Tag: ethics

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

Why Did Germany Make the MMR Vaccine Mandatory?

Have you seen the news about the new law that called for mandatory measles vaccination in Germany?

A new law that calls for mandatory measles vaccination in Germany.
Maybe we just need laws against this kind of misinformation about vaccines and vaccine-preventable diseases…

It’s true, although it certainly won’t cause “death and injury rates” to sky rocket.

Why Did Germany Make the MMR Vaccine Mandatory?

So why did it happen?

“Often, there is a lack of information or targeted disinformation that prevents people from getting themselves or their children vaccinated and exposure to avoidable health hazards.”

Opinion of the Scientific Advisory Board of the Paul Ehrlich Institute, Federal Institute for Vaccines and Biomedical Drugs, On the Quality and Safety of Vaccines

Germany has been one of the countries most affected by measles outbreaks in Europe over the past few years, with over 5,000 cases since 2015.

And at least three measles deaths, including an unvaccinated toddler. Plus additional deaths from SSPE.

This toddler in Germany who died in 2015 was not vaccinated for measles.
This toddler in Germany who died in 2015 was not vaccinated for measles.

And almost all of the cases are among those who are unvaccinated.

This led to the reestablishment of endemic measles virus transmission in Germany in 2017, even as we are supposed to be working towards eliminating measles.

So what does mandatory measles vaccination in Germany mean?

“The bill stipulates that all children from the age of one on entering the school or kindergarten must have the measles vaccine recommended by the Standing Vaccination Commission. In the case of care by a childminder, proof of measles vaccination usually has to be provided.

The same applies to persons who work in community facilities or medical facilities such as educators, teachers, day care workers and medical staff (if these were born after 1970). Asylum seekers and refugees must also have the vaccine protection four weeks after admission to a shared accommodation.”

Vaccination is designed to protect children from measles

Passage of the Measles Protection Act (Masernschutzgesetz), which goes into effect on March 1, 2020, also means that parents can be fined up to €2,500 if they don’t vaccinate their children, daycare centers can be fined for admitting unvaccinated children, and certain unvaccinated workers, including healthcare workers, can be fined.

“Since measles vaccination is highly effective and very well tolerated, the German Ethics Council is of the opinion that every person is morally obliged to have him- or herself vaccinated against measles and, if applicable, to provide appropriate immunisation for his or her own children.”

Ethics Council: Increasing measles vaccination rate by a package of measures rather than by mandatory vaccination

While some oppose the law, including the German Ethics Council, it is important to note that few people see mandatory vaccination as the first step in getting folks vaccinated and protected. It is typically one of the last measures taken after everything else has failed and outbreaks are once again getting out of control, with people dying needlessly of an easily preventable disease.

Don’t want vaccine mandates to come to your community?

Then stop scaring people away from getting vaccinated and protected with misinformation and propaganda!

Vaccines are safe, with few risks, and are obviously necessary.

More on Mandatory Measles Vaccination in Germany

Getting Vaccinated to Protect Those Who Can’t Get the Vaccines

Most people get vaccinated because those vaccines have the direct benefit of reducing their risk of getting a life-threatening vaccine preventable disease. Protecting those who can’t get vaccines is a secondary benefit.

Should you get vaccinated to protect those who can't get the vaccines?
Does rationalizing your decision in anti-vax Facebook groups help you feel better that you are putting kids with cancer at greater risk to get sick?

A secondary benefit that anti-vax folks go to great lengths to convince themselves isn’t real and justify their decision to leave their kids unvaccinated and unprotected..

Getting Vaccinated to Protect Those Who Can’t Get the Vaccines

Of course, none of their explanations really hold water.

None of the vaccines that are routinely used on the CDC immunization schedule are a risk if you are around kids with cancer or other immunodeficiencies, except for FluMist and those with severe issues, like being in a bone marrow transplant unit.

One of the biggest misconceptions though, is that in getting vaccinated, parents are putting their own kids at great risk to protect someone else.

Don't set your kid on fire to keep mine warm!
Don’t set your kid on fire to keep mine warm!

Of course, that’s not true.

Remember, vaccines are safe, with few risks.

That why the analogy of setting their own kids on fire to keep others warm doesn’t make any sense.

After all, unlike vaccinating their own child, setting their child on fire offers them no benefit!

And they should understand that the one and only reason that their kids don’t get more vaccine-preventable diseases in this dog eat dog world is because the vast majority of us vaccinate and protect our kids.

Herd immunity is indeed real. In addition to protecting those who can’t be vaccinated, it protects the free-riders, those who just don’t want to get vaccinated.

What about the idea that it is unrealistic for folks who are immunocompromised to expect that they can lead normal lives and avoid infections?

You can't avoid all risks of infection, but why not avoid those that you can?

While it is true that there are other infections out there besides those that are vaccine-preventable, wouldn’t you want to at least reduce those risks that you can?

But could it be, as much as they seem to believe in shedding, that they think they are being altruistic in not vaccinating their kids?

Anti-vax folks are all about the shedding...
Anti-vax folks are all about the shedding…

They aren’t.

In most cases, there are no restrictions on vaccinating people who have contact with those with immune system problems.

What about the idea that vaccines cause cancer?

Vaccines prevent cancer!
Vaccines prevent cancer!

That isn’t true. In fact, there are several vaccines that prevent cancer!

What other misconceptions do they have?

Most of the reasons folks use to avoid vaccines have been refuted a thousand times.
Most of the reasons folks use to avoid vaccines have been refuted a thousand times.

Let’s look at those last few issues…

  • vaccines are not associated with autism
  • vaccines aren’t perfect, but they do work very well
  • vaccines do help those with immune system problems, sometimes directly and more often because of herd immunity
  • people who have cancer are often vaccinated before they have chemo, but that protection gets wiped out during treatment and they can’t get caught up until after they have completed all of their treatments
  • kids with cancer might get some vaccines, but typically don’t get live vaccines

What about the idea that your unvaccinated child isn’t sick, so can’t get anyone else sick?

While that is a very common argument among anti-vax parents, it is very important that if your child is unvaccinated, then they are at much greater risk to catch a vaccine-preventable disease. And since you are often contagious even before you show symptoms, they might unknowingly expose many other people before they even realize that they are sick.

Hopefully you now understand it was never really a question.

That's why you get vaccinated, to protect those who can't get the vaccines!

Vaccinate and protect your kids.

If you don’t, in addition to putting them at risk to get sick, you put everyone around them at risk, including some who are at very high risk for severe complications from vaccine preventable diseases.

More on Risks from Unvaccinated Kids

Reactions to SB 276 Passing the Assembly

On the same day that the LA Times wrote what some are calling a false balance about Bob Sears, SB 276 passed the California Assembly and Gavin Newsom called for the addition of amendments that would protect doctors who have been writing an excessive amount of medical exemptions.

Gavin Newsom's proposed amendments could weaken SB276.
Exempting individual medical information on exemptions from the Public Records Act is not a bad idea.

Coincidence?

Reactions to SB 276 Passing the Assembly

As the amendments only serve to weaken SB276, Governor Newsom should consider backing off on his request to change the bill, especially as he had previously said he would support it.

Protecting kids from vaccine preventable diseases is unethical and evil???
Protecting kids from vaccine preventable diseases is unethical and evil???

While the amendments will protect those who have been writing inappropriate medical exemptions, they won’t appease most people who are against SB 276.

Who is talking about forcibly injecting people with vaccines? Remember, mandates don't force anyone to get vaccinated and protected...
Who is talking about forcibly injecting people with vaccines? Remember, mandates don’t force anyone to get vaccinated and protected…

Especially as most of those folks still don’t understand exactly what SB276 does!

SB 276 does not eliminate all medical exemptions.
SB 276 does not eliminate all medical exemptions.

What silent loophole are these folks talking about?

The nephew of California State Assemblymember Lorena Gonzalez is immunocompromised.

“His doctor said no, he can’t have live vaccines, so no, he can’t be immunized against measles or chicken pox. Every time he is not in the hospital, he wants to be in school, but those diseases could kill him. Definitely put him back in the hospital. These are the children, the truly medically fragile children that we are trying to prevent from getting these diseases and why it’s so important.”

California State Assemblymember Lorena Gonzalez Assembly Floor Session, Tuesday, September 3rd, 2019

He has a medical exemption to getting vaccinated.

Unless the medical exemption is to all vaccines and not just live vaccines, he won’t lose his exemption and won’t need a “silent loophole.”

Having a “known severe immunodeficiency” is a well known contraindication to getting live vaccines, including MMR and the chickenpox vaccine.

Not only would his exemption be allowed, it not be one of only 5 exemptions that his doctor is allowed to make!
Not only would his exemption be allowed, it would not be one of only 5 exemptions that his doctor is allowed to make!

SB276 also doesn’t limit the number of medical exemptions that doctors can write. It just states that if a doctor writes 5 or more exemptions in a calendar year, then those exemptions will be reviewed by a medical panel to make sure that they are legitimate.

Why do 5 exemptions trigger a review? Because the average doctor will likely not need to write that many medical exemptions, as there are very few true medical reasons to avoid or skip vaccines. What if a doctor writes 10 or 15 legitimate medical exemptions? If they are reviewed and found to be legitimate, then 10 or 15 of their patients will have medical exemptions!

How will they revolt - because they don't want to vaccinate and protect their kids?
How will they revolt – because they don’t want to vaccinate and protect their kids?

Are Newsom’s amendments going to stop folks who are talking about revolutions?

Wait, which amendment is she talking about???

Is it going to protect kids from those who might continue to get unnecessary, permanent exemptions until the protections of SB 276 finally do take effect?

More on SB276