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Posts Tagged ‘clinical trials’

“Yippie-ki-yay, motherfucker.” http://www.imdb.com/title/tt0095016/quotes  All hail God, Jesus, Mohamed, Allah, the Pharaoh’s, Mother Nature, whom, whatever and Buddha too, as Baxter International Inc. (BAX) has launched full-scale production of a vaccine for the A/H1N1 flu virus that could be  ready for use as early as July.  http://online.wsj.com/article/BT-CO-20090612-714016.html 

We’re talking two weeks until projected availability! So much for clinical testing or knowing if it works. Novartis has announced it is ready to rock and roll of on it’s own vaccine.  Replikins’ officials say the company’s PanFLu™ vaccine is ready for clinical and a host of other pharma companies apparently have our ass covered to resist our exposure to the latest supposed freak of nature, Influenza A/H1N1.  Others can be found here at https://ahrcanum.wordpress.com/2009/06/12/vaccine-for-pandemic-h1n1-swine-flu-scientists-roll-up-sleeves/

The creator must love us humans and especially the scientists at Baxter, but in the most humble offering of advise- wake the frig up.  No way on God’s green earth could a company, not only a company with a laboratory 50 miles away from the Swine Flu ground zero outbreak, with a history of malfeasance develop a vaccine within days of receiving the “seed virus” from WHO, be ready to ramp up production of a vaccine against the H1N1 Swine Flu, and save the world from a potential catastrophic proportion of millions of sick and dead.

I was born at night, but it wasn’t last night.  The virus is allegedly a brand new strain that is targeting young and  healthy people.  The Main Stream Media would have us believe it is a never before seen intercontinental mixture of human, avian and pig viruses from America, Europe and Asia but the leading scientists of the world are calling bullshit, proving that this has been around for perhaps more than 15 years.

Various sources are reporting this new undetected virus that has occurred basically is a freak of nature that is now spreading across the world infecting thousands via human to human contact,  and glory be the pharmaceutical companies are ready with a vaccine within days of WHO announcing a Pandemic.  Oh, get a F*%)!ng grip on reality. 

How long has the AIDS virus been around?  Scientists have had years to study it;  “HIV mutates rapidly, and in the vast majority of people these antibodies cannot completely neutralize the many mutant versions of the virus present in any single person” http://www.iavi.org/research-development/Pages/is-an-AIDS-vaccine-possible.aspx  Mutant versions?  The reassortment of H1N1 and its mutations are all over the map from Gen Bank.

Some licensed vaccines, called live-attenuated vaccines, use a crippled but living version of the targeted pathogen—or disease-causing organism—to teach the immune system what it must attack to prevent infection. Such vaccines, however, cannot be developed against HIV because of concern that the crippled HIV might revert to its disease-causing form. But live-attenuated SIV vaccines have proven effective in protecting rhesus macaques from infection with SIV, providing a proof of concept for an AIDS vaccine.

SIV is the simian immunodeficiency virus- originated with monkeys and mutated to humans.  Bird Flu, Avian Flu, Swine Flu, Hong Kong Flu, Russian Flu- is it all the business of monkeying around with human lives.

First off, a virus is for all intents and purposes not a living thing so tell me how you are going to kill it?  You aren’t and neither is Baxter, Novartis, or Obama. 

You might put faith in Obama to fix everything from the auto and banking industry to health care reform, but why is he so confident in a plan for mass inoculations at this stage is when there is little proof they would be effective?

Baxter is supposed to follows a BSL3 (Biosafety Level 3) protocol to prevent cross-contamination of materials. “It was a combination of just the process itself, (and) technical and human error in this procedure,” said Baxter’s director of global bioscience communications Christopher Bona, ” when samples of H5N1 from Baxter’s Austrian labs contaminated batches of the less harmful H3N2 seasonal flu virus that it was supplying to European nations.

This is not the first time that vaccine companies have been caught distributing vaccines contaminated with deadly viruses.

In 2006 it was revealed that Bayer Corporation had discovered that their injection drug, which was used by hemophiliacs, was contaminated with the HIV virus. Internal documents prove that after they positively knew that the drug was contaminated, they took it off the U.S. market only to dump it on the European, Asian and Latin American markets, knowingly exposing thousands, most of them children, to the live HIV virus. Government officials in France went to prison for allowing the drug to be distributed. The documents show that the FDA colluded with Bayer to cover-up the scandal and allowed the deadly drug to be distributed globally. No Bayer executives ever faced arrest or prosecution in the United States. http://swine-flu-virus.com/alert-potentially-deadly-swine-flu-spreading-throughout-the-u-s.html

In The U.S. we have two vaccine committees, Vaccines and Related Biological Products Advisory Committee (VRBPAC http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/default.htm) & ACIP ( http://www.cdc.gov/vaccines/recs/ACIP/default.htm): The Advisory Committee on Immunizations Practices.  How many of the people on these committees have ties to the pharmaceutical industry while they pick, choose and approve waivers eliminating liability? 

Since 9-11 our economy has been focused on terrorism risk management, now we turn to pandemic risk management- how convenient for Obama’s health care reforms and pharmaceutical companies profits.  The latest report from the Markle Task Force urges the President and Congress to take swift action to ensure that policy makers have the best information available to confront a stark set of 21st century national security challenges. http://www.markle.org/resources/national_security/

Thanks be to the Gods in White Coats.

Related posts:https://ahrcanum.wordpress.com/2009/05/05/baxter-pharmaceutical-plant-in-mexico-ground-zero-for-flu-outbreak/

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Open wide, say ahhh and check out these posts on the A/H1N1 Swine Flu from Ahrcanum, where the conspiracy spreads as fast as the virus itself .  Our disclaimer-Swine Flu Conspiracy theory can sometimes be triggered by real world events.  https://ahrcanum.wordpress.com/swine-flu-report/

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Now that The World Health Organization has issued a full pandemic threat,  I find my antennae tuning in to the rapid manufacture and issuance of drugs, vaccines and potential for mass inoculations. 

Drug makers have obtained the new influenza A H1N1 seed virus in the past two weeks, enabling them to begin the production process by growing the virus in eggs.  http://www.reuters.com/article/mergersNews/idUSWLA645920090611 

Swiss pharmaceuticals company Novartis AG http://www.novartis.com/  said today, it has produced a first batch of experimental swine flu vaccine.  The vaccine hasn’t yet been tested and cannot be used in humans yet. It was made in cells, rather than grown in eggs as is usually the case with vaccines, the company said. http://www.philstar.com/Article.aspx?articleId=476980&publicationSubCategoryId=200  Damn, that was fast and they didn’t have to use eggs solving a potential problem for those with egg allergens.

Not to be outdone, Sinovac Biotech Company,http://www.sinovac.com/ a vaccine-focused biotech company in China, started efforts to manufacture A/H1N1 influenza vaccine for human use on Monday, after it received the flu strain samples from the WHO, reported Beijing News Tuesday. There are another 10 Chinese drug companies that will obtain the flu strain samples “NYMCX-179A” from the WHO this week. http://english.people.com.cn/90001/90782/90880/6675151.html

It can take five or six months to come up with an entirely novel influenza vaccine,” says John Sterling, Editor in Chief of GEN- Genetic Engineering & Biotechnology News. “There is a great deal of hope that biotech and pharma companies might be able to have something ready sooner.” http://www.genengnews.com/articles/chitem.aspx?aid=2938  In just two weeks he has been proven wrong,  as as scientists around the world are accelerating their efforts to develop a vaccine against the H1N1 influenza virus (Swine flu) as rapidly as possible.  

Chan from WHO said she would recommend that vaccine manufacturers proceed with mass production of an inoculation against the new swine flu strain as soon as they finish production of seasonal vaccine, which she estimated would be complete in about two weeks.  HHS spokesman Bill Hall said Thursday that no decision has been made on full-scale production because there is no need yet to make that decision….. The agency awarded a contract several weeks ago to five manufacturers to develop an H1N1 antigen. The companies are producing pilot lots. Clinical testing will take place over the summer, Hall said.  At the end of the summer, HHS will decide whether to go into production. http://entertainment.wagerweb.com/wtf/who-swine-flu-at-stage-6-and-unstoppable-11967.html 

 Dr. Rambaut says”…the increased detection of mildly deleterious mutations resulting from intensive epidemic surveillance; such mutations would more typically be eliminated and escape detection mutations could be adaptations to the new host species….http://www.nature.com/nature/journal/vnfv/ncurrent/pdf/nature08182.pdf  and at his blog http://tree.bio.ed.ac.uk/groups/influenza/ 

Andrew Rambaut, PhD, of the University of Edinburgh’s Institute of Evolutionary Biology says “These pages exist to enable the rapid dissemination of results resulting from the analysis of genetic data from the ongoing Influenza A/H1N1 outbreak attributed to swine flu. All data used, unless otherwise specified, was made available by GISAID –http://platform.gisaid.org/dante-cms/live/struktur.jdante?aid=1131 or NCBI http://www.ncbi.nlm.nih.gov/  and can be obtained directly from these sites. It is also reviewed at http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/jun1109rambau.html

Citing the world’s best scientists and research- clearly virus mutations can escape detection, have multiple reassortment, have been around for years and contrary to the Pork Industry claims- eight genomic segments of the novel H1N1 have been circulating in swine populations for a number of years, up to 17 years.  How they got there,only God knows- at least so far.

More importantly, how could WHO, the CDC, NATO, IMF, WB, Department of HHS, and any other agency order an H1N1 antigen or a vaccine when the scientists are still studying the viruses genetic make up and its mutations? Drug makers just got a virus seed two weeks ago, yet clinical studies will take place in the U.S. this summer?  What about the criteria for safety, potency and quality?  Will these anticipated clinical testings take place on animals before the initiation of human clinical trials?

Are you willing to stand in line for an untested vaccine against H1N1?  Maybe they will develop an oral one that can be mailed via the post office while you are in isolation or quarantine.

One year ago, a new technology predicted that significant outbreaks of the H1N1 flu virus would occur within 6 to 12 months…Would- not Could!  The predictions, made by Replikins, were based on correlations of flu virus specimen and Pub Med documentation of major outbreaks during the past 90 years.” Naturally Replikins’ officials say the company’s PanFLu™ vaccine is ready for clinical trials.  Other H1N1 vaccine programs covered in the GEN article include those at Medicago, VaxInnate, NanoBio, Vaxart, Pulmatrix, and Purdue University.  Novavax plans to create a virus-like particle-based (VLP) vaccine against the H1N1 strain, which obviates the need for a live virus seed for manufacturing. The VLPs contain the proteins that make the virus’ outer shell and the surface proteins, without the RNA required for replication. props to  http://www.medicalnewstoday.com/articles/152456.php

How could these companies have known?  How much money are they about to make?  How much more money is Obama going seek for a vaccine?  Will the vaccine kill more people than the virus as in the previous Swine Flu scare?

Health Secretary Kathleen Sebelius “things could possibly be very different in the fall, especially if things change in the southern hemisphere, and we need to start preparing now in order to be ready for a possible H1N1 immunization campaign starting in late September,” she said.http://news.xinhuanet.com/english/2009-06/12/content_11528978.htm .

This year’s seasonal flu shot http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/feb1309selection-br.html changed one of the three strains used in flu vaccines, keeping the influenza A/H1N1 and A/H3N2 variants used in this year’s vaccine, both of which are labeled Brisbane strains. The influenza B component of this year’s flu vaccine was from the Yamagata lineage.  This was decided in February prior to the H1N1 outbreak; how sure are they months later that this year’s annual flu shot will not do more harm than good or encourage viral mutations?

http://www.cdc.gov/flu/weekly/”>http://www.cdc.gov/flu/weekly/ has the flu surveillance report.

Over at the Virology blog http://www.virology.ws/2009/06/09/influenza-virus-toilet/ the author spotted the words ‘Kills Flu Virus’ on a bottle of Clorox toilet bowl cleaner. 

Some idiot is going to drink this to prevent the flu; just like they will stand in line to get a flu shot.  

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Open wide, say ahhh and check out these posts on the A/H1N1 Swine Flu from Ahrcanum, where the conspiracy spreads as fast as the virus itself .  Our disclaimer-Swine Flu Conspiracy theory can sometimes be triggered by real world events.  https://ahrcanum.wordpress.com/swine-flu-report/

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