Glaxo To Give Away Malaria Drug Research

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andrew-wittyIn a carefully coordinated blitz, GlaxoSmithKline is outlining steps today to get in front of the controversial issue of access to medicines. CEO Andrew Witty is briefing various groups about plans to attack neglected diseases, starting with making 13,500 malaria compounds freely available to researchers on web sites and devoting profits from its experimental vaccine.

“This is the furthest anybody’s gone; nobody has put in the public domain the product of a 2 million screen” of small molecules, Witty tells Bloomberg News. “These are essentially the building blocks
from which all of our drugs eventually come.”

Glaxo will limit its profit margin on the vaccine to 5 percent and contribute proceeds to its tropical disease research budget. The drugmaker also is creating an “open lab” in Tres Cantos, Spain, where 60 outside researchers can use its equipment and collaborate against tropical diseases; provide $8 million to establish a nonprofit foundation to help fund research, and award $2.5 million to health advocacy groups working in Africa to fight malaria.

Timothy Wells, chief scientific officer of the Medicines for Malaria Venture, which has been working with Glaxo, tells PharmaTimes “the research community can start to build up a public repository of knowledge that should be as powerful as the human genome databases…set a new trend to revolutionise the urgent search for new medicines to tackle malaria.”

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  1. This sounds like an exciting start to an honest attempt to help the worlds poor in underprivileged areas of the world to benefit from technology and innovations.

    Fingers are crossed that the strings invariably attached to this deal, do not become the hangman’s noose for fellow humans…..

  2. Funny how positive news from the industry elicits no response, but anything to do with bad apples in an industryn garners response about how evil the industry is….

  3. Josh–Why do you think that is? (My usual question to which I almost never get an answer.)

  4. Actually Josh,.. I had been treated with one of GSK’s anti malaria drugs which was quite effective. But with that said, GSK should be held liable for the harm and death in children that their antidepressant Paxil created.

  5. Hi JiM
    As you asked me the same question recently (which I did not answer) I’ll offer my view. Pharmalot is seen daily by thousands of viewers from all walks of life: I expect some are pro-industry, some anti-industry, and the majority in the middle. I suspect that Josh is expressing the same frustration that I and other occasional commenters feel (in the minority I think) in that many of the comments here are predominantly anti-pharma. Some are well-considered and cogent. Others less so, but most comments seem driven by some sort of agenda, whether it’s a whistleblower, someone with personal problems related to medicine or its effects, conspiracy theorist or whatever. I can’t speak for Josh but I have been visiting Pharmalot since day one - as have you - and have become increasingly frustrated at the tone of the comments. Whereas once there seemed more discussion and willingness to debate, now there is less civility and apparently people with endless hours to spend here shooting down anything that smacks of ‘pro-pharma’.

    I think Pharmalot is excellent and that Ed does a fine job. It’s the relentless diatribes about how evil is pharma which, for me, make the comments less interesting than they once were. As Ed is fond of saying, Pharmalot is like a house party where you can mingle and spend time with whichever group you choose. Just seems a little harder now to avoid the ones you don’t.

    Chris

  6. Chris–Thanks for taking the time to respond. I totally agree that one of the great things about Pharmalot has been the opportunity to have genuine discussions of policy and related issues. There is no other such site, as far as I know.

    So I share your concern that we could lose that here. My sense has been that there may have been a kind of snowball effect. People like you, Atlex, and others depart–perhaps in response to other posts–and that becomes self-fulfilling. I understand some folks reappear under different pseudonyms.

    In any event, thanks again. We may not always agree on issues, but we agree on what Pharmalot has been at its best.

  7. Christopher,

    I have to respectully disagree with you. I believe, since Pharmalot’s Reincarnation, that the tone here has become much tamer. I also believe, that a consumer, should be given all information in regards to the safety and efficacy of the medicines they are prescribed. Years ago I wouldnt have thought twice about, or questioned what my Physician was prescribing and why. A perfect example, my prescriber wanted to prescribe phenegral, to counter nausea from a medical procedure, I chose Mylanta instead, because, taking an antipsychotic for nausea isnt my cup of tea, it’s about making an informed decision.

    Also, since the birth of my grandson, I have been so busy that I dont have the time to sit at the computer all day.

  8. One more thought,.. At least when I post, I use my true Identity, unlike the majority who post here.

  9. Hi Lisa,
    Fair enough - just my opinion.

    And congratulations on the birth of your grandson. I am certainly grateful. :-)

  10. It’s the old story. Positive news stories are less newsworthy to an investigative journalist. There is also a space issue. When Ed worked for the Star Ledger he had the ability to explore these issues in great detail, presenting many sides of an argument. It’s impossible to do the “fair and balanced” thing in a blog, which I accept. Positive news stories tend to be yawners. So what if the pharmaceutical industry has given away billions of dollars woth of drugs to third world countries, or has enterered non royalty-bearing licensing agreements to sell generic versions of HIV drugs in Africa, basically selling them for at or below cost. On the other hand, when a company like Abbott raises the price of Norvir in the U.S. to try to make up some of the lost revenue, it then becomes newsworthy. In an investigative news article we would hopefully get both sides of the story. In a Pharma blog we usually get only the negative side.

  11. Christopher,.. I respect your opinion and Thank You, he is absolutely amazing.

  12. pharmavet - I agree but just to be clear it is the anti-pharma dogma in many of the comments which I find a turn-off, not the editorial.

  13. I second Lisa’s statement that things are actually a lot cooler in the current edition of Pharmalot. And, IMHO, there are quite a few more pharma apologists, though none to approach the level of dear, old horuscat (was that her name?). But rather than engaging in the discourse, with the exception of Atlex, you just seem to whine about how everybody is so mean to pharma. And I’m looking at you Christopher, and Josh, and that Michael Hirsch guy. Some of us have to read about pharma’s misdeeds day after day and some of us have been seriously injured in one way or another by same. Why should people not be able to have their say? Who’s stopping you from getting on here and crowing whenever pharma does something good? Who’s preventing you from starting your own blog about how amazing pharma is? Why aren’t you reading DrugWonks if that’s what you want? I mean, really, what gives you the right to come here and cry that people aren’t being as nice as you’d like to your favorite team? Have you ever stood up and said “damn, that was a horrible thing to do” in response to one of these stories?

    But I also think you side-step the real point. Among the so-called “anti-pharma” crowd there are few of us who are truly anti-pharma. We are anti-lies, anti-crimes, anti-obfuscation, anti-misdirection, anti-ghostwriting, and anti-someone making a buck off of my pain and suffering (or a loved one or some poor schmoe from down the street ‘cos there for the grace of god…). So, if pharma wants to step up and toe the line, sell drugs that actually work for what they’ve been approved for, get approval for indications they want, stop lying about side-effects, stop selling drugs for illnesses they don’t work for, etc, etc, I think we’d all be happy to do something else with our time.

  14. JiM - Human nature. It is more interesting to rubberneck at the train wreck.

    This program seems to be the equivalent of open source programs for computers, which pretty much never happens in the pharma industry. Anyways, you really don’t hear pharma tooting its own horn when it does positive things (and it does happen more than you know). A secondary issue is that the moment money, goods, or technology is given away to institutions or people regardless of use or stipulations, people yell conflict of interest (I am surprised the money and drugs given away to Haiti hasn’t been labeled as industry trying to dig its claws in…).

    And, the reason why most people in the industry don’t post their true identity is that most of us are not official spokespeople and could be reprimanded. I personally enjoy my privacy and don’t want the publicity.

  15. And Harpy…I don’t disagree with you that pharma needs to follow the rules. I also agree about the “anti-pharma” crowd, but then again I know very few in the industry that are pro-lies, pro-crime, pro-ghostwriting, or pro-enjoying people’s pain and suffering. Most of us in the industry are there making medication to treat ill people. At the company I work for we follow the mantra that “we are here to meet the needs of our patients”. I can’t speak for all of pharma, but that feeling is pushed down from our president down to the guys working a tablet press.

    You read the misdeeds of pharma every day because that is what sells. What do you hear about healthcare reform right now? You hear all the naysayers, because they scream the loudest and yell about the gloom and doom of the ramifications of changing the system.

    I did post in the bipolar kids topic questioning how they are diagnosing bipolar in a 2 year old (mainly because I have a rambunctious 1 year old at home). You have to remember that most of us in the industry have kids, parents, husbands, and wives. We don’t want to hurt or even possibly kill them with the medication that we make.

  16. Josh,

    Excersizing one’s right to free speech is wonderful and has nothing to do with publicity, and believe it or not, I do respect one’s right to privacy also. I had the option to be anonymous, but chose not too.

  17. This has been an interesting discussion. As someone who has spent my entire adult career in pharma and was very pro-industry until this past year due to events I witnessed personally, I especially liked Harpy’s comments.

  18. And in my company the patient always comes first. Industry gets tarred with a broad brush, but they have a captive audience which makes them more responsible for living up to the demands placed upon them. When it comes down to someone dying or a stock price dipping, well, we’ve seen the choice some companies will make. But they can’t be allowed to do horrible things and get off by saying they did something nice for someone.

    Reminds me of a quote (can’t remember who said it): “If you’re gonna be bad, you may as well be all bad, because if you’re half bad no one remembers you’re half good too.”

    Conversely, if you wanna be good, be good.

  19. harpy thanks for the thoughtful reply. I’m not sure anything I could add would demonstrate my point any better than you did, other than to point out - as I have before and in many discussions - that I am not a pharma apologist, simply someone who welcomes reasonable discourse as opposed to indiscriminate, unsubtle and bilious “broad brush” tarring of an entire industry.

  20. The aniti-pharma crowd on this board chhoses to live in an alternate reality in which they envision a Utopian world where all drugs would have 100% efficacy with no side effects. This vision prevents them from arguing coherently and in an intellectually honest way. Those of us in Pharma (at least on the scientific side) are trained in rigorous thinking, methodical analysis, and intellectual honesty. We choose to see the world as it really exists, and try to improve it, rather than put up straw men and throw brickbats.

  21. Glad we got this discussion going, at least.

    In Pharmalot I, there was (in my view) an excellent thread in which a number of industry people spoke candidly about the _changes_ they saw over their own time in the business. (I’m too lazy to look up the thread.)

    Those who posted mostly concurred that several factors coalesced–the increasing influence of marketing over research within companies; a self-fulfilling “race to the bottom” in competition between companies (”everyone is doing it”); the inherent temptations of the blockbuster model, particularly in the context of a weak and/or captured FDA and the pipeline problem; the then very rare DOJ-initiated sanctioning; and much more….

    None of this suggested that people who work in the industry were any less ethical than in other lines (many of us ‘outsiders’ have suggested the opposite). Likewise, in most of the truly scandalous things that happen, it is a very small number of people in a company who are involved. I think most people here understand that.

    The key difference, I think, is what is at stake, and the consequences of even small “envelope-pushing.” As I’ve said, nobody cares if a sociologist ethically f’s up. When a drug company does (or a part of it), a great deal of irreparable damage can be done.

    To that extent, it’s docs, priests, and others on whom we rely in unique ways get the same intensity when things go wrong–and few suggest that it’s “unfair” that people talk less about the “good things” the church and physicians are doing.

  22. Vet writes: “We choose to see the world as it really exists, and try to improve it, rather than put up straw men and throw brickbats.”

    Regarding most (but not all) participants here, I believe this is itself putting up a straw man and throwing brickbats.

  23. by golly, JiM, you beat me to it! :)

  24. Check out what The Motley Fool has to say about Glaxo’s announcement: http://www.fool.com/investing/general/2010/01/21/the-noble-gesture-that-wasnt.aspx

  25. I certainly can’t fault the likes of GSK and Bill and Melinda Gates for their philanthropy. But perhaps their resources would be better directed at eliminating the environment in which diseases flourish, rather than by providing inexpensive drugs and vaccines to the Third World.

    What if Pasteur’s Germ Theory of Disease is wrong? What about the risk of promoting antibiotic resistent and antiviral resistent microbes throughout the Third World?

    “There are no specific diseases; there are specific disease conditions.” - Florence Nightingale

    “Illnesses, hover constantly above us, their seed blown by the winds, but they do not set in the terrain unless the terrain is ready to receive them.”—Claude Bernard.

    “Bernard avait raison. Le germ n’est rien, c’est le terrain qui est tout.” (‘Bernard was right. The seed is nothing, the soil is everything.’)—Louis Pasteur

    http://www.whale.to/v/nightingale_h.html
    http://www.theadjustingroom.com/Weekly%20Reader%2020%20February%202009.pdf
    http://www.webmm.ahrq.gov/perspective.aspx?perspectiveID=62

  26. This is not directed at any particular person, but about a concept. We hear, as above:

    “The aniti-pharma crowd…chhoses to live in an alternate reality in which they envision a Utopian world where all drugs would have 100% efficacy with no side effects.”

    No. Those who speak critically of particular episodes are usually asking some version of the questions:

    1. What did they know?
    2. When did they know it?
    3. What did they do?

    It is certainly true that answers to such questions can often be complex and open to a range of plausible interpretations. But the “Utopian world,” as described, is something I’ve never heard or imagined here.

  27. I’m going to go out of character and say something controversial: The Hatch-Waxman Act of 1984 was a huge mistake, and ultimately the cause of most of the problems discussed on this board.

    When I was a kid, pharmaceutical companies produced new products, ran the clinical trials, and sold the products for (by current standards) affordable prices in perpetuity without generic competition. Henry Waxman thought these prices were too high, and decided to fix the system by making it easier to bring generic drugs to market. The Hatch-Waxman act dramatically lowered the bar to generic market entry by allowing generic companies to use innovator companies’ proprietary clinical trial data to obtain approval of their products.

    So, pharmaceutical profits plummetted and consumers saved tens of billions of dollars per year, right?

    What actually happened is

    1) As one might have predicted, innovator companies raised the prices on patented drugs to replace the profits lost due to generics.

    2) We created two classes of patients. Those who use new pharmaceuticals in the first 10 years or so they are on the market (who pay out the nose and thereby provide the innovator companies with their return on investment), and those who use them after they go off patent (who pay only for the cost of manufacturing).

    3) We created an industry made up of large cap companies that derive most of their profits from 3 - 5 products (instead of say, 20 - 30), each of which can only be replaced by a risky, extraordinarily expensive, 10 - 15 year development process. Isn’t this pretty much the definition of moral hazard?

    Realistic, thoughtful, respectful comments will be responded to in kind.

  28. Hello John —

    In that mythical land bounded by “reality“, “thoughtfulness” and “respect“. . . I offer an earnest question — in reply to yours:

    Do you really, thoughtfully and respectfully mean to suggest that LONGER periods of patent monopolies on live-saving drugs would SOLVE any of the ills you’ve perceived?

    I am sorry, sir, but I cannot even conceive of a straight-faced argument in that direction. Yours is a classic non-sequitur.

    If I’ve misunderstood you, please elaborate.

    Otherwise, there is little point or purpose — to addressing your supposed con-numb-drum.

    With all due respect,

    Namaste

  29. Hi John–Deal. No silly. No horse products.

    When was this halycon era when you were a kid? Serious questions. As you know, the Kefauver-Harris amendments were originally about price fixing. It was only after thalidomide that they turned out to be about safety, efficacy, and scientific evidence.

    The Senate hearings of the late seventies were largely the same.

    Anyway, taken from another context, here is my own summary about the structural sources of “moral hazard.” As you’ll see, many of the points are the same, or close, to yours:

    “There are certain structural features in the industry that make it extraordinarily easy to “stray.” These include: the always-ticking patent clock, the “blockbuster model” on which company’s entire annual sales depends on the fate of a few products, an enormously competitive marketplace which is not conducive to the highest standards if a company is to fare well (often bemoaned by CEOs themselves); a relatively malleable FDA; the “evidence-free zone” before a drug’s full array of risks and benefits are known (which may be a number of years); the ease (and sometimes accuracy) of demonizing one’s “enemies” (trial lawyers, ambitious politicians, muckraking journalists, etc.); the ease of resting on the laurels of the good things one’s company has genuinely done; and the fact that the great majority of people will continue to rely on the industry, whatever problems arise. Given these and other factors, it is, in a way, surprising that things go as ethically well as they generally do.”

    Given the factors that go beyond H-W, I’d like to see anything more that can help us understanding the impact of H-W in particular; and that shows, reasonably enough, that its costs (which are real) outweigh its benefits (which I believe are also real)

  30. To slightly echo part of JiM’s (of the supposed “halcyon days“) — there was in fact (after the middle of the last century) — never a time when drugs were proprietary, in perpetuity.

    It may have seemed like it, but it was not so.

    So when one departs from a false premise, all the rest falls, of its own weight.

    Namaste

  31. I’d just add this to my list of “temptations” toward moral hazard…

    The relative meaninglessness of most external sanctions with the possible exception of very large product liability lawsuits (like fen-phen’s $20B). Otherwise, as has been noted, even the highest penalties can be “folded in” in a number of ways.

    All that said, I would certainly be interested in thinking about ways of adjusting the system so that extending exclusivity might be a “reward” for other things–no fraud/negligence violations over a period of time; appropriate ROIs (understand can of worms); and so on. I see nothing sacred in any aspect of the incentive/discincentive strucure that could not, conceivably, be changed.

    The discussion will come down to chicken/egg type questions. On the farm as it stands, I’d change the barnyard first and see whether, indeed, we see changes in pricing, quality, significant innovation, amount of malfeasance, etc.–all that we’ve been promised over the years if we only got rid of (you name it): FDA, product liability, limits on off-label promotion, Hatch-Waxman…..

  32. Condor,

    Not respectful –> no response.

    John

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