Opioid manufacturers funneled millions of dollars to patient advocacy groups that in turn issued “opioid friendly” guidance and policy recommendations, a congressional report has found.
Five major pharmaceutical manufacturers paid nearly $10 million to 14 patient advocacy groups and medical professional societies — as well as affiliated doctors — who were working on opioid-related issues between 2012 and 2017, according to the report released on Monday by Missouri Sen. Claire McCaskill, the Senate Homeland Security & Governmental Affairs Committee’s top Democrat.
After receiving the donations, these groups and and professional societies minimized the risk of addiction, promoted opioid use, lobbied against legislation that would curb abuse and fought attempts to hold physicians and industry executives responsible for over-prescribing opioids, the report maintains.
Most of the groups that received manufacturers’ money also opposed the first national standards for prescription pain killers issued by the Centers for Disease Control and Prevention in 2016, according to the report. The CDC’s guidelines recommended limits on opioid prescriptions for chronic pain — “a key federal response to the ongoing epidemic,” the report notes.
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It accuses the groups of playing “a significant role” in creating the conditions that led to America’s deadly opioids epidemic.
“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,” McCaskill said.
Some of the advocacy groups and professional societies mentioned in the report pushed back against the suggestion that receiving funds from manufacturers “amplified and reinforced messages favoring increased opioid use.”
Professional medical societies rely on numerous sources of revenue, including membership dues, registration fees, educational grants, sponsorships and the sale of exhibit space and advertising, said the American Academy of Pain Medicine in a statement.
“While the Academy has a policy that helps to ensure appropriate standards of accuracy are maintained in these transactional messages, it does not impose strict editorial control over them,” the statement said.
Regarding grants, the academy said accrediting standards “require that professional medical societies exclude industry from any influence, direct or indirect, over speakers and educational content.”
More than 42,000 Americans died from opioid overdoses last year alone. In Missouri, about 60 percent of drug overdose deaths in 2016 involved opioids, according to the Missouri Hospital Association.
McCaskill’s report is based on information voluntarily provided by the five opioid manufacturers and 14 advocacy groups to the committee at her request in 2017. Her committee staff warns in the report that the data might not capture the full extent of payments between manufacturers and advocacy groups and professional societies because the Internal Revenue Service does not require such groups to disclose their donors.
Purdue Pharma, one of the manufacturers, noted in a statement on Monday that it is no longer promoting opioids.
“We have supported third-party organizations, including with annual dues and unrestricted grants, that are interested in helping patients receive appropriate care,” said Robert Josephson, a Purdue spokesman.
He added: “We agree that the CDC’s Guideline is an important public health tool and have been directing prescribers to the Guideline and its recommendations since it issued in March 2016.”
A Mylan spokeswoman, Lauren Kashtan, said in a statement that the company’s top priority is the health and safety of its patients and that Mylan shares McCaskill’s concerns about the opioid crisis.
“Over the past few years,” Kashtan said, “Mylan made very limited payments to the American Pain Society solely as part of its participation in the organization’s annual conferences. We did not sponsor or fund any speakers or presentations at these conferences.”
The American Pain Society, a nonprofit professional organization that supports pain research and treatment, said it needed more time to review the document and craft a response.
Kashtan pointed out that Mylan manufactures a broad range of medications, only a small fraction of which contain opioids.
“While we have not received the report from Senator McCaskill, we believe the inquiry further underscores Mylan’s limited role in the manufacturing and marketing of opioids,” she said. “The inquiry should be inclusive of all opioid manufacturers, rather than a select few, and certainly those with more than 1 percent of the volume.”
A spokeswoman for another manufacturer, Janssen Global Services, said while the company cooperated with the senator and provided her staff with information, “we have not yet received a copy of her the final report and can’t comment on its content.”
Pharmaceutical company Depomed said in an email it “believes it has a strong Compliance program in place that oversaw the marketing, advertising and corporate sponsorship activities tied to the Lazanda and NUCYNTA franchises.”
The report cites Dr. Richard Payne, a physician affiliated with the Kansas City-based Center for Practical Bioethics, for “criticizing the CDC guidelines as the product of ‘conflicts of interests in terms of biases (and) intellectual conflicts’—while himself maintaining ‘financial links to numerous drug companies.’”
The center allegedly received $145,095 from Purdue and $18,000 from Janssen, for a total of $163,095 from companies that manufactured opioids, according to the report.
“Over the course of the last five years support from the pharmaceutical and device manufacturers represents less than 5 percent of the center’s operational support,” said John G. Carney, president and CEO of the center in a statement. “The center prides itself on the breadth, scope and diversity of our benefactors, and we will work to continuously maintain that distinction.”
Carney said he hadn’t seen McCaskill’s full report and so he couldn’t comment on it. But he pointed out that lives destroyed by substance abuse and by pain carry the same moral weight.
“We need better care and more safeguards,” he said. “We need more evidence-based approaches to treatment. We need more compassionate and comprehensive care, including effective alternative therapies and options not currently covered by insurance.”
The center will continue advocating both for patients “who live with chronic pain as well as those who live with substance use disorders,” he said.