Recent News

The Journal of the American Medical Association

Study Group Demands JAMA Retract Low-T Study

An ad hoc group of medical professionals is demanding the Journal of the American Medical Association (JAMA) retract an influential study that connects testosterone therapy and cardiovascular problems and investigate a possible ethical breach by the publication’s editorial board. The Androgen Study Group said JAMA violated ethical standards, created baseless concerns and “birthed a new […]

Aug 14, 2014

FDA Fast Track

FDA Tightens 510(k) Program but Fast-Track for Medical Devices Remains

The Food and Drug Administration (FDA) will tighten up the standards of its controversial 510(k) program, narrowing the scope of how medical device makers can take new products to the consumer market. But the program will remain intact, and companies will continue to have a way to fast-track product development without having to go through […]

Aug 12, 2014

Power Morcellators Recalled

Uterine Cancer Concerns Lead Johnson & Johnson to Pull Power Morcellators

Pharmaceutical giant Johnson & Johnson recalled three laparoscopic power morcellators from hospitals worldwide as a growing body of evidence points to the spread of cancer as a result of morcellation procedures. The company’s Ethicon division said the “worldwide voluntary market withdrawal” is the next step following the company’s April suspension of device sales and distribution. […]

Aug 5, 2014

Blood Thinner, Xarelto

First Xarelto Bleeding Lawsuits Filed; FDA Rejects New Use

Drug giants Bayer and Johnson & Johnson face the first lawsuits related to safety concerns for the billion-dollar blood thinner Xarelto, according to Reuters. Plaintiffs filed claims after severe internal bleeding sent them to the hospital. In those cases, patients took Xarelto (rivaroxaban), and their claims blame the excessive bleeding on that use. Unlike warfarin, […]

Aug 4, 2014

Testosterone Therapy Drugs and Supplements

Testosterone Drugs Not Effective in Men with Type 2 Diabetes

Testosterone therapy did not help aging, obese men who have Type 2 diabetes and reduced testosterone levels with sexual symptoms and general health, a new study shows. Berlin-based Bayer Pharma AG who makes the testosterone drug Nebido funded the study published in The Journal of Clinical Endocrinology & Metabolism. Researchers found it is unlikely that […]

Jul 28, 2014

power morcellation

FDA Pushes for Warning on Power Morcellators, Informed Consent

Members of a specially formed Food and Drug Administration panel say there is not enough evidence to prove using power morcellators to remove uterine fibroids does not increase the risk of spreading undetected cancer – a risk that may be more common than previously thought. During a recent two-day meeting, the FDA health advisors concluded […]

Jul 16, 2014