Tag: lawsuit

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

Did the National Childhood Vaccine Injury Act of 1986 Cause the Immunization Schedule to Triple?

Why do some parents think that the National Childhood Vaccine Injury Act of 1986 caused the immunization schedule to triple?

The National Childhood Vaccine Injury Act did not cause the immunization schedule to triple.

The usual suspects…

Did the National Childhood Vaccine Injury Act of 1986 Cause the Immunization Schedule to Triple?

It is not just folks holding anti-vax propaganda signs though.

“In 1986, Congress—awash in Pharma money (the pharmaceutical industry is No. 1 for both political contributions and lobbying spending over the past 20 years)—enacted a law granting vaccine makers blanket immunity from liability for injuries caused by vaccines. If vaccines were as safe as many claim, would we need to give pharmaceutical companies immunity for the injuries they cause? The subsequent gold rush by pharmaceutical companies boosted the number of recommended inoculations from 12 shots of five vaccines in 1986 to 54 shots of 13 vaccines today. A billion-dollar sideline grew into the $50 billion vaccine industry behemoth.”

Robert F Kennedy, Jr on The Harlem vaccine forum

It is a common anti-vax talking point that the immunization schedule ballooned in 1986, with passage of the National Childhood Vaccine Injury Act.

It didn’t.

The National Childhood Vaccine Injury Act did not cause the immunization schedule to triple.

In fact, it is very easy to see that most new vaccines weren’t added to the immunization schedule until the late 1990s and after.

  • hepatitis B – 1981
  • Hib – 1985
  • hepatitis B vaccine (improved) – 1986
  • Hib (improved) – 1988
  • Varivax – 1995
  • DTaP – 1996 (replaces DTP)
  • hepatitis A vaccine – 1996
  • RotaShield – 1998 (quickly withdrawn)
  • LYMErix – 1998 (later withdrawn)
  • Prevnar – 2000
  • FluMist – 2004
  • Menactra – 2005 (replaces the Menomune vaccine approved in 1981)
  • Tdap – 2006
  • RotaTeq – 2006
  • Gardasil – 2006
  • Trumenba – 2014

And the immunization schedule did not change very much at all after passage of the National Childhood Vaccine Injury Act.

What about Bobby Kennedy‘s other point? Why did we need the National Childhood Vaccine Injury Act if vaccines are safe?

Protection from frivolous lawsuits.

What we need now is protection from this kind of misinformation that continues to scare parents away from vaccinating and protecting their kids!

More on the Immunization Schedule

About That Amish Vaccine Exemption Lawsuit in New York

An Amish family has filed a lawsuit against a new vaccine law in New York that eliminated religious vaccine exemptions.

An Amish family has filed a lawsuit against a new vaccine law in New York that eliminated religious vaccine exemptions.

Folks who know that Amish do indeed vaccinate their kids are likely surprised by the lawsuit…

About That Amish Vaccine Exemption Lawsuit in New York

Wait, what?

The Amish vaccinate their kids?

While many Amish don’t vaccinate according to the recommended CDC schedule and get all vaccines, many do get at least some of them.

For example, when a large measles outbreak went through Amish communities in Ohio, many got in line to get vaccinated and stop the outbreak, which ended up getting at least 383 people sick.

That wasn’t the only outbreak among the Amish though.

Remember the last cases of wild polio in the United States?

“The 1979 outbreak occurred in unvaccinated Amish persons living in Iowa, Missouri, Pennsylvania, and Wisconsin. Overall, 15 cases of illness caused by wild poliovirus type 1 occurred among U.S. citizens: all 10 paralytic cases occurred among unvaccinated Amish persons; three cases of transient paralysis occurred among unvaccinated Amish persons; and two nonparalytic cases occurred among unvaccinated members of the Mennonite church who were in frequent contact with Amish persons. Epidemiologic and virologic evidence indicated this outbreak resulted from importation of poliovirus from the Netherlands through Canada (Ontario), where outbreaks had occurred during 1978 in members of religious groups with objections to vaccination.”

Poliomyelitis — United States, Canada

It was in 1979.

It was among the Amish.

And many Amish got vaccinated to help eliminate the endemic spread of polio in the United States.

“Immunization campaigns for the Amish are continuing; at least half of the nation’s Amish have now received 1 or more doses of oral poliovirus vaccine.”

Poliomyelitis — United States, Canada

So the Amish are clearly not against vaccines.

In 2004, there was an outbreak of pertussis (345 cases) in an Amish community in Kent County, Delaware.

“Of the 96 households interviewed in which a pertussis case was discovered, a total of 43 (45%) reported not vaccinating any children in their household, 40 (42%) households reported vaccinating at least some children, and 13 (14%) did not provide this information. Of the 43 households not vaccinating children, 19 cited “fear of side effects” as the reason, 13 reported that they “didn’t think about it,” and 11 did not provide specific reasons for nonvaccination. Of the 40 respondents who reported that their children had received vaccinations, 29 (64%) reported vaccination at vaccine clinics set up at Amish homes by DPH nurses.”

Pertussis Outbreak in an Amish Community — Kent County, Delaware, September 2004–February 2005

Although many of the kids weren’t vaccinated, religion didn’t seem to be what drove that decision.

“Religious factors and access to care were not among reasons most reported. “

Kettunen et al on Evaluation of low immunization coverage among the Amish population in rural Ohio.

It is usually fear, rather than religion that keeps the Amish from vaccinating and protecting their kids.

“The findings from the data analysis demonstrated that fear, especially concern over too many recommended immunizations and immunizations overwhelming the child’s system, was the most frequent reported reasons for not having children immunized according to recommendations.”

Kettunen et al on Evaluation of low immunization coverage among the Amish population in rural Ohio.

Unfortunately, this has meant that their children get a high rate of vaccine preventable diseases and that they end up getting hospitalized at higher rates than other children.

“The outcome of pregnancy was determined for the 94 Amish mothers who reported illness or had serologic evidence of maternal rubella (Table 1). CRS occurred in 10 infants, all of whom were born to mothers who had histories of rubella-like illness in the first trimester; seven had possible manifestations of CRS; nine were miscarried/stillborn; and 68 infants appeared normal at birth. During the study period, medical personnel identified one additional infant with CRS from Lancaster County whose mother was a conservative Mennonite. “

Congenital Rubella Syndrome Among the Amish — Pennsylvania, 1991-1992

So not only do the Amish get sick, they get sick for the same reason as typical anti-vaxxers – misinformation and fear of vaccines.

Is that what’s driving this lawsuit in New York?

I don’t know, but if it was just about religion, why does it include typical anti-vaccine talking points about:

  • fetal DNA contaminating our vaccines
  • that unvaccinated children were not responsible for the 2018-19 NYS measles outbreak, going so far as to cite an affidavit from Lawrence Palevsky, who said that “a measles infection in first world countries such as the United States, in 2019, is not deadly.”
  • how the 2018-19 NYS measles outbreak might not have been “true wild-type measles infections.”
  • that the theory of herd immunity is flawed
  • that vaccinated children pose more of a risk to other vaccinated children than the unvaccinated

More than anything though, how can the lawsuit say that New York’s vaccine law unreasonably burdens his “sincere religious beliefs without a compelling state interest,” when we know that the Amish aren’t really against vaccinating and protecting their kids?

You have to wonder what method his lawyer’s used to pick their “examples” of schools with religious exemptions.

About that compelling state interest…

As many parents have come to abuse religious exemptions, using them as personal belief exemptions, we have ended up in a situation in which over 30 schools in New York had religious exemptions rates of at least 50%, including 14 schools in which each and every student had a religious exemption for all vaccines.

All that even though no major religion is against vaccines!

With such a weak case, forum shopping might be his only strategy that could work…
With such a weak case, forum shopping might be his only strategy that could work…

What happens next?

More court stuff, but in the end, it hopefully means that more kids will be vaccinated and protected and we will #StopTheOutbreaks.

More on the Amish and Vaccines

Has Bobby Kennedy Taken Over the Anti-Vaccine Movement?

What happened after SB276, the new vaccine law, was signed in California?

Did Bobby Kennedy's "mic dropping speech" mark the birth of a new civil rights movement for the health freedom or anti-vaccine movement?
Did RFK Jr’s “Mic Dropping Speech” Mark the Birth of a New Civil Rights Movement for the Health Freedom or Anti-Vaccine Movement?

They flew Bobby Kennedy back to Sacramento for a rally.

Has Bobby Kennedy Taken Over the Anti-Vaccine Movement?

What did he have to say?

“It’s a sad day for California. And it’s a sad day for our country. And I have asked a question and I would like to ask this legislature who voted for this God awful bill. If we can give government and big industries the right to inject untested medical products that are zero liability into our children coercively, where does the power of government end? What else can they order us to do? Can they do the same thing that they do in China? Which is to tell people that they have to abort their babies for “the good of society?” Can they euthanize people for “the good of society?” Where is the legal boundary?

Bobby Kennedy

It is a sad day when a Kennedy is spouting this kind of stuff…

Vaccines are well tested and everyone has a choice on whether or not to get vaccinated. Mandates to attend school do not force parents to vaccinate their kid.

Comparing these mandates that protect those who can’t be vaccinated to forced abortion and euthanasia is unconscionable.

“We have signed treaty after treaty after treaty saying you can not force an American citizen or any citizen of the civilized world to take a medication or to submit themselves to a medical procedure without informed consent. What has happened to the Democratic party? What has happened to the party that used to stand for listening to women? Why are they listening to pharmaceutical companies and not to the women?

Bobby Kennedy

What has happened to the Kennedys?

Again, vaccine mandates do not force anyone to get vaccinated and protected.

And pushing anti-vaccine talking points on folks is not giving them informed consent. This type of misinformation simply scares them away from vaccinating their kids. It is misinformed consent!

“And yet, you have all of the members who voted for this and none of them can answer the question – where is all of the autoimmune diseases coming from? If it’s not the vaccines, then where is it coming from? We have, from my generation, according to HHS, 12% of the people in my generation, prior to 1986, had chronic diseases. Today, 54% did. Let’s pretend all of those hundreds and hundreds of studies aren’t there that say it’s the vaccines.”

Bobby Kennedy

Let’s pretend that his statistic that 54% of American children have a chronic illness…

Actually, let’s not, because it isn’t true. Although often cited by anti-vaccine folks, the number comes from a 2011 report, A national and state profile of leading health problems and health care quality for US children: key insurance disparities and across-state variations, but doesn’t mean what most people think it means.

“An estimated 43% of US children (32 million) currently have at least 1 of 20 chronic health conditions assessed, increasing to 54.1% when overweight, obesity, or being at risk for developmental delays are included; 19.2% (14.2 million) have conditions resulting in a special health care need, a 1.6 point increase since 2003.”

Bethell et al on A national and state profile of leading health problems and health care quality for US children: key insurance disparities and across-state variations.

Is obesity a vaccine injury?

Where are the “hundreds and hundreds of studies… that say it’s the vaccines?”

“Let’s pretend that all the vaccines, everyone of those diseases, the autoimmune diseases – Guillain-Barré syndrome , cerebral palsy, diabetes, Rheumatoid arthritis. The neurodevelopmental diseases, ADD, ADHD, speech delay, language delay, tics, Tourette syndrome, ASD, autism. The allergic diseases – allergies, food allergies, eczema, asthma, anaphylaxis. Where can we find those listed? In two places. One in the list of chronic diseases that are now epidemic among American children and on the vaccine inserts. And why would the company put them on the vaccine insert? They put them there because the only way you can sue them under NCVIA is if they know or suspect of an injury being caused by a product and they failed to put it on the insert. So it’s the one place where their honest. For many years they told us, well, just because we put it on the insert, it doesn’t mean that it is actually a vaccine adverse event or caused by the vaccine. But the code of Federal regulations says you can not put it on an insert unless you believe that it’s caused by the vaccine. So they are lying.”

Bobby Kennedy

Well, someone is lying…

Although listed in the vaccine insert, if they are in the Adverse Reactions section, they may not actually be caused by the vaccine.
Although listed in the vaccine insert, if they are in the Adverse Reactions section, they may not actually be caused by the vaccine.

What goes into a vaccine insert is dictated by the FDA, specifically the Code of Federal Regulations Title 21, and Section 314 of the NCVIA, after consultation with the Advisory Commission on Childhood Vaccines, including:

  • Contraindications – all situations when the vaccine should not be given
  • Warning and Precautions – all adverse reactions and safety hazards that may occur after getting the vaccine and what you should do if they occur
  • Adverse Reactions – this section includes clinical trials experience, post-marketing experience, and voluntary reports, and it is very important to understand that it is not always possible to establish a causal relationship to vaccination for these adverse effects. So just because something is listed here, whether it is SIDS, autism, drowning, or a car accident, doesn’t mean that it was actually caused by the vaccine. Updated in 2006 to require that only adverse events “for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event,” it still doesn’t mean the adverse event was definitely caused by the vaccine.

As a lawyer, you would expect, or at least hope, that Bobby Kennedy understands how vaccine inserts really work…

“This state is doing something horrendous. It is stepping between a doctor and the 4000 children in this state whose doctors have told them you can not afford to get a vaccine because it could kill you or it could cripple you. Their doctor, who has known that child often-times since birth, who has reviewed the medical records, who has done all of the tests on that baby, who knows the family, has said it is dangerous to receive this product. Don’t ever do it. And yet, the State of California, is going to come in, a bureaucrat, between that doctor and that child, and say that we are going to give it to him anyway. This is criminal.”

Bobby Kennedy

This is probably one of the biggest myths about California’s new vaccine law.

For one thing, SB276 doesn’t revoke legitimate medical exemptions.

Did Ron Kennedy know these kids since birth and think that vaccines would kill or cripple them because they had a learning disability or food allergies?
Did Ron Kennedy know these kids since birth and think that vaccines would kill or cripple them because they had a learning disability or food allergies?

And the problem hasn’t typically been the legitimate medical exemptions from doctors who have known kids since birth, but rather inappropriate exemptions from doctors who advertised medical exemption consultations and appointments for new patients.

“Big pharmaceutical companies are the most evil companies on earth. Who are commoditizing our children. Who are giving our children this tsunami of chronic disease and then making the money to try and tell us that we are going to get rid of infectious disease, like chickenpox and measles, but we are going to trade that for rheumatoid arthritis and diabetes and autism and ADD and ADHD. And all of those infectious diseases are treatable and curable, usually within a week, and none of the chronic diseases that they are causing are treatable or curable. And they are making $50 billion dollars selling our kids these mandated vaccines that are untested and liability free, but they are making $500 billion a year selling them the epi-pens, the seizure medications, the Prozac, the albuterol inhalers, the rhumatoid arthritis medication, the diabetes medications that our children are now addicted to for life because of these vaccines. ”

Bobby Kennedy

As usual, it all comes back to Big Pharma conspiracy theories and the idea that everything is a vaccine injury.

Bobby Kennedy thinks the pharmaceutical industry is in "a war against our children."
Bobby Kennedy thinks the pharmaceutical industry is in “a war against our children.” Do you?

So what’s their next plan?

Lawsuits.

Lawsuits so that they can help keep kids unvaccinated and unprotected.

“We are an insurgency. They can not stop us now. We are not going to go away.”

Bobby Kennedy

Of course the anti-vaccine movement is not going away. It has been around since before we had the first real vaccine, when folks were getting variolated to protect them against smallpox.

“You know this is the most important battle, probably in human history.”

Bobby Kennedy

Fighting to keep your intentionally unvaccinated kids in school, where they could put others at risk to get sick, including kids with immune system problems or those being treated for cancer, is the most important battle in human history?

He wasn’t done yet though…

“What we have to understand is that the domination of business by government is called communism. The domination of government by business is called facism. And what we’re fighting for is the essential tenets of American democracy, which is free market capitalism, which we don’t have. They destroyed the markets didn’t they. There’s no market for vaccines because they couldn’t sell them, so they had to disable the markets and force us to take them against our will. And for democracy and they’ve taken democracy from us. And they’ve taken the institution of Justice directly. They have gotten rid of the 6th and 7th amendment guarantees. The Federal Constitution guarantees of a jury trials. We are the only people in our country who you can injure – a private corporation can injure and disable and you can’t get a jury trial.”

Bobby Kennedy

Except that you can’t usually get a jury trial if you think you have a vaccine injury. The only thing is that you have to go through the Vaccine Court first.

Be skeptical if you truly want to learn to protect your kids. Although speeches from folks like Bobby Kennedy might make you feel better about your decision to skip or delay your child’s vaccines, understand that it is not really an informed decision.

More on Bobby Kennedy