European Agency to Investigate HPV Vaccines

July 16, 2015December 10, 2018Big Pharma

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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.

The Svenska Dagbladet article went on to state:

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 syndrome

The EMA was quick to note the review does not question that the benefits of HPV vaccines outweigh the risks.

Suddenly, parents around the world began to experience the same kind of hope those in Denmark did. Someone was finally going to listen to what they had been saying for months, sometimes years. Instead of brushing off their daughters’ (and sons’) new symptoms as psychosomatic, their children’s new medical conditions would be examined as possible side effects of the HPV vaccines they all had taken.

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.

Do these parents finally have a reason to be hopeful; or is the light they see at the end of the tunnel an oncoming train?”

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).

The following statements from the EMA press release are not strictly accurate:

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.

This is not exactly a good start if one wants to instill public confidence in the outcome of a safety investigation. How can one trust the outcome of an investigation being conducted by an agency that has so little regard for accuracy in their press releases.

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.

This section raises several questions in the mind of even the most casual observer.

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?

As a matter of fact, the currently used diagnostic criteria for Complex Regional Pain Syndrome (CPRS) was only published in 2007. Even that set of diagnostic criteria is under review for proposed changes. How is the average medical professional supposed to make an accurate diagnosis of this disorder when the experts can’t agree on how to do so?

The same is true of POTS diagnostic criteria. Post orthostatic tachycardia syndrome is not a disease, but simply a cluster of symptoms that are frequently seen together. Since POTS is not a disease, it is fair to say that POTS is caused by something else. However, figuring out what is causing the symptoms of POTS in each patient can be very difficult, and in many cases, patients and their doctors will not be able to determine the precise underlying cause. This makes it pretty convenient for the stakeholders, wouldn’t you say?

Quite frequently people live with these two conditions for years without receiving an accurate diagnosis. Could that be the reason the EMA chose these two disorders to examine?

These facts make it relatively easy to keep the number of reports low, particularly when quoting the rates against distributed doses instead of administered doses.

Where does that leave all of the HPV vaccine recipients who currently exhibit the symptoms of these two disorders but have not obtained a diagnosis yet?

Unreported with no diagnosis and consequently no treatment protocol!

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?

The EMA did mention examining data, but will this data come from anyone outside the marketing authorization holders’ control?

Why did the PRAC make no mention of efforts to interview the families of those affected?

Why are they making no apparent effort to talk to physicians on the ground – the people most likely to have experience observing new medical conditions after HPV vaccine administration?

Is the PRAC going to extend their probe to include examination of peer-reviewed publications indicating possible safety concerns surrounding HPV vaccines? Better yet, how about talking to the authors of these publications?

So, what hope do thousands of affected families have?

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.

Citizens of the world will no longer stand back and allow government health officials to betray the public trust!

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