WASHINGTON - U.S. Senator Claire McCaskill, the top-ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee, today released the latest product of her wide-ranging investigation into opioid manufacturers and distributors. “Fueling an Epidemic: Exposing the Financial Ties Between Opioid Manufacturers and Third Party Advocacy Groups” describes how manufacturers of opioids have made significant financial investments into third party organizations—groups which in turn have engaged in pro-opioid advocacy over a long period of time, including through guidance minimizing the risks of opioid addiction and the endorsement of opioid use for the long-term treatment of chronic pain—an approach not backed up by medical science.
READ THE REPORT: Fueling an Epidemic: Exposing the Financial Ties Between Opioid Manufacturers and Third Party Advocacy Groups
McCaskill’s is the first Congressional report on these critical relationships, and illustrates an under-investigated dimension of the connections between the pharmaceutical industry, the medical community, government, and the general public that ultimately generated a national public health crisis.
“The pharmaceutical industry spent a generation downplaying the risks of opioid addiction and trying to expand their customer base for these incredibly dangerous medications and this report makes clear they made investments in third-party organizations that could further those goals,” McCaskill said. “These financial relationships were insidious, lacked transparency, and are one of many factors that have resulted in arguably the most deadly drug epidemic in American history.”
The report’s key findings include:
- Contributions from five leading opioid manufacturers of nearly $9 million to 14 third party advocacy organizations over a five year period.
- Additional payments of $1.6 million from the five manufacturers to physicians affiliated with these groups between 2013 and the present.
- Several of the groups profiled received the majority of their outside contributions and grants for certain years between 2012 and 2017 from opioid manufacturers.
- Initiatives from the groups in this report often echoed and amplified messages favorable to increased opioid use—and ultimately, the financial interests of opioid manufacturers. These groups have issued guidelines and policies minimizing the risk of opioid addiction and promoting opioids for chronic pain, lobbied to change laws directed at curbing opioid use, and argued against accountability for physicians and industry executives responsible for overprescription and misbranding. For example:
- According to lawsuits filed across the country, the American Academy of Pain Medicine, which received almost $1.2 million from the five manufacturers under investigation between 2012 and 2017, issued a 2009 patient guide stating that “opioids are rarely addictive when used properly for the management of chronic pain.”
- The Washington Legal Foundation criticized 2016 Centers for Disease Control and Prevention (CDC) prescribing guidelines that recommended limits on opioid prescriptions for chronic pain—the first national standards for prescription opioids and a key federal response to the ongoing epidemic—as procedurally flawed and tainted by bias—and also received $500,000 from Purdue Pharma between 2012 and 2016. Notably, a majority of the groups profiled in McCaskill’s report strongly criticized these guidelines.
- The Academy of Integrative Pain Management, which received over $1.2 million from the five manufacturers, has partnered with the American Cancer Society Cancer Action Network on opioid-related lobbying in 18 states as of 2016, including efforts to block limits on opioid prescribing.
“The fact that these same manufacturers provided millions of dollars to the groups described [in this report] suggests, at the very least, a direct link between corporate donations and the advancement of opioids-friendly messaging. By aligning medical culture with industry goals in this way, many of the groups described in this report may have played a significant role in creating the necessary conditions for the U.S. opioids epidemic,” the report states.
McCaskill’s report also details a troubling lack of transparency surrounding the advocacy organizations. Due to their classification under the U.S. tax code, the groups profiled in the report have no obligation to disclose their donors publicly. As a result, each group maintains different levels of transparency regarding its financial connections to the pharmaceutical industry and has no obligation to publicly disclose their funding sources. These organizations have the ability to selectively disclose donors, donations, and other support—or no information at all. No organization profiled in McCaskill’s report provides an online list linking donors, their specific donations, and the projects or events benefiting from each donation for each of the years between 2012 and 2017—an area in which McCaskill says a legislative solution is necessary.
“The financial relationships between these groups and opioid manufacturers should be clear to the general public,” McCaskill said. “We passed a law ensuring the public had information on payments to doctors by pharmaceutical companies, and I can’t imagine why the same shouldn’t be done in this space.”
Earlier this year, McCaskill launched an investigation into opioid manufacturers—the most comprehensive Congressional investigation into the crisis to date—when she requested information related to sales and marketing materials, internal addiction studies, details on compliance with government settlements and donations to third party advocacy groups from major opioid manufacturers. She expanded her investigation, requesting documents and information from opioid manufacturers Mallinckrodt, Endo, Teva, and Allergan, while a request to McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc., focused on their distribution of opioid products. In September, McCaskill announced the first round of findings, detailing systemic manipulation of the prior authorization process by Insys Therapeutics. McCaskill is currently working on legislation to strengthen the Drug Enforcement Administration’s opioid enforcement abilities. After media reports indicated that the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 had dramatically restricted the agency’s ability to crack down on opioid distributors suspected of wrongdoing, McCaskill introduced a bill to repeal the law, and she led a Senate roundtable on her bill.