UK's gone bonkers over gene therapies—but they don't know what they don't know
Patients lives are at risk unless they stop, now!
MHRAs FOI response is deeply concerning
You may remember the FOI that I submitted to MHRA last November. This is the FOI request.
The FOI questioned a change that MHRA has made to its regulations allowing hospital pharmacies and other facilities carte blanch to ‘experiment’ with gene therapies. They achieved this by changing the age-long definition of ‘Reconstitution’ in the industry. This is what it was:
ANNEX 13 Investigational Medicinal Products
Reconstitution should be understood as a simple process of dissolving or dispersing the investigational medicinal product for administration of the product to a trial subject, or diluting or mixing the investigational medicinal product(s) with some other substance(s) used as a vehicle for the purpose of administering it.”
Since 1st January, 2022, the definition has been changed to:
“16. Reconstitution of product after batch release
16.1 Reconstitution activities
16.10 Reconstitution activities can be performed at the administration site (eg hospital pharmacies) outside of a GMP environment.
16.11 For the purpose of these Guidelines, the term “reconstitution covers activities required after batch release and prior to the administration of the ATMP to the patient, and that cannot be considered as a manufacturing step.””
It is stressed that these examples cannot be extrapolated to medicinal products other than ATMPs:
•Thawing, washing, buffer exchange, centrifugation steps necessary to remove preservation solution (e.g dimethyl sulfoxide [DMSO]), removal of process related impurities (residual amount of preservation solution, dead cells) including filtering
•(Re)suspension, dissolution or dilution with solvent/buffer, dispersion;
•Mixing the product with patients own cells, with an adjuvant and/or other substances added for the purposes of administration (including matrixes). However, the mixing of a gene therapy vector with autologous cells is a manufacturing activity that should be conducted under GMP;
•Splitting the product and use in separate doses, adaption of dose (eg cell count);
•Loading into delivery systems/surgical devices, transfer to an infusion bag/syringe.”
How do I explain how dangerous this is?
I’m finding it challenging to explain to people how dangerous this is, given that the public don’t know enough to judge.