Vivian Muoneke and Egbuna Olakunle Obidike 

2024 BLUEPRINT AFRICA

WHISTLEBLOWING PRIZE

Doctors averted the deaths of thousands of children worldwide by spotting that young patients were dying of kidney failure caused by toxic cough syrup.

In 2022 a worldwide toxic cough syrup scandal resulted in the fatal poisoning of more than 300 young children. It later emerged that the quick-thinking actions of a Nigerian paediatric nephrologist and her head of department at a training hospital in The Gambia may have averted a far deadlier global  crisis.

In 2021 veteran Nigerian paediatric expert Professor Egbuna Obidike was invited to The Gambia to set up a post-graduate training programme at the Edward Francis Small Teaching Hospital in the capital, Banjul. Among the medical consultants who joined him in 2022 was fellow Nigerian paediatrician Professor Vivian Muoneke, a kidney disease specialist.

The programme involved setting up the infrastructure and an administration that enabled the institution to be awarded accreditation for post-graduate training. Their programme, which effectively kicked off in 2022, emphasised practical training in clinical skills, an area Professor Obidike believes has been neglected over the years. Ten junior registrars were enrolled and assigned to work night  calls on the wards with patients from 4pm to 8am. They were supervised by two senior registrars, with 5 medical consultants on call at each point in time. This was followed by a morning report back meeting.

Obidike oversaw the department and Muoneke was in charge of patients admitted with kidney problems. The other consultants likewise attended to patients according to their specialties.

Muoneke became the first paediatric nephrologist to work in The Gambia. She described her resident doctors as “very sharp and intelligent”. They meticulously recorded the clinical history of these admitted patients, and Muoneke would analyse the results with them to arrive at a diagnosis, especially for those with kidney related diseases.

In June 2022, she and her team successfully performed renal replacement therapy on a patient with acute kidney injury (AKI) that was not drug related – the first time this procedure, known as peritoneal dialysis, had ever been done in The Gambia.

The following month a 46-month-old boy was admitted with AKI. He had a history of fever and cough, and been treated with oral medication. Two days later he stopped urinating, and was referred  to Edward Francis Small Teaching Hospital, where the paediatric nephrologist was based.

This time the child did not respond to treatment. “I had never had a case when a patient with AKI was not responding to peritoneal dialysis, so this was very strange to me,” says Muoneke.  

While managing this case, more patients came in with the same symptoms and from the information  and history obtained by the resident doctors, it became clear that all had been given oral medication, and that they had also stopped urinating just before being hospitalised. Soon afterwards they lost consciousness and died, despite efforts to dialyse them.

Muoneke realised the common denominator was that all these patients had been given oral medication before they stopped urinating. She reported her concerns to Professor Obidike, who concurred with her assessment that the occurrence had to be reported to the Ministry of Health.

In the meantime, more patients kept being admitted with AKI and dying. Muoneke became frantic, calling her colleagues in the UK, US, South Africa and Nigeria. Initially many believed an infection might be the cause. But both Muoneke and Obidike were aware of two episodes in Nigeria, when patients had been poisoned by contaminated paracetamol syrup. She persuaded Obidike that the Gambian children may have undergone similar experiences with the cough syrup they had ingested.

Officials from the Ministry of Health immediately paid a site visit to the hospital following the alert they received from the paediatric nephrologist. Further meetings at the ministry followed and a task force was set up to investigate. It included representatives of international health bodies.

On the wards the cases continued to increase. Muoneke described the experience as psychological torture. “They all died – I could not eat, I could not sleep.”

Obidike and Muoneke now voiced their suspicions more strongly, arguing passionately that contaminated cough syrups could be behind the deaths. They urged for an immediate ban of the sale of all paediatric syrups until the cause of the AKI deaths could be established, but ran into opposition.

Some task force members, fearing public panic, wanted to wait for the results of the toxicology tests. But The Gambia has no laboratory testing facilities as such, and cough syrup samples syrup had to be sent abroad, first to Senegal, then Ghana and finally to Switzerland and France – a time consuming process.

In the meantime Muoneke persuaded two parents to consent to post mortems. This was no easy task in a predominantly Muslim country. But the results were invaluable: they suggested that the children had most likely died from chemical injuries to most of their internal organs – not from infection.

This renewed the determination by Muoneke and Obidike to persuade the government to impose a ban. Obidike attended a task force meeting where he used the statistics presented by Mueneke and the pathologist’s report to push for the role of the syrups to be taken seriously.

Their efforts paid off when a decision was taken at the next task force meeting to temporarily suspend the sale and distribution of all paediatric syrups until all the toxicology results came back. Within days the number of new cases dropped dramatically. “Just a few people came during that week because they were taking [the existing cough mixture] from their cabinets – it was already there,” says Muoneke. 

The toxicology results were finally received in late September. “They confirmed our worst fears,” she says. The syrups contained “two terrible contaminants that can cause death”. This led to an immediate ban and recall of the implicated cough syrups. By then over 70 children had lost their lives.

The laboratory tests found the samples were contaminated by ethylene glycol (EG) and diethylene glycol (DEG), sweet, colourless liquids used to make brake fluid and anti-freeze. Despite being deadly to humans if ingested, the liquid is sometimes used as substitute for key ingredients in cough syrup, reportedly because it costs less than half the price.

The tests also revealed that the samples of four cough syrups produced by Indian drugmaker Maiden Pharmaceuticals that were exported to The Gambia were contaminated, whereas samples of syrups made by other companies sold in The Gambia tested negative. Maiden has denied any wrongdoing.

Muoneke and her colleague’s quick-thinking action prevented a much larger loss of life, not only in Gambia but elsewhere in the world too, by raising global awareness about the dangers of contaminated cough syrups.

On 5 October 2022 the World Health Organisation issued a worldwide product alert for the contaminated Maiden cough syrups. Within days doctors in Indonesia invited Muoneke to a series of Zoom calls to discuss a worrying uptake in the number of children dying from acute kidney injury. She suggested their deaths could be linked to the paediatric syrups especially the cough syrups they had been taking.

“I told them: please go and look at the drug history of your patients. You could be facing the same problem as we are in The Gambia.”

According to Reuters, after initial reluctance by the Indonesian authorities, urine and blood samples were sent for testing and came back positive for DEG on 17 October. Toxicology tests revealed cough syrups made by three local pharmaceutical companies were contaminated, prompting a product recall the next day.

By then 206 AKI cases had been detected in Indonesia, later rising to 241. Although 133 children died in Indonesia, most of them younger than five, the country’s population is over 100 times that of The Gambia’s. Thousands more could have perished if Indonesia hadn’t followed Muoneke’s advice.

Toxic cough syrups were subsequently linked to deaths of children in Uzbekistan, Tajikistan and Cameroon, resulting in sales bans, recalls and criminal prosecutions.

Muoneke and Obidike both believe the trainee doctors, and the Gambian government, should also be given credit for averting many more deaths, in The Gambia and other countries.

“If the government hadn’t started the paediatric training programme, and if the trainee doctors hadn’t been so diligent, it would not have been discovered as easily and timeously as it was,” says Obidike. “Gambia protected their children and protected the world.”

The chief medical director of Edward Francis Small Teaching Hospital subsequently commended Muoneke for her “excellent work for our institution and the country at large” by playing the “lead role in solving the spate of acute kidney injury (AKI) in children with the associated deaths of some 70 Gambian children”, and by ensuring “appropriate interventions were marshalled”. 

As a result, her contract in the Gambia was extended for another year to allow her to complete her work. “It was important to remain there and ensure the problem was dealt with definitively,” she says.

The repercussions in India have so far been muted. 

After the news broke in The Gambia, the Indian government launched an investigation and ordered Maiden Pharmaceuticals to halt production at its factory. Two months later it was given a clean bill of health.

The BBC reported that in December 2022 India’s drugs controller general wrote to the WHO stating tests from a government laboratory “were found not to have been contaminated” by the deadly compounds. A government official said the WHO was “presumptuous” to blame Maiden’s cough syrup for the children’s deaths “without valid scientific reasons”.

But the following year Indian authorities launched an investigation into allegations that a pharmaceutical regulator was bribed to switch cough syrup samples. The investigation was concluded earlier this year but it is not clear what action, if any, was taken. The results have not been released publicly.

Meanwhile in The Gambia, families of the children who died are suing Maiden, a local pharmaceutical distributor and the government for damages.

Legal proceedings are ongoing.

Vivian Muoneke and Egbuna Olakunle Obidike share the Blueprint Africa Whistleblowing Prize for 2024.

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