November 16, 2017. We do not know enough to approve this drug for people who really need it, and we respectfully urge you to consider the inadequacy of the current data. We recommend further study of this drug with clinically meaningful primary endpoints, such as severity of exacerbation, overall lung function, and patient-reported outcomes to directly assess patients’ symptoms such as cough, wheezing, and sputum production. We also recommend comparing the drug to a non-powder to ensure that the method of use does not worsen symptoms and including more patients 75 and older.
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.
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.
Read More »Are “Gummy Bear” Breast Implants the Safer Implants?
Nova Science Publishers, 2017. Thinking about breast implants? Our new book chapter tells you what you need to know.
Read More »NCHR Testimony at the FDA about Depot Buprenorphine, RBP-6000
October 31, 2017. In conclusion, to reduce deaths and addiction due to opioids, we must demand more from everyone. Prescribers must be better informed, REMS and ETASU (Elements to Assure Safe Use) must be sufficiently stringent, and scientific methods used to assess treatments must be sound. Given serious risks and concerns outweigh this drug’s minimal benefits, we cannot recommend approval of this drug based on current data.
Read More »NCHR Testimony at the FDA about Depot Buprenorphine, CAM2038
November 1, 2017. In conclusion, we all want more options to reduce opioid addiction, but if the FDA approves treatments that are less safe and less effective than those already available, we are worried that this will not help. Scientific methods used to assess treatments must be sound. Specific doses need to be evaluated for safety and effectiveness based on reasonable sample sizes for at least 24 weeks. Given potentially serious risks that outweigh this drug’s minimal benefits, we cannot recommend approval of this drug based on current data.
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