Trust the Evidence | 12 Oct 2023
Commercial influences and deceit leading to the poisoning of children
You’ve probably all tried a cough syrup at some point; you may have given it to your children, but recently, global contamination has proven fatal. Cough syrup produced by one manufacturer, Digital Vision Pharma, has killed dozens of children in India.
Government analyses found the syrups contained the toxin diethylene glycol. However, India has recently found two more toxic syrups months after the poisoning deaths. The problem is also escalating globally, with spread to Indonesia, The Gambia and Uzbekistan.
Reuters report in ‘Uzbekistan, state prosecutors alleged distributors of a contaminated Indian cough syrup that killed 65 children in Uzbekistan paid local officials a bribe of $33,000 to skip mandatory testing.’ In Gambia, about 70 children under five died of acute kidney injuries after consuming cough syrups from an Indian company. In Indonesia, over 200 Indonesian children have died of acute kidney injury since 2022 from tainted cough syrup.
All of the deadly cough syrups contain the same poison – diethylene glycol (DEG) in a concentration far above safe levels. DEG is a sweet-tasting, colourless, odourless liquid commonly used in antifreeze, brake fluid, cigarettes, and some dyes. It was first identified in the 1930s, and problems with its toxicity were first reported in the USA when over 100 people died.
In 1937, diethylene glycol was used to dilute the formulation of a liquid preparation of the newly introduced sulfanilamide antibiotic. Under existing drug regulations, the drug known as Elixir Sulfanilamide did not require any premarketing toxicity testing. As a consequence of the tragedy, the US Congress passed the 1938 Federal Food, Drug and Cosmetic Act.
The new law made it mandatory to provide evidence of a drug’s safety before it could be marketed and also required the drugs to carry proper instructions for their safe usage. The Elixir Sulfanilamide scandal led to the establishment of the FDA’s authority in regulating drugs.
However, the sale and distribution of diethylene glycol continues to prove deadly – particularly for children. In Bangladesh, 339 children developed kidney failure after ingesting paracetamol syrup contaminated with DEG between 1990 and 1992 – most died. In 1996, almost 109 children were admitted to hospital in Haiti with acute kidney failure. Again, Paracetamol syrup contaminated with DEG was the cause – half of the deaths were under twos.
In 2008, a teething mixture containing DEG caused the death of at least 84 Nigerian children. DEG has also turned up in Beer: In 2019, in the Brazilian City of Belo Horizonte, 18 people were poisoned by one beer brand from a small local brewery – four died. DEG had been used as a coolant, but a leakage meant it turned up in the beer.
The reason why we keep finding DEG contamination is that it is less expensive than the safer diluents. DEG is highly toxic, and the use of safer alternatives is often overlooked in the manufacturing process because of the lower costs, the failure to adhere to standard quality control procedures during manufacturing and regulatory shortcomings.
The WHO is urging action to protect children from contaminated medicine. Especially important in this call for action is the need to check for signs of falsification and the physical condition of drugs by those who sell them, which is increasingly overlooked in the online world of pharmaceuticals.
Worryingly, India is the world’s largest provider of generic medicines, with a 20% share of global pharmaceutical exports. The Indian government has been forced into organising workshops for drugmakers to stress the importance of drug quality and patient safety. Yet, pharmaceutical executives and regulators told Reuters’ that it is common practice among some manufacturers in the country to substitute cheaper, commercial-grade ingredients when making cough syrups.’
Nearly ninety years after the first diethylene glycol scandal led to scores of deaths, we are again witnessing commercial influences and deceit leading to the poisoning of children that goes mostly unnoticed. It’s about time it was stopped.
