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Posts Tagged ‘Tamiflu’

 tamiflu expired

Un-freaking believable.

I don’t drink milk past its expiration date and I don’t eat rotten food, but something smells fishy at the Food and Drug Administration.

To help combat the H1N1 flu, the U.S. Department of Health and Human Services is releasing 300,000 doses of the children’s antiviral drug liquid Tamiflu to the states that need it. States will begin receiving those doses next week, Schuchat said.  Some of these doses of liquid Tamiflu have an expired expiration date, Schuchat said. “But we want people to know that the U.S. Food and Drug Administration has extended the expiration date of those courses after careful testing,” she explained.http://health.usnews.com/articles/health/healthday/2009/10/01/28-pregnant-women-have-died-from-swine-flu-cdc.html

The FDA claims that the expired lots of Tamiflu for Oral Suspension are part of the Strategic National Stockpile of drugs for use in public health emergencies like the H1N1 Pandemic. The Tamiflu lots in question have been tested through the federal government’s Shelf-Life Extension Program, (SLEP) said the FDA.

What the heck else has expired in the National Stockpile?  Is there any gold in Fort Knox?  Is there any oil in the reserves?

Is the government so desperate that it would release expired medicine into the population? 

There is also inconsistent dosing instructions blamed for confusion on dosing Tamiflu for children. 

“The problem is that the dosing instructions on the Tamiflu labeling does not always coincide with the measurement markings on the plastic syringe included with the drug to deliver the liquid medication, the officials said. For example, Tamiflu Oral Suspension tells users to give children three-fourths of a teaspoon of the medicine twice a day, but the syringe provided is marked in milligrams (not teaspoons), the scientists said. “The authors cite a case that they say is probably happening all over the United States.”

“It’s an egregious error that there is a conflict in the prescription labeling instructions and the dosage device that comes in the exact same box.

 http://www.healthday.com/Article.asp?AID=631327 

 An egregious error?  Undoubtedly, too much Tamiflu can cause side effects too little renders it useless.  While the government has given Swine Flu Vaccine Manufacturers immunity, I doubt Tamiflu is included under that umbrella.  And what have they done about it to correct it?

300,000 expired doses of Tamiflu are being distributed with the wrong dosing instructions!  Parents administer this product, traditionally not doctors. How many milligrams in a teaspoon? 

Where is the due diligence? 

As far back as June 2009, The Straits newspaper reported Singapore’s Ministry of Health has sent expired Tamiflu supplies to the general practitioner’s in Singapore.  Tamiflu, which comes in boxes of 10 pills each, is the anti-viral drug for the H1N1 flu. According to the report and to my own sources as well, these Tamiflu meds have expiry dates of 2007, and was manufactured in 2003. MOH has added a sticker that says that these meds can be used beyond their shelf life – to 2010 http://www.techgoondu.com/2009/06/25/doctors-given-expired-tamiflu-in-singapore/

‘Tamiflu is not without its side effects…so when that happens we won’t know if it’s because the drugs are expired or because of the side effects,’ he said. (from ST)  These pills sat on a shelf in Singapore for SIX YEARS, TWO YEARS after they expired.  WHY keep them unless you think you might need them? 

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm184770.htm

Tamiflu for Oral Suspension

Lot number Manufacturer’s original expiry date Date Supported by SLEP Testing
B1184 June 30, 2009 May 31, 2011
B1185 June 30, 2009 May 31, 2011
B1186 June 30, 2009 May 31, 2011
B1187 June 30, 2009 May 31, 2011
B1042 January 31, 2005 May 31, 2011
B1045 May 31, 2005 February 28, 2010
B1046 November 30, 2005 February 28, 2010
B1047 November 30, 2005 February 28, 2010
B1048 January 31, 2006 August 31, 2010
B1050 January 31, 2006 August 31, 2010
B1051 January 31, 2006 August 31, 2010
B1052 January 31, 2006 August 31, 2010
B1053 January 31, 2006 August 31, 2010
B1054 January 31, 2006 August 31, 2010
B1055 January 31, 2006 August 31, 2010
B1065 June 30, 2006 August 31, 2010
B1082 May 31, 2007 May 31, 2011
B1097 June 30, 2007 May 31, 2011
B1098 June 30, 2007 May 31, 2011
B1188 June 30, 2009 May 31, 2011
B1189 June 30, 2009 May 31, 2011
B120553 August 8, 2009 October 31, 2011
B120650 August 8, 2009 October 31, 2011
B1213 November 1, 2009 October 31, 2011
B1214 November 1, 2009 October 31, 2011
B1216 November 1, 2009 October 31, 2011

In the U.S., these expired lots sat for FOUR years, collecting dust and now the government of U.S. is giving them to children. 

We can not find any site that shows an authenticating testing of these drugs to be safe beyond the expiration date.  Take the government’s word for it.

Got to love that transparency thing!

The package insert for Tamiflu is here at http://www.rocheusa.com/products/Tamiflu/PI.pdf OMG.   

Brands are ® by repective owners.
 

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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.

Swine Flu Conspiracy can sometimes be triggered by real world events.  Subscribe NOW in the top right margin for further updates.

https://ahrcanum.wordpress.com/swine-flu-report/

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In searching out how A/H1N1 has come to exist or mutate into existence, my antenna are turning toward Gilead Sciences Inc., the makers Tamiflu.

  • Gilead Science 50% of the Gilead Sciences Inc. stock is owned by  Donald Rumsfeld, Tony Blair, Cindy McCain,  FBI Division 5 William Morris Agency, Tom Brokaw.  Brokaw has replaced the late Tim Russert as host of NBC’s alleged interview show “Meet the Press”.  Retired Republican Senator William Frist of Tennessee has major investments in the bird flu vaccine, virus. http://www.newsfollowup.com/veterans_anthrax.htm 
  • Two French biochemical students, Laurent Bonomo and Gabriel Ferez, joined the list of dead scientists when they were murdered by Israeli Mossad-British intelligence assassination teams on June 29, 2008. Both Bonomo and Ferez were studying at the prestigious London Imperial College researching the origins of bird flu and the link to the alleged vaccines….The two researchers had discovered that the alleged bird flu vaccine, H-7, which was designed to neutralize and stop the H5N1 avian flu virus, had been spliced using DNA to actually create a vaccine and an illness producing virus at the same time. The French students had also discovered that the bird flu vaccine, i.e. a virus, had links to U.S., British and Israeli laboratories associated with the noted Mossad agent, Dr. Philip M. Zackerie.  http://www.americanfreepress.net/html/bio-chemists_murdered_149.html

    Israeli microbiologist, Dr. Zackerie known as “Dr. Zack,” worked for the U.S. bio-weapons lab at Ft. Detrick, Md. where I wonder by some coincidence is where the last Swine Flu Outbreak Occurred.  He was a consultant at the FBI linked company Gilead Sciences Inc. of Boulder, Colo. Gilead Sciences has been linked to the 9-11 anthrax strain and to the bird flu vaccine.

    Blogger Tom Heneghan asserts at http://blogs.myspace.com/index.cfm?fuseaction=blog.view&friendId=147509065&blogId=486979763 “that U.S. Army investigators are looking into the actual theft of disease samples tied to the Swine Flu virus that are missing from the bio lab at Ft. Detrick, Maryland.

    This is the same bio lab where researchers study deadly pathogens, including Ebola, Anthrax and Plague and that the operational team unleashing the Swine Flu was a joint U.S.-Israeli Mossad group that transported the Swine Flu in vials from Fort Detrick, Maryland to Fort Dix, New Jersey and on to Mexico City.

    He goes on to note that White House Chief of Staff and former head of the North American Israeli Mossad, Rahm Emanuel, has direct control over the U.S. Treasury, working hand in hand with current U.S. Treasury Secretary Timothy Geithner.

    Coincidentally or Ironically depending on how you look at it the Army did announce last week that, “An inventory of potentially deadly pathogens at Fort Detrick’s infectious disease laboratory found more than 9,000 vials that had not been accounted for.” https://ahrcanum.wordpress.com/2009/06/24/ft-detrick-lab-missing-9000-virus-vials-scientists-still-dying-from-unnatural-causes/

    It is not as if the U.S. and other countries have not been remiss in planning for an influenza pandemic.  There are government stockpiles of small pox vaccines and antiviral drugs from Roche AG and Gilead Sciences Tamiflu, and Glaxo Smith Kine, Niota’s Relenza and who knows what else.  Scientists are working feverishly with numerous announcements that a vaccine will be ready soon.  Novartis announced recently that it has developed the first vaccine batch against A/H1N1.  Obama and HHS have ordered millions worth of vaccine ingredients from its five corporate suppliers and if I recall, nearly one billion in stimulus money targeted toward the flu. 

    Numerous sources are reporting that while A/H1N1 and H3N2 virus are jumping borders it looks like the seasonal H1N1 has mutated into a form that resists Tamiflu, although it is still susceptible to Relenza supposedly.  sourced from   http://www.iii.co.uk/news/?type=afxnews&articleid=7368116&subject=economic&action=article

    “Investors are in a bit of a conundrum. There’s potential for the companies to make some extra revenue, but investors are going to have to hope that the swine flu pandemic gets worse from The Motley Fool http://www.fool.com/investing/international/2009/06/12/be-careful-what-you-wish-for.aspx who outlines the major pharma companies most likely to benefit.

    As it turns out, “Scientists have established the first case of the new H1N1 influenza strain showing resistance to Tamiflu, the main antiviral flu drug,” according to Reuters –http://www.reuters.com/article/healthNews/idUSTRE55S3UM20090629

    “It is well known and expected that influenza virus can mutate spontaneously. The resistance has not changed the capability of the virus to transmit or cause disease, and the assessment is still that this is a relatively mild influenza,”said David Daigle, a spokesman for the U.S. Centers for Disease Control and Prevention.

    This relatively described mild influenza has killed 231 and infected 52,000+ as reported by the CDC, http://www.who.int/csr/don/2009_06_22/en/index.html but that is only the reported cases.

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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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     tamiflu

    What a bunch of double speak from not only our elected officials but, governments around the world.  I know they just don’t know, but I also think they know that we know, that they know, that we know that something is amiss. 

    Nearly a month ago, Mexico 1st became aware that there was a problem and was as slow as molasses to take steps to warn people of a possible health threat- similar to the Chinese who at least admitted they were negligent with SARS reporting delays in efforts to control the epidemic. http://en.wikipedia.org/wiki/Severe_acute_respiratory_syndrome

    While not eliminated, the last infected human case of SARS was in June 2003.  There is no rapid response testing for SARS.  In 2003, WHO announced that “a new pathogen, a member of the coronavirus family never before seen in humans, is the cause of Severe Acute Respiratory Syndrome (SARS)” http://www.who.int/mediacentre/news/releases/2003/pr31/en/ Here we are six years later, and we have another new pathogen never seen before that is a mutation of pig, bird, human.  Both virus’ are spread by simple human to human contact. 

    Canada is now reporting infected pigs. Peter Ben Embarek, a WHO food safety scientist said, “The virus that infected the pigs is the same one that is in circulation among people, and there is no indication that the transfer between species has caused the flu bug to mutate into a new or dangerous form,” Embarek said and continues to reiterate that eating pork is safe. “You can continue to safely eat your prosciutto.” http://www.usatoday.com/news/health/2009-05-03-canada-flu_N.htm I wouldn’t eat a cow with mad cow disease, a chicken with avian flu, or have sex with someone who has AIDS, why would I eat the contaminated pig?

    “With AIDS you have to get fu*^ed in someway; either by a contaminated parter during sex, the medical system, blood transfusions, etc., not just getting coughed on by a ill person.  There is no cure for AIDS either, and the last confirmed report of someone having AIDS was probably yesterday.  Science hasn’t cured the common cold, let alone AIDS, SARS, or the Swine Flu.

    “During this outbreak of a novel H1N1 flu virus (formerly referred to as “swine flu”), there will be increased demand in the U.S. for a variety of medical products that may help treat or prevent influenza, including antiviral drugs and personal protection equipment, such as masks. Consumers may seek to purchase such products, including, with a prescription, antiviral drugs. Depending on how this virus spreads and the current situation evolves, consumers and patients may encounter some shortages of these products, as the demand may occasionally exceed the supply available directly to consumers in some locations, creating what are often called, “spot shortages.”  {emphasis mine} http://sharing.govdelivery.com/bulletins/GD/USHHS-735DB

    Just days ago, the CDC said they have enough anti-viral drugs to combat a spreading outbreak of swine flu.  ”  Acting CDC director Richard Besser said, “ There are no reports, and we don’t expect any reports, of shortages of any anti-virals in any states,” he told reporters.  {empasis mine} The CDC’s interim director for public health, Anne Schuchat, said the US government has “extensive supplies” of the drugs oseltamir (Tamiflu) and zanamivir (Relenza). http://www.google.com/hostednews/afp/article/ALeqM5gsCu6xmwGDfldVN8sTUQzfBauuOQ

    Maybe CDC and DHS might want to start communicating a little better as one agency says we have enough and the other that drugs will be in short supply?   

    The government bulletin goes on to say that, “The federal government is purchasing additional supplies of these products to refresh the Strategic National Stockpile so that it can continue to meet our public health needs.”  This translates into the fact that there will be less Antivirals on the shelf at the local pharmacy.   A quick survey of several pharmacy’s in and around the City of Snohomish near Seattle, Washington finds that they are all out of the treasured TamiFLU anti-viral medicine. http://www.snohomishtimes.com/snohomishNEWS.cfm?inc=story&newsID=507  “Pharmaceutical giant Roche stopped delivering the flu remedy Tamiflu to French high street pharmacies on Thursday, after panic over the swine flu outbreak saw it disappearing off the shelves.  http://www.google.com/hostednews/afp/article/ALeqM5j0g8mOFeQael0wAaEyLDCagwtnGwMedicines to fight the virus, such as Tamiflu and Relenza, must be taken within 48 hours of first symptoms to do any good.

    Don’t you feel better knowing than the government will be in charge and have ownership of our banking system, automobile manufacturing, the unions, and now potentially the medicine that could save lives? 

    While the drugs are far from a cure, they seems to have some treatment properties for the standard flu and apparently in some cases, Swine Flu.  Testing for Swine flu and like SARS is far from reliable.  “The rRT-PCR Swine Flu Panel diagnostic test has not been approved or cleared by the FDA. “(empasis mine) An EUA allows this unapproved diagnostic kit to be legally distributed and used for the authorized purposes. Section 8 from cdc http://www.cdc.gov/h1n1flu/eua/qa.htm.  “The CDC says ”A negative RT-PCR test should not be interpreted as demonstrating that the patient does not have swine influenza virus infection.”  http://www.swinefluprevent.org/interpreting-swine-influenca-rt-pcr-detection-panel-test-results-fact-sheet-for-healthcare-providers  Even the tests for SARS are far from reliable with some taking up to 21 days to diagnose and again that the results are not definitive. {Wiki}.

     “I have no higher priority as President of the United States than the safety and security of the American people, and I will do whatever is necessary to protect this country. ” said President Obama in his weekly White House address.  http://www.whitehouse.gov/the_press_office/WEEKLY-ADDRESS-President-Obama-Outlines-Government-Actions-to-Address-the-2009-H1N1-Flu/  In contrast to his priority of keeping antivirals available for Americans, last week President Obama authorized  Health and Human Services Secretary Kathleen Sebelius to send 400,000 Treatment Courses Deployed to Mexico last Thursday. http://www.hhs.gov/news/press/2009pres/04/20090430a.html 

    The World Health Organization said Saturday it has sent 2.4 million treatments of anti-flu drug Tamiflu to 72 developing countries preparing themselves against a possible swine flu pandemic.  The drugs came from a WHO stockpile donated by drug maker Roche Holding AG, Dr. Mike Ryan, WHO’s global alert and response director, told a news conference in Geneva. http://www.etaiwannews.com/etn/news_content.php?id=937607&lang=eng_news&cate_img=316.jpg&cate_rss=news_Health 

    It isn’t even flu season yet.  Will this early response and release of antivirals and effect on the current outbreak jeopardize the efforts to prevent the standard flu witch kills more than a half a million people worldwide every ear?  4 May 2009 — As of 06:00 GMT, 4 May 2009, 20 countries have officially reported 985 cases of influenza A (H1N1) infection. http://www.who.int/csr/don/2009_05_04/en/index.html  How many cases will develop and how far this spreads is anyone’s guess.  

    Not to be outdone in profiteering from the flu or pandemics. ” The world’s second-richest man( Warren Buffett) also said Berkshire, which generates about half its business from insurance, would consider writing policies to insure against a potential swine flu pandemic if it got paid enough. http://www.reuters.com/article/newsOne/idUSTRE5422NI20090504 

    You might like these related posts-

    The most reliable Google Maps on Swine Flu is being put assembled by Henry Niman, founder Recombinomics, who has been tracing the evolution of influenza for the last five years  http://maps.google.com/maps/ms?ie=UTF8&hl=en&t=p&msa=0&msid=106484775090296685271.0004681a37b713f6b5950&ll=47.517201,-109.335937&spn=101.871352,255.585938&z=2 

    Related—

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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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     swine-influenza_virus_particle_color

     

    On April 26, 2009, pursuant to section 564(b)(1)(C) of the Act (21 U.S.C. § 360bbb-3(b)(1)(C)), the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency under 42 U.S.C. § 247d that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such an agent or agents — in this case, swine influenza A (H1N1).

    Joshua M. Sharfstein, MD, Principal Deputy Commissioner, Acting Commissioner for the FDA  wrote he is “authorizing the emergency use of the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) for the presumptive diagnosis of swine influenza A (H1N1) virus infection in human individuals who have been diagnosed with influenza, caused by a virus not subtypeable by currently available FDA-cleared devices, (emphasis mine) subject to the terms of this authorization.”http://www.fda.gov/cdrh/emergency/panel-authorization.html#ft1 

    An Emergency Use Authorization (EUA) was issued by the Food and Drug Administration (FDA) to allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents. 

    ”The US Centre for Disease Control and Prevention (CDC) sent materials for a quick diagnostic test to Mexico so scientists there can quickly screen people for the new flu.  The centre’s Dr Richard Besser said test kits were also en route to health departments in all US states to speed up surveillance.” http://www.prisonplanet.com/mexico-encouraged-by-fall-in-new-flu-cases.htmlWhatever  Funny thing is, ” Currently, the EUAs do not include translated versions of fact sheets.” 

    So what’s the problem?  The tests have not been approved, are unreliable and physicians around the world may not be able to read English! 

    Section 8- “While Tamiflu and Relenza have been previously approved by the FDA, certain aspects of the distribution and use of these products are not covered by their approved applications.  An EUA allows these drugs to be legally distributed for the unapproved (empasis mine) uses for which they are being authorized.  FDA has authorized emergency use of disposable N95 respirators by the general public during this declared emergency.  These respirators may help to keep out germs that may be present in the air you breathe.  The rRT-PCR Swine Flu Panel diagnostic test has not been approved or cleared by the FDA. “(empasis mine) An EUA allows this unapproved diagnostic kit to be legally distributed and used for the authorized purposes.

    Disposable N95 respirators offered by Survivair say ” The ONE-Fit NBW95 and NBW95V meet NIOSH N95 standards, CDC guidelines for M Tuberculosis exposure control and are recommended as sufficient protection against many substances, including pandemic diseases such as H5N1 Avian Flu and SARS. air-mask-apr_valueairhttp://www.survivair.com/search/searchResults.asp This mask is a far cry from the paper thin masks I see people wearing.  Other sources for masks are here- http://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/n95list1.htmlA EUA is currently in effect. ” The FDA made available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances.  On April 27, 2009, the FDA issued EUAs for the use of certain antiviral products (Relenza, Tamiflu), N95 respirators, and for the rRT-PCR Swine Flu Panel diagnostic test. Additional information on these EUAs can also be found on FDA 2009 H1N1 Virus site http://www.cdc.gov/h1n1flu/eua/qa.htm 

    Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act), amended by the Project BioShield Act of 2004, permits authorization of such products for use in diagnosing, treating, or preventing serious or life-threatening diseases or conditions caused by biological, chemical, radiological, or nuclear agents even when they are not approved AND ,

    Even though WHO has renamed the Swine Flu to A/H1N1   or  Influenza H1N1, an FDA, CDC report says, “Swine flu is a respiratory disease of pigs caused by type A influenza virus that regularly causes outbreaks of influenza in pigs . Human cases of swine flu virus infection have been identified in the United States and internationally. CDC has determined that this virus is contagious and is spreading from human to human. ” http://www.fda.gov/cdrh/emergency/panel-factsheet2.html

    Despite “the fact that it (the test) does not meet certain requirements otherwise required by federal law” it is being distributed to public health and other qualified laboratories and doing so with no liability on the part of the government.  Sharfstein also waived any liability for citizens should the test or cure result in additional illness, death or damages. “The Public Readiness and Emergency Preparedness Act (“PREP Act”) enacted as Division C of the Defense Appropriations Act for fiscal year 2006, Pub. L. No. 109-148, added new authorities under the Public Health Service (PHS) Act to alleviate concerns about liability related to the manufacture, testing, development, distribution, administration and use of countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/medication-vaccine-qa.html

    Let’s hope The rRT-PCR Swine Flu Panel speeds up identifying cases.  The vaccine for the original swine flu ended up killing more people than the virus itself.

    I would expect numbers to rise due localized testing rather than having to send samples direct to the CDC.  I find it interesting as well that the CDC says “A negative RT-PCR test should not be interpreted as demonstrating that the patient does not have swine influenza virus infection.”  http://www.swinefluprevent.org/interpreting-swine-influenca-rt-pcr-detection-panel-test-results-fact-sheet-for-healthcare-providers

    To summarize The rRT-PCR Swine Flu Panel:

    1.  The test was never approved for this use.

    2.  The test results are unreliable.

    3.  There is no liability.

    4.  Our tax dollars are paying for this for U.S. and world wide distribution.

    5.  The Instructions are in English.

    6.  It might save lives just to spite itself.

     You might like these related posts-

    The most reliable Google Maps on Swine Flu is being put assembled by Henry Niman, founder Recombinomics, who has been tracing the evolution of influenza for the last five years  http://maps.google.com/maps/ms?ie=UTF8&hl=en&t=p&msa=0&msid=106484775090296685271.0004681a37b713f6b5950&ll=47.517201,-109.335937&spn=101.871352,255.585938&z=2 

    flag tounge

    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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