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Report Says Patents Prevent New Drugs 381

Posted by samzenpus
from the but-the-old-ones-were-good dept.
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.""
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Report Says Patents Prevent New Drugs

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  • Exaggeration (Score:5, Insightful)

    by Petronius.Scribe (1020097) on Thursday December 21, 2006 @09:06AM (#17323826) Homepage
    The headline draws rather a long bow. I think that what's clear from this report is that the current patent system is broken and stifling innovation. However, this does not invalidate the very concept of a patent, which the article summary suggests is the case. "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" - this is still true. It's the current implementation of the "profitable monopoly" that is causing issues.
  • by PingSpike (947548) on Thursday December 21, 2006 @09:13AM (#17323886)
    If the drug companies can get away with sticking a capital letter on the end of an existing drug while changing its dosage to get a new patent, thats certainly an issue with the patent system. But its only one element in a perfect storm in this case. If consumers weren't so brand horny, and were more cost oriented when buying their drugs then these drugs wouldn't even sell. Few of them offer any signifigant benefit, and I'd argue none have any benefits worth the extra cost. But consumers see that 'D' or some other moniker advertised and assume thats the new one with less side effects that they need to demand from their doctor while asking for antibiotics to treat their viral infections. For health care providers part though, its their job to recommend drugs to their patients...and since a lot of them seem to be getting a kickback from the drug companies, they don't always make the the correct decisions.

    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.
  • Re:Exaggeration (Score:5, Insightful)

    by Anonymous Coward on Thursday December 21, 2006 @09:20AM (#17323926)
    MMM symantics,

    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.
  • by erroneus (253617) on Thursday December 21, 2006 @09:23AM (#17323940) Homepage
    Many of these "newer drugs" are simply older drugs with some manipulation...patented manipulation.

    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.
  • by bsmoor01 (150458) <seth@beeERDOSre.org minus math_god> on Thursday December 21, 2006 @09:26AM (#17323960)
    From TFA: "the ability of drug manufacturers to easily obtain patents for minor changes to products, or to receive patent exclusivity for new uses of existing products, have reduced incentives to develop new drugs."

    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?
  • Re:Exaggeration (Score:5, Insightful)

    by Qzukk (229616) on Thursday December 21, 2006 @09:28AM (#17323968) Journal
    The problem is that the patent system allows one to "upgrade" a patent without revisiting the question of "now that you've told everyone how to do X, is X+1 really all that novel and non-obvious?"
  • by dpbsmith (263124) on Thursday December 21, 2006 @09:29AM (#17323978) Homepage
    ...is that profits are much lower for drug products, such as vaccines and antibiotics that are extremely effective and "cure" in a small number of doses, than for drugs products that merely help, or palliate.

    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.
  • by rs232 (849320) on Thursday December 21, 2006 @09:30AM (#17323980)
    The pharmaceutical industry is where the software industry would be if it wasn't for the existence of Open Source. That the closed source companies are pushing for a US style patent regime in Europe and elsewhere is a given. What with patented GM crops we see farmers being sued in the US for reusing GM seeds grown from their own crops. Something practiced for centuries.

    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.
  • by Gr8Apes (679165) on Thursday December 21, 2006 @09:37AM (#17324020)
    To reject any application that can't explain in plain english and 2 sentences (120 words) or less why it is unique and deserving of a patent.

    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.

  • Re:Exaggeration (Score:5, Insightful)

    by rahlquist (558509) on Thursday December 21, 2006 @09:51AM (#17324140) Homepage
    Agreed, and another problem with that is the change has only to be minimal even as little as changing the purpose and/or dosage of a drug. While I can understand the reluctance of the industry to invest say what $100 million in developing a new drug, at the same time this lack of drive is caused by the patent system.

    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.
  • by shaneh0 (624603) on Thursday December 21, 2006 @09:57AM (#17324180)
    I say that we should just scrap the whole thing and go back to the days of the traveling snake-oil salesmen. God knows that was much better for consumers.

    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--impressive than in any other industry. Maybe they could be better under different circumstances, but I'm absolutely sure that they could be worse.

    The grim truth is that we still only have rudimentary understanding of our own biology. The only reliable way that we've found to test drugs (and drug interactions) is by lots and lots of human trials in graduating size and complexity. How else are you going to know what drug X does when it's mixed with drugs Y & Z on a patient that used to take drugs C, D, and F and once suffered from diseases J and K?

    Even now--with this rigorous testing--we find that some drugs should never have been sold. Vioxx comes to mind. These episodes are famous because they're so rare and they shake consumer confidence in the pharma industry. Imagine what it would be like if that were a weekly or monthly occurrence.
  • Re:Exaggeration (Score:3, Insightful)

    by mwvdlee (775178) on Thursday December 21, 2006 @10:05AM (#17324280) Homepage
    The problem isn't so much the existence of patents but rather the frivolous "inventions" that are currently being patented. There needs to be a higher bar for patent acceptance. If somebody invents something truely unique (of the kind which doesn't combine currently available material in a straightforward way), it should be patentable.

    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" patent which could be licensed for a sum of money proportionate to the quality of the invention and the age of it. At the very least the duration of patent protection should be based on the use of that actual patent; if products implementing (and not varations) a specific patent is no longer actively sold (people actually paying money for the product) by the inventor, it should end.
  • Re:Exaggeration (Score:4, Insightful)

    by hey! (33014) on Thursday December 21, 2006 @10:07AM (#17324288) Homepage Journal

    It's the current implementation of the "profitable monopoly" that is causing issues.


    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.

  • by antifoidulus (807088) on Thursday December 21, 2006 @10:12AM (#17324344) Homepage Journal
    You know what the nicest thing about Japanese and German television is compared to American TV? It isn't what you see(TV is pretty dumb the world over), but more of what you don't see. No ads for prescription drugs for starters(no ads for ambulance chasers either, but that is a different story). The reason drug companies patent drugs that vary little from existing drugs is because they can still make money off of them by advertising them both to patients and to doctors. Patients go in and demand the name brand of the drug they saw on TV(which further feeds into the trend of self-diagnosis, but that is another rant) and doctors who are required to get a certain amount of education every few years enroll in drug company sponsored classes. They turn a well meaning law into profit for drug companies.

    If we really want to see new drugs AND get cheaper health care, banning advertisements is a good start.
  • by shaneh0 (624603) on Thursday December 21, 2006 @10:22AM (#17324442)
    If it wasn't rare you wouldn't remember it when it happens.

    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. Simple logic tells me that it probably was, at least some of the time.

  • by Anonymous Coward on Thursday December 21, 2006 @10:24AM (#17324460)
    There is really a main part of the patent system. Encouraging innovation is just a side effect. The idea is that without patents there are a few outcomes.
    1) Companies would keep their "trade secret" forever, if the person who knew it died in an unfortunate plane accident with the plans in his briefcase there would go the life saving drug.
        A Patent gives the company incentive to reveal their secret and at the same time are protected for some time it's an exchange.

    2) Competition (such as in the early part of the industrial revolution) would hire employees of said company to steal the trade secret, since there is no legal protection, and it would be very hard to prove this type of theft. The patent system creates a legal system were people file their inventions and are protected from this behavior.

    The vast majority of research in drugs or is done at the medical school level, where they have people paying for the privilege of doing research. Pharmaceutical companies are partnered with them to get that research (funded by governments in many countries). It wasn't until the 1990s that collages were allowed to patent research paid for by public money, so in many cases they gave their work to companies that then got the patent on this research paid for by the public.

    This has changed and now many universities hold a significant patent portfolio when it comes to drugs and drug research. In addition there are huge government grants to fund research for drugs that will have limited or no ability to make a profit during the life of a patent.

    The other major issue is liability, drug companies don't want to be sued, so its better for a big name to create a spin off company that can do the research on very new drugs that way if any issues come up (big lawsuit) then they can fold that company, and then reap the profits with a new warning label.

    The bottom line is that its not just patents, its a whole string of problems that exist with the system, and no one who has the ability to change things is really interested in doing anything. If there were no patents, we would quickly see the only drug these companies put out would be safe ones that they are sure will sell allot of.

  • No surprise (Score:3, Insightful)

    by the_womble (580291) on Thursday December 21, 2006 @10:29AM (#17324514) Homepage Journal
    I sued to be an analyst at a fund managemetnt company. I used to look at pharmas (although I was not a sector specialist).

    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.
  • Re:Exaggeration (Score:5, Insightful)

    by UbuntuDupe (970646) * on Thursday December 21, 2006 @10:32AM (#17324544) Journal
    Without patents, patent-heavy fields like pharmaceutical research fall into cutthroat, razor-thin-margin price wars - but that is not a bad thing.

    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.
  • Re:Exaggeration (Score:2, Insightful)

    by Nappa48 (1041188) on Thursday December 21, 2006 @10:39AM (#17324600)
    This Anon has it nailed already. The whole medical world screws us over because curing is bad for their business. Someone creates a cure and they are probably frowned upon. Or in another twisted up scenario, they already have cures for most diseases...and just release them at certain times when they can predict what will happen when its released. T'is a horrible fucked up world we live in... driven by greed, regardless of what it is.
  • Re:Exaggeration (Score:5, Insightful)

    by blakestah (91866) <blakestah@gmail.com> on Thursday December 21, 2006 @10:47AM (#17324668) Homepage
    That's just not true. Polio, smallpox, almost wiped off the earth. HIV infection has been made manageable, and people are working very hard on vaccines.

    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.

  • Re:Exaggeration (Score:5, Insightful)

    by kripkenstein (913150) on Thursday December 21, 2006 @10:55AM (#17324734) Homepage
    *Cures* are not good for business [...] And this i find truly disturbing.

    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.
  • Re:Exaggeration (Score:3, Insightful)

    by XxtraLarGe (551297) on Thursday December 21, 2006 @11:01AM (#17324796) Journal
    What's next? "Strawberry Drug X Gel Capsule with GLITTER ... better than before!!!" The problem there is the retards at the patent office enable this type of thing to happen. Naturally, the drug companies are going to exploit the situation. I can't believe that they're that incompetent. If they aren't idiots, then I'm sure there are some pockets being lined at the USPTO.
  • Re:More like: (Score:3, Insightful)

    by westlake (615356) on Thursday December 21, 2006 @11:10AM (#17324896)
    With the kind of laws regulating this industry, you wouldn't even be able to research *aspirin* today, let alone have it approved or sold.

    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 potent than the gin mill's rot-gut whiskey didn't matter. that it promised cures for everything from tuberculosis to cancer didn't matter.

    american medicine was quack medicine.

    the real, meaningful, advances in pharmaceuticals were coming from abroad.

  • Re:Exaggeration (Score:3, Insightful)

    by mysticgoat (582871) * on Thursday December 21, 2006 @11:11AM (#17324914) Homepage Journal

    It's the current implementation of the "profitable monopoly" that is causing issues.

    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.

    [later] Patents are an artifice.

    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 times: money? I'm thinking of a patent oversight board similar to the US Federal Reserve Board.

    If length of patent life and degree of rigor in the qualifying process were adjustable at any time by an independent Patent Oversight Board, everything would change. There would be an immediate decrease in the number of "frivolous" patent applications from big corporations, since the act of applying for a patent on blue widgets might adversely affect the expected profits from their existing portfolio. Even before the POB issued its first decisions, the pharma and software industries would begin a process of self-regulation that could be steered toward a general increase in real innovation.

    An example might make this clear: if the POB said that it was considering reducing the length of life of all patents by 6 months to control the volume of new patent applications, and would consider further downward reductions if this adjustment was insufficient, the big pharmas and software houses would definitely reduce the numbers of patents they apply for to protect the profits from their existing holdings. If the POB said that for the next 5 years patent applications on drugs and treatments for cystic fibrosis would be expedited by using a less rigorous qualifying process, that could well spur research into CF.

    Why would a POB not work? The FRB works well enough for managing the economy of money; why not use the same technique to manage the economy of new ideas?

  • by MindStalker (22827) <mindstalker@gma[ ]com ['il.' in gap]> on Thursday December 21, 2006 @11:24AM (#17325058) Journal
    You also have to consider the fact that the patents are an encouragement to sit on a drug that has already been developed and wait till the patent expires before releasing newer potentially better versions. The newer versions would come out faster and more often if the patent didn't last as long. Either way arguing that INCREASING monopoly powers is a good thing economically is silly.
  • by that_xmas (707449) on Thursday December 21, 2006 @11:31AM (#17325136) Homepage
    The incentive to produce the slightly different drugs all comes down to the cost of bringing drugs to market. In 2001, it cost $802 million to bring a drug to market in the US. [tufts.edu] Only around 20 percent of drugs make it to past Phase I testing. Patents are usually taken out when a drug reaches that early phase of testing, and the testing can take upto 8 years, [healthcare-economist.com] leaving only 12 years for patent-protected sales.

    I can't find a link for it, but I believe that the patent office has already changed it's policies of drug patents to prevent minor changes being repatented as brand new drugs. That still means that the original formula of the drug is no longer under patent.

  • by AdamKG (1004604) <slashdotNO@SPAMadamgomaa.com> on Thursday December 21, 2006 @11:38AM (#17325218) Homepage
    It is fantastically expensive. But that doesn't mean it wouldn't be done. There are huge rewards to be made when you have the ability to cure someone's disease; people will pay early, often, and lots for treatment, and companies will always rush to fill that gap, patents or no. If the innovating company does its job right, they deploy their product before the competition has a chance to copy the product. And if its not doing the job right, and the competition does copy and undersell the innovating company, then that company will go out of business, to be replaced by companies that can innovate and deploy to everyone quickly and efficiently, which is what we want in the first place. Patents merely reward having inefficient, slow rollouts- and especially reward slow rollouts that deliberately do not meet demand.

    A pharmaceutical business climate based on first-to-market will have the added benefit of biasing companies towards developing medicines that are complete cures, and not treatments that take years or decades- the opposite of the current bias. It's currently a far worse business decision to conduct research in extremely aggressive leukemia, versus making the next Viagra. That shouldn't be.
  • by shaneh0 (624603) on Thursday December 21, 2006 @11:50AM (#17325334)
    "a private industry would be faster, better and cheaper."

    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.
  • Re:Exaggeration (Score:1, Insightful)

    by Anonymous Coward on Thursday December 21, 2006 @11:53AM (#17325384)
    "And if you're unhappy with the high cost of drugs (or medical care), don't buy them and see how well you do."

    And if you're unhappy with the "protection" you're getting from the Mafia, just don't pay it, and see how well your business does.
  • Re:Exaggeration (Score:4, Insightful)

    by radtea (464814) on Thursday December 21, 2006 @12:27PM (#17325770)
    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.

    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.
  • by rhombic (140326) on Thursday December 21, 2006 @12:54PM (#17326088)
    I am so ridiculously tired of hearing this absolute BULLSHIT. I'm a researcher at a pharmaceutical company. Most of the conditions we're trying to make drugs to already have a cure: Put down the cheeseburger, put down the mountain dew, get your fat lazy ass off of the couch and get the fuck outside and walk around a little. There is no cure for a retard eating 4000 calories per day with 15g of saturated fat-- you are going to get type II diabetes and atherosclerosis. That's how your body works. And the way the biochemistry works, THERE IS NO CURE. The systems are working exactly the way they're supposed to. Problem is, they've evolved to store fat during the rare times of plenty, and then dole that out during lean times.

    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.

  • Re:Exaggeration (Score:1, Insightful)

    by Anonymous Coward on Thursday December 21, 2006 @12:55PM (#17326092)
    Just my 2 pennies,

    One thing I realized with the last few years "medicine scares" is how drug companies will create a drug similar to an existing one, with no innovation or advantage to society.

    Scenario: You have Company A that made "A-ox" 20 years ago, and works well for 90% of the population, meaning with no side effects. The other 10% might get headaches. Company A makes a lot of profit off it (a lot).

    Company B sees the profit, so creates "B-ox", a drug with the exact same role, but works well for only 60% of the population. The other 40% get side effects that are not too bad, headaches, sleepiness, some rare occurrence of incontinence. And one in a very rare case low blood pressure that might cause death to people with existing heart condition.

    Deaths are so rare, around once every 1 Million, that it does not even show in human trials, since they include a "small" 30 thousand people.

    Follows a huge marketing campaign, including plenty of free sample, paid trips to conventions, bla bla bla, all translating in hidden payolas. Doctors everywhere stop prescribing A-ox, but instead sell B-ox. Shareholders of B are happy and see the money train ongoing for the next 60 years of patent holding.

    The campaign is so successful, 3 years later 750 Millions prescriptions in the world make the "Extremely rare cases" to 750 deaths.

    All deaths avoided if we would have stick to "A-ox".
  • by shaneh0 (624603) on Thursday December 21, 2006 @01:15PM (#17326326)
    I think you really miss a lot of important points with this idea.

    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.
  • by RexRhino (769423) on Thursday December 21, 2006 @01:21PM (#17326402)
    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.

    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.
  • Re:Exaggeration (Score:3, Insightful)

    by rucs_hack (784150) on Thursday December 21, 2006 @01:22PM (#17326412)
    In fact cures *are* good for business, but they are staggeringly hard to create.

    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. The problem is that no-one knows which compound within Garlic is responsible, and most sticking the whole lot in someones bloodstream would kill them as well, in a rather horrible fashion. Just eating it has no effect. It would cost so much to discover which compound, or combinations of compounds is responsible that it's most likely easier not to bother and to try another, easier route (where easier is still bloody hard).

    Nature's larder is full of things like this. The problem, by and large, is not finding things to kill disease, it's finding things that don't kill the person along with the disease.
  • Random Thought (Score:3, Insightful)

    by localman (111171) on Thursday December 21, 2006 @02:52PM (#17327586) Homepage
    What if patents only allowed the bearer to hold the patent as long as it took to cover their R&D costs? So if I come up with a clever idea which I can implement overnight (like one click shopping) I get basically no protection. But if I spend a million dollars working out a flying car or a new cancer drug, I am covered by the patent until I recoup my losses, then it's fair game. It could be "recoup losses + 10% too" or something.

    Just thinking out loud :)
  • Re:Exaggeration (Score:4, Insightful)

    by jafac (1449) on Thursday December 21, 2006 @05:19PM (#17329880) Homepage
    I realize that most socialists, it is just implicit and assumed that government is good, everything else is bad, and so the question answers itself.

    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= a8vosisrgmd0 [bloomberg.com]

    The individuals who will not be served by this system, will be in no position to effectively fix it (as is the case today).
  • by rc5-ray (224544) on Thursday December 21, 2006 @11:26PM (#17333346)
    Okay, your response is that of the pharmaceutical researcher. My response is that of a family doctor:

    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, and ethical reasons to motivate you to find a new treatment for major diseases. Good for you. (that's not sarcasm-I really mean that).

    However, the marketing and PR departments and the army of drug reps out there present a different perspective. There's not a day that goes by that a drug rep doesn't try to convince me that I should be prescribing Diovan/Cozaar/Benicar/Micardis, etc., for blood pressure instead of Lisinopril. Diovan and friends are a class of drugs called ARBs that have are very effective for lowering blood pressure and thereby lowering the risk of stroke and renal damage. However, Lisinopril, belonging to an older class of drugs called ACE inhibitors, is just as effective, and it's dirt cheap. The irony is that Lisinopril was once marketed like crazy as THE go-to drug for hypertension. But once it's off patent and generics are available, you never hear about it again. The implication is that if I want to be an up-to-date physician, I'd be prescribing the latest and greatest. Never mind that it doesn't work any better.

    The most recent, blatant, insulting example was Zocor. For years, Zocor was pushed as god's gift to lowering cholesterol. And yes, it has some great studies showing decreases in heart attacks. However, Zocor became available as a generic this year. I had two visits from the SAME Merck rep about 3 months apart. At the first visit, the message was, "Zocor. The drug of choice. Blah, blah, blah. Nothing new here."

    At the second visit by the exact same rep, she tells me, "Well, you might use Zocor for your patients who need mild cholesterol lowering. But for patients needing robust lowering, you really should avoid Zocor and prescribe VYTORIN (trumpets sound in the background). Coincidentally, Vytorin is simply Zocor plus Zetia combined into one pill. Wow!! That's some great innovation there! At least the stockholders would see it that way.

    This happens again and again with me-too drugs. Claritin and Clarinex? Floxin and Levaquin? Prilosec and Nexium? Celexa and Lexapro? Albuterol and Xoponex? The second is simply one isomer of the first, which is a racemic mixture. These drugs are already invented and patented. Why should separating a racemic mixture justify a new patent? It's absurd. It may be technically challenging, but not patent-worthy.

    As for the HPV vaccine: it's a great shot series, but Merck isn't selling it cheap. I understand that they've got to cover R&D costs, but if they were as altruistic as they'd have us believe, they'd be giving it out as cheaply as possible.

    Perhaps if the NIH were probably funded and could support large, ongoing studies, we'd see some real breakthoughs in new drugs. As long as pharmaceutical companies foot the bill, they will always take the easier route of slightly modifying an existing drug, re-patenting (is that a word?) the "new" drug, and selling it just barely below the current market leader. They may stumble onto new, innovative compounds that are actually a breakthrough, but as the article points out, this is the exception, not the rule.

Facts are stubborn, but statistics are more pliable.

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