Drug Safety Watchdogs Needed Worldwide

Something like 90 percent of all the sick people in the world at any given moment – aka the “global burden of disease” — live in poor countries. Most drugs and vaccines are made for and used by the rich world.

In the last decade, the international community has responded to this inequity with a number of grand initiatives aimed at improving access to many medications in the developing world.

But drugs and vaccines don’t always work the way they are supposed to work. Some are just bad products. Good drugs often vary in performance in different people, or different parts of the world. Many get misused, due to lack of proper diagnoses or lack of basic information. And sometimes the donations are not motivated by the most charitable of impulses.

Drug Watchdogs Andy Stergachis and Alex Dodoo

“Some donated drugs are the ones nobody else wants and that drug companies are trying to get rid of,” said Alexander Dodoo, a pharmacologist from the University of Ghana Medical School who is pushing for better monitoring of drug safety and efficacy in the developing world.

Dodoo and a local colleague in this endeavor, UW epidemiologist Andy Stergachis, spoke earlier this week in Seattle to promote the practice of “pharmacovigilance.”  Stergachis and his UW colleagues are world leaders in this field (which, frankly, could use a better name) and are already working on this problem in a number of countries in Africa and Asia.

In the U.S., we have an extensive (and expensive) system of clinical testing and regulation that is supposed to assure safety and efficacy — but still often fails.

The anti-arthritis drug Vioxx, for example, was recalled in 2004 after wider use revealed it raised the risk of heart attack and stroke. A batch of the blood-thinner Heparin was recalled in 2008 only after the FDA began investigating reports of deaths and injuries. It turned out that a tainted and counterfeit ingredient had been supplied to its manufacturer, Baxter, by a Chinese pharmaceutical firm. Last fall, nearly a million swine flu shots were recalled when it was discovered they had lost potency.

Such problems have led to the call for a much more robust and aggressive system of “post-market approval” monitoring of drugs – aka pharmacovigilance — in the U.S.

The need is even greater today in the developing world because many poor countries have nothing like the FDA or any kind of system for monitoring the performance of medicines. Combine this lack of monitoring with the flood of new medications now being donated and the risks increase markedly.

Dodoo told a story about a potent anti-malaria drug, called LapDap, developed by a European drug company and promoted by health officials in Ghana. Once put into wide use, it ended up causing serious side effects. Dodoo said later analysis showed an estimated 20 percent of Africans had a genetic variation that made the drug toxic given their different metabolism. The episode prompted public outrage, he said, and generated mistrust of the government’s anti-malaria campaign.

“We have to recognize that the information about safety gained during drug development (i.e., clinical testing) is always going to be incomplete,” said Stergachis. Today’s major health campaigns are courting disaster, he said, if they expand developing world access to medications without better safety monitoring in those countries.

Tom

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