Here is the second and final part of the expert witness report filed by Lemuel A. Moye in Longs v. Wyeth.
United States District Court, N.D. Ohio.
Ramonia LONGS, et al.,
v.
WYETH, et al.
No. 103CV02042.
March 31, 2005.
101 Combined Endpoints in Khan: For Khan, mitral valvulopathy was just one
component of the combined endpoint for cardiac valvulopathy. It is no surprise
that the high odds ratio seen for the combined endpoint could not be reproduced
for mitral valvulopathy if the number of events was small. It would be
unreasonable to conclude that there is no relationship between anorexigen use and
mitral valvulopathy solely because a high odds ratio could not be reproduced for
this low prevalence component of the endpoint. In general, the practice is to
extend the findings for the combined endpoint to each of its components as long as
there is no discordance in the components (i.e. the OR for mitral valvulopathy
suggests a strong protective effect of anorexigens). If this device were not
admissible, it would be impossible to study links between exposure and diseases of
very low prevalence, since the large number of patients required for the studies
would preclude any meaningful analysis.102 The Epidemiological Study of Jick Jick[27] conducted a study, which confirmed
the findings of Khan, His confirmatory study was a population-based follow-up
study, which included a nested case-control analysis diet drug exposure, to
evaluate the relationship between fenfluramine exposure and the occurrence of
cardiac valvulopathy. In lick's study, out of 9,281 patients who were unexposed to
the fenfluramines, not a single patient had been diagnosed with cardiac valve
disease. Of the 8,903 patients who had been exposed to the fenfluramines, 11 had
cardiac valve disease (cumulative incidence rate 14.2 95% confidence interval 7.8
to 26.2). Some have somewhat naively criticized Jick for not reporting an odds
ratio for this overall effect However, they misunderstand that the odds ratio is
mathematically impossible to compute because no one in the unexposed group had the
disease. Cardiac valvulopathy only occurred for patients taking the fenfluramines.
Criticism of Jick for not computing an odds ratio in this circumstance is like
criticizing a baseball player for not stealing any bases when, in fact, that
player hits only home runs.