly taken off opioids.

Although Ballantyne was known to have strong negative opinions about prescription opioids and worked in the past as a paid consultant for Cohen Milstein Sellers & Toll  -- another law firm involved in opioid litigation – she was still allowed to serve on the “Core Expert Group” that advised the CDC when it drafted the guideline. Several other PROP members also served as advisors to the CDC, which the agency did not disclose until it was threatened with a lawsuit.

Lucrative Sideline

As PNN has reported, working as a paid consultant or expert witness has become a lucrative sideline for Kolodny and other anti-opioid activists. The lawyers that hire them are eager to have them testify in opioid litigation cases that will likely reward their law firms with billions of dollars in contingency fees.  

Kolodny recently testified as the “star witness” for Oklahoma in its opioid negligence lawsuit against Johnson & Johnson. For that, he was paid $725 an hour by Nix Patterson & Roach, one of three law firms hired by Oklahoma to handle the case against J&J. Kolodny, who stands to make up to $500,000 for his testimony in the Oklahoma case, also acknowledged working as a consultant for Cohen Milstein at a rate of $725 an hour.

Cohen Milstein and Motley Rice are lead counsels in a national opioid litigation case in Cleveland that has consolidated about 2,600 lawsuits filed by states, cities and counties against opioid manufacturers and distributors. According to Legal NewsLine, the law firms could take home 40% of any settlements, which are projected to reach about $50 billion.

“The firm that stands to win the most will likely be Motley Rice, which pioneered the strategy of joining forces with government attorneys to sue the tobacco industry in the 1990s. Motley Rice name partner Joe Rice has never revealed his personal take from the $260 billion tobacco deal but private lawyers in total will receive $14 billion from the multi-year agreement,” Legal Newsline reported.   

Ohio Attorney General Dave Yost has complained that legal fees in the opioid litigation case are too high. The judge has also warned attorneys to fly coach and limit their hotel rooms to $450 a night.

Many of the lawyers involved in the case are major political donors. Motley Rice attorneys gave over $700,000 to political candidates in 2018, while the law firm of Simmons Hanly Conroy donated over $1 million, much of it going to Missouri Sen. Claire McCaskill (D) in her failed bid for reelection.

Coincidentally, McCaskill released a report last year that was sharply critical of physician and patient advocacy groups for accepting money from opioid manufacturers. Three organizations cited in the McCaskill report — the American Academy of Pain Medicine, American Geriatric Society, and the American Pain Society — were named as defendants in opioid lawsuits filed by Simmons Hanly.  

High Number of Youths Using Rx Opioids

By Pat Anson, PNN Editor

A large new analysis of drug use by teenagers and young adults in the U.S. has found a surprisingly high level of prescription opioid use. In a survey of over 56,000 youths, researchers found that 21% of teens and 32% of young adults said they had used opioid medication in the past year.

"The percentages were higher than we expected," said first author Joel Hudgins, MD, of Boston Children's Hospital's Division of Emergency Medicine. "They really highlight how common use of prescription opioids is in this vulnerable population."

The data from the 2015-2016 National Survey on Drug Use and Health doesn’t necessarily reflect the environment that exists today. Opioid prescriptions have fallen by 43% since their peak and last year alone declined by a record 17 percent. Many pain patients — of all ages — now have trouble getting opioids prescribed and filled.

During the study period, nearly 4% of teens and 8% of young adults reported misusing prescription opioids or having an opioid use disorder.

Misuse was defined as using opioids “in any way that a doctor did not direct you to use them,” while a use disorder was classified as recurrent use that causes significant impairment and failure to meet major responsibilities at home, work or school.

Researchers were surprised by some of the findings, which are published in the online journal PLOS One. Among youths who reported misusing prescription opioids, 57% said they obtained them from friends or relatives and only 25% percent came from healthcare providers.

"In previous studies in adults, opioids were more commonly obtained from a physician," Hudgins says. "Our findings show that the focus of prevention and treatment should include close friends and family members of adolescents and young adults, not simply prescribers."

Youths who misused opioids, particularly the young adults, often reported using other substances, including cocaine (36%), hallucinogens (49%), heroin (9%) and inhalants (30%). At least half had used tobacco, alcohol, or cannabis in the past month.

In a previous study, the same researchers found relatively high rates of opioid prescribing to youths visiting emergency rooms and outpatient clinics. About fifteen percent of youths were given opioids during ER visits from 2005 to 2015.

"Given these rates of opioid use and misuse, strong consideration should be given to screening adolescents and young adults for opioid use when they receive care," says Hudgins.

More recent surveys have found a steady decline in the misuse of prescription opioids by young people. The most recent Monitoring the Future Survey found that only 3.4% of high school seniors misused opioid medication in 2018.

Misuse of Vicodin and OxyContin among 12th graders has fallen dramatically over the past 15 years, from 10.5% in 2003 to 1.7% in 2018 for Vicodin, and from 4.5% in 2003 to 2.3% in 2018 for OxyContin.   

Feds Using ‘Cone of Silence’ Again for Rx Opioid Review

By Pat Anson, PNN Editor

Federal health officials are at it once again, releasing a draft report on the risks and benefits of opioid pain medication without seeking substantive input from the public or medical community.

So far they’ve done it with no public hearings, feeble attempts at soliciting public comment, and without disclosing the identities of the experts they consulted with.

If that reminds you of the CDC’s botched rollout of its opioid guideline in a comically secretive webinar that one critic compared to Get Smart’s “Cone of Silence” – you’re not alone.

Or as agent Maxwell Smart said to his boss, “You know this thing doesn't work, why do you always insist on using it?”

This time it’s not the CDC, but a little-known research agency in the Department of Health and Human Services called the Agency for Healthcare Research and Quality (AHRQ).

Last month, AHRQ quietly released a 287-page draft report on the effectiveness of opioid medication in treating chronic pain.

Like the CDC, the AHRQ concluded that evidence on the long-term effectiveness of opioids is limited, but there was enough evidence to warn of “increased risk of serious harms” at high doses.  Even when used short-term for acute pain, the report found “no differences between opioids versus nonopioid medications in improvement in pain function, mental health status, sleep, or depression.” In other words, Tylenol is just as effective as Vicodin.

Who is the author of the AHRQ report? What experts were involved in drafting it? Who are the peer reviewers? We don’t know because the AHRQ won’t identify any of the participants until the final report is released.

According to the draft report, “Key Informants” and “Technical Experts” that consulted with AHRQ were required to disclose financial or professional conflicts of interest. But even if they had conflicts, they were not automatically disqualified by AHRQ because “individuals with potential conflicts may be retained” due to their “unique clinical or content expertise.”

‘Identifying Authors Not Essential’

An AHRQ spokesman told PNN that the agency does not identify the researchers and experts it consults with until after a final report is released.

“This policy is aimed at helping the authors maintain their independence by not being subject to lobbying by industry reps or others with conflicts of interest, either financial or intellectual,” Bruce Seeman said in an email. “AHRQ maintains that identifying the authors is not essential to the primary goal of receiving comments on the science of the reports.”

But critics of the policy say the refusal to identify participants only raises doubts and suspicion. It is also eerily similar to what the CDC did in 2015, when it released a draft of its controversial opioid guideline without identifying the “core expert group” it consulted with.

It turned out few of the CDC’s experts had any experience in clinical pain management and several had conflicts, such as being affiliated with Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group. Faced with allegations that it violated federal open meeting laws, the CDC created a new expert panel and delayed releasing the final guideline for several months.

“I would hope that they, the AHRQ, would be able to provide far more notice and transparency as it relates to both substance and process than what was provided by the CDC and its secret Core Expert Group in the development of their ‘Guideline’ for Prescribing Opioids,” said Stephen Ziegler, PhD, a Professor Emeritus at Purdue University. “Governments rarely evaluate their own policies to see if they work or cause unintended harms. That needs to change.”  

“This failure to identify authorship in the draft essentially disqualifies the document. Without knowing who wrote and reviewed this document, we cannot identify their biases or predispositions,” said Richard “Red” Lawhern, PhD, a patient advocate with the Alliance for the Treatment of Intractable Pain (ATIP).

“If anyone among these groups was also among the writers group that supported CDC in 2015-2016, then we have reason for concern that the AHRQ comparative review will be equally biased and unsupported by real research. It should be noted that no less an authority than the American Medical Association has publicly repudiated many of the assumptions and all of the core methodology incorporated into the Guidelines.” 

Lawhern emailed a “flash alert” to ATIP members this morning, urging them to comment on the AHRQ draft report while there is still time. Unlike other federal agencies that routinely seek public comments in the Federal Register, where they would get broader exposure, the AHRQ is seeking comments on its own website. Comments will be accepted until Tuesday, November 12 at noon EDT. 

“We need large numbers of knowledgeable medical professionals, patients and caregivers to file protest at the public gateway,” said Lawhern, who learned of the AHRQ report after being tipped off by a patient. 

The AHRQ sent out no press releases notifying the news media that it was soliciting comments on the draft report. In an online search, this reporter could find no news coverage of the report itself.  

“AHRQ doesn’t issue press releases, publish newsletter articles or pursue other high visibility promotion of draft reports. We normally save those efforts for final products,” said Seeman.

The AHRQ spokesman said the agency did send a mass email on October 17th to about 100,000 subscribers notifying them that the opioid report was available for comment. 

Lawhern says there was not enough transparency or public involvement in the draft process.

“This draft report should be withdrawn immediately and re-published on the regulations.gov website after announcement in the Federal Register.  When re-published, the names and qualifications of all ‘key experts’ and peer reviewers should be disclosed,” said Lawhern.

Limited Evidence

In drafting the report, the AHRQ’s experts reviewed over 150 clinical studies and reviews of pain patients prescribed opioids. Few of the studies were long-term, an evidence gap that exists not only for opioids but for all medications used to treat pain. Long-term studies are lacking because it would be unethical for researchers to knowingly treat someone’s severe pain with a placebo — which would essentially amount to torture.

The old saying that “absence of evidence is not evidence of absence” would seem to apply to the effectiveness of opioid medication, but not in the AHRQ’s draft report. “Limited evidence” is repeatedly cited as a reason not to use opioids, while similar low-quality evidence is cited as proof that opioids are risky. 

“Limited evidence indicated no differences between long- and short-acting opioids in effectiveness, but long-acting opioids were associated with increased risk of overdose,” the report concludes.

“For patients with chronic pain, opioids are associated with small beneficial effects versus placebo but are associated with increased risk of short-term harms and do not appear to be superior to nonopioid therapy. Evidence on intermediate-term and long-term benefits remains very limited and additional evidence confirms an association between opioids and increased risk of serious harms that appears to be dose-dependent.”

Lawhern says the AHRQ is cherry picking the evidence. 

“The draft top level summary reveals a deliberate and scientifically unsupported bias against opioid analgesic therapy that continues and expands on the cherry picked ‘research’ quoted in the 2016 CDC guidelines on prescription of opioids,” he said.

Lawhern is particularly concerned about references in the draft to the Krebs report, a controversial study that found opioids no more effective than acetaminophen in treating back or knee pain. Critics say the Krebs study was small, poorly designed and failed to prove anything.

“The profoundly flawed and biased Krebs report is among the references quoted in the draft report. This inclusion by itself would be grounds for deep alarm,” Lawhern said.

1 in 4 Counterfeit Pills Have Lethal Dose of Fentanyl

By Pat Anson, PNN Editor

Illicit drug users who buy prescription pills online or off the street are playing a dangerous game of Russian Roulette, according to a new laboratory analysis by the U.S. Drug Enforcement Administration.

The DEA found that about one of every four counterfeit pills (27%) have a potentially lethal dose of fentanyl, a synthetic opioid that is 80-100 times stronger than morphine.

Counterfeit pills laced with illicit fentanyl are appearing across the country and have been linked to thousands of deaths. Many of the overdoses involve blue pills stamped with an “M” and a “30” – distinctive markings for 30mg fake oxycodone tablets known on the street as “Mexican Oxy” or “M30.”

Based on a sampling of 106 tablets seized nationwide between January and March 2019, the DEA found that 29 of the pills contained at least 2 mg of fentanyl, a potential lethal dose. At least one pill seized in California had 4.2 mg of fentanyl — more than twice a lethal amount.

“Capitalizing on the opioid epidemic and prescription drug abuse in the United States, drug trafficking organizations are now sending counterfeit pills made with fentanyl in bulk to the United States for distribution,” said DEA Acting Administrator Uttam Dhillon. “Counterfeit pills that contain fentanyl and fentanyl-laced heroin are responsible for thousands of opioid-related deaths in the United States each year.”

The DEA laboratory analysis found fentanyl in 21% of the heroin samples tested. Fentanyl is often added to illicit drugs to boost their potency.

‘Enough to Kill Entire Population of Ohio’

In recent months, there have been outbreaks of fentanyl-related overdoses around the country. Law enforcement agencies are also seizing larger amounts of fentanyl from drug traffickers.

In September, DEA agents found a pill press and five pounds of pure fentanyl in a San Diego apartment. Prosecutors said that was “enough to kill the city of San Diego” or about 1.5 million people.

That seizure was overshadowed a few weeks later, when 45 pounds of suspected fentanyl were seized in Montgomery County, Ohio. A Homeland Security agent said that was "enough to kill the entire population of Ohio, many times over."  

Public health officials in Seattle recently warned about a spike in fentanyl-related overdoses that killed at least 141 people in King County, including several teenagers. Parents and students are being warned in public service announcements not to consume any pill not directly obtained from a pharmacy or prescriber.

Last week health officials in Virginia predicted the state would have a record number of drug overdoses in 2019. Most of the 1,550 projected overdoses involve illicit fentanyl.

As in other parts of the country, fentanyl related deaths have surged in Virginia, while overdoses involving prescription opioids have remained relatively flat for over a decade.

“In 2015 statewide, the number of illicit opioids deaths surpassed prescription opioid deaths. This trend continued at a greater magnitude in 2016, 2017, and 2018,” the Virginia Department of Health said in its latest quarterly report. “There has not been a significant increase or decrease in fatal prescription opioid overdoses.”

Survey Repudiates Canada’s Pain Care Policies

By Dr. Lynn Webster, PNN columnist

A recent survey by the Chronic Pain Association of Canada (CPAC) demonstrates all too well that our Canadian neighbors are sharing in the misfortune of America’s man-made crisis in pain care.

The online survey was distributed to patients via social media during a two-month period in the summer of 2019. CPAC received 740 responses from all 10 provinces and the territory of Nunavut. Key findings add to the growing evidence that people in pain are suffering from policies aimed at reducing access to pain medication.

• Almost two-thirds of respondents (64%) reported they have not had adequate pain control in the past two years

• A similar number (66.2%) feel discriminated against and degraded because they require opiate medicines to cope with severe pain

• A third of patients (33.5%) have either been abandoned by their doctors or their doctors have refused to continue prescribing for them

• Close to half (47.8%) have been forced against their will to taper their doses

• Nearly 45% either have deteriorated relations with their medical providers or no longer have a doctor

• Almost 40% were not adequately treated for pain in emergency rooms

Substitutes for opiates have not helped. About 70% of patients surveyed say they are more disabled, can do less with their lives, and their quality of life has declined.

Desperate Solutions

Almost 40% of patients have considered suicide because of the increased pain, while 5.4% have actually attempted suicide. A third of respondents (33.5%) reported that they know of someone who did commit suicide because of increased pain.

One other “desperate solution” is that nearly 10% of patients have substituted dangerous street drugs for what they previously received as safe prescriptions. Nearly a third of respondents (30.8%) reported they know patients who are purchasing street drugs for this reason.

Based on these findings, CPAC Executive Director Barry Ulmer penned a letter to Canada's Minister of Health.

"I’m writing on the first day of Canada’s National Pain Week, when the country notes the tragedy of chronic pain, the right of all Canadians to have their pain relieved, and government’s obligation to ensure appropriate and timely care,” Ulmer wrote.

“Yet two million Canadians with ongoing pain serious enough to warrant treatment with opioid analgesics still suffer profoundly — and pointlessly — because federal policy dismisses their needs. In today’s opioid-averse regulatory climate, their access to care shrinks precipitously as Canada’s pain specialists vanish from practice, and especially from prescribing."

Ulmer's letter further describes how people in pain feel that they are being erroneously blamed for Canada’s overdose problem. Many are being forced to taper or discontinue their pain medications. 

The CPAC findings mirror the results of a U.S. survey by Pain News Network which was released on the third anniversary of the 2016 publication of the CDC opioid prescribing guideline.  

In a critique of Canada’s 2017 opioid guideline – which was modeled after the CDC’s -- the Canadian Family Physician reports the guideline has left the Canadian health care system unable to manage its high-dose opioid patients:  

“However well-meaning they are, the 2017 Canadian opioid prescribing guidelines were introduced to a health care system ill equipped to care for patients with chronic pain. 

Without a clear and implementable patient-oriented strategy, combined with universal training in safe and effective chronic pain and addiction management for all health care providers, well-meaning documents like the 2017 Canadian guidelines might inadvertently harm the very people they hope to help."

As in the U.S., Canadian doctors are refusing to prescribe the opioids that patients need and alternative treatments are insufficient. The pharmaceutical industry is being villainized and health care professionals who prescribe opioids are under pressure to inappropriately adhere to a one-size-fits-all solution for pain patients.  

It is understandable that politicians want to reduce the harm from inappropriate use of opioids, but it should not be at the expense of people in pain. This is a human rights issue that must not be ignored.   

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.”

You can find Lynn on Twitter: @LynnRWebsterMD.

Opinions expressed here are those of the author alone and do not reflect the views or policy of PRA Health Sciences or Pain News Network.

What We Can Learn from Germany About the Opioid Crisis

By Roger Chriss, PNN Columnist  

Germany doesn’t have an opioid crisis. As NBC News reported, 10 times as many Americans as Germans die from drug overdoses, mostly opiates. And while opioid addiction rates in the U.S. have risen dramatically, in Germany they’re flat.

The story of Germany challenges much of the narrative about the American opioid crisis. If addiction moves in lockstep with opioid prescribing, then Germany should have high addiction rates. If prescription opioids lead to heroin use, then Germany should be seeing rising rates of heroin use. And if overdoses are an inevitable consequence of addiction, then Germany should have high overdose rates.

But this is not what is happening. According to a recent PLOS One study, opioid prescriptions in Germany are rising, but there is no “opioid epidemic.”

“Even though patterns of opioid prescription follow trends observed in other developed countries, there are no signs of an opioid epidemic in Germany. Therefore, this review could currently not find a need for urgent health policy interventions regarding opioid prescription practices,” the study concluded.

A report from the European Monitoring Centre for Drugs and Drug Addiction shows that drug overdoses in Germany are falling. There were 1,926 overdose deaths in Germany in 2006 and 1,272 in 2017. Overdoses peaked in Germany over a decade ago.

Rates of drug use in Germany show that cannabis and MDMA (ecstasy) have been trending upward in recent years, amphetamine use is stable, and cocaine use is falling among young adults. In people seeking drug treatment, addiction to cannabis and cocaine are rapidly rising, but opioid addiction fell sharply in 2016 after a rise in the preceding decade.

Yet Germany has the second-highest prescription opioid rate in the world. And if current downward prescribing trends hold in the United States, Germany will have the highest rate by late 2020.

Easier Access to Rx Opioids

But Germany simply isn’t having an opioid crisis, which one expert attributes to the country’s well-established social security network and full health insurance coverage.

“Many specialist pain treatment centres by now will report cases of chronic pain patients with inappropriate opioid therapy, who then have to be weaned off the medication. However these are only isolated cases and there is no increase in inappropriate use of opioids in Germany in general,” Lukas Radbruch, a palliative care physician at University Hospital Bonn in Germany, explained in the BMJ.

Radbruch belongs to an expert committee that regulates and monitors opioid use in Germany.

“In Germany regulations for opioid prescription have been changed throughout the years to allow easier access to these medicines - for example, extending the maximum amount per prescription or the maximum duration of each prescription,” he wrote. “There is consensus in the committee that there is no indication of anything similar to the opioid crisis in the US, and no indication of an increase in inadequate prescribing of opioids in Germany.”

Rhetoric about prescription opioid risks rarely includes the details of prescribing. But it turns out that if patients are given non-opioid options first, then screened and monitored during opioid therapy as is done in countries like Germany, the risks are far lower. The risks are lower still when problems of misuse and signs of addiction are caught early and addressed medically.

In other words, maybe the U.S. has an opioid crisis as a result of doing virtually everything wrong. From excess pharmaceutical marketing and poor patient management to a lack of multimodal pain treatment and addiction care, we almost couldn’t not have had an opioid crisis.

And once the crisis got started, we failed to respond quickly with best practices, in particular the overdose rescue drug naloxone and harm reduction policies. Instead, we embraced doomed tactics like abstinence programs and forced tapering of medications.

The most recent data from the CDC does show some encouraging news. From March 2018 to March 2019, the overdose death rate fell by 2.2 percent. The provisional counts for 2019 show an overall flattening of overdose deaths, but no sustained downward trend.

Most of this progress is in fewer fatalities linked to prescription opioids. But illicit fentanyl is spreading westward, and from San Diego to Seattle a rise in overdose deaths has been seen throughout 2019, much of it caused by counterfeit medication. So the “gains” of last year may quickly evaporate. Fentanyl is cheap to make, easy to distribute, and getting into the entire drug supply. Meth and cocaine are resurging, too.  

The drug overdose crisis is evolving fast. Most overdoses involve multiple substances, often with inadvertent exposure or as a result of counterfeit or tainted drugs. And some are suicides. Now in the vaping outbreak we are seeing the impact of new technologies and new chemicals used in novel ways.

As the RAND Corporation noted in its September report on fentanyl, we need new options fast. Germany’s preventative healthcare, proactive public health monitoring, and coordinated harm reduction policies may provide sound ideas for a sensible response to the rapidly evolving drug crisis in the U.S.

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.

This column 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.

Former CEO of U.S. Pain Foundation Sentenced to Year in Prison

By Pat Anson, PNN Editor

The founder and former CEO of the U.S. Pain Foundation has been sentenced to a year in federal prison for embezzling $1.5 million from the Connecticut-based charity and failing to report the income on his tax returns.

U.S. District Judge Victor Bolden sentenced Paul Gileno to 12 months and one day of imprisonment, followed by two years of supervised release. Gileno pleaded guilty to wire fraud and tax evasion in June.

The 47-year old Gileno is also required to pay full restitution to the charity and the Internal Revenue Service, as well as tax penalties and interest.

"By engaging in wire fraud and tax fraud, the defendant committed very serious crimes over the course of several years,” U.S. Attorney John Durham said in court documents.  

“As the Court is well aware, tax fraud undermines the public’s confidence in the tax system and relies on taxpayers to correctly report all taxable income.  As to the wire fraud offense, the defendant stole money from his employer for his own personal gain.  As such, the defendant’s conduct is very serious."

PAUL GILENO

Gileno faced up to 25 years in prison, but as part of his plea agreement prosecutors agreed to ask for a lesser sentence. In a sentencing memo, prosecutors said Gileno was in “relatively good physical and mental health” and was a hard worker committed to his family.

"I cannot even express how sorry I am for what  have done, I made mistakes, I screwed up majorly, I mismanaged, I was careless and I took money that was not mine, I used it for personal use and I was selfish," Gileno wrote in a letter to the judge. "I took the money and, in my mind, justified it by saying to myself I deserved it at the time and US Pain had it. I justified it in multiple ways."

Gileno's defense attorney also presented numerous testimonies from pain patients and advocates about the help they received from Gileno and his work in patient advocacy.

Gileno will report to prison on January 6, 2020. Until then he is free on bond.

Fraud Went Undetected for Three Years

The money embezzled by Gileno was used to pay his mortgage, car payments, loans to his brothers, and a visit to Universal Studios in Orlando, Florida. The misuse of funds allegedly went undetected for three years.

“I still find it difficult to believe that nobody else who’d been in upper management of the foundation for several years knew anything regarding the going out and coming in of money/funds,” former U.S. Pain board member Suzanne Stewart recently wrote in her blog. Stewart resigned from the board last year because she was concerned about how the charity was being run.

According to an audit and U.S. Pain’s tax returns, Gileno misappropriated over $2 million from the charity from 2016 to 2018.  Nicole Hemmenway, the current acting CEO, was vice-president and board chair at the time. Two other longtime board members, Wendy Foster and Ellen Lennox Smith, still serve as directors. And Lori Monarca remains as Executive Office Manager, according to U.S. Pain’s website.

The board asked for and received Gileno’s resignation in May 2018, although it wasn’t publicly disclosed for several months that financial irregularities were behind his departure.

Since Gileno’s resignation, U.S. Pain says it has taken steps to ensure there was more internal control and financial oversight of its expenses and cash flows.

According to U.S. Pain’s 2018 tax return (the organization’s 2016 and 2017 returns were delinquent and filed late), the charity spent over $1.2 million last year on salaries, employee benefits, lawyers, accountants, tax penalties and business losses. That means less than half of the $2.1 million raised by the charity was spent on programs and services for the pain community.

Earlier this month, U.S. Pain announced the appointment of Shawn Dickens to its board of directors, filling the seat vacated by Suzanne Stewart nearly a year earlier. Dickens is the first U.S. Pain board member who was not appointed by Gileno.