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American Diplomacy
Commentary and Analysis

September 1998

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COMMENTARY

[Author David Work]

David Work is executive director of the North Carolina Board of Pharmacy.



 

POISON EXPORTS:
The U.S. has cast a blind eye to poison drug tragedies

By David R. Work

“It’s an international scandal that, over fifty years later, dealers in these poisonous pharmaceuticals elude justice. These dealers can expect a reserved seat in hell, but we need a secular way to deter others from such conduct in the future.”

Our society is bipolar when it comes to drugs.

We expect miracles from drugs to manage mental illness, cure some forms of cancer, and make organ transplants possible. At the same time we condemn illicit drug use, and federal authorities are ascending to apoplexy over referenda in Arizona and California which loosened controls on marijuana and other drugs.

Each is understandable in its own context: It’s natural to seek miracle cures, and drug abusers, at least at the beginning of their journeys, consciously choose their own course which is abhorred by so many in our population.

Yet we seem to have a blind spot to tragedies inflicted on innocent people outside our borders caused by contaminated pharmaceuticals. [In 1996] at least eighty-nine children died in Haiti from acetaminophen (paracetamol) syrup adulterated with diethylene glycol (DEG). Acetaminophen is the generic name for the active ingredient in Tylenol and it is virtually the only treatment for pain or fever in children.

This is just the latest in a series of pediatric ward catastrophes. In 1990, a Nigerian hospital reported that forty-seven children died at their facility from the same DEG-tainted acetaminophen product. More than 200 children died under similar circumstances from DEG in Bangladesh in 1992. All these cases involved pharmaceuticals in international commerce, and there is no record of any criminal prosecutions for this pediacide.

The scope of the Haiti tragedy can be appreciated by projecting it to the population of the United States. If that had occurred here, more than 3,700 children would have died, and the media uproar would certainly have produced prosecutions.

This contamination problem is well known in the pharmaceutical trade and is due to substandard glycerin, a commonly used sweetener. The first record of this as a problem was in 1937 when the Buffalo (New York) Pharmacal Company manufactured Elixir Sulfanilamide adulterated with DEG that caused over 100 deaths. DEG is the main component in antifreeze used to protect car engines and is highly toxic to humans. It was the first event of its kind and propelled the enactment of the Food, Drug and Cosmetic Act of 1938, which is the foundation for most current activities of the Food and Drug Administration (FDA). We owe our safe drug system to the practices applied by FDA and the standard established independently by the United States Pharmacopoeia.

It’s an international scandal that, over fifty years later, dealers in these poisonous pharmaceuticals elude justice. These dealers can expect a reserved seat in hell, but we need a secular way to deter others from such conduct in the future.

Safe drugs are, or ought to be, a basic human right. This is not a new concept when a Roman court during the reign of Caesar declared that the safety of the people shall be the highest law.

One way to address this problem is a United Nations convention to reach across national borders. It should provide a system of practices and standards for pharmaceutical manufacturers and ingredient suppliers in international commerce. Events producing death or serious permanent injury could be investigated by World Health Organization staff for potential criminal prosecution in the International Court of Justice in The Hague. This would put those in this business on notice that future malfeasance could cost them dearly. Lives would be saved and it would work to preserve the basic standard of safe pharmaceuticals for everyone in the world, including those most vulnerable.




This article appeared originally in the Feb. 7, 1997, issue of the Chapel Hill (NC) Herald. Reprinted by permission of the author.


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