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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.

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  1. Anonymous

    Anonymous Guest

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

    If you want to fudge the numbers on taxes, sales and marketing by all means do it. Don’t destroy a child’s life. It’s not like cheating on a test during college. If QA can sit by while this is going on they should not be there. If you’re a manager and you don’t have the courage to lead people and speak your mind on issues, maybe you’re not the right person for the job. Maybe they hired people who don’t understand the ramification of what they do. I love Merck but maybe I am things that new merck is old merck. I would love to know how the QA people sleep at night after hearing about this news? If well, they are nothing more that garbage whose life’s are so empty and void of meaning that they will never find happiness no matter what they do in life. They have the morals of a filthy pig.
     
  2. Anonymous

    Anonymous Guest

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

    This is making me crazy!! As a former Merck rep that has followed this vaccine since launch, I am continually agitated of the strong arm and big $$$ incentive/persuasion politically has kept the consumer and healthcare provider uninformed of the risk/benefit quotient. Shame on the politicians in states that have mandated this vaccine for school age girls.... another of the "herd" vaccines.

    When I took my two daughters for their vaccine updates two weeks ago, I listened to the pedatrician's "recommended" presentation for the HPV vaccine. And asked a few questions to see how knowledgeable." How many women died last year from Cervical Cancer?" Her answer was "24". lol..24 plus maybe 3 more zeros would be a little more accurate. "So, Doctor, you want every 11 year old girl to get a vaccine with all the risks/side effects(possible life threatening/limited in vivo study data/unknown age to booster) to prevent 24 cervical cancer deaths? Of which cervical cancer deaths are generally in older women and my daughter would have many years before in that risk category?". I would like to tell these pediatricians I would regard their wisdom as intelligent and highly educated health professionals sans the robotic verbage from the pharma. Interestingly, not one comment on the risks/benefits or "fair balance" as we call it. As an informed consumer, I am challenged in even trusting these physicians with my and my children's health. But I point the finger at our government, big pharma and the mighty $$$$.


    The daughter of a woman I work with is suffering from serious disorders that came on after her Gardisil vaccine. They have contacted Merck and all sorts of govt. agencies to report and seeking help. Of course, denial it is related.

    We are only the little people. But, please be an informed consumer in your choice to the benefit of your child getting this vaccine. Read, read, read and do not depend on anyone else looking after your/your children's health and welfare.
     
  3. Anonymous

    Anonymous Guest

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

    It is called blood money. Not only is it a bad drug that was pushed for political reasons, QA cannot pickup extremely harmful issues. I wonder if the people in QA are confident enough to get their children the injections? I think not because that blood money is too close to home.
     
  4. Anonymous

    Anonymous Guest

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

    If the upper management is looking for something on the side I will give them 1000$ to go get a prostitute. This way they can hire good managers and people for QA rather than whoring them out through Merck. Merck has become a brothel now and it’s destroying children. I miss old Merck. It's a good investment because it will save people.
     
  5. Anonymous

    Anonymous Guest

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

    I can tell you 5 years ago the story of the day was how many affairs the married woman there had with other men (merck and non merck). I don't know how it is now. Something tell me it has not changed.
     
  6. Anonymous

    Anonymous Guest

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

    How do you think the kenilworth inn stays in business? That place is a dump.
     
  7. Anonymous

    Anonymous Guest

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

    how do you think the kenilworth inn stays in business. Thanks to QA
     
  8. Anonymous

    Anonymous Guest

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

    It does explain a lot as far as the QA department but they were not the only ones. They may have had the most activity but there were also a lot of other people. I felt bad because I knew some of the spouses.
     
  9. Anonymous

    Anonymous Guest

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

    1. Previous post: It's not news. It has been that way for the last 10 years. It does explain how the QA managers received their jobs. It is funny how they try to hide the obvious but it none of my business
    2. Gardasil is actually a safe product. There have been very few documented major issues with it. There are side effects but all drug have them. It has been through many regulatory agencies and even with the bad press, no one is moving to take it off the market.
    3. The Gardasil that has DNA Contamination is a issue. It can have very adverse effect on children. What is most disturbing is the 13 samples came from different lots. It will not have a good outcome but I hope it is not extremely bad. Time will tell.

    The manufacturing and QA department really needs a overhaul. I am not to judge moral characters but when something like this happens it does make you wonder. There is no way QA did not pick this up. They just ignored it and hoped it would not bubble up. They were wrong and something needs to be done.

    William Deese should have been let go 3 months after he was hired. He does not bring anything to the table and has made things worse. At best he should only be purchasing ingredients and that is a stretch.

    QA needs some help. I don't thing the proper leaders are in management positions. It's a tough job and you need a certain type of personality to run it. It's one of the few departments that can cause major damage. It is clear there is no check and balances or they are being ignored. I am not in sales but I do feel bad for them. They now need to focus their energy on damage control rather than selling and pitching information to customers.

    What is sad is that this could have been avoided if the proper people were in place.
     
  10. Anonymous

    Anonymous Guest

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

    So the issue is how long has this DNA Contamination been out on the market? Maybe it just started and they tested 13 lots and just got lucky. The rest could be OK and therfor no issues?
     
  11. Anonymous

    Anonymous Guest

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

    You've worked here how long? And you haven't wondered even just once if perhaps you no longer fitted the current Merck ethical culture?
     
  12. Anonymous

    Anonymous Guest

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

    If there is HPV DNA in 100% of 13-14 separate lots of Gardasil, it is there because the process cannot remove it. So it probably is being made perfectly - perfectly badly that is. So it also means that this DNA was always there and it was there when the process was filed with the regulators. Talk to those Merck geniuses responsible for filing this product about how they missed this contaminant. It seems that those repsonsible in R&D and registration (and by extension upper management) are applying the same standards that made Vioxx such a big success (for the legal profession).
     
  13. Anonymous

    Anonymous Guest

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

    I like the filthy pig comment. That is the ultimate description of the QA department at Merck. Maybe they need the Gardasil injections. They could go total retard and no one would notice the difference.
     
  14. Anonymous

    Anonymous Guest

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

    Gardasil Patient Product Inserts stated that there is ‘no viral DNA’ in the Gardasil vaccine. That is until April 2011 – when the line was glaringly absent from U.S. product inserts.

    I like the filthy pig comment also. This is a very colorful thread.
     
  15. Anonymous

    Anonymous Guest

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

    They got the injection years ago during the trial study. Why do you think they don't do anything and collect a paycheck.
     
  16. Anonymous

    Anonymous Guest

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

    Where did you acquire this information? It's easily perceived and understood you are or were employed at Merck. Such knowledge of specific and timely events or situations clearly should not be communicated in any format. There is no merit to such a declaration and should not be perceived as fact.
     
  17. Anonymous

    Anonymous Guest

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

    what does that mean? I don't understand the quote and I really don't understand the reply to the quote. I got where did you get that infomation part but that's about it.
     
  18. Anonymous

    Anonymous Guest

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

    What a silly comment. Gardasil product information is all over internet, and in way back machine.

    Doesn't take a genius to find it all, just someone using a mouse in Google.

    It's pretty obvious when you look back through all the years of information that something is up - when all American product material suddenly dropped the no dna bit earlier this year.

    Maybe QA actually realised something was wrong, and was doing a CMA.
     
  19. Anonymous

    Anonymous Guest

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

    Quite possibly the DNA is present at very low (formerly undetectable?) levels and always has been. But maybe someone finally got sufficiently interested in developing a better test. If the DNA is now being found because of a more efficient test, one might safely bet that the test was not developed or applied due to Merck's initiative. Not looking for trouble when they ought to defines Merck (and most of pharma today) and particularly Merck's QA. Taking potential contamination references out of inserts isn't going to happen without FDA approval. If this insert statement is a fact, where was the FDA in all this?
     
  20. Anonymous

    Anonymous Guest

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

    European Medicine Agency Pag. 6

    Mechanism of Action
    Gardasil is an adjuvanted non-infectious recombinant quadrivalent vaccine prepared from the highly
    purified virus-like particles (VLPs) of the major capsid L1 protein of HPV types 6, 11, 16 and 18. The
    VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease. HPV only infects
    humans, but animal studies with analogous papillomaviruses suggest that the efficacy of LI VLP
    vaccines is mediated by the development of a humoral immune response.
    http://www.ema.europa.eu/docs/en_GB...duct_Information/human/000703/WC500021142.pdf


    SANOFI Pasteur MSD Pag. 6

    Mechanism of Action
    Gardasil is an adjuvanted non-infectious recombinant quadrivalent vaccine prepared from the highly
    purified virus-like particles (VLPs) of the major capsid L1 protein of HPV types 6, 11, 16 and 18. The
    VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease. HPV only infects
    humans, but animal studies with analogous papillomaviruses suggest that the efficacy of LI VLP
    vaccines is mediated by the development of a humoral immune response.

    http://www.spmsdregistregrossesses.com/Published/pdf/SmPC_Gardasil.pdf

    Merck pag 14

    Mechanism of Action
    HPV only infects human beings. Animal studies with analogous animal papillomaviruses suggest that
    the efficacy of L1 VLP vaccines may involve the development of humoral immune responses. Human
    beings develop a humoral immune response to the vaccine, although the exact mechanism of protection
    is unknown.

    http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf

    Merckfrosst Canada Pag 20

    Mechanism of Action
    GARDASIL® contains L1 VLPs, which are proteins that resemble wild-type virions. Because the
    virus-like particles contain no viral DNA, they cannot infect cells or reproduce.
    HPV only infects humans, but animal studies with analogous animal papillomaviruses suggest
    that the efficacy of L1 VLP vaccines is mediated by the development of humoral immune
    responses.

    http://www.merckfrosst.ca/assets/en/pdf/products/GARDASIL-PM_E.pdf