Human Papillomavirus (HPV) is the most common sexually transmitted infection. Gardasil is a series of three injections designed to prevent HPV in children as young as 9 years old. Its original formulation protected against four HPV strains that can cause cervical cancer and genital warts. Merck manufactures Gardasil and markets it for cervical cancer prevention. Gardasil is the most expensive vaccine on the market.
The FDA approved Merck’s first Gardasil formulation in June 2006 after a 6-month fast-track approval process. Soon thereafter it was recommended by the CDC. (Most vaccines take at least 3 years to get approval and CDC endorsement.) Eighteen months later, the Vaccine Adverse Event Reporting System (VAERS) had received more than 12,000 adverse event reports; 772 were classified “serious.”
In late 2014, the FDA approved the vaccine’s current formulation, Gardasil 9, which protects against five additional virus strains. In 2019, Gardasil made Merck $3.7 billion.
Gardasil’s Dangerous Ingredients
Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) is an adjuvant ingredient in Gardasil that increases the immune response to the vaccine. AAHS is known to cause serious side effects: kick-starting autoimmune disorders, blocking neuron signals, and altering DNA, to name a few. In essence, you need a robust immune response for the vaccine to work, but AAHS overdoes the job.
Under federal law, vaccine adjuvants must be proven safe before use. AAHS was not approved before Merck put it in Gardasil. Merck has repeatedly concealed Gardasil’s (and the placebo’s) true ingredients. For example, Gardasil contains potentially dangerous HPV LI-DNA fragments (another adjuvant), which Merck initially denied but eventually admitted.
Many Gardasil recipients have developed serious illnesses after receiving the vaccine. The Vaccine Injury Compensation Program (VICP) has paid millions in damages for HPV vaccine injuries. Girls have experienced debilitating injuries, including:
As of December 2019, VAERS had received more adverse reports on Gardasil than any other vaccine—64,000-plus. We know vaccine injuries are notoriously underreported. What we don’t know is how many unreported Gardasil injuries exist. The true consequences of HPV vaccination might be even more devastating than we think.
Within 3 months of adding Gardasil to its immunization schedule, the Japanese government withdrew its recommendation, citing the vaccine’s close association with persistent pain. An outraged Indian Parliament accused the Programme for Appropriate Technology in Health (PATH), which administered the vaccines in association with Merck, of violating the human rights of Indian children through Gardasil’s clinical trials.
Plaintiffs have filed lawsuits against HPV vaccine manufacturers and government health agencies in six countries: the U.S., Japan, India, Colombia, Spain, and France. American Gardasil plaintiffs have sued Merck for negligence, strict liability, breach of warranty, and fraud in courts from Orange County to Connecticut.
Children and their parents accuse Merck of:
Conflicts of Interest in the Approval Process
In a lawsuit filed March 30, 2021, an injured plaintiff claims Merck fraudulently manipulated conflicts of interest within the FDA and the CDC’s Advisory Committee on Immunization Practices (ACIP) to obtain Gardasil approval.
Through the National Institute of Health (NIH) Office of Technology Transfer, private industry can license government research. Royalty sharing is part of the deal. Merck purchased licenses to NIH vaccine technology, making Gardasil manufacture possible, and earning the Department of Health and Human Services (HHS), NIH, and the scientists who developed the technology millions of dollars. This practice, in conjunction with the billions pharmaceutical companies spend on FDA approval applications, creates conflicts of interest within the industry.
In a classic case of the revolving door phenomenon, Merck subsequently hired the CDC Director who approved Gardasil as President of Merck Vaccines. And the majority of ACIP committee members that approved Gardasil also had alleged conflicts of interest.
Deceptive Clinical Trials
Scientists, reporters, and plaintiffs have raised alarm bells about the Gardasil clinical trials and the accuracy of their results. They claim Merck used a false placebo, failed to capture adverse event reports, submitted incomplete results for FDA approval, and didn’t get informed consent.
Although Merck claimed to use a saline placebo in its clinical trials, it came to light the placebo contained AAHS. Because AAHS is potentially toxic and was used in both the trial’s vaccine and placebo, any adverse events related to AAHS skewed distinctions between the vaccine and placebo groups. Because the same injuries from AAHS could have been reported in both the control group and the Gardasil group, we can’t know whether adverse events were attributable to Gardasil or AAHS.
Reporting bias caused additional problems with the trial results. Only 10% of clinical trial participants received a “vaccination report card” to report side effects in the two weeks following injection, and all of these were in the U.S. This limited documentation allowed Merck to deny allegations that Gardasil was causing serious systemic injuries. The 14-day reporting period was also inadequate because it ignored longer-onset or chronic conditions.
Also, the protocols vested trial investigators with discretion over whether side effects were vaccine related and should be reported. Multiple clinical trial participants reported side effects and had their concerns dismissed as “not the kind of side effect” expected from the vaccine. If the side effects were noted at all, they were typically reported as “New Medical History”—a means of dissociating the adverse event from the vaccine. But if the purpose of the clinical trial is to test safety, dismissing scores of adverse event reports in the process certainly undermines the results’ accuracy.
Perhaps even more startling, regulators reviewed an incomplete data set when they approved Gardasil. Merck concealed negative results and only reported findings supporting vaccine approval. Plaintiffs allege the FDA only reviewed half the trial data. (And evidence suggests half of trial participants reported adverse events. One could speculate on what that Venn diagram looked like.) In an article published in the British Medical Journal, the authors argue the Gardasil studies contain incomplete reporting and inaccurate details about the placebo. In their opinion, the formulation administered to the control group could not be accurately described as a placebo because it contained AAHS, an “important error that requires correction.” Further, the authors raised ethical concerns about Merck’s trial conduct, suggesting the only way to truly review the trial results at this point would be to review the raw data.
Allegedly, Merck’s informed consent disclosures were also inadequate. If Gardasil is going to be administered to kids, informed consent should be thorough. It wasn’t. Merck allegedly lied to vaccine trial volunteers about the safety of both vaccine and placebo, claiming the clinical trial was not a safety trial. Further, trial volunteers were told the placebo was an inert saline formula, not AAHS.
FOIA requests by journalist Frederick Joelving in 2016-17 revealed that trial protocols listed AAHS as a placebo ingredient, but did not list the other potentially toxic ingredients, including polysorbate 80, borax, genetically modified yeast, L-histidine, and possibly HPV LI-DNA fragments. Investigators knew, or should have known, AAHS was in the placebos but allegedly didn’t tell trial participants. And if investigators didn’t know the additional ingredients, they could not have informed trial subjects. As a result, volunteers could not have received all relevant information about the injections they would receive and could not have given informed consent.
Problems With Protocol 018
Of Gardasil’s 50 clinical trials (called “Protocols”), regulators thought Protocol 018 would provide the most reliable data because its placebo didn’t contain AAHS. What they didn’t know was the placebo contained polysorbate 80, borax, genetically modified yeast, L-histidine, and possibly HPV LI-DNA fragments. Protocol 018’s placebo group did not receive AAHS and, despite the questionable chemical cocktail Merck gave them, fared much better than the other control groups.
Anticipating the lower incidence of adverse reports in the Protocol 018 control group (because the placebo didn’t contain AAHS), Plaintiffs allege Merck gave the Gardasil recipients in Protocol 018 half the AAHS of other protocols. This adjustment in the AAHS dosage resulted in false safety reporting from Protocol 018. Indeed, only 29% of Protocol 018’s vaccinated subjects reported adverse events as opposed to nearly 50% of vaccine recipients receiving the full dose of AAHS in other protocols.
Merck Creates a Market for Gardasil
Merck fear mongered physicians and the public about the prevalence of cervical cancer leading up to its Gardasil release. Merck financed a “proliferation” of cervical cancer awareness conferences and the “End Cervical Cancer in Our Lifetime” campaign. Principal investigator in the clinical trials, Dr. Diane Harper, later accused Merck of creating a sense of panic and urgency to get children vaccinated. “Because Merck was so aggressive, it went too fast,” she said about the vaccine’s push onto the market.
Gardasil protects against colonization of 9 HPV strains. But Merck’s Gardasil clinical trials did not examine the vaccine’s potential to prevent cancer. Merck markets Gardasil as a cancer prophylactic, but we still don’t know for sure that Gardasil prevents cervical cancer. Because it would take too long and require too many participants to conduct a proper trial testing Gardasil’s efficacy at preventing cervical cancer, Merck—with HHS approval—used “surrogate endpoints” instead.
Merck reasoned that because certain cervical lesions caused by HPV can develop into cancer over time, preventing these lesions would prevent cervical cancer. There are several problems with this syllogism, including the fact that HPV is not the only precursor to cervical cancer. Additionally, the surrogate endpoints Merck used in the trial—cervical intraepithelial neoplasia grades 2 and 3 and adenocarcinoma in situ—are common and rarely progress to cancer.
Merck ignored its lawyers’ advice not to claim Gardasil prevents cancer because it’s not proven. Instead, they engaged in an overtly misleading and ubiquitous marketing campaign claiming each vaccinated girl would become “one less” woman with cervical cancer. These advertisements portrayed children with cancer asking their parents, “Did you know?” Policy director for the Canadian Women’s Health Network, Dr. Abby Lippman, was quoted in 2008 saying, “This big push is making people crazy thinking they’re bad moms if they don’t get their kids vaccinated.”
Merck Lobbies Legislators for HPV Vaccine Mandate
Merck lobbied state legislators for HPV vaccine school entry mandates, both directly and through consultants. Merck paid key opinion leaders (respected doctors) $4500 in exchange for lectures on Gardasil’s benefits. Descriptions of Merck’s lobbying efforts ranged from “it was gentle” to it was “a feeding frenzy.”
A national nonprofit called Women in Government (WIG) was heavily involved in the state mandate push. Merck provided WIG “educational grants” in exchange for WIG’s heavy-handed push for mandate bills across the country.
Merck also lobbied the CDC and Congress seeking more federal vaccine financing.
Merck’s lobbying efforts paid off. Twenty-four state legislatures soon proposed Gardasil school-entry mandates, and the U.S. government provided Gardasil to low-income communities at an estimated $1 billion price tag.
Controversy erupted in the 2012 Republican presidential primary when Texas Governor Rick Perry’s opponent, Representative Michele Bachmann, alleged Perry’s financial ties to Merck influenced his 2007 executive order mandating HPV vaccination. Come to find out, Merck had donated thousands of dollars to Perry’s gubernatorial campaigns and Republican Governors Association, for which Perry served as chairman. And Mike Toomey, Perry’s former chief of staff, was employed as a Merck lobbyist when Perry signed the HPV vaccine mandate for Texas teenagers.
The Texas vaccine mandate prompted an opposing House bill. Legislators viewed the mandate as a coercive measure by the state that preempted parental authority. Inspired at least in part by the Perry scandal, Merck later quit lobbying for state mandates.
Efficacy Concerns
When the FDA approved Gardasil, there was no proof it prevented cervical cancer. A 2020 study in the New England Journal of Medicine found a “substantially reduced risk of invasive cervical cancer.”
However, cervical cancer rates are increasing in young women in countries where Gardasil is widely available. Given the fact that without Gardasil as a variable, the average age for cervical cancer diagnosis is a woman’s 50s, these increasing cancer rates among women in their 20s and 30s raises questions about whether Gardasil vaccination (or a lack of associated preventive screening) is actually causing increased cancer rates.
Risk Benefit Analysis
The risks associated with Gardasil must be considered in light of the extremely low threat of fatal cervical cancer.
For girls in the U.S., Gardasil actually increases their risk of death. Per the Gardasil package insert, death occurred in clinical trials in 13.3/10,000 cases. The death rate from cervical cancer in the U.S. is .23/10,000. The highest cervical cancer rates in the world occur in East Africa at a rate of 2.76/10,000.
Many factors influence the development of cervical cancer. Persistent, untreated HPV infections can cause cervical cancer (an estimated .15-.18% of HPV infections worldwide). But in the U.S., cervical cancer is well-controlled with preventive Pap smears. According to the American Cancer Society, cervical cancer is not even in the top 10 deadliest forms of cancer.
HPV is so common the majority of sexually active people will contract it sometime in their life. In most instances, HPV does not cause health problems and resolves without treatment in 90% of cases.
Given that Merck didn’t test Gardasil for its efficacy at preventing cancer, and Gardasil poses substantial health risks to teenagers with almost no immediate risk of dying from cervical cancer, it’s difficult to see how regulators justify its continued use.
Merck’s claims that no data exists to support the link between Gardasil and serious illness are insulting, given that Merck made a concerted effort to conceal negative results in its clinical trials. Weighing the low-risk efficacy of Pap smears against the heartbreaking, sometimes deadly, side effects of Gardasil is a no brainer.
by Leah Rush Easterby
Contributing Editor
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