In the fight against AIDS, there is an increasing variety of drugs available to help relieve the symptoms for unlucky sufferers. Properly administered and manufactured, anti-retroviral (ARVs) drugs can help the victims of AIDS live longer and more useful lives. However, the widespread use in Africa of poor quality generic copies of these drugs is threatening to undermine their clinical effectiveness, bringing with them the possibility of new, drug-resistant strains of HIV.
ARVs are no silver bullet. They do not cure AIDS. What they do, however, is to allow sufferers to live more normal lives. Putting a patient on ARVs is a long-term commitment, since the course of drugs must continue for life. The World Health Organisation (WHO) is responsible for recommending which particular ARVs are suitable for use in each part of the world. Currently there are about 89 products on the WHO pre-qualified list, 54 of which are anti-retrovirals for the treatment of HIV/AIDS.
The WHO is not a regulatory authority, and neither does it have the facilities nor experts to test and certify the quality of generic ARVs. Egged on by NGOs such as Medecins Sans Frontiers and the Clinton Foundation, the WHO has bet its shirt on recommending mass treatment programmes based on ARVs that have been copied from drugs patented by pharmaceutical companies. The WHO figures this is the cheapest way to get drugs to the millions who need them. Unfortunately, this short-sightedness has put the safety of several thousands of patients at risk.
Late last year the Indian generics manufacturer, Ranbaxy, withdrew seven of its medicines because it could not guarantee they were potent enough for patients. This followed hot on the heels of the WHO’s decision to de-list from its list of pre-qualified drugs two other antiretroviral medicines manufactured by Cipla and six generic ARV medicines manufact! ured by Hetero Drugs Limited of India.
This delisting proved to be an embarrassment for the WHO and the NGOs who had been arguing that generics manufacturers in India, South Africa and Thailand could safely make sophisticated multi-dose combinations of AIDS drugs by mixing patent medicines.
In reality, it soon emerged that these manufacturers were turning out copies that were not exact replicas of the patented drugs. This problem was further compounded because of gross discrepancies between the data supplied by manufacturers for drug registration purposes and non-compliance with international guidelines on Good Clinical Practices and Good Laboratory Practices.
One has to ask why these drugs got the WHO’s seal of approval in the first place. None of these drugs would have been deemed satisfactory to either the European or U.S. health authorities and were never submitted to them for approval. But these poor- quality copies were still approved for use in Nigeria.
In December last year, Nsikak Ekpe, President of AIDS Alliance in Nigeria, said he was worried about irregularities in the procedure for the approval of ARVs. He also said that some of his members were being given ARVs that had been de-listed by the WHO. Meanwhile, the National Food and Drug Administration Control (NAFDAC) still insisted that those de-listed ARVs were safe.
So where does this leave Nigerians who are already suffering from AIDS? Certainly, ramping up the use of cheap generic ARVs could increase the number of people receiving treatment. However, mounting evidence shows this strategy to be ill-conceived and dangerous.
Firstly, laboratory findings have not confirmed that most of these generic ARVs dissolve properly into the bloodstream to lower virus levels. Secondly, and more importantly, these drugs are a significant contributor to the development of drug-resistant strains of HIV/AIDS. Thirdly, generic copies of! patented AIDS drugs can deliver a weak dose to patients which allows the virus to adapt and then mutate. This could quickly render the currently available generic ARVs useless, and put the WHO’s AIDS strategy back to square one.
Despite all this, African countries have continued to get second grade medicines. These same, unsafe drugs would never be offered to patients in the west without the officials of WHO going to jail. Why should we in Africa put up with this?
Some African countries are awake to the dangers of these poor quality generics. Uganda has suspended the importation of ARVs from the Indian manufacturer Ranbaxy, and has further advised patients to discontinue their usage.
In spite of the glaring evidence, this has not stopped the campaigning of AIDS activists who continue to focus myopically on the price of generic ARVs. But if they continue to insist on having poor second-grade drugs on account of price while ignoring quality! , safety and efficacy, the plight of those already infected will be made far worse. AIDS activists attitude to treating victims with cheap but poor quality drugs is tantamount to gradual and slow killing.
Several progressive African countries have long ago realized that generic ARVs are not the only answer to the AIDS problem. Uganda and Senegal have managed to bring their infection rates under control through comprehensive education and awareness programmes. Their governments have also collaborated with the private sector to build clinics from where safe, quality and tested ARVs can be distributed. These are the things all African governments should be doing.
It is reprehensible to make available to Africans generic pre-qualify drugs of which the
WHO itself has issued this disclaimer: "Inclusion in the list does not constitute an endorsement, or warranty of the fitness, of any product for a particular purpose, including in regard of its safety and efficacy in the treatment of HIV/AIDS."
HIV victims in Africa deserve better than to have untested and poor quality ARVs foisted on them by the WHO and western NGOs. Africans deserve high quality medicines which would pass muster in the west, or risk rising drug-resistance and increasing illness. The WHO’s current strategy of fighting AIDS is nothing but a sticking plaster on a massive wound, and it is fast becoming unstuck.
• Ayodele is coordinator of the Institute of Public Policy Analysis based in Lagos