DEA Warns About Fentanyl As It Draws Criticism for Crackdown on Doctors

By Pat Anson, PNN Editor

The Drug Enforcement Administration has issued another public warning about the growing risk of counterfeit opioids and other medications made with illicit fentanyl. Over two-thirds of the drug deaths in the U.S. involve synthetic opioids like fentanyl, which is 50 to 100 times more potent that morphine.

Last year the DEA seized over 50 million counterfeit pills laced with fentanyl and more than 10,000 pounds of fentanyl powder. The seizures represent more than 379 million potentially deadly doses of fentanyl, according to the DEA, enough to kill every man, woman and child in the United States.

Over 56,000 American deaths last year involved fentanyl, nearly the number that died in the Vietnam War, and the crisis appears to be escalating. In 2021, a DEA laboratory analysis estimated that 4 out of 10 counterfeit pills laced with fentanyl contained a potentially lethal dose. The DEA now estimates that six out of ten fake pills contain a deadly dose of fentanyl. Just two milligrams of fentanyl, enough to fit on the tip of a pencil, is considered a potentially lethal dose.

“More than half of the fentanyl-laced fake prescription pills being trafficked in communities across the country now contain a potentially deadly dose of fentanyl. This marks a dramatic increase – from four out of ten to six out of ten – in the number of pills that can kill,” DEA Administrator Anne Milgram said in a public safety alert. “Never take a pill that wasn’t prescribed directly to you. Never take a pill from a friend. Never take a pill bought on social media. Just one pill is dangerous and one pill can kill.”

In an effort to bring more public attention to the fentanyl crisis, the DEA launched its One Pill Can Kill campaign, which highlights the similarities between real medications like oxycodone and alprazolam and their fake counterparts. The counterfeit pills are mass produced by drug traffickers in the U.S. and Mexico, using chemicals largely sourced from China.

Backlash Against DEA

As the DEA grapples with the fentanyl crisis, it’s coming under growing criticism about its efforts to reduce the supply of legal prescription opioids. Recent articles in USA Today, The New York Times, Los Angeles Times and VICE News – many based on stories that first appeared on PNN – suggest that the mainstream media is slowly coming to recognize the harm caused to pain patients by the DEA’s enforcement actions against doctors who prescribe opioids.

“Law enforcement agencies, especially the Drug Enforcement Administration, are out of control, with the DEA routinely caught releasing ‘safety plans’ for the patients of arrested physicians that simply direct pain patients to the nearest emergency room,” wrote Peter Pischke, a disabled freelance journalist, in a USA Today op/ed.

“American medicine and law enforcement continue to fight the last war. Policymakers still operate under the assumption that too many opioids are being prescribed. Overdose deaths — including those among adolescents — are now overwhelmingly caused by street fentanyl, not prescription medications,” Maia Szalavitz wrote in The New York Times.

The backlash against the DEA produced a backlash of its own in Newsweek, in an op/ed by a former deputy chief of staff at the DEA. Rather than doing fewer enforcement actions against doctors, Jim Crotty believes there should be more.

“With the U.S. drug crisis reaching unprecedented levels, and many opioid use disorders starting with prescription drugs, now is not the time to increase their availability,” wrote Crotty, who said the recent deaths of patients who lost access to opioids when their doctor’s license was suspended do not justify a change in DEA policy.

“These isolated incidents, however tragic, should not be used to upend otherwise sound drug policies designed to protect the American public from drug addiction and abuse,” said Crotty. “The U.S. is making slow but steady progress in rolling back the opioid crisis, but there is much work to be done. The threat of prescription opioids still looms large and requires continued vigilance from DEA and its partners to protect Americans' health and safety. We should be asking them to do more, not less.”

Crotty said over 13,000 Americans have died from overdoses involving prescription opioids in the last 12 months – a fraction of the number dying from fentanyl -- and repeated the old saw about the U.S. being “the world's largest consumer of prescription opioids.” That may have been true a decade ago, but no longer is. The U.S. now ranks 8th in per capita opioid consumption, behind Canada, Australia and several European countries

Letters to Doctors Reduced Their Opioid Prescribing for a Year

By Pat Anson, PNN Editor

Many doctors in the U.S. have scaled back or stopped prescribing opioid pain medication because they fear scrutiny or even imprisonment by the DEA and other law enforcement agencies.

A team of USC researchers believes there’s a better way to address risky opioid prescribing: have coroners and medical examiners notify all doctors by letter when a patient dies from an overdose.  

“This is not meant to be a law enforcement exercise but a simple nudge. The point is not to scare, blame or shame doctors, but to make them aware of real risks in their patient cohorts, risks they may not be aware of otherwise,” says Jason Doctor, PhD, Professor and Chair of Health Policy and Management at USC’s Sol Price School of Public Policy.

Doctor and his colleagues found that when 809 prescribers received a letter from San Diego county’s medical examiner notifying them about the overdose death of a patient, they reduced the doses of opioid prescriptions they wrote for up to a year afterward. Their findings, published in JAMA Network Open, builds upon a previous study that found the same clinicians reduced their prescribing for three months after receiving such a letter.

"Clinicians don't necessarily know a patient they prescribed opioids to has suffered a fatal overdose," said Doctor. “We knew closing this information loop immediately reduced opioid prescriptions. Our latest study shows that change in prescribing behavior seems to stick."

Nationwide, opioid prescribing has fallen dramatically over the past decade. But USC researchers found the reduction was faster and more extensive among clinicians who received the letter. After one year, their prescriptions were 7.1% lower in morphine milligram equivalent units (MME) than clinicians who hadn't received the letter. The number of new patients they prescribed opioids to also fell by two percent.

"The new study shows this change is not just a temporary blip and then clinicians went back to their previous prescribing," said Doctor. "This low-cost intervention has a long-lasting impact."

Other Drugs Often Involved

There are three major caveats to the USC study. The first is that other substances besides prescription opioids – such as illicit drugs -- were involved in many of the overdose deaths. That’s because the criteria for the study were broad and subjective, including any patient who died when "prescription drug overdose was the primary cause or contributed to the cause of death."

Second, clinicians were included in the study if they had written any opioid prescription within 12 months of the patient’s death. That would explain why 809 prescribers received letters about the overdoses of 166 patients. Doctors received a letter even if a patient was no longer under their care and without conclusive evidence that the prescription they wrote was involved in the death.

Third, the study does not address the growing number of deaths caused by illicit fentanyl, which is now responsible for the vast majority of U.S. overdoses. Letters to doctors are unlikely to have any major effect on overdoses involving street drugs. A 2022 study confirmed there is very little correlation between overdoses, prescription opioids and MME dosage levels.

There have been several previous efforts to rein in opioid prescribing by sending warning letters to doctors. Federal prosecutors in Wisconsin and other states have done it, telling high-dose prescribers they could face prosecution, even when they have not been charged with a crime or linked to an overdose.

The Medical Board of California’s “Death Certificate Project” sent threatening letters to doctors about overdoses that occurred months or years after an opioid prescription was written -- an effort that some likened to a “witch hunt.” Some doctors were targeted even when multiple drugs were involved or the cause of death was suicide.

USC’s Doctor says a gentler “nudge” is needed, not threats. And he wishes the letters sent to San Diego doctors were mandatory statewide.

“That was a terrible approach to delivering letters that the medical board carried out,” Doctor wrote in an email. “We had none of the outcry or problems the (board) did because we were supportive and met clinicians on a professional level.”

A Third of Chronic Pain Sufferers Used Cannabis for Pain Relief

By Pat Anson, PNN Editor

Nearly a third of U.S. adults (31%) with chronic pain have used cannabis as an analgesic, according to a new survey that found over half of those who used cannabis said it enabled them to decrease their use of opioid medication and other pain therapies.

The survey findings, published JAMA Network Open, involved 1,724 people with chronic non-cancer pain who live in the 36 states (and Washington DC) that have legalized medical marijuana.

Unlike other studies that only focused on cannabis reducing opioid use, this survey found that over half of pain sufferers using cannabis also reduced or stop using non-opioid prescription pain relievers and over-the-counter analgesics. Many respondents also reported decreasing their use of physical therapy (39%), cognitive behavioral therapy (26%) and meditation (19%).  

“Most persons who used cannabis as a treatment for chronic pain reported substituting cannabis in place of other pain medications including prescription opioids,” wrote lead author Mark Bicket, MD, an Assistant Professor in the Department of Anesthesiology, University of Michigan School of Medicine.

“The high degree of substitution of cannabis with both opioid and nonopioid treatment emphasizes the importance of research to clarify the effectiveness and potential adverse consequences of cannabis for chronic pain. Our results suggest that state cannabis laws have enabled access to cannabis as an analgesic treatment despite knowledge gaps in use as a medical treatment for pain.”

The survey did not ask whether respondents smoked, vaped or ingested cannabis products, so there’s no way to tell which method was more effective at reducing pain. Nevertheless, it adds to a growing body of evidence that cannabis reduces pain and helps pain sufferers decrease their use of medications and other therapies.  

“Cannabis has established efficacy in the treatment of multiple conditions, including chronic pain, and it possesses a safety profile that is either comparable or superior to other controlled substances,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group.

“So it is no wonder that those with legal access to it are substituting cannabis in lieu of other, potentially less effective and more harmful substances. As legal access continues to expand, one would expect the cannabis substitution effect to grow even more pronounced in the future.”

Several previous studies have also found that cannabis users often reduce their use of prescription opioids. A large survey conducted last year found that most medical marijuana users either stopped (42%) or reduced (37%) their use of opioids. A small number were also able to stop using psychiatric medications for anxiety, depression and PTSD.  

Another recent study at Cornell University found that legalization of recreational marijuana in 11 states led to significantly reduced prescribing for Medicaid patients for a broad range of medications used to treat pain, depression, anxiety, seizures and other health conditions.

A 2021 Harris Poll found that twice as many Americans are using cannabis or CBD to manage their pain than opioids.

Judge Won’t Stop DEA Despite Patient Deaths

By Pat Anson, PNN Editor

A federal judge in California has refused to grant a temporary restraining order that would have allowed Dr. David Bockoff to resume prescribing opioid medication to hundreds of pain patients at his practice in Beverly Hills. 

The Drug Enforcement Administration suspended Bockoff’s license to prescribe controlled substances on November 1, claiming five of his patients were in “imminent danger” because he prescribed high doses of opioids and kept inadequate medical records. Since the DEA’s suspension, however, at least two of Bockoff’s patients have died -- not because of his medical care, but from the lack of it.

Danny Elliott and his wife were so distraught over his inability to find another doctor and get opioid treatment that they both committed suicide on November 7.  Four weeks later, Jessica Fujimaki died at her home, apparently from complications caused by pain and opioid withdrawal. Both Elliott and Fujimaki had incurable conditions that cause severe pain and needed high dose opioids to have any quality of life.

Despite those deaths and the threat posed to other sick patients who can’t find new providers, Judge Stanley Blumenfeld, Jr. sided with the DEA, saying the “potential impact” on Bockoff’s patients was outweighed by the DEA’s concerns about his record keeping.

“The need for careful evaluation, monitoring, and control in these circumstances is obvious; and the combination of high dosages and the lack of documentation justifying those dosages and demonstrating proper evaluation and oversight is troubling,” Blumenfeld wrote in his 7-page ruling.

“As for the public interest, the Court is certainly concerned about the potential impact on vulnerable patients who need treatment to manage their pain. This concern, however, must be evaluated in the context of a case in which the DEA is asserting abusive prescription practices and its decision is entitled to deferential review.”

Bockoff has practiced medicine for over 50 years in California without any prior record of disciplinary action or complaints. The DEA provided no evidence that any of Bockoff’s patients – including the five said to be in “imminent danger” – were harmed while under his care.

One of the five – who is only identified in court records as “EC” – has lived with severe pancreatic pain for over 15 years. Bockoff gave her prescriptions for methadone and fentanyl, a potent synthetic opioid. In its emergency suspension order, the DEA said that use of fentanyl was “not consistent with FDA approved use,” and put EC at higher risk for addiction, overdose and death.

However, in an email provided to the judge, EC said she needed high doses of fentanyl to be able to work and eat food.

“I have exacerbated pain anytime I smell food, eat food, digest food, or sometimes just randomly,” EC wrote. “This pain medication allows me to practice law and serve as a prominent traumatic brain injury litigator and managing attorney for the largest personal injury law firm in California.

“I am able to rise to this level of practice because Dr. Bockoff counsels me on how to manage my pain and prescribes medication for me that allows me to manage my pain so I can be a contributing member of society.”

Judge Blumenfeld dismissed the email, essentially saying that EC’s medical records were more important than her ability to eat and work.

“While proper pain management can have significant benefits, E.C’s email does not fully address the allegations that she was prescribed controlled substances without proper medical evaluation, monitoring, and documentation,” the judge wrote.

‘More Deaths Could Be Imminent’

Several other patients – whose full names were redacted -- also provided testimonials about their care under Bockoff.

“I want to say I appreciate Dr. David Bockoff as the rarest of physicians that actually cares about my health and well-being,” MC wrote in a letter. “If I no longer could receive my pain medication from Dr. Bockoff I would not be able to walk, do house chores, continue part time consulting work, go to school, drive, not be able to get out of bed or walk even in the house.”

“I suffer from a great deal of pain and without medication my life would be awful. I would not be able to move, stand or do any of the activities that I do perform,” said SH. “Dr. Bockoff has helped me tremendously and I need his service in order to have some quality of life.”

“Dr. Bockoff’s practice is already filled with patients who are in a dangerous medical predicament, with no medicine. As more patients run out of their last month’s medication, more deaths could be imminent,” warned DL.

Judge Blumenfeld rejected those claims as well, saying Bockoff’s attorney, Ashli Summer McKeivier, provided no evidence that Bockoff’s medical practice faced “irreparable harm” from to his suspension or that the DEA erred in suspending his license.  

“Plaintiff has not responded by producing substantial evidence to refute claims that he has been improperly dispensing high dosages of the controlled substances at issue,” Blumenfeld wrote. “Nor has Plaintiff shown that there are no other available providers able to properly treat patients who can no longer receive a prescription from him.”

“I’m very disappointed in the judge’s ruling,” McKeivier told PNN.

Munzing Testimony

Much of the government’s case against Bockoff is dependent on the opinions of Dr. Timothy Munzing, a family practice physician who has created a lucrative second career for himself by working as a consultant for the DEA and DOJ. According to GovTribe, a website that tracks federal contracts, Munzing has made over $3.4 million in the last 8 years working for the government and testifying in dozens of cases against doctors.

“Dr. Munzing will testify that Dr. Bockoff’s patient care fell below the standard of care in California and the prescriptions resulting from several examinations were not for a legitimate medical purpose,” the DEA said in court documents. Munzing was not called to testify before Judge Blumenfeld.

McKeivier says the DEA failed to prove there was any “imminent danger” or harm done to Bockoff’s patients, even though Munzing reviewed three years of his medical records.

“The government made an argument that basically disproved itself,” she said. “If you’ve got 3 years of records and in those 3 years of records you cannot point to one example of death, overdose, bodily injury or diversion, then that disproves the fact that any of the danger based on those things is imminent. If for three years you have a track record of it never happening, then how can it be imminent to happen now?”  

Bockoff is pursuing another legal avenue by appealing his suspension to a DEA Administrative Law Judge, who will begin hearings in Washington DC on January 19. That hearing process is expected to take nine days. A final decision on the suspension could be weeks or months after that.

Guideline Recommends Surgery Patients Be Screened for Cannabis Use

By Pat Anson, PNN Editor

New medical guidelines recommend that all patients undergoing anesthesia should be screened for cannabis use before surgery, and that procedures should be delayed if patients are thought to be under the influence or impaired.

The guideline by the American Society of Regional Anesthesia and Pain Medicine (ASRA Pain Medicine) is intended for anesthesiologists. It was developed by a panel of experts that included anesthesiologists, pain specialists and a patient advocate to deal with the growing number of people using either recreational or medical marijuana. An estimated 10% of Americans use cannabis monthly.

“Before surgery, anesthesiologists should ask patients if they use cannabis – whether medicinally or recreationally – and be prepared to possibly change the anesthesia plan or delay the procedure in certain situations,” Samer Narouze, MD, ASRA Pain Medicine president, said in a statement.

“They also need to counsel patients about the possible risks and effects of cannabis. For example, even though some people use cannabis therapeutically to help relieve pain, studies have shown regular users may have more pain and nausea after surgery, not less, and may need more medications, including opioids, to manage the discomfort. We hope the guidelines will serve as roadmap to help better care for patients who use cannabis and need surgery.”

The guideline recommends that patients be asked about their cannabis use before surgery, including whether it was smoked or ingested, the amount used, how recently it was used, and the frequency of use. It does not endorse drug testing of patients, meaning patients would have to be taken at their word.

If a patient admits recently smoking cannabis, the guideline recommends that non-emergency, elective procedures be postponed for a minimum of two hours because of the increased risk of a heart attack before, during and after surgery.

“In my opinion, these guidelines appear to be overly cautious at best and discriminatory at worst,” said Paul Armentano, Deputy Director of NORML, a marijuana advocacy group. “The relationship between cannabis and opioids is well-established, with nearly 100 papers in the literature showing that pain patients typically reduce or eliminate their intake of opioids over time following cannabis use.” 

Armentano cited a recent pilot study that found people who use cannabis respond no differently to local anesthesia than those who do not. Local anesthesia is different from general anesthesia because patients remain conscious during a procedure such as dental work. 

The evidence on cannabis and general anesthesia is rather thin, and because of that the ASRA guideline gives low grades to several of its recommendations, including the one about delaying surgery.  No recommendations are made about tapering cannabis use before or after surgery, or whether to prescribe opioids to patients who use cannabinoids due to “current lack of evidence.” Anesthesiologists are instead urged to use their own clinical judgement.   

In 2020, the Perioperative Pain and Addiction Interdisciplinary Network (PAIN) released more restrictive guidelines about cannabis use, recommending that heavy cannabis use be tapered or stopped before surgery.

Charges Against Founder of Genetic Testing Company Dropped

By Pat Anson, PNN Editor

The U.S. Department of Justice has quietly dropped criminal charges against the founder and CEO of Proove Biosciences, a genetic testing company based in California that was accused of paying physicians over $3.5 million in illegal kickbacks. A judge dismissed the case against Brian Meshkin and five other defendants last month “in the interests of justice” after federal prosecutors declined to move forward with the case.

“There has been so much injustice over the past 6 years that it is wonderful to see truth prevail.  I am excited to have the opportunity to set the record straight and to move forward from here with my head held high,” Meshkin said in a statement.

A spokesperson for the U.S. Attorney’s Office in San Diego declined to comment on the case being dismissed, according to The Orange County Register.

Proove specialized in genetic testing of pain patients and claimed its DNA tests could determine how well they metabolized opioid medication and if they were at risk of abuse. The company claimed that 94% of patients experienced significant pain relief within 60 days of treatment changes based on their test results.

Proove’s aggressive marketing included millions of dollars in “research fees” paid to physicians who ordered its tests, a practice that ran afoul of federal kickback laws. In 2017, the company’s headquarters in Irvine, CA was raided by FBI agents and Proove was placed into a court-ordered receivership – a form of bankruptcy – when its business collapsed.

The former vice-president of marketing for Proove plead guilty in 2020 to paying illegal kickbacks. The following year, the National Spine & Pain Center in Maryland agreed to pay $5.1 million in restitution to Medicare as part of a criminal settlement for taking kickbacks from Proove.

Meshkin blamed the company's legal and financial problems on “erroneous and damaging” reports by STAT News, which detailed how physicians could make up to $144,000 a year if they funneled their patients’ genetic tests to Proove.

“This work was destroyed by misinformation spread by a handful of disgruntled ex-employees and contractors, spread by the media, and blindly adopted by some in the Southern District of California office of the U.S. Attorney and the FBI,” Meshkin said. 

“That misinformation and false and defamatory allegations directed at Proove hurt thousands of people beyond the company itself, including the many patients and their families who have died from or whose lives were impacted by opioid overdoses and suicide that could have been prevented with access to Proove’s life-saving technology.”

Many questions remain about the effectiveness of the tests. A genetic expert told STAT News the company’s testing claims were “hogwash” and said they exploited fears about opioid addiction.  A Montana pain patient who took the test and followed Proove’s treatment advice said they didn’t work for her.

“To me it was a waste of time and money. The meds it said I should be taking either didn’t work, stopped working, or made me sick. And the meds I should not be taking, I do just fine on,” she told PNN in 2017.

Gabapentin Won’t Cure the Opioid Crisis

By Pat Anson, PNN Editor

The risk of prescribing gabapentin (Neurontin) off-label for pain management may finally be sinking into the medical community. The latest sign is an op/ed published in JAMA Internal Medicine, which warns that gabapentin is often ineffective for pain, may raise the risk of overdose, and “will not cure the opioid crisis”    

Gabapentin is a non-opioid medication that was originally developed as an anticonvulsant to treat epileptic seizures. In recent years, gabapentin prescribing has grown 5-fold, with a growing number of physicians prescribing it “off-label” for both acute and chronic pain. Some do it as an alternative to opioids, while others prescribe it in conjunction with opioids.

“Gabapentin is often thought of as a safe alternative for pain management and may be initially enticing as a nonopioid medication, though the evidence for its efficacy in pain control is limited,” wrote lead author Raegan Durant, MD, a Professor at University of Alabama at Birmingham School of Medicine and Associate Editor at JAMA.

“With more restrictive opioid prescribing guidelines, physicians may be struggling to treat pain effectively and more frequently turning to gabapentin as a nonopioid option. However, avoidance of opioids at the expense of either more frequent use of gabapentin or concurrent gabapentin and opioids simply exposes patients to similar risks for harm often without improving the likelihood of actual pain relief.”

The warning from Durant and JAMA Associate Editor Audrey Han, MD, stems from a recent study about the “alarming upward trajectory” of gabapentin being co-prescribed with opioids.  From 2006 to 2018, overlapping prescriptions for the two medications rose by 344 percent, with many of the prescriptions being written by pain specialists.

Gabapentin is only approved by the Food and Drug Administration to treat partial seizures, nerve pain from shingles and restless leg syndrome, but is also widely prescribed off-label for fibromyalgia, neuropathy, migraine and other pain conditions – despite little evidence supporting its use.  

In addition to poor pain relief, many patients who take gabapentin report side effects such as dizziness, confusion, drowsiness, mood swings and weight gain. A 2019 study linked gabapentin to a growing number of attempted suicides.

Gabapentin may cause euphoria, feelings of intoxication, and enhance the effects of opioids and other drugs. The FDA has warned that gabapentin may cause serious breathing problems and respiratory depression, especially in older adults. A recent study found gabapentin raises the risk of delirium in seniors recovering from surgery.

My Story: How Opioid Therapy Saved Me and My Family

By Kim Halvorson, Guest Columnist 

I have had reoccurring pain episodes since I was 16 years old.  The one and only doctor we had on the Flathead reservation in Montana created even more problems for me than he solved. First, he offered me opioids (it was the 70’s) and wanted to inject the knots in my body with cortisone, without any diagnoses. My mother and I decided against his advice and began nutrition, exercise and therapy -- both mental and physical.  

When I was almost 30, the same doctor offered me a "new miracle med" that would block the pain signals in my brain. He prescribed the antidepressant amitriptyline, and I had my one and only manic episode. If he had taken any time to recognize my hyper self, maybe he would not have given me an antidepressant without any warnings about its side effects.  The strongest medicine I had ever taken, at that point in my life, was Tylenol.    

It took me a few years to recover from that total breakdown. Waking up in a psych ward is more than a little scary.  But the psychiatrist there listened to me and tried many different medications, until we landed on Klonipin and Trazodone to help me sleep. That was my answer for almost 30 years.

When my two sons were active toddlers, the pain bouts became too much.  My first opioid, at age 40, came with common sense and compassion from a wise and caring doctor. She could not find the underlying cause of my pain, but knew I was telling the truth. After all, I had said no to opioids for 25 years.   

She would write only 3 opioid scripts a year. If I needed more, then we’d have to find out what was going on inside my body. That worked for 10 years. And it taught me discipline.     

KIM HALVERSON

At age 50, I broke my back in 3 places and required daily opioids to move at all.  The doctor linked my meds to better physical function, and I was on that dose for 5 years without an increase. Opioids helped me to hold onto our house and attend my sons' games --- both of them are athletes.    

Then came the "big scare" as I call it.  When Florida lost its mind and went after the pill mills. The country over-reacted to the opioid crisis and in many places still is. The truth about Florida became a fiction about Montana and everywhere else, it seems. The pain clinic that had saved my little family for 5 years got rid of me and many other patients to protect their practice.        

For the next 4 years, a local clinic and a brave nurse practitioner bucked the system and got me half of what I needed.  It was better than nothing and I “saved up” pills by staying in bed until a game was on or some work had to be done.  Those 4 years were hard on me, and I ended up in a wheelchair and incontinent. 

I kept looking for a reasonable doctor and eventually found one. Once I was put back on the dose that worked for those 5 years, it only took a few months to regain my strength enough to face surgery and get a new artificial hip.      

The new hip was supposed to reduce my pain, but my pain level doubled. A new doctor found out why. I had scoliosis, and the surgery that was supposed to help me had locked me into pain 24/7. The first year after the new hip, a lump formed in my back and my body felt the pain I had been trying to avoid all my life.      

I know what is causing my pain now and why certain injuries were far worse than I thought they would be. That hip that looked “blown up” on an x-ray was the fulcrum of my frame, a curve in my spine and I have been wrestling with since I was 16.      

Even knowing all of this, my pain doctor felt pressured to stop helping people like me or anyone with opioids. I was abandoned, but found another doctor who just recently stopped calling himself a “pain management specialist” because of what is still happening to other doctors.    

I am already looking for the next reasonable doctor, just in case, but it is not supposed to be this way.  We shouldn’t have to fight this hard to live any kind of life.    

All of us need to join the fight. We need to start with ourselves and our support team, and then we must find allies within the medical profession and help them help us.  I will protect my three doctors completely.  I never do anything that could be misconstrued by anyone and often supply them with information to protect themselves, just in case.    

And then we all need to share our story.  Help each other with those stories.  Become our own best experts and advocates.   

Kim Halvorson lives outside Missoula, Montana.  

Do you have a “My Story” to share? Pain News Network invites other readers to share their experiences about living with pain and treating it. Send your stories to editor@painnewsnetwork.org.

Gabapentin and Pregabalin Only ‘Modestly Effective’ for Pain

By Pat Anson, PNN Editor

A new review of clinical studies on the use of gabapentin (Neurontin) and pregabalin (Lyrica) in pain management found the drugs are only “modestly effective” and could be risky for some pain patients.

Gabapentin and pregabalin belong to a class of nerve medication called gabapentinoids, which were originally developed as anticonvulsants to treat epileptic seizures. In recent years, however, they have been increasingly prescribed off-label as an alternative to opioids in managing pain. About one in five U.S. adults with chronic pain are prescribed a gabapentinoid.  

"Treating pain has been problematic for a long time, and we're still dealing with the fallout from opioid overuse," says lead author Craig Williams, PharmD, a clinical professor at Oregon State University College of Pharmacy. "Gabapentinoids are modestly effective for certain patients; they are rarely extremely effective, and they are not effective at all for some patients because the mechanisms of the pain don't match up with the mechanisms of the drug.

"Doctors who prescribe gabapentinoids for pain should do so with their eyes wide open and be prepared to stop them if they are ineffective or cause too many side effects."

The study findings, published in the journal Drugs, found that many of the clinical trials for gabapentin and pregabalin were of short duration, had a small number of participants, and performed only slightly better than placebos in reducing pain. Many patients who take the medications also report side effects such as dizziness, confusion, drowsiness, mood swings and weight gain.

"Treating pain is about making patients more functional so they can live their lives better, and if they have to deal with adverse effects for a little pain relief, their lives may not be improving," said Williams.

Pregabalin has been approved by the Food and Drug Administration for four pain conditions: post-herpetic neuralgia (shingles), diabetic peripheral neuropathy, spinal cord injury, and fibromyalgia. Gabapentin has only been approved by the FDA for post-herpetic neuralgia.

Despite the limits on their uses, many doctors legally prescribe the drugs “off-label” for pain conditions such as migraines, back pain, post-operative pain and even dental pain. Gabapentin was once derisively referred to as “snake oil” by a pharmaceutical executive because it is so widely prescribed for so many different pain conditions, despite weak evidence.

"In addition, we found that the trials used by the FDA to approve gabepentinoids for pain indications had a couple of key structural weaknesses," Williams said. "The trials tended to be short, typically lasting one to three months, and the trials typically excluded the simultaneous use of other medications that affect the central nervous system. That's important because patients taking gabepentinoids are rarely taking them exclusively; they're often prescribed in conjunction with opioids, muscle relaxants or other epilepsy drugs."

Gabapentin can cause euphoria and feelings of intoxication, and make the effect of opioids and other drugs seem stronger. A 2019 study linked gabapentin to a growing number of attempted suicides.

That same year, the FDA warned that gabapentin and pregabalin may cause serious breathing problems and respiratory depression, especially in older adults. A recent study found that gabapentin raises the risk of delirium in older adults recovering from surgery.

Fentanyl Linked to 94% of Overdose Deaths in Massachusetts

By Pat Anson, PNN Editor

There’s good and bad news in the latest report on overdose deaths in Massachusetts. State health officials say drug deaths were down slightly in the first nine months of 2022, compared to the same period last year. But deaths involving fentanyl – most likely illicit fentanyl -- rose to 94% of opioid-related overdoses, a record high.

Massachusetts was one of the first states in the U.S. to expand the use of toxicology tests to look for the presence of certain drugs involved in opioid overdoses, instead of just relying on death certificates and coroner reports. That makes its overdose data more accurate.

In the first nine months of 2022, there were 1,340 confirmed opioid-related overdose deaths in Massachusetts, and officials expect that to reach about 1,696 deaths by the end of the year. That’s 25 fewer deaths than in 2021, a decrease of 1.5 percent.

Nationally, drug overdose deaths also appear to be slowing. The CDC estimates there were 107,735 U.S. overdose deaths in the 12-month period ending in July 2022, down from over 110,000 deaths in the 12-month period that ended in March, 2022. Illicit fentanyl, a synthetic opioid about 50 to 100 times more potent than morphine, is involved in the vast majority of those deaths.

Deaths in Massachusetts involving a fentanyl have been rising for over a decade, from nearly 42% of opioid-related overdoses in 2014 to 94% this year. Over that same period, deaths involving prescription opioids such as oxycodone and hydrocodone have steadily declined from about 35% to 11% of overdoses in 2022.

More people are now dying in Massachusetts after ingesting fentanyl, cocaine, alcohol or benzodiazepines such as Xanax than from pain medication. Deaths linked to opioid medication fell by 30% in just one year, which coincides with a steep decline in prescriptions in Massachusetts over the past decade.   

Drugs Involved in Massachusetts Opioid-Related Overdose Deaths

Massachusetts Department of Public Health

“Every life lost to opioid overdose is its own tragedy,” Public Health Commissioner Margret Cooke said in a statement. “With this report, we are encouraged by the decrease, however modest, in opioid-related overdose deaths in Massachusetts so far this year. We will continue to build on our data-driven and equity-based public health approach as we address the impacts of the opioid epidemic and the COVID-19 pandemic, especially among vulnerable populations.”

Health officials say the illicit drug supply in Massachusetts is “heavily contaminated” with illicit fentanyl, which is frequently used in the manufacture of counterfeit medication sold on the street.

Pharmaceutical fentanyl is used as a surgical analgesic and in patches and lozenges to treat severe pain, but only small amounts are diverted for abuse. The DEA estimates that only 0.01% of prescription fentanyl is diverted for use by someone it was not intended for.

It's important to note that the presence of a drug found in a toxicology screen doesn’t mean it was the cause of someone’s death. Multiples substances are frequently involved in opioid overdoses, and the official cause of death is a clinical decision made by coroners and medical examiners.

Toxicology tests alone also don’t reveal if a prescribed drug was intended for the decedent, or if it was bought, stolen or borrowed by them. An earlier study of drug deaths in Massachusetts found that only 1.3% of overdose victims had a prescription for the opioid medication involved in their deaths.

The vast majority of patients prescribed opioids use them responsibly and don’t go doctor shopping. The Massachusetts Department of Public Health estimates that only 0.6% of patients who were prescribed an opioid this year had an “activity of concern,” such as getting prescriptions from multiple providers or having them filled at multiple pharmacies.

Second Patient Dies After DEA’s Suspension of Doctor’s License

By Pat Anson, PNN Editor

A second chronic pain patient has died as a result of the DEA’s suspension of a California doctor’s license to prescribe opioids and other controlled substances. 42-year Jessica Fujimaki died Saturday, December 10th at her home in Arizona, apparently due to complications caused by opioid withdrawal.

Jessica lived with Ehlers-Danlos Syndrome (EDS), arachnoiditis, stenosis and other chronic conditions that cause severe, intractable pain and left her bedridden. In the past year, she found relief through injections of the opioid hydromorphone every two hours, which allowed her to walk, have some quality of life, and take care of her husband and two children.   

That came crashing to an end in early November, when she learned from her pain specialist, Dr. David Bockoff, that his license to prescribe opioids and other controlled substances had been suspended by the Drug Enforcement Administration.

“She was frightened, because she knew what was going to happen to her if she didn’t have that medication,” said Tad Fujimaki. “There’s no way she could live without it.”

The Fujimakis were unable to find another doctor in Arizona willing to treat Jessica, and her health steadily deteriorated as opioid withdrawal set in. In desperation, they made two trips to Mexico to purchase oral opioids there, but were uncertain of the quality of medications they received.

JESSICA FUJIMAKI

A last-minute prescription for injectable hydromorphone from an out-of-state doctor failed to stop her cascading health problems. Her exact cause of death has yet to be determined, pending an autopsy.

Had the treatment that Jessica received from Dr. Bockoff continued, Tad believes his wife would still be alive today. He blames the DEA for her death.   

“Absolutely. DEA, government, all of them. If they didn’t stop the medication, if Jessica was still getting medication from Dr. Bockoff, this would have never happened,” he told PNN.

Like many patients with EDS, Jessica wasn’t diagnosed with the genetic connective tissue disease until well into adulthood. In 2020, when the Fujimakis lived in Hawaii, she had an epidural steroid injection for leg pain that made her condition far worse. Seeking better treatment, the family moved to the mainland.

“The one mistake we made was to move to Arizona,” said Tad, explaining they could find no doctors to treat Jessica near their Phoenix home.  

“Because she was too complicated a patient. They knew they can’t prescribe hydromorphone,” he said. “If we knew the state of Arizona was an anti-opioid state, then we probably wouldn’t have moved from Hawaii to Arizona. We’d have picked a different state.”

Like many other “opioid refugees” on high doses, Jessica searched for doctors out-of-state, eventually finding Bockoff, who has practiced medicine for over 50 years in California without any record of disciplinary action or complaints.

“I have no comment. A very unfortunate tragedy,” Bockoff replied in an email when asked about Jessica’s death.  

THE FUJIMAKI FAMILY

Another Bockoff patient who lived with intractable pain ran out of medication and died one week after the license suspension. Danny Elliott and his wife Gretchen were so distraught over his inability to find another doctor and get opioid treatment that they committed suicide in their Georgia home.

‘Imminent Danger to Public Health’

Why the DEA suspended Bockoff’s license is still not entirely clear. DEA agents searched his office in September, 2021 and confiscated the medical records of 240 patients, which they later returned.

Although a DEA notice of the suspension – signed by DEA administrator Anne Milgram -- states that Bockoff posed “an imminent danger to the public health,” his license was not suspended until 14 months after the initial search, when he was accused of violating the Controlled Substances Act when treating five patients.

Those allegations primarily deal with improper record-keeping and prescribing high doses of opioids that could potentially be diverted or abused. But there is no indication that any harm was caused to the five patients while under Dr. Bockoff’s care, or that they sold or abused the opioids he prescribed.

While Bockoff appeals his suspension, 11 of his patients have hired a lawyer and tried – unsuccessfully so far -- to sign on as intervenors, so they could participate in DEA hearings on the case. One of them was Jessica Fujimaki.

“With the suspension of Dr. Bockoffs license, I am left without care again. It took over a year to find the protocol that work for me and allowed me to have some quality of life,” Jessica wrote in a statement to the DEA.

“I was very fortunate to find Dr. David Bockoff, who accepted me as his patient and has been able to treat me in accordance with the treatment protocol that works for me. This treatment protocol changed my life and gave me hope,” she wrote. “I am able to walk most days unless I am in a huge flare. Without Dr. Bockoff's care and prescribed medication, I would be bedbound, unable to walk, unable to function, and certainly unable to care for my children.”

A DEA Administrative Law Judge declined to let Jessica and the other patients participate in a pretrial conference on November 28, but has not officially rejected or approved their motion to intervene in future hearings. The patients are considering other legal avenues.

Whatever happens, it’s not likely to happen in time to prevent future tragedies. Under DEA rules, doctors have 30 days to appeal their license suspensions. Legal experts say the process can then take months or years to resolve – too long for patients like Jessica and Danny Elliott, who suffered needlessly and didn’t have time to wait.

DEA Finalizes Cuts in 2023 Opioid Supply

By Pat Anson, PNN Editor

The U.S. Drug Enforcement Administration has finalized plans to further reduce the supply of oxycodone, hydrocodone and other commonly prescribed opioids by about 5 percent in 2023, ignoring complaints from patients and healthcare providers that a seventh consecutive year of cuts in opioid production would cause shortages and interfere with the treatment of pain patients.

In a notice published in the Federal Register, DEA said the reduced supply of opioids in 2023 would be “sufficient to meet all legitimate needs.”  The agency has broad legal authority under the Controlled Substances Act (CSA) to establish annual production quotas for drug manufacturers, based on estimated medical, scientific and research needs.  

The 5% production cut in 2023 for Schedule II opioids is not as steep as in prior years, but continues a trend that began a decade ago. Since their peak in 2013, DEA production quotas have fallen by 65% for oxycodone and 73% for hydrocodone.

It’s hard to find any evidence that reducing the opioid supply prevents overdoses. Prescription opioid use has fallen by nearly 50 percent in recent years, but drug deaths have climbed to record levels, fueled primarily by street drugs made with illicit fentanyl.

‘You’re Just Going to Kill People’

Over 350 people and organizations commented on the DEA’s new quotas during a 30-day public comment period that ended in mid-November. Many fear that further cuts in the opioid supply will lead to more suffering and suicides due to untreated pain.

“The DEA should not impose further reduction in the supply of Rx opioids for 2023. There is no correlation between prescriptions and diversion. All the street drugs out there come from Mexico by way of China, NOT a pharmacy,” wrote Anne Hoch. “The DEA are acting as doctors and determining how a doctor does his or her job. The government has to get out of healthcare and respect patient privacy again.”

“Stop reducing production of opioids. There already is a large shortage of pain meds. Why in the world are you reducing AGAIN??! Stop torturing Americans with your disastrous policies. It's quite clear that access to prescription opioids is a problem, so I'm not at all sure what you think you'll gain from reducing production -- you're just going to kill people,” wrote Amber Bullington.

Several people also pointed out that the CDC recently updated its opioid guideline to emphasize there is no hard limit on doses and to give doctors more flexibility in prescribing opioids.

“I believe that the DEA must take into consideration these revised Guidelines, because physicians will no longer be constrained to any arbitrary, hard and fast limit. More, rather than less, opioid daily dosages could be prescribed to certain individual patients who have high impact, intractable pain,” said an anonymous poster.

But the DEA said it would proceed as planned and take a wait-and-see approach to the revised guideline before making any changes to its aggregate production quotas (APQ).

“DEA will consider the impact of CDC's revised guidelines over time, in determining whether DEA may need to publish a revision to the currently proposed APQ values during the 2023 calendar year, when there is sufficient data to provide an understanding of the impact of the guidelines on the actual prescribing as practitioners seek to implement this guidance,” wrote DEA Administrator Anne Milgram, a former Attorney General of New Jersey who has no experience in medicine.

“In addition, DEA's regulations do not impose a maximum limit on the amount of medication that may be prescribed on a single prescription. DEA has consistently emphasized and supported the authority of individual practitioners under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards.” 

That comment about no “maximum limit” on prescriptions and the DEA supporting the “authority of individual practitioners” would come as a surprise to many doctors. For years, DEA task forces have targeted doctors who prescribe high doses of opioids deemed to be “outside the usual course of professional practice.” 

Last month the agency suspended the DEA license of Dr. David Bockoff, a California doctor who was treating 240 pain patients, including some from out-of-state who need high doses but were unable to find a local provider. Although Bockoff has practiced medicine for 53 years and has no record of any disciplinary action or complaints with the state medical board, the DEA alleged that he was “an imminent threat” to public safety. Milgram herself issued the order suspending Bockoff’s license to prescribe opioids and other controlled substances.

Within a week of the suspension, a distraught high-dose patient and his wife died in a double suicide in Georgia because he was unable to find another doctor willing to treat his pain. PNN has learned of a second Bockoff patient who died this past weekend, apparently from complications caused by opioid withdrawal. 

Employers Use Co-Pay Assistance Programs for Costly ‘Nonessential’ Drugs

By Julie Appleby, Kaiser Health News

Anna Sutton was shocked when she received a letter from her husband’s job-based health plan stating that Humira, an expensive drug used to treat her daughter’s juvenile arthritis, was now on a long list of medications considered “nonessential benefits.”

The July 2021 letter said the family could either participate in a new effort overseen by a company called SaveOnSP and get the drug free of charge or be saddled with a monthly copayment that could top $1,000.

“It really gave us no choice,” said Sutton, of Woodinville, Washington. She added that “every single FDA-approved medication for juvenile arthritis” was on the list of nonessential benefits.

Sutton had unwittingly become part of a strategy that employers are using to deal with the high cost of drugs prescribed to treat conditions such as arthritis, psoriasis, cancer, and hemophilia.

Those employers are tapping into dollars provided through programs they have previously criticized: patient financial assistance initiatives set up by drugmakers, which some benefit managers have complained encourage patients to stay on expensive brand-name drugs when less expensive options might be available.

Now, though, employers, or the vendors and insurers they hire specifically to oversee such efforts, are seeking that money to offset their own costs. Drugmakers object, saying the money was intended primarily for patients. But some benefit brokers and companies like SaveOnSP say they can help trim employers’ spending on insurance — which, they say, could be the difference between an employer offering coverage to workers or not.

It’s the latest twist in a long-running dispute between the drug industry and insurers over which group is more to blame for rising costs to patients. And patients are, again, caught in the middle.

Patient advocates say the term “nonessential” stresses patients out even though it doesn’t mean the drugs — often called “specialty” drugs because of their high prices or the way they are made — are unnecessary.

Some advocates fear the new strategies could be “a way to weed out those with costly health care needs,” said Rachel Klein, deputy executive director of the AIDS Institute, a nonprofit advocacy group. Workers who rely on the drugs may feel pressured to change insurers or jobs, Klein said.

Gaming the System to Save Money

Two versions of the new strategy are in play. Both are used mainly by self-insured employers that hire vendors, like SaveOnSP, which then work with the employers’ pharmacy benefit managers, such as Express Scripts/Cigna, to implement the strategy. There are also smaller vendors, like SHARx and Payer Matrix, some of which work directly with employers.

In one approach, insurers or employers continue to cover the drugs but designate them as “nonessential,” which allows the health plans to bypass annual limits set by the Affordable Care Act on how much patients can pay in out-of-pocket costs for drugs. The employer or hired vendor then raises the copay required of the worker, often sharply, but offers to substantially cut or eliminate that copay if the patient participates in the new effort.

Workers who agree enroll in drugmaker financial assistance programs meant to cover the drug copays, and the vendor monitoring the effort aims to capture the maximum amount the drugmaker provides annually, according to a lawsuit filed in May by drugmaker Johnson & Johnson against SaveOnSP, which is based in Elma, New York.

The employer must still cover part of the cost of the drug, but the amount is reduced by the amount of copay assistance that is accessed. That assistance can vary widely and be as much as $20,000 a year for some drugs.

In the other approach, employers don’t bother naming drugs nonessential; they simply drop coverage for specific drugs or classes of drugs. Then, the outside vendor helps patients provide the financial and other information needed to apply for free medication from drugmakers through charity programs intended for uninsured patients.

“We’re seeing it in every state at this point,” said Becky Burns, chief operating officer and chief financial officer at the Bleeding and Clotting Disorders Institute in Peoria, Illinois, a federally funded hemophilia treatment center.

The strategies are mostly being used in self-insured employer health plans, which are governed by federal laws that give broad flexibility to employers in designing health benefits.

Still, some patient advocates say these programs can lead to delays for patients in accessing medications while applications are processed — and sometimes unexpected bills for consumers.

“We have patients get billed after they max out their assistance,” said Kollet Koulianos, vice president of payer relations at the National Hemophilia Foundation. Once she gets involved, vendors often claim the bills were sent in error, she said.

Even though only about 2% of the workforce needs the drugs, which can cost thousands of dollars a dose, they can lead to a hefty financial liability for self-insured employers, said Drew Mann, a benefits consultant in Knoxville, Tennessee, whose clientele includes employers that use variations of these programs.

Before employer health plans took advantage of such assistance, patients often signed up for these programs on their own, receiving coupons that covered their share of the drug’s cost. In that circumstance, drugmakers often paid less than they do under the new employer schemes because a patient’s out-of-pocket costs were capped at lower amounts.

Brokers and the CEOs of firms offering the new programs say that in most cases patients continue to get their drugs, often with little or no out-of-pocket costs.

If workers do not qualify for charity because their income is too high, or for another reason, the employer might make an exception and pay the claim or look for an alternative solution, Mann said. Patient groups noted that some specialty drugs may not have any alternatives.

Patients Caught in the Middle  

How this practice will play out in the long run remains uncertain. Drugmakers offer both copay assistance and charity care in part because they know many patients, even those with insurance, cannot afford their products. The programs are also good public relations and a tax write-off. But the new emphasis by some employers on maximizing the amount they or their insurers can collect from the programs could cause some drugmakers to take issue with the new strategies or even reconsider their programs.

“Even though our client, like most manufacturers, provides billions in discounts and rebates to health insurers as part of their negotiations, the insurers also want this additional pool of funds, which is meant to help people who can’t meet the copay,” said Harry Sandick, a lawyer representing J&J.

J&J’s lawsuit, filed in U.S. District Court in New Jersey, alleges that patients are “coerced” into participating in copay assistance programs after their drugs are deemed “nonessential” and therefore are “no longer subject to the ACA’s annual out-of-pocket maximum.”

Once patients enroll, the money from the drugmaker goes to the insurer or employer plan, with SaveOnSP retaining 25%, according to the lawsuit. It claims J&J has lost $100 million to these efforts. None of that money counts toward patients’ deductibles or out-of-pocket maximums for the year.

In addition to the lawsuit over the copay assistance program efforts, there has been other reaction to the new employer strategies. In an October letter to physicians, the Johnson & Johnson Patient Assistance Foundation, a separate entity, said it will no longer offer free medications to patients with insurance starting in January, citing the rise of such “alternative funding programs.”

Still, J&J spokesperson L.D. Platt said the drugmaker has plans, also in January, to roll out other assistance to patients who may be “underinsured” so they won’t be affected by the foundation’s decision.

In a statement, SaveOnSP said that employers object to drug companies’ “using their employees’ ongoing need for these drugs as an excuse to keep hiking the drugs’ prices” and that the firm simply “advises these employers on how to fight back against rising prices while getting employees the drugs they need at no cost to the employees.”

In a court filing, SaveOnSP said drugmakers have another option if they don’t like efforts by insurers and employers to max out what they can get from the programs: reduce the amount of assistance available. J&J, the filing said, did just that when it recently cut its allotted amount of copay assistance for psoriasis drugs Stelara and Tremfya from $20,000 to $6,000 per participant annually. The filing noted that SaveOnSP participants would still have no copay for those drugs.

For Sutton’s part, her family did participate in the program offered through her husband’s work-based insurance plan, agreeing to have SaveOnSP monitor their enrollment and payments from the drugmaker.

So far, her 15-year-old daughter has continued to get Humira, and she has not been billed a copay.

Even so, “the whole process seems kind of slimy to me,” she said. “The patients are caught in the middle between the drug industry and the insurance industry, each trying to get as much money as possible out of the other.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

My Story: Why We’re Fighting the DEA

By Louis Ogden, Guest Columnist

I have been troubled by severe and chronic intractable pain since childhood, beginning at age 6.  I am now 72 years old. My earliest memories of pain are of aching in my legs so bad I remember crying myself to sleep.  My parents took me to doctors who said the aches were “growing pains” that would go away as I got older. 

My pain gradually got worse as I grew older and expanded to be body-wide. The worst pain of all was in my neck and upper back, along with incredibly severe head pain. It felt as if my skull was being crushed in every direction. I first remember having the head pain at age 12, but doctors had no answers for my parents and me. 

I finally got a diagnosis of fibromyalgia from a family doctor in 1990 at age 40. I can still remember his exact words when I asked him if there was anything he could give me for the pain.   

"Yes I could, but I won't because it would require opioids and you would be a junkie within two weeks,” the doctor said.  

I carried on with my life, usually with a tin of Excedrin in my pocket that I took to get me through each day. I did have many symptoms of fibromyalgia and it was good to finally have a diagnosis, but it didn’t seem to explain the crushing head pain.  

The pain grew so bad in my 40’s that I could no longer stand to do the demanding physical work required of an electrician and was forced to retire early. 

I was couch-bound most of the time and went on a 13-year search to find a solution to this painful existence. 

I saw many physicians and tried many treatments and medications, including opioids. Unfortunately, none of the therapies or medications eased my pain to tolerable levels. 

LOUIS and kristen OGDEN

Finding Relief With High Doses

In 2010, I sought out more aggressive pain care using high-dose opioid therapy as a last resort.  Dr. Forest Tennant of California took over my care. I think it was at my third appointment with Dr. Tennant when he told my wife Kristen and I that I probably would not have a very long life. I was 60 when he told us that bad news, but I am now 72 and still kicking thanks to his treatment protocol.   

After a thorough review of my medical records, a physical evaluation and various assessments, Dr. Tennant prescribed OxyContin, as well as oxycodone and morphine for breakthrough pain. He titrated me up to where I was comfortable and enjoying the highest quality of life I’d ever had as an adult.  The daily dose I was taking was close to 3,000 morphine milligram equivalent (MME), which is considered quite high. 

For 8 years, I continued on that same regimen. I did not need, nor did I ask for a higher dose, as I was doing great on the daily dose as stabilized.  

Dr. Tennant eventually diagnosed me with Arachnoiditis and Ehlers-Danlos Syndrome (EDS). These rare, but very painful syndromes account for my body-wide, complex, constant and severe pain, including the crushing head pain. I believe I inherited EDS from my mother, her mother, and the maternal line of descent going back at least 6 generations. The exact causes of my need for such high doses of opioids may never be proven, but probably include anomalies of absorption, metabolism and receptor damage due to EDS.  

Once titrated up to an effective dose, I was a very happy, well-adjusted person with a good quality of life, no longer couch-bound in agony and once again able to participate in social activities and perform household chores. My medicine enables this, and I have no sensation of pleasure or “high” of any kind. In fact, people that I meet have no idea that I am on a very high dose of opioids. I do not slur my words, nor am I disoriented. 

The DEA Gets Involved  

After Dr. Tennant was forced into retirement by the DEA in 2018 over unsubstantiated allegations of drug trafficking, I moved on to another doctor in California who kept lowering my dose. It left me not feeling well enough to stay active and enjoy my life, so I moved on to become a patient of Dr. David Bockoff, who assured me at my first appointment that he would do his best to help my pain.  He increased my dose to a level that allowed me to be much more comfortable.   

As PNN has reported, the DEA last month suspended Dr. Bockoff’s registration to prescribe opioids and other controlled drugs, which soon led to the death of one of his patients. Danny Elliott was so distraught over losing his pain medication that he committed suicide, along with his wife Gretchen. The Elliotts were friends of ours and confidants, as we have dealt for years with many of the same problems finding appropriate pain care.  

I am also now facing a life with no pain control and the very serious complications of withdrawal and untreated constant, severe pain.  This situation is very frightening to me, as my blood pressure may spike and I could possibly die of heart failure, an aneurysm or a stroke when/if I run out of medicine.   

The families of several of Dr. Bockoff’s patients, including my wife and I, have pooled our resources and retained the services of an experienced, well-qualified attorney who views our case as a violation of our civil rights. To the best of our knowledge, this is the first time that abandoned pain patients have fought back in such a manner.  If we prove our case with the DEA, the suspension order that prevents Dr. Bockoff from prescribing our medications could be lifted and we will get our good doctor back.   

If we do not win at this stage, we will take our case to the next legal step. In the meantime, some 240 patients of Dr. Bockoff are left with no help and no access to life-saving medications.   

It is my understanding that a few more pain management physicians are considering leaving their practices in the near future. As a result, thousands of additional pain patients may soon lose their lifelines to the medications they so desperately need to function. The DEA has a lot of blood on its hands, with possibly more to come. 

Louis Ogden and his wife Kristen live in Virginia. Dr. Tennant and the Tennant Foundation give financial support to Pain News Network and sponsor PNN’s Patient Resources section.  

Do you have a “My Story” to share? Pain News Network invites other readers to share their experiences about living with pain and treating it. Send your stories to editor@painnewsnetwork.org

Can Fentanyl Be Made Safer?

By Pat Anson, PNN Editor

Illicit fentanyl has been public health enemy #1 in the United States since 2016, when the DEA first declared there was a "fentanyl crisis" and warned that overdose deaths would increase due to the growing trade in street drugs laced with the potent synthetic opioid. That prediction sadly came true, as illicit fentanyl is now involved in about 71,000 U.S. overdose deaths a year. 

A team of scientists says it can reverse that trend by using sodium to make fentanyl far less dangerous, yet still effective in treating pain. 

“In its current form, fentanyl is like a weapon of mass destruction,” says Vsevolod Katritch, PhD, a computational biologist at the USC Michelson Center for Convergent Bioscience. “Our new collaborative work suggests that we could redesign the drug in such a way that we convert this frequent overdose killer to a much more benign but still effective analgesic.”

Katritch and colleagues at Washington University in St. Louis and Stanford University have published a study in the journal Nature demonstrating that chemically linking sodium to fentanyl can alter the way fentanyl binds to opioid receptors in the brain. In tests on laboratory mice, the modified drug was still an effective pain reliever, but didn’t have as many risky side effects. 

“We are desperately looking for ways to maintain the analgesic effects of opioids, while avoiding dangerous side effects such as addiction and respiratory distress that too often lead to death. Our research is still in its early stages, but we’re excited about its potential for leading to safer pain-relieving drugs,” Susruta Majumdar, PhD, an associate professor of anesthesiology at Washington University, said in a statement.,.

In modifying fentanyl with sodium, researchers developed a variation of the drug that still binds to mu-opioid receptors -- known as G-protein coupled receptors -- but also engages with a sodium ion binding site. That alters the pathway through which fentanyl reduces pain, making it possible for the drug to maintain most of its analgesic effects while also reducing the risk of respiratory depression leading to an overdose.

“The idea that the sodium ion, something we find in table salt, could modulate the activity of G-protein coupled receptors, such as these opioid receptors, is not new, but our group appears to be the first to successfully alter the chemistry of fentanyl so that it interacts with the sodium site on the receptor,” says Majumdar, who believes the same technique can be used in other medications, including other opioids, to make them safer.  

“Almost one-third of all drugs currently on the market — from blood pressure drugs to diabetes drugs to analgesics like fentanyl — bind to various G-protein coupled receptors, so it may be possible to make many drugs more effective, and to limit their side effects, by altering how they bind with such receptors.”

Researchers say further study is needed to prove that their altered version of fentanyl will work in humans, but they believe they've found a way to potentially improve its safety and those of other painkillers.

The research appears promising and may someday benefit pain patients, but it overlooks a simple fact: most of the fentanyl that is killing people is illicitly produced. And the clandestine labs, drug cartels, pill pressers and drug dealers responsible for the vast majority of overdoses will have no interest in adding sodium to their counterfeit pills and other fentanyl-laced drugs to make them safer.

The Nature study also perpetuates some longstanding myths about the overdose crisis, calling fentanyl and other prescription opioids a "major public health concern due to their adverse side effects."

But as pain management expert Dr. Lynn Webster pointed out in a 2019 PNN column, calling fentanyl a "weapon of mass destruction" is a bit of an overreach. Fentanyl has been legally used for decades -- safely and effectively -- as a surgical analgesic, and in transdermal patches and lozenges intended for patients with severe pain from cancer and other intractable pain conditions.

"Each of these new uses of fentanyl exposed millions of Americans to the drug without evidence of an inordinate degree of harm if it was used as directed," Webster wrote. "The opioid crisis is now largely driven by nonpharmaceutical fentanyl and fentanyl analogs, not prescription fentanyl."

Few pain patients who use fentanyl as directed become addicted or overdose, although many do become dependent on the drug to continue working, perform simple household chores, maintain personal hygiene, and have some quality of life. Modifying prescription fentanyl with sodium to make it safer might benefit some of those patients, but it will likely have no effect on the fentanyl crisis or prevent many overdoses.