Re: Withdraw Saatchi’s quackery bill
I do not believe that Dr McCartney has ‘misunderstood the fundamental purpose of this bill’ as this ‘purpose’ appears to be highly misconceived and ever-shifting.
Professor Kennedy states the Bill ‘seeks to offer patients hope when the evidence base is either lacking or uncertain.’ .. ‘to make ‘quackery’ more, not less, difficult to practise than at present.’ despite removing for example, fundamental requirements for approval (first do no harm?)
This, as a reader, is highly troubling and flawed logic: I wonder if we were reading the same Bill? With an evidence base lacking and uncertain, surely we should not be offering false hope and assurance to the most desperate of patients? Surely this is coercing them into treatment? In fact, this is research, with no evidence basis or logic to back it required nor the approval of an REC.
Mr Chan’s response to this article is coherent yet has clearly been formulated with significant input from consultation responses. I shall therefore not refer to clauses from the original Bill as it would still appear the goalpost is ever-shifting. It does however make it clear that the intent of the Bill is, as all press coverage has stated, to progress research and ‘cure cancer’. The categorisation of safeguarding the patient with scientific advancement is a peculiar paradox in justifying the legislation.
Chan refers to a dearth of clinical trials. If this is the case in rare presentations, surely this needs prioritisation of funding and access and should be the main focus of any efforts to make a real improvement and advancement to the future? Secondly, there are many multicentre studies and RCTs ongoing where data can be collected and shared via a research network, e.g. SPLIT registry publishes many multinational multicentre trials. It is these trials that yield important data: these multinational trial networks are an optimal way to increase our evidence base significantly in rare diseases, especially, I would argue, in paediatrics, a field where so many drugs are used off-label by necessity at present.
A ‘Central Data Repository’ was entirely absent from the Bill, which for a second draft and a large development team is extraordinary. It was the first thing I noticed and this logic is widely echoed by those much more experienced than myself. However it is still at odds with some fundamental issues for the individual patient. To use it ‘for generating novel hypotheses for new studies also concerns me, indicating the experimental approach on the patient pre-hypothesis?
These are people, cancer, illness, or not and treatment should be strictly on a risk:benefit basis. To allow anything other than this is a terrifying leap back into history. Furthermore this proposal is already current practice after a reasonable innovative decision confirms treatment may be successful. Nothing new is added by legislation. If there is some logical reasoning behind a novel treatment without RCT for a rare disease, it would be found to be responsible even if the opinion was not shared by a majority.
Failure to report findings is widely regarded as misconduct. Again, this Bill is not required.
Perhaps now this Bill might 'restore the pendulum into its rightful position', where the current law works appropriately, patients are safeguarded, approvals are thorough and the correct balance is struck between evidence based medicine and responsible innovation: which, by definition, is not negligence.
Any progress to be made would be in funding research or development of better international data analysis and networking of trial results to enable the most rapid best practice decisions to be made.
There is no empirical evidence of any basis for this Bill. Legislation will hinder innovation which is currently permitted under law. Is this now the new goal? If so the name of the Bill requires radical change and all former rationale redacting. The law also currently provides safeguards even against accepted standard treatments when they are found to be lacking (AB v Leeds, NHS Trust v J). Chan states on Dr McCartney’s blog that colleagues before evidence based medicine formed a ‘logical plan using knowledge.. This is exactly what our law says is responsible treatment (Bolitho, Simms) The law protects both patients and doctors.
Quoting ‘’personalised medicine’’ to interpret molecular change in the patient is surely both an example of metabolomics genetic and technical advances that can be used to make ‘responsible, logical’ decisions about treatment, and a nod to the importance of patient-centredness and casuistry. The law is individualised in approach, allowing radical treatments without evidence base where it is appropriate - a heavy handed unnecessary statute would not allow for this progress, patient-centredness, real-time innovation at all.
Finally, to state patients are fighting ‘the sands of time’ and use dramatic, coercive and emotive language: ‘contributing to the greater good’; ‘We, as their advocates, owe them a duty to innovate in a responsible manner. Otherwise, we condemn all these poor souls to the worse outcome possible – premature death. is both highly inappropriate in the context of legislative reform and, again, muddled and self-contradictory. We do ‘innovate in a responsible manner’ at present. The law fully protects and supports this as do the BMA, GMC, EMA and others.
Once again, there is no legal basis for any legislation. It would drive a pickaxe through decades of progress, contravening EU and national Directives, would impede innovation in clinical practice for the responsible doctor while protecting the irresponsible by adding spurious vague reference to an MDT. It would destroy years of progress in research standards, and pharmaceutical law and transport us back to pre-Helsinki. Furthermore it would likely increase litigation rates and fail to add to any evidence base. It would enable use of treatments that have no logical basis whatsoever, and remove accountability.
This is so thoroughly inappropriate I suggest the Bill team revert with an alternative personal catharsis for Lord Saatchi. With any hope, a fund or investment in network/global trials access would help to further advancement and care. This Bill should have a survival rate of zero.
Competing interests: No competing interests