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From Center for Genetics and Society forum: http://www.geneticsandsociety.org/article.php?id=5838

Another upsetting story by Dan Walter shows that the failure lies not just in the FDA’s process, but also in medical conflicts of interest. Walter’s wife was enrolled in a study of Johnson & Johnson’s Biosense Webster Lasso Mapping Catheter, but a device error, combined with misuse from the cardiologist, left Walter’s wife at death’s door, necessitating immediate open heart surgery, after which she suffered a stroke and remained comatose for three weeks. The catheter had already proved substantial equivalency for the FDA and so the study, led by John Hopkins doctor Hugh G. Calkins – paid adviser to Johnson & Johnson – was solely intended to gather data, yet the IRB was not involved. Calkins admitted that the device was at fault, yet it remains on the market today.

Life Saving Devices May Put Your Life in Danger geneticsandsociety.org
Reports of conflict of interest in clinical drug trials, as well as unsafe drugs that make it onto the market (most notably the case of Vioxx), have brought increasing attention to corruption and lack of regulation in the..