Are we reverting to a pre-antibiotic age? Dirty hospitals, poor prescribing practices by physicians and poor patient adherence to correct antibiotic use mean that routine medications are becoming increasing obsolescent.
The risk is accelerating because of new global substandard medicines — caused by inferior ingredients or inadequate production techniques — that are driving a new wave of antimicrobial resistance (AMR). With few financial incentives for major pharmaceutical companies to find new antimicrobial agents, the future may be bleak. Old medicines will become obsolete, and few new medicines will be there to replace them.
The U.K. government considers that AMR could cost society a fortune within decades — perhaps a six percent reduction in global wealth, or up to $14.2 trillion ($14,200 billion) by 2050. In my just-released study on how substandard medicines contribute to antimicrobial resistance, I found that the threat of AMR is increasing due to poor quality medications, and that India is ground zero when it comes to most of these problems.
Research by physicians and scientists at the University of Queensland in Australia suggests that treatment with substandard medicines containing sub-therapeutic concentrations of active ingredients causes resistant strains to breed uncontrolled.
Yet, in the cutthroat world of cheap generic drug production, the lowest cost usually wins the contract to supply — whether to a pharmacy chain, hospital, or even a large government program. As a result, legitimate manufacturers are constantly looking for ways to lower costs and beat the competition. In the West, decent regulators and quick feedback from physicians means that poor quality producers are not likely to survive in the market. But in emerging nations, sloppy production is unlikely to be detected. And in some, notably India, where the government prioritizes protecting the industry over public health, corner-cutting production is actually defended by the government.
While these products are sold as generics, they should not be regarded as such. They are not the bioequivalent of innovator or generic products; many don’t even pass basic physical and chemical stability analysis. They are simply poorly made by legal manufacturers, and they undermine the reputation of real generics.
My team’s research found that roughly six percent of several thousand samples of antimicrobial medicines bought from 19 emerging nations were substandard. India is often viewed as the pharmacy to the developing world, and many of these products are made by legal and government-protected Indian manufacturers. While the vast numbers of cheap medicines produced in India have undoubtedly saved countless lives, their cheap production is a double-edged sword.
Given that antibiotics are so cheap in India, antibiotic use has become, in effect, a substitute for proper sanitation. My researchers found important medicines (like the carbapenem antibiotics that are used to treat infections caused by multi-drug resistant bacteria) available over the counter — in a handful of cases, even without a prescription. In the West, these medicines are strictly used as a last resort for controlling AMR, administered only in hospitals and by trained medical staff.
Another example of the Russian roulette being played in India is the startling number of multi-drug resistant bacteria that were discovered in the public water supply in New Delhi.
While India is not alone in proliferating sub-standard manufacturing, the confluence of inexpensive medicines, sometimes of dubious quality, widespread use of antibiotics, instead of the more traditional and effective methods of hygiene, in addition to the physician incentives to over-prescribe and the vast dense urban settings, have created a perfect storm for the emergence of drug-resistant bacteria. The global spread of the highly resistant New Delhi beta-lactamase-1 (NDM-1) plasmid may have been exacerbated by substandard antibiotics. NDM-1 was first identified in 2008 in a Swedish patient returning from India with Klebsiella pneumonia. It has now been found in 70 countries. National borders are no defense unless strict quarantine measures are in place, such as occurred with the recent West African Ebola epidemic. No one has called for that yet, but it might need to happen at some point.
Rich nations generally have fewer poor quality medicines caused by too few or incorrect ingredients. The problem is more that the formulation of some imported medicines is not as precise and, hence, they don’t function as well, or sometimes at all, by comparison to generic drugs made at home.
This lack of equivalence has been found across a wide range of antibiotic agents including vancomycin, amoxicillin, meropenem, gentamicin, and ciprofloxacin. For vancomycin, the therapeutic failure of allegedly generic vancomycin led to MRSA peritonitis and bacteremia. European and U.S. authorities have boycotted hundreds of Indian-made products that have not shown full equivalence. The German government, for example, suspended 80 Indian products made by 16 companies because they failed established standards and lacked bioequivalence.
It is time for the international medical community and global regulatory bodies to agree on a more effective way to identify substandard antibiotics and remove them from the supply chain. Otherwise, we can look forward to a return to the “pre-antibiotic era” of fatal infections, where quarantines become a way of life, and currently routine surgeries and diseases transform into life threatening situations.
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