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On April
1, 2004, FDA discovered proof that counterfeit therapeutic agents were
being sold via email solicitation to the public and to communities of clinical
practitioners. Despite ingenious tactics intended to mislead potential
customers, investigatory insight led to regulatory action and criminal
proceedings.
Counterfeit "Zocour"
(photo credit, product origin)
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Actual Zocor®
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ZOCOUR was marketed via direct and
electronic mail to most of the American public during February and March
2004. Ostensibly a Newfoundland version of Zocor® (simvastatin)
a lipid-lowering agent, this product (see photo) was sold to thousands
of American coronary patients during the winter of 2003. The recognized
mis-spelling was apparently intentional, gaged to enhance the impression
that the medication was from a Canadian source, with a uniquely colourful
spelling.
Similarly, the package insert also simulated
Canadian custom, and presented a bilingual forgery, with the French "translation"
an apparent direct literal copy from the online BabelFish
resource:
ZOCOUR 1
(simvastatin) is a lipid-lowering agent that is derived synthetically from
a fermentation product of Aspergillus terreus . After oral ingestion, simvastatin,
which is an inactive lactone, is hydrolyzed to the corresponding (beta)-hydroxyacid
form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA)
reductase.
ZOCOUR 1 (simvastatin)
est un agent de réduction de lipides qui est dérivé
synthétiquement d'un produit de fermentation de terreus d'aspergille.
Après l'ingestion orale, le simvastatin, qui est une lactone inactive,
est hydrolysé à la correspondance (forme de beta)-hydroxyacid.
C'est un inhibiteur de réductase de 3-hydroxy-3-methylglutaryl-coenzyme
A (HMG-CoA).
Counterfeit "Aerisept"
(photo credit, product origin)
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Aricept® (donepezil)
10 mg
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AERISEPT was a similarly substituted
product, but presents much improved tablet similarity. Aricept®
is the most popular approved Alzheimers' therapy, and is prescribed to
a large, mostly elderly patient population. For this scam, the original
product selected for mimickry was particularly opportune, since patients
include those capable of having forgotten the physical format of their
usual therapy. Also, when the original wrapper was occasionally included
in the fraudulent product, this was considered proof of the agent's intended
treatment goal.
Other similar efforts to traffic in counterfeit
medications have also been cracked through careful forensic spell-checking.
Such close copy mimics have been sold through any of the following single-letter
substitutions:
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Erectile / Sexual Health
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V1agra (sildenafil)
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Ciali5 (tadalafil)
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Narcotics and drugs of abuse:
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Darv0n
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Sona
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Valivm
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Dilawdid
Several clinical therapies are still under
review and have prompted investigators to request submission of efficacy
data. Examples include:
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"Guaranteed Weight Loss Patch, Lose 10-12
lbs. In 30 days!"
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"HGH - More energy and permanent weight loss"
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"Male Growth Pills -- 100% Guaranteed!!!"
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