By David Tuller, DrPH
On Monday, The Times (UK) published a story about a 17-year-old girl with ME who has experienced hospital treatment that her family has referred to as “neglect and abuse.” The details are harrowing—but should not be unfamiliar to people aware of similar experiences reported by other teenagers with severe ME.
Parents and kids caught in the grips of practitioners at National Health Service facilities often decline to speak out about mistreatment, for fear of medical and legal repercussions. In this case, the mother, Joanne McKee, has taken the opposite step and gone public. She disseminated information on social media and spoke with the press.
Here’s the opening of the Times story:
“A mother has said an NHS hospital failed to offer her daughter adequate pain relief in a pattern of poor treatment that left the teenager suicidal.
“Ella Copley, 17, from Tingley, West Yorkshire, has suffered from ME (myalgic encephalomyelitis), sometimes known as chronic fatigue syndrome, for seven years. She has been in Leeds General Infirmary since March, when she was taken there by ambulance with an infection later diagnosed as sepsis.
“Her mother, Joanne McKee, 49, said the treatment Ella had received ‘feels like neglect and abuse.’ She has posted videos on social media of the teenager screaming in pain when medicine is given via a feeding tube into her small intestine. ‘I don’t think they believe that her pain is real at all,’ she said.“
As has been The Times’ recent practice, the story identifies the illness first as ME, adding that this condition is “sometimes known as chronic fatigue syndrome.” In fact, chronic fatigue syndrome has been the primary name in use for decades. Only in recent years have efforts by the patient community to reclaim the older name “myalgic encephalomyelitis” achieved some success. So The Times‘ linguistic position on this matter seems notable to me. (Government agencies in the UK and the US now routinely use the term ME/CFS.)
What’s also interesting is that The Times has chosen to highlight this dispute at all. I mean, disputes between patients and hospitals over treatment approaches are not that unusual. In general, ME has not been on the radar of journalists as a particularly credible or necessary domain to cover. Lots of diseases have a sexier public image, even more so if they have a celebrity sufferer or two. Like migraines and Khloe Kardashian!
A few years ago, I think a conflict of this kind involving ME would have have been much less likely to receive the kind of sympathetic and high-profile attention provided by The Times. For the most part, the misguided views of a group of powerful experts have dominated this field of medicine. Many journalists have accorded this self-promoting lot far too much deference while doubting or questioning the accounts of patients.
In May, when the UK government announced a new initiative on ME/CFS, Sean O’Neill, a longtime Times reporter, wrote a heartbreaking article about his 27-year-old daughter, Maeve, who had died from the illness last October. In the previous year, O’Neill had written a series of articles documenting the many challenges confronting ME patients. An inquest into the circumstances surrounding Maeve’s death has been scheduled for next month.
The Times’ science editor, Tom Whipple, has written some accurate and timely articles on the controversy over ME, including a 2018 story about an open letter to The Lancet that was signed by 100+ experts and criticized the PACE trial’s “unacceptable methodological lapses.” (I organized and sent the open letter.) But I hope and assume that Sean O’Neill’s writings in particular have sensitized his journalism colleagues–not just at the Times but also at other news organizations–to some of the life-and-death realities of ME.
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Norway’s unfortunate decision on Lighting Process study
I have written frequently about the Lightning Process, most recently about a proposed clinical trial in Norway. On July 13th, NEM, the Norwegian research ethics authority, announced that it has approved the trial, even though the proposal remains riddled with methodological and ethical problems.
This was the second go-round for this study. Last year, a previous proposed version was also approved at the regional level but was rejected by the NEM. This year’s NEM panel included members who were not involved last year. The NEM decision is final.
Patient advocate and writer Nina Steinkopf has extensively covered the debate around this trial on her blog, MElivet. Here’s the start of Steinkopf’s most recent post:
“A long-planned study where 100 ME patients will be treated with the alternative method Lightning Process received ethical approval in 2020. Following complaints, the approval was withdrawn in 2021. After a minor adjustment in the study design, the project received new ethical approval. New complaints have not been taken into account.”
This was not a unanimous decision. Three of the 12 members on the NEM panel dissented from the majority, and reiterated concerns raised by the Norwegian ME Association and other critics of the study. In its report on the ruling, NEM outlined the concerns raised by these dissenters:
“The minority…believe that the change that has been made [to address concerns about the proposed study] is not sufficient to make the research ethically sound. The minority believes that the research fellow’s strong self-interest and prominent role in the project must be offset by a solid research method if the results are to have credibility. The primary endpoint of the study is based on a questionnaire with self-evaluation of symptoms and function. This is less suitable as an objective evaluation if there is real doubt about the researchers’ independence, and the validity of the answers also becomes uncertain when a central part of the course consists of learning verbal reformulations of one’s own experiences.
“The minority further believes that the potential for physical side effects has not been sufficiently taken into account, as the participants may have unknown underlying diseases. One of the characteristics of CFS / ME, based on the criteria by which the project itself operates, is precisely effort-induced fatigue, and the risk for vulnerable participants therefore appears to be real.
“In line with the rest of the committee, the minority also wants increased research on the treatment of CFS / ME. Due to a controversial field, it is important that the research is based on a solid method and that it appears independent in order to achieve credibility. The combination of self-interest and not very objective outcome measures means that the committee’s minority considers the potential benefit of the research project to be small. Based on an overall assessment, the minority finds that the project is not ethically justifiable to carry out in its current form.”
Although the majority added some extra conditions for the trial regarding disclosures and data access, the substantive concerns articulated by the panel members in the minority were apparently not convincing to their colleagues. So this flawed research project will proceed.
It is remarkable that presumably sophisticated and science-savvy panel members could find this particular study of this particular intervention to be adequate to the task of producing actionable knowledge. Even putting aside conflict-of-interest concerns, if an intervention induces you to think that acknowledging symptoms or illness means you’re failing, then you’re less likely to acknowledge symptoms or illness at follow-up compared to patients who haven’t received the intervention.
That shouldn’t be so complicated to understand. But the logic apparently doesn’t seem to translate well into Norwegian.