"Open Source" Drug Development Company Launched 140
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."
Careful... (Score:4, Insightful)
Open sourcing things like education, arts, and soft/hardware is one thing. Messing with the pharmaceutical companies is entirely another.
I wish them luck.
Re:Careful... (Score:5, Insightful)
Nobody is going to sue them. They'll do just fine when it is just a few low-paid workers working on concepts - that is the cheap part and it is done by all kinds of start-ups/etc.
Eventually they'll get all excited that they have the next cure for cancer and there will be newspaper articles about how it kills cancer cells in a test tube. That probably happens every other week in some lab somewhere across the country. The big question is - does it work in people, and does it have some nasty side-effect? This is a relatively simple question to answer - you just need to kill a few hundred lab rats first (hmm, suddenly operation "Transparency" is either keeping very quiet about this or they're going to be protested into oblivion). Then, if the lab rats do reasonably well you start doing clinical trials.
How do clinical trials work? Simply, you throw a lot of money at a lot of doctors to convince them to take the time to suggest to their patients that the drug might help them. Some doctors will follow the protocol and collect good data. Other doctors will try to get anybody then can find to take the drug whether or not they're a good candidate per the protocol and collect extra fees, and they'll add lots of noise to your data. After you repeat this a few thousand times you'll have run through tens of millions of dollars - mostly spent on getting doctors to participate (most of the patients don't get much of anything), and to some extent on clinical testing (though you don't have to pay lab techs nearly as much as independent doctors.
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. That is assuming somebody keeps dishing out that kind of cash for you to operate. Once you get through all that you can go ahead and put your drug on the market. At that point anybody who gets the sniffles when they take it will probably try to sue you, but assuming you're charging $5/pill you can probably still make a good profit. Of course, then everybody calls you a sellout and talks about how cheap drugs are to make and that some Indian company can do it for 5 cents a pill. Naturally the Indian company didn't fork out $20M 10X over 5-7 years trying to get it right, so its expense base is way lower. Or, you can sell it cheap if the people who forked over the original $200M didn't care to make a profit. More power to them if they can find that kind of money - I think it is probably the future of drug development (though likely with governments paying the bill - right now they almost never pay for trials since they aren't really all that innovative).
Lots of companies discover drugs - including some start-ups that have grown into major companies in the last 15 years. The reason nobody has come out with a brand new medication that costs the same as Tylenol isn't because there is some grand conspiracy. The problem is that the success rate is low, and the cost of clinical trials is very high.
I don't really see the comparison with open source software. It sounds like they're taking suggestions, which is nice, but it isn't like anybody can just whip up some pills in their garage, test them out on homeless people, and report in if they work OK.
Re:Careful... (Score:5, Insightful)
Nobody is going to sue them.
Suing will be the least of their problems.
They'll be subject to huge FUD and smear campaigns from the get go, have supply and distribution channels blocked, approvals refused and so on ad nauseum.
It's a shame, but efforts like this to open up our society scare the hell out of governemnt and business interests.
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I wish I could say you weren't so damn on the money with that...
Truth is an open platform is prone to encourage all kinds of unfair competition against them from the
established med companies, should they get traction.
On another hand, I can understand open sourced research. But on a manufacturing and market
level? Sounds much more difficult...
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If it's truly "open" as they say, it won't stop it. There's plenty of things people believe in today that won't die out, and plenty of stuff that doctors keep insisting won't work, and do.
You know, alternative medicine (acupuncture, mostly), h
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"Do you know what they call alternative medicines that have been proved to work? Medicine."
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Are you free, Mrs Slocombe?
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Ever since Bill Gates got involved in philanthropy, I've believed he should only focus on "big issues" like this one. He (or rather, his money + Warrent Buffet's money) is the only one with the clout and money to pull something revolutionary like this off. Unfortunately, he's too busy putting band-aids on a leaky dam just like everyone else.
Another Malthusian Failure (Score:5, Insightful)
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.
Re:Another Malthusian Failure (Score:4, Insightful)
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
There's "no other possible way that things can be done" because most of them are illegal. Unless you want to get rid of the only part of the FDA's mandate it can actually carry out with any efficacy.
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They ARE pretty effective at kickbacks and dirty tricks, but it only SEEMS to be part of their mandate!
Perhaps it's time to scrap the agency and start over. We do need a regulatory body for drugs, but the FDA isn't it.
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You're unwilling to try new approaches, and you don't think anything will come of it. Fine, you're welcome to your opinion.
Companies have been trying new approaches all the time - some work better, and some work worse. However, the problem also keeps getting harder, as new drugs have to be better than existing ones to be worthwhile. Often the new ideas are tried in startups, and some have been successful. However, in the end nobody has made such a huge change in how the game is played that people have noticed, which is why you're looking at this company like they're doing something earth-shaking. Even TFA points out that th
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Doctors are allowed to try experimental treatments on their own patients.
Only if those treatments have already been approved by the FDA for use for something else, or are part of an FDA approved testing regimen.
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Speaking of alternative methods.
Lets say I go to my family doctor, have my DNA sequenced in one of those fancy new cheap sequencers and added to my medical records. Then I agree to have my records, drugs I have taken and interactions, other conditions I have added to a database anonymously.
Then these open source drug companies can take a look at this database, combined with DNA from folks in clinical trials and do some data mining on possible chemistry avenues to explore.
You do the same thing with folks tak
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Pharma companies already do SNP analysis on their clinical trial volunteers whenever they can.
The only thing that the DNA helps with is understanding diseases to come up with treatment mechanisms. That is very important, but it isn't the part that makes drugs expensive. If you have a good mechanism of treatment then it is almost inevitable that you will be able to make a drug, but it is also inevitable that you'll blow through maybe $100M or so in the process.
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I think he meant "The prototype drug won't work". Sadely(sic) making a new drug (that isn't just a generic copy of another) is like coding a new software with java while you only know C#
I think you mean is like coding assembly for a new architecture from an existing assembly program.
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Sadely making a new drug (that isn't just a generic copy of another) is like coding a new software with java while you only know C#.
As principally a Java programmer, I've only done one C# project, It ran quietly for more than five years, even was moved to a new machine without issue by someone who contacted me once with some basic questions because he saw my name associated with it. I'm sorry, your point was what exactly?
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I think it was something to do with anecdotal evidence, and the assholes who think it proves anything.
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Re:Careful... (Score:5, Insightful)
GlaxoSmithKline Pharmaceuticals makes over $8 billion dollars a year on 1 drug alone... Advair.
It's $450 for a 30day supply.
Their patent has run out, but they either sue or bribe the FDA into scuttling any efforts of anyone that attempts to make a generic.
Of course, there's a generic in India that sells for $30/month
I literally can not breath without taking this.
So, I agree... they should make a profit. I don't even want the drug to be "cheap"
But is $8 billion a year enough profit? Would it hurt them if it were only... I dunno... 2 Billion?
And I don't want it for free... but $450? Really? Could be do it for $100? I don't need the fancy box it comes in... or to hear all those ads... the dispenser is right out of startrek. Dumb it down a bit. I just want to be able to afford to breath again.
You're already Rich as fuck GlaxoSmithKline. You've got swimming pools full of money. Please... price your drug back down out of the "Holy fucking shit" range so I can breath again... or at least let someone else do it for you.
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"Or, you can sell it cheap if the people who forked over the original $200M didn't care to make a profit." GlaxoSmithKline Pharmaceuticals makes over $8 billion dollars a year on 1 drug alone... Advair. It's $450 for a 30day supply. Their patent has run out, but they either sue or bribe the FDA into scuttling any efforts of anyone that attempts to make a generic. Of course, there's a generic in India that sells for $30/month I literally can not breath without taking this. So, I agree... they should make a profit. I don't even want the drug to be "cheap" But is $8 billion a year enough profit? Would it hurt them if it were only... I dunno... 2 Billion? And I don't want it for free... but $450? Really? Could be do it for $100? I don't need the fancy box it comes in... or to hear all those ads... the dispenser is right out of startrek. Dumb it down a bit. I just want to be able to afford to breath again. You're already Rich as fuck GlaxoSmithKline. You've got swimming pools full of money. Please... price your drug back down out of the "Holy fucking shit" range so I can breath again... or at least let someone else do it for you.
It costs billions to get a drug to market: http://pipeline.corante.com/archives/2012/02/10/the_terrifying_cost_of_a_new_drug.php [corante.com]
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the current drug development systems are horribly inefficient , they resemble what programmers would conceder "brute force" methods, try almost everything you can see what has an effect and go from there. At each step were you might want to improve the drug only use understanding based approaches only if all else fails. This used to work much better, the diseases that we where trying to treat where simpler and our understanding worse, but as modern technology advances this methodology becomes more wastefu
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the current drug development systems are horribly inefficient , they resemble what programmers would conceder "brute force" methods, try almost everything you can see what has an effect and go from there. At each step were you might want to improve the drug only use understanding based approaches only if all else fails. This used to work much better, the diseases that we where trying to treat where simpler and our understanding worse, but as modern technology advances this methodology becomes more wastefull. Part of the problem is that understanding how a drug works gives your rivals a way of making alternatives so is unattractive unless you have no other option, but there is a lot of inertia involved as well. This is not their only problem but it is a massive issue and they should be able to save a lot of time and money by starting from understanding instead.
Human biology is a lot more complex than a computer, and failure of a drug in that system is somewhat less socially and legally tolerated than a computer crashing. Perhaps you, Dr. AC, with your apparent singular knowledge of the problem, could enlighten the thousands of pharmaceutical researchers as to what - exactly - they are doing wrong? I am sure they are ready to drop their Erlenmeyer flasks and instead just "understand".
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Development costs on failed drugs would be a LOT lower if they would terminate failures in phase 1 or phase 2 rather than sweeping the negative data under the rug. Liability would be lower if they didn't continue the sweeping in phase 3 trials. Their problem isn't the complexity of biology, their problem is 'go fever'.
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a seminar on drug development by someone in management in of one of the major companies.
There is your problem in a nutshell.
You keep talking about "better understanding" as if it were an alien concept. Maybe it is to that managment dweeb. When you do get your doctorate and go for interviews, you will see whole buildings of people searching for that better understanding.
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It costs billions to get a drug to market
There are some things I don't get in the interaction between social security and private pharma. I live in France with what americans call 'socialized medicine'. It works well but of course it means that the cost of most drugs is eventually paid by Social Security though taxes. So it's in the advantage of Social Security to have this price as low as possible and since they are the ONLY customer (it's not like you can pay for drugs out of your own pocket even if you wanted to) they should be able to bargain
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OK, let's see if I get this straight: Most new molecules are discovered by public research in (public) labs and universities, and then 'given' to big pharma for testing and development
Citation needed. As far as I am aware (and I work at a pharmaceutical company), pharmaceutical companies pend quite a bit of time developing and testing new compounds to see if they are more efficient/safe than known compounds (my job is to provide IT support to the scientists who do this research).
Testing indeed costs a large amount of money but needs the help of (public) doctors
Please define "(public) doctors", in the U.S. most doctors either work in private practice or for a large hospital/medical corporation.
Manufacturing is often cheap but sometimes priced absurdly high (like the recent example of an appetite booster that went from 1$/dose to $1000/dose when exclusivity was given to some big pharma)
Yes that last is true, however, in almost every case, the pharmaceutical com
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No, Pharmaceutical companies spend quite a bit of time developing and testing new compounds to see if they can extend their patents further. The makers of the standard asthma drug albuterol invented a new inhaler that did not use CFCs. They patented it and then lobbied congress to ban the old delivery system that had been out of patent for years under the guise t
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Sounds like a job for the FDA. We don't make parolees their own parole officers for a reason.
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It costs billions to get a drug to market:
And yet they still have one of the highest profit margins of any industry.
Profit = income - costs
So how terrifying can those costs really be if you're still showering in money after paying them?
Oh and let's not forget that their biggest cost is not R&D but marketing. I wonder why you don't see any articles about "The Terrifying Cost of Marketing!" to justify the prices of pharmaceuticals? Just kidding, it's because that would obviously be stupid.
Yet complaining about the cost of getting a drug to mar
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And they have made billions and billions (and billions and billions and billions) year after year on Advair. OP is asking if they might just do it for 'only' billions and billions a year now.
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And yet they still reap billions and billions a year in profits...
Read through the comments on that article and you'll find several issues with its logic.
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GlaxoSmithKline Pharmaceuticals makes over $8 billion dollars a year on 1 drug alone... Advair. It's $450 for a 30day supply.
From this, it's REALLY obvious that they're simply charging whatever they can get away with. I live in Canada, and I pay $170, including the dispensing fee, for a 120-dose Advair 25/250 inhaler. (I don't like the disk). I don't have a benefits plan, so the price I pay is the full shot, yet it's well under half of what you pay. Raping and pillaging, anyone? Is it any wonder that Big Pharma is universally despised?
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"Or, you can sell it cheap if the people who forked over the original $200M didn't care to make a profit."
GlaxoSmithKline Pharmaceuticals makes over $8 billion dollars a year on 1 drug alone... Advair.
It's $450 for a 30day supply.
Their patent has run out, but they either sue or bribe the FDA into scuttling any efforts of anyone that attempts to make a generic.
I'd be the first to agree that things like this need to be reformed. I once heard a talk by some guy saying more companies should try to do what was done with Advair and nearly fell off my chair - that is just pure greed.
I'm fine with companies making a healthy profit since they sunk the costs, until the patent runs out. Once your 17 years or whatever are up, and maybe another year if you toss a bones to the little kids, then you should have to move on. If I had the power to do so I'd put an end to these
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It's a terrible solution to the problem of pharma companies profiting from the suffering of people. Switch to the universal healthcare option and o
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no more incentive to create fifty pills for some stupid thing like erectile dysfunction instead of a harmful disease
As far as I am aware, all of the drugs used to treat erectile dysfunction were originally developed for other purposes. The original work on these drugs (they are all relatively closely related compounds) was looking for a treatment for high blood pressure and heart disease. It was only after researchers working for Pfizer discovered that Sildenafil (Viagra) induced penile erection in test subjects (when they were testing it for effectivieness in treating angina pectoris), that the other drugs were tested f
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Switch to the universal healthcare option and on top of that start funding drug development.
Yup. The societal problem with pharma companies isn't that drugs are expensive - that is just the nature of the beast (we can argue over whether they should be $4/pill or $5/pill, but they aren't going to be 10 cents if costs are accounted for). The problem is who has to bear these costs.
If you had government fund more development and hold the patent rights, then you could have 10 cent pills, and that's before you get into universal healthcare (which is probably still necessary since while they're everybo
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Eventually they'll get all excited that they have the next cure for cancer and there will be newspaper articles about how it kills cancer cells in a test tube. That probably happens every other week in some lab somewhere across the country.
It does. One of the primary reasons for this is that almost anyone doing basic biology on human cells uses cancer cells. The reason is not out of a desire to do anything with cancer, it's because most cells just sit there and do nothing, where as cancer cells keep growin
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My first thought... If doctors require so much bribing to get them to go along with the tests then how about just hiring one's own doctors as employees? Maybe there is som
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Is anybody really trying? When I am dying or debilitated from something that current medicine cannot cure I certainly
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Oh, its sketchy alright if you ask me. However, the company usually does genuinely only want to enroll patients that are likely to benefit from the drug (in theory), and which meet the other criteria for the trial. Even if you assume they have no care for human life enrolling people who aren't likely to benefit adds noise to the data, and you'll never see more careful design-of-experiment than you will in a drug trial. If the trial comes up with noise, the drug can't be approved. Companies routinely che
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As for the clinical trials, why not skip the doctors pocketing the money? Hire a couple doctors on to the trial and advertise for patients. That way over a year you burn through a million rather than 20 million and you get much less noisy data.
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It might work in very urban settings, but patients usually don't switch doctors based on advertisements for experimental drugs. Usually they stick with somebody they trust, and you need to bribe (err, compensate) them to recommend your experimental treatment.
To be fair participating in clinical trials does take time on the doctor's part.
If a national healthcare system were established I'd see this as a potential route to making this process FAR more efficient - you'd pay doctors a salary and not for piece-
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If the drug is something the patients truly need, they might. Or they would see the trial doctors like they might see any specialist.
At the same time, if it only works in urban settings, so be it. That's where the pharmaceutical companies are anyway. With that many million dollars at stake per trial, one might think it would be worth a bit of effort to bring those costs down.
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No, that does not include marketing; Pharma companies would much rather have their marketing dollars recognized as such every quarter, they're not going to bury that budget in research.
Prices are set at absolutely the highest prices the market will bear, but that's true in pretty much every market, even ones without giant sunk costs.
The marketing more than pays for itself in higher sales; the
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How can this be moded up? Is this fella one of them? Dude, are you 'one of them?' You sound threatening.
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Open sourcing things like education, arts, and soft/hardware is one thing. Messing with the pharmaceutical companies is entirely another
True that. And ask yourself this: where exactly did Bill Gates put his ill-gotten billions? But to tell the truth, Bill's cynical involvement just makes creating the alternative more of a sport. And in truth, usual barbarian hordes by all appearances would seem to be fed up with the ilk of Bill and his drug baron pals, and are even as we speak happily gearing up for the usual invasion.
And why is this necessary? Well put it this way: I saw that one day my aging Dad had to pay for meds without subsidy. Wow, o
"Patients and Physicians" (Score:4, Interesting)
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.
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Asking doctors and patients what kinds of drugs they'd like to have isn't a bad idea - pharmaceutical companies do it all the time, and perhaps not as often as they should. However, good marketing can't change the state of technology. If you surveyed everybody in my neighborhood I'm sure that a $1000 flying car would be right at the top of everybody's list. You'd waste a great deal of money if you tried to actually invent one, because the technology just isn't there yet.
It isn't like nobody knows what th
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pharmaceutical companies do it all the time, and perhaps not as often as they should.
They should do it more than all the time?
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You don't know that. Evidence indicates it's much more complicated. (e.g. http://www.youtube.com/watch?v=dBnniua6-oM [youtube.com])
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If you CHOOSE to eat more calories than you burn, you will gain weight. If you eat fewer calories than you burn, you will lose weight.
Well, duh, but why do people choose to eat more than is healthy for them? While most people aren't this extreme, there are people who literally cannot stop eating unless they're physically restrained - they would eat until they passed out from exhaustion, then wake up and start eating again, probably defecating on the floor next to the table. You can breed mice that do the same thing.
For whatever reason some people eat too much. Sure, it is voluntary, just like anybody can voluntarily saw off their own a
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Those are the extreme cases and are by definition rare. The kind that make the evening news when one dies and they have to knock a wall down to get the body out. These clearly have some kind of genuine medical problem (they're still bound by the laws of physics, however).
The
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These clearly have some kind of genuine medical problem (they're still bound by the laws of physics, however). They aren't the same as your common or garden lardarses.
Citation needed. I haven't seen any accepted scientific evidence that suggests that the difference isn't merely one of degree. I have no proof that it is either - more information is needed. However, I'm not willing to just dismiss anybody who is overweight as simply not caring to lose weight, let alone insult them. Your willingness to do both does not make you right, but believe what you will...
P.S. What was the point about calculus, other than to brag about how smart you think you are?
I wasn't bragging about my prowess at calculus - only about my inability to play ice hockey. The point was t
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A:WTF? You did all those ADME and pharmacokinetics studies, body surface area vs body mass dosing calculations, and liver function tests, and you're asking me??
I can actually see the utility in surveying people about that, assuming you manage your selection bias. Just because you did a PK/PD study on 50 people doesn't mean that there isn't a benefit from asking 10k people for their opinions. The first is high-quality info from a few people, and the second is low-quality info from many people. Both have uses, and if there is a big disconnect maybe there is some subpopulation that would warrant another study.
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I love all of the side effects placebos cause in clinical studies. It would be great to see patient's feedback asking that a sugar pill quit giving them horrible diarrhea.
Yup, I remember the TV ads for Claritin back when it wasn't generic. It had a laundry list of side-effects for legal reasons, followed by "similar to placebo." That basically means that as far as they could tell it has virtually no side-effects at all, but since somebody took it while they had a cold they had to say that it could give you a runny nose.
In fact, the sugar pill is the most dangerous pill of all - it causes everything from sneezing to death and yet it also has next to no health benefits. The
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I'm sure all the people dying in the third world would like to take their chances with a drug designed by less prestigious (or even less qualified) people than to receive none at all and die.
Roll your own LSD (Score:1)
I could have really gone for something like this about 20 years ago.
Hallelujah (Score:1)
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.
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An idea whose time as come. What a shame no one thought of it, or could make a credible beginning of it, sooner.
Lots of people have thought of it - I remember seeing comments on this on Slashdot years ago.
The beginning doesn't really matter that much - the question is how does it end. Unless somebody gives this company a ton of charity money (perhaps tens to hundreds of millions depending on luck) to actually pursue their work then they'll either collapse without actually coming out with a proven drug, or they'll have to sell out to a private investor in any number of ways, in which case the drug that does come out
Wellcome Trust? (Score:2)
There is a precedent for such groups (Score:5, Insightful)
May we have some new antibiotics? PLEASE????? (Score:5, Interesting)
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
Re:May we have some new antibiotics? PLEASE????? (Score:5, Interesting)
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 [wikipedia.org].
Mod parent interesting (Score:2)
"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.
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Yep, that soviet magic.
Problem is you have to fine tune it to the specific patient's infection, you can't just write them a script. Can't really see the american system being too hot on that, because most of the price would be lab labour based, and wouldn't go to a drug company. hmmm.
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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
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There's a name for those: other antibiotics.
Well, there's others, like nitric acid and fluorine. They aren't without side effects, however.
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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
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Also an arms race.
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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
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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 [slashdot.org] 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 cons
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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
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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 practic
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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
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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.
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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
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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.
No, because there's no money in it (Score:2)
"no money" is why I advocate public support (Score:2)
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????
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You nailed the issue. Antibiotics are a diminishing-return prospect, even if you get the government to fund them, and they are completely without profit for private industry.
My feeling is that we should be funding more antibiotics completely on the public dime, but we need to do a MUCH better job managing the antiobiotics we already have.
Even if a $500M antibiotic only saves a few thousand lives per year, that is still "only" a cost of a few hundred thousand dollars per life. That is pretty steep, but I s
"Open Source Drug Development" (Score:2)
Tropical diseases (Score:2)
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
Be creative, go around FDA (Score:2)
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 p
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Why not? FDA cannot come to a company and say: you can run studies of the drug, you cannot attempt to make a drug, etc. They are saying: you can't advertise and sell the drug without their approval, who is talking about advertising and selling? It's all done within the company, not in the market, not through drug stores. I don't think FDA is set up to deal with this type of regulation at all, and I don't even think it's doable.
This is just me, coming up with ways to defeat the damage of what government is,
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While the FDA may not be set up to deal with this type of regulation, I am quite confident that they would view it as an attempt to work around the regulations and insist that they
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Exactly - selling milk across State lines, and all that nonsense, that's what gov't is maintaining the highway system for (including 'interstate' highway in Hawaii). However this does not mean that the people, that are owners of the company, participating in very long term 'trials', and who are part of the 'quality assurance team' cannot work for the company and do what they must do to attempt and create a product. It's not a product on a market and trials must be done in order to bring the product to the
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It's not that I am against what you are suggesting. It's just that I am pretty sure that someone at the FDA has already closed the "loophole" you are suggesting that they exploit.
Relative to getting around the FDA, there was an article on here a week or so back about a company that only performs treatment at one location that the FDA is trying to claim falls under FDA regulation because it obtains some of its sup
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Human trials are done by companies, not by FDA, and I want to see FDA try and push a concept that they can shut down how a company works internally in this manner, all of a sudden, there will be a precedent set with weird consequences (there people working for the same companies in all States and across the border). In any case, FDA needs to be disbanded just like 99% of all other executive branches of the federal government.
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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.
I'm sure FDA regulations include anybody who takes a drug, including company employees. Believe it or not having scientists swallowing random pills isn't a normal part of pharmaceutical quality assurance.
And, even if you get rid of the FDA, you've just invited OSHA to ensure their working conditions are safe. Companies have to establish exposure limits for pills that scientists handle while wearing gloves, so what do you think the regulation around pills you actually swallow is going to be like?
Next they need a GPL for pharma (Score:2)
You can use my drug as an ingredient to newer drugs, as long as you keep my recipe open, etc....
Sounds like a gimmick (Score:2)
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.