Wednesday, October 22, 2014

More egregious claims from Saatchi bill opponents

More egregious claims from Saatchi bill opponents

For all the claims by Saatchi Bill opponents about PR and spin, they seem very happy to engage in it themselves. Lawyers re-Tweeting claims that are legal nonsense seems rather unethical, but they seem content to implicitly endorse the claim by Dr David Nicholl that the Saatchi Bill would leave medics open to charges of "wilful neglect" for failing to provide any untried, even wacky, treatments their patients demand. https://www.opendemocracy.net/ournhs/david-nicholl/saatchi%27s-%27medical-innovation-bill%27-will-benefit-lawyers-and-charlatans-not-pat#.VEevO8uIwrI.twitter
His point about the dangers of untried treatments also applies to research trials. There have been several disastrous trials of medicines which have resulted in serious illness - take for example the testing of TGH1412. 
The Saatchi Bill is nothing to do with the requirement for good clinical research after all - that has been made very clear. Dr Nicholl also claims clinical trials were expedited for situations like the Ebola epidemic. He ignores the compassionate use of untested medicine ZMapp for some victims of Ebola, which illustrates the need for the use of innovative treatments. 
Stating that the infrastructure for clinical trials needs to be improved is rather missing the point. There are many rare disorders (which are common collectively) where the administration of clinical trials with sufficient numbers is extremely difficult. Where there are no or very few treatment options available, innovation rather than waiting for the ponderous machine of the PRCT to grind into action is still the ethical way to proceed. Putting the faceless interests of "science" before concern for patients is not really good ethics. 
The Saatchi Bill is about encouraging responsible innovation. The inference that it is a quack's charter cannot be sustained upon examination of the bill, which emphasizes the qualifier "responsible" or "responsibly" several times.
1 Responsible innovation
(1) The purpose of this Act is to encourage responsible innovation in medical
treatment (and accordingly to deter irresponsible innovation).
(2) It is not negligent for a doctor to depart from the existing range of accepted
medical treatments for a condition if the decision to do so is taken responsibly.
(3) For the purposes of taking a responsible decision to depart from the existing
range of accepted medical treatments for a condition, the doctor must in
particular—
(a) obtain the views of one or more appropriately qualified doctors in
relation to the proposed treatment,
(b) take full account of the views obtained under paragraph (a) (and do so
in a way in which any responsible doctor would be expected to take
account of such views),
(c) obtain any consents required by law to the carrying out of the proposed
treatment,
(d) consider—
(i) any opinions or requests expressed by or in relation to the
patient,
(ii) the risks and benefits that are, or can reasonably be expected to
be, associated with the proposed treatment, the treatments that
fall within the existing range of accepted medical treatments for
the condition, and not carrying out any of those treatments, and
(iii) any other matter that it is necessary for the doctor to consider in
order to reach a clinical judgement, and
(e) take such other steps as are necessary to secure that the decision is
made in a way which is accountable and transparent.
For the purposes of subsection (3)(a), a doctor is appropriately qualified if he
or she has appropriate expertise and experience in dealing with patients with
the condition in question.
(5) Nothing in this section permits a doctor to carry out treatment for the purposes
of research or for any purpose other than the best interests of the patient.
(6) In this Act—
(a) “doctor” means a registered medical practitioner;
(b) a reference to treatment of a condition includes a reference to its
management (and a reference to treatment includes inaction).
2 Effect on existing law
(1) Nothing in section 1 affects any rule of the common law to the effect that a
departure from the existing range of accepted medical treatments for a
condition is not negligent if supported by a responsible body of medical
opinion.
(2) Accordingly—
(a) where a doctor departs from the existing range of accepted medical
treatments for a condition, it is for the doctor to decide whether to do
so in accordance with section 1 or in reliance on any rule of the common
law referred to in subsection (1);
(b) a departure from the existing range of accepted medical treatments for
a condition is not negligent merely because the decision to depart from
that range of treatments was taken otherwise than in accordance with
section 1.
The anti-Saatchi bill campaign should explain why this bill is apparently a "quack's charter" rather than keep repeating their empty claims. This issue is too important to be submerged under a tide of unhelpful rhetoric. 

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