Some Background on the Potential Purdue Settlement

by
Bill Haskell
My articles My booksMy videos
Follow on:

I do not believe this (below) to be long. Then I am not the one who may choose to read it. Lawsuit by Pierce County against various drug distributors and manufacturers, In this instance, I am going to guess they are talking about Opioid pills such as Purdue’s Oxycontin. Do not confuse this with the Jick and Porter letter (which I will follow-up on) and the 2017 article A 1980 Letter on the Risk of Opioid Addiction | NEJM. I am interested in the erroneous citations using the Jick and Porter letter considering the safety of prescribing opioids. Seventy-two percent alleged addiction was rare in patients treated with opioids.

Below, you will read about three doctors or “Key Opinion Leaders” (or “KOLs,”) and how they handled prescribing Oxycontin, etc. If you walk away after reading this without saying “wow,” then I missed my goal or you are thickheaded. Much of this is a C&P straight from what was filed by Pierce County in the US District Court (Federal) Western District of Washington at Tacoma. My litigation attorney friend Jack will probably comment. Don’t beat him up.

Taken from: Pierce County Amended Complaint 4829-7649-5461 v.2.docx, piercecountywa.gov

UNITED STATES DISTRICT COURT WESTERN DISTRICT OF WASHINGTON AT TACOMA

PIERCE COUNTY,
Plaintiff,
versus
PURDUE PHARMA, L.P.; PURDUE; PHARMA, INC.; THE PURDUE FREDERICK COMPANY, INC.; ENDO HEALTH SOLUTIONS INC.; ENDO PHARMACEUTICALS, INC.; JANSSEN PHARMACEUTICALS, INC.; JOHNSON & JOHNSON; TEVA PHARMACEUTICALS INDUSTRIES, LTD.; TEVA PHARMACEUTICALS USA, INC.; CEPHALON, INC.; ALLERGAN PLC f/k/a ACTAVIS PLC; WATSON PHARMACEUTICALS, INC n/k/a ACTAVIS, INC.; WATSON LABORATORIES, INC.; ACTAVIS LLC; ACTAVIS PHARMA, INC. f/k/a WATSON PHARMA, INC; MALLINCKRODT PLC; MALLINCKRODT, LLC; CARDINAL HEALTH, INC.; MCKESSON CORPORATION; AMERISOURCEBERGEN DRUG CORPORATION; and JOHN AND JANE DOES 1 THROUGH 100, INCLUSIVE

Defendants Purdue, Endo, Janssen, Cephalon, Actavis, and Mallinckrodt are collectively referred to as the “Manufacturing Defendants.”

McKesson, AmerisourceBergen, and Cardinal Health (together “Distributor Defendants”) account for approximately 85% of all drug shipments in the United States.

Pages 55 of 147 to 59 of 147 Doctors (3 examples) advocating for Manufacturing Defendants’ opioids.

187. The Manufacturing Defendants retained highly credentialed medical professionals to promote the purported benefits and minimal risks of opioids. Known as “Key Opinion Leaders” or “KOLs,” these medical professionals were often integrally involved with the front groups described above. The Manufacturing Defendants paid these KOLs substantial amounts to present at Continuing Medical Education (“CME”) seminars and conferences, and to serve on their advisory boards and on the boards of the various front groups.
188. The Manufacturing Defendants also identified doctors to serve as speakers or attend all-expense-paid trips to programs with speakers.⁸⁵ The Manufacturing Defendants used these trips and programs—many of them lavish affairs—to incentivize the use of opioids while downplaying their risks, bombarding doctors with messages about the safety and efficacy of opioids for treating long-term pain. Although often couched in scientific certainty, the Manufacturing Defendants’ messages were false and misleading, and helped to ensure that millions of Americans would be exposed to the profound risks of these drugs.
189. It is well documented that this type of pharmaceutical company symposium influences physicians’ prescribing, even though physicians who attend such symposia believe that such enticements do not alter their prescribing patterns.⁸⁶ For example, doctors who were invited to these all-expenses-paid weekends in resort locations like Boca Raton, Florida, and Scottsdale, Arizona, wrote twice as many prescriptions as those who did not attend.⁸⁷
190. The KOLs gave the impression they were independent sources of unbiased information, while touting the benefits of opioids through their presentations, articles, and books. KOLs also served on committees and helped develop guidelines such as the 2009 Guidelines described above that strongly encouraged the use of opioids to treat chronic pain.
191. One of the most prominent KOLs for the Manufacturing Defendants’ opioids was Dr. Russell Portenoy. A respected leader in the field of pain treatment, Dr. Portenoy was highly influential. Dr. Andrew Kolodny, cofounder of Physicians for Responsible Opioid Prescribing, described him “lecturing around the country as a religious-like figure. The megaphone for Portenoy is Purdue, which flies in people to resorts to hear him speak. It was a compelling message: ‘Docs have been letting patients suffer; nobody really gets addicted; it’s been studied.’”⁸⁸
192. As one organizer of CME seminars, who worked with Portenoy and Purdue, pointed out, “had Portenoy not had Purdue’s money behind him, he would have published some papers, made some speeches, and his influence would have been minor. With Purdue’s millions behind him, his message, which dovetailed with their marketing plans, was hugely magnified.”⁸⁹
193. In recent years, some of the Manufacturing Defendants’ KOLs have conceded that many of their past claims in support of opioid use lacked evidence or support in the scientific literature.⁹⁰ Dr. Portenoy himself specifically admitted that he overstated the drugs’ benefits and glossed over their risks, and that he “gave innumerable lectures in the late 1980s and ‘90s about addiction that weren’t true.”⁹¹ He mused, “Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinformation? Well, against the standards of 2012, I guess I did . . . We didn’t know then what we know now.”⁹²
194. Dr. Portenoy did not need “the standards of 2012” to discern evidence-based science from baseless claims, however. When interviewed by journalist Barry Meier for his 2003 book, Pain Killer, Dr. Portenoy was more direct: “It was pseudoscience. I guess I’m going to have always to live with that one.”⁹³
195. Dr. Portenoy was perhaps the most prominent KOL for prescription opioids, but he was far from the only one. In fact, Dr. Portenoy and a doctor named Perry Fine co-wrote A Clinical Guide to Opioid Analgesia, which contained statements that conflict with the CDC’s 2016 Guideline for Prescribing Opioids for Chronic Pain, such as the following examples regarding respiratory depression and addiction.

At clinically appropriate doses, . . . respiratory rate typically does not decline.
Tolerance to the respiratory effects usually develops quickly, and doses can be
steadily increased without risk.
Overall, the literature provides evidence that the outcomes of drug abuse and
addiction are rare among patients who receive opioids for a short period (ie, for
acute pain) and among those with no history of abuse who receive long-term
therapy for medical indications.⁹⁴

196. Dr. Perry Fine is a Professor of Anesthesiology at the University of Utah School of Medicine’s Pain Research Center. He has served on Purdue’s advisory board, provided medical legal consulting for Janssen, and participated in CME activities for Endo, along with serving in these capacities for several other drug companies. He co-chaired the APS-AAPM Opioid Guideline Panel, served as treasurer of the AAPM from 2007 to 2010 and as president of that group from 2011 to 2013, and was also on the board of directors of APF.⁹⁵
197. In 2011, he and Dr. Scott Fishman, discussed below, published a letter in JAMA called “Reducing Opioid Abuse and Diversion,” which emphasized the importance of maintaining patient access to opioids.⁹⁶ The editors of JAMA found that both doctors had provided incomplete financial disclosures and made them submit corrections listing all of their ties to the prescription painkiller industry.⁹⁷
198. Dr. Fine also failed to provide full disclosures as required by his employer, the University of Utah. For example, Dr. Fine told the university that he had received under $5,000 in 2010 from Johnson & Johnson for providing “educational” services, but Johnson & Johnson’s website states that the company paid him $32,017 for consulting, promotional talks, meals and travel that year.⁹⁸
199. In 2012, along with other KOLs, Dr. Fine was investigated for his ties to drug companies as part of the Senate investigation of front groups described above. When Marianne Skolek, a reporter for the online news outlet Salem-News.com and a critic of opioid overuse, wrote an article about him and another KOL being investigated, Dr. Fine fired back, sending a letter to her editor accusing her of poor journalism and saying that she had lost whatever credibility she may have had. He criticized her for linking him to Purdue, writing, “I have never had anything to do with Oxycontin development, sales, marketing or promotion; I have never been a Purdue Pharma speaker”—neglecting to mention, of course, that he served on Purdue’s advisory board, as the JAMA editors had previously forced him to disclose. ⁹⁹
200. Another Utah physician, Dr. Lynn Webster, was the director of Lifetree Clinical Research & Pain Clinic in Salt Lake City from 1990 to 2010, and in 2013 was the president of AAPM (one of the front groups discussed above). Dr. Webster developed a five-question survey he called the Opioid Risk Tool, which he asserted would “predict accurately which individuals may develop aberrant behaviors when prescribed opioids for chronic pain.”¹⁰⁰ He published books titled The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us and Avoiding Opioid Abuse While Managing Pain.
201. Dr. Webster and the Lifetree Clinic were investigated by the DEA for overprescribing opioids after twenty patients died from overdoses. In keeping with the opioid industry’s promotional messages, Dr. Webster apparently believed the solution to patients’ tolerance or addictive behaviors was more opioids: he prescribed staggering quantities of pills. Tina Webb, a Lifetree patient who overdosed in 2007, was taking as many as thirty-two pain pills a day in the year before she died, all while under doctor supervision.¹⁰¹ Carol Ann Bosley, who sought treatment for pain at Lifetree after a serious car accident and multiple spine surgeries, quickly became addicted to opioids and was prescribed increasing quantities of pills; at the time of her death, she was on seven different medications totaling approximately 600 pills a month.¹⁰² Another woman, who sought treatment from Lifetree for chronic low back pain and headaches, died at age forty-two after Lifetree clinicians increased her prescriptions to fourteen different drugs, including multiple opioids, for a total of 1,158 pills a month.¹⁰³
202. By these numbers, Lifetree resembles the pill mills and “bad actors” that the Manufacturing Defendants blame for opioid overuse. But Dr. Webster was an integral part of Defendants’ marketing campaigns, a respected pain specialist who authored numerous CMEs sponsored by Endo and Purdue. And the Manufacturing Defendants promoted his Opioid Risk Tool and similar screening questionnaires as measures that allow powerful opioids to be prescribed for chronic pain. Even in the face of patients’ deaths, Dr. Webster continues to promote a pro-opioid agenda, even asserting that alternatives to opioids are risky because “[i]t’s not hard to overdose on NSAIDs or acetaminophen.”¹⁰⁴ He argued on his website in 2015 that DEA restrictions on the accessibility of hydrocodone harm patients, and in 2017 tweeted in response to CVS Caremark’s announcement that it will limit opioid prescriptions that “CVS Caremark’s new opioid policy is wrong, and it won’t stop illegal drugs.”¹⁰⁵

Doctors involved in this may tell you early on they did not know. The Jick and Porter brief report on the use of opioids in a hospital setting was safe and addiction was rare. Now remove the words “in a hospital setting” and how does the meaning change? This was used extensively to promote Purdue’s new product OxyContin.

“Of the 608 articles, the authors of 491 articles (80.8%) did not note that the patients who were described in the letter were hospitalized at the time they received the prescription, whereas some authors grossly misrepresented the conclusions of the letter (Section 3 in the Supplementary Appendix).”

References:

From the Boy Scouts to the Catholic Church, an upcoming Supreme Court ruling may mean some victims won’t see their day in court, msn.com

Addiction Rare in Patients Treated with Narcotics, NEJM

A 1980 Letter on the Risk of Opioid Addiction, NEJM

nejmc1700150, appendix.pdf