• Home
  • Victims
    • Vaccine Victims Memorial
    • Gardasil & Silgard
      • G / S Australasia
        • G / S Australia
        • G / S New Zealand
      • G / S Europe
        • G / S Czech Republic
        • G / S Denmark
        • G / S France
        • G / S Germany
        • G / S Ireland
        • G / S Italy
        • G / S Norway
        • G / S Scotland
        • G / S Spain
        • G / S United Kingdom
      • G / S N. America
        • G / S Canada
        • G / S Mexico
        • G / S United States
      • G / S S. America
        • G / S Brazil
        • G/S Colombia
    • Cervarix
      • Cervarix Asia
        • Cervarix India
        • Cervarix Philippines
      • Cervarix Europe
        • Cervarix Czech
        • Cervarix Netherlands
        • Cervarix Scotland
        • Cervarix Slovakia
        • Cervarix Spain
        • Cervarix UK
      • Cervarix N. America
        • Cervarix Mexico
  • Resources
    • HPV Testing Resources
      • Pre-HPV Vaccination
      • Post-HPV Vaccination
    • Medical Professionals
    • Vaccine Injury Attorneys
    • Political Action Groups
    • Vaccine Groups
    • Vaccine Victims Hotline
  • SANE Vax Press Releases
  • Videos
    • Vaccine Safety Videos
    • Vaccine Victim Videos
    • Pharma Videos
  • About
    • About Us
    • Who We Are
    • Press Releases
    • SANE Vax in the News
    • Contact Us

SaneVax, Inc.

The First International HPV Vaccine Information Clearinghouse

  • NEWS
    • Government Agencies
      • African
      • Asian
      • Australasian
      • European
      • North American
      • South American
      • United Nations
      • WHO
    • Pharmaceutical Companies
      • CSL Biotherapies
      • GlaxoSmithKline
      • Inovio Pharmaceuticals
      • Liquidia Technologies
      • Merck & Co.
      • Novartis
      • Pfizer
      • Qiagen
      • Sanofi Aventis
      • Sanofi Pasteur MSD spmsd
      • Wyeth Laboratories
    • Science & Medicine
      • Cancer
      • Clinical Trials
      • Environmental Health
      • Heavy Metal Toxicity
      • HPV Science
      • Influenza
      • Meningitis
      • Pertussis
      • Pharmaceuticals
      • Rotavirus
      • STD’s
      • Vaccine Science
      • Women’s Health
    • Vaccine Adverse Events
    • Vaccine Injury Reporting
      • VAERS
      • VAMPSS
    • Vaccine Litigation
    • Vaccine Marketing
    • Vaccine Politics/People
    • Vaccine Victims
      • Cervarix Injuries
      • DTP/DTaP Injuries
      • Fluvax Injuries
      • Fluzone Injuries
      • Gardasil / Silgard Injuries
      • Menomune Injuries
      • MMR Injuries
      • Polio Vaccine Injuries
      • Synflorix Injuries
      • Yellow Fever Vaccine
    • Vaccines
      • Anthrax
      • Breast Cancer
      • Chicken Pox
      • Cholera
      • Combination Vaccines
      • Diphtheria
      • Hepatitis B
      • HPV
      • Influenza Vaccines
      • Malaria
      • Measles
      • Meningitis Vaccines
      • MRSA
      • Mumps
      • Norovirus
      • Pertussis Vaccines
      • Pneumococcal Disease
      • Polio
      • Rotavirus Vaccines
      • Shingles
      • Smallpox
      • TB
      • Tetanus
      • Typhoid
      • Yellow Fever Vaccine
    • Vaccines and the Media
  • WORLD NEWS
    • Africa
    • Asia
    • Australasia
    • Europe
    • North America
    • South America
  • RESEARCH
    • Cancer Research
    • Cervarix Vaccine
    • Gardasil/Silgard Vaccine
    • Human Pap. Research
    • Immunization Practices
    • Neurology
    • Vaccine Adjuvants
    • Vac. Ingredient Research
    • Vaccine Injuries
    • Vaccine Preservatives
    • Vaccine Related Research
    • Vaccine Safety
  • CITIZENS SPEAK
    • Cervical Cancer Debate
    • HPV Vax
      • Australian Concerns
      • Canadian Concerns
      • Irish Concerns
      • Spain Concerns
      • UK Concerns
      • United States Concerns
You are here: Home / NEWS . . . . . . . . / Pharmaceutical Companies / Merck & Co. / Former Merck Scientists File Suit against Merck Under the False Claims Act

Former Merck Scientists File Suit against Merck Under the False Claims Act

June 28, 2012 By Norma Leave a Comment

By Hilary Butler, Contributing Author from New Zealand

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 doctors[1] 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 procedures,[3] 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 vaccination[4].

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[5] 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 Krah[6] in 2001, yet Merck allegedly ‘willfully’ withheld this information from multiple governments[7] 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.



[1] http://journals.cambridge.org/action/displayAbstract?fromPage=online&aid=8607503.

[2] Former Merck Virologists: suit against Merck under False Claims Act

[3] see pgs 10 and 11 – Former Merck Virologists: suit against Merck under False Claims Act

[4] see page 12 – Former Merck Virologists: suit against Merck under False Claims Act

[5] See page 22 No.64 – Former Merck Virologists: suit against Merck under False Claims Act

[6] See page 27/D 82; 28/85 and page 40 first two lines  – Former Merck Virologists: suit against Merck under False Claims Act

[7] See page 29/86 –  Former Merck Virologists: suit against Merck under False Claims Act

[8] See Page 29/87 –  Former Merck Virologists: suit against Merck under False Claims Act

Related

Filed Under: Merck & Co., MMR, Mumps, United States, Vaccine Litigation Tagged With: false claims act, federal court case, Merck

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Follow Us

SaneVax on FacebookSaneVax on TwitterSaneVax on LinkedInSaneVax on YoutubeSaneVax RSS Feed

Help Support SaneVax

Notice: We need your support. This massive research & presentation comes from a team of volunteers. We need your help to keep this critical information available.



SaneVax relies on support from participants like you. We are a 501 (c)(3) non-profit corporation, donations are tax deductible. Help keep this venue available and support the spirit – Thank you!

This Week’s Survivor

HPV vaccines are NOT good for everyone

Categories

Links

  • Creating an HPV Industry
  • File a VAERS Report
  • Gardasil and Unexplained Deaths
  • HPV Industry Timeline
  • HPV Mechanisms of Action in Women
  • HPV Vaccine Fact Sheet
  • Petition: Rescind HPV Vaccine Approval
  • Presentation to the FDA
  • Supreme Court Arguments

HPV Vaccine VAERS Reports

Description 12/14/2019  TOTAL
Disabled 3,092
Deaths 523
Did Not Recover 13,072
Abnormal Smear 695
Cervical Cancer 186
Infertility 52
Life-threatening 1,001
Emergency Room 15,419
Hospitalized 6,448
Extended Hosp. Stay 304
Serious 9,497
Total Adverse Events 64,270

Access expanded report here.

Related

Subscribe2


 

Log In

Featured Video

Gardasil Cervarix HPV Vaccine Survey

Have you or your child been given a genetically modified vaccine?

News

SaneVax News Blog!
News

Videos

Safety • Victims • Pharma
No Genetic Epidemic

Contact

Contact S.A.N.E.Vax
S.A.N.E.VAX log thumbnail

Copyright © 2023 SaneVax, Inc. · Site by TheWebElves.com a div. of KalaRhythms.org · Log in

 

Loading Comments...