Is That An Experiment Or Are You Just Glad To See Me?

From time to time I’ll encounter a story in the regular media that makes me wonder if the reported behind the article is trolling me, or is being trolled himself. For those unfamiliar with the term, trolls are fun-loving denizens of the Internet who enjoy getting an extreme reaction out of people who should know better. Going onto a discussion board or the discussion section of a website and making comments that you know will move the regular readers into a bowel-clenching outrage is called trolling those individuals, and it has become so common in some parts of the Web that it’s generally best to assume that any wild tale, tall story or outrageous claim is being made expressly for the purpose of making you make a fool out of yourself by reacting to it – especially if the comments run exactly opposite of the belief systems associated with the site you’re on. In this particular case, however, I can’t imagine who would make up a story about a drug company raising the price of a medication by 7,500% - or who would find the resulting outrage amusing, for that matter…

According to a story that appeared on the Los Angeles Times website on March 9th, the K-V Pharmaceutical Co. of St. Louis has just gotten FDA approval to sell a drug called Makena, which dramatically reduces the probability of premature birth. Up until now this treatment hasn’t be commercially available; you had to get a compounding pharmacy to make it for you out of the raw materials, which cost about $20 per (weekly) dose. Of course, without standardized production under FDA-certified facilities there was always a certain amount of variance in the exact formulation (and effectiveness) of the product, and there is no real debate that the officially approved version will be safer and more reliable. That said, however, the increase in price from around $20 to $1,500 per week (or $700 to $54,000 if you prefer) still seems a little steep…

Even worse, in my opinion, is that a lot of health insurance plans won’t cover Makena, which means that the drug will have gone from a manageable expense to something that only the very wealthy and very fortunate can get. But the part that makes this story sound like a prank is that K-V Pharmaceutical is exerting legal pressure on the compounding pharmacies that used to make the stuff from scratch, threatening to sue them for patent infringement if they don’t stop making the drug. Given that the company stands to make a small fortune off of a product that they didn’t have to invent (only synthesize in the lab), couldn’t they just let the people who are poor enough (or desperate enough) to use a home-brewed equivalent of the name-brand drug go about their business and turn a blind eye?

Well, if you’ve been paying attention to our discussions of copyright and patent infringement, you already know that they can’t. If K-V doesn’t defend the patent against all comers, there’s nothing to keep another giant corporation from pirating the formula and charging even more for it. And, in fairness, the company did have to go through all of the usual clinical trials, get all of the required permits and approvals from the FDA, and invest all of the money necessary to get this product through the testing process and onto the shelf. Comparing the official version of the drug, properly certified and made using approved processes to the home-made version is like comparing packaged analgesics to willow-bark tea (which DOES have analgesic properties, but isn’t the most reliable remedy in the world). There’s no real question that the K-V product will be safer to use and more effective, or that the company has complied with every legal and regulatory requirement. It’s just that imposing this pricing structure in a year when the future of health-care management is one of the biggest news stories – and one of the most contentious political issues – is so tone-deaf it makes me wonder if someone is trolling us – or conducting some kind of social-science experiment…

Either way, I really wish they’d stop…