SANE Vax, Inc. is Concerned about Missing Data in the Reports
The media went wild last week announcing the report published in the Feb. 3 issue of the New England Journal of Medicine, (NEJM) was funded by the vaccine's maker, Merck & Co., 1 stating Gardasil was 90 percent effective in older teenaged boys and young men.
Gardasil was approved for use for boys ages 9 through 26 in 2009 by the U.S. Food and Drug Administration. U.S. Centers for Disease Control and Prevention advisory panel voted against routine use of the vaccine in boys and men.
Am sure the researchers/marketers at Merck decided a study announcing that Gardasil was equally effective in preventing genital warts would increase uptake/sales of the vaccine. This is a marketing tactic – not a study – and not even an independent study.
The study was conducted on 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla., The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18.2.
SANE VAX, Inc. is asking – What about boys ages 9 to 15? Why weren’t they included? By the time a 9 year old reaches the age of 16 – the vaccine will no longer be effective.
SANE Vax wants to know the length of time for the study. Months? Years? Even NEJM does not even report this. Where are the long term results? How can there be any?
Fred Wyand, director of the HPV Resource Center at the American Social Health Association stated; "Studies like this underscore the 'human' in human papillomavirus."3. Well, let’s look at human viruses. They lay dormant, and they mutate. Genital warts come and go in both male and female populations. Viruses are triggered/stimulated by environment and stress – as well as lifestyle. Viral patterns are impossible to predict. The only thing in life that is constant is “change.”
Gardasil is only effective for 5 years. What happens after that? What if the viruses come back in full force? Oh, yeah another vaccine.
Healthy boys? What kind of study is that? Define “healthy.” What about unhealthy boys – boys with pre-existing or a family history of allergies or autoimmune diseases. The same “healthy” demographic was used in the clinical trials for adolescent girls – and there are now 21,292 reported adverse reactions and 93 deaths reported to VAERS.
Why perform a study on another healthy population when the initial study has caused so many injuries to girls ages 9 to 26? SANE Vax Inc. does not think this is science-based medicine at all…. It is more like the fairy tale, “The Emperor has no Clothes.” When are medical consumers and practitioners going to realize that Merck has pulled the wool over our eyes again?
This study would more aptly be titled “One Less Boy to Get Genital Warts.” SANE Vax fears that this campaign will turn into ‘One More Boy Adversely Injured.’ How can the outcome be any different?
SANE Vax Inc. is concerned about the missing data or data not being reported in this study. The line between marketing and science based evidence is getting pretty thin. Medical consumers deserve to have independent studies conducted on the safety and efficacy of any and all medications developed for non-life threatening medical issues. Parents getting the HPV vaccine for their sons need to have the answers to all of these issues for informed consent. The days of blind faith are over.
Sources:
1. New England Journal of Medicine, Feb 3, 2011, Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males, http://www.nejm.org/doi/full/10.1056/NEJMoa0909537
Supported by Merck and by grants (M01-RR-00079 and UL1 RR024131, to Dr. Palefsky) from the National Center for Research Resources and by a grant (RO1 CA098803, to Dr. Giuliano) from the National Institutes of Health.
Drs. Giuliano, Ferris, Moreira, Penny, and Palefsky report receiving grant support from Merck, either personally or through their institution; Dr. Penny reports receiving grant support from GlaxoSmithKline; Dr. Goldstone reports receiving grant support from Qiagen; Drs. Giuliano, Ferris, Moreira, Hillman, and Chang report receiving speaking fees or fees for board membership from Merck; Dr. Moi reports that his institution has received funding from Merck; Dr. Penny reports having stock or stock options in AstraZeneca; Dr. Palefsky reports receiving consulting fees from GlaxoSmithKline; Drs. Giuliano, Palefsky, Goldstone, Moreira, Moi, and Chang report receiving travel reimbursement from Merck; Dr. Bryan reports having an approved, filed, or pending patent related to subject matter discussed in this article; and Dr. Bryan, Dr. Marshall, Dr. Vuocolo, Dr. Barr, Dr. Haupt, Mr. Radley, and Dr. Guris are employees of Merck and own Merck stock or stock options. No other potential conflict of interest relevant to this article was reported.
2. New England Journal of Medicine, Feb 3, 2011, Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males, http://www.nejm.org/doi/full/10.1056/NEJMoa0909537
3. MedlinePlus, Feb. 2, 2011, Gardasil Vaccine Guards Against HPV in Boys, http://www.nlm.nih.gov/medlineplus/news/fullstory_108399 ...
For more information, visit our site at http://sanevax.org/.
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THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.
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