MINISTER of HEALTH’S STATEMENT AT THE NATIONAL ASSEMBLY EXTRAORDINARY SESSION ON ACUTE KIDNEY INJURY
26TH OCT 2022
Distinguished Honorable Speaker and National Assembly Members. Thank you very much for inviting my team and I to this extraordinary session of the National Assembly on the death of children due to Acute Kidney Injury (AKI). I acknowledge the presence of colleague Honorable Ministers, my other colleagues and other distinguished individuals here.
We would like to extend our condolences to all the families affected and pray that Allah grants all the departed children Al Jannatul Firdaus, amen. This period has been difficult for the families of the children, and we pray that Allah grants them the fortitude to bear their loss. We also commiserate with the healthcare workers who were taking care of these patients and did all they could to save their lives but ended up losing them.
This year, The Gambia experienced the highest amount of rainfall in over 15 years. There had been windstorms and floods in many parts of the country. There are numerous diseases that become common during the rainy season either because the vectors carrying such disease-causing microorganisms thrive and reproduce well in stagnant rainwater [because] such water serves as a conduit for the transmission of water-borne diseases.
These diseases could be viral, bacterial or parasitic. For this reason, each year, during the rainy season diseases such as Cholera, Salmonellosis or other bacterial diarrhoeal diseases, viral diarrhoeal diseases, malaria, skin diseases etc are all commoner. This year is no exception. Floods are known to worsen this problem and that is one of the most important causes of mortalities when it comes to floods. The fact is that there could be physical injury to the flood victims coupled with the high potential for disease outbreaks.
In July 2022 the Ministry of Health received information from the doctors at the Pediatric department of the Edward Francis Small Teaching Hospital (EFSTH), that they were seeing an increased number of children under 5 years of age who were presenting with symptoms of AKI. This information was conveyed to the Epidemiology and Disease Control unit of the Ministry of Health, whose mandate it is to conduct surveillance and control diseases of public health concern. An Incident Management System was set up to look into the AKI issue.
AKI is the sudden deterioration of the functions of the kidneys which manifests with the symptom of oliguria (diminished urination) or anuria (production of no urine at all) among others. The injury to the kidneys may affect other homeostatic functions of the kidneys. This may coexist with or lead to other organ damage.
AKI can be classified as community-acquired AKI or hospital-acquired AKI. Every country has its baseline level of AKI. These figures vary from one geographical location to the other, from country to country and from one health facility to the other within the same country.
AKI in children has numerous causes. These causes can be broadly classified into 3: pre-renal, Renal and Postrenal. Renal refers to the kidneys.
The pre-renal causes of AKI in children especially in the tropics are:
1. Acute gastroenteritis – associated with severe vomiting and diarrhoea
2. Complicated malaria
3. Sickle cell disease
4. Severe dehydration
The renal causes of AKI are:
1. Acute tubular necrosis
2. Acute HaemolyticuraemicSyndrome
Factors causing these could be nephrotoxic medications, toxins, sepsis etc
The post-renal causes of AKI are:
1. Obstruction in the ureters
2. Obstruction in the bladder
3. Obstruction at the urethra
Factors causing these could be stones, tumours, congenital malformations and etc.
From the outset, it was clear that the possible causes of AKI in these children were many. Most of these children had a history of diarrhoea and vomiting, fever and some of them had coughs. These children were referred from all 6 health regions of the country. These were the regions where floods had also been reported. The only region where there was no referred case was the North Bank East health region where there was no or minimal flooding.
These made the clinicians arrive at the suspicion that they were dealing with an outbreak of AKI that might have arisen because of contamination of sources of water and food in the communities. We had seen communities where water levels were so high that they submerged the pit latrines and the wells thereby giving rise to contamination of the sources of drinking water. The possibility of diarrhoea and vomiting causing AKI was entertained. Health workers were dispatched to the communities to take water samples for analysis. It is important to note that some of these samples when tested yielded Escherichia Coli (E Coli) which is one of the commonest causes of diarrhoea and vomiting in children. Severe diarrhoea and vomiting by themselves can cause AKI. Some strains of E Coli can cause hemolytic-uremic Syndrome, which can also lead to AKI. Further analysis by sequencing of the bacteria isolates indicated the presence EscherichiaFagusinii. The bacteria also has the potential to cause haemolytic uremic syndrome which can also lead to AKI.
As all this was happening, the clinicians were seeing more children with AKI.
In our newly established postgraduate training programme at the EFSTH, with the support of the world bank, We have employed 16 senior doctors at the EFSTH, including a professor of pediatric nephrology ( this is a professor of Kidney Disease in children). We also now have a Gambian Nephrologist (kidney disease specialist) at the EFSTH. The experience of this professor in Nigeria and the information given in other countries like Bangladesh, Panama, Pakistan, Haiti etc. increased the clinical judgement of the team of clinicians that the potential of contaminated medicines causing AKI should also be explored. This is coupled with the observation that many of these children were also given various medications and many of them were similar. These children continue to receive treatment – peritoneal dialysis and supportive treatment. The mortality rate was however high.
This finding was reported to the World Health Organisation (WHO) country office and we also requested for support to deal with the investigation.
Since we have capacity challenges in our public health laboratory and we do not have a full-fledged drug testing laboratory, with the support of the World Health Organization, blood and stool samples were sent to WHO-accredited laboratories in Senegal to help in the identification of any pathogens and/or contaminants in the stool, blood and medication samples. The process was tedious but was however accompanied by rigorous follow-up. The results yielded proof of E Coli in stool samples sent. Two of the samples sent yielded E Coli serotypes 0157 which is a Shiga toxin-producing E Coli. Shiga toxin is known to cause haemolytic uraemic syndrome which can cause AKI.
As the clinical correlation between children taking the medications and the worsening of their symptoms and the development of AKI became more suggestive, the incident management committee advised for the suspension of the use of paracetamol syrup in the country. This was the main suspected drug because of the historical knowledge and the fact that about 80% of the affected children at the time had consumed paracetamol syrup. This was shortly followed by the suspension of promethazine syrup as well.
This move was even criticized by many people saying that we did not have enough evidence to do so. It however proved to be a good decision. Some further drug samples were sent to Ghana for analysis. The preliminary results from Ghana indicated that out of the nine samples one paracetamol and one promethazine syrup were found to have contaminants. Paracetamol had diethyl glycol (DEG) and promethazine had both ethylene glycol (EG) and DEG. All samples were found to have an unknown compound.
The quantification of the results showed high levels but the paracetamol could not be further tested due to an inadequate sample for analysis.
However, confirmatory reports could not be obtained from there. This was followed by the instruction from the Medicines Control Agency to quarantine all these products in the pharmacies and warehouses.
Further analysis of the samples in Switzerland indicated that four of the medication had high levels of ethylene glycol and diethylene glycol (Makoff Baby Cough Syrup, Magrib N Cold Syrup, Kofexmalin baby Cough Syrup and Promethazine Oral Solution). These were industrial chemicals that are toxic to human beings. They are used in car antifreeze systems and brake fluids. The presence of these compounds in the medications is a gross violation of good manufacturing practices (GMP). These syrups were manufactured by Maiden Pharmaceuticals in India and were imported by Atlantic Pharmaceutical Company to The Gambia. A massive withdrawal exercise of these drugs was commenced including household recall of all syrups. A total of 50,000 bottles of the contaminated syrups were imported and 42,173 were collected through the recall exercise so far.
Distinguished honourable speaker, our government has been working very hard over the years to reduce morbidity and mortality in The Gambia. In this vein, the government has embarked upon health facility expansion, provision of more laboratory and other equipment and massive capacity-building exercises. This is yielding results with a very significant reduction in maternal mortality from 433/100,000 live births in 2013 to 289/100,000 live births in 2019/2022, and a reduction of under 5 mortality from 54/1000 in 2020 to 49.4/1000 in 2020.
It, therefore, came as a big blow to have lost 70 children below the age of 7 to AKI. In 4 months 7 of them passed away in Senegal. A total number of 82 AKI cases were diagnosed and 12 recovered This has been a very difficult moment for the families to whom we extend our deepest condolences. It has equally been a very difficult time for his excellency the President, the entire cabinet and the people of this country. For the staff taking care of these patients and all other staff, it has been a traumatizing experience.
Our experts and their teams worked diligently round the clock to save the lives of these patients.
During this period, peritoneal dialysis capacity was enhanced and required materials were procured. Emergency medications and equipment including 2 dialysis machines for children were also procured by the government and WHO. These have been very helpful.
Throughout the period, many technical incident management meetings were held to map out the way forward. On our request, the World Health Organization and the Centre for Disease Control (United States of America) sent in technical experts at various points for support and advice. This included the WHO Africa Regional Emergency Director, The Director for drugs and Medical Supplies, the Regional Incident Management Director, the causality expert, data management experts and many more.
CDC (USA) who sent in 4 experts including one infectious disease specialist, two epidemiologists and one anthropologist.
Some of these experts are still around working with our own experts. They have been working diligently both in the health facilities and in the communities collecting the relevant information and data to help in bringing this outbreak to an end and to help determine the cause of the outbreak and also the cause or causes of the mortalities.
From the foregoing, it is very clear that this is not a simple process. All the probabilities have to be scientifically looked into before one can conclude what the cause of death is. That actually means that this has to be established in a scientific way without doubt of the causality or causalities of death in these children. It should not be forgotten that the contaminated drugs are the most suspected but other possible causes like severe diarrhoea and vomiting, bacterial infections, and complicated malaria are possible causes.
Distinguished honourable Speaker and National assembly members, the issue of counterfeit or substandard medicines is a massive global problem.
It is a multibillion-dollar entity in which some selfish individuals thrive on the suffering of people. The food and drug administration of the United States of America in 2002 withdrew over 1200 dangerous medicines from the American market. It is a big challenge for the entire world, especially for poor developing countries like ours where all drugs have to be imported and we have both limited human and material resources to detect the problem. Cases of counterfeiters doing their manufacturing in boats offshore where no one can ever identify the origin of the drugs have been reported in some other parts of the world.
Upon announcing the issue of the AKI that is in the Gambia, the alert of countries around the world was increased and this has led to the discovery of a similar phenomenon in Indonesia where 208 cases of AKI were so far detected with a mortality of 133.
Distinguished honourable Speaker and national assembly members, Indonesia is considered to be a middle-income country with many facilities and personnel for detecting AKI and substandard medicines in their population. The fact they had to take a cue from us here in the Gambia and even consult our team to share our experience with them for them to deal with this problem means our team in The Gambia has really put in our best. A similar incident occurred in Haiti were 109 children passed away. This is by no means trying to justify what happened in our country. It is just to dilate on the challenges developing countries face. It is important to note the identification of the problem and the actions our government took to stop the problem are remarkable by international standards. This has potentially saved a lot of other lives. We have not seen any new cases for 2 weeks in a row.
Detecting outbreaks of this nature that have multiple possible causes is very challenging, especially for developing countries. During this outbreak, the World Bank has agreed to construct a drug and food testing laboratory for us in the country as there is also no food testing laboratory in the country. Preliminary work has started to this effect.
Distinguished honourable Speaker and National Assembly members, I believe that our country has been assaulted, this is an aggression against our people from greedy unscrupulous people. The manufacturing, distribution and importation of contaminated drugs is criminal, and the government sees it that way. However, due diligence needs to be carried out to get to the root cause of the problem.
The license of the importer has been suspended. The two pharmacy outlets of the importer have been closed and the police have started the investigations in earnest. The Indian authorities have been contacted and on their own had taken steps against the manufacturer [which] includes closing the factory. It is already stated that the Indian authorities found a series of serious breaches at the factory.
Government is on the verge of setting up a commission of enquiry into the issue. This we believe will help in identifying the problems and coming up with recommendations to deal with the current problem and avert any future recurrences.
We appeal to all to support the government, our health experts and the partner experts working on establishing causality or causalities of death, to assist the police in their investigations and the commission of enquiry in the deliberation.
I thank you very much for your kind attention.