European Agency to Investigate HPV Vaccines
By Norma Erickson
Sunday, July 12th Svenska Dagbladet (a Swedish newspaper) released a story giving hope to hundreds of Danish families whose lives turned upside-down when their daughters began to experience multiple new medical conditions after HPV vaccine injections. This newspaper announced the European Medicines Agency (EMA) was launching a probe into possible side effects of the highly controversial HPV vaccines. Finally, these families believed they might get some answers as to why their daughters had transformed from healthy athletic girls to mere shadows of their former selves.
For years, talk of possible risks and side effects from HPV vaccines was rejected by authorities, doctors and drug companies. The decision by EMA in London, which is to be presented on Monday, according to SvD’s sources, is therefore likely to create harsh reactions.
Within a few short hours, the story was confirmed by multiple other news outlets.
A Medscape article stated the EMA had started a review on human papilloma virus (HPV) vaccines to ”further clarify aspects of their safety profile,” although the agency also points out that this review ’does not question that the benefits of HPV vaccines outweigh their risks.” This report also noted that the EMA would make no recommended changes in the use of HPV vaccines while the review was being conducted.
An ABC News article reported,
The European Medicines Agency says it has started a review of cervical cancer vaccines to see if they are linked to two rare conditions, but emphasized it hasn’t changed its recommendations for how the shots should be used.
An article in The Local, from Denmark stated:
At the request of Denmark, which has seen an increasing number of young girls suffer side effects, the European Medicines Agency said on Monday that it will take a closer look at the HPV vaccine.
The review is being carried out by EMA’s own side effects committee, PRAC, which according to Swedish newspaper Svenska Dagbladet has had internal disagreements over how to handle mounting suspected evidence of medical risks connected to the vaccines.
The Daily Mail (UK) article reported:
The safety of the HPV vaccine has today been thrown into doubt as health experts launch a review of the jab amid concerns over its side-effects.
The European Medicines Agency’s probe will focus on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndromeThe EMA was quick to note the review does not question that the benefits of HPV vaccines outweigh the risks.
This 3-minute Danish news report (with English subtitles) gives an indication of how much families around the world are depending on the outcome of a serious scientific investigation.
What kind of ‘probe’ is the EMA going to conduct?
The documentation provided by the European Medicines Agency regarding this investigation raises many questions about the voracity of their efforts. Let’s start by taking a critical look at the press release distributed by the EMA on July 13th regarding this review.
The first two paragraphs of this press release state:
The European Medicines Agency (EMA) has started a review of HPV vaccines to further clarify aspects of their safety profile. These vaccines have been used in around 72 million people worldwide and their use is expected to prevent many cases of cervical cancer (cancer of the neck of the womb) and various other cancers and conditions caused by HPV. Cervical cancer is the 4th most common cause of cancer death in women worldwide, with tens of thousands of deaths in Europe each year despite the existence of screening programmes to identify the cancer early. The review does not question that the benefits of HPV vaccines outweigh their risks.
As for all licensed medicines the safety of these vaccines is monitored by the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC).
- Statement: These vaccines have been used in around 72 million people worldwide.
- Fact: No one knows how many people have been injected with HPV vaccines because the vast majority of countries do not record administered doses. At any given time, many of the distributed doses they do keep track of may be in storage awaiting administration.
- Statement: Their use is expected to prevent many cases of cervical cancer…
- Fact: Note they use the words ‘expected to’ NOT ‘proven to’.
- Statement: Cervical cancer is the 4th most common cause of cancer death in women worldwide,
- Fact: No mention is made of the fact that over 80% of these cancer deaths occur in low to middle income countries, NOT the European Union.
- Statement: …with tens of thousands of deaths in Europe each year, despite the existence of screening programmes to identify the cancer early.
- Fact: There may be ‘tens of thousands’ in Europe, but for the European Union the cervical cancer mortality rate is 3.7/100,000 – MUCH lower than the rate of serious adverse events being reported worldwide after HPV vaccinations. Denmark for instance currently reports serious adverse events at a rate of 200/100,000 injected.
Let’s move on to the additional announcement issued by the EMA on the same date which states:
The current review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome (CRPS, a chronic pain condition affecting the limbs) and postural orthostatic tachycardia syndrome (POTS, a condition where the heart rate increases abnormally after sitting or standing up, causing symptoms such as dizziness and fainting, as well as headache, chest pain and weakness). Reports of these conditions in young women who have received an HPV vaccine have been previously considered during routine safety monitoring by the PRAC but a causal link between them and the vaccines was not established.
Both conditions can occur in non-vaccinated individuals and it is considered important to further review if the number of cases reported with HPV vaccine is greater than would be expected.
In its review the PRAC will consider the latest scientific knowledge, including any research that could help clarify the frequency of CRPS and POTS following vaccination or identify any causal link.
- How can they say these two conditions are rare before the investigation is completed?
- Since the two conditions have been considered previously, have any communications been issued to medical professionals alerting them to watch for these conditions after HPV vaccines?
- Why are they only looking at the frequency of CPRS/POTS following vaccination?
- How can an ”expected rate” be determined without examining the frequency of CPRS/POTS in unvaccinated people of the same age group as those receiving HPV vaccines?
- Since CPRS/POTS are just now being considered as a potential adverse reaction to HPV vaccines, how can evidence of a potential causal link possibly have been established?
Why were POTS and CRPS chosen for this investigation?
If one wanted to get into a truly serious discussion, they would ask why two rare, difficult to diagnose conditions were chosen to be examined instead of looking at all of the serious symptoms recipients of HPV vaccines are reporting. Is it because the symptoms of both are commonly seen in many other disorders making these two conditions difficult to diagnose?
Who does the EMA turn to in order to investigate these potential safety concerns?
Believe it, or not – In order to examine potential safety concerns with Gardasil/Silgard, Gardasil 9 and Cervarix the Pharmacovigilance Risk Assessment Committee (PRAC) is going to question the Marketing Authorization Holders (MAH’s). The Marketing authorisation holders for these products are GlaxoSmithKline Biologicals, Merck Sharp & Dohme Limited, and Sanofi Pasteur MSD.
How insane can one get? These are the very organizations which stand to lose the most should a safety issue be proven regarding HPV vaccines. Does anyone in their right mind think these organizations are going to be transparent when it comes to anything that could substantially effect their bottom line?
In this particular instance, there is a great deal of hope. The EMA may have been able to conduct their investigations like this in the past. This time it will not work.
Parents of those with new medical conditions after HPV vaccine administration are not isolated and alone. They have united around the world. They do not want further clarification – they want the truth. They are watching.
Medical and scientific professionals with genuine concerns about the safety, efficacy and need for HPV vaccinations are speaking out. They are willing fight to protect the health of future generations. They are watching.
Business as usual will no longer suffice. Medical consumers around the world will accept nothing less than open, honest scientific investigations regarding HPV vaccine issues.
The families of those negatively affected by HPV vaccine use will not surrender until their children’s health issues have been properly investigated, successful treatment protocols have been designed, and mechanisms put in place to guarantee this type of medical experimentation never gets out of hand again.
- English version: EU drug agency investigates cancer vaccines
- Medscape: Safety Profile of HPV Vaccines under Review in Europe
- ABC News: EU Drug Regulator Starts Safety Review of HPV Vaccines
- The Local (DK): Cancer vaccines under investigation by EU
- Daily Mail (UK): Just how safe is the HPV jab? Health experts launch a review amid concerns over cervical cancer vaccine’s side effects
- TV2 Denmark – YouTube with subtitles
- EMA press release
- EMA announcement
- EMA questions for Marketing Authorization Holders (MAH’s)
- International Agency for Research on Cancer
- Gardasil Firestorm in Denmark
- Complex Regional Pain Syndrome
- Diagnostic Criteria for POTS
Norma Erickson is the President of SaneVax.org, where this article first appeared.