Question on the CAR-T example, what about cross over examinations as opposed to RCTs?? CAR-Ts are in most cases 4th and 5th line treatments, it would be very interesting to see the results in patients receiving this 1st line or 2nd line (CARVYKTI was recently approved for 2nd line). Also, more of a political question, but insertional mutagenesis has always been a concern-albeit slight-for gene therapies, why did the FDA wait so long to ask these questions? Many of these drugs were recently commercialized at the time of this finding, they had been in clinical for years…
All good points to consider in systematic reviews as well as its ne'er-do-well cousin---meta-analysis. But the elephant in the room for all medical studies is the validity of the data. Without that, the rest is academic. The poster child for inaccurate data are the studies on covid. They should all be thrown out because the quality of the data is terrible. All statistics on covid depend upon "tests" that actually test nothing of significance (PCR) and antibody determinations that are known to be confounded by cross reaction. These brought us the ridiculous concept of asymptomatic infections known as "cases" for a disease that was defined as a symptom complex virtually indistinguishable from common colds and flu. The blatant corruption of doctors and hospitals labelling deaths due to accident or other medical causes as "covid" is just icing on the cake.
Question on the CAR-T example, what about cross over examinations as opposed to RCTs?? CAR-Ts are in most cases 4th and 5th line treatments, it would be very interesting to see the results in patients receiving this 1st line or 2nd line (CARVYKTI was recently approved for 2nd line). Also, more of a political question, but insertional mutagenesis has always been a concern-albeit slight-for gene therapies, why did the FDA wait so long to ask these questions? Many of these drugs were recently commercialized at the time of this finding, they had been in clinical for years…
Please just give me the text. Not 10 steps to try to get text from substack, which keeps trying to sell me stuff I don't want.
All good points to consider in systematic reviews as well as its ne'er-do-well cousin---meta-analysis. But the elephant in the room for all medical studies is the validity of the data. Without that, the rest is academic. The poster child for inaccurate data are the studies on covid. They should all be thrown out because the quality of the data is terrible. All statistics on covid depend upon "tests" that actually test nothing of significance (PCR) and antibody determinations that are known to be confounded by cross reaction. These brought us the ridiculous concept of asymptomatic infections known as "cases" for a disease that was defined as a symptom complex virtually indistinguishable from common colds and flu. The blatant corruption of doctors and hospitals labelling deaths due to accident or other medical causes as "covid" is just icing on the cake.
Surely
Someone
Somewhere
Learned
Something
Valuable
In Medical School.
Or Am I Wrong ?
Yes