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.

Stopping Rx Opioid Therapy Raises Risk of Overdose

By Pat Anson, PNN Editor

Discontinuing opioid therapy for people with chronic pain raises the risk of a patient dying from an overdose, according to a new Canadian study that calls for better guidance for healthcare providers on the risks associated with abrupt tapering.

Researchers analyzed the medical histories of over 14,000 pain patients in British Columbia who were on long term opioid therapy from 2014 to 2018 – a period when physicians in Canada and the United States were being urged to restrict opioid prescriptions due to a worsening overdose crisis. The vast majority of patients studied were either tapered to a lower dose or their opioid treatment was discontinued, regardless of whether they showed signs of opioid use disorder (OUD).  

The study findings, published in PLOS Medicine, show that discontinuing opioid therapy for pain was associated with increased overdose risk. The association was even stronger for the small minority of patients diagnosed with OUD. In total, 530 people in the study (3.8%) experienced either a fatal or non-fatal overdose, with 120 of them dying.

“Our findings underscore the need for healthcare providers and policymakers to carefully consider potential unintended adverse effects of discontinuing opioid treatment for chronic pain when developing prescribing interventions and making practice decisions,” wrote lead author Mary Clare Kennedy, PhD, a Research Scientist with the BC Centre on Substance Use and a Research Fellow at the University of British Columbia.

“Given the harms of opioid treatment discontinuation identified in this and past studies, non-consensual and abrupt discontinuation of opioid treatment for pain is contraindicated in almost all instances.”

Kennedy and her colleagues were unable to determine what substances were involved in the overdoses, but they believe some patients who had their opioid therapy stopped may have resorted to illicit fentanyl and other street drugs to manage their pain, withdrawal and other symptoms. Over 73% of the overdose deaths that occurred in British Columbia during the study period involved fentanyl.

Previous studies have also found that opioid tapering raises the risk of an overdose and mental health crisis. A study published last year in JAMA found that tapered patients were 68% more likely to be treated for opioid withdrawal, drug overdose or alcohol intoxication, and they were twice as likely to experience depression, anxiety or a suicide attempt.

The FDA warned in 2019 that rapid tapering or abrupt discontinuation of opioids could result in serious harm to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.

‘Reckless Mistreatment of Patients’

Despite this growing body of evidence, forced tapering and opioid discontinuation continues – some of it caused by the heavy-handed tactics of law enforcement. Over 200 pain patients were recently cut off from opioids after their California doctor had his DEA license suspended without warning. One patient and his wife died by suicide within a week of the DEA’s action.

“Not only are we collectively causing harm, we are failing to stop causing harm even when we agree that we're causing it, which is actually worse,” says Stefan Kertesz, MD, an associate professor at the University of Alabama at Birmingham, who is leading a study of pain patient suicides.

Kertesz says regulators, insurers, journalists and law enforcement have misinterpreted overdose studies to suggest that opioid prescribing, particularly at higher doses, was the root cause of the overdose crisis.  

“Many clinicians and policymakers engaged in aggressive extrapolation that went far beyond the data. Many journalists and legal plaintiffs described the prescriptions in a way that aggravated matters. They made dose into a fetish, a performance metric, and a threshold for law enforcement,” Kertesz told PNN. “Dose based quality metrics, payor standards and legal investigation thresholds incentivize reckless mistreatment of patients.

“My ultimate question is when will agencies like the National Committee for Quality Assurance, the Office of Inspector General, and law enforcement actually come to appreciate the evidence in play?”

It took six years, but the CDC recently revised its 2016 opioid guideline to include specific language warning of the dangers of tapering or discontinuing opioids.

“Clinicians should avoid abrupt discontinuation of opioids, especially for patients receiving high dosages of opioids, should avoid dismissing patients from care, and should ensure appropriate care for patients with pain and patients with complications from opioid use,” the revised guideline states.

Spinal Cord Stimulators Fail to Reduce Opioid Use

By Pat Anson, PNN Editor

A large new study is raising questions about the long-term effectiveness of spinal cord stimulators and whether they really help patients reduce their use of opioids and other pain treatments.

Researchers at the University of California San Francisco (UCSF) School of Medicine analyzed health data for 1,260 patients who received permanent stimulators and found that — when compared to a control group — the devices did not reduce their use of opioids, epidurals, corticosteroid injections or radiofrequency ablation after two years. About a fifth of the patients experienced complications so severe the devices had to be removed or revised.

Spinal cord stimulators (SCSs) are considered an invasive treatment of last resort for people with chronic back or leg pain, because the devices have to be surgically implanted near the spine and connected to batteries placed under the skin. The implants send electrical impulses into the spine to mask pain.

About 50,000 SCSs are implanted annually in the U.S. and their use is growing – in part because of the belief they’ll reduce the need for opioids and other pain therapies.

But UCSF researchers found that SCS patients actually filled more opioid prescriptions after one year than a control group of pain patients (CMM) who did not get the devices. The use of other medications and procedures by SCS patients declined slightly after one year, but there were no significant differences between the two groups after two years.

“The lack of reduction in pharmacotherapy, epidural and facet corticosteroid injections, and radiofrequency ablations at 2 years among patients receiving SCS compared with those receiving CMM suggests that SCS was providing insufficient pain relief to forego other therapies or improve rates of depression or anxiety, as prescriptions for these drug classes did not decline,” lead author Sanket Dhruva, MD, an Assistant Professor of Medicine at UCSF, wrote in JAMA Neurology.

“Because most patients still had their permanent SCS in place at 2 years, some may receive prolonged benefit from this modality, although we were not able to identify this through reductions in opioid use or nonpharmacologic pain interventions.”

Researchers also found that the total cost of care was about $39,000 higher for SCS patients in the first year, while health costs were similar for the two groups in the second year.

‘Sobering Insights’

"The findings appear to belie the popular belief that SCS may result in reduced opioid medication usage or overall fewer physician visits in the years immediately following device implant," wrote Prasad Shirvalkar, MD, and Lawrence Poree, MD, both from the UCSF Division of Pain Medicine, in an accompanying editorial.

“Using robust propensity matching, the present study provides sobering insights that SCS does not appear to reduce chronic opioid use or the utilization of health care resources compared with CMM in the first 2 years after implant. We believe this will help mitigate excessive enthusiasm of SCS as a panacea for chronic pain syndromes and illuminate biases of SCS hype cycle that can possibly be fueled by industry-related conflicts of interest.”

Stimulators are no longer limited to patients with chronic back, neck and leg pain. Last year the FDA expanded the use of SCSs to include pain from diabetic neuropathy. Stimulators are also now being used on patients with Complex Regional Pain Syndrome (CRPS).

A 2018 study by a team of investigative journalists found that SCSs have some of the worst safety records of medical devices tracked by the FDA. A 2020 FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 device malfunctions.

NSAIDs May Worsen Arthritis Inflammation

By Pat Anson, PNN Editor

Ibuprofen, naproxen and other non-steroidal anti-inflammatory drugs (NSAIDs) are often recommended as safer and more effective pain relievers than opioids. As evidence, anti-opioid activists often cite a 2018 study that found NSAIDs worked “significantly better” than opioids in reducing pain intensity for patients with osteoarthritis.

That study by VA researcher Erin Krebs, MD, is cited nearly a dozen times in the newly revised CDC opioid guideline, which recommends that patients avoid opioids and use topical or oral NSAIDs for osteoarthritis pain.

But according to a new long-term study, NSAIDs may actually worsen inflammation and weaken cartilage in patients with knee osteoarthritis, contributing to a painful joint condition called synovitis.

“The goal of our study was to analyze whether NSAID treatment influences the development or progression of synovitis and to investigate whether cartilage imaging biomarkers, which reflect changes in osteoarthritis, are impacted by NSAID treatment,” says lead author, Johanna Luitjens, MD, a postdoctoral scholar in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco.

“NSAIDs are frequently used to treat pain, but it is still an open discussion of how NSAID use influences outcomes for osteoarthritis patients. In particular, the impact of NSAIDs on synovitis, or the inflammation of the membrane lining the joint, has never been analyzed using MRI-based structural biomarkers.”

Luitjens and her colleagues enrolled 277 people with moderate to severe osteoarthritis who used NSAIDs for at least one year, comparing them to a control group of 793 patients who were not treated with NSAIDs. All participants underwent an MRI of the knee at the start of the study and had another MRI four years later. 

The results showed no long-term benefits from NSAID use. The initial MRIs found joint inflammation and cartilage quality were worse in the participants taking NSAIDs, and their knee joints deteriorated even more after four years. 

“In this large group of participants, we were able to show that there were no protective mechanisms from NSAIDs in reducing inflammation or slowing down progression of osteoarthritis of the knee joint,” said Luitjens, who will present her findings next week at the annual meeting of the Radiological Society of North America (RSNA).

Luitjens says there are two possible reasons for the ineffectiveness of NSAIDs. One is that the anti-inflammatory effects of NSAIDs may not be sufficient to prevent synovitis. It’s also possible that patients with synovitis who use NSAIDs may be more physically active due to pain relief, which could have worsened their synovitis. 

In either case, Luitjens believes more evidence is needed to support the continued use of NSAIDs as a treatment for osteoarthritis.

“The use of NSAIDs for their anti-inflammatory function has been frequently propagated in patients with osteoarthritis in recent years and should be revisited, since a positive impact on joint inflammation could not be demonstrated,” she said.

The 2018 Krebs study did not look at how NSAIDs affected joint inflammation. It focused mainly on pain intensity, function and quality of life, and found few differences between opioids and NSAIDs, leading Krebs to conclude that opioids were “not superior” to NSAIDs. As my late colleague Roger Chriss pointed out, researchers also found no harmful effects in patients who took opioids for a year. There was no opioid misuse, addiction or overdoses — a detail rarely mentioned in news coverage of the study.

Osteoarthritis is a joint disorder that leads to thinning of cartilage and progressive joint damage. Knee osteoarthritis is quite common and affects over 250 million people worldwide. Nearly 40 percent of Americans over the age of 45 have some degree of knee osteoarthritis.

DEA Plans Further Cuts in Rx Opioid Supply

By Pat Anson, PNN Editor

For the seventh consecutive year, the U.S. Drug Enforcement Administration is planning to cut the supply of prescription opioids, reducing them in 2023 to levels not seen in nearly two decades.

DEA sets production quotas for opioids and other controlled substances annually, after consulting with the CDC, FDA and individual states about their projected medical and research needs. Based on that input, the DEA is lowering the supply of Schedule II opioids such as oxycodone and hydrocodone by about 5 percent next year.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2023 will decline on average 5.3 percent from calendar year 2022 levels. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone,” the DEA said in a notice published in the Federal Register.   

The production cut in 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, production quotas have fallen by 65% for oxycodone and 73% for hydrocodone, the two most widely prescribed opioids.

OXYCODONE PRODUCTION QUOTAS (KILOGRAMS)

SOURCE: DEA

The primary goal of the DEA in lowering opioid production is to reduce the risk of diversion, abuse and overdose, but it’s hard to find any evidence the policy is working. Prescription opioid use has fallen by 48% in the last five years, but opioid overdose deaths have climbed to record levels, fueled primarily by street drugs made with illicit fentanyl, a synthetic opioid 50 to 100 times stronger than morphine.

Although DEA is arresting and prosecuting illicit fentanyl dealers, it also continues to actively target doctors who prescribe high doses of opioids. This month it suspended the DEA license of a California doctor for unknown reasons, which led to the death of a chronic pain patient and his wife in a double suicide.

“It’s the end of the road for me with doctors,” Danny Elliott posted on Twitter a few days before his death. Elliott had lived with severe headaches for over two decades and was despondent that he was out of pain medication and unable to find a new doctor.

Low Risk of Diversion    

DEA is required under federal law to estimate the amount of prescription opioids that will be diverted through loss or theft, and then subtract it from the annual production quota. But those estimates reveal just how small the opioid diversion problem actually is.

Using information gathered from prescription drug monitoring programs (PDMPs), pharmacies, hospitals and others in the drug supply chain, DEA estimates that less than one percent of oxycodone (0.3%) and hydrocodone (0.42%) will be diverted for use by someone they were not intended for.

The DEA’s 2023 production quotas are also based on an old recommendation from the CDC that prescribers should “avoid increasing dosages of opioids beyond 90 MME for patients with chronic pain.”  CDC recently revised its opioid guideline to remove the 90 MME dosage threshold. The new guideline is more flexible and encourages doctors to make treatment decisions based on the individual needs of the each pain patient and not on any hard limits.

The DEA is accepting public comments on its production quotas until Thursday, November 17. The public response so far has been muted – only 47 comments as of this writing -- likely because the quotas have received little publicity from the media or the DEA itself.

Most of the comments that have been received are critical of DEA plans to reduce the supply of amphetamines and other stimulants used in treating attention deficit hyperactivity disorder (ADHD).  Some of those drugs are already in short supply, but DEA said it has “grown increasingly concerned” that ADHD medications are being diverted and abused by young adults.

To leave your comment on the DEA’s 2023 production quotas, click here.

DEA Suspension of Doctor’s License Leads to Double Suicide

By Pat Anson, PNN Editor

Another chronic pain patient, along with his wife, has fallen victim to the Drug Enforcement Administration’s ongoing war against doctors who prescribe opioid medication.  

61-year-old Danny Elliott and his 59-year-old wife Gretchen were found dead in their Georgia home Monday. Police are calling it a double suicide.

Family and friends say Elliott – who lived with severe intractable pain for over two decades -- was distraught over the suspension of his doctor’s DEA license to prescribe opioids and other controlled substances. Dr. David Bockoff, a longtime pain management specialist in Beverly Hills, California, was notified about the suspension by a Department of Justice attorney last week.

“OMG. I called for my phone appt on Tuesday, apparently just a couple of hours after they took his license to prescribe. Because I was due for my next Rx’s, I’m now totally out,” Elliott posted on Twitter days before his death.

“It’s the end of the road for me with doctors. Not sure what happens now but it’s going to be brutal.”

No reason was given for the suspension, according to Bockoff. The DEA confirmed to PNN that Bockoff’s license to prescribe was suspended, but declined to comment further because the case is under administrative review.

Danny and Gretchen Elliott

“Their blood is on the DEA’s hands,” Bockoff said about the deaths of the Elliotts.

Some of Bockoff’s patients, including Elliott, traveled thousands of miles from out of state to see him because they were unable to find doctors locally who were willing to treat their pain. Bockoff can still practice medicine in California, but without an active DEA license he cannot prescribe opioids – which are essential, life-giving medications to patients like Elliott.

“I talked to my sister on Sunday,” said Eric Welde, Gretchen’s brother. “They were very distraught because they heard that Doctor Bockoff was not going to be able to grant them another prescription because the DEA had gone after him and said he couldn’t prescribe anymore, otherwise he was going to jail or something. That hit them very hard like a ton of bricks.”

Welde says his brother-in-law suffered from severe chronic headaches after he was electrocuted in a freak accident 22 years ago. A former pharmaceutical rep, Elliott was unable to work and was dependent on opioids to have any quality of life.  In the days before his death, Welde says Elliott was so desperate for pain relief that he tried unsuccessfully to buy drugs on the black market.  

“I’m angry at the DEA. And I’m angry at the whole medical system. Because he was clearly in pain. He was not a junkie,” Welde told PNN. “There’s this whole stigmatism towards pain management that you should just be able to get over it. It’s like telling a diabetic that you don’t need insulin anymore. And it’s brutally wrong.   

“But it’s perfectly acceptable to bring thousands of pounds of illegal fentanyl over and sell that on the black market. But this is a more worthwhile cause for the DEA, which just absolutely floors me.”

Bockoff Patients ‘Among the Sickest’

“This unwarranted harassment of long-established pain doctor David Bockoff is almost beyond belief,” says Kristen Ogden, whose husband Louis is a patient of Bockoff’s. The Ogdens live in Virginia and traveled monthly to California to have Louis’ prescriptions written and filled. 

“These patients, including my husband Louis, are among the sickest people there are and yet they have been able to achieve and maintain a good quality of life with Dr. Bockoff's care and the pain medications he prescribed,” Ogden said. “Now Danny Elliott, a man Louis and I were privileged to call our friend, has ended his life because he could no longer endure such horrific pain and his sweet, caring wife Gretchen apparently chose not to live on without him. Who can explain why it was okay to take away this man's medication?” 

“Just sick over Danny and Gretchen. I'm a Bockoff patient as well, all of my meds were due to fill the day his DEA registration was suspended,” says Anne Fuqua, a disabled nurse in Alabama who lives with dystonia and arachnoiditis, two painful conditions that cannot be cured.   

Fuqua and Louis Ogden are both former patients of Dr. Forest Tennant, whose office and home in California were raided by the DEA in 2017.  A DEA search warrant alleged that Tennant ran a drug trafficking organization because many of his patients came from out-of-state and were on high doses of opioids. No criminal charges were ever filed against Tennant, who retired from clinical practice a few months after the raid. 

“I’m alive today because Dr. Tennant and later Dr. Bockoff chose to put themselves on the line for high-dose patients like me,” says Fuqua.  

It cannot be overstated how difficult it is for chronically ill patients like Fuqua to find new doctors. Many pain management doctors have stopped taking new patients or retired, fearing they could be targeted by DEA or other law enforcement agencies for prescribing opioids. 

For some patients, the pain and anxiety become overwhelming. Jennifer Adams, a 41-year-old Montana woman and former patient of Tennant, ended her life in 2018. Friends say Adams’ anxiety about losing her pain medication “was eating her alive.”

‘Not Helpful to Patients’ 

Dr. Bockoff has practiced medicine in California for 53 years and there is no record of him facing any disciplinary action or complaints filed with the state medical board. His office was searched by DEA agents about a year ago and patient records were taken at that time.

Bockoff says there was no warning about his suspension or the reasons for it. 

“You’d have to ask them what their motivation is. I don’t know. But I would say it certainly affects patients. Any patient who has chronic intractable pain is adversely affected by this action,” Bockoff told PNN. “It’s quite scary to think that a person in pain all of a sudden is unable to get their needed medication.” 

Bockoff says the DEA and DOJ agents who visited his office last week left behind a list of emergency rooms in the Los Angeles area, saying they didn’t want any of his patients to go into withdrawal. Such a list would be of no use to out-of-state patients and of little use to those locally. Many patients resist going to emergency rooms because they fear their pain won’t be treated or they’ll be viewed as drug seekers. 

“I’m not sure that’s helpful to my patients,” Bockoff said.       

Legal experts say the DEA has the power to suspend a doctor’s license in “emergency” situations for “imminent danger to the public health or safety.” A doctor then has 30 days to appeal the suspension to an administrative law judge, a process that can take months or years to resolve – too long for patients who have a limited supply of medication. 

While the DEA has no authority to practice medicine or regulate it, the effects of its decisions are far-reaching on both doctors and patients.  

“They’re certainly making judgements on the practice of medicine and they’re not qualified to do so,” said Michael Barnes, an attorney and chair of the Center for U.S. Policy, a non-profit that seeks to improve healthcare and drug policy. “The DEA is a one trick pony. It knows how to raid. It doesn’t regulate and so it employs it’s war on drug tactics against prescribers, including those who have no criminal intent.” 

Ironically, the suspension of Bockoff’s license comes at a time when opioid hysteria appears to be receding, as more people become aware that street drugs are responsible for the vast majority of overdoses.

This month the CDC revised its controversial opioid guideline, giving doctors more flexibility in using their own judgement to prescribe opioids. In June, the U.S. Supreme Court ruled unanimously in favor of two doctors appealing their convictions for “overprescribing” opioids, saying doctors can prescribe opioids outside the usual standard of medical care, as long as they act in good faith.

The California Medical Board is also modifying its hard stance on opioid prescribing, which resulted in hundreds of threats of disciplinary action against doctors who prescribed high doses or had patients who overdosed. 

None of these efforts, however, have reined in the DEA or prevented tragedies like the suicides of Danny and Gretchen Elliott.

CDC Revises Opioid Guideline, But Can It Undo the Damage to Pain Care?

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has released a long-awaited final update to its controversial opioid prescribing guideline, expanding the recommendations to include patients suffering from short and long-term pain, while at the same time giving doctors more flexibility when prescribing opioids.

Although voluntary and only intended for primary care providers treating chronic pain, the original 2016 guideline was adopted as a mandatory opioid policy by many states, insurers, medical societies and even law enforcement agencies, resulting in millions of patients being reduced to lower ineffective doses or taken off opioids and forced into withdrawal. The newly revised guideline is intended to end the “one-size-fits-all” approach to pain care and a public health experiment gone wrong.

“Fundamentally, the framing of the guideline is that pain happens in many different ways, in different intensities, and patients respond to different treatments in different ways. And so it is paramount that clinical decisions are based on the individual needs of the patient,” said Christopher Jones, PharmD, Acting Director of CDC’s National Center for Injury Prevention and Control and a guideline co-author.

“In some cases opioids, even opioids at high doses, are the right thing to do for the patient. It’s more about working with the patient to set expectations and goals and look at the full range of treatments. And if opioids are the right thing or opioids plus non-pharmacological treatments, or opioids plus NSAIDs, if that’s the right thing and the patient is doing well and meeting their goals, this guideline supports that. It doesn’t dictate any particular type of care that any particular patient has to receive.”

Benefits vs Risks

To be clear, the revised guideline still takes a dim view of opioid pain medication and its potential to result in addiction and overdose. Doctors are advised to “maximize” the use of non-opioid drugs and non-pharmacological treatments, and should “only consider initiating opioid therapy if expected benefits for pain and function are anticipated to outweigh risks to the patient.” When opioids are prescribed, it should be at the “lowest possible effective dose.”   

Other notable changes in the guideline:

• A more cautious, slower approach to opioid tapering that strongly encourages patient buy-in before doses are reduced

• Drug testing only recommended when “appropriate.” Doctors should first “consider the benefits and risks of toxicology tests”

• Instead of “extreme” caution about taking opioids with benzodiazepines and other anti-anxiety drugs, “particular” caution is recommended

• Patients should not be dismissed for failing a drug test or because of information found in prescription drug databases (PDMPs)

Importantly, the revised guideline also removes a recommendation in the 2016 guideline that daily opioid doses not exceed 90 MME (morphine milligram equivalents), which was widely seen as a hard limit. It is replaced with cautionary language about doses above 50 MME being “more likely to yield diminishing returns.”  

“There are tweaks, but I think they are tweaks that are meaningful. That doesn’t mean its not still built on a rotten core,” says Kate Nicholson, Executive Director of the National Pain Advocacy Center (NPAC), who belonged to an independent advisory panel that advised the CDC to drop all references to MME.

Nicholson is concerned the 50 MME threshold – which is mentioned two dozen times in the revised guideline – will be misapplied as the new hard limit.

“They still overly focus on MME’s,” she told PNN. “They do qualify it whenever they mention it, but it’s still there, it’s there a lot, and it’s aligned strongly with risk. My concerns are misapplication, even though they say repeatedly ‘Do not apply this as a strict threshold.’”

Nicholson is also concerned about the guideline’s expansion beyond chronic pain (pain lasting three months or more) to include people with short-term acute pain from trauma or surgery, as well as “sub-acute” pain lasting one to three months.

“It’s good to cover all pain and not just single out chronic pain. So in theory I think it’s fine, but in practice, given that they acknowledge again and again the problems of the 2016 guideline. Usually, you check your safety features on the airplane before you expand the fleet. And they didn’t. They did it all at once,” she said. “I also have concerns that it’s a clinical practice guideline written mostly by non-clinicians and by people who are not experts in pain. And it’s now going to cover how all pain should be treated?”

For some patient advocates, no amount of revisions are acceptable. They want the CDC guideline revoked.

“False claims of one-size-fits-all dose thresholds are alive and well in this final draft. More than ever, I am convinced that the CDC must be restricted by law from issuing practice guidelines of this type,” says patient advocate Richard “Red” Lawhern. “It doubles down on lies and cherry-picked research intended to further suppress opioid prescribing at the expense of undertreating patients and driving clinicians out of pain management practice.”

Most of the mainstream media coverage of the revised guideline portrayed it as a weaker or softened version of the 2016 guideline. That is puzzling to Andrew Kolodny, MD, founder and president of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), who believes the new guideline is “much stronger” than the original.

“Press coverage of the CDC opioid guideline is wacky,” Kolodny wrote on Twitter. “CDC issued a guideline much stronger than the 2016 version (high dose defined as 50 MME/day instead of 90) but press headlines say CDC softened guideline.”

Reversing the Damage

Many patient advocates believe it will be hard to unwind the damage caused by the 2016 guideline to patients, pain management practices, and the healthcare system in general.

“Many laws, regulations, and policies were implemented from the rigid application of the 2016 opioid dosage thresholds. I believe this means many physicians may remain reluctant to prescribe opioids when indicated for chronic pain, and patients may continue to find access to treatment a challenge,” said Dr. Lynn Webster, Senior Fellow at the Center for U.S. Policy and past president of the American Academy of Pain Medicine

“To reverse the damage, the CDC could take an active and vocal public role in publicizing the statements about the guideline not being a law, regulation or policy. The agency should make sure that governmental and enforcement entities know there’s a new CDC statement on these matters.”

Chris Jones said the CDC would monitor how the revised guideline is implemented by states, insurers and others to prevent further misapplication. But he was vague about how it would be done, saying it needs to be handled on a case-by-case basis and while recognizing that “states do what states do.” The CDC has no legal authority to enforce its recommendations.

 “As with any clinical practice guideline, the work doesn’t stop today. It really starts as we engage with the clinical community, as we engage with patient organizations with educational opportunities. Certainly engaging with insurers and others to say, ‘Here’s the latest evidence about the range of treatment options that can be effective,’” he told PNN. “But we’re still working through, from a policy perspective when we see misapplication, how to respond to that.”

Jones said he would be speaking next month to the National Conference of State Legislatures about the revised guideline and to reinforce the need for individualized patient care. He and the other guideline co-authors also published an op/od in The New England Journal of Medicine that cautions providers about misapplying the CDC’s recommendations.

Webster thinks the CDC’s efforts to combat addiction and overdoses should be refocused on illicit fentanyl and other street drugs, which are involved in the vast majority of drugs deaths. In 2021, nearly 108,000 Americans died from overdoses, a record number.

“I think it is important to remember that the goal of the guideline was to reduce the number of overdose deaths by reducing the opioid supply or amount prescribed. It hasn’t worked out that way,” Webster said. “Over the past decade, opioid prescribing has plummeted, but the number of overdoses has skyrocketed. The CDC should now focus on the cause of most opioid-related overdose deaths, which is to bring attention to the social and economic factors that create the demand for so many Americans to escape the pain of living.” 

Study Finds Non-Opioid Pain Relievers Effective for Arthroscopic Surgery

By Pat Anson, PNN Editor

Patients recovering from minimally invasive shoulder or knee surgery do just as well with non-opioid pain relievers as those who use opioids, according to a new study at McMaster University and Hamilton Health Sciences (HHS) in Canada.

The study, published by the Journal of the American Medical Association (JAMA), looked at 193 outpatients who had arthroscopic surgeries on their knees or shoulders at three hospitals in Hamilton, Ontario.

About half received standard care with opioids for postoperative pain, while the other half received naproxen and acetaminophen for pain, as well as pantoprazole, a medication normally used to treat heartburn and acid reflux. An emergency supply of opioids was available to both groups, if needed, for additional pain relief.

After six weeks, patients in the opioid group had used an average of 72.6 mg of opioids, compared to 8.4 mg in the opioid-sparing group. Two patients in the opioid-sparing group asked for opioid medication after discharge. Researchers say there were no significant differences in pain levels, patient satisfaction or adverse events between the two groups. 

“This study clearly shows that many of these surgical patients can be treated safely without opioid medications in a select population,” said lead author Olufemi Ayeni, MD, a professor of surgery at McMaster and an orthopedic surgeon at HHS. “Furthermore, by reducing the number of opioids prescribed, we can collectively reduce the development of a reservoir of unused medications that can cause harm to many in society.” 

Over the past decade, the number of arthroscopic surgeries has soared in North America. About one million arthroscopies are performed annually in the United States and 100,000 in Canada. Several studies, however, have that found arthroscopic surgeries provide only temporary relief from knee pain and do not improve function long term.

To be clear, there is no comparison between arthroscopies and highly invasive surgical procedures such as heart bypass surgery.  Arthroscopies are a type of “keyhole” surgery in which the surgeon makes a small incision and inserts a tiny camera and instruments to diagnose and repair damaged ligaments or joints. The procedure often takes less than an hour and patients are sent home the same day — so there is less need for pain medication.

A recent analysis of nearly half a million minimally invasive surgeries in the U.S. found that the number of opioid pills prescribed to patients fell by 50% since 2017. Hospitals are increasingly using acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), gabapentinoids and other non-opioids for post-operative pain.  

Most Americans are more worried about treating post-operative pain than they are about becoming addicted to opioids. A 2021 Harris poll found that nearly 8 out of 10 U.S. adults believe opioids are sometimes necessary to manage pain after surgery and 60% prefer opioids over OTC pain relievers.

Why Troches Make Medications More Effective

By Dr. Forest Tennant, PNN Columnist

We regularly get emails from people who have gastrointestinal problems or tell us a particular medication is ineffective for them.  Pills and other oral medications are not always the best way to treat Adhesive Arachnoiditis (AA) or its related diseases.

The problem is that the stomach, intestine and liver don’t assimilate and metabolize more than 30 to 50 percent of the swallowed oral dose. Oral medications may also cause gastric irritation or even bleeding, and the drug may require an hour or more to be effective. Persons with AA and Ehlers-Danlos Syndrome (EDS) may have gastrointestinal dysfunction, which can make some oral medications like opioids almost totally ineffective.

If you are experiencing gastrointestinal problems or believe some of your medications are ineffective, we suggest you try using troches (the Greek pronunciation is “tro-key”). Troches are essentially lozenges that contain medication. They are placed in the mouth between the tongue and cheek until the medication dissolves.

The ancient Egyptians made some of the first troches from honey, herbs and spices to treat sore throats. Medicines introduced into the body this way bypass the digestive system and deliver their active ingredients directly into the blood stream through blood vessels under the tongue and in the cheek.

Superior Traits of Troches

Troches are a superior way to administer many of the key medications and hormones required to treat AA, and its related problems of Tarlov cysts and EDS. Some of these medications, like ketamine and oxytocin, are essentially ineffective if swallowed. 

• More potent than swallowed medication 

• Fast acting – within 10 minutes 

• No direct gastrointestinal irritation 

• Can reduce reliance on opioids 

• Avoids injections and suppositories

A troche must be compounded by your local pharmacy.  Every community today has pharmacies that will make or “compound” troches. For better pain relief and control of AA, Tarlov cysts and EDS, we highly recommend that patients and medical practitioners take the advanced step in therapeutics and begin to use troches. 

Forest Tennant, MD, DrPH, is retired from clinical practice but continues his research on the treatment of intractable pain and arachnoiditis. This column is adapted from a bulletin recently issued by the Arachnoiditis Research and Education Project. Readers interested in subscribing to the bulletins should click here.

The Tennant Foundation gives financial support to Pain News Network and sponsors PNN’s Patient Resources section.   

How Supporters of CDC Opioid Guideline Hijacked Public Hearing

By Pat Anson, PNN Editor

A public hearing on the CDC’s controversial opioid guideline was dominated by anti-opioid activists, who took most of the speaker slots after being tipped off about the hearing by CDC insiders, PNN has learned.   

At issue is a January 28, 2016 public hearing in Atlanta by the CDC’s Board of Scientific Counselors (BSC), an advisory panel that later voted unanimously to recommend the agency’s guideline, which discourages doctors from prescribing opioids for chronic pain. At the time, the CDC was under growing criticism for the secretive process used in drafting the guideline, which allowed for little input from the public, pain specialists and patients.

Faced with a congressional inquiry and accused of “blatant violations” of federal law, CDC postponed release of the guideline, opened a 30-day public comment period, and announced plans for a public hearing. But that hearing was essentially hijacked by anti-opioid activists who were alerted by Dr. Roger Chou, one of the guideline’s co-authors.

PNN has obtained a January 8, 2016 email from Chou to Dr. Andrew Kolodny, Executive Director and founder of PROP (Physicians for Responsible Opioid Prescribing), PROP president Dr. Jane Ballantyne, PROP vice-president Dr. Michael Von Korff, and PROP board member Dr. Gary Franklin. Chou wanted to make sure PROP members and other guideline supporters spoke at the Jan. 28 hearing.

“I was hoping you could help spread the word for folks who are willing and able to help provide some balanced public comments; otherwise much of the public comments are going to be dominated by pharma. The CDC guideline is going to come under a lot of scrutiny by Congress and others so comments coming from credible people would be of great help,” Chou wrote in his email.

“The public comment period at the meeting is 90 minutes long and those who wish to speak must sign up in advance; the slots are first come, first serve, so those who want to do this they will need to sign up quickly as I’ve been told that pharma is already gearing up to take as many slots as they can.”

Kolodny responded quickly to Chou’s email, urging Ballantyne and the other PROP members to sign up as speakers. Although a public notice about the CDC hearing was not officially published in the Federal Register until January 11 -- three days later – the notice was put on “public display” in the Federal Register on Jan. 8, along with a link that allowed speakers to sign up early.

“We need to register ASAP if we hope to get a spot to give oral remarks (which can be done over the phone). I think it’s best for Jane to give remarks for PROP,” Kolodny wrote in an email of his own. “You don’t need to include a full written statement, just mention that you intend to speak in favor of the draft guideline and the need for promoting more cautious opioid use.”

Although the public notice asked that “each organization register one speaker to represent their organization,” PROP wound up having four speakers at the Jan. 28 hearing: Kolodny, Ballantyne, Franklin and Dr. David Juurlink. Franklin registered on Jan. 8, identifying himself as a representative of “Washington State public agencies.” Juurlink signed up as a representative of the “University of Toronto and American College of Medical Toxicology” and Kolodny identified himself as “Chief Medical Officer, Phoenix House Foundation.” Only Ballantyne signed up as representative of PROP.

The four PROP members were joined by over two dozen other guideline supporters, including Gary Mendell, Judy Rummler, Pete Jackson and other anti-opioid activists who have lost children to opioid overdoses. They urged CDC not to change the guideline by “watering it down” or removing dose limits.  

“The CDC guideline is urgently needed. The guideline was very carefully crafted using the best available evidence, expert opinion from a group of individuals with extensive experience of writing practice guidelines, and stakeholder input from a broad and balanced group of stakeholders,” Ballantyne said in her written comments.

“Primary care needs guidance on opioid prescribing that is free of industry bias. The CDC guideline accomplishes this. Evidence shows that the widespread use of opioids for chronic pain is harming more people than it is helping,” said Kolodny, according to minutes of the hearing.

Only four people spoke in opposition to the guideline. One was Howard Techau, a pain patient who pointed out that most overdoses were caused by illicit fentanyl, not pain medication. “Many chronic pain patients are suffering more now due to the (opioid) restrictions that are already in place,” said Techau, according to the hearing minutes.

The hearing ended with BSC chair Dr. Stephen Hargarten thanking the participants for their “extraordinary discussion and input from a variety of perspectives.”

‘Stacking the Deck’

A pain patient who registered for the hearing but was not given a chance to speak was Anne Fuqua. She encouraged dozens of other patients to attend and register as speakers, helping some to fill out their online registration forms. When the hearing ended and none of them were called upon to speak, she remembers feeling the hearing was rigged and stacked against patients

“The whole process felt like such a concerted effort to railroad patients,” Fuqua told PNN. “I remember at the time us saying we felt like it was beyond the realm of chance that they randomly selected the speakers.

“Aside from the 4 PROPers, it just doesn’t seem possible that supporters would have been this successful in flooding the sign-in ahead of everyone else.”

The CDC disputes the notion that anyone at the hearing who was pre-registered was denied an opportunity to speak.

“A total of 37 individuals pre-registered for the meeting and, of those, 30 requested to give oral public comment.  During the 90 minutes allotted for public comment, participants were called on in the order that they registered.  After individuals that had pre-registered were given the opportunity for public comment, public comment was opened to others for the remaining time. One additional person provided public comment at that time,” Courtney Leland, a CDC spokesperson, said in a statement to PNN.

“I don’t understand how they could possibly say only 30 registered to provide public comments. There were so many patients who told me they registered at the time and I registered way more than 30 people myself,” says Fuqua, who provided dozens of donated cell phones to nursing home residents so they could call in.

Others questioned the “first come, first served” process used by CDC to sign-up speakers, which could be easily manipulated by anyone given advance notice.

“The first come-first served method necessarily gives advantages to groups that hire lobbyists to track Federal Register postings, and, apparently, groups that have an inside connection who can alert them to the opportunity,” said Bob Twillman, PhD, former Executive Director of the American Academy of Pain Management. “Individual patients and even patient advocacy organizations are not going to have the resources to find out about these opportunities until the very limited number of slots are filled. CDC needs to seriously re-think this method of filling spots if they do anything like this in the future.”

‘Forward This Announcement to Others’

At least five PROP board members were involved in advising the CDC during the guideline’s development, so it is not clear why they were given yet another chance to express their opinions. Ballantyne and Franklin were members of a key guideline advisory panel known as the Core Expert Group; Dr. David Tauben was on the guideline’s peer review panel; and Kolodny and Juurlink were on a stakeholder review group.

Kolodny has tried to downplay PROP’s role in drafting the opioid guideline, but Chou’s email is direct evidence that there was some degree of collusion.

When asked why he contacted PROP and other organizations to give them an early heads-up about the hearing, Chou said he did so at the request of the CDC. A CDC staffer emailed Chou and other “Partners” involved in the guideline process, urging them to “forward this announcement to others who may be interested in commenting.”

“The information I forwarded to those folks and others was from an email that I received from CDC on January 8 that had been sent out widely to partners/stakeholders. Not sure why there would be any prohibition on sharing that information, which was public,” Chou wrote in an email to PNN.

But the information was not yet public, at least not widely. CDC never sent out a press release about the hearing and the public notice that was in the Federal Register probably wasn’t seen by many people outside of lobbyists.      

“Chou can say all he wants that this justified his efforts to stack the deck, but it also shows CDC was complicit,” says Fuqua.

“The fact that CDC would encourage people to publicize the availability of this speaking opportunity prior to publication in the Federal Register, especially when they were using a first come-first served selection method, is problematic,” said Twillman. 

“It is shameless that Roger Chou gave PROP a head start to prepare. It’s like an author writing their own book reviews,” said Julie Killingworth, a pain patient and independent researcher who helped PNN track the 2016 emails, which were obtained by another journalist through the Freedom of Information Act.  

“PROP members and their cohorts like Chou have proven beyond doubt they will always resort to cheating and lying to promote and profiteer their destructive scientifically faulty agenda. The CDC has unapologetically shacked up with a shadowy lobbying group, endangering the health and well-being of all citizens.”  

As for Chou’s warning that pharma was “gearing up to take as many slots as they can” at the hearing -- not a single representative from the pharmaceutical industry spoke. Pharma did not “dominate” the hearing as Chou predicted, PROP and other guideline supporters did.

Outspoken Critic of Opioids

All of this happened six years ago and may seem like “inside baseball” trivia to people unfamiliar with the CDC and its opioid guideline. But for this reporter and others who have followed the issue for years, it has a familiar ring.

Chou is a prolific researcher who heads the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University, which over the last five years has received over two billion dollars in research grants from the federal government, much of it spent studying pain management therapies.

Most public health researchers keep a low profile to avoid accusations of bias, but Chou has long been an outspoken critic of opioid prescribing. In a 2019 podcast, for example, Chou said the benefits of opioids were “clinically insignificant” and that the medications are often harmful.

Chou has also collaborated on several prior occasions with PROP. In 2019, he co-authored an op/ed with Ballantyne and PROP board member Dr. Anna Lembke that encourages doctors to consider tapering “every patient receiving long term opioid therapy.”

DR. ROGER CHOU

In 2011, Chou wrote another op/ed with Kolodny and Von Korff, calling for a major overhaul of opioid prescribing guidelines, which were then mostly developed by pain management societies. That major overhaul came in 2016, when the CDC released its own guideline, which was quickly adopted by many states, insurers, physician groups and even law enforcement agencies.

Opioid prescribing fell dramatically as a result, yet drug overdoses rose to record levels, and many pain patients were tapered off opioids or abandoned by doctors who feared prosecution for prescribing the medications. Patients who once led productive lives while on opioids became unable to work, disabled and bedridden. Even the CDC admits the guideline has been harmful to patients and is in need of overhaul.    

Patients may be suffering and overdoses keep rising, yet several members of PROP have done well for themselves. At least six PROP board members have worked for plaintiff law firms involved in opioid litigation, making as much as $850 an hour. Kolodny, by his own admission, was paid up to $500,000 for testifying in one trial.

‘Compromised by Conflicts’

To this day, Chou remains heavily involved with the CDC. He is one of five co-authors drafting a revised and more “flexible” version of the guideline, which is expected for release later this year. He is also now a member of the CDC’s Board of Scientific Counselors. Critics say Chou’s biases and conflicts of interest are excessive and he should be removed from both roles.

“Based on growing evidence from our own research and many credible sources, the CDC inappropriately collaborated with Chou and leaders from the advocacy group PROP, to create and vigorously promote unfocused reductions in opioid prescribing,” says Dr. Chad Kollas, a palliative care physician who co-authored research critical of Chou’s “undisclosed” conflicts and PROP's role in helping to draft the guideline.

“The creation process for the 2016 Guideline lacked transparency and repeatedly violated CDC’s internal rules and policies addressing relevant conflicts of interest, thereby compromising its scientific integrity and its authors’ credibility. While the draft of CDC’s 2022 Clinical Practice Guideline on Prescribing Opioids for Pain seeks to mitigate growing patient harms from the 2016 Guideline, it is difficult to understand why CDC continued to allow Chou, compromised by ongoing conflicts of interest, to lead its effort to improve its failed opioid policy.”

Distrust of the CDC runs deep in the pain community. In a PNN survey of over 2,500 patients, providers and caregivers earlier this year, nearly 96% said they do not trust the agency to handle the revision of the guideline in an unbiased and scientific manner.

This week, an open letter signed by over 35,000 people was delivered by patient advocate Tamera Stewart to the office of Chris Jones, Acting Director of the CDC’s National Center for Injury Prevention and Control. The letter says the 2016 guideline is so deeply flawed and compromised by ethical violations that it should be completely withdrawn and revoked, without any revisions.

Stewart, who is Policy Director for the P3 Alliance, is also asking Congress to investigate the CDC’s alleged violations of federal procedure and scientific methods during the development of the original and revised versions of the guideline.

CDC Director Dr. Rochelle Walensky recently announced plans to reorganize the agency due to mistakes made during its handling of the Covid pandemic, with the goal of improving communication with the public and changing CDC culture. Walensky put three senior CDC officials in charge of a “top-to-bottom review” of the agency.

One of them is Acting Deputy Director Dr. Deb Houry, the former director of the National Center for Injury Prevention and Control, who oversaw the drafting and rollout of the 2016 guideline. Houry will likely be reviewing the work of Dr. Deborah Dowell, who was chief medical officer for the CDC’s Covid Response team. Houry is already very familiar with Dowell, who co-authored both the 2016 guideline and the revised guideline that is awaiting release.  

Medical Gaslighting of Woman for Being of 'Childbearing Age' Goes Viral

By Madora Pennington, PNN Columnist

After seeing a neurologist earlier this month for cluster headaches, Tara Rule’s doctor walked her to the front desk. She thanked him. Then, in her car, she burst into tears. Instead of treating her pain, the doctor turned the appointment into a lecture about a hypothetical pregnancy that she didn't want. He had made her feel so horrible, she wanted to die.

“I can’t keep living in world where it is a game to them,” she said to herself.

Feeling hopeless and alone, Rule pulled out her cellphone and, tears streaming down her face, recorded a video recounting what had just happened and how she felt about it.

It is rare to actually see the raw, visceral reaction to medical gaslighting, and how it affects someone’s self-worth and mental health. Many patients leave such appointments doubting themselves, often becoming unwilling to seek medical care as the medical traumas add up.

Rule, 31, is already on disability from a lifetime of complex medical problems, including Ehlers-Danlos Syndrome (EDS), a connective tissue disorder.

When she realized her appointment at a Glen Falls, New York hospital was going sideways, she reached into her bag and began an audio recording with her cellphone. New York allows single party consent to recording, so she didn't need to have the doctor’s permission.

Rule was trying to keep it together, despite her intense pain from debilitating headaches. She wanted the recording so she could sort out what happened later. She wanted to make sure her PTSD from past medical trauma was not triggering her, possibly causing her to misunderstand the doctor.

TARA RULE

In the recording, Rule’s neurologist said he would not give her a certain medication to treat her headache. His reason? She could get pregnant and that particular drug — which he did not name — can cause birth defects. So he doesn't prescribe it to women of "childbearing age."

Rule pushed back, pointing out she is already on a medication for an autoimmune condition that can cause birth defects and miscarriages. And because EDS is a genetic disorder, she does not want to have a child and risk passing it on. Plus, a pregnancy could be harmful for her health.

Instead of making the appointment about Rule's pain and her need for treatment, she says the doctor asked her intrusive questions about her sex life. He disregarded the medical information she provided and patronizingly suggested she might change her mind if she were pregnant. He also insisted her sexual partner would have to consent to her being treated with the unnamed drug.

Rule posted her anguished video on TikTok, and it soon went viral. She's received countless messages from others who have been through similar encounters. While it made her feel less alone, it saddened Rule deeply to learn how many people have stories like hers. The media took notice with articles on Jezebel and in the Albany Times Union.

Severe headaches and cranio-cervical pain are commonly seen in people with EDS, an inherited failure of the body to produce strong collagen. Rule has suffered from migraines since she got a concussion at age eight. Her cluster headaches started in 2016.

“They are a whole different beast,” she told me. “The pain is indescribable. It doesn’t let up. It won’t go away.” Rule says she is a happy person who is not suicidal, but pain like that makes you wish you weren’t alive.

Rather than treat the suffering patient in front of him, the neurologist prioritized a hypothetical situation, in which Rule's birth control fails and she winds up pregnant. For him, this fantasy scenario was more important than giving her the best medical option for pain relief.

Rule complained to the hospital, which apologized and began an investigation. She also created a petition to end doctors' ability to deny treatment to women because they might get pregnant. So far, over 25,000 people have signed it, making it one of the most popular petitions on Change.org.

“As a living, breathing human being who exists, I feel it is absurd that doctors who are expected to provide the best, most effective care and treatments to their patients are able to deny effective treatments due to the potential for birth defects in patients of child bearing age who are not currently pregnant,” she wrote in the petition. 

The week after her botched meeting with the neurologist, Rule found herself in throes of horrendous head pain and took herself to urgent care. She was receiving an IV and oxygen when a group of doctors and security personnel marched into her room. She panicked, thinking of when she was told she had lesions on her brain. Were these people coming to give her bad news like that?

No, the staff was not here to provide medical services. They had come to discharge her. The hospital Rule had complained to apparently called other clinics in the area about her. The urgent care personnel accused her of livestreaming the appointment with her neurologist, which she did not. Nonetheless, they wanted her out immediately. She tried to give the desk her new insurance information as she left, but the staff had closed the window and simply stared at her.

“Shouldn’t they be putting that doctor on leave rather than track my social media and call hospitals? It’s scary,” she told PNN.

Now Rule is afraid to seek medical care. Most of the facilities in her area are owned by that hospital system. Her primary care doctor is part of it. She is not sure if any of them will see her.

“I’m on disability. I have no money. Am I going to have to move?” she wonders.

Madora Pennington is the author of the blog LessFlexible.com about her life with Ehlers-Danlos Syndrome. She graduated from UC Berkeley with minors in Journalism and Disability Studies.