Not sure why this was down voted because it's true. Only a few big pharma have R&D programs in the antibacterial space. As a reply above states, the current system penalizes new antibiotics by reserving them for only the most severe cases. With the cost of a new antibiotic approval in the hundreds of millions of dollars, companies put their R&D dollars into areas with better returns.
That being said, a few new legislative changes have happened and will happens (GAIN Act approved, DISARM Act being considered) that will change the economics of antibiotic research and have already prompted drug companies to get back into the field.
Another big reason is the lack of financial incentives for companies. A lot of new antibiotics are for very small populations (you'll only use a new antibiotics for the rare cases of drug resistance).
As a result, drug companies are looking at spending $100M to make a new drug, when they'd be lucky to make their money back on it.
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.
You're not going to have new antibiotics without biotech or pharmaceutical companies helping.
The government needs to provide incentive for antibiotic research, right now regulatory and reimbursement issues are making the therapeutic area very unattractive.
The problem developing new antibiotics is not the science it is economic and regulatory. Let's say you are crazy enough to pay the enormous cost of bring a new antibiotic through the regulatory process, your new antibiotic doesn't get used by doctors. They put the new antibiotic on the shelf to be used in emergencies when all the other antibiotics haven't worked. Your sales are then near zero. This is why all the major pharmaceutical companies have shut down their antibiotic divisions.
What we need to work towards is a large cash payment on approval of each drug or a guaranteed minimium annual payment. Once we have this we will start to get the new antibiotics we need.
There was an interesting piece on BBC radio 4 a few months ago looking at the problems with the market when it comes to developing new antibiotics and I suspect government intervention will be needed to help the market along.
The usual model of drug development is
Spot opportunity > spend lots on R&D > Go into production > maximise sales > recoup money as soon as possible > Profit!
However, with new antibiotics we, as society absolutely do not want them to maximise sales. Ideally we don't want any production at all. At worst, we'd like it to be used in a handful of cases for 5, 10 or 20 years, keeping it as a treatment of last resource.
In such circumstances you can see the problem for the pharmaceuticals. Personally, I think there needs to be some kind of prize fund that can let the companies recoup (and make a decent profit) from antibiotic discoveries. Either that or public-sector research.
New antibiotics are high on the list of things that are needed, but they will only be used as treatment of last resort, this is where the traditional investment model fails. Development is too expensive to ever recover the outlays.
Right now science can't do anything about the high failure rates in Phase II and Phase III trials. The problem isn't to come up with a compound against your target of choice, it's that apart from clinical trials we don't have a way to predict if in real life it will perform better than placebo (Phase II) or adequately (Phase III).
This is actually completely right. I believe there's some policy in the works in the US after talking to a friend who's doing some consulting work to help align the Cost-Benefit side of antimicrobial development.
I can't say if there's a plethora of drugs just waiting to be released after CT requirements are lowered, but definitely there is less of an R&D incentive currently because pts who take antimicrobials only take them temporarily and cases where you need an advanced antimicrobial to deal with an AMR case are thankfully uncommon.
The problem is this is kind of a catch-22 for drug companies. If they only release a new antibiotic in IV form, meaning it will only be administered at hospitals, they don't get enough volume to make money. So why research the next one?
In general I'm a pretty free-market guy, but this is one area I'd like to see the government more involved, both in subsidizing new antibiotic development and in making sure we have a stock of antibiotics that still work.
Based on the seriousness of the infection being targeted, the FDA is creating accelerated approval pathways. There has already been some discussion about guaranteeing a certain amount of profit for the pharmaceutical company once it hits the market.
I don't know if there is plenty of money to be made on the development of antibiotics, but I do know that the heads of all the big pharmaceutical companies don't think there is.
More regulation preventing the use of antibiotics won't encourage pharmaceutical companies to invest in this area, only making developing antibiotics more profitable will. This can be done in three way:
1. Encourage use of the new antibiotics so they sell more.
2. Increase the price.
3. Pay the companies directly for developing a new antibiotic (X-Prize-like approach).
My personal opinion is that option 3 is the best way, but right now there is no mechanism for doing this on anything other than a toy-scale. What won't encourage pharmaceutical companies to invest in the development of new antibiotics is to restrict their sales and increase their costs via regulation.
If you seriously believe the reason we don't have new class of antibiotics is because of the pharmas are not interested enough in making one, you don't know what you are talking about.
You know why we cannot find new antibiotics class? Because it is hard, really really hard! Your statement about economics being the main drive of finding new cures, including antibiotics, is a great insult to tens of thousands of researchers working hard day to day with the sole purpose of find that damn compound. Yeah, these researchers are human with lots of feelings and sometimes with friends and families needing new treatment too, and they are not just working for the salary or bonus.
Patent system is not perfect, but getting rid of patent system will not speed up or better incentivize any effort of finding new drugs and cure. Think more public funding in basic research in universities, and new/better way of regulation/approval instead.
> Venture capitalists are investing far less funds to develop new antibiotics than they are for oncology drugs, according to a new report that highlights the need for more financial incentives to fight off the growing threat of drug-resistant bacteria.
> The report, published Monday by the Biotechnology Innovation Organization, found that investors are increasingly shying away from antibiotic research due in part to large companies exiting the space. That’s left small companies, that typically rely on investment capital, struggling to carry out new clinical trials.
> Newer antibiotics are more important than ever as the Covid-19 pandemic has forced people into hospitals for longer periods of time, increasing the chances for the spread of antibiotic-resistant germs, the biotech trade group said.
> But in the past 10 years, venture capital funding for U.S. antibiotic development amounted to $1.6 billion, compared to $26.5 billion for oncology, according to Monday’s report. The group noted that there are currently 64 new antibacterial therapeutics in the clinical trial pipeline, 80% of which originated from small companies.
You're right about incentives being wrong, but I disagree with the preference for chronic drugs being a primary factor. In my opinion, the primary incentive killer is that agencies like the FDA will not approve a truly new antibiotic for general use. It gets approved as an antibiotic of last resort. So for the time that a new antibiotic is under patent protection, the company can't recoup their R&D because they can only address a tiny part of the market. When the day finally comes when the wonder drug can be standard of care, it's well off patent and generic competition torpedoes any real profit. Why develop a great new antibiotic if the FDA forces you to keep it locked away? From the company perspective it makes no sense.
You're right about incentives being wrong, but I disagree with the preference for chronic drugs being a primary factor. In my opinion, the primary incentive killer is that agencies like the FDA will not approve a truly new antibiotic for general use. It gets approved as an antibiotic of last resort. So for the time that a new antibiotic is under patent protection, the company can't recoup their R&D because they can only address a tiny part of the market. When the day finally comes when the wonder drug can be standard of care, it's well off patent and generic competition torpedoes any real profit. Why develop a great new antibiotic if the FDA forces you to keep it locked away? From the company perspective it makes no sense.
They do this to a certain extent, but the problem here is that the "R" part of "R&D" is not really at issue. While there's a lot of focus in the popular press on "finding" new antibiotics, that part can be addressed by basic research grants. I don't believe we're wanting for proof of concept kinds of things. Unlike with engineering, where once you've got a proof of concept, you can refine and iterate to make it production quality, biology is completely arbitrary.
The issue comes with the "D" part of R&D. That is the expensive part with drugs because you start having to do very tightly controlled animal model studies progressing further into clinical trials with humans. The popular notion that you "discover" a drug is not how things work in reality. Often you discover a whole raft of closely related chemical entities that appear to do what you think they do. You tweak based on further studies in order to improve efficacy and safety. But the system is sort of nondeterministic in the sense that even altering the structure slightly often has knock-on effects you can't predict. Assuming you get something decent, that's what gets made into the an actual medicine. There's a whole branch of applied chemistry that specializes in this called medicinal chemistry. In many cases, you'll read about some promising new antibiotic that has been discovered in an academic lab, but once the chemists take a look at it, you realize there's no way to make a drug out of it. The reasons can be any or all of: the therapeutic dose would be too high, it blows out the liver, it can't be made into pill, the compound is unstable and can't have a good shelf life, it can't be taken orally, etc... Working out all those kinds of problems has always been the realm of pharmas and biotech startups. Academics aren't interested in that stuff because it's not basic research, it's highly applied and is mostly trial and error based on decades of doing this kind of work.
At a macro-level, this is fundamentally what ails the entire pharma sector right now. The development part of making drugs is so expensive and such a complete and utter crap-shoot, that few new drugs of any sort are actually being produced. The last decade has been one of prolonged decline in the industry in terms of truly new drugs and there is no obvious mechanism available to us to make it less so.
The current regulations are setup so that it costs a mountain of money to make an antibiotic and you can only make a molehill of money. That seems like regulating the R&D away.
Of course what you want is antibiotics to cost a dollar and be as safe as apply pie and as plentiful as salt water. But that's not really an options. Our options are the status quo, heavily subsidize antibiotic research and pricing, reduce regulations so they can be developed incredibly cheaply, or change regulations to drive up sales.
The ROI on antibiotics is much lower than that of a "lifetime drug" such as an anti-depressant that a patient will take for years and years. Pharmaceuticals are mostly privatized and that's not changing, so the government is going to have to find some ways to incentivize innovation in the antibiotics market. Counting on government isn't a popular option these days, but this is the perfect role for them actually.
That being said, a few new legislative changes have happened and will happens (GAIN Act approved, DISARM Act being considered) that will change the economics of antibiotic research and have already prompted drug companies to get back into the field.
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