Annotated Bibliography

Alfano, Christine L. Envision: Writing and Research Arguments. New York: Pearson/Longman, c2008.

Brennan, Miles. Personal interview. 05 July 2007.

In this interview, Dr. Miles Brennan talked about his perspective on the mandate of the HPV vaccine. Dr. Brennan believes that the development of the vaccine is of great scientific importance. However, there are many ways to avoid the Human Papilloma Virus and without extensive research on the HPV vaccine's possible future adverse side affects, it should not be made mandatory.

Dr. Brenna has a PHD in Biochemistry and he is a genetics professor at University of Denver. This interview was very helpful because it allowed me to personally talk to a member of the scientific community and ask specific questions about different aspects of the HPV vaccine.

Byrne, Rhonda. The Secret. NewYork: Beyond Words, 2006: 7-8.

Fox, Stuart I. Human Physiology. 9th ed. New York: McGraw-Hill, 2006. 484-487.

Chapter 15 of the Human Physiology textbook talks about the immune system and the indicated pages specifically focus on vaccine immunity. The purpose of this section of the textbook is merely educational for college-level students.

The credibility of the Human Physiology book stems from the fact that it is the required textbook for the Human Physiology course at University of Denver. This source is very informative and usefule to my research because it provides the necessary background information on vaccination and immunity.

Gardasil, Advertisement. YouTube. 2006 <http://youtube.com/watch?v=hJ8x3KR75fA> .

Harris, Gardiner. "F.D.A. Rejects Merck's New Pain Medication." The New York Times 13 Apr. 2007. 05 July 2007 http://www.nytimes.com/.

This article informs the public about the rejection of Merck's arthritis pain pill Arcoxia. This rejection was due to results form different studies showing that Arcoxia induces high risks of stroke and heart attack in patients using it. The article, also, mentions that Vioxx, another of Merck's arthritis pain pills, was withdrawn form the market in 2004 for similar reasons.

The credibility of this article stems from the fact that it was published in The New York Times. This article is concise and informative. I can use the information from this source to back up my argument that the HPV vaccine, which is also produced by Merck, should not be mandated before completion of extensive research on possible present and future side-affects.

Johnson, James William. Rhetoric: a Handbook for Writers. Belmont, Calif.: Dickenson Pub. Co., 1967.

Koutsky, Laura A., and Diane M. Harper. "Current Findings From Prophylactic HPV Vaccine Trials." Vaccine 24 (2006): s114-s121. Academic Search Premier. 05 July 2007 http://search.ebscohost.com/login.aspx?direct=true&db=aph&AN=22255838&site=ehost-live.

This article is directed towards the scientific community and describes the procedure and the results of the HPV vaccine trials. According to this article a three-dose regimen of either the bivalent or the quadrivalent HPV vaccines is "generally safe and highly effective in preventing infections and lesions caused by the targeted HPV types". The two authors, also, mention that there is ongoing vaccine safety research on pregnancy, fetal and infant outcome and such research will continue, before reaching any definite results, after the licensure and the widespread use of the vaccine.

The two authors of this article are faculty members in accredited universities. Laura A. Koutsky is a faculty member in the Department of Epidemiology of the School of Public Health in University of Washington, Seattle. Dian M. Harper is a faculty member in the Departments of Obstetrics and Gynecology and community and Family Medicine of the Norris Cotton Cancer Center of the Dartmouth Medical School. This article is very relevant and useful to my research because it reveals the medical trials that were performed, as well as, the ones that were still ongoing or had not yet started at the time of the licensure of the HPV vaccine and the mandate of it in certain states.

Lagrange, Sarah R. Vaccine Issues. New York: Nova Science, 2004. 1-17.

In chapter I of Vaccine Issues, Sarah Lagrange talks to the general public about the US vaccination policy and its issues. According to Lagrange, there are many stake-holders ranging from the Department of Health and Human Services to current and potential vaccine recipients when it comes to vaccine related issues. Thus, the production and approval of a vaccine is quite costly and involves high liability. Many Biologics companies, therefore, do not have enough incentive to produce new vaccines or to undertake the cost and effort needed to acquire FDA licensure for existing ones. I believe that the wariness of biologics companies to produce vaccines has been the reason behind the expedited FDA approval of the HPV vaccine. By the same token, the very high cost of production and approval of the HPV vaccine has been the reason behind Merck's lobbying activity in different state governments to mandate the HPV vaccine.

The credibility of this book stems from two facts. First, it is a compilation of information from different accredited resources such as the federal government. Secondly it was checked out from the Auroria library, which is an academic library. This book is very informative and very interesting in that it looks at different perspectives of vaccine issues; it has been very useful in broadening my knowledge on vaccine policies.

Melchert, Magda, and Alan List. "The Thalidomide Saga." The International Journal of Biochemistry & Cell Biology (2007). 05 July 2007 http://www.sciencedirect.com/

This article in press is directed to the scientific community and gives a review of thalidomide from its original development in the 1950's as an anti-epileptic to its present uses. In the beginning of the article, the two authors talk about 1960's use of thalidomide as an anti-emetic during pregnancy which led to “alarming” fetal defects such as phacomelia, long bone defects and cardiac and gastrointestinal anomalies. Even though thalidomide was a bad choice to be used during pregnancy, it has current uses for treating certain diseases and disorders and has potential for treating others.

The credibility of this source stems from the fact that it was published in a reputable scientific journal. The article itself is very long but the part that I'm focusing on (the anti-emetic use of thalidomide) is concise and informative. I can use this article to back up my argument that any medical drug, and especially those that the affect the reproductive organs, should not be available before extensive research on their possible side affects have been performed.

Merck and Co., Inc. "Gardasil." Food and Drug Administration Home Page. October 2006. U.S. Department of Health and Human Services. 09 July 2007. http://www.fda.gov/cber/label/hpvmer040307LB.pdf.

This resource is a comprehensive scientific report submitted by Merck to the FDA and it includes every experiment and detail on Gardasil, the HPV vaccine. In the precautions section of the report, Merck mentions that Gardasil has not been evaluated for potential in causing carcinogenicity or genotoxicity. Merck, also, mentions that the affects of Gardasil on fertility and embryonic/fetal survival have only been tested in rats.

This source is very reliable because it was posted on the FDA website as an information source on Gardasil. This source will be my primary source. I will use the lack of human data on fertility, embryonic and fetal survival and the lack of any data on carcinogenicity and genotoxicity to argue against the mandate of the HPV vaccine.

"New England Journal of Medicine Publishes New Data on GARDASIL®, Merck's Cervical Cancer Vaccine." Merck. 09 May 2007. 09 July 2007 http://www.merck.com/newsroom/press_releases/product/2007_0509_print.html.

In this press-release, Merck reveals results from the two phase III studies of its human Papilloma vaccine Gardasil, as well as, other information on the vaccine such as its efficacy and availability. According to Merck, Gardasil has very high efficacy in preventing HPV types 6, 11, 16 and 18 caused diseases in girls and women aget 9-26 who were not previously exposed to the virus. In this press-release, Merck mentions that the trial time for the vaccine was three years and that adverse side affects happened at a frequency of 1% and were mainly mild and injection-site relate. However, Merck does not mention any concerns and ongoing experiments and trials on fetal and infant outcome.

The credibility of this source stems from two facts. First, it is a press-release and secondly, it was posted on Merck's (the pharmaceutical company that produces the HPV vaccine) official website. This press-release is a good source for my research. I will use the lack of data and results on infant and fetal outcome to argue against the mandate of the HPV vaccine.

Pines, Wayne L. "A History and Perspective on Direct-to-Consumer promotion." Food and Drug Law Journal 54 (1999): 489-490. 20 July 2007 <http://www.fdli.org/pubs/Journal%20Online/54_4/art1.pdf>.

Saul, Stephanie. "Heart Attack Risk Seen in Drug for Diabetes." The New York Times 22 May 2007. 05 July 2007 http://www.nytimes.com/.

This article, which is directed to the public and the scientific community, gave an overview of an earlier article in the New England Journal of Medicine which indicated risks of heart attack involved with the diabetes drug Avandia. It, further, revealed that, according to a very recent disclosure of information, the FDA and Glaxo, the comapany that produces Avandia, had known about the cardiovascular risks of the drug for a while without explicitly having informed the public or the medical community about it. This article questions the reliability of the US drug approval and monitoring system.

The credibility of this article stems from both its publisher The New York Times, as well as, the scientists that performed the study that this article overviews. The original article that was overviewed in the New York Times article was based on the studies of Dr. Steven Nissan, the chief of cardiovascular medicine, and Kathy Wolski of the Cleveland clinic. Dr. Nissan was, also, among the first doctors to question the cardiovascular safety of Vioxx, a pain-killer produced by Merck which was withdrawn from the market in 2004 because of inducing high risks of heart attack, This article is very useful to my research because it reveals flaws in the FDA system, as well as, the tendency of pharmaceutical companies to market their product regardless of their medically dangerous side affects.

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