NCHR Testimony at FDA on Approval of Abuse-Deterrent Opioid, Remoxy

June 26, 2018: To reduce the opioid epidemic, the FDA must hold pharmaceutical companies to a high and truthful standard. Remoxy did not meet the FDA’s standards for oral abuse, and it remains unclear whether it can be abused intravenously. The safety of the excipient is also in question. Please carefully consider the risks of putting another drug with abuse-deterrent labeling on the market that could result in misuse and abuse in the real world. We urge this Advisory Committee to vote that the benefits of this drug do not outweigh its risks.

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NCHR Testimony at FDA on ELEVAIR Endobronchial Coil System

Stephanie Fox-Rawlings, National Center for Health Research: June 14, 2018 Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Stephanie Fox-Rawlings. Our Center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept […]

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NCHR Testimony at the FDA about a Circulatory System Device

June 12, 2018. Since it is a high-risk device, the INCRAFT AAA Stent Graft System should be held to a high standard for approval. As you determine whether you have reasonable assurance of this device’s safety and effectiveness, we urge you to consider the benefits and risks for patients.

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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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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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