Ethical Responsibilities of DTC Neuroscience Companies A - - PowerPoint PPT Presentation
Ethical Responsibilities of DTC Neuroscience Companies A presentation for the Presidential Commission for the Study of Bioethical Issues Margaret L. Eaton, Pharm.D., J.D. Salt Lake City November 5, 2014 Derivation of the Ethical
A presentation for the Presidential Commission for the Study of Bioethical Issues Margaret L. Eaton, Pharm.D., J.D. Salt Lake City November 5, 2014
Technologies that enable the monitoring and/or modulation of the function of the brain challenge existing notions of free will, identity, privacy, and mental health and well-being and pose additional social and ethical concerns when commercialized as products for both medical and nonmedical applications
MAXIMIZATION OF SHARHOLDER VALUE VS CORPORATE SOCIAL RESPONSIBILITY
Question: When the brain information/impact has human medical
significance, to what extent should companies heed/adopt/consider the ethical norms of the medical profession?
Patient centric Non-malfeasance Beneficence Respect for autonomy
Provide full information Refrain from coercion & exploitation
Confidentiality
Traditional Business priorities
Self then social
freedom to operate, pursue profits, open competition,
pragmatism, and efficiency
thereby serving financial interest of shareholders ultimately benefit society by producing useful products
Traditional Medicine priorities
Social then self
help the sick, advance medical knowledge freedom to practice financial gain
Consumers claim and have legal rights to reasonably
efficacious and safe products
Duty of the company to introduce to the market only those
products and services that have been validated and for which the safety and efficacy have been corroborated by scientific and medical consensus
avoid premature marketing identify how product upgrades or changes in medical
knowledge affect prior assessments and claims
notify prior consumers of these changes
Donald Kennedy: “I already don’t want my employer or my
insurance company to know my genome. As to my “brainome”, I don’t want anyone to know it for any purpose whatsoever. It is . . . my most intimate identity.”
Duty of companies to inform consumer and protect privacy
Explicit and easily accessible statements about the data
who owns it what does the company do with it who can gain access to it how is it protected can the consumer opt out of certain provisions of the policy and
still purchase the product?
Deficits are detected with no treatment options
consumers are at risk for developing depression,
anxiety and social problems related to their assumption that mental deficits are inevitable with no ability to prevent, control, or reverse
Duty of the company to ensure that knowledge
Companies that sell an assessment tool and a post-
assessment product or service
the frequency of diagnosis directly promotes growth in the
treatment or service arm of the business
Companies whose product usefulness is enhanced by the
size of its database
When competition for data becomes the driving force for
consumer recruitment, rather than product or service improvement, practices could become aggressive or coercive
Duty of the company to recognize the incentive to over-
promote and to curb self-serving practices
Ads that contain unsubstantiated claims constitute an insult to
consumer decision-making and autonomy
The knowledge disparity between the company & the consumer is
Ads “medicalize” normal conditions Appeals to enhance abilities raise distributive justice issues
high costs limit access ads are targeted to wealthier consumers who can afford the
product
Appeals to fear in vulnerable populations
Loss of mental control Your child will suffer
If the target population is susceptible (elderly, adolescents, parents
with low health literacy, etc) ads can exceed the legitimate goal of manipulating consumer behavior
There can be a fine line between persuasion and coercion
DTCA techniques to promote a perceived need for the drug
self diagnosis: mental illness self-assessment tests emotional appeals: fear, expectations of happiness, regret for
not using the product
normalize the illness to overcome reluctance to seek treatment success stories no mention of research showing lack of SSRI efficacy over
placebo
coaching scripts on how to ask your doctor for the drug
These ads are ubiquitous, are effective in increasing
prescribing, & contribute to over-prescribing
While neuroscientists debate the most basic of biological
mechanisms that may be involved in mental function and illness, ads for supplements confer scientific credibility to claims by referring to, e.g.,:
“enhances neurotransmitter precursors”, “boosts
mitochondrial activity”, protects against “free-radical attack.”
Dietary supplements are not required to
demonstrate safety and efficacy through clinical trials before distribution
Yet, claims such as this are made:
“designed to enhance the health of your brain for improved
brain function, increased focus, and better memory. With each serving, you’ll be able to reduce stress and increase the flow of blood to your brain for more clarity”
A “brain fitness tool that helps you do
more with your mind, and more with your life, in just 3 minutes a day” to “improve your focus, attention and composure”
No peer reviewed controlled studies have
demonstrated safety or efficacy of the device or the associated apps
CEO: “This is the first EEG device that's
really a consumer product, that's designed for ease of use, and comes with an app that's really meaningful.”
Companies that sell ethically and socially sensitive products seek
the advice of ethicists familiar with the biopharmaceutical industry
train personnel to avoid ethical pitfalls
e.g.,, the Bad Ad Program of Office of Prescription Drug Promotion
Industry groups for these companies adopt guidelines to address
the ethical aspects of their activities
validity and reliability, safety, privacy protections, evidence based
claims, responsible advertising
If the product has medical implications
consider adopting decision making frameworks and ethical norms
consider voluntarily following regulations and guidelines that
would apply if the company was subject to regulation