Poor medicine for poor people

Roger Bate | 16 May 2008
Globe and Mail
New field research shows that a third of anti-malaria drugs collected in six African cities fail at least one quality test, and aid agencies continue to fund untested, substandard drugs. The World Health Organization suggests that one-fifth of the approximately one million children who die every year from malaria die because of substandard and poorly prescribed medicines.

This is poor medicine for poor people.

In a sample of anti-malarial drugs sold in six African countries, researchers from my advocacy group, Africa Fighting Malaria, found that 32 per cent of those produced in Asia and 48 per cent of those made in Africa failed basic quality tests, as described in a paper published last week in PLoS ONE, the U.S. Public Library of Science peer-reviewed medical journal.

Fake medicines are an increasing problem in richer countries, too. Contaminated Chinese heparin may have caused the deaths of 81 Americans; fake Viagra, cholesterol drugs and painkillers have become increasingly prevalent across North America and Europe.

But while the U.S. Food and Drug Administration, the WHO, Interpol and European health and law enforcement agencies are doing their best to crack down on the major counterfeiters, taxpayer-funded aid agencies — including the Global Fund to Fight AIDS, Tuberculosis and Malaria — are still financing sales of untested, and often poor, medicines to poor people.

Nirj Deva, member of the European Parliament for the South East of England as well as the British Conservative Party's spokesman for international development, asked the European Commission in March why it was funding medicines in the developing world "that would not in any instance be approved for use on EU citizens?"

Louis Michel, the Commissioner for Development and Humanitarian Aid, provided a long-winded answer in which he acknowledged that "stimulating competition" to lower drug prices was the main reason, although he made no mention of the local tariffs that inflate those prices in many poor countries.

U.S. taxpayers support roughly a third of the Global Fund's budget — close to a billion dollars a year—but no legislator there has asked why American tax dollars are buying untested drugs, even though these drugs can endanger the people they were purchased to help. Canada, too, is among the top 10 contributors to the fund.

The practice may not actually lower prices — German aid agency GTZ has reported that drugs produced locally in Ghana are often more expensive than imports from India, China, or Europe. And their effectiveness is even more debatable. The Global Fund requires only that the drugs come from facilities that can show good manufacturing practices, which means, in effect, that a company that can produce aspirin is considered acceptable for producing more complex, and potentially harmful, anti-malaria drugs.

A generic drug sold to Westerners must pass bioequivalence testing to demonstrate that it actually mimics the original drug. But the Global Fund does not demand proof of bioequivalence for drugs on its approval list.

Although half our sample of African-produced medicines failed quality tests, health activists continue to promote local production, and importation from underregulated Asian producers, to increase the availability of medicines in Africa.

Certainly, some African countries, and the better producers of India and China, are capable of manufacturing safe medicines. And it is not clear how many of the drugs we tested are actually being procured by the Global Fund.

But even if no poor-quality drugs are actually procured by the Global Fund, simply listing them as acceptable sends a bad signal. All the drugs we tested were listed on the national registries of the countries in question, highlighting these countries' inability to police their own lists. In India, which has no national drug regulatory authority, individual states license generic manufacturers, sometimes for export only. Exporters need not even comply with the weak local standards.

The Global Fund denies there is a problem. The most recent board meeting, in April, did not deal with it, which means no action until at least the next meeting in November.

This policy is harming African children by endorsing substandard products with taxpayers' money. The children can't fight back, and bureaucrats don't seem interested — it's time for taxpayers to start complaining.

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