October 18, 2017. The USPSTF proposes a plan to review research and evidence on the benefits and harms of Hepatitis C virus screening in adults and adolescents. Our Center supports the efforts of USPSTF to reassess the merits of broad screening programs. We offer additional suggestions for an analysis plan that will inform future recommendations and best practice guidelines on this most important issue.
Read More »On Medical Treatments & Products
NCHR Comments on the USPSTF Draft Research Plan for Asymptomatic Bacteriuria in Adults: Screening
Not all bacteria is bad, and we don’t have to treat everything we detect. We urge the USPSTF to consider the new evidence for or against broad screening.
Read More »NCHR Comments at CDRH’s Voluntary Medical Device Manufacturing and Product Quality Workshop
October 10, 2017. Recalls demonstrate the crucial need for improved medical device quality, and for more clinical testing of such devices before they are put onto the marketplace, as well as improved inspections of manufacturing facilities prior to them going on the market. It’s a positive sign that this pilot program will address at least some of these inspectional issues.
Read More »NCHR Testimony at a Senate Panel on ECT
September 26, 2017. The new ECT devices are just as potentially dangerous as the old ones, and they should be required to be proven safe and effective. Everyone in this room has the power to do something about this, to convince FDA that ECT devices should remain Class III and should be required to be proven safe and effective before they can be sold.
Read More »NCHR Testimony at the FDA on the Use of Abilify for Treating Irritability in Children with Autism
September 12, 2017. We are particularly concerned about Abilify because of its well established serious side effects of tardive dyskinesia, tremor, muscle stiffness, and sudden cardiac death. Other risks include nausea, insomnia, anxiety, weight gain, high blood sugar, and high cholesterol. Moreover, the impact on a child’s developing brain is unknown because we lack high-quality, long-term research. The longer-term results indicated no significant difference between Abilify and placebo at week 16 in reducing the symptoms of irritability in pediatric patients who had already maintained a response for the first 12 weeks of Abilify treatment. Clearly the evidence for the effectiveness and safety of Abilify for children with autism and symptoms of irritability is insufficient to outweigh the risks, especially for girls and nonwhite children. We urge the FDA to revise the labeling to state that Abilify has not been proven effective in the long-term for this indication.
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