Hypothetico-Deductive Modeling to Q&A

Americans have access to and benefit from one of the most technologically advanced pharmaceutical systems in the world. However, this system is also very strict and tedious. The system this paper will evaluate is the United States Food and Drug Administration (FDA), more specifically, the FDA’s Center for Drug Evaluation and Research (CDER). Although, having access to this system can be frustrating to those that are in the pharmaceutical development industry or those that have illnesses and need the best drugs available in order to cope with their symptoms.

1. Models are analogies that allow us to clarify hypotheses—proposed explanations of relationships between causes and effects. What roles do models play in testing hypotheses?

Misconception with equipoise will make the barrier between therapeutic and research null. Its goal in producing reliable and generalizable knowledge is coiled in with ethical difficulty. That’s why on an ethical standpoint, benefiting a collective group needs to be weighed with the rights of the participant patients in the clinical research. However, the goal of equipoise is beneficial since its main priority is extracting epistemic information from the randomized clinical trials. The useful information is needed since equipoise follows the principle of having “a state of genuine uncertainty.” This affects both theoretical and clinical. So, trials that are redundant can be marked out by taking equipoise into account since the trials have already been run where there is already certainty of the outcome. So, to detail what equipoise allows underneath the principle of “non-exploitation” is that there will be no exploitation of participants or patients with a needless trial that holds no useful outcome. Equipoise becomes a necessary condition in order for a trial to become ethical since trials must be reviewed to be deemed of value. But, there’s an underlying factor that equipoise’s uncertainty trials do not bring about and that is the health of the patients. Participant patients will undergo trials of uncertainty so there is a possibility that the patient may be harmed during the process. If the trial proceeds, then the health of the patients will be even more at risk, disregarded and exploited in order to grasp epistemic information. The moral principles between medical therapy and those that guide clinical research is different. Though, equipoise is valuable in a collective sense – it is exploitative of participant patients by failing to consider the balance with the subject and societal

Hypothesis is typically used in quantitative research only. Moreover, when a question poses an inquiry on the relationship between two variables, a hypothesis is a statement declarative in nature of the relationship between different variables (Pajares 2007). A researcher chooses whether to use a question or a hypothesis depending on the purpose of the research, its objectives, the methodology for the research and the preference of the audience to receive the research. A researcher must be able to interpret the final outcome with reference to the research questions or the hypothesis used (Pajares 2007). A research requires a minimum of two hypotheses namely a null and an alternative hypothesis.

In an experimental research, the use of a research question answers the thesis statement that enables one to research about a problem (Yin, 2013). From the experiment, the research question can be clearly stated as “which vaccine is more effective for preventing getting the flu”. In this case, the problem being researched about is the flu the possible solutions to this problem which the use of vaccines is being analyzed. The null hypothesis of this experiment states that there is no effective vaccine for preventing getting the flu while the alternative hypothesis states that there is an effective vaccine for preventing getting the flu.

The process used to pool the data together was clinical trial decision making. The main factors influencing this process consist of patient, provider, and treatment. Two studies specifically explored decision making by the patient. Education requirements impacted decision making since understanding the risks and benefits of clinical trials was the most important factor taken into consideration by the patient. Educational interventions were noted to have increased patient enrollment. (Biedrzycki, 2010).

The first step in testing hypotheses is to take the question at hand and turn it into a pair of theories that can be tested; the question is stated as a research hypothesis, and as a null hypothesis about the populations to be studied. The purpose behind this is to establish something to test the research hypothesis against, and essentially proving that the opposite of something is false is the same as proving that the thing is right. A prediction is made and then the polar opposite of the prediction is studied to ascertain its validity. If the null is proved wrong then the research hypothesis testing

Moreover, patients often have less knowledge than the prescriber does about the appropriateness of the drug, where it can be very misinforming for the consumer. Lastly, drug efficacy is a problem in all contexts. Since stakeholders are likely, less informed than manufacturers it causes both the consumer and prescriber to depend on the manufacturer for information of the effectiveness of the drug (Bennett, Quick, Velasquez, 2016).

Physicians must prove that there is no other comparable or satisfactory alternative in order to diagnose, monitor, or treat their patient’s condition or disease. They must also conclude that the potential risk of the product is not greater than the risk of the disease or condition (Expanded Access 1). The FDA must also determine that here have been enough tests done already to provide sufficient evidence as to the safety and effectiveness of the product and its use in the case (Expanded Access 1). In addition, the FDA must also be certain that by providing this product to patients outside of the clinical trial it will not interfere with the clinical trial, and the FDA acceptance of the drug (Expanded Access 1). Another requirement is that the company developing the pharmaceutical product, or the clinical investigator, submits a treatment plan (clinical protocol) for the patient, which must follow the FDA’s regulations for INDs (Investigational New Drug) or IDEs (Investigational Device Exemption Application), which describe the use of the investigational product (Expanded Access 1). Pharmaceutical companies must also submit a draft of the Data Development Plan (Expedited Access Pathway Program).

To better understand the issues associated with the prescription drug industry, it would first be best to understand their development and approval process. For a new drug to enter the market, it must first undergo a lengthy and often expensive research and development. Once a company submits an application for a new drug, it is their responsibility to provide the evidence showing its safety and effectiveness. Until they have undergone these criteria of guidelines and standards set in place, they will not receive FDA approval.

People wonder about the mindset of a scientist, and Barry’s use of rhetorical questions places readers in this psyche. The rhetorical questions exhibit a procedure for how the scientist will conduct their experiment and for what they research. In this instance, the scientist needs to figure out “if dynamite would destroy what one is looking for”. This is an imperative question to confirm their research will not be destroyed if they use dynamite. Also, determining if the methods used reveal anything is the day-to-day life of a scientist, such as “would analyzing the water after it passes over the rock reveal anything useful,” is important for scientists to consider. Verifying their research methods reveal useful data is another important element

The dependency of profits to promote sales to please shareholders and research and development of new products seem to be the mindset of the pharmaceutical industry. It is without question that the pharmaceutical companies only care about making a profit more than they do to help the people of the United States. Pharmaceutical companies and doctors that represent them are only acting in their own best interest; patients are the ones who are suffering the most. With that, new information being produced it is not always being fully disclosed in the fine print, or the other option to the drugs they take, this just only helps fuel business’s.

The author believes that biomedical research is the way of better understanding medicine and without randomized clinical trials the field of medicine will have insufficient information. He argues that randomized clinical trials are the most scientifically sound and ethically correct means of evaluating new therapies. The belief of a physician being unethical when running randomized clinical trials is rejected by this article because previous trials on patients can have a better outcome on future patients. This article stresses that randomized clinical trials must be carefully designed that has an intended purpose of gathering data to improve the wellbeing of patients. If the patient is to endure a clinical trial he/she must be properly informed of the risks of the trial and the health of the patient should be high priority. Overall this article explains the importance of randomized clinical trials and debunks the idea of randomized clinical trials as being unethical. This article uses a utilitarian point of view and gives reasons why these trials can be in the best interests for both the patient and society.

It is now accepted worldwide that before a drug is brought into routine use its efficacy, safety, and the balance between two need to be formally demonstrated. The efficacy of new drugs nowadays is almost invariably established with a technique known as ‘randomized controlled trial’.

Pharmaceutical companies should attempt to be as transparent as possible when marketing prescription drugs to the public. Their marketing efforts should not only convey the benefits of the prescription drug, but also easily convey the possible risks associated with the prescription drugs. Many patients may tend to think the benefits outweigh the potential risks of prescription drugs and may pressure their physician to prescribe it. Due to the way the prescription drug is marketed, the consumer may believe the