Beyond the public debt: making a wider case for openness

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24 Responses to “Beyond the public debt: making a wider case for openness”

  1. gsilas says:

    Cory, while I agree with your proposal, it seems that the pharma industry model is nearly unsustainable if driven following public interest.  People demonize pharma companies for operating in their financial interest, while research productivity appears to be decreasing and the industry is apparently not doing well.

    As someone who is targeting a career in biomedical scientific research, I follow the state of the pharmaceutical industry very closely.  I find it interesting that hiring at the position of scientist among pharma to be at its lowest level in history (see blogs “In the Pipeline” and “Chemjobber” to name a few), with companies consistently purging R+D employees over the last four years.  At the same time, critics of the pharma industry will use phrases like “in the face of record profits”, and decry the firing of scientists as a failing business model.  When myself and the underemployeed scientists that I work with have difficulty (near impossibility) in being hired into the pharma world and starting careers as a scientist, the sector is clearly not healthy.  The best scientists I know now have been unemployed for over a year, hired to a temporary 6 month position, or working as postdocs on unsustainably low pay.
    Hypothetically, if the industry were found to be unsustainable in the face of an even more harsh economic environment, it would be unsurprising to see more opiods developed and less chemotherapeutics, certainly no drugs against neurological disorders (Parkinson’s and Alzheimers have been historically expensive research areas without payoff).  How would people feel about this?

    If companies are operated solely on the public good, yet are financially unsustainable, how do we negotiate this fine line?  Clearly, as is, things need to change.

    •  The fact that pharma companies are not conducting much research these days doesn’t mean they were unsustainable, just that they found they could make more (and more reliable) profits by cutting spending in the research department.
      And granted, it’d be easier to make profits on stuff if you don’t have to prove it actually works and doesn’t harm people, but that should not be a reason to reduce obligations to publish data.
      Also, I don’t think that forcing OA on pharma companies would impair them commercially in any big way. The publishing fees are small compared to the costs of the research itself, and it might even improve their standing with the public. Also, it wouldn’t force companies to give away company secrets, beacuse OA would only be imposed on publications that would otherwise be published in other Journals where at least the competition will be able to read them anyway, so there’s no additional information leaving the house, it would just be reaching more people. And you should be happy about that because it makes a scientist’s live that much easier if a paper is just accessible without fuss.

      One problem I could foresee: If companies have to publish papers that can be read publicly it might lead them to have the PR department “proof-read” all of their publications, and that might impair the scientific quality of publications. That’s hypothetical, but might be a thing.

    • Cory Doctorow says:

       You need to read Goldacre’s book. More than half of pharma profits are spent on marketing — frequently criminal marketing, hence the rash of successful high-profile prosecutions for same. Of the remainder, the majority of research spend is on me-too and me-again compounds aimed at eking out new patents for minimally different compounds. And the pharma industry, which is wildly profitable, has completely corrupted the science of pharma testing, to the point where doctors today have literally NO IDEA whether they’re prescribing safe or effective medicine.

      Here’s a good excerpt:

      http://www.guardian.co.uk/business/2012/sep/21/drugs-industry-scandal-ben-goldacre

      • gsilas says:

        There is nothing inherently wrong with spending money on marketing.  If a business decides it can spend half of it’s profits on marketing in order to make more profits, that’s not corrupt.  In other words, money spent on marketing should not take away money from being spent on research (if the marketing division were not profitable, it would be downsized). The fact that among the largest fines in history against private companies have been levied against pharma for criminal marketing is the deterrent (perhaps those fines should be larger?).  It is baseless to assume that money spent on marketing is criminal or unethical.

        These me-too compounds are still BETTER MEDICINE; the FDA has very strict rules for approval of these compounds.  If they aren’t measurably better, then they aren’t approved.  You cannot imagine how difficult it is to design a first-in-class compound, trust me (not to under represent your imagination).

        Doctors should be better, yes, and as much as we’d naturally like to blame someone (i.e. pharma industry subversion of clinical trials), the problems that biology and medicine face have no comparison in our typically understood paradigms.  Medicine and biology is far too complicated to be clearly understood with current knowledge.  For example, we still don’t know why tumors respond to different chemotherapeutics, and we have no ability to predict which will be responsive.  This is NOT the fault of pharma subverting testing.  Also, we have NO IDEA the relationship between cholesterol and cardiovascular health.  There is even dispute about the biology of fructose and carbohydrate processing!  These problems have no comparison in the tech world, NONE.  It is not the fault of pharma that doctors have difficulty predicting responses to medicine.
        I’ve read parts of Goldacre’s book, but the fact that he has an agenda (everyone does), colors my conclusions.  As a scientist, I take personal offense to the broad strokes that he often paints, in particular when we have sacrificed so much of our lives in order to solve these problems for the greater good.  It hurts me just as much as seeing wrongdoing in the pharma industry (rarely perpetrated by the scientists, by the way, but by the marketing and businessmen).

        • Antinous / Moderator says:

          There is nothing inherently wrong with spending money on marketing. If a business decides it can spend half of it’s profits on marketing in order to make more profits, that’s not corrupt.

          There’s nothing wrong with dragging the greedy executives of the pharmaceutical companies to the guillotine and nationalizing the industry. If a society decides that the health of its members is more important than making a few people as rich as Croesus, that’s not inappropriate.

          FTFY

        • ” There is nothing inherently wrong with spending money on marketing.”
          … ” It hurts me just as much as seeing wrongdoing in the pharma industry (rarely perpetrated by the scientists, by the way, but by the marketing and businessmen)”
          … do you see the connection? Somewhere in this comment section someone complained about pharma companies employing fewer and fewer researchers.

          What this means (to me):
          The market (and the respond to the market all companies must, or they die) is shaped in a way that improving marketing is more profitable than improving the product. So what the customers pay for is marketing, not so much research.
          I think we can all agree that this isn’t good, but what would a new obligation to publish change in this respect? In my eyes, it would make it much more difficult for companies to replace research with marketing, because all the little lies would be exposed much easier, thus forcing them instead to spend more on doing  research and testing properly. Isn’t that a good idea?

          In most situations, people and organisations will follow the course of action that will most immediately profit them. The challenge is now to align that course of action with what they should be doing in the public interest, which is more good medicine and less bragging about it. And less deceiving people. I do not see how 1. an obligation to publish every clinical study and 2. an obligation to do this in open access form would impair any researcher working at a pharma company or trigger a company to reduce their research activities.

          … so what exactly is your problem with this proposal?

          • gsilas says:

            I don’t see how requiring the disclosure of clinical trials for unapproved medicines that will not reach the consumer will increase safety, this just seems to be to be another regulation that pharma companies will have to follow.  As far as approved medicines, current law requires the “summary” of clinical trials to be published, as I stated somewhere else in this thread.  I can see how public good would be increased if the full disclosure of results were required, yes.

            As far as the rest of your comment, your economics are broken.  Spending money on marketing, as I argued elsewhere in this thread, does NOT decrease spending on research.  Marketing divisions have to be profitable, or they would be downsized.  The current problem is that drug development is just too expensive to be worthwhile, hence the downsizing of R+D divisions.  After all, as you said, “organisations (sp) will follow the course of action that will most immediately profit them.”

            Currently consumers are spending the money not on marketing (for reasons above, marketing must be profitable), but the >$1billion it requires to develop a drug (current reliable estimates are up to $4billion each).  Unless drug development costs decrease, then R+D will be cut.  Requiring the publication of clinical studies would not decrease the cost of developing a drug, nor increase public good if that drug is never going to reach consumers anyway.

            I don’t see how “because all the little lies would be exposed much easier, thus forcing them instead to spend more on doing research and testing properly”.  If spending more on research was a good business decision, then companies would be pursuing it currently.  Marketing and R+D are decoupled arms of business.

          • First: I was probably a bit sloppy here: I was talking about publishing clinical (and probably not just clinical) studies relating to drugs that are being sold. Being forced to tell your competition what you’re working on and how you’re doing it is not a research incentive, I get that.

            Second: If the management of a supermarket found out they could make more money per square meter by turning the market into a parking lot and renting out parking space, then that’s what they have to do. This might impair the ability of residents to shop for stuff there.
            Do you agree?
            I think that in the same way, pharma companies realise that they make more money researching less and marketing more. They have a certain budget and find that giving more of it to marketing (and consequentially less to research) will make them more money.
            Meaning: Since it is very expensive to make a drug actually better than the competition’s, just market it more, and that will sell it.

            Yes, marketing pays for itself, otherwise they wouldn’t be doing it. No, Customers do not profit from more marketing, because it doesn’t make the product any better, and yes, customers do pay for marketing because all the money a company spends on it does come from the customers, this or that way.

            Now, about the decoupling of marketing and research: A company makes a certain amount of money each year, and that is what they can work with. They can also start borrowing more money, but doing that means having to reap more profits on that money that the interest they have to pay for it. Right?
            So, if they decide to spend more on marketing, how can that not impair the research budget? Granted, if companies thought that research was more profitable than it is right now, they would invest more in it. Apparently they think it’s not and they don’t.

            “The current problem is that drug development is just too expensive to be worthwhile, hence the downsizing of R+D divisions” Weeell, if you stop making new drugs, you’ll run out of stuff to sell sooner or later, or at least drug development comes to a standstill. Is that a desirable thing? Can marketing solve this problem? From the perspective of a company maybe, but not with respect to what the function of the pharma industry is supposed to be.

            The basic idea is making more objective information available to doctors and the public, thus allowing better informed decisions by the customers. Economically, informed decisions are absolutely necessary for a market to work properly, so what’s to say against that? This will also make it much more difficult for marketing to obscure the fact that one product isn’t actually new and another isn’t actually working. Thus making marketing less useful and by comparison making research more worthwhile. Win!

            I don’t think that marketing is amoral per se, but it isn’t adding value to a product either, it just makes it appear to look better. So if we want to improve stuff, just marketing it more is not a solution.

          • gsilas says:

            Since we seen to agree on the publishing of clinical trials, Mr. McKracken, and the discussion has shifted over to marketing vs. R+D, I’ll just drop these links and be out.

            In the Pipeline is the most well respected pharma blog, and I think these posts will be insightful for all parties who have commented on drug marketing on this post. http://pipeline.corante.com/archives/2009/07/08/how_much_does_the_drug_industry_spend_on_marketing.php

            http://pipeline.corante.com/archives/2012/08/09/getting_drug_research_really_really_wrong.php

          •  Point taken, and the posts _are_ insightful.
            About the marketing thing: Yes, it makes sense for pharma companies to market more. So from the POV of a pharma company it’s fine. I’m not sying pharma companies are stupid. Assigning character traits to people you don’t know is stupid.
            But that isn’t the question. the question is: Does it make sense for the public? Does it help pick the right medicine? Does it make medicine cheaper or more expensive?
            In an ideal world, the company will spend every dollar on effective R&D and on producing the drugs they develop, the customers (Doctors, mostly) will be automatically informed at no additional cost about any new products and their properties and thus make only well-informed decisions.
            That’s not the world we live in, so companies do need to market their stuff. What I’m saying (and the cost graph supports that!) is that if over 40% of the spending goes to marketing, we are farther away from that ideal world than we ever were and we should think about what will get us closer. In my view that can be done by putting more proper, fact-checked bits of information into the hands of customers more easily.
            Also, I wonder how much of that R&D budget actually goes to improving “cosmetic” properties of drugs… we’re not likely to get hard figures on that, but still.

      • “Here’s a good excerpt:

        http://www.guardian.co.uk/busi…”

        “This content has been removed as our copyright has expired.”

        I am somewhat dissapointed

  2. Oh my goodness, I can’t believe you fell for that argument for one second:
    Getting research money back by charging for access to the papers?

    Again, for everyone, please write it down and never get it wrong again:
    Authors of scientific papers _are_ _not_ _paid_ by the journals publishing their work and cashing in on it! Never ever. Politicians keep talking about how the authors need their money too, but for scientific papers this is not how it works. Full Stop.

    Meaning: The Public (or whoever finances the research) spends money to get results, they are being given for free to journals for the glory of having published stuff in a journal, and the company operating the Journal then cashes in on other people’s work. There is ZERO money going back into Research’s pockets.

    For Open Access of course, there is cash flow between research institution and Journal, and it goes towards the Journal, because, well, they do incur costs after all. And this is what is keeping many from publishing Open Access: Their bosses won’t spend money for it, when they may as well have it published at no cost to themselves.

    This is of course only a local optimum: If more people published with open access, those same research institutions had to pay less for commercial Journals and could spend the same money (or even less) on paying for publishing of their own research in open Access Journals, at the same time getting unlimited amounts of OA Literature for free. So far so great, but the money for literature and the money paid for OA publication does not come from the same cost unit, and while there are still commercial publications around, you do have to pay for those too, so on the whole it gets more expensive at first, and noone wants to go all in to discover they’re alone in OA land.

    This is why laws that force _everyone_ to use OA at least in certain cases are a huge help in this development.

  3. sqyntz says:

    it strikes me that the arguments for openness in pharma research has much in common with the arguments for openness in software.  namely, to allow the public to judge the security of software the source must be made available, and to allow the public to judge the efficacy of pharma products, the research must be made available.  without openness, the public is left to take the manufacturer’s word for it, with varying results.

  4. gsilas says:

    So, on the lack of publishing failed clinical trials: most all of those compounds don’t make it to market, so it is not harming public good with that information not being public.  They can’t be prescribed anyway, and won’t reach people!  Keeping that information as undisclosed IP is the right of the company, in my opinion.

    For failed clinicial trials that are related to drugs that are eventually FDA approved, this data should absolutely be published in the open.

    For clinical trials that are published, those trials should be designed to tell the complete story on drug safety and efficacy, so prescription of those drugs should be safe and scientifically proven.  Double blind trials should be designed to be logically infallible (if they are manipulative or flawed, the FDA should deny the drug).  For drugs that are approved following well designed clinical trials, that also have previously failed clinical trials relating to different disease markers or formulations or etc., these drugs can be prescribed off label and so it is absolutely in the public interest and good for full disclosure.

    Only roughly 10% of drugs that enter clinical trials are eventually approved and make it through the regulatory procedures.  So to say that unpublished clinical trials harm public good is absolutely misleading and inaccurate; only approved drugs with previously failed clinical trials (the vast minority of cases), should the data be required to be disclosed.

    • Cory Doctorow says:

      “most all of those compounds don’t make it to market, so it is not harming public good with that information not being public.”

      The clinical trials are tested on volunteers who risk their lives. Per various international protocols on human subjects, they have the right to expect that the knowledge gleaned from their bodies — including negative results — would go to wider use.

      “For failed clinicial trials that are related to drugs that are eventually FDA approved, this data should absolutely be published in the open.”

      And yet, about half of pharma-sponsored trials for FDA approved drugs are never published.

      “only approved drugs with previously failed clinical trials (the vast minority of cases), should the data be required to be disclosed.”

      This is untrue. All the research on trial starts and trial publication says that approximately half of industry-funded trials are not published. That figure includes compounds that receive regulatory approval for marketing in the public.

      • gsilas says:

        The risk that trial volunteers take on and the knowledge learned, does go to a wider use.  Typically, the failure of the trial.  I consider that very useful.  Perhaps it would be marginally more useful if the data was always published, but the outcome would not change (drug failure).

        As for the disclosure of clinical trial data for drugs that are marketed: because they can be prescribed off label, then opening the data would benefit society.  This certainly should be required.  I’m surprised that so few are published.

        Primary references regarding clinical trial disclosure:

        Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation
        http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050217

        Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis
        http://www.bmj.com/content/344/bmj.d7292

        “Enacted in 2007, the FDA Amendments Act requires the sponsors or designated principal investigators of nearly all non-phase I trials of FDA regulated drugs, biologicals, and medical devices to register their trials at inception within ClinicalTrials.gov. Critically, this law also requires public reporting of summary results among trials of FDA approved drugs and devices within a legally mandated timeframe, often within 12 months of trial completion, regardless of publication status.”

        Perhaps this should be made more stringent, with more than summary results required?

        Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis
        http://www.plosmedicine.org/article/info:doi%2F10.1371%2Fjournal.pmed.1000144

        Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis
        http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050191

  5. massspecgeek says:

    I think Cory is conflating two separate issues here and using the single term “open access” inappropriately.

    There may be a need to require pharma to publish all data regarding a marketed drug instead of cherry picking. That, however is not “open access” in the sense commonly used in the scientific community. “Open access” refers to access to publications without cost to the end user, usually by shifting the costs to the author. The most important thing would be that all the results are published somewhere, whether it be OA or traditional, as opposed to not being published at all.

    It also seems to me that there’s a serious flaw Cory’s justification for forcing this on pharma, when he says that pharma is asking for government certification of their drugs. This is backwards. Pharma didn’t ask for the Food and Drug Act — it was imposed on them. They’d be happy to market drugs without government certification. Very happy :)

    •  … I would still expect that you wouldn’t want to make them that happy. Actually, I think many people working for those companies might not be happy at all because they set out to create medicine and now they have to make snake oil because that’s more profitable.
      I think the only way regulation can work well is if the most profitable way of conduct (which is what a good manager must aim for in the interest of the company) is also the way that will profit the society most.
      I agree that there are two issues:
      One is making pharma companies publish OA what they publish already. This should be a no-brainer as it doesn’t cost much and brings instant benefits. It may discredit a few drugs, but those had no business being in the market in the first place.
      The other one is making them publish every study conducted for every drug they are offering on the market. This also seems like a good idea, because we want to know what we buy (back to economics: Customers need to be able to make informed choices, or they are meaningless), but how do would a government agency determine which avenues of research just didn’t yield any useful results and which ones must be published? I guess you could find a useful way of doing that by saying that clinical trials involving patients must be published. Those have to be announced and are registered anyway (since you can’t just do experiments on humans in your basement), so that should be accomplishable with little bureaucratic effort, too.

  6. gsilas says:

    Editors are paid by the journal, and frequently are primarily employed as professors in academia (perhaps to a fault).  The paper is then handed off to unpaid reviewers, who are professors in academia.  They should (but frequently don’t) put in due diligence in checking the science for accuracy and logical consistency.

    The quality assurance should be remarkably cheap, basically.

  7. Cory Doctorow says:

     Who pays for it? In the case of PLOS and other OA journals, it’s paid for by the researchers and their institutions. IOW: rather than paying $X for an institutional subscription, they pay $0.0001X to have some of their research juried by an OA journal. OA journals are now the gold standard in many fields, and have higher impact factors than their commercial competitors.

  8. Depending on the Journal, the costs of running it are incredibly low or (for the good ones) quite high, because they care about what they’re publishing.
    At the same time, subscription fees have skyrocketed in the last decade, with no cost increase for journals to justify it. They are increasing prices because they can. Because other researchers _must_ read what their colleagues have published.
    => Of course, running a Journal isn’t for free, but as of now, the money they charge is much much more than the costs they incur, and it’s mostly funded by public money.
    In an OA publishing model, you pay the Journal a fee for publishing your stuff, and that’s it. All costs covered, and if someone wants to double prices for no reason, you just publish elsewhere. That’s how economy should work in the first place.

  9. I wish I could agree to that. Asked my boss if he would allow some money for publishing my stuff with an open access Journal … nope, won’t. Too expensive. We’re paying through the nose for subscriptions already.
    At least i my field, everyone is extremely suspicious of those new fancy OA Journals, and because of that, no one reads them, and no one publishes in them, and they have to publish whatever they get, which is mostly of small relevance and not well done nor well written. Sad truth. Most people I know do not publish in OA Journals or are not allowed to, either.
    At least in the fields I’m aware of, OA plays a very very small role.
    What does happen is that some institutions (like the NIH in the US) force Journals to offer open access after some “protection” period, and there are more and more papers available to the public from otherwise non-OA Journals. I think that’s the way it’s more likely to go: Journals need to be forced by law to offer open access to more and more papers.

  10. This discussion is about whether pharmaceutical companies should publish papers in open access mode.
    For the party doing the research this means zero additional work and a few hundred dollars publishing fee per Paper. Since a clinical study would usually cost a few orders of magnitude more than that, the additional costs are negligible.
    Since other parties would then also have to publish the same ways, costs would even _decrease_ since the people doing the research would incur lower expenses for accessing other people’s papers.

    Your Point 2 is actually valid. And changing the regulation (for everyone, not just a select few) would change the rules of that game, and following them would make them play that game in a way that is closer to what they were supposed to do in the first place.

    If pharma companies sell stuff that doesn’t work and withhold the evidence, it’s not exactly benefiting patients either, is it?

  11.  Hmm… of course?
    If the thing you’re profiting from is the mashing and not the info itself, then why wouldn’t you?
    Companies sell Linux, and it’s viable business, because they’re providing the service of packaging and supporting the software. That’s what they get paid for, and it’s something everyone is allowed to do, thus creating an open, non-monopolized functioning market.

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