The problem is not finding new antibiotics, it is getting them to market. Given the way the current drug development system has been designed it is very hard to bring a new antibiotic to market and make a profit. Because of this most pharma companies have long ago shut down their antibiotics divisions.
We really need a new approach for funding the development of new antibiotics. My personal favourite is a straight cash reward with a sliding scale for novelty and utility. Just pay the pharma companies a billion dollars in cash for each new antibiotic they bring to market and we will be awash in new antibiotics.
Given the way the current drug development system has been designed it is very hard to bring a new antibiotic to market
It's hard to get any drug to market, and the FDA's intransigence is tragic. Alex Tabarrok has a good book on this called Launching The Innovation Renaissance: A New Path to Bring Smart Ideas to Market Fast (https://www.amazon.com/Launching-Innovation-Renaissance-Brin...).
The FDA is very risk adverse. If they fail to block a dangerous drug and it kills people then they are blamed - if they block a new drug that might save millions of people then nobody says anything. The result is an ever increasing series of barriers to get a new drug to market in the name of preventing a bad drug getting through.
The solution is to hold the FDA (and other regulatory agencies) responsible for all deaths - those that occur from allowing a bad drug to market and those that result from delaying or blocking a good drug. Tort reform would also help as a large amount of the problem is caused by drug companies killing drugs in development themselves because of a fear of getting sued later if anything goes wrong. We also need to be a little more pragmatic as consumers and accept that drugs are risky and will have unexpected outcomes.
Weighing false negatives the same as false positives, disregards the overwhelming predominance of false positives in drug research. Practically speaking, if there were no resistance to releasing new drugs/cures then every quack out there would flood the market. The above suggestion begs to be answered with "Chesterton's Fence". The FDA is acting to solve a real problem.
Accounting for deaths caused by inaction is not the same as weighing false negative the same as false positives. I am not suggesting no regulation, I am suggesting that a death caused by inaction (or extreme caution) is the same a death caused by an action such as mistakenly approving a dangerous drug. Both outcomes should both be considered when making a decision.
Chesterton’s Fence is not appropriate here as we know the reason the FDA fence exists and what problem it is trying to solve. The issue is the FDA is solving the wrong problem (stopping bad drugs getting to market) not trying to minimise human death and suffering.
Stopping bad drugs == reducing human death and suffering. Death thru inaction includes taking worthless drugs that have no proven value. Which would happen pervasively if no fence were erected between proposing a drug and selling it.
The OP said nothing about removing the fence. He advocated holding the FDA responsible for deaths resulting from failure to approve a good drug as well as deaths resulting from approving a bad one. Those are two entirely different things.
Which would be foolishness, as it ignores the incredible suffering and death caused by quackery in fake medicines. Unless that is included in the calculation, then tragedy is inevitable. Loading the dice against the FDA by blaming them for pre-existing suffering could only result in hasty approval. This sounds exactly like 'removing the fence' to me - gutting the FDA to make folks feel like they're reforming something.
You're still arguing against something the OP isn't actually advocating. I see nothing suggesting that "quackery" or "fake medicines" should be approved.
The whole process is to avoid approving medicines that don't work. Shortcutting the process may allow through medicines that don't work. Each time that happens, people die. Its that simple. E.g. My cousin died from a drug that was approved too quickly. He could have used something else and lived.
"The whole process is to avoid approving medicines that don't work. "
No. The process is to identify medicines that are safe and effective. That is not the same thing at all.
Under your viewpoint not approving a medicine that is safe and effective is perfectly fine. Under my viewpoint (and, I strongly suspect, most other people's) not approving a medicine that is safe and effective is a failure. There are ways to avoid that without "shortcutting the process".
The point that is actually being made (but which you seem to be avoiding addressing) is that approving dangerous drugs is bad, and not approving good drugs is also bad.
By that do you mean the trials, safety testing and licensing side of it, or the way drug companies approach new drug development?
I've never quite understood why we can't approach new antibiotics like we have with many enzymes - lab forced evolution. That manages to produce dozens of new ones for food, washing powder and the like, so antibiotic discovery seems like an excellent place to use it.
That doesn't really work unless your antibiotic is going to be a short chain peptide, which might find something but would be extremely unlikely.
Besides, fungi/bacteria have been waging this evolutionary war for a billion years, and we haven't tapped much of anything past beta-lactam (ala penicillin) from that arms race.
The whole regulatory system is not designed with antibiotics in mind. One of the biggest problems is if you bring a new antibiotic to market the doctors will be reluctant to use it as they will want to keep it for those emergency cases when all the other antibiotics don't work. As a pharmaceutical company you have put an enormous amount of money into developing a new drug and them nobody buys it. Rather than go down this path most of the pharma companies have just decided to produce the the things we really need like erectile dysfunction drugs.
is this a problem specific to the US or is it a global problem? I'm aware that US laws make it more expensive to bring a medication to market, but i'm wondering if other less restrictive markets could breed more innovation.
The platform isn't the problem, it's the economic system for drug research. Science and free (copyleft) software are a gift economy, and they have outpaced proprietary software. We recognize that patents are bad in software, open source does better than the profit motive. What's more, it can serve the long tail way better!! While Windows runs on some devices, there are toasters that run Linux. Someone in the world could be Working to add knowledge that can lead to cures for Malaria and the Zika virus, unencumbered by patents. But we'd need prizes.
What would it take for this to become a drug? Well, studies and FDA approval, for one. That takes a lot of money. So how can we raise this money without patents? One way would be government funding, but there is plenty of public funding as well through foundations, etc. What is lacking is a well-developed infrastructure for a growing body of patentleft drugs, the same as software.
"Synthetic route" would be a better description than "platform."
Nevertheless, this is a long, complicated synthetic procedure. It may be simpler than others, but it's much more elaborate than the approaches to many other drugs.
At the end of the day, you end up with a molecule whose pharmacological properties may be very far removed from what you're looking for. These are big, highly functionalized molecules - in other words far from ideal drug candidates.
As others have noted, the biggest hurdles in drug development come late in the process. That's when, after spending hundreds of millions of dollars on Phase 1 and Phase 2 studies, a company finally figures out if they have a drug or not.
Drug development is most decidedly a "waterfall" process. There is no such thing as Agile Drug Discovery, and this paper doesn't really move the goalposts on that front.
We really need a new approach for funding the development of new antibiotics. My personal favourite is a straight cash reward with a sliding scale for novelty and utility. Just pay the pharma companies a billion dollars in cash for each new antibiotic they bring to market and we will be awash in new antibiotics.