November 20, 2015 | Posted By Benita Zahn, DPS

I like watching a doctor drama as much as the next person. But I don’t watch it like my friends. That’s because I’m always on alert to the bioethical issues playing out on the small screen. Often the show writers get the issues right and the program, along with its entertainment value, serves as an educational tool for the community. But when they get it wrong my forehead wrinkles and I grit my teeth. And that’s just what happened while watching a recent episode of the long running ‘Grey’s Anatomy’.

The show centered around a female patient who was diagnosed with a pituitary tumor that was causing her to add inches to her height but more importantly, threaten her life. She was given two options: surgery or probable death. The chief of surgery, the persuasive and powerful Dr. Miranda Bailey ( played by Chandra Wilson) made a clear case for surgery. But the patient wasn’t buying it and wanted to be released from the hospital. Here’s where my brow began knitting. The good Dr. Bailey wouldn’t let her go.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

November 16, 2015 | Posted By Lisa Campo-Engelstein, PhD

As I have discussed in previous blogs, fertility preservation for cancer patients can be quite expensive and insurance companies do not cover it. Fertility preservation for cancer patients is excluded because cancer patients are generally not currently infertile, but instead they have anticipated infertility due to their cancer treatment. I have argued that insurance companies should cover fertility preservation because it is not ethically different from other treatments for iatrogenic conditions currently covered for cancer patients. For example, insurance covers other quality of life treatments such as wigs for alopecia and breast reconstructive surgery following mastectomy. Like these treatments, fertility preservation is not lifesaving, but can significantly improve quality of life, as infertility can lead to depression, anxiety, and distress. Since much of medicine today focuses on improving quality of life for people with non-life threatening conditions (e.g. poor vision, back pain, seasonal allergies, sexual dysfunction, etc.), it does not make sense to exclude fertility preservation on the basis that it is not life saving.  

However, some question whether fertility preservation for cancer patients is a just use of finite health care resources based on economic reasons. One cycle of IVF is on average $12,400 and estimates for ovarian tissue cryopreservation range from $5,000-$30,000. Furthermore, annual storage fees for frozen gametes and embryos can run up to hundreds of dollars a year While ART are very expensive on the individual level, they are not on the broader social level: in fact, they account for only 0.06% of the total health care expenditure in the United States. The lack of insurance coverage for fertility preservation raises the justice concern that only certain individuals will be able to utilize it, namely those who can pay out-of-pocket for it. These individuals are most likely from the same demographic as the primary users of ART: white, educated, and middle- and upper-class. While 14 states currently have mandates requiring insurance companies to cover some types infertility treatments, there are no similar laws for fertility preservation. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

November 11, 2015 | Posted By Paul Burcher, MD, PhD

A couple of weeks ago I was I was the faculty attending on Labor and Delivery. We were inducing a woman with severe pre-eclampsia and an IUGR fetus. Things went well until she was five centimeters dilated, at which point the fetal tracing went rapidly from category one to category three (reassuring to really bad). I quickly explained the situation to the patient with a resident and a nurse in the room. She heard the reasons I was recommending a cesarean section, a brief discussion of its risks, and an even briefer discussion of the alternatives (continue labor placing the fetus at risk of permanent injury or death). She had no questions, and since she had already signed a cesarean consent at the beginning of the induction, we proceeded to the operating room to perform a cesarean.  She needed general anesthesia because her platelets were low, so it was too risky to give her a spinal anesthetic. During the induction but before intubation, the circulating nurse announced that she couldn’t find the “informed consent” and that we could not proceed. My response involved a reference to male cattle manure, and the comment that informed consent had just happened and that she had witnessed it herself. The anesthesiologist agreed, and the cesarean section occurred without delay.

This case exemplifies the ambiguity around “informed consent.”  The nurse was referring to a document, a signed piece of paper; I was referencing a conversation, a process involving sharing information and answering questions. From a legal perspective, informed consent would seem to represent the document, whereas from an ethical perspective it is the process, not the paper that embodies informed consent.  Of course, ultimately, both have a role to play, and in the case of a significant procedure it is best to have both sides of this informed consent coin documented.  But what I would like to suggest is that the signed document represents an artifact—a physical symbol that two parties agree that the real nature of informed consent has been fulfilled.  The piece of paper is derivative, and a signed document that lacks the ethical underpinning of a complete and valid consent discussion is meaningless. A lawyer would probably give a slightly different answer, but this is an ethics blog, not a discussion of medical malpractice.  

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

November 5, 2015 | Posted By Zubin Master, PhD

Several months ago, I read an interesting article written by Sara Reardon and published in Nature titled “Uneven response to scientific fraud”. The Science and Nature journals are great at providing news surrounding scientific topics, including discussions on scientific fraud. In this article, the author discusses a case of misconduct, which is typical to other cases and certainly not the most egregious in terms of harming patients in a trial or a danger to public health. Yet despite this, the penalties this researcher received were quite harsh. And as I have written in previous blogs, it seemed no one else is to blame including research institutions.

On July 1, 2015, Dr. Dong-Pyou Han was sentenced to 57 months in prison for research misconduct. Dr. Han is a biomedical scientist who was let-go from Iowa State University for fabricating and falsifying data of a HIV vaccine research study where he spiked rabbit blood samples with human HIV antibodies which made it appear that the rabbits were developing immunity. In addition, he has also been fined 7.2 million dollars. Because Han’s research was supported by the U.S. National Institutes of Health (NIH), the investigation was performed at his home university with reports sent to the U.S. Office of Research Integrity (ORI). He admitted to misconduct and explained his actions by saying he tried to cover up a mix-up in samples he had made years ago. As such, ORI debarred him from funding for up to 3 years. In the article by Reardon, several experts of misconduct explained that receiving a 57 month prison sentence is quite rare. These experts also explained that ORI’s maximum debarment of 3 years is typical for such cases and stiffer penalties are used for those who have greatly impacted public health or harmed human participants in a clinical study. But Dr. Han’s case received higher profile than most because Iowa senator Mr. Charles Grassley wanted to make an example of him. Grassley felt that the penalty of losing a job and 3 years debarment for such a case was light compared to the public deception and the waste of millions of taxpayer dollars. While I would agree with the Senator, I am think that 57 months in prison is a bit over the top given the type of harm. But my contention is not really to talk about the penalty given to Dr. Han. Rather, I am interested in knowing why again, as is the case with almost all cases of research misconduct, a focus has been placed solely on the culprit and there is no blame or responsibility shifted to institutions.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

October 23, 2015 | Posted By Wayne Shelton, PhD

The issue of truth telling in medicine was a lively concern in the early days of modern medical ethics during the 1970’s. A new moral awareness had emerge that provided a clear moral rejection of the paternalistic approach taken in the physician-patient relationship that prioritized the traditional values of beneficence and non-maleficence over truth telling. Of course the key development that fueled this new moral perspective as well as the growing passion for medical ethics was the newfound sense that arose beginning in the 1960’s that patients with capacity have a fundamental right both to refuse unwanted treatment and give voluntary informed consent to treatments they were considering. It became obvious to students of medical ethics that if patients are to be able to exercise their right to give voluntary informed consent they must receive a full and accurate disclosure of the relevant information necessary for them to make a decision.

Up to the early 1960’s, patients coming into the health care system very well may not have had an opportunity to give voluntary informed consent. Giving patients this opportunity just wasn’t part of the medical culture. In the early 1960’s it was common for oncologists to not disclose a diagnosis of cancer; by the late 1970’s there was almost universal agreement that full disclosure was the expectation. The full moral force of the principle of respect for patient autonomy happened relatively quickly, especially after the Belmont Report of 1978, which articulated the basic principles of medical ethics (though non-maleficence was subsumed under beneficence). There is no question that the physician-patient relationship has been evolving ever since with new levels of expectations and involvement of patients and their surrogates. There is now universal agreement that physicians are expected to be truthful to patients and accurately disclose their medical condition, including diagnosis and prognosis. Without this first basic step of truth telling in disclosing the medical facts to the patient about their condition, patients cannot exercise their right to express their preferences and wishes about medical treatment and care goals, and specially give voluntary informed consent to medical interventions to treat their condition.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

October 21, 2015 | Posted By Jane Jankowski, DPS, LMSW

My original plan for this blog was to consider whether or not there remained a need for the old “Drunk Tank” way of managing persons who are acutely intoxicated by allowing them to sleep off or wait out their inebriation at the police station before determining whether or not further mental health care was needed, rather than bringing individuals to hospital emergency rooms for supervised sleep and conversation about detox services or psychiatric evaluation. Though the task of caring for acutely intoxicated persons, sometimes folks who are frequently seen in ERs repeatedly, can seem to be an inappropriate use of resources by clinicians we must appreciate that the motivation is often about safety, protection, and the welfare of the patient as well as the public. In the social context of fear and mistrust toward law enforcement following the many egregious cases of police brutality, my focus is a reminder of the ways in which police can, and often do, intervene with persons who have mental illness and addiction in order to protect these vulnerable mentally ill individuals. In no way do I condone the misconduct and violence we have come to hear about too often, but rather will focus on the important ways police can and very often do work with mental health professionals to assist persons in acute crises.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

October 16, 2015 | Posted By John Kaplan, PhD

I have a riddle for you.  Start with six attorneys; add three management consultants, three financial executives/advisors and a couple of bankers. Sprinkle in, one each, clothing store chain CEO and entertainment retail chain CEO. Add executives from a supermarket chain, a construction company, and a paper products company. Fold in a hedge fund manager, real estate executive, and an accountant. Finish with a reputation management expert and exactly one educator and one physician. What have you got? Perhaps you have the membership of an exclusive club, perhaps a class reunion of an exclusive prep school. No not these.  I will not make you guess any more. What you have is the Board of Directors of a large academic medical center which includes a major teaching hospital and a medical school. This academic medical center educates medical students and physicians, graduate students in science and other health professions. This teaching hospital is a major health care provider in the state capital of a large northeastern state. The academic medical center is the leading biomedical research organization in the region.

The Board of Directors is fully responsible for the governance of this large and complex organization. This organization has a mission to educate, to conduct biomedical research, and to provide patient care services. I was expecting to see that this list of directors would include expertise from renowned educators with national reputations. I was expecting to see a list containing outstanding biomedical researchers who discovered knowledge which made the world a better place. I was expecting leaders from the field of healthcare and medicine. But that is not what I found. I was surprised.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

October 12, 2015 | Posted By Bruce White, DO, JD

On September 16, 2015, President Obama nominated the internationally known Duke University cardiologist-researcher Robert M. Califf, MD, to be Commissioner of Food and Drugs. He will replaceMargaret Hamburg, MD, who left the agency last March. Dr. Califf – a registered Democrat but well regarded by Senate Republicans – has served as Deputy Commissioner at the F.D.A. since February. The Senate must confirm the commissioner.

Immediately prior to joining the F.D.A., Dr. Califf was professor of medicine and vice chancellor for clinical and translational research at Duke. While at Duke, he founded the Duke Clinical Research Institute and served as director of the Duke Translational Medicine Institute. A highly esteemed expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and authored or co-authored over 1,200 publications in the peer-reviewed literature. He is one of the American Medicine’s most frequently cited authors in the biomedical sciences. His credentials are unimpeachable. Two of Dr. Califf’s area of interests are improving the design of drug research projects and streamlining the regulatory process to bring innovative drugs to market more quickly.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

October 9, 2015 | Posted By Valerye Milleson, PhD

“People need to be made more aware of the need to work at learning how to live because life is so quick and sometimes it goes away too quickly.” – Andy Warhol

This past weekend was the last one for The Late Drawings of Andy Warhol: 1973-1987 exhibit at The Hyde Collection Museum in Glen Falls, and I almost didn’t go to it. I told myself there were far too many other things to do: the stack of recent journal articles I’ve been meaning to get to; student assignments that are in need of grading; the upcoming presentations for which I haven’t even begun putting together powerpoints; the apartment that, despite ongoing efforts, never seems to be completely clean; the piles of unwashed or unfolded laundry; and so on. In terms of triaging my limited time, a two-hour round trip trek to see a handful of sketches hardly seemed sufficiently important.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

October 6, 2015 | Posted By Claire Horner, JD, MA

A Catholic hospital came under fire recently for stating that it would not permit doctors to perform a tubal ligation during a c-section scheduled for October.  According to news reports (including anarticle written by the patient herself), the pregnant patient has a brain tumor, and her doctor have advised her that another pregnancy could be life-threatening.  Her doctor has recommended that she have a tubal ligation at the time of her c-section.  While my knowledge about this hospital, this case, and the participants is limited to what has been reported in the media, it raises an interesting question: in our pluralistic society, where conscientious objection is respected while maintaining a patient’s right to a certain standard of care, is it ethical to allow a religiously-affiliated health care institution to refuse to provide certain treatments it finds morally objectionable?

As background, the Catholic Church has historically been outspoken on bioethical issues and has a strong and robust bioethical teaching.  Catholic hospitals are governed by the Ethical and Religious Directives for Catholic Health Care Services (ERDs), a document promulgated by the United States Conference of Catholic Bishops (USCCB) that clearly articulates the bioethical policies that must be followed in a health care institution based on the Church’s moral teachings.  It explains the Church’s teaching against direct sterilization as a method of birth control based on the principle of double effect.  “Direct sterilization of either men or women, whether permanent or temporary, is not permitted in a Catholic health care institution.  Procedures that induce sterility are permitted when their direct effect is the cure or alleviation of a present and serious pathology and a simpler treatment is not available.” (Directive 53).  In other words, if the sterilization procedure directly treats a pathology, it is licit; if it is used as a form of birth control to prevent a pregnancy, even if that pregnancy would be life-threatening, it is not licit.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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