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 To this end, PADUFA should be repealed; the FDA should revert back to public funding, and a review of the approval process just undertaken.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.
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 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
An ethical dilemma that is currently happening in the medical field regards pain management. Doctors and other medical professionals are faced with this ethical decision on whether to prescribe strong pain medication to patients who claim to be experiencing pain, or to not in skepticism that the patient is lying to get opioids and other strong medications. “Opioids are drugs that act on the nervous system to relieve pain. Continued use and abuse can lead to physical dependence and withdrawal symptoms,” (Drug Free World Online). Opioids are often prescribed to patients experiencing excruciating pain, but doctors are faced with prescribing these drugs as an ethical issue because only a patient can measure the pain they are in, it is simply impossible
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
Slosar, J. P. (2004). Ethical decisions in health care. Health Progress. pp. 38-43. Retrieved from http://www.chausa.org/publications/health-progress/article/january-february-2004/ethical-decisions-in-health-care
FDA, so many people were harmed. Even other countries versions of the FDA approved it which
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.
Phatak, A. (1998 йил 01-01). The pharmaceutical industry and the medical profession. Retrieved 2012 йил 19-01 from Indian Journal of Medical Ethics: http://www.ijme.in/064cr131.html
In Lee Ann Fisher Baron’s “Junk Science,” she claims that the “food industry with the help of federal regulators” sometimes use “[a science that] bypasses [the] system of peer review. Presented directly to the public by…‘experts’ or ‘activists,’ often with little or no supporting evidence, this ‘junk science’ undermines the ability…[for] everyday consumers to make rational decisions” (921). Yet Americans still have a lot of faith in the U.S. Food and Drug Administration (FDA). According to a 2013 Pew Research study, 65% of Americans are “very favorable” or “mostly favorable” of the FDA. When it comes to what people put in their bodies, the FDA has a moral obligation to be truthful and transparent. The bottom line of the FDA’s myriad of responsibilities is to help protect the health of Americans. Deciding what to eat is a critical part of living healthily, and consumers must be able to trust that this massive government agency is informing them properly of the contents of food. While the FDA does an excellent job in many areas, it has flaws in other areas. One of its flaws is allowing the food industry to print food labels that are deceptive, unclear, or simply not true (known as misbranding). This is quite the hot topic because a Google search for “Should I trust food labels” returns well over 20 million results, many of which are blog posts from online writers begging their readers not to trust food labels. HowStuffWorks, a division of Discovery Communications, published an online article whose author claims that “[the food industry] will put what they want on labels. They know the game….” While the food industry is partially at blame for misbranding, the FDA is allowing it to happen. If a mother tells her children that it is oka...
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.
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.
Miller, F. (2003). Therapeutic Misconception in the Ethics of Clinical Trials,. The Hastings Center Report.
Human error should not be punished by blame or shame. It should focus on process changes, procedure changes, effective education, change in design, and consideration of environmental factors Lecture notes, 2018). Just culture attempts to differentiate between human error, at-risk behavior, and reckless behavior to accomplish the best way to handle situations that have harmed the patient. The treatment of pharmacists whose actions have harmed a patient is demonstrated in the Eric Cropp case. He was accused of involuntary manslaughter for the death of a 2 year old girl by not checking a lethal dose of a cancer compounded salt solution (Cleveland, 2009). Prosecutors wanted charge Eric with reckless homicide even though this was a human error. According to Just Culture Eric should have been supported due to the failure of the system but instead he was treated harshly like a cold killer. Eric was sentenced to five years in prison with a 10,000 fine (Cleveland, 2009). This may have been evaluated differently with the concept of Just Culture because Eric would have received fair
There were many ethical issues within this case; the first indication of an ethical problem was the administration of an incorrect medication to the patient. The doctor, administration, and providers involved in the care of the patient must decide what is ethically moral when informing the patient. I believe that it is the patient’s right to know that she received the wrong medication for a number of days. Although no major medical consequences occurred, I believe this
The belief that our realities are a result of various determined factors, such as the environment around us, is especially rational. Even though determinism exists, it does not rule out responsibility and freedom. The view that people choose to act independently out of free will only goes so far. Often, violence or other external factors are the root of various human behavior. When this happens, the event is not caused by something in the person, but rather a predetermined factor. Ultimately, individuals do have a choice, but the behavior they exhibit is always subject to some type of environmental or biological determinism.