September 9, 2014. We share the FDA’s reservations about the clinical relevance of the small reductions in blood pressure. We question whether approving this combination drug will make a difference in patients’ health.
Read More »On Medical Treatments & Products
NCHR Testimony at FDA Advisory Panel on TissuGlu
August 1, 2014. The product was NOT studied on cancer patients and definitely should not be approved for them. In fact, the label should specify that it has not been studied on cancer patients.
Read More »NCHR Testimony on Ablatherm High-Intensity Focused Ultrasound Device
July 30, 2014. Prostate cancer is a very common cancer and all the current treatments have serious side effects that harm men’s quality of life. The question today is whether the Ablatherm high-intensity focused ultrasound device is safe and effective for the treatment of low-risk, localized prostate cancer. Most men diagnosed with localized, low-risk prostate cancer will not die from prostate cancer, but from something else.
Read More »NCHR Comments Urging FDA to Provide Higher Standards And Upclassify Surgical Mesh For POP And Incontinence
July 30, 2014. On behalf of the National Center for Health Research, I am pleased to have the opportunity to express our views on the proposed order on the reclassification of certain surgical mesh devices and surgical instruments. Our nonprofit Center analyzes and reviews research on a range of treatment issues, and provides objective and understandable information to patients and providers.
Read More »NCHR Testimony to the Obstetrics and Gynecology Devices Panel Morcellation Devices for Uterine Fibroid Removal
July 11, 2014. We need higher standards to ensure that morcellation devices are safe and effective, and that require clinical trials with sufficient numbers of patients to determine the risks of rare but fatal outcomes.
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