Lorenzo's Oil Essay

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The movie Lorenzo’s Oil is based off a true story. Lorenzo Odone is diagnosed with an inborn error of metabolism disorder named Adrenoleukodystrpohy (ALD) in 1983. ALD is a sex-linked disease that only affects males born to mothers who are carriers of ALD. ALD causes a high amount of long-chain saturated fatty acids to build up in the blood and collects in the brain cells. ALD destroys the myelin sheath that covers the nerves in the brain. The destruction of the myelin sheath causes symptoms that generally occur in order. These symptoms are hyperactivity, inattentiveness, mutism (periods of not speaking), unsteady gait, blindness, deafness, decorticate posturing and death. Once diagnosed this disease causes death within two years. The movie focuses on Lorenzo’s parents Michaela and Augusto Odone struggle to find out what’s wrong with their son and their search for a treatment for ALD. After countless doctor…show more content…
This leads to the question on what are the FDA’s medication safety and pediatric trail requirements are. Children are considered a vulnerable population because in most instances they are unable to consent for themselves, and are left to other people like their parents to consent for them. This makes it difficult to conduct studies with children, and when studies are performed they are small. Protecting children is Subpar D; this evaluates the risks of the study. The FDA is regulated by two permanent acts the Pediatric Research Equity Act (PREA) and Best Pharmaceutical’s for Children Act (BPCA) to protect children. Subpar D evaluates the risk for the study. For the study to be a direct benefit there must be a low risk involved to the child. If the study puts the child at a high risk, then there needs to be extensive justification on why the study should

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