The Food and Drug Administration (FDA) is responsible for the safety of medications sold in America. Unfortunately, their procedures aren't perfect and sometimes a faulty product can slip through. Ketek is one of these products. Ketek is a drug manufactured by Aventis (now Sanofi-Aventis) designed to treat sinusitis. When Ketek was introduced to the FDA, the FDA requested that Aventis prove that the drug was at least as effective at treating sinusitis as those drugs already on the market. Aventis subcontracted the research to PPD, a third-party company. PPD, however, did not always practice proper research techniques. In this situation, they offered doctors $400 for every patient they enrolled in the Ketek trial.
One doctor in the study had enrolled (and been paid for) over 400 patients. An auditor for PPD investigated this doctor and determined that he had enrolled friends, family, and patients who didn't even know they were in the trial. When the auditor filed a formal report to PPD, no action was taken against the doctor and his fraudulent results were included in the study. It wasn't until the FDA conducted their own audit that the faulty results were found and the doctor was faced with criminal charges. Aventis denied knowledge of the deceitful research techniques used by PPD, though evidence suggests otherwise. By the time the FDA investigated the study, however, the drug was already on the market and patients were suffering liver failure that wasn't found in the tests. Though the FDA did not intentionally allow the improper research to take place, it is clear that the organization's procedures still allow for deceitful drug companies to cut corners at the cost of patients' lives. If you or someone you love has been injured by Ketek or any other faulty medication, my recommendation is to contact a personal injury attorney and make sure your injuries are fully compensated.
Posted by:
Personal Injury Lawyer Michael Grossman
| Posted on:
4/28/2010
| Comments (0)
As a Texas attorney practicing for 20 years, I have litigated all manner of personal injury cases. I use this blog as a place to write opinion / editorial articles on a variety of topics that catch my interest and as a means of sharing news stories relevant to personal injury accidents. I think the overwhelming majority of people are unaware just how common these types of accidents are and I hope this blog raises awareness to rather serious public safety concerns. However, this blog is simply a means for me to share my opinions and I would recommend that anyone who is considering seeking legal counsel should contact their family attorney.
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