Is the pharmaceutical industry doing enough to combat antimicrobial resistance?

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Enough for whom is one critical question. And “how” is another.

If we mean that pharma companies should combat resistance by promoting antibiotic stewardship and thus discourage the use of their products… well, that’s not realistic, is it? And if we mean that they should combat resistance by developing new antibiotics, then the answer is not much more encouraging.

Big Pharma has basically given up on antibiotics. It’s not that the risks are too high, it is that the rewards are too low. New antibiotics are being introduced. But their sales are a tiny fraction of sales in other drug classes.

From Antibiotics in late clinical development

So from the standpoint of established pharmaceutical companies, they are indeed doing enough to combat resistance: they wait as biotechs take all of the risk of developing new antibiotics, and then acquire them.

The for-profit approach to funding biomedical R&D has several flaws (along with many virtues), and these flaws are manifest when it comes to antibiotics:

• Although resistance is a big problem, most infections are treatable by well-established, low-cost antibiotics. This is true even of infections caused by resistant bugs – most are resistant to only one or two clinically relevant antibiotics, very few are resistant to three or more, and almost none are resistant to all. If a patient fails Cipro, then maybe Bactrim will do the trick. Both are cheap and effective. The result is limited demand and weak pricing power for new antibiotics.
• New antibiotics that treat troublesome resistant infections are often “saved” by doctors, who rightly fear that excessive use will lead to the development of resistance. This further depresses sales.
• Antibiotic resistance is a communal problem, but doctors are obligated to put their patients’ interests first. They may prescribe antibiotics as a precaution or in the face of diagnostic uncertainty. The individual patient benefits, but the community bears the cost of increased resistance.
• The best method of combatting antibiotic resistance is to prevent, rather than cure, bacterial infections. This means investing in public health measures – clean food and water, education, vaccines, infection control measures in hospitals, nursing homes and clinics. Some profit (but not much) can be made in the vaccine business, but there is no profit at all in other public health measures, and pharma companies do not engage in them.

There have been some attempts to make antibiotic R&D more profitable – extended patent lifetimes, less-onerous clinical testing guidance, proposals to guarantee minimal sales. But these are half-measures that merely nibble around the edges of the problem, rather than go to the heart of it.

And the heart of the problem is that for communicable diseases in general, and infectious diseases in particular, there will always by a “tragedy of the commons” dynamic in which what is good for individual actors is not good for the community at large.

This is why we need to flat-out socialize the development of new antibiotics, and increasingly regulate the use of existing ones. A division of NIH should vertically integrate discovery, pre-clinical development, clinical testing and distribution of new antibiotics. It should also develop and enforce guidelines for the prudent use of new and old antibiotics, starting with the elimination of sub-therapeutic levels of antibiotics in livestock feed, and clamp down on the useless practice of prescribing antibiotics for colds.

We will never go back to the wonder drug days of the 1940s and 1950s when new antibiotics were being discovered faster than new resistances could develop. But we could stop the tide of resistance, and maybe even turn it back a little. No one will profit, but everyone will benefit.