Offit/Crosby

So strange.

Jake Crosby has been dissecting autism research, writing about vaccine injury and exposing corruption and conflicts of interests in vaccine apologists for what, four years now?  And suddenly, in the course of three weeks, he has been branded so dangerous that he must be physically removed from not one, but two separate lectures by vaccine industry defenders... after merely asking a legitimate questions, both about Andrew Wakefield?

First Seth Mnookin said he was a heckler, but now wont answer questions or offer details about said heckling.  Now Paul Offit has upped the ante and announced that Jake was his stalker.

So as with Mnookin, I have written to Dr. Offit and asked him for details of Jake's problematic behavior.  You may recognize much of the letter, as I merely modified the letter I sent to Mnookin a few weeks ago, as this is practically the identical scenario that happened a few weeks ago.

-------- Original Message --------

Subject:	Jake Crosby
Date:	Tue, 27 Dec 2011 18:40:00 -0500
From:	Ginger Taylor
To:	Paul Offit

Dr. Offit,

I read Jake Crosby's story on being ejected from your most recent event after asking a question during the question and answer period.

From his telling of the story, what you did seems to me be very heavy handed and inappropriate at the least, and some pretty ugly censorship and slander on your part at most.

As you have been untruthful about offenses that were never committed by your opponents in the past, (I reference JB Handley's successful libel lawsuit against you and the Orange County Register's retraction of your charges against a CBS reporter when you were unable to back them up), I tend to believe Jake's story on its face, but I want to allow for the fact that Jake did not report the incident accurately, thus my reason for contacting you with a few questions.

1.  Did he accurately report the incident, and that he has only been in contact with you once before, two years ago, via email?

2.  If so, do you not believe that an apology to him is in order?

3.  If he did not report the incident accurately, what did he get wrong?

4.  If not, what was the "stalking" incident or incidents that you referred that previously took place and why did it preclude him from asking a non-stalking question at this event?  When and where did it take place, what was said, what administrative or security action was taken, and are there recordings of any such events?

5.  Is Jake precluded from asking you questions in the future?  Is he precluded from attending any of your speaking engagements in the future?  Have you given him any notice to stay away, or a cease and desist or has any form of restraining order been issued?

6.  Like Jake, I have been very critical of your writing in my own blogging.  Am I allowed to attend your events and ask you questions?  If so what are the parameters for asking you questions and do they differ from someone who might agree with you on your vaccine stance?

7.  Is there anyone else from the autism, vaccine injury, vaccine safety or anti-vaccine communities, or from the medical community that is skeptical of the safety and efficacy claims made about the current vaccine program, that are not allowed to attend your events or ask you questions?

8.  Finally, (and with brutal frankness) If Mr. Crosby's story is accurate, and he has been appropriate in his interactions with you, and your own desire to silence your challengers is at the heart of why you had him removed from the room, is this a pattern you intend to continue?  Can anyone asking you a question which you believe you will not not be able to answer well, or which might make you look bad in front of the audience, expect to be slandered and escorted from the room?

9.  As Seth Mnookin made similar charges against Jake earlier this month, have you been communicating with him about Jake, and is this a coordinated effort to slander him?

I want to get this cleared up as people have expressed in increasing interest in attending your speaking events and challenging your assertions, many of which (myself included) believe are grossly inaccurate and/or irresponsible.  We certainly want to know up front if you intend on misrepresenting any of us as you seem to have done with Jake or if it is Jake who is misrepresenting you.

Your prompt response is appreciated.

--

Ginger Taylor
Adventures In Autism
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818-402-9672

Does Geri Dawson Know What Glutathone Is?

Interesting story...

I was speaking with an autism researcher who told me about an exchange he had with Geri Dawson, the chief science officer for Autism Speaks.  He attended an AS reception at a university and approached Dr. Dawson to ask her what she thought about the research surrounding glutathione and autism.  Dr. Dawson replied that she was not familiar with gluthathione/autism research.

There are 12 studies on GSH and Autism (all of which I have listed below) and all of them have found low glutathione problems are tied to autism.

My son was diagnosed with autism in the spring of 2004, and I became familiar with glutathione/autism research before the summer was out.  I believe it is absolutely unacceptable for the "science officer" of Autism Speaks, whom GQ declared one of the "Rock Stars of Science," to not be intimately familiar with what may be one of the most key aspects of why our children as so susceptible to environmental injury, low glutathione levels that leave our children unable to detox.

And as Autism Speaks has highlighted in their own "AUTISM SPEAKS TOP 10 AUTISM RESEARCH ACHIEVEMENTS OF 2011" Autism is a condition brought on by environmental exposures.  And being that one of the GSH/autism studies was actually funded by Autism Speaks, again... no reason that Dawson should not be all over this.

The possibility that Dr. Dawson could not even offer a basic response on a question about glutathione, to put in mildly, troubles me.  The fact that she believes that she is qualified to be directing autism research, knowing so little about this environmental illness, makes me angry.  The fact that Geri Dawson has applied to be on the IACC makes me crazy.  Because with her title, and her "Rock Star" PR, she might just be added to it by Thomas Insel.

Just to be sure that I had my fact straight about Dr. Dawson's response to the GSH question.  I wrote to her to confirm:

Subject:	Glutathione
Date:	Tue, 15 Nov 2011 10:59:06 -0500
From:	Ginger Taylor
To:	Geri Dawson

Dr. Dawson,

I am writing a piece on you and would like your response before I publish.

I spoke with a researcher who reports approaching you at an AS reception earlier this year and asking you about glutathione research.  He told me that you said were not familiar with research on glutathione. 

As the glutathione connection in autism is a foundational one to understanding why these particular children are vulnerable to environmentally caused autism (including vaccine induced autism, which you continue to deny despite the evidence HRSA's own admission that vaccine induced encephalopathy can cause autism, and that they list the symptoms of autism on the VICP injury table), and as it is among the first interventions that families implementing biomedical intervention for autism learn about, you can see how alarming that AS's chief science officer seems to have no knowledge of its role in autism causation or treatment. 

I will be writing about this exchange, but wanted to give you a chance to comment before I publish. 

When you were approached about glutathione, did you have any understanding of its role in autism?  What is your understanding now?  Since every study done on GSH and autism has found a link, and since AS has actually funded research on GSH, it is appropriate for AS to have a science officer who is not conversant on it?

Thank you,

--

Ginger Taylor
Adventures In Autism
Facebook
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Vaccine Epidemic
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That was more than a month ago, and no response.

So what does Dr. Dawson actually know about this environmental illness?  A comment she made on her "Rock Stars of Science" interview might give us a hint.

"Best moment in medicine/research: Recently, my colleagues and I published the first randomized clinical trial showing very positive benefits of early intervention for toddlers with autism. The moment I saw the results of that study was one of the best moments of my research career."

Dr. Dawson's best moment in research was when she confirmed what we have known for probably twenty years, but the fact that children might be prevented from needing that early intervention in the first place simply by testing infant glutathione levels... completely lost on her?

Listing the GSH research for Dr. Dawson in the hopes that she will review it and realize that she might have a chance to prevent the boat from developing a hole it in, rather than having to spend a lifetime bailing it out.


1. Nutritional and Metabolic Status of Children with Autism vs. Neurotypical Children, and the Association with Autism Severity. Adams JB, Audhya T, McDonough-Means S, Rubin RA, Quig D, Geis E, Gehn E, Loresto M, Mitchell J, Atwood S, Barnhouse S, Lee W. Nutr Metab (Lond). 2011 Jun 8;8(1):34.

2. The severity of autism is associated with toxic metal body burden and red blood cell glutathione levels. Adams JB, Baral M, Geis E, Mitchell J, Ingram J, Hensley A, Zappia I, Newmark S, Gehn E, Rubin RA, Mitchell K, Bradstreet J, El-Dahr JM. J Toxicol. 2009;2009:532640.

3. Novel plasma phospholipid biomarkers of autism: mitochondrial dysfunction as a putative causative mechanism. Pastural E, Ritchie S, Lu Y, Jin W, Kavianpour A, Khine Su-Myat K, Heath D, Wood PL, Fisk M, Goodenowe DB. Prostaglandins Leukot Essent Fatty Acids. 2009 Oct;81(4):253-64.

4. Metabolic biomarkers related to oxidative stress and antioxidant status in Saudi autistic children. Al-Gadani Y, El-Ansary A, Attas O, Al-Ayadhi L. Clin Biochem. 2009 Jul;42(10-11):1032-40.

5. One carbon metabolism disturbances and the C677T MTHFR gene polymorphism in children with autism spectrum disorders. Paşca SP, Dronca E, Kaucsár T, Craciun EC, Endreffy E, Ferencz BK, Iftene F, Benga I, Cornean R, Banerjee R, Dronca M. J Cell Mol Med. 2009 Oct;13(10):4229-38.

6. Efficacy of methylcobalamin and folinic acid treatment on glutathione redox status in children with autism. James SJ, Melnyk S, Fuchs G, Reid T, Jernigan S, Pavliv O, Hubanks A, Gaylor DW. Am J Clin Nutr. 2009 Jan;89(1):425-30.

7. Biomarkers of environmental toxicity and susceptibility in autism. Geier DA, Kern JK, Garver CR, Adams JB, Audhya T, Nataf R, Geier MR. J Neurol Sci. 2009 May 15;280(1-2):101-8.

8. A prospective study of transsulfuration biomarkers in autistic disorders. Geier DA, Kern JK, Garver CR, Adams JB, Audhya T, Geier MR. Neurochem Res. 2009 Feb;34(2):386-93.

9. Abnormal transmethylation/transsulfuration metabolism and DNA hypomethylation among parents of children with autism. James SJ, Melnyk S, Jernigan S, Hubanks A, Rose S, Gaylor DW. J Autism Dev Disord. 2008 Nov;38(10):1966-75.

10. A case series of children with apparent mercury toxic encephalopathies manifesting with clinical symptoms of regressive autistic disorders. Geier DA, Geier MR. J Toxicol Environ Health A. 2007 May 15;70(10):837-51.

11. Metabolic endophenotype and related genotypes are associated with oxidative stress in children with autism. James SJ, Melnyk S, Jernigan S, Cleves MA, Halsted CH, Wong DH, Cutler P, Bock K, Boris M, Bradstreet JJ, Baker SM, Gaylor DW. Am J Med Genet B Neuropsychiatr Genet. 2006 Dec 5;141B(8):947-56.

12. Metabolic biomarkers of increased oxidative stress and impaired methylation capacity in children with autism. James SJ, Cutler P, Melnyk S, Jernigan S, Janak L, Gaylor DW, Neubrander JA. Am J Clin Nutr. 2004 Dec;80(6):1611-7.

Mnookin/Crosby

Update: December 19th. One week out, and other than an auto reply, no response. Not even an "It's the holidays and I am knitting sweaters with my grandma, will get back to you in the new year."

Seth,

I read Jake's story on being ejected from your most recent event after asking a question during the question and answer period.

From his telling of the story, what you did seems to me be very heavy handed and inappropriate at the least, and some pretty ugly censorship and cowardice on your part at most.

As you have censored my own comments on your blog in the past, and have stated outright that you wish that David Kirby would be censored in his vaccine writing, I tend to believe Jake's story on its face, but I want to allow for the fact that Jake did not report the incident accurately, thus my reason for contacting you with a few questions.

1.  Did he accurately report the incident?

2.  If so, do you not believe that an apology to him is in order?

3.  If he did not report the incident accurately, what did he get wrong and is there a recording of the event?

4.  If so, what was the "heckling" incident that you referred to at a previous event and why did it preclude him from asking a non-heckling question at this event?  When and where did it take place, what was said, what administrative or security action was taken, and is there a recording of that event?

5.  Is Jake precluded from asking you questions in the future?  Is he precluded from attending any of your speaking engagements in the future?  Have you given him any notice to stay away, or a cease and desist or has any form of restraining order been issued?

6.  Like Jake, I have been very critical of your writing in my own blogging.  Am I allowed to attend your events and ask you questions?  If so what are the parameters for asking you questions and do they differ from someone who might agree with you on your vaccine stance?

7.  Is there anyone else from the autism, vaccine injury, vaccine safety or anti-vaccine communities, or from the medical community that is skeptical of the safety and efficacy claims made about the current vaccine program, that are not allowed to attend your events or ask you questions?

8.  Finally, (and with brutal frankness) If Mr. Crosby's story is accurate, and he has been appropriate in his actions at your events, and your own desire to silence your challengers is at the heart of why you had him removed from the room, is this a pattern you intend to continue?  Can anyone asking you a question which you believe you will not not be able to answer well, or which might make you look bad in front of the audience, expect to be slandered and escorted from the room?

I want to get this cleared up as people have expressed in increasing interest in attending your speaking events and challenging your assertions, many of which (myself included) believe are grossly inaccurate and/or irresponsible.  We certainly want to know up front if you intend on misrepresenting any of us as you seem to have done with Jake or if it is Jake who is misrepresenting you.

Your prompt response is appreciated.

--

Ginger Taylor
Adventures In Autism
Facebook
Twitter
Vaccine Epidemic
818-402-9672

Thimerosal Gives Baby Rats Brain Damage

Lasting neuropathological changes in rat brain after intermittent neonatal administration of thimerosal.

Folia Neuropathol. 2010;48(4):258-69.  Olczak M, Duszczyk M, Mierzejewski P, Wierzba-Bobrowicz T, Majewska MD.

Department of Pharmacology and Physiology of the Nervous System, Institute of Psychiatry and Neurology, ul. Sobieskiego 9, Warsaw, Poland.

Abstract
Thimerosal, an organomercurial added as a preservative to some vaccines, is a suspected iatrogenic factor, possibly contributing to paediatric neurodevelopmental disorders including autism. We examined the effects of early postnatal administration of thimerosal (four i.m. injections, 12 or 240 μg THIM-Hg/kg, on postnatal days 7, 9, 11 and 15) on brain pathology in Wistar rats. Numerous neuropathological changes were observed in young adult rats which were treated postnatally with thimerosal. They included: ischaemic degeneration of neurons and "dark" neurons in the prefrontal and temporal cortex, the hippocampus and the cerebellum, pathological changes of the blood vessels in the temporal cortex, diminished synaptophysin reaction in the hippocampus, atrophy of astroglia in the hippocampus and cerebellum, and positive caspase-3 reaction in Bergmann astroglia. These findings document neurotoxic effects of thimerosal, at doses equivalent to those used in infant vaccines or higher, in developing rat brain, suggesting likely involvement of this mercurial in neurodevelopmental disorders.

J Inorg Biochem. 2011 Nov;105(11):1489-99. Epub 2011 Aug 23.

Do aluminum vaccine adjuvants contribute to the rising prevalence of autism?

Tomljenovic L, Shaw CA.

Source

Neural Dynamics Research Group, Department of Ophthalmology and Visual Sciences, University of British Columbia, 828 W. 10th Ave, Vancouver, BC, Canada V5Z 1L8.

Abstract
Autism spectrum disorders (ASD) are serious multisystem developmental disorders and an urgent global public health concern. Dysfunctional immunity and impaired brain function are core deficits in ASD. Aluminum (Al), the most commonly used vaccine adjuvant, is a demonstrated neurotoxin and a strong immune stimulator. Hence, adjuvant Al has the potential to induce neuroimmune disorders. When assessing adjuvant toxicity in children, two key points ought to be considered: (i) children should not be viewed as "small adults" as their unique physiology makes them much more vulnerable to toxic insults; and (ii) if exposure to Al from only few vaccines can lead to cognitive impairment and autoimmunity in adults, is it unreasonable to question whether the current pediatric schedules, often containing 18 Al adjuvanted vaccines, are safe for children? By applying Hill's criteria for establishing causality between exposure and outcome we investigated whether exposure to Al from vaccines could be contributing to the rise in ASD prevalence in the Western world. Our results show that: (i) children from countries with the highest ASD prevalence appear to have the highest exposure to Al from vaccines; (ii) the increase in exposure to Al adjuvants significantly correlates with the increase in ASD prevalence in the United States observed over the last two decades (Pearson r=0.92, p<0.0001); and (iii) a significant correlation exists between the amounts of Al administered to preschool children and the current prevalence of ASD in seven Western countries, particularly at 3-4months of age (Pearson r=0.89-0.94, p=0.0018-0.0248). The application of the Hill's criteria to these data indicates that the correlation between Al in vaccines and ASD may be causal. Because children represent a fraction of the population most at risk for complications following exposure to Al, a more rigorous evaluation of Al adjuvant safety seems warranted.

Dear Autism

Dear Autism,

Today you kicked the neighbor, colored on the walls, overturned chairs and ripped pillows to shreds.  You launched off countertops, scratched my son's legs bloody, spit on the mirrors and windows.  You eliminated all the food my son tried to digest in the form of black paste.  You took bite after bite of an apple, spit the fruit meat into the air, then smeared it into my son's hair and face.  You took his speech and replaced it with two solid hours of blood curdling screams. You attempted to break down the front and side doors with all your might.  You opened the car door while our vehicle was in motion, risking the lives of everyone on board.  I know now, a five point harness means nothing to you. You threw family photos across the room and held the shattered glass right next to my son's beautiful brown eyes.  The eyes, you and the Rubella virus are destroying just a tiny bit more with each passing day.  Worst of all, you took my son's joy.  Our Noah is delightful, kind-hearted and loving.  I know you laughed when his three year old brother Liam, shook, screamed and cried, "I hate it!  Make it stop Mommy!  I...I...I hate him!"   I think you particularly enjoyed that.  Let me tell you something.  I know who sent you.  A rapidly growing subculture of intelligent and professional parents around the country know too.  We know about the select few, growing richer and richer, profitting immensely off of a generation of chronically ill children that just "happened."  We understand the legislation that caused this, the motives of doctors turning a bind eye to it, and the politicians and capitalists benefitting from it.

If you are wondering, this peaceful moment for me to write was made possible because the effects from the levo-carnitine our precious Noah needs to take to counteract the effects of the  mitochondrial disease you caused are finally starting to wear off.  Instead of kicking, hitting, screaming and trying to escape the house, he is simply running, spinning and spitting.  Yes, this constitutes, "a peaceful moment".  So friends, please send this to everyone you know who many have a family history of allergies, asthma, autoimmune disease or ADHD.   You could save their children's lives.  I know with all that I am that Noah wants to spare every human possible the pain and suffering he endures daily.  I too, do this not to cause fear or vent--I do it to EDUCATE.  I do not want to rob you of your sense of safety and well being.  On the contrary, I want to provoke you to become a specialist in your child's health.  I have in my possession over 30 studies that show the link between autism and vaccines must be further investigated.  I would be delighted to send them to you.

Best, LJ Goes 

Apparently Your Tongue Goes Down Your GI Tract and Up To Your Brain

J Pediatr Gastroenterol Nutr. 2011 Aug 8. [Epub ahead of print]

From The Tongue To The Gut.

Negri R, Morini G, Greco L.

* European Laboratory for Food Induced Diseases, University of Naples Federico II, Naples, Italy † University of Gastronomic Sciences, Pollenzo-Bra (CN), Italy.
Abstract

ABSTRACT: The physiology of human taste enjoyed an unprecedented expansion of knowledge brought forward by modern genetics and molecular biology. In the last 10 years the cellular organization of taste receptors from taste buds distributed in the various papillae of the tongue and the soft palate was enlightened. This molecular revolution rapidly expanded over and above the tongue, since several papers reporting the presence of taste receptors in non-gustatory tissues (like the gut and the brain) appeared. Hence the issue of perception of food molecules is not anymore confined to the field of nutrition and food preferences, but is rapidly expanding to gastrointestinal function and, possibly, to gut dysfunction too. In children functional gastrointestinal diseases are strictly correlated to food preference and food aversion and up to now the tools to face these kind of problems were the basic nutritional requirements, familial good sense and a lot of patience: blunt tools to face very common and disturbing complaints. The fact that taste receptors are expressed down the whole of intestinal tract is of particular interest, because of their possible role in digestive behavior and absorption of nutrients; therefore recent and future discoveries in this field will make possible to fine-tune new, sharper tools to face children with functional gastrointestinal diseases.

PMID:

 

21832948

 

[PubMed - as supplied by publisher]

What Do Merck Employees Think of the SANE Vax Discovery of Gardasil Contamination

No reaction from official channels on S.A.N.E. Vax's find of genetically modified HPV DNA that is in the Gardasil vaccine and one of its victims blood.... even though it not supposed to be in either. 


But Merck employees are commenting.  Anonymously of course on Cafe Pharma (the table below is all wonky and I am too tired to fix it... so go to the source to read).  This is indicative of the sentiment:

"charred saran wrap, now this...I gotta get another job"

"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 deserves."

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

"When do we understand that something is wrong and needs to be fixed?"

"The most depressing thing about these posts is that none of us are surprised that this happened...maybe it's time to cut the cord."

When your own employees call you corrupt, you are corrupt.


The entire thread for your reading pleasure:

Cafepharma Message Boards > Company Boards > Merck  SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil To ..

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#1    09-07-2011, 06:12 PM

Anonymous Posts: n/a

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

#2    09-07-2011, 06:47 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Merck has become a 3rd world pharmaceutical company.

#3    09-07-2011, 10:35 PM

Anonymous Posts: n/a

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    09-07-2011, 10:52 PM

Anonymous Posts: n/a

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    09-07-2011, 10:56 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Oh shit, here we go again.

#6    09-07-2011, 11:11 PM

Anonymous Posts: n/a

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    09-07-2011, 11:17 PM

Anonymous Posts: n/a

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    09-08-2011, 07:14 AM

Anonymous Posts: n/a

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    09-08-2011, 08:25 AM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  Let's face it, Merck has never been honest when it comes to this vaccine. Besides that, Merck does not know what the hell is going on with production.

#10    09-08-2011, 09:39 AM

Anonymous Posts: n/a

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    09-08-2011, 12:49 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  With all the manufacturing issues......why does Willie Deese still have a position in this company. He should have been sh**canned years ago. 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,Q A,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,Q A,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    09-08-2011, 01:42 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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. 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    09-08-2011, 10:23 PM

Anonymous Posts: n/a

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    09-08-2011, 10:31 PM

Anonymous Posts: n/a

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    09-09-2011, 10:36 AM

Anonymous Posts: n/a

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    09-09-2011, 12:55 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  Let's face it, Merck has never been honest when it comes to this vaccine. 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    09-09-2011, 05:16 PM

Anonymous Posts: n/a

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    09-09-2011, 07:01 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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. 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    09-09-2011, 11:38 PM

Anonymous Posts: n/a

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    09-10-2011, 08:41 AM

Anonymous Posts: n/a

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.

#21    09-10-2011, 09:18 AM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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. Dick Clark held a clipboard and watched tablets being pressed in the 70's at Elkton. Rightly or wrongly, at that site (primarily active ingredient site) those guys in the drug product building were considered to be a cut below the average talent level in MCMD. He is background is very much like a lot of others; university degree, military training, keep the troops and the conveyers running. That's about as far from the art of pharmaceutical manufacturing as you can get. But it forever qualified him as solidly grounded in manufacturing. There are a lot of other leaders in lots of other areas at Merck with similarly shallow resumes that are making decisions for which their vaunted experience is insufficient. It is part of the curse of Merck's golden boy talent process. Pass through quickly on your way and keep leave it behind is the usual track record for the leadership team. If they think heard enough they actually might remember someone from their past that actually did know something useful. And this rapid, shallow leader development is not only in the pharma industry.

#22    09-10-2011, 04:59 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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. Merck does have a history of hiring pretty good R&D people. The problem is the people around R&D have no clue how to run or manage anything. I don't like the way the post was written but I agree with the subject matter within the words.

#23    09-10-2011, 08:27 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T The most depressing thing about these posts is that none of us are surprised that this happened...maybe it's time to cut the cord.

#24    09-10-2011, 09:43 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T how does Willie Deese still have a job? They should cut him and the whole QA crew. If anything should be outsourced that is it. Things can't get any worse. Have you ever tried to have a conversation with anyone from QA in NJ? I have and you wonder how they were ever hired in the first place. Total garbage at best. They did not get their jobs because of intellect. There has to be another reason (wink, wink)

#25    09-10-2011, 10:36 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Willie Deese's job is to outsource as much manufacturing as possible. He can't wait until these sorts of things happen only to external manufacturers.

#26    09-10-2011, 11:40 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T He is a dummy. Manufacturing is only as good as the process and how well quality control detects and corrects issues. If the process and QA is horrible (like it is now) outsourcing will not fix anything. Get competent people in QA and hire experts who know process and outsourcing will not be needed. In the old days everyone at Merck was the best in class regardless of the position. Now we have fools in important positions (QA) that give upper management (fools also) an excuse to move jobs elsewhere. HR, PLEASE READ: clip QA before your job gets outsourced also.

#27    09-11-2011, 08:08 AM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T The last thing sweet willie would want is accountable people in QA. There is a good chance that he put the most incompetence people there on purpose so the outsourcing can be done quicker. It's called the scorched earth way of managing.

#28    09-11-2011, 03:06 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T I've seen it firsthand - QA spends more of their energy figuring out how to get questionable stuff released than it does getting problems properly fixed so that they will not re-occur. Of course, QA has lots of rules and regulations and SOPs but when push comes to shove, management can always get objections swept aside. If the leaders of the manufacturing group actually had really useful prior experience, they would be 10 X more efficient at spotting serious issues than any outside auditor. And formerly with Merck, if your management spotted deficiencies in your area, such a discovery could be career-threatening. But those outside auditors still are finding things so it must mean only one of three things: The management are clueless about the people, facilities, products, processes, and systems they manage; management is not spending any time looking for deficiencies; or management just doesn't care. Or perhaps all three? God help the general public when its products get 100% supplied from the outside - under (by then) even more under-informed, absentee dimwitted Merck "vigilance". Merck now sells what provides profitable self-convenience - not any real quality.

#29    09-11-2011, 09:47 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  I've seen it firsthand - QA spends more of their energy figuring out how to get questionable stuff released than it does getting problems properly fixed so that they will not re-occur. Of course, QA has lots of rules and regulations and SOPs but when push comes to shove, management can always get objections swept aside. If the leaders of the manufacturing group actually had really useful prior experience, they would be 10 X more efficient at spotting serious issues than any outside auditor. And formerly with Merck, if your management spotted deficiencies in your area, such a discovery could be career-threatening. But those outside auditors still are finding things so it must mean only one of three things: The management are clueless about the people, facilities, products, processes, and systems they manage; management is not spending any time looking for deficiencies; or management just doesn't care. Or perhaps all three? God help the general public when its products get 100% supplied from the outside - under (by then) even more under-informed, absentee dimwitted Merck "vigilance". Merck now sells what provides profitable self-convenience - not any real quality. The issues is QA is a group of people who really don't have what it takes to do such an important job. I don't think they even understand or even care that they can destroy someones life or worse yet a child's. They have a black heart and no soul if they would move a dirty product because they are scared. Old Merck people did what was right and we had a good reputation. Now we are spineless cowards who would put people in harms way for the dollar. I hate to write it but maybe the words cowards and c*nts do describe the Merck QA department.

#30    09-11-2011, 11:25 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Let me help, Willie A Deese started around 2004 at Merck. He is as dumb as a stump. He had to find people less intelligent than himself so he hired complete morons. Then in 2009 the merger happened. SP had plenty of complete idiots who fit that description in QA (especially at Kenilworth headquarters). He wants the process to fail because his game plan is to move all manufacturing outside the USA. The QA people are too stupid to understand that the more bad press we receive, the quicker it will happen. They will be out of work also.

#31    09-12-2011, 07:52 AM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T The problems at West Point started well before Willie Deese arrived. This is not to say that Willie has the vision it takes to reverse the situation. I would say the erosion of the manufacturing operations started sometime after the ambitious middle management abandoned West Point and Rahway so they could spend time kissing ass in the New Jersey countryside at Whitehouse Station. This change in emphasis soon converted the formerly competent operations groups into transfer lounges for PowerPoint-pushing self-promoters. QA problems are like children run wild problems. Absentee (or utterly ignorant) parents and babysitters.

#32    09-12-2011, 11:56 AM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T I would love to know the interview process for QA. Finding people more lazy, ignorant, and clueless than Willie is hard to find. I guess they just took the pulse of a candidate and if it came up positive, they were hired. I would love to see how QA managers and workers will find a job after Merck after they are let go.

#33    09-12-2011, 01:20 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  I would love to know the interview process for QA. Finding people more lazy, ignorant, and clueless than Willie is hard to find. I guess they just took the pulse of a candidate and if it came up positive, they were hired. I would love to see how QA managers and workers will find a job after Merck after they are let go. Sad but true. They also probably kept those at Schering who had major problems of their own to help enhance our processes.

#34    09-12-2011, 03:49 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  The issues is QA is a group of people who really don't have what it takes to do such an important job. I don't think they even understand or even care that they can destroy someones life or worse yet a child's. They have a black heart and no soul if they would move a dirty product because they are scared. Old Merck people did what was right and we had a good reputation. Now we are spineless cowards who would put people in harms way for the dollar. I hate to write it but maybe the words cowards and c*nts do describe the Merck QA department. I don’t really care about how they live with themselves or how they sleep at night knowing the people they hurt. I care about the dollar. We have been through tough times before and have always managed to succeed because our reputation was so good. If a customer had a choice of 2 similar drugs we always won outright because we were a safe and reliable company. Because QA and all there major issues we do not have the customers confidence. 15 years ago we would have 90% of the hep-c market just because of who we were. Because of the major screw-ups in production and QA in a comatose state , we have little crap companies take us to the woodshed because we lost the customers confidence in who we are. I have been here 32 years and we used to steamroll all the other companies because our house was in order. Now, as the comic book pogo said “"We have met the enemy and he is us." I guess the pogo comic strip shows my age.

#35    09-12-2011, 06:48 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  I don’t really care about how they live with themselves or how they sleep at night knowing the people they hurt. The people who lie awake at night are the parents of the girls that are hurt. Does anybody here has an idea of what they are going through?? It is not only about production and sales, but also about the harm that has been done.

#36    09-12-2011, 08:26 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T How do we look the mothers in the eye when we know that we are injuring their children. When did we as a company stop caring. What is wrong with this picture. Our products are supposed to help, not harm. What is going to happen when these teenagers realize that Gardasil is what is injuring them and it is because there is trash in the vaccine? First Burnt Plastic, now recombinant HPV DNA.

#37    09-12-2011, 08:42 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T That is why they are a bunch of disgusting human being. I know the fat blond one in NC was let go. What a B*tch.

#38    09-12-2011, 10:38 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  How do we look the mothers in the eye when we know that we are injuring their children. When did we as a company stop caring. What is wrong with this picture. Our products are supposed to help, not harm. What is going to happen when these teenagers realize that Gardasil is what is injuring them and it is because there is trash in the vaccine? First Burnt Plastic, now recombinant HPV DNA. I am in sales or a rep or whatever you want to call me. I love how people think we are the horrible and over-payed people. Now that I think about it, QA are truly scourge of the earth. I just can't imagine how the parent feel right now because QA is such a group of incompetent people. Is it worth the $$$ to, I don't feel like typing

#39    09-12-2011, 11:39 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  I am in sales or a rep or whatever you want to call me. I love how people think we are the horrible and over-payed people. Now that I think about it, QA are truly scourge of the earth. I just can't imagine how the parent feel right now because QA is such a group of incompetent people. Is it worth the $$$ to, I don't feel like typing The QA department should be fired “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 100% results from 13 different lots. Gardasil is not supposed to have any whole virus. It might trigger some of the autoimmune-based inflammatory disorders and malignant tumors observed among children/young women after receiving Gardasil.

#40    09-13-2011, 08:18 AM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Wake up people. Merck cheats in all aspects of the business. Tax, sales, production, R&D, clinical filing. The data is just too consistent to think that Billion-dollar fines for tax evasion, Medicare fraud, Consent Decrees, HPV contamination, and Vioxx are isolated incidents. Better perfect your cheating skills and get with the program or get the hell out. New Merck's reputation is 180 degrees away from its legacy namesake's reputation.

#41    09-13-2011, 09:11 AM

Anonymous Posts: n/a

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.

#42    09-13-2011, 10:29 AM

Anonymous Posts: n/a

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.

#43    09-13-2011, 01:57 PM

Anonymous Posts: n/a

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.

#44    09-13-2011, 04:45 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  how does Willie Deese still have a job? They should cut him and the whole QA crew. If anything should be outsourced that is it. Things can't get any worse. Have you ever tried to have a conversation with anyone from QA in NJ? I have and you wonder how they were ever hired in the first place. Total garbage at best. They did not get their jobs because of intellect. There has to be another reason (wink, wink) 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.

#45    09-13-2011, 06:29 PM

Anonymous Posts: n/a

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.

#46    09-13-2011, 08:16 PM

Anonymous Posts: n/a

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.

#47    09-13-2011, 08:18 PM

Anonymous Posts: n/a

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

#48    09-13-2011, 10:00 PM

Anonymous Posts: n/a

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.

#49    Yesterday, 12:08 AM

Anonymous Posts: n/a

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.

#50    Yesterday, 09:56 AM

Anonymous Posts: n/a

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?

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#51    Yesterday, 10:05 AM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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. 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?

#52    Yesterday, 10:12 AM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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. 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).

#53    Yesterday, 01:55 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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. 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.

#54    Yesterday, 02:46 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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). 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.

#55    Yesterday, 05:24 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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. They got the injection years ago during the trial study. Why do you think they don't do anything and collect a paycheck.

#56    Yesterday, 11:29 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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. 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.

#57    Yesterday, 11:48 PM

Anonymous Posts: n/a

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.

#58    Yesterday, 11:59 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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. 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.

#59    Today, 07:26 AM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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. 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?

#60    Today, 08:58 AM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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. 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/...C500021142.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.c...C_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_...ardasil_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/...DASIL-PM_E.pdf

#61    Today, 12:41 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T Quote: Originally Posted by Anonymous  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? Another silly question. Best person to ask is our current ex-CDC head of VD. How many of our top management comes from ex-regulators?... Of course FDA would know.

#62    Today, 02:33 PM

Anonymous Posts: n/a

Re: SANE Vax, Inc. Reports Human Papillomavirus (HPV) DNA Contamination in Gardasil T 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. This was not common information but easy to get. This was the same thing going around with the whole vioxx issue. The first thing that the lawyers do is a discovery process. Going through the internet, see what was sent out in order to find out what case Merck will have. The more information given, the harder the defense is. It's all about what you can hide and what the public thinks. Vioxx case had email issues and other information where they were posted on the web. This is some jerk off that is associated with Merck making some useless reminder about putting things on the web. Maybe Merck does not understand that we have many disgruntle employees who would love to stick it right up Merck’s ass. Also this is Anonymous.