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"Open Source" Drug Development Company Launched
First time accepted submitter awjourn writes "During his years working in pharma R&D, Tomasz Sablinski was frustrated by the industry's need for secrecy and its utter inability to design patient-friendly drug trials. So he founded Transparency Life Sciences, a company that's developing three drugs based on input from patients and physicians, who log onto the company's site and voice their opinions about how drugs should be designed and tested."
Open sourcing things like education, arts, and soft/hardware is one thing. Messing with the pharmaceutical companies is entirely another.
I wish them luck.
Someone flopped a steamer in the gene pool.
But the importnat thing here is that this is the future. Not space elevators, moon colonies or condos on Mars, but home DNA testing and open source drugs. Pay attention. If you ignore these signs, you will be flattened by the future. Let go of your decades-old visions of a future that will never be.
Let's leave drug design to the chemists and biologists who are actually qualified to do such work. I want to drive over bridges designed by civil engineers, not drivers and city planners.
I could have really gone for something like this about 20 years ago.
An idea whose time as come. What a shame no one thought of it, or could make a credible beginning of it, sooner.
Open-source pharmaceuticals. It boggles the mind, but the overwhelming impression is of goodness, rectitude, unselfishness, and light.
If this works we should all thank God, or whomever we believe we owe.
Those are my principles, and if you don't like them... well, I have others.
PhRMA1 and BioTech just have too much control in that industry for them to get beyond producing the drugs. How are they going to crack the rigged industry to even get their product to patients? Or worse, past America's prescription writing puppet doctors?
Despite the claims on their website that "Transparency Life Sciences is the world’s first drug development company based on open innovation", the Open Source Drug Discovery group (based in India) has been doing this for over three years now, focusing on tuberculosis. I'm also aware of "Open Source Drug Discovery for Malaria".
When that's all done the answer will come back that it doesn't work at all, and you've just wasted $20M. So, you start all over again and burn through another $20M, and then do that another 5-10X until you get lucky.
Yep. It definitely won't work, because we know that things never change and there's no other possible way that things can be done. You probably didn't think Wikipedia was a good idea either.
It's obvious that the current system is flawed, and easily argued that the system is ineffective. We need other options.
You're unwilling to try new approaches, and you don't think anything will come of it. Fine, you're welcome to your opinion.
But we need change. We need it so much in so many different areas that we're willing to give up a tiny bit of safety to take a chance on something better. The chances of going bankrupt because of an idiot doctor, an inattentive nurse, or a heartless insurance company are so high that the risk/reward equation is heavily tipped in the other direction.
Doctors are allowed to try experimental treatments on their own patients. I see no reason why an open-source drug company couldn't partner with some meticulous and well-meaning doctors who are willing to try something different on the off-chance that it works out.
With full knowledge and consent of the patient, I don't see anything wrong with this.
And that's just off the top of my head. I'm sure there are other approaches to be taken...
But we won't know unless we try them.
By FAR the biggest need for drugs we have is for new antibiotics.
I'd be willing to support, with my own money, antibiotic development efforts. I'd support use of public money for antibiotic development.
In the USA, some 90,000 people die every year due to antibiotic resistant infections and that number is growing every year. In 1992, that number was 13,000.
To put this in perspective, we get 30x the deaths every year from antibiotic resistance than was inflicted on us by the 9/11 attacks. Every year.
Where is our war on antibiotic resistant bugs? Where are the billions spent to combat this 30x greater (actually higher, because we don't have 9/11-scale attacks every year) threat to our lives?
Best,
--PeterM
By FAR the biggest need for drugs we have is for new antibiotics.
Nope. That's just a treadmill-like arms race. What you want are bacteriophages.
I only post comments when someone on the internet is wrong.
"In Russia, mixed phage preparations may have a therapeutic efficacy of 50%. This equates to the complete cure of 50 of 100 patients with terminal antibiotic-resistant infection. The rate of only 50% is likely to be due to individual choices in admixtures and ineffective diagnosis of the causative agent of infection."
That is seriously amazing.
Space game using normal deck of cards: http://BattleCards.org
While developing new ones would certainly be nice, we should really be going after the low-hanging fruit and cracking down, hard, on the present overuse in veterinary applications. Unpopular among the direct beneficiaries, certainly; but cheap per-capita and a guaranteed way of improving the efficacy of the drugs we already have, not just the ones we hope to develop...
By FAR the biggest need for drugs we have is for new antibiotics.
Err, no.
Where is our war on antibiotic resistant bugs?
The problem is we've thrown antibiotics at everything, in excess, for far too long. Why are there so many antibiotic resistant bugs? Because we've used antibiotics so much that it's been easy for bugs to adapt. We abused them.
Back on topic...this guy explains why medicines are so expensive. Producing a little pill isn't that hard - researching, developing, and failing many more times than you succeed, and taking the immense risk in today's litigious climate, is insane.
Starting your own computer consulting business is highly risky (as is starting any business), and it's certainly something that's been discussed on these pages many times, so readers should be familiar with just how horribly expensive and stressful it is. Now multiply that by some dreadfully huge number to take into account all the factors listed in that post I linked to. There's nothing easy or trivial about it.
And this guy points out why most /. posters won't get that, ever.
Any "editor" who lets basic things slip through like its vs. it's must immediately be executed. Preferably they will have their nipples cut off and then toenails and fingernails ripped out so they bleed out. There are probably other mistakes in the summary but I'm just focusing on the its vs. it's aspect right now.
But I've got to admit, if there's one movement which needs drugs..
Antibiotic resistance is mainly due to the misuse and overuse of antibiotics.
Over half the antibiotics in use are used in animal feeds to help fatten animals quicker, not to treat sick animals.
Please, God, no. The problem is that people use way, WAY too many antibiotics already and they're used even for such things as common cold! And hell, common cold is a virus infection, antibiotics do not kill viruses so it's not only completely useless, it literally ENCOURAGES the growth of antibiotic-resistant bacteria.
We need less antibiotics, we need doctors who do not prescribe antibiotics as a cure-all solution and we need people to understand why it is such a bad idea to just pump more and more of those in yourself, all those around you, and even animals! Since you seem to have excess money use it to instead educate doctors -- and yourself, mate! -- about the dangers of overusing antibiotics.
You start out saying "...and it is utter inability to design patent-friendly drug trials," but then you don't finish the sentence. So, it is utter inability to design patent-friendly drug trials ...that... what? Please finish your sentences.
- Tweaking the ears of the grammatically challenged since 2002.
What could possibly go wrong?!
The game.
If I had mod points, Interesting would be my first click
But I have to wonder why people get infections in the first place. Was it that back in 1992 there were less people seeking medical treatment? No. But plausible. Could it be that healthcare is now run more like a fast food joint where patients are in and out in no time in order to increase bed turnover and, in turn, profit for the hospitals and medical groups? Absolutely.
The game.
It would be great to see what could be done with tropical diseases - worms and some bacterial drugs.
A community can see many positives - schools get more students, people get back to work and long term the community grows.
No need for refrigeration or many follow ups. The drugs are cheap and well known. A community can be saved from blindness, long term disability and early death.
Over time the water supply can be improved. So I feel it would be great to see more drugs going after worms and other dirty water bugs.
Domestic spying is now "Benign Information Gathering"
We need less antibiotics, we need doctors who do not prescribe antibiotics as a cure-all solution and we need people to understand why it is such a bad idea to just pump more and more of those in yourself, all those around you, and even animals!
This is true. It is also true that we have antibiotic-resistant strains of serious diseases killing people right now, and we need ways to treat these diseases. What are you going to tell someone who's dying of a MRSA infection -- "Sorry, too many farmers give antibiotic-laced feed to their dairy cattle, and we're not going to treat you because we don't want to encourage the growth of more resistant strains, so go ahead and die"?
Many, many of the things that kill people could be prevented by better practices. Almost all lung cancers, and many cases of heart disease, could be prevented if nobody smoked, or even if smokers smoked much less. Most of the remaining cases of heart disease could be prevented by better diet and more exercise. Most types of liver disease would be much less prevalent if nobody drank, or at least nobody drank to excess. MVA trauma could be almost eliminated if people drove better; for those few accidents which are truly nobody's fault, consistent seatbelt usage would take care of most of the rest. AIDS would very nearly go away if everybody wore condoms when having sex with anyone they weren't 100% sure was clean, and no IV drug users shared needles. Etc. But the reality is that people are dying of all of these things, right now, and you have to be a real shithead to say to them, "Too bad, you shouldn't have eaten all those Big Macs," when they're clutching their chests and falling over. And you'd have to be even more of a shithead to write off people suffering from antibiotic-resistant bacterial infections, because -- unlike most of the other diseases I mentioned above -- it's not even a matter of personal choice of behavior on the victims' part.
In a perfect world, medicine wouldn't exist. Anyone who's spent any time in patient care knows we don't live in that world. Medicine is about dealing with the ways in which the world is imperfect, and that means dealing with the way it actually is, not the way it ought to be.
The correlation between ignorance of statistics and using "correlation is not causation" as an argument is close to 1.
PeterM, could you supply references for the statistics and other details you mention? I'm interested, as it relates to our area of research, but I haven't come across it before quite the way you describe it.
Actually, I don't care whether it's new antibiotics or phages or chemicals which disable bugs from being able to resist antibiotics, I do, however, want something that works, unlike antibiotics nowadays.
--PM
Right you are, sir, but still the problem remains that the current set of antibiotics has been largely defeated by our germ adversaries.
We need to do both, and make sure the new ones aren't defeated in the same way as the old ones.
In addition to what you said, really good sanitation in hospitals would cut the death rate down a great deal, too.
--PM
Thank you, you've rebutted very effectively. We need new antibiotics, because the ones we have don't work anymore, AND we need to protect the new ones by not abusing them!
--PM
We still need NEW antibiotics, because as you've pointed out, we've destroyed the effectiveness of the EXISTING ones by ABUSING them.
How about we get new antibiotics, AND we don't abuse them?
So things like drug-resistant tuberculosis aren't a death sentence?
--PM
I hope you can see that we need NEW antibiotics (or bacteriophages or whatever) because as you've pointed out, we've destroyed the effectiveness of the EXISTING ones by ABUSING them.
How about we get new antibiotics, AND we don't abuse them?
So things like drug-resistant tuberculosis aren't a death sentence?
--PM
Using phages as treatment would be awesome! My main concern about the old-school antibiotics is their lack of specificity and with the rise of metabiomics, it is getting more and more apparent that the complex flora of bacteria in our gut regulates a lot of our physiology and psychology (in fact, the gut is one of the most neuron-dense organs sometimes called the "second brain"). Secondly, phages are open for genetic design so we could further improfe their efficiency, specificity and safety as treatment. I really wish that some real effort would be put into this kind of drug development. There are interesting correlations between excessive antibiotics use (in some regions the prescribe antibiotics even against stuff not caused by bacteria, which is just crazy) and a wide range of health problems.
They need to be creative and go around all of the FDA rules. If I had to do something like that I'd tell the potential customers that they couldn't buy the new drugs unless they were part owners of the company, so they would have to buy stock in the company, and as partial owners it could be that they are 'part of the team that develops the drugs' and thus they are just participating in quality assurance or something of that kind.
FDA is a major contributor to the cost of drugs/technologies and gate-keeper protecting the monopolies and keeping the competitors off the market.
You can't handle the truth.
Sorry for this digression, but is there any special reason pharma companies use rats instread of mice in tests? I have more trouble with them using rats than mice, as rats are in a different league when it comes to intelligence and especially "social intelligence" and empathic behavior than mice. Rats are clever creatures fully capable of feeling pain (including the pain of other rats in distress).
If they are any good, I suspect the Trust may fund them - you know, the wonderful organisation that funded the project to decode the human genome to prevent Craig Venter from creating a capitalist monopoly on your DNA?
From scarped cliff or quarried stone she cries "A thousand types are gone, I care for nothing, no not one."
Because no matter how much you say "let's just not abuse them," they will be abused. We don't even need new ones, just wait for old ones to become effective again. You can't expect bacteria to be permanently resistant to all antibiotics, that would be incredibly wasteful. Eventually via natural selection they will shed their resistance of older antibiotics that are no longer in use and we can use them again.
Only problem is other bacteria still having resistance and passing it across quickly.
There's a name for those: other antibiotics.
Well, there's others, like nitric acid and fluorine. They aren't without side effects, however.
Confucius say, "Find worm in apple - bad. Find half a worm - worse."
Developing a new drug takes hundreds of millions of dollars. Suppose you spend that and you some up with a completely new class of antibiotics. You've now got two problems. Firstly, for 99.9% of the infections out there the existing antibiotics work very well and are now generic, meaning low cost. Quite apart from that, no clinician is going to prescribe your new "last resort" antibiotic for someone coming in with a sniffle: you keep it in reserve for the people with vancomycin-resistant MRSA. The combination of these two means that your total market is maybe a couple of thousand people per year. You've just burnt>US$500M on development costs, so how are you going to get that money back? The solution to the antibiotic problem is to quit misusing the ones that we already have. Nobody's going to develop new ones any time soon.
Clinical trials are expensive, complicated, and the success rate of producing new medicines is extremely low. The National Cancer Institute says it takes on average 769 steps, 36 approvals, and an average of 2.5 years in order to just get a study going. Transparency Life Sciences approach appears to be to leverage open source principles to facilitate pre-study planning in order to design better protocols. This may help to have a higher success rate on clinical trials--at least if your trial doesn't go the way you'd like, you'll know it'll be less likely to do with a bad protocol design.
After planning is over, then there's the very non-trivial matter of collecting the data. Open source is making inroads here too. Here's an article (written by yours truly) called "Overcoming Obstacles to Successful Clinical Trials through Open Source:"
http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=743711.
It talks about how open source can be used to lower the costs and enhance the quality and productivity of the operational aspects of clinical trials. One notable example of an open source project trying to do this is OpenClinica: http://www.openclinica.org/.
The answer is that they do not use rats instead of mice. They use rats as well as mice (and guinea pigs, hamsters, dogs, pigs, monkeys and other animals). It all depends on what they are studying and which animal is a better analog for humans for that particular study (or, in early stages, provides the easiest/cheapest way to identify the results being tested for).
The truth is that all men having power ought to be mistrusted. James Madison
What you say is great if you're not one of the 90,000 who die per year. And you're right about the payback--antibiotics don't make money, which is why I advocate public support for the development of new ones. Payback is the issue that keeps drug companies from falling all over themselves to meet this need.
THEN, you carefully restrict how the new ones get used so they stay effective as long as possible.
The 500M development cost works out to $500 or so per life saved over 10 years. Maybe it's worth it???? Not to mention worldwide application, the cost gets a LOT LESS per life saved.
Please compare this with the benefits of our trillion dollar wars.
Now, how about some new antibiotics, please?
--PM
Not really, there are drugs which won't kill bugs themselves, won't hurt them at all, but simply disable them from being able to resist antibiotics.
You could never give one of these WITHOUT an antibiotic partner and expect it to do anything.
It's just another step in the arms race, though.
--PM
You can use my drug as an ingredient to newer drugs, as long as you keep my recipe open, etc....
Uh, Linux geek since 1999.
Also an arms race.
The only "open source" part is voting on what drug to trial. Mix in some stuff about telemedicine and vastly cheaper trials and the corrupt, run by the man current system....
Trial design isn't that hard, and clinical measures aren't that expensive. Imaging, and image analysis is, but imaging also usually vastly reduces the number of subjects, or time, you need.
A kickstarter style approach to funding trials for unpatentable drugs is a much more interesting idea.
We need new antibiotics, because the ones we have don't work anymore, AND we need to protect the new ones by not abusing them!
Absolutely, and I hope we can avoid abusing newer antibiotics as we have the old ones. Right now, most of the newer ones are insanely expensive and come with nasty side effects; these are not good things, of course, but they do help hold the abuse down. So far.
The correlation between ignorance of statistics and using "correlation is not causation" as an argument is close to 1.