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When the rapper T. I. disclosed on a podcast that he takes his 18-year-old daughter to a yearly gynecological examination to ensure that her hymen is still intact, the reaction of most people was condemnation. His obsession with her virginity is creepy, his subjecting her to an invasive procedure that has no medical value is controlling, and his willingness to talk about it publicly displays contempt for her rights to privacy and dignity. Some think that the law should prohibit physicians from performing or supervising virginity examinations. But the law is not the best means for dealing with the problem, and the problem is not simply virginity testing.

The post What’s Wrong with Virginity Testing? appeared first on The Hastings Center.

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Children are not small adults. This is a phrase we say in pediatrics on a regular basis. The reason for such an absurd comment is that we are constantly faced with medical decisions that force us to rely on adult data to inform our practice. Pediatric patients face unique diseases and metabolize medications differently from adults. Their ability to recover from injury is often superior to their adult counterparts and thus the Quality Adjusted Life Years can be substantially different.  I argue that we have an ethical imperative to conduct pediatric research because 1. research brings forth generalizable knowledge for the good of the pediatric population and 2. because research guides clinical practice and the physician has a duty to provide the best possible care to the patient.

Research in human subjects is justifiable if it satisfies the following conditions: 1. A goal of valuable knowledge, 2. A reasonable prospect that the research will generate the knowledge that is sought, 3. The necessity of using human subjects, 4. Favorable balance of potential benefits over risk of the subjects, 5. Fair selection of subjects and 6. Measures to protect privacy and confidentiality. This list does not suggest any condition that could not be applied to pediatric research subjects as they all promote fairness, beneficence and non-maleficence. Typically, we do not consider clinical research as something that provides significant benefit to the individual subject. Generally, a clinical trial is initiated with equipoise on the efficacy for if not met with equipoise, there would be no need for the study as the outcome would already be known. Thus, if a clinical trial were to test the efficacy of a given medication, the human subject could benefit from being in the trial if the medication works OR could suffer from side effects and receive no benefit from participation. So, although there is potential for individual benefit after participating in the study, the main purpose is to benefit future patients and add to the general knowledge of the topic. A utilitarian approach would look at the potential consequences of pediatric research and determine it to be right or wrong based upon the balance of good or bad. Pediatric research must go through the same pathways as adult research with all human subjects’ trials needing to have a careful justification that the benefits outweigh the risks. Utilitarian theory is focused on value and thus the best action is the one who promotes the most good for all involved. This is precisely the goal of research. Research is conducted to affect change and improve care across a larger population. Through clinical practice, a physician may help hundreds to thousands of patients over the course of a career. However, through research, that same physician could affect the lives of thousands to millions of patients over the course of her life and far beyond. Therefore, in a carefully planned and executed pediatric clinical trial where the potential benefits outweigh the risks, the outcomes could be exponentially beneficial to the pediatric population, thus supported by a Utilitarian approach.

The physician takes an oath to promote the patient’s best interest and to avoid harm. Currently, the majority of treatments we provide to pediatric patients are not evidenced based because no clinical trials have been conducted to test that hypothesis. Therefore, each day we care for pediatric patients without evidence of treatment safety nor effectiveness, we are potentially causing harm. Pediatric researchers support a Kantian theory where morality is judged by their motives. Thus, if a researcher wants to conduct a clinical trial only for the fame from discovering the essential element and not because of a desire to promote good, this would not be a moral-worthy endeavor. Therefore, if we examine the physician’s obligation to her pediatric patient, a duty-based ethical theory would tell us to treat each of them with the best possible practice available. Research guides our clinical practice and help to ensure that we are minimizing harms and maximizing benefits. If we support a Kantian approach, in order to satisfy our obligations, we must utilize the available data to make the best possible decisions, and thus, the available data must come from clinical trials on pediatric patients to ensure scientific rigor.

One objection to pediatric research is that these patients are considered a vulnerable population, incapable of independent informed consent and at risk of exploitation. Due to this fear, special protections have been placed on pediatric research leaving an even more limited pool of subjects in which to study. This is justified by some stating that we should proceed with caution and only permit research when the potential for benefit is extremely likely. However, if the criteria are too narrowed, we risk excluding potential participants from research and unjustly diffusing the risks to a non-uniform population. Rights Theorists would protect the pediatric patient against oppression, unequal treatment, etc. Therefore, upholding the decision to conduct pediatric research allows for the rights of all patients to be upheld and for providers to contribute to the overall body of science, thus practice safer and more effective medicine to the benefit of all patients. When we practice medicine on children without data, we are unnecessarily exposing them to the same risks we fear and are doing so without the oversight and protection imbedded in clinical trials.

In conclusion, I support that pediatric research is both essential and ethical as it 1. generates a generalizable body of knowledge to the benefit of the pediatric patient of the future and 2. clinical practice is best guided by empirical data conducted through research. Clinical ethics outlines our responsibilities as physicians to our patients including veracity, privacy, confidentiality, and fidelity while upholding our role as a clinician. In contrast, research ethics contributes to the greater good by promoting generalizable knowledge for all future patients.

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More than three years ago, Roger Kligler filed a lawsuit in Suffolk County Superior Court, Massachusetts, seeking declaratory and injunctive relief that MAID was a legal option.  On December 31, 2019, the court acknowledged that Kliger "presente...

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I am looking forward to presenting "Medical Aid in Dying: Key Variations among U.S. State Laws" at the National Clinicians Conference on Medical Aid in Dying, next month, at U.C. Berkeley.

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“Exploring ethical issues in TV medical dramas”

The Resident (Season 3; Episode 11): Keeping information from patients; Capitalism and medicine do not mix; Chicago Med (Seasons 5, Episode 10): Doctors and the opioid epidemic; different approaches to treating patients

by Craig Klugman, Ph.D.

The Resident (Season 3; Episode 11): Keeping information from patients; Capitalism and medicine do not mix

Austin’s patient has an infection of the chest that can be cleaned out with surgery and then scar tissue removed in the hope that she can breathe again. She has, apparently, beaten her cancer. The surgery, however, is risky. Austin and Nevins take a good cop/bad cop approach in giving the patient the risks and benefits.…

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On February 5, 2020, Holly Fernandez Lynch will deliver the first Baruch A. Brody Lecture in Bioethics - "Conflicts of Conscience an Implications for Physicians' Gatekeeping Authority." Happily, you can log-on and watch for free.

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Join me at the next Congress of the Word Federation of Right to Die Societies, in Mexico City, from October 27-31, 2020. 

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by Craig Klugman, Ph.D.

This week Las Vegas hosted the 2020 Consumer Electronics Show (CES) where tech companies can show off the devices they hope we will all be buying soon. With an expected market share of $504 million in the next five years, over 200 Digital Health related companies were showing their wares at CES.

The FDA defines digital health as “The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine”. These devices, apps, and programs are supposed to help us learn more about our health and take steps to improve it.…

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In 2012, Compassion & Choices (the nation's oldest, largest and most active nonprofit working to improve care and expand end-of-life options) produced a tremendous conference in Chicago. In the participant program book was a crossword puz...

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A writer in Nature says that China sent a “strong signal” by punishing He Jiankui and two colleagues with fines, jail times, and bans against working again in human reproductive technology or applying for research funding.  (They lost their jobs as well and may not be able to do research work, presumably in any field, …

Continue reading "Chastening and enthusiasm about genome editing"

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