The one USAtty whose firm is highly successful with FOiA requests to CDC and FDA is Aaron Siri. You may want to run your issue past Del Bigtree at the Highwire to see what he thinks.
I am an expert in biopharmaceutical supply chains – please see my resume attached.
Also, I have a long history as a campaigner for wholesale reform of Big Pharma, and am well known as an industry insider who speaks truth to power.
There is so much people don’t know about the supply chains for these vaccines. Quoting from my latest book – “Pharmaceutical supply chains produce the drugs that enter a patient's body. If anything goes wrong in production, even though the Regulatory Authority has approved a drug for sale, it can have a devastating impact.”
These are the things people don’t seem to know:
• None of the 4 vaccine ‘manufacturers’ developed or manufactured the vaccines themselves. None of the manufacturers have ever had a vaccine as part of their product portfolio, so they could be deemed as lacking sufficient experience to sponsor vaccine development and manufacture.
• For Pfizer/BioNTech and Moderna mRNA vaccines, Lonza manufacture the bulk drug substance and ship to Catalent Pharma Solutions for the fill/finish.
• For AZ/University of Oxford, Oxford BioMedica developed and manufacture the adenovirus bulk drug substance, and Wockhardt carryout fill/finish.
• For Janssen (J&J)’s adenovirus, it is the same contract manufacturers as Pfizer/BioNTech and Moderna.
• The manufacturers are legally responsible for the work of the contract manufacturing companies, according to CGMP, which is included in the US Code of Federal Regulations (CFR).
• FDA's portion of the CFR is in Title 21, which interprets the Federal Food, Drug and Cosmetic Act and related statutes, including the Public Health Service Act.
• The main elements of CGMP are: 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs. 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals. 21 CFR Part 600. Biological Products: General.
• In my expert view, it is physically impossible to develop vaccines on the timescales they have been, without contravening major elements of CGMP, such as process validation, audit of suppliers, change control, etc, etc.
I personally spent 6 months consulting at Oxford BioMedica on the Lentivirus vector used in Novartis’ Kymriah CAR T gene therapy treatment for blood cancers and there is no doubt the vaccines are gene therapy.
Please let me know if I could help further in any way.
Kind regards,
Hedley
Hedley Rees
Managing Consultant and Author
PharmaFlow Ltd
T: +44 1656 655664
M: +44 7734 961726
Book: Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics - Read Me
Book: Taming the BIG PHARMA MONSTER by Speaking Truth to Power – Read me
Book: What Patients Need to Know About Pharmaceutical Supply Chains – Read me
Subject: FW: Vaccine manufacturers have broken the law (FDA cGMP) relating to their supply chains
Hi Hedley,
Thank you for your email below. ICAN shared it with us. I’d like to potentially discuss ways in which you may be able to assist. For example, would you be willing, if needed, to provide a declaration laying out the facts that support your conclusion that it is impossible that all of the CGMP standards are being met? Please advise.
Subject: RE: Vaccine manufacturers have broken the law (FDA cGMP) relating to their supply chains
Hi Elizabeth,
Yes indeed – I would be happy to provide a declaration. I wrote to EMA 12 months ago about some of the issues and received a polite email back saying they were happy with everything!
Please do let me know what the format is for a declaration and anything else I need to know.
Kind regards,
Hedley
Following that communication in July 2021, I supplied Elizabeth Brehm with a substantial amount of information on how the SARS-CoV-2 injections must have been fraudulent. I was then asked to respond to this email:
Hi Hedley,
Wanted to run the attached complaint by you. Would love to know what you think about the allegations and claims (this is not a complaint I have been involved with at this point).
The defendants included Merck KGaA, Darmstadt, Germany (Merck KGaA), Sigma-Aldrich Corp and MilliporeSigm, and the case related to contravention of cGMP, especially contamination.
After supply all this information, and eventually Aaron Siri being patched into a Zoom call with Elizabeth Brehm and myself, nothing else happened.
When I complained, Elizabeth Brehm emailed to say "we didn't use any of your information".
I've had to become very philosophical to stay sane in what is happening in the world today!
Thanks for letting me get that off my chest Sherman :O)
Oh Noooo, did not expect to see this. They have a deep background into FOIAs, as they have done these so often. Most likely doesn't help that they've been busy since the rollout with around 40 attorneys on staff. More recently, Aaron has been called to different state's legislatures as well as the US Congress to testify. Changes are afoot. You may still want to consider contacting Del BigTree at ICAN to see what he thinks about a possible FOIA to get what you need. You never know looking under which rock, where the missing key is to stop the insanity.
:O) Yes Timothy, a very apt description. Not giving up though. There is a very interesting picture emerging on how the global scam was played, with some very prominent, yet undiscovered players revealed. It surpised me, that's for sure...more to come...
The only positive JAS is that there is more than enough visible to work out the scale of the non-compliances - but no action was taken. 13 observations on a Form 483 would have put shudders down the spine of plant managers 20 years ago...
Have you tried going to one of the congressional committees? Perhaps, send them the info you have and the responses you've received. The research was bought and paid for by taxpayers already.
Are you based in the US Geckogirl? Senate websites seem to want you to have an address with a US state? Anyway, this is the most relevant committee I think (HELP):
Hadn’t thought of that. Think the HELP Committee may be best? Only thing is I am not a US citizen, live in UK - any idea how I could get through to them? Thanks Geckogirl. Hedley :O)
The one USAtty whose firm is highly successful with FOiA requests to CDC and FDA is Aaron Siri. You may want to run your issue past Del Bigtree at the Highwire to see what he thinks.
Ouch, you have hit a raw nerve there, Sherman! See:
On Wednesday, July 21st, 2021 at 5:11 AM, <h.rees@pharmaflowltd.com> wrote:
Dear ICAN,
I am an expert in biopharmaceutical supply chains – please see my resume attached.
Also, I have a long history as a campaigner for wholesale reform of Big Pharma, and am well known as an industry insider who speaks truth to power.
There is so much people don’t know about the supply chains for these vaccines. Quoting from my latest book – “Pharmaceutical supply chains produce the drugs that enter a patient's body. If anything goes wrong in production, even though the Regulatory Authority has approved a drug for sale, it can have a devastating impact.”
These are the things people don’t seem to know:
• None of the 4 vaccine ‘manufacturers’ developed or manufactured the vaccines themselves. None of the manufacturers have ever had a vaccine as part of their product portfolio, so they could be deemed as lacking sufficient experience to sponsor vaccine development and manufacture.
• For Pfizer/BioNTech and Moderna mRNA vaccines, Lonza manufacture the bulk drug substance and ship to Catalent Pharma Solutions for the fill/finish.
• For AZ/University of Oxford, Oxford BioMedica developed and manufacture the adenovirus bulk drug substance, and Wockhardt carryout fill/finish.
• For Janssen (J&J)’s adenovirus, it is the same contract manufacturers as Pfizer/BioNTech and Moderna.
• The manufacturers are legally responsible for the work of the contract manufacturing companies, according to CGMP, which is included in the US Code of Federal Regulations (CFR).
• FDA's portion of the CFR is in Title 21, which interprets the Federal Food, Drug and Cosmetic Act and related statutes, including the Public Health Service Act.
• The main elements of CGMP are: 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs. 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals. 21 CFR Part 600. Biological Products: General.
• In my expert view, it is physically impossible to develop vaccines on the timescales they have been, without contravening major elements of CGMP, such as process validation, audit of suppliers, change control, etc, etc.
I personally spent 6 months consulting at Oxford BioMedica on the Lentivirus vector used in Novartis’ Kymriah CAR T gene therapy treatment for blood cancers and there is no doubt the vaccines are gene therapy.
Please let me know if I could help further in any way.
Kind regards,
Hedley
Hedley Rees
Managing Consultant and Author
PharmaFlow Ltd
T: +44 1656 655664
M: +44 7734 961726
Book: Supply Chain Management in the Drug Industry: Delivering Patient Value for Pharmaceuticals and Biologics - Read Me
Book: Taming the BIG PHARMA MONSTER by Speaking Truth to Power – Read me
Book: What Patients Need to Know About Pharmaceutical Supply Chains – Read me
THIS IS WHAT I RECEIVED BACK (thank you to ICAN)
From: Elizabeth Brehm <ebrehm@sirillp.com>
Sent: 28 July 2021 15:30
To: h.rees@pharmaflowltd.com
Subject: FW: Vaccine manufacturers have broken the law (FDA cGMP) relating to their supply chains
Hi Hedley,
Thank you for your email below. ICAN shared it with us. I’d like to potentially discuss ways in which you may be able to assist. For example, would you be willing, if needed, to provide a declaration laying out the facts that support your conclusion that it is impossible that all of the CGMP standards are being met? Please advise.
Regards,
Elizabeth
Elizabeth A. Brehm, Esq.
Siri | Glimstad
200 Park Avenue
Seventeenth Floor
New York, NY 10166
P: 212-532-1091
F: 646-417-5967
www.sirillp.com
This was my reply:
To: h.rees@pharmaflowltd.com
Subject: RE: Vaccine manufacturers have broken the law (FDA cGMP) relating to their supply chains
From: h.rees@pharmaflowltd.com <h.rees@pharmaflowltd.com>
Sent: Wednesday, July 28, 2021 10:41 AM
To: Elizabeth Brehm <ebrehm@sirillp.com>
Subject: RE: Vaccine manufacturers have broken the law (FDA cGMP) relating to their supply chains
Hi Elizabeth,
Yes indeed – I would be happy to provide a declaration. I wrote to EMA 12 months ago about some of the issues and received a polite email back saying they were happy with everything!
Please do let me know what the format is for a declaration and anything else I need to know.
Kind regards,
Hedley
Following that communication in July 2021, I supplied Elizabeth Brehm with a substantial amount of information on how the SARS-CoV-2 injections must have been fraudulent. I was then asked to respond to this email:
Hi Hedley,
Wanted to run the attached complaint by you. Would love to know what you think about the allegations and claims (this is not a complaint I have been involved with at this point).
Thanks and hope you are well.
Elizabeth
Elizabeth A. Brehm, Esq.
Siri | Glimstad
745 Fifth Ave
Suite 500
New York, NY 10151
P: 212-532-1091
F: 646-417-5967
www.sirillp.com
The defendants included Merck KGaA, Darmstadt, Germany (Merck KGaA), Sigma-Aldrich Corp and MilliporeSigm, and the case related to contravention of cGMP, especially contamination.
After supply all this information, and eventually Aaron Siri being patched into a Zoom call with Elizabeth Brehm and myself, nothing else happened.
When I complained, Elizabeth Brehm emailed to say "we didn't use any of your information".
I've had to become very philosophical to stay sane in what is happening in the world today!
Thanks for letting me get that off my chest Sherman :O)
Oh Noooo, did not expect to see this. They have a deep background into FOIAs, as they have done these so often. Most likely doesn't help that they've been busy since the rollout with around 40 attorneys on staff. More recently, Aaron has been called to different state's legislatures as well as the US Congress to testify. Changes are afoot. You may still want to consider contacting Del BigTree at ICAN to see what he thinks about a possible FOIA to get what you need. You never know looking under which rock, where the missing key is to stop the insanity.
Welcome to the FOIA club 'F#ck Off Idiot Amateur.'
:O) Yes Timothy, a very apt description. Not giving up though. There is a very interesting picture emerging on how the global scam was played, with some very prominent, yet undiscovered players revealed. It surpised me, that's for sure...more to come...
Yes they will always have the last laugh when 99% is redacted.
The only positive JAS is that there is more than enough visible to work out the scale of the non-compliances - but no action was taken. 13 observations on a Form 483 would have put shudders down the spine of plant managers 20 years ago...
.
The Vaccinated Are Human Derivatives.
I Suggest We Make A Market And Trade Them.
And I Offer A Side Bet:
That They Would Willfully Participate.
.
Yes Thomas, you are probably right!!!
Brilliant! And sadly true as to the participation.
Have you tried going to one of the congressional committees? Perhaps, send them the info you have and the responses you've received. The research was bought and paid for by taxpayers already.
Are you based in the US Geckogirl? Senate websites seem to want you to have an address with a US state? Anyway, this is the most relevant committee I think (HELP):
https://www.help.senate.gov/about/members Meanwhile, I'll go on trying to send the information I have.
Rand Paul is on that committee. Recommend drawing his attention.
Yes; Hawaii
Hadn’t thought of that. Think the HELP Committee may be best? Only thing is I am not a US citizen, live in UK - any idea how I could get through to them? Thanks Geckogirl. Hedley :O)
So freedom of information, to citizens, is not free...