Last June, Pfizer, the lone U.S. manufacturer of the injections, notified the Food and Drug Administration of an “impending stock out” that it anticipated would last a year. The company blamed “an increase in syphilis infection rates as well as competitive shortages.”
Across the country, physicians, clinic staff and public health experts say that the shortage is preventing them from reining in a surge of syphilis and that the federal government is downplaying the crisis. State and local public health authorities, which by law are responsible for controlling the spread of infectious diseases, report delays getting medicine to pregnant people with syphilis. This emergency was predictable: There have been shortages of this drug in eight of the last 20 years.
Yet federal health authorities have not prevented the drug shortages in the past and aren’t doing much to prevent them in the future.
Syphilis, which is typically spread during sex, can be devastating if it goes untreated in pregnancy: About 40% of babies born to women with untreated syphilis can be stillborn or die as newborns, according to the CDC. Infants that survive can suffer from deformed bones, excruciating pain or brain damage, and some struggle to hear, see or breathe. Since this is entirely preventable, a baby born with syphilis is a shameful sign of a failing public health system.
Normally, I’m all for getting out the torches and pitchforks for pharma companies, but there are some other considerations when it comes to penicillins. Due to the prevalence and severity of penicillin allergies, penicillin drugs basically have to be made in facilities dedicated to just that to avoid cross-contamination. If they used any of the same equipment (even packaging equipment) there would be too high a risk of causing allergic reactions via contamination of other medications, and there would be no way to tell which ones are contaminated.
The fix to this problem is to spread out the licensing and allow more companies to produce penicillins in appropriate facilities as opposed to leaving it in the hands of a single conglomerate.
Certainly, however the long tale of making penicillin is the fermentation process. That requires bigger or more vats on site in the existing facilities in the existing contamination free zones. Maybe there isn’t room in those… but then perhaps there is in the several company sites Pfizer purchased to create a monopoly on Bicillin.
I’m definitely being too flippant about “purchasing a brewery”, however not by much. They certainly have higher requirements for safety and sterility but beyond that, it really is just the same dumb process of “Put in the right food and bacteria, keep the temps consistent, mix, wait for 50 days, separate the Bicillin from everything else”.
Things only get complicated if the pfizer execs decide they need to “optimize” the use of facilities to maximize profits. Reusing fermentation barrels for other more profitable drugs. Or reclaiming space for other processes/office space. But like I said, because the process is that dead simple and the amount of Bicilin needed for the population is so little (We need less than 2.5ml per dosage).
We are talking about 200,000 cases, to treat all them we need a vat that can hold ~500L of materials to generate enough Bicillin for everyone in 50 days.
To get a picture of how much equipment that is, https://www.micetcraft.com/500l-micro-beer-brewing-equipment/
Yet Pfizer wants to tell use it costs them 38 million dollars to build out enough capacity? That’s some high bullshit to allow them to ramp up the price.
Part of what I was saying is that the fermentation barrels cannot be reused for other drugs. Also, with any biologically produced product in pharmaceuticals, they need to do extensive testing on each batch to ensure that there have not been any mutations or other contamination or production errors. The manufacturing of medicine is a highly regulated and monitored process that requires the manufacturer to meet a rather long list of criteria before the drug can be sold. Also, with bacterial populations, the larger the vat, the higher likelihood that a problematic mutation will occur and spread to a degree that would cause problems.
Certainly certainly. But breadth and scope of the amount equipment needed is important here. I grant everything that you are saying. I’m just saying that the physical dimensions of these fermentation barrels (see the image) is not high. Even if you shrink this down to 1000 500mL cans (soda can sized), the actual physical space that’d be occupied simply isn’t all that much.
It’s the equipment used to sterilize the primary equipment that can take up an absurd amount of space. Autoclaves are not small.