WAR, PANDEMICS, CLIMATE AND... NANO-INJECTABLES
SAFE AND EFFECTIVE AREN'T GOING ANYWHERE
NANO-VACCINE FATIGUE?
NOT IN DAVOS!
https://www.youtube.com/watch?v=cyX0hxJX5N4 100 days to outrace the next pandemic | Davos 2023 - YouTube
MEANWHILE, A NUCLEAR CONFRONTATION IS APPROACHING AND.... MORE NANO-VACCINES!
17 January 2023 Directorate-General for European Civil Protection and Humanitarian Aid Operations (ECHO)
The Commission is allocating today €242 million to Finland for the development of the first rescEU chemical, biological, radiological and nuclear (CBRN) strategic reserve.
The Commission has already set up rescEU reserves for different areas across other EU Member States, such as the rescEU forest fighting airfleet (Croatia, France, Greece, Italy, Spain, and Sweden in 2022) and the rescEU medical stockpile of protective equipment and devices (Belgium, Croatia, Denmark, Germany, Greece, Hungary, Romania, Slovenia, Sweden, and The Netherlands).
The CBRN strategic reserve is part of the development of an EU-level stockpiling approach of medical countermeasures to be used in health emergencies. It is established in the framework of the strengthened EU Civil Protection Mechanism and further elaborated with the health Emergency Preparedness and Response Authority (HERA).
This new reserve is the first dedicated to CBRN equipment. It will include critical medical countermeasures, such as
VACCINES
and antidotes, medical devices and field response equipment to ensure better protection and response in the aftermath of CBRN events or in preparation for high-risk situations.
Amidst Russia's war of aggression against Ukraine, the EU has provided Ukraine with CBRN and medical assistance worth more than €50 million, including:
medical countermeasures (antidotes, potassium iodide tablets, bronchodilators, and other therapeutics)
medical devices (oxygen concentrators and other intensive care unit equipment)
and response equipment (e.g., decontamination, personal protective equipment, and chemical detectors).
Last week, the EU also mobilised its rescEU medical reserves to support Ukraine.
Medical stocks hosted by Greece, Germany, and Sweden are currently being deployed to provide life-saving aid to Ukraine. The supplies, valued at over €13 million, include medicines, medical equipment, and protective gear including against chemical, biological, radiological and nuclear threats.
https://www.iaea.org/newscenter/pressreleases/update-143-iaea-director-general-statement-on-situation-in-ukraine Update 143 – IAEA Director General Statement on Situation in Ukraine | IAEA
They also continued their discussions on a proposal by Director General Grossi to set up a nuclear safety and security protection zone around the Zaporizhzhya Nuclear Power Plant (ZNPP). Europe’s largest nuclear power plant (NPP) has repeatedly come under fire in recent months, triggering deepening nuclear safety and security concerns. “This major nuclear power plant continues to face daily dangers. Our team there continues to hear explosions close to the site, including two on Thursday,”
https://www.nbcnews.com/health/health-news/us-purchase-radiation-sickness-drug-nplate-no-cause-alarm-rcna51252 Why U.S. purchase of radiation sickness drug Nplate is no cause for alarm (nbcnews.com)
Amid concerns about Russian President Vladimir Putin’s recent nuclear threats came a bit of startling news: The U.S. Department of Health and Human Services said Tuesday that it spent $290 million on a drug to treat radiation sickness.
The department said in a statement that the purchase of the drug, called Nplate, is part of its “long-standing, ongoing efforts by the Administration for Strategic Preparedness and Response to better prepare the U.S. for the potential health impacts of a wide range of threats to national security.”
Nplate, manufactured by U.S. drugmaker Amgen, was approved by the Food and Drug Administration in 2021 to treat injuries caused by acute radiation syndrome, also known as radiation sickness. (It was also approved in 2008 to treat an autoimmune disorder that causes excessive bleeding.)
https://aspr.hhs.gov/newsroom/Pages/ARS-Oct2022.aspx HHS purchases drug for use in radiological and nuclear emergencies
Amgen, based in Thousands Oaks, California, developed Nplate for ARS with support from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Administration for Strategic Preparedness and Response (ASPR), as well as the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
BARDA is using its authority provided under the 2004 Project Bioshield Act and $290 million in Project BioShield designated funding to purchase this supply of the drug.
To reduce radiation-induced bleeding, Nplate stimulates the body’s production of platelets. The drug can be used to treat adults and children.
Nplate is also approved for adult and pediatric patients with immune thrombocytopenia, a blood disorder resulting in low platelet counts.
Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products – needed to combat health security threats.
Nplate (Romiplostim)
Radiation sickness leads to a problem in the bone marrow in which people cannot make new platelets (the cell fragments that help a person clot). The Food and Drug Administration (FDA) approved Nplate in January 2021 as an agent that increases platelet counts, helping to reduce radiation-induced bleeding.
The injection medicine is used in children and adults, and it should be given as soon as possible after exposure to high levels of radiation.
https://pubmed.ncbi.nlm.nih.gov/31021662/ Romiplostim (Nplate®) as an effective radiation countermeasure to improve survival and platelet recovery in mice
Results: Full or maximal efficacy with an ∼40% increase in survival was achieved after a single 30 µg/kg dose of romiplostim. No further survival benefit was seen with higher (100 µg/kg) or more frequent dosing (3 or 5 once daily doses at 30 µg/kg) of romiplostim or combined treatment with pegfilgrastim.
WHILE:
https://www.researchgate.net/publication/317570419_Evaluation_of_Radio-Protective_Effects_of_N-Acetylcysteine_on_Radiation-Induced_Lethality_in_Mice Evaluation of Radio-Protective Effects of N-Acetylcysteine on Radiation-Induced Lethality in Mice
The percentage of survival after 30 days was 46.2% for the irradiation group.
In addition, the percentage of decreased lifespan was calculated at 5.90%, 23.60% and 17.93% for the first-third groups, respectively. Conclusion Results revealed lack of effectiveness of treatment with NAC after lethal dose. These results suggested that application of NAC for mice before irradiation protected them from the lethal effects of whole-body irradiation. (!!!!!!!!!)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2800038/ ANTIOXIDANTS REDUCE CONSEQUENCES OF RADIATION EXPOSURE
“For example, melatonin has been shown to augment the activity of glutathione peroxidase in addition to stimulating the activity of glutathione reductase and increasing the synthesis of glutathione (GSH); all of which are important in reducing levels of oxygen radicals and peroxides in cells.
NAC demonstrated similar effects to those observed for WR-1065 [the most effective was WR-2721 or amifostine, a sulfhydryl prodrug activated by alkaline phosphatase to the active WR-1065] with respect to increasing cell survival.
It is known that the active form of vitamin E in membranes is maintained through reactions with ascorbic acid.
http://www.bcc.bas.bg/BCC_Volumes/Volume_51_Special_A_2019/E-pdf-ready/BCC-51-A-2019-276-282-Karamalakova-E8%20ready.pdf High-level gamma radiation effects on radical-scavenging activity of black chokeberry (Aronia melanocarpa) ethanol extract
CONCLUSION In conclusion current results show that used A. melanocarpa extract demonstrate well-expressed DPPH radical scavenging ability, SOD-like activity and radio-protective capabilities before and at 10 kGy irradiation. Chain-breaking antioxidant activity of lipid soluble components decreases with increasing the irradiation dose.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125268s172lbl.pdf
Progression from myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML) has been observed in adult clinical trials with Nplate.
A randomized, double-blind, placebo-controlled trial enrolling adult patients with severe thrombocytopenia and International Prognostic Scoring System (IPSS) low or intermediate-1 risk MDS was terminated due to more cases of AML observed in the Nplate arm. This trial consisted of a 58-week study period with a 5-year long-term follow-up phase. The patients were randomized 2:1 to treatment with Nplate or placebo (167 Nplate, 83 placebo).
During the 58-week study period, progression to AML occurred in 10 (6.0%) patients in the Nplate arm and 4 (4.8%) patients in the placebo arm (hazard ratio [95%CI] = 1.20 [0.38, 3.84]). Of the 250 patients, 210 (84.0%) entered the long-term follow-up phase of this study. With 5-years of follow-up, 29 (11.6%) patients showed progression to AML, including 20/168 (11.9%) patients in the Nplate arm versus 9/82 (11.0%) patients in the placebo arm (HR [95% CI] = 1.06 [0.48, 2.33]). The incidence of death (overall survival) was 55.7% (93/167) in the Nplate arm versus 54.2% (45/83) in the placebo arm (HR [95% CI] = 1.03 [0.72, 1.47]). In the baseline low IPSS group, there was a higher incidence of death in the Nplate arm [41.3% (19/46)] compared to the placebo arm [30.4% (7/23)] (HR [95% CI] = 1.59 [0.67, 3.80]). In a single-arm trial of Nplate given to 72 patients with thrombocytopenia-related MDS, 8 (11.1%) patients were reported as having possible disease progression, of which 3 (4.2%) had confirmation of AML during follow-up. In addition, in 3 (4.2%) patients, increased peripheral blood blast cell counts decreased to baseline after discontinuation of Nplate. Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than ITP.
The safety profile of Nplate was similar across patients, regardless of ITP duration. The following adverse reactions (at least 5% incidence and at least 5% more frequent with Nplate compared with placebo or standard of care) occurred in Nplate patients with ITP duration up to 12 months: bronchitis, sinusitis, vomiting, arthralgia, myalgia, headache, dizziness, diarrhea, upper respiratory tract infection, cough, nausea and oropharyngeal pain. The adverse reaction of thrombocytosis occurred with an incidence of 2% in adults with ITP duration up to 12 months.
Bone Marrow Reticulin Formation and Collagen Fibrosis Nplate administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate therapy.
• Erythromelalgia • Hypersensitivity reactions including angioedema and anaphylaxis
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
Pregnancy Risk Summary Based on findings from animal reproduction studies, Nplate may cause fetal harm when administered to a pregnant woman. Available data with Nplate use in pregnant women are insufficient to draw conclusions about any drugassociated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction and developmental toxicity studies, romiplostim crossed the placenta, and adverse fetal effects included thrombocytosis, postimplantation loss, and an increase in pup mortality. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
The carcinogenic potential of romiplostim has not been evaluated. The mutagenic potential of romiplostim has not been evaluated.
In a 4-week repeat-dose toxicity study in which rats were dosed subcutaneously three times per week, romiplostim caused extramedullary hematopoiesis, bone hyperostosis, and marrow fibrosis at clinically equivalent and higher doses. In this study, these findings were not observed in animals after a 4-week post treatment recovery period. Studies of long-term treatment with romiplostim in rats have not been conducted; therefore, it is not known if the fibrosis of the bone marrow is reversible in rats after long-term treatment.
The safety and efficacy of Nplate in adults with ITP were assessed in two double-blind, placebo-controlled clinical studies, an open-label single-arm study, and in an open-label extension study. Studies 1 (NCT00102336) and 2 (NCT00102323)
Study 3 (NCT01143038) Study 4 (NCT00116688) Extension Study Study 5 (NCT01444417) Study 6 (NCT00515203) Study 7 (NCT02279173) Long-Term Pediatric Study
Efficacy studies of Nplate could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Approval for this indication was based on efficacy studies conducted in animals, Nplate’s effect on platelet count in healthy human volunteers and on data supporting Nplate’s effect on thrombocytopenia in patients with ITP and insufficient response to corticosteroids, immunoglobulins, or splenectomy. Because of the uncertainty associated with extrapolating animal efficacy data to humans, the selection of a human dose for Nplate is aimed at providing platelet response to Nplate that is similar to that observed in efficacy studies conducted in animals.
http://web.archive.org/web/20210510205501/https://www.shenterprise.in/product/nplate/Nplate - S. H. Enterprise (archive.org)
Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
https://www.clinicalkey.com/#!/content/book/3-s2.0-B9780444537171015432 Thrombopoietin and thrombopoietin receptor agonists
J.K. Aronson MA, DPhil, MBChB, FRCP, HonFBPhS, HonFFPM, in Meyler's Side Effects of Drugs, 2016
Tumorigenicity
Romiplostim may encourage the progression of myelodysplasia to acute myeloid leukemia.
•An 85-year-old woman with thrombocytopenia, thought to be immune but actually secondary to myelodysplasia, was given romiplostim, initially 1 microgram/kg/week, increasing weekly to 10 micrograms/kg/week [27]. After 6 weeks she developed leukemic skin lesions with an extensive diffuse dermal infiltrate of blast cells, eosinophilic myelocytes, and neutrophils, with strong positivity for CD15, CD68, and myeloperoxidase and weak positivity for CD117 and CD45. The neoplastic cells were negative for CD3, CD5, CD10, CD20, CD21, CD30 and CD79a. The Ki67 positive proliferation index was 100%.
•A 65-year-old man with thrombocytopenia, thought to be immune but actually secondary to myelodysplasia, was given romiplostim weekly for 4 weeks. There was no improvement, but the bone marrow then showed a hypercellular marrow with 60–70% cellularity, increased megakaryocytes, and 3/4 reticulin fibrosis. When romiplostim had been withdrawn for 6 weeks the marrow showed myeloproliferative progression, with 90% cellularity, dysplastic megakaryocytes, granulocytosis/myeloid hyperplasia, and 4/4 reticulin fibrosis. The peripheral blood contained leukoerythroblasts, pelgeroid polymorphonuclear neutrophils, and blasts (5%) [28].
On 5 September 2011, the manufacturers, Amgen, issued a “Dear Healthcare Professional” letter, in which they wrote in the following terms:
•the available data from a randomized clinical study of patients with thrombocytopenia associated with myelodysplastic syndrome had shown an increase in the number of cases of disease progression to acute myelogenous leukemia and transient increases in blast cell counts in patients treated with romiplostim compared with placebo;
•a positive benefit to harm balance for romiplostim was established only for the treatment of thrombocytopenia associated with chronic immune thrombocytopenia [and] romiplostim must not be used in other clinical conditions associated with thrombocytopenia;
•the diagnosis of immune thrombocytopenia in adults and elderly patients should have been confirmed by the exclusion of other clinical entities presenting with thrombocytopenia; the diagnosis of myelodysplastic syndrome must have been excluded.
•a bone marrow aspirate and biopsy should normally have been done before starting treatment with romiplostim and over the course of the disease and treatment, particularly in patients over 60 years of age and those with systemic symptoms or abnormal signs, such as increased peripheral blast cells.
Hematology
Mark Kester PhD, ... Kent E. Vrana PhD, in Elsevier's Integrated Review Pharmacology (Second Edition), 2012
Immune Thrombocytopenic Purpura
Eltrombopag (small molecule receptor antagonist) and romiplostim (biologic) are two new drugs—with fundamentally different approaches to the same problem—for treatment of immune thrombocytopenic purpura. Interestingly, the two drugs were approved within months of each other in 2008. Immune thrombocytopenic purpura is an autoimmune disorder in which the body produces antibodies against platelets resulting in serious bleeding disorders (heavy menstruation, petechial rash, bruising, nosebleeds). Romiplostim is a chimeric recombinant biologic (thrombopoietin receptor agonist fused to Fc-peptide) that increases platelet production. As a biologic, romiplostim bears significant influenza side effects. Moreover, it can be too effective (producing too many platelets) with resulting thrombotic/thromboembolic complications. It has also been shown to also increase reticulin deposition in the bone marrow (with subsequent risk of fibrosis of the marrow). Eltrombopag is a new small molecule thrombopoietin receptor antagonist that also stimulates platelet production. It bears the advantage of oral administration (as opposed to subcutaneously). Themajor problem is that it has a black box warning for potential hepatotoxicity so liver enzymes should be carefully monitored. As with romiplostim, eltrombopag also has a risk of increasing reticulin deposition in marrow, as well as producing too robust a stimulation of platelets.
https://www.everydayhealth.com/drugs/nplate Using romiplostim may increase your risk of developing blood cancers, especially if you have a myelodysplastic syndrome (bone marrow failure disorder, sometimes called "preleukemia"). Talk with your doctor if you have concerns about this risk.
https://reviews.everydayhealth.com/drugs/nplate?page=1 Nplate (Romiplostim) Reviews - Page 1 | Everyday Health
…And apparently if you get off of the drug, your platelets can drop even lower than starting, which seems like it’ll backfire. So, I mean it’s better than taking steroids but there seems to be more cons than pros.
The drug should not be used if breastfeeding. Caution should be exercised when using this drug for cardiovascular patients who may develop blood clots. Caution should be exercised if the patient using this drug has liver or kidney failure. If you are pregnant or planning to become pregnant, you should inform your healthcare provider to determine the safety of the drug during pregnancy.
https://go.drugbank.com/drugs/DB05332
Thanks for the warning! The destructive insanity just keeps growing - although the disasters that they'e creating are sooooo obviously their next excuse for experimenting on what remains of life while they destroy the ability of the planet to sustain life that I wonder how many would actually believe them, in order to foolishly tolerate the experimentation with whatever the perps plan (evidently more of the same but, where possible, worse and on steroids) without fighting for their lives and those of their loved ones...
Seems they're giving their Nazis nukes, by the sound of it, and it's only that obsession with causing maximised harm that enables them to have so very many poisonous 'medicines'
I do very much like your suggested answer - short, sweet, and with 80% less profanity than I'd have used.
How about NO! Is exactly right!
These people are freaking crazy, dangerous and bored, quite frankly.
If they weren't doing it to capture us and with our money, it would be humerous.
Someone(s) need to put BHates out of his/our misery.