Practical insights for compliance and ethics professionals and commentary on the intersection of compliance and culture.

Round-up on bioethics in medicine

Bioethics is a field of ethical thought and theory which focuses its debate on the relationship between society and biological sciences. These two sets of interests intersect and collide very frequently in medicine, where the impact of scientific advancement on people can be truly a life or death matter. Researchers, doctors, hospital organizations, medical service and product providers, and patients themselves all contend with bioethical dilemmas. With the ever-evolving advancement of AI and other technologies, medicine, like almost all areas of human life is being transformed and along with it, the ethical choices and challenges present are changing too.

  • As previously discussed in this blog’s coverage of whistleblowers in the pharmaceutical industry, the sales and marketing of prescription drugs is a practice full of risks for fraud and misconduct. Pharmaceutical companies paying or otherwise influencing doctors to recommend and prescribe their products to their patients is ripe for conflicts of interest issues. Doctors who might prescribe medication for any reason other than the most appropriate treatment protocol and wellness outlook for their patients, to whom they owe a high standard of professional care, pose great risk of causing both intentional and negligent harm. The risk of this is exceptionally troublesome when the doctors have histories of fraud or misconduct.  Payments from pharmaceutical companies to doctors are legal and not unusual, but they are also certainly controversial and pose significant bioethical challenges to appropriate patient care. In this case, there is definitely a call for compliance controls and ethical decision-making incentives, in that the conduct not against any law or regulation but may certainly run afoul of society’s expectations or medical institutions’ business values:  Drugmaker paid doctors with problem records to promote its pill
  • Traditional Chinese medicine, which uses herbs, plant, and animal parts to make teas or soups, has been relied upon as a popular remedy for centuries. While the practices of clinics offering these ingredients and instructions for using them as cures have been largely unchanged all this time, in recent years technological innovation has reached even into these farthest corners of medical practice. Some of these old-fashioned recipes have gotten a modern variation, turning them from culinary creations to formulations for injectable drugs. The risk lies in the possibility that the patient taking the drug might have an adverse reaction, as the injectable versions of these drugs contain many different compounds, making diagnosing an allergy or contamination very difficult. As major companies enter this market estimated at $13 billion in sales value, doctors are prescribing drugs that are largely unregulated, untested, and unknown. This presents a huge regulatory challenge to ensure public safety and to set supervisory standards for prescription and administration of the drugs:  Patient Deaths Show Darker Side of Modern Chinese Medicine
  • Recently an elderly, unconscious patient showed up in Miami, Florida hospital with a shocking tattoo that read “DO NOT RESCUSCITATE.” Doctors and nurses found themselves struggling to resolve the ethical dilemma of determining their patient’s true desire for care and to what extent. In the state of Florida, an order to not resuscitate (DNR) is valid only if it is completed on an official form and printed on the designated yellow paper. This patient did end up having such a legal form, so when his condition deteriorated eventually, the valid DNR was honored. However, doctors did debate what reaction, if any, they owed to the tattoo and the patient’s evident choice to make his DNR wishes emphatically clear. The medical team in question here provided basic care, sought ethics advice, and got the support system of social workers involved to make a collaborative, respectful patient care plan. The question of what would motivate a patient to have such a tattoo, however, and the wide variety of medical and legal reactions it can provoke, presents an interesting bioethical dilemma in end-of-life care: What to Do When a Patient Has a ‘Do Not Resuscitate’ Tattoo
  • Continuing on this theme of patient care at the end of life, another compelling bioethical dilemma is in the provision of non-essential treatment in hospice. In this case, a patient wanted eye surgery to restore his vision for the last days of his life. He desired comfort, independence, and reconnection with his family before he died that being able to see again could uniquely give to him. Some care providers, however, would not find it acceptable to perform surgery on someone who would die only a few weeks later, incurring costs and risks to provide ultimately unnecessary treatment. The question of when and why to provide this sort of treatment to hospice patients has arguments for cost and efficiency on one side and dignity and compassion on the other: Should Eye Surgeons Fulfill A Dying Man’s Wish To See His Family?
  • During all surgeries and medical treatments, there is an ever-present risk that something could go wrong and the professionals performing the procedure will need to stray from the expected protocol. While this is done in the best interests of treatment success and preventing harm or even saving lives, these interventions present difficult challenges to consent and control. In the scenario of childbirth, these concerns are especially fraught: Doctors who ignore consent are traumatizing women during childbirth

The moral and ethical questions posed in the evolving practice of medicine are and will continue to be the subject of frequent popular debate. Medical care providers confront these issues in their work and standards for and expectations of patient care are impacted by decision-making on these bioethical dilemmas.

READ MORE

Round-up on compliance of aging and death

Many of the contemporary challenges to the meaning of human life and the responsibility of organizations, individuals, regulators, and even governments to contend with them on a legal or regulatory level come from technology. Indeed, bioethics and design ethics are rich with ethical dilemmas caused by advancements of sophisticated technologies such as artificial intelligence and its many applications. However, there is one philosophical area that is in tension with societal existential constructs and is as old as life itself – aging and death.

The ethical dilemmas stemming from the legal and moral responsibilities humans have to themselves and each other as the end of life approaches are contentious and among the most difficult possible. These dilemmas go to the core of society’s moral ideas about the value of life, the extension of human rights throughout physical or mental incapacity due to age, and the treatment of patients and their bodies through and beyond death.

Legal guardians, funeral homes, hospitals, and other individuals and organizations working in and making profits from business related to aging and dying – encompassing legitimate activities as well as illicit ones – all have various duties to their clients and are subject to societal and legal expectations and norms. However, inspection and enforcement efforts are often uneven and struggle to keep pace with the challenges posed by abusive practices or organizational misconduct. Threats to the rights of individuals and the dignity and proper treatment – or at least clear and honest disclosures – that are expected by patients and their families, must be the focus of future regulatory scrutiny and improvement.

  • Overreaching paternalism in guardianship of senior citizens is a highly disturbing trend which has been enforced by the courts in some jurisdictions. Legal guardians pay themselves from their wards’ estates; in some cases they have hundreds or even thousands of clients and force out family members or friends so that they can exert their control and get paid for it. Of course, this is a necessary system for the care of vulnerable senior citizens who need help administering their affairs. However, it is also ripe for misuse by opportunistic individuals, to the great detriment of the seniors they take on as wards and their loved ones. The financial and social abuses that can occur in these cases are frightening and appalling. Legal guidelines and supervisory scrutiny of these guardians should be standardized across jurisdictions to avoid undue harm to any population and to balance the commercial caretaking aspects of the activity with the rights and dignity of the individuals concerned:  How the elderly lose their rights 
  • Funeral home regulation and inspection is currently a patchwork system at best. Gross abuses and lack of internal controls have been the subject of a number of recent investigatory reports. Employee misconduct or insufficient internal policies and procedures at an operation like a funeral home has obviously devastating potential to cause harm to families of departed individuals at a vulnerable and painful time in their lives. Following the loss of a loved one the thought that the personnel of the funeral home trusted with their body might store the remains improperly or misuse their organs and parts is a concept that is hard to even conceive. However, due to insufficient supervision and inconsistent regulatory and investigative practices, these terrible scenarios play out all too often. A coherent and cohesive regulatory framework with the strength to punish misconduct and enforce expectations of operating standards must be implemented:  Gruesome Discoveries at Funeral Homes Put Spotlight on Spotty Regulations
  • On a related note, the dark reality of the organ trade has been the subject of a number of recent investigatory reports as well. Far from just urban legends about crimes that can take place in far-off lands, body brokers are very real and operating in the United States. While many of them do conduct legitimate business for scientific or medical purposes, others trade illicitly or take advantage of individuals who unknowingly give their body parts upon death or those of their loved ones to be later sold for profit by brokers. Fraud and misrepresentation in this industry violates the dying wishes of individuals or the difficult decisions made by families. The ease with which these illicit transactions are conducted is shocking, with human limbs or organs being bought and sold like spare car parts by some individuals. Like funeral homes, an overarching regulatory system needs to be put in place to monitor and inspect these businesses and implement enforcement actions when necessary:  The Body Trade
  • Turning away from illicit or abusive activities to technological advancements that touch upon aging and death, the reach of artificial intelligence has begun to stretch into this area as well. Robots and robotic devices are no longer the figment of the imagination of a distant future. Many organizations are beginning to utilize them in rudimentary form for a variety of assistant-level activities and are trying to develop the AI technology to use it even more in the future. This extends to patient care as well; hospitals and nursing homes are now exploring using robots to assist nurses in treating patients. Machine learning may eventually be able to automate many aspects of basic care, removing human error and relieving non-robotic nurses to focus on more complex or individually-tailored care. This could be a great efficiency for hospital staffing in the future, but it remains to be seen how non-human interaction in the patient care arena will impact the aging experience. Compassion and humility are often of great mental importance when contending with the forces of aging and illness. A mix of human and robotic care of patients will need to be carefully devised to ensure that these needs are met: Hospitals Utilize Artificial Intelligence to Treat Patients
  • Life extension has been a romantic subject of philosophical and scientific desire for millennia. For as long as people have been alive, they have tried to figure out ways to prolong or prevent dying, sometimes delving deeply into the mysterious and esoteric. Current quests in this area are focused on high-tech solutions. Silicon Valley has turned its most sophisticated efforts toward life extension in seeking to “solve for death.” At the very least, these attempts may derive a technology that greatly impacts aging or pushes human life expectancies far beyond the current normal range. Within a generation this may the force of great societal change that will redefine the needs of aging populations that live for longer and continue the quest to avoid death completely: Seeking eternal life, Silicon Valley is solving for death

As demonstrated by the foregoing stories, improper practices and abuses of power, as well as technological advancements, pose risks to the nature of aging and death as it is currently defined within society. Supervisory frameworks must be developed and strengthened to protect the most vulnerable of individuals and ensure that they and their families are not treated unjustly. Risk assessments and coherent, holistic regulatory guidance should be in place to ensure that these protections are upheld.

READ MORE