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Published On: Sat, Nov 25th, 2017

Fallacious cost-benefit analysis from PGI Chandigarh used to promote HPV vaccine

nsnbc : A fallacious and misleading health –economic evaluation published by the Post Graduate Institute of Medical Education and Research, (PGI) Chandigarh, India has been challenged in the journal Cancer, notes Jacob Puliyel MD, a member of the National Technical Advisory Group on Immunization Government of India. Puliyel stressed that this is perhaps the first vaccine to be introduced to the general public with no proof that it works.

Photo courtesy Baker-13333

Photo courtesy Baker-13333

Dr. Jacob Puliyel stresses that the vaccine has been introduced in Punjab, India, after the PGI evaluation, even though it is not approved by the National Technical Advisory Group on Immunization.

The vaccine in question has previously drawn international attention when it transpired that it was associated with deaths of tribal girls in Andhra Pradesh, in a clinical trial performed without their consent by PATH of the Bill and Melinda Gates Foundation.

Dr. Puliyel draws attention to the fact that the journal Cancer has now fast-tracked and published an article that points out that the author’s evaluation was grossly erroneous, as it wrongly assumed that mortality in cervical cancer was 98 to 99%. This falsely exaggerated the benefit of vaccination.

More damagingly, notes Puliyel, the letter points out that the authors not only present a faulty model – “they also distort the science published by others”.

The PGI authors claim that a paper by the Harvard School of Public Health has reported that, “Only if the price of the vaccine is considered as high as US$100 per dose, the cost per DALY averted generally exceeds the cost-effectiveness threshold of the respective countries.”

The Harvard article, on the other hand, reports that the vaccine is not cost-effective if it costs more than US$ $3.30 per child. The PGI paper was published in the prestigious journal Cancer and claimed that the HPV vaccine was cost-effective in India even if it were to cost the US $ 14 (Rs 900) per girl child vaccinated.

Dr. Puliyel stressed that “It remains to be seen how the Post Graduate Institute of Medical Education and Research (PGI) will react to this revelation about their researchers’ work.

Puliyel reiterated that Human Papilloma Virus (HPV) infection is a sexually transmitted disease much like syphilis. Some strains of HPV may cause cervical cancer (cancer of the lower part of the uterus) many years after the infection. A vaccine was developed some 10 years back that can prevent infection with some strains of HPV.

However, notes Puliyel, there are as yet no studies showing that the vaccine prevents cancer as this take decades to develop and the vaccine is only about 10 years old. He also stressed that “this is perhaps the first vaccine to be introduced to the general public with no proof that it works”. He also underpinned that use of the vaccine in adolescents has been associated with serious adverse events that it has been withdrawn from the Japan immunization programme.

The vaccine is very expensive and a study done by the International Health Policy Program, Thailand found HPV vaccine was not a cost-effective policy choice. Health economic analysis done for India by the Harvard School of Public health found that if the cost for fully vaccinating a girl exceeds $3.30 (Rs 200 approximately), it is less cost-efficient than screening alone.

Dr. Puliyel reiterated that the HPV vaccine was the vaccine used in the unethical trial by PATH  of the Bill and Melinda Gates Foundation and Indian Council Medical Research (ICMR) funded by Merck Sharp and Dohme (MSD) and Glaxo SmithKline (GSK) – the vaccine manufacturers, in Andhra  Pradesh.

The 72nd report by the Parliamentary Standing Committee castigated the Indian Council Medical Research, Drug Controller General of India, Ethics Committee members, and PATH for the unethical manner in which this clinical trial was done after calling it a demonstration project.

Moreover, the American College of Pediatricians has published the following ‘New Concerns’: “It has come to the attention of the College that one of the HPV vaccines could possibly be associated with the very rare but serious condition of premature ovarian failure (POF), also known as premature menopause.

Jacob Puliyel – nsnbc 25.11.2017    –    Jacob Puliyel MD is a member of the National Technical Advisory Group on Immunization Government of India. He can be contacted by email at puliyel(at)gmail.com – or by phone at 09868035091.

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