Dear Ms. Stephens,
Thank you for your response to my recent inquiry into the safety and effectiveness of the HPV vaccine, Gardasil. I have studied your letter thoroughly and frankly, am somewhat disturbed by the fact that your response gives rise to more questions than answers.
The following quotes from your letter raise these questions:
“The Vaccine Adverse Event Reporting System (VAERS) is subject to many limitations…..”
If these ‘limitations’ are known, why are they not being addressed and remedied?
“There is a lack of a direct, concurrent, and unbiased comparison group.”
Is this not the purpose of conducting clinical trials, to establish and monitor a proposed vaccine under a ‘direct, concurrent, and unbiased comparison group’ situation? If clinical trials are designed to test the safety and efficacy of proposed vaccines, why was Merck not made to use a true placebo while conducting their clinical trials on Gardasil?
“FDA and the Centers for Disease Control and Prevention (CDC) use VAERS to identify potential safety signals…..”
Is not over 100 reports of adverse events per week a ‘potential’ safety signal? Is 28 deaths within 30 days of HPV vaccination not a ‘potential’ safety signal?
“To evaluate whether or not the vaccine causes an adverse effect, various types of epidemiologic studies are conducted.”
In addition to epidemiology, are any tests or medical evaluations done in an attempt to determine whether the vaccine did cause the adverse events?
“The rate at which adverse events are reported to VAERS is often described by the number of adverse event reports received, divided by the number of vaccine doses distributed.”
Even the most uneducated can see this calculation skews information in favor of the vaccine manufacturer. This is particularly true in the case of a vaccine, such as Gardasil, where three doses are recommended. How many of these ‘distributed’ doses are in storage awaiting administration at any given time?
In order to provide a more accurate picture, why are adverse events not calculated by the number of doses actually administered? In the case of HPV vaccines, why are they not calculated by the number of girls who received one, two, or all three doses?
“In addition, some of the Phase 4 post-marketing studies are conducted in other countries. Many small countries do not have the infrastructure to conduct safety surveillance.”
Why does the FDA accept the results from post-marketing studies which have been conducted in countries that cannot conduct adequate safety surveillance?
“To date, we do not have scientific evidence that the vaccine caused these events.”
I would respectfully submit that neither do you have scientific evidence that the vaccine did not cause these events.
“We continue to review all serious reports daily, and we do analyses to evaluate potential safety signals.”
Exactly what type of ‘analyses’ does the FDA conduct to evaluate potential safety issues? Your letter provided no evidence of such analyses.
According to an article published in ‘The Journal of the American Medical Association (Aug 2009), “From June 1, 2006, through December 1, 2008, VAERS received 12,424 reports of adverse AEFI’s following receipt of qHPV (TABLE 1), an overall reporting rate of 53.9 reports per 100,000 vaccine doses distributed. The majority of reports (8471/12,424, or 68%) were submitted by the manufacturer, compared with an overall rate of 40% for VAERS reports on other vaccines.
During the same time period, manufacturer reports accounted for 14.5% of the meningococcal conjugate vaccine reports and 7.5% of the reports for tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine submitted to VAERS. Of the 8471 manufacturer reports for qHPV AEFI’s, 7561 (89%) had insufficient identifying information to permit clinical follow-up or review.”
Has the FDA taken any steps to require the manufacturer to provide adequate information on future VAERS reports?
Does the FDA examine other countries’ databases regarding serious adverse events and death reports? For example, The Paul Ehrilich Institute in Germany reported 5 fatalities following HPV vaccination. Are these reports included in VAERS?
Does the FDA examine reports from the World Health Organization adverse events database?
In reference to study 013, your letter said, “These underlying risk factors can skew the results.”
Do these underlying risk factors not exist in the general population also? Do they not ‘skew’ the effectiveness of the vaccine? Should people with these ‘underlying’ risk factors not be excluded from vaccination as a safety precaution?
Also in reference to study 013, you stated, “Other large trials have not replicated the results of the aforementioned analysis.”
Is it not true that these results have not been replicated because other large trials have not examined those cohorts of the population?
When questioned about reports linking HPV infections to other types of cancer, you responded with the statement, “HPV 16 and HPV 18 and other oncogenic HPV types are recognized as carcinogenic biologic agents by internationally recognized experts……..”
Are not many of the ingredients in Gardasil also recognized as either carcinogenic, neurogenic, or hazardous waste by internationally recognized experts, including other regulatory agencies such as the EPA?
When asked why the FDA believes HPV vaccines are safe for administration to adolescents and how the FDA justifies a vaccination program for all adolescent girls based on low cervical cancer incidence rates, your response completely sidestepped the safety issue and went on to indicate other government agencies responsible for making advice regarding vaccination schedules.
Since it is the FDA’s responsibility to approve vaccines based on effectiveness and safety, the question remains… Why does the FDA believe HPV vaccines are safe for administration to adolescents?
In view of the fact the FDA is a science-based, science-driven regulatory agency whose stated mission is to promote and protect the health of the public, Congress and the American public has a right to know the organization is doing that job. Please provide science-based answers to the questions in this letter.
In closing, my recommendation for an independent study analyzing the safety and efficacy of HPV vaccines be performed still stands.
Congressman Charlie A. Wilson