What Is Open Source Pharma (and Why Should You Care)?

Andy Updegrove writes: Humanity today is almost completely dependent on huge pharmaceutical companies to create the drugs we need. But these companies focus exclusively on drugs that can be sold at high prices to large populations — in other words, to patients in developed nations. This means that those who live in the emerging world that suffer from the remaining 'neglected diseases,' like Malaria and drug resistant TB, have no one to depend on for relief except huge charities, like the Gates Foundation. They also have no way to afford many of the patented drugs that do exist. But there is another way, modeled on open source software development, which relies on crowd sourced knowledge, highly distributed, volunteer efforts, and advanced open source tools. That methodology is called Open Source Pharma, and it has the potential to dramatically drive down drug development while saving millions of lives every year.

Comments

malaria is not negected

[turkeydance]

melinda gates doesn't,anyway.

Re:malaria is not negected

[pepty]

The summary and the article don't entirely impress.

But these companies focus exclusively on drugs that can be sold at high prices to large populations

The FDA created incentives for Pharmas to pursue orphan drug indications and guess what? Pharmas pursued orphan drugs: http://blogs.wsj.com/pharmalot...

Specifically, there were 467 requests for orphan designation last year by the pharmaceutical industry, which represented a nearly 35% increase from 2013, and 293 drugs were granted orphan status by the FDA Office of Orphan Product Development. This amounted to a nearly 13% increase. Ultimately, 49 orphan drugs were approved by the agency, up 53% from 2013. A designation, by the way, means the FDA has decided a drug qualifies for orphan status.

The article:

Most of this anecdotal evidence ends up going nowhere, because there is no easy way for overworked physicians to post and aggregate such possibly random, but occasionally very significant observations. The possibilities here are enormous, because so many of these drugs are already generic, and they have already been approved by the appropriate authorities. Such “off label” uses of very inexpensive, repurposed drugs can be immediate, and lifesaving.

Be very careful what you wish for. For one thing, as you can read everywhere, the aggregate of anecdotes != data. It is very hard to separate the signal from the noise, especially when you are desperate to see a signal in the noise. Andy Groves is infamous for not realizing this and many other differences between the semiconductor and the pharma industries.

For another, if the open source effort succeeds in datamining a possible new indication for a generic drug the prime beneficiary will be (Surprise!) the most predatory pharma companies. Exclusive marketing rights don't start or end with a patent. In the US, you can get exclusive rights by running a trial that finds a new indication for a generic drug. So while the open source folks are begging on GoFundMe, some outfit like URL Pharma will have looked at the open source data, run a trial, gotten approval, and run up the price on the drug 1500% while preventing anyone else from selling it for at least three years. See: Colchicine

Big Pharma is both much more asinine and much more useful than folks give them credit for.

There's more to it than developing the drugs.

[ScentCone]

Crowd sourcing years of clinical trials. What could possibly go wrong.

Re:There's more to it than developing the drugs.

[ArmoredDragon]

This.

Not only that, but what happens when you end up with drugs that work incredibly well, only they include a very nasty (and deadly) side effect that wasn't found in the clinical trials? (See Fen-Phen.) Who pays in that case? This is why drug companies want patents. They HAVE to charge a high price and make big profits, otherwise the risk is NOT worth the reward.

I'm not opposed this kind of movement, but I'm going to remain skeptical about its viability until the above two problems can be solved. Not only that, but in many cases you're looking at costs that range in the billions of dollars before you'll see even a dime worth of profit, and even then, profit isn't guaranteed.

Open source tends to work because just anybody can pick up a programming book and learn to code, and know really quickly whether or not it will work. But nobody can very quickly tell if a drug they're developing has no dangerous side effects, and doing so often involves risking somebody else's life and not necessarily your own. Medical professionals don't experiment like this because it goes against their code of ethics.

Re:There's more to it than developing the drugs.

[currently_awake]

Reasons for government to do all drug research: #1-drug companies do research for profit only, unprofitable drugs don't get developed no matter how many lives it would save. #2-high cost and risk of developing new drugs. #3-developing a cure is less profitable than a treatment, so corporations would only make the treatment. The drug companies should only do production and distribution.

Re:There's more to it than developing the drugs.

[Impy the Impiuos Imp]

I'm not opposed this kind of movement, but I'm going to remain skeptical about its viability until the above two problems can be solved

This. We want "Big Pharma" inventing drugs. Expensive new drugs are better than none, which is the only real choice. We want government doing basic research, even though it is a fraction of private investment. We want tesing of folk remedies, and ass sweat from some monkey in South America, and some frog venom that wasn't discovered until three weeks ago.

The prime problem for humanity is, always has been, and continues to be, death. Not this or that right, or political system, or whatnot. Death. And the vast bulk of that is disease and natueal process.

Re:There's more to it than developing the drugs.

[the gnat]

Crowd sourcing years of clinical trials. What could possibly go wrong.

I don't disagree with this point - pharma industry critics tend to be very ignorant of what the process actually looks like, and how much it costs - but one of the points made by the article was that Big Pharma might not waste so much time and money on failing drug candidates if they had access to more complete information*, i.e. if data sharing was the norm rather than the exception. Crowd-sourcing the clinical trials sounds like a recipe for disaster, but crowd-sourcing the early discovery process might have some real benefits. It's not like the entire process could get any less efficient, and even just keeping the number of failed clinical candidates to a minimum would be a huge improvement.

(* Granted, the fact that most academic research is stuck behind publisher paywalls makes their job far more difficult than it should be. I get nauseous every time I think about how much damage our publication practices have done to modern science.)

Re:There's more to it than developing the drugs.

[Kohath]

#4 When your government drug has a crippling side-effect, you can't sue them. No one at the government has anything to lose.
#5 When you have a disease that you need treatment for, you get research and treatment based on how politically powerful (usually meaning how popular and fashionable) you and your fellow disease-sufferers are. You're a popular political heavyweight, aren't you?
#6 You compete for budget resources with retirees on benefits and children who need schools. You're more powerful than retirees on benefits and more sympathetic than young children, aren't you?
#7 Companies have to hurry to bring drugs to market before the patent expires. Governments can take their time. You don't want to be cured or treated soon, do you?

Re:There's more to it than developing the drugs.

[tsotha]

Yep. Excitement over this sort of thing is based on a false assumption - that drug targets are the expensive part. They're not.

Re:There's more to it than developing the drugs.

[rtb61]

#8 The drugs researched by government can be produced by any suitable company and they must compete on price. This eliminates patent extortion, pay 10,000% margins or suffer die, when done by truly psychopathic corporations. If fact a huge proportion is done by government at taxpayer expense only to see that research sold to private corporations for cents on the dollar. Stop the bullshit, the only thing private does better than government is feed the greed of psychopaths.

Re:There's more to it than developing the drugs.

[ArmoredDragon]

Reasons for government to do all drug research: #1-drug companies do research for profit only, unprofitable drugs don't get developed no matter how many lives it would save. #2-high cost and risk of developing new drugs. #3-developing a cure is less profitable than a treatment, so corporations would only make the treatment. The drug companies should only do production and distribution.

Ok I'll need you to take off your rose tinted government issue glasses for a minute. Consider the fact that the US has a smaller GDP than the combined EU, and the EU governments take in more taxes than the US government.

Now ask yourself, why is it that the world's most advanced medications always come from for profit corporations in the US, and nowhere else? Why is it that the US is by far the most popular destination for medical tourism, even though in the US, hospitals are owned by private, for profit corporations?

Clearly because government run medicine is so much better, right?

Re:There's more to it than developing the drugs.

[Kohath]

In other words, you were cured of your deadly disease and you get to live another 40 years, but someone made a profit so it wasn't worth it.

Re:There's more to it than developing the drugs.

[Kohath]

Yeah, I get it. It's too much profit, so nevermind being cured of your deadly disease. Those extra 40 years you get to live are an obscenity because the guys who cured you got paid way too much.

Re:There's more to it than developing the drugs.

[davester666]

You only live those 40 years if you happen to be rich enough to afford it.

Re:There's more to it than developing the drugs.

[sjames]

No, you died because you couldn't afford it. Or you were left unnecessarily bankrupt and died years early because THAT kept you from getting decent healthcare.

There's profit and then there's obscene profiteering.

Re:There's more to it than developing the drugs.

[sjames]

Too bad you're wrong. India and Singapore are the hot medical destinations. Mexico is popular for Americans who need expensive dental work. There ARE people who travel to the U.S. for medical care, but more people travel FROM the U.S. to get medical care.

I have no idea where you got the idea that all of the drug development happens in the U.S.

Re:There's more to it than developing the drugs.

[Kohath]

But someone else was cured, and it's not fair, so the disease should never have been cured to begin with. (Even though the patent runs out in 8-12 years and then everyone who ever gets the disease from that day until the end of time can get a cheap cure for it.)

Re:There's more to it than developing the drugs.

[Kohath]

No. Dying in the desert is never fair. Getting sick or hungry isn't fair. Everyone should live forever in perfect health or it's not fair. Why does President Obama let all this unfairness keep happening?

Re:There's more to it than developing the drugs.

[sjames]

OH, you're a KOOK! You should have said so and saved me the trouble of replying.

Re:There's more to it than developing the drugs.

[sjames]

No, it should have been offered at an affordable price.

It's funny how they magically find a way to do that when the drug is at all optional.

Re: There's more to it than developing the drugs.

[koomba]

I think rtb kind of has a point, some medicine costs are just obscene, particularly in a hospital setting. My dad is an ER pharmacist, so I get to hear all kinds of stuff about insane drug prices. One example: someone came in recently that had been bitten by a dog, and they didn't know if it had rabies or not. He didn't have insurance. And with rabies, you can't just wait and see if symptoms appear, if you have contacted it, the antidote must be given long beefier symptoms appear, or you could be in trouble. And the price for the antidote paying with no insurance? $40,000. So hmmm, just pray the dog didn't have it? Blow 40k incase it did? No good choices there.

Re:There's more to it than developing the drugs.

[Kohath]

I hope you can sleep tonight knowing companies are still out there making large profits by curing people of deadly diseases.

Re: There's more to it than developing the drugs.

[Kohath]

Obviously the good choice is to have insurance. This is exactly what insurance is for, to protect you from financial loss in case of an unlikely mishap. It's the same as if your house caught on fire.

A dog bite isn't an emergency. For $40k, you take a few hours to find the dog to get it tested for rabies, and failing that, you'd shop around for someone who might charge less than $40k. If you had to pay the $40k, you'd still want to find the dog afterward and get his owner (or his owner's liability insurance provider) to pay you back.

Re: There's more to it than developing the drugs.

[Anonymous Coward]

Which is why everybody should have insurance, paid by the state if they can't afford it themselves. (Or more to the point, basic health care should be free -- treat diseases as soon as they appear, give out free vaccines, prevent epidemics. Didn't we learn anything from the Ebola disaster?)
Similar answer to "who pays for unforeseen nasty side effects": when no negligence or malpractice can be shown, there should be an insurance to cover these risks.

Re:There's more to it than developing the drugs.

[sackvillian]

Clearly because government run medicine is so much better, right?

The US pays its doctors some of the highest salaries in the world, publishes the most and best medical research in the world, and also charges its patients the most in the world.

You can find the best and worst care in the US. For the rich who want the best care -- American or not -- the US is their destination of choice. It's just that the rest of the developed world gives a damn about providing decent care to the vast majority of citizens who are not rich. By focusing on that, they take care of the rank and file and still leave the opportunity for the richest to travel abroad to pay through the nose for better care, so nobody really suffers.

And as the poster below points out, medical tourism is not exactly the best metric of your system's quality. India and Mexico aren't exactly shining models of medical care.

Re: There's more to it than developing the drugs.

[Billy the Mountain]

Rabies vaccine is only $40k? What a bargain Hepatitis C drugs cost $80k.

Re:There's more to it than developing the drugs.

[currently_awake]

What is worse: dying of an incurable disease, or dying because you can't afford the 1 million dollar cure? The COST isn't just lefty hand waving, it's a matter of who can get the cure.

Re:There's more to it than developing the drugs.

[Stan92057]

ya know darn well its about those who cant get the drugs. A living patent poor or otherwise is a taxpayer until they die. A dead person pays no taxs buys nothing. The profit margins are insane, a pill made for a horse that can be broken into 10 pills is 99% cheaper the 1 pill for a human, that's is a fact, and your ok with that? That not about profits that is pure greed.

Re:There's more to it than developing the drugs.

[sjames]

Here's one.

Re:There's more to it than developing the drugs.

[Kohath]

Buy insurance, so you can get the cure and only pay the deductible.

Everybody wins. Sick people get cured. Healthy people are already winners because they're healthy. Drug companies get paid and get a really nice incentive to keep finding disease cures. The insurance company tries to negotiate costs down so they can make a profit. Insurance buyers force the insurance companies to compete for their business.

Re:There's more to it than developing the drugs.

[tgrigsby]

I believe sjames just took off your Fox "News" color sunglasses. Blink a few times -- the sudden glare of truth can be blinding at first...

Yes, drug development happens in the U.S., but inexpensive treatment happens everywhere BUT the U.S, largely because of the obscene profit margins on medicine, medical procedures, etc.

Re:There's more to it than developing the drugs.

[wv5k]

How about a link containing something a bit more current than seven years ago??

Re:There's more to it than developing the drugs.

[exomondo]

Not only that, but what happens when you end up with drugs that work incredibly well, only they include a very nasty (and deadly) side effect that wasn't found in the clinical trials? (See Fen-Phen.) Who pays in that case?

If it's based on the Open Source model then nobody pays because nobody is directly responsible. The idea is the information is available free and the end user is the one that has to make the decision because they have all the information.

I'm not opposed this kind of movement, but I'm going to remain skeptical about its viability until the above two problems can be solved.

It's all really going to have to come with an Open Source Software -style "no warranty" disclaimer and when it comes to healthcare you can bet if something goes wrong the first thing will be the question of "who can we blame and sue for millions of dollars". I'm sure it will be a legal mess to have a drug manufacturing company that is completely absolved of responsibility - and of course needs to be due to the low profit margins - or even worse for everybody to have a pill press and make their drugs themselves.

Open source tends to work because just anybody can pick up a programming book and learn to code, and know really quickly whether or not it will work.

And even if it works most of the time but has some critical crash in a few niche cases it's going to be useful and can potentially be patched, the consequence of a drug working most of the time but having some critical side effect in a few niche cases is much more severe. You can't just say "hit 'save' more frequently and if something goes wrong just restart your system".

Re:There's more to it than developing the drugs.

[exomondo]

No, it should have been offered at an affordable price.

Then get cracking on starting a research center and clinical trials, patent your results, freely license them and let's see if it's sustainable. There's always a bunch of keyboard warriors telling everybody that the experts in the field are doing it wrong and that *this* is how it should be. Maybe if you SJWs actually *did* something rather than just whining about it you might succeed or perhaps you might realize that reality doesn't quite match your idealized view of what it should be. Either way you're not going to find out until you try.

Re:There's more to it than developing the drugs.

[pepty]

You are discounting the Wisdom of Crowds. Just hand 10000 people the data and ask them "Does this drug show efficacy for non-Hodgkins Lymphoma?". The answer will surely be correct to within +/- 10 jellybeans.

Re:There's more to it than developing the drugs.

[pepty]

#1. If the drug would theoretically save many lives (in the US) at all, it would be profitable. #2. So Congress, with its great respect for science, will be a great arbiter for deciding which drug research projects should get billions of dollars? #3. NO. This is a common fallacy. A cure for any serious ailment would be an absolute goldmine for a pharma. They would price it much higher than any treatment and drive out almost all competition in the market (the ones selling treatments, not cures) in months. Plus, they would get all of their revenue NOW, as opposed to having to sell it for a decade or more.

Want to book $10B in revenue in five years? invent a good diabetes treatment. Want book two trillion dollars in revenue? Invent a cure for type II diabetes. Seriously. It would have a stated price of $50k+, sell for an average price of ~$25K, and easily sell 80 million doses in five years.

Re:There's more to it than developing the drugs.

[pepty]

Year in, year out, about 25% of new drugs (NCEs) are invented by public research. 75% are invented by pharmas/biotechs.

Re:There's more to it than developing the drugs.

[pepty]

Sometimes it is an obscenity. Price of your asthma inhaler (albuterol) goes up 1000% because of a patent on a new CFC-free formulation that's no better (for the patients) than the now banned version that has CFCs? Run a quick trial on a generic drug (colchicine) and run the price up 1500% for three years because the FDA gave you exclusivity? Use FDA legal gamesmanship to prevent generic manufacturers from getting the samples of your drugs (Lenalidomide, Bosentan) necessary for them to get approval of their generic version of your drugs?

All seem pretty obscene to me.

Re:There's more to it than developing the drugs.

[pepty]

1. Your first paragraph doesn't inform your second paragraph at all.

Re:There's more to it than developing the drugs.

[pepty]

Now ask yourself, why is it that the world's most advanced medications always come from for profit corporations in the US, and nowhere else?

Sorry to burst your bubble, but three of the top 5 Pharma companies (global sales 2014) are Roche, Novartis, and Sanofi.

Re:There's more to it than developing the drugs.

[pepty]

and the end user is the one that has to make the decision because they have all the information.

And a strong background in pathology, statistics, pharmacology and a few months free to review the information and make an informed, rational choice not clouded by desperation or painkillers?

Re:There's more to it than developing the drugs.

[sjames]

Two separate thoughts in two separate paragraphs. Where's the confusion?

Re:There's more to it than developing the drugs.

[exomondo]

Exactly! It's very much like Open Source software, the advocates tell you it's great because you can see the source and see what it does but that is completely disingenuous argument given that very few people are going to understand the full breadth and consequences of what they are seeing. Now of course in pharmaceuticals the consequences of not understanding it are likely much more dire.

Re:There's more to it than developing the drugs.

[david_thornley]

Market economics generally works better for distributing applied development resources, like the pharma companies do. We definitely want government-supported basic research, because market economics sucks at encouraging that.

A drug that saves a lot of lives is profitable. We can have programs for government support of drug R&D for drugs that will help a relatively small number of people (IIRC we have one already), but there have to be limits.

I fail to see how government-controlled research is gong to be cheaper than private-sector research, and we want drug companies to take risks in developing new drugs, since some of them pay off big. If you mean the government should help individuals with the cost of expensive drugs, I'm completely with you.

If drug company A has a treatment for something, and drug company B comes out with a cure, who's going to get the sales? As long as we have competing companies, we don't have to worry about a cartel manipulating pharmaceutical research for evil ends.

Re:There's more to it than developing the drugs.

[Anonymous Cow Ward]

When you say "predatory margins of 10,000%", are you comparing sale price and cost to produce? Because that's incredibly disingenuous; you have to include R&D costs as well, and not just for that drug, but for all the drugs that they put money into but failed clinical or preclinical trials.

Crap crap crap

[Hognoxious]

Humanity today is almost completely dependent on huge pharmaceutical companies to create the drugs we need.

No it isn't. Most people don't have access to modern medicine at all.

Oh, and for fuck's sake stop referring to anything other than software as open source.

Re:Crap crap crap

[Anonymous Coward]

OK. But we need new pharmaceuticals to treat our open sores.

Re:Crap crap crap

[Ungrounded Lightning]

[intensifier] stop referring to anything other than software as open source.

I'm perfectly happy to also use (as the spook community does) "open source" to apply to intelligence gathering by scraping and analyzing the net, news media, government publications, and other generally available information rather than limited-access stuff brought in by spy networks.

It's a slightly different meaning of "source", but an entirely apt usage of the two-word string.

Good luck...

[Anonymous Coward]

If Open Source Pharma works out like a lot of the Open Source (insert thing) projects I've seen lately where money is involved. The people in a position to make the money will do so while milking the community and then inexplicably decide to go closed source and then sell out to a larger established corporation.

Re:This will be stopped

[ihtoit]

TPP will have no teeth as long as BRICS is allowed to continue.

Maybe find a cure for cancer and more

[kbsoftware]

The pharmaceutical industry is not very motivated to find cures for diseases as it would mean less money after a year of so of finding the cure. Just look at cancer research something like $125 billion dollar a year industry. Can you imagine how much money some of the board members are making. So I'm hoping the open source pharma movement will be that movement that will be truely motivated to find cures for diseases like cancer. A problem I do see here is like I say the pharmaceutical industry would feel the impact of someone else finding the cure so I suspect if they even think just a little bit that the open source pharma could find cures that the industry will start lobbying politicians big time to make open source pharma illegal and oh can't wait to hear about all the lawsuits they will bring to try and destroy the movement. So I'm hopeful but I do expect the pharmaceutical industry to do everything in their powers to destroy the open source pharma so tough times ahead.

Actually no

[rsilvergun]

most of the (expensive) basic research is still done on the public dime. Then big pharma comes in, runs a few (cheap) clinical trials, patents the whole shabang and blamo, new drug. You didn't think mega corps actually paid for things like us little people, did you?

Re:Actually no

[ShanghaiBill]

Then big pharma comes in, runs a few (cheap) clinical trials

Clinical trials are not "cheap". They are usually the most expensive part of bringing a new drug to market.

Re:Actually no

[LetterRip]

Clinical trials are not "cheap". They are usually the most expensive part of bringing a new drug to market.

The expensive trials are when we have a drug that treats the problem extremely well, the new drug appears to offer little or no benefit, and thus they have to offer people ridiculous sums of money to be recruited into the trial, and they have to have a enormous number of people enter the trial to show an effect size.

For trials where there is no effective treatment, and the new treatment should be highly effective, the cost of trials is quite modest.

Re:Actually no

[the gnat]

For trials where there is no effective treatment, and the new treatment should be highly effective, the cost of trials is quite modest.

The problem is that a lot of the proposed new treatments turn out not to be highly effective, but companies don't find this out until they've already sunk tens or hundreds of millions of dollars into it. So the cost of every new FDA approval needs to be balanced against all of the bets that failed.

This is true even for diseases where there isn't an effective treatment - clinical trials for Alzheimer's drugs (a sure money-maker, if they worked) have been notoriously failure-prone.

Re:Actually no

[RandCraw]

Yes. Clinical trials are famously expensive -- no less than $100 million US for any drug that is not fast tracked, which reduces development time (and cost) by no more than half.

In general only untreatable mortal diseases like cancer or infection can fast track a drug. The other 95% of drugs go through probably 5 years of compound identification, tuning, and testing, then 5 years of preclinical trials in multiple animal species, then another 5 years in humans before approval. (Yes, that's about 15 years.)

The last phase of development (clinical trials) is unavoidably very expensive (80% of the overall cost). And no amount of free software or volunteerism is going to change that appreciably. Even now, all patient participants in clinical trials are already volunteers.

The cost of a new drug lies in planning, testing, write up, peer review, and great gobs of regulatory oversight and process. Open source cannot change that.

Re:Actually no

[CanadianMacFan]

Once it comes to human testing there are three stages. The first is with healthy people and they are given the medication in various doses to ensure that it isn't dangerous (or at least cause problems greater than what they expect). The second stage tests how effective the medication is. This is done in patients with the disease/ailment and in this stage they fine tune the dosages. The third stage is the one in which it compares the new medication with the best existing treatments, if possible, and a placebo treatment. If a drug or treatment offers little to no benefit then it won't be approved. However, the definition of providing benefit does seem to be pretty loose sometimes.

Re:Actually no

[sjames]

A real question, what's so damned expensive about giving people a drug and seeing if they get better or not? Particularly after phase I where you have already determined that it is more or less safe for human consumption.

Re:Actually no

[RandCraw]

I know more about nonhuman studies than clinical, but according to the US HHS (who runs FDA), the breakdown of costs are these:

- $15k/patient for phase I
- $20k/patient for phase 2
- $25k/patient for phases 3 and 4

The cost of the average trial:

- phase 1: $4 million
- phase 2: $13 million
- phase 3: $20 million
- phase 4: $20 million

Some phase 3 trials can be larger and last longer than average, like 20,000 patients over 5 years. Obviously at the average cost of $25k/patient, such a trial would cost $500 million, well over the average. In fact, a long study can greatly increase the per patient cost as well.

Because multiple trials are run in each phase for each drug, these trial costs are multiplied.

The principal cost in any trial are the medical procedures (~25%): drug administration, tests (lab, imaging, biopsy, etc), exams, etc. These are repeated multiple times on each patient during each trial to monitor changes in both efficacy and safety.

Here's a thorough accounting from US HHS:

http://aspe.hhs.gov/report/exa...

These costs are set by FDA regulatory standards and the medical laws of each country where the trial is performed. Of course if you want approval for your drug in another country, you must comply with all their rules as well, often repeating studies using their residents (e.g. Japan).

This 2012 Forbes article by Avik Roy offers further insight on why clinical trial costs are rising:

http://www.forbes.com/sites/ar...

Pharmas must play by these rules, but they don't write them. Lawmakers do that.

Re:This won't be allowed to happen

[ScentCone]

cannabis cures CANCER

Man, the stoners really will pitch any ridiculous meme they can latch on to, won't they?

What a crock

[tomhath]

Imagine, for example, a non-profit entity that would assemble and maintain the IT infrastructure and databases needed to support the entire end to end process, and make it available free of charge,

Sure. Free as in beer. Just imagine it and the billions of dollars and specialized training it takes to develop a new drug just magically appear for free.

Re:What a crock

[tomhath]

Citation? How about you RTFA:

Counting in the costs of failures as well as successes, major pharmas estimate that it takes about $1.5 billion dollars to bring a new drug to market

Re:What a crock

[Antique Geekmeister]

Don't forget the insurance. One mistake, even a purely accidental one or a malicious one from a third party, and the lawsuits can bankrupt such a group in moments. I'm old enough to remember the thalidomide birth defects, and the malicious poisoning of Tylenol. The manufacturers of both drugs were _horrified_ at these tragedies, and did their best to protect the public after the problems were discovered.

Re:What a crock

[tehcyder]

Don't forget the insurance. One mistake, even a purely accidental one or a malicious one from a third party, and the lawsuits can bankrupt such a group in moments. I'm old enough to remember the thalidomide birth defects, and the malicious poisoning of Tylenol. The manufacturers of both drugs were _horrified_ at these tragedies, and did their best to protect the public after the problems were discovered.

The Thalidomide tragedy was caused primarily by inadequte testing. The "horrified" drugs manufacturers spun out compensation claims for decades.

It is a very bad example to use if you're trying to provoke sympathy for big drug companies.

Re:What a crock

[Antique Geekmeister]

I'm not trying to create sympathy for drug manufacturers, but a real understanding of the economic risks for them. I'm noting real risks of drug manufacture. Thorough human testing is very expensive and lengthy, and it's possible to make horrific mistakes that would bankrupt a non-profit very easily.

Re:This won't be allowed to happen

[ScentCone]

I have Chinese neighbours and they're showing me new (to me) stuff all the time

You mean like how grinding up the horn of a rhinoceros and eating it will fix erectile dysfunction because, you know, horns are sort of phallic looking, and if there are only a few of the animals left in the world, it's a sure sign that their horns must be really really effective? Yeah, that's how Chinese medicine operates. It's almost entirely placebo effect, and ... shocking! ... Chinese people die of cancer every day.

Sorry but I'm going to have to cite Dara O'Brian

[Sycraft-fu]

"Oh herbal medicine has been around for thousands of years. Indeed it has and then we tested it all and the stuff that worked became 'medicine' and the rest of it is just a nice bowl of soup and some potpourri."

https://www.youtube.com/watch?...

Your statement about pot curing cancer also has to be one of the stupidest, most easily disproven thoughts I've seen in awhile. Turns out that when people get cancer often they need help managing pain and apatite and marijuana DOES help with those, so a good portion use it. Guess what? They don't get cured. I've had two people close to me who got cancer and died, both who use marijuana to manage symptoms.

You dumbass potheads do more harm to getting it legalized than any of your opponents could by making shit up. The more you lie about what it actually does, how it actually works and the actual risks (yes there are risks, everything has risks) the less people are going to listen to you about the real benefits.

Grow up.

Pharma development is hard and expensive

[hawkeyeMI]

Here's approximately how the drug development process works, to the best of my knowledge. I'm not in pharma but I've discussed some research projects with pharma folks and done a few projects on contract with them. I am not a pharmacologist or chemist. I am involved in medical device development and clinical trials for that purpose.

1. Pick a target condition (based upon need, existing treatments, size of market, whatever)
2. Based upon pharmacology, look at possible pathways to address said condition
3. Develop/find compounds that might address those pathways
4. Do whatever possible to narrow down these compounds by screening for safety before doing any trials, animals or otherwise. Select very carefully for screening techniques that won't give you false dangerous results becuase even if the compound is actually safe in the end, if you have a screen that looks bad at this stage the FDA is not going to like it down the road and it exposes you to liability.
5. Do animal trials with the promising compounds and hope some both work and don't cause harmful effects. Depending on the animal model this can get very expensive and time consuming.
6. Do human trials with promising compounds. A well-powered study will be VERY expensive (easily tens of millions of dollars or more), and depending on the condition being targeted, may also be very time consuming. Hope that what worked in animals works in humans, and no harmful effects crop up.
7. Assuming you make it through FDA approval, and they don't make you do more trials or enroll more patients before you get it, now you can produce the drug.
8. Try to sell enough of the drug to recoup your R&D expenses on ALL the compounds you checked out for the condition, all the trial expenses, etc, before the IP protection expires and the drug goes generic.

This "open source" model is neat and it may help a lot, especially in places where you can get away with less regulatory approval, but the way it's done is not because pharma companies are evil. It's because drug development is hard and expensive, and anything less than a blockbuster drug carries a high risk of never recouping the R&D expenses.

I think there's a lot of hubris to the idea that it can be done so much better this other way, but I will be happy to be proven wrong, because it really is a problem that needs solving.

Re:Pharma development is hard and expensive

[RandCraw]

Nonsense. Why should all pharmas conspire to raise the cost of clinical trials? Why would the FDA agree to this? Why would every other country and their version of 'FDA' play along, when a single dissident would cause such a house of cards to crash instantly?

As it happens, I *do* work at a giant US pharma, so I know how unworkable such a scheme would be.

Re:Pharma development is hard and expensive

[RandCraw]

I do work in pharma, and your sequence of steps sums up the process nicely.

I'd add that for every drug that succeeds, roughly another 20 fail, often after 5 or 10 years of development and costs incurred. That's why the estimated development cost of each new drug is widely acknowledged to be a minimum of $1 billion US (though most cite $2B as the norm). However after you include the cost of all failed drugs, the cost of producing each drug that succeeds effectively rises to between 4 and 5 billion. This is why each new drug needs to be a big selling blockbuster. It has many mouths to feed.

Obviously open software and volunteerism has their work cut out for them if they are to make drugs affordable. But I *would* be curious to know where their advocates believe these forces could have significant impact. It'd have to be in the clinical trial phase, where 80% of cost is incurred.

(BTW, to compute the net average cost of each new drug, you divide pharma company annual R&D budgets by the number of approved drugs/year. Matthew Herper of Forbes has covered this topic extensively, as has pharma chemist chemist Derek Lowe in his blog "In the Pipeline").

Re:Pharma development is hard and expensive

[Ungrounded Lightning]

Obviously open software and volunteerism has their work cut out for them if they are to make drugs affordable. But I *would* be curious to know where their advocates believe these forces could have significant impact. It'd have to be in the clinical trial phase, where 80% of cost is incurred.

For diseases with too small a community of sufferers to pay off that several-billion-dollar price tag, the alternative drug development/deployment system will have to cover all the steps, one way or another, because a pharma company would normally not be able to profitably perform the steps necessary to develop, test, obtain approval, and deploy. a new drug or treatment. Ditto for new uses of existing drugs or common compounds (such as DMSO) that are beyond IP protection. (Even if they COULD get IP protection on a new use, it would be virtually impossible to enforce.)

Big Pharma is out of the loop unless treating an "orphan disease" falls out as an off-label use of something new they've developed for a more pervasive condition, or there's big-time PR to be had.

Once omething like Open Source Pharma is up and running, Big Pharma companies might be able to harvest some PR benefits, and help out sufferers of orphan diseases, by announcing signs they find that some compound might help some particular orphan disease that they can't afford to pursue, and sign off on others proceeding further with it. That could help Open Source Pharma by relieving them of the costs of the initial search for possibilities (and also distract them from competing with the Big Pharma companies on potential new cash-cow drugs.)

Re:Pharma development is hard and expensive

[tmosley]

>He doesn't understand the concept of regulatory capture.

They can hide behind "trying to make the process safe for everyone" any time anyone complains. Human testing really shouldn't be required to bring a drug onto the market. Just label it as "untested on humans" and let the one taking it assume liability (ie it is for people who are close to death or with diseases they consider to be bad enough to take the risk of taking the drug). Phase IV clinical trials are already like this. There are a LOT of good drugs and treatments, even entirely new approaches to curing diseases that are languishing in laboratory freezers because there simply isn't anyone with enough money who is willing to take the risk.

I know because I happened to be a member of a lab that found a new method of directly oxidizing cells or viruses in a targeted way with a catalytic center attached to a peptide created via phage display library targeting. In theory, it could cure all communicable diseases (except prions) and cancer. It's an absolute fucking shame, and every time I hear about someone who died of cancer, I die a little on the inside.

Re:Pharma development is hard and expensive

[clovis]

It's expensive on purpose to make sure only Big Pharma can afford the R&D to begin with.

Big Pharma has the FDA set up expensive hurdles only they can afford to jump.

Nope.
Those rules went into place to make sure as possible that we didn't have another Thalidomide fiasco.

Here's an interesting story about Frances Oldham Kelsey who had the kind of heroic stubbornness that so seldom happens now a days. She and the people she worked with, probably saved the lives of tens of thousands of people from Thalidomide.
http://www.washingtonpost.com/...

And here's some about the big pharma stooges and similar assholes.
http://www.niemanwatchdog.org/...

Re:This won't be allowed to happen

[EETech1]

I know someone that the medical community gave 3 months to live that recovered.

Phoenix Tears

dramatically drive down drug development

[Threni]

Why would anyone want to do that?

If pharma is so hated

[Trachman]

Then their stocks should not be held by Calpers, and other pension funds of public employees. Those, so called, profits earned by Big Pharma first and foremost are used to pay to FDA, and, in essence, compliance with FDA rules. Big Pharma Companies generate dividends, which enrich many of the people who sincerely don't like pharmaceutical companies, while forgetting that Obamacare in essence legalized the monopoly, and monopoly to get the profits, of the very Pharma companies.

TV show

[JeffOwl]

Wasn't there a TV show about open source pharma? I think it starred Bryan Cranston.

Orphan Drugs

[Kohath]

But these companies focus exclusively on drugs that can be sold at high prices to large populations...

This isn't true. Do a Bing search for "orphan drugs".

Orphan drugs:

An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition

Re:This won't be allowed to happen

[JustAnotherOldGuy]

Yep, this is true across large swaths of SE Asia...Cambodia, Vietnam, Laos, etc etc etc. They DO have some actual doctors and Vietnam has some excellent hospitals that do top-notch work, but sadly much of the population believes in magical medicine and "herbal cures" that have no effect (other than as a placebo).

Got a chest pain? "Wear this copper key on a leather thong around your neck for 2 weeks and you'll be cured." That's often the level of "medicine" you'll encounter among neighborhoods both poor and rich.

Oh boy, crowd sourced medicine

[JustAnotherOldGuy]

Crowd sourced medicine and pharmaceuticals, what could possibly go wrong?

I mean, there's no way that spammers and scammers would ever abuse this. They already sell fake penis pills so this whole industry will be a natural for them to invade and infest.

Re:This won't be allowed to happen

[Applehu Akbar]

Investigation of folk botanicals as new soutrces of medicine is routine in pharma and always has been. That's how willow bark tea became aspirin. How many liters of tea would be the equivalent of one 325mg pill, anyway?

Meanwhile, how many endangered species are your Chinese neighbors making disappear in their fruitless search for the elusive senior boner? Viagra saves species that Greenpeace can't be bothered with.

Re: This won't be allowed to happen

[Applehu Akbar]

Undoubtedly from serving time in PMITA prison for selling glass pipes in the first degree.

Re:This won't be allowed to happen

[ScentCone]

Let me guess. That person also works from home and makes $10,000 a month using one simple trick, right?

Re:This won't be allowed to happen

[the gnat]

The Chinese have known about ALL of these things for six thousand fucking years

And the Chinese also had the same god-awfully poor standard of living and short life expectancy as everyone else, until they adopted modern standards of sanitation, public health, and medical care.

not happening

[shentino]

The FDA is in bed with big pharma and will never approve small fry drugs.

Re:This won't be allowed to happen

[tmosley]

Cancer can spontaneously go into remission. Anecdotes aren't evidence. Show me the paper that says that potheads get less cancer, or are more likely to survive it, or have decreased mortality in any way.

Re:Need Cheap Ritalin First

[KGIII]

$0.50/mg on the black market and can (should not) be ingested via IV. Less if you buy in bulk.

LARGER ESTABLISHED CORPORATION

[rawtatoor]

[CAPS]this is about profit? this is about druugs. show me the profit you little pussy. they don't care about gangrene nahmen? gnaa dont mean nothing son -- so when you gonna get that fixed? idiots are gon get stupid ideas like this -- its like this -- when you gon lie? ho? when violence is involved be sure to get paid breaker breaker over over i keep repeating it like this but its a little bitch come get paid you little bitch see you on mars see that thats mission to mars ima make you bite my dick you little hos ima make you see that i'm fresh till the cows come home ima then kill your motherfucking mother with my fresh french bread ima eat breathe live and kill just to make you pay and you owe you fucking owe so come fucking pay and you're just like 'we could lose 21 lines over this' i'd teach you what i just did -- but i'd have to kill you and i don't like you at all this is about HYPNOTISM and i'ma kill you for disrespect c mut i mean na? my shits incorrect like the vainglorious and ima take a to court fur my mom na mean p-nut butta? ima kill ya ma [/ALLCAPS] SUPREME CIVIL WAR --TRUE

Re:LARGER ESTABLISHED CORPORATION

[rawtatoor]

Did you make sure to read it literally so as to check whether my mother is allright?

my mom

[rawtatoor]

my mom banging pots and pans into my left brain. can we do that one? the evil hypmotist

what are we gonna do

[rawtatoor]

they're poking holes in my packages. The whole world knows this shit.

Re:what are we gonna do

[rawtatoor]

The GNAA man.. I ain't even anonymous.

Re:what are we gonna do

[rawtatoor]

Tell me this. What is my model for this. In my brain. What is my model for what is going on?

Re:what are we gonna do

[rawtatoor]

They're the cops but they're selling girl scout cookis. Don't play with my mom son she's got a gun.

Re:what are we gonna do

[rawtatoor]

Then why didn't they do something then? Ho

Re:what are we gonna do

[rawtatoor]

cuz you get paid to read slashdot

Open-source pharma already exists

[Rotaluclac]

Open-source pharma already exists. It's called homeopathy. Though it's still around and amazingly popular, it does not work.

Why should we expect open-source pharma to be different from homeopathy, or from phytotherapy at best?

Re:Open-source pharma already exists

[tehcyder]

Homeopathy, like any other "alternative" medicine (Chinese powdered tiger bollocks, acupuncture, crystal therapy, praying to god) does work, but it's entirely through the placebo effect.

Re:This won't be allowed to happen

[elgatozorbas]

For example, did you know that aspirin is found naturally in willow bark?

This is not such secret knowledge. The chemical name of aspirin, Acetylsalicylic acid even derives from salix alba, the willow.

Re:This won't be allowed to happen

[EETech1]

The person who makes the Phoenix Tears brings in about $50,000 a month and spends most of his time traveling and helping cancer patients. He does not charge them anything, and supports the whole thing out of his pocket.

He has seen it help enough people (starting with his wife) that he has decided it is something he needs to do to help as many people as he can, and it is now his full time job.

Considering he used to spend most of his time on the beach in California, or skiing in Colorado, or on vacation in Hawaii, and he is well past the point where he ever needs to work again, there must be some reason he feels it rewarding enough to come out of retirement.

After 3 of years of doing this he won't say how many people he has helped, he doesn't walk around claiming to have the magical cure, but I have heard from plenty of people he has cared for that they in fact do believe that his care was essential in their battle against cancer.

Cheers

Re:This won't be allowed to happen

[ScentCone]

After 3 of years of doing this he won't say how many people he has helped

Of course not. Quacks selling snake oil really dislike leaving a trail that can be examined by actual people who employ critical thinking and the scientific method to establish the efficacy of drugs.

Re:This won't be allowed to happen

[EETech1]

I believe it is a matter of modesty, not knowing for sure if he was the reason, and being the kind of person who is very confidential by nature.

Most places the extracts are still illegal and fall under manufacturing instead of possession, as well as having harsher penalties. For him to walk around and basically say "I've made and transported enough illegal hemp oil to treat X cancer patients" could have repercussions for his legitimate businesses as well.

He's the kind of person who might be talking to you about your best friend but would never say his name to you out of respect, and the fear of loose lips sinking ships.

Re:This will be stopped

[rs79]

We know why.

Re:Marketing ?

[rs79]

Well said and entirely correct.

Re:This won't be allowed to happen

[ScentCone]

Yes, yes. I man with a miracle cure who could save millions of lives, but he's just too modest to let actual scientists study it or demonstrate its actual efficacy.

So, he'll go down as the Modest Guy Who Let Millions Of People Die Because He's Just So Darn Humble.

Occam's Razor says: quack.

Re:This won't be allowed to happen

[uninformedLuddite]

and the US government has had a patent on cannabis for decades due to its ability to help and heal many different forms of disease. It's easy enough to find the information on this but an old wrinkly drug warrior like yourself probable couldn't give a flying fsck.

Re:This won't be allowed to happen

[pepty]

Did you know that aspirin is actually acetylsalicylic acid (not salicylic acid, which is what is found in willow bark and meadowsweet) and that it was popularized because the salicylic acid in willow bark has much harsher side effects on many people's stomachs?

Re: U wanna kill us all?

[rs79]

Let's talk about how you haven't checkout out any of the claims. Your fallacy is: the argument from ignorance.

Why don't you go count how many times I've been wrong, son. if you can find one thing wrong I'll give you my house. If you can't find anything wrong you give me yours. We on here?

Re:This will be stopped

[Anonymous Cow Ward]

Probably for being off-topic, like the mod category says.