� � Sep-25-2008
The raging debate in the medical circles in the United States, Canada as well as Europe currently is whether the girls should be immunized against the effects of the human papilloma viruses (HPV). Incidentally, the human papilloma viruses are known to be the basis of the cancer of cervix (relating to the womb). In fact, a great number of health authorities in these countries are in favor of extensive inoculation with Gardasil - known to be the first permitted anti-cancer or cancer combating vaccine. On the other hand, there are many others who have suggested adopting a slower pace in this regard and want to evaluate the vaccine's long-term consequences first.
It may be mentioned here that the Gardasil vaccine safeguards the body from four kinds of human papilloma viruses (HPV) that are passed on through sexual activities and leads to the growth of lumps or warts in the genital organs. It has been found that this in turn may perhaps bring about harmful changes in the cells of the cervix. Studies have further demonstrated that types 16 and 18 of the human papilloma viruses are accountable for approximately 70 per cent of pre-cancerous wounds (especially where the skin is infected or broken), anomalous growths and cancer of the cervix. On the other hand, types 6 and 11 of the HPV lead to the development of approximately 90 per cent of the lumps or warts in the genital organs.
Health authorities in the United States, Canada and European countries have permitted the use of Gardasil vaccine among girls and women between the age group of 9 and 26 years. Studies have shown that once they are immunized with Gardasil, girls and women are safe from the cervical cancer for a period of up to four years. Meanwhile, Merck, the manufacturer of the Gardasil vaccine, is now conducting post-approval researches under the directives of the United States Food and Drug Association (FDA) to ascertain whether the vaccine needs to be made more potent to make them effective for a longer period of time. A decision in this regard is still awaited.
Although the health authorities in the United States, Canada and many European nations are actively considering immunizing girls and women between the age of 9 and 26 years with Gardasil vaccination to protect them against cancer of the cervix, researches have shown that the booster has only limited applications. In fact, the Gardasil vaccine have been found to be effective only against types 6, 11, 16 and 18 human papilloma viruses (HPV), but is of no use against all other HPV types, which are accountable for approximately 30 per cent cases of cervical cancer and about 10 per cent cases of genital warts. Moreover, Gardasil vaccine does not safeguard a person from infections transmitted through sexual activities or heal any contagions caused by human papilloma viruses. However, researchers claim that they have some evidence that suggests that Gardasil vaccine is able to alleviate extra pre-cancerous growth and prevent it from expanding. In fact, health authorities in all these countries have stressed on the need for regular pelvic tests and check for cervical cancer even after being immunized with Gardasil.
Meanwhile, detractors have disputed Merck's claim regarding the efficiency and safety of Gardasil vaccine. The detractors have accused the claims to be biases stating that the studies quoted by the company to provide evidence of the vaccine's effectiveness and protection have been financed by Merck itself. In fact, they have pointed out that none of the studies have been conducted by an independent agency.
It is unfortunate that the detractors or critics who have been disputing the claims of Merck for its role in financing, planning and undertaking the studies that eventually led to the approval of Gardasil are actually demonstrating their hostility towards the pharmaceutical company for abiding by the norms and policies of the United States Food and Drug Association (FDA) as well as other parallel authoritarian bodies in Canada and the European nations. The fact is that Gardasil not only underwent several vigorous tests and clinical experiments before being granted permission for use in the US and Canada, but the operations that preceded the vaccine were conducted by researchers at the US National Institutes of Health (NIH), Merck laboratories, Georgetown University, the University of Rochester in New York and the Queensland University in Brisbane in Australia.
It is interesting to note that the first laboratory researches that resulted in the manufacture of Gardasil actually began way back in 1991. It took 15 years for the vaccine to get approval from the health authorities in the United States, Canada and European countries. The vaccine was granted permission for use on humans in 2006 following 10 pre-clinical researches and 12 clinical studies. Moreover, the effectiveness of the vaccine was evaluated in four placebo-controlled, double blind, unsystematic or randomized Phase II and Phase III medical researches. In fact, the four clinical experiments were conducted at an international level for a period covering two or more years. During this period researchers assessed the impact of the vaccine in over 20,000 women in the age group between 16 and 26 years with follow-up periods of two to four years.
All the concerned regulatory bodies, including the United States National Institutes for Health (NIH), FDA as well as Health Canada have certified Gardasil to be exceedingly effectual in averting unrelenting contagions that bring about pre-cancerous changes in the cervical cells. Even independent researches conducted later have authenticated Merck's claims regarding the efficiency and protection of Gardasil.
Any endeavor to protect children from the pangs of deadly cancer is praiseworthy. And considering the intensive and exceedingly infectious disposition of human papilloma viruses (HPVs), it is likely that many girls who become sexually active from an early age are susceptible to being affected by HPV. All said and done, the question still remains that what is the real possibility of a girl developing cancer of the cervix from HPV.
It has been found during researches that while the human papilloma viruses (HPVs) are accountable for all cases of cancer of the cervix, but not all girls or women who have been infected by HPV develop cervical cancer. Although it is a fact that all over the world cancer of cervix is key eradicator, the fact remains that the reports of deaths from the developing nations owing to cervical cancer seem to be highly distorted or biased. A close scrutiny of the mortality statistics owing to cervical cancer reveals that the figures have been exaggerated basically owing to the absence of adequate screening of the patients as well as their healing.
Instances of cancer of the cervix are comparatively at a low level in the industrialized or developed nations where good sanitation, awareness on safe sex, early screening of the disease and adequate medical care are easily available. Reports of death owing to cervical cancer are even uncommon in these countries. For instance, in 2004, 11,800 cases of cervical cancer were detected in the United States signifying the prevalence of the disease in 7.9 people per 100,000. The death rate owing to the disorder was even less accounting for a mere 2.6 casualties per 100,000 people. On the other hand, 186,772 cases of breast cancer were reported across the United States in the same year. Among these patients, the death rate was approximately 27.5 persons per 100,000. Incidentally, the statistics for these diseases are almost similar in other nations like Canada, Europe and Japan.
It is an irony that when deciding whether to immunize their daughter with Gardasil, parents will now have to confront some unpleasant, unwarranted as well as embarrassing questions. They will have to find out when their daughter will become sexually active, the number of sex partners she might have and what if one of these partners are carriers of human papilloma virus (HPV)! What will happen if their daughter is exposed and contacts HPV that might lead to the cancer of the cervix? Would it be wise to immunize their daughter with Gardasil that would protect her from the contagion called HPV? In brief, parents in the United States, Canada and the European nations have been put at crossroads by asking them to maintain equilibrium between the hazards of their daughters being exposed to cancer owing to the girls' unsafe sexual activities in future and the menace of being treated with the new vaccine named Gardasil.
Nonetheless, the good thing is that the younger the girl is, the more time parents will have at their disposal to assess the advantages and disadvantages of human papilloma virus (HPV) immunization. In fact, it would be much easy to take a decision on the HPV vaccination if there is any instance of cervical or vulvar (female external genital organ) cancers in the family history. All said and done, the manufacture of the breakthrough Gardasil vaccine has definitely made parenting more tricky and complex.