Unheard Voice

Diethylene glycol (DEG) is a sweetner and a solvent which has been involved in numerous cases of poisonings, both by accidental and deliberate introduction of the compound into medicines, food products and toothpaste. The earliest example of mass poisoning was the 1937 Elixir Sulfanilamide antibiotic incident in the USA. 107 people died after they ingested sulfanilamide dissolved in diethylene glycol. This episode was the impetus for the Federal Food, Drug, and Cosmetic Act of 1938, which guides the global industry standard till today.

In Bangladesh context the reason for DEG poisoning is reckless profiteering and greed. When producing bulk paracetamol syrup, there is a need for a solvent that tastes good, is harmless and dissolves the active ingredient of paracetamol very well.  The recommended solvent to make paracetamol syrup is propylene Glycol which costs around Tk 1600 per unit while DEG costs only tk 200.00 per unit. When a pharmaceutical industry requires thousands of units of solvents each year, the cost saving ( tk 1400.00 per unit) becomes quite substantial.

In recent years, deaths from medicines adulterated with diethylene glycol have been reported from South Africa, India, Nigeria, Argentina, Haiti, and Panama. In Haiti in 1996, 85 children died due to glycerine contaminated with diethylene glycol in a paracetamol syrup produced by a Haitian company, which did not use standard quality assurance procedures to verify the purity of the glycerine. Haitian government, in close collaboration with US government, Center for Disease Control ( CDC) conducted a protracted but thorough investigation and identified the point of production chain where paracetamol syrup was contaminated by DEG and what was the source of thoe DEG. When Panama has a similar incidence with much smaller fatality, their health department immediately recalled all the consumer products, traced the source back to China and created huge global hue and cry to force Chinese government take stern punitive and regulatory steps.

But so far the worst DEG related calamity is reported from Bangladesh. This 1995 paper by M Hanif et el published in the prestigious British Medical Journal reports world’s worset DEG related epidemic.

As is it stated by this BMJ article,

From January 1990 to December 1992, a mean of 10 patients with unexplained renal failure were admitted monthly to the dialysis unit. Between August and October 1990, 25 children developed acute renal failure while undergoing treatment at Dhaka Shishu Hospital for other illnesses. All had received paracetamol elixir supplied by the hospital pharmacy. The brand of paracetamol used was later shown to contain diethylene glycol. The government of Bangladesh banned the sale of paracetamol elixirs in December 1992. In the 12 months after the ban, total admissions for renal failure declined by 53% (from 187 to 89 patients) and admissions for unexplained renal failure declined by 84% (from 162 to 26 patients). In the last six months of 1993 only one patient with unexplained renal failure was admitted.

BMJ continues the discussion …

This outbreak of fatal diethylene glycol poisoning is one of the largest reported. Fifty one patients who died in this outbreak were documented to have ingested a brand of paracetamol shown to contain diethylene glycol, and the actual number of deaths was undoubtedly
far greater. An additional 185 patients with unexplained renal failure died at Shishu Hospital
during the study period; 85% had ingested an unknown elixir for fever. Though in these patients the elixirs consumed could not be obtained from the patient’s families for identification and analysis, it is probable that many, if not most, were paracetamol elixirs containing diethylene glycol. Many children poisoned by diethylene glycol undoubtedly went to other medical facilities, died at home, or lived in rural areas, where the majority of Bangladesh’s 120 million people live and where the implicated brands of paracetamol were also sold.

The authors led by Professor Michael L Bennish of Geographic Medicine and infectious Diseases from Tufts University, Boston analyzes that,

That this outbreak of diethylene glycol poisoning occurred, and continued for at least 35 months, reflects the difficulties of monitoring the drug supply and of enforcing pharmaceutical legislation in a developing country such as Bangladesh. The Bangladesh Drug Administration has an annual budget of $250 000 and 134 staff members, of whom only 43 are assigned to inspection, licensing, and testing. These 43 people have responsibility for licensing and monitoring 208 pharmaceutical companies, 4625 licensed drug preparations, 1208 wholesale drug distributors, and 19873 licensed drug retailers.” The administration operates a drug testing laboratory, but maintaining quality control in the face of financial constraints, the limited supply of equipment and reagents, and political interference in staffing and functioning is difficult. Doctors at Dhaka Shishu Hospital notified the administration in November 1990 of their concerns about the paracetamol elixirs. Samples of nine brands of paracetamol (two of which were subsequently found to contain diethylene glycol) were submitted from Shishu Hospital to the Bangladesh Drug Administration for testing in 1991, 1992, and 1993. No report on testing of the samples was received. Additional samples were submitted to two private laboratories in Bangladesh, which were unable to identify diethylene glycol. Government intervention occurred only after a press conference in November 1992 by doctors from Shishu Hospital announcing the results of the toxicological findings of the Massachusetts laboratory. Efforts to monitor the drug supply for safety are complicated by the proliferation of manufacturers of paracetamol. More than 100 different manufacturers were licensed to produce and market paracetamol elixirs at the time of this outbreak. All seven of the eight manufacturers of brands of paracetamol found to contain diethylene glycol were small companies with little capacity for quality control which, together with 180 other small manufacturers, account for less than 10% of drug production in Bangladesh.

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While one such incidence made the US government of 1937 revamp their Food and Drug Administration, enact a landmark act, when incidences with much less fatality makes governments of Haiti and Panama take extra ordinary measures of finding out the problem in the system and travelling as far as China to pursue the crime, Bangladesh government had finished their job by issuing banning of Paracetamol elixir/ syrup.

More than a decade after the publication of the above article, Bangladesh is now again startled at the discovery of continued serial killing of children in Bangladesh. Our governments, under media pressure and public outcry, successively have bothered to resort to short term damage control and hide the issue from public eye. There has not been an effort to enact new laws, impose robust regulation and quality control over mushrooming of pharmaceutical industries in Bangladesh. Our health ministers consider their only job is posting and transfer of their party cadres in more lucrative government hospitals.

Even while we are unearthing the impact of the serial killing of small unaccountable pharmaceutical industries, the government has washed their hand off the matter after forming a parliamentary investigative body. Interestingly and sadly the all powerful leader of this investigation committee himself is a Pharmaceutical industry man, former president of the association of the industry and currently the managing director of one of the largest pharmaceutical industries in Bangladesh. With the interests of Pharmaceutical industry protected, the hope of getting a fair judgment from this committee is bleak and lasting strict regulatory measures on pharmaceutical industries will remain unachieved. Hence we will let the serial killing of our children continue. As long as rural poor children, not the kids of us, the urban elites; are dying in throngs, we probably do not have to worry much about it. We have much more important things to think about than the heaps of dead bodies of poor children of rural Bangladesh.

Tags: Children, Healthcare

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