When you visit your doctor these days you may come across a placard extolling the virtues of a vaccine that supposedly protects against cancer. This cancer affects the lower parts of the uterus in women and is known as cervical cancer. As this cancer may be caused by a virus called the Human Papilloma Virus or the HPV, the vaccine is also called the HPV vaccine.
There are actually two vaccines, the Cervarix produced by Merck and Gardasil by GSK.
When these vaccines appeared there was a flutter in the vaccine market. After all here was a vaccine against cancer!
However the situation was not at all that as the vaccine ran into heavy weather almost from the word go.
At first the objections stemmed from ethical and moral perspectives.
The HPV is acquired through sexual contact and the mothers of the girls the vaccines targeted wondered if they would encourage their wards to embrace a promiscous life emboldened by the knowledge that they were protected from a sexually transmitted illness.
Another factor was the price. When the vaccines were introduced the required three doses cost a whopping Rs. 40,000.
But as the vaccines started to be administered to young girls and women there was a sense of alarm. Deaths and adverse effects necessitating hospitalisations began to be reported from across countries where such events are recorded. The death toll in theUSalone has crossed 89 with more that 21000 cases of hospitalisations as recorded in the Vaccine Adverse Effect Reporting System (VAERS) as on Nov 23, 2010. However recording in the VAERS is passive that is, it is not compulsory. It has been observed that only 1 to 10% of cases are reported.
Sales of the vaccine dipped. The manufacturers responded by reducing the vaccines costs almost by half. Today the three doses cost Rs 9000 inIndia. But that too did not ensure a good uptake. It was also noticed that almost 73% of the population that received the vaccines did not report for the subsequent booster doses. This was attributed to the high reactogenicity of the vaccine.
The scientific community responded by describing the vaccine to be “safe and trustworthy”, a claim that the parents refused to acknowledge. The manufacturers began donating to the election funds of Presidential candidates and soon there was one who decided to mandate the vaccine for every girl child in aUSstate. There was a furore but the industry never let go of their efforts to mandate the vaccine and waive parental consent before administering the vaccine to children. They also manipulated the scientific community to declare, through proper peer reviewed and published studies, that the vaccine was also applicable to boys for, of all things, genital warts! The cancer too was not restricted to cervical cancer alone but embraced anal and even throat cancer. Though it would take over two decades to know whether the vaccine was effective, scientific studies claimed that the vaccine was a major success and that cervical cancer rates had fallen!
Critics and concerned doctors then warned the population that the claims of the manufacturers that the vaccine protected against cervical cancer was in itself doubtful as the vaccine included only two strains from a possible hundred strains of HPV that could cause cancer. They also pointed out that as nature abhors a vaccum, it was likely that targeting a few strains could make the other strains more virulent. They also warned that the vaccine contained a neurotoxic metal aluminum as adjuvant and of the presence of Polysorbate 80, an anti-fertility agent and a chemical that causes the blood brain barrier to become porus. They also warned that examination of uterus pap smears was still an effective tool for controlling cervical cancer and not the vaccine which was a long way from being proven. So even if the girls were administered all the required doses of the vaccine, they would still require to go in for regular pap smear tests to check for cancerous or otherwise caused lesions.
Subsequent studies revealed that the vaccine was contaminated with rDNA. According to researchers such rDNA was a problem even in laboratory conditions and that whenever such an entity was handled for research there were always fears that they would escape from laboratory conditions. And here was this vaccine that was injecting rDNA into childrens bodies! This itself could cause cancer besides autoimmune disorders and the vaccine package insert also stated that the vaccine was never tested for carcinogenicity! It also listed a series of extremely serious conditions including death that were observed both during clinical trials and after the vaccine was administered.
Faced with stiff opposition in developing nations the industry then turned its attention to developing nations. InIndiathe vaccine was tried on tribal girls in the states of Andhra Pradesh andGujarat. Studies of the clinical trial revealed gross irregularities as required parental consent was not taken or manipulated and doctors here protested widely and vociferously though the IAP still recommends the vaccine in its schedule. Nine tribal girls died during the trial and the trial was hurriedly stopped. Though the government claimed that the deaths were not due to the vaccine but the exact details were not made available to the public. The mothers of some of these tribal girls who could be contacted did claim that their children were hale and hearty before taking the vaccine and they blamed the vaccine for the deaths. Experiments on tribal girls inIndiais itself an unethical task.
Right now the manufacturers have devised a strategy to penetrate the developing countries.
GSK has donated 1 million doses of the vaccine to the Pink Ribbon Red Ribbon alliance and Merck has donated $ 3 million to the alliance. The idea is to draw girls and ladies to the clinic with the noble intention of conducting pap smear tests and then offer to them the vaccine. Efforts are also being made, by tweaking the scientific community again, to reduce the required doses of the vaccine and hence make it more affordable.
The European Medical Association has called for a reassessment of the vaccine in light of the contamination being found, the American Association of Physicians and Surgeons have also questioned the safety of the vaccine and so also the Scientific American, a journal devoted to science. Parents from all over the world are up against the vaccine.