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Why New Antibiotics Never Come To Market (vice.com)
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."
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.,
The world's burning. Moped Jesus spotted on I50. Details at 11.
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.
I stole this Sig
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."
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.
Faster! Faster! Faster would be better!
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.
I talked to a doctor about new antibiotics. The problem is you won't make your money back from them. A company has to go through all the trials to prove that the new antibiotic is safe, and than enough people need to buy them to make it worth it. In the case of antibiotics, there are so many already on the market that doctors won't use the new antibiotic, they'll just use existing ones.
Note this only applies to antibiotics......if there were a drug curing malaria or AIDS, it would be a different story.
"First they came for the slanderers and i said nothing."
Reading comprehension isn't your strong point.
"...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."
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.
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%.
I worked in the pharma industry for a bit so let's look at some numbers:
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?
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.
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.
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.
I love Jesus, except for his foreign policy.
I keep hearing about how there are no new antibiotics, but I never really looked into it. A quick gooble search found 36 new antibiotics currently in development. Some of them are combinations of existing antibiotics (a promising but not very innovative approach) and some of them are new molecules.
Man, you really need that seminar!
It comes under taxing and spending for the general welfare.
"When you have eliminated the unacceptable, whatever is left, however improbable, must be the truthiness" - Holmes
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.