Drug Trials?

Posted by on in From, Jim

The criteria for the FDA to approve a new anti-epileptic drug is merely that a medication must reduce seizures by 50% in 50% of the people who don’t drop out of the trial because of intolerance, non compliance, adverse affects, or other reasons.  So lets crunch the numbers.  Let’s say a new drug is tested on 100 people.  Of that number lets say 20 people drop out of the study for whatever reason.  That means that for the drug to get FDA approval there has to be seizure reduction of at least 50% in only 40 of the original 100 people who started the trial.  There is no requirement for anything more than 50% reduction.

Compare that to Ketogenic  Diets.    For ninety plus years 66% of the people who try them, including those who stop because of non-compliance, adverse affects, etc.  have seizure reduction of greater than 50% -- not to mention fewer drugs, improved cognition, and seizure freedom.  In other words, of 100 new people who try a ketogenic therapy, 66 will improve. 

That’s right.  75% better outcomes with ketogenic therapies than the next drug the FDA can approve.

Maybe that's why our logo has a smile!

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  • Guest
    Doug Krause Thursday, 18 June 2015

    One other piece of drug company trickery is that they screen the trial participants typically for 30 days or so to gauge their tolerance to the drug BEFORE the trial even begins. So, any participants within that pre-trial period are eliminated from the study, think about that one for a while and then keep it in mind for every prescription drug you are considering subjecting yourself or a loved one to...

  • Guest
    Jim Abrahams Thursday, 18 June 2015

    Even after stacking the deck like this, according to a study published in the New England Journal of Medicine, 47% of newly diagnosed epilepsy patients experience seizure control with the first medication, 13% with the second drug, and 1% with the third. You can see the whole chart on the home page of The Charlie Foundation website.

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Guest Thursday, 30 July 2015