FDA%20Reprimands%20Merck%20for%20the%20Release:

1
FDA Reprimands Merck for the Release you fail
to disclose that your explanation is
hypothetical, has not been demonstrated by
substantial evidence, and that there is another
reasonable explanation, that Vioxx may have
pro-thrombotic properties.
2001
2001
Mercks Press Release after VIGOR Merck
Confirms Favorable Cardiovascular Safety Profile
of Vioxx.
2
FDA says your claim in the press release that
Vioxx has a favorable cardiovascular profile,
is simply incomprehensible
2001
2001
Mercks Press Release after VIGOR Merck
Confirms Favorable Cardiovascular Safety Profile
of Vioxx.
3
What Merck Knew The rate of cardiovascular
experiences in VIGOR was 14.6 in the VIOXX
group
2000
2001
What Merck said in a letter to doctors the
rate of cardiovascular events was 0.5 among
patients taking VIOXX.
4
What the FDA said to Merck Your claim is again
inaccurate.
2000
2001
Merck told doctors at an audioconference Now
if you look at the remaining part of VIGOR, which
is 96 of the VIGOR population, theres no
statistically significant difference in the MI
heart attack rate between Naprosyn and Vioxx.
5
Merck pooled data from multiple Vioxx trials and
analyzed it for cardiovascular safety.
2000
6
Merck planned to publish their pooled analysis
(meta-analysis), and they prepared a manuscript
for internal review.
2001
7
Briggs Morrison told his Merck coworkers their
analysis seems wishful thinking, not a critical
interpretation of the data.
June 2001
Oct. 2001
What Merck published in Circulation Conclusions
This analysis provides no evidence for an excess
of CV events for rofecoxib
8
Briggs Morrison said conclusions may be too
strong a word there is no evidence also seems
(to me) to be a bit of a stretch.
June 2001
Oct. 2001
Merck published ConclusionsThis analysis
provides no evidence for an excess of CV events
for rofecoxib
9
Briggs Morrison said the data appears to have
been interpreted to support a preconceived
hypothesis rather than critically reviewing the
data to generate hypotheses.
June 2001
Oct. 2001
Merck published ConclusionsThis analysis
provides no evidence for an excess of CV events
for rofecoxib
10
What Merck Knew about ADVANTAGE VIOXX 8
Heart Attacks/Cardiac Death Naproxen 1 Heart
Attack Statistically Significant - YES
2001
2003
Merck published The rofecoxib and naproxen
groups did not differ significantly in the number
of thrombotic cardiovascular events
11
What Merck Knew about ADVANTAGE VIOXX 8
Heart Attacks/Cardiac Death Naproxen 1 Heart
Attack Statistically Significant - YES
2001
2003
Merck published VIOXX 5 Heart
Attacks/Cardiac Death Naproxen 1 Heart Attack
Statistically Significant - NO