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 »On Medical Treatments & Products
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.
Read More »NCHR Comments on the USPSTF’s Draft Recommendation Statement for Falls Prevention in Community-Dwelling Older Adults
October 23, 2017. We support the USPSTF’s draft recommendations for exercise and multifactorial interventions, and against vitamin D supplements, given the available evidence. We recommend that the Task Force provide a caveat that these recommendations are not intended for older adults who are already known to have a vitamin D insufficiency; conduct subgroup analyses to determine the benefits and risks for sex, race/ethnicity, and two age groups; and integrate results of the NIH/PCORI study when they become available, as noted above. As more information becomes available about the effectiveness of particular components and intensities of exercise as well as other interventions, we encourage USPSTF to develop more specific recommendations for patients and providers.
Read More »NCHR Comments on the USPSTF’s Draft Recommendation Statement and Evidence Review on Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Fractures in Adults
October 23, 2017. After reviewing the available evidence, the USPSTF proposed new recommendations on the use of Vitamin D, Calcium, or combined supplementation for the primary prevention of fractures. The USPSTF proposes that evidence is insufficient to determine the balance of harms and benefits; however, a thorough review of the evidence shows surprising associated harms. Read on to learn more about this most important issue.
Read More »NCHR Testimony at the FDA about Type 2 Diabetes Drug, Semaglutide
October 18, 2017. In summary, we urge this Committee to recommend that the sponsor re-analyze the existing data to determine whether the benefits outweigh the risks for women of color, white women, men and women over 65, and other major demographic groups. We also recommend a longer follow-up of patients in the studies to determine safety, including appropriate evaluation of diabetic retinopathy. If there are too few patients in major subgroups to meaningfully evaluate risks and benefits, the sponsor should be required to add patients prior to FDA making a decision about approval. We urge this Committee to consider the safety and efficacy of Semaglutide within demographic subgroups and not subject patients to uncertain risk.
Read More »