Accelerated Drug Approval Program Failing to Control for Quality

The latest report from British Medical Journal reporters who investigated the FDA accelerated action program are showing that more than 2 in 5 drugs are not meeting the expectations for efficacy and quality. Maybe its time to consider alternative therapeutic models, especially for dementia and other neurodegenerative conditions that don't involve pharmaceuticals and can be self-administered at home by patients and their caregivers. Quietmind is working to engage in a comprehensive trial that will demonstrate the safety, reliability and efficacy of transcranial near infrared light therapy (tPBM) combined with brainwave biofeedback training. We've shown in expanded feasibility trials of tPBM conducted through Baylor Research Institute and Quietmind Foundation and our 15 years of clinical practice these tools are safe and rapidly effective in modifying cognitive and behavioral symptoms of dementia.

We hope to apply for accelerated action approval so that these therapies can be accepted and covered by Medicare and other insurances in the near future. Now, we are making the tPBM units available as wellness oriented interventions to support relaxation and improve overall cognitive and behavioral functioning. 

Click here for article: www.medscape.com/