Ask the patients about the benefits and the risks

January 16, 2019

Pär SegerdahlAlmost no medications are without risks of side effects. When new drugs are approved, decision makers must balance risks and benefits. To make the balancing, they use results from clinical trials where the drugs are tested on patients to determine (among other things) efficacy and side effects.

But how do you balance risks and benefits? Is the balancing completely objective, so that all that is needed is results from clinical trials? Or can risks and benefits be valued differently?

It has been noted that decision makers can value risks and benefits differently from patients. Therefore, results merely from clinical trials do not suffice. Decision makers also need to understand how the patients themselves value the risks and the benefits associated with treatments of their disease. The patients need to be asked about their preferences.

Karin Schölin Bywall is a PhD student at CRB. She plans to carry out preference studies with patients suffering from rheumatoid arthritis. The task is complex, since risks and benefits are multidimensional. Rheumatoid arthritis is a chronic disease with several symptoms, such as pain, stiffness, fatigue, fever, weakness, deformity, malaise, weight loss and depression. Medications can be variously effective on different symptoms, while they can have a range of side effects. Which positive effect on which symptom is sufficiently important for the patients to outweigh a certain level of one of the side effects?

Many patients naturally want the drug to enable them to work, despite the disease. However, if the pain is relieved enough to enable carrying out the work, while the medicine has as a side effect such fatigue that the patient cannot get out of bed, then the desired benefit is not provided.

To prepare her preference study, Karin Schölin Bywall decided to approach the patient group immediately. From the very beginning, she wanted to engage the patients in her research, by interviewing them about how they perceive participating in preference studies on new drugs against rheumatoid arthritis.

The patients stated that they saw it as important to be involved in regulatory decisions about new treatments of their disease. So that decision makers understand the patients’ own experiences of the benefits and risks that such drugs may have, and what the benefits and risks mean in practice, in the daily life of a rheumatic.

Results from the interviews are reported in the journal, The Patient – Patient-Centered Outcomes Research. The article emphasizes that preference studies can lead to drugs that the patient group is more motivated to take according to the physician’s instructions, which can improve clinical outcomes in the patients. The patients further stated that as participants in preference studies they want good information about how the drug functions, about how the study will be used by decision makers, and about where in the decision-making process the study will be used.

Feedback from patients is likely to become increasingly important in future decisions on medical products.

Pär Segerdahl

Schölin Bywall, K.; Veldwijk, J.; Hansson, M. G.; Kihlbom, U. “Patient Perspectives on the Value of Patient Preference Information in Regulatory Decision Making: A Qualitative Study in Swedish Patients with Rheumatoid Arthritis.” The Patient – Patient-Centered Outcomes Research, 2018. DOI: 10.1007/s40271-018-0344-2

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The human being is not only a category

January 9, 2019

Pär SegerdahlWe often use words as categories, as names of classes of things or individuals in the world. Humans and animals. Englishmen and Germans. Capitalists and Communists. Christians and Muslims. I want to highlight a difficulty we may encounter if we try to handle the problem of human violence from such an outward looking perspective.

Something that easily happens is that we start looking for the ideal subcategory of humans, whom we cannot accuse of any violence. If we only found a truly peaceful group of humans, somewhere in the world, we could generalize it to all humanity. We could create an evidence-based humanity, finally living peacefully. We could wipe out the problem of violence! However, where do we find the nonviolent humans who, on scientific grounds, could guide the rest of humanity to peace?

One problem here is that if we find some peaceful humans, perhaps on the British Isles, or in the Himalayas, then we must convert all other humans on the surface of this planet to the peaceful category. That does not sound promising! On the contrary, it sounds like a recipe for war.

Already the search for evidence seems violent, since it will repeat not just one, but all accusations of violence that ever were directed at groups of people. After all, there are:

  • violent Christians
  • violent Muslims
  • violent Capitalists
  • violent Anti-Capitalists
  • violent Germans
  • violent Englishmen

Moreover, there are violent trombonists. We also know that there are violent democrats, as well as violent anti-democrats. Lately we have been surprised to learn that even Buddhists can persecute humans and burn down temples and mosques. How about that! Even Buddhists are violent. The project to create an evidence-based, peaceful humanity seems hopeless.

However, let us turn this around. After all, we are all humans:

  • Christians are humans
  • Muslims are humans
  • Capitalists are humans
  • Anti-Capitalists are humans
  • Germans are humans
  • Englishmen are humans

Trombonists are humans, as are democrats, anti-democrats and Buddhists. We are all humans. Does it not sound hopeful when we acknowledge the fact that we are all humans? It certainly does sound full of promise. But why?

Is it perhaps because we stop opposing humans and instead speak more grandiosely about the human as one big universal category? I do not think so. After all, the problem was, from the beginning, that there are:

  • violent humans

It is not difficult to distrust the human as a universal category. Would it not be best if the human simply disappeared from this overburdened planet? Is it not horrible that we are all these humans, intruding on nature? In fact, there are those who propose that we should transgress the human category and become post-human. As though the solution were an unborn category.

No, the hope we felt emerged, I think, precisely because we stopped talking about human beings as a category. Notice the word we humans. What does it mean to talk about us humans? I think it means that we no longer speak of the human as a category in the world, not even grandiosely as a universal category. Rather, the human is, more intimately, “all of us,” “you and me,” “each one of us.”

When we talk about the human from within, we do not accuse the human as a worldly category to be violent. Rather, we see the violence in ourselves. I see it in me; you see it in you. We see the violence in each one of us; we see it in all of us. The responsibility thereby naturally becomes our own human responsibility. That is where the hope we felt emanated, I believe. It came from the internal perspective on the human. This nearness to ourselves made acknowledging that we are all humans sound full of promise.

I stop here. I just wanted to remind you of the fact that the human being is not only a worldly category with which to calculate and experiment. The category of the human can make us blind to ourselves as intimately alive, and thereby to the violence in us and to our responsibility for it.

I just hope this reminder did not trigger further violence: “What!? Are you suggesting that the problem lies in me? How impudent! Please, don’t include me in your pathetic we.”

Pär Segerdahl

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Dangers of moral words

December 11, 2018

Pär SegerdahlThe philosopher Bernard Williams distinguished between thick ethical concepts such as “brave” and “brutal,” which have both descriptive and evaluative content, and thin ethical concepts such as “right” and “wrong,” which are purely evaluative. “Murder” and “exploitation” are thick ethical concepts that sometimes play a central role in ethical debate. They have descriptive content combined with a negative evaluation: murder and exploitation are wrong.

This duality of thick moral words, their descriptive/normative Janus face, makes them an impelling part of the vocabulary of most, if not all, ideological movements. If you oppose X, and can demonstrate that X, in fact, involves murder or exploitation (descriptive aspect), then you have immediately demonstrated that X must be opposed (normative aspect). Thick ethical concepts are often used in conflictual situations to legitimize violent actions against people who are described as intriguing, murderous, exploitive, and much else. Since the words are taken to describe reality as it is, such bad individuals must be watched over and, if necessary, acted against.

Thick moral words thus easily lend themselves to functioning as ideological firearms. Their descriptive aspect allows taking aim. Their evaluative aspect says, “Fire!” I want to mention three further dangers of thick ethical concepts.

Dogmatism. The first is that it is difficult to raise questions about their applicability, since it can appear as if you questioned the evaluative component. Let us say that you raise the question if embryo destruction really constitutes murder. In the eyes of those who take this description for reality, you appear like a treacherous person who shrewdly argues that murder might be right! Simply raising the question, no matter how open-mindedly you do it, places you in the firing line. Your very open-mindedness speaks against you: “Murder is not something to be open-minded about!”

Righteousness. A second troublesome feature is that thick ethical concepts produce instant goodness in any ideological movement. Any ideology is on the right side, regardless of which side it is on, since it fights for what its moral vocabulary unites with the good, and fights against what its vocabulary unites with the bad. Any ideology has the right and the duty to act resolutely against what its dualistic vocabulary picks out as impermissible features of reality. – Which side for peace are you on?

Suffering. A third problem is that thick moral words produce suffering in the form of gnawing suspicions and fears. Since we are not omniscient, there is much we do not know, for example, about embryonic stem cell research. Thick ethical concepts here tend to appear in our heads as stand-ins for reality. They appear in the form of an inner voice that tells us what stem cell research is. This is not a purely descriptive “is,” but a double-edged one, for what the voice in the head says the research is can be a nightmarish, “It is murder.” Since we are ignorant of much, but not of our anxiety, we cannot shake off the worrying double-edged concepts that spin in the head. They seem validated by the gnawing anxiety they produce, and we suffer without end, caught in a whirlpool of thick descriptive/normative moral language.

In pointing out dangers of thick moral words, I am not questioning their descriptive or evaluative content. Murder is a reality and it is a serious crime; the same is true of exploitation. I am just pointing out that the dual nature of thick moral words can turn our heads. Moral language can make us violent, dogmatic, righteous, and anxious about issues that perhaps exist mainly in our descriptions of reality.

I think most of us have fallen into such dark pits.

Pär Segerdahl

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Drug addiction as a mental and social disorder

December 4, 2018

Michele FariscoCan the brain sciences help us to better understand and handle urgent social problems like drug addiction? Can they even help us understand how social disorder creates disorderly, addicted brains?

If, as seems to be the case, addiction has a strong cerebral base, then it follows that knowing the brain is the key to finding effective treatments for addiction. Yet, what aspects of the brain should be particularly investigated? In a recent article, co-authored with the philosopher Kathinka Evers and the neuroscientist Jean-Pierre Changeux, I suggest that we need to focus on both aware and unaware processes in the brain, trying to figure out how these are affected by environmental influences, and how they eventually affect individual behavior.

There is no doubt that drug addiction is one of the most urgent emergencies in contemporary society. Think, for instance, of the opioid crisis in the US. It has become a kind of social plague, affecting millions of people. How was that possible? What are the causes of such a disaster? Of course, several factors contributed to the present crisis. We suggest, however, that certain external factors influenced brain processes on an unaware level, inviting addictive behavior.

To give an example, one of the causes of the opioid crisis seems to be the false assumption that opioid drugs do not cause addiction. Taking this view of opioid drugs was an unfortunate choice, we argue, likely favored by the financial interests of pharmaceutical companies. It affected not only physicians’ aware opinions, but also their unaware views on opioid drugs, and eventually their inclination to prescribe them. But that is not all. Since there is a general disposition to trust medical doctors’ opinions and choices, the original false assumption that opioid drugs do not cause addiction spread and affected also public opinion, especially at the unaware level. In other words, we think that there is a social responsibility for the increase in drug addiction, if not in ethical terms, at least in terms of public policies.

This is just an example of how external factors contribute to a personal disposition to use potentially addictive drugs. Of course, the factors involved in creating addiction are multifarious and not limited to false views about the risk of addiction associated with certain drugs.

More generally, we argue that in addition to the internal bases of addiction in the central nervous system, socio-economic status modulates, through unaware processing, what can be described as a person’s subjective “global well-being,” raising in some individuals the need for additional rewards in the brain. In the light of the impact of external factors, we argue that some people are particularly vulnerable to the pressures of the political and socio-economical capitalistic system, and that this stressful condition, which has both aware and unaware components, is one of the main causes of addiction. For this reason, we conclude that addiction is not only a medical and mental disorder, but also a social disorder.

Michele Farisco

Farisco M, Evers K and Changeux J-P (2018) Drug Addiction: From Neuroscience to Ethics. Front. Psychiatry 9:595. doi: 10.3389/fpsyt.2018.00595

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Dissertation on the decision not to resuscitate

November 26, 2018

Pär SegerdahlSince the beginning of this blog, I have had the opportunity to write about Mona Pettersson’s research, which deals with decisions in cancer care not to resuscitate terminally ill patients through cardiopulmonary resuscitation. The physician makes the decision, if the patient has a too bad prognosis and is too weak to survive the treatment with good quality of life. Or if the patient has expressed a desire to not receive the treatment.

The latest post I published is from August this year: Ethical competence for the decision not to resuscitate. Since then, Mona Pettersson has not only published another article, but also defended her dissertation. In four sub-studies, she examines nurses and physicians’ experiences of the decision not to resuscitate. Among other things, she investigates their understanding of ethical competence as it relates to the decision, as well as what aspects of the decision they consider most important.

If you want to read the entire work, download the dissertation. You can also read more about Mona Pettersson in this Profile.

Pär Segerdahl

Pettersson, M. 2018. COMPETENCE AND COMMUNICATION. Do Not Resuscitate Decisions in Cancer Care. Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine 1499. 62 pp. Uppsala: Acta Universitatis Upsaliensis. ISBN 978-91-513-0459-5.

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Contemplative conversations

November 19, 2018

Pär SegerdahlWhen we face new sensitive and worrying issues, there is an instinctive reaction: this must be debated! But is debate always the right way, if we want to take human concerns seriously?

That some are worried about new research and technology, is a fact. That others are not worried, is also a fact. Suppose these people handle their differences by debating with each other. What happens?

What happens is that they leave the actual world, which varies as much as people are different, and end up in a universal world of rational reasons. Those who worry must argue for their concerns: All sensible people should feel worried! Those who are not worried must provide weighty counter-arguments: No sensible person should feel worried!

Debate thus creates an either/or conflict from what was only a difference. Polarization increases the fear, which amplifies the desire to be absolutely right. Everyone wants to own the uniquely compelling reason that everyone should obey. But since we are different, the debate becomes a vertiginous hall of mirrors. It multiplies exaggerated world images in which we lose ourselves and each other.

The worry itself, as trembling human fact, is forgotten. The only thing that engages us is the weighty reason for, or against, being worried. The only thing that interests us is what everyone should feel. Is that taking human concerns seriously? Is it taking ourselves seriously?

If a child is worried, we do not ask the child to argue for its worries, and we do not comfort the child by refuting it. We take care of the child; we take care of its worries, as compassionate parents.

I play with the idea that we and our societies would be in better shape if we more often avoided the absolute world of reasons. Through its universality, it appears, of course, like a utopia of peace and unity among rational beings. In fact, it often creates polarization and perplexes us with its exaggerated images of the world. Arguing for the right cause in debate is perhaps not always as noble as we take it to be.

We are, more often than we think, like children. That is, we are human. Therefore, we need, more often than we think, to take care of ourselves. As compassionate parents. That is another instinct, which could characterize conversations about sensitive issues.

We need to take care of ourselves. But how? What is the alternative to debate? For want of better words: contemplative conversations. Or, if you want: considerate conversations. Rather than polarizing, such an open spirit welcomes us all, with our actual differences.

Perhaps that is how we become adults with regard to the task of living well with each other. By tenderly taking care of ourselves as children.

Pär Segerdahl

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International brain initiatives need cultural awareness

November 12, 2018

Pär SegerdahlToday, billions of research dollars are being invested in developing huge research collaborations about the human brain. Australia, Canada, Japan, Korea and the United States have their own brain initiatives. In Europe, the Human Brain Project has a total budget of around one billion euros over a ten-year period, 2013-2023.

Scientific research is often seen as an activity that transcends cultural differences. However, research about the brain touches such fundamental aspects of human existence that it cannot ignore cultural views. For example, the notion that the brain, as a separate organ, is the locus of human identity, of the self, is not generally embraced. Neuroscientific research touches profound cultural ideas about human life which require careful philosophical and ethical attention.

The international brain initiatives also touch other culturally sensitive issues, in addition to questions about human identity. Ideas about death and brain death, about the use of nonhuman primates in research, about privacy and autonomy, and about mental illness, differ across cultures. For example, a diagnosis that in one culture can be seen as an opportunity to get individual treatment can in another culture threaten to condemn a whole family to social isolation.

Neuroethicists from parts of the world that currently make major investments in neuroscientific research met in Korea to highlight ethical questions on cultural differences, which the international brain initiatives need to address. This in order for the research to be conducted responsibly, with awareness of relevant cultural diversity. The questions that the neuroethicists (among them, Arleen Salles) propose should be addressed are summarized in an article in the journal Neuron.

The authors mention questions about how neuroscientific research could cause stigma in individuals or social groups, and about how cultural notions might bias research design and the interpretation of results. They ask how collecting and storing neural tissue can be viewed in different cultures, and about how we should understand the moral status of robots and computer-simulated brains. They mention questions about how new brain interventions (brain devices and drugs) may affect notions of responsibility and autonomy, as well as issues about drawing boundaries between legitimate and illegitimate uses of neuroscientific techniques. Finally, questions are highlighted about fair access to research results.

How can these questions be addressed and discussed in the international brain initiatives? The authors propose education in neuroethics, as well as dialogue with scholars in the humanities and social sciences, and finally improved communication and interaction with the publics.

Within the European Human Brain Project, four percent of the budget is used for ethics and society. Similar emphasis on ethical reflection would be desirable also in other brain initiatives.

Pär Segerdahl

Global Neuroethics Summit Delegates. 2018. Neuroethics questions to guide ethical research in the international brain initiatives. Neuron 100, October 10, 2018.  https://doi.org/10.1016/j.neuron.2018.09.021

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