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 drug combined with other drugs are irrelevant. United
 States Vo Articles of D u ...Promi_ Tooth aste s 826 F.2d
 564; 570 (7th Cir. 1987)o Incomplete studies are
 insufficient. United States v° A__f Food & Dr_e
 supra. Uncontrolled studies are insufficient. 21 U.S.Co
 355(d); _q99_per Labs v. FDA, 501 E.2d 772p 778 (D.C. Cir.
 1974). Statistically insignificant studies are
 insufficient. 21 CFR 312.21, 314o50(d) (6) and
 314o126(b) (7). Poorly designed studies are insufficient.
 21 CFR 314.126(b) (2) o Poorly conducted studies are
 insufficient° 21 CFR Part 58 - Good Laboratory Practices.
 Poorly documented studies are insufficient° 21 CFR 312.58
 and 314o200(e) (4)° Studies by investigators who are not
 _aalified, both to conduct and to evaluate them, are
 insufficient° 21 U.S.C. 355(d)° Moreover_ since scientific
 reliability requires a double examination with similar
 results, one valid study is insufficient. There must be two
 or more valid studies which corroborate each other° See
 1 J. O_Reilley '_Food and Drug Administration '_ 13-55 n.12
 Lay testimonials_ impressions of physicians, isolated
 case studies, random clinical experience, reports so lacking
 in details they cannot be scientifically evaluated_ and all
 other forms of anecdotal proof are entirely irrelevant.
 21 CFR 314.126(e); Weinbe_er v. H_ns_on Etc., 412 U.S. 609,
 630 (1973) o

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