August 15, 2008
By Leslie Carol Botha H. Sandra Chevalier-Batik
Why has there not been any mention of the potentially adverse effects of Merck’s cervical cancer vaccination, Gardasil® in relationship to the timing of the inoculation and where a young woman is in her menstrual cycle? This information is especially critical considering the vaccination is recommended for adolescent girls from the age of nine to young women up to 26-years.
Why is it that women are constantly forced into a male medical model which blatantly ignores their menstrual health and administers drugs, surgeries, and vaccinations without any regard to where they are in their hormone cycle?
This is outrageous. Even though women are asked to fill out the date of their last menstrual period (LMP) that information is used primarily to note that a woman is not pregnant. But it is much more valuable than that; the date of the LMP could actually be indicative of why that woman is in the doctor’s office to begin with.
Every cycling woman, who is aware of the changes that her body goes through prior to menstruation, knows that she is more prone to infections, colds, fatigue, irritability and a general feeling of malaise at this time. All of these issues are a direct result of hormonal changes that are cycling through her entire body, from the brain right on down to the uterus. Why haven’t the clinical researchers, FDA/CDC oversight committees, gynecologists, pediatricians or family practice physicians who have approved and administered Gardasil® considered how the injection of this chemical cocktail might affect a still maturing female body that is least able to defend itself during the paramenstrum?*
As the female hormone levels of estrogen and progesterone decrease during the premenstrual phase, the female body begins the process of releasing the uterine lining in the act of menstruation. The decrease in hormones actually affects a woman’s energy levels and her emotions. The immune system becomes more compromised, and that translates to a lowered defense system to fight off invading, foreign toxins.
Due to limited access to women’s menstrual health education, many women are totally unaware of the systemic aspects of their feminine hormone cycle. The medical, pharmaceutical industrial complex continues to ignore the premenstrual phase of menstrual cycle as a factor in testing and administration of drugs and vaccines. The only question women have to ask themselves is, “Is that policy based in ignorance, arrogance or methodical design?”
In her 1977 groundbreaking book, “The Premenstrual Syndrome”, Katharina Dalton noted that drug reactions “…are common during the premenstrum and may follow administration of antibiotics and inoculations. Confusion may occur as to the real origin of such reactions. In double-blind, clinical trials the placebo drugs are often reported to have side effects such as increased drowsiness, headache, nausea, or increased pain; which may be no more than the usual premenstrual symptoms which have not been meticulously observed and reported.” 1.
Dalton’s work is intriguing and her studies compelling. However, feminists dismissed the book and the author in the 1980’s, because the premise was considered damning to women suffering from premenstrual syndrome. And rightly so. Dalton stated in the preface to her book, “…In those days we believed that the premenstrual syndrome was a rare condition, but we know now that it is the world’s commonest, and probably oldest, disease.”2.
Classifying PMS as a disease provided the pharmaceutical and medical industry the leveraged justification that they skillfully exploited to extort billions of dollars from the systematic the medicalization of women’s bodies.
Fortunately, there is a growing body of clinical researchers, health practitioners, university professors, media professionals, feminists, and lay people who are beginning to realize that the menstrual cycle is not an illness or disease. Menstruation is becoming recognized as a natural cycle, that when understood and experienced holistically, could add healthy years to women’s lives.
Regrettably, Dalton’s work concerning premenstrual syndrome as it related to common drug reactions during the premenstruum was ignored — the issue denied; and many women have suffered in the past 40-years. The pharmaceutical, medical industrial complex filled the void of our self-knowledge and lack of understanding with calculated marketing campaigns that methodically exploited every aspect of a woman’s natural cycle.
SHAME, SHAME, SHAME ON BOTH INDUSTRIES
Gardasil®, as well as other immunizations
administered to adolescent women, are dispensed without regard to where a woman
is within her menstrual cycle. During Gardasil®’s,
clinical trial period, FDA approval, and during the two years it has
been on the market, not one article has been written about how a young woman
might tolerate the injection during premenstrum; nor is there any information in
the Patient Product Information or the Prescribing
Information on the Gardasil® web site, that cites any corollary
to adverse reactions to the injection in relationship to the menstrual cycle.
Withholding this information is nothing less than a crime against women
Earlier this month the Center for Disease Control (CDC) released report on the number of adverse reactions to Merck Pharmaceutical’s Gardasil® vaccine for cervical cancer. According to the report over 7,802 adverse events have been reported to the Vaccine Adverse Events Reporting System (VAERS) since 2006 when the controversial vaccine for cervical cancer was approved by the Food and Drug Administration (FDA) and introduced to the mass market. Since the 2006 approval, nearly 8-million adolescent girls and young women have currently received the Gardasil® vaccination.
While Wall Street reported Merck’s 1.5-billion dollar revenue3 windfall from the sale of the Gardasil®, fifteen deaths and two lawsuits are amongst the nearly 8,000 reports, according to the CDC. On August 14, 2008 the National Vaccine Information Center (NVIC) sent out an email blast with more shocking statistics; there are now 17 – 20 confirmed deaths. On July 22, 2008, The Board of Directors of Merck & Co., declared a quarterly dividend of $0.38 per share on the Company’s common stock for the fourth quarter of 2008.
If one does the quick math, it becomes obvious that nearly 10% of the women who received the Gardasil® vaccination experienced an adverse reaction. In our humble opinion, that is an incredibly high percentage. Add that to the number of unknown and unreported incidents of an adverse reaction to Gardasil®, and the percentage could actually be far greater. David Kessler, former Commissioner of the FDA reported in an article in JAMA – June 2,1993, Vol. 269, No.21; “…it is estimated that only between 1-10% of immunization events are reported to the Vaccine Adverse Events Reporting System;” a figure supported by two NVIC investigations.
NVIC also reported that “In New York, only one out of 40 doctor’s offices or 2.5% confirmed that they report a death or injury following vaccination” leaving 97.5% of vaccine related deaths and disabilities unreported.
The percentage of adverse reactions to Gardasil® could indeed, be significantly higher than researchers have estimated.
Women should be Angry — Women need to take Action
The endocrine system is responsible for releasing hormones into the bloodstream. This process regulates body functions, including growth and development, immune system function, responses to stress and other emotions, basal metabolic rate, and sexual reproduction. Girls begin to secrete hormones up to two years prior to their first period. When these hormones are prevalent a young woman’s body is at its peak. However, the ebb and flow of these secretions of hormones into the bloodstream is erratic until the menstrual cycle regulates itself. On average, it takes three to four years for a regular menstrual cycle to develop.
Our young, innocent daughters are being subjected to a mass vaccination program at an age when they are most vulnerable — mentally, emotionally and physically. Their bodies and their emotions are susceptible to additional external stimulus – like the administration of aluminum and foreign antibodies into their systems.
As the menstrual cycle begins to mature, just like the young women, the secretions of hormones become more stable – so that the high and low points in a woman’s hormone cycle are more discernable, especially if a woman is charting her cycle.
When one thinks about this – it makes sense; common sense. But this information is not new – actually Glamour Magazine printed this small piece about natural rhythms and timing of breast cancer surgery in the early 1990’s:
“Keeping in step with your body’s natural rhythms could add years to your life, especially if you are one of the 40,000 to 50,000 pre-menopausal women who will face breast cancer surgery this year. According to a recent Lancet study report on a twelve year study of forty-one women with breast cancer, those whose surgery is performed near the times of ovulation are four to five times less likely to suffer relapse and death than those who are operated on during or nearer their menstrual period.”
Why the dramatic difference? Researcher William J.M. Hrushesky, M.D., senior oncologist at the Albany VA Medical Center in Albany, N.Y.speculates that a woman’s immune defenses are likely to vary with her menstrual cycle and may become most potent with ovulation. So her ability to fight disease may be significantly higher at that point of her cycle.”
So there you have it. Numerous studies have been completed, research conducted and documented. The pharmaceutical, medical industrial complex is aware of the findings that indicate that the cyclic nature of women’s periods should be a factor in the timing of medication and other medical procedures. Yet, such considerations have not been published in medical journals, pharmaceutical trade magazines or the general media. Women have been effectively kept in the dark about their own bodily rhythms. If all women understood their natural feminine cycles, we would know enough to refuse the plethora of pharmaceuticals being pushed on us by the drug lords – we call our family doctors. Legal drugs or illegal drugs – they are all drugs – and they are the foundation of a trillion dollar industry that would implode if women had reliable menstrual health education.
There have also been studies about the cyclical nature of the hormone cycle in relationship to women’s health. McCall’s Magazine reported on one of these studies in a 1993 issue. This mention – which we call an “Oh, by the way” – should have made world headline news.
“While most women hardly need to be told that their hormone cycle affects their body; few of us suspected it could make the difference between life and death. But research with breast-cancer patients is starting to suggest that scheduling a patient’s surgery according to her cycle may increase her chances of being cured. And that’s just the most prominent example to emerge from a small but growing exploration of the relationship between women’s monthly hormonal changes and common illnesses, ranging from migraines to irritable bowel syndrome.”
Another study conducted from 1998 – 2001, titled: Timing of Breast Cancer Surgery, Menstrual Cycle and Prognosis, published by researchers from the University of California, San Diego- Department of Family and Preventive Medicine; University of California, Los Angeles- Revlon/UCLA Breast Center; University of California, Los Angeles- Division of Oncology also cites that the timing of a woman’s menstrual cycle is crucial to the prognosis of her breast cancer surgery.
Upon contacting the authors of the study we asked why they did not try to get media attention for their findings. The researchers responded that they did indeed attempt to contact the media, but neither they nor the medical industry expressed interest.
There is enough solid research available to insist that the menstrual cycle phase be taken into consideration whenever any drug or vaccine is administered to lessen the potential adverse reaction for menstruating women of all ages.
Once again, industry knows – but women do not. Shame. Shame. Shame.
ADVERSE REACTIONS
It is possible and probable that some of the adverse reactions to the Gardasil® vaccine are due to the shot being administered during the paramenstrum. It is also possible and probable that some of the adverse reactions to the vaccination may be hormonally related to the premenstrual phase – and not due to the vaccination.
Based on the current research and the unacceptable number of adverse reactions and unexplained fatalities “coincidentally” related to the Gardasil® inoculations, it would behoove Merck Pharmaceuticals to include menstrual cycle evaluation with the overall guidelines in the Gardasil® Patient Product Information and the Prescribing Information. For that matter, every pharmaceutical company producing and marketing drugs to women should also have this information in their product and patient information.
WOMEN ARE CYCLING BEINGS, NOT BEINGS AT THE MERCY OF A CYCLE
Women must declare dominion over our bodies and those of our daughters and granddaughters. We must become aware of how our hormone cycle affects our mental, emotional and physical health. It is past time to, not only reclaim our bodies – but our menstrual cycles, our health and well being.
Women must not remain passive, compliant, victims of an industry that does not have our physical and emotional well being as their prime objective. Women and girls are not simply profit centers, to be maximized for increased stockholder share. For the love of our mothers and daughters, our sisters and wives, each of us must become medically savvy activists focused on ending pharmaceutical and medical crimes of omission against women and our children.
*Paramenstrum includes the premenstrual and menstrual phase.
*Premenstruum is the British term for premenstrual at least as referenced by Katharina Dalton
1. Dalton, K., M.R.C.G.P, 1977, The Premenstrual Syndrome, 5.49
2. Dalton, K., M.R.C.G.P, 1977, The Premenstrual Syndrome, Preface
3. MERCK Annual Review 2007 10-K 2007, Pg 58
Total sales as recorded by Merck for Gardasil® are $1.7 billion in 2008 (up from $1.5 in 2007.) Sales included initial purchases by many states through the U.S. Centers for Disease Control and Prevention (“CDC”) Vaccines for Children program, compared with $234.8 million in 2006. Gardasil® was approved by the FDA in June 2006 and is the only approved vaccine in the United States to help prevent cervical cancer, pre-cancerous and low-grade lesions, vulvar and vaginal pre-cancers, and genital warts caused by HPV types 6, 11, 16 and 18. Gardasil® was approved for use in the EU in September 2006. Gardasil® is a three dose, intra muscular vaccine given over six months, approved for 9- to 26-year-old girls and women. By the end of 2007, Gardasil® was approved in 93 countries, many under fast-track or expedited review, with launches under way in 76 of those countries. The vaccine remains under review in approximately 40 other countries and territories. The Company is a party to certain third party license agreements with respect to Gardasil® (including a cross-license and settlement agreement with GSK). As a result of these agreements, the Company pays royalties on worldwide Gardasil®sales of approximately 24% to 26% in the aggregate, which are included in materials and production costs.
How has Gardasil® helped the bottom line of MERCK stockholders?
Common Stock Market prices before the release of Gardasil®
1st quarter 2006 — $31.81
4th quarter 2007 — $61.62
Leslie Botha
Nationally Recognized Expert on Women’s Health
Author, Publisher, Radio Talk Show Host,
Women’s Menstrual Health Educator,
Member of the Society for
Menstrual Cycle Research
Advisory Board Member For
The Foundation for the Study of Cycles
2006 Recipient of the Edward R. Dewey Award
“Holy Hormones Honey – The Greatest Story Never Told!”
H. Sandra Chevalier-Batik
Women’s Health Research Analyst
Author, The Inconvenient Woman Blog
Co-Author, Holy Hormones Honey – the Greatest Story Never Told!