The Diethylene Glycol Case and Countries That Never Learn

The mysterious causes of acute kidney failure in children in Indonesia have been revealed. The presence of three chemicals found in the syrup, namely ethylene glycol, diethylene glycol, and ethylene glycol butyl ether, has been identified as the source of the problem by the Indonesian Ministry of Health. If these three chemicals are absorbed into the body, they will cause nervous system and kidney problems. There are 251 cases with a mortality rate of 56 percent, or 143 cases until October 26, 2022.

The incident of drug poisoning caused by these chemicals is not the first and has occurred frequently around the world. Unfortunately, we never seem to learn because all drug poisoning stems from the same error.

The Rise of Synthetic Drugs

The emergence of drugs roughly parallels the emergence of disease. Initially, humans used natural materials found in their surroundings to treat diseases, which became known as herbal medicine. As Keith Veronese points out in Making Medicine: Surprising Stories from the History of Drug Discovery, the trick at the time was trial and error. They took plant or animal parts, mixed them together, and drank them. If successful, this treatment would be passed down from generation to generation, from one generation to the next.

This process has occurred throughout history, from prehistoric times to the present. However, a watershed moment in the history of herbal medicine occurred in the nineteenth century, with the discovery of synthetic drugs, or drugs chemically processed by humans in the laboratory. The development of an understanding of organic chemistry was the primary driver of this change.

Scientists at the time knew the cause of herbal medicine efficacy, namely the presence of chemical compounds, thanks to organic chemistry. This sparked the desire to create their own drugs based on these chemical compounds.

To cut a long story short, scientists synthesized drugs from various compounds throughout the nineteenth century. Initially, they created drugs from natural ingredients that had been chemically altered in the laboratory. However, they advanced their own chemical compounds without stealing them from nature. There was large-scale drug production here. According to Walter Sneader in Drug Discovery: A History, synthetic drug therapy has since become the primary way to help sick people.

However, as the number of drug users grew, scientists failed to expect the excessive dangers of synthetic drug research and production. In connection with this, a shocking event occurred in the United States in 1937.

The Start of a Disaster

The plot started in 1932. Gerhard Domagk, a German doctor working for Bayer, was conducting antibacterial testing on mice. Domagk was successful in developing a drug that eliminated all bacteria in mice during that trial.

Prontosil was given the drug, which was later identified as an antibiotic. The discovery of prontosil clearly gave hope to the medical world because it could be an alternative to penicillin, the first antibiotic discovered.

To make a long story short, Domagk's findings were investigated further by a French research team. According to the findings, prontosil had a derivative as sulfanilamide, which had been effective in treating streptococcal bacterial infections that caused nervous, respiratory, and excretory disorders in humans.

In early 1937, one of the pharmaceutical companies, the S. E. Massengill Company, produced drugs in tablet and powder form for commercial purposes. The drugs sold well. As demand for sulfanilamide grew, customers requested that the drug be made available in liquid form. The tablet and powder forms were too difficult to take, particularly for children.

Unfortunately, this was a hard request to fulfill because sulfanilamide was chemically insoluble in water. However, this problem was solved when chemist Harold Watkins discovered a suitable mixture, namely diethylene glycol (DEG).

DEG was known at the time as a hazardous substance used to moisten solvents and explosives. Watkins missed it because he was already in a state of euphoria. Watkins believed that if this product was sold, it would do well. The DEG in the concoction had a sweet taste and an appealing aroma, and was slightly sour because of the addition of raspberry liquid, making it appealing to children.

And indeed, when the product known as Elixir Sulfanilamide was released, it quickly became the product of choice. Following that, the manufacturer produced 240 gallons of liquid medicine and distributed hundreds of thousands of bottles to all pharmacies in the United States.

However, the manufacture and distribution of the Elixir Sulfanilamide soon became the start of one of the pharmaceutical industry's darkest chapters.

Deceptive Sweetness

The American Medical Association reported an increase in patients across hospitals between September and October 1937. Hundreds of patients were on the list. They arrived with similar symptoms: nausea, vomiting, and abdominal pain, followed by kidney failure. It was unknown whether the infection was caused by a virus or bacteria. What was certain was that they died one by one after the seventh day of the initial symptoms.

Following an investigation, the red thread, Elixir Sulfanilamide, was discovered. All the patients testified they became ill after drinking 1-2 teaspoons of syrup. The manufacturer then issued the drug’s sales halt instructions. A wave of fear swept across the country.

According to American Medical Association research, the DEG content in a bottle of Elixir Sulfanilamide was excessive. This was discovered only after the fatal incident. There were 10 percent sulfanilamide, 15 percent water, and 72 percent DEG in a bottle of medicine. This was significantly higher than the normal limit of around 3 percent. The high percentage clearly leads to a high fatality rate. There were 248 victims, 105 of whom died, with 71 adults and 37 children among them.

Determining who was to blame for this incident was difficult. The proprietor of S. E. Massengill received only a $26,100 fine. It was difficult to determine who was to blame because there were no rules governing the maximum limit for dangerous substances in drugs. The pharmaceutical industry was not required to conduct toxicity tests under the applicable drug and food regulations. As a result, Watkins' action of mixing excess DEG fluid could not be held legally accountable.

This case was then used to evaluate whether the US government should pay more attention to the levels of chemical substances in drugs. Because of this tragedy, the Federal Food, Drug, and Cosmetic Act of 1938 tightened drug and food control. This regulation was later used to strengthen the Food and Drug Administration (FDA).

Similar Cases

There have been no further cases of DEG poisoning in the United States since then. All of this occurs because of the FDA's strict drug control. Cases like this, however, occur in other countries where there is a high reliance on chemical drugs.

Long before the cases in Indonesia and Gambia, the world had been shocked by cases of DEG drug contamination since the 1990s. The events in Haiti, India, and Panama can show why DEG is still present in pharmaceutical products.

In Haiti, health officials reported 109 cases of kidney failure in children between 1995 and 1996. This is because paracetamol syrup contained 24 percent DEG. Then, in 1998, there were 36 children with kidney failure in India, specifically in the Gurgaon district. The reason for this is that the cough syrup in circulation contained 17.5 percent DEG.

In Panama, the case was much larger. It was discovered that thousands of people, both adults and children, suffered from kidney failure, with 283 of them dying. The problem was caused by DEG contamination of cough syrup. Because of the magnitude of this figure, it is the largest DEG poisoning death case in history.

These cases have one thing in common: the manufacturers chose DEG as an alternative to using hazardous chemicals. This alternative step allows drug manufacturers to make the most profit with the least amount of capital. If you normally use glycerin as a thickener and sweetener, it will be replaced by DEG, which is much cheaper, in order to maximize profit.

However, the main issue is not only the producers' cunning but also the government's ineffective drug control function. With Panama, for example, the European company labeled the DEG brought from China with glycerin in order to deceive the relevant authorities.

Unfortunately, similar cases continue to occur because of a lack of supervision and strict regulations regarding the use of chemicals in the production of drugs. Then there's the case in Indonesia. The Indonesian Food and Drug Authority (BPOM) is unwilling to accept responsibility for cases of DEG and other chemical contamination in drugs. This attitude clearly contradicts the BPOM's task of overseeing all drugs and food in Indonesia.

Who should be held accountable if you are a victim?