CGD Drug Resistance and Global Health E-Newsletter Featured Column
The Pharmaceutical Industry and Antimicrobial Resistance
By Eddie Power, PhD MBA
Global Medical Director, Clinical Research
Cubist Pharmaceuticals
Antimicrobial resistance has existed as an integral component of ecosystems and will continue to exist naturally regardless of the medicinal use of antibiotics within the human population. Nevertheless, all stakeholders agree that the documented rise of antimicrobial resistance is a key threat to human health, and is particularly a danger in the developing world where effective alternative medicines are limited. Given this basic premise, what then is the pharmaceutical industry’s role in managing the development of resistance to antimicrobials?
The industry occupies a unique position with regard to resistance. As discoverers and manufacturers of antibiotics, pharmaceutical companies seek to develop new and effective products. However, for complicated but familiar reasons -- scientific, technological, regulatory and economic – the pipeline has become increasingly sparse. And proposals to address antimicrobial development in general are not geared to stimulate development that mitigates antimicrobial resistance.
Pharmaceutical companies, as marketers of antimicrobial products, are often pilloried for perceived profiteering. The contention is that aggressive selling techniques lead to overprescribing of antibiotics and, hence a greater propensity for antimicrobial resistance to develop. The reaction of regulatory and professional organizations in the developed world has been to address such overprescribing by restricting the use of newer (and more expensive) antibiotics while favoring older (and cheaper) generic versions. The logic in this scenario is interesting – wait for resistance to develop to existing antibiotics and then use newer ones when the older ones fail as a fall-back.
Is this the best approach? Or rather, should we preempt the development of resistance by using newer antibiotics first? After all, they tend to be more potent since they are designed to tackle resistant as well as “ordinary” microbes. If resistance develops to newer agents, then older existing ones should still be effective since they have not been exhausted. Or, is the “reservist” approach – really driven by cost considerations – justified by science? Generally, when considering volume instead of cost, prescriptions for generic antibiotics far outweigh those for newer patent-protected products. Which has a greater impact on resistance development?
The issues in the developing world are affordability and restricted access to patent-protected medicines. The profiteering version of reality could conclude that unaffordable prices and limited access will contain resistance at the population level. At the individual level, however, this raises serious moral and ethical issues. And, how does the generic industry affect the resistance equation? Multiple low-cost generic versions of the same antibiotic may address affordability and access issues for the individual, but what are the resistance consequences at a population level?
The issues are many and complex. It is clear that the pharmaceutical industry (proprietary and generic), with such a central role, should be an equal partner alongside governments, public and professional institutions, and philanthropic organizations in establishing an approach of shared accountability in seeking effective and sustainable solutions to the issue of antimicrobial resistance.