Tag: marketing

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I <3 Intended Use (and why some new technologies may fall within FDA jurisdiction)

Cross-posted on Objective Intent

A few news stories over the past week or so—one in the Wall Street Journal about “neurotech,” one in Geek Gadget about “neuroscience wearables,” one in the Washington Post about baby monitors for measuring an infant’s vital signs, and one in Gizmodo about “vaginal wellness products” marketed on Etsy—reminded me how much I enjoy questions of intended use.  As I wrote more about here, intended use is a critical concept in FDA law, in part because a product’s intended use is crucial to determining whether it meets the law’s definition of drug or device within the FDA’s jurisdiction.  And, for whatever reason, I have an unabashed and—as far as I can tell—limitless love for thinking through questions about whether, and how, products fall with the definition of a drug or device.

As for the reported neurotech, neuro-wearable, baby monitor, and vaginal wellness products, it seems to me that many of these products may fall within the Federal Food, Drug, and Cosmetic Act’s (FDCA) definitions of drugs or devices.  Why is that?

The FDCA defines drugs and devices as products “intended for use” in the diagnosis, cure, mitigation, treatment, or prevention of diseases, or “intended to affect the structure or any function of the body.”  And this definition is very broad.

The “disease” piece of the definition captures things like cancer therapies and artificial heart valves—products that fit comfortably within what many commonly understand to be drugs and devices subject to FDA regulation.  But, because implicit claims about addressing disease can also cause a product to fall with the definition of a drug or device, this part of the definition also might capture things like baby monitors marketed as measuring breathing and oxygen levels.

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.

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Mailbag

Brief comments on four short articles from this week, on disparate topics:

James Capretta of the American Enterprise Institute (meaning he is politically right of center) pleads in the Journal of the American Medical Association (JAMA) for compromise between Republicans and Democrats on further healthcare policy reform.  Arguing that the House-passed American Health Care Act (AHCA) may never pass, he believes that a better result politically and for public policy would be if legislators could, in essence, split the difference between the AHCA and current law, the Affordable Care Act (ACA, aka “Obamacare”) on some points where he sees some agreements in principle.  He proposes: 1) a hybrid approach between the ACA’s income-based tax credits for health insurance purchase and the AHCA’s age-based approach; 2) ensuring continuous insurance coverage for people with pre-existing conditions by modifying the ACA’s penalties for not being insured to fall more heavily on higher-income people; 3) setting limits on the favorable tax treatment of employer-paid health insurance premiums; 4) automatically enrolling uninsured people into a bare-bones, no-premium plan from which they could opt out in favor of re-enrollment in a different plan (a proposal that sounds to me a lot like the Democrats’ “public option” with a guaranteed fight over scope of coverage); and 5) limiting Medicaid expansion to tie it to reform of the program (something that sounds to me a lot like what I understand is currently in the AHCA).  Mr. Capretta knows a lot more about health policy than I, and has been at it a lot longer. 

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.

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40th Annual Health Law Professors Conference

If you teach health law, come to the 40th Annual Health Law Professors Conference, June 8-10, 2017, at Georgia State University College of Law in Atlanta.  Here is the schedule:


Thursday, June 8, 2017
8:00-12:00 AM Tour of the Centers for Disease Control and Prevention (Separate registration is required. Participants meet in the lobby of Georgia State Law to take a shuttle to the CDC.)


9:45 – 11:15 AM Tour of Grady Health System (Separate registration is required. Participants meet in the lobby of Georgia State Law and will walk over to Grady as a group.)


2:00 – 5:00 PM Conference Registration – Henson Atrium, Georgia State Law


3:00 – 5:00 PM Jay Healey Teaching Session – Knowles Conference Center, Georgia State Law
Experiential Teaching and Learning in Health Law
The format for this session is World Café roundtables, with plenty of opportunity for the collegial exchange of teaching ideas and insights among your colleagues. Come prepared for a lively, interactive workshop.
World Café Hosts:
Dayna Matthew, University of Colorado Law School
Charity Scott, Georgia State University College of Law
Sidney Watson, Saint Louis University School of Law
Invited Discussants and Participants:
Rodney Adams, Virginia Commonwealth University School of Health Administration
Christina Juris Bennett, University of Oklahoma College of Law
Amy Campbell, University of Memphis Cecil C. Humphreys School of Law
Michael Campbell, Villanova University Charles Widger School of Law
Erin Fuse Brown, Georgia State University College of Law
Cynthia Ho, Loyola University of Chicago School of Law
Danielle Pelfrey Duryea, University of Buffalo School of Law, State University of New York
Jennifer Mantel, University of Houston Law Center
Elizabeth McCuskey, University of Toledo College of Law
Laura McNally-Levine, Case Western Reserve University School of Law
Jennifer Oliva, West Virginia University College of Law and School of Public Health
Thaddeus Pope, Mitchell Hamline School of Law
Lauren Roth, St.

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.

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The Deadly Business of an Unregulated Global Stem Cell Market

Guest Post: The deadly business of an unregulated global stem cell industry

Tereza Hendl and Tamra Lysaght

In our paper, we report on the case of a 75-year old Australian woman who died in December 2013 from complications of an autologous stem cell procedure. This case was tragic and worth reporting to the medical ethics community because her death was entirely avoidable and the result of a pernicious global problem – doctors exploiting regulatory systems in order to sell unproven and unjustified stem cell interventions.

The patient at the centre of this case, Sheila Drysdale, underwent a liposuction procedure administered by cosmetic surgeon, Dr Ralph Bright, at his private Sydney clinic. Dr Bright did not perform this procedure for cosmetic reasons, but rather to ‘treat’ her advanced dementia with adipose (fat) derived stem cells. Mrs Drysdale died within ten hours of the surgery. Following an inquest into her death, the New South Wales Deputy Coroner stated that the utilisation of stem cells to ‘treat’ dementia was “highly questionable” and displayed “some of the hallmarks of ‘quack’ medicine,” particularly owing to the lack of scientific evidence supporting such ’therapy.’ The Coroner, thus, called for a more rigorous regulation of ‘innovative’ medical procedures in Australia that would protect vulnerable patients. Sadly, the relevant regulatory authorities have done very little to bring about any justice for Mrs Drysdale, or to address the systemic problems in Australia’s legislative framework that allows medical professionals to offer unproven stem cell-based interventions to patients without any accountability.

This case came to our attention as part of the work being done on an Australian Research Council funded Linkage Project “Regulating autologous stem cell therapies in Australia.”

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.

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Bioethics & Wine

I
never thought I’d have the opportunity to use this blog title. Never, that is,
until I stumbled across a company called
Vinome, a California
start-up that offers a curated wine service based on a customer’s individual
taste profile. What makes this wine subscription service unique is not its
price (although, at around
$65 a bottle, it’s just a
bit outside of the typical price-per-bottle for many wine club members). At
Vinome, your taste profile includes not only a list of questions about your
preferences, but also information from DNA sequencing from the saliva sample
you provide to the company. The company website proclaims this is “A little
science and a lot of fun,” but
experts are skeptical about whether
there is any science involved at all.

Holding
aside the question of scientific plausibility, companies touting
direct-to-consumer genetic screening for ancestry, medical issues, or just
plain fun include information in the fine print that would give any bioethicist
pause. While the Vinome website requires patrons to check the box indicating “I
have read and understand the Vinome Informed Consent” prior to ordering, that “informed
consent” is only available if the customer
voluntarily
clicks on the informed consent link. Buried at the bottom of the informed
consent screen is a sentence that reads:

 

“You allow
Vinome to retain your data as part of Vinome’s secure research database, for
use by Vinome or its research affiliates, in an effort to improve and expand
services. If any commercial product is developed as a result of the use of your
data, there will be no financial benefit to you.”

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.

Uncategorized

Bioethics & Wine

I
never thought I’d have the opportunity to use this blog title. Never, that is,
until I stumbled across a company called
Vinome, a California
start-up that offers a curated wine service based on a customer’s individual
taste profile. What makes this wine subscription service unique is not its
price (although, at around
$65 a bottle, it’s just a
bit outside of the typical price-per-bottle for many wine club members). At
Vinome, your taste profile includes not only a list of questions about your
preferences, but also information from DNA sequencing from the saliva sample
you provide to the company. The company website proclaims this is “A little
science and a lot of fun,” but
experts are skeptical about whether
there is any science involved at all.

Holding
aside the question of scientific plausibility, companies touting
direct-to-consumer genetic screening for ancestry, medical issues, or just
plain fun include information in the fine print that would give any bioethicist
pause. While the Vinome website requires patrons to check the box indicating “I
have read and understand the Vinome Informed Consent” prior to ordering, that “informed
consent” is only available if the customer
voluntarily
clicks on the informed consent link. Buried at the bottom of the informed
consent screen is a sentence that reads:

 

“You allow
Vinome to retain your data as part of Vinome’s secure research database, for
use by Vinome or its research affiliates, in an effort to improve and expand
services. If any commercial product is developed as a result of the use of your
data, there will be no financial benefit to you.”

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.

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Genetic counselors, genetic interpreters, and conflicting interests

By Katie Stoll, Amanda Mackison, Megan Allyse, and Marsha Michie The booming genetic testing industry has created many new job opportunities for genetic counselors. Within commercial laboratories, genetic counselors work in sales and marketing, variant interpretation, as “medical science liaisons” … 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.

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Lenore Manderson, Elizabeth Cartwright and Anita Hardon’s The Routledge Handbook of Medical Anthropology by Casey Golomski

The Routledge Handbook of Medical Anthropology

Edited by Lenore Manderson, Elizabeth Cartwright and Anita Hardon

Routledge, 2016, 393 pages.

 

This is not a run-of-the-mill medical anthropology reader. Thank Routledge, its editors, and contributors for it. As someone who regularly convenes intermediate-advanced courses in medical anthropology, I’m grateful for its readability, teachable qualities, and particular theoretical angles. I’m going to trace four areas where I think the new Routledge Handbook of Medical Anthropology is innovative among the current offerings of similar edited volumes on the market for our discipline.

 

Visual innovation :: contextualized photographic figures

Recently, there’s been hot and necessary discussion about the images used for anthropology book covers: Tunstall and Esperanza (2016) over at Savage Minds provide interesting practical guidelines for book cover image selection as a way to decolonize anthropology. Ethnographies of medicine, suffering, and war with nuanced photographic figures of belabored people arguably make these books more compelling and help them win awards (De Leòn with Wells 2015, Biehl with Eskerod 2007, 2013), and also raise ethical questions about the images we choose to give life to our writing. The Routledge Handbook contains 16 photographic figures, taken by both contributors and others selected from a global Internet-based call-for-submissions in 2015, each placed as a ‘prelude’ (xii) to its respective chapter. A thoughtful, roughly 150-175 word description by the photographer accompanies each figure, giving it fuller context beyond the usual one sentence caption.

I appreciate projects that aim to decolonize higher education, the academy and our respective discipline, and find Tunstall and Esperanza’s approach insightful.

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.

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Coping with post-election stress disorder

We’ve often blamed the pharmaceutical industry for medicalising the normal ups and downs of life. But journalists are not above disease-mongering. I’ve just noticed a promising new ailment to which members of the Fourth Estte themselves are particularly susceptible: post-election stress disorder.  

According to columnist in Psychology Today, “Countless Americans are reporting feeling triggered, traumatized, on edge, anxious, sleepless, angry, hopeless, avoidant of connection, alone, and suddenly haunted by past traumas they believed they had buried” because of the Trump election.

As of now, no pharmaceutical company is marketing a drug to cure these anxieties. Instead, therapists are recommending a range of behavioural strategies for dealing with the stress. “I advise my clients and friends affected by the election and its aftermath to reach out, connect, affiliate and show compassion for those similarly affected,” wrote Steven Stosny in the Washington Post.

Some people are indignant that Post-Traumatic Stress Disorder after battle is being compared to discouragement after an election loss. Republican Congressman Brian Mast lost both legs in Iraq because of a roadside bomb. Let him have the last word:

There was a big missed opportunity in naming it ‘Post-Election Stress Disorder,’” he says. “I would have preferred they name it ‘Post-Inauguration Stress Disorder,’ that way they could have called it ‘PISD.’ There’s a big difference between being pissed off about things and what happens on the battlefield.”

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.

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He Vowed to Cure Cancer. But This Billionaire’s Moonshot Is Falling Far Short of the Hype

February 14, 2017

(STAT News) – But a STAT investigation of Soon-Shiong’s cancer moonshot has found very little scientific progress. At its core, the initiative appears to be an elaborate marketing tool for Soon-Shiong — a way to promote his pricey new cancer diagnostic tool at a time when he badly needs a business success, as his publicly-traded companies are losing tens of millions per quarter. STAT also found several instances of inflated claims, with the moonshot team taking credit for progress that doesn’t appear to be real. Soon-Shiong’s use of the moonshot to advance his business interests may be good for his investors. But it also increasingly looks destined to disappoint patients — the latest in a long trail of failed quests to win the war on 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.