Complaint Counsel's Post Trial Brief - Federal Trade Commission

competent and reliable scientific evidence substantiates Respondents' claims concerg cancer.
CCPF ii 212,222. For over 40 years, Dr. Miler has directed clinical care, education, laboratory
and clinical research, and administration, heading divisions or deparents at University of
Rochester Medical Center, New York Hospital-Cornell Medical Center, Memorial Sloan
Ketterng Cancer Center, and Northwestern University Medical SchooL CCPF ~ 213. Dr. Miler
has superised numerous clinical studies of cancer treatments and authored hundreds of
chapters and peer reviewed aricles on cancer. CCPF ii 215-17.
book
Dr. Miler noted that "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 clincal studies." CCPF ~ 218. He stated that "only data from well-designed,
controlled, clinical trals wil substantiate claims that a new therapy . . . is safe and effective to
treat, cure, or prevent cancer." CCPF ~ 219. Dr. Miller also noted that anecdotal reports are "the
weakest form of evidence supporting the anticancer activity of a new agent," and that
testimonials "do not substitute for a well-designed clincal tral." CCPF ii 220-21.
Dr. Miler concluded that "(a) 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
products in the treatment or cure of cancer, in inbiting tuor formation, and in preventing the
destrctive effects of radiation and chemotherapy." CCPF ~ 222. None of
put forth by Respondents contradicted Dr. Miler's findings.
the purorted expers
I. Respondents' Claims that Bio*Shark Inhibits Tumor
Growth and Effectively Treats Cancer Are
Unsubstantiated
After reviewing the peer-reviewed literatue and all ofthe documents Respondents
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