Premium Essay

Are Controlled Clinical Trials Really Ethical?

In:

Submitted By JosieWilliams
Words 2973
Pages 12
Are Controlled Clinical Trials Really Ethical?
Case Study In 2009, two cousins, Thomas and Brandon were diagnosed with the same type of deadly skin cancer within a 2 month time frame of each other. To date, here is no cure for skin cancer and once diagnosed the average life expectancy is approximately 8 months. Current standard of care treatments are aimed at shrinking the tumors and prolonging life. Unfortunately, these standard of care treatments only work in a very small percentage of patients and are very toxic with terrible side effects. Thomas learned of a new Phase 3 clinical research trial sponsored by Roche with an unapproved yet promising drug. His doctor explained that in earlier trials, a majority of volunteer patients who took the wonder drug had seen a drastic reduction in the size of their tumors with very few side effects. The only way ill patients can get the drug is by participating in this trial. The trial is a randomized controlled trial (RCT) which means half of the volunteers will get the experimental drug while the other half will be treated with another standard of care treatment. The purpose of the standard or control arm is to allow researchers to compare the long term effects of the new drug to that of the current standard treatment and determine whether it actually shrinks tumors and prolong remissions. Participants have a 50/50 chance of being placed in either arm of the study. Arm assignments are random and cannot be changed. With limited options, Thomas signed up for the trial. He was randomized to the wonder drug arm and after 2 months saw his tumors shrink. Thrilled with these results, he urged Brandon to sign up for the trial as well which he did. By luck of the draw, Brandon is assigned to the standard of care treatment arm. During treatment, Brandon’s tumors continued to grow and he was in excruciating of pain. Tragically, he

Similar Documents

Premium Essay

Business and Management

...solution to a particular problem is. A hypothesis is an assumption that we will use the next step, experimentation to determine whether or not the hypothesis is true. An experiment is simply the tests that are done to prove or disprove a particular hypothesis. One of the main ways scientist experiment with their hypotheses is with research studies. If after experimentation research and experiments can’t prove your hypothesis, you both modify the hypothesis and restart experiments and research studies or you can reject the hypothesis and start over from the very beginning. One of the best ways of proving your hypothesis is through various types of research studies. A few different research studies are epidemiology studies and also clinical trials. According to Clinicalresearch.edu, Epidemiology is “the study of distribution and determents of health-related states or events in specified populations.” Also considered observational studies, Epidemiology analyze things...

Words: 910 - Pages: 4

Free Essay

Airborne Ethical Practices?

...Legendre Business Ethics Prof. Martin Wednesday, October 16, 2013 I. Case Overview Dietary Supplement Industry The growing dietary supplement industry, which includes the hundreds of weight loss and immune support supplements on the market, grosses approximately $20 billion annually (Burke). As established by the Dietary Supplement and Health and Education Act of 1994 (DSHEA), these supplements are not required to undergo testing or receive approvals from the Food and Drug Administration (FDA). Instead, companies must notify the FDA of all new products and ensure that they are safe for consumers. The Federal Trade Commission (FTC) does not prohibit dietary supplements from claiming health benefits but rather requires thorough clinical trials to support such statements. In 2012, the Department of Health and Human Services investigated 127 supplements and found that 20 percent of them were illegally labeled and lacked the necessary scientific evidence to support the proclaimed health benefits (Ibid). Many of these illegal labels included confirmatory statements on curing or preventing diseases such as diabetes or cancer. The report also revealed that 7 percent of the surveyed supplements did not have the mandatory disclaimer stating that the FDA had not evaluated statements on the label for validity (Ibid). Airborne Case Airborne, a popular vitamin and herbal supplement known for its controversy over preventing the common cold was invented by Victoria Knight-McDowell. McDowell...

Words: 3333 - Pages: 14

Free Essay

Schizophrenia

...for people that suffers with a major mental illness. People with schizophrenia often have problems fulfilling a task in the general population, at work, at school, and in relationships leaving an individual not wanting to communicate with other people and frightened. Schizophrenia suffers will live with it the rest of their life, it cannot be cured but treatments are available and controllable with proper and advance treatments. Contrary to popular belief, schizophrenia is not a split or multiple personality. Schizophrenia is a psychosis, a type of mental illness in which a person cannot tell what is real from what is imagined. In writing this paper on Schizophrenia I will show how popular belief, has an antithesis of what is really Schizophrenia? Is it really a split or multiple personality or a psychosis considered by popular belief? I will introduce why Schizophrenia was chosen as my research topic, and the field of studies of the process methods used to regulate and control schizophrenia as a disease. Schizophrenia has been considered as one of many chronic and disabling conditions for people that suffers with a major mental illness.The article and...

Words: 3391 - Pages: 14

Premium Essay

Healthcare Ethics

...poorly controlled by a plethora of medications. Leo works for a small printing business, a job he enjoys, but one that makes it difficult for him to make ends meet. With only six employees, the company’s owner cannot afford to offer health insurance. Leo’s annual salary of $30,000 allows him to purchase only the most basic of health plans, one that does not include coverage for prescription medications. Leo frequently must decide between medications and food, often opting for cheap junk food that is neither nutritious for his young family nor appropriate for a diabetic diet. Leo has recently applied for and been offered several other jobs, but at a lower salary and with no health insurance coverage. Recently, Leo’s diabetes has worsened. He has developed a serious infection that has led to lost wages and, far worse, the loss of his right leg below the knee. Leo is weighing his options. He has heard about a new clinical research trial open to insulin-dependent diabetics that pays $100 a week to research subjects. He has also been quite depressed and begun to wonder if his children might not be better off without him. He has several life insurance policies that would pay off generously if something were to happen to him, and he has broached the subject of assisted suicide with his long-time physician. Is there a way, he asks his physician, to have his death look like it was from natural causes so his children could collect on the policy? CHAPTER QUESTIONS 1. What ethical responsibilities...

Words: 9363 - Pages: 38

Free Essay

Competence

...Julian Jane Atim, MBChB, MPH Uganda Health Marketing Group (UHMG) Stephanie Cantu Harvard Medical School Jonelle Wright, PhD, RN University of Miami Introduction This module consists of four (4) sections. After completing the training, you will take a short quiz on the training content. After completing the quiz, we ask you to answer a few optional questions to give your view of this training module. Learning Objectives By the end of this module, you should be able to: Describe the concept of Cultural Competence in Research Explain the importance of Cultural Competence in Research Describe ways to enhance the engagement of diverse populations and communities in research Identify cultural competence challenges faced by researchers when working with culturally diverse populations Cultural Competence in Research Culture is fundamental to everyone's perceived identity. It is a mix of one's values, beliefs, standards, norms, behaviors, language, communication styles, and thinking patterns.[1] Cultural competence refers to understanding the importance of social and cultural influence on the beliefs and behaviors of the patient, student, colleague or client.[2] Cultural competence in health care describes the ability of systems and health care professionals to provide high quality care to patients with diverse backgrounds, values, beliefs, and behaviors, including communicating effectively and tailoring delivery to meet patients' social, cultural and linguistic...

Words: 3737 - Pages: 15

Free Essay

Tuskagee Study

...Elizabeth Reynolds Writing 5 Essay One Assignment: The Tuskegee Study Free at Last: the Center for Disease Control Ends and Ethical Research Practices Begin During the forty year Tuskegee Study, the government overstepped its duties and infringed on innocent African American lives. Researchers in Macon County, Alabama started this study in 1932 in order to examine the effects of untreated syphilis in African American men. The study began with 399 subjects with the disease and 201 without it; by the time the research was halted in 1972, over one hundred of the men had died (Jones 2). One government organization involved in this experimentation acted particularly irrationally: the Center for Disease Control (CDC). The CDC knew exactly what was going on with the Tuskegee Experiment and understood that the subjects were being denied treatment. However, the CDC never questioned the morality of their experiment. Furthermore, the director at the time, Dr. David Sencer, was an advocate for continuing the research. Even when Dr. Irwin J. Schatz, staff member of the Henry Ford Hospital, first sent his letter to the CDC objecting to the Tuskegee study in 1964, Dr. Sencer allowed the CDC to set the letter aside and pretend it did not exist. When another opponent of the study, Peter Buxton, started his 1965 investigation of the study, Sencer’s first concern was not that the CDC was acting unethically, but that the CDC would get bad press (Jones 190). Clearly the CDC was not actually...

Words: 2282 - Pages: 10

Free Essay

Negligence, Gross Negligence or Malpractice

...practice, and failure to provide care that any other reasonable prudent nurse would provide. The Elements that a plaintiff must prove to win their negligence claim include breach of duty, causation, and damages (Weiler, 1995). If they cannot prove there was a breach in all three of these things, then the plaintiff will lose the case. Gross Negligence, is negligence on a grand scale. It borders reckless behaviors and culpability. It is most simply explained in terms of degree of negligence, or the severity of the negligence is worse than simple or ordinary negligence. Gross negligence can be very subjective and is used in extreme cases that might have ended with manslaughter charges or something of the like. Could the event or act have been controlled by the practitioner? If the answer is yes, then it is probably neglect. If the act was purposeful and the practitioner understood the nature of their actions, conduct, and the ramifications, if they were reckless in their actions, and if the results were substantial then gross negligence would certainly be a consideration. Documentation is monumental in cases involving negligence. Generally, whatever a nurse or staff writes is believed, and if it wasn’t written down it didn’t happen. As a rule who, what, how,...

Words: 1320 - Pages: 6

Premium Essay

Nutrobalance Pm587

...beginning of time. In 4000 BC the Egyptians applied bright green paste made from copper minerals to their face to provide color and definition. They also painted on eyebrows with cream that came from sheep’s fat, lead and soot. Fast forward to the present time. In the 1970’s “certain ingredients were banned from use in cosmetics to protect endangered species, and other species currently used as “lab rats” by some cosmetics manufacturers.” (Cosmetic Discounter, 2004) The sale of cosmetics within the US market has increased from 3.34 billion dollars in 2000 to 5.35 billion dollars in 2005. Some studies also estimate that this market will increase to reach 8 billion dollars in 2010 and further to 11.85 billion dollars in 2015 and what is really driving growth is innovation. This means that products are being formulated with increasing amounts of highly developed active ingredients, such as anti-wrinkle and firming agents. The contra of this innovation is focused on the environmental issues: The unfortunate practice of many cosmetic companies trialing their products on animals in horrible ways, some contents like dibutyl phthalate, or DBP, a chemical linked to cancer in animals and other chemicals commonly found in cosmetics include acrylamide, formaldehyde and ethylene oxide - all listed by EPA as carcinogens. L’Oreal is the global leader in cosmetics. They have 25 brands that are made up of hair care, colorants, skincare, make up, and fragrances. (L’Oreal, 2007) Company...

Words: 2352 - Pages: 10

Premium Essay

Dalkon Shield Case Study Paper

...The Dalkon Shield Case Study Report Abstract The case study involving A.H. Robins Company will discuss blatant lack of due diligence of the product Dalkon Shield. Ignoring appropriate measures to ensure safety or the product along with misleading aggressive promotional strategies and literature show the malicious intent of the company for short-term profits, despite the fatal and devastating impacts on the public. The Dalkon Shield Case Study Report Unethical Practices As inventors, Davis and Lerner, at first were following protocol by developing, testing, distributing, and refining their product to a small controlled portion of the public with good faith and due diligence along with documenting their studies and recording accurate results. The point Dalkon Shield’s life where unethical practices first become apparent was during the acquisition of A.H. Robins Company of the product from Dalkon Company. The first contributing factor was the financial motivations when Dalkon Company realized that their product needed corporate distribution especially since they lacked the sale team in the organization. A.H Robins Company just did not acquire the product, but put the two inventors became consultants for the company as well. This makes a biased unilateral perspective for pushing financial opportunity gains over appropriate procedural practices when offering this particular new product. The second contributory factor is utilization of a legal loophole that the IUD did...

Words: 2522 - Pages: 11

Premium Essay

Legal and Ethical Considerations in Marketing

...Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property Amanda Terry Professor: Dr. Michael Hanners LEG 500- Law, Ethics, and Corporate Governance March 12, 2015 Introduction John, a former research employee at PharmaCare pharmaceuticals, asked my law firm to represent him as a client. He expressed his concerns about his involvement with PharmaCare’s top-selling drug AD23. John and his team of pharmacists discovered that the drug could slow down the progression of Alzheimer’s. Therefore, his team reformulating the drug to maximize the effect of the drug without the approval from Federal and Drug Administration. In this paper, I will evaluate three ethical issues relating to marketing and advertising, intellectual property, and regulation of product safety, as well as, analyze whether PharmaCare violated any of the issues in questions. I will argue the pros and cons of Direct-to-Consumer (DTC) Marketing by drug companies. I will determine which parties were responsible for regulating compounding pharmacies under the current regulatory scheme. Also, the actions that either party, or the FDA could/ should have taken in this scenario; whether PharmaCare could face legal exposure surrounding its practices. I will analyze whether or not the PharmaCare used U.S. Law to protect its own intellectual property, and if John (the client) has any claim of being the true “inventor” of AD23. I will present at least three ways the company could...

Words: 3335 - Pages: 14

Premium Essay

Argumentative Essay On Designer Babies

...For example, while the babies are in the in vitro stage, their genes can be changes so that the could have blonde hair, really tall, or have green eyes. That doesn’t sound too bad. However, those are just the physical characteristics. Agar additionally explains how babies can be born with or without certain disease causing genes. This means that if the genome is altered correctly, the child won’t be susceptible to diseases such as Alzheimer's or dementia. This process has been tested on mice and plants. In plants, it is very effective and helpful to make sure the crop grows fast and has the maximum amount of product. In mice, there have also been excellent outcomes, however there are evidence of side effects. “There is evidence for such effects on doogie mice, which seem not only to have improved powers of learning and memory, but also to have a greater sensitivity...

Words: 1720 - Pages: 7

Premium Essay

Fraternity

...POSTPARTUM DEPRESSION: LITERATURE REVIEW OF RISK FACTORS AND INTERVENTIONS Donna E. Stewart, MD, FRCPC E. Robertson, M.Phil, PhD Cindy-Lee Dennis, RN, PhD Sherry L. Grace, MA, PhD Tamara Wallington, MA, MD, FRCPC ©University Health Network Women’s Health Program 2003 Prepared for: Toronto Public Health October 2003 Women’s Health Program Financial assistance by Health Canada Toronto Public Health Advisory Committee: Jan Fordham, Manager, Planning & Policy – Family Health Juanita Hogg-Devine, Family Health Manager Tobie Mathew, Health Promotion Consultant – Early Child Development Project Karen Wade, Clinical Nurse Specialist, Planning & Policy – Family Health Mary Lou Walker, Family Health Manager Karen Whitworth, Mental Health Manager Copyright: Copyright of this document is owned by University Health Network Women’s Health Program. The document has been reproduced for purposes of disseminating information to health and social service providers, as well as for teaching purposes. Citation: The following citation should be used when referring to the entire document. Specific chapter citations are noted at the beginning of each chapter. Stewart, D.E., Robertson, E., Dennis, C-L., Grace, S.L., & Wallington, T. (2003). Postpartum depression: Literature review of risk factors and interventions. POSTPARTUM DEPRESSION: LITERATURE REVIEW OF RISK FACTORS AND INTERVENTIONS Table of Contents EXECUTIVE SUMMARY 2 OVERALL METHODOLOGICAL FRAMEWORK 5 CHAPTER 1: RISK FACTORS FOR...

Words: 108533 - Pages: 435

Premium Essay

Unit 22, P3

...BTEC National Diploma in Health and Social Care Unit 22: Research Methodology Task 1: P3 Introduction: In this assignment I am going to be creating a table comparing the different research methodologies in health and social care. Research methods are “the various specific tools or ways data can be collected and analysed, e.g. a questionnaire, interview, etc.” (Neville, C, 2007). Methods | Advantages | Disadvantages | Validity | Questionnaires are “a series of questions asked to individuals to obtain statistically useful information about a given topic” (Bryant, L, 2014). There are different types of questionnaires that include face to face, phone, post and online. | -Practical-Large amount of information from a large amount of people can be collected in a cost effective way.-The results can be easily quantified.-It can be carried out by the researcher or any number of people without affecting its validity and reliability.-The results can be analysed more ‘scientifically’ and objectively than other forms of research (University of Surrey, 2014). | -Format makes it difficult to for the researcher to examine complex issues and opinions.-The person which the questionnaire has been send to may not actually fill it.-If the researcher is not present it may be hard to tell whether the participant has understood the question.-The meaning of the questions may be different to the each participant.-In postal questionnaires, the number of them being returned tends to be very low...

Words: 2201 - Pages: 9

Premium Essay

Inventory

...and Medicine, London SW7 2BY, UK Abstract Supply chain optimisation is now a major research theme in process operations and management. A great deal of research has been undertaken on facility location and design, inventory and distribution planning, capacity and production planning and detailed scheduling. Only a small proportion of this work directly addresses the issues faced in the pharmaceutical sector. On the other hand, this sector is very much ready for and in need of sophisticated supply chain optimisation techniques. At the supply chain design stage, a particular problem faced by this industry is the need to balance future capacity with anticipated demands in the face of the very significant uncertainty that arises out of clinical trials and competitor activity. Efficient capacity utilisation plans and robust infrastructure investment decisions will be important as regulatory pressures increase and margins are eroded. The ability to locate nodes of the supply chain in tax havens and optimise trading and transfer price structures results in interesting degrees of freedom in the supply chain design problem. Prior even to capacity planning comes the problem of pipeline and testing planning, where the selection of products for development and the scheduling of the development tasks requires a careful management of risk and potential rewards. At the operation stage, it is often difficult to ensure responsiveness. Most pharmaceutical products involve primary active ingredient...

Words: 10158 - Pages: 41

Premium Essay

German

...make it unavailable for public hospitals, and those who are poor may not be able to benefit from this technology, but this transfer from traditional methods in medicine must happen, as technology affected all aspects of our lives. Robot might sound as a very modern scientific invention, but it is not as the first time “robot” was introduced and coined was in 1921, in a play written by the Czech writer Karel Capek, and since then robots took a place in many aspects of our lives, they also take place in dangerous and highly precise tasks, such as aviation, and here we will discuss the medical usage of robots, starting from the history, to political and economic questions, also Psychological considerations and sociological effects , and the ethical considerations. The first laparoscopic cholecystectomy using robots was performed in 1987, since then, the procedures performed in similar ways have grown “at a pace consistent with improvements in technology and the technical skill of surgeons.” (Surg) this surgery is known as minimally invasive as incisions are smaller, there is less...

Words: 4024 - Pages: 17