Thursday, December 1, 2011

Lipitor Goes Generic, and Everyone Wins...Theoretically

I like to play a game with my med students, residents, and fellows--although really the game can only be played with residents and fellows as the students don't have enough medical mileage under their belts to fare well. I ask them this question: what do they think are the five greatest drugs of all time? After all, people routinely debate the greatest baseball player--I'm partial to Willie Mays--the greatest writer in the English language, the greatest movie, and the list goes on. Why not have a discussion about what makes a drug great?

So we talk about how drugs are used and what makes them good or not. I do this exercise to get them thinking about qualities that define particular drugs or entire classes of them, and why some may be preferable to others. Such qualities include "applicability" (i.e. how many people would benefit from its use, as Tysabri is an incredible drug that preserves quality of life, but only does so for people with advanced multiple sclerosis, a very small group), the magnitude of benefit (a drug that saves a life is more important than one that eases wrinkles, such as Botox™), ease of use, minimal side effects, and a proven track record (drugs that are new to the market often appear miraculous; most don't last, as the brief life of Xigris shows) among other things.

Lively debates ensue, but what I find most interesting is that the drugs that most housestaff end up agreeing on are ones that have been around a very long time and weren't developed by recent pharmaceutical company R&D programs. And by "recent" I mean the past 30 to 40 years. Aspirin may be the greatest drug of all, and has been around in its current form since the mid-19th century (and the active ingredient was found in folk remedies long before that); morphine and its narcotic siblings are likewise more than a century old; penicillin-class and sulfa antibiotics were developed before World War II; insulin was first used in the 1920's after decades of research; and beta-blockers were first developed in the 1960's.

That said, one class--relative teenagers compared to these elders--stands out, and one drug from that class stands out in particular.

The class of drugs are known as "statins", and the drug is Lipitor, the signature product of Pfizer. Since its introduction in 1996, Lipitor has not only gone on to become a blockbuster drug--its total estimated gross is $100 billion--but has by any measure been proven to meet the definition of a wonder drug. It is reasonably safe, most people tolerate it, lots of people require it, and it saves lives. Lots of lives. It's usefulness has been proven over and over again in well-designed trials. Unlike so many other drugs, its initial promise has not begun to fade.

The biochemical pathway in which Lipitor and its fellow statins work disrupts cholesterol synthesis, but we're still learning about how it works its magic: other medications that lower cholesterol in different ways, such as ezetimibe (trade name of Zetia™), seem not to have the same benefit in terms of preventing heart attacks and death that the statins do. Moreover, while Lipitor wasn't the first statin to market, and there are six other members of the statin class, Lipitor has reigned supreme. This is due in part to a more profound reduction in "bad cholesterol" LDL and an elevation in "good cholesterol" HDL than others in the class, but also its "gentleness", as for instance rosuvastatin, whose trade name is Crestor™, lowers the LDL the most of any in the class, but does at the cost of more serious and more frequent side effects. (A useful consumer review on statins from Consumer Reports can be found here.)

Pfizer has seen an enormous windfall from Lipitor, and they have deserved every penny. It is, in other words, an "honest" drug: no ridiculous shenanigans, such as those seen in the marketing of the generally unimpressive drug Neurontin by the very same Pfizer corporation, or the introduction of the current #1 drug by sale, Nexium, which is nothing more than a clever repackaging of Prilosec, whose patent was due to expire and would have deprived its maker Aztra Zeneca of billions of dollars. But today Lipitor is now open to the competition, as its patent expired on Wednesday, so generic atorvastatin can be made and marketed in the US, which should drop the price of atorvastatin considerably. Thus, although I make no claims to be an economist or an intellectual property law expert, it looks like the expiration on the patent of the greatest modern medical drug was a win-win for both consumers and the shareholders who brought the drug to market.

I say "looks like" only because Pfizer, as this article explains, still intends to protect Lipitor's brand name in some ways that defeat the entire purpose of the spirit of patent law. Some of their efforts, like direct mailings of "coupons" for lower copays for Lipitor, seem free-market legit. Others, however, have that unpleasant odor so frequently associated with Big Pharma these days. In particular, Pfizer appears to be cutting deals with so-called "Prescription Benefit Managers" to elbow out the competition. PBMs serve as third-party payers for insurance companies and administer drug formularies. Pfizer's goal in negotiating with the PBMs is to give Lipitor at a discounted price in exchange for the PBM not carrying other companies' generic atorvastatin, effectively cutting them out of large markets.

It is not an illegal practice, although I fail to understand how this benefits consumers tremendously. Nor does the CEO of Watson Pharmaceuticals, Paul Bisaro, who complained about Pfizer's tactics on CNBC's "Squawkbox"--not exactly the kind of haven for socialist ideologues. But the story is still in motion, the deals are taking place in the backrooms and boardrooms away from journalists, so time will have to tell about atorvastatin's future. Today, however, was a good day for medicine, for business, and ultimately, for patients.

PS--we also note with great enthusiasm that Gary Schweitzer's Health News Review blog has adopted a new look. Go check out the makeover! It is among the most valuable resources on medicine, and comes awfully cheap.

1 comment:

  1. Just wonderful - thank you! - and very relevant. I've recently started on the generic for Zocor (Simvastatin), as the bad cholesterol gene finally found me... despite the diet, exercise and all the tennis. As an aside, they don't call the industry Big Pharma for nothing, so not surprised in the least re: Pfizer.