Is there really a need for the "Medical Innovation Bill"? Part II
I will deal with the second objection to the Medical Innovation Bill now.
The bill will allow quackery - we should only be practising evidence-based medicine
There are a lot of safeguards for people who participate in clinical research. This is entirely appropriate, as the hallmark of research (as opposed to innovation) is that the primary purpose is gaining knowledge. The patient in a clinical trial typically gets standard care plus a placebo OR the intervention being studied.
The patient receiving innovative care is not subjected to the placebo lottery. On the other hand, no comparisons can be made between the intervention and no intervention. One of the provisions of the bill will be a data gathering requirement. Currently, there is no systematic collection of evidence from innovative practice.
Many treatments go through a stage when they are an innovation. Most new surgical treatments are an innovation.There are very few trials comparing surgery with sham surgery, largely because this would be unethical in most cases. Drugs may already be used on a compassionate basis, where the condition is terminal and there are no treatments available.
The bill would not herald a wave of non-evidence based treatments. The proponents of Evidence-Based Medicine must acknowledge two issues: 1) there is little or no evidence for the treatment of some conditions and 2) patient autonomy should not be overridden by a slavish adherence to the principles of evidence-based medicine. The bill clearly would not apply where there are evidence-based treatments.
Neither would it herald a wave of quackery. There would need to be a process of consultation, fully informed consent, a plausible mechanism, and the best interest of the patient would be paramount.
The use of innovation is certainly not contrary to the principles of evidence-based medicine.
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