malek Essay

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Krumholz, H., Hines,H., Ross, J., Presler, A., Egilman, D. (2007 January 20) What have we learned from Vioxx? BMJ, 334(7585). Retrieved November 11, 2013 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1779871/

In this article several professors talk about the Vioxx story. They talk about how data was falsified or not included to hide the cardiovascular effects of Vioxx. This article talks about how such a respected company such as Merck can still falsify clinical trials just to make money. This results in over 30,00 lawsuits for Merck to handle, but Merck still denies responsibility. In addition the financial incentives of everyone that conducted clinical trials and researched Vioxx was alarming. The authors of such publications should have no conflict of interest. There are also accounts of Merck employees emailing each other about the unfortunate data, and Merck writing sections of publications for which it was not listed as an author.

Lenzer, J., (2004 November 27) FDA is incapable of protecting the US "against another Vioxx" BMJ, 329(7477). Retrieved November 11, 2013 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC534432/

In this article the author details events in medical history, namely drugs that reached market, that caused deaths on a large scale. Each of these events resulted in major changes in the landscape of drugs that reach market to prevent similar events from happening again. The author then details why Vioxx was in fact the worst medical tragedy in US history and how we have done absolutely nothing to change or prevent VIoxx from happening again. The author wonders if we even learned our lesson.

Petryna, A., (2007) Clinical Trials Offshored: On Private Sector Science and Public Health. BioSocieties. Retrieved on November 11. 2013 from http://www.palgrave-journals.com/biosoc/journal/v2/n1/full/biosoc20073a.html

This article describes the shifting of clinical trials to oversees locations for FDA approval. This is mainly done by CROs because of cost. The problem with this is most studies done oversees are phase III trials that require a large heterogeneous population. If a clinical trial is done in Poland for example, the population may be large but it is not heterogenous, but instead biased for polish ancestry. This could mean the data generated is not representative of the US. The FDA currently accepts such data. At the time this article was written 40% of all clinical trials were done oversees, but the number has likely risen.

Pocock, S., Hughes, M., Lee, R., (1987 August 13) Statistical Problems in the Reporting of Clinical Trials. New England Journal of Medicine. Retrieved on November 12, 2013 from http://www.nejm.org/doi/full/10.1056/NEJM198708133170706

These authors show that statistical data in clinical trials is often misleading. The data is presented differently in each of the three clinical trials looked into in detail. This creates a sort of bias when trying to interpret the data. In simple terms the...

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