There were a number of factual errors in the previous post:
1) The 'skewing' of the Bowen sample is pertinent in that the FDA, several writers, and litigation attorneys, have cited it as supporting the incidence of valvular abnormalities in the general population of fluramine users. If his population was preselected for heart murmurs, that throws off its applicability to prevalence estimates.
2) There had been no animal data giving "clues" re: valvular changes.
3) There has been no European data ("experience") indicative of valvular pathology over the decade plus of fluramine usage there.The questions raised by the absence of such pathology in such a large group (11 million Redux users alone) have been well-explicated in previous posts.
4) W-A and IPIC responded to the FDA 291 patient sample in pulling the drugs off market. They had not done any independent echocardiogram studies, and they did not cite any "5%" figure as pertaining to drug-related changes. They have noted that the incidence of valvular pathology in the general population, and particularly in obese population, may be higher than has been guesstimated by the FDA.
5) Since there was no similar 'problem' in Europe 10-15 years ago, the NEJM editorial did not cite a European history of valvular pathology. One should read such editorials a bit more carefully, or at least cite them more accurately.
6) The planned Phase IV study of neuropsychological functioning has been dropped. The new W-A study referred to is the 400/400/400 patient retrospective study of patients on fen-phen/Redux alone/on no drug, matched for obesity and perhaps some other comorbidity variables.
The conclusions drawn in the previous posting are predicated upon a series of ill-informed assumptions. One has the right to one's own opinions regarding liability, public opinion, and company prospects etc., but some modest interest in factual reality would be useful as well. NeuroInvestment |
