Cacaito, I don't understand the points you are trying to make here in response to NeuroInvestment.
<<1. The Mayo clinic data is a case series, calling it "skewing" is not the answer, there are findings and an association wiht the use of the drugs, more studies are needed to clarify, but it is not good to start with.>>........The topic of skewing was in reference to the data from the 5 centers involving the 291 patients.....the Mayo clinic data involves the 24 pathologic valves from phen-fen users which first brought this possible relationship to the forefront.
<<2.Pulmonary hypertension (very similar mechanism to the valvular damage and sometimes a dual finding) was known in Europe and even the
probability (1 in 40,000)was given by an article favorable to Redux in
the NEJM where the authors try to say that the finding is similar in the obese population and should not be attributable to Redux.>>.........Pulmonary hypertension is a known, albeit rare, complication which has always been part of the profile of dexfenfluramine, I have not read where anyone is trying to dispute this.
<<3.Echocardiograms are heavily used now and not before, it could
explained the lack of the valvular findings in the past.>>.....Echocardiograms have easily been in "high" utilization for the time since Redux has been on the market, but beyond that.....a basic auscultation exam has been in existence well beyond the time the fluramines have been on any market.
<<4.Mitral valve prolapse(with or without regurgitation) is relatively
common, but not aortic regurgitation. Calling it an obese finding is not the answer, especially not good with the Jury (blame the victim).>>..........there was no calling this "an obese finding", just a postulation of what may be part of the new findings once a more decent study can be performed and evaluated.
<<6. The actual findings in the report on patients that were without
symptoms: out of 291 patients study, 92 had abnormal echocardiograms.
Numbers for Redux alone are indeed small 6 affected out of 20, only two in redux alone. ( my memory of 5% was below the actual 10 to 25%, of course this are small numbers, but good the frug is out before more
damage is done.) The companies retire the drug, they do know much better than what is out. Time will tell.>>..........The companies do not know "much better than what is out."......right now the only one holding information is the FDA, which could be helping lend a better handle on what we are dealing with.........but the companies withdrawal of the drugs was a prudent action based on potential problems based on the limited information dispensed, not because they knew something more than anyone..........this is what the AHP commissioned study will help decipher.
We are still trying to get basic information on the possible cause relationship of either/both of the fluramines in valvular hypertrophy, after that the real difficulty comes, if causality is established..... ........the question of negligence,......... now here is a "toughie." |
