marks just wrote an op-ed in one of the big journals about kennedy's reforms of ACIP and change on covid shot policy.
ultimately, marks was screeching they are not following the science when it comes to covid jabs + new ACIP committee members threaten the 'gold standard' reputation of the fda.
however under marks - he forced the resignations of krause & gruber - 2 MD's with decades more experience than marks had at FDA because they wouldn't toe the biden admin line and push boosters on the healthy usa population. this came out in testimony given by Philip Krause in 2024 - i think rand paul was questioning him:
"In a 7/19/21 meeting memorialized in a 7/21/21 memo by Dr. Gruber, Drs. Woodcock and
Marks relieved Dr. Gruber and me of responsibility for managing the ongoing BLA review and
placed Dr. Marks in charge."
per marks' claim of gold standard science - have you read the expose published at the lever written by Jeanne Lenzer & Shannon Brownlee about a 9 year review of 400 fda 'approved' drugs/biologics called: FDA Approved — And Ineffective?
Yes, that was clear from the start - great comment! - and Janet Woodcock, who had a long career as Director of CDER and was pushed to interim commissioner before retiring - would have been under the empty shirt Califf: https://en.wikipedia.org/wiki/Robert_Califf and Marks' dictat.
Today, there is still a feeding frenzy for 'biotechs', especially in silicon valley who are pushing new mRNA cocktails where the fundamentals don't exist. It is a bubble. The great American gold rush went pop, the dot.com bubble exploded, and so will this...
"Effective and insightful solutions to the most pressing supply chain challenges facing pharmaceutical companies today
In Transforming the Pharmaceutical Supply Chain, veteran biotech supply chain strategist, Hedley Rees, delivers a reasoned and systematic solution to the most widespread and relevant challenges in the pharmaceutical supply chain. The book explains the deeply rooted issues within pharma supply chains and the modus operandi of the industry while also discussing effective solutions to the underlying causes that led to widespread system breakdown."
The book will set the record straight, albeit it is for a very specific pharmaceutical audience, hence not cheap...
marks just wrote an op-ed in one of the big journals about kennedy's reforms of ACIP and change on covid shot policy.
ultimately, marks was screeching they are not following the science when it comes to covid jabs + new ACIP committee members threaten the 'gold standard' reputation of the fda.
however under marks - he forced the resignations of krause & gruber - 2 MD's with decades more experience than marks had at FDA because they wouldn't toe the biden admin line and push boosters on the healthy usa population. this came out in testimony given by Philip Krause in 2024 - i think rand paul was questioning him:
transcript of testimony: https://docs.house.gov/meetings/JU/JU05/20240626/117456/HHRG-118-JU05-Wstate-KrauseMDP-20240626.pdf
notably:
"In a 7/19/21 meeting memorialized in a 7/21/21 memo by Dr. Gruber, Drs. Woodcock and
Marks relieved Dr. Gruber and me of responsibility for managing the ongoing BLA review and
placed Dr. Marks in charge."
per marks' claim of gold standard science - have you read the expose published at the lever written by Jeanne Lenzer & Shannon Brownlee about a 9 year review of 400 fda 'approved' drugs/biologics called: FDA Approved — And Ineffective?
https://www.levernews.com/fda-approved-and-ineffective/
73% of drugs approved by the FDA during that time failed to meet all four basic criteria for demonstrating “substantial evidence” of effectiveness.
112 products met all 4 criteria, 40 met none of the criteria
Yes, that was clear from the start - great comment! - and Janet Woodcock, who had a long career as Director of CDER and was pushed to interim commissioner before retiring - would have been under the empty shirt Califf: https://en.wikipedia.org/wiki/Robert_Califf and Marks' dictat.
Today, there is still a feeding frenzy for 'biotechs', especially in silicon valley who are pushing new mRNA cocktails where the fundamentals don't exist. It is a bubble. The great American gold rush went pop, the dot.com bubble exploded, and so will this...
The FDA is inspecting their manufacturing establishments and putting studies on hold, see: FDA hits Unicycive with manufacturing-related complete response letter, delaying hopes for kidney disease prospect, link: https://www.fiercepharma.com/manufacturing/fda-hits-unicycive-manufacturing-related-complete-response-letter-delaying-hopes
Return to normal service will be resumed as soon as possible (Gold Standard FDA is back).
Thank you for reporting, and also explaining, dear Hedley! Yours is a very valuable voice!
Thanks Reader. Your suggestion that I keep all emails free has got the word out further and wider!....grateful to you for that :)
So glad! People really need to hear what you have to say!!
This will be published by Wiley on September 17th:
https://www.wiley.com/en-us/Transforming+the+Pharmaceutical+Supply+Chain-p-9781394244126
Wiley's words, not mine:
"Effective and insightful solutions to the most pressing supply chain challenges facing pharmaceutical companies today
In Transforming the Pharmaceutical Supply Chain, veteran biotech supply chain strategist, Hedley Rees, delivers a reasoned and systematic solution to the most widespread and relevant challenges in the pharmaceutical supply chain. The book explains the deeply rooted issues within pharma supply chains and the modus operandi of the industry while also discussing effective solutions to the underlying causes that led to widespread system breakdown."
The book will set the record straight, albeit it is for a very specific pharmaceutical audience, hence not cheap...