A Lethal Prescription The Trouble with Zorlite, by Julian Friedland, Ph.D., is an excellent case study to illustrate and assess moral conflict. The case describes a situation where the U.S. Food and Drug Administration (FDA) failed to appropriately protect individuals by approving Zorlite, a prescription drug for intestinal irregularly, shown to increase heart attack risk by a multiple of 5. Tom Green, a reviewer with the FDA was so troubled, he conducted his own large study that concluded higher doses of Zorlite significantly increase the risk of heart attack. Green inferred that due to the fairly common occurrence of heart attacks and Zorlite’s broad application, that approval could result in the death or harm of tens of thousands. However, the FDA approved Zorlite over Green’s objections, citing his findings as scientific rumor.
By approving Zorlite, the FDA failed to act morally as defined by deontology. Sometimes describe as “duty” or “rule” based, deontological ethics posits that one’s duty is to do what is morally right and to avoid what is morally wrong, regardless of consequences. Immanuel Kant, who I will describe in more detail later, argued that it is not consequences, but motives that make an act right or wrong. When applying this philosophy to the FDA’s decision to approve Zorlite, it is apparent that the decision was amoral. The FDA failed to meet its obligation to protect the lives and health of individuals above all else by deriving its motivations from the pursuit of budget expansion and expediency. This evaluation is sustained when we learn that the manufacturer, in response to numerous lawsuits, removed Zorlite from the market.
Contemporary deontological ethical theory received its formulation in the writin...
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...ine and are allowing external events to dictate outcomes. Rational being’s free will, and by extension freedom, is subverted in this case.
Deontology dictates that the FDA has a moral obligation to protect the health and well being of individuals above all else. Those individuals are to be seen as ends, not merely means, and that are allowed to be self-determinate in their actions. Regardless of consequences, individuals at the FDA have a duty to do what is morally right. To this end, PADUFA should be repealed; the FDA should revert back to public funding, and a review of the approval process just undertaken. Leaders should incorporate this maxim into the mission of the agency and work to instill a culture of morality. Going forward, a more stringent approval process should be instilled with rigorous testing. Public safety must be the singular goal of the agency.
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.
Today, there are so many legal dilemmas dominating trial for the courts to make a sound legal decision on whose right in a complicated situation. Despite the outcome of the case, the disagreement usually has a profound effect on the healthcare organization, and the industry as a whole. Many cases are arguments centered around if the issue is a legal or moral principle. Regardless what the situation maybe, the final decision is left to the courts to differentiate between the legality issues at hand opposed to justifying a case based on moral rules. According to Pozgar (2012), an ethical dilemma arises in situations where a choice must be made between unpleasant alternative. It can occur whenever a choice involves giving up something good and suffering something bad, no matter what course of action is taken (p. 367). In this paper, I will discuss cases that arose in the healthcare industry that have been tried and brought to justice by the United States court system.
In the Lundbeck’s Pentobarbital case it describes the unattended effects of the drug Nembutal. The attended purpose of the drug is to treat strong seizures in epileptic patients but it was also being used to kill prisoners on death row. This caught Lundbeck off guard and made them act in response to this dilemma. The issue is that this violates some human rights and can ultimately shut down the company.
The Prescription for Disaster is written, directed, produced, and hosted by Gary Null. Gary Null received an associate’s degree in business administration. His alma mater is a Mountain State, a 2-year college. He later goes to Union Institute and University for his Ph.D. in human nutrition , but he still does not have enough education or experience to speak on medical drugs compared to others in this field. He offers valid issues in the pharmaceutical industry, but most of his complaints are exaggerated and generalized to all in the medical field. The extreme bias of the Prescription for Disaster puts the validity of this documentary into
Many people throughout the world visit the United States every year to receive medical treatment. This is due to our excellent pharmaceutical industry as it spends million of dollars and many hours of research to come up with what we can only describe as “miracle” drugs and treatments. Part of the success of many of these medications is because the pharmaceutical industry is highly regulated by policies that protect the public from accessing drugs that have not been fully tested and found to be “safe”. However, this was not the case until the late 1990s and early 2000s. One time in history that highly influenced the strict regulations we currently have was the nationwide contamination of patients through blood transfusion or by consuming medications
"In the past two decades or so, health care has been commercialized as never before, and professionalism in medicine seems to be giving way to entrepreneurialism," commented Arnold S. Relman, professor of medicine and social medicine at Harvard Medical School (Wekesser 66). This statement may have a great deal of bearing on reality. The tangled knot of insurers, physicians, drug companies, and hospitals that we call our health system are not as unselfish and focused on the patients' needs as people would like to think. Pharmaceutical companies are particularly ruthless, many of them spending millions of dollars per year to convince doctors to prescribe their drugs and to convince consumers that their specific brand of drug is needed in order to cure their ailments. For instance, they may present symptoms that are perfectly harmless, and lead potential citizens to believe that, because of these symptoms, they are "sick" and in need of medication. In some instances, the pharmaceutical industry in the United States misleads both the public and medical professionals by participating in acts of both deceptive marketing practices and bribery, and therefore does not act within the best interests of the consumers.
ABSTRACT: In light of interpreting a paradox of irrationality, vaguely expressed by Donald Davidson in the context of explaining weakness of will, I attempt to show that it contains a significant thesis regarding the cognitive as well as motivational basis of our normative practice. First, an irrational act must involve both a rational element and a non-rational element at its core. Second, irrationality entails free and intentional violation of fundamental norms which the agent deems right or necessary. Third, "normative interpretation" is only possible for objects that are both natural events and capable of mental operations which presuppose some freedom of will as well as constructive representation of the surrounding reality. Fourth, there is always a question of whether we strike the best balance between fitting individual mental items consistently with the overall behavior pattern and keeping our critical ability in following certain normative principles which constitute our rational background. Fifth, the paradox of irrationality reflects and polarizes a deep-seated tension in the normative human practice under the ultimate constraints of nature. Finally, the ultimate issue is how we can find the best lines on which our normative rational standards are based-"best" in the sense that they are close enough to limits of human practical potentialities and are not too high as to render our normative standards idle or even disastrous.
The author explains how randomized clinical trials put physicians in ethically intolerable positions of choosing between the good of the patient and that of society. A kantian argument is formed when the author explains how the physician has the duty to tell the truth and not use the patient as a mere means to satisfy the needs of a majority. The well being of the patient is far more important than that of the society when it comes to treatment by personal physician, the Author suggests that there should be alternatives to randomized clinical trials to deal with observer bias and patient selection. The overall message of the article stresses the importance of a patient’s well being over the well being of a society because the physician has the duty to help the patient improve his/her health.
Doctors work under intense pressure, and if a pill could fix a patient’s problems than many saw nothing wrong with that. What exacerbated the problem was that many hospitals also changed their modus operandi with regards to treatment. In some hospitals, “doctors were told they could be sued if they did not treat pain aggressively, which meant with opiates (95). However once the patient became addicted and could no longer get their prescription legally refilled, the drug dealers saw their chance. What is surprising is the fact that pharmaceutical companies acted in the same manner as drug dealers. Both sides did not care about the end user, and the problems they would have to deal with after using what was given to them. Their motive was purely to profit as much as possible, and they did not care about who would get hurt as a result of their
Large pharmaceutical industries are making big profits on medications because they charge high prices for profit. These pharmaceutical companies are overcharging for medications that are essential to maintaining the health of patients. Having such a high cost for medication prevents patients from receiving the care that they need. This may result in patients resorting to desperate measure such as stealing and other illegal acts. The pharmaceutical industry need to reevaluate their ethical standards because the way that these companies are going about pricing their drugs is preventing patients from living a health life. These profits come at an expense of people who depend on those medications to maintain a quality of life. It is not ethical
and ethics. Outside advisors to the FDA have listened to hearings and a committee is to focus
In health care there is a fine line between what is ethical and what is not. As time goes on this line becomes thinner and thinner. In the article The Moral Case For The Clinical Placebo, Azgad Gold and Pesach Lichtenberg are two researchers that argue that there are exceptions to this fine line when talking about placebos. They specifically argue, “The intentional use of the placebo, in certain circumstances and under several conditions, can be justified.”1 The placebo is rapidly becoming a problem because it is now a commonly prescribed drug and many people have different ethical views on the topic.
The FDA is vital to our country, albeit makes mistakes. Sometimes the FDA can be too
The history of medical research in the twentieth century provides abundant evidence which shows how easy it is to exploit individuals, especially the sick, the weak, and the vulnerable, when the only moral guide for science is a naive utilitarian dedication to the greatest good for the greatest number. Locally administered internal review boards were thought to be a solution to the need for ethical safeguards to protect the human guinea pig. However, with problems surrounding informed consent, the differentiation between experimentation and treatment, and the new advances within medicine, internal review boards were found to be inadequate for the job. This led to the establishment of the National Bioethics Advisory Commission by President Bill Clinton in the hopes of setting clear ethical standards for human research.
The article titled “Contemporary Ethical Analyses: A Shortfall in Scientific Knowledge” describes the ethics through the public’s eye. One of the major ethical issues brought up is informed consent.