June 14, 2018. The pivotal trial does not provide sufficient evidence for effectiveness or safety. Questions about whether the device is effective are exacerbated by the lack of consistency with the crossover data, the differences between US patients and those outside the US, and the lack of blinding. The long-term follow up data are difficult to interpret without controls.
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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.
Read More »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.
Read More »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.
Read More »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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