Professor @TuftsMedSchool, Co-Founder @Naveris_inc. Dedicated to understanding the biological, molecular, and genetic underpinnings of cancer & prevention.
Really? Not the advances in treatments? Curious the mortality curve abruptly decreases right after the approval of Herceptin, letrozol/anatrozole in late 90s….
And to be clear, I’m not saying improved early detection plays no role- but the change in the mortality coincides with the advances in treatment. Breast cancer screening started in the 1970s…this means it took more than 20 years before screening practices had an effect on mortality.
Academic scientists are human beings that choose a career path that depends on grant funding for their existence. Grant funding is directly linked with job security and salary support. This was not the case 30-50 years ago.
Today scientists have no choice but to find and obtain funding where they can if they want to keep their jobs and actually do research. This means that the funders of research have an overwhelming influence over their work and their ideas.
So it’s not that most scientists are corrupted- it’s that most scientists are not independently wealthy and must consider food and housing insecurity during their decision making process.
Pharma (and the system) has exploited this weakness/ insecurity which means we now have scientists with compromised incentives. It’s not always their fault- unfortunately, the capture is very deep.
And it’s a slippery slope if your research interests happen to overlap with Pharma’s interests...
Postdoc position in vascularized liver NAMs for applications in drug development and disease modeling, as part of the new NIH-funded NAMs Technology Development Center for Women's Health. Emphasis on sex-specific model development, interactions with biologics, and metabolic behaviors. Email cv, statement, and list of references to [email protected]
No I don’t agree with that statement…
The lack of studies creates an evidence gap- not reassurance that there is no harm . Unstudied risks cannot be presumed safe, especially in the case where we know a lot about the harms and reactions to foreign or plasmid DNA - especially when encapsulated in LNPs.
Yes I have- there are several studies that have looked at fate of naked plasmid DNA following IM injection in mice. They’ve measured integration rates at 10^-5, but showed extrachomosomal retention of plasmid DNA for days/weeks following injection. Happy to send you those references if you’d like- none of them used LNP encapsulated DNA however.
Th other important publication is from the FDA/CBER on the topic of DNA integration in vivo...
https://t.co/Q1hHccYovY…
Under highly sensitized conditions, extremely small amounts of linearized plasmid DNA encoding cooperating oncogenes can induce tumors via genomic integration, whereas non-oncogenic DNA does not.
They showed tumor induction detectable at:
~25 ng (circular plasmid)
~800 pg (linearized plasmid, more active)
There have been no studies testing the DNA byproducts in the mRNA vaccines using this assay- I can send you what I found about this. No data about plasmid encoding Spike DNA or the SV40 promoter… I know folks who are working on these studies but it’s not the FDA or the manufacturers. And results are not yet published
Agree- but as there have been no studies or funding to look at patient-oriented outcome of harm , and the FDA has been unwilling to share any data on this….combined with the chilling climate within the medical and scientific community to study this, outright dismissal of any possibility DNA contamination could have an effect is intellectually dishonest.
We all completely agree there is no data one way or another on this. What has become difficult to accept (especially 6 years later) and with the rollout of other mRNA vaccines-is why. Where are the data? Where is the funding for these studies? This is not a difficult question to answer. Why don’t we have the answers?
@TheSGEM - every single vial of mRNA vaccine product contains DNA byproducts in them. Both the TGA (Australia) and the PEI (Germany) have reported the levels of the KAN resistance gene in the vaccines- and rhey were not inconsequential- they ranged from 1-9ng! This is plasmid DNA , not genomic DNA. And this is LNP-encapsulated DNA, not naked DNA.
The manufacturers have also reported to the FDA the presence of plasmid DNA influshing in Pfizer’s case- SV40 promoter sequence. What has never been shared or transparent is the quantity of spike DNA present in each vial. Some have estimated this to be 100x higher than Kan or SV40.
In addition to this glaring omission is the other concerning issue related to the “established permitted” DNA thresholds. The <10ng was established for NAKED DNA- and from cell lines- neither of which is pertinent to the DNA in mRNA vaccines.
The FDA has not established thresholds for LNP-encapsulated DNA.…and six years later, we still have no data on the fate of the DNA fragments present in mRNA vaccines.
In addition to this glaring safety concern/oversight, the WHO in 2022 (after the mRNA vaccines were deployed) clearly stated that there are no established guidelines for the manufacturing of mRNA vaccines and that each country will be responsible for setting those guidelines for themselves. Six years later and the FDA still has not established those guidelines.
So we have no data on the fate of the DNA in mRNA vaccines, we have no established thresholds on LNP-encapsulated DNA in mRNa vaccines, and we have no established manufacturing and safety guidelines or standards on these products…..
Interesting that these same regulators do not seem to be bothered about the safety concerns with DNA impurities in mRNA vaccines, that have been shown to trigger immune responses that could lead to "life-threatening and catastrophic reactions."
Seems like a glaring double standard.... And even if the FDA staffers do not want to conclude that the risks are identical, they do have an obligation to explain why they are treating them differently.
Not really- the only similarity is the use of term “ recombinant DNA technology” in the manufacturing but they are actually completely different methods .
For mRNA production plasmid DNA is introduced into bacteria and the bacteria are used as factories to produce the large quantities of DNA template. The DNA is extracted and purified from the bacteria . This DNA is the template that is then used to make mRNA in a reaction - called in vitro transcription-that takes place a test tube. Because a lot of DNA template is used for this reaction it must be removed/digested to get a clean mRNA product.
In the case of proteins/peptides manufacturing , a small amount of plasmid DNA is introduced into bacteria or yeast or whatever cells to make a lot of the protein. The DNA is not amplified- or enriched like it is for when making mRNA vaccines. You don’t generate large quantities of DNA when making peptides/proteins. And also the method of purifiying proteins does not result is as much contaminating DNA as when you make mRNA.
In both cases the term recombinant DNA technology is used because both rely on engineering a DNA template before the actual manufacturing of the products. In the case of mRNA vaccines a you’re making recombinant DNA that encodes for the spike gene or whatever target gene your mRNA is supposed to encode. For peptides/proteins you’re making recombinant DNA that encodes for the peptide.
How the recombinant DNA is used downstream in manufacturing is different and therefore the downstream safety considerations are also wildly different
@jeffreytucker This review js nothing more than a propaganda piece in a high profile journal-the Lancet?
The authors are a veritable who’s who of pharma COI. Checkout the Declarations of Interests section at the end of the paper. Simply amazing !!
@LocasaleLab You mean like this propaganda piece that just came out in the Lancet?
The authors are a veritable who’s who of pharma COI. Checkout the Declarations of Interests section at the end of the paper. Simply amazing !!