Novartis dumps antibiotic research

​​As mentioned in prior blogs, there are increasing numbers of increasingly antibiotic-resistant microbes. And, compounding this problem, is the hesitance of drug companies to develop new antibiotics, since these are much less profitable than drugs for chronic diseases (they tend to be prescribed for a limited time course, and typically after routine antibiotics have been tried)

In this light, it is disturbing that Novartis AG has just announced that they are stopping their antibiotic development program, including stopping development of some very promising new antibiotics that are at later stages of development. (see http://www.cidrap.umn.edu/news-perspective/2018/07/novartis-drops-antibiotic-development-program ). (thanks again to Paul Susman for bringing this to my attention)

Details:
-- Novartis was one of a few large drug companies doing active research and development for new antibacterial and antiviral drugs
-- they were a signer of the Davos Declaration in 2016, “a written commitment by more than 70 pharmaceutical and biotech companies to invest in research and development of innovative treatments and diagnostics to combat antibiotic-resistant bacteria”
-- Novartis had 32 antimicrobial projects ongoing, 7 of which were in the clinical stage, including one targeting C. difficile and another one against carbapenem-resistant Enterobacteriaceae (CRE)
-- unfortunately, one concern with antibiotic development is that smaller companies are less able to produce, market, and sell them.
-- AstraZeneca sold its antibiotics unit to Pfizer in 2016

Commentary:
--Novartis sales in 2017 were quite strong: overall sales were $49.1 billion, sales volume increased 7% (“more than offsetting the impact of patent expirations” per their own annual report), and their net income was $7.7 billion, an increase of 15% (see annual report: https://www.novartis.com/investors/novartis-annual-report/novartis-annual-report-2017#financial-performance .)
--Though this announcement is a huge blow to our present predicament of the increasing prevalence of "superbugs", which are likely to continue to proliferate, attack ever-larger segments of the world, and are largely untreatable, it is important to put this concern in the more holistic perspective that we need to limit the human role in accelerating the generation of these "superbugs":
    **decreasing the drastic overuse of antibiotics in farming
        --see http://gmodestmedblogs.blogspot.com/2018/04/antibiotic-overuse-in-animals-and.html ,which highlights this issue and also reviews articles on "super-resistant gonorrhea", and antibiotic overtreatment of sinusitis
    **decreasing the overprescription of antibiotics by clinicians:
        --see last blog on overtreatment of sinusitis
        --see http://gmodestmedblogs.blogspot.com/2016/01/antibiotic-overprescribing-and-acute.html  for the dramatic antibiotic overprescribing for acute respiratory infections
        --see http://gmodestmedblogs.blogspot.com/2018/07/antibiotic-overprescribing-in-urgent.html , which found that overprescribing antibiotics in primary care was much less than in urgent care and emergency departments
        --see http://gmodestmedblogs.blogspot.com/2017/06/decreasing-antibiotic-resistance-by.html for the positive effects of an inhospital antibiotic stewardship program
    **decreasing the use of broad-spectrum antibiotics​
        --see http://gmodestmedblogs.blogspot.com/2017/08/antibiotic-use-decreasing.html , showing a 5% decrease in unnecessary antibiotics
        --see http://gmodestmedblogs.blogspot.com/2018/07/penicillin-allergy-associated-with-mrsa.html for and article showing that the usually incorrect label of "penicillin allergy" leads to more use of broad-spectrum antibiotics, leading to suggestion that these patients be tested for true penicillin allergy
        --see http://gmodestmedblogs.blogspot.com/2015/02/pharyngitis-and-fusobacterium.html   which argues that penicillin is the drug-of-choice for pharyngitis, over azithromycin.​
    **and the attendent microbiome changes from antibiotics (especially broad-spectrum)
        --see http://gmodestmedblogs.blogspot.com/2017/04/antibiotics-microbiome-changes-and.html  for an article highlighting that antibiotic use leads to more high-risk colonic adenomas, with a dose-response curve
        --see http://gmodestmedblogs.blogspot.com/2015/11/longterm-microbiome-changes-with.html  , showing that there are long-term microbiome changes with antibiotics
        --see http://gmodestmedblogs.blogspot.com/2017/07/take-full-course-of-antibiotics.html  which argues that more infections are from normal commensals (in skin, gut, etc), and that taking a full 10-day course can lead to increased antibiotic resistance
        --see http://gmodestmedblogs.blogspot.com/2015/12/antibiotic-resistant-bugs-in-gut.html  showing that more kids have antibiotic-resistant bugs in their guts now, even without their having direct exposure
   **and, even focusing on aggressively decreasing global climate change, with its role in the increasing emergence of bacterial resistance: see http://gmodestmedblogs.blogspot.com/2018/07/antibiotic-resistance-increases-by.html 

So,
--it is not surprising that large companies like Novartis are scaling back on some of the most socially-important drug developments, given that their sole goal seems to be profits (which, by the way, were quite good last year). The issue, of course, is that such drug development requires large institutions that are capable of devoting large amounts of resources to development, testing, and producing
--the process of developing new drugs takes a long time. On the other hand, microbes seem to be quite facile in developing and spreading resistance. 
--and one huge concern is that there is a tipping point when further resistance increases exponentially: the point when the prevalence of antibiotic resistance in a community exceeds a certain threshold (numbers cited in the past have been around 7-15% for gonorrhea, but depend on certain aspects of the particular bug and the human response to it).
--the overwhelming social issue is that even now we are in pretty desperate need for antibiotics for several emerging infections, where the availability of effective antibiotics is lacking: for example with the current C. difficile infections, gonorrhea, etc. (see the WHO report http://gmodestmedblogs.blogspot.com/2014/05/who-report-on-antimicrobial-resistance.html​ )
--and, there is the additional issue which needs to be addressed: we not only need these newer antibiotics, but they also need to be affordable and accessible to those living outside the bubble of the high-income countries...

geoff​

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