Patent Expires On Best Selling Drug of All Time 491
Hugh Pickens writes "The U.S. patent has just expired on Lipitor, the best-selling drug of all time, as the first generic versions go on sale, marking the end of a brand that has dominated the drug industry, lowered the cholesterol of tens of millions of patients, and generated $10.7 billion last year in annual sales. But drug manufacturer Pfizer, dependent on Lipitor for almost one-fifth of the company's revenue, does not intend to go down without a fight. Pfizer is employing unprecedented tactics to hold onto as many Lipitor prescriptions as it can with an aggressive marketing plan and forging deals with insurers, pharmacy benefit managers and patients to meet or beat the price of its generic replacements because even at the lower price, Pfizer has a huge profit margin because of the relatively low cost of materials for Lipitor. Some deals require pharmacies to reject prescriptions for low-cost generics and substitute a discounted name-brand Lipitor while other deals block generic makers from mail-order services that account for an estimated 40 percent of all Lipitor prescriptions. 'Pfizer's tactic of dressing up as a generics company is pulling the rug under the incentive system created to foster the development of generic drugs,' says attorney David A. Balto."
Choosing the correct tactics (Score:3, Interesting)
At least Pfizer isn't trying to unreasonably extend the patent, sue its customers, or use other underhanded tricks to cheat the system at the expense of everyone else.
Unlike some other...companies.
Patent vs Copyright (Score:5, Interesting)
So, if congress has been able to withstand the lobbying for indefinite patents, given the massive amount of money on the line as indicated by this single drug patent, how come they fold to the likes of Disney when it comes to copyright? Maybe it's the cuteness of the cartoon characters.
Re:See. Patents/Copyright spur innovation. (Score:5, Interesting)
Re:Patent vs Copyright (Score:5, Interesting)
It's simple.... insurance companies have more lobbyists than pharmaceuticals. And insurance companies like generic drugs, because it lowers their costs, and increases profit of the insurance co..
Re:Choosing the correct tactics (Score:5, Interesting)
I'm unclear here. Since when did pharmacists suddenly get the right to override a doctor's prescription? How can Pfizer actually get a pharmacist to sign an exclusivity agreement.
Re:In other news (Score:4, Interesting)
More likely they will "invest research capital" into the "vastly superior" "lipitor HCl" or similar.
This is a comon practice in the pharmacutical industry. Create a game changing drug, then milk it *FOREVER*, by tacking on a medically useless functional group to change the molecule enough to file for a new patent, covering the entire chemical family.
Re:See. Patents/Copyright spur innovation. (Score:4, Interesting)
Re:See. Patents/Copyright spur innovation. (Score:4, Interesting)
Re:Choosing the correct tactics (Score:4, Interesting)
I on the other hand seem to be very unlucky with about 20% of generics I get. Many times they're fine, but one in particular is terrible. I'd been prescribed Xanax for severe anxiety attacks, and the generic form actually makes me sick and nauseated to the point the anxiety seemed to be the better option. Originally they covered it but later implemented a generic-only policy. I had to fight my insurance company tooth to nail to get them to cover Xanax, which they did, after an absurd amount of time.
In general I think it's not the worst policy in the world, but don't get them wrong -- insurance companies only do it to save them money, not you.
Example of a publicly developed vaccine (Score:4, Interesting)
I suggest you pay more attention before writing "bears only the most tenuous connection to the truth" then following that with something that is incorrect.
Re:See. Patents/Copyright spur innovation. (Score:5, Interesting)
Necessity is the mother of invention, not avarice.
Re:Great, more incentive for doctors to overprescr (Score:4, Interesting)
No, part of me wonders the same thing. There has been research published recently that suggests that the link between serum cholesterol and cardiovascular disease may not be as direct as once thought. If the thing that we're measuring does not have a direct correlation to future disease, then the drug we're taking to lower the measurement might not have any real benefit. Statins like Lipitor have probably improved the health of a lot of people, but they may still be overprescribed.
I mean, TFA itself says Lipitor is "the best-selling drug of all time." Really? Would that many people really have died of heart attacks had they not been prescribed this drug?
People talk about how "modern diet, modern society is killing us" -- again, really? You should have seen how my grandfather ate. He'd trim the thick ribbons of fat from the ends of his pork chops so he could eat them last, then he'd eat the fat off everybody else's plate. He lived to a reasonable age, long before statins were ever invented. Sure, that's anecdotal, but where are the statistics? Was heart disease caused by high cholesterol really that much more common among my grandfather's generation? Or my father's? So much more common that it proves that almost everybody ought to be on Lipitor? My gut tells me no. Some studies from England [nih.gov] (where my grandfather lived) suggest rates of heart disease did increase through the postwar years, but then started to decline in the 1970s -- again, before statins were even available. One does have to wonder.
Re:See. Patents/Copyright spur innovation. (Score:4, Interesting)
Exactly. A good rule of thumb: if your "right" requires others to do something for you, it's not a right - it's a service.
Re:See. Patents/Copyright spur innovation. (Score:5, Interesting)
Re:See. Patents/Copyright spur innovation. (Score:5, Interesting)
They may also outcompete on patient satisfaction.
Generics don't necessarily equate (nor do branded versions), and both for that reason and physician inertia, the prescription market tends to be slow to shift. Here's an example:
http://www.citizen.org/Page.aspx?pid=3106 [citizen.org]
As to why they don't equate -- even when the active ingredient is identical, the various binders and excipients can greatly differ, and that can mean that some patients only do well on a specific brand. This can be particularly critical with drugs that are prescribed in very low doses (micrograms) or that tend to degrade very rapidly.
I was just reading a study on that the other day (can't find it again offhand but it was in NEJM) -- for one commonly-prescribed drug, results were radically different depending on the binder -- from 18% to 90%. This can result in nominally-identical drugs not being bioequivalent (and the FDA has a rating system for bioequivalence).
[BTW as it turned out, the cheap old-fashioned sugar-based binders performed best.]
Re:See. Patents/Copyright spur innovation. (Score:4, Interesting)
the pharmaceutical industry is one of the few areas left in the US consistently providing high paying jobs to smart, motivated and educated people.
I generally agree with your stance, but lines like this bother me. My sister used to work for a number of pharmaceutical companies. "High paying" doesn't really describe the positions very well, and the instant a breakthrough was made, management sold the company and the workers got their pink slips (hence, working for "a number of" companies). I find it amazing that anything gets done at all, when everyone knows an R&D breakthrough means everyone loses their job.
It's as dirty a business as any other.
Re:See. Patents/Copyright spur innovation. (Score:5, Interesting)
This is utter nonsense. Anyone with a decent understanding of scientific method and the ability to read research papers is fully qualified to make judgements about the drugs they should take. It boggles my mind that people will go in to their mechanic and question whether a proposed treatment is the right one but will give over care of the only body they ever get to someone else.
I do have conversations with doctors over treatments. I ask why they recommend a particular treatment, what alternatives exist, etc, and I research them. Interestingly, sometimes doctors don't know why one treatment is better, it's just what they like to do. Rarely, some have given me answers that amount to folk medicine. "My mom always..." The ones who really impress me say things like "Yes, drug X is getting a lot of press, but clinical trials show it's not more effective than the one I recommend, which also has fewer side effects/costs less/whatever". Those are the doctors I want.
You are actually a great case in point. I trust if/when you go to a doctor who prescribes Nexium for you, you will demand generic Prilosec because you know it's a better choice for you.