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.
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.
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.