IDSA has spoken out in various publications (“Bad bugs, no drugs”, ’10 x ‘20 initiative) about the various disincentives for industry to engage, so I only mention a few key points: the loss of efficacy over time due to resistance development; the short treatment courses of curative vs the life-long dependence on palliative medicines; high regulatory hurdles for the development of drugs against MDR pathogens; the lack of international harmonization of endpoints for regulatory approval.
Industry is good at developing and marketing but will not invest in a product that is going to be restricted, get labeled as a 3rd tier ‘reserve’ agent, or which is undifferentiated and replaceable with a generic. For them, the ideal “Target Project Profile” looks more like this: Broad therapeutic and prophylactic use, plus empiric use, with broad-spectrum activity across multiple indication, and IV and PO formulations for step-down use. The last group of drugs that came close to this profile were the fluoroquinolones.
“Reward companies for innovation in antibiotics. Both Push and Pull incentives are needed” LSE [2]
CEOs are under the gun to deliver profits to shareholders, they don’t get a bonus check for being ‘do-gooders’. Until recently, the only way for antibiotics to generate profits commensurate with cancer, diabetes and asthma drugs, was to market them for mass consumption. Nowadays, only the orphan drug pathway is somewhat attractive for Big Pharma to engage.
I got thinking about this topic as I read the ‘Perspective’ by Laxminarayan in Science [1]. The author makes the point that “contrary to popular belief, many new antibiotics have been introduced during the past two decades”. His opinion seems based on the list of antibiotics provided in Fig. 3 of the article which unexplicably mentions drugs that never made it in the US . Such factual errors create the false impression of a vibrant industry effort where there is actually very little. He then makes the case for investments in education, in diagnostics, in vaccination, and for prudent use, all truisms we are familiar with and which everyone can support.
Regrettably, this ‘Perspective’ does not provide new ideas how market forces and regulations can be shaped to create a healthy balance that would encourage innovation, keep resistance at bay, and avoid making the next decade the first of the post-antibiotic era. (I still recommend reading the article as it has some nice color graphs and tables).
As a non-MBA, non-Econ major, I see an antibiotic market that is regulated to the hilt in certain areas (human use) but not in others (veterinary use). Investors have to live with the occasional ice-bucket challenge from FDA which
However, not all is bleak: In their heart of hearts, industry likes antibiotics because efficacy read-outs can be obtained so much earlier than for any other medicine class. Antibiotics have always been good for risk-mitigation in a diverse portfolio, and they make very good PR. Think Novartis (Coartem -malaria), Merck (Ivermectin – onchocerciasis), Bayer (Moxifloxacin – MTB) and others…
References:
[1] R Laxminarayan. Antibiotic effectiveness: Balancing conservation against innovation. Science 2014, 345: 1299
[2] Sept 2009 Conference on Innovative Incentives; 2009 LSE report, Mossialos: http://www.euro.who.int/__data/assets/pdf_file/0011/120143/E94241.pdf
