The widespread promotion of HPV {Human Papilloms Virus} Vaccines has been successsfully marketed by BigPharma, intially via the vaccine producers of the vaccine Gardasil by Merck & Co, and of the vaccine Cervarix by GlaxoSmithKline back in 2006.
From that point in time, BigPharma was joined in tandem by a majority of Governments around the world, together with en masse reporting by the global media, acclaiming that HPV vaccines were the first choice means of eradicating Cervical cancer, the fourth most common cancer in women globally with around 660,000 new cases and some 350,000 deaths in 2022.(1). For India, which accounts ror 21% of the global total, this amounts to 77,000 Cervical cancer deaths annually.
In India, while bemoaning that a global shortage of BigPharma HPV vaccines, together with their expensivness, had delayed the planned introduction of HPV vaccination of girls aged 12-14 years, until a “homegrown solution” emerged to supposedly solve the nation’s Cervical cancer dilemma.
In essence, the “homegrown solution” is the indigenously developed quadrivalent HPV vaccine, Cervavac. Developed by the Serum Institute of India, one of the largest vaccine producers in the world, Cervavac is currently priced at 2,000 rupees per dose, this being half of the cost of Merck & Co’s Gardasil and GlaxoSmithKline’s Cervarix with plans announced to produce 200 million doses. Further, as production is scaled up the Institute hopes to be able to make a dose of Cervavac available to the public at a price of between Rs 200-400 in the near future.
During her recent interim budget speech for 2024-25, Indian Finance Minister Nirmala Sitharaman emphasised the government’s commitment to actively “encourage” vaccination as a proactive measure against cervical cancer.This was seen as a significant announcement for women’s health in India, but affordability has not been a sole factor which has hindered the universal adoption of HPV vaccines in India. Rather, and additionally, when Merck & Co’s and GlaxoSmithKline’s HPV vaccines were introduced in India in 2009 issues around the safety of Gardasil and Cervarix emerged.
Introduced by the non-profit organisation PATH (Program for Appropriate Technology), a $3·6 million HPV post-licensure observational study involved around 25 000 girls in the states of Andhra Pradesh and Gujarat. Aimed at exploring appropriate vaccine delivery strategies and providing government evidence for informed vaccine decisions. the study came to a halt in 2010 following local media reports of the deaths of seven girls in the study, as too that an estimated 1,200 girls in the two states had suffered from serious side effects, including auto-immune disorders which required continued medical care and treatment.
The study was halted in 2010, and in addition to their petition to the Supreme Court, the complainaints [Kalpana Mehta, Nalini Bhanot and V. Rukmini Rao representing (Gramya Resource Centre for Women from Andhra Pradesh) explained their reasoning within their Counter Currents Commentary[3]. In brief they contended that “Gardasil and Cervarix were two unproven and hazardous HPV vaccines purported to prevent cervical cancer, marketed in India by MSD Pharmaceuticals Pvt. Ltd. (subsidiary of Merck) and GlaxoSmithKline Ltd. The petition challenged their licensing for use in the private sector and attempts to introduce them in the public sector; implicated the Drugs Controller for having licensed the vaccines without adequate research on safety and efficacy; the Health Ministry for not carrying out an enquiry into licensing of these vaccines as ordered by the Parliamentary Standing Committee on Health and Family Welfare in April 2010; and for failing to take any action on the report of the enquiry committee set up by itself despite all irregularities of PATH project.
Rather than looking at safety and efficacy HPV vaccines in India, the PATH project was intended to influence the government’s adoption of these vaccines into the public sector.
The petitioners were represented by the well known public interest senior advocate Colin Gonsalves of Human Rights Law Network who presented the case before the Supreme Court on January 7, 2013. The Supreme Court admitted the case and asked the Government of India to immediately file its reply in the matter.
PATH had initiated a project for the introduction of the two vaccines in India by signing an MoU with Indian Council of Medical Research (ICMR) even before they were licensed by the Drugs Controller of India. This project was funded by Bill and Melinda Gates Foundation who had substantial stakes in Merck that produced the vaccine and hence there was a direct conflict of interest. PATH was aided by ICMR in carrying out large scale trials in the states of Andhra Pradesh and Gujarat unethically and according to the petitioners with frank disregard for health of the targetted poor tribal girls.
The unethical nature of the study and deaths of girls became the subject of Governmental enquiry in 2010 when the matter was repeatedly raised by activists. This enquiry concluded that there were many gross violations in the project with respect to procedures for taking informed consent, and inadequate health facilities for dealing with adverse events and medical emergencies. Yet after two years of the enquiry the government had not even initiated a single action to redress the situation and to punish PATH and ICMR as admitted by Ghulam Nabi Azad before the Indian Parliament in December 2011.
In 2013 an Indian parliamentary committee recommended legal action against PATH, accusing it of violating ethical standards and national law[4]
The committee said PATH and several Indian institutions that were also involved with the study failed to follow proper procedures, adequately monitor events, or obtain informed consent from all participants. Indian officials announced the deaths were not related to the vaccine, being due instead to snakebite, suicide, etcera, which to this day beggars belief. Or as one bereved mother, reported “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.” And as an observng paramedic, Dr R Balasudha, at the PHC in the Narshapuram block under which Anjupaka village falls, agreed: “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.” [5]
Both the 2013 Supreme Court’s and Indian parliamentary committee recommendations of legal action against PATH may have muddied the reputation of the Melinda and Bill Gates funded NGO for a short while, but 2 years later the newly-elected Modi Government notified the Supreme Court in September of 2015 that “that no specific penalties could be imposed on the Bill and Melinda Gates Foundation-funded PATH for violating norms while conducting the vaccination trials on tribal girls in Andhra Pradesh and Gujarat’ [6]. Similarly, pointing out that the current legal regime had no provision for penalties, the Ministry of Health and Family Welfare expressed its inability to proceed against PATH despite a parliamentary panel recommending strict actions.
Disturbingly, the deaths and serious side effets of Gardasil did not escape the attention of Australian author Heen Lobato in her 2017 volume Gardasil: Fast-Tracked and Flawed [7]. Lobato’s global research on the subject documents the early history of cervical cancer and tracks its progression from a disease of obscurity to one of mainstream prominence. All up her calulations reveal that since the the experimental HPV vaccination program began in 2006 there have been at least 315 HPV vaccine-related deaths and more than 50,000 HPV vaccine-related adverse events. Lobato Includes the stories of vaccinated girls and boys who remain ill after receiving a vaccine purported to prevent a disease they were unlikely of ever encountered. She also records the voices of dissenters and resisters who call for an inquiry into HPV vaccines approved for use after a relentless propaganda campaign promoting a vaccine against a virus that many in their ranks had never heard of.
It must also be said that the adverse effects of HPV vaccines has not been lost on perhaps the world’s most litagation conscious population in the United States [8]. In an update of April 2024, there are currently approximately 200 product liability lawsuits filed against Merck & Co. in the US’s federal court system. Each involves similar allegations that the drug maker failed to disclose potentially serious health risks from the Gardasil vaccine, which has been widely administered to teens and young adults in recent years, to protect against the development of HPV infections and cervical cancer.
As parties have continued working to prepare a group of Gardasil cases for trial, injury lawyers are continuing to investigate and file new lawsuits for individuals whose long list of complications alleged due to the HPV vaccine include Autoimmune Diseases, Postural Orthostatic Tachycardia Syndrome, Premature Ovarian Failure, Premature Menopause, Polycystic Ovary Syndrome, Idiopathic Thrombocytopenic Purpura, Irregular Heartbeat or Tachycardia, Lupus, Neurologic Disorder, Brain Fog or Chronic Inability to Concentrate, Chronic Fatigue, Chronic Pain, Insomnia, Severe Headaches, Fibromyalgia, Nerve Damage, Menstrual Disorders, and Gastrointestinal Issues such as food intolerances, nausea, and/or vomiting)
Despite the daunting list of allegations, the currently filed cases are anticipated to represent only a small portion of the total number of Gardasil lawsuits that Merck will face in the coming months and years, as hundreds of additional claims have been forthcoming via the U.S. Vaccine Court, where claimants must initially bring any claims over HPV vaccine risks, and then wait at least eight months before transferring their claim to the U.S. District Court for a civil trial.
Noteworthy also, while the Gardasil federal Multidistrict Litigation was originally assigned to U.S. District Judge Robert J. Conrad, last month the Judicial Panel on Multidistrict Litigation reassigned the pretrial proceedings to U.S. District Judge Kenneth D. Bell, Sr., who issued the critical ruling in March of 2024 which granted permits for the lawsuits to move forward.
Over the past few years, The Hindu, has offered recommendations for India’s strategies for eradicating the national burden of cervical cancer. Initially in an editorial of late 2022, while citing the likely rollout of the indigenously developed HPV vaccine Cervavac by mid-2023, and simultaneously giving prominence to the essential need for the inclusion of screening programmes in order to detect early signs of the disease, and to allow time for treatment. [9]
Subsequently, in November of 2023 the Cervavax vaccine; (Serum Institute of India, Pune, India) was found to induce non-inferior antibody responses in girls and boys aged 9–14 years when compared with the Gardasil quadrivalent HPV vaccine licensed worldwide and targeting the same HPV types (Merck Sharp & Dohme, Harleem, the Netherlands). The authors also reported no significant difference in adverse events after vaccination of girls and boys aged 9–14 years vaccinated with the Cervavax vaccine versus girls vaccinated with Gardasil While reporting that there were no significant differences in adverse events after vaccination of girls and boys aged 9–14 years vaccinated with the new Cervavax vaccine versus girls vaccinated with Gardasil, regrettably in a glaring ommission with the actual number of adverse events passed unmentioned. Nonetheless, taken together, the results led to the licensure of Cervavax by the Drugs Controller General of India, the first vaccine manufactured in India to receive such approval [10]
On February 21 of the present year, The Hindu followed up with a further cruial editorial on India’s strategies re the national burden of cervical cancer [11]. Firstly underscoring that “A national cervical cancer control programme should be made accessible to all”, before asking the long-avoided question of India’s cervical cancer plans of “whether any programme to handle cervical cancer would be wholesome if it did not assimilate a screening aspect”; before going on to precisely make the editorial’s case in the following terms “Cancer of the cervix (literally, the neck of the womb) is unique among cancers because almost all the cases (99 per cent according to the World Health Organization) are linked to infection with the HPV virus whih is commonly transmitted via sexual contact. While most, indeed 90 per cent of HPV infections resolve spontaneously leaving girls and women to remain cervical cancer-free, persistent infection can lead to cervical cancer whih frquents Indian women down the track [most commonly when aged between 41 and 58 years]
While the editorial’s good news is couched in the availability of an HPV vaccine, the sobering fact is that the average national prevalence of cervical cancer screening hovers at just under an abyssmal 2%, with outcomes dependent on the stage of detection. Delving further, the editorial undersored that cervical cancer can be easily diagnosed in a public health setting with minimal tools: the human eye, a dilution of white vinegar, and a dab of of iodine, these being known as VIA and VILI tests whih seek out precancerous lesions and cancer, much before an advanced stage of the disease can be picked up with cytology. A simple, short procedure, cryotherapy, can then be done while the patient is awake, to destroy the abnormal growth.
In The Hindu editorial’s words “Given that it is easy to prevent, identify and treat cervical cancer, it is unacceptable that so many women are dying of the disease”. In an escape from “HPV Vaccine Mania, The Hindu advised that as the government rolls out its vaccination programme, it must also mandate screening right at the primary health centre, and if abnormalities are identified, offer cryotherapy immediately. In my words, “Not to follow The Hindu’s recommendations is criminal”
Furthermore, as It is unlikely that vaccination of young girls alone will have a far-reaching impact over the coming few decades, the only way to prevent deaths is to deploy the entire assembly of available screening tools as part of a national cervical cancer control programme, accessible to all women, irrespective of age, education, affordability or social status.
Dr Lynette J.Dumble, Ph D., M Sc, Founder and Director of the Global Sisterhood Network
References
1. World Health Oraganisation. Cervical cancer. March 5, 2024 https://www.who.int/news-room/fact-sheets/detail/cervical-cancer
2, The Wire. Homegrown Solution to India’s Cervical Cancer Dilemma. March 26, 2024.
https://thewire.in/health/homegrown-solution-to-indias-cervical-cancer-dilemma
3. Mehta, Kalpana, Bhanot, Nalini & Rao, V. Rukmini. Supreme Court Pulls Up Government Of India Over Licensing And Trials With “Cervical Cancer” Vaccines. Counter Currents, January 07, 2013 https://countercurrents.org/mehta070113.htm
4. Singh, Jyotsna, HPV vaccine deaths: Parliament panel indicts PATH, health officials. Down to Earth, September 03, 2013. https://www.downtoearth.org.in/news/hpv-vaccine-deaths-parliament-panel-indicts-path-health-officials-42074
5 Majumder, Kunal. The Cervical Cancer Bazaar. Tehelka, March 20, 2010. https://kunalmajumder.com/httpwww-tehelka-comstory_main44-aspfilenamene200310coverstory-asp/
6. Anand, Utkarsh. ‘Can’t penalise US NGO for violating drug trial norms’. India Express, September 18, 2015 https://indianexpress.com/article/india/india-others/cant-penalise-us-ngo-for-violating-drug-trial-norms
7. Lobato, Helen. Gardasil: Fast-Tracked and Flawed. Spinifex Press, 2017. https://www.spinifexpress.com.au/shop/p/9781742199931
8. Jackson, Irvin. [US} Gardasil Lawsuits Over Failure To Warn Doctors About HPV Vaccine Risks Cleared To Move Forward. About Lawsuits, March 28, 2024. https://www.aboutlawsuits.com/gardasil/gardasil-lawsuit-failure-to-warn-doctors/
9.Editorial. Fighting cancer: On cervical cancer vaccine for girls. The Hindu, December 24,2022.
10. Schiller, John F..and Kreimer, Aimée R. An HPV vaccine from India: broadening possibilities for cervical cancer control. The Lancet Oncology, November 07, 2023. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(23)00535-1/abstract?dgcid=raven_jbs_etoc_email
11. Editorial: Keep it wholesome: On shaping a national cervical cancer control programme. The Hindu, February 21, 2024. https://www.thehindu.com/opinion/editorial/keep-it-wholesome-on-shaping-a-national-cervical-cancer-control-programme/article67867594.ece
