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
Dr. Jonathan (Josh) Bloom, ACSH's Director of Chemical and Pharmaceutical Sciences, earned his Ph.D. at the University of Virginia and completed postdoctoral training at the University of Pennsylvania. During his 20-plus years in drug discovery at Wyeth, his research group discovered the antibiotic Tygacil®, approved in 2005. He holds 25 issued patents and has authored 35 academic papers. Since joining ACSH in 2010, he has written more than 2,000 articles and dozens of op-eds for major newspapers, including The Wall Street Journal and Chicago Tribune.
