Valencia, 6th November 2015
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a detailed scientific review of the evidence surrounding reports of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines. This review concluded that the evidence does not support a causal link between the vaccines (Cervarix, Gardasil/Silgard and Gardasil-9) and development of CRPS or POTS. Therefore, there is no reason to change the way the vaccines are used or amend the current product information. Furthermore, they conclude that the benefits of HPV vaccines continue to outweigh their risks.
The Association of Affected young women by HPV vaccines in Spain, AAVP, sent all the information available in our Spanish Database along with information about Italian, French, Colombian and Mexican affected young women to the EMA –as it is an international issue. We sent to the EMA, as requested, scientific literature to be evaluated, our concerns and petitions to be considered. We believe this big effort has been worthless, because from our point of view the process of evaluation should be carried out taking into consideration the following facts:
- PRAC members must be members without conflict of interest. We do not know if this is the case.The English Secretary of the AHVID Association Caron Ryalls, asked for this information and EMA argued that they couldn’t provide any documentation or information relating to the review until the process was finished which will be May 31st 2016 .From our point of view, this information is relevant and should be published in order to be transparent. Obviously if the PRAC members have conflict of interests their conclusions will not be objective.
- The studies conducted by the PRAC should be individualized and followed up. We don´t know if this has been done, because we will not have the assessment report until the process is finished that will be by 31st May at the latest. It is really important to know the studies they have evaluated to draw their conclusions. As we see it, it is really confusing issuing a press release while the review is still open while stating they can’t release documents because it might influence the review.
- These two syndromes: POTS and CRPS are not usually diagnosed, so the number of these cases is not high. As a consequence there is under reporting of these syndromes. If somebody analyses the affected women databases AAVP sent to EMA, it is easy to determine that most of the girls suffer the same AR´S. From those cases, more than 300, only a few have been diagnosed with CRPS or POTS and most of them are without diagnosis.
- Epidemiologic studies should be carried out by independent experts to determine the frequency of the AR´s versus the population based rates.
AAVP has conducted a study from the EMA AR´s database and it calls our attention the high number of reports that ended in death. Furthermore, the reports which require investigation or follow up are most of them, the ones whose outcome was fatal, not specified, not recovered/not resolved, recovered/resolved with sequelae, the ones that are recovering or the ones that are unknown. It can never be supported that there is no causality; that they are coincidental or psychological if those reports are not investigated by serious and independent experts, with serious, independent epidemiologist studies and meta-analysis. Statements to the contrary are not scientific at all.
Despite this, the EMA states the benefits of HPV vaccines continue to outweigh their risks. How can they reach to this conclusion if the evaluation process will end by May 2016?
But nobody can deny that the risks are there and nobody is doing anything to investigate them and to find treatments to heal these girls. Governments should encourage the work of doctors on recognition of side effects to protect the health of the affected girls, and it seems they are doing just the contrary.
Who is responsible for the risks that these vaccines have?
It seems that nobody cares.
AAVP will continue fighting for the recognition of the AR´s as they are listed on the leaflet of the products and to gain support from our Health Authorities to investigate the risks and find treatments for those injured.
Next Friday, 13th November AAVP and its legal representative will continue their conversations with the General Director of Public Health and the General Director of the Spanish Agency of Medicines in the Spanish Health Ministry.
Alicia Capilla, President
ASOCIACIÓN DE AFECTADAS POR LA VACUNA DEL PAPILOMA (AAVP)