Why New Antibiotics Never Come To Market (vice.com) 345
citadrianne writes: New antibiotics are generated naturally over time by bacteria, as weapons in their ongoing chemical warfare against other microbes. Predicting where and when they can be found relies mostly on good fortune and following a hunch. Scientist Brian Murphy's hunch is that the bacteria which live on freshwater sponges could be a hive of new chemicals. "We don’t know a huge amount about these species," he said. "But the only way to find out if there’s anything there is by actually diving down there and carving them off with a knife." But even if these sponges yield the antibiotics of the future, there are seemingly endless roadblocks that prevent us from actually using them to cure disease. "We've discovered six antibiotics in the recent past," Professor William Fenical said. "Of those, three to four have serious potential as far as we know, including anthramycin. But we have no way to develop them. There are no companies in the United States that care. They're happy to sell existing antibiotics, but they're not interested in researching and developing new ones."
You must choose.... (Score:3, Interesting)
You have billions of dollars, and a business that makes billions more per year.
Do you choose to continue that business and rake in personal rewards like a G5 and an island to fly it to, or do you invest the billions on a risky venture that might pay off some time in the next 10 to 15 years?
Answer from the perspective of a 60 year old with multiple cancers.
Re:You must choose.... (Score:5, Insightful)
This is what happens when you allow sociopaths to run corporations. Sociopaths should, upon discovery, be forceably removed from society at gunpoint and sent to an island together where they can fuck each other, eat each other, or whatever it is these vile neurologically inhuman monsters do to each other. No sociopath should ever have control of even a single normal, empathic human being in even the tiniest way.,
Re:You must choose.... (Score:5, Funny)
This is what happens when you allow sociopaths to run corporations. Sociopaths should, upon discovery, be forceably removed from society at gunpoint and sent to an island together where they can fuck each other, eat each other, or whatever it is these vile neurologically inhuman monsters do to each other. No sociopath should ever have control of even a single normal, empathic human being in even the tiniest way.,
That's a very sociopathic approach to the problem.
Sociopaths are human beings who have what could be considered in a mental illness, in some settings they can be quite dangerous and harmful, in others their illness can even be an asset.
Re: You must choose.... (Score:3)
This.
If GP really wants to outcast people whose only crime is being born with a brain wired in a way that he doesn't like, then perhaps he should move to his own island and appoint himself the Chief of Thought Police.
Anyways, the reason nobody works on these is probably because our existing antibiotics already work really well, likewise it wouldn't be terribly practical to develop more.
I think money and time would be much better spent developing antiviral, antifungal, and anticancer drugs, because all of th
Patent terms (Score:3)
The reason it is so profitable for companies to continue to sell old antibiotics is that the research and marketing is largely done. It' s pure profit with no additional investment. And there is no competition because they are protected by long patent terms.
Patents exist (see Art. 1, Sec 8 of the US Constitution) to encourage science and the arts. Not to encourage profit. The Congress has been bought and they keep extending the length of patent and copyright protections.
So shorten the time that patents
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atents exist (see Art. 1, Sec 8 of the US Constitution) to encourage science and the arts. Not to encourage profit.
That is a very odd statement. Patents encourage science and the arts by protecting profits.
So shorten the time that patents are in effect. When the old antibiotics become public domain there will be a strong incentive for the big rich pharma companies to invest in developing the new ones.
Where is the incentive? If they can still profit selling a branded antibiotic with a generic formula, they will do so. Tylenol is still sold even though you can buy cheaper generic acetaminophen.
The incentive to develop new drugs is only the profits the new drug can make. And shortening patent length on future drugs limits those profits. It won't stop drug development, but it certainly would reduce it. It may still be
Re:Patent terms (Score:5, Insightful)
but protecting profits is a _means_, not an _end_. In this case there is evidence that we're pushing the means to the detriment of the end.
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but protecting profits is a _means_, not an _end_. In this case there is evidence that we're pushing the means to the detriment of the end.
Only if you believe reducing potential profits would help incentivize companies to invest more in drug development. It's not a ridiculous belief, but it is not very intuitive and it has a high barrier of proof. I find it hard to believe that drug companies would poor more money into antibiotics if there was less potential profit in doing so.
And it appears from a quick Google search that all of the antibiotics I had hear of, like Amoxicillin, are already available as generics. So I don't see how patents are
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Where is the incentive? If they can still profit selling a branded antibiotic with a generic formula, they will do so. Tylenol is still sold even though you can buy cheaper generic acetaminophen.
Sure, but in the mean while, they are all trying to develop the next generation blockbuster NSAID,
The profits from patent protection should be just enough to spur more innovation and no more. When you buy a car, do you pay the salesman the least amount he will accept for the car or do you toss in a $20,000 tip?
Re:Patent terms (Score:4, Insightful)
My sister was part of a team that got a patent. The university where she worked shopped around for people that might be able to profit from the patent. Nobody bought it. It sat in the patent office until the patent expired. Now all people that could profit from the patent are free to do so without having to pay the university for the privilege. How do you prevent that from happening again?
Why do you think I am at all inclined to prevent it? They had 17 years to convince someone it was worth having and nobody agreed. Either it just wasn't as useful as they thought or the school wanted too much for it. So, how many are now using the patent without paying?
As for the rest, profit is one thing, but charging over a hundred dollars for a single pill that costs a dime to make is over the top. Gioving people the choice of everything you own or die is over the top. Evergreening and paying people to not compete are plain unethical and should be illegal.
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The reason it is so profitable for companies to continue to sell old antibiotics is that the research and marketing is largely done. It' s pure profit with no additional investment. And there is no competition because they are protected by long patent terms.
I think the patent term is only 17 years or so - and pharmaceuticals tend to have a lengthy approval process, so it ends up being shorter. Basically anything invented in the mid-1990s or earlier is off-patent (with the caveat that use for specific indic
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FDA regulations are, fundamentally, what the US public wants. There's a tradeoff between safety and inexpensive drug testing, and the US public prefers the former. This may not be a completely rational decision (a lot of it was reaction to the thalidomide problems), but I don't think you're going to pick up votes, net, by promising to ease drug approval rules.
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Anyways, the reason nobody works on these is probably because our existing antibiotics already work really well,
If you don't take into account the growing number of things you can't treat with existing antibiotics because the bacteria are developing resistances to them.
We should be working on new antibiotics NOW, not when we can't fight disease anymore.
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Sociopaths would not exist in our society were there not some evolutionary advantage to being an asshole. There clearly is an advantage in some situations and at some level of lack of empathy. But at the same time if that lack of empathy extends too far the advantage becomes a very sharp disadvantage. This has kept the number of sociopaths in society as a certain fixed percentage that's remained relatively stable for a very long time from what they can see in demographic records.
The problem of sequestering
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Sociopaths are human beings who have what could be considered in a mental illness, in some settings they can be quite dangerous and harmful, in others their illness can even be an asset.
Like as CEOs and executioners
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When it comes to running a corporation, being a sociopath is a feature, not a bug.
This, unfortunately, is what late-stage capitalism looks like. To paraphrase Ronald Reagan,
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This is what happens when you allow sociopaths to run corporations.
I'm not sure why the /. crowd gets up and rallies around in defense of sociopaths. It seems to pop up in nearly every political or social converstation that is a trigger for American libertarianism
Maybe because a lot of Slashdotters are tired of clueless idiots treating business and enterprise, core parts of modern society, like an incurable mental illness that needs to be scrubbed from the Earth.
Take your two minute hate [wikipedia.org] somewhere else.
Re:You must choose.... (Score:4, Interesting)
Leaving out the Strum Und Drang for a moment, lets look the TFA. You have this interesting character that runs around and looks for novel biologics. This isn't really breaking new ground - there are thousands of people out in various biomes doing exactly that. Seems like our good prospector has had some success taking a few chemicals and doing some basic research on them with potentially useful results. Kinda neat way to make a living actually.
The article gets more than a little squishy when it talks about the End of the Antibiotic World As We Know It and makes it sound like we're all going to die in a septic heap because of the transgressions of our society. While there is some validity to the 'superbug' hypothesis, it really is only an edge problem. Some people die of multidrug resistant infections, but not many. The antibiotics we have work pretty well.
So, from an economic standpoint, Big Pharma has a point. It costs one hell of a lot of money to take a random, complex molecule and try to make an economic product out of it. Remember, it's pretty easy to get a molecule to destroy a bacterium - Chlorox works great and is rather inexpensive. It's just hard to get a molecule that targets ONLY a bacterium (or cancer cell) and leaves the rest of the organism alone. So this guy has his work cut out for him and has a lot of competition in other "bioprospectors". His business plan is not in it for the long run of taking a molecule from the field to the syringe - he wants to go back out into the field and get more critters to play with. He wants somebody else to do the real grunt work.
Yep, the system could work better but it sounds like this guy needs to start writing a few NSF grants.
Re:You must choose.... (Score:4, Interesting)
"...little funding is available from the public sector.
Twenty-five years ago, the urgent need to find treatments for HIV became a politically charged battleground. Faced with intense pressure to deliver results, the US National Institute of Infectious Diseases became a center entirely dedicated to virology. This remains the case today, but there are now no national programs aimed at tackling drug-resistant bacteria."
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Yes, the HIV scare did run up a lot of money for what is a relatively small problem, but the entire biomedical funding system in the US is at risk for this sort of 'disease of the year' problem. Sure, if we decided to pour a big enough pile of money in this guy's way we would make some progress but this isnt the only field of science that could use more money.
And it's not quite true that the ID institute 'just' funded virology. A lot of scientists shut their mouths and started pounding on typewriters (rem
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In the long run, less political manipulation of scientific goals and more robust, long term funding would help many fields of science
Sounds great in fantasy-land, but you're just not going to get that in reality. So the scientists have to take what they can get, which is the "disease of the year" problem: something gets public attention and everyone starts screaming for the government to fund it, which it does. It's just like space exploration: there was a big political push to land Americans on the Moon
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Have no fear, it won't be long before people start dropping dead of previously curable diseases. There's already a completely untreatable version of tuberculosis that's developed that doesn't respond to a single antibiotic. The state has been going to court and getting forced quarantine orders on the cases they discover. It won't be long before there is a massive outbreak of untreatable TB which will kill enough people to cause this to change.
Re:You must choose.... (Score:5, Interesting)
Roughly 25 years ago, I did work on a system that went to a major drug company. I learned that at that time, it cost roughly $1 billion to get a new drug to market. Of the hundreds of candidates that they would start testing, only 1 or 2 would have the right properties of not killing the patient, not having horrible side effects, etc. And the documentation required by the regulators would fill several semis, because it isn't enough to prove to yourselves that you have a wonder drug, you must prove it to the regulators. This is to prevent Joe's Bait and Pharmacology Shop from putting snake oil on the market. Once on the market, your drug must compete against others. And if those others are in their generic phase, you can express pricing pressure as well.
Then the market for the drug must be assessed. In the case of antibiotics, there are many of them out there, many in generics, so bringing a new one on the market is destined to not sell well...at least as long as too many people aren't dying from super-bugs.
This is a prime area for government research and development. The conservatives and libertarians will whine about the fed. gov. getting into the drug business. However, this is what we expect our government to do, i.e., make up for the shortfalls of private industry. The way I look at it, private industry has a big tote board. When frequency of deaths due to super-bugs rise above a certain level, they'll move. Until then, the conservatives and libertarians will gladly attend your funeral...just kidding, they don't give a flying rat's ass about you.
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Re:You must choose.... (Score:4, Informative)
I only whine when the Feds do all the work, on our dime, yet we end up with a drug company getting all the profits.
This is rarely the case - only 25% of new drugs originate in (presumably federally-funded) academic labs, and even those have to go through a lengthy development process mostly paid for by companies.
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However, this is what we expect our government to do, i.e., make up for the shortfalls of private industry.
I missed that part of the Constitution
Re:You must choose.... (Score:4, Insightful)
It comes under taxing and spending for the general welfare.
Re:You must choose.... (Score:5, Informative)
Pharma business is split into 3 basic areas: Discovery, Development, Commercial.
Discovery: 10k molecules are examined to get to 250 that look promising and down to about 5 to get sent into development. This takes about 5 years. Costs vary wildly. Key concept (among many) here is molecules get thinned down usually because they don't work or aren't safe (Chlorox), but sometimes you just can't manufacture it even if you wanted to make it.
Development: Those 5 are then put through Development which is composed of pre-clincals (tissues and at least 2 species of animals), phase 1, 2a, 2b and 3 trials (human). The patent on the molecule is done early in this process and is good for 20 years. Development lasts about 9 years and costs around US$800m. Key concept here (again out of many) is molecules get dropped off here due to their ADME (absorption, distribution, metabolism, excretion) properties. If you can't deliver the molecule to where it needs to go, it won't work as a drug.
Commercial: Out of Development, there is only about 1 molecule that becomes a drug. You've now spent upwards of US$1b including the cost of failures. The new drug has a patent for around 12 years or so (remember you patented it early in the Development phase). If you don't make that $1b back somehow, you won't be in business very long to develop other drugs. You now have cost of manufacture. This is usually pretty small for small molecule drugs that can be put into a pill, but can be expensive for large molecule (biologic) drugs that are intravenous (think insulin). You also have to collect data and send it to regulatory bodies (phase 4).
So this guy has found a few molecules (one that is hard to get any kind of quantity of from TFA) that are part of the 10k funnel at the beginning of the process. Could be that companies have other compounds that they are exploring that are further in the process. They may be seeing if those fail before starting to look at his. Super-bugs aren't new so companies may have been looking at them already (5 yr Discovery funnel).
And before anyone goes whining about Big Phara, think what you would do if you spent a billion dollars on developing ONE item and had tens (if not hundreds) of thousands of employees that you would like to keep around. How would you decide WHAT to develop and HOW to price it?
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But instead they spend money at cheap, incremental development
Except they don't. Big Pharma has sunk billions of dollars into developing drugs for Alzheimer's, which currently has no truly effective treatments, meaning they have to start from scratch. The failure rate is simply abysmal, so of course we're not seeing those drugs, but it's not for lack of effort.
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If they had a pipeline of research, filled with long-term development of these meds, then they could have a new product every 3-5 years and the argument "it takes too long" goes out the window.
They should hire you since apparently you can deliver and guarantee to continue to deliver a new unique drug every 3-5 years.
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Human biomass is a small part of the ecosystem.
Our food animals outweigh us, by a significant multiple.
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Answer from the perspective of a 60 year old with multiple cancers.
"A society grows great when old men plant trees whose shade they know they shall never sit in." Greek Proverb
~Loyal
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Bullshit. Big Pharma regurgitates generics and those that fall out of patentville. The real research is done by universities around the world.
Only about 25% of new drugs start in university labs; the rest are developed by Big Pharma - or, frequently, the smaller companies they keep buying.
New = Outlandishly Expensive (Score:2)
>> They're happy to sell existing antibiotics, but they're not interested in researching and developing new ones."They're happy to sell existing antibiotics, but they're not interested in researching and developing new ones."
Said a guy who hasn't been paying attention to the way drugs get developed in the US? (New drugs can be patented and sold for outrageous amounts of money.) Or maybe the professor just needs to switch to a different university that knows how to monetize his work.
Besides, isn't t
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Because drugs have been patented and sold for obscene piles of money, the regulatory environment has "stepped up their game," in requiring newer drugs to prove their safety and efficacy with obscenely expensive testing protocols before coming to market. Not only does this "protect the public," it also happens to protect the income stream of those who are selling the current crop of drugs, so it's a very strongly enforced agenda.
Mr. sponge diver is frustrated because he knows about a chemical which he suspe
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Because drugs have been patented and sold for obscene piles of money, the regulatory environment has "stepped up their game," in requiring newer drugs to prove their safety and efficacy with obscenely expensive testing protocols before coming to market.
The failure rate for Phase III clinical trials is somewhere between 25% and 50% - i.e. over half of the drugs that make it through Phases I and II are still not effective enough for regulatory approval. We can therefore reasonably assume that if we get rid o
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>> They're happy to sell existing antibiotics, but they're not interested in researching and developing new ones."They're happy to sell existing antibiotics, but they're not interested in researching and developing new ones."
Said a guy who hasn't been paying attention to the way drugs get developed in the US? (New drugs can be patented and sold for outrageous amounts of money.) Or maybe the professor just needs to switch to a different university that knows how to monetize his work.
Besides, isn't the market for antibiotics shrinking now that they are no longer routinely prescribed for minor ailments?
A new, super expensive antibiotic would be prescribed very rarely -- only in cases where such a special antibiotic were truly necessary. Even if you charge $2,000 a dose, you still need to sell a million doses to make back the two billion dollars it took to develop and test the drug.
Even if you sell it cheaply, it can take years before it becomes commonplace since it's still a new and untested treatment, so well known alternatives will be tried first, and you have limited time to earn back the development c
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thanks to our government and the nightmares they make companies endure to get to that point
As opposed to letting them put out whatever shit they think they can get away with? That doesn't exactly sound like a good idea either.
Re: New = Outlandishly Expensive (Score:3)
of course not - same way people look for a UL sticker on their toaster, they have a very strong incentive to prefer safe drugs (as does the prescribing physician).
Even on net (risks of going too soon vs. too late) estimates are that the FDA process is responsible for twenty million excess deaths:
http://isil.org/death-by-regul... [isil.org]
That number could multiply significantly if we get a resistant superbug. No good person supports such an deadly system.
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thanks to our government and the nightmares they make companies endure to get to that point
As opposed to letting them put out whatever shit they think they can get away with? That doesn't exactly sound like a good idea either.
If only the human brain was capable of easily identifying false dichotomies. Then you wouldn't see comments like this, since everyone would easily identify how poor of an argument they are.
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The market isn't shrinking at all.
The over prescription of the current antibiotics has lead to resistant bacteria. If this keeps up we will be catapulted 100 years back to when a routine surgery would likely kill you due to infection that cant be treated with anything but amputation.
Will you fucking shut up and take your medication. Look around you, how many people run out of hospitals dissolving in protoplasmic goo because of untreated bacterial infection? Yes it's a problem. Not an especially big one, actually.
Rampant, unrestrained paranoia is another, bigger problem.
Turn OFF the TV.
Sounds like an argument for government research (Score:3)
The dwindling effectiveness of antibiotics is a public safety issue. No big company is going to want to take the hit and invest millions of dollars into developing new antibiotics when the return is likely to be a long way off and isn't guaranteed at all. For things like this, it makes sense to use tax money to fund research and then contract companies to develop medicines (or, god forbid, just build some government facilities to develop and produce them there).
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I would think this is an obvious approach. Of course this is a public issue - and one that is extremely unprofitable for private corporations to tackle. But I don't understand - is the average American opposed to government funded research into antibiotics? If so, why?
Of course not (Score:5, Interesting)
The pharmaceutical companies aren't interested in developing inexpensive drugs you take a few times and then are done with. They want to develop something you have to take for the rest of your life to treat a chronic condition and charge as much as they can get away with. That's why both new antibiotics and new vaccines are seldom developed.
Americans pay far more for their prescription drugs than the rest of the world and the excuse is that we're funding "innovation". Most of the innovation going on seems to be coming up with slight variations of existing drugs in order to extend the copyright and doing their best to delay a generic version of a drug from being marketed.
Even when a generic version of a drug appears, greed is often in play. Just a month or two again, this was in the news "The rights to Daraprim were purchased in August by a new company, Turing Pharmaceuticals, which promptly increased the price from $13.50 per tablet to $750 per tablet -- a 5,000 percent jump -- the New York Times reported."
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I've seen plenty of new vaccines developed, the one that comes to mind at the moment is HPV - in 2000, HPV was just a nuisance that women got regular pap smears for, then cervical resurfacing when they came up positive with "precancerous lesions." We asked "What about HPV testing" when presented with a "just cut a loop around the cervix, it might mean you won't be able to carry a child to term, but it will prevent cancer" diagnosis in 2000, and were told "oh, that's all theoretical stuff, you can get teste
Re:Of course not (Score:4, Insightful)
Except "2005" was actually February 2007, "legally required" was an executive order issued by then-Governor Rick Perry ("individual liberty-R-us"), and the Texas legislature promptly overrode the executive order in June 2007 so that there never was any "legally required" vaccination for school attendance.
Moderated to +4 informative, yet almost completely wrong on the objectively veribiable information. I think I'll disregard your HPV treatment anecdote as well...
Re:Of course not (Score:5, Insightful)
And the HPV vaccine came from Australian public reseach dollars, $$$$ pharma.
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Meant to type and NOT $$$$ pharma. In 2015 /. Still can't do editing.
Or perhaps... (Score:2)
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Even when a generic version of a drug appears, greed is often in play. Just a month or two again, this was in the news "The rights to Daraprim were purchased in August by a new company, Turing Pharmaceuticals, which promptly increased the price from $13.50 per tablet to $750 per tablet -- a 5,000 percent jump -- the New York Times reported."
Followed by another company that is selling the pill for less than a dollar per pill. But that's not as sensational, is it?
http://science.slashdot.org/story/15/10/25/1420259/drug-firm-offers-1-version-of-750-daraprim-pill [slashdot.org]
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After reading the details, the second company is producing "custom" formulations for individual patients that should behave the same as the original FDA approved drug, but are not exactly the same and are not themselves FDA approved. My impression is that they're tweaking the recipe in an attempt to not get sued.
If the resulting drug(s) provides the same benefits as the original, I'd say more power to them.
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inexpensive drugs you take a few times and then are done with
For most conditions these are simply a fantasy. There are very few true "cures" in medicine, only varying degrees of palliatives. The idea that we'd all be living cancer-free to 150 years if only Big Pharma would focus on real cures is absolute nonsense, because it's extraordinarily difficult to make a drug that magically eradicates all traces of an ailment without severely damaging the host. People who think otherwise need to take a few biolog
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Actually it does not. It removes the "feeling ill" perception ... but enough bacteria survive to develop resistance.
Especially if you indeed "a drug you take a few times and then are done with" instead of following the prescription and the text on the paper in the box: take all pills!!!
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"Americans pay far more for their prescription drugs than the rest of the world"
I'm assuming you mean individual Americans....wouldn't someone in Europe end-up paying the same amount for the drug as well? What I mean is that someone is paying for the drug, whether it's individual citizens or the government health insurance programs. Wouldn't antibiotics be the same everywhere regardless of who pays for it (currency exchange rates aside)?
Re:Of course not (Score:4, Informative)
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Economies of scale...
A national healthcare system has a lot more buying power than a small independent hospital, and drug companies cannot afford to lose such large customers.
I'm confused (Score:5, Interesting)
And the rest of the world? (Score:2)
But we have no way to develop them. There are no companies in the United States that care.
And is the rest of the world the same? It is bigger than the United States, y'know.
Re:And the rest of the world? (Score:4, Interesting)
And is the rest of the world the same? It is bigger than the United States, y'know.
Sure, there is plenty of other land mass but they are either over-regulated, poor, or have low quality research infrastructures. The majority of all new drugs come out of research from the United States and that trend has only increased over the last forty years. That doesn't mean everything is happy days here, excessive market consolidation has reduced the number of new substances produced by more than 60%.
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Perhaps you need something for your shaky-leg-syndrome then.
Cheap drugs (Score:2)
The rest of the world wants the US pharmaceutical companies to develop the new drugs so they can be sold in the US at a high price and dumped elsewhere.
It wouldn't be right for people in other countries to bear the actual cost of developing the drugs they use.
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What, it's impossible for a pharma company to start up outside the USA?
Your assumption is that it's only the evil of the US pharma companies that are keeping new antibiotics and such from being developed. If that were true, then it should be relatively easy to come up with startup money to do a pharma company in, say, Europe (or China, or India) that could just rake in the money while charging a fraction as much as American companies do.
So, why hasn't it happened? And why haven't YOU started one up if
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Just off the top of my head, Bayer, Roche, Novartis, GSK, AstraZeneca, Sanofi-Aventis are all European companies. (They do also have US sites, of course.)
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No, all of these companies started in Europe. Of course they've expanded massively and bought up companies in the US, some of them relatively large - Roche swallowed Genentech whole, which was already a large and well-established (and very profitable) business. But Roche itself is a Swiss company. The one trying to do tax inversion is Pfizer, which is indeed a US company (that tried and failed to buy AstraZeneca recently - I forget who they're trying this with now).
This is why.. (Score:4)
basic/pure research is done through government funding of some form.
Much to the chagrin of the free market zealots.
Drug companies spend more on marketing than they do on R&D.
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Exactly. Something like 50% of new drugs are developed by research at universities - funded by our tax dollars - and they turn around and sell the rights to a pharma company who then charges us a high price for that drug that we already subsidized the development of.
I've read about this happening and there should be more control over the rights to the results of public research.
I know the argument always given is that someone has to produce the actual products of the research and the pharma company is already equipped to do so.. but the margins on those products should certainly be very limited for the public good.
Re:This is why.. (Score:4, Insightful)
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Incorrect. It's more like 25% at most, and the part that your tax dollars pay for is the research, not the development, which is typically paid for by the company.
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Re: This is why.. (Score:2)
Commercials? How retro.
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Marketing has bigger, and much faster, ROI than R&D.
I worked for a grant funded company once, the federal grants paid us for 6 months to develop the product, then they paid us for another 18 months to develop and prosecute the FDA submission for permission to market the product. We got our permission to market, but the federal grants didn't pay for marketing, so the product ultimately fizzled.
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I talked to a doctor about this one (Score:5, Interesting)
Note this only applies to antibiotics......if there were a drug curing malaria or AIDS, it would be a different story.
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Yup, unless there is a massive outbreak of resistant bacteria that only the new antibiotic will treat.. it will never get used. After 17 years you will lose exclusivity to make the drug. Sounds like a huge risk.
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There's another problem, which you could call 'Life finds a way'.
Penicillin was discovered in 1943 but it was only 3 years before the first resistance was observed. The same thing has happened to nearly every antibiotic developed since then [nature.com], with resistance usually appearing within a few years - a constant game of whack-a-mole.
It takes 10 years and a billion dollars to bring a new drug to market, there is little profit incentive to develop a product which has a potentially short and unquantifiable lifetime.
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This is *exactly* the problem, and is why constant government-funded work bringing new antibiotics to market should be the norm.
The problem you are talking about is one of resource allocation. The reality is we can't fund all the research and all the studies and all the science we want to. Generally, we look at the free market as a signal mechanism: if people aren't willing to pay for a drug, they probably don't want it.
So the question for you is: why do you think government regulators will be able to do a better job allocating resources than the free market? Bonus points if your answer shows you've actually thought about the issu
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Because of the Prisoner's dilemma. This is basic game theory, and not some astounding revelation.
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Because of the Prisoner's dilemma. This is basic game theory, and not some astounding revelation.
If you want to make an argument based on "basic game theory" you need to show that it applies in this situation, and that government regulators would do a better job allocating resources overall.
Based on your comment, you haven't thought about this situation deeply, and are only capable of facile responses on the topic.
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Most people reading my response and who know what the prisoner's dilemma is, would immediately know what I mean. As such, I gain zero benefit from taking the considerable effort of explaining how it applies to this scenario specifically for you.
Maybe if you were to pay me for my time, I can educate you on the subject. Otherwise, it's not worth it. If that's unsatisfying to you, well...such is life.
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Maybe if you were to pay me for my time, I can educate you on the subject.
Give me an address and I'll send you a check.
I already owe you one, after all, for you comedian skills. Your response there gave me a good laugh.
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You have failed to answer the question why the US needs to do that. Supposedly, the oh-so-more-"socialist", wealthy, and rational European nations could do that. Yet they don't.
The amount of innovation in US health care is pitiful compared to what it could be. We have th
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as for AIDS, the current drugs are very high profit and keep the patient hooked for a very very long time. Actually curing the disease would be cutting their profits.
The clear evidence against your point here is that companies are paying a lot to cure AIDS. An explanation would be that although it might cut profits for the industry overall, it would also give huge profits to the company that actually found a cure.
Patents are not working (Score:2)
Slanted PoV (Score:3)
Good news actually (Score:2)
We need to learn to stop using non-renewable medical assets to create more beef before we license them for sale.
Otherwise, we will just be putting off the coming resistant-strain disaster by months, rather than decades.
Need to get rid of proving drugs are safe (Score:4, Interesting)
The burden in drug companies is too high. Biology is too complex. If peanuts were a drug they wouldn't get approved because too many people have bad reactions, but they are perfectly safe for others.
All a drug company should need to do is disclose what the drug contains and be liable for fraud if it deviates from this.
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I just can't imagine what could go wrong here....
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Isn't this a role of government? (Score:2)
Resistance develops too quickly to make money (Score:3)
New radiolap is about this
http://www.radiolab.org/story/... [radiolab.org]
last antibiotics that got into market developed resistance in 2 years, so commercial companies don't want to deal with this
otoh at least this podcast gives hope (similar to article) that we just have to rotate the antibiotics we have :)
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This is why we need to vote in a government that does care. Otherwise nothing will happen. The choice is ours.
What, Twilight Sparkle for President?
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Because of so many logical flaws, it's mind boggling.
If it is important to bypass the gut, use an injection. ... leading to higher chance of resistance.
The gut wall is permeable. those metabolites will be in the gut anyways. But in lower concentration
Metabolism is all over the map. Trying to figure out the pharmakinetics of such a drug to achieve proper dosage would be a nightmare.
And finally, it's tough enough finding a drug. Finding a drug that can be created by a metabolic pathway is tough squared.
Ye
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That's not the solution. The solution is to keep the new antibiotics in reserve and only use then when absolutely necessary, and then be absolutely sure they are used correctly. Most of the problem is giving people a new drug when their particular infection could be treated by an older drug, or not giving them enough of the drug, or not giving it to them long enough. The Centers for Disease Control are all over this problem but it will take a while to ch