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August 25, 2015 | Posted By John Kaplan, PhD

One of the great things about scientific knowledge is that it is subject to confirmation or refutation by subsequent research. Science can be confirmed by other laboratories repeating the same studies and finding the same results. However this rarely occurs in the actual course of normally conducted science. In the course of doing science most scientists choose not to simply try to simply replicate the previous study. Rather they consider the findings in the previous study develop the next hypothesis and do a study to extend the findings. Now this seems to be changing.

In 2011 authors from Target Research, a component of Bayer Healthcare, published correspondence in Nature reported that surveys of their internal scientists found “that only in ~20–25% of the projects were the relevant published data completely in line with our in-house findings”. This figure has been widely quoted in the literature but has been transformed into only 20-25% of these research findings were reproducible. There are many problems with this statement and this argument. First it is predicated on the presumption that an appropriate standard for reproducibility is data being entirely “in line” with the work done by internal scientists at Bayer Healthcare. Moreover the studies at Bayer Healthcare, unlike the studies they sought to replicate, were not submitted to the scrutiny of external peer review. There is every reason to consider the possibilities that the fault lies with the replicating studies at Bayer or possibly they did not exactly replicate the studies. We are left to simply accept the word of Bayer without the normal standard of quality that derives from peer review.

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.

August 21, 2015 | Posted By Wayne Shelton, PhD

I love to read novels and works of non-fiction in concentrated sittings so I can really lose myself in what I am reading. Because I am so busy during the course of my work-a-day professional life I rarely have such luxury. This is why vacation for me means a time when I can find a few really interesting books on my reading list and just devour them. Having recently returned from vacation and being overdue for my AMBI Blog, I thought I would share a few thoughts on my vacation reading, and even see if there is a lesson for bioethics.

This summer my reading was unusual in that it was all non-fiction, which included “The Return of George Washington” by Edward J. Larson, “The Warmth of Other Suns” by Isabel Wilkerson, and “Between the World and Me” by Ta-Nehisi Coates. I really didn’t plan to be reading these books together. But as it turns out, after finishing all three, I found a theme of interesting, often disturbing, questions about the past and present treatment of African Americans in the United States—questions that challenge the moral foundation and integrity of American democracy from its origins to the present.

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.

August 19, 2015 | Posted By Zubin Master, PhD

I love reading the news posts in Nature and Science that I receive in the journal’s eAlerts. This past month was most interesting because there were two news posts that I thought were actually a bit contradicting. The first one titled “Spending bills put NIH on track for the biggest raise in 12 years” was published in July of this year and explains how both houses of congress want to increase the National Institutes of Health’s (NIH) annual budget (Kaiser, 2015a). The Presidential branch wants to give the NIH a 1 billion dollar increase while just recently, a Senate panel approved a 2 billion increase. The article also goes onto say that certain programs have been given priority such as the Alzheimer’s research and others like the Agency for Healthcare Research and Quality will receive cuts. Needless to say, I am sure that biomedical and behavioral scientists throughout the country are probably ecstatic. But is this really a good thing?

The other news blurb I read was titled an “A for effort, C for impact from U.S. biomedical research, study concludes” also written by the same author (Kaiser, 2015b). In this article, Jocelyn Kaiser reports the results of a study by two research scientists Dr. Arturo Casadevall and Anthony Bowen who examined publications in the PubMed database and the number of authors, along with the approval of new drugs and their work was published in the journal Proceedings of the National Academy of Sciences (USA). The researchers compared publication outputs with the number of new molecules approved by the U.S. government. What they found was not too surprising. 

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.

August 14, 2015 | Posted By Jane Jankowski, DPS, LMSW

Articles about improving organ donation registration rates by targeted social media campaigns have indicated that such efforts can successfully increase the numbers of individuals who elect to become organ donors (Pena, 2014) (Cameron AM, 2013). While it is acknowledged that social medial is a useful medium for generating widespread recognition of the need for organ donation, concerns about whether or not donor registration actually increases donation rates is left unknown. Additional concerns about such registrations meet the standards for informed consent. These are productive conversations, and social media holds tremendous potential for conveying information and generating levels of interest in topics at a ‘viral’ level.

Discussions up to this point seem to focus on donation after death, or in the context of imminent death. What has not been robustly discussed is the role of social media in the role of live organ donation. How should transplant programs view the relationship of acquaintances that begin on social media in the context of seeking information or support related to organ donation? Decisions to donate a solid organ, such as a kidney, ought not to be undertaken lightly, and perhaps the screening process will weed out donors with ambivalent intent or poor understanding of what they have offered a recipient. Given that concerns about informed consent have been noted in prior studies, it seems prudent to exercise added caution when approving donation transactions initiated via social media outlets.

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.

August 12, 2015 | Posted By John Kaplan, PhD

I have been studying or working in medical schools since 1972. I have seen many changes in that time and not all of it is good. In fact many of the changes I have seen have been for the worse. Among those things that have occurred to the detriment of medical schools in general and mine in particular has been the corporatization of medical schools. Many would suggest that what I am calling medical school corporatization represents a long overdue application of sound business principles and professional management to the operation of medical schools. However, I have seen over and over again, that in reality the major effect of such corporatization has been the distortion and abandonment  of long standing academic values which have allowed education and scholarship to thrive. They have often been replaced with inflexible rule-driven bureaucratic organization driven by the apparent need to control.

Among the reasons that this corporatization has taken place is because of the relationship between medical schools and hospitals. Educational institutions generally have a collegial style of operation with a relatively flat hierarchy. Hospitals, in contrast, seem to be dominated by highly vertical hierarchies with strongly bureaucratic inclinations.  Moreover the educational institutions in these partnerships are generally much smaller than the clinical institutions and the result is dominance of the hierarchical culture at the expense of the collegial academic culture.  The values of education, scholarship and collegiality are threatened and replaced by the values, or in fact lack of values, which spring from bureaucracy.

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.

August 6, 2015 | Posted By Bruce White, DO, JD

Do Americans always need an entire industry to hate or complain about? Big tobacco, big banks, big insurers, big brokerage houses, big oil and energy companies, big automakers, big for-profit hospital companies, big pharma, have all been easy targets in the past. More often than not because of big profits, abuses and excesses, and safety concerns. On July 23, 2015, The New York Times fired another salvo at big pharma when it published Andrew Pollack’s piece titled “Drug Prices Soar, Prompting Calls for Justification.” The article highlights an issue that has been smoldering off and on for years: how do drug companies arrive at prices for their new products? After reading the article more carefully and thinking about the pressured state legislators who are introducing “drug cost transparency” bills, one may wonder why this issue now? The specific trigger this time may be Gilead Sciences’s Sovaldi® (sofosbuvir).

The New York Times has written about the costs of this drug before and how it is straining Medicaid budgets. This may be the most likely reason that these state legislators are asking for drug cost transparency now. The costs of the hepatitis C cure for affected California Medi-Cal patients alone would equal the total education budget for the state.

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.

August 3, 2015 | Posted By Valerye Milleson, PhD

Two notable things happened this past month that I feel compelled to write about: NASA’s New Horizons spacecraft reached Pluto; NASA engineer and managerClaudia Alexander died of cancer. These events highlight some very powerful lessons in bioethics, and indeed about the human condition itself.

Lesson #1: We can do so much.

New Horizons is the first spacecraft to visit Pluto, a mission taking almost ten years (or more, if you count pre-launch), traveling over three billion miles, and costing around seven-hundred million dollars. It will be our first opportunity to truly investigate an ice dwarf planet, and the information gleaned from it holds the potential to complete much of our knowledge of the planetary types in our own solar system. Over eighty years after its discovery by Clyde Tombaugh, Pluto – our final (local) planetary frontier – is within our grasp.

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.

July 28, 2015 | Posted By Claire Horner, JD, MA

As Jane Jankowski, DPS, LMSW discussed in her last AMBI blog posted on June 16, 2015, the proposed rule to reimburse providers for conversations with patients about advance care planning takes a positive step toward educating patients on end-of-life medical considerations by incentivizing doctors to take the time to address these issues in the clinical setting.  Assuming that such reimbursements depend only on raising the topic of advance care planning with patients and not on the content of a patient’s choices (such as whether or not a patient chooses to forego treatment), encouraging health care providers to discuss health care decision making in advance with patients can go a long way to support patient autonomy and provide helpful guidance to surrogate decision-makers when a patient lacks capacity.  Doctors often cite lack of time as a reason why they do not address advance directives in the clinical setting, but this rule would compensate doctors for their time, allowing them more flexibility in allocating time to address these issues.  However, the proposed rule does nothing to ensure that the providers having these conversations are equipped with the proper tools and training to do so.

Advance directives, although they address the provision of medical treatments, are legal documents that can be complex and far-reaching, and therefore are not necessarily self-explanatory to patients or providers.  Many states offer a statutory form advance directive as an example, but all too often these forms may be merely printed by a provider and given to patients to sign without sufficient explanation.  These forms vary in their scope, but some sample living wills, such as forms from West Virginia and South Carolina, are little more than a declaration that no life-sustaining treatments should be provided.  Other states, such asMichigan and Massachusetts, have no law giving legal recognition to living wills at all.  It is possible that patients may be given forms such as these and not understand that they have the option to declare that they wish to receive particular life-sustaining treatments if they are terminally ill.  It is also possible that patients who do not want to limit treatment will decline to sign any advance directive at all, believing that such documents serve only to support a decision to forego treatment at the end of life, and not a decision to receive some or all interventions.  In such situations, merely starting the conversation may not be enough to help patients effectively articulate their wishes, whatever those wishes may be.

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.

July 23, 2015 | Posted By Lisa Campo-Engelstein, PhD

Planned Parenthood recently made national news because an anti-abortion group released an undercover video showing two people posing as fetal tissue recruiters interviewing Dr. Deborah Nucatola, the senior director of medical services of Planned Parenthood. The interview was cropped down into an eight minute clip in which Dr. Nucatola seems to be suggesting that Planned Parenthood sells fetal tissue for profit. Planned Parenthood has responded to the video saying that it is heavily edited and that they do not sell fetal tissue. They do, however, donate fetal tissue with women’s explicit consent and they sometimes receive a small amount of money – in the video Dr. Nucatola says it is typically between $30-100 – that covers transportation of the fetal tissue.

This story made national news because the idea of selling fetal tissue for profit without women’s consent is horrifying. Yet, once we uncover the facts here, this story is much less troubling than it originally seems. One concern the undercover video raises is of selling fetal tissue. It is illegal in the US to sell human and fetal organs and tissue. However, it is not only legal, but also laudable to altruistically donate organs and tissue. Because there is such a strong need for organs and tissue for patients waiting for transportation and for scientific research, there are various campaigns to get people to sign up to be cadaveric organ donors, to donate blood, and to be live kidney donors.  In the US, organ donation is opt-in only, meaning it is completely voluntary and people are under no ethical obligation to donate. Likewise, women who have abortions are under no ethical obligation to donate fetal tissue and typically the fetal tissue is discarded. Women who choose to donate fetal tissue for scientific research are acting altruistically because there are choosing to further scientific research, which could help others in the future.

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.

July 21, 2015 | Posted By Zubin Master, PhD

More and more journals are moving to an open access (OA) platform. OA journals are great because they defer the costs of publication and editorial management onto the researcher and not on readers of journals. There are many advantages to the OA movement. For starters, individual or institutional subscription to expensive journals is not required and OA articles are readily sought, downloaded and cited. There are also advantages to the researchers (authors) of publications, including the potential for greater access, higher citation, and wider circulation. For these and other reasons, many journals are jumping on the OA bandwagon. However, OA is not for everyone because it relies on authors to pay anywhere from several hundred to several thousand dollars. This can be limiting to certain individuals or even fields of researchers. Take bioethics for instance. Bioethicists use conceptual research methods making normative arguments, and they also use various empirical, social science research methods. Most bioethicists do not obtain large research grants that can cover the high costs to publish in OA journals. Bioethicists can perform research without external grant support although having funds certainly helps with empirical research. Moreover, younger investigators who likely have little to no money from grants are at a disadvantage. Usually in biomedical science, there is a culture of grant writing, intra-institutional collaboration for junior scholars to team up with senior investigators who have funds, and support for junior scholars including start-up funds or seed money. Yet start-up and seed money are less common for bioethics researchers beginning their own research programs. The argument I wish to make is that OA and its movement are more geared towards the biomedical sciences where there is a culture and requirement to obtain external grant support and funding, and where research. Obtaining funds for research is certainly not commonplace for bioethics. I am not trying to say that all biomedical scientists have it easier to publish in OA journals; but I just think bioethics, and likely other humanities fields are at a bit of a disadvantage. Without some form of financial support, either from the bioethics department, institution, or external grant funding, bioethicists are at a disadvantage and publish cannot publish in OA journals. And transferring copyright to an OA journal is generally not an option because the philosophy of OA journals is to make articles free for readers and not retain copyright.

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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ABOUT BIOETHICS TODAY
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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