Dr. Andrew Azikiwe’s clinic in Nigeria’s capital, Abuja, is bustling. “I’m just like a Western doctor. Many of my patients have minor ailments,” he tells me as we walk through the crowded reception area into his office. But along with the broken bones and common colds, Dr. Azikiwe (I have changed his real name here at his request) sees more and more patients with malaria—a mosquito-borne disease that kills one million Africans a year.

Most Nigerians administer their own malaria treatment. They know the symptoms—high fever and aching joints. And they know the time-tested remedy—chloroquine, purchased from a local pharmacy or street trader. Unfortunately, chlo­roquine’s effectiveness has deteriorated as the malaria parasite has mutated and gained resistance to the drug. Chloroquine now fails most of the time it is administered.

The second line of defense includes stron­ger drugs with strange names and uneven track records. Complicating this new world of malaria treatment is a burgeoning industry of fakes, forg­eries, and pseudo-pharmaceuticals with suspicious provenance. A sick patient who has tried what she thinks is chloroquine, and who shows up at the doctor’s needing further treatment, now presents a puzzle—a dangerous and perplexing one.

Unfortunately, chloroquine’s effectiveness has deteriorated as the malaria parasite has mutated and gained resistance to the drug. Chloroquine now fails most of the time it is administered.

If what she took was an outright fake, made of chalk or aspirin (to which the malaria parasite is impervious), then she may yet respond to genuine chloroquine. But if she has taken a poor-quality copy or counterfeit that contains some chloroquine, but not enough to kill all the parasites, then only the newer, much more expensive artemisinin-com­bination drugs will do. In the worst case, a patient may have received a dose of artemisinin—say, in a diluted medicine with a phony label—that wasn’t strong enough to kill the parasite. Under those cir­cumstances, it may be too late for her.

The challenge faced by Doctor Andrew, as many of his patients call him, is both social and medical: a hardy strain of malaria and a corrupt, poor, and inconsistent health infrastructure that reinforce each other. The effects are disastrous for children under age five, who make up the vast majority of Africa’s malaria victims and require delicate care.

It’s a heartbreaking predicament. While researchers and pharmacologists around the world work on new drugs, their efforts are com­plicated by the murderous opportunists who fake legitimate products. In this environment, where every sale puts a patient’s life in peril, the market—encompassing tra­ditional commerce as well as financial aid and in-kind dona­tions—has broken down in the deadliest of ways. It doesn’t just distort prices and cause ineffi­ciencies, as one might expect with DVDs or Fabergé eggs. It kills children.

The World Health Organization (WHO) defines a fake or counterfeit drug as a medicine “which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and…may include products with the correct ingre­dients or with the wrong ingredients, without active ingredients, with insufficient active ingre­dients or with fake packaging.”

Make no mistake. Dilution can be lethal. Recall the scene in the classic 1949 film “The Third Man,” when the villainous Harry Lime, played by Orson Welles, explains to his friend from the top of a Ferris wheel why he has been stealing and dilut­ing penicillin: “Look down there,” he says, referring to people on the ground. “If I offered you £20,000 for every one of those dots that stopped moving for­ever, would you really tell me to keep my money, or would you start calculating how many dots you could afford to spend—free of income tax?”

Writing in the January 2007 issue of Tropical Medicine and International Health, pharmaceu­tical technology professor Magnus A. Atemnkeng and his colleagues estimated that 86 percent of understrength medicines analyzed in Kenya and Congo came from India and China. The reason that “most of the sub-therapeutic dosage drugs were manufactured in India and China may be because of the laxity of Indian and Chinese regu­latory bodies in checking exported medicines,” the authors write. Vietnam, Thailand, and Cambodia also are major sources of fraudulent drug manufac­ture. Nicholas White of Oxford University writes that over half the drugs sold in certain parts of Africa and Asia are esti­mated to be counterfeits.

Many of these products con­tain no active ingredients at all—one survey in Cambodia showed that over 90 percent of the fake antima­larials seized there contained nothing more potent than chalk. Most of the products tested in Africa do contain some antimalarial compounds, but in many cases not enough to prevent disease—the patient isn’t cured but the parasite has a chance to build up the ability to resist the therapy and pass on that resis­tance to new generations of parasites. Weakened versions of real malaria drugs can do a great deal more harm in the long term than totally fake ones.

Researchers estimated that 86 percent of understrength medicines analyzed in Kenya and Congo came from India and China.

Who makes the bad drugs? Some are deliberate perpetrators, faking the packaging and relabel­ing aspirin or chalk as an antimalarial. But other culprits are legitimate firms that are simply slack in their operations; with more effort, they might make a perfect copy of a malaria drug. Sometimes the entire firm is operating to unacceptable stan­dards; other times rogue employees work after hours to increase production and sell the drugs to criminal networks.

Processes like these probably created some—perhaps most—of the two dozen different types of antimalarial drugs I saw in the pharmacies of Lagos and Abuja. One typical pharmacist car­ried a range of old, outmoded drugs, plus some of the newer artesunate and artemisinin-combina­tion therapies (ACTs). Everything in the store may work, or not. We simply don’t know.

I couldn’t pick out the counterfeits in the phar­macies I visited. As a white face asking about malaria drugs, I was offered the most expensive treatments, with prices for a full course ranging from 1,250 naira to 1,750 naira ($10 to $14). The best treatment on the market is Coartem, an ACT produced by the Swiss company Novartis. It has been tested by EU and Swiss regulatory agencies and is pro­duced in both the United States and China. Of the 20 pharma­cies that my colleagues and I visited, 13 stocked Coartem, six had heard of it but did not stock it, and one claimed no knowledge of it whatsoever. But the drug’s high cost ensures low sales. Patients tend to opt for older, cheaper drugs, most of which are made in Africa without quality assurance. Such drugs are ineffec­tive even when they are made well.

Who makes the bad drugs? Some are deliberate perpetrators, faking the packaging and relabeling aspirin or chalk as an antimalarial. But other culprits are legitimate firms that are simply slack in their operations.

The main culprits in slowing the flow of Coartem appear to be officials within the Nigerian gov­ernment itself. The government promotes local production of antimalarials, a dangerous pros­pect. As one medical professional said, “When the desirables are unavailable, anything available becomes desirable.” The Lagos Health Ministry has stated that Nigeria will continue to produce drugs, including ACTs. It may test these drugs locally, but Nigerian companies have not sent any of their prod­ucts to be tested for quality by a competent agency, such as the U.S. Food and Drug Administration or its European or Japanese analogs, so we have no idea how effective these drugs may be.

The Nigerian Government support for local production is misguided but may explain why the free Coartem donated by the Global Fund—a taxpayer-supported procurement agency that fights HIV/AIDS, tuberculosis, and malaria—has failed to reach more than a few public hospitals. Widespread availability of Coartem would help drive substandard drugs, whether produced in Nigeria, China, India, or another country, out of the market. But even though the Global Fund had provided over $31 million of malaria support to Nigeria as of March, Coartem remains rare.

Sources at the Nigerian Ministry of Health tell me they themselves take Coartem if they contract malaria. But most Nigerians have little or no access to the medicine. While public hospital administrators told colleagues of mine they had received Coartem, it was in lower quan­tities than they had expected. And the government has never publicized its availability, so few patients ask for it. Some of the largest and best private hospi­tals in Lagos (such as Vineyard, Egbeda, Lago, Hamadia, Abule, and Egba) have received no free Coartem at all. Others either pur­chase the drug or buy cheaper copies of it.

Dr. Azikiwe showed me a drug called Salaxin, which, its packaging claimed, was produced in Belgium. But the paper in Tropical Medicine and International Health by Magnus A. Atemnkeng and colleagues at the Vrije Universiteit in Brussels identified Salaxin as one of a group of drugs stated to have been made by a Belgian company, which, in fact, “were all counterfeit as this company did not exist at the address mentioned on the packaging….this was confirmed by the Ministry of Health in Belgium.”

But it’s not just the manufacturers that bear the blame. Even some international aid agencies and donors, confident in their benevolence, sanction drugs that have not been tested for safety or for bioequivalence (that is, whether they are therapeu­tically the same as the patented drug from which they are supposed to be copied). The WHO had to withdraw 18 antiretrovirals from its HIV treat­ment campaign in 2004 because it could not be sure the drugs were up to standards (some of the drugs were readmitted once they were tested by the FDA and improvements were made to manu­facturing plants).

Africa will also have to address the distribution of drugs that have either lost their effectiveness or haven’t been tested by the best international agen­cies. A drug similar to Coartem is Coarsucam, which is an ASAQ—that is, a combination therapy of arte­sunate (AS) and amodiaquine (AQ). Coarsucam is produced by Sanofi-Aventis, a firm that has said it will not enforce its patent on the medicine in malarial nations. Sanofi has a reputation for producing reli­able mainstream drugs, but there are already some reports of increased resistance to AQ. As of April 20, the Global Fund had approved for use a total of 30 drugs for malaria—only two of which had been authorized by a “stringent regu­latory authority.”

Officials of aid organizations say they want to increase competition and lower drug prices, but they rarely take note of the counterfeit market their policies can encourage. For, as counterfeit expert Doug Clark of Lovells LLP in Shanghai says, no matter how low drugs are priced, producers of counterfeits can always sell them cheaper. The aid groups will soon have to get into the business of law enforcement if they truly want to save lives.

With U.S. taxpayers contributing nearly 35 per­cent of the Global Fund’s budget, Senator Tom Coburn, an Oklahoma Republican who is also a medical doctor, has started paying attention. “We cannot allow the world’s poorest, sickest, and most vulnerable populations to be made into guinea pigs through the purchase of medicines that are untested at best and counterfeit or toxic at worst,” he told me. “Why should wealthy nations, through support of the Global Fund, provide drugs to African children that we would never give to our own children?”

While international donors and pharmaceuti­cal companies like to talk about how much money they are giving to the poor or spending on research and development, neither group wants to discuss counterfeit and substandard drugs. A 2005 paper in the Public Library of Science’s medical journal criticized several large pharmaceutical companies for silence on counterfeiting. Critics say that some drug companies worry that publicity surrounding forgeries of their products can harm sales of legit­imate versions. Most of the time, however, large drug companies try to prevent counterfeits and alert authori­ties when they discover fakes.

'We cannot allow the world’s poorest, sickest, and most vulnerable populations to be made into guinea pigs through the purchase of medicines that are untested at best and counterfeit or toxic at worst,' said Senator Coburn.

One of the heroes of the fight against counterfeits is Dora Akunyili, a 52-year-old phar­macy professor who heads Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC). Akunyili has a personal reason for fighting counterfeiters: a friend of hers died from fake anti-diabetes drugs, and since then she has collected volumes of shocking tales. “People have been dying in this country from the effect of fake drugs since the early 1970s,” she says.

According to the WHO, before Akunyili took over in 2001, corrupt Nigerian officials both extorted money from legitimate drug manufac­turers and allowed counterfeiters access to the market. In 1995, when Nigeria tried to help neigh­boring Niger battle a meningitis epidemic, over 60,000 doses were distributed before the medi­cines were uncovered as fakes. Some 2,500 patients died as a result.

Before Akunyili took office, 68 percent of all drugs were unregistered and over 41 percent fake or substandard. The guilty faced minor penalties: 5,000 naira ($40) and only three months in jail. Most accused fakers never even saw the inside of a court, let alone jail, because they paid off officials and police.

But times are changing. Akunyili tells me that her team has convicted more than 50 coun­terfeiters, with as many cases pending. She has pushed for landlords of apartments where fake drugs are stored to be arrested. She shut down Bridge Head Market in the southeastern city of Onitsha in a March raid that netted more than 80 truckloads of counterfeit drugs with convincing labels. She says that counterfeiters invest mostly in packaging, the quality of the drug being largely immaterial to them. Just as important, awareness campaigns have had notable successes, and, in part because of tips from the public, two bil­lion naira ($16 million) worth of fake drugs was seized or vol­untarily handed over in 2005. The WHO reported in 2002 that 70 percent of drugs in Nigeria were fake or substan­dard; by 2004, that figure had fallen to 48 percent.

As I leave Dr. Azikiwe’s surgery ward, he wishes me well and tells me to watch my back: “There are many people who gain from the current climate, so don’t make yourself a target.” He was threatened when he exposed a dealer trying to sell fake drugs at his clinic. People have told him that he should be careful.

There have been attempts on Akunyili’s life; a bullet grazed her head in an attack in 2003. One reason that the danger has increased is that pun­ishment for fake drug operations in Nigeria has been increased to rival that for dealing in narcot­ics—and organized crime fights dirty.

Law enforcement officials and doctors can’t solve the problem themselves. They need help from busi­nesses, aid agencies, and governments so that fake medicines become an occasional annoyance, rather than a persistent and fatal threat.

Roger Bate is a resident fellow at the American Enterprise Institute. He researches in Africa frequently.

Image credit: photo by flickr user christopher.vanbelle.