Opioid Critics and Law Firms Profiting From Litigation

By Pat Anson, PNN Editor

Dr. Andrew Kolodny has long been known as one of the most strident critics of opioid prescribing. The founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP) has claimed that drug makers and a web of industry-funded groups are to blame for the nation’s addiction and overdose crisis.

Kolodny has accused the so-called “opioid lobby” of undermining the CDC opioid guideline, claimed pain patients are being “effectively manipulated” by drug makers, and called the American Cancer Society a “shady organization” because it accepts outside funding. 

Kolodny even spoke about an “opioid mafia” as he testified as an expert witness in Oklahoma’s opioid lawsuit against Johnson & Johnson.

“We’ve seen Johnson & Johnson promote opioids in this unbranded campaign, funding front groups, patient groups meant to look like grassroots organizations that promoted opioids, funding professional groups that were promoting opioids,” Kolodny testified.  

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“We know that Johnson & Johnson participated in the Pain Care Forum, a group that I have referred to as the opioid mafia, working to protect their stake in the opium supply into the United States.”

Kolodny’s hyperbole is catnip to compliant reporters who can usually count on him to return their calls and provide a good quote.  A psychiatrist and former chief medical officer for the addiction treatment chain Phoenix House, Kolodny is the go-to source for many news organizations covering the opioid crisis. He now co-directs an opioid research program at Brandeis University that is funded by a federal grant.

Kolodny’s has long maintained that he is free of any conflicts of interest and that PROP has never accepted funding from the pharmaceutical industry.

“I don’t believe physicians should be helping drug companies market their products,” he testified in Oklahoma. “It’s very easy to fool yourself when it’s profitable to fool yourself.”

It’s very easy to fool yourself when it’s profitable to fool yourself.
— Dr. Andrew Kolodny

Kolodny has been questioned for several days by lawyers for Johnson & Johnson, who have opened a window into a lucrative sideline he’s developed working as a paid consultant and expert witness. Kolodny stands to make upwards of half a million dollars working for the law firm of Nix Patterson & Roach, one of three outside law firms hired by Oklahoma Attorney General Mike Hunter to handle the case against Johnson & Johnson.

Kolodny testified that he’s being paid $725 an hour by Nix Patterson and could collect up to $500,000 for his services – possibly even more, depending on the length of the Oklahoma trial.

Under questioning, Kolodny also acknowledged that he was paid $725 an hour as a consultant for at least one other law firm involved in opioid litigation.

“I don’t think it should be a secret that I’m being compensated,” Koldony said, adding that he worked for Nix Patterson about ten hours a week before the trial started and 40 hours a week since it began four weeks ago. At his hourly rate, Kolodny’s weekly pay would be $29,000.

Nix Patterson can easily afford to pay Kolodny. According to the terms of their contingency agreement with Oklahoma, the three law firms stand to collect up to 25% of any damages and penalties. With $10 billion being sought from Johnson & Johnson, Nix Patterson’s share could theoretically add up to over $1.4 billion. 

Purdue Pharma and Teva Pharmaceuticals have already settled out-of-court with Oklahoma for far less — $270 million and $85 million respectively.  Nix Patterson’s share of the Purdue settlement alone was $31.6 million.

Compensation Not Disclosed

Koldony’s work as an expert witness in opioid litigation is not disclosed on Brandeis University’s website, PROP’s website or on the website of the Steve Rummler Hope Network, a non-profit that is the “fiscal sponsor” of PROP.  

A non-profit fiscal sponsorship is an IRS loophole that allows the Rummler Hope Network to collect tax deductible donations on PROP’s behalf. The identity of PROP’s donors and the size of their donations have never been disclosed.

Kolodny’s work in opioid litigation was not disclosed in a 2017 research study he co-authored that was published in JAMA Internal Medicine (ironically a study about conflict-of-interest), nor is it disclosed in an op/ed in JAMA that he co-authored that same year with former CDC director Thomas Frieden, MD.

Kolodny serves on the medical advisory committee of the Rummler Hope Network, along with PROP President Jane Ballantyne, MD. Coincidentally, Ballantyne worked as a paid consultant for Cohen Milstein Sellers & Toll – another law firm involved in opioid litigation in New Jersey, Indiana, Vermont, California and Illinois.

Kolodny testified in the Oklahoma trial that he also did some consulting for Cohen Milstein, which The New York Times profiled in 2014 as a politically influential law firm that was aggressively laying the groundwork for opioid lawsuits. We were unable to verify whether Kolodny was paid by Cohen Milstein or anything else about his work in opioid litigation.

“I’m not interested in answering any questions or talking to you,” Kolodny told this reporter.

PharmedOUT’s Paid Expert Witness

Another vocal critic of opioid prescribing is Dr. Adriane Fugh-Berman, Director of PharmedOUT, a program at Georgetown University Medical Center that seeks to expose deceptive marketing practices in the healthcare industry.

In a recent column in STAT News, Fugh-Berman and two of her grad students echoed many of Kolodony’s complaints about opioid manufacturers — claiming that “industry-funded attacks” on the CDC guideline by physician and patient advocacy groups were eroding public health.   

“The eerily similar attacks on the guideline… raise the question of whether this is a coordinated attempt by opioid manufacturers to use third parties to undermine, discredit, and smear the guideline,” they wrote. “There’s certainly a credible motive for opioid manufacturers to do this: The CDC guideline is an effective, evidence-based tool that has helped decrease inappropriate and dangerous prescribing of opioids for chronic pain patients.”

DR. ADRIANE FUGH-BERMAN

DR. ADRIANE FUGH-BERMAN

Unlike Kolodny, Fugh-Berman does disclose on PharmedOUT’s website that she is “a paid expert witness.” It is not clear, however, which law firm Fugh-Berman works for or what cases she is working on.

After initially agreeing to a telephone interview with PNN, Fugh-Berman abruptly cancelled. She did answer a few questions by email.

“I am a paid expert witness at the request of plaintiffs in litigation regarding pharmaceutical and medical device marketing practices, including litigation brought by several states and cities against opioid manufacturers.  My expert witness work has been disclosed to Georgetown, in my publications, and on our website,” Fugh-Berman wrote.

Like PROP, PharmedOUT does not disclose it donors, which Fugh-Berman calls “a common practice.”

“(We) are funded primarily by individual donations, mostly small donations but we have several major donors. We do not provide the names of our individual donors,” she said.

Fugh-Berman did disclose that Kaiser Permanente sponsored PharmedOUT’s recent opioid conference, which featured a speech by Kolodny entitled “How the Opioid Lobby Protected the Status Quo” and a talk by a Kaiser doctor on “How Kaiser Permanente Promotes Rational Prescribing.”  

Lobbying and Campaign Donations

Law firms involved in opioid litigation have played a significant role in some political campaigns and in shaping news coverage of the opioid crisis. The national firm of Simmons Hanly Conroy — which claims to have “effectively invented large-scale, multi-defendant opioid litigation” — represents dozens of states, counties and cities that are suing drug companies. According to reports, Simmons Hanly’s contingency fee will be as high as one-third of the proceeds from opioid settlements.

In the 2018 congressional election, Simmons Hanly spent nearly $1.2 million on lobbying and donated over $1 million to candidates, according to Open Secrets.org. Missouri Sen. Claire McCaskill (D) received five times more than any other candidate — nearly $410,000 — from donors affiliated with Simmons Hanly.

In February of that year, McCaskill released a scathing report that was sharply critical of physician and patient advocacy groups for accepting money from opioid manufacturers. At least two organizations cited in the McCaskill report — the American Academy of Pain Medicine and the American Pain Society — are named as defendants in opioid lawsuits filed by Simmons Hanly.

The report made headlines for McCaskill, who ultimately lost her bid for re-election, but continues to make news today — most recently in the STAT news column written by paid expert witness Dr. Fugh-Berman.

With the Oklahoma trial now heading into its fifth week, enormous amounts of money are at stake. A verdict against Johnson & Johnson could lead to a cascade of settlements in hundreds of other opioid lawsuits that could cost the pharmaceutical industry up to $50 billion. States, cities and counties would certainly benefit from a settlement of that size. So would the law firms that represent them – and their expert witnesses.

Forced Opioid Tapering: ‘The Next Great Experiment’

By Pat Anson, PNN Editor

Last month the Food and Drug Administration warned doctors not to abruptly discontinue or rapidly taper patients on opioid pain medication. The agency said it had received reports of “serious harm” to patients who’ve been suddenly cutoff, including withdrawal symptoms, uncontrolled pain, psychological distress and suicide.  

A new study published in the Journal of Substance Abuse Treatment shows just how common the practice is. And how millions of pain patients are being subjected to a public health experiment with hardly anyone keeping track of what happens to them.

“The United States went through a great ‘experiment’ of expanding treatment of pain with opioids which has proved to be disastrous for public health. We have entered the next great ‘experiment’ of discontinuing opioid medications among the millions of Americans who are currently taking them,” said lead author Tami Mark, PhD, senior director of behavioral health at RTI International, a non-profit research institute.

“Little is known about how many individuals are tapering off opioid medications, whether observed tapering follows any… guidelines, and the extent to which rapid tapering is associated with negative consequences.”

Mark and her colleagues looked at medical and pharmacy claims for nearly 500 Medicaid patients in Vermont who had high doses of opioid medication discontinued from 2013 to 2017.

All of the patients were prescribed a daily dose of at least 120 MME (morphine milligram equivalent) and over half had been on that high dose for over a year. 

Although most clinical guidelines recommend a “go slow” approach to opioid tapering – especially for patients on high doses – only 5 percent of the Vermont patients had a tapering period longer than 90 days. The vast majority (86%) were rapidly tapered in 21 days or less, including about half who were cut off from opioids without any tapering.

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The Centers for Disease Control and Prevention recommends that patients on opioids be tapered only 10% a week, with even slower tapers of 10% a month for long-term users. Had those guidelines been applied in Vermont, most tapers would have taken up to a year to complete.

Half of Tapered Patients Hospitalized

What happened to the patients who were cut off? Nearly half were hospitalized or had an emergency room visit for an “opioid-related adverse event” -- a medical code that can mean anything from severe withdrawal symptoms to acute respiratory failure. For tapered patients, the risk of being hospitalized was reduced by 7% for each additional week of tapering.

Researchers don’t know how many of the discontinued patients committed suicide or how many were referred to addiction treatment. Notably, less than one percent received medication assistance treatment (MAT) such as Suboxone.

The study did not look at why patients were taken off opioids or who initiated the discontinuation. But researchers believe some of the rapid discontinuations “may be due to a breakdown in the clinical relationship between physicians and patients” – suggesting the patients were forcibly tapered or abandoned by their doctors.

In its warning to doctors, the FDA strongly recommends that patients not be forcibly tapered and that patients and doctors should jointly agree to a tapering plan.

“Health care professionals should not abruptly discontinue opioids in a patient who is physically dependent. When you and your patient have agreed to taper the dose of opioid analgesic, consider a variety of factors, including the dose of the drug, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. No standard opioid tapering schedule exists that is suitable for all patients,” the FDA said.

Forced Tapering Widespread

How many patients have been forcibly tapered or discontinued is unclear, but it probably runs in the millions. A recent report from IQVIA found that there were 75 million fewer opioid prescriptions filled last year compared to 2014, with the biggest decline in high dose prescriptions. 

In PNN’s recent survey of nearly 6,000 pain patients, over 80 percent said they had been taken off opioids or had their dose reduced since the CDC released its controversial opioid guideline in 2016. Many were turning to other substances – both legal and illegal – for pain relief. And nearly half said they had considered suicide because their pain is poorly treated.

“I have been forced to taper to 90 MME. I had been stable and functional for 10 years at 135 MME. Now I can no longer work, and can barely take care of my children. I am considering suicide because my pain is unbearable,” one patient told us.

“I have been forcibly tapered by more than half and my pain is not being relieved at this dose. I am now unable to work or care for my children,” another patient wrote. “I live in constant anxiety (which worsens my pain) that I will be abandoned, refused any pain management, or reduced to a dose so low that taking my own life is the only way to escape the pain.”

“My forced taper was a little over a year ago. Before that I lived a small but functional life on high dose opioids. I took the same dose, from the same doctor for over a decade. Then I was forced off of 75% of my dose,” said another patient. “Once we got down to my current dose the medication was no longer enough to control my pain. I now live a tiny, nonfunctional life. I spend all my time in bed watching TV. I never leave the house. Showers are my worst enemy. And I am lucky. I wasn’t abandoned by my doctor.”

A noted critic of opioid prescribing calls reports like these exaggerations. Andrew Kolodny, MD, the Executive Director and founder of Physicians for Responsible Opioid Prescribing (PROP), told Stateline that the number of doctors who are inappropriately tapering patients is likely very small and should not be blamed on the CDC.

"We have a very real problem in this country. But the CDC guidelines didn't cause it," Kolodny said. "The problem is that millions of Americans have been put on round-the-clock opioids at very high doses and for reasons that doctors now realize were not appropriate.

"What the FDA needs to tell doctors is that because it is so excruciating to come off of opioids, they need to be very selective about who they put on them.”

In a series of Tweets two years ago, Kolodny said patients on high doses should be forcibly tapered “even if patient refuses” and challenged assertions that forced tapering was risky and widespread.

Now Kolodny says he sympathizes with patients but claims they are being manipulated.

“Their emotions are real. But they’re being effectively manipulated to controversialize the CDC guidelines,” he told Stateline.

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Many of Kolodny’s colleagues disagree. Over 300 healthcare professionals warned in a joint letter last year that forced opioid tapering has led to “an alarming increase in reports of patient suffering and suicides” and called for an urgent review of tapering policies at every level of healthcare.

“This is a large-scale humanitarian issue,” the letter warns. “New and grave risks now exist because of forced opioid tapering.” 

Recall of High Dose Opioids Proposed in Canada

Marvin Ross, Guest Columnist

A citizen’s petition filed last year by Physicians for Responsible Opioid Prescribing (PROP) and other anti-opioid activists tried to get the FDA to ban high-dose opioid medications. Although the FDA has yet to decide on the petition’s merits, the very same proposal is now being made in Canada in an editorial in the Canadian Medical Association Journal (CMAJ).

Dr. David Juurlink, a Toronto physician and board member of PROP, penned the editorial with Matthew Herder, a lawyer from Dalhousie University in Halifax, Nova Scotia. They claim that high dose pills – such as those containing 100mg of morphine or 80mg of oxycodone -- are too risky and should be pulled off the market.

"There is little sign that the (opioid) crisis is abating in Canada," they wrote. "Ministerial recall of the most hazardous opioid formulations is a powerful regulatory tool that should be deployed to address one aspect of the crisis: the excessive prescribing of opioids for chronic pain."

Juurlink and Herder point to Vanessa's Law, which empowers the Canadian Minister of Health to recall drugs from the marketplace when they pose “a serious or imminent risk of injury to health.”

Vanessa's Law was introduced into Parliament in 2014 by Trevor Young, a government member, when his 15-year-old daughter tragically died from heart failure after taking a stomach drug called Prepulsid (Cisapride). That same year, Health Canada removed the drug, as did the EU and the UK. It is only available in the U.S. under special conditions.

Health Canada has always had the power to pull drugs off the market and issue safety alerts. As for Vanessa’s Law, Health Canada told me it “has not encountered a situation where it has been necessary to use its authority to order a mandatory recall.”

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Obviously, there have been no valid safety reasons to limit high dose opioid prescriptions or it would have been done by now.

The CMAJ editorial claims that high dose opioids are potentially dangerous and that they increase the risk of accidental overdose, falls, fractures, cognitive impairment, worsening pain, motor vehicle accidents, and dependence. Of the five academic papers cited as evidence, four are authored by Juurlink himself or his research colleague at the Institute for Clinical and Evaluative Studies in Toronto. One of their papers was reported by this author in PNN as being erroneous and in need of correction. It was corrected, but it should have been retracted.

When the FDA sought public input into PROP’s petition, it received opposition from hundreds of patients and such groups as the American Academy of Pain Medicine (AAPM), the American Medical Association, the American Society of Anesthesiologists, and the American Pain Society. The AAPM said several of the petition’s underlying premises “are either false, misleading or speculative.”

“Perhaps the most serious problem with the petition is its cavalier assumption that in those patients in whom high doses are required, the change would be ‘unlikely to result in a significant inconvenience or hardship.’ Nothing could be farther from the truth. It is undisputed that many end-of-life patients require and benefit from opioid doses that are often quite high,” the AAPM said.

Other critics pointed out that taking high dose pills off the market would result in more lower dose pills being prescribed and stored in medicine cabinets, where they could potentially be stolen or diverted. It also raises the risk of a patient taking too many or too few low dose pills to get pain relief.

Dr. Juurlink has previously claimed that the long-term use of opioids results in an increase in pain called opioid induced hyperalgesia (OIH). He wrote about hyperalgesia in an earlier article in CMAJ, saying pain patients may think opioids are helping them, when they’re not.

“Why might some of these patients not be doing as well as they or their doctors perceive?” Dr. Juurlink asked.

Well, the answer is that Dr. Juurlink knows better. He knows better than the patient and he knows better than their doctor. He knows that they are not doing well. What can anyone say to that level of arrogance?

I did write a reply to his arguments in CMAJ and pointed out that his concept of hyperalgesia is simply a theoretical construct with no solid evidence in the research literature.

It is truly unfortunate and criminal that the response from some “experts” and politicians to the rising deaths we are seeing from overdoses is directed at pain doctors and their patients, when there is little evidence they are the main cause of the opioid problem.

As I pointed out in my last PNN article, the Minister of Health continues to blame the wrong people and is incapable of providing any evidence for her position. The coroner in British Columbia has already put out data on the source of opioids involved in overdose deaths. Fentanyl was involved in 3 out of 4 deaths and its source was illegal, not prescribed.

A very recent investigation by Global News Network in Canada found that the smuggling of illicit fentanyl into Canada via BC is the responsibility of a Chinese gang called the Big Circle Boys. The billions of dollars of profits they make is laundered through casinos in that province and to buy property in Vancouver. The police are aware but simply do not have the resources to counter any of this.

Instead, officials go after doctors and patients. One pain patient I am in contact with just e-mailed me that his doctor continues to reduce his opioids to the point that he is ready to leave this world.

“I can’t understand the thought process of my pain doctor who continues to taper away at my meds,” he wrote.

And neither can I.

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Marvin Ross is a medical writer and publisher in Dundas, Ontario. He has been writing on chronic pain for the past year and is a regular contributor to the Huffington Post.

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

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

GOP Report Blames Medicaid for Opioid Crisis

By Pat Anson, Editor

A new congressional report claims there is “overwhelming evidence” that Medicaid has  contributed to the nation’s opioid crisis by making it easy for beneficiaries to obtain and abuse opioid prescriptions.

The lengthy report, called “Drugs for Dollars: How Medicaid Helps Fuel the Opioid Epidemic,” was prepared by the Republican controlled Senate Homeland Security and Governmental Affairs Committee. Democrats on the committee complained the report was concocted to discredit and demonize Medicaid expansion under the Affordable Care Act, also known as Obamacare.

The report cites 1,072 people since 2010 that have been convicted or accused of using Medicaid to improperly obtain prescription opioids.  That is only a tiny fraction of the nearly 70 million people enrolled in Medicaid, but the report nevertheless draws some sweeping conclusions.

“Overwhelming evidence shows that Medicaid has inadvertently contributed to the national tragedy that is the opioid epidemic, and has taken a toll that is playing out in courtrooms across the nation,” the committee staff reported.

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“Other well-intended government programs, such as Medicare, may provide similar incentives for rational actors to engage in bad behavior with highly addictive opioids. These issues hold major ramifications for public policy, along with the nation’s health. They deserve serious consideration and a sober national debate, one we hope this staff report will help to initiate. The victims of this terrible epidemic deserve no less.”

The report cites dozens of examples of doctors and beneficiaries abusing the system, such as a $1 billion scheme to defraud Medicaid and Medicare that involved numerous health care providers.

Committee staff also claimed that drug overdose deaths were rising nearly twice as fast in Medicaid expansion states as in non-expansion states. About 12 million more Americans receive Medicaid coverage under Obamacare.

“While there is clearly no single cause to the epidemic, evidence has emerged that Medicaid is playing a perverse and unintended role in helping to fuel and fund the opioid epidemic,” Sen. Ron Johnson (R-WI) wrote in a letter to Eric Hargan, the Acting Secretary of the Department of Health and Human Services.

“The data uncovered in this examination point to a larger systematic problem – because opioids are easily obtained and inexpensive through Medicaid, the structure of the program itself creates a series of incentives for beneficiaries to use opioids and sell them for potentially enormous profits.”

‘Total Hogwash’

The committee’s ranking Democrat, Sen. Claire McKaskill of Missouri, called the report misleading.

"This idea that Medicaid expansion is fueling the rise in opioid deaths is total hogwash," McCaskill said in a statement. "It is not supported by the facts. And I am concerned that this committee is using taxpayer dollars to push out this misinformation to advance a political agenda."

“Separate scientific studies conducted by other authors show that (the) opioid epidemic predates Medicaid expansion and that recent increases in overdoses stem from fentanyl and heroin, not prescriptions obtained through Medicaid.  Unlike the report released by the majority staff today, these studies were both scientific and comprehensive.”

The report’s conclusions were also questioned by a longtime critic of opioid prescribing.

“I believe the access to prescribers that Medicaid, Medicare and commercial insurance offers does increase the likelihood that someone might develop a disease often caused by prescriptions,” said Andrew Kolodny, MD, founder and Executive director of Physicians for Responsible Opioid Prescribing (PROP).

“But I do not believe that Medicaid should be singled out in this regard. Opioid overdoses have been increasing in people with all types of insurance and in people from all economic groups, from rich to poor.”

A report released this week by the Kaiser Family Foundation found that states with above average overdose death rates includes 18 states that expanded their Medicaid coverage and 8 states that did not.  Overall, Medicaid covers nearly 40% of the two million Americans estimated to have opioid addiction.

Patient Advocates Call on Brandeis to Fire Kolodny

By Pat Anson, Editor

A coalition of physicians, patient advocates and pain sufferers has written an open letter to Brandeis University asking for the dismissal of Andrew Kolodny, MD, a longtime critic of opioid prescribing who is co-director of opioid policy research at the university’s Heller School for Social Policy and Management.

Kolodny is the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group that has lobbied politicians and regulators for years to enact stronger measures to limit prescribing of opioid pain medication.

“Dr. Kolodny has been prominent in a national campaign to deny chronic pain patients even minimal management of their pain.  His actions are directed toward forcing draconian restrictions or outright withdrawal of this class of medications from medical practice,” reads the letter to Brandeis President Ronald Liebowitz and other top administrators at the university.

“He calls for forced tapering of patients formerly prescribed opioids. Policy positions for which he advocates are leading to the deaths of hundreds of chronic pain patients by suicide or pain-related heart failure and medical collapse.”

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The letter was drafted by Richard Lawhern, PhD, and signed by over 60 healthcare professionals and patient advocates, including pain management specialists Forest Tennant, MD, and Aimee Chagnon, MD. Lawhern is the corresponding secretary of the “Opioid Policy Correspondents List,” an ad hoc volunteer group that advocates for better pain care. The group receives no funding from outside sources.

To read the letter in its entirety, click here.

Kolodny is a controversial figure in the pain community and is often quoted in the news media as an expert on issues involving pain management, even though his professional background is in psychiatry and addiction treatment.  He often refers to opioid medication as “heroin pills” and has suggested that patients shouldn’t trust doctors who prescribe opioids.

“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,” Kolodny said on C-SPAN in 2015. “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.”

“Although Dr. Kolodny has a work history in public health and addiction psychiatry, he is neither qualified nor Board Certified in pain management -- a closely related field that has been profoundly and negatively impacted by his assertions concerning public policy. From his published articles and interviews, it is clear to many readers that he knows or cares little about chronic pain patients and their treatment,” Lawhern’s letter states.

In a series of Tweets earlier this year, Kolodny said patients on “dangerously high doses” of opioids should be tapered to lower doses even if they refuse. He then asked for specific examples of doctors “forcing tapers in a risky fashion.”

Dozens of people responded with examples of patients becoming seriously ill or committing suicide after forced tapering, which Kolodny ignored.   

The letter to Brandeis calls Kolodny "one of the most polarizing and hated figures in medicine" among people in pain.

“In our view and those of many people whom he has harmed, Dr. Kolodny makes no positive contribution to the work or reputation of Brandeis or its research centers.  To the contrary, we believe it is ethically and morally imperative that he be dismissed immediately from the University, before his presence further damages both your reputation and your financial endowments,” the letter states.

The university did not respond to a request for comment on the letter. Neither did Kolodny.

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Brandeis is a well-regarded liberal arts and private research university located near Boston. The Heller School for Social Policy and Management is often ranked as one of the top ten schools in social policy.  Kolodny joined Heller last year as a senior scientist after resigning as chief medical officer at Phoenix House, which runs a chain of addiction treatment centers.

Kolodny and PROP played central roles in developing the 2016 CDC opioid guidelines, which discourage primary care physicians from prescribing opioids for chronic pain. Although voluntary and only intended for primary care doctors, the guidelines have been widely adopted as mandatory by insurers, federal agencies and throughout the U.S. healthcare system.

In an online survey of over 3,100 pain patients and healthcare providers on the first anniversary of the guidelines’ release, most said the guidelines were harmful to patients, had not improved the quality of pain care, and failed to reduce opioid abuse and overdoses. Critics also cite anecdotal evidence that the guidelines have contributed to an increase in patient suicides.

Restricting Opioid Doses Won’t Help the Overdose Crisis

By Roger Chriss, Columnist

As the overdose crisis worsens, new strategies and policies are being considered, including a recent petition to remove so-called high-dose opioids from the market.

The petition asks the FDA to ban opioid pills that, when taken as directed, would add up to a daily dose equivalent to more than 90mg of morphine. It is signed by leaders of several anti-opioid activist groups, including Physicians for Responsible Opioid Prescribing (PROP).

"The existence of these products implies that they're safe. They're not,” says Andrew Kolodny, MD, Executive Director and founder of PROP. "These are not medicines. These are lethal weapons that should be removed from the market.”

Before we start removing access to pain medication, it’s incumbent upon us to analyze the question of prescription opioid doses and what role, if any, they have in the overdose crisis.

First, higher doses of opioids are more dangerous. That is obvious, since most substances become dangerous at a sufficiently high dose, or as the Swiss physician Paracelsus supposedly said, “The dose makes the poison.” It is reasonable to conclude that higher doses of an opioid would be riskier.

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But there is no inherent implication about safety in the existence of any substance. There is nothing "safe" about chemotherapy drugs, anti-seizure medication or anti-anxiety drugs, just as there is nothing safe about tobacco or alcohol.

Moreover, the opposite of safe is not necessarily dangerous, since something that is "dangerous" can still be clinically beneficial. Open heart surgery is dangerous, but beneficial to someone dying from heart disease.

Conspicuously absent from the signatories of the PROP petition are any physician groups or doctors involved in pain management. Asked to comment on the petition, the President of the Society of Palliative Care Pharmacists told Pharmacy Times that while she agreed that opioid abuse is an urgent concern, she dose not believe that removing high-dose opioids from the market would be the best way to combat the overdose crisis.

“Let’s put our efforts together in an interdisciplinary approach and train providers to accurately assess their patients rather than pulling certain drugs from the market, because there may be cancer patients or others who are truly benefiting from these high-dose opioids,” said Rabia Atayee, PharmD.

The petition argues that people who currently take high-dose opioid medication can simply take two or more lower-dose pills. This would supposedly reduce the risk of overdose when high-dose pills are stolen or diverted.

“Removing UHDU (ultra-high dosage unit) orally-administered opioids from the market will result in patients having to swallow more tablets or capsules. But this is unlikely to result in a significant inconvenience or hardship for patients,” the petition states.

In other words, there would be a trade off. The risk of an overdose would be lower for a person who gets an opioid analgesic from a friend to deal with severe pain. But a person with a disorder like achalasia that impairs swallowing or a GI disorder that impairs absorption may be harmed by having to take more pills.

Unintended Consequences

The strength of the arguments is only one factor here. The unintended consequences of this petition should also be considered. One obvious effect would be an increase in the total number of pills, which would exacerbate concerns about over-prescribing. There would be more pills to steal or divert, and more potential problems in securing the opioid supply chain from manufacturer to pharmacy, a major source of diverted pills that often goes unremarked and unpunished.

Another likely effect is increased activity on the black market. In 2010, when Purdue Pharma brought out its abuse deterring form of OxyContin, some abusers started switching to illegal drugs, including heroin. An uncomfortable outcome of this well-intentioned change is that a public health policy meant to prevent abuse and addiction may have made the overdose crisis worse.

A similar outcome could result from this petition: Drug abusers who are intent on having a high-dose opioid pill may shift to street drugs.

Another possible outcome is that opioid doses keep getting smaller and smaller. If a daily dose of pills containing 90mg of a morphine equivalent (MME) is considered “dangerous,” then what about 80 MME? Or 70 MME? If the changes recommended in this petition do not work, will we try more restrictions in doses and prescribing? Clear measures of the success or failure of the proposal should be defined in a petition like this one, but they are not.

We already have vast quantities of data about the opioid crisis. According to the CDC, opioid prescribing peaked in 2010 and has been in decline ever since, yet overdose rates keep rising. 

The average daily dose of opioids started falling even earlier, in 2006. By 2015, it had declined to nearly 48 MME -- well below the dose sought in the petition.

AVERAGE DAILY PER CAPITA MORPHINE EQUIVALENT DOSE (MME)

Source: CDC/QuintilesIMS

In other words, reducing the amount and dose of prescription opioids is inversely correlated with the number of overdoses. Of course, correlation is not causation, but the negative correlation does not bode well for the effects of this petition. Based on this data, the best we can reasonably hope for is small benefits on the margins of the overdose crisis, at the expense of people who benefit from high-dose prescription opioids.

And this petition will do nothing to improve treatment for people suffering from opioid use disorder or to reduce the risks of people overdosing on heroin or illicit fentanyl. These are key features of the opioid crisis, and a policy that claims to beat addiction without addressing them should be greeted with skepticism.

Instead of new restrictions, perhaps the CDC and state guidelines can be updated to include recommendations that physicians and pharmacists discuss with patients the safe storage and disposal of opioid medications.

Before we ban a medication for having too much of a chemically active ingredient for people who abuse it, we should do whatever we can to ensure that the people who benefit from it are not harmed.

To make a comment on the PROP petition to the FDA, click here.

Roger Chriss.jpg

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

Petition Calls on FDA to Ban High Dose Opioids

By Pat Anson, Editor

A group of anti-opioid activists has filed a citizen petition with the Food and Drug Administration, asking the agency to remove most high dose opioid pain medications from the market.

The petition would apply to all opioid pills that exceed a daily dose of 90mg morphine equivalent units (MMEs), which the Centers for Disease Control and Prevention set last year as the highest recommended dose for primary care physicians and their patients.  

Such a ceiling, if adopted by the FDA, would take all OxyContin 80mg tablets off the market, as well as many other high-dose oral painkillers. A single OxyContin 80mg tablet, according to the petition, is equivalent to 160 MME.

Another example cited in the petition would be immediate release oxycodone 30mg tablets. If four such pills are taken daily, as they are often prescribed, that adds up to 180 MME.

The petition claims high dose opioid pills raise the risk of overdose and addiction, and are especially harmful to children.

OxyContin.jpg

“These products are just too dangerous, there's no need for them," said Pete Jackson, who lost his teenage daughter to an OxyContin overdose.

"These are not medicines. These are lethal weapons that should be removed from the market," said Andrew Kolodny, MD, an addiction treatment specialist and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), one of five anti-opioid activists who signed the petition. None are considered experts in pain management.

“Removing UHDU (ultra-high dosage unit) orally-administered opioids from the market will result in patients having to swallow more tablets or capsules. But this is unlikely to result in a significant inconvenience or hardship for patients,” the petition states. “For patients that may have difficulty swallowing it is important to note that opioid analgesics are available in liquid preparations, sublingual preparations, patches and suppositories.”

Opioids ‘Can Be Appropriate’

In a rare acknowledgement that opioids "can be appropriate" for some pain patients, Kolodny and the other petitioners wrote that "the benefits of prescribing high doses may outweigh the risks when treating severe pain from a life-limiting illness."

But then they make the dubious claim that flooding the market with lower-dose pills will somehow be safer. Reducing the potency of painkillers would mean patients need more to get pain relief – resulting in more pills being prescribed, stored in medicine cabinets, and possibly stolen or diverted – hardly a prescription for reducing abuse.

Having to take more pills could also be risky to patients.  

"With a very large number of pills to manage, they are going to be at more risk of taking the wrong number of pills and of having some of those pills swiped by others without them noticing," Stefan Kertesz, MD, an Alabama primary care physician, told the Associated Press.

“Given the significance of the nation’s opioid crisis, this petition and issue should be discussed by the scientific experts at FDA and we look forward to participating in such a discussion,” Purdue Pharma, the maker of OxyContin, said in a statement. “It is critical that we seek the appropriate balance of treating pain severe enough that requires opioid treatment for which alternative treatments are inadequate, with efforts combating the opioid crisis.”

The FDA had no immediate comment on the petition.  Any U.S. citizen can file a petition with the agency to seek the removal of a drug or medical device for safety issues.

In June, the FDA asked Endo Pharmaceuticals to take Opana ER off the market because it was being abused, the first time that sales of an opioid painkiller have been halted. FDA commissioner Scott Gottlieb, MD, has hinted the agency could take other painkillers off the market.

“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse,” Gottlieb said in June.

To make a comment on the PROP petition to the FDA, click here.

An Inconvenient Footnote in the Opioid Crisis

By Roger Chriss, Columnist

The opioid crisis is now a national emergency. President Trump has instructed his administration “to use all appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic.”

The full strategy is not entirely clear. But so far, prevention, strict regulation and law enforcement are its core features. The Department of Justice recently announced the formation of its new Opioid Fraud and Abuse Detection Unit. The DEA has proposed a further reduction in opioid production quotas. And the FDA is working to reduce the flow of illicit fentanyl in the postal service.

Meanwhile, anti-opioid activist groups such as the Physicians for Responsible Opioid Prescribing (PROP) are pushing for stricter prescribing regulations and reduced prescribing levels.

As PROP stated in a letter to FDA Commissioner Scott Gottlieb, “Until opioids are prescribed more cautiously it will not be possible to bring the opioid addiction epidemic under control.”

Amid all this, people with persistent pain disorders are little more than an inconvenient footnote.

The evidence clearly shows that the opioid crisis is being driven primarily by illegal drugs. Time magazine reports that in a large national survey, 60% of those who reported misusing opioid medication did so without a prescription. “About 40% of these people accessed opioids free from friends or relatives. Among people who developed addiction or other abuse disorders, 14% said they bought them from drug dealers or strangers," Time said.

Moreover, people who are addicted to heroin rarely get their start with opioids prescribed for a valid medical condition. A study in JAMA Psychiatry found that heroin addicts often have a history of abusing opioid medication because “prescription opioids are much more readily available to younger individuals, particularly as an initial drug of abuse, given the common belief that because prescription opioids are legal, they are considered trustworthy and predictable."

Few media reports mention the strict conditions under which opioids are prescribed in pain contracts between doctors and patients. As described in Pain Medicine News, a “Stipulations of Opioid Treatment Agreement” requires that patients on opioid therapy use only one pharmacy, undergo random urine drug screening, and abstain from alcohol.

Yet all of this goes largely ignored. The narrative of the opioid crisis has been streamlined and simplified to the point that chronic pain patients are either part of the problem, or at least getting in the way of the solution. The CDC guidelines and PROP, as well as state laws and regulations, treat pain patients as an afterthought. We are an inconvenient footnote.

But persistent pain cannot be ignored. Its physical and emotional impact is so costly, that a group of economists recently put a price tag on it.  They estimate that avoiding a single day of chronic pain is worth up $145 for the average person. That works out to nearly $53,000 per year.

This means pain management is extremely valuable to most people.
The pain of connective tissue disorders like Ehlers-Danlos syndrome and other incurable chronic pain conditions like adhesive arachnoiditis can be crippling. People living with these disorders need to have all options on the table because the worst has already happened and they are trying to survive as best as they can.

The Washington state opioid prescribing guideline states that "in carefully selected and monitored patients, opioids may provide effective pain relief if used as part of a comprehensive multimodal pain management strategy. A combination of pharmacologic, non-pharmacologic, and rehabilitative approaches in addition to a strong therapeutic alliance between the older patient and physician is essential to achieve desired treatment outcomes."

That excerpt is from the chapter on “Chronic Pain Management in Special Populations,” a group that arguably should include people with chronic, progressive, or degenerative disorders.

A similar statement from the CDC or even PROP that long-term opioid therapy can be useful for some patients when other pain treatments are ineffective would help keep all pain management options on the table.

We have a chance to stop the worsening crisis of pain mismanagement that is resulting from well-intentioned efforts to address the opioid crisis. A few words added to the CDC guideline or the position statements of groups like PROP could help chronic pain sufferers avoid the perils of being an inconvenient footnote.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

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

PROP Founder Calls for Forced Opioid Tapering

By Pat Anson, Editor

Have you or a loved one been harmed by being tapered off high doses of opioid pain medication?

The founder of an anti-opioid activist group wants to know – or at least he posed the question during a debate about opioid tapering with colleagues on Twitter this week.

“Outside of palliative care, dangerously high doses should be reduced even if patient refuses.  Where exactly is this done in a risky way?” wrote Andrew Kolodny, MD, Executive Director of Physicians for Responsible Opioid Prescribing (PROP). 

“I’m asking you to point to a specific clinic or health system that is forcing tapers in a risky fashion. Where is this happening?”

It’s not an idle question. About 10 million Americans take opioid medication daily for chronic pain, and many are being weaned or tapered to lower doses -- some willingly, some not -- because of fears that high doses can lead to addiction and overdose.

Kolodny’s Twitter posts were triggered by recent research published in the Annals of Internal Medicine that evaluated 67 studies on the safety and effectiveness of opioid tapering. Most of those studies were considered very poor quality.

“Although confidence is limited by the very low quality of evidence overall, findings from this systematic review suggest that pain, function, and quality of life may improve during and after opioid dose reduction,” wrote co-author Erin Krebs, MD, of the Minneapolis Veterans Affairs Health Care System. 

Krebs was an original member of the “Core Expert Group” – an advisory panel that secretly helped draft the CDC opioid prescribing guidelines with a good deal of input from PROP. She also appeared in a lecture series on opioid prescribing that was funded by the Steve Rummler Hope Foundation, which coincidentally is the fiscal sponsor of PROP. 

Curiously, while Krebs and her colleagues were willing to accept poor quality evidence about the benefits of tapering, they were not as eager to accept poor evidence of the risks associated with tapering. 

“This review found insufficient evidence on adverse events related to opioid tapering, such as accidental overdose if patients resume use of high-dose opioids or switch to illicit opioid sources or onset of suicidality or other mental health symptoms,” wrote Krebs.

But the risk of suicide is not be taken lightly, as we learned in the case of Bryan Spece, a 54-year old chronic pain sufferer who shot himself to death a few weeks after his high oxycodone dose was abruptly reduced by 70 percent.  Hundreds of other pain sufferers at the Montana clinic where Spece was a patient have also seen their doses cut or stopped entirely.

Spece’s suicide was not an isolated incident, as we are often reminded by PNN readers.

“A 38 year old young lady here took a gun and put a bullet in her head after being abruptly cut off of her pain medication,” Helen wrote to us. “Her whole life ahead of her. This is happening every day, it just isn't being reported.”

“I too recently lost a friend who took his own life due to the fact that he was in constant pain and the clinic he was going to cut him off completely,” said Tony.

“I have been made to detox on my own as doctors who were not comfortable giving out these meds would take me off, not wean me,” wrote Brian. “Was a nightmare. Thought I was gonna die. No, I wanted to die.”

“In the end when you realize that you’re not going to get help and that you have nothing left, suicide is all you have,” wrote Justin, who is disabled by pain and no longer able to work or pay his bills after being taken off opioids. “I don't want to hurt my family. I don't want to die. However it is the only way out now. I just hope my family and the good Lord can forgive me.”

Patient advocates like Terri Lewis, PhD, say it is reckless to abruptly taper anyone off high doses of opioids or to aim for artificial goals such as a particular dose. She says every patient is different.

“There is plenty of evidence that persons treated with opiates have variable responses - some achieve no benefit at all.  Some require very little, others require larger doses to achieve the same benefit,” Lewis wrote in an email to PNN.

“It is an over-generalization to claim that opiates are lousy drugs for chronic pain. Chronic pain is generated from more than 200 medical conditions, each of which generate differing patterns of illness and pain generation. For some, it may be reflective of its own unique disease process. We have to retain the ability to treat the person, not the label, not to the dose.”

Patient ‘Buy-in’ Important for Successful Tapering

And what about Kolodny’s contention that high opioid doses should be reduced even if a patient refuses? Not a good idea, according to a top CDC official, who says patient “buy-in” and collaboration is important if tapering is to be successful.

“Neither (Kreb’s) review nor CDC's guideline provides support for involuntary or precipitous tapering. Such practice could be associated with withdrawal symptoms, damage to the clinician–patient relationship, and patients obtaining opioids from other sources,” wrote Deborah Dowell, MD, a CDC Senior Medical Advisor, in an editorial in the Annals of Internal Medicine.  “Clinicians have a responsibility to carefully manage opioid therapy and not abandon patients in chronic pain. Obtaining patient buy-in before tapering is a critical and not insurmountable task.”

The CDC guideline also stresses that tapering should be done slowly and with patient input.

“For patients who agree to taper opioids to lower dosages, clinicians should collaborate with the patient on a tapering plan,” the guideline states. “Experts noted that patients tapering opioids after taking them for years might require very slow opioid tapers as well as pauses in the taper to allow gradual accommodation to lower opioid dosages.”

The CDC recommends a "go slow" approach and individualized treatment when patients are tapered.  A "reasonable starting point" would be 10% of the original dose per week, according to the CDC, and patients who have been on opioids for a long time should have even slower tapers of 10% a month.

The Department of Veterans Affairs takes a more aggressive approach to tapering, recommending tapers of 5% to 20% every four weeks, although in some high dose cases the VA says an initial rapid taper of 20% to 50% a day is needed. If a veteran resists tapering, VA doctors are advised to request mental health support and consider the possibility that the patient has an opioid use disorder.

Have you been tapered at a level faster than what the CDC and VA recommend? Let us know by leaving a comment below.

If you think you were tapered in a risky way, you can let Dr. Kolodny know at his Twitter address: @andrewkolodny.

PROP Urges Members to Oppose FDA Opioid Strategy

By Pat Anson, Editor

An anti-opioid activist group has sent an “Urgent Action Request” to it members, asking them to oppose plans by the Food and Drug Administration to give new guidance to health care providers about prescribing opioid pain medication.

The initial draft of the guideline for Prescriber Education for Extended-Release and Long-Acting Opioids Risk Evaluation and Mitigation Strategies – more simply known as REMS -- warns prescribers at length about the risk of overdose, addiction and the “epidemic of prescription opioid drug abuse.” But Physicians for Responsible Opioid Prescribing (PROP) doesn’t think the draft goes far enough.

“The current draft is seriously flawed,” wrote PROP founder and Executive Director Andrew Kolodny, MD, in an email to supporters urging them to leave a comment in the Federal Register before the public comment period on the REMS guideline ends on Monday, July 10.

“Please post a comment about the draft on the FDA federal docket. FDA is required to review the comments and tally them. If FDA receives enough critical comments, there is a good chance they'll improve the document.” 

Kolodny’s email provides a “sample comment” for PROP members to use, urging the FDA to adopt an upper dose limit on opioids, mention the “lack of evidence supporting long-term opioid use” and provide a list of pain conditions for which opioids are “inappropriate” – such as fibromyalgia and chronic headache.

Until now, the REMS draft guideline – an update to a similar guideline released in 2012 – has drawn little public attention. Less than 300 comments have been made in the Federal Register, most of them focused on whether acupuncture and chiropractic care should be included as alternative treatments to opioids. 

The 10-page guideline warns doctors repeatedly about using caution when prescribing opioids, but it stops short of setting an artificial ceiling on doses, such as those recommended last year by the Centers for Disease Control and Prevention and an even tougher guideline recently adopted by the Departments of Veterans Affairs and Defense (VA/DOD).

“We believe the REMS curriculum should be based on the CDC guideline and the VA/DOD guideline,” wrote Kolodny and other PROP board members in a letter to FDA commissioner Scott Gottlieb, MD. “The CDC and VA/DOD guideline warn against prescribing high doses of opioids and specifically recommend against doses greater than 90mg morphine equivalents. The Blueprint omits this critical topic.”

“I don't agree that the new blueprint is inconsistent with recommendations from other government agencies. For one thing, there is a specific statement in the blueprint that HCPs (health care providers) should know about the CDC guideline and other guidelines regarding safe opioid prescribing,” said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management, an organization of pain management providers.

“Let me also point out that PROP's call for inclusion of ‘an upper dose limit consistent with recommendations from other federal agencies’ perpetuates the myth that the CDC guideline contains such an upper dose limit. CDC was very clear when it issued the guideline that it should be considered to contain recommendations, not limits.”

The REMS guideline not only does not endorse a specific limit on opioids, it recommends that “a comprehensive treatment plan should be developed and customized to the needs of the individual patient.”  The focus on individualized patient care is something else that PROP takes issue with.

“Since the purpose of the Blueprint is to teach more cautious prescribing the focus should be first and foremost on when to use opioids for acute and chronic pain, and secondly, on how to use opioids as safely as possible. The Blueprint does not need to teach how to make a pain diagnosis, or what alternatives there are to opioids, both of which should be considered beyond the scope of REMS,” wrote Kolodny his his letter. “Until opioids are prescribed more cautiously it will not be possible to bring the opioid addiction epidemic under control.”

But opioids are being prescribed more cautiously and have been since 2010, as we learned from a new CDC study. Yet the nation’s opioid crisis continues to worsen, fueled by heroin, illicit fentanyl, counterfeit painkillers, and failed strategies to control the crisis by denying many pain patients their only form of treatment.   

To see the FDA’s draft REMS guideline, click here. To leave your own comment on the Federal Register, click here.