From GMC 26th May 2011
I refer to our previous correspondence regarding your complaint about Dr Esther Crawley.
We have now completed our enquiries into your complaint and both a medical and a non-medical case examiner have considered the case. Case examiners are senior GMC staff, appointed to make decisions on cases.
The case examiners have now reviewed your complaint and the additional information we collected through our enquiries. They have decided to conclude your complaint with no further action.
The case examiners found as follows:
“The complaint alleges that Dr Esther Crawley, an honorary consultant paediatrician, was dishonest in her application for ethics approval of her research project, Assessing the feasibility and acceptability of comparing the Lightning Process®with specialist medical care for Chronic Fatigue Syndrome or Myalgic Encephalopathy (CFS/ME) – pilot Randomised Controlled Trial.”
The Lightning Process® (LP) is a commercially marketed course aimed at people with symptoms of CFS or ME. LP is a non medical intervention based on the model that body and mind interactions affect health. LP strategies are taught to self-referred patients with the aim that they can learn to alter these interactions in ways that have a positive impact on their health state. Dr Crawley’s research project is clearly stated to be a feasibility study only: Its overall aim is “to study the feasibility and acceptability of conducting a randomized controlled trial (RCT) to investigate the effectiveness and cost effectiveness of Specialist Medical Care compared to Specialist Medical Care plus the Lightning Process in treating CFS/ME in children”. The stated study rationale is as follows:
”This is important because over 250 children a year receive the Lightning Process for CFS/ME and there are currently no reported studies investigating the effectiveness or complications of the Lightning Process in children. As with all interventions, proper evaluation is necessary.
Before doing an RCT we need to know whether recruitment is possible and acceptable to families. We need to understand more about the differences and similarities between both interventions in terms of process, design, and setting. In addition, we need to develop appropriate outcome measures for any trial and test the feasibility and acceptability of investigating the health economic consequences of each intervention.”
The bundle includes a copy of Dr Crawley’s NHS REC (Research Ethics Committee) application (including the information sheets for prospective participants and their parents); an extract from minutes of a 2 December 2010 meeting of South West Research Ethics Committee (SWREC) to consider objections to this study which has been forwarded from the National Research Ethics Service (NRES); Dr Crawley’s Rule 4 response to the complaint.
The Case Examiners are asked to consider all of the evidence in this case and to establish if there is a realistic prospect of proving that Dr Crawley‘s fitness to practise is impaired to a degree that would justify action being taken on her registration status. This is known as the realistic prospect test.
The specific allegations are listed and considered below:
Dr Crawley knowingly provided false information in an application for research ethics approval
Both complainants allege that Dr Crawley misled SWREC by giving factually incorrect information and failing to disclose information relevant to gaining ethical consent.
a) Mr X alleges that, in order to circumvent the regulation preventing research involving children that could reasonably be done with adult subjects, Dr Crawley stated in her REC application: “CFS/ME is different in children and adults with different risk factors, course and outcome. It is therefore not possible to complete a study in adults and extrapolate the results to children.” Mr X argues that Dr Crawley would have been aware of the LP company’s claims that roughly the same percentage of children and adults with CFS/ME has a positive response to the LP device. Mr X appears to regard the LP company’s claims as scientific evidence that calls into question Dr Crawley’s rationale for conducting research involving children as subjects.
The Case Examiners have reviewed all the documents provided by the complainants and Dr Crawley and cannot find any evidence from peer-reviewed randomised controlled trails that demonstrates similarities/differences of CFS/ME in adults and children or that supports the efficacy or otherwise of LP. They note that SWREC considered Dr Crawley’s rationale to be legitimate.
b) Ms Y alleges that Crawley failed to provide evidence to justify the research; failed to declare the study as a clinical trial; failed to disclose risks to participants; put participants at unjustifiable risk; undermined patients’ parent’s rights to give informed consent.
The Case Examiners have reviewed the REC application (including the patient information sheets) and are satisfied that none of these allegations is supported on an evidential basis. They also point out that the core duty of RECs is to satisfy themselves on these matters and that SWREC has no concerns.
The realistic prospect test is not met in relation to this allegation.
Dr Crawley allowed a study researcher to induce patients to volunteer as study participants on the promise of therapeutic benefit
Mr X alleges that Dr Crawley permitted Mr Philip Parker, designer and developer of LP, to recruit children to her study by making unsubstantiated claims about the efficacy of LP.
The Case Examiners have reviewed the documents provided by the complainant and cannot find any evidence that Mr Parker, or any claims that he may or may not have made about LP, had any influence on the design or proposed conduct of Dr Crawley’s feasibility study. Recruitment and consent procedures are clearly described and do not involve Mr Parker or any LP practitioners
The Case Examiners make the observation that any action which may have been taken by the Advertising Standards Authority (ASA) in respect of persons making unsubstantiated claims about the benefits of LP has no bearing on the feasibility study being conducted by Dr Crawley. They note that SWREC satisfied itself on this matter when it re-reviewed Dr Crawley’s REC application in the wake of complaints from Mr X and others.
The realistic prospect test is not met in relation to this allegation.
Dr Crawley had a financial interest in the organisation marketing LP
Dr Crawley did not declare in her ethics approval application that she had conflicts of interest
The complainant did not provide any evidence to substantiate these allegations. The SWREC minutes show that it was satisfied that Dr Crawley did not have any conflicts of interest. The realistic prospect test is not met in relation to this allegation.
The Case Examiners are satisfied that Dr Crawley’s REC application was appropriately scrutinised and approved by SWREC and then fully re-reviewed by SWREC in the light of objections received by NRES. They note that SWREC upheld the decision to give ethics approval to this research project, with only minimal changes to the Patient Information Sheets. The Case Examiners conclude that there is no merit in these complaints. The case can be closed with no further action.”
I hope that I have been able to explain clearly our reasons for concluding this case. Please contact me on my direct dial number if you have any questions.
Fitness to Practise Directorate
Direct Dial: 0161 923 6432
Fax No: 0161 923 6401
From complainant’s reply 6th June 2011 –
The case examiners demonstrated that some of the complaints may be easily upheld, and other areas of complaint have not been addressed in full.
“The Case Examiners have reviewed all the documents provided by the complainants and Dr Crawley and cannot find any evidence from peer-reviewed randomised controlled trails that demonstrates similarities/differences of CFS/ME in adults and children or that supports the efficacy or otherwise of LP.” This finding confirms that Dr. Esther Crawley failed to justify why this research should be done on children before adults.
The GMC response did not address the matter of Dr. Crawley’s use of paediatric patients in collaboration with illegal traders – Phil Parker and The Phil Parker Group of Lightning Process practitioners – including directing patients and research participants to share confidential medical information on the LP application form; or the matter of coercion to participate in research as the participants are the chief investigator’s own patients recruited at her specialist clinic at the point of diagnosis and as the information they are required to read about the intervention comprises promotional sales material.