The case of Dr. Jeffrey Goldstein, an Upper East Side doctor who was sentenced to 57 months in federal prison last week in connection with a kickback scheme involving fentanyl, draws back the curtain on a different form of fentanyl abuse.
Goldstein was prescribing Subsys, a potent fentanyl-based spray, in exchange for bribes and kickbacks from Subsys’s manufacturer, according to the United States Attorney’s Office for the Southern District of New York.
As opioid addiction has worsened during the COVID-19 epidemic, and overdose rates skyrocketed across the United States, illicitly manufactured fentanyl and other synthetic opioids have often been seen as the primary drivers. But that is not the only source of abuse.
Subsys, which is manufactured by Insys, is a powerful painkiller approximately 50 to 100 times more potent than morphine.
The Food and Drug Administration approved Subsys only for the management of breakthrough pain in cancer patients. But additional profits lay elsewhere.
In 2012, Insys launched a “Speakers Bureau,” a roster of doctors who would conduct programs supposedly aimed at educating other practitioners about Subsys.
“In reality, Insys used its Speakers Bureau to induce the doctors who served as speakers to prescribe large volumes of Subsys by paying them Speaker Program fees,” said the U.S. Attorney’s Office.
Speakers were supposed to conduct an educational slide presentation for other health care practitioners at each Speaker Program. In reality, many of the Speaker Programs were predominantly “social affairs where no educational presentation about Subsys occurred,” according to the charging documents.
The nearly $200,000 in kickbacks for Dr. Goldstein, a 50-year-old osteopath with a practice in Manhattan and who lives in New Rochelle, located in Westchester County, north of New York City, included an all-expenses-paid visit to a strip club courtesy of the drug manufacturer, reported Patch.
Prescriptions of Subsys can typically cost thousands of dollars each month. Medicare and Medicaid, as well as commercial insurers, reimbursed prescriptions written by Dr. Goldstein.
“He put his own patients at risk in order to satisfy his own greed, and will now spend time in federal prison for recklessly prescribing this highly addictive and powerful opioid.” said Audrey Strauss, the U.S. Attorney for the Southern District, in an announcement about the sentence.
Dr. Goldstein received approximately $196,000 in Speaker Program fees from Insys in exchange for prescribing large volumes of Subsys. After the doctor began prescribing a competitor painkiller, Insys pressured him to stop doing so and switch patients back to Subsys, which Dr. Goldstein did, according to the U.S. Attorney’s office.
When Insys employees took Dr. Goldstein and a medical colleague to a Manhattan strip club, Insys spent approximately $4,100 on a private room, alcoholic drinks and lap dances for the two doctors.
Dr. Goldstein also arranged for Insys to pay for the annual holiday party for his private medical office.
In 2014, he was approximately the fifth-highest-paid Insys Speaker nationally. He was the sixth-highest prescriber of Subsys in the last quarter of 2014, accounting for approximately $809,275 in overall net sales of Subsys in that quarter.
In 2018, five doctors, including Goldstein, were arrested and accused of receiving bribes and kickbacks from the pharmaceutical company in exchange for prescribing millions of dollars’ worth of the potent fentanyl-based spray.
Dr. Goldstein was the last of the five to be sentenced.
Insys paid the doctors, in some cases more than $100,000 annually, in return for prescribing millions of dollars’ worth of the company’s painkiller product, reported The New York Times.
Two former Pharma Company-1 employees, Jonathan Roper and Fernando Serrano, had also pleaded guilty in connection with their participation in the bribery and kickback scheme. Both cooperated with the government.
The pharmaceutical company behind the scheme was also brought down.
Last January, the founder of Insys Therapeutics, John Kapoor, of Phoenix, was sentenced to 66 months in prison, three years of supervised release, and ordered to pay forfeiture and restitution.
According to the Department of Justice, “As a veteran of the pharmaceutical industry, Kapoor learned that he could profit from developing a spray delivery system for a generic drug, then marketing it as a premium product.”
Kapoor privately funded Insys as it developed Subsys, which was eventually approved to treat cancer patients suffering intense breakthrough pain.”
Kapoor hired, or authorized the hiring of, several top executives who became co-conspirators in the criminal scheme to bribe practitioners, many of whom operated pain clinics, to prescribe Subsys to patients, often when medically unnecessary
“A substance as powerful as fentanyl should be prescribed based only on doctors’ own independent medical judgment,” said then FBI Assistant Director-in-Charge William F. Sweeney Jr. when announcing the indictment of Dr. Goldstein.
“In this case, as alleged, a series of doctors were convinced to push aside their ethical obligations and prescribe a drug for profit to patients who turned to them for help,” said Sweeney.
Fentanyl can be deadly if it is prescribed in large doses to someone who has not already become tolerant to opioids, “yet the drug has been widely sold to a variety of patients,” reported The New York Times.
An analysis for The New York Times by the research firm Symphony Health, for example, found that just 1 percent of prescriptions for Subsys were from oncologists.
Doctors across the country have been accused of over-prescribing opioids.
One of the most egregious cases was of a Virginia doctor, Dr. Joel Smithers, who prescribed half a million opioid and fentanyl pills in two years, and was sentenced to 40 years in federal prison. He was convicted of causing the death of one of his patients.
According to the DEA, pharmaceutical fentanyl was developed for pain management treatment of cancer patients and originally applied in a patch on the skin.
However, because of its powerful opioid properties, illicit fentanyl, manufactured in Mexico or China, was increasingly added to heroin to increase its potency or disguised as highly potent heroin, said the DEA.
“Many users believe that they are purchasing heroin and actually don’t know that they are purchasing fentanyl – which often results in overdose deaths,” said the DEA.
The NIH says, “The misuse of and addiction to opioids—including prescription pain relievers, heroin, and synthetic opioids such as fentanyl—is a serious national crisis that affects public health as well as social and economic welfare.”
The Centers for Disease Control and Prevention estimates that the total “economic burden” of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.