The Wrong Message in a Bottle

Roger Bate | 15 Nov 2008
New York Times
In late September, the authorities in Belgium seized more than two million counterfeit painkillers and antimalarial drugs that had been manufactured in India and were en route to Africa. It was the largest seizure ever of fake pharmaceuticals in Europe.

The incident shines a light on one of the most pressing problems in delivering life-saving medicines to the world's poorest patients: the proliferation of low-quality and counterfeit products, many of which are dangerous. If aid organizations are serious about combating the spread of deadly diseases in the developing world, they must do more to ensure the safety and quality of drugs.

Thirty percent of the world's population lacks access to essential medicines, according to the World Health Organization. In some Asian and African countries, the number is as high as 50 percent. And this problem cannot by solved by supplying bogus medicines.

"Better to have lack of access," Dora Akunyili, the head of Nigeria's drug watchdog agency told me, "than access to counterfeits and substandard medicines." In 1988, Ms. Akunyili's sister died from taking fake insulin to treat her diabetes.

Imports of bad medicines like those seized in Belgium are only part of the problem. To deal with the scarcity of drugs, many poor governments have turned to local production. The international aid community has generally approved this move, because local manufacturing expands the supply, cuts down on transportation costs and creates jobs. But local producers often make low-quality drugs.

In Senegal, a 2002 study found that 21 out of 22 samples of the antibiotic ampicillin (of unknown origin) lacked the active ingredient and appeared to contain only flour. Thirty-eight percent to 52 percent of artesunate pills (an antimalarial drug) in Southeast Asia have been found to contain no active ingredient. The W.H.O. estimates that 20 percent of the Indian drug supply is either fake or adulterated. And one of my own studies found that 35 percent of malaria drugs in Africa are substandard.

That such a large share of the developing world's drug supply is subpar should come as no surprise. Even countries with stringent regulatory systems sometimes turn up bad pharmaceuticals.

Just this year, at least 95 Americans died after taking heparin (a blood thinner) manufactured in China that had been contaminated with oversulfated chondroitin sulfate, an inexpensive substance that mimics heparin in basic chemical tests. And in September, the F.D.A. blocked the import of more than 30 drugs made by the Indian company Ranbaxy, citing its failure to meet acceptable manufacturing standards.

The W.H.O. keeps a list of essential drugs, and its Drug Prequalification Program does its best to keep a separate list of safe suppliers of these drugs, which aid organizations refer to when buying medicines for developing countries. But this list is both short and unreliable; in 2004, several H.I.V. drugs produced by Indian drug companies were taken off the list because of insufficient evidence that they were effective.

Many poor countries now allow local drug makers to produce cheaper copies of patented drugs through what are called "compulsory licenses." But this strategy has led to the manufacture of poor-quality medicine. Thailand has issued many compulsory licenses to enable a state-financed company, the Government Pharmaceutical Organization, to make various patented medicines, including antiviral drugs used to treat AIDS. But the drugs it has made have been of such poor quality that the Global Fund to Fight AIDS, Tuberculosis and Malaria stopped buying them.

Many poor countries lack the regulatory structure needed to monitor safety and effectiveness. Some do not even have laws against selling substandard drugs, and none have sophisticated agencies like the F.D.A. with the trained inspectors and laboratories needed to analyze pharmaceuticals. It is essential that poor countries establish the laws, agencies and scientific capacity they need to oversee drug manufacturing and conduct random checks on imports and local drugs.

There are three things that aid organizations could do to help: They should give technical and financial support to governments' sincere efforts to maintain strict drug inspection standards. They should always refuse to subsidize any low-quality drugs. And in countries that consistently fail to ensure that locally produced pharmaceuticals are safe and effective, aid agencies should insist that only brand-name and generic products approved by stringent drug agencies like the F.D.A. be distributed.

Since taking over drug quality control in Nigeria seven years ago, Dora Akunyili has reduced the amount of substandard pharmaceuticals to 16 percent, from more than half. And if Nigeria can improve drug quality so drastically, other countries can, too. Thousands of lives depend on their efforts.

Roger Bate, a director of the health advocacy group Africa Fighting Malaria, is the author of "Making a Killing: The Deadly Implications of the Counterfeit Drug Trade." He is also a resident fellow at the American Enterprise Institute, which receives some support from pharmaceutical companies.