Wednesday, 8 April 2015

(Un)Informed Consent: A Few Things Parents Don’t Know About the Measles, Mumps & Rubella Vaccine


(Un)Informed Consent:

A Few Things Parents Don’t Know About the Measles, Mumps & Rubella Vaccine

 


uninformedpart1
 
 by Louise Kuo Habakus


I’ve been dismayed by the national brouhaha characterized by the Four “Astroturf” Horsemen of Vaccine Hysteria: Fear, Anger, Blame, Hatred.

  • The unvaccinated must be hunted down and punished
  • Measles is deadly
  • We need a federal mandate for the measles vaccine
  • No exemptions for anyone

There’s nary a mainstream outlet that hasn’t jumped in and piled on. For a group of investigative journalists, health reporters, seasoned writers, and popular bloggers that claims to wrap themselves in the cloak of modern science, there’s precious little scientific or even analytic thinking, let alone responsible, measured discussion. It remains to be seen whether mainstream journalism will grow a spine.

In the meantime, however, what concerns me is how little parents know about the combination measles, mumps & rubella vaccine (MMR).

I worry about informed consent.

In this post we address the safety of the vaccine itself [and] what’s going on with its manufacturer, Merck & Co.

 

MMR Vaccine Safety

Documentation of adverse events following vaccination

 

Start with the basics:



Measles can travel via neurons to your brain

Measles virus can present as three different forms of infection in the central nervous system.

We’ve known that measles virus can travel via neuronal spread and enter the brain. It’s called “axonal transport” and it’s as fast as it sounds.

What is not commonly understood, however, is that it’s not just the natural contraction of disease that’s implicated. Vaccination can carry measles virus to your brain, too. From a study in the peer-reviewed Current Topics in Microbiology and Immunology:

[A]ttenuated vaccine strain can traffic to the brain under conditions of poor immune surveillance.

Injection of MMR vaccine can cause the live measles virus to hop a neurological bullet train to your brain. 

The Merck Manual acknowledges that vaccines can cause brain damage:

Encephalitis is inflammation of the brain that occurs when a virus directly infects the brain or when a virus, vaccine, or something else triggers inflammation. The spinal cord may also be involved, resulting in a disorder called encephalomyelitis.

The problem is that we don’t know as much as we should, given the way we vaccinate children today. This 2012 peer-reviewed summary in the journal Progress on Health Sciences makes a similar point about the neurologic adverse events following vaccination:

In this study, the measles viruses were researched, but under the immunization program children also receive vaccinations with simultaneous administration of several viral components. What then occurs in the brain of a child? Presently, there are no studies in this area.


Old science?

When it comes to informed consent on the MMR vaccine, the package insert is a good place to start.

A colleague of mine calculated the average publication date of every piece of science in the package insert and came up with… 1982. We’re talking roughly 33 years ago — with some studies much older than that. Does it make you wonder…

How much of today’s vaccine policy is based on yesterday’s science?

Who’s responsible for updating it? Making a case for R&D?

If large numbers of parents are doing this research on their own and calling for more vaccine safety studies, doesn’t this make them pro-science?

Who, then, are the anti-science denialists?


Science from one month ago

This new study, “Safety of Measles-Containing Vaccines in 1-Year-Old Children,” was quietly published online on January 5, 2015 by Pediatrics, the journal of the American Academy of Pediatrics. Here’s the abstract and the full study.

The article compares the administration of MMRV (“ProQuad”) versus MMR + Varicella (“Varivax”) separately. The authors confirm that there are more febrile seizures in children who get MMRV as a single shot than those who get MMR + V separately but on the same day.

This is significant.

The separation of the shots is not the only variable. In fact, the separation of the shots may not be much of a variable at all since both groups are getting all four vaccine infections simultaneously. It shouldn’t matter where on the body you inject the vaccine viruses since all four vaccine virus strains produce systemic, whole body infections, right?

So why is there a difference in health outcomes (i.e., seizures and possibly other sequelae)?

The vaccines are not the same.

MMRV contains nearly 10 times more varicella potency than MMR + V (this is available in the package inserts). The MMRV group is getting a much higher dose. It’s the total dose of the vaccine that causes the problem. If MMR + V is safer than MMRV, then that argues that M + M + R is safer than MMR.

Keep reading to find out why combination vaccines require greater viral potency.


Measles vaccine cultured on human tissue

The two versions of the vaccine available in the U.S. are MMR-II and MMRV. Both contain WI-38 human diploid lung fibroblasts. This is significant for several reasons:

First, these cells are cultured on fetal tissue derived from terminated pregnancies (abortions). For some parents, abortion violates their religious beliefs or principles. Parents who oppose abortion and do not want these and other vaccines cultured on human diploid cells should have the right to decline these vaccines for themselves and their children.

Second, injection of human biologics always carries with it the risk of both known and unexpected (“adventitious”) agents, including the possibility of viral contamination (i.e., SV40 in the polio vaccine), ERV infection (endogenous retroviruses), and DNA insertion into the host genome.


Buy one, get two free – the history

If measles vaccine is so important, why isn’t the monovalent measles vaccine available? A monovalent vaccine contains antigens from a single strain of a microorganism. Why do our children have to get vaccine targeted against three different diseases at the same time?

MERCK STOPPED MAKING IT…

 

On Christmas Eve 2008, Merck quietly announced on the American Academy of Family Physicians site that it would no longer make separate “monovalent” measles, mumps, and rubella vaccines and would instead be focusing on their combination MMR. shot. This article, which is no longer available on the AAFP, Merck, or any other “establishment” site, read as follows:

Merck & Co. Inc. has stopped production and sales of its monovalent vaccines for measles, mumps and rubella. The manufacturer instead plans to focus on its combination vaccine, MMRII.

Merck spokeswoman Amy Rose said MMRII accounts for 98% of the company’s volume for measles, mumps and rubella vaccines…

“The combination vaccine is what’s recommended, and it’s such a significant portion of the orders we see,” said Rose. “It’s in the best interest of public health to make more of that rather than dedicate manufacturing capacity to monovalents.”

Rose said Merck had not decided when, or if, it might make the monovalent vaccines available for sale in the future.

… THEN THEY FLIP-FLOPPED

 

Merck received a deluge of complaints from concerned parents. The company responded that it would make them again. This commitment was also documented in this Merck Vaccines Supply Status from 7.20.09 (read the footnote).

This intention was not long-lived. Perhaps Merck had just been testing the waters and determined there would be no lasting brand damage? The pharma giant quietly reneged in October 2009 with this statement:

Based on input from the Advisory Committee on Immunization Practices (ACIP), professional societies, scientific leaders, and customers, Merck has decided not to resume production of ATTENUVAX® … MUMPSVAX® … and MERUVAX® II. This science-based decision will support vaccination of the largest group of appropriate individuals. Merck will continue to focus necessary resources to ensure that they can help meet current and future global public health needs…  [emphasis mine]

It is interesting that they chose to describe their decision as “science-based” and their focus expands far beyond our country’s borders.

Merck hasn’t spoken on the matter since. I never saw any public discussion about the merits of this decision. Nearly all press related to this significant public health announcement has been removed from the internet.

 

“NO HARM IN GETTING ALL THREE”

 

The AAFP tried a bit of clumsy damage control:

Doug Campos-Outcalt, MD, MPA., who serves as the AAFP’s liaison to the CDC’s Advisory Committee on Immunization Practices… said Merck’s decision was insignificant in terms of public health… [but] some parents likely will be unhappy.

“The use of the single antigen is pretty limited,” he said. “There’s no harm if you need one in getting all three. There are some parents out there that want a delayed vaccine schedule. They want the vaccines spread out over a longer period of time and not so many at once. That’s a lot of hooey. Alternative schedules have never been proven to be superior.”

I’d like to see the scientific support for Campos-Outcalt’s statement. Combination vaccines are associated with the lion’s share of vaccine injury compensation claims. Scientists acknowledge that combination vaccines have greater “reactogenicity” [Katkocin & Hsieh, p. 57]. Reactogencity is the property of a vaccine to produce common, expected adverse reactions (i.e., injury and death).

 

PARENTS SPEAK UP

 

Parents wanted the individual vaccines very badly. Some were in the process of separating the vaccines. I was contacted by dozens who were frantically calling pharmacies and children’s hospitals across the country trying to locate the last few remaining doses. I know of parents who traveled overseas with their children to obtain the individual measles vaccine.

Although the monovalents are unlicensed in Britain, private clinics that offer the single vaccines do a brisk business, and parents are willing to pay out of pocket. The “Single measles jab” article in the Daily Mail says it’s not illegal to import the vaccines and names private practice doctors who can help.


Demand & Supply

I am not arguing for measles vaccination with the monovalent vaccine. This serious, private medical decision is for parents to make.

But let’s examine the logic for a moment. There are some parents who choose not to vaccinate their children with MMR or MMRV who might opt to vaccinate their children against measles if the monovalent measles vaccine were available:



  • Maybe their child already has positive titers for mumps and/or rubella.

If the stated public health goal is to prevent measles outbreaks, and vaccination is the proposed solution, why not offer the measles vaccine in all forms that parents are willing to accept?

I offer three possible reasons:

#1: PROFITABILITY

 

Combination vaccines are more profitable.

Exclusive reliance on combination shots results in more vaccines purchased and administered. Let’s use New Jersey’s “Minimum Immunization Requirements for School Attendance” to illustrate the point. Children born after 1/1/90 need 1 dose of mumps vaccine, 1 dose of rubella vaccine, and 2 doses of measles vaccine. Since it’s not possible to get the measles vaccine separately, children must receive 2 doses of each to meet NJ’s mandate for day care and school admission.

#2: INCONVENIENT QUESTIONS

 

Availability of both individual vaccines and the combination vaccine might prompt parents and clinicians to scrutinize differences and ask Merck some difficult questions:

Q: Why is there so much more scientific literature on the safety of the individual measles vaccine and very little on the combination MMR vaccine?

Q: Are you concerned about immunological interference between components of a combination vaccine?

I found this statement by a Merck scientist about the challenges of making MMRV:

“Numerous studies have shown that when a monovalent dose of varicella vaccine is added to an MMR vaccine the titer of antibody against varicella is reduced by about one-half.  This is believed to be due to immunological interference by the measles vaccine.”

Q: Can you explain this statement in the Merck’s package insert for MMR about multiple simultaneous vaccination?

“Routine administration of DTP (diphtheria, tetanus, pertussis) and/or OPV (oral poliovirus vaccine) concurrently with measles, mumps and rubella vaccines is not recommended because there are limited data relating to the simultaneous administration of these antigens.” [page 9]

#3: WHO’S IN CONTROL?

 

The availability of individual vaccines gives parents and clinicians greater flexibility and control over vaccine selection and timing. If sufficiently large numbers of children are vaccinated using different vaccines and schedules, it could give rise to disconcerting variations in health outcomes. Requiring all children to receive the combination vaccine takes this potential scenario off the table.

***


Hundreds of millions of children have received Merck vaccines. The combination MMR is its flagship vaccine: profitable and prevalent, with exceptionally consistent and high compliance. Public confidence in vaccines is based upon trust. Parents should know that Merck has every interest in serving up a very simple narrative about vaccine safety and individual choice. It doesn’t mean that all parents will choose not to vaccinate. It does mean that they have to work hard to get the information they deserve.


What’s Going on with Merck & Co?

Who’s Merck & Co?

Merck & Co. is a U.S. corporation headquartered in New Jersey and the world’s seventh largest pharmaceutical firm. It was founded in 1891 as the U.S. subsidiary of a German company by the same name. The U.S. confiscated the subsidiary after World War I and established it as an independent company.

In 2014, Merck & Co. reported $42.4 billion in worldwide revenues and $10.3 billion in net income. It ranked #65 on the Fortune 500. Merck Vaccines is a $10.1 billion business. A little over half its sales comes from the following childhood vaccines:

  • $1,738,000,000  Gardasil (HPV)

  • $1,394,000,000  MMR/ProQuad/Varivax (measles, mumps, rubella, chickenpox)

  • $   765,000,000  Zostavax (shingles)

  • $   746,000,000  Pneumovax 23 (pneumococcal)

  • $   659,000,000  RotaTeq (rotavirus)

The company also makes childhood vaccines for Hepatitis A, Hepatitis B, and Haemophilus influenzae B (Hib).

For Merck, the tsunami of pro-measles vaccine press has been a welcome distraction from some bad news. I’d like to share a few of the big stories that have not gotten the media play they (and we) deserve.


“Investors should avoid this stock”


$42.4 billion sounds pretty good to most of us and Merck’s top brass are well fed — executive compensation is publicly disclosed — but shareholders are unhappy and analysts are not sanguine.

TheStreet.com reported on 2/4/15 “Merck’s Disappointing Forecast Means Investors Should Avoid This Stock“:

Merck… revenue fell more than 7% year over year, missing Wall Street projections by $30 million, and Merck forecast that full-year 2015 revenue would fall more than 5% year over year. For now, investors should avoid this stock.


Pharma Patent Cliff

VACCINES AS THE GROWTH STRATEGY

 

The broader context is that the pharmaceutical industry has been reeling. Google “patent cliff” and you’ll read about the long list of chemical and biologic blockbuster drugs invented in the early to late 1990s with scheduled patent expirations rolling off from 2011 to 2019. The pipeline has been “pooping out.”

Merck itself acknowledged this impact in their announcement of 2014 financials:

Full-Year 2014 Worldwide Sales of $42.2 Billion, a Decrease of 4 Percent, Reflecting Unfavorable Impact of Patent Expiries and Divestitures and a 1 Percent Negative Impact From Foreign Exchange [emphasis mine]

 

FEAR SELLS

 

There’s been a big, bright spot for pharma in all this bad news, however.

Vaccines.

Recent reports by Markets and Markets and Research and Markets announced:

  • the global vaccine market is $33.1 billion in 2014

  • it’s expected to reach $58.9 billion by 2019

  • for a compound annual growth rate of 11.8%

  • with a longer-term outlook to surpass $100 billion by 2025

Wow. That’s one attractive business. Fear sells. Merck loves it. Gardasil was a Hail Mary pass — many lambasted its pull-out-all-the-stops marketing as manipulative and irresponsible — that not only bailed the company out of its Vioxx nightmare but emerged as one of its most profitable products ever. Pfizer is down with vaccines, too. It’s the primary reason Pfizer forked over $68 billion for Wyeth in 2009.

Check out Merck’s development pipeline. Click on “Therapeutic Areas” to narrow the search to vaccines. A new hexavalent combination shot against six diseases — diphtheria, pertussis tetanus, polio, Hib, and Hepatitis B — caught my eye.

 

BIG PEOPLE NEED SHOTS, TOO

 

We think about vaccines as mostly for children. Adults should know that we will be targeted for a lot more vaccines. Here’s a recent position paper “National Adult Immunization Plan” by the federal National Vaccine Program Office published on 2/5/15. Check out what they have to say about:

  • 2020 “healthy people target levels” by vaccine with separate goals for all adults, healthcare workers, and pregnant women (page 2)

  • expanded use of electronic health records and immunization information systems to collect and track data, and facilitate private medical records across state lines (page 13)

  • engaging employers and faith-based organizations to promote uptake (pp 15, 22)

Corporations like Merck will jump at opportunities to collaborate to increase market penetration and boost earnings. As an example, Merck is implementing a “vaccine adherence” strategy. It is partnering with an electronic health records company to give clinicians real time data access.




Can we trust Merck?

Merck has a U.S. monopoly on vaccines for measles, mumps, rubella, chickenpox, and shingles. Mainstream media likes to cut vaccine makers slack because of public health, as evidenced by recent coverage in The Atlantic and on Bloomberg. Inquiring about abuse of monopoly power is a valid question but I believe we’re really asking a broader question:

Do we trust Merck and other vaccine makers?

There are a number of issues that must be addressed when we consider this. I’ll raise four:

 

#1: EXPECT RATIONAL BEHAVIOR

 

What can we really expect from corporations that enjoy near blanket liability protection courtesy of the 1986 National Childhood Vaccine Injury Act (“1986 Act”)? My colleagues and I have addressed this point in our other work, including the bestselling book Vaccine Epidemic and my recent post: “Vaccination: Is It Time to Pull the Wool From Your Eyes?”

We should not be surprised to know that organizations behave rationally and in the case of corporations, this means behavior to maximize profitability, influence, and control. Childhood vaccines are an exceptionally attractive market:

  • Federal government recommends vaccines for virtually all children
  • All 50 state governments mandate vaccines as a condition of day care and school admission
  • Governments allocate billions of dollars for vaccine development, approval, distribution, and promotion through the NIH, FDA, CDC, state health departments, and a variety of entitlement programs
  • Vaccine makers cannot be sued for most liability associated with death and catastrophic injury following vaccination of government recommended vaccines
  • Liability protection encourages industry to develop more vaccines and get them on the ACIP childhood schedule
  • Liability protection discourages industry from making safer vaccines, whether it’s updating old shots or introducing new technologies that focus on safety
  • Liability protection discourages industry from researching potential harms caused by their vaccines

Since the 1986 Act was passed, the U.S. departed from the typical vaccines recommended by our First World peers by adding multiple doses of the following nine vaccines to the childhood schedule, starting on the day of birth:

  • 1990 Haemophilus influenzae b
  • 1991 Hepatits B
  • 1995 Chickenpox
  • 1998 Rotavirus
  • 2000 Pneumococcal
  • 2004 Influenza, Hepatitis A
  • 2006 Meningogoccal, Human Papillomavirus

I believe that passage of the 1986 Act inadvertently and directly contributed to the epidemic of pediatric chronic illness, including the constellation of medical injuries accompanying neurodevelopmental disorders that we see today.

 

#2: WHY WAS THE 1986 ACT PASSED?

 

This is an important question. What led Congress and President Reagan to deliberately bypass the Constitution and remove the right to legal recourse and due process, with the accompanying rights and remedies? It has nothing to do with children’s health and everything to do with:


We gave the pharmaceutical industry preferential treatment to continue making vaccines because we want to support domestic industry that can partner with the Defense Department on various products that might be deemed necessary for national security. Read this CDC article “Vaccines in Civilian Defense Against Bioterrorism” for a peek into some of the issues.

And while we’re on this point, check out the CDC Foundation. Yes, a government agency has its own charity. Some of the richest people and organizations donate money to huge programs for our health and safety. We can get into some of the various ways that this could lead to massive conflicts of interest and potential abuse in another post.

Ben Franklin was right about the need for eternal vigilance. We will trade liberty for a bit of safety every single time.

 

#3: WHAT ABOUT THAT REVOLVING DOOR?

 

The “revolving door” is a movement of personnel between roles as legislators and regulators and the industries affected by the legislation and regulation.

Julie Gerberding, MD was director of the CDC from 2002-2009.

  • During her tenure, the CDC added four vaccines to the recommended childhood schedule.
  • Merck happens to manufacture two of them: Hepatitis A and Gardasil (HPV).
  • Gardasil rapidly eclipsed MMR as Merck’s largest and most profitable vaccine product through exceptionally aggressive marketing. It was fast tracked through the FDA after a mere six months of trial research.
  • In 2004, whistleblower William Thompson, PhD apparently alerted Gerberding that he would be presenting results relating to statistical association between receipt of MMR vaccine and autism.

After waiting the requisite one year, to the day, Gerberding was hired as President of Merck Vaccines in January 2010.

In December 2014, she was abruptly transitioned to EVP of Strategic Communications, Global Public Policy, and Population Health. This is a new position that had not existed before.

Check out the career path of Eddy Bresnitz, MD, Merck’s Executive Director of Medical Affairs. In his capacity as NJ State epidemiologist and deputy commissioner of health, he was responsible for the addition of four new vaccine mandates in 2007, including the first ever mandated flu shot in any jurisdiction in the world.


#4: WHAT ABOUT THE MEASLES “EPIDEMIC”?

 

Who’s behind the orechestrated and relentless media “freak out,” publicizing 133 measles cases in California (out of a population of 39 million)? Let’s share information from the latest Measles Surveillance Report from the California Department of Public Health. As of 3/13/15:

  • 40 cases visited Disneyland during the period in question
  • 85% were not hospitalized
  • 56% were over the age of 20
  • 18% were between the ages of 5 to 19
  • 20 cases were between the ages of 1 and 4
  • 15 cases were under the age of 1

This affected exactly 35 kids from birth to age 4 in Ca. How is this an epidemic?

CA health officials said the recent outbreak is likely to have started from a traveler who got measles overseas not an unvaccinated child from highly unvaccinated pockets.

The media did not report that measles vaccine uptake, according to the Centers for Disease Control, is at all time high levels and has actually increased over the last 5 years that have been reported — 2009-2013.

The media did not report that many of those affected by this so-called outbreak were vaccinated, suggesting that vaccine source immunity is defective.

The media did not report that immunity from vaccination wanes over time and itself might pose a public health threat.

The media did not report that persons vaccinated with the MMR might themselves be a threat to the immunocompromised because they carry an infectious virus, the source of which is the vaccine.

The media did not report that no deaths and few hospitalizations resulted from this false epidemic of measles. Latest reports indicate the outbreak has abated.

The media failed us. Industry spokesman Paul Offit called for “journalism jail” in Forbes, for reporters who cause the public to lose confidence in vaccines, suggesting they are effectively a party to murder.

Yet, for some reason, legislators around the country, in sync with each other, have reacted with panic about what is described as a public health emergency.

Why? Who is orchestrating this campaign? Could it be Merck, the sole US manufacturer of the MMR vaccine, who has liberally distributed money to legislators and other vaccine promoters?



Lots of lawsuits

LIES ABOUT MUMPS VACCINE EFFICACY

 

As reported in Fierce Vaccines on 9/9/14, two lawsuits claiming Merck lied about the efficacy of its mumps vaccine won’t be going away anytime soon:

A federal judge in Pennsylvania refused to dismiss the suits, filed by a pair of whistleblowers and a group of doctors and payers, and now, they’re on their way to trial… [The judge] ruled that… two former Merck virologists… had sufficiently showed that the company may have misstated the vaccine’s efficacy to the government… And the direct purchasers produced enough evidence to establish that those false statements could have helped give Merck a monopoly… Now, the plaintiffs will have to prove their cases at trial.

 

$100 MILLION LAWSUIT ALLEGES “BOYS CLUB” ATMOSPHERE

 

As reported in the Star Ledger on 10/23/14, a federal judge turned back an effort by Merck lawyers to dismiss a $100 million lawsuit filed by five female employees alleging employment discrimination.

 

“THE COST OF DOING BUSINESS”

 

Like many of its pharma peers, Merck has paid out billions to settle lawsuits for marketing and other abuses. The ill-gotten profits far exceed financial penalties, causing industry watchers to comment that lawsuits are merely another line item in the budget… just an expected cost of doing business.

Drugwatch.com reports that Merck currently faces lawsuits over several products, including Fosamax, Januvia, NuvaRing and Propecia. Its most (in)famous case, however, is the Vioxx scandal. It took Merck less than one year to earn back the $4.85 billion it agreed to pay Vioxx plaintiffs. (Read All the Justice Money Can Buy – Corporate Greed on Trial.)

USA Today reported on 2/14/13 that, while denying wrongdoing, Merck agreed to settle two significant class-action lawsuits alleging it delayed negative study results for two years. It paid $688 million and took a charge of nearly a half-billion dollars against earnings.

And so it continues.



Informed Consent

Informed consent is the international human rights standard for the practice of ethical medicine as upheld by the 2005 Universal Declaration on BIoethics and Human Rights:

Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information.

There is no carve out for vaccination.

The U.S. was not one of the 192 signatories of the above document. Most parents are dismayed to learn that “There is no federal requirement for informed consent relating to immunization.” [CDC, Immunization Managers]

If you want prior, free and informed consent to vaccination, you will need to give it to yourself.



For more unindoctrinated information about vaccination see http://nexusilluminati.blogspot.com/search/label/vaccination
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