December 21, 2017. We applaud the FDA for addressing their role in developing strategies to “confront” the opioid crisis. We agree that the magnitude and scope of this crisis requires urgent action and agree that the FDA should consider patients’ and other relevant groups’ interests in developing effective approaches to reduce further harm from opioids.
Read More »On Medical Treatments & Products
NCHR Testimony at the FDA about New Spine Device, Barricaid Anular Closure
December 12, 2017, Patients who suffer with back pain need better alternatives for long term relief. The Barricaid device might be the answer, but the limited data provided suggests it is unlikely to offer the kinds of benefits that patients need. The study indicates substantial device failures. Its use in limited discectomy remains unknown, because most subjects had more extensive surgeries. In addition, the short-term benefits appear to be modest and wane after 24 months. Long term studies with blinding conducted inside the US may provide more certainty, but at this time the data are insufficient to recommend approval.
Read More »NCHR Comments on the USPSTF Draft Recommendations for Osteoporosis Screening
December 5, 2017. We strongly suggest the USPSTF provide a separate and clear “D” recommendation against screening in premenopausal women younger than 65. We strongly recommend that the USPSTF not finalize its recommendations until further information is made available regarding the direct benefits and harms of screening as noted above. In addition, we strongly urge that the evidence supports that the harms of drug therapies are “moderate” or “moderate to severe” and these risks be compared to the lack of evidence that these drugs reduce hip fractures, rather than concluding that the benefits are substantial and the risks are “no greater than small.” Last, we urge that USPSTF examine the benefits and harms of non-drug therapies as part of its screening recommendations.
Read More »NCHR Testimony at the FDA about Ciprofloxacin Dry Powder Inhaler (DPI) for Non-Cystic Fibrosis Bronchiectasis
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 »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 »