Our Bodies Ourselves, August 23, 2017. The “Ah-ha” moment came when several women told us that they had participated in clinical trials the FDA used as the basis for its approval. They told us that their reports of unrelenting, debilitating pain and other serious side effects were not included in the clinical trial data. Why? They said they were told by the doctors and nurses involved in the studies that the side effects were not caused by the device.
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How a Doctor Stirred National Demand for the Bridge Detox Device — Without Solid Evidence It Works
STAT News, August 23, 2017. The Bridge is a wearable device that supposedly helps opioid users deal with painful withdrawals, but the FDA has not yet said whether or not it will work.
Read More »Libertarians Score Big Victory In ‘Right-To-Try’ Drug Bill
Politico, August 3, 2017. The Senate unanimously approved a bill Thursday that would allow people facing life-threatening diseases access to unapproved experimental drugs.
Read More »FDA Documents Reveal Depths of Internal Rancor Over Drug’s Approval Process
August 2 2017: FDA emails show disagreements about a drug called eteplirsen. Some experts said it didn’t work well enough, but it was approved anyway, raising safety concerns. The National Center for Health Research says this shows the need for better rules to protect patients.
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