Tag: government

Bioethics Blogs

Politics of Pain: Investigating the Ethics of Palliative Care as a Global Human Right

by Alix Masters

Within the last decade, strides have been made in the field of global health policy to extend the reaches of palliative care universally.  In 2014, the World Health Organization formally declared palliative care a global human right.[1] This development in global health policy is a positive one when we consider the medical politics of pain relief across racial difference.  Both in the United States and abroad, there is a long medical history of discriminatory practices against certain groups of people with regard to pain management—including withholding necessary pain medication altogether.  Therefore, in many ways the declaration of palliative care as a human right is a necessary step in ensuring all peoples, regardless of identity, have their pain taken seriously by the medical establishment and have their comfort made a medical priority.  When we consider how different cultures negotiate beliefs around death and pain relief, however, the issue of palliative care as a universal human right becomes more complex.  For example, countries with strong histories of Buddhist thought and culture have traditionally opposed the ideology of palliative care.[26]  In Buddhism, suffering is considered an inextricable part of life and masking this suffering through medical intervention is looked down upon.[2]  For example, Vietnam, a country with a culture strongly imbued with Eastern Buddhist values, has a long history of rejecting palliative care and pain medications in general.[26]  Due to this, the World Health Organization’ declaration that palliative care is a universal human right could also be understood as a Western organization blatantly ignoring Buddhist cultural traditions.  While the declaration of palliative care as a human right is important progress in many ways, it is also important that Western medicine not impose our values globally without consideration for the complex histories and belief systems of diverse cultures.

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

Harvey and Irma: Bioethics in Natural Disasters

by Craig Klugman, Ph.D.

This is a time of disaster. Last week Hurricane Harvey devastated Southeast Texas, a place where I did my doctoral studies. This week we are awaiting Hurricane Irma, the strongest hurricane to head toward South Florida in 25 years. My family lays in the path of that coming storm. I first became interested in natural disaster in 1989 when my college campus was jolted by a 7.1 earthquake in Northern California.

Bioethics has a role in responding to and preparing for these natural disasters. Most every state, large city and county, and most hospitals have been working on crisis standards of care plans. In 2009 and again in 2012, the Institute of Medicine recommended governments to undertake such planning. Many of us working in bioethics have been involved in these efforts. More specifically, we have been involved with developing ethical frameworks for decision-making, policy-making, and operations during emergency planning.

I worked with Texas during its planning for pandemic flu and for the last 3 years have been part of the ethics subcommittee of Illinois’ workgroup, most recently as chair. Similar groups have produced excellent reports in many places such as Delaware, North Carolina, Michigan, Minnesota, Tennessee, Texas and Toronto. They offer guidance and justification for a varied set of guiding principles and ethical frameworks. All of them hold certain core ideals in common.

First, all of the reports agree that transparency and open communication is essential. Planning needs to involve not only government officials, but also community members.

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

A Modest Proposal

FDA should regulate digital games, and potentially other apps, as medical devices.

Why, pray tell?

One doesn’t have to look very hard to find a growing belief (recognition?) that video games are addicting.  CBS has been on the story since at least 2007.  In 2014, “60 minutes” suggested that a violent video game could prompt murder.  Well, they posed it as a question, but to raise it as they did sounds kind of like asking someone, “have you stopped beating your wife?”  And this past April, they did a piece with a former Google employee who suggested that tech companies are designing games, if not apps in general, to draw people into compulsive use.  They revisited the topic, with the same interviewee, in June, using the term “brain hacking.”  Frontline on PBS did a series on the topic in 2010, looking at concerns about internet addiction as well as arguments that some games may hone desirable skills.

Concern about the effect our entertainment media have on us, especially on our kids, is certainly not new.  Remember Tipper Gore, who, among other things, wrote a book about the subject 30 years ago?

The difference comes if our apps and games are not just addictive and self-reinforcing, but if their creators and marketers not only know it but make them that way on purpose.

According to the FDA, a medical device, subject to premarketing and postmarketing regulatory controls by the FDA, is defined in Section 201(h) of the Food, Drug, and Cosmetic Act as (emphasis mine in what follows):

  • “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

That strikes me as a pretty broad remit.

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

Paolo Macchiarini, Fraud, and Oversight: A Case of Falsified Stem Cell Research

by Michael S Dauber, GBI Visiting Scholar

According to a recent story by John Rasko and Carl Power in The Guardian, surgeon Paolo Macchiarini’s research in artificial windpipes, previously hailed as pioneering medicine with the promise to save many lives, has been exposed as a fraud. Miacchiarini had previously received public praise for creating artificial windpipes by grafting stem cells onto plastic frames, which allowed him to “grow” new trachea for his patients.

While much of the scientific community was eager to believe Miaccharini had made significant breakthroughs, not everyone was convinced. According to a Swedish TV series called Experimenten, most of Miaccharini’s patients died within a few years of their procedures, and it was unclear that the experimental surgeries actually helped: in fact, they may have made matters much worse. Deeper investigation revealed that Macchiarini had actually falsified much of his data, and that institutional checks that normally prevent fraudulent individuals from being hired had been ignored. For example, according to an “external inquiry,” he was hired by the Karolinska Institute in 2010 despite various fraudulent, concerning, and questionable information on his resume (including a claim from a reference that he had been “blocked from a professorship in Italy”). The report also found that there had been inappropriate contact between Macchiarini and the Karolinska Institute’s Vice-Chancellor during his recruitment.

Even more troubling, the Institute failed to comply with government regulations designed to ensure research and clinical interventions are practiced ethically. According to Rasko and Power, Macchiarini failed to test his artificial airways in animals before implanting them in three human patients, and he did not apply for approval from an institutional review board or other ethics committee, despite the fact that Stockholm’s board was housed at the Institute.

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

Web Roundup: Opioids as a National Emergency by Katherine Warren

After several years in the headlines, the U.S. opioid crisis has been in the news this summer as the federal government debates its status as a national emergency. On July 31st, the President’s Commission on Combating Drug Addiction and the Opioid Crisis, led by New Jersey Governor Chris Christie, released its interim report on the state of the U.S. opioid crisis. As their “first and most urgent recommendation” for President Trump, the members of the Commission urged him to “[d]eclare a national emergency under either the Public Health Service Act or the Stafford Act.”

The report emerged just as federal officials published a widely cited study showing that 91.8 million (37.8%) U.S. adults had used prescription opioids in 2015, 11.5 million (4.7%) had misused them, and 1.9 million (0.8%) had an opioid use disorder. Nearly half (40.8%) of the individuals who had misused opioids had obtained them for free from family or friends. News reports on the study also declared that “[o]pioid abuse started as a rural epidemic” of “hillbilly heroin” but has now become a “national one.”

President Trump did not initially declare a national opioid emergency, vowing instead in a briefing on August 8th to focus on prevention, increased law enforcement and drug-related prosecutions, and more aggressive policing of U.S. borders. By August 10th, after significant criticism, Trump told reporters, “We’re going to draw it up and we’re going to make it a national emergency.” As of September 1st, the Trump administration had yet to take the legal steps to formally declare a national emergency around the opioid crisis.

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

How paranoid should I be about my personal health care data privacy?

A recent Wall Street Journal article by Twila Brase suggests that anonymous medical data may not be so anonymous. This piqued my paranoia antenna. Her concern focuses on the new 21st Century Cures Act, which not only significantly increased funding for cancer research and opioid treatment programs, but also created “an ‘information commons’: a government-regulated pool of data accessible to all health researchers, regardless of… // Read More »

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

Offshore Herpes Vaccine Trial Under Investigation

September 1, 2017

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The government of St. Kitts and Nevis has launched an investigation into the clinical trial for a herpes vaccine by an American company because it said its officials were not notified about the experiments.

The vaccine research has sparked controversy because the lead investigator, a professor with Southern Illinois University, and the U.S. company he co-founded did not rely on traditional U.S. safety oversight while testing the vaccine last year on mostly American participants on the Caribbean island of St. Kitts.

The trial received financial backing from a former Hollywood filmmaker who has asserted the vaccine was highly successful in stopping herpes outbreaks. Since then, a group of investors, including Donald Trump supporter Peter Thiel, have backed the ongoing vaccine research with a $7 million investment that could include additional clinical trials in Mexico and Australia.

Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing on the 20 human subjects. Now, the government of St. Kitts and Nevis says that the researchers also did not officially seek permission to test the vaccine, which took place from April to August 2016.

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Scientific American

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

Webinar Follow-up: Data and Safety Monitoring: Advanced Issues and Case Studies

In July, PRIM&R collaborated with CITI Program to host the advanced-level webinar Data and Safety Monitoring: Advanced Issues and Case Studies. Expanding on introductory knowledge in the module Data and Safety Monitoring in Human Subjects Research, part of CITI Program’s Biomedical Basic course, this webinar described ways in which the IRB, the data and safety monitoring board (DSMB), the investigator, and the sponsor can work together to ensure scientific integrity and subject safety in clinical trials. Summaries of government and non-government organizations’ guidance as well as interactive case studies offered strategies for handling complex situations that may arise during data and safety monitoring, including when and how to report adverse and unanticipated events, when a DSMB is needed, and what is considered a conflict of interest.

The post Webinar Follow-up: Data and Safety Monitoring: Advanced Issues and Case Studies appeared first on Ampersand.

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

Taking Patient Autonomy Out of the DNR

by Craig Klugman, Ph.D.

The Texas government has passed SB 11 an act “relating to general procedures and requirements for certain do-not-resuscitate orders; creating a criminal offense.” As of April 1, 2018, one can be jailed for offenses involving DNR orders.  When new laws are passed they often require new regulations to interpret them as well as statements from the state attorney general on how they are to be enforced and viewed. While those steps have not yet been taken, the threat to physician practice and patient autonomy in this law necessitates taking a further look at it now.…

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.