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.
Late last month, an advisory panel met to determine recommendations to the FDA on the controversial “permanent” birth control implant, Essure. This comes in the wake of numerous suits and tens of thousands of women reporting serious injuries caused by the device. Bayer, Essure’s manufacturer, still swears by its product’s safety. The real question is: did Bayer lie about Essure?
While the panel’s recommendations need FDA approval before implementation, many Essure patients, patient advocates and independent researchers feel that the answer to the question is, “Yes.” Evidence points to flaws in the clinical trials and, worse yet, actual data tampering.
Diana Zuckerman, President of the National Center for Health Research, said, “When we first looked at the studies, Essure looked like a great product with few complications. But when I talked to women with Essure, it was a very different story.” Updated to correct quote.
Dr. Zuckerman found that surveys of women’s experiences with Essure had been altered if their response to whether they’d had pain or other adverse health issues was “yes.” Not only were those answers sometimes changed to “no,” but also certain comments about the women’s pain were crossed off.
I agree with Dr. Zuckerman’s statement: “When you do that to the data you are basically manipulating the data, some people would call it fraud.”
Her research into the clinical trials began after she found thousands of injured women on Facebook. These “e-sisters,” such as Mechanicsville mother Lacy Bradley, have serious and unanswered complaints about the product, a tiny nickel coil that is inserted into the fallopian tubes.
Bradley says, “I woke up in the middle of the night covered head to toe in hives.” ABC’s 8News found 5,000 complaints to the FDA ranging from allergic reactions, such as Bradley’s to uterine perforations, pregnancy, fibromyalgia, Lupus and even cancer.
Bayer’s response to the alteration of patient surveys is pathetic at best: “We strongly disagree with the characterization of the changes made to the referenced clinical trial records, which were initialed and dated. Some of the changes provide further information about the patient’s symptoms.”
Sure. Redactions of patient comments always provide “further information.”