Oral Polio Controversy

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SANI T. IBRAHIM
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 OPV:WHAT PEOPLE DID NOT KNOW  
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OPV: What People Did Not Know

By

Sani Ibrahim

sitaura69@yahoo.com

 

Even to the most casual observer, aside the past Pfizer/Trovan controversy and a few sundry others, the most dangerous of health related controversy that recently engulfed the nation state and more especially the Northern part of Nigeria is the Oral Polio Vaccine (OPV) controversy.  

The controversy in itself has a lot of repercussions – the danger it will pose to the nation in the long run is unquantifiable considering that the issues involved are bordering on life and death and is hanging on the future of our children – the mothers, scholars, subjects and leaders of tomorrow. God and posterity will therefore never forgive any body who knows no matter how little, yet through his actions and inactions, keeps mute over this future – generation – afflicting controversy. The multidimensional controversy therefore ought to be treated scientifically, professionally and intellectually. It is in view of that, the confident with my little analytical skills, little knowledge in science and little writing skills that I felt burdened to investigate and air my views about the ravaging controversy.  

 

GENESIS  

The controversy is all about the safety or otherwise of the vaccine as regards its chemical constituents. There are the rejectionists, mainly from the predominantly Muslim states of some part of the north who believe that the vaccine is laced with antifertility hormone and human immunodeficiency virus (HIV/AIDS). Investigations reveal that, the controversy all started when a site in the internet had information that revealed that the OPV administered worldwide is contaminated with traces of Oestrodiol – an antifertility hormone. Although the trace level was not disclosed, how and why it all came about, that mere revelation online aroused, a lot of suspicion from within to an extent that the Dr. Datti led campaign brought the apprehension in to public glare at numerous media campaigns – aroused suspicion and anger from some interest groups led by some traditional rulers in the north who inadvertently call the attention of all stakeholders and advised for the suspension of patronage of the vaccine from their domain. The fears been expressed is that since Oestrodiol is an antifertility hormone, its presence in a massively campaigned immunization connotes a hidden agenda from a particular interest group plotting/conspiring to depopulate a segment of the population-the Muslim North.  

 

The proponents of the use of OPV however, is mainly the Global Polio Eradication Initiative(GPEI)-WHO, UNICEF, Rotary international and US Centre for disease Control and Prevention (CDC) on one hand and the federal government, NAFDAC, NPI on the other hand who, based on their knowledge of manufacturers/manufacturing practice and their independent tests/confirmations allays non of such fears expressed by the rejectionists, reaffirming the safety of the vaccine.  

 

HISTORY  

 

Formerly called Sabin vaccine, OPV is an aqueous suspension of suitable strains of poliomyelitis virus, type 1, 2 and 3, grown in cultures of monkey kidney tissue and inactivated by a suitable method. It contains soluble bactericides and preservatives. It is administered to prevent the highly infectious disease called poliomyletis-caused by a virus that infects the nervous system and cause total, irreversible paralysis or kill in a matter of hours.  

 

OPV was developed in the 1950s and was approved for use 40 years ago, according to WHO/UNICEF's source. Since 1988, over five billion doses of pre-qualified OPV have been administered to over one billion children worldwide during mass immunization campaign, as part of the global effort to eradicate polio. In the year 2001, 575 million children were immunized in 94 countries, in Afghanistan and Pakistan alone, 35 million were immunized and in West Africa, over 60 million were immunized during synchronized National Immunization Days(SNIDs) in 17 countries.  

 

Only three countries in the world-India, Pakistan and Nigeria-remain as the last reservoirs of wild poliovirus in the world. India and Pakistan have significant level of interruption, but Nigeria is posing a danger against the campaign -50% polio cases globally and 85% of cases in Africa in 2003 occurred in Nigeria. As of mid-2003, Nigeria is the worst affected with 287 cases so far this year. According to the same source as above, two west African countries-Nigeria and Niger now account for well over half the world's total polio caseload.  

 

Kano state, has 81 current cases, followed by Kebbi (37), Katsina (33), Bauchi (27) and Jigawa (23), remains the epicenter of Poliovirus transmission globally. Kano has even exported cases to Ghana (6), Chad (1), Niger (1), Togo (1) and Burkina-Faso according to the WHO sources.  

 

It is scientifically proved, according to the above source that in every case detected in a community, there are 200 infected cases undetected capable of spreading the disease to other children.  


Their reported adverse effect shows also that between 1962 and 1968 among the over 11 million newborn infants vaccinated, 36 developed vaccine related Poliomyelitis (1in 4 million doses).  

 

UN procured OPV for Polio eradication campaigns has been pre-qualified by WHO and is produced by four manufacturers in Belgium, France, Indonesia and Italy.  

 

FEARS EXPRESSED BY REJECTIONISTS.  

 

Those opposing the administration of OPV are expressing their reservation that the OPV sample sent to their domain contains antifertility hormones as contaminants in the samples, and that it was grand designed by western imperialist and their local collaborators to depopulate their wards by rendering them impotent in the long run. It is mostly from the Muslim North-their traditional rulers and governors are in the vanguard against the campaign. This allegation looks more likely and more convincing when one refers back to the Pfizer/Trovan controversy, when some children in Kano were used as guinea figs to test new drug(Trovan)-purportedly newly synthesized by Pfizer- under the cover of their local collaborators, a situation that resulted in death of the innocent children.  

 

Infact, the huge amount of money earmarked for the OPV campaign, ranging to about $1.5 billion, and the Nigerian stakeholders’ visible extravagance in the mass campaign amidst poverty, HIV, malaria, measles among several other diseases smacks of a hidden agenda from the initiators of the misplaced priority; according to the belief of the rejectionists.  

 

The hue and cry prompted the setting up of an Independent team of investigation first by the Kano State government headed by Dr. Lawal Bichi, with the test conducted in Nigeria. The second test was organised by Jamaatu Nasril Islam(JNI)- a Muslim umbrella body that conducted its own test in India under the Chairmanship of Dr. Haruna Kaita- Dean of Pharmacy, ABU Zari’a.  


The test results of both teams aforementioned confirmed the presence of antifertility hormones in varying proportions as ‘contaminants’ in numerous samples not labelled by their manufacturers. This therefore heightened the fears of the rejectionists, aggravating the already charged atmosphere, culminating in to calling for its suspension by lots of interest groups particularly by the Kano state government until something is proved to the contrary.  

 

CLAIMS BY THOSE AFFIRMING ITS SAFETY  

 

Federal Government of Nigeria was, for the umpteenth time worried by the counter claims against the vaccine and the rejectionists’ fears. It setup an independent committee of investigation headed by a Muslim, a veteran epidemiologist, Professor with medical experience spanning over 55 years. His team conducted test in numerous laboratories both in the country and abroad. Their test result did not reveal the presence of any ‘contaminant’ in the OPV samples; reaffirming its safety. Equally, under the instruction of federal government, several tests were conducted by NAFDAC, NIPRD and Dr.Abdulmumini Rafindadi-an ABUTH pathologist, a WHO consultant that equally revealed that OPV is infact safe for use by Nigerian children.  

 

The federal government team unfortunately did not include any of personality introduced/recognized by the rejectionists, a singular action that worsened suspicion, heightened enmity and contributed to renewed controversy.  

 

But the borne of contention here is that, for the fact that the test results of those affirming its safety do disclose that some samples are actually not devoid of some traces of Estrodiol in negligible quantity considered insignificant by them, such trace level were either not disclosed to the public, or the reason for its presence are not properly explained to the listening ears convincingly. An unofficially released, purportedly disclosed as NAFDAC test result (no any NAFDAC staff signatory) and published in the weekly trust newspaper in its March 6-12th edition on page 4 is a case in point.  

 

SOME OTHER CLAIMS BY PROPONENTS  

One among the vocal opposition of the OPV was alleged to have been a father of an employee of a donor agency who was shortly before his vocal opposition to the OPV sacked as result of fraud and embezzlement. She was said to have took it up against her employer through her father, an influential Northern elite, Opinion molder and a traditional title holder, member of JNI and Supreme council for Shari’a in Nigeria.  

 

Another is the polio politics theory advanced from those who believe that certain interest groups were against the present leadership of NPI headed by a Yoruba in a predominantly Yoruba settlement at the helm of affairs, hence the blackmail as the cheapest weapon of dethroning.  

 

ANALYSIS OF RESULT DECLARED BY REJECTIONISTS  

A scientific analysis of the test results as revealed by both parties will be of immense benefit to those who didn’t know the fact on ground, considering the level of ignorance of scientific issues by majority of the people in diaspora.  

 

According to Dr. Kaita’s findings published in Albishak column of New Nigerian edition of Thursday February 12th -the only result available with me, which I believe, Dr. Bichi and co will not begrudge revealed the following:-  

 

A.  Dr. Haruna uses three(3) tests for his confirmations-High Performance Thin layer Chromatography(HPTLC), RadioImmunoAssay(RIA) and Gas chromatography-mass spectroscopy(GC-MS). The first test reveals negative results up to sample concentrations of 2000ppm. The second detected Estrodiol at various proportions as follows:-  

 

Sample amount interpretation  

KDS1-10 54.7pg/ml  0.0000000000547g/ml  

SKT1-18    39.09pg/ml  0.00000000003909g/ml  

SKT2-10 36.30pg/ml 0.00000000003630g/ml  

SKT3-10   46.79pg/ml  0.00000000004679g/ml  

ZFS1-10 54.00pg/ml 0.000000000054g/ml  

ZFS2-10   45.54pg/ml  0.00000000004554g/ml  

ZFS3-10   46.08pg/ml  0.00000000004608g/ml  

 

B.The third test confirms the presence of Estrogen in each sample labeled and indicated along side it as follows:-

KDS1-10: a-androstenone,anostadienetriol,cholestenone,octadecanoic acid.  

SKT1-8:Cholestenone,Octadecanoic acid.  

SKT3-10:Campesterol,cholestenone,b-sitosterol,lanosterol,a-amyrin,b-amyr in,lupeol.  

ZFS2-10: Octadecanoic acid, pragnadiene,cardadienolide,ethyl iso-allocholate.  

ZFS5-10 prognadiene,lanostadiene,cardadienolide.  

 

The above test results therefore confirms the contamination of OPV by Dr. Kaita’s result with Oestrogenic hormones and its derivatives, Estrodiol of which is the most active, and its issue on the antifertility theory the most contentious.  

 

I will therefore analyses the second test above that confirmed the presence of Estrodiol to see if it has any scientific bases.  


WHAT IS OESTRODIOL?  

An authoratative text in Pharmacy within my rich -the Martingdale’s Extrapharmacopeia, Oestradiol(Estradiol(USFN) is the most active naturally occurring Oestrogenic hormones formed in the Ovarian follicles under the influence of the pituitary. It controls the development and maintainance of the female sex organs, the secondary sex characteristics and the mammary gland etc.  

 

Low physiological amounts stimulate gonadotrophic and lactogenic activities of the anterior pituitary, but large amount depresses these activities. In late pregnancy, it increases the spontaneous activity of the uterine muscle and its response to oxytocid drugs. the additional activity of progestoterone is essential for the complete biological function of the female sex organs.  

 

WHAT IS THE RECOMMENDED EFFECTIVE DOSE OF ESTRODIOL?  

According to Martindale, an adult dose of 0.22-1.5mg/ml by injection twice or thrice weekly, 200-500microgram (0.2-0.5mg) once to thrice daily orally is recommended. However, according to British National Formulary (BNF) 37 page 10, a one (1)-year old child weighing 10kg, with 76cm height and a body surface area of 0.47m2 will receive 25% of adult dose or 0.05-0.125mg oral. Whereas a five (5) –year old boy with 18kg body weight,108 cm height,0.73m2 surface area is to receive 40% of adult dose equivalent to 0.08-0.2mg.  

WHAT IS THE USE OF ESTRODIOL?  

 

At the recommended adult dose above, Estrodiol is used in the treatment of antifertility related cases like primary amenorrhea, management of menopausal syndrome, treatment of habitual abortion, treatment of postcoital contraception (in high doses), given in combination with progestogens for the control of conception (as in contraceptives), treatment of dysfunctional uterine bleeding, dysmenorrhea and treatment of menstrual irregularities ( as in oral contraceptives)etc.  

 

Oestrogenic hormones are visibly included in a lot of steroid for menopausal symptoms and hormone replacement therapy in ovarian failure like PRIMOGYN DEPOT,MENSTROGEN, GYAENOCOSID etc and is used by patients for the treatment of various fertility-related-ailments with some side effects and without long-term inducement of infertility in majority of cases.  

 

WHAT IS THE ABSORPTION AND FATE OF ESTRODIOL?  

According to Martindale, Estradiol upon intake is partly bound to plasma proteins and rapidly metabolized in the liver to the less active Oestriol and Oestrone. It is absorbed from the GIT through the skin, excreted in the urine as sulphate and glucoranate esters, together with a small proportion of unchanged Oestrodiol.It is excreated in bile and undergoes reabsorption following hydrolysis. It is also excreated in the milk of nursing mothers.  

The above explanations therefore confirms that Estrodiol does not stay/accumulate permanently in ones GIT(stomach).  

 

IS THE CONTAMINATED OPV INSIGNIFICANT TO CAUSE INFERTILITY?  

According to Dr. Kaita’s sample, a five-(5)-year old child in the street of Kaduna, administered with drops of KDS1-10 OPV is vulnerable to a contaminant of 0.00000000005457g/ml Estrodiol in his GIT. But as aforesaid, the maximum effective dose that can cause any serious effect(either harmful or useful) to the child is 0.08-0.2mg(0.0008-0.002g) orally or 0.22-1.5mg (0.0022-0.15g)/ml by injection.  

 

It is therefore clear that by simple arithmetic, KDS1-10 OPV administered to a five-year old child in the street of Kaduna will have to multiply up to 36650174 (Thirty Six Million Six hundred and Fifty Thousand One Hundred and Seventy Four) times in his GIT in order to reach up to the effective dose of 0.002g.(0.000000005457x36650174=0.02) that can cause any serious desirable or undesirable effect(infertility).  

 

And in any case it has been proved in many scientific evidence and authorities as regards the absorption and fate of Estrodiol as aforesaid that Estrodiol is metabolisable and reduced to inactive form and can be excreted hence can not accumulate in the GIT of a child so as to cause any effect in the long run. Other evidence revealed the impossibility for hormones to remain unmetabolised for months, but with chemotherapeutic agents used for the treatment of cancer. These drugs can destroy sex organs with prolonged use.  

 

An article published by one Dr. Nura Alkali from Institute of Noeurology, National hospital for Neurology and Neurosurgery, London, UK in the Gamji website revealed the no any drug exists that can be surreptitiously given to an infant by mouth in order to make him/ her sterile later in life.  

 

CONCLUSION IN THIS REGARD.  

 

Those affirming the insignificant of level of contamination are right. At a level of Picogram in weight when dealing with the contaminants in question, none of the samples tested with such level of contamination can cause any serious effect, and particularly when dealing with substances of which in either case is metabolisable to its inactive form and can be eliminated via excretion as explained above at such trace level is ineffective.

 

 

BUT WHAT CAUSES THE TRACE LEVEL TO WARRANT DECLARING IT INSIGNIFICANT?  

What constitutes the fear of the rejectionists that there are more questions unanswered as to what constitute a medical preparation involving a health campaign that has to do with generation of children in a community that lost confidence in the ability of its leadership to improve their lot in health matters; if such leadership will be bold enough to declare an ‘insignificant level of contamination.’  

 

Three issues are at stake here: the contaminant is not a preservative, bactericide, solvent, diluents or binder which was not disclosed by the manufacturers in the label, its presence no matter how insignificant smacks of a hidden agenda from manufacturers.  

Or that the manufacturers are unprofessional and hence unreliable to warrant the usage of their products, because in the long run something more devastating by their products may likely be in the offing. Or that unreliable/faulty equipment that is not standardized is used, or that faulty procedures are employed to arrive at the wrong conclusion.  

 

However, The federal government independent panel of expert headed by professor Shehu Umar that employed double gas chromatography, and mass spectrometry methodologies had confirmed that the trace level readings picked up in both are the automatic result of high sensitivity laboratory conditions, and constitute the kind of low-level ‘background noise’ common across all analysis of the technical accuracy. The expert panel therefore decrees that these background readings are the cause of false positive results observed during domestic tests.  

RISK-BENEFIT ANALYSIS.  

Northern part of Nigeria is left with two options: either to establish the veracity of the claims that OPV administered to its people for a time immemorial is contaminated and hence harmful and face the risk of total rejection of other Immunization programme(including even the usage of other orthodox drugs) because of some scientific ignorance and the conservative nature of majority of its people and hence along run ripple effect, or allow for a scientific approach to takes its course by reputable scientist to declare if at all, the level of contamination is worth its total rejection.  

 

Immunisation boycots might have been the cause of several reported cases of measles and meningitis outbrake in Jigawa and Sokoto states as at the time of writing this piece.  

 

It is no doubt that OPV has been used world over, in Islamic nations of Afghanistan, Pakistan and India and in Northern Nigeria for historic periods aforementioned, it is therefore mandatory that its longitudinal usage be analyzed, the benefit of its usefulness ought to outweigh the possible risk; the risk of its usage bordering on the belief that it is laced with contaminants and other associated risks as well as the benefit derivable from its usage in terms of preventing an ailment capable of causing an irreversible damage to its victims etc.  

 

Poliomyelitis is a serious disease that causes total, irreversible paralysis in a matter of hours causing permanent deformity to its victims. The only preventable drug is the OPV and it has no curative remedy. Like any other vaccine OPV in the blood stimulates the formation of antibodies and also produces resistances in the intestinal tissues to infection with virulent poliomyelitis virus. In itself, it has a lot of side effects and contraindications typical of other drugs as even revealed by its manufacturers, ranging from the cause of the polio itself, congenital abnormalities, and infection from vaccinated contacts etc, all of which are seen in some not all cases as evident with any other orthodox drugs.  

 

It is contraindicated to people taking long-term steroids or any other drug that affects the immune system, anyone who has AIDS or HIV infection or any other disease that affects the immune system (see www.immunize.org/vis/opv-ov.pdf).  

 

For a single case of a devastating disease that causes the possible contamination of 200 others in a community not adequately provided with effective health care delivery, it will be suicidal to declare the usage of the only possible remedy as unsafe based on the fact that the claim of the level of contaminant is insignificant to cause any harm.  

 

QUESTIONS THAT ARE LEFT UNANSWERED?  

For the fact that the level of contamination is proved scientifically in significant and considering the danger this issue will pose to the generally of Northern leaders of tomorrow, why should our so called scientist deliberately decide to maintain a deep ears and blind eye over health issues bordering on life and death of children?  

 

The claim by proponents that trace level is as a result of low –level “background noise” of a false positive result as a result of highly sensitive laboratory conditions is medically feasible. Similar incidences were obtained in some tests results. NAFDAC’s test result aforesaid, if analyzed as in Dr. Kaita’s sample above, will actually show that the trace level is actually insignificant and may be as result of highly sensitive laboratory conditions leading to the false positive result; then why should our scientists describe a test result of a contaminant to such an insignificant level as harmful, cytotoxic, carcinogenic, infertility-inducing etc knowing very well that is not scientifically or even medically tenable/verifiable? Can one finally infer that it is actually polio politics? Or is it the vindictiveness by a father as a result of the iniquity of the son?  

CONCLUSIONS  

Polio eradication is actually expensive and cumbersome, but it is justified that according to investigations Small pox has been eradicated using the same system applying the same programme and today is history, no traces of small pox is ever seen world over. Bill gates is now employing $2.8 billion commitment towards AIDS eradication. The argument that huge some is committed towards this programme in mass campaign smacks of a suspicion of a hidden agenda is untenable. That is how philanthropists in the developed world aid/assist towards the improvement of humanity, sharply different from Nigerians, were such a gesture is still not a norm, and in fact appears impossible/impractical to undertake.  

 

It doesn’t matter if one will fill the whole newspaper quoting literatures that the vaccine in contention has side effects. It is medically proved that no drug is free of side effects/contraindications. All orthodox medicaments including vaccines, if subjected to deep scrutiny will reveal a lot of cases of side effects/possible relapses or resistances.  

 

Finally, since the fundamental issue is premised on the need to establish the presence or otherwise of a contaminant in OPV samples at a harmful level, any scientific findings that cannot prove in concrete terms any of the above premise is rejectable. And any scientific prove that can reveal lack of contamination, or in fact the reason behind an insignificant trace level with a convincing scientific proof acceptable should be condoned. This should be the burden that our scientist ought to shoulder.  

 

In trying to establish conspiracy against it, the North should be wary of plotting to conspire against itself. The North should not afford to leave with Politico-scientists.  

 

SANI T. IBRAHIM  

DUTSE, JIGAWA STATE.