A major pharmaceutical company lied and bypassed normal processes to push opioids on to patients who didn't need them, according to a new report released Wednesday by Sen. Claire McCaskillClaire Conner McCaskillLobbying world Ex-Rep. Akin dies at 74 Republicans may regret restricting reproductive rights MORE (D-Mo.)
The report is the first product of an investigation into opioid manufacturers and distributors led by McCaskill in her role as the ranking Democrat on the Senate's Homeland Security and Governmental Affairs Committee.
In one example, a representative of Insys Therapeutics Inc. misled a pharmacy benefit manager (PBM) into approving a payment for Subsys, a highly addictive fentanyl opioid meant to help manage cancer pain, the report says.
“We agree with Senator McCaskill that the opioid epidemic must be addressed and we have therefore cooperated extensively with her investigation," the company said in a statement to The Hill. "We respectfully disagree with certain characterizations in the staff report released today. The report relates to activities of former employees of our company and matters that the company has addressed in its own efforts and in connection with investigations by the Department of Justice and state attorney general offices."
"We continue to reiterate our efforts to be part of the solution to the opioid crisis by focusing on assisting patients and developing alternative pain medications in our research and development programs," the statement continued.
High-risk drugs like Sybsys often need the approval of PBMs before a claim can be sent to an insurer.
In audio released by McCaskill's office, an Insys employee asks a PBM to order Subsys for a patient named Sarah Fuller.
The employee claimed to be from a doctor’s office to get the drug prescribed, McCaskill's office said.
Fuller died 14 months later at the age of 32 due to complications related to the drug, the report says.
"This recording suggests the Insys employee in question repeatedly misled Envision Pharmaceutical Services to obtain approval for Ms. Fuller’s Subsys treatment — heavily implying she was employed by the prescribing physician and misrepresenting the type of pain the patient was experiencing," the report says.
According to the report, that call occurred during a period in which Insys was "aggressively" pressuring employees to increase their rations of approvals, with the promise of financial incentives and bonuses.
“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—it’s hard to imagine anything more despicable,” McCaskill said 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.”
Insys is already facing multiple lawsuits over allegations that it defrauded insurers.