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Open Source for Biotechnology
LarsWestergren writes "The Economist claims that Open Source is such a success for software development, the model should be used more often in areas such as biotechnology and bioinformatics. The similarity between open source and the academic process with their 'you share, I share' principles is shown by the human genome project. The paper argues that this process should be used for instance to developing medicines unburdened by patents, useful especially for third world countries or diseases that affect relatively few people, where medical corporations have previously thought that the cost of research have not been worth it."
Which is probably why something like this will never be allowed to happen now that people have seen how successful open source is.
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the way drugs are developed in a patent based profit world by big companies will mean that big companies will be slow on the uptake as they want to control their market share 100%
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the post is funny but the point is actually very interesting. Drug companies face huge legal risks from side-effects of medication (think thalidomide). How would open source medicine pay for these risks (somebody has to pay, even if it the patients who pay with their health)? The obvious answer is via a public health care system (like Canada's say) but there would likely have to be limits on the compensation allowable. But the basic idea of zero patent medicine research is excellent!
Having these types of projects being "open source" is a very good idea. The exchanged and access of information will not only allow more people to work on a project but for medicines it would in theory make them safer. Instead of having to take a drug companies word about a product you would have direct access to all the research and testing of said product from the beginning to the end.
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This open source idea for medicine and science would run into the same problem that open source software runs into. Greed.
People trying to get more money because they think they are entitled to it. Some examples would be Microsoft and SCO.
CEO Darl McBride who is at the helm of The SCO Group is leading the charge so to speak against open source software with claims to owning rights. Honestly most people realize this is a bid for them to be either bought out or to gain money from legal battles. This strategy is employed because it has the potentional to make money. SCO having not really made any innovations and in a steady decline over the years in terms of revenue and stock value has choosen this path. Now personally I think it was McBride's idea based on his track record with IKON Office Solutions. But then again the shady nature of SCO and it's parent company (explained here: http://www.forbes.com/2003/06/18/cz_dl_0618linux.
Microsoft on the other hand was sued due to a patent being violated by their Internet Explorer web browser. Reference here: http://news.com.com/Microsoft+appeals+Eolas+decis
Not to get into a rant about IP and software Patents but both of these cases show how money can be obtained through legal matters instead of the time honored method of working for it. No matter which way either case goes the problem is with old laws and ideas messing up the free (as in beer) trade of ideas and information.
Hopefully in the science field something like the above examples would not happen but there is always a chance. Big drug companies would not go quietly into the night if their development processes suddenly became public access and with more competition driving overall prices down. Big business loves to stay as BIG business.
Personally the idea behind "open source" science and medicine is very sound and will help many people in the long term. I just hope the process of it becoming free is less painful than the software industry.
Push harder towards Open Media/Content
Nice sentiments, but no one really expects reduced research costs, more competition in the bio-tech industry, or consumer scrutiny simply by "open sourcing" biotech info.
Rather, what the article points out is that there are niches - diseases which disproportionately affect the poor, that affect few people, or for which the patent for a drug has expired - which are ignored by drug companies. The costs of development and meeting regulation requirements would not be recovered in these situations. The article proposes to use an "open source" model to address these niches.
While the article does point out that a freer flow of information would help these situations, I think what the authors really want is the large army of (largely) volunteer brainpower that open source software has.
It would be a good idea if the source of test funding were not the company making the drug. Because that way the tests would be really independent and at least less likely to be influenced by the company which wants to sell the drug.
Maybe the health insurance would be the right place for funding tests. First, they currently do anyway, just indirectly (through paying for the drugs). Second, they have both a desire to have good drugs on the market (because better drugs means better health means less cost), and not to have bad drugs on the market (because bad drugs means no effect and/or bad side effects, which means extra cost for medication).
The Tao of math: The numbers you can count are not the real numbers.
Big Pharmas tend to develop hundreds of drugs per year. However, any drug that has a cost of production greater then 10% of its total cost is usually squashed due to the market. If those drugs were "given" in a "open source" manner, maybe some of those drugs would make it farther to help people. Who knows what drugs could have been developed and then squashed because it wouldnt make money?
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Um, I really don't think we want lots of people able to develop biological weapons in their basement. We already have enough problems with script kiddies making computer viruses, you'd think they'd learn.
This may be one of those technologies which creates a problem, the resolution of which is that the civilization making it gets knocked back to where it can no longer make the technology. (Classic examples from Science Fiction include certain general-purpose teleporters, as discussed in Niven's classic "On the Theory and Practice of Teleportation", and to a lesser degree the time viewer in Asimov's "The Dead Past".) I suppose that's one solution to the Fermi Paradox....
//Information does not want to be free; it wants to breed.
Now, obviously what I'm talking about is REALLY far down the road, but ultimately thats where I hope we arrive.
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Let's assume we do away with them though. Now let's compare two business models. In one, I spend hundreds of millions developing new drugs. Once I pass the very expensive FDA process, I sell my drugs at market rates. In the other, I sit on my ass and wait for someone else to develop drugs. Then I spend a million bucks reproducing the other guy's results and sell the same drugs at market rates.
Lets assume I spend 100's of millions developing a new car? get it? also, what you say doesn't reflect reality - most big patent money is spent on marketing not R&D.
second, the slavery analogy makes a good point. The property rights argument to justify patents is a bullshit argument. The incentive argument to justify patents is also a bullshit argument. The great wealth of the industry argument is also a bullshit argument. What else is there, other than I want to sit on my ass and collect royalties?
Keep in mind that if nobody spends the time, energy and cash to develop a drug, those people are going to die anyway.
Keep in mind that 1000's of researchers are forced to hold back sharing R&D and collaberating with other researchers for fear that one of them will get one up on them, get a patent, and lock everyone else out. Patnets cause this situation, and now you hawk patents as the solution - well no thanks.
Unless you want to present a viable alternative where drugs will be developed and put through FDA trials by somebody else, patents still seem to be the way to go.
And theres you're problem right there. You prove there isn't viable alternatives. You're the one who wants to coerce massive restrictions on what people can copy and immitate. You're the one who wishes to restrict everyone else. Any intellectual honesty would dictate a real justification for such impositions - not just bullshit talk about FDA approval, incentive and R&D that doesn't really match up with the real world.
It appears that open source is making its way into the data side of things... See the The RCSB Protein Data Bank , the human genome sequencing, etc.
But the bottom line is the following:
It costs (currently) about US$800 million to $1 billion to develop a drug. That is all of the initial trials, screening, 3 phase clinical trials, etc. This is typically a 10 year process-(there are some exceptions, but this is generally true).
The _reason_ why any company would invest this sort of money is so that they could have a monopoly on making it for 20 years. If everything were open sourced, and anyone could make anyone else's drug, why would companies put this much money into developing it? They would have no incentive to do so.
As someone else mentioned- this is not the sort of thing that you can just do in your basement. The company I work for makes a fancy robotic incubator to help you crystallize proteins. People want to do this so they can put them in an xray machine to get their structure, which can lead to possibly designing drugs that might interact with that protein. This machine costs about US$250,000. People need it because protein crystallography is hard- there's no way to predict under which conditions it will crystallize. You typically need to try 10,000-100,000 different conditions to get a reasonably sized crystal, that you can diffract and get the structure from. Some proteins _never_ crystallize.
This is way before you are even trying _anything_ in a biological screen, let alone animal trials, let alone phase 1, 2, and 3 (human) clinical trials.
If you do successfully crystallize the protein (and determine the structure, which is very straightforward once you have a good crystal), you can (and everyone does) submit it to the protein databank, and you can publish these conditions in a paper. So in this sense, lower level biotech is/becoming open source. But the higher level stuff requires a lot more thought and resources.
I'm not saying that there's no waste or greed in big pharma- Of course there is, like any other industry. Perhaps its higher than average, due to the large potential amount of money to be made.
My point is that the places that open source is successful- coding, which requires a $300 computer with an internet connection; wikipedia, which requires the same; there is a very low cost of entry to contribute. Even if companies and universities start open sourcing the lower level stuff more than it is now, Animal and human trials costs very large sums of money. Why would a company invest $10's of millions on one part of a trial if someone else could end up making (and selling) the drug?
I agree that cheap drugs would be great. But if its open source, and people start dying because of a side effect of the drug, who is liable? Not to mention who will fill out the FDA paperwork (there has to be $10's of millions invested just in complying with the paperwork. I've heard estimates that it is basically a medium sized room full of paper. And that's for 1 (one) drug.) -E
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The Economist is usually very good in its bioscience articles. This article is completely abyssmal - the person who wrote it has absolutely no understanding of how scientific research works. and that is not flamebait but the sad truth
First of all, we are a bio-informatics lab - all the software we produce is open source. This is not the exception but the rule.
The motivation behind our research is not profit and again, in academia that is the rule not the exception.
The article states that if aspirin were the cure for cancer - it would not be developed because there would be no profit. If that is true then it is a reflection, not of a flawed scientific research model but rather a flawed biotech/pharmaceutical model
Researchers like myself would be looking into it - because it would be INTERESTING and scientifically important regardless of whether it would be profitable.
Basic scientific research is done by publicly funded labs like ours. The results are freely communicated. Biotech companies use our results to make money (and rightly so) but in the end do very little basic research - because, as the article says, - it does not pay. However let us not get the two confused as our poor "science" writer did. The NIH funding model may not be perfect- for example there is probably too much emphasis on western diseases like cancer rather than third world problems like malaria - which sort of creeped into the article. And it is appalling that we have 10 versions of Viagra rather than cheaper generic chemotherapy alternatives but the blame for that does not lie with the lack of basic research but further down in the R and D food chain.
Sounds similar to the discredited [*cough -- Reagan *] idea of giving unencumbered federal research grants for universities to develop exploitable ideas for the common good?
Hmmm. This comment seems to be getting a lot of flack. I still stand by my arguments though.
Less barriers in biotech development would lead to faster production and more competition. Just think what the computer has done for the industry.
I did find this article as I was browsin' around. it describes the argument for and against Alexander fleming's decision not to patent penicillin. Enjoy.
May the Maths Be with you!