European Union (EU) residents have less confidence in vaccine safety than people in any other region in the world. From the perspective of the powerful pharmaceutical industry and its bought politicians, this growing skepticism about vaccine orthodoxy cannot be permitted to gain further momentum. Ignoring massive protests by citizens and municipal authorities, the governments of France, Italy and other EU nations have begun methodically and paternalistically enacting new vaccine laws that seek to erase any remaining ability for citizens to weigh risk-benefit information and make vaccine decisions for themselves.

And now, the European Parliament (the EU's law-making body) has thrown its considerable weight into the fray to promote EU-wide coordination of vaccination policies and programs. Not content to let vaccination policy remain "a competence of national authorities," the Parliament's committee on the Environment, Public Health and Food Safety adopted a resolution in March 2018 to promote stricter policies both "within and outside the EU." To carry out this aim, the European Commission (the EU's executive arm) will present, in 2018, a Joint Action to increase vaccination coverage and address "vaccine hesitancy."

A query that one might legitimately pose in return, however, is whether massive lobbying by the pharmaceutical industry has rendered parliamentarians incapable of impartiality.

According to a commentary on the resolution in The British Medical Journal (BMJ), European Parliament members are unwilling to brook any dissent, characterizing all licensed vaccines as safe and dismissing information to the contrary as "unreliable, misleading and unscientific." A query that one might legitimately pose in return, however, is whether massive lobbying by the pharmaceutical industry has rendered parliamentarians incapable of impartiality.

Out-gunned by pharma

Many observers of European vaccine policy agree with EURACTIV, an independent pan-European media network, that recently noted, "Big Pharma is out-gunning its civil society and non-profit rivals in terms of lobbying, access and influence at...EU institutions." Each year, the awkwardly named European Federation of Pharmaceutical Industries and Associations (EFPIA) and its subsidiary trade association Vaccines Europe spend millions of euros and hold hundreds of closed-door meetings with European Commission members to achieve what one watchdog group characterizes as a highly "influential position in EU pharmaceutical-related policy making." The EFPIA membership reads like a "who's who" of the biggest and most powerful vaccine manufacturers, including GlaxoSmithKline, Sanofi, Pfizer, AstraZeneca, Eli Lilly and others.

The EU Transparency Register, a "voluntary system of registration for entities seeking to directly or indirectly influence the EU decision-making process," reports about 40 million euros annually in pharmaceutical lobbying expenditures. However, a corporate marketing and consulting firm estimates that the actual amount spent each year by the pharmaceutical industry on lobbying is closer to about 90 million euros. A sizable portion of these monies fund full-time lobbyists who can push the industry's priorities and secure both high-level and "unit-level" meetings with decision-makers and staffers in Brussels. Most of these meetings take place "out of sight and beyond scrutiny." The 55-to-1 passage of the European Parliament committee's vaccination policy resolution (with only three abstentions) suggests that these lobbying efforts have been resoundingly successful.

A multi-billion euro industry

The Innovative Medicines Initiative (IMI) furnishes another illustration of the pharmaceutical industry's outsized influence on European policy- and decision-makers. The IMI, which is Europe's largest public-private partnership, is a joint venture between the EU and the EFPIA that ostensibly aims to "speed up the development of better and safer medicines." However, investigative reports indicate that "the billions already invested by the EU in the IMI have effectively been a giant subsidy for the [pharmaceutical] sector rather than a boost for medical research." What is the broader conclusion that these reporters draw from this example?
"This capture of EU funding by the pharmaceutical industry reflects a parallel capturing of the narrative on EU health policy, whereby the sector's intentions and motivations go largely unquestioned by policymakers" (emphasis added).
Quelling dissent while neglecting safety concerns

Ultimately, the European Parliament's top-down resolution seeks to centralize vaccination policy and lessen individual EU member nations' ability to forge their own independent policies, as the Swedish Parliament chose to do when it bucked the general trend and voted down compulsory vaccination in 2017. Conspicuously missing from the debate are any parliamentarians courageous enough to speak to the "statistical trickery" that the vaccine industry routinely uses to mask important safety issues. Fortunately, some members of the scientific community still are willing to voice the questions that need to be asked, and at least one journal-The BMJ-has been willing to resist censorship pressures and publish some of those vital questions.

The issue of mandating vaccines is familiar to citizens of the U.S., where religious and philosophical exemptions to vaccination are being threatened in nearly all 50 states. Three states-West Virginia, Mississippi and California-allow only medical vaccine exemptions, which are reportedly difficult to obtain because health officials are subjecting the doctors who provide them to undue scrutiny. There's no doubt that concerned vaccine safety advocates in the U.S. will be paying close attention to what's transpiring with European vaccination policy.

Part 2 Vaccine Mandate Efforts in Europe Get Push back

In March and April, The British Medical Journal (BMJ) published short news summaries about the European Parliament's resolve to shore up the European Union's (EU's) "fragile" vaccination programs. According to the BMJ reporter (Brussels-based journalist Rory Watson), the Parliament's March 2018 resolution represented a blanket denunciation of "unreliable, misleading and unscientific information on vaccination." Seven individuals-scientists, retired health professionals and journalists from England, Scotland, Wales, South Africa and the U.S.- immediately wrote to The BMJto set the record straight.

Is the European Parliament itself guilty of spreading misinformation? The 15 referenced letters suggest that this may be the case, focusing, in particular, on flawed scrutiny of vaccine risks and rampant conflicts of interest.

In 15 published letters to the editor now indexed in PubMed, the letter-writers argue that "it is...well beyond the brief of the European Union Parliament, or even good sense, to assert that an entire class of products is safe as an absolute truth, and without any qualification." Is the European Parliament itself guilty of spreading misinformation? The 15 referenced letters suggest that this may be the case, focusing, in particular, on flawed scrutiny of vaccine risks and rampant conflicts of interest.

Letters on hidden vaccine risks

Many of the BMJ-published letters refer to the failure of pre-licensure clinical trials and short-term post-marketing surveillance to detect serious problems with vaccines. To show that the "rigorous testing" cited by the European Parliament as evidence of vaccine safety is not "infallible," a letter-writer cites two examples. First, "post-marketing surveillance failed to detect the scale of the problem" (an excess risk of aseptic meningitis) associated with the Urabe-strain measles-mumps-rubella (MMR) vaccine introduced in the United Kingdom (and other countries) in the 1980s and 1990s-and the delay in removing the vaccine from the market caused harm to many. Second, thousands of children and adolescents developed narcolepsy after receiving the Pandemrix "swine flu" vaccine in 2009-2010; neither the clinical trials nor post-marketing studies in children had identified the safety signal. Another letter-writer comments,
"If vaccine regulators were serious about safety, the entire vaccine fleet would have been grounded following the Pandemrix narcolepsy disaster, to check for the same mechanism of failure in other vaccines. But nothing of that sort happened."
...subjects vaccinated with the newly approved SHINGRIX vaccine (versus placebo) disproportionately experienced cardiac serious adverse events (SAEs), but the package insert for the vaccine (dated Oct. 2017) makes no mention of any cardiac risks.

The letters' authors mince no words when calling out the duplicity of much vaccine safety science. One common tactic involves manipulation of study designs and statistics. For example, small safety studies can be designed such that they are prone to false negatives (meaning that they fail to observe a difference between groups when in truth there is one) - this allows vaccine manufacturers "to say that any increases in adverse events are 'not significant.'" Another way to avoid looking head-on at critical safety issues is to ignore mechanistic evidence in favor of dubious epidemiology, or sideline important research topics-such as the immunotoxicity of aluminum adjuvants, the prospect of immune overload with increasing numbers of vaccines and antigens or the role of molecular mimicry in vaccine-induced autoimmunity.

Yet another letter describes recent shenanigans that had the effect of suppressing relevant safety information. In September 2017, an FDA document indicated that subjects vaccinated with the newly approved SHINGRIX vaccine (versus placebo) disproportionately experienced cardiac serious adverse events (SAEs), but the package insert for the vaccine (dated October 2017) makes no mention of any cardiac risks. The letter's author concludes that "doctors who administer this vaccine are being kept in the dark about these SAEs," limiting their ability to recognize or report adverse events when they occur.

Letters on conflicts of interest

Several letter-writers to BMJ call attention to the conflicts of interest that prevail among leading vaccine policy-makers in Europe. For example, one writer understatedly asks whether Oxford University professor Andrew Pollard may be in an "ambivalent position" when it comes to discussing vaccine side effects and risks. Pollard directs the Oxford Vaccine Group and chairs the Joint Committee on Vaccination and Immunisation (JCVI), which advises UK health departments on vaccination. As the letter-writer points out, "minutes of recent JCVI meetings show that [Pollard] is involved with, amongst others, the Gates Foundation, GAVI [global vaccine alliance], and the European Medicines Agency [EMA]." (For example, see page 17 of the JCVI's February 7, 2018 minutes.)

...the BMJ letters raise questions about "the very objectivity of European institutions," highlighting the European Medicines Agency's disproportionate funding (90%) from pharmaceutical companies...

The EMA is responsible for "ensuring that all medicines available on the EU market are safe, effective and of high quality." However, the BMJ letters raise questions about "the very objectivity of European institutions," highlighting the EMA's disproportionate funding (90%) from pharmaceutical companies and noting the Nordic Cochrane Centre's scathing condemnation of the EMA's lack of independence from industry. (The Nordic Cochrane Centre is part of the independent Cochrane Collaboration that produces "gold standard" systematic reviews.) One of the Nordic Cochrane Centre's many critiques is that the EMA allowed Andrew Pollard to chair a committee on HPV vaccine safety despite conflicts of interest with HPV vaccine manufacturers-and his a priori public declaration that there was "no evidence of safety problems." In short, says one of the letter-writers, "it is not really clear...that the EMA has a culture of ensuring things are safe, rather than just a culture of saying things are safe, and standing on their dignity" (emphasis added).

Letters explaining what's needed

Instead of skullduggery and "window dressing research," entities such as the European Parliament could be of actual service to the public if they adopted "a more realistic, open and transparent approach" and facilitated a "disinterested, comprehensive exchange of information between all parties, ensuring fully informed consent, or dissent, to vaccination." As one of the BMJ-published letters states:
"They would do well to legislate for safer vaccines, more extensive clinical trials and studies prior to licensing with a robust and very sensitive heightened post marketing surveillance system to instantly detect any adverse reactions (which might not have been detected in the trials due to the size of the cohort) and respond immediately with the removal of the product from the market for further investigation. All too often reports of adverse events are dismissed as being in line with what was statistically expected and not indicative of a serious problem or denied altogether on the argument that there is no evidence of causation. Acknowledgements of adverse events in hindsight (sometimes many years later) are of no consolation to the victims."
Another letter suggests that if members of the European Parliament "research[ed] the subject thoroughly and from a neutral position," they would understand "why there is this 'vaccine hesitancy.'" Otherwise (and only slightly tongue in cheek), this author concludes that "parents and the informed public will have to unite and devise a strategy to tackle [the] 'Vaccine Study Reluctance,' 'Vaccine Ineffectiveness Denial,' 'Vaccine Injuries & Deaths Disassociation Complex' and 'Obsessive Coincidence Disorder' that are now rife within the medical and science profession!"

World Mercury Project applauds the fact that BMJ published letters that air an open and honest debate on a topic more often denied the opportunity for open debate. The letters go beyond soundbites to provide information that the public needs to make truly informed vaccine decisions. It is highly unlikely that these same letters would have been published in the American media or in virtually any other academic journal. Not only do journals (and the media) financially rely on the pharmaceutical industry as leading advertisers, but journals also depend on the industry to purchase thousands of reprints and sponsor pricey subscriptions. Describing the "hijacking" of policy by a complicit industry and captured agencies, a letter-writer cautions that "if as result of these institutional movements to suppress debate we end up not being able to discuss vaccine risks at all, we will be in a pretty poor place." America might already be in that place.