And EC et al decided no ethical review was requiredThis comment caught my eye...................a view highlighted by @Mithriel above..............
And EC et al decided no ethical review was requiredThis comment caught my eye...................a view highlighted by @Mithriel above..............
Do someone remember what actually happened with the SMILE trial (Lightning Process) ethical review?
I remember that there was a problem because this "treatment" was tested on children while it had never been tested on adults, which is normaly impossible. But I don't recall what on what ethical grounds it was finaly accepted.
It also strikes me that Crawley is putting herself in a position where she can cherry pick cases, as she is the one who is, presumably, diagnosing ME.
As there doesn't seem to be any independent verification of her diagnosis she could be using any old criteria she likes. Now, obviously I cannot say that she has done this, but she could simply be choosing children who do not have ME but who could be candidates for making her chosen therapy seem effective. There is no form of independent oversight or mechanism to police this.
Given how threatening this must seem to both parents and children alike, I should think that there must be an element of coercion felt by some parents and their kids. Again no layer of protection or independent analysis.
https://twitter.com/bmj_latest?ref_src=twsrc^google|twcamp^serp|twgr^author
thebmj.com - "Answering questions
Questioning answers"
.....but not answering ours !
https://twitter.com/bmj_latest?ref_src=twsrc^google|twcamp^serp|twgr^author
thebmj.com - "Answering questions
Questioning answers"
.....but not answering ours !
Basically, medical science would be great if it weren't for the patientsThe problem is some academics seem to think research funding is to further their careers not to help patients ...
Bristol Uni is about to undergo a £300m expansion............Bristol Uni.
Was there not also a " Helsinki" issue re fully informed consent?I think Crawley claimed that CFS is different in children and therefore the trial should go ahead.
I wasn't able to comment on the site, I have real difficulty with the technology so if anyone thinks it would be useful, feel free to make this point there.
I don't think DT or many ME patients get the point about an Attendance officer being present. It made my stomach turn over. Parents in the UK are often threatened with court and prison if their children don't attend school, it is used as a threat to the kids as well.
My grandson has severe anxiety and was unable to cope with secondary school. His form teacher and deputy headmistress were very good with him, though we know know it was futile as the anxiety was masking quite bad autism.
But their efforts were totally undermined by the Attendance Officer and Headmaster who wanted to make a contract with penalties for breaking it, as if he did not WANT to go but simply couldn't. Prison for mum was mentioned which did nothing for his stress levels.
A friend's granddaughter was not so lucky. I think her absences were caused by her mother's sever depression - she was scared to leave her alone, but court cases were used as threats and being sent to a residential special school felt like prison for her as well as the torment of her concern for her mother. These people have really power over the children and mess them up.
If I was meeting EC with an Attendance Officer there I would be too frightened to refuse to join her research which is coercion pure and simple.
(As an aside, my grandson was suicidal because he felt so guilty, being reassured that it was not his fault solved that problem, thank god. Being told by creepy crawly that your ME is all your own fault makes me weep for those children. How evil can you be.)
Mithriel
Its not just the BMJ who need to answer questions its Bristol University who are responsible for a trial without ethical approval.
That was PACE (unless there's been another incident), where the principal investigators didn't disclose their financial ties to the insurance industry. It appeared in the published articles, but not in the patient consent forms.Was there not also a " Helsinki" issue re fully informed consent?
I thought consent was given for research which in effect was a clinical trial, but could be wrongThat was PACE (unless there's been another incident), where the principal investigators didn't disclose their financial ties to the insurance industry. It appeared in the published articles, but not in the patient consent forms.