The US Food and Drug Administration sparked a storm of controversy after it approved a new drug for Alzheimer’s disease by granting it approval, ignoring the recommendation of the Food and Drug Administration’s external advisory committee to reject it.
In response to the questions of the (With Al-Hakim) program on Al-Jazeera Mubasher about this matter, Dr. Fawzi Abu Khalil, a consultant neurologist and assistant professor at the Institute of Neurological Diseases in Miami, said that this is done when positive scientific evidence is reached during the study, which is reflected on the patient.
He explained that urgent approval is granted to many drugs, such as cancer drugs, AIDS and multiple sclerosis, which means “accelerated production of the drug,” noting that this happened before in a cancer drug when it was proven that the drug reduces the size of the tumor.
Dr. Fawzi Abu Khalil revealed that the new drug has been shown to reduce the formation of beta-amyloid plaques in patients with early stage Alzheimer’s disease by 30%.
He explained that (amyloid beta) is the toxic proteins that accumulate to form plaques in the brains of Alzheimer’s patients, and these plaques are the main trigger for the signs and symptoms of Alzheimer’s disease.
Regarding the usefulness of this in the treatment of Alzheimer’s disease, Dr. Fawzi wondered about the practical effect of this percentage on patients in terms of an improvement in memory and cognition, stressing that this needs studies, and for this reason some were skeptical and criticized the decision.
He said that two studies were conducted, the first started in 2011, and a second study spanned 4 years from 2015 to 2019, and included two studies, one of which demonstrated an improvement in patients’ cognition, while the other did not.