Are GlaxoSmithKline and the FDA lying to parents about the Rotarix Recall?

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Are GlaxoSmithKline and the FDA lying to parents about the Rotarix Recall?

March 25, 2010 by Lynn Swearingen

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Suppose your child could become seriously ill and Rotavirus could be bypassed with the use of a vaccine. Your Pediatrician’s recommendation? Rotarix, which is developed and marketed by GlaxoSmithKline.

Well, Rotarix won’t be the recommendation any longer because the FDA has discovered that – oops – this vaccine that was given to over 30 million children worldwide since 2008 contained a contaminating virus known as PCV-1. Rotarix use has been “temporarily suspended”.

“The contaminating virus in Rotarix is called porcine circovirus type 1 or PCV-1. This is not known to cause disease.”

The recent recall and FDA statement of safety seems to be quite clear:

“PCV-1 does not multiply in humans and is not known to cause illness in humans. It is found in everyday meat products and is frequently eaten with no resulting disease or illness,” the company said in a statement on Monday

“This was a difficult decision for us because there is no evidence at this time that there is a risk to children,” said Dr. Margaret Hamburg, the Food and Drug Administration commissioner. “

Really? According to a PubMed.gov 2004 study, which just happens to be the NIH (U.S. National Library of Medicine National Institutes of Health),

“Infection of PCV1 was observed with 293, Hela and Chang liver cells, infection with PCV2 only in Rd cells. In addition, religated viral DNA of PCV1 and PCV2 has been used to transfect adherent human cell lines.”

The World Health Organization began recommending in 2009 that all Nations include this vaccination in their immunization program. Based on research during a clinical trial in which GlaxoSmithKline suprisingly enough participated in the funding.

So just so we understand this:

NIH completes a study in 2004 showing clear crossover from Porcine to Human cell lines (2004)
GlaxoSmithKline develops Rotarix (2005)
GlaxoSmithKline funded the clinical trials (2006)
GlaxoSmithKline sells Rotarix (2008 forward)
GlaxoSmithKline gets caught with a contaminated product (2010)

FDA/GlaxoSmithKline soothes parents with double-speak (2010)

The stated data indicates that over 500,000 children die each year from the effects of Rotavirus. The other 31 million? Well one could just wait and see what data is true. The FDA, GSK or the NIH? Or I suppose one could contact the Consumer Affairs Branch of the FDA and request clarification/investigation into the recall of Rotarix. One might also request exactly why the NIH says PCV-1 can be transferred to humans when the FDA is denying such can occur.

Consumer Affairs Branch (CBER)

ocod@fda.hhs.gov

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448

Posted in Biometrics, Child endangerment, eugenics, HEALTH, NHIS, Uncategorized, vaccines | Tagged contamination, FDA, GSK, vaccines, WHO | 18 Comments

18 Responses

on June 7, 2011 at 08:47 The Emergence of Vaccine Induced Diseases « Anti Oligarch

[...] Rotarix vaccine, a GlaxoSmithKline vaccine for use on children and documented here [...]
on May 31, 2011 at 18:20 The emergence of Vaccine induced Diseases « Believe nothing

[...] The Rotarix vaccine, a GlaxoSmithKline vaccine for use on children anddocumented here : [...]
on April 22, 2011 at 06:06 The emergence of Vaccine induced Diseases « nextlevelnutritiondotcom

[...] The Rotarix vaccine, a GlaxoSmithKline vaccine for use on children and documented here : [...]
on April 20, 2011 at 12:52 The Emergence of Vaccine Induced Diseases | .....Aaron's EnvironMental Corner.....

[...] Rotarix vaccine, a GlaxoSmithKline vaccine for use on children and documented here : According to a PubMed.gov 2004 study, which just happens to be the NIH (U.S. National Library of [...]
on April 14, 2011 at 18:01 The Emergence of Vaccine Induced Diseases

[...] Rotarix vaccine, a GlaxoSmithKline vaccine for use on children andÂ documented here [...]
on April 14, 2011 at 10:46 On Vaccines « Gordonshumwaydays's Blog

[...] Rotarix vaccine, a GlaxoSmithKline vaccine for use on children anddocumented here [...]
on April 13, 2011 at 17:17 The Emergence of Vaccine Induced Diseases « Serpents & Doves

[...] Rotarix vaccine, a GlaxoSmithKline vaccine for use on children and documented here : According to a PubMed.gov 2004 study, which just happens to be the NIH (U.S. National Library of [...]
on April 12, 2011 at 21:37 The Emergence of Vaccine Induced Diseases

[...] Rotarix vaccine, a GlaxoSmithKline vaccine for use on children and documented here : According to a PubMed.gov 2004 study, which just happens to be the NIH (U.S. National Library of [...]
on April 12, 2011 at 21:17 The Emergence of Vaccine Induced Diseases | Independent News Hub

[...] Rotarix vaccine, a GlaxoSmithKline vaccine for use on children and documented here [...]
on April 12, 2011 at 15:05 The Emergence of Vaccine Induced Diseases / We know and will tell you all what really happened today

[...] Rotarix vaccine, a GlaxoSmithKline vaccine for use on children and documented here : According to a PubMed.gov 2004 study, which just happens to be the NIH (U.S. National [...]
on April 12, 2011 at 05:31 The Emergence of Vaccine Induced Diseases | Sovereign Independent

[...] The Rotarix vaccine, a GlaxoSmithKline vaccine for use on children and documented here : [...]
on April 8, 2011 at 02:25 The emergence of Vaccine induced Diseases « The PPJ Gazette

[...] The Rotarix vaccine, a GlaxoSmithKline vaccine for use on children and documented here : [...]
on March 8, 2011 at 01:02 Vaccine and Medication Lottery « The PPJ Gazette

[...] have been wide-ranging batch recalls : Rotarix, H1N1, Measles, Rabies (animal lovers worry as well), Flu in ’07, Gardasil in ’09, [...]
on February 23, 2011 at 03:01 Meegan Allen

My own daughter recieved this recommended vaccine in NSW in 2009 at the recommended 14 weeks. I nearly lost her life 4 times. She now has a diagnosed permanent bowel damage. There is no support or treatment available despite me taking her to GP’s, pediatricians and bowel specialists. They simply do not know how to fix the injury. I have been offered “experimental” bowel surgery for her. I want a campaign that informs mothers that immunisation is not compulsary, that their children can still go to school and daycare. I also want the Governemment to get rid of this dangerous vaccine from their recommended “Schedule” which is continuously pushed on tired and uninformed mothers by every health nurse and Doctor from the day the child is born. Meegan Allen (0458250310). I have also read anecdotes of other Australian mothers who’s children have had similar “unexplained” bowel conditions following this vaccine. In September 2010 GlaxoSmithKline (the drug company) put a new warning on the vaccine that it is known to increase the risk of fatal bowel disease and bowel abnormalities (such as the documented intersusseption).
on October 9, 2010 at 20:27 Lettuce: If eating it might kill you, would you still buy it? « The PPJ Gazette

[...] Rotarix Recall [...]
on June 1, 2010 at 21:03 Kids swallow DNA of lethal pig viruses in vaccines « The PPJ Gazette

[...] 1, 2010 by ppjg In March of 2010, one of our authors, Lynn Swearingen, posted this article about the Rotarix recall. Are GlaxoSmithKline and the FDA lying to parents about the [...]
on May 7, 2010 at 22:35 ppjg

Well isn’t this just dandy. And the penalty for this was what? Let me guess……nothing. Marti
on May 7, 2010 at 15:08 Lynn Swearingen

UPDATE: Wall Street Journal

http://online.wsj.com/article/BT-CO-20100506-717704.html?mod=WSJ_latestheadlines

“The Food and Drug Administration said Thursday fragments of two types of pig viruses were found in Merck & Co.’s (MRK) Rotateq vaccine.

One virus is the same one found in GlaxoSmithKline PLC’s (GSK) Rotarix vaccine in March. At the time, the FDA recommended doctors stop using that vaccine and use Rotateq. ”

Oops they did it again.

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