Danielle and Jonathan Foltz live on the New England coast with their three children. In an CNN article, Wayne Drash documents their meteoric fall from a mission family with big plans of helping others in Africa into an American cage match, fighting not only a chronic disease but one of the biggest pharmaceutical companies too.
The Foltz’s youngest son Trevor was diagnosed with a rare form of epilepsy called infantile spasms, or West Syndrome. For more information on West Syndrome, click here.
Trevor’s doctor prescribed him with a drug called Acthar. Unfortunately for the Foltz’s, while the drug was priced at $1,600 at their son’s birth, by the time of his diagnosis 7 months later, the price had jumped to $23,000 a vial.
It took days as the Foltze’s struggled to make a deal with their insurance company. Eventually the grand total of $125,000 was covered in full, but it was going to take even more time for the drug to be physically available to the family.
Trevor’s brain was still in development and uncontrolled seizures would leave his brain function permanently damaged. Of the 2,000 babies diagnosed with infantile spasms each year, 70% to 90% will have intellectual and developmental disabilities. Fast treatment is critical, yet the family’s insurance company held up the shipment of the drug due to its extreme cost. Phone call after phone call finally resulted in the guarantee of a verified delivery to the Foltz’s in three business days.
“When your infant’s body is being racked by 40 seizures every single day, you do not have three business days to play Russian roulette, waiting for a medication that could stop his seizures and right your world again,” Danielle said.
But in the end, all their efforts seemed to be validated. Trevor’s tremors stopped for a time. A little more than a year later, however, the seizures returned. Another round of treatment was in order, along with another $125,000 payment.
The question of how a drug could climb from $40 a vial in 2000 to $39,000 in 2018 may come to the average readers mind. Despite federal investigations and protests from top medical associations, the makers of Acthar, Questcor and Mallinckrodt seem unstoppable.
The companies were not responsible for the development of the drug, an isolation made in 1933 by the same biochemist who helped to discover insulin, but purchased the rights in 2000. Upon doing so, prices for Acthar immediately increased, with an historically exponential jump in 2007 from $1600 to $23,000. During this time a synthetic form of Acthar was developed and began to breach the market at a much cheaper price. This company was quickly purchased and thwarted by Mallinckrodt so as to restabilize their monopoly.
Access to Acthar kept becoming further and further out of the realistic reach of patients living with chronic seizures. Doctors expressed frustration at not being able to help patients to the best of their ability due to the hesitance of prescribing such enormous debt as well. Hospitals were asking why the drug was so expensive. Pharmacists were asking what Mallinckrodt was doing to make it less so. All of these questions were eventually legally addressed to Mallinckrodt by a 20-member congressional panel, of which Danielle Foltz was a part.
In response to the grievances presented before it in court, Mallinckrodt said that the drug’s
“previous owner was near bankruptcy upon the time of their acquiring the drug and raised the price of the drug substantially”
…to keep it on the market. Questcor’s claim was that to preserve the existence of Acthar, it had to be cultivated into a business model that would prove economically sustainable.
With this in consideration, Drash makes a point to note that
“Mallinckrodt was reporting net sales from Acthar of $1 billion.”
The congressional trial resulted in a $100 million settlement between Mallinckrodt and the government.