Monday, July 08, 2019 7:47:16 AM
As discussed many times here by Xena and others...maybe this will break the cycle. The lack of credibility here is a "SHOCK" to many who keep a childlike faith that the system must be right.
https://endpts.com/top-alzheimers-researcher-paul-aisen-apologizes-for-ethics-integrity-breach-as-usc-pays-50m-to-settle-poaching-lawsuit/
It's easy to fill in a few blanks. Japanese quality professionals have a well established practice known as "5 WHY's". Simply continue to ask the "why" question to get to a solution. It is effective. Had anyone even done that simple process here we all would have saved time, which is the most important element lost by patients.
Now my question is...WHY didn't the FDA do a similar exercise w/those people and processes in use? Are they still in use? WHY?
https://endpts.com/top-alzheimers-researcher-paul-aisen-apologizes-for-ethics-integrity-breach-as-usc-pays-50m-to-settle-poaching-lawsuit/
In addition to being a professor at UCSD, Aisen was named director of the Alzheimer’s Disease Cooperative Study back in 2007. The ADCS is a research consortium that plays a key role in undertaking large Alzheimer’s drug studies. Aisen has done considerable work advising Eli Lilly on its late-stage drug solanezumab, at one point reportedly playing a key role in persuading Lilly to take the drug back into Phase III — where it failed.
It's easy to fill in a few blanks. Japanese quality professionals have a well established practice known as "5 WHY's". Simply continue to ask the "why" question to get to a solution. It is effective. Had anyone even done that simple process here we all would have saved time, which is the most important element lost by patients.
Now my question is...WHY didn't the FDA do a similar exercise w/those people and processes in use? Are they still in use? WHY?
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