Saturday, August 15, 2009

Ethical conundrums?

Para 4.1.4 of the Singapore Medical Council Ethical Code and Ethical Guidelines states very explicitly: "A doctor shall treat patients according to generally accepted methods and use only licensed drugs for appropriate indications. A doctor shall not offer to patients, management plans or remedies that are not generally accepted by the profession, except in the context of a formal and approved clinical trial."

Two clinical situations appear to violate this principle:

a] The use of a medicine for an indication that has not been approved by the Health Sciences Authority (HSA). All medicines marketed in Singapore are licensed only according to approved indications. In any other situations, these would be considered 'off-label' use. In most cases, these indications have not been approved because no clinical trials have been done for these indications and therefore there is no proof of their clinical efficacy, and importantly, there is no evidence of their safety. However, doctors very often use these medicines for indications outside approved indications even if no evidence exists of their safety and efficacy. Technically, these doctors using drugs in an 'off-label' capacity would not be treating patients according to generally accepted methods, and are not using drugs for appropriate indications. And as these treatments are most often not offered in the context of a clinical trial, their use would place these doctors in violation of Para 4.1.4.

b] New surgical procedures. Surgical procedures, unlike, new drugs do not require to be clinical trialed before they are applied in the operating theatre. Hence, there is actually no proof of efficacy or risks. Surgeons remain quite free to offer anything they come up with, and can make fanciful claims of success without need to show proof of their claims. Too what extent are these 'new procedures' a remedy 'generally accepted by the medical profession'? It is hard to tell. The Singapore Medical Council generally looks the other way when it comes to doctors making outlandish claims about such new therapies.

The question I have is why publish guidelines such as Para 4.1.4, when it is not the intention of the SMC to consider the above as violations?

Perhaps the patient public should raise a few complaints where these are concerned to prompt the SMC to review their guidelines.

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