The achievements in the field of healthcare and medicine cannot be ignored. Many helpful discoveries are being made to advance the possibility of treating such serious health problems and genetic disorders like Down’s syndrome, Huntington’s disease, and diabetes. Representatives of the US Food and Drug Administration (FDA) aim to ensure the safety and effectiveness of drugs marketed for a particular country (U.S Food and Drug Administration, 2018). The Center for Drug Evaluation and Research (CDER) is the primary center for taking responsibility for new pharmaceutical discoveries. Diabetes is a disorder that plagues millions of people around the globe. Though genetics is a central risk factor for developing diabetes, such aspects as the environment and the chosen lifestyle have to be considered. This paper aims to discuss FDA recommendations, the role of money in health care, and the significance of family involvement in diagnosing and treating diabetes along with the laboratory studies and tests currently available and new perspectives that can improve public understanding of the disease.
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Discussion of the Guidelines and Reasons Behind the FDA Regulations for Introducing New Pharmaceutical Agents (Policy)
The FDA supports the idea of innovation and progress in the production of new biological products. The CDER tests discoveries for new opportunities for people to be treated, to relieve pain, and to avoid harmful genetic mutations (Lagassé et al., 2017). The process of introducing new drugs consists of several stages. First, it is necessary to classify new molecular entities in terms of FDA goals (administrative or therapeutic). This decision helps determine if a chosen drug is innovative in terms of its chemical composition. Second, the organization checks all moieties as parts of these drugs in terms of their chemical composition and determines if some of them have already been approved (U.S Food and Drug Administration, 2018). To complete this step, it is necessary to evaluate the entire drug development process, starting from laboratory discoveries and ending with safety monitoring. Finally, the Public Health Service Act must be complied with to make sure that all federal standards have been followed. Recently introduced drugs include opdivo to deal with lung and liver problems and glucagon to counter the action of insulin.
Discussion of the Role that Money and Grants Play in Scientific Advances and the Economics of Health Care
The question about the worth of new therapeutic agents and their cost troubles many people. During the last several years, the number of Americans with diabetes has dramatically increased from 25 million to 29 million (Lopez, Macomson, Ektare, Patel, & Botteman, 2015). Mittermayer et al. (2015) state that the total estimated costs of diabetes diagnosis increased up to $245 billion, with $176 billion to be spent on medical costs and $69 billion reflecting reduced productivity. The investigations of Conti and Rosenthal (2016) show that the government can save about $15 billion annually by conducting negotiations with modern pharmaceutical companies. This step would help protect patients’ rights and encourage lawmakers to develop special grant systems to increase the quality and quantity of production. Still, these numbers attest to the role of money in scientific research and the fact that it is difficult to decrease the price due to the expenses of experimental studies, including purchasing of equipment, acquisition, travels, and communication.
Discussion of the Role and Involvement of Family Plays in Health Care Decisions
Every health care decision should be based on several factors. However, the role of family and the possibility of being involved in the treatment and healing processes remain an urgent topic for discussion. First of all, family caregivers can provide patients with the required emotional and practical support (Itzhaki, Hildesheimer, Barnoy, & Katz, 2016). The second important issue regarding family involvement is the possibility to improve decision making and the evaluation of a patient’s condition, available resources, and costs from several points of view. Finally, family members can make judgments about the quality and outcomes of medical treatments about personal values (Itzhaki et al., 2016). Sometimes, patients have to deal with complex medical information and make decisions using their background knowledge and experience. If they do not have enough confidence and awareness, family involvement can become a helpful alternative. Common interests, family history, and past medical problems may be properly described and explained by several people to make sure health care decisions do not harm patients.
Discussion of the Disease, Its Prevalence, and Its Incidence
Diabetes is a well-known disease around the world because even if a person does not have it, he or she has probably heard about it and its effects on the quality of life. It is a heterogeneous disease that may be of two types, 1 – insulin-dependent (T1D) and 2 – non-insulin-dependent (T2D) (Dooley et al., 2016). The exact etiology of T1D and T2D is currently studied because researchers and practitioners cannot state clearly what factors or triggers can directly cause the development of diabetes in persons. It is found that T1D develops as a result of the autoimmune response of a human organism against certain beta cells in the pancreas. As a result of this reaction, pancreatic beta cells cannot contribute to producing insulin. The development of T1D leads to the situation when a person’s pancreas cannot produce the required insulin anymore. This specific hormone is responsible for regulating sugar levels in the organism (Dooley et al., 2016). This form of insulin deficiency can be caused by genetic aspects and such environmental factors as viruses, but actual causes are unknown. Moreover, T1D is mostly diagnosed in childhood.
On the contrary, the development of T2D can be provoked by a person’s lifestyle and such specific factors like overweight and obesity. However, this type of diabetes can also be hereditary in association with a person’s predisposition to this disease referring to the family medical history. This type of diabetes is usually observed in adults, and it means the decrease in the production of insulin in the pancreas because of certain metabolic changes in the organism that are caused by overweight and obesity (Dooley et al., 2016; Nussbaum, McInnes, & Willard, 2007). As a result, insulin resistance develops in this case while leading to more acute metabolic changes and negative alterations in the work of blood vessels, nerves, and kidneys.
T2D includes about 90% of all diabetes cases, and an increased prevalence of this disorder is observed among Native Americans aged between 35 and 40 years (Nussbaum et al., 2007). The reasons for its prevalence remain unknown. Despite numerous attempts to investigate the features of diabetes, its molecular and genetic bases are poorly defined in the current state of research (Nussbaum et al., 2007). Though diabetes may have different causes, two factors play a crucial role in its development. On the one hand, a patient may inherit a predisposition. On the other hand, genes are not enough to trigger this disease. The environment’s effect should also be considered.
The clinical convergence of diabetes needs to be investigated. T1D and T2D patients demonstrate a progressive decline in beta cells (Dooley et al., 2016). A complex genetic landscape is also observed in the chosen group of patients, with several genes of GLIS3 and EIF2AK3 being recognized (Dooley et al., 2016). From this perspective, these genes cause defects in insulin production and result in hyperglycemia and poor protein and fat metabolism. Thus, the pathogenesis and epistemology of diabetes determine its prevalence and incidence, leading to an increased incidence among children and young adults while depending on the type of diabetes.
Discussion of the Possible Laboratory Testing
The diagnosis, screening, and management of diabetes have to be properly developed in a care plan offered to patients. Patients can check their condition using several laboratory tests, including fasting plasma glucose (FPG), hemoglobin A1C, and random plasma glucose (Dooley et al., 2016). For example, the FPG test can be offered to both adult and child patients. The main requirement is to avoid food intake at least eight hours before the test. It indicates the level of glucose in the blood and can determine prediabetic conditions. The A1C test is focused on the level of hemoglobin in the blood and the presence or absence of oxygen-carrying proteins. The unusual feature of this laboratory test is that patients with specific blood problems cannot obtain clear results. Finally, the random plasma glucose test can be taken by people who are already aware of diabetes as their diagnosis or who observe evident symptoms of the disease.
However, the list of laboratory testing options can be enlarged. For example, Dooley et al. (2016) suggest flow cytometry to detect antigens and evaluate platelet membrane activity. This test can be used to identify the most appropriate drugs approved by the FDA. Metformin, sulfonylureas, DPP4 inhibitors like sitagliptin, and thiazolidinediones can be used (Mittermayer et al., 2015). Still, it is difficult to predict all possible agents and choose effective drug classes for all patients without considering their characteristics and outside factors. Therefore, the investigation of diabetes needs to be continued under laboratory conditions to improve the patient’s quality of life.
In general, diabetes is a condition that has been thoroughly investigated by the FDA and other worldwide organizations. A genetic predisposition is not the only risk factor that should be mentioned in this discussion. The role of the environment has to be emphasized. Therefore, such issues as family involvement, including emotional support and effective decision making, and government participation, including grants and funding alternatives, should be improved and promoted in all countries.
Conti, R. M., & Rosenthal, M. B. (2016). Pharmaceutical policy reform – Balancing affordability with incentives for innovation. New England Journal of Medicine, 374(8), 703-706.
Dooley, J., Tian, L., Schonefeldt, S., Delghingaro-Augusto, V., Garcia-Perez, J. E., Pasciuto, E.,… Liston, A. (2016). Genetic predisposition for beta cell fragility underlies type 1 and type 2 diabetes. Nature Genetics, 48(5), 519-527.
Itzhaki, M., Hildesheimer, G., Barnoy, S., & Katz, M. (2016). Family involvement in medical decision-making: Perceptions of nursing and psychology students. Nurse Education Today, 40, 181-187
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Lagassé, H. D., Alexaki, A., Simhadri, V. L., Katagiri, N. H., Jankowski, W., Sauna, Z. E., & Kimchi-Sarfaty, C. (2017). Recent advances in (therapeutic protein) drug development. F1000Research, 6, 113-130. doi:10.12688/f1000research.9970
Lopez, J. M., Macomson, B., Ektare, V., Patel, D., & Botteman, M. (2015). Evaluating drug cost per response with SGLT2 inhibitors in patients with type 2 diabetes mellitus. American Health & Drug Benefits, 8(6), 309-318.
Mittermayer, F., Caveney, E., de Oliveira, C., Gourgiotis, L., Puri, M., Tai, L. J., & Turner, J. R. (2015). Addressing unmet medical needs in type 2 diabetes: A narrative review of drugs under development. Current Diabetes Reviews, 11(1), 17-31.
Nussbaum, R. L., McInnes, R. R., & Willard, H.F. (2007). Thompson & Thompson genetics in medicine (6th ed.). Philadelphia, PA: Saunders Elsevier.
U.S Food and Drug Administration. (2018). New drugs at FDA: CDER’s new molecular entities and new therapeutic biological products. Web.