Germ warfare

Do we need a National Institute of Anti-Infective Drugs?

MRSA meets antibiotic

Occasionally I write about the ever-encroaching threat of infections that don’t respond to our embattled arsenal of antibiotics and antivirals. The threat came closer two years ago when my son was hospitalized for days with an infection that wasn’t responding to IV antibiotics. I found myself in his hospital room talking with a surgeon about what would happen if they had to cut out the infection. (Fortunately, not.)

And the threat took another step earlier this month when Novartis joined the ranks of drug companies walking away from anti-infection research, explaining that its science was good but the business was not.

With corporations backing off, do we need a National Institute of Anti-Infective Drugs?

Jennifer Leeds, head of the Novartis anti-bacterial infection group that is being shut down, graciously responded to my question on LinkedIn with an enlightening answer:

“Maybe. The challenge isn’t only in the discovery and development space. The real challenge is in the commercial model. These are low volume, high dose, sterile drugs (therefore often high cost of goods) that sometimes have to be made in dedicated manufacturing facilities (all B-lactams do, and you can’t even mix different B-lactams classes in a single facility), for which the tolerance for pricing is extremely low given the historical low cost for antibiotics, and in many circumstances they are not reimbursed. So, show me another market where low volume, high cost, and low margin is sustainable. Oh, there isn’t one. So, yes, something needs to change.

“The problem I see with trying to ‘institutionalize’ this is that there’s a poor economy of scale in this business because of the different manufacturing needs. Unlike biologics, there really isn’t a ‘platform’ model for manufacturing. So, a National Institute would have to still invest in diverse manufacturing needs. But, it’s time for a change nonetheless. To what? I don’t know.”

Just maybe, it’s worth considering bringing the federal government into the business of making crucial but unprofitable drugs, not just antibiotics but certain pain medications and anesthetics and other “medically necessary” drugs now in short supply. That’s not impossible even in these times, when even this Congress wants to give the NIH more money.

(Above: MRSA meets antibiotic, courtesy RSCB Protein Data Base)

 

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