After more than a decade of California legislators trying to mandate Merck’s HPV (human papillomavirus) vaccine for children as young as age nine, Assemblywoman Cecilia Aguiar-Curry (D-Winters) has produced a bill with language that implies the vaccine is required but comes short of actually requiring it. AB 659, called the “Cancer Prevention Act,” was sent to Governor Gavin Newsom on September 20. He has until mid-October to sign or veto it.
Concerned parents and medical professionals had mobilized to modify the original bill, which sought to mandate the controversial HPV vaccine, known commercially by the name Gardasil, for all 8th graders and college students. It made no provision for personal or religious exemptions.
Amendments to AB 659 first changed the requirement to “recommended,” then finally, to “advised” children “to adhere to current immunization guidelines” for the HPV (human papillomavirus) before advancing to 8th grade. However, the bill requires that beginning in 6th grade, parents will receive notifications about getting the HPV vaccine, not from their pediatricians, but from school districts. For now, all references to college students were dropped.
Many states have attempted to pass similar legislation since the HPV vaccine was authorized in 2006 by the Food and Drug Administration. Until now, only the District of Columbia and three states – Hawaii, Rhode Island and Virginia – have been able to require the vaccine while allowing some form of exemption. All other attempts have failed. But with Merck’s patent on the HPV vaccine expiring in 2028, the time frame for Merck to enjoy profits from the high vaccination numbers it expected is narrowing.
According to 2022 data from the Centers for Disease Control, common adolescent vaccines for youth aged 13-17 are accepted by 80 or 90 percent of the population. But only 76 percent had received 1 HPV vaccine dose, and just 62.6 percent were up to date with their HPV vaccinations, which are a 2- or 3-dose series. Scientists have been trying to figure out why HPV vaccinations are low.
On August 19, 2010, an article titled “HPV Vaccination Mandates — Lawmaking amid Political and Scientific Controversy” published in The New England Journal of Medicine concluded, “Although Merck’s lobbying was a key catalyst in the initial push for mandates, many stakeholders came to view the company’s efforts as a liability. As media coverage called attention to the company’s aggressive tactics, suspicion grew that policy decisions were not being based on the product’s merits, and people who were otherwise supportive pulled back. The belief that mandate bills were an effort to make money for the company overshadowed whatever principled arguments might exist for them.”
Fortune 500 magazine listed Merck as the fourth most profitable pharmaceutical company in 2022, with $51.2 billion in revenue. Of the 18 routine vaccines recommended for children, Merck makes 10 of them. They include Ebola, HepA (hepatitis A), HepB (hepatitis B), Hib (Haemophilus influenzae type B), MMR (measles, mumps, rubella), Pneumococcal (pneumonia), RV5 (rotavirus), and Varicella (chickenpox). Four of the vaccines are produced exclusively by Merck, MMR and Varicella.
“There have been numerous concerns about the need for and efficacy of Gardasil since 2006.”
There have been numerous concerns about the need for and efficacy of Gardasil since 2006. In a letter of opposition to AB 659 dated March 5, 2023, the founder and president of Physicians for Informed Consent, Dr. Shira Miller, cited the following facts:
“1. Human papillomavirus (HPV) is a virus, with over 200 different types, which is transmitted sexually, generally causes no symptoms, and 90% of the time resolves spontaneously within two years.
“2. Cervical cancer, representing 0.7 percent of all cancers, is the most common HPV-related cancer and most frequently occurs in women aged 35–49 (average age of diagnosis is 50) — it is rarely diagnosed in women younger than 20, and is six times more common in women with HIV. Together, Pap and HPV testing can successfully screen 95 percent of potential cervical cancers.
“3. In California, between 1999–2019, there have been about 400–500 cervical cancer deaths every year, which is a rate of about 2.1–2.9 per 100,000. Overall, 97 percent of deaths from HPV-related cancers are in high-risk populations (i.e., smoking, women not screened every three years, and risky sexual behavior), and the annual risk of an average-risk person dying from an HPV-related cancer is about 1 in 900,000.
“4. The currently available HPV vaccine consists of proteins (virus-like particles) made from yeast through recombinant DNA technology for nine different types of HPV, and 500 mcg of aluminum,12 which are injected intramuscularly in three separate doses.
“5. The HPV vaccine was first approved in 2006 after clinical trials; however, the placebo was not inert and contained aluminum, and serious adverse events have been reported, so its safety is controversial and currently being litigated in California.
“6. The purpose of the HPV vaccine is to prevent HPV-related genital warts and cancers and its effectiveness up to 11 years has been demonstrated. However, as it takes 15–20 years to develop cervical cancer in most women, more time and research are needed before definitive effectiveness claims can be made.
“7. Since for most people the chance of dying from an HPV-related cancer is about 1 in 900,000, and safety studies of HPV vaccines include only about 25,000 subjects, there is not enough statistical power to conclude that the HPV vaccine is safer than the risk of HPV-related cancers.”
California-based Wisner Baum (formerly Baum Hedlund Aristei & Goldman) was recently designated co-lead counsel for 94 plaintiffs as part of a multi-district litigation suit against Merck. More cases are expected to be filed soon. Separately, another 100 claims have been or soon will be filed against the Vaccine Injury Compensation Program (VICP).
Earlier this year, Merck was ordered by a federal court to release clinical trial data in preparation for court proceedings expected in 2024 or 2025.
On their website, Wisner Baum gave a Gardasil Vaccine Lawsuit update in October 2023, where they addressed the question, “What Is the Gardasil Controversy?” “Underlying the entire Gardasil controversy are clinical trials (human testing) that victims allege were fraudulently conducted and reported.”
In December 2017, the study “Serious adverse events associated with HPV vaccination,” published by the University of Adelaide in Australia, found under “Discussions and Conclusions” that “The major concern with the body of RCT [randomised controlled trial] evidence collated is the lack of standard definition of what constitutes an SAE [serious adverse event]. Most trials did not define the SAEs they collected, how they would collect them or whether the collection of data was blinded to treatment allocation.”
The Association of American Medical Colleges published an article on March 21, 2023, titled “Partnering With Parents To Address Vaccine Concerns,” which acknowledged that “several vaccinations provoke some degree of hesitancy. That’s due to everything from complacency to misinformation. This means getting patients over the finish line requires strategy and finesse.”
The article also shares, to improve acceptance, Sean O’Leary, MC, MPH, professor of pediatrics at the University of Colorado School of Medicine and Children’s Hospital Colorado, says, “We recommend introducing a vaccine by saying, ‘We have one shot to do today’ as opposed to ‘What do you think about this vaccine?’… When the pediatrician or family doctor frames it along the lines of this is what we do, it’s the right thing to do, the parent can then be more comfortable in the decision to vaccinate.”
The National Cancer Institute, in a 2021 article titled, “Despite Proven Safety of HPV Vaccines, More Parents Have Concerns,” quoted a study published in JAMA on September 17 of an HPV study that put the blame of vaccine hesitancy on parents doing their own research.
“Our suspicion is that the rising safety concerns are probably being driven by [the] use of social media and people trying to find vaccine information online,” said the study’s lead researcher, Kalyani Sonawane, Ph.D., of UTHealth School of Public Health in Houston, Texas.
Even abortion provider Planned Parenthood is concerned about the low vaccination rates. Last month, on September 25, 2023, Boston Globe staff writer Brittany Bowker reported, “Planned Parenthood of Southern New England is seeing a ‘concerning decline’ in vaccination rates for human papillomavirus, or HPV, with vaccinations down roughly 40 percent over the past few years, according to health experts from the organization.”
The Globe article also cited a study on the politics of vaccines. The authors said, “Understanding the association between political ideology and HPV awareness is important for tailoring public health interventions to different political groups to increase vaccine uptake.”
Last year, Senators Scott Wiener (D-San Francisco) and Richard Pan (D-Sacramento) introduced legislation that would have allowed minors as young as 12 to consent to these vaccines. Though the age of consent was amended to 15, the bill was sent to the inactive file at the end of last year’s session.
Assemblywoman Aguiar-Curry, author of AB 659, received a $4,900 campaign contribution from Merck on February 16, 2023, just seven days after she introduced the bill. Donations from health industry donors make up the second largest sector of contributions to Aguiar-Curry during her seven-year career in the State Assembly.
During the first six months of 2023, AB 659 co-sponsor Blanca Rubio (D-West Covina) received $30,000 from the Pharmaceutical Research and Manufacturers Association of America (PRMAA) PAC (political action committee) and a $1,200 contribution from Takeda Pharmaceuticals who has a manufacturing facility in Thousand Oaks. Assemblywoman Wendy Carrillo (D-Los Angeles) received $5,100 from the PRMAA PAC. Assemblywoman Diane Papan (D-San Mateo) received $2,000 from PRMAA PAC. Merck contributed $2,000 to Senator Wiener.
