Tag: therapeutics

Bioethics Blogs

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant … Continue reading

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

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant … Continue reading

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

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to … Continue reading

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

Revising the Ethical Framework for Deep Brain Stimulation for Treatment-Resistant Depression

By Somnath Das

Somnath Das recently graduated from Emory University where he majored in Neuroscience and Chemistry. He will be attending medical school at Thomas Jefferson University starting in the Fall of 2017. Studying Neuroethics has allowed him to combine his love for neuroscience, his interest in medicine, and his wish to help others into a multidisciplinary, rewarding practice of scholarship which to this day enriches how he views both developing neurotechnologies and the world around him. 

Despite the prevalence of therapeutics for treating depression, approximately 20% of patients fail to respond to multiple treatments such as antidepressants, cognitive-behavioral therapy, and electroconvulsive therapy (Fava, 2003). Zeroing on an effective treatment of “Treatment-Resistant Depression” (TRD) has been the focus of physicians and scientists. Dr. Helen Mayberg’s groundbreaking paper on Deep Brain Stimulation (DBS) demonstrates that electrical modulation an area of the brain called subgenual cingulate resulted in a “sustained remission of depression in four of six (TRD) patients” These patients experienced feelings that were described as “lifting a void,” or “a sudden calmness.” (Mayberg et al. 2005). The importance of this treatment lies in the fact participants who received DBS for TRD (DBS-TRD) often have no other treatment avenues, and thus Mayberg’s findings paved the way for DBS to have great treatment potential for severely disabling depression. 

Image courtesy of Wikimedia Commons
Because DBS involves the implantation of electrodes into the brain, Dr. Mayberg and other DBS researchers faced intense scrutiny following publication of their initial findings regarding the ethics of using what to some seems like a dramatic intervention for TRD.

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 Neuroethics Blog Series on Black Mirror: Be Right Back

By Somnath Das
Somnath Das recently graduated from Emory University where he majored in Neuroscience and Chemistry. He will be attending medical school at Thomas Jefferson University starting in the Fall of 2017. The son of two Indian immigrants, he developed an interest in healthcare after observing how his extended family sought help from India’s healthcare system to seek relief from chronic illnesses. Somnath’s interest in medicine currently focuses on understanding the social construction of health and healthcare delivery. Studying Neuroethics has allowed him to combine his love for neuroscience, his interest in medicine, and his wish to help others into a multidisciplinary, rewarding practice of scholarship which to this day enriches how he views both developing neurotechnologies and the world around him. 
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Humans in the 21st century have an intimate relationship with technology. Much of our lives are spent being informed and entertained by screens. Technological advancements in science and medicine have helped and healed in ways we previously couldn’t dream of. But what unanticipated consequences may be lurking behind our rapid expansion into new technological territory? This question is continually being explored in the British sci-fi TV series Black Mirror, which provides a glimpse into the not-so-distant future and warns us to be mindful of how we treat our technology and how it can affect us in return. This piece is part of a series of posts that will discuss ethical issues surrounding neuro-technologies featured in the show and will compare how similar technologies are impacting us in the real world. 

*SPOILER ALERT* – The following contains plot spoilers for the Netflix television series Black Mirror

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

Insurers Battle Families Over Costly Drug for Fatal Disease

June 23, 2017

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Nolan and Jack Willis, twins from upstate New York, and just 10 other boys took part in a clinical trial that led to the approval last fall of the very first drug to treat their rare, deadly muscle disease.

Now the Willis boys are again test cases as a different type of medical question comes to the fore: whether insurers will cover the controversial drug, Exondys 51, which can cost more than $1 million a year even though it’s still unclear if it works.

The boys’ insurer, Excellus BlueCross BlueShield, refused to cover the cost of the drug because the twins, who are 15, can no longer walk. Their disease, Duchenne muscular dystrophy, overwhelmingly affects boys and causes muscles to deteriorate, killing many of them by the end of their 20s.

“I’m cycling between rage and just sadness,” their mother, Alison Willis Hoke, said recently, on the day she learned that an appeal for coverage had been denied. For now, the company that sells the drug, Sarepta Therapeutics, is covering the treatment’s costs, but Mrs. Hoke does not know how long that will last.

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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

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant … Continue reading

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

Guest Post: Crispr Craze and Crispr Cares

Written by Robert Ranisch, Institute for Ethics and History of Medicine, University of Tuebingen

@RobRanisch

Newly discovered tools for the targeted editing of the genome have been generating talk of a revolution in gene technology for the last five years. The CRISPR/Cas9-method draws most of the attention by enabling a more simple and precise, cheaper and quicker modification of genes in a hitherto unknown measure. Since these so-called molecular scissors can be set to work in just about all organisms, hardly a week goes by without headlines regarding the latest scientific research: Genome editing could keep vegetables looking fresh, eliminate malaria from disease-carrying mosquitoes, replace antibiotics or bring mammoths back to life.

Naturally, the greatest hopes are put into its potential for various medical applications. Despite the media hype, there are no ready-to-use CRISPR gene therapies. However, the first clinical studies are under way in China and have been approved in the USA. Future therapy methods might allow eradicating hereditary illnesses, conquering cancer, or even cure HIV/AIDS. Just this May, results from experiments on mice gave reason to hope for this. In a similar vein, germline intervention is being reconsidered as a realistic option now, although it had long been considered taboo because of how its (side)effects are passed down the generations.

The developmental history of genome editing reveals itself as a recalibration of ethical standards in research. Two years ago, the first-time use of these new tools on (non-viable) embryos in China led to a solid scandal; in retrospect, it is not clear anymore whether the outrage was triggered by ethical concerns or by the circumstance that this (perceived) taboo was broken by China of all countries.

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

All Scientific Hands on Deck to End the Opioid Crisis

In 2015, 2 million people had a prescription opioid-use disorder and 591,000 suffered from a heroin-use disorder; prescription drug misuse alone cost the nation $78.5 billion in healthcare, law enforcement, and lost productivity. But while the scope of the crisis is staggering, it is not hopeless.

We understand opioid addiction better than many other drug use disorders; there are effective strategies that can be implemented right now to save lives and to prevent and treat opioid addiction. At the National Rx Drug Abuse and Heroin Summit in Atlanta last April, lawmakers and representatives from health care, law enforcement, and many private stakeholders from across the nation affirmed a strong commitment to end the crisis.

Research will be a critical component of achieving this goal. Today in the New England Journal of Medicine, we laid out a plan to accelerate research in three crucial areas: overdose reversal, addiction treatment, and pain management [1].

First, there is a need to develop additional overdose-reversal interventions and improved formulations of naloxone to reduce mortality. Naloxone is very effective at reversing overdoses, but bystanders may not reach the person in time and the usual doses given may not be powerful or long-lasting enough to reverse overdoses on fentanyl and other highly potent synthetic opioids. In addition to new or differently formulated antagonists of the mu-opioid receptor, other targets such as the 5HT1A receptor (a serotonin receptor) may hold promise as alternative ways of reversing respiratory depression caused by opioid overdose.

Research is also needed to develop technologies that can detect an overdose and signal for help as well as intervene automatically to stimulate respiration.

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

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or … Continue reading

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.