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Author Topic: FDA to discuss use of canine kidney cells in production of live flu vaccine  (Read 271 times)
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Poco
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« on: September 03, 2008, 05:31:10 PM »

http://www.fda.gov:80/cber/advisory/vrbp/vrbp0908.htm
"In open session the Committee will be briefed on the Office of Vaccine’s Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER) response to OVRR Office Site Visit Review Report that was presented and approved by this committee on January 25, 2007. The Committee will also hear presentations and hold discussion on the use of Madin-Darby canine kidney (MDCK) Cells for manufacture of live attenuated Influenza Virus Vaccines."
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JJ
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« Reply #1 on: September 03, 2008, 06:36:22 PM »

Doesn't say on the link how they plan to obtain these cells from canine kidneys. And turn them into flue vaccine? Will these animals be fed only human grade, chemical free, no preservative, no melamine, no cynauric acid, no phophoric acid, no glycols of any kind, NO GMO'D of any kind, no hydrogenated oils, fats etc, purified water that doesn't contain whatever may come thru the tap water so their blood is healthy from the get go? What person will step forward to volunteer for a vaccine when so much pet food is suspect IMO and who knows what all is in it thats not being revealed on the labels and they might use these dogs kidney cells that have eaten like this? Will these animals be tested for cancer, liver disease, pancreatic problems, kidney problems, thyroid issues, heart problems? Will the animals that may have medical problems cells be used? What will the cells do inside of a humans body to their cells? Why do they need kidney cells from canines? What is special about these particular cells?

Some people might have good intentions but the time spent on this - why?



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DMS
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« Reply #2 on: September 03, 2008, 06:37:37 PM »

Klondike, I think this may be valueable information to some who want to keep up with what is in the flu vaccine, especially considering this link:

http://www.dddmag.com/cell-culture-breaks-some-eggs.aspx

Cell culture is also free of certain risks associated with egg-based production, including shortages due to contamination by poultry-based diseases (including, potentially, H5N1 itself). For these reasons, cell culture has the potential for making commercial, on-demand vaccine manufacturing possible.

But before the promise can be achieved, several obstacles must be overcome. Cell culture-based vaccines are often derived from mammalian cells and run the safety risk of passing viruses or other contaminants into those immunized. Some cell lines are based on African green monkey (Vero) kidney cells and human retinal cells. Others come from Madin-Darby Canine Kidney epithelial cell lines (MDCK), derived from a healthy female cocker spaniel in 1958 and widely used in vaccine research. "While some lines of MDCK cells are not tumorigenic, others are highly tumorigenic," state briefing materials prepared by the Food and Drug Administration (FDA).

The FDA appears comfortable that potential risks associated with tumorigenic cell substrates can be mitigated. "Although there is a perception that highly tumorigenic cells may carry greater risks than less tumorigenic cells, we are proposing that such risks can be mitigated by careful testing of the cells, validation of the production process for its capacity to remove adventitious agents, and limitation of residual DNA in the final product," the FDA said in a statement.
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Hopefully that is true, because this:

http://www.globalhealingcenter.com/forum/viewtopic.php?p=1684
It is "not possible to determine whether the use of a cell substrate that is strongly tumorigenic poses more of a risk than one that is weakly tumorigenic," FDA said.

Although, there is not citation for that last comment.  It can probably be researched.
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Mandycat
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« Reply #3 on: September 03, 2008, 10:02:15 PM »

MDCK cells are merely virus tissue culture.  This line of cells has been around since 1958 and have had many uses.  Here is a site that describes the MDCK cells.  I don't think that there is going to be any obtaining kidney cells from any dogs as this is a type of culture medium already in use in laboratories, as I understand it.  Maybe someone on here that has more experience in microbiology can give a better layman's explanation.

     http://www.microscopyu.com/galleries/fluorescence/cells/mdck/mdck.html
« Last Edit: September 03, 2008, 10:06:48 PM by Mandycat » Logged
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« Reply #4 on: September 03, 2008, 10:14:25 PM »

Klondike, I think this may be valueable information to some who want to keep up with what is in the flu vaccine, especially considering this link:

http://www.dddmag.com/cell-culture-breaks-some-eggs.aspx

Cell culture is also free of certain risks associated with egg-based production, including shortages due to contamination by poultry-based diseases (including, potentially, H5N1 itself). For these reasons, cell culture has the potential for making commercial, on-demand vaccine manufacturing possible.

But before the promise can be achieved, several obstacles must be overcome. Cell culture-based vaccines are often derived from mammalian cells and run the safety risk of passing viruses or other contaminants into those immunized. Some cell lines are based on African green monkey (Vero) kidney cells and human retinal cells. Others come from Madin-Darby Canine Kidney epithelial cell lines (MDCK), derived from a healthy female cocker spaniel in 1958 and widely used in vaccine research. "While some lines of MDCK cells are not tumorigenic, others are highly tumorigenic," state briefing materials prepared by the Food and Drug Administration (FDA).

The FDA appears comfortable that potential risks associated with tumorigenic cell substrates can be mitigated. "Although there is a perception that highly tumorigenic cells may carry greater risks than less tumorigenic cells, we are proposing that such risks can be mitigated by careful testing of the cells, validation of the production process for its capacity to remove adventitious agents, and limitation of residual DNA in the final product," the FDA said in a statement.
___________________________
Hopefully that is true, because this:

http://www.globalhealingcenter.com/forum/viewtopic.php?p=1684
It is "not possible to determine whether the use of a cell substrate that is strongly tumorigenic poses more of a risk than one that is weakly tumorigenic," FDA said.

Although, there is not citation for that last comment.  It can probably be researched.

Some cells are highly tumor producing? So create a vaccine and quite possibly give the person the beginning cancer cell into their bodies? WTF - no wonder there is not a cure for cancer - look at how they keep giving it to people by creating a vessel to introduce it into the body with. What with chest xrays, rays from the sun creating its own amount of rads, dental xrays, female check up xrays, broken bone xrays, cat scans, etc. Cancer for everyone-come one come all. So along with your flu shot we have extra roll of the dice bonus for you - cancer cells - no extra charge.
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Poco
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« Reply #5 on: September 04, 2008, 12:39:48 AM »

My main concern was contamination when I read about this.  The CDC has now admitted that a couple of studies show an 'association' between a monkey derived viral contaminant in the polio vaccine and brain cancers that developed in children exposed in the womb to the virus.  It has taken many decades for this to come out in the open. 

http://www.cdc.gov/vaccinesafety/concerns/archive/polio_and_cancer.htm#13
Have research studies looked at the risk of cancer in children whose mothers received SV40-contaminated polio vaccine?
Yes, two studies concerning maternal vaccination with SV40-contaminated vaccines and risk of cancer in offspring have been conducted. Each study reported an association.

Heinonen et al. (1973) reported a higher incidence of neural malignancies in children born to mothers who received inactivated poliovirus during pregnancy. The prospective study of over 50,000 women who were pregnant between 1959–1965 identified 24 malignancies in their children during the first 4 years of life. The rate of malignancy was about two-fold greater in children born to mothers immunized during pregnancy when compared with children born to unimmunized mothers or mothers who received influenza or OPV vaccines. Neural tumors accounted for most of the difference.


Farwell et al. (1979) found that of 15 cases of medulloblastoma in children born in Connecticut between 1956–1962, 10 were born to mothers exposed to SV40 contaminated polio vaccine while 5 were born to mothers unexposed. Interpretation of these results, however, is hampered by the low response rates and uncertain accuracy of vaccination histories by obstetricians (Strickler et al., 1998).


1997:
http://www.fda.gov/cber/minutes/sv40012797-1.htm
DIRECTOR ZOON: On behalf of sponsor's agencies today, which include the National Institute of Child Health and Human Development at NIH, the Division of Cancer Epidemiology and Genetics at NCINIH, the National Center for Infectious Diseases and National Immunization Programs at CDC, the National Vaccine Program Office, and the Center for Biologics, Evaluation, and Research of FDA, I'd like to welcome you to this workshop on SV40.

We, the sponsors of this workshop are pleased that so many of the national and international scientific community have come to discuss this very important topic. The workshop was prompted by recent reports demonstrating the presence of SV40 viral sequences in tissue, including certain rare, human tumors, and the fact that SV40 was an unsuspected contaminant in early polio and adenovirus vaccines.


Some general contamination issues:
http://www.fda.gov/cber/minutes/infcagnt1025.pdf
WORKSHOP ON STANDARDS FOR INACTIVATION AND CLEARANCE
OF INFECTIOUS AGENTS IN THE MANUFACTURE OF PLASMA
DERIVATIVES FROM NON-HUMAN SOURCE MATERIALS
FOR HUMAN INJECTABLE USE
+ + + + +
MONDAY
OCTOBER 25, 1999

the realization that there are contaminants in not
just animal, but human biologic materials which don't
cause acute and obvious disease
, so you -- we tend to
think we have quite a good warning system because if
something is wrong we will know about it. But as the
situation with retroviruses indicates, there can be
real problems in source materials that may have an
outcome that is only apparent many years later and
may not necessarily be easy to tie to the source material
.



That way, no liability for the vaccine maker or the government.  The 'herd' won't help you or thank you for your service to mankind.  They will leave you in the dust.  So make sure you understand the risks involved.  Is there a reasonable tradeoff for taking that risk to you and your family?  The fact that this is a live vaccine is something to be concerned about, too.  They can be infectious, so is the potential exposure of pregnant women really being considered?  Remember it takes decades to sort these things out.

http://www.newscientist.com/article.ns?id=dn6116
Vaccine scandal revives cancer fear
19:00 07 July 2004

"Many millions more people than previously thought might have been given polio vaccine contaminated with a monkey virus linked to cancer.

It has been known since 1960 that early doses of polio vaccine were widely contaminated with simian virus 40, or SV40, which infects macaque monkeys. Tens of millions of people in the US and an unknown number in other countries, including the UK, Australia and the former Soviet Union, may have been exposed prior to 1963.

The contamination occurred because the kidney cells the vaccine virus was grown in came from monkeys infected with SV40. Health officials say the problem was eliminated after 1963.

Now Michele Carbone of Loyola University Medical Center in Chicago has announced results that suggest the Soviet polio vaccine was contaminated after 1963, possibly until the early 1980s. "Is there infectious virus? The short answer is, yes," Carbone told the Vaccine Cell Substrate Conference 2004 in Rockville, Maryland, last week....



This never had to happen.  Sweden stopped distributing the vaccine as soon as they knew about the contamination.  They monitor for the virus and last time I searched Medline, they were clean.  They had and hopefully still have a genuine public health service, rather than a sham.

We still don't know what is going on with the vaccine stock and cell lines here:

http://www.sv40foundation.org/Demanding-CI.html
When Alexander was born on June 7th, 1996, I had his cord blood saved and stored by a private laboratory.  The cord blood was the blood shared by Alexander and myself at the time of Alexander's birth.  We had this blood tested for SV40.  This marked the very first time the cord blood of a child with an SV40 positive brain tumor would be tested for SV40.  To the astonishment of the scientists it was negative for SV40.  This suggested that at the time Alexander was born he had not been exposed to SV40.
It is known that SV40 can be spread through contaminated blood so my husband and myself underwent a battery of tests from 2000 to 2001.  Using a variety of sophisticated DNA tests to isolate the genetic fingerprint of the SV40 virus including Polymerase Chain Reaction (PCR), the scientists checked blood, urine and semen multiple times looking for any trace of SV40 (even antibodies).  The scientists were once again surprised.  Despite the repeated tests by leading SV40 laboratories both in the United States and Europe, we had absolutely no trace of SV40.
The scientists concluded that Alexander did not get SV40 from his parents, nor did he give SV40 to us.



Not to alarm people but I would keep an eye on this especially if you have children or are planning on doing so.

CDC admits 2 studies link the polio vaccine to childhood brain cancers.
http://www.cdc.gov/vaccinesafety/concerns/archive/polio_and_cancer.htm#13

It could happen again.

(And just in case someone got the impression that dog kidneys are not still being 'harvested' for vaccine research since an older cell line is being used in this case - that is not true:
http://www.ajtmh.org/cgi/content/full/69/6_suppl/5
Also, many animals suffer greatly in testing vaccines, including cats and dogs.)
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