Former Merck scientists file suit against Merck under False Claims Act

NaturalNews) On April 27, 2012, a formal complaint was filed in the Eastern Pennsylvania Federal District Court accusing Merck of a longstanding scheme to mislead and defraud Government health authorities worldwide. Two of Merck's former employees have accused the pharmaceutical giant of marketing multivalent MMR vaccines under false pretenses. According to the complaint, these vaccines have been mislabeled, misbranded, adulterated and falsely certified as having a 95% efficacy rate.

Before the lawsuit was filed, 21 doctors¹ added their voices to other groups of doctors who are calling for MMR vaccines to be used as a regular booster every 4 - 8 years, in order to control mumps outbreaks. These doctors all assume that the mumps component of all MMR vaccines have the 95 - 98% efficacy promised by Merck.

However, the court documents filed by two Merck virologists meticulously detail how Merck ostensibly manipulated test results ² for decades in order to create a false 95% efficacy rate for the mumps component of their multivalent MMR vaccines.

The former Merck virologists contend that the multivalent mumps component has a vastly reduced efficacy which is directly responsible for mumps outbreaks during the last decade which prompted international calls for MMR booster shots every 4 - 8 years.

Virologists Stephen Krahling and Joan Wlochowski describe how Merck had to recertify the mumps component in 2000, in order to comply with regulatory requirements in order for the mumps component to be included in two new multivalent MMR vaccines. The usual test, which had certified the mumps component's efficacy in the 60's, failed when used in 2000. They claim the results were so low Merck decided to change its own test protocol by testing the vaccine against the weakened mumps vaccine virus instead of the wild (naturally circulating) mumps virus.

When that modification didn't result in the desired 95% efficacy figure, Merck's executive directors of vaccine research, Drs Alan Shaw and Emilio Emini, instructed Drs David Krah and Mary Yagodich to implement a vast array of modifications to testing procedures³, then, allegedly pressured both Krahling and Wlochowski to participate.

When these modifications also failed to demonstrate the desired 95% efficacy rate, it is alleged that Drs Shaw and Emini instructed Drs Krah and Yagovich to abandon "gold standard" testing, and implement a new procedure, supposedly with the agreement of FDA, which included adding animal antibodies to human blood samples taken both pre and post vaccination⁴.

By combining the very low levels of human antibodies with animal antibodies, a much higher total level of virus neutralization was obtained than could occur from human antibodies alone. The human antibody levels alone would never protect in the real world against wild mumps. But after adding animal antibodies, the human blood samples which had previously failed under the old "gold standard" testing were retested using the "enhanced" protocols and passed with flying colors. New 'enhanced' tests showed 100% efficacy, not against wild mumps virus, but against the mumps vaccine virus.

However, combining the animal and human antibodies led to a new problem. In some of the tests more than 80% of pre-vaccine blood samples now showed up as immune. Usually, the highest number of pre-vaccine immune results any scientist could expect is 10%. Further manipulations of the animal antibody levels failed to bring the pre-vaccine blood test results down to the expected 10% levels.

According to the complaint, Merck then implemented additional 'creative' strategies to show a lack of seroconversion in immune samples in an attempt to reduce the pre-vax level to the expected 10% because had the FDA seen the high numbers of "immune" pre-vaccine samples they would have easily detected the fraudulent test procedures.

Krahling and Wlochowski worked with the same team conducting these tests, but were outraged at what they deemed to be gross scientific deception and fraudulent practices.

When Drs Krahling and Wlochowski attempted to stop what they saw as, "wholesale fabrication of test data to reach its preordained 95% efficacy threshold," Merck allegedly made various attempts to prevent them, including threatening to jail Dr. Krahling should he inform the FDA.

Despite these efforts, Dr Krahling made numerous calls to FDA. These calls remained unanswered until Dr. Krahling reported to the FDA that Dr. Krah had removed and/or destroyed Dr. Krahling's evidence.

An FDA agent then came and interviewed Dr. Krah, who apparently told the agent whatever was necessary to allay their concerns. The agent made no attempt to interview any other personnel, check any facilities, laboratory notebooks, or samples to corroborate what had been reported to them.

The lawsuit claims that to this day, Merck has consistently misrepresented the potency by simply quoting the 40 year old data from the pre-MMR monovalent mumps vaccine, thereby misrepresenting the efficacy of four multivalent vaccines: MMR, MMRII, Europe's MMRvaxpro, and ProQuad, which is MMR plus chickenpox.

According to the two whistleblowers, not only have all the multivalent MMR vaccines been sold under false pretenses, but, as a result of this LACK OF EFFICACY, there have been numerous mumps outbreaks worldwide prompting calls for regular MMR boosters throughout life. These mumps outbreaks were predicted by Merck's Dr Krah⁶in 2001, yet Merck allegedly 'willfully' withheld this information from multiple governments while consistently claiming there was no need for a new mumps component.⁸

The question is, "If the mumps component is actually 95% effective, as stated, would experts be calling for lifelong boosters every 4 - 8 years?"

Has Merck turned over a new leaf since the recent Vioxx Scandal? Do they still put profit before people? Read the complaint, follow the court case, examine the evidence, and decide for yourself.

References:
1. http://journals.cambridge.org
2. Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
3. See pgs 10 and 11 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
4. See page 12 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
5. See page 22 No. 64 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
6. See page27/d82; 28/85 and page 40 first two lines - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
7. See page 29/86 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf
8. See page 29/87 - Former Merck Virologists: suit against Merck under False Claims Act - http://sanevax.org/wp-content/uploads/2012/06/Merck-mumps-suit.pdf

By Hilary Butler, Contributing Author from New Zealand.

Please visit our site at http://sanevax.org/.


Learn more: http://www.naturalnews.com/036298_Merck_scientists_False_Claims_Act.html#ixzz1ywbgZ6om

SaneVax Reports on Another Gardasil Injury: 13 Year Old Zeda's Story

"Today, Zeda still breathes through her trach and eats with a tube. She lives her life in a hospital bed in our living room, mostly non-responsive, with round the clock care and daily nursing visits."

Nov 16, 2010 – Amy Castelbery Pingle, Indiana: When one thinks of vaccine injuries, they normally think of the person who received the vaccine. This is not the whold story. Vaccine injuries impact family, friends, and everyone around the person sho actually got the shot. Consider this story of a single mother with four children, one of whom was completely disabled after receiving Gardasil. This mother watched her daughter change from the girl in the first photo, to the girl in the second and worse. Please take time to read the story in her own words.

I am a single mother of four children, 2 boys and 2 girls. We live in Lake Station, Indiana. Before my oldest daughter Zeda got sick, we had a normal life. I worked a full-time job. 13 year old Zeda was a cheerleader and straight A student. She was also a big help to me with my other children.

I have always done my best to keep my kids healthy. I had them get their wellness check-ups and they always got whatever vaccines the doctor suggested. All my kids were completely healthy, other than the simple colds here and there. Completely healthy, that is, until it was time for Zeda's well visit on November 5th, 2008. And then her life, as she knew it, completely changed along with the rest of our family.

Zeda’s pediatrician suggested the Human Papillomavirus (HPV) or, as I know it now, the Gardasil vaccine. I thought “OK, this is what I am supposed to do to keep her healthy.” My doctor said to do it and so we did it. I knew absolutely nothing about the vaccine, other than it was for girls her age. I was not told of any side effects, other than the potential for soreness around the injection site.

A week after Zeda got the shot, she started to complain here and there, of a headache and of feeling sick to her stomach. Perhaps like some of your own daughters at her age, Zeda was a Drama Queen. So when she would tell me these things, I would tell her to lie down, murmur to her that she had probably had a long day, or I would give her some Tylenol. It never would have occurred to me that those little signs were red flags. Not until November 28th, 2008, when we were on our way to pick up her little sister from a friend's house. While in the car, Zeda kept dropping her phone. Suddenly, my son said, "Mom, I think something is wrong with Zeda!" She was crying, she was drooling, and her eyes were not looking right. She looked to me as if she had just had a seizure. I knew this because my brother had seizures. I rushed her to the ER.


This is where the confusion started with her diagnosis. First, they accused Zeda of overdosing on drugs. They yelled at her, in her face, that she needed to tell them what she had taken. I was so scared. I had no clue what was going on, and these doctors and nurses screaming at my daughter. Zeda was as scared as I was. I believe she knew that something was seriously wrong. She was confused and not able to say what she wanted. And then she had another major seizure in the middle of the ER. That is when they finally started to take us seriously. By then, they had her drug test results which were negative for any illegal drugs.

After those horrible few hours, they transferred Zeda to our local hospital, along with a pediatric neurologist and Zeda’s pediatrician. I thought we would surely get some answers there. They started running all kinds of tests. At this point, Zeda was unable to say a whole sentence; she could only say a few words at a time. She was so scared and was crying very hard. We had an MRI, a CAT scan, an EEG, and a spinal tap done. Whatever they were looking for, they did not find, all the tests were negative. The MRI did show a "shadow" on the right side of her brain, which they were now treating as viral encephalitis. But as Zeda's health deteriorated, our pediatrician continued to say she was doing this to herself, that she was "faking" it.

In the four days we were at our local hospital, Zeda had stopped talking, stopped eating, stopped walking, and was now urinating on herself. It was the nurses, NOT our doctor, who said something was truly wrong! Her symptoms were not taken seriously until a psychiatrist came in, tested her and issued a professional opinion that she wasn't faking it. One nurse suggested we go to a specialty hospital, as we were getting nowhere.
We agreed.

Within 45 minutes, we were flown to Riley Hospital for Children in Indianapolis. There, they continued to accuse her of doing this to herself. They installed 24-hour video surveillance on Zeda for about two weeks to try to catch her in the act of faking it. And they continued to perform test after test, all of which came back negative. She developed had uncontrollable movements, extremely high heart rate (up to180 bpm), high fevers including one that was 108.7 degrees, and at one point she was placed in a medical induced coma. Yet they couldn’t tell us what was wrong or why it was happening, so they instead spent most of their time blaming us and trying to prove that she was faking it. No one would go on the record to say that the Gardasil vaccine did this to Zeda.

Zeda eventually lost lung functioning and was placed on a ventilator for several months. A tracheotomy and feeding tube were put in as she could no longer eat or breathe on her own. We were at Riley Hospital for four months and her doctors still could not tell us what happened to her, only that they are sure it was not a vaccine reaction. This despite dozens of cases of similar reactions in previously healthy girls following the HPV vaccine.

Today, Zeda still breathes through her trach and eats with a tube. She lives her life in a hospital bed in our living room, mostly non-responsive, with round the clock care and daily nursing visits. This has become the defining struggle of my life… I struggle every single day to do what I can to get her better.

I am here to tell you that I didn’t know. And I think many parents are like me, and they don’t know either. I thought vaccines would keep my children safe and healthy. I didn’t know that vaccines could do this. No one ever told me. My doctor never told me the risks. I never saw anyone or anything that told me this could happen. I’m not telling you not to vaccinate. But I am telling you that people who pressure you to vaccinate don’t own the consequences. Only you, as parents, do. And if you do vaccinate, you better be really comfortable about the need for each vaccine. Because every time you vaccinate your child, there is a risk. It’s important that parents understand what’s at stake.

I deeply regret my decision to allow Zeda to get this shot. She has lost all quality of life. I would do anything to get her better, but no one has any answers for me. They still don’t believe it was the vaccine. And now that she’s sick, no one knows how to help my baby girl.

Go to http://sanevax.org/victims/gardasil-silgard-usa.shtml to read this story and many more.

Please visit our site at http://sanevax.org/.
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THE SANE VAX MISSION is to promote Safe, Affordable, Necessary & Effective vaccines and vaccination practices through education and information. We believe in science-based medicine.