11 Comments
User's avatar
Patricia's avatar

I think you would be very hard pressed to find any regulatory body anywhere which has not been compromised. Ditto any organisations and structures which wield power over the masses.

Expand full comment
alisonw's avatar

This is somewhat on topic and somewhat off topic to today's post Hedley. I wanted to get your thoughts on the latest March/April new. https://www.expresspharma.in/sanofis-mrna-vaccine-candidate-for-prevention-of-chlamydia-infection-gains-usfda-fast-track-designation/ Why is the FDA fast tracking mRNA gene therapy for Chlamydia after the Covid mRNA disaster? The company is Sanofi and it's obviously another money grab. We know insurance will incentive MDs to promote the mRNA vaccines for Chlamydia. The side effects from the mRNA jabs which will likely include cancer, and sterility will be significantly greater than the disease. Chlamydia has been easily treatable for decades with antibiotics. I can imagine every college campus, OBGYN and GPs office promoting these deadly jabs. Sanofi is also using the same asymptomatic strategy that was applied to Covid to maximize market share.

I mistakenly thought now that Dr. Marks has departed, we would be seeing an end to the mRNA platform especially for infectious diseases. You've done an amazing job outlining whose been involved in the Covid jabs especially in the UK. Do you have any insight into what is going on at the FDA. Why would they decide to fast track another mRNA jab after the injuries and deaths we've seen from the Covid shots and all the 483s. It seems like the FDA should be abandoning this platform for everyone's safety and not the other way around when it's clear you can't get this platform to work.

Expand full comment
Hedley Rees's avatar

Thanks Alison - another great catch! There are massive redundancies at FDA since Marty Makary took over as commissioner. Makary has no experience of pharma regulation, and he will not know who he can trust. It's a shot gun approach that could make matters worse in the short term.

Robert Califf, the previous commissioner, is stirring up the ones who will be looking for new jobs and there is a lot of bad feeling. If you are on LinkedIn, which I have managed to creep back onto after a 3 year ban, you can see it. Also, FiecePharma is a good resource, although big pharma biased: https://www.fiercepharma.com/pharma/recently-departed-cber-director-warns-fda-staff-cuts-could-upend-drug-review-timelines-early

Expand full comment
The Situation Room's avatar

.....and AstraZeneca was trialled in the US (known because of Brianne Dressen, an American injured in the US arm of the AZ trial). We also know that the US ordered AZ vaccines but cancelled using them after AZ messed up the dosage in their clinical trials and then the UK reduced down to 12 weeks between dose 1 & 2 when the trials were on 3 week intervals.

Expand full comment
Hedley Rees's avatar

See: https://www.pharmaflowltd.com/open-letter-to-professor-cooke-interim-co-chair-at-uks-mhra-should-the-need-for-a-product-recall-of-the-astrazeneca-sars-cov-2-sterile-injectables-be-investigated-by-the-defective-medicines-report-c/

"Dear Professor Cooke,

In the wake of AstraZeneca withdrawing its vaccines from sale, can MHRA confirm that the need for a product recall is being actively investigated by MHRA’s Defective Medicines Report Centre (DMRC)? If this is not the case, I would urge MHRA to immediately instigate investigation action, as laid out in ‘A Guide to Defective Medicinal Products’, published by MHRA. I note that the role of the DMRC is explained in the document, as follows:

“The role of the DMRC is to minimise the hazard to patients arising from the distribution of defective medicines by providing an emergency assessment and communication system between manufacturers, distributors, wholesalers, pharmacies, regulatory authorities and users”

The prospect of defective medicines being present in the supply chain cannot be ruled out. No matter if MHRAs Executive believes this risk is low, prudence dictates that a formal investigation takes place, as detailed in your document above. This is because while AstraZeneca has halted the sale of these products, production and distribution supply chains remain active. It is typical for suppliers of raw materials to be working two or more years in advance of finished product manufacture. These raw materials will be sourced globally, particularly in China, and will have been delivered to the various downstream facilities producing drug substance (DS) and drug product (DP) located in many different countries. It cannot be assumed that adulteration of one or more of these materials has NOT taken place, either accidentally or purposefully. This is a quote from a recent article of mine published in the Daily Sceptic:

“The potential for harm by the pharmaceutical supply chain is incalculable and there is compelling evidence of that. During 2007-8, a blood thinning agent, heparin, become toxic when the product licence holder (Baxter) procured a substance that had been illegally substituted for the genuine material; it was 100 times cheaper. The report: ‘After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs’, authored by PEW Health Group, explained the horrible details, stating:

“The FDA examined a subset of 574 adverse events, including 68 deaths, submitted between January 1st 2008 and March 31st 2008.”

You will be aware that AstraZeneca retains full responsibility for ensuring that the public is kept safe during wind-down of production and activity in the distribution supply chain, including hospitals and pharmacies. Considering the above, your urgent response is requested. If you would like further evidence of the risk of defective products being present in these biologically sensitive supply chains, I would be more than happy to make it available to you and your colleagues at MHRA.

Yours sincerely,

Hedley Rees, Managing Director, PharmaFlow Ltd."

Expand full comment
Sunface Jack's avatar

It clear it is a criminal enterprise, that have state protection against any liability for harm caused.

Expand full comment
Hedley Rees's avatar

Under product liability laws, given they can be proven to be defective products, a class action would have a very good chance of succeeding, especially with ne writing an expert report and testifying under oath 👊

Expand full comment
Hedley Rees's avatar

Me not ne 😂

Expand full comment
Crixcyon's avatar

Looks like a great list from the lunatic asylum.

Expand full comment
gusman's avatar

all on thetaketogivein demnityto neverusedbrfor mrna

Expand full comment
gusman's avatar

mrh 75%uby big phmarmaester mcvieath the esxes death debatesin uk parlment

Expand full comment