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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: Twitter: Dereklowe

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February 2, 2009

Open Pharma?

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Posted by Derek

Several readers pointed out the comments of Paul Stoffels, head of R&D at Johnson & Johnson, as reported in the Wall Street Journal’s Health Blog. He’s boosting some sort of open-pharma research model, although what he means by that isn’t too clear:

“All simple diseases have been solved,” Stoffels said. “The next-generation drugs, therapies, are much more complex… You need much more information and science than what you can get out of your own internal labs.” . . . The future of the drug industry, Stoffels told the Health Blog, is “building networks where together with a number of different groups you come up with solutions to solve different medical needs.”

There are a couple of things worth noting in there. The comment about all simple diseases having been solved, for example – people in the industry make that point (I’ve made it myself), but is it true? Forced to choose, I’d say that it’s more true than not, but I’d also point out that even the “simple” diseases aren’t so simple, in retrospect, and that we should think hard before we start trying to put together any list of diseases we’ve “solved”. I’m trying hard to think of some right now, and I have to say, the list slows down once you get past polio and smallpox. We’ve been able to improve a lot of bad situations, but “solved” is a strong word. Blood pressure? Heart disease? Definitely helped, helped a great deal, but “solved”? I don’t think, for example, that insulin solves Type I diabetes.

As for the network thing, this doesn’t seem that revolutionary to me. Drug companies have been bringing in all sorts of collaborators to help out with development. The fallacy in this is, though, thinking that the information you need to make a great drug is always out there. To me, that’s one of the hardest parts about drug discovery: the way that some of the most important factors are still black boxes. What “different groups” can you bring in that will predict that failure in two-year rodent tox, which hits you in Phase III? That said, one important benefit of getting different eyes onto a project is to break up group thinking, and that goes for every stage of a project. Those things that Everybody Knows can really come back to bite you – in advanced stages, you get things like Pfizer’s billion-dollar forecast for their inhaled insulin disaster, Exubera.

The comments to the post make the usual analogies to open-source software development. That breaks down, though, when you consider that the resources needed to write code are a lot easier to distribute than the resources needed to discover drugs. NMR machines, animal labs, and compound repositories are a lot harder to scatter through a thousand basements. . .

Comments (36) + TrackBacks (0) | Category: Drug Development


1. RB Woodweird on February 2, 2009 8:25 AM writes...

I think he means that you are all welcome to contribute to his projects in exchange for a warm and hearty thank you. Because profits are, of course, closed source. Fiduciary responsibilities and all that, you know.

As we used to say in the lab: What's mine is mine and what's yours is ours.

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2. MikeyMedChem on February 2, 2009 9:00 AM writes...

Love the model...until one has to grapple with the concept of "OpenSource IP".

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3. Milo on February 2, 2009 9:17 AM writes...

NMR machines, animal labs, and compound repositories are a lot harder to scatter through a thousand basements. . .

True! But maybe this lends support to the idea of having more drug discovery being done in the academic and government lab arena.

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4. You're Pfizered on February 2, 2009 10:11 AM writes...

If the trend continues with consolidation followed by the obligatory job losses in Discovery, government labs might have to be a consideration for simply employing the thousands of unemployed drug discovery/development scientists....

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5. Annon on February 2, 2009 10:28 AM writes...

They already are. Talk to NIH and CMS.

What is the proportion of hardware to labor that might distinquish pharma work from IT... or music?

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6. Hap on February 2, 2009 10:40 AM writes...

I don't think the IP is a problem - you don't have any. But software doesn't have cost of goods, either - how do you get a manufacturer who is going to commit large facilities and process people to processes from which they can't make money? The people who pay for the animals and supplies are going to want money (I don't think the FDA'll take in silico testing as a substitute), as well as probably those working on people. In addition, there probably aren't enough basement labs to support the discovery research - they're harder to maintain than a computer, and more subject to regulations.

This seems like a bad idea to anyone but upper management - "I'd like to have someone research my projects and send me the finished drug for free." At least Innocentive (whose projects look too much like full research projects) pays someone. Somehow this doesn't seem to fit so well with the "open/free software ethos".

I think the "cost of goods" thing is what distinguishes pharma from music - no matter how you slice it, you have to deliver a physical drug to your patients. Oh, and I'm pretty sure Saint Anger did not have to undergo major trials in humans - I'm pretty sure it failed in Phase 0 (or should have).

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7. anon on February 2, 2009 10:46 AM writes...

"thousands of unemployed drug discovery/development scientists...."

The trend is clear: in 5 years Big Pharma will do zero research in-house; it'll be all about acquiring start-ups and using domestic CRO's (for quality reasons). This model only works if the VC system gets "fixed" and starts funding stuff more sophisticated than "stick a lipid on an insoluble drug".

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8. Ben on February 2, 2009 11:52 AM writes...

Open-pharma is an interesting idea, but I think it's one doomed to failure. Derek points out great reasons for this (e.g. clinical trial success has next to nothing to do with collaborative "IP"), but I'd also argue that the computing/semiconductor industry has shown that ridiculously challenging problems don't require an open solution. The meltdown of Sun Microsystems, the fact that IBM makes most of its money in software/services sales (which may leverage but is not open source contribution), and the fact that Intel is still at the forefront of semiconductor process technology strongly suggests otherwise.

This is not to say that open source and collaboration aren't useful (Intel/IBM have plenty of collaborative/open-source projects), but unlike evolution and global warming, I think the jury is still out (or may have already decided in the negative) that "open source" is the solution to all innovation dilemmas.

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9. milkshake on February 2, 2009 12:28 PM writes...

The excuse that "all low-hanging fruit has been picked up already" is ridiculous. Look how few tools research groups had in the past, how much more difficult was to synthesize and screen the compounds, and the overall productivity was still higher. It is a cliche repeated by lousy managers that have to answer how come with all modern tools and all this huge funding Big Pharma became so unproductive. All these successful "easy" projects are easy only in retrospect.

If more projects started with animal-based and cell-based assay and screening of limited set high-quality compound collections, and if the management was less imbecile, and FDA less bureaucratic, the success rate would improve.

In 70s and 80s when Pfizer used to have a good in-house research, the group that succeeded with first oral azole, Fluconazole, found the drug only because they decided to test all their compounds directly on a relevant disease model - they actually fed all their compounds directly to guinea pigs to see if they could halt Candida vaginal infection. Since they could not test too many analogs in this assay and they knew that greasy azoles had lousy systemic availability they limited themself to small and less greasy compounds. In this way they found good compounds that other groups working on azoles missed (by focusing too much on optimizing the in vitro potency).

Lyrica was developed by a small academic group at Northwestern Uni, based on a mechanism insight that turned out to be completely wrong. Nevertheless one of the compounds from the series turned out to be surprisingly good in mice model done at Parke-Davis.

Paul Janssen directed his group to search for compounds with anti-psychotic action by looking for compounds that can reverse symptoms of amphetamine intoxication in mice. This idea was based on a simple observation that professional cyclists doped to their gills acted similar to delusional paranoid schizophrenia patients in their active psychotic phase. Janssen group quickly discovered Haloperidol.

So if a fairly small research department - in early 1960s - can find a good drug for such a notoriously hard disease like schizophrenia, we should be able to do much better now

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10. Pfizerite on February 2, 2009 2:39 PM writes...

Milkshake, I agree with you but what would my four layers of site managers reporting to 3 layes of corporate management then do?

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11. CMC Guy on February 2, 2009 3:21 PM writes...

I likewise have problems with the "low hanging" arguments, mostly because majority of the searching has been in the wrong orchards: The Blockbuster mentality that has predominated since the 80s geared programs away from small programs/diseases that have largely been left out, even with orphan drug status attempting to encourage such targets. Biotechs have not been immune to seeking only the big markets. Cancer(s) is about the only field that has significant exploration toward smaller patient populations but is typically because failure to get traction in larger occurrences. Unfortunately the base cost and Regulatory burdens have gotten so high, then combined with pressures of control pricing/patent expirations, its hard to approach any project with confidence that will have positive ROI.

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12. Totalsyn on February 2, 2009 3:28 PM writes...

Hmmmm, the so called "chemical space" is practically infinite. We have barely scratched the surface when it comes to exploring it. We've only gone after compounds that are relatively easy to synthesize. Management and investors simply don't have the desire to allow us to to progress further in this regard because of the costs, time and repeated failures that must be incurred. And so here we stand.......

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13. Hap on February 2, 2009 3:50 PM writes...

12: Feed lions? Or is that animal cruelty?

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14. milkshake on February 2, 2009 4:22 PM writes...

The funny thing is, synthesizing compounds and testing them is not too expensive, compared to a late-stage clinical failure. Animal testing is not as expensive either, considering how easy is to take a wrong turn in a project that is guided by the in vitro data alone.

The problem with the typical pharma is that the top management makes unrealistic promises to please the stockholders (I was at Aventis when they kept saying their company goal was 4 IND per year, every year) and this self-serving bullshit flows down, and only agreeable stuff flows from the bottom up. Eventually becomes sluggish and the management style turns into ideology-based ritual, much like in the communist party, smooth talking charlatans and courtier get promoted to lead the projects and reap the rewards etc. The whole model is corrupt and decoupled from responsibility and the stock-holders don't have much understanding into what kind of swamp they are putting their money. Retail business operating on the same principles would crash within a year but in pharma business it takes decades.

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15. DC on February 2, 2009 6:52 PM writes...

Insightful comments Milkshake.

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16. MoneyShot on February 2, 2009 7:30 PM writes...

milkshake, you are spot on. Promotions now are based upon who is agreeable and can bobble head the best. What happened to results based organizations? Why has failing forward become the norm at big pharma? At big/mid sized pharma research is dead, the only place where good novel research can take place is biotech, and only there because it is not crushed from above. In a small company, every team member has to pull her or his own weight, and people can not hide behind others results.

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17. FromTheInside on February 2, 2009 9:10 PM writes...

Perhaps I've been gone too long, but the pipeline at JNJ has been horrendous for years. Without the acquisition of Centocor, it would have been even worse. The acquisition of Alza was an abject failure. Innovation was using a side-effect from SSRIs as a label indication - prevention of premature ejaculation. Follow-on drugs have languished during regulatory review and sales have been tepid if they are approved. Suffice it to say that I look at comments from JNJ with great skepticism. Rather then comment to the outside community, more work needs to be done to demonstrate thay they have control of their organization first. Only then can credibility be established.

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18. S Silverstein MD on February 2, 2009 10:55 PM writes...

Physician perspective:

Regarding most chronic conditions, we have "solved" nothing. If we had, they would no longer be "chronic conditions", after all.

We have remediated the very worst effects of these conditions, such as vastly reduced lifespan, short term organ failure, incapacitation at early age, etc. However, we have not "solved" many other issues regarding morbidity and somewhat earlier mortality.

"Solved" is a marketing term. It is disconcerting to hear such language from a pharma R&D head.

Then again, hospitals have been overtaken by the marketing bug. Today a local hospital here in Philly used a story of a middle aged man who loved to go out with his wife, but whose "heart had now gone out" in a prime time radio advertisement. You know, the ads with those tear jerking, slow piano note tunes in the background.

The hospital treated him with a heart transplant, and now he can go out with his wife again and happily "look forward to a bright future and the rest of his life" or words like that.

Pure marketing spin. His problem was "solved", except for those pesky and complication-prone anti-rejection drugs and tests he needs to regularly take.

I thought the ad both a waste of time and offensive, offensive in giving people overconfidence and the false impression that modern medicine could "solve" anything with no risks or "gotchas."

Such statements from R&D leaders (scientists, I presume, although perhaps a bad assumption these days) - and hospitals and physicians - do not serve the body public well.

The "network thing" sounds like Good Scientific Practice 101. Disciplinary and organizational insularity is not a good business practice in biomedicine.

However, I get somewhat depressed when I hear highly paid heads of huge companies sounding like the creature that pioneering heart surgeon Victor P. Satinsky referred to as the "Master of the Obvious."

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19. ds on February 2, 2009 11:04 PM writes...

"networks where together with a number of different groups you come up with solutions to solve different medical needs.”

Yes, drug development can only be done within organizations that have the necessary resources (chemistry labs & analytical equipment & animal study facilities).

However, target identification can be done via an open-source collaboration. If one compares the genotypes of all the people who test themselves via 23andMe and/or deCODEme and investigates if there is a correlation between a specific disease and a specific SNP, then the gene (protein, enzyme) in which this SNP is can be investigated as a drug target to treat the specific disease.

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20. milkshake on February 2, 2009 11:42 PM writes...

Target identification is not worth that much until you got some assay - that means a purified stable form of the protein, antibodies, engineered cell lines, knock-out mice etc. These things take serious money and effort to develop, its not like writing an updated version of software. And the potential pay-off is huge also. How do you deal with freeloaders and egomaniacs who use the work of others to get their own patented drug candidates - without giving back to the community? It is my experience that when you have potentially tens of millions worth of IP at stake (and patent lawyers advice) the behavior usually changes for worse. Unless there are clear rules and giid leadership the whole open-collaboration thing can end up in courts.

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21. pfizerite on February 3, 2009 1:19 AM writes...

Milkshake once you have the candidate compound with in-vitro and in-vivo data, the real money starts at the clinical stage. I do not know if any rational person would start clinical trials without a strong patent position so that they can reap the benefits of success and freedom to operate because they don't want to share with others the benefits they have reaped. Open collaboration is great as long as the pay off is going to go to the parties that fund the clinical trials.

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22. Tristan on February 3, 2009 1:28 AM writes...

I'm not a chemist but a computer scientist, so I'll try to provide an alternative POV here.

First, the resources necessary to develop open source code, esp. by first-class programmers, is far from free. Most of us own several thousand dollars of personally invested equipment. Internet and hosting isn't free either, just cheap (~ $450 a year for me). Those who are into the embedded and open hardware side of things even more invested (ex: a good oscilloscope will run a few thousand, and that's just one piece of lab equipment). And yet, despite all this, open source and open hardware is starting to take off. So much so that what used to be tens of thousands of dollars per seat of necessary equipment is now free or costs less than an iPod.

I'm putting forth this hypothesis: it's not about the lab investment or the time. It's all about the dissemination of information. Lab cost is high investment but low maintenance cost. Time is actually free (grad students are cheap and people like to have hobbies). It's the information that's actually important for building things. Software simply takes information reuse to an extreme (DRY, libraries, interfaces, code reuse, etc) and it can be implemented with what is now considered ubiquitous (open source started long before the PC was invented).

I'm not sure if an "open pharma" can exist because I'm not a chemist, biologist, or anything dealing with a white lab coat over a beaker. I sure hope it can because of the obvious benefits. Besides, hard sciences have long held (read: predate) the core concepts of open source. IMHO, scientific journals are proof of this.

Now for some comment response...

Ben said:
> The meltdown of Sun Microsystems, the fact that
> IBM makes most of its money in
> software/services sales (which may leverage but
> is not open source contribution), and the fact
> that Intel is still at the forefront of
> semiconductor process technology strongly
> suggests otherwise.

Sun's meltdown is a great example of why open source is successful. Sun's primary product was their custom hardware running their custom OS (Solaris). Commodity x86 servers running Linux blew them away. They're now in catch-up mode with OpenSolaris, OpenSPARC, and so on.

IBM has always been a service company. They've been that way since the early 1900s, and often they've given source out as part of their large contracts. IBM makes bucks with Linux in part because it fits their long-standing business model.

Intel is a hardware company, not really open source. If open hardware takes off more than it has then I'm sure they'll feel threatened. As it stands, attempts to make RISC CPUs are met with aggressive patent lawsuits from stupid patents (thanks a lot MIPS and ARM). Hardware investment for top-end performance CPUs and GPUs is far too expensive (millions in lab cost). That said, Intel is diving head-first into open source. It's a key part of their GPU division, and Intel recognizes AMD's success of the 64 bit x86 architecture was due to open source (Intel's attempt sucked and AMD's won thanks to Linux and BSD). Intel is a player in open source because it doesn't want to be caught with its pants down. That and it's a hardware company; hardware is completely useless without software. ;-)

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23. MTK on February 3, 2009 8:43 AM writes...


This is where the disconnect is. Your investment of "several thousand" and internet hosting of "~$450/year" is essentially free in our world. To give you an idea a basic NMR instrument runs into seven figures. A state of the art MS instrument is multi-millions. Those things don't run themselves either. Well, not for long. In order to protect that investment, someone has to care and maintain them. Start adding expenses for basic things as reaction glassware, chemical supplies, and hazardous waste disposal. When you start adding it up your $450 would last us about four reactions.

As for hobbyists, there's really no such thing. Not in terms of real research. Only meth labs and few other dabblers, but the hobbyist/gentleman-scientist hasn't been seen in chemistry since Victoria.

That's not too say some sort of "open source" couldn't work, however. Perhaps a consortium of pharma companies funding research in target ID and validation. Those targets would then be available to everyone within the consortium. Each company would then be left to its own to find the molecule or entity that best acts on the targets or pass on the target altogether.

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24. MTK on February 3, 2009 8:58 AM writes...

Ooops. sorry, ds. Didn't see your comment on the target ID also.

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25. Mat Todd on February 3, 2009 9:39 AM writes...

The original article isn't really about open source, but appears to be suggesting merely that industry should collaborate with academia...

However, there are already moves to try the open source model in science. Our site, The Synaptic Leap, has projects in neglected diseases in chemistry and biology. Jean-Claude Bradley's site (Usefulchem) runs an 'open notebook' approach to collaboration in science. These are both experiments to test whether wet lab science can be done a) in a massively collaborative mode, and b) in an open way, where problems are solved by the iterative improvements of many contributors.

Given the number of chemical/biological labs containing copious amounts of equipment, and given some graduate student with some free time (opinions vary on that one, but if Google can grant employees time for their own projects, why can't we?) I see no reason why fruitful collaboration, using the internet as a medium, is not possible. There are challenges, e.g. we need tools for effective data sharing/management. But the approach is sound, and very exciting.

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26. Tom Womack on February 3, 2009 9:49 AM writes...

The open-source model is basically a straight-to-generic one, and as such I imagine it's very appealing to national health services; you put in a few hundred million from a large EU Framework Proposal grant, and end up with some useful drug available at the price of penicillin.

The problem is that everyone wants the potential of the jackpot; the impression I get hanging around at conferences (admittedly protein-structure-focussed conferences) is that there don't seem to be facilities around which will make fifty grams of some molecule and inject it into mice in return for cash rather than in return for IP rights.

There's the occasional vaguely promising project from research led by patient groups, though the compound described seemed much more likely to be a useful molecular-biology tool than anything that would ever make it to a patient.

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27. Hap on February 3, 2009 10:17 AM writes...

Mat: Grad students don't have free time - time taken to do hobbies and things is usually effectively added to the time needed to graduate. Considering that that's already 5-6 years for most organic chemistry graduate students (and probably more for biology grad students) and with industry and others complaining that there isn't enough content in the current PhD, that might be hard to swallow.

Grad students are unlikely to have a whole lot of money to fund research as a hobby, and if it's funded through grants, the granting agency or the university will want a piece of the pie (if not all of it) unless excluded by design.

I thought that part of the driver for open source for participants was the opportunity to make one's skills better and known to facilitate employment. Since drug development seems like a black box, the output can't easily be correlated with the input or the skills of particular people. (Open research might help individuals with networking to help them get other jobs.) In addition, it's beeen a topic of perversity to note the people primarily responsible for major drugs laid off recently - it seems clear that one is not rewarded for one efforts or output, so that may not be as career-enhancing as one would hope.

Tristan: Stuff driven by the service model would seem to require significant and constant maintenance costs (beyond exercise, etc. - the standard things) - that sort of model for health care seems to cost both money and time for the people doing it. You pay one way or another.

In addition, nothing (other than code for airliners or nuclear plants, maybe) requires the time and testing required for drugs, and because of the nature of the tests, there's no cheap way to do those tests - you have to test in animals and then in people (and in lots of both), because we don't know enough to predict biological behavior any other way. The cost of trials is a major part of the cost of drugs, and one that doesn't go away under an open source model. Also, cost of goods for open source is essentially zero (source is cheap to transmit with no physical cost in most cases) - for most drugs, that's not the case (for some, such as the thalidomide variants, it has little to do with drug costs, while for others such as the HIV entry inhibitor T-20, cost of goods is a major part of the cost of the drug).

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28. Cellbio on February 3, 2009 1:05 PM writes...

Milkshake, I tend to agree with you, especially the comment on starting with biology, cell or animal. I've actually done this and think it works, but management above me wanted to start with "target". Even though we could show a biological fingerprint much more selective than known drugs and target-based chemistries, without a molecular target, we got no support. I think in time this thinking will change.

The one thing I question, however, is how much tools will really impact our discovery, and the notion that low hanging fruit is still abundant. First, the concept of low hanging fruit should probably be left to the MBAs, because what does it really mean? In one sense, I think it could mean that drug discovery efforts of the past, reliant on biology, found a lot of the targets that are easy to drug, including GPCRs and NHRs that have small ligands and nice pockets. The corallary to this, is that our collections are biased to these types of molecules, and recent additionas like kinase inhibitor collections. So maybe our next burst of productivity is just around the corner as we crack some new targets with chemical space, but is that a reasonable expectation? I look forward to your thoughts.

The declining productivity of research leads me to think that we have moved through the easy pickings. Yes the structure of big pharma limits innovation and funding for newcos currently sucks, but I don't think these are the only limitations to productive drug discovery. The finite genome and prior success does pose limits. Perhaps a return to pharmacology driven research will help, but I also know how success in a therapeutic area, like rheumatoid arthritis and biologics, makes new efforts really tough.

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29. Jean-Claude Bradley on February 3, 2009 1:09 PM writes...

The contribution from graduate students does not have to come from "free" time if their PI is on board and they use their Open Source results in publications and their thesis. It does mean that you have to be selective in where you submit work for peer-review but it certainly can be done.

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30. Anonymous on February 3, 2009 6:48 PM writes...

Comparisons between drug discovery and development and software writing are absurd.

There is no argument, no debate, no spin that can be offered to make a comparison of the two not just idiotic, but pathetically and profoundly idiotic.

One is authorship of code by a group of people in the programming languages du jour. The other is about five orders of magnitude more complex in terms of knowledge, expertise, experience, creativity and insights into dozens or hundreds of complex domains.

It comes either from IT blowhards who have no idea what the scientists they supposedly serve actually do (hey - with all the right tools you could perform nuclear fission on your kitchen table, right?) or from blowhards who understand neither IT nor biomedicine.

I am really tired of the clueless and incompetent spouting sheer idiocy.

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31. Annon on February 4, 2009 9:40 AM writes...

Other than both must use the same patent and trade laws to protect innovation...

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32. hibob on February 6, 2009 1:38 AM writes...

to further MTK's comment to Tristan:
the last time I talked to someone who would know,
the total cost of employing a PhD chemist tended to be at least triple the salary. The overhead for a programmer (an office or cubicle, computer, benefits, 401K, etc) is there for a chemist as well - but then there is another SIX figures in consumption of materials, shared access to the equipment MTK mentioned, hazardous waste disposal, HVAC like you wouldn't believe ... and that's the cheap end of the process.

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33. doctorpat on February 8, 2009 6:41 PM writes...

"Comparisons between drug discovery and development and software writing are absurd."

I think that comparisons between drug discovery and development and chip design and development are pretty spot on. And you'll note that chip development hasn't been done in dorm rooms and garages since... ever.

On the other hand, I do think that drug development CAN be done much more cheaply and efficiently than it is at present. But it can't be done in the USA, or Europe.

You can set up a cheap development system, lots of animal and human subjects, heaps of in vivo testing (even in vivo screening), no ethics committees... you just have to choose the right city in China, or India, or even a Chinese/African joint project.

This will happen, and it will rip the current system to bits.

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34. Anonymous on February 9, 2009 12:41 AM writes...

Have all the simple diseases really been solved? I really haven't encountered anything for the common cold.

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35. mehdi on May 31, 2009 5:10 AM writes...

@anonymous have some placebo. their should be placebo for every diseases.

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36. partial agonist on May 31, 2009 4:00 PM writes...

#34- The common cold is common but certainly not simple and certainly not even one disease. The variation in cold virus is stunning and to "cure" each type of cold would require a cocktail of many different drugs or an exact genotyping of each patient's disease to determine which exact virus he/she has and which possible drug would work best. The problem is too complex to get off the ground- discovering 50 different drugs for 100 different virues, and for a short-term non-lethal disease.

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