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.”

Merck’s Press Release after VIGOR:“Merck Confirms Favorable Cardiovascular

Safety Profile of Vioxx.”

2001 2001

FDA says:“…your claim in the press release that Vioxx

has a ‘favorable cardiovascular profile,’ is simply incomprehensible…”

Merck’s Press Release after VIGOR:“Merck Confirms Favorable Cardiovascular

Safety Profile of Vioxx.”

2001 2001

What Merck Knew:The rate of cardiovascular experiences in VIGOR was 14.6% in the VIOXX group

What Merck said in a letter to doctors:“the rate of cardiovascular events was 0.5

among patients taking VIOXX.”

2000 2001

What the FDA said to Merck:“Your claim… is again inaccurate.”

Merck told doctors at an audioconference:“Now if you look at the remaining part of VIGOR, which is 96 % of the VIGOR population, there’s

no statistically significant difference in the MI [heart attack] rate between Naprosyn and Vioxx.”

2000 2001

Merck pooled data from multiple Vioxx trials and analyzed it for cardiovascular safety.

2000

Merck planned to publish their pooled analysis (meta-analysis), and they prepared

a manuscript for internal review.

2001

Briggs Morrison told his Merck coworkers their analysis “seems wishful thinking, not

a critical interpretation of the data.”

What Merck published in Circulation:“Conclusions—This analysis provides no evidence for an excess of CV events for

rofecoxib”

June 2001 Oct. 2001

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.”

Merck published:“Conclusions—This analysis provides no evidence for an excess of CV events for

rofecoxib”

June 2001 Oct. 2001

Briggs Morrison said:“the data appears to have been interpreted to support a preconceived hypothesis rather than critically reviewing the data to generate

hypotheses.”

Merck published:“Conclusions—This analysis provides no evidence for an excess of CV events for

rofecoxib”

June 2001 Oct. 2001

What Merck Knew about ADVANTAGE: VIOXX – 8 Heart Attacks/Cardiac Death

Naproxen – 1 Heart AttackStatistically Significant - YES

Merck published:“The rofecoxib and naproxen groups did not

differ significantly in the number of thrombotic cardiovascular events…”

2001 2003

What Merck Knew about ADVANTAGE: VIOXX – 8 Heart Attacks/Cardiac Death

Naproxen – 1 Heart AttackStatistically Significant - YES

Merck published: VIOXX – 5 Heart Attacks/Cardiac Death

Naproxen – 1 Heart Attack Statistically Significant - NO

2001 2003