African AIDS Victims Losers of a Drug War
By Karl Vick
Washington Post Foreign Service
Saturday, December 4, 1999; Page A01
NAIROBI The body of Josphat Nyakundi features a concise history of the century's three great plagues and the world's responses to them.
Just below his left shoulder is the faint circle left by a smallpox inoculation. In the recesses of his memory lingers the taste of the sugar cube placed on his tongue with the drops that would protect him against polio.
And swimming in Nyakundi's spinal fluid--inflaming the lining of his brain, keeping him braced in his Nairobi hospital bed against the flashing pain that comes with the slightest movement--are rampaging cells of cryptococcal meningitis, an opportunistic infection that means he has AIDS.
But neither Nyakundi nor the other 22 million Africans infected with HIV, the virus that causes AIDS, can get the medicine they need. Medical advances that stalled the AIDS epidemic in the West are not reaching Africa largely because these countries and their citizens face a stark choice: buy drugs at their market price, far beyond the means of all but a few Africans, or risk trade sanctions by the United States for buying or developing generic drugs at lower prices.
Responding to this criticism, President Clinton, speaking to members of the World Trade Organization on Wednesday, announced that the government would show "flexibility" in granting countries the right on a case-by-case basis to obtain cheaper drugs during a health emergency.
But the government has yet to draw up the criteria for judging a country's claim, and it is not clear what impact the change may have. For now, even palliative treatments like fluconazole, which would give Nyakundi the strength to make his way home to die, remain out of reach.
"Developing countries say: 'You're asking us to comply with rules and regulations. These are our obligations. But what are our rights under globalization?' " said Joseph Saba, who headed the U.N. program testing advanced HIV treatments in Africa.
Access to drugs is more than a life-and-death issue on the continent that accounts for two-thirds of the world's HIV infections. With AIDS in Africa transmitted primarily through heterosexual sex, the disease already has hurt economic development. Some countries stand to lose a quarter of their populations to AIDS, which one observer noted "is wiping out the middle class as quickly as it's created."
In Nairobi, where an estimated 14 percent of the Kenyan capital's 3 million inhabitants are infected, the leading public hospital refuses to admit patients with AIDS-related meningitis unless they show up with the drug to treat it. The hospital has no supply of its own.
Clinton administration officials, in defense of the policy, have emphasized the importance of protecting patent rights in a pharmaceutical industry that invests heavily in research.
It costs about $500 million to bring a drug from idea to market, said Shannon S.S. Herzfeld, senior vice president of international affairs at Pharmaceutical Research and Manufacturers of America, a drug-industry trade group. "For every 15,000 compounds that you look at, three become medicines," said Herzfeld. "Of those three, one makes a profit."
But in the name of protecting patents overseas, he said, the drug companies may have pushed so hard that they risk looking like bullies.
Developing countries say they are only beginning to appreciate the public health consequences of joining the World Trade Organization, which many have done in the 1990s. Before joining the WTO, they could avoid the high retail prices charged by pharmaceutical companies, which historically have viewed their primary market as the Western nations where the price of drugs is typically covered by insurance.
If those prices were beyond the means of places like Africa, which accounts for just 1 percent of drug industry sales, poor countries were free to shop for generic equivalents sold for a fraction of the price by nations that did not observe international patent laws.
India, for example, makes a $2 version of fluconazole, the drug that the 42-year-old Nyakundi would take every day for his meningitis if his family could afford the $17 retail price charged by Pfizer Inc., which holds the patent.
But in joining the WTO, a country agrees to honor foreign patents and acknowledges it would face sanctions for dealing in generics produced before a patent expires. The thrust of the patent agreement, known by the acronym TRIPS, requires every country to pay full retail price. However, to countries facing a health emergency, the agreement held out a loophole: A desperate country could make (or commission) the drugs itself, provided it paid a negotiated royalty to the patent holder.
This do-it-yourself alternative, called "compulsory licensing," was intended as a lifeline. But in practice, any country reaching for it has been handcuffed by U.S. trade negotiators.
U.S. officials have explained that, although the United States signed the TRIPS agreement, they have regarded its provisions as a minimum standard, and the office of the U.S. Trade Representative has urged that countries follow a higher standard--payment of full licensing fees. In negotiations with individual countries, the trade representative can threaten the loss of U.S. trade if the nation goes forward with compulsory licensing.
The threat worked against Thailand last year: It dropped plans to produce the anti-AIDS drug ddI after U.S. officials threatened sanctions on key Thai exports.
And last year when South Africa, where one in 10 people is HIV positive, passed a law permitting the government to make drugs it deemed too expensive, U.S. Trade Representative Charlene Barshefsky reacted swiftly. At the urging of the U.S. pharmaceutical lobby, South Africa was placed on the "301 watch list," which is seen as a prelude to trade sanctions.
South Africa's case was buttressed when activists from the advocacy group ACT-UP began pushing the cause and found a target in the presidential campaign of Vice President Gore. After protesters repeatedly disrupted campaign appearances, Gore met privately with South African President Thabo Mbeki. On Sept. 17, the United States removed South Africa from the sanction watch list.
"My understanding is that any country can do what we said we're going to do," said Ian Roberts, an adviser to the South African health minister.
The U.S. policy has been attacked by humanitarian organizations, led by Doctors Without Borders, the Paris-based aid group that won the Nobel Peace Prize last month. Its campaign to broaden access to "essential medicines" recently gained a significant ally in the World Bank, which under President James D. Wolfensohn has put new emphasis on health care in the poor and emerging countries it is mandated to help.
Ok Pannenborg, the World Bank official who oversees health investments in Africa and the bank's purchase of up to $800 million a year in pharmaceuticals, said the drug-price structure "shows an increasing disconnect with the needs of the majority of the people in the world."
Calling the South Africa outcome "a symptom that times are changing," Pannenborg said the World Bank "is comfortable" with compulsory licensing and a second practice permitted under TRIPS, known as "parallel importing," or shopping abroad for the best retail price on patented drugs.
By supporting cheaper alternatives, Pannenborg said the pharmaceutical industry might be nudged toward a "tiered pricing" arrangement in which the West would pay one price for a drug, and developing countries another.
"I believe with all my heart that a way can be found to make money through numbers," said Kahama Rogo, president of the Kenya Medical Association. "It will not be a big margin, but it will be a profit."
Even if the drugs were available, African medical professionals acknowledge that most African countries lack the expertise and facilities to monitor the most sophisticated drugs, such as protease inhibitors and other ingredients in the "cocktail" that has extended the lives of AIDS patients in the West. But they say that making the drugs affordable would provide a strong incentive.
A U.N. pilot project is demonstrating it can be done. At six clinics in Uganda, HIV patients are taking combinations of two or three drugs for $220 to $673 a month, less than half of what Western patients pay, thanks to discounting arranged by the United Nations.
The therapy is proving roughly as effective as in the West, yet still remains beyond the financial reach of all but about 800 Ugandans. Even if the price fell to $100 a month, "cocktail therapy" would remain beyond the means of most people, said program coordinator Dorothy Ochola.
Subsidies from Western governments and aid groups might eventually make up the difference, she said. But for now, most patients focus instead on getting the drugs that help them manage the opportunistic infections that cause 80 percent of AIDS deaths.
Doctors say that is where high drug prices hit hardest in Africa. The meningitis that freezes Josphat Nyakundi to his bed is the third-leading cause of death in Kenya, behind two other AIDS-related ailments--tuberculosis and diarrhea. He took fluconazole until his family ran out of money, then landed back in the hospital while waiting for a friend who works for Kenya Airways to return from abroad, where many drugs are cheaper.
Christopher Ouma, the doctor who admitted him, said that at a public hospital where half the patients cannot pay the $2.60 daily bed charge, he usually does not even tell patients' families the drug exists.
"This is where the doctor's role goes from caregiver to undertaker," said Ouma. "You talk to them about the cheapest method of burial. Telling them about the drugs is always kind of a cruel joke."
Staff writers David Brown and John Burgess in Washington contributed to this report.