NCHR Testimony at the FDA on Optimizer for Heart Failure

December 4, 2018. We all want to help these patients, but  new treatments need to provide a real benefit.  The questions that we need to answer are does this device help patients and should patients continue to have the option of receiving an experimental treatment as part of a clinical trial, or should they pay for an experimental treatment that has been described as a breakthrough?  

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NCHR Testimony on the Opioid Buprenorphine/Samidorphan for Depression

November 1, 2018. The clinical trial data do not provide adequate evidence that buprenorphine/samidorphan reduces the symptoms of depression. There are concerns about it potential for long-term harms to patients and others who might misuse or abuse it. BUP/SAM needs to provide strong evidence of efficacy before approval.

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NCHR Testimony on the Opioid Oliceridine

October 11, 2018. There are many unanswered questions about what dosages work and are safe for which patients under which conditions. We all know that is an epidemic of opioid use, so these questions must be answered before a decision is made about whether or not to approve oliceridine.

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