By Kamal Pratap Singh, Managing Editor, Biotech Express E-mail- kamal9871@gmail.com
Recently, the media was full of rumors about Poonam Pandey’s death from Cervical cancer but later turned out that the news was fake and was a stunt pulled off by the actor and her team to spread “critical awareness” about cervical cancer.
Since this is a bioscience magazine, here we will see how glamour and media come together while planning advertisements and promotions which target people to sell the drugs. This is not the first time when a fake death has been used as a weapon to sell VACCINE. If you follow USA and European science news networks then you must know what recent news are coming and how unproved vaccines were inoculated to the whole world when the infection rate and mortality rate were less than 1%. Now people are blaming COVID vaccines for various side effects including mortality.
So let us know about the Cervical cancer first (see box1) and subsequently we will get to know about Poonam Pandey, HPV Vaccines and their manufacturers, controversies around available HPV vaccines, Govt. response and how to go ahead to prevent cervical cancer.
Who is infamous Poonam Pandey?
The Wikipedia introduces Poonam Pandey as an Indian model and an erotic actress. She became popular through her social media accounts, including Twitter when she started posting her semi-nude photos. Poonam Pandey rose to media spotlight when she promised to strip for the India national cricket team if it won the 2011 Cricket World Cup. India indeed lifted the World Cup; She wanted to fulfill her promise however, could not due to public disapproval and later she claimed she was denied permission by the Board of Control for Cricket in India (BCCI).
Desperate to nude, in 2012, ultimately she posed nude after Kolkata Knight Riders won the Indian Premier League. In another instance, Poonam Pandey had been booked for shooting a vulgar video at the Chapoli dam in Canacona village in Goa. The complaint was filed by the state Water Resources department which manages the dam.
Not only professionally she has been accused of using her personal life for publicity stunt. Many accused Poonam Pandey of scamming and abusing the use of IPC Section 498A, which is for domestic abuse, as she suddenly patched up with her husband, just a few days after the incident. She was also trolled on social media calling the whole incident – a mere publicity stunt. Poonam Pandey’s filmography reads like a collection of C grade semi-porn films – from her debut film Nasha to more shady outings like Love Is Poison, Love in a Taxi etc.
Staging Fake death
What is not told in the last section is about the recent publicity stunt of Poonam Pandey which seems little awkward because it is not clear from the facts that why she did it and if it was done at a perfect timing to give advantage to pharma companies who make cervical cancer vaccines. Indeed this is a reason why this article has been written, so that people can make more informed decision before injecting anything in their bodies.
Poonam Pandey’s manager conveyed on her official Instagram account through a post that Pandey had died of cervical cancer on 1 February 2024, at the age of 32. But suddenly she came out from the grave and wrote on social media that she is alive. It was announced to be a publicity stunt to raise awareness about the cervical cancer, which received widespread criticism.
Pandey publicly apologized after the All Indian Cine Workers Association demanded that the Mumbai Police Commissioner file an FIR against her. She is facing Rs 100 crores defamation Law suit by Faizan Ansari who has filled a case against Poonam Pandey, accusing her of tampering with the sentiments and trust of millions of people.
Who gets benefits?
So far we have seen that Poonam Pandey is not a celebrity who is trustworthy but the only advantage she has that she is a woman and a perfect candidate for advertising a women’s product which is a vaccine here.
There are two things that coincide with Poonam Pandey’s publicity stunt. First, readily available India’s indigenous HPV vaccine for cervical cancer made by Serum Institute of India and announcement by India’s finance minister in the interim budget 2024, that the government would “encourage” vaccinating girls aged 9 to 14 years, against cervical cancer.
There is another angle came out when more research was done while writing this article. It involves MSD, maker of Gardasil which announced that though they were involved with the agency that fabricated this publicity stunt, they have nothing to do with this. Calling the latest activity “grossly irresponsible and distasteful,” MSD wrote- we terminate our service contract with the agency.
Schbang, the digital agency that masterminded the cervical awareness campaign in collaboration with Poonam Pandey and Hauterfly, revealed on LinkedIn that the entire campaign was a pro-bono and not-for-profit campaign that was undertaken entirely to spread awareness and create at least a 1000 headlines on the subject of cervical cancer (but why and who sponsored this). They also claimed that the actress had a personal stake in the affair as her own mother once battled the disease.
Available HPV Vaccines against Cervical Cancer
There is no cure for Cervical Cancer once it is established. Having said this it is important to note that many studies have concluded that though there is no cure but Cervical cancer can be prevented by vaccination against HPV and other measures(discussed later).
Since there are handful companies that manufacture HPV cervical cancer vaccines the competition is very very tough and thus we can understand why the Poonam Pandey death stunt was followed.
Also it is important to point out here that each vaccine that is available in India has surrounded around controversies that cannot be ignored while thinking about inoculation of large population by schemes like UIP that has been recommended by National Technical Advisory Group on Immunization (NTAGI). We will get back to controversies in separate section, let see what is available in Indian market and for how much.
Two companies were making cervical cancer vaccines in India before the entry of Serum Institute of India’s (SII) made-in-India vaccine CERVAVAC.
British pharmaceutical major GlaxoSmithKline’s (GSK) Cervarix has shown to prevent infection from HPV types 16 and 18 and some cross-reactive protection against HPV virus strains 45 and 31 in clinical trials. Its two doses are indicated 6-12 months apart. Each dose of this vaccine costs Rs 2,200-2,600.
MSD Pharmaceuticals Pvt Ltd, a wholly-owned subsidiary of Merck Sharp and Dohme (known as Merck and Co, Inc in the US and Canada) is making Gardasil 4 (quadrivalent vaccine) in India, Gardasil 4, which was first launched in India in 2009, works against HPV types 16 and 18. But it also works against types 6 and 11. Each dose of 2- or 3-dose schedule Gardasil 4 costs Rs 3,500-4,000. Another version of this vaccine, Gardasil 9 or Gardasil Nano, is effective against nine strains of HPV — types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Each dose of 2- or 3-dose schedule Gardasil 9 costs Rs 9,000-10,000.
Cecolin, a vaccine made by Chinese company is available in few countries but not available in India.
Cervavac, an indigenous cervical cancer vaccine developed by SII, has been available in India since last year. This is a quadrivalent vaccine, meaning that it is effective against four HPV types — 6, 11, 16 & 18. It is a 2-3- schedule dose and each dose of this vaccine costs Rs 2,000. The Serum Institute of India is the latest entrant in the segment.
Cervavac is developed and manufactured by the Pune-based Serum Institute of India (SII) in partnership with the Department of Biotechnology (DBT), Ministry of Science and Technology, along with the Bill and Melinda Gates Foundation. SII had started phase 2 and 3 clinical trials in multiple centres across India to study the efficacy of the vaccine in young women in 2018. On July 12, 2022, the Drugs Controller General of India (DCGI) granted market authorisation to (SII) to manufacture the HPV vaccine.
Controversies Around Available Cervical Cancer Vaccines
HPV vaccines Gardasil and Cervarix have been controversial in India since 2009, when a clinical trial conducted by the American non-profit PATH and sponsored by the Bill & Melinda Gates Foundation (BMGF), in partnership with the Andhra Pradesh and Gujarat governments, led to the death of eight girls and all the seven deaths were summarily dismissed as unrelated to vaccinations without in-depth investigations.
Around 24,000 pre-adolescent girls were given Gardasil and Cervarix in the trial, overseen by the Indian Council of Medical Research and the Drug Controller General of India. But later, it was found that the agencies and companies involved had violated research ethics by giving the girls the vaccine without informed consent from their parents, as highlighted in a parliamentary committee report in 2013.
The Committee found the entire matter very intriguing and fishy, it was clear that the main objective of PATH project was to generate evidence that would facilitate the introduction of HPV vaccine Gardasil into government-funded immunization program in India. The standing committee report was a shocker but it became even more significant when it was mentioned that the study was sponsored by the Bill & Melinda Gates Foundation (BMGF).
The Committee highlighted the observations of the experts of the enquiry Committee who have opined that the design o f the PATH project itself was FAULTY. For instance, in the documents there was no column whatsoever for Serious Adverse Events (SAE) and no diary was to be maintained as part of the protocol. Moreover, much before the trials started, many expected side effects including anaphylaxis (severe allergic reaction), syncope, convulsions, asthma, central demyelinating diseases, acute disseminated encephalomyelitis, Idiopathic Thrombopenia Purpura, etc. were known.
The Committee was unable to understand as to how ICMR could commit itself to support “the use of the HPV vaccine” in an MOU signed in the year 2007 even before the vaccine was approved for use in the country, which actually happened in 2008. The Committee also questions the decision of ICMR to commit itself to promote the drug for inclusion in the Universal Immunization Programme (UIP) even before any independent study about its utility and rationale of inclusion in UIP was undertaken.
The Committee feels that there was serious dereliction of duty by many of the Institutions and individuals involved. The Committee observes that ICMR representatives, instead of ensuring highest levels of ethical standards in research studies, apparently acted at the behest of the PATH in promoting the interests of manufacturers of the HPV Vaccine. The Committee’s examination has proved that DCGI has also played a very questionable role in the entire matter.
In 2017, Swadeshi Jagran Manch (SJM), an affiliate of the Rashtriya Swayamsevak Sangh, had written a strongly worded report to Prime Minister Narendra Modi against any efforts to introduce the HPV vaccines in the UIP, saying the project was being pushed by agencies with “vested interest”. Ashwani Mahajan, national co-convener of SJM, said the group still has the same stand. “If there is a move to consider the vaccines against cervical cancer — even the one made in India — in the UIP, we will fiercely oppose it,” he said.
Controversies in Indian Counterpart – SII’s Cervevac
Union Minister of Science and Technology Dr Jitendra Singh, on September 1, 2022, announced the scientific completion of India’s first indigenously made Quadrivalent Human Papillomavirus vaccine (qHPV), Cervavac two months prior any official statements from the govt. department or company. And DCGI has given market permission to SII for cervevac much before (July 12, 2022) it published results in public domain for scrutiny (published in December 2023). When analyzed some conflicts came out from research article that was published to showcase results of clinical trials of Cervevac. These documents are backbone behind gaining trust among public and market authorization …
The CDSCO document dated December 31, 2022 reads…
The safety profile presented below is based on data from clinical trial (SII-qHPV/IN-02) conducted in India where CERVAVAC® was administered to 1530 study participants aged 9 through 26 years.
CERVAVAC® is indicated in girls and women 9 through 26 years of age.
CERVAVAC® is for prophylactic use only and has no effect on active HPV infections or established clinical disease. This vaccine is not intended to be used for treatment of active external genital lesions; cervical, vulvar, or vaginal cancers.
The minimum anti-HPV titer that confers protective efficacy has not been established.
The phase 2/3 study of clinical trial was published in The Lancet Oncology document in December 2023. (https://pubmed.ncbi.nlm.nih.gov/37949086/)
Upon ananalyzing both CDSCO document and The Lancet Oncology research paper, following observations were made-
1. CERVAVAC® is for prophylactic use only and has no effect on active HPV infections or established clinical disease.
2. Number of enrollments are different in CDSCO and The Lancet Oncology.
3. Sample size is very small for considering inoculation of world’s largest population.
SIIPL’s vaccine and the comparator vaccine contain the same HPV types in similar concentration and it was immunobridging approach. This study compared vaccine efficacy with Gardasil 4 but Gardasil 4 has numerous reported serious side effects for which the manufacturer has paid compensations to the victims.
4. Women aged 15–26 years were chosen as the comparator group because the efficacy of the comparator quadrivalent HPV vaccine (Gardasil 4) in this age group has already been established but nothing has been specified about the efficacy of the comparator quadrivalent HPV vaccine (Gardasil 4) in 9-14 age group.
5. No comparison could be established between CERVAVAC and Gardasil 4 in Boys or men because they could not receive the comparator since it is not yet licensed for males in India.
6. The study has not yet completed, participants recruited in phases 2 and 3 will be followed up for 3 years from the first dose of the vaccine to assess long-term immunogenicity and safety.
7. No data on race or ethnicity, socioeconomic status, or education were collected, which compel us to think that the participants were educated enough to take informed decision about their health.
8. Though it is mentioned that 36 (3%) of 1107 participants reported a medical history finding at screening in the aged 9–14 years cohort but the condition of medical history not mentioned.
9. Ten grade 3 unsolicited adverse events were reported, which included an event each of pyrexia, ureterolithiasis, humerus fracture, radius fracture, and events of typhoid fever (reported in two participants), and four events of dengue fever.
Government Response
During series of events, in June 2022, the National Technical Advisory Group on Immunization recommended the introduction of HPV vaccine in the universal immunisation with “a one-time catch-up for 9-14 year-old adolescent girls followed with routine introduction at nine years”, the Rajya Sabha was told in March 2023.
Multiple media outlets reported in second week of January, 2024 that the central government is likely to roll out an immunisation campaign against human papillomavirus (HPV) later this year. The government, however, on 13 JAN 2024 came up with a clarification and dismissed those reports as “false and speculative”.
Although not hinted about inclusion of HPV vaccine in UIP, once again Union Minister Nirmala Sitharaman in her interim budget 2024 speech emphasized that the government will encourage vaccination of girls in the age group of 9-14 years to prevent cervical cancer.
And that is when suddenly media rumors about Poonam Pandey death appeared. Actor Poonam Pandey is not being considered as the brand ambassador of the government’s national campaign to spread awareness on cervical cancer, Union health ministry officials said on Wednesday. The clarification came after sources said Pandey is likely to be the face of the campaign and she and her team are in talks with ministry officials.
But officials now maintain that the plan stays shelved. “It’s mainly due to reasons related to funds and concern around side-effects related to the vaccine,” said an official in the vaccine division of the health ministry, to The Print on February 8, 2024.
How to reduce risks of Cervical Cancer?
Cervical cancer screening at regular intervals is one of the top strategies for women who want to take care of their health. The Pap test (or Pap smear) and the human papillomavirus (HPV) test are specific tests used during screening for cervical cancer. The latest recommendations from the American Cancer Society (ACS) list a preference for HPV testing alone every five years for women ages 25 to 65. If that screening option isn’t available, the ACS recommends that women get a combined HPV/Pap test every five years or a Pap test every three years.
Reduce your risk of cervical cancer by taking measures to prevent HPV and other sexually transmitted infections by limiting the number of sexual partners you have and using a condom every time you have sex.
Conclusion
In this article we have seen that there are only three vaccines available for cervical cancer but none of them can cure the disease, they are for Prophylactic use only. Now we have made in India vaccine but that again has some controversial issues that need to be addressed. We should not forget what has been said by inquiry committee after the investigation of clinical trials of Gardasil 4 and cervarix and this hold true for any drug or vaccine that has not gone under strict regulatory procedure. The quote says- Had PATH been successful in getting the HPV vaccine included in the universal immunization programme of the concerned countries, this would have generated windfall profit for the manufacturer(s) by way of automatic sale, year after year, without any promotional or marketing expenses. It is well known that once introduced into the immunization programme it becomes politically impossible to stop any vaccination.
Disclaimer: The writer has tried his best to assess information and present them here. The writer does not suggest any medical treatment or hurt any religious sentiments.
