Visst känner du till Helsingforsdeklarationen? Den antogs första gången för 60 år sedan av World Medical Association (WMA) och fastslår ett antal etiska principer att beakta i medicinsk forskning. Helsingforsdeklarationen är inte juridiskt bindande men har haft stor inverkan på lagstiftning och regelverk i hela världen, inte minst i Sverige.
I samband med WMA:s 75:e General Assembly i oktober 2024 så fastslogs även en uppdatering av Helsingforsdeklarationen med en rad viktiga förändringar, se länk till hela den uppdaterade deklarationen här.
Den allra viktigaste förändringen är att man genom hela dokumentet ändrat ordet “subjects” till “participants”. Detta utgör en omvälvande förändring i synen på de som deltar i forskningen. En person som är “research subject” blir studerad och har en passiv roll medan en “research participant” kan ha en mer aktiv roll i forskningen. WMA anger själva att förändringen gjorts för att på ett tydligare sätt visa att man som forskare måste respektera rättigheterna hos personerna som medverkar i forskningen och visa hur viktiga de är.
En annan viktig förändring är att man ändrat från att använda uttrycket “vulnerable groups and individuals” till att istället skriva “individual, group, and community vulnerability”. Det kanske kan verka som hårklyverier men denna förändring signalerar en mycket viktig perspektivförflyttning. Den tidigare formuleringen innebar att sårbarheten på sätt och vis sågs som en egenskap som grupper eller individer har, vilket blir olyckligt. Med den nya formuleringen vill WMA signalera att sårbarhet inte är statisk utan i hög grad föränderlig och till stor del beror av sammanhanget man just då befinner sig i.
Den tredje förändringen jag vill nämna är ett helt nyskrivet stycke som lagts till i denna version. På engelska står det i paragraf 6, tredje stycket:
Meaningful engagement with potential and enrolled participants and their communities should occur before, during, and following medical research. Researchers should enable potential and enrolled participants and their communities to share their priorities and values; to participate in research design, implementation, and other relevant activities; and to engage in understanding and disseminating results.
Jag har tillsammans med ChatGPT gjort en översättning/bearbetning:
Före, under och efter att medicinsk forskning genomförs så bör potentiella och registrerade deltagare samt deras föreningar, organisationer eller nätverk ges möjlighet till medverkan med mening (min översättning/tolkning av “meaningful engagement”). Forskare bör möjliggöra för potentiella och registrerade deltagare samt deras föreningar, organisationer eller nätverk att dela med sig av sina prioriteringar och värderingar, delta i forskningsdesign, genomförande och andra relevanta aktiviteter samt engagera sig i att förstå och sprida resultat.
Dessa förändringar är för mig en tydlig signal om att vår gemensamma syn på medicinsk forskning och dess roll i världen håller på att förändras. Jag gläds åt den stärkta synen på patienter och forskningsdeltagare som detta förmedlar.
På vilket sätt kommer den nya versionen av Helsingforsdeklarationen förändra din forskning?
Sanctorio sitting in the balance that he made to calculate his net weight change over time after the intake and excretion of foodstuffs and fluids.
Self-experimentation is a type of single-subject research where the researcher and the research subject are one and the same. This is a practice with ancient traditions and prominent examples exist throughout history. Some of the more well-known include: The Italian physician Sanctorius of Padua (1561-1636) who is considered the father of experimental physiology, largely as a result of him for thirty years using a ”weighing chair” to weigh himself, everything he ate and drank, as well as the urine and faeces he excreted. This led to him formulating new theories about our metabolism, some of which are still valid today. Another example is the German physician and researcher Werner Forssmann (1904-1979) who in 1929 performed the world’s first heart catheterisation, on himself. A more recent example is the Australian physician Barry Marshall who in 1984 infected himself with Helicobacter pylori, thereby proving that stomach ulcers are the result of a bacterial infection. Both Forssmann and Marshall were rewarded with Nobel prizes for their discoveries.
What happened the other day?
And just the other day, self-experimentation made the headlines of Nature, one of the most prestigious scientific journals in the world. The article is titled “This scientist treated her own cancer with viruses she grew in the lab” and is definitely worth reading. It is about the Croatian virologist Beata Halassy who, after getting her second recurrence of breast cancer, combined her virology training with self-experimentation and administered oncolytic virotherapy to herself. Her oncologists agreed to monitor her and they are also coauthors to the scientific article in the journal Vaccines describing the study. The study was rejected by more than a dozen journals before being published by Vaccines and Halassy says that the reason for the rejections was ethical concerns. There are certainly plenty of interesting ethical challenges here and I would like to focus on a specific section in the Nature article, where law and medicine researcher Jacob Sherkow comments:
“The problem is not that Halassy used self-experimentation as such, but that publishing her results could encourage others to reject conventional treatment and try something similar, says Sherkow. People with cancer can be particularly susceptible to trying unproven treatments. Yet, he notes, it’s also important to ensure that the knowledge that comes from self-experimentation isn’t lost. The paper emphasizes that self-medicating with cancer-fighting viruses “should not be the first approach” in the case of a cancer diagnosis.
“I think it ultimately does fall within the line of being ethical, but it isn’t a slam-dunk case,” says Sherkow, adding that he would have liked to see a commentary fleshing out the ethics perspective, published alongside the case report.”
These are relevant and important points and I would like to share my thoughts on this.
What are my experiences of ethical issues relating to self-experimentation?
I have some personal experience from self-experimentation myself, although of a much less invasive nature. In one study I used an observational design to better understand how the effects from my medications vary over the day. I take a lot of pills to reduce my Parkinson’s symptoms. The pills have to be taken several times every day and the medication effect waxes and wanes as the substances in the pills are being taken up and metabolised in my body. This study is published in a scientific journal: “Precision Medicine in Parkinson’s Disease – Exploring Patient-Initiated Self-Tracking”.
In 2018, my application to defend my PhD thesis at Karolinska Institutet was rejected, see a small excerpt from the decision of the Dissertation Committee here:
”[…] The primary focus of this process has been the issue of ethical approval and the conclusion is that The Ethical Review Act does not make exceptions for research on persons who themselves are scientifically involved in the study. […]”
From a patient perspective, I completely understand why Halassy did what she did. She found herself faced with a personal health challenge with huge implications. For her it was literally a matter of life or death. At the same time, she had access to knowledge and resources that she could use to potentially address her problem, and hopefully survive. Of course she felt she had to do what she could with what she had at her disposal! In this case, my guess would be that there are few people in the world more suited than Halassy to make a genuinely informed decision about this specific treatment and the risks involved. And, in fairness, that was also what Sherkow said in the Nature article: the problem was not that Halassy had used self-experimentation.
Sherkow went on to say that the actual problem was that she had published her results, because “her results could encourage others to reject conventional treatment and try something similar”. Let me unpack that statement a bit: Is it reasonable to think that others with breast cancer would reject conventional treatment based on the publication of this study? I genuinely don’t think that is a likely scenario, for several reasons. First and foremost, very few patients have the knowledge needed and access to a virology lab. So why and how could the publication result in others rejecting conventional treatment? And if they did reject conventional treatment, for whatever reason, surely that is their prerogative?
To me, Sherkow’s statement seems to be an example of epistemic injustice in action, and in this case testimonial injustice, which according to the Wikipedia entry means “unfairness related to trusting someone’s word. An injustice of this kind can occur when someone is ignored, or not believed, because of their sex, sexuality, gender presentation, race, disability, or, broadly, because of their identity.” Before we ”become patients”, we have been able to live an independent life with responsibilities, obligations, and human rights. Why would we suddenly become unable to make our own decisions, just because we have been diagnosed with a life-altering medical condition, for example cancer?
In contrast, I would like to ask: Would it have been ethical by Halassy and her coauthors NOT to have published what they learned from this?
(This blog post is also available in Swedish =>> here)
Most people living with Parkinson’s disease take a lot of pills, multiple times a day. After having Parkinson’s for a while, it’s not uncommon to be prescribed 3-4 different types of medications to be taken in various combinations 4-6 times each day. One of my medications is an extended-release type, which means that the pill slowly dissolves in the body, and therefore, at least in theory, it’s sufficient to take it only once a day. When I started taking that medication, I did exactly that, took it once every day, in the morning. After the usual “adjustment problems” such as a bit of nausea and similar issues for a few weeks, I felt confident that the addition of this medication did indeed make it a bit easier for me to move around.
After some time however, I noticed that the positive effect was noticeable in the morning but the pill didn’t give me as much of an effect later in the afternoon. During my next neurologist visit, I mentioned this to him. I knew that the same medication was available also in other dosage strengths so I asked him if maybe he could prescribe it to me in a lower strength so that I could spread out my intakes of the extended-release formulation over the day. In this way, I could take lower doses at several different times instead of taking only one higher dose tablet in the morning. He considered this for a few seconds and said: “According to the information from the pharmaceutical company, it really should be enough to take this medication only once a day, and it does seems inconvenient to take it at multiple times. But if you really want to, you can try.” I left the clinic with a new prescription and was curious to see how this new dosing would work out.
Classification of patient knowledge by source of learning. (From: Dumez, V., & L’Espérance, A. (2024). Beyond experiential knowledge: A classification of patient knowledge. Social Theory & Health.)
It should come as no surprise that I strongly believe that the improvement of healthcare should be done together with patients, and I recently came across a scientific article that made me see patient involvement in a completely new light: “Beyond experiential knowledge: a classification of patient knowledge” written by Vincent Dumez and Audrey L’Espérance. They identify six types of patient knowledge from three main sources of patient learning, see the Figure. You can read a separate post about that article here, and most important is that Dumez and L’Espérance made me aware of the concept of patients’ experiential knowledge. I also went through that article’s reference list (a good way to find other relevant scientific articles in a particular field) and found a very interesting article published back in 1976: “Experiential Knowledge: A New Concept for the Analysis of Self-Help Groups” written by Thomasina Borkman. There, experiential knowledge is described as “first-hand knowledge,” meaning knowledge obtained from personal experience with a phenomenon, as opposed to knowledge that comes from reasoning, observation, or reflection based on information provided by someone else. I have written a separate post also for this article (link here).
So what? Why is this important?
What does this mean then? In what way do these two scientific articles relate to patient involvement? This is my take: Through their education and professional work, healthcare professionals have acquired theoretical knowledge. They have also gained experiential knowledge through their professional practice. Of course, both of these aspects are very important when you want to improve and further develop healthcare. And if you live 24/7 with illness, disabilities, and the need for help and support from healthcare and society, AKA patients, you gain experiential knowledge. That kind of knowledge cannot be gained theoretically. You cannot get experiential knowledge from reading a textbook or a scientific article, it can only be acquired through living it.
This means that without also having direct access to patients’ experiential knowledge, healthcare professionals do not have the full picture and therefore cannot solve the problem at hand: to optimize individual health, in the best way.
Finally
You might wonder what happened when I started taking the extended-release medication several times a day instead of just once every day. Well, as usual when making medication changes, there were some initial adjustment issues when I went from a higher dose once a day to several lower doses. After that, it became very clear to me that this way of using the medication gave me a noticeably more consistent effect. I shared this with my neurologist, and later I heard from other people with Parkinson’s who also go to him that he started prescribing this extended-release tablet in the same way to other patients as well.
In conclusion: involving patients in improving and further developing healthcare is important because it ensures that healthcare is based on the actual priorities that patients have, rather than the priorities that healthcare professionals think that patients have.
(This blog post is also available in English =>> here)
De flesta som lever med Parkinsons sjukdom tar många piller, ofta flera olika sorter och flera gånger varje dag. När man haft Parkinson ett tag så är det inte ovanligt med 3-4 olika typer av mediciner som tas i olika kombinationer vid 4-6 tillfällen varje dag. En av mina mediciner är av depot-typ, vilket innebär att pillret löses upp långsamt i kroppen och därmed kan man, iallafall i teorin, ta just den medicinen bara en gång per dag. När jag började ta den medicinen så tog jag den just så, en gång varje dag, på morgonen. Efter de vanliga “inkörningsproblemen” såsom lite illamående och liknande under några veckor så kunde jag konstatera att jodå, tillägget av denna medicin gjorde att jag kunde röra mig lite lättare. Men efter en tid så upptäckte jag att den positiva effekten var tydlig på morgonen och förmiddagen men den avtog under senare delen av eftermiddagen. Vid nästa besök hos min neurolog tog jag upp detta. Jag hade tagit reda på att samma medicin fanns även i andra styrkor, både högre och lägre så jag frågade honom om han kanske kunde skriva ut den till mig i lägre styrka så att jag kunde sprida ut mina intag av depot-tabletten över dagen. På så sätt kunde jag ta den i lägre dos vid flera olika tillfällen istället för att ta endast en tablett i högre dos på morgonen. Han funderade några sekunder och sa sedan: “Enligt informationen från läkemedelsbolaget så ska det räcka att ta denna medicin en gång per dag och det verkar ju besvärligt att ta den vid flera tillfällen. Men om du verkligen vill det så kan kan du få prova.” Jag gick därifrån med ett nytt recept på fickan och var nyfiken på hur det skulle bli med den nya doseringen.
I vividly remember the first time I realized that my neurologist and I are in possession of vastly different although complementary types of knowledge. At the time, I had been a patient of his for a couple of years and in between appointments, I would write my questions about Parkinson’s disease (PD), my treatment, and other things that I thought were related to my condition on a list that I brought to my next visit. He would patiently answer my questions as best he could and on the subway going home from the clinic, I would start my next list.
I recently came across a very interesting scientific article, published almost 50 years ago, with concepts that are definitely still relevant and important today:
