Inter Press Service - July 19, 2004
Humberto Marquez

The Health Ministry "will buy equivalent medication from the Ranbaxy laboratory, also in India, on short orders, but with enough supplies for the rest of the year," Alberto Nieves, with Citizen Action Against Aids (ACCSI), told IPS.

Around twenty non-governmental organisations (NGOs) working on the HIV/AIDS front in Venezuela complained to the Hugo Ch vez administration and WHO after the alarm caused by the withdrawal of the CIPLA drugs Duovir and Lamivir, which Caracas had purchased and distributed among the patients receiving free treatment from the pubic health system, from the WHO's list of prequalified medicines.

There are an estimated 70,000 people living with HIV, the AIDS virus, in this country of 25 million, according to NGOs, although only 12,540 cases are listed with the Health Ministry, including around 300 children and adolescents.

Under a ruling by the Venezuelan Supreme Court, HIV/AIDS patients have had a right to free antiretroviral medication since 2000. The public health ministry earmarks some 30 million dollars a year to purchase supplies of 17 different drugs, said director of Populational Health Evelyn Escalona.

Six generic medicines are imported from India, two from Cuba and the rest carry the trademarks of transnational laboratories, said specialist Deisy Matos.

In June, the government reported successful negotiations for purchases of generic medicines from the CIPLA and Ranbaxy laboratories, which implied savings of between 17 and 20 million dollars a year, coupled with a price reduction agreement that Argentina, Bolivia, Chile, Colombia, Ecuador, Mexico, Paraguay, Peru and Venezuela arranged with transnational drug companies.

But a wrench was thrown into the works of this South-South cooperation initiative when WHO removed CIPLA's Lamivir (lamivudine, 150 mg tablets) and Duovir (tablets combining 300mg of zidovudine and 150mg of lamivudine) from its prequalification list in late May.

For more than a month "at least 4,970 people (40 percent of the Venezuelan patients) received these combinations," Nieves told IPS. Several organisations received reports from patients suffering the effects of ingesting a toxic drug, with symptoms including skin rashes, stomach acidity, gastritis and swelling.

Some of the symptoms could be due to physical and chemical causes, but they could also be a result of the anxiety caused by the drugs' removal from the WHO list, he said.

The Health Ministry and WHO responded to the NGOs with a joint declaration stating the suspended certification did not question the quality of the antiretroviral drugs but was based on the fact that the independent laboratory carrying out bioequivalency tests failed to provide the necessary documentation.

Cipla said it was contracting a new laboratory, and carrying out new bioequivalency tests.

"The important thing here is that the NGOs have operated as a social ombudsman and the relevant authorities have responded to and worked with us," stressed Nieves.

"We believe the measures taken by the government are adequate and help maintain calm, because patients are apprehensive about generic drugs from India and Cuba," he added.

Feliciano Reyna with Acci<=n Solidaria, another local NGO, said "tablets of Didanosine crumbled and became unusable barely three months after they were brought from Cuba." He claimed the scientific evidence of bioequivalency was weak for the Cuban generic drugs Lamivudine and Stavudine.

The Chavez administration runs cooperation programmes with Cuban health entities and services. The most visible aspect of the cooperation are the 10,000 Cuban doctors now working in slum neighbourhoods in Venezuela's large cities. The programme, called Barrio Adentro (Into the Neigbourhood), has brought primary health care to the poor and has given Chavez's popularity a major boost.

It is precisely the money saved in buying antiretroviral drugs from Cuba and India that the government has planned to use for AIDS prevention programmes.

In response to the criticism, Escalona said the drugs bought in Cuba, as well as those purchased from other countries, "have passed the bioequivalency tests and clinical trials of the Venezuelan Institute of Hygiene."

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+ ACCSI - in Spanish (http://www.internet.ve/accsi)

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