Shining a light on HPV II

Predatory shot peddlers

This is Part 2 of a two-part series. In Part 1, we learned what HPV is and how big a threat. We looked at the creation of the vaccine and its effect on cervical cancer rates.

In this half of the story, we’ll discuss how a market was created “out of thin air” for the HPV vaccine and how fervently and manipulatively the shot is pushed on our children. We’ll also dive into the safety risks and the government’s actions supporting the shot.

Highlights

• Gardasil was the first vaccine to be fast-tracked by the FDA, meaning the testing process was faster and less thorough than for other vaccines.
• Informed consent did not exist for the young women in the Gardasil trial because there was no true placebo.
• Merck markets Gardasil to vulnerable teenagers and their parents, playing on the fear of developing cancer if they don’t get the vaccine.
• Such shady marketing techniques underscore how important it is for parents and legislatures to stay vigilant about the coming wave of School-based Health Centers, where children are often treated without parental involvement.
• One researcher involved in the clinical trials tried to raise alarm bells about the product’s safety and but had trouble getting her message out.
• Merck makes billions selling Gardasil. The federal government is receiving a cut of that profit.
• The HPV vaccine has caused a very high number of adverse reactions reported to VAERS.
• Dr. Sin Hang Lee discovered that the vaccines are contaminated with DNA fragments. After extensive research, he believes Merck and public health organizations are guilty of manipulating data and suppressing science to maintain an illusion that the HPV vaccine is safe.
• As of September 2024, a massive litigation effort is underway to hold Merck accountable for its claims that the HPV vaccine is safe and effective.

Big money for Merck

Gardasil, the HPV vaccine touted to prevent cervical cancer, has made billions of dollars almost every year since its launch.¹ In 2003 alone, profits were $8 billion.²

But Gardasil wasn’t just a sales success; the vaccine is rumored to have saved Merck. At the time the first HPV vaccine was developed and launched in the U.S., its maker, Merck, was facing public backlash and multi-billion-dollar lawsuits over scandal surrounding Vioxx, an arthritis painkiller.³ But Merck promoted the drug for other uses and lied to its shareholders, the FDA, and the public about how dangerous the drug was.⁴ It caused tens of thousands of heart attacks and deaths (or more) in Americans over the five-year period it was on the market.⁵ Merck agreed to pay $4.85 billion to settle injury and death claims, another $950 million to the Department of Justice for criminal charges related to lying about its usefulness and safety, and an additional $830 million to investors for the whole mess.⁶

Enter Merck’s second-most-profitable product: Gardasil.

Clinical trials

A lot has been written about the clinical trials for Gardasil. Without going into detail, this article offers an overview to bring awareness of the serious problems with the trials.

Gardasil was the first vaccine to be fast-tracked by the FDA. This means it went through less testing than other vaccines before being put on the market.

Fast-tracking means the FDA will start evaluating clinical trial information as it is produced, on a “rolling basis,” rather than only looking at data only after the clinical trials are done. This is hugely significant because clinical trials are typically the lengthiest part of developing a drug, estimated by the FDA as around 3-7 years.⁷ Fast-tracking saved the company millions in research dollars.

For a drug to qualify for Fast Track designation, the manufacturer must meet certain criteria: The proposed drug must (1) treat a serious condition; (2) meet an unmet medical need; and (3) show an advantage over any available therapy. The book “The HPV Vaccine on Trial” informs us the FDA did not consider the Pap test to be an available therapy because it is a diagnostic tool rather than a preventative therapy.⁸ Therefore, by ignoring the Pap test as a tool to fight cervical cancer, Gardasil could wave the flag of “unmet need.” The FDA considers it “obvious” that any drug proposed to treat or prevent a condition with no current therapy would meet an unmet medical need.⁹

The FDA granted Gardasil Fast Track designation in 2002. In 2005 while clinical trials were ongoing, it granted the drug priority review as well (an additional way to speed the process). This meant the FDA would decide on licensure in six months rather than the typical 10. Many parents, policymakers, and researchers questioned why the FDA was in such a rush to license Gardasil.

Gardasil was licensed in 2006, even though the clinical trial end date was scheduled for 2009.

That first shot contained only two strains of HPV: 16 and 18.¹⁰ The next generation of Gardasil added two more, 6 and 11, and was also granted Fast Track and priority review. Gardasil 9, which added strains 31, 33, 45, 52, and 58, was granted the same. Merck is currently looking at adding more strains.

Trials didn’t test for cervical cancer prevention

Because of a medical assertion that there’s a step-by-step progression from HPV to cancer, Merck and the government decided something less than cervical cancer could be used as an “end point” to evaluate vaccine success. They reasoned: if we can say that the HPV vaccine stops the appearance of abnormal cells on the cervix, then it must also stop cervical cancer. Was this appropriate? As detailed in Part 1 of Shining a light on HPV, there is not a direct cause and effect path from acquiring HPV to a diagnosis of cervical cancer. There are known cases of cervical cancer without HPV infection, and most HPV diagnoses do not end in cancer diagnosis. Regardless, the FDA gave the OK to a substitute endpoint for the trials.

As pointed out in “The HPV Vaccine on Trial,” the fact that Merck did not have to test whether the vaccine did as it claimed-to prevent cervical cancer “allowed Merck … to shorten the clinical trials to a few years,” further accelerating the path to licensure.¹¹ Interestingly, because cervical cancer is so rare, it would have been difficult and costly to run a trial with cancer as the end point. “Researchers also knew that because cervical cancer is rare and has a long latency period, clinical trials using it as the end point would need an impossibly large number of participants followed over a long period of time to measure efficacy.” What does it say about the need for a vaccine, if it’s too difficult and expensive to run a trial because there aren’t enough people with the condition they were claiming to prevent?

Clinical trial participants were deceived

Most troubling about the Gardasil trials is the fact that young women thought they were getting either the vaccine or a harmless saline placebo, but instead nearly everyone received a shot containing aluminum. There was no informed consent.

People assume that vaccines are tested against saline placebos. But that’s not typically the case. In fact, the participants in the clinical trials for Gardasil were given either the experimental vaccine or a shot with all of the ingredients except the virus particles. In other words, everyone got aluminum, which is a known toxin. The reason aluminum is put in vaccines at all is to irritate the body to cause a larger immune response to the virus.

Many of these young trial participants suffered death or years of side effects from both the vaccine and the “placebo” containing aluminum.

Researcher and writer Mark Blaxill, author of “The Age of Autism,” estimates the death rate among clinical trial participants was three times higher than expected, but the FDA did not attribute any of the 10 deaths in Gardasil recipients nor the seven deaths in the “placebo” group to the vaccine.¹²

A very detailed account of the trials, ethical issues, injured and killed children, can be found in “The HPV Vaccine on Trial” by Mary Holland, J.D., Kim Mack Rosenberg, J.D., and Eileen Iorio. A list of the tragic stories of victims of the HPV shot can also be found at Sanevax.org. Follow the Instagram account Gardasil Girls to learn more. We strongly encourage you to read these stories to honor the victims who lost their lives to this shot and their families.

Short on data but long on claims

When the fast-tracked vaccine was licensed by the FDA in 2006, “doctors such as Dr. Emily Senay … stated that the vaccine was ‘highly effective’ and that the clinical trials showed the vaccine to be ‘100 percent effective’.”¹³ This claim was made, even though Merck was not required to show that their vaccine prevented cancer. Cervical cancer takes decades to grow so it’s efficacy couldn’t be known for many years of postmarket data.

Sadly, as we discussed in Part 1, we know that once the dust settled on the novelty of this shot, it’s clear that it’s not 100% effective, wanes over time, can cause the illness it claims to prevent, and is incomplete because there are so many strains of the virus.

“It made a market out of thin air”

It’s safe to say that the HPV shots are the most heavily marketed vaccines ever created. Awards were won for the innovative and effective advertising strategies. Graduate students wrote theses on the techniques and the ethics of it. Books have been published about it.¹⁴ You may think the COVID shot was the first fast-tracked vaccine, but read on to see if you notice how the COVID shot echoes the advertising techniques used to sell the HPV vaccine.

Who was Merck marketing to? And why did they make such a huge effort?

The second question sets the stage: Merck had to make a huge effort because people weren’t concerned about HPV.

In other words, to offer a solution, they had to convince people there was a problem.

“Merck facilitated the social construction of the human papillomavirus as a problem needing treatment and successfully positioned Gardasil to be the solution to that problem.”¹⁵

In Part 1 of the story of the HPV vaccine, we describe how when Merck started development and clinical trials for the shot, there was still doubt in the scientific world about whether HPV causes cervical cancer. Insiders at Merck credit the trials themselves with putting those doubts to rest. How could a drug trial confirm the connection between the presence of human papillomavirus and cancer many years later?

The man who is credited with making the link between HPV and cancer in the 1980’s was turned away by pharmaceutical companies when he pitched a vaccine. But in the early 2000s, while the Vioxx scandal was starting to surface, Merck “made a market out of thin air” by employing a two-part, six-figure advertising campaign.¹⁶ The first phase was the clincher — it was presented as a public service announcement urging women to “‘Make the Connection’ between HPV and cervical cancer.” It was run as a public health awareness campaign by nonprofits and it sold nothing more than a new belief. But planting that new belief in the minds of young girls and their parents was key to creating the market. Merck funded this campaign before the FDA licensed its vaccine. The company hid in the shadows of nonprofit organizations that put their name on the ads.

“What makes Gardasil’s campaign stand out from other direct-to-consumer advertisements is its use of the “Tell Someone” public service announcement campaign to introduce the problem of HPV before the drug was introduced to market.”¹⁷ (emphasis added).

Merck used the nonprofits Step Up Women’s Network and the Cancer Research and Prevention Foundation to covertly create a market for the HPV vaccine. Merck funded the “informational” campaigns called “Making the Connection” and “Tell Someone,” branded under the name of the two nonprofits. The PSAs did not give any solutions, like abstinence or screening, nor did they tell women that HPV is very common and usually goes away on its own. Instead they left viewers hanging, sitting with a new fear, and being told to spread the word and talk to their doctors.

By quietly funding campaigns to link HPV to cancer before doing any obvious marketing, “Merck was able to secure a market for its product prior to it being approved and released.”¹⁸ “[T]he construction of HPV as a social problem fostered the acceptance of Gardasil and of its widespread use.”

Who was Merck marketing to? They targeted teenage girls first and their parents second. A vulnerable market, indeed.

Merck’s president for global human health outlined the goals for their product launch after licensure in 2006: “support global policy recommendations, secure broad public and private funding, encourage strong uptake among healthcare providers, and motivate women in the target age group (or their parents) to ask for the vaccine. Another hurdle was to gain the support of policymakers because in order to gain the broad coverage that it hoped for, Gardasil had to be integrated into the children’s vaccine schedule.”¹⁹

Bev Lybrand was the general manager for Gardasil at Merck and was quoted explaining how they sold fear: “Of course everyone understands cancer and is scared of cancer.”²⁰ Merck also simultaneously played on a mother’s instinct to protect her child, as well as a young woman’s longing for empowerment.

Almost every country in the world bans direct-to-consumer (DTC) advertising for pharmaceutical products. Nowhere other than the United States and New Zealand will you see commercials for vaccines and other drugs on the television. By speaking directly to audiences through the lights and sounds of screens, DTC ads have been massively influential on a population that just keeps getting sicker. As it turns out, side effects of DTC ads include massively increased sales, patient preference for more expensive brand names over generics, patients asking for drugs they don’t need, and an increasingly sick population.²¹

Merck wanted young women to think they would be “one less” woman with cervical cancer, but never told them what the chances were of being “one” at all! Here is an overview of risk from Part 1:

Merck intentionally “influence[d] consumers’ perceptions about the possibility of cervical cancer and the ability to have control over the risk by having the Gardasil vaccines.”²²

Even though HPV is typically associated with genital warts and other growths, Merck had to market their product as a “cervical cancer vaccine” because of the stigma around STDs and the necessity to sell the product to young children. The product doesn’t work if a person has already been infected.²³ In fact, in Part 1 we exposed evidence it causes more cancer if administered after infection.

Researchers have also observed: “Notably, in 2009 GARDASIL® was approved by the FDA for boys and young men between 9-26 years old. Yet there has not been the equivalent amount of pervasive marketing campaigns encouraging young men and boys to get vaccinated with GARDASIL® or convincing their parents that it is a necessary part of their son’s healthcare. … The recommendations for young women and young men, at a minimum, should be the same, especially considering that women have a first line of defense against cervical cancer through a Pap smear examination detecting abnormal cells potentially linked to HPV, while there is no routine prevention exam equivalent for men.”²⁴

Merck’s advertising team was smart. They framed the product to intentionally tug on psychological strings, as any good marketer would. The pitch played on a type of FOMO, “fear of missing out,” and oversimplification of the choice to be made, boiling the message down to a false binary decision: get the shot or get cancer. People are hard wired to want to avoid something they fear, of course, and this is why fearmongering works.

In a cultural context of the rise of “girl power,”²⁵ the ads also incorporated a sense of “shared values” and trust by featuring mothers and doctors.²⁶ The advertisers heightened the sense of risk of cancer, while making young women feel in control and empowered to conquer the thing they fear with this hyped-up product.

One researcher involved in the clinical trials tried to raise alarm bells when the product was coming to market. As reported by Sharyl Atkisson for CBS news, Dr. Diane Harper wanted the world to know the risks could outweigh the benefits and the claimed protection may not last very long.²⁷ She had trouble getting her message out, trying for months to get major news outlets to listen to her. As stated by Blaxill, “Why was an inside critique of the Gardasil promotion campaign not already big news? ‘No one will print it,’ Harper said.”²⁸

The federal government benefits from sales of Gardasil

The year the ACIP recommended the HPV vaccine for males, 2007,²⁹ a report by the HHS Inspector General noted that the “CDC did not identify or resolve potential conflicts of interest for 64% of special government employees,” which includes the ACIP.³⁰

Interestingly, Blaxill was able to get a reaction from someone in the room in 2006 when the ACIP unanimously voted to recommend Gardasil just 23 days after FDA approval who noted an inappropriate celebration:³¹

According to Sanevax.org,³² which was established in 2010 directly in response to the worldwide devastation left in the wake of HPV vaccination introduction:

The “recombinant papillomavirus capsid proteins” remained one of the top four “commercially successful inventions” for our federal government from 2007 through 2020.³³ According Blaxill, who also helped found the Canary Party,³⁴ the Department of Health and Human Services “can transfer technology to pharmaceutical partners, simultaneously both approve and protect their partners’ technology licenses while also taking a cut of the profits.”³⁵ However, we do not know how much the federal government has made from recommending the shot, as more than one FOIA has gone unanswered. We do know that Gardasil has generated billions in sales for Merck. And our federal government, after using our tax dollars to develop a product, is receiving a cut of that profit, the amount of which they refuse to disclose.

You can read Blaxill’s three-part article “A license to kill?” published at the ageofautism.org for a thorough look at the conflicts of interest involved in the relationship between Merck and our federal government with respect to the Gardasil vaccine.³⁶ He states that ”there’s “an unprecedented web of conflict, on in which the same departments that are tasked with regulating the health and safety of medical products are also profiting from them.”

Medical and public health organizations promote the drug

The National Cancer Institute (NCI) funded a study published in 2018 to determine what messaging works best to convince parents their kids need the HPV shot.³⁷ The NCI, a taxpayer-funded institution, thinks “motivating more parents to vaccinate is key.” The NCI is aiming to help achieve the Healthy People goal of 80% HPV vaccination,³⁸ even providing materials for increasing shots through education, recommendations, and talking points (one of which is called “Give teens vaccines.”).³⁹

The American Cancer Society partnered with the CDC to create a “HPV Roundtable” group in 2014, with the goal of “raising HPV vaccination rates and preventing HPV cancers in the United States.”⁴⁰ Rather than tell you who’s a member, it’s easier to simply say it’s hard to find a public health organization that’s not a member.

On the roundtable website, the ACS declares, “HPV vaccination is cancer prevention,” and asserts the vaccine prevents “more than 90% of six HPV cancers,” claiming, “[r]esearch has shown that vaccination provides close to 100% protection against infections, precancers, and cancers caused by the types of HPV included in the vaccine.”⁴¹

The roundtable has a series of educational videos for health providers, and the very first session featured is not about what HPV is, or how HPV may cause cancer, or how the HPV vaccine works. Instead they kick off their education with “Vaccine Hesitancy and Communication.”⁴²

The HPV Roundtable hosts an annual meeting with a “fun and inclusive learning environment,” which has a different theme each year. In 2023, participants were surrounded by an island theme while “national experts, survivors, and thought leaders” collaborated and brainstormed on how to “nearly eliminate cervical cancer in the U.S.”⁴³ In previous years, the conference has taken on sports and space exploration themes. Merck was one of the sponsors. So was the CDC – in other words, our taxpayer dollars – helping pay for this event? Why would a vaccine claiming to prevent a cancer need to be promoted at conferences that look like adults at summer camp?

The HPV shot push in schools

In 2007, there was a rush to get states to mandate HPV shots for school enrollment. But there was huge backlash not just from health freedom advocates, but also from religious people who argued the vaccine would encourage promiscuous sex.⁴⁴ Since the vaccine had been fast-tracked, it was still in its clinical trial stages — in other words, it was still experimental — until September 2009.⁴⁵ Yet suddenly in 2007, states across the country considered bills to mandate this experiment for school entry.

Why would they do that? Even The New York Times noted that it was “unusual” for states across the nation to be in a “rush” to mandate a shot for young children this quickly. “Typically new vaccines … have been rolled out gradually in this country, with public health officials endorsing mandatory use only after several years of experience have shown the new products to be generally safe and effective.”⁴⁶

Many health providers report that parents only want to get the shots necessary for school, so if there isn’t a mandate, parents are less likely to consent.⁴⁷ The lack of a mandate is seen as a “barrier” to HPV shot uptake.

Despite blockbuster sales, the HPV vaccine is the least accepted at adolescent medical visits.⁴⁸ Uptake was steadily increasing through 2020 but the declared COVID pandemic derailed the progress toward the Healthy People 2020 (now 2030) goal of 80% coverage.

The American Physicians and Surgeons (AAPS) painted the picture: “Without adequate testing but with well-placed political funding and lobbyists, Merck pushed for requiring that the HPV vaccine, Gardasil, be given to young schoolgirls as a condition for entering sixth grade. But the disease it supposedly protects against is not even contagious in the school environment.”⁴⁹

Merck teamed up with the nonprofit Women in Government (WIG) to push the mandate agenda in states. According to their website, the group has been around since around 1990 to facilitate discussion about “cutting edge policy issues.” Similar to the strategy with public service announcements that were branded by a nonprofit but funded by Merck, Women in Government was the forward-facing nonprofit that pitched the mandates. “In early 2007, this group organized an all-expense paid conference in Florida and invited nearly sixty state legislators to learn about the vaccine. Subsequently, twenty states and the District of Columbia drafted bills in favor of mandatory vaccination of school-aged girls.”⁵⁰

The group was found to have many ties to lawmakers and governors that were considered unsavory once mandate bills were presented. Most notoriously, the group was found entangled with Texas Governor Rick Perry’s 2007 executive order to mandate that all sixth grade girls get Gardasil.⁵¹ The Texas WIG state director was in the state house of representatives and happened to be the mother-in-law of the governor’s chief of staff. The Merck lobbyist was Perry’s former chief of staff. Merck’s money was not only in WIG coffers, but they also donated to Perry’s campaign. When this information came to light, there was a huge public backlash. The Texas legislature ended up overturning the executive order by a vote of 181 to 3.⁵²

After this public embarrassment, Merck turned tail on its strategy to push school mandates. But a handful of states had already passed laws, and the seed was planted.

“[S]chool-based vaccination strategies in the U.S. have mainly focused on vaccine policy mandates for school entry, which were met with resistance in most states due to concerns about adolescent sexual promiscuity and pushback from anti-vaccine groups.”⁵³

They needed a new strategy. The heavy hand of mandates was not working, for many reasons. The shot is too controversial because it targets a virus that is sexually transmitted. Intimate and private topics like that typically create a fervor that ignites a family’s passion for choice. Further, the web of influence that pharma has over the government was exposed in Texas, leaving a bad taste in everyone’s mouth. Gardasil had to be sold in a more subtle way — they needed to make the kids want it, to ask their parents for it, to expect it from them to prevent cancer, to guilt and pressure parents into saying yes, even if they had doubts. This need to convince children to ask for a vaccine is why it is so important parents and legislatures stay vigilant about the coming wave of School-based Health Centers. Review Part 1 for more details on the HPV shot push in places intended to be a “medical home” for our children.

Side effects of the vaccine

When you look at statistics from the Vaccine Injury Compensation Program (VICP), you could conclude that, dose for dose, the HPV shot is one of the most dangerous vaccines we give our children. As of September 1, 2024, the Health Resources and Services Administration (HRSA) reports 158,878,541 doses of HPV vaccine have resulted in 659 total claims, with only 179 compensated.⁵⁴ While this number may seem small, remember it’s estimated that as little as 10% or even 1% of vaccine injuries are reported. It is very difficult to get into the VICP. If you compare other vaccines with similar dose distribution, the numbers are clearer — HPV doses have resulted in six times more claims than other shots on the schedule.

Vaccine	Doses since 2006	Total Vaccine Court Claims
HPV	158,878,541	659
HIB	159,451,493	30
Meningococcal	152,566,593	102
Rotavirus	150,866,652	82
Varicella	143,906,028	84

You can also see that the HPV vaccines have caused a very high number of reports to VAERS, considering their relatively low dosage distribution (compare influenza at over 2.4 million), and having only been on the market since 2006, whereas other vaccines in VAERS have been around for years or decades more.⁵⁵

What are the injuries suffered after Gardasil vaccines? SaneVax compiled a list after analyzing VAERS data that includes death, disability, cervical cancer, and infertility.⁵⁶

People have made specific injury claims such as: premature ovarian failure, premature menopause,⁵⁷Postural Orthostatic Tachycardia Syndrome (POTS), and autoimmune disease.⁵⁸

Will there be consequences for Merck or the federal government?

Dr. Sin Hang Lee discovered the vaccines are contaminated with DNA fragments, which are not supposed to be there. Based on this, he concluded that HPV vaccination increases the level of cytokines (immune response) at the site of injection more than other vaccines.

In January 2016, Lee sent an open letter to the World Health Organization, the CDC, the Japanese Ministry of Health, and the Global Advisory Committee on Vaccine Safety.⁵⁹ After extensive research, he believes these organizations are guilty of manipulating data and suppressing science to maintain an illusion that the HPV vaccine is safe.

Lee called out scientific misconduct in this 15-page letter with primary sourced emails from FOIAs, and 22 cited references (including his own scientific research). He sent this letter in response to a hearing held in Japan about safety concerns. In 2013, the Japanese government began recommending the shot in their national immunization program, but quickly detected a large number of adverse events.⁶⁰ Japan decided to suspend its recommendation of the shot for children and to investigate further. After almost a decade of advocacy work by the injured and activists, the declared COVID pandemic was a death knell to the movement. The HPV shot was recommended again in 2022,⁶¹ because “there was no reason not to.”⁶²

The recommendation may be back, but that advocacy work was not lost. Science magazine reported: “Many parents are still wary, and local governments and health care providers will have to convince them of the vaccines’ benefits. … [A]dvocates are not giving up.” And a 2024 study found “HPV vaccination coverage in Japan is extremely low and is estimated to fall short of the World Health Organization target [of 90% coverage] in FY 2028.”

What about the lawsuits?

As of September 2024, a massive litigation effort is underway to hold Merck accountable for its claims that the HPV vaccine is safe and effective. Plaintiffs are bringing forth evidence that Merck misled everyone and “knowingly concealed the risks associated with Gardasil’s ingredients.”⁶³ Plaintiffs assert it was not transparent for Merck to create a direct association between HPV and cancer, and that Merck never proved the vaccine could prevent cervical cancer. They will present evidence that Gardasil adds insult to injury by being the most expensive vaccine on the market despite having more reported injuries than any other.

Plaintiffs suing in federal court first had to jump through the hoops of the VICP. Though it’s a long, arduous process,⁶⁴ some were able to appeal their losses to the federal court system. Cases around the country were eventually consolidated into one case centered in the Western District of North Carolina.⁶⁵

There are 200 plaintiffs and counting as of September 2024, and 16 bellwether cases are being worked through by the court, which will guide litigation for the remaining hundreds as that number continues to grow.⁶⁶ The first test case is scheduled to be heard in California in October 2024.

Conclusion

Merck used its power and resources to secretly fund what appeared to be a public health awareness campaign to link HPV to cancer. It created a “social problem through the management of science and the media” which translated into social control and had an impact on public health.⁶⁷

The story of Gardasil fills volumes. We could explore so much more; a mountain of evidence and information is available about this shady shot. But we hope this two-part series, “Shining a light on HPV,” gave you enough breadcrumbs to follow as you do further research and come to your own conclusion about what’s right for you and your children.

When you look at the story of Gardasil, what lessons do you think Merck learned from Vioxx? You’ll recall that Merck promoted Vioxx for uses other than those licensed. Merck also lied to its shareholders, the FDA, and the public about how dangerous the drug was. Does it seem like the playbook changed for Gardasil?

Another question to ponder as we close this story: Are these the lessons Kathryn Jansen brought to Pfizer when making the COVID shot?

---

REFERENCES

1. “Global Revenue of Gardasil and Cervarix from 2006–2018.” PLOS ONE, https://www.researchgate.net/figure/Global-revenue-of-Gardasil-and-Cervarix-from-2006-2018_tbl1_348414634. ,
   “Merck Mystified by Sudden ‘step Down’ in Gardasil Sales in China.” Fierce Pharma, (2024). https://www.fiercepharma.com/pharma/merck-mystified-sudden-step-down-gardasil-sales-china#:~:text=The%20recent%20revenue%20increase%20for,a%2014%25%20increase%20in%20sales. ↩︎
2. “Top Selling Products of Merck & Co. Based on Revenue in 2023.” Statista, (2024). https://www.statista.com/statistics/272367/revenues-of-merck-and-co-top-selling-drugs/. ↩︎
3. Prakash, Snigdha, and Vikki Valentine. “Timeline: The Rise and Fall of Vioxx.” NPR, (2007). https://www.npr.org/2007/11/10/5470430/timeline-the-rise-and-fall-of-vioxx. ↩︎
4. “Merck Manipulated the Science about the Drug Vioxx.” Union of Concerned Scientists, (2017). https://www.ucsusa.org/resources/merck-manipulated-science-about-drug-vioxx. ↩︎
5. Mayor, Susan. “Rofecoxib Caused Excess Heart Disease.” BMJ 330, no. 7485 (2005). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC546095/. ↩︎
6. “Merck Settles Class-action Case over Vioxx for $830M.” CBS News, (2016). https://www.cbsnews.com/news/merck-settles-class-action-case-over-vioxx-for-830m/. ↩︎
7. “Step 3: Clinical Research.” FDA: The Drug Development Process, (2018). https://www.fda.gov/patients/drug-development-process/step-3-clinical-research. ↩︎
8. Holland, Mary M.A., J.D, Kim M. Rosenberg J.D, and Eileen Iorio. 2018. The HPV Vaccine On Trial: Seeking Justice For A Generation Betrayed. Skyhorse, page 49. ↩︎
9. “Fast Track.” FDA, (2024). https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track. ↩︎
10. Gallego, Lucia S, et al. “Human Papilloma Virus Vaccine.” StatPearls, (2024). https://www.ncbi.nlm.nih.gov/books/NBK562186/#:~:text=9vHPV%20(9%2Dvalent%20vaccine)%3A,against%20these%20specific%20HPV%20types. ↩︎
11. Holland, Mary M.A., J.D, Kim M. Rosenberg J.D, and Eileen Iorio. 2018. The HPV Vaccine On Trial: Seeking Justice For A Generation Betrayed. Skyhorse, page 45. ↩︎
12. Blaxill, Mark. “A License to Kill? Part 2: Who Guards Gardasil’s Guardians?” Age of Autism. https://www.ageofautism.com/2010/05/a-license-to-kill-part-2-who-guards-gardasils-guardians.html. ↩︎
13. Grantham, Susan, et al. “Merck’s One Less Campaign: Using Risk Message Frames to Promote the Use of Gardasil® in HPV Prevention.” Communication Research Reports, (2011). https://sci-hub.st/10.1080/08824096.2011.616243. ↩︎
14. Crosswell, Laura, and Lance Porter. 2018. Politics, Propaganda, and Public Health: A Case Study in Health Communication and Public Trust. Lexington Books. https://rowman.com/ISBN/9781498553001/Politics-Propaganda-and-Public-Health-A-Case-Study-in-Health-Communication-and-Public-Trust. ,
    Gottlieb, S D. 2018. Not Quite a Cancer Vaccine: Selling HPV and Cervical Cancer. https://www.goodreads.com/en/book/show/35086608-not-quite-a-cancer-vaccine. ↩︎
15. Wolfe, Nicole E. “A Case Study of the Development and Promotion of the Gardasil Vaccine.” UC San Francisco Electronic Theses and Dissertations, (2009). https://escholarship.org/uc/item/0hb8v7j3. ↩︎
16. “Brand of the Year.” Pharmaceutical Executive, (2007). https://www.pharmexec.com/view/brand-year-0. ↩︎
17. Buttweiler, Brittney L. “Because We Have the Power to Choose: A Critical Analysis of the Rhetorical Strategies Used in Merck’s Gardasil Campaign.” ScholarWorks at University of Montana, (2009). https://scholarworks.umt.edu/cgi/viewcontent.cgi?article=1108&context=etd. ↩︎
18. Wolfe, Nicole E. “A Case Study of the Development and Promotion of the Gardasil Vaccine.” UC San Francisco Electronic Theses and Dissertations, (2009). https://escholarship.org/uc/item/0hb8v7j3. ↩︎
19. Wolfe, Nicole E. “A Case Study of the Development and Promotion of the Gardasil Vaccine.” UC San Francisco Electronic Theses and Dissertations, (2009). https://escholarship.org/uc/item/0hb8v7j3. ↩︎
20. “Brand of the Year.” Pharmaceutical Executive, (2007). https://www.pharmexec.com/view/brand-year-0. ↩︎
21. Buttweiler, Brittney L. “Because We Have the Power to Choose: A Critical Analysis of the Rhetorical Strategies Used in Merck’s Gardasil Campaign.” ScholarWorks at University of Montana, (2009). https://scholarworks.umt.edu/cgi/viewcontent.cgi?article=1108&context=etd. ↩︎
22. Grantham, Susan, et al. “Merck’s One Less Campaign: Using Risk Message Frames to Promote the Use of Gardasil® in HPV Prevention.” Communication Research Reports, (2011). https://sci-hub.st/10.1080/08824096.2011.616243. ↩︎
23. “Patient Information about GARDASIL®9.” Merck, (2024). https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf. ↩︎
24. Redmond, Malika A. “A Critical Discourse Analysis of the Marketing of Merck & Co.’s Human Papillomavirus Vaccine Gardasil®.” ScholarWorks at Georgia State University, (2011). https://scholarworks.gsu.edu/cgi/viewcontent.cgi?article=1028&context=wsi_theses, page 28. ↩︎
25. Armstrong, Jennifer K. “Spice Girls’ ‘Wannabe’: How ‘Girl Power’ Reinvigorated Mainstream Feminism in the ’90s.” Billboard, July 15, 2016. https://www.billboard.com/music/features/spice-girls-wannabe-girl-power-feminism-7439005/. ↩︎
26. Grantham, Susan, et al. “Merck’s One Less Campaign: Using Risk Message Frames to Promote the Use of Gardasil® in HPV Prevention.” Communication Research Reports, (2011). https://sci-hub.st/10.1080/08824096.2011.616243. ↩︎
27. Attkisson, Sharyl. “Gardasil Researcher Speaks Out.” CBS News, (2009). https://www.cbsnews.com/news/gardasil-researcher-speaks-out/. ↩︎
28. Blaxill, Mark. “A License to Kill? Part 2: Who Guards Gardasil’s Guardians?” Age of Autism. https://www.ageofautism.com/2010/05/a-license-to-kill-part-2-who-guards-gardasils-guardians.html. ↩︎
29. “Summary Report.” Advisory Committee on Immunization Practices, (2009). https://www.cdc.gov/vaccines/acip/meetings/downloads/min-archive/min-2009-10-508.pdf. ↩︎
30. Levinson, Daniel R. “CDC’S Ethics Program for Special Government Employees on Federal Advisory Committees.” Department of Health and Human Services, (2011). https://oig.hhs.gov/documents/evaluation/2517/OEI-04-07-00260-Complete%20Report.pdf. ↩︎
31. Blaxill, Mark. “A License to Kill? Part 2: Who Guards Gardasil’s Guardians?” Age of Autism. https://www.ageofautism.com/2010/05/a-license-to-kill-part-2-who-guards-gardasils-guardians.html. ↩︎
32. Erickson, Norma. “HPV Vaccines: Betrayal of the Public Trust?” SaneVax, Inc., (2013). https://sanevax.org/hpv-vaccines-betrayal-of-the-public-trust/. ↩︎
33. “Top 20 Commercially Successful Inventions.” National Institutes of Health. https://www.techtransfer.nih.gov/reports/top-20-commercially-successful-inventions. ↩︎
34. The Canary Party, https://canaryparty.org/. ↩︎
35. Blaxill, Mark. “A License to Kill? Part 1: How A Public-Private Partnership Made the Government Merck’s Gardasil Partner.” Age of Autism. https://www.ageofautism.com/2010/05/a-license-to-kill-part-1-how-a-publicprivate-partnership-made-the-government-mercks-gardasil-partner.html. ↩︎
36. Blaxill, Mark. “A License to Kill? Part 1: How A Public-Private Partnership Made the Government Merck’s Gardasil Partner.” Age of Autism. https://www.ageofautism.com/2010/05/a-license-to-kill-part-1-how-a-publicprivate-partnership-made-the-government-mercks-gardasil-partner.html. ↩︎
37. “Cancer Prevention Message Is Key for HPV Vaccination Discussions with Parents.” Cancer Currents, (2018). https://www.cancer.gov/news-events/cancer-currents-blog/2018/hpv-vaccine-parents-prevention-best-message. ↩︎
38. “Increase the Proportion of Adolescents Who Get Recommended Doses of the HPV Vaccine — IID‑08.” Healthy People 2030. https://health.gov/healthypeople/objectives-and-data/browse-objectives/vaccination/increase-proportion-adolescents-who-get-recommended-doses-hpv-vaccine-iid-08. ↩︎
39. “HPV Vaccination.” Healthy People 2030, (2020). https://health.gov/healthypeople/tools-action/browse-evidence-based-resources/hpv-vaccination. ↩︎
40. National HPV Vaccination Roundtable. American Cancer Society, https://hpvroundtable.org/. ↩︎
41. “HPV Vaccine Recommendations.” National HPV Vaccination Roundtable. American Cancer Society, https://hpvroundtable.org/hpv-vaccines-recommendations/. ↩︎
42. “Provider Education Series Videos.” National HPV Vaccination Roundtable. American Cancer Society, https://hpvroundtable.org/provider-education-series-videos/. ↩︎
43. “2023 National Meeting.” National HPV Vaccination Roundtable. American Cancer Society, https://hpvroundtable.org/2023-national-meeting/#. ↩︎
44. Saul, Stephanie, and Andrew Pollack. “Furor on Rush to Require Cervical Cancer Vaccine.” The New York Times, February 17, 2007. https://www.nytimes.com/2007/02/17/health/17vaccine.html. ↩︎
45. “Examining the FDA’S HPV Vaccine Records.” Judicial Watch, (2008). https://www.judicialwatch.org/wp-content/uploads/2019/08/JWReportFDAhpvVaccineRecords.pdf. ↩︎
46. Saul, Stephanie, and Andrew Pollack. “Furor on Rush to Require Cervical Cancer Vaccine.” The New York Times, February 17, 2007. https://www.nytimes.com/2007/02/17/health/17vaccine.html. ↩︎
47. “Provider Education Series Videos.” National HPV Vaccination Roundtable. American Cancer Society, https://hpvroundtable.org/provider-education-series-videos/. ↩︎
48. “National and State-Level HPV Vaccination Coverage.” ACIP, (2022). https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-06-22-23/02-HPV-Stokley-508.pdf. ↩︎
49. “Michele Bachmann Correct to Criticize Gardasil Mandate, Doctors Say.” PR Newswire, (2011). https://www.prnewswire.com/news-releases/michele-bachmann-correct-to-criticize-gardasil-mandate-doctors-say-129824558.html. ↩︎
50. Redmond, Malika A. “A Critical Discourse Analysis of the Marketing of Merck & Co.’s Human Papillomavirus Vaccine Gardasil®.” ScholarWorks at Georgia State University, (2011). https://scholarworks.gsu.edu/cgi/viewcontent.cgi?article=1028&context=wsi_theses, page 13. ↩︎
51. Edwards, Jim. “Rick Perry’s Gardasil U-Turn: Here’s What Actually Happened Back in 2007.” CBS News, (2011). https://www.cbsnews.com/news/rick-perrys-gardasil-u-turn-heres-what-actually-happened-back-in-2007/. ↩︎
52. Holland, Mary M.A., J.D, Kim M. Rosenberg J.D, and Eileen Iorio. 2018. The HPV Vaccine On Trial: Seeking Justice For A Generation Betrayed. Skyhorse, page 126. ↩︎
53. Shin, Michelle B, et al. “Multilevel Perspectives on School-based Opportunities to Improve HPV Vaccination among Medically Underserved Adolescents: Beyond School Entry Mandates.” Human Vaccines and Immunotherapeutics, (2023). https://pubmed.ncbi.nlm.nih.gov/37666253/. ↩︎
54. “Data & Statistics.” Health Resources & Services Administration, (2024). https://www.hrsa.gov/sites/default/files/hrsa/vicp/vicp-stats-9-1-24.pdf. ↩︎
55. “About The Vaccine Adverse Event Reporting System (VAERS).” CDC Wonder. https://wonder.cdc.gov/controller/datarequest/D8. ↩︎
56. “Events Reported To VAERS After HPV Vaccines Through Dec 14, 2019.” SaneVax, (2020). https://sanevax.org/wp-content/uploads/2020/01/Dec-2019.pdf. ↩︎
57. “Gardasil Lawsuit.” Miller & Zois Attorneys at Law, (2024). https://www.millerandzois.com/products-liability/gardasil/. ↩︎
58. “Gardasil Lawsuit.” Miller & Zois Attorneys at Law, (2024). https://www.millerandzois.com/products-liability/gardasil/. ↩︎
59. Lee, Sin H. MD. “Allegations of Scientific Misconduct by GACVS/WHO/CDC Representatives Et Al.” SaneVax, (2016). https://sanevax.org/wp-content/uploads/2016/01/Allegations-of-Scientific-Misconduct-by-GACVS.pdf. ↩︎
60. Okita, Taketoshi, et al. “The Controversy on HPV Vaccination in Japan: Criticism of the Ethical Validity of the Arguments for the Suspension of the Proactive Recommendation.” Health Policy 124, no. 2 (2020): 199-204. https://www.sciencedirect.com/science/article/abs/pii/S0168851019303057. ↩︎
61. Ujiie, Mugen. “Resumption of Active Recommendation of the Human Papillomavirus Vaccine in Japan and Future Challenges for the National Immunization Program.” Human Vaccines And Immunotherapeutics 18, no. 6 (2022). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9746481/. ↩︎
62. Normile, Dennis. “Japan Relaunches Its HPV Vaccination Drive. For Thousands of Women, It May Be Too Late.” Science, (2022). https://www.science.org/content/article/japan-relaunches-its-hpv-vaccination-drive-thousands-women-it-may-be-too-late#:~:text=In%202020%20and%202021%2C%20a,vaccines%20as%20well%2C%20Hanley%20says. ↩︎
63. Normile, Dennis. “Japan Relaunches Its HPV Vaccination Drive. For Thousands of Women, It May Be Too Late.” Science, (2022). https://www.science.org/content/article/japan-relaunches-its-hpv-vaccination-drive-thousands-women-it-may-be-too-late#:~:text=In%202020%20and%202021%2C%20a,vaccines%20as%20well%2C%20Hanley%20says. ↩︎
64. “HPV Vaccine on Trial: Gardasil Claims in the Vaccine Injury Compensation Program.” Children’s Health Defense. November 18, 2023. Video, https://rumble.com/v3wiik0-hpv-vaccine-on-trial-gardasil-claims-in-the-vaccine-injury-compensation-pro.html. ↩︎
65. Miller, Ronald V. Jr. “Gardasil HPV Vaccine Lawsuit.” Lawsuit Information Center, (2024). https://www.lawsuit-information-center.com/gardasil-hpv-vaccine-lawsuit.html. ↩︎
66. “Gardasil Vaccine Lawsuit.” The Lanier Law Firm, (2024). https://www.lanierlawfirm.com/gardasil-vaccine-lawsuit/. ↩︎
67. Wolfe, Nicole E. “A Case Study of the Development and Promotion of the Gardasil Vaccine.” UC San Francisco Electronic Theses and Dissertations, (2009). https://escholarship.org/uc/item/0hb8v7j3. ↩︎