Tag: drugs

Bioethics News

Neuroscience Offers Insights Into the Opioid Epidemic

July 21, 2017

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Most Americans say they’re interested in scientific discoveries, but they may be thinking of the kinds of findings that lead to new gadgets and wonder drugs. When it comes to discoveries about hazards and risks — especially the risks of those wonder drugs — Americans seem more likely to tune out.

Such ambivalence might help explain how opioid misuse became such a problem in America. Despite 20 years of warnings from scientists about the dangers of addiction, the rate of prescriptions has tripled between 1999 and today. It hit a peak around 2012 and has started to decline slightly, going from 81.2 per 100 people to a still-enormous 70.6 per 100, new data show. Indeed, according to the Centers for Disease Control and Prevention, U.S. doctors wrote 259 million prescriptions for potentially addictive painkillers in 2014 — enough for every adult in the country to have a bottle.

All the while, neuroscientists have found that opioids can cause long-term changes in the brain even after an addicted person experiences the severe nausea and other withdrawal symptoms typically associated with quitting. That lingering hazard might have given patients and prescribing physicians pause.

Image: By PNAS – doi: 10.1073/pnas.1117206109, CC BY 2.5 br, https://commons.wikimedia.org/w/index.php?curid=18829817

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Bloomberg View

Tags: addiction, bioethics, free will, neuroethics, neuroscience, recovery, treatment

Source: Bioethics Bulletin by the Berman Institute of Bioethics.

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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 News

Zika Rewrites Maternal Immunization Ethics

July 20, 2017

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Ever since the shocking realization in 1961 that the morning sickness pill thalidomide caused shortened limbs in babies, doctors have been extremely wary of giving any medicine to a pregnant woman—and testing experimental drugs has raised even more concerns. But the recent discovery that exposure to Zika virus in utero can cause severe brain damage and other problems in children triggered an international effort to develop a vaccine for pregnant women. A new report written by an ad hoc group of prominent researchers, bioethicists, clinicians, and drugmakers concludes that pregnant women should be included in trials of Zika vaccines, once safety in animals and nonpregnant adults is demonstrated. The risk/benefit issues spelled out in the report also apply to experiments with maternal immunization for other diseases, which are winning increasing support.

Researchers have been too reticent to include pregnant women in clinical trials of vaccines, contends the working group behind the report. “Even for the vaccines we now recommend in pregnancy, pertussis and flu, the original trials did not include pregnant women,” says Carleigh Krubiner, a bioethicist at the Johns Hopkins Berman Institute of Bioethics in Baltimore, Maryland, who is part of the group, which was sponsored by the London-based Wellcome Trust. “This project is trying to be more proactive.”

The half-dozen Zika vaccine trials now taking place only enroll women of childbearing age who are on contraception or have a sterile male partner. That is appropriate, according to the risk/benefit analyses spelled out in the report, as these early studies assess only safety and basic immune responses.

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Bioethics News

Excluding Pregnant Women From Clinical Studies Because They’re Classed As ‘Vulnerable’ Is ‘Harmful’

July 20, 2017

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Excluding mums-to-be from clinical studies is unfair and could be potentially harmful, researchers have said.

Pregnant women are often ruled out of participating in clinical trials because they’re classified as a “vulnerable” group, and this creates a knowledge void around the impact of drugs taken during pregnancy and “unfairly excludes” them from taking part in clinical studies, concluded researchers writing in the ‘Journal of Medical Ethics’.

“There is a desperate need to shift the paradigm to protect pregnant women through research, not just from research,” the researchers wrote.

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HuffPost UK

Tags: bioethics, carleigh krubiner, inclusion, pregnancy, pregnant, research, Research Ethics, Ruth Faden, subject, vulnerable, woman

Source: Bioethics Bulletin by the Berman Institute of Bioethics.

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Bioethics Blogs

Another Milestone in the Cystic Fibrosis Journey

Caption: Two-year-old Avalyn is among the cystic fibrosis patients who may be helped by targeted drugs.
Credit: Brittany Mahoney

As NIH Director, I often hear stories of how people with serious diseases—from arthritis to Zika infection—are benefitting from the transformational power of NIH’s investments in basic science. Today, I’d like to share one such advance that I find particularly exciting: news that a combination of three molecularly targeted drugs may finally make it possible to treat the vast majority of patients with cystic fibrosis (CF), our nation’s most common genetic disease.

First, a bit of history! The first genetic mutation that causes CF was discovered by a collaborative effort between my own research lab at the University of Michigan, Ann Arbor, and colleagues at the Hospital for Sick Children in Toronto—more than 25 years ago [1]. Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). Very recently new technologies, such as cryo-EM, have given researchers the ability to map the exact structure of the protein involved in CF.

Among the tens of thousands of CF patients who stand to benefit from the next generation of targeted drugs is little Avalyn Mahoney of Cardiff by the Sea, CA. Just a few decades ago, a kid like Avalyn—who just turned 2 last month—probably wouldn’t have made it beyond her teens. But today the outlook is far brighter for her and so many others, thanks to recent advances that build upon NIH-supported basic research.

Bioethics News

The Myth of Drug Expiration Dates

July 18, 2017

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This story was co-published with NPR’s Shots blog.

The box of prescription drugs had been forgotten in a back closet of a retail pharmacy for so long that some of the pills predated the 1969 moon landing. Most were 30 to 40 years past their expiration dates — possibly toxic, probably worthless.

But to Lee Cantrell, who helps run the California Poison Control System, the cache was an opportunity to answer an enduring question about the actual shelf life of drugs: Could these drugs from the bell-bottom era still be potent?

Cantrell called Roy Gerona, a University of California, San Francisco, researcher who specializes in analyzing chemicals. Gerona had grown up in the Philippines and had seen people recover from sickness by taking expired drugs with no apparent ill effects.

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ProPublica

Tags: benefits, bioethics, costs, expiration, health policy, medication, medicine, pharma, pharmacy, potency, public health, risks, safety, testing, uncertainty

Source: Bioethics Bulletin by the Berman Institute of Bioethics.

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Bioethics Blogs

The Zika Vaccine Research Agenda & Pregnant Women

The Ethics Working Group on ZIKV Research & Pregnancy provides recommendations to ensure that pregnant women are responsibly and equitably included in the Zika virus vaccine research and development agenda.

__________________________________________

Zika virus vaccine development is proceeding rapidly, with a number of vaccine candidates already moving into Phase II clinical trials. These are trials that are designed to look for evidence of efficacy.

As the public health community races to develop Zika virus vaccines, now is a critical time to ensure that research and development efforts adequately address the needs of pregnant women and their offspring. To this end, the Ethics Working Group on ZIKV Research & Pregnancy, an interdisciplinary group of international experts in vaccinology, maternal and child health, public health and ethics, has developed Ethics Guidance for including the needs and interests of pregnant women and their offspring in the Zika virus vaccine research and development agenda: Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence Generation.

A vial of the NIAID Zika Virus Investigational DNA Vaccine, taken at the NIAID Vaccine Research Center’s Pilot Plant in Frederick, Maryland. Credit: NIAID

This Ethics Guidance argues that global concern about the devastating effects of Zika virus infection in pregnancy for normal fetal development, pregnant women and their offspring is not enough. Pregnant women and their babies should also be front and center in Zika virus vaccine development.

Unless specific actions recommended by the Working Group are taken soon, pregnant women and their offspring will not be able to share fairly in the benefits of whichever vaccines prove efficacious.

Bioethics News

Charlie Gard, the sick baby hospital doctors want to disconnect. Our medical and ethical assessement

He and his parents await the Judge’s decision regarding the possibility of withdrawing or not the life support who keep him alive and the possibility of receiving an experimental treatment in the United States

Medical aspects

Charlie was born on 4 August 2016. In October the same year, he was admitted to Great Osmond Street Hospital (GOSH-NHS) in London, and diagnosed with a disease that affects mitochondrial function, called mitochondrial DNA depletion syndrome (MDDS). This means that he cannot obtain sufficient energy for his muscles, kidneys, brain and other organs, which causes progressive muscle weakness and brain damage.

Although there seemed to be no specific treatment for the mitochondrial abnormality at that time, in January 2017, his mother became aware of an experimental treatment using nucleosides that was being evaluated in the United States in patients with a disease similar to Charlie’s. Consequently, his parents assessed the possibility of taking him to the US for treatment because, according to them, it might improve their son’s health by at least 10%.

At the same time, British newspaper “The Guardian” announced that the US Hospital that had the medication offered to ship it so that Charlie could be treated immediately, but GOSH (NHS hospital) disagreed, proposing instead to withdraw the child’s respiratory support.

In effect, New York-Presbyterian Hospital and Irving Medical Center, also in New York, published a statement saying that they were willing to admit and clinically evaluate Charlie, as they had FDA approval for the use of an experimental treatment using nucleosides.

Bioethics News

Memory-Enhancing Drug Reverses Effects of Traumatic Brain Injury In Mice

Whether caused by a car accident or repeated blows to your cranium from high-contact sports, traumatic brain injury can be permanent. There are no drugs to reverse the cognitive decline and memory loss, and any surgical interventions must be carried out within hours to be effective, according to the current medical wisdom. But a compound previously used to enhance memory in mice may offer hope

Source: Bioethics Bulletin by the Berman Institute of Bioethics.

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Bioethics News

Religious Leaders Get High on Magic Mushroom Ingredient – For Science

July 11, 2017

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A Catholic priest, a Rabbi and a Buddhist walk into a bar and order some magic mushrooms. It may sound like the first line of a bad joke, but this scenario is playing out in one of the first scientific investigations into the effects of psychedelic drugs on religious experience – albeit in a laboratory rather than a bar.

Scientists at Johns Hopkins University in Baltimore have enlisted two dozen religious leaders from a wide range of denominations, to participate in a study in which they will be given two powerful doses of psilocybin, the active ingredient in magic mushrooms.

Dr William Richards, a psychologist at Johns Hopkins University in Baltimore, Maryland who is involved in the work, said: “With psilocybin these profound mystical experiences are quite common. It seemed like a no-brainer that they might be of interest, if not valuable, to clergy.”

Image: By Arp – This image is Image Number 6514 at Mushroom Observer, a source for mycological images.This tag does not indicate the copyright status of the attached work. A normal copyright tag is still required. See Commons:Licensing for more information., CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=12066335

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The Guardian

Tags: bioethics, hallucination, Johns Hopkins, mushroom, neuroethics, religious experience, spirituality

Source: Bioethics Bulletin by the Berman Institute of Bioethics.

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Bioethics Blogs

Never Let an Ill Child Go to Waste

The Charlie Gard saga is one about which I’ve been reluctant to say anything, not least because plenty of other people have said plenty elsewhere. Sometimes they add heat, and sometimes they add light.

Beneath everything, the story is fairly simple: a small child is terribly ill; it is agreed by medical opinion that continued treatment is not only not in his best interests but would cause him positive harm; the courts have determined that the withdrawal of treatment is warranted. One sympathises with his parents’ fight to keep treatment going – but it does not follow from that that their opinions should be determinative. Indeed, the courts having decided that Charlie’s treatment should not be withdrawn immediately in order to allow his parents more time with him risks making the case about them, rather than about him. If treatment is not medically warranted and actually is harmful, there may be something worrisome about continuing it anyway for the sake of his parents. Their distress is not going to lessened by prolonging the child’s treatment, and even if it were, it is not the proper focus here.

So that’s my hot take on the story itself. I don’t think it’s anything too radical. Yet the coverage of the case has been, in places, something of a trainwreck. Take, for example, this piece from the Chicago Tribune (with thanks to Charles Erin for the pointer). It’s fascinating for just how much it manages to get wrong, and how mawkish it is, and for what it does with the story to such unpleasant ends.