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Colombian National Academy of Medicine asks for a change in current HPV vaccine application protocols

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Category: Número 2

Colombian National Academy of Medicine

Created by Law 71/1890 - Ratified by Law 02/1979

March 14th, 2016

(Translated from Spanish by asi-compartimos.com and Pompilio Martínez, M.D.)

Dr. Alejandro Gaviria Uribe


Minister of Health and Social Protection

City-


Minister:

The ad hoc Subcommittee to study the HPV vaccine at the Health Commission of the Colombian National Academy of Medicine, after listening to different independent experts, among them the former director of the Colombian National Institute of Health, Dr. Fernando De la Hoz, to Dr. Nubia Muñoz and two doctors from the pharmaceutical company Merck, and after carefully reviewing the available scientific literature, CONSIDERS necessary to ask the Ministry of Health and Social Protection (MSPS) a change in current HPV vaccine application protocols.

The reasons for this request are grounded in growing national and international information about the association between this vaccine and the onset or aggravation of various autoimmune diseases. While studies of these low incidence diseases lack sufficient statistical power to obtain robust and conclusive results, the number of cases of vaccinated people who have developed these diseases is increasing (1-3). Indeed, a high incidence of autoimmune and inflammatory conditions associated with HPV vaccination and a significant risk of developing systemic lupus erythematosus, vasculitis and arthritis have recently been documented in the Vaccine Adverse Event Reporting System (VAERS) (2,3). In addition, the number of reported cases of dysautonomia is increasing (4.5).

The Commission, of course, recognizes the importance of preventing such a serious disease as is cervical cancer, but believes it is more important to draw the attention of the Ministry of Health to the following aspects:

1. The risk-benefit relationship of developing an autoimmune disease after vaccination against HPV has not yet been resolved
2. The available data are limited to provide definitive conclusions about a causal relationship between the HPV vaccine and symptoms presented by vaccinees.

3. Given the recent increase in reports of adverse effects, it is expected that studies with sufficient sample size would confirm if it is safe to vaccinate girls with autoimmune diseases against HPV.
4. Given the [long] stages of development of cervical cancer, at this point there is not enough information and there shouldn’t be, to know the effectiveness of the HPV vaccine to prevent cervical cancer. (6). The existing data refers to the prevention of other genital lesions caused by HPV strains or precancerous lesions, which according to available data have very high rates of spontaneous remission.
5. In these circumstances requirements about HPV vaccine safety should be much stricter, since it’s being applied to people previously deemed "healthy".

6. The Hippocratic term "primum non nocere" should permeate all medical and public health actions.

7. It is important for national and international experts to give their opinion on the safety of the vaccine, and to make public their conflicts of interest when they receive funding from the pharmaceutical industry. The current public uncertainty about the effects of the HPV vaccine and the absence of transparent information, are affecting the confidence of the population in other vaccines and may have negative impact on coverage of the Expanded Program on Immunization (EPI).

8. The Healthcare Commission considers that the Ministry of Health must explicitly exclude from vaccination [individuals] with a family history of autoimmune diseases or the presence of any of them (7.8). In order to do this, current vaccination protocols must change and this information should be made available to the public.

It is also suggested that a personalized analysis of each individual to be vaccinated is needed, including evaluation of personal and family history of autoimmunity, under the medical paradigm P5 (knowledge of each Population and the factors associated with diseases: Prediction, Prevention, Personalization and Participation) (9) and give greater importance to pharmaceutical surveillance, taking into account all possible side effects of vaccinations (10).

It is necessary that vaccination be accompanied by a strong strategy of sexual and reproductive education to those who benefit from it, since that is not happening at the present time. Likewise informed consent should also be required in cases of girls with a history of autoimmune disease.

Finally, we would like to point out that the [medical] references accompanying this document do not represent a systematic review of the [scientific] literature and are offered to support the opinions and requests expressed herein; none of the members of the committee contradicts the benefits of the vaccination program nor is part of any association against vaccination, nor have conflicts of interest with any pharmaceutical company. We appreciate your kind attention and remain at your disposal to address any additional concerns.

Sincerely
(signed)
Juan Mendoza Vega 
President


Jose Felix Patiño Restrepo
 Coordinator Health Commission


National Academy of Medicine
Created by Law 71/1890 - Ratified by Law 02/1979
MINISTRY OF HEALTH AND SOCIAL PROTECTION


Radicado No: 201642300467362
DEST: 1000 SALT MLNISTRO REM: ACADEMY NACIO
03/14/2016 9:25 Fol: 3 Anex: 1 Desc Anex:
See your procedure at http: www.minsalud.gov.co Verification Code: 302c6

References

• Anaya JM, Reyes B, Perdomo-Arciniegas AM, Camacho-Rodríguez B, Rojas- Villarraga A. Autoimmune/auto-inflammatory syndrome induced by adjuvants (ASIA) after quadrivalent human papillomavirus vaccination in Colombians: a cali for personalised medicine. Clin Exp Rheumatol. 2015 May 11.

• Geier DA, Geier MR. A case-control study of quadrivalent human papillomavirus vaccine- associated autoimmune adverse events. Clin Rheumatol 2015;34:1225-31.  

• Pellegrino P, Perrone V, Pozzi M, Camovale C, Perrotta C, Clementi E, Radice S. The epidemiological profile of ASIA syndrome after HPV vaccination: anevaluation based on the Vaccine Adverse Event Reporting Systems. 2015; 61: 90- 6. 


• Biitshteyn S. Postural tachycardia syndrome following human papillomavirus vaccination Eur J Neurol. 2014;21:135-9. 


• Brinth LS, Pors K, Theibei AC, Mehlsen J. Orthostatic intolerance and postural tachycardia syndrome as suspected adverse effects of vaccination against human papilloma virus. Vaccine 2015;33:2602-5. 


• Tomljenovic L, Shaw CA. Too fast or not too fast: the FDA's approval of Merck's HPV vaccine Gardasil. J Law Med Ethics. 2012; 40: 673-81. 


• Chao C, Jacobsen SJ. Evaluation of autoimmune safety signal in observational vaccine safety studies. Hum Vaccin Immunother 2012; 8:1302-4. 


• Grimaldi-Bensouda L, Guillemot D, Godeau B, Bénichou J, Lebrun-Frenay C, Papeix C, et al. Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects. J Intern Med. 2014; 275:398-408 


• Anaya JM. Acceso a la atención en salud En busca de la medicina personalizada y el sistema P5. Medicina (Bogotá) 2014; 36: 9-12.

World Health Organization. Causality assessment of adverse event following immunization (AEFI): user manual for the revised WHO classification WHO/HIS/EMP/ QSS 2013.