Screams from a Glass Coffin

Abstract

Thanksgiving Day at New Jersey Poison Information and Education System progressed as it had for many years before. Calls from frightened people when they realized they forgot to remove the bag of organs from inside the turkey before baking it. Others asked what temperature and for how long to cook the turkey. All in all things were pretty quiet. The next day was filled with the usual assortment of poison center calls punctuated by those people who thought they may have developed food poisoning from the meal. Although it is never really boring at the poison hotline, the work is often tedious. Things were about to change a bit for the medical director and staff of the poison center.

Postscript

The FDA’s Office of Criminal Investigation (OCI) launched an investigation into the situation. In total there were over 200 investigations of physicians throughout the United States. It is estimated that over a thousand individuals were injected with the preparation sold by Toxin Research International, labeled “For Research Only, Not for Human Use. The OCI investigation eventually led to 31 arrests and 29 convictions of individuals who purposely injected unlicensed botulinum toxin into individuals without the knowledge that they were receiving such an unlicensed product. Charges ranged from the use of an unlicensed preparation to conspiracy, mail fraud and misbranding of a drug to making false statements, etc. Toxin Research International and its owners, and the male patient in this outbreak were indicted in the United States District Court in the Southern District of Florida. The male patient in our outbreak was sentenced to three years in federal prison for his role in the administration of unapproved and dangerous toxin to humans.

According to a report in the Sun Sentinel, a Fort Lauderdale newspaper, in 2007 the Florida couple in the outbreak settled a civil lawsuit against the supplier of the toxin, List Laboratories. A confidentiality agreement was signed.

In a bit of tragic irony, on October 26, 2009, plaintiff Bach A. McComb filed a lawsuit against List Biological Laboratories in the Florida Southern district Court for personal injury. It appears that this suit ended when List Laboratories filed for bankruptcy.

List Laboratories still maintains a business of selling a variety of toxins, including botulinum (website active November 3, 2015). They do have an application which must be completed for new customers requiring a description of business or university department, and a “brief description of the research planned with List’s products.” They still offer a vial of 100 μg of botulinum neurotoxin Type A Complex from Clostridium botulinum for $260.00. They state that “All orders must be received by 12:00 pm PST to be eligible for same day shipping.” Their website claims:

List Labs complies with federal regulations covering the possession and handling of bacteria and toxins. We have designed a laboratory to provide the appropriate containment to protect both laboratory workers and the environment. Documented procedures and a well-developed training program support operations compliant with regulations.

List Labs is registered with the CDC Select Agents and Toxins Program for Tier 1 agents, and the staff is trained and experienced in BSL 3 large scale manufacturing. During more than thirty years of experience in working with toxins and bacteria, we have developed the necessary infrastructure to support manufacturing and shipping according to regulations. We can apply our knowledge to your project and help you develop an approach to compliance.