Mallinckrodt Docs Reveal Tactics to Boost Opioid Sales, BMJ Finds

In a detailed investigation of Mallinckrodt’s internal documents, researchers uncovered an array of methods the pharmaceutical company allegedly used to influence doctors to prescribe its opioid medications. Over the past decade, the company has been embroiled in numerous lawsuits, accusing it of deceptive marketing practices to increase sales of its painkillers. Mallinckrodt, once the United States' leading producer of opioids like hydrocodone, hydromorphone, and oxycodone from 2006 into the early 2010s, denies any misconduct. However, the financial repercussions from settlements and fines have driven the company to file for bankruptcy twice, once in 2020 and again in 2023.

In the first bankruptcy case, more than a million internal documents were released to the public. The 2022 settlement concluded with Mallinckrodt agreeing to pay $1.7 billion to local and state governments, as well as individual victims of the opioid crisis—$1 billion of which was nullified in the second bankruptcy filing. The BMJ published a report on Monday revealing findings from researchers Sergio Sismondo, Ph.D., and Maud Bernisson, Ph.D., who scrutinized nearly 900 contracts within those documents. The report demonstrates concrete efforts backed by financial incentives.

The researchers discovered that the tactics employed aimed to persuade medical professionals that opioids, like those produced by Mallinckrodt, were effective and safe for long-term use. Mallinckrodt did not respond to requests for comment from Fierce Pharma Marketing or the researchers.

One of Mallinckrodt’s strategies was to recruit physicians to act as key opinion leaders (KOLs). These KOLs, after attending opulent weekend training sessions, would travel nationwide to give presentations to other doctors, reiterating the company's selling points for its opioid products. Additionally, KOLs played significant roles in other marketing efforts. For instance, some served as co-chairs for a continuing medical education course developed by Mallinckrodt, which promoted the benefits of opioids for pain management. By 2017, this course had reached over 88,000 physicians and provided education on increasing doses of long-acting opioids. The company's paid doctors were quoted in the course materials as downplaying the risks of addiction.

Furthermore, Mallinckrodt collaborated with these doctors to publish articles in medical journals, often ghostwritten by hired agencies, to convince the scientific community of the safety and necessity of opioids for pain treatment. For example, a 2013 review article cited in the BMJ report discussed how acute pain, if untreated, could evolve into chronic pain, suggesting that preventive opioid prescriptions could halt this progression. It also proposed that preventing chronic pain could reduce prolonged opioid exposure and potential abuse. However, a researcher cited by Sismondo and Bernisson pointed out that there is no substantial research supporting the claim that acute pain can be prevented from becoming chronic pain, but ceasing opioid use early can help prevent dependence.

A common theme in the KOLs’ presentations and the literature they endorsed was the downplaying of addiction risks. Many of these materials introduced the concept of "pseudoaddiction," which suggests that patients’ increased tolerance and physical dependence on opioids, resulting in a need for higher doses, is different from actual addiction. Despite their similar presentations, this distinction was used to differentiate between the two. A 2015 analysis of medical literature concluded that there was no empirical evidence to support pseudoaddiction as being distinct from addiction.

Leaning on this debatable distinction, the company marketed its extended-release opioids, including new versions of hydromorphone and oxycodone, as "abuse-deterrent." The strategies Sismondo and Bernisson highlighted were in use as opioid overdose deaths surged in the U.S., and doctors became more cautious about the drugs' addictive potential. The medical literature and physician endorsements cultivated by Mallinckrodt's marketing efforts provided a semblance of credibility to their products, particularly to busy physicians.

"This behavior is disturbing but not surprising," remarked Robert Steinbrook, M.D., director of the Health Research Group of Public Citizen, a consumer rights advocacy nonprofit. "It’s like they used every trick in the book."