Essay on Medical Ethics in Drug Trials

The Food and Drug Administration (FDA) is above the IRB, and the IRB follows the FDA regulations. Therefore IRB has the authority to monitor, approve, or disapprove research because they follow the FDA regulations. The IRB helps to make sure that patients are not just looked at as test subjects but as human beings.

The U.S. Food and Drug Administration (FDA) is responsible for protecting and promoting public health through regulating pharmaceutical drugs, biologics and medical devices in the context of granting approvals for marketing authorization, surveillance of the clinical trial study of the drug, and post-marketing surveillance of the medical product. Pharmaceutical companies seek FDA approval for a new drug to be marketed which entails a long process. This process starts with submitting an application known as an investigational new drug application (IND) to start clinical trials to enroll a group of patients believed to benefit from the investigational product, and to approve that the drug is safe and effective.

Clinical trials are essential for medical progress. Although new treatments are discovered through trials, participating in research is different from receiving treatment. Yet, some human subjects fail to comprehend the purpose of phase 1 clinical trials and believe that they will benefit from participating in the study. This failure to recognize potential harms is called therapeutic misconception (TM). To reduce TM, focusing on communication is crucial. Understanding the perception that subjects within these trials have, can inform whether or not researchers should change how they communicate with subjects. This essay will illuminate three possible ways to mitigate the risks associated with TM and place responsibility for mitigating these risks on institutional review boards

Before addressing the topic of drug trials, we first need to discuss concept of patient consent. Patient consent plays a major role in how medical professionals can treat their patients in today’s medical field. For a doctor or other medical professional to legally treat a patient they must first gain consent from the patient, this concept also applies to drug trials. There are two main forms

“Guinea pigging initially entered the mainstream American vocabulary in January 2008, when an article by that name was distributed in New Yorker Magazine. Guinea pigging alludes to healthy people (overwhelmingly poor, occasionally understudies) who partake in clinical medication trials for pay (Weitz, 2013).” Before, most members in medication trials were either therapeutic understudies or workers who at any rate mentally comprehended the risks they faced or persons battling with ailments who may profit by the medications they tried. In the course of recent years, be that as it may, as medication testing and improvement have exploded and have to a great extent moved from charitable to revenue driven operations, the need to rapidly discover expansive quantities of exploration subjects has prompted the boundless utilization of exploration subjects has steered towards the prevalent use of healthy subjects for pay in timely trials of medication.

As more experiments are being demanded, the expenses for the trials are rising. Adult RCT’s are much cheaper to carry out than pediatric RCT’s, which is why they’re often used to calculate child dosage amounts (Heger, 2010). The families of the tested children are given a substantial amount of money for their participation. This covers any cost that may come from the risk of harming the child and/or as an incentive. A significant amount of money also goes to pay for the manufacturing of the drugs that are used in the experiment. Money can be lost if an experiment if performed incorrectly. If a trial is not planned and executed perfectly, the money is used to fix those mistakes, as well as to provide for another trial. “A 2007 study found that net profits from drugs specifically tested in children ranged from over $500 million to losses of nearly $9 million, with drugs that were blockbusters in adults more likely to yield larger profits”(Heger, 2010). Incentives are also used to persuade parents for their child to participate and persuade companies to conduct research. Companies are usually reluctant to perform research because

In this paper, I will cover ethical issues within the pharmaceutical industry, present opinion on Direct-to-Consumer marketing by drug companies, determine the parties responsible for regulation of compounding pharmacies, PharmaCARE used U.S. law to protect its own intellectual property, summarize at least one current example of intellectual property theft, analyze the potential issues surrounding the death of John’s wife, and lastly present major arguments that John can claim as a whistleblower.

The Article that I read spoke about the Ethics of Drug testing and workers/students attitudes towards it. While depicting the attitudes about this topic they used a survey which examined six demographics: sex, age, political preference, job classification, years with the company, and functional work area/ major. It seems to me that the Authors are not really posing an argument in this Article. I feel that their goal was to demonstrate the way drug testing is received amongst workers / students and to express the financial burdens on society. The role players are as follows: Authors- Dr. Zafar. U Khan whom is an Associate professor of accounting in the College of Business at Eastern Michigan University, Dr. S.K. Chadwla whom is the Frank

Modern day medicine has been affected by progresses in science and innovation. These advances have broadened the specialist's expert capacities. Innovation progresses have likewise made present day restorative science mentally difficult. Medicine has now turned out to be more unpredictable and demanding. An example incorporates treatment, prehab, and recovery of a Tonsillectomy. However this is just a single side. There are many difficulties that cutting edge medical science still needs to confront.

Morality plays a huge role in the health care field. This principle of right and wrong conduct is noteworthy to specialists while assessing the benefits and troubles of medical procedures. One may find the progress of helpful advances hard to endure. For example, using a piece of vitro arrangement to pick babies for an impeccable inherited human cloning. If we screen an incipient organism for a tissue sort, we can then allow certain physical qualities for the newborn child. We can pick their eye shading, kind of learning, physicality, and capacity that could propose our babies regardless, consummate in a perfect world society. Inherited

For over 250 years, physicians have documented the progress of human experimentation. The practice of testing on humans has help develop a modern system of human testing known as clinical trials (Jenkins& Hubbard,1991). Previous work from the past has made huge improvements in medical future. The current work of clinical has given patients better medical treatments. While human experimentation has given much to modern research, it has sometimes failed to follow bioethics. The significance of human testing and history has lead to modern practice of Human drug trials.

While the effort of a scientific community in terms of the capital and time is precious, it is always a quintessential element to remember that innovation and discovery can march forward with the direct involvement of the human subjects. Though there are various debates about why a person might turn into a participant, a factual base to every trial is that there is always an impending risk for the subject. With this as the point of issue, there had still been horrific experiments in the scientific community on the human subjects that brought into picture the essence of ‘Ethics’ in the field of clinical trials.

While designing research and searching for subjects, medical workers and researchers have faced and still face profound ethical challenges. They have found that interests of knowledge and science do not always follow the same road as the interests of their subjects’ health (Mills and Morris 66). Obtaining full informed consent, balancing risks and benefits, maximizing subject autonomy, and developing results into treatment is complex and difficult. The government, review committees and researchers have also had tense interactions as oversight and transparency come up.

However the safety of the drug is taken by the sponsor during the phase I studies but during phase II, III, and IV Food and Drug Administration (FDA) must also ensure the safety of the medicament in humans for market approval.

The issue regarding this scenario is that the company is deliberately hiding information regarding the safety of the new drug. The drug had been researched and it was found that is produced minor side effects that could be detrimental to the users, which is a serious ethical problem.