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There's no question that genetic engineering is a crucial
part of modern medicine and scientific research, but what happens when there is
an "oops" in the process?
And no, I don't mean this…

Image Source:
Flatrock.org
Genetic engineering, not to be confused with animal or plant
breeding, involves the direct modification or alteration of an organism's DNA.
It all started in 1972 when Paul Berg
formed the first recombinant DNA from the genes of two different organisms
(a monkey virus and a bacterial virus in case you were wondering). Since then,
genetic engineering has become an essential part in the production and
advancement of modern medicine and biological understanding, and also an
unending source of controversy and debate (but let's not go there…).
In this case, it goes without saying that technologies which
make the largest contributions to society also have the greatest consequences
when something goes wrong.
The Incident
L-Tryoptophan (pictured right), first discovered in 1901 by Sir Frederick
Hopkins, is a stereoisomer of the amino acid tryptophan, an important
supplement in the human diet incorporated in cell structure. In 1988, a
Japanese pharmaceutical company called Showa Denko produced the first batch of
genetically engineered L-Tryptophan to the U.S. The batch contained trace
levels of impure ingredients which caused consumers to contract a disease
called Eosinophilia Myalgia Syndrome. The sickness affected over 5,000
Americans, killing 37 and leaving many others permanently damaged.
The Cause
In federal court, Show Denko's attorney admitted that
genetic engineering was most likely the cause of the calamity. However, prior
to the trial the original batches of bacteria (where the amino-acid was
extracted) were destroyed (convenient, eh?). So, while Show Denko was clearly
at fault, the source of the error could not be traced definitively to the
genetic engineering, and the FDA later declared the fault to be an error in the
manufacturing process.
The Effect
As a result of the incident, the FDA and other regulatory
agencies in the U.S. placed a ban on the over-the-counter sale of L-tryptophan
which lasted 20 years.
Lessons Learned?
The mistakes of Showa Denko, which were never fully
uncovered, reveal the delicacies associated with pharmaceutical and medicinal
products. Quality assurance and sufficient testing are essential to
making a successful product. In the pharmaceutical industry, this "success" is largely a measure of the consumer's health.
There are countless numbers of drugs and dietary supplements
(like L-Tryptophan) on the market, all of them looking to become the big thing
in weight loss or fill-in-the-blank treatment. But this saturated market seems
incredibly intimidating, especially when even small manufacturing or
engineering mistakes could pose serious consequences to a person's health. Marketing
misinformation and exaggerated promises don't help anything either…
Has modern genetic engineering in the medical realm become
foolproof? I can't say. But you won't find me trying just any XYZ supplement until the bandwagon has long gone and come back again… healthy.
References:
Dark
Side of Genetic Engineering
Holland
& Barrett - L-Tryptophan Is Back
MSN
Health
Genome
News Network
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"Almost" Good Answers: