Tag: regulation

Bioethics Blogs

A Modest Proposal

FDA should regulate digital games, and potentially other apps, as medical devices.

Why, pray tell?

One doesn’t have to look very hard to find a growing belief (recognition?) that video games are addicting.  CBS has been on the story since at least 2007.  In 2014, “60 minutes” suggested that a violent video game could prompt murder.  Well, they posed it as a question, but to raise it as they did sounds kind of like asking someone, “have you stopped beating your wife?”  And this past April, they did a piece with a former Google employee who suggested that tech companies are designing games, if not apps in general, to draw people into compulsive use.  They revisited the topic, with the same interviewee, in June, using the term “brain hacking.”  Frontline on PBS did a series on the topic in 2010, looking at concerns about internet addiction as well as arguments that some games may hone desirable skills.

Concern about the effect our entertainment media have on us, especially on our kids, is certainly not new.  Remember Tipper Gore, who, among other things, wrote a book about the subject 30 years ago?

The difference comes if our apps and games are not just addictive and self-reinforcing, but if their creators and marketers not only know it but make them that way on purpose.

According to the FDA, a medical device, subject to premarketing and postmarketing regulatory controls by the FDA, is defined in Section 201(h) of the Food, Drug, and Cosmetic Act as (emphasis mine in what follows):

  • “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

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 News

New State Network against surrogate motherhood in Spain

Alicia Miyares is a feminist philosopher and writer. For a couple of years now, she has been involved in the movement “No somos Vasijas” (We are not vessels), together with other philosophers such as Amelia Valcárcel and Victoria Camps, dedicating a large part of her time fighting against surrogacy. Use a Surrogate mother to have a child is currently banned in Spain, although its possible regulation has entered fully into the political debate. Miyares spares no criticism for what she understands as no more than a euphemism under which hides a business that is degrading for women, by reducing them to mere reproductive machines. In the last week of April, Miyares and 50 women’s organizations and LGTBI groups presented the Red Estatal contra el Alquiler de Vientres (State Network against Surrogacy) at a press conference in Madrid. The surrogation site makes his position clear: “We are not incubators, nor vessels, nor uteruses nor wombs for rent: we are women, human lives with which some people are trying to set up a new business that will benefit the strongest and suppress the weakest” (See HERE the site)

La entrada New State Network against surrogate motherhood in Spain aparece primero en Bioethics Observatory.

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

Talking back to science?

By Stephen Rainey

In June 2017, the European Court of Justice ruled that it was legal for a French citizen to sue a drug company for damages following a vaccination, and an illness. The ruling caused some consternation as it seemed a legal vindication of anecdote over scientific rigour.

This is a dramatic case, not least owing to the position in which vaccines find themselves, post Andrew Wakefield and the rise of the anti-vaxxer movement. Nevertheless, it forms a part of a wider narrative in which scientific activity is not always very open to questions from outside science. This broader theme is worth some scrutiny.

Vaccine injury

Shortly following a vaccination against Hepatitis B a French citizen, JW, found himself in declining health. Soon after the decline began, a diagnosis of Multiple Sclerosis (MS) was made. Having had no prior personal or family history of such an illness, and having been in good health prior to the inoculation, JW concluded that the injections must have been to blame for his developing MS. His assertion of this was not supported by scientific investigation. Rather, he could think of the vaccination as the only unusual event that preceded closely his sudden, unexpected development of the condition.

The French courts found themselves unable to agree on whether such a basis as this is sufficient to sue a pharmaceutical company. Eventually, the case was sent to the European Court of Justice (ECJ) which ruled,

“…that the temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of that disease, together with the existence of a significant number of reported cases of the disease occurring following such vaccines being administered, appears on the face of it to constitute evidence which, taken together, may lead a national court to consider that a victim has discharged his burden of proof.

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

Ethics & Society Newsfeed: August 18, 2017

Image via 

Politics

Neil Gorsuch Speech at Trump Hotel Raises Ethical Questions
“Justice Neil M. Gorsuch, President Trump’s Supreme Court appointee, is scheduled to address a conservative group at the Trump International Hotel in Washington next month, less than two weeks before the court is set to hear arguments on Mr. Trump’s travel ban.”

Trump’s Washington DC hotel turns $2m profit amid ethics concerns
“Donald Trump’s company is said to have taken home nearly $2m in profits this year at its extravagant hotel in Washington, DC – amid ethics concerns stemming from the President’s refusal to fully divest from his businesses while he is in office.”

3 representatives want to officially censure Trump after Charlottesville
“In response to Donald Trump’s controversial remarks about the violence in Charlottesville, Virginia, three Democrats want to censure the president.”

Does Trump’s Slippery Slope Argument About Confederate Statues Have Merit?
“NPR’s Robert Siegal talks with Ilya Somin, a professor of George Mason University, about President Trump’s warning that pulling down Confederate statues may lead to a slippery slope in which monuments to the Founding Fathers are torn down.”

Bioethics/Medical Ethics and Research Ethics

Vaccination: Costly clash between autonomy, public health
Bioethical principles in conflict with medical exemptions to vaccinations

CRISPR and the Ethics of Human Embryo Research
“Although scientists in China and the United Kingdom have already used gene editing on human embryos, the announcement that the research is now being done in the United States makes a U.S. policy response all the more urgent.”

Exclusive: Inside The Lab Where Scientists Are Editing DNA In Human Embryos
“[Critics] fear editing DNA in human embryos is unsafe, unnecessary and could open the door to “designer babies” and possibly someday to genetically enhanced people who are considered superior by society.”

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

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 News

American CRISPR Experiments and the Future of Regulation

By Michael S. Dauber, MA, GBI Visiting Scholar

According to a report in The MIT Technology Review, researchers in a lab based in Portland, Oregon have successfully created genetically modified human embryos for the first time in U.S. history, using a technique called CRISPR. The project, directed by Shoukhrat Mitalipov, a researcher at Oregon Health and Science University, was published in Nature, and consisted of modifying the genes of human embryos to prevent a severe, genetically inherited heart condition. The embryos were destroyed several days after the experiments.

CRISPR stands for “clustered, regularly interspaced, short palindromic repeats.” It is a genetic editing technique that allows scientists to cut out pieces of DNA and replace them with other pieces. CRISPR originated as a naturally occurring cellular defense system in certain bacterial that allows a cell to defend itself from foreign genetic material injected into cells by viruses. RNA strands that match the problematic genes bind with the piece of DNA to be removed, and enzymes work to remove the defective material. When CRISPR is used to edit the human genome, scientists apply CRISPR RNA strands and the corresponding enzymes that match the genes they wish to edit in order to extract the problematic genes.

Mitalipov is not the first scientist to use CRISPR to edit the human genome. Scientists in China have been using the technique in research using human embryos dating back to 2015. One notable study consisted of attempts to make cells resistant to HIV. Another controversial study involved the injection of CRISPR-modified cells into a patient with advanced lung cancer.

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

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 Blogs

Human genome editing: We should all have a say

Françoise Baylis stresses that decisions about the modification of the human germline should not be made without broad societal consultation.

__________________________________________

Shoukhrat Mitalipov, a reproductive biologist at Oregon Health and Science University, is nothing if not a pioneer. In 2007, his team published proof-of-principle research in primates showing it was possible to derive stem cells from cloned primate embryos. In 2013, his team was the first to create human embryonic stem cells by cloning. Now, in 2017, his team has reported safely and effectively modifying human embryos with the MYBPC3 mutation (which causes myocardial disease) using the gene editing technique CRISPR.

Mitalipov’s team is not the first to genetically modify human embryos. This was first accomplished in 2015 by a group of Chinese scientists led by Junjiu Huang. Mitalipov’s team, however, may be the first to demonstrate basic safety and efficacy using the CRISPR technique.

This has serious implications for the ethics debate on human germline modification which involves inserting, deleting or replacing the DNA of human sperm, eggs or embryos to change the genes of future children.

Those who support human embryo research will argue that Mitalipov’s research to alter human embryos is ethically acceptable because the embryos were not allowed to develop beyond 14 days (the widely accepted international limit on human embryo research) and because the modified embryos were not used to initiate a pregnancy. They will also point to the future potential benefit of correcting defective genes that cause inherited disease.

This research is ethically controversial, however, because it is a clear step on the path to making heritable modifications – genetic changes that can be passed down through subsequent generations.

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.