A blog from the Centre for Research Ethics & Bioethics (CRB)

Month: April 2021

When established treatments do not help

What should the healthcare team do when established treatments do not help the patient? Should one be allowed to test a so-called non-validated treatment on the patient, where efficacy and side effects have not yet been determined scientifically?

Gert Helgesson comments on this problem in Theoretical Medicine and Bioethics. His comment concerns suggestions from authors who in the same journal propose a specific restrictive policy. They argue that if you want to test a non-validated treatment, you should from the beginning plan this as a research project where the treatment is tested on several subjects. Only in this way do you get data that can form the basis for scientific conclusions about the treatment. Above all, the test will undergo ethical review, where the risks to the patient and the reasons for trying the treatment are carefully assessed.

Of course, it is important to be restrictive. At the same time, there are disadvantages with the specific proposal above. If the patient has a rare disease, for example, it can be difficult to gather enough patients to draw scientific conclusions from. Here it may be more reasonable to allow case reports and open storage of data, rather than requiring ethically approved clinical trials. Another problem is that clinical trials take place under conditions that differ from those of patient care. If the purpose is to treat an individual patient because established treatments do not work, then it becomes strange if the patient is included in a randomized study where the patient may end up in the control group which receives the standard treatment. A third problem is when the need for treatment is urgent and there is no time to approach an ethical review board and await their response. Moreover, is it reasonable that research ethical review boards make treatment decisions about individual patients?

Gert Helgesson is well aware of the complexity of the problem and the importance of being careful. Patients must not be used as if they were guinea pigs for clinicians who want to make quick, prestigious discoveries without undergoing proper research ethical review. At the same time, one can do a lot of good for patients by identifying new effective treatments when established treatments do not work. But who should make the decision to test a non-validated treatment if it is unreasonable to leave the decision to a research ethical board?

Gert Helgesson suggests that such decisions on non-validated treatments can reasonably be made by the head of the clinic, and that a procedure for such decisions at the clinic level should exist. For example, an advisory hospital board can be appointed, which supports discussions and decisions at the clinic level about new treatments. The fact that a treatment is non-validated does not mean that there are no empirical and theoretical reasons to believe that it might work. Making a careful assessment of these reasons is an important task in these discussions and decisions.

I hope I have done justice to Gert Helgesson’s balanced discussion of a complex question: What is a reasonable framework for new non-validated treatments? In some last-resort cases where the need for care is urgent, for example, or the disease is rare, decisions about non-validated treatments should be clinical rather than research ethical, concludes Gert Helgesson. The patient must, of course, consent and a careful assessment must be made of the available knowledge about the treatment.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Helgesson, G. What is a reasonable framework for new non-validated treatments?. Theor Med Bioeth 41, 239–245 (2020). https://doi.org/10.1007/s11017-020-09537-6

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An unusually big question

Sometimes the intellectual claims on science are so big that they risk obscuring the actual research. This seems to happen not least when the claims are associated with some great prestigious question, such as the origin of life or the nature of consciousness. By emphasizing the big question, one often wants to show that modern science is better suited than older human traditions to answer the riddles of life. Better than philosophy, for example.

I think of this when I read a short article about such a riddle: “What is consciousness? Scientists are beginning to unravel a mystery that has long vexed philosophers.” The article by Christof Koch gives the impression that it is only a matter of time before science determines not only where in the brain consciousness arises (one already seems have a suspect), but also the specific neural mechanisms that give rise to – everything you have ever experienced. At least if one is to believe one of the fundamental theories about the matter.

Reading about the discoveries behind the identification of where in the brain consciousness arises is as exciting as reading a whodunit. It is obvious that important research is being done here on the effects that loss or stimulation of different parts of the brain can have on people’s experiences, mental abilities and personalities. The description of a new technology and mathematical algorithm for determining whether patients are conscious or not is also exciting and indicates that research is making fascinating progress, which can have important uses in healthcare. But when mathematical symbolism is used to suggest a possible fundamental explanation for everything you have ever experienced, the article becomes as difficult to understand as the most obscure philosophical text from times gone by.

Since even representatives of science sometimes make philosophical claims, namely, when they want to answer prestigious riddles, it is perhaps wiser to be open to philosophy than to compete with it. Philosophy is not just about speculating about big questions. Philosophy is also about humbly clarifying the questions, which otherwise tend to grow beyond all reasonable limits. Such openness to philosophy flourishes in the Human Brain Project, where some of my philosophical colleagues at CRB collaborate with neuroscientists to conceptually clarify questions about consciousness and the brain.

Something I myself wondered about when reading the scientifically exciting but at the same time philosophically ambitious article, is the idea that consciousness is everything we experience: “It is the tune stuck in your head, the sweetness of chocolate mousse, the throbbing pain of a toothache, the fierce love for your child and the bitter knowledge that eventually all feelings will end.” What does it mean to take such an all-encompassing claim seriously? What is not consciousness? If everything we can experience is consciousness, from the taste of chocolate mousse to the sight of the stars in the sky and our human bodies with their various organs, where is the objective reality to which science wants to relate consciousness? Is it in consciousness?

If consciousness is our inevitable vantage point, if everything we experience as real is consciousness, it becomes unclear how we can treat consciousness as an objective phenomenon in the world along with the body and other objects. Of course, I am not talking here about actual scientific research about the brain and consciousness, but about the limitless intellectual claim that scientists sooner or later will discover the neural mechanisms that give rise to everything we can ever experience.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Christof Koch, What Is Consciousness? Scientists are beginning to unravel a mystery that has long vexed philosophers, Nature 557, S8-S12 (2018) https://doi.org/10.1038/d41586-018-05097-x

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We transgress disciplinary borders

Fact resistance and human dissatisfaction with reality

What exactly is fact resistance? It is often defined as a tendency not to be influenced by facts that contradict our own beliefs. Or as a tendency to hold beliefs even though there is no evidence for them. To make fact resistance more humanly comprehensible, I would like to draw attention to a common way of expressing questions, which may remind us of how often we resist reality.

Have you noticed that many why-questions do not express any sincere wonder? We ask the questions to express our dissatisfaction with reality. Why does it always have to rain on Midsummer’s Eve? Why do I always have to choose the queue that takes the longest? Already in the question, reality is blamed. Already in the question, we resist reality. There must be something fundamentally wrong with the Swedish weather! I have to be an idiot who always chooses the wrong queue!

Fact resistance is probably a deeper human tendency than just a lack of criticism of one’s sources. It is an aspect of our human dissatisfaction with existence. Our why-questions rebel against the universe itself, if I may express myself dramatically. When we ask these questions, we do not expect any clear and reassuring answers, but rather answers that confirm the madness of the world. If I remember correctly, the pessimist Arthur Schopenhauer, who only saw misery everywhere, said that the world is so permeated by misery that only the world itself can be held responsible for the misery. The world must be fundamentally misconstrued. He described the misconstruction of the world in a great philosophical system, which was praised by pessimists around the world.

Imagine what happens when our why-questions are no longer about the midsummer weather or something equally trivial, but about phenomena that frighten and upset many at the same time. Like COVID-19 and pandemic measures. Many dubious claims will be spread as if they were certain, since already the questions are certain that something must be fundamentally wrong. I believe that fact resistance becomes more comprehensible if we see how humanly instinctively we rebel against reality.

Is not this common resistance pattern aroused even when we want to fight fact resistance? “Why do people spread so many obvious lies on social media? There must be something fundamentally wrong here, massive training efforts are needed!” Fact resistance is so close to us that even our concept of the pattern tends to get stuck in the pattern.

The amazing thing is that when we see the pattern in ourselves, fact resistance becomes more comprehensible as a fact and therefore easier to acknowledge without outbursts of upset why-questions. We see the pattern in a reconciling light. The fantastic thing, then, is that when we become forgiving, we no longer react against fact resistance. We are out of the game, free from our own fact resistance. Only then can we handle fact resistance wisely, without recreating it in our opposition to it.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

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We challenge habits of thought