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. 

My Story: Hospitals Are Undertreating Pain

By Michael Swift, Guest Columnist

Right now, as I type this, I can barely finish because I just got home from a surgery in my abdominal area. I won't get into the details, but a lot of cutting was done, and I was discharged after an agonizing hospital stay. I was given Tylenol and Naproxen for post-surgical pain.

I am now reclined in bed at home and suffering from post-op pain because a major hospital in a city of a quarter million people is undertreating pain. This is the new norm for most hospitals here in Texas.

My wife and I lived in beautiful central Oregon all our lives. We ended up vacating the house we rented and could find no place to live in the entire state that was affordable to us. For family reasons, we moved to the Texas Panhandle.

My wife, seeking a new pain specialist in Amarillo, was denied and bawled-out two times by doctors. She was told by one verbatim: “We don't push dope here. If you want drugs, go to the north side of town."

I almost walked back in after she told me what this doctor had said to her, to punch him in the mouth. But it would do no good trying to help her from a jail cell. She was visibly upset, in tears, humiliated and so hurt. She is a 67-year-old senior with spinal stenosis and a bone disease that is destroying her vertebral column. Even with stellar remarks by her former providers as a "model patient with legitimate pain,” she was still an object for these millennial brats to verbally spit upon.

When living back in Oregon, my wife and I had a wonderful provider in Bend and our lives were fully active. We failed however to do our homework before moving to Texas. When we arrived, we realized that the Texas Medical Board and certain medical groups and doctors decided they wanted to solve the huge drug abuse problem.

The real problem here has been massive amounts of illicit fentanyl, comprising about 75% of overdose deaths, along with heroin, ecstasy and many other street drugs pushed in by the Sinaloa drug cartel. Nevertheless, the medical board went after the doctors and patients because it was easier than addressing the real problem.

A Broken Healthcare System

To say the least, I am saddened, upset and feeling a huge weight of condemnation from individuals here in the medical field. What a broken and detached healthcare system.

We are both leaving Texas for a nearby state, already set up with a new provider there, who is willing to take a good look at her without judgement. I am not leaving though, until I file a complaint against both pain management providers for their unethical, cruel treatment and libelous slander -- with the use of profanity to my wife's face -- all confirmed by the nurse in the exam room.

I will also file a complaint with the Texas Medical Board for the experience I had as a surgery patient. It will fall on deaf ears, but I won't stop until I get a response. To those of you out there who are also suffering and abandoned, take any and EVERY measure available to control your pain, which is robbing you of your life. You have no other choice.

There is a terrible and frightening experience awaiting those who are destined to go under the knife in hospitals that have overreacted to the "opioid crisis” by implementing a new policy of completely abstaining from administering any narcotic pain medication to post-surgical patients.

I suppose I could have screamed at the top of my lungs to demand pain relief, but who wants that on their record. Or worse, to be blacklisted. Thank God I have an alternate source of pain relief, but I am still astounded.

I am a veteran of nine prior surgeries, all of them done over 20 years ago. When I was in the hospital after those surgeries, I was asked by a nurse what narcotic I wanted to choose for pain relief. After that, I stayed healthy, avoided more surgeries and interpreted the many stories I heard about "Tylenol for post-op pain" as nothing but false tales and fear-mongering.

To all and any of you who posted such statements, I sincerely apologize. You were telling the truth.

Michael Swift lives with degenerative disc disease, arthritis and severe migraines.

Do you have a “My Story” to share? Pain News Network invites other readers to share their experiences about living with pain and treating it.

Send your stories to editor@painnewsnetwork.org

Gabapentin Raises Risk of Delirium in Older Surgery Patients

By Pat Anson, PNN Editor

It’s become trendy in recent years for U.S. hospitals to use gabapentin (Neurontin) as a “safer” alternative to opioids for post-operative pain.  But a large new study has found that gabapentin increases the risk of delirium and other adverse health effects in older patients recovering from surgery.

The study, published in JAMA Internal Medicine, looked at nearly a million patients over the age of 65 who had major surgical procedures, including cardiac, orthopedic and gastrointestinal surgeries. About 12% of the patients received gabapentin and other analgesics for perioperative pain management between the day of surgery and two days after surgery.

Researchers found that gabapentin “modestly increased” the risk of delirium, a mental state in which a person becomes confused, disoriented and unable to think or remember clearly. Patients who received gabapentin were also more likely to be prescribed antidepressants and other anti-psychotic drugs, and to develop pneumonia.

“Considering the increasing number of major surgeries performed in older adults, and the negative consequences of perioperative delirium, our findings raise concern about an increasingly adopted clinical practice that involves routine use of gabapentin as part of multimodal analgesia,” wrote lead author Dae Hyun Kim, MD, a geriatrician and epidemiologist at Brigham and Women's Hospital and Assistant Professor of Medicine at Harvard Medical School.

“On the basis of these findings and those of meta-analyses of RCTs (randomized controlled trials) showing a weak opioid-sparing effect of gabapentin, clinicians should reconsider routine use of gabapentin for perioperative pain management among older adults and individualize the treatment decision after assessing the risk of immediate harms vs opioid-sparing benefits of perioperative gabapentin use.”

‘Windfall Medication’

Although gabapentin is an anti-convulsant that was originally developed to treat epilepsy, it is increasingly prescribed “off-label” to treat various types of pain. In 2016, the American Pain Society recommended that gabapentin be used “around the clock” for post-operative pain because it lowered pain scores and reduced the use of opioids. But studies later found the drug was ineffective for post-operative pain and actually increased the risk of an overdose.

An editorial published in JAMA Internal Medicine said the new study demonstrates that the risks of gabapentin outweigh its potential benefits in older patients.

“These results are consistent with what is now a growing body of literature suggesting that gabapentin may not be the windfall medication for perioperative pain management that surgeons hoped it might be for decreasing opioid use. The adverse events reported in this study (delirium, antipsychotic use, and pneumonia) add to similar findings that gabapentin, especially when used concomitantly with opioids, increases the risk of postoperative sedation and dizziness,” wrote lead author Zachary Marcum, PharmD, University of Washington School of Pharmacy.  

“As the use of gabapentin continues to rise, it is critically important clinicians understand its risks, especially for older adults. Poorly controlled postoperative pain is associated with several complications, including cognitive impairment, delirium, depression, decreased mobility, and longer recovery.”

It’s a common misconception that patients often become addicted to opioids after surgery. A 2016 Canadian study found that long term opioid use after surgery is rare, with only 0.4% of older adults still taking opioids a year after major elective surgery. A 2018 study at Harvard Medical School had similar findings. Only 0.6% of patients who were prescribed opioids for post-operative pain were later diagnosed with opioid dependence, abuse or a non-fatal overdose.

Supreme Court Ruling Gives Hope to Doctors Facing Opioid Charges

By Brett Kelman, Kaiser Health News

Dr. Nelson Onaro conceded last summer that he’d written prescriptions illegally, although he said he was thinking only of his patients. From a tiny, brick clinic in Oklahoma, he doled out hundreds of opioid pills and dozens of fentanyl patches in a way that was "outside the usual course of professional practice."

“Those medications were prescribed to help my patients, from my own point of view,” Onaro said in court, as he reluctantly pleaded guilty to six counts of drug dealing. Because he confessed, the doctor was likely to get a reduced sentence of three years or less in prison.

But Onaro changed his mind in July. In the days before his sentencing, he asked a federal judge to throw out his plea deal, sending his case toward a trial. For a chance at exoneration, he’d face four times the charges and the possibility of a harsher sentence.

Why take the risk? A Supreme Court ruling has raised the bar to convict in a case like Onaro’s. In a June decision, the court said prosecutors must not only prove a prescription was not medically justified ― possibly because it was too large or dangerous, or simply unnecessary ― but also that the prescriber knew as much.

Suddenly, Onaro’s state of mind carries more weight in court. Prosecutors have not opposed the doctor withdrawing his plea to most of his charges, conceding in a court filing that he faces “a different legal calculus” after the Supreme Court decision.

The court’s unanimous ruling complicates the Department of Justice’s ongoing efforts to hold prescribers criminally liable for fueling the opioid crisis. Previously, lower courts had not considered a prescriber’s intention. Until now, doctors on trial largely could not defend themselves by arguing they were acting in good faith when they wrote bad prescriptions. Now they can, attorneys say, although it is not necessarily a get-out-of-jail-free card.

“Essentially, the doctors were handcuffed,” said Zach Enlow, Onaro’s attorney. “Now they can take off their handcuffs. But it doesn’t mean they are going to win the fight.”

The Supreme Court’s decision in Ruan v. United States, issued June 27, was overshadowed by the nation-shaking controversy ignited three days earlier, when the court erased federal abortion rights. But the lesser-known ruling is now quietly percolating through federal courthouses, where it has emboldened defendants in opioid prescribing cases and may have a chilling effect on future prosecutions of doctors under the Controlled Substances Act.

In the three months since it was issued, the Ruan decision has been invoked in at least 15 ongoing prosecutions across 10 states, according to a KHN review of federal court records. Doctors cited the decision in post-conviction appeals, motions for acquittals, new trials, plea reversals, and a failed attempt to exclude the testimony of a prescribing expert, arguing their opinion was now irrelevant. Other defendants have successfully petitioned to delay their cases so the Ruan decision could be folded into their arguments at upcoming trials or sentencing hearings.

David Rivera, a former Obama-era U.S. attorney who once led prescribing prosecutions in Middle Tennessee, said he believes doctors have a “great chance” of overturning convictions if they were prohibited from arguing a good faith defense or a jury was instructed to ignore one.

Rivera said defendants who ran true pill mills would still be convicted, even if a second trial was ultimately required. But the Supreme Court has extended a “lifeline” to a narrow group of defendants who “dispensed with their heart, not their mind,” he said.

“What the Supreme Court is trying to do is divide between a bad doctor and a person who might have a license to practice medicine but is not acting as a doctor at all and is a drug dealer,” Rivera said. “A doctor who is acting under a sincerely held belief that he is doing the right thing, even if he may be horrible at his job and should not be trusted with human lives ― that’s still not criminal.”

The Ruan decision resulted from the appeals of two doctors, Xiulu Ruan and Shakeel Kahn, who were separately convicted of running pill mills in Alabama and Wyoming, respectively, then sentenced to 21 and 25 years in prison. In both cases, prosecutors relied on a common tactic to show the prescriptions were a crime: Expert witnesses reviewed the defendants’ prescriptions and testified that they were far out of line with what a reasonable doctor would do.

But in writing the opinion of the Supreme Court, then-Justice Stephen Breyer insisted the burden of proof should not be so simple to overcome, remanding both convictions back to the lower courts for reconsideration.

Because doctors are allowed and expected to distribute drugs, Breyer wrote, prosecutors must not only prove they wrote prescriptions with no medical purpose but also that they did so “knowingly or intentionally.” Otherwise, the courts risk punishing “conduct that lies close to, but on the permissible side of, the criminal line,” Breyer wrote.

To defense attorneys, the unanimous ruling sent an unambiguous message.

“This is a hyperpolarized time in America, and particularly on the court,” Enlow said. “And yet this was a 9-0 ruling saying that the mens rea ― or the mental state of the doctor ― it matters.”

Maybe nowhere was the Ruan decision more pressing than in the case of Dr. David Jankowski, a Michigan physician who was on trial when the burden of proof shifted beneath his feet.

Jankowski was convicted of federal drug and fraud crimes and faces 20 years in prison. In an announcement of the verdict, the DOJ said the doctor and his clinic supplied people with “no need for the drugs,” which were “sold on the streets to feed the addictions of opioid addicts.”

Defense attorney Anjali Prasad said the Ruan ruling dropped before jury deliberations in the case but after prosecutors spent weeks presenting the argument that Jankowski’s behavior was not that of a reasonable prescriber — a legal standard that on its own is no longer enough to convict.

Prasad cited the Ruan decision in a motion for a new trial, which was denied, and said she intends to use the decision as a basis for a forthcoming appeal. The attorney also said she is in discussion with two other clients about appealing their convictions with Ruan.

“My hope is that criminal defense attorneys like myself are more emboldened to take their cases to trial and that their clients are 100% ready to fight the feds, which is no easy task,” Prasad said. “We just duke it out in the courtroom. We can prevail that way.”

Some defendants are trying. So far, a few have scored small wins. And at least one suffered a crushing defeat.

In Tennessee, nurse practitioner Jeffrey Young, accused of trading opioids for sex and notoriety for a reality show pilot, successfully delayed his trial from May to November to account for the Ruan decision, arguing it would “drastically alter the landscape of the Government’s war on prescribers.”

Also in Tennessee, Samson Orusa, a doctor and pastor who last year was convicted of handing out opioid prescriptions without examining patients, filed a motion for a new trial based on the Ruan decision, then persuaded a reluctant judge to delay his sentencing for six months to consider it.

And in Ohio, Dr. Martin Escobar cited the Ruan ruling in an eleventh-hour effort to avoid prison.

Escobar in January pleaded guilty to 54 counts of distributing a controlled substance, including prescriptions that caused the deaths of two patients. After the Ruan decision, Escobar tried to withdraw his plea, saying he’d have gone to trial if he’d known prosecutors had to prove his intent.

One week later, on the day Escobar was set to be sentenced, a federal judge denied the motion. His guilty plea remained and Escobar got 25 years.

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

Opioid Prescriptions Down Sharply for Medicare Patients

By Pat Anson, PNN Editor

The number of Medicare beneficiaries receiving opioid prescriptions has declined significantly since 2016, according to a new government report that also found steep declines in the number of beneficiaries receiving high doses or who appear to be doctor shopping.

The report by the Department of Health and Human Service’s Office of Inspector General found that over 21 million people -- 23% of Medicare Part D beneficiaries -- received at least one opioid prescription in 2021, down from 33% of beneficiaries in 2016. Over 51 million people are currently enrolled in Part D.

The Centers for Medicare and Medicaid Services (CMS) adopted new safety rules in 2018 that discourage high dose prescribing and limit the initial supply of opioids to 7 days. The rules also allowed pharmacists and insurers to flag Medicare patients deemed to be at high risk, as well as their prescribers.

The rules appear to have had a major impact on prescribing. In 2016, over half a million Medicare beneficiaries received a daily opioid dose of at least 120 MED (morphine milligram equivalent). By 2021, that fell to less than 200,000 patients, a 60 percent decrease in high dose prescribing.   

MEDICARE PATIENTS RECEIVING HIGH DOSE OPIOIDS

HHS Office of Inspector General

Since 2016, the number of Medicare beneficiaries who appeared to be doctor shopping dropped from 22,300 to 1,800; while the number of doctors with “questionable” prescribing patterns fell from 401 to just 98.  Patients were flagged for doctor shopping if they were on high doses and received opioids from four or more prescribers or four or more pharmacists.

“The opioid epidemic continues to grip the nation. There is clearly still cause for concern and vigilance, even as some positive trends emerge,” the OIG report found. “The number of Medicare Part D beneficiaries who received opioids in 2021 decreased to approximately a quarter of a million beneficiaries, extending a downward trend from prior years. Further, fewer Part D beneficiaries were identified as receiving high amounts of opioids or at serious risk of misuse or overdose. The number of prescribers ordering opioids for large numbers of beneficiaries at serious risk was steady.”

But there is little evidence that less prescribing is reducing addiction and overdoses.  The Centers for Disease Control and Prevention estimates there were nearly 81,000 opioid-related deaths in 2021, nearly twice the number reported in 2016, when the CDC’s opioid guideline was released. The vast majority of deaths involved illicit fentanyl and other street drugs, not prescription opioids.

The OIG report found that 50,391 Part D beneficiaries experienced an opioid overdose (either fatal or non-fatal) in 2021, but did not break down how many were linked to illicit or prescription opioids.

Over one million Medicare beneficiaries were diagnosed with opioid use disorder (OUD) last year, but only one in five received a medication like Suboxone or methadone to treat their condition. Medicare patients were far more likely to receive naloxone, an overdose reversal drug. Over 445,000 beneficiaries received a prescription for naloxone, an 18% increase from 2020.

Older Adults Look Beyond Western Medicine for Help With Joint Pain

By Pat Anson, PNN Editor

Most older Americans use over-the-counter pain medication and exercise to manage their joint pain, according to a large new survey of adults over age 50. Marijuana, opioids and non-steroidal anti-inflammatory drugs (NSAIDs) were rated the most effective pain relievers among those who used them.

The survey of 2,277 adults aged 50 to 80 was conducted online and over the phone early this year as part of the University of Michigan’s National Poll on Healthy Aging. It found that many older adults looked beyond conventional Western medicine for help with their joint pain, but few talked to their doctors about it.

Eight out of ten people (80%) with joint pain said they were confident they could manage it on their own. The survey found that two-thirds (66%) used over-the-counter pain relievers such as NSAID’s or acetaminophen.

The vast majority (89%) also used non-pharmacologic treatments to manage their symptoms, including exercise (64%), massage (26%), physical therapy (24%), splints or braces (13%), and acupuncture or acupressure (5%).

One in four (26%) said they take supplements, such as glucosamine, chondroitin and turmeric, while 11% use cannabidiol (CBD) products and 9% use marijuana.

Only a minority use prescription-based treatments, such as non-opioid pain relievers (18%), steroid joint injections (19%), oral steroids (14%), opioids (14%) and disease-modifying anti-rheumatic drugs (4%).

NATIONAL POLL ON HEALTHY AGING

“There are sizable risks associated with many of these treatment options, especially when taken long-term or in combination with other drugs. Yet 60 percent of those taking two or more substances for their joint pain said their health care provider hadn’t talked with them about risks, or they couldn’t recall if they had,” said Beth Wallace, MD, Assistant Professor of Internal Medicine at Michigan Medicine and a staff rheumatologist at the VA Ann Arbor Healthcare System.

“This suggests a pressing need for providers to talk with their patients about how to manage their joint pain, and what interactions and long-term risks might arise if they use medications to do so.”

Both NSAIDs and oral steroids have health risks, especially for older adults. Chronic NSAID use can worsen medical conditions such as hypertension, kidney disease, gastrointestinal bleeding and cardiovascular disease. Short-term use of oral steroids is associated with similar problems, as well as increased risk of developing diabetes, cataracts, insomnia, depression, and anxiety.

The risks are even greater if NSAIDs and oral steroids are taken together. Despite this, about one in four older adults taking oral steroids for joint pain said they had not discussed the potential risks with their provider.

Joint pain is common among older adults, including those who have not been formally diagnosed with arthritis. Nearly half of those surveyed reported joint pain that limited their daily activities, but few rated their symptoms as severe and most regarded joint pain as a normal part of aging.

Those with severe joint pain were somewhat fatalistic about it, with nearly half (49%) agreeing with the statement that “there is nothing a person with arthritis or joint pain can do to make their symptoms better.” Only 10% of those with mild joint pain agreed there was nothing they could do about it.

“Older adults with fair or poor physical or mental health were much more likely to agree with the statement that there’s nothing that someone with joint pain can do to ease their symptoms, which we now know to be untrue. Health providers need to raise the topic of joint pain with their older patients, and help them make a plan for care that might work for them,” said poll director Preeti Malani, MD, a Michigan Medicine physician who specializes in geriatrics and infectious diseases.

Drug Tests Show Pain Patients on Opioids Less Likely to Use Illicit Drugs

By Pat Anson, PNN Editor

In an effort to reduce soaring rates of drug abuse and overdoses, many physicians have taken their pain patients off opioids and switched them to “safer” non-opioid drugs like pregabalin, gabapentin and duloxetine. Others have encouraged their patients to try non-pharmacological treatments, such as acupuncture, massage and meditation.

That strategy may be backfiring, according to a large new study by Millennium Health, which found that pain patients prescribed opioids are significantly less likely to use illicit drugs than pain patients not getting opioids.

The drug testing firm analyzed urine drug samples from 2019 to 2021 for nearly 55,000 patients being treated by U.S. pain management specialists. About 80% of the patients were prescribed an opioid like oxycodone or hydrocodone, while the other 20% were not prescribed opioids.

Millennium researchers say detectable levels of illicit fentanyl, heroin, methamphetamine and cocaine were far more likely to be found in the urine of non-opioid patients than those who were prescribed opioids. For example, illicit fentanyl was detected in 2.21% of the patients not getting an opioid, compared to 1.169% of those who were. The findings were similar for heroin, methamphetamine and cocaine.

“In all cases, we found that the population that was not prescribed an opioid was significantly more likely to be positive for an illicit drug than those patients who were prescribed opioids,” said lead author Penn Whitley, Director of Bioinformatics at Millennium. “(There was) a 40 to 60 percent increase in the likelihood of being positive if you were not prescribed an opioid.”

Illicit Drug Use By Pain Patients

MILLENNIUM HEALTH

What do the findings mean? Are pain patients getting ineffective non-opioid therapies so desperate for relief that they’re turning to illicit drugs? That’s possible, but the study doesn’t address that specifically.

Another possibility is that patients on opioids are simply being more cautious and careful about their drug use. Opioid prescribing in the U.S. has fallen by 48% over the past five years, with many patients being forcibly tapered or abandoned by doctors who feel pressured to reduce their prescribing.  

“Unfortunately, a lot of people with chronic pain have learned that it’s a bit tenuous, that their doctors are feeling pressure, and if they want to maintain their access (to opioids), they need their PDMP (Prescription Drug Monitoring Program) and their drug tests to look the way they need to look, so their doctor can feel comfortable continuing to prescribe,” said co-author Steven Passik, PhD, VP of Scientific Affairs and Head of Clinical Data Programs at Millennium. “I do think they realize that they’re on a treatment and that access to it is not guaranteed.”   

Preliminary findings from the study were released today at PainWeek, an annual conference for pain management providers. The findings mirror those from another Millennium study earlier this year, which found that pain patients have lower rates of illicit drug use than patients being treated by other providers.     

“If your main way of protecting people in pain from getting involved in substance abuse is to limit their access to opioids, there’s at least a hint here that’s not the right approach,” Passik told PNN. “It’s not a definitive statement by any stretch of the imagination, but it’s an approach to patient safety that leaves a bit to be desired.”  

Another recent study at the University of Texas also found that restricting access to opioids is “not a panacea” and may even lead to more overdoses.  Researchers found that in states that mandated PDMP use, opioid prescribing decreased as intended, but heroin overdose deaths rose 50 percent.

“Past research has shown that when facing restricted access to addictive substances, individuals simply seek out alternatives rather than limiting consumption,” said lead author Tongil Kim, PhD, an assistant professor of marketing at University of Texas at Dallas. “In our case, we measured overdose deaths as a proxy and found a substantial increase, suggesting that the policy unintentionally spurred greater substitution.”

DEA Warns of ‘Rainbow Fentanyl’ Targeting Kids

By Pat Anson, PNN Editor

At first glance, they look like candy. Brightly-colored tablets in shades of pink, purple, yellow and green. Not unlike a bag of Skittles or a bowl of Fruit Loops.

But they’re not sweet treats. They’re the latest version of “Mexican Oxy” – counterfeit oxycodone pills laced with fentanyl, stamped with an “M” on one side and “30” on the other. Typically blue in color – like authentic oxycodone – the pills increasingly come in a variety of colors, what law enforcement agencies call “rainbow fentanyl.”

In recent weeks, rainbow fentanyl has been found in 18 states, including an August 17 bust at the Arizona border with Mexico, where over 15,000 of the colorful pills were found strapped to a smuggler’s leg.

It was the second consecutive day rainbow fentanyl was intercepted at the port of Nogales, a possible sign that drug cartels are targeting younger users.

“Rainbow fentanyl — fentanyl pills and powder that come in a variety of bright colors, shapes, and sizes — is a deliberate effort by drug traffickers to drive addiction amongst kids and young adults,” DEA Administrator Anne Milgram said in a statement that warns of the “alarming emerging trend.”

HOMELAND SECURITY IMAGE

The DEA says rainbow fentanyl is being seized in multiple forms, including blocks that resemble the chalk a child might use to color a sidewalk. A recent drug raid in Portland, Oregon turned up several powdered blocks of rainbow fentanyl, along with meth, heroin, hundreds of fentanyl pills and a small armory of guns.

“Deputies are particularly concerned about rainbow fentanyl getting into the hands of young adults or children, who mistake the drug for something else, such as candy or a toy, or those who may be willing to try the drug due to its playful coloring. The powdered fentanyl found during this investigation resembles the color and consistency of sidewalk chalk,” the Multnomah County Sheriff’s Office said in a statement.

“We are seeing more powdered fentanyl that is dyed in various colors. The strength can vary but is typically stronger than pressed pills,” said Kelsi Junge, Harm Reduction Supervisor for Multnomah County.

Some colors are believed to be more potent than others, a claim that has not been confirmed by DEA laboratory tests.  

No matter the color or shape, rainbow fentanyl is dangerous. Fentanyl is a synthetic opioid that is 50 times more potent than heroin and 100 times more potent than morphine. Just two milligrams of fentanyl, similar in size to 10-15 grains of salt, is considered a lethal dose. 

Because illicit fentanyl is cooked up in makeshift laboratories by amateur chemists, the potency of the pills or powder varies considerably.

MULTNOMAH COUNTY SHERIFF

The DEA says most of the illicit fentanyl in the United States is supplied by two Mexican drug cartels, the Sinaloa and Jalisco New Generation cartels, although there is no shortage of Americans willing to transport the drugs or turn them into tablets with pill presses.

“The men and women of the DEA are relentlessly working to stop the trafficking of rainbow fentanyl and defeat the Mexican drug cartels that are responsible for the vast majority of the fentanyl that is being trafficked in the United States,” said Milgram.

Fentanyl is a potent analgesic that is prescribed legally for severe pain, but it is illicit fentanyl and its analogues that are responsible for the vast majority of drug deaths. According to the CDC, over 107,000 Americans died of drug overdoses in 2021, with two-thirds of the deaths linked to fentanyl.

FDA Conducting Review of Opioid Regulations

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has launched an extensive review of its opioid regulations, with the goal of reducing overdoses and making revisions “to support appropriate use of opioid analgesics.”

In a blog post, FDA commissioner Robert Califf, MD, acknowledged the overdose crisis has “evolved beyond prescription opioids” and is now largely driven by illicit fentanyl and other street drugs. But he was vague about whether FDA would loosen restrictions on opioid pain medication or tighten them further.

“While the FDA’s previous strategies have largely focused on opioid use and overdoses, the evolving nature of the overdose crisis calls for both a new approach and honest reflection about what the FDA can do differently moving forward,” Califf said. “For example, during my confirmation process, I committed to undertaking a review of our opioid decisions, including labeling. We have initiated this review with the intended goal of understanding what revisions are needed to support appropriate use of opioid analgesics. Our ‘lessons learned’ will actively inform our future approach.”

One of the lessons learned by the CDC over the past few years is that rigid opioid prescribing guidelines have been harmful to patients and need to be “individualized and flexible.” The agency is currently in the process of revising its 2016 opioid guideline, with the goal of releasing an updated guideline late this year.

It’s not clear if the FDA is moving in a similar direction. One of the priorities for the agency’s new Overdose Prevention Framework is to “improve pain management and patient outcomes” – not by making opioids more accessible, but by reducing “unnecessary initial prescription drug exposure and inappropriate prolonged prescribing.” 

Califf said the agency was studying the need for mandatory prescriber education about opioids, including a national continuing education program about the use of opioids to manage pain. Most medical schools in the U.S. and Canada do not require a course in pain education and few even offer pain management as an elective.

The FDA may also tighten the rules for getting new opioids approved, including a requirement that drug makers demonstrate that their products offer material safety advantages over existing opioid analgesics. At the same time, the agency is planning to release new guidance to speed up the development of non-opioid and non-addictive treatments for chronic pain.

This is the 70-year old Califf’s second stint as FDA commissioner, having previously served in that role during the Obama administration. He was confirmed for a second time by the U.S. Senate last December by a narrow 50 to 46 vote. At the time, he promised an extensive review of the FDA’s opioid regulations to counteract complaints that the agency did little to prevent opioid misuse and was too accommodating to drug makers.

Federal efforts to reduce drug overdoses by limiting opioid prescriptions have largely failed. While opioid prescribing has fallen by 48% over the past five years, overdoses soared to a record 107,000 drug deaths in 2021, driven primarily by illicit fentanyl.

A recent study found no “direct correlation” between opioid prescribing and overdoses. Another analysis of overdose deaths in 2020 found that prescription opioids ranked well behind illicit fentanyl, alcohol, cocaine, methamphetamine and heroin as the leading cause of drug deaths.   

Raising Lazarus: Another Take on the Opioid Crisis

By Pat Anson, PNN Editor

Beth Macy’s bestselling book “Dopesick” – and the Hulu series based on it -- helped shape the popular narrative on the origins of the opioid crisis: that Purdue Pharma and the Sackler family duped physicians into prescribing highly addictive OxyContin to millions of pain patients, setting off a public health and overdose crisis that continues to this day.

Macy’s new book “Raising Lazarus” focuses on many of the same themes, but with an important new addition. She recognizes that opioid hysteria and fear of addiction went too far, depriving many people in pain of the medications they need to lead functional and productive lives.

“In recent years, law enforcement agencies, the CDC, and other medical authorities had overreacted to the first wave of the opioid crisis by clamping down too hard on opioid-prescribing,” Macy wrote. “Some doctors responded to the revised 2016 CDC opioid-prescribing guideline – and their fear of DEA prosecution – by declaring draconian caps and essentially abandoning their patients.

“People who needed opioids were refused access. Others with decades-long chronic conditions like extreme rheumatoid arthritis were abandoned by doctors and were now left bedbound. Some who were denied the opioids they’d been taking for decades attempted suicide or resorted to illegal drugs.”  

Those are welcome words from a noted critic of opioid “overprescribing.” But that passage – which is buried halfway through a 373-page book – doesn’t represent what Raising Lazarus is all about. Macy’s new book primarily deals with Purdue’s corporate greed and the ongoing struggles of working-class people in Appalachia to overcome addiction and a healthcare system that simply doesn’t work for them.

Macy is a bit defensive and resorts to gaslighting when she acknowledges past criticism from pain patients for Dopesick “drawing too much attention to overprescribed opioid pills.” Many of their complaints are valid, she admits, “if sometimes over-the-top and oblivious to the root causes of the crisis.”

Interestingly, Macy never actually quotes one of those “over-the-top” pain patients in Raising Lazarus, but she did interview Stanford pain psychologist Dr. Beth Darnall about the reluctance of doctors to prescribe opioids.

“Doctors are so concerned about being flagged, concerned about their license and their livelihood, they don’t want to take (chronic pain patients) on, and so you end up with patient abandonment, and iatrogenic harms that can create a medically dangerous situation,” Darnall told Macy.    

‘The Cruel World of Purdue Pharma’

Greed, no doubt, is one of the primary causes of the opioid crisis and Macy describes in detail how the Sacklers manipulated the political and legal system, paying their chief counsel the handsome rate of $1,790 an hour to gum things up as best he could to preserve the family fortune and prevent them from going to prison.

But she gives a free pass to others who have profited from the opioid crisis, often at the expense of pain patients, most notably the private plaintiff law firms suing drug makers on behalf of cities, counties and states.

Macy credits the late attorney Paul Hanly as being “the first to crack open the cruel world of Purdue Pharma” without pointing out that his law firm, Simmons Hanly Conroy, boasts that it “effectively invented large-scale, multi-defendant opioid litigation” and stands to make billions of dollars in contingency fees from settlement money.  

Also unmentioned is the $400,000 in campaign donations given by Simmons Hanly Conroy to former Sen. Claire McCaskill (D-MO) in 2018, who conveniently produced a well-publicized report that year critical of drug makers and medical pain societies that the law firm was suing. Overwhelmed with legal fees defending themselves, two of those pain societies filed for bankruptcy, a loss that pain management specialists, researchers and patients could ill afford.

Macy does quote anti-opioid activists like Dr. Andrew Kolodny and Dr. Anna Lembke, but doesn’t mention that they testified as paid expert witnesses for Hanly and other plaintiff law firms, making well into six figures for their testimony, which they often failed to disclose in conflict of interest statements.  

“The opioid-litigation money is a once-in-a-generation opportunity,” Macy writes, with unintended irony.

Macy is hopeful the settlement money – once estimated at $50 billion -- will go towards addiction treatment and better healthcare for communities ravaged by the opioid crisis. Unfortunately, much of it has already been spent on legal fees, media and public relations campaigns, and political donations. That’s not counting shady industries that have grown and prospered due to the opioid crisis; from drug testing and stem cell providers to cannabis promoters and drug cartels.  

Even though fentanyl and other street drugs are responsible for the vast majority of overdoses, Macy still clings to the tired notion that opioid pain medication started it all.

“A quarter century into the crisis, many people with OUD (opioid use disorder) have long since transitioned from painkillers to heroin, methamphetamine, and fentanyl, the ultra-potent synthetic opioid. And we now have a generation of drug users that started with heroin and fentanyl,” she writes. “Death by drugs is now a national problem, but the crisis began as an epidemic of overprescribed painkillers in the distressed communities that were least likely to muster the resources to fight back.”

I look forward to Macy’s next book and hope that she hears more from the distressed community of pain patients. They need a champion to fight for them too, not more gaslighting.