NCHR Comments to FDA on Nicotine Replacement Therapy (NRT) Product Uses and Labeling Changes – February 15, 2018. It remains unclear whether individual achievement of abstinence is sustainable over time and whether long-term NRT use is more or less beneficial on an individual or population health level. We commend the FDA for addressing their role in developing strategies to evaluate NRT products and labeling. We agree that urgent action is necessary and the FDA should consider science-based approaches to reduce further harm from combustible tobacco products.
NCHR Comments on the USPSTF’s Evidence Review and Draft Recommendation Statement for Behavioral Counseling for Skin Cancer Prevention – November 6, 2017. We support USPSTF’s draft recommendations for behavioral counseling interventions to prevent skin cancer as well as their broader efforts to improve the health of all Americans by making evidence-based recommendations about clinical preventive services. As more information becomes available, we encourage the provision of additional recommendations about more specific behavioral interventions to prevent skin cancer for individuals in various subgroups.
NCHR Letter to the DC City Council on Artificial Turf – October 26, 2017. It is clear that city officials have assumed artificial turf products are safe because the salespeople told them they were safe. Unfortunately, there is clear scientific evidence that these materials are potentially harmful, and the only question is how harmful are they and how much exposure is likely to be harmful? Our children deserve better.
NCHR Comments on the USPSTF’s Draft Recommendation Statement, Evidence Review, and Modeling Report on Cervical Cancer Screening – October 9, 2017: The USPSTF proposes new cervical cancer screening recommendations. Surprisingly, the USPSTF proposes eliminating co-testing (pap and HPV test together) as a preferred screening approach in favor of the HPV test alone. Do the proposed recommendations deserve an “A” rating? Read our comments to find out.
NCHR Testimony at the FDA on Shingles Vaccine, Shingrix – An effective shingles vaccine is important for public health. As patients get older, they are more likely to develop long-term pain, or post-herpetic neuralgia (PHN), as a complication of shingles. This pain can be severe and chronic. There is no cure, and treatments do not reliably relieve pain for all patients. The only way to reduce the risk of developing shingles and PHN is to get vaccinated. We urge this Advisory Committee to recommend that the FDA require critical post-approval long-term studies to further evaluate the efficacy and safety of Shingrix. We also strongly recommend that the company conduct subgroup analyses to ensure that the vaccine is safe and effective for both women and men and also people of color.
NCHR Comments on CPSC Agenda and Priorities for FY2018-2019 – We are very concerned about exposures to phthalates in children’s toys and other products as well as endocrine-disrupting chemicals and other safety concerns related to recycled tire crumb rubber and other artificial turf, which the CPSC should also be concerned about
NCHR Comment on the USPSTF’s Draft Recommendations for Ovarian Cancer Screening – 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.
NCHR Comment on the USPSTF’s Draft Recommendations for Hepatitis B Virus Infection Screening in Pregnant 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.
Testimony at FDA Advisory Committee Oncology Meeting on Mylotarg (“GO”) – 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.
Testimony at the FDA Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting – June 21, 2017. Drug efficacy is a complex issue for children with chronic and/or rare diseases like the cancers discussed here. We commend the FDA and this committee for providing an open discussion focused on the best ways to test these five new drugs in pediatric populations.
Public Comments at the FDA’s Safe Use Symposium: A Focus on Outpatient Preventable Adverse Drug Effects – June 15, 2017. Bottom line: An important way for the FDA to help prevent adverse drug events is to make sure that patients know in advance what kind of choices they have for prescription drugs, and which ones are likely to be safer for them as women, people of color, patients over 65, and people with a particular illness. Patients deserve to know this information before filling their prescription.
Comments to FDA About Neratinib to Prevent Breast Cancer Reccurance – 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.
Remarks to the FDA Science Board on Patient Engagement – May 9, 2017. We respectfully urge the Board to carefully address these patient recruitment and safety issues as you advise FDA about implementing the 21st Century Cures Act. Engagement perspectives should include patients who have been harmed by medical products
NCHR Comment on the USPSTF’s Draft Recommendations for BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing – April 12, 2017. Based on its previous review, the USPSTF recommended risk assessment, genetic testing, and counseling for women with a family history of clinically important mutations in BRCA1 or BRCA2 genes.
NCHR Comment on the USPSTF’s Draft Recommendations for Breast Cancer: Medications for Risk Reduction – April 19, 2017. In their previous recommendation, USPSTF found that treatment with tamoxifen or raloxifene was beneficial for a subpopulation of women at increased risk. However, these treatments only slightly reduced the occurrence of invasive breast cancer in these women and came with serious risks
Patient, Consumer, and Public Health Coalition Senate Briefing: Innovation for Healthier Americans – These are the materials from the Senate briefing we hosted on March 4, 2016 with the Patient, Consumer, and Public Health Coalition titled “Innovation for Healthier Americans: The Impact of Proposed Health Bills on Patients & Consumers”.
Testimony of Dr. Anna Mazzucco before the FDA on “Framework for Regulatory Oversight of Laboratory Developed Tests” – By Dr. Anna Mazzucco January 8, 2015 Thank you for the opportunity to speak today at this very important meeting. My name is Dr. Anna Mazzucco, and I am speaking on behalf of the National Center for Health Research. I received my Ph.D. in cell biology from Harvard Medical School, and I conducted post-doctoral research … Continue reading Testimony of Dr. Anna Mazzucco before the FDA on “Framework for Regulatory Oversight of Laboratory Developed Tests”
Testimony of Dr. Anna Mazzucco before the EPA Scientific Advisory Panel – December 3, 2014. Research has implicated endocrine-disrupting chemicals in cancer, infertility, and other health problems. We must be able to quickly identify such agents in order to prevent them from entering our food and environment, and from affecting our health for generations to come.
Statement of Dr. Diana Zuckerman at FDA Joint Public Advisory Committee Meeting on Chantix – October 16, 2014. We strongly urge you to urge the FDA to keep the black box warning to protect patients and that you strengthen rather than weaken that boxed warning. And, since the meta analyses are fatally flawed, as I and others have pointed out, the FDA should delete the misleading meta-analyses info from the Chantix label.
Comments on “Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting” – October 9, 2014. To better evaluate the challenges in designing postapproval studies to determine whether a non-oncological drug causes or influences cancer, the FDA should develop long-term studies that include susceptible subgroups such as children, adolescents and the elderly.