On February 18, 2006, 15 year old Jessica Ray attempted suicide, while just 23 days earlier, she had been prescribed the antidepressant Prozac without being warned of the increased risk of suicide in adolescents that Prozac can cause. Prozac was prescribed to Jessica Ray off-label, meaning it was used in a way that was not suggested on the drug label itself (Floyd v. U.S). Though pediatric clinical trials started in 1718 when smallpox was running wild all over Eurasia, not enough trials have been performed on minors. A lack of clinical trials simply means not enough drugs/treatment plans are available for those under 18. This means children either aren’t getting treatment at all, or their treatment is administered in an unsafe way. Minors
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The first difference between children and adults starts with the smallest component of life: the cell. In his book The Cell, Geoffrey Cooper, a biology professor at Boston University, says that cells in children reproduce much faster than in adults to keep up with the children’s rapidly developing bodies. This is extremely important for the development of medicine for children because if a child were to get cancer, that cancer has a higher rate of advancement because of the fast-replicating nature of the cancer cells. Children also have small, fragile bodies that must be treated very delicately. In his article “An Overview of Anatomical Considerations of Infants and Children in the Adult World of Automobile Safety Design”, family medicine doctor Donald Haulke writes that the bones of children are more susceptible to breaking than adult bones because of their small diameter. When treating children for health problems like bone cancer, it’s important to have a treatment plan that takes childhood fragility into account. Just because a treatment plan works on the durable bodies of adults does not mean that the same process will work on the …show more content…
Clinicaltrials.gov, where all clinical trials must be registered, reports that from July 2005 to September 2010, only 5035 (7%) registered trials enrolled the pediatric population (Pasquali et al.). This shows how much of a shortage there is regarding pediatric clinical trials. Consequently, a shortage of trials means a shortage of treatment plans designed specifically for children, so doctors are forced to administer adult drugs. Dr. Tewodros Eguale, a research scientist and associate professor at Massachusetts College of Pharmacy and Health Sciences, says that if there is no accessible data suggesting a drug will work if used off-label, negative drug events become 54% more common (Esposito). Doctors are really only trying to help children, but there is no sufficient data backing up their desired treatment plan, and that makes it hard to properly treat the children. If pediatric clinical trials were more common, more data would be accessible to doctors, and less children would be likely to suffer the consequences of taking a drug not designed for them. Further enforcing the fact that not enough pediatric data is available to doctors, the article “Off-label Use of Drugs in Children” by the Committee on Drugs (a group of pediatric drug specialists) describes what the FDA requires doctors to do if they
The first difference between children and adults starts with the smallest component of life: the cell. In his book The Cell, Geoffrey Cooper, a biology professor at Boston University, says that cells in children reproduce much faster than in adults to keep up with the children’s rapidly developing bodies. This is extremely important for the development of medicine for children because if a child were to get cancer, that cancer has a higher rate of advancement because of the fast-replicating nature of the cancer cells. Children also have small, fragile bodies that must be treated very delicately. In his article “An Overview of Anatomical Considerations of Infants and Children in the Adult World of Automobile Safety Design”, family medicine doctor Donald Haulke writes that the bones of children are more susceptible to breaking than adult bones because of their small diameter. When treating children for health problems like bone cancer, it’s important to have a treatment plan that takes childhood fragility into account. Just because a treatment plan works on the durable bodies of adults does not mean that the same process will work on the …show more content…
Clinicaltrials.gov, where all clinical trials must be registered, reports that from July 2005 to September 2010, only 5035 (7%) registered trials enrolled the pediatric population (Pasquali et al.). This shows how much of a shortage there is regarding pediatric clinical trials. Consequently, a shortage of trials means a shortage of treatment plans designed specifically for children, so doctors are forced to administer adult drugs. Dr. Tewodros Eguale, a research scientist and associate professor at Massachusetts College of Pharmacy and Health Sciences, says that if there is no accessible data suggesting a drug will work if used off-label, negative drug events become 54% more common (Esposito). Doctors are really only trying to help children, but there is no sufficient data backing up their desired treatment plan, and that makes it hard to properly treat the children. If pediatric clinical trials were more common, more data would be accessible to doctors, and less children would be likely to suffer the consequences of taking a drug not designed for them. Further enforcing the fact that not enough pediatric data is available to doctors, the article “Off-label Use of Drugs in Children” by the Committee on Drugs (a group of pediatric drug specialists) describes what the FDA requires doctors to do if they