We read almost every single week that a new drug has been developed to treat a chronic condition. And, the price tag for this pharmaceutical miracle is $ 400K, $ 1KK, or even $ 2KK. That’s the pot at the end of the rainbow that all of our pharmaceutical houses are seeking.
Sure, some new firms have popped up that are willing to risk their capital to develop new antibiotics. Investors warmed to antibiotics-producing companies in recent years, partly thanks to a big push by the U.S. government (meaning $). The goal of the government was to reinvigorate research, since most of the large pharmaceutical companies abandoned the market. Since 2010, the US government has provided more than $1 billion to support drug development. A 2012 law made it easier for those successful firms to garner regulatory approval and also granted patent extensions for antibiotics that addressed the biggest public-health threats.
But, many of the new entrants have already thrown in the towel (Achaogen, Aradigm- and Tetraphase and Melinta are about to) – even Novartis and Allergan are leaving the antibiotic sector. Case in point- Zemdri (from Achaogen) is a great drug, viable against CRE (carbapenem-resistant Enterobacteriaceae)- but it took 15 years and all the money that the firm had to get approval. And, it failed to even generate $ 1 million in gross revenue in six months- which is why Achaogen filed for bankruptcy.
Here’s the problem. Chronic diseases generally require long term drug use. Antibiotic regimens don’t extend beyond a fortnight, at best. So, the financial benefits are pretty low- especially if it takes more than a decade to earn FDA approval. Only 5 of the 16 new antibiotics produced this century attained annual sales of $ 100 million or higher. The most expensive of them don’t even cost $ 1000 a day- which means $ 10K per illness. (New cancer drugs involve annual costs of $ 100K or more per patient!) That’s true even with the 3 million US citizens getting prescriptions every year and the 49K dying because of antibiotic resistance.
And, it doesn’t help that we are only talking about 18 specific microbes that we are so desperately hoping to treat with new antibiotics. Or that 5 of them (Chlostridium difficile, drug-resistant gonorrhea, carbapenem-resistant Enterobactericae (CRE), Candida auris, and carabepenem-resistant Acinetobacter) pose the most urgent needs. And, then, there’s the problem I reported on last August– that antibiotic resistance is being transferred to other microbes by plasmid transfer, making it easier and faster for microbes to develop resistance.
There’s another side to the coin. Given our knowledge about antibiotic resistance, many docs are reluctant to prescribe the new drugs. Hoping to save them for those recalcitrant microbes that our arsenal fails to treat. (Note: we’ve only developed two new classes of antibiotic drugs over the past two decades; the rest are wrinkles on the old formulations.)
It’s as if we told folks dying of cancer that we won’t prescribe that new formulation that seems great- instead, we’ll start you off on the drug we developed back in the 1960s.
No, we put patients on the newest stuff- even if the new cancer drugs only extend life by three to six months. Not so with the antibiotics.
Maybe we can provide incentives to promote those two methods we’ve learned can “repeal” antibiotic resistance (one of which I reported Monday).
Or seek out other ways the Feds will intervene. Either by increasing drug reimbursement, massive drug purchases (creating a stockpile), or other sorts of incentives to make the antibiotic sector more financially appealing.
There are some bills in the pipeline like the DISARM (Medicare reimbursement for new antibiotics) Act. And, we also have BARDA (Biomedical Advanced Research and Development Authority) but it’s been more interested in chem/nuclear and other public health threats- not drugs to counter antibiotic resistance- like the two new promising avenues we’ve covered in the past thirty days.
This is only going to get worse.
Our medical system is so broken, it is beyond belief. I am too speechless to comment further.
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‘Nuff said!
Wow! This is an eye-opener, Roy! Actually alarming. There is so much we don’t know until we need the drugs, but it costs us our bank account and home to receive them. Thanks for sharing this.
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There was an article yesterday (somewhere [I read too many different journals]) that health care in the US is about an $ 8000 tax on each of us. That’s not the health care costs- that’s how much more it costs in America than in the rest of the developed world. And, since Americans always complain about their taxes- why are they not complaining about this?
Why can’t they come up with needed drugs that don’t break the bank on those that need them?
It’s not like they get conjured up in the air. A fair amount of research is required. Nowadays, more than before. So, someone has to fund that research- not to mention the clinical trials.