There was one piece of news that probably didn’t make many of your feeds this morning that is very important in my industry: today is the day the patent on Lipitor expires.
I’m sure most of you are saying, “Huh?” or “So what?” or perhaps “Maybe now my prescription will cost less…”, but I look at it as the end of an era of one of the most important drugs in the last 20 years. First synthesized in the mid-1980s, it was approved by the FDA in at the end of 1996 (how’s that for a product development cycle?). Lipitor (like other statins) inhibits HMG-CoA reductase, which catalyzes the rate-limiting step in cholesterol synthesis in your liver. Turns out, that’s a good thing.
So much of a good thing that the promise of Lipitor sales has prompted three mega-pharmaceutical mergers, the most recent being Pfizer’s acquisition of Warner-Lambert about 10 years ago. And for good reason. During its patent life, Lipitor sold about $130 billion worth of product. That’s a lot of pills. I suppose it’s also a lot of pizza and cheeseburgers.
With the onrush of new generics (look for atorvastatin), certainly its place as the best-selling pharmaceutical in the world will be displaced despite what I’m sure will be a huge effort by Pfizer to keep the number scrips up. And while that’s probably good for the consumer, from a product standpoint it’s sort of a shame, because Lipitor rocks.
In this business, there’s an inside joke that a medicine only needs to be two things: effective and safe. Lipitor is both. The drug not only decreases cholesterol and lipid concentrations, but more importantly in long term trials has been shown to decrease the number and severity of cardiovascular events (heart attacks and strokes), while maintaining an excellent safety profile. In fact, an 11-year study published in The Lancet this week showed that treatment with statins had cardioprotective properties for five years after people stopped taking it. Better yet – there were no red flags in terms of long-term safety.
As someone that’s worked in the drug industry for close to 20 years and has heard all the bad news, billion-dollar failures, and toxicity stories, it’s important to remind myself that sometimes we get it right. And in case like Lipitor, sometimes we get it really right. Maybe it takes an insider– someone who has seen the sausage getting made — to appreciate it, but Lipitor is to pharmaceuticals what a Beethoven symphony is to classical music, or the Chrysler Building is to architecture. It’s not perfect – nothing is – but it’s about as good as you’re likely find.