Bridgend, South Wales, 6th June 2024: Hedley Rees, managing director at PharmaFlow, a 21st century consultancy in biopharmaceutical value chain management, calls for MHRA to investigate if AstraZeneca must instigate a product recall of its SARS-CoV-2 sterile injectables.
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.
Email: h.rees@pharmaflowltd.com
Hi Hedley, This beggars belief! The mere fact that you deem it necessary to write this letter to the MHRA speaks volumes. In my humble opinion they truly are not fit for purpose. They are supposed to be the safe guard for us the public, l have no faith in them whatsoever. Many thanks Denise.
Very wise Denise. MHRA is hiding the truth and batting away every FOI request that looks even slightly as if it is asking for the truth…
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Thanks Daily Sceptic! You do great work 🙂
Slight problem, AstraZeneca withdrew the vaccine because it was no longer required, it was a commercial decision that was publicised at the time.
The mechanism by which clots very rarely occurred is identical to that which causes clots in some patients after having heparin injections (HITT) specifically the formation of complexes with platelet factor 4, this causes anti-PF4 antibodies.
These antibodies have been found at post mortem in patients who had had clots following the AstraZeneca and the J&J vaccines.
John – if any product is proven defective once placed on the market, there is no ‘commercial’ argument. If I sold a hair dryer where some of them gave people an electric shock, I wouldn’t be allowed to just walk away. Does that make sense? or no?
Are you advocating that heparin/dalteparin should be withdrawn as HIT can affect up to 10% of recipients according to the BNF. What about the other medications that have severe side effects as listed in the BNF? The problem is that everyone is unique, particularly in respect of the immune system.
See: https://www.pewtrusts.org/-/media/legacy/uploadedfiles/wwwpewtrustsorg/reports/health/pewheparinfinalhrpdf.pdf – 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).” Covered here in the Daily Sceptic https://dailysceptic.org/2024/05/23/mhra-never-inspected-the-production-facilities-of-covid-vaccines-so-how-can-it-know-they-are-safe/?highlight=hedley%20rees Remember, it’s the supply chain product that goes into a patient’s body, not science…economic adulteration is rife in the pharmaceutical supply – so please be cautious John.