I posted the comment below to the Virology Blog re David’s article on Jonathan’s paper and thought it also relevant and perhaps useful here. I would only add that the Montgomery Judgement has retrospective force applying to any treatments administered since at least 1998 and possibly earlier:
Comment posted on Virology Blog.
Clearly the conclusion reached by Professor Edwards that:
“The simplest, and I think robust, analysis is that management of patients with stimulus challenge, often in the context of unsubstantiated diagnoses and outside established guidelines, has caused a huge amount of avoidable distress and needs to be abandoned. It has become clear that the challenge approach was never validated before use, and subsequent studies have shown no evidence of efficacy. Theories about psychosocial factors have failed to stand up; methods used to corroborate them have been poor, but good enough to show that the theories are flawed.’
reflects the situation described at paragraph 84 in the Montgomery Judgement referenced by Professor Edwards as setting out the legal situation around the need for Doctors to gain the patients ‘informed consent’ to medical treatment:
84. Furthermore, because the extent to which a doctor may be inclined to discuss
risks with a patient is not determined by medical learning or experience, the
application of the Bolam test to this question is liable to result in the
sanctioning of differences in practice which are attributable not to divergent
schools of thought in medical science, but merely to divergent attitudes
among doctors as to the degree of respect owed to their patients.
The Montgomery judgement sets aside the Bolam Test and reaffirms the long standing legal and ethical position that Doctors and other Health Care Professionals owe their patients/clients a ‘Duty of Care’ as described in paragraphs 82 and 83:
82. In the law of negligence, this approach entails a duty on the part of doctors
to take reasonable care to ensure that a patient is aware of material risks of
injury that are inherent in treatment. This can be understood, within the
traditional framework of negligence, as a duty of care to avoid exposing a
person to a risk of injury which she would otherwise have avoided, but it is
also the counterpart of the patient’s entitlement to decide whether or not to
incur that risk. The existence of that entitlement, and the fact that its exercise
does not depend exclusively on medical considerations, are important. They
point to a fundamental distinction between, on the one hand, the doctor’s role
when considering possible investigatory or treatment options and, on the
other, her role in discussing with the patient any recommended treatment and
possible alternatives, and the risks of injury which may be involved.
83. The former role is an exercise of professional skill and judgment: what risks
of injury are involved in an operation, for example, is a matter falling within
the expertise of members of the medical profession. But it is a non sequitur
to conclude that the question whether a risk of injury, or the availability of an
alternative form of treatment, ought to be discussed with the patient is also a
matter of purely professional judgment. The doctor’s advisory role cannot be
regarded as solely an exercise of medical skill without leaving out of account
the patient’s entitlement to decide on the risks to her health which she is
willing to run (a decision which may be influenced by non-medical
considerations). Responsibility for determining the nature and extent of a
person’s rights rests with the courts, not with the medical professions.
Professor Edward’s intervention in this paper is a much-needed reminder of the primary importance of the Medical Ethics principle of:
‘First do no harm’ which rests on the need to respect the patients right to the giving or withholding of the patient’s ‘fully informed’ consent to any recommended medical treatment.
That patient ‘right’ has the force of law behind it and not to respect that ‘right’ is to be ‘negligent’ towards the patient as defined by that law.
Clearly those patients to whom the ‘challenge approach’ has been widely recommended and applied as a valid treatment should have been informed by the prescribers it had not in fact been and has never been ‘validated’ at any stage. Patients are routinely not so informed and in fact often told the opposite. If they had been advised as Professor Edward’s now suggests, then the ‘huge amount of avoidable distress’ referred to by Professor Edward’s would not have occurred in the first place.
It is a fact that countless numbers of ME/CFS patients have over the last 30 plus years been granted State financial support after challenging at law a refusal of such support on medical advice that ME/CFS was not a physical illness but a psychological/behavioural illness. Those diagnosing ME/CFS as not physical could not and cannot provide the Courts with any evidence to substantiate their diagnosis or their treatment approach of denying access to that financial support. They have not so far abandoned this behavioural/psychological approach to ME/CFS despite their prolonged failure both scientifically and legally to substantiate their diagnosis or treatments.
That such a paper needed to be written, and questions remain for this writer as to whether it will succeed in meeting its objective of the abandonment of the invalidated and failed theory of stimulus challenge with regard to ME/CFS, poses serious questions around the regulation of Medical Practice.
This Paper is not simply about a medical or scientific argument between health care professionals but a fundamental examination about whether Doctors are demonstrating, the required by law, respect for the rights of individual patients within the delivery of medicine/health care to them.
This Paper clearly demonstrates that in the medicine and science around ME/CFS Doctors are not showing the required respect. It clearly describes the reasons why they are failing and what needs to be done to correct this failure.
Professor Edward’s is to be thanked not only for the clear common sense in this paper, but also for the respect he clearly demonstrates towards the ‘human rights’ of patients.
