Will regulatory failures in the developing world make current tuberculosis treatments ineffective?
In a New York Times op-ed, Roger Bate reveals the results of our study assessing the quality of anti-tuberculosis drugs from 17 low- and middle-income countries – and they’re not pretty. Our findings are particularly worrying because of the sheer prevalence of TB: The World Health Organization estimates there were 8.8 million TB cases in 2010, which caused 1.4 million deaths.
We find that nearly 10% of all samples failed basic quality tests (and many more would likely have failed more stringent testing). Unsurprisingly, the failure rate was highest in African cities (17%), but even middle-income nations like Russia, Turkey, Brazil, Thailand, and China had a worryingly high failure-rate (4%).
This is partly an import-export issue. Porous borders, overburdened customs officials, and ill-conceived drug-approval systems allow non-registered medicines to reach millions of patients. Unsurprisingly, non-registered drugs fail quality tests more often.
But it isn’t only a customs problem. More than half of our failed samples contained over 10% of the required active pharmaceutical ingredient, indicating that they were not simply counterfeits smuggled in by drug gangs. These substandard medicines had either been poorly manufactured, improperly stored, or nefariously designed to trick quality assessors.
No government has the capacity to conduct in-depth drug quality assessments at its borders. Instead, countries rely heavily on companies’ drug-production certifications, only occasionally assessing the quality of products on the market.
This can allow certified companies to get away with under-dosing products or allow the sale of degraded or expired products. Not only does this mean failures are harder to catch – they are also more dangerous. More than half of our failing samples had been produced by legitimate companies.
Medicines with insufficient drug dosage contribute to drug-resistance, which is already an immense problem in combating tuberculosis. Treating drug-resistant tuberculosis can cost up to $200,000 per patient, and may not work.
It’s time to recognize that the regulatory problems in the developing world could have serious implications for treating tuberculosis here at home.
* Luanda, Angola; Lubumbashi, Democratic Republic of Congo; Cairo, Egypt; Addis Ababa, Ethiopia; Accra, Ghana; Nairobi, Kenya; Lagos, Nigeria; Kigali, Rwanda; Dar es Salaam, Tanzania; Kampala, Uganda; Lusaka, Zambia.
† Chennai, Delhi, Kolkata.
‡ Bangkok, Thailand; Beijing, China; Istanbul, Turkey; Moscow, Russia; Sao Paulo, Brazil.
API = active pharmaceutical ingredient.