Tuesday, March 24, 2020

Understand WHY Complete Drug Testing Is Mandatory!

"At a Thursday news briefing, Trump trumpeted that chloroquine had shown 'very, very encouraging early results' and said 'we’re going to be able to make that drug available almost immediately.' Minutes later, FDA Commissioner Stephen Hahn, an oncologist, clarified that the drug would be available 'in the setting of a clinical trial — a large, pragmatic clinical trial — to actually gather that information and answer the question that needs to be answered and — asked and answered.'

"Friday, the President said, 'It may work, it may not work. I feel good about it. That’s all it is. Just a feeling.' At the same press conference, Anthony Fauci, a physician who heads the NIAID and a veteran of outbreaks going back to HIV, emphasized the need for a methodical clinical trial."

Thanks to Trump, and quacks like Dr. Oz (link to his latest action) and many other magical thinkers, people are dying from hydroxychloroquine, a valid antimalaria drug, in efforts to avoid the coronavirus effects. Below are the steps ALL drugs MUST go through before approval for a particular disease:
  • Phase 1 studies (typically involve 20 to 80 people). Phase 2 studies (typically involve a few dozen to about 300 people). Phase 3 studies (typically involve several hundred to about 3,000 people).
"The study referenced by Trump, and other studies done so far of potential treatments for Covid-19, are small and hastily designed even by the standards of Phase 1 studies. So how often do infectious-disease drugs that enter Phase 2 studies reach the market? An analysis by the Biotechnology Industry Organization says they worked out only 27.5% of the time between 2009 and 2015. That means that three-quarters of the time, medicines against infectious disease that looked promising in small studies either were ineffective or had side effects that made them unusable. Even for medicines that reached Phase 3 trials, just 63% succeeded."
Why President Trump is at odds with his medical experts over using malaria drugs against Covid-19


No comments:

Post a Comment

Labels


Click on image

Choose how you look at reality wisely. Yes, it is a binary choice.

Choose how you look at reality wisely. Yes, it is a binary choice.
Click on image