November 21, 2008
One of the things that I like to do is run numbers. I will take an excel spreadsheet and enter in the data that I am researching. Then I will put in the formulas to generate statistics for the data that I am working with at the time. Today I am going to do just that using the updated VAERS reports from September 2008.
First I wanted to see how many doctors did not get the memo about multiple vaccinations in conjunction with Gardasil.
7.1 Use with RECOMBIVAX HB
Results from clinical studies indicate that GARDASIL may be administered concomitantly (at a separate injection site) with RECOMBIVAX HB hepatitis B vaccine (recombinant) [See Clinical Studies (14.6)]. Co-administration of GARDASIL with other vaccines has not been studied.
Presently I have found 14015 reports to VAERS. Out of those reports we have 2195 reports that mention multiple vaccines given. That means 16% of the doctors did not get that memo. I wanted to know why so I went to the Merck website and found this.
The title of the page is “Don’t Miss an Opportunity to Vaccinate”. This section comes under the heading of “Girls in your practice.”
Patients visit your office for many reasons:
Back-to-school checkupsTeam sports physicalsRoutine adolescent health care visitsThese visits can be an ideal time to vaccinate.
The human papillomavirus (HPV) vaccine is on the ACIPa (aACIP=Advisory Committee on Immunization Practices.) adolescent immunization schedule.b (AAP=American Academy of Pediatrics. Provisional recommendation. A full policy statement is forthcoming.)
The next section is “Young women in your practice.”
Patients visit your office for many reasons:
Annual physical examsPap tests, birth control, and other preventive health care needsRoutine patients’ visits can be an ideal time to:
Discuss human papillomavirus (HPV) and cervical cancer (According to American College of Obstetricians and Gynecologists.)
Offer vaccination to appropriate patients (Provisional recommendation. A full policy statement from the AAP is forthcoming.)
A doctor is going to look at these recommendations and think that it is okay to administer Gardasil along with the other vaccines recommended in the adolescent immunization schedule and the recommended adult vaccines like the flu vaccine.
Now to me this just contradicts totally what is said in the doctors product information sheets that they get. It also makes me wonder if these doctors even bothered to read this information at all. This document is 19 pages long and probably pretty boring reading to the doctors but don’t they take an oath to “do no harm”? With this oath I would assume that they would feel compelled to read every new product sheet that they get? That is my opinion.
These are some numbers that I wish I had. There is a page called the “Dose Replacement Program for Gardasil at DRP4GARDASIL.com”.
“Program participants are eligible to receive Replacement doses of Gardasil when a dose is administered to a 19 – 26 year old privately insured patient and the participant later learns that the patient’s private insurance provides no reimbursement for the vaccine.”
So this means that the doctor can charge the individual for the vaccine and still get a dose free as long as the patient has private insurance. If you do not have insurance you pay. I wonder how many free doses the doctors got from this program.
Just to get an idea of how much money we could be talking about here let us say there are 10 patients in a practice that have private insurance that does not cover the shots. We know that the shots cost $360 for a series. That means the individuals are going to pay the doctor $3600 + $1350 ($45 X 3 visits X 10 patients) = $4950. Now add the free vaccine that the manufacturer is going to provide $3600 + $4950 = $8550 this doctor just made from 10 patients.
Thought provoking isn’t it.
Now here is another set of numbers that I found interesting. I received information from a third party about a conversation that was had with a Merck insider. I am waiting for validation from the person who had the conversation. For arguments sake let us just say that the possibility is true. The conversation revealed that there are over 20,000 reported adverse events to Merck.
From the United States enumerated census for 2000 we have 38,695,524 females in the age range of 10 -29. It has been reported that 10 to 20% have received at least one dose so the average is 15%. That means that 5,804,329 young woman have been vaccinated. If you have 20,000 reported adverse events out of 5,804,329 young women that means you have a 3.5% likelihood of having an adverse reaction. It is my opinion I would like to see the percentage down to 0% but in the studies they state this.
Out of the entire study population (25,274 subjects), only 0.05% of the reported serious systemic adverse reactions were judged to be vaccine related by the study investigator. You need to remember that the study investigator was paid by Merck.
A 3.0% difference in adverse reactions is pretty huge to me in these post marketing studies our girls are participating in without their consent.
6.2 Post-Marketing Experience
The following adverse events have been spontaneously reported during post-approval use of GARDASIL. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
Blood and lymphatic system disorders: Autoimmune hemolytic anemia, lymphadenopathy.
Gastrointestinal disorders: Nausea, pancreatitis, vomiting.
General disorders and administration site conditions: Asthenia, death, fatigue, malaise.
Immune system disorders: Autoimmune diseases, hypersensitivity reactions including
anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Dizziness, Guillain-Barré syndrome, headache, motor neuron disease, paralysis, seizures, syncope sometimes resulting in falling with injury, transverse myelitis.
Vascular Disorders: Deep venous thrombosis, pulmonary embolus.
I have talked to parents of girls that are being diagnosed with these symptoms. But still this vaccine is said to be totally safe by Merck, the FDA and the CDC. Personally I do not think that a once healthy active young woman should take the 3.5% chance of having pancreatitis, myalgia, Guillain-Barre syndrome, paralysis or seizures. To me that is like playing Russian roulette.
7.2 Use with Hormonal Contraceptives
In clinical studies, 13,293 subjects (GARDASIL N = 6644; AAHS control or saline placebo N = 6649) who had post-Month 7 follow-up used hormonal contraceptives for a total of 17,597 person-years (65.1% of the total follow-up time in the studies). Use of hormonal contraceptives or lack of use of hormonal contraceptives among study participants did not alter immune response in the per protocol efficacy (PPE) population.
What I find interesting here is that the only thing that is mentioned is about the immune response. I did some digging and did not find any studies about blood clotting possibility when getting the shot in conjunction with birth control. So I am going to assume that no studies were done in that arena. But then again you do have them saying under Vasscular Disorders: Deep venous thrombosis and pulmonary embolus. (blood clots)
7.3 Use with Systemic Immunosuppressive Medications
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic
drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune responses to vaccines [See Warnings and Precautions (5.1)].
Here again they only mention the immune response. Here are some excerpts from the history section of only a few of the reports. I guess the doctors did not get this memo either. Here these young women received the vaccine and in my opinion they should not have.
10/6/08-records received-PMH:end stage liver disease secondary to autoimmune hepatitis and EBV hepatitis. Increasing fatigue and weight gain over last several years, leg swelling and yellowing of eyes.
7/21/08-records received-PMH:scoliosis. Seasonal allergies. Diagnosed with PTC March 2007 well controlled until day of admission.
Allergy to Morphine. History of Necrotizing Fasciitis - 6/04, Toxic Shock 5/04. PMH: obesity, irregular menstrual cycle, otitis media, URI, lead exposure, toxic shock syndrome, eczema. Hospitalized 4/04 for necrotizing fasciitis of right
I am going to bring this up again.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity.
My impression from everything that I have read is that Merck was only interested if their vaccine was effective against HPV. Which, according to their studies it is true. It is my opinion that little was done to determine via research to check into the blood clots and other potential life threatening events in the vaccine. It is my opinion that this vaccine is not safe and it would bring me to question the safety of any vaccine with such a laundry list of side effects.
We need to make our vaccines safe for our children and for all adults before we administer any more.
To look at the information that I cited go to these links by Merck. This is the information that is given to the doctors and the patients.
Let us play with the Gardasil numbers
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Cynthia Janak
