Questions Raised About Purpose of HPV Vaccine Trials in India

Most likely, you believe that each vaccine is carefully evaluated and tested for safety and efficacy before being brought to market, and that such trials are conducted under the highest professional standards and ethics. Sadly, there are so many scandals littering the landscape of vaccine trials, anyone who takes the time to review them will likely end up more jaded and distraught than reassured.

A recent study published in the Journal of the Royal Society of Medicine^viii brings the issue of highly questionable vaccine trial standards to the fore yet again. It’s worth noting that the HPV vaccine was yet another fast-tracked vaccine, which has devastated the lives of thousands of young women and their families since its premature release in the US.
Back in April 2011, India called a halt to trials of the Hu­man Papilloma Virus (HPV) vac­cine Gardasil after four young girls died and 120 suffered serious adverse effects. The decision was the result of a civil society-led investigation that highlighted serious ethical violations. In India, civil society groups have long been voicing their concerns regarding the safety and efficacy of the two HPV vaccines, along with the aggressive promo­tion of the vaccines and the need to inves­tigate reported deaths and adverse events post-vaccination.
Ethics violations, such as enrolling unsuspecting patients into trials without their informed consent, seems to be more the rule than the exception when it comes to overseas drug- and vaccine trials. India in particular has seen an upsurge of clinical pharmaceutical studies, and the questionable practices employed are becoming increasingly apparent.
The halted trials were post-licensing observational studies undertaken by the Programme for Appropriate Technology in Health (PATH), a USA-based not for profit non-governmental organization funded by the Bill & Melinda Gates Foundation. According to the study in the Journal of the Royal Society of Medicine, the studies should never have been undertaken in the first place, as it would clearly be impossible to evaluate the vaccine’s safety or efficacy.
The authors write:

“Currently, PATH and the Indian government are investigating whether to implement a HPV vaccination program. PATH claims that ‘in raw numbers, India has the largest burden of cancer of the cervix of any country worldwide’ and that the two states were selected ‘based on cervical cancer disease burden […] and uptake of other vaccines being in the middle range for certain variables (e.g., immunization coverage)’.
The World Health Organization (WHO) advises that the epidemiology of the disease should be known and be of sufficient importance to justify its prioritization, and that surveillance systems should be capable of assessing the impact of a vaccine intervention following its introduction.”

The problem is, the surveillance, registration and monitoring of cancer in India is sorely lacking—especially in the two regions selected for the two trials—which means it would be impossible to deduce whether or not the vaccine can actually reduce the incidence of cervical cancer or not. So why do two trials, involving 23,000 young women, when you cannot even get any valuable—or shall we say accurate—data from it? Making matters worse, the cancer data that does exist, although spotty, shows that the incidence for cervical cancer in India is low, and has already dropped by nearly 50 percent between 1982/83 to 2004/05.
According to a report in the Medical Xpress^ix:

“[Lead researcher] Professor Pollock explained: "This trial has clearly raised serious concerns for the people and government of India. The aim of our study was to look at whether data on cervical cancer in the country justify the introduction of HPV vaccination.
"We found that current data on cervical cancer incidence do not support PATH's claim that India has a large burden of cervical cancer or its decision to roll out the vaccine program. The lack of information is important because it means that World Health Organization criteria for monitoring the effectiveness of the vaccine cannot be fulfilled. Neither the epidemiological evidence nor current cancer surveillance systems justify the general rollout of an HPV vaccination program in India or in the two states where PATH was conducting its research."
Professor Pollock continued: "It's important to compare the burden of cervical cancer in India to other major health concerns, such as primary care, malaria, maternal anemia and malnutrition, and consider best use of financial resources. HPV vaccine, which is among the most expensive vaccines on the market, is not justified as a health care priority for India."
http://articles.mercola.com/sites/articles/archive/2012/07/07/pandemic-swine-flu-vaccines.aspx?e_cid=20120707_DNL_artNew_1