A Palm Beach County physician — one of the nation’s top prescribers of a highly addictive fentanyl spray — believes he is one of 10 unidentified doctors described in a federal criminal indictment against executives of a pharmaceutical company prosecutors say bribed doctors to prescribe the drug.
The indictment lists the 10 as “co-conspirator practitioners,” but Dr. Bart Gatz said he did not conspire with Insys Therapeutics to commit any crime, and his “life is hell” after he got entangled with the company. Gatz has not been charged with any crime or sued in connection with his prescribing of the spray, called Subsys.
A Greenacres pain specialist and anesthesiologist, Gatz told The Palm Beach Post that he has been unfairly lumped in with other physicians who abused a promotional speakers program by the Arizona-based company that federal prosecutors call a “sham.”
“I never conspired to break the law. All I did was treat my patients. I didn’t do anything wrong,” Gatz said. “My side is not out there.”
Gatz is one of the top prescribers of Subsys and one of Insys’ top speakers in the country, according to data from the Centers for Medicare and Medicaid Services. He earned $229,000 between August 2013 through 2015 from the speaker program — the seventh-highest in the nation. The indictment alleges that the company paid physicians as “speakers” only to fuel more prescribing at higher and higher dosages.
“It was my go-to medication for cancer patients for a while before Subsys had its legal issues,” said Gatz, who operates Comprehensive Pain of the Palm Beaches and says he has staff privileges at four county hospitals. “It just felt it wasn’t going in the right direction.”
One red flag for Gatz: His Insys sales rep’s former job was as a Publix cashier, and she was uninformed about the highly addictive and potentially deadly product.
Insys is being sued by families over deaths of their loved ones. Others are suing, saying they unwittingly became addicted, not knowing they were taking fentanyl.
Gatz generated more than $4.1 million in payments to Insys from Medicare alone, according to government data.
The federal criminal indictment out of Massachusetts charges seven Insys executives, including founder John Kapoor and former CEO Michael Babich, with racketeering and conspiracy. Among those charged is former national sales chief Alec Burlakoff, whom Gatz has known for more than a decade.
Burlakoff, who hails from Boca Raton, is portrayed as the chief driver behind the speaker program at the center of the federal indictment to get doctors to prescribe Subsys for routine pain, such as migraines.
Gatz’s license with the Florida Department of Health is listed as clear and active with no disciplinary action against him. He said his speaking engagements for Insys were legitimate, with detailed slide shows and attended by other doctors. He said he prescribed Subsys for breakthrough cancer pain.
The indictment lists two Florida doctors in the list of 10. Gatz said the description of Practitioner No. 4, the money he earned through the speaking program and other details lead him to believe it is him.
The indictment describes the doctors as “co-conspirators” who engaged with the Insys defendants “in various criminal activities” and whose identities were shared with the grand jury.
Gatz’s attorney, Robert Winess, takes great issue with that description, saying that not all the doctors share the same culpability and that describing his client as such is not only inaccurate but defamatory.
When it comes to Practitioner No. 4, prosecutors are particularly focused on the doctor’s relationship with Burlakoff.
Burlakoff, on his very first day on the job at Insys, the indictment states, targeted Practitioner No. 4, telling a sales rep that the doctor “was first and foremost a businessman” and should be used in the speaker program “as a way to pay Practitioner No. 4 for writing fentanyl spray prescriptions.”
What is fentanyl?
A synthetic painkiller 50 times more potent than heroin, fentanyl is a chief reason the opioid epidemic is killing so many people. The street version is mixed with or substituted for heroin. Fentanyl killed the singer/songwriter Prince.Whether it’s in prescription form or made in a clandestine Chinese lab, a tiny dose the size of a grain of salt can be lethal. First responders have been warned about encountering even small amounts. Carfentanil, an analog of fentanyl normally used to sedate elephants, is another killer in the opioid crisis.
Practitioner No. 4 was invited to Insys’ Phoenix headquarters in January 2013 in hopes executives could persuade him to write more prescriptions, according to the indictment. Burlakoff and another executive took the doctor to a nightclub.
The next day, Burlakoff sent a text to a sales rep, saying that he and the doctor had stayed out until 4 a.m. and that “he had to have had one of the best nights of his life.”
The next week, Practitioner No. 4 wrote 17 Subsys prescriptions, the indictment stated.
The document says this same doctor made $260,000 in speakers fees from August 2012 to November 2015.
Gatz described Burlakoff as a personal friend, a hard worker, a good salesperson and likable. But Gatz also said he felt betrayed by Burlakoff when Burlakoff bragged at a sales conference about his relationship with Gatz. The physician said he flew to Arizona twice to meet with Burlakoff but said the “night of his life” comment was just the executive “trying to sell his friends on how cool he is.”
The pain specialist also said he was unaware that his name is in a 2004 whistleblower complaint filed against Burlakoff’s former employer, Cephalon. The complaint alleged that the company used a speaker program as a way to promote a fentanyl lollipop, Actiq, to be prescribed for pain other than cancer, such as migraines.
“If I knew all that, I wouldn’t have dealt with Burlakoff after that,” Gatz said.
In the suit, Gatz is named as a physician who was targeted to increase these off-label prescriptions. Records show Gatz was paid nearly $135,000 from Cephalon between 2009 and 2013 for consulting, speaking, travel and meals, according to data compiled by ProPublica.
The federal government used that suit to pursue action against Cephalon, which ended up paying $425 million in civil and criminal fines in 2008 for marketing the product for off-label purposes.
Gatz has had his problems with Medicare, as well. His former clinic paid $1.1 million to settle allegations that doctors there had charged federal health-care programs for unnecessary nerve tests.
He entered into a three-year integrity agreement with the U.S. Department of Health and Human Services in April 2016.
The agreement imposed obligations ranging from independent review of his books to posting a sign in his office for a hotline to report suspected fraud. He could lose approval to participate in federal health-care programs if he fails to follow the agreement.
Gatz said he has adhered perfectly to his integrity agreement and that it stems from incomplete, not unnecessary, tests.
He denied the allegations in the whistleblower lawsuit that led to the HHS investigation filed by an employee in the billing department of his former clinic — Florida Pain Medicine Associates. The suit alleged that “a great many patients” were addicted to painkillers and were forced to consent to nerve damage tests or back braces to receive their pain meds.
Gatz was accused of billing for 75 patients a day, “a running joke in the office,” the suit says, because “there was no way Dr. Gatz could physically perform 75 real visits per day.”
Gatz said the federal government never made any findings on the allegations by his former employee. Gatz disbanded the clinic afterward and opened up his current business on Jog Road.
How doctors ended up entangled with Insys is spelled out not only in the criminal indictment but in civil suits and legal action taken by states to recoup Medicaid money.
The company used a target list containing the names of “coachable” physicians who prescribed a lot of narcotics and who they thought would be open to off-label prescribing, court documents state.
Oncologists — doctors who treat cancer — were “lower-level targets,” according to one of a bevy of lawsuits filed against Insys.
“Make sure you choose the correct horse. … Ride your horses every chance you get,” the indictment quotes Burlakoff as saying about doctors to his sales staff. He sent a photo of a horse to them, saying, “If you want to win, it is time to start cracking the whip!”
The problem for Burlakoff and his sales team, prosecutors say, was that the U.S. Food and Drug Administration approved the highly addictive Subsys only for breakthrough cancer pain — a limited customer pool, according to court documents.
Insys instead illegally marketed Subsys for off-label ailments, such as migraines or routine back pain, according to numerous court actions brought by states across the country.
Insys sales reps even targeted physicians known to run pill mills, court documents state.
The company put the reps in doctors’ offices. It ran a large phone room dedicated to getting authorizations for payments from insurance companies.
It was a profitable business plan. Between 2013 and 2015, Insys netted about $650 million in revenues. Its business plan was also illegal, federal prosecutors say.
Gatz said that up to 70 percent of his patients who received Subsys suffered from cancer pain.
Doctors can prescribe medicines off-label as they see fit. Pharmaceutical companies, though, are barred from marketing their products for any use that is not FDA-approved. Gatz said he prescribed Subsys off-label only to patients after they had life-threatening or spinal surgeries.
He said he found Subsys, which is sprayed under the tongue, a perfect medication for cancer patients who had trouble swallowing because of chemotherapy and for patients who couldn’t go home because they had to get painkillers through an IV at the hospital.
“The problem with Subsys isn’t that it is not a great product. The problem is that the founder of the company was a criminal,” Gatz said.
Nearly 50 doctors nationwide got paid more than $100,000 each from Insys, according to Medicare data. Most of the money came from the speaker program. Doctors also got paid for meals and travel.
Already, doctors are serving prison time. Drs. Xiulu Ruan and Patrick Couch, of Alabama, are serving 21- and 20-year sentences in federal prison after being convicted of running two huge pill mills and taking kickbacks from Insys. Together, they were paid more than $270,000 by Insys, mostly for speaker fees, from August 2013 through 2015.
Michigan’s Dr. Gavin Awerbuch, who plowed $9.3 million into his collection of baseball cards, ancient coins and stamps, was sentenced to 32 months in February for health care fraud and distribution of controlled substances. He received nearly $90,000 in speaker fees from Insys.
In March, Rhode Island Dr. Jerrold Rosenberg was sentenced to more than four years in prison. He was paid $168,000 by Insys from August 2013 through 2015.
“You in effect sold your medical license to a pharmaceutical company,” U.S. District Judge John J. McConnell Jr. told Rosenberg. “That’s intolerable.”
And more doctors recently have been charged. Five physicians in New York were charged in March with crimes related to taking payments for prescribing the fentanyl spray.
The indictment states how doctors were not only paid hundreds of thousands of dollars through a sham speaking program but also treated to strip club outings, fancy dinners and, in one case, a $9,800 security system that was never installed.
A doctor’s girlfriend also was hired to be his Insys sales rep.
Insys went into business with physicians already under indictment or investigation.
Insys paid more than $86,000 to Chicago’s Dr. Paul C. Madison. Before Insys came along, Madison was under federal indictment for health care fraud. Trial is set for November. Illinois regulators in November 2016 suspended the doctor’s license, alleging he ran a cash-only pill mill, accusing him of prescribing huge amounts of fentanyl and other painkillers. He set up shop in Indiana.
Dr. Judson Somerville in Laredo, Texas, got paid $67,000 while he was under investigation by the state medical board for pre-signing prescriptions for controlled substances. After three of his patients died from overdoses in 2012, he lost his ability to prescribe oral painkillers. Last summer, he lost his medical license because he ran unlicensed pain clinics and “continued to prescribe very high doses of opioids in an escalating fashion.”
All of this feeding at Insys’ trough violated the oath these doctors took, said Christopher Porrino, New Jersey’s attorney general, who has sued the company under the False Claims Act. In October, Porrino moved to revoke the license of pain specialist Dr. Kenneth Sun.
“The more drugs Dr. Sun prescribed, the more money he appeared to have made,” Porrino said in a statement.
“This kind of profit-based drug dispensing is what you’d expect from a street-corner dealer, not a trusted health care provider, and it will not be tolerated in New Jersey.”
Sun was paid as much as $12,000 a month from Insys for speaker events and, according to ProPublica’s “Dollars for Docs,” netted more than $115,000 from August 2013 through 2015. He agreed to a temporary suspension in December 2016.
“We contend that Dr. Sun and Insys were working together to make money in the cruelest and sickest way possible, by pushing a dangerous and addictive opioid painkiller on patients who didn’t need it and weren’t approved to receive it,” Porrino said.
Gatz informs would-be patients on healthgrades.com that he is a family man, born and raised in Omaha, Nebraska, and “was taught values that are unparalleled to others.” He says he is “always putting my patients FIRST!!”
A patient posting to the Facebook page for Gatz’s previous clinic gushes about him: “I thank God for Dr. Gatz and what he has done for me.”
But now Gatz says he feels under siege and so do his patients, who worry about the future of their care.
“It’s crushing,” he said.
PAY TO PRESCRIBE? THE FENTANYL SCANDAL