Hydromorphone Hydrochloride

“This behavior is disturbing but not surprising,” Robert Steinbrook, M.D., director of the Health Research Group of the consumer rights advocacy nonprofit Public Citizen, said in the report. “It’s like they used every trick in the book.” In an analysis of thousands of Mallinckrodt’s internal documents, a pair of researchers uncovered a host of strategies that the pharma allegedly utilized to help sway doctors to prescribe its opioids. Throughout the last decade, Mallinckrodt has faced thousands of lawsuits accusing it of engaging in misleading marketing tactics to boost sales of its pain pills; the company was reportedly the U.S.’s largest producer of opioids, including hydrocodone, hydromorphone and oxycodone, for several years from 2006 to the early 2010s. The company has denied all wrongdoing, but the resulting settlements and fines have led it to file for bankruptcy twice, in 2020 and 2023. More than 1 million of the drugmaker’s internal documents were made public in the initial bankruptcy case, the 2022 settlement of which concluded with Mallinckrodt agreeing to pay $1.7 billion to local and state governments and individual victims of the opioid crisis—$1 billion of which was erased in the second bankruptcy filing. A report published in The BMJ on Monday details two researchers’ findings from digging through nearly 900 contracts included in that trove of documents, which “reflect concrete efforts backed up by payments.” According to Sergio Sismondo, Ph.D., and Maud Bernisson, Ph.D., the docs “outline a smorgasbord of tactics to achieve greater sales.” Tying those tactics together was an apparent effort to convince medical professionals that opioids like those sold by Mallinckrodt were not only effective treatments for acute and chronic pain but also safe for prolonged use. Mallinckrodt did not respond to requests for comment from Fierce Pharma Marketing nor from Sismondo and Bernisson. Among the strategies outlined in the contracts was Mallinckrodt’s recruitment of physicians to serve as key opinion leaders. After undergoing training at reportedly lavish weekend getaways, those KOLs would then be dispatched across the country to give presentations to their fellow doctors reiterating Mallinckrodt’s selling points for its opioid products. Those KOLs were also used to help carry out the pharma’s other marketing efforts. For example, some served as co-chairs of the continuing medical education course that Mallinckrodt developed to tout the benefits of opioids for pain management. The course, which ultimately reached more than 88,000 physicians by 2017, provided education on raising doses of long-acting opioids and quoted the company’s paid doctors as downplaying the risks of addiction, according to the report. Meanwhile, Mallinckrodt reportedly also worked with the doctors to place articles in medical journals—often ghostwritten by contracted agencies—aimed at persuading scientists and medical professionals of the safety and necessity of opioids to treat pain. For example, one such 2013 review article cited by the report’s authors discussed how acute pain is “commonly undertreated” and, if left untreated, can develop into chronic pain. It went on to suggest not only that prescribing opioids on a preventive basis could stop chronic pain in its tracks but also that “efforts to prevent chronic pain may eliminate extended exposure to opioids, which could, in turn, minimize drug abuse.” However, a chronic pain and opioid researcher cited by Sismondo and Bernisson noted that there’s no “good research” supporting the idea that acute pain can be prevented from turning into chronic pain, but that stopping opioid use promptly can help avoid dependence. A recurring theme in the presentations Mallinckrodt’s KOLs gave and the literature they put their names on was the minimizing of the possibility of addiction. According to the report, many of those materials relied on the concept of “pseudoaddiction,” which claims that patients’ increased tolerance of and physical dependence on opioids, and their resulting need for higher doses over time, is different from “true addiction,” despite their near-identical and easily confused presentations. Separately, a 2015 analysis of medical literature concluded that “no empirical evidence yet exists” to support the concept of pseudoaddiction as distinct from addiction. Nevertheless, bolstered by that nebulous distinction, the company went on to market its longer-acting, extended-release opioids—including novel versions of hydromorphone and oxycodone—as “abuse-deterrent.” The tactics that Sismondo and Bernisson found detailed in Mallinckrodt’s contracts were employed as opioid overdose deaths were skyrocketing in the U.S. and doctors were becoming more wary of the drugs and their potential for addiction. The medical literature and physician endorsements cultivated by the drugmaker would therefore have lent a reassuring measure of credibility to Mallinckrodt’s offerings, especially, as the authors noted, to particularly “busy physicians.” “This behavior is disturbing but not surprising,” Robert Steinbrook, M.D., director of the Health Research Group of the consumer rights advocacy nonprofit Public Citizen, said in the report. “It’s like they used every trick in the book.”