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August 19, 2004
Empty Shelves
Posted by Derek
Yesterday I was writing about a proposal to encourage new antibiotics, partly by not putting so much effort into discouraging the use of the current ones. The economist who's advocating this, Paul Rubin, also would like for the FDA to consider accelerating the approval process (and at the very least, not making it even harder than for other classes of drugs.)
I like the sound of that part, as you'd guess, though always with a nervous look up in the sky for the circling silhouettes of the product-liability attorneys, whose razory talons were the subject of yesterday's post. But there's another problem with just stepping out of the way of the new antibiotics: there aren't very many coming through.
Many companies have been scaling back their anti-infectives research over the last few years, and I don't think that the regulatory environment is the main reason. The whole therapeutic area is rather target-poor. We've exploited the obvious vulnerabilities of bacteria, thus the -cillins and -sporins, the fluoroquinolones and the erythromycins. Extended searching hasn't turned up many more modes of attack, at least not of that quality. The most recent new class of antibiotics that I can think of are the oxazolidinones, but resistance to the first one is already showing up.
Here's a rundown of newer antibiotics (the situation hasn't changed much since this appeared.) Note that most of the things on this list have been known for a long time and are being re-examined, or are improved versions of things we already have.
I know where Rubin is coming from - drug resistance wouldn't be as much of a problem if we had a steadier stream of new antibiotics with new mechanisms of action. But I don't know if we can hold up our end. Providing incentives by loosening regulatory requirements could persuade some companies to get into the hunt (or stay in it), but the hunt itself is the real limiting factor. It's not a good situation, and I think that we in the industry are kind of at a loss as to what to do about it. . .
Comments (6)
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1. gary on August 19, 2004 10:12 PM writes...
I think the FDA needs to be careful at passing things too fast without research, yet not to drag their feet since there are helpful medications that need to be released and not kept due to politics!
Permalink to Comment2. Michael on August 20, 2004 2:48 AM writes...
Good points. I'd like to see the FDA revamped to be more efficient in terms of the quality of research and the time required to conduct that research. Good luck, though, revamping a government entity, though.
Permalink to Comment3. John Johnson on August 20, 2004 10:57 AM writes...
People at the FDA are aware of the problems with the quality/speed balance. And they are working on ways of mitigating that. At the same time, there is another player in this: the conservative upper management of pharmaceutical companies. These individuals want, understandably, to do what works or to use proven methodologies because of the other risks involved in drug development. However, a senior officer at the FDA stood before a hundred people at a recent conference saying they are willing and wanting to work with statisticians and executives to employ time-saving techniques in their programs.
The FDA is concerned about the safety, and criticism about placing too much emphasis to the detriment of speed are probably well-founded. However, there is room for improvement from everybody in this area, and I think that companies who view their FDA reviewers as colleagues in research are going to eventually find their drug development times (and costs) shrinking.
Permalink to Comment4. Scott on August 20, 2004 12:33 PM writes...
Check out http://www.idsociety.org/. There is a report titled "Bad Bugs, No Drugs" that is chock full of recommendations on how to increase the number of new, effective antibiotics.
Permalink to Comment5. fin2ut on August 23, 2004 7:46 AM writes...
Once again, you Big Money Corporate types miss the picture in your vapid worship of "Progress". The Indigneous Microbes existed here just fine for billions of years without any help from your Anglo-Hetero-Christo-Suburbo-SUVo so-called Kultur. What you call disease I call the rights of these Indigneous Microbes to peaceful co-existence. In your blind rush to protect your children from "disease", you show grave disrespect to the Earth Mother. I am, however, a pragmatic person, so all I would ask for are some GxP's on petri dish issues. Dr Toot, President, Society for the Advancement of Crash-Test Dummies.
Permalink to Comment6. jeet on August 26, 2004 1:38 PM writes...
I'm curious why combination therapies, a la, HIV therapy, would or wouldn't work. Microbial resistance to one mechanism of action is understandable given the level of infection and rapid mutation and reproduction rates.
Anyways, I'm not sure I would agree with the characterization of "discouraging use of current" antibiotics. To me it seems that it is more along the lines of using antibiotics where appropriate and maintaining full follow-through in an attempt to minimize the emergence of resistant strains.
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