MAGICAL MEDICINE: HOW TO MAKE AN ILLNESS ... - Invest in ME

289
Section B covers “Basic principles for all medical research”.
B11 states: “Medical research involving human subjects must conform to generally accepted scientific principles (and)
be based on a thorough knowledge of the scientific literature”.
B13 states: “The researcher should also submit to the committee, for review, information regarding funding,
sponsors, institutional affiliations (and) other potential conflicts of interest”.
B17 states: “Physicians should abstain from engaging in research projects involving human subjects unless
they are confident that the risks involved have been adequately assessed”.
B19 states: “Medical research is only justified if there is a reasonable likelihood that the populations in
which the research is carried out stand to benefit from the results of the research”.
B 20 states: “The subjects must be volunteers and informed participants in the research project”
B21 states: “Every precaution should be taken to respect the privacy of the subject (and) the confidentiality
of the patient’s information”.
B22 states: “Each potential subject must be adequately informed of the aims, methods, sources of funding,
any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and
potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from
participation in the study or to withdraw consent to participate at any time without reprisal”
B23 states: “When obtaining informed consent…the physician should be particularly cautious if the subject
is in a dependent relationship with the physician or may consent under duress”.
It appears that the PACE Trial does not conform to the Declaration of Helsinki in full, for example:
• patients and participants have asserted that coercion was used (breaching A8, B20 and B22)
• participants’ confidential data was not kept securely and was stolen (breaching B21)
• the Investigators ignored the scientific literature that differentiates ME/CFS from “chronic
fatigue” (breaching B11)
• the Investigators already know (as does Wessely, who oversees the PACE Trial Clinical Unit) that
“These interventions are not the answer to CFS” (Editorial: Simon Wessely; JAMA 19 th September
2001:286:11) and that “many CFS patients, in specialised treatment centres and the wider world, do
not benefit from these interventions” (Huibers and Wessely; Psychological Medicine
2006:36:(7):895‐900) (breaching B19)
• the Investigators’ conflicts of interest were initially denied (breaching B22)
• participants were not informed of the potential risks inherent in the trial, in particular they were
not informed about the known adverse consequences of aerobic exercise for patients suffering from
ME/CFS, for example, the effects of increased oxidative stress; the effects on cardiac output and
function, or the effects of exercise on the (already disordered) immune system of ME/CFS patients
(breaching A5, B20 and B22).