Opioid maker bent rules to get drug to patients, Senate report says

Opioid maker bent rules to get drug to patients, Senate report says”

Insys Therapeutics faked cancer patients in order to boost sales of its drug Subsys, a sprayable form of the opioid painkiller fentanyl, according to a federal indictment and ongoing congressional investigation by Sen.

Senator Claire McCaskill, D-Mo., will hold a roundtable on September 12 with the Senate Homeland Security and Governmental Affairs Committee to present details on Insys Therapeutics' sales and marketing strategies, among other opioid manufacturers.

Late previous year, federal prosecutors criminally charged the company's former CEO and five other executives with fraud and racketeering charges related to Subsys. Since the drug has a high cost and insurers won't pay for it without advanced approval, called "prior-authorization", Insys had to find a way around this.

Insys is now under a congressional investigation led by Missouri Senator Claire McCaskill (D), who recently discovered that the company doctored medical records in order to promote a highly unsafe fentanyl spray called Subsys.

The details of both the phone call and the report help flesh out what is already a disturbing picture of unchecked pharmaceutical marketing that has emerged from a growing raft of documents in criminal cases and civil lawsuits involving the beleaguered drug maker. An employee would then call the insurer and its affiliates to persuade them into approving the payment for the prescription. The employee claims that they are "with" the patient's doctor's office and pretends to be flipping through the patient's transcript and says out loud that Subsys is "intended for the management of breakthrough cancer pain". To work around that, Insys allegedly called insurance companies and tricked them into okaying the drug for non-cancer patients.

This technique worked on countless occasions. That's how Subsys fell into the hands of Sarah Fuller, a New Jersey resident who was given the spray to treat her fibromyalgia and back pain. The insurance companies were under the impression they were talking with someone at the doctor's office based on a carefully written script that the Insys employees read from. The woman died about in 2016 from a Subsys overdose.

Saeed Motahari took over as CEO of Insys in April and in a letter to McCaskill's office he wrote that, "Over the past several years, Insys has actively taken the appropriate steps to place ethical standards of conduct and patient interests at the heart of our business decisions". The six executives that were indicted in December have submitted not guilty pleas while other lower level employees have admitted their guilt in the scheme.

The defendants have all pled not-guilty to the charges, unlike their former colleague Karen Hill. Wednesday's report is part of a broader probe into opioid manufacturers including Purdue, Johnson & Johnson, Mylan, and Depomed.

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