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).

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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. 

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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.

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

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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.   

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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.

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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.

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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.

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.

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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.

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“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

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.  

Subsys.png

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.”