Contamination biologique des produits pharmaceutiques : Oh non !
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Biological Contamination of Pharmaceuticals: Oh No
Story at-a-glance
- Biological contamination of pharmaceutical products and hospital-acquired infections are not uncommon but they rarely get the massive attention they deserve
- Pharmaceutical giants regularly recall their products due to contamination — and that is just when they get “caught”
- In 2012, a multistate outbreak of fungal meningitis was linked to contaminated steroid injections; a compounding pharmacy in Massachusetts was blamed
- In 2021, David Stonebrook filed a lawsuit, alleging unsanitary conditions at the facilities where they packaged components used in the production of Pfizer and Moderna COVID vaccines
- Under the “new normal, due to apathy and overall decline, the real-life sanitary standards are getting worse”
Degradation of Standards
Signs of emotional and physical decay are everywhere, especially in the previously glamorous cities like New York. Apathy and indignity come with a decline in basic sanitary standards and hygiene. One would think that obsessive mask wearing would be accompanied by impeccable hygiene — but no. It has been my observation that paradoxically, during the times of "COVID," business sanitary conditions — imperfect even prior to 2020 — took a major nose dive.
I have seen first-hand a New York pharmacy employee sorting out a pile of new arrivals (reading glasses, etc.) on the dirty aisle floor. I have also witnessed different cashiers at yet another pharmacy clean up the trash cans and then proceed to check out purchases wearing the same gloves, to the soundtrack of various Pfizer commercials for vaccines.
Methinks that the "microbiome" from New York trash is not exactly what our bodies crave for optimum health — but hey, it’s just me.
Hospital-Acquired Fungal and Other Infections
Hospital-acquired fungal and other infections are not anything new. They have been a major contributor to the iatrogenic harms for years now. According to a paper published in the Journal of Patient Safety ten years ago, in 2013, "a lower limit of 210,000 deaths per year was associated with preventable harm in hospitals.
Given limitations in the search capability of the Global Trigger Tool and the incompleteness of medical records on which the Tool depends, the true number of premature deaths associated with preventable harm to patients was estimated at more than 400,000 per year. Serious harm seems to be 10- to 20-fold more common than lethal harm."
When a number of hospitals in America were rated by Consumer Reports based on the number of infections they reported, it was found that large teaching hospitals in big cities rated worse than smaller ones.
Here is a curious fact. This now-deleted article, published by MSN in 2021 and titled, "Killer fungus spread rampantly at US hospital Covid ward," discussed Candida auris infections in patients in a Florida COVID ward:
"C. auris is associated with up to 40 percent in-hospital mortality and is usually caught inside healthcare settings, especially when people have feeding or breathing tubes, or catheters placed in large veins.
It causes bloodstream, wound and ear infections and has also been found in urine and respiratory samples, but it's not clear if the fungus actually infects the lung or bladder. The recent outbreak began in July when a hospital — which the report did not name — notified the Florida Department of Health of an initial four cases of the fungus among patients being treated for the coronavirus.
The next month, the hospital carried out additional screening in its Covid-19 unit, which spanned four floors across five wings, and identified 35 more patients as being C. auris-positive. Follow-up data was available for only 20 out of the 35 patients."
The numbers in the study are small but the implications are potentially very significant. That particular hospital happened to test the patients in their COVID ward for the fungus and acknowledge their fungal infections. How many hospitals forgot (or "forgot") to do that?
And how about the mainstream claim that bacterial pneumonia might have caused a large percentage of "COVID" deaths? How about that? Is anyone going to apologize for the massive 2020 fear mongering, or was this claim allowed because they — the "they" — are about to push a different kind of vaccines and are preparing the scene?
Today, the official take on drug-resistant fungal and other infections in healthcare facilities is that they are very much on the rise. (Even the CDC says so.) But what caused them to be on the rise?
What impaired the natural ability of the westerners to resist infections? Was is mainly the overuse of antibiotics — like they say — or could it be that the entire model of Rockefeller sickcare is simultaneously crumbling under its own weight and doing exactly what it was supposed to do, i.e. turning innocent would-be healthy people into desperate patients for life?
Ironically, this 2018 paper half-answers the question about the rise in fungal infections and almost says the quiet part out loud (the HIV claim aside): "Fungal diseases became a major medical problem in the second half of the 20th century when advances in modern medicine together with the HIV epidemic resulted in large numbers of individuals with impaired immunity [emphasis mine]." Don’t you say!
Download this Article Before it Disappears
Download PDF2012 Multistate Fungal Meningitis Outbreak Linked to Contaminated Steroids
Remember the 2012 multistate outbreak of fungal meningitis that was linked to contaminated steroid injections? In that particular outbreak, about 800 people in twenty states were officially diagnosed with fungal meningitis, and more than a hundred people died.
As a result of the formal investigation, Gregory Conigliaro, the former co-owner of a Massachusetts compounding pharmacy implicated in the multistate fungal meningitis outbreak in 2012, was sentenced to one year in prison and one year of supervised release.
"Prosecutors said Conigliaro conspired with a fellow co-owner — the company’s head pharmacist — to misrepresent the company’s operating procedures to the US Food and Drug Administration and a state pharmacy registration board …
The head pharmacist, Barry Cadden, was sentenced to nine years prison in 2017, having been convicted of racketeering, racketeering conspiracy, mail fraud and introduction of misbranded drugs into interstate commerce with the intent to defraud and mislead."
In the case of the 2012 meningitis outbreak, they found the guilty parties — who weren’t any kind of "big names" — and sentenced them to jail. All fixed now? Shall we believe that the problem of contaminated injectable products has been limited to some compounding pharmacy, and nothing like that could ever happened again?
Mold Contamination in the Production of Pfizer and Moderna COVID Vaccines? David Stonebrook’s Lawsuit
In in 2021, David Stonebrook filed a lawsuit against Merck KGaA (Darmstadt, Germany), Sigma-Aldrich Corp., EMD Millipore, and Research Organics, LLC, alleging unsanitary conditions at the facilities where they packaged some of the components used in the production of Pfizer and Moderna COVID vaccines. (Here is the amended complaint from 2023.)
According to Stonebrook’s lawsuit, he was hired as GMP ("Good Manufacturing Practices") Packaging Supervisor at the defendants’ facility in Cleveland, Ohio, where he oversaw the packaging of TRIS and HEPES (buffers used in protein production and purification) from supersacks that hold several tons of product into smaller packaging for shipment. He was employed at the Facility as "GMP Packaging Supervisor" from January 4, 2021 to March 3, 2021.
Stonebrook was allegedly "informed by the management and reviewed documents reflecting that TRIS and HEPES manufactured and packaged at the Facility were intended for use in the Pfizer and Moderna Covid-19 vaccines."
According to his complaint, he subsequently "observed that the conditions in these packaging rooms where TRIS and HEPES were being repackaged at the Facility do not comply with GMP standards, including because the air handling and dust collection systems servicing these rooms were highly contaminated with mold, other contaminants, and residue from other components packaged in those rooms.
This posed a serious danger to patient health and also plainly violated the obligations that Pfizer and Moderna had to provide GMP compliant Covid-19 vaccines to the United States government."
Stonebrook made "numerous attempts to bring these serious issues to the attention of Defendants’ management, including initially in discussions, and then in writing. Defendants, instead of correcting these serious issues, fired him." Here are some images from Stonebrook’s complaint:
Stonebrook’s lawsuit is pending (seemingly in mediation now). In 2023, the defendants in his lawsuit seem to have filed a counter lawsuit against him (defamation, contract breach, etc.).
J&J’s History of Mold and Other Contamination of Drugs and Vaccines
According to NBC News, in 2021, the FDA told Johnson & Johnson to "discard about 60 million doses of its Covid-19 vaccine that were produced at a troubled plant in Baltimore." The FDA inspection of the Baltimore facility "revealed it had serious problems with unsanitary conditions and had failed to properly train workers." One of the problems reported was mold.
In relation to the J&J troubles, Fox Business reported that Emergent BioSolutions, the company at the center of the vaccine supply chain, had been previously "cited repeatedly by the Food and Drug Administration for problems such as poorly trained employees, cracked vials and mold around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act."
In 2010, Johnson & Johnson recalled multiple batches of "big-selling, over-the-counter medicines after customers complained about odors of mold and mildew coming from the packages." The recalled products included a wide variety of Tylenol and Motrin painkillers, Rolaids antacids, St. Joseph aspirin, and Benadryl allergy tablets. According to FDANews, in 2010, both J&J and Pfizer "recalled major drugs for musty, moldy odor."
In 2013, J&J recalled 5,000 vials of Risperdal Consta, a long-acting injectable version of the antipsychotic pill Risperdal. A routine analysis "revealed that one lot of the med was contaminated with a mold found commonly in the environment."
"That recall followed close behind another from J&J's McNeil Consumer Healthcare unit. After finding plastic particles in its API last week, the company pulled 200,000 bottles of Motrin Infants' Drops."
In 2014, J&J recalled 13,500 bottles of Xarelto because of contamination. "According to a recall notice in the latest FDA Enforcement Report, the drugmaker said that it confirmed that a sales sample of the drug was contaminated after a customer complaint, and so initiated a nationwide, voluntary recall. The company reported that the product came from a plant in Gurabo, Puerto Rico."
"Brought to You by Pfizer"?
In 2019, Pfizer recalled two lots of Relpax, a headache medicine that narrows blood vessels around the brain, due to the "potential presence of Genus Pseudomonas and Burkholderia ... Individuals who consume oral products contaminated with microorganisms are at risk of bacterial dissemination from the gut to the bloodstream potentially resulting in serious, life-threatening infections."
Mycoplasma Contamination of Vaccines
Here is a highly censored talk by Dr. Garth Nicolson in which he discusses potential mycoplasma contamination of vaccines. I am sharing with great thanks to A Midwestern Doctor for posting this video as the last time I looked, it had been completely scrubbed from YouTube.
Contaminated Rotarix Vaccines?
Here is a very interesting excerpt by John Stone published by Age of Autism:
"On March 22, 2010 the FDA suspended the use of GSK’s Rotarix vaccine after it was found to be contaminated with porcine circovirus type 1 (PCV-1). Then on May 6 the Offit/Merck version Rotateq was found to be contaminated not only by PCV-1 but another related virus, porcine circovirus type 2 (PCV-2).
On May 7, according to information on the FDA website a meeting was swiftly convened: ‘to discuss the findings of PCV and PCV DNA in rotavirus vaccines. Based on a careful evaluation of this information, a thorough review of the scientific literature, and input from scientific and public health experts, the Agency is revising its recommendation to temporarily suspend use of the Rotarix vaccine.
FDA has determined it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.’"
Putting the Plasmid Contamination in Context
Like I said in an earlier Substack article, I would like to put the plasmidgate and the SV40 contamination of COVID injections in a broader context. The plasmid contamination is a very bad thing — and my hat goes off to every brave soul who is exploring that route.
"However, the problem is much bigger, in my opinion, and it is very helpful to zoom out and consider the fact that biological contamination of the things that we presume to be clean is very widespread.
And while it is very widespread — and we are exposed to a ton of natural and genetically modified bugs — due to poisoning of everything, our microbiomes and our immune systems are not "what they used to be." So it’s a bit of a double whammy. And yet, our job is to prevail!"
Precision Fermentation
Then we have the so called "precision fermentation" which is playing an increasingly significant role in the production of pharmaceutical components, popular food additives, etc.
It is not really fermentation per se, it’s a technology that "uses microorganisms – usually genetically modified – as ‘cell factories’ to produce specific functional ingredients," such as, for example, proteins and enzymes. The technology is considered cost-effective by the pharmaceutical, food, and other industries, and it is on the rise.
Once the target components are produced, they are supposed to be separated from the biological "goo" that’s produced them and thoroughly purified. How well are they separated and purified?
In theory, it all works great — but this particular peasant is feeling a little skeptical about the "quality assurance" process across the board and thinks that the problem of biological contamination of everything is going to become even bigger as precision fermentation is used more.
Hey, in no relation to precision fermentation, in 2013, Boehringer Ingelheim closed a whole pharmaceutical plant in Bedford, OH, following 2011 failed inspections that revealed unsanitary conditions, including the famous bucket of urine! Do you think that the spirit of "warp speed" moneymaking made things any better? Methinks, no.
A Prediction
Here is my prediction:
"We are going to hear more and more about drug-resistant non-viral infections running amok. It will be presented as a big surprise, despite the WEF writing for years about antimicrobial resistance being the next big threat. There will be cries for new drug development and new life-saving vaccines, this time against molds, yeasts, and intracellular parasites.
We are going to hear more about "dementia" being caused by microbes. Hell, they may even dare squeak that "autism" can be caused by microbes — and they are going to wrap this in a war cry for more vaccines.
It will be all very cruel because neurological issues can be caused by microbes and, in my opinion, often are — in part due to injecting very lucky microbes into children’s arms and bloodstreams for decades — but one thing that is definitely not going to help those children (now senior citizens with dementia) is more potentially contaminated vaccines."
Conclusion
I would like to end the story with a few philosophical and practical thoughts:
"I believe that a lot of "mysterious" sickness that has been exploding over the past decades (including skyrocketing dementia and autism) can be attributed not just to the all-pervasive business model based on ruthless poisoning — but also to the under-the-radar microbes, such as molds and other fungi, protozoans, not-so-friendly bacteria, and other living creatures who are very prevalent in the westerners’ bodies but capitalize on the myth of cleanliness in the westerners’ minds.
Those bugs can lie low for a long time and then attack in earnest when the person gets old, overly stressed, overly poisoned or irradiated, gets another infection, etc." This is not a reason for panic. It’s a call for exploring, protecting ourselves intelligently and fearlessly — and giving our bodies the love we deserve.
"When it comes to vaccines, the unsanitary abyss offers a unique way to harm. If a biologically contaminated substance is injected into one’s arm, the contamination can very easily get straight into the bloodstream, bypassing the body’s natural guards.
Furthermore, in case of COVID mRNA vaccines, they are immunosuppressive by design to prevent the body from nuking the foreign genetic material — and so if a lucky bug is accidentally injected straight into the bloodstream alongside immunosuppressive components — that is one lucky bug!"
"In next few years, the amount of people who can productively work and use their bodies and brains in the "old normal way" will likely significantly decrease. Now is a very good time for soul searching, exploring and learning the old ways of medicine, and remembering that there is a meaning to all this."
There is definitely existential meaning to everything we are going through — including the abysmal decline of mainstream medicine — and my hope is that as the Rockefeller sickcare crumbles — we will find our connection to earth, to better medicine, to each other, and to our own souls.
About the Author
To find more of Tessa Lena's work, be sure to check out her bio, Tessa Fights Robots.
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