by Deirdre Imus
Parents, physicians and lawmakers have embarked on an at times heated dialogue about the Human Papillomavirus (HPV) vaccine to determine what is best for our nation’s children. With pending legislation in 40 states and mandates in two, the efficacy, cost and best method of disease prevention is in question.
The FDA approved the Human Papillomavirus vaccine, Gardasil®, in June 2006 for females ages 9-26 to protect against cervical, vulvar and vaginal cancers caused by HPV types 16 and 18 and genital warts caused by HPV types 6 and 11.1 In October 2009, it was approved for males ages 9-26 to protect against genital warts, which affect about 2 out of every 1,000 American men annually in newly diagnosed cases.2 Recently, in October 2011, the Advisory Committee on Immunization Practices, which advises the CDC, voted to recommend the vaccine specifically for 11-and-12-year-old boys.3
Despite the push to vaccinate, the CDC reports that in 90% of HPV cases, the body’s immune system clears the virus naturally within two years.4 Cervical cancer remains the easiest female cancer to prevent, with regular screening through the Pap smear and HPV test, and follow-up.5 The vaccine “is not effective against established cases of HPV or against some HPV strains, and therefore cervical cancer screening continues to be necessary.”6
Still, each year in the U.S., about 12,000 women are diagnosed with cervical cancer and almost 4,000 die from this disease.7
Only two states - Virginia and Washington, DC - mandate the vaccine for sixth grade girls to attend school, though parents may opt out. Over 40 other states have related legislation in place or pending legislation,8 and the question remains: are the potential risks worth the potential benefits? With 20,096 reports of adverse reactions from Gardasil vaccination in the VAERS (Vaccine Adverse Event Reporting System) database as of September 15, 2011,9 the safety of HPV vaccination has been questioned.
Renowned scientist Dr. Sin Hang Lee is a practicing pathologist in New Haven, CT and at Milford Hospital (CT) with over 50 years experience in medical research.10 In a recent phone interview with The Deirdre Imus Environmental Health Center, he asserted that given the approximately 40 million doses of Gardasil® distributed as of September 15, 2011, there is a serious reaction rate of approximately 12.4 per 100,000 recipients. The CDC categorizes serious reactions as those that indicate “hospitalization, permanent disability, life-threatening illness, congenital anomaly or death.”11 The CDC reports that of the adverse events reports following Gardasil® vaccination, 8% are categorized as “serious.”12 The WHO calculates that the age-standardized death rate for cervical cancer in the U.S. is 1.7 per 100,000.13
Dr. Lee has also weighed in on the issue with results found in his laboratory. Using nested PCR technology, Dr. Lee found synthetic recombinant DNA in 13 vials of Gardasil vaccines from around the world. The problem, Dr. Lee asserts, is that the insoluble recombinant DNA binds to the vaccine’s aluminum adjuvant and can enter the human cell, causing gene mutation that could lead to brain damage and other serious illness including cancer. Dr. Lee’s findings await publication.
The FDA responded to these findings on October 21, 2011, stating, “Gardasil does contain recombinant HPV L1-specific DNA fragments, but these are not contaminants. DNA encoding the HPV L1 gene is used in the vaccine manufacturing process to produce the virus-like particles that make up the vaccine. The presence of these DNA fragments is expected, is not a risk to vaccine recipients, and is not a safety factor. DNA is the‘blueprint’ for the majority of living organisms and carries the genetic instructions for how cells function and grow.” 14
For some in the HPV debate, another concern are the relationships between the Federal government and the for-profit manufacturer, Merck. NIH Record publicized the critical role of government researchers in the development of Merck’s Gardasil vaccine in the February 2007 cover story, Bridging the Licensing Gap: “Science meet Industry, Industry meet Science. This pairing — of NIH‐and FDA‐developed technologies and the companies interested in licensing them — wouldseem to be a perfect match.”15
The article chronicles NIH’s new website allowing companies to search government discoveries with the intent of finding opportunities for commercial profit. NIH’s Office of Technology Transfer (OTT) “was created by NIH in 1989 to evaluate, protect, license and manage both NIH and FDA discoveries, inventions and other intellectual property…One of the most recent products to reach the market is Merck‐produced Gardasil, the human papillomavirus vaccine used to protect against cervical cancer. The underlying technology for the vaccine originated at NCI…”16 Less than two years later, in December 2009, the former Director of the CDC, Dr. Julie Gerberding, became president of Merck & Co.’s vaccine division, causing some to question the close ties between government and industry. 17
As state and national issues continue to be decided, each family must answer: is this vaccine safe and it is it best for my child? To help families wade through the information, our Center created Greening Vaccines resources. Ultimately, each parent has the ability and the right to partner with their healthcare provider in making an informed decision.
1,7: Gardasil Vaccine Safety: Information from the FDA and CDC, 20 August 2009 - (http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm).
2: Press Release: FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys. 16 October 2009, accessed 11 November 2011. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm
3: U.S. Advisors Recommend Gardasil HPV Shots for Boys. 25 October 2011, accessed 10 November 2011. http://www.reuters.com/article/2011/10/25/hpv-vaccine-boys-idUSN1E79O10220111025
4: CDC Fact Sheet: Genital HPV Infection – accessed 9 November 2011 - http://www.cdc.gov/std/HPV/STDFact-HPV.htm
5: CDC Gynecological Cancers: Cervical Cancer Screening – page last updated 8 November 2011, accessed 9 November 2011 - http://www.cdc.gov/cancer/cervical/basic_info/screening.htm
6: From Lab to Market: The HPV Vaccine. NIH Record, Volume LIX, No. 4. 23 February 2007, accessed 14 November 2011. http://nihrecord.od.nih.gov/newsletters/2007/02_23_2007/story2.htm
8: HPV Vaccine a Suggestion, Not a Mandate in U.S.; VA and Washington, DC Require Shots, But Parents Can Opt Out. Associated Press on MSNBC.com, 8/31/2009, accessed 9 November 2011. http://www.msnbc.msn.com/id/32628957/ns/health-childrens_health/t/hpv-vaccine-suggestion-not-mandate-us/
9: CDC Vaccine Safety: Reports of Health Concerns Following HPV Vaccination – page last updated 24 October 2011, accessed 9 November 2011 - http://www.cdc.gov/vaccinesafety/vaccines/hpv/gardasil.html#Serious
10: Bio of Dr. Sin Hang Lee on Cankercillin.com, accessed 11 November 2011. http://www.cankercillin.com/dr__sin_hang_lee.htm
11,12: CDC: Reports of Health Concerns Following HPV Vaccination. Updated 24 October 2011. Accessed 16 November 2011. http://www.cdc.gov/vaccinesafety/vaccines/hpv/gardasil.html
13: World Health Organization: Summary Reports – Human Papillomavirus http://apps.who.int/hpvcentre/statistics/dynamic/ico/SummaryReportsSelect.cfm%20-%20page%2018, table 7.
14: FDA Information on Gardasil: Presence of DNA Fragments Expected, No Safety Risk. 21 October 2011, accessed 10 November 2011. http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm276859.htm
15, 16: “Bridging the Licensing Gap: New Site Eases Industry Search for Rare Disease Technologies” by Sarah Schmelling. NIH Record. 23 February 2007. Accessed 14 November 2011. http://nihrecord.od.nih.gov/newsletters/2007/02_23_2007/story2.htm
17: Former CDC Head Lands Vaccine Job at Merck. Reuters, 21 December 2009. Accessed 14 November 2011. http://www.reuters.com/article/2009/12/21/us-merck-gerberding-idUSTRE5BK2K520091221