the HIVe

collecting HIV/AIDS info for my community

Archive for the ‘MCC’ Category

Bureaucratic red tape kills

Posted by Rouvanne van den Berg on May 15, 2007

It is a disgusting fact that bureaucratic red tape kills people; and never more so than in the case of getting life-saving drugs registered by the Medicines Control Council (M.C.C.); and by the big pharmaceutical companies that develop these drugs.

On the 22nd of February, the T.A.C. (Treatment Action Campaign) marched on the headquarters of Aspen Pharmacare, to petition them to start supplying Tenofovir (trade name Viread) – an antiretroviral that has less side-effects than d4T, and is also only taken once a day along with the combination of other drugs.

In short…

Tenofovir (Trade name Viread) is an anti-HIV drug approved by the FDA (In October of 2001) to be used in combination with other HIV fighting medications. Viread belongs to a new class of drugs called Nucleotide Reverse Transcriptase Inhibitors (NtRTI). These are related to Nucleoside Reverse Transcriptase Inhibitors (NRTI) like zidovudine (AZT, Retrovir). The body converts Viread into a chemical that prevent HIV from reproducing in uninfected cells, but it does not help cells that have already been infected with the virus. As people with HIV lose CD4 cells – one of the immune system’s main defenses – they become more likely to get infections and illnesses.

Just so that it is understood – this drug is used to boost the immune system, and not to cure the disease…

Currently available anti-HIV drugs like AZT need three separate chemical steps before they are active. Viread needs only two chemical reactions (phosphorylation) to occur before it can start working. Partly due to this unique chemical feature, Viread also carries a “negative charge”, allowing it to stay in the cells where it is active for a longer period. As a result, Viread only needs to be taken once a day.

Released in the USA in October 2001, the T.A.C. blames Aspen & Gilead Sciences, and the M.C.C., for delays that saw Tenofovir finally being registered in April 2007. Stephen Saad, CEO of Aspen Pharmacare responded to the T.A.C.’s petition by saying that they “… have worked hard to produce this product, and have spent over R20 million on its research and manufacturing. The drugs are at this moment in our warehouses. But we cannot legally distribute them or make them available without authorization from the M.C.C.” (The Informer).

There has to be a way that this registration process is shortened. Trials and testing are going to be a factor, but I do not think that this causes the delay. Bureaucracy is responsible for suffering, and in some cases, shortening peoples lives, and I don’t really care who blames who – HIV/AIDS is an international problem that needs immediate action for everyone!


Posted in antiretroviral, Informer, MCC, medicine, TAC | Leave a Comment »