U.S. Attorney for the District of Massachusetts Carmen Ortiz is saying that executives from Insys Terapeutics, Inc. conspired to bribe medical staffs in multiple states to prescribe a certain pain medication.
The medication, "Subsys," is a sublingual spray intended to treat cancer patients experiencing intense moments of pain. The powerful narcotic is a highly addictive substance that can cause respiratory distress and death when taken in high doses or when combined with other substances.
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The indictment alleges the company paid doctors at a rate connected to the number of Subsys prescriptions written, masquerading as speaking fees. A doctor in Florida is said by federal prosecutors to have received $275,000 over three years from the company.
Arrests in this case go back to June, not long after Prince was found dead in his elevator, due to an accidental overdose of fentanyl. Fentanyl is a powerful pain medication that has a very specific use.
According to the Food and Drug Administration, Subsys has only one indication. It's meant for late-stage cancer patients with breakthrough pain, however, Insys has been accused of trying to push the drug far beyond cancer patients by convincing doctors to prescribe it for patients who have migraines or even minor neck or back pain.
According to physicians and experts, Subsys is about 100 times more powerful than morphine.
Why do companies do such things?
Subsys is the only brand-name drug Insys sells. In 2011, the year before it hit the marketplace, Insys was operating at a loss with no reported revenue. Last year, company revenues were $330 million; it reported a profit of $58.5 million. Lately, it has reported declining sales of the drug.
The company recently announced that its founder, John Kapoor, would be stepping down as chief executive.
During the growing opioid epidemic one of the biggest suspects in overdose cases is fentanyl.
On the day of their arrests, the Center for Disease Control and Prevention released a report showing that the rate of overdose deaths caused by synthetic opioids like fentanyl increased by close to 75 percent last year. The number of opioid deaths in the U.S. surpassed 30,000 for the first time in recorded history, rising above the number of gun homicides in 2015.
Founder and billionaire John Kapoor is what the rich call “innovative” and “a success story.”
"I look at doctors and we think, professionally they're all ethical and all that," Kapoor says. "I learned that in certain areas, like in pain management or in opioids--this is public information, I'm not making it up--that there are doctors that overprescribe and things like that." On speaker programs: "We have very strict company policies," Kapoor says. "If something happened in the field, sometimes the company may not know about it."
It's hard to believe that someone could run pharmaceutical companies for almost 40 years without realizing some doctors overprescribe medicines, particularly pain medicines. Kapoor--and Insys shareholders--would like to move the focus past Subsys, hoping sales, which have dropped in the wake of bad press and government investigations, stabilize. He would like the focus to be on other drugs. Insys just received FDA approval for a synthetic version of THC, the compound in marijuana, to treat nausea. It is developing a spray version of naloxone, the lifesaving antidote for opioid overdoses, and a synthetic version of cannabidiol, a component of marijuana that has shown promise in preventing seizures. Maybe after things with the Department of Justice are finally settled, that will be possible.
Amongst those arrested are the former Insys CEO Michael Babich.
The executives arrested include former Insys CEO Michael Babich of Scottsdale, Ariz.; the former national sales director, Richard Simon of Seal Beach, Calif.; the former vice president of sales, Alec Burlakoff of Charlotte, N.C.; and two former regional sales directors.