On 4 August 2010 The ME Association and The Young ME Sufferers Trust (Tymes Trust) issued a joint statement that expressed a number of concerns about the proposal to carry out a feasibility study, involving children and adolescents with ME/CFS, into the use of the Lightning Process.
We also sent a copy of this statement to the Department of Health with a request that it should be forwarded to the ethics committee that will be examining this proposal. This is because we believe the ethics committee should be aware of widespread concerns being expressed by people with ME/CFS about the trial.
Our statement also contained information about an adjudication from the Advertising Standards Authority and interventions by several trading standards officials – both in relation to therapeutic claims being made for the Lightning Process which we believe the ethics committees must be aware of when reviewing this proposal.
The Department of Health have refused to forward this information to the ethics committee on the grounds that:
We expect research ethics committees to consider all the relevant evidence, but they have to be seen do so objectively and impartially and to arrive at their decisions independently if they are to command public confidence and the credibility of all the stakeholders concerned. For this reason, it would be inappropriate, as well as potentially counterproductive, expressly to bring your joint statement to the attention of the research ethics committee reviewing the proposal for this project.
We profoundly disagree with the DoH’s reasoning, which we consider carries serious implications for the integrity of the scientific process. Whether or not an ethics committee membership is confidential, it should still be possible for essential evidence to be supplied to them. How else can the public be assured that an ethics committee has all the relevant evidence to consider before reaching its decision?
The two charities are unable to forward this statement direct because the identity and location of the relevant ethics committee is not in the public domain.
We are now considering what further action to take.