What Is Open Source Pharma (and Why Should You Care)? 165
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.
malaria is not negected (Score:2)
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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... [wsj.com]
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 d
There's more to it than developing the drugs. (Score:2)
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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
Re:There's more to it than developing the drugs. (Score:5, Insightful)
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#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 retir
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#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.
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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.
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Hey, psychopath dude there is a world of difference between 10% profit and predatory margins of 10,000%, I know you always have to be reminded because you can not see beyond your own ego.
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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.
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You only live those 40 years if you happen to be rich enough to afford it.
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I find you dying in the desert so I drive up in my water tanker (filled to capacity) and sell you just enough water to keep you alive in return for everything you own and a promissory note for the rest. Seem fair?
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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?
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OH, you're a KOOK! You should have said so and saved me the trouble of replying.
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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. (Score:2)
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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 insura
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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.
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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.
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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.)
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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.
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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 no
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Re:There's more to it than developing the drugs. (Score:4, Interesting)
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 [forbes.com], 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. (Score:4, Informative)
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.
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1. Your first paragraph doesn't inform your second paragraph at all.
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Two separate thoughts in two separate paragraphs. Where's the confusion?
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Here's one. [ipa.org.au]
Re:There's more to it than developing the drugs. (Score:4, Insightful)
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.
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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.
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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.
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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 gon
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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
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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 wil
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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?
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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 reci
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Crap crap crap (Score:2, Troll)
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.
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OK. But we need new pharmaceuticals to treat our open sores.
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[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... (Score:1)
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.
LARGER ESTABLISHED CORPORATION (Score:1)
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my mom (Score:1)
Maybe find a cure for cancer and more (Score:1)
Actually no (Score:3, Informative)
Re:Actually no (Score:5, Informative)
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.
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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.
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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 - cli
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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 pl
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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.
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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.
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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
What a crock (Score:2)
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.
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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.
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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.
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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.
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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
Pharma development is hard and expensive (Score:5, Informative)
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.
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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.
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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.
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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
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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/... [washingtonpost.com]
And here's some about the big pharma stooges and similar assholes.
http://www.niemanwatchdog.org/... [niemanwatchdog.org]
Re:Pharma development is hard and expensive (Score:4, Informative)
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").
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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 p
dramatically drive down drug development (Score:1)
Why would anyone want to do that?
If pharma is so hated (Score:2)
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 (Score:2)
Orphan Drugs (Score:2)
This isn't true. Do a Bing search for "orphan drugs".
Orphan drugs [wikipedia.org]:
Oh boy, crowd sourced medicine (Score:2)
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.
not happening (Score:2)
The FDA is in bed with big pharma and will never approve small fry drugs.
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TPP will have no teeth as long as BRICS is allowed to continue.
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We know why.
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cannabis cures CANCER
Man, the stoners really will pitch any ridiculous meme they can latch on to, won't they?
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I know someone that the medical community gave 3 months to live that recovered.
Phoenix Tears
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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 Ha
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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.
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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
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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.
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Re:This won't be allowed to happen (Score:5, Insightful)
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.
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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
Sorry but I'm going to have to cite Dara O'Brian (Score:5, Insightful)
"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?... [youtube.com]
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.
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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.
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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.
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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.
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Undoubtedly from serving time in PMITA prison for selling glass pipes in the first degree.
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$0.50/mg on the black market and can (should not) be ingested via IV. Less if you buy in bulk.
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Well said and entirely correct.
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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?