Arizona doctor says opioid maker's payments didn't affect medical decisions

PHOENIX — One of the three doctors — including one from Tucson — accused of prescribing opioids for money is denying he or the others did anything wrong.

Dr. Nikesh Seth, the only one of the doctors who returned a call seeking comment about the civil lawsuit filed Wednesday by Attorney General Mark Brnovich, acknowledged he did get money from Insys Therapeutics to speak about its drug Subsys. In fact, Seth told Capitol Media Services that he along with the other two doctors named in the lawsuit — Steve Fanto of the Phoenix area and Sheldon Gingerich of Tucson — were the only three in the state that were speakers for Insys.

The lawsuit separately charges the Chandler-based company with misleading patients and doctors about the dangers of the drug and of lying to insurers about the condition of the patients in a bid to get payment for the drug.

But Seth denied any link between the number of prescriptions he wrote for the sublingual version of the powerful opioid fentanyl and the money.

“They were educational programs that we were paid for where multiple providers across the country and in the Valley attended,” the Scottsdale pain management specialist said. “So they were actual legitimate speaker programs.”

That’s not the contention of Brnovich, who charges in the lawsuit filed in Maricopa County Superior Court that Insys “paid doctors sham ‘speaker fees’ in exchange for writing prescriptions, all in order to increase the sales of Subsys, without regard for the health and safety of patients.”

To back his contention, Brnovich said that in the two years before Seth began receiving speaker fees he wrote just 11 prescriptions for Subsys.

Then in the three months immediately before his first fee, he wrote 18 per month, a figure that increased to about 23 per month while Seth was actually getting paid an average of $207,000 a month. Yet in the seven months after the fees stopped, Brnovich said Seth was prescribing Subsys at a rate of two a month.

“The fact that we prescribed the product or that I prescribed the product is that it’s a very good product and we had an appropriate clientele of patients that got the medication,” Seth said. And Seth said most of those patients had “breakthrough cancer pain,” the only use for which the federal Food and Drug Administration approved the drug.

Seth acknowledged that he and the other doctors prescribed the drug to others experiencing pain, saying patients were warned about the dangers. And there is nothing illegal about “off-label” use.

Also named in the lawsuit along with Insys and Seth is Dr. Steve Fanto, who until July was in the practice of pain medication in Scottsdale.

His license was suspended after the Arizona Medical Board found he had improperly prescribed Subsys.

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Among the board’s findings was that he was starting patients off with 800 micrograms of Subsys, the highest available dose, despite FDA-required labeling that said they should be started at 100 micrograms with the dose slowly increased until there was an adequate pain-relieving effect with tolerable side effects. Brnovich said these prescriptions did more than put patients at risk.

“They also generated substantial revenue for Insys,” he said. “The higher the dose of Subsys, the more money Insys made.”

Also named in the lawsuit is Tucson pain management specialist Dr. Sheldon Gingerich.

The lawsuit said before Gingerich started getting speaker fees, he wrote fewer than one Subsys prescription a month. That increased to 10 a month in the three months before the fees started and 16 a month while he was getting paid a total of $83,100 in speaker fees and $7,200 in consulting fees.

Gingerich did not return phone calls for comment.

All totaled, Brnovich said, the three doctors were paid nearly $600,000.

But the attorney general said it was a good investment for Insys, with their additional prescriptions above their historic averages generating more than $25 million for the company.

But Brnovich’s harshest claims in the lawsuit were aimed at Insys — and not just for what the attorney general said was that “sham” speaker fees program.

He said the Chandler-based firm deceived insurers and pharmaceutical benefit companies into agreeing to pay for the expensive drug by misleading them to believe that the payment request was coming from a doctor’s office and not the company making the drug.

Brnovich also said those Insys employees misrepresented the medical conditions of the patients, lying that they had “breakthrough pain,” lying that the patients had tried other medications, and lying that the patients needed the sublingual spray rather than less expensive pills marketed by other firms because they had difficulty swallowing.

The lawsuit asks a judge to not only enjoin all the defendants from unfair, deceptive or misleading acts in the future but also seeks restitution to customers and an order that they surrender money they obtained “as a result of their illegal conduct.”

Insys did not respond to requests for comment.