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Lethal Cough Syrup

Responding to international anger, Chinese manufacturers and government officials have reluctantly acknowledged the substitution of glycerin's toxic cousin in toothpaste and cough syrup.
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"But to realize that six human beings, all of them my patients, one of them my best friend, are dead because they took medicine that I prescribed for them innocently..." So, the doctor wrote to the U.S. Food and Drug Administration, in a letter overflowing with guilt.

But the doctor's only sin was unknowingly distributing a cough syrup containing diethylene glycol, a lethal chemical cousin of the harmlessly sweet liquid glycerin. In the past few months, similarly poisoned cough syrup has been blamed on more than 50 deaths in Panama . Meanwhile, toothpaste laced with diethylene glycol has been seized in countries around the world, ranging from the United States, to Australia, Nicaragua and, mostly recently, Vietnam.

The toothpaste and the cough syrup were produced in China and sent around the world. Responding to international anger, Chinese manufacturers and government officials have reluctantly acknowledged the substitution of glycerin's toxic cousin in those products. The reason for the switch won't surprise you. Glycerin costs at least three times as much to produce as diethylene glycol, which best known as a component of industrial products like antifreeze.

It's a little more surprising to realize what dumb decision this is, if one actually wants to get away with a cheap substitute. Diethylene glycol is famously easy to detect, in and out of the body. Homicidal killers occasionally use it to lace food -- earlier this year a Georgia woman was convicted of killing both husband and boyfriend with antifreeze -- but any competent pathologist can figure that out. The poison leaves behind a distinct signature. It kills primarily by destroying the kidneys, jamming the organs with weirdly angular crystals, a clue as unmistakable as a bloody fingerprint.

A better knowledge of chemistry and pathology by the Chinese could have saved a lot of lives. And so obviously could a strong and ethical regulatory system. But they didn't have to make their own mistakes to learn that. They needed only a better knowledge of American history. The doctor's letter that I quoted was written not from Panama but from Louisiana, not in this year but in 1937, in the midst of a poisoned cough syrup debacle that killed more than 100 people in the United States and prompted legislation to newly empower the U.S. Food and Drug Administration.

At the time, the U.S. did not require toxicity testing of food and drugs, relying instead on the free market to control dangerous substances. But in the summer of 1937, a Tennessee company developed a new liquid cough syrup, containing a sulpha drug, raspberry flavor, and diethylene glycol. The cough syrup was sent out in September. The American Medical Association reported the first deaths in October, rapidly identified the compound, and alerted the company. The company responded by asking physicians to return the syrup, but failed to notify them that it was poisonous, and deaths continued to mount.

The FDA was created, with limited powers, in 1906 and was little changed in the 1930s. As a consequence, the only charge it could bring against the company was misbranding the cough syrup as an elixir, which by definition should have included alcohol. Still the agency persuaded the company to issue a stronger recall and then sent almost its entire field force of 239 inspectors to track down the lethal cough syrup. Many perceived it as unprecedented government interference; one cough syrup salesman went to jail before he would turn over his distribution list. The head of the manufacturing firm -- sounding remarkably like some of the Chinese manufacturers of today -- declared that his company had made no manufacturing error and "I do not feel there was any responsibility on our part." It's not clear if his attitude ever changed but the U.S. government's did -- the following year, the 1938 Federal Food, Drug and Cosmetic Act gave the FDA full power to regulate the introduction of new drugs.

Is there a modern lesson in this for us as well as for others? The obvious one is to deal warily with countries still using a pre-1937 standard of regulation. But we can also avoid making our mistakes twice. Although our current federal government favors an anti-regulatory position, and has repeatedly restricted FDA oversight rather than encouraging it, we should remember that these agencies and laws were empowered to save lives -- and when given proper support they
do just that.