Mind the brain blog post, by Prof James Coyne, 23 September 2016: Before you enroll your child in the MAGENTA chronic fatigue syndrome study: Issues to be considered
Petitions are calling for shutting down the MAGENTA trial. Those who organized the effort and signed the petition are commendably brave, given past vilification of any effort by patients and their allies to have a say about such trials.
Below I identify a number of issues that parents should consider in deciding whether to enroll their children in the MAGENTA trial or to withdraw them if they have already been enrolled. I take a strong stand, but I believe I have adequately justified and documented my points. I welcome discussion to the contrary.
This is a long read but to summarize the key points:
- The MAGENTA trial does not promise any health benefits for the children participating in the trial. The information sheet for the trial was recently modified to suggest they might benefit. However, earlier versions clearly stated that no benefit was anticipated.
- There is inadequate disclosure of likely harms to children participating in the trial.
- An estimate of a health benefit can be evaluated from the existing literature concerning the effectiveness of the graded exercise therapy intervention with adults. Obtaining funding for the MAGENTA trial depended on a misrepresentation of the strength of evidence that it works in adult populations. I am talking about the PACE trial.
- Beyond any direct benefit to their children, parents might be motivated by the hope of contributing to science and the availability of effective treatments. However, these possible benefits depend on publication of results of a trial after undergoing peer review. The Principal Investigator for the MAGENTA trial, Dr. Esther Crawley, has a history of obtaining parents’ consent for participation of their children in the SMILE trial, but then not publishing the results in a timely fashion. Years later, we are still waiting.
- Dr. Esther Crawley exposed children to unnecessary risk without likely benefit in her conduct of the SMILE trial. This clinical trial involved inflicting a quack treatment on children. Parents were not adequately informed of the nature of the treatment and absence of evidence for any mechanism by which the intervention could conceivably be effective. This reflects on the due diligence that Dr. Crawley can be expected to exercise in the MAGENTA trial.
- The consent form provides for the MAGENTA trial involves parents granting permission for the investigator to use children and parents’ comments concerning effects of the treatment for its promotion. Insufficient restrictions are placed on how the comments can be used. There is the clear precedent of comments made in the context of the SMILE trial being used to promote the quack Lightning Process treatment in the absence of evidence that treatment was actually effective in the trial. There is no guarantee that any comments collected from children and parents in the MAGENTA trial would not similarly be misused.
- Dr. Esther Crawley participated in a smear campaign against parents having legitimate concerns about the SMILE trial. Parents making legitimate use of tools provided by the government such as Freedom of Information Act requests, appeals of decisions of ethical review boards and complaints to the General Medical Council were vilified and shamed.
- Dr. Esther Crawley has provided direct, self-incriminating quotes in the newsletter of the Science Media Centre about how she was coached and directed by their staff to slam the patient community. She played a key role in a concerted and orchestrated attack on the credibility of not only parents of participants in the MAGENTA trial, but of all patients having chronic fatigue syndrome/ myalgic encephalomyelitis , as well as their advocates and allies.
I am not a parent of a child eligible for recruitment to the MAGENTA trial. I am not even a citizen or resident of the UK. Nonetheless, I have considered the issues and lay out some of my considerations below. On this basis, I signed the global support version of the UK petition to suspend all trials of graded exercise therapy in children and adults with ME/CFS. I encourage readers who are similarly in my situation outside the UK to join me in signing the global support petition.