These lawsuits are getting both tiresome and redundant in their wording (mainly just need to change the names of the law firms and the states involved), although it is also of interest as from the newswire report on today's filing..........
<< Plaintiffs allege that studies have shown that the drugs, particularly when used in combination, can lead to potentially life-threatening pulmonary hypertension and valvular heart disease. The lawsuits further allege that the pharmaceutical companies knew that the ''fen-phen'' combination had not been approved by the FDA and that both fen-phen and Redux had not been adequately tested, and were being routinely prescribed by physicians.>>
The initial studies have mainly involved "fen-phen" (the 24 Mayo clinic patients, and 271 of the 291 patients initially submitted to the FDA from the 5 centers), and the wording on this report goes into extra detail on the "evils" of the "fen-phen" combo.
Meanwhile, more interesting words from NeuroInvestment on the Motley Fool board............<<A couple of comments about the Reuters article:
1) Having spoken with Glenn Cooper on several occasions, I do not believe that he is accurately cited as saying Redux has 'little or no role in heart valve damage': he may have been pointing out that very few patients who had been assessed as having valvular damage had been on Redux alone (6 out of the 291 in the initial sample), but there is quite a bit of difference between those two issues. Neither Glenn Cooper, the FDA, Barron's, WSJ, or the
other myriad commentators weighing in on this issue (myself included) knows if Redux plays any kind of causal role in any type of valvular changes. Without a controlled study and clarification of how obesity itself affects the base rate of valvular pathology, we are all guessing. I have raised some issues based on the longitudinal evidence offered by the longterm European experience with Redux, but that only begs several questions, without
answering anything definitively.
2) It is unfortunate that the FDA, in its public pronouncements, has treated the information they have acquired thus far as if it is of higher calibre than it is. Come February or so, the highest quality controlled retrospective study, sponsored by Wyeth Ayerst but overseen by an independent Harvard Med cardiologist, will give us something far more informative than the muddled case studies offered thus far.
3) The fact that Dr. Bowen's 122 patients were apparently very skewed in their selection (that they had diagnosed heart murmurs), and yet the FDA states that the base rates of echocardiogram pathology were the same amongst their five diet centers, is somewhat suspicious in itself. If the other four had been semi-randomized, and Bowen's skewed, the rate of valvular changes might well be expected to be higher in Bowen's group. According to the
FDA, it was the same. This is almost too 'neat', too seemingly homogenous. Also, I have heard reports that the FDA's classification of some patients, in terms of who showed abnormalities, was different than that of the centers themselves (specifically, that the FDA classified some patients as abnormal, whose echocardiograms were not seen as abnormal by the diet centers). All this means is that we should be very cautious about assuming that we
know anything, the extant datasets are uncontrolled, and their interpretation suspect. NeuroInvestment>> |
