TRUST MERCK ON VACCINES? READ THIS.

Still think vaccines are exempt from the dangerous vagaries of poppable pills? Think again. While the mainstream press (insert sneezing sound here - New York Times!) wants you to believe that drug manufacturers are scoundrels when it comes to prescription drugs and yet saints when it comes to vaccines, this report from The Philadelphia Inquirer says otherwise. Pretty brave reporting from a newspaper in a state where Pharma rules the day and the tax rolls.

Here's a snip. Read the full article HERE.

Federal inspectors documented unwanted "fibers" on the stoppers of vaccine vials at Merck & Co. Inc.'s vast vaccine plant in Montgomery County.

They also found instances of contaminated children's vaccines and complaints that were not always investigated at the West Point plant.

Inspectors from the U.S. Food and Drug Administration spent 30 days at the plant between November and January and cited 49 areas of concern, including a failure to follow good management practices.

Sammie Young, a retired FDA deputy director, inspected the West Point plant early in his career and for many years oversaw vaccine-plant inspections for the entire agency.

"There are a lot of violations there [in the report]," Young said, after reading the report. "I'm surprised."

He said vaccine-makers were supposed to investigate vaccine lots if their use was associated with a death or a life-threatening event.

Merck failed to investigate two such cases, the FDA report said. A patient treated with the pneumococcal vaccine Pneumovax developed a half-dollar-size abscess and needed intravenous antibiotics to contain the infection. A pregnant woman who took the HPV vaccine Gardasil lost her baby, the FDA report noted. The Gardasil packaging warns against its use for pregnant women.

Comments

[Terri Lewis]

Monica (and Kelli, elsewhere)--

Thanks for the "where you been!?" comments--nice to know when you're missed!

For what it's worth, I can't lay claim to whatever bright, witty (angry? over-the-top?) comments you're noticing on cafepharma, since I never post anonymously (or even with a pseudonym). . .keeps my less-than-better self in check. . .

Helps me to always know I'll have to take credit (or responsibility) for whatever I say publicly. . .

Terri Lewis

[Monica]

Does anyone find it coincidental that the FDA's report coincides with the media surrounding Hannah Poling, and all the recent vaccine safety meetings?

I don't find it coincidental AT ALL.

As always, I am a faithful reader of cafepharma, and have read some interesting things concerning Merck's vaccines being said by the reps themselves (the ones that are left, anyway). As in they have had NO varicella or mmr since the FDA report.

"Nobody bothers to turn on the lights for the vaccine packaging line most days because there is no bulk to pack. I'm told that the demand is there, but the supply is not. What exactly happened?"

Through the following Gardasil thread, I did learn that Merck should have filed VAERS for me, which they didn't (this is something they were cited for). I did thank the argumentative poster for the info, my atty (who also values cafepharma) will be interested in this! I wonder how many other AEs they ignored?

http://www.cafepharma.com/boards/showthread.php?t=283848

btw, welcome back Terri- where ya been? I usually can spot your comments on cafepharma :)

[Go FDA]

From the FDA website - http://www.fda.gov/cber/faq/merckqa.htm

"Are other Merck manufacturing facilities included in this warning letter?

No, only Merck's West Point, PA, manufacturing facility is subject to this Warning Letter."

Could it be because its the only facility the FDA looked at. Was it chosen because it was the premier facility? Shouldn't the FDA be looking at other facilities as well?

[Monica]

Merck receives ANOTHER warning letter about it's vaccines.

http://www.reuters.com/article/marketsNews/idUSN3030578520080430

http://www.fda.gov/cber/faq/merckqa.htm

[Sandy Gottstein]

Hi Rene,

Although I did read that interview, I must admit to giving it little stock. In my opinion, the fact that the interviewee refused to be identified gives it little credibility. It could be 100% true, but impossible to know.

And while it might be understandable (if not right, moral or ethical) that people who still work for a company might not want to come forward, I find it inexcusable (assuming this is a legitimate interview) that someone who knows what has gone on AND is retired would speak anonymously. I can't help but wonder if they thought they could relieve their guilt over knowing, by merely telling the story. Well, in my opinion, the guilt should still be there!

[Sandy Gottstein]

Jack,

Thanks for clarifying. We definitely agree that even if there was absolutely no contamination, there are other issues that create problems with vaccines, at least for some. Without properly conducted studies, of course, we do not know what the extent of the damage is. Moreover, without better understanding of the immune system and individual differences, tremendous potential risk will be taken without recognizing it.

And I hope you are right about them cleaning up the vaccines. But some things are hard to get rid of, and some things are there without our knowing it. There is also probably an inherent risk in using biologicals, regardless of our vigilance. Worse yet may be the assumption that was made that animal diseases could not be transmitted to humans. That notion should have been tested, not assumed, before generations of vaccines were blithely produced using animal cell cultures as the medium.

[Rene]

This is just a comment on whether the problem with vaccines is solely in their inherent design, or whether it can also be an issue of inadvertent contamination.

I'm sure Sandy and some others here have read the article "Vaccine Dangers and Vested Interests". A PDF is available for viewing here:

http://www.nexusmagazine.com/index.php?option=com_docman&task=cat_view&gid=31&Itemid=71

It is an anonymous interview with a retired vaccine researcher who worked at NIH and some major pharmaceutical companies. He talks in some detail about vaccine contamination in the lab, due to lab conditions and human error. It makes for some nauseous reading.

I first read this article two years ago, and haven't been able to stop thinking about it since.

[Jack]

Well, the industry really learned it's lesson from SV40 and it is a matter taken very seriously. The testing on new cell banks is incredibly intensive. It takes a long time and probably costs about $80,000. That's just for testing, not making it.

One important issue though, once you get a process approved you don't have to change it to follow newer regulations. So, as we learn more about safety, previous vaccines don't catch up. So, drugs made that we're originally licensed in say 1980 don't won't meet the current requirement for a new drug now. I'm familiar with the rules now, which are intense. I don't know what some other previous processes get away with that we wouldn't know. I know that in some cell culture process they used to use antibiotics in the media to prevent contamination. We can't get away with that now, which means your process has to be much much better to prevent a cell culture contamination with bacteria (which is dramatic and incredibly obvious and means instant loss of product). Using antibiotics you could mask a low level contamination and not see it.

I think in the end we'd debate two sides of the same coin. My point is that you could make a drug perfectly "pure" all the time, and that the industry and FDA is extremely serious in their pursuit of that goal (after all that is in their self-interest) and does a pretty good job at trying to get there, but still not have a "safe product." There are things we just don't understand yet about the human body, the immune system and the ecosystems inside us.

[Sandy Gottstein]

Jack,

I must respectfully disagree with you on the contamination point. Most contamination doesn't even get on the radar. It's a problem with cell cultures used in vaccine production. Please check out the links and my columns that I posted earlier in this thread.

And don't forget that when SV40 was found to contaminate the polio vaccine, rather than freak out the public over the vaccine, all remaining stocks were allowed to remain on the shelves. (See the excellent article by Nicholas Wade, Science, Division of Biologics Standards: The Boat That Never Rocked, vol. 175, pp.1225-1230, 1972).) From my perspective, this shows that their belief/faith in the benefits of the vaccines overruled any evidence to the contrary. ("Damn the torpedoes, full speed ahead!") As a result, it now appears that SV40 not only may cause cancer in humans, there is evidence for human to human transmission.

There are also those who link vaccine contaminated with monkey virus to the AIDS crisis. I am not knowledgeable about this, however.

Regardless, vaccine contamination is a huge issue, in my opinion. And one not easily resolved.

[Jack]

In my opinion this is a bunch of hand-waving by the FDA to show how tough they are and what a good job they are doing. If you looked at the 49, I'd bet you find them to be essentially silly (with the exception of the adverse event reporting failures). In fact, when it comes to manfacturing safety, the FDA goes to absurd lengths (in my opinion at the bidding of big pharms in order to make manufacturing so expensive no one but big pharms can do it). When you look at the number of the vials being produced the rate of contamination is very low and I would venture is a good as it could possibly be. Remember, contaminated vials mean big time money loss, so it is in the companies best interest to run a well controlled facility and have safety (from that point of view) as their top priority.

But there are two sides to safety, that is what is being forgotten. A product can be pure, and exactly what it claims to be and the FDA and big pharma actually do a really good job at that. That doesn't make it "safe" for the entire public. That is where the FDA is dropping the ball. 49 mostly nit-picky violations don't matter. I've seen 119 observations given in an audit before and without a single one of them being important or having any impact on released product safety. Just an auditor in a bad mood.

[Theresa]

Sandy and Ray,

I agree that the whole vaccine system is a problem, not just the toxins or the current CDC schedule. After much research, it seems clear to me that vaccines cause diseases to get stronger (expressed very well in Anne's earlier post about "Ma Nature doing pushups in the parking lot"). There is also the issue of making an immune system weak by not allowing it to experience and fight off diseases. For hundreds of reasons, I find our immunization program to be highly suspect.

However, I respectfully (and I do mean respectfully) disagree with you on one point. Ray, you said that because you believe that no vaccine is safem, you will stay home from the "Green Our Vaccines" rally. I understand your line of thinking (at least, I think I do), but I believe in the value of incremental change. I don't believe it is possible in the current political environment (by which I mean the two-party system in which both parties receive scads of money from Big Pharma and other interests) to get rid of the federal and state vaccine mandates. Assuming that this is true (that we can't get rid of all vaccines overnight), I believe it is worth our time and effort to clean them up and change the schedule in order to protect at least some children, and to raise awareness of the vaccine issues among the general population (who have NO IDEA that there is anything wrong, including aluminum and mercury).

By way of comparison... I am very strongly anti-abortion, and I believe it is always wrong. (Let's just accept this so I can make my comparison ... I am sure that many here disagree with me, but substitute another issue if you like, to help make the point.) Although I would love to see abortion completely outlawed tomorrow, I support legislation like 24-hour waiting periods because such legislation might save some unborn children, although obviously not all. If we can save some children from some health problems by removing mercury and getting rid of the mandatory Hep B vaccine at birth, then we've done a good thing. Then we can continue to fight about the larger issue of vaccines.

Just my thoughts, of course, and I am sick to my stomach at what Merck et al have been able to get our federal and state governments to mandate through lobbying $ and PAC contributions, despite all the evidence (like the items that Sandy has been posting for years) to the contrary.

[John Stone]

Ray, Sandy

An interesting case is the Cochrane Review of MMR (2005). Underneath the media spin and the institutional pieties, they quietly fail to endorse any of the science. The trawl through 5,000 associated studies boils down to 31, but even these as examined on by one turn out to be duds. In fact not only are the safety studies declared to be "largely inadequate", the effectiveness studies fall into the same category. There is - if you look at the small print of Cochrane on MMR (2005) - no science supporting the policy, and it also warns that this is true of other vaccines.

http://www.cochrane.org/reviews/en/ab004407.html

If that is the science, then we have to ask a further question about the institutions. If you have 5,000 studies none of which validate the safety and effectiveness of the product, the question arises: why would it be so hard to find such studies if the products were indeed effective and safe?

I am sure your guess is as good as mine.

Best,

John

[Sandy Gottstein]

Ray,

I agree with you completely about your concerns with vaccines in general. Given that virtually everything we know about the alleged safety of vaccines was either paid for directly, or otherwise influenced, by the vaccine manufacturers, there is nothing we can believe about claims of their safety. But there is plenty of evidence against them and I have written repeatedly about it, as have others.

I worry too about the Green Our Vaccines rally, although I appreciate the effort and that any improvements possible should be made. I do not believe however that there can ever be an entirely safe vaccine, at least for all. But to whatever extent they can be made safer, as long as there are those who choose to use them, I'm all for it. (See the mission statement of Vaccination News - http://www.vaccinationnews.com/mission_statement.htm ). Until and unless we are truly free to choose, however, particularly given the vaccine manufacturers' government-protected liability, I see no reason why they would care one way or the other whether or not vaccines are safer or safe. In fact, a case could be made that they actually have an incentive to keep them unsafe, given that unsafe vaccines, if they don't kill you outright, create new health problems that their drugs can be promoted as solving. (See "Scandals: The Perfect Business Plan" - http://www.vaccinationnews.com/Scandals/2005/Dec_23/Scandal75.htm .)

It is entirely possible, in fact, that were properly designed studies conducted, few, if any, would choose to vaccinate. That may well be what they fear.

My fear is, however, as I similarly wrote in "Is Changing the Vaccine Schedule Enough?" (http://www.vaccinationnews.com/Scandals/2008/Apr_11_08/Scandal89.htm ) that those whose injuries cannot be traced to the ingredients or makeup of the vaccines, but whose injuries instead are a result of something inherent in the vaccine process itself, will continue being ignored, abandoned on the dust heap of history. If instead of using any success in cleaning up vaccines as a springboard to help those whose problems are not addressed by doing so, those who were vaccine-injured for other reasons are left behind, I will be utterly disheartened.

Finally, I hope I don't have too many links.

[Cindy Stotlen]

Sandy, thanks for posting the Scandals columns, and for all the years of dedication. The Philadelphia Inquirer isn't the only newspaper/journalist, who requested documents through FOIA. Ed Silverman also did on the Wyeth Prevnar vaccine. Doesn't seem like much came out of this either. Shouldn't surprise anyone the CDC doesn't know, or care. Why would they? Children's deaths after vaccines are classified as SIDS.

http://users.adelphia.net/~cdc/Doctors%20decry%20lack%20of%20Wyeth%20vaccine%20Prevnar%20changed.pdf

[Raymond Gallup]

This article supports what I'm saying about vaccines in general being unsafe. There has never been an independent, long-term safety studies done on any vaccine. This is the third time they have been caught so it makes one wonder how many times did they do this and not get caught?

Over the years I have supported Andrew Wakefield and Vijendra Singh research regarding the MMR vaccine and autoimmunity and will continue until the day I die. It put Eric over the edge and other children with autism (with elevated measles antibodies, testing positive for myelin basic protein antibodies and measles in the gut and spinal fluid). Dr. Singh found in one study that parents implicated the MMR and DPT. I believe strongly that no one vaccine or ingredient like thimerosal is THE culprit for the autism epidemic. Also, I know of a parent who was told mercury free vaccines were safe, their children with autism were administered the mercury free vaccines and almost died.

Of course with the recent Green Vaccine rally discussion on the blog and Internet, people like me should be isolated and called lunatics and extremists. With this feedback from parents/organizations why would anyone who disagrees about the concept of Green Vaccines want to go to these rallies? And so I and others who believe strongly that no vaccine is safe will stay home. I have no reservations about that.

The one thing I can say that in 2003, it was "thimerosal free vaccines are safe". Now in 2008 it is "Green Vaccines". What will it be in 5 years hence from now....10 years....20 years, etc.????

I feel this strategy is doomed to fail. You can't go back in the future and say....gee, I was wrong....all vaccines are unsafe. They (parents/organizations pushing the "Green Vaccine" agenda) say it won't fly now. It won't fly years from now unless organizations come up with the independent science to prove it. Also, unless the Federal Courts decide in favor of most of the 4,800+ plaintiffs (I hope and pray it is all of them) involved in the Vaccine/Autism cases this thing will drag on forever.


By trying to chip away at the medical mainstream over decades and not coming out and saying vaccines are unsafe, period is the wrong strategy. Time will tell if I'm right or wrong.

I know I'm right.....unfortunately for those that are pursuing the wrong strategy.

Raymond Gallup

[Sandy Gottstein]

Here are a couple of lists of references on vaccine contamination that I prepared for my colums:

Contamination of cell cultures:
http://www.vaccinationnews.com/Scandals/2004/Jan_2/contamination_of_cell_cultures.htm

Problems with detection:
http://www.vaccinationnews.com/Scandals/2004/Jan_2/re_detection_of_contamination.htm

[Teresa Conrick]

"Federal inspectors documented unwanted "fibers" on the stoppers of vaccine vials at Merck & Co. Inc.'s vast vaccine plant in Montgomery County."

Fibers....where have we heard of that lately?

http://en.wikipedia.org/wiki/Morgellons

[Anne Dachel]

My favorite line--
John T. McCubbins, head of Merck's Global Vaccine Manufacturing and West Point Operations: "Nobody's perfect."

Anne Dachel
Media editor

[Monica]

From the AP-

"Meanwhile, a CDC spokesman said Thursday that the agency is not aware of problems with vaccines at the plant and so is not taking action."

http://ap.google.com/article/ALeqM5jmBNFbESVxxYmOpNlGUcqQeib57wD908GKQ01

The agency is not aware? Do they not read the news? Not taking action? I am so disgusted with and disappointed in our nation.

[Sandy Gottstein]

Many years ago a reporter, I think she was from NBC, but I'm not sure, contacted me about vaccine contamination. Said she was going to do something on it, so I sent her a box of journal articles concerning contamination of vaccines. Never heard from her again.

Here's some of what I have written about it in the past:

Scandals: On "mad cows" and sick monkeys: From the people who brought you SV40 in vaccines.... (http://www.vaccinationnews.com/Scandals/2004/Jan_2/Scandal69.htm )

Scandals: The Institute of Medicine Review of SV40 Contamination of Polio Vaccine and Cancer (http://www.vaccinationnews.com/Scandals/oct_25_02/Scandal39.htm )

[Flipper]

Business as usual for Meurck it seems:

April 18, 2008
Merck Caught in Massive Scientific Fraud as In-House Authors were Disguised as Independent Scientists
http://www.naturalnews.com/023052.html

[Tanners Dad]

Sammie Young, a retired FDA deputy director, inspected the West Point plant early in his career and for many years oversaw vaccine-plant inspections for the entire agency.

"I am concerned about the adverse-event reporting system," Young said. "It looks like the people didn't know when they were supposed to report. I find that hard to believe."

John T. McCubbins, who heads Merck's Global Vaccine Manufacturing and West Point Operations
said he feared the FDA report could create unwarranted "panic" about the firm's vaccines.
The plant would make changes, he said, "where we believe that the agency may have a point and often they do. Nobody's perfect”

Does this make you feel safe. Who is watching the hen house? The “Panic” will come when the Vaccine makers have to pay for the damage done to our children.

[Monica]

FDA's report on Merck's vaccine manufacturing released through Freedom of Information Act. FDA cited 49 areas of concern.

This is the FDA's report-
http://media.philly.com/documents/FDA+Inspection.pdf

the main question I have, is item #37, "subsequent expiry extensions"

Does this mean, they can extend the expiration date? From Nov 2004 until May 2008? Anyone have any idea what this means?

[Lying Merck]

"John T. McCubbins, who heads Merck's Global Vaccine Manufacturing and West Point Operations, disputed that assessment. He maintained that the division's employment had kept pace with vaccine production. He stressed that no contamination was found in finished vaccines and that Merck was addressing all the problems."

Didn't they say that they found fibers in the vaccine vials? Isn't that contamination (the word has been around since the 15th century and I think the meaning of it has not changed in all this time!)? Disputing "liar liar pants on fire."

And why did they begin to address problems after the FDA found the 49 problems? And if this is a premier plant I shudder to think what the rest must be like. This thing is going into peoples veins. This is unacceptable. A big hue and cry needs to made about this. For starters the FDA needs to go into every vaccine plant out there. I would also like every major media outlet to pick up this story and run with it.

[Jeanne]

If I may quote Mark Twain.... Denial ain't just a river in Egypt.