COLUMN/ THE WRITE LINE
Dr. Amitav Banerjee
January 23, 2023: Cervical cancer, which has been in the news of late, is associated with poor genital hygiene, early age of marriage, repeated pregnancies, and multiple sexual partners. The human papillomavirus or HPV is supposed to contribute to precancerous lesions which may progress to cancer.
The majority of HPV infections are asymptomatic and resolve spontaneously. The prevalence of HPV infection in countries varies – ranging from 2% to 42%. Women living with AIDS have a much higher prevalence, around 54%.
Through genome sequencing, 200 HPV types have so far been identified. Among them, Type 16 HPV is supposed to pose the highest risk of cancer cervix, followed by Type 18. The strategy of preventing cancer of the cervix through HPV vaccination is based on this premise. Vaccination of pre-adolescence girls before onset of sexual activity is recommended.
Two vaccines against HPVs, Gardasil 9 (Merck) and Cervarix (GSK), have been available since 2006. Both contain proteins to elicit antibody response against HPV 16 and 18 genotypes, which together are known to cause 70% of cases of cervical cancer globally. Gardasil 9 also includes proteins to confer protection against HPV Types 6 and 11, which has been poorly associated with cervical cancer, but may cause genital warts.
DISTURBING PAST
German playwright Bertolt Brecht once famously said, “First comes a full stomach, and then comes ethics.” Social, cultural, and economic contexts dictate the level of empowerment of the public. It is often easy to breach ethical principles in research where people have low levels of empowerment. HPV vaccine trials among adolescent tribal girls, undertaken in a low-key manner in India, is one such instance.
The Program for Appropriate Technology in Health (PATH), an American agency backed by Bill and Melinda Gates Foundation (BMGF), conducted the trials in Andhra Pradesh and Gujarat from July 2009 to October 2010. PATH described it as an observational study instead of a formal clinical trial presumably to circumvent thorny ethical issues.
During the trial, a few girls died after receiving the vaccine. None of the girls reportedly had any prior illnesses. All were residents of a government-run hostel for tribal children. Stakeholders claimed that the deaths were unrelated to the impact of the jabs. But still, there was an outcry.
The central government eventually halted the trial. The ICMR reportedly insisted that the deaths were coincidental and happened due to “extraneous reasons”. But people were not convinced and demanded an independent enquiry, even as the state government said the girls committed suicide.
This was denied by the parents of the victims and not properly supported by circumstantial evidence collected by an NGO working with the tribal community as some of the girls who received the vaccine reportedly experienced symptoms such as epileptic fits, mood swings, and severe stomach illness.
The tragedy was investigated by the Parliamentary Standing Committee on Health and Family Welfare. It submitted the 72nd Report – Alleged Irregularities in the Conduct of studies using human papilloma virus vaccine (HPV) by PATH in India – to both houses of Parliament on August 30, 2013.
The Parliamentary Committee found that ICMR had signed an MoU with PATH in 2006 to support the trials before the Drug Controller General of India (DCGI) had approved the vaccine. The committee indicted several institutions and individuals of “dereliction of duty”. It also questioned the ICMR’s role in trying to promote the inclusion of the vaccine in the Universal Immunisation Programme (UIP) before any independent study about its efficacy.
The committee noted that all seven deaths were dismissed as “unrelated to vaccinations without in-depth investigations”. According to the inquiry committee report, the speculative causes of death were suicides, accidental drowning, malaria, viral infections, subarachnoid haemorrhage (without autopsy) etc. The committee also noted that “suicidal ideation” is caused by many drugs.
The Parliamentary Committee recommended that the matter be inquired into by a premier investigating agency. But it has almost been a decade since then. No such investigation has been carried out yet. Meanwhile, they seem to have built stronger alliances. While the MoU between the ICMR and PATH was looked at critically by the Parliamentary Committee a decade back, there seems to be scant respect for such censure.
Recently, the ICMR signed signed a Declaration of Intent (DoI) with BMGF and US-based (NIH) National Institutes of Health in research collaboration. And lobbying is underway to include the HPV vaccine in the UIP.
Well, the British ruled India by giving “sultanates” to petty Indian kings. These local satraps were effective at maintaining British rule and gained much from being loyal to the British. The British signed treaties and made military and trading alliances with many of the independent states that made up India. Today, are we witnessing the Era of Medical Imperialism where MoUs and grants for research are being offered by foreign donors as long as the recipients listen to their master’s voice?
At the individual level, prevention is cheaper than cure if one follows a healthy lifestyle, including safe sex in the context of cervical cancer. Mass vaccination without strong evidence of efficacy is not cheaper than cure. Everyone is coerced to take the vaccine while treatment is offered to a miniscule of the population who fall sick. Countries may spend a huge amount of taxpayer money on vaccines for all where only a minority may be at risk. For vaccine manufacturers, newer vaccines are like ‘Mackenna’s Gold’.
CLASS-ACTION LAWSUIT
New research has claimed that Gardasil can possibly induce and increase, in some cases, the risk of autoimmune diseases and other serious health complications, including Postural Orthostatic Tachycardia Syndrome, Neuropathy, and Fibromyalgia. Gardasil has also allegedly been linked to premature ovarian failure and infertility. However, the US CDC (Centers for Disease Control and Prevention) says on its website that “there is no relationship between Gardasil and autoimmune disorders”. The US NIH’s National Library of Medicine echoes the CDC’s view on the subject.
It is alleged that Merck could have obtained FDA approval for Gardasil in 2006 based on deceptive research and clinical trials, which seemingly misrepresented the efficacy of the vaccine while concealing its adverse effects. According to reports, some marketing campaigns for the HPV vaccine appear to have led to millions of parents opting to vaccinate their pre-teen daughters. These concerns eventually snowballed into the Gardasil Class Action Lawsuit in the US.
The latest WHO (World Health Organisation) position paper on HPV vaccines emphasises that the jab has the potential to prevent 45 million cases of cervical cancer deaths over the next 100 years. It states that 125 countries have introduced the vaccine in their national immunisation programmes. The consensus favours adoption of HPV vaccination programmes for pre-adolescents girls (and also boys in some countries), but without adequate evidence of its efficacy. The WHO and textbooks recommend it. Textbooks have in recent times come under various conflicts of interest and cannot always be trusted to give absolutely unbiased opinion.
Scientific papers without any conflicts of interest or funding from the pharma industry have expressed serious doubts about the efficacy of HPV vaccines in preventing cervical cancer. One such paper titled, ‘Will HPV vaccination prevent cervical cancer?’ by Rees et al published in the Journal of Royal Society of Medicine, critically reviews the efficacy of HPV vaccines, and concludes that there could be multiple methodological problems with the trials.
The paper summarised that the trials were “not designed to detect” protection against the outcome – cancer – which takes decades to develop. Follow-up was limited to 4-5 years. While vaccines may prevent very early pre-cancer lesions, most of these could be self-limiting. Prevention of these surrogate endpoints may not confirm the efficacy. Most trials reported relative risk, which overstates the efficacy instead of the attributable risk that is marginal.
While the jury is out, a recent paper published on BMC’s website revealed that incidence and deaths from cervical cancer over the last three decades have fallen drastically in the country, even though “it is still a major public health problem in India”.
THE EVIDENCE?
NOT ENOUGH
The existing evidence does not support the inclusion of the HPV vaccine in the national immunisation programme. It would be a wasteful expenditure of public funds with uncertain benefits. Moreover, mass vaccination could go on to eliminate the control group of unvaccinated women to resolve some of the uncertainties of the efficacy of HPV vaccines.
As cervical cancer takes decades to develop, we need to follow up both vaccinated and unvaccinated groups into their 40s and above to ascertain the benefit and harms, if any.
(Dr. Amitav Banerjee, MD, is a clinical epidemiologist, professor, and Head of Community Medicine at Dr. DY Patil Medical College, Pune. He has over two decades of experience in the Indian Armed Forces as a field epidemiologist. He led the Mobile Epidemic Investigation Team at the Armed Forces Medical College Pune from 2000-2004, when he investigated many outbreaks. He was awarded for his work on Tribal Malaria and its impact on soldiers serving in hostile terrain. This column reflects the author’s own opinions, and not necessarily those of Empire Diaries)
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