Baby getting medicine injected in her mouth. Stock photo of a baby receiving medicine from iStock/Getty Images.
No, this headline is not a joke, and no, two or three zeroes were not added as a mistake - which is not only absurd, but absolutely outrageous.
Synacthen Depot, a drug that is used to treat a rare form of epilepsy found in babies, has been hiked up by a shocking 2000% in Canada. In other words, the price of the drug has gone up from $33.05 a vial to $680 a vial.
At one of the world’s most renowned children’s hospitals - the Toronto Hospital for Sick Children - when a baby has infantile spasm, the staff treats it as an emergency. Says Sick Children’s neurologist Dr. Carter Snead: “This was just dropped like a bombshell.”
West Syndrome, also known as infantile spasms, is a devastating, catastrophic and rare form of epilepsy that some infants are diagnosed with after birth. What happens is that those infants have an unusual burst of electrical activity in the brain, which causes them to have spasm ‘clusters’ of several seizures in a row.
The infant requires immediate treatment once he or she has been diagnosed.
The price hike is a serious problem. In fact, the price is so high that Alberta delisted the drug in July of 2015 and may no longer pay for treatment. However, the drug could still be provided on a case-by-case basis.
Given the ridiculous price increase, it seems likely that other provinces could follow Alberta’s example, which will be a disaster for Canadian parents whose children develop infantile spasms.
How many parents can afford to pay $680 a vial to treat severe seizures in their baby?
The company responsible for the price hike in the drug, Mallinckrodt, claims it increased the price because of “a change of manufacturing.” Unless the drug is made out of gold and diamonds, one fails to see how a 2000% hike is justified.
Could Mallinckrodt possibly face a legal challenge over the ridiculous price hike of Synacthen Depot?
A recent court decision just came out of the Federal Court of Appeal, Canada (Attorney General) v. Sandoz Canada Inc. In the case, it was ruled that those drug companies that do not hold patents to drugs are subject to price regulations of the drugs they manufacture.
It’s a possibility, because not only is the price increase ridiculous, but the drug is also “long off patent.” So there may be a challenge soon coming to The Patented Medicine Prices Review Board. In 1987, the federal government established this tribunal to regulate drug companies that hold patents. Then in 2008, the board increased their jurisdiction to include generic drug producers as well.
Sandoz Canada Inc. and Teva Canada (which used to be Ratiopharm) challenged the board’s regulation over regulating generic drugs and lost, both at the Federal Court and the Federal Court of Appeal.
That means that generic drug manufacturers cannot just hike up generic drug prices at will. The price increase has to be reasonable.
For instance, in the above case, Ratiopharm had made a generic version of the Ventolin inhaler and sold it for $4.50, whereas the patent holder was selling it for $12.50. Then Ratiopharm decided to increase the price to $7.50, and the board was having none of it.
The board found the price hike “unreasonable” and fined the company $65 million for “excess revenue” to be paid to the federal treasury. Both the Federal Court and the Federal Court of Appeal upheld the board’s decision.
However, the court of appeal also criticized the lower court’s reasoning by saying they erred on the interpretation of government legislation. Says the court of appeal:
“Both the Federal Court judge and the Board agreed that the mischief targeted by these provisions was the excessive pricing of patented medicines…In losing sight of the ultimate goal of the provisions in question, he [the federal court judge] failed to appreciate that the mischief sought to be prevented could be caused without the patent owner itself charging excessive prices.”
The issue itself is excessive pricing of drugs, including patented ones, and the excessive greed of pharmaceutical companies. That is what the regulations should aim to curb according to the court of appeal.
A prime example of what should not be allowed is the ridiculous price hike for Synacthen Depot, which is to be hoped will be challenged very soon - before sick infants will fail to get the treatment they desperately need.