NCHR Testimony at FDA about Buprenorphine Sublingual Spray, Buvaya

May 22, 2018: Opioids can be greatly beneficial and, as we all know too well, can also produce tremendous harms for patients suffering from pain. Buvaya presents concerning safety issues, its benefits seem minimal, and the delayed benefit for patients may result in overuse or misuse in the real world. Please carefully consider the risks of putting another non-abuse-deterrent opioid on the market and whether the sponsor’s attempts to reduce misuse and abuse are sufficient. We do not think so and more important, there is no evidence demonstrating that this product will be misused less often than other opioids. We therefore urge you to vote that the benefits of Buvaya do not outweigh its risks.

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NCHR Comment on USPSTF’s Draft Recommendation Statement Screening for Intimate Partner Violence and Elder Abuse

May 21, 2018. In conclusion, we agree with the USPSTF’s efforts to provide updated recommendations on screening of IPV and abuse based on quality, up-to-date studies. The benefits of screening for IPV for women outweigh the risks, and future studies should allow recommendations to be made for other populations. We agree with the USPSTF draft recommendation on IPV and elder abuse.

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NCHR Comment on FDA’s Draft Guidance on Developing Drugs for Early Alzheimer’s Disease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