FDA Reports Hospitalizations & Deaths Linked to CAR-T Cell Immunotherapies: Potential for Imminent Regulatory Action
This could be a gamechanger!!!
TrialSite News drops a bombshell
This article below drew my attention last week. Having just circled back and read it again, it could be a gamechanger:
I’ve picked out the salient points so that subscribers to Inside Pharma can get the picture. I think also a couple of articles are free to view before the paywall kicks in.
Anyway, here are a few snippets:
The Food and Drug Administration (FDA) reports receiving accounts of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies. Reports were received from clinical trials and/or post marketing adverse event (AE) data sources. The FDA reports hospitalization and deaths and potentially an imminent need for regulatory action.
Imminent need for regulatory action?
Action would blow the whole gene therapy hoax, as these therapies all use the same technology and supply chain processes! You can learn more on the topic below:
The article goes on: T-cell malignancies have occurred in patients treated with several products in the class. The FDA notes that all gene therapy products involving integrating vectors (lentiviral or retroviral vectors) come with the potential risk of developing secondary malignancies. Thus, they are labeled as a class warning in the U.S. prescribing information (USPIs) for approved BCMA-directed and CD19-directed genetically modified autologous T cell immunotherapies.
One of the products under investigation is Novartis’ Kymriah, approved by FDA in August 2017. The active ingredient (lentiviral vector) is manufactured by Oxford Biomedica, a company I have reported on many times, since they also manufacture(d) the AstraZeneca injections, see:
Room for optimism?
If these go down after FDA investigation, gene therapy does too. The side effects of these products have been around neurological toxicities and cytokine release syndrome (cytokine storm)—now we have accounts of T-cell malignancies—is it coincidental that turbo cancers are being reported by honest doctors?
I’ll keep a close eye on this and let you know if further revelations turn up.
Fascinating and very much expected, as we do not understand how the genome truly works. But before understanding anything, we just want to manipulate everything, for profits, no less!
It truly is insane. It will fall by its own weight.
Thank you for sharing Hedley!
i work in the biopharma industry.
have contacts at kite/gilead
kite has commercially dosed many, many more patients w/ its 2 approved cart's since first approval in 2017. kite's approved indications are non hodgkings lymphoma & mantel cell lymphoma.
they are vertically integrated = dont use outside CDMOs for manufacturing like most of their competitors
i read that since 2017, approx 30-40k patients in total have received a car t cell therapy - all of which are aimed to treat blood cancers
kite will does 18000+ patients this year alone
a contact, with access to PV/pharmacovigilance/drug safety data + access to related complaints and other QA/QC issues has said: 0 adverse events reported by commercial patients as of june/july 2023
i wonder how the mrna shots could be implicated in this.
Ed Dowd has run the stats using public databases and cancer rates across almost every demographic are jumping higher since....2021