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.
Health & Medicine
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!
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.
Congressman Fitzpatrick’s law simply reads: “Not later than 60 days after the date of enactment 8 of this Act, the Commissioner of Food and Drugs shall issue an order under section 515(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(e)) withdrawing approval for Essure System.” Essure Problems is also asking others who have experienced complications from the device to also send their Representatives this letter (which is provided in Word Doc. Format at the bottom of the page).
Pfizer is grumpy because the FDA wants to add additional cautionary information for pregnant women to the Zoloft label. Despite internal memos stating that the Big Pharma giant’s own scientists have been warning management for years that there are increased risks for birth defects, Pfizer is resistant to the label change, stating that there isn’t enough data to support it.
The FDA is adding another warning to the label of popular type-2 diabetes drug, Invokana. The drug, part of a new class, is already under scrutiny for increasing the risk of ketoacidosis and kidney failure. Now, armed with several studies, the FDA has reason to believe that Ivokana may cause low bone density and fractures.
Johnson & Johnson and its subsidiary, Ethicon, won the first case involving the company’s Gynecare Prosima pelvic mesh to go to trial. The plaintiff, Carol Cavness, had asked for $9.5M in damages for past and future medical expenses, pain & suffering and an unspecified amount in punitive damages. The jury decided in favor of J&J with a 10-2 vote.
We have the answers for you panel members, we have the answers for you FDA, all you have to do is ask us and we will show you. I am not a doctor, I am a metal smith. But that does not make my knowledge of Essure less real, it doesn’t make our knowledge or our information untrue. We can present to you allergy reports, operative notes, toxicology reports, blood work, x-rays, CT scans, MRIs, radiology reports, we have the medical information right in our hands.