"Correct me if I am wrong, but the placebo affect won’t impact the bio markers."
Hi Hrdwrk, I'm politely and of course humbly correcting you....
Yes I always incorrectly supposed that placebo would not be at all capable of influencing hard data, hard science such as biomarkers or the physical phenotypes, think Joint Width Space...BML growth, joint function and of course biomarkers. I'm totally wrong, it can.
HOW?
Magic?
Not quite.
The brain is a tricky thing....it gets at all convinced that it is having a drug that has a lot of efficacy or supposedly efficacy and numerous hormones, endorphins and millions of reactions can and do take place, it's been studied in great depth. These reactions can result in a PHYSICAL pathogenesis to some extent. Placebo effect is more pronounced in associated pain indications. This is the very reason why PAR must be very sensitive around what they promote, what data they announce and how the announce it, particularly at the sensitive time of recruitment of placebo groups as part of studies and trials.
It is at these very times you wont generally be finding a whole heap of marketing/advertising and pronouncement of data, my views. If I were a prospective patient thinking seriously of enrolling myself into 008 or 002...I would do at least some research before signing up:
What drug am I about to take?
How has it affected others?
What can I expect?
What is the degree and range of possibly good effects that I could expect?
What are the drawbacks?
What has the company begin observing just recently?
Maybe thats me but the average Jo Blo would at least look up something about the drug and the company at a general level and perhaps the last couple of announcements? It can do no harm if PAR treads a little cautiously at least for the first bit of potential recruitment, again my views.
Don't forget the placebo effect can be so crazily strong that patients WHO HAVE BEEN TOLD UP FRONT THAT THEY ARE GOING TO GET A PLACENO STILL can have a positive effect on their indication! There are studies that back this phenomena up, this is what we are up against.
Want and need a bit more evidence?
My emphasis in red below, reference is peer reviewed and pertains to a study in RA. 1
------------------ Question
Are subjective patient-reported outcomes vs objective biomarkers associated with higher placebo responses in clinical trials?
Findings
In this cross-sectional study examining the placebo arms of 5 randomized clinical trials of rheumatoid arthritis including 788 patients, objective markers of inflammation and subjective pain ratings improved in a comparable clinically meaningful magnitude. Baseline values were associated with placebo response, suggesting that regression to the mean might dominate response to randomized placebo treatment.
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One more example if I may, A famous story of a medico back in the war of 1919 a fellow by the name of Henry Breecher2:
"When Beecher found himself running out of pain killers while tending to U.S. soldiers on the Italian front, the story goes, he told the wounded soldiers that a saline-filled syringe held morphine. Many soldiers, thus deceived, were comforted."
There is a stack of evidence in the area of placebo and it's strong ability to result in positive physical effects. We are up against this phenomena. PAR and the chosen CRO's have mitigatory steps in place to try and reduce this as much as possible as part of the trial and study designs.
(20min delay)