|The Cervical Cancer Bazaar |
YOUNG GIRLS ARE BEING GIVEN ANTI-CANCER JABS, WITH DUBIOUS RESULTS, FIND SHANTANU GUHA RAY AND KUNAL MAJUMDER
On January 21 this year, Venkatamma found the motionless body of her 13-year-old daughter on the floor. At first she thought her daughter — a student of Lakshminagaram Residential Hostel — had consumed pesticide to commit suicide, possibly after a failed love affair. But the pesticide bottle was intact on the shelf. Sarita was rushed to the nearest healthcare centre where a small team of paramedics and a doctor confirmed that it wasn’t a case of poisoning and referred Sarita to the Bhadrachalam area hospital, 25 km from their house in Anjupaka village. En route, Sarita had a severe epileptic fit. Doctors at the hospital declared that she was “brought dead” and conducted a postmortem. The report was not handed to the parents. At the Nallipaka Public Health Centre (PHC)—which records all births and deaths in the region — Sarita’s death was recorded as suicide. Nageshwara and Venkatamma refused to accept this and cremated their daughter under protest.
“My daughter did not commit suicide. She did not consume poison,” Nageshwara says firmly. “She had started having fits after the vaccine. She told us, so did the hostel supervisor. The hospital officers are lying.” Dr R Balasudha, a paramedic at the PHC in the Narshapuram block under which Anjupaka village falls, adds: “Sarita was not dead when she was brought to the PHC. She did not consume any poison. She was having severe bouts of epileptic attacks and was very, very sick.”
Sarita’s hapless parents learned of a similar death on August 30 last year in Yerragattu village, 60 km from Bhadrachalam. Another 13-year-old, Sodi Sayamma, had died there, with doctors calling it a suicide. But Sayamma’s parents, also farm labourers, said their daughter had not consumed poison or hanged herself. In both cases, the PHCS confirmed the girls had not consumed poison and referred the cases to the Bhadrachalam area hospital. Interestingly, the PHCs — one in Gowrideviteta block covering Yerragattu village and another in Narshapuram block — were responsible for administering the vaccine for the Human Papilloma Virus (HPV) in these villages.
The HPV, which is transmitted sexually, is one of the many known causes of cervical cancer. Gardasil, the commercially licensed HPV vaccine produced by Merck Sharp and Dohme (MSD), an affiliate of US-based pharmaceutical giant Merck and Co Inc, is supposed to prevent cervical cancer when administered to pre-puberty girls. The Indian unit of the Seattle-based PATH, one of the world’s largest healthcare NGOs, began the HPV vaccination drive on July 9 last year as a demonstration project in Andhra Pradesh and Gujarat. Part of the goal was to vaccinate 14,000 girls in Khammam district — a large percentage of them from poor, tribal families — with three doses of Gardasil. The three zones selected in the district were Thirumalayapalem (urban), Kothagudem (rural) and Bhadrachalam (tribal).
Sources in Hyderabad say that D Nagender, the Andhra Pradesh Health and Family Welfare Minister, worked closely with PATH and the Indian Council of Medical Research (ICMR) on the project. The ministry says the blocks were chosen because of high incidence of cervical cancer in the region. But this claim is disputed by many. “There is no document available to prove this. It is a blatant lie,” says NB Sarojini of the Sama Resource Group for Women and Health, which, along with 80 other health networks and medical practitioners, sent a memorandum last October to the health ministry on the issue.
In Khammam, besides Sayamma and Sarita’s deaths, around 120 students developed complications after the vaccination — ranging from epileptic fits, allergies, diarrhoea, dizziness and nausea. News of this first began to emerge in small reports on TV 9, a regional news channel. Dr R Balasudha, a medical officer at the Narshapuram PHC, confirms this. This PHC was one of the four targeted for the drive in Bhadrachalam block from July 16, 2009 to February 28, 2010. Dr Shekhar, associated with the Nallipaka PHC, who had a target of 2,400 children but could manage only 1,800 till February 27, adds: “Many developed complications, but we don’t know if they turned serious since we aren’t in touch with the girls.”
“If there is a problem with the vaccine, it is for MSD to respond, not us,” says the PATH official, adding that the NGO plans to administer the vaccine to 18,000 more girls in Khammam this year, to help determine if this vaccine can be included in the National Vaccination Scheme. “We firmly believe this is the least risky vaccine available to prevent cervical cancer and we want to help make it available to the poorest sections of our society. We are bound by confidentiality clauses and cannot reveal any details about any ‘adverse events’. All we can say is that we are monitoring it very closely and there is nothing to be concerned about,” says another PATH representative. “Reporting such incidents out of context will jeopardise this entire public health programme.”
Shockingly, however, Dr B Jaikumar, the District Immunity Officer of Khammam and the man responsible for the drive there, says he has no idea why the region was selected. He does not have any statistics regarding major cancer incidence in the area, nor do he or his team have any means to check the effectiveness of the vaccine or measure its afteraffects. So why was the vaccine administered? “I am not aware of the reasons,” says Jaikumar. “The Commissioner of Family Welfare said we have to do it here.” Ask him if his district was being used as a human laboratory, and he replies, “The tests have been done in the international market.” But Jaikumar himself has not read any international medical literature on the vaccine: It is for the state government to read such stuff, not him, he says.
THE INDIAN cervical cancer market, therefore, which accounts for a quarter of the $10 billion world market, is far too big to be ignored by global drug makers. Two of the biggest players in India are MSD, the Indian subsidiary of Merck, and Glaxo SmithKline which sells the HPV vaccine under the brand name Cervarix. By all accounts, a tough battle for market share looms. (One of the PATH-ICMR study’s goals is to compute what the HPV vaccine will cost the national exchequer if it were to be included in India’s public health programme.)
In the UK, where Cervarix is administered, the first death was reported in September 2009. Natalie Morton, 14, died after the vaccine jab. The European Medicines Agency (EMEA) also mentions deaths in Germany and Austria that are allegedly linked to Gardasil jabs. Since its approval in 2006, Gardasil has been blamed for more than 70 deaths and thousands of reports of adverse reactions across the US and Europe. Importantly, in a written communiqué to TEHELKA ( see box ), Merck itself admits, “As of September 1, 2009, there have been 15,037 VAERS reports of adverse events following Gardasil vaccination. Of these, 93 percent were classified as reports of non-serious events, and seven percent as serious events.”
While these deaths may be contested, or only ambiguously linked to Gardasil, it is difficult to overlook the fact that the VAERS has reported thousands of adverse events in the US following HPV vaccination since 2006 — a fact corroborated by the US Center for Disease Control and Prevention. Among these adverse events are listed neurological disorders affecting voluntary muscle activities, including speaking, walking, breathing; immune system malfunctions; and inflammation of the pancreas.
“The West became aware of the dangers of the HPV vaccine only because of its stringent screening systems, where the after-effects of the drug were routinely monitored. But India lacks this system,” says Dr Rukmani Rao of the Hyderabad-based Gramya Resource Centre for Women.
There are other charges. Though PATH claims the vaccine is only effective if administered to pre-puberty girls, other experts say the age group selected for administering the vaccine was wrong. “Cervical cancer only affects the uterus of middle-aged women, so why are we vaccinating girls whose sexual organs are still developing?” asks Dr S Prabhakar, a physician who has worked in the tribal areas of Bhadrachalam for nearly a decade.
The absence of an umbrella cover under the HPV vaccine is a key point. Dr Gopal Dabade, a member of the New Delhi-based All India Drug Action Network, says the efficacy of HPV vaccines remain highly unproven. The current Gardasil vaccine prevents infections arising out of two of the HPV subtypes (16 and 18) that may cause cervical cancer and also HPV subtypes (6 and 11) that can lead to genital warts. It is true that subtypes 16 and 18 account for 70 percent cases of cervical cancer globally. “But there are several other causes for cervical cancer than HPV. It can happen through multiple sex partners and unhygienic conditions. Causes for cervical cancer differ from region to region,” says Dabade. Karat agrees. “I’m concerned that they are promoting the vaccine as a solution to cervical cancer. There is a complete lack of transparency. HPV is only one particular virus that causes cervical cancer — what about the rest?”
As ever, the lack of transparency in India is one of the biggest hurdles. Highly placed sources say that once the order came from the Andhra Pradesh Family Welfare Department, consent letters went out to parents of thousands of girls, many of them staying in government hostels. The note claimed that the vaccine, offered free by Merck in Khammam and Glaxo SmithKline in Vadodara, Gujarat, would prevent HPV infection. But it failed to mention the full range of the vaccine’s numerous side-effects. The students were told to get their parents’ signature on the specially printed literature — TEHELKA has a copy — that peculiarly reads: “If you do not take this vaccine, please do not worry. You will not be punished in any way.” For many girls in the government schools and their parents, it was a sign to fall in line.
“This is what I was hinting at. The demonstration project in India is nothing but pushing gullible girls as guinea pigs,” says Dr Rao. She finds support from Dr Y Madhavi of the Delhi-based National Institute of Science Technology and Development Studies, who points to the lack of conclusive data regarding the length of immunological protection that the vaccine confers against HPV subtypes 16 and 18. Studies so far have shown the vaccine offers protection only for five years. “Since the long-term efficacy of and protection by the vaccine is unknown we cannot claim that even 60-70 per cent protection will be achieved,” she says.
Harald zur Hausen, who won the 2008 Nobel Medicine prize for discovering that the HPV causes cervical cancer, says that even the best-case scenario of HPV vaccination will require booster doses. In an article published in the medical journal, The Lancet, on February 20 this year, Eric J Suba and Stephen S Raab on behalf of the Viet/American Cervical Cancer Prevention Project, said developing countries should allocate their limited resources to cervical screening, rather than HPV vaccination, until it is proven that HPV vaccines are effective for cervical cancer prevention. Did anyone in India read the article, asks Sarojini.
It seems no one did. Not even those who started the much-hyped vaccination programme.
(With field reports from Khammam, Hyderabad, Buxar (Bihar) and New Delhi)
From Tehelka Magazine, Vol 7, Issue 11, Dated March 20, 2010
The article written by Dr. Prashant Mangeshikar goes like this,
ICMR orders Suspension of Cancer Vaccine Program after 4 of 120 girls aged 10 to 14 years die following Gardasil vaccine.!!! Complications: stomach disorders, epilepsy, headaches, early menarche reported!
ICMR orders Suspension of Cancer Vaccine Program
At a press conference in New Delhi yesterday, — along with representatives of the All-India Democratic Women's Association (AIDWA), Saheli, Sama, All-India People's Science Network, and the Jan Swasthya Abhiyan — Ms. Brinda Karat accused the pharmaceutical company of misleadingly promoting the vaccine as preventive for cervical cancer as it prevented the cancer of only two strains of hundreds that caused cervical cancer.
Ms. Brinda Karat elaborated: “The literature circulated in the project makes outright false statements about its safety, efficacy and duration of effectiveness. The girls and their parents have been told through the project documents that the vaccine will give life-long immunity, has no side-effects other than minor ones like fever and rash, and would not affect future fertility of the young girls,”. In this case, the children from the Scheduled Castes, the Scheduled Tribes and the Muslim communities, who are economically poor, were used for experimenting. A number of children were from families displaced from Chhattisgarh, who could not even understand Telugu.
Ms. Karat demanded that each vaccinated girl be examined by an independent authority to assess the range and incidence of side-effects, and sought an enquiry into the use of the National Rural Health Mission (NHRM) logo on the vaccination card given to the girls, which was titled ‘HPV Immunisation Card.'
“The vaccination is not part of the universal immunisation programme of the country,” she said, adding that while PATH claimed it was a promotional programme for the vaccine in India, the ICMR had clarified that it was, indeed, a clinical trial.
Why do American organizations (Seattle based PATH) use Indians rather than using their own population as guinea pigs! Are we a cheap population? No, our people are gullible and am sure the Indian promoters will have been given big funding and possible bribing to induct these vaccines in public health programmes. More often and am pretty sure that neither the girls nor their parents may have been informed regarding their participation in the trial nor must have been told of the side effects of the drug. A literature search will show that it does have side effects Approximately 6% of reported side effects were serious and included 32 reports of death. Medically important serious events included the following:
Deep vein thrombosis
Transverse myelitis (inflammation across the width of the spinal cord)
Inflammation of the pancreas
Blood clot in the lung
I am shocked at the manner in which some of my gynaec fraternity and am told even pediatricians are advocating Cervarix and Gardasil (Anti HPV vaccine). Do you know my oncosurgeon friends have not given these vaccines to their own daughters.
Are Indians really that promiscuous than the Americans that we have to start worrying about the HPV virus! NO!
Is the vaccine really effective against all strains of the virus: Answer NO. Moreover, the vaccines are effective only in 30% of the cases.
Studies have shown that the HPV virus does not creep within a monogamous couple, and remember we Indians are more likely to be monogamous.
The Companies have been harping the Tata Memorial Hospital reports that 74000 women die of cervical cancer every year which means that one woman in India dies of Cancer Cervix every SEVEN minutes. While this maybe true, remember that this is a survey covering Rural areas of India. The Urban woman can afford the vaccine as it is expensive. The companies claim , they told me, that it is compulsory in USA and Europe for all teenage girls to be administered the vaccine.
Three years ago, I asked an audience of 3000 plus women gynecologists whether they had a PAP smear on themselves as part of their preventive health program, It was surprising that not even 1% had had a PAP smear!
Rather than the vaccine, it is the PAP smear that should be made compulsory in all sexually active women.