February 5, 2016 | Posted By Bruce White, DO, JD

An article that appeared in the Journal of the American Medical Association on January 4, 2016, written by Johns Hopkins Institute of the History of Medicine and Bloomberg School of Public Health professors Jeremy A. Green, Gerard Anderson, and Joshua M. Sharfstein recommended that the Food and Drug Administration (FDA) act to improve access to approved generic drugs that are becoming scarce because of a lack of competition. It’s surprising that respected historians and health policy educators believe that the FDA should have any such governmental role. As highly regarded as they are, the authors appear neither to fully understand FDA and drug regulation history or health care delivery competition oversight. The FDA has never had statutory authority to regulate drug prices, period. And, they rightly shouldn’t have.

The FDA exists to protect the public safety, health, and welfare by assuring that drugs marketed in the US are safe and effective. The reasonableness of the prices for these drug products is of no concern to the FDA as a regulatory body. In the general scheme of federal oversight, fair business and trade practices are the responsibility of the Federal Trade Commission (FTC) and the Civil and Criminal Divisions of the Department of Justice. These governmental authorities are responsible for the enforcement of the anti-competition and antitrust laws. The FDA has enough to do already; drug pricing should be left in the regulatory hands that are charged with this duty without involving the FDA. There’s no real value of involving the FDA here, except perhaps to muddle the waters more.

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.

February 2, 2016 | Posted By Jane Jankowski, DPS, LMSW

Since 2001, the Health Insurance Portability and Privacy Act (HIPPA) has been in place to provide assurances that private health information would be protected and to offer standards for disclosing person health information. Despite accountability to federal standards, serious breaches still occur. What is surprising is how often such missteps take place despite such safeguards, and why. 

HIPPA is characterized by the Department of Health and Human Services as follows:

“The HIPAA Privacy Rule establishes national standards to protect individuals’ medical records and other personal health information and applies to health plans, health care clearinghouses, and those health care providers that conduct certain health care transactions electronically.  The Rule requires appropriate safeguards to protect the privacy of personal health information, and sets limits and conditions on the uses and disclosures that may be made of such information without patient authorization. The Rule also gives patients rights over their health information, including rights to examine and obtain a copy of their health records, and to request corrections.” 

The implication is that there are serious consequences for breaches in privacy that either intentionally or unintentionally discloses private health information without permission from the patient. And this is sometimes true, but not as true as we might expect. Major security breaches at national insurance carriers or healthcare centers are likely to make the national news reports, however, individuals who experience unauthorized disclosures of private health information are finding they have little recourse. 

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.

January 28, 2016 | Posted By Claire Horner, JD, MA

Gestational surrogacy contracts have been in the news again recently as a gestational surrogate reports that the intended father, having discovered that she is expecting triplets, is demanding that she undergo selective reduction to abort one of the fetuses.  Situations such as these, while often not reported, are not necessarily uncommon.  In 2013, a gestational carrier was offered $10,000 to abort when a second trimester ultrasound discovered congenital heart and brain abnormalities.  Despite a well-established Constitutional right to privacy that includes a pregnant woman’s right to procure – or refuse – an abortion, surrogacy contracts routinely include provisions that not only prohibit a surrogate from having an abortion unless there is a medical need, but also give the intended parents sole discretion to determine whether the surrogate should abort where there is evidence of a physical abnormality or other issue.  Such provisions have not been tested in court, but would almost certainly be unenforceable based on the surrogate’s Constitutionally-protected right to reproductive autonomy.


In India, where there is an estimated $400 million surrogate tourism industry, women agree to be surrogates in exchange for $5,000-7,000, which is far more than they could make otherwise.  In many clinics, surrogates live in dormitories for the duration of the pregnancy and their food and medical care is provided by the clinic.  There are also reports that some clinics have policies against pregnancies of 3 or more fetuses – meaning that selective reduction may occur as a matter of course to reduce the number of fetuses to 2 or 1.  If this is in fact happening, are the surrogates (or even the intended parents) aware of what is happening?  Are they given a voice in the medical care and treatments they receive?  Or are the decisions made by the intended parents or the clinic, and simply imposed on the surrogate?


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.

January 25, 2016 | Posted By John Kaplan, PhD

I recently posted an article on our Facebook page about pharmaceutical company CEO Martin Shkreli being arrested for securities fraud. You will remember that this is the same character disabled CEO of Turing Pharmaceuticals who was in the news very recently for price gouging, having increased the price of the anti-parasitic drug Daraprim from $13.50 to $750. But you know all of that. What has fascinated me is that when I posted the article about his arrest on the Alden March Bioethics Institute Facebook page it reached nearly a thousand people in a few hours. That is a lot of people for the Alden March Bioethics Facebook page. I pondered why this would happen. Why were more people interested in Martin Shkreli that in all of the postings we make regarding what seem to me to be fascinating bioethical topics?

Obviously I do not know exactly why this is. But this is a blog, not a scientific paper and that means that I am free to guess why that is. It probably is not that his name starts with four consecutive consonants although that is somewhat disconcerting. The first piece of evidence to be considered is what other articles are prominent in the online news outlets next to the article about Martin Shkreli. I see that on the same CNN page which features news on our boy wonder pharmaceutical company CEO and hedge fund whiz kid other articles about a police manhunt for the so-called Affluenza Teen and about Donald Trump and Vladimir Putin lauding each other with praise. I see it next to an article about Virginia schools closing over the outrage about a homework assignment in a world geography class concerning Islam, an article about a Kuwaiti airline that will not fly Israelis, and a gang-rapist being freed in India. To me the commonalities of these featured stories are clear. They are all about people who seem to love to hate. And we seem to enjoy, or at least be fascinated about, finding people and things to hate. There seemed to be little on the page offering things or people to like and certainly nothing about things or people to love.  I find this very ironic, especially during this holiday season. (Some people will probably also hate my use of the word ironic which seems rarely used correctly.)

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.

January 22, 2016 | Posted By Wayne Shelton, PhD

Normally, and rightly so, we take ethics far more seriously than we do etiquette.  After all ethics deals with what we take most seriously that relates to the good life, what we hold dear, our commitments to each other and ourselves, and all that is important to human life. From the Pre-Socratic thinkers forward, thinking about how we should live in order to achieve happiness and well being as a human being has been a theme of philosophical ethics, and still concerns us today in bioethics and clinical ethics. 

Etiquette on the other hand, deals with more superficial matters, such as how our actions appear to others, and whether or not they conform to common social standards for acceptable behavior. Etiquette then, at a minimum, pertains to a world of appearances and social custom, more of what someone is on the outside, not on the inside. 

No wonder we usually take etiquette less seriously, or should, than we do ethics. Many of us may enjoy someone showing a bit of irreverence toward social custom from time to time, especially if the social context is overly rigid and unforgiving. At times such irreverence can be not only humorous, but also important. But I want to argue that in general a certain amount of conformity to standards of etiquette is essential for any functioning 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.
January 20, 2016 | Posted By Zubin Master, PhD

There have been dozens of papers in the past few years about our current biomedical science enterprise being unsustainable, starting with a prominent paper by Bruce Alberts, Marc Kirschner, Shirley Tilghman and Harold Varmus in 2014. They and others argue that the biomedical science environment is unstainable given its current growth and has led to a hypercompetitive environment where innovation has declined while possibly other factors have worsened such as authorship ethics, cutting corners, and the irreproducibility of results. There is tons of data from the NIH, NSF and academic researchers demonstrating the low rate of success in obtaining grants, longer post-docs, and less faculty level job opportunities, yet we continue to increase the number of students accepted into PhD programs. What are we going to do with the overflow of PhDs?

A recent article by Julie Gould in Nature writes about this topic. To summarize, she and others come up with several solutions of which I will discuss a few.

The first, and perhaps the most difficult for researchers and institutions to swallow, is simply reduce the number of PhDs (the entry rate). I and others have indicated that we need to decouple the labor from the training function of PhDs. Currently, PhDs and post-doctoral fellows are the labor backbone for the biomedical research workforce. Principal investigators (PIs) use PhDs as cheap labor to undertake research within their grants. The problem I think can be easily resolved if NIH was to set limits on the number of students which can be recruited for different types of NIH grants, or if academic institutions and graduate departments limit the number of PhDs they enroll. Yet there is really no appetite for such a policy shift and enormous resistance. Some argue that fewer PhD scientists could send a message that perhaps going into science is not the best vocation one can enter or that it may reduce scientific imagination overall. I’m not sure if this is a worthwhile reason to maintain the growing number of PhDs in biomedical science.

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.

January 14, 2016 | Posted By Jane Jankowski, DPS, LMSW

“Of all the ways to be wounded,” regrets Jake from Ernest Hemingway’s novel The Sun Also Rises, setting the stage for a narrative which implies the male character’s war injury to his genitals rendering him irreversibly and torturously impotent. Recently, the NY Times reported that research on penis transplants would offer a possible treatment option for men who have suffered injury to the groin in war or other trauma (www.nytimes.com-heal-troops).  To attempt to restore function and procreative ability cadaveric penis transplants will be undertaken as an experimental procedure. As noted in the article cited above, consent from donor’s family would be secured as with any organ donation. While some may find such surgical interventions to be less compelling than other transplants which provide life- saving organs (heart, lung, kidney, liver, pancreas) transplanting reproductive organs offers important benefits to patients.   

Uterine transplants have been discussed in the media recently, and seem to hold promise as these transplants have been done successfully in Sweden(www.nytimes.com-uterus-transplants ). Women born without a uterus may soon be able to receive a cadaveric uterus in the US. Unlike penis transplants which rely on exclusively cadaveric donation, live donation has been performed for uterine transplants in Sweden, and in time may also be available for women in the US.

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.

January 12, 2016 | Posted By Bruce White, DO, JD

As is their publishing practice, the American Journal of Bioethics recently invited submissions for an Open Peer Commentary to an article they plan to publish in the next few months. The article is entitled “A Pilot Evaluation of Portfolios for Quality Attestation of Clinical Ethics Consultants” and authored by Joseph J. Fins, MD, Eric Kodish, MD, and the other members of the American Society for Bioethics and Humanities (ASBH) Quality Attestation Presidential Task Force (QAPTF). This paper is a sequel to their earlier paper “Quality Attestation for Clinical Ethics Consultants: A Two-Step Model from the American Society for Bioethics and Humanities” which was published in The Hastings Report. [http://www.ncbi.nlm.nih.gov/pubmed/24092588] The first paper described the ASBH plans to “attest” to the “quality” of self-identified, randomly-selected pilot clinical ethics consultants who submit a “portfolio” illustrating their consultation activities. When the article appears, all involved in clinical ethics consultation and the training of future clinical ethics consultants should read the paper. The QAPTF and the ASBH should be congratulated for doing this work and sponsoring the activity.

However, in thinking through this process again, one wonders how much of this is about the past and not about the future. Shouldn’t any process be more prospective and less retrospective? Maybe this is not possible? But how important is it really to show that people who are currently offering clinical ethics consultation services and recording their efforts in portfolios for other “experts” to review and compare do their consultations satisfactorily? Will this “attestation” somehow change their employment or practice circumstances or patterns? Will their employers dismiss them if they fail to obtain “attestation” status and hire clinical ethics consultants are meet the attestation standard? Will it add public recognition? In truth, is “attestation” really a quality standard that matters?

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.

January 7, 2016 | Posted By Wayne Shelton, PhD

Alzheimer’s is a progressive disease that over time robs the person of their selfhood. Eventually the advanced Alzheimer’s patient lives in a world of discrete, fleeting moments. The former self is obliterated and all of the personal connections to former loved ones are forever lost. The current self or the “now-self” is self-contained in each passing moment so there are as many selves as there are moments. From the onset of diagnosis a patient may live for as few as 3 years to as many as 10 or more. Much depends on the age of the patient and the comorbid conditions. But it is important to make clear: Alzheimer’s is a terminal disease for which there is no effective treatment to abate the progressive symptoms or to prevent or slow the mental and physical dying process. Though death does not occur until the whole human organism ceases to function, death must also, at least partly, be understood as the gradual dying of that unique personal self. This includes the higher brain functions that allow humans to be their uniquely personal selves, with personalities, habits, loves, careers, causes, values, characters, and so on. When these aspects of the patient begin to wane, there begins the gradual loss of “critical interests”—those personal aspects of one’s life one controls as an autonomous, social human being and moral agent.

Yet, the loss of critical interests or what we might call rational selfhood, do not necessarily entail the simultaneous loss of “experiential interests” that are connected to purely biological functions.  The Alzheimer’s patient may continue to have a robust interest in food, drink, music, social interaction (even without recognizing the person with whom she is interacting), sex, and so on. Patients with robust experiential interests but no critical interests may eat hearty meals and be social in very new ways, sometimes with intimacy, with people they never knew before. But at some point in the course of the disease, even those experiential interests begin to wane and eventually disappear. At that point, patients with Alzheimer’s no longer are able to feed themselves or care for themselves in any way. In fact they may be totally puzzled having food in their mouths, not knowing how to chew and swallow, or having to go the bathroom. They live in a world where they cannot comprehend what is happening to bodies. For many, the possibility of losing all of one’s critical interests as a human being and being left with only experiential interests is terrifying. So how does one plan one’s own medical care during this time?

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.

January 4, 2016 | Posted By Valerye Milleson, PhD

"I now know that if you describe things as better as they are, you are considered to be romantic; if you describe things as worse than they are, you are called a realist; and if you describe things exactly as they are, you are called a satirist." – Quentin Crisp

A theme that has run through many of my blog posts so far is the concept of eudaimonia. This New Year, which not only highlights the annual rituals of goal setting and actively plotting to become the best person you can be in the year to come but also is a reminder of the birth of famed raconteur and master of wit, Quentin Crisp, seems to me like the perfect time to discuss this concept in greater detail.

"If I have any talent at all, it is not for doing but for being." – Quentin Crisp

Despite his humble self-description, Quentin Crisp has been a hero to many, and in his vocation of being he was one of the strongest advocates of “living well” in recent times. Living well (or “good spirit”, happiness, human flourishing, etc.) is roughly what ancient Greek philosophers meant by eudaimonia. Aristotle’s definition in the Nicomachean Ethics of “living well and doing well” (Book I, Chapter IV) is apt and fairly uncontroversial; but it is far from self-explanatory. After all, “living well” can mean different things to different people. For Aristotle, living well basically meant living a life of excellence in reason (along with certain external goods necessary to keep this virtuous activity going smoothly). The Stoics agreed with Aristotle’s account on the role of excellence in reason, but disagreed with him about the importance of such things as wealth, family, friends, power, beauty, etc. in one being able to achieve eudaimonia. The Cynics and the Stoics held fairly similar views of eudaimonia, but in general the Cynics seemed to actively disavow these external things, and living well to a Cynic would have been more akin to the life of a virtuous ascetic. The Cynics also tended to be, like Mr. Crisp, satirists, cosmopolitans, and lovers of excellence and humanity.

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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