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FDA Reprimands Merck for the Release:

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.

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FDA Reprimands Merck for the Release:

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  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 Merck’s 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 Merck’s 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, there’s 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: “Conclusions—This 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: “Conclusions—This 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

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