The New York Times - July 8, 2004
Lawrence K. Altman

At least 27 Asian companies are manufacturing anti-H.I.V. drugs that are becoming increasingly available in Asia and elsewhere, the organization said. Yet anti-H.I.V. drugs from only three companies meet the World Health Organization's quality standards; those from the 24 other companies have not been reviewed by the organization or have not met its standards.

Most Asian countries have far too few doctors and health workers trained to properly prescribe the drugs and monitor their use for the continent's estimated 7.4 million infected people, the organization said.

The warning was in a report by Treat Asia, a network of clinics, hospitals and research institutions sponsored by the highly regarded American Foundation for AIDS Research in Manhattan.

A copy of the report was made available to The New York Times. The report is expected to be discussed in greater detail at the 15th International AIDS Conference, which begins here on Sunday.

Dr. Joep Lange, a Dutch scientist who is the president of the International AIDS Society and who read the report last week, said he was surprised by the findings.

"I didn't realize there were so many companies" involved and that "the number of Asian doctors trained to treat AIDS is so frighteningly low," Dr. Lange said in an interview.

"We need to scale up training efforts quickly and develop a better mechanism for quality control of drugs," he said.

Advocates for AIDS patients and health officials have called for wider availability of lower cost generic anti-H.I.V. drugs to treat the world's 38 million infected people. Many Asian manufacturers are rushing to introduce generic drugs in advance of regulations that could affect the sale of those drugs, the report said.

But anti-H.I.V. drugs can vary in purity, potency and the way chemicals are combined. Without adequate quality control and careful supervision of care, the authorities say, the medications may be ineffective or create imbalances that pave the way for the virus to mutate, developing resistance. Two of the 27 manufacturers are in Thailand, where an estimated 84,000 people are not receiving antiretroviral treatment. But the Thai government has exported $3 million of H.I.V. drugs, the report said. Dr. Lange, the International AIDS Society president, said the percentage of infected Thai people receiving antiretroviral treatment was "strikingly low."

Thailand has one of Asia's most sophisticated health care systems, but only 100 doctors trained to treat AIDS, or about one doctor for every 6,700 H.I.V.-infected patients, the report said. Although Thailand has been a leader in preventing H.I.V., health officials fear that complacency is leading to a new wave of the epidemic.

"Our point is if there is proliferation of the generic drugs, as many are calling for, where is the infrastructure to deliver them?" said Kevin Robert Frost, a public health worker for Treat Asia in Bangkok and a co-author of the report.

"In Asia, the availability of drugs is far outstripping the capacity to deliver them," Mr. Frost said in an interview. Also, he said, "many questions linger about the relative safety and consistency of these drugs."

Treat Asia urged the creation of a regional database of generic manufacturers to help determine which drugs are available in each country.

China has fewer than 200 doctors trained to treat the estimated 840,000 people infected with H.I.V. Last year, China offered free treatment for 5,000 patients. But health workers handed patients pills without counseling. Within weeks, 20 percent to 40 percent of the patients stopped taking the drugs, Mr. Frost said. The combination of drugs used by the Chinese apparently led to a high rate of unwanted side effects, he said.

China "desperately needs to introduce a new combination of antiretroviral drugs," Mr. Frost said.

Elsewhere, "prescriptions from unqualified health care workers have left many people with little or no instruction on the safe and proper use of antiretroviral drugs" the report said, and "the consequences of widespread self-medication can be catastrophic."

"Wealthy Cambodians who know they are H.I.V. positive frequently self-medicate with antiretrovirals purchased over the counter," the report said.

Mr. Frost said that he began the study in the spring after seeing a spurt in the availability of generic drugs that had escaped the attention of most AIDS authorities and health officials.

Mr. Frost, a former advocate for people with AIDS who worked on AIDS research at New York University, said his team based its report on consultations with top health care officials in 15 Asian countries and interviews with dozens of officials in government, pharmaceutical companies and AIDS organizations. He described the report as the first systematic study of its kind.

Treat Asia's warning follows by a day a report from the United Nations that said that the incidence of H.I.V. in Asia in 2003 rose to the point where the continent now accounted for one in four of the world's new H.I.V. infections.

The Treat Asia report, which will be published on the organization's Web site (www.treatasia.org) beginning on Sunday, also follows a decision in June by the World Health Organization to drop two generic H.I.V. drugs from its list of approved treatments.

How devastating the epidemic of H.I.V. in Asia could become is a subject of debate. A report by the National Intelligence Council, a government, academic and private sector group, issued in 2002 said Asia's epidemic could grow to affect as many as 40 million people by 2010. Others have been less pessimistic in their predictions.

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