I think Larry Allen pretty much summed up the current state of failure of the modern medical practices right there..
Lets say we discover a yet- undiscovered tribe deep in the amazon, that are using clay that they source from a river as some kind of medical treatment. They eat it when they are feeling sick to feel better, they rub it on sore's to prevent infection.
Medical company A comes along and observes..... because that is really all medicine or anything else is really.... observe and look for patterns.
Yes, they appear to feel better if they eat clay after feeling bad.... yes their cuts and bruises never get infected even though they have open wounds in the jungle.... the clay must be the answer.
Modern medicine then requires that company to formulate the exact mechanism of action of the clay, and then design trials that basically pinpoints the exact or only stated benefit of the treatment. the more benefits the treatment has, the harder it is to prove because modern medicine then demands something like....
If you say it reduces stomach aches.... then all you need to show is a 15 % benefit and we will approve.
If you say it reduces stomach aches and stops sores from getting infected, the so long as one shows a 45% benefit then we will approve.
If you say it reduces stomach aches, stops sores from getting infected and also stops diarrhea ..... you must show an 80 % improvement.
If you say it reduces stomach aches, stops sores from getting infected, stops diarrhea, and prevents heart attacks... for any approval you now need a 98% improvement overbaseline for one of the indications.
The problem is......pharma companies often don't exactly understand the MOA, or the exact benefit, because it is not in mainstream use and they don't have millions of case examples worth of data... The other issue is, is that if it did indeed cur 97 % of heart attacks in the last example, they will not approve it due to multiplicity...... yet had they selected heart attacks as the primary end points, then they would only need to show a measly 15% improvement.
This is the dilemma MSB have been dealing with now as they get into the final stages of the phase 3 trials, and unfortunately - as MSB stated.... the FDA are the ones who have been setting and suggesting some of these end points, that have turned out to be the wrong choice..... while some of the more serious " gold standard" end points for efficacy were left as secondary but had tremendous results.
Take it one step further.... and say that you join the tribe, you've been bitten by a venomous snake, and the village doctors tells you the poison will eat your insides and within 2 years you will die from CHF. He then says he has some of the clay that a group of 500 of the villagers took in a placebo controll randomised trial, that was supposed to reduce hospital visits, but instead it appears there was a huge decrease in stroke, heart attack, and the death rate was 50% of the control group death rate.
You then say.... I'm not taking that as it doesn't reduce hospitalizations..... there is no clear medical message from that trial because I have to ignore all the other facts that occurred.... because they said it should help reduce hospitalizations...
It's like, if aliens visited earth and gave us a cup from the fountain of youth and then said this will make you live longer.
Medical company A then runs a medical trial with 50,000 humans in it for 100 years, and sets the primary end point of humans living longer.
They then discover that actually, nobody lived longer, there was virtually no difference at all in the ages that they died at.
but
All the people that died seemed to have the physique, stamina, strength, endurance, flexibility of a 20 year old at the age of 90,as if the aging process had been halted entirely.
Sorry...... multiplicity means the human race will need to wait for another 100 years, ignore the results from the 50,000 person trial because that was not the primary end point.
Not having a go at Larry, he is just another pawn in the system......
Isn't it medieval?....... particularly when the side effect is a big reduction in death without side effects.......... stuff em... let them die an run another trial modern medicine says.....
Expand
(20min delay)