Overland Park doctor was a model for opioid firm under indictment, Senate report says

By:  Andy Marso
Kansas City Star

Internal emails from an opioid manufacturer under federal indictment for an alleged kickback scheme show that company executives held Overland Park doctor Steven Simon as one of their models for their sales force.

The emails are included in a report released Tuesday by U.S. Senate committee staffers and provide new details about Simon’s relationship with Insys Therapeutics. The Arizona company’s former leaders face charges they used a physician speaker program to pay doctors for prescribing their fentanyl product Subsys, a highly concentrated opioid sprayed under the tongue.

An April 2013 email from Insys vice president of sales Alec Burlakoff listed Simon among the company’s Top 25 Subsys prescribers nationwide.

“These are our top performing customers,” Burlakoff wrote. “There are the clinicians that make us ‘tick.’ Although I know it is imperative to continuously create new prescribers for Subsys, I am still positive that the greatest opportunity for bonus dollars remain with the ‘big’ doctors whom (sic) are already sold on Subsys.”

Simon’s attorney, James Wyrsch, said Simon wasn’t part of any kickback scheme.

Wyrsch said Simon did some speaker training for Insys, but he had experience in prescribing quick-acting fentanyl long before the company developed Subsys, and he offered his patients a choice of painkillers.

“He didn’t ever prescribe anything pursuant to any incentives,” Wyrsch said.

The Senate report is the latest in a series of investigations into the opioid industry by U.S. Sen. Claire McCaskill, a Missouri Democrat, and her staff on the Senate Homeland Security and Governmental Affairs Committee.

Since 2017, The Star has reported much of the Senate report’s information on Simon — including that he was one of the top-paid Subsys speakers in the country from 2013-2015 and also the drug’s top prescriber in Kansas within the Medicare Part D program.

But the Senate report shows that he was involved with Insys in other ways too, starting just a few months after Subsys was approved by the Food and Drug Administration.

A March 2012 Insys email schedules him and 11 other clinicians for “In-Person Consultant Meetings” at JW Marriott Camelback, a luxury resort hotel and spa in Scottsdale, Ariz. A November 2012 email places him among 59 people invited to be part of a “Strategic Planning Ad(visory) Board.”

An October 2013 email lists Simon as a member of an Insys “Pain Practice Steering Committee” and a potential recruit for a “Pain Oral Solution Practice Committee.”

Simon has not been charged criminally. But FBI agents seized patient records last year from the clinic where he used to work, and four former patients and their families have filed civil suits against him claiming harm from aggressive Subsys prescribing.

Federal officials revealed in May that the Insys sales rep who worked with Simon, Torgny Andersson, was among several whistleblowers who had been helping with their criminal investigation for years.

The Senate report includes an email from May 2013 in which Burlakoff complained about doctors who prescribe quick-acting opioids other than Subsys, characterizing them as missed opportunities for the sales staff.

The email told them that they need to “own” those doctors within their sales territory and that anything less than 50 percent Subsys market share for rapid-onset opioids was unacceptable. Simon, according to Insys emails, was at more than 80 percent at the time.

Burlakoff is among the former Insys executives indicted for their roles in the alleged kickback scheme. They’ve pleaded not guilty, and their case is being heard in federal court in Boston.

Insys’ new leaders have said the company has undergone a complete culture change, and they agreed to a $150 million civil settlement with the U.S. Department of Justice in August.

But the Senate report expresses concern that “the next pharmaceutical company moving rapidly to establish market share in a crowded field may look to Insys as a model.

“And so 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.”