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SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil To ..

Discussion in 'Merck' started by Anonymous, Sep 7, 2011 at 6:12 PM.

  1. Anonymous

    Anonymous Guest

    SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil To FDA: Requests Public Safety Investigation

    TROY, Mont.--(BUSINESS WIRE)--Sep 6, 2011 - SANE Vax Inc. announced today they sent a certified letter to FDA Commissioner, Dr. Margaret Hamburg, to inform the agency 100% of 13 samples of Merck & Companies HPV 4 Quadrivalent vaccine, Gardasil™ have been found to be contaminated with recombinant HPV DNA. The vaccine vials were from different lots currently marketed in the United States, Australia, New Zealand, Spain, France and Poland.

    Medical consumers from these countries asked SANE Vax Inc. to help determine if there is residual recombinant HPV DNA in the Gardasil™ vaccine currently used by their doctors. They are concerned that the recombinant DNA, if present, may have triggered some of the autoimmune-based inflammatory disorders and malignant tumors observed among children/young women after receiving Gardasil™ vaccinations.

    According to Norma Erickson, president of SANE Vax, “A sexually naïve girl developed acute juvenile rheumatoid arthritis at age 13 within 24 hours after the third Gardasil™ injection and her blood sample - tested two years later - was found to be positive for HPV DNA by a local clinical laboratory.” A possible connection between HPV DNA in Gardasil™ and leukemia or lymphoma has also been raised by vaccine safety advocates, said Erickson.

    The letter sent to Dr. Margaret Hamburg at the FDA stated, “One of the HPV DNA fragments detected in the vaccine is part of a synthetic construct (GenBank Locus SCU55993) for HPV11 major capsid protein L1 gene, a recombinant DNA genetically engineered specifically for manufacturing of the Gardasil vaccine.”

    “There is no doubt that the HPV DNA found in the vaccine represents an adventitious agent left over from the DNA recombinant manufacturing process with potential adverse impacts on health safety of those vaccinated. The recombinant DNA found in Gardasil is very tightly bound to aluminum hydroxyphosphate. When injected intramuscularly, this combination may function as a DNA vaccine with uncertain consequences,” said Erickson.

    Both the FDA and the vaccine manufacturer assumed that there was no HPV DNA in Gardasil™ when the vaccine was approved for marketing, according to SANE Vax.

    “Because one hundred percent of the samples tested were positive for HPV DNA contamination, SANE Vax Inc. requests the FDA investigate the extent of the HPV DNA contamination in the Gardasil HPV4 vaccine currently on the market and take appropriate actions to ensure public safety regarding future shipments,” stated the letter.

    The HPV DNA testing was performed by Dr. Sin Hang Lee, a pathologist at the Milford Hospital pathology laboratory known in using cutting-edge DNA sequencing for molecular diagnoses. This methodology was first reported to the FDA in 2006 and has been published in various peer-reviewed scientific journals, stated Erickson.



    Contact: SANE Vax, Inc.
    Norma Erickson, 406-295-5218
    admin@sanevax.org

    http://sanevax.org/sane-vax-inc-rep...-to-fda-requests-public-safety-investigation/
     
  2. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    Merck has become a 3rd world pharmaceutical company.
     
  3. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    Seriously, fire everyone in manufacturing, they've been bringing this company down for half a decade now. You'd think Dick Clark coming from manufacturing to be CEO before would mean that division would be rock solid, but it's the opposite. Now, we have legal running everything and destroying innovation and business.
     
  4. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    And Merck will handle this just like they handled Vioxx...deny, deny, deny until the FDA is forced to do something. It's one thing when adults are hurt, when kids get hurt, look out. Merck will finally get what it desrerves.
     
  5. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    Oh shit, here we go again.
     
  6. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    Great, as if trying to sell a vaccine with this many reactions isn't hard enough already...
     
  7. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    Go to Sane Vax website and search for anyone with credible credentials. They're going after Cervarix, too.
     
  8. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    Let's face it, Merck has never been honest when it comes to this vaccine.
     
  9. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    Besides that, Merck does not know what the hell is going on with production.
     
  10. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    With all the manufacturing issues......why does Willie Deese still have a position in this company. He should have been sh**canned years ago.
     
  11. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    It's beyond manufacturing, QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA, QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA,QA needs to be replaced from top to bottom. Try selling our products with this information. They are destroying Merck.
     
  12. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    Dick is a joke- under his watch vaccine manufacturing became as big a joke as this company has become. At one time almost half of the vaccines were not being manufactured and we lost market share that was hard to gain back.
     
  13. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    First charred saran wrap, now this...I gotta get another job
     
  14. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    Been at Merck for a long time now. Pipelines comes and go. This is not the first time we have no had a blockbuster drug coming out. I do understand that the manufacturing process can have issues. Those issues need to be picked up and addressed before it makes it's way out the door. Once it's out the door and to the public there is no turning back. You can't un-ring a bell. It does not damage Gardasil but all the drugs we make. This has to stop because it's getting to the point where we will have 0.0 trust by our customers. The manufacturing process is the easy part of the chain. We should not have issues like this. Maybe we are not staffing the department with the right people.
     
  15. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    when do we understand that something is wrong and needs to be fixed?
     
  16. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    I remember when we were at the launch meeting and they were laying out the marketing
    strategy for Gardasil...You didn't have to be a genius to see that the whole thing stank,
    from day one...

    Unless my daughter was a porn star, I would not let her near this vaccine...just get your annual PAP and stay away from crooked Merck and their "breakthrough" products.
     
  17. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    All the pharma's bend the truth a little. It goes with the business. The issue is that we can't screw up the product during the manufactoring process. We need a better system in place to pick this shit up. I am sure we have a department that checks this crap. They are sleeping behind the wheel. Not only does it screw with my sales, it fucks up getting products through the pipeline because the FDA has no faith in us. The new products is how we make our money.
     
  18. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    The same thing happened to Schering a few years back. Probably why Clarinex took so long to come to market- the FDA does not like to reward slackers and they were definitely not up to it for manufacturing. Hey- Merck manufactures products with foreign particles lately too- maybe the Schering folks took over here!
     
  19. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    One of the issues is there is little male leadership. QA is dominated by females who just don't get it. The leadership is non existent and needs to be changed. They cost the company big $$$$, to stupid and are out of their league. If this keeps up the 500 million dollar fine 10 years ago will be small.
     
  20. Anonymous

    Anonymous Guest

    Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T

    so your writing that they are a bunch of dumb c*nts. I have a hard time disagreeing with that because of all the moronic things the group as done over the years.
     

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