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Why glitz and glamour around HPV vaccine when cervical cancer is on a declining trend

By Dr Amitav Banerjee, MD* 

Few days ago, a struggling starlet and model, Poonam Pandey, had her one minute of fame. The news of her death from cervical cancer at the young age of 32 years was shocking. Couple of days later she rose like a phoenix from "death" creating a sensation. Was there a method in this madness?
According to her she enacted this drama for a noble cause -- to draw attention to cervical cancer which affects a large number or women in the country. Her stunt was similar to the mother coaxing her child to go to sleep else "Gabbar" the dacoit will come to borrow the phrase from the popular Hindi movie Sholay. "Beta so ja nahin to Gabbar aa jayega!" She perhaps wanted to shock all girls into taking the Human Papilloma Virus (HPV) vaccine else they may die from cervical cancer. “Vaccine le le, nahin to ‘Cervical Cancer' aa jayega!"
For many this frivolity left a bad taste in the mouth. Was it a coincidence that a day before the news of her death, on 01 February 2024 the Union Budget announced its intention to push for preventive vaccination against cervical cancer for girls aged 9 to 14 years?
Keep in mind that the average age of getting cervical cancer is 50 years, about 4 decades later. Will the promise of the vaccine to prevent cervical cancer hold good 4 decades down the line? These are some serious questions which cannot be wished away by frivolous stunts. We need solid evidence. Propaganda is short-lived and often backfires. What is the current evidence?
Nobody knows for sure but the concept of prevention by vaccination is based on the fact that one of the causes for cervical cancer is the HPV virus which has over 200 types. Types 16 and 18 have been associated with precancerous lesions of cervical cancer, while types 6 & 11 are associated with genital warts.
The natural history of these precancerous lesions does not follow a straight path. The majority of these lesions are self limiting and clear without treatment. Therefore using these proxy markers instead of the main outcome, i.e. cervical cancer can overestimate the efficacy of the HPV vaccines. 
Most trials have followed up the vaccine recipients for less than a decade using surrogate markers such as clearance of HPV virus and antibody response. All these endpoints are a poor substitute for predicting cervical cancer decades later.
Another limitation is that the measure of efficacy of most HPV vaccine trials has been the relative risk instead of the attributable risk which depends on the prevalence of HPV virus infection in a particular population which has shown wide variations from 2% to 50%, being highest in commercial sex workers and people with HIV/AIDS.
For a detailed critique of the available evidence one should refer to a peer reviewed paper by Rees and colleagues in the prestigious Journal of the Royal Society of Medicine, titled, "Will HPV vaccination prevent cervical cancer?" The authors conclude there is great uncertainty whether the vaccine prevents cervical cancer.
Another disconcerting feature of the HPV virus is that it has 200 types and vaccine covers only 4 types. We do not know whether vaccine pressure can cause other strains not covered by the vaccine to become dominant becoming a risk for cervical cancer.
Because of these uncertainties, even the manufacturers of the vaccines recommend that even after taking the HPV vaccine women should keep undergoing periodic screening with PAP smear for early detection of cervical cancer. Does it ring a bell? Remember, the recommendations to keep wearing a mask and follow "Covid Appropriate Behaviour" even after taking the Covid-19 vaccine!
We really do need more serious scientists doing serious research to resolve these issues instead of film stars and public figures including "celebrity doctors" promoting vaccines in the manner of advertisements for fast foods.
Fast foods have their downside leading to obesity and a number of chronic diseases. Similarly vaccines promoted like fast foods without careful research can have its downside. Some efforts are required to promote good health including safe sex to prevent cervical cancer.
HPV virus is sexually transmitted just like other sexually transmitted diseases such as syphilis, gonorrhoea, HIV/AIDS, Hepatitis B, Hepatitis C and others. The risk factors for HPV infection and cervical cancers are multiple sex partners, unprotected sex, poor genital hygiene and repeated pregnancies. 
Union Budget pushed for HPV vaccine for girls aged 9 to 14 years when average age of getting cervical cancer is 50 years
A holistic approach to prevent all sexually transmitted diseases including HPV infection would be to educate young boys and girls about responsible and safe sexual behaviour during their lifetime. Would getting a HPV vaccine protect against HIV for which there is no vaccine? One can use these scientific information to stress among the youth the need for responsible sexual behaviour.
A recent paper shows that the trend of cervical cancer is declining in India for the past three decades. The AIDS pandemic during this period is likely to have created awareness about safe sex in addition to better living standards including genital hygiene all adding up to the steep fall in cervical cancer in many states of India.
Shouldn't we wait and watch the declining trend further instead of including the HPV vaccine in the UIP in midst of so many uncertainties? Or do we by pushing mass vaccination muddy the waters which will destroy all evidence by elimination of the control group which is essential to establish the efficacy or harm, if any, of the HPV vaccine.
The latter assumes significance in view of the chequered history of the HPV trials in India. The Bill and Melinda Gates Foundation through its Program for Appropriate Technology in Health (PATH) conducted trials among vulnerable tribal girls in Andhra Pradesh and Gujarat from 2009 to 2010. 
To bypass ethical issues the investigators labelled the trials as observational instead of a clinical trial. During the trial a few girls died due to the HPV vaccine. The girls were residents of a government hostel for tribal children. The investigators including scientists from the ICMR denied that the deaths were due to the vaccine.
As a result of public outcry, the trial was halted. The tragedy was investigated by a Joint Parliamentary Committee. The Committee tabled its 72nd Report titled, "Alleged irregularities in the conduct of studies using human papilloma virus vaccine (HPV) vaccine" to both houses of parliament on August 30, 2013.
The committee found many major irregularities and indicted the Gates Foundation and the ICMR and the researchers for dereliction of duty.
Unfortunately, pubic memory seems to be short. Professionals like doctors promoting the vaccine unconditionally also seem to be unaware of the uncertain evidence of efficacy and the botched up trials leading to deaths of vulnerable tribal girls. Glitz and glamour of high pressure marketing is poised to brush these uncomfortable truths under the carpet.
---
*Renowned epidemiologist, professor at DY Patil Medical College, Pune. Having served as an epidemiologist in the armed forces for over two decades, he recently ranked in Stanford University’s list of the world’s top 2% scientists. He has penned the book, “Covid-19 Pandemic: A Third Eye”

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