Pharmaceutical companies are supposed to make medicines accessible for all. Granted, they have to make a profit, but that profit shouldn't come at the expense of people's lives, as was the case with Mallinckrodt Pharmaceuticals. This week, the company settled a lawsuit with the U.S. Federal Trade Commission (FTC) for $100 million. Mallinckrodt supposedly engaged in illegal anti-competitive behavior to maintain its monopoly on an infant medication for epilepsy.
The drug in question is meant to treat infantile epilepsy, specifically a rare form of it called infantile spasms. Usually, this condition manifests before the first birthday of babies that have cerebral palsy, Down syndrome, tuberous sclerosis, or other such health problems. It affects only an estimated 2,000 to 2,500 children a year in the U.S. — quite a small market for a specialized drug.
Acthar Gel, a hormone injection used to treat infantile spasms, was acquired by Mallinckrodt when it bought Questor Pharmaceuticals in 2014. Before Questor bought the drug in 2001, it sold for $40 a vial. In 2012, under Questor, the price was raised to $28,000 a vial. After Mallinckrodt acquired the drug from Questor, the price went up even higher to $34,000 per vial. This inflated pricing generated more than $1 billion in revenue for Mallinckrodt in 2015.
In order to maximize their profits from this specialized drug, Mallinckrodt snuffed out its only competition, Synacthen, a drug long used outside of the U.S. to treat infantile spasms. After buying the rights to Synacthen, Mallinckrodt locked the drug away, ensuring a monopoly on drug treatment for this rare condition.
Despite the lawsuit settlement, Mallinckrodt still claims no wrongdoing, arguing that because Acthar Gel and Synacthen are two drugs that work differently to treat the same condition, developing the latter would be difficult. "The company argued in its statement that the resources necessary to develop Synacthen in the U.S. would be considerable and pointed out that trials could be difficult to conduct because patients would have to forego a known treatment, Acthar," according to Carolyn Y. Johnson of The Washington Post.
Patients Should Come First
The Mallinckrodt case was brought to light by pharmaceuticals entrepreneur Martin Shkreli, who himself is a known price gouger. Shkreli name-dropped Mallinckrodt and Questor to the FTC in 2014 when his own company, Retrophin, filed a suit against the other two pharmaceutical manufacturers for anticompetitive tactics. But don't be mistaken about which side Shkreli is on, the patient's or the bottom line's — he jacked up the price of anti-parasitic drug Daraprim overnight by 5,000 percent. Clearly, the drug isn't that complicated to produce as high school students in Australia managed to make it themselves.
This kind of behavior is terrible for society. Medicines should be accessible to those who are in need of them, but all too often pharmaceutical companies forget the "pharma" side of their business and just focus on being for-profit undertakings. Of course, income is important — some of it can be put back into research to develop even better drugs — but the patients who depend on medications like Acthar Gel are far more valuable. Healthcare shouldn't focus on patents or income. It should focus on patients.
To a great extent, situations like these explain why many treatments for various diseases don't make it to market. To be sure, research and clinical tests do take significant time, but sometimes these drugs don't even get to clinical tests. If pharmaceutical companies aren't willing to carry a drug — because it wouldn't be profitable to do so — we have a problem. Things have to change, and systems have to be improved. Perhaps placing more thorough regulations on the pharmaceutical industry is the answer. Maybe something else is. In any case, changes need to be made to ensure everyone who needs a life-saving medication has access to it.