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A pdf of this 30-page document is available here: http://www.courthousenews.com/2012/06/27/MerckUnsealed.pdf
Local copy: https://canadianliberty.com/documents/vaccines/MerckUnsealed.pdf

Date Filed: August 27, 2010
Court: United States District Court for the Eastern District of Pennsylvania
Civil Action No. 104374

Stephen Krahling and Joan Wlochowski bring this qui tam action as Relators on behalf of the United States against their former employer, Merck & Co., Inc. (“Merck”), under the False Claims Act, 31 U.S.C. §§ 3729-3733, and allege–upon knowledge with respect of their own acts and those they personally witnessed, and upon information and belief with respect to all other matters–as follows . . . .

In this document, Krahling and Wlochowski, virologists employed by Merck (p. 2, #3), claimed to have witnessed data falsification efforts intended to inflate the effectiveness of the mumps vaccine (p. 2, #3). They allege that Merck defrauded the U.S. government by falsely claiming a 95% effectiveness rate for its mumps vaccine (p. 1, #2). This testing was completed in 2001 (p. 19, #62).

According to the document, Merck has held an exclusive license since 1967 for its mumps vaccine, developed by Dr. Maurice Hilleman at Merck’s West Point facility. It is based on the “Jeryl Lynn” strain of the mumps virus, which was named after Hilleman’s daughter. In 1971, Merck combined its mumps vaccine with a vaccine for measles and rubella (MMR). In 1978 Merck was licensed for the MMRII vaccine, which contained a different strain of rubella.

As per the document, originally it had been necessary for Merck to demonstrate an “efficacy rate” of 95 percent or higher, and they had to repeat this standard for the license to be renewed.

This meant that the “seroconversion” rate had to be 95 percent (p. 8). For seroconversion to occur, the pre-vaccination sample has to be “negative,” meaning that there are not enough antibodies to neutralize the virus, and the post-vaccination sample has to be “positive,” meaning that there are enough antibodies to neutralize the virus. (Note: Supposedly. “Immunized” refers to counting antibodies–not to whether people actually get sick or not.)

The authors of this document claim that the mumps virus no longer has a 95% efficacy. They don’t express any other doubts about the establishment’s vaccine doctrines (including concepts such as such as “immunized” or “herd immunity”) For example, on page 5, they explain that

The FDA insists on such a high efficacy rate because only then can the disease ultimately be eradicated through what is commonly referred to as “herd immunity.” (p. 5)

“Eradicated” sounds like another religious doctrine. “95%” is based on what?

There is a claim on page 5 that there were 200,000 cases every year of mumps in the United States before the original introduction of Merck’s vaccine, and that this number dropped off after it was introduced (I would want to question the supposed causal link).

In any case, their main point is that mumps outbreaks have now occurred with those who have been vaccinated, showing the re-licensed MMRII vaccine to be ineffective.

The CDC projected that by 2010, mumps would be completely eradicated. Unfortunately, that has not happened. Beginning in 2006, there has been a resurgence in mumps outbreaks with the most recent one starting last year and ongoing now. (p. 5)

The authors (relators) say (p. 6, #20) that Merck was in danger of losing its license for MMRII if it could not still demonstrate that its vaccine was 95% effective. The authors allege that it achieved this “through manipulating its testing procedures and falsifying the test results.”

The authors state (p. 8,. #25) that Merck’s PRN test “did not test the vaccine for its ability to protect against a “wild-type” mumps virus.” Merck “tested the children’s blood for its capacity to neutralize the same Jeryl Lynn mumps strain with which the children were vaccinated.” The authors say there is a standard that Merck should have followed which tests against real-life viruses. Since they failed to do this, this is one way in which Merck “overstated the vaccine’s effectiveness” (p. 8, #25).

Even with this method of testing, the testing “yielded a seroconversion rate of only 79.5 percent”. So the PRN test was abandoned (p. 8, #26, 27).

The “second test Merck employed under Protocol 007 was formally called the Anti-IgG Enhanced Mumps Plaque Reduction Neutralization Assay.” It was begun in 2000 at Merck’s West Point facility. The relators claimed to have participated in the fraud under pressure (p. 8, #28).

To reach the stated objective for its “enhanced” test and increase the measured seroconversion rate to the predetermined 95 percent threshold, Merck continued to use its scientifically flawed PRN test but with one additional change. Merck added antibodies made in rabbits, sometimes referred to as anti-IgG, to both the pre and post-vaccination blood samples . . . (p. 10, #30).

The rabbit antibodies were added in order to increase the “virus neutralization count” post-vaccination (p. 10, #30). However, adding rabbit antibodies made the “pre-vaccination neutralization” too high, so the test results had to be falsified (p. 13, #40) claim the authors. They allege that Merck inflated the pre-vaccination plaque counts (p. 13, #41, 42).

The document alleges that senior management backed up the falsification efforts by promising large bonuses (p. 15, #46).

Krahling complained within Merck (p. 15, #47). According to the document, Krahling was threatened with jail by the Human Resources rep if he reported the allegations to the FDA (p. 15, #48 and p. 16, #50). The document alleges that evidence was destroyed. Despite the threats, “Krahling called the FDA to report this activity and Merck’s ongoing fraud (p. 16, #51).”

According to the authors, an FDA agent came to conduct a very short interview session with no follow-ups. They did not interview the accusers. The supervisors were questioned about the plaque counting method. The resulting report was focused only on record-keeping and how it explained changes to the test data. There was no inquiry into the use of rabbit antibodies or into the allegations about falsifying test data (p. 17, #54-#58).

The document points to the alleged false representation being made in the vaccine’s package inserts (p. 20, #64). The package insert for the MMRII product (revised 06/2014) can be found here: https://www.merck.com/product/usa/pi_circulars/m/mmr_ii/mmr_ii_pi.pdf
and here:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM123789.pdf

By the way, the package inserts contain important information for those who want to know more about vaccines. For example, the rubella component of the vaccine uses “WI-38 human diploid lung fibroblasts”:

“(3) MERUVAX® II (Rubella Virus Vaccine Live), the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts.”

As the legal document alleges, the following claim about 96% efficacy is contained in the package insert for MMRII:

Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that M-M-R II is highly immunogenic and generally well tolerated. In these studies, a single injection of the vaccine induced measles hemagglutination-inhibition (HI) antibodies in 95%, mumps neutralizing antibodies in 96%, and rubella HI antibodies in 99% of susceptible persons . . . ” (page 1 of package insert)

Notice point #71 (p. 22) about the European process for approving the mumps component of Merck’s vaccine products. According to this document, the EMA relied on the information submitted by Merck and “found no major concern about the efficacy of the mumps component of the vaccine.” In other words, governments don’t feel they need to do any independent tests. They rely on the information submitted by the pharmaceutical companies.

In 2006, after the relevant vaccine products had been re-approved, there were over 6500 cases of mumps in the Mid-West, which was “the largest mumps outbreak in almost twenty years.” Before that, there was an “annual average of 265 cases” (p. 23, #74-75). It was a “highly vaccinated population” (p. 24, #76)

The document cites a study by Dr. Gustavo Dan, a CDC doctor, published in the New England Journal of Medicine in 2008. He concluded that:

[a] more effective mumps vaccine or changes in vaccine policy may be needed to avert outbreaks and achieve elimination of mumps.

— Dayan, “Recent Resurgence of Mumps,” New England Journal of Medicine, 358;15 (Apr. 10, 2008) 1580. (#76, p. 24)

Another study “questioned Merck’s use of the Jeryl Lynn strain . . . “:

A vaccine failure is investigated properly only if, in addition to avidity testing, the ability of antibodies to neutralize wild mumps virus has been checked.

–Heikki Peltola, et. al., “Mumps Oubreaks in Canada and the United States: Time for New Thinking on Mumps Vaccine,” Clinical Infectious Diseases, 2007;45 (15 Aug. 2007) 459,463. (p. 24, #77)

An ongoing study at Emory University is mentioned as an effort “to explain the cause for the 2006 mumps outbreak among college-age students who had received both doses of the vaccine” (p. 24, #79).

Dr. Dayan left the CDC (U.S. government’s Center for Disease Control) and went on to work for Merck’s partner in Europe (p. 25, #81).

Dr. Gerberding, the head of the CDC during the outbreak, became president of Merck’s Vaccine Division in 2010. (p. 25, #82)

Dr. Dayan’s study also predicted a three-year cycle of outbreaks, and sure enough, another mumps outbreak began in August 2009 (3700 cases reported to the CDC as of August 2010). The outbreak happened “despite high vaccination coverage among the U.S. children’s population” (p. 25, #83-84).

Secondary Reference that also includes later cases:
http://www.huffingtonpost.ca/lawrence-solomon/merck-whistleblowers_b_5881914.html
“Merck Has Some Explaining To Do Over Its MMR Vaccine Claims”
Lawrence Solomon, huffingtonpost.ca | Sep. 25, 2014