bencro wrote: Once again, our fearmonger-in-chief Bionicjoke is trying hard, one more time. But once again, only shows his incompetency.
After looking goofy on the patent topic on 3 occassions (via his previous aliases), he goofs again on this one.
If our clown would have had any perspectives and any serious knowledge about clinical trials and adverse event definitions, he would not have posted the word "
complications". But we know he tries to create a "doubt", like always.
So lets see what our clown intentionally omits:
#1) These are sick patients. Not healthy subjects.
In clinical trials, even in healthy subjects, you have mild to moderate adverse events. In all trials. Just imagine with unhealthy patients.
#2) Our clown doesn't make a distinction between
adverse events and
serious adverse events. Low dose patients
did NOT experience any
serious adverse events. Welcome to Online Training for Clinical Research Coordinators
Adverse Events in Clinical Trials: Definitions and Documentation Objectives: Recognize the difference between a non-serious adverse event and Serious Adverse Events (SAEs).
Source:
https://hub.ucsf.edu/sites/hub.ucsf.edu/files/6.%20Adverse%20Eventsd%20Definitions.pdf #3) Examples of Grading Severity/Intensity Ranges
•
Grade 1:
Asymptomatic or
mild symptoms; clinical or diagnostic observations only;
no intervention indicated •
Grade 2:
Moderate;
minimal, local or noninvasive intervention • indicated; limiting age-appropriate instrumental ADL •
•
Grade 3:
Severe; or medically significant but not immediately lifethreatening; hospitalization or prolongation of
hospitalization indicated; disabling; limiting self care ADL
•
Grade 4:
Life-threatening ; urgent intervention indicated.
•
Grade 5:
Death related to an AE
#4) Compared to
chemo and auto-immune drugs, where
treatments are spanned over many months that, over the long run, impact other organs (like kidneys, liver, etc ...),
TLT's technology is a one shot treatment. That makes a huge difference.
#5) JUNO had 5 deaths in 2 of his clinical trials and is still worth 2.5G$ and FDA still continues to support its drug.
#6) KEYTRUDA ... Yet approved, take a look at just some examples of its
serious adverse events list ... KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. ...
Serious adverse reactions occurred in
39% of KEYTRUDA-treated patients
We could go on and on ... Source:
KEYTRUDA® | Information for Health Care Professionals #7) Chemo impacts your white cells counts (that why chemo related patients often die of infections) and has so many other impacts on other organs and yet, it is still approved.