You could probably classify this month’s editorial as a sequel to last month’s, where I talked a lot about cancer but mentioned other areas that might be getting short-shrift because of pharma and biotech’s focus on oncology applications these days—antibiotics being one of the areas I cited as getting a relative dearth of attention.
I didn’t really plan to pick up where I left off, but on reviewing my feed on Facebook one day in late February, one of my local acquaintances posted about his dismay over the fact that there are, apparently, no manufacturing plants for aspirin or antibiotics in the entire United States anymore. I scanned through a transcript of a recent episode of NPR’s “The Diane Rehm Show,” which I hadn’t completely listened to but I figured was the source of this information and, sure enough, it seems to be true.
What got me about the Facebook post, though, was a statement to the effect of, “if you’re taking an antibiotic and it doesn’t seem to be working, it probably isn’t.”
The implication was a cause-and-effect between such drugs coming exclusively from overseas and mostly from non-Western nations and the assumption that they are now flawed or useless medicines as a result of that.
Now, I’m not saying we shouldn’t be worrying about quality controls. It was just last issue, in fact, that I ran a news brief in our “Business & Government Policy” section about how the U.S. Food and Drug Administration was finally able to get China to agree to an allowance for 10 additional FDA drug inspectors in the country. And one of Diane Rehm’s guests mentioned a recent case in Kashmir where a massive amount of antibiotics distributed in public hospitals contained absolutely no active ingredient whatsoever.
But I think it’s easy to get fixated on such juicy details and miss the bigger picture.
Who’s working to create the next generation of antibiotics?
With regard to last month’s editorial, I had a brief but nice set of email interactions with a reader, Dr. Mansour Bassiri—the chairman and CEO of Bioxiness Pharmaceuticals Inc.—whose own company is committed to developing a new class of antibiotics. Bassiri shared with me a graphic from a recent journal article that noted that in 2013, antibiotic-resistant MRSA killed more people in the United States than AIDS, hepatitis B and tuberculosis combined.
Dr. Bassiri also shared with me a quote from 2011 from FDA Commissioner Dr. Margaret Hamburg that went, “Today, antibiotic-resistance mechanisms have been reported for virtually all known antibacterial drugs available for clinical use—and, as Dr. Hughes said, it is more than just hypothetical to talk about a return to a 'pre-antibiotic era' in which we no longer have effective tools to treat serious infectious disease … This threat affects everything from ear infections in school children to global infectious diseases … and the consequences can be tragic.”
And I have to agree with the “tragic” part. As concerned as we should be about quality, it would be even more tragic to have nothing to turn to at all than to simply have risks in the supply chain. And while I am heartened by the efforts of companies like Bioxiness, I am reminded that at one time, in the not-so-distant past, 11 Big Pharma companies were involved in antibiotic R&D. An article I read from 2013 said we were down to four: GlaxoSmithKline, Pfizer, AstraZeneca and Merck. But a Reuters article in 2013 as well noted that actually, Pfizer is focusing its anti-bacterial work on vaccines now and AstraZeneca is scaling back its anti-infective spending.
Here’s hoping the few big players still in the game and the smaller ones have what it takes to keep us from being without any antibiotics to choose from soon.