Patient self-experimentation makes the headlines!

What is self-experimentation?

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”.

I have also used self-experimentation in an interventional study to investigate the effects of nicotine administered via an e-cigarette on levodopa-induced dyskinesia (a troublesome side effect of Parkinson’s medication). This study is also published in a scientific journal: “Patient-driven N-of-1 in Parkinson’s disease: Lessons learned from a placebo-controlled study of the effect of nicotine on dyskinesia”. 

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. […]”

The full post is available here. 

Subsequently, I went on to successfully defend my PhD thesis at Radboud University in the Netherlands, which you can read about here:

• https://www.riggare.se/2019/07/23/but-sara/
• https://www.riggare.se/2020/07/14/phd-trajectory-update/
• https://www.riggare.se/2022/01/21/my-phd-thesis-is-now-available/
• https://www.riggare.se/2022/03/28/on-this-day-10-years-ago/
• https://www.riggare.se/2022/05/12/video-from-my-thesis-defence/

As part of the process of transferring my PhD work from Karolinska Institutet to Radboud University, together with my main supervisor, professor Bas Bloem, my co-supervisors assistant professor Maria Hägglund and Martijn de Groot, and professor of biomedical ethics Annelien Bredenoord, I wrote a commentary on ethical issues in relation to my thesis work: “Ethical Aspects of Personal Science for Persons with Parkinson’s Disease: What Happens When Self-Tracking Goes from Selfcare to Publication?”.  

What are my thoughts on what Halassy did?

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?