Tag: risks and benefits

Bioethics Blogs

Human genome editing report strikes the right balance between risks and benefits

Gene therapy is growing in its capabilities, but there should be limits to its use. Shutterstock

If you recognise the words “CRISPR-mediated gene editing”, then you’ll know that our ability to alter DNA has recently become much more efficient, faster and cheaper.

This has inevitably led to serious discussions about gene therapy, which is the direct modification of someone’s DNA to rectify a genetic disorder, such as sickle cell anaemia or haemophilia. And you may also have heard of deliberate genetic enhancement, to realise a healthy person’s dreams of improving their genome.

Both of these issues have now been tackled in a comprehensive report on gene editing released today by the US National Academy of Science and National Academy of Medicine.

The message is fairly simple: relax, we’ve seen this all before, little if any harm has eventuated, and society is well placed to move forward together on this.

A definite maybe

Of all human technologies, recombinant DNA has arguably been one of the safest. There have been multiple benefits in both medicine and agriculture. And the legitimate concerns that arose when viruses were first mixed with bacterial genes, when cloning was first introduced, and when stem cells were developed, have not come to pass.

I cannot list all the benefits here, but if you have received the Hepatitis B vaccine or Australian Ian Fraser’s Gardasil vaccine, which protects against cervical cancer viruses, you have been protected from disease thanks to recombinant DNA technology.

However, you probably haven’t received somatic gene therapy, which is gene alteration directed at fixing one cell type, such as defective blood or liver cells.

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

HIV Cure Research and The Dual Aims of the Informed Consent Process

Guest Post: Danielle Bromwich and Joseph Millum

Paper: Informed Consent to HIV Research 

Special Issue: The benefit/risk ratio challenge in clinical research, and the case of HIV cure

A cure for HIV would be tremendously valuable. Approximately 37 million people worldwide are HIV-positive and 15 million are currently on antiretroviral therapy. Until recently it was assumed that this therapy would be the extent of HIV treatment and that those with access to it would need to take their drugs for life. But what once seemed impossible is now in early phase clinical trials: interventions designed to completely eradicate HIV from the immune system.

Excitement surrounding these “HIV cure” studies is tempered by ethical concern. They require participants to come off their antiretroviral therapy and undergo highly risky interventions using gene transfers or stem cell therapy. These are currently proof of concept studies—no one expects the participants to be cured. Their purpose is to provide essential information about safety and pharmacokinetics, but in doing so they expose participants to high risks with little prospect of direct benefit.

If we could be confident that participants understood their trials’ true risk-benefit ratio, these high risks might be less troubling. But such confidence would be misplaced. Decades of data show poor comprehension of risk among participants in clinical trials. The fact that HIV is still a stigmatized condition amplifies this concern. Potential participants may be desperate to be rid of their disease and so downplay the risks and exaggerate the potential benefits. Understandably, HIV cure researchers and research ethics committees are worried.

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

Crossing the Line: When Doctors’ Beliefs Endanger Patients’ Autonomy and Health

by Craig M. Klugman, Ph.D.

In 2016 the Illinois legislature passed and Governor Bruce Rauner signed into law Public Act 099-690 (SB 1564), an amendment to the Health Care Right of Conscience Act. This change states “It is also the public policy of the State of Illinois to ensure that patients receive timely access to information and medically appropriate care.” The change requires physicians to inform patients about legal treatment options including their factual risks and benefits, but does not require the physician to perform such services. If the hospital or physician has a conscientious objection to performing a procedure, then the patient must be referred to or transferred to someone or some facility that will.

For this effort, state officers have been sued in both state and federal courts by the Alliance Defending Freedom on behalf of a group of “pregnancy centers,” a doctor and her medical practice in Rockford, IL. Their complaint is that this law “forces them to promote abortion regardless of their ethical of moral views.” In other words, because the law requires doctors to allow patients to know all of their legal options indicated under standard of care and to be transferred elsewhere for services a physician or facility will not perform, this violates their religious freedom. The plaintiffs want it to be legal to lie, obfuscate, and keep information from patients and to keep patients away from legal and safe, medically indicated procedures. Specifically, this suit cites abortion.

Most surprisingly, a judge in a rural county has issued an injunction against the law going into effect (only) for the named plaintiffs.

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

Looking Back at the Bioethics Commission’s Blog

Throughout its tenure, the Bioethics Commission has maintained an active digital presence to connect with a global audience. A major component of this has been through its blog. This final blog post reflects on the role the blog has played in disseminating the Bioethics Commission’s work.

Former Bioethics Commission Executive Director Valerie Bonham launched the commission’s blog on November 15, 2010, announcing that the staff would be liveblogging during Meeting Three in Atlanta. From that meeting onward, Bioethics Commission staff continued to blog live from the Bioethics Commission’s meetings, held throughout the country in cities including Washington DC, Philadelphia, Salt Lake City, San Francisco, Chicago, and Boston. Meeting posts highlighted salient points of discussion as they occurred during the public meetings. For example, during Meeting Three, a blog post outlined the members’ deliberations regarding the risks and benefits of synthetic biology. During Meeting Eighteen, which focused on ethical issues in neuroscience, a blog post highlighted some of the discussion about the ethical challenges in neuroscience research. The Bioethics Commission also used blog posts to distill complex topics that arose during meetings. During Meeting Twelve, which focused on pediatric medical countermeasure research, a blog post presented a simplified structure of some of the federal regulations concerning pediatric research.

The commission’s blog also highlighted and explained the impact of the commission’s work. For example, during the commission’s tenure, a notice of proposed rulemaking (NPRM) to revise the Common Rule—the regulations that govern the ethical conduct of federally supported human subjects research—was published in the Federal Register on September 8, 2015.

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

Overcoming The Challenges In Advance Care Planning For Dementia Patients

Many newly diagnosed dementia patients
may have capacity and be fully able to state their preferences about future
medical care when they lose capacity. Their decisions about risks and benefits
of medical treatments while they have capacity flow from their critical interests which are the kinds of interests, which if not
satisfied, would make them think they were worse off in some way or that their
life had not be worthwhile. When a patient is capable of articulating his or
her critical interests we know what is most important about them in terms of
making their lives meaningful. So it would seem that preferences that stem from
critical interests about future medical care provides the most definitive
evidence possible, i.e. substituted judgment, for both medical and family caregivers to have as a basis on
which to be reasonably sure they are making decisions that the incapacitated
patient herself would make if she were in this same situation.

However, many incapacitated dementia
patients who by definition are no longer able to express their critical
interests are indeed still able to express preferences based in their experiential interestsExperiential interests are abiding
biologically based, immediate interests grounded in the quality of one’s life
from activities in which they are finding satisfaction, pleasure, and amusementThe
situation becomes particularly challenging when it appears that the
incapacitated dementia patient is expressing a preference based on experiential
interests that runs contrary to a prior expressed preference stemming from
critical interests.

Because patients with severe dementia
experience their lives in discrete moments, each expressing its own set of
experiential interests, there is also a concern about how to understand the
changing self of the patient and interpret her wishes and preferences
throughout the transitions, particularly at the end of life.

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

Public health campaigns in healthcare: mothers should breastfeed!

Public health campaigns do to some extent infringe upon our lives. Maybe we are prepared to allow some of these intrusions. We protest a little, just for show, but still adopt the message and begin to think that we probably ought to eat a little more X and a little less Y.

Some campaigns, however, encroach on sensitive areas of life, in more vulnerable situations, and in places where one would expect more personal respect.

Campaigns to encourage mothers to breastfeed, instead of giving infant formula, provide an example. These campaigns occur not least in healthcare, in contacts with new mothers who for various reasons may have difficulties with breastfeeding, or who don’t want to breastfeed.

Earlier this year, Jessica Nihlén Fahlquist had an article published in Nursing Ethics about such mothers’ experiences. It’s about mothers who don’t breastfeed and about their experiences of contacts with healthcare and being met with campaigning.

The survey responses described in the article suggest that these mothers can feel like bad mothers. They are told that breastfeeding is the best and safest option for the child, that all mothers can breastfeed if they just try, and that “artificial” formula feeding increases the risk of malnutrition and various diseases in the child.

The mothers feel that they don’t get opportunity to talk about their problems or desires to find a way of feeding their child that works for them. Might not bottle feeding be the better option for some mothers and children? The information seems, to a great extent, to be about communicating the norm that a real mother should breastfeed.

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

Strengthening ‘Ethics’ in Health Systems Research

By Bridget Pratt, Coordinator for the HSG Ethics of Health Systems Research TWG, and Joseph Ali

 

Crossposted from hsg: health systems global blog

 

Funders, researchers, institutions, and research ethics committees (RECs) worldwide are struggling to interpret and apply ethical principles to the increasing number of health systems research (HSR) studies being performed globally. Available research ethics guidelines, while relevant to HSR, focus predominantly on traditional forms of health research, including biomedical, social science, and epidemiological research.

 

But currently, no comprehensive HSR-specific guidelines exist that lay out the relevant ethical issues to consider when conducting HSR projects and provide guidance on how to address them. That HSR-specific guidelines are needed has been recognised by bioethicists and bodies such as the Alliance for Health Policy and Systems Research. Without such guidelines, key ethical issues in HSR studies are likely to be overlooked and (as a result) not addressed, or addressed inappropriately.

 

A first step to develop HSR-specific ethics guidance

 

We were recently part of a team funded by the Alliance for Health Policy and Systems Research to perform a scoping review of the HSR ethics literature. We set out to identify a number of factors: the key ethics issues that arise when conducting HSR, with a focus (though not exclusive) on low- and middle-income (LMIC) settings; existing guidance on these ethical issues; and any gaps in the available guidance.

 

What emerged from the review were a number of ethical issues and a limited amount of guidance within various categories: 1) justice, 2) identifying and balancing risks and benefits, and 3) upholding autonomy.

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

Our Special Treatment of Patients in a Vegetative State is a Form of Cruel and Unusual Punishment

by Professor Dominic Wilkinson, @Neonatalethics
Professor of Medical Ethics, Consultant Neonatologist

Our society has good reason to provide special treatment to people with severe brain injuries and their families.

But our current “special treatment” for a group of the most severely affected people with brain injuries leads to devastating, agonising, protracted and totally preventable suffering.

Consider the following cases:

Case 1. Sally has severe progressive dementia. She is no longer able to communicate, and does not recognize any of her family members. Sally had previously spoken with her family and told them that if she were ever in such a state and not likely to improve, that she would not want to be kept alive artificially. Sally’s doctor has been called to her nursing home because she has pneumonia. Although the infection could be treated with antibiotics, the doctor and family together decide not to. Sally dies a few days later.

Case 2. Sandra has suffered a severe head and spinal injury in a car accident. She has been in intensive care for several weeks, but there is no sign of improvement. Her brain scans show extensive damage, and it is likely that if she survives Sandra would be severely disabled. Sandra had previously spoken with her family and told them that if he were ever in such a state and not likely to improve, that she would not want to be kept alive artificially. Although Sandra could be kept alive for some time if treatment continues, the doctors and the family together decide to stop life support.

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

Helping Patients Make the Right Decisions

Dhruv Khullar, “Despite tremendous advances in health care, most medicine still occurs in a gray zone: There aren’t right or wrong answers, but rather a continuum of risks and benefits”

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

“Ethically Sound” Episode 1: Safeguarding Children

Since the Bioethics Commission was established via Executive Order by President Obama, the Bioethics Commission has released 10 reports on a variety of ethically challenging topics, and has provided recommendations on topics ranging from synthetic biology to neuroscience to whole genome sequencing. In an effort to share the Bioethics Commission’s work with a wide variety of audiences, we are issuing a new podcast series called “Ethically Sound.” Today’s episode, the first in the series, focuses on the Commission’s report Safeguarding Children: Pediatric Medical Countermeasure Research, which addressed the ethically challenging topic of when and how to test pediatric medical countermeasures for possible bioterrorism agents. When and how, for example, should we test an anthrax vaccine, approved for adults, in children?

The Ethically Sound: Safeguarding Children podcast centers around the question: How can we best protect children in the event of a bioterrorism attack? At the time this report was written, a vaccine for anthrax had only been tested in adults, but not in children. The Commission was asked to provide recommendations on how this vaccine could be safely tested in children, and when the vaccine would be ethically permissible to test.

The podcast opens with a narrative from Dr. Suzet McKinney, who is the Executive Director of the Illinois Medical District Commission. Dr. McKinney discusses how her public health training taught her that vaccines were largely beneficial, but the thought of an anthrax vaccine that had not been tested in children was a cause for concern. “If there were an anthrax bioterrorism attack in the US and the government determined a need to immunize children with a vaccine that had not been tested and deemed safe, experience tells me that even the most aggressive and comprehensive efforts to educate parents about the risks and potential benefits will be met with anxiety, fear, protest and apprehension… even I would have difficulty agreeing to an untested anthrax vaccine for my own child in the absence of a real, credible threat of attack.”

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.