The Gardasil Vaccine - Essay Example

Must Gardasil be treated like the best advancement in healthcare or should we tread more carefully The Gardasil vaccine is the brainchild of Dr. Albert Bennet Jenson and Dr. Shin-je Ghim, researchers at the University of Louisville. Manufactured in 2006, the vaccine is marketed by Merck & Co. (which pays royalties to CSL). Many healthcare specialists are hailing this vaccine as a major advancement because it can protect against certain strains of the human papillomavirus (HPV)1, the main cause for cervical cancer cases. However, all is not rosy with the vaccine. While experts say that the vaccine shows 100% success rates both for people who have not contracted HPV infections and those who are already infected with HPV, there is also a large segment that contradicts these statements. While one side of the pharmaceutical industry argues and pushes for the drug to become mandatory, there is another side of the industry that asks the world to wait. Pros Merck & Co., a world-class pharmaceutical company that markets various vaccines, is currently marketing the Gardasil vaccine. All its products are tried, tested and accepted in the markets with a lot of confidence. Till now Merck has provided some of the best vaccines to the world. Officials state that with the growing number of cases of cervical cancer, Garadasil would dramatically improve longevity and quality of life for many. The vaccine would not only protect people from the HPV infection, but will also help the 6 million cases affected every year2. The HPV vaccine is designed to protect against strains 6, 11, 16 and 18; which together cause 90% of HPV cases (National Cancer Institute). The company is currently on an awareness program called One less and as per Bev Lybrand, vice president & general manager, HPV Franchise, GARDASIL, Merck Vaccine Division, "The full public health benefit of reducing the burden of cervical cancer and HPV disease may be achieved through broad public awareness and vaccination with GARDASIL, which is the driving force behind One Less." The US Food and Drug Administration (FDA) as of June 8, 2006 have approved Gardasil. The FDA is the agency of the US Department of Health and Human Services, responsible for ensuring the safety and efficiency of all drugs, vaccines, and medical devices. A vaccine or drug comes for FDA approval after a battery of clinical tests and phases of study. After the approval of Gardasil, Andrew C. von Eschenbach, MD, Acting Commissioner of Food and Drugs was noted to say that, 'This vaccine is a significant advance in the protection of women's health in that it strikes at the infections that are the root cause of many cervical cancers" (June 8, 2006, FDA News). Later in June, the vaccine was approved for usage on children as young as nine years old (Advisory Committee on Immunization Practices3). Cons The National Vaccine Information Center (NVIC) formed by the parents of vaccine-injured children is a leading critic of vaccines made compulsory for all people across ages. It also seriously considers the lack of research and fundamental principles that often organizations overlook. The NVIC has called upon the ACIP of CDC to inform them to refuse the universal application of Gardasil. As per them, Merck's clinical trials have not proved the vaccine to be safe for young girls. While the drug has been approved for usage in children from nine years onwards, statistics show that only a small pool of 250 pre teens were tested with Garadasil. NVIC president Barbara Loe Fisher, even went on to say that, "Merck and the FDA have not been completely honest with the people about the pre-licensure clinical trials." Many religious conservatives also do not agree with making the vaccine mandatory as they feel that it may encourage unsafe sex. Health freedom organizations are a growing force today and have been formulated to fight the political power that pharmaceutical companies leverage to sell their products in the market. Many of these organizations question the importance and viability of the vaccine which is in a very early stage. Being produced in 2006 and approved the same year, its long-term impact is still unknown. The longevity of the drug is now a topic of research and scientists are trying to study whether the vaccines will last just a few years or for much longer (National Cancer Institute). Making Gardasil mandatory may be a proposition that has come before its time. Questions also arise that whether eliminating the four dangerous strains of HPV may create space for other strains of HPV to create more havoc. Strengths and limitations for Gardasil While Merck is a company that renders quality pharmaceuticals, after Gardasil, many have blamed the company for its lobbying efforts to make the drug mandatory. Many health freedom experts feel that to increase its profits and offset the losses Merck suffered for its Vioxx drug, the company is using its political power to leverage a profitable position. After all, the vaccine could bring in a lot of profit. Being patent protected, Merck would be the sole producer of Gardasil. Estimates by analysts show that annual sales could make up to $3 billion for Merck through the life of the patent. Priced at $360 with $120 for each of the three shots, many conservative groups feel that Merck and CSL are making the drug worthy than more it is worth. The FDA has also been accused of allowing Merck to use a potentially reactive aluminium placebo rather than a saline placebo in its trials. As per the NVIC, it is a known fact that reactive placebos can make the experimental drug look safe and effective. Strengths and limitations against Gardasil NVIC and other health freedom organizations are the main critics behind the drug. Most of these groups are formed by vaccine-injured children and hence give a 'safety' perspective for every vaccine. While there is some element of truth in their statements, one must also consider that the drug has undergone clinical tests and trials and has demonstrated positive results. Moreover companies like Glaxo are testing the success of their HPV vaccine against Gardasil. A final word Given the number of people who suffer from cervical cancer, the drug has much potential and promise to improve the lives of people. With the support of FDA and ACIP, the drug is being thoroughly quality checked and marketed by a top of the line company. While many feel that the drug is important, probably it is too early to make it mandatory for school attendance (National Network for Immunization Information). Studies on its longevity and long-term impact still need to be done. Moreover, for the benefit of the community, cost cutting measures need to be implemented as much as possible. The drug must be placed in the category of an 'additional vaccine' and people must be allowed the freedom to choose whether they want to administer it or not. Reference used http://www.pbs.org/now/shows/308/hpv-facts.html http://en.wikipedia.org/wiki/Gardasil http://www.gardasil.com/who-should-receive-gardasil.html http://www.medicalnewstoday.com/medicalnews.phpnewsid=63651 http://www.womentowomen.com/sexualityandfertility/gardasil-landing.asp http://www.rxlist.com/cgi/generic/gardasil_ad.htm http://www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html http://www.redorbit.com/news/health/552025/mercks_gardasil_vaccine_not_proven_safe_for_little_girls/index.htmlsource=r_health Read More