FDA Ban on Ephedra Has Been Spectacularly Successful!

6/2/2015 The FDA ban on ephedra has been spectacularly successful in preventing harm and death. Despite the fact that I regularly bust the FDA’s chops, I believe in giving credit where credit is due and the FDA has earned some in this case. The FDA banned the popular weight loss and energy boosting herbal supplement


Olympus Corporation Set Aside $450M for an Expected Settlement

6/1/2015 Olympus Corporation set aside $450M for an expected settlement regarding its marketing practices. It’s already on the hook for its duodenoscopes, which are very hard to clean and have caused a number of superbug outbreaks in the U.S. Olympus failed to timely warn hospitals in the U.S. and three people died. Now federal investigators



How long until Power Morcellators are Banned?

5/29/2015 Despite the ongoing FBI investigation of Johnson & Johnson’s manufacturing division, Ethicon, and a strong Food and Drug Administration (FDA) warning issued last year, power morcellators are still legal. The device grinds up tissue mass, and is then removed through a series of small incisions. The device, which is used to provide minimally invasive



FBI Investigates the Cancer-Spreading Hysterectomy Device

5/28/2015 Last year a Johnson & Johnson medical device, the laparoscopic power morcellator, was removed from the market. This year the FBI investigates the cancer-spreading hysterectomy device. The power morcellator was a favorite of surgeons for doing minimally-invasive hysterectomies and removing uterine fibroids. The device worked by grinding up tissue that could then be removed


Appeals Rulings Signal Punishment is Easing for Big Tobacco

  5/26/2015 Perhaps no industry besides investment banks has been hit as hard by the federal court system than tobacco over the past several years. A pair of recent appeals rulings, however, indicates a substantial turn in the industry’s decades-long financial flogging. On Friday, the D.C. Court of Appeals delivered a mixed-ruling, in which some



SGLT2 Drugs Have Negative History with FDA

  5/21/2015 Quite surprising to me, I found that SGLT2 drugs have negative history with FDA. Not surprising, especially after finding the history, is the warning FDA released earlier this week. It appears that canagliflozin, sold as Invokana, may have created problems in the clinical trials that should have prevented its release. Just as other


SGLT2 Clinical Research and Side-Effects

5/19/2015 The Food and Drug Administration’s (FDA) May 15th warning of potential ketoacidosis among Type II diabetes patients who use a new class of oral treatments known as SGLT2 inhibitors should not be completely surprising. The first such medicine approved by the FDA in March, 2013 was Invokana (canagliflozin), manufactured by Janssen Pharmaceuticals in conjunction