What Can Robert F. Kennedy Jr. do to Tame the Big Pharma Monster? PART 2

This is the truth, the whole truth, and nothing but the truth, so help me God...

Since this is PART 2, you may wish to look at PART 1 (although I didn’t know there would be PART 1 at the time!):

What Can Robert F. Kennedy Jr. do to Tame the Big Pharma Monster?

In summary

In the light of Donald Trumps amazing victory, PART 1 welcomes Robert F. Kennedy’s knowledge of all things BIG AND GLOBAL, including Big Pharma.

It then identifies the ROOT CAUSE of Big Pharma’s malfeasance:

Patenting molecules without a supply chain that proves they work in a disease.

Without a working (safe and effective) supply chain for drugs, you ain’t going to get any new drugs to market. With no new drugs, the patent cliff left big pharma with nothing to sell, other than ‘therapies’ for rare diseases.

With $six figure+ price tags, dangerous side effects, and impossible to manage biologic supply chains, all they could do was cheat.

Enter SARS-CoV-2 injections in 2020 - The Cheat

The COVID injections were merely a rebranding of the CAR T therapies for rare blood cancers (eg Novartis’ Kymriah), only administered to the global population, instead of a single patient!!!

Before tackling root cause, containment comes first

We then suggested that before tacking root cause, there was the urgent need for containment. The Cambridge Dictionary defines containment as “the act of controlling or limiting something or someone harmful.”

Suggestions for containing the harm

There is something you must be absolutely convinced about before reading what will follow.

The SARS-CoV-2 (supposedly sterile) injections were/are physical objects that were shipped all over the world in their billions of doses.

They were manufactured by contract development and manufacturing organisations (CDMOs - eg Lonza, Visp, Switzerland and Catalent Pharma Solutions, Bloomington, US).

Pfizer and all the other Big Pharma’s sold off their development, manufacturing, and distribution assets in the 1980s.

These are the stages they go through:

Raw materials are sourced mainly in Asia, as are starting materials (cell lines). They are shipped to one or more CDMOs doing upstream processing (making drug substance). Then they are shipped again, possibly over thousands of miles, to one or more CDMOs doing downstream processing (making drug product).

Then the filled/capped vials were shipped to vaccination centres, and similar establishments.

Who knows where these, some hazardous/toxic materials and products, are now?

The companies selling them - Pfizer/BioNTech, Moderna and AstraZeneca - don’t know diddly squat about where they are. They are, however, legally responsible to ensure they are identified, located and disposed of safely. That includes every stage in the supply chain, including hospitals, physicians surgeries, drug, grocery and supermarket stores, that were thawing, mixing, storing and injecting patients.

This is the #1 containment action, and it’s for Regulatory Authorities globally to take the lead.

I’ve already began by sending an open letter to Professor Grahame Cooke, interim Chair of UKs MHRA, see here:

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 Centre?

It begins:

“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”

This is Professor Cooke’s reply (over 3 months later)

“Mr Hedley Rees

By Email: h.rees@pharmaflowltd.com

Reference: CEC 189744

18 September 2024

Dear Mr Rees,

Thank you for your email of 7 June 2024.

Thank you for your open letter to Professor Cooke, communicated to the MHRA, in which you discussed whether the need for product recall of the AstraZeneca SARS-CoV-2 sterile injectables be investigated by the Defective Medicines Report Centre

The AstraZeneca (Vaxzevria) Covid-19 vaccine was approved for use by the Medicines and Healthcare products Regulatory Agency following stringent safety, quality, and efficacy assessments. Before any medicine or medical device is approved for use, it undergoes rigorous testing and evaluation. This includes clinical trials and laboratory tests to ensure that the product is safe and effective for its intended use. The AstraZeneca (Vaxzevria) Covid-19 vaccine was not defective against its set specifications at the time of issue, distribution and use.

Vaccine manufacturers, as for any medicines manufacturers, are subject to an initial inspection by the MHRA which is then followed up by risk-based inspections to verify the standards of the facility, that operations comply with Good Manufacturing Practices, and that products are manufactured in accordance with details on their marketing authorisation.

Furthermore, once approved for marketing and supply, the Covid-19 vaccines were batch tested by the MHRA Official Control Laboratory to ensure each batch of product met the quality standards defined in their marketing authorisation. Batches that complied with the required specifications were certified and released by the manufacturer onto the UK market.

Once a product is on the market, the MHRA continues to monitor its safety through various mechanisms. As for all other medicines, the AstraZeneca (Vaxzevria) Covid-19 vaccine was subject to the MHRA’s safety monitoring strategy to identify safety issues. This monitoring strategy is continuous, proactive, and based on a wide range of information sources. A dedicated team of scientists' review information to look for suspected safety issues or unexpected, rare events. The MHRA’s ongoing vigilance helps to ensure that the benefits of approved products consistently outweigh any potential risks, thereby safeguarding public health.

The AstraZeneca (Vaxzevria) Covid-19 vaccine been withdrawn from the market by the manufacturer and there are no more supplies available in the UK. The DMRC assesses any reports of suspected defective medicinal products to minimise the hazard to patients arising from the distribution of defective medicines. The DMRC therefore does not routinely recall products that have been withdrawn from the market.

I hope this information is helpful.

Yours sincerely,

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000”

This is point blank refusal to take patient safety seriously

So, the professor is happy that nothing in the slightest could have possibly gone wrong with the development, manufacture and distribution of the AstraZeneca injections that were rushed to market in 12 months, when all the facility inspections were virtual, or ‘distance inspections’ as they called them.

They had their chance to react - now is the time to hold all their feet to the fire!!!