Of the multiple barriers that get in the way of the development of new antibiotics, we certainly don't need another. But, this is real life, and money matters.
The business model for the discovery and development of antibiotics is very different from that for other drugs. This is because of the way antibiotics are used. Unlike chronic drugs, such as those to treat lipid disorders, high blood pressure, or depression, antibiotics are used for a specific time period, and (at least ideally) as seldom as possible. This makes is very difficult for pharmaceutical or biotech companies to spend the enormous amount of time and money that is necessary to develop these drugs, knowing that they may not only not make a profit, but more likely lose money, even if they succeed in coming up with something useful.
One of the Council's advisor, Dr. David Shlaes, an expert in microbiology and antibiotic development, has been discussing the business plan (or lack thereof) that, if not implemented correctly, will put up an extra roadblock where there are already plenty.
Dr. Shlaes, who has been giving lectures about the clinical development of antibiotics against specific pathogens (1), uses Pseudomonas aeruginosa as an example. Pseudomonas is especially problematic in hospitals, where is can cause infections of the urinary tract, lungs, and blood (sepsis). The bacterium is especially difficult to treat because of resistance to multiple classes of antibiotics.
But, he points out, "At least today, from a regulatory point of view, we still don’t know how to run a feasible trial that will result in marketing approval for such a drug. While I am confident that this problem will ultimately get solved, I am not so sure about the business model for such a drug."
Shlaes notes that, with regard to antibiotics, there is a conflict between a company business plan and the public health crisis of antibiotic resistance: "Since companies are not in the business of providing for the public health in some sort of charitable way, why would they spend their limited resources on developing this sort of product? We, as a society, need to provide a business model that will work."
You can read Dr. Shlaes full analysis of the issue here.
Josh Bloom
Director of Chemical and Pharmaceutical Science
Dr. Josh Bloom, the Director of Chemical and Pharmaceutical Science, comes from the world of drug discovery, where he did research for more than 20 years. He holds a Ph.D. in chemistry.
