From my understanding of the situation, if DCVax-L is licenced by the MHRA (and the auguries for this are good) it is highly likely that NICE will rapidly endorse it for use in the NHS as its price will be significantly less than current cancer therapies, something that Mrs Powers has already indicated publicly (and was referred to in a Message on this board within the last week) .
Once DCVax-L is in use in the NHS, there is no legal reason to prevent a competent doctor from adding in poly-ICLC to the DCVax-L treatment even though the poly-ICLC, by itself or in combination, has not been formally tested in a clinical trial for GBM, is not licenced by the MHRA and is not endorsed by NICE. Of course there are provisos for going off-licence: 1] the NHS would not pay for the poly-ICLC (but a 2 week course might be anywhere between $500 - $2,000 [ChatGPT]); 2] the Doctor would have to take full responsibility for what he is doing and would have to satisfy several conditions or run the risk of a penalty, up to and including manslaughter and/or striking off should he be found to have disregarded the guidelines or acted recklessly. This will be adjudged by whether he was acting in line with the following [ChatGPT]:
1] Clinical Justification: The prescriber must have a strong clinical justification for using an unlicensed medication. This typically occurs when no licensed alternative is available or when the licensed alternatives have been ineffective or unsuitable for the patient.
2] Informed Consent: The patient (or their legal guardian) must be fully informed about the unlicensed status of the medication, the reasons for its use, potential risks, and any available alternatives. Informed consent should be obtained and documented.
3] Professional Responsibility: The prescribing clinician assumes full responsibility for the decision to use an unlicensed medication and its outcomes. They must ensure that they are acting in the patient’s best interest and that they have sufficient knowledge about the medication and its effects.
4] Guidance and Recommendations: Organizations such as the General Medical Council (GMC) and the British Medical Association (BMA) provide guidelines on the circumstances and conditions under which unlicensed medications can be prescribed. These guidelines emphasize patient safety, thorough documentation, and clinical necessity .
5] Special Situations: Unlicensed prescribing is more common in certain fields such as pediatrics, oncology, and rare diseases where licensed treatments may not exist or are insufficient.
6] Regulatory Framework: While the MHRA oversees the licensing of medications, it also acknowledges that off-label and unlicensed prescribing can be essential in clinical practice. Therefore, it provides a regulatory framework within which such prescribing is permissible under the aforementioned conditions. [end ChatGPT]
If physicians see from the preliminary studies already done that poly-ICLC significantly boosts the efficacy of DCVax-L with little or no increase in toxicity and that it is within a reasonable price range for their patients (who will not now have to fund the whole of their DCVax-L treatment), it will soon become blindingly apparent that the combination is a highly effective treatment for GBM. The MHRA will then be hard pressed not to give it their (perhaps temporary and conditional) blessing even if they demand that those treated form part of an open trial using the Phase 3 study (as per the NY Academy of Science Journal) as the "historic comparison" group.
AI
