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October 6, 2014 | Posted By Bruce D. White, DO, JD

The September 24, 2014, issue of USA Today carried a story titled, “Anti-Addiction Groups Want FDA Chief to Resign: Activists Say Agencies Policies Have Led to Epidemic of Painkiller Abuse.” The first sentence of the news report says: “Anti-addiction activists are calling for the Food and Drug Administration’s top official to step down, saying the agency's policies have contributed to a national epidemic of prescription painkiller abuse.” ABC News reported the story that same day with the lead, “Anti-Addiction Groups Call for New FDA Chief.” In the written ABC News commentary, the hype may be characterized in one inflammatory sentence: “In a letter released Wednesday, more than a dozen groups ask the Obama administration’s top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009. The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called Zohydro [ZOHYDRO™ ER (hydrocodone bitartrate) extended release capsules, Zogenics, Inc.)], against the recommendation of its own medical advisers.” Both the print and newscast reports came from an Associated Press report written by Matthew Perrone about a controversy that has been brewing for sometime. The activists’’ letter to Secretary of Health and Human Services Sylvia Burwell is available online and states their position clearly. 

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 3, 2014 | Posted By Paul Burcher, MD, PhD

I was at a conference last week in medical ethics, and I was surprised by, or perhaps appalled at, the attitude displayed by many of the philosophers regarding the importance of medical knowledge in medical ethical decision making. Several of them proudly announced a total ignorance of the medical issue they were speaking on, and also showed no interest in what I would call “real world” implications of their conclusions.  Although I have a PhD in philosophy, I am not a philosopher in the sense that I am capable of, or interested in, spinning arguments from “thin air” with no grounding in medical facts, and no implications for real medical practice.  Medical ethics must begin in real life issues and problems, and end with equally real and meaningful conclusions that can be applied, and sometimes even empirically tested. 

This is not to say that philosophers cannot make good, or even great, medical/clinical ethicists. But they need to begin with a healthy respect for the way in which the “facts on the ground” inform the ethical decision-making.  A brief example illustrates my point.  In Hilde Lindemann Nelson’s famous article explaining narrative ethics, she discusses the case of Carlos and Consuela. Carlos is an HIV positive gang member wounded in gang violence, who is recovering from his injuries in a hospital.  He is now ready for discharge, but needs dressing changes at home.  He wants his sister Consuela to do the dressing changes, but he insists that she not be told about his HIV status.  While Dr. Lindemann Nelson uses this case to make several excellent points about the limitations of principle based ethics, one aspect of the question, crucial to any ethical reasoning on the case, is obviously the transmissibility of HIV infection through dressing changes.  This “fact” is an essential aspect that underpins any ethical judgment regarding the case.  The conflict between patient confidentiality and duty of nonmaleficence (toward Consuela) pivots in part on the fact that HIV is not readily contagious, and simple universal precautions should make the risk to Consuela essentially nil.

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 2, 2014 | Posted By Jane Jankowski, DPS, LMSW

Who decides when a problem is worthy of clinical attention? Symptoms may prompt individuals to seek medical attention, but part of this recent review of the Prozac revolution (selling-prozac-as-the-life-enhancing-cure-for-mental-woes )in the US suggests that public perception of medication for some problems was launched into a new era when Prozac hit the market in 1987. Truly revolutionary in its ability to target serotonin in order to treat depression, the additional impact of rolling out Prozac was the perhaps unintended consequence of marketing drugs to address issues which enhance people’s daily life.

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.

September 25, 2014 | Posted By Lisa Campo-Engelstein, PhD

One of the more controversial parts of the Affordable Care Act (ACA) is the mandate that insurance companies cover contraception. As seen in the Hobby Lobby case, the argument is often boiled down to two conflicting sides: women who want the right to receive contraception without a co-payment and employers don’t want to provide contraception due to their religious convictions. Men’s right to receive contraception without a co-payment is missing from the ACA and the larger debate about the right to contraception. I wonder, however, how this public discussion would be different today if there were more types of male contraceptives and men were expected to assume more responsibility for contraception. 

It is worth noting that women’s association with contraceptive responsibility is a relatively recent phenomenon. Before the “contraceptive revolution” of the 1950s and 1960s, which lead to the development of hormonal and long-acting contraceptives, notably the pill, men actively participated in many forms of contraception. One reason for this is that contraceptive use was tied to the act of sex itself or to the timing of sex; therefore men had to be involved. All of the available contraceptives were used during sex, such as condoms, diaphragms, sponges, and withdrawal; immediately following sex, like douches; or were related to the timing of sex, as in the case of the rhythm method. 

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.

September 23, 2014 | Posted By Zubin Master, PhD

What is the role of public education and stem cell tourism? What type of education is available to patients, caregivers and the public? Can public education actually change people’s minds such that they won’t undergo an unproven stem cell-based intervention (SCBI)? These are the questions I will discuss here. But first, let’s just give a brief description of stem cell tourism and outline some of the proposals discussed to stop this industry.

The “Stem Cell Tourism” Industry and Ways to Curtail the Market

Briefly, “stem cell tourism” is a term used to describe an Internet-based, direct-to-consumer advertised industry where patients receive unproven SCBIs for a range of diseases and injuries. Many clinics offering unproven SCBIs are in countries with lax regulations and enforcement. However, these clinics are also increasingly popping up in highly regulated countries like the U.S., U.K. and Australia. The term “stem cell tourism” is misleading because patients may not necessarily need to travel a great distance to receive such interventions, and focuses on patient behaviors instead of others involved in this market including regulatory agencies and the providers offering them. Moreover, there are some real risks to stem cell tourism. Beyond patients being financially exploited, there are several reports of tumors, lesions, tremors, other problems, and even deaths of individuals receiving unproven SCBIs. And there seems to be a stem cell “treatment” for just about every disease and injury, no matter how severe or benign if the patient can pay anywhere from $8,000-$30,000. Clinics advertise for serious conditions such as heart disease, stroke, MS, Parkinson’s disease, ALS, and spinal cord injury among many others. You might have also heard of major NFL stars receiving SCBIs for sports injuries, movie stars receiving anti-aging stem cell treatments, and even a U.S. Governor receiving stem cells for chronic back pain. The fact that celebrities and public figures are receiving untested SCBIs is likely to make it seem that they are safe and effective and only bolsters the market. Yet there are very few bonafide stem cell treatments out there. While more clinical trials using stem cells are underway (1), it will become increasingly difficult for patients to discern between a legitimate clinical study and a fraudulent intervention. And because of all the hype, ethical issues, and misconduct scandals having to do with stem cell research, having patients become injured due to an unproven SCBI is not only bad itself of course, but also can seriously stifle the stem cell field.

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.

September 19, 2014 | Posted By Ricki Lewis, PhD

In recent weeks, there’s been talk of three types of genetic testing transitioning from targeted populations to the general public: carrier screens for recessive diseases, tests for BRCA mutations, and non-invasive prenatal testing (NIPT) to spot extra chromosomes in fetuses from DNA in the maternal bloodstream.

Are these efforts the leading edge of a new eugenics movement? It might appear that way, but I think not.

When I began providing genetic counseling 30 years ago at CareNet, a large ob/gyn practice in Schenectady, NY, few patients were candidates for testing: pregnant women of “advanced maternal age” (35+), someone with a family history of a single-gene disorder or whose ethnic background was associated with higher prevalence of a specific inherited disease. Their risks justified the cost and potential dangers of the tests.

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.

September 16, 2014 | Posted By Wayne Shelton, PhD

Ok, I realize I am being somewhat provocative. But there is a real and very serious issue, which I am groping to address in a more precise manner.

In my last blog I described the contemporary moral setting from a philosophical perspective as one in which no single substantive normative moral perspective can resolve moral questions, such as the boundaries of human life and the scope of individual rights, with final moral authority. This is just to say, more simply and obviously when we reflect upon it, that in democratic, secular America, ethics, both philosophically and practically, becomes inextricably linked to public discourse in politics and public policy.

When bioethicists ask questions and make arguments about abortion, physician assisted suicide, stem cell research and cloning, and many other similar issues that pertain to questions about the value of human life in relation to both individual rights and societal goals, we have no privileged moral authority from which to draw. As bioethicists we engage in procedural, persuasive discourse, based on conventional moral principles that most often conflict, which is why there is moral dilemma or problem requiring analysis and prioritization. Our purpose in defending a particular moral position is to win assent from others. In short, for a bioethicist to promote a moral position, it is implicitly an attempt to build a consensus among readers and listeners that will hopefully impact public opinion about a particular moral problem or question. Moreover, to the extent these questions have public policy ramifications, and practically all do, it means that moral discourse is also oriented to effect change and function as a medium in which bioethicists often speak as advocates about how moral options should be framed as public policy positions in a democratic society. 

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. 

September 11, 2014 | Posted By John Kaplan, PhD

The answer, it seems, is quite a number of people. The question that we really need to address is why. Are these concerns rational, are they science based, should they provide the basis for public policy? People have been using selective breeding and hybridization techniques for thousands of years to alter the genetic makeup of both plant and animal agricultural products. Neil Tyson Degrasse made the point very clearly and effectively that almost nothing we grow agriculturally has been unchanged from the plants and animals living naturally. They have all been altered by the intentional action of human beings. Selective breeding, of course, has significant differences from what is currently characterized by the term genetic modification which is done using the techniques of molecular biology to insert genetic material. But they do establish the principle that most people are happy to eat food products which have been genetically altered by people. That sweet red apple you had for lunch or the fattened cattle which produced your juicy hamburger do not exist in nature.

The techniques of genetic engineering which can be used to insert genetic material into the genome of a cell permitted the alteration of crops that resist pests requiring less use of pesticides. They allow selective herbicide resistance allowing the use of minimally toxic or nontoxic  herbicides as well as no till farming which diminishes erosion and reduces use of fossil fuels. They have also been able to use these techniques to add essential nutrients to address widespread dietary deficiencies. An example of this is the development of golden rice, the genetic modification of rice to produce vitamin A. These are good things.

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. 

September 9, 2014 | Posted By Bruce D. White, DO, JD

On August 30, 2014, cardiovascular drug researchers managing the PARADIGM-HF Study and its Committees announced that they were terminating their Phase III trial of LCZ696 because of observed “overwhelming benefit.” As reported in The Daily Mail: “Thousands of lives could be saved by a new drug for heart failure that researchers claim outperforms the current best treatments. … Research on more than 8,000 patients found that it saved 20 per cent more lives than the current ‘gold standard’ treatment – the ACE inhibitor enalapril.” The findings were announced at the annual meeting of the European Society of Cardiology and published the same day in the The New England Journal of Medicine. In a news release, the Switzerland-based Novartis International AG – the drug manufacturer sponsor – said that it would submit an FDA application to market the drug in the US by the end of 2014. Novartis anticipates submitting a similar application to the European Union by early 2015.

Analysts say “that [the new drug] might cost $7 a day in the United States, or about $2,500 a year. Existing [standard] drugs are generic, costing as little as [$48 a year] … .”

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.

September 4, 2014 | Posted By Luke Gelinas, PhD

There has been a good bit of debate lately in bioethics circles over the concept and proper definition of death.   The disagreement is between those who think that the cessation of brain activity or ‘brain-death’ is sufficient for death, on the one hand, and those who think that brain-dead patients whose circulatory systems continue to function are still alive, on the other.  Consider, for example, the recent tragic case of Jahi McMath.  McMath suffered complications from a surgery to correct sleep apnea which resulted in cardiac arrest and her being placed on a ventilator.  Shortly after physicians at Oakland Children’s Hospital pronounced her brain-dead and so legally dead.  Her family, however, disagreed, and appealed to the courts for Jahi to be maintained via mechanical ventilation and PEG tube.

Although Jahi’s family disagrees with the claim that she is brain-dead (insisting that she is merely ‘brain-damaged’), suppose the Oakland physicians are correct in their diagnosis of brain death.  Nonetheless, even after the pronouncement of brain-death Jahi’s body continued to exhibit the sort of homeodynamic equilibrium—at least for the time being, and with assistance from mechanical ventilation and other life-sustaining interventions—characteristic of living organisms.  It was warm to the touch; her heart continued to pump blood through her veins; and so on.  Indeed the bodies of brain dead patients have in some cases remained functional for weeks and even months, performing such surprising feats as undergoing puberty and even gestating fetuses. This has led certain physicians and philosophers to question whether brain death is really sufficient for death.  Patients who are truly dead, after all, could not be warm to the touch or gestate fetuses.  Could they?  

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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