Canada’s ‘Deeply Flawed’ Opioid Guideline

By Pat Anson, Editor

Just six months after adopting an opioid prescribing guideline modeled after the CDC's guideline in the United States, they’re already having second thoughts in Canada.

An editorial published in the Canadian Medical Association Journal says the guideline is “deeply flawed,” may have contributed to several deaths, and has created “a climate of fear” among doctors and patients.

Like the opioid guideline released by the Centers for Disease Control and Prevention in 2016, the Canadian version strongly recommends that patients not receive opioid doses in excess of 90mg morphine equivalents daily (MED), and that patients receiving a higher dose by tapered to the “lowest effective dose” or stop getting opioids altogether.

“The Guideline neglects to warn physicians that tapering can put patients at high risk for overdose, because patients will lose tolerance, experience distressing withdrawal symptoms, and turn to other sources for their opioid,” warns lead author Meldon Kahan, MD,  director of addiction treatment at Women’s College Hospital in Toronto.

Kahan helped write Canada’s 2010 opioid guideline, which recommended a much higher ceiling of 200mg MED.  He says the current guideline fails to address addiction or how to treat opioid use disorder with medications such as buprenorphine and methadone.

“By not discussing these treatments, the Guideline encourages physicians to manage opioid addiction through tapering, which is usually ineffective and sometimes dangerous,” wrote Kahan.

“The Guideline is contributing to a climate of fear around opioid prescribing. We are aware of several instances of death following rapid tapering or abrupt discontinuation. The Guideline needs extensive revision to ensure patient safety; until this is done, the medical community and medical regulators must not use the Guideline as the standard for opioid prescribing.”

Over 50 clinicians, academics, patients and “safety advocates” helped draft the Canadian guideline. Among them were three board members of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that played a key role in drafting the CDC guidelines: PROP Vice-President Gary Franklin, MD, Mark Sullivan, MD, and David Juurlink, MD.

One major difference between the Canadian guideline and the CDC’s is that the latter is only intended for primary care physicians, while Canada’s guideline applies to all prescribers, including family physicians, pain specialists and nurse practitioners.

Nearly 1 in 5 Canadians suffer from chronic pain and Canada has the highest rate of opioid prescribing outside the United States. Opioid prescribing peaked in the U.S. in 2010, but prescriptions are still trending upward in Canada. A report released last week by the Canadian Institute for Health Information shows that the total number of opioid prescriptions rose by nearly seven percent between 2012 and 2016, although fewer pills are being prescribed.

Opioid overdoses are soaring in Canada, as they are in the United States, but increasingly the deaths involve illegal opioids such as heroin and illicit fentanyl, not prescription painkillers.

Minnesota’s Tough New Guideline

Canada may be having second thoughts about its guideline, but Minnesota appears close to adopting even tougher rules for prescribers – which would arguably be the most draconian anywhere in the United States.

The draft guidelines released last week by the Minnesota Opioid Prescribing Work Group (MOPWG) would limit new opioid prescriptions for acute, short-term pain to just three days’ supply and a total of no more than 100mg MED – meaning the average daily dose would be less than 34mg MED.

Treatment for acute pain that lasts longer – for up to 45 days – would be limited to a total of 200mg MED every 7 days. Prescriptions would also have to be obtained weekly.

Daily doses for chronic pain lasting longer than 45 days would be limited to 90mg MED – if a patient is able to get them at all. The guideline specifically discourages doctors from prescribing opioids for fibromyalgia, migraine, “uncomplicated” back pain, and just about every other chronic pain condition. It also strongly recommends that  doctors discuss tapering with patients on long term opioid therapy, "regardless of their risk of harm."

“Opioid analgesics should not be used to manage chronic pain. There is very limited shorter-term evidence on the efficacy of opioids for chronic pain management and a growing body of evidence of significant harm associated with use,” the MOPWG said in a statement.

The MOPWG was chaired by Chris Johnson, MD, an outspoken critic of opioid prescribing who is a board member of PROP, as well as the Steve Rummler Hope Foundation.

“If pain doctors still think these medicines are effective, then they have a lot of explaining to do and their competence and professionalism deserve to be challenged,” Johnson said a few months ago.

If opioids are prescribed long term, Minnesota's guidelines recommend that doctors evaluate a patient’s mental health, as well as any history of physical or emotional trauma. The guidelines claim that patients with a history of trauma are more likely to develop chronic pain.

“Patients with chronic pain tend to report higher rates of having experienced traumatic events in their past, compared to people without chronic pain. A traumatic event is an event (or series of events) in which an individual has been personally or indirectly exposed to actual or threatened death, serious injury or sexual violence,” the guideline states.  

“Traumatic events illicit a number of predictable responses, including anxiety, physiological arousal and avoidance behaviors. A growing body of evidence finds that individuals who have experienced trauma may develop a persistently aroused or reactive nervous system. When confronted with an acute injury or pain following a surgical procedure, people whose nervous systems are already in a state of persistent reactivity due to a past trauma may be more likely to transition for acute to chronic pain.”

If adopted, Minnesota’s draft guideline would only apply to patients covered by the state’s Medicaid programs. However, they are expected to influence all prescribers, as well as insurance company policies and state regulatory boards. The guideline is available for public review and comment for the next 30 days.

Are My Good Years Over?

By Louis Ogden, Guest Columnist

My story is a follow-up to the guest column by Kimberley Comfort that was recently published here in Pain News Network.

I am also a patient of Dr. Forest Tennant and, after reading Kimberley’s heart-felt story, I immediately felt compelled to write mine.  I am currently 67 years old and, much like Kimberley, my problems with pain started during childhood.

kristen and louis ogden

The pain waxed and waned until I was in my mid-20’s, when it became a daily part of my life.  I tried very hard to ignore the pain and remained in denial until many years later. I did not even tell my wife at the time. I did realize that I was consuming way too much Excedrin and was aware of the dangers posed by taking too many NSAIDs. 

I went to several doctors seeking help in the 1980s, but none of them could find anything wrong with me.  I worked through the pain until it became impossible for me to continue doing the physical work required of an electrician. The pain was body-wide, but the worst pain of all was constant, crushing headaches that were absolutely paralyzing. 

Deciding that I must change careers, I returned to college.  I was accepted at James Madison University and enjoyed college life so much that after graduation I decided to stay in academia and teach.  I received an academic scholarship to Syracuse University, but was not able to finish my Master’s thesis due to the excruciating pain, an inability to concentrate, and the severe chronic fatigue that often accompanies extreme pain.

Then I started searching again for a doctor that could help me.  My initial diagnosis was fibromyalgia.  I asked that doctor if there were anything he could give me for the pain and his exact words were, “Yes, I could, but you would be a junkie within two weeks.”  He offered no medication or treatment of any kind. 

I kept trying doctor after doctor, and almost every therapy and medication known to science. Nothing helped.

My search finally took me to Dr. Tennant in 2010.  He is considered one of our country’s foremost experts on pain and the prescribing of opioids, having operated a pain clinic in West Covina, CA since 1975.  He is also the Editor Emeritus of Practical Pain Management, a monthly medical journal about pain.  His current research interests are inflammatory markers and the role of hormones in pain care.   He is a frequent speaker at major pain conferences. 

How could I possibly go wrong by having this expert in pain as my doctor? 

When I first saw Dr. Tennant in 2010, he was very blunt with me and told me that I might not live much longer.  By then my severe chronic pain had given me high blood pressure, which can cause heart failure or stroke.  In addition, my lab results were not good.  Dr. Tennant told me that my pain had “centralized” -- meaning that I had suffered the pain so long that it had become my normal state.  Pain that has not centralized will be sporadic, while centralized pain is constant.

DR. FOREST TENNANT

I suffer from a post-viral autoimmune illness that first presented years ago with symptoms similar to fibromyalgia, arthritis, and myalgic encephalomyelitis.  Dr. Tennant began treating me with opioid medication and titrated me to a higher dose to effectively manage my pain.  I had been on a standard dose, but Dr. Tennant found through genetic testing that I have a genetic anomaly that makes me a poor metabolizer of many medications.  This is why I required a high-dose therapy. 

Here is where I differ from Kimberley Comfort.  She metabolizes her medications so rapidly, that she could not reach a level of comfort on a standard dose.  My problem is the opposite – I am a very poor metabolizer -- but the outcome is the same.  We both require high doses to properly treat our pain. 

After years of debilitating constant pain, I began feeling much better.  Opioid medication not only did a good job of relieving the pain, but along with hormone supplements and anti-inflammatory drugs, they also improved my quality of life, allowing me to do things now that I could not do before.  It may sound trite, but this man “gave me my life back.”

In late 2015, I was diagnosed with cancer, the onset of which may have been facilitated by my overall disease state.  More recently, imaging has shown that I have abnormalities of the cervical spine that likely contribute to my continuing complex array of symptoms.  Like most of Dr. Tennant’s patients, I am an outlier – a patient whose complex disease state places me far outside the usual patient, in terms of severity and resulting disability and pain.  I believe that I would probably not be alive today without the thorough assessment, evaluation, diagnosis and treatments provided by Dr. Tennant. 

Now, the DEA has raided his office and seized all of his patients’ records.  I have read the search warrant and was very surprised to find that a family practice physician (not a pain specialist) had advised the DEA. Dr. Timothy Munzing suggests in the warrant that any patient from out of state receiving high-dose prescriptions for opioids must be selling their medications because they could not take those doses and survive.  That is absolutely not true. I’ve been taking these high doses for seven years and have had the best seven years of my adult life. 

Dr. Tennant’s practice is in California and I live in Virginia, so imagine how I feel now. I am quite frankly scared to death of having my door kicked in, my medications seized, and then going into serious withdrawal.  At my age and my level of pain, I could die along with many other patients of Dr. Tennant.  How can the DEA practice medicine?  They have no medical license.  These decisions should be made by the doctor and the patient. 

Dr. Tennant recently received a Lifetime Achievement Award for Pain Medicine from his colleagues at PainWeek.  In making the presentation, Dr. Kevin Zacharoff described Dr. Tennant as “the kind of doctor that listens, digests, and most importantly, invests in every patient, the patient's problems, and those of society."  Zacharoff describes him as “the true doctor's doctor," a term used in years past to mean the kind of physician other physicians would want to seek out for their own medical care.  

Why doesn’t the DEA understand what pain physicians and patients understand about Dr. Forest Tennant?

Louis Ogden and his wife Kristen live in Virginia. Kristen volunteers in Dr. Tennant’s pain clinic and recently wrote a column about why it is such a “special place” for patients and their families.

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

Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.  

Chronic Pain and Depression Common in Overdoses

By Pat Anson, Editor

People who die from opioid overdoses are significantly more likely to suffer from chronic pain and depression, according to a new study that highlights the risk of combining opioid pain relievers with benzodiazepines, a class of anti-anxiety medication.

Researchers at Columbia University Medical Center analyzed over 13,000 overdose deaths among Medicaid patients and found that over 61 percent had been diagnosed with back pain, headaches or some other chronic pain condition. Many also suffered from depression, anxiety, bipolar disorder, schizophrenia and other mental health problems.

Significantly, nearly half of those with chronic pain (49%) filled a prescription for opioid pain medication during the last 30 days of their lives, and just over half (52%) filled a prescription for benzodiazepines. Prescriptions for anti-depressants, anti-psychotics and mood stabilizers were also common.

“This medication combination is known to increase the risk of respiratory depression, which is the unusually slow and shallow breathing that is the primary cause of death in most fatal opioid overdoses," said Mark Olfson, MD, a professor of psychiatry at Columbia and lead investigator of the study.

“Most persons with opioid-related fatalities were diagnosed with one or more chronic pain condition in the last year of life. As compared to people with opioid-related deaths without diagnosed chronic pain conditions, the decedents with chronic pain diagnoses were more likely to have also received substance use and other mental health disorder diagnoses. They were also more likely to have filled prescriptions for opioids, benzodiazepines, and other psychotropic medications and to have had a nonfatal drug overdose.”

The Columbia study included opioid overdoses linked to both pain medication and illegal opioids such as heroin, but was limited to Medicaid patients who died between 2001 and 2007. Since that time, opioid prescribing has declined, while illegal opioids and counterfeit medication have become increasingly available on the black market.

Public health officials have only recently started warning about the risks of combining opioids with benzodiazepines, and some insurers now refuse to pay for the medications when they are prescribed jointly.

A recent study of overdose deaths in Florida found that benzodiazepines such as Xanax and Valium killed nearly twice as many Floridians in 2016 as oxycodone. Another study in Pennsylvania also found that overdose deaths involving benzodiazepines exceeded those from opioid painkillers.

The Columbia study was published online in the American Journal of Psychiatry. The study was funded by the Agency for Healthcare Research and Quality, the National Institute on Drug Abuse, and the New York Psychiatric Institute.

GAO Seeks Expanded Tracking of Medicare Rx Opioids

By Pat Anson, Editor

A new report to Congress by the Government Accountability Office (GAO) recommends that the federal government greatly expand the monitoring of Medicare patients who receive high doses of opioid pain medication, as well as the doctors who write their prescriptions.

If adopted, an estimated 727,000 Medicare beneficiaries who receive opioids in excess of 90mg morphine equivalent doses (MED) would have their prescriptions tracked by private insurers and reported to the Centers for Medicare & Medicaid Services (CMS). Critics say such a policy would have a chilling effect on doctors, who increasingly fear government sanctions for prescribing opioids.

In 2016, over 14 million elderly and disabled Medicare patients received an opioid prescription, and CMS spent over $4 billion paying for their opioid medication.

“A large number of Medicare Part D beneficiaries use prescription opioids, and reducing the inappropriate prescribing of these drugs is a key part of CMS’s strategy to decrease the risk of opioid use disorder, overdoses, and deaths,” the GAO report says.

“Despite working to identify and decrease egregious opioid use behavior — such as doctor shopping — among beneficiaries in Medicare Part D, CMS lacks the necessary information to effectively determine the full number of beneficiaries at risk of opioid harm.”

Under current CMS policy, patients are only considered “at risk” if they receive high dose opioid prescriptions from four or more providers and have them filled at four or more pharmacies. Last year, 11,594 Medicare beneficiaries met that criteria, a tiny fraction of those who receive opioids.

The GAO wants to change the criteria so that everyone prescribed a high dose would be monitored, regardless of how many doctors or pharmacies they use.  The principal author of the report said the recommendation is not aimed at taking patients off opioids or lowering their dose, but to improve the data on high dose prescribing.

“We are suggesting that CMS take a close look and monitor and track the numbers of people at risk of harm,” Elizabeth Curda, Director of GAO Health Care, told PNN. “We’re not suggesting CMS investigate 700,000 people who get more than 90mg per day. We want them to focus on how many people are getting these doses and what’s happening to that number. Is it going down? Is it going up?  We have this strategy to reduce harm, so we want to see it coming down.”

“Frankly this is unbelievable.  It is very hard for me to understand how reducing the amount of opioids to people in pain is going to help reduce the amount of smuggled heroin and fentanyl into the United States,” says Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine.  “We need to remember 3 out of 4 drug overdoses do not involve a prescription opioid.  And most of the overdose deaths involving prescription opioids are not in people prescribed the medications.”

Webster is also concerned about a GAO recommendation that Medicare insurers be required to identify and report to CMS all high-dose opioid prescribers. Currently, there’s only a voluntary reporting system when doctors are investigated for fraud, waste or abuse.

“Investigating doctors who prescribe high dose opioids will have a chilling effect.  It will deter all providers from treating people with pain at any dose.  People will suffer.  There will be more suicides because of inadequately treated pain. This is not hyperbole,” said Webster. 

“The whole notion that reducing dose will solve the opioid crisis is misguided.  People who benefit from the high doses will be denied pain relief and those who use any dose for non-medical purposes will just seek illicit and more lethal drugs.”

Patients and Prescribers Ignored

Critics of the GAO report are also disturbed that the agency did not consult with any pain sufferers, patient advocacy organizations or professional medical organizations that represent prescribers. Instead, the GAO met primarily with insurance companies, regulators and addiction treatment specialists.

"We interviewed officials from the largest six health care plan sponsors: Aetna, Cigna, CVS Health, Express Scripts, Humana, and United Health Group," the GAO report says in a footnote.

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

The GAO would not identify any of the individuals it met with, saying the interviews were conducted on a “not for attribution” basis to encourage frank discussion. However, it seems likely that Andrew Kolodny, MD, was interviewed, as he is the founder and Executive Director of PROP, works at Brandeis University, and is considered by some to be an expert on opioid abuse.

Kolodny, who is the former chief medical officer of the addiction treatment chain Phoenix House, did not respond to a request for comment. Pain News Network is filing a request under the Freedom of Information Act with the GAO to disclose who they talked to.

ANDREW KOLODNY, MD

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

“They even go so far as to invite one solo participant who is an ‘expert on opioid abuse.’ It’s as if they were asking representatives from the sugar industry to help develop guidelines on when artificial sweeteners should be used. Clearly, this speaks to a policy that is concerned with driving down opioid prescribing across the board, without considering the needs of the people with pain who actually benefit from opioid analgesics. It’s wrong, and everyone with a stake in pain management should demand that they start allowing us to sit at the table, rather than just to be on the menu.”

“It appears the GAO did not include patients, professional pain organizations and the American Medical Association in their deliberations. I would like to know how they feel their process can be justified,” added Webster. “They only invited groups to comment that appear to benefit financially from reduced prescribing or are opposed philosophically to opioids for non-cancer pain treatment.”

The only professional medical organization the GAO did consult with, the American Society of Interventional Pain Physicians, represents doctors who typically specialize in spinal injections and surgery.

The GAO’s Elizabeth Curda downplayed the role of people who were interviewed, telling PNN they were “not a major part of our methodology” in preparing the report.

Pain patients and pain management experts are often excluded or ignored when federal decisions are made about pain care.

The Centers for Disease Control and Prevention failed to consult with patients or practicing pain physicians while drafting its 2016 opioid prescribing guideline and secretly holding many of its deliberations.  The CDC also ignored a warning from its own consultant that some doctors stopped prescribing opioids after the guideline was issued.

Patients and doctors were also excluded from a closed door meeting of the Healthcare Fraud Prevention Partnership -- an obscure federal advisory group – when it met in "special session" last year to discuss Medicare's opioid prescribing policies. As PNN reported, major insurers like Aetna, Anthem, Cigna and Humana were invited to attend, but no other stakeholders in pain care were asked to appear or to share their insights.

More recently, President Trump’s opioid commission released its final report without taking any public testimony from pain sufferers, patient advocates or pain management physicians.

DEA Tactics Questioned in Tennant Raid

By Roger Chriss, Columnist

Agents with the Drug Enforcement Administration recently raided the offices and home of Dr. Forest Tennant, a prominent pain physician in California. According to an affidavit the DEA filed in support of a search warrant, Dr. Tennant is “profiting from the illicit diversion of controlled substances” and is part of a drug trafficking organization that has “submitted millions of dollars in fraudulent Medicare prescription drug claims.”

Dr. Tennant, who was recently honored with a lifetime achievement award,  has not be charged with a crime and denies doing anything wrong.  He says the DEA is out to smear his reputation and those of other doctors who prescribe opioid pain medication.

The DEA’s mandate includes protecting the public from inappropriate distribution of drugs, including opioids, and securing the supply of all controlled substances. But the DEA’s methods have long been scrutinized and found wanting.

A study from 2008 identified 725 doctors who were charged with offenses involving opioid medication. Of those, about 40 percent were general or family practice physicians, and only 3.5% were board-certified pain specialists.

A 2016 study attempted to quantify the nature of these investigations. Researchers analyzed 100 cases of allegedly improper opioid prescribing and found that most of the physicians were male (88%); over 40 years of age (90%); non-board certified (63%); and nearly all were in small private practices (97%). A little over half of the doctors (54%) were said to have “self-centered personality traits.”

A thorough review of the legal issues involved in improper opioid prescribing came to several important conclusions. First, that the “information available about physician misprescribing is in small supply.” This alone is surprising, since the DEA, as well as the FDA, state medical boards and pharmacies would seem well-equipped to have very granular data about opioid prescribing practices.

Next is the “4D Model” of investigations, which typically group “misprescribers” into four categories: dated, duped, disabled or dishonest. The model emerged in the late 1970s from work by addiction medicine experts, but has been shown to be dysfunctional at best, and arguably even damaging to both pain medicine specialists and chronic pain patients.

In particular, the 4D Model cannot readily be applied to misprescribing because “dishonest” is too vague and narrow. As a result, “for liability to attach to physicians, they must prescribe controlled substances knowingly; without a legitimate medical purpose; and outside the course of professional practice.” As the raid on Dr. Tennant suggests, these criteria are not always satisfied, as his very sick patients will attest.

But the DEA is empowered to investigate as it sees fit. The DEA says the “types of cases in which physicians have been found to have dispensed controlled substances improperly under federal law generally involve facts where the physician’s conduct is not merely of questionable legality, but instead is a glaring example of illegal activity.”

Prosecution of Doctors Increasing

Since 2008 the DEA has been adding agents and resources to its ranks. From the review article, “the squads increased investigations, inspections, and administrative actions significantly” and “the number of criminal malpractice prosecutions in this area has also risen.”

That is having a substantial impact on the world of pain management. Although investigations are certainly warranted in cases like pill mills, rogue doctors, and illegal online pharmacies, most DEA investigations do not result in criminal charges. But even a warning letter from the DEA to one physician at a healthcare facility can have a chilling effect on prescribing practices in the entire facility. Thus, the DEA’s actions can ripple out to chronic pain patients far removed from the target of an investigation.

It is also important to note that DEA investigations and resulting charges are often dismissed. In a blog post  in support of Dr. Tennant, pain management expert Dr. Lynn Webster recounts his own experience with a DEA investigation that was dropped four years after it began.

“The DEA wanted information, but even more, they wanted to exhibit a show of force to intimidate my patients, employees, and me,” said Webster.

In Florida, Dr. Debra Roggow was caught up in a pill mill investigation, mostly based on the amount of opioids she prescribed. Roggow was ultimately acquitted of all charges, but not until her reputation and practice were ruined.

"This has been a horrifying, humbling experience," she said. "I was worried, of course. I knew of my innocence, but innocent people do go to jail."

There is a vast gulf between a legitimate pain specialist like Dr. Tennant and a pill mill.

As Sam Quinones describes in his book Dreamland, “If you see lines of people standing around outside, smoking, people getting pizza delivered, fistfights, and traffic jams—if you see people in pajamas who don’t care what they look like in public, that’s a pill mill.”

Misprescribing opioids is not a well-studied or well-understood problem. This is peculiar, given that it is now 20 years since the start of the opioid crisis. The current 4D Model is flawed, and given the influx of heroin and illicit fentanyl into the country, the DEA does not seem to be fulfilling its mission statement of “reducing the availability of illicit controlled substances on the domestic and international markets.”

The raid on Dr. Tennant’s practice may be part of a legitimate operation, such as the investigation of Insys Therapeutics and its fentanyl product Subsys. But if so, that arguably could have been accomplished without the drama of DEA agents swarming into a small medical practice or breaking into the home of a respected 76-year physician while he and his wife were out of town.

A spirit of cooperation between physicians and law enforcement would go a long way to help pain management specialists and their patients in the opioid crisis.

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

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

Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.  

Tennant Patients Say DEA ‘Attacked a Good Man’

By Pat Anson, Editor

Ryle Holder wants the DEA to know that he’s not a drug dealer or a money launderer.

And he’s doesn’t think his physician, Dr. Forrest Tennant, is one either.

“They’ve gone and attacked a good man. He’s such an empathetic person for so many people. You just can’t find doctors that care like he does,” says Holder.

As PNN has reported, Tennant’s home and pain clinic in West Covina, California were raided last week by DEA agents, after a judge signed off on a search warrant that alleges Tennant is part of a drug trafficking organization and running a pill mill.

The raid stunned the pain community nationwide, because the 76-year old Tennant is widely known and respected for his willingness to see intractable pain patients who can’t find effective treatment elsewhere.  

“It’s not like he’s just giving out high doses of medication and running a pill mill, like they said. That to me was the most asinine statement in that whole search warrant,” says Holder.

FOREST TENNANT, MD

Like many of Tennant’s patients, Holder suffers from adhesive arachnoiditis and Reflex Sympathetic Dystrophy (RSD), two chronic and painful conditions that are considered incurable.  For the last three years, the 48-year old Georgia man has been flying to California every few months to see Tennant.

Although Holder is not identified by name in the search warrant, it strongly implies that he and a handful of other patients were selling the opioid pain medication that Tennant prescribed and diverting the profits back to Tennant.

“For them to even remotely think I’m out on the streets selling this stuff is a joke. It makes me angry,” says Holder, who is a licensed pharmacist. “I’ve got a license to protect. That’s the last thing I’d do.

“It’s like everything else they do. They don’t talk to any patients. They don’t talk to any doctors. They just go and throw all this stuff out there and making all these incriminations against people. They don’t have any evidence that I’ve sold anything. It’s just ludicrous.”

Also named in the search warrant is United Pharmacy of Los Angeles and pharmacist Farid Pourmorady of Beverly Hills, the owner of United. Click here to see a copy of the search warrant.

“Investigators believe that United, Tennant, and various medical practitioners are profiting from the illicit diversion of controlled substances, including the powerful narcotic fentanyl, which are prescribed and dispensed other than for a legitimate medical purpose,” DEA investigator Stephanie Kolb states in lengthy affidavit.

stephanie kolb

Although Tennant has been under investigation for nearly three years, much of the evidence against him appears circumstantial. Kolb and medical consultants hired by the DEA identified “very suspicious prescribing patterns” that include high doses of opioids that were regularly prescribed to patients who live out-of-state.

“My review of the data shows what I recognize to be red flags reflecting the illicit diversion of controlled substances,” said Kolb, who according to her LinkedIn profile was self employed as a dog walker and pet groomer before she started working for the DEA in 2012.

“Many patients are traveling long distances to see Dr. Tennant, some as far away as Maryland and Louisiana,” Dr. Timothy Munzing says in the affidavit. "These prescribing patterns are highly suspicious for medication abuse and/or diversion. If the patients are actually using all the medications prescribed, they are at very high risk of addiction, overdose, and death.”

Dr. Munzing is a family practice physician who has worked as a medical consultant for the DEA since 2014. Munzing doesn't hide his strong feelings about opioids and says in his Medscape profile that he wants to be "involved with law enforcement in trying to attack the opioid crisis."

Munzing has established a lucrative business for himself as a consultant for the federal government. According to GovTribe, a website that tracks payments to federal contractors, Munzing is paid $300 an hour by the DEA to testify as an expert witness and reviewing patient records. Munzing was paid about $45,000 by the DEA during the period Tennant's prescribing records were under review.   

timothy munzing, md

"Many well-meaning physicians prescribed high-dose opioids because of a lack of, or erroneous, education and experience, being naïve or exceedingly busy, or not recognizing the dangers that existed," Munzing wrote in a recently published paper. "This resulted in drug overdoses and death. A very small proportion of patients began selling their prescribed opioid medications for profit."

No Patients Harmed

Unmentioned anywhere in the affidavit is that it is common for Dr. Tennant to prescribe high doses of  medication to his patients because most are in extreme pain and some are dying.  Many travel from out-of-state simply because Tennant is the only doctor willing to see them.  Also unmentioned is any evidence that a patient overdosed or was harmed while under Tennant’s care.  Nor is any evidence presented that a patient sold their medication.

The omission of those important details from Kolb’s affidavit – whether by design or ignorance -- may have influenced Judge Alicia Rosenberg’s decision to sign the search warrant on the afternoon of November 13. Coincidentally, that was the same day Tennant was testifying 1,200 miles away in Montana as a defense witness in the trial of Dr. Chris Christensen, another doctor accused by the DEA of prescribing too many opioids.

Tennant and his wife Miriam returned home the next evening to find the front door of their house had been kicked in by DEA agents.

“We can’t tell you how very sorry we are that you are a new DEA target! We feel somewhat responsible for this travesty, since they obviously knew you were in Montana on our behalf,” Dr. Christensen and his wife wrote in an open letter to Tennant posted on Facebook.

“It’s our very firm belief that the DEA’s course is to attack all those practitioners, who stand in opposition to their intrusion into the practice of medicine.  It is my contention that the DEA will spare no effort to conceal its catastrophic failure to interdict the flow of counterfeit pharmaceuticals into the United States over the past decade. Therein lies the true cause of increasingly severe opioid addiction and opioid related deaths.”

The DEA raids on Tennant's home and pain clinic were widely publicized in Montana after his testimony, just as a jury was about to begin deliberations in the Christensen case. Yesterday the jury found Christensen guilty of negligent homicide in the deaths of two patients.

Subsys Connection  

A major part of the DEA’s case against Tennant hinges on nearly $127,000 in speaking fees that he was paid by Insys Therapeutics, a controversial Arizona drug maker that makes a potent fentanyl spray called Subsys.

Several company officials have been indicted on federal charges that they bribed doctors with kickbacks and lucrative speaking fees to get them to promote Subsys, which has been implicated in hundreds of overdose deaths.  

Tennant says he stopped taking payments from Insys in 2015 and was dropped from the company’s speaker’s bureau last year.

“What money we did make, we put in the clinic and used it to support the patients,” he told PNN.

Subsys is only approved by the FDA for the treatment of cancer pain, but Insys aggressively marketed the spray to have it prescribed “off label” to treat other pain conditions. It’s perfectly legal for physicians to prescribe a drug off-label – in fact it’s a common practice – but Tennant drew additional scrutiny because he prescribed Subsys to several of his non-cancer pain patients.

Subsys is an extremely expensive drug – a single prescription for one of Tennant’s patients cost over $21,000. According to the DEA, nearly $2 million in prescriptions for Subsys were written by Tennant for just five patients. One of them was Ryle Holder.

“It did help a little bit, but it wasn’t doing anything more than what I was already taking,” says Holder, who stopped using Subsys after six months. He was shocked to discover how much his insurance was billed for Subsys.

“I was absolutely blown away. I’ve never in my life as a pharmacist seen anything price-wise even remotely like that. I don’t know if that’s the true price or not, or if they were inflating the price. Who knows? I was shocked when I got it and saw that’s what they had billed,” Holder said.

“I certainly had no comprehension of how expensive this thing had become,” said Tennant, who bristles at the notion that Subsys should be limited to patients with cancer pain.

“It was an excellent product. It still is, for some people it’s just essential,” says Tennant. “Every doctor in the country should be disturbed about this. Are they saying off label use is now a crime?”    

Patients Support Tennant

Tennant has not been charged with a crime and can still practice medicine. But he’s been informed by the DEA that medical records seized from his pain clinic will not be returned directly to him. Patients must request a copy of their records from the DEA if they wish to continue seeing Tennant.

Many are vowing to do just that.

“Before seeing Dr. Tennant I was in and out of the emergency room constantly. I had no idea what was wrong with me at the time and it was not only extremely painful, but I really just wanted to die,” says Dawn Erwin, who Tennant diagnosed with arachnoiditis.

courtesy montana public radio

“He took time to explain it. He told me he could help get it under control. And he has! Not by opiates, but by anti-inflammatory meds, magnets, copper, vitamins, hormones. This has all been life changing for me. I no longer am in the emergency room. I no longer wish to die. I have some of my life back and I have Dr. Tennant to thank. This man has literally saved my life.”

“I remember the first time I told my doctor I felt like I had bugs crawling under my skin. He looked at me like I was crazy, but not Dr. Tennant. He said yes that is all part of the adhesive arachnoiditis and we can see what we can do to help with that,” says Candy Eller. “The creams he recommended, the blood work and hormones he prescribed, the magnet therapy and light therapy, and exercises that he prescribed have helped so much with getting my pain under control.”

“Dr. Tennant is the only doctor that I have found that is willing to treat my rare, complex, incurable medical issues,” says Erin Taylor, who lives with Ehlers-Danlos Syndrome and an autoimmune disease. “I saw over 20 doctors, tried over 15 different invasive treatments, and tried well over 40 different medications in an effort to improve my quality of life. I was most often met with doctors that had no interest in working with such a complicated case.

“To restrict Dr. Tennant’s ability to practice would have a devastating impact on my life, my family’s life, and lives of many more.  Please know that if you chose to eliminate the one doctor that is working to help my debilitating illness, you will be taking away my ability to be mother, wife, daughter, friend, and functioning member of society. I will be bed bound, just a shell of who I use to be.”

For the record, Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.  

Florida’s Deadliest Rx Drug is Not a Painkiller

By Pat Anson, Editor

A new report from Florida’s Medical Examiners Commission is debunking a popular myth about the overdose crisis.

The most deadly prescription drugs in the state are not opioid painkillers, but benzodiazepines – a class of anti-anxiety medication that includes Xanax (alprazolam) and Valium (diazepam).  Xanax alone killed more Floridians last year (813) than oxycodone (723).

The medical examiners analyzed toxicology and autopsy results for 11,910 people who died in Florida in 2016, noting not only what drugs were present at the time of death, but which drug actually caused the deaths.

The distinction is important and more accurate than the death certificate (ICD) codes often used by the CDC, which merely list the drugs that were present. Critics have long contended that CDC researchers cherry pick ICD data to inflate the number of deaths "involving" or "linked" to opioid medication, in some cases counting the same death twice.   

Florida made an effort to get the numbers right.

“Florida’s medical examiners were asked to distinguish between the drugs determined to be the cause of death and those drugs that were present in the body at the time of death. A drug is indicated as the cause of death only when, after examining all evidence, the autopsy, and toxicology results, the medical examiner determines the drug played a causal role in the death,” the report explains.  “A decedent often is found to have multiple drugs listed as present; these are drug occurrences and are not equivalent to deaths.”

The five drugs found most frequently in Florida overdoses were alcohol, benzodiazepines, cocaine, cannabinoids and morphine. The medical examiners noted that heroin rapidly metabolizes into morphine, which probably led to a substantial over-reporting of morphine-related deaths, as well as a significant under-reporting of heroin-related deaths.

Benzodiazepines also played a prominent role as the cause of death, finishing second behind cocaine as the drug most likely to kill someone.  Benzodiazepines were responsible for almost twice as many deaths in Florida in 2016 than oxycodone. Like opioids, benzodiazepines can slow respiration and cause someone to stop breathing if they take too many pills.

DRUG CAUSED DEATHS IN FLORIDA (2016)

Source: Florida Medical Examiners Commission

As in other states, deaths caused by cocaine, heroin and illicit fentanyl have soared in Florida in recent years. In just one year, the number of overdose deaths there jumped 22 percent from 2015 to 2016.

"We don't talk about it much now there's the opioid crisis, but cocaine and alcohol are still a huge issue, there are still a lot of deaths due to those things," Florida addiction treatment director Dustin Perry told the Pensacola News Journal.

Florida is not an outlier. Several other states are also using toxicology reports to improve their analysis of drugs involved in overdose deaths and getting similar findings.  In Massachusetts, deaths linked to illicit fentanyl, benzodiazepines, heroin and cocaine vastly outnumber deaths involving opioid medication.  Prescription opioids were present in only 16 percent of the overdose deaths in Massachusetts during the second quarter of 2017.

SOURCE: MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH

Although it is becoming clear that many different types of drugs -- opioids and non-opioids -- are fueling the nation’s overdose crisis, politicians, the media and public health officials still insist on calling it an “opioid epidemic” or an “opioid crisis” -- diverting attention and resources away from other drugs that are just as dangerous when abused.  We never hear about a Xanax epidemic or a Valium crisis.

President Trump's opioid commission recognized the need to improve drug overdose data when it released its final report this month.

"The Commission recommends the Federal Government work with the states to develop and implement standardized rigorous drug testing procedures, forensic methods, and use of appropriate toxicology instrumentation in the investigation of drug-related deaths. We do not have sufficiently accurate and systematic data from medical examiners around the country to determine overdose deaths, both in their cause and the actual number of deaths,” the commission found.

DEA Raids Dr. Forest Tennant’s Pain Clinic

By Pat Anson, Editor

Agents with the Drug Enforcement Administration have raided the offices and home of Dr. Forest Tennant, a prominent California pain physician, confiscating patient records, appointment books and financial documents.

In a lengthy search warrant, the DEA alleges that Tennant prescribed such high doses of opioids and other medication that his patients must be selling them.  It also alleges that Tennant took financial kickbacks from Insys Therapeutics, a controversial Arizona drug maker that is under federal investigation.

An affidavit by a DEA investigator makes no mention of a patient overdosing or being harmed in any way while under Tennant's care.

“It’s very lengthy and it goes into things in my past which are totally irrelevant but are obviously designed to smear me and make me look like a bad person. I see what they’re doing,” Tennant told PNN.

dr. forest tennant (courtesy montana public radio)

Tennant, who has not been charged with a crime, believes Tuesday's raid is part of a broader effort to smear not only his reputation, but to discredit and intimidate other doctors who prescribe opioids to pain patients.  

“They’re not just going after me, they’re going after patients," said Tennant. “I think the country better understand what they’re doing here. They’re saying that regulations don’t count, standards don’t count, and they’ll decide who can get drugs and how much.

“I’d be worried about every pain patient right now, not just mine.”

Also named in the search warrant is United Pharmacy of Los Angeles and pharmacist Farid Pourmorady of Beverly Hills, the owner of United. Court documents indicate the DEA's investigation began in 2015 and targets a "drug trafficking organization" (DTO) that includes United and "multiple physicians whose prescriptions are filled at United, focusing in particular on Tennant."

"The crimes perpetrated by the DTO include the sale of powerful prescription narcotics such as oxycodone and fentanyl, along with other dangerous and addictive controlled drugs often sought in combination with narcotics, based on invalid prescriptions issued by practitioners including Tennant," the documents say. "United has been submitting millions of dollars in fraudulent Medicare prescription drug claims, namely, claims for the cost of filling invalid narcotic prescriptions, including those issued by Tennant."

The search warrant identifies about $2 million in prescriptions written by Tennant that were filled at United for just five patients, three of whom live out-of-state. Tennant told PNN in a phone interview that the allegations were bizarre.

"I have no financial relationship with anybody. My clinic is fundamentally almost a charity," he said.

Tennant is a revered figure in the pain community because of his willingness to see patients with intractable chronic pain who are unable to find effective treatment elsewhere or have been abandoned by their doctors. At 76, Tennant could have retired years ago, but regularly sees about 120 patients at his modest pain clinic in West Covina, a Los Angeles suburb. Many patients travel from out-of-state to see him, and some are in palliative care and expected to die within a year.   

Tennant, along with his wife and office manager, Miriam, jokingly refers to their clinic as a “mom and pop” operation, although in actuality he practices on the frontlines of pain management and has developed treatment protocols for difficult and incurable conditions such as adhesive arachnoiditis, Ehlers-Danlos syndrome and Reflex Sympathetic Dystrophy (RSD).

Those treatments sometimes require high doses of opioid pain medication, but they also include hormone replacement, anti-inflammatory drugs and other therapies that help patients reduce their use of opioids.

Tennant says he carefully screens his patients and follows all regulations. He has been an outspoken critic of efforts to limit opioid prescribing and recently appeared on a Las Vegas TV station saying the federal government doesn't care if pain patients suffer and die.

“I understand what (DEA is) after. They figure if they go after the big guy, then no one will prescribe,” Tennant told PNN. “If they’re going to hurt me, no doctor is going to be willing to prescribe or do anything. That’s what they’re attempting to do. They’re attempting to neutralize me if they can. And I think there needs to be an outcry.

"The time has come. Is this country going to treat pain patients or not? Are they going to let people die in pain or are they not?"

Ironically, the raid on Tennant’s offices and home occurred the day after he testified in Montana as a defense witness in the trial of another doctor accused of negligent homicide in the overdoses of two patients. The Tennants arrived home Tuesday night to find the front door to their home had been kicked in by DEA investigators.

“It seems like a coincidence, doesn’t it?” Tennant said.

Insys Payments

Tennant acknowledges getting about $126,000 from Insys Therapeutics, payments that were primarily for speaking at events sponsored by the company.

Insys makes an oral spray called Subsys that contains fentanyl, a potent synthetic opioid. Subsys is only approved for the treatment of cancer pain, but Insys aggressively marketed Subsys to have doctors prescribe it “off label” to treat other pain conditions, allegedly resulting in hundreds of overdose deaths.

Several company officials, including Insys’ billionaire founder, have been indicted on federal charges that they bribed doctors with kickbacks and lucrative speaking fees to get them to promote Subsys.  

Tennant says he stopped taking payments from Insys in 2015 and was dropped from the company’s speaker’s bureau last year.

“What money we did make, we put in the clinic and used it to support the patients,” he said.

Tennant says he can still operate his clinic, but has been informed by the DEA that his charts and patient records will not be returned directly to him. Tennant is asking all of his patients to contact the DEA and request a copy of their medical records so that he can continue treating them. 

The DEA's contention that Tennant's patients are selling their opioid medication is preposterous, according to 64-year old Gary Snook, a Montana man who lives with adhesive arachnoiditis, a painful inflammation in his spinal nerves.

“The last thing I’m going to do is sell my medication,” says Snook, who was on an extremely high dose of opioid medication before he started seeing Tennant. “Dr. Tennant has me on such a low dose that I’m just barely getting through the month anyway. I don’t have any to sell.  

“He’s actually been able to lower my dose by about 80 percent, with his hormone therapy and stuff. I’m afraid these guys are sadly mistaken because he’s been moving patients in the opposite direction than they’re suggesting.”

Snook has a genetic condition that makes him a “high metabolizer” of opioids – meaning he has to take a high dose to get any kind of pain relief. His current daily dose is still about three times more than the highest amount recommended by the CDC.

 “I’m not selling mine. I’m just taking it to survive because it’s the only thing that works for my pain. I’ve tried all the modalities and unfortunately this is the only thing that works,” Snook said.

For the record, Dr. Tennant and the Tennant Foundation have given financial support to Pain News Network and are currently sponsoring PNN’s Patient Resources section.  

Senators Pressed DEA to Cut Rx Opioid Supply

By Pat Anson, Editor

A group of 16 U.S. senators played an influential role in getting the Drug Enforcement Administration to make further cuts in the supply of opioid pain medication, the latest example of how politicians have inserted themselves into the healthcare choices of Americans.

As PNN reported, the DEA published an order last week in the Federal Register that cut the 2018 production quotas for Schedule II opioid painkillers by 20 percent. It’s the second year in a row the DEA has ordered steep reductions in the supply of opioids. The move affects several commonly prescribed medications that millions of pain patients rely on for relief, such as oxycodone, hydrocodone, morphine and codeine.

The DEA acted even after drug makers and patients warned the agency that the cuts were so severe they could lead to shortages of pain medication. Under federal law, the DEA sets production quotas for manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more.

The 16 senators – 15 Democrats and one independent – have been urging the DEA for months to go even further to reduce the risk of opioid painkillers being abused.

“As the gatekeeper for how many opioids are allowed to be sold legally every year in the United States, we commend DEA on taking initial steps last year to lower production quotas for the first time in a generation,” Democratic Sen. Dick Durbin of Illinois wrote in a letter to DEA Acting Administrator Chuck Rosenberg on July 11.

“However, the 2017 production quota levels for numerous schedule II opioids remain dramatically higher than they were a decade ago.  Further reductions, through DEA’s existing quota-setting authority, are necessary to rein in this epidemic.”

SEN. DICK DURBIN

Durbin’s letter was co-signed by 15 of his Senate colleagues: Sherrod Brown (D-OH), Amy Klobuchar (D-MN), Edward Markey (D-MA), Joe Manchin (D-WV), Dianne Feinstein (D-CA), Claire McCaskill (D-MO), Patrick Leahy (D-VT), Tammy Baldwin (D-WI), Jeanne Shaheen (D-NH), Kirsten Gillibrand (D-NY), Catherine Cortez Masto (D-NV), Maggie Hassan (D-NH), Richard Blumenthal (D-CT), Al Franken (D-MN) and Angus King (I-ME).

Durbin followed up with a personal meeting with Rosenberg at DEA headquarters on August 3. The meeting was also attended by Senators Brown, Shaheen, Manchin, Markey and Hassan.

“I commend Administrator Rosenberg for acknowledging that the DEA can do more to keep dangerous painkillers off our streets,” Durbin said in a statement after the meeting.  “In today’s meeting, I asked him to continue this effort and further lower the opioid quotas for 2018.  Fewer pills on the market means less addiction and, hopefully, fewer deaths.”   

The August 3 meeting is important, because the very next day the DEA announced it would publish a notice in the Federal Register that it was planning a 20% reduction in Schedule II opioids for 2018.

rosenberg (left) meeting with durbin and other senators

The notice opened up a 30-day public comment period on the DEA’s proposal. Over a hundred people wrote in, most of them pain sufferers who warned the DEA it was going too far.

“The quotas for 2017 caused some shortages at pharmacies. I do not understand the reasoning behind more aggressive production quotas for 2018. People I know who are long term chronic pain patients have gone to the pharmacy for their prescription and are told that it will be a week or 10 days to fill the prescription,” wrote Marjorie Zimdars-Orthman. “It is cruel to implement quotas that will cause pharmacy shortages.”

“This is just beyond insane. Far too many people are already suffering and committing suicide due to not being able to get proper pain management,” said Eric Busch. “Even those that find a doctor willing to actually treat the pain humanely and write a prescription, might not be able to fill said prescription if there are artificial quotas and shortages.”

“How can the government ensure that these quotas will not adversely affect pain patients?” asked Brian Teer, whose wife has suffered from chronic pain for nearly 20 years. “I implore you to consider the medical needs of unfortunate patients like my wife, who face the burden of untreated intractable pain. Please do not reduce the production of the very medications that she needs to continue living. Please do not take her life.”

The DEA said three unidentified drug makers also made comments, warning that the 2018 quotas for codeine, fentanyl, hydrocodone, methadone, morphine, oxycodone and oxymorphone “were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States.”   

The only comment left in support of the 2018 production quotas included a second letter from Durbin and his colleagues, warning that opioid supplies “remain far too high.”

“Given everything we now know about the threat posed by opioids and DEA’s downstream efforts to tackle this problem, there is no adequate justification for the volume of opioids approved for the market,” the letter said.

In the end, the DEA sided with the 16 senators, ruling that the 2018 opioid quotas were “sufficient” to meet the needs of patients. The agency dismissed the comments from pain sufferers as medical complaints that were “outside of the scope” of its final order.

“These one hundred and six comments did not provide new discrete data for consideration, and do not impact the original analysis involved in establishing the 2018 aggregate production quotas,” wrote Robert Patterson, who became acting head of the DEA after Rosenberg resigned unexpectedly in September.

Opioid Quotas Should ‘Continue to Come Down’

Sen. Durbin and his colleagues are apparently not done yet, and may seek to rein in the supply of opioids even further in 2019.

Durbin recently joined with Sen. Markey in introducing the Opioid QuOTA Act, a bill that seeks more transparency from the DEA in disclosing how it sets opioid production quotas. The legislation would require the agency to list on its website the production quota for each opioid manufacturer, information that the DEA now considers confidential.

“The public deserves the right to know which drug companies are manufacturing these opioids, how many they are producing each year, and their justification for asking the DEA to approve their ever-increasing quota requests,” Durbin said in a statement.

“Our work will not be done until these quotas continue to come down, doctors become more judicious in their prescribing, drug companies stop misleading the public about their products, and we do more to help those who are currently addicted get treatment.”

Along with Durbin and Markey, the legislation is co-sponsored by Senators Manchin, Brown, Shaheen and Hassan – the same group of senators that met with the DEA administrator in August and pressed him to make further cuts in the opioid supply.

DEA Cutting Rx Opioid Supply in 2018

By Pat Anson, Editor

The U.S. Drug Enforcement Administration is going ahead with plans to reduce the supply of many opioid painkillers by 20 percent next year. That’s in addition to steep cuts in opioid production quotas the agency imposed in 2017.

In a notice quietly published this week in the Federal Register, the DEA said it would reduce the supply of many commonly prescribed Schedule II opioid painkillers, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, codeine, and fentanyl. The agency said demand for the medications had dropped.

In proceeding with the cuts, which were first proposed in August, the DEA dismissed warnings from three drug makers that the reduced supplies of opioids “were insufficient to provide for the estimated medical, scientific, research and industrial needs of the United States.”

The DEA received over 100 public comments on its proposal, most of them expressing concern that any further reduction in opioids would adversely impact the availability of prescription painkillers.

“I am 75 years old, have metastatic prostate cancer in my bones and have to take high doses of fentanyl patches and morphine tablets for the chronic, intractable pain. Please do not further reduce the supply of my critical medicine,” wrote Bill Daniel.

“Please stop this misguided attempt to save people from themselves. If demand is down, it's because you bullied physicians into prescribing less, not from a genuine market conditions,” wrote one anonymous poster.

“You want to cut my access to the medication I'm legally prescribed by my pain management doctors! Would you consider the same for people deemed disabled due to other illnesses? You are going to cause millions of us to either commit suicide due to unbearable pain or turn to street drugs,” said Christa Rood.

The DEA said comments such as these dealt with medical issues that were “outside of the scope” of its order and did not offer any new data for the agency to consider.

Under federal law, the DEA sets production quotas for all manufacturers of opioid medication and other controlled substances. This year the agency reduced the amount of almost every Schedule II opioid medication by 25 percent or more. The 2017 quota for hydrocodone, which is sold under brand names like Vicodin, Lortab and Lorcet, was reduced by a third.

Those cuts were not sufficient to stop the opioid epidemic, according to two letters sent to the DEA by a group of U.S. senators. The first letter, sent in July, urged that "further reductions... are necessary to rein in this epidemic.”

A second letter, sent in September, said there was "no adequate justification for the volume of opioids approved for the market." The senators asked to DEA to make the 2018 cuts in the opioid supply at least as deep as they were in 2017. 

Opioid prescriptions have actually been in decline for several years.  According to the Centers for Disease Control and Prevention, opioid prescribing in the U.S. has fallen by 18 percent since 2010.  

In recent years, heroin and illicit fentanyl have emerged as the driving forces behind the overdose crisis, which killed an estimated 64,000 Americans in 2016. Despite that, federal efforts to prevent overdose deaths remain largely focused on reducing the use of prescription painkillers.

The CDC, for example, is spending $4.2 million on an Rx Awareness campaign in four states; running ads on billboards, radio, newspapers and online that warn about the risks of prescription painkillers. Although a recent CDC study found fentanyl was involved in over half the overdoses in ten states, the agency says it has no plans to include fentanyl or heroin in its awareness campaign.

“Our aim with this campaign is to prevent prescription opioid overdose deaths, since prescription opioids continue to be involved in more overdose deaths than any other drug. Based on studies of people entering treatment, the majority of people with opioid use disorder (including heroin use disorder) still start with prescription opioids,” CDC spokesperson Courtney Lenard said in an email.

Painkiller Study Conducted at Poorly Rated Hospital

By Pat Anson, Editor

Over-the-counter pain relievers are just as effective as opioid medication in treating short-term acute pain in a hospital emergency room, according to a widely touted study published in the Journal of the American Medical Association (JAMA).

The study was relatively small – only 416 patients participated – and it was conducted at a New York City hospital with a poor history of pain care. Still, it's getting a lot of media coverage. “Milder pill may be best for pain” is the front page headline in the Los Angeles Times. “Drugstore pain pills as effective as opioids” said STAT News. “Opioids Not the Only Answer for Pain Relief” reported HealthDay.  

Researchers said patients with moderate to severe acute pain in their arms or legs got just as much pain relief after being given a combination of acetaminophen and ibuprofen than those who took hydrocodone, oxycodone or codeine. The study only measured pain relief for two hours.

Patients with sickle cell disease, fibromyalgia, neuropathy or any type of pain that lasted more than seven days were excluded from the study because researchers only wanted to focus on short term pain.

"Although this study focused on treatment while in the emergency department, if we can successfully treat acute extremity pain with a non-opioid combination painkiller in there, then we might be able to send these patients home without an opioid prescription," said lead author Andrew Chang, MD, a professor of emergency medicine at Albany Medical Center.

"We know that some patients who are given an opioid prescription will become addicted, so if we can decrease the number of people being sent home with an opioid prescription, then we can prevent people from becoming addicted in the first place."

What Chang, JAMA and the news reports all fail to mention is that the study was conducted at one of the worst hospitals in the nation. In an annual survey of Medicare patients, Montefiore Medical Center in New York City was given only one star (out of five possible), placing it in the bottom 2.44% of hospitals nationwide.

Montefiore was rated poorly on a variety of quality measures, including pain care. Only 64 percent of the patients treated there said their pain was “always” well controlled, compared to the national average of 71 percent.

‘Worst Hospital in the Entire City’

Many of the online reviews of Montefiore’s emergency room are scathing.

“Please do not come to the ER unless you want to die or are used to unsympathetic health professionals,” warned Amanda G. on Yelp.  “I have severe abdominal pain and I'm walking home in tears right now. I came in told the nurse there my symptoms and she couldn't have made it clearer that she couldn't care less.”

“This has to be the worst hospital in the entire city. The nurses in the ER are rude and don't care about your well being. The ER is filthy. People stacked on top of each other,” wrote Robert in a Google review.

MONTEFIORE MEDICAL CENTER PHOTO

“The emergency room sucks. The doctors sit around on the computers gossiping. I even overheard a few doctors saying ‘why aren’t we picking up patients?’ Meanwhile there’s a room full of patients not being taken care of. There’s a patient screaming for help and no one hears him. All the staff members just walk by him,” wrote Zoe D. on Yelp.

“Somebody told me this place was the equivalent of going to a hospital in Manhattan. They lied! I went to the emergency room today for chest pains, I ended up sitting there for four hours never to be seen by a doctor. I ended up walking out and leaving still with my chest pains,” said Phonz R. on Yelp.

“Their ER department is horrible. I went to the ER with my mom via ambulance, we got there (a little) before 1pm. Fast forward 1:58 in the morning she still wasn't put in a room,” wrote J.L. Eaddy on Google. “This was the absolute worst ER I've ever encountered. And I NEVER want to come back again. I wish I had the option to give it negative stars.”

Unfortunately, complaints such as these are not unusual in busy, urban teaching hospitals like Montefiore.  And not all the reviews are poor. U.S. News and World Report gave high rankings to Montefiore in a number of areas, although it didn’t specifically rank its emergency department. Montefiore was recently given a lukewarm “C” rating by the Leapfrog group, a non-profit that grades hospitals on quality and safety.  

Many pain patients have poor experiences in hospitals. In a survey of nearly 1,300 patients by PNN and the International Pain Foundation, over half rated the quality of their pain care in hospitals as either poor or very poor. About two-thirds of the patients said non-opioid pain medications were ineffective.

3 Reasons the Opioid Crisis is Getting Worse

By Roger Chriss, Columnist

The opioid crisis is now a public health emergency. The CDC reports increasing rates of fentanyl overdoses.  And The Economist warns the crisis is entering “a new and deadlier phase.”

The strategy to stop the overdose epidemic has largely focused on the supply side: limiting access to prescription opioids. History seems to support this idea. Two hundred years ago, a tincture of opium called laudanum was widely used to treat all kinds of ailments.  The “epidemic of laudanum” didn’t end until 1906, when the federal government got involved and started regulating opium-based medications.

So it seemed natural to curtail opioid prescribing. Washington State issued prescription opioid guidelines in 2010, Oregon in 2012, and the CDC in 2016. Other states followed with laws limiting the number of days opioids could be prescribed for short term, acute pain. Health insurers like Kaiser Permanente and Intermountain Healthcare have also reduced coverage of prescription opioids and drug store chains like CVS will be limiting prescription length and dose. 

In a narrow sense, this is working. Prescription opioid levels peaked in 2010, as a result of lower production quotas mandated by the DEA and reduced prescribing in a variety of clinical settings.

But in a broader sense, the focus on prescription opioid levels is failing. Opioid addiction and overdose rates continue to climb, despite the reduced availability of prescription opioids. There are three reasons for this.

First, the main drivers in the crisis are now heroin and illicit fentanyl. Importantly, heroin is increasingly the first opioid of abuse.

“As the most commonly prescribed opioids - hydrocodone and oxycodone - became less accessible due to supply-side interventions, the use of heroin as an initiating opioid has grown at an alarming rate,” researchers recently reported in the journal of Addictive Behaviors.

Second, according to the National Survey on Drug Use and Health, approximately 75% of all opioid misuse starts with people taking medication that was not prescribed to them. These pills are sourced from friends, stolen from other people’s prescription bottles, or purchased online illegally.

Contrary to common belief, opioid therapy for chronic pain conditions rarely leads to misuse or addiction. Most addictive behaviors start during adolescence, usually with substances like alcohol or tobacco, long before anyone gets their hands on opioid medication.

Third, nearly 10% of drug overdoses are intentional.

"Hidden behind the terrible epidemic of opioid overdose deaths looms the fact that many of these deaths are far from accidental. They are suicides,” wrote Dr. Maria Oquendo, President of the American Psychiatric Association, in a blog for the National Institute on Drug Abuse.

In other words, the crisis may have started with prescription opioids, but it has evolved. We are now facing a crisis driven primarily by heroin, illicit fentanyl, and other street drugs, as well as social and economic conditions that have led to an "epidemic of despair."

Therefore, the current intense focus on prescription opioids -- from the CDC’s Rx Awareness campaign to the recommendations of the President Trump’s opioid commission -- is woefully off target. Reducing access to prescription opioids has not decreased addiction and overdose rates, and may actually be making them worse.

Exactly what will be required to end the crisis is not clear. But an essential step is to understand the nature of the crisis as it stands today so as to end the opioid disconnect.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

China Denies Responsiblity for Fentanyl Crisis

By Pat Anson, Editor

China is disputing claims that most of the illicit fentanyl and related chemicals that are being smuggled into the U.S. and killing thousand of Americans originated in China. President Trump has said he would ask Chinese President Xi Jinping to “hold back the flood of cheap and deadly fentanyl” when he visits Beijing this week.

Fentanyl is a synthetic opioid 50 to 100 times more potent than morphine. It is prescribed legally to treat severe pain, but illicit fentanyl and its chemical analogues have become a scourge on the black market, where they are often mixed with heroin or turned into counterfeit prescription drugs.

“The evidence isn't sufficient to say that the majority of fentanyl or other new psychoactive substances come from China," said Wei Xiaojun, deputy director-general of China’s Narcotics Control Bureau of the Ministry of Public Security.

Wei spoke at a joint news conference Friday with the U.S. Drug Enforcement Administration. China and the DEA have stepped up their cooperation on drug control problems in recent months, with Beijing putting dozens of fentanyl related chemicals on its list of controlled substances.

“Once China controls a substance it has a dramatic effect on the United States in terms of lives saved,” said Lance Ho, who heads a new DEA office in Beijing.

DEA PHOTO OF counterfeit FENTANYL PILLS

"We did this even when there is no widespread fentanyl abuse in China," Wei said. "We were aware of the crisis in the U.S. and took the U.S. concern into consideration."

But an editorial in a Korean newspaper disputed the level of Chinese cooperation, claiming that China was using fentanyl in a “chemical war” against the U.S.

“Fentanyl is the nuclear narcotic that is killing thousands of Americans today and another example of China’s two-faced approach. The chemical, known as ‘China Girl’ or ‘China White’ on the street, may have some Chinese victims, but its true value is as a profitable opiate export that also destroys American communities and roils the U.S. political landscape,” said The Korea Herald. 

“Drug exports have allowed for the establishment of new Chinese-run drug cartels and distributors within the United States while untimely and tragic American deaths are recorded daily.”

According to the CDC, illicit fentanyl killed 20,000 Americans in 2016. A recent CDC study found that over half the opioid overdoses in ten states involved fentanyl.

Son of Fox News Anchor Overdosed on Fentanyl

The son of a former Fox News anchor overdosed and died after taking counterfeit prescription drugs made with fentanyl, according to reports.

19-year old Eric Bolling Jr. was found dead in his Boulder, Colorado apartment September 3. He is the son of Eric Bolling, who was recently fired by Fox News for allegedly sending lewd texts to several women.

The Boulder County coroner recently reported the younger Bolling had high levels of fentanyl, cocaine, marijuana and the anti-anxiety drug Xanax in his system when he died.

According to police, Bolling and a friend had gone to Denver the day before his death to buy cocaine and other drugs. They bought five pills that appeared to look like Percocet, a branded version of the painkiller oxycodone. Bolling, who had a history of drug abuse, took one of the pills and quickly realized it wasn’t Percocet.

ERIC BOLLING AND SON ERIC JR.

“Eric took half of a percocet and the cocaine dealer took half of a percocet. Within a few minutes Eric and the percocet dealer started ‘panicking’ because they had a different reaction to the percocet than they normally do. Eric made the comment that he thought the percocet may have contained fentanyl,” investigators said in a police report obtained by TheBlast.com.

Bolling’s body was found by a girlfriend the next day. His death has been ruled accidental.

The DEA recently added three more fentanyl analogues -- ortho-fluorofentanyl, tetrahydrofuranyl fentanyl, and methoxyacetyl fentanyl  -- to its list of Schedule I Controlled Substances, chemicals that are considered highly dangerous and addictive.

At least 17 confirmed overdose deaths have been linked to the three drugs in Georgia, North Carolina, Texas, New Jersey, Wisconsin and Pennsylvania. The drugs have also been found in California, Florida, Ohio and Missouri.

The Justice Department recently indicted two major Chinese drug traffickers accused of manufacturing fentanyl in drug labs in China and selling it to U.S. customers over the Internet.

FDA May Require Opioids Be Packaged in ‘Blister Packs’

By Pat Anson, Editor

The Food and Drug Administration may soon require some opioid pain medications to be packaged in “blister packs” to limit the number of pills that can be prescribed and dispensed at one time.

“This is something we’ve been looking at for some time. And it is gaining some traction inside the agency as a potential solution to instigate different kinds of prescribing patterns around opioids. Something like this could move potentially quickly. We’re invested in it and taking a hard look at this,” FDA commissioner Scott Gottlieb told CNBC.

In May, Gottlieb appointed an Opioid Policy Steering Committee to study ways that the supply of opioids for short-term acute pain could be limited through packaging. Next month the FDA will hold a two-day public workshop with health experts and drug makers to discuss packaging options.

“One of the things that we can do is look at blister packs as an alternative to how opioids are dispensed. And perhaps package opioids in blister packs where it might come in a 2, 4, 6 or 8 day supply.  That would potentially encourage more doctors to prescribe smaller durations of use for patients,” said Gottlieb.

“This would be especially relevant to immediate release formulations of the drugs, which are the most widely prescribed formulations. And where most people form an addiction.”

Gottlieb said if doctors wanted to prescribe more opioids – such as a 30-day supply – the FDA could require that they “jump through additional hoops” such as a mandatory prescriber education course.

"We're at a point in this crisis that we're going to have to think of ideas and taking actions that are going to be more disruptive and are going to be uncomfortable to some parties," he said.

Several states have already adopted regulations that limit the supply of opioids for acute pain to seven days or less. CVS recently announced that its pharmacists would limit new opioid prescriptions to 7 days’ supply, starting in February for customers enrolled in its pharmacy benefit management program.

I Am a Casualty of the War on Drugs

By Lorelei Bryan, Guest Columnist

I am a 51 year old wife, mother, grandmother and businesswoman, among other things.  Along with all of those other titles and roles, I am a person who lives with chronic pain.

I do not like the label “chronic pain patient,” as it carries with it more stigma and derogatory implications than ever. 

In 2010, I began to experience extreme pain near my left ear.  Suspecting an ear infection, I went to my primary care physician. After examining me and asking a lot of questions, he said I had no infection and that he suspected this was related to the temporomandibular joint (TMJ) in my jaw. Like most people, I had heard of TMJ and thought it was the result of grinding or clenching my teeth. A visit to my dentist confirmed that there was no evidence of grinding or clenching.  He was at a loss. 

Thus began my two year journey of one oral surgeon after another, one therapy after another, and one failed surgery after another, trying to get this condition resolved. All the while, I battled between the primary care doctor and the surgeons on which of them was going to write the pain medication prescriptions I needed to keep functioning throughout this ordeal.

Finally, after two years and seven surgeries of various types, I was referred to an oral surgeon who specialized in TMJ patients with advanced and rare conditions.  A cat scan revealed that arthritis had destroyed almost all of the bone structure in my jaw.  I had to have two more major surgeries; one to remove what was left of the diseased bone and the second to install custom made titanium jaw parts.  

LORELEI BRYAN

The surgeon warned me that the procedures would restore function to my jaw (I could not open my mouth more than a few millimeters), but that I may be left with chronic pain.  He was right on both counts. The combination of the multiple surgeries, scar tissue, damage to the surrounding structure, and permanent nerve damage left me with severe chronic pain from trigeminal neuralgia that will never improve. 

During the final two surgeries, I was working with a pain management specialist who knew my surgeon.  All was well, as they communicated regularly and I was receiving pain medication that allowed me to manage my pain to the point of having a relatively normal life, although not completely pain free. 

In 2014, 18 months post replacement surgery. I received a letter from my pain management doctor explaining that he was no longer treating pain patients. No additional prescriptions would be given to any patient and no referrals to other doctors or pain clinics would be provided.  Just like that, everyone he treated for pain was dropped. Of course, I panicked, as I’m sure many of his other patients did. Being dropped by a doctor for no reason and with no support for transitioning to another provider feels like betrayal.

I sought help from my primary care provider and, fortunately, he said he could treat my pain himself. I was very relieved and grateful to him.  For three years he and I worked together to manage my chronic pain, including the trigeminal neuralgia that the surgeries caused. We were able to use a combination of Tegretol and oxycodone that reduced my need for oxycodone by 20mg per day, as compared to the dose I was on with the pain management specialist.

Never before had my pain been managed to the point it was.  He and my pharmacist know each other well, and the three of us worked together to manage my pain.   

The War on Drugs Targets the Wrong People

Fast forward to June 2017.  I go in for my every other month appointment with my primary care provider. He does his exam, we talk about my other medical issues, and then he gets a grave look on his face.  “I can’t write the oxycodone for you anymore,” he says. 

I am thrown.  He explains that the state has instituted strict limits on who can be prescribed narcotic pain medication and very strict limits on the amounts. I couldn’t breathe. Thoughts of what life would be like without having my pain effectively managed ran through my head -- reduced job performance, reduced job attendance, possible job loss, checking out of the lives of my children and grandchildren, suffering and crying all day like I used to. 

When I gained a little composure, I said, “We are talking about my quality of life here. I know why this is happening. This so called ‘war on drugs’ is creating a war on the wrong people.” 

My doctor agreed that I am a model pain management patient, a “poster child” for the appropriate use of narcotic pain medication. I see only him. I use only one pharmacy and he knows the pharmacist personally. I take the medication according to directions. I do not doctor shop. I do not ask for early refills.  I follow all the rules and still I have to suffer, so that a bunch of bureaucrats who have no right getting involved in what my healthcare provider deems appropriate for me, so they can pat each other on the back and congratulate each other for “striking a blow in the opioid crisis.”  

When I put it that way, the doctor agreed that I was a prime example of a responsible patient who needs this medication and is not a high risk. He agreed to continue writing the narcotic pain medication prescriptions, but explained that new state laws meant we had to almost cut my dose in half. 

I am now trying to manage on much less medication. The increased pain level makes it difficult to concentrate at work. It has made me withdraw from my husband. And it has impacted my ability to be the mother and grandmother I should be.

These bureaucrats and politicians are causing needless suffering for thousands of people in pain, while doing virtually nothing to stem the heroin overdoses that are the prevailing reason for the opioid crisis in the first place.

Is there a serious issue with abuse and addiction to narcotic pain medication?  Of course there is, and something should absolutely be done to address it.  But taking away medication needed by people in chronic pain is not the answer.  Limiting or denying medication to legitimate patients who need it to live and function with any quality of life only creates another crisis. More and more people turn to illegal drugs or, worse yet, commit suicide because their medication has been taken from them and they cannot endure without it.

My question is this: where is our voice?  For all of the politicians and celebrities speaking out on the war on drugs, who is speaking out on the other side of this?  If someone of consequence and influence does not speak out for people in pain, these new laws and limits will create just another silent epidemic and the war on drugs will take more lives than ever.

Lorelei Bryan lives in Virginia.

The Virginia Board of Medicine recently adopted emergency regulations that require doctors who prescribe more than 120mg morphine equivalent (MME/day) to a patient to document the justification for the dose or to refer or consult with a pain management specialist. It does not expressly forbid doctors from prescribing more than 120 MME/day.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

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