Tag: ebola

Bioethics Blogs

Breakthrough Immunotherapies Seem Like a Dream Come True for Children with Leukemia

Guest Post: Nancy Jecker, Aaron Wightman, Abby Rosenberg, Doug Diekema

Paper: From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies

A breakthrough therapy to cure cancer in children suffering from acute lymphoblastic leukemia (ALL) is a dream for many families.  New immunotherapies appear to make this dream a reality. Such therapies use a person’s own immune cells to recognize and combat their disease. In the largest study to date of ALL patients treated with a form of immunotherapy known as Chimeric Antigen Receptor (CAR) T-Cell therapy, a 93% remission rate was reported. Such results are a glimmer of hope for those whose prognoses were previously considered very poor.

However, the good news is tempered by the fact this potentially lifesaving experimental therapy may not be available to everyone who might benefit. And demand is growing as word spreads. Since CAR T-cell therapy for ALL is available only through clinical trials, do patients have a right to participate? How should we choose among medically suitable candidates?

We have faced these questions before. Most recently, with ZMapp to treat Ebola Virus Disease, azidothymidine (AZT) to treat HIV and AIDS, and Immunitab (Gleevac) to treat Chronic Myleogenous Leukemia. Are patients suffering from devastating, life-threatening diseases entitled to breakthrough therapies?

In a recent paper, we argue that benefit is a continuum, from the complete uncertainty associated with standard research, to an intermediate stage where evidence of benefit mounts and reaches a peak, to a final stage of clearly demonstrated benefit that is sufficient to gain approval for clinical applications.

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

Individually-randomized controlled trials of vaccines against the next outbreak

Guest Post: Nir Eyal, Marc Lipsitch

Paper: Vaccine testing for emerging infections: the case for individual randomisation 

The humbling experience of international response to Ebola taught the world a thing or two on preparing for Zika and for other emerging infections.

Some of those lessons pertain to vaccine development against emerging infections. One lesson was that vigorous vaccine development should start long in advance of outbreaks. CEPI, the Coalition for Epidemic Preparedness Innovations, was recently launched with an initial investment of half a billion US dollars from the Gates Foundation, Britain’s Wellcome Trust and the governments of Japan, Norway and Germany. There is also growing recognition that best practices on vaccine testing should be developed prior to outbreaks, from a study methodology viewpoint.

By contrast, in Zika, ethical guidelines on response in general and on an aspect of vaccine testing were created only once the pandemic erupted. Shouldn’t ethical disputes, e.g. on trial design for vaccine candidates, be ironed out in advance of emerging infections?

One persistent ethical question in vaccine testing pertains to individually-randomized control in efficacy trials. At the height of the 2014-5 Ebola outbreak, individually-randomized controlled trials were much maligned. Our paper at the Journal of Medical Ethics sets out to defend that approach for vaccine efficacy testing in emerging infections, including highly fatal and untreatable ones in developing countries.

Nearly everyone agrees that scientifically, individually-randomized controlled trials are the gold standard of clinical research. But during the Ebola outbreak, ethicists, leaders, and humanitarian workers opposed them. For testing vaccine against a highly fatal infection without approved drugs or vaccines, they deemed these designs unethical.

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

The First Cut is the Deepest

March 23, 2017

by Sean Philpott-Jones, Chair, Bioethics Program of Clarkson University & Icahn School of Medicine at Mount Sinai

The First Cut is the Deepest

Last week, President Trump publicly unveiled his 2018 budget proposal. If left unchanged, that financial blueprint would increase US federal defense spending by more than $50 billion, while also appropriating billions more to bolster immigration enforcement and build a 2,000 mile-long wall along the US border with Mexico. A self-proclaimed deficit hawk, the President would offset those increased expenditures will sharp cuts to the US Departments of State, Energy, Health and Human Services, and the US Environmental Protection Agency.

In sharp contrast to campaign trail promises to boost the economy, create jobs, and protect Americans at home and abroad, however, Trump’s 2018 budget is likely to do the exact opposite. Consider, for example, the proposal to cut nearly $6 billion from the US National Institutes of Health (NIH).

Made up of 27 different institutions and centers, the NIH is the largest supporter of biomedical research in the world. Through the NIH or other funding agencies, the federal government supports almost half of all the biomedical research in the US. Private businesses support another quarter, and the remainder of biomedical research support comes from state governments and nonprofit organizations.

With an annual operating budget of $30 billion, the NIH provides training and support to thousands of scientists at its main campus in Bethesda, Maryland. Moreover, through a system of extramural grants and cooperative agreements, the NIH provides financial support for research-related programs to over 2,600 institutions around the country, creating more than 300,000 full- and part-time jobs.

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

Drop the Kleenex and Put Your Hands Up

February 09, 2017

by Sean Philpott-Jones, Chair, Bioethics Program of Clarkson University & Icahn School of Medicine at Mount Sinai

Drop the Kleenex and Put Your Hands Up

For the past week, mainstream, alternative, and social media outlets here in the United States and abroad have been consumed with discussion and debate about the legality and morality of President Trump’s recent travel ban. However, the so-called Muslim travel ban is not the only set of potentially controversial restrictions put into place recently.

Unbeknownst to most, the federal government is also planning to expand greatly the power of the US Centers for Disease Control and Prevention (CDC) to detain people who are suspected of carrying a dangerous communicable illness. Also known as quarantine – a term that comes from the Italian word for forty, in honor of the practice in Early Renaissance Venice to make trading vessels remain anchored offshore for 40 days before entering the port – the detention, isolation and even forcible treatment of those potentially exposed to a infectious disease like tuberculosis or Ebola is one of the most powerful and one of the most contentious tools in the public health arsenal.

The authority of local, state, and federal officials to do this comes from the parens patriae powers of the state. Latin for “parent of the nation, parens patriae refers to the legal doctrine that the government has a responsibility to protect those who cannot care for themselves. This includes, for example, the power of the state to intervene against an abusive or negligent parent.

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

Ebola Vaccines Provide Immune Responses after One Year

March 14, 2017

(Medical Xpress) – Immune responses to Ebola vaccines at one year after vaccination are examined in a new study appearing in the March 14 issue of JAMA. The Ebola virus vaccine strategies evaluated by the World Health Organization in response to the 2014-2016 outbreak in West Africa included a heterologous primary and booster vaccination schedule of the adenovirus type 26 vector vaccine encoding Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia virus Ankara vector vaccine, encoding glycoproteins from Ebola, Sudan, Marburg, and Tai Forest viruses nucleoprotein (MVA-BN-Filo).

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

Drop the Kleenex and Put Your Hands Up February 9, 2017 Unbeknownst to most, the federal gov…

February 09, 2017

by Sean Philpott-Jones, Chair, Bioethics Program of Clarkson University & Icahn School of Medicine at Mount Sinai

Drop the Kleenex and Put Your Hands Up

For the past week, mainstream, alternative, and social media outlets here in the United States and abroad have been consumed with discussion and debate about the legality and morality of President Trump’s recent travel ban. However, the so-called Muslim travel ban is not the only set of potentially controversial restrictions put into place recently.

Unbeknownst to most, the federal government is also planning to expand greatly the power of the US Centers for Disease Control and Prevention (CDC) to detain people who are suspected of carrying a dangerous communicable illness. Also known as quarantine – a term that comes from the Italian word for forty, in honor of the practice in Early Renaissance Venice to make trading vessels remain anchored offshore for 40 days before entering the port – the detention, isolation and even forcible treatment of those potentially exposed to a infectious disease like tuberculosis or Ebola is one of the most powerful and one of the most contentious tools in the public health arsenal.

The authority of local, state, and federal officials to do this comes from the parens patriae powers of the state. Latin for “parent of the nation, parens patriae refers to the legal doctrine that the government has a responsibility to protect those who cannot care for themselves. This includes, for example, the power of the state to intervene against an abusive or negligent parent.

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

The Trials of Patient O

By: Jennifer Cohen

In 1987, Harry Reasoner of 60 Minutes questioned Dr. Selma Dritz about her search in the early 1980s for the origins of the deadly outbreak of AIDS in the United States. “It was the whodunit of the century, and I was born nosy,” she tells him. The title of the 60 Minutes piece was “Patient Zero” who Mr. Reasoner explains “was a man – a central victim and victimizer” in the spread of AIDS.  Dr. Dritz, who had been the head of infectious diseases in the San Francisco branch of the Centers for Disease Control and Prevention (CDC), recalled warning Patient Zero of the danger he posed to others. In her retelling, Mr. Dugas callously rebuffed her concerns, showed little remorse for infecting others, and concluded their interaction with “screw you.” Also interviewed was Randy Shilts whose book, And the Band Played On, identified Patient Zero as Gaëtan Dugas, a Canadian flight attendant. Mr. Shilts explained that Mr. Dugas constituted what epidemiologists today call a superspreader – someone with unlimited ability to infect others and “speed this disease into every corner of America.”  The narrative of a villainous foreigner maliciously spreading a deadly epidemic culminated in an infamous New York Post headline condemning Mr. Dugas as “THE MAN WHO GAVE US AIDS.”

The story unraveled upon closer inspection.  In 1984, the CDC had indeed identified a “Patient O” who had sexual connections with other AIDS patients, but the “O” stood for “Outside” California. Nowhere in the study is “Patient O” identified as “Patient Zero” — i.e., the person who introduced the virus in America.

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

Ebola Nurse Salome Karwah Died after Hospital Neglect, Husband Says

March 1, 2017

(BBC) – Liberian nurse Salome Karwah was one of those named as Time magazine’s person of the year in 2014 for her frontline work against Ebola. She died in Monrovia last week after giving birth to a son. Her husband told the BBC that nurses were unwilling to touch her for fear of contracting Ebola – even though she recently tested negative for Ebola. The hospital has not commented, and officials say they are investigating the death.

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

Disease ‘Superspreaders’ Accounted for Nearly Two-Thirds of Ebola Cases, Study Finds

February 23, 2017

(The Washington Post) – They are called superspreaders, the minority of people who are responsible for infecting many others during epidemics of infectious diseases. Perhaps the most famous superspreader was Typhoid Mary, presumed to have infected 51 people, three of whom died, between 1900 and 1907. Now scientists studying how Ebola spread during the 2014-2015 epidemic in West Africa say superspreaders played a bigger role than was previously known, according to findings published this week in the Proceedings of the National Academy of Sciences.

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

Zika Timeline of Events

Zika Timeline of Events

February 14, 2017

Even though the Zika virus did not make national headlines until November 2015 when Brazil declared a national emergency after reporting an abnormally high number of cases of babies born with microcephaly or Guillain-Barré syndrome, the virus was actually first identified in 1947 in a rhesus monkey in the Zika forest of Uganda. Zika is a mosquito-borne disease that shows mild-to-moderate symptoms in adult humans. Its symptoms are similar to dengue fever and chikungunya. The first human case of Zika was found in Uganda and The United Republic of Tanzania in 1952.

In the intervening sixty years, some cases of Zika were found throughout western Africa and Asia. However, these populations seemed to have a fairly good immunity to the disease. It was not until the virus hit the Pacific Islands in 2007 that it became an outbreak. In 2013, a Zika outbreak occurred in several more Pacific Island nations, and it was during this time that Zika was suspected of causing neurological and autoimmune problems.

By March 2015, Brazil reported an illness that expressed a skin rash, and by May, Brazil confirmed that Zika was in the country. In July, they found that certain neurological disorders correlated with Zika infection, but this was isolated to the state of Bahia. Then, in October, Brazil reported an inordinate number of cases of microcephaly among newborns, and declared a national emergency in November. Meanwhile, cases of Zika were increasingly reported throughout northern South America and Central America. By January 2016, researchers had drawn preliminary links to pregnant mothers infected by Zika and babies born with microcephaly.

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.