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Thread: Patents - Friend or foe of capitalism?

  1. #91

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    Quote Originally Posted by thequietkid10 View Post
    The problem with using fashion as an example of patent free society is that it is art.
    It's mainly a business, and one that manages to produce better and better clothes at lower and lower prices. The fraction of household budgets devoted to clothing has fallen by 80% in the last century.

    Pharma, by contrast, an industry totally dominated by patents, charges more and more for drugs that are less and less distinguishable from generics -- and that kill many thousands of people every year through patent-profit-driven over-prescription.

    HELLO???
    And the definition of "art" is so ubiquitous now that I can create art in 2 minutes. I haven't taking an art class since Middle School, but I could learn how to knit in an afternoon and have a garment made up by bedtime. Would it sell, I highly doubt it. But I could wear it and someone else could wear it as well.
    Were you under an erroneous impression that you were saying something relevant?
    Ideas may be free, but new science isn't, whether your in a Communist, Mixed, or anarcho capitalism economy. A company who invest 20 million to develop a new drug will never recoup their losses if someone can create a generic for 5 million.
    Wrong. If their new drug has merit, they can easily make enough to pay for its development by being first into the market. Remember, the generic maker isn't a fool. He is not going to invest the $5M before he sees the market is viable. By that time, the originator has made back his investment.



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  3. #92

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    Quote Originally Posted by Zippyjuan View Post
    Drugs are actually an excellent example of patents encouraging development and innovation.
    Already refuted.
    It can cost millions or even billions to research new drugs and if the company is not able to have some protection for a limited time then a competiting company- who did not face those costs- can put out a copy of their own.
    In most cases, those drugs should not be developed. They are often no better than the off-patent generics, so in most cases the drug's development is nothing but a huge, wasteful rent-seeking exercise.
    Even if their cost of producing is the same, since they don't have the development costs, the competition makes more money off each one than the discoverer does- they only have the production and distribution costs to bear.
    Wrong. R&D is a sunk cost. The generic maker is going to wait until the market is proved profitable, by which time the developer has recouped some or all of that cost.
    Again, why go to the expense of researching new drugs if it is going to cost you money you cannot recover?
    Because you are smarter than ZJ, and realize that researching new drugs is done by scientists, not businessmen or banksters, and the latter really have very little reason to be involved if they can't make monopoly profits from it.
    Generics are cheaper precisely because they don't include R&D expenses.
    Garbage. R&D is a sunk cost all round. It's MARKETING that causes the brand-name versions to be so expensive. Generics are cheaper because of COMPETITION.

  4. #93

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    Chinese traditional medicine has survived 5,000 years without the FDA. With all the regulations out there, western medicine still hasn't caught up with CTM. My guess is the FDA is providing much of a benefit.

    China actually produces a much better quality of herbs than the U.S. and other capitalist countries. Because China has the death penalty there, they can't just throw in bogus stuff in their pills and claim its something its not. The acupuncturist I went to only purchased herbs from China for just this reason.
    I'm late in replying to this, but the claims you're making above are ridiculous. Was this written in jest? Chinese medicine is the most prominent example of quackery and "faith based" medicine in the world. Here, eat some tiger p*nis to make your more virile! What's the proof? Oh.. there is none. There are two kinds of medicine: evidence based, and not. Traditional chinese medicine is not grounded in science. And to make the claim that western medicine hasn't caught up to Chinese medicine is absurd. Which countries have the longest lifespans and illness survival rates again? Hint: It's not China. As for China having a "death penalty for putting bogus stuff in their pills and claiming it's something it's not" - there is no truth to this whatsoever. Didn't you read what I wrote in my post you quoted about Chinese manufacturers putting powdered baby flesh in capsules and selling it as a cure-all? I'm sorry, but you've been fed a pack of lies by your acupuncturist.

    There is medicine that works and medicine that doesn't. Herbal medicine as a whole does not. Virtually all medicine that works is grounded in science and evidence-based studies such as those that the FDA requires be performed, while virtually all herbal medicine is pedaled by charlatans that don't know if their pills work and don't care if they work, because they will be able to sell them either way, and people will genuinely feel they are being helped by such pills even when they aren't, thanks to the placebo effect. The harm that herbal medicine has done to this country in the case of serious illnesses by preventing or delaying people from seeking out science based treatments that work in favor of what amounts to faith healing and voodoo is immeasurable.
    Last edited by Knighted; 05-12-2012 at 01:21 AM.

  5. #94

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    Quote Originally Posted by Knighted View Post
    I'm late in replying to this, but the claims you're making above are ridiculous. Was this written in jest? Chinese medicine is the most prominent example of quackery and "faith based" medicine in the world. Here, eat some tiger p*nis to make your more virile! What's the proof? Oh.. there is none. There are two kinds of medicine: evidence based, and not. Traditional chinese medicine is not grounded in science. And to make the claim that western medicine hasn't caught up to Chinese medicine is absurd. Which countries have the longest lifespans and illness survival rates again? Hint: It's not China. As for China having a "death penalty for putting bogus stuff in their pills and claiming it's something it's not" - there is no truth to this whatsoever. Didn't you read what I wrote in my post you quoted about Chinese manufacturers putting powdered baby flesh in capsules and selling it as a cure-all? I'm sorry, but you've been fed a pack of lies by your acupuncturist.

    There is medicine that works and medicine that doesn't. Herbal medicine as a whole does not. Virtually all medicine that works is grounded in science and evidence-based studies such as those that the FDA requires be performed, while virtually all herbal medicine is pedaled by charlatans that don't know if their pills work and don't care if they work, because they will be able to sell them either way, and people will genuinely feel they are being helped by such pills even when they aren't, thanks to the placebo effect. The harm that herbal medicine has done to this country in the case of serious illnesses by preventing or delaying people from seeking out science based treatments that work in favor of what amounts to faith healing and voodoo is immeasurable.
    I generally don't speak about something unless I know what I am talking about. I would suggest you do the same. I've had plenty of experience going to doctors and acupuncturists, I know what each is capable of and how much science is based on it. You don't. For example, an acupuncturist can notice the slightest changes in your condition just by looking at your tongue. Doctors rely on bullshit statistics which tell you things like 25% of the people who took pill x got diabetes or if you have the xyz condition you have a 10% chance of death. Its nothing exact with doctors. Its all based on bullshit statistics as opposed to acupuncturists which are based on fact. Lets not forget, doctors have yet to develop a cure for anything, while acupuncturists have been curing most conditions for 5,000 years.

    And CTM has nothing to do with faith. Its 100% based on science.

    Exactly how many acupuncturists have you been to? How many practiced CTM? I've been to dozens of doctors. All they ever do is give me the run around and tell me I'm perfectly healthy based on the fact that I'm still alive, and nothing else.
    Last edited by tttppp; 05-12-2012 at 01:31 AM.

  6. #95

  7. #96
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    The generic maker is going to wait until the market is proved profitable, by which time the developer has recouped some or all of that cost.
    Exactly. The company who develops the original drug takes all the risks and has to pay the expenses for research. The generic maker only has to copy the formula from the original company. The original maker then has 20 years (from the time they file for the patent- not from when they start making the product- if the testing and aproval period takes ten years then they only have ten left to get those costs back) to try to recoup those costs. And without them spending those R&D costs and developing the drug in the first place, the generic companies would have nothing to copy or would have to spend their own money on R&D to come up with their own products.
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  8. #97

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    Quote Originally Posted by Zippyjuan View Post
    The company who develops the original drug takes all the risks and has to pay the expenses for research.
    Garbage. Almost all drug patents are based on research conducted at the expense of governments, foundations, universities, etc.

    And even without patents, the company that develops it gets to market it first, establishing a brand.
    The generic maker only has to copy the formula from the original company.
    More garbage. It also has to sell it cheaper than competing generics. That is far from easy or guaranteed, so they are also taking risks and shouldering expenses to bring the drug to the market.
    The original maker then has 20 years (from the time they file for the patent- not from when they start making the product- if the testing and aproval period takes ten years then they only have ten left to get those costs back) to try to recoup those costs.
    Which puts them under pressure to get as many prescriptions for it written as possible in that time, whether or not it is safe, effective, or better than public domain drugs for the same conditions.
    And without them spending those R&D costs and developing the drug in the first place, the generic companies would have nothing to copy or would have to spend their own money on R&D to come up with their own products.
    You're not paying attention. If all drugs are generic, the only way to get an advantage on competitors or make any money is to produce a new drug they aren't producing yet. Competition will wring out the profits of companies that only copy drugs others have developed.

  9. #98

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    Garbage. Almost all drug patents are based on research conducted at the expense of governments, foundations, universities, etc.
    Really? Pfizer, a single pharmaceutical company recently had $2 billion in R&D expenses. That's just one company alone. While it's true that some drugs are ultimately developed based upon findings from third party funded sources, they aren't simply handing big pharma companies a blank check. There is an incredible amount of research, development, and risk that these companies take on when developing a new drug.

    Which puts them under pressure to get as many prescriptions for it written as possible in that time, whether or not it is safe, effective, or better than public domain drugs for the same conditions.
    This is where the FDA comes in - requiring that companies prove the efficacy of new medications through rigorous, controlled studies. The FDA requirements aren't perfect by any means, but they are better than the alternative (which would be -no- studies done whatsoever on efficacy, side effects, and drug interactions - see the herbal supplement market for a prime example)

    You're not paying attention. If all drugs are generic, the only way to get an advantage on competitors or make any money is to produce a new drug they aren't producing yet. Competition will wring out the profits of companies that only copy drugs others have developed.
    Without drug patent laws, companies would be built from the ground up solely to copy the ideas that big pharma firms have invested time/research in and quickly reproduce/mass market them with minimal expense. What do you think would happen to a company like Pfizer, which is currently spending $2 billion a year on R&D costs to develop drugs, if drug patent laws were removed and random company Big China Drug Copiers (BCDC) Inc rolled into America to set up shop? Any new drug that Pfizer spends millions/billions on researching would immediately be duplicated in a lab by BCDC, ridiculously undercut in price to be just barely profitable (BCDC doesn't need much profit margin, since they are only spending a pittance on their own R&D), and thrown onto every shelf in America as the massively cheaper alternative. Sounds great at first, when drug prices sink like a rock, but the future doesn't look so rosy. Pfizer would be losing money hand over fist, and I can guarantee you that their R&D expenditures would dry up practically overnight as new drug development suddenly became a massive money losing proposition. Innovation and new development would grind to a halt, and the new drug market in the US would virtually disappear.

  10. #99

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    Quote Originally Posted by Knighted View Post
    Without drug patent laws, companies would be built from the ground up solely to copy the ideas that big pharma firms have invested time/research in and quickly reproduce/mass market them with minimal expense.
    That's the company I would build.

  11. #100

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    Quote Originally Posted by Travlyr View Post
    That's the company I would build.
    ROTFL! You'd lose your shirt, because every other economic know-nothing would be doing the same thing. Try to find a willingness to know: you can't get any market advantage that way.

  12. #101

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    Quote Originally Posted by Roy L View Post
    ROTFL! You'd lose your shirt, because every other economic know-nothing would be doing the same thing. Try to find a willingness to know: you can't get any market advantage that way.
    If it wasn't illegal to do, I would have started making generic Viagra years and years ago. I'd sell them for $1 a pill because I did not incur any R&D cost. Sure competition would be tough, but Pfizer wouldn't be able to sell it for that.

    You think I would lose my shirt. I think I could sell millions of them.

  13. #102

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    Quote Originally Posted by Knighted View Post
    Really?
    Yes.
    Pfizer, a single pharmaceutical company recently had $2 billion in R&D expenses.
    And it was almost all devoted to finding ways to get patents on existing drugs by using new methods of administering them, treating new conditions, etc. Drug company R&D has nothing to do with developing new or better drugs. It is exclusively focused on getting patents. They don't care about anything else, and they don't do the basic science that results in new drugs being discovered.
    That's just one company alone. While it's true that some drugs are ultimately developed based upon findings from third party funded sources, they aren't simply handing big pharma companies a blank check.
    Yes, they are.
    There is an incredible amount of research, development, and risk that these companies take on when developing a new drug.
    You misspelled, "getting drug patents." Google "rent seeking behavior" and start reading.
    This is where the FDA comes in - requiring that companies prove the efficacy of new medications through rigorous, controlled studies. The FDA requirements aren't perfect by any means, but they are better than the alternative (which would be -no- studies done whatsoever on efficacy, side effects, and drug interactions - see the herbal supplement market for a prime example)
    It would cost society 1/10 as much, and result in 10 times more really worthwhile new drug discoveries, if patents were eliminated and the necessary drug research was funded by government, universities, etc. based on scientific and medical rather than financial considerations. Medicare gives the government a huge financial incentive to fund research that results in truly new, effective, safe and cheap drugs, and it could do the job far better than private rent-seeking operations at a fraction of the cost of the drug patent system.
    Without drug patent laws, companies would be built from the ground up solely to copy the ideas that big pharma firms have invested time/research in and quickly reproduce/mass market them with minimal expense.
    That is one stupid-@$$ business model, my friend. You'd be competing with every other jerk-off against an established brand with a reputation for quality and safety.
    What do you think would happen to a company like Pfizer, which is currently spending $2 billion a year on R&D costs to develop drugs, if drug patent laws were removed and random company Big China Drug Copiers (BCDC) Inc rolled into America to set up shop?
    They would focus on providing value for money rather than rent seeking.
    Any new drug that Pfizer spends millions/billions on researching would immediately be duplicated in a lab by BCDC, ridiculously undercut in price to be just barely profitable (BCDC doesn't need much profit margin, since they are only spending a pittance on their own R&D), and thrown onto every shelf in America as the massively cheaper alternative.
    Does that happen in the fashion industtry?
    Sounds great at first, when drug prices sink like a rock, but the future doesn't look so rosy.
    It looks fantastic.
    Pfizer would be losing money hand over fist, and I can guarantee you that their R&D expenditures would dry up practically overnight as new drug development suddenly became a massive money losing proposition.
    "Research" on rent seeking SHOULD dry up overnight. It's wasteful.
    Innovation and new development would grind to a halt, and the new drug market in the US would virtually disappear.
    HAS THAT HAPPENED IN THE FASHION INDUSTRY???

  14. #103

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    Quote Originally Posted by Travlyr View Post
    If it wasn't illegal to do, I would have started making generic Viagra years and years ago. I'd sell them for $1 a pill because I did not incur any R&D cost. Sure competition would be tough, but Pfizer wouldn't be able to sell it for that.
    Sure they would. They were in the market first, they have the brand, they have production all set up.
    You think I would lose my shirt. I think I could sell millions of them.
    <yawn> Then why aren't you making millions in the fashion industry by producing knock-offs and selling millions of them cheaper than the fashion houses, hmmmmmmmmm?

    You need to stop typing and start thinking.

  15. #104

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    Quote Originally Posted by Roy L View Post
    Sure they would. They were in the market first, they have the brand, they have production all set up.

    <yawn> Then why aren't you making millions in the fashion industry by producing knock-offs and selling millions of them cheaper than the fashion houses, hmmmmmmmmm?

    You need to stop typing and start thinking.
    R&D for the fashion industry =/= R&D for the drug industry

  16. #105

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    Quote Originally Posted by Roy L View Post
    Medicare gives the government a huge financial incentive to fund research that results in truly new, effective, safe and cheap drugs, and it could do the job far better than private rent-seeking operations at a fraction of the cost of the drug patent system.
    Having been stuck in the government health care system due to disability before, I can tell you that this is not true. Cost control is terrible-and usually quality is as well. The rest of your post is spot-on.
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  17. #106

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    Quote Originally Posted by Knighted View Post
    This is where the FDA comes in - requiring that companies prove the efficacy of new medications through rigorous, controlled studies. The FDA requirements aren't perfect by any means, but they are better than the alternative (which would be -no- studies done whatsoever on efficacy, side effects, and drug interactions - see the herbal supplement market for a prime example)

    Once again, I don't think you know what you are talking about. CTM has survived thousands of years without anything like the FDA. Its much safer than the chemicals drug companies sell you. Even if you want to compare the American herb companies (that know nothing about herbs) to the drug companies, their herbs aren't any more dangerous than the chemicals drug companies sell. So whats the point of the FDA?

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    Originally Posted by Roy L

    And it was almost all devoted to finding ways to get patents on existing drugs by using new methods of administering them, treating new conditions, etc. Drug company R&D has nothing to do with developing new or better drugs. It is exclusively focused on getting patents. They don't care about anything else, and they don't do the basic science that results in new drugs being discovered.
    Perhaps you can explain for us how new drugs come into being if all the drug companies are doing is repatenting the same old thing over and over. That would leave us with 20,000 forms of asprin.

    http://www.forbes.com/sites/matthewh...ing-new-drugs/

    The Truly Staggering Cost Of Inventing New Drugs
    The range of money spent is stunning. AstraZeneca has spent $12 billion in research money for every new drug approved, as much as the top-selling medicine ever generated in annual sales; Amgen spent just $3.7 billion. At $12 billion per drug, inventing medicines is a pretty unsustainable business. At $3.7 billion, you might just be able to make money (a new medicine can probably keep generating revenue for ten years; invent one a year at that rate and you’ll do well).

    There are lots of expenses here. A single clinical trial can cost $100 million at the high end, and the combined cost of manufacturing and clinical testing for some drugs has added up to $1 billion. But the main expense is failure. AstraZeneca does badly by this measure because it has had so few new drugs hit the market. Eli Lilly spent roughly the same amount on R&D, but got twice as many new medicines approved over that 15 year period, and so spent just $4.5 billion per drug.
    Last edited by Zippyjuan; 05-13-2012 at 04:30 PM.
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  19. #108

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    Quote Originally Posted by Travlyr View Post
    R&D for the fashion industry =/= R&D for the drug industry
    Were you under an erroneous impression that you were saying something relevant? If anything, the fashion industry is even MORE dependent on bringing out new products than the drug industry -- which, FYI, spends far more on marketing than it does on research, just as one would expect from a rent seeking operation.

    By any reasonable measure, drug patents have become a rampaging, indefensible monster, much like the War on Drugs.

  20. #109

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    Quote Originally Posted by Zippyjuan View Post
    Perhaps you can explain for us how new drugs come into being if all the drug companies are doing is repatenting the same old thing over and over.
    Research funded by governments, universities, foundations, etc.
    That would leave us with 20,000 forms of asprin.

    http://www.forbes.com/sites/matthewh...ing-new-drugs/
    You don't get it. That is one of the characteristics of rent seeking behavior: it tends to grow to absorb the entire available rent. So the more money we throw at patented drugs, the more money will be spent obtaining drug patents -- and there is no expectation whatever that this increased spending will actually lead to better drugs. Think of what it would cost to buy a government-issued license to steal.

    GET IT??

  21. #110

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    Quote Originally Posted by heavenlyboy34 View Post
    Having been stuck in the government health care system due to disability before, I can tell you that this is not true. Cost control is terrible-and usually quality is as well. The rest of your post is spot-on.
    Unfortunately, Medicare is caught up in the rent-seeking paradigm: it's a huge source of unearned income for drug companies as well as hospitals, doctors, etc. Remove the rent seeking, and healthy incentives can operate.

  22. #111

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    Quote Originally Posted by Roy L View Post
    Were you under an erroneous impression that you were saying something relevant? If anything, the fashion industry is even MORE dependent on bringing out new products than the drug industry -- which, FYI, spends far more on marketing than it does on research, just as one would expect from a rent seeking operation.

    By any reasonable measure, drug patents have become a rampaging, indefensible monster, much like the War on Drugs.
    Lol... RoyL have you seen the fashion people actually wear in real life? Sure the privileged people may wear something of "fashion" from time to time on Sundays ... especially Hollywood wonders... but almost everybody I see wears T-Shirt and jeans perhaps shorts. Except for magazines and movie stars, the fashion industry is virtually non-existent.

  23. #112

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    Quote Originally Posted by Travlyr View Post
    Lol... RoyL have you seen the fashion people actually wear in real life? Sure the privileged people may wear something of "fashion" from time to time on Sundays ... especially Hollywood wonders... but almost everybody I see wears T-Shirt and jeans perhaps shorts. Except for magazines and movie stars, the fashion industry is virtually non-existent.
    Actually, that's not true. Even middle class/"poor" folks will pay an obscene amount of money just to have a nice logo on their clothes. In the fashion industry, small companies can make look-alike, "generic" clothes at a fraction of the price without paying royalties. Ever heard of stores like "Ross"? They specialize in these sort of clothes-"same quality, a fraction of the price" and the like as their mottos.
    Last edited by heavenlyboy34; 05-13-2012 at 11:07 PM.
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  24. #113

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    Quote Originally Posted by Travlyr View Post
    Lol... RoyL have you seen the fashion people actually wear in real life?
    Yes.
    Sure the privileged people may wear something of "fashion" from time to time on Sundays ... especially Hollywood wonders... but almost everybody I see wears T-Shirt and jeans perhaps shorts.
    That may say more about the company you keep than about the fashion industry.
    Except for magazines and movie stars, the fashion industry is virtually non-existent.
    No, that is just absurdity from you. You couldn't have so many clothing stores in the malls to sell the products of a non-existent industry. Just the volume of advertising alone -- check any magazine stand -- proves the fashion industry is large and dynamic.

  25. #114

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    Post pictures of the fashionable clothes people are wearing in your area. In my area it is jeans, T-shirts, and boots on girls... jeans, T-shirts, and tennis shoes on guys.

  26. #115

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    Quote Originally Posted by Travlyr View Post
    Post pictures of the fashionable clothes people are wearing in your area. In my area it is jeans, T-shirts, and boots on girls... jeans, T-shirts, and tennis shoes on guys.
    The plural of "anecdote" is not "data."

  27. #116

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    It would cost society 1/10 as much, and result in 10 times more really worthwhile new drug discoveries, if patents were eliminated and the necessary drug research was funded by government, universities, etc. based on scientific and medical rather than financial considerations. Medicare gives the government a huge financial incentive to fund research that results in truly new, effective, safe and cheap drugs, and it could do the job far better than private rent-seeking operations at a fraction of the cost of the drug patent system.
    So you believe that money used in grant-based medical research, which is coming out of some anonymous donor's pockets and is taken and distributed at some "administrator's" behest, is going to be better and more wisely spent than money left in private hands with a profit incentive? If you believe that, then you must also believe that money taken from taxpayer's pockets and spent by government bureaucrats will be more wisely spent than money left in private hands. I hate to tell you, but history isn't on your side on that one. Who's going to choose to spend more wisely? A group given a bag of money and told "Do with it what you want to develop drugs - it's free" or a group given a bag of money, some of which is their own, and told that if they don't develop a successful drug, their money is gone - and if they do develop one, their money will triple?

    >>Without drug patent laws, companies would be built from the ground up solely to copy the ideas that big pharma firms have invested time/research in and
    >>quickly reproduce/mass market them with minimal expense.
    That is one stupid-@$$ business model, my friend. You'd be competing with every other jerk-off against an established brand with a reputation for quality and safety.
    Oh really? What if it's, say, AstraZeneca (or any other prominent drug company) that already has a strong reputation built up and the stringent quality and safety controls already needed. If you take away patents, what's stopping Astra from capitalizing on Pfizer's research and quickly mass producing identical pills the moment Pfizer's drug hits the shelves? AstraZeneca wouldn't even need to spend R&D to develop drugs any longer - it would be more profitable to simply poach competitor's products. Q: What happens when drug companies can no longer capture back in profit the money they spent in R&D? A: They quit spending money on R&D. Innovation dies.
    Last edited by Knighted; 05-15-2012 at 04:56 PM.

  28. #117

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    Quote Originally Posted by Travlyr View Post
    Post pictures of the fashionable clothes people are wearing in your area. In my area it is jeans, T-shirts, and boots on girls... jeans, T-shirts, and tennis shoes on guys.
    Head on down to your local mall and find some fashion stores (not the chain stores, the local ones) and see for yourself.
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  29. #118

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    Quote Originally Posted by Knighted View Post
    Oh really? What if it's, say, AstraZeneca (or any other prominent drug company) that already has a strong reputation built up and the stringent quality and safety controls already needed. If you take away patents, what's stopping Astra from capitalizing on Pfizer's research and quickly mass producing identical pills the moment Pfizer's drug hits the shelves? AstraZeneca wouldn't even need to spend R&D to develop drugs any longer - it would be more profitable to simply poach competitor's products. Q: What happens when drug companies can no longer capture back in profit the money they spent in R&D? A: They quit spending money on R&D. Innovation dies.
    Makers of generics would've already undercut pharma developers if you really believe what you're saying-and big pharma would already be out of business, no longer making drugs. Why are supplement makers doing so well? They can't patent their products at all even though they do as much work in R&D or more as the pharma corps do.
    Last edited by heavenlyboy34; 05-15-2012 at 05:06 PM.
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  30. #119

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    Makers of generics would've already undercut pharma developers if you really believe what you're saying-and big pharma would already be out of business, no longer making drugs.
    Uh, no. Please go back and re-read the post you're replying to. This whole discussion has been about the hypothetical scenario of patent protections being removed from drugs. The reason that undercutters (generic producers) do not drive big pharma out of business today is BECAUSE of patent protections which grant the typical company 7-12 years of relatively competition-free sales to recoup the enormous R&D expenditures that they put forth to develop a drug. Take that away, and R&D expenditures will dry up virtually overnight, and so will new drug development. That is the precise topic of discussion here.

    Why are supplement makers doing so well? They can't patent their products at all even though they do as much work in R&D or more as the pharma corps do.
    Supplement makers are doing well because they can slap a label on anything and throw anything into a capsule and cleverly market it as the next cure-all - they can't come right out and call it a cure-all due to the FDA's laws, but they can still convince consumers that it is one through deceptive wording. As to supplement makers spending as much in R&D as big pharma? That's frankly absurd. Name one supplement maker that has R&D expenditures anywhere near a big pharma company. Most supplement manufacturers don't spend a dime on R&D. They don't need to in order to sell their product. And if they did go to the trouble of spending massive R&D dollars on it, they would simply get FDA approval and market it mainstream as a cure. Unfortunately, upwards of 95% of herbal market products are nothing more than placebos (if not actually detrimental), and that's precisely why they are marketed as supplements and not full fledged drugs with science backed evidence behind them. And it's a widespread myth that "herbal" treatments can't be patented. Over 25% of all mainstream, FDA-approved pharmaceutical drugs originate from some natural plant source.
    Last edited by Knighted; 05-15-2012 at 10:55 PM.

  31. #120

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    Quote Originally Posted by Knighted View Post
    Supplement makers are doing well because they can slap a label on anything and throw anything into a capsule and cleverly market it as the next cure-all - they can't come right out and call it a cure-all due to the FDA's laws, but they can still convince consumers that it is one through deceptive wording. As to supplement makers spending as much in R&D as big pharma? That's frankly absurd. Name one supplement maker that has R&D expenditures anywhere near a big pharma company. Most supplement manufacturers don't spend a dime on R&D. They don't need to in order to sell their product. And if they did go to the trouble of spending massive R&D dollars on it, they would simply get FDA approval and market it mainstream as a cure. Unfortunately, upwards of 95% of herbal market products are nothing more than placebos (if not actually detrimental), and that's precisely why they are marketed as supplements and not full fledged drugs with science backed evidence behind them. And it's a widespread myth that "herbal" treatments can't be patented. Over 25% of all mainstream, FDA-approved pharmaceutical drugs originate from some natural plant source.
    You've been mislead by government health org propaganda.

    For years, dietary supplements have been scrutinized by the media for being marketed as “snake-oil” cure-alls, potentially containing components considered harmful to consumers. Under-regulation by the Food and Drug Administration (FDA) lead to concerns that these products did not fall under the same regulatory requirements as pharmaceuticals. Until now.


    New FDA regulations for the dietary supplement industry aim to eradicate consumer concern and health risks associated with these products. Dietary supplement manufacturers and distributors are now required to follow Good Manufacturing Practices (GMPs) similar to those of the pharmaceutical industry. The FDA 21 Code of Federal Regulations (CFR) Part 111 was established to insure the identity, purity, quality, strength, and composition of dietary supplements and applies to those involved in the manufacture, packaging, labeling or holding of a dietary supplement, with the exception of retail establishments selling directly to consumers.
    The federal government is taking a tiered approach to enforcement: companies with more than 500 employees were required to become compliant by June 2008; companies with 21-499 employees must become compliant before June 2009; and companies with fewer than 20 employees will need to be compliant by 2010.
    To become compliant with the GMP guidelines, passed in 2007, dietary supplement companies need to perform analytical testing of their products. Analytical laboratory analysis falls under the category of “manufacture” as defined by FDA CFR. Therefore, if testing is not performed the dietary supplement company will be considered non-compliant regardless of the reason for not testing. Reasons for not testing range from it being cost prohibitive to it’s impossible as an option for raw materials, in-process or final products. Those non-compliant and unable to meet GMP guidelines will run the risk of not being able to sell their products due to regulatory agency action. This may result in some companies going out of business or, at the least, an increased need for analytical testing.
    In some ways, GMPs for dietary supplements have been considered to be more strict than those for pharmaceuticals. For example, many pharmaceutical compounds can be considered “pure” if they meet 90-98 percent of the requirement. Purity constraints for dietary supplements can be as much or more than 100 percent as a requirement. The GMPs for dietary supplements are a combination of GMPs for both food and drugs. The abundance of new regulations may be a response to the public scrutiny the dietary supplement industries have received in recent years.

    GMP compliant analytical testing for GMP guidelines may include residual solvent and heavy metals analysis, water determination by Karl Fischer, and microbial limit testing. These tests are designed to ensure product quality and consumer safety, but there is a need for identity testing and potency as well. Identity and potency will confirm for manufacturers that the product label accurately reflects the actual ingredients as well as potency of each batch or lot of product. In other words, “it is what it is” and the manufacturer has the compliant analytical quality control laboratory documentation to prove it.
    This new challenge for production will require substantial new testing in order to maintain compliance. Some dietary supplement companies have already found that outsourcing the testing, though thousands of dollars per year, is a more sensible business strategy than investing millions developing and maintaining their own compliant laboratories. When outsourcing analytical testing to laboratories, the FDA requires the outside lab to be cGMP compliant and FDA inspected. The Quality Unit of compliant laboratories will be able to readily supply information including documentation of quality systems and FDA inspection reports.
    Manufacturers may want to assess the most cost effective and efficient means to deal with these new FDA regulations.
    - – -
    References:
    FDA Issues Dietary Supplements Final Rule
    http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html


    FDA 21 CFR part 111
    http://www.accessdata.fda.gov/script...11&showFR=1FDA
    For years, dietary supplements have been scrutinized by the media for being marketed as “snake-oil” cure-alls, potentially containing components considered harmful to consumers. Under-regulation by the Food and Drug Administration (FDA) lead to concerns that these products did not fall under the same regulatory requirements as pharmaceuticals. Until now.
    Quote Originally Posted by Ron Paul
    The government is incapable of doing what it's supposed to do. A job like the provision of security is something best left to private institutions.
    My music/art page is here"government is the enemy of liberty"-RP
    That which doesn't kill me has made a grave tactical error
    Quote Originally Posted by Anti Federalist View Post
    This whole board is a thoughtcrime in progress.
    Quote Originally Posted by danke View Post
    I carry my man purse for fashion, not function.

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