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"Open Source" Drug Development Company Launched

samzenpus posted more than 2 years ago | from the wisdom-of-the-drugged-crowd dept.

Biotech 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."

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Careful... (3, Insightful)

pspahn (1175617) | more than 2 years ago | (#39143693)

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... (4, Insightful)

Rich0 (548339) | more than 2 years ago | (#39143805)

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... (5, Insightful)

ozmanjusri (601766) | more than 2 years ago | (#39143901)

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.

Re:Careful... (1)

justforgetme (1814588) | more than 2 years ago | (#39144439)

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...

Another Malthusian Failure (4, Insightful)

Okian Warrior (537106) | more than 2 years ago | (#39143909)

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 (3, Insightful)

Z34107 (925136) | more than 2 years ago | (#39144273)

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.

Re:Another Malthusian Failure (0)

Anonymous Coward | more than 2 years ago | (#39145349)

The idea of 'virtual drug companies' isn't entirely new. It's already part of the strategy of the Bill and Melina Gates Foundation - see http://www.ft.com/cms/s/0/36e4f5a4-b2fb-11e0-86b8-00144feabdc0.html#axzz1nIAaSuAL

Another thing you've got to remember is that drug development is hard. It's not like drug companies aren't staffed by scientists - they're all operating under the assumption that if they find a drug that actually works there will be profit at the end of it, meaning they're motivated to do genuinely successful research even if the driver is the base one of financial reward. The issues come when you add big business on top of that..

Re:Another Malthusian Failure (1)

Nrrqshrr (1879148) | more than 2 years ago | (#39145621)

I think he meant "The prototype drug won't work".
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#. Things work easilly in test tubes, half that easilly on rats, and then the gamble part starts when you try stuff on patients.

Re:Another Malthusian Failure (1)

AlexBirch (1137019) | more than 2 years ago | (#39145795)

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.

Re:Another Malthusian Failure (1)

ericspinder (146776) | more than 2 years ago | (#39145947)

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?

Re:Another Malthusian Failure (1)

Rich0 (548339) | more than 2 years ago | (#39146551)

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 this is just the next step in something Pfizer was already trying to do.

Re:Another Malthusian Failure (1)

Attila Dimedici (1036002) | more than 2 years ago | (#39147377)

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.

Re:Careful... (0)

Anonymous Coward | more than 2 years ago | (#39143923)

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.

The situation is very similar in the music industry, movie industry, consumer and small business software, book publishing, etc. The price of the product primarily reflects the sunken costs of development and marketing (including allowance for failed or non-hit products), as opposed to the variable costs of per-unit production.

People who post on this site tend to miss that, though. Or they claim that it doesn't matter because the creative talent are naive indentured servants who are ruthlessly exploited by coke-snorting, hooker-banging senior management.

Re:Careful... (0)

Anonymous Coward | more than 2 years ago | (#39144037)

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.

Well actually, pretty much anyone could do that. It's just highly unlikely that anything good would come of it.

Re:Careful... (4, Insightful)

Charliemopps (1157495) | more than 2 years ago | (#39144173)

"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.

Re:Careful... (1)

paiute (550198) | more than 2 years ago | (#39144225)

"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]

Re:Careful... (2, Informative)

Anonymous Coward | more than 2 years ago | (#39144297)

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.

Re:Careful... (1)

paiute (550198) | more than 2 years ago | (#39145945)

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".

Re:Careful... (0)

Anonymous Coward | more than 2 years ago | (#39147731)

Yes I know, I am not yet in possession of a PhD in biology but am working towards one. My knowledge of the flaws of the system is not singular either, my department was "graced" by a seminar on drug development by someone in management in of one of the major companies. He had the gall tell a room full of researchers that understanding was *irrelevant* to drug design no less than tree times, their reaction was a polite but strained "are you really saying that..."from one of the professors (after a shocked silence and lot of muttering in the audience).

I do understand that some people within the companies are aware of the problem, but it is their business to maximise profits and minimise risks, not to make drugs efficiently for the good of all. This combined with inertia means that any solution will not be quick. I am also aware that clinical trials still, as yet, outweigh the (ever increasing) costs of initial drug development, but that does not mean that the costs involved are small given the overall scale nor does it mean that understanding more of the system would not let you cut the costs of the trials. With a better understanding you could try to select safer more effective targets and potentially reduce the risks of later failures, or use direct molecular markers of the pathway targeted to see weather your drug is effective terminating the trial more quickly if it is not.

So long as the costs in financial risk exceeds the benefit they will not take advantage of this however, so despite the problem being deceptively simple I see no simple or easy solution. If there was such a solution I am confident someone more clever than me would already have implemented it, but the only way of solving this that I can see would probably involve bankrupting some of the biggest companies on the planet and would not necessarily work.

Re:Careful... (1)

dargaud (518470) | more than 2 years ago | (#39146361)

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 it way down, but big pharma complains "It costs billions to get a drug to market". 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
  • Testing indeed costs a large amount of money but needs the help of (public) doctors
  • 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)

To me the solution seems that Social Security should spin off a (large) drug testing division that does all the testing of all potential drugs with the (already) collaboration of public doctors but without the bribes that are currently used (all-paid WEs in high-end ski resorts for doc and family, etc). Even if the costs don't go down all that much, results will be public and social security will know what it pays for. No more botched testing like the current Mediator scandal.

And fabrication should be simply given to the lowest bidding pharma co... Which would save an additional bundle.

Now of course if you start screaming 'socialized medecine is evil', there's no need to reply.

Re:Careful... (0)

Anonymous Coward | more than 2 years ago | (#39146993)

What about monitoring drug safety after its released to the market? In the US at least the patent owner monitors the safety or both its own drugs and the safety of generics. Or providing accurate medical information to doctors? There are other huge costs you are ignoring

Re:Careful... (1)

Attila Dimedici (1036002) | more than 2 years ago | (#39147059)

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 company that gets the exclusivity to manufacture a drug is the one that spent the research dollars to develop and/or prove the safety/effectiveness of that drug (while I am aware that there are exceptions to the former, I am unaware of any exceptions to the latter--except in cases where the pharmaceutical company bought the company that did the latter).
Finally, you keep referring to Social Security. Social Security is purely a pension plan. For those who qualify, drugs and medical care are paid for by Medicare and Medicaid. Your ideas look interesting. However, if one looks at the history of medical costs in the U.S., one finds an interesting fact. Medical costs rose at a rate that directly correlated with inflation until 1966, when medical costs started rising much faster than inflation. What makes that fact interesting is that Medicare and Medicaid were created in 1965.

Re:Careful... (1)

dargaud (518470) | more than 2 years ago | (#39147579)

Well, I should have more explicitly stated that my example (and questions) applied only to countries with socialized care. What we call Social Security here in France. Apparently what you call Social Security in the US is an entirely different beast.

Re:Careful... (2)

jenningsthecat (1525947) | more than 2 years ago | (#39144285)

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?

Re:Careful... (0)

Anonymous Coward | more than 2 years ago | (#39146033)

Those socialist Canadians don't have a problem with drug costs, but unfortunately the GOP (and some Dems) block your ability to 're-import' drugs which would improve the competitive market. As Medicare pays if you are very, very poor, all you need to do in this country to afford those drugs is to quit your job, which plenty of people in your situation do all the time. Once Obamacare really kicks in in 2014, people who earn up to just over the poverty line will receive Medicare so you could get back to work then at least.

Re:Careful... (1)

Rich0 (548339) | more than 2 years ago | (#39146577)

"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 kinds of games.

Again, I'd love to see more public ownership of drugs as well. We're just not there yet.

Re:Careful... (0)

Anonymous Coward | more than 2 years ago | (#39144177)

There seems to be a single flaw in your model ... money.

Apart from that, it's the ideal way to develop life saving drugs.

Re:Careful... (0)

Anonymous Coward | more than 2 years ago | (#39144421)

You missed the key step. Drug companies spend more on marketing drugs than they do on developing them. The dirty little secret that they try to hide, claiming they need big profits and long patent periods to pay for research, cough cough marketing.

Re:Careful... (3, Insightful)

pepty (1976012) | more than 2 years ago | (#39145001)

Over the past ~fifteen years the big pharma companies spent 4 to 12 billion dollars on R and D per approved drug.

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; they wouldn't do it otherwise. The big cash sink for Pharma companies is stock buybacks: over the past decade their research efforts have failed so often that they've basically admitted that buying their own stock is a better way for them to compensate their CEOs, er, I mean protect shareholder value.

The main difference between pharma and every other business is just that business as usual becomes absolutely asinine when people's health is involved.

Re:Careful... Labrats/Mice (0)

Anonymous Coward | more than 2 years ago | (#39144909)

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).

Re:Careful... Labrats/Mice (1)

Attila Dimedici (1036002) | more than 2 years ago | (#39147143)

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).

Re:Careful... (1)

Anonymous Coward | more than 2 years ago | (#39145245)

How do clinical trials work?

Well there is basically 4 phases of clinical trial, at each step a drug can fail. At each step the holders of the active ingredients try to find investors, to jump on the gravy train. There is more risk to invest in the early phases than the later phases as the possibility of getting a drug to market increases with the passing of each phase. Every country has different criteria for passing a phase. Some countries are more stringent than others. The less stringent countries tend to be in the 3rd world. Having approval in one country can help to get approval in another. To reduce investor risk, many of them go to third world countries to start their clinical trials. Once they get their drugged approved in one 3rd world country, they go to the next until they have a bunch of approvals under their belt. They then go into the BRIC countries to get approval, then they move on to the western countries. Trying to make a buck in every step along the way.

Re:Careful... (1)

Mr. Freeman (933986) | more than 2 years ago | (#39145313)

And that doesn't even take into account the fact that they're going to make literally no money on this drug. If they release it open then every company will make generics. They can charge a lot less because all they have to do is retool their machines and hit "go" to start producing this drug. This "open" company has to somehow recover their R&D expenses.

It's a terrible solution to the problem of pharma companies profiting from the suffering of people. Switch to the universal healthcare option and on top of that start funding drug development. You'll end up with a lot more drugs that work a lot better and cost everyone less money. No more drug patents, no more incentive to create derivatives of the same drug so you can keep patenting one damn formula, no more incentive to create fifty pills for some stupid thing like erectile dysfunction instead of a harmful disease, no more reason for two companies to expend money doing the same research to race towards the same drug.

Re:Careful... (1)

Attila Dimedici (1036002) | more than 2 years ago | (#39147269)

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 for the same purpose.

Re:Careful... (1)

serviscope_minor (664417) | more than 2 years ago | (#39145659)

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 growing. This makes it tractable to perform transfections and mess with the genome. Also, they are really hard to kill which is handy because the process of getting them to do something interesting then observing them is fatal to many kinds of cell.

Also, there are a relatively small number of cancer cell lines and these have now been pretty well characterised which makes it much easier to measure meaningful effects.

Anyway, the bottom line is that researchers spend a lot of time messing with cancer cells for a lot of good reasons and this can get mis-reported very easily.

Re:Careful... (1)

morgauxo (974071) | more than 2 years ago | (#39146991)

Right, but this is the way it HAS to be? Really? I'm not arguing that your explanation of the process is wrong. But how about a little imagination and a new process? It's only the potential lifespans and quality of life of every human being on the planet at stake here, it's not like it's important enough to try to change or anything.

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 some sort of regulatory barrier to that? Get it changed! Yes, I know, getting things changed involved buying a lot of congressmen. How old is the average congressman? How about instead of buying them remind them of their own mortality? Ok Mr Congressman, you don't want to help make medicine better without getting big campaign donations? Fine! How's that heart doing? Any cancer in your family? What's the life expectancy for someone born when you were again?

Or is it an issue of assuring there is no conflict of interest? Maybe drugs should be tested by independent doctors before they actually hit an open market but drug companies could use their own doctors to weed out the dead ends first and only fork out the trial money on the ones their own tests show will actually work.

Is it an animal activist problem? No problem. They can get up on a soap box and shout about what is happening to the animals. First... be as blameless as possible. Take good care of those animals while they are alive, before (and if they survive) after the trials. Make them as happy as possible. Cause no more suffering than necessary. Got that done? Good! Now get up on your own soap box. If the animal activists are running ads with pictures of suffering animals then run ads with pictures of dying humans. Working on heart medicine? Show grandpa having a heart attack. Cancer? Show grandma with that. Better yet, show a little kid. You will still have a vocal minority against you but so long as you can dodge the occasional bucket of red paint the vocal majority that are for you will keep them in check. See... look how easy this is.

Insurance problem? That might be the hardest one to deal with. The best I can think of... publicize everything. If you are really trying to cure or prevent disease and somebody is making it hard for you there is no reason you shouldn't at least be able to get public outrage on your side. That might not actually win you anything but it certainly will not hurt. Really, that method could be applied to every problem. Make waves to get change.

Yes, I know this probably sounds pretty naive to somebody actually in that industry. I'm sure any change will be slow, very hard to accomplish and probably involve many failures along the way. So? The impression one gets as one affected by this (you know, the life expectancy/quality of every person on the planet thing) but not actually in that field by listening to people in medicine talk about it is that all most of them are interested in is accepting the status quot like it was written in stone by god or something. Barring an accident the day comes when we all need the cure for something or other, our life depends on it. Maybe worse yet are the possible several decades at the end of life where it's our quality of life that depends on it. Why aren't all doctors, researchers, etc... fighting to streamline this process as though their own lives depend on it? They do!!!!

Re:Careful... (1)

bogaboga (793279) | more than 2 years ago | (#39143885)

How can this be moded up? Is this fella one of them? Dude, are you 'one of them?' You sound threatening.

Re:Careful... (1)

Daniel Phillips (238627) | more than 2 years ago | (#39144367)

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, over a thousand dollars for one month for nothing exotic. And to think, normally we don't see that and it just comes out of our tax dollars. Talk about a tax on the stupid.

Re:Careful... (0)

Anonymous Coward | more than 2 years ago | (#39144443)

I think stuff like this can often meet an unfortunate end with a death under mysterious circumstances. I do hope it doesn't happened, but with such a large industry that has a large controlling interest of politics (FDA, etc.), it may be difficult to avoid. These are things the FBI/DHS do not care about, and will never choose to care about.

Re:Careful... (1)

Boscrossos (997520) | more than 2 years ago | (#39146785)

Been watching too many movies, have we? Even if they could just eliminate the upstarts without the law caring (and I doubt they do), it's much cheaper and more effective to just ensure that the startup gets so bound up in legal tape, sees its costs skyrocket, and ultimately goes under. It involves a lot less illegal activity, and creates a nice example for any other candidates who feel like trying this.

Re:Careful... (0)

Anonymous Coward | more than 2 years ago | (#39147385)

Actually, I'm worried for totally different reasons. The current system is screwed up, I don't think too many people would argue about that. Still, open source and involving users is good for many things (I love DIY stuff in general) but medicine is one of the few areas that could potentially be very bad. Let's not forget, going on "patients' experience" has given rise to a lot of quackery. And physicians (by which I feel like they mean "family doctors" and the like) aren't researchers, it's a totally different world. I wish them the best and hope everything goes well but I'm seriously doubtful of its success, never-mind danger from the pharmaceutical companies (who are probably more likely to laugh at them than sue them at this point).

I'm frustrated by people's (0, Redundant)

Anonymous Coward | more than 2 years ago | (#39143747)

inability to understand the apostrophe. It's means IT IS.

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.

Re:I'm frustrated by people's (-1)

Anonymous Coward | more than 2 years ago | (#39143857)

Fuck Africa, and fuck those god damn niggers. I was born and live in the USA, and I'm not happy about a lot of things in this country (in fact, the government really has a tendency to piss me off).

Slavery is the worst thing our ancestors did in my opinion; why bring those worthless black motherfuckers over here? Now they're getting more rights and protection from the government than us, they're fucking all the white girls and making god damn Oreos, and they're just fucking up the country and mankind--period.

Hell, there's a fucking nigger in the Oval Office running the country further into the ground right now after G. W. Bush sent us on a sharp downward slope, we've got Nigger Luther King Day that just passed recently and causes all government functions to cease, and on top of that Nigger History Month--for whatever reason--gets to torment us for an entire fucking month. Now, why did we bring them black fuckwads over here with us again? To do our work for us? Well, I'm sorry, but it wasn't worth it. Those assfucks should have been left in Africa where they could continue swinging with the monkeys in the trees.

Now not only would the niggers need to be sent back to Africa, but so would any nigger-loving whites--otherwise, they'd have the niggers return. It'd be better if the motherfuckers stayed in Africa, and any white nigger-loving whores just shut up and move there too. Just get all the niggers, nigger lovers and oreos out of here. All they do is complain anyway. Well they complain, drain the fuck out of social services and criminal justice systems, and produce more niggers at astounding rates like the ghetto rats they are. I mean hey when you don't have to worry about paying for them having 10 kids from 9 different daddies is easy!

"...and it is utter inability..." (1)

It'sVersusItsGuy (599536) | more than 2 years ago | (#39144195)

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.

"Patients and Physicians" (4, Interesting)

Anonymous Coward | more than 2 years ago | (#39143755)

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.

Re:"Patients and Physicians" (2)

Rich0 (548339) | more than 2 years ago | (#39143833)

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 the big disease targets are today. The problem is that nobody knows how to fix them, or if they have ideas they haven't yet found a drug that actually works in practice. That's a really expensive process.

If somebody figured out today that inhibiting some particular protein interaction would make us live to the age of 200, it would probably be 15 years and a few hundred million dollars before somebody got it right. It probably would only take weeks before somebody was inhibiting that interaction in a test tube, but it would take a lot of trial and error and tens of thousands of trial patients to figure out which molecule works in people and doesn't eat away their heart valves or whatever.

Re:"Patients and Physicians" (0)

Anonymous Coward | more than 2 years ago | (#39144045)

I am not a doctor. I just have some fuckin sense.

It isn't like nobody knows what the big disease targets are today. The problem is that nobody knows how to fix them, or if they have ideas they haven't yet found a drug that actually works in practice.

Like obesity? Drugs would be the wrong way to deal with that. What causes obesity? It's a lack of self-respect and self-discipline (really the same thing). It's also the inability for so many literate adults to grasp a concept you could explain to a 5 year old in a few minutes: if you eat more calories than you burn (known as "overeating" or "eating too much" or "time to put the fork down, fatty") you will gain weight.

How are you going to put that in a pill?

Seriously... deep down inside, even if they can fake a happy-go-lucky appearance, fatties are emotional trainwrecks who use food like a drug to get a moment of comfort since they can't handle life. Nothing is ever their fault even when it obviously is, they have a million excuses for why they cannot take control of their own behavior. Just like a cocaine addict in fact. Only difference is, the cocaine addict could quit doing coke and never touch it again for the rest of his life. The fatty has to learn to use food responsibly.

Again how do you plan to put that in a pill? Sure you can make a drug that limits appetite but how does that fix the inability to understand simple concepts like "don't eat more calories than you burn"? Maybe you could make a pill that makes it much, much more painful to overeat like the way we give AntAbuse to alcoholics?

Re:"Patients and Physicians" (1)

FormOfActionBanana (966779) | more than 2 years ago | (#39144501)

What causes obesity? It's a lack of self-respect and self-discipline (really the same thing)....if you eat more calories than[sic] you burn you will gain weight.

You don't know that. Evidence indicates it's much more complicated. (e.g. http://www.youtube.com/watch?v=dBnniua6-oM [youtube.com] )

Re:"Patients and Physicians" (1)

Anonymous Coward | more than 2 years ago | (#39144567)

What causes obesity? It's a lack of self-respect and self-discipline (really the same thing)....if you eat more calories than[sic] you burn you will gain weight.

You don't know that. Evidence indicates it's much more complicated. (e.g. http://www.youtube.com/watch?v=dBnniua6-oM [youtube.com] )

No, the mental gymnastics you need to deny it are complicated.

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.

This is basic physics. If you ate fewer calories than you burned and still gained weight then your body would be the first perpetual-motion machine. It's just not physically possible. The energy (measured in calories, aka what fat is storing) has to come from somewhere, there has to be excess energy that isn't being used so it requires storage. Like I said this is basic physics, it has nothing to do with what your feelings about it are. The physics involved is called thermodynamics.

If you think you can disprove modern thermodynamics then why are you wasting your time with me? Major scientific establishments would be interested in that. You would singlehandedly reverse the last few centuries of scientific thought in one fell swoop!

Of course, there's one thing I gurantee you is easier than singlehandedly reversing the last few centuries of scientific thought. Much easier actually. You know what that is? It's two things really. Either one works but it works better when you do both. The first thing is learning when to put the fork down, not because your gluttonous overstimulated appetite is finally satiated but because you know you've had enough, facts not feelings (remember fatties are emotional trainwrecks so logicaly their feelings [esp about food] are untrustworthy). The second thing is getting off your ass, shedding laziness, dropping all the excuses why you "can't" do it, and getting some exercise. One or the other will work but both at the same time says you actually do know how to commit to something.

Re:"Patients and Physicians" (0)

FormOfActionBanana (966779) | more than 2 years ago | (#39144671)

Are you a creationist, too? "It's just COMMON SENSE!!1" isn't it.

Re:"Patients and Physicians" (1)

Smauler (915644) | more than 2 years ago | (#39144533)

pharmaceutical companies do it all the time, and perhaps not as often as they should.

They should do it more than all the time?

Re:"Patients and Physicians" (1)

pepty (1976012) | more than 2 years ago | (#39145047)

Q: What kind of drug would you like to have?

A: One that costs $5, will cure me in one dose without side effects, and tastes like strawberries.

OK, we've got that covered.

Q:(From the Article) “Please think about medications you have tried. Were you likely to need a lower or higher than usual dose?”

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'm hoping the article isn't really reflective of the company's methods. Otherwise it looks like their best "innovation" (working out ways to have patients in clinical trials stay at home instead of repeatedly come back to hospitals to be tested) is something major Pharma companies are already doing.

Re:"Patients and Physicians" (1)

Boscrossos (997520) | more than 2 years ago | (#39146875)

I dunno. I regularly take 2 aspirin instead of one when I need them, on my doctor's advice. He said one would not be enough to suppress pain, since I am larger than average.

Re:"Patients and Physicians" (0)

Anonymous Coward | more than 2 years ago | (#39144825)

It's run and populated by pharmacologists and MDs.

Re:"Patients and Physicians" (1)

AlexBirch (1137019) | more than 2 years ago | (#39145811)

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.

Re:"Patients and Physicians" (1)

GameboyRMH (1153867) | more than 2 years ago | (#39147359)

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 (0)

scottbomb (1290580) | more than 2 years ago | (#39143781)

I could have really gone for something like this about 20 years ago.

Hallelujah (0)

TechForensics (944258) | more than 2 years ago | (#39143789)

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.

Re:Hallelujah (0)

Anonymous Coward | more than 2 years ago | (#39143827)

There are plenty of "open source" pharmaceuticals out there. It's you slobs who think that only the latest drugs are effective who've ignored some really great science and have become willing victims of the royal scam.

Re:Hallelujah (1)

Boscrossos (997520) | more than 2 years ago | (#39146893)

Well, alright, if you think homeopathy is spelled P-L-A-C-E-B-O.

Re:Hallelujah (2)

Rich0 (548339) | more than 2 years ago | (#39143853)

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 will cost $5/pill like everything else.

They're just doing the easy stuff right now - the kind of stuff happening in every University and start-up and established pharma company across the country. How many articles have you seen in the last 20 years about some idea that scientists think could cure some major disease? How many panned out remotely as well as was hoped, and how many were cheap for the first 20 years? Curing cancer in a test tube is easy.

Wellcome Trust? (1)

Kupfernigk (1190345) | more than 2 years ago | (#39145029)

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?

What About Drug Lobbies? (0)

Anonymous Coward | more than 2 years ago | (#39143803)

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?

There is a precedent for such groups (5, Insightful)

postglock (917809) | more than 2 years ago | (#39143899)

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 [osdd.net] 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".

Re:There is a precedent for such groups (1)

Sivaraj (34067) | more than 2 years ago | (#39144003)

Mod parent up!
OSDD seem to be more in tune with FOSS philosophy (no patents, generic, free to copy drugs) than TLS. I don't think TLS is going to release their drugs unpatented. At best we can call TLS a crowdsourcing scheme.

May we have some new antibiotics? PLEASE????? (4, Interesting)

PeterM from Berkeley (15510) | more than 2 years ago | (#39143929)

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????? (5, Interesting)

Kozz (7764) | more than 2 years ago | (#39143991)

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 (1)

SteveFoerster (136027) | more than 2 years ago | (#39144087)

"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.

Re:Mod parent interesting (1)

mirix (1649853) | more than 2 years ago | (#39144337)

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.

Re:May we have some new antibiotics? PLEASE????? (2)

PeterM from Berkeley (15510) | more than 2 years ago | (#39144595)

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

Re:May we have some new antibiotics? PLEASE????? (1)

Hognoxious (631665) | more than 2 years ago | (#39145191)

chemicals which disable bugs from being able to resist antibiotics

There's a name for those: other antibiotics.

Well, there's others, like nitric acid and fluorine. They aren't without side effects, however.

Re:May we have some new antibiotics? PLEASE????? (1)

PeterM from Berkeley (15510) | more than 2 years ago | (#39147375)

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

Phages as biocontrol/therapy - The Next Big Thing? (1)

staalmannen (1705340) | more than 2 years ago | (#39144719)

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.

Re:May we have some new antibiotics? PLEASE????? (1)

ceoyoyo (59147) | more than 2 years ago | (#39147853)

Also an arms race.

Re:May we have some new antibiotics? PLEASE????? (2)

fuzzyfuzzyfungus (1223518) | more than 2 years ago | (#39144101)

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...

Re:May we have some new antibiotics? PLEASE????? (1)

PeterM from Berkeley (15510) | more than 2 years ago | (#39144609)

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

Re:May we have some new antibiotics? PLEASE????? (1)

kiwimate (458274) | more than 2 years ago | (#39144105)

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 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 [slashdot.org] points out why most /. posters won't get that, ever.

Re:May we have some new antibiotics? PLEASE????? (1)

PeterM from Berkeley (15510) | more than 2 years ago | (#39144645)

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

Re:May we have some new antibiotics? PLEASE????? (0)

Anonymous Coward | more than 2 years ago | (#39145153)

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.

Re:May we have some new antibiotics? PLEASE????? (1)

sudo (194998) | more than 2 years ago | (#39144129)

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.

Re:May we have some new antibiotics? PLEASE????? (1)

Gaygirlie (1657131) | more than 2 years ago | (#39144155)

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.

Re:May we have some new antibiotics? PLEASE????? (1)

Daniel Dvorkin (106857) | more than 2 years ago | (#39144547)

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.

Re:May we have some new antibiotics? PLEASE????? (1)

PeterM from Berkeley (15510) | more than 2 years ago | (#39144631)

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

Re:May we have some new antibiotics? PLEASE????? (1)

PeterM from Berkeley (15510) | more than 2 years ago | (#39144635)

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

Re:May we have some new antibiotics? PLEASE????? (1)

thatskinnyguy (1129515) | more than 2 years ago | (#39144263)

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.

Re:May we have some new antibiotics? PLEASE????? (1)

augasm (925153) | more than 2 years ago | (#39144559)

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.

No, because there's no money in it (2)

at0mjack (953726) | more than 2 years ago | (#39145499)

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.

"no money" is why I advocate public support (1)

PeterM from Berkeley (15510) | more than 2 years ago | (#39147331)

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

samzenpus must be killed... (0)

Anonymous Coward | more than 2 years ago | (#39144109)

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.

Open Source drug company? (0)

Anonymous Coward | more than 2 years ago | (#39144121)

But I've got to admit, if there's one movement which needs drugs..

"Open Source Drug Development" (1)

thatskinnyguy (1129515) | more than 2 years ago | (#39144231)

What could possibly go wrong?!

Re:"Open Source Drug Development" (1)

Anonymous Coward | more than 2 years ago | (#39145223)

The same things that can go wrong with regular for-profit drug development, actually.

Tropical diseases (1)

AHuxley (892839) | more than 2 years ago | (#39144447)

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.

Be creative, go around FDA (1)

roman_mir (125474) | more than 2 years ago | (#39144829)

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.

Re:Be creative, go around FDA (0)

Anonymous Coward | more than 2 years ago | (#39144921)

They need to be creative and go around all of the FDA rules.

You really don't have to be that creative, you just need to call it "natural," or say that it's a food "supplement" and not a drug. If you really want to save on manufacturing costs, you can just dilute it so much that you're just selling a bottle of water and call it "homeopathic." All of the profits with none of the hassle of testing!

Re:Be creative, go around FDA (1)

ronpaulisanidiot (2529418) | more than 2 years ago | (#39145887)

yes, how dare the fda prevent people from taking poison as medicine. we should be free to buy liquid mercury as a cure for whatever ails us! bring back the blood letting, too - it worked so well for george washington!

Re:Be creative, go around FDA (1)

Attila Dimedici (1036002) | more than 2 years ago | (#39147557)

I am pretty confident that there is no way that would work to let them get around the FDA rules. The problem with the FDA is that every time a drug gets approved that has significant negative side-effects, everybody notices and says, "How did they let that through? Why did they ever approve that drug?" However, no one ever notices the promising drug that the drug companies quietly drop because FDA rules make it to expensive to get approved to bother with (and the people who suffer and/or die as a result of this drug never being brought to market). Or the drug that is delayed being brought to market because of all of the hurdles that the FDA puts in place. As a result of this, people working at the FDA have lots of incentives to put up roadblocks to approving new drugs and no disincentives to doing so.
The only possible solution I can see would be to move the responsibilities of the FDA to the state level and let different states try different approaches to drug approval. There are problems with that as well, but the current system is broken and there is no easy answer. If more things that the federal government does were left to the states, the various states could try different approaches and we could see which one worked best (additionally, some of the things the federal government does are broken because what works best New York is different than what works best in Alaska).

Re:Be creative, go around FDA (1)

roman_mir (125474) | more than 2 years ago | (#39147753)

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, routing around the damage. Same thing as what all businesses are doing. Government is damage, businesses and people are routing around it.

Can OSS reduce the cost of clinical trials? (0)

Anonymous Coward | more than 2 years ago | (#39147015)

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/.

Next they need a GPL for pharma (1)

mrflash818 (226638) | more than 2 years ago | (#39147759)

You can use my drug as an ingredient to newer drugs, as long as you keep my recipe open, etc....

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