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From Tehelka Magazine, Vol 7, Issue 11, Dated March 20, 2010
CURRENT AFFAIRS  
cover story

The Cervical Cancer Bazaar

YOUNG GIRLS ARE BEING GIVEN ANTI-CANCER JABS, WITH DUBIOUS RESULTS, FIND SHANTANU GUHA RAY AND KUNAL MAJUMDER

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Photo: VIJAY PANDEY

PREVENTION OR TRAUMA?

HPV vaccine controversy
TESTED AND MARKETED TO MILLIONS OF GIRLS AND YOUNG WOMEN.

HPV vaccine’s side-effects
EPILEPTIC FITS, BLOOD DISORDERS, ARTHRITIS, NEUROLOGICAL PROBLEMS AND SEIZURES

Key global players
SEATTLE-BASED MERCK, SHARP & DOHME PRODUCES GARDASIL, WHILE GLAXO SMITHKLINE MAKES CERVARIX

The Indian vaccine market
ESTIMATED AT NEARLY $2.5 BILLION, THE INDIAN CERVICAL CANCER MARKET ACCOUNTS FOR A QUARTER OF GLOBAL SALES. IN INDIA, 78,000 WOMEN DIE OF CERVICAL CANCER EACH YEAR

EACH TIME Nageshwara and Venkatamma are asked about Sarita, the farm labourers point to a framed photograph of their daughter. And then they huddle near the entrance of their one-room house in Khammam district of Andhra Pradesh and weep inconsolably, recounting a tale of death that came home without warning.

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).

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LETHAL DOSE? Maramma’s daughter Sayamma died within seven weeks of being vaccinated
Photo: KUNAL MAJUMDER

BUT THE drive raises serious ethical questions. Did the producers of this drug and their field partners declare the full range of possible side-effects? Did the parents of these minors give “informed” consent? What is the criterion on which the target population for the vaccine was selected? And are there sufficient screening mechanisms in place to report and check on any “adverse events” or side-effects?

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.

COUNTERPOINT
REPRESENTATIVES OF PATH, AN NGO, RESPOND TO QUESTIONS ON THE CERVICAL CANCER VACCINATION DRIVE

‘IT IS AN OBSERVATIONAL STUDY TO COLLECT DATA’

REPRESENTATIVES OF PATH, AN NGO, RESPOND TO QUESTIONS ON THE CERVICAL CANCER VACCINATION DRIVE

imageWhat is the aim of the HPV vaccine drive?
The vaccination will prevent girls aged between 10 and 14 years from getting the infection when they grow up and attain the age when cancer of the cervix occurs. The PATH-ICMR Postlicensure Observational Study of HPV vaccination in Khammam and Vadodara is not a clinical trial. The vaccine used in the study has already been licensed by the Indian Government.

What are the benefits of introducing an expensive vaccine like Gardasil in India?
The study is conducted to generate critical data and experience for evidence-based decision-making about public sector immunisation programmes as part of a broader cancer-of-thecervix prevention and control strategy. Similar studies are being conducted in Peru, Uganda and Vietnam. This is to simply keep India prepared for the day when these vaccines become affordable.

Why are you experimenting with the HPV vaccine in rural areas?
Three blocks of Khammam and Vadodara have been selected to reach out to all areas that reflect the population in the state. The state governments and Regional Cancer Centres selected the districts on the basis of distribution of cervix cancer cases.

What was PATH’s role?
The governments of Andhra Pradesh and Gujarat are conducting the demonstration project in the state with technical assistance from PATH and the Indian Council of Medical Research (ICMR). The vaccine producers — Merck (MSD) and GlaxoSmithKline (GSK) — have donated vaccines for the project.

Is PATH aware of the unproven nature of the HPV vaccine?
These vaccines are already available in the markets in India and many other countries. These are not experimental products; they are approved, commercial products.

In Khammam, TEHELKA came across two deaths caused by the Gardasil vaccine.
Similar to all other vaccinations, so also for HPV vaccinations, all Adverse Events Following Immunisation (AEFI) for HPV vaccinations are investigated and reported through a process set up by the Ministry of Health & Family Welfare.

PATH claims the side-effects associated with the vaccine are negligible — nothing more than a “pain in the arm after a jab”. However, organisations like the US-based Judicial Watch and the Vaccine Adverse Events Reporting System (VAERS), a US government body, list a range of potential side-effects associated with the Gardasil vaccine. Among them are blood clots, auto-immune disorders, seizures, epileptic fits and severe allergies.

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.”

Click here to enlarge the image
the controversial Glaxo SmithKline campaign that was banned by the Health Ministry

“This is a very serious cover-up,” says CPM leader Brinda Karat, who plans to raise the issue in Parliament. “India needs to be careful about the side-effects of these vaccines and a detailed investigation should be done by the Health Ministry as to why these tribal and semi-literate girls were picked for such a drive. It is a wrong notion, nurtured by many, that tribal girls are more sexually active and hence should be targeted for such drives,” says Karat, who came to know about the matter recently through the Andhra Pradesh unit of the All India Democratic Women’s Association (AIDWA).

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NUMBERS GAME NGO PATH says 32,000 girls in the 10-14 age group will be vaccinated in Khamman during the first phase
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IMMUNE? District Immunity Officer Dr B Jaikumar was responsible for the vaccination of 14,000 girls in Khammam district
Photo: KUNAL MAJUMDER

PATH, which asserts that it has followed every international guideline in conducting the demonstration project, however, seems to be trying hard to limit the damage caused by the deaths and the disclosures of side-effects. “We were only commissioned by the Welfare Department of the Andhra Pradesh Government and were not involved in physically administering the vaccine. We were the technical partner and just went along with the state government team,” says a top PATH official, without disclosing the amount the organisation received to implement the demonstration project, titled the PATH-ICMR Post-licensure Observational Study of HPV vaccination funded by the Bill and Melinda Gates Foundation.

“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 BIG, GLOBAL CLAMOUR OVER HPV VACCINE

‘Reports are coming in on a daily basis of young girls and women affected by adverse reactions to the HPV vaccine’
AMERICAN CHRONICLE, Feb 27, 2010

‘We will not know for many more years whether HPV vaccination will prevent cancer or, in the worst case, do harm’
THE LANCET, Feb 20, 2010

‘An investigation has been launched after a 14-year-old girl died upon receiving a cervical cancer vaccination’
THE GUARDIAN, Sept 29, 2009

‘Gardasil has been linked to 32 deaths and shows higher incidences of fainting and blood clots than other vaccines’
ABC NEWS, Aug 19, 2009

‘Young women given the vaccine are up to 26 times more likely to have lifethreatening allergic reactions’
SYDNEY MORNING HERALD, Sept 7, 2008

‘Ad campaigns for the vaccine have created a false sense of risk by shifting bet ween the common virus and cancer’
TODAY’S VANCOUVER WOMAN

The smokescreen of “international tests” is a disturbing one. It is hardly a surprise that global manufacturers of cervical cancer vaccines are betting big on India. According to the World Health Organisation, cervical cancer is the most common cancer affecting women in India. It kills eight women every hour. In fact, the WHO estimates that of the 130 lakh women annually diagnosed with cancer in the country, over 74,000 die of cervical cancer. This accounts for more than a quarter of worldwide deaths due to cervical cancer — which is globally the second-most common cancer after breast cancer. And Indian women have a 2.5 percent lifetime risk of getting cervical cancer, double the worldwide figure of 1.3 percent.

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.)

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FATAL SHOT (above) Nageshwara and Venkatamma grieve for their daughter Sarita (below)
Photo: KUNAL MAJUMDER
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Alarmingly for India then, the Gardasil vaccine is imputed to have caused 61 deaths in the US from June 2006 onwards, prompting a big media backlash against Merck ( see box ). Among cases listed as Gardasil-linked deaths by the VAERS, a US government body, an 11-year-old girl vaccinated in May 2007 with a dose of Gardasil died three days later due to a severe allergic reaction. In another case, a 12-year-old girl with no reported medical problems died in her sleep of unknown causes on October 6, 2007, three weeks after receiving a Gardasil shot. In yet another case, a 20-year-old woman, again with no medical history, who was vaccinated on April 1, 2008, died four days later.

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.

COUNTERPOINT
DR SWASHRAYA SHAH, MEDICAL DIRECTOR, MSD INDIA, ATTEMPTS TO SET THE RECORD STRAIGHT ON THE GARDASIL VACCINE

‘NO VACCINE OR MEDICINE IS WITHOUT RISK’

DR SWASHRAYA SHAH, MEDICAL DIRECTOR, MSD INDIA, ATTEMPTS TO SET THE RECORD STRAIGHT ON THE GARDASIL VACCINE

imageWhat was the nature of agreement between PATH
and Merck?

PATH is conducting a demonstration project along with the Indian Council of Medical Research in India. MSD India’s (Merck) commitment is to provide vaccines for the project in Andhra Pradesh.

Did Merck keep silent about the unproven nature of
the HPV vaccine?

Gardasil is the result of over 10 years of research and development. As part of the rigorous scientific vaccine clinical development programme, clinical trials evaluating the efficacy and safety of the vaccine have included more than 25,000 women from 33 countries. While no vaccine
or medicine is completely without risk, leading international health organisations throughout the world have reviewed all of the safety information available to them about Gardasil and continue to recommend its use.

In Khammam, TEHELKA came across two vaccine-linked deaths…
As part of the rigorous scientific vaccine clinical development programme, clinical trials evaluating the efficacy and safety of the vaccine have included more than 25,000 women from 33 countries across the world. The Federal Vaccine Adverse Event Reporting System (VAERS) in the US reported as of September 1, 2009, that there had been 15,037 adverse events following Gardasil vaccination. Of these, 93 per cent were classified as non-serious events and seven per cent as serious events.

ONE COULD concede that for those who back Gardasil, these may seem small numbers in the cost-benefit ratio. Of 40 million women administered the HPV vaccine globally, how should one view 70 ambiguously linked deaths or over 15,000 adverse events, of which an average of 7 to 10 percent are deemed serious? The answer loops back to fair disclosure of risk, informed consent and sufficient screening mechanisms.

“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.

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PLANNED MOVE Welldesigned cards invited tribals and non-tribal girls for the vaccination drive in Andhra Pradesh

“I don’t understand why they selected Khammam for this vaccine. Why couldn’t they experiment in Delhi or Hyderabad?” asks SVRV Prasad, coordinator with ASDS, an NGO working with tribal-related development work in the region. P Jyoti, state president of the All India Democratic Women Association in Andhra Pradesh, agrees: “There are more girls in greater Hyderabad. Why Khammam? It raises a lot of suspicion. They are using it on poor girls who lack education and do not have proper knowledge of the vaccine and its reactions,” she says.

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.

I DON’T KNOW WHY THE HPV VACCINE IS BEING INTRODUCED HERE. WE DID WHAT THE COMMISSIONER OF FAMILY WELFARE TOLD US

DR B JAIKUMAR, District Immunity Officer, Khammam

OTHER KEY questions involve efficacy and expense. Do the HPV vaccines cover all kinds of cervical cancer? Can the government afford such an expensive vaccine? The answers look pretty dismal. The market cost of Gardasil is Rs 2,000 per jab: three jabs would cost Rs 6,000. For many like Rao, the entire drive is a hoax. “Even after paying Rs 6,000 for a vaccine, one has to still go for cervical cancer screening. How many of these parents or girls know that it is much cheaper to have oneself screened than to spend so much on a vaccine that may or may not prevent cervical cancer? What place can such a vaccine have in a country where the per capita annual public health expenditure is a mere $10?” asks she.

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?”

UNITED STATES
Over 15,000 adverse reactions and 61 deaths related to HPV vaccine have been reported to the authorities

UNITED KINGDOM
The first death, of a 14-year-old schoolgirl in Coventry, was reported in September 2009

These criticisms are obviously starting to have impact. A high-profile print ad campaign for the cervical cancer vaccine was launched last year by Glaxo, which claimed its vaccine was a cure-all. Merck was to follow with its own campaign. However, four months into the campaign, the Drug Controllers’ Office, that works directly under the Ministry of Health and Family Welfare, issued a notice to Glaxo to withdraw its campaign.

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.

THERE IS NO DOCUMENT TO PROVE THAT KHAMMAM HAS A HIGH RATE OF CERVICAL CANCER. THIS IS A BLATANT LIE

NB SAROJINI, Sama Resource Group for Women and Health

It would be wrong to presume, however, that the vaccination drive will be limited to only these two districts. A number of healthcare NGOs are checking out potential zones for more such drives in rural India. Consider the case of the nondescript village of Gadraul, 145 km from the Bihar capital, Patna. A team of paramedics descended on the village in Buxar district in December last and conducted a 45-minute workshop on the benefits of cervical cancer vaccines. Given the rosy picture painted, no one in the gullible audience thought to ask any questions. The team is now slated to return in May.

THERE HAVE BEEN 15,037 ADVERSE EVENTS LINKED WITH GARDASIL VACCINE IN THE US, ADMITS MERCK

“The myth in rural Bihar is that vaccines are the safest mode of prevention from any disease,” says Dr Bharat Singh of the Patna Medical College and Hospital. “Why blame just Bihar, very few Indian cities would have any definitive screening systems (that would check the after-effects of the drug).”

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INFORMED VOICE Nobel Laureate Harald zur Hausen says the HPV vaccine requires booster doses

Officials of the Union Health Ministry like Health Secretary K Sujatha Rao say there is no chance of this expensive vaccine being included in the National Immunisation Programme. In 2008, her predecessor Naresh Dayal had taken a similar line.

EUROPEAN UNION
The European Medicines Agency (EMEA) says two women died after being administered the Gardasil vaccine. The deaths occurred in Germany and Austria

AUSTRALIA
Rate of severe allergic reactions after Gardasil injection reported as 2.6 per 100,000 doses

But that the government has little real information about the vaccine is clearly evident. At a press interaction two weeks ago, Dr VM Katoch, the director general of Indian Council of Medical Research, said, “In India, there are seven to eight types of cervical cancer. Unfortunately, we do not have any real data. Hence, we do not know the magnitude of the pockets. We just have patchy information from some hospitals. So how much the vaccine is going to benefit a particular person, we do not know.” Repeated attempts to elicit responses from the Union Health Ministry proved futile.

“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.

WE DON’T HAVE ANY REAL DATA. WE HAVE SOME PATCHY FIGURES FROM HOSPITALS. SO WE DON’T KNOW ITS REAL BENEFITS

DR VM KATOCH, Director General, Indian Council of Medical Research (ICMR)

IF THE immunological protection lasts for only five years, is there a requirement for a booster? If booster doses are needed, and it is not known how frequently, what will be the impact of the booster doses on the safety of the vaccine? Who is to pay for the booster doses?

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)

WRITERS’ EMAIL:
shantanu@tehelka.com
kunal@tehelka.com

From Tehelka Magazine, Vol 7, Issue 11, Dated March 20, 2010

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