4 ms·

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

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.

anexprogrammer 10y ago
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.
- chris_va 10y ago
  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.
- danieltillett 10y ago
  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.
jseliger 10y ago
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-Bring-Market-ebook/dp/B006C1HX24 https://www.amazon.com/Launching-Innovation-Renaissance-Brin...).
- danieltillett 10y ago
  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.
  - JoeAltmaier 10y ago
    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.
    - danieltillett 10y ago
      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.
hayksaakian 10y ago
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.
- danieltillett 10y ago
  Both in a way. Most pharma companies make most of their profit in the USA. The USA has a lot of power over what drugs are developed or not.

anexprogrammer 10y ago

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.

chris_va 10y ago
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.
danieltillett 10y ago
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.

jseliger 10y ago

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-Bring-Market-ebook/dp/B006C1HX24 https://www.amazon.com/Launching-Innovation-Renaissance-Brin...).

danieltillett 10y ago
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.
- JoeAltmaier 10y ago
  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.
  - danieltillett 10y ago
    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.

hayksaakian 10y ago

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.

danieltillett 10y ago
Both in a way. Most pharma companies make most of their profit in the USA. The USA has a lot of power over what drugs are developed or not.