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Patents

Patents Choking Off Medical Research 278

pq writes "The New Republic has an insightful article talking about the "absence of truly innovative drugs in current drug company pipelines. And the explanation for that might well come from the supposed fount of American innovation: our patent system." Apparently they are trapped in a situation where "it's much easier to argue that `patents support innovation' than to try to explain that some patents are good for innovation while others are bad." A long read, but unlike the latest copy-protected mp3 player, this is definitely stuff that matters!"
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Patents Choking Off Medical Research

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  • by elefantstn ( 195873 ) on Wednesday October 02, 2002 @02:26PM (#4375237)
    The linked article claims that medical research is being harmed by the patent system, but then provides no concrete evidence to prove this is so. The closest it gets is an assertion that there are fewer new meds being produced -- with the laughable backup of "watch commercials on TV, you'll see!" -- without any exploration whatsoever of possible other factors.

    Was there a point to posting this on Slashdot, or are we just trying to jump on an easy-to-blame bogeyman?
    • by SirSlud ( 67381 ) on Wednesday October 02, 2002 @02:50PM (#4375436) Homepage
      It's a difficult thing to prove quantitatively (although the market woes and the lack of any new groundbreaker like Viagra and Prozac in the pipeline is mentioned .. did you want that in a pie chart?) .. especially since the questions of what drugs are important, which arn't, whether some drugs are actually better than the problem they cure .. these are not neccessarily quantifiable things.

      The thing is, most of the people I know in the scienitific community right now agree with that main charge of this article. Yes, patents are important, but there is a crowing concensus that simply allowing anything and everything to be patented (which is increasingly the case) harms the very industry that patents were put in place to support.

      We've become so engrossed in the battle for the pie that we ruined the pie for everybody in the first place. There's plenty to share, so we shouldn't focus so hard on ensuring that yoou'll get your pie. Or in another analogy, if capitalism is people in competition to the finish line, we've gotten so good at tripping each other up and not actually runny that we might as well have all walked the distance.

      Yes, there is no quantitative proof, but the way the industry operates, you'd have to wait 5 or 10 years to see the effects that the current research climate has on the consumer end of the industry. So, we have to rely on people in-the-know to identify problems and solutions before we can tally them on a spread sheet.
      • We've become so engrossed in the battle for the pie that we ruined the pie for everybody in the first place. There's plenty to share, so we shouldn't focus so hard on ensuring that yoou'll get your pie. Or in another analogy, if capitalism is people in competition to the finish line, we've gotten so good at tripping each other up and not actually runny that we might as well have all walked the distance.


        That's total bullshit and you know it. Which drug companies are tripping the others up? Are the Merck people sending spies to Pfizer to poison their samples?

        Listen to yourself, dude, you're just babbling.
        • by SirSlud ( 67381 ) on Wednesday October 02, 2002 @03:15PM (#4375622) Homepage
          >Which drug companies are tripping the others up?

          s/tripping/patent-litgation

          So, effectively, you're saying this entire article is BS. Which I assume means that you believe that the actual granting, defence, and enforcement of patents can only be good, regardless of the situation, whats be patented, whos patenting it. It can only help humanity, right? All patents. More patents! More!

          No .. there comes a time when you're spending so many resources on trying to be competative other than the actual market fitness of your product that you sacrifice the over-all quality of the product being produced. One example: My father, being a principal R&D guy at a pharmaceutical technology company, was involved in patent litigation that delayed the development of a product they were working on. You simply cannot assume that the cost of not enforcing their patent ALWAYS outweigh the costs involved in filing it, defending it, nor preventing other companies from building off of it. You can't predict the future, either, which means that theres no way to actually prove that had you not filed/enforced a patent, you wouldn't be better off for it.

          Tripping each other up doesn't imply illigal action, it implies exactly what the article implies .. some patents are getting in the way of the very goal (to create better drugs) they are supposed to encourage. I have never met anybody in science who doesn't recognize that you can have too much of a good thing when it comes to patents. So then its just a matter of, like I said, figuring out the point where people are spending more time/money trying to defend what they have instead of using that time and money to do what they are chartered to do.
    • by Dannon ( 142147 ) on Wednesday October 02, 2002 @02:57PM (#4375485) Journal
      I tend to agree. There isn't a new arguement here, and none of them hold water.

      A good bit of what I read was a poke at the prices of new drugs, and a drop in investment. Well, new drugs are expensive to produce and test thoroughly. There's the expensive research to find a new treatment. Then, there's the expensive and extensive government-mandated testing to make sure the drugs won't do more harm than healing. After that, before the drug can be marketed, it has to be patented... which means telling everyone else how to make it.

      And there's only a short time period for the research company to recoup its expenses before the 'generic' drug companies are allowed enter the market... to produce the same drug, without all the R&D costs. If it's an extremely useful drug, you'll hear of people lobbying the government to let the generics start early, cutting in on that short time period the patent-holder has to recoup losses and make enough money to satisfy the investors. And now, you've got more folks wanting the government to step in again and engage in more price-fixing for drugs used by retirees.

      Whenever the government limits the odds of receiving return on one's investment, investment will drop. And that applies to the investments of time and effort by drug researchers as well as the financial investments from Wall Street.
      • by nachoworld ( 232276 ) on Wednesday October 02, 2002 @04:00PM (#4376026) Homepage
        Drug companies have 20 years from the filing of patent to have exclusive rights to the drug. After going through NDA and FDA approvals the average drug gets 7 years on the market. Meanwhile, hundreds of millions of dollars are needed to be recovered in 7 years.

        If we combine the effects of foreign governments not allowing US based companies to charge for "R&D costs" (they allow a small amount of profit), US citizens usually get a bum deal in terms of name brand drugs. US residents are accustomed to paying high prices. That is why the main R&D center of the largest British pharmaceutical company is located near Philly.

        Luckily this summer, the Senate passed the Schumer-McCain bill that helps boost access to generics and boosts competition. The traditionally self-competing and bickering major generic manufacturers also have formed a pharmaceutical association in a similar vein as the major pharma companies.

        I am a med student who is concurrently getting an MBA in health administration. The current health care costs are 14% of our GDP (~$1.4 trillion) and drugs are the fastest increasing component of the cost.

        Please, if we are all to help force down drug prices, ask your pharmacist for generics
        • Drug companies have 20 years from the filing of patent to have exclusive rights to the drug. After going through NDA and FDA approvals the average drug gets 7 years on the market

          A question for you, which you may not know - why so long? Yes, you have to do both animal and human testing during that period, but why is it taking (on average) 13 years to do all of this? As I understand it, the standard human testing period is 1 year. I don't know about animal testing, but I'd guess it's about a year as well. Even giving an additional year to do analysis on those tests, that's only 3 years. Does all the governmental approval really eat up another decade?
    • by the gnat ( 153162 ) on Wednesday October 02, 2002 @03:09PM (#4375574)
      Read the article again. They explicitly mention hepatitis research, and Harvard suing over osteoporosis research. Then there's the suggestion that HGS may be able to interfere with AIDS research. And aside from screwing other people, Big Pharma is now trying to squeeze every little bit of life out of existing products for which it has patents (or can get bogus new ones) rather than doing actual innovation.

      This isn't *quantitative* evidence, but it doesn't sound like the author just pulled all this out of his ass. And as a biomedical researcher, I assure you there is a huge body of evidence to support the article's assertion which did not appear there.
    • Its an article, not an indepth research study. Most people will only read bite sized articles as this, and thus get a small education on the problem.

      Look at the laws being passed about drug perscription prices, the news articles on price fixing on drugs, the patents on genome. AIDs drugs waiting for FDA approval.

      Use the article for what it is, a spark to make you think and ponder.
      -
      The advertisement is the most truthful part of a newspaper. - Thomas Jefferson (1743 - 1826)
    • The article also seems to avoid discussing:

      1. the rigorous standards and testing imposed by the FDA (which are a GOOD thing, but make truly innnovative drugs much more difficult for companies to gain clearance to manufacture), and

      2. frivolous lawsuits like the current drug-dilution suit being brought against a major manufacturer. A pharmacist is accused of diluting the company's medications and thereby lining his own pockets. The company accused of compliance has no reason for it; they actually LOST profits through the pharmacist's actions. The legal eagles are going for where the big money is, but such situations waste time and resources that could be better spent on research.
  • by SirGeek ( 120712 ) <sirgeek-slashdot.mrsucko@org> on Wednesday October 02, 2002 @02:27PM (#4375246) Homepage

    When is the last time that drug companies actually came up with a cure ?

    Answer: NEVER, cures are bad for business.

    The last cures that were found (Polio, etc.) were found by independant researchers not worrying about the bottom line and how the stockholders will react)

    I mean how many bloody treatments do we need ? Find a damn cure....

    • When is the last time that drug companies actually came up with a cure

      I was just thinking about this the other week...how the vast majority that modern medicine offers simply treats the symptoms (or masks them) and does little to "solve" anything. As soon as you stop taking the medicine you're right back where you are. I know there is stuff that doesn't fit this pattern (antibiotics) but by and far medicine just doesn't cure anything.

      Now perhaps this is due to our own limitations in knowledge and understanding. I doubt it has a whole lot to do with the bottom line (ie don't cure them...keep them on medicine for a steady cash flow). I mean, if a company offered a cure and charged outrageous prices for it, I'm sure most people would pay for a permanent cure.

    • This is one of the stupidest things I've ever read on Slashdot. I mean, really, just think about it.

      AP (New York, Oct 2 2002): Stock prices for Merck Inc plunged 67% today when it was learned that it had discovered and planned on selling a cure for cancer. "How can a drug company with a cure for a widely-spread disease expect to make any profits?" said one industry analyst.
      • by aengblom ( 123492 ) on Wednesday October 02, 2002 @02:43PM (#4375383) Homepage
        No, it's right on. It's a well-known problem too.

        It's not that the drug companies are sitting on the cure.

        They're not LOOKING for it. The private money is funneled into drug possobilities that will pay off. Actually, I'm fine with this. Great, we get treatments. But government has to step up and pay the bill for research that benefits "the public good". Markets arn't the perfect solution for everything. In drug/health care, cooperatives that are put improving health above, investment returns are very important.

        Think about it. Any companies that put the amount of money towards vaccines etc that was relative to their health care value WOULD GO OUT OF BUSINESS. Why vaccines aren't profitable. They are one time use (or so). You only get so many years of monopoly anyway. People will (rightly so) riot if you charge $10,000 for a vaccine for polio, which might make it more profitable.
        • by Ralph Wiggam ( 22354 ) on Wednesday October 02, 2002 @03:03PM (#4375533) Homepage
          Actually, almost every drug company has gotten out of the vaccine business. The government is by far the largest buyer of vaccines and their budget would dictate how much they could pay. Companies couldn't make a profit selling for what the government was paying, so they just stopped doing it. Due to Wyeth-Ayerst dropping out of the tetanus vaccine market, there is almost none available in the country. Tetanus is a horrible disease that virtually nobody gets. Nobody gets it because up until now, the vaccine against it has been highly effective and rather inexpensive. That may be changing in the near future.

          I love free markets, but for certain things "the market" isn't the answer. People's health and safety need to take precedence.

          reference:
          http://archive.salon.com/tech/featur e/2001/03/08/t etanus/index.html - take the space out after you paste

          -B
          • Actually - there are a few reasons why vaccines aren't developed by many companies (though there are a few companies left which still research them).

            1. Price - you can't sell children's medication for $75 without starting a riot. And there isn't a return market - it is once and done.

            2. Liability - vaccines end up being administered to most of the industrialized population of the world. If later somebody cries "it causes autism" then you are defending yourself against almost the entire planet in a class action lawsuit - since the class is so large governments don't interfere with the suit since the majority of voters have a stake in the outcome.

            3. It isn't easy - as the article points out - most of the low hanging fruit is gone.

            I agree to a degree with some of the points the article makes - pharmaceutical companies should be encouraged to find new cures and not just out-market existing ones. Any patent reform which helps the public welfare is a good thing then. However, the profit motive to develop new medicines should be protected.
        • So why isn't there a reward system for cure research? Have people, the government, or better yet governments put up a sum of money to the person, or group of people that create a verifiable cure. Stick it into something guaranteed and let the pot grow. Would drug companies work to cure aids if there was a few trillion dollars at stake?
          • Bounty System. (Score:3, Insightful)

            You know, that may be the best idea I've heard for this in a long, long time. There exists plenty of science which is good for people but bad for business---cheap launch technology, vaccines, that sort of thing. A bounty system would make it good for business.

            Of course, you'd run into nightmarish problems with fraud and deception---with that much money on the line, it not only becomes profitable to research, it becomes profitable to cheat. You'd need an honorable, impartial judge (or panel thereof) to test the supposed cures.

            All it takes is one crazy millionaire to get the ball rolling and set up this foundation. Any takers?

            --grendel drago
          • So why isn't there a reward system for cure research?

            Complete and total trust in the market.

            Taxes suck

        • Sorry, but I work in a related industry and must disagree with your theory that a cure must be less profitable than a mere treatment.

          Firstly, it is a FACT that quite a few medication plans cost more than 10k a year. 10k up front is chump change actually. I can name quite a few medical devices that cost this much and they're all up front. So to say that people would necessarily not accept a one time treatment payment plan following a similar payment schedule would be to ignore the evidence.

          Secondly, the insurance companies who generally cover almost ALL of these kinds of treatments would look at this fact a lot more rationally. Although the the insurers may far prefer dragging payments out from a cash flow perspective, a perfect cure greater than the sum of the cost of the treatments up front could easily be highly desirable to them. (and if it's too burdensome a mutually agreeable payment plan could be arranged). For one, the costs associated with side effects (in terms of cost to them), imperfect treatments, costs of repeated approval of medical expenditures, and so on can easily outweigh the cost of the "cure." In other words, it could be a lot cheaper. Diabetes comes to mind.

          Thirdly, a good cure for any given ailment would almost surely represent 100% market penetration which would be a large increase for the drug company in almost every case. Remember: each successive treatment (even if only an incremental improvement) for the same problem costs a lot of money to develop, each problem has a number of different competing solutions (none the same, patents have limited lifes (especially once you finally clear all the regulatory hurdles), establish the brand, etc...but a cure would presumably take them all) The drug company would be far better off with 5x as many sales, even if they only sell it at half the price of their previous treatments.

          Fourthly, a cure would allow the drug companies to cut out the middlemen a lot more easily, thereby improving profitability.

          Fifthly, a cure would drastically reduce the marketing costs (because it would sell itself to a much greater degree), which would increase profitability in a major way.

          Sixthly, it is possible to practice discriminative pricing. In fact it is done all the time today. In other words, medicare patients will often pay a fraction of what someone with a good PPO will pay. To the extent that someone is unable to pay, the drug company can tailor its prices reasonably well and the government can also step in and help subsidize costs.

          Sixthly, make up your mind. You guys want to say that corporations are driven entirely by the short term, yet you contradict yourself by saying that they wouldn't do this for the long term. To the extent that they care about the short term, they would certainly go for the cure because their revenues would surely be much larger in the first 2-3 years.

          Seventhly, it is a highly competetive market and in any given market, there are a lot of companies that have almost NO market share. You can be sure that if they were sitting on a cure that they would exploit it. This is especially true for those companies that are desperate for growth today.

          Bah. I won't bother any more, I've got stuff to do. Bye
      • It's not that easy. You always have the choice for what you want to search. If you're a drug company exec, do you tell your scientists: "Let's search for a drug that eliminates AIDS from your blood" or "Let's search for a drug that controls AIDS"? Well, if all you care about is money and shareholders, you choose the second choice because it costs less and because such a drug provides a long term revenue instead of a one-shot. Also, if you are already making lots of money selling drugs that "control AIDS", selling one that cures it will decrease your profits.
      • Umm, the original poster is correct.

        Think about finding the cure for cancer, how much is that cure worth? Or to put it another way how much would a sufferer be willing/able to pay. Now think about a drug that will treat all the symptoms but leave the original complaint. Take the drug and live stop taking the drug and degrade. 1x?$ 30yrsx52weeksx?$

        The profit is in repeat business not curing people. Good business demands you maximise your profits with little or no concern for anything else.
    • How does a RIP-OFF of something Chris Rock said get labelled as "interesting" or "informative"?
    • I work in R&D at a major pharma company, and you are an asshole.

      We bust our hump trying to cure everything from osteoporosis to AIDS and you sit there smugly alleging that we're either holding back cures or not trying to make them? You're a fool. Everyone I work with spends every minute of the work day and most of our weekends trying to develop treatments AND CURES for ungrateful dickheads like you. And we don't do it for the money, which pays the bills but isn't that great, trust me.

      While you're busy making unsubstantiated allegations I'll be inventing drugs to make your life better, you pig.

      • I don't think he's talking about you (the reasearchers). I'd be very interested to hear the decision making process in terms of where your officers decide allocate the R&D dollars.

        What he's saying is somewhat true only in the sense that R&D companies wouldn't (or couldn't) sell cheap effective remedies if they couldn't sustain a huge business. It's not like a company would willingly make itself smaller, or take less profit, for the sake of humanity alone. Nobody is that naive.

        Your work is appreicated, but remember that the reason the suits get paid more is that they have to make the decisions which really have a huge bearing on the future. While you work your ass off, and nothing could get done without you, the decision of what to work on, and with how many resources is a touchy subject .. and those are the things he's blindly attacking.

        Not to say he's right, but I can tell you here at work that just because I work my ass off doesn't mean I can't appreicate that my company directs me to work my ass off for the sole benifit of the company instead of the benifit of our customers or humanity in some situations. My intent may be pure, but to assume that my company, as a system, isn't capable of actions with less-that-virtuous intents would be awfully reductionist.

        Anyhow, hats off to you. Its us in the trenches that make the world work, no arguments there; I just wish sometimes we could have a little more say in identifying what problems we truely think are the most important to solve.
      • What's it like to work at the Umbrella Corporation, anyway? ;-) (j/k)

        We bust our hump trying to cure everything from osteoporosis to AIDS and you sit there smugly alleging that we're either holding back cures or not trying to make them? You're a fool. Everyone I work with spends every minute of the work day and most of our weekends trying to develop treatments AND CURES for ungrateful dickheads like you. And we don't do it for the money, which pays the bills but isn't that great, trust me.

        So you are telling me that upper management would NEVER bury an R&D breakthrough that upper mangement thought would hurt their profits?

        I bet that breakthrough would get "lost" really quick.

        I'm not belittling you, or your coworkers, but when the people who only see numbers start making decisions the bottom line is everything.

        • So you are telling me that upper management would NEVER bury an R&D breakthrough that upper mangement thought would hurt their profits?

          They could try. And when one of the researchers turned whistleblower then the company would get ripped to shreds. Literally.

          That said, if you get bean counters in upper management that are more interested in profits than improving the human condition (and here it's important to note that not everyone in upper management is going to be this way, particularly not at younger firms), then there won't be an R&D breakthrough like you mention because the money won't be spent in ways that are likely to result in such a breakthrough.

          By and large people asking for a "cure to cancer" are showing their ignorance. We've really solved most of the easy problems. The rest are sticky because the solutions are not straight forward. There isn't likely to ever be a pill or a shot that will cure cancer - but there will be increasingly effective regimens of treatment with fewer side effects (most new cancer drugs aren't cancer killers - they're drugs to fight the godawful side effects of the cancer killers).

          But even with that said, it's pretty damn hard to find a cure if you're not looking for one.

          If all of this really concerns you, I suggest donating to a non-profit group which does fund research aimed toward cures and not just treatments. There's a lot of them out there. You can also contribute CPU time toward Folding@Home or the UD Cancer Research projects, both of which are non-profit.
    • You hold a typical cynical teenager view of the world of medicine, here.

      First, what's the difference between treating and curing a disease? Last time I checked the only way to "Treat" a virus is to kill it or disable it. Infections? Try antibiotics (they ALL cure infections). Bacteria? Again, can't treat without curing.

      I'll cut you with my razor now, it's so simple anyone can see it:
      All the companies are looking for cures, because if they're the first with a cure for a disease they'll make *billions* of dollars. There are always moer diseases coming.
      • First, what's the difference between treating and curing a disease? Last time I checked the only way to "Treat" a virus is to kill it or disable it. Infections? Try antibiotics (they ALL cure infections). Bacteria? Again, can't treat without curing.

        A good example is the common cold or influenza. The medicine you get simply masks the symptoms (antihistamine) rather than attacking the virus. Sure you got TamiFlu and the like but even then it only knocks a day or two off.

        Other than antibiotics I doubt there are a whole lot of medicines that actually "cure" the disease rather than to simply contain it or mask it. (I am sure there are some but I am saying in general)

  • by Anonymous Coward on Wednesday October 02, 2002 @02:28PM (#4375249)
    OK, so part of this can be tossed off as a little bit of paranoia, but the patent issue is only a small part of the iceberg that is medical research. There is a dearth of substances out there that fight depression (St. Johns Wort), cancer, and other ailments that no-one is willing to put through the rigorous testing required by the AMA, and FDA because there's NO MONEY IN IT. They can't patent it, so as soon as it's approved, anyone can sell it. It's a sad but true fact that it happens all the time. If you're intersted in starting down the road of true paranoia, look at When Healing Becomes A Crime, The Harry Hoxsey Story if you can find it. try here [lauralee.com] if you're interested
  • by Brigadier ( 12956 ) on Wednesday October 02, 2002 @02:30PM (#4375270)


    My sister used to work for Bristoll Myers. One of her main points was it takes an excess of 8 years to perfect a drug. Wherein a list of ten potentials you may get one that qualifies for clinicals. Now keep in mind your development team for lack of a better word concist of PhD chemist and Biologist commanding a 6 figure per anum paycheck. Now the catch is after all that R&D investment drugs that pass clinicals only have a patent lasting 5 years before generics can be made. Thus the consumers take it in the pocket with high drug prices.
    • Pharmaceuticals have a hard sell.
      Pharmasuticals have a hard spell.
    • Did she tell you how they do drug research? The best way to find effective drugs is to research the ancient use of herbs, spices, plants, and other ways of tribal healing. Many chemists who work for drug companies often travel around the world, getting to know the past. If there is a connection between a tree's root and diabetes, they will attempt to isolate the chemical responsible. Then they will patent it.

      Patents are reinventing prior art.
    • Now keep in mind your development team for lack of a better word concist of PhD chemist and Biologist commanding a 6 figure per anum paycheck.

      Those salaries are just a rounding error compared to the main cost: countless thousands of 6 figure per 30-second TV commercials.

      The 5 years to recoup their investment is really no big deal. They just develop a new similar drug under a new patent with a similar sounding name. That way, they can leverage the millions spent on the old TV ads.

    • by Zeinfeld ( 263942 ) on Wednesday October 02, 2002 @03:00PM (#4375508) Homepage
      Now the catch is after all that R&D investment drugs that pass clinicals only have a patent lasting 5 years before generics can be made

      That is not the case. Drug patents are regulated under a special set of rules that tie the patent term to the date on which the FDA gives approval.

      There is also a set of riders that allow the drug companies to delay introduction of generics evan after the patent has expired. If a patent holder makes any claim against a generic, no matter how frivolous the generic is automatically denied approval until court proceedings on that claim. If the court throws out the claim the drug company can throw in another one. So generics makers are subject to a series of 18 month delays over the enforcability of suprious patents filled over the dosage rates or minor parts of the invention not disclosed in the original.

      The problem is that the congress and president were bought long ago by the drug companies.

    • The hype takes advantage of the fact that you don't do the math. lets say you have a team of 10 making $100k per year (really doesn't happen that often, the researchers are grossly underpaid usually) for 10 years. That's 10 million dollars. Lets say they needed $100 million in equipment, and that all the equipment is single use. For shits and giggles, lets toss another $100 million in expenses in there. That's $210 million, and probably quite generous, because alot of research and equipment will be reuseable for other drugs in the future.

      Now, lets say that each year, 1 million people need to take one pill a day for 1 month. That's 30 million pills sold per year. 150 million pills sold in 5 years. Say it costs $1 per pill to make, package and market. If they charge $3 a pill then they've got $300 million in profit.

      In reality, you get pills that cost tens of dollars a piece, and people take them every day for the rest of their lives.

      It's no secret that these companies make vast profits and rediculous margins. You don't even have to do that little though exersise. Just look at the data and you'll see that their prices could come down significantly and they'd still make a profit. They're publicly traded, and they have to reveal that kind of stuff. If they're not doing any new research, then where is the money really going? Marketing, lawyers, and executives. Now, the US is a free country, and these companies are certainly allowed to profiteer, but the public grants these companies this ability at their own cost. We need to ask ourselves every once in a while just who benifits from our policy, and wether it's still in our best interest.
    • And treat like a real war: the US has the best military in the world through a public sector dominated partnership with the private sector.

      While free market evangelists will defend the pharm industry with their dying breath, it's obvious to the rational that there are inherant conflicts between finding the best cure and making the most money.

      So we should treat the fight agains disease as the war that it is: it's a war America is losing, millons of our people fall to this enemy every year.

      The main difference from the Iraqis or wild lions doing this is that the enemy is microscopic, but why should that stop us from realizing we are in a WAR with disease, not a market?

      The new front is regenerative medicine, and it may well not be very profitable. But it has the potential to lead to real cures...

      More:
      http://www.liebertpub.com/reg/default1.as p
  • Perhaps we've just reached the limit of what can be done. Perhaps there are no more major innovations to make. Perhaps, just perhaps, we've reached the end of the line.

    Bacteria will grow steadily more resistant, Viruses will continue to spread, and only the strongest will survive.

    Civilization has allowed the human race to accellereate it's proliferation far beyond any hope of a state of equilibrium. Disease and illness is nature's way of reducing the population and limiting our growth.

    The Earth is choking on the glut of humans. We have reached the point where we can no longer continue the fight against nature. Soon, the planet will once again wipe out the majority of the human race, leaving only the disease resistant to survive.

    Of course, this really sucks for the weak of body and strong of mind, as well as for people with allergies.

    Nature is preparing the mother of all bitch slaps for humanity.
    • "Perhaps we've just reached the limit of what can be done. Perhaps there are no more major innovations to make. Perhaps, just perhaps, we've reached the end of the line.

      Bacteria will grow steadily more resistant, Viruses will continue to spread, and only the strongest will survive."

      We can probably turn back the clock a bit on bacterial resistance by eliminating or severely curtailing their use in livestock. New antibiotics come out and get used in animals for years before they ever get approved for humans. By then you already have several classes of bacteria resistant to them. Livestock gets low doses of antibiotics with feed, and this fuels that problem as do things like cattle feed lots where animals are forced to wade through several feet of their own feces (filled with antibiotic resistant bacteria, eh?).

      Cows consume 9 times the amount of antibiotics per weight humans do. Humans live 70-80 years. Cattle for slaughter rarely see age 2. Dairy cows tend to survive 4 maybe 5 years at most. Calfs selected to become veal are lucky to see 6 months. These animals have a potential to live 18-25 years, but that isn't a reality in factory farming. Almost every case of bacterial resistance started in livestock, *NOT* in people. But what do you see in newspapers and TV about it? "Doctors shouldn't indiscriminately hand out antibiotics to people" ..They almost never mention the livestock problem.

      (They call this "Public Relations" & "Image Management". I call it willfully misinforming the public for personal gain.)

      The situation with pigs, chickens ...is not encouraging either. If we don't stop the abuse of antibiotics in livestock, we are going to lose them forever for people irregardless of how many doctors don't write that indescriminate script out for a human.

      As far as "reaching the end of what we can do". Bah Humbug. The world wide benefits that could be achieved by finding effective treatments & cures for malaria alone are compelling. Unfortunately most of the people who live in areas where it's a problem can't afford to pay several hundred dollars for treatment, so drug companies don't do the work. The US public sector doesn't do that wotk either -- it isn't a problem here anymore. Things like west-nile may change that. You can bet that the vaccine for that will be developed with public and not private money as well.

    • Maybe you're right, we're toast. We can extrapolate current behavior of companies and society out into infinity and see it so clearly. Or maybe you are being Malthusian. [impermanentpress.com]

  • Scary... (Score:5, Insightful)

    by GreyWolf3000 ( 468618 ) on Wednesday October 02, 2002 @02:32PM (#4375287) Journal
    Moreover, drug companies have learned that when they can't create a new drug to treat an existing illness, they can create a new illness to treat with existing drugs. GlaxoSmithKline's multimillion-dollar promotion of anxiety disorder as a pernicious national problem enabled the company to make billions more selling Paxil--a drug most experts believe is needed by only a small fraction of the people who take it.

    This quote speaks for itself--perhaps we need to keep this in mind when we think about drug legalization/criminalization: perhaps we're all getting "pushed" and duped. Not to say that the whole system is corrupt (or to imply FUD)--but this does put the situation a new perspective.

    My guess is that they've been doing this for years. It's amazing how many illnesses such as ADD and ADHD (that most likely come from legitimate sources) come to inflict millions and millions over. This is coming less than a month after the US government has pushed tons of money in preparing states to universally vaccinate all citizens for small pox. I don't like the idea of the government pumping needles in everyone's veins either (call me crazy).

    I sure as hell hope there's not foul play here (not specifically the smallpox case), but if the shoe fits...

    • Offtopic, yes (hence my No +1):
      This is coming less than a month after the US government has pushed tons of money in preparing states to universally vaccinate all citizens for small pox. I don't like the idea of the government pumping needles in everyone's veins either (call me crazy).

      I think smallpox vaccination is a GOOD idea. Read this [cryptome.org]. You will, too.

      S

      • Smallpox vaccination at this time would result in many more problems with complications due to the vaccinatiuon than prevented.
        • Re:Scary... (Score:2, Insightful)

          by RealAlaskan ( 576404 )
          Smallpox vaccination at this time would result in many more problems with complications due to the vaccinatiuon than prevented.

          Are you sure about that?

          The question seems to be:

          ``Should we:

          a) vaccinate before the emergency, or
          b) hope there isn't an emergency, and try to vaccinate when it happens?''.
          If we vaccinate now (option a), we can make it voluntary and doctors can have all the time they need to screen their patients, and screen out people who are at high risk for problems. Furthermore, even partial vaccination makes the spread of disease less likely. If enough of the population is vaccinated, an outbreak might not turn into an epidemic at all, and the emergency might fizzle. Unfortunately, some people will have bad reactions to the vaccine, and will be significantly harmed.

          Under option b, we hope there isn't an emergency. If we get lucky, smallpox is never released, and there are no casualties. If there is an emergency, we can be sure that it will be worse under this option. I've heard that once infected, smallpox has a 50% fatality rate, given proper treatment. In an unvaccinated population, it will spread far more widely than in a partially vaccinated population. In the mad rush to vaccinate everyone, some people who should be vaccintated probably will be missed, with consequences fatal to them and/or others, and some people who probably shouldn't be vaccinated certainly will be, with fatal consequences for a few of them.

          Option b seems to clearly have higher casualties, given that the emergency occurs. The only way that option b is preferable is if we really believe that the odds of smallpox being released are small enough that P(smallpox)*((number of deaths in epidemic without vaccination) + (number of deaths from involuntary vaccination)) < (number of deaths from voluntary vaccination)+P(smallpox)*(number of deaths in epidemic with vaccination).

          Play with that inequality a bit; I think that you'll find that the question isn't trivial and the answer isn't obvious. Option a has the advantage that folks who want to can take a risk, and reduce the risk to the rest of us. If an epidemic comes, they'll be sitting pretty, and we'll be happy they aren't in line ahead of us for the shots. Option b forces everyone to get vaccinated when we are attacked, like it or not. Given that we don't know P(smallpox) is small, it seems insane to force everyone into option b.

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

        by ponos ( 122721 )

        Small pox vaccination is not a good idea.
        Common vaccines, such as the polio vaccine
        cause 1:100000 >deathsbad vaccine (not perfected and definitely
        less safe than most typical vaccines! read
        NEJM (www.nejm.org)) and also note that
        there is no existing small pox threat.

        It may be ok to have 10-100 children die
        every year because of vaccinations against
        real diseases but would it be ok to lose
        even a single person from small pox
        vaccination to protect against a theoretical
        threat?

        P.
    • by willpost ( 449227 ) on Wednesday October 02, 2002 @02:45PM (#4375403)
      Parents of children diagnosed with attention deficit hyperactivity disorder (ADHD) will face jail under proposals in the new Mental Health Bill if they refuse to drug their children, a psychiatrist has warned.

      http://news.independent.co.uk/uk/health/story.jsp? story=337626 [independent.co.uk]
  • Atrocious (Score:3, Insightful)

    by drhairston ( 611491 ) on Wednesday October 02, 2002 @02:33PM (#4375298) Homepage
    I give the writer a D+. While excellently written, I cannot give a passing grade to anyone who fails to support their contention with examples. While there are mentions of stale drug innovations, there is no reference to a supportable causal link between patents and stifled innovation. If there are no new innovative drugs, can we point to this, wave our hands, and conclude that patents are the cause?

    No.

    But if we are to make unsupportable contentions, I will play along. I contend that patents carry far less blame than the rigorous testing procedures drugs must endure to pass the FDA. I will even cite some concrete examples: RU486, available in Europe for years, and Splenda/sucralose, also available in Europe ages before hitting U.S. shores. If other countries are willing to take risks that the U.S. and its lawyer-centric culture shy away from, perhaps we should get to work recruiting client states (and their citizens) to test experimental drugs to combat the world's most pressing problems: AIDS and Malaria.

    But perhaps that's asking too much.

    • examples? (Score:4, Informative)

      by martissimo ( 515886 ) on Wednesday October 02, 2002 @02:45PM (#4375406)
      it may not be heavily example laden, but there are certainly a few examples cited in the article:

      Last year Peter Ringrose, then the chief scientific officer at Bristol Myers Squibb, told The New York Times that there were "more than 50 proteins possibly involved in cancer that the company was not working on because the patent holders either would not allow it or were demanding unreasonable royalties."

      and

      Two years ago Chiron Corporation stopped hepatitis C vaccine research at four other companies by refusing to license one of its patents. Recently, as the result of work by the National Institutes of Health (NIH), Human Genome Sciences (HGS) learned that a receptor it had previously patented was actually an important pathway for HIV to enter cells. The result: HGS can now stop competitors' aids research.

      and

      Roach believes firmly in end-product patent protection, but he thinks that patents often "put an artificial tourniquet on the flow of a new discovery"--a belief informed by his own company's inability a few years back to get a license it needed in order to do work on hepatitis A

      yup this article seems to provide absolutely no examples to support it's case whatsoever
  • Many of us readers at Slashdot said it once and many times, patents DO NOT WORK. The patent office has said that there are too many silly patents, etc.

    Patents are given monopolies that stop innovation. We have come to a point in the development of technology where there are best practices and building blocks. A hundred or two hundred years ago you start from scratch and hope to make money. But this is not the case today. In the past people could decided between DC or AC electricity. But now we are locked in AC, locked into roads that have certain rules, cars that burn gas or diesel, houses that have glass windows.

    My point is that we have so many best practices that when a patent comes along that sets another best practice it stops innovation. Since getting around that best practice is basically impossible.

    And since we are now truly building evolution technology patents should not be allowed.
    • by windex ( 92715 ) on Wednesday October 02, 2002 @02:43PM (#4375386) Homepage
      I would like to note, though, as a Slashdot reader, that I don't beleive it's always been so bad. I think that the major problem is with the system now is that people can learn and adapt to things much more quickly, making a patented application much less useful to migrate into the scheme of "bigger and better things". Your average human being is considerably smarter than they were when the system was developed, but the system hasn't noted that concept yet (by shortening patent timelines, creating a a provision for public challenge of patent applications .. which is sort of happening now, etc).
      • Part of the problem of a patent is that in this day and age there are no novel inventions. There are interesting inventions that build on others. And because there are X million techies it is bound to happen happen that multiple people come up with the same answer. Hence nothing is novel and unique.
  • Summary (Score:2, Insightful)

    by f97tosc ( 578893 )
    For once I actually RTFA, in particular I was looking for explanations for how patents could actually harm research. These can be summarized as:

    1 Companies put a lot of effort into getting patent protections extended and generalized, without really improving the product.

    2 Companies are reluctant to start completely new research because there is a great risk of infringing on somebody else's patents.

    I am a proponent of patent protection, but these two arguments actually made me think again. As the comment goes: it's much easier to argue that `patents support innovation' than to try to explain that some patents are good for innovation while others are bad.

    That being said, I think we should stay with a few solid principles rather than laying out a complicated network of legislation to maximize some utility function. The latter is an invitation to a situation much worse than today.

    Tor
  • by avdi ( 66548 ) on Wednesday October 02, 2002 @02:40PM (#4375358) Homepage

    As this article [jpost.com] points out, one reason big drug companies are stepping away from AIDS drug innovation, at least, is because of AIDS activists and other anticorporate do-gooders. By forcing companies to practically give away their drugs to the third world, these misguided crusaders have removed all incentive from Big Medicine to research new AIDS drugs. Any new drug development requires an immense amount of R&D capital before a cent of profit can be made; and no intelligent CEO is going to throw billions at a product that'll wind up being either given away or copied illegally by third-world manufacturers.

    • As this article [jpost.com] points out, one reason big drug companies are stepping away from AIDS drug innovation, at least, is because of AIDS activists and other anticorporate do-gooders. By forcing companies to practically give away their drugs to the third world, these misguided crusaders have removed all incentive from Big Medicine to research new AIDS drugs.

      Oh, great, and so thus we should kill off as many of the poor as possible so that drug companies can continue to make their money, huh?

      If you assume a profit-oriented pharmaceutial industry, then, yeah, you're right; they can't make their profits if they don't have the ability to limit the availability to those who can pay.

      Is this really the system we want?

      I strongly believe that (a) pharmaceutical patents should be just flat outlawed-- not granted any more, not enforced, they're just sacrificing life and health on the alter of intellectual property; and (b) medical research should be grant supported like any other reserach. The savings due to lower drug prices from (a) (due to generics being availble, pricing drugs only on the cost of production) could probably more than make up the cost of having to government fund research under (b) (which would, yes, be a huge cost, since it would have to pay all the scientists and researchers, though it wouldn't have to pay the marketing costs that the current system incurs). The advatange of this system is that we would be using the system for funding research that works in all other brances of science. And, the knowledge that comes out of that research would be open, and usable to the best benefit of humanity, rather than primarily to the stock portfolios of those who invest in pharmaceutical companies.

      -Rob

      • Oh, great, and so thus we should kill off as many of the poor as possible so that drug companies can continue to make their money, huh?

        No, it's people like you who would kill off the poor in third-world countries to satisfy your own notions of social justice. No government in history has ever equalled the kind of productivity that our competitive market creates - and you would take that productivity away from the search for lifesaving drugs.

    • That's a great PR story, unfortunately it has just one major problem ... It's major bull. I wonder which PR company handled that? Hill & Knowlton? Shandwick? It has their feel. I'm sure I'll read about it in a few months in PR-WATCH.

      Private companies never did. Every single AIDS drug on the market was studied, researched, developed, and subsidized with public sector money. Every single one. Even the "manufactuing process" research was generally done with public money. The NIH usually gives away it's drugs & research to companies to make a profit with ...but it's a rare event when they completely pay for the process to figure out how to mass produce them as well. They did this for just about all of the AIDS drugs in addition to developing them, and funding all of the research and testing. The private sector only spent money on "PR" to say what a nice bunch of guys they were. Nor did we put any restrictions on what they could charge for these drugs until very recently and we fought tooth and nail to keep other countries from manufacturing them at selling them at close to cost. The private sector didn't "lose any investment" ...They simply lost a very small portion of their guaranteed profit on drugs they were handed on a silver platter from the public treasury.

      How much subsidy can the truth take?

      "As this article [jpost.com] points out, one reason big drug companies are stepping away from AIDS drug innovation, at least, is because of AIDS activists and other anticorporate do-gooders. By forcing companies to practically give away their drugs to the third world, these misguided crusaders have removed all incentive from Big Medicine to research new AIDS drugs. Any new drug development requires an immense amount of R&D capital before a cent of profit can be made; and no intelligent CEO is going to throw billions at a product that'll wind up being either given away or copied illegally by third-world manufacturers."
      • Uh - you're missing one point. Most of the money on drug development is spent AFTER a lead is found. The NIH does not do clinical trials of drugs.

        What companies buy from the NIH are good ideas - most of them turn out to be duds. Sure, many compounds on the market were originally thought up by the NIH, but if you took the average NIH lead and injected it in people at random, you wouldn't cure AIDS - you would kill people.

        The big pharma companies add value by formulating the lead into a drug, and then testing it and killing the development cycle most of the time when it doesn't work.

        The public is reimbursed from publicly developed lead molecules - they are usually auctioned off. They don't fetch much - but that is because they aren't worth much individually - most don't actually work. If you demanded huge royalties they just wouldn't sell at all.
  • Cap royalties (Score:3, Interesting)

    by Tablizer ( 95088 ) on Wednesday October 02, 2002 @02:42PM (#4375376) Journal
    I think one solution would be to put a cap on the royalties that one has to pay to X percent of the product revenue. If multiple patents are involved, then the *total* still would be no more than X percent. X is simply divided up among the patent holders.

    There is too much all-or-nothing problems and out-of-the-woodwork surprises right now. If you know that the total will be no more than X percent no matter what, then you are more likely to take the risk. There is too much "patent paralsys" right now.
  • by SacredNaCl ( 545593 ) on Wednesday October 02, 2002 @02:45PM (#4375400) Journal
    Just about every major drug development in the past 15 years has come from the public sector, not the private sector. Cancer drugs? Almost 100% public sector. AIDS drugs? 100% public sector. Antibiotic research? ...Same thing.

    What is the private sector doing? "Weekly" Prozac, "Extended Release" Acyclovoir, "Controlled Release" Pain Killer/Paxil ...Or change one molecule, or change chilry slightly in the process ... Or launch patent on what the drug becomes once it enters the body to extent patent ...Lobby congress for patent extension ... etc

    I'm not saying that some of the controlled release drugs aren't quite useful -- but the mechanisms for making them controlled release are rarely innovative. Add Wax, or Cellulose to pill ..That's 90%.

    Add in captive market pricing (drug in US $212, same drug in Peru $7, same drug in Mexico $12, same drug in Australia $117). ...And you have some real scum at work.

    But drug companies have some some other shady things -- like using their influence at the FDA to keep new drugs from Europe off of the US market while they work on a one off version for release here. I'm sure some countries in Europe are doing the same thing. One of those areas that trade treaties don't really cover well.

    • AFAIK, Ciprofloxacin is one of the first totally synthetic antibiotics - it acts by preventing DNA replication and hence cell division. Most antibiotics previously came from fungus and mold.

      Isn't Ciprofloxacin patented by a major drug company?

      • It was patented, but it's now in a gray area. It was targeted as the one antibiotic that can help with Anthrax so the Federal Government forced some interesting rules on Bryer to see that it is made more available and at a much cheaper price. Funny thing is that most antibiotics do a decent job with Anthrax, not just Cipro.
    • Not totally true. (Score:3, Insightful)

      by nachoworld ( 232276 )
      Just about every major drug development in the past 15 years has come from the public sector, not the private sector.

      Simply not true.

      Antibiotics are mostly private sector. You might be implying that drugs that are life preserving don't usually come from the private sectors. There are plenty of good examples of life preserving drugs (antibiotics). There are also plenty of good examples of life-enhancing drugs (omeprezol - Prilosec). Or the combination of the both (silfenildil - Viagra was originally indicated to reduce heart attacks, but it had an interesting side effect).

      IT IS NOT CAPTIVE MARKETING!!! Blame foreign governments for the high prices here. They don't allow drug companies to charge for R&D costs.

      But there are two sides of the argument here too. Here's an analogy The US may be seen as flying first class. They get from point A to point B but pay a much larger price than those in coach (foreign citizens buying drugs). But if airline companies started charging less for first class and distributing the cost to coach, then fewer people are inclined to pay for coach. There are much fewer people on the plane. The plane never leaves the ground.
    • I have done research in the private and public sectors (see my homepage for my publications), and I think that both sectors are valuable, but it is simply nonsense to say that drugs come out of the public sector. Please give a list of drugs that according to you came out the public sector.

      The public sector does basic research, and the private sector does use this information to create products by applied research, sometimes generating more basic research as well. No university lab has the funding to conduct the sort of research and clinical trials required to bring a drug to market -- it is simple economics.
  • by Theatetus ( 521747 ) on Wednesday October 02, 2002 @02:50PM (#4375433) Journal

    The cliché of the moment is that pharmaceutical companies have picked the low-hanging fruit, developing drugs that interact with the limited number of enzymes and molecules that we already understand and have thoroughly modeled.

    And some luddite famously quit the Patent office in 1870-something because he determined everything that could possibly be invented had already been invented.

    Corporations aren't like people. If you leave a guy alone to do his job, he generally does it and even finds a better, more eficient way to do it than you taught him. If you leave a corporation alone to fulfill its mission statement, it tends to get lazier and lazier and do less and less

    Before the free-market theologians jump in and remind me that a corporation's sole purpose is to make money for its shareholders, let me quote some mission statements from phramaceutical companies:

    • Pfizer: "We will become the world's most valued company to patients, customers, colleagues, investors, business partners, and the communities where we work and live."
    • Genentech: "Our mission is to be the leading biotechnology company, using human genetic information to discover, develop, manufacture and commercialize biotherapeutics that address significant unmet medical needs."
    • Merck: "The mission of Merck is to provide society with superior products and services -- innovations and solutions that improve the quality of life and satisfy customer needs -- to provide employees with meaningful work and advancement opportunities and investors with a superior rate of return."

    Those were just the first three I happened to look at; the rest seem similar. So, there you have it straight from the horse's ass^H^H^H mouth: these companies' missions are not primarily to return profit (Genentech doesn't even mention that); all three have medical innovation and discovery as their primary mission. Just goes to show you can't trust a corporation to do what it sets out to do.


    • Corporations aren't like people. If you leave a guy alone to do his job, he generally does it and even finds a better, more eficient way to do it than you taught him. If you leave a corporation alone to fulfill its mission statement, it tends to get lazier and lazier and do less and less

      Am I a corporation? My performance alone is EXACTLY like the second behavor!
    • Those were just the first three I happened to look at; the rest seem similar. So, there you have it straight from the horse's ass^H^H^H mouth: these companies' missions are not primarily to return profit (Genentech doesn't even mention that); all three have medical innovation and discovery as their primary mission. Just goes to show you can't trust a corporation to do what it sets out to do.

      Or that you really shouldn't pay much attention to corporate mission statements.

      There's a simple reason you don't see "make a profit" written in there is because it's a given. It'd be like me writing "wake up, breathe, eat" in my to-do list every day.

      A private company that doesn't make a profit won't last long enough to accomplish anything, at least not unless it's kept on life-support by some source of outside funding (and that really just pushes the problem further away.)

      But profit isn't the goal. It's just the means by which to reach the goal. Companies that forget that little detail are the ones that get in trouble, because they become so preoccupied with doing anything to make a buck that they forget how to actually do the things the company exists to do.
  • Ick. (Score:2, Informative)

    by Arcaeris ( 311424 )
    The fact that so many of these posts are modded up as "insightful" is insane. The biotech industry is one of the fiercest out there.

    Patents hurt drug companies as much as their business model and costs do. They must constantly produce *results* and *product* at a much higher rate and much more competitive environment than most industries. Without upstream patents, anyone could horn in on development and steal it away. Recent innovations in Solid Phase Synthesis really streamline the production of analogues to various drugs. Once something is found that has the desired effect (to any degree), all related compounds can be made AND tested in a very short time. The long period is in clinical trials and FDA approval. So once a company finds something and patents the process, it can own a whole set of molecules. So if any information is leaked out, a rival company could have found a better/more active/more specific similar product in a very short time. With the short duration of downstream patents and the high cost of R&D, the biotech companies have a difficult struggle to stay afloat.

    Not to mention competition from universities, whose costs are paid by the government. The lab I work in, which consists of just 5 people, easily spends $2000 A DAY on just supplies.

    So, a hard question is raised: How do you allow these pharmaceutical companies to compete in such a tough environment against competitors that have no costs and deal with patents, while still promoting miraculous developments? Our current system seems do a good job of most things, though generally poorly. I really don't have an answer.

    One company, however, had a good idea. They gave us several thousand dollars in new product (which needs some testing as to what it does and is good for), some more money to pay labor, and just expects us to publish some (hopefully important) papers about it. The university is getting most of the cost of the research, and the company will get good advertising for their protein complex, which they can then sell. Seems like a good bargain, on a small scale.
  • Just Pisses me off (Score:3, Interesting)

    by BrookHarty ( 9119 ) on Wednesday October 02, 2002 @03:07PM (#4375565) Journal
    Quick overview.

    1. Pharmaceutical companies have big ties into our government, controlling legislation.
    2. Pharmaceutical companies can patent receptors which blocks other companies to interact with those receptors.
    3. The FDA has limited manpower, which means less drugs tested.
    4. Knowledge which researchers shared freely, is now corporate information, and locked away.
    5. Pharmaceutical companies are holding licenses. Screwing the public on new drug treatments from other corporations.

    And my favorite.

    6. breweries-and-distilleries index are up 25 percent; shares in the pharmaceuticals index, meanwhile, are down 25 percent.

    • by TheSync ( 5291 ) on Wednesday October 02, 2002 @03:49PM (#4375936) Journal
      1. Pharmaceutical companies have big ties into our government, controlling legislation.

      50% of every dollar spent on medicine in the US comes from the Federal Government. No big suprise it is politicized. With prescription drug coverage for Medicare coming, the percentage will rise.

      3. The FDA has limited manpower, which means less drugs tested.

      This is wrong. Every drug is tested by its maker, on its maker's dime. The FDA only requires testing and examines results. The average cost of testing is near $100 million, and the drug may then not work (most don't make it through testing). Backups due to the FDA do not lead to untested drugs being released, it leads to fewer drugs being released.
  • by Anonymous Coward
    I am not joking - there must be loads of chemists and doctors out there who could make it work.

    They could do research, and let drug companies make a small profit out of the resulting product - after all, the drug companies wouldn't have had to pay directly for the research - in return for the drug companies agreeing to do research such as clinical trials, which has to be government monitored. The governments could give large tax breaks for the drug companies supporting the successful drugs, which would urge them to take it seriously, not just sit back and think, 'ah, we can make some residual money on this'. There should be big bucks for a cure for cancer, and honors for the sponsors, and open source scientists, who lets face it, would be able to get a job just about anywhere if they were credited in that way.

    For crying out loud, people are dying. The open source model could really do some good here.
  • by CommieLib ( 468883 ) on Wednesday October 02, 2002 @03:24PM (#4375705) Homepage
    1. Drug companies exist to make profit for the shareholders.

    2. Drug companies seek to maximize their profit by extending patents.

    3. Presumably, money cannot be spent on both legal matters and research.

    So it is the extensibility of patents, and not patents themselves that is "choking off" research. This is a very different thing to say than "the patents are choking off research". To fix this problem, if it is a problem, we need to tighten the laws regarding patent extensibility. Agreed?

    This whole golden goose B.S. bugs me. Can someone explain to me why someone would shell out 50 million dollars to develop a drug if, after the research is complete, my competitors can benefit equally from it?

    I think the general idea is to socialize drug research. That would be great, because then results wouldn't matter. Not only that, but we would have a value judgment forced on everyone as to the value of drug research (I don't care if you think that paying your credit card bill this month is more important, we're still taking your tax dollars for drug research).

    The real problem here is that people just cannot deal with the fact that there's only so much money and time and resources to go around. We wish that everything could be a priority. But it can't, so we have to use some system to ration those scarce resources. A free-market system says that resources will be rationed according to private agreement and negotiation, but there's always a few "never studied history much" folks who think that concentrating power and information is the way to Utopia. The road to hell, etc.

  • The more you tell a kid they cannot do this or that, the less they will do in their life.

    The more constraints you apply in the way of "Cannot" based laws, the more constraints will constrain.

    It's really all rather inherently inherent.... knowledge begets knowledge unless knowledge to constrain begets more knowledge to constrain.

    What we really need to do is grab a copy of the Declairation of Independance and use it as a inspiration to write a "Freedom to Innovate and Be Creative" document that will act as a foundation for creating laws that protect innovation and creativity, rather than suppress such.

    Hmmm now where is Lawrence Lessig and the EFF in supporting the proactive offence rather than being bound up in subjective defence?
  • Is this guy supposed to be telling us something we don't already know?

    We all know damn well that no company in any industry is concerned about their consumers/users and the public good first. Companies are only concerned with the bottom line; those that aren't go out of business. A companies first goal is to make money, and the public good, consumers, users, the environment, anything, is only secondary and considered in regard to how it affects the bottom line.

    This isn't something companies should necessarily be chastized for. Their first obligation by the law is to maximize profit for their shareholders while obeying the law. But some companies use illegal, immoral, or unethical means.

    What this means is that you can't trust anything a company tells you. A company's position on social issues is never consistent and will always vary, depending on what will benefit that company the most. In "The Future of Ideas," Lessig noted that AT&T's position on whether or not cable lines should be open changed when from "open access" to "no way" when it became a large owner of them.

    That said, some industries have engaged in reprehensable behavior (biotech, software, etc), while others have no (referring here to non-technological industries, such as clothes industry).

    In particular, the biotech industry has:

    (1) Biopirated (stolen) treatments and cures for diseases from indigenous peoples around the world, patented those ideas, then turned around and charged indigenous peoples for the cures they themselves created.

    (2) (In conjunction with the software industry) extended patent rights and duration beyond all reasonable grounds. Companies can patent things for which they do not even know what they do. They can also receive patents on very basic and primitive things which are no-where near leading to a drug, but which will be needed to be used in the research necessary to product a drug (upstream patents). Upstream patents should be retroactively eliminated (retroactive elimination is OK in this case because the gov't had no right to create them in the first place). Only downstream patents on a specific drug should be allowed; minor modifications to the drug should not result in a new patent. The standard for obtaining a patent needs to be dramatically raised. Every minor and trivial adaptation of an existing drug does not deserve a patent. Furthermore, patents on downstream drug products should not apply to basic research. Universities, governments, and companies should be able to obtain the drug in question for research purposes at the cost of production, without licensing hindrances.

    (3) Denied people much-needed cures/treatments to further their bottom line. Companies have prevented patients from being treated so that they can get royalties on drugs. Lets save some scorn for the Universities too, which are recently becoming nothing more than corporations who also teach and train. My own University of Rochester was granted a patent to cox-2 inhibitors [rochester.edu], which are used in Celebrex's anti-arthritis drug. The University received a patent recently (after Celebrex created the drug) and then filed lawsuite against Celebrex, potentially stopping those suffering from arthritis from getting the drug. While my respect is due to those at the UOR who researched cox-2, that research was done using public grants (which come out of the taxpayers pocket) and using the tuitions of students. It should be put in the public domain.

    (4) Denying people in third world countries cures. Rather than allowing companies in third-world countries to make generic drugs and sell them cheaply (saving millions of people's lives), drug companies have tried to prevent such. Blinded by their greed, they have failed to realize that you can't squeeze water from a rock. Perhaps drug companies would be happy if people in the third world started selling them their body parts in exchange for drugs.

    (5) Used propaganda to create the illusion that certain illnesses exist which in fact don't, boosting the sales of marginally useful drugs.

    (6) Spent far far more money on lawyers, public relations, lobbying, and paying greedy executives than on actually doing research to find cures (not that any company is researching cures anyways).

    I could go on and on.

    The point is this patent non-sense has to stop. Its a problem everywhere, but most importantly in the biotech industry where its a problem that get people killed by preventing people from being treated, or preventing cures from being researched. As harmful as copyrights are given the fact that their scope is overly broad and their duration overly long, patents are an even bigger problem for the same excesses.

    Initial innovation needs to be followed by subsequent innovation, sequential innovation; patents, in their current state, prevent this. I have a simple solution for this:

    (1) Reduce the duration of patents. 10 years instead of 20.

    (2) Force patent-owners to license patented drugs to those who wish to incorporate them into a product to be sold. A forced license of 50% of the profit from the venture going to the licenser is fine.

    (3) Force patent-owners to license patent drugs to anyone for research purposes under a minimally restrictive license. The drug should be provided (for research purposes) at the cost of production, and the only limitation to the license to use it is that the drug itself cannot be sold.

    (4) Prevent drug companies from strategic licensing. A company sitting on a patent while research is done based off of that patent and mentioning nothing, then when a product is made, suing for royalties, should be prohibited. (I'm referring here to the same thing happening in the drug industry [i.e., with cox-2] that happened with MP3's).

    (5) Retain a much stricter patent-granting scheme. Patents should not be granted for things which aren't really innovative. Currently, patents are granted on every minor modification of an existing drug.

    (6) Hold a strong stance on patent nullification of patents ill-gotten. Patents should not be granted for drugs obtained via the results of biopiracy. Those which are discovered to have been obtained from that should in invalidated. Similarly, patents should not be granted on things which were previously invented by others. Should such happen, the patent should be invalidated.

    (7) Punish companies for inappropriate patent behavior. If a compoany inappropriately attempts to use its patents to halt, or obtain patents by biopiracy, etc, it should lose all of its patent rights.

    (8) Prevent universities for filing for patents, or if they do, require them license the patents under a "patent-left" license. Universities obtain their money for research from the public -- from government grants, funded by the taxpayers, or from students tuitions (also basically the public). Thus, their discoveries and/or inventions should either be in the public domain or patent lefted; i.e., a license corresponding to that of the GPL -- any discoveries/inventions using this patent must either be put in the public domain or licensed under this license, which allows unabridged access.

    It is ever-important that we put these kind of restrictions on drug companies (and any technology companies). They will not govern themselves and act morally; indeed, it would be double standard to expect them to do so, since our laws require that they use any and all legal means to maximize profit for their shareholders. Thus, we need to make laws which prevent this kind of nonsense.
  • by TheSync ( 5291 ) on Wednesday October 02, 2002 @04:00PM (#4376019) Journal
    (My wife is still alive because of a recent drug discovery, so I suppose that perhaps my view is pro-drug-manufacturer...)

    Celbrities, Pharmaceutical Researchers Urge House to Reject Patent Legislation that Would Harm Patients [phrma.org]


    Tell legislators that changes to patent law would slow development of new drugs
    October 01, 2002

    Washington, D.C. - A group of celebrities and pharmaceutical researchers, including television talk-show host Montel Williams and actress Kate Jackson, urged the U.S. House of Representatives to reject pending patent legislation that would harm patients by slowing the development of new life-saving, cost-effective medicines.

    Along with Williams, who has multiple sclerosis, and Jackson, a breast-cancer survivor, the celebrities included television personality Leeza Gibbons, whose mother suffers from Alzheimer's disease; Peter Samuelson, a movie producer who has diabetes; and Nancy Davis, founder of Race to Erase MS, who also has MS. The group held a press conference on Capitol Hill before visiting Members' offices.

  • by paiute ( 550198 ) on Wednesday October 02, 2002 @04:07PM (#4376077)
    I work in an industry that supports the very early stages of drug discovery at all the large pharmaceutical companies, so I can give you a different perspective than the author, who is apparently not a chemist.

    First of all, the complaint that "Nexium... is essentially AstraZeneca's old heartburn drug Prilosec with a minor chemical twist that allowed the company to extend its patent." is shallow. Prilosec was a racemic mixture - a mixture of two mirror-image molecules with the same atomic connections. This is the old way that bioactive molecules with one or more chiral centers were patented and sold, because it was too expensive or impossible to separate the mixture into its chirally-pure components. Unfortunately, the mechanisms of the body are chiral, and often it is only one of the mirror-images which is the active ingredient. The other enantiomer is at best inactive and at worst toxic, mutagenic, teratogenic, etc. It is only with the chiral preparative and analytical methods and tools available in the last 15 or so years that it has become economically feasible to either prepare only the active enantiomer or to purify away the undesired enantiomer from the mixture. This is what AstraZeneca has done. From Prilosec to Nexium is not a minor chemical twist - it is a profound biochemical change. In the meantime, anyone else could have separated Prilosec into its components and patented only the active enantiomer, which is what a company called Sepracor has been doing. Sepracor is a company specializing in chiral separations. They have been taking patented compounds and isolating and patenting the active ingredient. Sometimes they license the compound back to the original manufacturer, but if the holder of the patent on the racemic mixture doesn't want to pay, Sepracor sells it themselves or in partnership with another firm.

    Second, my customers are under constant pressure to shorten the discovery pipeline so that successful drugs can be sold under patent protection for as many years as possible. That means more work for me, luckily. To argue that the patent process is wrong or flawed is to ignore the full shelves in the pharmacy. If it weren't for the patent process, those bottles would be full of roots and bark. (Not that there is anything wrong with roots and bark, just that they may also contain toxic compounds.)

    Which reminds me of: third, the author confuses small-molecule patents with biochemical patents. The old school (classical small-molecule therapies) patent system works pretty well. You get some years to make money to fund R&D on new drugs. It is the silly biochemistry and genomic patents which are insane, and the patent office has let them get away with it. From PCR to broad gene therapy claims based only on sequence - that process is as flawed as the software/business model patent crap that is every fifth story on slashdot. This is the area the author should have concentrated on.

    Last, the author gives the impression that there are no new areas for drug therapies out there. This is just a lack of effort on his part. Most drugs initiate change in the body by interacting with receptor proteins on the outside of cells. And each type of receptor - the calcium channel, for example - comes in subtypes which may be expressed in different amounts dependint on tissue type or even on different areas of the same organ. Many of the drugs currently in use do not differentiate very well between the receptor subtypes to which it binds or interacts. There is a huge opportunity for development of drugs which are more and more specific to a specific receptor and so demonstrates fewer and fewer side effects - which are manifestations of interactions with other receptors than the family targeted. The combination of high-throughput screening and combinatorial synthesis, both of which are still in their early stages, promise to supply us with many times more drug candidates than classical one-pot organic preparations and one-rat-at-a-time testing of those compounds.
  • Happened to me (Score:2, Interesting)

    by Anonymous Coward
    I have a genetic indicator for hereditary hemochromatosis, or iron overload. Basically, this means I'm at a higher risk to develop HH, which can cause iron to build up my body. The excess iron, over time, kills off your liver, gives you heart disease, and basically makes your life hell.

    However, there has been very little research on the illness, even though it is one of the most common genetic disorders found in Americans. Why? Because Bristol Myers Squibb owns the patent on the genetic test to find that gene sequence, and charges labs to use the test, or do anything at all with that genetic sequence. Most labs can't afford the fee, nor can they afford the legal battle if they ignore BM.
  • by EXTomar ( 78739 ) on Wednesday October 02, 2002 @04:39PM (#4376365)
    Why is holding a legal monopoly over bodily functions fostering medical improvements? Medical costs are going way way way up. This is an honest question: has anyone shown that patenting bodily functions has improved medical care in the US?

    What happened with being first to market? If one company discovers WonderDrug A cures all that ills, going to market first assures some profit right? As market forces settle in, it then becomes who can make the better quanties at a lower price.

    The problem with current medical patents, as with many patents, is they are too far reaching. *Anything* that has to process BadGene B can be patented even if the resulting medical conditions are seperate. Are companies even sure what BadGene B is linked to when they patent or is it just "patent squatting"?

    I don't know...I seem to remember Salk saying he wanted to make the vacination for polio because he got tired of seeing people suffer. The fact he got money and glory for it after seemed like a nice bonus. Where did that kind of thinking go?
  • A thought...or two (Score:2, Insightful)

    by Cervantes ( 612861 )
    I was flipping through the posts above, and a few thoughts occured to me:

    Me: Why would drug companies make a treatment when they can make a cure?

    Me: Simple. If you charged people $100,000 apiece to get a cure for AIDS, they would riot in the streets and burn you in effigy.

    Me: If people would riot for being charged $100,000 for a cure, then why aren't they rioting for being charged $5,000 a month for a treatment?

    On a different note:

    I agree with most people above. The bottom line of $5,000 a month for 20 years is more appealing than $100,000 a head, and it's just that simple. Especially when that disease is communicable, such as AIDS or HepC. Cure it, and it goes away, treat the symptoms, and everyone gets it.

    And, on another different note:

    Am I the only one absolutely disgusted that research into a cure for AIDS or Alzheimers is being shut down because somebody put a patent on an enzyme? And, more to the point, am I the only one disgusted that drug companies are allowed to make massive profits? Sure, a resonable return on investment should be expected for investors, but to put the future of the species into the hands of Wall Street? I find it humourous that congress can pass legislation encouraging drug companies to test drugs on children, but it can't put strong federal backing behind a cure for AIDS or cancer. Cure those, after all, and thousands become unemployed. Treat them, and everyone gets a nice, cushy job taking care of the sick.

    My grandmother died of a disease that had a cure "in the pipeline". Clinical human trials started just a few months after she went. I found out years later that the drug could have been available almost 10 years earlier, but a copyright lawsuit held everything up as it was appealed to higher and higher courts.

    What scares me is not that this happened.... it's that it might happen to me.

  • ..or PBS for short is the drug subsidising program of Australias social health system. It provides government subsidised prescription drugs (often 75% of the cost or higher) to every australian as long as it is part of the extensive list of drugs that is PBS subsidised.

    A drug may be approved for actual sale in australia, but until it is on the PBS list it is unlikely to be very often prescribed, especially if there is a suitable equivalent drug on the list. What does this mean, "me to" drugs from different companies that treat the same conditions or for a drug with only a marginal benefit usually are sold at a much lower overal cost (before the subsidy is included) compared to the US.
    The commitee of health professionals that decides which drugs are included are able to negotiate with drug companies from a very strong position, if the companies don't get their drug on the list, they won't sell much of that drug in Australia.

    Effectively it is a system for the whole of australia to bargain with drug companies as one large block. And is the reason Australia has one of the lowest (for a while was the lowest, not sure at the moment) per capita spending on drugs in the develop world. Oh and the drug companies absolutely hate it.
  • by tomdarch ( 225937 ) on Wednesday October 02, 2002 @05:21PM (#4376697)
    I have a friend in the pharma industry, and I've discussed the limitations of patents with my friend. I can say that from that sampling group of 1, people in the industry have a very strong perspective that patents are all good. My friend just couldn't get that patenting a DNA sequence that exists in everyone is a bad idea. (You know how you look at Microsoft and realize that they're blind to what they're doing ... it's like that.)

    I think that most people in the pharma industry 1)really want to make money (who doesn't?) and 2) are tied to a specific company at any given time. One looks at the situation and sees that for me to make money, my company must make money and my company can only make money by exercising patents (excluding generics) and my company can make more money by milking the patent system as much as possible (repackaging, etc.) Also, the industry is so 'rules' bound (by the FDA, which I think is a good thing) that they look at rules as a game to be milked as much as possible: first when selling the drugs to doctors regarding labeling and second when manipulating the patent system.

    It's not just the patent abuse. Don't forget that the pharma companies have zillions of high-pressure salespeople pounding on your doctor's door every day. Some are low cut top, batting eyelash, some are "Hey buddy, how's yer golf game, let's hit the strip club! Your escort will be at your room when we get back", some are "here's your check, er, honorarium, for your professional leadership speech at the luxury resort in Hawaii" and on and on. Sure, R&D is expensive, but the marketers/salespeople are paid insane amounts and have massive budgets. A big part of our health insurance premiums are being funneled to the pharma marketing/sales monster.

So you think that money is the root of all evil. Have you ever asked what is the root of money? -- Ayn Rand

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