Nigeria: Presumed Substandard Tyonex HIV/AIDS ARV Drugs Removed From Circulation

Click to large

I received this picture on Twitter earlier.

I am pleased to read that the concerns raised about SubStandard HIV/AIDS ARV drugs have registered with NAFDAC and they have taken appropriate action to suspend with immediate effect all the ARVs manufactured by Tyonex Nigeria Limited.

I first wrote about this in November http://goo.gl/fYINqS and then when I got hold of the said drugs in December I posted another blog and wrote to NAFDAC about the issue http://goo.gl/kQOh8t

Obviously, NGOs have been clamouring about this for months and to have a letter acting on the issue is a very successful outcome for all those whose vulnerability has somewhat been abused by failings in the drug administration system.

There is much work to be done to build on this success, it is however wonderful news.

Blog - Nigeria: These Sub-Standard ARV Drugs are Completely Unacceptable

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

Nigeria: These Sub-Standard ARV Drugs are Completely Unacceptable

Until now

Just over a month ago, I wrote about the issue of sub-standard anti-retro viral drugs (ARVs) in Nigeria, and when some of my friends contacted people who were supposed to be in the know about the management and distribution of ARVs in Nigeria, they appeared to pooh-pooh the idea.

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

The message coming back was that the complainers were not interested in using drugs manufactured in Nigeria, that they wanted foreign-sourced drugs.

Handling the ARV drugs

Well, this afternoon, I handled with my own hands the drugs, a bottle from India and Nigeria of the same formulary of ARVs (Zidovudine [AZT] 300mg, Nevirapine 200mg, Lamivudine [3TC] 150mg), but that is where the similarity ends.

It is important that we clarify that the drugs are not fake, they are sub-standard, and I would illustrate what I mean with pictures to follow.

The Indian manufactured bottle is on the left, the Nigerian manufactured bottle is on the right, and the first thing that you see is the poor quality of the labelling.

By comparison the shelf-life of the drugs is 35 months for the Indian version and 23 months for the Nigerian version – A first indication of a difference in quality or standards.

The question of Storage

The problem seems to come down to information on this part of the bottle label. The Indian version is to be stored below 30°C and protected from light and moisture, the Nigerian version should be stored in a dry place below 25°C and protected from sunlight.

A double-take to the World Bank website for the average temperature and rainfall in Nigeria  and in India for the 110 years to 2009 suggests the average temperature in Nigeria only dips below 25°C in December and January, and it has a higher average range than that of India. [World Bank Group][World Bank Group]

Besides this, whilst Nigeria does not have as much rain as the monsoons of India, the rainfall is spread across more months suggesting the climate in Nigeria is broadly humid resulting in more months of precipitation.

It goes without saying from this basic observation that the instructions on the bottle of the Nigerian manufacture ARVs must at least be the same as the ones for India – Store at below 30°C, in dry place, protected from light and moisture.

Between English and French

It is also interesting to note the difference been the English and the French instructions on the Nigerian bottle. Apart from the typographical errors where the obvious one is physician spelt as pyhsician, why Anglophones should be concerned about sunlight and the Francophones are more affected by humidity, escapes me.

A French-speaking observer of this said, “It is full of typos, and badly translated from English.” In other words, this is patently shoddy work and that is just the labels on bottles on life-saving medication.

With the permission, my French-speaking friend, reviewed the French part of the label and his comments appear below:

Chaque ma' dicament contient:
[...]

La prescription des pyhsician seulement.
Gader tout medicament hors de la portes des enfants.
Mettax su frais bas de 25°C. Protegez de l'humidite.

It is just about understandable.
It should be:
- médicament not ma'dicament
- physician, wrongly spelt is an Anglicism, in French it should read: Seulement sur prescription médicale
- gader (keep) is misspelled = garder
- la portée (reach) misspelled
- Mettax misspelled = mettre (keep/store) but should be "conserver"
- su misspelled = au (at)
- bas: poor translation of "bellow" = en-dessous

All the accents are missing and overall it say on prescription only, keep away from children store below 25°C, protect from humidity.

It does not make any reference to sunlight.

Why Tyonex could not get a French speaker in Nigeria to properly translate the English portion of the label to French escapes me. I am sure Google Translate would have done a better job. It is unprofessional, shoddy and really dampening in confidence.

Inside the bottle

Opening the bottles, the quality becomes evident, the Indian version has a desiccant, the Nigerian version does not, the tablets or caplets as the label indicates are in a cling film bag all coated with the white dusty powder of the pills.

The Indian version remains intact to the touch whilst the Nigerian version leaves a chalky residue on the fingers when touched and when held firmly between the thumb and a finger, it disintegrates as seen below.

I note that in the blog I wrote last month, this is what the AIDS Healthcare Foundation said – ‘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]’

The standards are poor

It goes without saying that poor manufacturing standards without consideration for the socio-economic and climate conditions in which the drugs would be used can inform the rapid deterioration of the medications leading to sub-par efficaciousness of the medicines, the consequences which can be dire and life-threatening to patients who need these drugs to survive.

Even if the drugs were to be kept in a fridge, the power situation in Nigeria precludes that, it only means that standards should be significantly raised to improve the quality of these drugs, and one cannot say what other drugs are poorly packaged and distributed as these.

This ARV is Manufactured by, Divine Essential Formulations and Distributed by Tyonex Nigeria Limited at the same address in Igando, Lagos State, Nigeria. [Other Tyonex Anti-Retro Viral Drugs]

What is NAFDAC doing?

It is more shocking to read from the label that these copies of the ARV drugs are manufactured under licence from the Federal Ministry of Health in collaboration with Millennium Development Goals (MDGs) under the auspices of the MDGs 2009 Conditional Grant Scheme. [UNDP NIG (PDF)]

The label also has a NAFDAC Reg. No: A4-6854, which begs the question of what standards of inspection and quality that organisation imposes on drug manufacturing companies to ensure the general public are not put at risk.

There is every reason to believe that the manufacture of short shelf-life, poorly labelled, badly packaged and low integrity ARVs means corners have been cut in the system, somewhere between the bureaucracy and the businessmen who are probably paid to do a better job than this.

Act now!

It is the duty of everyone to ensure that the chain from sourcing of formulation through dispensing to the patient ingesting the drugs is maintained to the highest standard of manufacture and integrity for us to be confident that drugs meant to save lives are not placebo effect dummies with no efficacious value.

I also hope everyone involved including activists ensure that they are compromised and bought off by the system where the lives of ordinary people are impacted.

When I was contacted about this issue last month, the person had suffered a precipitous fall in their CD4 count to 25% of what it was 6 months before. That is just unacceptable, and it indicates a sense of urgency and an emergency that needs to be addressed with immediate alacrity.

There were no other indications in the bloods that could account for that result apart from the Nigerian manufactured ARVs, and it would appear more of the Indian manufactured ARVs are now being distributed in Nigeria.

Additional Information:

NGOs Condemn the Supply of Sub-standard ARVs at Treatment Centres in Nigeria: http://youtu.be/YO4r1sZffrM

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.

Opinion: Tackling the Culture of Blacks Handling Disease

The taboos we must break

I found myself nodding in agreement to literally every line I read in this article published in The Body magazine – The Complete HIV/AIDS Resource – titled Breaking Through: HIV and African Americans.

If we removed HIV and replaced it with cancer, diabetes, hypertension, or misfortune, we would have subconsciously listed a sliding scale in terms in growing confidence to talk about how certain issues affect us.

Someone dying of the complications of HIV might only be able to accept that they are dying of cancer, the visible signs and sometimes along with diabetes means, we never attempt to ask more probing questions.

Our false stories

As I read the article, the writer informed that he had lost three relations, presumably African American to AIDS; two women, including his aunt and a man who insisted he was a heroin user when it was quite possible he was gay.

We have never been able to approach the reality of our diseases for the so many factors raised in that article. It is not just an African American thing; it is particularly African and probably broadly affects all non-Western cultures.

When I write blogs like this, I am wont to excerpting generous portions of the source material to make my points. However, I have decided we need to get the courage to begin to face the many issues that plague our communities as we suffer in silence, perpetuate the stigma and look at disease as the otherness that will never approach our steads.

We shock to numbness

We cannot deny that HIV/AIDS and cancer cuts a swathe through our communities like a wild forest fire that we treat as if it is insignificant, as our silence becomes a coping mechanism of convenience.

This means we fail to access health options and healthcare early enough for radical and timely intervention until it becomes an emergency exceeding effective medical treatment leaving us with just one option of palliative end-of-life care.

The story then becomes one of hospital visits, close family in shock at the apparently sudden deterioration in health of their relation as life slowly ebbs away no one the wiser about the truth until a nurse pulls one of the most affected relatives aside to say exactly what the diagnosis was. AIDS? Cancer? Usually not enemies scheming in the backyard, held at bay with Psalm 35.

There and then, the world collapses around every loved one and the questions start to flood the mind with prefixed inquisitive phrases of how long, how bad, how did, what can, how much – we have experienced this many times and yet we willingly hop on the vicious cycle of the culture of blacks handling disease badly.

The signs we ignore

We ignore the warning signs in the cause of the worry about the loss of our livelihood and the economic distress that accompanies a disease. Then visit our temples hoping and wishing for miracles with mountain-moving faith that had moves nothing more than the air that comes out of our mouths in fervent prayer, because we are in the mortal grip of fear; we rapidly approach an avoidable expiry date.

We listen to stories and conspiracies, we search for Shamanist cures in grottos that have defied the onslaught of civilisation and logic, imbibing awful concoctions too rotten for a recipe list and yet the temporary relief presages a catastrophic relapse before it is passed off in an obituary as a brief illness or a sudden death.

No fairy tale

These are the facts, Fela Anikulapo-Kuti, the “Nigerian multi-instrumentalist musician and composer, pioneer of Afrobeat music, human rights activist, and political maverick” died of Karposi’s sarcoma, and it is a form of skin cancer usually brought on by AIDS.

His brother, a prominent AIDS activist and former minister of Health could only talk about AIDS affecting his family after the man had died. Nelson Mandela’s son also died of AIDS, but we only learnt of that after the fact.

As a cancer survivor, I know how much I have revealed about my condition and the secrets that I still keep for the fears, the shame, the stigma and many other attendant issues that dog our cultural outlook to disease.

Yet, as the article states, and this I will excerpt, “Magic Johnson has not been cured by some medicine being kept from us.”

Ignoring our possibility

We can expect better medical outcomes if we talk, if we act or react immediately and seek professional advice when things are changing in our bodies that we cannot account for in our daily routine.

Karposi’s sarcoma as a result of HIV/AIDS complications was already treatable in the 1990s, and anti-retroviral (ARV) drugs manage HIV to the extent that people living with HIV can live very productive lives.

We cannot ignore our way round reality, nor can we bargain away disease with the false comfort of vows and the sudden laying on of hands; we need to accept first by understanding what we have* and that will inform the kinds of interventions that medicine or therapy can help us with, in a timely fashion.

[*This includes, HIV/AIDS, cancer, diabetes, hypertension, depression, mental illness, misfortune – tag anything you want to the list.]

Medicine is not evil and churches are not hospitals, but the beginning of dealing with the problem that plagues our community with the poison of silence is to read an article in a HIV/AIDS magazine about respected black women in the family dying of AIDS in today's America.

Finally, go for that test, it is about your life and keeping it.

Click on the link and read - The Body - Breaking Through: HIV and African Americans

Editorial: Twelfth of May 2011

Concerning another monkey vaccine

Two news stories appear to coincide with managing the scourge of HIV/AIDS, on the one hand is the study of eradicating the primate variant of HIV known as the Simian Immunodeficiency Virus (SIV) in rhesus macaques making use of a genetically modified version of the rhesus cytomegalovirus (CMV).

The good news here is that this vaccine appears to strengthen the immune system to the point of controlling SIV and eventually reducing its progressive infective rate until the disease is abated.

However, there are many concerns with this study from the controversial view that patient zero contracted HIV from a chimpanzee to the concerns of introducing a strain of human CMV as part of a treatment regime.

Africans may not benefit

CMV belongs to the herpes family of viruses that is usually benign or dormant but can break out as chicken-pox, shingles, fever blisters (herpes I) or genital herpes (herpes II) amongst others, it is more prevalent in sub-Saharan Africa than anywhere else making that line of research rather risky and ethically questionable in terms of safety and assurances for effectiveness.

This study might well be of greater value to those outside sub-Saharan Africa but after the failures of a number of vaccine trials, many of which were aborted too, it is important to remain vigilant that all checks, procedures and monitoring are in place so as not to raise false hopes at first and then cajole subjects into trials that might be of greater detriment to their already weak health status.

Helping sero-discodant couples thrive

Accepting the fact of the prevalence of HIV/AIDS has been hard enough for some societies and beyond that the measures needed to prevent infection are fraught with cultural, religious, political, social and economic issues.

UNAIDS have released a study that heralds the reduction of infection between partners where one is HIV infected or in the jargon, sero-discordant couples. The study began with about 1,750 couples from 8 countries in Asia, Africa and South America.

Entry into the study required the infected party have a CD4 count of between 350 & 550 which represents a level at which the WHO does not require the patient to have commenced Anti-RetroViral (ARV) treatment.

Between news and scientific fact

One arm of the study was immediately entered into ARV treatment on commencement of the study and the other arm only commence treatment after two consecutive tests measured a CD4 count regression to between 200 & 250 or had developed an AIDS-defining illness.

The results show a reduction in transmission of HIV infection in 96% of the cases as reported by UNAIDS but the news story does not appear to comment on the significance of viral loads which is the amount of virus in the blood that could determine how infectious a person can be.

It is however known that ARV does reduce the viral load significantly to somewhat undetectable levels it does not however mean the complete absence of contagion.

Subtle observations with this study

The study that took in couples from the United States was aborted and though it was supposed to run for 78 months seems to have ended 3-4 years early because of the positive results though one should be concerned about the fact that low viral loads and higher CD4 counts for the time of that study does not confer immunity by any stretch of the imagination.

The lack of Western subjects is also instructive because medication in the study did not include multi-class combination drugs like Atripla though combinations of other discrete drugs would have been effective all the same.

At the same time, it is possible that Eastern Europe might have benefitted from this study though on balance the cases of heterosexual HIV infection would have been more prevalent in the areas that had the study.

HIV is more than a medical condition

It is important that the kind of complacency that appears to attend to HIV infection in the West because of more effective treatments does not cascade to these other study areas that included India, Brazil, Thailand, Malawi, Zimbabwe and South Africa, the absence of Nigeria from that study group should be investigated too.

On the whole, the progress in trying to control, manage or cure HIV is welcome but the news stories appear to herald situations which on closer scrutiny of the facts belies less of the optimism being communicated.

Most importantly, there are significant anthropological consequences of these studies between countries, cultures, traditions and laws coming north of the equator in Africa would have given this study much more empirical import just as allowing it to include the West, China, Russia and Eastern Europe. HIV in different societies is a lot more than a medical condition even in the broadest terms.

Acknowledgements

The following sources form the basis of this editorial; the news about the CMV vaccine against SIV was published by the BBC then related to drug regimes reducing HIV transmission as published by UNAIDS but 6 months earlier, the BBC had run a similar story.

The HIV Prevention Trials Network (HPTN) Study is fully documented at the HPTN 052 website. Meanwhile the list of available drugs for the treatment of HIV as at February 2011 is hosted at the AIDSMeds website. Regarding CMV the New York Department of Health offers some information about the Cytomegalovirus.

That Thabo Mbeki Collective

Unable to minister to health

The news of the sacking of the South African Deputy Health Minister Nozizwe Madlala-Routledge with immediate effect last week by President Thabo Mbeki was received with alarm and sadness, but the reasons for her sacking are quite instructive and interesting.

Apparently, the minister had gone to an AIDS conference in Spain with her consultant son without the express permission of the President and he was no more going to countenance a situation where she exhibited the “inability to work as part of a collective” in cabinet.

One does not have to introduce Dr. Beetroot, the Health Minister Dr. Manto Tshabalala-Msimang whose inability to understand the demographic crisis of the HIV/AIDS pandemic in her country where 25% are purported to have succumbed to the disease is expressed in her recommending herbal remedies like garlic, beetroot and the African potato for therapeutic management of HIV/AIDS.

Accumulated ignorance of health

However, we should not forget that President Mbeki still has problems with the accepted body of knowledge about HIV/AIDS and the science that underpins most of that knowledge – indeed there is an economy dimension to how that disease can be managed, but those who are infected and affected need treatment now.

It took a global outcry as well as derisive appraisals of South African health policy before things started to move in the direction of the proper management of the disease with drug therapies and other initiatives, many of which were spearheaded by the Deputy Health Minister.

Her inability to work as part of that obdurate collective is commendable, because that collective once had a chairman of the South African National AIDS Council who became the Vice-President of South Africa under Thabo Mbeki say that he had a shower to wash himself clean after knowing having sex with an infected partner.

Mountain climbing a mole hill

Such crass ignorance beggars belief as there would now be no serious driver for these initiatives having sacked a minister for what would have been an error of judgement when other ministers thrive in the cabinet by long-standing affiliation to the president rather than competence, probity and worthwhile activity.

Mrs. Nozizwe Madlala-Routledge has obviously refused to be subsumed into the group think that assumes all is well when nothing is. She supported a damning report about conditions in the maternity wards of Frere Hospital which both her boss and the president desperately tried to debunk.

Detached, oblivious and complacent

However, what makes this even the more instructive is the way Thabo Mbeki’s friendship with Robert Mugabe, along with his complacency and the condoning of the nonsense going on in Zimbabwe is allowing the situation to deteriorate into complete anarchy. There is nothing on this earth that can support Robert Mugabe continuing to hold sway over his country with despotic megalomania, not even in the name of quiet diplomacy or the African liberation movement of old.

Mr. Mbeki is of the view that the UK is to blame for the problems in Zimbabwe and that is disingenuous to the extreme. In fact, what this simply tells us is about leaders in Africa who are seeking African solutions to African problems they have not even begun to understand in any sense.

Expect nothing

If people who are supposed to wield such great influence allow intemperance to dissent to cloud the greater vision of bringing working solutions to the people, we have much to despair about Africa and it is a shame.

It would appear African ministers are only supposed to warm seats and go to international conferences to make Africa a laughing stock and subject us to ridicule, the moment you master your brief to start changing things for the better, the sooner you would be out of a job, because we are never expected to expect anything of our ministers.

Mr. Mbeki however is caught in the limbo between staid Western conservative and African freedom fighter – he is neither and in trying to be either or both we are left with the schizophrenia of leadership and even I would not want to be in the collective where Mr. Mbeki is top-dog.