In a revelation that echoes the scandals of Purdue Pharma, Mallinckrodt, one of the largest sellers of prescription opioids in the US, has been thrust into the limelight. Recently, the company was compelled to release over 1.3 million internal documents, providing a rare glimpse into the tactics employed to shape medical and scientific opinion to boost opioid sales.

Mallinckrodt’s Rise and Strategies

From 2006 to 2012, Mallinckrodt dominated the US opioid market, selling nearly 40% of all opioid pills. Despite facing minimal public scrutiny compared to Purdue Pharma, Mallinckrodt’s operations had a profound impact on the opioid crisis. Their baby blue 30 mg oxycodone tablets, marked with “M30,” became so ubiquitous that counterfeits containing fentanyl still plague the streets today.

Despite legal challenges and two bankruptcy filings, Mallinckrodt has continued its operations. The company was ordered to pay $1.7 billion for misleading marketing practices but largely avoided full payment. The internal documents, made public, reveal a sophisticated strategy to influence doctors and shape the discourse around opioid use.

A Coordinated Effort to Influence

Mallinckrodt’s internal documents reveal a variety of tactics designed to increase opioid sales. These included designing continuing medical education (CME) courses, recruiting physicians as influencers, and planting articles in scientific journals. These efforts were aimed at portraying opioids as essential for both acute and chronic pain management, despite the growing addiction crisis.

Contracts with nearly 900 physicians and medical education companies show the extent of Mallinckrodt’s efforts to mold medical opinions. These contracts, totaling millions of dollars, aimed to position extended-release opioids like Exalgo and Xartemis as innovations in pain management. They also worked to mitigate concerns about addiction by promoting concepts like “pseudoaddiction,” where patients’ need for higher doses was framed as a symptom of under-treatment rather than addiction.

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Manipulating Medical Education and Opinion

A significant part of Mallinckrodt’s strategy involved creating and funding CME programs. For example, the “Remedies: Focus on Opioid Tolerance” program aimed to educate 10,000 physicians, eventually expanding to reach over 88,000 prescribers. These programs were designed to present Mallinckrodt’s products favorably while downplaying the risks associated with opioid use.

Key opinion leaders (KOLs) played a crucial role in this strategy. Physicians like Michael Brennan and Charles Argoff, who received substantial payments from Mallinckrodt, were instrumental in disseminating the company’s messages. These KOLs helped to normalize the use of high-dose opioids and to frame concerns about addiction as irrational fears or “opioid-phobia.”

Ghostwriting and Publication Planning

Mallinckrodt also engaged in ghostwriting and publication planning, strategically placing articles in medical journals to support their products. Contracts with medical education companies like MedLogix ensured that the company’s preferred narratives were widely disseminated. These ghostwritten articles often presented extended-release opioids as safer alternatives, despite a lack of supporting evidence.

One notable concept promoted by Mallinckrodt was “chronification,” the idea that untreated acute pain leads to chronic pain, which supposedly justified early and aggressive opioid treatment. This concept was featured in review articles and CME programs, further entrenching the use of opioids in pain management.

The Aftermath and Continuing Impact

Despite the scrutiny and legal battles, Mallinckrodt remains a significant player in the opioid market. In 2023, the company reported $262 million in opioid sales, a 25% increase from the previous year. The release of these documents has provided invaluable insight into the corporate strategies that contributed to the opioid crisis.

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The tactics revealed in Mallinckrodt’s internal documents highlight the broader issue of pharmaceutical influence on medical practice. By understanding these strategies, we can better address the root causes of the opioid epidemic and develop more effective policies to prevent similar crises in the future.

Conclusion

Mallinckrodt’s story is a stark reminder of the lengths to which pharmaceutical companies will go to protect and expand their market share, often at the expense of public health. The release of these documents underscores the need for greater transparency and accountability in the pharmaceutical industry. As we continue to grapple with the fallout from the opioid crisis, the lessons learned from Mallinckrodt’s playbook will be crucial in preventing future public health disasters.

Source and Authors

This article is based on an in-depth essay published in BMJ by Sergio Sismondo, a professor of Philosophy at Queen’s University in Ontario, Canada, and Maud Bernisson from the Institute for Science in Society at Radboud University, Nijmegen, Netherlands. Sismondo and Bernisson have meticulously analyzed nearly 900 contracts from the 1.3 million internal documents released by Mallinckrodt, revealing the extensive tactics used by the company to shape medical and scientific opinions.

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