According to allegations raised in a pharmaceutical whistleblower investigation, representatives of the drug maker InSys Therapeutics were told to tell insurers about fake oncology reports and patient codes, in order to get them to approve the use of Subsys among patients who never should have received the powerful fentanyl-based painkiller.
The revelations, published in an NBC news report last week, come from a former sales representative who claims that the manufacturer wanted to increase sales by almost any means necessary, including illegally.
The pharmaceutical company’s marketing practices have been under investigation since December 2013.
The Department of Health and Human Services Office of Inspector General (DHHS-OIG) began investigating Insys, the manufacturer of Subsys, for possible illegal off-label marketing of the drug, after it catapulted past the $100 million sales mark despite being introduced with limited approval for cancer patients suffering from severe pain.
Subsys is highly addictive and can pose life-threatening risks if patients overdose on fentanyl, which is a powerful opioid pain killer that is considered 100 times more powerful than heroine. Fentanyl painkillers are often used among patients suffering from chronic and severe pain, but it is also widely abused and overused.
The broad sales of Subsys raised suspicions, because the FDA approved the new drug in 2012, with recommendations that only oncologists and pain specialists prescribe the drug. Those prescribing doctors also had to undergo special training before being allowed to prescribe the drug and patients have to sign an agreement that they understand the risks involved as part of a Subsys Risk Evaluation and Mitigation Strategy (REMS).
Following a 270% increase in sales over just a year, it appeared that only 1% Subsys sales are by oncologists, about half are from pain specialists, and the rest of the prescriptions are issued by doctors, dentists and even podiatrists who appear to be using the drug off-label.
While doctors are permitted to prescribe any approved medication for whatever purposes they see fit, it is illegal for pharmaceutical companies to promote their drugs for applications that have not been approved by the FDA after establishing that it is safe and effective for that use.
Patty Nixon, one of the whistleblowers in the investigation, said her job was to contact insurance companies on behalf of doctors and patients to get them to pay for the drug, which cost between $3,000 and $30,000. She said sales representatives were told to do so by tricking the insurers into believing the drug was medically necessary.
Those tactics included telling the companies about oncology records that did not exist, and by referencing diagnosis codes that sometimes did not apply to the patient in question.
In response, InSys issued a statement about the report and allegations on June 4, saying that the story references actions by former employees, and that it does not believe Subsys is contributing in a meaningful way to the ongoing nationwide opioid epidemic.
Research published in 2015 concluded opioid overdose deaths have greatly increased, despite seeing a decrease in opioid abuse. Opioid overdose deaths have quadrupled since 1999, and a study published in April concluded the number of opioids deaths may be greatly underreported.
A CDC study published in March indicated patients face a six percent risk of abuse after filling an opioid prescription for a one day supply. That risk increases to 35% if the patient fills a prescription for a 30 day supply.
A recent study presented at the Society for Academic Emergency Medicine’s annual meeting indicated people treated in U.S. emergency rooms are often given narcotic painkillers for minor injuries, like sprained ankles. The risk also varied based on the part of the country the patient lived in, with patients from Mississippi receiving opioids more frequently for unnecessary minor injuries.
A study published in 2016 indicated opioid dependence insurance claims have surged by more than 3,000 percent in recent years. More than 1,000 people are treated in American ERs each day for misusing prescription opioids. The epidemic has even begun straining the nation’s intensive care units, doubling in-hospital deaths from opioid related admissions, taxing hospital staff and increasing healthcare costs.