The HPV vaccine continues to be one of the most controversial vaccines in history. Numerously reported side-effects stemming from the Gardasil shot have caused parents worldwide to clamor at the thought of giving it to their teenage children. New Jersey, in fact, is attempting to make the HPV vaccine mandatory, which tells you just about everything you need to know about how parents likely feel over the matter.
In 2018 already, there have been 85,329 reports of adverse reactions to the HPV vaccine, as reported by the VigiAccess database.
Now, Merck is being accused of “fast-tracking” the Gardasil vaccine, according to GreenMedInfo.
Back in 2016, a California family filed a complaint with the Superior Court of the State of California against Gardasil maker, Merck. They claim that their daughter received the Gardasil shot three times over the course of a year starting in 2010. The girl, over the next few years, would be diagnosed with POTS and later on, a small fiber neuropathy that affected her entire body.
Her family became convinced that their daughter’s health issues stemmed from the Gardasil shots she took in the years prior. The family has accused Merck of deceitful marketing practices and rushing the drug to market.
“Upon approval by the FDA of the Gardasil vaccine, Defendants Merck, Does 1 through 25, and each of them commenced and engaged in highly extensive, and aggressive marketing practices, which were designed primarily, if not solely, to increase the sales and profits from Gardasil. In doing so, Defendants Merck, Does 1 through 25, and each of them, in order to preclude any and all questions by consumers, patients and others, as to the effectiveness, safety and need for the administration of the Gardasil vaccination as well as the risks of serious adverse reaction related thereto, intentionally, wrongfully and deceitfully withheld, failed to provide and concealed from consumers, patients and others material facts and information with respect to the effectiveness, safety and need for the administration of the Gardasil vaccination, as well as the risks of serious adverse reaction related thereto and as in part hereafter set forth.” (own emphasis)
“Further, Defendants Merck and Does 1through 25 in its Marketing wrongfully and deceitfully failed to unambiguously inform those to whom the marketing was directed, of material facts and information which they knew or should have ascertained through their investigations and studies specific to risk/ benefit and quantitative risk assessments regarding and including, among other things, the following:
1. The five-year period that the Gardasil vaccine was then only known to be effective;
2. That Gardasil was effective only as to certain and not other strains of the HPV virus;
3. The Gardasil vaccine is not effective once an individual is infected with the HPV virus;
4. Other existing methods that are effective in avoiding HPV viral infections;
5. The minimal risk that even once the individual was infected with the HPV virus the infection would result in precancerous lesions;
6. The successfulness of exiting methods of diagnosing and treating HPV precancerous lesions;
7. The successfulness of exiting methods of diagnosing and treating any resulting cancer;
8. The nature as the consequences of serious adverse reactions to the HPV vaccine; and
9. Other items related and material to risk/benefit and quantitative risk assessments not now known and if required leave of Court will be requested to amend this complaint to set forth fully such item or items when ascertained
Such information was and is reasonably required by patients and consumers as well as others when considering and deciding whether or not under their individual and personal circumstances to be vaccinated with Gardasil.”
The judge agreed to a full day of discussions involving scientific experts to speak to the Gardasil vaccines chemistry. The plaintiff provided a number of expert analysis before the judge, much of which contrasts today’s HPV marketing pitch that asserts HPV causes cancer.
“There are approximately 130 strains of the HPV virus, of which only 15 to 18 strains are known to be associated with cervical cancer. The Gardasil vaccine provides protection against only 4 specific strains, namely HPV 6, 11, 16 and 18. Strains 16 and 18 are thought to be casually associated with 70 % of the worldwide HPV related cervical cancers. HPV 6 & 11 are associated with warts.
As stated, ninety-five (95%) percent of HPV infections are removed from the body by its own immune and related processes without medical or other consequences. Any abnormal cell growth associated with the remaining 5%, approximately 20% (1% of the total), if not identified and removed could be at risk of developing into cancerous cells in approximately 5 years which could progress to irreversible cancer in 15 to 30 years. The incidence of cervical cancer occurring in the United States is estimated to be 1.4 to 2.3 per 100,000. The risk of precancerous cells, due to the presence of the HPV 16 and 18 viruses, progressing to cervical cancer is estimated at 1.5 per 100,000. The actual incidence rate of serious adverse events after HPV vaccination is unknown.”
“Initially, qGardasil is not a treatment process and does not prevent cancer as marketed by Merck. Gardasil is a vaccine designed to increase the response of the Human Immune system to pathogens namely HPV viruses 6, 11, 16 & 18.”
“The foregoing is merely illustrative of the complex and extensive scientific factors involved in this litigation. Although the purpose of Science Day it to provide the Court with information as to the nature and extent of the complex scientific matters involved, it is necessary to connect these matters to a foundation rooted in the facts of the case before the Court, which may be construed as argument.
Scientific issues not addressed in this Brief, which are relevant to the safety, efficacy/effectiveness, need and risk/benefits of qGardasil include, without limitations, the following:
1. Fast tracking of the FDA approval process to a 6-month period when criteria for fast tracking were not met.
2. Five-year effectiveness of qGardasil as of 1/1/2011, now believed to be 8 years.
3. Use of end points which did not establish the effectiveness of qGardasil.
4. Effect on the clinical trial analysis of the removal of participants experiencing adverse and serious adverse events.
5. The effect of non – HPV 16 and 18 cancer producing strains on cervical cancer occurrence when HPV 16 and 18 are eliminated.
6. Lack of adequate pediatric clinical testing of the qGardasil regarding potential ovarian disorders/failures.
7. The effect of clinical testing and studies involving undeveloped countries on U.S. analysis.”
Merck’s response came up short in any way to counter the plaintiff’s scientific submissions.
“At Science Day, Merck intends to provide the Court with: (1) an overview of The National Childhood Vaccine Injury Act of 1986 and the National Vaccine Injury Compensation Program, and their impact on the present litigation; (2) background information about the development and approval of vaccines and, specifically, Gardasil, in the United States; and (3) a detailed review of the extensive safety data that established and has continually reaffirmed the safety profile of Gardasil.”
“Although plaintiff alleges a moving target of injuries and purportedly related symptoms, Merck’s Science Day presentations will address the three on which plaintiff currently seems most focused; autoimmune diseases, demyelinating diseases, and Postural Orthostatic Tachycardia Syndrome (“POTS”). A preview of the data concerning Gardasil and these conditions is set forth herein.”
But Merck’s main play in the matter was absolutely stunning. Rather than scientifically dispute the matter, the giant pharmaceutical company decided to slander and discredit an antivaccination site, SaneVax, to attempt to detach themselves from the submitted evidence showing Gardasil’s ill-effect potential and the lack of percentage chances that HPV causes cervical cancer.
This is hardly a scientific approach and only serves to discredit Merck.
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