W.H.O. MOVES TO MAKE AIDS DRUGS MORE ACCESSIBLE TO POOR WORLDWIDE

By Donald McNeil Jr.

New York Times 23 April 2002

Paris -- Helping clear the way for Western-style AIDS treatment to reach even rural Africa, the World Health Organization released new guidelines today describing the drug cocktails that work best and the simplest acceptable laboratory tests for patients.

The guidelines are meant to show doctors in poor areas how to prescribe powerful "triple-therapy cocktails" safely.

In addition, the W.H.O. today added 12 antiretroviral drugs to its essential drugs list to encourage price competition between patent-based and generic companies and prod the latter to make more three-drugs-in-one-pill dosages.

The two moves are "vital steps in the battle against the AIDS pandemic and should encourage both industrialized and developing country governments to make H.I.V. treatment more widely available," said Dr. Gro Harlem Brundtland, the director-general of the health organization.

Carmen Perez, pharmaceutical director for the Doctors Without Borders campaign to make drugs cheaper, called today's W.H.O. decision a "very good victory."

The moves "show that treatment can be done," she said. "It will be difficult, but what can we do about that? There are 40 million infected people out there. There are no excuses. We're already late."

The health organization's announcement is also meant to silence several sets of critics: drug industry executives who have argued that triple therapy is too complex and dangerous for poor, illiterate patients; AIDS skeptics like President Thabo Mbeki of South Africa who argue that the drugs don't work or are toxic; and experts who confuse public health doctors in poor countries by overwhelming them with competing drug combinations.

Of the 40 million H.I.V.-positive people in the world, about 6 million are sick enough to need antiretrovirals now, the health organization estimates. Less than 5 percent get them because of the drugs' cost and the costly tests used in the West to monitor them. Some tests like CD-4 cell and viral load counts cost up to $1,000 and require equipment unheard of in rural clinics. The health organization hopes that, by 2005, if African and Asian health systems can stand the strain, up to three million people will be getting treatment.

It recently convened 100 AIDS doctors from 30 countries to come up with four tiers of minimally acceptable tests, said Dr. Basil Vareldzis, who helped write the new guidelines.

The "absolute minimum" tier was an H.I.V. test and a hematocrit, which measures the percentage of red cells in blood. "If your lab can't do those, you shouldn't be giving out antiretrovirals," Dr. Vareldzis said. Since AZT, a common antiretroviral, can cause anemia, "you could run the risk of killing somebody."

The next "basic" level includes blood tests that require equipment widely available in most district hospitals, even those in Africa. The equipment tests white blood cell counts and does simple liver tests.

The white cell count is a proxy for a CD4 test, which measures "helper T-cells" that set off immune responses. In the West, a CD4 count below 200 per cubic millimeter usually prods a doctor to prescribe antiretrovirals. But white cell counts move roughly up and down with CD4 levels, so white blood cell counts below 1,200, plus clinical signs of AIDS are enough, under the new guidelines, to justify starting the therapy.

"If someone has night sweats and weight loss and is definitely H.I.V. positive, you can't ethically deny them drugs just because you can't do a CD4 test," Dr. Vareldzis said.

Antiretrovirals can poison the liver, but simple liver tests plus eyes yellowed by jaundice or tender abdomens could be proxies for expensive toxicity tests in deciding whether to change drugs.

The health organization is also listing which drug cocktails it thinks should be tried first. Essentially, it suggests a mix of AZT, which is also called zidovudine, plus 3TC, which is also called lamivudine, plus a third drug like nevirapine or efavirenz or abacavir, depending on factors that include whether a patient is pregnant or hypersensitive to abacavir.

Making this an official recommendation "is a way to avoid all the waste and confusion and tendency to create resistance that exists in all the weird combinations that people came up with before," said Dr. Jonathan Quick, the health organization's director of essential medicines.

Listing the best drugs encourages makers of generic drugs to put three drugs in one pill, making it much easier for patients to take their medicine correctly, he added.

Three-in-one pills aren't made by the pharmaceutical giants because they would have to share their drug patents, which might violate antitrust laws.

The additions to the essential drugs list are abacavir, didanosine, efavirenz, indinavir, lamivudine, lopinavir, nelfinavir, ritonavir low-dose, saquinavir and stavudine. Ziduvodine and nevirapine were already on it for mother-child transmission, but can now be given to adults.

The introduction of triple-therapy in the United States in 1996 led to a 70 percent decline in AIDS deaths.

Dr. Harvey E. Bale Jr., director of the International Federation of Pharmaceutical Manufacturers Associations, which represents the major pharmaceutical companies in talks with the health organization, did not oppose putting patented drugs on the essential drugs list.

The industry, he said, has recognized the need to get AIDS drugs to the world's poor quickly and has lowered its prices until its AIDS drugs are competing with their generic counterparts. He cautioned that safe three-in-one pills were difficult to develop and must be thoroughly tested, and he complained that the health organization had rushed the guidelines through without its normal period for public comment.

On March 20, the organization released its first list of manufacturers of AIDS drugs whose factories it had inspected and ruled safe.

In a surprise to advocates for the poor who have called the organization overcautious and beholden to big drug companies and the United States, the list included generic makers from India and elsewhere.

"Countries now have the three bits of information they need - the names of the drugs, the quality assurance and the treatment guidelines," Ms. Perez said.