Tag: registries

Bioethics Blogs

We Can and Must Rebuild the Bridges of Interdisciplinary Bioethics

by Darryl R. J. Macer

This editorial is made available on bioethics.net. The editorial along with the target article and open peer commentary is available via tandfonline.com

Although we can argue that bioethics is holistic and found in every culture, and still alive among people of many indigenous communities as well as the postmodern ones, the academic discipline of bioethics as interpreted by many scholars has attempted to burn bridges to both different views and to persons with different life trajectories and training. The bridges between different cultural and epistemological foundations of bioethics have also been strained by the dominance of Western paradigms of principlism and the emergence of an academic profession of medical bioethics.

This editorial reacts to the points made in the article by Lee, “A Bridge Back to the Future: Public Health Ethics, Bioethics, and Environmental Ethics.” This issue of the American Journal of Bioethics (AJOB) includes a number of commentaries on this theme, and challenges readers to reconsider the manner in which they conceive of bioethics, as well as the range of literature and scholars that they consider to as legitimate sources of wisdom. Such a new approach will not only breathe fresh light into the important work of all scholars, students, and teachers, but also offer some fresh references for contemporary policy changes that face us. Let us approach these issues like an ostrich who is taking her head out of the sand after some years of monodisciplinary focus. To be clear, Lee and some others writing here have apparently not had their head in the sand, as the interrelatedness of health and the environment is clear through the examples shared.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Birth Defects Jump Twentyfold in Zika-Hit Mothers: Study

March 3, 2017

(Medical Xpress) – Pregnant women infected with the Zika virus last year were 20 times more likely to bear children with birth defects than those who gave birth prior to the epidemic, US health officials said Thursday. Researchers for the US Centers for Disease Control and Prevention compared birth outcomes prior to the Zika epidemic’s outbreak in 2015—using data from three US state registries—to those of mothers infected by the virus in 2016.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Prescription-Drug Monitoring Cuts Doctor-Shopping for Painkillers

February 22, 2017

(Reuters) – State programs that require physicians to check drug registries before writing prescriptions appeared to slash the odds of doctor-shopping for opioid pain relievers, a new study found. “Our study shows that prescription-drug monitoring programs are a promising component of a multifaceted strategy to address the opioid epidemic,” Ryan Mutter, one of the study authors, said in a phone interview. He is a health economist at the Substance Abuse and Mental Health Service Administration in Rockville, Maryland.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Interactive Map of Advance Directive Laws

The Gitenstein Institute for Health Law & Policy at Hofstra University School of Law has launched a longitudinal, interactive dataset on advance care planning law. 

Users can now interact with this database, presented in the form of a clickable map, to ascertain the parameters of the law in this area in all 50 states from 1970 to the present, including comprehensive coverage of the nature and scope of advance directives in each state, requirements for due execution and revocation, limitations upon pediatric and pregnant patients and persons judged incompetent, POLST and MOLST, and electronic registries.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Call for Papers: KIEJ Special Issue on the 2016 US Election

The Kennedy Institute of Ethics Journal will be publishing a special volume on ethical and social issues arising out of the 2016 US presidential election and the transition to the Trump administration. Papers will be anonymously reviewed and judged according to the scholarly standards typical for the journal, without regard to political orientation. Creativity in form and approach is encouraged.

Among other topics, contributions may explore ethical and social questions concerning:

  • The election and campaign, including campaign propaganda, voter enfranchisement, districting and the electoral college, voter demographics and divisions, ‘filter bubbles’ and media access, etc.
  • The ethical limits and possibilities for protest, resistance, and managing conflict in a divided nation, including questions surrounding the proper place of violence, if any.
  • The rise of nationalist, white supremacist, and Islamophobic rhetoric and activism during this election season.
  • Public allegations of sexual assault, and the politicization of those allegations.
  • The rise of the ‘forgotten white working class’ in reality and in rhetoric.
  • What to expect from a Trump administration, including explorations of his particular proposals (on immigration, Muslim registries, abortion, and so forth).

Papers may be of any length, up to approximately 10,000 words. Short pieces are encouraged.

In order to make this issue timely, we are requesting submissions by February 28, 2017. Papers will be published online and open-access by June 2017.

Please direct any inquiries to Rebecca Kukla, Editor-in-Chief, rk75@georgetown.edu or to Hailey Huget, Managing Editor, kiejournal@georgetown.edu. Papers should be submitted both via the journal’s online submission system and by email to kiejournal@georgetown.edu, with a note saying that they are for the special issue.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

CFP: KIEJ Special Issue on the 2016 Election

The Kennedy Institute of Ethics Journal will be publishing a special volume on ethical and social issues arising out of the 2016 presidential election and the transition to the Trump administration. Papers will be anonymously reviewed and judged according to the scholarly standards typical for the journal, without regard to political orientation. Creativity in form and approach is encouraged.

Among other topics, contributions may explore ethical and social questions concerning:

  • The election and campaign, including campaign propaganda, voter enfranchisement, districting and the electoral college, voter demographics and divisions, ‘filter bubbles’ and media access, etc.
  • The ethical limits and possibilities for protest, resistance, and managing conflict in a divided nation, including questions surrounding the proper place of violence, if any.
  • The rise of nationalist, white supremacist, and Islamophobic rhetoric and activism during this election season.
  • Public allegations of sexual assault, and the politicization of those allegations.
  • The rise of the ‘forgotten white working class’ in reality and in rhetoric.
  • What to expect from a Trump administration, including explorations of his particular proposals (on immigration, Muslim registries, abortion, and so forth).

Papers may be of any length, up to approximately 10,000 words. Short pieces are encouraged.

In order to make this issue timely, we are requesting submissions by February 28, 2017. Papers will be published online and open-access by June 2017.

Please direct any inquiries to Rebecca Kukla, Editor-in-Chief, rk75@georgetown.edu or to Hailey Huget, Managing Editor, kiejournal@georgetown.edu. Papers should be submitted both via the journal’s online submission system and by email to kiejournal@georgetown.edu, with a note saying that they are for the special issue.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Identifying individuals while protecting privacy

Research ethics is complex and requires considering issues from several perspectives simultaneously. I’ve written about the temptation to reduce research ethics to pure protection ethics. Then not as much needs to be kept in mind. Protection is the sole aim, and thinking begins to resemble the plot of an adventure film where the hero finally sets the hostages free.

Protection is of course central to research ethics and there are cases where one is tempted to say that research participants are taken hostage by unscrupulous scientists. Like when a group of African-American men with syphilis were recruited to a research study, but weren’t treated because the researchers wanted to study the natural course of the disease.

Everyday life is not one big hostage drama, however, which immediately makes the issues more complex. The researcher is typically not the villain, the participant is not the victim, and the ethicist is not the hero who saves the victim from the villain. What is research ethics in everyday situations?

There is currently a growing concern that coding of personal data and biospecimens doesn’t sufficiently protect research participants from privacy invasions. Hackers hired to test the security of research databases have in some cases been able to identify the individuals who provided their personal data to research (in the belief that the link to them had been made inaccessible to outsiders through advanced coding procedures). Such re-identified information can obviously harm participants, if it falls into the wrong hands.

What is the task of research ethics here? Suddenly we can begin to discern the outlines of a drama in which the participant risks becoming the victim, the researcher risks becoming the villain’s accomplice, and the ethicist rushes onto the scene and rescues the victim by making personal data in research databases completely anonymous, impossible to identify even for researchers.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Forgotten Stories of the Eugenic Age #5: Creating Super-People

The Birth of Venus by Sandro Botticelli, 1480s

[Forgotten Stories of the Eugenic Age is a blog series exploring the lesser-known ways that eugenics affected and engaged American lives during the first half of the twentieth century.]

“Can science produce a superman?” science writer Waldemar Kaempffert wondered in the New York Times in 1928. “What kind of a superman do we want? And who shall dictate his specifications?”

In the early twentieth century, new genetic discoveries prompted supporters of eugenics to ponder the potential creation and characteristics of a superior human race. Many believed that encouraging the eugenically “fit” to mate and isolating or sterilizing the eugenically “unfit” would yield over time a superior population. They argued that breeding a better race represented the next step in human evolution. After all, careful husbandry had improved crops and livestock. Surely the production of “human thoroughbreds” could not be much different.

“Scientific” Creation
With new scientific knowledge and technologies, eugenists believed that they at last had the tools to create improved people. They were particularly interested in developing technologies for assisted reproduction, including the human application of animal husbandry techniques like artificial insemination. Dr. Julian Huxley, grandson of champion of the theory of evolution T. H. Huxley, predicted that such techniques would allow eugenically fit men and women to marry whomever they chose, but—regardless of their partners’ fertility—have children with third parties who had been specially selected for their genetic qualities. (Those who might object to this cold calculation were merely exhibiting “outworn sentimentalism,” said Huxley.)

Exhibiting similar thinking, Dr.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

BIOETHICSTV: House of Cards Shuffles The Deck on Organ Allocation

by Craig Klugman, Ph.D.

BioethicsTV is an occasional bioethics.net feature where we examine bioethical issues raised in televised medical dramas.

This past weekend I was binging on House of Cards, season 4. Although this is not a medical drama, a story arch this season is relevant to this column.

If you have not watched yet, please be warned that this post is a big spoiler. Read no further if you care about such things.

One of the storylines this season is about President Underwood being shot and most of his liver removed. The doctors hope that the organ will regenerate but it does not. Doug Stamper, his chief of staff, searches for information on being a live organ donor and when he does volunteer, the doctors tell him that Underwood is too far gone for a partial organ; he needs an entire new liver. What is not discussed because no testing occurs is that Stamper is a recovering alcoholic.

Being the President does not give you much of a leg-up on the organ waiting list, according to Cards and in real life. More simply, the computer algorithm that allocates organs would have no knowledge that a patient is the President. Social worth criteria are absent from the computer system, though such considerations often are taken into account when a transplant center decides whether to put a patient onto the list in the first place.

But in the Cards universe, Underwood is very sick and is number 3 on the list. Stamper makes a visit to the Secretary of Health and Human Services who shows Stamper that the President is now number 2 on the list, because the first person received an organ.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

10 years after Vioxx scandal, pharmaceutical companies caught again misleading patients using false claims

Pharmaceutical companies have once again used industry influence to conceal data and make false claims about a high-profile medication.

Today The New York Times reported that Johnson & Johnson and Bayer – the companies behind the anti-clotting drug Xarelto – are responsible for critical laboratory data being left out of a letter published in The New England Journal of Medicine discussing the safety of the medication. Lawyers representing patients suing the two major pharmaceutical companies claim that both corporations were complicit by remaining silent about the data concealed from the publication.

If this scenario sounds familiar, it’s because it is: in 2005, The New England Journal of Medicine published an Expression of Concern after it was discovered that researchers had deliberately concealed three heart attacks in the data from a clinical trial of the painkiller Vioxx (which has subsequently been taken off the market).

As a response to this serious breach of ethics, Fordham University’s Center for Ethics Education held a conference in January 2005 entitled, “Bio-Pharmaceuticals for the 21st Century: Responsibility, Sustainability & Public Trust.” This conference resulted in a white paper on clinical trial registries and results databases that helped to pave the way for legislation requiring pharmaceutical companies to disclose the results of studies.

Following the conference, Center Director Dr. Celia B. Fisher published an article in Science arguing that while hasty legislation mandating posting of results to ensure public safety is necessary, “results databases are not a substitute for systematic scientific peer review and scientific rigor.”

While the recent clinical trial results published on Xarelto indicate that the pharmaceutical companies have found a workaround to the updated policies, it is important to revisit the ethical issues Fisher raised more than a decade ago.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.