Nigerian Regulator Dodges
Violence to Fight Fake Drugs

Dorothy Akunyili Speaks Out
Against Bogus Medicines
And Makers Lash Back

Bonfire of the Remedies

May 28, 2004; Page A1

LAGOS, Nigeria -- As Dorothy Akunyili was being driven through her village in late December, a hail of gunfire erupted around her car. A bullet grazed her head, but she was otherwise unhurt. The police have since arrested 16 people for allegedly trying to assassinate Ms. Akunyili. Her bodyguard detail has been doubled.

Why is Ms. Akunyili a target? As head of the National Agency for Food and Drug Administration and Control, the Nigerian equivalent of the U.S. Food and Drug Administration, Ms. Akunyili has spent three years waging an increasingly successful war against one of the biggest health scourges of the developing world: counterfeit pharmaceuticals.

The campaign has put Ms. Akunyili, known as Dora, in a precarious position. The fake-drug suppliers she's attacking are among Nigeria's wealthiest businessmen. Police investigating the December incident say local drug distributors hired contract killers to murder her. Since then, in separate incidents, suspected arsonists have destroyed a lab at Nafdac, as the agency she heads is known, and gangs gutted its administrative building.

Ms. Akunyili, though, is driven by memories of a personal tragedy. She says her 21-year-old diabetic sister, Vivian, died in 1988 because of a fake-insulin injection.

So her campaign continues. Under her watch, Nafdac has shut down hundreds of domestic importers of counterfeit drugs and exploited the country's weak laws to expand Nafdac's enforcement powers. She has turned fake drugs into a national issue by burning impounded drugs in public, and has even used high-school essay competitions to publicize the dangers of substandard medicines.

Fake pills often contain a small portion of the real active ingredient in medicines, but not enough to be effective. Common products include counterfeit versions of antibiotics and medicines for malaria, high blood pressure, asthma and diabetes. Some are made of sugar or chalk. Others are made so cheaply that they are ineffective or dangerous.T

Fake drugs can kill. They do so with harmful ingredients or because they deprive patients of proper treatment. Either way, they pose a big international problem, representing as much as $50 billion, or 10%, of the $500 billion in medicines sold globally each year, according to estimates by Kristina Lybecker, an economics professor at Drexel University in Philadelphia. Developed countries aren't immune, with Britain and the U.S. reporting scandals last year involving sales of bogus versions of Viagra and Lipitor, Pfizer Inc.'s hit cholesterol drug.

But Ms. Akunyili's campaign is a model for particularly vulnerable developing nations. Thailand's government estimates that fake medicines account for 8.5% of that country's drug market. The Cambodian government says 13% of the drugs circulated there are counterfeit. A recent World Health Organization survey of seven African countries showed that between 20% and 90% of antimalarial drugs failed quality testing.

This can discourage investment that is critical to development. According to Nafdac, some big drug makers have moved operations out of Nigeria -- a nation of 134 million people -- partly because cheap counterfeits undercut their own drugs. One of the biggest that stayed, GlaxoSmithKline PLC, suffered. Counterfeit versions of Glaxo's pain-relief medicine, Panadol, were so cheap and plentiful in 2001, for example, that Glaxo stopped making the drug in Nigeria for the entire year.

"Those were dark days," says Osaretin Jaiyeola, head of regulatory affairs for Glaxo in Nigeria. "But we had faith that one day there would be sanity in the system. That's paying off."

Signs of Progress

Since Ms. Akunyili took office three years ago, Nigeria's level of fake drugs has fallen to 35%, down from around 70% in 2001, according to Nafdac studies. That is renewing some confidence among foreign investors. Sales volume for Panadol and Glaxo's antimalarial Halfan doubled in 2002 compared with the previous year. But it remains a struggle. Panadol sales fell again last year by 20% after counterfeiters copied a hologram that Glaxo had put on its packaging as a defensive measure.

The health benefits -- including what Nafdac says is a sharp drop in kidney failures linked to the use of fake drugs -- have caught the attention of neighboring countries. Ghana's government has begun mimicking Ms. Akunyili's model, holding public burnings of confiscated medicines while banning imports from companies already blacklisted by Nafdac.

The clampdown has come at a personal cost to Ms. Akunyili, 49 years old. Nicknamed "the Iron Lady" for her large frame, tough talk and taste for bold jewelry, she describes the counterfeit-drug business as "an evil that needs to be fought."

But she doesn't go out anymore unless accompanied by bodyguards. She eats only home-cooked food, for fear of being poisoned. A police car and a fire engine are permanently parked outside her office door. "I feel trapped," she says.

Julius Ihonvbere, a special adviser to Nigeria's president, acknowledges the predicament she is in. "We may have exposed her," he says. "Maybe this is the price we have to pay."

Ms. Akunyili trained as a pharmacologist and wrote her doctoral thesis on a local herb that's used to treat cobra bites. She taught at a university and did a brief stint in local government. Her work caught the eye of Nigeria's president, Olusegun Obasanjo, who asked her to head Nafdac in April 2001. Her main mission: shut down the counterfeiters.

Some criticized the president's choice, noting that most Nigerians involved in the fake-drug trade belonged to Ms. Akunyili's own tribe, the Igbo. "They said I wouldn't be able to face my own people," she recalls, during an interview at her office in Abuja, Nigeria's capital.

She took over Nafdac when Nigeria's pharmaceuticals industry was a mess. Fake, substandard and expired medicines were sold openly in pharmacies, outdoor markets and even on public buses. Because of a particularly brisk trade in bogus antibiotics, some bacterial strains had developed resistance, reducing the effectiveness of even genuine drugs. Ms. Akunyili says there is no law in Nigeria that regulates the distribution of prescription drugs. "It's part of the problem," she says.

Some West African countries, including Ghana and Sierra Leone, refused to import Nigerian drugs, though in late 2002 both lifted those bans because of the success of the Nafdac clampdown.

Local drug distributors offered bribes to Ms. Akunyili during her first three months at Nafdac, hoping she would allow their imports to enter the country. This is the standard practice in Nigeria, but she refused, she says. After that, she began to receive death threats by phone. Objects used in local witchcraft ceremonies were left on her desk, including a dried tortoise and chicken feathers dipped in blood. A month later, six armed people showed up at her house, but Ms. Akunyili was away.

Ms. Akunyili took aim at the main source of the problem: underground manufacturers in India and China who export fake medicines to Nigeria. According to Nafdac, a Nigerian counterfeiter would typically travel to one of those countries, pass on a sample of the medicine to be copied and ask that it look, smell and taste like the original. When legitimate companies introduced holograms on their packaging, those were copied too.

In winter 2001, Ms. Akunyili attended an Indo-African health summit in Bombay. Ms. Akunyili, addressing the conference, warned that unless the Indian government cracked down on underground drug exporters, "we'll be forced to change the trade relationship in a way that's not palatable to you," she recalls saying. "I didn't even have the power to make that threat," she now adds.

Though it took several months, the gambit worked. By June 2002, the Indian government had approved Nafdac hiring independent analysts in India to certify the authenticity of Indian drugs exported to Nigeria. Similar efforts in China weren't as effective. "The independent analysts there are not as dependable," she says.

Back home, Ms. Akunyili set about strengthening Nafdac by creating a new "enforcement arm" that worked closely with local police. In 1999 and 2000, before Ms. Akunyili came on board, Nafdac carried out 68 investigations. In 2002 alone, the agency conducted 209 and closed hundreds of distributors and manufacturers.

Ms. Akunyili, initially hampered by Nafdac's limited legal power, began issuing "administrative guidelines" and applying them with greater force than ever.

One new guideline forced drug companies, as well as the banks that financed their operations, to account for import transactions before goods were released. Another required even registered manufacturers like Glaxo to surrender expired medicines, so that they could be destroyed. Foreign airlines were warned that if any of their planes were used to transport fake drugs into the country, they'd be grounded.

Not everything went her way. In December 2001, Nafdac issued a guideline stating that any pharmacy selling even a single unregistered drug would automatically be shuttered. When hordes of pharmacists and other drug vendors objected, the deadline was moved to the end of 2002, then to June 2003, and then to December last year. But it has yet to be enforced.

'Drug Marts'

Ms. Akunyili also wanted to replace Nigeria's three huge outdoor drug bazaars with modern "drug marts," each housing scores of vendors in a clean, closely-monitored building. The government appropriated some $5.7 million for the project, but pharmacists lobbied against the plan and killed it.

Nafdac charged on, beefing up customs surveillance at the country's main ports and streamlining the drug-registration process. It performed surprise checks on drug makers' factories. Those that failed to meet agency standards were fined as much as $3,500 or closed.

Most countries tend to destroy confiscated medicines far from public view, but Nafdac organizes its "destruction exercises" as media events. In the past three years, the agency has held 75 such exercises and incinerated fake medicines valued at more than $45 million.

A small crowd of onlookers and journalists recently gathered in the middle of the biggest garbage dump in Lagos. As the cameras rolled, a Nafdac official handed out press releases, made a brief speech and then set fire to a 20-foot-high heap of confiscated medicines. Among the bogus drugs were knockoffs of Diflucan, a yeast-infection drug made by Pfizer, and copies of Septrin, an antibiotic made by Glaxo.

The consignment burned for several hours, destroying more than 15 truckloads of useless medicines worth about $1 million on the street. To discourage looters, armed police stood guard on nearby piles of rubbish, and as black smoke rose skywards, blister packs, bottles and ampoules exploded like firecrackers.

Nafdac agents constantly prowl Nigeria's three major drug markets, where hundreds of suppliers sell to retail and wholesale buyers. One foray in March yielded a big fish, a 35-year-old supplier named Charles Okeke. Mr. Okeke was arrested for allegedly importing from China large quantities of fake Halfan, the Glaxo medicine.

While a police officer stood guard, Mr. Okeke insisted that he had given himself up voluntarily. "I have a conscience," he said. Dioka Ejionueme, Nafdac's director of enforcement, saw it differently. "The heat got too much for him," he concluded.

Lately, the counterfeiters have responded with unprecedented force. In 2002, a gang destroyed a Nafdac lab. Then, in March, fire struck the agency's administrative building in Lagos. It raged through the night and gutted the 11-story structure, destroying computers and vital records.

Two days later, another fire razed a Nafdac lab not far from Abuja. Agency officials suspect the fires were started by criminal gangs linked to counterfeiters. So far, the police have made no arrests.

Now, Ms. Akunyili worries that when her tenure at Nafdac ends in April, 2006 and she no longer has government bodyguards, she may have to flee the country. "I have ruined people's businesses," she says. "The bitterness is very deep."

Write to Gautam Naik at gautam.naik@wsj.com1