Tag: drugs

Bioethics Blogs

Right to Try: Why Logic and Facts Won’t Win This One

by Craig Klugman, Ph.D.

Last week the U.S. Senate passed bill S. 204, the Trickett Wendler Right to Try Act of 2017. Trickett Wendler was a woman with ALS. The ALS association and her family lobbied Congress to support this bill to give all patients living with a terminal illness the “right” to purchase experimental drugs from pharmaceutical companies. Essentially, this bypasses the FDA’s compassionate use program. Instead of filing an application for FDA compassionate use (which the FDA approves 99% of the time), the patient asks the drug manufacturer directly. As I have written in this space before, such laws threaten public health efforts through the FDA to ensure safe and efficacious pharmaceuticals.

Currently, 37 states have such right-to-try laws and more have considered them. The push for these laws begins with the Barry Goldwater Institute, a libertarian think-tank, funded in part by the Koch brothers. Last month I had the surreal experience of debating two right-to-try supporters (one from a business school and one from the Goldwater Institute) about these laws which they base in a “right to self-medicate.” There were two of us against self-medication and two in favor of it.  You can read the commentaries and responses of the debaters here.

In this essay, I do not plan to restate my arguments against right-to-try. You can read my thoughts on this policy here and here. Instead, this post will examine the tools of argumentation that my opponents employed in the debate. It is important to show their debate techniques so that we all have a better understanding of how to analyze claims to support right-to-try and to realize why better facts and better arguments are falling on deaf ears.

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 Opioid Epidemic is an Epidemic of Stigma

Kristie Serota and Daniel Z. Buchman argue that eradicating the stigma associated with opioid use is an ethical necessity and is critical for population health.

__________________________________________

The Government of Canada reports that over 2458 Canadians died of apparent opioid-related deaths in 2016 (excluding Quebec). Last November, an average of 4 people died from overdoses every day in British Columbia. Recent U.S. estimates project opioid-related deaths at over half-a-million people over the next decade. Interventions have been implemented in many jurisdictions to minimize opioid-related mortality, but each year the death toll continues to rise and shows no signs of relenting.

While people dying from opioids in large numbers is not new, the present epidemic arose due to several complex factors. For example, OxyContin was aggressively marketed and prescribed for chronic non-cancer pain. Doctors and the public were misled about OxyContin’s addiction risks. In addition, health professionals receive limited training on pain and addiction. There are also inequities due to the social determinants of health and the harmful effects of substance use-related stigmas.

Stigma, operating at individual, institutional, and social levels, has led to punitive legal, policy, and clinical responses toward people who use drugs. Stigma has also led to chronic underfunding of addiction research and treatment services relative to the burden of disease. Although the current epidemic does not discriminate across the social gradient, stigma disproportionately burdens people from less privileged social groups more frequently and harmfully than others. People with no history of a substance use disorder risk the pejorative label of ‘addicts’ when they are prescribed opioids for pain management.

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 – July 2017 by Danya Glabau

American Quarterly

Regina Kunzel

Among the central themes of the eclectic field of mad studies is a critique of psychiatric authority. Activists and academics, from a range of positions and perspectives, have questioned psychiatry’s normalizing impulses and have privileged mad-identified knowledges over expert ones. One of the most successful assaults on psychiatric authority was launched by gay activists in the 1960s and early 1970s, resulting in the removal of homosexuality from the American Psychiatric Association’s (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM) in 1973. But if that event marked an inspirational victory against psychiatric power, it was also, as Robert McRuer notes, “a distancing from disability.”1Revisiting this history through analytic lenses offered by disability and mad studies defamiliarizes familiar historical narratives and unsettles the critique of psychiatric authority, especially when countered by claims to health.

 

Conflicts over the value, meaning, and efficacy of vaccination as a preventive practice suggest that vaccination resistance stages disagreement within modern biological citizenship. This paper explores how immunity circulates in both vaccination controversy and biopolitical philosophies. Two positions—one characterized by somatic individualism, flexible bodies, reflexive approaches to knowledge, and the idea of the immune system as “the essential relation the body has with its vulnerability,” and another characterized by the immunitary paradigm, biosecurity, trust in expert systems, and vaccination—emerge. Understanding that oppositional relation can reframe public understanding of vaccine skepticism and public health responses to it.

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

After French Drug Trial Tragedy, EU Issues New Rules to Protect Study Volunteers

August 4, 2017

Be the first to like.
Share

The European Medicines Agency (EMA) has issued new, stricter rules for studies that test drugs in people for the first time. They aim to better protect participants in such first-in-human studies—often healthy volunteers who receive a financial reward.

The guideline, which was issued on 25 July, will take effect in February 2018. It comes in the wake of a tragedy in a French drug study last year that led to the death of one man and serious neurological damage in four others. But some say the revision isn’t going for enough.

The new guideline emphasizes that drug developers must perform comprehensive preclinical tests of a new compound, including how it binds to its target and whether it has so-called off-target effects; experts argue such studies fell short for the French study. EMA also provides more detailed guidance on dosing and how to monitor subjects’ safety. Trial sponsors need to have strategies to minimize risks at every step and have to deal with adverse events timely and adequately.

… Read More

Be the first to like.
Share

Science Magazine

Tags: , , , , , , , , ,

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 Much Should Your Boss and the U.S. Department of Labor Know About Your Opioid Prescription History?

As the
price of health care and uncertainty about health insurance coverage increases,
employers are taking more of an interest in their employees’ health. Indeed,
this is not a new trend as the United States health insurance system has been
employment-based since its creation. However, this trend may seem more
justifiable when the federal government also takes an interest in employees’
health.  From a public health
perspective, monitoring a society’s health is very important but it must be
balanced against the individual’s privacy interest as well as the harms and
benefits of that monitoring. There is also the issue of who/what is the most
appropriate entity to be doing the monitoring.

On June
27, 2017,
the
United States Department of Labor announced
it
will officially be
monitoring
use of opioid prescriptions by workers
under the
Federal Employees’ Compensation Act, which is the law surrounding the worker’s
compensation system.  The announcement
expressed a safety concern based on overdoses and addiction of opioids in the
midst of our current opioid crisis.

When an
employee files a worker’s compensation claim,
the
employer must be notified
and the employer
has access to the health records included in that claim
.
The employer’s access to health records is limited to whatever is included in
the claim and is justified based on the premise that the employer has an
interest in the worker’s compensation claim. However, this new monitoring
system means that an employer will now have access to its employees’ opioid
prescription history, as this is information the U.S. Department of Labor will
be monitoring as part of the worker’s compensation process.

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 Much Should Your Boss and the U.S. Department of Labor Know About Your Opioid Prescription History?

As the
price of health care and uncertainty about health insurance coverage increases,
employers are taking more of an interest in their employees’ health. Indeed,
this is not a new trend as the United States health insurance system has been
employment-based since its creation. However, this trend may seem more
justifiable when the federal government also takes an interest in employees’
health.  From a public health
perspective, monitoring a society’s health is very important but it must be
balanced against the individual’s privacy interest as well as the harms and
benefits of that monitoring. There is also the issue of who/what is the most
appropriate entity to be doing the monitoring.

On June
27, 2017,
the
United States Department of Labor announced
it
will officially be
monitoring
use of opioid prescriptions by workers
under the
Federal Employees’ Compensation Act, which is the law surrounding the worker’s
compensation system.  The announcement
expressed a safety concern based on overdoses and addiction of opioids in the
midst of our current opioid crisis.

When an
employee files a worker’s compensation claim,
the
employer must be notified
and the employer
has access to the health records included in that claim
.
The employer’s access to health records is limited to whatever is included in
the claim and is justified based on the premise that the employer has an
interest in the worker’s compensation claim. However, this new monitoring
system means that an employer will now have access to its employees’ opioid
prescription history, as this is information the U.S. Department of Labor will
be monitoring as part of the worker’s compensation process.

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

Guess Who’s Tracking Your Prescription Drugs?

August 3, 2017

Be the first to like.
Share

As drug overdose deaths continue their record climb, Missouri last month became the 50th state to launch a prescription drug monitoring program, or PDMP. These state-run databases, which track prescriptions of certain potentially addictive or dangerous medications, are widely regarded as an essential tool to stem the opioid epidemic. Missouri Gov. Eric Greitens last month announced he was creating one in what had been the lone holdout state; legislative efforts to establish a program there had repeatedly failed because of lawmakers’ concerns about privacy.

Their concerns were not unfounded.

Federal courts in Utah and Oregon recently ruled that the Drug Enforcement Administration, in its effort to investigate suspected drug abusers or pill mills, can access information in those states’ PDMPs without a warrant, even over the states’ objections. And last month in California, the state supreme court ruled that the state medical board could view hundreds of patients’ prescription drug records in the course of its investigation of a physician accused of misconduct. “Physicians and patients have no reasonable expectation of privacy in the highly regulated prescription drug industry,” District Judge David Nuffer wrote in the Utah case.

… Read More

Image via Flickr Attribution Some rights reserved by sfxeric

Be the first to like.
Share

The Marshall Project

Tags: , , , , , , , , , ,

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

Sterilization for Prisoners Is Not New and Shows That Studying History is Essential

by Craig Klugman, Ph.D.

In 1927, Supreme Court Justice Oliver Wendell Holmes ruled that Carrie Buck and her baby could be sterilized because of a perception that they were “mental defectives.” In the 20th century, 32 states had federally funded programs that sterilized “undesirable” populations. Approximately 60,000 people in the U.S. were sterilized without their consent or even knowledge of the procedure. This history made an unexpected reappearance last week when a Tennessee judge offered to reduce the jail sentences of prisoners if they underwent sterilization.

The inmates were offered vasectomies (males) or contraceptive implants (females) in exchange for him shaving 30 days off of their prison sentences. The offer was popular as 70 inmates signed up (32 women and 38 men). The inmates were convicted of drug offenses and Judge Sam Benningfield said he was offering them “an opportunity to take personal responsibility and give them a chance, when they do get out, to not to be burdened with children…This gives them a chance to get on their feet and make something of themselves.”

The primary purpose in this was to try to reduce the number of children born drug dependent or suffering the consequence of in vitro drug exposure…the number of children who would eventually wind up in foster care,” the Judge said in a statement. He claims that the offer was “strictly voluntary…no one is forced to participate…it is no way a eugenic program.” Of course, the Judge presumes that inmates have true freedom of choice in this matter.

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

Advances in Neuroscience Strengthen Ethical Opposition to Harmful Experiments on Dogs

Guest Post: Jarrod Bailey, Cruelty Free International, London, UK.

Paper: Advances in Neuroscience Imply that Harmful Experiments in Dogs are Unethical

More than 200,000 dogs are used in harmful experiments every year worldwide, in research into human and animal diseases and in the testing of new drugs and agrochemicals. This continues despite significant public opposition to it, and of increasing scientific evidence of its poor human relevance and misleading nature. From a utilitarian perspective, these alter the harm-to-benefit balance of using dogs in experiments. If experiments on dogs cause more suffering than is commonly appreciated, and if they are not delivering the human benefits that are claimed of them, then these experiments must be reconsidered by those who fund, license, and conduct them.

But how do we know how much dogs can suffer, and how much joy they can experience and are thus deprived of in a laboratory? Many would argue that it is simply obvious that dogs have impressive cognitive capabilities, as well as experiencing positive and negative emotions. This is not enough for science, of course, which seems unable or unwilling to accept sentience in nonhumans as it does for humans, based on weight of evidence. For many years, efforts to understand the minds of dogs in more detail have centred on ethological research which, while extremely valuable, does have some associated, widely acknowledged caveats. It can only go so far, especially for those for whom the evidence it produces can perhaps never be sufficient to warrant a change of attitude and behaviour towards dogs.

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.