Commercialization, but not at any price

February 14, 2017

Pär SegerdahlIn a previous post, I tried to make the point that the pharmaceutical industry can support altruism between research participants and patients, despite the fact that the industry itself is not altruistic but is driven by profit. Medical research will not benefit patients, unless results are developed into commercially available treatments.

However, this presupposes, of course, that pricing is reasonable, so that we can actually afford the drugs. Otherwise, research and research participation become meaningless.

Today, I just want to recommend an article in the journal Cell, where the authors argue that the prices of new cancer drugs have become indefensibly high. They propose new collaborations between academic researchers and small companies, to offer cancer drugs at more reasonable prices. Researchers should ensure that the companies they work together with are willing to sell the drugs with smaller profit margins.

You can find a summary of these ideas in The Guardian.

Pär Segerdahl

Workman, P. Draetta, G. F., Schellens, J. H. M., Bernards, R. (2017). How much longer will we put up with $100,000 cancer drugs? Cell 168: 579-583.

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What is the risk?

November 2, 2016

Pär SegerdahlTo communicate about genetic risk with patients, we need to know how people think about risk and that experts and people in general often think differently.

A common feature, however, is this: Risk has to do with future adverse events. We talk about the risk of getting sick. But we rarely talk about the risk of getting well. We must then imagine people who value their disease (perhaps to avoid enrollment in an occupation army).

The expert’s concept of risk presupposes the negative value, but does not delve into it. It focuses on the probability that the unwanted event will happen (and how certain/uncertain the probability is).

For patients, however, the value aspect probably is more in focus. A couple learning about a 25% risk of having a child with a certain disability probably considers how bad such impairment would be: for the child and themselves. Maybe it isn’t so bad? Perhaps there is no great “risk” at all! They evaluate the risk scenario rather than calculate the probability.

How can we understand this value aspect, which risk presupposes and patients ponder? Ulrik Kihlbom at CRB asks the question in an article in the Journal of Risk Research.

Kihlbom describes two common ways of understanding value. The first is in terms of preferences. People have different preferences. Most prefer health before sickness, but occasionally someone may prefer disease. Value lies in satisfying these preferences, whatever they are. There is then only one value: preference satisfaction. The problem is that we can object that these preferences are not always reasonable or well informed. Additionally, patients can adapt to their illness and prefer their lives as much as healthy persons prefer their lives. Is it valuable to satisfy even such preferences?

Not surprisingly, the other way of understanding value is more objective. Here one assumes that value depends on how well certain basic human capabilities are supported. Such as being able to use one’s senses, imagine, think, play, be healthy, etc. Here there is a more objective measure of value. The problem is the authority the measure is given. May not a person lack some of these capabilities and still live a full and dignified life? Who decides which capabilities should belong to the measure?

Actually, I would say that both proposals impose a measure of value. Preference satisfaction is, of course, a general measure too.

Kihlbom proposes a third way of understanding value. No measure of value is imposed and value is not separated from that which has value. If someone gets cancer, the negative value lies already in the disease, so to speak. A person who knows what cancer is does not ask: “Why is it bad to get cancer?” And hardly anybody would answer: “Because it frustrates my preferences” or “Because it prevents me from flourishing as a human being.”

Knowing what disease is means knowing that it is bad. It is part of the point of the word. To exclaim, “I’m so sick!” is to complain (not to rejoice). The value lies in the phenomenon itself and in the word. If some people still value their disease (perhaps to avoid military service), the value lies in the situation where the disease can appear as a good thing.

This is probably how people approach genetic risk information: What does this mean in my life? How bad is it? They immerse themselves in the value aspect, which the numerical probability presupposes. The 25-percent risk of having a child with a certain disability leads to concerns over what such a life might turn out to be like; how it can be described; how it can be valued.

So what should we keep in mind in genetic risk communication? The novelty about genetic risk information is not only that patients get difficult to interpret percentages of probability. The scenarios are new. These scenarios can involve time perspectives that extend throughout one’s future life, even to future generations. They can be about diseases and treatments that we do not know what it means to live with.

We evaluate risks daily (like the risk of missing the train), but here patients encounter novel risk scenarios that are difficult to evaluate. If I understand Kihlbom right, he thinks that the challenge is not only to explain probabilities to patients. The challenge is not least that of talking with patients about these new risk scenarios: about how they react to them in terms of value, how they describe them as “catastrophic” or “not so bad.”

Patients need support to evaluate genetic risk scenarios reasonably; not only to understand probabilities.

Pär Segerdahl

Kihlbom, U. 2016. “Genetic Risk and Value.” Journal of Risk Research, DOI: 10.1080 / 13669877.2016.1200653

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How to listen to (the right) patient voices?

October 25, 2016

Ulrik Kihlbom, Academic co-lead of PREFER's methodology work packageWe all think patients’ voices are important. But how do we make sure we listen to the right ones? Patient engagement and patient perspectives have come into focus in health care in recent years. Though this is especially true for the clinical setting, this development can be expected to continue for decision-makers at other levels.

We are just starting to research these questions in a project called PREFER. The aim is to establish which methods to use to bring in patient perspectives into important decisions regarding medical drugs; decisions made by different stakeholders, such as physicians, regulatory and reimbursement authorities, and the industry. In short: how and when should decision makers listen to the patients?

But, how can we make sure that the methods enable decision-makers to listen to the right patient voices?

Now, the expression “the right patient voices” should plausibly be understood as comprising several aspects such as being representative of the actual views patients have, being adequately informed, and as being non-biased. Each of these aspects require thorough consideration and also methodological development. I am myself responsible for one task that will specifically address these questions. One of the many intriguing issues here is when, during the process of falling ill, coming under treatment, and hopefully convalescing, a patient’s voice should be listened to? The patient’s preferences will probably change during the trajectory of illness. Imagine that you fall seriously ill, are treated and recover, and suppose also that your preferences for a risky treatment change during this period of time. Do you know when your preferences are such that your physician should listen to them? And when they merit less attention? I am myself far from sure how to answer this question.

Another set of questions concerns how the (right) patient perspective should be incorporated into the decision making. How, for example should a reimbursement authority weigh the patient perspective against cost-effectiveness when making a decision of subsidising a medical drug? Or how should a regulatory authority, such as EMA in Europe, FDA in the US, and Läkemedelsverket in Sweden, weigh patient effectiveness against safety concerns? It seems fair to say that everybody agrees that the patient perspective should have a weight, but no one has an established scale.

These are some of the very hard and intriguing questions that the PREFER project will address over the coming five years. 33 partners from academic institutions, patient organisations, health technology assessment bodies, small companies and the pharmaceutical industry are putting their heads, competence and resources together. Uppsala University is coordinating the project, with CRB’s director Mats G. Hansson at the helm. Apart from me and Mats, Josepine Fernow, Elisabeth Furberg, Jorien Veldwijk and Karin Schölin Bywall at CRB are involved in PREFER. We are looking forward to interesting research questions, but also to learning by working in, and leading, a public-private partnership of this size.

In the autumn of 2021, the project will issue recommendations. By then we will know better how decision makers may find and listen to the (right) patient voices. And how patients’ voices can make themselves heard in the decisions of regulators, health technology assessment bodies, reimbursement agencies, and pharmaceutical companies.

Ulrik Kihlbom

About PREFER: The Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115966. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The contents of this text reflects the author’s view and not the view of IMI, the European Union or EFPIA.

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Physicians’ experiences of do-not-resuscitate orders

September 21, 2016

Pär SegerdahlCritically ill patients sometimes have such a poor prognosis that cardiopulmonary resuscitation for cardiac arrest (CPR) would not help. They are so weak that they would not survive the treatment. If they survive, they do so with even poorer quality of life. The physician can then write a so-called DNR decision, which means that CPR should not be performed.

Mona Pettersson, PhD student at CRB, writes her thesis on these decisions. I have previously written about her first study, in which she interviewed nurses about their experiences of DNR decisions at Swedish hematology and oncology departments.

This summer the Journal of Palliative Care and Medicine published the second study, in which physicians were interviewed about their experiences of these decisions.

In the interview material, Mona Pettersson discerns three roles that physicians perceive they have. They act as decision maker, as patient advocate and mediator for relatives, and as team member. Physicians describe their experiences of these roles, such as the importance of making clear to relatives that it is the physician who makes the decision – so that relatives don’t risk feeling guilty.

The interviews with physicians also contain descriptions of ethical difficulties associated with DNR decisions. Although the physicians emphasize that the decision is made on medical grounds, they also describe ethical challenges and trade-offs. The decisions seem to be especially difficult in hematology wards, where patients can get intensive treatment for a long time, and where even the treatment makes them ill, but almost up to the last moment can be regarded as treatable. Here decisions are made quickly and at a late stage. Physicians’ experiences of the decision not to resuscitate vary from experiencing that they make themselves God, to experiencing it as just one medical decision among others.

In her conclusion, Mona Pettersson emphasizes that the results indicate how DNR decisions are made not only on medical grounds (such as prognosis and prospect of surviving cardiopulmonary resuscitation). They are made also with reference also to ethical values such as autonomy and quality of life after resuscitation.

In her future research, Mona Petterson will examine the ethical skills needed in DNR decisions and how they can be learned and developed.

Pär Segerdahl

Pettersson, M. Hedström, M. and Höglund, A. Physicians’ experiences of do-not-resuscitate (DNR) orders in hematology and oncology care – a qualitative study. Journal of Palliative Care and Medicine. 2016. DOI: 10.4172 / 2165-7386.1000275

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Macchiarini and the spirit of fraudulence

February 10, 2016

Pär SegerdahlI assume you heard of Paolo Macchiarini, the “star surgeon” who, with the willpower of a general, simply would win a great battle at the frontline of research – by creating new tracheae using the patients’ own stem cells. That the endeavor had costs in terms of a few soldiers’ or patients’ lives is sad, but some losses must be accepted if one is to win a major battle in the service of cutting-edge experimental research.

It is difficult to avoid such an interpretation of Macchiarini’s mindset, after seeing the Swedish TV-documentaries about him (“Experimenten”/”The Experiments”). You feel the presence of a dominating iron will to carry out a plan and to win. It feeds a warlike spirit in which collegial doubts must be suppressed because they corrupt the morale and slow down the march forward, toward the frontline.

Truth is, as we know, the first casualty of war. Losses must be described as successes, in order not to lose readiness for action in the final battle – which, of course, will be won, don’t for a moment doubt that! The condition of patients who after surgery barely can breathe must thus be described as if the surgery had given them a nearly normal respiratory function. Macchiarini’s misconduct follows the logic of war.

Imagine this rigid winner, waiting impatiently for patients for whom his unproven methods (with some good will) could be interpreted as a last chance to survive. Does he approach the patients as a doctor who wants to offer a last treatment option? Hardly, but the possibility of interpreting the situation in such a way takes him to the frontline: he gets the opportunity to operate on them.

Does he then relate to the patients as a researcher to his participants? Not that either. For the treatment is only improvised in the heat of battle and can hardly even be called experimental; and all failures will be covered up by more scientific fraudulence.

The fact that research ethics developed in the shadow of the Second World War is hardly a coincidence. Something that worries in the Macchiarini case is that research itself – with its competition for funding and more – obviously can be animated by a warlike and strategic spirit of winning, which corrupts individuals as well as institutions…

It goes without saying that suspected research misconduct should not be investigated by the universities themselves; that there is a need for an independent body that handles such matters.

Pär Segerdahl

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Culturally sensitive ethics

November 3, 2015

Pär SegerdahlHealth care receives patients from many different cultures and health care professionals are encouraged to be sensitive to patients’ cultural background. But what is a culture? What is it one should be sensitive to?

Last week, CRB organized a workshop on Islamic perspectives on reproductive ethics. A case that was discussed was this: an unmarried Muslim couple (21 years old) seeks advice on contraception. Should health care workers provide counseling, when premarital sex is forbidden in Islam?

The case brought the question of cultural sensitivity into immediate focus for me. To what should one be sensitive: to doctrines, or to human lives? What “is” a culture: the formulated ideas or the way people live (with their ideas)?

The Muslim couple actually sought counseling. Being culturally sensitive can also mean being sensitive to this fact: that this is how people can live (with their ideas).

It is tempting to objectify cultures in terms of doctrines, especially when they are foreign to us. We don’t know the people and their daily lives, so we try to understand them through the texts – as if we read their “source code.” But the texts are living parts of the culture. They have uses, and these practices cannot be inferred from the texts.

Aje Carlbom (social anthropologist at Malmö University) stressed that this temptation to objectify other cultures can arise even in a culture; for example, when people who belong to it move to parts of the world where people live differently. Suddenly they don’t fully understand their own culture, for it lacks its real-life support, its everyday context, and therefore one turns to the texts. One’s own culture is objectified.

I wonder: Are not these tendencies extremely common; are they not in all of us? Are they not in ethics? Isn’t there a will to objectify ethics, to formulate the “ethical source code” that should govern, for example, our biomedical practices?

I think we need culturally sensitive ethics: in the sense of an ethics that responds sensitively to what is actually happening, and that contributes to meaningful contexts. An ethics that does not objectify either cultures or Ethics (capitalized).

Pär Segerdahl

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Dissertation on palliative care of children with cancer

September 21, 2015

Pär SegerdahlApproximately every fifth child who gets cancer in Sweden dies from their disease. In her dissertation work at CRB, Li Jalmsell studied the care of these children at the end of their life from both the child’s and the parents’ and siblings’ perspectives.

One of her findings is that one doesn’t generally recognize that the child’s cancer is beyond cure until very close to death, giving little time to plan palliative care based on personal preferences.

Jalmsell also did surveys with parents and siblings who lost a child/sibling, and interviewed children with cancer. The children themselves emphasize in the interviews that they want honest information, even when it is bad. But they also want the conversations to be hopeful and contain a plan ahead; and they want to be informed simultaneously with the parents (not after the parents).

The psychological suffering of parents and siblings who lost a child/sibling seems to be influenced by different factors. Parents’ suffering after the child’s death is much dependent on how they experienced the child’s suffering near the end of life. The parents’ suffering also tended to increase if the child underwent bone marrow surgery before death, perhaps because of the hope of a cure that such an intense treatment awakens.

Siblings generally felt ill-informed and unprepared for the child’s death. Siblings who didn’t get opportunity to talk about what they could expect tended to feel anxiety long after the child’s death.

Jalmsell also stresses the importance of parents talking about death with their child. Other studies have shown that parents who don’t talk often regret this afterwards; while parents who talk with the child about death don’t regret it. In Jalmsell’s own study the parents say that the initiative to talk about death often came from the child, often through stories. The child understands its situation.

If you want to read Li Jalmsell’s dissertation, you can find it here:

It emphasizes the importance of open communication with the whole family.

The public examination is on Friday, September 25, at 09:00, at the Uppsala Biomedical Centre (BMC), room A1:111a. The examination will be conducted in English. Welcome to listen and ask questions!

Pär Segerdahl


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