The Justice Department and the Food and Drug Administration are looking into whether Ranbaxy Laboratories, one of the world's biggest makers of generic drugs, manufactured substandard HIV drugs that were administered to thousands of poor Africans. But this type of tragedy has already affected American consumers.
Between November and February, 95 Americans died after experiencing an allergic reaction to heparin, the FDA reported. The blood-thinning medication contained an active pharmaceutical ingredient from China that the FDA suggests was likely "intentionally contaminated."
And for each American death from tainted drugs, there are thousands of similar tragic stories around the globe.
• The World Health Organization estimates that up to one-third of all medicines in poor countries contain too little or no active ingredients to work properly.
• In the 1995 Niger meningitis epidemic, 50,000 people were inoculated with fake vaccines - and 2,500 died.
• In 2006, more than 100 Panamanian children died after ingesting cough syrup that had been mixed with diethylene glycol, a common component of antifreeze.
• About 200,000 people die every year from malaria, the WHO estimates, because of poorly produced and inadequately delivered drugs.
Because it is difficult to identify deaths from counterfeit drugs - did the patient die because he succumbed to the disease or because the drug failed to work? - many more wrongful deaths go undetected.
Criminals counterfeit drugs because of the tremendous gains available at comparatively low risk. Fake ingredients are often significantly cheaper than authentic chemicals.
In some ways, it's surprising that counterfeiters took so long to target the U.S., the world's most lucrative pharmaceutical market.
For decades the U.S. system has worked well. Stringent regulation coupled with commercial vigilance kept counterfeits to less than 1 percent of the total market.
And a knee-jerk response to the heparin deaths would be a mistake. Better cooper- ation is clearly needed between the U.S. and Chinese governments. But banning imports would increase the price of many drugs, possibly harming thousands who would be unable to afford their prescriptions.
U.S. drug companies purchase 40 percent of their advanced pharmaceutical ingredients from India and China. That rate is expected to double within the next 15 years. While these countries can produce good advanced ingredients and finished products, lax regulation and poor rule of law means that myriad counterfeits remain. Until these problems are controlled, it is better for companies to import the active ingredients than for patients to buy finished products, because companies have greater knowledge to weed out bad products.
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