Sens. Manchin and Markey Want Opioid Research Stopped

By Pat Anson, PNN Editor

Seven years ago, Sens. Ed Markey (D-MA) and Joe Manchin (D-WV) wrote a letter to the acting administrator of the Drug Enforcement Administration, asking for stricter limits on the production of opioid pain medication. They joined with over a dozen of their colleagues with another letter in 2017, asking for the same thing.

The letters said too many Americans were becoming addicted to opioids and that there was “insufficient research body about the effectiveness of opioids when used long term.”

The letters and a personal meeting with the DEA administrator had an impact. The agency embarked on a years-long campaign to slash production quotas for opioid manufacturers, which now stand at their lowest levels in two decades. Since their peak, DEA production quotas have fallen by 65% for oxycodone and 73% for hydrocodone. And the U.S. now has chronic shortages of opioid medication.    

Flash forward to 2023, and Sens. Markey and Manchin are at it again, but in a different way.  

In a new letter --- this time to the Food and Drug Administration – the senators called on the agency to scrap plans for a new clinical trial that could help prove whether opioids are effective long term – the very thing the senators said there was “insufficient research” on just a few years ago.

“Other studies have already evaluated prolonged opioid use,” Markey and Manchin wrote in their letter, which was first reported by STAT.

SENS. JOE MANCHIN AND ED MARKEY

At issue is an FDA plan to use a research design known as enriched enrollment randomized withdrawal (EERW) to study the use of opioids by patients with chronic pain – persistent pain that lasts for over three months.  Such a study would require patients on extended-release morphine to either continue taking the medication or be unwittingly switched to a placebo – which would essentially amount to a rapid taper with no pain relief.  

Markey and Manchin say such a study is biased in favor of opioids and would “needlessly expose” patients on morphine to the risk of addiction. They also make the dubious claim that long-term clinical studies of opioids are no longer needed, citing a controversial Australian study – known as the OPAL study -- that found low dose opioids gave little relief to patients with back and neck pain.

“A recent randomized placebo-controlled study found that prolonged opioid use was ineffective for acute back and neck pain. The study found that after six weeks, there was no significant difference in pain scores for the patients taking opioids compared to those who took a placebo,” the senators wrote.

Critics were quick to note the OPAL study has a number of flaws, the most obvious one being that the treatment period only lasted six weeks. OPAL was a short-term study of opioids for acute pain – not “prolonged opioid use” as Manchin and Markey claimed.   

“The letter by Markey and Manchin is a phenomenon of misinformation and lack of understanding of the opioid crises,” said Stephen Nadeau, MD, a Professor of Neurology at the University of Florida College of Medicine.

“The OPAL study indisputably examined only ACUTE neck and back pain; it is completely inappropriate to apply its results to chronic pain,” said Chad Kollas, MD, a palliative care physician and pain policy expert.

Kollas posted a long thread on Twitter (now known as X) debunking other aspects of the OPAL study, saying its findings were “overstated & oversimplified to support the policy agenda of opioid reductionists.”

“I believe Manchin and Markey are being influenced to shut down any public funding of research that would demonstrate positive benefits for the long-term use of opioids -- of which, enriched enrollment trials are a prime example. By whom, I do not know,” says patient advocate Richard “Red” Lawhern.   

The “whom” in this case appears to be Dr. Andrew Kolodny, the president and founder of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that is funded by dark money. Several PROP members, including Kolodny, have repeatedly failed to disclose their conflicts of interest and enriched themselves by testifying as paid expert witnesses in opioid litigation cases.  

Kolodny has worked previously with Manchin on anti-opioid legislation and is apparently doing so again. Manchin is co-sponsoring a bill that would require the FDA to review the use of EERW studies on opioids. Kolodny is quoted in a recent Manchin press release promoting the senator’s bill. 

“The FDA has been putting new painkillers on the market based on improper studies that skew results in favor of approval. The methodology they're using was cooked up in private meetings with drug makers. The time for outside experts to examine the use of enriched enrollment randomized withdrawal is long overdue,” said Kolodny, who is Medical Director of Opioid Policy Research at Brandeis University.  

Coincidentally, when the OPAL study was published in The Lancet medical journal, it was accompanied by an invited commentary from two other PROP members, Drs. Jane Ballantyne and Mark Sullivan, who said the study “raises serious questions about the use of opioid therapy for acute low back and neck pain.”

More Opioid Studies Needed

Although opioids have been used for thousands of years for pain relief, there are surprisingly few placebo-controlled clinical studies of their long-term effectiveness. That is mainly due to the ethical issues involved in giving a placebo to someone in pain. Few pain patients would want to participate in a long-term study in which there’s a good chance they don’t get any pain relief. And few studies duplicate the real world experiences of pain sufferers.

“Depriving patients of benefits they might gain from receiving LTOT (long term opioid therapy) ethically precludes using randomized controlled studies (RCTs) as a research method in studying LTOT. This necessitates using other types of research, including the type of research that the senators seek to eliminate,” Kollas told PNN.

“The reason that RCTs of opioids for chronic pain have failed is very simple:  the trial design is fundamentally flawed. It is simply not adequate to address the scientific question at hand,” says Nadeau. “EERW trials have shown promise, and certainly more evidence of efficacy then the conventionally designed trials, but they have their problems.” 

Nadeau and other have proposed that EERW studies be modified so that patients on opioids are gradually tapered, not just suddenly switched to a placebo. 

“What is glaringly evident is that the gold standard of randomized double-blind trials cannot be applied with opioids because of very high failure rates in the placebo arm, due to breakthrough pain,” said Lawhern. “Moreover, even short-term trials are invalidated by protocols that do not remotely resemble actual clinical use of these medications.”  

As flawed as they might be, EERW studies may be a way to fill in some of the missing gaps in opioid research. Do opioids work long-term? Do they inevitably lead to addiction?  Are chronic pain patients helped or harmed by using opioids? Those are simple questions we still don’t have definitive answers to – and may never know if politicians dictate health policy and try to block much needed pain research. 

“We ask the FDA not to permit the use of EERW to determine the long-term efficacy and tolerability of opioids in chronic pain patients. We also urge you to reject EERW study designs for any future new drug applications for opioids and reconsider past opioid approval decisions using EERW,” Manchin and Markey wrote.

The Real Hoax About Prescription Opioids

By Barby Ingle, PNN Columnist

How many have to die? How many have to be denied? How many have to suffer unnecessarily?

Those are some of the questions I’m asking after reading a recent article in The Guardian about the CDC’s revised opioid guideline. The article has a few misstatements about prescription opioids that I have issues with. 

Before I share my take, I want readers to know that I do not take opioid medications myself. I have taken them in the past, but found other treatments that were more effective, so I stopped taking opioids in 2009. I also have an allergy to OxyContin, which I discovered after a knee surgery.

In 2018, I underwent pharmacogenomic testing, which I highly recommend for anyone who has chronic physical conditions. It has given me the best precision care available. I still live with multiple chronic pain and rare diseases, and will need treatment for the rest of my life.

You may be aware that I recently stepped down as president and a board member of the International Pain Foundation (iPain). It was a completely volunteer position. I have been advocating through many nonprofits since 2006 and have always been transparent about any funding that the charity or I received. I also have a degree from George Mason University in Psychology.

Which brings me back to the claims about addiction, opioids and patient advocacy that Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing (PROP), made in The Guardian article. This quote is from Kolodny about patient suicides:

“This is a really serious issue. But what the opioid advocates, many with industry ties, disclosed or undisclosed, pushed was this false narrative about an epidemic of suicide and so there was a manufactured backlash against the CDC guidelines.

“The notion that there are patients losing access to an effective treatment, and therefore they have no choice but to kill themselves because they’re in so much pain now, that’s a hoax. But the idea that someone in the context of acute withdrawal would kill themselves, that certainly could be real because it’s so excruciating.”

From the perspective of a pain patient and a former nonprofit board member, I want to set the record straight about Kolodny’s alleged “hoax.” Yes, addiction is a serious issue. Under-treatment of chronic pain is also a serious issue. Any mistreatment of people with chronic care challenges is an issue.

The healthcare system in the U.S. is working as it was designed and needs to be thrown out. We are all individuals and should be treated by the providers of our choosing to get the care that we need — not as the healthcare system dictates. Not every provider is great, not every patient is great, and no treatment works for everyone. 

In America, we live in a “free” society. I believe we should be able to choose our own care and moral stance. But I wonder why Kolodny believes his moral stance should supersede what a provider and patient feel is best, whether it’s addiction treatment, pain management or any particular choice of care.

We should have full access to whatever we are willing to do to our own bodies. I have said many times over the years that I do not want to be a guinea pig anymore. I work hard to manage my pain levels, my surroundings, my energy pennies, and the people around me.

‘Advocates With Industry Ties’

Kolodny claims that many “opioid advocates” have industry ties and manufactured a false narrative about patient suicides in a backlash against the CDC guideline.

As a patient advocate who has been working with nonprofits for almost 20 years, I believe that the pharmaceutical industry should be giving money to the pain community to help us with tools and resources that make our lives better.

People think it’s easy for advocacy groups to get funding from Pharma, but that is not true, at least for the small funding that I was involved with. I know firsthand the many checks and balances that are needed before any grant money is provided. It did not matter if it was $100 or $10,000. Nonprofits have to account for it on their tax returns and through audits.

Since 2015, grant money from Pharma for iPain completely stopped, even the small amounts that we were getting. We went from completing over 200 grant applications a year, and getting less than 5 percent of them approved, down to a 0% success rate. There is nothing to report when you receive nothing, which is how it is going now for most patient advocacy organizations and support groups.

Receiving nothing from Pharma did not change our opinions or goals. We found other ways to accomplish them on a shoestring budget. I wish it was easier, but being hard does not stop the movement, because it is a matter of life or death in too many cases. Our work at iPain continued, because it was never about spreading whatever Pharma wanted. It was always about helping patients get individualized care. And all options, including opioids, should be on the table.  

Our work continued on a smaller scale and more creatively than if we had a large budget to get things done. At about the same time that our funding dried up, social media took off and it became easier to reach more people and actually be heard. We were still able to accomplish our goals, at less cost and with less funding.

I do not have the time, energy or space in this column to go into the many financial ties — disclosed and undisclosed — that Kolodny and PROP have with law firms involved in opioid litigation, which funded their efforts to take opioids away from patients. Good God, what is the point of him being so moral in his own eyes, that he does not let other people choose what is best for them?  

Patients losing access to treatment is real. So are patients dying or contemplating suicide. I receive emails and calls from them regularly, even since stepping down from iPain.

The first patient I lost due to being cut off from medication was in 2012. She was one of my best friends at the time. I talked to her often. She was on a medication that was helping. The provider cut her off and put her on a different drug. Neither were opioids. She was stable and doing well with the first medication, but not on the second one. My friend decided that jumping out of a 10-story window to her death would be better than not having the medication that was giving her more quality of life.

Kolodny says someone in acute withdrawal might kill themselves because it is so excruciating. Yes, Dr. Kolodny, withdrawal is hard and you are forcing it on people who are already in pain, who did not need or ask for your opinion. That is the real hoax.

Barby Ingle is a reality TV personality living with multiple rare and chronic diseases. She is a chronic pain educator, patient advocate, motivational speaker, and best-selling author on pain topics. Barby has received over 25 awards for her advocacy efforts over the years. You can follow her at www.barbyingle.com 

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. )

Report Warns of Million More Opioid Overdose Deaths

By Pat Anson, PNN Editor

A new report is warning that over a million more people will die of opioid overdoses in the U.S. and Canada by the end of the decade unless public health policies are prioritized to treat opioid addiction and marketing by pharmaceutical companies is prohibited.

“Unrestrained profit-seeking and regulatory failure instigated the opioid crisis 25 years ago, and since then, little has been done to stop it,” says Keith Humphreys, PhD, a Stanford psychiatry professor who chaired the Stanford-Lancet Commission on the North American Opioid Crisis. “Pharma companies are all being sued, and they deserve to be sued, but we have to remember they exploited weaknesses in our health care regulatory system that are still there.”

The commission’s report, published in The Lancet medical journal, projects that from 2020 to 2029, opioid deaths in the U.S. will reach 1.22 million if no action is taken.

The Stanford-Lancet commission lays most of the blame for the North American opioid crisis on the pharmaceutical industry, particularly Purdue Pharma’s heavy-handed promotion of OxyContin, as well as lax regulation by the Food and Drug Administration. The report calls for a ban on all direct-to-consumer drug advertising and for an end to pharmaceutical funding of continuing medical education programs.

The commission’s 50-page report was prepared by a panel of academics, clinicians and policymakers, including several longtime critics of opioid prescribing practices. They include Drs. Anna Lembke and David Juurlink, who are board members of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), and Erin Krebs, MD, a researcher who hosted a lecture series on opioid prescribing for the Steve Rummler Hope Foundation, which lobbies against the use of opioids. The Rummler foundation is the fiscal sponsor of PROP.

Humphreys is also a frequent critic of opioid prescribing. In 2018, he co-authored a controversial article that dismissed concerns that cutbacks in prescribing would be harmful to patients, saying that reducing the supply of opioids “may increase heroin use and reduce quality of life in the short term, but in the long term could generate positive health benefits.”

Humphreys’ commission took a more even-handed approach to opioids, saying the drugs “are in some cases of great benefit and in others very harmful” and that regulators should avoid “overly lax or overly restrictive prescribing policies, both of which have substantial potential for harm.”

But there is little discussion in the report of how opioid prescribing has already declined significantly in the U.S. and Canada, how it has harmed pain patients, or that the overdose crisis is now largely fueled by illicit fentanyl and other street drugs, not prescription opioids.

"The Stanford/Lancet report on the so-called opioid crisis is not only one-sided. It is fundamentally wrong on facts and deliberately slanted on interpretation. This is unsurprising, given the participation of several long-time anti-opioid zealots on its commission,” said patient advocate Richard “Red” Lawhern, PhD. 

"It is now well established from multiple published sources that over-prescription of pain relievers by physicians treating pain patients is not now and never has been a significant source of addiction or overdose-related mortality in the US.  Deaths solely due to prescription opioids are in fact quite rare. Overdose deaths are dominated by deaths due to poly-pharmacy, alcohol, and illegal street fentanyl.” 

The commission’s work was funded by Stanford University’s School of Medicine.

Does U.S. Have Opioid Crisis or Overdose Crisis?

By Pat Anson, PNN Editor

A lot of people were surprised by an alarming report from the CDC last week, showing that a record 100,306 Americans died of a drug overdose in the 12-month period ending in April, 2021. That’s a 28.5% increase in a single year.

Among those who were caught off-guard was Andrew Kolodny, MD, an opioid researcher at Brandeis University and founder of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

“I was surprised by the latest tally from the CDC showing that for the first time ever, the number of Americans who fatally overdosed over the course of a year surpassed 100,000,” Kolodny wrote in an op/ed for The Conversation that’s been republished in several major newspapers.

“The soaring death toll has been fueled by a much more dangerous black market opioid supply. Illicitly synthesized fentanyl – a potent and inexpensive opioid that has driven the rise in overdoses since it emerged in 2014 – is increasingly replacing heroin. Fentanyl and fentanyl analogs were responsible for almost two-thirds of the overdose deaths.”

It’s refreshing to see Kolodny finally address the elephant in the room – illicit fentanyl – instead of always blaming prescription opioids for America’s addiction and overdose problem. But he continues to frame the drug crisis as an “opioid crisis” when repeated studies show that multiple substances are usually involved in overdoses, including non-opioid drugs like cocaine and methamphetamine.  

“It is especially tragic that these deaths are mainly occurring in people with a disease – opioid addiction – that is both preventable and treatable. Most heroin users want to avoid fentanyl. But increasingly, the heroin they seek is mixed with fentanyl or what they purchase is just fentanyl without any heroin in the mix,” Kolodny wrote.

“Opioid-addicted individuals seeking prescription opioids instead of heroin have also been affected, because counterfeit pills made with fentanyl have become more common.”

Here Kolodny sidesteps the fact that many pain patients are turning to street drugs because of government and law enforcement policies that restrict the prescribing of opioid medication – policies that Kolodny and PROP had a significant role in creating. They’re not addicts “seeking prescription opioids instead of heroin.” They’re patients seeking pain relief.

“Our misdirected efforts to solve the overdose epidemic have led to even more deaths. As long as we myopically focus on reducing prescription opioids for people in pain, the overdose epidemic will continue and worsen,” says Lynn Webster, MD, a pain management expert, Senior Fellow at the Center for U.S. Policy (CUSP) and Chief Medical Officer of PainScript.  

“Some of those who need opioids will be driven to the streets where they will find illicit and, potentially, lethal opioids. Some people may even choose to end their own lives. Your readers may have seen the recent article that described a suit against a physician for denying opioid treatment of a patient. The patient committed suicide as a result.” 

Webster says it is wrong to single out opioids – legal or illicit – for America’s escalating drug problem when the causes are complex and embedded in society. 

“We do have an overdose epidemic. Unfortunately, policymakers and the media have wrongly categorized it as an opioid epidemic rather than a drug overdose epidemic,” says Webster. “The roots of the overdose crisis are deep and seeded in despair from major shifts in socioeconomic conditions and lack of adequate and affordable healthcare. The Covid pandemic has made clear that social and mental health issues must be addressed if the overdose crisis is to be reversed. 

“The only solution to the overdose epidemic is to lower the demand. This will require a broad approach that involves addressing socioeconomic and mental health drivers of demand. More affordable and accessible treatment is important but will not solve the crisis.” 

Invested in Opioid Crisis 

Changing the narrative about the overdose crisis won’t be easy, since so many lawyers, politicians, healthcare companies and media outlets have invested in perpetuating the “opioid crisis.” Kolodny and other PROP board members have lucrative side hustles testifying as expert witnesses in opioid litigation cases for plaintiff law firms, which stand to make billions of dollars in contingency fees if their lawsuits are successful. 

One such case was decided by a federal jury in Cleveland today, which found that Walgreens, CVS and Walmart substantially contributed to addiction and overdoses in two Ohio counties by dispensing opioids in their pharmacies. The companies said they would appeal. 

“Plaintiffs' attorneys sued Walmart in search of deep pockets while ignoring the real causes of the opioid crisis-such as pill mill doctors, illegal drugs, and regulators asleep at the switch,” Walmart said in a statement. “And they wrongly claimed pharmacists must second-guess doctors in a way the law never intended and many federal and state health regulators say interferes with the doctor-patient relationship.”

Judges in Oklahoma and California recently ruled that opioid manufacturers are not “public nuisances” and can’t be held responsible for what people ultimately do with their drugs.  

AMA: ‘Time to Change Course’ on Overdose Epidemic

By Pat Anson, PNN Editor

With the U.S. facing a record number of drug deaths, the American Medical Association is calling for major changes in the way healthcare providers, insurers, and state and federal policy makers combat the overdose epidemic.

“It’s time to change course,” the AMA says in a new report that documents a 44% decrease in opioid prescribing nationwide over the past decade. At the same time, however, overdose deaths continued rising, fueled primarily by illicit fentanyl, heroin, cocaine and other street drugs.

“With record-breaking numbers of overdose deaths across the country, these are actions policymakers and other stakeholders must take,” AMA President Gerald Harmon, MD, said in a statement. “The focus of our national efforts must shift. Until further action is taken, we are doing a great injustice to our patients with pain, those with a mental illness and those with a substance use disorder.”

The AMA report calls for the CDC to “restore compassionate care for patients with pain” by rescinding “arbitrary thresholds” for opioid doses recommended in the agency’s 2016 prescribing guideline.  Although voluntary and only intended for primary care providers treating chronic pain, the guideline has been widely adopted as a standard of care by states, insurers, pharmacies and physicians of all specialties.

Doctors have also made liberal use of Prescription Drug Monitoring Programs (PDMPs), looking for signs of patients “doctor shopping” or abusing their medications. The databases, which track prescriptions for opioids and other controlled substances, have been accessed 2.7 billion times by physicians, regulators and law enforcement since 2014. State PDMPs were utilized over 910 million times in 2020 alone, according to the AMA.  

As a result of these and other measures to limit opioid prescriptions, millions of pain patients have been tapered to lower doses or completely cutoff from opioids -- yet drug deaths continue rising.

From January, 2020 to January, 2021, over 94,000 Americans died of drug overdoses, the most ever over a 12-month period.

A recent study by the Reason Foundation found that PDMP’s may be making the opioid crisis worse by forcing legitimate patients to turn to street drugs because they lost access to pain medication.

SOURCE: AMA

“The nation’s drug overdose and death epidemic has never just been about prescription opioids,” said Harmon. “We use PDMPs as a tool, but they are not a panacea. Patients need policymakers, health insurance plans, national pharmacy chains and other stakeholders to change their focus and help us remove barriers to evidence-based care.”

One such barrier is limited access to addiction treatment. Although over 100,000 healthcare providers can now prescribe buprenorphine (Suboxone) for the treatment of opioid use disorder, the AMA estimates 80 to 90 percent of people with a substance abuse problem receive no treatment.

The AMA urged policymakers to take these steps:

• Ensure access to affordable treatment for patients with pain, including opioid therapy, by rescinding arbitrary laws and policies that restrict access to pain care.

• Stop insurers from using step therapy and prior authorization to deny or delay treatment for opioid use disorder and other needed medical care.

• Support harm reduction services such as needle and syringe exchange services.

• Make overdose reversal medications like naloxone available over the counter.

• Decriminalize fentanyl test strips and other drug checking supplies.

• Ensure settlement money from opioid litigation cases is used only for public health services.

• Remove structural barriers to healthcare in marginalized and minority communities.

• Improve databases to better track non-fatal overdoses, polysubstance use and local trends in drug use.

“To make meaningful progress towards ending this epidemic, a broad-based public health approach is required. This approach must balance patients’ needs for comprehensive pain management services, including access to non-opioid pain care as well as opioid analgesics when clinically appropriate, with efforts to promote appropriate prescribing, reduce diversion and misuse,” Harmon said.

In recent years, the AMA has become increasingly vocal about the declining quality of pain care in the U.S. and the CDC guideline in particular. In a recent letter to the CDC, the chair of the AMA board said patient stigma and the undertreatment of pain were “a direct result” of the 2016 guideline. The CDC is currently considering an update and possible expansion of the guideline, although a draft revision contains the same dose recommendations as the original guideline.  

“CDC’s threshold recommendations continue to be used against patients with pain to deny care. We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy,” wrote Bobby Mukkamala, MD, a Michigan surgeon.

The AMA’s opposition to the guideline drew a rebuke from the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP). In a February letter to the AMA, PROP’s board said opioid prescribing for pain was still problematic and “a common gateway to illicit opioid use.” The letter also said that opioid medication should only be used for short-term acute pain and end-of-life care.     

AMA: Pain Patients ‘Need To Be Treated as Individuals’

By Pat Anson, PNN Editor

The American Medical Association is once again calling on the CDC to scrap dosage limits and make other changes to its controversial 2016 opioid prescribing guideline.

In a letter sent Thursday to a top official at the CDC’s National Center for Injury Prevention and Control (NCIPC), the chair of the AMA’s board of trustees said pain sufferers “need to be treated as individuals” and should not be subject to dose limits. The CDC is currently preparing a revision and possible expansion of the guideline, a lengthy process that could take another year to complete.

“A revised CDC Guideline that continues to focus only on opioid prescribing will perpetuate the fallacy that, by restricting access to opioid analgesics, the nation’s overdose and death epidemic will end. We saw the consequences of this mindset in the aftermath of the 2016 Guideline. Physicians have reduced opioid prescribing by more than 44 percent since 2012, but the drug overdose epidemic has gotten worse,” wrote Bobby Mukkamala, MD, a Michigan surgeon and chair of the AMA board.

The CDC said last week that a record 93,331 Americans died of drug overdoses in 2020. Although the vast majority of those deaths involved illicit fentanyl, heroin and other street drugs, efforts at combating the overdose crisis continue to focus on patients, doctors and reduced opioid prescribing.

“Patients with pain continue to suffer from the undertreatment of pain and the stigma of having pain. This is a direct result of the arbitrary thresholds on dose and quantity contained in the 2016 CDC Guideline. More than 35 states and many health insurers, pharmacies, and pharmacy benefit managers made the CDC’s 2016 arbitrary dose and quantity thresholds hard law and inflexible policy,” said Mukkamala.

“CDC’s threshold recommendations continue to be used against patients with pain to deny care. We know that this has harmed patients with cancer, sickle cell disease, and those in hospice. The restrictive policies also fail patients who are stable on long-term opioid therapy.”

The AMA has been warning about the “inappropriate use” of the guideline since 2018, when its House of Delegates adopted resolutions calling for the elimination of dose thresholds based on morphine milligram equivalents (MME). The CDC guideline recommends that daily doses not exceed 90 MME, a dose that some patients consider inadequate for pain relief.  

Recommendations a ‘Rough Guide’

At a meeting last week of the CDC Board of Scientific Counselors, one of the authors of the 2016 guideline said the MME thresholds were only meant to be “a rough guide” for prescribers and shouldn’t been seen as “absolutes.”

“We heard the concerning reports about the misapplication of the 2016 guideline and we’ve learned from what happened. We know there is a very real possibility that, even with adjustments, the guideline update could be misused,” said Deborah Dowell, MD, Chief Medical Officer of NCIPC.

Critics might wonder if the agency has learned anything in the last five years. A preliminary draft of a revised guideline still contains dose thresholds, recommending that doctors “should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to >90 MME/day.”

An independent panel of outside advisors that reviewed the draft expressed concern about maintaining the dose thresholds, saying they would lead to more forced tapering of patients.

“Though workgroup members recognized the need to have thresholds as benchmarks, many felt that including these thresholds in the supporting text could serve to de-emphasize them as absolute thresholds, and thus recommended removing the specific MME range from the recommendation,” the Opioid Workgroup said in its final report to CDC.

The workgroup also warned that the current draft revision of the guideline was “not balanced” because it focuses heavily on the risks and potential harms of opioids, with less attention paid to their potential benefits. The AMA called on the CDC to adopt the workgroup’s recommendations.

“Patients with pain need the CDC to be their advocate and urge it to rescind the perceived limits on opioid therapy doses or days,” Mukkamala said in closing his letter.

Opioid Income Redistribution

That view is not shared by the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), which sent out a news release this week claiming that prescription opioids are largely responsible for the overdose epidemic.

“Tragically, prescription opioids still account for about 28% of all opioid-related deaths.  Prescription opioids also contribute to synthetic opioid deaths because many heroin and illicit fentanyl users developed their addiction from taking prescription opioids,” PROP claimed. ”Overprescribing of opioids continues to fuel this epidemic. Reducing new opioid prescriptions remains vitally important.”

At least four PROP board members, including founder Andrew Kolodny, MD, have testified as paid witnesses for plaintiff law firms involved in opioid litigation, making as much as $725 an hour. Those law firms stand to make billions of dollars in contingency fees as those cases near an end, with one recent settlement expected to result in a $26 billion jackpot for states, cities and counties. As PNN has reported, many of the lawyers involved in the cases are major political donors.

“Businesses can’t print cash, so where do politicians think the money for these payoffs will come from? The answer is customers in higher prices and workers in lower wages,” The Wall Street Journal said in an editorial.

“The opioid settlement is another example in a growing list of lawsuits that redistribute income from the larger society to rich plaintiff attorneys, who then help politicians with their campaign contributions, who then rehire the lawyers to help with more mass tort claims. Alas, it’s the American way.”

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.      

It’s Time for People in Pain To Be Heard

By Carol Levy, PNN Columnist

I just had my second “there's an issue with filling your codeine prescription” incident.

I have been on codeine, on and off, for over 30 years. Initially, I was allowed refills. When that was no longer permitted, my doctor gave me a new prescription, each and every month, for 120 pills.

When my trigeminal neuralgia pain became somewhat better as a result of various surgeries, I often took only 1 or 2 pills per day.

I am now about 90% housebound. Part of it is due to Covid, but mostly it’s because I do not want to go out and make the baseline pain worse. As a result, some days I take no codeine at all. My last prescription was for 120 pills. It was a month’s supply that lasted for 9 months.

The first incident was last year, when my pain management doctor decided, without discussing it with me, that he was no longer writing scripts for 120 codeine pills a month. Instead, he changed it to 10 pills a month.

I was told he didn’t like me having extra pills, a nonsensical excuse as I had no history of giving them away or taking too many. Prescriptions for 120 pills just made it easier for everyone, including the insurance company, since they would be paying less for fewer doctor appointments.

Fortunately, I was able to go to my family doctor, who had no problem writing for 120 pills. They trusted me there, knowing I would not abuse them.

But when I took the script to the pharmacy, I was told, “We can only fill a 7-day supply per your insurance company.”

The worst part about that was not that I would have to repeatedly go back to the pharmacy, but that the cost for each 7-day supply was much more for me out-of-pocket than if they just filled the whole prescription at once.

My Physician Assistant called the insurance company to ask for a pre-authorization. This would allow the pharmacy to fill the entire amount at one time. They immediately allowed it for the next 12 months, which seemed odd.

If they think I should only be getting a 7-day supply, then why allow the whole script to be filled for an entire year? Either I am untrustworthy or I'm not.

I am lucky. I don’t rely on daily opioids to get me out of bed, go to the store or be able to work. So many of us have no other option but to take them. My annoyance is tame compared to what other patients go through, who have been unable to get what they need due to restrictions on prescribing.

Physicians for Responsible Opioid Prescribing (PROP) recently sent a letter to the AMA saying the organization shouldn’t be calling for changes in the CDC opioid guideline, even though far more people are dying from street drugs than prescription opioids.

“Medically prescribed opioids remain a common gateway to illicit opioid use and are themselves frequent causes of opioid addiction and overdose, even if illicit opioids currently cause the greater number of deaths,” PROP said.

PROP founder Dr. Andrew Kolodny even said that prescriptions “still have a very long way to go” and should be reduced even further.

PROP’s reach is loud and strong. We complain so much to each other, patient support groups, Twitter and other social media about how awful this is, how unfair and inhumane.

A number of people have started online petitions to send to the FDA or CDC, asking that the guidelines be changed so they stop hurting chronic pain patients. Many say, “This is a great idea.” Yet few actually sign.

Nothing will change if we don’t band together and make our voices heard. The call keeps going out, “Something must be done!” But too often the answer is, “Oh yes, somebody must do something. But I'm too busy.”

Whispering in the wind won’t help. It is long past time for us to become a true force, with a voice that is louder and stronger than PROP’s. 

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.”  Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

New European Guideline Says Opioids ‘Do Not Work’ for Many Types of Chronic Pain

By Pat Anson, PNN Editor

Calling opioid medication a “two edged sword,” the European Pain Federation (EFIC) has released new guidelines that strongly recommend against using opioids to treat fibromyalgia, low back pain, migraine, irritable bowel syndrome and other types of chronic non-cancer pain.

“The new recommendations advise that opioids should not be prescribed for people with chronic primary pain as they do not work for these patients,” the EFIC said in a statement.

However, the guideline states that low doses of opioids may be suitable for treating “secondary pain syndromes” caused by surgery, trauma, disease or nerve damage, but only after exercise, meditation and other non-pharmacological therapies are tried first.

“Opioids should neither be embraced as a cure‐all nor shunned as universally dangerous and inappropriate for chronic noncancer pain. They should only be used for some selected chronic noncancer pain syndromes if established non‐pharmacological and pharmacological treatment options have failed,” the guideline states. “In this context alone, opioid therapy can be a useful tool in achieving and maintaining an optimal level of pain control in some patients.”

Opioid pain relievers are not as widely used in Europe as they are in the United States or Canada. The EFIC said it was trying to “allay concerns over an opioid crisis” developing in Europe, as it has in North America.       

“As the leading pain science organisation in Europe, it is crucial that EFIC sets the agenda on issues such as opioids, where there are growing societal concerns. These recommendations clarify what role opioids should play in chronic pain management,” EFIC President Brona Fullen said in a statement.

The guideline’s lead author, Professor Winfried Häuser, said he and his colleagues tried to strike a middle ground on the use of opioids.

“The debate on opioid-prescribing for chronic non-cancer pain has become polarized: opioids are either seen as a dangerous risk for all patients, leading to addiction and deaths, or they are promoted as most potent pain killers for any type of pain,” said Häuser, who is an internal medicine specialist in Germany.

“Opioids are still important in the management of chronic non-cancer pain – but only in some selected chronic pain syndromes and only if established non-pharmacological and non-opioids analgesics have failed or are not tolerated.”

PROP Consulted for European Guideline

The guideline was developed by a 17-member task force composed of European experts in pain management, including 9 delegates selected by EFIC’s board “who advocate and who are critical with the use of opioids.” Only one delegate from Pain Alliance Europe represented patients.

The recommendations developed by the task force were reviewed by five outside experts, including Drs. Jane Ballantyne and Mark Sullivan, who belong to Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group in the U.S.  Ballantyne is PROP’s President, while Sullivan is a PROP board member. Several changes suggested by the outside experts were adopted.

Coincidentally, Ballantyne, Sullivan and three other PROP board members were involved in the drafting of the opioid guideline released in 2016 by the U.S. Centers for Disease Control and Prevention. That controversial guideline is now being rewritten by the CDC after voluminous complaints from patients and doctors that the recommendations led to forced tapering, withdrawal, uncontrolled pain and suicides.

Sullivan and two other PROP board members were also involved in drafting Canada’s 2017 opioid guideline, which was modeled after the CDC’s and provoked similar complaints from Canadian pain patients.

90 MME Recommended Limit

The CDC and Canadian opioid guidelines appear to have been used as resources by the EFIC task force, which adopted many of the same recommendations, even while acknowledging the low quality of evidence used to support them.   

One recommendation is straight out of the CDC guideline, advising European doctors to “start low and go slow.” Prescribers are urged to start patients on low doses of 50 morphine milligram equivalents (MME) or less a day and to avoid increasing the dosage above 90 MME/day.

One significant difference with the North American guidelines is that the EFIC recommends that opioids not be prescribed for fibromyalgia, migraines and other chronic “primary pain” conditions for which there is no known cause – suggesting those disorders have an emotional or psychological element that will lead to opioid abuse.

“Prescription of high doses of opioids to patients with primary pain syndromes might have been a factor driving the opioid crisis in North America,” the EFIC guideline warns.

“This was further compounded by patient characteristics that included physical and psychological trauma, social disadvantage and hopelessness that served as a trigger for reports of pain intensity prompting prescriptions of more opioids.”

Secondary pain conditions for which opioids “can be considered“ include multiple sclerosis, stroke, restless leg syndrome, Parkinson’s disease, rheumatoid arthritis, phantom limb pain, non-diabetic neuropathy, spinal cord injuries and Complex Regional Pain Syndrome (CRPS). 

Unlike the North American guidelines, the EFIC acknowledges that there are physical and genetic differences between patients. Some patients who are rapid metabolizers “might require higher dosages of opioids than the ones recommended by the guidelines.“

EFIC GRAPHIC

The EFIC also warns that its guideline should not be used to justify abruptly tapering or discontinuing opioids for anyone already prescribed at higher dosages. The recommendations are also not intended for the management of short-term acute pain, sickle cell disease or end-of-life care.

AMA Scolded for Seeking Changes in CDC Opioid Guideline

By Pat Anson, PNN Editor

Eight months after the American Medical Association told the CDC that its controversial opioid guideline has “harmed many patients” and needs to be revised, an anti-opioid activist group has accused the AMA of employing false moral arguments to justify using opioid medication to relieve human suffering.

The letter from Physicians for Responsible Opioid Prescribing (PROP) to AMA President Susan Bailey, MD, takes issue with the AMA’s position that the U.S. “no longer has a prescription opioid epidemic” and instead faces an overdose crisis fueled by illicit fentanyl and other street drugs.

“These statements send a strong message that opioid prescribing for pain is no longer problematic, and that the CDC’s recommended guardrails are no longer needed. Nothing could be further from the truth,” says the PROP letter, which was signed by the organization’s board of directors.

“There is compelling evidence that many of those currently struggling with opioid dependence and addiction were introduced to opioids through use of medically prescribed opioids used to treat chronic pain. Medically prescribed opioids remain a common gateway to illicit opioid use and are themselves frequent causes of opioid addiction and overdose, even if illicit opioids currently cause the greater number of deaths.”

The CDC’s 2016 guideline was only intended for primary care physicians treating chronic pain, but its voluntary recommendations on opioid prescribing have been widely adopted as policy by federal agencies, states, insurers, pharmacies and doctors of all specialties. The guideline has not only failed to reduce drug deaths – which now stand at record highs – but federal health experts admit that widespread misuse of the guideline has caused “serious harm” to patients, including forced tapering, withdrawal, uncontrolled pain and suicide.    

PROP’s letter to the AMA goes even further than the CDC recommendations, suggesting that opioid medications should only be used for short-term acute pain and end-of-life care.  

“All moral, ethical, regulatory, legal and political arguments that opioids are needed so that people do not suffer needlessly should apply specifically to short-term pain management where there is proven benefit, and not to long term pain management where evidence of benefit is largely anecdotal, and there is compelling evidence of harm,” PROP said.

“Why then is the AMA applying the moral argument to the false premise that people will suffer needlessly if they do not have unrestricted access to opioids? By all means apply moral arguments and principles to make sure opioids are available for the right indications, but it makes no sense at all to suggest that removing guidance on opioid dose and duration is needed so that people with chronic pain do not suffer.”

AMA: ‘Misguided Focus’ on Opioids Harms Patients

To be clear, opioid addiction is rare in patients and the AMA never said that people should have “unrestricted access to opioids.” The AMA called for balanced and individualized care based on patient need, not one-size-fits-all guidelines that dictate dosages or the type of treatment everyone should get.    

In a February 19th letter to PROP, AMA President Dr. Susan Bailey said the group mischaracterized the AMA’s position on opioid treatment.

“When policies or organizations focus only on the restriction of a legitimate pharmacologic option to help patients with pain, they miss the chance to address the complexity of policies needed to truly help patients with pain. That misguided focus also has led to harmful stigmatization and other stressors,” Bailey said.

“That is why the AMA provided comprehensive recommendations on the 2016 CDC Guideline and why we continue to advocate for policies that support comprehensive, multidisciplinary, multimodal pain care, including opioid therapy when appropriate.”

“Patients with chronic pain and patients with substance use disorder both need access to multimodal treatments for their medical care,” said Dr. Chad Kollas, a palliative care specialist who is an AMA delegate and Secretary of American Academy of Hospice and Palliative Medicine (AAHPM).

“AMA and AAHPM have recognized the importance of pursuing balanced opioid policy, policy that protects access to opioid analgesics for patients with medically legitimate needs for those medications, while also protecting the public safety and reducing potential harms of prescribed medications.”

Kollas said PROP’s belated response to the AMA’s position may be an attempt to deflect attention away from a recent report that found deaths due to illicit fentanyl soaring, while overdoses involving prescription opioids remained flat.  The research adds to a growing body of evidence suggesting the CDC opioid guideline was ineffective and misdirected.

Although opioid prescribing is at 20-year lows, PROP founder Dr. Andrew Kolodny has said prescriptions “still have a very long way to go” and should be reduced even further. Kolodny recently advised the World Health Organization in the development of a new guideline for treating chronic pain in children, which recommends that opioids only be given to children who are dying or in palliative care.

Slow Progress on Guideline Update

Faced with growing criticism of its own guideline, the CDC announced in 2019 that it was working on an update or possible expansion of its recommendations. Progress has been slow since then.  An advisory group appointed by the agency last summer has had only two preliminary meetings and will not review suggested changes to the guideline until next month, according to an update given Tuesday to the CDC’s Board of Scientific Counselors (BSC).

Draft guidelines are not expected to be available for public comment until the end of this year, meaning any revisions will likely not be finalized until 2022. Patient advocates told the BSC they were disappointed by the lack of progress.

“I would like to urge the members of this panel to please take seriously the issue of timely revision of the CDC guidelines for chronic pain. We have a catastrophe welling out across the country in a wholly marginalized and invisible group. On top of that, we are losing working physicians at a steady rate,” said Terri Lewis, PhD, a patient advocate and rehabilitation specialist. “Everybody is in the gun sights of policy that is not working for anybody. I beg you to please make this an urgent priority.”

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 Plans to Hire New Executive Director

By Pat Anson, PNN Editor

An influential anti-opioid activist group -- Physicians for Responsible Opioid Prescribing (PROP) – is raising money to hire a new Executive Director to replace Dr. Andrew Kolodny, PNN has learned.

There is no indication that Kolodny is leaving PROP, a volunteer organization that he founded in 2011 to “turn the tide of opioid overprescribing.” But in an unsigned email sent to supporters this week, PROP asked for donations so it could hire a new Executive Director, a position long held by Kolodny.

“We’ve retrenched and brainstormed and have great plans to expand our reach and impact. Our next big step is to hire a paid staff person. Will you help to make this plan a reality? We are trying to raise $100,000 by December 31st to ensure that we can hire an executive director with resources to take PROP's work to the next level. Please help by donating what you can,” the email said.

Supporters who click the donate button on the email will be taken to a PayPal account operated by the Steve Rummler Hope Foundation, which is PROP’s “fiscal sponsor.” PROP is not a charity, but can collect tax deductible donations under the foundation’s non-profit status.

Like PROP, the Rummler foundation’s main goal is to reduce opioid prescribing. Kolodny works closely with the organization and serves on its Medical Advisory Committee, along with PROP President Dr. Jane Ballantyne.   

Kolodny declined to talk with this reporter about what his future role with PROP will be.

“I haven’t had a good experience answering questions from you in the past, so I’m not going to talk with you,” Kolodny told me in a brief phone call.

‘Heroin Pills’

It would be hard to overstate the influence that Kolodny and PROP have had on opioid prescribing in the United States. A psychiatrist who specializes in addiction treatment and former Chief Medical Officer at Phoenix House, Kolodny is the public face of PROP. He lobbied Congress and federal health agencies for years to limit opioid prescribing, and gives frequent media interviews on opioid-related issues.

In a 2015 C-SPAN interview, Kolodny called opioid painkillers “heroin pills” and suggested pain patients shouldn’t trust their own doctors.  

“I wish I could tell you that you should trust your doctor and talk to your doctor about this, but that may not be the case,” he said. “We have doctors even prescribing to teenagers and parents not recognizing that the doctor has just essentially prescribed the teenager the equivalent of a heroin pill.”

PROP achieved its greatest success in 2016, when the CDC released its controversial opioid prescribing guideline, which several PROP members helped draft. Although voluntary, the guideline was soon adopted as mandatory policy by many states, insurers, law enforcement and health organizations

DR. ANDREW KOLODNY

Opioid prescriptions were declining even before the guideline was released and now stand at their lowest level in over a decade. But overdoses keep rising, fueled largely by illicit fentanyl and other street drugs, not pain medication.

PROP’s fundraising pitch takes credit for the decline in prescriptions and doesn’t even mention the role of street drugs in the overdose epidemic.

“PROP has helped turn the tide of opioid overprescribing.The good news is that opioid prescribing has decreased. The bad news is that the US still leads the world in opioid consumption, drug companies continue to undermine progress, and -- since the SARS CoV-2 pandemic -- opioid overdose deaths are on the rise again while prescription opioid use remains a route to opioid addiction and death,” the PROP email states.

‘Killer Kolodny’

Kolodny has drawn the ire of many pain patients, who blame him for their increased suffering, loss of access to opioids, and anecdotal evidence of a rising number of suicides in the pain community.  A small group of patient advocates recently staged a “Killer Kolodny Rally” outside Brandeis University, where he co-directs opioid research at the Heller School for Policy and Management.   

Kolodny dismissed the rally, telling the Brandeis student newspaper that the protestors who want him fired worked for the opioid industry or had fallen under its sway, and were “trying to controversialize science.”      

“There were climate change scientists who were similarly attacked and their universities stood by them, and I think that Brandeis would stand by science,” Kolodny said. 

Many pain patients believe Kolodny has enriched himself by promoting the use of Suboxone, an addiction treatment drug. That unproven allegation led Kolodny to ask for and receive a letter from Indivior, Suboxone’s manufacturer, stating that he does not have a financial interest in the company.    

As PNN has reported, Kolodny has made a substantial amount of money working as a consultant and expert witness for law firms involved in opioid litigation. During Oklahoma’s lawsuit against Johnson & Johnson, Kolodny testified that he was being paid $725 an hour and would collect up to $500,000 for his services in that trial alone.  

Kolodny has not always been upfront about who is paying him. Last year he revised his conflict of interest statements on two medical journal articles to include his work in malpractice lawsuits. The articles were co-authored with former CDC director Thomas Frieden.

CDC Appoints New Opioid Workgroup for Guideline Update

By Pat Anson, PNN Editor

The Centers for Disease Control and Prevention has named a diverse group of physicians, academics and patients to an “Opioid Workgroup” that will advise the agency as it works on an update and possible expansion of its controversial opioid prescribing guideline. Several advisors on the 23-member workgroup also advised the agency during the 2015-2016 guideline process.

Notably lacking on the new panel are any members of Physicians for Responsible Opioid Prescribing (PROP), a small but influential group of radical anti-opioid activists who played an outsized role in drafting the original guideline.

Although voluntary and only intended for primary care physicians treating chronic pain, the guideline’s recommended limits on opioid prescribing were quickly adopted as policy by other federal agencies, dozens of states, insurers, pharmacies and doctors of all specialties.  As a result, many pain patients who took opioids safely for years were cutoff or tapered to lower doses, leading to uncontrolled pain, withdrawal and, in some cases, suicide.

Not until last year did the CDC publicly acknowledge the “misapplication” of the guideline and promise to make changes – although the process is unfolding slowly. An update to the guideline is not expected until late 2021, nearly six years after the initial guideline was released. It is expected to include new recommendations for the treatment of acute, short-term pain.  

‘Opioids Gave Me a Life’

There are two pain patients in the workgroup, who have contrasting experiences with opioid medication.

One is Kate Nicholson, a civil rights lawyer and patient advocate who took opioids for several years while disabled with severe back pain. Nicholson declined to talk with this reporter about her appointment to the workgroup, but shared her personal experience with the medical use of opioids in a 2017 PNN guest column.

“As soon as I took opioids, I improved. I wasn’t foggy or especially euphoric. In fact, the opposite happened, space opened in my mind and I could work again.  I also never developed a tolerance, requiring more medication for the same level of pain relief,” Nicholson wrote. “Opioids did not heal me. Integrative treatment over a long period of time did.  But opioids gave me a life until I could find my way to healing. Importantly, they allowed me to continue to work.”  

In a 2019 op/ed in The Los Angeles Times, Nicholson said the CDC guidelines should be revised because they were being treated  as “one-size-fits-all mandates” that were harmful to patients.

“The agency needs to revise its guidelines to recommend that physicians not abandon pain patients or engage in ‘forced tapering.’ The CDC should also study and address any unintended consequences of its 2016 guidelines, as it promised to do,” she wrote.

The other patient on the panel is Travis Rieder, PhD, Director of the Bioethics Masters Program at Johns Hopkins University. Rieder severely injured his foot in a motorcycle accident in 2015 and became dependent on opioids while recovering from surgery.

Rieder has written a book and several articles on his experience with chronic pain and the difficulty he had getting off opioids. He also became frustrated with the healthcare system and how it often abandons patients to pain, addiction or both.

“I represented one of the medical community’s most distressing dilemmas: a patient in obvious severe pain but begging for medication that is killing tens of thousands of people a year. The fact that different doctors, in different moments, treated me in radically different ways is completely unsurprising. Because no amount of public hand-wringing or blunt policy tools is going to make it clear what to do with patients like me. We’re a problem, and there’s no obvious solution,” Rieder wrote in his book, “In Pain: A Bioethicist’s Personal Struggle with Opioids.”

‘Clear Need’ for More Specific Guidelines

The other 18 members of the workgroup bring a mix of mostly academic and medical experience to the table.

At least five members of the panel advised the CDC during the drafting the 2016 guideline. They include the chair of the workgroup, Christina Porucznik, PhD, a professor of public health at the University of Utah, who chaired the opioid workgroup in 2016. Chinazo Cunningham, MD, Anne Burns, RPh, and Mark Wallace, MD, are also returning members of the workgroup. They are joined by Jeanmarie Perrone, MD, was a peer reviewer for the 2016 guideline.

In 2018, Perrone called for even more prescribing guidelines.

“There is a clear need for further impactful guidelines similar to the CDC guidelines that outline more specific opioid and non-opioid prescribing by diagnosis," said Perrone, a professor of Emergency Medicine and director of Medical Toxicology at Penn Medicine.

A new addition to the workgroup is Beth Darnall, PhD, a pain psychologist at Stanford University, who has drawn some controversy in the pain community for her studies about “catastrophizing” — a clinical term used to describe patients who are anxious, angry or feel helpless about their pain. She recently began an effort to find another term for catastrophizing.

Darnall, who has advocated against forced opioid tapering, expressed concern about the misapplication of the CDC guideline in a 2019 op/ed published by The Hill.

“Health-care organizations and states have cited the CDC guideline as a basis for policies and laws that extend well beyond its intended purpose. The guideline has been wrongly cited to substantiate proposed dose-based opioid prescribing policies that fail to account for the medical circumstances of the individual patient,” wrote Darnall. “We need flexible policies that provide meaningful access to comprehensive pain care and do not myopically focus on opioid dose reduction policies.”

‘Vast Improvement’ Over Previous Workgroup

The fact that we even know who is on the new workgroup is a small step forward in transparency for the CDC, which refused to disclose the names of any of its advisors when a draft version of the opioid guideline was released in 2015.

Only when threatened with a lawsuit and a congressional investigation did the CDC make the names public. They included Dr. Jane Ballantyne, President of PROP, along with PROP board members Dr. Gary Franklin and Dr. David Tauben. PROP founder and Executive Director Dr. Andrew Kolodny and PROP member Dr. David Juurlink also participated in a “Stakeholder Review Group” for the CDC.

“This group is a vast improvement over the 2016 Guideline group. There are several people here who I know, and who I trust to act as strong patient advocates,” said Bob Twillman, PhD, former Executive Director of the Academy of Integrative Pain Management. “All in all, this is a much better panel, and I'm confident it will produce a much better result for people with pain.”

Twillman cited Burns, Darnall, Wallace and Christine Goertz as workgroup members who would “keep patients in the center of the discussion.”

“The only other member I really know is Jeanmarie Perrone, who, while not a member of PROP, certainly could be. She and I have shared presentation opportunities a couple of times before, and she is very much in the anti-opioid crowd,” said Twillman.

“The new Workgroup constitutes a major improvement over the workgroup involved in drafting the 2016 guideline. That group included a number of well-connected people passionately opposed to the use of opioids in management of chronic pain,” said Stephen Nadeau, MD, a professor of Neurology at the University of Florida College of Medicine.

“Although the new Workgroup membership does not include such people, one could well question the inclusion of several people academically invested in pharmacological or non-pharmacological alternatives to opioid treatment, particularly in the complete absence of comparative effectiveness studies of such treatments.  One could also question the inclusion of surgeons, emergency room physicians, and pharmacists, who do not manage chronic pain.”

More Stakeholders Sought

CDC is seeking additional input from pain patients, caretakers and healthcare providers who will serve as “stakeholders” during the guideline development process. The agency is planning to speak with 100 stakeholders by phone or online for 45-60 minutes “to listen to personal perspectives and experience” related to pain care. The CDC has already obtained written comments from nearly 5,400 people, most of them pain patients.

If you’re interested in being a stakeholder, further information can be found here. The CDC is taking applications until August 21.

The CDC has also funded a series of new studies on opioid and non-opioid treatments for chronic pain. The report on opioids was released in April by the Agency for Healthcare Research and Quality. It concluded that opioids were no more effective in treating pain than nonopioid medication, and that long-term use of opioids increases the risk of abuse, addiction and overdose. At least three PROP members served as experts and peer reviewers during the drafting of that report.