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United States Science

Crisis in Science Prompts Sharing of Data 184

Posted by Zonk from the varieties-of-mice-that-nature-forgot-to-make dept.
Carl Bialik from the WSJ writes "'The crisis in "translational science," or turning basic discoveries into therapies, has been brewing for years, but it hit a depressing nadir in 2005, when just 20 new drugs won approval from the Food and Drug Administration,' Sharon Begley writes in the Wall Street Journal. Concerned researchers and foundations are pushing for more sharing of data between basic scientists and clinical investigators, and Stanford is launching a program to train doctoral students in bench-to-bedside research."
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Crisis in Science Prompts Sharing of Data More

Crisis in Science Prompts Sharing of Data

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  • Can't be true! (Score:2, Funny)

    by Anonymous Coward
    2,000,000 patents were discovered in science last year!
    • It's so sad that patents can't have the same standards of rigor
    • 2,000,000 patents were discovered in science last year!

      Patents are not discoved! They are a God Given Intellectual Property Right, enshrined in the constitution and one of the fundamental Rights of Man*.

      **The fact that corporations are not technically men has no bearing on their applicabilty to corporations. Dissenters will be dealth with.
    • I would say that is the main problem. I believe competition is nice to fire up people to do their best, but there are limits in the "collaboration vs competition" fight.

      The scientists working for medical corporations hide valuable information from each other in order to keep their strategic advantage, or they disclose it but make it unavailable through patents to those who could benefit from it to their own projects. Then, scientists have to invent the wheel all the time, making it a lot harder to evolve.

      Al

    • Re:Can't be true! (Score:3, Insightful)

      by Heembo ( 916647 )
      when just 20 new drugs won approval from the Food and Drug Administration

      Crisis? Seems like they are getting their act together. It takes TIME to really know what these drugs do, and I for one am not happy with so many drugs get released and are then pulled a few years later due to some life threatening side effect.

  • I'm not sure I understand... (Score:4, Insightful)

    by minginqunt ( 225413 ) on Friday January 20, 2006 @11:51AM (#14519175) Homepage Journal
    So, what, the 'success' of science is now judged by how many drugs are rushed through FDA certification without proper testing?

    Or is there a real crisis here that the article doesn't do anything to elucidate?

    • Re:I'm not sure I understand... (Score:5, Informative)

      by BarryNorton ( 778694 ) on Friday January 20, 2006 @12:00PM (#14519252)
      So, what, the 'success' of science is now judged by how many drugs are rushed through FDA certification without proper testing?
      Erm, no - 'proper testing' is centred around Phase I&II Clinical Trials, and they want more of these, not fewer...
      • Those phases are still largely a waste of time as long as you don't actually have to test your brand new drug against anything other than a placebo.

        For all we know, the brand new, cutting edge, hot from the lab pain reliever may be less effective than whatevers already on the market.

        I don't care how many of these tests they want to do. A whole load of crap is still crap.

        -stormin
        • Those phases are still largely a waste of time as long as you don't actually have to test your brand new drug against anything other than a placebo
          Say what you like about testing efficacy, but testing safety is a very important part of clinical trials...
          • Testing should start there.

            Right now FDA testing lets you know (w/ varying degrees of certainty)
            1. That the drug doesn't hurt people
            2. That the drug helps people more than a placebo

            Say all you want about improving the certainty of either of those, but I think we ought to include testing the drug against existing treatments not as an afterthought, but as a fundamental evaluative criteria.

            -stormin

    • Re:I'm not sure I understand... (Score:5, Interesting)

      by IWannaBeAnAC ( 653701 ) on Friday January 20, 2006 @12:08PM (#14519313)
      Yes, there is a real crisis, and no the article doesn't get to the bottom of it.

      The fields of science affected by patents are worst affected, but all fields of science are today in at least some form of crisis. "Publish or perish", and a bureacratic/accountancy driven push for quantity of publications over quality, has caused an explosion in the number of published articles and an equally dramatic drop in the substance of said articles.

      The result is that even in a small sub-field, there are too many publications for an indiviual to keep track of. Actually reading other people's articles takes a lot of time, often only to discover that the reported research is superficial and the time spent understanding the paper was wasted anyway. This results in people not bothering to read the literature, and instead just repeating work some other group has already published. This contributes to the explosion of publications, and thereby keeps the bureacrats happy. But the effect on science is overwhelmingly negative.

      An associated effect is that the real interest in the research is often obsfucated in the publication. If it was clear from a cursory reading how superficial the research was, the journal referee's might reject it. And if some other research group can figure out exactly what you did, they might be able to reproduce your work and scoop your future researches.

      Fields subject to commercial interests suffer extremely badly from this, to the extent that in drug research, much of the interesting research is never published publically at all.

      /physics postdoc

      • This is a tough egg to crack because everything revolves around money. Research requires money, and unless there is measured output, money invested is considered lost by the enterprises that supply said money.

        Add on to that that much of the research money comes from private or public for-profit agencies, and you have a real connundrum on your hands.

        Unfortunately, pure science and pure investors often clash when it comes to desired outcome. Scientists are often happy to take years and years to develop therapies or make discoveries to be sure that the science itself is rock-solid. However, investors require that their investments - often not all their own money - yields dividends and results in made money.

        Until we have some system in place that supports scientific research without requiring an immediate return on ivestment, this crisis will continue unabated.
      • ... an explosion in the number of published articles and an equally dramatic drop in the substance of said articles. The result is that even in a small sub-field, there are too many publications for an individual to keep track of. Actually reading other people's articles takes a lot of time, often only to discover that the reported research is superficial and the time spent understanding the paper was wasted anyway.

        You can never have too much information. A search engine could fix your problem if all the

      • Well, the real problem is that there is no money. The beginning of
        the twentieth century saw a great expansion of funding for science,
        thus great projects, great advancement and little competition
        (as compared to today at least). Part of the reason competition was
        not as vicious was that the number of people in science did not
        catch up to the available funding. That changed in the seventies and
        pain began. It got real bad in the beginning of the nineties in
        physics when Congress cancelled the superconducting super

    • Re:I'm not sure I understand... (Score:5, Informative)

      by Isca ( 550291 ) on Friday January 20, 2006 @12:09PM (#14519321)
      No, the real problem that the article is trying to point out is that thousands of new medical discoveries are made every year. However, just a fraction of those are deemed to be worth the money to spend massive dollars getting from the point of being a Lab breakthrough to being a developed drug or technique. Getting a drug approved, even in todays "rushed FDA certification" you speak of still takes millions of dollars and years of time. Most of the truely revolutionary drugs are marketted and sold overseas long before being available here for this very reason.

      I'm sure the patent flurry isn't helping much either, since the delay in publishing something to make sure that companies (and in today's world, university foundations) can set things up so that they can maximize profits of any derivitives of their work. This process takes much more time than it used to.

      I think the interesting part of this is the fact that groups that are actively sponsoring specific diseases are starting to fund these studies from start to finish. I'd love to see more of this. there are hundreds of illnesses and diseases that do not have a large enough number of people who are stricken to justify the cost of developing a drug worth it. by allowing researchers to share data quicker, and better, foundations that are supporting research may just have the power to do everything short of manufacturing the drug. They can't afford to pay for broad testing, however, so they need to rely on more access to other's research so that they can focus on the most promising paths of their own.

      • Most of the truely revolutionary drugs are marketted and sold overseas long before being available here for this very reason.

        Yeah, like Thalidomide [wikipedia.org]. Approved overseas, where it caused thousands of babies to be born with very severe birth defects. Not approved in the US, because of the slow FDA process.

        Be careful what you wish for.

        Sean

  • Why would the business people want that? (Score:5, Insightful)

    by Colin Smith ( 2679 ) on Friday January 20, 2006 @11:52AM (#14519184)
    By restricting the sharing of information and data, the maximum profit potential can be extracted from it.

    • Re:Why would the business people want that? (Score:5, Insightful)

      by recycledpork ( 808313 ) on Friday January 20, 2006 @11:59AM (#14519241) Homepage Journal
      Actually I think that pretty much every economic theory would suggest that trading and sharing actually benefits all parties involved. I realize that you are being sarcastic, but maybe if people would actually apply the knowledge humans have acquired instead of just doing business as usual we would all be better off.

      • Re:Why would the business people want that? (Score:5, Insightful)

        by TubeSteak ( 669689 ) on Friday January 20, 2006 @12:05PM (#14519297) Journal
        Pharma companies consider failed clinical trials to be trade secrets.

        The FDA is not legally allowed to divulge the results of anythign that's withdrawn from approval.

        Basically, if everyone told everyone else about what didn't work, the only companies that would benefit are those developing similar products. First to market usually has a huuuge advantage, which is why no company wants to help its competitors get ahead.

        This addresses only one aspect of TFA & what you're saying, but that's how it is. Not that it is a good thing, since undisclosed trials/failures usually equates with undisclosed risks.
      • Actually I think that pretty much every economic theory would suggest that trading and sharing actually benefits all parties involved.

        But you are adding a presupposition in your hypothesis. "benefits all parties involved" implies a limited subset of economic theories; those that are intended to benefit societies, such as capitalism, communism, and socialism. This neglects the one we use in the United States; corporatism. Corporatism is essentially tribalism applied to the corporation. Each tribe sees itself
        • Please be more careful in your use of pronouns. I couldn't tell you the name of that show either, because I have never seen it, because when I heard about it I dismissed it as uninteresting and totally disconnected from my life. Thus your use of "our" is a bit strong.
          • "Our" meaning the US's, which does not include all Slashdot readers (but does include me). Much as when I say, "Our national religion is Christianity", it is the de facto truth - the nation is implied to be the nation of which I am a citizen. I don't like all the cultural identities that are ours, and in particular the religion and tribalism bug the shit out of me, but that doesn't mean they are not true. We (the citizens of the US) are all in this together as far as national identity goes. Rather than divi

      • I agree sharing does benifit us all. Unfortunately, drug companies seemed to be focused on maximizing the share price for the investors. In that light, does it make sense for a drug company to own part of a drug or all of a drug? Sharing profits on a drug will affect the company's bottom line. I think share holders and stock analysis would look less favorable on those companies. It's not about how better science can drive the drug industry, it's about how money drives the drug industry.

        • Ask the question another way. Does it make more sense for a drug company to have 100% of $1billion, 50% of $3billion, or 33% of $10billion? If sharing would do *that* much good then sharing would indeed maximize shareholders' return.
          • If 100% of $1 billion meant that they had a monopoly, many companies would go for the monopoly.

            Ever consider just what a "patent" is? It's the grant of a monopoly. Originally the king delegated to one of his friends the monopoly of the taxes extracted from some area. This was called a patent of nobility. Our current patent system descends from that idea. (And isn't it a GREAT idea...as long as YOU are the friend of the king.)

            • I learned what a patent is decades ago. Apparently what's needed is not instruction on patents but instruction on arithmetic. 33% of $10billion is more than THREE TIMES AS MUCH MONEY as 100% of $1billion. Any board that would leave $2,333,333,333.33 of their shareholders' money on the table to finance members' private power trips should be turned out, and perhaps sued. They have wantonly wasted company resources and caused their shareholders' business to underperform.

      • maybe if people would actually apply the knowledge humans have acquired instead of just doing business as usual we would all be better off.

        What are you, some kind of communist?
    • I think this is where an overhaul to the patent system could come in handy. The original patent system was supposed to encourage the sharing of information. However it has been twisted and twisted until it discourages the sharing of information.

    • But we all know it's impossible that sharing data could be used for good, anyways. Why even bother trying to profit?

  • FDA regulation by design (Score:4, Insightful)

    by Anonymous Coward on Friday January 20, 2006 @11:56AM (#14519208)
    Creates barriers to entry.
    Consolidates power into large multi-nationals.
    Preserves the status quo.
    Does not change the fundamental fact the individual must remain responsible.

    The FDA cannot make you safe.

    We would probably be just as unsafe as we are now, but with more choices, faster time to market, and with smaller companies participating.

    If we had had an FDA for computers we would never have had a PC revolution start in some stoner's garage.
    • But without the FDA, what exactly would be the difference between drug companies and your local ketamine peddler down the street?
      • "But without the FDA, what exactly would be the difference between drug companies and your local ketamine peddler down the street?"

        Well...for starters the K dealer down the street probably has lower prices, not to mention he'd probably be more forward about what the drug did to you than Big Pharma would.

        I, for one, welcome our new Ketamine Dealer Overlords...

    • Re:FDA regulation by design (Score:5, Insightful)

      by Waffle Iron ( 339739 ) on Friday January 20, 2006 @12:22PM (#14519426)
      Your approach to drug deregulation was tried in the 19th century, and it was an abysmal failure. Most drugs on the market were ineffective, dangerous, or even lethal.

      Today, this unregulated approach continues with the "herbal remedy" market. Once again, most of these products are ineffective or dangerous.

      Where do you get the idea that things would be any different if no approval were needed for real drugs today?

  • Wonderful (Score:2, Insightful)

    by LostAngel ( 891826 )
    Oh yes, I would much rather have 5000 new drugs, that might have adverse side effects and will kill me...than to have 10 new drugs that have had a bunch of research done...
    • Your logic makes sense, but that is not what happens. Look at how many drugs were pulled from the shelf or were said to have risks. Hell look at one company.. pfizer last year. Most of their key drugs were found to be bad for one reason or another. Those drugs mostly came from a company they bought. In theory, a LOT of tests should have been done on those drugs. It obviously didn't help or didn't happen.

      The other problem is there are a lot of things we could cure today if we didn't have to deal with l

  • When you make science commercial... (Score:5, Insightful)

    by analog_line ( 465182 ) on Friday January 20, 2006 @11:58AM (#14519231)
    Science is run by corporations now. Non-commercial scientific research has been getting the gas pipe for years. Corporate scientists are more than willing to take all the data the silly hippy scientists are willing to give them for free. They're not so willing to share their data in return, because their shareholders will string them up.

    This is what you get with that cushy research job at the biotech company, folks. Now it can start biting you in the ass, just like your greed has bankrupted the rest of us.
    • Science is run by corporations now.

      I disagree. Still, most science is funded by the government and run by universities and government labs. Corporations typically only spend at most 10-20% of their budget on RND, which includes science.

      The exception is bioengineering, bioinformatics, and similar. Mostly because they are trendy and they can get startup money just like the pre-dotbomb era of the internet.

      I currently work with oceanographers, physicists, chemists, and bioinformatics people. The only privat
    • So you're saying that scientific research needs a GPL-like tool?

  • Been there/Done that (Score:5, Interesting)

    by Kainaw ( 676073 ) on Friday January 20, 2006 @11:58AM (#14519237) Homepage Journal
    I've been working on clinical research for a long time now. The issue isn't quantity, it is quality. I can quickly produce a database of a couple million patients for you, but it would be crap data. When I verify the data, I get far less (around 300k). But, I've just hit a problem that I see in clinical research. If, for example, I refuse to consider a person with a blood pressure below 70/30, I have just skewed the results. On the other hand, if I accept typos from the millions of medical clerks who, in my opinion, are not required to understand basic spelling or typing techniques, I skew the data. There is no way to get truly valid results. I just get estimates and comment on trends. I let the doctors make assumptions about the trends. It could be that a new employee is typing in the weights and she keeps hitting '2' instead of '1' - then suddenly the patients started weighing more. A doctor will attribute the weight gain to McDonalds. I'm sorry, but there's no real point here. I just wanted to explain a bit of what is really going on in these clinical research areas.

    • Re:Been there/Done that (Score:3, Interesting)

      by xoip ( 920266 )
      It could be that a new employee is typing in the weights and she keeps hitting '2' instead of '1' - then suddenly the patients started weighing more.
      What about Docs who enroll marginally qualified patients into a study to collect the cash from the drug companies?
      • "What about Docs who enroll marginally qualified patients into a study to collect the cash from the drug companies?"

        Or...how about the moral flip-side...doctors who enroll marginally qualified patients into a study because they feel the experimental drug is the person's best chance for a cure/survival/a better quality of life? Remember, there's two sides to every coin.

        • Or...how about the moral flip-side...doctors who enroll marginally qualified patients into a study because they feel the experimental drug is the person's best chance for a cure/survival/a better quality of life?
          What if it's a double blind study and the patient gets the placebo?
    • Seems that some sort of automated data collecting machine would be useful here. Index the data based on some sort of biometric information sufficiently elaborate that you get few collisions.

  • Hmmmm. (Score:4, Insightful)

    by SatanicPuppy ( 611928 ) <Satanicpuppy.gmail@com> on Friday January 20, 2006 @12:00PM (#14519245) Journal
    It's almost like crazy patents are stifling innovation...Who'da thunk it?

    Seriously, as long as you have to pay, and pay, and pay just for the methods to work with x or y type of gene so that you can SEE what your drugs are doing, you're not going to be zipping along at record pace. And, as ridiculous as IP law has become, I can't imagine you'd be comfortable bouncing ideas off your peers at other labs...I mean, the point of that is to see if they have a solution, but if they have a solution, then they'll probably throw a cup of hot coffee in your face and run down to the patent office.

    What did they think was going to happen when they started this crap?

    • Re:Hmmmm. (Score:3, Informative)

      by TubeSteak ( 669689 )
      Did you even read the article summary, much less TFA?

      Patents aren't mentioned once.

      The problem TFA is talking about has nothing to do with patents and everything to do with research not being converted into useful therapies/products.

      Maybe patents are the underlying cause of this, but you don't back up your claim with any facts. And no, the point isn't to see if you have a "solution." A solution to what? This is about basic research.
      • Probably because the article is crap. Seriously. I'm a Ph.D. who does research in basic biology for a living. The article's author proposes we don't think about converting our discoveries into applications to treat human disease. That's rubbish. Every basic research I know would absolutely love having his discoveries result in a cure for some disease. We think about it all the time. The thing is, most discoveries aren't directly translatable into a treatment.
      • He may not mention patents, but he does talk about increasing the communication all along the pathway from research to end product.

        Communication has to be two-way to be effective. So does motivation. If I find something of interest, I'm generally glad to share. If you take my pearls of wisdom, and don't say anything useful back, other than, perhaps, "Thanks, sucker", then I'm less inclined to say things that will help YOU next time. One response to this was the GPL. (BSD came first, but many people got
    • They thought that actual innovation happens only because of money. Seems a perfect money junkie thinking to me.

      See, they see all world as property of something, someone. Anyone belongs to someone, there should be no free tools, free goods, and specially, no free knowledge. Someone should do money out of it.

      Why they think so? Hmmm...what about some ill-based theory that greed is something "healthy"? Don't matter that couple of psyhologists would insist on something in lines about "luck of love" or "felt cold
    • It's almost like crazy patents are stifling innovation...Who'da thunk it??

      How many drugs do you think would have been made if there were no patents given the extreme cost to get a drug approved. The high cost of regulation is what is stifling innovation, not patents.

  • only 20 new drugs? (Score:4, Insightful)

    by Analog Squirrel ( 547794 ) on Friday January 20, 2006 @12:00PM (#14519250) Homepage
    Oh my god!!! Seriously, are all the old ones becoming obsolete or something? Isn't that where the pharmaceutical companies should be making most of their money? Or is there such a premium on "new" drugs that they can't stay profitable without them? If that is the case, it sounds to me like there are some pretty unsustainable business models out there. You really can't dictate innovation... unless of course, someone starts designing new diseases so you can then trot out the cure to them as a new product...

    • Seriously, are all the old ones becoming obsolete or something?

      As far as the developing Pharmas are concerned - they're all going off-patent without being replaced.

      Or is there such a premium on "new" drugs that they can't stay profitable without them?

      Bingo!

      If that is the case, it sounds to me like there are some pretty unsustainable business models out there.

      You say that, but these are some of the most profitable companies out there, and have been for decades.

      • But decades isn't really all that long in a sustainable business sense. Clothes would be sustainable, because everyone wears clothes, and clothes wear out, thereby creating the need for new clothes. Creating new drugs is not sustainable because you start off with a lot of diseases to cure, and eventually, you cure them all (hopefully). Unless new diseases are coming out at a rate that you can sustain your business, then making new drugs is not sustainable. In the same way, cutting trees isn't sustainabl
        • But decades isn't really all that long in a sustainable business sense. Clothes would be sustainable
          Hmmmm, try telling that those living among the empty mill buildings in Yorkshire, where I come from. I believe the United States' own clothing industry is largely sustainable only due to trade sanctions they impose against the Far East...
          • I wasn't referring to any specific clothing company, but rather clothing as a whole. People will always need clothes, and therefore, there will always be a clothing industry, regardless of where it's located. On the other hand, drug companies had it easy before they cured most of the diseases. As more diseases get cured, there is less business for them, and the industry as a whole suffers. Once there are no more diseases to cure, there is nothing on which to have an industry, except in production, which
            • As more diseases get cured, there is less business for them, and the industry as a whole suffers
              The Pharma industry has this covered - every important 'cure' introduces side-effects that need new drugs as companion treatments... ad infinitum.

        • Re:only 20 new drugs? (Score:3, Insightful)

          by mwood ( 25379 )
          "...unless you create new diseases." You've been reading "The Sumerian Oath", haven't you.

          Anyway, drugs don't cure diseases; they cure *instances* of diseases. If a doctor sets your broken leg, that doesn't mean there won't be any more broken legs in the future. Likewise my taking something for high cholesterol doesn't prevent someone else developing high cholesterol today or 100 years from today. Most drugs being developed today are not aimed at killing pathogens, but at adjusting the patient's own che
          • The problem is, is that once your patent expires, anybody can make your drug and sell it. If you are in the business of making new drugs, then you have to come up with a new drug, to replace the drug that everyone else is also making. If you are in the business of producing already known drugs and selling them, this is competely sustainable. If you are in the business of coming up with new drugs and selling those, there will come a point when there is no more need for businesses coming up with new drugs
            • I still don't see where the need for new drugs tapers off. The current crop have some rather scary side-effects -- there's lots of room for improvement. There's room to tackle health issues which don't get much attention because there are more urgent ones to deal with, or which people have hiitherto believed intractable. There's a lot about health we still don't understand *at all*. Maybe in a thousand years, or five thousand, we'll hit that knee. In the shorter term I'm reminded of the head of the pat
        • But decades isn't really all that long in a sustainable business sense.

          I disagree on two points. First, sustainable isn't important, profitable is. Second, decades are a long time in a business sense whether it be sustainable or not.

    • Or is there such a premium on "new" drugs that they can't stay profitable without them?

      There is ABSOLUTELY a premium on new drugs! One reason is that a minor tweak to an existing drug creates a whole new drug. This can be patented and sold for a premium price. If the drug is only slightly better than an older one, doctors will almost always prescribe the new one.

      Also, and more importantly, when old drugs lose their patents, everyone (at least those who are sane) will buy the generic drug. What if Lilly s

    • If that is the case, it sounds to me like there are some pretty unsustainable business models out there.

      Not at all. Some companies are research companies, they spend the money on R&D and make it back from having new drugs. Once they've become commoditized, that particular drug becomes the provenance of other manufacturers who don't bother with the R&D. The research company needs to be discovering new stuff, but that's their job, it's what the money goes on.

    • obsolete drugs (Score:3, Informative)

      by raygundan ( 16760 )
      Oh my god!!! Seriously, are all the old ones becoming obsolete or something?

      As a matter of fact... some are. We're gradually losing the antibiotics arms-race with the germs as resistant strains to the best we come up with keep popping up. We only have a few drugs left that still kill the worst multi-drug-resistant strains.

      In these cases, we do indeed need new drugs because the old ones are obsolete.

      Your point about the business model is valid, though. Outside of the drug resistance issue, in many cases,
      • Patent control certainly isn't the only issue. Alot of the newer drugs coming out on the market are alot more specifically targetted, and subsequently have less side effects. Developing drugs that bind to only a specific subtype of receptor rather than the entire class of receptors, for instance, allows the condition to be treated with fewer side effects: just because the efficacy itself isn't improved doesn't mean that a newer drug can't be an improvement.
        Let's look at a class of drugs in the news lately.
    • Oh my god!!! Seriously, are all the old ones becoming obsolete or something?

      Well considering the fact no matter how many current drugs we take, that we still die of natural causes... I'd still say they have a bit of work to do.
    • "Or is there such a premium on "new" drugs that they can't stay profitable without them? If that is the case, it sounds to me like there are some pretty unsustainable business models out there. "

      Actually...I believe (though I don't have sources to cite) the answer is yes. Drug companies have become quite 'addicted' (pun intended) to the blockbuster-drug phenomenon. Having a new blockbuster is literally like winning a multi-BILLION dollar jackpot that then immediately.......

      "You really can't dictate inno

  • It's not the scientists, drug companies, or lack of collaboration that's the problem - it's the FDA. They are far too restrictive about what is approved, and approval takes much longer than it should. An expedient and more reasonable policy of approving drugs (if approval should be necessary at all) would save a LOT of lives.

    • Re:The problem is the FDA (Score:2, Insightful)

      by Anonymous Coward
      Rushing it not a good idea. Proper testing is necessary. What you are proposing could cost a greater number of lives.
    • An expedient and more reasonable policy of approving drugs (if approval should be necessary at all) would save a LOT of lives.

      How? How, would reducing safety checks on drugs make them safer? How would decreasing stringency on drug side effects benefit people? This seems counterintuative in the extreme.

      Could you please cite a scientific study or something, because it just sounds like male bovine faecal matter to me.
    • There's only one case where I agree with you, and that's when a drug has been tested extensively internationally and there's solid clinical data there to back it up. If a drug's been used in Europe, Asia, or Australia for years with no major incidences of serious side effects, then YES, it should be fast-tracked for approval. If the data's there internationally to show the drug's safe, why should the US researchers need to replicate years and years of European data and navigate that red tape?

  • Kind of calls into question patent laws. (Score:5, Interesting)

    by micheas ( 231635 ) on Friday January 20, 2006 @12:06PM (#14519301) Homepage Journal
    Congress shall have power . . . To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.


    If we are having a lack of new drugs and everything is being patented, are patents still constitutional?

    • Quoth the poster:
      If we are having a lack of new drugs and everything is being patented, are patents still constitutional?

      It's worse than that. Not only do the patents stifle innovation, but the lumbering bureaucratic behemoth that is the FDA makes it incredibly expensive to bring any drug to market.

      What the fuck happened to freedom of choice?

      It's my body, I am the only one who can properly make the decision about what medication is "safe enough" for my circumstances. Wake up kids, the FDA is not prot

    • The crisis the article describes is one of information sharing. A handful of institutions sharing data with themselves is not going to overcome the larger problems of publication and that is a copyright issue. Industry publications are covered with ND nonsense and it's harder than ever to find them, even in university libraries.

  • Slow because... (Score:5, Interesting)

    by SnarfQuest ( 469614 ) on Friday January 20, 2006 @12:06PM (#14519305)
    It could be that research has cooled because of the large number of lawsuits being thrown at them. Why spend all the money developing a new drug, when any possible profits will be eaten up by numerous lawsuits, and the resulting high price will be used as justification for allowing a company in a third world nation to steal the design and sell a cheap copy.
    • Why spend all the money developing a new drug, when any possible profits will be eaten up by numerous lawsuits,...

      I, for one, will cry myself to sleep tonight thinking about all those pharmaceutical company executives who are consigned to lives of dire poverty by their pitifully small $10 million/year compensation packages. Thank goodness they continue to manage their pharmaeuctical companies out of the goodness of their hearts because they certainly don't do it for the money.

    • Hey, lawyers need to feed their children too!

  • Making mice is translational? (Score:3, Insightful)

    by nucal ( 561664 ) on Friday January 20, 2006 @12:07PM (#14519307)
    "The collaboration has gotten 'pure' researchers out of their ivory towers and truly engaged in working on human disease."

    Making a knockout mouse may be a more physiological model but it's still a far cry from really working on human disease. It may be more sophisticated than cells in a dish but it's still basic research.

    What does this author have against basic research anyways .. the tone of the article is really negative:

    It has a pile of discoveries to show for it -- but no cure.

    Discoveries, after all, are supposed to be good for something besides filling science journals.

    No kidding! But how can anyone even begin to take a rational approach to medicine without basic research? There is a place for excellent basic research, just as there is a place for truly clinically oriented research.

    • Making a knockout mouse may be a more physiological model

      I love that phrase: knockout mouse. Makes me think of some Bugs Bunny-style mouse wearing a tight sweater & lipstick.

  • Patents and IP are a problem (Score:5, Insightful)

    by MojoRilla ( 591502 ) on Friday January 20, 2006 @12:14PM (#14519351)
    If we wonder why there are less and less drugs getting approval, we need to look at what researchers and universities are doing with the science the American taxpayer pays for.

    Since 1980, universities and individual researchers have had the right to patent IP paid for by public funds [wipo.int]. This was obstensibly done to "facilitate the exploitation of government-funded research results by transferring ownership from the government to universities and other contractors who could then license the IP to firms."

    However, it is clear how this would have a chilling effect on basic research. Surely cooperation has suffered at the expense of competition. Patents have been a disaster for software, where synthesis of many ideas are important to create products. It is probably similar for the biological sciences.

    These researchers are funded by public money. Their results need to be used for the public benefit, and shared publicly.
    • While it may seem counterintuitive, patents have actually increased translation of basic research to pharmaceutical drug development. The reason is quite simple--taking a drug from basic discovery to FDA approval is enormously expensive--generally far more costly than the initial discovery of a patentable compound. Pharmaceutical companies are reluctant to make such a huge investment if they do not have an exclusive license, because other companies that do not have to recoup research costs could simply make
  • Read between the lines.

    The US government plans continued cuts in basic research funding.
  • Maybe Wikipedia [wikipedia.org] can help with this crisis in information sharing?

    Helping out humanity is one more reason to share data. Kindness with compassion is another.
  • While it is certainly true that there's a lack of feedback between clinic and lab, there are reasons.

    First off, confidentiality regulations make the exchange of useful data a complex task. It requires careful planning, auditing for compliance, and some very special arrangements on how it's handled. Compliance makes it not for the faint of heart (or faint of wallet).

    But the article misses the greater point: namely that basic and fundamental research on the etiology of disease is difficult and expensive (espe

  • It's a total disaster out here in Med Land (Score:5, Informative)

    by GNT ( 319794 ) on Friday January 20, 2006 @01:04PM (#14519794)

    First, let me say I am a primary stakeholder. I am a Chief Medical Officer in a medical device company with a device that shows spectacular clinical activity.

    Well, the patent holders in the arena have damnable method patents on all the key parts, and haven't done squat in the arena for better part of 20 years. And it's an almost impossible logjam of non-collaboration. So once again, irrational patents rear their ugly head. And we won't talk about patents on naturally occuring proteins, not a new man-made drug, but a protein made from recombinant methods of naturally occuring DNA. I urge everyone to take a look at the patent on BMP-7 -- 1996 -- almost certain to reverse major tubulointerstitial damage in the kidneys, languishing on the vine as a result of the patent. (Hey, OrthoBiotech -- how many more years before you pull the trigger?) While the inventor deserves a Nobel for the clinical identification, he does not deserve a patent. He didn't invent BMP-7. Nature did. He noticed what it does and proved it beyond clinical doubt.

    While the device-side of the FDA is a reasonable 2-3 years for approval at low cost (though still mostly useless and an extra-step) the drug-side is totally criminal in its existence. We are approaching 1.2 billion dollars to get a drug thru the process and it is absurd. Every time the FDA expands its regulatory web, fewer drugs and devices make it to market. It's a huge resistor sitting across the current of medical creation.

    I don't need either patents or anything else to protect my market. It's hard enough to make science into clinical treatment that anyone who can do it and compete with me is welcome. What I need is the damn artificial stakeholders to be de-empowered by the elimination of method patents, elimination of patents on naturally-occuring proteins, elimination of obvious patents on combined therapy.

    I also need the huge regulatory web that dictates patient selection and over-restricts my patient base to go away. One would think that multifactorial statistical analysis was a forgotten or unknown art listening to FDA regulators. And the damnable meaningless questions, the endless drivel the FDA requires to prove safety. There is no such thing as safety -- negatives can't be proved. I can only prove harm. My device has a 3% mild complication rate and what looks like an 80% remission rate against diseases that are uniformly fatal. Why the hell do I have to jump thru a zillion hoops to get to a damn feasibility trial with people dying like flies? In a country based on freedom, we have no health freedom.

    And there is no such animal as an FDA scientist. Even those with Ph.D.'s in the sciences are bureaucrats. They are interested that their precious questions on their forms are answered not that the device/drug works or simplifying things to get something to market. Well, the cost of those forms are tens of millions of dollars of work, most of which is NOT essential to making the damn thing happen clinically. And the hubris -- we at the FDA guarantee safety -- what bs -- how many have died from Vioxx -- how many have died waitng for beta-blockers to show up -- how many drugs with good but not great clinical activity never made it due to regulatory cost?

    And the socialism of medicine -- with CMS/HCFA dictating reimbursement, fer cryin out loud, why should anyone go into business when they can't get a real market price on anything. There are great devices just sitting in the wings which don't come into the market because overall reimbursement is peanuts relative to value. Noone is going to deliver to market a device with a treatment price of $15K, a direct cost of $5K that has only a 500 dollar reimbursement level. Oh, without breaking the non-disclosure agreement, let me say it would be worth your 15K to have the treatment even if it was out-of-pocket. In mass-market mode the cost of that device would plummet to peanuts over 5 years.

    Obviously I am very frustrated that I can't deliver, for mostly artificial reasons

  • Patents are a big problem. (Score:5, Interesting)

    by ZombieRoboNinja ( 905329 ) on Friday January 20, 2006 @01:25PM (#14520009)
    My dad's an immunologist working for a private firm developing cancer drugs. I asked him about the whole patent issue, and he said, "When we come out with a new product, we WILL get sued." That's just how the industry is now.

    What's worse, he says, is that even straightforward research involves a lot of legal hurdles. You can't just do your research, produce your chemicals, etc. in the most straightforward way, because it might get you sued for patent infringement down the road. Everything takes longer because of these legal hurdles. And nobody working in private industry publishes in scientific journals, because they'd lose out on patents and screw over their company.

    Of course, my dad has his name on a bunch of patents himself. I'm sure his company is just as anal about protecting their own patents as everyone else. So really, the only people who get a net benefit from the current situation are... the patent lawyers.
  • ... but it hit a depressing nadir in 2005,

    Hey I know he was a spoiler and a can be a downer, but violence solves nothing man.

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