Senator Reveals Results Of Opioid Inquiry Into Fentanyl Maker Insys

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Senator Reveals Results Of Opioid Inquiry Into Fentanyl Maker Insys

By Paul Gaita 09/12/17

An investigative report from Senator Claire McCaskill claims that Insys pushed employees to "increase their ratio of approvals for the drug."

Senator Claire McCaskill
Senator Claire McCaskill Photo via YouTube

An investigation by a leading Democratic senator into pharmaceutical companies' sales and marketing practices has yielded an audio file that suggests that a representative from a major drug manufacturer may have misrepresented information about a product in order to allow coverage of a more expensive and potentially dangerous opioid.

Senator Claire McCaskill (D-Missouri) released the first report from her investigation into opioid manufacturers, which claims that Insys Therapeutics—the manufacturers of Subsys, a powerful fentanyl drug approved by the FDA for severe or "breakthrough" cancer pain—pushed its employees to "increase their ratio of approvals" for the drug, even for "inappropriate, off-label uses" including back pain and migraines, as a press release from McCaskill's office alleges. 

The report included an audio recording of a phone conversation between an Insys employee and a pharmacy benefit manager in which the employee appears to mislead the manager about her relationship to a patient, Sarah Fuller, as well as the type of pain she was experiencing, in order to secure approval for Subsys.

Court documents later stated that the patient, who had a history of narcotic addiction, died due to an "adverse reaction to prescription medications," though it was not clarified whether Subsys was the drug in question. 

According to a story on the report and audio file by Ars Technica, Fuller suffered from back and neck pain and fibromyalgia, and was treating the conditions with opioids prescribed by her doctor. The story states that in January 2015, Fuller and her doctor met with a representative from Insys to discuss adding Subsys to her pain management plan, despite a cost to Fuller of more than $20,000 per month.

That same month, an Insys rep is alleged to have called Fuller's prescription benefits company, Envision Pharmaceutical Services, to get coverage for the drug. The benefit manager initially declined the prescription request, after which the Insys rep appears to suggest that Fuller's doctor is treating her for breakthrough cancer pain.

In the press release, McCaskill's office says that the call took place during a period in which Insys is alleged to have placed pressure on its employees to boost their approval rates for Subsys prescriptions. The senator's release quotes an internal presentation dated 2012 which reportedly laid out a "Subsys Brand Plan" and six strategies, including one that advised employees to "mitigate prior authorization barriers."

During this time period, McCaskill's report states that the value of Insys' company stock rose 296% over three years.

"There is extensive evidence that Insys aggressively pressured its employees and the entire medical system to increase the use of a fentanyl product during a national epidemic that was taking the lives of tens of thousands of Americans a year in order to make more money," McCaskill alleged in a statement. "Their attempts to manipulate the prescription approval process for this drug appear to have been systemic, and anyone responsible for this manipulation deserves to be prosecuted."

In addition to the report and audio file, McCaskill released a letter from Saeed Motahari, who was appointed president and CEO of Insys in March 2017 after a tenure as president of Purdue Pharma. Motahari noted in the letter that the company has turned over more than 90% of its staff, and has established new standards and practices to assure that "certain mistakes and unacceptable actions of former Insys employees" will not happen under his watch.

"We passionately believe that the company has taken steps to ensure that we will not repeat the mistakes of the past," he wrote.

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