No one in their small town had ever died from a fake drug before-at least, not that they knew of. It’s impossible to know for sure, in large part because it’s so difficult to know that it was a fake drug that killed someone.
Criminals often use falsified papers to sneak their fake drugs through checks, and the WHO estimates that about 30 percent of countries worldwide don’t have a functional drug regulation agency equivalent to the Food and Drug Administration in the U.S. Not surprisingly, these countries are more likely to be relatively poor, with underfunded and understaffed governments.
At the time, Laos was on the brink of a health crisis because fake drugs were making diseases, especially malaria, more resistant; drugs with too little of the active ingredient kill some of the bacteria but leave the hardiest in the body to multiply and then spread. Tabernero and her colleagues decided to try out the CD-3, in what would become the first field test of the device, in a developing country.
To see if a drug is legitimate, the instrument needs to compare it with a genuine example, which regulators may not have if the drug is rare or if the manufacturer changes the formula without warning.
The agency could provide a five-year grace period, he adds, to allow American drug companies to find trustworthy facilities and continue manufacturing to prevent drug shortages domestically.
It’s an elegant solution to a very complex problem: If citizens force the U.S. to play a larger role in the international conversation about falsified drugs, the drug supply would be safer within U.S. borders but would also extend far beyond.