Merck Accused of Lying about Vaccine Effectiveness

By Dr. Mercola

Things aren't going so well lately in the litigation department for Merck, which stands accused of lying according to not just one, but two class-action lawsuits.

In the first case, two former Merck virologists accuse their former employer of overstating the effectiveness of the mumps vaccine in Merck’s combination MMR shot, which may have cost the US government hundreds of millions of dollars over the past decadeⁱ.

Merck’s mumps vaccine was originally licensed 45 years ago. Since the 1970s, it’s been part of the trivalent measles, mumps and rubella (MMR) vaccine, which is part of the recommended childhood vaccination schedule.  The case, which was initially filed in 2010, was unsealed late last month. As reported by the Courthouse News Serviceⁱⁱ:

“... Stephen Krahling and Joan Wlochowski were Merck virologists who claim in their unsealed complaint that they "witnessed firsthand the improper testing and data falsification in which Merck engaged to artificially inflate the vaccine's efficacy findings."

... As the largest single purchaser of childhood vaccines (accounting for more than 50 percent of all vaccine purchases), the United States is by far the largest financial victim of Merck's fraud," according to the 2010 False Claims Act complaint.”

According to Nasdaq.comⁱⁱⁱ:

“Merck--which stressed that none of these allegations relate to the safety of its product--said the lawsuit is "completely without merit", and that it plans to "vigorously defend itself."

It’s quite interesting to note the chosen language in Merck’s rebuttal. It in no way addresses the issue of the vaccine’s effectiveness, which is the core issue of the lawsuit and the allegation by the two former Merck employees that the drug company purposefully used improper testing methods and falsified data to make the mumps vaccine appear highly effective when the opposite was true. Instead, Merck responds by saying that none of the lawsuit’s allegations relate to the safety of its products. Such evasive maneuvering certainly gives the appearance of an admission of guilt.

Second Lawsuit Filed

A mere week after the first case was unsealed, a federal antitrust class action lawsuit was filed by Chatom Primary Care. According to Courthouse News Service^iv:

“Merck has known for a decade that its mumps vaccine is "far less effective" than it tells the government, and it falsified test results and sold millions of doses of "questionable efficacy," flooding and monopolizing the market, a primary caregiver claims in a federal antitrust class action.

 ... Chatom says in its antitrust complaint that Merck falsely claims its mumps vaccine is 95 percent effective. That claim "deterred and excluded competing manufacturers," who would enter the risky and expensive vaccine market only if they believed they could craft a better product...  

Merck is the only manufacturer licensed by the FDA to sell the mumps vaccine in United States, and if it could not show that the vaccine was 95 percent effective, it risked losing its lucrative monopoly... That's why Merck found it critically important to keep claiming such a high efficacy rate, the complaint states. And, Chatom claims, that's why Merck went to great lengths, including "manipulating its test procedures and falsifying the test results," to prop up the bogus figure, though it knew that the attenuated virus from which it created the vaccine had been altered over the years during the manufacturing process, and that the quality of the vaccine had degraded as a result.”

According to these two lawsuits, Merck began a sham testing program in the late 1990’s to hide the declining efficacy of the vaccine. The objective of the fraudulent trials was to "report efficacy of 95 percent or higher regardless of the vaccine's true efficacy." This program was initially referred to as “Protocol 007,” the Chatom claim states, and instead of testing the vaccine’s efficacy against a wild mumps virus, as is the norm, Merck used its own attenuated strain of the virus—the identical strain with which the children were being vaccinated!  

That’s as brilliant as it is devious, and a perfect example of how medical research can be manipulated to achieve desired results. Suzanne Humphries recently wrote an excellent summary for GreenMedInfo.com, explaining in layman's terms how the tests were manipulated (see Sources).The two virologists bringing the lawsuit against Merck claim they witnessed firsthand this deception and were asked to directly participate in it.

As reported by the Courthouse News Service^v:

“That "subverted" the purpose of the testing regime, "which was to measure the vaccine's ability to provide protection against a disease-causing mumps virus that a child would actually face in real life. The end result of this deviation ... was that Merck's test overstated the vaccine's effectiveness," Chatom claims.     

Merck also added animal antibodies to blood samples to achieve more favorable test results, though it knew that the human immune system would never produce such antibodies, and that the antibodies created a laboratory testing scenario that "did not in any way correspond to, correlate with, or represent real life ... virus neutralization in vaccinated people," according to the complaint.

Chatom claims that the falsification of test results occurred "with the knowledge, authority and approval of Merck's senior management."

Health versus Profits

Considering the extent of the allegations here, it is really shocking that the conventional media has not picked up on this story.  About the only major media source reporting on it was Forbes Magazine^vi

Interestingly, Forbes stated that this case gives “vaccine foes” new ammunition for their argument that drug companies are more interested in money than protecting consumers’ health. And rightfully so. While I do not advocate indiscriminately abstaining from all vaccines—I  strongly advise and encourage exercising due diligence because vaccines can cause serious reactions that can have such devastating consequences. I believe in informed consent and the freedom to choose. There can be little doubt anymore that drug companies are in it for the profits, and virtually no price seems too high for them when it comes to protecting their profit-making.  

I’ve written extensively about the many criminal and ethical wrongdoings of Big Pharma, and this is certainly not the first shocking allegation of pharmaceutical product manufacturing fraud that involves launching or keeping an inferior and/or dangerous product on the market.

While vaccine makers often claim there’s not a lot of profit to be had in vaccines, you have to remember that vaccine patents do not expire like drugs do. Vaccines continue to make profits as long as they’re in use, so risk of future losses due to competition is virtually nonexistent. So of course there’s profit in vaccines—especially once it’s placed on the childhood vaccination schedule because that guarantees the vaccine will have a stable, guaranteed annual market as a new cohort of babies are born every year. And of course vaccine makers will protect those huge profits—even, apparently, when it means putting children’s health at risk.

There is also the issue of immunity from prosecution. Merck lost many billions when their drug, Vioxx, killed tens of thousands of people and was taken off the market in 2004.  If any of their vaccines killed similar numbers, or even more, they would not be held liable in damages for a single cent because Congress and the U.S. Supreme Court have completely shielded big drug companies like Merck from civil liability for vaccine injuries and deaths.

Also you need to remember that IF a vaccine is indeed highly effective, and avoiding the disease in question is worth the risk of the potential side effects from the vaccine, then it could be said that the benefits outweigh the risks. However, if the vaccine is ineffective(and/or the disease doesn’t pose a great threat to begin with), then the vaccine may pose an unacceptable risk... At the very least, an ineffective vaccine will certainly skew the benefit to risk ratio toward greater risk, unless the vaccine is guaranteed harmless, and this, I’m afraid, cannot be said for the MMR.

This, I believe, is one of the most important points to remember in this discussion.

It’s not so much about determining whether or not the reduced effectiveness of this vaccine allowed the mumps outbreaks of 2006 and 2009 to occur, both of which occurred in highly vaccinated communities, but rather it’s a question of: “Have millions of children taken an unnecessary health risk by being injected with an ineffective vaccine?”

“Nothing Matters More than Safety,” Merck Says

“Nothing is more important to Merck than the safety and effectiveness of our vaccines and medicines and the people who use them,” Forbes quotes a Merck spokesman^vii.

Really?

Then WHY did they heavily promote Vioxx and keep it on the market until it had killed more than 60,000 people? I warned my readers that this pain killer might be a real killer for some people, five years before Merck made its $30 billion recall! Five years they let it go, and they undoubtedly would have kept it on the market longer had the lethal dangers not become so shockingly obvious to other scientists.

After Vioxx came the HPV vaccine Gardasil—perhaps the most unnecessary vaccine ever created, and likely one of the most dangerous to boot. Merck claims their main concern is safety... They must be speaking about some parallel Universe, because ever since Gardasil’s approval in 2006, reports of life-altering side effects and sudden deaths of otherwise healthy teenagers have stacked up into the thousands, yet Merck steadfastly refuses to acknowledge or address these health risks.

Gardasil appears to have one of the highest risk to benefit ratios of any vaccine on the market, and India even halted Merck’s post-licensing trials of the vaccine after four young participants died, yet Merck has the gall to claim that nothing is more important to them than safety. Give me a break... Actions speak louder than words, and Merck has a long paper trail of litigation highlighting the company’s questionable ethics.

Did Ineffective MMR Vaccine Promote Mumps Outbreaks?

In 2009, more than 1,000 people in New Jersey and New York came down with mumps. At the time, questions arose about the effectiveness of the vaccine as 77 percent of those sickened were vaccinated. No vaccine is ever 100 percent effective, of course, and according to the CDC, the MMR was estimated to be somewhere between 76-95 percent effective. In fact, the second MMR dose is necessary because up to 20 percent of individuals do not develop measles immunity after the first dose. The second dose is intended to provide a “second chance” for the vaccine to work, which is further evidence of this shot’s ineffectiveness.

A similar scenario occurred in 2006, when mumps infected more than 6,500 people in the US. Most of those cases also occurred among the vaccinated population, primarily among college students who had received two doses of MMR vaccine. About the only people who were truly immune to mumps were older Americans who had recovered from mumps as children, and therefore had received natural, lifelong immunity.

But just how and why did these outbreaks occur?

Typically, vaccine promoters will stress the importance of compliance with the vaccine schedule that requires multiple doses of a vaccine in order to create and maintain vaccine induced "herd immunity," because a vaccine is never 100 percent effective. However, they never quite seem to be able to explain why the majority of outbreaks occur in areas that are thought to HAVE herd immunity status, i.e. where the majority of people are vaccinated and "should" therefore never get the disease.

What You Need to Know about "Herd Immunity"

The problem is that there is in fact such a thing as natural herd immunity. But what they've done is they've taken this natural phenomenon and assume that vaccines will work the same way. However, they do not, and the science clearly shows that there's a big difference between naturally arising herd immunity and vaccine-induced herd immunity. To learn more, I urge you to listen to the following video, in which Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC), discusses the concept of herd immunity.

Download Interview Transcript

Barbara explains:

"The original concept of herd immunity is that when a population experiences the natural disease… natural immunity would be achieved – a robust, qualitatively superior natural herd immunity within the population, which would then protect other people from getting the disease in other age groups. It's the way infectious diseases work…" Barbara explains. "But the vaccinologists have adopted this idea of vaccine induced herd immunity.

The problem with it is that all vaccines only confer temporary protection… Pertussis vaccine is one the best examples… Pertussis vaccines have been used for about 50 to 60 years, and the organism has started to evolve to become vaccine resistant. I think this is not something that's really understood generally by the public: Vaccines do not confer the same type of immunity that natural exposure to the disease does."

Vaccine professionals would like you to believe they are the same, but they're qualitatively two entirely different types of immune responses.

"In most cases natural exposure to disease would give you a longer lasting, more robust, qualitatively superior immunity because it gives you both cell mediated immunity and humoral immunity," Barbara explains. "Humoral is the antibody production. The way you measure vaccine-induced immunity is by how high the antibody titers are. (How many antibodies you have, basically.)

But the problem is, the cell mediated immunity is very important as well. Most vaccines evade cell mediated immunity and go straight for the antibodies, which is only one part of immunity. That's been the big problem with the production of vaccines."

Vaccines are designed to trick your body's immune system into producing the antibodies needed to resist any future infection. However, your body is smarter than that. The artificial stimulation of your immune system produced by an attenuated or dead virus simply is not the same as your body engaging with and overcoming the real live virus.

According to Barbara:

"The fact that manmade vaccines cannot replicate the body's natural experience with the disease is one of the key points of contention between those who insist that mankind cannot live without mass use of multiple vaccines and those who believe that mankind's biological integrity will be severely compromised by their continued use.

... [I]s it better to protect children against infectious disease early in life through temporary immunity from a vaccine, or are they better off contracting certain contagious infections in childhood and attaining permanent immunity? Do vaccine complications ultimately cause more chronic illness and death than infectious diseases do? These questions essentially pit trust in human intervention against trust in nature and the natural order, which existed long before vaccines were created by man."

More Censored News: MMR Vaccine Caused Autism, Italian Court Rules

These two lawsuits couldn’t come at a more precarious time for Merck, as the Italian Health Ministry has conceded the MMR vaccine caused autism in a now nine-year old boy. As a result, a court in Rimini, Italy recently awarded the family a 15-year annuity totaling 174,000 Euros (just under $220,000), plus reimbursement for court costs, ruling that the boy "has been damaged by irreversible complications due to vaccination (prophylaxis trivalent MMR)."

According to The Daily Mail, a British paper^viii:  

"Judge Lucio Ardigo, awarding compensation to the family... said it was ‘conclusively established’ that Valentino had suffered from an ‘autistic disorder associated with medium cognitive delay’ and his illness, as Dr Barboni stated, was linked to receiving the jab.   Lawyer Mr Ventaloro explained yesterday: ‘This is very significant for Britain which uses, and has used, an MMR vaccine with the same components as the one given to Valentino. ‘It is wrong for governments and their health authorities to exert strong pressure on parents to take children for the MMR jab while ignoring that this vaccine can cause autism and linked conditions.’

Claudio Simion, a leading member of the lobby group Association for Freedom of Choice in Vaccination (Comilva), adds: ‘The Rimini judgment is vitally important for children everywhere. The numbers with autism are growing. It is a terrible thing that the authorities turn a blind eye to the connection between the MMR vaccination and this illness.’”

The UK newspaper, The Independent^ix, also reported on this groundbreaking case, stating that about 100 similar cases are now being examined by Italian lawyers, and more may be brought to court.

"Luca Ventaloro the family lawyer, said yesterday: "This is very significant for Britain which uses, and has used, an MMR vaccine with the same components as the one given to Valentino. It is wrong for governments and their health authorities to exert strong pressure on parents to take children for the MMR jab while ignoring that this vaccine can cause autism and linked conditions." The number of autism cases has risen sharply since the 1970s, with one in 64 British children affected," The Independent reported.

One can speculate about the reason why this news story was not picked up by a single US media outlet when it happened, but if I was a gambling man, I’d place my bet on protecting the vaccination program—not because it’s a marvelous panacea that promotes optimal health and longevity and can be defended with raw facts and first-class science, but because it’s a major profit center, both for the vaccine makers and for those whose pockets are lined with Big Pharma greenbacks in return for promoting and protecting the industry’s golden goose.

Even More Bad News: U.S. Varicella Vaccination Program a Total Flop

In related news, a recent review of the varicella (chickenpox) vaccination program in the U.S. concluded that the vaccine has:

• Not proven to be cost-effective
• Increased the incidence of shingles
• Failed to provide long-term protection from the disease it targets?chicken pox?and
• Is less effective than the natural immunity that existed in the general population before the vaccine

Here, vaccine efficacy was found to have declined well below 80 percent by of 2002. This damning news was published in May in the journal Vaccine^x.

The information was gathered from a review of chicken pox and shingles statistics in the years since the vaccine was introduced. The researchers point out that although statistics showed shingles rates increased after the vaccine, “CDC authorities still claimed” that no increase had occurred. The authors also state that the CDC not only ignored the natural boost in immunity to the community that occurred with wild chickenpox, as opposed to the vaccine, but also ignored the “rare serious events following varicella vaccination” as well as the increasing rates of shingles among adults:

“In the prelicensure era, 95% of adults experienced natural chickenpox (usually as children)—these cases were usually benign and resulted in long-term immunity. Varicella vaccination is less effective than the natural immunity that existed in prevaccine communities. Universal varicella vaccination has not proven to be cost-effective as increased herpes zoster [shingles] morbidity has disproportionately offset cost savings associated with reductions in varicella disease. Universal varicella vaccination has failed to provide long-term protection from VZV disease.”

Get Informed Before You Vaccinate

Stories such as these underscore the importance to take control of your own health, and that of your children. It’s simply not wise to blindly depend on the information coming directly from the vaccine makers’ PR departments, or from federal health officials and agencies that are mired in conflicts of interest with industry...

No matter what vaccination choices you make for yourself or your family, there is a basic human right to be fully informed about all risks of medical interventions and pharmaceutical products, like vaccines, and have the freedom to refuse if you conclude the benefits do not outweigh the risks for you or your child.

Unfortunately, the business partnership between government health agencies and vaccine manufacturers is too close and is getting out of hand. There is a lot of discrimination against Americans, who want to be free to exercise their human right to informed consent when it comes to making voluntary decisions about which vaccines they and their children use.

We cannot allow that to continue.

It's vitally important to know and exercise your legal rights and to understand your options when it comes to using vaccines and prescription drugs. For example, your doctor is legally obligated to provide you with the CDC Vaccine Information Statement (VIS) sheet and discuss the potential symptoms of side effects of the vaccination(s) you or your child receive BEFORE vaccination takes place. If someone giving a vaccine does not do this, it is a violation of federal law. Furthermore, the National Childhood Vaccine Injury Act of 1986 also requires doctors and other vaccine providers to:

• Keep a permanent record of all vaccines given and the manufacturer's name and lot number
• Write down serious health problems, hospitalizations, injuries and deaths that occur after vaccination in the patient's permanent medical record
• File an official report of all serious health problems, hospitalizations, injuries and deaths following vaccination to the federal Vaccine Adverse Events Reporting System (VAERS)

If a vaccine provider fails to inform, record or report, it is a violation of federal law. It's important to get all the facts before making your decision about vaccination; and to understand that you have the legal right to opt out of using a vaccine that you do not want you or your child to receive. At present, all 50 states allow a medical exemption to vaccination (medical exemptions must be approved by an M.D. or D.O.); 48 states allow a religious exemption to vaccination; and 18 states allow a personal, philosophical or conscientious belief exemption to vaccination.

However, vaccine exemptions are under attack in a number of states, and it's in everyone's best interest to protect the right to make informed, voluntary vaccination decisions.

What You Can Do to Make a Difference

While it seems "old-fashioned," the only truly effective actions you can take to protect the right to informed consent to vaccination and expand your rights under the law to make voluntary vaccine choices, is to get personally involved with your state legislators and the leaders in your community.

THINK GLOBALLY, ACT LOCALLY.

Mass vaccination policies are made at the federal level but vaccine laws are made at the state level, and it is at the state level where your action to protect your vaccine choice rights will have the greatest impact.

Signing up to be a user of NVIC's free online Advocacy Portal at www.NVICAdvocacy.org gives you access to practical, useful information to help you become an effective vaccine choice advocate in your own community. You will get real-time Action Alerts about what you can do if there are threats to vaccine exemptions in your state. With the click of a mouse or one touch on a Smartphone screen you will be put in touch with YOUR elected representatives so you can let them know how you feel and what you want them to do. Plus, when national vaccine issues come up, you will have all the information you need to make sure your voice is heard. So please, as your first step, sign up for the NVIC Advocacy Portal.

Right now, in California, the personal belief exemption is under attack by Pharma-funded medical trade organizations and public health officials trying to get a bill (AB 2109) passed that would require parents to get a medical doctor's signature to file an exemption for personal religious and conscientious beliefs. Watch NVIC's 90-second public service message and learn more about what you can do if you are a California resident.

Internet Resources

To learn more about vaccines, I encourage you to visit the following web pages on the National Vaccine Information Center (NVIC) website at www.NVIC.org:

• NVIC Memorial for Vaccine Victims: View descriptions and photos of children and adults, who have suffered vaccine reactions, injuries and deaths. If you or your child experiences an adverse vaccine event, please consider posting and sharing your story here.
• If You Vaccinate, Ask 8 Questions: Learn how to recognize vaccine reaction symptoms and prevent vaccine injuries.
• Vaccine Freedom Wall: View or post descriptions of harassment by doctors or state officials for making independent vaccine choices.
• Vaccine Ingredient Calculator (VIC): Find out just how much aluminum, mercury and other ingredients are in the vaccines your doctor is recommending for you or your child.
• Vaccine Adverse Events Reporting System (VAERS) on MedAlerts. Search the government's VAERS database to find out what kinds of vaccine reactions, injuries and deaths have been reported by patients and heath care workers giving vaccines.

Find a Doctor Who will Listen to Your Concerns

Last but not least, if your pediatrician or doctor refuses to provide medical care to you or your child unless you agree to get vaccines you don't want, I strongly encourage you to have the courage to find another doctor. Harassment, intimidation, and refusal of medical care is becoming the modus operandi of the medical establishment in an effort to punish those patients and parents, who become truly educated about health and vaccination and want to make vaccine choices instead of being forced to follow risky one-size-fits-all vaccine policies.

If you are treated with disrespect or are harassed in any way by a doctor (or government official), do not engage in an unproductive argument. You may want to contact an attorney, your elected state representatives or local media, if you or your child are threatened.

That said, there is hope.

At least 15 percent of young doctors recently polled admit that they're starting to adopt a more individualized approach to vaccinations in direct response to the vaccine safety concerns of parents. It is good news that there is a growing number of smart young doctors, who prefer to work as partners with parents in making personalized vaccine decisions for children, including delaying vaccinations or giving children fewer vaccines on the same day or continuing to provide medical care for those families, who decline use of one or more vaccines.

So take the time to locate and connect with a doctor who treats you with compassion and respect and is willing to work with you to do what is right for your child, and isn't just competing for government incentives designed to increase vaccination rates at any cost.

References:

i United States District Court for the Eastern District of Pennsylvania, Civil Action No: 10 4374, August 27, 2010 ii Courthouse News Service June 27, 2012 iii Nasdaq.com June 22, 2012 iv See ref 2 v See ref 2 vi Forbes Magazine June 27, 2012 vii See ref 6 viii The Daily Mail June 16, 2012 ix The Independent June 17, 2012 x Vaccine May 31, 2012 [Epub ahead of print]

http://www.foodconsumer.org/newsite/Non-food/Drug/vaccine_effectiveness_0709120959.html