Errors in the pharmaceutical supply chain can harm patients, even kill them, if safety checks and protocols are not in place and observed. Did the breakneck speed in assembling supply chains for COVID-19 vaccines put patients at risk? That will only become clear when MHRA physically inspects the companies producing the Covid injections and acts on its findings.
For those not familiar with supply chains, they bring us the food we eat, the cars we drive and the mobile phones we use to communicate. In fact, every product we consume must come to us via a supply chain. It is the series of stages a product must go through to be converted from raw materials into a finished product. This applies as much to medicines as to any product we consume.
The added complication with medicines is that they go inside your body, but unlike food, they start off as an unknown substance. No-one knows what the medicine will do to you, or what your body will do to the medicine as it is broken down when inside you. It may come as a surprise to some, but the body can convert an apparently safe medicine into a toxic one if it collects in some vital organs.
A company developing a new medicine must first construct a supply chain to produce a known quantity of the medicine’s active ingredient, typically 10 kilograms or litres.
Nowadays, large pharmaceutical companies use contractors to develop and produce medicines, so it can take months, even a year or more, to get all the agreements in place. Once that is done and the supply chain is operational, the medicine under test is sent off to study safety in animal models. The average timescale to get all this done is three years.
If the medicine is proven safe enough to test in humans then the company can apply for a licence to move onto that phase. If the clinical trial application is successful then studies can be run using human volunteers.
From this stage onwards, the supply chain must be closely regulated to ensure that the medicine will not harm the volunteers in any way. In the U.K. this is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA). There are three main responsibilities in its remit:
- Issue licences that allow companies to place medicines on the market.
- Inspect and license key manufacturers and distributors in the medicines supply chain.
- Monitor the safety of medicines
Evaluating a licence application to market a medicine is based on a document that has been mandated across the world for decades. It is known as the electronic Common Technical Document (eCTD). The company applying for a licence must use the eCTD to submit data aimed at proving that the supply chain will consistently produce safe and acceptably effective medicines. This is known as chemistry, manufacturing and controls information (CMC). This is the pharmaceutical industry’s name for all the details of the supply chain from beginning to end.
The second responsibility is to physically inspect the companies producing and distributing the medicine. A site inspection normally takes three or four days, carried out by at least two experienced inspectors. Once the inspection is complete, a report must be written, recording findings and highlighting any observations of critical of major deviations. It is not unusual for companies to have to remediate issues before a licence can be awarded, which can take months, even years.
The third responsibility, monitoring the safety of medicines, is the Yellow Card system, which may be familiar to some readers. However, the primary responsibility for the safety of medicines lies with the company holding the product licence under its obligations to maintain a pharmacovigilance process.
For the Covid injections, MHRA introduced a shortcut version of the above established authorisation process for new medicines, termed a temporary authorisation. Along with that, conditions of authorisation were issued by MHRA to substitute for the normal process. These were woefully inadequate in relation to safety of the supply chain. There was no mention of the supply chain companies that physically developed and produced the Covid injections.
In the case of AstraZeneca (AZ), supply chain activities were outsourced to two companies, Oxford BioMedica, headquartered in Cowley, Oxford, and a Wockhardt facility located in Wrexham.
To date, it is unclear whether these production facilities have been physically inspected by MHRA. We know that distance (a.k.a. virtual) inspections were used during Covid, but they are about as useful as a chocolate teapot. In May last year the MHRA announced it was resuming physical inspections, implying none had been carried out since 2020. Only when production facilities for all the Covid injections have been visited and inspected will we have a clear idea if there are quality problems in the supply chain. This is a question for MHRA to answer so that the public are reassured.
What kind of quality problems? The risks lie in defective and contaminated materials and products being introduced at any point in the supply chain. The vaccines are known as biologic products, which means they are produced using living organisms. They are extremely unpredictable, and every manufacturer produces a clinically different product, which is a cause for concern if there is chopping and changing of injections. The biggest challenge of all with these products is the cold chain and the associated activities such as freezing and thawing materials that can change molecular form and become toxic.
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).”
Readers may not know, but the vast majority of pharmaceutical materials have been sourced offshore from low-cost countries, mainly China, since the early 1990s. This makes proper oversight of the supply chain impossible in many cases.
In light of the above and the recently exposed infected blood products scandal that caused such tragic outcomes, there is not a moment to lose. The first step is to accept that this is a dangerous problem that calls for immediate action.
As a minimum, all products that have been authorised under the conditional authorisation process must have their licences revoked and sales should cease immediately.
The next step is a product recall by MHRA’s Defective Medicines Report Centre (DMRC), according to its procedure titled: ‘A Guide to Defective Medicinal Products.’
This is an excellent document as it covers all the stakeholders involved — patients, healthcare professionals, manufacturers and distributors — and provides guidelines for reporting, investigating and recalling suspected defective medicinal products.
Note the operative word suspected, so there is no presupposition of guilt at this stage. Any next steps should follow from the investigation.
Hedley Rees is a specialist in biopharmaceutical supply chain management with over 40 years’ experience, founding PharmaFlow in 2005. His Substack, Inside Pharma, has been publishing evidence of Covid supply chain malfeasance since January 2022.
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Well speaking of clones and doppelgangers, this is where our Nigel comes into his own. What a badass.
https://x.com/GaryBrumz/status/1808523412064649562
Terrific Mogs
Brill
I love how Johnson’s had a total transformation after losing 30kg and a trip to the barbers.
Is it just me or does Keir Starmer share the same furrowed brow of a monkey worriedly looking at a wiring diagram of a Ford Capri? His anxiety about possibly being caught saying something inappropriate is amplified by his nasal and pedestrian delivery – the man isn’t going to know his ass from a hole in the ground in a fortnight.
Correct so he will hand over to Khant at some point
That is the intention Freddy as I have posted more than once.
Fishy and Kneel sound the same because they are both little WEFfers.
Reinhard Tristan Eugen Miliband
Because they get their orders from Davos, it’s common knowledge.
To be fair, the Green Goblin does turn up well in a small pair of shorts.
“but all those… doubles… are there precisely because if Putin goes, Russia will once again be redefined [so his death would perhaps have to be covered up to prevent chaos]”
Surely that can be a double edged sword considering that if they chose a double, bumped off the real Putin, then put in their puppet until they have gained power.