NVIC E-news"A two-year-old girl of this village, Saniya, suffers from Type I polio despite being administered more than seven doses of the new polio monovalent vaccine (MOPVI), which is made specially for the Type I poliovirus. The vaccine was introduced in mid-2005 and tom-tommed as the final step in the eradication of polio from India...... There are 15 cases of Type I polio spread across Uttar Pradesh (There are also 41 cases of Type II polio which takes the total count to 56). While there has been no reported Type I case in the endemic Moradabad, the new cases have been reported from eastern and central Uttar Pradesh; so instead of just a region, cases of wild polio are being reported from all over Uttar Pradesh now.
"Saniya's mother, Noorjahen, is furious. "She is having polio drops ever since she was four days old. She has had over a dozen doses of the polio drops. We came to know about her polio when she got a high fever. She could barely manage to stand, could not walk at all, after the fever. We took her to the local hospital where they did a stool test. We were later told that she has polio," she recounts. "There must be some thing wrong with the polio drops if even after so many doses my child has contracted polio. The government should test medicines before they are used. Pata nahin bachchoo ko kya pila rahin hain!" (Don't know what they are making my child drink), she adds.
"Head of the pediatrics department of Delhi- based St Stephen's Hospital, Jacob Puliyel, took up the matter with Lancet. In his strong-worded letter to Lancet's editor, he wrote: "We are shocked and dismayed that Lancet should have published the paper on the protective efficacy of monovalent oral Type I poliovirus...having overlooked the serious ethical issues involved." He went on to write, "What was introduced, according to this article, was a new vaccine that was five times more potent than previous vaccines, presumably also with the increased likelihood of adverse effects. No informed consent was taken, nor was the public told that the vaccine was experimental. Efforts were made to give the impression that the monovalent vaccine was not new." - Tehelka (New Delhi, India)Barbara Loe Fisher Commentary:
The wild-eyed vaccinologists are at it again. This time, World Health Organization doctors are hunting down children in India to pour a high potency live polio vaccine down their throats without telling parents it is an experimental vaccine. Using the unscientific rationale that "more is better" and with a callous disregard for human life and human rights, WHO officials replaced the tri-valent oral polio vaccine with an untested high potency monovalent Type 1 oral poliovirus vaccine without telling the public what it was doing.
Now there is more Type 1 (and Type 2) polio in India plus an unexplained higher incidence of non- polio Acute Flaccid Paralysis following widespread use of the experimental polio vaccine. Trotting out the shabby "coincidence" argument, the WHO's predictable response is "This is due to better reporting and surveillance. We know by our 50 years of experience that the polio vaccines are safe."
We have seen vaccinologists exercise unchecked power and experiment on children without the informed consent of their parents before and we will see it again. Exploitation is easy when people are carefully taught to trust and obey the orders of anyone wearing a white coat who comes to vaccinate.
The distraught mother of a little girl crippled by Type 1 polio after swallowing many doses of both the tri-valent and experimental mono-valent live polio vaccines was quoted by India's Tehelka (The People's Paper): "She is having polio drops ever since she was four days old. She has had over a dozen doses of the polio drops....There must be some thing wrong with the polio drops if even after so many doses my child has contracted polio. The government should test medicines before they are used. Pata nahin bachchoo ko kya pila rahin hain!" (Don't know what they are making my child drink), she adds."
One brave and clear thinking pediatrician in New Delhi, Jacob Puliyel, has written a letter to the editor of The Lancet, which published an article in April 2007 about the experimental high potency polio vaccine campaign in India. "We are shocked and dismayed that Lancet should have published the paper on the protective efficacy of monovalent oral Type 1 poliovirus....having overlooked the serious ethical issues involved...... What was introduced, according to this article, was a new vaccine that was five times more potent than previous vaccines, presumably also with the increased likelihood of adverse effects. No informed consent was taken, nor was the public told that the vaccine was experimental. " He protested experimentation on children by Indian health authorities, who licensed the experimental vaccine, and WHO authorities, who are running the mass vaccination program. "The oversight body that introduced this experimental vaccine should also have monitored adverse effects," he wrote to The Lancet. "Data from Uttar Pradesh show an increase in the incidence of non-polio Acute Flaccid Paralysis since the introduction of the monovalent vaccine."
Now that Dr. Puliyel, head of pediatrics at a New Delhi hospital, has spoken up about scientific and ethical lapses connected with the experimental polio vaccine program - will he be kicked out of his hospital and have his medical license revoked? Maybe not. But it is very likely that government health authorities and pediatrician colleagues will make his life miserable.
This kind of vaccine experimentation without informed consent does not happen only in India or Africa or South America among disadvantaged populations. This kind of exploitation also happens in America.
In what turned out to be a deadly experiment conducted during the mid-1980's using a high potency Edmonston Zagreb measles vaccine, vaccinologists first injected the experimental measles vaccine into four month old babies in Africa, the Middle East, Mexico and Haiti at 10 to 500 times the usual dose levels to try to overcome natural maternal antibodies and replace them with vaccine induced antibodies. Even though researchers in Africa knew half way through the experiment that a higher than expected number of girl babies were dying six months to three years following vaccination, the CDC moved the high potency measles vaccine trials to Los Angeles in 1990.
With the help of Kaiser Permanente, more than 1500 six month old primarily black and Hispanic babies in inner city LA were injected with the high potency EZ measles vaccine between June 1990 and October 1991. One child in the vaccine trial died from a bacterial infection that researchers insisted was unrelated to vaccination.
In June 1996, then CDC Director David Satcher admitted that an NIH investigation of the LA trial found that informed consent regulations had been violated: the LA parents were never told that their babies would be injected with an experimental vaccine that had never been licensed by the FDA for use in the U.S. Shortly after, researchers reported that infants with the highest antibody responses to high potency measles vaccine have the most profound immune suppression.
How high are the antibody responses of children in India who are repeatedly vaccinated for polio, especially after being given high potency polio vaccine? And how many are suffering immune suppression, which is followed by wild-type or vaccine strain polio or unexplained Acute Flaccid Paralysis?
The militaristic approach taken by vaccinologists employed by governments and the World Health Organization unfortunately includes conducting vaccine experiments without the informed consent of participants. Their assumption that proof of efficacy is all that matters because injuries and deaths following vaccination are always a "coincidence" is both unscientific and dangerous.
The human right to informed consent to all medical interventions which carry a risk of injury or death, including vaccination, should be made law in every country and there should be criminal and economic sanctions for all those who violate it during the course of clinical research or the practice of medicine.
PULSE POLIO BUNGLE
UNTESTED VACCINE SURFACES IN POLIO OUTBREAK
A potent new vaccine introduced in Uttar Pradesh by the WHO has had no safety tests; the rash of new polio cases in the state may’ve been caused by the vaccine itself, reports Mihir Srivastava http://www.tehelka.com/story_main33.asp?filename=Ne280707untested_vaccine.asp
Saniya’s is not the only case. There are 15 cases of Type I polio spread across Uttar Pradesh (There are also 41 cases of Type II polio which takes the total count to 56). While there has been no reported Type I case in the endemic Moradabad, the new cases have been reported from eastern and central Uttar Pradesh; so instead of just a region, cases of wild polio are being reported from all over Uttar Pradesh now.
Saniya’s mother, Noorjahen, is furious. “She is having polio drops ever since she was four days old. She has had over a dozen doses of the polio drops. We came to know about her polio when she got a high fever. She could barely manage to stand, could not walk at all, after the fever. We took her to the local hospital where they did a stool test. We were later told that she has polio,” she recounts. “There must be some thing wrong with the polio drops if even after so many doses my child has contracted polio. The government should test medicines before they are used. Pata nahin bachchoo ko kya pila rahin hain!” (Don’t know what they are making my child drink), she adds.
Mistrust is not only rife among the patients’ families, it has also gripped the doctors and field operatives overseeing the vaccination project. Add to this the latest controversy about the MOPVI vaccine, introduced in India by the World Health Organisation (who), and the organisation’s National Polio Surveillance Project (npsp), and you get a sense of the callousness plaguing the polio campaign.
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When the MOPVI was launched in India in mid-2005, there was no mention that it was a new vaccine, and therefore no need was felt to examine whether it had been tested. The impression created at the time was that this vaccine had earlier been used in the 60s and 70s in some other countries. The project manager of the npsp, Dr Hamid Jafari, confirmed this while talking to Tehelka.
In contrast to this position, the April 21, 2007, issue of the renowned medical journal, Lancet, carried a study titled “Protective efficacy of a monovalent oral Type 1 poliovirus vaccine: a case-control study by Grassly NC, Wenger J, Durrani S, Bahl S, Deshpande JM, Sutter RW, Heymann DL and Aylward RB”. On pages 1356-1362 it says: “A high-potency monovalent oral type 1 poliovirus vaccine (mopv-i) was developed in 2005 to tackle persistent poliovirus transmission in the last remaining infected countries. Our aim was to assess the efficacy of this vaccine in India.”
This clearly means that the MOPVI is a new, untested vaccine and its use was part of an experiment. This news has outraged the Indian medical community. If this vaccine was new, did the who and npsp test its safety? Head of the pediatrics department of Delhi-based St Stephen’s Hospital, Jacob Puliyel, took up the matter with Lancet. In his strong-worded letter to Lancet’s editor, he wrote: “We are shocked and dismayed that Lancet should have published the paper on the protective efficacy of monovalent oral Type I poliovirus...having overlooked the serious ethical issues involved.” He went on to write, “What was introduced, according to this article, was a new vaccine that was five times more potent than previous vaccines, presumably also with the increased likelihood of adverse effects. No informed consent was taken, nor was the public told that the vaccine was experimental. Efforts were made to give the impression that the monovalent vaccine was not new.”
Lancet asked the authors of the article to respond to the questions raised by Puliyel. In their reply, the authors bypassed the question whether the vaccine was new or not, and put the onus of use of this vaccine squarely on the government of India. “The vaccines assessed were licenced for administration in India by the national regulatory authority, the Drugs Controller General of India. The MOPVI formulation assessed in our study has been used since mid-2005 by the Government of India, and now in over 20 countries around the world.”
When Tehelka asked the same question to Jafari, he said it wasn’t a new vaccine. Then why does this paper in Lancet say so? “It has been interpreted wrongly,” Jafari said.
Puliyel had another serious objection. He said administering MOPVI without examining its potential harmful effects amounts to experimentation on human subjects. The question that npsd and who have to answer is why polio drops that are five times more potent, which means they carry five times more of the live poliovirus, was indiscriminately administered. Would this not result in overexposure to the live poliovirus and possibly result in vaccine-induced polio? “The oversight body that introduced this experimental vaccine should also have monitored adverse effects,” wrote Puliyel to Lancet. Further, he mentioned: “In the absence of proper post-vaccination surveillance of adverse effects, we have to rely on indirect evidence of possible adverse effects available from the npsp. Data from Uttar Pradesh (where Grassly and colleagues show improved vaccine efficacy) show an increase in the incidence of non-polio Acute Flaccid Paralysis (AFP, or the weakness of limbs) since the introduction of the monovalent vaccine.” Doctors in UP are worried about this development. “We want the nature of AFP in these cases to be investigated. It could be due to over exposure to the polio vaccine,” said a senior doctor in Lucknow who has overseen the polio immunisation programme in UP for years.
These apprehensions are not without reason. Of the 10,264 reported cases of AFP, 209 were cases of polio. Of the remaining 10,055 only 2,553 were followed up. npsp data reveal that approximately 4,800 cases had residual paralysis or died after acquiring in 2005 non-polio AFP. “The situation was even worse in 2006 after just six doses of MOPVI. It is not surprising that npsp is not keen on the follow up of these cases,” says Puliyel.
In their reply to Lancet, the study’s authors have ruled out this possibility completely. Interestingly, they cite no study to support their assertion. The increase in AFP cases is attributed to better surveillance and reporting. “The increase in AFP cases began before MOPVI was introduced, and occurred across India, including states where MOPVI has not been used. The introduction of MOPVI is not, therefore, the cause of the increase in cases of AFP,” the authors wrote.
Disagrees Puliyel: “This cannot be ruled out unless tested.” In their reply to Lancet, the authors have written: “Poliomyelitis cases are confirmed only when the poliovirus is identified in the stools of a patient with Acute Flaccid Paralysis (AFP). However, it is impossible to collect stool samples from all such patients.” They have also said: “When we are into the business of polio eradication we are interested in polio and nothing else.”
Jafari said the question of overexposure does not exist. “Each time a vaccine is given, it strengthens the child’s immunity against subsequent doses,” Jafari said. But he failed to explain why infants like Saniya, who have had multiple vaccination, have contracted polio. On the question of whether the rising cases of AFP are a possible fallout of overexposure to polio vaccines, Jafari said, “We know by our 50 years of experience in polio vaccination that the vaccines are safe. There are many studies in place, even in India.” None of these “studies” was quoted in the detailed reply to Lancet.
Then why does polio survive in the Hindi heartland? As usual, the who blames the state government and its poor health infrastructure. Dr LB Prasad, director general of UP’s Directorate of Family Welfare, counters: “Our job is to give vaccines to every child in Uttar Pradesh. We have approximately a 90-percent coverage against the required 80 percent. Each child has received multiple doses.”
Another question is why are local authorities always held responsible for any failure? Did the who care to check the efficacy of its own vaccine? “We are constantly looking at the efficacy aspect of the vaccines,” said Jafari. “That is what led to the introduction of MOPVI.” But if that is the case, why are children, who have been vaccinated more then 20 times, still carrying polio? “The efficacy of the vaccine depends on climate conditions, hygiene, population density, etc. They may not be 100 percent effective,” concedes Jafari. While Jafari does not consider efficacy the real issue, Principal Secretary of the UP’s Health department, Arun Mishra, informed Tehelka: “The efficacy of the MOPVI is being tested by the Indian Council of Medical Research. The results are awaited.”
» Writer’s e-mail: mihir@tehelka.com