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Context of 'March 9, 2000: Merck Scientist Notes that Anticipated Heart Problems Among Vioxx Users Are a ‘Shame’'

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Merck official Briggs Morrison sends an e-mail warning that if the company conducts a proposed trial of the drug Vioxx (see also November 21, 1996), and the subjects do not take aspirin, there will be “more thrombotic events [i.e., more blood clots] and kill [the] drug.” In response, Merck scientist Alise Reicin laments that the company is in a “no-win situation.” She suggests that people with a high risk of cardiovascular problems be excluded from the study so the association between Vioxx and thrombotic events “would not be evident.” (Mathews and Martinez 11/1/2004)

Merck says it does not want to begin developing a plan to analyze the data on the large number of deaths from heart problems that has occurred during a clinical trial for its drug Vioxx (see December 22, 1999 and November 18, 1999). Michael Weinblatt, who is heading the study, sent a request to Merck the month before asking the company to develop such a plan (see December 22, 1999). Merck suggests that they wait and combine the cardiovascular results of this study with the results from other clinical studies for the drug. But Weinblatt is adamant that the company needs to begin analyzing the data immediately, and continues discussing the matter with Merck, which finally agrees to a plan the following month (see Early February 2000). (Prakash and Valentine 6/8/2006; National Public Radio 6/8/2006)

Edward Scolnick, head of Merck’s research labs, sends an e-mail to his colleagues noting that Vioxx’s anticipated cardiovascular side effects “are clearly there… It is a shame but it is a low incidence and it is mechanism based as we worried that it was.” (Mathews and Martinez 11/1/2004; Chustecka 11/1/2004)

According to an internal company document, Merck research chief Edward Scolnick discusses possible plans to reformulate Vioxx with the company’s in-house patent counsel. The new Vioxx would contain an anti-clotting agent to reduce the risk of cardiovascular problems. The document indicates that the company’s researchers believe the current Vioxx formula inhibits the production of a substance called prostacyclin which leads to blood vessel constriction and clotting. But Merck was alerted to this problem two years before by scientist Garrett FitzGerald, who had warned the company that all Cox-2 inhibitors would likely have this effect. Merck, eager to get its drug on the market, dismissed his research (see 1998). (Associated Press 6/22/2005)

Merck files a patent application with the US Patent Office for a drug that would contain a combination of Vioxx and an anti-clotting agent, or thromboxane inhibitor. The new drug would hopefully reduce the risk of cardiovascular problems while preserving Vioxx’s gastrointestinal benefits. Merck never develops the drug. Critics later note that Merck’s interest in this new drug contradicted its assertions that Vioxx was safe for the heart. (Associated Press 6/22/2005)

Fearing increased public concern over the safety of Vioxx, Merck sends its sales representatives a bulletin instructing them in all capital letters: “Do not initiate discussions on the FDA Arthritis Advisory Committee… or the results of the… VIGOR study.” The previous day, an FDA panel (see February 8, 2001) reviewed the results of the VIGOR study and said physicians need to be informed that Vioxx appears to cause “an excess of cardiovascular events in comparison to naproxen.” The Merck bulletin provides a list of responses that its representatives are authorized to use in addressing physicians’ concerns. It emphasizes that these are the only responses they are allowed to use. If doctors ask about Vioxx’s effects on the heart, sales persons should say, “Because the study is not in the label, I cannot discuss the study with you.” However, as a report by Henry A. Waxman notes, drug company representatives are permitted by FDA regulations to discuss safety concerns even when those concerns are not on the label. The sales persons are also advised to tell physicians to submit their questions in writing to Merck’s medical services department. Merck says reps can also show the physicians the Cardiovascular Card, a pamphlet consisting of data that appears to show that Vioxx is safe (see April 28, 2000). The bulletin indicates that sales reps are not supposed to leave the pamphlet with the doctor. (Merck 2/9/2001 pdf file; Office of Representative Henry A. Waxman 5/5/2005, pp. 22 pdf file)


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