Executives at Gilead Sciences Inc. thought they were doing a good deed in 2002 when they announced a plan to provide their AIDS drug Viread to developing nations at a sharply reduced price that would yield no profit to the company.

Since then, however, Gilead's drug "access" program has been snarled in a string of bureaucratic snafus and miscalculations. Launched in April 2003, the program provided antiviral medication to only about 50,000 patients as of the first quarter of this year. Some AIDS activists have vilified Gilead over the slow start, accusing it of basking in good publicity while dragging its feet.

The simmering controversy over Gilead's access program illustrates how even the best of corporate intentions can run afoul of conflicting interests when it comes to the world's AIDS crisis.

Activists have long criticized drug companies for the high cost of their AIDS treatments and their efforts to block generic-drug makers from marketing cheaper versions overseas -- particularly in Africa, the epicenter of the AIDS epidemic. To counter that image, many companies have set up programs in which they donate AIDS drugs or make them available at cost to poor nations -- only to sometimes find themselves still catching flak for these initiatives.

Other big drug companies have routinely come in for such criticism. Doctors Without Borders recently blasted Abbott Laboratories for failing to provide sufficient access to a heat-stable version of its AIDS drug Kaletra outside the U.S., saying the company has been too slow in seeking approval for the drug around the world. Similarly, the organization criticizes GlaxoSmithKline PLC. for charging a high price -- now roughly $625 a year -- in the developing world for its drug Ziagen. Abbott says it is working "as quickly as possible" to get the new version of Kaletra to developing-world patients. Glaxo, meanwhile, notes that it recently cut the price of Ziagen by 28 percent.

Gilead officials admit many mistakes in conceiving their access program, although they deny slowing its implementation. Gilead research chief Norbert Bischofberger says he was surprised at the reception to the Viread program in many developing nations. "We were under the assumption that, 'We're giving you the drug at no profit, selling it at no cost, and you should be happy to receive it,'" he says. "We found it's not how it works in these countries."

Few drug companies have launched an access program at such an early stage or with so little infrastructure in place as Gilead. In December 2002, the Foster City, Calif., company was still unprofitable, with Viread having won approval just a year earlier. Yet the company announced a sweeping plan to provide Viread to 68 poor nations at cost. (It was later extended to 97 countries.)

John Martin, Gilead's chief executive officer, says the program represented the company's determination not to profit from drug sales in poor nations and to help stem the epidemic where it is most severe.

Unlike many larger drug companies, Gilead had no subsidiaries or distributor relationships throughout the developing world, and no desire to establish that infrastructure. Instead, the company turned to Axios, an Irish firm that runs similar access programs for other AIDS-drug makers.

Gilead and Axios opted to sidestep the cumbersome process of seeking regulatory approval for Viread in more than five dozen nations. Instead, they decided to make the drug available to developing countries via special "import waivers." Clinics or nongovernmental organizations could petition their government for special permission to import the drug, which would allow Gilead to ship it from the U.S.

To prevent "no-profit" versions of Viread from making its way back to major commercial markets and being sold -- a year's supply of the drug costs roughly $5,300 in the U.S. versus the current no-profit price of $200 -- Gilead produced an "export version" of the drug. The new pills were identical to commercial Viread, but were white instead of pale blue. Gilead then sought and received special Food and Drug Administration approval of the export version, hoping to assure governments in the developing world of the drug's safety.

From the start, however, the program ran into unforeseen obstacles. Health authorities in many targeted countries balked because Viread wasn't on a World Health Organization list of "essential medicines," which many nations considered a more useful guideline than FDA approval. Last year, Gilead compounded that error by missing a WHO deadline to get on the list, and now must wait until next year to try again.

The import waivers also proved unwieldy. Some nations were unwilling to grant waivers for unapproved drugs like Viread, while others insisted on separate applications for every patient treated. Sometimes even approved special imports were subject to tariffs that could double the cost of the drugs.

Participation languished. By early 2004, only 130 patients were receiving Viread through the program. A year later, that number had crept up to 7,600.

Frustrated with the import-waiver program, Gilead brought the access program in-house in early 2005 and decided it would seek approval for Viread and a second AIDS drug called Truvada around the world. Such approval would allow Gilead to sell its drugs through local distributors. But the abrupt shift introduced new strains, not least because it meant translating and reorganizing enormous FDA-approval applications for dozens of governments, some of which don't even have formal procedures for approving new drugs.

One African nation wrote back to the company months later, asking it to make its application "shorter," but without suggesting how. Many others failed to respond at all, requiring a small team of Gilead employees to follow up, often in person. So far, only 13 of the 97 countries now covered by Gilead's expanded program have approved Viread. Truvada is approved in eight of those nations. At the moment, Gilead's main goal is simply to complete its filings by the end of this year.

In February, health activists at Doctors Without Borders accused Gilead of "false promises" for failing to make the access program work. A few months later, the group added another complaint, criticizing Gilead for seeking a patent on Viread in India, a nation not included in Gilead's access program. The activists said a Viread patent could prevent generic manufacture of the drug through 2018.

Gilead says its policy is not to seek or enforce patents on its drugs in access-program nations. The Indian patent, the company says, is mainly necessary to prevent that nation's generic-drug makers from selling copycat Viread in "middle-income" nations such as Brazil and Thailand, where Gilead hopes to set prices higher than the no-profit level.

In fact, Gilead officials say they are actively seeking to license Viread and Truvada to generic companies willing to restrict their sales to India and the 97 countries in Gilead's access program. It hasn't yet signed any such deals in India, although Gilead does allow Aspen Pharmacare Holdings Ltd., a South African manufacturer, to make and sell Viread and Truvada throughout Africa.

Even once the bureaucratic hurdles are overcome, it's still not entirely clear how much Gilead's access program will help the poorest nations. Even after two price reductions thanks to improved manufacturing efficiency, no-profit Viread is still more expensive than a generic "triple-combination" AIDS drug available throughout the developing world.

Nevertheless, some activists view Gilead's efforts sympathetically. Bob Huff, who works with Gay Men's Health Crisis in New York, says that while he's concerned about some aspects of the program, including the speed with which Gilead is seeking approval of its drugs around the world, "I see goodwill on their part. ... It's just unfortunate that it's taken so long."