NCHR Comment on FDA’s Draft Guidance on Developing Drugs for Early Alzheimer’s Disease

May 16, 2018. We support the encouragement of research to develop drugs that would prevent or slow the progression of early Alzheimer’s disease (AD). We support the FDA’s recognition of the importance of efficacy endpoints that demonstrate a clinically meaningful effect on daily function and/or cognition for drug development. It is not appropriate to depend entirely on the use of biomarkers and of limited, narrow measures of neuropsychological performance. It will be important that when these newly developed drugs are evaluated for approval that the FDA maintains high standards for evidence that are based on sound science.

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Statement of National Center for Health Research Supporting A CDC Review to Save Women’s Lives

The National Center for Health Research strongly supports the announcement that the Centers for Disease Control and Prevention may conduct a review of the potential benefits of biopsies for women scheduled for hysterectomy or fibroid removal.  The review is essential because a recent article, published in the medical journal Obstetrics & Gynecology  reports that the rate of unsuspected cancer is dangerously high in women undergoing hysterectomy.  When those women undergo surgery, particularly procedures involving a medical device called a power morcellator, the cancer can spread inside the woman’s abdomen, resulting in an early-stage cancer being upstaged to a much more dangerous metastatic (stage 4) cancer.  The risks  are especially high for women ages 55 and older, reaching almost 10% for undiagnosed uterine cancer.

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NCHR and NPA Comments at FDA Advisory Committee on New Treatment for Antibiotic-Resistant Bacteria

May 2, 2018, We urge the panel to recommend that FDA require additional well-designed superiority studies that use appropriate statistical methods to determine whether plazomicin cures infections and saves lives for patients who have no other options. With reliable methods, even small studies can show a clinically meaningful and significant benefit. Since there is no evidence that plazomicin works or is safe for patients who have no or limited options, approval will do more harm than good.

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Letter to Board of Education of Montgomery County on Synthetic Playgrounds

April 23, 2018. Many of the synthetic playground materials being used contain carcinogens, and when children are exposed to those carcinogens day after day, week after week, and year after year, they increase the chances of our children developing cancer, either now or as they get older. That should be adequate reason to not install them in Montgomery County.

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