Smoking Gun Documents: Vioxx Dangers
Researchers Warn of Alarming Side Effects
- November 1996: Merck researcher advises that allowing Vioxx study participants to continue taking low-dose aspirin would increase intestinal bleeding.
- February 1997: Merck executive Dr. Alise S. Reicin calls the use of low dose aspirin together with Vioxx "a no win situation."
- March 2000: A globally respected specialist tells Merck its argument for Vioxx' safety is probably not correct.
- March 2000: A Merck researcher notes that study results show "the CV (cardiovascular) events are clearly there.''
- November 2000: A study published in the New England Journal of Medicine finds that Vioxx causes much less stomach bleeding than naproxen but also notes a higher rate of heart attacks.
Manufacturer Ignores FDA Criticism
- May 2001: Despite the FDA warning, Merck touts the "favorable cardiovascular profile of Vioxx'' in a press release issued through PR Newswire.
Deceptive "Promotional" Tactics Encouraged
- September 2001: When Merck field representatives reported doctors were concerned about Vioxx side effects, the company prepared a list of disarming answers to the questions doctors asked most frequently. It was called "Vioxx dodge ball." CLICK HERE to view a color re-creation based on the original black-and-white document.
- September 2001: An FDA letter warns that Merck had "engaged in a promotional campaign that minimizes the potentially serious cardiovascular findings.''
- October 2001: A study in the medical journal Circulation concluded naproxen had a protective effect, like aspirin, that accounted for the higher rate of heart attack among Vioxx users seen in clinical trials. Merck relied on this rationale until it recalled Vioxx three years later, although it had known for years the theory was likely false.
Tens of Thousands of Deaths Potentially Associated with Vioxx
- November 2004: An editorial in the British medical journal Lancet says Vioxx revealed "astonishing failures'' by Merck and "lethal weaknesses'' at FDA.
- November 2004: Dr. David Graham of the FDA testifies to the Senate Finance Committee that Vioxx is associated with up to 139,000 "excess'' heart attacks, of which 30 percent to 40 percent were fatal.