Official at merck decided to not conduct a separate

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Official at merck decided to not conduct a separate study for the drug, but instead monitored clinical results that were already underway or planned for other purposes. Richard Kronmal’s study focuses on an internal company report in 2001 by Merck. The Merck staff describes two recently completed trials involving around a 1000 patients on the drug Vioxx, and roughly the same amount on a placebo drug. Out of the 1000 patients taking Vioxx, 34 died, compared to the placebo, where 12 died. When Merck submitted the results of the trials to the FDA, they analysed the data in a different way. Deaths that occured after the patients completed their Vioxx trials, were not included in the report. This action helped reduced the risks associated with the drug Vioxx. The modified studies still prompted the FDA to question whether the risk associated with the drug was enough to warrant another ongoing trial, but Merck replied that its wasn’t. The company described the increase in mortality as “small numeric differences most consistent with change fluctuations”
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7 The company also covered the deaths related to Vioxx by claiming that the deaths of the patients were caused by other accidents, infections and/or poisonings. Merck also did not publish the results or properly inform the FDA of a study that suggested that Vioxx was more dangerous than a rival drug. The documents contained descriptions of a study called Protocol 906, that compared the response of 450 arthritis patients to Vioxx and its rival drug Celebrex. The two drugs performed equally well, but the rate of side effect amongst Vioxx users was roughly twice that of Celebrex. The results to the above study were never published or disclosed to the FDA. David Egilman also included an email in his internal documents between two employees of Merck that included the following: “this is a very serious result and you will hardly be surprised by the idea of keeping this VERY TIGHT for the moment” The above email excerpt shows how employees of the company were fully aware of this situation but due to the pressure on the drug giant to increase their multi-billion revenue that can be earned from blockbuster drugs were willing to put the lives of millions at risk and change not disclose the details of clinical studies conducted by them concerning Vioxx. Timeline of Events: Aol Search Data Leak:
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8 August 4 th , 2006: Aol releases the search data via a compressed text files on one of its websites consisting of the search results of 657,000 Aol users over the span of 3 months. August 7 th , 2006: Aol pulled the file from public access, but not before it had been mirrored by various sites and bloggers. August 7 th -21 st , 2006: The media explored and covered the story, popularizing it by naming it the Aol Scandal. The New York Times took a step further and reached out to some of the users whose search results were publicized.
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  • Fall '19
  • Merck, AOL

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