We need new drugs to fight the surge of antibiotic-resistant bugs that have been making the rounds in recent years. And we have them! But there's a catch:
Six startups have won Food and Drug Administration approval for new antibiotics since 2017. All have filed for bankruptcy, been acquired or are shutting down.
The problem turns out to be a simple one: there aren't really that many superbugs out there. This means that demand for super-antibiotics is fairly low, which makes them very expensive, which in turn reduces demand even further. A million bucks for a cancer drug is pretty ho-hum these days, but apparently we haven't quite gotten ourselves used to million-dollar penicillin:
About 13,000 people in the U.S. each year develop a severe type of drug-resistant infection that Achaogen’s drug Zemdri was developed to defeat. Up to half of people hospitalized with such infections die. They are among the more than 35,000 people in the U.S. who die annually from drug-resistant bacterial or fungal infections, a toll that has risen in recent years.
The year Zemdri was approved, Achaogen spent almost $200 million on manufacturing, marketing and other costs and generated $800,000 in sales of the drug. Achaogen’s stock price fell more than 96% from approval in June 2018 to the end of the first quarter in 2019.
I don't know how much $800,000 represents in doses, but it's way less than 13,000 people. For some reason, thousands of people die every year from this particular type of infection, but almost none of them were prescribed Zemdri to treat it. This is not a good thing for the future development of super-antibiotics
During my underwriting years, an article about the lack of new products in the pipeline to replace those lacking efficacy against new bacterial infections made a strong impression, which I was reminded of when a friend died of MRSA. More recently, a more resistant MRSA strain was identified.
Given how our government can gear up in a pandemic to promote development of a vaccine - one on which scientists were already working - it seems that it's past time for consideration of a collaborative effort to solve this longstanding problem.
Not having medicine for orphan diseases due to the high cost of development & relatively low number of affected people is bad enough, but the possibility of unchecked lethal bacterial infections is unacceptable & should be avoidable - like the coronavirus (& typhoid, which the US dealt with more firmly), it is a public health issue.
+ many. What's likely to happen is that some azzole like Shkreli will buy the patent and sell it for $10,000 per dose to desperate families.
Which is why there is no reason at all that the government shouldn't take these drugs all the way through human trials and then contract to have the number of doses needed made on a cost plus basis. This is a market failure where the cost of development (not production) exceeds most consumers ability to pay.
Yes but remember "public health" is creeping woke fascist communism! /s obviously.
Can’t they just take ivermectin?/s
The United States is not the only country in the world with the resources to develop new antibiotics.
They need to be treated like a strategic reserve, with a guaranteed federal purchase order and stockpiles so they can be very carefully rationed (especially if they're "last line" antibiotics).
The Free Market gives us Viagra, but alas there is not always profit in simply saving a life.
"...thousands of people die every year from this particular type of infection, .."
Source?
"...but almost none of them were prescribed Zemdri to treat it. .."
According to wikipedia:
"... As of 2019 it is recommended only for those in whom alternatives are not an option.[1] ..."
According to Wikipedia "A generic version [of plazomycin] is manufactured by Cipla USA.
Seems like people who died needed a different option.
"Seems like people who died needed a different option."
They needed a better option, but the FDA recommendation seems to be saying that this drug usually isn't it. Otherwise why put it last in line?
It gets put last in line in the hope that means it will not be overused to the point that the bacteria develop immunity to it too.
I suggest reading the EU's write-up for why Zemdri was withdrawn for approval by its maker: https://www.ema.europa.eu/en/medicines/human/withdrawn-applications/zemdri
"Commercial reasons."
So, they can't make an obscene profit.
It's too bad the US has no public entity large enough, and already spending tons of money on healthcare, to subsidize the manufacture of and/or construct its own pharmaceutical factory to make drugs that are both sorely needed by American citizens and also somehow unprofitable for private firms to make on their own. Perhaps someday the economists and political scientists will learn how to deal with market failures like these.
They may need to change patent law/approvasls to require companies produce new drugs or lose the patent. Either that, or allow the government produce the drug with a small licence fee. Longer term I think governments should pay for the approval testing for drugs that have limited commercial value and then contract their production somewhat how military equipemnt is produced (with, hopefully less waste!).
Part of the issue with antibiotics is specific to antibiotics: it's really important to use the newly-developed last-line antibiotics as rarely as possible, to make development of immune strains that they don't work on as slow as possible.
So unlike most drugs, "make it easily available" is the wrong strategy.
"All have filed for bankruptcy, been acquired or are shutting down."
One of these things is not like the others.
"Was acquired by a bigger drugmaker" is a very common success story in drug development.
I think the government should treat any sort of non-preventible disease, especially communicable ones.
But can't we at least agree that the government should pay for these meds when someone has a resistant type so we can make sure those bugs are killed killed killed and don't infect others?