WASHINGTON – U.S. Senator Claire McCaskill, the top-ranking Democrat on the Homeland Security and Governmental Affairs Committee, today released the latest report of her wide-ranging investigation into opioid manufacturers and distributors. “Fueling an Epidemic: Inside the Insys Strategy for Boosting Fentanyl Sales” documents Insys Therapeutics’ strategy for driving up the volume and strength of prescriptions for its fentanyl drug Subsys.
READ THE REPORT: Fueling an Epidemic: Inside the Insys Strategy for Boosting Fentanyl Sales
McCaskill’s report details Insys’ aggressive use of speakers programs—in which the company paid physicians to discuss Subsys with colleagues—and compensation programs—in which sales representatives were rewarded for aggressively pushing prescribers to give patients high-dosage prescriptions and punished for generating insufficient revenue—to boost sales for Subsys. Uniting these efforts, as an Insys national sales director wrote in October 2013, was a simple idea: “What drives us all? COMPENSATION.”
“Insys took an anything-goes approach to push sales higher and distorted the doctor-patient relationship with outside compensation, just so pharmaceutical executives could line their pockets—it’s disgusting,” McCaskill said. “How does it serve the public interest to allow a pharmaceutical company to tie sales incentives to the dosage strength of a highly addictive and potentially deadly drug? It’s unethical, it’s immoral, and it should be illegal.”
To compile the report, Homeland Security and Governmental Affairs Committee minority staff reviewed 1.6 million pages of internal Insys documents provided in response to a McCaskill request made last year. These documents include internal company reports, presentations, and communications that give an inside look at Insys’ strategy to boost sales for its fentanyl product.
The report’s key findings include:
· Insys established sales and marketing practices that formed the core of its approach to boosting Subsys sales: speakers programs in which the company paid physicians to discuss Subsys with colleagues, bonus structures for sales representatives that rewarded high-dosage prescriptions, accountability for representatives who failed to generate sufficient scripts, and the leveraging of personal relationships between physicians and representatives.
· Executives reminded representatives that strong Subsys dosages yielded higher bonus payouts, and managers encouraged representatives to “hold the customer accountable” when physicians and nurses failed to sustain or increase Subsys prescriptions—in part by leveraging personal relationships with these prescribers.
· Insys executives emphasized the importance of “owning” a physician—meaning that sales representatives should tightly monitor and control prescribing behavior—as well as the “return on investment” the company expected from speakers programs. Company managers similarly referred to Subsys patients as representing “annuities” for sales representatives.
· The company knew that its speakers programs suffered from serious deficiencies. A report by an outside consultant found that compliance issues with these programs included an absence of safety content, no clear disclosure of Insys sponsorship, and in at least one case, a guest list that indicated the program lacked a true educational purpose.
“[S]o long as both sales representatives and prescribers have strong financial incentives to boost prescriptions, simple greed will continue to distort the patient-physician relationship. As a result, this report represents a warning to policymakers seeking to prevent actors in the pharmaceutical industry from fueling the next public health crisis,” the report states.
McCaskill’s report also examines the cases of Heather Alfonso, a nurse practitioner from Connecticut, and Dr. Steven Simon, a physician practicing near Kansas City, Mo., both of whom exhibited high Subsys prescribing and received substantial payments from Insys. Alfonso was charged in 2015 with receiving kickbacks in connection with Subsys prescriptions under Medicare Part D and received approximately $83,000 for prescribing Subsys for her patients. Simon, a doctor based in Kansas, at one time ranked as the eighth-highest paid Subsys speaker in the United States, receiving over $230,000 from Insys between 2013 and 2016, and reportedly “prescribed more Subsys to people on Medicare Part D than any other Kansas practitioner.”
McCaskill issued a previous report on Insys Therapeutics last year, which detailed systemic manipulation of the prior authorization process by Insys to boost approvals for its highly addictive fentanyl drug Subsys, even for inappropriate, off-label uses. McCaskill’s broader investigation into opioid manufacturers—the most comprehensive Congressional investigation into the crisis to date—began early last year 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. Later, 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.
Earlier this year in February, McCaskill’s investigation released its second round of findings, exposing the financial ties between opioid manufacturers and third party groups, who often lobbied for pro-opioid policies after receiving contributions from pharmaceutical companies. In the wake of these discoveries, McCaskill introduced a bill in June to increase transparency and make sure opioid manufacturers report contributions to third party groups, which totaled almost $9 million between 2012 and 2017 for the companies and groups profiled in the February 2018 report. In July, McCaskill released another report as part of her investigation into opioid manufacturers, documenting how the “Big Three” pharmaceutical distribution companies together shipped around 1.6 billion dosage units of opioid products to Missouri alone between 2012 and 2017 and how their legally required suspicious order reporting for Missouri orders between 2012 and 2017 varied widely.