Global Ethics – Medical Ethics – Hospital Ethics Committees – Research Ethics – Public Health

A recently published article in the Journal of Medical Ethics entitled “Through students’ eyes: ethical and professional issues identified by third-year medical students during clerkships”,  reported on the predominant ethical and professional issues cited by medical students.   Kaldjian and colleagues performed a content analysis of 272 Case Observation and Assessments written by  141 third-year medical students at the University of Iowa Carver College of Medicine.  Their analysis identified 35 subcategories of ethical and professional issues within the following 7 major domains: decisions regarding treatment (31.4%), communication (21.4%), professional duties (18.4%), justice (9.8%), student-specific issues (5.4%), quality of care (3.8%), and miscellaneous (9.8%).  Among the “decisions regarding treatment”, issues included “morality of providing treatment given poor quality of life”, “doctor wants intervention/test but patient or family does not”, and “problems surrounding surrogate decision making”.  Regarding Student Specific Issues, issues included “Learning on patients over their objections or without consent”, “asked to compromise my own ethical standards”, and “not being allowed to see a patient (because I am a student”.   Major Communication Issues included:  “breaking patient confidentiality”, “delivering bad news”, “deliberate lies and deception in context of medical care”.

This article contrasts with a previously article listing the ethical issues reported by medical students from the State University of New York Upstate Medical University:  Caldicott CV, Faber-Langendoen K.  Academic Medicine. 2005;80:866.  In this article, the most common issues were “deliberate lies or deceptions”, “patients’ right to refuse recommended treatment”, and “insistence on futile treatment”.

Several recent news items worth mentioning:
Eletronic Physicians Orders for End-of-Life Treatment
States are creating electronic databases that will store physicians’ orders regarding the type of care patients want at the end of their lives. The goal is to make such orders more readily available to emergency workers, as paper based orders (including advance directives) are frequently misplaced. Such orders are called POLST, or physician orders for life-sustaining treatment. Also, such orders will be honored by other physicians in other health care institutions and therefore, no need to interpret wishes in an advance directives, which can differ between different physicians. Read this article here>

Alzheimer’s Tests: Who Controls the Information?  Doctors or Patients? Recent tests (such as MRI and spinal taps and APOE tests) that can predict with some accuracy the likelihood of developing Alzheimer’s are becoming more widespread and raises the question of whether doctors should order such tests and tell patients the results, the concern being that there is no treatment yet for Alzheimer’s. But many patients are saying they want to know. Are physicians being too paternalistic?
Read the article here

Proper Rationing of Transplants??  Recently Arizona decided not to cover the costs of transplants under its Medicaid program, the reason being that the data shows that most people die even with the transplants. But are the data accurate? Read the article here.

Spinal Fusin Surgery and Medicaid Fraud?   Recent data from the Medicaid database show that several medical centers have performed an extraordinary amount of spinal fusion surgeries and the concern is that their surgeons are receiving large payments from the device companies that manufacture the hardware used in such surgeries. Do such surgeons have a conflict of interest? Read the article here.

Enjoy the readings and enjoy the holidays!!

Henry Silverman

Researchers at the Group Health Research Institute and the University of Washington (UW) has published their study in which they discovered that peopled want to be informed and asked for their consent to share their coded, de-identified genetic information in a federal database.  This study, published in the September 2010 Journal of Empirical Research on Human Research Ethics (JERHRE), involved research participants who were enrolled in the longitudinal “Adult Changes in Thought” (ACT) study. When asked as to whether their genetic and medical record information could be shared in the database, 86 percent said “yes.”  Also, of the 365 ACT study participants who had agreed to let their genetic information be shared, 90 percent of participants said they thought it was important to have been asked for this consent – what researchers call “re-consent.”

Since 2008, the National Institutes of Health (NIH) has encouraged many studies to submit genetic information to the federal database of Genotypes and Phenotypes (dbGaP). The reason for this request is that genomic research on large numbers of people can yield insights that aren’t possible with smaller numbers.  For new studies that will enroll participants, informed consent for such data sharing in a national registry can be asked prospectively.  However,  for ongoing studies or completed studies in which biological samples or medical data had been collected previously for other purposes, the issue is whether retrospective or re-consent from the research participants is ethically necessary if the original informed consent did not address the issue of data sharing in a federal registry.

According to the federal regulations governing human research,  key issues for Institutional Review Boards (IRBs) that review such research to consider regarding a requirement for re-consent  is the risk level associating with such data sharing (i.e., risks due to a breach in the confidentiality of the data) and the practicableness of approaching research participants for their re-consent, which often be time consuming and expensive.   If the risks are minimal and re-consent is impracticable, then one can argue that the public good of data sharing in a federal repository outweighs the rights of individual participants to choose whether to participate.  IRBs will differ in their determinations based on their assessment of whether the data sharing represents minimal risk and the impracticableness of obtaining re-consent.  It is interesting to note that in the study published in the JERHRE journal, the participants in the  ACT study were receiving biennial examinations and hence, one could argue that it was not impracticable for the investigators to seek their re-consent.  However, for studies that had previously collected tissue samples and have been closed for years, one could argue that re-contact of the research participants would not be practicable.  Despite such uncertainty in the determining levels of risk and practicableness, one thing is certain, IRBs and investigators need to be mindful of recent high-profile legal cases that have highlighted the issue of consent and trust in research.  These include the Havasupai tribe vs. Arizona State University in which there were group harms; the Parents vs. the Texas health department, in which newborn blood samples were collected and stored without parental consent; and the the story of Henrietta Lacks (The Immortal Life of Henrietta Lacks), in which the highly profitable HeLa cell line was established without the consent of Ms. Lacks.

A recent study mapping the outsourcing of pharmaceutical pediatric research in developing countries has raised the concern of exploitation. The study performed by Duke investigators (Globalization of Pediatric Research: Analysis of Clinical Trials Completed for Pediatric Exclusivity) raises the concern that many of these trials are testing drugs that are unlikely to be reasonably available to the countries from where the research subjects are recruited. The study documented that more than one-third of the trials enrolled patients from a developing country and of these trials, more than one-third enrolled patients investigating cardiovascular and allergy/immunology diseases (e.g., atopic dermatitis and juvenile rheumatoid arthritis). To be sure, more than one-half of the trials involved studies of antiretroviral and antimalarial drugs, which address important health care needs of the developing countries. But a basic safeguard for the protection of potentially vulnerable populations is to test drugs first in populations that are less vulnerable, which would apply to the aforementioned cardiovascular and allergy/immunology diseases. Even if one wants to assume that parents gave volunatary informed consent for the enrollment of their children in research (a questionable reality), one needs to question the conclusions of institutional review boards (IRBs) that gave approval to the performance of these studies. Similar concerns have been raised in Chris MacDonald’s post on the Research Ethics Blog.

Investigators have found that patients with terminal lung cancer began receiving palliative care immediately at the time of diagnosis  were happier, more mobile,  in less pain as the end-of-life and ALSO:  lived nearly three months longer than those who did not receive palliative care.

The study was published in The New England Journal of Medicine and contrasts with the rhetoric about ‘death panels’ that surfaced during the debate on the Obama  Administration’s health care bill, thus casting doubt on the decision to strike end-of-life provisions from the health care overhaul passed last year.

In the three-year study performed at the Massachusetts General Hospital, 151 patients with advanced lung cancer were randomly assigned to get either oncology treatment alone or oncology treatment with palliative care — pain relief and other measures intended to improve a patient’s quality of life. They were followed until the end of 2009, by which time about 70 percent were dead.  Those getting palliative care from the start reported less depression and happier lives as measured on scales for pain, nausea, mobility, worry and other problems. Moreover, even though substantially fewer of them opted for aggressive chemotherapy as their illnesses worsened and many more chose to forgo cardiopulmonary resuscitation,  they  lived almost three months longer than the group getting standard care, who lived a median of nine months.

Palliative care is traditionally seen as an intervention only for those in their last weeks of life.  But, contrary to this opinion, the institution of palliative care makes sense from the beginning of an illness.

At the urging of consumer groups and key members of Congress, the Obama administration is rewriting new rules on medical privacy. The expressed concern is that the current rules do not adequately protect the rights of patients. The rules specify when doctors, hospitals and insurers must tell patients about the improper use or disclosure of information in their medical records. The concern, however, is under the current rules, health care providers and health insurance plans would have to notify patients of a privacy breach only if they found that the violation posed “a significant risk of financial, reputational or other harm to the individual.” But, how does a hospital or an insurance company know whether an improper disclosure will harm a person’s chances for promotion or endanger a victim of domestic abuse? The Privacy Rights Clearinghouse, a watchdog group, estimates that more than five million people have been affected by breaches of medical information in the last 18 months. Causes have included the loss of laptop computers and paper records, the posting of data on Web sites, and the curiosity of hospital employees snooping for medical information on celebrities and their colleagues. Interesting, despite the prospect of qualifying for a part of $27 billion in incentives from the federal government, a recent study published online in Health Affairs showed that only about 2% of hospitals had done enough to adopt the necessary elements of electronic medical records to qualify for these future financial incentives.

View from the Flamenco Hotel in Zemalek, Cairo, Egypt

Recently, Oxford bioethicists Julian Savulescu and and Dominic Wilkinson argue that euthanasia coupled with organ harvesting would be an ethicaly appropriate way to obtain more kidneys, livers, and hearts. This point of view “Should We Allow Organ Donation Euthanasia?” was published in Bioethics and since then many blogs have voiced extreme criticisms. Apparently, this idea is not just an idea, as it has already been performed in Belgian where euthanasia is legal, please see: Ysebaert D, et.al. Organ Procurement After Euthanasia: Blegian Experience. Transplantation Proceedings, 2009; 41:585, which describes the experience involving 4 patients who expressed their wish for organ donation after their request for euthanasia was granted.

Question to consider:

How is the process of organ donation after a decision for euthanasia different from the process of organ donation after a decision has been made to withdraw life sustaining treatments from a terminally ill comatose patient?

Recently, Oxford bioethicists Julian Savulescu and and Dominic Wilkinson argue that euthanasia coupled with organ harvesting would be an ethicaly appropriate way to obtain more kidneys, livers, and hearts. This point of view “Should We Allow Organ Donation Euthanasia?” was published in Bioethics and since then many blogs have voiced extreme criticisms. Apparently, this idea is not just an idea, as it has already been performed in Belgian where euthanasia is legal, please see: Ysebaert D, et.al. Organ Procurement After Euthanasia: Blegian Experience. Transplantation Proceedings, 2009; 41:585, which describes the experience involving 4 patients who expressed their wish for organ donation after their request for euthanasia was granted.

Question to consider:

How is the process of organ donation after a decision for euthanasia different from the process of organ donation after a decision has been made to withdraw life sustaining treatments from a terminally ill comatose patient?

Prenatal test for intelligence

As prenatal tests make it possible to identify fetuses that will have mental retardation, deafness, early-onset Alzheimer’s disease and a range of other conditions, such personal deliberations are adding a new layer to the fraught political debate over abortion.

Abortion rights supporters — who believe that a woman has the right to make decisions about her own body — have had to grapple with the reality that the right to choose may well be used selectively to abort fetuses deemed genetically undesirable. And many are finding that, while they support a woman’s right to have an abortion if she does not want to have a baby, they are less comfortable when abortion is used by women who don’t want to have a particular baby.