Point of Care Manufacturing: the Trojan Horse to introduce gene therapies
Another one you couldn't make up
UK Government gives the green light
Whether you know it or not, UK Government, through MHRA, now allows hospitals to manufacture at point of care, but only for advanced therapies, which include gene therapies. This is the announcement:
It claims:
“The establishment of a regulatory framework for POC manufacturing would bring a range of benefits to patients, healthcare professionals and innovators.”
“The UK will be the first country to introduce a tailored framework for the regulation of innovative products manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced today. This will mean that new medicines with very short shelf lives and highly personalised medicines can more easily be made in or near a hospital setting or ambulance and can get to the patients who need them much more quickly.”
It’s hard to explain how fool-hardy, and dangerous, that is. Wait though, they did a consultation in January 2022:
“Overview of consultation activity
A total of 51 complete responses were received, 16 were from individuals and 35 were from organisations. Although some organisational responses were from single organisations or single academic institutions, several were from larger groups that represent many companies or institutions with a range up to approximately 330 companies.
Responses were received from across the UK and internationally. The majority of individuals, 15, were from GB and 1 was from Canada. The organisational respondents’ coverage were: 9 from GB, 13 UK wide, 2 Northern Ireland based, 2 operating in both the UK and the EU, 1 from Italy, 6 from global organisations and 1 did not indicate their area of coverage.”
So, 51 unidentified consultees, 16 individuals and 35 organisations. Blimey, that’s rather a miniscule sample size, isn’t it? Apparently, that was enough to get it through to full implementation. They must think we are idiots!!!
The Paper that sealed the deal
This is the paper on the subject that UK Government and MHRA relied on to trust the approach:
Redistributed Manufacturing in Healthcare Creating New Value through Disruptive Innovation
I can tell you unequivocally that this is academic theory, detached from the realities of the real world. I have known Professor Wendy Phillips, Professor of Innovation, University of the West of England (UWE Bristol), for many years. She wrote the Foreword.
Professor Phillips asked me to help judge applications for projects related to this area in late 2020, which I agreed to do on a pro bono basis. As far as I was concerned, the four projects were early-stage research. This is an example of my scoring template for one of the projects:
Note my comment: “This is potentially a high impact project. However, the formulation development and clinical aspects such as bioavailability and potential interactions could be challenging.”
‘Challenging’ in this context means there’s a ton more work to be done, and that would take several years working with experienced pharmaceutical drug developers. Even then, the personalisation aspects have huge barriers ahead of them.
I’ve submitted a FIOA to UWE, asking for details of funding and also asking:
In light of the above, I am compelled to ask if this White Paper has been scrutinized and endorsed by any experienced practitioners in Advanced Therapy Medicinal Product supply chains?”
Will keep you updated.
Oh, and the US is into it too:
Distributed Manufacturing and Point-of-Care Manufacturing of Drugs | Discussion Paper
It begins:
“This discussion paper presents areas associated with Distributed Manufacturing (DM) and Point-of-Care (POC) manufacturing that FDA has identified for consideration as FDA evaluates our existing risk-based regulatory framework as it applies to these technologies. The discussion paper does not constitute guidance; instead, its purpose is to gather feedback from the public to inform future policy development.”
Here is a paper of one example, from Mayo Clinic in the US:
The Rise of Point of Care Manufacturing: The Mayo Clinic Experience
Cooked up by doctors that have never manufactured a medicine in their lives, what could possibly go wrong?!
This is what happens when they find out how easily the population acquiesced to allowing themselves to be injected with an experimental “vaccine”. The majority of people had no problem becoming part of a drug trial without informed consent when told it was for their safety and the greater good.
Ouch!
All I can say is that I hope never to be ill enough to enter a hospital.
Thanks Hedley.