Offer to Africa On AIDS Drug

PARIS - In a move with the potential to start a worldwide price war over AIDS drugs, an Indian pharmaceutical company offered Tuesday to supply the triple-therapy AIDS cocktail for free distribution in Africa at $350 a year per patient. The offer was made by Cipla of Bombay, one of the world's largest manufacturers of generic drugs, to Medecins Sans Frontieres, the French doctors group awarded the Nobel Peace Prize in 1999 for its work in war-torn and impoverished areas.

Any African government that wants to buy large quantities of the drugs through Medecins Sans Frontieres will be able to do so for $600 a year per patient, which is about $400 lower than the price offered by the major Western pharmaceutical companies that hold the patents, Cipla said. "This is the way to break the stranglehold of the multinationals," said Dr. Yusuf Hamied, chairman of Cipla, who will meet with the doctors group on Feb. 15 to discuss strategy.

Medecins Sans Frontieres, the Philadelphia and Paris chapters of the anti AIDS group Act Up, and the Consumer Project on Technology, a Washington based organization started by Ralph Nader, have been mounting an aggressive joint campaign for the last two years to force major pharmaceutical companies to cut prices on all life-saving drugs for the world's poorest patients. The average cost of the AIDS cocktail in the West is $10,000 to $15,000 per year.

Last May, five multinational drug companies, with the sponsorship of the World Health Organization and other United Nations agencies, offered to sell their components of the cocktail to impoverished nations at reduced prices. But the country-by-country negotiations have gone slowly; so far, only Uganda, Senegal and Rwanda have agreements. The companies refuse to release figures, but the cost of a typical cocktail in Senegal was $1,000 a year, a representative of the doctors group said.

Makers of generic drugs in India, Brazil, Thailand and other countries are not part of the process, and Cipla's offer is a first shot at undercutting it. Cipla is offering to sell the doctors group as many doses as it is wants at $350 a patient per year. Dr. Hamied said his company would lose about $150 per yearly dose at that price, but he promised to supply "10,000 doses or 20,000 or 30,000, however many they want." The $600 per yearly dose African governments would pay represents Cipla's break-even price when overhead is figured in, which Dr. Hamied does not do on below-cost donations like the $350 offer, he said. Plans to distribute the AIDS cocktail widely in Africa are controversial.

Some health experts argue that the money would be better spent on problems like clean water and malaria control, and that AIDS budgets are better spent on condom distribution than on expensive drugs whose use needs to be carefully monitored.

But Medecins Sans Frontieres argues that the danger of the drugs pales beside the immensity of the epidemic itself and that Western testing standards are overcautious. The typical AIDS cocktail is a combinations of any three of about nine protease inhibitors or reverse transcriptase inhibitors. The chemicals suppress HIV, the virus that causes AIDS, but are toxic and can damage the liver. In the West, doctors carefully monitor the levels of the drug in the blood, test for organ damage and check the levels of the virus in the bloodstream. If the virus mutates to resist the therapy, the combinations are changed.

Careful monitoring may not be possible in many African settings, and the three drugs presently offered by Cipla will not allow easy changes in therapy. But with an estimated 25 million Africans infected with the virus, Medecins Sans Frontieres and other agencies argue that imperfect treatment is better than none.

The drug combination offered by Cipla contains six tablets: two each of stavudine, lamivudine and nevirapine. In the United States, Europe and many other countries, Bristol-Myers Squibb holds the patent on stavudine, which is known by the brand name Zerit; Glaxo Wellcome holds the patent on lamivudine, also known as Epivir, or 3TC; and Boehringer Ingelheim of Germany holds the patent on nevirapine, also known as Viramune. Dr. John Wecker, head of Boehringer Ingelheim's efforts to negotiate cheaper prices in Africa, said he did not yet know what his company would do if Cipla undercut its prices. "We offer a standard quality from the original manufacturer and can meet any demand that exists out there that can be delivered with safe procedures," Dr. Wecker said.

He refused to say at what price Boehringer Ingelheim sells nevirapine to Senegal or Uganda. "I could talk to you about antitrust laws, or about price signaling or about competitive reasons," he said, adding that "affordability is an issue, but not the major issue." Representatives from Glaxo Wellcome and Bristol-Myers did not return phone calls. But Western drug companies have shown a determination to defend their patent-holders' rights to be sole distributor throughout the world, even if patients go without life-saving drugs.

Late last year, Glaxo-Wellcome threatened to sue Cipla when it tried to sell Duovir, a generic version of Glaxo's Combivir, a anti-AIDS drug combination, in Ghana. Even though the head examiner for the African regional patent authority ruled Glaxo was in the wrong, Cipla backed down and stopped selling Duovir.