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."
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.
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).
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."
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."
When patents fail to encourage innovation they need to be changed. Overly long IP rights terms on just about everything is harming American innovation in just about every way possible.
If video games influenced behavior the Pac Man generation would be eating pills and running away from their problems.
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.
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%.
The article complains that "Despite their best attempts, they were unable to collect enough species (Diazona angulata) to obtain sufficient amounts of the precious chemical.". However this article omits a significant detail: a biologically active analog of diazonamide A was synthesized in 2003 AND he is listed as one of the authors. http://www.ncbi.nlm.nih.gov/pu....
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 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.
"He took a duck in the face at 250 knots." -- William Gibson, Pattern Recognition
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 of Phase III trials altogether to save Big Pharma some money, half of all new drugs will actually be useless. (Except it'll probably be even worse, because without the risk of Phase III failures - which are the worst nightmare of any sane pharma CEO - they will have less incentive to discard more marginal candidates.)
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.
Yeah, you're going to lose money.
The world is made by those who show up for the job.
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...
That number could multiply significantly if we get a resistant superbug. No good person supports such an deadly system.
My God, it's Full of Source!
OUTSIDE_IP=$(dig +short my.ip @outsideip.net)
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 change behavior.
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!
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 the biggest public health care system in the world (both in absolute terms and per capita), with the spending of the remaining private system massively regulated. And both public and private systems redirect money towards highly profitable but mostly useless interventions, because that's what health care providers, insurance companies, and pharmaceutical lobby for. The only saving grace of our health care system is that others are even worse. But increasing government health care spending takes us in exactly the wrong direction.
New radiolap is about this
http://www.radiolab.org/story/...
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 :)
Drug companies are in 'health' for the money rather than benefits to humanity.
More news after the break.
Requiem for the American Dream