Storm in a Car-T-Cup29 Nov 2023 10:07
Whilst i understand that seeing a headline like we did yesterday may cause some initial panic (suggest you check out what happened to CAR-T stocks in the US - they plummeted initially before recovering back to where they started once investors properly did their due diligence)
Our resident trolls don't do their due diligence - they simply latch on to a headline that they think may cause some FUD
Prevail do due diligence - they are the master of Biotech due diligence - reflect on that...
Some facts:
- CAR-T cell therapy has revolutionised the treatment of several blood cancers that once had no appropriate treatment options.
- CAR-T is very new - only 5 approved by FDA so far but many more in the pipeline and CAR-T has further to go to achieve global reach
- 'Tens of thousands' patients have had CAR-T therapy so far
- FDA have reported over ~7,000 where patients have suffered serious side effects after having CAR-T. (Quick IMO intervention - I think this is quite high and represents as much as 1:5 patients). However, those who are treated with CAR-T are seriously ill and have minimal or no other viable options to improve their outcome.
- Of these 7000 serious cases - only 12 of them due to T-cell malignancies. (That's just 0.1% of serious side effects and less than 0.05% and less than 1 person per 10000 who have been treated with CAR-T)
- As JHFH as posted - this issue was raise by the CAR-T pioneer Dr Carl June over 5 years ago. Since then a number of safeguards have been put in place to address
- Patients who are benefiting and will benefit hopefully one day from Hemo CAR-T are seriously ill and have little or no clinical options remaining to them.
- All drugs and therapies have serious side effects; however, FDA will only approve drugs and therapies where the chances of serious side effects are low
Some opinion and conclusions
All drugs and therapies have common (and rare) side effects - the ones i take every day could cause:
constant headaches, long-lasting confusion, weakness, or frequent muscle cramps, , a feeling of restlessness that means you cannot sit or stand still, unexplained muscle pain or weakness, whites of eyes or skin turn yellow,; a sign of liver problems, changes in eyesight, like blurred vision or dilated pupils, bleeding in the stomach, bleeding from the gums, or bruises may appear without a reason or that get bigger , shortness of breath, or a fast or irregular heart beat
and finally thoughts about harming yourself or ending your life
CAR-T therapy is very new - they have been approved based on only a few years to test long term effects.
It is the FDA job to protect patients - It is right that they ensure that longer term tests are tracked an reported to protect patients.
As the scientific world learns more, CAR-T will only get safer and go on to save more patients.
BTW - One very tasty stat i found - one of the Pharma who have an approved CAR-T generated over $1billion in
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