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Prepared Witness Testimony The House Committee on Energy and Commerce
Issues Relating to Ephedra-containing Dietary Supplements.
Subcommittee on Oversight and Investigations
Mr. Kelly Conklin
My name is Kelly Conklin, I am a consultant to Cytodyne LLC and, until very recently, I worked for Cytodyne Technologies, Inc., which is now known as Nutraquest, Inc. (Cytodyne LLC recently acquired the rights to market Cytodyne Technologies' products, except Xenadrine RFA-1®, the ephedra-based dietary supplement, which was discontinued as of February this year.) Although we did not have very formal titles, I served as the Director of Public and Customer Relations for Cytodyne Technologies, Inc. I began working part-time for Cytodyne Technologies in 1997, while I was still employed as a Police Officer for the Dover Township, New Jersey, Police Department. I graduated from the New Jersey State Police Academy first in my class in the academic and physical components. While I worked at Cytodyne Technologies, one of my responsibilities was to deal with customers who contacted us with concerns about possible adverse effects that they experienced while taking Xenadrine RFA-1®. Beginning sometime in early 2000, Cytodyne Technologies received such complaints and Mr. Chinery, the owner of Cytodyne Technologies, asked me to take responsibility for handling the complaints. We received very few complaints initially. When, in June 2000, we received our first complaint of a potentially serious adverse effect, Mr. Chinery arranged for us to be able to refer such customers to Dr. Carlon Colker, and for Dr. Colker to review that complaint and provide us with any guidance or information that we needed. We tried to continue to improve over time the way we took information from callers. Many consumer calls or correspondence were not specific enough for us to determine whether Xenadrine RFA-1® was even used, to document the effect reported, or to ascertain information about other possible causes. Sometimes, the consumer indicated improper use of the product, pre-existing conditions that they thought might account for the reported event, or other information indicating that the connection to Xenadrine RFA-1® was missing. Since we at Cytodyne Technologies were not medically trained, however, we engaged Dr. Carlon Colker to help us understand and deal with customer complaints of alleged adverse effects. By engaging a medical doctor to guide us in this regard, we felt we were being very responsible. In addition, Dr. Colker provided responses for Cytodyne Technologies concerning adverse event report forms forwarded to Cytodyne Technologies by the Food and Drug Administration. According to our records, the Company has received complaints of adverse effects from the use of Xenadrine RFA-1® over a several year period during which approximately 20 million bottles of the product were sold, each containing 120 capsules, for a total of about 1.2 billion servings. After an extensive review by the Company and its attorneys, our records indicate a total of just under 450 customers contacted Cytodyne Technologies concerning their complaints about the use of Xenadrine RFA-1®, and most of those were for mild, transitory effects. It was our policy and practice to advise customers that if they were experiencing adverse effects, they should discontinue the use of the product, and contact their physician. We made Dr. Colker available to them to learn more about their situation and perhaps share some information with them concerning Xenadrine RFA-1®. Dr. Colker also advised us of the inherently unreliable nature of adverse event reports and customer complaints, and that many scientific studies showed ephedra-based dietary supplements to be effective and safe within the confines of the clinical studies and when used appropriately. Nevertheless, we paid attention to the information reported to him and reported from him to us, which we have of course turned over to the Committee in full. I am prepared to try to answer any questions and appreciate the opportunity to provide this information to Congress and the American public.
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