New Startup Hopes to Push Open Source Pharmaceuticals 101
waderoush writes "Nothing like the open source computing movement has ever caught fire in biology or pharmaceuticals, where intellectual property is king. But drawing inspiration from the people who make Linux software, and the social networking success of Facebook, Merck's cancer research leader has nailed down $5 million to launch a nonprofit biology platform called Sage, which aims to make it easier for researchers around the world to pool their data to make better drugs. 'We see this becoming like the Google of biological science. It will be such an informative platform, you won't be able to make decisions without it,' says Merck's Eric Schadt, a co-founder of Sage. He adds: 'We want this to be like the Internet. Nobody owns it.'"
The big OPEN SOURCE project that I see iseducation (Score:3, Interesting)
I don't know how to start this though. I considered being a jerk and just linking everyone's educational videos on a site that is just a giant index to start... But I don't want people complaining that it is their Intellectual property. The task is too big for me to tackle alone because even though you only have to make a years worth of videos one time for a subject, it still takes a lot of time to do this. To make an online education school with videos would take a lot of work, but I think it'd be worth it for society. Anyone have ideas on how to start something like this?
Re:Authentication (Score:3, Interesting)
There was just recently a case in which the FDA quit accepting applications for approvals from a company. That company was found to be tainting studies, and was the only source of data for the drugs they wanted approved. See bio-medicine.org [bio-medicine.org]'s coverage of that news item.
If you have multiple sources and most of them are reputable, are you better or worse off than having one source with a unique incentive to put their own drug in the best possible light?
Re:Drug Testing (Score:5, Interesting)
Drug research isn't actually all that expensive (as in generating concepts). What is expensive is drug development - which is working a concept into a drug candidate and then putting it through trials.
I suspect that what will happen is that drug companies will look at the breakthroughs in these open consortiums and then develop candidates and patent them and run them through trials.
Example - the "open source" consortium discovers that inhibiting enzyme A cures cancer. Now, you can't patent the idea of inhibiting enzyme A. However, you can patent molecule 123 as an inhibitor of enzyme A. Somebody else could of course come up with molecule 456 which does the same thing but is a different molecule entirely. That's what we call a me-too drug and it is the reason why people with drug allergies don't die of diseases (they can take a me-too drug instead), and the reason for marginal improvements in classes over time (maybe molecue 456 is slightly better than 123).
However, once the company proves 123 is safe, they own the market until soembody else comes out with another drug. 123 is after all patent protected.
Consumers still win because maybe 456 comes along a year later and prices drop as they compete.
The issue at big drug companies is that they're having trouble coming up with breakthrough ideas for new drugs. The market doesn't need another statin that works 3% better than the 14 that are already on the market. However, something novel would certainly be both profitable and beneficial to the public. So, drug companies are trying to fund more novel R&D. Once some concepts worth developing come out the big pharma companies are experts at running molecules through the process, and after a few hundred million dollars spent getting something on the market.
This is also smart as the expensive part of drug development is the development part. You're not going to find poorly-funded researchers contributing much to that part of the puzzle. However, the blue sky research component needs ingenuity more than money - and that is what things like this are good at.
It is an interesting concept - I wonder how it will work out...
Re:Not "open source pharmaceuticals" (Score:3, Interesting)
HIPAA (not "HIPPA") doesn't have to be a barrier to sharing research data -- take a look at the U. of Pittsburgh's Honest Broker System [nih.gov] for a very nicely put-together, largely decentralized method of moving data around while staying well within privacy guidelines. Financial interests are a much bigger obstacle to the free exchange of knowledge than are even the strictest regulations.
Not about making drugs, it's about sharing data (Score:2, Interesting)
What's interesting about this (I think) is that they're trying to open up research data that usually gets discarded or hidden. They're not necessarily talking about clinical trials of drugs in the FDA approval process. There's lots to be learned from the effects of drugs on various cell or tissue types at various stages of disease or age or any other variable of interest.
If a research group is studying the effects of compound A on some disease (atherosclerosis, for example), they might use a microarray study the effects of the changes in gene expression on endothelium. Maybe that compound turns out to be useless in this context, but they have data that might be meaningful on some other pathway like cell adhesion which is often implicated in cancer. That data would have been tossed because it was uninteresting to original question but could be meaningful to someone looking at something else.
But now you have two bits of information. Compound A doesn't effect atherosclerosis but it effects cell adhesion. And that tells us something about the wiring of the cell type in question. In their view, the interaction of genes forms a network and hitting one part of the network has an effect on cell adhesion but not atherosclerosis. So those pathways must not be directly linked. But compound A hits something in the cell adhesion subnetwork.
With a lot of little stories like this, you could build yourself a detailed idea of how different aspects of cellular machinery interact. And what targets are good to hit and what aren't.
Re:Oh, please. (Score:4, Interesting)
Well, we will never know how truly hard and expensive medicine is, since there's enough regulation in the industry to make new entry very difficult.
Of course drug research is expensive when you need to a) make sure your research is patented enough so that you have the exclusive rights to anything and everything that you research and b) make sure that you're complying with the expensive government regulations. Regulations that are pennies for a mega-corp but prohibitively expensive for a new start-up.
It's also common procedure for any big corporation to pay top dollar for retired politicians to lobby government in their in their favour. To regulate in ways that make it profitable for the existing corporations at the expense of everyone else.
Human history is full of small groups of researchers, not connected with huge pharmaceutical companies, who made important discoveries in medicine. From penicillin to the polio vaccine.
Existing non-Patented Drugs (Score:5, Interesting)
I wish they would invest more time in making available drugs that have already had their patent expired. I am not talking about stuff that expired yesterday, I am talking about stuff that been out for years but the market is too small for a large company to invest in it.
I forgot the name of the drug, but it was a cheap drug that served a small market, but it very vital. It was being produced cheaply for years from one factory that served the whole market. Somebody bought it and then jacked up the price by 100 fold. Why? Because no one was going to bother with drug that had such a small market share, but it was critical the people who depend on the drug.
Someone tell me what the drug is? I believe there was an article in the NY Times a few years ago about it.
Re:OTC... (Score:3, Interesting)
Very Simple,
If antibiotics are over-the-counter, then they will be over-used, and/or misused in ways that lead to more antibiotic resistant strains of bacteria (e.g. penicillin-resistant gonorrhea, or MRSA [wikipedia.org]). Shelf life is another concern. Several common prescription medicines not only become ineffective as they age, but eventually become toxic. OTC interactions with prescription drugs are a common problem that would spread as more medicines are made OTC. Too many people take dosage and usage directions for prescription and OTC drugs too lightly as it is. Making more drugs OTC will only make this problem worse.
Re:I get the joke (Score:4, Interesting)
Noob mistake and karma burn. I forgot to post as plain text. My apologies.
This turned into a book. Sorry. This post lacks citations and specifics for reasons that should become clear.
A full-fledged fully-stocked bioengineering lab isn't really necessary. A high school chemistry lab would be overkill for most of it. Most plant extractions can be done with nothing more than an acid (hydrochloric preferred), a base (sodium hydroxide preferred), distilled water, a separatory funnel and a set of mason jars. Some extractions might further require a bunsen burner, while others might require an alternate solvent such as ethyl alchohol. A blender and a freezer is helpful.
Anyone that has passed a lab course should be able to extract aspirin (and a bunch of other chemicals) from willow bark in their kitchen. Purifying it down to a single active ingredient is much more complex, but that step is often unnecessary. Provided the plant has no materials with higher toxicity than the sought-after chemical, a simple extraction can be done relatively easily. It takes at least a week (without good equipment), usually more like 4 weeks, so this isn't a 'pick that from the garden and extract' process.
Actually purifying these extracts is generally either a crystallization or gravity separation process (or both), both of which can be greatly enhanced by the appropriate solvent or by the use of a centrifuge. There are some plants that contain other, unwanted toxic materials with similar physical and chemical properties. This is where the difficulty level starts to ramp up. If you know what you are doing, you can cause either the desireable or the undesireable substance in solution to react and precipitate out, then continue the refinement as normal. All that is required here is access to the appropriate reagents and an understanding of which chemicals to use (in addition to lab process familiarity).
A person could become competent at all of these processes given a few hours' training and a guidebook with specific instructions. It would be no more difficult than passing a Red Cross first aid test. They would not be chemists, but they would be able to make useful medicinal plant extracts. Of course, this would never happen. The same skills allow access to a number of interesting compounds which are illegal, where the source plant is not (due to proliferation).