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Poco
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« on: May 04, 2008, 10:41:59 PM » |
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This looks very serious! http://www.fda.gov/foi/warning_letters/s6756c.htm
April 28, 2008
WARNING LETTER OEWL-08-02
EXPRESS MAIL
Richard T. Clark
President and Chief Executive Officer
Merck and Company, Inc.
770 Sumneytown Pike
West Point, Pennsylvania 19486-004
Dear Mr. Clark:
The Food and Drug Administration (FDA) conducted an inspection of Merck and Company, Inc., West Point, Pennsylvania, between November 26, 2007, and January 17, 2008. During the inspection, the FDA investigators documented significant deviations from current good manufacturing practice (CGMP) in the manufacture of licensed biological vaccine products, bulk drug substances, and drug components. These products include Liquid PedvaxHIB®, RECOMBIVAX HB®, ProQuad®, Gardasil®, VAQTA®, and COMVAX®. These deviations from CGMP include non-compliance with Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the requirements of your biologics license application approved under Section 351 of the Public Health Service Act (PHS Act), and Title 21, Code of Federal Regulations (21 CFR) Parts 210 and 211.
At the close of the inspection, the FDA investigators issued a Form FDA 483, Inspectional Observations, which described a number of significant objectionable conditions relating to your firm’s compliance with CGMP. Significant deviations observed during the inspection include, but are not limited to, the following:.....
...To facilitate your remediation efforts we request a meeting with you and other senior management at Merck to further discuss the issues cited in this letter and your proposed responses to address them. Given the potential contributions of safe, pure, and potent vaccines to the public health, we encourage frequent interactions between your technical staff and FDA in an effort to help Merck move forward with corrective actions as rapidly as possible.
Very long and serious list of concerns. Knowing what harm tainted vaccines can cause, I really hope this is a sign that the FDA is finally putting public health ahead of drug company profits. Maybe all the activist parent groups and the efforts of their brave scientist, politician and journalist supporters, (such as Robert Kennedy, Jr.) are finally paying off? |
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kaffe
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« Reply #1 on: May 04, 2008, 11:02:18 PM » |
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oh boy!  This is scary!!! Good find, Klondike. I hope the doctors - especially those is pediatrics know about this! |
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DMS
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« Reply #2 on: May 05, 2008, 10:31:33 AM » |
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All of those redacted words can not be considered proprietary secrets. What is up with that?
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None are more hopelessly enslaved than those who falsely believe they are free.
-Johann Wolfgang von Goethe
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trudy1
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« Reply #3 on: May 05, 2008, 10:31:57 AM » |
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What is each drug? Does anyone know? I know a couple, but that's all. thanks.
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Poco
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« Reply #4 on: May 05, 2008, 08:11:03 PM » |
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What is each drug? Does anyone know? I know a couple, but that's all. thanks.
I think all the ones with 'vax' in the name are vaccines, along with Gardasil. I Googled VAQTA http://www.merckvaccines.com/vaccines/hepa/VAQTA is the first hepatitis A vaccine approved
for children as young as 12 months of age.
 Happy Birthday from Merck! Very sad. Is that wise and good public health for little one yr olds? I heard how many shots are recommended for toddlers now and it just seems like so very many. Can their developing brains really tolerate this? Some people are worried about the amount of aluminum in childhood vaccines, let alone contamination risks. http://www.mothering.com/articles/growing_child/vaccines/aluminum-new-thimerosal.html |
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Donna
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« Reply #5 on: May 17, 2008, 10:51:25 AM » |
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Has anyone had a personal experience with the HPV virus vaccine, or knows anyone who has?
I ask because I am trying to talk my daughter out of getting this three step vaccination - similar to the HIB vaccine for children, or so, I believe.
Yes, she knows my concerns re "repercussions by vaccine" as this has taken place in young women, but she insists upon receiving the shots for HPV, which prevents a host of nasty, ugly transmittal diseases, along with cervical cancer. Her doctor knows of my concerns, and her doctor just laughed when my daughter related them, saying, "Tell your mother, she cannot believe everything she reads."
Well now I have some proof re Merck and HPV vaccine from this post! Surely, if the FDA has worry, then the doctor's should, too!
Thanks K, for this, I missed it entirely before!
Sincerely,
Donna
average citizen for justice and equality
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« Last Edit: May 17, 2008, 10:53:25 AM by Donna »
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Disclaimer: Opinions, thoughts & premises are my own, except links & quotes.
"Your task is not to seek for love, but merely to seek and find all the barriers within yourself that you have built against it." Rumi
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DMS
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« Reply #6 on: May 17, 2008, 12:17:39 PM » |
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Donna, somewhere on Itchmo, Gardasil was discussed. http://itchmoforums.com/off-topic/doctoring-the-news-t1259.0.html;msg16446#msg16446Some previously healthy girls have died from it. It's rare, but why take the risk. PM Klondike, if she doesn't see your post. She may have found even more info. I have 2 teenagers and am not letting them get it. The nurses come to the school with it now and wanted permission to vaccinate!!! Huh! No way. If they choose to get it when they are older, that is their choice. I will not agree to it for them. Don't believe everything your doctor or drug rep tells you. They've been wrong before. |
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« Last Edit: May 17, 2008, 01:14:07 PM by DMS »
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None are more hopelessly enslaved than those who falsely believe they are free.
-Johann Wolfgang von Goethe
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trudy1
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« Reply #7 on: May 17, 2008, 12:44:30 PM » |
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Donna, If your daughter gets Her Exams every year, She will be fine without the vaccine. My daughter wants it for My grandaughter, but i don't think it's worth it.
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Poco
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« Reply #8 on: May 17, 2008, 01:42:08 PM » |
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Looks like you could at least reduce risk by not administering with other vaccines and laying down when you get it. I think HPV is the only STD it may prevent, though. http://www.aapsonline.org/nod/newsofday458.php"An analysis of VAERS data by the National Vaccine Information Center (NVIC) concludes that the risk of serious adverse reactions such as GBS is increased by concomitant administration of other vaccines. In patients who made a report to VAERS, the risk of GBS is more than 10 times greater for Gardasil given with Menactra compared to Gardasil given alone (P<.0001). A causal relationship with vaccine administration has not been proved. The background incidence of GBS in persons in the second decade of life is 1-2/100,000.
According to an NVIC press release, one of the patients who reported a reaction to VAERS was an 18-year-old athlete who ran 6 miles/day before receiving Gardasil, Menactra, and Varivax on the same day. She did not need a ventilator but was hospitalized for 22 days with weakness of all limbs. Now receiving physical therapy, she hopes at least to be able to play the guitar, draw, and smile again.
The second most commonly reported adverse event is syncope, with 239 reports. Sometimes this has resulted in serious injury, including fractures and subdural hematomas. It is suggested that vaccines be administered with the patient supine and be followed with at least 10 minutes of observation. Syncope has, however, occurred after a longer delay.
Gardasil is now involved in 15–20 percent of all VAERS reports that are filed. "
The CDC still maintains that it is safe: http://www.cdc.gov/vaccinesafety/vaers/gardasil.htmBut I can't find data anymore in the VAERS database. There is a generic 'HPV' vaccine listed where the name/manufacturer was not put in, but that is not the bulk of the Gardasil data that used to be there, unless I am missing it.Select HPV4 from vaccine list on right of page. http://www.medalerts.org/vaersdb/index.html |
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« Last Edit: May 17, 2008, 01:52:55 PM by Klondike »
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Poco
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« Reply #9 on: May 17, 2008, 01:51:39 PM » |
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Donna
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« Reply #10 on: May 18, 2008, 05:35:12 AM » |
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Thanks EVERYONE, you have been most helpful!
I did show my daughter the warning letter from the FDA to Merck, but all she said was, so what, they didn't do anything!
Though I do not agree, I have to understand her side: she wants to go ahead with this and it is her body (yes, she is of age to decide).
I have kept this post, just in case anything happens to her, as the doctor warned her, she must stay for an additional fifteen minutes for possible "side effects" ... you know, those ones that have already been reported!
A folly in my eyes!
Sincerely,
Donna
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Disclaimer: Opinions, thoughts & premises are my own, except links & quotes.
"Your task is not to seek for love, but merely to seek and find all the barriers within yourself that you have built against it." Rumi
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DMS
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« Reply #11 on: May 18, 2008, 07:38:47 AM » |
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Did you show her all of the adverse events?
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None are more hopelessly enslaved than those who falsely believe they are free.
-Johann Wolfgang von Goethe
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