Gardasil, approved by the FDA (Food and Drug Administration) in 2006, is a Merck vaccine intended to prevent some strains of human papilloma virus.
Dr Bernard Dalbergue, formerly of Merck, predicts in the April 2014 issue of Principes de Santé (Health Principles) that “Gardasil will become the greatest medical scandal of all time because at some point in time, the evidence will add up to prove that this vaccine, technical and scientific feat that it may be, has absolutely no effect on cervical cancer and that all the very many adverse effects which destroy lives and even kill, serve no other purpose than to generate profit for the manufacturers.”
Time will tell.
Anyone with even a cursory interest in the subject of Gardasil, will be aware that the Japanese government withdrew its recommendation for cervical cancer vaccines after adverse events were suffered by young Japanese girls.
As reported in The Japan Times, “According to Dr. Sotaro Sato, who has examined many cervical vaccine victims, the convulsions, inability to walk, and involuntary hand and toe movements are being caused by encephalomyelitis, or the inflammation of the brain and spinal cord.
“Cervical cancer vaccines, which are chemically bound to special types of adjuvants, often trigger encephalomyelitis,” he said.
“Since the vaccines cause autoantibodies against the brain’s neuronal fibers to be produced in many cases, they have triggered demyelinating disorders,” he said, adding they have also induced many cases of cerebral vasculitis.
Cerebral vasculitis causes the body’s immune system to attack blood vessels in the brain, often leading to hemorrhaging, said Sato, who runs a hospital in Osaki, Miyagi Prefecture.”
It’s hard to imagine that any of this would be news to Dr Diane Harper, the principal investigator in the Gardasil trials.
“Diane M. Harper, MD, MS, MPH Director of the Gynecologic Cancer Prevention Research Group and Professor of Obstetrics and Gynecology, Community and family Medicine, and Informatics and Personalized Medicine at the University of Missouri–Kansas City School of Medicine. Dr. Harper reports that she has served as a speaker and advisor for Merck and GlaxoSmithKline, and that the institutions at which she conducted HPV vaccination trials have received funding from Merck and GlaxoSmithKline.”
During this discussion Dr Harper mentions that there is the potential for “ serious adverse events, including demyelinating diseases that cause blindness, paralysis, and death…”.
Dr Harper also states that “In the United States, the same women could choose a lifetime of Pap screening and be afforded the same protection against cervical cancer as they would get from vaccination.”
Something to consider
There are more than 100 types of HPV. At least 13 of these types of HPV are cancer-causing, according to the World Health Organisation. Gardasil contains only 2 of these – types 16 and 18 (along with types 6 and 11 for warts).
Dr Harper also made some very interesting points when interviewed by Marcia G. Yerman in 2009. (See full story here)
“Many vaccinated women have returned to me in clinic with more abnormal Pap tests and more HPV disease. They are tremendously disappointed when told that Gardasil does not protect against all types of HPV, and that they are still at risk for cervical cancer.
There is a real risk that cervical cancer will increase in the U.S. if those women getting Gardasil do not realize that:
• Gardasil will not protect them for life
• They can get other HPV infections that lead to cancer that are not covered by Gardasil
• They need to continue to have Pap tests throughout their lifetime.
Recent reports state that Gardasil may have triggered MS (Multiple Sclerosis) in some girls receiving the vaccine. What are your thoughts on this?
“Neurologists at the American Neurological Association have indeed concluded that Gardasil is temporally associated with autoimmune attacks on the neurologic system. The range of neurologic disorders is unknown.”
Do you believe that the Gardasil vaccine, as it currently stands, could present more risks to a young girl or woman than the possibility of cervical cancer?
“Pap smears have never killed anyone. Pap smears are an effective screening tool to prevent cervical cancer. Pap smears alone prevent more cervical cancers than can the vaccines alone.
Gardasil is associated with serious adverse events, including death. If Gardasil is given to 11 year olds, and the vaccine does not last at least fifteen years, then there is no benefit – and only risk – for the young girl. Vaccinating will not reduce the population incidence of cervical cancer if the woman continues to get Pap screening throughout her life.”
Has the original Gardasil marketing campaign of “one less” muddied the waters and misinformed the public, who heretofore believed that a Pap smear was sufficient to protect them from cervical cancer?
“If women were participating in Pap screening, or if as a parent you educated your daughter to seek Pap screening at the appropriate age (21 years) for her entire life, then she would have been very unlikely to be at risk for being “one” and would not be “one less.” She would not have been “one” to begin with!
Yes, the marketing campaign was designed to incite the greatest fear possible in parents, so that there would be uptake of the vaccine. If parents and girls were told the benefits and harms of Pap screening and HPV vaccines as described above, an informed and valued decision would have been able to be made. Many may have chosen to continue with a lifetime of Pap screening and forgo the vaccines, with the unknowns of duration of efficacy and safety unable to be answered for many more years.”
Can you point out specific “misstatements” that Merck has promulgated about the Gardasil vaccine?
“Less misstatements, than incomplete statements. For instance, the cumulative incidence of HPV infections for women in the U.S. through the age of 50 years old is 80%. That statement is true. That statement infers that nearly everyone is infected with HPV at least one point in their life.
What is left out is that 95% of all HPV infections are cleared spontaneously by the body’s immune system. The remaining 5% progress to cancer precursors. Cancer precursors, specifically CIN 3, progresses to invasive cancer in the following proportions: 20% of women with CIN 3 progress to invasive cervical cancer in five years; 40% progress to cervical cancer in thirty years. There is ample time to detect and treat the early precancers and early stage cancers for 100% cure.
Other examples include inferences that Gardasil will last a lifetime, with no mention of boosters or limited protection possible. Regarding wart protection promotion, there is no mention that the data showed protection against genital warts in men for only a 2.4-year period of time.
Gardasil is not really a cervical cancer vaccine. The vaccine prevents HPV infection, not the development of cervical cancer.”
Something else to consider
The Australian National Cervical Cancer Screening program information here indicates that “The biggest risk factor in cervical cancer is not being screened every two years, and that 3 out of 4 women who develop cervical cancer have either never had a Pap smear or haven’t had one in the past 5 years.”
It would seem that the real focus should be on further encouraging women to have their regular Pap tests, rather than encouraging a false sense of security in a vaccine covering only a couple of types of HPV.
Who yet knows whether Dr Bernard Dalbergue is correct when he says that Gardasil will be the greatest medical scandal of all time. What I do know is that if I check the Australian Therapeutic Goods Administration Database of Adverse Event Notifications, I can see that over 2,500 reports have been made about Gardasil so far in this country - and they include 9 cases of multiple sclerosis and 1 of blindness. As such sites as the TGA rely on passive surveillance, it is variously estimated that as few as 1-2%, or maybe up to 10% of cases are ever reported.
Would it even faze Merck if Gardasil did become the greatest medical scandal of all time? They will have surely by this time recouped their Vioxx scandal losses.
In my opinion, what definitely is a scandal at this current time is the way that children are being lined up like sheep to be given this vaccine at school in this country. The parents are provided with very little information – certainly no information that would allow them to make a true, informed choice. In my opinion, not only is that a scandal, it’s nothing short of an utter disgrace. In fact, it really gets to me.