The Process of FDA Approval

During Dr. Michael Decker's discussion of treatments for Alzheimers Disease, he highlighted the strenuous process necessary to get certain treatments approved by the FDA. Most potential treatments will either run out of funding due to the billions of dollars that it costs to research these drugs, or will go through many trials just to result in an ineffective treatment, setting back the researchers many years. Dr. Decker further states that almost all treatments will fail due to the intense, but necessary steps in order to achieve FDA approval. Once a new drug is discovered, it must first be tested on animals in a lab before being sent to the next phase. After passing this preclinical development, it will then be tested on humans in three phases. Phase I determines if the drug is safe for humans, phase II determines if the drug is effective, and phase III determines if the drug will be safe and effective in the general population, typically tested on thousands of patients. Then, in the slight chance that a drug passes through all of these stages, the FDA will then review the drug, determining if they will approve it or deny it.

Many drugs show significant potential that are currently in development, and therefore cannot be administered to the people who are in need of the drug. An example of this is all of the promising research towards a drug that can potentially cure glioblastoma, which is a very deadly form of brain cancer. This form of cancer mutates and disperses throughout brain tissue very quickly, which is the main reason that the survival rate for glioblastoma is very low. However, researchers at Duke Cancer Institute have discovered a treatment that could indefinitely halt the progress of the tumor growth. This study entered phase I of clinical trials over three years ago, and only recently the group has begun phase II trials. The reason for this extended period of time is due to the fact that they need to . make sure that the treatment works and will not cause any adverse side effects in the patients. Due to the complexity of the cancer, and high fatality rate, measuring the effectiveness of the therapy in phase II will be very difficult and will most likely take an even longer time to get cleared for phase III.

There are many other drug treatments that are in these stages that could significantly benefit certain people now. It raises many contrasting questions regarding FDA approval and the administration during clinical trials. On one hand, one could argue that these drugs should be administered to a wider selection of people depending on the severity of their condition. For example, someone with glioblastoma could have a life expectancy of one year, but due to FDA regulations, they will not be able to receive this new treatment in time to save their lives. On the other hand, one could argue that the FDA must be thorough in the drugs that they administer to patients in order to avoid any potential harm that may occur from a new treatment.

Feuerstein, Adam. Poliovirus Therapy Shows Early Promise for Treating Aggressive Brain Cancer, but Questions Linger. Scientific American, 27 June 2018, www.scientificamerican.com/article/poliovirus-therapy-shows-early-promise-for-treating-aggressive-brain-cancer-but-questions-linger/.

Mohs, Richard C., and Nigel H. Greig. “Drug Discovery and Development: Role of Basic Biological Research.” Alzheimer's & Dementia: Translational Research & Clinical Interventions, vol. 3, no. 4, 2017, pp. 651–657., doi:10.1016/j.trci.2017.10.005.