Indeed, Saving One Life is Important. Yet, Important Too is Saving Many Lives
The Risk Vs. The Reward
We keep repeating that the CAR-T treatment is created to stay, not because somebody loves the firms developing the CAR-T immunotherapy, but because this novel approach to cancer is saving the lives of the condemned. In addition, many reasons exist that make oncologists and regulators believe that the treatment will be perfected and will save more lives than any statistics’ past history would tell.
The question is not about one death, but about how many condemned late stage cancer patients have been given hope, or saved after all other treatments, marketed and investigational have failed.
Indeed, the FDA will be involved, trying to pinpoint the cause, or causes of the one death from among 300 people who were treated with Kite’s (KITE) CAR-T approach. The FDA, the NIH, the academic oncology centers in the top universities in the world will be also looking into the death case. They will do, not to stop the product, not to deny approving it, but as part of their attempts to find a way to improve CAR-T safety, in addition to its efficacy. These attempts are ongoing and we wrote several articles about them and about the academic institutions’ collaboration with the developing firms in order to prevent the occurrence of the cytokine release syndrome and also to enable the CAR-T to be effective in treating solid tumors in addition to hematologic malignancies.
The regulatory agencies along with top research institutions, universities and serious drug developers – all recognize the value of every human life. They all do whatever they can to prevent loss of life. Unfortunately, some cancer cases are so advanced that the best existing treatments might not work as they do in other advanced stage cancers. Also, the people with very advanced cancer who took several treatments might not be tolerate to tolerate their adverse effects. All cancer treatments have numerous adverse effects with some extremely toxic, however, when the rewards outweigh the risk the products are approved for marketing.
To be continued…
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