Looking beyond the spin of Big Pharma PR. But encouraging gossip. Come in and confide, you know you want to! “I’ll publish right or wrong. Fools are my theme, let satire be my song.”
Email: jackfriday2011(at)hotmail.co.uk
Thursday, November 12, 2009
Antipsychotics and dementia: bad news
1 comment:
Anonymous
said...
This has been bad news ever since the approval of Zyprexa (olanzapine - Lilly).
You simply have to look at the US FDA reviews that are available at Drugs@fda.
In the original summary basis of approval package it's clear that Paul Leiber the division director of the FDA Neuropsych division was concerned about the high proportion of deaths in the small elderly population that was studied for psychosis related to dementia and he refused to approved Zyprexa for this population. In fact there is a back and forth between Dr. Leiber (since retired) and Bob Temple the Director of Medical Policy about the safety in this population. Leiber clearly was able to prevent approval in the elderly but he was unable to prevent off-label promotion.
Note Bob Temple has written articles and stated numerous times that FDA cannot not approve a drug based on off-label risks. This of course is entirely false and flies in the face of the legislative history of the Harris Kefauver Amendments of 1961 which required that drugs be safe and effective and which included that drugs not be approved if they would be used off-label and hadn't been shown to be safe with such use (e.g. thalidomide). This was also testified to before the US congress by former FDA commissioner David Kessler, M.D., J.D.
Bob Temple has been instrumental in causing other cases of mass death due to drugs as related by Wall Street Journal Reporter Alicia Mundy in her book Dispensing with the Truth and with other drugs including Seldane by consistently overriding reviewers concerns and by approving drugs in direct violation of the Food Drug and Cosmetics Act.
It's time for Congress and President Obama to enforce the law and prosecute not only drug company executives but also FDA officials for crimes.
1 comment:
This has been bad news ever since the approval of Zyprexa (olanzapine - Lilly).
You simply have to look at the US FDA reviews that are available at Drugs@fda.
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/)
In the original summary basis of approval package it's clear that Paul Leiber the division director of the FDA Neuropsych division was concerned about the high proportion of deaths in the small elderly population that was studied for psychosis related to dementia and he refused to approved Zyprexa for this population. In fact there is a back and forth between Dr. Leiber (since retired) and Bob Temple the Director of Medical Policy about the safety in this population. Leiber clearly was able to prevent approval in the elderly but he was unable to prevent off-label promotion.
Note Bob Temple has written articles and stated numerous times that FDA cannot not approve a drug based on off-label risks. This of course is entirely false and flies in the face of the legislative history of the Harris Kefauver Amendments of 1961 which required that drugs be safe and effective and which included that drugs not be approved if they would be used off-label and hadn't been shown to be safe with such use (e.g. thalidomide). This was also testified to before the US congress by former FDA commissioner David Kessler, M.D., J.D.
Bob Temple has been instrumental in causing other cases of mass death due to drugs as related by Wall Street Journal Reporter Alicia Mundy in her book Dispensing with the Truth and with other drugs including Seldane by consistently overriding reviewers concerns and by approving drugs in direct violation of the Food Drug and Cosmetics Act.
It's time for Congress and President Obama to enforce the law and prosecute not only drug company executives but also FDA officials for crimes.
The evidence is out there.
Post a Comment