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May 26, 2017

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AIDS treatment: quality over quantity

Today is annual World AIDS Day, when health activists lobby their governments to spend ever larger sums and to achieve "universal" anti-retroviral treatment by 2010. This ambitious target will only be met if political considerations continue to trump science and to endanger HIV-AIDS patients.

The World Health Organization (WHO) is the brains behind this "universal" supply of ARVs for 9.7 million HIV-AIDS patients by 2010. It is based on the massive use of copy drugs from India, bringing the numbers of patients in poor countries on treatment up from virtually none in the early 2000s to 3.5 million today.

While activists have applauded the speed of this "scale-up," it creates dangers. Many of the copies recommended by WHO are untested so patients cannot be certain that they act on the body in exactly the same way as the original (called bioequivalence). If the level of active ingredient is not absolutely correct, it can accelerate drug resistance and the mutation of the AIDS virus. Under Indian law, drugs manufactured for export do not have to prove bioequivalence with the patented original.

This is well-known to the authorities. The WHO issued a Disclaimer, stating that its recommendation of a drug does not "constitute an endorsement or warranty of the fitness, by WHO of any product for a particular purpose, including in regard of its safety and/or efficacy in treating HIV/AIDS." But in real life the WHO's list is followed by many poor countries that cannot carry out drug evaluation themselves.

In 2004, the WHO had to cease recommending 18 of the Indian ARVs on its list because of quality fears, although some were later reinstated.

The Global Fund to Fight AIDS, Tuberculosis and Malaria, the main funding body for AIDS treatment, is equally lax about drug quality. Its "Option C" procurement guideline authorizes drugs "not reviewed by a regulatory authority," justifying this by lower prices and "political considerations" such as bolstering the fledgling African pharmaceutical industry.

The Clinton Foundation serves as a procurement agency for the Global Fund and for UNITAID, a U.N. scheme which raises monies for AIDS, TB and malaria via an airline tax. The Foundation claims its tests on the drugs it buys have not revealed any safety problems.

But the Foundation is procuring a copy of the widely-used ARV Liponavir+Ritonavir (LPV/r) from an Indian firm. It has been submitted to the FDA for certification as a "true generic" but no approval has been forthcoming although the original is already approved.

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