Doubt Surfaces about Clinical Trials
Bayer and Janssen Pharmaceuticals failed to inform users of potential risks linked to Xarelto. Xarelto's Risks and Lawsuits. It is still several months before evidence is to be presented in court against the manufacturers of Xarelto. As of July 2016, the number of lawsuits involving the anticoagulant approaches the 6,000 mark. … [Read more...]
Risperdal Researcher Promised Drug Maker Positive Results
Risperdal Researcher Promised Drug Maker. A prominent Harvard psychiatrist promised positive results to Johnson & Johnson before the start of some clinical trials for Risperdal. According to The Wall Street Journal, the revelations regarding Dr. Joseph Biederman came to light in court documents that are part of a lawsuit … [Read more...]
Drug Clinical Trials Being Outsourced With Little FDA Oversight
Drug Clinical Trials Being Outsourced. Drug makers are increasingly outsourcing the running of clinical trials to outside companies, known as Contract Research Organizations (CROs). Clinical trials are meant to test the safety and effectiveness of experimental drugs before they come to market. Yet despite the importance of such … [Read more...]
FDA Issued Ketek Warning Letter
A Ketek clinical trial was rife with irregularities including fraud, but the drug’s maker, Aventis never acted on reports about problems with the study. Now, the Food & Drug Administration (FDA) has sent a Warning Letter to Sanofi-Aventis, the successor of Aventis, outlining various instances of misconduct by doctors … [Read more...]
FDA Approved Ketek Despite Irregularities
FDA Approved Ketek Despite Serious Irregularities Patients being treated with Sanofi-Aventis’ antibiotic Ketek faced serious liver damage or even death, when all that was being treated was a simple sinus infection The story of the dangerous prescription drug Ketek and how it came to be on the market is a case-study in … [Read more...]