Adventures in Autism

#1 09-07-2011, 06:12 PM

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

Merck has become a 3rd world pharmaceutical company.

#3 09-07-2011, 10:35 PM

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

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

Oh shit, here we go again.

#6 09-07-2011, 11:11 PM

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

#7 09-07-2011, 11:17 PM

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

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

#9 09-08-2011, 08:25 AM

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

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

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

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

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

#14 09-08-2011, 10:31 PM

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

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

#16 09-09-2011, 12:55 PM

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

#47 09-13-2011, 08:18 PM

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

#48 09-13-2011, 10:00 PM

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

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

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?

#51 Yesterday, 10:05 AM

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

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

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

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

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

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

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

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

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

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

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

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.

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