Kolodny: Critics of CDC Opioid Guideline ‘Twisting the Facts’

By Pat Anson, PNN Editor

The founder of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP) says his organization played only a minor role in drafting the CDC opioid guideline and claims much of the controversy over the guideline was stirred up by pain organizations funded by the pharmaceutical industry.

“Not every group that has harmful advocacy is funded by industry, but the vast majority are. The ones that are not funded by industry work arm-in-arm with industry funded groups,” said Dr. Andrew Kolodny. “They have an agenda. A lot of individuals, journalists, organizations that have weighed in on the opioid crisis have an agenda. And they will try and twist the facts to fit their agenda.”

Kolodny spoke for over an hour Tuesday during a webinar hosted by PharmedOut, a program at Georgetown University that seeks to expose deceptive marketing in healthcare. The webinar was billed as an effort to refute “False Narratives & Manufactured Controversies about the Opioid Crisis,” but it turned into a rambling dialogue by Kolodny that gaslighted pain sufferers, doctors, patient advocates and anyone else critical of the CDC guideline.

“Much of the controversy or the critique of the guideline, almost all of it, was focused on the secretive way in which the guideline had been drafted, not on the actual recommendations. They seemed to stay clear from attacking recommendations, almost all of which were pretty benign,” said Kolodny.

Although voluntary and only intended for primary care physicians, the CDC guideline has become the “standard of care” in the United States for treating pain, with millions of patients taken off opioids or reduced to lower doses in the name of preventing addiction and overdoses.

Many patients say their pain and quality of life are now significantly worse, they have a hard time finding doctors, and some have turned to alcohol and illegal drugs for pain relief. The opioid crisis also continues to grow worse, with a record number of fatal overdoses last year – most of them caused by illicit fentanyl and other street drugs, not prescription opioids.

Even the CDC has recognized that its 2016 guideline has caused “unintended harms,” and the agency is now in the process of updating and possibly expanding its recommendations.

Kolodny brushed aside many of those concerns and instead focused on deflecting attention away from PROP –- at various times blaming Purdue Pharma, the Koch brothers and the Washington Legal Foundation for “manufacturing a controversy around the CDC recommendations.”

“To try and make the guideline controversial, the messaging came out that the guideline has been secretly written by PROP. We started to see mentions in social media and publications describing PROP as a fringe group or as anti-opioid zealots. So the messaging was that the CDC relied on this fringe, anti-opioid zealot group to secretly write the guideline,” Kolodny said. 

As PNN has reported, the CDC guideline was in fact drafted in secret, with no public hearings and little input from patients or pain management experts. Only when threatened with a lawsuit by the Washington Legal Foundation and a congressional investigation did the CDC open up the guideline process to public scrutiny and disclose the identities of its advisors and consultants.

At least five PROP board members were involved in drafting the guideline, although Kolodny claimed there were only three in Tuesday’s webinar.  PROP President Jane Ballantyne and Vice-President Gary Franklin were members of a key advisory panel; David Tauben was on the guideline’s peer review panel; and Kolodny and David Juurlink were on a stakeholder review group.

While technically true that PROP did not write the guideline, PROP had input and key relationships within the CDC. Dr. Roger Chou, one of the guideline authors, has collaborated with PROP members on several occasions, such as writing an op/ed with Ballantyne that encouraged doctors to consider tapering “every patient receiving long term opioid therapy.”

Koldony is also a longtime associate and friend of then CDC Director Thomas Frieden, and has co-authored op/eds with Frieden, including one that recommended taking all high-dose opioid medications off the market.

We may never know the true extent of these relationships, because CDC has refused to disclose key material about its guideline deliberations. The agency’s response to a Freedom of Information Act (FOIA) request from PNN was to send us nearly 1,500 pages of documents that were heavily redacted or scrubbed of information. Over 1,200 pages were completely blank.

The agency cited “deliberative process privilege” and “personal privacy” as reasons to withhold the information.

Friendly Questions

Kolodny took only a handful of friendly, softball questions during the webinar, most of them from students at Georgetown University who are interning at PharmedOut. Several pain patients also submitted more critical questions, but they were not passed on to Kolodny.

Although opioid prescriptions in the U.S. have been declining since their peak in 2011, Kolodny says they need to go down further, even though nearly 85% of overdose deaths in the U.S. involve illicit fentanyl and other street drugs.

“We continue to massively overprescribe,” he said. “Opioids are not good treatments for chronic pain. It’s not true that more cautious prescribing somehow jeopardizes compassionate care for chronic pain. Compassionate care for chronic pain really demands more cautious prescribing.”

Kolodny is quick to blame “industry funded groups” for opposition to the CDC guideline, but PROP has remained secretive about its own funding. PROP uses a loophole in IRS regulations that allows it to hide behind front organizations such as the Steve Rummler Hope Network as its “fiscal sponsor.” Because it is not registered as a nonprofit — although it sometimes claims to be one — PROP has never filed a federal or state tax return and is not required to disclose anything about its funding or spending.

Kolodny currently works in opioid research at Brandeis University, but has a lucrative sideline testifying as an expert witness in opioid litigation and malpractice lawsuits. He was paid $725 an hour for his testimony during Oklahoma’s lawsuit against Johnson & Johnson, and may have collected as much as $500,000 for that case alone.

Dr. Adriane Fugh-Berman, who is a PROP board member and Director of PharmedOut, is also a paid expert witness and earned $500 an hour for her testimony in another trial involving Johnson & Johnson. She reportedly received about $120,000 for her work in that case. Like PROP, PharmedOut does not disclose its funding or donors.

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.”

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

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.