By Andy Marso
The Kansas City Star
OVERLAND PARK, Kan. — A former patient of Overland Park pain doctor Steven Simon says that Simon and a nurse practitioner prescribed him high doses of an opioid spray from 2013 to 2015 even though the patient didn’t want it and it wasn’t approved for his condition.
Olathe resident James Whitham said he was being treated for gastrointestinal pain because of ulcers and a bacterial infection. But the drug he was being treated with, Subsys, a form of fentanyl sprayed under the tongue, is FDA-approved only for breakthrough pain in cancer patients who are already on long-acting opioid pain medications.
Simon has been under scrutiny for his prescribing practices and financial ties to the pharmaceutical industry, including Insys Therapeutics, the maker of Subsys.
Whitham said he had taken Subsys for more than a year when nurse Donna Ruck asked him if he’d be willing to say he had cancer.
“I said, ‘They’ve checked me from head to toe -- all these scans -- I don’t have cancer,’ ” Whitham said. “This is her exact words: ‘But would you feel comfortable telling me that you have at least precancerous cells?’ And I told her, ‘No, I don’t feel comfortable with that.’ ”
Ruck said via email that the conversation never happened.
“I categorically deny that I said that or would ever say that to a patient,” Ruck said. “His medical records show exactly the opposite of the claims being made. Mr. Whitham is incorrect in his assertion.”
Whitham stood by his account.
“I don’t know what would be in my records to contradict” it, Whitham said. “There’s nothing in my records that says I have cancer.”
Whitham said at one point, doctors suspected he might have cancer because of his family history. But no cancer was ever found, and by the time he went to Simon’s clinic, he had been diagnosed with ulcerative colitis and recurrent clostridium difficile, or “C. diff.”
Doctors are allowed to prescribe drugs for unapproved, or “off-label,” uses, but insurance companies often refuse to pay for those uses.
Six former Insys executives and managers were indicted on federal charges in December. The charges say the company used its speaker program to pay kickbacks to doctors for prescribing Subsys to people who didn’t have cancer, then worked with prescribers to defraud insurers by making it appear patients had cancer.
Those six have pleaded not guilty, but other Insys employees and physicians the company worked with have pleaded guilty to related charges.
The company’s latest quarterly report said it continues to receive subpoenas for information about doctors it worked with in other states, including one from the U.S. attorney’s office in Kansas.
Simon was the eighth-highest-paid Subsys speaker nationally from August 2013 to December 2015, according to a ProPublica database, and also trained other speakers for Insys. He was the top-paid Kansas doctor in the Subsys speaking program and the state’s top prescriber of the drug within the Medicare Part D program during those years. Simon declined to comment for this story, but in an interview last month for a previous story, he said he has not heard from any federal investigators about Subsys.
A speaker for at least a dozen pharmaceutical companies throughout his career, Simon said his experience with Insys was no different than that of any other drug company he worked with.
But the owner of the pain clinic, Dr. Srinivas Nalamachu, told The Star on Wednesday that agents with the FBI seized records last week related to patients for whom Simon prescribed oral fentanyl products, including Subsys.
Whitham said he has not been contacted by any federal agents.
Whitham also said Simon never told him that Arizona-based Insys was paying Simon about $220,000 in meals, speaking fees and travel expenses to promote Subsys to doctors and other prescribers.
Whitham first contacted The Star after an April article that detailed Simon’s speaking work for another drug, Movantik, which is used to treat opioid-induced constipation. The article mentioned that Simon was also paid to speak about several opioid-based medications, including Subsys.
Whitham said that made him rethink some of the interactions he had with Simon and his staff about the drug.
“He’s giving me a drug that he didn’t have to give me; he said it was in my best interest, but he’s making $200,000, or whatever it is,” Whitham said. “He’s making more money doing speaking engagements for that drug than I do trying to go back to work, and I can’t go back to work on that drug.”
Whitham, whose wife, Ashley, was at some of his office visits and corroborated his accounts of them, decided to go public after a follow-up article last month that detailed Simon’s full relationship with Insys and the federal investigation into the company. Whitham provided pharmacy records that showed Simon and others in his clinic writing him numerous Subsys refills throughout most of 2014 and 2015.
The visits
Whitham said he first started seeing Simon in 2013, when he was referred to the pain clinic after a hospitalization at Olathe Medical Center for pain caused by ulcers and recurrent C. diff.
At that time, he was on hydromorphone, a generic version of opioid-based pain pills commonly known by the brand name Dilaudid.
“I was fine on that,” Whitham said, adding that he still had pain but he could manage it.
Then began a period when Whitham was in and out of the University of Kansas Hospital and making visits to Simon’s clinic in between. Records provided by Whitham show that after Whitham was discharged from the hospital Oct. 28, 2013, Simon slightly decreased his hydromorphone but added a long-acting fentanyl patch.
Whitham said that was his first experience with fentanyl, a synthetic opioid that’s 50 to 100 times more potent than morphine. Hydromorphone is about 7.5 times more potent than morphine.
Whitham was discharged from KU again on Nov. 20, 2013, with instructions that he should “begin to taper opioids” because “continuing at current high amounts is likely not realistic as an outpatient.” Within two weeks, Simon had recommended that he go off the hydromorphone but start taking a second form of fentanyl: Subsys.
Whitham said Simon showed him how to spray Subsys under his tongue when his pain flared, but gave him no information about the risks of overdose or addiction or the symptoms of withdrawal. And Simon didn’t mention what the drug was approved for until Whitham’s wife asked him about it.
“He said something (like), ‘Well, it’s typically for cancer patients,’ ” Whitham said.
Records supplied by Whitham show that Ruck signed his first prescription. Whitham said it was a free sample that was filled without a problem, which itself raises questions. There are regulations at both the federal and state level that prohibit free samples of most controlled substances, including opioids.
When he went to fill his second prescription, the pharmacy had to bill insurance, and it did not go smoothly.
“We were there six, seven hours, trying to get this to go through,” Whitham said.
Whitham said he quickly concluded it wasn’t worth it. The Subsys had not quelled his stomach pain, and he was ready to go back to his previous regimen.
He called Simon’s office.
“And I’m screaming on the phone that I didn’t want to be on this,” Whitham said. “My point was, why are we doing this? We have a $5 hydromorphone, OK, or we have seven hours of paperwork.”
Whitham said he was passed off to an office nurse, and she was unyielding.
She said “that’s the drug that’s been given to you by the provider, and that’s it,” Whitham recalled.
Whitham faced more insurance issues later.
After losing his employer-based coverage through Aetna, Whitham said he planned to switch to his wife’s Blue Cross and Blue Shield of Kansas City plan. But that plan wouldn’t cover Subsys for him.
Whitham said that a Subsys drug sales rep was often in the pain clinic and weighed in when the problems with Blue KC cropped up.
Whitham said the drug rep, who works for Insys, joined clinic staff members in urging him to go back on Aetna through COBRA, which allows former employees to continue coverage temporarily if they pay the employer’s share of the premiums as well as the employee’s.
Whitham said he agreed to do it, even though it cost him more than joining his wife’s plan.
Insys declined to comment.
Whitham said Simon ultimately dropped him as a patient this year after he refused to go on Suboxone, an opioid addiction treatment drug. Whitham said that prescription would have branded him an addict and hurt his chances of going back to work.
“That will undermine everything I’ve ever done or will do in the future,” Whitham said.
Cancer conversation
Whitham’s records show that from December 2013 to May 2014, Ruck and Simon upped his Subsys regimen from 100 micrograms to 1,600 micrograms -- the maximum allowable and most expensive dose.
At one point, during another hospitalization, Whitham said he was working with KU providers to wean himself off the fentanyl and go back on the hydromorphone.
But when he went back to Simon’s clinic, he said Simon disagreed with the plan of care because it was causing withdrawal symptoms.
“What does he do immediately?” Whitham said. “Puts me back on 1,600 micrograms of Subsys. So I went from lowering myself off of everything, to where he said it’s in my best interest to go back to the 1,600 micrograms.”
Whitham said Simon’s enthusiasm for Subsys caused his wife to joke during one visit that it was as if Simon owned the company that made it.
Whitham said the joke seemed to irritate Simon. He said the doctor told him and his wife that, yes, he had stock in Insys, but that wasn’t why he was prescribing Subsys.
Whitham said Simon didn’t mention that he was also getting dozens of paid Subsys speaking gigs during that time.
But Whitham said it was clear that Simon was out of the office a lot. On those occasions, he would see Ruck instead. One time, Ruck was gone too, and Whitham said his prescriptions were just signed and waiting for him at the office when he arrived.
Whitham said that late in 2014, Simon transferred him to another doctor who worked at the clinic, Greg Buhler, but either Simon or Ruck still had to review and sign off on changes to his plan of care.
Whitham said he was seeing Buhler when Ruck pulled him out of the appointment -- and out of Buhler’s earshot -- to ask him the cancer question.
Whitham said the conversation bothered him enough that he remembered it clearly two years later. He said that when he returned to his appointment that day he told Buhler, “It’s almost like they want me to have cancer.”
Buhler, who no longer works at the clinic, did not respond to an emailed request for comment.
Whitham said Buhler told him at the time that Simon’s Subsys prescribing was under scrutiny, but would not say more.
By then, Insys’ marketing practices were also coming under scrutiny. A Nov. 27, 2014, article in The New York Times noted that several physicians being paid to participate in the Subsys speaker program had checkered professional histories.
In June 2015, The Times published a story about a Connecticut nurse pleading guilty to federal charges that the speaker’s fees Insys paid her were kickbacks in exchange for her prescribing Subsys, often to patients who did not have cancer.
Whitham said that he was taken off Subsys completely shortly after the conversation in the hallway with Ruck. His records show his last prescription for the medicine came Sept. 11, 2015, and he went from the highest dose to none at all, without tapering down. Whitham said he had mood swings he attributed to withdrawal.
“My kids called me ‘Mean Daddy,’ ” Whitham said. “My wife will tell you, they walked on pins and needles because I was in so much pain. ... I told Buhler it’s probably going to cost me a marriage if something doesn’t change, because I was not good to be with.”
He said Buhler did his best to help him.
Simon owned the clinic at the time when Whitham said he had the conversation with Ruck about cancer. When asked during last month’s interview about the conversation Whitham described, Simon said he had no knowledge of it.
“I was not in the room if a nurse practitioner did that,” Simon said. “I can tell you that if a nurse practitioner did that, I would like to know who it was because that person would have been fired immediately. That would have been an act that had no bearing on anything we had ever discussed and had no bearing on how the practice was to be run.
“We had four nurse practitioners who were helping see patients, but trust me, that is not something that ever happened that I was aware of.”
Nalamachu said he bought the clinic from Simon last year and kept Simon on as part of the terms of the sale.
When asked about Whitham’s story, Nalamachu said via email this week that he had “no knowledge of any of these events until now.” Nalamachu said Simon “will be leaving in the next few weeks as soon as he can find someone for his patients.”
Copyright 2017 The Kansas City Star