NCHR Testifies Against Oral Testosterone Drug

January 10, 2018. Testosterone replacement therapy can substantially benefit patients with hypogonadism. While we recognize that oral administration is preferable to more inconvenient routes of administration, we cannot disregard concerns about this drug’s potential harms. This drug was not studied for a long enough time to know if the benefits outweigh the risks, and off-label use makes it even more likely that the risks will often outweigh the benefits.

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NCHR Testifies Against New Testosterone Pill

January 9, 2018. Testosterone replacement can help patients with hypogonadism live a normal life. A new oral drug might be beneficial, but this drug raises concern of potential harms. On a chemical level, the drug works, but we don’t know whether it meaningfully helps patients in the long run. Long term studies with patient-centered outcomes may provide more certainty. In addition, the data do not provide reasonable assurance that this drug is safe. We need additional safety data and drug interaction data before this drug is approved. Furthermore, if we consider potential misuse as part of the risk/benefit evaluation, then the potential for harm surely exceeds the drug’s benefits. Therefore we cannot recommend approval at this time.

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NCHR Comments on the FDA’s Opioid Public Steering Committee (OPSC)

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.

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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.

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