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Recommended: Ethics in research
Enter any drug store in the United States, and you are instantly surrounded by thousands of drugs. They vary in size, color, strength and price. Some are easily obtained off the counter, while pharmacists hold others under lock and key. Despite the vast assortment available, they all have one process in common. Clinical trials. Before we can take them for our headaches, hypertension and hypoglycemia they all undergo the rigorous process of clinical trials. However, these trials have often resulted in the exploitation of vulnerable populations all over the world. As with all trials involving human participants, the ethical implications of clinical trials are now facing greater scrutiny. Carl Elliot investigates the role of American participants in clinical trials in “Guinea-Pigging: Healthy human subjects for drug safety trials are in demand. But is it a living?” His article highlights a critical reason why trials have begun to move overseas. Several problems have arisen as a result of the globalization of clinical trials, and the medical community has started to take notice. In “Ethical and Scientific Implications of the Globalization of Clinical Research”, an article in the New England Journal of Medicine, Dr. Seth W. Glickman and his associates delve into the increasing trend of globalization and its consequences. Drs. Harold Shapiro and Eric M. Meslin perform the same level of scrutiny, but with a greater focus on the development of the trials, in “Ethical Issues in the Design and Conduct of Clinical Trials in Developing Countries.” Christopher Rowland of the Boston Globe presents the motivation for globalization in “Clinical Trials seen Shifting Overseas Tufts Study Cites lack of U.S. Subjects”. Finally Sandhya Srinivasan an... ... middle of paper ... ...panies in developing countries, none were trials of diseases such as tuberculosis that disproportionately affect the populations of these countries. In contrast, we found a variety of trials in developing countries for conditions such as allergic rhinitis and overactive bladder. (“Ethical and Scientific Implications of the Globalization of Clinical Research” 819) This is a result on the location of the pharmaceutical companies funding the trials. Generally these companies are based in wealthy western nations, and as a result, test medications for conditions and diseases that affect the western world. The participants are once again exploited since they obtain little to no benefit from participating in the trial. While it may seem like the problems associated with clinical trials are too large to overcome, with a few reforms everyone can benefit from the trials.
Dr. John Abramson’s book Overdosed America debunks the myths about the excellence of American medicine. Abramson backs up this claim by closely examining research about medicine, closely examining the unpublished details submitted by drug manufacturers to the FDA, and discovering that the unpublished data does not coincide with the claims made about the safety and effectiveness of commonly used medicines. Abramsons purpose is to point out the flaws of the pharmaceutical industry in order to warn the readers about the credibility of the drugs they are buying. Given the critical yet technical language of the book, Abramson is writing to an audience that may include academic physicians as well as those who want to learn about the corruption of the pharmaceutical industry.
Introduction During the process of research, professionals collect data or identifiable private information through intervention or interaction. While this is a vital part of the scientific and medical fields, every precaution must be taken by researchers to protect the participants' rights. Ethics, outlined by the Belmont report; requirements, described by the Department of Health and Human Services (DHHS); and regulations, laid out by the Food and Drug Administration (FDA) are verified by an Institutional Review Board (IRB). This procedure ensures that all human rights are safeguarded during the entire research process. The Institutional Review Board The IRB is an administrative body which has been established to make sure research participants' rights are protected.
Although writing a prescription may be an easy way to put a bandaid on a problem, people tend to forget that medication can’t be responsible for curing our nation. Slowly we are becoming a country where pills are handed out like candy, causing a severe series of negative effects and downfalls. Ray Bradbury, the author of the award winning novel Fahrenheit 451, is definitely in agreement. In 1951, when the novel was written, Bradbury was able to make the prediction that the innocent use of medication would soon turn into an extreme drug epidemic, and unfortunately he wasn’t wrong. The overuse of drugs in the United States, such as mental illness medication
The implementation of evidence-based programs is generally quite new in the field of medicine, and it is even more recent in the social sciences field. One point of interest in the development towards evidence-based programs was the foundation of the Food and Drug Administration that is in charge of testing the security and safety of medicinal treatments (Leff, Conley, & Hennessey, 2006). Another point of interest was in the utilization of randomized control studies. It was in 1948 that the first study occurred – examining the adequacy of streptomycin in treating tuberculosis. By the 1960s the quantity of randomized control experiments reached into the hundreds, and in the last ten (10) years there are tens of thousands happening each day (Dodge, 2006). In the field of psychology, which does not have a legislative body inspecting the adequacy of treatments, it is the obligation of those in the field to examine effective and compelling programs. It truly was not until the 1990s that this concept started to expand. The Alcohol, Drug Abuse and Mental Health Reorganization Act of 1992 assisted with the creation of the Substance Abuse and Mental Health Services Administration (SAMHSA), whose part was to help in disseminating research and viable programs/services in regards to issue practices. In 1999, the American Psychological
When the treatment can be found inside and outside of the trial, then no consent is needed. Since they cannot anticipate how the drug will react in the trial and preform unsatisfactory results, they still need the patient consent. A treatment cannot have more risks than an alternative. The treatments in the trial must be balanced to achieve the most precise data. If this is not the case then the patients might choose one treatment over another just because of the effects of treatment, indirect effects of treatment, or bias nature of the patient (Truog et al. 1999).
In the business of drug production over the years, there have been astronomical gains in the technology of pharmaceutical drugs. More and more drugs are being made for diseases and viruses each day, and there are many more drugs still undergoing research and testing. These "miracle" drugs are expensive, however, and many Americans cannot afford these prices.
I do believe that every person life is meaningful and precise no matter what they are endured in certain situation in life; unfortunately, Dr. Michelle Hoover does not seem to understand that. She is a staff member in a health care institution who work with patients from the range age 40 to 75-year-old, and take care of them when their physician is unavailable. These patients suffer all type of diseases, such as, high blood pressure, depression, diabetes and cancer. However, she thought an anti-depressant drug that is in Phase III randomized also in clinical trials can help these patients because the owner of the company will give her 3,000 dollars for each female patients she is enrolled in the study. In fact, me personally I do not agree in such untrustworthy experiment that first of all can cause harm through those
Per capita spending on prescription drugs in America is far greater than any other country. Kesselheim goes on to say that this is a natural result of America’s free market approach to healthcare resulting in monopolies. These healthcare monopolies are not held accountable for their high drug prices. The claims that these costs can be justified through research and development is rubbish, according to
When doing any studies with human subjects, “the safest and most reasonable position is that people everywhere are likely to respond similarly to the same treatment” (300). With third world countries, Angell states there are dissimilarities between population, but that cannot be anticipated. The local of standard care should not be different, the best treatment and care should always be given regardless of where the study takes place and who the subjects are. As clinical trial studies are becoming more popular, researchers need to understand the same protection goes to the people rather they are aboard or at home. Studies done in third world countries are unethical because they cannot afford the same effective treatment.
Due to patents, Pfizer and other companies in the pharmaceutical industry are not always competing in a monopolist’s competition. When a business has a patent they are the only manufacturer who can produce the product until the product expires, so it is clear that the firm can act as a monopoly while in control of the patent. As a monopolistic company, the company has market power, giving it the capability to adjust the market price of a good. The main goal for a monopolist and business owner is to maximize their profits, however, there are rules they have to abide by. The monopolistic companies still have to keep up with the market demand curve. The point at which they decide to produce will rest on their own acidities of revenue, risk and effort. The company also needs to know the price elasticity of the curve: the greater the price elasticity, the more a company such as Pfizer will struggle to establish high prices and a high volume.
1. Capp, Marshall B. "Ethical and Legal Issues in Research Involving Human Subjects: Do You Want a Piece of Me? -- Kapp 59 (4): 335 -- Journal of Clinical Pathology." BMJ Journals. J Clin Pathol, 18 Jan. 2006. Web. 11 Feb. 2012.
When a person seeks medical attention they go with the hope that their personal rights will not be violated with the belief that doctors will uphold their personal standards. Unfortunately, this is not always so for people who visit the hospital. There are documented cases in United States history involving African Americans being experimented on for the greater good without their knowledge or consent, and some of the most heinous cases involve doctors injecting their study groups with life threatening diseases. What happens when good science goes bad and who has the right to relegate the status of another human being as less than? In this research paper we will examine a clinical testing case study featuring the violation and exploitation
In recent years’ health reform has been a driving force in the United States political system. If you watch the news you will undoughtabley hear how citizens, the government, or the economy is or might be effected by some sort of change in medical regulation. One of these hot topic issues is the cost of prescription drugs. Every major drug market besides the United States regulates the price of drugs in some way (Abbott and Vernon). By the United states not doing so many believes it opens consumers up to be exploited by large pharmaceuticals companies. Other believe regulating drug prices limits investment, innovation, and competition in the pharmaceutical industry. In many ways both views are correct yet the later may have more long term lasting
Looking beyond the Nuremberg Code and applying it to modern medical research ethics, there are many challenges that it poses. Many have argued that the Code tries to provide for all unforeseen events, which restricts the researcher by requiring him to anticipate every situation, demanding the impossible. The most important contribution of the Code is the first principle, which says that voluntary consent of the human subject is absolutely essential. The subject involved should have legal capacity to give consent, should have free power of choice, as well as sufficient knowledge and comprehension of the experiment. This restricts that populations upon which some experiment may be conducted, since many do not have “legal capacity”. For instance, studies of mental illness and children’s diseases have been curtailed because neither of these populations has the legal capacity to give consent. Another group of people, prisoners, are never really able to give voluntary consent since they might be enticed by financial rewards, special treatment, and the hope of early release in exchange for participating in the human experimentation projects. British biostatitcian Sir Austin Bradford Hill also questioned whether it was important to inform a research subject who was receiving a placebo since it does...
Miller, F. (2003). Therapeutic Misconception in the Ethics of Clinical Trials,. The Hastings Center Report.