Tuesday 12 November 2013

Nigeria: The issue of sub-standard ARV drugs is a critical emergency

The drugs are not working
I was contacted this morning about a grave and critical issue where the person believed their life was imperilled by the use of therapeutic drugs meant to manage HIV/AIDS.
My first reaction was one of shock before I collected my thoughts to determine where I could get more information about critical pharmaceuticals in Nigeria, the management of their standards, the organisations that cater for HIV/AIDS sufferers and the supply chain that governs the acquisition and distribution of anti-retro viral drugs (ARVs).
Sub-anything is serious business
It is important that we differentiate between fake drugs which is not the issue and sub-standard drugs. Fake drugs would be the passing off of different chemical concoctions as the real medication, whilst sub-standard drugs will pertain to potency, quality, shelf-life, efficacy and utility of the medication.
These elements raise serious issues where sub-standard or possibly sub-strength drugs might well not manage the virus in the blood leading to a rapid deterioration of health presenting AIDS.
The other aspect of this is where sub-strength drugs might lead to drug-resistance if the commensurate dosage is not adjusted for potency needing the use of second-line and more expensive non-generic drugs. The environment in Nigeria will probably leave many at greater risk if their normal medications are not working and the bleeding-edge medications we have access to in the West are out of reach.
No excuses are satisfactory
The worst situation to be in is not so much to have no access to ARVs, but to be given ARVs that are effectively placebo drugs, and that is both unacceptable and a health emergency.
Now, there are organisations in Nigeria that may want to easily explain this away and link it with some social response to the provenance and pedigree of the drugs.
The “Made in Nigeria” label may not lend itself to sophisticated goods, but I doubt those on the receiving end of these life-saving treatments have carried their everyday hedonism to the level of refusing to use their drugs because they do not have designer labels.
A known problem
Searching for “Sub-standard ARVs in Nigeria” on Google, I found a YouTube video highlighting that this is an emergency and Treatment Action Movement (TAM), a coalition of HIV treatment activists across Nigeria, in collaboration with the AIDS Healthcare Foundation (AHF-Nigeria) gave a press release on the matter. [AIDS Healthcare Foundation]
The AIDS Healthcare Foundation (AHF) will probably put a few backs up with their advocacy and activism. They are more than a necessary organisation in the fight against the scourge of HIV/AIDS, the inertia of the government and other vested interests in the face of unacceptable statistics and paucity of programmes to get more people tested and treated, especially in Nigeria. [AHF - Nigeria]
Old but useful drugs
The TAM-AHF press release mentions a company but more importantly, the drugs in use are the AZT/3TC/NVP and the TDF/3TC combinations.
The WHO recommends the use the AZT/3TC/NVP combination for the treatment of Antiretroviral therapy (ART), ART-eligible pregnant women in developing countries, which also means that we cannot afford substandard drugs or episodes of recidivous decline to drug apathy for whatever reasons and the reasons appear to be many.
Besides treating HIV/AIDS patients, it is critical we prevent the transmission of the virus in-vivo to the foetus during gestation.
Really poor standard
The press release suggests the drugs “are brittle, break easily and dissolve in one's mouth before swallowing, and furthermore the package presentation is substandard, with poor labelling that resembles the work of professional counterfeit drugs peddlers.” [AIDS Healthcare Foundation]
This is just unacceptable either from the perspective of quality and quality controls to giving the HIV/AIDS patients the confidence to ingest their medication and have the medication be efficacious.
Whether binding agents or preservation agents are poor used or corners are being cut for profiteering, I expect the people who are the public faces of HIV/AIDS advocacy to be at the forefront of pushing for improved standards rather than present excuses for this seeming atrocity.
One voice for many
The person who contacted me had both the opportunity and the options; there are millions who do not have any of the opportunities and the options, that person has but they must be heard too.
It is a cause of our wider humanity beyond Nigeria and its local problems or politics to ensure that either these people have a voice. The Federal Ministry and other agencies must arrest an untenable situation by demanding better standards of drug-formulary or we have to embarrass them for unconscionably allowing avoidable deaths through the dereliction of responsibility, their diminished oversight functions and their lack of purpose towards managing the HIV/AIDS epidemic.
Once again, the issue is about sub-standard drugs and not fake drugs, it is an emergency; shoddy quality controls just would not cut it, and the raising of standards must be of the utmost urgency.
We obviously need to research this issue more to appreciate the extent to which people might be put at risk, but one person on sub-standard ARVs drugs is one too many presaging avoidable and preventable tragedy.
Thank you.

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