Tag: cervical cancer

Is Gardasil Helping Merck Pay for Vioxx Lawsuits?

Why do some folks think that the Gardasil vaccine is being pushed to help Merck pay for their Vioxx lawsuits?

The latest anti-vax conspiracy theory from Bobby Kennedy.
The latest anti-vax conspiracy theory from Bobby Kennedy.

The usual suspects…

Is Gardasil Helping Merck Pay for Vioxx Lawsuits?

Could it be true?

“Three years after withdrawing its pain medication Vioxx from the market, Merck has agreed to pay $4.85 billion to settle 27,000 lawsuits by people who claim they or their family members suffered injury or died after taking the drug, according to two lawyers with direct knowledge of the matter.”

Merck Agrees to Settle Vioxx Suits for $4.85 Billion

Merck settled most of those lawsuits in 2007.

“But for Merck, which has already spent more than $1.2 billion on Vioxx-related legal fees, the settlement will put to rest any fears that Vioxx lawsuits might bankrupt the company, or even have a significant financial impact. While eye-popping, the settlement payment represents less than one year’s profits for the company, the third-largest American drug maker.”

Merck Agrees to Settle Vioxx Suits for $4.85 Billion

All together, Merck has paid more than $8.5 billion to settle litigation and pay fines and legal costs.

“Merck’s recovery is proceeding as planned. The stock is up from $44 when we wrote about it to just shy of $55 on Oct. 22, a gain of nearly 25%. The latest push came from strong third-quarter earnings aided by robust sales of Gardasil, new diabetes pill Januvia, and asthma drug Singulair. The company’s cost-cutting program also helped.”

Update: Merck recovers from Vioxx

And they long ago recovered from the lawsuits, with their stock price now at about $87, reaching multi-year highs.

Is Gardasil driving their profits?

“Our performance in 2007 shows that the customer-focused, more efficient business model we began implementing more than two years ago is working,” said Richard T. Clark, chairman, president and chief executive officer. “We have a strong portfolio of products, a robust pipeline of potential new therapies and a leadership team focused daily on improving operational performance. This positions us to build on our record of delivering essential breakthrough medicines and vaccines like JANUVIA, ISENTRESS and GARDASIL to the global marketplace.”

Merck Announces 2007 Financial Results Reflecting Revenue Growth from Key Products

It certainly didn’t hurt, but Merck’s biggest seller is now the “blockbuster” cancer drug Keytruda.

Back in 2007, it was Singulair, which is now generic.

Gardasil makes up a smaller percentage of Merck’s total sales.

Anyway, profits from Gardasil have been rising in recent years because of sales in China and Europe, not mandates in the United States.

  • Keytruda – $3.07 billion in the last quarter
  • Gardasil / Gardasil 9 – $1.32 billion
  • Januvia / Janumet – $1.31 billion
  • Proquad/M-M-R II/ Varivax – $623 million
  • Bridion – $280 million
  • Isentress / Isentress HD – $250 million
  • Nuvaring – $241 million
  • Pneumovax 23 – $237 million
  • Simponi – $203 million
  • Implanon / Nexplanon – $199 million

But did Merck really have a “HPV: Help Pay for Vioxx” plan?

Where is the document from Merck that says "this time we have no liability and we can't get caught?"
Where is the document from Merck that says “this time we have no liability and we can’t get caught?”

Did their recovery require Gardasil becoming mandatory around the world?

Kennedy’s Help Pay for Vioxx Bombshell is a Dud

With just a little research, it is easy to review Merck’s plan after Vioxx.

“I tell the (Merck) organization if you want Vioxx off the front page, if you want it out of the news, we have to put Gardasil on the front page and have to put Januvia on the front page,” Richard Clark, Merck’s CEO said at the Reuters Summit in New York on Wednesday.

It included closing five manufacturing plants and 3 research laboratories and laying off 11 percent of its work force. And introducing new drugs and vaccines, including Januvia, Isentress, Keytruda, and yes, Gardasil.

But since there are currently mandates for Gardasil in just two states, Rhode Island and Virginia, and the District of Columbia, it is pretty obvious that their recovery didn’t hinge on vaccine mandates.

Still, since Gardasil is approved and recommended for children when they are 11 to 12 years old, it shouldn’t be surprising that Merck did lobby state legislatures to make it mandatory, like other vaccines that are needed to attend school.

And as much as folks like Bobby Kennedy wish there was a new scandal, it is very easy to see that Merck is doing well because they have a vaccine that prevents cancer, a drug that treats cancer, and other important products.

“One activist who frequently criticizes pharmaceutical companies, Vera Hassner Sharav, and a co-author suggested that the H.P.V. vaccine stood for a campaign to “Help Pay for Vioxx” losses. “

Furor on Rush to Require Cervical Cancer Vaccine

What’s really surprising is that Bobby Kennedy‘s bombshell “Help Pay for Vioxx” idea isn’t even new.

“A fourth factor that soured many policymakers on mandates was consternation over the involvement of the vaccine’s manufacturer, Merck, in the policy process. Merck undertook a multifaceted marketing campaign to promote the passage of mandate legislation. Representatives of the company met with legislators and hired political consultants to promote the vaccine. Merck also provided unrestricted funds to Women in Government, a national organization of female legislators. Many of the bills to require HPV vaccination were introduced by Women in Government members.

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.”

Colgrove et al on HPV Vaccination Mandates — Lawmaking amid Political and Scientific Controversy

An article in the New York Times talked about it way back in 2007…

Merck is doing very well even though Gardasil is only mandated in two states and Washington D.C.
Merck is doing very well even though Gardasil is only mandated in two states and Washington D.C.

It sure does sound scarier to say that you discovered all of this during a lawsuit instead of a simple Google search though. But that’s how propaganda works.

#SaidNoDoctor, except Dr. Jay Gordon, who made this statement about the HPV vaccine on the Ricki Lake Show.
#SaidNoDoctor, except Dr. Jay Gordon, who made this statement about the HPV vaccine on the Ricki Lake Show. Although he says he has changed his mind and now recommends it, how many kids weren’t vaccinated and are at risk to develop cervical cancer because their parents listened to him and they weren’t vaccinated?

Fortunately, many parents aren’t buying it anymore.

“Coverage estimates for HPV vaccination are low despite evidence of the vaccine’s effectiveness and safety. This large pool of unvaccinated adolescents in the United States means that considerable public health benefits are not being realized; many vaccine-preventable cancers caused by HPV will occur… Mandating HPV vaccination for school entry is a move that will protect the public’s health by preventing HPV-related morbidity and mortality.”

Barraza et al on Human Papillomavirus and Mandatory Immunization Laws

They know that HPV vaccines are safe, with few risks, and more and more are vaccinating their kids, although even more kids would get vaccinated and protected if Gardasil was finally mandated like other vaccines.

More on Gardasil and Vioxx Lawsuits

Will a NY Law Make the HPV Vaccine Mandatory for Daycare?

Why do some folks think that a proposed bill in New York will make the HPV vaccine mandatory for kids in daycare?

A NY law will not make the HPV vaccine mandatory for kids in daycare.
Kids in daycare will not need to get the HPV vaccine if S298 passes in New York.

Unfortunately, this time the misinformation isn’t just coming from the usual sources. Local news stations are getting in on the action too.

Will a NY Law Make the HPV Vaccine Mandatory for Daycare?

While Senate Bill S298A does “Provides for the immunization of all children born after January 1, 2008 against the human papillomavirus (HPV),” it doesn’t say anything about a mandate for kids in daycare.

“Section one amends the section heading and subdivisions 2; 3, 5, 6, 7, and 8 of section 2164 of the public health law, as amended by chapter 401 of the laws of 2015, by adding human papillomavirus (HPV) to the list of required immunizing agents, such as those against poliomyelitis, mumps and measles, to be administered to children in this state. Section one also adds the HPV vaccine to the list of vaccines for which a booster is required;”

Senate Bill S298A 2019-2020 Legislative Session

When would they get it?

“Every person in parental relation to a child in this state shall have administered to such child an adequate dose or doses of an immunizing agent against poliomyelitis, mumps, measles, diphtheria, rubella,varicella, HUMAN PAPILLOMAVIRUS (HPV), Haemophilus influenzae type b (Hib), pertussis, tetanus, pneumococcal disease, and hepatitis B, which meets the standards approved by the United States public health service for such biological products, and which is approved by the department under such conditions as may be specified by the public health council.”

Senate Bill S298A 2019-2020 Legislative Session

Like the other vaccines, they would almost certainly get it at the standard age, when they are 11 or 12 years old.

“Every person in parental relation to a child in this state born on or after January first, nineteen hundred ninety-four and entering sixth grade or a comparable age level special education program with an unassigned grade on or after September first, two thousand seven, shall have administered to such child a booster immunization containing diphtheria and tetanus toxoids, [and] an acellular pertussis vaccine, AND A HUMAN PAPILLOMAVIRUS (HPV) VACCINE, which meets the standards approved by the United States public health service for such biological products, and which is approved by the department under such conditions as may be specified by the public health council.”

Senate Bill S298A 2019-2020 Legislative Session

And they would get their second booster dose in the sixth grade.

So why do some folks think the bill includes a mandate for daycare?

“The term “school” means and includes any public, private or parochial child caring center, day nursery, day care agency, nursery school, kindergarten, elementary, intermediate or secondary school.”

Senate Bill S298A 2019-2020 Legislative Session

The term day care is used in the definitions list at the beginning of the bill…

“The term “child” shall mean and include any person between the ages of two months and eighteen years.”

Senate Bill S298A 2019-2020 Legislative Session

While that might be a little confusing, it really isn’t if you read the whole bill.

“This bill will leave to the department of health to determine the age at which children will be required to be vaccinated in light of ACIP recommendations.”

Senate Bill S298A 2019-2020 Legislative Session

After all, what are the ACIP recommendations?

“Routine vaccination at age 11 or 12 years has been recommended by the Advisory Committee on Immunization Practices (ACIP) since 2006 for females and since 2011 for males.”

Use of a 2-Dose Schedule for Human Papillomavirus Vaccination — Updated Recommendations of the Advisory Committee on Immunization Practices

Since there is nothing in the ACIP recommendations about kids in day care getting a dose of HPV vaccine, it should be very clear that S298A is not a mandate for day care, preschool, or kindergarten, etc.

It is a mandate for kids to get vaccinated and protected in middle school.

And New York, if this bill is enacted, would join Hawaii, Rhode Island, Virginia, and District of Columbia, which already have HPV vaccine school entry mandates.

More on HPV Vaccine School Entry Mandates

Has Gardasil Really Eliminated Cervical Cancer in Australia?

Why do some folks think that Gardasil hasn’t eliminated cervical cancer in Australia yet?

“New research from Cancer Council NSW, being presented this week at the International Papilloma Virus Conference (IPVC 2018) in Sydney and published in The Lancet Public Health, has shown that if vaccination and screening coverage are maintained at their current rates, cervical cancer is likely to be eliminated as a public health issue within 20 years.

The new research predicts that cervical cancer rates will drop to less than 6 in 100,000 by 2022 – meaning that it will soon be considered a rare cancer. Rates will continue to drop further, dropping below 4 in 100,000 by 2035. These findings indicate that Australia is on-track to be the first country in the world to eliminate cervical cancer by successfully implementing a combined approach to vaccination and screening.”

Australia set to eliminate cervical cancer by 2035

Maybe it is because Gardasil really hasn’t yet eliminated cervical cancer in Australia…

Has Gardasil Really Eliminated Cervical Cancer in Australia?

Wait, so why is anyone trying to say that something that hasn’t happened yet isn’t true?

Is Bobby Kennedy trying to get in the way of work to eliminate cervical cancer?
Who is Dr. Robert Reichert?

Perhaps “Dr. Reichert” just misspoke and did say that Australia had already eliminated cervical cancer instead of that they were on their way to eliminating cervical cancer

It is true, after all. Australia is really on their way to eliminating cervical cancer thanks to the HPV vaccine!

What about all of the slides and tables that Bobby Kennedy included with his post?

Does Slide 1 really show a terrifying increased risk of cervical cancer?

Anti-vax folks like to misrepresent the results of this study.
Anti-vax folks like to misrepresent the results of this study.

Of course not.

It actually shows how thoroughly vaccines are tested before they are approved!

In this case, they were evaluating “the potential of Gardasil to enhance cervical disease in subjects who had evidence of persistent infection with vaccine-relevant HPV types prior to vaccination.”

And although Bobby Kennedy is claiming that is what they found, the women in the Gardasil group (6.5%) were much more likely to have a Pap test with HSIL (high grade squamous intraepithelial lesion) as those in the placebo group (3.7%) at the start of the trial! That’s before they were vaccinated and that’s why they were more likely to have cervical cancer. Remember, the HPV vaccines prevent cervical cancer. They do not treat cervical cancer.

Bobby Kennedy left this out, but during these trials, when they looked at other subgroups, they “did not raise a concern about enhancement of cervical disease due to HPV.”

And Bobby Kennedy‘s other slides?

In Slide 2, just after telling you to look at the vaccine insert, he claims that “nearly half of all women have had prior exposure to HPV – with 38% being exposed before age 10.”

Is that in the vaccine insert?

Nope, it comes from a small study he found, Genital HPV in Children and Adolescents: Does Sexual Activity Make a Difference?, which says that “sexual activity was associated with increased risk for genital high-risk HPV infection.”

Most studies find that prepubertal girls are negative for HPV.
Most studies find that prepubertal girls are negative for HPV.

Surprisingly, the study did find that some girls somehow had exposure to HPV even though they were not sexually active and some, even while they were prepubertal.

“The finding of asymptomatic HPV DNA in children, and correlation with live virus, infectivity, or disease is unclear.”

Jayasinghe et al on Genital warts in children: what do they mean?

Again, Bobby Kennedy leaves out the fact that almost all other studies have found that prepubertal kids and those who are not sexually active are negative for HPV.

And Bobby Kennedy‘s other slides?

The UK doesn't have vaccine mandates and rates of stage II or worse cancers were lower than ever.
The UK doesn’t have vaccine mandates and rates of stage II or worse cancers were lower than ever.

Did rates of cervical cancer increase “in the vaccinated group (20-24)” just after the start of a school vaccination campaign?

“Screening from age 20 yrs, rather than from age 25 yrs, would not prevent any more cancers from spreading beyond the cervix (stage II or worse) by age 27 yrs. The substantial increase in stage I cervical cancers in 24 and 25 year old women, corresponds to changes whereby a high proportion of women are now screened for the first time between ages 24.5 and 25.5 yrs. Previously some of these early stage screen detected cancers would have been prevented by treatment of high-grade cervical intraepithelial neoplasia following earlier screening and a few would have been screen-detected later – at age 26 or 27 yrs. Others may be slow-growing cancers, some of which could be argued to be over-diagnosed.”

Castanon et al on Is the recent increase in cervical cancer in women aged 20–24 years in England a cause for concern?

It kind of did, but only in the lowest grades and because they changed the ages for when these women were screened!

“Reassuringly no increase in stage II or worse cancers was observed in women under age 27 yrs. In fact, numbers of stage II or worse cancers diagnosed at age 24.5–25.0 yrs in 2014 are lower than in any other year since 2007.”

Castanon et al on Is the recent increase in cervical cancer in women aged 20–24 years in England a cause for concern?

And that’s not all they found!

Wait, Bobby Kennedy doesn’t mention that rates of cervical cancer are getting lower since 2007…

“Amidst these changes HPV vaccination was introduced in 2008 for girls aged 12–13 with catch-up for those aged 14–18.”

Castanon et al on Is the recent increase in cervical cancer in women aged 20–24 years in England a cause for concern?

What else happened since 2007?

That’s right. That’s about when we started vaccinating girls with the HPV vaccine.

A vaccine that has been very well studied since to see it’s effects on cervical cancer, including a large meta-analysis of 65 studies in 14 countries.

“More than 10 years have elapsed since human papillomavirus (HPV) vaccination was implemented. We did a systematic review and meta-analysis of the population-level impact of vaccinating girls and women against human papillomavirus on HPV infections, anogenital wart diagnoses, and cervical intraepithelial neoplasia grade 2+ (CIN2+) to summarise the most recent evidence about the effectiveness of HPV vaccines in real-world settings and to quantify the impact of multiple age-cohort vaccination.”

Brisson et al on Population-level impact and herd effects following the introduction of human papillomavirus vaccination programmes: updated systematic review and meta-analysis.

What did they find?

They found “compelling evidence of the substantial impact of HPV vaccination programmes on HPV infections and CIN2+ among girls and women, and on anogenital warts diagnoses among girls, women, boys, and men.”

“In countries like the UK, Australia, and Canada there has been dramatic reduction in HPV related infections and diseases, while in countries with very low coverage there has been very little impact.”

Marc Brisson on HPV vaccine: high coverage could eradicate cervical cancer within decades, say researchers

HPV vaccines are safe and effective and they prevent cancer!

Why are some folks still trying to scare parents away from vaccinating and protecting their kids with these necessary vaccines?

More on Gardasil Eliminating Cervical Cancer in Australia

I’m Not Anti-Vaccine, I Just Don’t Believe in the HPV Vaccine

Believe it or not, there are some parents who get their kids each and every vaccine, but skip the one that protects them from cancer.

I’m Not Anti-Vaccine, I Just Don’t Believe in the HPV Vaccine

Why?

HPV Vaccine is Cancer Prevention.

That’s a good question.

And although they won’t have a good answer, some of their reasons include that:

  • the HPV vaccine is too new – even though Gardasil was first approved in 2006 and the first phase 1 and phase 2 trials began in 1997!
  • they don’t think it is necessary – even though about 4,200 women die of cervical cancer each year (that’s just in the United States), even in this age of routine pap tests
  • it might lead their kids to have early sex or unprotected sex – even though studies show it won’t
  • Michele Bachmann once said it caused mental retardation – even though she had no evidence to support her claim
  • the HPV vaccine is too controversial – any “controversy” about Gardasil and Cervarix is made up by anti-vaccine folks
  • HPV vaccines can cause POTS, ASIA, primary ovarian failure, venous blood clots, behavior problems, or multiple sclerosis, etc. – even though over and over, studies have found HPV vaccines to be safe and to not cause any of the other serious side effects or vaccine induced diseases you read about on the Internet that scare you away from vaccinating and protecting your kids
  • it is banned in Utah – even though that isn’t true
  • it doesn’t provide life-long protection – even though the protection has been found to be long-lasting, as long as we have been giving the vaccine so far
  • it is banned in Japan and France – even though HPV vaccines aren’t banned anywhere and are actually on the immunization schedule in at least 64 countries
  • Katie Couric once did a scary segment on HPV vaccines – well, she did but later apologized… after being called out for pushing anti-vaccine misinformation
  • an HPV vaccine researcher says it’s dangerous – no, the HPV vaccine researcher, Diane Harper, actually says it is a safe vaccine
  • HPV vaccines are just for girls – even though there are around 11,000 cases of HPV induced cancer in men each year, including anal cancer and cancers of the mouth/throat and penis
  • their kids are too young and can get it later, when they are older – even though protection is likely better when they get the vaccine when they are younger, and you don’t want to wait too long, when you increase the chance that they will have had sex and will already be exposed to HPV

So why aren’t you getting your kids vaccinated and protected… against cancer?

Need to do more research? Read the links below and then schedule your kids for their HPV vaccine.

More on HPV Vaccine Safety