An independent watchdog group, the Project on Government Oversight (POGO), found that the FDA’s approval of anti-coagulant drug Pradaxa was flawed. The POGO report details many poor decisions and conflicts of interest on the FDA’s part as it gave Boehringer, Pradaxa’s maker, several accommodations.
Researchers discovered that there may be a link between favoring bitter tastes, such as black coffee, and less-than-positive personality traits. In fact, the study showed that those who prefer black coffee are more likely to be vain, manipulative, selfish, sadistic and even psychopathic.
Bayer may have tampered with data from clinical trials and patient surveys pertaining to adverse effects caused by its Essure “permanent” birth control product. Patient surveys were altered, eliminating some valuable patient feedback. An advisory panel to the FDA met in late September to discuss Essure’s safety.
This equivocates to roughly one out of 49-50 women needing surgery to repair or remove the device. Dr. Sedrakyan also added that the “surgery is likely to be much more complicated than the laproscopic approach that they should be considering. For its part, the FDA has acknowledged the study, releasing a statement saying “This is a high priority issue for the agency. The FDA plans to review the findings of this study, along with the latest medical literature on the Essure device and input from panel members and the public during our recent advisory committee meeting, to determine what future actions may be appropriate.” The FDA has not indicated, however, that it is planning on pulling the device from the market.
New York’s AG is investigating Martin Shkreli of Turing Pharmaceuticals for possible violation of antitrust laws. It seems Big Pharma’s bad boy has set up a distribution network for the anti-parasitic drug, Daraprim, that will all but eliminate the possibility of generic competition. Needless to say, AG Eric Schneiderman is not pleased.
Bayer’s Essure implantable birth control device is responsible for destroying thousands of women’s lives. They have had total hysterectomies in their early 20s, been diagnosed with fibromyalgia, lupus and even cancer. All for the sake of Bayer’s almighty bottom line. No more! Hey Bayer! #ImReal and I’m not going away!
Despite the dosing concerns, however, the advisory panel voted 23-0 in favor of recommending Xtampza for approval. The FDA generally follows the advice of advisory panels, although it is not obligated to do so. While the FDA stated days prior to the panel meeting that Collegium’s packaging should contain a clearer warning about the dosing issue, it did not explicitly state that approval was contingent on labeling improvements.
A Louisiana man died from complications brought on by taking the anti-coagulant drug, Pradaxa. The new-gen drug has no known antidote that will counteract it’s blood thinning effects. In the event of a medical emergency, such as internal bleeding, patients must first endure multiple blood transfusions in order to remove Pradaxa from their systems.
The blast at the West Fertilizer plant killed 15 people altogether, injured 170, damaged nearby buildings and over 150 homes in the city of West, obliterating the plant, and even caused the equivalent of a 2.1 magnitude earthquake. With jury selection set to begin on Monday, authorities for the county told hundreds of prospective jurors on Sunday evening that they would not be needed for the trial involving the plant’s ownership and suppliers and the families of the deceased; Kevin Sanders, William Uptmor and Kenneth Harris. Waco District Court Judge Jim Meyer had divided the litigation regarding the explosion into three separate lawsuits, with the aforementioned case serving as a potential bellwether for the other two cases, which will contain hundreds of plaintiffs.
The 2-1 panel decision in favor of the attorneys general of 18 states follows a similar ruling issued in late August in North Dakota federal court in a separate lawsuit involving 13 states. That stay was ordered a day before the rule was to have gone into effect. The most recent ruling, which was a consolidated appeal of four separate lawsuits by the states and other interest groups, greatly expands the geographically-limited North Dakota decision and instead blocks the majority of the country from the Obama-led initiative.