August 10, 2017. We support the efforts of the U.S. Preventive Services Task Force (USPSTF) to re-evaluate its 2012 grade “D” recommendation in light of new results from a large study, the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). This study confirmed that screening for ovarian cancer does not decrease deaths from ovarian cancer in asymptomatic women who are not known to be at high risk for ovarian cancer. Based on the USTSPF’s robust review of the literature, we agree that there is insufficient evidence to support screening for asymptomatic women.
August 9, 2017. The U.S. Preventive Services Task Force (USPSTF) last reviewed the literature in 2009 and reaffirmed their “A” grade for HBV screening for women at their first prenatal visit. We support the efforts of the USPSTF to carefully draft a research plan to guide the systematic review of available evidence for universal screening and case management programs to prevent vertical transmission of the infection as well as reduced rates of morbidity and mortality. We also endorse the efforts of the USPSTF to obtain updated information on the harms and benefits of universal screenings and case management programs for women with Hepatitis B.
July 12, 2017. Given the research design, only one pivotal study, the lack of U.S. patients, and a less than convincing literature review, the data do not support sufficient support for approval. The studies, in our view, do not provide strong evidence that GO is effective and there are still continuing safety concerns.
June 21, 2017. Thank you for the opportunity to speak today. My name is Dr. Megan Polanin. I am a Senior Fellow at the National Center for Health Research, and I previously trained at Johns Hopkins University School of Medicine. Our research center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from pharmaceutical companies, and therefore I have no conflicts of interest.
June 15, 2017. Thank you to the FDA and the Safe Use Team for hosting this meeting and for the opportunity to share our perspective. I’m Dr. Megan Polanin, and I am a Senior Fellow at the National Center for Health Research.
May 24, 2017. The FDA should be sure that new treatments provide a real benefit to patients before they are approved. We recommend that the FDA not approve neratinib for breast cancer unless a clear benefit can be replicated, or a benefit for overall survival is demonstrated.