•NAFDAC, others stretched to limit in battle
The problem of fake drugs has become endemic in Nigeria, with agencies like the National Agency for Drug Administration and Control (NAFDAC) stretched to the limits in their battles against the menace. GBENGA ADERANTI writes on the danger the trend portends considering that many of the vaccines in circulation contain lethal substances.
With two-year-old Shade Adetula down with excessive vomiting, her parents approached a pharmacist who prescribed a drug her parents promptly administered on her in the hope that the vomiting would stop. But rather than abate, her condition deteriorated and she eventually lost her life, leaving her parents shocked and confused that a seemingly innocuous ailment would sniff life out of their little girl.
In 2009 more than 84 Nigerian children died from using a medicine called My Pikin Baby Teething Mixture. A batch of the medicine that went on sale was found to have contained diethylene glycol, an industrial solvent, and an ingredient in antifreeze and brake fluid.
The report said the chemical looks, smells, and tastes like glycerin, a sweet syrup commonly used in a wide range of medicines, foods and toothpaste. Some mindless counterfeiters, therefore, sought to enhance their profits by substituting diethylene glycol for the more expensive but harmless glycerin.
Diethylene glycol, according to medical experts, contains a chemical that causes kidney and liver damage and attacks the central nervous system, causing paralysis that hampers breathing. Sadly, no one suspected that something was amiss until children began to get sick with unexplained fever and vomiting. Some stopped urinating while many others had diarrhea. Most of the children affected in Nigeria were those whose ages ranged between two months and seven years.
According to a report by the World Health Organisation (WHO), four out of 10 patients get ‘harmed’ while seeking medical treatment.
The UN agency warned that the safety of patients during the period of providing them health services is something that should not be taken for granted, noting that most of them die avoidable deaths.
WHO said medication errors alone cost an estimated $42 billion annually while unsafe surgical care procedures cause complications in up to 25 percent of patients resulting in one million deaths during or immediately after surgery annually.
On a daily basis, many Nigerians, infants, children, and adults, die while seeking solutions to their health challenges. But while attention is usually centered on medicines, some of the vaccines they use often worsen their health conditions. The trend is not limited to Nigeria, as many African countries face similar challenges, especially in the use of vaccines.
In a recent report, the United Nations Children and Educational Fund (UNICEF) warned that Nigerian children risk death over poor vaccination. The UN agency revealed that only 36 percent of children aged between 12 and 23 months receive all recommended vaccines, adding that a substantial number of Nigerian children are at risk of death and disability from vaccine-preventable diseases.
Early last year, NAFDAC warned Nigerians to be wary of the fake COVID-19 vaccines in circulation, adding that this could cause COVID-like illnesses and other serious diseases that could kill.
NAFDAC also warned government establishments and agencies, as well as private companies and big corporations, against ordering the vaccines without its approval, noting that COVID-19 vaccines are new and the side effects or adverse events must be well monitored; hence should not be used by the public.
“There are reports of fake vaccines in Nigeria and these vaccines can cause COVID-like illnesses or other serious diseases that could kill. No government establishment or agency, company, or corporation should order COVID-19 vaccines without confirming from NAFDAC if the vaccines have been approved.
“COVID-19 vaccines are new and the side effects or adverse events must be well monitored. Therefore, if NAFDAC does not approve, the public should not use,” the agency said.
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In 2016, Nigerian children received 450 million out of a total of 2.5 billion doses of vaccines procured by UNICEF for children in nearly 100 countries. Good as the vaccines may be, an environmental expert and a Professor of Health Physics and Environment at the Obafemi Awolowo University, (OAU), Ile-Ife, Osun State, Prof. Joshua Ojo, has warned of the dire consequences of the current practice where several frequently administered childhood vaccines are deliberately loaded with mercury used as a preservative in the multi-dose format. This format was banned 30 years ago in Europe and over 20 years ago in America.
The 40% content of the mercuric compound known as thimerosal, translates to an incredible 50,000 times the recommended maximum limit for mercury in wastewater that can be used for agricultural (irrigation) purposes!
This, the professor said, was based on recommendations stemming from risk assessment exercises carried out by foreign/global agencies. Vaccines so affected include Hepatitis B and Tetanus-Diphteria multidose vaccines. Mercury in all forms is known to be neurotoxic.
“By switching to single-dose forms of the same vaccine, as is done in the developed countries, the need for the use of thimerosal (as a preservative) will be eliminated,” he opined.
During the 7th National Conference on Environment and Health (organised by the LivingScience Foundation, Ile-Ife CAC/IT/91834) at The Redeemer University, Ede, Osun State, Nigeria, with the theme: Environmental-Health Risk Assessment and Sustainable Development in Nigeria, the stakeholders had recommended that thimerosal-containing vaccines packed in multi-dose vials should be phased out immediately. Government, it said, should facilitate this by providing a modest increase in budget that would enable their replacement with single-dose ampoules that do not require preservatives, as is the case in the developed nations of the world.
Ojo said until people are bold enough, to tell the truth that is inconvenient for the ‘powers that be,’ many Nigerians would continue to die. He argued that many are afraid to challenge vaccines in the present dispensation in order not to be tagged as promoting ‘vaccine hesitancy.’
In some quarters, it has been argued that most of the developing countries are too impoverished to afford safer single-dose vaccines, but Ojo dispelled this, saying “there’s actually no such nation.”
According to him, “the vaccines are most certainly overpriced, sold to us (developing countries) at dubious discounts while every effort at local production was viciously frustrated by these foreign powers.”
Unknown to many, Nigeria was producing its own vaccines before it was sabotaged and had to be stopped. There was the Federal Vaccine Production Laboratory in Yaba, Lagos which was locally producing vaccines in Nigeria until it was shut in 1991.
All things being equal, Nigeria may resume production of its vaccines by 2024. In August this year, Indonesia’s Ambassador to Nigeria, Usra Harahap, met with the top executive of Biovaccines Nigeria Limited, a Joint Venture (JV) between the Federal Government and May & Baker Nigeria Plc in Lagos, on the status of their existing partnership and the modality of scaling up the country’s vaccine production capability.
Harahap said Indonesia “is willing to work with Nigeria to develop the needed local capacity” to achieve vaccine sovereignty in no distant time.
The government had committed N10 billion ($26,315,789) to the project.
Professor Ojo would not be categorical on why developed countries would continue to bring vaccines that contain some percentage of mercury into the developing world, but he was of the opinion that “on the surface, selling some of these vaccines in mercury-laden multi-dose format increases profits, as it brings down production costs. But I believe there might be other factors and interests.”
He warned that this may be difficult to stop because it is more of international politics and economics.
He said: “Key government officials (and professionals in the non-governmental sectors) are corrupted by one inducement or the other; others are blackmailed, and a few strong-headed ones could be threatened into keeping quiet.
“Can you imagine NAFDAC writing their original article trying to defend mercury in childhood vaccines? And then they have been unable to respond to our article? And worst of all, no media house (apart from 1 or 2) among the nearly 40 that carried NAFDAC’s statement is showing any further interest in the matter and asking NAFDAC for a response!”
According to the professor, the presence of mercury in vaccines could cause problems to the kidney and the liver.
During World Kidney Day (WKD) in March, experts said more than 20 million Nigerians are living with kidney disease and no fewer than 20,000 of the number are coming down with End Stage Kidney Disease (ESKD) yearly requiring dialysis or/and transplant to stay alive, according to medical experts.
As at 2016, According to a former President of the Nigerian Association of Nephrology (NAN), Dr. Ebun Bamgboye, 17,000 kidney failure cases were diagnosed annually in Nigeria. The country has one of the largest burdens of kidney disease in the world.
Other negative impacts of vaccines with mercury in the human system, according to Ojo, include brain development, leading to a wide spectrum of effects including autism, issues with memory, and neurological issues including poor coordination between the brain and hands/feet (ataxia) among others.
The way forward
Proffering the way forward Ojo advised the Nigerian government to proscribe mercury-containing vaccines, insist on the single-dose format, and negotiate a realistic price.
He said: “Vaccines are meant to prevent diseases. There are other options such as the provision of clean water and good sanitation. If the vaccine sellers insist on unreasonably hyped prices, we should shift our attention and money to other options, including local production of the vaccines.
“Without a well-informed public, the government will not be able to resist external pressures.
“A good example is the case of same-sex marriage. Despite enormous external pressure, it is a no-go area for governments because Nigerians are well aware of the issue, and are united in their strong opposition to it.”
No mercury in children’s vaccines– NAFDAC
Earlier, the National Agency for Food and Drug Administration and Control denied that children in Nigeria were given a vaccine containing 40% mercury, as prescribed by foreign organisations.
According to a press statement by its former Director- General, Prof. Mojisola Adeyeye, mercury is a metal and it is not used as an element or as a component of vaccines.
“Thimerosal, a mercuric compound used as a preservative in multi-dose vaccines, contains a different form of mercury known as ethyl mercury,” according to the statement.
“Thimerosal is used as a vaccine preservative in concentrations ranging from 0.003 per cent to 0.01 per cent” (for example, thimerosal content allowed in vaccines is between 30 parts and a maximum of 100 parts out of million parts of the vaccine formula).
“Thimerosal is a mercury-based preservative that has been used in multi-dose vials (vials containing more than one dose) of medicines and vaccines in the United States for decades.
“With the exception of minor reactions like redness and swelling at the injection site, there is no evidence of harm caused by low doses of thimerosal in vaccines.”
However, in July 1999, the Public Health Service, the American Academy of Paediatrics, and vaccine manufacturers agreed that thimerosal in vaccines should be reduced or eliminated as a precautionary measure.
“Thimerosal is still used in some multi-dose vaccines in Nigeria, but at a safe level. However, due to a lack of evidence that thimerosal poses a risk to human health, the World Health Organization has not prohibited its use as an inactivating agent and preservative in vaccines.”
However, NAFDAC has failed to respond to Prof Ojo’s refutation of this press statement. Ojo had pointed out, from the agency’s website, that NAFDAC has zero-tolerance for any form of mercury in any product under its regulation.
“Any product, except, one – childhood vaccines! This is difficult to comprehend seeing that children constitute the most vulnerable segment of society and need to be more stringently protected,” Ojo said, quoting from NAFDAC website.