This story involves a rarely-prescribed, dangerous medication, a practice known as “off-label” prescribing – and a conscientious individual who was dismissed from her employment because she expressed her ethical concerns.
Danita Erickson began working with Biogen in 2011. During her seven years with the company, she consistently received positive reviews – right up until just before her termination. The immediate cause of her termination was an attempt by a colleague to get credit for the sale of a very expensive drug called Zinbryta (daclizumab), a prescription medication that, until last year, was used to treat patients suffering from “relapsing” multiple sclerosis.
This drug was deemed extremely dangerous by both the FDA and the European Medicines Agency, having been linked to liver failure, inflammatory diseases of the brain, and serious skin rashes. Biogen and partner AbbVie have since voluntarily pulled Zinbryta off the market. It was still available in September 2017, however.
Daclizumab was first approved in 1997 as an anti-reject medication for kidney transplant patients and administered in combination with corticosteroids (anti-inflammatories) and ciclosporins (immuno-suppressants). At an estimated cost of nearly $1400 per dose, the drug maker anticipated sales of up to a quarter-billion dollars within five years.
In September 2004, PDL BioPharma, the company that held the patent at the time, began studying the drug for the treatment of respiratory disease. The following year BioGen joined forces with PDL in order to find additional indications for daclizumab. In 2016, the FDA finally approved the medication in May 2016, for multiple sclerosis patients on the condition that post-marketing studies be carried out and a Risk Evaluation and Mitigation Strategy be submitted. It has also been studied for the treatment of a certain form of retinal inflammation.
It has never been approved for aplastic anemia, a condition in which the body stops producing red blood cells. However, when Erickson’s fellow worker discovered that a hematologist in Olympia, Washington was writing an off-label prescription for that very purpose, he entered false diagnostic codes on a company form in order to take credit so as to earn a commission and bonus.
When Erickson attempted to report her concerns to her supervisors, they did nothing to address the problem. Instead, they encouraged it. She then went over their heads and filed a complaint with the company’s corporate integrity department. Her immediate supervisor learned of the report and began taking a series of retaliatory actions, culminating in her termination in March of last year.
Erickson filed a lawsuit in July 2018, claiming “unlawful retaliation in violation of the False Claims Act.”