The price of drug prescribed to infants in Canada with a rare and potentially dangerous form of epilepsy has jumped by 2,000 per cent practically overnight, upsetting specialists and parents.
Infantile spasms, also called West syndrome, is a catastrophic and rare form of epilepsy. It's diagnosed in babies with seizures that show abnormal bursts in the brain's electrical activity on an electroencephalogram or EEG.
Mia Brooks of Salmon Arm, B.C., noticed the seizures in her son more than a month ago.
"When he woke up he started to startle reflex," Brooks recalled. "You see babies do this all the time. Their hands and legs shake. I thought it was odd because he was doing it repetitively every 10 seconds or so and he did it for a couple of minutes."
At Toronto's Hospital for Sick Children, infantile spasm is treated as an emergency, said neurologist Dr. Carter Snead. Rapid treatment is critical. He's angry about the price increase.
"This was just dropped like a bombshell," Snead said about the way the price increase was communicated to provinces and hospitals.
The treatment protocol starts with one drug. But about half don't respond to it. So doctors then turn to Synacthen Depot, a long-acting form of the drug that is injected into muscle. The drug is long off patent. Snead said it works 90 per cent of the time.
"The price of Synacthen Depot increased by more than 2,000 per cent from $33.05 per vial to $680 per vial," said Carolyn Ziegler, a spokeswoman for Alberta Health.
The price was so high that Alberta delisted it in July, Ziegler said, meaning it's no longer automatically paid for by the province. The drug may still be provided on a case-by-case basis
Health officials in British Columbia, Saskatchewan, and Ontario reported similar increases.
"They just bought it and jacked up the price," Snead said.
Mia Brooks calls the price increase "absurd." She's worried that she will eventually be asked to pay for some of that increase.
"There's no way we can access that amount of money," she said.
The global pharmaceutical company Mallinckrodt owns the rights to Synacthen Depot in Canada. Mallinckrodt says it increased the price because of a change of manufacturing. The company did not respond to requests for details about where it manufacturers the drug and why the change in manufacturing justifies the price increase.
"When Mallinckrodt acquired Questcor in 2014, Synacthen Depot was one of the products in the portfolio. It was losing money then and still is. Moreover, in the spring of 2014, Mallinckrodt was told by the existing supplier of the product that they would cease production in early 2016," a Mallinckrodt spokesman said in an email to CBC News.
Health Canada said it knows where the drug is made but says it considers the information proprietary.
Mike Bartenhagen of Omaha, Neb., joined an infantile spasm support group after his son, Broc, was diagnosed in 2002.
Bartenhagen disputes the company's reason for increasing the drug's price.
"My opinion is that Questcor and Mallinckrodt's opinion on this is 'Hey, good news, we are not screwing you [parents]. We are screwing somebody else,'" such as insurance companies and public health plans.
Snead thinks governments should demand their money back, saying he's dismayed at the thought of children not getting treated.
"If the seizures aren't treated, the child will not regain any milestones," such as being able to roll over, Snead said. The seizures can evolve into other kinds of epilepsy, which are not controllable by medication.
Brief history of Synacthen Depot
Synacthen Depot, or tetracosactide, is a synthetic version of a hormone secreted by the pituitary gland.
Novartis sold the international rights for Synacthen Depot to Questcor on June 11, 2013, the same day former hedge fund manager Martin Shkreli's former company, Retrophin, was about to sign a deal for the rights, according to documents from the U.S. Securities and Exchange Commission and anti-trust court filings.