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."
See. Patents/Copyright spur innovation. (Score:5, Insightful)
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
Yes, they do. Being able to get sole rightrs on the drug is why tneya re invented. It can cost mollions of dollars.
And this article is much ado about nothing. Patent is expiring, company ups advertising and lowers price.
BFD
Re:See. Patents/Copyright spur innovation. (Score:5, Interesting)
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
It's not a patent problem it's an anti-trust problem. Please adjust your 'fixit' suggestions accordingly.
Re:See. Patents/Copyright spur innovation. (Score:5, Informative)
Drugs come from... drug companies, not from universities, because drug companies have the billions of dollars to put a compound through clinical trials and the expertise to make the drugs usable.
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
You don't need patents to commercialize medicine. With the exception of clinical trials, everything could be done in a free market just as well (and did; aspirin was invented in Germany but couldn't be patented there; in fact in the early part of the 20th century, before Germany and France allowed drug and chemical patents, they were the center of innovation in those fields.)
Clinical trials are like a public good, and all things told society would maximize its wealth by ditching patents and funding clinical trials with taxes. A very good read on the myths of copyright and patents is "Against Intellectual Monopoly".
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
Monopoly drugs are what's expensive. If you remove one of the justifications for absurd monopoly prices on drugs, you will likely save much more money in the long run than you spend on drug trials.
Besides drug trials represent an obvious conflict of interest if being carried out by a company that stands to profit greatly from the ensuing monopoly. Taking them completely out of the hands of the drug companies might not be a bad idea just for that.
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
The clinical trials have to adhere to extremely strict regulations by the FDA.
Also, there is insane liability with drugs too. If you (by your suggestion) think that drug companies are at all interested in cutting some corners during testing and trials, you're clearly not considering the amount of money said company stands to lose if something bad were to happen. If you want to see a sample: http://drugclassactionlawsuit.com/ [drugclassa...awsuit.com]
So, yea, there's huge risk in bringing something to market. I don't know what a good solution is yet, or if maybe moving the research/testing to the public sector is a good idea... But don't discount that the drug companies (the few that are still around) have plenty riding on making sure those trials.
Re:See. Patents/Copyright spur innovation. (Score:5, Informative)
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
Drugs come from... drug companies, not from universities, because drug companies have the billions of dollars to put a compound through clinical trials and the expertise to make the drugs usable.
And don't forget, they've got twice as much money for advertising those drugs as they have for researching those drugs and running those clinical trials. [sciencedaily.com]
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
Drugs come from... drug companies, not from universities, because drug companies have the billions of dollars to put a compound through clinical trials and the expertise to make the drugs usable.
And don't forget, they've got twice as much money for advertising those drugs as they have for researching those drugs and running those clinical trials. [sciencedaily.com]
Actually, I sold my Pfizer stock long ago, because in an era where medicine's costs are skyrocketing, share value remained pretty much flat. Or dropped.
After a while I noticed that the REAL drug development seemed to come out of small companies. Big Pharma (Pfizer and friends) were more interested in buying them out than in actual productive work of their own.
Liptor is the Drug From Hell as far as drug companies are concerned. Every attempt to replace it with something with a newer patent has exploded in their faces, as all the Lipitor "improvements" have been pretty darned dangerous, whereas Lipitor is fairly safe for most people.
Re:See. Patents/Copyright spur innovation. (Score:5, Interesting)
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
thank you.
lets always remember that if they can afford so much on advertising and marketing, SOMETHING IS WRONG and should be changed.
this is healthcare. its not some luxury item.
lets not forget this. its what makes us HUMAN, dammit.
healthcare is different. it is. if you don't understand that, you are a barbarian.
Re:See. Patents/Copyright spur innovation. (Score:4, Insightful)
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
Not really. Everybody acts like sales and marketing are unimportant details. They are not. Products do not sell themselves, and no amount of disliking sales and marketing people is going to change that. Companies that ditch their highly-paid sales staff (some of whom will outearn the CEO/founder, especially in small companies) quickly find this out.
This response is completely upside-down: taking a serious problem that "free market fundamentalists" have created in the U.S., and treating it as if it is not only normal, but also inevitable and really a GOOD thing!
The fact that the U.S. dropped restrictions on drug companies on marketing prescription drugs directly to the public, thus becoming the only country in the world that allows it, is part of the reason that the cost of medicine in the U.S. has exploded.
The enormous ad expenditures are for direct marketing to the public. Except for the very safe drugs for commonplace ailments that are sold OTC public is not qualified to make judgments about the drugs they should take. Honest. They aren't. Doctors are paid to have that expertise. We don't need direct marketing to the public. No other nation needs it. Big Pharma didn't use to need it. But doctors they aren't immune to the pressure from their patients - nor are they completely immune to the absolutely fact-free, emotion-laden content of ads which they also see constantly (there used to be much stronger restrictions also on how Big Pharma could seek to debase the judgment of doctors directly - through perks that are just dressed-up kick-backs for prescribing costly drugs). None of this is necessary to practice good medicine - it undermines it in fact.
A classic recent example of how the marketing game is the drug Prilosec -- pushed incessantly by its patent holder until the day the patent expired. The next day no comment of this worthy drug could be found, now it was a new patented replacement virtually identical in effects called Nexium. Trying to push the now inexpensive generic Prilosec out of the public's (and doctor's) mind and replacing it with the needlessly costly Nexium did no benefit to the public or medicine. It was an ad campaign solely designed to keep medical costs high.
Yeah. We need lots more of that.
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.
Re:See. Patents/Copyright spur innovation. (Score:4, Informative)
You do realize that with your second sentence you've just reduced your "public" to about 5% of the population?
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:Example of a publicly developed vaccine (Score:5, Informative)
I don't have the slightest clue as to why you're modded at +5, but I do know that you have literally no clue as to what in the hell you're talking about. I assume you're referring to the anti HPV vaccine Cevarix rather than Gardasil because you mention "the Australian taxpayer" and some of the technology used in Cevarix was discovered at Uni. Queensland. You conveniently neglect to mention that the Queensland researchers were collaborating with others at Georgetown, the Uni. of Rochester and the US National Cancer Institute, among others. The technology behind the discoveries made at these places was licensed to GlaxoSmithKline, a British company. The idea that the Australian taxpayer footed the bill for the FDA trials in the US is, frankly, idiotic. The trials were conducted by Glaxo, obviously. Additionally, there is no "US drug company that licenced [sic] it", it's being sold by Glaxo here just as it is everywhere else.
I know it's a crying shame that none of this fits into your wacky worldview where all corporations represent the nexus of evil and steal all their product ideas from "the people", but I guess you'll just have to find some way to get over it. I suggest you take some of your own advice about "paying more attention before writing" before your next post.
Re:Example of a publicly developed vaccine (Score:4, Insightful)
Universities don't discover drugs. They discover mechanisms. Drug companies make drugs that work on those mechanisms. I suppose, if the Aussie taxpayers really did finance all of Gardasil, they ought to be intelligent enough to extract some pretty damned good fees for the US patent rights. If they can charge much more, but don't pay more, then what kind of chumps are running AU? Sure as hell not the CSIRO guys who went after Buffalo.
Probably the kind that care more about saving lives and recouping their costs than n figure profits.
Re:See. Patents/Copyright spur innovation. (Score:5, Informative)
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
We should be cutting the middle-man and funding those projects more
I think you need both systems. Academia is just as attractive to hucksters as the free market when flush with money. How many BS grant proposals get written just to finance the existence of a department? The university system is one of the crowning achievements of humanity, but let's not get carried away and think it can replace capitalism.
Comment removed (Score:4, Insightful)
Re:See. Patents/Copyright spur innovation. (Score:4, Interesting)
Re:See. Patents/Copyright spur innovation. (Score:4, Insightful)
You don't need to, because that's a strawman. Proponents of patents/copyrights hold that those things get us more innovation than we would without them, not that there would be none at all without them.
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Re:See. Patents/Copyright spur innovation. (Score:5, Interesting)
Necessity is the mother of invention, not avarice.
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The only difference is that competition will drive down prices and drive up quality.
It'll go to whoever can make it the cheapest and still turn a profit, which will be whoever has the biggest manufacturing operations, because the person who actually invents it has nothing of value, to create any kind of profit from it they would need a manufacturing operation, one capable of competing with existing established large manufacturing operations. How are they going to do that?
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I just don't buy that we'll stop innovating if patents and copyrights disappear. There will still be profit to be made and there will still be incentive to make that profit.
The problem here (and I am against many patents/copyrights for the most part) is that due to the "We must be 100% certain that no-one will be hurt in any way, shape, form or other..." approach taken by most countries in what they allow to be used for treating what - and the absurd litigation that occurs throughout the US when unforseen side-effects surface, or medications don't work quite as advertised. These things have driven up the cost to go from an idea or even some solid research to the point where it
Comment removed (Score:5, Funny)
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
That's a nice Hollywood-inspired vision you have there.
Reality is that research costs money. A lot of money. Being passionate and driven, in the Hollywood sense, is largely irrelevant because that does not get you research dollars. Money for health-related research comes from the NIH, and only the NIH, to first approximation. Yes, there are other sources, but the NIH dwarfs them all. Sure, an extraordinarily motivated researcher might be able to convince George Soros to give him a few million dollars to pursue a multi-year plan on a new drug target, but that's the Hollywood fantasy again. The vast majority of biology researchers get their money from the standard NIH grant mechanism called an R01 (pronounced ARR-OH-ONE). That would be your tax dollars at work.
As another poster pointed out, that's only the first step. A drug target has been identified by university research. Now, the hard part begins where multiple animal models are tested in large scale, followed by Phase I clinical trials with a small cohort to demonstrate that the drug causes no harm, then Phase II trials with a slightly larger cohort to determine effective doses, then, perhaps, another animal study or two because the results didn't work as well as anticipated in humans, followed by Phase I again on a reformulated drug, then more research to figure out why there were horrible side-effects, back to Phase I, then Phase II, and, if the developer is lucky, Phase III. We're talking years after the initial discovery now, with lots of hospital costs, lots of salaries, and *then* the legal stuff starts with the FDA to get approval for general release. Next, lobbying starts on the insurance companies, especially Medicare and Medicaid, to cover treatment with the drug.
Put it this way, there is an entire industry focused specifically on clinical trials, and most drug candidates don't make it through. Because we've set the bar so high to get a drug approved, and the success rate is so low, there must be substantial reward for many people to justify the expense. One researcher having a dream is not enough, despite what Hollywood would have you believe.
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Yes, they do. Being able to get sole rightrs on the drug is why tneya re invented. It can cost mollions of dollars.*
They did get $10.7 billion in revenues last year. For the most part I'm ok with them making a lot more than the drug costs to develop. After all not every drug is successful. I'm pretty okay with the time for patents. I might argue a little shorter but its a low item for my ideal(ological) patent system. I think the only problem I have is the influence marketing has on people. Not that advertising your products is bad but that many people use it as their sole source of research.
I believe there is a
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If you remove profit, then nobody will look for new and better drugs. That, and today's profits off of drugs like this are funding research into next generation drugs and treatments, testing and trials and lawsuits and .... What you're really asking for is for no more research. That's pretty despicable.
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
If Pfizer still has a big profit margin after the patent has expired, why wouldn't they have invented anyway?
Because the costs of manufacturing a drug once it has been created and approved are much less than the costs of developing one. They will still have a good profit margin TODAY because the costs of designing and testing the hundreds of potential candidates they went through to get to a final, working drug were paid off during the patent period.
They wouldn't have a profit margin if they had to sell the drug from day one at the same price as those people who are going to manufacture the generics now.
Developing drugs is a risk. You can get all the way to trials and then find out that your fancy new LDL drug gives 50% of the people who take it the hives or only works in 3% of the users. All the money you spent getting there is gone. People who fund that kind of risk deserve to get paid back for taking the risk, mostly because they won't take the risk unless they do.
Re:See. Patents/Copyright spur innovation. (Score:4, Insightful)
They may very well have. Obviously we can't know what happens in that alternate reality. But there are a number of reasons why they might not:
1) They could wait for someone else to do the work, produce the drug, and make even bigger profits by saving the development costs.
2) They don't know ahead of time that the drug will be so successful, and not having the exclusive period increases the risk.
3) "Profit" at this point is a marginal concept. Producing more Lipitor and selling it cheap is profitable. That doesn't imply that selling it cheap this whole time would have been profitable when considering the development costs.
4) The article notes that Pfizer may be able to out-compete generic producers based on cost. I have no data to back this up, but it's possible that expertise or industrial scale gained during the exclusive period plays a role in their comparative efficiency.
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: (Score:3)
thats EVIL.
The amazing thing is, despite icky shit like this, capitalism STILL has out-competed every other economic system devised by man. Maybe technology will let us move to a more sane system for matching supply to demand. We already monkey around with capitalism, because while it is pretty good at meeting demand, it seems to be terrible at factoring in external costs or contingencies. So we do things like screw with the market so we have a planned glut of food, and screw with the market by having emissions tradin
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
I'll give you an example. A coal power plant sets up shop on the east coast of the US. It has no pollution controls at all, because this is pure capitalism in this example and the government doesn't require any. Prevailing winds are westerly, so all the pollution blows out to sea and no one gets sick and no one sues. Problem is, all that mercury is getting into the fish. It's impossible for anyone to prove this to a jury and sue that particular plant, so it just continues. Even if they could prove that, statistically, the plant was responsible for some of the mercury - they still would have a heck of a time proving harm. Capitalism will never solve this problem.
Another is food. Capitalism always has cycles of shortages and gluts. A shortage of hard drives because of a flood in Thailand is one thing, a shortage of food is quite another. Capitalism will never solve this problem, because constantly producing a glut of food would drive farmers out of business which of course leads to a shortage. One solution is for the government to come in and buy the glut and then destroy it - unless of course there is no glut! Then you get to use the food and thank the usually wasteful food program. Not the only solution, but it's a common one. The point is, capitalism won't work on it's own when it comes to staple foods.
Re:See. Patents/Copyright spur innovation. (Score:4, Insightful)
Re:See. Patents/Copyright spur innovation. (Score:5, Informative)
If they want to outbid generics on price, nothing's wrong with that. But those agreements mentioned in TFS, where pharmacies must only prescribe their offering - that sounds rather anti-competitive to me.
Re:See. Patents/Copyright spur innovation. (Score:5, Informative)
- Pennsylvania [state.pa.us], for instance.
I'll just add... (Score:4, Informative)
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
Patents by design grant a TEMPORARY monopoly to cover the cost of R&D and to provide incentive for companies to actually do the R& D in the first place.
The problem with the drug industry is that in order to comply with the regulatory quagmire that is the FDA, they have to disclose essential details about their work publicly long before it can go to market. Hence patents must be acquired long before the drug can make any money. These days drugs cost literally billions of dollars to develop. Burning patent life during the R&D time robs the companies of profits they would have earned, driving up costs for the consumer as they must raise prices in order to recoup R&D expenses in the shortened time the product is on the market under patent. Remember, these drugs save lives and directly improve the quality of life for potentially billions of people. These same people will eventually get reduced cost access to the drug when it goes generic off patent.
Contrast this with the entertainment industry: Anyone can pen an idiotic ditty for virtually nothing, in basically no time at all. The product merely provides people with fleeting, momentary amusement. No lives are saved, no diseases cured. Even the biggest, most expensive blockbuster movie costs a fraction of what it cost to bring lipitor to market..
Now unless you're an idiotic, dirty, lazy hippie who thinks everything should be free, you will have to admit that unless people are going to get paid, there is no way they are going to spend all that time and effort on drug development even if the end result means lives are saved. After all they have mouths to feed, mortgages to pay, etc, and the pharmaceutical industry is one of the few areas left in the US consistently providing high paying jobs to smart, motivated and educated people.
Turns out the profit motive is a terrific way to get people to do useful things. Who'da thunk that people were willing to work so hard in order to get ahead. Amazing, isn't it?
Re:See. Patents/Copyright spur innovation. (Score:4, Interesting)
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
Key word being try. We don't have to let them. And we certainly shouldn't overreact by abolishing IP entirely.
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> Now unless you're an idiotic, dirty, lazy hippie who thinks everything should be free, you will have to admit that unless people are going to get paid, there is no way they are going to spend all that time and effort on drug development even if the end result means lives are saved.
I was going to mod you down as troll/flamebait since you seem to be an ignorant greedy capitalist but that wouldn't encourage people to actually discuss and raise above this ignorance. Namely,
a) you are generalizing and maki
Re:See. Patents/Copyright spur innovation. (Score:5, Insightful)
First, kudos for keeping the discussion civil.
I disagree with some of your points, though. Specifically:
You _do_ realize that animals have lived on this planet millions of years without "paying" anyone. The universe provides everything you need to exist
Animals (including humans) spend a lot of time "subsisting". That is, chronically hungry or malnourished. Animals left to their own devices generally consume everything that they can, build up a large population, and then starve back to a more sustainable population. Healthy populations of animals tend to be healthy because some predator is culling the sick and old and generally keeping the numbers down. I don't think you want to look to the animal kingdom as any kind of a model for humans.
I'm sorry but EVERYONE has the right to life, regardless of the cost.
Everyone has the right not to have their life taken away, but no one has a right to unlimited, state-of-the-art healthcare. Money is just a way to quantify resources, and we don't have the resources to give everyone all the healthcare that they want, when they want it. You have to ration it. Different countries take different approaches. In the US, we have 3 different systems of healthcare and so we see wait lists, prioritization (like for organ transplants), restricted availability, and of course dollars. In some countries, they use restricted availability, age limits for certain procedures, and wait lists. And these are the rich countries. The point is, you have to mete out the health care somehow, and while it seems cold to say, "sorry, you can't afford it," I think it also sounds cold to say, "sorry, you are too old to have a kidney transplant." I'm not sure what the right balance is, but I'm willing to discuss it - but I think it is completely incorrect to say that everyone has a right to healthcare - I think that's more of a laudable goal, or an ideal to strive for, but not a right. You do have a right to die, though :)
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: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.
Pfizer spends alot on doctors paying them to write (Score:3)
Pfizer spends alot on doctors paying them to write scripts for pfizer drugs.
Re:See. Patents/Copyright spur innovation. (Score:5, Funny)
You are just on your knees (a very comfortable position for a fanboi though). ... And to the serial downmodding assholes...
*Smirk*
You remind me of a friend I had that wrote me a three page email about how carpal tunnel was killing him.
Re:See. Patents/Copyright spur innovation. (Score:4, Insightful)
And you insult someone who challenges you rather than argue your case. I've debated Mr. I like to lick Butts before. I don't agree with all of his posts but he can make a good case for his views.
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.
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:Choosing the correct tactics (Score:4, Informative)
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.
Pharmacists don't override a doctor's prescription. Lipitor is the brand name of the drug Atorvastatin, which was developed by Pfizer. A prescription is for Atorvastatin (or Lipitor, whatever the doctor) writes down, but the drug is the same whether or not is was made by Pfizer (and called Lipitor) or by a different company (and called atorvastatin). Pfizer has simply made exclusivity agreements that pharmacies would not sell generic versions of atorvastatin. This might be bad for the consumer (price-wise, not health-wise), but they can always go to a different pharmacy if theirs refuses to sell the generic.
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Pharmacy techs here in Canada have full right to offer a generic or brand even against the doctors orders, as long as it's chemically identical to the drug prescribed.
That's one of the benefits of a nation wide healthcare program that subsides drugs to some extent, they're always on the lookout to save a few more dollars.
AFAIK: (I'm not an American, so this is simply "as told to me by a pharmacy tech friend of mine in the states") The Pharmacy (not the tech) can choose to replace a brand with a generic, if
Re:Choosing the correct tactics (Score:4, Informative)
The Pharmacist can in the States... and they can also pay a large sum of money for a license that actually allows them to "write" prescriptions as well. Pharmacy Techs are really nothing more than take the script, pass the script on (maybe count the pills), tell you it's ready, and ring you out.
My ex-gf went to the University of Pittsburgh for Pharmacology so I got to learn quite a bit about how it all works (and learned more in organic chem than I'd like to or ever had to seeing as I went IT)
Re:Choosing the correct tactics (Score:5, Insightful)
Sadly enough, The whole hospital pharmacy apparatus becoming completely automated and mechanized within the next 20 years.
LOL, why is that sad? You just scared the shit out of me about what the meat-based pharmacists are up to! :)
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Standards, the FDA doesn't have the time to inspect all the foreign pharmaceutical lines to the same extent that they inspect the American ones, and the difference is pretty significant. Also, just because a medication is generic does not guarantee that the body will react to it the same way that it reacts to the name brand. It's definitely not common, but it does happen from time to time and most of the time it's because the pills aren't really identical.
That being said, the ultimate reason is that unless
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Yeah, my understanding is that the FDA only regulates (for the purposes of generic vs brand name) the active ingredient. You could have some negative reaction to the fillers, casing, etc. And even the delivery/timing could be slightly different.
A friend of mine was on Nexium, and his insurance made him switch to Protonix - a very close relative, so not really the same thing as a generic substitution... Anyway, he got headaches from Protonix, so his doctor had to write a letter explaining this to the insuran
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.
Re:Choosing the correct tactics (Score:4, Informative)
Quoting the Summary:
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
As long as the Meet or Beat tactic is used I fail to see the problem. If a pharmacy can get a better price on the original Lipitor, make a profit and still beat the generic price fine by me.
Even if the pharmacy has to sign an exclusivity agreement and not carry the generic but still gets to beat the price, fine.
Not every pharmacy carries every drug, and doctors often allow substitutions,. generic or otherwise. In fact they are encouraged to NOT prescribe brand name drugs. Some states [state.il.us] limit this specifically for patients under state programs.
Most drugs that have widely accepted generic equivalences are no longer routinely prescribed with the stipulation of Dispense As Written (DAW), because it raises a red flags with insurance companies and is often a financial burden on patients.
What? (Score:5, Insightful)
A patent is going to expire. The company responds with marketing and by lowering it's price.
That's just horrid~ Someone is working to hard to find ills.
What's that? there are going to create a generic version of the drug they created? OMG!!1!!!
Re: (Score:3, Insightful)
It does show how much they were raping the system and users, their cost have not gone down but wow its now much much much cheaper and yet they will still turn a profit
let me shed a tear for them.
Re:What? (Score:4, Insightful)
NO one is shedding any tears. Iw as simply stating there is no story hee.
And making a lot of money is a fair trade off for the amount of science they do, and the number of new drugs.
Now it's expiring, and it will be cheaper.
I would like to point out that the article has a lot of statements from the author with nothing to support them.
The story her, if there really is one, is how the generic companies are whining they won't be able to compete with the lower prices.
The point of generics was a low cost alternative. It' it's already low cost, they go away.
Re:What? (Score:5, Insightful)
i think there is a story here. we should compare this expiring patent to the copyrights (which it appears never expire, as they just extend it any time it gets close)
So we see this patent expiring and the company that holds it is suddenly becoming more competitive to stay in business and the consumers are winning because of it.
now i wonder what the *iaa would do if their copyrights were starting to expire...i suppose they would have to do something to remain competitive, and the consumers would win because they would be able to get cheap media.
however the *iaa is lazy and don't want to have to do that extra work, and so instead they have fought to keep copyrights perpetual.
Re:What? (Score:5, Insightful)
Exactly. They never should have been allowed to create the drug or sell it in the first place. The whole idea of "whoever does the work is the one who should get the reward" is evil. Pharma companies should not be allowed to engage in research, earn profit, or do anything except bleed money into the pockets of lawyers and socialists. Anyone should be able to simultaneously cash in on another company's research and sue that company. Drugs happen by magic, and don't tell me otherwise; effort has nothing to do with it. Screw people with high cholesterol, they're old while entitlement-driven people are young, it doesn't affect the young so to hell with anyone except the young. I'm ENTITLED.
May you die of a heart attack for want of an effective drug.
Re: (Score:3)
What are you suggesting? That they slammed a few beers, got a bunch of chemicals from the local supply store, dumped them into a vat, and out came Lipitor with minimal effort? Or that someone was -this- close to creating Lipitor and Pfizer came in, said "we should move that over there," then patents the whole thing?
Credit where credit is do. I do -not- like Pfizer, in fact you might even say I -hate- Pfizer, but your line of reasoning is absurd, regardless of my exaggerated examples.
Re:What? (Score:5, Insightful)
Right, but they're not lowering their price as much as the generic. They're negotiating deals with your insurance company so your co-pay for the name brand will be lower than generics, even though the rate the insurance company actually pays for brand-name Lipitor would be higher than the generic, so you save $5 on a copay but the insurance risk pool loses $50, because the drug company is insulating you from the underlying costs and distorting your buying decision.
It's classic drug company tactic- they'll hand out "coupons" or "drug benefit cards" that defray the excess cost of a brand-name copay over a generic copay, so if your brand-name copay on a drug is $40 and the generic is $15, Pfizer will pay you the $25 difference to buy the brand name. They can afford the difference because they're probably profiting over $100 on the bottle, you just don't see the cost to your insurance company at the point-of-sale, it gets turned into higher premiums. It's a big part of why prescription drug insurance is so expensive in the US, several states have banned manufacturer drug coupons and This American Life [thisamericanlife.org] did a whole episode on it a year or two ago.
Capitalism (Score:3)
Hey, they are just taking care of their stockholders Nothing wrong with it, right?
Capitalism, it just works, bitches.
In other news (Score:5, Funny)
Today Pfizer announced results of a new study showing that cholesterol has nothing to do with any health problems whatsoever, but water can kill you. Simultaneously they announced the start of trials of a new drug to control this menace, tentatively named hydroprofitor.
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:In other news (Score:5, Informative)
Yep. The first one that comes to mind is claritin.
From what I remember, claritin is a... prodrug? - it metabolises to something else in vivo. So when they patent expired, they started marketing the metabolite instead, which they got a new patent on.
I've heard of other cases where drugs, previously a mix of L and R isomers became generic, so they launched a new drug with just one of the isomers.
Kind of nauseating, really.
Loratadine was eventually approved by the FDA in 1993.[2] It accounted for 28% of Schering's total sales[citation needed]. The drug continued to be available only by prescription in the U.S. until it went off patent in 2002.[citation needed] It was then immediately approved for over-the-counter sales. Once it became an unpatented over-the-counter drug, the price dropped precipitously, and insurance companies no longer paid for it. In response, Schering launched an expensive advertising campaign to convince users to switch to desloratadine (descarboethoxyloratadine, trade name Clarinex), which is the active metabolite of loratadine. A 2003 study comparing the two drugs found that "There is no clinical advantage to switching a patient from loratadine to desloratadine.
Re: (Score:3)
Sorry for self reply,
My recollection of chemistry is rather shit, so i bungled that. enantiomer. that's the word.
I'll let wiki tell about the isomer differentiated drugs, there are some specific examples there too.
"Enantiopure_drug" [wikipedia.org]
Comment removed (Score:4, Informative)
Re:In other news (Score:4, Informative)
Read the actual decision.
There were a number of reasons why the actual decision is sane.
To recap the high points of the slashdot thread.
The actual claim forbidden was something like "Drinking water regularly can help prevent dehydration".
Dehydration, in its medically significant form - is not usually caused by the lack of water. ... all do the same thing, as well, or better than water.
Drinking water when dehydrated for reasons other than not having access to water may do nothing, or be counter-productive.
Drinking water regularly does nothing to stop you needing water in the future.
Water is not special in providing hydration - coffee, fruit-juice, grapes, oranges,
Protect profits over public health. (Score:3)
Damn public! how dare they want affordable drugs for healthcare!!!!
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: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:Patent vs Copyright (Score:4, Insightful)
As a rule, politicians are white, elitist, and rich.
White rich elitists tend to eat overly calorific foods, that cause high cholesterol.
As such, I would not be surprised if many politicians have scripts for cholesterol, hypertension, and liver disorders.
Getting between your meal ticket and his life sustaining medications is not good PR.
Compare to copyright, which is not life threatening or life regulating (at least once you pass a certain income bracket. Ahem) you can clearly spot the reasons why, aside from insider trading and the like, politicians don't get lobbied for quite the same things from the pharmecutical giants the same way they get lobbied for copyright extensions from big media.
If you throw in the more tinfoil hat type thinking about the control of information and culture that makes the public easier to police and control, I think you have a winner.
HUUGE PROFIT MARGIN (Score:3)
They have a huge profit margin because of the stunning breakthrough they funded when they backed Bruce Roth.
Roth first synthesized atorvastatin in 1985. For the discovery, he received the 1997 Warner-Lambert Chairman's Distinguished Scientific Achievement Award, the 1999 Inventor of the Year Award from the New York Intellectual Property Law Association, the 2003 American Chemical Society Award for Creative Invention, the 2003 Gustavus John Esselen Award for Chemistry in the Public Service, the 2005 Iowa State University Distinguished Alumni Award, and the 2006 Pfizer Global Research and Development Achievement Award.
Roth was named a 2008 Hero of Chemistry by the American Chemical Society (ACS).
Re: (Score:3)
What's amazing is how they extended the patent (Score:4, Informative)
Great, more incentive for doctors to overprescribe (Score:3)
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.
This is not the way capitalism works. (Score:3, Insightful)
Pfizer is a for-profit company, and that they want to patent their product and profit from their ingenuity is great. That's how capitalism works: sell a good product that people want to buy, turn a profit, succeed.
However, drug patents last up to 20 years. Rather than riding heavily on Lipitor profits for that period of time, and releasing alternate versions of the same drug over and over again, wouldn't it have been prudent to turn efforts toward producing and patenting the Next Amazing Drug?
They knew the day would come that Lipitor's patent would expire. If, in spite of the massive profits they've made from this and other products, they couldn't innovate anything to replace that massive chunk of profits, then they have to bow out gracefully instead of going through ridiculous, unsavory means to ensure revenue.
Profiting morally from a good profit is capitalism. Tactics like this are not.
Re:This is not the way capitalism works. (Score:4, Insightful)
You make an interesting point, and I agree that we don't hear about those huge discoveries very often, but I worry that you have been horribly misled.
I am a medical student, and I've spent years in basic science research, studying cancer and genetics. While certain aspects of healthcare aren't perfect (distribution of federal research funding, ill-gotten pharmaceutical gains, etc), I honestly believe that medicine has come a long, long way and continues to advance at fantastic pace.
To address your specific comment:
- There is no vaccine or cure for "the common cold", and likely, there never will be one, partly because "the common cold" can be caused by any of dozens of different pathogens. And by itself, rhinovirus, the oft-cited culprit, mutates far too quickly to make a cure or vaccine achievable.
- A cure for Alzheimer's: Alzheimer's is still not understood fully enough to yield curative treatment, but research on the disease, especially on its genetics, has come VERY, VERY far. You would be amazed if you took a look.
- Parkinson's: Sure, no cure on this either. But again, you would be amazed at the research that's been done. And you would be even more amazed to see what treatments are out there. In med school, we've met patients who have undergone treatment for Parkinson's, and their lives had improved significantly with little inconvenience. One treatment: a little surgically-implanted a little remote-control patch in your brain that supplies dopamine to the right shots, helping patients to regain independence and control their movements again. Absolutely incredible.
It's like you picked out random things about which medicine's understanding is still fuzzy, and you used them to illustrate that medical research is completely stagnant. I disagree fully. I dare you to go back 20 years and get infected with HIV. Treatment of that devastating infection has made astounding progress in just a couple of decades. Go back a little further, before the smallpox vaccine. Compare current treatments for diabetic retinopathy or macular degeneration with those available maybe 15 years ago. Check out the strides - the LEAPS - that have been made in cancer genetics in just 20 years and how they've improved the speed of diagnosis and treatment of cancer, and have significantly improved prognosis.
Medical science isn't stalled. Yes there are complicating factors. But to say it has stalled is to ignore the massive efforts and accomplishments of scientists who have significantly improved everyone's health.
Old News, (Score:3)
If you take a *satin drug... (Score:3)
All of these cholesterol drugs including Lipitor work by mucking about with your liver. I am type 1 diabetic and my doctor prescribed a low dose of Zocor (a similar cholesterol drug). After about a year I started experiencing weird join pain and nerve problems. My first concern was ALS - I knew someone who died of it. I saw doctors, including a neurologist, had lots of tests done . Nothing. It wasn't until a year later that I read an article in the LA times about Zocor being withdrawn from the market at a higher dose because of the same symptom that I realized what was causing them. None of my doctors told me anything.
My cholesterol isn't really that high. My doctors prescribed it because of the diabetes. I stopped taking it and the pain improved dramatically. At one point it was so bad I could barely lift the top off of a coffee can.
The other side is the garbage that we call food. Most of it is loaded with trans-fatty oils and added sugars. Forget all of the claims on the front of the box - get a microscope and read the ingredient list on the back. If there are hydrogenated oils or lots of added sugar (any form of corn syrup, anything with *ose, "designer" sugars such as honey, molasses, evaporated cane juice, etc. Try to find foods that have fewer ingredients that can pronounce you actually might have in your kitchen. They are available and often don't cost much more. Some of the more reliable brands are Kashi, Amy's, Trader Joe's, Edy's, Martins, etc.
If you take any of these drugs, look them up on youtube (don't bother with webmd or anything similar as they are useless). The results might scare you.
Re:If you take a *satin drug... (Score:5, Insightful)
what a waste this company is. (Score:3)
They followed this up by closing down their most productive R& D sites globally.
Vast personal profit for the execs, decades of experienced researchers tossed to the wind, and their "if we screened X million candidates with this robotic platform and got N useful hits, if we screen X^5 million via robotic screen we'll get N^5 final candidates and reap the rewards" strategy didn't work worth a darn. Big surprise.
That's what happens when suits (some hired from companies with a GREAT track record for drug development- like.... McDonalds) take over a scientific company.
A few more rounds of boosting stock price via layoffs and this will be a little has-been of a company.
Nice work there guys. Way to destroy a company. You could have done the same thing by just buying a pizza chain or something and selling off assets for personal gain, and not cost the real human race useful medications.
Pfizer did not discover Lipitor... (Score:5, Informative)
Pfizer did not discover or invent Lipitor. Lipitor was discovered and invented by Warner Lambert/Parke-Davis in Ann Arbor, Michigan, in an industrial setting, not academic. Warner Lambert/Parke-Davis partnered with Pfizer to develop and market the drug and share the profits. From the profits of Lipitor alone, Pfizer was able to buy and takeover Warner Lambert/Parke-Davis, where it closed the Ann Arbor site a few years later in 2007 (http://www.youtube.com/watch?v=02krhNFfEq4). Of the 2200 scientists at the Ann Arbor site, approximately 600 remained with the company, of which approximately 300 relocated to Groton, CT, Pfizer's legacy discovery research site. The other 300 scientists relocated to sites in St. Louis, MO (winding down and eventually closing), La Jolla, CA, and Sandwich, England (now in the process of closing - over 2000 jobs lost). In these relocations, Pfizer was very generous and bought families homes for the original price and paid to relocate employees and their families across the world. Pharmaceutical site closures are very expensive and impact families and disrupt local economies significantly; purchasing employees homes is an incentive to retain talent. Pfizer assisted employees buy new homes by paying for real estate agents and paying closing costs on homes. In 2009, Pfizer bought Wyeth Laboratories and laid-off tens-of-thousands of scientists, many of them from Ann Arbor, MI, its most successful discovery research site ever based on the site talent, technology, and number of marketed drugs from that site, Groton, CT, and many from Wyeth various sites in the U.S. Several years ago, Pfizer was able to reduce the cost of manufacture of Lipitor more than 200-fold using a series of natural wildtype and industrially modified enzymes.
Pfizer's former CEO Jeffrey B. Kindler and former CEO of McDonalds, became so unpopular with the rank-and-file that he earned two nick-names, first "McBurger," and finally and more commonly known as "CLOWN SHOES" (http://www.youtube.com/watch?v=clgRId8x0ZM). Employees would and still post about dissatisfaction with the company's direction and leadership on BioFind.com (http://biofind.com/rumor).
Re:Pfizer did not discover Lipitor... (Score:5, Informative)
Liars and Idiots (Score:3)
Of all time? (Score:5, Insightful)
Surely Alcohol is the best selling drug of all time
Not Generic YET (Score:5, Informative)
Lipitor has had an ANDA filed for a generic version by Watson, yes. However, the law allows Pfizer to grant a 180 day exclusivity contract to a manufacturer of their choice (in this case Watson) for the ANDA. To those affected by this drug going generic: IT HAS NOT GONE TRULY GENERIC YET! Wait until the 180 day exclusivity contract expires (in 179 days) and the true "invisible hand" will take effect in the market.
In the meantime, you're most likely going to need to get the BRAND NAME Lipitor for it to be covered to the fullest extent by your pharmacy benefit manager ("insurance company")! These PBMs get rebates (NOT kickbacks) to lower the cost of the brand-name drug, so it's financially advantageous to the member to not cover the generic yet. Here's why:
Lipitor (brand) 90ct bottle = $550 retail, minus $330 in rebates = $220 total cost of drug.
atorvastatin by Watson (generic) 90ct bottle = $530 retail, minus $0 in rebates (Watson doesn't offer any) = $550 total cost of drug.
(These amounts are fictional, however they represent true real-world scenarios.)
Disclaimer: I work for one of the US' largest Pharmacy Benefit Managers in the Clinical Review department. We had a meeting today regarding all of our Medicare Part-D patients and how they're affected by this specific drug going generic. No suits were involved and the members are receiving the best possible drug savings until the exclusivity contract expires. Once it expires the new generics will be placed on the tier-1 ("generic") copay structure.
Re:"Free" Marketplace (Score:4, Informative)
The free market just kicked in. The drug companies are now playing meet or beat. Translation: competition works.
What's wrong with that?
The problem existed PRIOR to the patent expiring, where artificially high prices existed.
Go tinker with that set of rules if you dare, but don' blame the free market just because prices
come down the minute the market actually becomes free.