Kolodny Clarifies His Conflicts of Interest

By Pat Anson, PNN Editor

Dr. Andrew Kolodny has revised his conflict of interest statements for two articles he co-authored in the Journal of the American Medical Association (JAMA) to include his work in malpractice lawsuits involving opioid medication.

Kolodny, the founder and Executive Director of Physicians for Responsible Opioid Prescribing (PROP), is a longtime critic of opioid prescribing. He recently testified as the “star witness” for Oklahoma in its opioid negligence lawsuit against Johnson & Johnson, a case the state won with a $572 million judgement against J&J.

“I am writing to provide additional information to clarify conflict of interest disclosures in 2 articles I published in JAMA in 2017 and 2018.  During this time, I received compensation for work as an expert in malpractice litigation involving opioid prescribing,” Kolodny wrote in a Sept. 4 letter to JAMA’s editors.

“When the articles were first published, I did not believe this work could be perceived as a potential conflict of interest. My view has since changed. In the spirit of full transparency, I am requesting a correction to my disclosure statements.”

The two JAMA articles in question, which were co-authored by former CDC director Thomas Frieden, MD, both dealt with the opioid crisis and the federal policy response to it.

JAMA disclosure policy is very clear and requires authors to list “all relevant financial interests, activities, relationships and affiliations,” including payments for employment, consultancies and expert testimony.

During the Oklahoma trial, Kolodny admitted under questioning by J&J lawyers that he was being paid $725 an hour by Nix Patterson & Roach, one of three law firms hired by Oklahoma to handle the case against J&J. Kolodny anticipated being paid up to $500,000 by the end the Oklahoma trial.

“I don’t think it should be a secret that I’m being compensated,” he said.  

Kolodny also acknowledged working for the law firm of Cohen Milstein Sellers & Toll in a similar capacity, also for $725 an hour. Cohen Milstein is heavily involved in opioid litigation in New Jersey, Indiana, Vermont, California and Illinois. 

Kolodny’s work in opioid litigation was disclosed in the April 2018 JAMA article.

DR. ANDREW KOLODNY

DR. ANDREW KOLODNY

His revised disclosure statement for that article is vague, stating that he worked as “a medical expert for states and counties that have filed suits against opioid manufacturers and as an expert witness in malpractice cases involving opioid prescribing.” It does not identify which states, counties and law firms he worked for or what companies were being sued. 

JAMA policy calls for “complete disclosure of all potential conflicts of interest” covering a three-year period prior to an article being submitted. If an author received funding from the pharmaceutical industry, for example, he or she would be expected to identify the company involved.   

“It is encouraging that Dr. Kolodny has recognized that his very profitable work supporting plaintiffs in opioid lawsuits might constitute a conflict of interest when he writes about opioid policy and clinical practice,” said Bob Twillman, PhD, a healthcare policy consultant and former Executive Director of the Academy of Pain Management. “Of course, these aren't the only two articles Dr. Kolodny has co-authored, and he has done numerous presentations at professional meetings as well, so I wonder if he will seek to correct all the rest of those relevant disclosure statements.

“I think it's also interesting that, when I disclose my conflict, I am always required to specifically name the entity involved, yet Dr. Kolodny names neither the jurisdictions nor the law firms for which he was working. It seems a little like a double standard to me, and I wonder how the editorial boards of the relevant journals feel about that.”

In March 2017, Kolodny co-authored a research letter in JAMA Internal Medicine on a study he designed that looked into funding that patient advocacy groups and professional organizations received from opioid manufacturers. Many of those organizations publicly opposed the CDC’s controversial opioid prescribing guideline, which Kolodny and other PROP members helped draft.

“The CDC did not prompt or require organizations to disclose their financial associations as part of their comments. Disclosure, however, is one means of managing conflicts of interest,” Kolodny and his co-authors wrote. “Our findings demonstrate that greater transparency is required about the financial relationships between opioid manufacturers and patient and professional groups.”

Kolodny’s disclosure statement for the 2017 article states that he was a member of PROP and Chief Medical Officer for the addiction treatment chain Phoenix House (which he has since left). It makes no mention of his work in opioid litigation or malpractice lawsuits, which may have begun at a later date.

Lucrative Sideline

Kolodny is not the only critic of opioid prescribing to develop a lucrative sideline as a medical expert or paid witness. Dr. Adriane Fugh-Berman, Director of PharmedOUT, a program at Georgetown University that seeks to expose deceptive healthcare marketing practices, has also been paid handsomely for her testimony.

In August, Fugh-Berman testified in California that she was paid $500 an hour for her work in a pelvic mesh liability trial of Johnson & Johnson. She received about $120,000 for her work on the case, according to Northern California Record.

Fugh-Berman has written several op/eds claiming that “industry-funded attacks” on the CDC guideline by physician and patient advocacy groups were part of a “coordinated attempt by opioid manufacturers to use third parties to undermine, discredit, and smear the guideline.”

Fugh-Berman discloses on PharmedOUT’s website that she is a paid expert witness, but she won’t say who funds her organization.

“(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 in an email to PNN.  

Dr. Timothy Munzing, a Kaiser Permanente family practice physician in California, has also stoutly defended the CDC guideline and warned against excessive opioid prescribing.

“Most prescribing physicians feeding the opioid epidemic are well meaning, naïve, or just too busy to recognize the dangers,” he wrote in a physician guide for opioid prescribing published by Kaiser Permanente.

Over the past decade, Munzing has established a profitable career as an expert witness for the Medical Board of California, DEA, FBI and DOJ, working mostly on cases that involve doctors flagged for overprescribing opioids.

According to GovTribe.com, which tracks payments to federal contractors, Munzing has been awarded nearly $1.3 million in DOJ contracts since 2017 and is currently working on over two dozen DEA investigations.

After he left Phoenix House, Kolodny became the co-director of an opioid research program at Brandeis University that is funded with over $8.5 million federal grants, according to GovTribe.com.

Oklahoma Judge Orders J&J to Pay $572 Million in Damages

By Pat Anson, PNN Editor

In a precedent setting case, an Oklahoma judge has ruled that Johnson & Johnson is partly responsible for fueling Oklahoma’s opioid crisis and ordered the health care giant to pay $572 million in damages.

“The opioid crisis has ravaged the state of Oklahoma and must be abated immediately,” said Cleveland County District Judge Thad Balkman, reading his decision aloud from the bench.

Balkman said J&J concocted a ‘marketing scheme” for opioid pain medication that overstated the drugs’ effectiveness and underplayed their risks. The company’s subsidiary, Janssen Pharmaceutical, produced less than one percent of the opioids prescribed in Oklahoma, but supplied 60% of the ingredients in painkillers sold by other companies.  

“They developed and carried out a plan to directly influence and convince doctors to prescribe more and more opioids, despite the fact that defendants knew increasing the supply of opioids would lead to abuse, addiction, misuse, death and crime,” the judge said.

Oklahoma had asked for $17.5 billion from J&J to pay for addiction treatment, emergency care, law enforcement and other services needed to address the opioid crisis. J&J said it would appeal the judges “flawed” ruling.

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"Janssen did not cause the opioid crisis in Oklahoma, and neither the facts nor the law support this outcome," Michael Ullmann, Executive Vice President and General Counsel for J&J, said in a statement. “This judgment is a misapplication of public nuisance law that has already been rejected by judges in other states.

"The unprecedented award for the State's 'abatement plan' has sweeping ramifications for many industries and bears no relation to the Company's medicines or conduct." 

Balkman’s ruling is not legally binding on any other court, but as the first opioid case to go to trial, it is expected to have a significant impact on negotiations to resolve nearly 2,000 lawsuits filed by states, cities and counties against opioid makers, distributors and pharmacies. Many of those cases have been consolidated before a federal judge in Ohio.

Oklahoma previously reached a $270 million out-of-court settlement with Oxycontin-maker Purdue Pharma and an $85 million deal with Teva Pharmaceutical. Endo International and Allergan recently agreed to pay $10 million and $5 million respectively to two Ohio counties to avoid going to trial.

Compared to the cost and bad publicity that J&J went through defending itself in Oklahoma, those settlements look prescient.

As PNN has reported, three law firms that acted as lead outside counsel for Oklahoma stand to collect 25% of the damages and penalties awarded to the state. Oklahoma’s star witness, anti-opioid activist Dr. Andrew Kolodny, testified that he was paid $500,000 for his services at a rate of $725 an hour.

Closing Arguments in Oklahoma Opioid Trial

By Jackie Fortier, StateImpact Oklahoma

A global megacorporation best known for Band-Aids and baby powder may have to pay billions for its alleged role in the opioid crisis. Johnson & Johnson was the sole defendant in a closely watched trial that wrapped up in Oklahoma state court this week, with a decision expected later this summer.

The ruling in the civil case could be the first that would hold a pharmaceutical company responsible for one of the worst drug epidemics in American history.

Oklahoma Attorney General Mike Hunter’s lawsuit alleges Johnson & Johnson and its subsidiary Janssen Pharmaceuticals helped ignite the opioid crisis with overly aggressive marketing, leading to thousands of overdose deaths over the past decade in Oklahoma alone.

The trial took place over seven weeks in the college town of Norman. Instead of a jury, a state judge heard the case. During closing arguments Monday, Hunter called the company the “kingpin” of the opioid crisis.

“What is truly unprecedented here is the conduct of these defendants on embarking on a cunning, cynical and deceitful scheme to create the need for opioids,” Hunter said.

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The state urged Judge Thad Balkman, who presided over the civil trial, to find Johnson & Johnson liable for creating a “public nuisance” and force the company to pay more than $17 billion over 30 years to abate the public health crisis in the state.

Driving the opioid crisis home has been a cornerstone of Oklahoma’s lawsuit. In closing arguments Monday, one of the state’s attorneys, Brad Beckworth, cited staggering prescribing statistics in the county where the trial took place.

“What we do have in Cleveland County is 135 prescription opioids for every adult,” Beckworth said. “Those didn’t get here from drug cartels. They got here from one cartel: the pharmaceutical industry cartel. And the kingpin of it all is Johnson & Johnson.”

Johnson & Johnson’s attorney Larry Ottaway, rejected that idea in his closing argument, saying the company’s products, which had included the fentanyl patch Duragesic and the opioid-based pill Nucynta, were minimally used in Oklahoma.

He scoffed at the idea that physicians in the state were convinced to unnecessarily prescribe opioids due to the company’s marketing tactics.

“The FDA label clearly set forth the risk of addiction, abuse and misuse that could lead to overdose and death. Don’t tell me that doctors weren’t aware of the risks,” Ottaway said.

Ottaway played video testimony from earlier in the trial, showing Oklahoma doctors who said they were not misled about the drugs’ risks before prescribing them.

“Only a company that believes its innocence would come in and defend itself against a state, but we take the challenge on because we believe we are right,” Ottaway argued.

Initially, Hunter’s lawsuit included Purdue Pharma, the maker of OxyContin. In March, Purdue Pharma settled with the state for $270 million. Soon after, Hunter dropped all but one of the civil claims, including fraud, against the two remaining defendants.

Just two days before the trial began, another defendant, Teva Pharmaceuticals of Jerusalem, announced an $85 million settlement with the state. The money will be used for litigation costs and an undisclosed amount will be allocated “to abate the opioid crisis in Oklahoma,” according to a press release from Hunter’s office.

Both companies deny any wrongdoing.

The Legal Liability of ‘Public Nuisance’

Most states and more than 1,600 local and tribal governments are suing drugmakers who manufactured various kinds of opioid medications, and drug distributors. They are trying to recoup billions of dollars spent addressing the human costs of opioid addiction.

“Everyone is looking to see what’s going to happen with this case, whether it is going to be tobacco all over again, or whether it’s going to go the way the litigation against the gun-makers went,” says University of Georgia law professor Elizabeth Burch.

But the legal strategy is complicated. Unlike the tobacco industry, from which states won a landmark settlement, the makers of prescription opioids manufacture a product that serves a legitimate medical purpose, and is prescribed by highly trained physicians — a point that Johnson & Johnson’s lawyers made numerous times during the trial.

Oklahoma’s legal team based its entire case on a claim of public nuisance, which refers to actions that harm members of the public, including injury to public health. Burch says each state has its own public nuisance statute, and Oklahoma’s is very broad.

“Johnson & Johnson, in some ways, is right to raise the question: If we’re going to apply public nuisance to us, under these circumstances, what are the limits?” Burch said. “If the judge or an appellate court sides with the state, they are going to have to write a very specific ruling on why public nuisance applies to this case.”

Burch said the challenge for Oklahoma has been to tie one opioid manufacturer to all of the harms caused by the ongoing public health crisis, which includes people struggling with addiction to prescription drugs, but also those harmed by illegal street opioids, such as heroin.

University of Kentucky law professor Richard Ausness agreed that it’s difficult to pin all the problems on just one company.

“Companies do unethical or immoral things all the time, but that doesn’t make it illegal,” Ausness said.

If the judge rules against Johnson & Johnson, Ausness said, it could compel other drug companies facing litigation to settle out of court. Conversely, a victory for the drug giant could embolden the industry in the other cases.

Oklahoma’s Paid Expert Witness

Earlier in the trial, the state’s paid expert witness, Dr. Andrew Kolodny, testified that Johnson & Johnson did more than push its own pills — until 2016, it also profited by manufacturing raw ingredients for opioids and then selling them to other companies, including Purdue, which makes Oxycontin.

“Purdue Pharma and the Sacklers have been stealing the spotlight, but Johnson & Johnson in some ways, has been even worse,” said Kolodny, who indicated he would be paid upwards of $500,000 for his testimony.

Kolodny said that’s why the company downplayed to doctors the risks of opioids as a general class of drugs, knowing that almost any opioid prescription would benefit its bottom line.

The state’s case also focused on the role of drug sales representatives. Drue Diesselhorst was one of Johnson & Johnson’s busiest drug reps in Oklahoma. Records discussed during the trial showed she continued to call on Oklahoma doctors who had been disciplined by the state for overprescribing opioids. She even continued to meet with doctors who had patients who died from overdoses.

DR. ANDREW KOLODNY

DR. ANDREW KOLODNY

But Diesselhorst testified she didn’t know about the deaths, and no one ever instructed her to stop targeting those high-prescribing physicians.

“My job was to be a sales rep. My job was not to figure out the red flags,” she said on the witness stand.

Johnson & Johnson’s Defense

Throughout the trial, Johnson & Johnson’s defense team avoided many of the broader accusations made by the state, instead focusing on the question of whether the specific opioids manufactured by the company could have caused Oklahoma’s high rates of addiction and deaths from overdose.

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Johnson & Johnson’s lawyer, Larry Ottaway, argued the company’s opioid products had a smaller market share in the state compared to other pharmaceutical companies, and he stressed that the company made every effort when the drugs were tested to prevent abuse.

He also pointed out that the sale of both the raw ingredients and prescription opioids themselves are heavily regulated.

“This is not a free market,” he said. “The supply is regulated by the government.”

Ottaway maintained the company was addressing the desperate medical need of people suffering from debilitating, chronic pain — using medicines regulated by the Food and Drug Administration and the Drug Enforcement Administration. Even Oklahoma purchases these drugs, for use in state health care services.

Judge Thad Balkman is expected to announce a verdict in August.

If the state’s claim prevails, Johnson & Johnson could, ultimately, have to spend billions of dollars in Oklahoma helping to ease the epidemic. State attorneys are asking that the company pay $17.5 billion over 30 years, to help abate the crisis in the state.

Balkman could choose to award the full amount, or just some portion of it, if he agrees with the state’s claim.

“You know, in some ways I think it’s the right strategy to go for the $17 billion,” Burch, the law professor, said. “[The state is saying] look, the statute doesn’t limit it for us, so we’re going to ask for everything we possibly can.”

In the case of a loss, Johnson & Johnson is widely expected to appeal the verdict. If Oklahoma loses, the state will appeal, Attorney General Mike Hunter said Monday.

This story is part of a partnership that includes StateImpact Oklahoma, NPR and Kaiser Health News. KHN is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Opioid Addiction Rates Redux

By Roger Chriss, PNN Columnist

The Oklahoma opioid trial is garnering attention for what could be a pivotal role in determining the liability of Johnson & Johnson and other drug makers in the opioid crisis. A key point hinges on a seemingly simple question: What percentage of people on long-term opioid therapy develop addiction?

Dr. Timothy Fong, a UCLA psychiatrist and defense expert, refuted claims by prosecution witness Dr. Andrew Kolodny that people who take opioid pain medication over extended periods have a 25% chance of becoming addicted. Fong said other studies suggest that patients who take opioids over long periods might have addiction rates closer to 1 to 3 percent.  

There is an extensive literature on these estimates, including NIH studies and published research from leading experts. I covered some of them in a PNN column last year (see “How Common Is Opioid Addiction?”)

“The best and most recent estimate of the percentage of patients who will develop an addiction after being prescribed an opioid analgesic for long-term management of their chronic pain stands at around 8 percent,” NIDA director Nora Volkow, MD, told Opioid Watch.

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Why are there so many different estimates? There is an important distinction between the incidence and prevalence of a medical condition. Briefly, incidence represents the probability of occurrence of a given medical condition in a population within a specified period of time. In contrast, prevalence gives the proportion of a particular population found to be affected by a medical condition.

The distinction is not just semantics and is critical in epidemiology. As explained in Physiopedia, “incidence conveys information about the risk of contracting the disease, whereas prevalence indicates how widespread the disease is.”

Besides obvious difficulties in determining incidence (the necessary clinical trials will never receive approval) and measuring prevalence (the required public health monitoring is well beyond our current capability), we instead have to rely on proxy measures derived from prescription drug databases, medical records and surveys.

We also have to make decisions about the “specified period of time” when determining incidence and the assessment of the “medical condition’ for prevalence.

There is no universally agreed upon time frame for the development of addiction or opioid use disorder after opioid initiation, whether medical or non-medical. Similarly, the definition of opioid use disorder has evolved over the years.

Further, in many cases incidence and prevalence are calculated based on assumptions made by researchers. For instance, in an Annual Review of Public Health article co-authored by Dr. Kolodny, a 2010 study is cited that found 26% of chronic pain patients met the criteria for opioid dependence and 35% met the criteria for opioid use disorder. This seems to be the source of the 25% claim used by Kolodny in the Oklahoma opioid trial.

But the 2010 study doesn’t distinguish between incidence and prevalence. It is also not clear how many of the surveyed pain patients had an opioid use disorder diagnosis before the onset of medical opioid therapy.

A similar critique can be levied against the authors of a 1980 letter in The New England Journal of Medicine that claimed opioid addiction was rare in pain patients. Some have claimed publication of the letter helped launch the opioid crisis. 

The problem with all of these studies is that they are retrospective in nature, limited to a particular patient population, and constrained by the diagnostic criteria in use at the time. And the estimates derived from such studies do not necessarily implicate or exonerate Johnson & Johnson.

Moreover, it is possible that addiction rates have varied over time and were influenced by factors that were not yet understood or even known. For example, recent research has found an association between opioid overdoses and drug diversion among family and friends, cold weather, altitude above sea level, and medical cannabis legalization.

The NIH work that Dr. Volkow refers to in her Opioid Watch interview works to account for all of these factors. So as Volkow stated last year, the “best and most recent estimate" stands at about eight percent. Improved public health surveillance, epidemiological research, and patient monitoring may shift this number up or down, and will increase confidence in the estimate.

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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.

How Opioid Critics and Law Firms Profit 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.  

“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.”

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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.”

Lawyers for Johnson & Johnson have opened a window into a profitable sideline Kolodny has as a paid consultant and expert witness for law firms involved in opioid litigation.

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.

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

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 $17.5 billion being sought from Johnson & Johnson, Nix Patterson’s share could theoretically add up to nearly $2.5 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 a paid 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 — even though PROP is not a registered charity. The identity of PROP’s donors and the size of their donations have never been disclosed.

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.

(Editor’s note: In an earlier version of this article, PNN incorrectly reported that Kolodny’s work in opioid litigation was not properly disclosed in two 2017 articles published by the Journal of the American Medical Association (JAMA). Kolodny’s work in opioid litigation apparently didn’t begin until after those articles were published and was disclosed in an April 2018 JAMA article. PNN regrets the error.

On September 4, 2019 Kolodny changed two of his JAMA disclosure statements to include his work as a paid expert in malpractice lawsuits. “I received compensation for work as an expert in malpractice litigation involving opioid prescribing. When the articles were first published, I did not believe this work could be perceived as a potential conflict of interest. My view has since changed. In the spirit of full transparency, I am requesting a correction to my disclosure statements.”)

Kolodny testified in the Oklahoma trial that he also did some consulting for attorney Linda Singer at Cohen Milstein, which The New York Times profiled in 2014 as a politically influential law firm that was laying the groundwork for opioid lawsuits around the country. Singer was the lead outside counsel for the City of Chicago and Santa Clara County, California, two of the first jurisdictions to file opioid lawsuits.

“The lawsuits follow a pattern: Private lawyers, who scour the news media and public records looking for potential cases in which a state or its consumers have been harmed, approach attorneys general. The attorneys general hire the private firms to do the necessary work, with the understanding that the firms will front most of the cost of the investigation and the litigation. The firms take a fee, typically 20 percent, and the state takes the rest of any money won from the defendants,” the Times reported.

Singer left Cohen Milstein in 2017 to join Motley Rice, yet another law firm that specializes in healthcare litigation. PNN was unable to verify whether Kolodny was still on the payroll of Cohen Milstein, Motley Rice or any other law firms. He refused to discuss 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 disclosed, however, which law firms Fugh-Berman works for, what cases she is working on, or how much she is paid.

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.

(Update: In testimony in California on August 15, 2019, Fugh-Berman said she billed $500 an hour for her testimony in a pelvic mesh liability trial of Johnson & Johnson. She received about $120,000 for her work on the case to date.)

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 OpenSecrets.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 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 (APS) — are named as defendants in opioid lawsuits filed by Simmons Hanly. The APS recently filed for bankruptcy, citing the high cost of defending itself against “meritless” law suits.

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 paid 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.” 

Lessons from 'American Overdose' on the Opioid Crisis

By Roger Chriss, PNN Columnist

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

McGreal summarizes his ideas with an indictment of American culture.

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

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

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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.