Tag: biomarkers

Bioethics Blogs

Personalized Medicine: Our Future or Big Data Voodoo?

Kumar Ethirajan, MD

NOTE: Kumar Ethirajan, MD, an oncologist specializing in cancer genetics in the Kansas City area since 1993 and member of the Center for Practical Bioethics’ board of directors, will present this topic as part of the Center’s BIOETHICS MATTERS lecture series on Wednesday, July 19, 7:00 pm, at the Kansas City Public Library Plaza Branch, 4801 Main Street, Kansas City, MO. Bring your perspectives, questions and personal stories. Admission is free. All are welcome. 

Personalized medicine has the potential to revolutionize medicine. Actually, that’s not true. Personalized medicine IS REVOLUTIONIZING medicine. 

Personalized medicine IS our future! Yet, based on a 2013 survey by GfK, a global consumer research firm, just 27% of people have heard of the term personalized medicine and, of those, only 4% understand what the term means.

You may have heard personalized medicine referred to as genomic medicine, precision medicine or individualized medicine. Whatever you call it, it’s medicine that uses information about your genes to prevent, diagnose and treat disease. In cancer, it’s about using information about a tumor to discover certain biomarkers or genes and, hopefully, having a drug to treat it. So far, researchers have discovered more than 1800 disease genes, created more than 2,000 genetic tests for human conditions, and have 350 drugs currently in clinical trials.

So, this is great, right? Yes. But consider that some 30% of the world’s stored data is generated by the healthcare industry – and that a single patient on average generates 80 megabytes per year! With healthcare data exploding like this, shouldn’t we be thinking about the questions it raises?

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

Startup That Charges $8,000 for Young Blood Transfusions Swears They’re Worth Every Penny

June 1, 2017

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A month after receiving a transfusion of young plasma, Karmazin says, participants had fewer chemical biomarkers indicative of heart disease, Alzheimer’s, and certain types of cancers.

The results are extremely preliminary; they not published in a peer-reviewed, and there was no control study. Ambrosia got the US Food and Drug Administration’s approval to begin conducting a controversial clinical trial in May 2016, and participants essentially pay for the unproven treatment out of pocket. For $8,000, healthy individuals over 35 can have a transfusion of plasma from someone aged 16 to 25 as part of an ongoing clinical trial.

In the Ambrosia trial, roughly 80 participants with a median age of 60 had their blood tested for around 100 different biomarkers before receiving a single transfusion, and then again a month later. On average, patients had 21% fewer carcinoembryonic antigens, a compound associated with lung, colon, and ovarian cancer; 10% fewer apolipoproteins, associated with heart disease; and 20% fewer amyloid plaques, associated with Alzheimer’s. Speaking to Quartz, Karmazin said patient reported feeling like they had more energy.

It should be noted, though, that these biomarkers do not indicate disease itself; none of the participants who enrolled in the trial were seriously ill before receiving the transfusion.

… Read More

Image: By DiverDave – Own work, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=11866692

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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 you’ll grow up, and how you’ll grow old

By Nathan Ahlgrim
Nathan Ahlgrim is a third year Ph.D. candidate in the Neuroscience Program at Emory. In his research, he studies how different brain regions interact to make certain memories stronger than others. In his own life, he strengthens his own brain power by hiking through the north Georgia mountains and reading highly technical science…fiction.

An ounce of prevention can only be worth a pound of cure if you know what to prevent in the first place. The solution to modifying disease onset can be fairly straightforward if the prevention techniques are rooted in lifestyle, such as maintaining a healthy diet and weight to prevent hypertension and type-II diabetes. However, disorders of the brain are more complicated – both to treat and to predict. The emerging science of preclinical detection of brain disorders was on display at Emory University during the April 28th symposium entitled, “The Use of Preclinical Biomarkers for Brain Diseases: A Neuroethical Dilemma.” Perspectives from ethicists, researchers conducting preclinical research, and participants or family members of those involved in clinical research were brought together over the course of the symposium. The diversity of panelists provided a holistic view of where preclinical research stands, and what must be considered as the field progresses.
Throughout the day, panelists discussed different ethical challenges of preclinical detection in the lens of three diseases: preclinical research and communicating risk in the context of Autism Spectrum Disorder (ASD), interventions and treatment of preclinical patients in the context of schizophrenia, and the delivery of a preclinical diagnosis and stigma in the context of Alzheimer’s disease.

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 Very Early Embryo & Its Moral Signifiance

by Andrew J. Prunty

As technology and biological research continue to develop in the twenty-first century, it is necessary to address and further define the ethical considerations of embryonic research and the appropriate rights that may limit the extent of human research on zygotes, blastocysts, and fetal scientific advancement. Because the area of harvesting embryonic stem cells remains significantly undefined, both legally and morally, there are vastly different opinions between researchers and bioethicists, mainly because of ethical limitations, on the rights that should be granted to cells with the potential to develop into human beings and the consequences of neglecting significant scientific research or advancement.

Current laws in the United States differ at the federal and state level, but there is no consistency in recognizing human embryos as humans, or affording them the same legal rights granted to a child; in fact, legal precedent actually detracts certain rights from developing embryos, favoring a human’s ability to destroy a potential human being (i.e. Roe v. Wade[i]) or the categorization of embryos as property (i.e. Davis v. Davis[ii], A.Z. v. B.Z.[iii], Marriage of Dahl[iv], or Reber v. Reiss[v]). These case law samples suggest the courts’ inability to reach a conclusion as to what is the status of an embryo.

The debate is not only circumscribed to matters of research, but to fundamental controversial and intertwined issues of bioethics such as: when life begins, embryonic stem cells, fetal rights, abortion, et cetera. All these topics are contentious and when one topic arises, they begin to comingle.

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

Antibody Makes Alzheimer’s Protein Detectable in Blood

Caption: The protein tau (green) aggregates abnormally in a brain cell (blue). Tau spills out of the cell and enters the bloodstream (red). Research shows that antibodies (blue) can capture tau in the blood that reflect its levels in the  brain.
Credit: Sara Moser

Age can bring moments of forgetfulness. It can also bring concern that the forgetfulness might be a sign of early Alzheimer’s disease. For those who decide to have it checked out, doctors are likely to administer brief memory exams to assess the situation, and medical tests to search for causes of memory loss. Brain imaging and spinal taps can also help to look for signs of the disease. But an absolutely definitive diagnosis of Alzheimer’s disease is only possible today by examining a person’s brain postmortem. A need exists for a simple, less-invasive test to diagnose Alzheimer’s disease and similar neurodegenerative conditions in living people, perhaps even before memory loss becomes obvious.

One answer may lie in a protein called tau, which accumulates in abnormal tangles in the brains of people with Alzheimer’s disease and other “tauopathy” disorders. In recent years, researchers have been busy designing an antibody to target tau in hopes that this immunotherapy approach might slow or even reverse Alzheimer’s devastating symptoms, with promising early results in mice [1, 2]. Now, an NIH-funded research team that developed one such antibody have found it might also open the door to a simple blood test [3].

Scientists know that tau loosened from abnormal tangles exits the brain and enters the bloodstream.

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

Join us for the Emory Graduate Student Neuroethics Symposium on April 28th, 2017

This spring, the Neuroscience Graduate Program and the Neuroethics Program at Emory University are teaming up to present the 2017 Emory Graduate Student Neuroethics Symposium entitled, The Use of Preclinical Biomarkers for Brain Diseases: A Neuroethical Dilemma. This year’s symposium will focus on the neuroethics of preclinical detection, including discussions of the basic and clinical research being performed and the neurotechnologies being developed for the early detection of autism, schizophrenia, and Alzheimer’s disease. 
The symposium will take place on Friday, April 28th from 10am to 4:30pm at Emory University and is free and open to the public. The symposium will be comprised of three sessions: 

Session 1: Autism, with a focus on the ethics of conducting preclinical research.
Session 2: Schizophrenia, with a focus on the ethics of interventions and treatment.
Session 3: Alzheimer’s disease, with a focus on the ethics of delivering a preclinical diagnosis given the risks for stigma. 

Each session will include input from a patient diagnosed with the disease or family member of someone experiencing the disease, a researcher/clinician, and an ethicist. Speakers will include Dr. Cheryl Klaiman, Dr. Donna Chen, Dr. Dena Davis, Dr. Paul Root Wolpe, Dr. Elaine Walker, and Dr. Allan Levey.
Through this symposium, we hope to highlight the challenges that a patient can face after being given a preclinical diagnosis for a mental disorder, and to underscore the ethical challenges that arise when the ability to detect a future disease outreaches our ability to care for the patient.
You can find more information on our website and in the flyer below, and can register for the event here.

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

Moving Toward Answers in ME/CFS

Thinkstock/Katarzyna Bialasiewicz

Imagine going to work or school every day, working out at the gym, spending time with family and friends—basically, living your life in a full and vigorous way. Then one day, you wake up, feeling sick. A bad cold maybe, or perhaps the flu. A few days pass, and you think it should be over—but it’s not, you still feel achy and exhausted. Now imagine that you never get better— plagued by unrelenting fatigue not relieved by sleep. Any exertion just makes you worse. You are forced to leave your job or school and are unable to participate in any of your favorite activities; some days you can’t even get out of bed. The worst part is that your doctors don’t know what is wrong and nothing seems to help.

Unfortunately, this is not fiction, but reality for at least a million Americans—who suffer from a condition that carries the unwieldy name of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), a perplexing disease that biomedical research desperately needs to unravel [1]. Very little is currently known about what causes ME/CFS or its biological basis [2]. Among the many possibilities that need to be explored are problems in cellular metabolism and changes in the immune system.

A number of studies suggest that abnormalities in cellular metabolism, a complex biological process that the body uses to create energy [3][4][5], may underlie ME/CFS. A recent study of metabolite pathways in blood samples from people with ME/CFS reported a signature suggestive of a hypometabolic condition, similar to a phenomenon biologists have studied in other organisms and refer to by the term “dauer” (a hibernation-like state) [5].

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

Predicting Psychosis: Exploring Pre-Clinical Signs for Mental Illness

By Sunidhi Ramesh

This post is based on the January edition of the “Neuroethics and Neuroscience in the News” series in which Dr. Elaine Walker from Emory University discussed the ethics of assessing risk and treating brain diseases before they can be diagnosed.
This self-portrait is often used to depict the distorted
reality that many schizophrenia patients face.
(Image courtesy of Wikimedia Commons.)

“This calculator,” a 2016 headline states, “can predict your risk of developing psychotic disorders.”

Psychotic disorders, including schizophrenia and bipolar disorder with psychotic features, are characterized by noticeable deficits in “normal” behavior accompanied by hallucinations, delusions, paranoia, an early onset (the average age of onset is in the late teens or early twenties), and a derailed life course.
Because of its early age at onset, the DALY (disability adjusted life years) value for psychosis is significantly greater than that of other illnesses (1). It’s no surprise, then, that researchers are asking questions. Are there measures that can be taken to keep at-risk populations from enduring a life-hindering disability?
Fifteen years ago, the answer would be no. Today, it (just might be) yes. 

How? Researchers have recently identified patterns in pre-clinical psychotic symptoms— patterns that many psychotic patients exhibit long before they are formally diagnosed with a disorder.
In schizophrenia and other psychotic disorders that “interfere with a person’s ability to think clearly, manage emotions, make decisions and relate to others,” this pre-clinical period is called the prodromal period. During this time, patients often experience gradual disruptions in behavioral functioning (like being suspended from school or losing friends) that are accompanied by subclinical or reduced psychotic symptoms (like hallucinations and delusions).

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

In the Journals – December 2016, Part II by Anna Zogas

Here is the second part of our article roundup for December (find the first set of articles here). Happy reading, and happy new year!

New Genetics and Society

Redrawing the boundary of medical expertise: medically assisted reproduction and the debate on Italian bioconstitutionalism
Volha Parfenchyk

In 2004, the Italian Parliament passed a controversial law on medically assisted reproduction (Law 40/2004). The Law obliged clinicians to create a maximum of three embryos during one in vitro fertilization (IVF) cycle and transfer them simultaneously into the patient’s uterus. With this “three embryo” standard, the Parliament sought to secure the realization of rights of IVF embryos. Drawing on the concepts of boundary-work and bioconstitutionalism, this article explores the role that the constitutional obligations of the Italian State towards its citizens, including IVF embryos as its new “citizen subjects,” played in how it envisaged and demarcated the professional boundaries of medical expertise. It argues that the latter depended upon how it balanced its commitments to protect the rights of IVF embryos and those of adult citizens. As such, the demarcation of the jurisdictional boundaries of medical expertise, and the definition of constitutional rights, formed two sides of the same governing project.

Traveling questions: uncertainty and nonknowledge as vehicles of translation in genetic research participation
Klaus Hoeyer

In this paper, I argue that uncertainty and nonknowledge, and not just research results, can be important vehicles of translation through which genetic research participation comes to affect the lives of research participants. Based on interviews with participants in a genetic research project, I outline epistemic, emotional, relational and moral implications of research participation.

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

Pedophilia: Prevention or Paternalism?

by Mike Reaves

“There is no cure, so the focus is on protecting children.”[i]

Harvard Medical Health Letter, July 2010

Pedophilia, or the sexual attraction to children who have yet to reach puberty, continues to perplex clinicians and researchers in the 21st century. There is often much confusion surrounding this term, as society commonly groups pedophiles alongside child molesters. However, not all persons with these sexual interests actually act on them. Many individuals who have these sexual preferences stay celibate their entire lives. While there may be no cure for pedophilia, there are new treatment options that may be available to the public in 2018.

Researchers at Karolinska Institute in Sweden are attempting to fund a full-scale scientific drug trial that may provide hope for those seeking treatment. Dr. Christoffer Ramm is the principal investigator of this research study; his background includes research on the neuropsychological aspects of psychosis. His team refers to their work with the acronym PRIOTAB, or “Pedophilia at Risk – Investigations of Treatment and Biomarkers,” a collective that seeks to make society safer – both for children and those who suffer from these complex disorders. In their study proposal, Priotab notes that in Sweden 10% of boys and 5% of girls are sexually assaulted; and individuals with pedophilic disorder commit 50% of these assaults.[ii] The Priotab team claims that they can repurpose the pharmaceutical drug Degarelix, which has typically been used to treat prostate cancer. The team believes an effective treatment will reduce the social stigma associated with seeking treatment for pedophilia and also protect those who cannot protect themselves.

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.