Study Raises Questions About Use of Opioids by Cancer Patients

By Pat Anson, PNN Editor

A new study led by researchers in Australia is raising questions about the effectiveness of prescription opioids in treating cancer pain, saying the evidence from clinical trials is inconclusive or “largely lacking.”

Opioids are a common treatment for cancer pain and are often considered indispensable, particularly near the end of life or in palliative care when pain can be most severe. Virtually all medical guidelines – including the CDC’s – specifically exempt cancer patients from any recommended limits on opioids.

But the new study, published in A Cancer Journal for Clinicians, rejects that long-held medical practice, suggesting that opioids work no better than a placebo in relieving cancer pain and that non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin may be just as good or better.

The study examined findings from over 150 clinical trials involving opioids and cancer, and found that most were not blinded or placebo-controlled. That’s a recurring issue in pain research due to the ethical issues involved in giving patients an ineffective or non-existent analgesic, particularly if they have a terminal illness. Although that shortcoming is widely understood and accepted – the authors of this new study view it as lack of evidence.

“Opioids are the most commonly used treatments for cancer pain management, and, although we might have assumed that there were placebo-controlled trials to support this widespread practice, our findings highlight that the evidence is largely lacking,” wrote lead author Christina Abdel Shaheed, PhD, Senior Academic Fellow at the University of Sydney School of Public Health, Faculty of Medicine and Health.

“There was an absence or paucity of placebo-controlled trials for some of the most commonly used opioid analgesics for cancer pain, including morphine, methadone, buprenorphine, fentanyl, hydromorphone, oxycodone, and tramadol.”

Ironically, Shaheed and her co-authors found that “weaker” opioids such as tapentadol and codeine may work better for cancer pain than the more potent opioids.

They also suggest that NSAIDs and antidepressants are more effective and have fewer side effects for someone with “background” cancer pain who is not nearing the end of life. In effect, they’re saying that opioids are only good if you’re dying.

“In practice, opioids are indispensable for intractable pain and distress at the end of life. What is worth highlighting is that non-opioids, particularly NSAIDs, are surprisingly effective for some cancer pain, and may avoid the problems of dependence and waning opioid analgesia over time,” said co-author Jane Ballantyne, MD, a retired anesthesiologist and professor at the University of Washington.

Ballantyne is Vice President of Clinical Affairs for Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that advised the CDC during the drafting of its controversial 2016 opioid guideline. Like several other PROP members, Ballantyne has worked as a paid expert witness for law firms involved in opioid litigation.

This is not the first time Ballantyne has said that opioids should be used more cautiously when cancer patients are not terminally ill. In 2007, she wrote an op/ed saying that cancer treatment and survival rates had improved so much that opioids should no longer be viewed as the go-to treatment for cancer pain.  

“Cancer was once an explosive, typically terminal disease and became the prototype for end-of-life opioid pain treatment. However, cancer is no longer such an explosive disease, and many cancer sufferers can now expect to have a prolonged, even normal, lifespan. They may need pain treatment, but this treatment should not be modeled on palliative care paradigms,” Ballantyne wrote.

Many cancer patients are already struggling to get pain relief. A recent study found the number of cancer patients seeking treatment for pain in U.S. emergency departments has doubled in recent years. Nearly half of those ER visits were deemed preventable -- meaning they could have been avoided if the patient has received proper pain care earlier.

Other studies have documented how opioid prescriptions and doses have declined significantly for U.S. cancer patients. The Cancer Action Network warned there has been “a significant increase in cancer patients and survivors being unable to access their opioid prescriptions.” 

Are you a pain patient who has trouble getting your opioid prescriptions filled? There’s still time to take PNN’s survey on how opioid shortages are affecting patients at pharmacies. Click here to take the survey, which should only take a few minutes.

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.  

Kolodny Returns as PROP President

By Pat Anson, PNN Editor

After an eight-year hiatus, much of it spent testifying as a paid expert witness in opioid litigation trials, Andrew Kolodny, MD, has been reappointed as president of Physicians for Responsible Opioid Prescribing (PROP), the anti-opioid activist group that he founded. Kolodny succeeds Dr. Jane Ballantyne, who remains with the organization as VP for Clinical Affairs.

“I am delighted to serve in this role again, especially at a time when the need for more cautious opioid prescribing in the United States and abroad is becoming increasingly clear to clinicians, policymakers and the public,” Kolodny said in a press release.

Kolodny served as PROP’s first president from 2010 until 2014, when he was Chief Medical Officer at Phoenix House, a nationwide chain of addiction treatment centers. He is currently the Medical Director of Opioid Policy Research at Brandeis University.

Although Kolodny is a psychiatrist with a background in addiction treatment and lacks expertise in pain management, he has played a prominent role in reducing the use of opioids to treat pain. He lobbied Congress and federal health agencies for years to limit opioid prescribing, and is often quoted making sensational anti-opioid comments in the media, calling them “heroin pills” or saying that over-the counter drugs like ibuprofen “are as effective and in some cases more effective than opioids.”   

He stopped talking to this reporter years ago, saying he doesn’t like my questions and hasn’t had “a good experience” answering them.

Paid Expert Witness

Kolodny’s reinstatement as PROP’s president comes at a time when many opioid litigation cases are wrapping up against drug manufacturers and distributors, resulting in multi-billion dollar settlements with states, cities and counties. The plaintiff law firms who filed and pursued those cases stand to make billions of dollars themselves in contingency fees.

Kolodny was a paid expert witness or consultant for at least four of those law firms (Motley Rice, Nix Patterson, Cohen Milstein and Scott & Scott), making as much as $500,000 when he testified at a rate of $725 an hour in Oklahoma’s lawsuit against Johnson & Johnson.

That case, which resulted in a $425 million verdict against the drug maker, was overturned last year by Oklahoma’s Supreme Court, which ruled that J&J was not the “public nuisance” that Kolodny and the state attorney general portrayed it to be.  

A similar ruling was made by a California judge, who said opioid manufacturers did not use deceptive marketing and were not liable for the state’s opioid crisis. Dr. Anna Lembke, a Stanford psychiatrist and PROP board member, testified as a paid witness for plaintiffs in that case, but Judge Peter Wilson said her testimony about opioid addiction was unreliable.

DR. ANDREW KOLODNY

Court records show that Lembke was paid up to $800 an hour for her testimony in a New York opioid litigation case.

Public records also show that Kolodny was hired as an “expert consultant” by at least one state. In 2020, he signed a contract with the New York State Department of Financial Services to provide “consultation on medical issues and trends regarding the prescription of opioids” at a rate of $600 an hour. In one invoice, Kolodny billed the state $1,500 for making two phone calls. The maximum amount to be paid to Kolodny was later set at $174,999.

In addition to Kolodny and Lembke, at least five other PROP board members have testified as paid expert witnesses or consultants in opioid litigation: Ballantyne, Dr. Danesh Mazloomdoost, Dr. Adriane Fugh-Berman, Dr. Mark Sullivan and Dr. David Juurlink. Mazloomdoost was paid a rate of $850 an hour for his testimony.

PROP members have failed on repeated occasions to disclose these business relationships, but when questions were raised about them, they filed revised conflict of interest statements — without providing details on who they worked for or the amount they were paid.

PROP itself has not been transparent about its finances. PROP is not a public charity and has never filed a tax return. It takes advantage of a loophole in IRS law by having the Steve Rummler Hope Foundation as its “fiscal sponsor,” which allows donors to make tax-deductible donations anonymously.

PROP says it does not accept funding from “pharmaceutical companies and other life sciences corporations.” Kat Marriott, PROP’s Executive Director, did not respond to an email asking if the organization accepted money from law firms, medical device makers, drug testing companies or other industries that have profited from the opioid crisis.  

(Update: This story contains several updates relating to PROP members working as paid expert witnesses and consultants in opioid litigation cases. )

Patient Z and the Criminalization of Pain Care

By Pat Anson, PNN Editor

Dr. Stefan Franzen is not a physician or pain patient, but his new book is likely to open some eyes about the poor quality of pain care in the United States and the consequences of criminalizing opioid medication.

“Patient Z” is Franzen’s pseudonym for a family member who lives with ankylosing spondylitis, a severe form of arthritis, who was cut off from opioids when his longtime doctor came under investigation and was forced to stop prescribing. Patient Z struggled for years to find a new doctor and effective treatment, at times contemplating suicide during bouts of intense pain.  

When Franzen, a chemistry professor at North Carolina State with an extensive background in biomedical research, tried to help by speaking with doctors – he came to the realization that Patient Z and millions of others like him had been stigmatized, terrorized and abandoned in the name of fighting opioid addiction.   

“There are doctors who would like to help patients like Patient Z, but they feel that matters are out of their hands. There is not likely to be major change until the citizens of the United States realize that the denial of pain management care is an attack on patients’ rights and that what happened to Patient Z can happen to anyone,” Franzen writes.

Franzen’s book is comprehensive and well-researched, with several chapters dedicated to debunking some of the myths about opioids, such as addiction and overdoses being inevitable after high doses and long-term use. Those myths have been codified into medical guidelines, laws and regulations to a point where many doctors are now afraid to prescribe opioids or even see pain patients.

“It feels like the tribe is moving on and leaving the patients behind. Our attitude is ‘everybody for themselves’ and the doctors are saying, ‘Hey, I could go to jail.’ And the patients are screwed, which is absurd. The criminalization of medicine is a big part of this problem,” Franzen told PNN.

“My book looks at this from the point of view of the pain patient. What does this look like? And to realize what it’s like when you’re rejected. You’re afraid you’ll be called an addict. You’re afraid someone is going to cut you off at any time.”

Franzen says the war on drugs has been a misguided failure that has only made drug trafficking worse, with pain patients caught in the crossfire. As an example, he points to Florida’s crackdown on pill mills a decade ago.

“When they finally cracked down, there was this massive switch to heroin. It was in 2011 and the heroin numbers shot up. And of course, everyone went to draw the conclusion that the prescription drug crisis caused the heroin crisis. It’s the wrong conclusion,” says Franzen.

“I think the reason the heroin numbers went up is the way they clamped down. They were shutting down methadone clinics. They were making it as hard as possible for anyone with an addiction problem to get help. Here are all these people who got hooked and they’re shutting every single door. What choice do those people have? They can either go cold turkey and go into withdrawal or, suddenly, there’s a lot of heroin available.”

PROP’s ‘Lack of Ethics’

Franzen acknowledges that at one time opioid prescribing was excessive and it was too easy to get opioid medication. But he says the reaction to that by government regulators and law enforcement was “draconian and just absurd.”

Much of the blame for that, according to Franzen, lies with Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that questioned whether opioids were even effective in treating pain. That led to what Franzen calls a “medical coup d’état” in which PROP bypassed the FDA and persuaded the CDC to release its controversial opioid guideline in 2016.

Franzen says if PROP founder Dr. Andrew Kolodny, PROP president Dr. Jane Ballantyne and PROP board member Dr. Anna Lembke were in his chemistry class, he’d give them all F’s.  

“They’d get an F because they misrepresented the facts. And they did things that were intellectually dishonest. I’d actually not give them a grade. I’d kick them out of the class. They cheated,” says Franzen. “Their academic papers are bunk. Part of what I do in this book is debunk them. I do exactly what I would do if I was writing about somebody in chemistry, which is my area of research, who I thought had written something that did not make sense and was not supported by the data.

“They’re ignoring all of these facts or even contradicting themselves. They’re suggesting that a patient has to admit they’re an addict before you can treat them. Huh?”

As PNN has reported, Kolodny and Ballantyne have been well-paid expert witnesses for law firms that stand to make billions of dollars in contingency fees from opioid litigation. But they neglected to mention that conflict-of-interest in several papers and had to make new disclosure statements.

“That too is just stunning to me. The lack of ethics by Kolodny and Ballantyne, specifically, is just jaw dropping,” says Franzen. “I hope they read my book and come after me. I want them to know what I said about them and try to defend themselves, because I don’t think that they can.”   

As for Patient Z, Franzen says he is in palliative care and getting opioids again. He needs to use a walker and wheelchair to get around, but the pain is at least tolerable. Patient Z has also become a fierce advocate for patient rights.      

Do Prescription Opioids Increase Social Pain and Isolation?

By Pat Anson, PNN Editor

Long-term use of opioid medication may increase social isolation, anxiety and depression for chronic pain patients, according to psychiatric and pain management experts at the University of Washington School Medicine.

In an op/ed recently published in Annals of Family Medicine, Drs. Mark Sullivan and Jane Ballantyne say opioid medication numbs the physical and emotional pain of patients, but interferes with the human need for social connections.

“Their social and emotional functioning is messed up under a wet blanket of opioids,” Sullivan said in a UW Medicine press release.

Sullivan and Ballantyne are board members of Physicians for Responsible Opioid Prescribing (PROP), an influential anti-opioid activist group. Ballantyne, who is president of PROP, was a member of the “Core Expert Group” that advised the CDC during the drafting of its controversial 2016 opioid guideline. She has retired as a professor of pain medicine at the university, while Sullivan remains active as a professor of psychiatry.

In their op/ed, Sullivan and Ballantyne say it is wrong to assume that chronic pain arises solely from tissue damage caused by trauma or disease. They cite neuroimaging studies that found emotional and physical pain are processed in the same parts of the human brain.  While prescription opioids may lessen physical pain, they interfere with the production of endorphins – opioid-like hormones that help us feel better emotionally.

“Many of the patients who use opioid medications long term for the treatment of chronic pain have both physical and social pain,” they wrote. “Rather than helping the pain for which the opioid was originally sought, persistent opioid use may be chasing the pain in a circular manner, diminishing natural rewards from normal sources of pleasure, and increasing social isolation.

“To make matters worse, the people who need and want opioids the most, and who choose to use them over the long term, tend to be those with the most complex forms of chronic pain, containing both physical and social elements. We have called this process ‘adverse selection’ because these are also the people who are also at the greatest risk for continuous or escalating opioid use, and the development of complex dependence.”

Sullivan and Ballantyne say doctors need to recognize that when patients have both physical and social pain, long-term opioid therapy is “more likely to harm than help.”

“We believe that short-term opioid therapy, lasting no more than a month or so, will and should remain a common tool in clinical practice. But long-term opioid therapy that lasts months and perhaps years should be a rare occurrence because it does not treat chronic pain well, it impairs human social and emotional function, and can lead to opioid dependence or addiction,” they wrote.

Angry and Depressed Patients

It’s not the first time Sullivan and Ballantyne have weighed in on the moods and temperament of chronic pain patients. In a 2018 interview with Pain Research Forum, for example, Ballantyne said patients often have “psychiatric comorbidities” and become “very angry” at anyone who suggests they shouldn’t be on opioids.

“I’ve never seen an angry patient who is not taking opiates. It’s people on opiates who are angry because they’re frightened, desperate, and need to stay on them. And I don’t blame them because it is very difficult to come off of opiates,” she said.

In a 2017 interview with The Atlantic, Sullivan said depression and anxiety heighten physical pain and fuel the need for opioids. “People have distress — their life is not working, they’re not sleeping, they’re not functioning,” Sullivan said, “and they want something to make all that better.”

JANE BALLANTYNE MARK SULLIVAN

In a controversial 2015 commentary they co-authored in the New England Journal of Medicine, Sullivan and Ballantyne said chronic pain patients should learn to accept pain and get on with their lives, and that relieving pain intensity should not be the primary focus of doctors. The article infuriated both patients and physicians, including dozens who left bitter comments.

“Great job. I will be going into the coffin business thanks to these believers that people should suck it up. How NEJM even recognizes these people as doctors and not quacks is beyond me,” wrote a family practice physician.

“I take just enough narcotic pain meds to cut the edge off of my pain to be coherent enough to love my wife and respond to your constant misinformation,” wrote a patient.

Ballantyne and Sullivan’s op/ed in Annals of Family Medicine has yet to produce a similar response, either pro or con. The article was submitted to the journal over a year ago, but is only being published now.

Ballantyne disclosed in her conflict-of-interest statement that she has been a paid consultant in opioid litigation lawsuits, while Sullivan disclosed that he provided expert testimony for the states of Maryland and Missouri.

Other PROP board members have also found a lucrative sideline testifying in lawsuits. The organization is currently conducting a fundraiser to hire a new Executive Director to “take PROP's work to the next level.”

PROP President Discloses Conflicts of Interest

By Pat Anson, PNN Editor

The president of Physicians for Responsible Opioid Prescribing (PROP) – an influential anti-opioid activist group – has worked as a paid consultant for the national law firm of Motley Rice, which stands to make billions of dollars in contingency fees from opioid litigation.

Dr. Jane Ballantyne disclosed her work with Motley Rice in a revised disclosure statement recently made public by the Annals of Internal Medicine, a prominent medical journal. Ballantyne co-authored an op/ed in the journal in September that called for “every patient receiving long-term opioid therapy” to be assessed by doctors for tapering off the drugs.

In her original conflicts of interest statement, Ballantyne did not disclose her work for Motley Rice, her affiliation with PROP or any other conflicts. 

“In a recent Ideas and Opinions commentary, Dr. Ballantyne did not disclose that she has received personal fees for the multidistrict opioid litigation because her consultancy in the litigation was under a confidentiality agreement. Dr. Ballantyne has now updated her disclosure because her role in the multidistrict litigation has since become public knowledge,” the medical journal said in a statement.

Ballantyne did not disclose the amount of compensation she received from Motley Rice.

Dr. Anna Lembke, a Stanford psychiatrist who co-authored the Annals article, said in her initial disclosure statement that she was also a paid expert witness in opioid litigation, but did not reveal what law firm she works for. In a new statement, Lembke discloses that she is a PROP board member.

“In the spirit of full transparency, Drs. Ballantyne and Lembke have decided to disclose their involvement in Physicians for Responsible Opioid Prescribing (PROP) as well. PROP is a 501c3 charitable organization. Their roles are volunteer positions without financial remuneration,” the journal said.

The claim that PROP is a 501c3 non-profit organization is puzzling because PROP is not a registered charity with the Internal Revenue Service. Instead it uses the Steve Rummler Hope Network as its "fiscal sponsor" -- an IRS designation that allows PROP to piggyback onto another organization’s 501c3 status. Because it is not a charity, PROP has never filed a federal or state tax return and is not required to disclose anything about its revenue, donations or spending.

Ballantyne and Lembke are not the first PROP members to revise their financial disclosure statements or to work as paid consultants in opioid litigation. PROP founder and Executive Director Dr. Andrew Kolodny recently revised his conflict of interest statements for the Journal of the American Medical Association (JAMA) to include his work in opioid malpractice lawsuits.  

DR. JANE BALLANTYNE

Ballantyne, a retired anesthesiologist and professor at the University of Washington School of Medicine, is a controversial figure in the pain community because of her role in drafting the CDC’s controversial 2016 opioid prescribing guideline. Many blame the guideline for a surge in suicides by patients who were abandoned by their doctors or forcibly taken off opioids.

Although Ballantyne was known to have strong negative opinions about prescription opioids and worked in the past as a paid consultant for Cohen Milstein Sellers & Toll  -- another law firm involved in opioid litigation – she was still allowed to serve on the “Core Expert Group” that advised the CDC when it drafted the guideline. Several other PROP members also served as advisors to the CDC, which the agency did not disclose until it was threatened with a lawsuit.

Lucrative Sideline

As PNN has reported, working as a paid consultant or expert witness has become a lucrative sideline for Kolodny and other anti-opioid activists. The lawyers that hire them are eager to have them testify in opioid litigation cases that will likely reward their law firms with billions of dollars in contingency fees.  

Kolodny recently testified as the “star witness” for Oklahoma in its opioid negligence lawsuit against Johnson & Johnson. For that, he was paid $725 an hour by Nix Patterson & Roach, one of three law firms hired by Oklahoma to handle the case against J&J. Kolodny, who stands to make up to $500,000 for his testimony in the Oklahoma case, also acknowledged working as a consultant for Cohen Milstein at a rate of $725 an hour.

Cohen Milstein and Motley Rice are lead counsels in a national opioid litigation case in Cleveland that has consolidated about 2,600 lawsuits filed by states, cities and counties against opioid manufacturers and distributors. According to Legal NewsLine, the law firms could take home 40% of any settlements, which are projected to reach about $50 billion.

“The firm that stands to win the most will likely be Motley Rice, which pioneered the strategy of joining forces with government attorneys to sue the tobacco industry in the 1990s. Motley Rice name partner Joe Rice has never revealed his personal take from the $260 billion tobacco deal but private lawyers in total will receive $14 billion from the multi-year agreement,” Legal Newsline reported.   

Ohio Attorney General Dave Yost has complained that legal fees in the opioid litigation case are too high. The judge has also warned attorneys to fly coach and limit their hotel rooms to $450 a night.

Many of the lawyers involved in the case are major political donors. Motley Rice attorneys gave over $700,000 to political candidates in 2018, while the law firm of Simmons Hanly Conroy donated over $1 million, much of it going to Missouri Sen. Claire McCaskill (D) in her failed bid for reelection.

Coincidentally, McCaskill released a report last year that was sharply critical of physician and patient advocacy groups for accepting money from opioid manufacturers. Three organizations cited in the McCaskill report — the American Academy of Pain Medicine, American Geriatric Society, and the American Pain Society — were named as defendants in opioid lawsuits filed by Simmons Hanly.  

Lessons from 'American Overdose' on the Opioid Crisis

By Roger Chriss, PNN Columnist

The book “American Overdose: The Opioid Tragedy in Three Acts” by Chris McGreal takes a hard look at the opioid crisis. The book focuses on the legal and political side of the crisis, along with a history of Purdue Pharma and OxyContin, and a detailed description of pill mills and rogue pharmacies in Appalachia.

“It is a tragedy forged by the capture of medical policy by corporations and the failure of institutions in their duty to protect Americans,” is how McGreal describes the genesis and evolution of the crisis.

The book highlights the massive collusion and corruption in communities in West Virginia and Kentucky, leading to the Williamson Wellness Center and other pill mills that were protected by law enforcement, ignored by state and federal regulators, and encouraged or exploited by drug manufacturers and distributors.

McGreal also traces the history of Purdue and the Sackler family, and how their efforts to improve pain management led to the creation of the blockbuster drug OxyContin. He explains how Purdue’s marketing claims “proved to be demonstrably false, including an assertion that addiction is rare when opioids are taken under a doctor’s care.”

However, McGreal does not depict Purdue as a lone bad actor. Instead, federal and state dysfunction and disinterest contributed to the crisis. “The FDA wasn’t the only one to drop the ball. A clutch of federal agencies with long names have responsibility for combating drug addiction and overdose,” he wrote. And they all failed.

The failure was both systemic and systematic. As the crisis unfolded, local law enforcement had to contend with “indifference and what they regarded as the political cowardice of the system.” Perhaps more important than the cowardice and corruption was greed, not just corporate greed but also local greed for the money brought in by pill mills: “The businesses did good. You had pharmacies that were doing really good.”

The problem soon extended far beyond Appalachia. Among the earliest and biggest pill mills was American Pain, set up in 2007 near Fort Lauderdale, Florida by twin brothers Chris and Jeff George – neither of whom had medical training.

Opioid addiction also rose across the nation because of cultural factors, writes McGreal. In Utah, “the dominance of the conservative Church of Latter-day Saints appeared to be a cause of addiction, not a deterrent” because of the church’s “toxic perfectionism.”

Government agencies and officials were encouraged to ignore it all. Florida Sen. Marco Rubio’s office wasn’t interested in pursuing pill mills and the “political leadership within Florida wasn’t much better.”

Rudy Giuliani, Eric Holder, and James Comey all helped Purdue, according to McGreal, by delaying investigations of the company as addiction and overdose rates rose rapidly in the 2000’s.

The CDC’s involvement is described as delayed and dysfunctional. "Until 1998 the United States used a classification system lumping heroin, morphine, and prescription opiate deaths together," McGreal points out. Even when CDC researcher Len Paulozzi documented rising trends in overdose deaths, no one paid serious attention until Thomas Frieden, MD, became director. Even then, serious flaws remain in how the CDC reports on overdose deaths.  

Anti-opioid activists Andrew Kolodny, MD, founder of Physicians for Responsible Opioid Prescribing (PROP), and PROP President Jane Ballantyne, MD, sounded warnings about opioids, but offered little in the way of solutions outside of cutting off prescriptions. Many of their warnings proved to be unfounded, in particular with the opioid analgesic Zohydro. The drug was approved by the FDA amid dire warnings of a major spike in addiction and overdoses, but “there was no great surge of overdoses because of Zohydro.”

“FDA officials don’t like Kolodny. They characterize him as unreasonable and difficult. One described him as a ‘complex character’,” McGreal writes.

Similarly, the 2016 CDC opioid prescribing guideline is described as too late to be useful. McGreal looks closely at the debate about the CDC guideline and recommendations from the 2017 opioid commission set up by President Trump. But despite these much-touted steps, “little changed on the ground for states desperate for treatment facilities and help with the social costs of the tragedy.”

The book concludes on a pessimistic note, captured in a comment from Nathaniel Katz, MD, about opioid addiction and overdose: "I don’t really see any prospect for intelligent policy in this area in the United States.”

McGreal summarizes his ideas with an indictment of American culture.

"In large parts of the United States, opioids were popular because they were a fix. A fix for emotional pain. A fix for failing bodies. A fix for struggling to make it in a society that promises so much, and judges by what is achieved, but turns it back on so many of those who fail to live up to that promise," he writes.

If “American Overdose” offers lessons, it is that the opioid crisis is a result not only corporate greed but also American culture; in particular politicians, regulators and a broader medical industry with agendas contrary to the public good. The book is an origin tale of the opioid crisis that offers little hope for the future.

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

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

Better Analysis Needed on Non-Medical Use of Opioids

By Willem Scholten, PharmD MPA, Guest Columnist

A few months ago, the medical journal World Psychiatry published an article that focused on the global non-medical use of prescription drugs, particularly psychoactive substances such as opioids.

Unfortunately, the two authors -- Dr. Silvia Martins and Dr. Lilian Ghandour -- ignored the distinction between prescription and prescribed opioids, adding unnecessary confusion to the already complex debate about access to pain treatment. Further, Dr. Martins said in the Washington Post that the non-medical use of psychoactive substances could turn into a pandemic if we are not careful.

Both authors are affiliated with Columbia University’s Mailman Institute of Public Health, which claims to work in the interest of underserved people in developing countries. Access to effective pain treatment in developing countries is already now more difficult than in the U.S.

Elsewhere, I have demonstrated that access to prescribed opioids for adequate pain treatment is a problem for 5.5 billion people living in countries where opioid analgesics are not available or inaccessible for patients in need.

In most countries, the per capita consumption of legitimately prescribed opioid analgesics (as officially reported to the International Narcotics Control Board) remains much lower than in the U.S. and Canada, in extreme cases even up to 50,000 times lower.

Distinction Between “Prescribed” and “Prescription” is Key

There is a vast difference between prescription and prescribed opioids. Prescription opioids are intended to be prescribed as medicines. Prescribed medicines are actually prescribed by a physician and dispensed by a pharmacy.

About 75% of fatal overdoses from prescription opioids in the U.S. occur in people who have not been prescribed opioids during the three months preceding their deaths. Thus, the majority must have obtained these prescription opioids on the black or gray market.

Without referencing the data, Drs. Martins and Ghandour claim that prescription opioids are causing serious problems in other parts of the world. However, data from the European Monitoring Centre for Drug and Drug Addiction and the European Drug Report indicate that diversion of prescription opioids is not a serious problem in Europe. In other regions of the world, per capita prescription of opioids is very low.

Drs. Martins and Ghandour claim a high prevalence of non-medical use of prescription opioids in Saudi Arabia. However, those medicines are hardly ever prescribed in that country and medical consumption rates are only about 2.5 % of the U.S. volume. Therefore, Saudi Arabia’s non-medical use of prescription opioids can hardly originate from prescribed opioids.

Unfortunately, World Psychiatry refused to publish a letter I wrote with other experts which addressed the misunderstandings stemming from Drs. Martins and Ghandour’s article.

PROP and the Anti-Opioid Lobby

The anti-opioid lobby in the U.S. does not shy away from using arguments not based on facts, just like Drs. Martins and Ghandour in their article. For example, Physicians for Responsible Opioid Prescribing (PROP) perpetuates the mistaken conflation of prescription and prescribed opioids, advocating in the U.S. against the legitimate medical prescribing of opioid analgesics. PROP tries to justify its position using false statistics, as I demonstrated in a recent publication.

Moreover, PROP leadership participated in drafting the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain. PROP Executive Director Dr. Andrew Kolodny disclosed his involvement, but PROP President Dr. Jane Ballantyne and PROP Vice President Dr. Gary Franklin did not list the group as a relevant conflict of interest on their disclosure forms.

The Steve Rummler Hope Foundation is the “fiscal sponsor” of PROP. Its vision is “a world where individuals with chronic pain receive integrated care focused on wellness rather than drugs.” For patients with moderate or severe pain, this can hardly be an effective and humane treatment. PROP’s close ties with the Steve Rummler Foundation are revealed by Dr. Kolodny’s and Dr. Ballantyne’s membership on its medical advisory committee.

Policies Should Balance All Public Health Interests

Indeed, it is correct to attend to the non-medical use of psychoactive substances. However, the situation outside the U.S. is really different. In many countries, patients have no access to adequate pain management. Measures to address non-medical use of opioids should not hamper access to effective pain management.

Policymakers in countries with a low per capita medical opioid consumption and low prescription rates should first analyse how prescription opioids that have not been prescribed enter circulation. The relationship between the non-medical use of prescription opioids and illicitly produced substances such as heroin should also be taken into consideration. Then, appropriate interventions to halt the diversion should be developed.

In parallel, policymakers should develop policies aimed at ensuring adequate provision of pain treatment as recommended by the World Health Organization. Optimal public health outcomes can only be attained when policies to minimize non-medical use are balanced with policies to maximize access to adequate pain management. Crafting such policies entails correctly distinguishing between prescribed and prescription opioids.

Willem Scholten, PharmD MPA, is an independent consultant for medicines and controlled substances at Willem Scholten Consultancy in the Netherlands. This has included work for DrugScience, Grünenthal, Jazz Pharmaceuticals, Mundipharma, Pinney Associates and the World Health Organization. Dr. Scholten is also a board member of International Doctors for Healthier Drug Policies.

He wishes to acknowledge Dr. Katherine Pettus for her contribution to this article.

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

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

From Bad to Worse for Pain Patients?

By Pat Anson, Editor

Has the pendulum swung too far against pain patients?

The answer is "Yes" according to some leading pain management experts at the annual meeting of the American Academy of Pain Medicine (AAPM) in Palm Springs.  The AAPM represents 2,400 physicians and health care providers, including some who have stopped prescribing opioid pain medication because they fear prosecution or sanctions if they prescribe to patients who might abuse the drugs.

"There are a variety of primary care doctors that are dropping out altogether (from prescribing opioids). They will not allow it. They're saying everybody has to go to a pain management expert or you don't get anything. And its abrupt," said Bill McCarberg, MD, President of the AAPM. "For that group of patients, you're cutting everybody off inappropriately. There are some of those patients who probably need those medications, who do better with medications."

McCarberg, who volunteers at a health clinic in San Diego, says even opioids with abuse deterrent properties are difficult to prescribe because they are expensive and usually not covered by insurance. He is not optimistic about the continued use of opioids in pain management.

"In my experience over the last year its gotten worse and I think a year from now it will be even worse," McCarberg said. "When you come back here in five years, in ten years, we'll be having the discussion about the pendulum being over here, patients suffering.  About you getting shoulder surgery and getting nothing but acetaminophen to treat your shoulder because nobody is willing to give you more (opioids). That's what I worry about."

"I think that's right. I think the pendulum has swung in the direction of things being worse for patients very rapidly and very dramatically. And I don't think its finished swinging yet," says Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

"I think its the general atmosphere, the whole focus on opioid overdoses and all of that stuff.  That's what is driving the CDC's actions and every bit of the press that's out there is about that problem. And until we get the other side of the story out there and point out that not treating pain has negative consequences too, including people dying, until we can get that story out there and get some traction with it, patients are in a bad place."

PROP President Speaks to AAPM

Although the AAPM has "very significant concerns" about the quality of evidence and "negative bias" in some of the CDC's proposed opioid prescribing guidelines, it invited a controversial figure who helped draft them to its annual meeting. Jane Ballantyne, MD, who is president of Physicians for Responsible Opioid Prescribing (PROP), served on a CDC advisory panel known the "Core Expert Group." The CDC guidelines discourage primary care physicians from prescribing opioids for chronic pain.

Ballantyne, who gave a talk at the AAPM meeting on "Pain Curriculum Development for Primary Care Practitioners," recently come under fire for co-authoring an article in the New England Journal of Medicine that said reducing pain intensity should not be the primary goal of doctors that treat chronic pain. 

Several patient advocates asked AAPM to remove Ballantyne from the program.

"How, in good conscience, can you include someone with her views about pain teach other physicians, or influence future curriculum for physicians, on how to effectively treat pain? It is clear from her writings that she doesn’t understand pain, or painful disease processes. Should someone with views like this be influencing our present and future doctors?" wrote Ingrid Hollis of Families for Intractable Pain Relief in a letter to the AAPM.

"While I appreciate your concerns about including Dr. Ballantyne as a member of the faculty, the Academy will not comply with your request that it remove her from the program," responded Phil Saigh, Jr., Executive Director of AAPM. "The Academy is committed to the free exchange of information and perspectives among pain physicians and other clinicians.  It is this commitment that ensures that diverse perspectives are examined rather than creating a one-size-fits-all approach to education. To remove Dr. Ballantyne from the program would not be true to that commitment."

Ballantyne's presentation was low key and did not focus on opioid use. She spoke about improving pain curriculum in medical schools, an area where there is broad agreement that change is needed. 

"Pain education has been really, really bad. And a large part of the problem, in terms of primary care, is actually managing those with chronic pain and not having received any education on how to do that," said Ballantyne, who explained that her own education and training in the 1970's focused on pain medication and injections, and did not include other disciplines such as psychology.

"The evidence suggests strongly that entry level pain management training is widely inadequate across all disciplines in the United States. Only a few medical schools in Canada and the U.S. offer courses on pain," she said. "The young primary care physicians that I work with are suddenly faced with this extremely complex disease, chronic pain, and they have only been taught to see it in a unitary way. That's what leads to a very simple treatment goal, which is simply to reduce pain intensity.

JANE BALLANTYNE, MD

"When we treat chronic pain we do an awful lot more or want to achieve an awful lot more than simply reducing pain intensity. We want to improve people's lives. We want to help them function better. We want to improve their state of mind and their mood, and have to pay attention to all the other factors that contribute to the disease. Chronic pain is a complex disease that is not simply a focus on pain intensity. And that's one thing we can really help in our teaching."  

All Things Considered: Except Patients

By Pat Anson, Editor

National Public Radio’s All Things Considered is one of the most respected radio programs in the country, reaching nearly 12 million listeners each week.

So when All Things Considered aired a two-part series this week on the opioid prescribing guidelines being developed by the Centers for Disease Control and Prevention (CDC), many expected an in-depth and balanced report on America’s love-hate relationship with opioids – how a medicine that gives pain relief to millions is also responsible for the deaths of thousands who abuse it.

Host Robert Siegel said the nation was at a “turning point” in its complicated relationship with opioids. The broadcast interviewed pain specialists, a family physician, and various experts who said the CDC guidelines either go too far or are long overdue.

“We have a moral responsibility to address pain and suffering. And we do have a responsibility not to do harm, but you can do harm in either direction,” said Richard Payne, MD, of Duke University.

“The number of deaths is only the tip of the iceberg, that's just indicating the pyramid of problems that lies beneath,” said Jane Ballantyne, MD, President of Physicians for Responsible Opioid Prescribing (PROP).

Completely missing from the report was the voice of pain patients. Many noticed the omission and left comments on NPR’s website.   

“Please consider interviewing real chronic pain patients. Everyone seems to be making decisions about our treatment but no one asks us how these medications work for us,” wrote one pain sufferer.

“Sorry but NPR screwed up majorly on this piece – they had no panel of patients to give their thoughts – considering how terrible pain patients are treated, that would have been a good angle,” wrote Cary Brief.

“The recent public discussion on opiates, which paints all opiate users as addicts or drug-seeking, is not only unhelpful, it is exceedingly harmful to patients like myself who take their medications as prescribed,” said a woman who suffers from chronic back pain.

“I am amazed at my beloved NPR not doing their homework on this,” wrote Kristine Anderson. “You have just labeled yourself another media outlet getting your information from only the CDC (other than Dr. Payne perhaps) and creating feed off of their press releases, timely sent just as the guidelines comments were reopened and soon to close.”

Anderson also wrote she was disappointed that the broadcast included a lengthy interview with Ballantyne, a retired pain specialist who has recently emerged as a controversial figure in the debate over opioids. As Pain News Network has reported, Ballantyne is one of five PROP board members who are advising the CDC and her inclusion in a secret panel of experts is one of the reasons the agency delayed implementing the guidelines and reopened a public comment period.

Critics have said Ballantyne is biased, has a financial conflict of interest, and should be fired from her academic position at the University of Washington School of Medicine for advocating that pain intensity not be treated.

None of that was reported by All Things Considered, which gave Ballantyne a prominent role in the broadcast. Ballantyne told the program that during her lengthy career in pain management she and other doctors were sometimes abused and insulted by “awful” pain patients when they tried to wean them off opiates.

“If you give people opiates, they think you're the best thing since sliced bread. They love you. They just worship the ground you walk on. The moment you suggest that you want to try and get them down on their dose or, worse still, say you can't carry on prescribing - not that I do that myself; I never cut people off; I don't think people should be cut off, but I do try and persuade them to come down on their dose - they are so awful,” Ballantyne said.

“And you can see why people who are not seeped in this stuff - the young primary care physicians just don't know what to make of it. They don't want to be abused. They want to be loved like everybody else does. We go into medicine to try and help people. And when you get abused and, you know, insulted, you can see why it perpetuates itself.”

Ballantyne said patients on high doses of opiates “were absolutely miserable, were not doing well, were medically ill and always had severe pain." It was then that she and her colleagues began to think "the opiate wasn't helping, and maybe it was harming.”

You can listen to Ballantyne in the first part of NPR’s story, by clicking here.

The second part -- an interview with Dr. Wanda Filer, president of the American Academy of Family Physicians -- can be heard by clicking here.

Controversy Grows over Journal Article on Pain Treatment

By Pat Anson, Editor

It’s not uncommon for colleagues in the medical profession to disagree. Egos and different medical backgrounds can sometimes lead to heated discussions about the best way to treat patients. But those arguments are usually kept private. 

That is why it is so unusual for a prominent pain physician to publicly call for another doctor to resign or be fired from her faculty position at a prestigious medical school.

“I believe she should resign her academic post,” says Forest Tennant, MD, referring to Jane Ballantyne, MD, a professor at the University of Washington School of Medicine, who recently co-authored a controversial article in the New England Journal of Medicine (NEJM) that said reducing pain intensity should not be the goal of doctors who treat chronic pain. The article also suggests that patients should learn to accept their pain and move on with their lives.

“For somebody in her position as a professor at a university to call for physicians to quit treating pain – or pain intensity – whether acute, chronic, whether rich, poor, disabled or what have you, is totally inappropriate. And it’s an insult to the physicians of the world and an insult to patients. And frankly, she should not be a professor.” Tennant told Pain News Network.

“To suggest that physicians should no longer treat pain intensity and let patients suffer goes beyond any sort of decency or concern for humanity.”

Tennant is a pain management specialist who has treated patients for over 40 years at his pain clinic in West Covina, California. He’s authored over 300 scientific articles and books, is editor emeritus of Practical Pain Management, and is highly regarded  in the pain community for accepting difficult, hard-to-treat patients that other doctors have given up on.

dr. forest tennant

Tennant was surprised the influential, peer-reviewed New England Journal of Medicine, which reaches over 600,000 people each week, even published the article.

“I know that they’re biased and they’ve got all their medical device people there and all their academia and all that, but I think they have a responsibility also. They are supposedly representing medicine,” says Tennant. “Why do I have a medical degree if I’m not supposed to treat pain intensity? Give me an answer to that. She didn’t have an alternative did she?”

dr. jane ballantyne

Exactly what Ballantyne and co-author Mark Sullivan, MD, meant to say is open to interpretation. Pain News Network has been unable to get comment from either about the controversy.

They began their article by saying “pain that can be relieved should be relieved,” but then veer off in another direction, stating that chronic pain should not be treated with opioid pain medication.

“Is a reduction in pain intensity the right goal for the treatment of chronic pain? We have watched as opioids have been used with increasing frequency and in escalating doses in an attempt to drive down pain scores — all the while increasing rates of toxic drug effects, exposing vulnerable populations to risk, and failing to relieve the burden of chronic pain,” they wrote, dismissing the pain intensity scales that are widely used by physicians to measure pain levels.

“We propose that pain intensity is not the best measure of the success of chronic-pain treatment. When pain is chronic, its intensity isn't a simple measure of something that can be easily fixed.”

Ballantyne and Sullivan offered no alternative “fixes” for pain treatment, other than patients learning to live with pain and sitting down for a chat with their doctors.

“Nothing is more revealing or therapeutic than a conversation between a patient and a clinician, which allows the patient to be heard and the clinician to appreciate the patient's experiences and offer empathy, encouragement, mentorship, and hope,” they wrote.

Angry Comments from Readers

The article infuriated both patients and physicians, including dozens who left angry comments on the NEJM website.

“Great job. I will be going into the coffin business thanks to these believers that people should suck it up. How NEJM even recognizes these people as doctors and not quacks is beyond me,” wrote Michael Shabi, who identified himself as a family practice physician.

“I take just enough narcotic pain meds to cut the edge off of my pain to be coherent enough to love my wife and respond to your constant misinformation. I have had 21 neurological surgeries and procedures and live in constant pain. So why in the heck do you people have such a problem in hearing us?” asked pain patient Kerry Smith.

“Only an idiot might conclude that one can dismiss the effects of living with a healthcare problem that reminds you of its presence with every move you make,” wrote Terri Lewis, PhD, a specialist in rehabilitation.

Both Ballantyne and Sullivan have lengthy careers in medicine and have been active in organizations that discourage the use of opioids. 

According to the University of Washington website, Ballantyne received her medical degree from the Royal Free Hospital School of Medicine in London and trained in anesthesiology at John Radcliffe Hospital in Oxford. She moved to Massachusetts General Hospital in Boston in 1990 and then to the University of Washington in 2011, as a Professor of Education and Research and as Director of the UW Pain Fellowship. 

Last year Ballantyne was named president of Physicians for Responsible Opioid Prescribing (PROP), an advocacy group funded by Phoenix House, which operates a chain of addiction treatment centers. She also serves as an expert adviser to the Centers for Disease Control and Prevention (CDC) as it develops controversial new guidelines that discourage primary care physicians from prescribing opioids. Ballantyne is one of five PROP board members who are advising the CDC on the guidelines.

Sullivan is a Professor of Psychiatry and Behavioral Sciences -- also at the University of Washington School of Medicine -- and is executive director of Collaborative Opioid Prescribing Education (COPE), a program that educates healthcare providers about safe opioid prescribing practices. He is also a PROP board member.

Sullivan has authored several research articles on opioids, including a recent one warning about the co-prescribing of sedatives and opioids.

“He’s not as well known,” says Tennant. “He doesn’t carry the public influence that she does. She’s sitting on federal committees, advising CDC that pain patients should not be treated and the intensity scale should not be used. I cannot imagine anyone making that statement. I can’t imagine the New England Journal of Medicine publishing it. The atrocity here is just awful.

dr. mark sullivan

“Any semblance of decency left among physicians in PROP, if that’s what they believe, then I think the whole organization ought to close its doors. I didn’t know they were going to say we didn’t want pain treated at all. They said they wanted to use opioids responsibly. Well, that’s fair. But that’s not what she said.”

Tennant is urging the pain community to contact Paul Ramsey, the CEO of UW Medicine and Dean of the School of Medicine to ask that Ballantyne be fired. He’s gotten a few takers, including Becky Roberts, who suffers from arachnoiditis.

“I do not feel she should be teaching new medical students. Professor influence is big when you are a student. I am sure if any one of them read her article, most were probably shocked,” Roberts said in an email to Pain News Network.

“They did not get into medicine because they are uncaring. Compassion for other human beings is why they went to medical school. To help heal human beings is their goal. I really do think she needs to be removed from that position. How long has she been teaching this kind of logic?”

The UW School of Medicine has about 4,500 students enrolled in undergraduate, professional, and post-graduate programs.