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HPV Vaccines and Evidence Based Medicine

February 6, 2013, Posted by: , 1 Comment Leave a Comment

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Since FDA’s 2006 ‘fast-track’ approval of Merck’s Gardasil vaccine, the public has been inundated with messages about the dangers of cervical cancer as well as the alleged best prevention tool, HPV vaccination, either Gardasil or its competitor, GlaxoSmithKline’s Cervarix. Young girls are implored to “Be one less” in Merck’s advertising campaign, which was so successful, Merck was given an award for creating “a market out of thin air”.1 Our film making team has been repeatedly told of doctors being very pushy in their attempts to vaccinate their young patients when parents resist. And just last year, California passed a law that would allow school nurses to vaccinate children as young as age 12 for HPV and other sexually transmitted diseases, without parental consent.2

Since 2006, the public has been assured in a slew of papers from scientists and government health officials that Gardasil and Cervarix are totally safe and totally effective despite the fact that 128 deaths have been reported to the US Vaccine Adverse Events Reporting System (VAERS) after those vaccinations and thousands and thousands of other adverse reports including autoimmune disease, demyelinating disease, seizures, strokes, paralysis, chronic fatigue, and more have been reported.3 We hear nothing in the corporate media about the fact that Merck used aluminum, a known neurotoxin, as a placebo in most of its safety trials nor that HPV alone is not proven to cause cervical cancer.4 We hear nothing of the incredible success routine Pap smears have had on cervical cancer rates in the developed world where cervical cancer rates have fallen 70% in recent decades to a very low 1.7 per 100,000 and that Pap tests have accomplished this with no side effects.5 We hear no debate about the necessity to repeat these vaccinations every few years as any “immunity” induced by them is fleeting and the average age of onset of cervical cancer is 54.

Against this very biased backdrop, some families whose children have been injured or died after these vaccines are shining a light on the “science” used to justify these vaccines and the light reveals the degree to which the science is based on half truths and distortions. Here is a letter from these families recently published in the journal Infectious Agents and Cancer:

Commentary on Editorial entitled “HPV Prevention Series” authored by Silvia de Sanjose

Emily Tarsell   (2013-02-04 14:41)  Private Practice

Editors,

As now better informed consumers who know the dire consequences of misinformation, we feel compelled to comment on the Editorial entitled “HPV Prevention Series” authored by Silvia de Sanjose [1]. The author makes several statements which are at best, half-truths.

The statement that cervical cancer “remains to be the second leading cause of cancer death in women in less developed regions of the world” is at best, a half-truth. It fails to mention the women living in the developed countries where cervical cancer death rates are very low. In the U.S.A., cervical cancer is 14th in frequency on the list of causes of cancer death [2] and its death rate is 1.7 per 100,000 women; in Australia and New Zealand its death rate is 1.4 and 1.6 per 100,000 respectively [3], and it is widely accepted that cervical cancer death only occurs in unscreened or rarely screened women [4]. Over-extrapolation of the clinical trial data and the benefits obtained in a population with high cervical cancer rates compared to a population living in the developed countries is inappropriate and misleading.

The statement “HPV is the necessary cause of cervical cancer”in the Editorial is also a half-truth. The whole truth should be that HPV infection is not in itself a sufficient cause of cervical cancer [5].

The author states that “major reduction of HPV related disease is feasible” through such strategies as “routine HPV vaccination of pre-adolescent and young women.” However this statement is not supportable by scientific evidence as there is no pre or post licensure research that HPV vaccines are more effective than Pap screening in reducing incidences of cervical cancer or pre-cancerous lesions [6].

Furthermore, in developed countries, to achieve the claimed efficacy of 70% would involve mass vaccination of every young girl between the ages of 9-12 to reduce one death due to cervical cancer per every 100,000 girls vaccinated. The cost of vaccinating 100,000 young girls is $40,000,000-$100,000,000 in the U.S.A. at $400 to $1,000 per vaccine regimen [7]. It is not cost effective to invest so much money to prevent one death caused by cervical cancer when the cancer occurs at an average age of 54 [8] and death only if it remains undiscovered and untreated. We have scientifically proven safe and effective alternatives for preventing cervical cancer such as improved cervical screening interventions which are far less harmful than the HPV vaccine. The serious damage to the lives of some young vaccine recipients who experienced vaccine adverse reactions and the monetary cost of the vaccine far outweigh the potential benefit of the HPV vaccines.

We agree with the Editorial intent to invite articles “to widen our minds, to increase our capacity for action and ultimately to increase the health of our population.” However those intentions cannot be achieved with half-truths and misinformation, or by dismissing inconvenient truths as anti-vaccine activism or by ignoring science.

After undertaking our own research, we now realize that we were and continue to be misinformed about the necessity, safety, efficacy and economic value of HPV vaccines. It is the responsibility of scientific publications to ensure that the information presented is accurate, balanced and unbiased. Toward that end and in the interest of public health and safety, we submit our comments.

Sincerely,

Emily Tarsell – Sparks, MD, USA tarsell@comcast.net
Stephen Tunley – Sydney, Australia stunley@balmain.com.au

Identifications of 50 additional consumers who endorse these comments are available; they also experienced dire consequences as a result of misinformation regarding hpv vaccines.

References
[1] de Sanjose S: HPV Prevention Series. Editorial. Infect Agent and Canc 2012, 7:37.
[2] http://www.cancer.gov/cancertopics/factsheet/cancer-advances-in-focus/cervical
[3] http://appliedresearch.cancer.gov/icsn/cervical/mortality.html
[4] Janerich DT, Hadjimichael O, Schwartz PE, et al.: The screening histories of women with invasive cervical cancer, Connecticut. Am J Public Health 1995, 85:
791-4.
[5] http://www.cancer.gov/cancertopics/pdq/screening/cervical/HealthProfessional/page2
[6] Tomljenovic L, Shaw C: Too fast or not too fast; the FDA’s approval of Merck’s vaccine Gardasil. J Law Med Ethics 2012 Fall, 40: 673-81.
[7] http://www.realfoodhouston.com/2012/07/30/gardasil-and-cervarix-whats-the-controversy-about-the-hpv-vaccine/
[8] Lee NC: Testimony before the House Committee on Commerce, Subcommittee on Health and Environment, March 16, 1999. http://www.hhs.gov/asl/testify/t990316b.html

Competing interests

Consumers who were misinformed about the necessity, safety and efficacy of HPV vaccines.

http://www.infectagentscancer.com/content/7/1/37/comments#1334696