JUSTICE RECOGNIZES WHAT HEALTH AUTHORITIES DO NOT WANT TO RECOGNIZE
By Alicia Capilla, Guest Author
The High Court of Justice of Asturias- Spain (TSJA) has condemned the Asturian Health System for the death of Andrea, a young Spanish girl who died in September 2012 after getting the second shot of the HPV vaccine. The Court recognizes the bad practice of the hospitals of Jove and Cabueñes, since they did not diagnose the pathology before the second shot of the vaccine was supplied which caused the death of the young woman.
Andrea was a young woman with a medical history of mild episodes of bronchial asthma. When she got the first shot of the HPV vaccine on July 23, 2012, she became with headache and breathing difficulty. Although, she suffered from severe asthmatic exarcebation, she got the second shot on August 23, 2012, with a sudden worsening. As a result of this, she suffered severe dyspnea and seizures only 12 hours after receiving the vaccine. She was moved to the Maternal and Child Hospital of the HUCA where she remained in the Pediatric Intensity Care Unit until she died on 8 September.
The judicial sentence acknowledges that there is a casual link with the vaccine, between the second shot and her death, despite the fact that at the trial, the Administration took advantage of the fact that the vaccine is fully endorsed by drug regulatory agencies throughout the country and that the Pharmacovigilance Risk Assessment Committee (PRAC) –with regard to this case reporting- determined that there was insufficient evidence to suggest a causal association with the vaccine. The paradox of this study and its lack of scientific rigor is clear as the Committee agreed to maintain an investigation on the signal.
The Association of Affected People in Spain by the Human Papillomus Virus Vaccine (AAVP) has been demanding since 2009 many other cases of affected victims collected in our database. We have repeatedly called on the Health Authorities of Spain to recognize adverse reactions, documented many of them in the HPV vaccines databases, in the European Medicines Agency (EMA) databases, in the Spain one and in the HPV scientific literature. Andrea´s case in not unique. There are at least five more reports of deaths collected in the database of the Spanish Agency of Medicines and Sanitary Products, for not mentioning all the reports collected in the EMA database. In spite of all this, the Health Authorities and the Pharmaceutical Company continues to deny recognition of any adverse reaction. The most regrettable of all is that they blame the young women in their adverse state of health, stigmatizing them and referring all this to psychological problems, a matter which of course lacks any scientific basis, since no epidemiological studies which prove the causality of the adverse reactions experienced by many young women and the vaccine, have been carried out in Spain.
We regret once again the poor performance of the Health Authorities that are not carrying out an adequate evaluation and monitoring system, as well as looking elsewhere instead of looking after the health of girls and young women who have had the misfortune to suffer adverse reactions as a result of a Public Health policy that seems to defend more economic and political interests than health ones. We must not forget that this immunization is applied to healthy young people and it is also in its implementation phase, so that Pharmacovigilance systems should act with due diligence and responsibility.
We are pleased that for the first time in Spain, in court, the causal link of an adverse reaction with the HPV vaccine is recognized. We show our support to Andrea´s family, because despite their misfortune they have been supported by a judicial sentence that finally protects them. It was time for justice!
Alicia Capilla
President AAVP
www.aavp.es
asociacion.aavp@gmail.com
The death of the young Spanish girl Andrea is tragic.
It is highly commendable that the High Court of Justice of Asturias- Spain (TSJA) condemned the health system and determined that the death was due to the HPV vaccine Gardasil.
Alicia Capilla, president of The Spanish Association of people affected by HPV Vaccine (AAVP) and her colleagues truly deserve international respect for their hard work in fighting for justice to prevail. May this case lead the way for justice in many similar cases, also in other countries.
Regarding international health systems, it is regrettable that they are most often unduly influenced by the vaccine industry which tones down vaccine dangers, and that health systems seldom consider unbiased information from independent vaccine experts.
Information about potential vaccine risks should be transparent, adequate and accessible so that true informed consent is possible.
Andrea, who died after Gardasil, suffered from asthma. This tragic case is a clear example where the vaccine is contraindicated.
If the Pharmacovigilance Risk Assessment Committee (PRAC) had conscientiously investigated the fathoms of unbiased information it should have determined that there certainly WAS sufficient evidence to suggest a causal association between the death and the vaccine.
In the official information about Gardasil, asthma “flies under the radar” and is seldom mentioned. However, BRONCHOSPASM is mentioned. This is closely related to asthma and occurs when a person has an asthma attack.
In Gardasil product information http://www.medicines.org.uk/emc/medicine/19016/SPC/GARDASIL/
asthma is not mentioned. Bronchospasm is mentioned and is stated as being “very rare”.
In the Gardasil package leaflet information for the user (PIL) https://www.medicines.org.uk/emc/medicine/19033 this is stated under the section for Possible side effects:
“The following side effects can be seen after the use of Gardasil:
….. Very rarely (less than 1 in 10,000 patients), difficulty in breathing (bronchospasm) has been reported”.
“Side effects that have been reported during marketed use include:
….Allergic reactions that may include difficulty breathing, wheezing (bronchospasm), hives and rash have been reported. Some of these reactions have been severe.
There is something wrong with this picture! It is extremely dubious that bronchospasm is in fact “very rare” after Gardasil vaccination.
Why? Because the vaccine industry’s information, based on clinical trials, is misleading and it is not reliable. Trial subjects are carefully selected in order to attain the most favourable results for the vaccines. Subjects who have any condition which may lead to negative results are excluded. These exclusion criteria are stated in the information for each clinical trial.
One example:
https://clinicaltrials.gov/ct2/show/NCT01206556?term=HPV+Merck&rcv_s=01%2F01%2F2010&rcv_e=12%2F30%2F2010&rank=9
Examples of exclusion criteria here are people with allergies to any component of the vaccine, to food or medicine, autoimmune conditions, weak immune systems, lab abnormalities, clinically significant disease or clinically significant findings during the screening medical history
– or physical examination that, in the investigator’s opinion, WOULD COMPROMISE THE OUTCOME OF THIS STUDY (my emphasis).
Clinical trials for vaccines are carried out by the industry itself which employs manipulation, misleading information and omission of relevant data in order to attain marketing status. By carefully selecting the subjects in clinical trials in order to attain favourable results, the populations which will ultimately receive the vaccines is not realistically represented.
When vaccines are marketed they are given to populations with a huge array of health conditions, leading to countless cases of adverse events and even deaths.