Are The FDA & The Patent System Getting In The Way Of Saving Lives Again?

from the that-market-ain't-free dept

There was a somewhat horrifying article in the NY Times recently about some serious drug shortages in the US, especially for certain forms of cancer. There are a few efforts underway to deal with the shortages, but as the article notes, it's pretty ridiculous that there are any shortages at all, since "the number of cancers diagnosed in a year was easy to predict." Of course, the real problem is that in a claimed effort to "protect" people, the FDA has made it almost impossible for competition to exist:
A crucial problem is disconnection between the free market and required government regulation. Prices for many older medicines are low until the drugs are in short supply; then prices soar. But these higher prices do little to encourage more supply, because it can be difficult and expensive to overcome the technical and regulatory hurdles. And if supplies return to normal, prices plunge.
Left out of this paragraph, but equally important, are patents, which clearly hinder such competition as well. We've discussed in the past how the FDA can often get in the way of medical innovation. Even if it means well (and I'm sure it does), putting in place systems that make it too costly to create real competition does the exact opposite of its intended purpose.


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    That Anonymous Coward (profile), Aug 25th, 2011 @ 12:21am

    But the free market is best suited to regulate itself.

    When people are getting sicker and dying so a corporation can make more profit the system is screwed.

    Do we need to travel to DC and start stacking up body bags to get their attention? This is another step down a horrible path and while they seem to pay lip service to having the FDA look into these things, that have made the FDA as impotent to do anything as they possibly can.

    Maybe it is time to tie patents to orphaned drugs. Yep you get an exclusive patent on your new super drug, BUT you are required to keep producing X drug that people need at a regulated price. If you create an artificial scarcity for either drug to get more money your patent is rescinded or we auction it off to one of your competitors who will have the same restrictions.

    They like to forget that "the people" are stakeholders in these things as well. That we agreed to let them have the exclusive rights to profit from what they made, but when you screw with the market to inflate your profits at the expense of the health of the people you have gone to far.

    It is time to stop worrying about corporations well being. They have had everything they wanted given to them and it has benefited society as little as possible in exchange. It is time to rebalance the scales, and have oversight that keeps it balanced.

     

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    Suzanne Lainson (profile), Aug 25th, 2011 @ 12:23am

    Many problems with US health care

    The cost of health care in this country has to come down, or people can't afford it. I don't know if it will take people dying to lead to some action, but it's likely to get worse before it gets better.

    As long as lobbyists and politicians convince voters that we have the best health care system in the world and that any changes will hurt citizens, not much is going to happen.

    Anyone care to mount an effective campaign to get things turned around?

     

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    That Anonymous Coward (profile), Aug 25th, 2011 @ 2:50am

    As I have asked before, the rich understand if they kill us off they will have no one to do anything for them right?

    While they might just want lower costs for a nice yard, people dropping dead tend to make the place look a little drab.

     

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      Suzanne Lainson (profile), Aug 25th, 2011 @ 10:17am

      Re:

      As I have asked before, the rich understand if they kill us off they will have no one to do anything for them right?

      I have pondered this a lot. Do the masses have any leverage? Do we reach a tipping point where things get so bad for so many people that the very wealthy are moved to act?

      But my conclusion is that the masses don't have that leverage. The very wealthy can get by with far fewer people. In fact, it's probably better for the planet if we continue to have a worldwide recession. Consumption goes down, which reduces degradation of the planet.

      And if people die off, it's a crude form of population control.

      When companies made money from people borrowing and consuming, then having lots of consumers was a good thing for those corporate owners. But if consumers stop borrowing to pay off debt and buy less as a result, they don't contribute to the wealthy and therefore, other than for humanitarian reasons, the wealthy have no incentive to save them.

      If you look at politics in this country and around the world, you realize there are a lot people ready to eliminate funding on those programs that help the poor and the middle class.

       

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    Anonymous Coward, Aug 25th, 2011 @ 2:59am

    As there is not a free market in the USA with regard to drugs, IE. patents/regulatory issues, drug prices will continue to be high.

     

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      That Anonymous Coward (profile), Aug 25th, 2011 @ 3:09am

      Re:

      Well maybe "We the sick people" should work on getting every board member ill, and then go after congresscritters.

      They seem out of touch with reality, it would be nice for them to be told no sometimes. No we have nothing left that can treat you. We had some but we sold the last does on eBay to the highest bidder... and it wasn't you. Enjoy your fever.

       

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    Scooters (profile), Aug 25th, 2011 @ 3:22am

    US Chamber of Commerce Secret is revealed!

    This is why "her friend" went to one of "those sites" and paid the ultimate price for it.

    She couldn't get her drugs the legal way.

    Perhaps drug companies manufacture a pill that gives people a clue.

     

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    Thomas (profile), Aug 25th, 2011 @ 6:10am

    The FDA

    is too mired in bureaucracy to really care about people dying when it conflicts with the pharma companies that provide generous "gifts" to the FDA members. The patent office has zero interest in human health.

     

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    Ima Fish (profile), Aug 25th, 2011 @ 6:12am

    "FDA can often get in the way of medical innovation"

    It's pretty clear that the real purpose of the FDA is to protect the pharmaceutical gatekeepers.

     

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    Anonymous Coward, Aug 25th, 2011 @ 6:29am

    I shudder to think of the alternative, with the FDA "out of the way", and any recent grad with access to a PO pad and a pill machine knocking out generic drugs, without concern for accuracy, cleanliness, or efficacy of the resulting products, making them because they can make money.

    Yup, I want the FDA out of the way of the drug business, so that I can be sure that the standards in the US catches up with Mexico.

     

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      Chris Rhodes (profile), Aug 25th, 2011 @ 7:49am

      Re:

      Would you buy pills from some guy who makes them out of his living room? Why do you need the FDA to tell you that might not be a good idea?

      I know, I know, you would never do something like that. It's all the other stupid people out there that need your wise council on what is and isn't good for them.

      Good thing educated folks like you and the FDA are here to tell us what's what, or the unwashed masses would be stabbing themselves in the eyes with their forks and eating mud out of the gutter.

       

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        CarlWeathersForPres, Aug 25th, 2011 @ 7:53am

        Re: Re:

        I'd just start a dummy corporation and sell them on the internet so nobody could see my set up. I'm sure all the super smart insiders on the site could see through the internet while buying their cheap drugs to tell that I don't clean equipment thoroughly.

         

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          Chris Rhodes (profile), Aug 25th, 2011 @ 8:16am

          Re: Re: Re:

          Again, would you buy drugs from a no-name company over the internet?

          There is an important role for third-party evaluations and certifications in the market, but it doesn't have to be done by a massive government bureaucracy with the sole power to decide who can and can't sell their products, enforced by armed men who will kidnap you and throw you in cage for years at a time if you don't comply.

          The only support that can be mustered in favor of the FDA existing is disgusting mixture of "I'm smarter than the unwashed masses" elitism combined with "if the government doesn't do with guns, it will never be done" stupidity.

           

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            Anonymous Coward, Aug 25th, 2011 @ 8:39am

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            Chris, how do you know name from no-name?

            Have you considered what someone on a fixed income might do to save money? Dang, I can get my meds for half price from this place. I need the money to eat, so yeah, let's do it.

            People spend tens of millions of dollars on fake medication already with the FDA involved, can you imagine the free for all without them?

             

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              Chris Rhodes (profile), Aug 25th, 2011 @ 9:07am

              Re: Re: Re: Re: Re:

              Chris, how do you know name from no-name?

              History, mainly. Walgreens isn't going to sell a knock-off that kills their customers, if they can help it. In a market without the FDA, third-party certs would be invaluable.

              "Oh, Drug Underwriters Inc. signed off on their facilities. I know that no facility they've ever signed off on has released any contaminated pills, so that's a good endorsement."

              Dang, I can get my meds for half price from this place. I need the money to eat, so yeah, let's do it.

              So the answer is to make them so expensive through regulation, that those same people have to choose between eating and getting their meds? How does that help anyone?

              People spend tens of millions of dollars on fake medication already with the FDA involved

              And here we see that the failure of the system is used as evidence for why the system is needed. (Reminds me of arguments for the war on illegal drugs too, now that you mention it.) Maybe if people didn't believe that a benevolent dictator in a government office building would do their thinking for them, they'd start to do some themselves.

               

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                CarlWeathersForPres, Aug 25th, 2011 @ 9:13am

                Re: Re: Re: Re: Re: Re:

                Walgreens(and every other chain) sells Airborne, which is a placebo with no benefits whatsoever. It's a company that's been hit with multiple FDA fines, so they've had to change the advertising on the box so there are no real claims whatsoever (I think it says, "boosts immune system," which is code for "does nothing, but the FDA allows this wording because Orin Hatch is an idiot). Walgreens sells it because it makes them money. People by it because it's cleverly marketed, and guess what, their colds go away when they take it(forget the fact that their cold would go away if they didn't take it). This is just a case study, in my opinion, of what an entire market with "rational actors" would act like.

                Like I said, I think the system needs some fixing, but that doesn't mean to blow it up entirely.

                 

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                  Chris Rhodes (profile), Aug 25th, 2011 @ 9:27am

                  Re: Re: Re: Re: Re: Re: Re:

                  First off, you don't need the FDA to prosecute a company for fraud.

                  This is just a case study, in my opinion, of what an entire market with "rational actors" would act like.

                  As opposed to having the wise, learned elitists at the top to make decisions for us, you mean? Airborne is useless. I don't buy it, and I tell everyone I know that asks about it that it's useless. The thing is, I don't grab a gun, walk into a Walgreens, and threaten to hurt the clerk for selling it. (People forget that this is the entire purpose of the government; to threaten with violence. If you wouldn't do it yourself, why does it suddenly become acceptable and moral to pay someone else to do it for you?)

                  Like I said, I think the system needs some fixing, but that doesn't mean to blow it up entirely.

                  The FDA is not the system. The FDA is one particular leech on the system. Dynamiting the FDA is not blowing up the system entirely.

                   

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                    CarlWeathersForPres, Aug 25th, 2011 @ 10:08am

                    Re: Re: Re: Re: Re: Re: Re: Re:

                    The decisions that the FDA makes are:
                    Do the studies show what the manufacturer is claiming
                    Are there ill effects
                    Are the drugs not contaminated

                    That's it. And last I checked, the only time the FDA has done any type of physical incarceration is when people knowingly commit fraud, and it's usually top level execs who make the decision. Most of it is punitive damages, so I'm not really sure where your gun example comes into play, unless the supreme court has ruled that money = firearms, and I missed it.

                    Clearly you have issues with government, and I don't think I can change your (or anyone elses) mind about trusting government. I'm sorry you feel that way. Personally, knowing the people who do the work and their motives, I trust most of the underlings in what they do. Does it mean that there isn't corruption, of course not, but as I think I've pointed out, there's no such thing as a corruption free system.

                    It also looks like you have issues with trusting other people(learned elitists, which personally, I trust people who have spent their entire career studying something). I understand the sentiment(I don't trust profit maximizers), but in a world of specialization I can't know everything, so I have to put faith in something. To me, that something isn't that the uninhibited free market is the best mechanism to regulate company actions. I see the trade off as losing some freedom of choice in favor of the overall safety of the system, which I prefer. Just my opinion, so take it for what it's worth.

                    The system I'm talking about is a safe and effective drug market. Most of the things that create that system stem from FDA regs and oversight, IMO, so I think getting rid of the FDA would be like getting rid of Ghaddafi(although I'm not saying they are Ghaddafi, just that this is a very recent parallel to draw). Nobody knows what Libya will be like, there's been no entities that have existed without his oversight for 30 years. Does the vacuum create a more robust system, or does it devolve into chaos? Can the robust system fill in quick enough so that the chaos wouldn't ensue? These are questions that I'm not smart enough to answer, and I realize this, so I'll toss it over to you to fill me in.

                     

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                      Chris Rhodes (profile), Aug 25th, 2011 @ 10:22am

                      Re: Re: Re: Re: Re: Re: Re: Re: Re:

                      the only time the FDA has done any type of physical incarceration is when people knowingly commit fraud, and it's usually top level execs who make the decision. Most of it is punitive damages, so I'm not really sure where your gun example comes into play

                      Tell, me, what does the government do if you don't pay them? That's like saying a mugger isn't really committing a violent act if he asks for your money at gunpoint first, because he hasn't actually shot you yet to take it.

                      It also looks like you have issues with trusting other people

                      Not at all. What I have "issues" with is people telling me what I can and can't do with my own body. This man wants to sell me a pill; I want to buy the pill. Who are you or anyone else to threaten me with financial or bodily harm for doing it? And to make matters worse, you then tell me that you have to hurt me for my own good. I'd much prefer if it you and your ilk just stayed the hell out of my life, actually. I know you won't, though.

                      Violence is all anyone knows anymore, apparently.

                       

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                        CarlWeathersForPres, Aug 25th, 2011 @ 10:40am

                        Re: Re: Re: Re: Re: Re: Re: Re: Re: Re:

                        What does anyone do if you don't pay them? They find someone who is bigger than you to seize your assets. Whether it's the gov't or Dog the bounty hunter, the mechanisms are the same, so I don't see why we don't consider contract law as use of force to take money? I mean, if I say I'll paint your house and olny do 90% of it, and you pay me 40% of the money, isn't getting what I'm owed(or you getting what you're owed) another form of robbery(both of us don't feel that the scenario is right, so one of us is getting "robbed")? I'll tell you why we don't look at things like this, because that's an absurd proposition to say that equity is the same as robbing at gunpoint.

                         

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                          Chris Rhodes (profile), Aug 25th, 2011 @ 11:50am

                          Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re:

                          They find someone who is bigger than you to seize your assets.

                          Which apparently doesn't count as force, according to you?

                          consider contract law as use of force

                          Because contracts are voluntarily entered into,and if you don't hold up your end of the bargain, you've essentially stolen from the other party. Theft is force. I haven't signed any contract with the FDA, but will that prevent them from trying to hurt me if I don't follow their "recommendations"?

                          If a man wants to sell me a pill, and I want to buy it, the person who threatens to steal our property and throw us in jail are using unjust force to do it. There is no "equity" here. Just a bully with a lot of guns at his command.

                          The fact that the bully is a government bureaucrat that will no-doubt be later appointed to a big pharma executive position for his role in pushing people towards that company's expensive products over the cheaper alternatives while he was in office is immaterial to the analogy, but icing on the cake nonetheless.

                           

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                            CarlWeathersForPres, Aug 25th, 2011 @ 12:05pm

                            Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re:

                            When you enter certain fields, you agree to abide by the rules. It's part of being a member of society.

                            Just like with contracts, you decide that you want to enter the stream of commerce to solve a problem. You abide by all the rules of that stream of commerce. The contract example was one where 2 people were harmed, both felt that they had the right to something, and unfortunately someone was going to be forced to do something they didn't want. Sure, they assented to the original deal, but drug manufacturers and consumers assent through the democratic process.

                             

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                              Chris Rhodes (profile), Aug 25th, 2011 @ 12:16pm

                              Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re:

                              The democratic process is not a contract. The fact that people still believe this ridiculously silly canard is a testament to the undying propaganda of our school system.

                              Voting is force. It's always been force. We vote because we hope that the decisions to use force that come out of a democratic process will be better than the decisions to use force by a dictator, but that doesn't change the nature of the action. Actions do not lose their essential nature or become moral simply because a majority of voters command them into law.

                              A contract you don't agree to is not a contract.

                               

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                  PRMan, Aug 25th, 2011 @ 11:12am

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                  Not that I take Airborne at all, but:

                  • Are you saying that Vitamin C has no positive effect on the immune system? (NIH: "people who take vitamin C supplements regularly might have slightly shorter colds or somewhat milder symptoms.")

                  • Are you saying that Echinacea has no health benefits whatsoever? (NIH: "studies have shown that echinacea may be beneficial in treating upper respiratory infections.")

                  • Are you saying that taking more Zinc isn't a good thing? (The NIH says: "Zinc deficiency is characterized by growth retardation, loss of appetite, and impaired immune function.")

                  • So, Ginger has no cold-fighting effects? (NIH: "Other uses include treating upper respiratory tract infections, cough, and bronchitis.")

                  So, pretty much the FDA disagrees with the NIH on the effectiveness of Airborne.

                  Wake up. The FDA raids, fines and persecutes companies that sell vitamins and herbs because their drug company buddies don't want the competition from things with no side effects that can't be classified as drugs, even though they are effective.

                   

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                    Chris Rhodes (profile), Aug 25th, 2011 @ 11:54am

                    Re: Re: Re: Re: Re: Re: Re: Re:

                    Sorry, you don't get to make decisions for yourself based on your own research. Only Carl and his "expert" bureaucrats in Washington can make those decisions for you. You're just a stupid prole who would die in the streets without your betters to take care of you.

                    (And if you don't like it, prepare to get the shit kicked out of you by the government. It's not really violence, though, because the law says it's okay! Aren't we all so enlightened these days?)

                     

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                    CarlWeathersForPres, Aug 25th, 2011 @ 12:01pm

                    Re: Re: Re: Re: Re: Re: Re: Re:

                    Vitamin C has limited effect, and only if you take massive doses prior to the infection. Once the cold comes on there is no benefit.

                    Zinc does have effects, see Zycam. It shortens the length of colds through chemical means, and should be classified as a pharmaceutical. It also causes anosmia(loss of smell), but since Zycam was classified homeopathic(even though it wasn't).

                    As for the other 2, I don't have time to do the research(and doubt that there is any significant effect in large trials), but the post shows your lack of knowledge of the scientific process, and random trials. Just because a single study shows that something might occur, does not mean it's true. The reason the FDA didn't approve Airborne wasn't conspiracy, it was the fact that when they compared taking Airborne to taking a placebo, there was no measurable difference between the 2. This leads to the conclusion that if you take nothing and take Airborne and both have the same effect, then Airborne has no effect and should not market itself as having an effect.

                     

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                      Chris Rhodes (profile), Aug 25th, 2011 @ 12:07pm

                      Re: Re: Re: Re: Re: Re: Re: Re: Re:

                      Vitamin C has limited effect, and only if you take massive doses prior to the infection. Once the cold comes on there is no benefit.

                      I've always understood that you're supposed to take Airborne (which has a "massive" dose of Vitamin C in it) before going into a situation where you're likely to be exposed to sick people. That's why they call it Airborne (hint: you're supposed to take it before getting on a plane).

                      I tend to think it's a waste of money, but then, I don't think I should threaten people to stop them from buying and selling it either. I guess that's where we differ.

                       

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                    John Fenderson (profile), Aug 25th, 2011 @ 12:13pm

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                    Just to be a scientific pedant...

                    "boosting the immune system" is a largely meaningless phrase, on par with "encourages good health". "Boosting" is not defined, nor is "immune system" ("immune system" is a colloquial term, not a medical one. You have no "immune system", you have many different and distinct biological activities that are collectively needed to keep you alive.

                    (NIH: "people who take vitamin C supplements regularly might have slightly shorter colds or somewhat milder symptoms.")


                    In scientific papers, "might" means "neither proven nor disproved". In other words, when you read "might" you can safely ignore the rest of what "might" be, as the it adds nothing to your knowledge or understanding.

                    (NIH: "studies have shown that echinacea may be beneficial in treating upper respiratory infections.")


                    "May be" is just another was to say "might".

                    (The NIH says: "Zinc deficiency is characterized by growth retardation, loss of appetite, and impaired immune function.")

                    Taking more zinc can be very beneficial if you have a zinc deficiency. If you don't, then this statement in no way asserts that taking zinc has any benefit. Odds are that you don't have a zinc deficiency.

                    (NIH: "Other uses include treating upper respiratory tract infections, cough, and bronchitis.")


                    This is only a statement of what people use use ginger for, not of whether or not it's effective for these uses.

                    So, all in all, these quotes do not support the idea that the FDA and the NIH disagree about the effectiveness of Airborne.

                    Where Airborne got into trouble was in making health claims that were not supported by the evidence. None of these quotes counter that conclusion.

                     

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            CarlWeathersForPres, Aug 25th, 2011 @ 8:53am

            Re: Re: Re: Re:

            I have no idea how I'd act in a deregulated market, but I know that I routinely find the lowest priced good on the market, irrespective of . And honestly, I need the FDA. For background, I have a ChemE degree, have done modeling work with Chemo drugs, and read multiple drug blogs which keep me "sharp". I still don't feel confident that I have the ability to make rational decisions, partly because I don't have a microscope to look at every drug coming through the market to check for biological contaminants or that I'm able to go through volumes of phase 1, 2, 3 and 4 studies which tease out all the side effects. And the other misconception is that if the laws went away, the big companies(that are getting killed now) would continue to produce high level goods (so we would continue to patron them) or do the same amount of work to check efficacy and side effects. I think it's extreme hubris to think that I could personally make rational choices without the data the FDA requires, the equipment, time and access to check facilities or even the technical know how to evaluate some of the newer drugs that will be coming onto the market(e.g. the use of virus particles to direct action to a site). If you can do all these things, I applaud you.

            As for 3rd party evaluators, doesn't this put us in the same exact situation? Why does anyone think that there would be less corruption in a third party system? For example, look at Standard and Poor's rating of the high risk bonds from a few years ago. They were essentially being paid off to give good scores to the bonds(and causing a collapse), and their opinion is still high enough that when they downgrade the US's credit rating everyone takes it seriously. Why would drugs be any different?

            Do I agree that there are inefficiencies in the system? Absolutely. Do I think that doing away with the system is a better solution? No way. If you think I'm making a fatal flaw in reasoning, please let me know, but I think the FDA is one of the few governmental entities that is actually necessary.

             

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              Chris Rhodes (profile), Aug 25th, 2011 @ 9:19am

              Re: Re: Re: Re: Re:

              I still don't feel confident that I have the ability to make rational decisions, partly because I don't have a microscope to look at every drug coming through the market to check for biological contaminants or that I'm able to go through volumes of phase 1, 2, 3 and 4 studies which tease out all the side effects.

              You don't necessarily have to, as long as you make the choice to buy goods with a reputable third-party cert. I wouldn't buy a copy of every car I'm interested in just to crash test it myself, for example.

              As for 3rd party evaluators, doesn't this put us in the same exact situation? Why does anyone think that there would be less corruption in a third party system?

              There would undoubtedly still be corruption, but the key point is that no third-party cert company would have the power to outright ban products that they didn't certify. With the FDA, you have a huge problem with regulatory capture, whereby the incestuous relationship between corporate profits and government force scheme to keep out competitors so that they can extract monopoly rents from citizens.

              In a free system, I can choose to patronize an ethical company over an unethical one. Tell me, who can I choose to give my business to if the FDA is the corrupt one?

               

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                CarlWeathersForPres, Aug 25th, 2011 @ 9:46am

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                Honestly, I still don't think a third party cert and free market principles can create enough in punitive damages of good will to deter companies from acting like they are (although, I'm extremely cynical of large companies trying to maximize profit). Like the example I gave above, there's nothing in our lexicon now that tells me 3rd party certs can be reliably trusted for all issues. At least with the FDA there is enough bureaucracy that they can get things right most of the time.

                As for the current situation, we're in it because big pharma is subcontracting the work overseas where there is not the oversight and the FDA is catching the contaminants in the drugs. Sans the FDA, there would probably be deaths. In my opinion, since the drugs are off patent(see my post below), this is a manufacturing and capacity issue which the FDA has kind of exacerbated because it doesn't want medicine to kill the patients (although with chemo you're just adjusting the rate of killing the patient). This seems to be more analogous to what the system would be like without patents or FDA regs, a single company would manufacture in the cheapest place possible and would have the capacity to sell everything, essentially at cost. If they increased the price others would enter the market, but not quick enough to fix any drop in production rates. This isn't like the C. Allen Black case, which I think the FDA/NIH should have opened the patent up so others could manufacture it, this is a case where free market principles have made it so there is little to no incentive to enter the market.

                 

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                  Chris Rhodes (profile), Aug 25th, 2011 @ 10:26am

                  Re: Re: Re: Re: Re: Re: Re:

                  Honestly, I still don't think a third party cert and free market principles can create enough in punitive damages of good will to deter companies from acting like they are

                  You can still take those companies to court. If you sell me aspirin laced with botulism, you can bet there'd be a lawsuit coming your way. You don't need the FDA for that.

                   

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                    CarlWeathersForPres, Aug 25th, 2011 @ 10:33am

                    Re: Re: Re: Re: Re: Re: Re: Re:

                    No prob, I'll just start a corporation for Aspirin that has "insurance" and keeps little in terms of money in it's account. If you spend 2 years building up good will, who will realize that you're actually not doing your job until people start dying. When people sue, they'll essentially get whatever the insurance covered and whatever the plant is worth. As long as you do a good job keeping the books, there's no way to pierce the corporate veil and get at the big pocketbooks. Awesome solution.

                     

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                      Chris Rhodes (profile), Aug 25th, 2011 @ 12:02pm

                      Re: Re: Re: Re: Re: Re: Re: Re: Re:

                      Yeah, I often find that companies go out of their way to build up a huge customer base over long periods of time with quality products, and then dump vats of botulism into their product before grabbing everything out of the safe and running for cover. I suppose they'll tell themselves something like:

                      "Ha-HA! I was offering a product that everyone thought was great and I could have kept doing it year after year and raked in shitloads of money, but instead I grabbed whatever I could physically wheel-barrow out of my factory and went on the run! Sure showed them! Damn glad their wasn't an FDA to stop me!"

                      (Say, do you know where I can get a monocle and a tophat? Apparently, after my dastardly plan to eliminate the FDA comes to fruition, there will be some poor, uneducated people that I will want to crush under my evil, capitalist boots, just because I can!)

                       

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    Anonymous Coward, Aug 25th, 2011 @ 6:32am

    Oh humanity... Mixing in one bag big bad corporations, patents and evil witches. And still you have no clue of what's and why is going on.

    Let me tell you something: patents have nothing to do with a current drug shortage, as most of the stuff that's in short supply is off the patent. As such, anybody can make it. But. The big "But". To make the simplest easiest to synthesize drug, you have to go through the FDA scrutiny. And that is insanely time and money consuming. In a nutshell, to make a simple drug (hardware aside), you have to hire 5-10 chemical engineers, and a small army (hundred or so) of "compliance people", the only function of which will be to ensure that the facility is following the FDA regulations to letter. Guess what that will do to the price of the drug.
    You might ask - why does FDA has all this regulations? Simple answer - people want quality drugs. The only way to ensure the quality, is to create all these regulations. So, if something happens (hey, we are living in a real world, stuff happens) and lawyer-happy Americans will (for sure - there a whole firms out there for drug companies) start suing, FDA can say that they did everything humanly possible. And as long as manufacturing adhered to the FDA rules, they will use it as their defense.

    So, let me ask you, under these circumstances, whom should we blame? FDA? Nasty drug companies, who don't want to operate at risk and at loss? Cash hungry lawyers? Or a mass of American populus, who wants everything, at best quality, but without paying for that.

    So please, before you accuse anybody, do your homework!

    BTW, for those upset about the cost of new therapies, saying that they are based on government-sponsored public domain research, if you'll do the math, you'll see, that actual discovery cost is no more than 5% of the final tab. Even marketing (however controversial it is) is still cheap, when compared to the expense of complying to the FDA regulations.

     

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    Overcast (profile), Aug 25th, 2011 @ 6:43am

    But what about the children of executives that count on their massive profit?????? Who will think of them????

     

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    CarlWeathersForPres, Aug 25th, 2011 @ 7:19am

    How old are older medicines? It sounds like the drugs they're talking about are off patent and already in production, but companies don't want to make them because they're not profitable or the FDA has shut them down because the plants that are making them put other fun things(like bacterial contaminants which tend to kill people) into the drugs. In my opinion, this is the failure of the free market (subbing out to cheaper manufacturers and skimping on quality) and not as much a regulatory issue.

    Here are a few paragraphs that I found interesting that you seemed to gloss over:

    "More than half the recent shortages have resulted because government or company inspectors found problems like microbial contamination that can be lethal on injection. Others have occurred because of capacity problems at drug plants or lack of interest because of low profits, according to the F.D.A."

    “The race to the bottom has led to an increase of products coming from plants in China and India that may have uncertain supply and may have never been inspected,” Ms. Bresch said. “If the F.D.A. was required to inspect foreign drug plants at the same rate it does domestic ones, we might not have so many of these shortages.”

     

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    Jose_X, Aug 25th, 2011 @ 12:54pm

    gene patents can lock the public into outdated and costly health solutions

    IIRC (and fwiw), the NYTimes had something this morning (front page business section I think) on the genentech gene patents and how they use a procedure that is very costly and inefficient by modern standards (the patent expires soon). Also, they used to contribute their research to the public but stopped doing that recently to create a proprietary database.

     

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    Suzanne Lainson (profile), Aug 25th, 2011 @ 1:07pm

    Patents aren't the big problem with health care

    So we're talking about how patents slow down health care and make it more expensive.

    However, a lot of drugs are no longer patented and health care delivery is still too expensive. When our system can't afford to deliver even the basics of health care because it costs too much, eliminating patents isn't likely to change that.

     

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    staff, Aug 25th, 2011 @ 1:37pm

    bias

    Shortages in oil have happened yet there are no patents for oil. Rather, as the excerpt continues the shortage was "because it can be difficult and expensive to overcome the technical and regulatory hurdles".

    Once again you have proven yourself as biased and misleading.

    In Federalist No. 43, James Madison wrote regarding constitutional rights of inventors, "The utility of the clause will scarcely be questioned. The copyright of authors has been solemnly adjudged, in Great Britain, to be a right of common law. The right to useful inventions seems with equal reason to belong to the inventors. The public good fully coincides in both cases with the claims of the individuals."

    Figure it out already!

     

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    Anonymous Coward, Aug 25th, 2011 @ 7:48pm

    Unfortunately it costs millions in FDA fees to just press pills - getting the active ingredients is easy. The dosage form is the problem - look up the Perscription Drug User Fee Act. Want to make dosages? Pony up the cash. BTW small businesses get very few breaks in the USA - unlike the EU - where 90% of the fees are waived.

     

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    Willton, Aug 25th, 2011 @ 9:42pm

    For those of you who would do away with the FDA,

    I suggest you look at the circumstances of this country prior to the FDA being created and then explain why those circumstances are better than what we deal with now. Have you never read "The Jungle" by Upton Sinclair?

     

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    Anonymous Coward, Aug 27th, 2011 @ 11:41am

    This blog is really active. It should be renamed Masnick and the mindless multitudinous me-too morons. Masnick uses rational discussion but skimpy facts, half-truths and non-sequitors to rile up ridiculous ranters.It's interesting but unreliable.

    Patents are cited by mamy pharmaceutical firms as a key motivator in the funding of research leading to new drugs that save millions of lives.The hope of having the next blockbuster drug under patent is vital to justifying the huge investment top bring a key new drug to market. We know this because most new blockbuster drugs are originated in countries with strong patents-US, FR, DE JP, UK.

    The alternative is either no new drug R&D or Gov funded pharma R&D.

     

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    Suzanne Lainson (profile), Aug 27th, 2011 @ 11:56am

    The other side of the argument

    I believe the health care system in the US is broken. Or at least it is too expensive for what we get. However, I don't think the patent system and the FDA are the primary causes. I think it has more to do with how we consume and pay for health care.

    Here's a look at how an unregulated system can result in some questionable products. If we are going to explore the subject, we need to look at all issues.

    Drugs Posing as Supplementals May Contain Dangerous Ingredients - NYTimes.com

     

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    Mary Francis, Mar 29th, 2012 @ 1:38am

    writer royalties unpaid and given the runaround big time

    I have been a writer for over 30 years in Nashville. I have several cuts by major artists and independent artists. I have had 2 major hits -- Whiskey If You Were a Woman and Tonight the Heartaches on Me. When I called EMI last week, I left a message asking when I would get my royalty check. A man in the royalty dept called me back yesterday (3/27/12) and told me the checks would go out April 1, but he said my address was invalid. I told him, I ha been at the same address for 25 years. Then he asked me if I had received an October payment in October of 2011, I told him I was unsure, but I asked, "Why don't you have that info since I received a 1099 for 2011?" He made up some kind of rigamerole about the financial dept and royalty dept not being connected to one another - Lies, lies. I then asked him to tell me how I would get if I had not received my Oct 2011 pay, he said he would have to tell me that when I called back. I called back today and told him I did not get paid in Oct. 2011 and my 1099 also reflected that. So, I asked him when I would get paid; then he said, he couldn't tell me and that a lady in their office would be researching it but he did not have any idea how long that would take. I do not plan to let this go by. I will fight, and if I have to take legal action. I have not been paid in over a year now. This appears to me to be a clear-cut attempt to defraud. I work for attorneys so I don't think I'll have a problem finding representation.

     

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