Experimental drugs/therapies

Dingle_berry

Scientific literature is full of experimental or putative new drugs or therapies. Some better characterised than others. Some licensed for use in certain circumstances only but nothing preventing them for working in all circumstances of the same condition.
So how is it decided how a drug or therapy can be used? Does the IMB have sole discretion over what can be prescribed? Can a clinician or patient request experimental therapies? (Outside a clinical trial?)

For example Sipuleucel-T as a last chance for prostate cancer. Could an Irish patient receive this? Could a patient with low grade PAP positive cancer get it? What if a patient with HER2 positive cancer wanted to try a HER2 version and sourced a manufacturer of it? Could an oncologist etc source and administer a HER2 version of Sipuleucel-T?

echo beach

Dingle_berry wrote: »

So how is it decided how a drug or therapy can be used? Does the IMB have sole discretion over what can be prescribed? Can a clinician or patient request experimental therapies? (Outside a clinical trial?)

My understanding of the IMB's role is that they licence drugs for use in certain conditions based on the evidence presented to them. Doctors can prescribe these drugs for other conditions or in different dosage regimes and this is termed 'off label' use. They can also prescribe drugs that don't have a licence from the IMB, unlicensed medicines, but must take professional responsibility for that decision. Many unlicensed medicines are licensed in other countries or are widely used with a strong evidence base so this usually isn't a problem. For experimental drugs with no evidence of benefits or potential dangers, using them outside of a clinical trail could be considered unethical and might not be covered by professional liability insurance so many doctors would be reluctant to get involved with their use.
A recent inquest which raised concerns about the 'off label' use of misoprostol to induce labour shows the problems that can arise when things go wrong even with an established therapy.