Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices

The US Food and Drug Administration (FDA) approves about 400 implanted medical devices each year through an abbreviated process called the 510(k) process, which only rarely requires clinical trials (studies of patients). Continue reading

Avandia: What’s Known and Not Known

Since heart disease is the #1 cause of death among diabetics, it is reasonable to ask why a diabetes drug that possibly increases rather than decreases the risk of heart disease should remain on the market. Are warnings enough to keep patients safe? After looking at the study results, many experts are urging that patients and doctors consider whether older drugs for diabetes may be safer and more effective–as well as much less expensive. They are asking: should Avandia remain on the market? Continue reading

Essure Study Criticized

NBC News, November 4, 2013. Dr. Diana Zuckerman, who leads the National Research Center for Women and Families, a non-partisan FDA watchdog, said the survey questionnaires exhibit dubious research methods. “These studies are always done by the company that is selling the product so it is not exactly unbiased,” Zuckerman said. Continue reading