Counterfeit Botulinum Medical Products and the Risk of Bioterrorism

Abstract

Botulinum toxin has established a strong, worldwide position for the treatment of a wide range of clinical and aesthetic conditions. The products have brought considerable benefits to patients, from children with cerebral palsy to older patients with stroke-related conditions. Aesthetic use alone is probably over 10 million treatments per year and rising rapidly. The latest licensed applications in pain treatment and urology are amongst a range of new applications also under study. With this overall rise in clinical use, an increase in the availability of counterfeit and fake products has occurred. These products are readily available from Internet sources and may be purchased by doctors or patients. Their quality is, however, of considerable concern, in particular their content of excess amounts of active botulinum toxin in some cases and their lack of assurance of sterility for an injectable product. The potential for the sources of such products to become providers for bioterrorist activities is therefore of key importance. Can botulinum toxin from medical sources become a terrorist weapon? The background to this situation is discussed in detail, and the potential for such medical product use for bioterrorism acts is considered, using case studies.