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 BMJ to 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. Other 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.