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.
Read More »We’re Speaking Out on Health Issues
NCHR scientists and health policy experts provide written and oral statements on a wide range of topics.
Here are many of the ways we have been Speaking Out on Health Policy Issues for the last few years. Whether the topic is legislation intended to cure diseases, proposed bans on BPA or other chemicals that disrupt your hormones, the importance of including women, people of color, and patients over 65 in clinical trials, or many other topics, you’ll gain a better understanding of our evidence-based analyses by reading these letters, statements, and testimony.
Here are the ways we have been Speaking out on Medical Treatments and Products, such as prescription drugs and medical devices that the FDA is considering approving, or is considering taking off the market because of serious risks. Whether the topic is Chantix, Addyi, Yaz, Essure, or medical products you’ve never heard of, you can find out more about what is known and not known about the safety and effectiveness of a wide range of products by looking through this section of our website.
Here are our Statements and Positions on issues that affect you.
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.
Read More »NCHR Testimony at the FDA about Pediatric Labeling for an Opioid
It is important for this panel and the FDA to make decisions about drug labeling based on good science and strong data. We concur with the 2016 Advisory Committee that because pediatric patients are vulnerable to drug use and addiction due to ongoing brain development; proper prescribing, patient selection, and education are crucial to optimize safety in this population. Results of Study 3031 do not provide sufficient evidence to inform health care providers about the safe use and proper dosing of Butrans in the management of pain for pediatric patients. We urge this Advisory Committee to advocate for pediatric patient safety and urge the FDA to require that the drug be appropriately evaluated before allowing information about Butrans to the pediatric section of the labeling.
Read More »NCHR Comments to CPSC on the Organohalogen Flame Retardant Petition
September 14, 2017. In order to keep our children safe, it is essential to regulate OFRs collectively as a class unless and until there is scientific evidence that one or more particular OFRs is proven to be safe, and then treat that specific OFR differently.
Read More »NCHR Comment on the USPSTF’s Draft Research Plan for Abdominal Aortic Aneurysm Screening
We support the efforts of the U.S. Preventive Services Task Force (USPSTF) to carefully draft a research plan to guide the systematic review of available evidence for primary care screening to identify and treat AAA. We have two recommendations that would strengthen the USPSTF draft research plan.
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