Vioxx Clinical Studies - Vioxx Is Associated with an Increased Incidence of Heart Attack Myocardial Infarction, Stroke and Other Cardiovascular Problems. Sudden Death of Heart Cause, TIA, Blood Clots, Evidence Which Vioxx Lawyers Will Use to Establish Merck Liability.

Most important study in establishing the increased risk of heart attack in particular as well as stroke and other Vioxx adverse reactions, in these Vioxx attorneys view, is the August 2001 Cleveland Clinic Heart Center study. In these Vioxx lawyers estimation the study also supports the proposition that Merck culpably failed to earlier withdraw the drug and warn consumers in the face of the mounting evidence of the association of Vioxx with an increased incidence of heart attack in particular, stroke, and other adverse health consequences. .The Cleveland Clinic Heart Center study was published in the peer reviewed Journal of the American Medical Association in 2001, based upon data compiled in four previous clinical trials of Vioxx (and Celebrex, a similar drug) involving 18,064 patients. (Vioxx belongs to a category of COX-2 selective, nonsteroidal anti-inflammatory drug [NSAIDS]. Celebrex [celecoxib] is another COX-2 selective NSAID.)
Prior to the publication of the Cleveland study the data obtained in the March 2000 VIGOR (Vioxx Gastrointestinal Outcomes Research) study also found an increased risk of cardiovascular events in Vioxx users as compared the incidence of cardiovascular events for users of another pain drug. In Merck's VIGOR study, comparing Vioxx with naproxen, a highly statistically significant five-fold increase in heart attacks was demonstrated in the overall Vioxx group, 0.5 percent compared to 0.1 percent in the naproxen group. This amounted to 20 heart attacks in the Vioxx users (out of 4,047 patients) compared with four in the naproxen users (out of 4,029 patients). This increased number of heart attacks was also accompanied by an increase in other thrombotic (blood clotting) adverse effects such as strokes and blood clots in the legs as well as problems with hypertension in the rofecoxib group compared with the naproxen group.
In September 2001, the American Heart Association, the National Stroke Association and the Arthritis Foundation asked Merck to test whether Vioxx increased the risk of heart attack and stroke. In September, 2002, FDA sent Merck a warning letter asserting that the advertising for Vioxx was misleading. The warning letter was sent to Merck President and CEO Raymond V. Gilmartin, stating:
"You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen)."
Merke subsequently changed its advertising to list "heart attack" in the middle of a dozen infrequent Viroxx "side effects," however, without mention of the other adverse reactions including stroke, also found to be associated with Vioxx use in the VIGOR and Cleveland studies.
The Merck withdrawal of Vioxx, according to the company's press release, was based on adverse data from a recent placebo controlled efficacy study to determine whether VIOXX was efficacious in preventing the recurrence of colon polyps.. That study was stopped after the investigators determined that the data demonstrated that human subjects taking VIOXX had an increased risk for confirmed cardiovascular events, including heart attack and stroke over those who were receiving the placebo.
In these Vioxx attorneys view, the Vioxx clinical studies are important evidence to demonstrate that Vioxx users who suffered heart attacks in particular, as well as stroke and the other adverse reactions associated with Vioxx use, may have viable causes of action against Merck and Company. In addition, the evidence suggests that Merck may have deliberately turned a blind eye to the mounting evidence of Vioxx adverse reaction data, failing to respond to the pleas of the American Heart Association and Arthritis Foundation, and falsely advertised Vioxx, as implied also by the FDA warning letter.