LOSING THE ANTIBIOTIC ARMS RACE:

Antibiotics face a worthy, endlessly adaptive enemy: bacteria. The more we use each drug, the less effective it becomes. That means that we need a constant flow of new antibiotics. And we’re not getting them, in part because the market for developing these vital drugs is broken.

Here’s the basic process for a pharmaceutical company to develop and profit from a drug. First, you spend a bunch of money looking for compounds that might do what you want to do. Then you file a patent application, and register with the FDA and regulators in other countries. This allows you to start spending a boatload of money on clinical testing that will find out whether your new drug actually does something you want it to do, without killing or maiming the patient. At some point during the clinical trial process, your patent will be awarded. Then you finish clinical trials, and if the drug looks good to everyone, you can start selling it. You have from now until the patent runs out to recover the vast sums you have spent on developing this drug (plus some extra for your shareholders, and to cover the costs of all the R&D that did not lead to blockbuster drugs). After that, generic competition will enter the market and compete your margins down to almost nothing. That generally gives you a little over 10 years to make all of the money on a new drug. For example, Opdivo, the exciting and fantastically expensive new cancer treatment that was approved late last year, will probably be eligible for generic production in 2027.

Do you see why this is such a problem for antibiotic development? If a company develops an exciting new cancer treatment that does a great job, oncologists will start pumping the stuff into patients as fast as they can get permission from insurers. If a company develops an exciting new antibiotic, infectious disease specialists will hold onto it as long as possible, using older generics whenever possible and bringing out your new drug only when everything else has failed. By the time they’re ready to use it more broadly, the drug will be off patent, and the company that developed it won’t make any money off of it.

As health policy, this is absolutely the right thing to do; it stretches out the time we get to use an effective antibiotic, and saves costs to boot. But as drug development policy, it’s disastrous. Companies are less and less interested in creating new antibiotics, because it’s too hard to make money there.

I’m very concerned about this; we need to change the incentives. Also, we need more research into phages and other non-antibiotic approaches.