The hidden danger of fake and substandard medicines

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    Phake: The Deadly World of Falsified and Substandard Medicines
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Article Highlights

  • Poorly made medicines kill more than 100,000 patients every year--disproportionately affecting the poor

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  • Bad drugs aren't confined to developing world; #FDA announces 19 medical practices bought counterfeit cancer drug

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  • Sooner or later, someone you know well will be harmed by a substandard or fake drug

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STELLENBOSCH, SOUTH AFRICA - Counterfeit or poorly made medicines probably kill more than 100,000 patients every year - disproportionately affecting the poor, particularly in Africa. But bad drugs are not confined to the developing world: in 2008, 149 Americans died from contaminated counterfeit heparin, a blood thinning medicine. And the U.S. Food and Drug Administration (FDA) announced on February 14th that 19 medical practices had bought counterfeit Avastin, an important cancer drug. So far no adverse reactions have been reported.

Most fake pharmaceuticals are manufactured in emerging markets, and efforts to attack these lethal producers must begin in countries like India and China where legitimate manufacturers and domestic consumers also have a stake in shutting down the fake trade. Waiting for domestic action on the part of a few countries may be too dangerous and could result in many unnecessary deaths. Introducing an international treaty to combat fake medicines is necessary and already overdue.

My upcoming book "Phake: The Deadly World of Falsified and Substandard Pharmaceuticals" (Rowman & Littlefield, 2012) is the result of a seven year investigation into the deadly world of ineffective medicines, which kill between 100,000 to a million people every year. The wide-ranging estimates show how little we know about the extent of the problem. In some cases the medicines are poorly made by inattentive or negligent manufacturers, in others, faux products containing chalk or road paint are sold by criminal gangs as life-saving hypertensives, antibiotics or TB medicines.

"Investigations show that at least one in ten medicines from emerging markets is of suspect quality." -Roger BateWhen I started my investigation in 2005, more than half of all countries had no legislation outlawing fake medical products. Convicted cocaine traders are punished by the confiscation of all their assets, and in some cases, by the loss of their lives. Yet the same traders caught selling fake TB or malaria medicine that might have killed a child, are often only penalized with a small fine. Traders in narcotics quickly realized that the fake drug business had the potential to reap huge profits while having inconsequential penalties. The problem appears to be growing, and over the past decade, more dangerous products have been found with each successive year. My own investigations show that at least one in ten medicines from emerging markets is of suspect quality.

The encouraging news is that in the past seven years, many countries have responded well. Even despotic Syria and human rights abusing China have begun addressing the problem. This is vital for China because my investigations suggest that it is the largest global source of dangerous drug products. Worryingly, Americans purchase over $1.5 billion worth of pharmaceutical products from China every year.

The vast majority of Chinese chemicals are effective and incredibly cheap. Boycotting Chinese pharmaceutical products would lead to severe drug shortages and rapid price increases for medicines in the United States. U.S. healthcare costs, already the highest in the world, would shoot through the roof if drug costs double. Poor and uninsured patients might be forced to forgo medicines they could no longer afford.

"Sooner or later, someone you know well will be harmed by a substandard or fake drug. It could easily be you." -Roger Bate

India, another major supplier to the U.S. market, is probably second only to China in the production of dangerous drugs. India, however, is also home to some of the cheapest and best generic drugs, so blanket efforts by the West to limit Indian pharmaceutical exports are met with hostility by Indian producers and American patient groups alike.

Domestic consumers and producers in China and India must demand better quality. The safety of U.S. consumers depends in part on the safety of Chinese and Indian products, and only Chinese and Indian consumers will be able to push through the kind of legislative reform needed to substantively improve medicine quality. Like China, India is moving to combat dangerous products with stricter laws and increased police action. In both cases, boycotts are not the answer-but neither is inaction.

In the U.S., the Food and Drug Administration carefully tests and monitors drug safety. U.S. companies themselves effectively test chemicals, yet the heparin incident demonstrates that a clever counterfeiter can fool screening systems.

Effective quality control in China and India will improve everyone's safety. But to accelerate improvement, I make one major policy suggestion: it is time to ratify a global treaty against the criminal producers of dangerous medicines.

It won't be easy to agree, it will take many years, but the lessons learned and the dialogue between antagonistic nations like Germany, Britain and U.S. on the one hand, and Brazil, India and China on the other, will be useful. Aiming for higher quality products should be universal, working out the problems is in everyone's long run interests.

Most of these "problems" are actually more perceived than real. While protectionism is always a risk, concerns largely amount to overhyped worries about domestic manufacturers losing out in export markets. The treaty won't be easy, but the first Hague Convention against Opium in 1912 - between the major nations of the world, including China - is a good precedent. If we can agree on laws to stamp out the trade in narcotics, where, after all, there is a persistent demand for the product, surely we can do it for fake medicines: products that nobody wants.

The humanitarian case to combat bad drugs is enormous. Patients with malaria or tuberculosis suffer enough even when their medicines work. But the health and safety of Americans is also at risk. Sooner or later, someone you know well will be harmed by a substandard or fake drug. It could easily be you. It doesn't need to happen.

Roger Bate is the Legatum Fellow at the American Enterprise Institute.  His book, "Phake: The Deadly World of Falsified and Substandard Medicines", will be published in March 2012. 

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