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.

Surgery Patients in Vermont Getting Fewer Opioids or None at All

By Pat Anson, PNN Editor

The 2016 CDC opioid guideline was never intended to reduce the use of opioids for post-surgical pain. In fact, studies show that long-term use of prescription opioids after surgery is rare. Nevertheless, a number of states and hospitals have policies designed to reduce the use of opioids after surgery -- many of them modeled after the CDC guideline.  

Vermont was one of the first, adopting a rule in July 2017 that encourages doctors to use non-opioid pain relievers as first-line treatments for post-operative plan. If they do prescribe opioids, patients are initially limited to no more than 10 pills. The regulations also require doctors to discuss with patients the risk of opioid addiction and overdose.

This state-mandated policy has led to significant reductions in opioid prescribing to surgery patients at the University of Vermont Medical Center (UVMMC) without impacting patient satisfaction in pain management, according to a new study presented at the American College of Surgeons Clinical Congress.

The study evaluated opioid prescribing at UVMMC for 15 common operations for 12 months before the regulations went into effect and for 17 months afterward.

During that period, the daily morphine milligram equivalent (MME) dose declined by 33 percent, from 96 MME to 64 MME afterwards. The proportion of patients who did not receive any opioids after surgery more than doubled, from 12.7 to 26 percent. That’s one of every four patients.

Prescription refill rates for opioids increased from 5.5 percent to 6.3 percent, and the percentage of patients reporting an inadequate amount of pain medication also rose, from 11 percent to 12.3 percent. But those increases were not considered statistically significant by the researchers.

“The clear trend is that physicians are prescribing less, patients are using less, and there is no appreciable change in patient-reported pain control or satisfaction after implementation of these regulations,” said study presenter Mayo Fujii, MD, a clinical instructor in surgery at the University of  Vermont Larner College of Medicine.  

“That patients are using less may reflect the impact of patient education efforts to establish expectations of postoperative pain and use non-opioid pain management strategies, as well as public awareness of the opioid epidemic.”

Patient education about non-opioid analgesia increased from 82 percent to 98 percent during the study period, as did education on safe opioid disposal (19 percent to 52 percent).

“Patient education, particularly encouraging non-opioid pain management strategies was something that clearly increased after these regulations went into effect,” Fujii said. “It’s an intervention that’s easily implemented and may contribute to patients using less opioid medication than they otherwise would have.”

Vermont Overdoses Still Rising

The Vermont regulations appear to have been successful in reducing the frequency and amount of opioids prescribed to both acute and chronic pain patients. But what about their impact on addiction and overdose rates?  The evidence there is mixed at best.

According to state health officials, fatal overdoses in Vermont rose from 96 deaths in 2016 to 110 deaths last year. Most of those overdoses involve illicit fentanyl or heroin, not prescription opioids. Only 28% of the deaths in 2018 were linked to opioid painkillers, but it’s not known if the pills were prescribed or obtained illicitly.

A recent study in neighboring Massachusetts found that only 1.3% of overdose victims who died from opioid medication had an active opioid prescription – suggesting that the vast majority of pills were stolen, diverted or bought on the street.

As in other states, many doctors in Vermont have grown cautious about their opioid prescribing and some are aggressively tapering patients off opioids. A recent study of tapering in Vermont found only 5 percent of patients had a tapering period longer than 90 days. The vast majority (86%) were rapidly tapered in three weeks or less, including about half who were cut off without any tapering. Many of those patients were hospitalized for severe withdrawal symptoms, including respiratory failure.

A new federal tapering guideline suggests tapers of 5% to 20% every four weeks, although slower tapers of 10% a month may be appropriate for patients taking opioids for more than a year.

Why America's Opioid Crisis Is Really a Drug Crisis

By Pat Anson, PNN Editor

A new report from the CDC challenges much of the conventional thinking about the opioid crisis, particularly the role played by prescription opioids. Other medications can be even more risky.

For example, twice as many Americans overdosed on the anti-anxiety drug alprazolam (Xanax) in 2017 than those who died after taking hydrocodone (Vicodin).

Gabapentin (Neurontin), a pain reliever thought to be safer than opioids, was linked to more fatal overdoses than tramadol (Ultram).

And here’s a shocker: the antihistamine diphenhydramine (Benadryl) is the 10th deadliest drug in the United States.

CDC researchers say illicit fentanyl, heroin and cocaine were involved in far more overdoses than any opioid medication. And methadone, an addiction treatment drug that’s supposed to prevent overdoses, was linked to more drug deaths than hydrocodone.

Only three opioid pain medications — oxycodone, morphine and hydrocodone — made the top 10 list of drugs involved in 2017 overdoses.

TOP 10 DRUGS INVOLVED IN 2017 OVERDOSES

SOURCE: CDC

CDC researchers used a text analysis to scan electronic death certificates to find which drugs were most commonly involved in overdoses. The methodology is imperfect, since it includes drugs that were not necessarily the cause of death, but it provides a more thorough picture of which drugs are driving America’s overdose crisis.

The analysis also uncovered distinct regional differences. Deaths from heroin in 2017 were highest in New England, New York, and the mid-Atlantic states, while methamphetamine was the deadliest drug in most of the West, Southwest and Mountain states.

The 2017 analysis is likely already dated, as counterfeit medications made with illicit fentanyl have caused hundreds of overdose deaths this year on the west coast, from San Diego to Seattle.     

Doctors Targeted for Opioid Prescribing

While legal prescription opioids are not involved in most drug overdoses, they continue to be the focus of the Department of Justice and other law enforcement agencies, which mine prescription drug databases looking for signs of suspicious prescribing.

We reported this week on the case of a California pain doctor who paid a $125,000 fine to settle DOJ allegations that he “illegally prescribed opioids.”

“It was extortion and there’s nothing I was able to do about it. It’s sad and pathetic,” said Dr. Roger Kassendorf.

Federal prosecutors built their case against Kassendorf by analyzing prescription data to identify five of his patients who were on relatively high doses of opioids. None of the five were harmed or overdosed while under the care of Kassendorf, who admits his medical records could have been better. He settled to avoid a more expensive court fight.

It’s a familiar story to other doctors who’ve been targeted by regulators or law enforcement.

“If you study every board case and every indictment, they claim inadequate medical records. It’s their fall back in every case, so in case they lose on the facts, they can save face by being the documentation police,” said Dr. Mark Ibsen, a Montana primary care physician. “As with overprescribing, they never define what under-documentation is.”

Ibsen was initially accused by the Montana medical board of overprescribing opioids, but his medical license was suspended for inadequate medical records. Ibsen had to go to court to get the suspension overturned.

“The prescription drug registry is an excellent document in support of the physician. Given that it is a database available to all physicians in each state, it is hard to claim inadequate documentation for any physician,” Ibsen said.

“There are many doctors and nurse practitioners targeted by law enforcement solely because of the amount of opioids they prescribe. This is inappropriate. No one can assess the quality of care by just looking at the amount of drugs a provider prescribes,” says Dr. Lynn Webster, a pain management specialist and PNN columnist. 

“Providers are often forced to accept plea agreements to avoid incarceration, because they don't have the resources to fight the system. They will often do this to protect their families. There are bad doctors who should be put away, but most are trying to do the best they can within a system that is biased against people in pain and opioids.”

The pressure on physicians is so intense that many have lowered doses or stopped prescribing opioids altogether. That’s forcing pain patients to seek treatment with other doctors — who then run the risk of being flagged as a “high prescriber” if they accept new patients who need opioids.

DEA Seeks to Cut Inventories of Opioid Medication

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has announced plans to significantly reduce inventories of opioid pain medication and other controlled substances that drug manufacturers are allowed to maintain. The inventory reductions are in addition to cuts in the production of opioids that the DEA is seeking in 2020.

The proposed regulations, published this week in the Federal Register, would limit “excess quantities of medications” being stored in inventory that might be vulnerable to diversion. Other rule changes would tighten DEA oversight of the manufacturing and distribution of controlled substances.

Under current regulations, drug companies are allowed to keep inventories on up to 50% of their annual sales quota for Schedule I and II controlled substances. That would be reduced to 30% under the proposed rules.

“Practically speaking, this equates to a reduction from half of a year's sales supply allowed to be held as inventory to nearly four months,” the DEA said.

The agency said the smaller drug inventory “is not expected to increase the likelihood of drug shortages,” because more manufacturers are available to increase production if shortages develop.

“The DEA believes a reduction of inventory allowance to 30%, with flexibility to produce up to 45% at any given point in a year, would have minimal impact on registrants while continuing to provide adequate inventory for registrants to respond to fluctuations in demand in pharmaceutical markets,” the agency said.

Last year the DEA allowed drug manufacturers to increase the production of injectable opioids after shortages developed at U.S. hospitals. The shortages became so acute that some hospitals were forced to use acetaminophen and muscle relaxants to treat surgery and trauma pain.

The FDA still has morphine, hydromorphone and fentanyl solutions on its list of drug shortages and there are anecdotal reports of hospitals continuing to ration injectable opioids. 

‘You Are Hurting Pain Patients’

The public has 60 days to comment on the DEA’s inventory proposal. The comments posted so far are mostly from pain patients critical of previous actions by the DEA.

“Why, why, why do you all keep taking meds from people? You are hurting the pain patients who need this medication. Start taking the drugs off the streets not from our doctors,” wrote Christy Ashford.

“The DEA has waged a war against the sickest and weakest members of American society,” wrote Kirsten Klang. “They know that almost all of the fatalities have to do with the integration of counterfeit fentanyl than any other chemical. Yet, the DEA clamps down where it's easy to do so... even if it's wrong... just because it's easy!”

“I would like to know why the DEA thinks it needs more power over the United States citizens. I mean really, don’t they think that they have tormented enough doctors and their patients through this so-called opioid crisis?” wrote Sheryl Cox. “They say that they have no control over the prescriptions that our doctors give us, and that is an outright lie. They do control our doctors by arresting them and prosecuting them needlessly, sending them to prison, and most do not deserve this kind of treatment and abuse.”

The DEA began cutting the supply of opioid medication in 2016 during the Obama administration. The trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third.

Last month, the DEA proposed further cuts in the supply of hydrocodone, oxycodone and three other opioid painkillers classified as Schedule II controlled substances. If approved, the 2020 production quotas would amount to a 60% decrease in the supply of hydrocodone and a 48% percent cut in the supply of oxycodone since 2016.

Cuts in the supply of prescription opioids have coincided with a sharp increase in overdoses from counterfeit medication. In recent months, hundreds of people have died after taking “Mexican Oxy” – counterfeit oxycodone pills made with illicit fentanyl – which are being trafficked in the U.S. from coast to coast.

Pain Doctor on DOJ Settlement: ‘It Was Extortion’

By Pat Anson, PNN Editor

A southern California doctor who paid a $125,000 fine to settle allegations of illegal opioid prescribing says federal prosecutors threatened to ruin his practice and reputation if he didn’t pay up.

“They could care less if I was innocent or guilty. They wanted to see how much they could gouge out of me,” said Dr. Roger Kasendorf, an osteopathic physician who specializes in pain management in La Jolla. “They tried getting $24 million from me until they saw my bank account. I had to hire a good lawyer and pay them too.

“It was extortion and there’s nothing I was able to do about it. It’s sad and pathetic.”

The U.S. Attorney’s Office in San Diego announced the settlement last week in a press release, alleging that Kasendorf “illegally prescribed opioids to his patients.”

“This investigation arose from data analytics tools which allow the Department of Justice to perform a variety of functions, including identifying statistical outliers, such as which doctors prescribe the highest opioid dosages and which doctors prescribe combinations of opioids and other drugs known to increase the risk of addiction, abuse, and overdose,” the office said in a statement.

“Based on the investigation, the United States contends that Dr. Kasendorf wrote prescriptions for opioids, including fentanyl, that were not issued for a legitimate medical purpose and while not acting in the usual course of his professional practice in violation the Controlled Substances Act and the False Claims Act.”

The DOJ statement makes no mention of any patients being harmed or overdosing while under Kasendorf’s care, and no formal criminal charges were filed against him.

Kasendorf says the DOJ’s case was based on inadequate medical records he kept on five of his sickest patients, who were prescribed relatively high doses of opioids for pain. One of the patients has since died from cancer.

“I didn’t know my EMR (electronic medical records) very well. I didn’t keep good notes. And as a result, they went through my notes and said, ‘Oh look you didn’t do this and you didn’t do this.’ I did, but I kept poor documentation,” Kasendorf told PNN.

“Nowadays, if you see any of my notes over the last three years, they’re perfect. But back in the day I didn’t have great notes.”

DR. ROGER KASENDORF

Kasendorf has a simple explanation for why he agreed to settle rather than defend himself in court.

“It was cheaper to pay it than defend it. So, I just paid it,” he said. “If I didn’t settle, they said they would call the DEA and then the state (medical) board. That’s what they said. ‘If you don’t settle, we’re going to make it a lot worse for you.’   

“If I defend myself, I’m risking my (medical) license, even though I don’t feel like I did anything wrong. Now I’m dealing with three separate entities and then I can’t work anymore. So I almost had no choice but to settle.”

“Without reviewing the medical records, I cannot assess the fairness of this outcome,” says attorney Michael Barnes, who is managing partner at DCBA Law & Policy, a law firm that advises healthcare providers. 

“If the physician were merely a big-data outlier because he took on patients with the most complex needs, and if his prescribing were CSA (Controlled Substances Act) compliant, then the behavior of the federal government would fall squarely under the Black’s Law Dictionary definition of extortion.”

That legal dictionary defines extortion this way: “Any oppression by color or pretense of right, and particularly the exaction by an officer of money, by color of his office, either when none at all is due, or not so much is due.”

Assistant U.S. Attorney Dylan Aste, who led the case against Kasendorf, did not respond to a request for comment. As for the doctor’s claim about extortion, a DOJ spokesperson told PNN, “We’re not going to have any comment about that.”

DOJ Threatens Criminal Prosecution

Kasendorf is the latest example of the DOJ’s heavy-handed tactics in fighting the opioid crisis. Dozens of doctors around the country have been arrested and prosecuted for illegal opioid prescribing, many of them targeted by DOJ task forces that use prescription drug databases to identify high-dose prescribers.

"Sometimes the only difference between a doctor and a drug dealer is a white coat," U.S. Attorney Jay Town told reporters after federal raids in April that resulted in criminal charges against 60 practitioners in seven states.

Those cases may be legitimate, but hundreds of doctors who face no charges are still being harassed by federal prosecutors – not because their patients became addicted or overdosed – but because their names turned up in a database search.

In February, U.S Attorneys in Wisconsin sent letters to 160 high-dose prescribers in the state, warning them that “prescribing opioids without a legitimate medical purpose could subject them to enforcement action, including criminal prosecution.” 

“The DOJ treats controlled-medication prescribers, especially big-data outliers, as though they are guilty unless proven innocent.”

— Michael Barnes, attorney

Similar warning letters have been sent to doctors in Georgia, Massachusetts and other states.

“The DOJ treats controlled-medication prescribers, especially big-data outliers, as though they are guilty unless proven innocent,” said Barnes. “Detailed medical records are the only affordable way for a provider to prove his innocence — or at least make the prosecutor think twice about proceeding with criminal charges.”

Although the DOJ lacked credible evidence that any of Kasendorf’s patients were harmed by his care, the lack of detailed medical records was enough to intimidate the doctor into settling on the advice of his attorney. 

“Dr. Kasendorf’s ability to provide high quality pain management to those in need of treatment never was questioned. No charges ever were filed against Dr. Kasendorf,” said attorney Robert Frank. “The government’s allegations arose from an incomplete story of Dr. Kasendorf’s care for a few patients.  No patients suffered any adverse outcomes or complications from his care.   

“Economically, it made sense for Dr. Kasendorf to put an end to yet another Government pursuit of a physician successfully treating patients for true chronic pain problems, in what now has become an opiophobia world brought on by the overzealous promotion of opioids by pharmaceutical companies and misuse of them by relatively few physicians, Dr. Kasendorf excluded.“ 

‘Glad I Found Dr. Kasendorf’

Kasendorf continues to practice medicine and remains in good standing with the Osteopathic Medical Board of California. The board has no record of any disciplinary actions, malpractice judgments or citations against him.

Online reviews of Kasendorf by patients are largely positive.  

“I am so glad I found Dr. Kasendorf. I have dealt with debilitating neck pain for years. Dr. K treated my neck and my pain not only went away, but my headaches and numbness in my fingers went away also. He is very good at what he does,” wrote Gina in a Yelp review.  

“Dr. Kasendorf is one of the most caring pain management doctors I have ever seen, and I have seen a lot of them. He is truly empathetic towards his patients which is very hard to find. He is very strict about his opiate contract rules, but most pain management doctors are nowadays,” wrote Natalie. 

“He fired me from treatment with opiates despite a chronic painful condition,” wrote Gary, who said Kasendorf cut his opioid medication in half and then dropped him for being non-compliant.

“He is afraid the DEA is going to threaten his practice. Suggest you find an MD with the integrity to stand by his patients and stand by his past decision to prescribe opiates.” 

Guilt by Association 

Federal prosecutors initially became interested in Kasendorf not because of his prescribing practices, but because of his association with Insys Therapetics, a controversial Arizona drug maker.  

Insys’ founder and four former executives were recently convicted of bribing doctors with millions of dollars in kickbacks to prescribe the company’s flagship product: Subsys, a potent fentanyl spray that costs about $5,000 for a single day’s supply.

Subsys is only FDA approved for the treatment of cancer pain, but like other drugs it can be prescribed off-label for other pain conditions. Because of its high cost, Medicare and other insurers often wind up paying for Subsys.

Some doctors were paid lucrative speaking fees by Insys to promote Subys, while others were wined and dined at upscale restaurants or taken to a strip club for free lap dances.   

Kasendorf was a promotional speaker and consultant for Insys from 2013 to 2017. For that he was paid over $167,000, according to ProPublica.

“I was starting my practice. I had no money. The fact I was able to earn money through speaking was a miracle for me. That’s what kept me afloat and my family when I first moved here,” said Kasendorf, who moved to California from the east coast after his home was destroyed by Hurricane Sandy.

“And I was actually good at it. They wanted me to go all over the place because they felt I did a good job and was very thorough. I made it entertaining. I’m a very good speaker and I’m very proud of that.”

In addition to Insys, Kasendorf also did promotional speaking and consulting for several other drug companies, including Purdue Pharma, Egalet, Pfizer, Pernix and Indivior. But it was his work for Insys that federal prosecutors focused on.

“I never took bribes. I never got lap dances or all this stuff they were talking about,” Kasendorf told PNN. “This company did a lot of bad things and I completely agree. The problem is their product happens to be very, very good.”  

Subsys was so effective at pain relief that Kasendorf prescribed it to all five patients who were flagged by DOJ investigators.

“After all this time and all this effort, I think DOJ was upset I didn’t have more money.”

— Dr. Roger Kasendorf

It’s not the first time the DOJ has gone after a doctor for prescribing Subsys and making speeches for Insys. In 2017, the DEA raided the home and clinic of Dr. Forest Tennant, alleging that he took kickbacks from Insys and ran a “drug trafficking organization.” Like Kasendorf, no charges were filed against Tennant, who decided to retire on the advice of his attorneys rather than fight a protracted legal case.    

According to Kasendorf, the DOJ initially wanted him to pay a $24 million fine, but prosecutors settled for far less.

“They were so upset when they saw they could only get $125,000. But I sent them all my records and they could see I literally had no money in the bank,” said Kasendorf. “I had to borrow $100,000 from my parents to pay them.

“They almost put me out of business. But after all this time and all this effort, I think DOJ was upset I didn’t have more money.”

Study Finds Only 1.3% of Overdose Victims Had Opioid Prescription

By Pat Anson, PNN Editor

It’s long been a popular belief that prescription opioids fueled the nation’s opioid crisis and play a major role in overdose deaths. The CDC’s 2016 opioid guideline says as much.

“Sales of opioid pain medication have increased in parallel with overdose deaths,” the guideline states. “Having a history of an opioid prescription is one of many factors that increase risk for overdose.”

But a new study by researchers in Massachusetts has turned that theory on its head. Prescription opioids are usually not involved in overdoses. And even when they are, the overdose victim rarely has an active prescription for them – meaning the medications were diverted, stolen or bought on the street.  

“Commonly the medication that people are prescribed is not the one that’s present when they die. And vice versa. The people who died with a prescription opioid like oxycodone in their toxicology screen often don’t have a prescription for it,” says lead author Alexander Walley, MD, a researcher at Boston Medical Center and Associate Professor of Medicine at Boston University School of Medicine.

Walley and his colleagues analyzed nearly 3,000 opioid overdose deaths in Massachusetts from 2013 to 2015, a period when heroin overdoses were surging and the first wave of illicit fentanyl was entering the black market.

Toxicology screens showed that multiple drugs were involved in most of the overdoses, with heroin detected in 61% of the deaths and fentanyl in 45% of them.

Prescription opioids alone were detected in only 16.5% of the overdoses.

The researchers didn’t stop there. They wanted to know if the people who died had prescriptions for the opioid medications that killed them. To their surprise, only 1.3% of them did.  

“We were able to link individuals who died of an overdose to their prescription monitoring program records.  So we could see how many people who died of an opioid overdose had been prescribed a medication at the time of their death. It turns out that was a minority of the patients,” Walley told PNN.

“If it were only the opioids we prescribed that were killing people, then we would have a perfect match between what we prescribed and what people were dying from. But that only happens 1.3% of the time.”

Rx Opioid Myths Exposed

Walley’s study, published in the journal of Public Health Reports, is one of the first to compare overdose toxicology reports with data collected in Prescription Drug Monitoring Programs (PDMPs). The findings strongly suggest that patients with legitimate prescriptions rarely overdose. And they provide a more nuanced and detailed view of what we usually hear about opioid-related overdoses.

For example, only 6% of those who died with oxycodone in their system had an active prescription for it, meaning the other 94% were taking oxycodone that was diverted or perhaps leftover from an old prescription. Active prescriptions for tramadol, morphine, hydrocodone and hydromorphone were found in less than 1% of the people who died with the drugs in their system. 

Interestingly, active prescriptions for two opioids used to treat addiction --- methadone and buprenorphine (Suboxone) – were found in about 3% of overdoses linked to the drugs.

Massachusetts pain patient David Wieland says the study findings confirm what he has long believed about the opioid crisis.

“The results of this study show that PROP (Physicians for Responsible Opioid Prescribing) and the anti-opioid zealots have been misleading the public for years, as it completely blows the myths they have been spinning out of the water,” Wieland said. “For years they have constantly blamed the majority of these overdose deaths on prescription pain medication. Even as prescribing numbers decreased and overdoses only skyrocketed, they still pushed forward with their lies and propaganda.”

Wieland says his own doctor bought into the myths, insisting that 75% of all overdose victims were pain patients who died by taking their opioid medication as prescribed.

“This was his excuse to further take me completely off my medication,” said Wieland. “Think I'm going to have to send this study to him along with a note reminding him about the supposed facts he tried to shove down my throat.”

Dr. Walley says regulators and public health officials should also take note, and that public education campaigns should not solely focus on the risks of prescription opioids. The CDC’s Rx Awareness campaign, for example, warns people about the abuse of prescription opioids, but says nothing at all about illicit opioids.

“Policy makers may too narrowly focus efforts on preventing the misuse of prescription opioids and devote inadequate resources to addressing heroin and illicit fentanyl use,” Walley said. “I think we can see that we don’t just have a prescription opioid problem. We have an illicit opioid problem. And I think our policy should reflect that.”

8 of 10 Doctors Won’t Take New Patients on Opioids

By Pat Anson, PNN Editor

Nearly three quarters of primary care doctors (72%) worry that chronic pain patients will use illicit drugs if they lose access to prescription opioids, according to a new survey by Quest Diagnostics. And 77% believe the stigma surrounding drug addiction impairs patient care.

Despite those concerns about patient stigma and illegal drug use, the online survey of 500 physicians found that 8 out of 10 are reluctant to take on new patients who are currently prescribed opioids.

“Quest Diagnostics undertook this research so that we could provide insights into the evolving drug crisis and the potential role of physicians’ perspectives about their patients in drug misuse and use disorders,” said Harvey Kaufman, MD, Senior Medical Director, Quest Diagnostics.

“We found that primary care physicians, who are on the front lines of the drug epidemic, are well-intentioned but under-prepared and may miss some of the drug misuse risks affecting their patients.”

Quest compared the survey results to an analysis of 4.4 million drug tests ordered by physicians for patients prescribed opioids and other controlled substances. The findings suggest that many physicians have a poor understanding of their patients’ drug use.

For example, Quest found that over half of patients (51%) showed signs of misusing a prescribed drug, yet 72% of physicians believe their patients take controlled medications as prescribed.

Quest broadly defines drug “misuse” by including the absence of a prescribed medication. Many patients choose not to take a drug because they can’t afford it, don’t like its side effects, or feel they don’t need it. Patients required to have drug tests are also not representative of the general population.

Other key findings:

• 62% of doctors believe the opioid crisis will morph into a prescription drug crisis

• 24% of patients combined legal medications with other non-prescribed drugs or illicit substances

• 95% of doctors are confident in their ability discuss drug misuse with patients, but only 55% actually do

• 70% of doctors wish they had more training on how to taper patients off opioids.

• 75% of doctors wish they had more training on addiction

The Quest lab tests also found concerning results about the misuse of gabapentin (Neurontin), an anti-convulsant drug increasingly prescribed to treat pain. Over 13% of patients showed signs of misusing gabapentin in 2018, making it the mostly commonly misused prescription drug.

Nearly 8 out of 10 doctors (78%) said they often prescribe gabapentin as an alternative to opioids, but only 34% were concerned about its misuse.

“A vast majority of physicians recognize the need for more tools to prevent opioid drug misuse and substance use disorders, and that is why many are tightening opioid prescribing and turning to gabapentin as an alternative,” said pain specialist Jeffrey Gudin, MD, Senior Medical Advisor, Quest Diagnostics.

“While gabapentin may not have opioids’ addictive potential, it can exaggerate euphoric effects when combined with opioids or anxiety medications. This drug mixing is dangerous.”

Gabapentin and pregabalin (Lyrica) belong to a class of nerve medication known as gabapentinoids. A recent study found gabapentinoids increase the risk of suicide, overdose, traffic accidents and injuries in younger people. Sales of gabapentinoids have tripled in recent years in the United States, where they are often promoted in prescribing guidelines as safer alternatives to opioids.