The Trouble With Gardasil, Fully Informed Consent and the Number Needed to Vaccinate

 

The Trouble With Gardasil, Fully Informed Consent and the Number Needed to Vaccinate

By Gary G. Kohls, MD, guest to Natural Blaze

9,080 sexually-inactive young women have to be vaccinated in order to prevent just 1 case of cervical cancer

FACT: Vaccine-administering and vaccine-profiting pediatricians, physicians, nurses and/or clinics NEVER explain the pros and cons of vaccinations to parents of babies and children before the vaccines are injected into their muscles. How can this be when it is both a legal and ethical obligation of every health caregiver to obtain fully-informed consent from the patient or patient’s legal guardian before any procedure, vaccination or drug treatment is administered.

Here is what Merck’s Gardasil product information sheet says about the limitations, risks, dangers about Gardasil. This is information that the parents of young women need to know before the shots are started.

Limitations of GARDASIL

The health care provider should inform the patient, parent, or guardian that vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.

Use and Effectiveness:

GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.

Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider.

GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.

GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal, and anal cancers.

GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine

Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal, and anal cancers caused by HPV 16 and 18.

GARDASIL does not protect against genital diseases not caused by HPV.

Vaccination with GARDASIL may not result in protection in all vaccine recipients.

GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age.

WARNINGS AND PRECAUTIONS

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position. (5.1)

Clinical Trials Experience

29,323 total patients were in the trials.

15,706 were in the GARDASIL group

13,023 were in the so-called AAHS group (that deceptively contained an aluminum adjuvant-and was therefore NOT a true placebo and

594 were in the legitimate saline placebo group

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

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Studies in Girls and Women (9 Through 45 Years of Age) and Boys and Men (9 Through 26 Years of Age)

In the 7 GARDASIL clinical trials, 5 of them used the neurotoxic adjuvant Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS] as a so-called “control” group (actually a pseudo-control group), one trial used a saline placebo-control, and 1 trial was uncontrolled).

18,083 individuals were administered GARDASIL, AAHS or saline placebo on the day of enrollment, and approximately 2 and 6 months thereafter, for a total of 3 intramuscular injections. Safety was evaluated using vaccination report cards for [only] 14 days after each injection!

Serious Adverse Reactions in the Entire Study Population Across the clinical studies

258 individuals out of a total of 29,323 had serious adverse reactions

128 or 0.8% were in the GARDASIL group of 15,706 patients and

130 or 1.0% out of 13,023 were in the AAHS group

No serious adverse reactions occurred in the 594 patients that were in the saline placebo group

ADVERSE REACTIONS

The most common adverse reaction was headache. Common adverse reactions (frequency of at least 1.0% and greater than AAHS Control (Amorphous Aluminum Hydroxyphosphate Sulfate) or saline (no aluminum) placebo) are fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising. (6.1)

Serious Adverse Reactions in the Entire Study Population Across the clinical studies

Headache; Gastroenteritis; Appendicitis; Pelvic inflammatory disease; Urinary tract infection; Pneumonia; Pyelonephritis; Pulmonary embolism; bronchospasm; asthma were reported as serious systemic adverse reactions that occurred following any vaccination visit.

Deaths and Serious Illnesses in the Entire Study Population Across All Clinical Studies

40 deaths occurred; 21 in the (GARDASIL group; 19 in the AAHS “Control” group and ZERO deaths occurred in the saline placebo group

The Merck GARDASIL insert reported that “The events reported were consistent with events expected in healthy adolescent and adult populations.”

Motor vehicle accidents accounted for 5 deaths in the GARDASIL group and 4 deaths in the AAHS “control” group);

Drug overdose/suicides accounted for 2 deaths in the GARDASIL group and 6 deaths in the AAHS group;

Gunshot wounds caused death in 1 patient in the GARDASIL group and 3 deaths in the AAHS group and

Pulmonary embolus/deep vein thrombosis caused 1 death in the GARDASIL group and 1 death in the AAHS group.

In the group that received GARDASIL there were 2 cases of sepsis, 1 case of pancreatic cancer, 1 case of arrhythmia, 1 case of pulmonary tuberculosis, 1 case of hyperthyroidism, 1 case of post-operative pulmonary embolism and acute renal failure, 1 case of traumatic brain injury/cardiac arrest, 1 case of systemic lupus erythematosus, 1 case of cerebrovascular accident, 1 case of breast cancer, and 1 case of nasopharyngeal cancer;

In the AAHS control group there was 1 case of asphyxia, 1 case of acute lymphocytic leukemia, 1 case of chemical poisoning, and 1 case of myocardial ischemia;

In the saline placebo group there was 1 case of medulloblastoma.

Systemic Autoimmune Disorders in Girls and Women 9 Through 26 Years of Age

In the clinical studies, 9- through 26-year-old girls and women were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received GARDASIL or AAHS Control (= Amorphous Aluminum Hydroxyphosphate Sulfate control) or saline placebo are shown in Table 9. This population includes all girls and women who received at least one dose of GARDASIL or AAHS control or saline placebo, and had safety data available.

Arthralgia/Arthritis/Arthropathy; Autoimmune Thyroiditis; Celiac Disease; Diabetes Mellitus Insulin-dependent; Erythema Nodosum; Hyperthyroidism; Hypothyroidism; Inflammatory Bowel Disease; Multiple Sclerosis; Nephritis; Optic Neuritis; Pigmentation Disorder; Psoriasis; Raynaud’s Phenomenon; Rheumatoid Arthritis; Scleroderma/Morphea; Stevens-Johnson Syndrome; Systemic Lupus Erythematosus; Uveitis.

Postmarketing 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; idiopathic thrombocytopenic purpura; lymphadenopathy;

Respiratory, thoracic and mediastinal disorders:

Pulmonary embolus.

Gastrointestinal disorders:

Nausea; pancreatitis; vomiting.

General disorders and administration site conditions:

Asthenia; chills; 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: Acute disseminated encephalomyelitis; dizziness; Guillain-Barré syndrome; headache; motor neuron disease; paralysis; seizures; syncope (including syncope associated with tonic-clonic movements and other seizure-like activity) sometimes resulting in falling with injury transverse myelitis.

Infections and infestations: cellulitis.

Vascular disorders: Deep venous thrombosis.

Based on the assumption that Gardasil immunity would wane at a rate of 3%/year (probably an unrealistic assumption) following the initial intramuscular injection of the (neurotoxic) aluminum-containing vaccine and assuming that its efficacy is 95% (also probably unrealistically optimistic), 9,080 sexually-inactive young women would have to be vaccinated in order to prevent just 1 case of cervical cancer (ie, the Number Needed to Vaccinate (NNV) would be an astronomical 9,080!).

For varicella (chickenpox) vaccination, we estimated that 34 000 people would need to be vaccinated to prevent 1 death (using mortality rates reported by Brisson and Edmunds25 and assuming 100% efficacy against the varicella-zoster virus and no waning in protection).

To prevent 1 meningococcal-related death, we estimated that about 21 000 people would need to be vaccinated (using mortality data reported by De Wals and associates26 and assuming 100% efficacy against types A, C, Y and W135).

Finally, we estimated that 5000 people would need to be vaccinated to prevent 1 death from influenza

BASICS OF THE NNT MEASURE

The NNT is based on the frequency of disease outcome measured as a cumulative incidence of the outcome per number of patients followed over a given time period. This will result in a proportion of patients with the outcome, which we mechanically tend to write as a percentage, such as 0.5/100, 2/100, or 5/100, to make frequencies easily comparable.

Instead of using percentages to facilitate comparisons, we could alternatively express the proportions by fixing the numerator at 1. In our example these become 1/200, 1/50 and 1/20, which when inverted to 200:1, 50:1, and 20:1 represent the number of patients that need to be observed to find one patient with the outcome. This reversed representation of the proportion forms the basis for the NNT.

The NNT relates to the effectiveness of a treatment, usually based on a randomized or observational trial comparing two treatment alternatives, measured by the treatment difference in the proportion of patients with the adverse disease outcome over a fixed follow-up time-period. This difference will represent the proportion of patients for whom the adverse outcome was prevented due to treatment. Inverting this difference will produce the number of patients that need to be treated to prevent one patient with the outcome.

The following Canadian Medical Journal article states that if the immunological (but not cellular) protection from cervical cancer that Gardasil is theorized to produce – which has not been proven – wanes at a rate of 3% per year (an optimistic projection) and is 95% “effective” (another overly-optimistic projection), 9,080 women will have to be fully inoculated in order to prevent just 1 woman from getting cervical cancer. (Effectiveness means that the vaccine  elicits sufficient antibodies to the genetically-engineered, synthetic antigens that are in the vaccine, which are actually NOT viral antigens).

In other words, according to the medical journal article below, 9,079 women of the young women who paid for ($400+ for the series of three shots, plus hundreds of dollars more for the office call fees) and were intramuscularly injected with the vaccine ingredients (many of which are toxic) will not be protected from acquiring cervical cancer.

But many of them will be seriously sickened or even killed by the vaccine’s neurotoxic ingredients, particularly the aluminum nanoparticles that, when such toxic metals are injected in a living animal’s muscle tissue, can cause many maladies, notable autoimmune disorders, chronic fatigue syndromes, POTS, Guillain-Barre Syndrome, etc, etc.

__________________________________________________________________________

Estimating the Number Needed to Vaccinate (NNV) to Prevent Diseases and Death Related to Human Papillomavirus (HPV) Infection

Marc Brisson, PhD, Nicolas Van deVelde, MSc, Philippe DeWals, MD PhD, and Marie-Claude Boily, PhD

Ed Note: The short excerpt below comes from a Canadian Medical Association Journal (CMAJ) article. Keep in mind that three of the four authors (all except for Van deVelde) have serious conflicts of interest due to their financial ties to the multinational Big Pharma corporation Merck and other pharmaceutical companies. And yet, despite their obvious conflicts of interest, the statistics they present provide strong reasons (which may be underestimates!) to actually refute the claims of Merck that Gardisil is an effective vaccine.)

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1950193/

www.cmaj.ca/cgi/content/full/177/5/464/DC1

The number needed to vaccinate is the number of women (within a specific age cohort) who would need to be vaccinated in order to prevent a single HPV-related event during their lifetime. The number needed to vaccinate (NNV) is calculated as follows: NNV = N ÷ P, where N is the size of the vaccinated cohort, and P is the predicted number of HPV-related events prevented in the vaccinated cohort over its lifetime. In the case of the number needed to vaccinate to gain a life-year, we divided the size of the vaccinated cohort by the total number of life-years gained in the cohort by preventing deaths from cervical cancer. Results are expressed as the mean and 80% credibility interval (10th and 90th percentiles) of the 209 simulations. 

The number needed to vaccinate was calculated as the number of women who would need to be vaccinated to prevent an HPV-related event during their lifetime.

Results

Among 12-year-old girls, we estimated that the number needed to vaccinate to prevent an episode of genital warts would be 8 (80% credibility interval [CrI] 5–15) and a case of cervical cancer 324 (80% CrI 195–757). These estimates were based on the assumption that the vaccine procures lifelong protection and that its efficacy is 95%. If vaccine protection is assumed to wane at 3% per year, the predicted number needed to vaccinate (to prevent genital warts) would increase to 14 (80% CrI 6–18) and (the predicted number needed to vaccinate to prevent one case of cervical cancer would be) 9,080.<<snip>>

To put the results of our analysis into perspective, we compared the HPV vaccine with 3 other vaccines (varicella, meningococcal and influenza vaccines) in terms of the number needed to treat to prevent 1 death.

For varicella (chickenpox) vaccination, we estimated that 34 000 people would need to be vaccinated to prevent 1 death (using mortality rates reported by Brisson and Edmunds25 and assuming 100% efficacy against the varicella-zoster virus and no waning in protection).

To prevent 1 meningococcal-related death, we estimated that about 21 000 people would need to be vaccinated (using mortality data reported by De Wals and associates26 and assuming 100% efficacy against types A, C, Y and W135).

Finally, we estimated that 5000 people would need to be vaccinated to prevent 1 death from influenza (assuming the vaccine is given to people aged 65 or more). These results are higher than our estimates for the prevention of a death from cervical cancer with HPV vaccination when we assume that the duration of protection is lifelong or that a booster dose is given to women with waning vaccine-induced immunity.

However, if vaccine protection is assumed to wane at 3% per year (mean protection 30 years, efficacy 95%), the estimated number needed to vaccinate with HPV vaccine is unlikely to be lower than those for varicella, meningococcal and influenza vaccines. <<snip>>

The long-term efficacy for a new vaccine is usually unknown owing to the relatively short duration of clinical trials. Current studies suggest that HPV vaccines used for prophylaxis are highly effective for at least 5 years and that there is no evidence of waning efficacy during that period. However, the long-term duration of vaccine-induced immunity remains unclear. Given the importance of the duration of protection on the effectiveness of HPV vaccination, post-vaccination surveillance of waning efficacy is essential.

If the protection of the HPV vaccine does wane substantially, booster shots will likely be required to maintain and lengthen vaccine-induced immunity. Our model predicts that a booster dose would significantly reduce the number needed to vaccinate and would increase the effectiveness of HPV vaccination if waning occurs. However, uptake (coverage) of the booster dose would probably be lowest among women who would need it the most, because they will likely be the same women who are not regularly screened for cervical cancer.

The main limitation of our study is that the model does not account for herd-immunity effects. Previous modelling studies have predicted that, if coverage rates are high, vaccination will produce positive herd-immunity effects. Hence, if high coverage rates are attained (which would be expected in Canada with routine immunization), the population-based number needed to vaccinate will likely be lower than the estimates in our study. On the other hand, if coverage rates are low or if our estimates are applied only to those who are vaccinated, accounting for herd-immunity effects will have little or no effect on predictions. Our estimates should be generalized only to settings or countries with similar HPV epidemiologic data, because the estimates are dependent on the age-specific background rates of disease. Another limitation is that the number needed to vaccinate was calculated from mean population rates of HPV infection and disease. Hence, it may not represent subgroups within Canada that have different HPV epidemiology and screening rates (e.g., high-risk groups). Finally, we focused on the number needed to vaccinate to prevent an episode of genital warts, a case of cervical intraepithelial neoplasia and a case of cervical cancer because they are currently the most important HPV-related diseases in terms of death and use of health care resources. However, for a complete picture of the potential benefits of HPV vaccination, one should include the predicted number needed to vaccinate to prevent other anogenital cancers, head and neck cancers, and recurrent respiratory papillomatosis.

The main strength of our study is that we performed an extensive fitting procedure and identified multiple parameter sets that reproduced available epidemiologic data, which allowed us to illustrate the uncertainty around model predictions. The wide credibility intervals when efficacy is assumed to wane or vaccination is given to “older” women reflect the uncertainty in the natural history of HPV in older adults and suggest that more research is needed in this area. Although challenging owing to the lack of long-term data, more studies should be focused on quantifying the rate of waning protection following vaccination.

In summary, our model illustrates the potential benefit of HPV vaccination by combining both the effect of vaccine efficacy and the background incidence of HPV-related disease. Our model predictions suggest that prophylactic use of the vaccine against HPV types 6, 11, 16 and 18 has the potential to significantly reduce the incidence of genital warts, cervical intraepithelial neoplasia and cervical cancer. However, the benefits (particularly in terms of cervical cancer reduction) are highly dependent on the duration of vaccine protection, on which evidence is currently limited.

Recommendations regarding HPV vaccination should take into account the uncertainty regarding long-term vaccine efficacy. If mass HPV vaccination is implemented, cervical cancer screening must continue among vaccinated women, and careful long-term post-vaccination surveillance of vaccine efficacy will be essential.

“Marc Brisson was an employee of Merck Frosst Canada Ltd. during the analysis and writing of the first draft of the paper. He has consulted for Merck Frosst and has received reimbursement for travel expenses from GlaxoSmithKline.

“Philippe DeWals has received research grants, reimbursement for travel expenses and honoraria for conferences from vaccine manufacturers, including Aventis Pasteur, GlaxoSmithKline, Shire, Chiron, Baxter, Merck Frosst, and Wyeth-Ayerst.

“Marie-Claude Boily has received an unrestricted grant from Merck Frosst Canada Ltd. for research on the impact of human papillomavirus vaccination.”

___________________________________________________________________________

Paraphrasing Joseph, DO:

“Cervical cancer usually starts to develop in the late 20s to mid 30s. The peak incidence is 45 years of age. The protection period of Gardasil is estimated to be 5 years. That means, if you receive your first set of shots when you’re 10 years old, you’d need at least 2 to 4 additional booster shots to make it through your 30s. And THAT means you’ll have to expose yourself to the potential side effects of Gardasil over and over and over again, with aluminum accumulating in your body and brain with each injection.

“But now to the real clincher, and I want you to read the following section as many times as you need to let this truly sink in…

“U.S. statistics show there are 30 to 40 cervical cancer cases per year per one million women between the ages of 9 and 26, which is the age bracket that Gardasil was tested on.

According to Merck, Gardasil was shown to reduce pre-cancers (it has never been shown to reduce cancers themselves) by 12.2% to 16.5% in the general population. So, instead of ending up with 30 to 40 cases of cancer per million, per year in that age bracket, Gardasil can potentially bring it down to 26 to 35 cases of cervical cancer per million women.

What that means is that you would have to vaccinate one million girls to prevent cervical cancer in 4 to 5 girls.

Further, about 37 percent of women who develop cervical cancer actually die from the disease, so vaccinating ONE MILLION girls would prevent 1 to 2 DEATHS per year, at the bargain-basement price of $360 million per year, plus potentially lifelong suffering for an untold number of women just from the toxic effects of the inoculationi, which has no price tag.

Read more from Dr. Gary Kohls


Dr. Kohls is a retired physician who practiced holistic, non-drug, mental health care for the last decade of his forty year family practice career. He is a contributor to and an endorser of the efforts of the Citizens Commission on Human Rights (www.cchrint.org) and, while still actively practicing medicine, was a member of Mind Freedom International (http://www.mindfreedom.org/),the International Society for Ethical Psychology and Psychiatry (http://psychintegrity.com) and the International Society for Traumatic Stress Studies (https://www.istss.org).

In the first decade of the 21st century, while still practicing medicine, Dr Kohls taught a graduate level psychology course at the University of Minnesota at Duluth. It was titled “The Science and Psychology of the Body-Mind Connection”.

While running his independent clinic, Dr Kohls published over 400 issues of his Preventive Psychiatry E-Newsletter, which was emailed to a variety of subscribers, patients and patient advocates. (The PPENs have not been archived at any website as of this writing.)

Since his retirement, Dr Kohls has been writing a weekly column (titled “Duty to Warn”) for the Duluth Reader, an alternative newsweekly published in Duluth, Minnesota. He offers teaching seminars to the public and to healthcare professionals.

Many of Dr Kohls’ columns are archived HERE HERE and HERE.

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