Report Says Patents Prevent New Drugs 381
An anonymous reader writes "Current orthodoxy claims patents encourage innovation, by allowing developers to enjoy profitable monopolies on their inventions which in turn inspire them to create new inventions. A new report by the non-partisan General Accounting Office suggests that this orthodoxy is wrong — at least when drug companies are involved. According to the report, existing patent law allows drug companies to patent, and make substantial profits off of, "new" drugs which differ little from existing medicines. Given high profit margins on very minor innovations, the report argues that drug companies have little incentive to produce innovative new drugs. In other words, current patent law actually discourages drug companies from producing new medicines.
Responding to the report, Senator Dick Durbin (D-IL) released a strongly worded statement suggesting that a legislative response will be forthcoming. "The findings in this new GAO report," said Senator Durbin, "raise serious questions about the pharmaceutical industry claims that there is a connection between new drug development and the soaring price of drugs already on the market. Most troubling is the notion that pharmaceutical industry profits are coming at the expense of consumers in the form of higher prices and fewer new drugs.""
Exaggeration (Score:5, Insightful)
Re:Exaggeration (Score:5, Insightful)
Thats not the point at all,
the deepepast implication is that drug companies are incentivised to treat and not cure
the patent structure does not create market conditions that would prompt real inovations for instance cures.
*Cure's* are not good for busness.
And this i find truly disturbing.
Re: (Score:2, Insightful)
Re:Exaggeration (Score:5, Insightful)
The medical system is HUGELY biased to work on treatments for things not working properly, rather than work on prophylaxis. This will never change unless we go to socialized medicine, because people fundamentally go to see a doctor when they are sick, and not to manage their future potential illness burdens.
I also take issue with Durbin saying this indicates a problem with the patent system. If a new drug comes out that offers no additional benefit, but has patent protection, WHY DOESN'T THE CONSUMER BUY THE GENERIC? That is the real problem. Capitalism fundamentally depends on informed consumers. If anything, I would urge Durbin to consider legislation to inform the consumer about non-patent-protected drugs in a reasonable way so they would not waste their money on a slickly marketed new drug that is only just as good as a generic.
Dental care? (Score:5, Informative)
Then why are teeth different? It's common for United States residents to have their teeth cleaned by a professional hygienist and looked at by a dentist (doctor of dental surgery) twice per year.
Because as I understand it, new drugs rarely offer "no additional benefit". For instance, Allegra (fexofenadine hydrochloride) is less toxic to the heart than Seldane (terfenadine), and Cialis (tadalafil) lasts longer in the body than Viagra (sildenafil citrate). The ADD medication Strattera (atomoxetine), a norepinephrine reuptake inhibitor, has the advantage over the previous standby Ritalin (methylphenidate) that reuptake inhibitors are an indirect stimulant and thus take longer (two weeks) to start working. This may sound like a disadvantage, but unlike amphetamine style stimulants, reuptake inhibitors does not lend themselves to abuse and are not scheduled as controlled substances. But you may be right about Nexium (esomeprazole magnesium) vs. Prilosec (racemic omeprazole magnesium), as it appears that the biggest difference is the dosage: Nexium is prescribed at higher doses than Prilosec was.
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Then why are teeth different? It's common for United States residents to have their teeth cleaned by a professional hygienist and looked at by a dentist (doctor of dental surgery) twice per year.
I've seen this answered before in the context of British people. The US stereotype says that British people have bad teeth, while a British person is unlikely to notice. This is because in the UK, anyone can go and see a dentist and get free care[1]. This means that having your teeth poked is just another inconvenience. In the USA, however, it is a status symbol. Being able to get your teeth cleaned and repaired professionally is only an option for the wealthy or those with good jobs which come with a
Re:Exaggeration (Score:4, Insightful)
This does not follow. "Socialized medicine" is a very broad abstraction that can take on a wide variety of forms. Canada has what is normally thought of as socialized medicine, but our health care delivery system is still very much oriented toward "people go to see a doctor when they are sick." We do a better job of some aspects of prophylaxis, particularly with regard to peri-natal care, than the United States does, but because our system is one of socialized health insurance where doctors are still nominally private practitioners we have many of the same ills the U.S. health care system has, albeit at vastly lower cost and with somewhat better outcomes in terms of overall lifespan.
How a health care system is organized is fundamentally independent of whether or not it is socialized in some respects. One could have doctors as salaried employees of health-care corporations in a private system, or one could have doctors as mostly private practitioners in a socialized model as we do in Canada. Far more important than "who pays" is the nature of the payment system, and so long as we think of health care insurance as insurance there will be fundamental problems, because unlike other forms of insurance, absolutely everyone who has health care insurance will eventually get sick and die, unless it is offered only on a term basis, which most people would find unsatisfactory.
Canada's socialized system is not totally dissimilar from HMOs in the U.S., and both systems do pay more attention to preventative care than traditional insurance, but there are much easier ways to improve the finances of such organizations: de facto rationing of care (as in Canada) and practical selection of patients so that you serve primarily the healthiest part of the population (as in the U.S.)
I don't have any solution to these issues. Having lived in the both the U.S. and Canada, and as an businessperson, I am much happier with health care services and costs in Canada than in the U.S.--the extra I pay here in taxes is about equal to what I paid in health care premiums in the U.S. as an employee of a large institution, and if I were still in the U.S. I would not have been able to start my own business due to the risk of losing coverage. But no one sane is going to claim that the system here is ideal.
As to the question of why "consumers" don't choose generics: who is the consumer? The patient? The doctor who writes the perscription? Or the insurance company that pays for it? Even assuming it is the patient, the bulk of big pharma budgets are spent on advertising and marketing, and generics don't generally have the kind of profit margins required to compete with that.
Re:Polio and HIV (Score:4, Interesting)
The same interest in curing HIV exists today, its just a harder problem to solve.
It's also easy to blame big evil drug companies for providing treatments rather than cures, but what about the big evil HMOs, who want to minimize costs? Certainly Kaiser Perminente and other HMOs are interested in cheap prevention measures, rather than expensive ongoing treatments.
Another issue preventing drug use is the lack of any mechanism similar to patent protection to induce finding new uses for existing drugs.
Consider Welbutrin: it was found to work better than other anti-depressants for many people, but after a media panic stunt that associated the drug with seizures, doctors were afraid to prescribe it. It was later found that the drug was also effective in helping people stop smoking. The Welbutrin name was tainted that its company rebadged it under a different name: Zyban. It was then proven that Welbutrin had no real danger for most people, and the seizure side effects associated with it only really affected people who already had seizure problems, and even then had less risk than alternative treatments.
Then Welbutrin (busparin) went generic and the profit motive for finding and proving new uses for the drug ended. Sales went to generics manufacturers.
Meanwhile, studies where already showing that welbutrin worked for many people as an aphrodisiac and could help them rebound from problems involving low libido, among other things. Unfortunately, not only was such a drug considered too racy (this was before Viagra), but since the drug maker would have to spend millions in clinical trials proving its efficacy, it made no sense to do so because there was little patent protection still available on the drug.
How many other drugs have known uses, but can't be formally proven because the costs are prohibitive? It's obvious that patent protection DOES create a strong profit motive for finding new uses for new drugs, but it does nothing for drugs we already have and know a lot about - drugs we know are fairly safe, and which have promising new uses.
A non-patent system, where new drugs are discovered and new uses are developed by non-profit 'open source' volunteers wouldn't have the money to do extensive formal clinical trials, which take years and can deliver huge disappointments. How far would Linux or any other FOSS project go in a software world where every program had to prove itself flawless over a long and expensive qualification testing period? Software is wholly unregulated, and anyone can dump out junk and sell it. Drugs aren't like that at all.
The only system that works at all is the huge profit potentials offered by patents, and it has serious shortcomings. As long as the FDA restricts new developments very conservatively, and as long as people can sue drug companies and win huge damages for any risk involved in taking a drug, we simply won't have full access to the drugs we already have.
Apple's Billion Dollar Patent Bluster [roughlydrafted.com]
Re:Exaggeration (Score:4, Insightful)
What complete and utter bullshit.
This is the contrapositive of the same generalization about Capitalists (that it's implicit and assumed that government is bad, and only the Free Market can solve problems).
Socialism addresses the FACT that not all problems can be solved by Market Economies. Not all human needs are met by Market Economies. This fact became evident when the Mesopotamians got together some thousands of years ago to do something about the impact of seasonal flooding on their agriculture. They thrived as a civilization where nomadic cultures that lived in that region for the previous thousands of years failed.
There is a point to civilization. And that point is to collectively solve problems and meet needs. Leaving everything to "natural forces of the market" is akin to leaving your crops to deal with the tender mercies of natural floods. Can the farmer prosper if he is then forced to give all his food away (which was the case, in ancient Mesopotamia)? Of course not. That's why (one reason) Mesopotamia fell to Persian invasion, and why the Soviet Union failed.
A civilization that succeeds, empowers individuals, but individuals still need to work together for mutual benefit in order to survive.
no one can tell me why I should be so excited to give government so much damn power over my life.
It would be nice, if humans were just naturally compelled to care about their fellow humans. But by nature, humans are selfish, and distrustful. In any case - in America - pursuing this Libertarian ideal, at least for the past 10 years or so, has meant giving your vote over to the Republican Party, who damn well does want to give the government a lot of control over your life - to their perverse Theocratic Socialism. And now; Corporate Socialism (which is exactly what a patent is).
Personally, I think that what is broken with our US Healthcare system could (in theory - probably not in practice) could be fixed if much of the regulatory mess that is our patent system, and the influence of the AMA, could be radically reformed, and more strict limits on healthcare corporate consolidation enforced. Absent those reforms, a single-payer system looks very attractive. On the other hand - given the corruption in our current system, lobbyists, and politicians, (especially very clearly illustrated by Medicare Part-D) I have no confidence that a single-payer, or any other form of socialized medicine, could possibly be executed in good faith, in the US.
I fully expect the situation in the US to continue on for some time, perhaps as long as 10 years, in a continually downwardly spiraling fashion, until enough wealth has been transferred out of the country, that we will have effectively no domestic healthcare for the vast majority of our population.
Here's what I think will happen:
http://www.bloomberg.com/apps/news?pid=nifea&&sid
The individuals who will not be served by this system, will be in no position to effectively fix it (as is the case today).
Gaaah!. Tired of hearing this! (Score:5, Insightful)
If I could come up w/ a cure, you can bet we would make it. See, we have competitors. Who make a lot of money. If we could make a quick & easy cure, we'd make it, make a ton of cash, and move on. As an example in the last couple of years, Merck made their HPV vaccine to PREVENT cervical cancer. One time, cheap shot, and they've lost a potential cancer patient. Of course, it took forever to get to market because the Republicans think that preventing HPV infection will cause teenage girls to become whores. If you want to look for the reasons our health care system is so fucked up, I suggest that you follow not only the money, but the ideaology.
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I have no doubts that Pfizer, Merck, Novartis, AZ, and all the others are researching all sorts of interesting things that would be a great benefit to society. As you pointed out, if (some drug company) invents a real cure for AIDs, they will make a bazillion dollars and their stockholders will be able to hire Trump and Gates as their shoe-shine boys.
As a researcher, I imagine that you have personal, social,
Re:Exaggeration (Score:5, Insightful)
True, but who said the drug companies' purpose in life is to cure Humanity's ills? They are in it for the money, and free to work on whatever they want. But the point is, other entities have the explicit purpose to cure illnesses: nonprofits and universities. Funding for them is mostly donations or government grants (and there is plenty of money in both, but should always be more).
We shouldn't expect too much from the drug companies; they are money-seeking corporations, nothing more, and often corrupt to boot. What we should do is make sure that donation and grant money for nonprofit research is plentiful, and rely on them to solve our health problems.
None of this detracts from TFA's point, however, that the patent system may need modification: even if we don't expect the drug companies to cure illnesses, we still can change things so that they do what they do do (pills that alleviate symptoms) better.
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Re:I disagree (Score:5, Interesting)
Here in Wales, we have something called the Technium Project. The idea is to have a set of buildings each dedicated to a particular technological field. They are filled with business incubator units (which are expensive, but quite easy to get subsidy for). The idea is that putting all of these businesses close to each other leads to sharing of ideas.
One of the buildings in the project is called the BioTechnium, and is intended for biotech start-ups. Since the building came online, only one person has been employed in it; the building manager. In spite of the fact that it was designed with biotech in mind (decontamination and isolation facilities, etc), there is not a single biotech start-up moving in. Why not? Because no one will fund a biotech company that doesn't have a large patent portfolio. You can't get into the industry without a cross-licensing agreement with all of the major players, and you can't get that without a load of your own patents to offer. The result? A barrier to entry so high no one can get over it.
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If you can cure a major disease with a drug, the monetary gains would be vast beyond imagining. A pill to cure cancer? You could charge whatever you liked, and a patent on that, well, it would be valuable beyond the dreams of avarice. Also curing instances is not the same as preventing occurances. Repeat instances would crop up all the time.
Did you know for instance that Garlic kills the HIV Virus outright? Stone dead on contact
Re:Exaggeration (Score:5, Insightful)
Re:Exaggeration (Score:5, Insightful)
If you have an exclusive right to do something with no chance of competing with anyone else then there is no incentive to do anything to make the situation better, good example, mall food service. Many get 'exclusive' agreements for their type of food. So if a bakery opens then another competing store producing a bread product will be denied and there is no competition so the store in the mall can get away with whatever they want because what choice do you have?
I think its time to abolish patents in their current form. Or severely limit the time period they are effective for. 1 year for medial items, to allow a manufacturer to recoup their R&D costs and after that its the best fastest most efficient that would survive instead of the the company with the most Patent attorneys. Make them compete! There is no competition in a monopoly.
Re:Exaggeration (Score:5, Informative)
Exactly. I'm a clerk in a pharmacy and on a particularly non-busy night we were all talking with the pharmacist about this sort of thing. He gave an example of some company which came out with Drug X (can't remember which one). As the patent on Drug X was about to expire, they created "Drug X Gel Capsule... better than before!!!" Of course, doctors, not really knowing, started prescribing the new X Gel Capsule, which had a new patent and thus no generic (and by this point, the original X's patent had expired and had cheaper generics).
Well, the pharmacist pulled out one of the new X Gel Capsules. Guess what it was? Just the original Drug X encased in a gel cap. That's it. A regular pill in a gel cap.
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Re:Exaggeration (Score:4, Informative)
So it looks to me like the legal team of a corporation is now required to become a profit center, rather than just provide protection for company interests. With rising drug costs far outpacing inflation AND the great profit increases for most drug companies, it seems like the legal teams and the multi-billion dollar marketing campaigns are paying off.
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Re:Exaggeration (Score:5, Interesting)
Without patents, patent-heavy fields like pharmaceutical research fall into cutthroat, razor-thin-margin price wars - but that is not a bad thing. In fact, it's not too different than desktop computers, where we've seen manufacturers keep up with Moore's law for a remarkable amount of time, even while having to struggle to break even on almost every product. Again, patents do not exist to provide peace of mind to investors; they exist only to promote progress. If ending them, and forcing pharmaceuticals to (*gasp*) innovate to stay in business (and even having a few go out of business when they fail to!) is the best way to promote progress, than that is exactly what we should do.
Of course, All of that only makes sense if Congress is competent and not corrupt... so much for that then.
Re:Exaggeration (Score:5, Insightful)
Well, cutthroat razor-thin margins generally aren't bad, but it's hard to imagine how it would be profitable to sink billions of dollars and 20 years into developing a drug, when someone can compete with you when they're already billions of dollars and 20 years ahead, merely by using your published formula.
The article's point was not that "patents" are bad, but that allowing an additional patent for an incremental upgrade is bad.
In fact, it's not too different than desktop computers, where we've seen manufacturers keep up with Moore's law for a remarkable amount of time, even while having to struggle to break even on almost every product.
Well, yes and no. It's the same in that the driving force behind Moore's law, the processors, are patented (rendering your example moot). It's different in that, even if you could legally copy the processor design, you'd have to put up a huge amount of capital (though you wouldn't need to do the research, that's a much smaller fraction of costs of bringing to market).
Again, patents do not exist to provide peace of mind to investors; they exist only to promote progress. If ending them, and forcing pharmaceuticals to (*gasp*) innovate to stay in business (and even having a few go out of business when they fail to!) is the best way to promote progress, than that is exactly what we should do.
Pharmas do innovate! And they do fail sometimes, even with patents. You seem to think that just because they don't have to struggle as much once they have a patent, they're not competing. That ignores the research competition they have to go through to find patentable medicines. Whenever someone tells me that a pharma is earning monopoly profits for doing nothing because they have a patent, I almost have to ask what they think of veterans drawing a pension. "Oh, okay, great, big deal, you fought some war a while back. What are you doing for us *now*? Why should we pay you this pension *now*?"
Just to be clear, I don't want to come across as a pro-patent extremist. My point is that the issue is a lot more complicated than people on either side give it credit for.
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Good. But would they have innovated more with no patents? With 3-year patents? With 60-year patents? That's the question to be asking here, not "they innovate, so everything's OK."
Yeah, but you're missing the point. Sure, without patents, all these companies might be doing a lot more research and staying X years ahead. However, they'd also keep their medicines locked up as trade secrets and the general public would never know how they work. The whole point of the patent system is that things can be released to society after they've been invented. That way, other companies can build on the ideas. Without patents, each company might be more advanced than it is now, but they'd eac
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I think we should shift more to a system which doesn't reward invention so much as it rewards the amount of effort that went into inventing it.
Perhaps some sort of "limited" p
Re:Exaggeration (Score:4, Insightful)
There are bound to be these kinds of issues no matter what the implementation of patents is.
One problem with treating an idea as property is that unlike real propert such as a a farm, it's boundaries cannot be clearly drawn. It would be clearer to draw the boundaries of the patent monopoly around a market -- say erectile dysfunction treatment. However, this would really damage innovation. If it hadn't been for WW1, American aviation would have been set back years by the Wright company's use of their patent for "wing warping" to block the introduction of modern (and very dissimilar) control surfaces by Curtiss. In effect, they were using their patent to gain control of the market for machines capable of controlled flight.
Drawing the boundaries of an invention narrowly enough to permit competitive inventions means that any patent system that does not destroy competition must encourage some level of risk minimizing "me-too" inventions. The biggest uncertainty is often whether the public actually wants a better mousetrap. Now that the "Blue Pill" is such a runaway hit, erectile dysfunction is an attractive target for drug company investment, even though Viagra is effective,and probably as safe as any equivalently effective drug is likely to be.
Patents are an artifice. In real property, such as land, exclusive use is needed to enable the owner to attempt to find an efficient use. The same plot of land can't grow wheat, corn, and serve as a parking lot. Ideas aren't like that at all. "Propertizing" ideas makes their use inefficient; it's only done to incent at least some risk taking. You don't have to go so far as saying patents never work to concede that no system of patents works perfectly, or is totally free from perverse incentives.
The answer is, of course, that we can't rely exclusively upon the private sector to do everything for us. Some people seem to be unable to visualize a middle ground between relying on the private sector for everything, and restricting the private sector so that only the government can get things done. I think that we shouldn't expect the to cure cystic fibrosis when creating a Viagra competitor is so much easier, safer, and profitable. On the other hand it is doubtful that Viagra would have become available at all if it were not for the private sector, because it was not effective at all for its intended functions: treating angina and hypertension.
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Reading your post brings this idea to mind: What if we were to treat patents with a tool similar to that which we use to treat the other great artifice of our tim
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Just because old Al Greenspan was a benevolent dictator with the Fed, doesn't mean that unacountable insulated oversight boards are inherently better than a transparent democratic process. It just means that we were damn lucky to have had someone like Greenspan all those years.
Any system that relies
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More like: (Score:2, Interesting)
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You're right. The FDA is useless. (Score:3, Insightful)
And while I understand that the urge to deteriorate into meaningless hyperbole is nearly irresistible when writing a two sentence post, let's not lose touch with reality. Every year drugs with amazing complexity are trialled and approved. Say what you want about drug companies, but advances in the pharmaceutical industry are just as--if not more--impressiv
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Is it really that rare? Celebrex, which is similar to Vioxx, is still on the market. And though few drugs kill you quickly, many drugs poison you slowly, and your death, though blamed on the disese, may have been agg
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And as for Celebrex, it's only similar to Vioxx in that they're both Cox-2 inhibitors. Their pharmacology is very different. Which actually illustrates my point: these things are tough and we need solid regulation on the industry.
"At least snake oil, though useless, didn't kill people."
You do realize that 'snake oil' isn't actually a real thing? To say that whatever concoction being peddled on any given day wasn't lethal is a pure guess on your part
Re:You're right. The FDA is useless. (Score:5, Insightful)
First, everything is a balancing act. The maximum extension of your logic is to legalize any substance that has shown any promise in saving lives without any testing at all. After all, we can't "kill people" by not giving them the drug, can we? But that is simply moronic. People--especially those with a proverbial gun to their head in the form of an illness--simply do not have enough information to make a decision about what non-regulated chemical to take. And without testing and regulation, doctors don't have enough information either.
Second, how many people would be "killed" if they couldn't trust the drugs that are prescribed for them? Horror stories and dead bodies would stack up and people would doubt the safety of all medications. After all, in an unregulated market just because a drug says it's Vicodin or Valium or Vioxx, it doesn't mean that it actually is.
Third, the crux of your point is just a guess. How would you possibly know what the "total sum" of "deaths from snake oil" are compared to the deaths that *MAY* have been prevented if a drug was approved quicker?
Fourth, if you have a serious illness that may be treatable with a drug in the pipeline you can (with your doctors help) get in on the late-stage trials. Many people are on experimental pipeline drugs.
Fifth, the idea that regulation "kills" people by not giving them a treatment fast enough is akin to saying that a paramedic kills the gunshot victim because he couldn't get him to the hospital in time. In reality, it's the gun shot that kills him. And maybe the paramedic could have saved him if he'd gone 110 MPH and blew thru every intersection but there's no way of knowing how many other people that would've killed.
And finally, you need to look no further than the hippocratic oath. "First, Do no harm." Your "regulation kills people" idea is the literal contradiction of that.
And really, comparing marijuana, which is literally ripped out of the ground with no further processing, to todays prescription drugs is a little overboard. The pharmacology and pharmacodynamics of the average drug are insanely complex.
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quacks kill.
the arsenic wafer said to relieve "female discomforts."
and sometimes fed, one suspects, to the male who was responsible for same.
the typical patent drug of the 1890s was a potent mix of alcohol and opium. given in stiff doses to both infants and elders.
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Even now--with this rigorous testing--we find that some drugs should never have been sold. Vioxx comes to mind.
And what is so bad about Vioxx? If you are allergic to sulfa, need to avoid gastrointestinal side-effects, and are at a low risk for heart disease anyway, Vioxx is an excellent choice of drug (Celebrex has a sulfa group, NSAIDs and aspirin cause stomach bleeding). Especially if you are going to be taking it for a medium term (12 months or less) there is little risk. The studies that show statistically significant increases in adverse cardiovascular events show them for long-term high-dose use; many of
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Well, that's a complete guess. (Score:4, Insightful)
Well, that's a nice guess but that's about it.
I'm no fan of bureaucracy, but the FDA isn't your average government agency. It's completely independent. And the idea that a "private industry" could constrain time and cost and still produce "better" results is amusing to me.
What, exactly, would you expect to be different? The drug companies run the trials. It's always been that way. All the FDA does is provide oversight, review and approval.
And not to be a prick but it's a little obvious that you under-thought this. How would a "faster" trial period possibly produce "better" results? If you're producing a drug that would be taken for extended periods of time, how would you possibly know what to expect if you don't run long-term trials?
A private enterprise has only one constituency: its shareholders. Sometimes the best interests of shareholders and the public at large align, but not always, and I wouldn't feel comfortable even saying "often." I don't care if your liberal or conservative, there are some things that a government just does better. And this is one.
Those that believe in the magical powers of the free-market to regulate itself need only look at all of human history prior to the last 75 years.
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with deeper and more formal research and testing. we might not have had to wait 100 years to learn that aspirin
(a) is not appropriate for everyone and
(b) that aspirin has other, very significant, medical uses than as a mild painkiller.
in the nineteenth century you could sell anything over-the-counter.
that it was addictive and dangerous didn't matter. that it was more
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"Aspirin" itself would likely still be a trademarked term in the United States had we not declared war on the country of origin. World War I and the ensuing revocation of Bayer's IP in the US was a boon to the generic drug industry.
Not unique to pharmaceuticals. (Score:2, Interesting)
If you substantially increased the fee for patent applications then you could hire real experts to review new patents, and that might help solve some of these problems. Of course, many
Re:Not unique to pharmaceuticals. (Score:5, Informative)
At the end of those two years, if you are actively exploiting the idea in a business you can get another 1 year of protection and thats it
The principal is that if a 3 year head start on your own idea isnt enough to get you established in the market then you should probably let someone else do it anyway rather than stifle future innovation
(companies also have to keep their R&D far more secure under this system and they only usually patent just prior to launching to market - this in turns requires a much faster and streamlined patent application system)
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So, no free exchange of information under this system? Is that better?
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The alternative is to patent, sit on it for a while, scalp any other company that wants to do similar for license fees, maybe eventually sell or use the patent yourself... maybe
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Solution to the problem (Score:5, Insightful)
Why this criteria? Because if you have to draw comparisons with other items and state that this application improves incrementally over items 1-n, then it's not innovative and not deserving. Take the pet rock for instance (however trivial and droll):
It's a polished rock with googly eyes, marketed as a "pet". There is nothing like it in existance today.
I'm still not sure it should have a patent, but at least you can explain it in 2 sentences or less, including the all important "unlike anything else" clause. (whether that was true or not is a different issue)
As for funding the patent process:
Make patents holders pay a percentage take to the PTO, paid at least yearly, with a minimum fee of the application itself, increasing by some scale over the years. The older they get, the more expensive they get. Failure to pay on time means it becomes public domain.
I believe such an approach solves several issues, while still allowing invidividuals to profit from their work without undue hardships.
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http://dotank.nyls.edu/communitypatent/ [nyls.edu]
I think this means more or less (Score:2)
Perhaps peer review would prevent these issues. Give everybody who requested a patent last year the chance to review current patents and accept them or not. If not, they need to explain why and an agreement needs to be found by e.g. removing some claims. Something like this might just work.
Something different? (Score:5, Interesting)
I realize that making drugs (or any other product, for that matter) requires research and testing, etc., and manufacturers need to recoup that money spent. Plus, profits from a block-buster drug go into funding expensive research on drugs that can only target a very small portion of the population. However, making tiny changes to an existing drug and calling it "new" sucks, unless the change actually has an effect on how the drug works or reduces a side-effect.
Having said all that, maybe there should be a patent peer review board (or, in government speak, the PPRB) that reviews the validity of a patent request. Maybe patents should be harder to get and you should really have to prove your stuff is unique. After some of the vague, hand-waving tech patents, I've read, it's obvious that the guys in the government reviewing these things don't have a clue.
Re: Something different? (Score:5, Informative)
Actually (according to various news outlets over the past several years), these companies spend ten dollars on marketing for every dollar they spend on research.
Claritin vs. Clarinex (Score:5, Informative)
Enter Clarinex, which Schering claims is certified for both indoor and outdoor allergies. Once again, it's a prescription-only medication with high prices. The punch line: Clarinex is exactly the same drug as Claritin after Claritin passes through your liver once. There are tons of examples like this, where drug companies change the chemical formulation only slightly, usually in inactive places of the molecule (i.e. the "business end" that interacts with the target enzymes is unchanged). Why new formulations like this are granted patents is beyond me.
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So, other than not being the same, it's the same? Regardless... how does your example back up the notion that the people who invest the up-front millions in new drugs should have less protection (in the form of a patent)? How will reducing their ability to recoup their investment cause them to produce more innovative drugs? Big innovation (as opposed to incremental changes in products) costs more money. Chipping a
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Patents protect the innovators from having every vulture on the block swoop in, reverse engineer their product and manufacture and sell it as their own.
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It's good that you put that in quotes, since part of the competition (in real life) is the competition to raise the capital to embark on creating drugs. It's fantastically expensive. So, when another company can simply start making a drug you researched and tested, without having to invest the time and millions of dollars like you did, that's hardly competition. The patent allows you to make the process worth the risk.
Pharmaceutical patents are a bad idea (Score:5, Interesting)
For example, in a recent press release [accessmed-msf.org] they write:
By allowing the pharmaceutical companies to keep their prices artificially high, the patent system kills people every day, particularly in third world countries. And it's completely unnecessary.The standard argument for allowing the pharma companies to charge whatever they want for patented drugs, is that they spend the excess revenues on research for new drugs. But that is not true.
We can look at the numbers for Novartis [novartis.com], Pfizer [pfizer.com] or AstraZeneca [astrazeneca.com].
They all spend around 15% of their revenues on research. The number is typical for the industry. The other 85% go to other things, according to their own figures. More than half their revenues are spent on marketing an profits.
So there are clearly better ways to finance drug research than to hand out patent monopolies to the big pharma companies, and hope that they will spend the money they make on research. Because clearly, they don't.
The Swedish Pirate Party has one proposal for an alternative system [piratpartiet.se]. Many others have suggested other alternatives.
But at least it is time for us to start discussing the problem in earnest. Today's situation is expensive, wasteful and completely immoral. There must be a better way.
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Granted, that may seem offensive to some people because its basically saying that the value of human life isn't universal. I'm not actually taking this position, just playing devil's advocate here.
Really, AIDS drugs are a poor example because non
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Re: Claritin vs. Clarinex (Score:4, Interesting)
> Enter Clarinex, which Schering claims is certified for both indoor and outdoor allergies. Once again, it's a prescription-only medication with high prices. The punch line: Clarinex is exactly the same drug as Claritin after Claritin passes through your liver once.
And even if Clarinex were better, they'd have no reason to release it until the Claritin patent expired. In fact, they'd have good reason not to release it.
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Any why is that viewed as a problem with the patent system?
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Its at least partially the consumers fault (Score:5, Insightful)
My company offers a generous healthcare plan for this day and age. But they ask all of us to do our best to keep costs down. I can't tell you the number of times I requested a generic from my awful dermatologist when I didn't even know one existed, only to find out that it did...and wasn't the automatic first choice! Most people aren't concerned with those costs since the insurance pays for it...but we've seen what that attitude has caused, insurance is more expensive and less people have it.
I personally don't think HSA and the like are the solution. But I can understand why they are being tried. Consumers need to be more proactive about doing their part to keep insurance costs down.
We don't need many new drugs (Score:4, Insightful)
Frankly, I avoid the use of drugs whenever and wherever possible. I find that addressing the cause rather than the symptoms is a better approach -- at least for simple stuff. I'm not a medical professional, but I (and many other slashdotters I have noticed) find that better health can be had by eliminating stuff from the body rather than by adding foreign substances.
People often have some weird ideas when it comes to medicines. TV commercials don't help much when they draw diagrams of something taken in the mouth somehow routing around the digestive tract and directly to the troubled area. The only drugs I can think of off he top of my head that behave that way are topical cremes and ointments and suppositories. Beyond that, people seem to expect often magical properties from "modern medicine." It ain't happening.
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Patents == bad, or Crappy Patents == bad? (Score:3, Insightful)
Sounds to me like its the ability to get a patent on something that's essentially already out there in the market that is stifling innovation. This sounds a lot, to me at least, like the general distaste for 'junk patents' in the software/computer industry. Perhaps if we start requiring inventions to be unique before we allow patents on them, we'll actually start encouraging bolder, newer ideas again?
A FAR more serious problem... (Score:5, Insightful)
The invisible hand of the marketplace skews development toward drugs that must be taken forever, such as blood pressure medication, or cholesterol lowering medication, or anti-depressives and so forth. These drugs are godsends if you need them, but the fact remains that drugs that actually save lives, with a small number of doses, are less profitable than drugs that merely improve or prolong them, and need to be taken continuously and repeatedly forever.
It is this warped incentive that needs to be fixed.
The antibiotics we have are losing effectiveness. Hospital infections are becoming more and more dangerous. My generation is probably going to be the only generation in human history to live its life mostly free of the mortal fear of dying from bacterial infection. There are virtually no new antibiotics in development.
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It is easy to point a finger at some issue like you describe, anybody can do that. But the question is HOW. A drug company is first and foremost a commercial enterprise. It would be silly for such an organization to pursue development of drugs like antibiotics and vaccines that bring all of the long and expensive developmnet and testing process with them, along with the legal liabilities, and then return no money.
Unltimately a lot of this situation is due t
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The antibiotics we have are losing effectiveness. Hospital infections are becoming more and more dangerous. My generation is probably going to be the only generation in human history to live its life mostly free of the mortal fear of dying from bacterial infection. There are virtually no new antibiotics in development.
It's true that anti-biotic resistant bacteria are one of the greatest modern threats to the human species. However, it's unlikely that this generation will be the last generation with the capability to effectively combat most bacterial infections. Bacteria adapt frighteningly fast to new threats, and in terms of evolutionary adaptability, they're top of their game; but humanity simply isn't playing by the same rules any more. Bacteria combat anti-biotics and immune system defences via an evolutionary feed
Re:A FAR more serious problem... (Score:4, Insightful)
No, the quite visible hand of the government skews the development towards drugs that must be taken forever. When it costs nearly a billion dollars to get a drug approved by the FDA, when the liability for approved drugs can stretch into the multiple billions, and when only huge pharma companies are the ones able to meet the astronomical costs imposed by government regulation and insane liability requirements, this kind of thing is inevitable. The barriers of entry to the market are held so artificially high by obscene regulation, that there is just no way anyone can make a profit on developing cheap drugs.
The free market had no problem producing low-profit drugs, such as vaccines and antibiotics, back when there were tens of thousands of independent research companies, and the barrier to the market was extremely small. (Antibiotics, to give an example, would NOT be approved as a class of drugs under todays regulatory scheme. They are grandfathered in.)
The FDA was created under the Pure Food and Drug Act... it's purpose was to make sure that the product that companies were selling were the product that they said they were selling. It was supposed to stop people from outright lying about the substances that put into drugs, it wasn't supposed to evaluate and micromanage every single detail of drug development. It was supposed to make sure when a company sold a bottle of aspirin, that it was in fact aspirin and not sugar pills... it wasn't supposed to evaluate the effectivness and safety of the aspirin - that was left to the medical community to evaluate and decide for themselves.
The FDA is no longer making us safe... its job now is to make drug development as expensive as possible so that only a handful of companies can afford to develop drugs. Big Pharma is the direct result of Big Government. If you create regulations that make drug development contigent on have vast pools of capital, then only those with vast pools of capital, and who can agressively secure more capital, can survive in the market place.
analogous to Open Source .. (Score:5, Insightful)
It's also difficult to avoid infringing some patent as the GM crops cross-fertilise with plants in the next field. The resultant seed being also covered by the same patent. The GM companies would of course have the farmers buying their seed annually from the companies. What next, produce sterile crops and totally outlaw unlicensed seeds.
As the report says in relation to pharmaceuticals, you can see the same thing in the closed Windows monopoly, little real innovation, "new" software that is differs little from the old and a small number of companies making vast fortunes and lastly it's the consumer that suffers from no real choice.
Seed growers already have protection (Score:2)
On the other hand, the farmers themselves still have the demand for better/different cultivars, so abolishing these breeders rights will not undermine the driving force of the breeders market, and the traditional breed
its a pickle alright (Score:2)
wait... that doesn't sound very moral to me
Your a Pickle all Right! (Score:2, Interesting)
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Sounds familiar (Score:2, Funny)
I can think of one example in the software industry where this easily applies.
Thank You For Me-Too Drugs (Score:5, Interesting)
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Link to the report, plus, get them for free (Score:4, Informative)
GAO Junkie
It is not that simple (Score:2)
This is why we should ban advertising (Score:5, Insightful)
If we really want to see new drugs AND get cheaper health care, banning advertisements is a good start.
Re: This is why we should ban advertising (Score:3, Informative)
And it used to be banned in the USA, until "someone" bought enough congressmen to get that reversed.
(Same with the ambulance chasers that you mentioned in passing.)
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Doctors should be nothing more than a highly recommended consultant. They should not be the gateway to what you are allowed to put inside of your own body. Just about every doctor has the "I went to 6+ years of school, so I know what is good for you" mentality. If they were so god damn sure of themselves they wouldn't need so much insuran
IP always IMPEDES innovation (Score:2)
I'm confused why this matters (Score:2)
It is certainly believable that drug companies will patent minor changes to drugs to gain more protection, but I don't quite see how that stiffles competition. Consider a drug company that makes a genuinely new drug, labelled A, and patents it. A little while later, they also patent a slight variant on the drug, call it B.
17 years(?) later, the patent on drug A expires and anyone who wants to can create copies. The patent on the "me too" drugs are still in effect, but does that matter? As long as I on
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The point is that under the current system there's a greater capital return on the former approach, and so the capital is invested in small incremental improvements, and less is available for the groundbreaking (and high risk) research.
No surprise (Score:3, Insightful)
A few things I noticeded.
1) Lots of patents cover minor improvements of existing drugs.
2) Lots new drugs are similar to existing drugs.
3) Patents are such a wonderfully effective mechanism that regulators (the FDA etc) have to give pharmas additional incentives (such as orphan drug deisgnation) to develop certain drugs.
4) Patents do more to boost marketing expenditure than R & D expenditure.
There is also no real evidence of what effect patents have. We know from academic studies that they have little positive impact on semiconductors or software, as for eveything else, we have no idea.
Shaky Conclusions (Score:2)
Drug patents have existed for over a century, during this period of time there have been great waves of introduction of useful medicines, al
Patents only seem to encourage... (Score:2)
Pharmaceutical Business Model (Score:2)
See the difference?
They milk more out of insurance/consumers by perpetuating the disease.
It is universally acknowledged that the primary cause for the rise of medical costs is drug patents and the high cost of drugs. While efforts have been attempted to correct this, the pharmaceuticals are firmly infiltrated in government and lobbying such that little progress has been made.
O
6 months from now (Score:2)
Random Thought (Score:3, Insightful)
Just thinking out loud
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Re: Another questionable study (Score:2)
a) The problem has already been known for about a decade.
b) The Demoncrats don't pwn the GAO.
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