It appears that are no limits to which Insys Therapeutics won’t go in order to boost its opioid profits. Last week, the state of Arizona and health care provider Anthem filed a consumer fraud lawsuit against the Chandler-based pharmaceutical company over its powerful specialty opioid painkiller, Subsys®.
According to the complaint, Insys provided false information about the drug’s FDA approval status in order to convince doctors to write off-label prescriptions. Incredibly, the company claimed that Subsys had FDA approval for uses that in fact had not been granted. Insys went further, however. The state of Arizona alleges that Insys bribed physicians, passing these payments off as “speaker fees” for doing “educational presentations” at medical conventions and other events.
As it turns out, that “investment” may have paid off very well. Between March 2012 and April 2017, revenues from Subsys totaled approximately $52 million – and more than two-thirds of those prescriptions were written by three physicians. Each of them, who have been named in the lawsuit, wrote about 1,000 prescriptions for Insys over the five-year period in question.
That is not the end of Insys’ legal problems. On Wednesday, U.S. Senator Claire McCaskill (D-MO) released findings from an ongoing Congressional investigation of the company. It turns out that Insys has been engaging in fraud and bribery for years. One of those schemes literally involved creating non-existent cancer patients in order to convince insurers to cover the drug.
According to the report, Insys used a mixture of pressure and financial incentives in order to get its employees to contact insurance companies, having them pretend to be calling from doctors’ offices in order to get “prior approval” for Subsys. They also provided false medical records for prospective Subsys patients, “fraudulently asserting that a patient had a cancer diagnosis, regardless of the patient’s history and regardless of whether the prescriber had prescribed Subsys for a different diagnosis.”
In order to understand why Insys engaged in this behavior, it is important to know more about Subsys and how the for-profit health care system works. Subsys is an extremely powerful, fentanyl-based opioid. It is used for cancer patients with debilitating pain whose bodies do not respond to other pain relievers.
The drug received FDA approval in 2012, but Insys Therapeutics soon found there weren’t enough cancer patients to make the drug profitable. On top of that, the drug is extremely expensive, and insurers typically will not cover the costs of such drugs without “prior approval.” In the case of Subsys, insurers were only willing to cover the costs for actual cancer patients suffering from “breakthrough” pain – in other words, pain that “breaks through” other medications, rendering them ineffective.
When there weren’t enough actual cancer patients to take the drug, Insys embarked on an elaborate scheme to convince insurers otherwise. The Congressional report states that in addition to pressuring employees to participate in the fraud, the company blocked its outgoing phone numbers on caller IDs in order to prevent those calls from being traced back to Insys’ offices.
They also set up a toll-free number when insurance companies required contact information, answered by Insys employees claiming to be from doctors’ offices. Those employees would then act as if they were examining patient records, giving the insurers fraudulent information, suggesting that a patient was suffering from “breakthrough cancer pain” – without actually mentioning the word “cancer.”
The charade has cost the life of at least one patient, who was prescribed Subsys, yet did not have cancer. The New Jersey woman died of a Subsys overdose last year.
Insys Therapeutics is rapidly becoming the new “poster child” for everything that is wrong about America’s corrupt, for profit health care “system.” Pharmaceutical companies like Insys will stop at nothing to increase their profits. And, because of the nature of the American health care system, many primary care physicians are employed by – and therefore beholden to – a large, profit-driven corporation.
Many of them also carry hundreds of thousands of dollars in medical school debts. As a result, there is no shortage of doctors who are willing to pad their own paychecks by accepting “speaker fees” and other bribes in order promote a new drug for almost any indication, approved or not, regardless of its safety or efficacy.