Complaint Counsel's Post Trial Brief - Federal Trade Commission

211. Universal Nutrtion has not conducted any testing on BioMixx. (R17 (Bauhoffer-Kinney,
Dep. at 50)).
F. Dr. Mier Conf"irms That There Is No Competent And Reliable Scientific Evidence
To Substantiate The Claims That DCO'S Products Treat. Cure. Or Prevent Cancer
212. Denis R. Miler, M.D. is a board-certified pediatrc hematologist/oncologist. Exper
Report of Dens R. Miler, M.D., dated Januar 28,2009, (hereinafter referred to as CX
52 at -- at 1.
213. For over 40 years, Dr. Miler has directed clinical care, education, laboratory and clincal
research, and adstration, heading divisions or deparents at University of Rochester
Medical Center, New York Hospital-Cornell Medical Center, Memorial Sloan Ketterg
Cancer Center, and Northwester University Medical SchooL. (CX 52 at 1).
214. Dr. Miler also has sered as Associate Medical Director of Cancer Treatment Centers of
Amerca ("CTCA") as well as Scientific Director ofCTCA's Cancer Treatment Research
Foundations. (CX 52 at 1).
215. As Scientific Director, Dr. Miler superised the clincal research program and was
pricipal investigator for a number of
Phase VII clincal studies involvig treatments for
hematological malignancies and cancers of the head and neck, lung, breast, pancreas, and
colon. (CX 52 at 1-2).
216. Dr. Miler has authored or co-authored over 300 book chapters, peer-reviewed aricles,
and abstracts, and has sered on the editorial boards ofthe British Joural of Hematology
and the Amercan Joural of
Clincal Oncology. (CX 52 at 3.)
217. Dr. Miler curently is the Oncology/Hematology Therapeutic Area Leader at P ARXEL
Interational, a leading contract research organzation, where he manages clincal trals
for the pharaceutical industr. (CX 52 at 2).
218. To constitute competent and reliable scientific evidence, a product that purorts to treat,
cure, or prevent cancer must have its effcacy and safety demonstrated though controlled
clinical studies. (CX 52 at 7).
219. Only data from well-designed, controlled, clinical trals will substantiate clais that a
new therapy is safe and effective to treat, cure, or prevent cancer. (CX 52 at 30).
220. Anecdotal reports of product effcacy are the weakest form of evidence supporting the
anticancer activity of a new agent. (CX 52 at 12).
221. Testimonials do not substitute for a well-designed clinical tral in proving the effcacy of
a supposed cancer fighting product. (CX 52 at 30).
222. Dr. Miler's thorough review of peer-reviewed literatue and all of the documents
produced by DCO indicates that there is no competent and reliable scientific evidence
that the DCO Products are effective either alone or in combination with other DCO
22