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Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy
Showing posts with label Experimental Treatments. Show all posts
Showing posts with label Experimental Treatments. Show all posts

Friday, October 18, 2019

The Koch-backed right-to-try law has been a bust, but still threatens our health

Michael Hiltzik
The Los Angeles Times
Originally posted September 17, 2019

The federal right-to-try law, signed by President Trump in May 2018 as a sop to right-wing interests, including the Koch brothers network, always was a cruel sham perpetrated on sufferers of intractably fatal diseases.

As we’ve reported, the law was promoted as a compassionate path to experimental treatments for those patients — but in fact was a cynical ploy aimed at emasculating the Food and Drug Administration in a way that would undermine public health and harm all patients.

Now that a year has passed since the law’s enactment, the assessments of how it has functioned are beginning to flow in. As NYU bioethicist Arthur Caplan observed to Ed Silverman’s Pharmalot blog, “the right to try remains a bust.”

His judgment is seconded by the veteran pseudoscience debunker David Gorski, who writes: “Right-to-try has been a spectacular failure thus far at getting terminally ill patients access to experimental drugs.”

That should come as no surprise, Gorski adds, because “right-to-try was never about helping terminally ill patients. ... It was always about ideology more than anything else. It was always about weakening the FDA’s ability to regulate drug approval.”

The info is here.

Wednesday, February 21, 2018

The Federal Right to Try Act of 2017—A Wrong Turn for Access to Investigational Drugs and the Path Forward

Alison Bateman-House and Christopher T. Robertson
JAMA Intern Med. Published online January 22, 2018.

In 2017, President Trump said that “one thing that’s always disturbed”1 him is that the US Food and Drug Administration (FDA) denies access to experimental drugs even “for a patient who’s terminal…[who] is not going to live more than four weeks [anyway.]”  Fueled by emotionally charged anecdotes recirculated by libertarian political activists, 38 states have passed Right to Try laws. In 2017, the US Senate approved a bill that would create a national law (Box). As of December 2017, the US House of Representatives was considering the bill.

The article is here.

Tuesday, January 16, 2018

3D Printed Biomimetic Blood Brain Barrier Eliminates Need for Animal Testing

Hannah Rose Mendoza
3Dprint.com
Originally published December 21, 2017

The blood-brain barrier (BBB) may sound like a rating system for avoiding horror movies, but in reality it is a semi-permeable membrane responsible for restricting and regulating the entry of neurotoxic compounds, diseases, and circulating blood into the brain. It exists as a defense mechanism to protect the brain from direct contact with damaging entities carried in the body. Normally, this is something that is important to maintain as a strong defense; however, there are times when medical treatments require the ability to trespass beyond this biological barrier without damaging it. This is especially true now in the era of nanomedicine, when therapeutic treatments have been developed to combat brain cancer, neurodegenerative diseases, and even the effects of trauma-based brain damage.

In order to advance medical research in these important areas, it has been important to operate in an environment that accurately represents the BBB. As such, researchers have turned to animal subjects, something which comes with significant ethical and moral questions.

The story is here.

Monday, December 25, 2017

First Baby Born To U.S. Uterus Transplant Patient Raises Ethics Questions

Greta Jochem
NPR.org
Originally published December 5, 2017

Here is an excerpt:

We mention that not everyone is celebrating this. It raises some ethical questions. Is it possible with a procedure that is so experimental, so risky, to get informed consent from women who desperately want to have a baby?

Dr. Testa: I doubt it is possible for lay people to have informed consent about anything we do in medicine, if you ask me. This is even more complicated because we are going into uncharted waters. ... I think that we go through years of studying to understand what we do, and to achieve mastering the things we do. And then we pretend that in ten minutes we can explain something to anybody. ... I don't think it's really possible.

... We try to use the simplest terms we can think about and then we leave it to the autonomy of the patients, in this case not even patients, these women, to make the decisions. I think we really refrain, and it was really important for us, from any pressure of any kind from our side but then of course, the inner pressure of this woman to have a child I think drove the entire process and their decision at the end.

The article is here.

Friday, September 30, 2016

An Ethical Argument for Regulated Cognitive Enhancement in Adults

by Selin Isguven
Voices in Bioethics

Human enhancement consists of methods to surpass natural and biological limitations, usually with the aid of technology. Treatment and enhancement are considered to be different in that treatment aims to cure an existing medical condition and restore the patient to a normal, healthy, or species-typical state whereas enhancement aims to improve individuals beyond such a state.  However, the line between treatment and enhancement remains debatable. There is no one agreed-upon definition of the normal human condition; this definition depends on factors such as time period and location, among many. In fact, the debate stems from discussions about the scope of medicine and the definition of ‘healthy.’  For some, like Norman Daniels, a healthy state is the absence of disease whereas for others, such as the World Health Organization (WHO), it is “a state of complete physical, mental and social well-being.”[1] These two definitions of a healthy state are clearly not identical and there exist similarly differing opinions on what is considered ‘beyond’ healthy, as well.

The article is here.

Thursday, September 24, 2015

The murky morality of biobanking

By Sarah Wild
Mail & Guardian
Originally published September 6, 2015

Here is an excerpt:

Yet biobanks are not mentioned in South Africa’s National Health Act of 2003, which governs human tissue usage, for therapies or research. Department of health deputy director general Terence Carter told the Mail & Guardian that workshops are planned to plug holes in the current law and regulations, and that ethicists will be included in these discussions.

This is “a scientific tissue issue, but also a major ethical issue, so we are bringing together the experts in ethics as well as cell technologies and genetics”, Carter said.

A major question in this area is the notion of consent, and what it means to give informed consent.

“Informed consent has different applications,” says the deputy dean of law at the University of South Africa, Professor Melodie Slabbert. “[You have] medical treatments on the one hand, such as between doctor and patient, and research between research participant and researcher on the other … Consent has specific legal requirements for it to be regarded lawful and valid consent.”

The entire article is here.

Friday, May 22, 2015

Expansion of ‘Right to Try’ legislation raises ethical, safety concerns

By HemOnc Today
Originally published April 25, 2015

Early access to experimental drugs has historically been reserved for patients enrolled on clinical trials.

In 2009, the FDA revamped its 1980’s expanded access program, which allows terminally ill patients ineligible for clinical trials and for whom no alternative, approved therapies exist to ask pharmaceutical companies for access to an investigational drug in their pipeline. More than 1,500 patients received an experimental treatment through the FDA’s program in 2014.

Now, some legislatures are going a step further by adopting so-called “Right to Try” legislation, intended to give terminally ill patients comparable access to investigational drugs but removing the FDA from the process.

Since 2014, thirteen states have passed Right to Try laws, and legislators in 20 more states have plans to introduce similar legislation this year.

The entire article is here.

Sunday, January 22, 2012

Meadowlands hospital neuroscientist fired over controversial autism treatment

By Susan K. Livio
The Star Ledger
Originally published January 10, 2012

Philip DeFina, PhD
The neuroscientist who would have overseen a controversial therapy for children with autism has been fired by Meadowlands Hospital Medical Center in Secaucus and, in a separate action, his nomination to a state commission on brain research has been delayed.

Philip DeFina was part of an ambitious plan by Meadowlands to offer hyperbaric oxygen therapy to children diagnosed with autism. The therapy, typically used to treat burns and other wounds by energizing dying tissue, required approval from the state Department of Health and Senior Services. Meadowlands would have been the first hospital in the state to offer the experimental treatment.

But the application ran into strong opposition, and questions were raised in a Nov. 27 Star-Ledger article in which traditional medical and psychological experts said the treatment offers families false hope while draining bank accounts because the experimental therapy is not covered by insurance. Some families say it has helped their children, and argued that if a method is safe and seems to be effective, it should be given a chance even if it hasn’t been thoroughly vetted through research.

The article also described DeFina’s doctorate in clinical psychology from Fielding Graduate University. The school, a mainly online university with monthly in-person sessions, is the only one to receive national accreditation from the American Psychological Association. DeFina’s experimental treatments with neurologist Jonathan Fellus for coma and brain injury have fetched as much as $100,000 from the families of patients who have not improved using traditional means. Fellus remains at Meadowlands.

There rest of the article is here.