Antibiotics now rank among the most counterfeited medicines in the world, feeding a global epidemic of drug-resistant superbugs.
A new surveillance and reporting program in 80 countries led by the World Health Organization shows that counterfeit antibiotics are a growing problem in all regions of the world, rivaling fake versions of erectile dysfunction pills like Viagra. Infections become superbugs by gaining resistance when the treatments used against them aren’t strong enough to kill them. It’s a growing problem as substandard counterfeit drugs become more prevalent.
The threat is already spurring a strong response from drugmakers such as Pfizer Inc., the U.S. maker of the Zithromax antibiotic, which has been focusing its anti-counterfeiting efforts on online pharmacies, collaborating with Microsoft Corp.
“Because the demand is so high for antibiotics, it’s not unusual to see those who falsify these products concentrate on them,” said Michael Deats, head of the WHO’s drug safety and vigilance team, in a telephone interview.
Earlier studies have found that Southeast Asia is a particularly large source of the questionable drugs, trafficking mostly in penicillin and their derivatives. The WHO says the problem is more widespread. England’s Chief Medical Officer Sally Davies has compared the gravity of the antibiotic resistance threat to climate change, requiring a similarly unified response from governments, industry and society.
With genuine medicines already losing potency against bacteria, the surge of counterfeits is particularly troublesome for public health leaders trying to curb the march to what the WHO has referred to as a post-antibiotic era in which everyday infections can kill.
“Substandard medicines can create resistance such that the bona fide medicine can’t treat the patient when he gets it eventually,” said John Clark, chief security officer for New York-based Pfizer’s fight against the counterfeit drug trade. “It’s a horrific situation.”
Part of the challenge is understanding the scale of the problem and where the fakes are coming from. Through the WHO’s surveillance program, links can be made across borders to identify high-risk sources, Deats said.
Pfizer’s effort with Redmond, Washington-based Microsoft seeks to identify affiliated networks of counterfeiters by tracking down computer servers and banks tied to their websites, Clark said. That has allowed them to take down thousands of affiliated pharmacies in one fell swoop and prevent them from resurfacing, he said.
In India, widespread resistance to common antibiotics is forcing doctors to prescribe previously spurned drugs like colistin, said Abdul Ghafur, an infectious diseases physician at Apollo Hospital in Chennai, in south India. Even healthy individuals who have never visited a hospital carry drug-resistant bacteria, he said.
The situation led to India heeding the Chennai Declaration to tackle antibiotic resistance and adopting in March the so-called “H1 rule,” where pharmacists must insist on prescriptions for 24 second- and third-line antibiotics.
Over the next two to three years, the list will be gradually expanded, and drug inspectors will help enforce the law, Ghafur said. “There are half a million pharmacies in India so implementation will take some time,” he said in a telephone interview.
India produces about 40 percent of the world’s supply of bacteria-killing drugs, according to Tim Walsh, a professor and infectious diseases researcher at Cardiff University in Wales.
The situation isn’t confined to the developing world. “Very high rates” of resistance have been observed in all regions and in bacteria that cause common infections such as those related to wounds, pneumonia and urinary-tract conditions, the WHO said in its first global survey of antimicrobial resistance in April.
Similarly, fake antibiotics are just as likely to reach patients in the U.S. and Europe as in poor countries through online pharmacies. Of more than 10,000 online outlets surveyed last year by the U.S. National Association of Boards of Pharmacy, 97 percent were out of compliance with U.S. pharmacy laws and standards.
The fake drug challenge comes amid concern about the quality of real medicines, especially generics. The U.S. Food and Drug Administration has restricted imports of drug components made by India’s Ranbaxy Laboratories Ltd. and Wockhardt Ltd. Now counterfeiters are adding to their woes.
“Generic-drug makers, just like research-based manufacturers, get just as concerned about their drugs becoming falsified,” Deats said. “They can be the target just as much as anybody else.”