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India Suspends Gardasil Program After Four Deaths and Complications in 120 Girls

Safety first From (DNA India HERE)

Delhi: The Indian Council of Medical Research (ICMR) has told Andhra Pradesh and Gujarat to immediately suspend the cervical cancer control vaccination programme for girls. The programme is part of a two-year study to look into the utility of a vaccine in public health programmes and acceptability of Gardasil, the human papillomavirus (HPV) vaccine made by Merck. Gardasil, available in medical stores across the country, is marketed in India by MSD Pharmaceuticals Pvt Ltd.

The programme was marred by controversy after four deaths and complications among 120 girls were reported after vaccination. The girls complained of stomach disorders, epilepsy, headaches and early menarche. Women activists fear the vaccine may impact the mental health of girls who have shown no signs of distress so far.

Health ministry sources said the vaccination programme is being conducted by Gardasil, jointly with PATH, a Seattle-based NGO, ICMR and the two state governments. About 32,000 girls, aged 10-14, were to be tested in the study.

ICMR chief Dr VM Katoch clarified ICMR was only a technical partner, with an advisory role, in the project. But Katoch said they were checking out who was at fault.

Questioning the study, CPM leader Brinda Karat said: “How has the government embarked on the study of giving three injections to the girls when it is also planning a massive multi-centric dose determination study to see if two doses will suffice?”

For a drug to be administered to children, Karat said, it has to go through stages of clinical trial, including phase 3 adult clinical trials. With Gardasil, only one trial has been carried out with a small sample of 110 girls, which has followed up with them for a month after completion of vaccination and that too only to look at the immune response post-vaccination, Karat said. The vaccine has also been approved for adult women aged 27, Karat said, without any trials on them.

Karat also alleged scientific logic and ethical guidelines have been violated at each step during drug and vaccine trials.

Comments

Garbo

"I use to think the depopulationist agenda was just some wild, fringe conspiracy theory...now sometimes I wonder."

So relieved it's not just me. Let's not forget our old friend polysorbate-80, found in Gardasil.

http://www.whale.to/v/tween_80.html

And then there's that study of GM corn that found it lowered fertility...but was later withdrawn (sound familiar?).

http://www.gmo-compass.org/eng/news/499.docu.html

Remember, tin foil is the new black.

sarah

Janice said: "fear there is a bigger agenda in place to reduce the population, and that this vaccine, as well as many other questionable vaccines, is the vehicle to create infertility or otherwise reduce the population of the planet."

I use to think the depopulationist agenda was just some wild, fringe conspiracy theory...now sometimes I wonder. We live in strange times. Up is down, black is white
good is bad.

Like Alice going through the looking glass, once you go to the other side you see how truly distorted things are.

Janet Keith

I have read of too many adverse reactions as well as deaths from this scary vaccine. It makes no sense to me to give such a vaccine to young girls just as their bodies are developing into young women. I fear there is a bigger agenda in place to reduce the population, and that this vaccine, as well as many other questionable vaccines, is the vehicle to create infertility or otherwise reduce the population of the planet. It is curious to me how our country is supposed to be so superior in our development and discoveries, and yet our infant mortality rate is far greater than many countries less developed than we are. Many people in Africa have caught on that the vaccines are causing fewer babies to be born. Interestingly enough, if we wanted to really improve the health of the African people, clean water would seem to be the best way to decrease disease....however, we have chosen to send billions of dollars of vaccines to them to be given to children who are malnourished and whose immune systems are already compromised. I am guessing clean water would cost far less...but the intended results (depopulation) would not be accomplished. I suppose now India is now the target of this agenda.

Not an MD

We don't know if the Gardasil and Cervarix vaccines being tested in India are identical to those in other countries if it is true that they are testing the efficacy of only two doses versus three in India. Is the antigen content used in the two dose testing the same as a regular Gardasil shot, or has it been altered to add more antigen or more adjuvant? Are they doing this testing to see if the cost of the vaccine can be reduced to make it more affordable in India? Why is this testing being done now, in India? We do not know the answer to these questions as no article provides the answers. If dosage is indeed being tested as the articles from India indicate, it would have to be a clinical trial, would it not?

Benedetta

Cherry:
what are the people saying around you over there in India?

MinorityView

quote from the link provided by not an MD:
The HPV Vaccines: Evidence for Impact project is meant to generate evidence to help policymakers
and planners worldwide make informed decisions regarding regional and national vaccine
introduction efforts and international financing plans. It is not a clinical trial of a new vaccine.
The vaccines being used are already licensed in more than 100 countries, including India.
This report shares findings from the formative research in India, which was carried out by
PATH and the National AIDS Research Institute (NARI) of the Indian Council for Medical
Research (ICMR) in two states—Andhra Pradesh and Gujarat—to explore approaches to
vaccine introduction. The results from India provide insight into the complexities of vaccine
introduction in a country with a population of more than one billion people. In general, we found
that policymakers, health care providers, parents, and adolescents in both states would accept
vaccination against cancer of the cervix, as long as it is safe, effective, affordable, and accessible.

Not an MD

Garbo is completely correct. Want to barf? Read the following:

http://screening.iarc.fr/doc/PATH_FRTS_India.pdf

I hope the link works.

jen

actually we don't know if only 120 girls were in the vaccine program or if the number was much greater and 120 had bad side effects including death. Still, 4 deaths and epilepsy among even thousands is terrible. What would make a parent be willing to chance that their child could be one of 4 in a several thousand? No doubt they'll blame it on the pill...

Garbo

Spacekitty, wonder not what Bill Gates thinks. According to this rather more detailed article, the Bill & Melinda Gates Funded it.

http://beta.thehindu.com/news/national/article391111.ece

It seems that it was billed as a "demonstration project" by the non-governmental organization PATH, which was conducting the project for MERCK. But it wasn't actually a demonstration, it was a clinical trial. Turns out conducting clinical trials on children before they're done on adults is ILLEGAL in India.

So I think the bigger question is, what does Bill Gates' lawyer think about all this? And why is the Gates Foundation funding clinical trials conducted by an NGO pass-through for Merck? Somebody's got some splainin to do.

AnaB

I feel so sad. I know of the guilt these moms must be feeling right now for allowing their girls to get this shot. It is the same guilt we all feel every day. The guilt is of course misplaced: it is not our fault, but knowing this intellectually doesn't stop the feeling.

Signs of distress

"The programme was marred by controversy after four deaths and complications among 120 girls were reported after vaccination. The girls complained of stomach disorders, epilepsy, headaches and early menarche. Women activists fear the vaccine may impact the mental health of girls who have shown no signs of distress so far."

It is a good thing that Indian women activists can actually "think."

lisa

Only 120 girls in the study and 4 of them died? OMG! That's worse than anything I've heard before about this horrible vaccine! What's going on here? Does anyone know the real scoop?

jen

Interesting. Hopefully the ICMR will have the balls to see this to completion. Spain had problems and seemed to chalk it up to a bad batch. Spacekitty: just read Superfreakanomics and was interested in their mention of polio vaccine as a cheap, simple solution to a medical problem. Of course they didn't mention SV-40 and the "externalities" (unintended spin-off effects) of that. If vaccines play a role in autism (as I believe they do) then the whole "cheap and simple" solution thing is shot to hell. The high cost of autism far exeeds any benefit the vacc program would bring. People like Nathan Myhrvold could help with this problem if they were inclined to do so, but are they? Indeed what does Myhrvold and Bill Gates think?

Kerbob1

I wonder what the latest news from America is?

It's amazing that these vaccines are on "real" trial around the world, yet under the noses of American authorities everything is peachy keen.

Half the people working at Merck probably don't even consider the fact that they are working for what is essentially a foreign drug company.

Merck spends billions on "education".

Merck also produces an allopathic bible of sorts and assorted library materials which chronically infest the medical profession in America.

Merck's track record in America is very poor. So poor that it requires constant investigation which often leads to civil trials with lots of punitive damage awards and fraud recovery.

America gained an interest in Merck after it was won as a spoil during world war. When political pressure was applied the Berlin Wall fell and American entered a new era of assault.

http://xrl.in/50hh

If parents wonder why for example the Med waivers system is dysfunctional it might have something to do with the fact that Merck failed to pay proper rebates to Medicaid and other health care programs and paid illegal remuneration (bribery) to health care providers.

According to reports, On February 7, 2008 Merck agreed to pay more than $650 million to settle charges that it routinely over billed Medicaid for its most popular medicines.

Merck made the settlement without an admission of liability or wrongdoing. One whistle-blower received a $68 million reward.

And you wonder where this is coming from?

http://www.youtube.com/user/kerbob1#p/u/0/qzNsOSstII8

Dig for yourselves.

spacekitty

Well it is nice to know that someone in the world has common sense and self control. Too bad they don't live in America. I wonder what Bill Gates thinks.

Beth

"With Gardasil, only one trial has been carried out with a small sample of 110 girls, which has followed up with them for a month after completion of vaccination and that too only to look at the immune response post-vaccination, Karat said."

This is pretty much par for the course on all vaccines isn't it? Small sample groups in studies and the only post-vaccine studies done look at whether or not the person developed antibodies to the vaccine antigen. Lame for sure, but business as usual for vaccines, or as they are often called "the most carefully and thoroughly studied" biological products on the market.

That is yet another big, hungry lie.

JenB

It sounds to me like Merck is trying to fast-track "safety studies" at the expense of these girls, so they can try again to "mandate" this vaccine here and elsewhere. I'm feeling very queasy.

JenB

http://www.dnaindia.com/india/report_cancer-vaccine-programme-suspended-after-4-girls-die_1368681

I think they moved the story. I had to go to the above page to read the story at the source.

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