It has been well over a decade since Merck’s human papilloma virus (HPV) vaccine Gardasil was approved for use. During that time, layer upon layer of research fraud, statistical manipulation, and the purposeful omission of inconvenient facts has created one of medicine’s biggest scandals.
In 2017, historically pro-Big Pharma and pro-vaccine outlet Slate.com launched an eight-month investigation, presumable to debunk the ‘anti-vaccine’ debate once and for all, into the science behind Merck’s HPV vaccine Gardasil. What Slate found wasn’t an open and shut case. Since its inception, the research leading to Gardasil’s regulatory approval has been hotly contested. And now the findings from Slate’s investigation have joined in public lockstep, with the same concerns ‘anti-vaxxers’ have voiced for years, to criticize the lack of science underpinning the HPV vaccine.
Slate’s article reports:
“An eight-month investigation by Slate found the major Gardasil trials were flawed from the outset, however, and that regulators allowed unreliable methods to be used to test the vaccine’s safety.”
It is important to note here that, as Slate rightly explained in their article, drug regulators look much more seriously at potential side effects that surface during pre-licensure studies rather than after a product has been put on the market. So how were Merck’s pre-licensure Gardasil trials flawed?
Slate obtained more than 2,300 pages of documents through Freedom-of-Information requests from hospitals and health authorities. The documents and information led Slate to suggest there were “…inadequacies built into Merck’s major clinical tests of Gardasil.” Slate’s investigation stated:
“To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its years-long trials. At all other times, individual trial investigators used their personal judgment to decide whether or not to report any medical problem as an adverse event—essentially, as a potential side effect worth evaluating further.”
Rather than tracking all side effects (adverse reactions) the same, investigators were free to cherry-pick reactions they felt were important essentially handicapping the integrity and quality of the Gardasil trials.
After the disingenuous Gardasil trials that led to its regulatory licensing, the global public at large became the final phase of testing. In the real world, where adverse reactions and inconvenient findings can’t be discarded by Merck researchers, the US Vaccine Adverse Events Reporting System (VAERS) is the only effort in place to chronicle issues with the HPV vaccine. VAERS has logged 54,105 adverse reactions related to the HPV vaccine. Among those, 2,227 are listed as “disabled,” 10,416 are listed as “did not recover,” 7,418 are listed as “serious,” and 362 deaths have been reported. Many other reports were listed on VAERS including emergency room visits after vaccination [14,928], hospitalized [5,155], and life-threatening [868].
A US Health and Human Services-funded study by Harvard Medical School tracked reporting to VAERS over a three-year period at Harvard Pilgrim Health Care involving 715,000 patients and found that “fewer than 1% of vaccine adverse events are reported.” A US House Report similarly stated: “Former FDA Commissioner David A. Kessler has estimated that VAERS reports currently represent only a fraction of the serious adverse events.” Recalculating the VAERS HPV reports using Harvard Medical School’s findings of only one percent reporting, the current VAERS information from the HPV vaccine reporting could in reality be as high as 5,410,500 adverse reactions, 1,041,600 disabled, and 36,200 deaths.
VigiAccess is an interface that houses data on medicines and vaccine side effects (adverse reactions) reported to the WHO Programme for International Drug Monitoring (WHO PIDM). The system shows 192,039 reported adverse reactions globally for the three HPV vaccines combined.
Since regulators look much more seriously at potential side effects that surface during pre-licensure studies, official efforts to investigate the scale of injuries from the HPV vaccine has been little to none. We have witnessed a global generation left debilitated by health problems from the HPV vaccine that regulators, global health authorities, and the establishment medical community at large have flatly ignored.
Investigations from around the world in Ireland, Colombia, Japan, Denmark, American, Africa and others have shown near exact patterns of severe adverse reactions from the HPV vaccine programs once they are initiated, and in some cases forced, by government health agencies. Japan’s health agency officially retracted its HPV recommendation only months after mounting injury caused massive pushback from the public.
700 girls in Colombia are currently in the middle of a major class action lawsuit against Merck Sharp & Dohme for damages caused by the Gardasil vaccine.
Ireland’s Health Service Executive (HSE) completely turned their back on its country's HPV-injured girls by refusing to investigate or acknowledge the mounting injuries from its deeply flawed HPV vaccine campaign.
In 2014 Gardasil 9 was approved for marketing and use on the public. However, it appears that Merck’s old habits of statistical manipulation and unscientific operations were again at work behind the scenes during Gardasil 9’s pre-licensure testing. According to Slate’s recent article,
“European health regulators worried about Merck’s methods during a review of the company’s marketing application for Gardasil 9, the latest version of the vaccine, but have not made their concerns public. In an internal 2014 EMA report about Gardasil 9 obtained through a freedom-of-information request, senior experts called the company’s approach “unconventional and suboptimal” and said it left some “uncertainty” about the safety results. EMA trial inspectors made similar observations in another report, noting that Merck’s procedure was “not an optimal method of collecting safety data, especially not systemic side effects that could appear long after the vaccinations were given.” Slate’s findings regarding the EMA’s backchannel honesty about Gardasil 9’s safety issues are a slap in the face to their public talking points calling the vaccine ‘safe and effective.’ Untold numbers of parents are, and have been, demanding answers, further investigation, and help for their HPV vaccine injured daughters only to be stonewalled by the EMA, WHO, and other international health bodies.
Similar findings concerning Gardasil 9’s poorly handled safety testing have been brought to the attention of Marion F. Gruber, PhD Director of the Office of Vaccines Research and Review Consumer Affairs Branch at the US Food and Drug Administration by the non-profit organization Informed Consent Action Network (ICAN). ICAN’s letter to Gruber states:
“We write regarding an apparent error in the package insert for Gardasil-9 indicates that the rate of systemic autoimmune disorders during the clinical trials for Gardasil was similar in (i) the saline placebo control group, (ii) the AAHS (aluminum adjuvant) control group, and (iii) the Gardasil group. Since the saline placebo group had no cases of systemic autoimmune disorders while the Gardasil group and AAHS control group had hundreds of such cases, a claim that they had similar systemic autoimmune disorder rates is inaccurate.”
Can the public trust drug companies to study their own products with integrity? According to the facts uncovered by Slate and others, the answer appears to be no. Can we trust post-marketing surveillance and regulatory agencies to adjust their official stances when vaccines injure growing populations of people? So far, the answer to that question is also no with the exception of Japan.
In 2017, historically pro-Big Pharma and pro-vaccine outlet Slate.com launched an eight-month investigation, presumable to debunk the ‘anti-vaccine’ debate once and for all, into the science behind Merck’s HPV vaccine Gardasil. What Slate found wasn’t an open and shut case. Since its inception, the research leading to Gardasil’s regulatory approval has been hotly contested. And now the findings from Slate’s investigation have joined in public lockstep, with the same concerns ‘anti-vaxxers’ have voiced for years, to criticize the lack of science underpinning the HPV vaccine.
Slate’s article reports:
“An eight-month investigation by Slate found the major Gardasil trials were flawed from the outset, however, and that regulators allowed unreliable methods to be used to test the vaccine’s safety.”
It is important to note here that, as Slate rightly explained in their article, drug regulators look much more seriously at potential side effects that surface during pre-licensure studies rather than after a product has been put on the market. So how were Merck’s pre-licensure Gardasil trials flawed?
Slate obtained more than 2,300 pages of documents through Freedom-of-Information requests from hospitals and health authorities. The documents and information led Slate to suggest there were “…inadequacies built into Merck’s major clinical tests of Gardasil.” Slate’s investigation stated:
“To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its years-long trials. At all other times, individual trial investigators used their personal judgment to decide whether or not to report any medical problem as an adverse event—essentially, as a potential side effect worth evaluating further.”
Rather than tracking all side effects (adverse reactions) the same, investigators were free to cherry-pick reactions they felt were important essentially handicapping the integrity and quality of the Gardasil trials.
After the disingenuous Gardasil trials that led to its regulatory licensing, the global public at large became the final phase of testing. In the real world, where adverse reactions and inconvenient findings can’t be discarded by Merck researchers, the US Vaccine Adverse Events Reporting System (VAERS) is the only effort in place to chronicle issues with the HPV vaccine. VAERS has logged 54,105 adverse reactions related to the HPV vaccine. Among those, 2,227 are listed as “disabled,” 10,416 are listed as “did not recover,” 7,418 are listed as “serious,” and 362 deaths have been reported. Many other reports were listed on VAERS including emergency room visits after vaccination [14,928], hospitalized [5,155], and life-threatening [868].
A US Health and Human Services-funded study by Harvard Medical School tracked reporting to VAERS over a three-year period at Harvard Pilgrim Health Care involving 715,000 patients and found that “fewer than 1% of vaccine adverse events are reported.” A US House Report similarly stated: “Former FDA Commissioner David A. Kessler has estimated that VAERS reports currently represent only a fraction of the serious adverse events.” Recalculating the VAERS HPV reports using Harvard Medical School’s findings of only one percent reporting, the current VAERS information from the HPV vaccine reporting could in reality be as high as 5,410,500 adverse reactions, 1,041,600 disabled, and 36,200 deaths.
VigiAccess is an interface that houses data on medicines and vaccine side effects (adverse reactions) reported to the WHO Programme for International Drug Monitoring (WHO PIDM). The system shows 192,039 reported adverse reactions globally for the three HPV vaccines combined.
Since regulators look much more seriously at potential side effects that surface during pre-licensure studies, official efforts to investigate the scale of injuries from the HPV vaccine has been little to none. We have witnessed a global generation left debilitated by health problems from the HPV vaccine that regulators, global health authorities, and the establishment medical community at large have flatly ignored.
Investigations from around the world in Ireland, Colombia, Japan, Denmark, American, Africa and others have shown near exact patterns of severe adverse reactions from the HPV vaccine programs once they are initiated, and in some cases forced, by government health agencies. Japan’s health agency officially retracted its HPV recommendation only months after mounting injury caused massive pushback from the public.
700 girls in Colombia are currently in the middle of a major class action lawsuit against Merck Sharp & Dohme for damages caused by the Gardasil vaccine.
Ireland’s Health Service Executive (HSE) completely turned their back on its country's HPV-injured girls by refusing to investigate or acknowledge the mounting injuries from its deeply flawed HPV vaccine campaign.
In 2014 Gardasil 9 was approved for marketing and use on the public. However, it appears that Merck’s old habits of statistical manipulation and unscientific operations were again at work behind the scenes during Gardasil 9’s pre-licensure testing. According to Slate’s recent article,
“European health regulators worried about Merck’s methods during a review of the company’s marketing application for Gardasil 9, the latest version of the vaccine, but have not made their concerns public. In an internal 2014 EMA report about Gardasil 9 obtained through a freedom-of-information request, senior experts called the company’s approach “unconventional and suboptimal” and said it left some “uncertainty” about the safety results. EMA trial inspectors made similar observations in another report, noting that Merck’s procedure was “not an optimal method of collecting safety data, especially not systemic side effects that could appear long after the vaccinations were given.” Slate’s findings regarding the EMA’s backchannel honesty about Gardasil 9’s safety issues are a slap in the face to their public talking points calling the vaccine ‘safe and effective.’ Untold numbers of parents are, and have been, demanding answers, further investigation, and help for their HPV vaccine injured daughters only to be stonewalled by the EMA, WHO, and other international health bodies.
Similar findings concerning Gardasil 9’s poorly handled safety testing have been brought to the attention of Marion F. Gruber, PhD Director of the Office of Vaccines Research and Review Consumer Affairs Branch at the US Food and Drug Administration by the non-profit organization Informed Consent Action Network (ICAN). ICAN’s letter to Gruber states:
“We write regarding an apparent error in the package insert for Gardasil-9 indicates that the rate of systemic autoimmune disorders during the clinical trials for Gardasil was similar in (i) the saline placebo control group, (ii) the AAHS (aluminum adjuvant) control group, and (iii) the Gardasil group. Since the saline placebo group had no cases of systemic autoimmune disorders while the Gardasil group and AAHS control group had hundreds of such cases, a claim that they had similar systemic autoimmune disorder rates is inaccurate.”
Can the public trust drug companies to study their own products with integrity? According to the facts uncovered by Slate and others, the answer appears to be no. Can we trust post-marketing surveillance and regulatory agencies to adjust their official stances when vaccines injure growing populations of people? So far, the answer to that question is also no with the exception of Japan.
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