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WHO pulls three more AIDS drugs from list
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     In a major blow to efforts to get lifesaving AIDS treatment to millions of people in the world抯 poorest countries, the World Health Organization has withdrawn three more generic drugs from its original list of seven approved AIDS medicines.

    The move came after laboratory tests failed to prove these three drugs have the same chemical make up (or bioequivalence), as their patented equivalents. Two other generic AIDS drugs were removed from the list in June for the same reason.

    The lack of bioequivalence means that these generic copies may not be as effective as the original patented equivalents.

    WHO requires proof of bioequivalence for products that it recommends for serious conditions such as AIDS, malaria, and tuberculosis.

    Officials at WHO said that more stringent checks may now have to be introduced before such products are recommended in future.

    Peter Graaff from WHO抯 AIDS medicines and diagnostics service, said that WHO was advising countries to suspend use of the drugs that had been removed from the "approved" list, but if they have no alternative, to weigh up continued use against the risks of interrupting treatment.

    Mr Graaff noted that the drugs that had been removed from the list fulfilled all other requirements on quality, specifications for active ingredients, impurity profile, and manufacturing.

    He warned that despite their suspension pending further laboratory tests, switching to other products that have not been registered in a country with a strict regulatory system could be more risky.

    "Although we are not 100% sure yet whether these drugs are bioequivalent, at least we know they are of good quality and safe," Mr Graaff said.

    Some generic AIDS drugs on the market have not passed WHO compliance tests, but WHO officials say they cannot publish a list of them for confidentiality reasons.

    Procurement of cheap copies of patented drugs is central to global efforts to scale up treatment for millions of AIDS patients in developing countries who cannot afford antiretroviral drugs, which stabilise but cannot cure their chronic disease.

    The removal of five of seven WHO recommended AIDS drugs is set to hamper these efforts and fuel highly vocal criticism by drug companies and their advocates that generic copies of their patented products are substandard.

    Andre Zyl, a WHO pharmaceuticals expert, said that non-compliance in some aspect of generics pharmaceuticals production was not unique to generics, noting that problems have emerged with patented AIDS drugs in the past after they were licensed.

    The three latest drugs to be removed from WHO抯 approved list are products of the Indian generics company Ranbaxy.

    One is a "two in one" pill combining 150 mg lamivudine and 300 mg zidovudine. The other two are three in one pills, one combining 150 mg lamivudine, 30 mg stavudine, and 200 mg nevirapine, and the other combining 150 mg lamivudine, 40 mg stavudine, and 200 mg nevirapine.

    The two AIDS drugs remaining on WHO抯 approved list are a two in one pill combining zidovudine and lamivudine and a three in one pill combining lamivudine, stavudine, and nevirapine. The three in one pill has been checked and found to fulfil bioequivalence. The two in one pill is undergoing checks but it has not been suspended.