Regulatory Capture and the Pharmaceutical Industry

 

I was leafing through a book and discovered an article from 2008 that I had cut out and saved in its pages. The article is salient to the problem of regulatory capture, which I've written about extensively - e.g., see here

In the article excerpted below, FDA employees were challenging their organization's stance that agency drug labels pre-empt state laws, thereby blocking consumer lawsuits against hazardous drugs:

Mundy, Alicia (2008, October 30). FDA Memos Undercut Stance on Pre-Empting Drug Suits. The Wall Street Journal, p. A3.

Career officials at the Food and Drug Administration objected to the FDA blocking consumer lawsuits against drug makers in the past few years, according to agency documents released Wednesday in a congressional investigation.

...The FDA wants the high court to pre-empt lawsuits in state court over problems with federally regulated drugs.

Two officials said in the memos it is wrong to assume that FDA-approved drug labels are completely reliable, or that they are based on full disclosure of safety risks by drug makers.

'Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA approving labeling is fully accurate and up-to-date in a real time base,' wrote John Jenkins, the top official in the drug approval section, in 2003. At that time, the FDA was debating a rule, later adopted, that enshrined the concept of pre-empting state suits....  

The current debacle with the mRNA vaccine hazards illustrates regulatory capture by corporate interests at an unprecedented scale, as I discuss here. For example, a recent article provides evidence that the FDA accelerated mRNA vaccine approval in order to enable vaccine mandates. 

Whistleblowers within FDA and other organizations involved in testing and approval processes spoke up but they were steamrolled, marginalized, expelled and dismissed. See here: https://www.bmj.com/content/375/bmj.n2635

The machine that is the FDA/CDC complex tolerates no dissent under conditions of regulatory capture.

Furthermore, as illustrated by the unethical mandates, we have entered a new era where regulatory capture not only greases approval of products with undetermined safety issues, but also requires populations to be subjected to them, regardless of their need or willingness.

As I posted recently, we have entered an era of Pay to Play on Pharmed Humans.

People are waking up to this travesty of justice but institutional change demands (peaceful) institutional accountability starting with full transparency.

 

Studies Find Natural Immunity to COVID-19 Far Superior to Vaccine Induced Immunity

 

Dr. John Campbell reviews this study, which like the Cleveland Clinic Study [doi: https://doi.org/10.1101/2021.06.01.2125817], finds natural immunity to be far superior in efficacy and durability to vaccine induced immunity:

Gazit, S. et al., (2022). Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Naturally Acquired Immunity versus Vaccine-induced Immunity, Reinfections versus Breakthrough Infections: A Retrospective Cohort Study. Clinical Infectious Diseases, 75(1), doi.org/10.1093/cid/cia262

 

                                        https://youtu.be/IiA1S6NvCo4?si=dsR2rbq9wRyH-ByK

The findings of this study that natural immunity is 27 times superior to vaccine induced immunity raises important questions regarding the rationale for US CDC recommendations that everyone be re-vaccinated.

I've written quite extensively about the hazards with the current vaccination regime. See my last post here: http://majiasblog.blogspot.com/2023/09/hazards-of-mrna-vaccine-platform.html

I've been studying the various narratives that circulate across print and social media regarding the rationale for pushing the vaccines. These narratives include:

ECONOMIC/COMMERCIAL NARRATIVE:  Narrative holds that US and other nations' regulatory agencies are captured by commercial interests and policy is therefore driven by greed rather than public health. Biden's bid to create a new economic boom in the bio-economy is linked to this narrative.

GEOPOLITICAL NARRATIVE: Narrative holds that geopolitical conflict between China and the US are manifesting in viral bio-warfare and the vaccines are military counter-measures deployed in lock-step formulation without consideration of new evidence of risk-benefit ratios.

POPULIST NARRATIVE: Narrative holds that the Club of Rome dystopic type scenarios of global over-population are driving elite efforts to de-populate the earth, especially developed nations, using vaccines that have hidden impacts on fertility as imagined in the British version of the Utopia series.

 

There may be other foundational narratives but these are the most dominant ones I've encountered. Each offers an explanation for the irrational unwillingness to confront vaccine induced injuries and to incorporate efficacy data other than produced by the vaccine manufacturers themselves.

Trailer for UK British Utopia Series

 

Hazards of mRNA Vaccine Platform Reviewed

50% of my household suffered severe adverse events from the Moderna vaccine. I only got the vaccine because I was threatened with being fired. See my post here:http://majiasblog.blogspot.com/2021/12/this-is-not-disinformation-lot-030b21a.html

The consequences for our compliance with this extortion haunt us today.

Moreover, we know many, many people who suffered auto-immune disease conditions after taking mRNA vaccines. We also know of two people who died from their "vaxxes." I've reviewed the failed cost-benefit analysis previously at this blog.

I have spent the last 3 years trying to understand what happened. I've learned that there are at least 4 known problems with the mRNA platform:

• The spike protein payload
• The lipid "nanoparticle" delivery system
• The synthetic mRNA - N1-methylpseudouridine used in mRNA
•  Contaminants/Adulterants 
  

Spike protein is dangerous in and of itself. Lipid nanoparticle encased instructions for your body engineering spike can persist for an unknown length of time and get distributed across your body and bioaccumulate in organs!  Worse - the lipid nanoparticles are themselves highly toxic!

LIPID NANOPARTICLE DELIVERY SYSTEM

I highly recommend the informative video here regarding nature and hazards of lipid nanoparticles used in mRNA vaccinations by Dr Robert Malone, whose work with mRNA makes him a very legitimate authority on this subject:

https://open.substack.com/pub/rwmalonemd/p/lipid-nanoparticles-a-regulatory?r=q89bo&utm_campaign=post&utm_medium=web

RELATED RESEARCH

Parhiz, H. et al., (2022). Added to pre-existing inflammation, mRNA-lipid nanoparticles induce inflammation exacerbation (IE). Journal of Controlled Release, 344, 50-61.

Current nucleoside-modified RNA lipid nanoparticle (modmRNA-LNP) technology has successfully paved the way for the highest clinical efficacy data from next-generation vaccinations against SARS-CoV-2 during the COVID-19 pandemic. 

However, such modmRNA-LNP technology has not been characterized in common pre­ existing inflammatory or immune-challenged conditions, raising the risk of adverse clinical effects when administering modmRNA-LNPs in such cases. 

Herein, we induce an acute-inflammation model in mice with lipopolysaccharide (LPS) intratracheally (IT), 1 mg kg-1, orintravenously (IV), 2 mg kg-1, and then IV administer modmRNA-LNP, 0.32 mg kg-1, after 4 h, and screen for inflammatory markers, such as pro­ inflammatory cytokines. ModmRNA-LNP at this dose caused no significant elevation of cytokine levels in naive mice. 

In contrast, shortly after LPS immune stimulation, modmRNA-LNP enhanced inflammatory cytokine responses, Interleukin-6 (IL-6) in serum and Macrophage Inflammatory Protein 2 (MIP-2) in liver significantly. 

Our report identifies this phenomenon as inflammation exacerbation (IE), which was proven to be specific to the LNP, acting independent of mRNA cargo, and was demonstrated to be time- and dose-dependent. Macrophage depletion as well as TLR3 -/- and TLR4-/- knockout mouse studies revealed macrophages were themmune cells involved or responsible for IE. Finally, we show that pretreatment with anti-inflammatory drugs, such as corticosteroids, can partially alleviate IE response in mice. Our findings characterize the importance of LNP­ mediated IE phenomena in gram negative bacterial inflammation, however, the generalizability of modmRNA­ LNP in other forms of chronic or acuteinflammatory and immune contexts needs to be addressed.

SYNTHETIC mRNA 

According to a 2020 study (doi.org/10.1105/tpc.19.00639) the biological relevance of pseudouridine in mRNA remains unclear so downstream effects are not yet mapped:

Mingjia Chen , Claus-Peter Witte, A Kinase and a Glycosylase Catabolize Pseudouridine in the Peroxisome to Prevent Toxic Pseudouridine Monophosphate Accumulation, The Plant Cell, Volume 32, Issue 3, March 2020, Pages 722–739, https://doi.org/10.1105/tpc.19.00639 

This same study observes a risk of toxicity from pseurdouridine: Compromising pseudouridine catabolism leads to strong pseudouridine accumulation and increased ΨMP content. ΨMP is toxic, causing delayed germination and growth inhibition. More Research Needed to Assure Safety, Especially with Cumulative Exposures. 

SPIKE PROTEIN PAYLOAD ISSUES

Scientists from the Salk institute that found that the spike protein alone, in the absence of the rest of the virus, can cause damage to endothelial cells? Here is the citation and the link to the press release for your reference

SARS-CoV-2 Spike Protein Impairs Endothelial Function via Downregulation of ACE 2
Yuyang Lei , Jiao Zhang , Cara R. Schiavon, Ming He, Lili Chen, Hui Shen, Yichi Zhang, Qian Yin , Yoshitake Cho , Leonardo Andrade , Gerald S. Shadel , Mark Hepokoski, Ting Lei, Hongliang Wang, Jin hang, Jason X.-J. Yuan, Atul Malhotra, Uri Manor, Shengpeng Wang, Zu-Yi Yuan, John Y-J. Shyy Originally published31 Mar 2021https://doi.org/10.1161/CIRCRESAHA.121.318902Circulation Research. 2021;128:1323–1326

Another study finds that the spike protein, detached from the rest of the virus, elicits cell signalling in human cells, which "may promote pulmonary vacular remodeling and PAH [pulmonary arterial hypertension] as well as other cardiovascular complications":

Yuichiro J. Suzuki1,* and Sergiy G. Gychka SARS-CoV-2 Spike Protein Elicits Cell Signaling in Human Host Cells: Implications for Possible Consequences of COVID-19 Vaccines. Vaccines 2021, 9(1), 36; https://doi.org/10.3390/vaccines9010036

CONTAMINANTS

Dr. Malone, in the video linked above, explains how failures in mRNA vaccine manufactoring are resulting in concerning DNA contamination. The production process is not "clean," as an example from Japan illustrates.

August 28, 20213:38 Two die in Japan after shots from suspended Moderna vaccines - Japan govt Reuters https://www.reuters.com/business/healthcare-pharmaceuticals/two-die-japan-after-shots-suspended-moderna-vaccines-japan-govt-2021-08-28/

TOKYO, Aug 28 (Reuters) - Two people died after receiving Moderna Inc (MRNA.O) COVID-19 vaccine shots that were among lots later suspended following the discovery of contaminants, Japan's health ministry said on Saturday.

 

RELATED POSTS

http://majiasblog.blogspot.com/2022/05/mrna-vaccines-linked-to-higher-cardio.html

http://majiasblog.blogspot.com/2022/04/fda-shuts-out-its-own-experts-in.html

http://majiasblog.blogspot.com/2022/03/thanatopolitics-and-vaccine-apartheid.html

http://majiasblog.blogspot.com/2021/08/what-is-going-on-no-public-health.html

http://majiasblog.blogspot.com/2021/06/spike-protein-blues.html

http://majiasblog.blogspot.com/2021/06/approval-mandatory-vaccine-mandates-for.html