Beavis: Nice job Butthead on doing the statistical tables on the rat tumor data in the FDA briefing documents for the lorcaserin review panel. That was a stroke of genius to combine the benign mammary tumors with the malignant mammary tumors even though there is no connection between the two other than they both appear in the same anatomical location
Butthead: Thanks Beav. I thought you’d like that. Nothing like the specter of breast cancer to get the panel members riled up. Not to mention the women’s support groups to who this information will be helpfully provided.
Beav: Stroke of genius. You’re not vying for my job are you?
BH: Just following your lead. I read your paragraph from the executive summary on the rat tumor data; you sure you’re okay with that? There are three statements there that aren’t even supported by my combinatorial analyses.
Beav: C’mon Butthead, you’re not getting cold feet on me are you? Which statements are you referring to?
BH: First one says “An excess number of malignant mammary tumors developed in female rats treated with lorcaserin at doses within 7-fold of the proposed clinical dose of 10 mg BID” but the results at that level were clearly nonsignificant.
Beav: I didn’t say anything about significance did I? I just said excess number, and technically there were a handful of extra adenocarcinomas in this group even if it could have happened by chance. What else ya got?
BH: You also wrote “Male rats developed malignant mammary tumors when treated with lorcaserin at doses 17-fold higher than the proposed clinical dose” but there were only two tumors in this group and this in no way approached statistical significance.
Beav: C’mon Butt – I just said “male rats developed” which again is technically true; nobody is going to question whether my summary statements are backed up by statistically significant data. What’s the third concern?
BH: Well there is really only one other statement in the summary tumor paragraph and that one states “lorcaserin-treated rats had an excess number of malignant astrocytomas, squamous carcinomas of the subcutis, and malignant schwannomas.” However, the data for these three tumor types were only significant when the rats were given 55 times the human dose. Don’t you think we should at least acknowledge that and indicate that absolutely no such tumors were seen for all three of these tumor types at 5 times the human dose.
Beav: C’mon grasshopper, don’t get soft on me.
BH: But with all our degrees and years of experience, and fiduciary duty to the public, aren’t we suppose to have a handle on basic concepts like statistical significance and the inappropriateness of mixing apples with oranges?
Beav: Don’t worry about it.
BH: And you have no concerns about violation of 42 CFR 93 – Manipulating research materials, or changing or omitting data or results such that the research is not accurately represented in the research record.
Beav: C’mon now, what are the requirements for making such a determination?
BH: That (a) there be a significant departure from accepted practices of the relevant research community; and (b) the misconduct be committed intentionally, knowingly, or recklessly; and (c) the allegation be proven by a preponderance of the evidence.
Beav: Don’t be overly paranoid. You gonna back my play or not?
BH: Sure, you’re the boss. Remind me again why we hate lorcaserin so much even though it’s demonstrably safer than two other diet drugs that the panel reviewed in the last three months.
Beav: (raising right hand and rubbing thumb and forefinger together). Heh, heh, heh, heh.
(Repost from Yahoo MB, courtesy of CGBlood)
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