I remember having my mind blown in an undergraduate microbiology class back in university. In ten minutes, the prof taught us how to make antibiotic-resistant bacteria. Here is the simple process. Coat a plate of bacteria with a very dilute antibiotic. Most bacteria will die, but if you make the antibiotic dilute enough, some will survive. Take those survivors, transfer them to a new plate, and repeat the process, this time with a slightly more concentrated antibiotic. Take the surviving bacteria and continue until you have a strain that can survive a full dose of the antibiotic.
This process is what occurs in human populations when we use antibiotics irresponsibly. Patients who fail to take the full dose of antibiotics for the entire time specified by their physician are the equivalent of applying a diluted amount of drug to the bacteria. The surviving bacteria, which have some capacity to resist the antibiotic, then recolonize the person, requiring even stronger antibiotics to manage. This continues in the population until that fateful day when we have no antibiotic capable of handling that bacteria. This is how antibiotic resistance is created.
Medical researchers are talented, though, and should be able to produce newer antibiotics to manage these “superbugs.” A confluence of factors, sadly, combine to limit our ability to respond. As a result, we are developing fewer new antibiotics at a time when antibiotic resistance is rising.
These factors have less to do with our ability to discover antibiotics and more with the system we have to approve and distribute them. It is interesting to look at this through a perspective of organizational wisdom. Let’s explore these barriers and then see what some people are doing to overcome them.
Barriers to antibiotic development
Barrier 1: Cost
I worked for ten years in the biotech industry, developing new drugs. The one thing I learned about making drugs was this—we are bad at it. The complexity of the human body is greater than our intelligence’s ability to understand it. Thus, the only way we truly know if a new drug is safe and effective is to give it to someone and see what happens. This is, in essence, what clinical trials are.
To balance people’s safety with our need to develop new medicines, we have created an elaborate regulatory framework of how to conduct a clinical trial. The clinical trial process creates a formidable barrier to drug development. On average, it takes companies twelve years and $350 million to approve a new drug.
For every hundred drugs entering the clinical trial process, eighty will fail somewhere along the process. Each of those eighty failures consumes part of that $350 million investment. Those twenty drugs that get approved bear the burden, then, of not only recouping the $350 million investment for their own development but the partial investment for the eighty failed drugs. And they only have eight years to do it—patents are twenty years, less the twelve years spent in clinical trials leaves eight years of market life before generic manufacturers copy the drug and drive prices down.
If this financing equation does not balance, then this development process stops. This is what is happening in the antibiotic market, as we will see with the next barrier.
Barrier 2: Demand
Given the rise of antibiotic-resistant infections, one would think there is a healthy market demand for new antibiotics. This, however, is not the case. As explained above, the nature of how bacteria become resistant to antibiotics means the more frequently an antibiotic is used, the more likely a bacterium is to become immune to it. Thus, physicians horde new antibiotics. They refrain from prescribing them in anything but the direst of cases.
Doing this retains the efficacy of the new antibiotic for as long as possible. It also, however, starves drug developers of the revenues they need to invest in the development of future antibiotics. And so, as our need for newer antibiotics rises, the system we have created to develop them is grinding to a stop.
Solution: The Netflix Model
All you old people will remember the days when, if you wanted to watch a movie at home, you had to go to the store and rent one. You selected the video and you paid your money, which made its way back to the developers of that specific movie. You young people are thinking, “Barbaric!” but those were the dark times we lived in back then.
Today we pay a subscription to a streaming service like Netflix, where for a monthly fee, we can watch as many or as few movies as we like. Netflix makes money even if we watch zero movies, while we get the ability to watch whatever we want, whenever we want.
Some businesses are experimenting with a similar subscription model for antibiotics. Healthcare providers pay a flat rate for access to antibiotics, whether they use a little or a lot. Drug developers continue earning revenues to fund the next development cycle, even when doctors horde the newest antibiotics.
Perhaps this clever innovation could be what opens the door to a new era of medical advancement. Thanks, Netflix!
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