Letter to HHS director:
… All drugs licensed by the FDA undergo long-term double-blind pre-licensure clinical trials during which the rate of adverse reactions in the group receiving the drug under review is compared to the rate of adverse reactions in a group receiving an inert placebo, such as a sugar pill or saline injection. For example: Enbrel’s pre-licensure trials followed subjects up to 80 months and controls received a saline injection.3 Lipitor’s pre-licensure trials lasted a median of 4.8 years and controls received a sugar pill.4 Botox’s pre-licensure trials lasted a median of 51 weeks and controls received a saline injection.5 And even with these long-term studies, drugs are still often recalled.
In contrast, vaccines are not required to undergo long-term double-blind inert-placebo controlled trials to assess safety. In fact, not a single one of the clinical trials for vaccines given to babies and toddlers had a control group receiving an inert placebo. Further, most pediatric vaccines currently on the market have been approved based on studies with inadequate followup periods of only a few days or weeks.
For example, of the two Hepatitis B vaccines licensed by the FDA for injection into oneday-old babies, Merck’s was licensed after trials that solicited adverse reactions for only five days after vaccination and GlaxoSmithKline’s was licensed after trials that solicited adverse reactions for only four days after vaccination.6 Similarly, the HiB vaccines sold by these same companies were licensed based on trials which solicited adverse reactions for three and four days, respectively, after vaccination.7 The only stand-alone polio vaccine was licensed after a mere 48- hour follow-up period. 8
Moreover, these trials either had no control group or a control group which received other vaccines as a “placebo.”9 This means each new vaccine need only be roughly as safe as one (or in some cases numerous) previously licensed vaccines. Such flawed and unscientific study designs cannot establish the actual safety profile of any vaccine. The real adverse event rate for a vaccine can only be determined by comparing subjects receiving the vaccine with those receiving an inert placebo. Yet, this basic study design, required for every drug, is not required before or after licensing a vaccine. The 1986 Act expressly requires that you, as the Secretary, “shall make or assure improvements in … the licensing … and research on vaccines, in order to reduce the risks of adverse reactions to vaccines.” (42 U.S.C. § 300aa-27(a)(2).)
Given this statutory obligation:
(1) Please explain how HHS justifies licensing any pediatric vaccine without first conducting a long-term clinical trial in which the rate of adverse reactions is compared between the subject group and a control group receiving an inert placebo?
(2) Please list and provide the safety data relied upon when recommending babies receive the Hepatitis B vaccine on the first day of life? III.
Post-Licensure Surveillance of Vaccine Adverse Events
The lack of pre-licensure safety data leaves the assessment of vaccine safety to the postlicensing period when they are being administered to children in the “real world.” To capture vaccine adverse events in the real world, the 1986 Act established the Vaccine Adverse Events Reporting System (VAERS) operated by HHS. (42 U.S.C. § 300aa-25.) In 2016, VAERS received 59,117 reports of adverse vaccine events, including 432 deaths, 1,091 permanent disabilities, 4,132 hospitalizations, and 10,284 emergency room visits.10
However, only a tiny fraction of adverse vaccine events are reported to VAERS. An HHS funded study by Harvard Medical School tracked reporting to VAERS over a three-year period at Harvard Pilgrim Health Care involving 715,000 patients and found that “fewer than 1% of vaccine adverse events are reported.” 11 A U.S. House Report similarly stated: “Former FDA Commissioner David A. Kessler has estimated that VAERS reports currently represent only a fraction of the serious adverse events.”12
Assuming VAERS captures a full 1 percent of adverse events – which is more than is estimated – the VAERS data above from 2016 may reflect that in that year alone there were 5,911,700 adverse vaccine events, including 43,200 deaths, 109,100 permanent disabilities, 413,200 hospitalizations, and 1,028,400 emergency room visits.
Of course, these figures are merely estimates. It would be far better if adverse events reports were automatically created and submitted to VAERS to avoid the issue of underreporting. Automated reporting would provide invaluable information that could clarify which vaccines might cause which harms and to whom, potentially avoiding these injuries and deaths.
The idea of automating adverse reaction reporting to VAERS is not new or even difficult to achieve. 13 An agency within HHS, the Agency for Healthcare Research and Quality, sought to do exactly that in 2007 when it provided an approximately $1 million grant to automate VAERS reporting at Harvard Pilgrim Health Care.14 The result was the successful automation of adverse event reports at Harvard Pilgrim: Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions … were identified.15 These results should have been concerning to HHS since they show that over only a three-year period, there were 35,570 reportable reactions in just 376,452 vaccine recipients.
After automating adverse events reports at Harvard Pilgrim, the developers of this system asked the CDC to take the final step of linking VAERS with the Harvard Pilgrim system so that these reports could be automatically transmitted into VAERS. Instead, the CDC refused to cooperate. As the Harvard grant recipients explained:
Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.16
After three years and spending $1 million of taxpayers’ money, the CDC refused to even communicate with the HHS’ Harvard Medical School grant recipients. Given HHS’s statutory mandate to assure safer vaccines, it should have rushed forward with automating VAERS reporting — not ignored the requests by the HHS’s Harvard grant recipients….
Vaccine whistleblower Dr. Suzanne Humphries blew even my mind recently: she believes vaccines have become a means of inducing chronic disease in order to profit from life long treatments. How obvious can this be? This is why I just wasn’t cut out to be a corporate CEO.