Scenarios as “Grounded Explorations”. Designing Tools for Discussing the Desirability of Emerging Technologies

Abstract

This chapter addresses the question of how the analysis of expectations’ plausibility, described in the previous chapters, contributes to the goal of fostering a democratic deliberation on the normative acceptability of emerging technologies (outlined in Chap. 1). Building on pragmatist ethics approaches, the normative ideal of democratic deliberations around science and technology is outlined as an attempt to include different perspectives in the deliberative process; articulate the reasons, meanings and assumptions behind a problem; and explore possible scenarios of how new technologies change our moral concepts and vocabularies. In this context, “moral imagination” is presented as a way of broadening democratic deliberation exercises to create spaces for discussions of “ideas of good” and moral values. After reviewing some types of scenarios that have been developed as tools for discussing the social and ethical issues of emerging technologies (namely, “socio-technical” scenarios and “techno-ethical” scenarios and vignettes), indicating some of their limitations, the chapter addresses the issue of using scenarios to trigger the moral imagination of technology developers. It does so by discussing two exercises based on the analysis of expectations’ plausibility conducted in the previous chapters of this book that have been designed in order to produce a “grounded” and “exploratory” discussion with the developers of the Nanopil and Immunosignatures.

[We] really are only able to, and need to, question our basic assumptions in the moment when we collide with an element of the complexity of our life, a tear in the routine of experience that requires us to rethink things in order that we might progress along our current (or any other alternate) course. (McGee 2002: 112)

Appendix: Techno-Ethical Scenarios and Techno-Moral Vignettes

1.1 Techno-Ethical Scenarios on Immunosignatures

1.1.1 Scenario 1 Part 1

1.1.1.1 Current Situation

Partly due to science and technology advancement, we are currently experiencing an increase in the longevity of the American population. This larger demographic of elderly persons, implies an increase in the amount of sick people, since are more prone to get sick or diseased. These costs are not sustainable in the long run.

A conspicuous number of experts from diverse fields points out that in order to address this problem, the adopted healthcare model has to move away from a symptomatic “one size fits all” treatment-based approach. A more affordable and effective model should lead towards (1) personalized and targeted care, (2) early and individualized diagnostics and (3) preventive risk predisposition.

These trends are visible in a broader landscape of actors operating within the sector of innovation in the American healthcare. To point out a few examples, hospitals promote innovative wellness programs in which patients are motivated to change their lifestyle; FDA encourages pharmaceutical companies to develop companion diagnostics; national and local policies of health educations raise citizens’ awareness with prevention information campaigns.

The Biodesign Institute at Arizona State University is active in supporting science and technology contributing to this broader purpose. Immunosignature research, at the Centre for Innovations in Medicine, aims at developing a tool for early, pre-symptomatic and personalized detection of diseases. This preventive healthcare model promotes a “patient-centered” approach.

In a patient-centered vision of healthcare, people do not need doctors and are able to be in control of their health in an autonomous way. In the long term, this vision implies that people commit to a healthier lifestyle and are responsible for their health without the mediation of a doctor. Some online platforms like patientslikeme.com, curetogether.com, inspire.com are already heading in this direction: they create social networks in which patients can compare their data and support each other. The concept behind Immunosignaturing (IMS) is to contribute to this aim. It enables individuals to become more aware of their health and invites them to perform daily monitoring. With Immunosignaturing, as Dr Stephen Johnston explains, “each individual could see their own biosignatures and the implications of these signatures on a regular basis. This should empower them to take more responsibility for their own health and stimulate their own scientific education on what this means”.

1.1.1.2 2012–2017

CIM directors decide to pursue the patient-centered vision and they contact different online platforms in which patients interact. In January 2013, the R&D director of the for-profit organization “patientslikeme.com”, which provides a platform for patients to exchange information and “converts their stories in computable data”, contacts the directors of the Centre for Innovation in Medicine. He has read about Immunosignaturing from their website (in which CIM recruits people who want to donate biological samples and share their health information to contribute to the IMS research). The two agree to sponsor the IMS project on the “patientslikeme” website in return for free immunosignatures for their users. In a video interview published on patientslikeme.com, CIM co-director Neal Woodbury explains the difference between IMS and genetic testing: “Genetic tests tell you about your genetic make-up, that you share with your family. Immunosignatures tell you a story that is unique to you. This is the story of the places you have visited, the food you have been eating, the things you have been doing. Your immune system stores all this information as a big book and by reading its pages day after day you can understand the implications of your daily choices on your health”. A disclaimer on the website explains that IMS is still a developing technology and the data and its interpretation is still uncertain. After few months of collaboration, JameX, a diabetic user on “patientslikeme”, compares his IMS with that of JulieD and comments on the blog about the surprising similarities between their condition and the IMS picture “These images are helpful beyond words… I feel connected to people who are suffering from the same symptoms as myself. And we know we can do something to change them. You have made me feel empowered…”. Some smokers start an online support group on patientslike.me in which they motivate each other to quit smoking.

In September 2014, the behavioral psychologist Dr Shannon Kyle comments on the phenomenon of health social networks in Time magazine, “the IMS images are constantly changing and when patients see this they feel that they can control their health. Therefore they are motivated to change their smoking habits. The fact that they can openly share this information with other users commits them to a healthier behavior. Solidarity and community values play an important role in this”. In February 2015 Google Health offers to have IMS has an available test on their website. Health Tell company, owned by Stephan Johnston and Neal Woodbury, starts doing IMS.

In December 2015, the Office of Privacy and Civil Liberties comments on the flow of sensitive data that endangers privacy. “Furthermore, information like that provided by IMS is not really robust. They show a picture with different colors that changes day after day, but what this means with respect to people’s health is still unclear. Researchers are still working on this and the whole point of this website is to have free samples. It’s just a business at the expenses of users, who should be protected”. Some voices are raised by the community of patientslikeme.com against these accusations “People have the right to know about themselves, and IMS enables them to do so” “the whole idea of patientslikeme.com is to create a community in which people share stories and learn from each others, transforming their individual stories into a learning experience for others like them. IMS simply works in making people aware of the consequences of their lifestyle. Even if the meaning of the information is not clear yet, it does something good for people. And this is what matters”.

In April 2016, Sally Meine, a 19 year old girl from Ohio, is admitted to the Cleveland Clinic in a coma, and is diagnosed with extreme malnutrition. When she regains consciousness, she explains to the doctors that she was experimenting with her friends to see how her immunosignature would change if she ate only fruit. The parents of Sally sue patientslike.me and Health Tell for liability for not putting in place enough failsafe to prevent misuse of IMS technology. In May, Sally’s case is brought up in FDA discussions about the large availability to a broader public of sensitive medical data that is still not reliable.

In December 2016, the CEO of a famous pharmaceutical company criticizes the FDA intervention. In an editorial, he highlights that collaboration between HealthTell and patientslikeme.com are promising because they enable profiling of a large number of people with high degree of statistical relevance, advancing risk assessment and steering the direction of company research: “these experiments are nothing new, they happen everyday with Google. Why shouldn’t we use the same tools to develop our knowledge of health conditions and ultimately make our healthcare system more effective?”

The FDA’s objection on the disclosing of Immunosignatures to patients on online platforms is legally reinforced due to the “current lack of reliability” of the information provided. However, an increasing consensus in industry and political environment acknowledges the importance that research on personalized signatures could have for national healthcare. Following a political controversy on the desirability and feasibility, in November 2017, policy agreements are made:patients’ medical histories and biological samples analysis will be stored online. This information is openly available to researchers, while maintaining patient anonymity. Educational campaigns are promoted to encourage people to contribute to this database: “Do it for your future. Do it for your children. Do it for a world without patients”.

1.1.2 Scenario 1 Part 2

1.1.2.1 2018–2024

This decision boosts the development of IMS analysis. In 2020, a normalized “healthy” signature is established (including an algorithm to account for individual variation), leading to an improved detection and determination of illness. In 2022, local governments start some wellness programs, educating citizens to adopt a healthier behavior. IMS is proposed as a good tool for educating healthy citizens to take more responsibility for their health.

In January 2023, in the state of California programs are initiated to provide people with lower incomes access to IMS at home. This is undertaken as an experiment to see if they engage in a healthier lifestyle. To make it more compelling, people are offered public Medicare in exchange for monitoring themselves with IMS on a weekly basis. Eligible citizens have to pick up the test at the closest Urgent Care clinic and send a biological sample to be tested with IMS. They receive the results via email and they can check their medical record online. They are told if they should inform the Urgent Care in case of serious and continuous abnormal signature.

In August 2026, the case of Francis Caine raises the public interest. In June 2024, Francis had received a message that she had to go to the urgent care clinic, but she had failed to do so. After 1 year she was diagnosed with cancer. The hospital had contacted the governmental Medicaid and they discovered that she was in the program but she had never acted on it. After the surgery, she is required to pay, because she didn’t contact the urgent care immediately. In an interview Francis explains: “I didn’t have any symptom back then, I felt good, I just did not think that it could be serious”. Her neighbor comments, “She was already lucky not to pay for the medical insurance, but she did not care that the government and other citizens are paying for her. She was given the chance of being proactive, but she decided not to…now she has to pay”. However, patient advocates take the side of Francis: “Discovering that something is wrong with you, that you might have a disease, that your life is threatened is overwhelming. We cannot expect that a single individual can cope with this information alone and simply act as others have told her to act. With this IMS idea, institutions are unloading their responsibility onto the patients rather than providing them with guidance and care”.

1.1.3 Scenario 2 Part 1

1.1.3.1 Current Situation

Partly due to science and technology advancement, we are currently experiencing an increase in the longevity of the American population. This larger demographic of elderly persons implies an increase in healthcare costs, since the elderly are more prone to sickness or diseased. These costs are not sustainable in the long run.

A conspicuous number of experts from diverse fields points out that in order to address this problem, the adopted healthcare model has to move away from a symptomatic “one size fits all” treatment-based approach. A more affordable and effective model should lead towards (1) personalized and targeted care, (2) early and individualized diagnostics and (3) preventive risk predisposition.

The Biodesign Institute at Arizona State University is active in supporting science and technology contributing to this broader purpose. Immunosignature research, at the Centre for Innovations in Medicine, aims at developing a tool for early, pre-symptomatic detection of diseases. This preventive healthcare model promotes a personalized diagnostics: “you are compared with yourself yesterday”. This long-term vision of pre-symptomatic and personalized diagnostics is expected to go through an earlier phase of personalized (symptomatic) early diagnostics. The application of IMS in a clinical context presupposes a system in which doctors play a central role and in which technology is expected to offer a tool for them to improve their practice. In this sense, IMS is considered as a tool to improve the current diagnostic practice.

Ongoing research at CIM focuses on screening and diagnostics for chronic diseases (i.e. Alzheimer), monitoring for cancer recurrence, and diagnostics for infectious diseases like Valley Fever. The potential diagnostic tools arising from this research are expected to be used in a clinical context.

Half of those affected by Valley Fever in the U.S. are in Maricopa County. Two-thirds are in Arizona. Fungus in the soil, especially during the dry, windy season, becomes airborne and settles in the lungs to cause the disease. In 2006 Tucson-based C-Path also helped UA scientists receive Orphan Drug Status from the U.S. Food and Drug Administration, which would allow scientists to apply for grants to help pay for the development of the drug.¹³

In 2011, coccidioidomycosis (Valley Fever) is reported by the Council of State and Territorial Epidemiologists (CSTE) as a nationally notifiable disease. This increases the publicity and mindshare in the public health community.

1.1.3.2 2012–2017

In June 2012, a study of the Centre for Disease Control highlights the healthcare costs of Valley Fever treatment for the State of California. In this study, the costs of absenteeism and presentism in the workplace due to Valley Fever are emphasized. At the end of 2012, Valley Fever Therapies LLC forms a partnership with the state of Arizona to take the drug to the market. “The state of Arizona thinks that this is an important enough public health issue” says Dr Galgiani, director of the University of Arizona Valley Fever Center for Excellence. Under these circumstances a diagnostics for Valley Fever becomes critical. Dr Galgiani and Dr Johnston, the CIM co-director and Health Tell CEO, investigate Clinical Laboratory Improvement Amendments (CLIA) certification for an immunosignature test.

In December 2013, the American Medical Association (AMA) includes the Immunosignature test for Valley Fever in Current Procedural Terminology in Category III.¹⁴ As a member of the board of trustees of the American Medical Association explains: “Primary care physicians in Arizona have been encouraged to enroll in educational programs about early diagnosis of Valley Fever. AMA considers this of utmost importance in the Valley area in order to improve patient care by reducing patient anxiety and unwarranted use of antibacterial agents. Moreover, serious complications requiring treatment might be identified sooner.”

In May 2014, the state of Arizona initiates a public campaign to raise people’s awareness of symptoms and potential treatments for Valley Fever. “My friend Karen died of complications from Valley Fever while she was pregnant. She was not diagnosed in time. This was at the beginning of 2000” explains Mia Valdivia, patient advocate for Valley Fever Survivors. “Since then, many things have changed. In this last year, I have received so many letters from people who go to primary care with few symptoms, are diagnosed with Valley Fever within one week, are quickly treated and keep on living normal lives”.

In December 2015, Mr Carl Carlson was admitted to the Mayo Clinic in Scottsdale with advanced lung cancer. “He was diagnosed with Valley Fever one year ago with one of those tests. The doctor prescribed him some drugs, but the symptoms never left. Now they say that for all this time the cancer was growing. I want to understand who is responsible for this case of malpractice, the laboratory or the doctor?” says his wife, interviewed by a local radio channel. “The fact is that these immunosignature tests are optimized on some statistical data, the physician should examine the patient carefully and provide a more personalized diagnostics” the PR of a diagnostic company explains.

Following up this case, the National Center for Ethics in Health Care (NCEHC) issues a report on the use of laboratory diagnostics in primary care practices and emphasizes the importance of traditional diagnostics. “Primary care medical clinics in Arizona are financially benefiting from the introduction of IMS diagnostics in the CPT. For each of these tests they get a service fee, but they do not take time to actually visiting the patient, ask about the symptoms, provide high quality care and information. But of course these tests are never 100 % reliable. They should spend more time looking at the personal history and situation of the individual patient”.

In April 2016, The association of American Physicians responds to this report explaining the worsening of their working conditions “primary care doctors earn much less than other specialists and have to work in more difficult conditions. We can afford just 20 min per patients. How do you think we can provide good quality care? Furthermore, the spread of new diagnostic tests and new procedure demand a lot of preparation and retraining. Often these tests do not give a yes/no answer, but a grey result that needs to be interpreted. This is the responsibility of the doctor. If we spend all of our time learning about the possibilities for personalized diagnostics, when can we actually provide more personal care?”.

In January 2017, the Centre for Medicare and Medicaid discusses the possibility of moving the Valley Fever diagnostic procedure to retail clinics (located inside retail/grocery stores) and staffed by non-physician providers, such as physician assistants and nurse practitioners, with remote physician supervision. This would release primary care doctors from the burden and decrease the service fees. However, due to its serious consequences the AMA points out that Valley Fever cannot be considered as a minor illness and should therefore be treated by physicians.

1.1.4 Scenario 2 Part 2

1.1.4.1 2017–2025

In 2017, there is a breakthrough in the collaboration between CIM and Mayo clinic: statistically relevant differences between immunosignatures of esophagus cancer patients and patients whose esophagus cancer has been eradicated are established. This enables researchers to optimize a test to monitor the recurrence of the cancer.

In 2020, the test receives CLIA certification, however the previous controversies rose with the valley Fever makes the AMA wary about inserting this test into the CPT lists. “This test opens the possibility for a cheap monitoring of cancer patients, but who should read these signatures? The oncologist or the GP? It is too delicate for GP, but the benefit of the test is to alleviate the work of oncologists.” The test does not take on with GP’s, but is taken up and appreciated by oncologists.

In 2023, Cleveland Clinic is interested in using the immunosignaturing test for cancer recurrence in their “health care at home” program. This program was initiated by the innovation department of the clinic as an attempt to respond, on one hand, to pressures of private insurance companies for reducing patients’ visits to the outpatient clinic, and on the other hand to the pressure for a more continuous and effective connection between the patients and the care provider. With this program of remote healthcare patients are connected to the clinic via online facilities on a daily basis and the costs of visits to the clinic are kept lower. IMS is introduced as a home test for cancer patients to monitor eventual recurrencies. Every three months patients are sent at home a kit from the hospital and asked to send a biological sample by mail.

The head of the innovation department of Cleveland Clinic explains that this program makes healthcare a continuous and daily process, rather than an episodic one, “We offer a better quality care”. “This is the future of healthcare, continuous monitoring of vitals and other values”. You don’t need to go to the hospital anymore. Payers are satisfied for the reduction of the costs.

However, George Carter, a 58 year old cancer patient, is found dead at home by a friend. In a letter he describes how he knew that is tumor was growing, but he was too afraid to go through the surgery again. He stopped collecting samples. “He was missing the personal relation with his doctor, when you don’t have a person on the other side who is taking care of you, what do you do? Do you really call it personal care? Where is the person here?”. The hospital responds that results of the test were returned to the patient with an advice to contact them, but were not actively followed up by the hospital. “We put the patient autonomy on the first line. It is our core value to respect the decision of our patient, whether they decide to go for a treatment or they decide to decline it.”

1.2 Techno-Moral Vignettes on Nanopil

1.2.1 Vignette 1

“I am not gonna do this again, it’s disgusting!”

“Listen, Nya, I’m tired of this. Try to behave like an adult, you are 22 now! You know why you have to drink this laxative.”

“Yes, for the stupid pill to work.....”

“This ‘stupid’ pill is an easy way to check that everything is fine. Your dad’s family has a history of Colorectal cancer so you had to start screening early. Consider yourself lucky, 20 years ago people had to collect a sample of their stool, smear it on a sample card, compile it with their information, seal it and mail it to the lab. The pill makes this much more simple, comfortable and clean!”

“SIMPLE, COMFORTABLE, and CLEAN???? Why don’t YOU try drinking this crap? And this unbearable nausea. Blech. I feel like I have to throw up after every sip. Having to run to the toilet every half an hour is clean? Joyce wanted to go to the cinema with me, but I can’t! I have to be at home, drinking laxative, feeling sick and running to the washroom every 10 minutes. I feel like I am spending the whole day in the bathroom. I would rather spend 1 minute collecting samples and forgetting about it. But instead, I have 2 more liters of laxative to go. ARGH…”

“Hun, you are behaving like your grandma! Just drink it, the doctor said…”

“I don’t care about the doctor, I am not gonna drink it all.”

“And if the pill isn’t going to work then?”

“Even better, then they will think that I am fine and they will leave me alone.”

1.2.2 Vignette 2

Policemen: “Your identification and car documents, please.”

Mr Watson: “Oh sure, I am really sorry, I am still in shock. The car is really damaged!”

Policemen: “Can you explain what happened?”

Mr Watson: “Yes, but I guess I have to explain it from the beginning. As every Wednesday, I take time off work to take care of the children. But today I was also supposed to screen for colorectal cancer. You know, I am over 50 and they sent me a test for checking if I have cancer. It is one of those pills that you swallow and it checks your intestine from inside and sends a report of the test to your mobile phone and to the doctor. Anyways, I was really eager to take this test, because lately I experienced some pain in the lower abdomen and I feared that there could be something wrong. The fact is, I was very nervous about the result of the test. So after swallowing the pill I waited and waited and I couldn’t accomplish much besides imagining the pill floating within my intestine. But the message hadn’t arrived yet, when it was time to leave home and pick up the children from school. So I went.”

Policemen: “Are you allowed to drive when you take this pill?”

Mr Watson: “Well, it is said that with the pill you can test your health everywhere and once you have the signal-receiving belt on and your mobile phone close to you, it’s just fine. However, while driving, I felt again a stinging pain in my abdomen, so when I felt the vibration of my mobile phone finally notifying me about my health status, I was distracted from observing the street. So I didn’t see that the car in front of me was so close. I am terribly sorry, but how can you focus on the street, when you are afraid that your health is at stake?”

1.2.3 Vignette 3

Doctor Jansen smiled while the next patient walked through his office’s door. This should be Mr Smit. He opened Mr Smit’s personal record on his computer and looked at it. Mr Smit was there because the result of colonoscopy was positive and a neoplasm had been found. Dr Jansen told Mr Smit about the advanced status of the cancer and the need for an immediate intervention.

“I don’t understand, doctor, 2 years ago I participated in the national screening program and I took a pill to check whether everything was fine…”

“Yes, actually, I can see it on your record, but there is no result associated, are you sure you did the test?”

“Yes, I am, I remember it quite vividly because I hated having to take this laxative! I don’t think I heard anything about the test afterwards, but I simply assumed that it meant I was OK. So how is it possible that this tumor is so big already? It must have been there two years ago! It would have been smaller then. What’s the point of a screening that doesn’t work?”

Doctor Jansen wondered, what had gone wrong two years ago? The pill, or the network? Maybe Mr Smit had done something wrong? Or maybe he himself had done something wrong. But with all those screening tests around, how to keep track?

“Mr Smit, please calm down, what did you do when you didn’t receive a message? Did you call here to know more? That would have helped in tracking the problem at the time.”

“Doctor, how could I have known? I took the test, nobody contacted me, so I thought I was fine, I thought I was under control. That’s what I think when I am in a screening program, when I perform such an innovative test, sent to me by this screening organization. I think that everything is under control.”

“I am sorry Mr Smit, but I must correct you. This screening program, like other do-it-yourself-prevention programs, presupposes that you are a responsible and autonomous person, who can take care of monitoring his own health condition. But this also means that you are expected to be more proactive. You have been negligent, Mr Smit.”