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.” Merck’s Press Release after VIGOR: “Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx.” 2001

2. 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

3. 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.” 20002001

4. 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.” 20002001

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.” What Merck published in Circulation: “Conclusions—This analysis provides no evidence for an excess of CV events for rofecoxib” June 2001Oct. 2001

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.” Merck published: “Conclusions—This analysis provides no evidence for an excess of CV events for rofecoxib” June 2001Oct. 2001

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.” Merck published: “Conclusions—This analysis provides no evidence for an excess of CV events for rofecoxib” June 2001Oct. 2001

10. What Merck Knew about ADVANTAGE: VIOXX – 8 Heart Attacks/Cardiac Death Naproxen – 1 Heart Attack Statistically Significant - YES Merck published: “The rofecoxib and naproxen groups did not differ significantly in the number of thrombotic cardiovascular events…” 20012003

11. What Merck Knew about ADVANTAGE: VIOXX – 8 Heart Attacks/Cardiac Death Naproxen – 1 Heart Attack Statistically Significant - YES Merck published: VIOXX – 5 Heart Attacks/Cardiac Death Naproxen – 1 Heart Attack Statistically Significant - NO 20012003