Inter Press Service - December 1, 2004
Yensi Rivero

"Given the doubts that have surfaced over the quality of these products, we have repeatedly asked the National Health Institute (INH) - a branch of the Ministry of Health - for the results of the bioequivalence tests conducted on them, but we have yet to receive a reply," Alberto Nieves of Citizens' Action Against AIDS (ACCSI) told IPS.

Generic drugs (which have the same active principles as patented brand-name medicines but are far less costly) produced by Ranbaxy and Cipla of India have been subject to scrutiny since June, when the WHO removed a number of them from its list of prequalified antiretroviral (ARV) products.

ARVs are substances that inhibit the replication of retroviruses like HIV, which causes AIDS.

The drugs were withdrawn due to possible flaws in bioequivalence testing, used to demonstrate that generic drugs have the same effect as the original patented brands.

Last month, Ranbaxy voluntarily pulled seven of its AIDS drugs off the WHO list, announcing that it would carry out new tests on their effectiveness.

A short time later, another Indian company, Hetero Drugs Limited, followed suit, withdrawing all six of its generic ARV drugs.

On Tuesday, however, the WHO announced that two of the products made by Cipla have been returned to the list of authorised drugs, after the company carried out new studies that proved them to be just as effective as their brand-name equivalents, according to a statement from the global health organisation.

The two products in question are Lamivudine 150mg tablets and Lamivudine 150mg plus Zidovudine 300mg tablets, both widely used in the developing world.

Shipments of these and other generic drugs were purchased in June by the Venezuelan state at far lower prices than those charged by the big pharmaceutical companies for patented medicines.

Opting for the generic version meant savings of 80 percent, or between 17 and 20 million dollars.

During the first month after they were acquired, over 4,000 patients took the drugs, with some reporting side effects like rashes, heartburn and gastritis.

These reactions raised alarm among organisations that defend the rights of people with HIV/AIDS. Although side effects are normal for all ARVs, the groups remain concerned.

"Since the INH has not responded to our request, we have now turned to the courts, because people infected with the virus need to know what kind of drugs they are taking," said Nieves.

A Caracas court has accepted the petition made by ACCSI and other organisations and called on the INH to publish the results of the bioequivalence tests carried out by Ranbaxy and Cipla, as well as those conducted by Heber Biotec, another generic drug manufacturer, based in Cuba.

The government institute has been asked to either provide the results or at least explain why it is refusing to do so.

INH president Jesus Querales told IPS, "These documents are under the safekeeping of the institute, and public access to them is restricted. The non-governmental organisations know that this information is confidential."

If the Venezuelan government were to make the documents public, they would be committing an illegal act, because there are international agreements involved that cannot be violated.

"The institute is in possession of the test results. The drugs met all of the requirements necessary for use in Venezuela," Querales stressed.

A joint statement released by the Venezuelan Ministry of Health and the WHO emphasised that the questions raised over the Indian laboratories did not mean that their products fail to meet with international standards for quality, but rather that bioequivalence had not been adequately determined during the most recent WHO inspection.

AIDS drugs developed and patented by the big drug companies of the North are far too costly for patients in the developing world.

As a result, the right to produce and acquire generic versions has been one of the hardest fought health care battles waged by governments of the South in recent years.

"The war on generic AIDS drugs responds to purely commercial interests. In the 1990s, because of the state of emergency, almost all of the patented brand-name drugs were administered directly to humans, with very little prior testing," noted Miguel Alfonso, a Venezuelan HIV/AIDS researcher.

"The patented brands have side effects, too. If there is a medicine that costs one dollar, and has both the same positive and negative effects as a commercial product that costs 100 dollars, then why not use the one-dollar one?" he asked.

Nevertheless, the fears raised by the WHO measure have led some patients to stop taking their medication, which could give rise to even more serious problems, like the development of resistance to the drugs.

In the meantime, the NGOs are still waiting for a response from the INH. If their request is not fulfilled, they will turn to the Supreme Court.

In 2000, the Supreme Court ordered the Venezuelan state to provide ARV therapy free of charge to the country's HIV/AIDS patients.

According to estimates, there could be between 70,000 and 100,000 people in Venezuela infected with the virus, out of a total population of 25 million, although less than 15,000 are registered with the public health system.

The acquisition of generic drugs through direct government-to-government transactions has been presented by the administration of left-leaning President Hugo Chávez as an example of efforts to promote South-South cooperation and trade.

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+ WHO (http://www.who.int/)

+ HEALTH: Goodbye to Cheap Indian AIDS Drugs? (http://www.ipsnews.net/interna.asp?idnews=26442)

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

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