There are two issues raised by this latest WSJ report. One has to do with the prevalence of any valvular dysfunction amongst fluramine drug users (which in itself does not establish causality). This report included a grand total of 7 Redux users, four of whom used Redux alone. As the previous post noted, there has been heavy Redux usage in Europe over the past decade plus, estimates are that over 10-11 million people used Redux. Given the fact that over the past three months, it is certain that the press, liability attorneys, and health authorities have scrutinized all conceivable European databases for evidence of valvular pathology due to Redux or Pondimin, this Belgian report is paltry indeed. The questions regarding base rate and causality pertain here as they do in the US.
More important is the question of whether the case reports made 1994-6 constituted 'critical mass' for a red flag of concern, one that should have led to a response by AHP, IPIC, and/or the FDA. If so, and if there was any deliberate coverup, that would change the liability scenario drastically. Based on the information available thus far, I do not believe that this is the case, at least for Interneuron. Based on 11,000,000 putative users, reports of valvular pathology for four taking Redux, three taking Redux/Pondimin (and we do not know if any of them were also taking those Chinese herbs) would not necessarily seem to represent a significant incidence. They did report one case to the FDA, just as AHP reported 8-10, based on some criterion of severity. If they were trying to cover up, there would be no reason for them to report any of them. Drug companies receive reports of adverse events on a daily basis for drugs receiving widespread usage, and sorting out which ones represent a significant, meaningful pattern demanding a response, is hardly clearcut. The FDA received case reports and did not deem them significant... not even significant enough to present to its own Advisory Committee.
Now that this valvular pathology issue has hit the headlines, it is easy for hindsight to seem 20/20, for observers to claim that this miniscule incidence of ambiguous (in terms of severity, in terms of coincidental use of other problematic substances) case reports constituted a clearcut health risk situation that warranted some type of intervention. As has been the case all along, AHP may have more to worry about, it had a larger database of Belgian case reports to contend with for Pondimin. Unless there emerges a considerably larger body of Redux cases that can be documented as having been reported to IPIC and not reported farther (which I continue to doubt was the case), I believe that 'critical mass' for a substantive claim that there was an identifiable risk left unreported has not been reached.
Most probably there will be an intermittent series of 'me-too' announcements over the next few months, as various European observers claim that they too had noticed valvular problems. Keep an eye on the relative proportion of patients that appear involved: remember that if the FDA was right in its 30% estimate, we should have heard about 3.3 million cases by now......right now we are running 3,299,970 short.
NeuroInvestment |
