Complaint Counsel's Post Trial Brief - Federal Trade Commission

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upon a reasonable basis that substantiated the claims at issue in the <strong>Complaint</strong>. CCPF ~ 186. Respondents' purorted substantiation is a far cr from "competent and reliable scientific evidence." Thus, Respondents did not possess a reasonable basis for their adverising representations and such representations are misleading. a. Respondents Never Conducted Any Tests or Studies on the DCO Products Respondents have failed to produce any competent and reliable scientific evidence to substantiate their clais that Bio*Shark, 7 Herb Formula, GDU, and/or BioMixx prevent, treat, or cure cancer or tuors. They have conducted no scientific testing on any of the DCO Products, and no person or entity, including Universal Nutrtion, has been involved in the scientific testing, research, substantiation, or clincal trals of the DCO Products. CCPF ii 187 90, 198,203,206-09,211. Furerore, Respondents have no documents relating to their policies, procedures, or requirements for evaluating or reviewing the safety, effcacy, or bioavailabilty for the DCO Products. CCPF ~ 191. Respondents did present a seres of aricles that they purortedly relied upon as substantiation for their claims. However, durg her testimony at tral, Patrcia Feijo was unable to identify with specificity which aricles she relied upon as substantiation for the specific claims that brought about the charges in ths case. CCPF ~ 197. Moreover, these aricles were not admtted by the Cour for the trth of the statements contained therein. See R9a - R9at; Tr. 601-610. b. Dr. Miler, an Expert Oncologist, Conf"irmed that No Competent and Reliable Scientic Evidence Exists with Regard to the DCO Products At tral, <strong>Complaint</strong> Counsel submitted the Exper Report and testimony of Denis R. Miler, M.D., a board-cerified pediatrc hematologist/oncologist, which confirmed that no 24
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 25
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UNITED STATES OF AMERICA BEFORE THE
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TABt
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TABLE OF CONTENTS i. Complaint Coun
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14. "The priciples of BioMolecular
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38. Respondents have generated appr
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Respondent DCO "is the ONLY nutrtio
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priced with most other brands but w
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Florida, which Respondent DCO owns.
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C. Respondents Claim That Their Pro
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and the tuor behind my hear has shr
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BioMixx TM. . . GDU Caps TM. . . (d
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east examnation by mamography. On 1
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185. The DCO radio program and the
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211. Universal Nutrtion has not con
Page 29 and 30: 233. Nevertheless, Dr. Miler cautio
Page 31 and 32: 262. When enterng in the MA an acti
Page 33 and 34: 292. Duke made no effort to see whe
Page 35 and 36: nutrtional supplements and botancal
Page 37 and 38: 352. LaMont acknowledged that there
Page 39 and 40: 383. Dews never has heard of James
Page 41 and 42: 412. Dews is not famliar with any s
Page 43 and 44: 442. There are no indications in Du
Page 45 and 46: 472. LaMont does not know whether B
Page 47 and 48: 114 F.T.C. at 322; Thompson Medical
Page 49 and 50: it was not blinded or placebo-contr
Page 51 and 52: Tech., Inc., 128 F.T.C. 299 (1999)
Page 53 and 54: In the Matter of ) ) DANIEL CHAER O
Page 55 and 56: a. The Adverisements in Question Ma
Page 57 and 58: In the Matter of ) ) DANIEL CHAER O
Page 59 and 60: CCPF ~ 16-18. In 2002, James Feijo
Page 61 and 62: the ter "BioMolecular Nutrtion" to
Page 63 and 64: 1. Claims That the DCO Products Are
Page 65 and 66: above the brain stem. . . has compl
Page 67 and 68: direct statements. Id. at 318 and 3
Page 69 and 70: 12-12A; CCPF ~ 35. Respondents make
Page 71 and 72: c. Respondents Represented that GDU
Page 73 and 74: CCPF ~ 140 (emphasis in bold added)
Page 75 and 76: consistent with the FTC's approach.
Page 77 and 78: not cure the fact that the claims a
Page 79: fudamental requirements for scienti
Page 83 and 84: humans with cancer. CCPF ~ 228. il.
Page 85 and 86: lines of evidence." CCPF ~ 280. LaM
Page 87 and 88: effectiveness ofGDU, BioMixx, Bio*S
Page 89 and 90: adverisements and promotional mater
Page 91 and 92: canot, however, make deceptive stat
Page 93 and 94: dosages ofthe DCO Products. CCPF ~~
Page 95 and 96: VI. CONCLUSION The evidence at tral
Page 97 and 98: In the Matter of DANIEL CHAPTER ONE
Page 99 and 100: CX 14 Attachment C to Administrativ
Page 101 and 102: CX33 Emails from DCO relating to FT
Page 103 and 104: 2. James Feijo Owner and President,
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Complaint Counsel's Post Trial Brief - Federal Trade Commission

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