A Drug with Potential or a Scientifically Proven Headset?
Alzheimer’s disease, a progressive brain disorder that targets memory and other brain functions, affects six million Americans and in a desperate bid to help, the U.S. Food and Drug Administration (FDA) recently approved Aduhelm (aducanumab). Its approval has caused a public uproar, disapproval from scientists, and three of the FDA’s independent advisory panel members resigning due to disapproval with the decision. On the other hand, Vielight devices have had multiple successful clinical trials in the fight against neurocognitive disorders.
The approval for Biogen’s Aduhelm occurred through the accelerated approval pathway, an FDA process that fast-tracks drug approval not based on direct evidence of the drug’s efficacy, but on predictions of potential benefits based on completed clinical trials. A future clinical trial proving the expected benefits do occur is also required to keep the drug approved.
The approval was made after two clinical trials occured based on the hypothesis that Aduhlem shows a dose-and time-dependent reduction of amyloid beta plaques, which are unnaturally high in Alzheimer’s patients. However, one of the trials showed no effectiveness of the drug, the FDA’s independent advisory panel recommended against approval of the drug, and Biogen had internal disagreements regarding the drug’s efficacy.
Scientists such as Dr. Paul Aisen, director of the University of Southern California’s Alzheimer’s Therapy Research Institute in San Diego and a paid adviser to Biogen, criticizes the claim that Aduhlem’s removal of amyloid plaques correlates with lowering the progression of Alzheimer’s. Although Alzheimer’s has been researched extensively, whether or not removal of amyloid plaques would benefit Alzheimer’s patients has not been proven.
Aduhelm is now a FDA-approved $56,000 a year drug and shows potential benefits against mechanisms thought to be connected to the disease, but it has yet to show direct evidence of combating the disease. On the other hand, a neuromodulation device, Vielight, which is modestly priced at $500 – $2,400, has direct evidence indicating improvements in memory and behavior in Alzheimers, Parkinsons and other neurocognitive disorders based on early trials. Its effectiveness against neurocognitive disorders is based on photobiomodulation mechanisms that give the brain energy using near-infrared light. This neurostimulation increases blood flow, reduces inflammation, promotes tissue repair, and energizes brain metabolism overall. The devices are currently being fast-tracked through FDA clinical trials and can be found at https://www.vielight.com/. Brain Builders Neurotherapy can help you select which device might be beneficial for you, and provide a code to receive 10% off the purchase price. Vielight stands by this product and will refund 70% of the purchase price within a six month trial period. Visit our website at http://norcalbrainbuilders.com/.